Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018)

[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Proposed Rules]
[Pages 47686-47762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19599]

[[Page 47685]]

Vol. 83

Thursday,

No. 183

September 20, 2018

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 403, 416, 418, et al.

Medicare and Medicaid Programs; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction; Proposed Rule

Federal Register / Vol. 83 , No. 183 / Thursday, September 20, 2018 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 488,
491, and 494

[CMS-3346-P]
RIN 0938-AT23

Medicare and Medicaid Programs; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would reform Medicare regulations that are
identified as unnecessary, obsolete, or excessively burdensome on
health care providers and suppliers. This proposed rule would increase
the ability of health care professionals to devote resources to
improving patient care by eliminating or reducing requirements that
impede quality patient care or that divert resources away from
furnishing high quality patient care.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on November 19,
2018.

ADDRESSES: In commenting, please refer to file code CMS-3346-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3346-P, P.O. Box 8010,
Baltimore, MD 21244-1810.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3346-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Alpha-Banu Wilson, (410) 786-8687. We
have also included a subject matter expert under the ``Provisions of
the Proposed Rule'' section for each provision set out in the proposed
rule.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that website to view public comments.

Table of Contents

To assist readers in referencing sections contained in this
preamble, we are providing a Table of Contents.

I. Executive Summary and Background
A. Purpose
B. Summary of Major Provisions
C. Summary of Costs and Benefits
II. Provisions of the Proposed Regulations
A. Religious Nonmedical Health Care Institutions (RNHCIs)--
Discharge Planning (Sec. 403.736(a) and (b))
B. Ambulatory Surgical Centers
C. Hospice
D. Hospitals
E. Transplant Centers
F. Home Health Agencies
G. Comprehensive Outpatient Rehabilitation Facility (CORF)--
Utilization Review Plan (Sec. 485.66)
H. Critical Access Hospitals
I. Community Mental Health Center (Sec. 485.914(d))
J. Portable X-Ray Services (Sec. 486.104(a) and 486.106(a))
K. Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs)
L. Emergency Preparedness for Providers and Suppliers
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Sources of Data Used in Estimates of Burden Hours and Cost
Estimates
D. Anticipated Effects
E. Alternatives Considered
F. Uncertainty
G. Accounting Statement and Table
H. Reducing Regulation and Controlling Regulatory Costs
I. Conclusion

I. Executive Summary and Background

A. Purpose

Over the past several years, we have revised the Conditions of
Participation (CoPs) and Conditions for Coverage (CfCs) to reduce the
regulatory burden on providers and suppliers while preserving health
and safety. We identified obsolete and burdensome regulations that
could be eliminated or reformed to improve effectiveness or reduce
unnecessary reporting requirements and other costs, with a particular
focus on freeing up resources that health care providers, health plans,
and States could use to improve or enhance patient health and safety.
We also examined policies and practices not codified in rules that
could be changed or streamlined to achieve better outcomes for patients
while reducing burden on providers and suppliers of care, and we
identified non-regulatory changes to increase transparency and to
become a better business partner. In addition, the Centers for Medicare
& Medicaid Services (CMS) and the Department of Health and Human
Services (HHS) have reaffirmed their commitment to the vision of
creating an environment where agencies incorporate and integrate the
ongoing retrospective review of regulations into Department operations
to achieve a more streamlined and effective regulatory framework. The
objectives were to improve the quality of existing regulations
consistent with statutory requirements; streamline procedural solutions
for businesses to enter and operate in the marketplace; maximize net
benefits (including benefits that are difficult to quantify); and
reduce costs and other burdens on businesses to comply with
regulations.
In accordance with these goals, we published three final rules that
identified unnecessary, obsolete, or excessively burdensome regulations
on health care providers, suppliers, and beneficiaries. These rules
further increased the ability of health care professionals to devote
resources to improving patient care by eliminating or reducing
requirements that impede quality patient care or that divert providing
high quality patient care:
``Reform of Hospital and Critical Access Hospital
Conditions of Participation'', published May 16, 2012 (77 FR 29034);
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction'', published May 16, 2012 (77 FR
29002) and;
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and

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Burden Reduction; Part II'', published May 12, 2014 (79 FR 27105).
This proposed rule is a continuation of our efforts to reduce
regulatory burden and is in accordance with the January 30, 2017
Executive Order ``Reducing Regulation and Controlling Regulatory
Costs'' (Executive Order 13771). We propose changes to the current
requirements, CoPs, and Conditions for Coverage (CfCs) that will
simplify and streamline the current regulations and thereby increase
provider flexibility and reduce excessively burdensome regulations,
while also allowing providers to focus on providing high-quality
healthcare to their patients. This proposed rule will also reduce the
frequency of certain required activities and, where appropriate, revise
timelines for certain requirements for providers and suppliers and
remove obsolete, duplicative, or unnecessary requirements. Ultimately,
these proposals balance patient safety and quality, while also
providing broad regulatory relief for providers and suppliers.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on Medicare and Medicaid participating
providers and suppliers and create cost savings, while also preserving
quality of care and patient health and safety. Consistent with our
``Patients Over Paperwork'' Initiative, we are particularly interested
in any suggestions to improve existing requirements, within our
statutory authority, where they make providing quality care difficult
or less effective. We also note that such suggestions could include or
expand upon comments submitted in response to Requests for Information
(RFIs) that were included in the 2017 prospective payment regulations
for most provider types. We refer readers to the public comments that
were submitted in response to the RFI for the following 2017 payment
regulations:
End-Stage Renal Disease Prospective Payment System and
Payment for Renal Dialysis Services Furnished to Individuals with Acute
Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
found at https://www.regulations.gov/docket?D=CMS-2017-0084.
CY 2018 Home Health Prospective Payment System Rate
Update; Value-Based Purchasing Model; and Quality Reporting
Requirements found at https://www.regulations.gov/docket?D=CMS-2017-0100.
FY 2018 Hospice Wage Index and Payment Rate Update and
Hospice Quality found at https://www.regulations.gov/document?D=CMS-2017-0062-0001.
FY 2018 Hospital Inpatient Prospective Payment System for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System RFI, found at https://www.regulations.gov/docket?D=CMS-2017-0055.
CY 2018 Hospital Outpatient PPS Policy Changes and Payment
Rates and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates found at https://www.regulations.gov/docket?D=CMS-2017-0091.
FY 2018 Inpatient Rehabilitation Facility Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0059-0002.
FY 2018 Inpatient Psychiatric Facilities Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2018-0053-0002.
CY 2018 Revisions to Payment Policies under the Physician
Fee Schedule and Other Revisions to Part B found at https://www.regulations.gov/docket?D=CMS-2017-0092.
FY 2018 Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities found at https://www.regulations.gov/document?D=CMS-2017-0060-0002.
Public comments on the RFIs can be found by searching for the terms
``RFI'' or ``request for information'' in the aforementioned 2017
payment regulation dockets on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.

B. Summary of Major Provisions

We propose to reduce regulatory burden on providers and suppliers
by modifying, removing, or streamlining current regulations that we now
believe are excessively burdensome. The proposals fall under three
categories: (1) Proposals that simplify and streamline processes, (2)
proposals that reduce the frequency of activities and revise timelines,
and (3) proposals that are obsolete, duplicative, or that contain
unnecessary requirements, as follows.
1. Proposals That Simplify and Streamline Processes
a. Discharge Planning in Religious Nonmedical Health Care Institutions
(RNHCIs)
We have concluded that a more condensed and flexible process for
discharge planning for RNHCIs would reduce burden and simplify the
discharge process for patients. Specifically, we propose to revise the
requirements at 42 CFR 403.736(a), requiring an evaluation, and Sec.
403.736(b), requiring a discharge plan. Instead of specifying detailed
discharge processes, we would simply require RNHCIs to assess the need
for a discharge plan for any patient identified as likely to suffer
adverse consequences if there is no plan, and provide discharge
instructions to the patient and the patient's caregiver as necessary
when the patient is discharged home.
b. Ambulatory Surgical Center (ASC): Transfer Agreements With Hospitals
We propose to remove the requirements at 42 CFR 416.41(b)(3),
``Standard: Hospitalization.'' This would address the competition
barriers that currently exist in some situations where hospitals
providing outpatient surgical services refuse to sign written transfer
agreements or grant admitting privileges to physicians performing
surgery in an ambulatory surgical center (ASC). The Emergency Medical
Treatment and Labor Act emergency response regulations would continue
to address emergency transfer of a patient from an ASC to a nearby
hospital.
c. ASC Requirements for Comprehensive Medical History and Physical
Assessment
We propose to remove the current requirements at Sec. 416.52(a)
and replace them with requirements that defer, to a certain extent, to
the ASC policy and operating physician's clinical judgment to ensure
that patients receive the appropriate pre-surgical assessments tailored
to the patient and the type of surgery being performed. We still would
require the operating physician to document any pre-existing medical
conditions and appropriate test results, in the medical record, which
would have to be considered before, during and after surgery. In
addition, we have retained the requirement that all pre-surgical
assessments include documentation regarding any allergies to drugs and
biologicals, and that the medical history and physical examination
(H&P), if completed, be

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placed in the patient's medical record prior to the surgical procedure.
d. Hospice Requirements for Medication Management
We have concluded that the requirements at 42 CFR 418.106(a)(1),
related to having on the hospice staff, an individual with specialty
knowledge of hospice medications, is no longer necessary for various
reasons. Therefore, we propose to remove these requirements.
In addition, we propose to replace the requirement that hospices
provide a copy of medication policies and procedures to patients,
families and caregivers with a requirement that hospices provide
information regarding the use, storage, and disposal of controlled
drugs to the patient or patient representative, and family. This
information would be provided in a more user-friendly manner, as
determined by each hospice. We believe this could improve patients' and
caregivers' comprehension and maximize the effectiveness of the
education effort.
e. Hospice Requirements: Orientation of Skilled Nursing Facility (SNF)
and Intermediate Care Facilities for Individuals With Intellectual
Disabilities (ICF/IID) Staff
We propose to move the requirements at Sec. 418.112(f) to the
``Written agreement'' standard at new Sec. 418.112(c)(10). Moving the
requirement for facility staff orientation from a standalone
requirement that places responsibility solely on hospices to the
section of the rule related to the written agreement established
between hospices and skilled nursing facilities (SNFs) and intermediate
care facilities for individuals with intellectual disabilities (ICFs/
IID) will allow both entities to negotiate the terms for assuring
orientation of facility staff. This will give hospices more freedom to
develop innovative approaches and avoid effort duplication with other
hospices that are orienting the same facility staff.
f. Hospital Quality Assessment and Performance Improvement Program
(QAPI Program)
We propose a new standard at 42 CFR 482.21(f), ``Unified and
integrated QAPI program for multi-hospital systems.'' We would allow a
hospital that was part of a hospital system consisting of multiple
separately certified hospitals using a system governing body that was
legally responsible for the conduct of two or more hospitals, the
system governing body could elect to have a unified and integrated
Quality Assessment and Performance Improvement (QAPI) program for all
of its member hospitals after determining that such a decision was in
accordance with all applicable State and local laws. The system
governing body is responsible and accountable for ensuring that each of
its separately certified hospitals meets all of the requirements of
this section. Each separately certified hospital within the system
would have to demonstrate that: The unified and integrated QAPI program
was established in a manner that takes into account each member
hospital's unique circumstances and any significant differences in
patient populations and services offered in each hospital; and the
unified and integrated QAPI program would establish and implement
policies and procedures to ensure that the needs and concerns of each
of its separately certified hospitals, regardless of practice or
location, were given due consideration, and that the unified and
integrated QAPI program would have mechanisms in place to ensure that
issues localized to particular hospitals were duly considered and
addressed.
g. Hospital Requirements for Comprehensive Medical History and Physical
Examinations (Sec. Sec. 482.22, 482.24, and 482.51)
We propose to allow hospitals the flexibility to establish a
medical staff policy describing the circumstances under which such
hospitals could utilize a pre-surgery/pre-procedure assessment for an
outpatient, instead of a comprehensive medical history and physical
examination (H&P). We believe that the burden on the hospital, the
practitioner, and the patient could be greatly reduced by allowing this
option. In order to exercise this option, a hospital would need to
document the assessment in a patient's medical record. The hospital's
policy would have to consider patient age, diagnoses, the type and
number of surgeries and procedures scheduled to be performed,
comorbidities, and the level of anesthesia required for the surgery or
procedure; nationally recognized guidelines and standards of practice
for assessment of specific types of patients prior to specific
outpatient surgeries and procedures; and applicable state and local
health and safety laws.
h. Hospital Infection Control Program
We propose a new standard at Sec. 482.42(c), ``Unified and
integrated infection control program for multi-hospital systems.'' Like
the proposed requirements for a unified and integrated QAPI program,
the proposed standard for infection control would allow a hospital that
is part of a hospital system consisting of multiple separately
certified hospitals using a system governing body that is legally
responsible for the conduct of two or more hospitals, the system
governing body can elect to have a unified and integrated infection
control program for all of its member hospitals after determining that
such a decision is in accordance with all applicable State and local
laws. The system governing body is responsible and accountable for
ensuring that each of its separately certified hospitals meets all of
the requirements of this section. Each separately certified hospital
within the system must demonstrate that: The unified and integrated
infection control program is established in a manner that takes into
account each member hospital's unique circumstances and any significant
differences in patient populations and services offered in each
hospital; the unified and integrated infection control program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration, and
that the unified and integrated infection control program has
mechanisms in place to ensure that issues localized to particular
hospitals are duly considered and addressed; and a qualified individual
(or individuals) has been designated at the hospital as responsible for
communicating with the unified infection control program and for
implementing and maintaining the policies and procedures governing
infection control as directed by the unified infection control program.
i. Special Requirements for Psychiatric Hospitals
We propose at Sec. 482.61(d) to clarify the scope of authority for
non-physician practitioners or Doctor of Medicine Doctor of Osteopathic
Medicine (MD/DOs) to document progress notes of patients receiving
services in psychiatric hospitals.
j. Special Requirement for Transplant Centers and Definitions
We are proposing a nomenclature change at part 482 and the
transplant center regulations at Sec. Sec. 482.68, 482.70, 482.72
through 482.104, and at Sec. 488.61. This change would update the
terminology used in the regulations to conform to the terminology that
is widely used and understood within the transplant community, thereby
reducing provider confusion.

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k. Data Submission, Clinical Experience, and Outcome Requirements for
Re-Approval of Transplant Centers
We propose to remove the requirements at Sec. 482.82 that require
transplant centers to submit clinical experience, outcomes, and other
data in order to obtain Medicare re-approval. Transplant centers will
still be required to comply with the CoPs at Sec. Sec. 482.72 through
482.104 and the data submission, clinical experience, and outcome
requirements for initial Medicare approval under Sec. 482.80.
l. Special Procedures for Approval and Re-Approval of Organ Transplant
Centers
We propose to remove the requirements at Sec. 488.61(f) through
(h) with respect to the re-approval process for transplant centers.
This change corresponds to the proposed removal of the provisions Sec.
482.82.
m. HHA Requirements for Verbal Notification of Patient Rights and
Responsibilities
We propose to remove the requirements for verbal (meaning spoken)
notification of patient rights to those patient rights elements for
which the Social Security Act (the Act) requires such verbal
notification. Specifically, we propose to only require verbal notice
for those rights related to payments made by Medicare, Medicaid, and
other federally funded programs, and potential patient financial
liabilities.
n. Personnel Requirements for Portable X-Ray Technologists
We propose to revise Sec. 486.104, ``Condition for coverage:
Qualifications, orientation and health of technical personnel'', to
align the current requirements at Sec. 486.104(a)(1), (2), (3), (4)
with Sec. 482.26(c)(2), which refers to qualifications of radiologic
technologists in hospitals and is focused on the qualifications of the
individual performing services.
o. Portable X-Ray Requirements for Orders
We propose to revise the requirements for portable x-ray orders at
Sec. 486.106(a)(2). We propose to remove the requirement that
physician or non-physician practitioner's orders for portable x-ray
services must be written and signed. We also propose to replace the
specific requirements related to the content of each portable x-ray
order with a cross-reference to the requirements at 42 CFR 410.32,
which also apply to portable x-ray services. These proposed changes
would simplify the ordering process for portable x-rays and promote the
use of more efficient ordering methods, such as electronic orders.
p. Emergency Preparedness Requirements: Requirements for Emergency
Plans
We propose to eliminate part of the requirement from Sec.
482.15(a)(4) for hospitals and other parallel provisions for other
affected Medicare and Medicaid providers and suppliers (referred to
collectively as ``facilities,'' throughout the remainder of this
proposed rule where applicable), that facilities document efforts to
contact local, tribal, regional, State, and Federal emergency
preparedness officials, and that facilities document their
participation in collaborative and cooperative planning efforts. In
accordance with the remaining requirement at Sec. 482.15(a)(4),
facilities would still be required to include a process for cooperation
and collaboration with local, tribal, regional, State and Federal
emergency preparedness officials' efforts to maintain an integrated
response during a disaster or emergency situation. Only the
documentation requirements would be eliminated.
2. Proposals That Reduce the Frequency of Activities and Revise
Timelines
a. Home Health Agency (HHA) Requirements for Providing Patients With
Copies of Clinical Records
We propose to remove the requirement that Home Health Agencies
(HHAs) provide a copy of the clinical record to a patient, upon
request, by the next home visit. We propose to retain the requirement
that the copy of the clinical record must be provided, upon request,
within 4 business days.
b. CAH Annual Review of Policies and Procedures
We propose to change the requirement at Sec. 485.635(a)(4) to
reflect the current medical practice where providers are expected to
update their policies and procedures as needed in response to
regulatory changes, changes in the standard of care, or nationally
recognized guidelines. The current CoP at Sec. 485.635(a)(4) requires
a CAH's professional personnel to review its policies at least annually
and the CAH to review as necessary. We propose to reduce burden and
provide flexibility by requiring the CAH's, professional personnel, at
a minimum, to conduct a biennial review of its policies and procedures
instead of an annual review.
c. Comprehensive Outpatient Rehabilitation Facility (CORF) Utilization
Review Plans
We propose to amend the utilization review plan requirements at
Sec. 485.66 to reduce the frequency of utilization reviews from
quarterly to annually. This would allow an entire year to collect and
analyze data to inform changes to the facility and the services
provided.
d. Community Mental Health Center (CMHC) Requirements for Updating the
Client Assessment
We propose to remove the requirement that all Community Mental
Health Center (CMHC) clients receive an updated assessment every 30
days. Instead, we would require updates of the patient assessment in
accordance with client needs and standards of practice. For clients
receiving partial hospitalization services, we propose to retain the 30
day assessment update time frame in accordance with existing Medicare
payment requirements for partial hospitalization services.
e. RHC and FQHC Review of Patient Care Policies
We propose to revise the requirement at Sec. 491.9(b)(4) that RHC
and FQHC patient care policies are reviewed at least annually by a
group of professional personnel to review every other year to reduce
the frequency of policy reviews.
f. RHC and FQHC Program Evaluation
We propose to revise the requirement at Sec. 491.11(a) by changing
the frequency of the required RHC or FQHC evaluation from annually to
every other year.
g. Emergency Preparedness Requirements: Requirements for Annual Review
of Emergency Program
On September 16, 2016, we finalized a rule imposing emergency
preparedness requirements on most Medicare and Medicaid facilities
(Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers, 81 FR 63860). Facilities
participating in Medicare and/or Medicaid are now required, among other
things, to review their emergency preparedness programs annually. This
includes a review of their emergency plans, policies and procedures,
communication plans, and training and testing programs. We propose to
revise these requirements, so that applicable providers and suppliers
have increased flexibility with compliance.

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h. Emergency Preparedness Requirements: Requirements for Training
As with the review of the emergency plan previously discussed, we
propose to revise the requirement that facilities develop and maintain
a training program based on the facility's emergency plan annually.
Instead, we would require that facilities provide training biennially
(every 2 years) after facilities conduct initial training for their
emergency program. In addition, we propose to require additional
training when the emergency plan is significantly updated.
i. Emergency Preparedness Requirements: Requirements for Testing
For inpatient providers, we propose to expand the types of
acceptable testing exercises that may be conducted such that one of the
two annually required testing exercises may be an exercise of their
choice, which may include one community-based full-scale exercise, if
available, an individual facility-based functional exercise, a drill,
or a tabletop exercise or workshop that includes a group discussion led
by a facilitator. For outpatient providers, we propose to revise the
requirement such that only one testing exercise is required annually,
which may be either one community-based full-scale exercise, if
available, or an individual facility-based functional exercise, every
other year and in the opposite years, these providers may chose the
testing exercise of their choice which may include a community-based
full-scale exercise, if available, a facility-based functional
exercise, a drill, or a tabletop exercise or workshop that includes a
group discussion led by a facilitator.
3. Proposals That Are Obsolete, Duplicative, or That Contain
Unnecessary Requirements
a. Hospice Aide Training and Competency Requirements
We propose to revise Sec. 418.76(a)(1)(iv) to remove the
requirement that a State licensure program meet the specific training
and competency requirements set forth in Sec. 418.76(b) and (c) in
order for such licensure to qualify a hospice aide to work at a
Medicare-participating hospice. We would defer to State licensure
requirements regardless of their content or format, and would allow
states to set forth training and competency requirements that meet the
needs of their populations. We believe that this change would
streamline the hiring process for most hospices.
b. Medical Staff: Autopsies
We propose to remove the requirement for hospitals at Sec.
482.22(d), which states that a hospital's medical staff should attempt
to secure autopsies in all cases of unusual deaths and of medical-legal
and educational interest. We propose to instead defer to State law
regarding such medical-legal requirements.
c. Hospital and CAH Swing-Bed Requirements
We propose to remove the cross reference to Sec. 483.10(f)(9) at
Sec. 482.58(b)(1) (for hospital swing-bed providers) and Sec.
485.645(d)(1) (for CAH swing-bed providers). The cross-reference gives
a resident the right to choose to, or refuse to, perform services for
the facility if they so choose. If the resident works, the facility
must document it in the resident's plan of care, noting whether the
services are voluntary or paid, and, if paid, providing wages for the
work being performed, at prevailing rates.
We propose to remove the cross-reference to Sec. 483.24(c) at
Sec. 482.58(b)(4) (for hospital swing-bed providers) and Sec.
485.645(d)(4) (for CAH swing-bed providers). This cross reference
requires that the facility provide an ongoing activity program based on
the resident's comprehensive assessment and care plan directed by a
type of qualified professional specified in the regulation.
We propose to remove the cross-reference to Sec. 483.70(p) at
Sec. 482.58(b)(5) (for hospital swing-bed providers) and Sec.
485.645(d)(5) (for CAH swing-bed providers requiring facilities with
more than 120 beds to employ a social worker on full-time basis).
We propose to remove the cross-reference to Sec. 483.55(a)(1) at
Sec. 482.58(b)(8) (for hospital swing-bed providers) and Sec.
485.645(d)(8) (for CAH swing-bed providers) requiring that the facility
assist residents in obtaining routine and 24-hour emergency dental
care.
d. Home Health Agency Home Health Aide Supervision Requirements
We propose to revise the requirement at Sec. 418.76(h) related to
completing a full competency evaluation when an aide is found to be
deficient in one or more skills. Instead of completing a full
competency evaluation, an aide would only be required to complete
retraining and a competency evaluation directly related to the
deficient skills.
e. CAH Disclosure Requirements
We propose to remove Sec. 485.627(b)(1), the requirement for CAHs
to disclose the names of people with a financial interest in the CAH.
This is currently a requirement under the program integrity
requirements at 42 CFR 420.206, which are referenced in the provider
agreement rules in 42 CFR 489.53(a)(8). The provider agreement rules
note that the basis for termination of the provider agreement includes
failure of the provider to furnish ownership information as required in
Sec. 420.206, making this CAH CoP requirement duplicative of those
regulations.

C. Summary of Costs and Benefits

1. Overall Impact
This proposed rule would create savings and reduce burden in many
areas. Several of the proposed changes would create measurable monetary
savings for providers and suppliers, while others would create less
quantifiable savings of time and administrative burden. We estimate a
total annual savings of $1,123 million using the midpoints of estimated
ranges. We also estimate a one-time implementation cost of $64 million.
2. Section-by-Section Economic Impact Estimates
Table 1 summarizes the provisions for which we are able to provide
specific estimates for savings or burden reductions (these estimates
are uncertain and could be substantially higher or lower, as explained
in the regulatory impact analysis section of this proposed rule):

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Table 1--Summary of Costs and Benefits
----------------------------------------------------------------------------------------------------------------
Estimated
Number of annual
Provider or supplier type and description of Frequency affected savings or
proposed provisions entities benefits
($millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care Institution:
Discharge Planning............... As patients are discharged 18 (*)
(Estimated 619 annual
discharges).
Ambulatory Surgical Center:
Governing Body and Management.... Upon failed hospital transfer 5,557 (*)
agreement attempts.
Patient Admission, Assessment and Every patient admission to an \1\ 5,557 454
Discharge (History and Physical) **. ASC or hospital outpatient. \2\ 5,031
Medical Records.................. Recurring annually.............. 5,557 0
Hospices:
Drugs and Biologicals, Medical Recurring annually.............. 1,151 80
Supplies, and Durable Medical Equipment.
Hospices That Provide Hospice Recurring annually.............. 4,602 (*)
Care to residents of a SNF/NF or ICF/IID.
Hospice Aide and Homemaker Recurring annually.............. 3,498 2
Services.
Hospitals:
Quality Assessment and Recurring annually.............. 5,031 28
Performance Improvement Program.
Medical staff: Autopsies......... Recurring annually.............. 5,031 0
Infection Control................ Recurring annually.............. 5,031 105
Special requirements for hospital Recurring annually.............. 5,031 30
providers of long-term care services
(``swing-beds'').
Special Requirements for Recurring annually.............. 574 62
Psychiatric Hospitals.
Transplant Programs:
Various provisions related to Recurring annually.............. 750 (\3\)
performance ***.
Home Health Agencies:
Patient rights................... Recurring annually.............. 12,624 55
Home health aide services........ Recurring annually.............. 12,624 0
Clinical records................. Recurring annually.............. 12,624 0
Critical Access Hospitals:
Provision of Services............ Recurring biennially............ 1,343 2
Organizational structure......... Recurring annually.............. 1,343 (*)
Special requirements for hospital Recurring annually.............. 1,246 86
providers of long-term care services
(``swing-beds'').
Comprehensive Outpatient Rehabilitation
Facilities:
Utilization Review Plan.......... Recurring annually.............. 188 (*)
Community Mental Health Centers:
Assessment Update................ Recurring annually.............. 52 (*)
Portable X-Ray Services:
Qualifications of X-ray Annual.......................... 500 31
technicians ***.
Removing written orders.......... Annual.......................... 500 29
RHC (4,160 clinics) & FQHC (7,874 center
locations):
Provision of Services............ Recurring biennially............ 12,034 7
Program Evaluation............... Recurring biennially............ 12,034 9
Emergency Preparedness for Providers and
Suppliers:
Annual Review of Emergency Recurring annually.............. 72,844 94
Preparedness Program.
Emergency Plan................... Recurring annually.............. 68,254 7
Training and Testing-Training Recurring annually.............. 69,196 33
Program.
Training and Testing-Testing..... Recurring annually.............. 36,971 9
-------------------------------
Total Annual Savings.................. ................................ .............. 1,123
Life-extending benefits for transplant ................................ .............. (\3\)
patients **.
----------------------------------------------------------------------------------------------------------------
* Amount is less than 1 million dollars.
** These include proposed changes to the following requirements: Special Requirements for Transplant Programs;
Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and
Special Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will increase in future years.
\1\ (ACSs).
\2\ (Hospitals).
\3\ Not Quantified.

[[Page 47692]]

II. Provisions of the Proposed Regulations

A. Religious Nonmedical Health Care Institutions (RNHCIs)--Discharge
Planning (Sec. 403.736(a) and (b))

Section 1861(ss)(1) of the Act defines the term ``Religious
Nonmedical Health Care Institution'' (RNHCI) and lists the requirements
that a RNHCI must meet to be eligible for Medicare participation. We
have implemented these provisions in 42 CFR part 403, subpart G,
``Religious Nonmedical Health Care Institutions Benefits, Conditions of
Participation, and Payment.'' Currently there are 18 Medicare-certified
RNHCIs that are subject to the RNHCI regulations.
A RNHCI provides only non-medical items and services through non-
medical nursing personnel on a 24-hour basis. These services are
provided to beneficiaries who choose to rely solely upon a religious
method of healing and for whom the acceptance of medical services would
be inconsistent with their religious beliefs. ``Religious non-medical
care'' or ``religious method of healing'' means care provided under
established religious tenets that prohibit conventional or
unconventional medical care for the treatment of the patient, and
exclusive reliance on religious activity to fulfill a patient's total
healthcare needs. The RNHCI does not furnish medical screening,
examination, diagnosis, prognosis, treatment, or the administration of
drugs or biologicals to its patients.
Section 403.736(a) and (b) of the RNHCI's CoPs, as amended in the
November 28, 2003 Federal Register (68 FR 66710), requires RNHCIs to
have a discharge planning process for patients. We reviewed the current
CoPs and payment for RNHCIs at 42 CFR part 403, subpart G, in an effort
to reduce burden and provide flexibility as feasible. As a result of
the review, we identified discharge planning as one area where we could
reduce burden. The current discharge planning requirements at Sec.
403.736(a) and (b) require RNHCIs to have a discharge planning process
that applies to all patients, and to assure that appropriate post-
institution services are obtained for each patient, as necessary.
Currently, Sec. 403.736(a)(1) requires RNHCIs to assess the need
for a discharge plan for any patient identified as likely to suffer
adverse consequences if there is no planning and for any other patient
upon his or her request or at the request of his or her legal
representative. In accordance with Sec. 403.736, this discharge
planning evaluation must be initiated at admission and must include the
following:
An assessment of the possibility of a patient needing
post-RNHCI services and of the availability of those services.
An assessment of the probability of a patient's capacity
for self-care or of the possibility of the patient being cared for in
the environment from which he or she entered the RNHCI.
The staff must complete the assessment on a timely basis
so that arrangements for post-RNHCI care are made before discharge and
so that unnecessary delays in discharge are avoided.
The discharge planning evaluation must be included in the
patient's care record for use in establishing an appropriate discharge
plan. Staff must discuss the results of the discharge planning
evaluation with the patient or a legal representative acting on his or
her behalf.
If the discharge planning evaluation indicates a need for
a discharge plan, qualified and experienced personnel must develop or
supervise the development of the plan.
In the absence of a finding by the RNHCI that the
beneficiary needs a discharge plan, the beneficiary or his or her legal
representative may request a discharge plan. In this case, the RNHCI
must develop a discharge plan for the beneficiary.
The RNHCI must arrange for the initial implementation of
the beneficiary's discharge plan.
If there are factors that may affect continuing care needs
or the appropriateness of the discharge plan, the RNHCI must reevaluate
the beneficiary's discharge plan. The RNHCI must inform the beneficiary
or legal representative about the beneficiary's post-RNHCI care
requirements.
The discharge plan must inform the beneficiary or his or
her legal representative about the freedom to choose among providers of
care when a variety of providers is available that are willing to
respect the discharge preferences of the beneficiary or legal
representative.
Since the RNHCI's religious tenets prohibit conventional or
unconventional medical treatment of a beneficiary, we believe that the
extensive requirements previously discussed are unnecessarily
burdensome, because medical post-institution services are not utilized
by RNHCI patients.
Based on our experience with RNHCIs, patients are routinely
discharged to home and not to an acute or post-acute care medical
provider or supplier. We do not see a need for RNHCIs to develop a
discharge plan that includes medical care once a patient leaves the
RNHCI, because doing so is not in keeping with the religious tenets and
goals of the facility. However, we believe that it is important to
discuss with the caregiver at home about a safe and healing environment
at home and to monitor the individual to access any changes in the
patient's well-being and the need to seek additional care. We would
expect RNHCIs to have policies and procedures that address their
discharge processes. If the RNHCI determines that a patient either does
or does not require discharge instructions, this decision must be made
based on the RNHCI's existing policies. Surveyors would be expected to
review the RNHCI policies and confirm that either the existence or lack
of discharge instructions is consistent with policies established by
the RNHCI.
We propose a more condensed and flexible process for discharge
planning and instructions for RNHCIs. Specifically, we propose to
remove the requirements at Sec. 403.736(a) and (b), proposing instead
to require RNHCIs to provide discharge instructions to the patient and/
or the patient's caregiver when the patient is discharged home. We also
propose that paragraphs (c) and (d) be redesignated as paragraphs (b)
and (c).
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction for future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on RNHCIs and create cost savings, while
also preserving quality of care and patient health and safety.
Consistent with our ``Patients Over Paperwork'' Initiative, we are
particularly interested in any suggestions to improve existing
requirements, within our statutory authority, where they make providing
quality care difficult or less effective.
We also note that such suggestions could include or expand upon
comments submitted in response to the FY 2018 Hospital Inpatient
Prospective Payment System for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System RFI, found at https://www.regulations.gov/docket?D=CMS-2017-0055. Public comments on the RFI
can be found by searching for the terms ``RFI'' or ``request for
information'' in the aforementioned 2017 payment

[[Page 47693]]

regulation docket on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: Mary Collins, (410) 786-3189.

B. Ambulatory Surgical Centers

Section 416.2 defines an ambulatory surgical center (ASC) as any
distinct entity that operates exclusively for the purpose of providing
surgical services to patients not requiring hospitalization, in which
the expected duration of services would not exceed 24 hours following
an admission. The surgical services performed at ASCs are scheduled,
primarily elective, non-life-threatening procedures that can be safely
performed in an ambulatory setting. Currently, there are 5,591 Medicare
certified ASCs in the United States.
Section 1832(a)(2)(F)(i) of the Act specifies that ASCs must meet
health, safety, and other requirements specified by the Secretary in
regulation in order to participate in Medicare. The Secretary of the
Department of Health and Human Services (the Secretary) is responsible
for ensuring that the CfCs protect the health and safety of all
individuals treated by ASCs, whether they are Medicare beneficiaries or
other patients.
The ASC regulations were first published on August 5, 1982 (47 FR
34082) and have since been amended several times. On November 18, 2008,
we published a final rule, entitled ``Medicare Program: Changes to the
Ambulatory Surgical Center Conditions for Coverage'', (73 FR 68502)
revising four existing health and safety CfCs and created three new
health and safety CfCs. In addition, several other small changes have
been made in the past several years to amend the emergency equipment
requirements (77 FR 29002) and radiologic services requirements
required in the ASCs (79 FR 27106).
1. Governing Body and Management (Sec. 416.41(b)(3)(i) and (ii))
Hospitalization Requirements
Section 416.41(b) outlines the patient hospitalization procedures
that ASCs must have in place to participate in Medicare. Section
416.41(b)(1) states the ASC must have an effective procedure for the
immediate transfer, to a hospital, of patients requiring emergency
medical care that surpass the capabilities of the ASC. Additionally,
there are two requirements that also pertain to ASC patient hospital
transfers. Section 416.41(b)(3)(i) and (ii) requires ASCs to have a
written transfer agreement with a hospital that meets certain Medicare
requirements or ensure all physicians performing surgery in the ASC
have admitting privileges in a hospital that meets certain Medicare
requirements. A written transfer agreement and physician admitting
privileges is intended to make sure there is a relationship between the
ASC and local hospital that would serve the patient in the event of a
medical emergency. Over the past 5 years, we have heard from the
largest ASC trade association and multiple ASCs that we need to address
the widespread issue of the growing number of hospitals that are
declining to work with ASCs (either by declining to sign a transfer
agreement or by declining to allow admitting privileges to the hospital
by physicians who work in ASCs) due to competition between hospital
outpatient surgery departments and ASCs. CMS has continually worked
with the ASCs and hospitals directly to resolve this requirement issue,
however, several facilities have not been able to reach a positive
outcome. Furthermore, we have seen no evidence of negative patient
outcomes due to a lack of such transfer agreements and admitting
privileges. Research reports published by the ASC Quality Collaborative
indicate the national hospital transfer rate from an ASC to a hospital
for care is about 1.25 per 1,000 ASC admissions (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ASC-Quality-Reporting/index.html). ASCs are already required to have
personnel trained and available for emergency response when there is a
patient in the ASC. In addition, the ASC is expected to provide initial
stabilizing treatment until the patient is transferred. Finally, the
current requirement dates back to 1982, when ASCs were a newly emerging
medical care option and there was reasonable concern as to needed
emergency care being available.
EMTALA was enacted in 1986 and as its enforcement evolved over time
this effectively has rendered such transfer agreements unnecessary,
since EMTALA imposed requirements on all hospitals to provide emergency
care without regard to prior arrangements until a patient could be
stabilized and, as appropriate, either discharged because further care
was not necessary, or transferred to another facility or care
arrangement. Therefore, we conclude that these requirements are
creating an administrative barrier to efficient ASC operations without
any improvement in patient care or safety. In the absence of a transfer
agreement or admitting privileges, ASCs would continue to have access
to local emergency services to transfer patients to the nearest
appropriate hospital for continued care. Hospitals are required to
provide appropriate screening and stabilizing treatment for patients
experiencing emergency medical conditions in accordance with the
regulations set forth at Sec. 489.24.
In light of these factors, we propose to remove the requirement for
a written hospital transfer agreement or hospital physician admitting
privileges at Sec. 416.41(b)(3). We believe the proposed changes to
the ASC hospitalization standard requirements would streamline ASC
administrative operations and still assure the safety of these services
while being less burdensome for Medicare-certified ASC facilities. The
requirements in Sec. 416.41(b)(1) and (2) continue to require the ASC
to have an effective procedure for the immediate transfer, to a
hospital, of patients requiring emergency medical care beyond the
capabilities of the ASC and that the hospital must be a local hospital
that meets the requirements for payment for emergency services under
Sec. 482.2. As part of this effective procedure, ASCs are not
precluded from obtaining a hospital transfer agreements or hospital
physician admitting privileges when possible. We would also like to
solicit comments on burden that may result from the absence of a
transfer agreement between ASCs and hospitals.
2. Patient Admission, Assessment and Discharge (Sec. 416.52(a)(1),
(2), (3) and (4))
The current regulations at Sec. 416.52 require ASCs to ensure that
a physician or other qualified practitioner provide a comprehensive
medical history and physical assessment completed not more than 30 days
before the date of the scheduled surgery. We have received feedback
from stakeholders that the current requirement is overly burdensome for
a large majority of healthy patients, specifically those patients who
are receiving minimally invasive surgical procedures that are performed
under minimal sedation or local anesthesia alone. For example, cataract
surgery is the most commonly performed ASC surgical procedure among
Medicare beneficiaries. Modern cataract surgery is a short procedure
using mild sedation and local anesthesia. Medical complications for
cataract surgery before, during and after surgery are extremely rare.
Other ophthalmic procedures, such as Yttrium-Aluminum Garnet (YAG)
laser capsulotomy, does not require a local

[[Page 47694]]

anesthetic and is a painless 60 second procedure that can be completed
during a routine patient visit. However, when it is performed in an
ASC, which enables one laser to be utilized by multiple surgeons for
procedures, the requirement for a history and physical is burdensome to
the patient and medical staff without any additional benefits. One
study published in the New England Journal of Medicine concluded that
routine preoperative medical testing (blood counts, clotting studies,
chemistry panels, electrocardiograms, chest x-ray, etc.) conferred no
measurable value in reducing adverse medical events on the day of
surgery or up to one week postoperatively (Schein OD, Katz J, Bass EB,
et al. Study of Medical Testing for Cataract Surgery. The value of
routine preoperative medical testing before cataract surgery. New
England Journal of Medicine. 2000; 342(3): 168-75). Another article on
this issue from the Cochrane Database of Systematic Reviews reviewed
three randomized clinical trials and also found that routine
preoperative testing did not increase the safety of cataract surgery
(Keay L, Lindsley K, Tielsch J, Katz J, and Schein O. Routine
preoperative medical testing for cataract surgery, 2012;3:CD007293).
These results are consistently found for other ambulatory surgeries.
For example, one study tested over one thousand patients over a wide
range of surgeries and found no increase in adverse events as a result
of no preoperative testing (Chung F, Yuan H, Yin L, Vairavanathan S,
and Wong DT. Elimination of preoperative testing in ambulatory surgery.
Anaesth Analg. 2009 Feb: 108(s):467-75). Another and much larger study
reviewed the literature on a broad range of ambulatory surgeries and
examined records of results for over 73,000 patients who underwent
various hernia surgeries and found that preoperative testing was not
associated with rates of postoperative complications.
The vast majority of outpatient surgeries are performed on an
outpatient or ``ambulatory'' basis precisely because they involve
extremely low risk of complications due either to preexisting
conditions or to the risk of the surgical procedure itself. Most such
procedures are among those that are also routinely performed in
physician offices. We further note that the specification of any short
time period for the acceptability of pre-surgical evaluations (in other
words, within 30 days) is inherently arbitrary and burdensome for the
ASC patient population. For example, in the case of a cataract patient
who needs a procedure in both eyes, a 31-day delay between the two
operations would trigger the need for another physical examination and,
possibly, another set of laboratory tests. Likewise, if an
unanticipated event such as a death in the family required delaying a
procedure by more than the 30th day after the examination, a
duplicative examination and any necessary tests would be required.
Moreover, if the examination and tests had been performed timely, but
the results not transmitted in time, the duplicative examination and
tests would be required.
We propose to remove the current requirements at Sec. 416.52(a)
and replace them with requirements that defer to the facility's
established policies for pre-surgical medical histories and physical
examinations (including any associated testing) and the operating
physician's clinical judgment, to ensure patients receive the
appropriate pre-surgical assessments that are tailored for the patient
and the type of surgery being performed. We propose to require each ASC
to establish and implement a policy that identifies patients who
require an H&P prior to surgery. We propose that the policy would
include the time frame for the H&P to be completed prior to surgery.
ASCs may choose to continue the 30 day policy that has existed in
regulation since 2008, or may choose a different time frame based on
available evidence and standards of practice. We propose that the
policy would be required to consider the age of patients, their
diagnoses, the type and number of surgeries that are scheduled to be
performed at one time, all known comorbidities, and the planned level
of anesthesia for the surgery to be performed. ASCs would not be
limited to these factors, and would be permitted to include others to
meet the needs of their patient populations. Furthermore, we propose
that each ASC's policy would be required to follow nationally
recognized standards of practice and guidelines, as well as applicable
state and local health and safety laws.
Particular subgroups of patients may benefit from more extensive
and complete medical history and physical assessments prior to surgery.
Those subgroups, for example, might include patients who cannot lie
supine, have chest pain or shortness of breath, have pacemakers, have
had a recent heart attack, on dialysis, or take insulin (Schein OD,
Pronovost PJ. A Preoperative Medical History and Physical Should Not Be
a Requirement for All Cataract Patients. DOI: 10.1007/s11606-017-4043-
9, March 20, 2017.)
We would retain the requirement that the physician performing the
surgery or other qualified practitioner perform a pre-surgical
assessment for each ASC patient, including documentation regarding any
allergies to drugs and biologicals. We would also retain the
requirement that any documentation related to the H&P that may have
been performed would be placed in the patient's medical record prior to
the surgical procedure.
Our proposed change would simply eliminate the requirement for a
pre-operative H&P, while allowing patient-specific physician decisions
and ASC-wide policy decisions to determine what examinations and tests
are necessary for each patient. Such decisions could be informed by
specialty societies, medical literature, past experience, or other
factors. We believe the proposed changes will reduce burden and provide
flexibility for patients while maintaining a balance of health and
safety requirements for providers.
In reading the discussion that follows, it is important to
understand that the requirement for making a patient assessment at the
ASC, on the day of surgery and before surgery commences, remains
unchanged. This assessment addresses any new surgical risks for the
patient with procedure-specific or patient-specific questions (for
example, has the patient had a fever in the last 24 hours or, for a
patient with diabetes, have there been any recent changes to random
blood glucose levels with at-home monitoring?). The questions focus on
any recent changes or updates to the patient's condition since the last
H&P that might adversely impact the outcome of the procedure for the
patient. This assessment must occur before proceeding with the
procedure. Furthermore, we are not proposing to eliminate or discourage
comprehensive pre-surgical H&Ps where warranted. To replace the current
arbitrary 30-day rule applying to all patients, regardless of procedure
or risk, we propose that each facility make an independent
determination as to which procedures and which patient profiles would
dictate requiring a pre-operative history and examination, taken before
(but not necessarily 30 days before and possibly many months before)
the day of surgery.
We request comment on whether we should make exceptions, such as
for particular patient conditions or surgical procedures, that should
not be entitled to such broad discretion, and for any evidence that
would support such exceptions. We would also be interested in knowing
if particular examinations or tests should be normal for those

[[Page 47695]]

conditions or procedures, and whether such standards would need be
imposed by regulation or could rely on physician and facility judgment
and practices.
3. Medical Records (Sec. 416.47)
The current regulations at Sec. 416.47 require ASCs to maintain
complete, comprehensive, and accurate medical records to ensure
adequate patient care. Section 416.47(b) sets out the form and content
of the record, including specific items that must be included in the
medical record. To conform to the proposed changes to the medical
history and physical examination requirements at Sec. 416.52(a), we
propose to revise the requirement at Sec. 416.47(b)(2) that states
``Significant medical history and results of physical examination'', by
adding ``as applicable.'' This proposed revision would reflect the fact
that, in accordance with our proposed changes to Sec. 416.52(a), not
all ASC patients may have a medical history and physical examination
report that would be included in the medical record.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on ASCs and create cost savings, while also
preserving quality of care and patient health and safety. Consistent
with our ``Patients Over Paperwork'' Initiative, we are particularly
interested in any suggestions to improve existing requirements, within
our statutory authority, where they make providing quality care
difficult or less effective. We also note that such suggestions could
include or expand upon comments submitted in response to the RFI that
was included in the CY 2018 OPPS/ASC proposed rule. Public comments in
response to this RFI can be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0091. Public comments on the RFI
can be found by searching for the terms ``RFI'' or ``request for
information'' in the aforementioned 2017 payment regulation docket on
www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.

