[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Proposed Rules]
[Pages 65909-65926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27176]
[[Page 65909]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Chapter IV
[CMS-9070-P]
RIN 0938-AQ96
Medicare and Medicaid Program; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule identifies and proposes reforms in Medicare
and Medicaid regulations that CMS has identified as unnecessary,
obsolete, or excessively burdensome on health care providers and
beneficiaries. 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 providing high quality patient care. This is one of
several rules that we are proposing to achieve regulatory reforms under
Executive Order 13563 on Improving Regulation and Regulatory Review and
the Department's Plan for Retrospective Review of Existing Rules.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on December 23,
2011.
ADDRESSES: In commenting, please refer to file code CMS-9070-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four 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-9070-P, P.O. Box 8012,
Baltimore, MD 21244-1850.
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-9070-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Ronisha Davis, (410) 786-6882.
We have also included a subject matter expert and contact
information under the ``Provisions of the Proposed Regulations''
section for each provision set out in this 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 Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
In January 2011, the President issued Executive Order 13563,
``Improving Regulations and Regulatory Review.'' Section 6 of that
order requires agencies to identify rules that may be ``outmoded,
ineffective, insufficient, or excessively burdensome, and to modify,
streamline, expand, or repeal them in accordance with what has been
learned.'' In accordance with the Executive Order, the Secretary of the
Department of Health & Human Services (HHS) published on May 18, 2011,
a Preliminary Plan for Retrospective Review of Existing Rules (http://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system). As shown in the plan, the Centers for Medicare & Medicaid
Services (CMS) has identified many obsolete and burdensome rules that
could be eliminated or reformed to improve effectiveness or reduce
unnecessary red tape 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. CMS
has 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. CMS has also identified
non-regulatory changes to increase transparency and to become a better
business partner.
As explained in the plan, HHS is committed to the President's
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 objective is 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. Consistent with the commitment
to periodic review and to public participation, HHS will continue to
assess its existing significant regulations in accordance with the
requirements of Executive Order 13563.
[[Page 65910]]
HHS welcomes public suggestions about appropriate reforms. If, at any
time, members of the public identify possible reforms to streamline
requirements and to reduce existing burdens, HHS will give those
suggestions careful consideration. Therefore, along with this proposed
rule, we seek ideas from the public to help identify areas for possible
reform.
II. Provisions of the Proposed Regulations
The following is a description of each of the proposals set forth
in this proposed rule. We have grouped the proposals into three
categories--(1) Removes unnecessarily burdensome requirements; (2)
removes obsolete regulations; and (3) responds to stakeholder concerns.
There are 14 specific reforms included in this proposed rule. As noted
above, we seek comments on additional areas for future reforms in these
three areas or others.
A. Removes Unnecessarily Burdensome Requirements
The following proposals seek to provide some form of burden relief
to providers and suppliers by modifying, removing, or streamlining
current regulations that we have identified as excessively burdensome.
1. End-Stage Renal Disease (ESRD) Facilities (Sec. 494.60)
Current regulations at 42 CFR part 494 provide Conditions for
Coverage (CfCs) for Medicare-participating end-stage renal disease
(ESRD) facilities. Effective February 9, 2009, these regulations were
updated to include Federal Life Safety Code (LSC) provisions that we
applied to ESRD facilities to standardize CMS regulations across
provider types. When the new regulation was first promulgated, we
believed that standardized application of the LSC was desirable and
that the costs for ESRD facilities would not be excessive. However, we
have since determined that standardization may not be appropriate given
the non-residential and unique characteristics of ESRD facilities and
the increased burden created by these requirements without the
commensurate benefit. Chapters 20 and 21 of the National Fire
Protection Agency's (NFPA) 101 LSC, 2000 Edition, were incorporated by
reference in the ESRD regulations at Sec. 494.60(e).
When implemented, these Federal LSC regulations were found to
duplicate many provisions of already existing State and local fire
safety codes covering ESRD facilities. Although the State and local
codes protected patients from fire hazards, the NFPA 101 LSC
retroactively imposed some additional structural requirements. We
believe that some of these additional requirements, such as smoke
compartments (per section 20.3.7/21.3.7 of NFPA 101) are unnecessary
for most ESRD facilities. Smoke compartments, for example, are required
in hospital and ambulatory surgical centers where patients are
anesthetized, unconscious, or sleeping overnight. Smoke compartments
are unnecessary in ESRD facilities as these compartments support a
``defend in place'' fire strategy which assumes the occupants of a
location cannot immediately evacuate in case of fire. However, in
dialysis facilities, the evacuation process from fire is rapid
disconnection from the dialysis machine and a quick exit.
In retrospect, the additional structural requirements of NFPA 101
potentially could improve patient safety from fire in specific dialysis
facilities that pose a higher risk for life safety from fire by their
proximity to a potential fire source or their barriers to prompt
evacuation from fire. These higher risk locations are those dialysis
facilities that are adjacent to occupancies that contain ``industrial
high hazard contents'' and those facilities that do not have a readily
available exit to the outside for swift, unencumbered evacuation.
Data demonstrate that there is an extremely low risk of fire in
outpatient dialysis facilities, and there are no recorded patient
injuries or death due to fire in the 40 years of the Medicare ESRD
program. The Federal Emergency Management Agency's (FEMA) Topical Fire
Report Series (TFRS) documented the low fire risk of ESRD facilities,
which ranked lowest (0.1 percent) in fire incidence among all health
care facilities. (Medical Facility Fires, TFRS Volume 9, Issue 4). The
reason that the fire risk is so low in dialysis facilities is due to
the following combination of factors:
ESRD facilities do not have fire ignition sources commonly
found in other medical facilities, for example, cooking, anesthesia,
paint shops, or piped-in gases, and are generally configured with open
patient treatment areas providing exits directly to the outside;
Dialysis patients are not anesthetized and are required at
Sec. 494.60(d)(2) of the ESRD regulation to be trained in emergency
disconnect from their dialysis treatment and evacuation from the
building;
Section 494.60(d)(4) of the ESRD regulation requires that
staff be present in the patient treatment area at all times during
treatment and therefore immediately available to assist in emergency
evacuation.
While the risks of fire are very low in a dialysis facility, the
costs of complying with the Federal LSC requirements in dialysis
facilities are high. Through research discussed in the following
paragraph, CMS has learned that the actual costs for renovation and
construction necessary for compliance with the additional requirements
of NFPA 101 for dialysis facilities are considerable and profoundly
exceed the original government estimate of $1,960 as published in the
preamble to the new 2008 ESRD/LSC regulations.