C. Hospice

1. Hospice Aide and Homemaker Services (Sec. 418.76)
Under the current hospice CoP requirements at Sec. 418.76, all
hospice aides are required to meet specific, federally-established,
training and education requirements. The requirements are based on the
training and education requirements for home health aides as set forth
at section 1891(a)(3)(D) and 1861(m)(4) of the Act. Specifically, the
current CoPs (Sec. 418.76(a)) require that a hospice aide must be a
person who has completed one of the following: A training program and
competency evaluation as specified in the regulations; a competency
evaluation program that meets the requirements specified in the
regulation; a nurse aide training and competency evaluation program in
accordance with the requirements set forth in the long term care
requirements; or a State licensure program that meets the requirements
at Sec. 418.76(b) (training) and (c) (competency evaluation). At Sec.
418.76(b) and (c) of the hospice CoPs, we specifically detail the
content and format of aide education, training, and of competency
evaluations, including the number of classroom and practical training
hours that must be completed, the skills that must be addressed, and
the general method (exam or practical observation) used for assessing
competency in those various skills.
We initially proposed and finalized these requirements in order to
be consistent with the requirements that apply to home health aides
(Sec. 484.80). Historically, a significant number of hospice agencies
were HHA-based, meaning that the same entity provides both hospice and
home health care services, often utilizing the same pool of staff to
furnish both services. Using similar requirements for both hospices and
home health agencies streamlines operations for hospices that are home
health agency based. Due to the evolution of the hospice industry as a
whole, the proportion of HHA-based hospices has significantly declined,
reducing the streamlining benefits that occur by having the same
requirements for aides in both hospice and home health settings.
As the streamlining benefits for the hospice industry as a whole
have reduced, the burden/benefit ratio related to meeting the
prescriptive home health aide qualification requirements, which are
required to be set forth in regulation by section 1891(a) of the Act,
has shifted. While section 1891(a) of the Act requires CMS to establish
prescriptive requirements for aides who provide services on behalf of
home health agencies, the Act does not establish similarly prescriptive
requirements for aides who provide services on behalf of hospices. In
addition to the hospice aide qualifications that are established in the
hospice CoPs, hospice aides must also be licensed, certified, or
registered by the State in which they are practicing (if available), in
accordance with the requirements at Sec. 418.116(a). A hospice
industry association conducted an informal survey of all 50 states and
found that 76 percent of those states currently have their own hospice
aide qualifications for licensure, certification, or registration.
Therefore, we assume that in 76 percent of states, hospice aides are
required to meet two different qualification standards (one for state
licensure, certification, or registration; and one for compliance with
the Federal CoPs).
This regulatory approach has created unintentional burden during
the hiring process for all of the non HHA-based hospices, as well as
those HHA-based hospices that do not share staff with the home health
agency portion of their organization. The unintentional burden is the
result of hospices having to verify during the aide hiring process that
the applicant meets both the state licensure, certification, or
registration requirements, and also meets the specific training and
competency requirements set forth in the CoPs. State requirements may
change at any time and hospices may receive employment applications
from aides that have been trained in another setting such as nurse aide
training in the long term care environment or private duty aide
training not subject to Federal regulations, so hospices are burdened
with the need to review, in detail, each employment applicant's
training and competency content and format each time they need to make
a new hire. For example, State requirements may specify a different
number of training hours to be completed, a different format for
assessing competency in a specific skill, or even a different set of
mandatory skills in accordance with State scope of practice
requirements. We believe that this is an unnecessary and inefficient
use of hospice staff time that does not serve to improve patient care
and safety.
To address these concerns, we propose to revise Sec.
418.76(a)(1)(iv) to remove the requirement that a State licensure
program must meet the specific training and competency requirements set
forth in Sec. 418.76(b) and

[[Page 47696]]

(c) in order to be deemed an appropriate qualification for employment.
This change would defer to State licensure requirements, except in
states where no requirements exist, regardless of their content or
format, and would allow states to set forth training and competency
requirements that meet the needs of their populations. We do not
believe that it is necessary for the Federal government to oversee the
qualifications established by states because these states have already
demonstrated their willingness and ability to regulate this area along
with federally established requirements. This change would also
streamline the hiring process for most hospices. We would continue to
require that hospice aides may only perform those skills that are
consistent with the training that the aide has received (Sec.
418.76(g)(2)(iv)), and would continue to require that, if an area of
concern is verified by the hospice during an on-site aide supervision
visit, then the hospice must conduct, and the hospice aide must
complete, a competency evaluation in accordance with Sec. 418.76(c)
and (h)(1)(iii). We believe that these requirements will ensure that
aides only perform duties for which they are trained and that they
perform such duties in a safe and effective manner. Furthermore, we
would continue to require that hospices must comprehensively assess
patients on a regular schedule and on an as needed basis (Sec.
418.54(a), (b) and (d)), assure that each patient's plan of care is
developed and continually updated to meet each patient's needs as
identified in the assessment process (Sec. 418.56(b) through (d)),
assure that the plan of care reflects patient and family goals (Sec.
418.56(b) and includes all services (including aide services) necessary
to manage pain and symptoms (Sec. 418.56(c)), and ensure that hospice
care and services are provided in accordance with the plan of care and
are based on all assessments of the patient and family needs (Sec.
418.56(e)). Furthermore, hospices would continue to be required to
provide hospice care that optimizes comfort and dignity, and is
consistent with patient and family needs and goals (Sec. 418.100(a)).
Finally, hospices would continue to be required to maintain an
effective, ongoing, hospice-wide data-driven quality assessment and
performance improvement program that involves all hospice services,
including aide services, that focuses on indicators related to improved
patient outcomes, and takes actions to demonstrate improvement in
hospice performance (Sec. 418.58). While deferring to state
requirements for hospice aide qualifications would likely introduce a
new level of variability in the aide hiring process, we believe that
the remaining hospice CoPs would continue to assure that hospice aide
services meet the needs of patients and families, and are delivered in
a safe and effective manner.
2. Drugs and Biologicals, Medical Supplies, and Durable Medical
Equipment (Sec. 418.106(a)(1) and (e)(2)(i))
The June 5, 2008 Hospice CoP final rule (73 FR 32088) required
hospices to ensure that the interdisciplinary group confers with an
individual with education and training in drug management as defined in
hospice policies and procedures and State law, who is an employee of or
under contract with the hospice to ensure that drugs and biologicals
meet each patient's needs (Sec. 418.106(a)(1)). This requirement was
implemented as a direct result of public comments that were submitted
in regards to the May 2005 Hospice CoP proposed rule (70 FR 30840). The
May 2005 Hospice CoP proposed rule proposed to retain longstanding
requirements for pharmacist involvement in the planning and delivery of
drugs and biologicals for patients that receive care in the hospice
inpatient setting. Commenters suggested that we broaden our proposal
and apply it to patients receiving care in all settings. The commenters
stated that, since drugs are prescribed to virtually all hospice
patients, these patients should benefit from the expertise of a
pharmacist and the additional level of drug oversight required by the
regulatory standards. We agreed with the commenters that it would be
beneficial to patients to broaden the scope of the pharmacy
requirements. For this reason, we finalized a requirement at paragraph
(a), ``Managing drugs and biologicals,'' to require that each hospice
ensures that the interdisciplinary group confers with an individual
with education and training in drug management as defined in hospice
policies and procedures and State law, who is an employee of or under
contract with the hospice to ensure that drugs and biologicals meet
each patient's needs. Hospices have the option of using a licensed
pharmacist or an individual who has an extensive and up-to-date
knowledge of drugs, to fulfill this role.
At the time when this requirement was finalized in 2008, we
estimated that 1,600 hospices (56 percent of all hospices) were already
contracting with pharmacy benefit management companies to provide drugs
and pharmacist services to each of their patients at a single bundled
service rate. These hospices were already realizing the benefits of
specialized drug management expertise in the absence of Federal
regulations. Since 2008, the use of pharmacy benefit management
companies, including their built-in pharmacy experts, has continued to
grow at a rapid pace. Although there have been no formal studies on the
proliferation of pharmacy benefit management company use in hospice,
conversations with industry experts lead us to estimate that, at
minimum, 75 percent of existing hospices use such services. Experts
estimate that the more likely number is between 90 and 95 percent of
hospices due to various factors that hospices find to be desirable,
such as predictable capitated medication fees and direct to the patient
door medication delivery services. Since the use of pharmacology
experts has become routine due to the proliferation of pharmacy benefit
management companies that provide pharmacist services for each patient
bundled with drug and biologics supply services, we believe that it is
no longer necessary to include a regulatory requirement specifically
related to the use of a pharmacology expert. As pharmacy benefit
management services bundle drug and biologics supply services with
expert advice, and since industry experts estimate that at least 75
percent and as many as 95 percent of hospices use pharmacy benefit
management services for reasons primarily unrelated to this specific
regulatory requirement, we conclude that the vast majority of hospices,
and thus the vast majority of hospice patients, will continue to
receive such advice and guidance in the absence of regulation. This
proposed change would allow hospices to more seamlessly integrate the
information provided by the drug management expert into routine
interdisciplinary group meetings rather than having to use burdensome
formulaic approaches that hospices currently implement in order to
demonstrate compliance with the regulation.
In addition to changes in the pharmacy benefit management
landscape, there have also been significant changes in the hospice and
palliative care nursing and physician landscapes. Since publication of
the 2008 Hospice CoP final rule (73 FR 32088), the number of hospice
and palliative care nursing and physician specialty training and
certification programs has rapidly expanded. As more hospice and
palliative care

[[Page 47697]]

nursing and physician specialists have entered the job market, more
hospices are employing these clinicians with advanced skill sets. In
hospices that do not use a pharmacy benefit management service, these
clinicians typically fill the role of the required individual with
education and training in drug management in addition to being the
regular physician or nurse member of the interdisciplinary group. As
these clinicians are already members of the core interdisciplinary
group in accordance with the requirements at Sec. 418.56(a), we
believe that hospices will continue to benefit from their expertise in
the absence of Federal regulations. For these reasons, we conclude that
the requirements at Sec. 418.106(a)(1) are no longer necessary to
assure patient safety and the effectiveness of hospice care.
Furthermore, we believe that hospices may achieve a cost savings upon
removal of this requirement because they will no longer need to assure
a dedicated time in each interdisciplinary group meeting in order to be
able to document that a specific conversation occurred among group
members, and thus document compliance with the regulation. Therefore,
we propose to delete the requirements at Sec. 418.106(a)(1).
Hospices would continue to be required to comprehensively assess
patients on a regular schedule and on an as needed basis (Sec.
418.54(a), (b) and (d)), and to assure that each patient's plan of care
is developed and continually updated to meet each patient's needs as
identified in the assessment process (Sec. 418.56(b) through (d)). To
the extent that a hospice needs additional expert information or
expertise beyond what is provided by hospice employees and the pharmacy
expertise of any pharmacy benefit manager that a hospice may choose to
use in order to meet a given patient's assessment, care planning, and
care delivery medication-related needs, we would continue to require
that it secure such information and expertise. Meeting each patient's
needs would continue to be the responsibility of all Medicare-
participating hospices in accordance with the requirements of all other
hospice CoPs.
The 2008 Hospice CoP final rule (73 FR 32088) also required
hospices, at Sec. 418.106(e)(2)), to: (1) Provide a copy of the
hospice written policies and procedures on the management and disposal
of controlled drugs to the patient or patient representative and
family; (2) discuss the hospice policies and procedures for managing
the safe use and disposal of controlled drugs with the patient or
representative and the family in a language and manner that they
understand to ensure that these parties are educated regarding the safe
use and disposal of controlled drugs; and (3) document in the patient's
clinical record that the written policies and procedures for managing
controlled drugs was provided and discussed. We believe that the
hospice, as well as the patient, family, and caregivers share the
responsibility and accountability for maintaining controlled substances
in the home. We believe that hospices must assume responsibility to
educate the patient and family about the proper use and disposal of
controlled drugs and biologicals that are maintained in the home
environment. The drug policies and procedures also help the hospice
explain its own role in controlled drug management.
We believe that this requirement continues to be relevant,
particularly in relationship to implementing proper storage and
security precautions that can prevent theft and other drug diversion in
the home, and proper disposal when a drug is no longer needed to
prevent inappropriate access and environmental damage. Therefore, we
continue to expect that hospices would have such policies and
procedures for their own internal use as part of routine business
practice. However, hospice policies and procedures are typically
written in ways that are not easily understood by the general public.
Hospice clinicians spend more time than expected explaining technical
terms and otherwise translating the policies and procedures into
layperson's terms. We do not believe that this process of explaining
complex documents in a manner that is meaningful to patients and
families is beneficial to patients, families, caregivers, or hospices.
We propose to replace the requirement that hospices provide a
physical paper copy of policies and procedures, which are written to
guide the actions of hospice staff, with a requirement that hospices
provide information regarding the use, storage, and disposal of
controlled drugs to the patient or patient representative, and family,
which can be developed in a manner that speaks to the perspectives and
information needs of patients and families. This information would be
provided in a more user-friendly manner, as decided by each hospice,
which we believe can improve comprehension and maximize the
effectiveness of the education effort. Furthermore, by providing
information in a more user-friendly manner, hospices would be able to
eliminate time spent explaining technical terms and other otherwise
translating the policies and procedures into layperson's terms. This
would create more efficiency while simultaneously improving hospice-
patient communications. Hospices would be free to choose the content
and format(s) that best suits their needs and the needs of their
patient population. We propose to require that, regardless of the
format chosen, this information must be provided to patients and
families in a manner that allows for continual access to the
information on an as-needed basis in order to assure that patients and
families have information available when they need it. CMS is
soliciting input concerning what a standardized educational format
should entail, including whether the format should be paper or
electronic; in writing, pictorial, video, or audio; what general
subjects should be addressed in regards to storage, disposal, use, and
risks; and what specific content should be included to minimize opioid
diversion and maximize safety.
We would continue to require that hospices discuss the information
regarding the safe use, storage and disposal of controlled drugs with
the patient or representative, and the family, in a language and manner
that they understand to ensure that these parties are effectively
educated. This requirement is included in the current hospice CoPs and
is consistent with Department of Health and Human Services guidance
regarding Title VI of the Civil Rights Act (``Guidance to Federal
Assistance Recipients Regarding Title VI Prohibition Against National
Origin Discrimination Affecting Limited English Proficient Persons,''
68 FR 47311, August 8, 2003, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-Federal-financial-assistance-recipients-title-VI/). We continue to
expect hospices to utilize technology, such as telephonic interpreting
services and any other available resources for oral communication in
the individual's primary or preferred language. We would also continue
to require that hospices document in the patient's clinical record that
the information was provided and discussed.
3. Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/
IID (Sec. 418.112 (c)(10) and (f))
Section 418.112(f) of the hospice CoPs, as finalized in the 2008
Hospice CoP final rule (73 FR 32088), requires hospices to assure
orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or
ICF/IID staff furnishing care to

[[Page 47698]]

hospice patients. This orientation is required to include information
concerning the hospice philosophy, including hospice policies and
procedures regarding methods of comfort, pain control, symptom
management, as well as principles about death and dying, individual
responses to death, patient rights, appropriate forms, and record
keeping requirements. The intent of this standard is to ensure that
facility staff who furnish care to residents who are hospice patients
are provided information on the hospice philosophy and approach to
care, much in the same way that home caregivers are routinely provided
information on the hospice philosophy and approach to care. It is the
hospice's responsibility to coordinate the trainings with
representatives of the facility. It is also the hospice's
responsibility to determine how frequently training needs to be offered
in order to ensure that the staff furnishing care to hospice patients
are oriented to the philosophy of hospice care.
We believe that the intent of the requirement to educate facility
staff about hospice care continues to be an appropriate regulatory
requirement. However, we believe that, as currently written and
implemented, this requirement may create duplication when multiple
hospices provide care to the residents of a single facility.
Furthermore, by assigning sole responsibility for this effort to
hospice providers, this requirement may impede joint hospice-facility
collaboration and training innovations. Creating duplicative efforts
and impeding collaboration may increase hospice burden without
improving the care of hospice patients. Therefore, we believe that it
is appropriate to revise the current requirement.
Specifically, we propose to remove Sec. 418.112(f) and add a new
requirement at Sec. 418.112(c)(10), ``Written agreement,'' to address
this issue. Moving the requirement for facility staff orientation to
the standard related to the written agreement established between
hospices and facilities would ensure that both entities negotiate the
mechanism and schedule for assuring orientation of facility staff.
Additionally, enabling hospices and facilities to negotiate their now
shared role would encourage collaboration between both entities, avoid
duplication of efforts with other hospices that are orienting the same
facility staff, and provide incentives to facilities to become more
engaged in the hospice orientation process for facility staff.
We are seeking public comment on all of the proposed hospice
changes. In addition, we note that we seek to reduce burdens for health
care providers and patients, improve the quality of care, decrease
costs, and ensure that patients and their providers and physicians are
making the best health care choices possible. Therefore, we are
soliciting public comments on additional regulatory reforms for burden
reduction in future rulemaking. Specifically, we are seeking public
comment on additional proposals or modifications to the proposals set
forth in this rule that would further reduce burden on hospices and
create cost savings, while also preserving quality of care and patient
health and safety. Consistent with our ``Patients Over Paperwork''
Initiative, we are particularly interested in any suggestions to
improve existing requirements, within our statutory authority, where
they make providing quality care difficult or less effective. We also
note that such suggestions could include or expand upon comments
submitted in response to the RFI that was included in the FY 2018
Hospice Wage Index and Payment Rate Update and Hospice Quality
Reporting Requirements. Public comments in response to this RFI can be
found at the following link: https://www.regulations.gov/document?D=CMS-2017-0062-0001. Public comments on the RFI can be found
by searching for the terms ``RFI'' or ``request for information'' in
the aforementioned 2017 payment regulation docket on
www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: Danielle Shearer, 410-786-6617.

D. Hospitals

1. Quality Assessment and Performance Improvement Program (Sec.
482.21)
On May 16, 2012, we published a final rule, entitled ``Reform of
Hospital and Critical Access Hospital Conditions of Participation'' (77
FR 29034). In that rule, we finalized changes to the requirements of
the ``Governing body'' CoP, Sec. 482.12, and adopted a policy to allow
one governing body to oversee multiple hospitals in a multi-hospital
system. We noted in this rule that the regulations, as finalized, were
intended to provide systems that own two or more hospitals with an
option, but not a requirement, to use a system governing body for two
or more hospitals. In those instances where a system believes that its
interests are best served by using a system governing body legally
responsible for two or more hospitals, under the CMS regulations, that
system will have the flexibility to do so, just as system that owns two
or more hospitals will have the flexibility to continue with the model
of a separate governing body for each hospital in its system if it
determines that course would best serve its interests.
After publication of the May 2012 final rule, we received a
considerable amount of feedback regarding our responses in the rule (77
FR 29061) where we discussed our interpretation of the Medical staff
CoP at Sec. 482.22 as requiring that each hospital have its own
independent medical staff despite the arguable ambiguity of the
regulatory language. It was brought to our attention that, over the
years, this apparently ambiguous language might have led some
stakeholders to interpret Sec. 482.22 as allowing for separately
certified hospitals, as members of a multi-hospital system, to share a
unified and integrated medical staff. This eventually led to us
proposing a requirement in a February 7, 2013 proposed rule, entitled
``Regulatory Provisions To Promote Program Efficiency, Transparency,
and Burden Reduction--Part II'' (78 FR 9216), which proposed to
prohibit the use of a unified and integrated medical staff subject to a
system governing body.
In the May 12, 2014 final rule, Medicare and Medicaid Programs;
Regulatory Provisions To Promote Program Efficiency, Transparency, and
Burden Reduction (79 FR 27105) that followed, and after carefully
considering all of the arguments for and against allowing a system that
owns two or more hospitals to use a unified and integrated medical
staff structure for its member hospitals that are subject to a common
system governing body, we came to the conclusion that it was in the
best interest of hospitals, medical staff members, and patients for us
to modify the proposed prohibition on the use of a unified and
integrated medical staff for a multi-hospital system and its member
hospitals so as to enable the medical staff of each hospital that is
subject to a common system governing body to voluntarily integrate
itself into a larger system medical staff.
The fact that many hospital systems had been using a unified
medical staff model for a number of years, without evidence showing
that such a model was detrimental to patients or decreased the quality
of care delivered, was a major factor in our decision to allow
hospitals and their respective medical staffs the flexibility to decide
which medical staff framework worked best for

[[Page 47699]]

their particular situations. We received a large number of comments
from individual physicians as well as national and State physician
organizations that supported our proposed changes to reaffirm and make
more explicit the requirement that each hospital to have its own
medical staff, specifically those hospitals that are part of a multi-
hospital system. These commenters stated they believe that allowing a
multi-hospital system to have a unified and integrated medical staff
instead of separate medical staffs for each hospital would destroy the
concept of medical staff self-governance that is ``a basic
requirement'' for TJC hospital accreditation and which is ``mandated by
some states.'' Additionally, there were some comments from individuals
as well as hospital leaders that stated that while they support the
proposed requirement overall, they believe that there should be some
allowance for hospitals within a system to share medical staff bylaws,
rules, and regulations.
However, these arguments against allowing this flexibility through
the CoPs did not provide any evidence that having a single and separate
medical staff for each hospital within a system was inherently
superior, particularly in the areas of patient safety and quality of
care, to the unified and integrated medical staff model for two or more
hospitals subject to a system governing body. We weighed this argument
against the comments from the physician leaders and members of unified
and integrated medical staffs who provided testimony and anecdotal
evidence for the benefits of this type of structure. Additionally, we
considered preliminary evidence that appeared to show that hospitals
using a unified medical staff might be achieving some success in
reducing Hospital-Acquired Conditions (HACs), Healthcare-Associated
Infections (HAIs), and readmissions, and in improving patient safety
and outcomes. During our preliminary development of this rule, we
carefully considered any additional areas where we could provide
further flexibility and reduce regulatory burden for hospitals. We were
particularly interested in those areas that we had not considered or
proposed in the previous rulemaking efforts discussed. As we noted with
regard to the use of a unified medical staff model under a system
governing body, much of the evidence and testimony provided to us at
that time focused on observed improvements in patient safety, quality
of care, and overall patient outcomes. In the May 2014 final rule
previously referenced, one public commenter, writing on behalf of a
multi-hospital system that the commenter references as the largest in
their State, stated that ``we believe the concept of a single medical
staff has substantially contributed to our success as an integrated
delivery system and has accelerated our quality, safety and efficiency
performance.'' The commenter also cited the system's achievements,
which the commenter stated that they believe were a result of this
single and integrated medical staff model: Core measures in the top
quartile with excellent value-based purchasing scores according to CMS;
lower in-hospital mortality rates that are statistically significant,
that is, 17 percent lower than expected; lower hospital readmission
rates that are statistically significant, that is, 15 percent lower
than expected; and the second lowest congestive heart failure
readmission rate in the nation, according to published CMS data.
Since those rules were published, we have not received any negative
feedback on the regulatory changes or any evidence that the use of a
unified medical staff model is detrimental to patients and their care.
And because the potential benefits to using such a system appear to
point to patient safety and quality of care specifically, we began to
look at two areas in the CoPs for possible revision along these lines,
two areas that we believe have the most direct impact on ensuring and
promoting a culture of safety in hospitals--QAPI and infection control.
We believe that applying the unified model to a hospital's QAPI program
and/or a hospital's infection control program would be a natural
progression for a multi-hospital system currently using a system
governing body and a unified medical staff. By allowing a system
governing body the option of unifying and integrating its various
member hospital QAPI programs and/or infection control programs into
unified programs incorporating each individual hospital's QAPI program
and/or infection control program (and thus applying the greater
resources of the system to each hospital's QAPI program and/or
infection control program), we believe a system might be able to more
efficiently and effectively disseminate innovations, solutions, and
best practices for patient care to each of its member hospitals through
these respective unified programs. The Health Research and Educational
Trust, in partnership with the American Hospital Association in a March
2010 publication entitled, ``A Guide to Achieving High Performance in
Multi-Hospital Health Systems,'' identified specific best practices
associated with health systems (http://www.hpoe.org/Reports-HPOE/highperformance3.2010.pdf). The publication stated that ``due to the
size and breadth of their organizations, multi-hospital health system
leaders have significant impact on the quality of health care in the
United States. More than half of all U.S. hospitals belong to multi-
hospital health systems, and about 60 percent of all hospital
admissions occurs in system hospitals. While a wide range of quality
improvement mechanisms can be applied in individual hospitals, there
has been a lack of actionable information that leaders of multi-
hospital systems can leverage to improve quality across their
systems.''
Therefore, we propose to apply this same level of flexibility and
regulatory burden reduction to a hospital's QAPI program as an option
for system governing bodies that directly control and are legally
responsible for two or more separately certified hospitals. As with our
allowances for system governing bodies and unified medical staffs noted
previously, we believe that system governing bodies that are legally
responsible for two or more separately certified hospitals should be
given the flexibility to determine which model of a QAPI program works
best for their individual member and separately certified hospitals. We
also believe that, in addition to the efficiencies that might be gained
in the management and administration of QAPI programs through the
increased resources of the hospital system, there might also be
significant improvements in patient safety and outcomes to be achieved
through such resources. Allowing for a unified and integrated QAPI
program for its member hospitals would provide a system governing body
with the needed flexibility and ease of administration to more readily
apply the best practices and innovations learned and developed at one
hospital to other hospitals subject to the same system governing body
that might be facing the same problem-prone areas of patient care. We
believe that by allowing system governing bodies this regulatory
option, greater communication between member hospitals would be
fostered so that a culture of patient safety and quality care could
then be more fully integrated throughout the system. Given this
flexibility and opportunity for integration, we believe that member
hospitals subject to the same system governing body would replace the
approach of each hospital operating within its own ``silo,'' a still
all-too-

[[Page 47700]]

common operating standard, even within multi-hospital systems, that
thwarts advances and innovations in improving patient care across the
system.
We propose a new standard at Sec. 482.21(f), ``Unified and
integrated QAPI program for multi-hospital systems''. We would allow
that for a hospital that is part of a hospital system consisting of two
or more separately certified hospitals subject to a system governing
body legally responsible for the conduct of each hospital, the system
governing body could elect to have a unified and integrated QAPI
program for all of its member hospitals after determining that such a
decision is in accordance with all applicable State and local laws. The
system governing body would be responsible and accountable for ensuring
that each of its separately certified hospitals meets all of the
requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that:
The unified and integrated QAPI program was established in a manner
that took into account each member hospital's unique circumstances and
any significant differences in patient populations and services offered
in each hospital; and the unified and integrated QAPI program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration, and
that the unified and integrated QAPI program has mechanisms in place to
ensure that issues localized to particular hospitals are duly
considered and addressed. Our expectation is that the focus on quality
assessment, performance improvement, and patient safety within a
certified hospital that is part of a unified and integrated QAPI
program would be maintained and enhanced through the benefits of such
integration.
2. Medical Staff, Medical Records Services, and Surgical Services
(Sec. Sec. 482.22, 482.24, and 482.51)
Hospital Medical History and Physical Examination Requirements
The current CoP at Sec. 482.22, ``Medical Staff,'' requires that a
hospital have an organized medical staff that operates under bylaws
approved by the governing body, and which is responsible for the
quality of medical care provided to patients by the hospital. At Sec.
482.22(c)(5), the hospital medical staff bylaws must include a
requirement that a H&P be completed and documented for each patient no
more than 30 days before or 24 hours after admission or registration,
but prior to surgery or a procedure requiring anesthesia services. The
bylaws must also include a requirement that an updated examination of
the patient, including any changes in the patient's condition, be
completed and documented within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services, when the H&P are completed within 30 days before admission or
registration. These medical staff bylaws requirements addressing
patient H&Ps form the basis for similar requirements in the hospital
CoPs at Sec. 482.24, ``Medical Record Services,'' and Sec. 482.51,
``Surgical Services.''
Current hospital H&P requirements were proposed and finalized
between 2005 and 2007, and similar ASC requirements were finalized 1
year later. According to a February 28, 2017, Centers for Disease
Control and Prevention (CDC) National Health Statistics Report (Hall
MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from
hospitals and ambulatory surgery centers: United States, 2010. National
health statistics reports; no. 102. Hyattsville, MD: National Center
for Health Statistics. 2017), in 2010, 28.6 million ambulatory surgery
visits to hospitals and ASCs occurred, with an estimated 48.3 million
surgical and nonsurgical procedures performed. The report also states
that an estimated 25.7 million (53 percent) ambulatory surgery
procedures were performed in hospitals and 22.5 million (47 percent)
were performed in ASCs during this time. Further, the report found that
the most frequently performed procedures (for both ASCs and hospital
outpatient/ambulatory surgery departments) included endoscopy of large
intestine (4.0 million), endoscopy of small intestine (2.2 million),
extraction of lens (2.9 million), insertion of prosthetic lens (2.6
million), and injection of agent into spinal canal (2.9 million). These
statistics, which also show similarities between the characteristics of
patients seen by ASCs and hospital outpatient/ambulatory surgery
departments, combined with the evidence already discussed in section
II.B.2, ``Patient Admission, Assessment and Discharge'' (Sec.
416.52(a)(1), (2), (3) and (4)) have led us to conclude that we should
propose a less burdensome option for the assessment of a patient prior
to a hospital outpatient/ambulatory surgery or procedure for specific
patients and procedures.
Because the hospital H&P requirements apply to all hospital
patients (not just ambulatory surgery patients, as in ASCs) and because
these requirements are contained under three separate CoPs, any
proposed hospital requirements for pre-surgical assessments in lieu of
the current requirements for a comprehensive H&P would need to be
structured somewhat differently than those proposed for ASCs. However,
we are basing certain aspects of the proposed hospital requirements on
those proposed for ASCs in order to take into account some of the
similarities of the two provider types.
We would revise the current requirements at Sec. 482.22(c)(5)(i)
and (ii) with respect to medical staff bylaws to allow for an exception
under the proposed paragraph (c)(5)(iii). We are retaining the current
language in paragraphs (c)(5)(i) and (ii) that the H&P, and any update
to it, must be completed and documented by a physician (as defined in
section 1861(r) of the Act), an oromaxillofacial surgeon, or other
qualified licensed individual in accordance with State law and hospital
policy. We propose to include this same language regarding who can
complete and document the assessment in the proposed provision at Sec.
482.22(c)(5)(iii). This provision would require the medical staff
bylaws to state that an assessment of the patient (in lieu of the
requirements of paragraphs (c)(5)(i) and (ii)) be completed and
documented after registration, but prior to surgery or a procedure
requiring anesthesia services, when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at paragraph (c)(5)(v), specific
patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical
or procedural services. The proposed paragraphs (c)(5)(iii) and (iv)
would require the medical staff to develop and maintain a policy that
identifies those patients for whom the assessment requirements of
paragraph (c)(5)(iii) would apply. We are also proposing a new
requirement at paragraph (c)(5)(v) for a medical staff that chooses to
develop and maintain a policy for the identification of specific
patients to whom the assessment requirements in paragraph (c)(5)(iii)
would apply. Under this proposed paragraph, if the medical staff
exercised the option to perform a simplified assessment in some cases,
the written policy would have to indicate the specific outpatient
surgical or procedural services to which it applied. The policy for
each procedure would

[[Page 47701]]

need to indicate the hospital's consideration of patient age,
diagnoses, the type and number of surgeries and procedures scheduled to
be performed, comorbidities, and the level of anesthesia required for
the surgery or procedure; nationally recognized guidelines and
standards of practice for assessment of specific types of patients
prior to specific outpatient surgeries and procedures; and applicable
State and local health and safety laws.
In order to make clear that this proposed requirement would be an
option that a hospital and its medical staff could elect to use at
their discretion, we propose language that states ``the provisions of
paragraphs (c)(5)(iii), (iv), and (v) do not apply to a medical staff
that chooses to maintain a policy that adheres to the requirements of
paragraphs (c)(5)(i) and (ii) for all patients.'' In other words, a
hospital and its medical staff would be free to exercise their clinical
judgment in determining whether a policy for identifying specific
patients as not requiring a comprehensive H&P (or any update to it)
prior to specific outpatient surgical or procedural services, and
instead requiring only a pre-surgical assessment for these patients,
would be their best course. Or, if a hospital and its medical staff
decided against such a policy, then only the current H&P and update
requirements (at Sec. Sec. 482.22, 482.24, and 482.51) would continue
to apply and the proposed requirements for this CoP, as well as those
proposed for Sec. Sec. 482.24 and 482.51, would not apply.
For the current CoP at Sec. 482.24, ``Medical Record Services,''
we would revise the provisions at Sec. 482.24(c)(4)(i)(A) and (B)
regarding an H&P and its update to allow for an exception under
proposed paragraph (c)(4)(i)(C) where are proposing to add a new
requirement that, if applicable, the medical record would have to
document assessment of the patient (in lieu of the requirements of
paragraphs (c)(4)(i)(A) and (B) after registration, but prior to
surgery or a procedure requiring anesthesia services, for specific
outpatient surgical or procedural services.
The current CoP at Sec. 482.51, ``Surgical Services,'' contains
provisions at Sec. 482.51(b)(1)(i) and (ii) that require, prior to
surgery or a procedure requiring anesthesia services and except in the
case of emergencies that a medical history and physical examination
must be completed and documented no more than 30 days before or 24
hours after admission or registration an updated examination of the
patient, including any changes in the patient's condition, must be
completed and documented within 24 hours after admission or
registration when the medical history and physical examination are
completed within 30 days before admission or registration. We are
revising these requirements to allow for an exception to them under
proposed paragraph (b)(1)(iii), where we propose a new requirement
that, prior to surgery or a procedure requiring anesthesia services and
except in the case of emergencies, an assessment of the patient must be
completed and documented after registration (and in lieu of the
requirements of paragraphs (b)(1)(i) and (ii)). This proposed
requirement would only apply in those instances when the patient is
receiving specific outpatient surgical or procedural services and when
the medical staff has chosen to develop and maintain a policy that
identifies, in accordance with the requirements at Sec.
482.22(c)(5)(v), specific patients as not requiring a comprehensive
medical history and physical examination, or any update to it, prior to
specific outpatient surgical or procedural services.
As we did in the ASC section's discussion of these proposed changes
to the H&P requirements, we request comment on whether there are any
evidence-based exceptions or specific guidelines, such as for
particular patient conditions or surgical procedures, that would
prohibit this level of discretion for determining those hospital
outpatient surgery patients who would not require a comprehensive H&P
prior to outpatient surgeries or procedures.
Contact: CDR Scott Cooper, USPHS, 410-786-9465.
3. Medical Staff: Autopsies (Sec. 482.22(d))
In the June 1986 final rule, Medicare and Medicaid Programs,
Conditions of Participation for Hospitals (51 FR 22010), we finalized a
regulation to recommend that a hospital's medical staff attempt to
secure autopsies in all cases of unusual deaths and of medical-legal
and educational interest. Hospitals are further required to define a
mechanism for documenting permission to perform an autopsy, and they
must have a system for notifying the medical staff, and specifically
the attending practitioner, when an autopsy is being performed. In that
final rule, we stated that autopsies were an essential educational tool
which contributed to the quality of care furnished by a hospital.
Medical-legal investigative autopsies are conducted by a coroner's or
medical examiner's office to determine the circumstances under which
someone died and combine a scientific inquiry into a death under a
coroner's or medical examiner's legal jurisdiction (https://www.cdc.gov/phlp/publications/topic/coroner.html).
Although the regulations specify that hospitals should attempt to
secure permission to perform autopsies in certain cases, each state has
established specific standards, laws, and regulations regarding the
performance of autopsies for medical-legal investigative purposes for
hospital patients. According to CDC's Public Health Law Program, each
State sets its own standards for what kinds of deaths require
investigation and its own professional and continuing education
requirements for individuals carrying out these investigations. For
example, the Medicolegal Death Investigation system for the state of
New York specifies the use of coroners and medical examiners, who have
specific medical and residency qualifications. Maine's Medicolegal
Death Investigation system only specifies the role of a medical
examiner. Unlike the regulations of the individual States, Sec.
482.22(d) does not provide specifics on who should perform an autopsy,
nor does it delve into the specifics of the medical-legal investigation
process. As with all other CoPs, our intention was not to be overly
prescriptive or overly burdensome in our requirements. In this case,
the individual States have more specific requirements than the CoPs.
After reexamining this CoP, and in an effort to reduce duplicative
or redundant requirements for hospitals, we believe that it is
appropriate to remove the requirement at Sec. 482.22(d). We believe
that more detailed, specific requirements regarding medical-legal
investigations and autopsies for hospitals are more appropriately and
more effectively covered by the individual State laws in which the
hospital is located. Therefore, we propose to remove the requirement at
Sec. 482.22(d). However, we continue to believe that the performance
of autopsies further advances medical knowledge.
Contact: Alpha-Banu Wilson, 410-786-8687.
4. Infection Control (Sec. 482.42)
Similar to our proposal for a unified and integrated QAPI program
for multi-hospital systems previously discussed, we believe that the
same level of flexibility and regulatory burden reduction can be
applied to a hospital's infection control program. We firmly believe
that the same efficiency of administration, and improved patient
outcomes, patient safety, and quality of care would be achieved in the
infection control realm through a consistent system-wide approach as
would be

[[Page 47702]]

allowed by this proposed rule. Our expectation is that the focus on
infection control within a certified hospital that is part of a unified
and integrated infection control program would be maintained and
enhanced through the benefits of such integration, and that the
trajectory toward continued reductions in infections would be
continued.
Therefore, we propose a new standard at Sec. 482.42(c), ``Unified
and integrated infection control program for multi-hospital systems.''
Like the proposed requirements for a unified and integrated QAPI
program, the proposed standard for infection control would allow that
for a hospital that is part of a hospital system consisting of multiple
separately certified hospitals subject to a system governing body
legally responsible for the conduct of each hospital, such system
governing body could elect to have a unified and integrated infection
control program for all of its member hospitals after determining that
such a decision was in accordance with all applicable State and local
laws. The system governing body would be responsible and accountable
for ensuring that each of its separately certified hospitals met all of
the requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that the
unified and integrated infection control program: (1) Was established
in a manner that took into account each member hospital's unique
circumstances and any significant differences in patient populations
and services offered in each hospital; (2) established and implemented
policies and procedures to ensure that the needs and concerns of each
of its separately certified hospitals, regardless of practice or
location, are given due consideration; (3) had mechanisms in place to
ensure that issues localized to particular hospitals are duly
considered and addressed; and (4) designated a qualified individual(s)
at the hospital with expertise in infection prevention and control to
be responsible for communicating with the unified infection control
program, for implementing and maintaining the policies and procedures
governing infection control, and for providing infection prevention
education and training to hospital staff.
We are specifically seeking comment on whether there are any other
programs currently required under the CoPs for each separately
certified hospital, beyond the QAPI and Infection control programs
proposed here, that stakeholders believe would likewise be better
managed under a system governing body legally responsible for the
conduct of each separately certified hospital.
Contact: CDR Scott Cooper, USPHS, 410-786-9465.
5. Special Requirements for Hospital Providers of Long-Term Care
Services (``Swing-Beds'') (Sec. 482.58(b)(1), (4), (5), and (8), and
Identical CAH Requirements: Sec. 485.645(d)(1), (4), (5), (6), and
(7))
Section 1883 of the Act permits certain small, rural hospitals to
enter into a swing-bed agreement, under which a hospital or CAH can use
its beds as needed, to provide either acute or SNF care. Swing-beds are
beneficial when a patient is ready to leave the acute care level of a
hospital stay, but still requires further skilled nursing care. They
are often the only option in rural areas to provide this level of care.
As defined in our regulations, a swing-bed hospital is a hospital or
CAH participating in Medicare that has CMS approval to provide post-
hospital SNF care and meets certain requirements. Hospitals providing
swing-bed services must meet all of the requirements at 42 CFR part
482, which includes the swing-bed requirements at Sec. 482.58 for
patients receiving swing-bed services, and CAHs providing swing-bed
services must meet all of the requirements at 42 CFR part 485, subpart
F, which includes the swing-bed requirements at Sec. 485.645 for
patients receiving swing-bed services.
The hospital CoPs at Sec. 482.58(a)(1) and (2) specify that
hospitals providing swing-bed services must be located in a rural area
and have less than 100 beds. Section 482.58(a)(1) excludes from the
count beds for newborns and beds in intensive care type inpatient
units, and Sec. 482.58(a)(2) requires that the hospital be located in
rural area, which includes all areas not delineated as ``urbanized''
areas by the Census Bureau, based on the most recent census.
The CAH CoPs at Sec. 485.645(a)(2) state that a CAH must not
maintain more than 25 inpatient beds that may be used for the provision
of inpatient or swing-bed services, and as required at Sec.
485.635(b)(1)(ii), the CAH must furnish acute care inpatient services
to patients who present to the CAH for treatment, so long as the CAH
has an available inpatient bed and the treatment required to
appropriately care for the patient is within the scope of services
offered by the CAH (State Operations Manual, Appendix W).
Hospitals and CAHs must both meet eligibility requirements to be
granted approval from CMS to provide swing-bed services. The swing-bed
requirements within the hospital and CAH CoPs include a subset of
cross-referenced long-term care requirements contained in 42 CFR part
483, subpart B, for which hospital and CAH swing-bed providers are
surveyed as they are for all of the CoPs in their respective programs.
The long-term care requirements under 42 CFR part 483 frequently
reference residents given the average length of stay in long-term care
facilities (28 days for skilled nursing facilities and 835 days for
nursing homes) (Medicare Skilled Nursing Facility (SNF) Transparency
Data (CY2013), https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-03-09.html#; Centers for Disease
Control and Prevention, Nursing Home Care FastStats, https://www.cdc.gov/nchs/data/series/sr_03/sr03_038.pdf). However, individuals
receiving swing-bed services in a hospital or CAH are receiving SNF
services and generally have shorter length of stays, with an the
average length of stay of 11.4 days (Centers for Medicare & Medicaid
Services, Office of Enterprise Data and Analytics, 2016). Note that
this is still less than the average 28-day length of stay in a SNF.
While we understand that some patients receiving swing-bed services in
a hospital or CAH may have longer than average length of stays, we have
determined that some of the cross-referenced long-term care
requirements for hospitals and CAH swing-bed providers are unnecessary
and unduly burdensome given their focus on ``residents'' and longer
length of stays. Thus, we propose to remove the following requirements:
Sec. Sec. 482.58(b)(1) and (c) and 485.645(d)(1)
(incorporating long-term care facility requirements at Sec.
483.10(f)(9): Under our current regulations at Sec. 483.10(f)(9), the
resident has a right to choose to or refuse to perform services for the
facility, and the facility must not require a resident to perform
services for the facility. Regulations at Sec. Sec. 482.58(b)(1) and
485.645(d)(1) incorporate this resident right by reference. The
resident may perform services for the facility, if he or she chooses.
The current requirement for LTCFs also states that residents of
these providers who are receiving swing-bed services who choose to
perform services for the facility may do so when the facility has
documented the need or desire for the resident to work in the plan of
care; the plan specifies the nature of the services performed and
whether the services are voluntary or paid; compensation for paid
services is

[[Page 47703]]

at or above prevailing rates; and the resident agrees to the work
arrangement described in the plan of care. Provided that those
receiving hospital and CAH swing-bed services are not residents and
spend a limited amount of time receiving swing-bed services, we have
determined that this is an unduly burdensome requirement. Swing-bed
services are transitional SNF-level services provided on a temporary
basis. As a result, only a limited number of the SNF requirements are
applicable to these patients. Therefore, we believe that it is unlikely
that patients receiving hospital and CAH swing-bed services would be
assigned a job and given an opportunity to provide services at the
hospital or CAH due to their relatively short length of stay. With the
proposed removal of this requirement, a hospital or CAH may permit
patients receiving swing-bed services to provide services at the
facility upon mutual agreement between the patient and the facility;
thus, we believe that this requirement is unnecessary. We expect
hospital and CAH swing-bed providers who do offer patients the option
of providing services for the facility to have current policies and
procedures that reflect this policy that includes protocol for
establishing an agreement between the two parties. In addition, in the
absence of these requirements, we believe patients' rights requirements
for hospitals at Sec. 482.13 and CAHs providing swing-bed services at
Sec. 485.645(d)(3) (which incorporates the long-term care requirements
that patients be free from abuse, neglect and exploitation) would
address such situations. We would monitor for any unintended
consequences, as well as through evaluation of complaints that might be
submitted regarding involuntary work performed by patients receiving
swing-bed services in hospitals and CAHs. We would also ensure patient
protections were maintained via the survey process and the process used
to determine allegations of non-compliance with Federal or State
requirements.
Sec. Sec. 482.58(b)(4) and 485.645(d)(4) (incorporating
long-term care facility requirements at Sec. 483.24(c)): The facility
must provide, based on the comprehensive assessment and care plan and
the preferences of each resident, an ongoing program to support
residents in their choice of activities and the activities program must
be directed by a qualified professional who is a qualified therapeutic
recreation specialist or an activities professional.
Similar to the requirements noted previously, we believe that this
requirement is also unnecessary and burdensome for hospitals and CAHs,
as patients receiving swing-bed services in a hospital or CAH are not
long term residents of the facility and generally only receive swing-
bed services for a brief period of time for transition after the
provision of acute care services. We expect that for those patients who
receive swing-bed services for an extended period of time, their
nursing care plan--as required under Sec. 482.23(b)(4) for hospitals
and Sec. 485.635(d)(4) for CAHs--is based on assessing the patient's
nursing care needs and will support care that holistically meets the
needs of the patient, taking into consideration physiological and
psychosocial factors.
Sec. Sec. 482.58(b)(5) and 485.645(d)(5) (incorporating
long-term care facility requirements at Sec. 483.70(p)): Any facility
with more than 120 beds must employ a qualified social worker on a
full-time basis.
We propose to revise the requirements at Sec. Sec. 482.58(b)(5)
and 485.645(d)(5) for hospitals and CAHs. The requirement that hospital
and CAH swing-bed providers with more than 120 beds employ a full-time
social worker is not applicable to either provider type. In accordance
with the hospital and CAH swing-bed requirements, hospital swing-bed
providers are not permitted to have more than 100 beds while CAH swing-
bed providers are not permitted to have more than 25 beds for the
provision of inpatient or swing-bed services. Based on feedback from
stakeholders, removing this requirement would eliminate confusion for
providers and accreditation organizations.
Sec. Sec. 482.58(b)(7) and 485.645(d)(7) (incorporating
the long-term care facility requirement at Sec. 483.55(a)(1)): Under
our long-term care facility requirements, the facility, must provide or
obtain from an outside resource, in accordance with Sec. 483.70(g),
routine and emergency dental services to meet the needs of each
resident. We believe that this requirement is unnecessary and unduly
burdensome for hospital and CAH swing-bed providers, as patients
receiving swing-bed services in a hospitals or CAHs are not ``generally
long term residents'' of the facility and are meant to receive swing-
bed services for a brief period of time for transition after the
provision of acute care services. The American Dental Association
recommends regular dental checkups at least once a year for routine
dental care for adults over 60 years of age. With an average length of
stay in a hospital or CAH swing-bed of 11.4 days and an average daily
swing-bed census of 2 patients, we believe that it is unlikely that
there is a need for routine dental services that cannot be provided on
an outpatient basis. We expect that any required dental services that
necessitate immediate treatment would be considered an emergency and
would be addressed accordingly. In addition, the American Dental
Association recommends that routine dental care be obtained at least
every 6 months, which greatly exceeds that average length of stay in a
hospital or CAH swing-bed. However, hospitals and CAHs are required to
provide care in accordance with the needs of the patient that have been
identified in such patients' plans of care; this could include non-
emergency dental care. We expect that hospital swing-bed providers are
currently addressing the emergent dental care needs of their patients
under the existing hospital CoP at Sec. 482.12(f)(2), which requires
that hospitals have written policies and procedures for appraisal of
emergencies, initial treatment, and referral when appropriate.
Similarly, we expect that CAH swing-bed providers are currently
addressing the emergent dental care needs of their patients under the
existing emergency services CoP at Sec. 485.618, which requires CAHs
to provide emergency care necessary to meet the needs of its inpatients
and outpatients. As a result, we believe that this portion of the
requirement is duplicative, given the current CoP requirements.
Contact: Kianna Banks, 410-786-3498.
6. Special Requirements for Psychiatric Hospitals (Sec. 482.61(d))
Section 482.61(d) of our regulations, as finalized in the June 1986
final rule (51 FR 22050), requires that progress notes be documented by
the doctor of medicine (MD) or doctor of osteopathy (DO) responsible
for the care of the patient and, when appropriate, others significantly
involved in active treatment modalities. ``Others significantly
involved in active treatment modalities'' has been interpreted as staff
from other disciplines, such as rehabilitative therapy and psychology,
which are significantly involved in active treatment modalities and
interventions. The intent of this requirement is to assure that the
patient's medical record contains documentation of the patient's
response to treatment planning and course of treatment. This
documentation also serves to apprise all staff about patient's progress
and any new problems or regression. We believe that the intent of the
requirement to record progress notes in the patient's medical record
continues to be an appropriate regulatory requirement. However, we

[[Page 47704]]

believe that as currently written and implemented, this requirement
requires clarification. We believe that non-physician practitioners,
including physician assistants, nurse practitioners, psychologists, and
clinical nurse specialists, when acting in accordance with State law,
their scope of practice, and hospital policy, should have the authority
to record progress notes of psychiatric patients for whom they are
responsible. Therefore, we propose to allow the use of non-physician
practitioners or MD/DOs to document progress notes of patient receiving
services in psychiatric hospitals.
Contact: Kianna Banks, 410-786-3498.
We are seeking public comment on all of the proposed hospital
changes. In addition, we note that we seek to reduce burdens for health
care providers and patients, improve the quality of care, decrease
costs, and ensure that patients and their providers and physicians are
making the best health care choices possible. Therefore, we are
soliciting public comments on additional regulatory reforms for burden
reduction in future rulemaking. Specifically, we are seeking public
comment on additional proposals or modifications to the proposals set
forth in this rule that would further reduce burden on hospitals and
create cost savings, while also preserving quality of care and patient
health and safety. Consistent with our ``Patients Over Paperwork
Initiative,'' we are particularly interested in any suggestions to
improve existing requirements, within our statutory authority, where
they make providing quality care difficult or less effective. We also
note that such suggestions could include or expand upon comments
submitted in response to RFIs that were included in the following 2017
prospective payment regulations for hospitals:
FY 2018 Hospital Inpatient Prospective Payment System for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System found at https://www.regulations.gov/docket?D=CMS-2017-0055.
CY 2018 Outpatient Prospective Payment System/Ambulatory
Surgical Center proposed rule (https://www.regulations.gov/docket?D=CMS-2017-0091).
FY 2018 Inpatient Rehabilitation Facility Prospective
Payment System (https://www.regulations.gov/document?D=CMS-2017-0059-0002).
FY 2018 Inpatient Psychiatric Facilities Prospective
Payment System (https://www.regulations.gov/document?D=CMS-2018-0053-0002).
Public comments on the RFIs can be found by searching for the terms
``RFI'' or ``request for information'' in the aforementioned 2017
payment regulation dockets on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.

E. Transplant Centers

Transplant programs, located within a transplant hospital that has
a Medicare provider agreement, provide transplantation services for a
particular organ type. Transplant programs must comply with the
transplant center CoPs, located at Sec. Sec. 482.72 through 482.104,
and with the hospital CoPs. There are several types of transplant
programs including heart, lung, liver, and kidney. Intestine, pancreas,
and multi-organ transplants are performed within existing transplant
programs. For the purposes of this discussion, we define a transplant
center as a group of transplant programs that are located in a
transplant hospital. A transplant program is a component of the
transplant center, within a transplant hospital, that provides
transplantation for a particular type of organ. Transplant programs are
surveyed for compliance with the CoPs.
This proposed rule uses the term ``transplant center'' when
discussing the current requirements and language used in the
regulations. In accordance with our proposed nomenclature change,
discussed later in this proposed rule, the term ``transplant program''
is widely used throughout the preamble and in the proposed regulation
text.
Section 1881(b)(1) of the Act sets out our authority for the
Secretary to prescribe regulations for facilities furnishing end stage
renal disease care to beneficiaries, including renal transplant
centers. Section 1861(e)(9) of the Act permits the Secretary to issue
regulations for the health and safety of individuals furnished services
in hospitals.
In response to the relative scarcity of donated organs compared to
the number of people on transplant waitlists and the critical need to
use these limited resources efficiently, we published a final rule that
established CoPs for transplant centers on March 30, 2007, (Medicare
Program; Hospital Conditions of Participation: Requirements for
Approval and Re-Approval of Transplant Centers To Perform Organ
Transplants) which codified requirements for approval and re-approval
of transplant centers. We also placed Medicare-approved transplant
centers under the survey and certification enforcement process we use
for all other providers and suppliers of Medicare items and services
(72 FR 15198). The transplant center CoPs include data submission,
clinical experience, outcome, and process requirements for approval and
re-approval of transplant centers. The requirements focus on an organ
transplant program's ability to perform successful transplants and
deliver quality patient care, as evidenced by outcomes as well as sound
policies and procedures. The CoPs include requirements to protect the
health and safety of both transplant recipients and living donors.
We have continued to review and analyze the effectiveness of the
transplant center CoPs, the effects of interpretive guidance, and the
data derived from surveys of transplant programs. We also received
comments from various stakeholders within the transplant center
community that detailed the impacts of the implementation of the CoPs
on transplant programs and transplant recipients. Upon further review,
and taking into account input from various stakeholders, we believe
that it is appropriate and necessary to revise the transplant center
CoPs in order to reduce provider burden, increase long-term savings to
the Medicare program, and eliminate obsolete or unnecessary
requirements, while also continuing to protect the health and safety of
transplant recipients and living donors.
Furthermore, we believe that revising the transplant center CoPs
will positively impact organ donation and transplantation in the United
States by increasing the number of transplants performed each year and
increasing the organ utilization rate, for reasons we discuss in
further detail below. According to the Organ Procurement and
Transplantation Network (OPTN) 33,610, organ transplants were performed
and 15,948 donors (both living and deceased) provided organs in the
United States in 2016. However, as of the writing of this proposed
rule, 117,104 people still need a lifesaving organ transplant in 2017
(number represents total waiting list candidates, https://optn.transplant.hrsa.gov/, July 2017). While strides are being made to
improve organ donation and increase the number of organ transplants in
the United States, there continues to be a shortage of organs.
Therefore, we propose to revise the transplant center CoPs, as
follows:

[[Page 47705]]

1. Special Requirement for Transplant Centers (Sec. Sec. 482.68 and
482.70)
Section 482.68 generally describes the requirements that a
transplant center must meet in order to participate in the Medicare
program; section Sec. 482.70 sets out definitions of terms used in the
regulations. Specifically, in addition to meeting all the CoPs as a
hospital, a transplant center must meet the CoPs specified in
Sec. Sec. 482.72 through 482.104 in order to be granted approval from
CMS to provide transplant services. Throughout the regulation, we use
terminology relevant to transplantation and organ procurement to
describe transplant centers, programs, living donors, and transplant
center recipients. Because the terminology currently used in the
regulation is not consistent with current nomenclature used throughout
the transplant community and by the OPTN, Scientific Registry of
Transplant Recipients (SRTR), and the Department of Health and Human
Services (HHS), we propose to update the terminology within the
hospital regulation at part 482 and the transplant regulations at
Sec. Sec. 482.68, 482.70, 482.72 through 482.104, and at Sec. 488.61,
for clarification and consistency. Specifically, we propose a
nomenclature change which would:
Replace the term transplant ``center'' in the regulation
language with transplant ``program'' (each organ type would be a
transplant program). A transplant program is located within a
transplant hospital that provides transplantation services for a
particular type of organ. Since individual transplant programs are
surveyed for compliance with the CoPs, using the term transplant
program throughout the regulation better aligns with current surveyor
practice and will reduce provider confusion. In order to provide
further clarity, we are also proposing to update the definitions at
Sec. 482.70.
Consistently use Independent Living Donor Advocate (ILDA)
throughout the regulation.
Change ``beneficiaries'' to ``recipients''.
Since these changes would make our terms consistent with the
terminology utilized by the OPTN and the transplant community, we
believe these proposed changes would reduce provider confusion.
2. Data Submission, Clinical Experience, and Outcome Requirements for
Re-Approval of Transplant Centers (Sec. 482.82)
Section 482.82 requires that transplant centers that are applying
for Medicare re-approval meet all data submission, clinical experience,
and outcome requirements in order to be re-approved. In the March 2007
final rule (72 FR 15198), we also finalized these requirements for
initial Medicare approval of transplant centers, as described in Sec.
482.80. Since the publication of the final rule, several studies have
been published that examine the impact of these requirements on
transplantation and organ utilization in the United States. A 2016
article published in the American Medical Association Journal of Ethics
concluded that ``using measured outcomes for punitive purposes may have
resulted in significant unintended consequences'' and that ``transplant
professionals will, by necessity, adapt practice to minimize the risk
of regulatory citation and loss of transplant volume'' which
contributes to ``lower transplant rates (typically among higher-risk
candidates)'' and increased organ discard of marginal organs. (Adler,
Joel T. and Axelrod, David A. Regulations' Impact on Donor and
Recipient Selection for Liver Transplantation: How Should Outcomes be
Measured and MELD Exception Scores be Considered, AMA Journal of
Ethics, Vol. Volume 18, Number 2: 133-142. Doi: 10.1001/
journalofethics.2016.18.02. pfor1-1602, February 2016.).
Another study linked performance evaluations to transplant volume
in kidney transplant centers. The authors observed that centers that
had low performance evaluations were more likely to have fewer kidney
transplants than other kidney transplant centers. The study stated that
kidney transplant centers that were identified with poor outcomes ``may
be more likely to have staff turnover which may lead to declines in
transplant volume'' and ``[c]enters that have been evaluated with lower
performance may generally become more conservative in overall
acceptance rates of candidates and donor organs'' (Schold, JD, et al.
The Association of Center Performance Evaluations and Kidney Transplant
Volume in the United States. American Journal of Transplantation 2013;
13: 67-75. doi: 10.1111/j.1600-6143.2012.04345, 2013.).
Another study covering over 90,000 liver transplant candidates
concluded that the transplant center regulations that were finalized in
the March 2007 final rule (72 FR 15198) increased the likelihood that
liver transplant candidates would be removed from the liver transplant
candidate waitlist and that this policy change led to the sickest
patients being increasingly ``denied this lifesaving procedure while
transplant mortality risks remain unaffected.'' The study found that
the 2007 regulations had the effect of altering waitlist management and
clinical decision making, thereby increasing the removal of the sickest
patients from the waitlist. The impacts were seen through a 16 percent
increase in delisting of patients due to the severity of their illness
after the implementation of the 2007 regulation, and likelihood of
being delisted continued to increase thereafter. The authors concluded
that the 2007 regulation, which aimed to improve patient outcomes, had
the consequence of instead failing to show any benefit to liver
transplant patients. The authors suggested that future national policy
decisions consider rebalance of the waitlist and transplant outcomes
scale (Dolgin, Natasha H. et al. Decade-Long Trends in Liver Transplant
Waitlist Removal Due to Illness Severity: The Impact of Centers for
Medicare and Medicaid Services Policy. Journal of the American College
of Surgeons. Volume 222, Issue 6, Pages 1054-1065. DOI: http://dx.doi.org/10.1016/j.jamcollsurg.2016.03.021, June 2016.).
Another study of kidney transplantation found that most of the
increases in the discard rate from 1988 to 2009 could be explained by
recovery of organs from an increasing donor pool and changes in
``pumping'' or perfusion practices. ``However, the presence of an
unexplained, residual increase suggests behavioral factors (e.g.,
increased risk aversion) . . . may have played a role.'' (Darren E.
Stewart, et al. Diagnosing the Decades-Long Rise in the Deceased Donor
Kidney Discard Rate in the United States. Transplantation. 2017; 101:
575-587.).
A different approach was taken in a recent study using data from
2000 to 2015. This study found that by comparing donors from whom one
only one kidney was discarded and the other was transplanted reasons
for discard could be better assessed. In this study ``a large number of
discarded kidneys were procured from donors whose contralateral kidneys
were transplanted with good post-transplant outcomes.'' It found that
when two kidneys were retrieved from a deceased donor, and one of the
two was discarded and the other used in a transplant, it was often the
case that these ``discarded organs could have possibly demonstrated
excellent performance if transplanted'' and ``the use of even a
fraction of them could substantially reduce the number of patients who
never receive an organ.'' As for the cause of these discards, the
authors analyzed several factors and stated that ``the current report
card system for transplant centers in the

[[Page 47706]]

United States . . . creates a disincentive to broader organ acceptance
for centers concerned about payment penalties'' and that ``realignment
of [these] incentives to promote more appropriate utilization is a key
factor in reducing discards.'' (Syed Ali Husain, et al. Characteristics
and Performance of Unilateral Kidney Transplants from Deceased Donors.
Clinical Journal American Society of Nephrology 13: 2018.)
We also received comments and feedback from pertinent stakeholders
in the transplant community that align with the conclusions of these
studies. For instance, UNOS has presented at public meetings that up to
\1/3\ of kidneys that are discarded could be successfully transplanted.
Furthermore, the transplant community has noted that transplant
programs may not use these kidneys due to the perception that they are
of higher risk and that the utilization of these kidneys may lead to
outcomes non-compliance under Sec. 482.82. These programs have avoided
using these kidneys for fear of non-compliance with the CoPs and
potential Medicare termination of the program, despite evidence to the
contrary that demonstrates that the use of these kidneys would not pose
a problem for transplant recipients. The transplant community has
therefore concluded that the regulations have led to behavioral changes
in organ selection and transplantation on patients with fewer
comorbidities and lower risk. This has resulted in transplant programs
potentially avoiding performing transplant procedures on certain
patients and many organs going unused.
While it was our intent to ensure quality of care in transplant
programs with the implementation of the regulations in Sec. 482.82, we
acknowledge that the final regulation may have caused unintended
consequences that impact transplantation and transplant programs in the
U.S. Given the findings of published studies and articles, and the
public feedback we have received, we believe that it is appropriate to
remove these requirements for re-approval of transplant programs in the
Medicare program.
Therefore, we propose to remove the requirements at Sec. 482.82
that require transplant centers to submit data (including, but not
limited to, submission of the appropriate OPTN forms for transplant
candidate registration, transplant beneficiary registration and follow-
up, and living donor registration and follow-up), clinical experience,
and outcome requirements for Medicare re-approval, and make conforming
changes to Sec. 482.102(a)(5) ``Condition of participation, Patient
and living donor rights'' and Sec. 488.61 ``Special Procedures for
Approval and Re-Approval of Organ Transplant Centers.'' Although we
propose to remove these requirements, we continue to strongly believe
that transplant programs should focus on maintaining high standards
that protect patient health and safety and produce positive outcomes
for transplant recipients. Therefore, we will continue to monitor and
assess outcomes, after initial Medicare approval, through the
transplant and hospital QAPI programs. In addition, quality of care
will be monitored by assessing the other transplant program CoPs,
including Sec. Sec. 482.72 through 482.104. We also encourage
transplant programs and their respective hospitals' QAPI programs to
conduct thorough analyses of adverse events, document such events, and
implement improvement activities to prevent recurrences. We further
note that transplant programs must continue to comply with the CoPs at
Sec. Sec. 482.72 through 482.104 and the data submission, clinical
experience, and outcome requirements for initial Medicare approval
under Sec. 482.80. We believe this proposal will eliminate provider
disincentives for performing transplantations and will lead to
increased transplantation opportunities for patients on the waitlist;
improved organ procurement for transplantation; greater organ
utilization; lifesaving effects, reduced burden on transplant programs;
and reductions in costs to both public and private insurance.
We are seeking public comment on the removal of this requirement.
3. Special Procedures for Approval and Re-Approval of Organ Transplant
Centers (Sec. 488.61(f) Through (h))
Section 488.61 describes the survey, certification, and enforcement
procedures for transplant centers, including the periodic review of
compliance and approval as set out at Sec. 488.20. Section 488.61(f)
through (h) set out the process for our consideration of a transplant
center's mitigating factors in initial approval and re-approval
surveys, certifications, and enforcement actions for transplant
centers. The provisions also set out definitions and rules for
transplant systems improvement agreements. We propose to remove the
requirements at Sec. 488.61(f) through (h) for mitigating factors and
transplant systems improvement agreements for the re-approval process
for transplant centers. This change is complementary to the proposed
removal of Sec. 482.82, described previously. We believe that repeal
of these paragraphs would significantly reduce transplant programs'
regulatory burden by no longer requiring them to submit mitigating
factors applications or enter into systems improvement agreements for
outcomes non-compliance (for re-approval surveys, certifications, and
enforcement actions for transplant programs). Transplant programs will
continue to be afforded the opportunity to submit mitigating factors or
to enter into transplant systems improvement agreements during the
initial application process to the Medicare program under Sec. 488.61
(f) through (h).
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on transplant programs and create cost
savings, while also preserving quality of care and patient health and
safety. Consistent with our ``Patients Over Paperwork Initiative,'' we
are particularly interested in any suggestions to improve existing
requirements, within our statutory authority, where they make providing
quality care difficult or less effective. We also note that such
suggestions could include or expand upon comments submitted in response
to the RFI that was included in the FY 2018 Hospital Inpatient
Prospective Payment System for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System proposed rule. Public comments
in response to this RFI can be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0055. Public comments on the RFI
can be found by searching for the terms ``RFI'' or ``request for
information'' in the aforementioned 2017 payment regulation docket on
www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: Alpha-Banu Wilson, 410-786-8687.

F. Home Health Agencies

Home health services are covered for the elderly and disabled under
the

[[Page 47707]]

Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B)
benefits of the Medicare program, and are described in section 1861(m)
of the Social Security Act (the Act). These services, provided under a
plan of care established and periodically reviewed by a physician, must
be furnished by, or under arrangement with, a home health agency (HHA)
that participates in the Medicare or Medicaid programs. Services are
provided on a visiting basis in the beneficiary's home, and may include
the following:
Part-time or intermittent skilled nursing care furnished
by or under the supervision of a registered professional nurse.
Physical therapy, speech-language pathology, and
occupational therapy.
Medical social services under the direction of a
physician.
Part-time or intermittent home health aide services.
Medical supplies (other than drugs and biologicals) and
durable medical equipment.
Services of interns and residents if the HHA is owned by
or affiliated with a hospital that has an approved medical residency
training program.
Services at hospitals, skilled nursing facilities, or
rehabilitation centers when the services involve equipment too
cumbersome to bring to the home.
Under the authority of sections 1861(o) and 1891 of the Act, the
Secretary has established in regulations the requirements that an HHA
must meet to participate in the Medicare program. These requirements
are set forth in regulations at 42 CFR part 484, Home Health Services.
1. Patient Rights (Sec. 484.50(a)(3) and (c)(7))
Section 484.50(a)(3) of the January 2017 HHA CoP final rule (82 FR
4504), effective January 13, 2018, requires HHAs to provide verbal
(meaning spoken) notice of the patient's rights and responsibilities in
addition to the requirement to provide such notice in writing. Section
1891(a)(1)(E) of the Act requires additional oral notice of rights for
specified information as follows:
All items and services furnished by (or under arrangements
with) the agency for which payment may be made under Medicare,
The coverage available for such items and services under
Medicare, Medicaid, and any other Federal program of which the agency
is reasonably aware,
Any charges for items and services not covered under
Medicare and any charges the individual may have to pay with respect to
items and services furnished by (or under arrangements with) the
agency, and
Any changes to the charges or items and services set forth
in the previous bullets.
Section 1891(a)(1)(F) of the Act requires that HHAs provide the
notice of patient rights in writing.
The requirements at Sec. 484.50(a)(3) implement these statutory
requirements, and require spoken notice of all patient rights, rather
than limiting such notice to those rights specified in the Act. On July
28, 2017, we published a proposed rule entitled ``CY 2018 Home Health
Prospective Payment System Rate Update; Home Health Value Based
Purchasing Model; and Home Health Quality Reporting Requirements'' (82
FR 35270) that solicited public comments on ways to reduce regulatory
burden. In response to this solicitation, we received feedback from HHA
stakeholders that the requirement to provide verbal notice of all
rights to patients and their representatives was overly burdensome to
the HHA clinicians that would be required to discuss the notice with
patients when they could be furnishing hands-on patient care during
that time, and lacked evidence that such explanations would result in
improvements to patient safety or care. Furthermore, comments received
encouraged us to reexamine all burdens in the January 2017 HHA CoP
final rule to weigh potential benefits against estimated costs.
We believe that the concerns expressed by commenters have merit. In
light of this information, we believe that any benefits of this
requirement are outweighed by the burdens imposed by this requirement.
For this reason, we propose to delete the requirement that HHAs must
provide verbal notification of all patient rights. This change would be
consistent with the notice of patient rights requirements for other
outpatient provider types, such as hospices, ambulatory surgery
centers, and community mental health centers, for which written notice
of patient rights is the only requirement. We propose to limit the
verbal notification requirements to those requirements set out in
section 1891(a)(1)(E) of the Act for which verbal notification is
mandatory. We propose to revise Sec. 484.50(c)(7) to implement this
more limited verbal notification requirement. Revised Sec.
484.50(c)(7) would require HHAs to verbally discuss HHA payment and
patient financial liability information with each HHA patient as
described above.
This change would not prevent states or Accrediting Organizations
(AOs) from independently establishing and enforcing verbal notification
requirements for all patient rights for purposes other than the HHA
CoPs, nor would it prohibit HHAs from providing such verbal
notification of all patient rights in the absence of Federal
regulation. Furthermore, this change would not alter the other
requirements at Sec. 484.50(a), which requires HHAs to provide the
notice of patient rights in writing, nor would it alter the
requirements at Sec. 484.50(f), Accessibility, which requires HHAs to
provide information to patients in plain language and in a manner that
is both accessible and timely to: (1) Persons with disabilities in
accordance with the Americans with Disabilities Act and Section 504 of
the Rehabilitation Act, and (2) persons with limited English
proficiency. While HHAs would no longer be required to provide a verbal
notification of all patient rights, we would continue to expect that
HHAs answer any questions from patients or their representatives
regarding the content of the written notice of rights. We believe that
this proposed change would continue to provide adequate notice to
patients while reducing burden on HHAs.
2. Home Health Aide Services (Sec. 484.80(h)(3))
Section 484.80(h)(3) of the January 2017 HHA CoP final rule (82 FR
4504) requires that, when a supervisory visit identifies a deficiency
in a home health aide's skills, the HHA must conduct, and the aide must
complete, a full competency evaluation to assess all aide skills and
identify any other skill deficiencies that were not identified while
observing the aide performing care with a patient. In public comments
submitted for the July 2017 proposed rule ``CY 2018 Home Health
Prospective Payment System Rate Update'' (82 FR 35270), a commenter
suggested that completing a full competency evaluation was overly
burdensome for HHAs and aides. Although this comment was not submitted
during the proposed rule public comment period for the HHA CoP proposed
rule, we believe that the concern expressed by the commenter has merit.
In light of this new comment, we reconsidered the requirement, and
concluded that a full competency evaluation is unnecessary and overly
burdensome when only certain skills have been identified as deficient.
We propose to eliminate the requirement to conduct a full competency
evaluation, and replace it with a requirement to retrain the aide
regarding the identified deficient skill(s) and require the aide to
complete a

[[Page 47708]]

competency evaluation related only to those skills. This targeted
retraining and competency evaluation requirement would reduce the time
spent completing competency evaluations and retraining efforts.
3. Clinical Records (Sec. 484.110(e))
In the January 2017 HHA CoPs final rule (82 FR 4504), effective
January 13, 2018, we finalized a requirement, codified at Sec.
484.110(e), that an HHA must make available, upon request, a copy of
the patient's clinical record at the next home visit, or within 4
business days (whichever comes first). In response to the July 2017
proposed rule solicitation of public comment on burden reduction via
the CY 2018 Home Health Prospective Payment System Rate Update (82 FR
35270), we received feedback from HHA stakeholders that this
requirement was impractical for HHAs to comply with because providing
the record at the next visit may not allow enough time for HHAs to
create a physical or electronic copy of the clinical record content,
provide that copy to the next visiting clinician who may not be
scheduled to come into the HHA office prior to the visit due to the
nature of home based care and the significant travel that HHA
clinicians must do in order to make patient visits, and successfully
deliver the copy to the patient. The comments suggested that the 4
business day timeline was more practical and is an appropriate
regulatory requirement. We agree that providing the record at the next
visit is not practical or even possible in some cases. Furthermore, we
agree that retaining the 4 business day timeframe is an appropriate
regulatory requirement. Therefore, we propose to remove the requirement
that the requested clinical record copy must be provided at the next
home visit.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction. Specifically, we
are seeking public comment on additional proposals or modifications to
the proposals set forth in this rule that would further reduce burden
on HHAs and create cost savings, while also preserving quality of care
and patient health and safety. Consistent with our ``Patients Over
Paperwork Initiative,'' we are particularly interested in any
suggestions to improve existing requirements, within our statutory
authority, where they make providing quality care difficult or less
effective.
We also note that such suggestions could include or expand upon
comments submitted in response to the RFI that was included in the CY
2018 Home Health Prospective Payment System Rate Update; Value-Based
Purchasing Model; and Quality Reporting Requirements. Public comments
in response to this RFI can be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0100. Public comments on the RFI
can be found by searching for the terms ``RFI'' or ``request for
information'' in the aforementioned 2017 payment regulation docket on
www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: Danielle Shearer, 410-786-6617.

G. Comprehensive Outpatient Rehabilitation Facilities (CORFs)--
Utilization Review Plan (Sec. 485.66)

Section 485.51 of our rules defines a Comprehensive Outpatient
Rehabilitation Facility (CORF) as a nonresidential facility that is
established and operated exclusively for the purpose of providing
diagnostic, therapeutic, and restorative services to outpatients for
the rehabilitation of injured, disabled, or sick persons, at a single
fixed location, by or under the supervision of a physician. As of May
2017, there were 188 Medicare-certified CORFs in the United States.
Section 1861(cc)(2)(G) of the Act requires CORFs to maintain
utilization review programs. Under this authority, the Secretary has
established requirements at Sec. 485.66 with respect to such programs.
Currently, Sec. 485.66 requires the CORF to have in effect a written
utilization review plan that is implemented at least each quarter, to
assess the necessity of services and promotes the most efficient use of
services provided by the facility.
We propose to amend the utilization review plan requirements at
Sec. 485.66 to reduce the frequency of utilization reviews. We believe
the requirement to implement a utilization review plan 4 times a year
is overly burdensome and diverts staff from providing patient care. We
propose to require the utilization review plan be implemented annually
by the facility, which would allow an entire year to collect and
analyze data to inform changes to the facility and the services
provided. Changing the requirement from a quarterly to an annual review
would not preclude the CORF from implementing their utilization review
plan more frequently, if required by facility policy. We believe that
an annual utilization review plan will serve as a useful measurement
tool for the facility, and that the change from quarterly to annual
would not negatively affect patient health and safety.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on CORFs and create cost savings, while
also preserving quality of care and patient health and safety.
Consistent with our ``Patients Over Paperwork'' Initiative, we are
particularly interested in any suggestions to improve existing
requirements, within our statutory authority, where they make providing
quality care difficult or less effective. We also note that such
suggestions could include or expand upon comments submitted in response
to RFIs that were included in the 2017 payment regulations. We refer
readers to the public comments that were submitted in response to the
RFI for the following 2017 payment regulations:
End-Stage Renal Disease Prospective Payment System and
Payment for Renal Dialysis Services Furnished to Individuals with Acute
Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
found at https://www.regulations.gov/docket?D=CMS-2017-0084.
CY 2018 Home Health Prospective Payment System Rate
Update; Value-Based Purchasing Model; and Quality Reporting
Requirements found at https://www.regulations.gov/docket?D=CMS-2017-0100.
FY 2018 Hospice Wage Index and Payment Rate Update and
Hospice Quality found at https://www.regulations.gov/document?D=CMS-2017-0062-0001.
FY 2018 Hospital Inpatient Prospective Payment System for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System RFI, found at https://www.regulations.gov/docket?D=CMS-2017-0055.

[[Page 47709]]

CY 2018 Hospital Outpatient PPS Policy Changes and Payment
Rates and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates found at https://www.regulations.gov/docket?D=CMS-2017-0091.
FY 2018 Inpatient Rehabilitation Facility Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0059-0002.
FY 2018 Inpatient Psychiatric Facilities Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2018-0053-0002.
CY 2018 Revisions to Payment Policies under the Physician
Fee Schedule and Other Revisions to Part B found at https://www.regulations.gov/docket?D=CMS-2017-0092.
FY 2018 Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities found at https://www.regulations.gov/document?D=CMS-2017-0060-0002.
Public comments on the RFIs can be found by searching for the terms
``RFI'' or ``request for information'' in the aforementioned 2017
payment regulation dockets on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.

H. Critical Access Hospitals

1. Organizational Structure (Sec. 485.627(b)(1))
Current regulations at Sec. 485.627 require CAHs to disclose the
names and addresses of its owners, those with a controlling interest in
the CAH or in any subcontractor in which the CAH directly or indirectly
has a 5 percent or more ownership interest, in accordance with 42 CFR
part 420, subpart C. Section 42 CFR part 420, subpart C, sets forth
requirements for providers, Part B suppliers, intermediaries, and
carriers to disclose ownership and control information and sets forth
requirements for disclosure of information about a provider's or Part B
supplier's owners and those with a controlling interest.
The disclosure of ownership provisions at 42 CFR part 420, subpart
C, are also required under the provider agreement rules under 42 CFR
part 489. The term ``provider agreement'' is defined in Sec. 489.3 as
an agreement between CMS and a provider or supplier to provide services
to Medicare beneficiaries and to comply with the requirements of
section 1866 of the Act (Agreements with Providers of Services;
Enrollment Processes). Providers must meet the terms of the agreement
to be qualified to participate in the Medicare program.
We propose to remove this disclosure requirement from the CAH CoPs
as it is duplicative of requirements for the provider agreement.
Specifically, disclosure of individuals with a financial interest in
the CAH is a requirement under the provider agreement rules in Sec.
489.12(a)(2) and must be completed during the provider enrollment
process. This information must be disclosed on the provider's Medicare
enrollment application (Form CMS-855A for CAHs) and the enrollment
application must be updated with any changes, such as address changes,
practice name or change of ownership of information and must be
submitted to CMS. Also note that this is not a requirement in the
hospital CoPs under 42 CFR part 482 because it is already a requirement
in the provider agreement rules under Sec. 498.12(a)(2).
Contact: Kianna Banks, 410-786-3498.
2. Provision of Services (Sec. 485.635(a)(4))
Current regulations at Sec. 485.635 require CAHs to review
policies and procedures annually. We believe that medical practice has
evolved such that we can provide flexibility for facilities to review,
correct, or change their policies and procedures. Based on our
experience with medical care providers and information from
organizations such as the Brookings Institution (https://www.brookings.edu/testimonies/improving-health-care-quality-the-path-forward/), the expanded use of Web-based information and resources has
fundamentally changed patient care, medical practice, and education. It
has enabled providers to easily adjust policies and procedures on an
as-needed basis. We believe that a prescriptive requirement to review
policies and procedures annually could be eliminated to allow providers
to review biennially and update as necessary, or more frequently if
needed. For example, we expect providers to update their policies and
procedures as needed in response to regulatory changes, changes in the
standard of care, or nationally recognized guidelines.
The current CoP at Sec. 485.635(a)(4) requires a CAH to review its
policies at least annually by the CAH's professional healthcare staff,
including one or more doctors of medicine or osteopathy and one or more
physician assistants, nurse practitioners, or clinical nurse
specialists, if they are on staff under the provisions of Sec.
485.631(a)(1). The policies that are reviewed must include the
following:
A description of the services the CAH furnishes, including
those furnished through agreement or arrangement;
Policies and procedures for emergency medical services;
Guidelines for the medical management of health problems
that include the conditions requiring medical consultation and/or
patient referral, the maintenance of health care records;
Rules for the storage, handling, dispensation, and
administration of drugs and biologicals;
Procedures for reporting adverse drug reactions and errors
in the administration of drugs; and
A system for identifying, reporting, investigating and
controlling infections and communicable diseases of patients and
personnel.
Procedures that ensure that the nutritional needs of post-
hospital SNF inpatients are met in accordance with recognized dietary
practices.
Based on feedback from stakeholders, the prescriptive annual
schedule can be burdensome or, in some situations, ineffective.
Providers stated that they make annual, monthly and biannual changes to
their policies. Some have stated that they make changes as needed or
infrequently. They also stated that the time that it took to review the
policies varied. Some stated it would take as little as 2 hours while a
few stated a much longer period time such as a month, depending on what
was being changed. We believe that taking a month would represent a new
facility or a facility that is experiencing major restructuring. After
a careful review of the varied responses, we propose to provide
flexibility and reduce burden by revising the requirement at Sec.
485.635(a)(4) to, at a minimum, only require a biennial review of
policies and procedures. The 2-year review would not preclude a
facility from conducting a review more frequently if needed or
organizing the review such that it would be completed over a 2-year
period. Based on our experience with other providers, we believe that
this approach would allow CAHs to maintain their health and safety
policies in such a manner as to achieve the intended outcomes for all
patients. Thus, we propose to change the requirement at Sec.
485.635(a)(4) from ``annual'' to ``biennial''.
Contact: Mary Collins, 410-786-3189.

[[Page 47710]]

3. Special Requirements for CAH Providers of Long-Term Care Services
(``Swing-Beds'') (Sec. 485.645(d)(1), (4), (5) and (8))
The special requirements for CAH swing-bed providers are nearly
identical to the requirements for hospital providers of swing-bed
services. As a result, please refer to the discussion on the special
requirements for hospital providers of swing-bed services under section
II.D.3 for the details of the proposed changes for these requirements.
We propose the following revisions to the CAH swing-bed requirements:
Revision of Sec. 485.645(d)(1) to remove the cross-
referenced long-term care requirement in Sec. 483.10(f)(9), which
requires that CAH swing-bed providers to offer residents the right to
choose to or refuse to perform services for the facility and prohibits
a facility from requiring a resident to perform services for the
facility;
Removal of Sec. 485.645(d)(4), which requires CAH swing-
bed providers to provide an ongoing activity program that is directed
by a qualified therapeutic recreation specialist or an activities
professional who meets certain requirements (cross-referenced long-term
care requirement Sec. 483.24(c));
Redesignation of paragraphs (d)(5) through (9) as (d)(4)
through (8), respectively;
Revision of Sec. 485.645(d)(4) (as redesignated) to
remove the cross-referenced long-term care requirement Sec. 483.70(p),
which requires that CAH swing-bed providers with more than 120 beds to
employ a qualified social worker on a full-time basis; and
Revision of Sec. 485.645(d)(7) (as redesignated) to
remove the cross-referenced long-term care requirement Sec.
483.55(a)(1), which requires CAH swing-bed providers to assist in
obtaining routine and 24-hour emergency dental care to its residents.
Contact: Kianna Banks, 410-786-3498.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on CAHs and create cost savings, while also
preserving quality of care and patient health and safety. Consistent
with our ``Patients Over Paperwork'' Initiative'' we are particularly
interested in any suggestions to improve existing requirements, within
our statutory authority, where they make providing quality care
difficult or less effective. We also note that such suggestions could
include or expand upon comments submitted in response to the FY 2018
Hospital Inpatient Prospective Payment System for Acute Care Hospitals
and the Long-Term Care Hospital Prospective Payment System RFI, found
at https://www.regulations.gov/docket?D=CMS-2017-0055. Public comments
on the RFI can be found by searching for the terms ``RFI'' or ``request
for information'' in the aforementioned 2017 payment regulation docket
on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.

I. Community Mental Health Center (Sec. 485.914(d))

On October 29, 2013, we published a final rule (78 FR 209) that
established, for the first time, a set of requirements that Medicare-
certified CMHCs must meet in order to participate in the Medicare
program. These CoPs ensure the quality and safety of CMHC care for all
clients served by the CMHC, regardless of payment source. These
requirements focus on a person-centered, outcome-oriented process that
promotes quality client care. These CoPs are set forth at 42 CFR part
485 and apply to all Medicare participating CMHCs.
Medicare certified CMHCs provide services to a wide range of
clients, from those needing partial hospitalization program (PHP)
services to clients needing routine counseling. Partial hospitalization
services are an intense level of services needed ``to improve or
maintain the individual's condition and functional level and to prevent
relapse or hospitalization. . . .'' (section 1861(ff)(2) of the Act).
As written, the current standard at Sec. 485.914(d) requires the CMHC
to update the client comprehensive assessment every 30 days regardless
of the client's needs or treatment schedule. This 30 day update of the
comprehensive assessment correlates with the CMS PHP payment
regulations, requiring PHP clients to receive an updated active
treatment plan every 30 days. Clients receiving PHP are more acute and
typically receive care in the CMHC multiple days a week for several
hours a day. The PHP client will have changing needs as they progress
through their treatment plan; therefore, updating the assessment every
30 days or sooner if the client's condition changes continues to be an
important requirement for the PHP client.
While the minimum 30 day update time fame at Sec. 485.914(d) is
needed for clients receiving PHP services, we do not believe that this
time frame requirement supports the needs of all CMHC clients. Clients
that do not receive PHP services may be seen weekly or every 2 weeks,
while others are only seen every 2-6 months for a medication follow up.
Requiring an updated assessment every 30 days may not be practical for
the non-PHP client, causing either additional visits or phone calls
from the CMHC to the client to document ``no changes in the client's
assessment''. This is not an efficient use of CMHC clinician or client
time. Therefore, we propose to modify this standard at Sec.
485.914(d)(1) to require that the CMHC update each client's
comprehensive assessment via the CMHC interdisciplinary treatment team,
in consultation with the client's primary health care provider (if
any), when changes in the client's status, responses to treatment, or
goal achievement have occurred, and in accordance with current
standards of practice. Additionally at Sec. 485.914(d)(3), we propose
to retain the minimum 30 day assessment update time frame for those
clients who receive PHP services. We believe this proposed change will
allow for the provider and client to choose a visit schedule that is
appropriate for the client's condition and not cause extra work or time
for documentation that is unnecessary. Ultimately, this proposed change
may allow for greater flexibility for the provider and client, saving
time for both.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on CMHCs and create cost savings, while
also preserving quality of care and patient health and safety.
Consistent with our ``Patients Over Paperwork Initiative,'' we are
particularly interested in any suggestions to improve existing

[[Page 47711]]

requirements, within our statutory authority, where they make providing
quality care difficult or less effective. We also note that such
suggestions could include or expand upon comments submitted in response
to the RFI that was included in the CY 2018 OPPS/ASC proposed rule.
Public comments in response to this RFI can be found at the following
link: https://www.regulations.gov/docket?D=CMS-2017-0091. Public
comments on the RFI can be found by searching for the terms ``RFI'' or
``request for information'' in the aforementioned 2017 payment
regulation docket on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: CAPT Mary Rossi-Coajou, USPHS, 410-786-6051.