To estimate the true costs for renovation and construction
necessary to comply with the requirements for NFPA 101, in June 2011,
CMS asked ESRD providers to provide estimates of the financial impact
of implementing four potentially-costly additional requirements of NFPA
101. They included smoke compartment barriers, occupancy separations,
hazardous area separations, and upgraded fire alarms. Owners of 3,756
of 5,600 existing certified dialysis facilities responded to the CMS
request for cost projections. The responders represented approximately
70 percent of existing dialysis facilities, including hospital-owned
facilities and those owned by small, medium, and large dialysis
organizations.
The data collected showed that approximately 50 percent (an
estimated 2,800) of the existing ESRD facilities would require
renovations or upgrading of at least one of the four elements to comply
with the requirements of NFPA 101. There are several reasons why, in
June 2011, approximately 50 percent of existing dialysis facilities had
not been renovated to comply with the February 2009 implementation
date. The primary reason is the pervasive inconsistency in knowledge,
interpretation, and application of NFPA 101 to ESRD facilities that we
have become aware of since the 2009 implementation date. There was a
high variability in the cost estimates submitted, ranging from a low of
$23,500 to a high of $222,000 for an existing facility which needed to
renovate, construct and upgrade all four components. The average per
facility cost estimates submitted for the additional structural
requirements of NFPA 101 are as follows:
Smoke compartments--$32,544.
Occupancy separation--$28,139.
Hazardous areas separation--$16,976.
The total average cost for a facility to meet all three would be
$77,659. We suspect that the variability of the estimates may be due to
different State
[[Page 65911]]
and local requirements already in existence, differences in contractor
costs, varying building characteristics (for example, age, size,
construction type), and the inconsistent interpretations and
applications of NFPA 101 that are prevalent across the nation. The wide
range of estimates makes it difficult to determine an average cost
related to implementation of NFPA 101. However, using the average costs
for the individual structural requirements listed above, if 50 percent
or 2,800 facilities required only renovation for hazardous area
separation, the savings would be $47.5 million. If 2,800 facilities
required renovation for all three structural requirements, the total
savings from the burden reduction at the average estimate for all three
would be $217 million.
These amounts represent a significant financial burden on
facilities, with little or no improvement in patient safety from fire
for a majority of them. Expenditures of this magnitude would likely
divert resources away from areas which do affect dialysis patient
safety, such as infection control and prevention.
The cost estimates do not account for the added burden that
renovation to comply with NFPA 101 would impose on dialysis patients
who must be relocated to other ESRD facilities for their treatments
during construction. Significant additional costs would also be
incurred by Federal government agencies and State Survey Agencies for
oversight activities of LSC surveys which often duplicate State LSC
surveys.
Based on information gained since publication of the updated ESRD
CfC, we have concluded that the enforcement of the Federal LSC
requirements of NFPA 101 add costs out of proportion to any added
protection that they may afford in dialysis facilities which are not at
higher risk of fire penetration from adjacent industrial ``high
hazard'' occupancies and where swift, unencumbered evacuation to the
outside is available. Therefore, we propose revising Sec. 494.60(e)(1)
to restrict mandatory compliance with the NFPA 101 LSC to those ESRD
facilities located adjacent to ``high hazardous'' occupancies and those
facilities whose patient treatment areas are not located at grade level
with direct access to the outside. This revision would retain the NFPA
101 LSC protections for those facilities in higher-risk locations while
relieving burden on those for whom the subdivision of building space
and other additional LSC requirements of NFPA 101 are unnecessary.
We intend to use the NFPA definition of ``high hazard occupancy''
found at A.3.3.134.8.2, Annex A, NFPA 101, Life Safety Code 2000, which
applies to ``occupancies where gasoline and other flammable liquids are
handled, used or stored under such conditions that involve possible
release of flammable vapors; where grain dust, wood flour or plastic
dusts, aluminum or magnesium dust, or other explosive dusts are
produced; where hazardous chemicals or explosives are manufactured,
stored, or handled; where cotton or other combustible fibers are
processed or handled under conditions that might produce flammable
flyings; and where other situations of similar hazard exist.''
We note that all ESRD facilities would still be required to comply
with State and local fire codes and safety standards under Sec.
494.20. We also propose revising Sec. 494.60(e)(2) to clarify which
ESRD facilities must use sprinkler-equipped buildings: those housed in
multi-story buildings of lesser fire protected construction types
(Types II(000), III(200), or V(000), as defined in NFPA 101), which
were constructed after January 1, 2008; and those housed in high rise
buildings over 75 feet in height. We note that this revision would not
change the meaning or intent of Sec. 494.60(e)(2), but instead would
clarify it. That provision states that dialysis facilities
participating in Medicare as of October 14, 2008, may continue to use
non-sprinklered buildings if such buildings were constructed before
January 1, 2008, and State law so permits.
The ESRD CfCs also address other topics related to fire and
building safety that will remain in place under our proposed revision.
These existing CfC requirements include specific rules on how to handle
chemicals related to the dialysis process, as well as general
requirements for appropriate training in emergency preparedness for the
staff and patients, including provisions for instructions on
disconnecting from the dialysis machine during an emergency and
instructions on emergency evacuation. We welcome comments from the
public on whether the other ESRD CfCs can be improved in a way that
minimizes provider burden while protecting patient safety or,
alternately, the extent to which remaining requirements are necessary
and appropriate for the care and safety of dialysis patients.
Similarly, we note that other CMS regulations include CfCs, and we seek
comments on whether we should revisit these or other regulatory
provisions or whether existing requirements are necessary and
appropriate.
Contact: Thomas Hamilton, 410-786-9493.
2. ASC Emergency Equipment
Section 1832(a)(2)(F)(i) of the Act specifies that Ambulatory
Surgical Centers (ASCs) must meet health, safety, and other
requirements specified by the Secretary in regulation in order to
participate in Medicare. The Secretary is responsible for ensuring that
the Conditions for Coverage (CfCs) and their enforcement are adequate
to protect the health and safety of all individuals treated by ASCs,
whether they are Medicare beneficiaries or other patients.
To implement the CfCs, we determine compliance through State survey
agencies that conduct onsite inspections using these requirements. ASCs
also may be deemed to meet Medicare standards if they are certified by
one of the national accrediting organizations whose standards meet or
exceed the CfCs. The ASC regulations were first published on August 5,
1982 (47 FR 34082). Most of the revisions since then have been payment
related with the exception of a final rule published on November 18,
2008 (73 FR 68502) that revised four existing health and safety CfCs
and created three new health and safety CfCs (42 CFR 416.41 through
416.43 and 416.49 through 416.52).
Sections 416.44(c)(1) through (c)(9) provide a detailed list of
specific emergency equipment that must be available to the ASC's
operating room, for example, emergency call system; oxygen; mechanical
ventilator assistance equipment including airways, manual breathing
bag, and ventilator; cardiac defibrillator; cardiac monitoring
equipment; tracheotomy set; laryngoscopes and endotracheal tubes;
suction equipment; and emergency medical equipment and supplies
specified by the medical staff. In recent years, we have learned from
the ASC community that some of this equipment is outdated, while other
equipment is not applicable to the emergency needs of all ASCs. The
emergency equipment CfC has not been revised since its inception in
1982. To ensure that no ASC is burdened with maintaining unnecessary
equipment, we are proposing to revise the requirements for this CfC.
We propose to remove the list of emergency equipment at Sec.
416.44(c)(1) through (c)(9) and propose at Sec. 416.44(c) to require
that ASCs, in conjunction with their governing body and the medical
staff, develop policies and procedures which specify the types of
emergency equipment that would be appropriate for the facility's
patient population, and make the items
[[Page 65912]]
immediately available at the ASC to handle inter- or post-operative
emergencies. We are also proposing that the emergency equipment
identified by the ASC meet the current acceptable standards of practice
in the ASC industry. We believe that these proposed changes would
enable ASCs to better meet current demands, while also ensuring ASCs
have the flexibility necessary to respond to emergency needs and
incorporate the use of modern equipment most suitable for the
procedures performed in the facility.
We note that a potential disadvantage of the approach we propose is
that, by allowing ASCs to identify the emergency equipment most
appropriate for each individual facility, there could be increased
variation in emergency preparedness between different ASCs, even among
ASCs that provide very similar services. We therefore invite comment on
our proposed approach and on any alternatives to our approach. An
example of such an alternative might be for us to categorize ASCs
according to the major services they provide (such as ASCs that
typically use general anesthesia), and then specify a minimum array of
equipment tailored to the various categories of risk.
Contact: Jacqueline Morgan, 410-786-4282.
3. Revocation of Enrollment and Billing Privileges in the Medicare
Program (Sec. 424.535)
On June 27, 2008, we published a final rule in the Federal Register
(73 FR 36448) entitled ``Medicare Program; Appeals of CMS or CMS
Contractor Determinations When a Provider or Supplier Fails to Meet the
Requirements for Medicare Billing Privileges.'' In that rule, we added
a new provision at Sec. 424.535(c) to provide that: ``After a
provider, supplier, delegated official, or authorizing official has had
their billing privileges revoked, they are barred from participating in
the Medicare program from the effective date of the revocation until
the end of the re-enrollment bar. The re-enrollment bar is a minimum of
1 year, but not greater than 3 years, depending on the severity of the
basis for revocation.'' The purpose of this provision was to prevent
providers and suppliers from being able to immediately re-enroll in
Medicare after their billing privileges were revoked.
Section 424.535(a)(1) and Sec. 424.535(c), respectively, provide
that--(1) Medicare billing privileges may be revoked when a provider or
supplier is determined not to be in compliance with our enrollment
requirements; and (2) a post-revocation re-enrollment bar of a minimum
of 1 year shall be imposed.
We believe that the re-enrollment bar is unnecessary in certain
situations. Accordingly, we propose to eliminate the re-enrollment bar
in instances when providers and suppliers have not responded timely to
requests for revalidation of enrollment or other requests for
information initiated by CMS. Specifically, we propose revising Sec.
424.535(c) to expressly provide that the re-enrollment bar would not
apply if the revocation is based solely upon the failure of a provider
or supplier to respond timely to a revalidation request or other
request for information. We believe that this change is appropriate
because the re-enrollment bar in such circumstances often results in
unnecessarily harsh consequences for the provider or supplier and
causes beneficiary access issues in some cases. We have learned of
numerous instances when the provider's failure to respond to a
revalidation request was unintentional; that is, the provider was not
aware of the request due to, for instance, misrouted mail or a clerical
mistake. This is different from other revocation reasons, which may be
more serious; for example, we revoke providers that have been excluded
from Medicare, Medicaid, or other Federal health care programs or that
have been convicted of a felony under Sec. 424.535(a)(2) and (a)(3),
respectively. Finally, there is another, less restrictive regulatory
remedy available for addressing a failure to respond timely to a
revalidation request. This remedy is discussed below in section
II.A.4.c.
Contact: Morgan Burns, 202-690-5145.
4. Deactivation of Medicare Billing Privileges (Sec. 424.540)
On April 21, 2006, we published a final rule in the Federal
Register (71 FR 20753) entitled ``Medicare Program; Requirements for
Providers and Suppliers to Establish and Maintain Medicare
Enrollment.'' As part of that rule, we established provisions for the
deactivation of Medicare billing privileges at Sec. 424.540.
a. Section 424.540(a)(1)
Section 424.540(a)(1) specifies that Medicare billing privileges
may be deactivated if Medicare claims are not submitted for 12
consecutive months. The purpose of this provision was to prevent
situations in which unused, idle Medicare billing numbers could be
accessed by individuals and entities to submit false claims. Currently,
Medicare provider or supplier enrollment billing privileges are
deactivated (made ineligible for Medicare billing purposes) for
providers or suppliers that have not submitted a Medicare claim for 12
consecutive months. If the deactivated provider does furnish services
and attempts to submit a claim after the date of deactivation, the
claim would be denied. Therefore, once deactivated, a new provider or
supplier enrollment application must be submitted and processed by the
Medicare contractor before the billing privileges can be reactivated.
We propose to revise Sec. 424.540(a) to apply only to those
providers and suppliers who do not submit a Form CMS-855I (the
enrollment form for individual physicians and non-physician
practitioners) to enroll in the Medicare program. Physicians and non-
physician practitioners are deactivated most often due to billing
inactivity. To reactivate their Medicare billing privileges, they must
resubmit an enrollment application.
We are most concerned with organizations that fail to submit a
claim within a 12-month period, since business organizations would
generally submit a claim on a more frequent basis. Conversely, we
believe that there are instances in which individual practitioners may
have a valid reason for not filing claims within a 12-month period. For
instance, the practitioner--(1) May be enrolled in Medicare, but
generally only treats non-Medicare patients; or (2) may have two
separately-enumerated practice locations listed on its Form CMS-855I,
yet typically only performs services at one of them.
Further, the 12-month deactivation and reactivation processes also
increase the workload and administrative costs of Medicare contractors.
Accordingly, our proposal to revise Sec. 424.540(a) would remove this
unnecessary burden without jeopardizing our ability to detect and
prevent fraud and abuse. We have issued guidance that requires our
contractors to conduct certain verification activities to guard against
physician and non-physician practitioner identity theft. We believe
that this would lessen the danger that the unused billing numbers of
these individuals would be accessed by others to submit false claims.
b. Section 424.540(a)(2)
Section 424.540(a)(2) specifies that a provider or supplier's
Medicare billing privileges may be deactivated if it fails to report a
change to its enrollment information within 90 calendar days or, for
changes in ownership or control, within 30 calendar days. We are not
proposing to alter this provision. We believe it is necessary for
providers and
[[Page 65913]]
suppliers to understand the importance of furnishing updated enrollment
information to the Medicare program, for incorrect or aged data can
lead to improper payments.
c. Section 424.540(a)(3)
We propose to add a new Sec. 424.540(a)(3) that would allow us to
deactivate, rather than revoke, the Medicare billing privileges of a
provider or supplier that fails to furnish complete and accurate
information and all supporting documentation within 90 calendar days of
receiving notification to submit an enrollment application and
supporting documentation, or resubmit and certify to the accuracy of
its enrollment information. Although the deactivated provider or
supplier would still have to submit a complete enrollment application
to reactivate its billing privileges, it would remain enrolled in
Medicare and would not be subject to other, ancillary consequences that
a revocation entails: for instance, a prior revocation must be reported
in section 3 of the Form CMS-855I application, whereas a prior
deactivation need not. In fact, it is for this reason that we believe
our proposal would reduce the burden on the provider and supplier
communities.