J. Portable X-Ray Services (Sec. Sec. 486.104(a) and 486.106(a))

Portable x-rays are basic radiology studies (predominately chest
and extremity x-rays) performed on patients in skilled nursing
facilities, residents of long term care facilities and homebound
patients. Under the authority of section 1861(s)(3) of the Act, the
Secretary has established the CfCs that the supplier of portable x-ray
services must meet to participate in Medicare and Medicaid, and these
conditions are set forth at Sec. Sec. 486.100 through 486.110. The
portable x-ray CfCs set forth at Sec. 486.104 were originally
published on January 10, 1969 (34 FR 388) and were redesignated on
September 30, 1977 (42 FR 528260), and amended on April 12, 1988 (53 FR
12015), August 30, 1995 (60 FR 45086), and November 19, 2008 (73 FR
69942). The portable x-ray CfCs set forth at Sec. 486.106 were
originally published on January 10, 1969 (34 FR 388) and were
redesignated on September 30, 1977 (42 FR 52826) and further
redesignated and amended January 9, 1995 (60 FR 2326), August 30, 1995
(60 FR 45086), and November 16, 2012 (77 FR 69372). The November 2012
revision to the portable x-ray requirements allowed nurse practitioners
and non-physician providers acting within their scope of practice to
order portable x-ray studies. The current regulations are inconsistent
with other rules governing diagnostic studies, as described later in
this section of this proposed rule. In order to improve consistency, we
propose changes to both Sec. 486.104, Condition for coverage:
Qualifications, orientation and health of technical personnel and Sec.
486.106, Condition for coverage: Referral for service and preservation
of records.
At Sec. 486.104, Condition for coverage: Qualifications,
orientation and health of technical personnel, the portable x-ray
technologist must meet any one of four training and education
requirements in Sec. 486.104(a)(1), (2), (3), or (4). The requirement
focuses on the accreditation of the school rather than the competency
of the individual. In contrast, Sec. 482.26(c)(2), referring to
qualifications of radiologic technologists in hospitals, is focused on
the qualifications of the individual performing services as permitted
by State law. Additionally, Sec. 410.33(c), which sets forth the
personnel requirements for non-physician personnel used by an
independent testing facility to perform tests, requires that testing
personnel, including x-ray technologists, must demonstrate the basic
qualifications to perform the tests in question and have training and
proficiency as evidenced by licensure or certification by the
appropriate State health or education department. These two other
regulatory requirements that govern the same type of technologists do
not have any accreditation requirements. Based on our survey findings
in hospitals, which have not identified widespread patient safety or
quality of care concerns related to the training and education levels
of technologists, we do not believe that removing the school
accreditation requirement from the portable x-ray personnel
requirements would negatively impact portable x-ray patient health and
safety.
We propose to remove the four training and education requirements
for two reasons. First, paragraph (a)(1), and to some extent paragraph
(a)(4), focus on the accreditation of the school where the technologist
received training, instead of focusing on the qualifications of the
technologist performing the diagnostic test. Radiologic technicians who
practice in a hospital, and for whom there are no requirements to
receive education and training by an accredited program, are legally
allowed to perform any diagnostic imaging procedure, including computed
topography scans, mammograms, sonograms, and many other procedures that
are more complex and require more expertise than portable x-rays. In
contrast, portable x-ray radiologic technicians typically perform basic
x-rays of the limbs (hand, foot) and chest, and are limited in their
duties by State scope of practice rules. For this reason we are
aligning the current requirements at Sec. 486.104(a)(1), (2), (3), and
(4) with Sec. 482.26(c)(2), which refers to qualifications of
radiologic technologists in hospitals, and is focused on the
qualifications of the individual performing services as permitted by
State law. This change would not preclude state licensure entities and
portable x-ray suppliers from establishing personnel requirements that
are more stringent that the proposed Federal requirements.
Second, paragraphs (a)(2), (3), and (4) establish different
personnel qualifications based on the date that a technologist received
his or her education and training. We do not believe that it is
efficient or necessary to have varying qualifications based simply on
the date that such training was received. We propose to replace these
four different qualifications with a single, streamlined qualification
that focuses on the skills and abilities of the technologist. We
believe that removing school accreditation requirements and simplifying
the requirements will reduce regulatory burden, streamline the hiring
process, and widen the pool of individuals who may be employed by
portable x-ray suppliers to perform portable x-ray services,
particularly those individuals who received training through the
military for performing portable x-rays, as military training programs
are not accredited.
Section 486.106(a)(2) contains specific requirements for the
content of the order for portable x-ray services, and requires that
physician or non-physician practitioners orders for portable x-ray
services must be written and signed. The requirements at Sec.
486.106(a)(2) are inconsistent with the order requirements at Sec.
410.32, which also apply to portable x-ray suppliers, in two ways.
First, the requirements at Sec. 486.106(a)(2) have different order
content requirements. Second, the requirements at Sec. 486.106(a)(2)
have the effect of limiting or precluding telephonic and electronic
orders, which are often more efficient ordering methods. Section 410.32
allows for the diagnostic service to be ordered in writing, by
telephone, or by secure electronic methods. Although, Sec. 410.32 does
not prescribe the form of an order. The Medicare Benefit Policy Manual
(Pub. 100-02), chapter 15, section 80.6 provides additional guidance on
Sec. 410.32, and states:
``An order may be delivered via the following forms of
communication:
A written document signed by the treating physician/
practitioner, which is hand delivered, mailed, or faxed to the testing
facility; NOTE: No signature is required on orders for clinical
diagnostic tests paid on the basis of the

[[Page 47712]]

clinical laboratory fee schedule, the physician fee schedule, or for
physician pathology services;
A telephone call by the treating physician/practitioner or
his or her office to the testing facility; and
An electronic mail by the treating physician/practitioner
or his or her office to the testing facility.
If the order is communicated via telephone, both the treating
physician/practitioner or his or her office, and the testing facility
must document the telephone call in their respective copies of the
beneficiary's medical records. While a physician order is not required
to be signed, the physician must clearly document, in the medical
record, his or her intent that the test be performed.
We propose to update Sec. 486.106 (specific to portable x-ray
services) to cross reference the requirements at Sec. 410.32. We
propose to retain the requirement that the portable x-ray order must
include a statement on why it is necessary to perform a portable x-ray
as opposed to performing the study in a facility where x-rays are more
typically performed. This change would allow for portable x-ray
services to be ordered in writing, by telephone, or by electronic
methods. The change would also streamline the ordering process by
avoiding the need to write two separate orders for the same study, one
to meet the Medicare payment requirements in accordance with Sec.
410.32 and its associated Manual guidance, and another to meet the
content requirements of the regulation set forth at Sec. 486.106. We
believe the proposed change would allow for additional ordering
flexibility to streamline ordering practices while maintaining ordering
and documentation requirements consistent with all other diagnostic
testing.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on suppliers of portable x-ray services and
create cost savings, while also preserving quality of care and patient
health and safety. Consistent with our ``Patients Over Paperwork
Initiative,'' we are particularly interested in any suggestions to
improve existing requirements, within our statutory authority, where
they make providing quality care difficult or less effective. We also
note that such suggestions could include or expand upon comments
submitted in response to the RFI that was included in the CY 2018
Revisions to Payment Policies under the Physician Fee Schedule and
Other Revisions to Part B. Public comments in response to this RFI can
be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0092. Public comments on the RFI can be found by
searching for the terms ``RFI'' or ``request for information'' in the
aforementioned 2017 payment regulation docket on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: Sonia Swancy, 410-786-8445.

K. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)

1. Provision of Services (Sec. 491.9(b)(4))
Currently, Sec. 491.9(b)(4) requires RHCs and FQHCs to have their
patient care policies reviewed at least annually by the designated
group of professional personnel who advise the RHC or FQHC in
developing these policies (described at Sec. 491.9(b)(2)), and
reviewed as necessary by the RHC or FQHC. We propose to reduce the
frequency of policy reviews. We believe the requirement to review
patient care policies annually is burdensome and diverts staff from
providing patient care. We propose to require the patient care policies
be reviewed on a biennial basis by the group of professional personnel.
Changing the review requirement from annually to every other year would
not preclude the RHC or FQHC from maintaining their current annual
review, if they believe it is necessary or if it is required by
facility policy. We believe that this approach would allow RHCs and
FQHCs to maintain their health and safety policies in such a manner as
to achieve the intended outcomes for all patients. Thus, we propose to
change the requirement at Sec. 491.9(b)(4) from ``annual'' to
``biennial''.
2. Program Evaluation (Sec. 491.11(a))
The current requirement at Sec. 491.11(a) requires that the RHC or
FQHC carries out, or arranges for, an annual evaluation of its total
program. Some RHCs and FQHCs have reported to us that this requirement
is burdensome and utilizes costly staff resources. We propose to revise
the current requirement at Sec. 491.11(a) by changing the frequency of
the RHC or FQHC evaluation from annually to every other year. The
revised requirement would then require a biennial evaluation of its
total program. Changing the program evaluation requirement from
annually to every other year would not preclude the RHC or FQHC from
conducting an evaluation more frequently or maintaining their current
annual evaluation, if they believe it is necessary or if it is required
by facility policy. Furthermore, the proposed changes would give the
RHC or FQHC the flexibility to focus only on certain program areas, if
they choose to do so, for the off year in-between required program
evaluations. The proposed change would reduce the paperwork burden of
the RHC or FQHC and allow clinicians to focus more on patient care. We
believe that an evaluation of the RHC or FQHC's total program every
other year is sufficient to ensure consistent quality of care, and that
the change from annual to biennial would not negatively affect patient
health and safety. We welcome the public's comments on these proposed
changes.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on RHCs and FQHCs and create cost savings,
while also preserving quality of care and patient health and safety.
Consistent with our ``Patients Over Paperwork'' Initiative, we are
particularly interested in any suggestions to improve existing
requirements, within our statutory authority, where they make providing
quality care difficult or less effective. We also note that such
suggestions could include or expand upon comments submitted in response
to RFIs that were included in the 2017 prospective payment regulations
for most provider types. We refer readers to the public comments that
were submitted in response to the RFI for the following 2017 payment
regulations:
End-Stage Renal Disease Prospective Payment System and
Payment for Renal Dialysis Services Furnished to Individuals with Acute
Kidney Injury, and End-Stage Renal

[[Page 47713]]

Disease Quality Incentive Program found at https://www.regulations.gov/docket?D=CMS-2017-0084.
CY 2018 Home Health Prospective Payment System Rate
Update; Value-Based Purchasing Model; and Quality Reporting
Requirements found at https://www.regulations.gov/docket?D=CMS-2017-0100.
FY 2018 Hospice Wage Index and Payment Rate Update and
Hospice Quality found at https://www.regulations.gov/document?D=CMS-2017-0062-0001.
FY 2018 Hospital Inpatient Prospective Payment System for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System RFI, found at https://www.regulations.gov/docket?D=CMS-2017-0055.
CY 2018 Hospital Outpatient PPS Policy Changes and Payment
Rates and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates found at https://www.regulations.gov/docket?D=CMS-2017-0091.
FY 2018 Inpatient Rehabilitation Facility Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0059-0002.
FY 2018 Inpatient Psychiatric Facilities Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0105-0002.
CY 2018 Revisions to Payment Policies under the Physician
Fee Schedule and Other Revisions to Part B found at https://www.regulations.gov/docket?D=CMS-2017-0092.
FY 2018 Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities found at https://www.regulations.gov/document?D=CMS-2017-0060-0002.
Public comments on the RFIs can be found by searching for the terms
``RFI'' or ``request for information'' in the aforementioned 2017
payment regulation dockets on www.regulations.gov.
The most useful comments will be those that include data or
evidence to support the position, offer suggestions to amend specific
sections of the existing regulations, or offer particular additions.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.

L. Emergency Preparedness for Providers and Suppliers

On September 16, 2016, we published a final rule entitled,
``Medicare and Medicaid Programs; Emergency Preparedness Requirements
for Medicare and Medicaid Participating Providers and Suppliers'' (81
FR 63860), which established national emergency preparedness
requirements for Medicare and Medicaid participating providers and
suppliers (referred to collectively as ``facilities'' in the subsequent
section) to plan adequately for both natural and man-made disasters and
coordinate with Federal, State, tribal, regional, and local emergency
preparedness systems. In that final rule, we emphasized the need for
facilities to maintain access to healthcare services during
emergencies, safeguard human resources, and maintain business
continuity and protect physical resources. A facility's emergency
preparedness program must include the following elements:

Risk assessment and emergency planning
Policies and procedures
Communication plan
Training and testing

After the publication of that final rule, we continued to review
and analyze the final emergency preparedness requirements and pertinent
stakeholder feedback. Upon further review, we believe that some
emergency preparedness requirements could be modified or eliminated to
reduce provider and supplier burden while continuing to maintain
essential emergency preparedness requirements that preserve the health
and safety of patients in the United States. The following proposals
would simplify the emergency preparedness requirements, eliminate
duplicative requirements, and/or reduce the frequency with which
providers and suppliers would need to perform certain required
activities. We note that the current emergency preparedness standards
are similar amongst all provider and supplier types, with a few
variations to account for differences in health care settings. For
clarity in the discussion later in this section of this proposed rule,
we often refer to the hospital regulatory citation and we include
specific references to other provider or supplier types when necessary.
1. Annual Review of Emergency Preparedness Program (Sec. Sec. 403.748,
416.54, 418.113, 441.184, 460.84, 482.15, 483.73, 483.475, 484.102,
485.68, 485.625, 485.727, 485.920, 486.360, 491.12, and 494.62 (a),
(b), (c), and (d))
Facilities are currently required to annually review their
emergency preparedness program, which includes a review of their
emergency plan, policies and procedures, communication plan, and
training and testing program. However, pertinent stakeholders continue
to question whether an annual review of the emergency program is
necessary or beneficial to the facility. In response to their comments,
we are therefore proposing to change this requirement to require
facilities to review their program at least every 2 years. This will
increase the facility's flexibility to review their programs as they
determine best fits their needs. We expect that facilities would
routinely revise and update their policies and operational procedures
to ensure that they are operating based on best practices. In addition,
facilities should update their emergency preparedness program more
frequently than every 2 years as needed (for example, if staff changes
occur or lessons-learned are acquired from a real-life event or
exercise).
As noted in the Emergency Preparedness final rule (81 FR 63860),
``. . . there are various infections and diseases, such as the Ebola
outbreak in October, 2014, that required updates in facility
assessments, policies and procedures and training of staff beyond the
directly affected hospitals. The final rule requires that if a facility
experiences an emergency, an analysis of the response and any revisions
to the emergency plan will be made and gaps and areas for improvement
should be addressed in their plans to improve the response to similar
challenges for any future emergencies.''
The Assistant Secretary for Preparedness and Response (ASPR)
Technical Resources, Assistance Center, and Information Exchange
(TRACIE) located at: https://asprtracie.hhs.gov/, is an excellent
resource for the various CMS providers and suppliers as they seek to
implement the emergency preparedness requirements. TRACIE is designed
to provide resources and technical assistance to healthcare system
preparedness stakeholders in building a resilient healthcare system.
There are numerous products and resources located within the TRACIE
website that target specific provider types affected by the emergency
preparedness aspects of this proposed rule. While TRACIE does not focus
specifically on the requirements implemented in this proposed
regulation, this is a valuable resource to aid a wide spectrum of
partners with their health system emergency preparedness activities. We
strongly encourage providers and suppliers to utilize TRACIE and
leverage the information provided by ASPR.

[[Page 47714]]

2. Documentation of Cooperation Efforts (Sec. Sec. 403.748(a)(4),
416.54(a)(4), 418.113(a)(4), 441.184(a)(4), 460.84(a)(4), 482.15(a)(4),
483.73(a)(4), 483.475(a)(4), 484.102(a)(4), 485.68(a)(4),
485.625(a)(4), 485.920(a)(4), 486.360(a)(4), 491.12(a)(4), and
494.62(a)(4))
Facilities are currently required to develop and maintain an
emergency preparedness plan that includes a process for cooperation and
collaboration with local, tribal, regional, State, and Federal
emergency preparedness officials' efforts to maintain an integrated
response during a disaster or emergency situation, including
documentation of the facilities' efforts to contact such officials and,
when applicable, of its participation in collaborative and cooperative
planning efforts. Upon further review of this requirement, we believe
that elements of this requirement are unduly burdensome on facilities.
Therefore, we propose to eliminate the requirement that facilities
document efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials and facilities' participation in
collaborative and cooperative planning efforts. Facilities will still
be required to include a process for cooperation and collaboration with
local, tribal, regional, State and Federal emergency preparedness
officials' efforts to maintain an integrated response during a disaster
or emergency situation. We believe that eliminating this documentation
requirement will reduce provider and supplier burden by not requiring
facilities to demonstrate that they have contacted local, tribal,
regional, State, and Federal emergency preparedness officials or
participated in collaborative and cooperative planning in the
community, while still requiring facilities to at least include a
process for cooperation and collaboration. We continue to encourage
facilities to participate, when available, in community cooperative and
collaborative planning efforts and execute the training and testing
requirements in Sec. 482.15 (d) for hospitals and similar parallel
citations for other facilities.
3. Annual Emergency Preparedness Training Program (Sec. Sec.
403.748(d)(1)(ii), 416.54(d)(1)(ii), 418.113(d)(1)(ii),
441.184(d)(1)(ii), 460.84(d)(1)(ii), 482.15(d)(1)(ii),
483.73(d)(1)(ii), 483.475(d)(1)(ii), 484.102(d)(1)(ii),
485.68(d)(1)(ii), 485.625(d)(1)(ii), 485.727(d)(1)(ii),
485.920(d)(1)(ii), 486.360(d)(1)(ii), 491.12(d)(1)(ii), and
494.62(d)(1)(ii)
Facilities are required to develop and maintain a training program
that is based on the facility's emergency plan. This emergency
preparedness training must be provided at least annually and a well-
organized effective training program must include initial training in
emergency preparedness policies and procedures. We revisited the public
comments received on the Emergency Preparedness proposed rule (81 FR
63890 through 63891) and determined that requiring facilities to
provide annual training may be unduly burdensome. We are therefore
proposing to change this requirement to require that facilities provide
training biennially or every 2 years, after facilities conduct initial
training on their emergency program. In addition, we propose to require
additional training when the emergency plan is significantly updated.
For example, when a facility makes substantial changes to the
procedures or protocols within the emergency plan, we would require
additional training on the updated emergency plan. Other non-
significant updates, such as revisions to the communication plan
regarding contact information for staff, could be sent in company
memorandum or provided to the facility's staff through other means.
These proposed changes give facilities additional flexibility to
determine what is appropriate for their facility's or staff's needs
while maintaining adequate readiness.
4. Annual Emergency Preparedness Testing (Sec. Sec. 403.748(d)(2),
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2),
483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2),
485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 486.360(d)(2),
491.12(d)(2), and 494.62(d)(2))
Facilities are currently required to conduct exercises to test the
emergency plan at least annually. The facility must conduct two
emergency preparedness testing exercises every year. Specifically,
facilities must:
Participate in a full-scale exercise that is community-
based or when a community-based exercise is not accessible, an
individual, facility-based. If the facility experiences an actual
natural or-man made emergency that requires activation of the emergency
plan (including their communication plan) and revision of the plan as
needed), the facility is exempt from engaging in a community-based or
individual, facility based full-scale exercise for 1 year following the
onset of the actual event;
Conduct an additional exercise that may include either a
second full-scale exercise that is community-based or individual,
facility-based or a tabletop exercise that includes a group discussion
led by a facilitator.
Upon further analysis of this requirement, and taking into account
stakeholder feedback, we have determined that there is also a need to
clarify and revise some of the requirements included in the Emergency
Preparedness final rule (81 FR 63860). We propose to clarify our intent
with regard to the types of testing exercises, specifically full-scale
exercises and functional exercises. As noted in the Emergency
Preparedness proposed rule (78 FR 79101), a full-scale exercise is a
multi-agency, multijurisdictional, multi-discipline exercise involving
functional (for example, joint field office, emergency operation
centers, etc.) and ``boots on the ground'' responses (for example,
firefighters decontaminating mock victims). We expect facilities to
engage in such comprehensive exercises with coordination across the
public health system and local geographic area, if possible. Moreover,
a functional exercise examines or validates the coordination, command,
and control between various multiagency coordination centers (for
example, emergency operation center, joint field office, etc.). A
functional exercise does not involve any ``boots on the ground'' (that
is, first responders or emergency officials responding to an incident
in real time). The term ``functional exercise'' more accurately
reflects our intentions for the testing requirement in the Emergency
Preparedness final rule (81 FR 63860). We believe that there are
opportunities to reduce the burden for inpatient and outpatient
providers to meet the testing requirement.
For providers of inpatient services, we propose to expand the
testing requirement options such that one of the two annually required
testing exercises may be an exercise of their choice, which may include
one community-based full-scale exercise (if available), an individual
facility-based functional exercise, a drill, or a tabletop exercise or
workshop that includes a group discussion led by a facilitator. As
indicated in the Emergency

[[Page 47715]]

Preparedness proposed rule, ``A workshop resembles a seminar, but is
employed to build specific products, such as a draft plan or policy
(for example, a Training and Exercise Plan Workshop is used to develop
a Multiyear Training and Exercise Plan)'' (78 FR 79101). Providers of
inpatient services include RNHCIs, inpatient hospice facilities,
Psychiatric Residential Treatment Facilities (PRTFs), hospitals, long-
term care facilities (LTCFs), ICFs/IIDs, and CAHs. We believe this will
allow greater flexibility for inpatient providers to meet this
requirement. We note that although RNHCIs provide inpatient services,
we have determined that changing their existing requirements to make
them consistent with this proposed provision will be unduly burdensome
as they are currently required to conduct a paper-based, tabletop
exercise at least annually.
For providers of outpatient services, we believe that conducting
two testing exercises per year is overly burdensome as these providers
do not provide the same level of acuity or inpatient services for their
patients. Therefore, we propose to require that providers of outpatient
services conduct only one testing exercise per year. Furthermore, we
propose to require that these providers participate in either a
community-based full-scale exercise (if available) or conduct an
individual facility-based functional exercise every other year. In the
opposite years, we propose to allow these providers to conduct the
testing exercise of their choice, which may include either a community-
based full-scale exercise (if available), an individual, facility-based
functional exercise, a drill, or a tabletop exercise or workshop that
includes a group discussion led by a facilitator. Providers of
outpatient services include ASCs, freestanding/home-based hospice,
Program for the All-Inclusive Care for the Elderly (PACE), HHAs, CORFs,
Organizations (which include Clinics, Rehabilitation Agencies, and
Public Health Agencies as Providers of Outpatient Physical Therapy and
Speech-Language Pathology Services), CMHCs, Organ Procurement
Organizations (OPOs), RHCs, FQHCs, and ESRD facilities. Due to the
nature of services provided by OPOs we propose to require that they
have the option of providing either a tabletop exercise or workshop
every year.
Lastly, we propose to clarify the testing requirement exemption by
noting that if a provider experiences an actual natural or man-made
emergency that requires activation of their emergency plan, inpatient
and outpatient providers will be exempt from their next required full-
scale community-based exercise or individual, facility-based functional
exercise following the onset of the actual event. A facility's
communication plan is part of their emergency plan, as is coordination
with other community emergency preparedness officials (for example,
emergency management and public health), and we expect that these
elements, along with the completion of a corrective action plan, are
part of the activation of their emergency plan.
We seek to reduce burdens for health care providers and patients,
improve the quality of care, decrease costs, and ensure that patients
and their providers and physicians are making the best health care
choices possible. Therefore, we are soliciting public comments on
additional regulatory reforms for burden reduction in future
rulemaking. Specifically, we are seeking public comment on additional
proposals or modifications to the proposals set forth in this rule that
would further reduce burden on all Medicare and Medicaid participating
providers and suppliers mentioned in this section and create cost
savings, while also preserving quality of care and patient health and
safety. Consistent with our ``Patients Over Paperwork'' Initiative, we
are particularly interested in any suggestions to improve existing
requirements, within our statutory authority, where they make providing
quality care difficult or less effective. We also note that such
suggestions could include or expand upon comments submitted in response
to RFIs that were included in the following 2017 payment regulations:
End-Stage Renal Disease Prospective Payment System and
Payment for Renal Dialysis Services Furnished to Individuals with Acute
Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
found at https://www.regulations.gov/docket?D=CMS-2017-0084.
CY 2018 Home Health Prospective Payment System Rate
Update; Value-Based Purchasing Model; and Quality Reporting
Requirements found at https://www.regulations.gov/docket?D=CMS-2017-0100.
FY 2018 Hospice Wage Index and Payment Rate Update and
Hospice Quality found at https://www.regulations.gov/document?D=CMS-2017-0062-000.
FY 2018 Hospital Inpatient Prospective Payment System for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System RFI, found at https://www.regulations.gov/docket?D=CMS-2017-0055.
CY 2018 Hospital Outpatient PPS Policy Changes and Payment
Rates and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates found at https://www.regulations.gov/docket?D=CMS-2017-0091.
FY 2018 Inpatient Rehabilitation Facility Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0059-0002.
FY 2018 Inpatient Psychiatric Facilities Prospective
Payment System found at https://www.regulations.gov/document?D=CMS-2017-0105-0002.
CY 2018 Revisions to Payment Policies under the Physician
Fee Schedule and Other Revisions to Part B found at https://www.regulations.gov/docket?D=CMS-2017-0092.
FY 2018 Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities found at https://www.regulations.gov/document?D=CMS-2017-0060-0002.
Public comments on the RFIs can be found by searching for the terms
``RFI'' or ``request for information'' in the aforementioned 2017
payment regulation dockets on www.regulations.gov. The most useful
comments will be those that include data or evidence to support the
position, offer suggestions to amend specific sections of the existing
regulations, or offer particular additions.
Contact: Kianna Banks, 410-786-3498.

III. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of the section
3506(c)(2)(A)-

[[Page 47716]]

required issues for the following information collection requirements
(ICRs).

A. Wages

To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2016 National Occupational Employment and Wage
Estimates for all salary estimates (https://www.bls.gov/oes/2016/may/oes_nat.htm). In this regard, the following table presents the mean
hourly wage, the cost of fringe benefits and overhead costs (calculated
at 100 percent of salary), and the adjusted hourly wage.

National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Adjusted
Occupation title Occupation Mean hourly Fringe benefit hourly wage ($/
code wage ($/hour) ($/hour) hour)
----------------------------------------------------------------------------------------------------------------
Healthcare Support Worker....................... 31-9099 $18.13 $18.13 $36
Physicians and Surgeons......................... 29-1060 101.04 101.04 202
Physicians and Surgeons, All Other.............. 29-1069 98.83 98.83 198
Physicians, Psychiatrists....................... 29-1066 94.26 94.26 189
Surgeons........................................ 29-1067 121.59 121.59 243
Registered Nurse (RN--Quality Improvement, Home 29-1141 34.70 34.70 69
Care Coordinator, HealthCare Trainer, Quality
Assurance Nurse, QAPI Nurse Coordinator,
Infection Control Nurse Coordinator,
Psychiatric RN)................................
Medical Secretary (Clerical, Administrative 43-6013 16.85 16.85 34
Assistant).....................................
Administrative Services Manager (Facility 11-3011 47.56 47.56 96
Director)......................................
Management Occupations (Director, Community 11-0000 56.74 56.74 114
Relations Manager, Administrator)..............
Pharmacist...................................... 29-1051 57.82 57.82 115
Medical and Health Services Manager 11-9111 52.58 52.58 105
(Administrator, Transplant Program Senior
Administrator/Hospital Administrator/Medical
and Health Services Managers, Program Director,
Risk Management Director. QAPI Director, Organ
Procurement Coordinator, Nurse manager,
Director of Nursing, Nursing care facilities/
skilled nursing facilities)....................
Managers, All Others(Administrator)............. 11-9199 53.92 53.92 108
* Activities Specialist (Recreational 29-1125 19.92 19.92 40
Therapists, Nursing Care Facilities/SNFs)......
Internists (Medical Director, General Physician. 29-1063 97.04 97.04 194
Family and General Practitioner (Medical 29-1062 96.54 96.54 194
Director)......................................
Physical Therapist (Director of Rehab).......... 29-1123 41.93 41.93 84
Healthcare Social Worker (Social Worker)........ 21-1022 26.69 26.69 53
Mental Health and Substance Abuse Social Worker 21-1023 23.02 23.02 46
(Social Worker)................................
Nurse Practitioner (Clinician, Nurse 29-1171 50.30 50.30 101
Practitioner Outpatient Care Center)...........
Mental Health Counselor......................... 21-1014 22.14 22.14 44
Physician Assistant............................. 29-1071 49.08 49.08 98
Licensed Practical and Licensed Vocational 29-2061 21.56 21.56 44
Nurses (Director of Nursing)...................
First Line Supervisors of Office and 43-1011 27.83 27.83 56
Administrative Support Workers (Office Manager)
Office Clerks, General (Clerical staff)......... 43-9061 15.87 15.87 32
Secretaries and Administrative Assistants 43-6010 19.39 19.39 38
(Clerical staff)...............................
Chief Executive................................. 11-1011 93.44 93.44 186
----------------------------------------------------------------------------------------------------------------
* Salary information used is for Nursing Care Facility/SNF industry. As indicated, we are adjusting our employee
hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe
benefits and overhead costs vary significantly from employer to employer, and because methods of estimating
these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe
that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

B. ICRs Regarding RNHCI Discharge Planning (Sec. 403.736(a) and (b))

Section 403.736 will reduce the extensive requirements for an RNHCI
to coordinate with other medical providers for post-RNHCI care. The
discharge evaluation must include an assessment of a patient's capacity
for self-care and information regarding the care once the patient
leaves the facility. The nursing staff would need to prepare the
patient and/or their caregiver for discharge. Most patients are
discharged to home or to another facility that adheres to the same
religious tenets. Although all patients must have a discharge planning
evaluation, not all patients require a discharge plan. Based on recent
claims data, there was a combined annual total of 619 beneficiaries
that stayed in the 18 facilities.
We estimate that the time currently required to develop and
document discharge plans and activities is 1,238 burden hours (2 hours
for each of the 619 beneficiaries discharged) and that it would be
reduced by half. Of the approximately 619 annual discharges, we
estimate that a RNHCIs burden would be reduced to one hour for each
discharged individual. A RNHCI would not need to develop a discharge
plan that includes medical care once a patient leaves the RNHCI because
doing so would not be in keeping with the religious tenets of the
patients they serve. We estimate that the healthcare support worker
responsible for a patients discharge plan is paid at mean wage of $36,
including 100 percent for fringe and overhead costs. Based on our
experience with RNHCIs, we estimate that it would take 1 hour to
develop the proposed discharge instructions and discuss them with the
patient and/or caregiver. We estimate a total of 619 annual discharges
from RNHCIs at a savings of $36 per discharge for a total savings of
$22,284 ($36 x 619 hours).

[[Page 47717]]

C. ICRs Regarding ASC Governing Body and Management (Sec.
416.41(b)(3)(i) and (ii))

We propose to eliminate the requirements at Sec. 416.41(b)(3) that
states the ASC must have a written transfer agreement with a hospital
or ensure all physicians performing surgery in the ASC have admitting
privileges at a local hospital that meets CMS hospitalization
requirements. All ASCs easily meet this requirement and have
established a relationship with their local hospital and obtained an
agreement as usual and customary practice for running an ASC with the
exception of approximately twenty ASCs that have difficult
relationships with their local hospitals. The savings would not be
significant, however, it does affect the 20 ASCs by removing the
requirement. The current information collection request for the ASC
rules (OMB control number 0938-1071) does not address any potential
burden associated with this requirement. We believe that having and
maintaining written agreements is standard practice. Therefore,
removing this requirement would not alter the current information
collection burden for ASCs.

D. ICR Regarding ASC Medical Records (Sec. 416.47(b)(2))

We propose to revise Sec. 416.47(b)(2) by adding the phrase ``(as
applicable)'' to the significant medical history and results of
physical examination requirement of documents that must be included in
the medical record in order to conform to the changes that we are
proposing to the mandatory medical history and physical examination
requirement. There are no collection of information requirements
associated with this proposed change because maintaining a medical
record for each patient is a usual and customary practice in accordance
with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).

E. ICRs Regarding ASC Patient Admission, Assessment and Discharge
(Sec. 416.52(a)(1), (2), (3) and (4))

At Sec. 416.52 we propose to replace the requirement that every
patient have a comprehensive medical history and physical examination
(H&P) within 30 days prior to surgery in an ASC with a requirement that
allows the operating physician and ASC to determine which patients
would require more extensive testing and assessment prior to surgery.
The burden associated with this requirement would be the time and
effort necessary to create new policies for when, and whether, to
require some form of history and physical that would require pre-
operative examination and testing, and on what time schedule. The
current information collection request for the ASC rules (OMB control
number 0938-1071) does not account for any information collection
related burden associated with the comprehensive H&P requirement. We
assume that creating these policies (which could leave such decisions
to the surgeon's discretion in most or all cases) would require 10
hours of physician time, 10 hours of RN time, and 10 hours of clerical
time, at the preceding hourly rates, for a total of 30 hours per
facility. This would be a one-time cost of $3,440 per facility ([10 x
$243] + [10 x $69] + [10 x $32]), and $19.1 million for all 5,557
facilities. Therefore, this proposed requirement would increase the
information collection related burden by $19.1 million and 166,710
hours (30 hours x 5,557 facilities) on a one-time basis for all ASCs.
The information collection request will be revised to account for the
additional burden.

F. ICRs Regarding Hospice Aide and Homemaker Services (Sec. 418.76)

At Sec. 418.76(a) we propose to defer to State training and
competency requirements, where they exist, for hospice aides. The
information collection request for the hospice requirements (OMB
control number 0938-1067) is currently under review at OMB. It
estimates that a hospice would spend 5 minutes per newly hired hospice
aide to document verification that an aide meets the required training
and competency requirements, for a total of 372 annual burden hours for
all hospices at a cost of $11,540. This proposed change to the actual
training and competency requirements would not alter the requirement to
document the fact that a hospice aide meets one of the training and
competency requirements set forth in the rule; therefore there would be
no change to the existing collection of information estimates because
the estimates relate to the unchanged documentation requirements rather
than the actual training and competency requirements that would be
revised by this proposed change.

G. ICRs Regarding Drugs and Biologicals, Medical Supplies, and Durable
Medical Equipment (Sec. 418.106(a) and (e)(2)(i))

At Sec. 418.106(a) we propose to remove the requirement that a
hospice ensure that the interdisciplinary group confers with an
individual with education and training in drug management as defined in
hospice policies and procedures and State law, who is an employee of or
under contract with the hospice to ensure that drugs and biologicals
meet each patient's needs. The information collection request for the
hospice requirements (OMB control number 0938-1067, currently under
review at OMB) states that the burden associated with this requirement
is the time necessary to document the results of this consultation in
each patient's clinical record. In the information collection request
we assumed that an average hospice would confer with a pharmacist, and
that the pharmacist would document the results of his/her consultation.
We estimated that it requires 5 minutes to document the initial review
of a patient's drug and biologicals. Additionally, we estimated that it
requires 5 minutes of the pharmacist's time to document a review of
updates to the patient's drug profile. Based on a 17 day median length
of service, we assumed that each patient would likely receive one
update to their plans of care. At an average hourly rate of $115 for a
pharmacist, we estimated that it would cost a hospice $19 per patient
($115 x [5 minutes for initial + 5 minutes for 1 update]) and an annual
cost of $6,764 ($19 x 356 patients). The total annual burden hours for
all hospices was estimated to be 264,588 hours (1,587,527 patients x
.1666 hour per patient), and the total annual burden cost for all
hospices was estimated to be $30,163,013 ($19 per patient x 1,587,527
patients). Therefore, removing the requirement that a hospice must
ensure that the interdisciplinary group confers with an individual with
education and training in drug management would result in a burden
reduction of 264,588 hours and $30,163,013.
We assume that, upon implementation of the proposed change to allow
hospices to provide information regarding the safe maintenance and
disposal of controlled drugs in a more user-friendly manner, hospices
would develop understandable instructions in layperson terms to replace
the copy of the policies and procedures that is currently provided.
While the instructions could be created in any number of formats, such
as a slide show, video, podcast, or pictograph, for purposes of our
analysis we assume that hospices would create written instructions. We
estimate that a hospice would use 1 hour of administrator time to
develop a new form at $105 per hour. For all 4,602 hospices, the total
initial cost would be $483,210.
The information collection request will be revised and sent to OMB.

[[Page 47718]]

H. ICRs Regarding Hospices That Provide Hospice Care to Residents of a
SNF/NF or ICF/IID (Sec. 418.112(c)(10) and (f))

At Sec. 418.112(f) we propose to allow hospices and long term care
facilities the additional flexibility to negotiate the format and
schedule for orienting long term care facility staff regarding certain
hospice-specific information. A hospice and SNF/NF or ICF/IID must have
a written agreement that specifies the provision of hospice services in
the facility. The agreement must be signed by authorized
representatives of the hospices and the SNF/NF or ICF/IID prior to the
provision of hospice care services. The burden associated with this
requirement is the time and effort necessary to develop, draft, sign,
and maintain the written agreement. As stated in the hospice
information collection request (OMB control number 0938-1067, currently
under review at OMB), the use of this type of written agreement is a
usual and customary business practice and the associated burden is
exempt from the PRA under the implementing regulations at 5 CFR
1320.3(b)(2). However, updating the written agreement to address this
new requirement would not constitute a usual and customary business
practice; therefore, we believe that a one-time burden to update the
written agreement would be imposed by this change. For purposes of this
analysis only, we estimate that each hospice would use 8 hours of
administrator time to revise the existing written agreement. At a cost
of $105 per hour for an administrator to complete this task, we
estimate that the onetime cost per hospice would be $840. For all
hospices the onetime cost would be $3,865,680 (4,602 hospices x $840)
for 36,816 hours (4,602 hospices x 8 hours). The information collection
request will be revised to account for this one time increase in burden
and sent to OMB.

I. ICRs Regarding Hospital Quality Assessment and Performance
Improvement (QAPI) Program (Sec. 482.21)

We propose a new standard at Sec. 482.21(f), ``Unified and
integrated QAPI program for multi-hospital systems''. We would allow
that for a hospital that is part of a hospital system consisting of two
or more separately certified hospitals subject to a system governing
body legally responsible for the conduct of each hospital, the system
governing body could elect to have a unified and integrated QAPI
program for all of its member hospitals after determining that such a
decision is in accordance with all applicable State and local laws. The
system governing body would be responsible and accountable for ensuring
that each of its separately certified hospitals meets all of the
requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that:
the unified and integrated QAPI program was established in a manner
that took into account each member hospital's unique circumstances and
any significant differences in patient populations and services offered
in each hospital; and the unified and integrated QAPI program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration, and
that the unified and integrated QAPI program has mechanisms in place to
ensure that issues localized to particular hospitals are duly
considered and addressed.
As stated in the information collection request for the hospital
requirements (OMB control number 0938-0328), which is in the process of
being reinstated, we estimate that the burden associated with updating
and, in some instances, writing new hospital policies directly related
to patient care would be an average of eight (8) hours annually for
each member of hospital staff involved in the specific patient care
policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,584
annually (8 burden hours x $198), a QAPI nurse coordinator at $552
annually (8 burden hours x $69), and a medical secretary at $272
annually (8 burden hours x $34).
We estimate the necessary policy changes needed to comply with the
requirements proposed in this rule would cost $2,408 per year ($1,584 +
$552 + $272) for each of the 424 hospital systems that would be
eligible to do so and that would choose to exercise this option.
Therefore, the total annual cost for all eligible hospital systems to
meet these information collection requirements would be approximately
$1 million.

J. ICRs Regarding Hospital Medical Staff, Medical Records Services, and
Surgical Services (Sec. Sec. 482.22, 482.24, and 482.51)

At Sec. 416.52 we propose to replace the requirement that every
patient have a comprehensive H&P within 30 days prior to surgery in an
ASC with a requirement that allows the operating physician and ASC to
determine which patients would require more extensive testing and
assessment prior to surgery. As discussed in ``Provisions of the
Proposed Regulations,'' section II.D.2 of this proposed rule, there is
a similar regulatory requirement for hospital outpatient surgery. Based
on the substantial similarity between these two service settings, we
propose, through the revisions to Sec. Sec. 482.22, 482.24, and 482.51
discussed in section II.D.2, to provide an exception to these
requirements for outpatient surgery in hospitals.
As stated in the information collection request for the hospital
requirements (OMB control number 0938-0328), which is in the process of
being reinstated, we estimate that the burden associated with updating
and, in some instances, writing new hospital policies directly related
to patient care would be an average of eight (8) hours annually for
each member of hospital staff involved in the specific patient care
policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,584
annually (8 burden hours x $198), a nurse coordinator at $552 annually
(8 burden hours x $69), and a medical secretary at $272 annually (8
burden hours x $34).
We estimate that the necessary policy changes needed to comply with
the requirements proposed in this rule would cost $2,408 per year
($1,584 + $552 + $272) for each of the 5,031 hospitals that might
choose to exercise this option. Therefore, the total annual cost for
all hospitals to meet these information collection requirements would
be approximately $12.1 million.

K. ICRs Regarding Hospital Medical Staff: Autopsies (Sec. 482.22)(d))

We propose to remove the requirement at Sec. 482.22(d), which
recommends that a hospital's medical staff attempt to secure autopsies
in all cases of unusual deaths and of medical-legal and educational
interest. Hospitals are further required to define a mechanism for
documenting permission to perform an autopsy, and they must have a
system for notifying the medical staff, and specifically the attending
practitioner, when an autopsy is being performed. Since more detailed,
specific requirements regarding medical-legal investigations and
autopsies for

[[Page 47719]]

hospitals are covered by the individual State laws in which the
hospital is located, there are no collection of information
requirements associated with this proposed change.

L. ICRs Regarding Hospital Infection Control (Sec. 482.42)

We propose a new standard at Sec. 482.42(c), ``Unified and
integrated infection control program for multi-hospital systems.'' Like
the proposed requirements for a unified and integrated QAPI program,
the proposed standard for infection control would allow that for a
hospital that is part of a hospital system consisting of multiple
separately certified hospitals subject to a system governing body
legally responsible for the conduct of each hospital, such system
governing body could elect to have a unified and integrated infection
control program for all of its member hospitals after determining that
such a decision was in accordance with all applicable State and local
laws. The system governing body would be responsible and accountable
for ensuring that each of its separately certified hospitals met all of
the requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that the
unified and integrated infection control program: (1) Was established
in a manner that took into account each member hospital's unique
circumstances and any significant differences in patient populations
and services offered in each hospital; (2) established and implemented
policies and procedures to ensure that the needs and concerns of each
of its separately certified hospitals, regardless of practice or
location, were given due consideration; (3) had mechanisms in place to
ensure that issues localized to particular hospitals were duly
considered and addressed; and (4) has designated a qualified
individual(s) with expertise in infection prevention and control at the
hospital to be responsible for communicating with the unified infection
control program, for implementing and maintaining the policies and
procedures governing infection control, and for providing infection
prevention education and training to hospital staff.
As stated in the information collection request for the hospital
requirements (OMB control number 0938-0328), which is in the process of
being reinstated, we estimate that the burden associated with updating
and, in some instances, writing new hospital policies directly related
to patient care would be an average of eight (8) hours annually for
each member of hospital staff involved in the specific patient care
policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,584
annually (8 burden hours x $198), an infection control nurse
coordinator at $552 annually (8 burden hours x $69), and a medical
secretary at $272 annually (8 burden hours x $34).
We estimate the necessary policy changes needed to comply with the
requirements proposed in this rule would cost $2,408 per year ($1,584 +
$552 + $288) for each of the 424 hospital systems that would be
eligible to do so and that would elect to exercise this option.
Therefore, the total annual cost for all eligible hospital systems to
meet these information collection requirements would be approximately
$1 million.

M. ICRs Regarding Special Requirements for Hospital Providers of Long-
Term Care Services (``Swing-Beds'') (Sec. 482.58(b)(1), (4), (5), and
(8), and Identical CAH requirements: Sec. 485.645(d)(1), (4), (5), and
(8))

At Sec. Sec. 482.58(b)(1) and 485.645(d)(1) (cross-referenced
long-term care requirement at Sec. 483.10(f)(9)) we propose to remove
the requirement for hospital and CAH swing-bed providers to provide the
right for patients to choose to or refuse to perform services for the
facility and if they so choose; (a) document in the resident's plan of
care, (b) noting whether the services are voluntary or paid and (c)
provide wages for the work being performed given the location quality,
and quantity of work requiring comparable skills. We believe this
requirement is unduly burdensome as we do not expect patient's
receiving hospital or CAH swing-bed services have an average length of
stay long enough to be positively impacted by providing services to the
facility. We assume that each of the hospital swing-bed providers (478
hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities
specialist employed at $40 per hour who would oversee the residents who
have chosen to perform services for the facility, and document and
update the plan of care accordingly. We believe that given the limited
budget of most rural providers, services are being provided to the CAH
on a voluntary basis and that these providers are not compensating
patients for providing these services. The current regulatory burden
for compliance with this requirement is approximately $29 million for
all hospital and CAH swing-bed providers, or $16,821 per hospital or
CAH swing-bed provider (1,724 hospital and CAH swing-bed providers x
$40 an hour for an activities specialist x 8 hours per week x 52 weeks
per year), which are the cost savings to the providers as a result of
the removal of this requirement.
At Sec. 482.58(b)(4) (and Sec. 485.645(d)(4)) (cross-referenced
long-term care requirement at Sec. 483.24(c)), we propose to remove
the requirement for hospital and CAH swing-bed providers to provide an
ongoing activity program that is directed by a qualified therapeutic
recreation specialist or an activities professional who meets certain
requirements as listed at Sec. 483.24(c)(2). We assume that each of
the hospital swing-bed providers (478 hospitals) and CAH swing-bed
providers (1,246 CAHs) has an activities specialist employed at least
part time at $40 per hour. CAHs are required to provide activity
services by either a qualified individual who meet the requirements of
Sec. 483.24(c)(2), or by an individual on the facility staff who is
designated as the activities director and who serves in consultation
with a therapeutic recreation specialist, occupational therapist, or
other professional with experience or education in recreational
therapy. For the purpose of this analysis, we assume that the cost of
each would be the same due to the rural location of CAHs. The current
regulatory burden for compliance with this requirement is based on the
activities specialist organizing, overseeing, and scheduling the
activity. The cost savings as a result of the removal of this
requirement are approximately $72 million for all hospital and CAH
swing-bed providers, or $41,800 per hospital or CAH swing-bed provider
(1,724 hospital and CAH swing-bed providers x $40 an hour for an
activities specialist x 1,040 hours per year) which are the cost
savings to the providers. Our analysis assumes that the reduced
staffing is largely for part-time work assignment (1,040 hours
annually) at hospital and CAH swing-bed providers. It is likely that
many of the actual persons holding these positions were full-time
workers not devoted solely to recreational therapy, whose hours will
simply be reassigned to other functions, with providers ultimately
saving these full-time equivalent hours through ripple effects on an
even wider range of staffing functions through turnover over time.
We propose to remove the requirement at Sec. Sec. 482.58(b)(5) and
485.645(d)(5) (cross-referenced long-

[[Page 47720]]

term care requirement at Sec. 483.70(p) for hospital and CAH swing-bed
providers to employ a qualified social worker on a full-time basis if
the facility has more than 120 beds. Given that this provision is not
applicable to either provider type due to the regulatory requirements
for each, it does not impose a burden upon hospitals and as such, its
removal would not result in a savings of economic burden hours or
dollars.
At Sec. Sec. 482.58(b)(8) and 485.645(d)(8) (cross-referenced
long-term care requirement at Sec. 483.55(a)(1)) we propose to remove
the requirement for hospital and CAH swing-bed providers to assist in
obtaining routine and 24-hour emergency dental care to its residents.
Under the current CoPs, hospitals and CAHs are currently required
to address the emergent dental care needs of their patients at Sec.
482.12(f)(2) for hospitals, and at Sec. 485.618 (emergency services)
for CAHs. As a result, we have calculated the burden associated with
the provision of routine dental care for hospital and swing-bed
patients. The American Dental Association recommends annual dental
checkups for routine dental care for adults over 60 years of age. With
an average length of stay in a hospital or CAH swing-bed of 1-2 weeks
and an average daily census of 2 patients, we assume that 1 patient
receiving swing-bed services will require routine dental services per
month. While a dentist and dental hygienist provide the dental
services, Medicare is billed for the provision of these services. The
costs to the provider are related to the nursing activities associated
with the patient receiving the dental services. The current regulatory
burden for compliance with this requirement is approximately $2.9
million for all hospital and CAH swing-bed providers, or $1,682 per
hospital or CAH swing-bed provider (1,724 hospital and CAH swing-bed
providers x $69 an hour for a RN x 24 hours per year), which are the
cost savings to the providers as a result of the removal of this
requirement. The information collection requests will be revised and
sent to OMB for approval (OMB control number 0938-0328 for hospitals
and 0938-1043 for CAHs).

N. ICRs Regarding Special Requirements for Psychiatric Hospitals (Sec.
482.61(d))

At Sec. 482.61(d) we propose to clarify the requirement allowing
non-physician practitioners to document progress notes in accordance
with State laws and scope of practice requirements. We believe this
would apportion the burden associated with having MDs/DOs document
their progress notes in psychiatric hospitals with non-physician
practitioners and will decrease costs associated with this activity. In
accordance with the information collection request for the hospital
requirements, which includes the special requirements for psychiatric
hospitals (OMB control number 0938-0328), no burden is associated with
recordkeeping, as the documentation and maintenance of medical records
is usual and customary. However, since we believe that clarification of
the intent of the regulation is necessary and will result in non-
physician practitioners (specifically physician assistants, nurse
practitioners, psychologists, and clinical nurse specialists)
documenting the progress notes for patients receiving services in
psychiatric hospitals, we are attributing ICR burden savings for this
provision. For purposes of this analysis only, we estimate that MDs/DOs
spend approximately 30 minutes documenting progress notes in
psychiatric hospitals. We estimate that 33 percent of this time would
be covered by non-physician practitioners. Of the 5,031 Medicare
participating hospitals, 574 (or 11 percent) are psychiatric hospitals.
According to AHA, there were 35,061,292 inpatient hospital stays in
2015, and an estimated 11 percent of these stays were at psychiatric
hospitals. The proposed change would result in a savings of $62.4
million (3,856,742 psychiatric hospital stays x 0.5 hours of physician/
psychiatrist time x $98 per hourly wage difference between physicians/
psychiatrists ($198) and non-physician practitioners ($100, the average
wage between nurse practitioners and physician assistants) x 33 percent
of physician time spent writing progress notes covered by non-physician
practitioners). This savings is equivalent to $108,647 per psychiatric
hospital per year.

O. ICRs Regarding Special Requirement for Transplant Centers and
Definitions (Sec. Sec. 482.68 and 482.70)

We are proposing a nomenclature change at part 482 and the
transplant center regulations at Sec. Sec. 482.68, 482.70, 482.72
through 482.104, and at Sec. 488.61. Because this change would update
the terminology used in the regulations to conform to the terminology
that is widely used and understood within the transplant community,
there are no collection of information requirements associated with
this proposal.

P. ICRs Regarding Data Submission, Clinical Experience, and Outcome
Requirements for Re-Approval of Transplant Centers (Sec. 482.82)

Section 482.82 requires that, except as specified in Sec. 488.61,
transplant centers must meet all the data submission, clinical
experience, and outcome requirements to be re-approved for Medicare
participation. Section 482.82(a) requires that no later than 90 days
after the due date established by the OPTN, a transplant center must
submit to the OPTN at least 95 percent of the required data submissions
on all transplants (deceased and living donors) it has performed over
the 3 year approval period. The required data submissions include, but
are not limited to, submission of the appropriate OPTN forms for
transplant candidate registration, transplant recipient registration
and follow up, and living donor registration and follow up.
Furthermore, Sec. 482.82(b) requires transplant centers to perform an
average of 10 transplants per year during the prior 3 years and Sec.
482.82(c) requires transplant centers to meet the outcome requirements
for Medicare re-approval. The burden associated with this requirement
would be the time it would take a transplant program to submit the
required information. However, as required by Sec. Sec. 482.72 and
482.45(b), a hospital in which a transplant program is located, must
belong to the OPTN, and the OPTN requires that these hospitals submit
this data to the OPTN. Therefore, we believe that the requirements
under Sec. 482.82 do not impose an additional burden on transplant
programs because all Medicare participating transplant programs are
already submitting this information to the OPTN. Removing these
requirements will have no additional collection of information burden
on transplant programs. We describe additional life-saving benefits
that result from the removal of this proposal in the subsequent RIA
section.

Q. ICRs Regarding Special Procedures for Approval and Re-Approval of
Organ Transplant Centers (Sec. 488.61(f) Through (h))

Section 488.61(f) through (h) sets out the process for our
consideration of a transplant center's mitigating factors in initial
approval and re-approval surveys, certifications, and enforcement
actions for transplant centers. The provisions also set out definitions
and rules for transplant systems improvement agreements. We are
proposing to remove the requirements at Sec. 488.61(f) through (h) for
mitigating

[[Page 47721]]

factors and transplant systems improvement agreements for the re-
approval process for transplant centers. This change is complementary
to the proposed removal of Sec. 482.82, described previously. The
information collection request (OMB Control Number 0938-1069) does not
account for any information collection related burden associated with
the requirements in Sec. 488.61(f) through (h) for the re-approval
process. Therefore, we estimate that the requirements under Sec.
488.61(f) would require a transplant program to write and submit the
initial formal notice of the program's intent to seek mitigating
factors re-approval, and write and submit a request for consideration
of mitigating factors (which would include all of the content listed in
Sec. 488.61(f)(2)). We estimate that this would take a medical
director, a transplant center senior administrator, and a hospital
administrator approximately 5 hours, or 2 hours for the medical
director and the transplant program senior administrator and 1 hour for
the hospital administrator, to complete and submit these mitigating
factors for re-approval, as described in Table 2.

Table 2--Annual Burden Hours and Cost for Transplant Programs To Submit Mitigating Factors for Re-approval
----------------------------------------------------------------------------------------------------------------
Total cost
Position Hourly wage Hours required estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................ $194 2 $388
Transplant Program Senior Administrator......................... 105 2 210
Hospital Administrator.......................................... 105 1 105
-----------------------------------------------
Totals...................................................... .............. 5 703
----------------------------------------------------------------------------------------------------------------

In total, we estimate that an average of 14 programs would submit
mitigating factors annually. Thus, for those 14 programs we estimate
that it would require 70 burden hours (5 burden hours x 14 programs) at
a cost of $9,842 ($703 x 14 programs). In the context of this proposed
rule, removing this requirement would yield an estimated savings to
transplant programs of 5 burden hours each and a total of 70 burden
hours for all 14 programs, with a total cost savings of $9,842.
In addition, we estimate that the transplant hospital in
conjunction with the transplant program that is located in the
hospital, would submit mitigating factors and then would also enter
into systems improvement agreements, as described under Sec. 488.61(h)
annually. This would require the hospital to enter into a binding
agreement with CMS to allow the program additional time to achieve
compliance with the CoPs. The agreement would require hospitals to
complete certain tasks as listed and described in Sec. 488.61(h)(1),
which include (but are not limited to): Patient notification about the
degree and type of noncompliance by the program, an explanation of what
the program improvement efforts mean for patients and financial
assistance to defray the out-of-pocket costs of copayments and testing
expenses for any wait-listed individual who wishes to be listed with
another program, an external independent peer review team that conducts
an onsite assessment of the program, an action plan that addresses
systemic quality improvements and is updated after the onsite peer
review, an onsite consultant who provides services for 8 days per month
on average for the duration of the agreement, a comparative
effectiveness analysis that compares policies, procedures, and
protocols of the transplant program with those of other programs in
areas of endeavor that are relevant to the center's current quality
improvement needs, amongst other requirements listed in Sec.
488.61(h)(1)(i) through (x). We estimate that this would take a medical
director, a transplant program senior administrator, a hospital
administrator, and an administrative assistant approximately 14 hours,
or 4 hours for the medical director, transplant program senior
administrator, and an administrative assistant, and 2 hours for the
hospital administrator to complete these activities (including
notifying patients about the degree of noncompliance by mail and
organizing and completing the other tasks listed in Sec. 488.61(h)(1)
as required by the terms in the systems improvement agreement), as
described in Table 3.

Table 3--Annual Burden Hours and Cost for Transplant Programs To Enter Into a Systems Improvement Agreement for
Re-Approval
----------------------------------------------------------------------------------------------------------------
Total cost
Position Hourly wage Hours required estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................ $194 4 $776
Transplant Program Senior Administrator......................... 105 4 420
Hospital Administrator.......................................... 105 2 210
Administrative Assistant........................................ 34 4 136
-----------------------------------------------
Totals...................................................... .............. 14 1,542
----------------------------------------------------------------------------------------------------------------

In total, we estimate that an average of 14 programs will submit
mitigating factors annually. Thus, for those 14 programs we estimate
that it would require 196 burden hours (14 burden hours x 14 programs)
at a cost of $21,588 ($1,542 x 14 transplant programs). In the context
of this proposed rule, removing this requirement would yield an
estimated savings to transplant programs of 14 burden hours each and a
total of 196 burden hours for all 14 programs, with a total cost
savings of $21,588.

R. ICRs Regarding HHA Home Health Aide Services (Sec. 484.80(h)(3))

We propose to eliminate the requirement at Sec. 484.80(h)(3) that
the HHA conduct a full competency evaluation of deficient home health

[[Page 47722]]

aides, and replace it with a requirement to retrain the aide regarding
the identified deficient skill(s) and require the aide to complete a
competency evaluation related only to those skills. The content of an
aide competency examination does not have an associated collection of
information requirement. Therefore, this proposed change would neither
impose nor remove any collection of information burdens.

S. ICRs Regarding HHA Clinical Records (Sec. 484.110(e))

We propose to remove the requirement at Sec. 484.110(e) related to
providing a requested copy of information contained in the clinical
record at the next home visit, while retaining the requirement to
provide the record within 4 business days. As stated in the January
2017 HHA CoP final rule (82 FR 4568 and 4575), we believe that
providing such information to patients is a usual and customary
practice that does not impose a burden upon HHAs and would not be
subject to the PRA in accordance with the implementing regulations of
the PRA at 5 CFR 1320.3(b)(2). As such, removing the ``next home
visit'' timeframe requirement would not result in a savings of burden
hours or dollars.

T. ICRs Regarding CORF Utilization Review Plan (Sec. 485.66)

We propose to reduce the required frequency in which CORFs would be
required to complete a ``utilization review plan'' from quarterly to
annually. Changing from a quarterly implementation of the utilization
review plan to an annual implementation would reduce the current
documentation requirements (OMB control number 0938-1091) on CORFs by
75 percent each year. For the purposes of our analysis, we estimate
that it would take a CORF approximately 8 hours for administrative,
clinical and clerical staff to review and evaluate the necessary and
efficient use of services provided by the facility on a quarterly
basis, for a total of 32 hours per year per CORF and 6,016 hours for
all 188 CORFs. In a 1-year period, we estimate a savings of $1,644 per
facility ($548 x 3 quarters), and a combined total savings of $309,072
for all CORFs ($1644 x 188 CORFs). We will submit the revised
information collection request to OMB for approval.

Table 4--CORF--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly wage Burden hours Cost estimate
Position per CORF * per CORF per CORF
----------------------------------------------------------------------------------------------------------------
Administrator................................................... $105 2 $210
Clerical Staff.................................................. 32 2 64
Physical Therapist.............................................. 84 2 168
Social Worker................................................... 53 2 106
-----------------------------------------------
Total....................................................... 274 8 548
----------------------------------------------------------------------------------------------------------------
* Includes 100% fringe benefits & overhead costs.

U. ICRs Regarding CAH Organizational Structure (Sec. 485.627(b)(1))

As of May 2017, there were 1,343 CAHs that are certified by
Medicare. Our proposed revision of the CAH disclosure requirements
imposed on CAHs would remove the requirement for CAHs to disclose to
CMS its owners, or those with a controlling interest in the CAH or in
any subcontractor in which the CAH directly or indirectly has a 5
percent or more ownership interest, in accordance with 42 CFR part 420,
subpart C. While we estimate that these changes occur at 2 CAHs per
year on average between all 1,343 CAHs, with the vast majority not
experiencing any such changes throughout the lifetime of the CAH, each
CAH is still required to review the duplicative documentation. In
accordance with Medicare Program; Criteria and Standards for Evaluating
Regional Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS); Final Rule and Request for Comments (57 FR 2790, June 18,
1992), the burden associated with this requirement is 1-hour per
facility. As a result, this proposal will save all CAHs an estimated
$141,000 and will save each CAH $105 (1-burden hour for an
administrator at $105 per hour x 1,343 CAHs). We will submit the
revised information collection request to OMB for approval (OMB control
number 0938-0328).

V. ICRs Regarding CAH Provision of Services (Sec. 485.635(a)(4))

Section 485.635(a)(4) requires CAHs to conduct an annual review of
all its policies and procedures. Based on feedback from stakeholders,
the prescriptive annual schedule is burdensome or, in some situations,
ineffective. Our proposed revision of the patient care policies
requirements imposed on CAHs would reduce the frequency that is
currently required for CAHs to perform a review of all their policies
and procedures. We propose that a change from an annual review to a
biennial review would reduce the burden on CAHs by half in a given
period of time. For the purposes of our analysis, we estimate that it
would take a CAH approximately 16 hours for administrative and clinical
staff to review and make changes to policies and procedures annually.
In a 2-year period, we estimate a savings of $1,956.10 per facility,
and a combined total savings of $2.6 million for CAHs ($1,956.10 x
1,343 CAHs).
We estimate that the CAH staff time and associated costs would be
assigned to a biennial review as shown in Table 5.

Table 5--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly wage Burden hours Cost estimate
Position per CAH per CAH per CAH
----------------------------------------------------------------------------------------------------------------
Administrator................................................... $186.88 4 $747.52
Clerical staff.................................................. 38.78 3 116.34
Registered Nurse................................................ 69.40 3 208.20

[[Page 47723]]

Nurse practitioner.............................................. 100.60 3 301.80
Physician....................................................... 194.08 3 582.24
-----------------------------------------------
Totals...................................................... 589.74 16 1,956.10
----------------------------------------------------------------------------------------------------------------

W. ICRs Regarding Special Requirements for CAH Providers of Long-Term
Care Services (``Swing-Beds'') (Sec. 485.645(d)(1), (4), (5) and (8))

We have included the discussion of the ICRs regarding special
requirements for CAH providers of long-term care services in the
discussion of the ICRs regarding special requirements for hospital
providers of long-term care services which can be found under section L
of this part.

X. ICRs Regarding CMHCs (Sec. 485.914(d))

Section 485.914(d)(1) requires each CMHC to update each client's
comprehensive assessment via the CMHC interdisciplinary treatment team,
in consultation with the client's primary health care provider (if
any), no less frequently than every 30 days. We propose to modify the
requirement at Sec. 485.914(d) to remove the 30-day assessment update
time frame for those clients who do not receive PHP services. Instead
of a fixed 30-day time frame, assessment updates would be completed
when changes in the client's status, responses to treatment, or goal
achievement have occurred, and in accordance with current standards of
practice. The burden associated with these requirements is the time
required to record an updated assessment. The current information
collection request (OMB Control number 0938-1245) does not account for
any information collected related to the burden associated with
updating the comprehensive assessment requirement. While in the past we
believed that this is considered usual and customary practice, recent
comments from the CMHC provider community, submitted in response to
CMS' solicitation for public comments pertaining to burden reduction
suggestions, stated that it is not usual and customary to update
assessments for non-PHP clients on a 30 day schedule as required by the
CMHC regulations. The commenters stated that the 30 day requirement was
overly burdensome, and suggested that the CMHC assessment update
requirement should more closely align with the patient-oriented
approach of other entities that govern CMHC operations. Upon further
consideration, we agreed with the commenter that the 30 day requirement
does, in fact, impose a burden and is not usual and customary practice.
Therefore, removing this requirement would reduce information
collection burden for CMHCs.
Under the current 30-day time frame requirement, each client
receives an updated assessment 12 times per year. We estimate that, in
accordance with the proposed need-based assessment update requirements,
each non-PHP client would receive 2 assessment updates in a year.
Therefore, we estimate that this change would reduce the burden of 10
assessments per client, per year.
As of August 2017 there are 52 Medicare participating CMHCs serving
3,122 Medicare beneficiaries and an estimated 2,080 non-Medicare
clients, for an average of 100 clients per CMHC. In order to develop
the estimated number of non-Medicare clients we divided the total
number of Medicare beneficiaries who received partial hospitalization
services by the total number of Medicare-participating CMHCs to
establish the average number of Medicare beneficiaries per CMHC. This
resulted in 60 beneficiaries per CMHC. We then assumed that, in order
to comply with the 40 percent requirement (Sec. 485.918(b)(1)(v)),
those 60 beneficiaries only accounted for 60 percent of an average
CMHC's total patient population. This means that an average CMHC also
treated another 40 clients who did not have Medicare as a payer source,
for a total of 100 clients (Medicare + non-Medicare) in an average
CMHC. Therefore, all CMHCs combined would have approximately 2,080 non-
PHP clients per year (40 per CMHC), and approximately 20,800
assessments would be reduced nationwide per year (2,080 patients x 10
assessments per patient). We estimate that documenting each assessment
update requires 10 minutes of a CMHC clinician's time, for a total
savings of 3,466 hours nationwide (1,666 hours x 20,800 assessment
updates). At a cost of $7.33 for a mental health counselor to document
each assessment, the total cost savings would be $152,464 ($7.33 x
20,800 assessments).

Y. ICRs Regarding Portable X-Ray Services (Sec. Sec. 486.104(a) and
486.106(a))

We propose to revise the requirements for portable x-ray
technologist personnel qualifications at Sec. 486.104 to align the
current requirements at Sec. 486.104(a)(1), (2), (3), and (4) with
those for hospital radiologic technologists at Sec. 482.26(c)(2) which
are focused on the qualifications of the individual performing services
as permitted by State law. Although changing the qualifications would
require management time, with the associated cost of those hours, in
order to revise the internal personnel descriptions and qualifications,
we believe that this proposed change would impose no burden because
maintaining internal personnel descriptions and qualifications is a
standard business practice. Therefore, this burden would not be subject
to the PRA in accordance with the implementing regulations of the PRA
at 5 CFR 1320.3(b)(2).
We propose to revise the requirements for portable x-ray orders at
Sec. 486.106(a)(2). We propose to remove the requirement that
physician or non-physician practitioner's orders for portable x-ray
services must be written and signed. We also propose to replace the
specific requirements related to the content of each portable x-ray
order with a cross-reference to the requirements at 42 CFR 410.32,
which also apply to portable x-ray services. These proposed changes
would simplify the ordering process for portable x-rays and promote the
use of more efficient ordering methods, such as electronic orders.
This change would allow for portable x-ray services to be ordered
in writing, by telephone, or by electronic methods. The change would
also streamline the ordering process by avoiding the need to write two
separate orders for the same study, one to meet the Medicare payment
requirements in accordance with Sec. 410.32 and its associated Manual
guidance, and another to meet the content requirements of the
regulation set forth at Sec. 486.106. We believe the proposed change
would allow for additional ordering flexibility to streamline ordering
practices. In the information collection request (OMB control number
0938-0338) we estimate

[[Page 47724]]

that the current order requirements would impose the following burdens:
3 minutes to write an order x 3,986,000 portable x-rays
exams ordered = 199,300 hours x $69/hour for a nurse = $13,751,700.
$1 for printing and faxing verbal orders to physician
offices for signature x 2,500,000 verbal orders = $2,500,000.
2,000,000 follow-up calls regarding the status of faxes x
10 minutes of time for clerical staff (5 minutes for portable x-ray
clerical staff + 5 minutes for ordering physician clerical staff) =
333,333 hours x $32/hour = $10,666,656.
All of these burdens would be eliminated by revising the current
ordering standards. Therefore, we estimate a proposed information
collection savings of $26,918,356 from this proposed change.

Z. ICRs Regarding RHC and FQHC Provision of Services (Sec.
491.9(b)(4))

There are currently more than 4,100 RHCs and approximately 1,400
FQHC organizations furnishing services at approximately 12,000 or more
total locations. Many FQHC organizations have multiple delivery sites,
so to be as accurate as possible, our burden reduction calculations are
based on the most recent data available, which shows that as of May
2017, there were 4,160 RHCs and 7,874 FQHC delivery sites. All CMS-
certified sites are subject to our requirements and we are therefore
utilizing the total number of current sites in our burden reduction
calculations.
We propose to revise Sec. 491.9(b)(4) to reduce the number of
times that RHCs and FQHCs perform a review of all their policies and
procedures. Changing from an annual review to a review every other year
would reduce the burden on RHCs and FQHCs by half in a given period of
time. In the currently approved information collection request (OMB
control number 0938-0334), we estimate that it would take a RHC or FQHC
approximately 4 hours for clinical staff to review and make changes to
policies and procedures annually, for a total of 48,136 hours for all
12,034 RHC and FQHC locations. In a 2-year period, RHCs and FQHCs would
use 96,272 total hours to comply with the requirements to annually
review all of their policies and procedures. Under the proposed change
to a review every other year, we estimate that in a 2-year period, it
will take a total of 48,136 hours, for a savings of 48,136 hours per
year. We estimate a savings of $592 per facility (see Table 6) for a
combined total savings of $7.1 million for 12,034 RHCs or FQHCs ($592 x
12,034 RHCs and FQHCs). We will submit a revised information collection
request to OMB for approval.

Table 6--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly wage
per RHC/FQHC
Position (Includes 100% Burden hours Cost estimate
benefit per RHC/FQHC per RHC/FQHC
package)
----------------------------------------------------------------------------------------------------------------
Physician....................................................... $198 2 $396
Mid-Level Provider (PA or NP)................................... 98 2 196
-----------------------------------------------
Total....................................................... 296 4 592
----------------------------------------------------------------------------------------------------------------

AA. ICRs Regarding RHC and FQHC Program Evaluation (Sec. 491.11(a))

We propose to revise Sec. 491.11(a) to reduce the number of times
that RHCs and FQHCs carry out or arrange for an annual evaluation of
the total program. Changing from an annual evaluation to an evaluation
every other year would reduce the burden on RHCs and FQHCs by half in a
given period of time. In the currently approved information collection
request (OMB control number 0938-0334), we estimate that it would take
a RHC or FQHC approximately 6 hours for administrative and clinical
staff to perform an evaluation of its total program annually for a
total of 72,204 hours for all 12,034 RHC and FQHC locations. In a 2-
year period, RHCs and FQHCs would use 144,408 total hours to comply
with the requirement for an evaluation of the total program. Under the
proposed change to evaluate the total program every other year, we
estimate a hourly savings of 72,204 total hours and a cost savings of
$802 per facility (see Table 7), for a combined total savings of $9.7
million for 12,034 RHCs or FQHCs ($802 x 12,034 RHC and FQHC
locations).

Table 7--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly wage
per RHC/FQHC
Position (Includes 100% Burden hours Cost estimate
benefit per RHC/FQHC per RHC/FQHC
package)
----------------------------------------------------------------------------------------------------------------
Administrator/Health Services Manager........................... $105 2 $210
Physician....................................................... 198 2 396
Mid-Level Provider (PA or NP)................................... 98 2 196.00
-----------------------------------------------
Total....................................................... 401 6 802
----------------------------------------------------------------------------------------------------------------

[[Page 47725]]

BB. ICRs Regarding Emergency Preparedness for Providers and Suppliers

1. Review of the Emergency Preparedness Program
At Sec. 482.15(a), (b), (c), and (d) for hospitals and parallel
regulatory citations for other facilities, we propose to allow
providers to review their program at least every 2 years. As of May
2017, there were approximately 74,246 total facilities. All are
required to review their emergency preparedness program annually, which
includes a review of their emergency plan, policies and procedures,
communication plan, and training and testing program.
For our analysis, we estimate that reducing this requirement from
annually to biennially would reduce compliance costs related to review
of the emergency plan by 50 percent. The methodology used for our cost
estimate analysis generally mirrors the methodology used for the annual
review of the emergency plan Emergency Preparedness final rule (81 FR
63930) with a 50 percent reduction in the cost estimate calculation;
however, after receiving additional feedback from stakeholders, we have
determined that we underestimated the amount of time it would take to
review the emergency plan. As a result, we have presented current
burden hours associated with reviewing the emergency plan that reflects
the increased associated burden hours relative to the information
collection request for this provision (OMB control number 0938-1325).
As in the Emergency Preparedness final rule (81 FR 63930), we assume
that the individuals involved in the review of the emergency plan
include an administrator, director of nursing, a RN, a physician, a
social worker, a counselor, and an office manager, depending on the
facility type. Based on May 2016 BLS salary data, we calculated the
hourly mean wage for each position for this requirement identified in
the Emergency Preparedness final rule (81 FR 63930).
We estimate that the proposed change will accrue a total annual
cost savings of $94,312,719 and 187 burden hours saved. We list a
detailed calculation for each facility below, based on facility numbers
available as of May 2017:
RNHCIs: Combined total savings of $9,540 for 18 RNHCIs ((8
burden hours for an administrator at $105 plus 5 burden hours for a
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
ASCs: Combined total savings of $6,134,928 for 5,557 ASCs
((8 burden hours for an administrator at $108 per hour plus 4 burden
hours for a physician at $198 per hour plus 8 burden hours for a
quality improvement RN at $69 per hour) x 5,557 ASCs x 50 percent).
Hospices: Combined total savings of $5,781,832 for 4,489
hospice facilities ((8 burden hours for an administrator at an hourly
wage of $105 per hour plus 4 burden hours for a physician at $198 per
hour plus 4 burden hours for a counselor at $44 per hour plus 4 burden
hours for a social worker at $54 per hour plus 8 burden hours for a RN
at $69 per hour) x 4,489 hospices x 50 percent).
PRTFs: Combined total savings of $556,512 for 374 PRTFs
((8 burden hours for an administrator $105 per our plus 8 burden hours
for a physician at $198 per hour plus 8 burden hours for a RN at $69
per hour) x 374 PRTFs x 50 percent).
PACE: Combined total savings of $226,476 for 233 PACE
organizations ((8 burden hours for an administrator at $105 per hour
plus 8 burden hours for a home care coordinator at $69 per hour plus 8
burden hours for a RN at $69 per hour) x 233 PACE organizations x 50
percent).
Hospitals: Combined total savings of $11,933,532 for 5,031
hospitals ((8 burden hours for an administrator at $108 per hour plus 8
burden hours for a physician at $198 per hour plus 8 burden hours for a
risk management director at $105 per hour plus 8 burden hours for a
quality assurance nurse at $69 per hour plus 8 burden hours for a
facility director at $96 per hour plus 4 burden hours for a medical
secretary at $34 per hour) x 5,031 hospitals x 50 percent).
LTCF: Combined total savings of $25,562,016 for 15,663
LTCF facilities ((8 burden hours for an administrator at $105 per hour
plus 8 burden hours for a physician at $198 per hour plus 8 burden
hours for a director of nursing at $105 per hour) x 15,663 LTCFs x 50
percent).
ICF/IID: Combined total savings $3,402,126 for 6,097 ICF/
IIDs ((8 burden hours for an administrator at $105 per hour plus 4
burden hours for a RN $69 per hour) x 6,097 ICF/IIDs x 50 percent).
HHA: Combined total savings of $16,259,712 for 12,624 HHAs
((8 burden hours for an administrator at $105 per hour plus 8 burden
hours for a nursing director at $105 per hour plus 8 burden hours for a
director of rehab at $84 per hour plus 4 burden hours for an office
manager at $56 per hour) x 12,624 HHAs x 50 percent).
CORF: Combined total savings of $142,128 for 188 CORFs ((8
burden hours for an administrator at $105 per hour plus 8 burden hours
for a physical therapist at $84 per hour) x 188 CORFs x 50 percent).
CAH: Combined total savings of $1,643,832 for 1,343 CAHs
((8 burden hours for an administrator at $105 per hour plus 8 burden
hours for a director of nursing at $105 per hour plus 8 burden hours
for a facility director at $96 per hour) x 1,343 CAHs x 50 percent).
Organizations: Combined total savings of $1,220,688 for
2,076 Organizations ((8 burden hours for an administrator at $105 per
hour plus 4 burden hours for a physical therapist at $84 per hour) x
2,076 Organizations x 50 percent).
CMHCs: Combined total savings of $146,832 for 161 CMHCs
((8 burden hours for an administrator at $105 per hour plus 8 burden
hours for a RN at $69 per hour plus 8 burden hours for a social worker
at $54 per hour) x 161 CMHCs x 50 percent).
OPOs: Combined total savings of $119,016 for 58 OPOs ((8
burden hours for an OPO director at $105 per hour plus 8 burden hours
for a physician at $198 per hour plus 8 burden hours for a QAPI
director at $105 per hour plus 8 burden hours for an organ procurement
coordinator at $105 per hour) x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $9,916,016 ((8 burden
hours for an administrator at $105 per hour plus 8 burden hours for a
nurse practitioner/physician assistant at $101 per hour) x 4,160 RHCs x
50 percent) $3,427,840 + ((8 burden hours for an administrator at $105
per hour plus 8 burden hours for a nurse practitioner/physician
assistant at $101 per hour x 7,874 FQHCs x 50 percent) $6,488,176).
ESRD Facilities: Combined total savings of $11,064,392 for
6,898 dialysis facilities ((8 burden hours for an administrator at $105
per hour plus 8 burden hour for a medical director/physician at $198
per hour plus 8 burden hours for a nurse manager at $105) x 6,898
dialysis facilities x 50 percent) as shown in Table 8.

[[Page 47726]]

Table 8--Cost Savings for Annual Review of Emergency Preparedness Plan
------------------------------------------------------------------------
Cost savings
Provider/supplier per provider/ Combined total savings
supplier
------------------------------------------------------------------------
RNHCIs......................... $530 $9,540 for 18 RNHCIs.
ASCs........................... 1,104 $6,134,928 for 5,557
ASCs.
Hospices....................... 1,288 $5,781,832 for 4,489
hospice facilities
both inpatient and
freestanding/home
based.
PRTFs.......................... 1,488 $556,512 for 374 PRTFs.
PACEs.......................... 972 $226,476 for 233 PACEs.
Hospitals...................... 2,372 $11,933,532 for 5,031
hospitals.
LTCFs.......................... 1,632 $25,562,016 for 15,663
LTCFs.
ICFs/IIDs...................... 558 $3,402,126 for 6,097
ICF/IIDs.
HHAs........................... 1,288 $16,259,712 for 12,624
HHAs.
CORFs.......................... 756 $142,128 for 188 CORFs.
CAHs........................... 1,224 $1,643,832 for 1,343
CAHs.
Organizations.................. 588 $1,220,688 for 2,076
Organizations.
CMHCs.......................... 912 $146,832 for 161 CMHCs.
OPOs........................... 2,052 $119,016 for 58 OPOs.
RHCs/FQHCs..................... 824 $9,916,016 for RHCs and
FQHCs ($3,427,840 for
4,160 RHCs and
$6,488,176 for 7,874
FQHCs).
ESRD Facilities................ 1,6332 $11,257,536 for 6,898
dialysis facilities.
------------------------------------------------------------------------

2. Contents of the Emergency Plan
At Sec. 482.15(a)(4) for hospitals, and other parallel citations
for the facilities mentioned in section II.J.2 of this proposed rule,
we propose to eliminate the requirement that facilities document
efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials and that facilities document
participation in collaborative and cooperative planning efforts. We
estimate that an administrator, or in the case of a hospital a
community relations manager, a program director for a PACE, or a QAPI
director for OPOs, would take 1 hour to document efforts to contact
local, tribal, regional, State and Federal emergency preparedness
officials and, when applicable, document the facility's participation
in collaborative and cooperative planning efforts. We note that the
Joint Commission (TJC)-accredited ASCs, TJC-accredited CAHs, and TJC-
accredited hospitals have emergency preparedness requirements for
developing an emergency preparedness plan that are comparable to the
current emergency preparedness CoPs (81 FR 63937, 63954, and 63978
through 63979). Utilizing the same assumptions we used in the Emergency
Preparedness final rule (81 FR 63937, 63954, and 63978 through 63979),
we estimate that cost savings will accumulate from non-TJC accredited
ASC, CAHs, and hospitals, since TJC-accredited ASCs, CAHs and hospitals
are already required by the TJC to develop emergency preparedness
plans. As a result, these facilities are excluded from the analysis
given the requirements of their accreditation organization standards.
Based on May 2016 BLS salary data, we calculate an hourly mean wage of
$105 for an administrator, a PACE Program Director, or QAPI director
and a cost savings of $105 per facility for RNHCIs, non-TJC accredited
ASCs, hospices (both inpatient and freestanding), PRTFs, PACEs, LTCFs,
ICF/IIDs, HHAs, CORFs, non-TJC accredited CAHs, Organizations, CMHCs,
OPOs, RHC/FQHCs, and dialysis facilities ($105 hourly mean wage x 1
burden hour). For non-TJC accredited hospitals, we estimate an hourly
mean wage of $114 for a community relations manager, and a $114 cost
per facility ($114 x 1 hour). Therefore, we estimate the following for
each facility affected by the proposed change, for a total savings of
$7,179,117 and 18 burden hours. We list a summary of the calculation
for savings accrued by removing this requirement for each facility in
Table 9, based on facility numbers available as of May 2017.

Table 9--Cost Savings: Documentation of the Facility's Participation in
Collaborative and Cooperative Planning Efforts
------------------------------------------------------------------------
Cost savings
Provider/supplier per provider/ Combined total savings
supplier
------------------------------------------------------------------------
RNHCIs......................... $105 $1,890 for 18 RNHCIs.
ASCs (Non-TJC accredited)...... 105 $522,375 for 4,975 non-
TJC accredited ASCs.
Hospices....................... 105 $471,345 for 4,489
hospice facilities
both inpatient and
freestanding/home
based.
PRTFs.......................... 105 $39,270 for 374 PRTFs.
PACEs.......................... 105 $24,465 for 233 PACEs.
Hospitals (Non-TJC accredited). 114 $157,662 for 1,383 non-
TJC accredited
hospitals.
LTCFs.......................... 105 $1,644,615 for 15,663
LTCFs.
ICFs/IIDs...................... 105 $640,185 for 6,097 ICF/
IIDs.
HHAs........................... 105 $1,325,520 for 12,624
HHAs.
CORFs.......................... 105 $19,740 for 188 CORFs.
CAHs (Non-TJC accredited)...... 105 $103,215 for 983 non-
TJC accredited CAHs.
Organizations.................. 105 $217,980 for 2,076
Organizations.
CMHCs.......................... 105 $16,905 for 161 CMHCs.
OPOs........................... 105 6,090 for 58 OPOs.
RHCs/FQHCs..................... 105 $1,263,570 for RHCs and
FQHCs ($436,800 for
4,160 RHCs and
$826,770 for 7,874
FQHCs).

[[Page 47727]]

ESRD Facilities................ 105 $724,290 for 6,898
dialysis facilities.
------------------------------------------------------------------------

3. Training
At Sec. 482.15(d)(1)(ii) for hospitals, and other parallel
citations for other facilities mentioned in section II.J.2 of this
proposed rule, we propose to require that facilities provide training
biennially, or every 2 years, after facilities conduct initial training
on their emergency program. In addition, we propose to require
additional training when the emergency plan is significantly updated.
We believe that the annual training requirement is too prescriptive as
annual may not always be necessary. We propose to maintain the
requirement that providers and suppliers develop a well-organized,
effective training program that includes initial training for new and
existing staff in emergency preparedness policies and procedures and
would require training when the emergency plan is significantly
updated. Facilities would have the flexibility to determine what is
considered a significant update to the emergency plan.
For our analysis, we estimate that reducing this requirement from
annually to biennially will reduce compliance costs related to
providing emergency preparedness training by 50 percent. The
methodology used for our cost estimate analysis mirrors the methodology
used for the annual training requirement in the Emergency Preparedness
final rule (81 FR 63930) with a 50 percent reduction in the cost
estimate calculation. As in the Emergency Preparedness final rule (81
FR 63930), we assume that the individuals involved in the development
and provision of training include an administrator, director of
nursing, a RN, and an office manager, depending on the facility type.
Providers and suppliers are expected to provide initial training in
emergency preparedness policies and procedures to all new and existing
staff, individuals providing services under arrangement, and
volunteers, consistent with their expected roles, and maintain
documentation of the training. Based on May 2016 BLS salary data, we
calculated the hourly mean wage for each position for this requirement
identified in the Emergency Preparedness final rule (81 FR 63930). We
estimate that the proposed change will accrue a total annual cost
savings of $33,267,864 and 111 burden hours. We list a detailed
calculation for each facility below, based on facility numbers
available as of May 2017 with a summary of these calculations provided
in Table 10:
RNHCIs: Combined total savings of $3,870 for 18 RNHCIs ((2
burden hours for an administrator at $105 plus 5 burden hours for a
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
ASCs: Combined total savings of $1,258660 for 5,557 ASCs
((1 burden hour for an administrator at $108 per hour plus 5 burden
hours for a quality improvement RN at $69 per hour) x 5,557 ASCs x 50
percent).
Hospices: Combined total savings of $929,223 for 4,489
hospice facilities (6 burden hours for a RN at $69 per hour x 4,489
hospices x 50 percent).
PRTFs: Combined total savings of $129,030 for 374 PRTFs
(10 burden hours for a RN at $69 per hour x 374 PRTFs x 50 percent).
PACE: Combined total savings of $96,462 for 233 PACE
organizations (3 burden hours for a home care coordinator at $69 per
hour plus 9 burden hours for a RN at $69 per hour x 233 PACE
organizations x 50 percent).
Hospitals: As we stated in the Emergency Preparedness
final rule (81 FR 63958), TJC-accredited hospitals are required to
train their staff for their assigned roles during emergencies (CAMH,
Standard EC.4.16, Eps 1-2, p. EC-13e). In addition, the TJC-accredited
hospitals also must provide on-going training to their staff, including
training on specific job-related safety (CAMH, Standard HR-2.30, EP 4,
CAMH Refreshed Core, January 2008, p. HR-11), and we expect that
emergency preparedness is part of such on-going training. As a result,
we estimate a combined total savings of $2,015,031 for 1,383 non-TJC
accredited hospitals (2 burden hours for an administrator at $108 per
hour plus 6 burden hours for a risk management director at $105 per
hour plus 28 hours for a healthcare trainer (RN) at $69 per hour plus 4
burden hours for a medical secretary at $34 per hour x 1,383 hospitals
x 50 percent).
LTCF: Combined total savings of $8,223,075 for 15,663
LTCFs (2 burden hours for an administrator at $105 per hour plus 8
burden hours for a director of nursing at $105 per hour x 15,663 LTCFs
x 50 percent).
ICF/IID: Combined total savings $1,691,918 for 6,097 ICF/
IIDs (2 burden hours for an administrator at $105 per hour plus 5
burden hours for a RN $69 per hour x 6,097 ICF/IIDs x 50 percent).
HHA: Combined total savings of $7,902,624 for 12,624 HHAs
(2 burden hours for an administrator at $105 per hour plus 2 burden
hours for a nursing director at $105 per hour plus 2 burden hours for a
director of rehab at $84 per hour plus 2 burden hours for an office
manager at $56 per hour plus 8 burden hours for a director of training
at $69 x 12,624 HHAs x 50 percent).
CORF: Combined total savings of $73,038 for 188 CORFs (5
burden hours for an administrator at $105 per hour plus 3 burden hours
for a physical therapist at $84 per hour x 188 CORFs x 50 percent).
CAH: Combined total savings of $968,974 for 1,343 CAHs (2
burden hours for an administrator at $105 per hour plus 9 burden hours
for a director of nursing at $105 per hour plus 3 burden hours for a
facility director at $96 per hour x 1,343 CAHs x 50 percent).
Organizations: Combined total savings of $828,324 for
2,076 Organizations (6 burden hours for an administrator at $105 per
hour plus 2 burden hours for a physical therapist at $84 per hour x
2,076 Organizations x 50 percent).
CMHCs: Combined total savings of $55,545 for 161 CMHCs (10
burden hours for a psychiatric RN at $69 per hour x 161 CMHCs x 50
percent).
OPOs: Combined total savings of $111,012 for 58 OPOs (2
burden hours for a director at $114 per hour plus 2 burden hours for a
medical director/physician at $198 per hour plus 12 burden hours for a
QAPI director at $105 per hour plus 8 hours for an organ procurement
coordinator at $105 per hour plus 16 burden hours for an education
coordinator at $69 per hour x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $6,125,306 ((2 burden
hours for an

[[Page 47728]]

administrator at $105 per hour plus 8 burden hours for a nurse
practitioner/physician assistant at $101 per hour x 4,160 RHCs x 50
percent) $2,117,440 + (2 burden hours for an administrator at $105 per
hour plus 8 burden hours for a nurse practitioner/physician assistant
at $101 per hour x 7,874 FQHCs x 50 percent) $4,007,866).
ESRD Facilities: Combined total savings of $2,855,772 for
6,898 dialysis facilities (3 burden hours for an administrator at $105
per hour plus 1 burden hour for a medical director/physician at $198
per hour plus 3 burden hours for a nurse manager at $105 x 6,898
dialysis facilities x 50 percent).

Table 10--Cost Savings: Training
----------------------------------------------------------------------------------------------------------------
Cost savings
Provider/supplier per provider/ Combined total savings
supplier
----------------------------------------------------------------------------------------------------------------
RNHCIs........................................ $215 $3,870 for 18 RNHCIs.
ASCs.......................................... 226 $1,258,660 for 5,557 ASCs.
Hospices...................................... 207 $929,223 for 4,489 hospice facilities both
inpatient and freestanding/home based.
PRTFs......................................... 345 $129,030 for 374 PRTFs.
PACEs......................................... 414 $96,462 for 233 PACE organizations.
Hospitals (Non-TJC accredited)................ 1,457 $2,015,031 for 1,383 non-TJC accredited
hospitals.
LTCFs......................................... 525 $8,223,075 for 15,663 LTCFs.
ICFs/IIDs..................................... 278 $1,691,918 for 6,097 ICF/IIDs.
HHAs.......................................... 626 $ 7,902,624 for 12,624 HHAs.
CORFs......................................... 389 $73,038 for 188 CORFs.
Organizations................................. 399 $828,324 for 2,076 Organizations.
CAHs.......................................... 721 $968,974 for 1,343 CAHs.
CMHCs......................................... 345 $55,545 for 161 CMHCs.
OPOs.......................................... 1,914 $1111,012 for 58 OPOs.
RHCs/FQHCs.................................... 509 $6,125,306 for RHCs and FQHCs ($2,117,440 for
4,160 RHCs and $4,007,866 for 7,874 FQHCs).
ESRD Facilities............................... 414 $2,855,772 for 6,898 dialysis facilities.
----------------------------------------------------------------------------------------------------------------

4. Testing
Finally, at Sec. 482.15(d)(2), we propose to require that
providers of inpatient services mentioned in section II.J.2 of this
proposed rule conduct two testing exercises annually, one of which may
be an exercise of their choice that must be either a community-based
full-scale exercise (if available), an individual facility-based
functional exercise, a drill, a tabletop exercise or workshop that
includes a group discussion led by a facilitator. We estimate that
revising this requirement to include additional options for the types
testing exercises that may be conducted for one of the two annually
required exercises will provide greater flexibility for these
providers. Given that these providers are currently required to conduct
two testing exercises annually, and because they may choose to conduct
the same types of testing exercises, we do not anticipate that this
requirement will impose a burden upon providers of inpatient services
and as such, this revision would not result in a savings of burden
hours or dollars.
We propose to require that providers of outpatient services
mentioned in section II.J.2 of this proposed rule conduct one testing
exercise annually which must be either a community-based full-scale
exercise (if available) or an individual facility-based functional
exercise every other year, and in the opposite years, may be either a
community-based full-scale exercise (if available), a facility-based
functional exercise, a drill, or a tabletop exercise or workshop that
includes a group discussion led by a facilitator.
For our analysis, we estimate that reducing this requirement from
biannually to annually for outpatient providers will reduce compliance
costs related to conducting emergency preparedness testing by 50
percent. The methodology used for our cost estimate analysis mirrors
the methodology used for the biannual testing requirement in the
Emergency Preparedness final rule (81 FR 63930) with a 50 percent
reduction in the cost estimate calculation. As in the Emergency
Preparedness final rule (81 FR 63930), we will assume that the same
individuals involved with developing training would typically also
develop the scenarios, materials, as well as any accompanying
documentation associated with testing exercises. Based on May 2016 BLS
salary data, we calculated the hourly mean wage for each position for
this requirement identified in the Emergency Preparedness final rule
(81 FR 63930) and decreased the cost by 50 percent due to the 50
percent reduction in the frequency requirement.
We estimate that the proposed change will accrue a total annual
cost savings of $9,117,425 and 25 burden hours. We list a detailed
calculation for each facility below, based on facility numbers
available as of May 2017 with a summary of these calculations provided
in Table 11:
ASCs: Combined total savings of $1,066,944 for 5,557 ASCs
((1 burden hour for an administrator at $108 per hour plus 4 burden
hours for a quality improvement RN at $69 per hour) x 5,557 ASCs x 50
percent).
Freestanding/home-based hospices: Combined total savings
of $557,520 for 4,040 hospice facilities (4 burden hours for a RN at
$69 per hour x 4,040 hospices x 50 percent).
PACE: Combined total savings of $40,193 for 233 PACE
organizations (4 burden hours for a home care coordinator at $69 per
hour plus 1 burden hours for a RN at $69 per hour x 233 PACE
organizations x 50 percent).
HHA: Combined total savings of $3,970,248 for 12,624 HHAs
(1 burden hour for an administrator at $105 per hour plus 3 burden
hours for a nursing director at $105 per hour plus 1 burden hours for a
director of rehab at $84 per hour plus 1 burden hour for an office
manager at $56 per hour plus 1 burden hours for a director of training
at $69 x 12,624 HHAs x 50 percent).
CORF: Combined total savings of $55,272 for 188 CORFs (4
burden hours for an administrator at $105 per hour plus 2 burden hours
for a physical therapist at $84 per hour x 188 CORFs x 50 percent).
Organizations: Combined total savings of $305,172 for
2,076 organizations (2 burden hours for an administrator at $105 per
hour plus 1

[[Page 47729]]

burden hour for a physical therapist at $84 per hour x 2,076
organizations x 50 percent).
CMHCs: Combined total savings of $22,218 for 161 CMHCs (4
burden hours for a psychiatric RN at $69 per hour x 161 CMHCs x 50
percent).
OPOs: Combined total savings of $12,673 for 58 OPOs (3
burden hours for a QAPI director at $105 per hour plus 2 burden hours
for an education coordinator at $69 per hour x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $3,086,721 ((2 burden
hours for an administrator at $105 per hour plus 3 burden hours for a
nurse practitioner/physician assistant at $101 per hour x 4,160 RHCs x
50 percent) + (2 burden hours for an administrator at $105 per hour
plus 3 burden hours for a nurse practitioner/physician assistant at
$101 per hour x 7,874 FQHCs x 50 percent)).
ESRD: As identified in the Emergency Preparedness final
rule (81 FR 64006), the current CFCs already require dialysis
facilities to evaluate their emergency preparedness plan at least
annually (Sec. 494.60(d)(4)(ii)); thus, we expect that all dialysis
facilities are already conducting some type of tests to evaluate their
emergency preparedness plans. As a result, ESRDs are not included in
the burden calculation.