Contact: Morgan Burns, 202-690-5145.
5. Duration of Agreement for Intermediate Care Facilities for the
Intellectually Disabled (Referred to in Current Regulations as
Intermediate Care Facilities for the Mentally Retarded) (Sec. 442.15
Through Sec. 442.109)
As described elsewhere in this preamble, we are replacing the use
of the term ``mentally retarded'' with the term ``intellectually
disabled'' as described in this program, so we have used the new term
in these proposed provisions.
Section 1910 of the Act provides for the certification and approval
of Intermediate Care Facilities for the Intellectually Disabled (ICFs/
ID). Current regulations at Sec. 442.109 and Sec. 442.110 address
ICFs/ID provider agreements and limit the ICFs/ID provider agreements
under Medicaid to annual time limits. We propose to remove the time
limited agreements for ICFs/ID at Sec. 442.16. We also are proposing
to eliminate this requirement at Sec. 442.15, Sec. 442.109, and Sec.
442.110. We propose to replace the requirement with an open ended
agreement which, consistent with nursing facilities (NFs), would remain
in effect until the Secretary or a State determines that the ICF/ID no
longer meets the conditions of participation for ICFs/ID at subpart I
part 483.
Also, we are proposing to add a requirement that a certified ICF/ID
must be surveyed on average every 12 months with a maximum 15-month
survey interval. Current regulations at 42 CFR part 442 require that
ICFs/ID be surveyed for compliance with conditions of participation at
least every 12 months on a relatively fixed schedule. By contrast,
nursing homes must be surveyed for compliance with certification
standards at intervals of between 12 and 15 months. We anticipate the
proposed change in the certification period would have positive impacts
on the care provided in these facilities as well as the efficient and
effective operation of State survey agencies responsible for regulating
ICFs/ID. We also anticipate that the adoption of flexible survey
scheduling would encourage more consistent staffing at levels that
support certification standards.
In addition, State survey agency resources are strained by the
rigid timelines imposed in the current regulation. For example, if a
complaint results in an abbreviated survey 10 or 11 months into the
facility's certification period, the current regulation does not allow
the State agency to expand the complaint survey for the purpose of
completing the requirements of annual certification at the same time.
Instead, the State is required to conduct another full survey at 12
months, which is duplicative. More flexibility would allow States to
use their survey staff in a targeted fashion, allocating resources
where needed to assure resident safety and quality of care, rather than
being forced to meet rigid regulatory timelines that do not bear a
relationship to the needs of residents.
Contact: Thomas Hamilton, 410-786-9493.
B. Removes Obsolete or Duplicative Regulations or Provides Clarifying
Information
The following proposals seek to remove requirements in the Code of
Federal Regulations (CFR) that are no longer needed or enforced. We
have identified regulations that have become obsolete and need to be
updated.
1. OMB Control Numbers for Approved Collections of Information (Sec.
400.300 and Sec. 400.310)
Part 400 subpart C requires the collection and display of control
numbers assigned by the Office of Management and Budget (OMB) to
collections of information contained in CMS regulations. The chart at
Sec. 400.310 that displays the OMB control numbers has not been
updated since December 8, 1995. We believe that, it is no longer
necessary to maintain the chart, because an inventory of currently
approved CMS information collections, including OMB control numbers, is
displayed on a public Web site at http://www.reginfo.gov/public/do/PRAMain. The Web site provides more timely access to the OMB control
numbers for CMS information collection requests than the process of
publishing updates in the CFR. Also, as part of our quarterly notice of
CMS issuances, which is published each quarter in the Federal Register,
we will remind reviewers where they can find the most current list of
information collections and OMB control numbers. For these reasons, we
are proposing to remove and reserve subpart C since the content of the
information contained in this subpart is obsolete and more readily
available on the public Web site.
Contact: Ronisha Davis, 410-786-6882.
2. Removal of Obsolete Provisions Related to Initial Determinations,
Appeals, and Reopenings of Part A and Part B Claims and Entitlement
Determinations (Sec. 405.701 Through Sec. 405.877)
In this rule, we propose to remove the obsolete provisions
contained in 42 CFR part 405 subparts G and H governing initial
determinations, appeals, and reopenings of Part A and Part B claims,
and determinations and appeals regarding an individual's entitlement to
benefits under Part A and Part B of Medicare. Section 1869 of the Act
and 42 CFR part 405 subpart I set forth the current policies for such
determinations, appeals, and reopenings.
On November 15, 2002, we published a comprehensive proposed rule in
the Federal Register (67 FR 69312), entitled ``Changes to the Medicare
Claims Appeal Procedures,'' to implement the relevant claims and
appeals provisions contained in the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-
554). In this proposed rule, we established, in one location (part 405
subpart I), provisions governing all aspects of Part A and Part B
claims appeals. In 2003, the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173) made further
changes to the Medicare claims appeals process. On March 8, 2005, we
published an interim final rule with comment period in the Federal
Register (70 FR 11420) to implement provisions of the proposed
[[Page 65914]]
rule, and to explain how the recently enacted MMA provisions would be
implemented. On December 9, 2009, we published a final rule in the
Federal Register (74 FR 65296) entitled, ``Changes to the Medicare
Claims Appeal Procedures,'' responding to comments received on the
interim final rule implementing part 405 subpart I.
Part 405 subparts G and H contain the policies for initial
determinations, appeals, and reopenings of Medicare Part A and Part B
claims, before the effective date of BIPA (referred to as ``pre-BIPA
appeals''). In addition, part 405 subparts G and H contain provisions
regarding initial determinations and appeals with respect to an
individual's entitlement to Medicare Parts A and B. Under subparts G
and H, initial determinations and appeals with respect to an
individual's entitlement to Medicare Parts A and B were conducted by
the Social Security Administration (SSA) and governed by the provisions
set forth in 20 CFR part 404 subpart J. Under part 405 subpart I, we
explain that the SSA makes initial determinations regarding an
individual's entitlement to Medicare Parts A and B, and conducts
reconsiderations of those initial determinations, in accordance with 20
CFR part 404, subpart J (see 42 CFR 405.904). However, entitlement
appeals beyond the reconsideration level (that is, to an Administrative
Law Judge, the Medicare Appeals Council, or Federal District Court) are
governed by the appeals procedures set forth in part 405 subpart I.