Table 11--Cost Savings: Testing
----------------------------------------------------------------------------------------------------------------
Cost savings
Provider/supplier per provider/ Combined total savings
supplier
----------------------------------------------------------------------------------------------------------------
ASCs.......................................... $192 $1,066,944 for 5,557 ASCs.
Hospices (freestanding/home-based)............ 138 $557,520 for 4,040 hospices.
PACEs......................................... 173 $40,193 for 233 PACE organizations.
HHAs.......................................... 314 $3,970,248 for 12,624 HHAs.
CORFs......................................... 294 $55,272 for 188 CORFs.
Organizations................................. 147 $305,172 for 2,076 Organizations.
CMHCs......................................... 138 $22,218 for 161 CMHCs.
OPOs.......................................... 226 $13,137 for 58 OPOs.
RHCs/FQHCs.................................... 256 $3,086,721 ($1,067,040 for 4,160 RHCs and
$2,019,681 for 7,874 FQHCs).
----------------------------------------------------------------------------------------------------------------

We will submit a revised information collection request to OMB to
account for the burden hour and cost savings.

IV. Response to Comments

Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.

V. Regulatory Impact Analysis

A. Statement of Need

All major and many ostensibly minor government regulations should
undergo periodic review to ensure that they do not unduly burden
regulated entities or the American people, and reflect current
knowledge as to regulatory effects. In recent years, we have revised
the CoPs and CfCs to reduce the regulatory burden on providers and
suppliers. In doing so, we identified obsolete and burdensome
regulations that could be eliminated or reformed to improve
effectiveness or reduce unnecessary reporting requirements and other
costs, with a particular focus on freeing up resources that health care
providers, health plans, and States could use to improve or enhance
patient health and safety. We also examined policies and practices not
codified in rules that could be changed or streamlined to achieve
better outcomes for patients while reducing burden on providers of
care, and we identified non-regulatory changes that would increase
transparency and allow CMS to become a better business partner. In
accordance with these goals, we published three final rules that
identified unnecessary, obsolete, or excessively burdensome regulations
on health care providers, suppliers, and beneficiaries. These rules
further increased the ability of health care professionals to devote
resources to improving patient care by eliminating or reducing
requirements that impede quality patient care or that divert providing
high quality patient care:
``Reform of Hospital and Critical Access Hospital
Conditions of Participation'', published May 16, 2012 (77 FR 29034);
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction'', published May 16, 2012 (77 FR
29002) and;
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction; Part II'', published May 12, 2014
(79 FR 27105).

These reforms, however, did not exhaust the potential for burden-
reducing reforms. We have continued to consult with regulated entities,
have reviewed new research findings, have reviewed comments on previous
rulemakings, and in these and other ways have identified additional
reforms. These reforms are addressed in this proposed rule.
This proposed rule is not just a continuation of our efforts to
reduce regulatory burden but also directly responds to the January 30,
2017 Executive Order ``Reducing Regulation and Controlling Regulatory
Costs'' (Executive Order 13771). We propose changes to the current CoPs
or CfCs that will simplify and streamline the current regulations and
thereby increase provider flexibility and reduce excessively burdensome
regulations, while also allowing providers to focus on providing high-
quality healthcare to their patients. This proposed rule will also
reduce the frequency of certain required activities and, where
appropriate, revise timelines for certain requirements for providers
and suppliers and remove obsolete, duplicative, or unnecessary
requirements. Ultimately, these proposals balance patient safety and
quality, while also providing broad regulatory relief for providers and
suppliers, and reducing the associated burden on patients.

B. Overall Impact

We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995

[[Page 47730]]

(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and
Executive Order 13771 on Reducing Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we have prepared a RIA
that, to the best of our ability, presents the costs and benefits of
the rulemaking.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget. This
proposed rule would create ongoing cost savings to providers and
suppliers in many areas. Other changes we have proposed would clarify
existing policy and relieve some administrative burdens. We have
identified other kinds of savings that providers and patients will
realize throughout this preamble, and substantial lifesaving benefits.
These life-saving effects arise by removing the incentives created by
the current transplant center regulations to decline to transplant
patients with slightly lower probability of success, and to decline to
use organs with a slightly lower probability of success.
We welcome public comments on all of our burden assumptions and
estimates as well as comments identifying additional reforms that
should be considered for future rulemakings. As discussed later in this
regulatory impact analysis, substantial uncertainty surrounds these
estimates and we especially solicit comments on either our estimates of
likely impacts or the specific regulatory changes that drive these
estimates.
As stated in the ICR section of this proposed rule, we obtained all
salary information from the May 2016 National Occupational Employment
and Wage Estimates, United States by the Bureau of Labor Statistics
(BLS) at https://www.bls.gov/oes/2016/may/oes_nat.htm and calculated
the added value of 100 percent for overhead and fringe benefits.

Table 12--Section-By-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
Estimated
Number of annual
Provider and supplier type and description Frequency affected savings or
of proposed provisions entities benefits ($
millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
Institutions:
Discharge Planning............. As patients are discharged 18 *
(Estimated 619 annual discharges).
Ambulatory Surgical Centers:
Governing Body and Management.. Upon failed hospital transfer 5,557 *
agreement attempts.
Patient Admission, Assessment Every patient registration at an 5,557 (ASCs) 454
and Discharge (History and Physical). ASC or at a hospital outpatient/ 5,031
ambulatory surgery department. (Hospitals)
Medical Records................ Recurring annually................ 5,557 0
Hospices:
Drugs and Biologicals, Medical Recurring annually................ 1,151 80
Supplies, and Durable Medical Equipment.
Hospices That Provide Hospice Recurring annually................ 4,602 *
Care to residents of a SNF/NF or ICF/
IID.
Hospice Aide and Homemaker Recurring annually................ 3,498 2
Services.
Hospitals:
Quality Assessment and Recurring annually................ 5,031 28
Performance Improvement Program.
Medical staff: Autopsies....... Recurring annually................ 5,031 0
Infection Control.............. Recurring annually................ 5,031 105
Special requirements for Recurring annually................ 1,724 30
hospital providers of long-term care
services (``swing-beds'').
Special Requirements for Recurring annually................ 574 62
Psychiatric Hospitals.
Transplant programs:
Various provisions related to Recurring annually................ 750 Not Quantified
performance * *.
Home Health Agencies:
Patient rights................. Recurring annually................ 12,624 55
Home health aide services...... Recurring annually................ 12,624 0
Clinical records............... Recurring annually................ 12,624 0
Critical Access Hospitals:
Provision of Services.......... Recurring biennially.............. 1,343 2
Organizational structure....... Recurring annually................ 1,343 *

[[Page 47731]]

Special requirements for CAH Recurring annually................ 1,246 86
providers of long-term care services
(``swing-beds'').
Comprehensive Outpatient Rehabilitation
Facilities:
Utilization Review Plan........ Recurring annually................ 188 *
Community Mental Health Centers:
Assessment Update.............. Recurring annually................ 52 *
Portable X-Ray Services:
Qualifications of X-ray Annual............................ 500 31
technicians * * *.
Removing written orders........ Annual............................ 500 29
RHC (4,160 clinics) & FQHC (7,874 center
locations):
Provision of Services.......... Recurring biennially.............. 12,034 7
Program Evaluation............. Recurring biennially.............. 12,034 9
Emergency Preparedness for Providers and
Suppliers:
Annual Review of Emergency Recurring annually................ 72,844 94
Preparedness Program.
Emergency Plan................. Recurring annually................ 68,254 7
Training and Testing-Training Recurring annually................ 69,196 33
Program.
Training and Testing-Testing... Recurring annually................ 36,971 9
-------------------------------------------------------------------
Total Annual Savings................ .................................. .............. 1,123
Life-extending benefits for .................................. .............. Not Quantified
transplant patients.
----------------------------------------------------------------------------------------------------------------
* Amount is less than one million dollars.
** These include proposed changes to the following requirements: Special Requirements for Transplant Programs;
Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and
Special Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will increase in future years.

C. Anticipated Effects
1. Effects on Religious Nonmedical Health Care Institutions
As detailed in the Collection of Information section of this rule,
we propose to reduce the discharge planning requirements for RNHCIs
because RNHCIs do not provide medical treatment or services. Most
patients are discharged to home or to another facility that also does
not provide medical treatment or services. Although all patients must
have a discharge planning evaluation, not all patients require a
discharge plan. The discharge planning cost would be reduced by an
estimated $27,013.16.
2. Effects on Ambulatory Surgical Centers and Hospital Outpatient/
Ambulatory Surgery Departments
As of May 2017 there were 5,557 Medicare-participating ASCs. We
proposed to revise the ASC CfCs in order to reduce unnecessary
duplications and streamline processes in order to reduce ASC compliance
burden while maintaining minimum standards for patient safety and care.
The specific savings for each proposed change are described later in
this section of this proposed rule. At Sec. 416.41(b)(3), we propose
to remove the requirements related to transfer agreements and admitting
privileges. This change would eliminate the administrative burden
associated with preparing an agreement for signature and going through
the hospital credentialing process in order to obtain admitting
privileges. Currently, all Medicare-certified ASCs are meeting the
transfer agreement or admitting privileges requirement with the
exception of approximately twenty ASCs that have tenuous relationships
with their local hospital. We estimate the ASCs that do have difficulty
with meeting this requirement would appreciate the annual burden
savings of 2 to 4 administrator hours spent on paperwork and
documentation. For those already with the transfer agreements in place,
there would not be any more follow-up burden related to renewals or
updates to the documents. We estimate the savings at less than $10,000
overall and largely believe this change will not produce significant
savings, however, it does affect twenty or more ASCs in the short term
by removing the transfer agreement requirement. We welcome any feedback
related to the time and effort for those ASCs that have secured an
agreement, and if we have underestimated the savings of removing this
transfer agreement in the future. As previously discussed, the
enactment of EMTALA and its increasingly effective enforcement over
time has rendered these transfer and admitting privileges obsolete and
unnecessary. To put this point in perspective, emergencies or other
unforeseen adverse events can arise in any ambulatory medical or dental
setting, or in home settings. Over time, ``911'' emergency calls and
direct ambulance responses have become standard operating procedures
virtually nationwide, regardless of the place in which the problem
arose. Under modern procedures, emergency responders (and patients
themselves) take patients to hospital emergency rooms without regard to
prior agreements between particular physicians and particular
hospitals. Indeed, the most appropriate emergency treatment setting for
a particular patient may not be one involving such an agreement even
where the agreement exists. Of course, nothing prevents particular
arrangements where a hospital and ASC agree that this is beneficial for
a particular type of surgery or patient condition and where patient
transport can be appropriately arranged to reflect this. Accordingly,
we estimate that there will be no consequential adverse health effects
of this proposed change, and therefore estimate no medical costs.
There will be competitive benefits in those places where an ASC
will now be allowed to operate and provide care at reduced cost
compared to inpatient treatment. Nonetheless, we believe that the
number of affected areas and facilities are few, and that annual
benefits are unlikely to reach the

[[Page 47732]]

million dollar range. We welcome comments on these effects and on the
preceding analysis of health effects.
At Sec. 416.52 we propose to replace the requirement that every
patient must have a comprehensive H&P within 30 days prior to surgery
in an ASC with a requirement that allows the operating physician and
ASC to determine which patients would require more extensive testing
and assessment prior to surgery. We believe that this change would
reduce patient and provider burden in a multitude of ways that includes
the community-based physician, the ASC, and the patient. We believe
that in almost all situations ASCs can reasonably rely on existing H&P
results that are more than 30 days old and then are updated by patient
responses on the day of surgery, but we cannot forecast with any
precision what medical specialty societies, ASC governing bodies,
hospital governing bodies, or accreditation bodies will decide to do in
replacing the current requirement. Therefore, we do not forecast
specific cost savings at this time, and solicit public comments to help
us with our estimate in the final rule.
For ASCs, we believe this change would reduce administrative burden
by decreasing the amount of time that ASC personnel spend following up
on patient visits to obtain the necessary H&P information and that it
will provide for an increase in scheduling flexibility for the
facility. We believe these changes may have the effect of improving
patient satisfaction and increasing positive patient referrals for the
ASC.
For community-based healthcare providers, to include primary care
providers, we believe this change would reduce unnecessary examinations
that are required to be performed and reduce administrative paperwork
burden associated with providing ASCs with the necessary H&P
documentation and additional testing requirements. This change may
potentially provide an opportunity for increased access to community-
based providers because of available appointments that are not being
filled by unnecessary patient appointments for H&P requirements for
surgery in an ASC. Those vacant appointments may also generate more
revenue.
For patients, we believe this change would reduce the time spent to
prepare for surgery (time in community-based physician office, travel
time and costs, time missed from the work place and lost productivity)
and the cost associated with co-pays and other healthcare cost sharing
requirements.
Finally, we believe this change would reduce expenses for
healthcare insurers to include Medicare, Medicaid, and private
healthcare insurance companies. This change would reduce costs
associated with reduced pre-operative exams, laboratory testing, chest
radiographs, and echocardiograms.
It is difficult to estimate the savings from this change, because
they depend on a number of factors previously described, and additional
factors for which we do not have precise measures, such as the number
of patients (both Medicare and non-Medicare) who received two or more
ASC services within the 30-day window allowed for one physical
examination. This is a common occurrence because, for example, patients
often receive cataract surgery on one eye and then, a week later, on
the other eye. Furthermore, there are an immense number of different
outpatient surgical services. At present, for example, there are about
137 services that account for about 90 percent of ASC volume, and these
services are highly diverse, as shown in Table 13.

Table 13--Twenty Most Frequent ASC Services in 2015
------------------------------------------------------------------------
Percent of
Surgical service Rank volume
------------------------------------------------------------------------
Cataract surgery w/IOL insert........... 1 18.60
Upper GI endoscopy, biopsy.............. 2 8.2
Colonoscopy and biopsy.................. 3 6.8
Lesion removal colonoscopy (snare 4 5.6
technique).............................
Inject foramen epidural: Lumbar, sacral. 7 4.8
After cataract laser surgery............ 6 4.4
Injection spine: Lumbar, sacral (caudal) 8 3.3
Inject paravertebral: Lumbar, sacral.... 9 3.1
Diagnostic colonoscopy.................. 5 2.3
Colorectal screen, high-risk individual. 10 2.0
Colorectal screen, not high-risk 12 1.9
individual.............................
Cataract surgery, complex............... 11 1.6
Injection procedure for sacroiliac 19 1.3
joint, anesthetic......................
Cystoscopy.............................. 15 1.2
Upper GI endoscopy, diagnosis........... 13 1.0
Inject spine, cervical or thoracic...... 17 1.0
Revision of upper eyelid................ 16 0.9
Lesion removal colonoscopy (hot biopsy 14 0.8
forceps)...............................
Upper GI endoscopy, insertion of guide 18 0.8
wire...................................
Carpal tunnel surgery................... 20 0.7
-------------------------------
Total............................... .............. 70.4
------------------------------------------------------------------------
Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.

In total, ASCs provided about 6.4 million services in 2015 (MEDPAC.
Ambulatory surgical centers services, 2017, p. 139). If we assume that
25 percent of these had two or more services within the 30-day
``window'' allowed in the current rule, then another H&P with its
associated battery of tests were required for each of the remaining 4.8
million individuals. Assuming that 5 percent of these would otherwise
have already had an overall H&P and associated tests within 30 days of
the surgery, 4.56 million persons would then require a new H&P and
tests before surgery under the current requirements. In the great
majority of cases involving eye or eyelid surgery of one kind or
another, the ophthalmology examination preceding the ASC surgery would
not have involved a

[[Page 47733]]

comprehensive H&P or battery of tests, and a similar situation would be
involved for most other surgeries preceded by specialist rather than
primary care visits.
Although we are unable to estimate the likely number of cases, one
way to estimate the costs of these examinations and tests would be as
follows. First, the H&P itself would cost approximately $100 (the exact
amount depending on diagnostic details, and not necessarily
corresponding to any particular payment schedule). The battery of tests
would cost approximately $100, assuming both urine and blood testing,
and, in some cases, an electrocardiogram, but only half of physical
examinations (for example, few or no ophthalmologist exams) would
include such tests. The travel of the patient to and from the physician
office to obtain the examination and tests would on average require 1
hour, which when valued at the average wage rate in the economy of $24
(increased by 50 percent to include fringe benefits but not overhead)
would cost about $36. In addition, ASCs incur substantial costs for the
time and trouble needed to contact physician offices and arrange for
the results to be delivered. The physician offices themselves would be
put through the trouble of transferring those medical records. Assuming
average time spent (the median would be less but a small number of
difficult cases would bring the average well above the median) would
reach 10 minutes, and the use of a general office clerk at $32 an hour,
the cost per patient would average $5 per patient. A further cost
arises because in many cases the examination and test results simply
cannot be obtained timely, and a scheduled surgery has to be postponed.
Assuming that in such cases a half hour of surgeon time (at $243 an
hour) and a half hour of registered nurse (RN) time (at $69 an hour) is
wasted, and that clerical time ($32 an hour) to reschedule averages 10
minutes, the average cost per postponement would be $161. (In some of
these cases patient time would be wasted, as well as the time of family
members accompanying the patient--we have not estimated these costs.)
Aggregating these calculations, one estimate of the annual costs of
the current regulatory requirement, as shown in Table 14, could be as
much as $972 million for ASCs and a similar amount for hospital
outpatient surgery. For many and perhaps most cases, however, either
the surgeon or the facility would decide that H&P information is needed
for particular patients or particular procedures whether or not this
regulatory requirement existed. Of course, it is unlikely that in such
cases a strict 30-day window would be insisted on. Assuming that such
examination and testing information would continue to be needed for 10
percent of all patients, and that in half of these cases the
information would require a new examination and tests within a 30-day
window, the net costs of the current regulatory requirement would be 5
percent less than the preceding calculations. Supposing that such
examination and testing information would still be required for 50
percent of all patients, the costs of the current requirement and hence
the potential savings from its reform would fall much further. Absent
more specific information, the estimates of potential costs and savings
in Table 14 are suggestive but not robust until or unless improved
through public comment and additional information. In our summary
estimates, we have assumed a range of savings from zero to 50 percent,
with a midpoint of 25 percent.
As support for the 50 percent upper bound, we note that Chen CL,
Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA
and Dudley RA, Preoperative Medical Testing in Medicare Patients
Undergoing Cataract Surgery, New England Journal of Medicine 372:1530-
1538, April 16, 2015, find that approximately 53 percent of Medicare
cataract patients undergo pre-operative testing, none of which is
mandated by CMS regulation. If these patients' physicians are cautious
enough to currently pursue more preoperative activity (testing, H&P,
etc.) than what is required, or state or hospital rules are driving
physician behavior beyond what Medicare necessitates, then there is
little reason to believe that that behavior will change with the
finalization of this rule. Given that other procedures tend to be more
invasive than cataract surgery, pre-operative caution on the part of
physicians is likely to be even greater in the non-cataract context.
Indeed, Benarroch-Gampel J, Sheffield KM, Duncan CB, Brown KM, Han Y,
Townsend CM and Riall TS, Preoperative Laboratory Testing in Patients
Undergoing Elective, Low-Risk Ambulatory Surgery, Annals of Surgery
256(3):518-528, September 2012, and Fischer JP, Shang EK, Nelson JA, Wu
LC, Serletti JM and Kovach SJ, Patterns of Preoperative Laboratory
Testing in Patients Undergoing Plastic Surgery Procedures, Aesthetic
Surgery Journal 1(1):133-141, January 2014, find that almost two-thirds
of hernia procedures are preceded by testing, as are 62 percent of
ambulatory plastic surgeries. This leaves an upper bound of 33 to 38
percent of non-cataract outpatient surgery H&P costs that could
reasonably be expected to be avoided as a result of this rulemaking. In
order to more successfully tailor the upper bound of potential cost
savings to H&P activity--rather than just extrapolating from testing
behavior--we request comment on the possibility of building on Chen et
al.'s data and methodology to estimate the increased frequency of
within-30-day office visits (presumed to be H&P) when ophthalmologist
visits are at least 31 days prior to surgery relative to when
ophthalmologist visits are no more than 30 days prior.
As noted in the medical literature previously discussed, Chung F,
Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of
preoperative testing in ambulatory surgery. Anesth Analg. 2009 Feb,
108(s):467-75, there are no known consequential medical benefits from
the testing often performed in association with the current regulatory
requirements. This study covered hernia patients but similar results
have been found in studies of cataract surgery. Accordingly,
eliminating the testing could in theory produce very substantial annual
ASC cost savings with no offsetting medical cost increases or harm to
patients. H&P itself, however, is distinct from testing, and literature
indicating that testing is wasteful does not necessarily speak to the
importance of H&P. Therefore, if H&P is avoided, rather than more
thoroughly integrated into same-day presurgical assessments, there
could be adverse consequences to patients; these impacts have not been
quantified.
As discussed in ``Provisions of the Proposed Regulations,'' section
II.D. 2. of this proposed rule, there is a similar regulatory
requirement for hospital outpatient surgery. Based on the substantial
similarity between these two service settings, we also propose to
eliminate these requirements for such surgery. Although we do not have
detailed data for hospital outpatient surgery, it is widely agree to be
roughly equal in size and composition to ASC surgery, though spending
is higher because a higher payment schedule is used by some insurers,
including Medicare, for most hospital outpatient surgery. Regardless,
estimates should be based on economic costs, not any particular payment
schedules. Accordingly, potential total annual savings, and hence
benefits, for both settings taken together could be as much as $1.7
billion. This would depend on whether hospital-based outpatient

[[Page 47734]]

surgery decisions parallel those of independent ASCs.
If, after ASCs and hospitals make policy decisions on which types
of outpatient/ambulatory surgery patients would require a comprehensive
H&P, it is found that only 50 percent of current costs were continued,
potential total annual savings, and hence benefits, for both settings
taken together could be as much as $908 million, assuming that
hospital-based outpatient surgery H&P policy decisions parallel those
of independent ASCs. Alternatively, if 75 percent of current costs were
continued, potential savings would be only about $454 million annually.
While the literature shows that we can be reasonably certain that for
some procedures, such as cataract surgery, few or possibly even no
costs would be self-imposed, there may be other procedures where
ensuing policy decisions would retain all current history and physical
requirements, though likely removing the strict 30-day rule. Because of
the proposed requirements, and other uncertainties, the potential
savings from lifting the current requirements encompass at least this
broad range and quite possibly more. Because there is great uncertainty
in these estimates we have decided not to present a predetermined
figure in this proposed rule. Instead, we are requesting public
comments on all the parameters of our estimates to inform the estimates
we will make in the final rule. We welcome information on likely
decisions in both ASC and hospital outpatient settings, and if possible
for the most common procedures shown in Table 13 and for the likelihood
and cost saving effects for procedure and patient categories where the
facility chooses to retain an external H&P requirement, but extends the
time window to a year or some other period that is far longer than 30
days.

Table 14--Current Costs and Potential Annual Savings From Creating and Obtaining Examination and Test Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
Twenty-five Seventy-five
Type of cost Unit cost Number (M) Current total percent Fifty percent percent
cost ($M) retained ($M) retained ($M) retained ($M)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical Examinations................................... $100 4.56 $456 $114 $228 $342
Test Batteries.......................................... 100 2.28 228 57 114 171
Patient Travel Cost..................................... 36 4.56 164 41 82 123
Administrative Cost to ASC.............................. 5 4.56 23 6 11 17
Surgery Cancellations *................................. 161 0.228 37 9 18 28
-----------------------------------------------------------------------------------------------
Total Cost, ASCs.................................... .............. .............. 908 227 454 681
Total Cost, Hospital Outpatient **.................. .............. .............. 908 227 454 681
-----------------------------------------------------------------------------------------------
Total Cost.......................................... .............. .............. 1,815 454 908 1,362
-----------------------------------------------------------------------------------------------
Total Savings....................................... .............. .............. .............. 1,362 908 454
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of scheduled cataract operations are cancelled at
the last minute since the required H&P information has not arrived from the physician office where the examination was performed and the tests ordered
or performed. Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $243 an hour), one half hour of RN time
wasted (at $69 an hour), and ten minutes of clerical time (at $32 an hour) to reschedule.
** Hospital outpatient savings assumed to be equal to ASC savings.

We assume that the one-time costs of developing such policies for
hospital outpatient surgery in 5,031 Medicare-participating hospitals
would be the same in the aggregate, though the mix of personnel used
would be somewhat different and the cost at free-standing hospitals
would likely be several times higher (for example, for involvement of
the governing body and legal review). About 3,200 of these hospitals
are in multi-hospital systems that would, however, reap economies of
scale, and about 574 are psychiatric hospitals that we assume rarely
perform surgery. In total, we estimate that, first year savings for
both types of facilities would be $38 million less, regardless of the
replacement rules that each facility imposed on itself.
There are possible alternatives, including limiting the regulatory
reform to the lowest risk procedures, which would probably mean almost
all procedures, excluding certain procedures from the regulatory
reform, exempting ASCs, but not hospital outpatient departments,
changing the 30-day requirement to something much longer in duration
such as 6 months or a year, and likely others. Absent contrary
evidence, however, we believe that relying on physician and facility
judgment maximizes benefits and presents no consequential costs.
We welcome comments on these estimates and on both the proposal and
any alternatives, and particularly welcome any evidence-based
information that would inform both our ability to provide cost savings
estimates and a policy choice between either the proposed reform or an
alternative.
3. Effects on Hospices
As of May 2017 there are 4,602 Medicare participating hospices. We
proposed to revise the hospice CoPs in order to reduce unnecessary
duplications and streamline processes in order to reduce hospice
compliance burden while maintaining minimum standards for patient
safety and care.
At Sec. 418.76(a) we propose to defer to State training and
competency requirements, where they exist, for hospice aides. Deferring
to state requirements would streamline the hiring process because
hospices would not have to verify that a job candidate's qualifications
meet or exceed the Federal standard in addition to verifying that the
candidate meets State requirements.
According to the BLS, 408,920 aides are currently employed in
``home care''. The term ``home care'' encompasses both home health
agency and hospice employers. There are 12,624 HHAs and 4,602 hospices,
meaning that hospices represent 27 percent of the ``home care''
employer market. Thus, we conclude that hospices employ 110,408 aides
(27 percent of all aide positions in ``home care''). Based on an
informal survey conducted by the largest hospice industry association,
76 percent of

[[Page 47735]]

States have their own training and competency requirements, accounting
for approximately 83,910 aide positions. Hospices in these states would
benefit from the proposed change because they would be permitted to
rely on the completion of state mandated training and competency
programs to assure that a candidate is qualified for employment, and
would no longer have to take the additional step of verifying that each
potential job candidate also meet the Federal requirements. We assume a
25 percent turnover rate based on discussions with industry experts, or
20,978 aide job listings per year. Based on an assumed 20 candidates
that would require the qualifications verification per job listing, we
estimate that hospices must verify the training and competency program
content and format for 419,560 candidates per year. We assume that it
would take 10 minutes per candidate to verify compliance with the
Federal requirements, for a total of 69,927 hours per year nationwide.
At a cost of $32 per hour for a general office clerk to perform this
check, we estimate that hospices will save $2,237,664 annually.
At Sec. 418.106(a) we propose to delete the requirement that a
hospice must ensure that the interdisciplinary group confers with an
individual with education and training in drug management as defined in
hospice policies and procedures and State law, who is an employee of or
under contract with the hospice to ensure that drugs and biologicals
meet each patient's needs. Not requiring the specific pharmacy
advisement function would allow for more streamlined interdisciplinary
group meetings. We assume that 25 percent of hospices currently use
their own staff (employee or contract) for this function, and that this
staff member is typically the nurse member of the interdisciplinary
group. The nurse member of the interdisciplinary group is also required
by Sec. 418.56(a); therefore we believe that removing this requirement
will not result in removing the expertise from the group. Rather, we
believe that removing this requirement will remove the formulaic
approach to interdisciplinary discussions whereby the group allots time
in each meeting specifically for this discussion in order to assure
regulatory compliance. In the absence of regulation, the
interdisciplinary group would have the authority to decide whether the
discussion is pertinent for a given patient and the information can be
woven into the discussion at large. This approach has the potential to
reduce the overall group discussion time, particularly for the 3
members of the interdisciplinary group that are not charged with being
the pharmacology expert. Based on 1.6 million hospice patients and an
assumed 3 interdisciplinary group meetings per patient, there are a
total of 4,800,000 interdisciplinary group meetings per year. We assume
that each interdisciplinary group meeting includes 2 minutes of time
specifically related to discussing the results of the pharmacy
advisement service for purposes of complying with the regulation, or
160,000 hours per year nationwide. At a cost of $299 per hour ($198
physician + $53 social worker + $48 pastoral counselor), we estimate
that removing this requirement would save $47,840,000 annually.
Additionally, we believe that this change would reduce the
specialist nursing time spent specifically on advisement services. We
believe that moving away from a regulatory compliance ``check box''
approach would allow the specialist nurse to incorporate medication
management more seamlessly into regular clinical practice. The 2008
Hospice CoP final rule (73 FR 32088) estimated a 1 hour burden per
patient for expert pharmacy services (30 minute initial advisement per
patient + 2 15 minute update advisements) for a total cost of $69 per
patient for all advisement services (updated to 2017 dollars). We
estimate that this proposed change would reduce that time by 50
percent, to 30 minutes per patient, resulting in a $35 per patient
savings. Based on the assumption that 25 percent of hospices use their
own employee to perform this function, we estimate that this reduction
would occur for 400,000 patients nationwide (25 percent of 1.6 million
hospice patients), for a total annual savings of $14,000,000.
Together with the previously stated estimate, total savings would
be $47,840,000 + $14 million = $61,840,000 annually.
We propose to revise the requirement at Sec. 418.106(d) to allow
hospices to provide information regarding safe medication use, storage,
and disposal in a more understandable manner. Under the current
requirements, hospices are required to provide patients and families
with a copy of the hospice's policies and procedures, which are not
written in layperson terms. The proposed change would alleviate the
burden associated with addressing the confusion created by the policies
and procedures document. Following the initial cost of $483,210
(described in section III.E. of this rule) for developing new, more
easily understandable materials for patient education, we believe that
hospices would realize a savings of 10 minutes per patient because it
would require less hospice staff time to explain the more
understandable material. Based on an assumed 10 minutes of saved
nursing time per patient, and 1.6 million patients, hospices would save
266,667 hours. At a cost of $69 per hour, the total savings would be
$18,400,023.
First year: $18,400,023 savings-$483,210 initial year cost =
$17,916,813 net savings.
Annually thereafter: $18,400,023 savings.
At Sec. 418.112(f) we propose to allow hospices and long term care
facilities the additional flexibility to negotiate the format and
schedule for orienting long term care facility staff regarding certain
hospice-specific information. We believe that this would allow for
innovation and streamlining, and reduce hospice compliance costs
related to this requirement by 20 percent. For purposes of our analysis
only, we assume that a typical hospice conducts 6 orientation sessions
per year, and that each orientation requires 2 hours of time from a
hospice nurse. At a cost of $69 per hour, a typical hospice would spend
$828 each year to orient long term care facility staff. Assuming a 20
percent reduction in burden that can be achieved through innovation and
streamlining, a typical hospice would save $166 a year, or $763,932
savings annually for all 4,602 hospices.
Taken together, these proposed reforms would generate annual
savings of approximately $82.8 million ($47.8 million for reduced
interdisciplinary group meeting time + $14 million for reduced
specialty nursing time + $18 million for streamlined controlled drug
education practices + $2.2 million for streamlined hospice aide
qualification requirements + $0.8 million for streamlined facility
staff orientation). We welcome public comment regarding these burden
estimates, and additional regulatory reforms to reduce the burden of
the hospice CoPs.
4. Effects on Hospitals
As of May 2017, there were 5,031 Medicare participating hospitals.
We propose to revise the hospital CoPs in order to simplify some
requirements and streamline processes in order to reduce burden
associated with hospital compliance with the Medicare CoPs while
maintaining minimum health and safety standards. The specific savings
for each proposed change are described below.

[[Page 47736]]

At Sec. 482.21, we propose to allow for multi-hospital systems
using a system governing body, as allowed under the CoPs, and that is
legally responsible for two or more separately certified member
hospitals, to have a unified QAPI program for the member hospitals
subject to the system governing body. This will afford hospitals
flexibility and the ability to gain efficiencies and achieve
significant progress in quality by sharing best practices among all
hospitals subject to the system governing body. This would be similar
to current allowances for system governing bodies and unified medical
staffs.
While there are no current requirements that explicitly prohibit
the sharing of best practices across a system, the current requirements
for each hospital to have its own separate and distinct QAPI program
and Infection Control program certainly have inhibited and stifled
sharing of best practices and innovations among individual hospitals
within a system as we point out in the preamble to this proposed rule,
and which we support with our reference to the Health Research and
Educational Trust, in partnership with the American Hospital
Association March 2010 publication entitled, ``A Guide to Achieving
High Performance in Multi-Hospital Health Systems.'' This publication,
along with positive public comments regarding unified medical staffs
that we discussed in the May 2014 final rule and to which we refer in
this proposed rule, clearly point to multi-hospitals more efficiently
and effectively collecting, disseminating, and sharing innovations,
solutions, and best practices for patient care to each of its member
hospitals through these unified patient care programs.
Approximately 3,200 of the 5,031 Medicare-participating hospitals
participate in a hospital system (American Hospital Association (AHA),
Fast Facts 2017 (https://www.aha.org/system/files/2018-01/fast-facts-us-hospitals-2017_0.pdf)). According to the 2017 AHA Guide, there are
424 multi-hospital systems. The current regulatory burden for
compliance with the QAPI program requirement is approximately $10,000
annually per hospital or $50.3 million annually for all 5,031
hospitals. If we were to allow a unified QAPI program for multi-
hospital systems, this would remove 3,200 hospitals from the total
5,031 (replaced by the 424 multi-hospital systems) for a total of 2,255
hospitals/multi-hospital systems that would still need to comply. The
new regulatory burden would be a total of approximately $22.6 million
annually (2,255 x $10,000), for an annual total savings of
approximately $28 million. We welcome comments on the quantitative and
non-quantitative portions of the preceding discussion and seek any
empirical evidence that would improve the accuracy and thoroughness of
the relevant benefits estimation.
We propose to remove the requirement for hospitals at Sec.
482.22(d), which states that a hospital's medical staff should attempt
to secure autopsies in all cases of unusual deaths and of medical-legal
and educational interest. Because this requirement is redundant and
more detailed, specific requirements regarding medical-legal
investigative autopsies are required by individual state law, we do not
anticipate that hospitals would accrue additional savings from this
change. The benefit to hospitals from eliminating this requirement is
realized through a reduction in burden from no longer having to comply
with two similar requirements of the Federal government and the State
government. Hospitals would instead be required to follow the more
detailed, specific regulations of the state in which they are located.
At Sec. 482.42, we propose to allow for multi-hospital systems
using a system governing body as currently allowed under the CoPs, and
that is legally responsible for two or more separately certified member
hospitals, to have a unified infection control program for those member
hospitals subject to the system governing body. This would allow
hospitals flexibility and the ability to gain efficiencies and achieve
significant progress in infection prevention and control. This would
also be similar to current allowances for system governing bodies and
unified medical staffs.
The current regulatory burden for compliance with the Infection
Control program requirement is approximately $191 million annually for
all hospitals or $38,000 per hospital. If we were to allow a unified
Infection Control program for multi-hospital systems, this would remove
3,200 hospitals from the total 5,031 (replaced by the 424 multi-
hospital systems) for a total of 2,255 hospitals/multi-hospital systems
that would still need to comply. The new regulatory burden would be a
total of approximately $86 million annually (2,255 x $38,000), for an
annual total savings of approximately $105 million. We welcome comments
on the quantitative and non-quantitative portions of the preceding
discussion and seek any empirical evidence that would improve the
accuracy and thoroughness of the relevant benefits estimation. At
Sec. Sec. 482.58(b)(1) and 485.645(d)(1) (cross-referenced long-term
care requirement at Sec. 483.10(f)(9)) we propose to remove the
requirement for hospital and CAH swing-bed providers to provide the
right for patients to choose to or refuse to perform services for the
facility and if they so choose, (a) document in the resident's plan of
care, (b) noting whether the services are voluntary or paid and (c)
provide wages for the work being performed given the location quality,
and quantity of work requiring comparable skills. We discuss the
economic impact for this provision in the ICR section of this rule,
which is estimated to be $32 million.
At Sec. 482.58(b)(4) (and Sec. 485.645(d)(4)) (cross-referenced
long-term care requirement at Sec. 483.24(c)), we propose to remove
the requirement for hospital and CAH swing-bed providers to provide an
ongoing activity program that is directed by a qualified therapeutic
recreation specialist or an activities professional who meets certain
requirements as listed at Sec. 483.24(c)(2). We discuss the economic
impact for this provision in the ICR section of this rule, which is
estimated to be $81 million.
We propose to remove the requirement at Sec. Sec. 482.58(b)(5) and
485.645(d)(5) (cross-referenced long-term care requirement at Sec.
483.70(p)) for hospital and CAH swing-bed providers to employ a
qualified social worker on a full-time basis if the facility has more
than 120 beds. Given that this provision is not applicable to either
provider type due to the regulatory requirements for each, it does not
impose a burden upon hospitals and as such, its removal would not
result in a savings of burden hours or dollars.
At Sec. Sec. 482.58(b)(8) and 485.645(d)(8) (cross-referenced
long-term care requirement at Sec. 483.55(a)(1)) we propose to remove
the requirement for hospital and CAH swing-bed providers to assist in
obtaining routine and 24-hour emergency dental care to its residents.
We discuss the economic impact for this provision in the ICR section of
this rule, which is estimated to be $2.9 million for all hospital and
CAH swing-bed providers.
At Sec. 482.61(d), we propose to allow non-physician practitioners
to document progress notes in accordance with State laws and scope of
practice requirements. We discuss the economic impact for this
provision in the ICR section, which is estimated at $54.7 million in
savings for psychiatric hospitals.

[[Page 47737]]

5. Effects on Transplant Programs and Patients
There are approximately 750 Medicare approved transplant programs
in the United States, of which 250 are kidney transplant programs. All
Medicare approved transplant programs must be a part of a Medicare
approved hospital, and many hospitals have several types of organ
programs. Oversight of these programs occurs in two major ways: By the
Organ Procurement and Transplantation Network (OPTN), which is a non-
profit membership-based organization operated under a Federal contract
administered by the Health Resources and Services Administration
(HRSA), and by CMS under the CoPs. The current and long-term OPTN
contractor is the United Network for Organ Sharing (UNOS), which
performs many transplantation functions, including matching donated
organs to waiting lists of patients who have failing organs, and
reviewing the performance of transplant centers on a variety of
criteria, including patient and organ survival. There is a third
mechanism encouraging better transplant program performance, the SRTR
(accessed at https://www.srtr.org). The SRTR, also operated under a
HRSA contract, provides detailed data on the performance of all
transplant programs, and allows the OPTN, individual transplant
programs, and patients themselves to compare results on such vital
metrics as patient survival rates after transplant.
For patients with most types of organ failure, a transplant is the
only option for long-term survival. In the case of kidney failure,
however, kidney dialysis is a viable medium-term and sometimes long-
term option for most patients. On average these patients can survive a
dozen or more years on dialysis; however, without a transplant, they
suffer increasingly high morbidity and mortality rates. We provide
Medicare coverage for such patients through the ESRD program. Under the
ESRD program, patients receive dialysis treatment, usually three times
a week, through machines that cleanse their blood in much the same way
as healthy kidneys would do. Since its inception in 1973, more than one
million patients have received treatment under this program. Kidney
failure patients are unique in another way: Unlike most other organs,
with the partial exception of some liver donations, it is possible for
living individuals to donate ``live'' kidneys, whether the living donor
is a relative or an unrelated altruistic donor. In the case of ESRD
patients, the Medicare ESRD program serves almost all kidney failure
patients, regardless of age, and these patients receive costly dialysis
for a prolonged period of time. As is the case for all CoPs, our
regulations for Medicare-approved organ transplant programs have the
potential to protect all patients, not just Medicare beneficiaries.
As discussed earlier in this preamble, we have long regulated
transplant programs, but put in place additional CoPs in the March 2007
final rule (72 FR 15198) in an effort to increase the quality of care
by specifying minimal health and safety standards. In addition, outcome
metrics (1 year graft and patient survival) were included in the
regulation and mirrored the OPTN outcomes metrics as calculated by the
SRTR. Over time, increased emphasis on organ and patient survival
rates, as key metrics of transplant performance, created incentives for
transplant programs to select organs most likely to survive after
transplant without rejection, and to select recipients most likely to
survive after the transplant. In particular, due to the increasing
patient and organ survival rates over time, the 2007 standards have
become increasingly stringent over time as an artifact of the
performance calculation method established in the 2007 rule, an outcome
that was never intended by CMS. In addition, the 2007 rule created
performance standards that focused only on organ and patient survival
rates for those who received a transplant, not on survival rates of
patients awaiting transplant. We refer readers to a discussion of this
problem in the following CMS compliance Guidelines that could only
partially lighten this unintended regulatory burden at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-24.pdf.
There is extensive literature on these incentives and other
phenomena in transplant medicine that strongly suggests some unintended
consequences on organ utilization (decreased use of ``marginal'' organs
in their patients) and de-selection of some patients who are slightly
less likely to survive for an extended period post-transplant. These
unintended consequences have been anecdotal and measuring the extent to
which they have occurred is difficult. In addition to the studies
previously cited in the preamble (Adler et al., Schold et al., Dolgin
et al., Stewart et al., Husain et al.), other studies on this issue
include Kasiske B, Salkowski N, Wey A, Israni A, and Snyder J,
``Potential Implications of Recent and Proposed Changes in the
Regulatory Oversight of Solid Organ Transplantation in the United
States,'' American Journal of Transplantation, Volume 16, Issue 12,
December 2016, pages 3371-3377; Howard R, Cornell D, and Schold J,
``CMS Oversight, OPOs and transplant centers and the law of unintended
consequences, Clinical Transplantation, Volume 23, Issue 6, November/
December 2009, pages 778-783; and Abecassis M, Burke R, Klintmaim G,
Matas A, Merion R, Millman D, Olhoff K, and Roberts J, ``American
Society of Transplant Surgeons Transplant Center Outcome Requirements--
A Threat to Innovation,'' American Journal of Transplantation, Volume
9, Issue 6, June 2009, pages 1279-1286; and Schold J, Miller C,
Mitchell H, Buccine L, Flechner S, Goldfarb D, Poggio E, and Andreoni
K, ``Evaluation of Flagging Criteria of United States Kidney Transplant
Performance: How to Best Define Outliers,'' Transplantation, June 2017,
Volume 101, Issue 6, pages 1373-1380. These studies regarding the
reduced number of transplants that would otherwise have occurred,
yielded several relevant facts. The number of deceased donor organs
that are discarded has been increasing over time and for kidneys, is
above 20 percent. For example, about 33 percent of kidneys recovered
from donors age 50 to 64 are discarded, as are about 62 percent of
kidneys recovered from donors age 65 or older (Hart A. et al., OPTN/
SRTR 2015 ``Annual Data Report: Kidney.'' Accessed at http://onlinelibrary.wiley.com/doi/10.1111/ajt.14124/full). Officials of the
UNOS have stated at public meetings that in their judgment up to 1,000
kidneys of the approximately 3,000 that are discarded each year are of
good enough quality to be transplanted successfully. The number of
organ transplantations reached record highs in 2016 (33,500), about 20
percent more than 5 years earlier, due mainly to increased donation
rates (OPTN, ``United States organ transplants and deceased donors set
new records in 2016.'' Accessed at https://optn.transplant.hrsa.gov/news/us-organ-transplants-and-deceased-donors-set-new-records-in-2016/
).
For purposes of this analysis, one approach to estimating effects
is to isolate the number of kidneys (and other organs) that have been
discarded as a result of the March 2007 rule; indeed, a reasonable
assumption would be that this proposed rule's rescission of the 2007
requirements would have an equal and opposite effect. A slide
presentation by UNOS researcher Darren Stewart (2017; accessed at
https://www.myast.org/sites/default/files/ceot2017/AST%20CEOT%2001%20

[[Page 47738]]

Stewart%20-%20No%20Organ%20Left%20Behind%20-%20S3.pdf), presents an
estimate that about 1,110 of about 2,759 kidneys discarded in 2012 were
of transplant quality and that between 500 and 1,000 of these could
have been used in transplants (the most recent discard numbers, for
2016, are about 20 percent higher than in 2012 and one-third higher
than in 2007). This presentation cites the study previously discussed
in this preamble (Stewart et al. (2017)), that shows kidney discard
rates rising from between 5 and 7 percent in the late 1980s to 19.2
percent in 2015. Notably, the discard rate had already reached
approximately 18 percent by 2007, making the rate of increase much
lower after the March 2007 rule was implemented than it had been in the
previous two decades. Although this contrary evidence is far from
definitive, it suggests that the effect of the March 2007 rule was too
small to be observable in the kidney discard data.
Unfortunately, these and other studies have had to deal with other
trends during the last two decades that greatly complicate measuring
the independent effect of the 2007 rule. These include the increasing
age of the donor pool and the attendant decline in some dimensions of
organ quality, and the opposite effects of improved techniques for
maintaining organ quality between the time of donation and the time of
transplantion. As a result, the published studies using data on organ
discards have had to use complicated multivariate statistical
procedures in attempting to estimate the effects of the 2007 rule, and
invariably conclude that their findings are subject to considerable
uncertainty.
The preceding analysis focuses on discard rates as a tool that
transplant programs can use to reduce risk of lower patient or organ
survival rates, and hence risk of closure under the 2007 rule. A second
tool that a transplant program can use to reduce its risk of lower
overall patient survival rates is to remove patients who are slightly
less likely to survive from its waiting list, most commonly by making a
judgmental decision that the patient is ``too sick for
transplantation.'' Programs that are on the margin of receiving
regulatory sanctions, or that have received such sanctions already, are
particularly likely to exercise such judgments to reduce regulatory
risk. Several studies have estimated specific numbers of transplant
reductions due to the 2007 rule by comparing the number of patients
removed from the waiting list at programs that have received regulatory
sanctions to those that have not. To provide a baseline, these studies
make the conservative assumption that those programs with zero
sanctions have not removed any patients from their transplant waiting
list in order to avoid sanctions. For kidneys, one study estimated that
in the seven year period from 2007 to 2014, the lower performing
programs removed from waiting lists over 2500 patients more than would
have been expected absent sanctions, an average of over 350 per year
(J.D. Schold et al., ``Association of Candidate Removals From the
Kidney Transplant Waiting List and Center Performance Oversight,''
American Journal of Transplantation 2016, 1276-1284). The implications,
for the present time, of wait list changes initiated in 2007 is
unclear. Increased mortality in 2007 among the very sick patients who
were dropped from the wait list would have freed up organs for 2007's
moderately sick patients; these patients otherwise would have declined
in health so as to be the very sick population in 2008. Thus the
absolute level of health in 2008 would have been relatively good, in
which case the phenomenon of patients being dropped from the wait list
might not have perpetuated into the future, leaving little or no scope
for benefits to be achieved now as a result of the proposed CoP
revision. (We note that one year, from 2007 to 2008, may be an
exaggeration as to the short-term nature of this wait list-related
effect, but a somewhat longer tapering period could still have reached
completion now, more than a decade after the implementation of the 2007
CoP, thus leaving little scope for benefits.) On the other hand, if the
sickest patients in 2008 were dropped based on their relative health
levels--in spite of their improved absolute health relative to the
sickest patients in 2007--there would be potential wait list-related
benefits from revising this CoP at the present time. The benefits of
shifting transplants to the sickest patients from relatively less sick
patients have not been quantified, but because the harm to the less
sick patients would need to be netted off the benefit to the sickest
patients, the per-transplant magnitude would be much lower than the
per-transplant benefits of avoided organ discards.
Another quantitative study of kidney transplant effects used a
similar methodology and estimated that as a result of the 2007 rule, in
2011 sanctioned programs performed 766 fewer kidney transplants than
would otherwise have been the case (Sarah L. White et al., ``Patient
Selection and Volume in the Era Surrounding Implementation of Medicare
Conditions of Participation for Transplant Programs,'' Health Services
Research, April 2015, 330-350). White et al.'s finding of reduced
transplant volumes at particular kidney transplant centers does not
necessarily indicate decreased transplant volumes overall, with the
authors stating that their aggregate results ``do not indicate that the
introduction of the [2007] CoPs has systematically reduced
opportunities for marginal candidates or that there has been a
systematic shift away from utilization of higher risk deceased donor
kidneys.'' In other words, regulatory sanctions could have triggered
behavioral responses by some patients, some transplant surgeons, or
some health insurance plans to shift patients away from these centers
(many insurers restrict coverage through ``centers of excellence''
programs). Schold et al. (2013) find additional support for this
phenomenon, describing their empirical result as follows: ``Among 203
[adult kidney transplant] centers, 46 (23%) were low performing (LP) .
. . Among LP centers, there was a mean decline in transplant volume of
22.4 cases compared to a mean increase of 7.8 transplants among other
centers.'' The estimated decrease per low-performing transplant center
is roughly three times the increase per other center, but there are
also roughly three times as many other centers as low-performing
centers; as such, the most straightforward interpretation of this paper
is that the same number of transplants is being concentrated in a
smaller number of transplant centers. This outcome could still have
real impacts, such as changes in travel time for patients, but although
these impacts are valid for inclusion in a regulatory impact
assessment, they would be much smaller in magnitude than the longevity
benefits emphasized elsewhere in this analysis.
A feature common to most of these studies that is that they use
data that are already several years old when the study is published,
both because of the usual publishing lag and because performance data
such as one-year survival rates necessarily make transplant program
results less timely. None of these studies covers the last two or three
years of transplant program performance. As a result, none of these
studies has been able to use actual data to assess the effects of the
May 13, 2016 CMS changes that slightly reduced the performance level
for finding a ``condition-level'' violation that threaten's program
closure. For recent reviews of potential effects of those changes see
B.L. Kasiske et al., ``Potential Implications of Recent and

[[Page 47739]]

Proposed Changes in the Regulatory Oversight of Solid Organ
Transplantation in the United States,'' Am J Transplant, December 2016,
16(12), 3371-3377, and Colleen Jay and Jesse Schold, ``Measuring
transplant center performance: The goals are not controversial but the
methods and consequences can be,'' Curr Transplant Rep, March 2017,
4(1), 52-58. Using past data to measure potential effects, these
studies predict little or no positive effect from the revised standards
(which both studies conclude will still mis-identify lower performing
programs), but cannot evaluate actual effects because post-issuance
evidence is not yet available. This may not be relevant policy-wise,
since we propose to eliminate those standards, but it is a key question
for estimating the remaining scope (if any) of CoP-associated
unnecessary organ discards, and it does flag the pervasive problem of
timeliness of data and timeliness of study findings.
There are several studies that make similar estimates for liver
transplant programs (for example, L.D. Buccini, et al., ``Association
Between Liver Transplant Center Performance Evaluations and Transplant
Volume,'' American Journal of Transplantation 2014, 2097-2105). This
study found a large difference in transplant volume between programs
rated as lower performing by the SRTR (average decrease of 39.9
transplants from 2007 to 2012) and those not receiving adverse SRTR
ratings (average increase of 9.3 transplants over the same period). The
27 lower performing centers thus reduced their total number of liver
transplants by over 1,000, and compared to the higher performing
centers the decrease was even larger. This study did not, however, tie
its estimates to the performance standards in the 2007 rule (which are
similar but not identical to SRTR standards), to sanctions under that
rule, or to specific center decisions, such as removing candidates from
the wait list. Hence, while it certainly contributes to the body of
scholarship indicating that since 2007 transplants have been performed
in a more concentrated set of programs, it does not appear to provide
direct estimates of the quantitative effects of the 2007 rule on
overall numbers of liver transplants.
Taking into account all the various uncertainties involved in these
studies, we do not believe that we can estimate the effects of the 2007
rule on numbers of transplantations for any organ other than kidneys,
and that even for kidneys there is no clear central estimate of likely
quantitative effects. The wide variation in published results, and the
disclaimers as to the various uncertainties involved, make a precise as
well as reliable estimate all but impossible and would render arbitrary
any non-zero lower bound estimate of health and longevity impacts. (As
noted above, however, even in the absence of health and longevity
effects, there may be other benefits, such as reduced travel costs, if
the proposed rule reduces concentration of transplants in a smaller
number of facilities.) Therefore, we have shown the effects of the
proposed change as ``not quantified.'' This is not unusual in
Regulatory Impact Analyses that address complex phenomena that cannot
be measured directly, or whose effects are intertwined with other
changing circumstances. That said, we welcome any additional
information that might allow a quantitative estimate in the final rule.
Every transplant quality organ that is used for transplantation
rather than discarded has a very high probability of substantially
extending the life of the recipient. There is a particularly extensive
literature on life expectancy before and after transplant, quality of
life, and cost savings for kidney patients. A literature synthesis on
``The Cost-Effectiveness of Renal Transplantation,'' by Elbert S.
Huang, Nidhi Thakur, and David O. Meltzer, in Sally Satel, When
Altruism Isn't Enough (AEI Press, 2008) found essentially universal
agreement that kidney transplants were not only substantially life
extending, but also cost reducing. The authors performed an extensive
literature search and found that from 1968 to 2007 seventeen studies
assessed the cost-effectiveness of renal transplantation. The authors
concluded that ``Renal transplantation . . . is the most beneficial
treatment option for patients with end-stage renal disease and is
highly cost-effective compared to no therapy. In comparison to
dialysis, renal transplantation has been found to reduce costs by
nontrivial amounts while improving health both in terms of the number
of years of life and the quality of those years of life'' (page 31).
More recent studies have reached similar conclusions, as have other
syntheses. For example, the ``Systematic Review: Kidney Transplantation
Compared with Dialysis in Clinically Relevant Outcome'' (M. Tonelli, N.
Wiebe, G. Knoll, A. Bello, S. Browne, D. Jadhov, S. Klarenbach, and J.
Gill, American Journal of Transplantation 2011: 2093-2109) focused on
life expectancy and quality of life. This article reviewed 110 studies,
and concluded that the vast majority showed major improvement in life
quality and reductions in mortality among transplant recipients
compared to those remaining on dialysis. The Annual Data Report of the
United States Renal Data System utilizes national data on ESRD, and
reports that deaths per 1,000 patient years are about 180 for dialysis
patients and about 32 for transplant recipients (see 2016 report,
volume 2, Figure i.13 and Tables H.4 and H.10; accessed at https://www.usrds.org/adr.aspx). There are similar data on other organs. For
example, in 1998, HHS published a final rule with comment period that
established governance procedures for the OPTN (63 FR 16296). In the
RIA for that rule, the Department estimated that ``the annual benefits
of organ transplantation include about eleven thousand lives vastly
improved by kidney transplantation, and another eight thousand lives
both vastly improved and prolonged by transplantation of other major
organs'' (63 FR 16323).
Even without a robust aggregate estimate of likely increases in
organ utilization as a result of this proposed regulatory change, the
potential benefits are very substantial. For each new kidney
transplantation, there would be an average of 10 additional life years
per transplant patient compared to those on dialysis (see Wolfe A. et
al., ``Comparisons of Mortality in All Patients on Dialysis, Patients
on Dialysis Awaiting Transplantation, and Recipients of a First
Cadaveric Transplant,'' NEJM, 1999, 341:1725-30; accessed at http://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article). Valuing
each year of life gained using a ``value of a statistical life year''
(VSLY) of $490,000 in 2014 dollars, the total benefits from each
additional transplantation in 2018 would be $4.9 million before
discounting and $4.4 million after inflating to 2016 dollars and
discounting at either 3 percent over the 10-year period (life-year
figure for 2014 from Office of the Assistant Secretary for Planning and
Evaluation, HHS, Guidelines for Regulatory Impact Analysis, 2016, page
21, accessed at https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis). The HHS methodology produces the same result at
either discount rate in order to reach the same predetermined ``real''
value. For an explanation and justification of this VSLY approach, see
Cass R. Sunstein, ``Lives, Life-Years, and Willingness to Pay,'' 104
Columbia Law Review [i] (2004).
Those HHS guidelines also explain in some detail the concept of
quality adjusted life years. The key point to understand is that these
are research-based estimates of the value that people

[[Page 47740]]

are willing to pay for life-prolonging and life-improving health care
interventions of any kind (see sections 3.2 and 3.3 of the HHS
Guidelines for a detailed explanation). The QALY amount used in any
estimate of overall benefits is not meant to be a precise estimate, but
instead is a rough statistical measure that allows an overall estimate
of benefits expressed in dollars.
An alternative and more sophisticated analysis would take into
account that the life-extending effect of a kidney transplant is not
its first effect, but typically follows a number of years off dialysis,
until the organ fails and the patient returns to dialysis or is
retransplanted. Such an analysis can be found in a recent study by P.J.
Held et al., ``A Cost-Benefit Analysis of Government Compensation of
Kidney Donors,'' American Journal of Transplantation, 2016, pages 877-
885 (plus 65 pages of supplementary details explaining all assumptions,
data sources, and calculations). The largest differences between the
base case estimated in that study and the preceding estimates is that
this RIA uses the considerably higher value of a statistical year of
life under HHS guidelines, and this RIA uses the full value of a
statistical life year without a ``quality'' adjustment for the added
years of life (we use QALYs only for the improved quality of life
during years that would otherwise be on kidney dialysis). Under such an
estimation approach, potential life-extending benefits could be
somewhat larger. For example, if the proposed reform increased the
number of life-extending kidney transplants by only 100 a year, and the
benefits of both additional life years and QALY gains were estimated at
$5.1 million per patient, its total annual benefits for kidney patients
would be approximately $510 million a year (100 x $5.1 million).
There are additional benefits from kidney transplantation. As
previously discussed, kidney transplants do reduce medical costs, with
``breakeven'' after about 5 years and net savings of several hundred
thousand dollars per patient. Other organ transplants create lesser or
no medical savings because the alternative is not dialysis. Clearly,
however, these kidney transplant savings are small in relation to the
life-extending benefits. We have not estimated medical savings or costs
for kidneys or other organs in this RIA because any such estimates
would depend on the number of additional transplants that we have not
estimated.
We welcome comments on the quantitative and non-quantitative
portions of the preceding discussion and seek any empirical evidence
that would allow robust estimates of benefits, and in particular robust
quantitative estimates of the number of patients deprived of
transplantation as a result of the 2007 rule, as currently implemented
to reflect the 2016 guidance, for each organ type. We also welcome
comments on whether we have accurately and reasonably summarized the
research evidence on the effects of the 2007 rules, particularly in the
light of the many other factors influencing transplantation trends and
performance.
We note that life-extending estimates are averages across patients
who vary widely in age, medical condition, and life expectancy, as well
as type of organ failure. For example, the sickest patients typically
have very low life expectancies without transplant, and hence stand to
gain the most years of life from a transplant. Partly offsetting this,
these same patients, on average, have slightly lower survival rates
post-transplant. Organ and patient survival issues are complex and
dealt with by detailed policies and procedures developed and used by
the transplant community under the auspices of the OPTN. These policies
are reviewed and revised frequently based on actual experience and
changing technology--over time the success rate from previously
marginal organs, and in older patients, have both increased
substantially. For purposes of this analysis, the proper measure is the
average gain across all patients who would receive transplants as a
result of eliminating the 2007 rule, net of these other factors.
There could be potential offsets to these calculated and
uncalculated benefits and cost reductions. However, the particular
regulatory requirements we propose to remove are unlikely to drive any
further significant increases in graft and patient survival. For renal
transplants, the expected 1-year graft and patient survival rates are
already at 95 percent or better. Transplant program outcomes will
continue to be monitored by the OPTN and programs that are not in
compliance with the OPTN outcomes are referred to their Membership and
Professional Standards Committee for quality improvement activities.
The SRTR also publishes detailed data on transplant program performance
that allows patients and their physicians to compare transplant
programs and this transparency creates pressures to maintain and
improve survival rates in order to attract these patients.
The current regulatory requirements for transplant centers, as
discussed in section II.E ``Transplant Centers'' of this proposed rule,
have created both positive and adverse incentives for transplant
programs, with unanticipated side effects on both utilization of
donated organs and the ability of the highest risk patients to obtain
transplants. We expect the proposed change to provide substantial net
benefits, particularly since other regulatory and informational
incentives remain in place.
We welcome comments on this analysis as well as information that
would enable a more robust quantitative analysis of the impacts of this
change and on any alternative reforms that might provide even higher
benefits.
6. Effects on HHAs
As of May 2017 there are 12,624 HHAs that participate in Medicare
and Medicaid. In the January 2017 HHA CoP final rule (82 FR 4149) we
estimated that compliance with the requirements at Sec. 484.50(a)(3)
related to providing oral notice of all rights to each patient would
impose a burden of 5 minutes per patient, or 330,246 hours of burden
nationwide at a cost of $80,030,370, annually. The cost estimate was
based on a $63 per hour estimate for the services of a RN as derived
from the BLS Occupational Handbook, 2014-2015 edition, including a 100
percent benefit and overhead package. Adjusted to reflect more updated
salary information, as described previously, we estimate that
compliance with this provision would impose a $91,786,974 burden, based
on a RN earning $69 per hour.
We propose to revise the verbal notification requirements to limit
them to those that are required by section 1891 of the Act. Limiting
the amount of information that is required to be provided orally will
reduce the time per patient that is required to comply with the revised
requirement. For purposes of this analysis only, we assume that
providing oral notice regarding financial liability only will require 2
minutes per patient, reducing burden by 60 percent. Based on this
assumption, this proposed change would reduce the burden of the patient
rights notification requirement by 198,148 hours (330,246 hours
originally estimated x 0.6) and $55,072,184 ($91,786,974 burden as
updated to reflect more recent salary estimates x 0.6).
We also propose two changes that do not have a savings estimate.
First, we propose to eliminate the requirement at Sec. 484.80(h)(3)
that the HHA conduct a full competency evaluation of deficient home
health aides, and replace it with a requirement to retrain the aide
regarding the identified deficient skill(s) and require the aide to
complete a competency evaluation related to those

[[Page 47741]]

skills. As we stated in the January 2017 HHA CoP final rule (82 FR
4575), it is standard practice within the HHA industry to supervise
home health aides, and the regulatory requirements for such supervision
do not impose any additional burden.
Second, we propose to remove the requirement at Sec. 484.110(e)
related to providing a requested copy of the clinical record at the
next home visit, while retaining the requirement to provide the record
within 4 business days. As stated in the January 2017 HHA CoP final
rule (82 FR 4568 and 4575), we believe that providing such information
to patients is a usual and customary practice that does not impose a
burden upon HHAs. As such, removing the ``next home visit'' timeframe
requirement would not result in a savings of burden hours or dollars.
We welcome public comment regarding these burden estimates, and
additional regulatory reforms to reduce the burden of the HHA CoPs.
7. Effects on CAHs
We propose to remove the requirement at Sec. 485.627(b)(1) for
CAHs to disclose to CMS its owners or those with a controlling interest
in the CAH or any subcontractor in which the CAH directly or indirectly
ha a 5 percent or more ownership interest in accordance with 42 CFR
part 420, subpart C. We discuss the economic impact of this provision
in the ICR section, which is estimated at $141,000 total for all CAHs.
We discussed the burden reduction for our proposed revision of the
``patient care policies'' requirements imposed on CAHs in the ICR
section of this rule, which is estimated at $2.5 million.
8. Effects on CORFs
We discussed the burden reduction for our proposed revision of the
``utilization review plan'' requirements imposed on CORFs in the ICR
section of this rule, which is estimated at $309,072.
9. Effects on CMHCs
We discussed the burden reduction for our proposed revision of
Sec. 485.914(d)(1) ``update of the comprehensive assessment''
requirements imposed on CMHCs in the ICR section, which is an estimated
savings of $152,464.
10. Effects on Portable X-Ray Services
At Sec. 486.104 we propose to revise the portable x-ray CfCs to
focus on the qualifications of the technologist performing the
diagnostic test. As of May 2017 there were approximately 500 Medicare-
participating portable x-ray suppliers employing an estimated 5,000
portable x-ray technologists. Hiring limited x-ray technologists or
those with State licensure would allow portable x-ray suppliers to fill
vacant positions at a lower hourly cost. Assuming a 10 percent annual
turnover rate, all technologists could be hired at the lower salary
over a period of 10 years. Limited x-ray technologists can be hired for
approximately $30 an hour ($62,400 per year), whereas, according to the
BLS, x-ray technologists with advanced certification (ARRT) are hired
at a rate of approximately $60 dollars per hour ($124,800 per year).
This creates a savings opportunity of $30 per hour, or $62,400 per
year, per technologist position. Based on an assumed 10 percent
turnover rate, or 500 positions filled in any given year, this change
would create a savings of $31,200,000 savings in the first year. We
believe that these savings would be increased every year as more
positions are filled at the lower salary rate.
We welcome public comment regarding these burden estimates, and
additional regulatory reforms to reduce the burden of the portable x-
ray CfCs.
11. Effects on RHCs and FQHCs
We discussed the burden reduction for our proposed revision of
Sec. 491.9(b)(4) ``review of patient care policies'' requirements
imposed on RHCs and FQHCs in the ICR section, which is an estimated
savings of $6.8 million. In addition, the burden reduction for our
proposed revision of Sec. 491.11(a) ``program evaluation''
requirements imposed on RHCs and FQHCs in the ICR section of this rule,
which is an estimated savings of $9.4 million.
12. Effects of Emergency Preparedness Requirements on Providers and
Suppliers
This proposed rule revises the emergency preparedness requirements
for Medicare and Medicaid participating providers and suppliers, as
discussed in detail in section II.M of this proposed rule. The proposed
modifications to the emergency preparedness requirements either
simplify the requirements, eliminate duplicative requirements, or
reduce the frequency in which providers would need to comply with the
emergency preparedness requirements. We estimate that the proposed
changes to the emergency preparedness requirements would accrue an
annual cost savings of $155 million in total. The potential, estimated
cost savings for each revised emergency preparedness requirement is
outlined in detail below. The methodology used to calculate the
economic impact and the costs associated with the proposed changes to
the emergency preparedness requirements is the same methodology used to
calculate the economic impact in the Emergency Preparedness final rule
(81 FR 63860).
At Sec. 482.15(a), (b), (c), and (d) for hospitals and parallel
regulatory citations for other facilities, we propose to allow
providers to review their program at least every 2 years. We discuss
the economic impact for this requirement in the ICR section of this
rule, which represents $94,312,719 in savings.
At Sec. 482.15(a)(4) for hospitals, and other parallel citations
for the facilities mentioned in section II.J.2 of this proposed rule,
we propose to eliminate the requirement that facilities document
efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials and that facilities document
participation in collaborative and cooperative planning efforts. We
discuss the economic impact for this requirement in the ICR section of
this rule, which represents $7,179,117 in savings.
At Sec. 482.15(d)(1)(ii) for hospitals, and other parallel
citations for other facilities mentioned in section II.J.2 of this
proposed rule, we propose to require that facilities provide training
biennially, or every 2 years, after facilities conduct initial training
on their emergency program. In addition, we propose to require
additional training when the emergency plan is significantly updated.
We discuss the economic impact for this requirement in the ICR section
of this rule, which represents $33,267,864 in savings. Finally, at
Sec. 482.15(d)(2), we propose to require that providers of inpatient
services mentioned in section II.J.2 of this proposed rule conduct two
testing exercises annually, one of which may be an exercise of their
choice that must be either a community-based full-scale exercise (if
available), an individual facility-based functional exercise, a drill,
a tabletop exercise or workshop that includes a group discussion led by
a facilitator. We propose to require that providers of outpatient
services mentioned in section II.J.2 of this proposed rule conduct one
testing exercise annually which must be either a community-based full-
scale exercise (if available) or an individual facility-based
functional exercise every other year, and in the opposite years, may be
either a community-based full-scale exercise (if available), a
facility-based functional exercise, a drill, or a tabletop exercise or
workshop that includes a group discussion led by a facilitator. We

[[Page 47742]]

discuss the majority of this economic impact for this requirement in
the ICR section, which represents $9,117,425 in savings. We do not
estimate any economic impact for the providers of inpatient services as
we are not proposing any changes to the number of testing exercises
that must be conducted by these providers; however, we estimate an
additional economic impact for this provision for each outpatient
provider due to a reduction in the testing requirement from two
exercises per year to one exercise per year. We would like to note that
for CORFs and Organizations, consistent with the Emergency Preparedness
Final Rule (Medicare and Medicaid Programs; Emergency Preparedness
Requirements for Medicare and Medicaid Participating Providers and
Suppliers; Final Rule, 81 FR 63860), the CoPs for these providers
previously required them to have ongoing drills and exercises to test
their disaster plans. Therefore, we continue to expect, as we did in
the Emergency Preparedness final rule, that the economic impact to
comply with this requirement will be minimal, if any. Therefore, the
total economic impact of this provision for CORFs and Organizations
will be limited to the estimated ICR burden of $55,272 and $305,172,
respectively.
We estimate a total impact savings of $10,997,373 for this proposed
change. With an estimated ICR savings of $9,117,425, we estimate that
the total economic impact of this rule for the affected providers will
be $20,114,798. We list a summary of the calculation for the impact
savings accrued by removing this requirement for each facility in Table
15, based on facility numbers available as of May 2017.
ASCs: Combined total savings of $1,967,178 for 5,557 ASCs
((4 hours for an administrator at $108 per hour plus 4 hours for a
registered nurse at $69 per hour) x 5,557 ASCs x 50 percent).
Outpatient Hospice: Combined total savings of $1,405,920
((4 hours for an administrator at $105 per hour plus 4 hours for a
registered nurse at $69 per hour) x 4,040 outpatient hospices x 50
percent).
PACE: Combined total savings of $16,077 ((1 hour home for
a care coordinator at $69 per hour plus 1 hour for a quality
improvement nurse at $69) x 233 PACEs x 50 percent).
HHAs: Combined total savings of $2,632,104 ((2 hours for
an administrator at $105 per hour plus 3 hours for a director of
training at $69 per hour) x 12,624 HHAs x 50 percent).
CMHCs: Combined total savings of $58,926 ((5 hours for an
administrator at $105 per hour plus 3 hours for a nurse at $69 per
hour) x 161 CMHCs x 50 percent).
OPOs: Combined total savings of $5,046 ((1 hour for a QAPI
Director at $105 per hour plus 1 hour for an education coordinator at
$69 per hour) x 58 OPOs x 50 percent).
RHCs/FQHCs: Combined total savings of $ 4,187,832 (((4
hours for an administrator at $105 per hour plus 4 hours for a
registered nurse at $69 per hour) x 4,160 RHCs x 50 percent) plus (4
hours for an administrator at $105 per hour plus 4 hours for a
registered nurse at $69 per hour) x 7,874 FQHCs x 50 percent).
ESRDs: Combined total savings of $724,290 ((1 hour for an
administrator at $105 per hour plus 1 hour for a nurse manager at $105
per hour) x 6,898 dialysis facilities x 50 percent).

Table 15--Cost Savings for Emergency Preparedness Testing
------------------------------------------------------------------------
Cost savings
Provider/supplier per provider/ Combined total
supplier savings
------------------------------------------------------------------------
ASCs.............................. $354 $1,967,178 for 5,557
ASCs.
Hospices (outpatient)............. 348 $1,405,920 for 4,040
outpatient hospice
facilities.
PACEs............................. 69 $16,077 for 233
PACEs.
HHAs.............................. 209 $2,632,104 for
12,624 HHAs.
CMHCs............................. 366 $58,926 for 161
CMHCs.
OPOs.............................. 87 $5,046 for 58 OPOs.
RHCs/FQHCs........................ 348 $4,187,832 for RHCs
and FQHCs
($1,447,680 for
4,160 RHCs and
$2,740,152 for
7,874 FQHCs).
ESRD Facilities................... 105 $724,290 for 6,898
dialysis
facilities.
------------------------------------------------------------------------

13. One-Time Implementation Costs
All of the changes presented above will necessarily have to be
read, and understood, and implemented by affected providers. This will
create one-time costs even though the underlying change reduces burden.
In most cases these costs will be very low, and may be as simple as
observing that a particular procedure will need only to be performed
once rather than twice a year, and changing the schedule accordingly.
In some cases, the facility will need to adjust in response to multiple
burden reduction changes. In still other cases, time will have to be
spent deciding how to change existing policy. For example, as discussed
previously, ASCs and hospital outpatient facilities will need to decide
whether and in what circumstances medical histories and physical
examinations will be required or encouraged as a matter of policy.
Rather than attempt to estimate these situational variables in detail
for each facility type, we believe it possible to make reasonable
overall estimates of these one-time costs, recognizing that there will
be considerable variations among provider types and among individual
providers.
In total, there are about 122 thousand affected entities, as shown
in the Table 17 that follows. We assume that on average there will be 1
hour of time spent by a lawyer, 2 hours of time by an administrator or
health services manager, and 2 hours of time by other staff (we assume
registered nurses or equivalent in wage costs) of each affected
provider to understand the regulatory change(s) and make the
appropriate changes in procedures. We further estimate that for one
tenth of these providers, 2 hours of physician time will be needed to
consider changes in facility policy. Average hourly costs for these
professions, with wage rates doubled to account for fringe benefits and
overhead costs, are $134 for lawyers, $105 for managers, $70 for
registered nurses, and $198 for physicians. These numbers are from BLS
statistics for 2016, at https://www.bls.gov/oes/2016/may/oes_nat.htm.
The estimated costs for an average provider would therefore be 1
hour at $134 and in total for the lawyers, 2 hours at $105 or $210 in
total for the managers, 2 hours at $69 or $138 in total for the other
staff, and two-tenths of 1

[[Page 47743]]

hour at $198 or $40 in total for the physicians. These one-time costs
add up to $522 per provider on average, and in total to about $64
million.

Table 16--One-Time Implementation Costs
------------------------------------------------------------------------
Number of
Provider type affected
providers
------------------------------------------------------------------------
Religious Nonmedical Health Care Institutions........... 18
Ambulatory Surgical Centers and hospital outpatient..... 10,587
Hospices................................................ 4,602
Hospitals............................................... 5,031
Transplant programs..................................... 750
Home Health Agencies.................................... 12,624
Critical Access Hospitals............................... 1,343
Comprehensive Outpatient Rehabilitation Facilities...... 188
Community Mental Health Centers......................... 52
Portable X-Ray Services................................. 500
Rural Health Clinics and Federally Qualified Health 12,034
Centers................................................
Emergency Preparedness of Providers and Suppliers....... 74,246
---------------
Total Number of Providers............................... 122,180
Average Cost Per Provider............................... $522
---------------
Total One-Time Cost................................. $63,777,960
------------------------------------------------------------------------

13. Effects on Small Entities, Effects on Small Rural Hospitals,
Unfunded Mandates, and Federalism
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that
almost all health care providers regulated by CMS are small entities as
that term is used in the RFA (including small businesses, nonprofit
organizations, and small governmental jurisdictions). The great
majority of hospitals and most other health care providers and
suppliers are small entities, either by being nonprofit organizations
or by meeting the SBA definition of a small business (having revenues
of less than $7.5 million to $38.5 million in any 1 year, varying by
type of provider and highest for hospitals). Accordingly, almost all of
the savings that this proposed rule would create will benefit small
entities. We note that individual persons are not small entities for
purposes of the RFA, and hence the life-extending transplantation
benefits of the proposed rule are not relevant to the RFA.
The RFA requires that a Regulatory Flexibility Analysis (RFA) be
prepared if a proposed rule would have a ``significant impact on a
substantial number'' of such entities. HHS interprets the statute as
mandating this analysis only the impact is adverse, though there are
differing interpretations. Regardless, there is no question that this
proposed rule would affect a ``substantial number'' of small entities.
As shown in Table 17, the total number of affected entities will be
about 122,000, including those affected by more than one provision. The
rule of thumb used by HHS for determining whether an impact is
``significant'' is an effect of 3 percent or more of annual revenues.
These savings do not approach that threshold. Hospitals account for
about one-third of all health care spending and even if all these
savings accrued to hospitals this threshold would not be approached.
Therefore, the Secretary has determined that this proposed rule will
not have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 603 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area and has fewer than 100 beds. For the
reasons previously given, the Secretary has determined that this
proposed rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2018, that
threshold is approximately $148 million. This proposed rule contains no
mandates that will impose spending costs on State, local, or tribal
governments, or on the private sector. Indeed, it substantially reduces
existing private sector mandates.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications. This proposed rule imposes no such requirements.
Importantly, it would remove Federal requirements setting qualification
standards for hospice aides. Setting qualifications for health care
workers is traditionally a State function, and this change would
therefore remove an infringement on State prerogatives.
14. Effects on Costs to Facilities, Providers, Medicare, Other
Insurance, and Patients
Most of the individual proposals addressed in the preceding
analysis involve reducing burdensome costs on facilities, health care
professionals, and patients. Most of those reductions save time and
effort currently performed on tasks that we propose to eliminate or
reform and those reductions will result ultimately in reduced medical
care costs in these facilities, some of which will result in further
effects on public and private insurance costs. In this regard, it is
important to emphasize that the CoPs and CfCs generally apply to all
patients served by a Medicare and/or Medicaid participating provider or
supplier, not just Medicare or Medicaid patients, and

[[Page 47744]]

to the entire operations of the provider. Revisions to those
requirements apply broadly to the entire health care system. We are
hopeful that cost reductions ultimately flow to reductions in charges,
to reductions in third party payments, and hence to reductions in
insurance costs and to those who pay those costs.
In total, we estimate that the approximately 40 specific provisions
summarized in Tables 1 and 2 that are not related to reductions in pre-
operative physical examinations and tests in outpatient surgery, or to
transplantation, will save facilities and other providers, insurers,
and patients about $669 million annually. The initial savings will
accrue primarily to providers. How much of these savings will flow to
insurers and patients depends primarily on the payment and
reimbursement mechanisms in place for each affected entity for those
particular costs. According to the National Health Expenditure
Accounts, approximate payer shares in 2016 were 11 percent for consumer
out of pocket, 35 percent for private health insurance, 21 percent for
Medicare, 18 percent for Medicaid, and 15 percent for other public and
private payers such as the Department of Veteran Affairs and the
Department of Defense. We would expect savings to approximate these
shares. Ultimately, all costs are paid by workers and taxpayers who pay
for all health care directly or indirectly, quite apart from immediate
cost subsidies or cost sharing.
Two provisions directly reduce Medicare and other insurance costs.
Eliminating unnecessary patient history and physical examinations and
medical tests for procedures (such as cataract surgery) performed in
ASCs and in hospital outpatient surgery will disproportionately reduce
Medicare costs, since use of these services rises with age. Additional
transplantation of kidneys will reduce Medicare's ESRD costs, partially
offset by increased transplantation costs. Because of the difficulty in
finding evidence of the volume of such savings, we cannot estimate the
likely effects on Medicare spending.
Most of the facility and provider savings will accrue to Medicare
and other insurers over time as payment rate increases are slightly
reduced, and the remainder will accrue to other payers and to patients.
The following table shows our estimates of savings by major burden
reduction category and by type of payer.

Table 17--Savings by Major Payer Categories
[$ Millions]
----------------------------------------------------------------------------------------------------------------
Ambulatory All other cost
Savings to: surgery Transplant programs reductions Total
----------------------------------------------------------------------------------------------------------------
Medicare.............................. 123 not estimated........... 141 264
Medicaid.............................. 57 not estimated........... 120 177
Private Insurance..................... 110 not estimated........... 234 344
Other Payers.......................... 47 not estimated........... 100 147
Patients.............................. 117 not estimated........... 74 191
-------------------------------------------------------------------------
Total............................. 454 not estimated........... 669 1,123
----------------------------------------------------------------------------------------------------------------
Note: Calculations based largely on payer percentages in ``National Health Care Spending in 2016,'' Health
Affairs, January 2018, pages 150-160. Patient share for ambulatory surgery savings reflects travel time, not
medical costs.

15. Benefits to Patients
We discussed life-extending and life-saving benefits at length in
the analysis of increases in transplantation. These result from removal
of disincentives to transplant patients, or to use organs, where this
could reduce success rates by a few percent and possibly trigger
closure of transplant centers or programs under current rules. As
previously explained, we do not have robust estimates. There are
additional and substantial patient benefits likely to result from the
cost-reducing reforms that we propose. Time not wasted by medical care
providers or facilities on unnecessary tasks is time that can be used
to focus on better care. While such effects could be measured in
principal, there is little existing data on magnitudes of such effects.
We do, however, welcome public comments on these or any other aspects
of costs and benefits of the proposed rule.

D. Alternatives Considered

From within the entire body of CoPs and CfCs, we selected what we
believe to be the most viable candidates for reform as identified by
stakeholders, by recent research, or by experts as unusually
burdensome. This subset of the universe of standards is the focus of
this proposed rule. For all of the proposed provisions, we considered
not making these changes. Ultimately, we saw no good reasons not to
propose these burden reducing changes.
We welcome comments on whether we properly selected the best
candidates for change, and welcome suggestions for additional reform
candidates from the entire body of CoPs and other regulatory provisions
that fall directly on providers.

E. Uncertainty

Our estimates of the effects of this regulation are subject to
significant uncertainty. While the Department is confident that these
reforms will provide flexibilities to facilities that will yield major
cost savings, there are uncertainties about the magnitude of these
effects. Despite these uncertainties, we are confident that the rule
will yield substantial overall cost reductions and other benefits. In
this analysis we have provided estimates to suggest the potential
savings these reforms could achieve under certain assumptions. We
appreciate that those assumptions are simplified, and that actual
results could be substantially higher or lower. Although there is
uncertainty concerning the magnitude of all of our estimates, we do not
have the data to provide specific estimates for each reform proposed,
as to the range of possibilities, or to estimate all categories of
possible benefits, including health effects.

F. Accounting Statement and Table

As required by OMB Circular A-4 (available at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Table 18, we
have prepared an accounting statement showing the classification of the
transfers and costs associated with the various provisions of this
proposed rule.
While most provisions of the proposed rule have clearly predictable
effects we do not in most cases have detailed empirical information on
the precise magnitude of efforts involved (for example, time spent in
meeting paperwork or other administrative tasks

[[Page 47745]]

that apply to a particular provider type). Other provisions (notably
those related to organ transplantation and removal of strict H & P
requirements before ambulatory surgery) have even more uncertain effect
sizes. Therefore, we have estimated an upper and lower level for
benefit and cost reduction estimates that is 25 percent higher or lower
than our primary estimate for all quantified reforms other than those
related to ambulatory surgery, and in that area our lower bound is zero
cost reductions and our upper bound is a 50% reduction in H&P and
associated laboratory testing costs.

Table 18--Accounting Statement: Classification of Estimated Benefits and Savings
[$ Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary -----------------------------------------------------------------
Category estimate Lower bound Upper bound Year Discount
dollars rate (%) Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Life-Extending Benefits (monetized)............ Not Quantified
--------------------------------------------------------------------------------------------------------
Medical Cost Reduction Benefits (monetized).... Not Quantified
--------------------------------------------------------------------------------------------------------
Other Cost Reductions (monetized).............. -$1,240 -$580 -$1,890 2016 7 2018 onward.
-$1,250 -$590 -$1,900 2016 3 2018 onward.
--------------------------------------------------------------------------------------------------------
Costs.......................................... None
--------------------------------------------------------------------------------------------------------
Transfers...................................... None
--------------------------------------------------------------------------------------------------------------------------------------------------------

G. Reducing Regulation and Controlling Regulatory Costs

Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017 and requires that the
costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' This proposed rule
will, if finalized as proposed, be considered an E.O. 13771
deregulatory action. We estimate that this rule generates $1,051
million in annualized cost savings, discounted at 7 percent relative to
year 2018, over a perpetual time horizon. This estimate is based on
cost reductions starting at $1,123 million, and growing by $31 million
annually due to salary savings from X-ray technician turnover,
partially offset by one-time first-year implementation costs of $64
million, all in 2016 dollars. Details on the estimated cost savings
from this rule can be found in the preceding analysis. We note that
public comments and additional information may enable us to estimate
considerably larger savings from reforming H & P requirements for
ambulatory surgery or to narrow the uncertainty within the range of the
preliminary estimates.

H. Conclusion

This proposed rule would substantially reduce existing regulatory
requirements imposed on health care providers through the CoPs and
related regulatory provisions that Medicare and Medicaid providers must
meet. For some provisions, health benefits to patients will be
substantial and direct. Other provisions will free up time and efforts
of health care providers to focus on improving health care quality and
service delivery. Although this proposed rule does not require an
Initial Regulatory Flexibility Analysis, this regulatory impact
analysis, together with the remainder of this preamble, meets the
requirements for such an analysis. Furthermore, the analysis in this
section of the preamble, together with the remainder of this preamble,
provides a complete Regulatory Impact Analysis.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 403

Grant programs--health, Health insurance, Hospitals,
Intergovernmental relations, Medicare, Reporting and recordkeeping
requirements.

42 CFR Part 416

Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 418

Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 441

Aged, Family planning, Grant programs-health, Infants and children,
Medicaid, Penalties, reporting and recordkeeping requirements.

42 CFR Part 460

Aged, Health care, Health records, Medicaid, Medicare, Reporting
and recordkeeping requirements.

42 CFR Part 482

Grant program--health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 483

Grant programs--health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing home, Nutrition, Reporting
and recordkeeping requirements, Safety.

42 CFR Part 484

Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 485

Grant programs--health, Health facilities, Medicaid, Reporting and
recordkeeping requirements.

42 CFR Part 486

Grant programs--health, Health facilities, Medicare, Reporting and
recordkeeping requirements, X-rays.

42 CFR Part 488

Administrative practice and procedures, Health facilities, Health
professions, Medicare, reporting and recordkeeping requirements.

42 CFR Part 491

Grant programs--health, Health facilities, Medicaid, Medicare,

[[Page 47746]]

Reporting and recordkeeping requirements, Rural and Urban areas.

42 CFR Part 494

Health facilities, Diseases, Medicare, Reporting and recordkeeping
requirements.

For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 continues to read as follows:

Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 1395hh).

0
2. Section 403.736 is amended by--
0
a. Removing the introductory text;
0
b. Revising paragraph (a);
0
c. Removing paragraph (b); and
0
d. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
The revision reads as follows:

Sec. 403.736 Condition of participation: Discharge planning.

(a) Discharge planning and instructions. The RNHCI must have in
effect a discharge planning process that applies to all patients. The
process must assure that appropriate post-institution services are
obtained for each patient, as necessary. The RNHCI must assess the need
for a discharge plan for any patient likely to suffer adverse
consequences if there is no planning.
(1) Discharge instructions must be provided at the time of
discharge to the patient or the patient's caregiver as necessary.
(2) If the patient assessment indicates a need for a discharge
plan, the discharge plan must include instructions on post-RNHCI care
to be used by the patient or the caregiver in the patient's home, as
identified in the discharge plan.
(3) If the RNHCI's patient assessment does not indicate a need for
a discharge plan, the beneficiary or his or her legal representative
may request a discharge plan. In this case, the RNHCI must develop a
discharge plan for the beneficiary.
* * * * *
0
3. Section 403.748 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii); and
0
b. Adding paragraph (d)(1)(v).
The revisions and addition read as follows:

Sec. 403.748 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The RNHCI must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The RNHCI must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The RNHCI must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The RNHCI must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the RNHCI must conduct training on the updated
policies and procedures.
* * * * *

PART 416--AMBULATORY SURGICAL SERVICES

0
4. The authority citation for part 416 continues to read as follows:

Authority: Secs. 1102, 1138, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1320-8, and 1395hh) and section 371 of the Public
Health Service Act (42 U.S.C. 273)).

Sec. 416.41 [Amended]

0
5. Section 416.41 is amended by removing paragraph (b)(3).
0
6. Section 416.47 is amended by revising paragraph (b)(2) to read as
follows:

Sec. 416.47 Condition for coverage--Medical records.