The provisions in part 405 subpart I were intended to replace the
provisions in part 405 subparts G and H once all pre-BIPA appeals were
completed. However, we determined it was necessary to establish a
phased-in implementation approach for part 405 subpart I appeals, and
to maintain the existing provisions in subparts G and H until the
completion of all pre-BIPA appeals (see, 74 FR 11424). With the
publication of the December 9, 2009 final rule, some pre-BIPA appeals
had not been completed. Thus, we were unable to remove the appeals
provisions in subparts G and H at that time.
In this rule, we propose to remove the obsolete provisions since it
is our expectation that in the 6 years since publication of the March
8, 2005 interim final rule, any party with a pending pre-BIPA appeal
would have received an appeal decision or would have brought the
pending matter to our attention. We believe that removing these
regulations would eliminate any possible confusion among Medicare
beneficiaries, providers, suppliers, and their representatives with
respect to the applicable appeal rights and procedures. However, while
we believe that all pre-BIPA appeals have been processed, we cannot be
completely certain that no pending pre-BIPA appeals currently exist. In
order to ensure that parties receive due process for their claim
disputes, we propose that any newly identified pre-BIPA appeals be
handled under the current appeals provisions set forth in part 405
subpart I. (We note that all reopening actions, regardless of whether
the determination or decision was made under the pre-BIPA process,
initial determinations on claims, and, as explained above, initial
determinations and appeals with respect to Medicare entitlement, are
currently processed under the applicable procedures in part 405 subpart
I.) We believe that maintaining a separate pre-BIPA claim appeals
process in the unlikely event such an appeal is discovered is
inefficient and impracticable. Using the current appeals process under
subpart I, for all appeal requests filed on or after the effective date
of this rule, as finalized, would reduce potential confusion about
applicable appeal procedures, and would enable parties to take
advantage of the reduced decision-making timeframes and other process
improvements offered throughout part 405 subpart I (for example, panel
reviews during the Qualified Independent Contractor (QIC)
reconsideration process for claims denied as not medically reasonable
and necessary (see Sec. 405.968(c)), and the right to escalate cases
to the next level of appeal when the QIC, Administrative Law Judge
(ALJ) or Medicare Appeals Council does not issue a decision within the
applicable adjudication timeframe (see Sec. 405.970, Sec. 405.1104,
and Sec. 405.1132).
Table 1 below illustrates how we propose to process any pre-BIPA
Part A appeals identified after the effective date of this rule, as
finalized, under our current regulations at part 405 subpart I. If a
party demonstrates that they had requested reconsideration under part
405 subpart G, but did not receive a decision or dismissal, the party
would be entitled to request a redetermination, followed by a QIC
reconsideration, ALJ hearing, Medicare Appeals Council review, and
judicial review in accordance with the provisions in part 405 subpart
I. If a party demonstrates that they received a reconsideration
decision and requested an ALJ hearing under part 405 subpart G but did
not receive an ALJ hearing decision or dismissal, the party would be
entitled to request a QIC reconsideration, followed by an ALJ hearing,
Medicare Appeals Council review, and judicial review in accordance with
the provisions in part 405 subpart I. If a party demonstrates that they
received an ALJ hearing decision under subpart G, and requested but did
not receive a decision, dismissal or denial of review notice from the
Departmental Appeals Board, the party would be entitled to request
Medicare Appeals Council review under part 405 subpart I.
Table 1--Pre-BIPA Part A Appeals
------------------------------------------------------------------------
Appeal resumes at the
Pending Pre-BIPA level of appeal in part following level in part 405
405 subpart G subpart I
------------------------------------------------------------------------
Reconsideration (Sec. 405.710).......... Redetermination (Sec.
405.940).
ALJ Hearing (Sec. 405.720).............. QIC Reconsideration (Sec.
405.960).
Departmental Appeals Board Review (Sec. Medicare Appeals Council
405.724). Review (Sec. 405.1100).
------------------------------------------------------------------------
Table 2 below illustrates how we propose to process any pre-BIPA
Part B appeals identified after the effective date of this rule, as
finalized, under our current regulations at part 405 subpart I. If a
party demonstrates that they requested a carrier review of an initial
determination under subpart H, but did not receive a carrier review
determination or dismissal, the party would be entitled to request a
redetermination, followed by QIC reconsideration, ALJ hearing, Medicare
Appeals Council review and judicial review in accordance with the
provisions in part 405 subpart I. If a party demonstrates that they
received a carrier review determination and requested a carrier hearing
but did not receive a carrier hearing officer decision or dismissal
under subpart H, the party would be entitled to request a QIC
reconsideration followed by an ALJ hearing, Medicare Appeals Council
review and judicial review in accordance with the provisions in part
405 subpart I. If a party demonstrates that they received a carrier
hearing officer decision, and requested but did not receive an ALJ
hearing decision or dismissal under subpart H, the party would be
directed to request a QIC reconsideration, followed by an ALJ hearing,
Medicare Appeals Council review and judicial review in accordance with
the provisions in part 405 subpart I. Finally, if a party demonstrates
that they received an ALJ hearing decision under subpart H, and
requested but did not receive a decision, dismissal or denial of review
notice from the Departmental Appeals Board under subpart H, the party
would be
[[Page 65915]]
entitled to request Medicare Appeals Council review under part 405
subpart I.
We are proposing that parties seek a QIC reconsideration before
requesting and receiving a hearing before an ALJ under subpart I for
several reasons. First, we note that several subpart I procedural
requirements at the ALJ level of appeal are predicated on a QIC
conducting a reconsideration. For example, the right to request an ALJ
hearing under Sec. 405.1000 and Sec. 405.1002 is premised on a party
being dissatisfied with a QIC reconsideration decision. In addition,
under Sec. 405.966(a)(2) and Sec. 405.1028, absent a showing of good
cause, evidence not submitted before the issuance of the QIC
reconsideration by a provider, supplier, or beneficiary represented by
a provider or supplier would be excluded from consideration by the ALJ.
Thus, channeling appeals through the QIC reconsideration level would
ensure that parties are afforded an opportunity to submit relevant
evidence without having to demonstrate good cause for not submitting it
during the pre-BIPA process. Second, we believe channeling pre-BIPA
appeals through the QIC reconsideration process would benefit parties.