* * * * *
(b) * * *
(2) Significant medical history and results of physical examination
(as applicable).
* * * * *
0
7. Section 416.52 is amended by revising the section heading and
paragraph (a) to read as follows:

Sec. 416.52 Condition for coverage--Patient admission, assessment
and discharge.

* * * * *
(a) Standard: Patient assessment and admission. (1) The ASC must
develop and maintain a policy that identifies those patients who
require a medical history and physical examination prior to surgery.
The policy must--
(i) Include the timeframe for medical history and physical
examination to be completed prior to surgery.
(ii) Address, but is not limited to, the following factors: Patient
age, diagnosis, the type and number of procedures scheduled to be
performed on the same surgery date, known comorbidities, and the
planned anesthesia level.
(iii) Follow nationally recognized standards of practice and
guidelines, and applicable State and local health and safety laws.
(2) Upon admission, each patient must have a pre-surgical
assessment completed by a physician who will be performing the surgery
or other qualified practitioner in accordance with applicable State
health and safety laws, standards of practice, and ASC policy.
(3) The pre-surgical assessment must include documentation of any
allergies to drugs and biologicals.
(4) The patient's medical history and physical examination (if any)
must be placed in the patient's medical record prior to the surgical
procedure.
* * * * *
0
8. Section 416.54 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).

[[Page 47747]]

The revisions and addition read as follows:

Sec. 416.54 Condition for coverage--Emergency preparedness.

* * * * *
(a) Emergency plan. The ASC must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The ASC must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The ASC must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The ASC must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the ASC must conduct training on the updated
policies and procedures.
(2) Testing. The ASC must conduct exercises to test the emergency
plan at least annually. The ASC must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, individual, a
facility-based functional exercise every 2 years. If the ASC
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the ASC is exempt from engaging in
its next required community-based or individual, facility-based
functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based, or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ASC's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
ASC's emergency plan, as needed.
* * * * *

PART 418--HOSPICE CARE

0
9. The authority citation for part 418 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).

0
10. Section 418.76 is amended by revising paragraph (a)(1)(iv) to read
as follows:

Sec. 418.76 Condition of participation: Hospice aide and homemaker
services.

* * * * *
(a) * * *
(1) * * *
(iv) A State licensure program.
* * * * *
0
11. Section 418.106 is amended by--
0
a. Removing paragraph (a)(1);
0
b. Redesignating paragraph (a)(2) as paragraph (a)(1);
0
c. Adding a new reserved paragraph (a)(2); and
0
d. Revising paragraph (e)(2)(i).
The revision reads as follows:

Sec. 418.106 Condition of participation: Drugs and biologicals,
medical supplies, and durable medical equipment.

* * * * *
(a) * * *
(2) [Reserved]
* * * * *
(e) * * *
(2) * * *
(i) Safe use and disposal of controlled drugs in the patient's
home. The hospice must have written policies and procedures for the
management, use, storage, and disposal of controlled drugs in the
patient's home. At the time when controlled drugs are first ordered the
hospice must:
(A) Provide information regarding the use, storage, and disposal of
controlled drugs to the patient or patient representative and family in
a format that is available on a continual basis;
(B) Discuss the information regarding the safe use, storage and
disposal of controlled drugs with the patient or representative, and
the family, in a language and manner that they understand to ensure
that these parties are effectively educated; and
(C) Document in the patient's clinical record that the information
was provided and discussed.
* * * * *
0
12. Section 418.112 is amended by adding paragraph (c)(10) and removing
paragraph (f) to read as follows:

Sec. 418.112 Condition of participation: Hospices that provide
hospice care to residents of a SNF/NF or ICF/IID.

* * * * *
(c) * * *
(10) A delineation of responsibilities for assuring orientation of
SNF/NF or ICF/IID staff furnishing care to hospice patients, to include
information regarding the hospice philosophy; hospice policies and
procedures regarding methods of comfort, pain control, and symptom
management; principles about death, dying, and individual responses to
death; patient rights; appropriate forms; and record keeping
requirements.
* * * * *
0
13. Section 418.113 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(iii);
0
b. Adding paragraph (d)(1)(vi);
0
c. Revising paragraph (d)(2); and
0
d. Adding paragraph (d)(3).
The revisions and addition to read as follows:

Sec. 418.113 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The hospice must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal,

[[Page 47748]]

regional, State, or Federal emergency preparedness officials' efforts
to maintain an integrated response during a disaster or emergency
situation.
(b) Policies and procedures. The hospice must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The hospice must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The hospice must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(iii) Provide emergency preparedness training at least every 2
years.
* * * * *
(vi) If the emergency preparedness policies and procedures are
significantly updated, the hospice must conduct training on the updated
policies and procedures.
(2) Testing for hospices that provide care in the patient's home.
The hospice must conduct exercises to test the emergency plan at least
annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the hospice
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the hospital is exempt from engaging
in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the actual
event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(3) Testing for hospices that provide inpatient care directly. The
hospice must conduct exercises to test the emergency plan twice per
year. The hospice must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise annually. If the hospice experiences
an actual natural or man-made emergency that requires activation of the
emergency plan, the hospice is exempt from engaging in its next
required full-scale community-based or individual, facility-based
functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation
of all drills, tabletop exercises, and emergency events and revise the
hospice's emergency plan, as needed.
* * * * *

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES

0
14. The authority citation for part 441 continues to read as follows:

Authority: Secs. 1102, 1902, and 1928 of the Social Security Act
(42 U.S.C. 1302).

0
15. Section 441.184 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 441.184 Emergency preparedness.

* * * * *
(a) Emergency plan. The PRTF must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The PRTF must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The PRTF must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The PRTF must develop and maintain an
emergency preparedness training program that is based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, policies and procedures at paragraph
(b) of this section, and the communication plan at paragraph (c) of
this section. The training and testing program must be reviewed and
updated at least every 2 years.
(1) * * *
(ii) After initial training, provide emergency preparedness
training every 2 years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the PRTF must conduct training on the updated
policies and procedures.
(2) Testing. The PRTF must conduct exercises to test the emergency
plan

[[Page 47749]]

twice per year. The PRTF must do the following:
(i) Participate in a full-scale exercise annually that is
community-based or when a community-based exercise is not accessible,
an individual, facility-based functional exercise annually. If the PRTF
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the PRTF is exempt from engaging in
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or
individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PRTF's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
PRTF's emergency plan, as needed.
* * * * *

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
16. The authority citation for part 460 continues to read as follows:

Authority: Secs: 1102, 1871, 1894(f), and 1934(f) of the Social
Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).

0
17. Section 460.84 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 460.84 Emergency preparedness.

* * * * *
(a) Emergency plan. The PACE organization must develop and maintain
an emergency preparedness plan that must be reviewed, and updated at
least every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The PACE organization must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
address management of medical and nonmedical emergencies, including,
but not limited to: Fire; equipment, power, or water failure; care-
related emergencies; and natural disasters likely to threaten the
health or safety of the participants, staff, or the public. Policies
and procedures must be reviewed and updated at least every 2 years. At
a minimum, the policies and procedures must address the following:
* * * * *
(c) Communication plan. The PACE organization must develop and
maintain an emergency preparedness communication plan that complies
with Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The PACE organization must develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan set forth in paragraph (a) of this section,
risk assessment at paragraph (a)(1) of this section, policies and
procedures at paragraph (b) of this section, and the communication plan
at paragraph (c) of this section. The training and testing program must
be reviewed and updated at lease every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the PACE must conduct training on the updated
policies and procedures.
(2) Testing. The PACE organization must conduct exercises to test
the emergency plan at least annually. The PACE organization must do the
following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the PACE
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the PACE is exempt from engaging in
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years opposite
the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
PACE's emergency plan, as needed.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
18. The authority citation for part 482 continues to read as follows:

Authority: Secs. 1102, 1871, and 1881 of the Social Security Act
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.

0
19. Section 482.15 is amended--
0
a. By revising paragraphs (a) introductory text, (a)(4), (b)
introductory text, (c) introductory text, (d) introductory text, and
(d)(1)(ii);
0
b. By adding paragraph (d)(1)(v);
0
c. By revising paragraph (d)(2);
0
d. In paragraph (g) introductory text, by removing the phrase
``transplant centers'' and adding into its place the phrase
``transplant programs''; and
0
e. In paragraphs (g)(1) and (2), by removing the phrase ``transplant
center'' and adding into its place the phrase ``transplant program''.
The revisions and addition read as follows:

Sec. 482.15 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The hospital must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to

[[Page 47750]]

maintain an integrated response during a disaster or emergency
situation.
(b) Policies and procedures. The hospital must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. At a minimum, the
policies and procedures must address the following:
* * * * *
(c) Communication plan. The hospital must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The hospital must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the hospital must conduct training on the
updated policies and procedures.
(2) Testing. The hospital must conduct exercises to test the
emergency plan at least twice per year. The hospital must do all of the
following:
(i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an
individual, facility-based functional exercise annually. If the
hospital experiences an actual natural or man-made emergency that
requires activation of the emergency plan, the hospital is exempt from
engaging in its next required full-scale community-based exercise or
individual, facility-based functional exercise following the onset of
the actual event.
(ii) Conduct an additional exercise at least annually that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospital's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
hospital's emergency plan, as needed.
* * * * *
0
20. Section 482.21 is amended by adding paragraph (f) to read as
follows:

Sec. 482.21 Condition of participation: Quality assessment and
performance improvement program.

* * * * *
(f) Standard: Unified and integrated QAPI program for multi-
hospital systems. If a hospital is part of a hospital system consisting
of multiple separately certified hospitals using a system governing
body that is legally responsible for the conduct of two or more
hospitals, the system governing body can elect to have a unified and
integrated QAPI program for all of its member hospitals after
determining that such a decision is in accordance with all applicable
State and local laws. The system governing body is responsible and
accountable for ensuring that each of its separately certified
hospitals meets all of the requirements of this section. Each
separately certified hospital subject to the system governing body must
demonstrate that:
(1) The unified and integrated QAPI program is established in a
manner that takes into account each member hospital's unique
circumstances and any significant differences in patient populations
and services offered in each hospital; and
(2) The unified and integrated QAPI program establishes and
implements policies and procedures to ensure that the needs and
concerns of each of its separately certified hospitals, regardless of
practice or location, are given due consideration, and that the unified
and integrated QAPI program has mechanisms in place to ensure that
issues localized to particular hospitals are duly considered and
addressed.
0
21. Section 482.22 is amended by--
0
a. Revising paragraphs (c)(5)(i) and (ii);
0
b. Adding paragraphs (c)(5)(iii), (iv), and (v); and
0
c. Removing paragraph (d).
The revisions and additions read as follows:

Sec. 482.22 Condition of participation: Medical staff.

* * * * *
(c) * * *
(5) * * *
(i) A medical history and physical examination be completed and
documented for each patient no more than 30 days before or 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, and except as provided under paragraph
(c)(5)(iii) of this section. The medical history and physical
examination must be completed and documented by a physician (as defined
in section 1861(r) of the Act), an oromaxillofacial surgeon, or other
qualified licensed individual in accordance with State law and hospital
policy.
(ii) An updated examination of the patient, including any changes
in the patient's condition, be completed and documented within 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, when the medical history and physical
examination are completed within 30 days before admission or
registration, and except as provided under paragraph (c)(5)(iii) of
this section. The updated examination of the patient, including any
changes in the patient's condition, must be completed and documented by
a physician (as defined in section 1861(r) of the Act), an
oromaxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy.
(iii) An assessment of the patient (in lieu of the requirements of
paragraphs (c)(5)(i) and (ii) of this section) be completed and
documented after registration, but prior to surgery or a procedure
requiring anesthesia services, when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at paragraph (c)(5)(v) of this
section, specific patients as not requiring a comprehensive medical
history and physical examination, or any update to it, prior to
specific outpatient surgical or procedural services. The assessment
must be completed and documented by a physician (as defined in section
1861(r) of the Act), an oromaxillofacial surgeon, or other qualified
licensed individual in accordance with State law and hospital policy.

[[Page 47751]]

(iv) The medical staff develop and maintain a policy that
identifies those patients for whom the assessment requirements of
paragraph (c)(5)(iii) of this section would apply. The provisions of
paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a
medical staff that chooses to maintain a policy that adheres to the
requirements of paragraphs of (c)(5)(i) and (ii) of this section for
all patients.
(v) The medical staff, if it chooses to develop and maintain a
policy for the identification of specific patients to whom the
assessment requirements in paragraph (c)(5)(iii) of this section would
apply, must demonstrate evidence that the policy applies only to those
patients receiving specific outpatient surgical or procedural services
as well as evidence that the policy is based on:
(A) Patient age, diagnoses, the type and number of surgeries and
procedures scheduled to be performed, comorbidities, and the level of
anesthesia required for the surgery or procedure.
(B) Nationally recognized guidelines and standards of practice for
assessment of specific types of patients prior to specific outpatient
surgeries and procedures.
(C) Applicable state and local health and safety laws.
* * * * *
0
22. Section 482.24 is amended by revising paragraphs (c)(4)(i)(A) and
(B) and adding paragraph (c)(4)(i)(C) to read as follows:

Sec. 482.24 Condition of participation: Medical record services.

* * * * *
(c) * * *
(4) * * *
(i) * * *
(A) A medical history and physical examination completed and
documented no more than 30 days before or 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services, and except as provided under paragraph (c)(4)(i)(C) of this
section. The medical history and physical examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(B) An updated examination of the patient, including any changes in
the patient's condition, when the medical history and physical
examination are completed within 30 days before admission or
registration, and except as provided under paragraph (c)(4)(i)(C) of
this section. Documentation of the updated examination must be placed
in the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(C) An assessment of the patient (in lieu of the requirements of
paragraphs (c)(4)(i)(A) and (B) of this section) completed and
documented after registration, but prior to surgery or a procedure
requiring anesthesia services, when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at Sec. 482.22(c)(5)(v), specific
patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical
or procedural services.
* * * * *
0
23. Section 482.42 is amended by adding paragraph (c) to read as
follows:

Sec. 482.42 Condition of participation: Infection control.

* * * * *
(c) Standard: Unified and integrated infection control program for
multi-hospital systems. If a hospital is part of a hospital system
consisting of multiple separately certified hospitals using a system
governing body that is legally responsible for the conduct of two or
more hospitals, the system governing body can elect to have a unified
and integrated infection control program for all of its member
hospitals after determining that such a decision is in accordance with
all applicable State and local laws. The system governing body is
responsible and accountable for ensuring that each of its separately
certified hospitals meets all of the requirements of this section. Each
separately certified hospital subject to the system governing body must
demonstrate that:
(1) The unified and integrated infection control program is
established in a manner that takes into account each member hospital's
unique circumstances and any significant differences in patient
populations and services offered in each hospital;
(2) The unified and integrated infection control program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration;
(3) The unified and integrated infection control program has
mechanisms in place to ensure that issues localized to particular
hospitals are duly considered and addressed; and
(4) A qualified individual (or individuals) with expertise in
infection prevention and control has been designated at the hospital as
responsible for communicating with the unified infection control
program, for implementing and maintaining the policies and procedures
governing infection control as directed by the unified infection
control program, and for providing infection prevention education and
training to hospital staff.
0
24. Section 482.51 is amended by revising paragraphs (b)(1)(i) and (ii)
and adding paragraph (b)(1)(iii) to read as follows:

Sec. 482.51 Condition of participation: Surgical services.

* * * * *
(b) * * *
(1) * * *
(i) A medical history and physical examination must be completed
and documented no more than 30 days before or 24 hours after admission
or registration, and except as provided under paragraph (b)(1)(iii) of
this section.
(ii) An updated examination of the patient, including any changes
in the patient's condition, must be completed and documented within 24
hours after admission or registration when the medical history and
physical examination are completed within 30 days before admission or
registration, and except as provided under paragraph (b)(1)(iii) of
this section.
(iii) An assessment of the patient must be completed and documented
after registration (in lieu of the requirements of paragraphs (b)(1)(i)
and (ii) of this section) when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at Sec. 482.22(c)(5)(v), specific
patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical
or procedural services.
* * * * *
0
25. Section 482.58 is amended by--
0
a. Revising paragraph (b)(1);
0
b. Removing paragraph (b)(4);
0
c. Redesignating paragraphs (b)(5) through (8) as paragraphs (b)(4)
through (7); and
0
d. Revising newly redesignated paragraphs (b)(4) and (7).
The revisions read as follows:

Sec. 482.58 Special requirements for hospital providers of long-term
care services (``swing-beds'').

* * * * *

[[Page 47752]]

(b) * * *
(1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii),
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and
(17), and (g)(18) introductory text of this chapter).
* * * * *
(4) Social services (Sec. 483.40(d) of this chapter).
* * * * *
(7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b)
of this chapter).
0
26. Section 482.61 is amended by revising paragraph (d) to read as
follows:

Sec. 482.61 Condition of participation: Special medical record
requirements for psychiatric hospitals.

* * * * *
(d) Standard: Recording progress. Progress notes must be recorded
by the physician(s), psychologists, or other licensed independent
practitioner(s) responsible for the care of the patient as specified in
Sec. 482.12(c), nurse, social worker and, when appropriate, others
significantly involved in active treatment modalities. The frequency of
progress notes is determined by the condition of the patient but must
be recorded at least weekly for the first 2 months and at least once a
month thereafter and must contain recommendations for revisions in the
treatment plan as indicated as well as precise assessment of the
patient's progress in accordance with the original or revised treatment
plan.
* * * * *

Sec. 482.68 [Amended]

0
27. Section 482.68 is amended--
0
a. In the section heading by removing the phrase ``transplant centers''
and adding in its place the phrase ``transplant programs''; and
0
b. In the introductory text and in paragraph (b) by removing the phrase
``transplant center'' and adding in its place the phrase ``transplant
program''.
0
28. Section 482.70 is amended--
0
a. In the definition of ``Adverse event'' by removing the phrase
``transplant centers'' and adding in its place the phrase ``transplant
programs'';
0
b. By removing the definitions of ``Heart-Lung transplant center'' and
``Intestine transplant center'';
0
c. By adding the definitions of ``Heart-Lung transplant program'' and
``Intestine transplant program'' in alphabetical order;
0
d. By removing the definitions of ``Pancreas transplant center'' and
``Transplant center'';
0
e. By adding the definition of ``Pancreas transplant program'' in
alphabetical order; and
0
f. By revising the definition of ``Transplant program''.
The additions and revision read as follows:

Sec. 482.70 Definitions.

* * * * *
Heart-Lung transplant program means a transplant program that is
located in a hospital with an existing Medicare-approved heart
transplant program and an existing Medicare-approved lung program that
performs combined heart-lung transplants.
Intestine transplant program means a Medicare-approved liver
transplant program that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
* * * * *
Pancreas transplant program means a Medicare-approved kidney
transplant program that performs pancreas transplants alone or
subsequent to a kidney transplant as well as kidney-pancreas
transplants.
* * * * *
Transplant program means an organ-specific transplant program
within a transplant hospital (as defined in this section).

Sec. Sec. 482.72, 482.74, 482.78, and 482.80 [Amended]

0
29. In the following table, for each section and paragraph indicated in
the first two columns, remove the phrase indicated in the third column
each time it appears and add the reference indicated in the fourth
column:

[[Page 47753]]

Sec. 482.82 [Removed]

0
30. Section 482.82 is removed.

Sec. Sec. 482.90, 482.92, 482.94, 482.96, 482.98, 482.100, and
482.102 [Amended]

0
31. In the following table, for each section and paragraph indicated in
the first two columns, remove the phrase indicated in the third column
each time it appears and add the reference indicated in the fourth
column:

----------------------------------------------------------------------------------------------------------------
Section Paragraphs Remove Add
----------------------------------------------------------------------------------------------------------------
Sec. 482.90.................... Introductory text........ transplant center....... transplant program.
Sec. 482.90.................... Introductory text........ center.................. program.
Sec. 482.90.................... (a)(2)................... transplant center....... transplant program.
Sec. 482.90.................... (a)(4)................... transplant center....... transplant program.
Sec. 482.90.................... (b) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.92.................... Introductory text........ donor-beneficiary....... donor-recipient.
Sec. 482.92.................... Introductory text........ beneficiary............. recipient.
Sec. 482.92.................... Introductory text........ Transplant centers...... Transplant programs.
Sec. 482.92.................... Introductory text........ transplant center....... transplant program.
Sec. 482.92.................... (a)...................... transplant center....... transplant program.
Sec. 482.92.................... (a)...................... beneficiary............. recipient.
Sec. 482.92.................... (b)...................... beneficiary............. recipient.
Sec. 482.92.................... (b)...................... beneficiary's........... recipient's.
Sec. 482.94.................... Introductory text........ Transplant centers...... Transplant programs.
Sec. 482.94.................... Introductory text........ transplant center....... transplant programs.
Sec. 482.94.................... Introductory text........ the center also......... the program also.
Sec. 482.94.................... (a) introductory text.... transplant center's..... transplant program's.
Sec. 482.94.................... (a)(2)................... center.................. program.
Sec. 482.94.................... (b) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.94.................... (b)(2)................... center's................ program's.
Sec. 482.94.................... (b)(3)................... center's................ program's.
Sec. 482.94.................... (c) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.94.................... (c) introductory text.... center's waiting list... program's waiting list.
Sec. 482.94.................... (c)(2)................... transplant center....... transplant program.
Sec. 482.94.................... (c)(3) introductory text. transplant centers...... transplant programs.
Sec. 482.94.................... (d) introductory text.... transplant center....... transplant program.
Sec. 482.94.................... (d)(2)................... transplant center....... transplant program.
Sec. 482.94.................... (e)...................... Transplant centers...... Transplant programs.
Sec. 482.96.................... Introductory text........ Transplant centers...... Transplant programs.
Sec. 482.96.................... (a)...................... transplant center's..... transplant program's.
Sec. 482.96.................... (a)...................... beneficiary............. recipient.
Sec. 482.96.................... (a)...................... transplant center....... transplant program.
Sec. 482.96.................... (b) introductory text.... transplant center....... transplant program.
Sec. 482.96.................... (b)(2)................... transplant center....... transplant program.
Sec. 482.96.................... (b)(2)................... transplant center's..... transplant program's.
Sec. 482.98.................... Introductory text........ transplant center....... transplant program.
Sec. 482.98.................... Introductory text........ the center.............. the program.
Sec. 482.98.................... (a) (a) heading and transplant center....... transplant program.
introductory text.
Sec. 482.98.................... (a)(1)................... transplant center....... transplant program.
Sec. 482.98.................... (b) introductory text.... transplant center....... transplant program.
Sec. 482.98.................... (c) introductory text.... transplant center....... transplant program.
Sec. 482.98.................... (c)(2)................... transplant center....... transplant program.
Sec. 482.98.................... (d) introductory text.... transplant center....... transplant program.
Sec. 482.98.................... (d) heading.............. living donor advocate independent living donor
team. advocate team.
Sec. 482.98.................... (d)(1)................... living donor advocate... independent living donor
advocate.
Sec. 482.98.................... (d)(2) introductory text. living donor advocate independent living donor
team. advocate team.
Sec. 482.98.................... (d)(3) introductory text. living donor advocate independent living donor
team. advocate team.
Sec. 482.98.................... (e)...................... transplant center....... transplant program.
Sec. 482.98.................... (f)...................... transplant center....... transplant program.
Sec. 482.100................... ......................... transplant center....... transplant program.
Sec. 482.102................... Introductory text........ transplant center....... transplant program.
Sec. 482.102................... (a) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.102................... (a)(8)................... transplant center....... transplant program.
Sec. 482.102................... (a)(8)................... beneficiary's........... recipient's.
Sec. 482.102................... (b) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.102................... (b)(1)................... transplant center....... transplant program.
Sec. 482.102................... (b)(4)................... beneficiary............. recipient.
Sec. 482.102................... (b)(6)................... transplant center- transplant program-
specific. specific.
Sec. 482.102................... (b)(6)................... beneficiaries........... receipients.
Sec. 482.102................... (b)(6)................... center-specific outcomes transplant-specific
outcomes.
Sec. 482.102................... (b)(9)................... transplant center....... transplant program.
Sec. 482.102................... (b)(9)................... beneficiary's........... recipient's.
Sec. 482.102................... (c) introductory text.... Transplant centers...... Transplant programs.
Sec. 482.102................... (c) introductory text.... center's................ program's.
Sec. 482.102................... (c) introductory text.... center.................. program.
Sec. 482.102................... (c)(1) introductory text. transplant center....... transplant program.

[[Page 47754]]

Sec. 482.102................... (c)(1) introductory text. center's waiting list... program's waiting list.
Sec. 482.102................... (c)(2)(i)................ center's waiting list... program's waiting list.
Sec. 482.102................... (c)(2)(i)................ transplant center....... transplant program.
Sec. 482.102................... (c)(2)(ii)............... beneficiaries........... recipients.
Sec. 482.102................... (c)(2)(ii)............... center's waiting list... program's waiting list.
Sec. 482.102................... (c)(2)(ii)............... the center.............. the program.
Sec. 482.102................... (c)(2)(ii)............... center's termination of program's termination of
approval. approval.
Sec. 482.102................... (c)(3)................... transplant center's..... transplant program's.
Sec. 482.102................... (c)(3)................... the center.............. the program.
Sec. 482.102................... (c)(3)................... center's waiting list... program's waiting list.
Sec. 482.102................... (c)(3)................... transplant center....... transplant program.
----------------------------------------------------------------------------------------------------------------

0
32. Section 482.102 is further amended by revising paragraph (a)(5) to
read as follows:

Sec. 482.102 Condition of participation: Patient and living donor
rights.

* * * * *
(a) * * *
(5) National and transplant program-specific outcomes, from the
most recent SRTR program-specific report, including (but not limited
to) the transplant program's observed and expected 1-year patient and
graft survival, and national 1-year patient and graft survival;
* * * * *

Sec. 482.104 [Amended]

0
33. For Sec. 482.104, in the following table, for the heading and each
paragraph indicated in the first column, remove the phrase indicated in
the second column each time it appears and add the reference indicated
in the third column:

------------------------------------------------------------------------
Paragraphs Remove Add
------------------------------------------------------------------------
Section heading............. transplant centers.. transplant programs.
(a)......................... transplant centers.. transplant programs.
(a)......................... transplant center... transplant program.
(b)......................... transplant centers.. transplant programs.
(c)......................... transplant centers.. transplant programs.
------------------------------------------------------------------------

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
34. The authority citation for part 483 continues to read as follows:

Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).

0
35. Section 483.73 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 483.73 Emergency preparedness.

* * * * *
(a) Emergency plan. The LTC facility must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, or Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The LTC facility must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. At a minimum, the
policies and procedures must address the following:
* * * * *
(c) Communication plan. The LTC facility must develop and maintain
an emergency preparedness communication plan that complies with
Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The LTC facility must develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan set forth in paragraph (a) of this section,
risk assessment at paragraph (a)(1) of this section, policies and
procedures at paragraph (b) of this section, and the communication plan
at paragraph (c) of this section. The training and testing program must
be reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the LTC facility must conduct training on the
updated policies and procedures.
(2) Testing. The LTC facility must conduct exercises to test the
emergency plan at least twice per year, including unannounced staff
drills using the emergency procedures. The LTC facility must do the
following:
(i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an
individual, facility-based functional exercise annually. If the LTC
facility experiences an actual natural or man-made emergency that
requires activation of the emergency plan, the LTC facility is exempt
from engaging its next required a full-scale community-based or
individual, facility-based functional exercise following the onset of
the actual event.
(ii) Conduct an additional exercise at least annually that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by

[[Page 47755]]

a facilitator, using a narrated, clinically-relevant emergency
scenario, and a set of problem statements, directed messages, or
prepared questions designed to challenge an emergency plan.
(iii) Analyze the LTC facility's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the LTC facility's emergency plan, as needed.
* * * * *
0
36. Section 483.475 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 483.475 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The ICF/IID must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The ICF/IID must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The ICF/IID must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include the following:
* * * * *
(d) Training and testing. The ICF/IID must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years. The ICF/IID must meet the
requirements for evacuation drills and training at Sec. 483.470(i).
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the ICF/IID must conduct training on the updated
policies and procedures.
(2) Testing. The ICF/IID must conduct exercises to test the
emergency plan at least twice per year. The ICF/IID must do the
following:
(i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an
individual, facility-based functional exercise annually. If the ICF/IID
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the ICF/IID is exempt from engaging
in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the actual
event.
(ii) Conduct an additional exercise at least annually that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
ICF/IID's emergency plan, as needed.
* * * * *

PART 484--HOME HEALTH SERVICES

0
37. The authority citation for part 484 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)) unless otherwise indicated.

0
38. Section 484.50 is amended by removing and reserving paragraph
(a)(3) and revising paragraph (c)(7) introductory text to read as
follows:

Sec. 484.50 Condition of participation: Patient rights.

* * * * *
(c) * * *
(7) Be advised, orally and in writing, of--
* * * * *
0
39. Section 484.80 is amended by revising paragraph (h)(3) to read as
follows:

Sec. 484.80 Condition of participation: Home health aide services.

* * * * *
(h) * * *
(3) If a deficiency in aide services is verified by the registered
nurse or other appropriate skilled professional during an on-site
visit, then the agency must conduct, and the home health aide must
complete, retraining and a competency evaluation related to the
deficient skill(s).
* * * * *
0
40. Section 484.102 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, and (d) introductory text and the first
paragraph (d)(1)(ii);
0
b. Redesignating the second paragraph (d)(1)(ii) as paragraph
(d)(1)(iv);
0
c. Adding paragraph (d)(1)(v); and
0
d. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 484.102 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The HHA must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The HHA must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The HHA must develop and maintain an

[[Page 47756]]

emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The HHA must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the HHA must conduct training on the updated
policies and procedures.
(2) Testing. The HHA must conduct exercises to test the emergency
plan at least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the HHA
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the HHA is exempt from engaging in
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
HHA's emergency plan, as needed.
* * * * *
0
41. Section 484.110 is amended by revising paragraph (e) to read as
follows:

Sec. 484.110 Condition of participation: Clinical records.

* * * * *
(e) Standard: Retrieval of clinical records. A patient's clinical
record (whether hardcopy or electronic form) must be made available to
a patient, free of charge, upon request within 4 business days.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
42. The authority citation for part 485 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).

0
43. Section 485.66 is amended by revising the introductory text to read
as follows:

Sec. 485.66 Condition of participation: Utilization review plan.

The facility must have in effect a written utilization review plan
that is implemented annually, to assess the necessity of services and
promotes the most efficient use of services provided by the facility.
* * * * *
0
44. Section 485.68 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 485.68 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The CORF must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
* * * * *
(b) Policies and procedures. The CORF must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The CORF must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The CORF must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the CORF must conduct training on the updated
policies and procedures.
(2) Testing. The CORF must conduct exercises to test the emergency
plan at least annually. The CORF must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the CORF
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the CORF is exempt from engaging in
its next required community-based or individual, facility-based
functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or

[[Page 47757]]

(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CORF's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CORF's emergency plan, as needed.
* * * * *
0
45. Section 485.625 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 485.625 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The CAH must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The CAH must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The CAH must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The CAH must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the CAH must conduct training on the updated
policies and procedures.
(2) Testing. The CAH must conduct exercises to test the emergency
plan at least twice per year. The CAH must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise once per year. If the CAH
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the CAH is exempt from engaging in
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually, that may
include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CAH's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CAH's emergency plan, as needed.
* * * * *

Sec. 485.627 [Amended]

0
46. Section 485.627 is amended by removing and reserving paragraph
(b)(1).
0
47. Section 485.635 is amended by revising paragraph (a)(4) to read as
follows:

Sec. 485.635 Condition of participation: Provision of services.

(a) * * *
(4) These policies are reviewed at least biennially by the group of
professional personnel required under paragraph (a)(2) of this section
and updated as necessary by the CAH.
* * * * *
0
48. Section 485.645 is amended by--
0
a. Revising paragraph (d)(1);
0
b. Removing paragraph (d)(4);
0
c. Redesignating paragraphs (d)(5) through (9) as paragraphs (d)(4)
through (8), respectively; and
0
d. Revising newly redesignated paragraphs (d)(4) and (7).
The revisions read as follows:

Sec. 485.645 Special requirements for CAH providers of long-term care
services (``swing-beds'').

* * * * *
(d) * * *
(1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii),
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17),
(g)(18) introductory text, and (h) of this chapter).
* * * * *
(4) Social services (Sec. 483.40(d) of this chapter).
* * * * *
(7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b)
of this chapter).
* * * * *
0
49. Section 485.727 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(5), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 485.727 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The Organizations must develop and maintain an
emergency preparedness plan that must be reviewed and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(5) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
* * * * *
(b) Policies and procedures. The Organizations must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and

[[Page 47758]]

updated at least every 2 years. At a minimum, the policies and
procedures must address the following:
* * * * *
(c) Communication plan. The Organizations must develop and maintain
an emergency preparedness communication plan that complies with
Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The Organizations must develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan set forth in paragraph (a) of this section,
risk assessment at paragraph (a)(1) of this section, policies and
procedures at paragraph (b) of this section, and the communication plan
at paragraph (c) of this section. The training and testing program must
be reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the Organizations must conduct training on the
updated policies and procedures.
(2) Testing. The Organizations must conduct exercises to test the
emergency plan at least annually. The Organizations must do the
following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the Organizations
experience an actual natural or man-made emergency that requires
activation of the emergency plan, the organization is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the actual
event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the Organization's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise their emergency plan, as needed.
* * * * *
0
50. Section 485.914 is amended by revising paragraphs (d)(1) and (3) to
read as follows:

Sec. 485.914 Condition of participation: Admission, initial
evaluation, comprehensive assessment, and discharge or transfer of the
client.

* * * * *
(d) * * *
(1) The CMHC must update each client's comprehensive assessment via
the CMHC interdisciplinary treatment team, in consultation with the
client's primary health care provider (if any), when changes in the
client's status, responses to treatment, or goal achievement have
occurred and in accordance with current standards of practice.
* * * * *
(3) For clients that receive PHP services, the assessment must be
updated no less frequently than every 30 days.
* * * * *
0
51. Section 485.920 is amended by revising paragraphs (a) introductory
text, (a)(4), (b) introductory text, (c) introductory text, and (d) to
read as follows:

Sec. 485.920 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The CMHC must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The CMHC must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The CMHC must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The CMHC must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years. If the emergency
preparedness policies and procedures are significantly updated, the
CMHC must conduct training on the updated policies and procedures.
(1) Training. The CMHC must provide initial training in emergency
preparedness policies and procedures to all new and existing staff,
individuals providing services under arrangement, and volunteers,
consistent with their expected roles, and maintain documentation of the
training. The CMHC must demonstrate staff knowledge of emergency
procedures. Thereafter, the CMHC must provide emergency preparedness
training at least every 2 years.
(2) Testing. The CMHC must conduct exercises to test the emergency
plan at least annually. The CMHC must:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based every 2 years. If the CMHC experiences an actual natural
or man-made emergency that requires activation of the emergency plan,
the CMHC is exempt from engaging in its next required community-based
or individual, facility-based functional exercise following the onset
of the actual event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or

[[Page 47759]]

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS

0
52. The authority citation for part 486 continues to read as follows:

Authority: Secs. 1102, 1138, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public
Health Service Act (42 U.S.C 273).

0
53. Section 486.104 is amended by revising paragraph (a) to read as
follows:

Sec. 486.104 Condition for coverage: Qualifications, orientation and
health of technical personnel.

* * * * *
(a) Standard: qualifications of technologists. All operators of the
portable X-ray equipment meet the requirements of paragraph (a)(1) or
(2) of this section.
(1) Successful completion of a program of formal training in X-ray
technology at which the operator received appropriate training and
demonstrated competence in the use of equipment and administration of
portable x-ray procedures; or
(2) Successful completion of 24 full months of training and
experience under the direct supervision of a physician who is certified
in radiology or who possesses qualifications which are equivalent to
those required for such certification.
* * * * *
0
54. Section 486.106 is amended by revising paragraph (a)(2) to read as
follows:

Sec. 486.106 Conditions for coverage: Referral for service and
preservation of records.

* * * * *
(a) * * *
(2) Such physician or nonphysician practitioner's order meets the
requirements at Sec. 410.32 of this chapter, and includes a statement
concerning the condition of the patient which indicates why portable X-
ray services are necessary.
* * * * *
0
55. Section 486.360 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2)(i).
The revisions and addition read as follows:

Sec. 486.360 Condition for coverage: Emergency preparedness.

* * * * *
(a) Emergency plan. The OPO must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The OPO must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and, the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The OPO must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The OPO must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at every 2 years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the OPO must conduct training on the updated
policies and procedures.
(2) * * *
(i) Conduct a paper-based, tabletop exercise or workshop at least
annually. A tabletop exercise is a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan. If the OPO
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the OPO is exempt from engaging in
its next required testing exercise following the onset of the actual
event.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
56. The authority citation for part 488 continues to read as follows:

Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the
Social Security Act, unless otherwise noted (42 U.S.C 1302, 1320a-
7j, 1395aa, 1395bb, 1395hh and 1395ll).

Sec. 488.30 [Amended]

0
57. Section 488.30(a) is amended in the definition for ``Provider of
services, provider, or supplier'' by removing the phrase ``transplant
centers'' and adding in its place the phrase ``transplant programs''.
0
58. Section 488.61 is amended--
0
a. By revising the section heading;
0
b. In the introductory text by removing the phrase ``transplant
centers'' and adding in its place the phrase ``transplant programs'';
0
c. In paragraph (a) by removing the phrases ``centers'' and ``center''
each time they appear and adding in their place the phrases
``programs'' and ``program,'' respectively;
0
d. In paragraph (a)(2) by removing the phrases ``Scientific Registry of
Transplant Beneficiary (SRTR) center-specific'' and ``Scientific
Registry of Transplant Recipient (SRTR) program-specific'' and adding
in its place the phrase ``Scientific Registry of Transplant Recipient
(SRTR) program-specific'';
0
e. By revising paragraph (a)(5);
0
f. By removing paragraph (c);
0
g. By redesignating paragraphs (d) through (h) as paragraphs (c)
through (g), respectively;
0
h. By revising newly redesignated paragraphs (c), (d), (e) introductory
text, (e)(1) introductory text, (e)(1)(iv), (e)(3), and (f)(1)(i),
(ii), and (iii).
The revisions read as follows:

[[Page 47760]]

Sec. 488.61 Special procedures for approval and re-approval of organ
transplant programs.

* * * * *
(a) * * *
(5) If CMS determines that a transplant program has met the data
submission, clinical experience, and outcome requirements, CMS will
review the program's compliance with the conditions of participation
contained at Sec. Sec. 482.72 through 482.76 and Sec. Sec. 482.90
through 482.104 of this chapter using the procedures described in
subpart A of this part. If the transplant program is found to be in
compliance with all the conditions of participation at Sec. Sec.
482.72 through 482.104 of this chapter, CMS will notify the transplant
program in writing of the effective date of its Medicare-approval. CMS
will notify the transplant program in writing if it is not Medicare-
approved.
* * * * *
(c) Loss of Medicare approval. Programs that have lost their
Medicare approval may seek re-entry into the Medicare program at any
time. A program that has lost its Medicare approval must:
(1) Request initial approval using the procedures described in
paragraph (a) of this section;
(2) Be in compliance with Sec. Sec. 482.72 through 482.104 of this
chapter at the time of the request for Medicare approval; and
(3) Submit a report to CMS documenting any changes or corrective
actions taken by the program as a result of the loss of its Medicare
approval status.
(d) Transplant program inactivity. A transplant program may remain
inactive and retain its Medicare approval for a period not to exceed 12
months. A transplant program must notify CMS upon its voluntary
inactivation as required by Sec. 482.74(a)(3) of this chapter.
(e) Consideration of mitigating factors in initial approval survey,
certification, and enforcement actions for transplant programs--(1)
Factors. Except for situations of immediate jeopardy or deficiencies
other than failure to meet requirements at Sec. 482.80 of this
chapter, CMS will consider such mitigating factors as may be
appropriate in light of the nature of the deficiency and circumstances,
including (but not limited to) the following, in making a decision of
initial approval of a transplant program that does not meet the data
submission, clinical experience, or outcome requirements:
* * * * *
(iv) Program improvements that substantially address root causes of
graft failures or patient deaths, that have been implemented and
institutionalized on a sustainable basis, and that are supported by
outcomes more recent than the latest available SRTR report, for which
there is a sufficient post-transplant patient and graft survival period
and a sufficient number of transplants such that CMS finds that the
program demonstrates present-day compliance with the requirements at
Sec. 482.80(c)(2)(ii)(C) of this chapter;
* * * * *
(3) Timing. Within 14 calendar days after CMS has issued formal
written notice of a condition-level deficiency to the program, CMS must
receive notification of the program's intent to seek mitigating factors
approval, and receive all information for consideration of mitigating
factors within 120 calendar days of the CMS written notification for a
deficiency due to data submission, clinical experience or outcomes at
Sec. 482.80 of this chapter. Failure to meet these timeframes may be
the basis for denial of mitigating factors. CMS may permit an extension
of the timeline for good cause, such as a declared public health
emergency.
(f) * * *
(1) * * *
(i) Approve initial approval of a program's Medicare participation
based upon approval of mitigating factors.
(ii) Deny the program's request for Medicare approval based on
mitigating factors.
(iii) Offer a time-limited Systems Improvement Agreement, in
accordance with paragraph (g) of this section, when a transplant
program has waived its appeal rights, has implemented substantial
program improvements that address root causes and are institutionally
supported by the hospital's governing body on a sustainable basis, and
has requested more time to design or implement additional improvements
or demonstrate compliance with CMS outcome requirements. Upon
completion of the Systems Improvement Agreement or a CMS finding that
the hospital has failed to meet the terms of the Agreement, CMS makes a
final determination of whether to approve or deny a program's request
for Medicare approval based on mitigating factors. A Systems
Improvement Agreement follows the process specified in paragraph (g) of
this section.
* * * * *

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
59. The authority citation for part 491 continues to read as follows:

Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302); and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).

0
60. Section 491.9 is amended by revising paragraph (b)(4) to read as
follows:

Sec. 491.9 Provision of services.

* * * * *
(b) * * *
(4) These policies are reviewed at least biennially by the group of
professional personnel required under paragraph (b)(2) of this section
and reviewed as necessary by the RHC or FQHC.
* * * * *
0
61. Section 491.11 is amended by revising paragraph (a) to read as
follows:

Sec. 491.11 Program evaluation.

(a) The clinic or center carries out, or arranges for, a biennial
evaluation of its total program.
* * * * *
0
62. Section 491.12 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 491.12 Emergency preparedness.

* * * * *
(a) Emergency plan. The RHC or FQHC must develop and maintain an
emergency preparedness plan that must be reviewed and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The RHC or FQHC must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. At a minimum, the
policies and procedures must address the following:
* * * * *
(c) Communication plan. The RHC or FQHC must develop and maintain
an emergency preparedness communication plan that complies with

[[Page 47761]]

Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The RHC or FQHC must develop and maintain
an emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the RHC/FQHC must conduct training on the
updated policies and procedures.
(2) Testing. The RHC or FQHC must conduct exercises to test the
emergency plan at least annually. The RHC or FQHC must do the
following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based functional exercise every 2 years. If the RHC or FQHC
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the RHC or FQHC is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the actual
event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the RHC or FQHC's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the RHC or FQHC's emergency plan, as needed.
* * * * *

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
FACILITIES

0
63. The authority citation for part 494 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. l302 and l395hh).

0
64. Section 494.62 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(vii); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:

Sec. 494.62 Condition of participation: Emergency preparedness.

* * * * *
(a) Emergency plan. The dialysis facility must develop and maintain
an emergency preparedness plan that must be evaluated and updated at
least every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation. The dialysis facility must contact the local
emergency preparedness agency at least annually to confirm that the
agency is aware of the dialysis facility's needs in the event of an
emergency.
(b) Policies and procedures. The dialysis facility must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. These emergencies
include, but are not limited to, fire, equipment or power failures,
care-related emergencies, water supply interruption, and natural
disasters likely to occur in the facility's geographic area. At a
minimum, the policies and procedures must address the following:
* * * * *
(c) Communication plan. The dialysis facility must develop and
maintain an emergency preparedness communication plan that complies
with Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training, testing, and orientation. The dialysis facility must
develop and maintain an emergency preparedness training, testing and
patient orientation program that is based on the emergency plan set
forth in paragraph (a) of this section, risk assessment at paragraph
(a)(1) of this section, policies and procedures at paragraph (b) of
this section, and the communication plan at paragraph (c) of this
section. The training, testing, and patient orientation program must be
evaluated and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(vii) If the emergency preparedness policies and procedures are
significantly updated, the dialysis facility must conduct training on
the updated policies and procedures.
(2) Testing. The dialysis facility must conduct exercises to test
the emergency plan at least annually. The dialysis facility must do all
of the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual, a
facility-based functional exercise every 2 years. If the dialysis
facility experiences an actual natural or man-made emergency that
requires activation of the emergency plan, the ESRD is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the actual
event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group
discussion led by a facilitator, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the dialysis facility's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the dialysis facility's emergency plan, as needed.
* * * * *

[[Page 47762]]

Dated: August 6, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: August 9, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-19599 Filed 9-17-18; 11:15 am]
BILLING CODE 4120-01-P