For example, we believe parties would benefit from the panel review by
physicians and other appropriate health care professionals at the QIC
level when claims are denied as not medically reasonable and necessary
under section 1862(a)(1)(A) of the Act. We also believe the
administrative record would be more fully developed with respect to the
medical and scientific evidence considered by such panels. Third, in
order for a party to seek expedited access to judicial review under
Sec. 405.990, the party must first have received a QIC
reconsideration, or the appeal must have been escalated from the QIC to
the ALJ level (see, Sec. 405.990(b)). To ensure a party may seek
expedited access to judicial review, if such review is appropriate, we
are proposing to channel pre-BIPA appeals through the QIC
reconsideration process when the party has not received an ALJ
decision. Finally, as noted above, we believe that having one set of
rules apply to all appeals would eliminate the confusion and
uncertainty regarding the appropriate procedures to follow should there
be any existing pre-BIPA appeals.
Table 2--Pre-BIPA Part B Appeals
------------------------------------------------------------------------
Appeal resumes at the
Pending pre-BIPA level of appeal in part following level in part 405
405 subpart H subpart I
------------------------------------------------------------------------
Review of Initial Determination (Sec. Redetermination (Sec.
405.807). 405.940).
Carrier Hearing (Sec. 405.821).......... QIC Reconsideration (Sec.
405.960).
ALJ Hearing (Sec. 405.855).............. QIC Reconsideration (Sec.
405.960).
Departmental Appeals Board Review (Sec. Medicare Appeals Council
405.856). Review (Sec. 405.1100).
------------------------------------------------------------------------
With very limited exceptions as noted below, the provisions in
subparts G and H related to the processing of initial determinations,
reopenings, and appeals of claims under Part A and Part B of Medicare,
and determinations and appeals regarding an individual's entitlement to
benefits under Part A and Part B of Medicare are obsolete because of
the new procedures set forth in subpart I. We propose to remove all
such obsolete provisions. The provisions in subparts G and H identified
below are either unrelated to claims or entitlement appeals and are
still in effect, or were inadvertently not included in subpart I, and
accordingly, would be retained and redesignated to subpart I.
We propose to retain Sec. 405.706, ``Decisions of utilization
review committees,'' and redesignate the section as Sec. 405.925 in
subpart I. This regulatory provision explains that--(1) The decisions
made by the utilization review committees are not initial
determinations made by the Secretary within the meaning of section 1869
of the Act; (2) are not subject to the appeal; and (3) further explains
how utilization review committee decisions may be used in payment and
coverage decisions. In drafting the regulations under part 405 subpart
I, we inadvertently omitted this section. For clarity, and to ensure
that beneficiaries and providers understand that utilization review
committee decisions are not appealable, and in furtherance of our goal
to include all relevant claims appeals procedures in one place, we are
proposing to retain Sec. 405.706, and redesignate it as Sec. 405.925.
In addition, we propose to retain Sec. 405.874, ``Appeals of CMS
or a CMS contractor,'' and redesignate the provisions as Sec. 405.800,
Sec. 405.803, Sec. 405.806, Sec. 405.809, Sec. 405.812, Sec.
405.815, and Sec. 405.818. These provisions set forth, among other
things, the procedures related to denials of provider or supplier
enrollment applications, revocations of Medicare provider or supplier
billing privileges, and the appeal rights afforded to the parties to
those determinations. As these procedures do not relate directly to
initial determinations and appeals of Medicare claims, they were not
included in part 405 subpart I. However, these provisions are not
obsolete and are still applicable to provider and supplier enrollment
actions. We also note that we are making minor technical edits to the
current text to refine the section.
Finally, we also propose to remove Sec. 405.753 and Sec. 405.877
(``Appeal of a categorization of a device.''). These regulations are
obsolete because they no longer comport with the definition of
``national coverage determination'' in section 1869(f) of the Act, as
amended by section 522 of BIPA. The Food and Drug Administration's
(FDA) categorization of a product as a category A device is not a
determination of whether or not the item is covered under title XVIII
of the Act. Under Sec. 405.203(c), we use the FDA categorization in
making a coverage decision. Thus, our decision (acting on the FDA's
categorization) to deny a claim for a category A device is an initial
determination that is subject to review through the claims appeals
process.
Contact: Flosetta Rowry, 410-786-8492.
3. ASC Infection Control Program (Sec. 416.44)
In existing regulations at 42 CFR 416.51, we require all ASCs to
adhere to regulations regarding Infection Control, which include the
requirement that all ASCs develop an infection control program. The
regulations also describe how ASCs must set up their infection control
program, such as the requirement that the ASC designate a qualified
professional who has training in infection control and the ASC's
obligation to establish a plan of action regarding preventing,
identifying, and managing infections and communicable diseases.
Current regulations also contain a provision for infection control
that is located within the physical environment standard in 42 CFR
416.44(a)(3). The requirement states that an ASC must establish a
program for identifying and preventing infections, maintaining a
sanitary environment, and reporting the results to the appropriate
authorities. This regulatory requirement was part of the original CfCs
first published for ASCs in 1982. Publication of the November, 2008 ASC
final rule elevated the infection control requirements from a standard
level under the Environment condition to a
[[Page 65916]]
separate condition level requirement, thus making the regulatory
requirement in the Environment CfC duplicative. The Infection Control
CfC located at Sec. 416.51 expands and broadens the infection control
requirements that were part of the original ASC requirements in the
Environment CfC. Therefore, we propose to remove the requirement at
Sec. 416.44(a)(3), located in the Environment CfC, as it is
unnecessary and obsolete. We believe this change would alleviate any
duplicative efforts and confusion regarding the infection control
requirements.
Contact: Jacqueline Morgan, 410-786-4282.
4. E-Prescribing (Sec. 423.160)
The MMA amended title XVIII of the Act to establish a voluntary
prescription drug benefit program. Under those provisions, prescription
Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations
offering Medicare Advantage-Prescription Drug Plans (MA-PD) are
required to establish electronic prescription drug programs to provide
for electronic transmittal of certain information to the prescribing
provider and dispensing pharmacy and pharmacist. This includes
information about eligibility, benefits (including drugs included in
the applicable formulary, any tiered formulary structure and any
requirements for prior authorization), the drug being prescribed or
dispensed and other drugs listed in the medication history, as well as
the availability of lower cost, therapeutically appropriate
alternatives (if any) for the drug prescribed. The MMA directed the
Secretary to promulgate uniform standards for the electronic
transmission of this data.
In the November 7, 2005, final rule (70 FR 67568), entitled
``Medicare Program; E-Prescribing and the Prescription Drug Program,''
CMS adopted three e-prescribing foundation standards to be used for e-
prescribing for the Medicare Part D program. The three foundation
standards are--(1) The National Council for Prescription Drug Programs
(NCPDP) SCRIPT version 5.0., which provides for communications between
the prescriber and dispenser; (2) the NCPDP Telecommunication Standard
Version 5 release 1 (NCPDP Telecom 5.1) and equivalent NCPDP Batch
Standard Batch Implementation Guide version 1.1 which is the
transaction between the dispenser and the Plan, and the ASC X12N 270/
271 Health Care Eligibility Benefit Inquiry and Response, Version 4010;
and (3) the Addenda to Health Care Eligibility Inquiry and Response,
Version 4010A1 (4010/4010A) for conducting eligibility and benefit
inquiries between the prescriber and Plan Sponsor. The latter two
transactions, NCPDP Telecom 5.1 and the 4010/4010A are also adopted as
HIPAA transaction standards.
In the November 7, 2005 final rule, we discussed the means for
updating the Part D e-prescribing standards. In instances in which an
e-prescribing standard has also been adopted as a HIPAA transaction
standard in 45 CFR part 162, the process for updating the e-prescribing
standard would have to be coordinated with the maintenance and
modification of the applicable HIPAA transaction standard. In the
January 16, 2009 final rule, entitled ``Health Insurance Reform;
Modifications to the Health Insurance Portability and Accountability
Act (HIPAA) Electronic Transaction Standards'' (74 FR 3296), we revised
Sec. 162.1102, Sec. 162.1202, Sec. 162.1302, Sec. 162.1402, Sec.
162.1502, Sec. 162.1602, Sec. 162.1702, and Sec. 162.1802 to adopt
the ASC X12 Technical Reports Type 3, Version 005010 (Version 5010), as
a replacement of the current X12 Version 4010 and 4010A1 standards
(Version 4010/4010A). Covered entities conducting HIPAA standards are
required to use Version 5010 by January 1, 2012. The complete
discussion of these standards may be found in the January 16, 2009
final rule (74 FR 3296).
In the same final rule, effective January 1, 2012, we revised Sec.
162.1102, Sec. 162.1202, Sec. 162.1302, and Sec. 162.1802 by adding
a new paragraph (c) to each of these sections to adopt the NCPDP
Telecommunication Standard Implementation Guide, Version D, Release 0
and equivalent NCPDP Batch Standard Implementation Guide, Version 1,
Release 2 (collectively, Version D.0) in place of the NCPDP
Telecommunication Standard Implementation Guide, Version 5, Release 1
and equivalent NCPDP Batch Standard Batch Implementation Guide, Version
1, Release 1 (collectively, Version 5.1), for the following retail
pharmacy drug transactions: health care claims or equivalent encounter
information; eligibility for a health plan; referral certification and
authorization; and coordination of benefits.
Therefore, for consistency with the current HIPAA transaction
standards, and the need for covered entities (prescribers and
dispensers) to comply with HIPPA, we propose to revise Sec.
423.160(b)(3), to--(1) Update Version 4010/4010A with Version 5010; (2)
adopt the NCPDP Telecommunication Standard Implementation Guide,
Version D, Release 0 (Version D.0) and equivalent NCPDP Batch Standard
Implementation Guide, Version 1, Release 2 (Version 1.2); and (3)
retire NCPDP Telecommunication Standard Implementation Guide, Version
5, Release 1 (Version 5.1) and equivalent NCPDP Batch Standard
Implementation Guide, Version 1, Release 1 (Version 1.1), for
transmitting eligibility inquiries and responses between dispensers and
Part D sponsors with an effective date of January 1, 2012.
Contact: Andrew Morgan, 410-786-2543.
5. Physical and Occupational Therapist Qualifications (Sec. 440.110)
Current regulations detail provider qualifications for a `qualified
physical therapist' under Medicaid at 42 CFR 440.110(a)(2). Section
440.110(b)(2) details the provider qualifications for a `qualified
occupational therapist' under Medicaid. These current regulations
contain outdated terminology referencing several professional
organizations. Also some of the current qualification requirements do
not address individuals who have been trained outside of the United
States, or refer to outdated requirements, which could unintentionally
exclude otherwise qualified therapists resulting in diminished access
to care for Medicaid beneficiaries.
Medicare regulations at Sec. 484.4 were updated through a November
27, 2007 final rule (72 FR 66406), effective January 1, 2008. While
these personnel qualifications are detailed under home health services,
we indicated in the preamble to the November 27, 2007 final rule, that
therapy services must be provided according to the same standards and
policies in all settings, to the extent possible and consistent with
statute, and revised multiple regulations to cross-reference the
personnel qualifications for therapists in Sec. 484.4 to the personnel
requirements in many other sections.
We are proposing at Sec. 440.110 to remove the outdated personnel
qualifications language in the current Medicaid regulations and instead
cross reference the updated Medicare personnel qualifications for
physical therapists and occupational therapists under Sec. 484.4. This
proposal has the potential to broaden the scope of providers that may
be able to provide PT and OT services, by streamlining the
qualifications so that certain providers are not excluded from
providing services under Medicaid. In addition, it strengthens the
consistency of standards across Medicare and Medicaid.
Contact: Adrienne Delozier, 410-786-0278.
[[Page 65917]]
6. Definition of Donor Document (Sec. 486.302)
Section 486.302 includes the following definition: ``Donor document
is any documented indication of an individual's choice in regard to
donation that meets the requirements of the governing State law.'' In
recent years, the concept of the donor document and the opportunities
for individuals to express their wishes concerning organ and/or tissue
donation have changed. An individual can indicate his or her wishes not
only on a driver's license through a State's Department of Motor
Vehicles, but also on various registries or even in separate documents.
Therefore, we believe that our definition in Sec. 486.302 should be
updated. Moreover, the focus on patient rights has increased over the
last several years. For example, we published a final rule on November
19, 2010 entitled, ``Changes to the Hospital and Critical Access
Hospital Conditions of Participation to Ensure Visitation Rights for
All Patients'' (CMS-3228-F). In light of this increased focus, we
believe that the current definition, does not fully allow for the
various ways individuals can express their choices in the donor
process. In addition, we believe it is important to emphasize that the
decision to donate organs and/or tissue before death is the decision of
the individual.
We propose replacing the current definition of ``donor document''
in Sec. 486.302 with the following definition, ``[D]onor document
means any documented indication of an individual's choice that was
executed by the patient, in accordance with any applicable State law,
before his or her death, and that states his or her wishes regarding
organ and/or tissue donation.'' This new definition modifies the
current definition in two ways. First, while the current definition
refers to ``an individual's choice'' it does not recognize the right of
the individual to identify their wishes more specifically. Donor
documents may simply allow for the choice of whether or not to be an
organ and/or tissue donor, however, some individuals may choose to use
documents that allow them to express their wishes in more detail. For
example, some people may choose to be an organ donor, but not a tissue
donor. Others may not want to consent to the donation of specific
organs. Therefore, we believe our proposed definition should cover
documents or other ways for individuals to express their wishes more
specifically, and we have modified the definition accordingly.
Second, we also believe that it is important to include the
requirement that the donor document be ``executed by the patient.''
While this may appear self-evident, we want to emphasize that the
decision by a living person to donate organs and/or tissue after his or
her death is always a voluntary decision. Therefore, we have modified
the definition to account for this.
These changes to the definition of the donor document only affect
the documentation of an individual's wishes concerning organ and/or
tissue donation while they are alive and can legally make those
decisions. In the absence of a valid donor document, the donation
decisions would rest with the individual who is legally responsible for
making these decisions, usually the person's next of kin.
Contact: Jacqueline Morgan, 410-786-4282.
7. Administration and Governing Body (Sec. 486.324)
On May 31, 2006, we published a final rule in the Federal Register
(71 FR 30982) entitled, ``Conditions for Coverage for Organ Procurement
Organizations (OPOs).'' The final rule established several
requirements, for OPOs at Sec. 486.324, including a number of
requirements related to the administration and governing body of an
OPO. Due to an error in publishing the final rule, paragraph (e) was
inadvertently inserted twice (71 FR 31052).
We are proposing to remove the duplicate paragraph (e), which
appears immediately after Sec. 486.324(d). It does not alter or change
the legal requirement, nor does it create a change in information
collection requirements or other regulatory burden.
Contact: Jacqueline Morgan, 410-786-4282.
8. Requirement for Enrolling in the Medicare Program (Sec. 424.510)
We have identified an incorrect reference in Sec. 424.510(a), due
to a typographic error. We are proposing to replace the incorrect
reference to paragraph (c) (the effective date for reimbursement for
providers and suppliers seeking accreditation from a CMS-approved
accreditation organization) with a reference to paragraph (d) (the
enrollment requirements).
Contact: Morgan Burns, 202-690-5145
C. Responds to Stakeholder Concerns
The following proposals seek to respond to some of the concerns and
feedback that we have received from the public. In the comment period
associated with this proposed rule, we welcome additional suggestions
from stakeholders. We have identified nomenclature and definition
changes that would hopefully increase transparency and enhance our
relationship with the public.
Nomenclature Changes
1. Redefining the Term ``Beneficiary'' (Sec. 400.200 Through Sec.
400.203)
In response to comments from the public to discontinue our use of
the term ``recipient'' under Medicaid, we have been using the term
``beneficiary'' to mean all individuals who are entitled to, or
eligible for, Medicare or Medicaid services. We are proposing to add a
definition of ``beneficiary'' in Sec. 400.200 that applies to patients
under the Medicare and Medicaid programs. We would remove the terms
``beneficiary'' and ``recipient'' from Sec. 400.202 and Sec. 400.203,
respectively, and we would make a nomenclature change to replace
``recipient'' with ``beneficiary'' throughout 42 CFR chapter IV. The
action to refer to beneficiaries instead of recipients has already been
implemented. We are simply conforming our regulations to our current
use of the term ``beneficiary.'' In creating this definition it is not
our intent to exclude or include anyone who would or would not have
previously been understood to be a beneficiary. We welcome comments on
whether this definition could be improved to attain that objective.
Contact: Ronisha Davis, 410-786-6882.
2. Replace the Terms ``Mental Retardation'' and ``Mentally Retarded''
With ``Intellectual Disability'' and ``Intellectually Disabled''
Throughout 42 CFR title IV
We are proposing to change the terminology we use in the program
currently called Intermediate Care Facilities for the Mentally
Retarded. Section 1905(d) of the Act states that, ``The term
``intermediate care facility for the mentally retarded'' means an
institution (or distinct part thereof) for the mentally retarded or
persons with related conditions * * *.'' In 2010, Rosa's Law (Pub. L.
111-256) amended statutory language in several health and education
statues, directing that ``in amending the regulations to carry out this
Act, a Federal agency shall ensure that the regulations clearly state--
(A) That an intellectual disability was formerly termed ``mental
retardation''; and (B) that individuals with intellectual disabilities
were formerly
[[Page 65918]]
termed ``individuals who are mentally retarded.''
CMS regulations at 42 CFR chapter IV include numerous references to
``mental retardation.'' These regulatory provisions reflect the
statutory benefit category at section 1905(d) of the Act, which uses
the term ``mental retardation'' in the facility type designation,
``Intermediate Care Facility for the Mentally Retarded.'' Rosa's Law
did not specifically list the Act within its scope, and therefore did
not require any change to existing CMS regulations. However, consistent
with Rosa's Law and in response to numerous inquiries from provider and
advocate organizations as to when CMS will comply with the spirit of
Rosa's Law, we propose to adopt the term ``intellectual disability''
(as used under Rosa's Law) in our regulations at Sec. 400.203. We
would define the term ``intellectually disabled'' to mean the condition
that was previously referred to as ``mentally retarded'' in section
1919(e)(7)(G)(ii) of the Act. This nomenclature change does not
represent any change in information collection requirements or other
burden for the provider community or the State survey agencies. Current
forms may be used by the State survey agencies until current supplies
are exhausted. The change would require revision of forms CMS-3070G and
CMS-3070H, as discussed below.
Contact: Peggye Wilkerson, 410-786-4857.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, 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 Paperwork Reduction Act
of 1995 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 these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. Removes Unnecessarily Burdensome Requirements
1. ICRs Regarding End-Stage Renal Disease Facilities Condition for
Coverage: Physical Environment (Sec. 494.60)
In this rule, we are proposing to limit the number of ESRD
facilities that must meet the LSC requirements found in chapters 20 and
21 of NFPA 101. This proposal would reduce burden on ESRD facilities in
terms of costly structural modifications. However, this proposed change
does not impact any information collections under the Paperwork
Reduction Act.
2. ICRs Regarding Condition for Coverage: Emergency Equipment--
Ambulatory Surgical Centers (ASCs) (Sec. 416.44)
Proposed Sec. 416.44(c) would require ASCs to coordinate, develop,
and revise ASC policies and procedures that would specify the types of
emergency equipment required for use in the ASC's operating room. The
equipment must be immediately available for use during emergency
situations, be appropriate for the facility's patient population and be
maintained by appropriate personnel. The burden associated with these
requirements is the time and effort required by an ASC to develop
revised policies and procedures governing the identification and
maintenance of emergency equipment that would typically be required to
address the intra- or post-operative emergency complications specific
to the types of procedures performed in the ASC and the needs of their
specific patient population.
We believe that approximately 5,200 ASCs would have to comply with
these requirements. We estimate that proposed Sec. 416.44(c) would
impose a one-time burden of two hours associated with revising the
policies and procedures pertaining to the list of the emergency
equipment and supplies maintained and commonly used by the ASC during
emergency responses to their specific patient population. The total
burden associated with this task would be approximately 5,200 hours.
The total cost associated with this requirement would be $468,000
(5,200 x $90--based on an hourly nurse's salary ($45.00 x 2 hours),
including fringe benefits, as specified by the Bureau of Labor
Statistics for 2009).
Consistent with this proposed change, we will submit a revision to
control number 0938-1071 (expiration date October 31, 2012) to the
Office of Management and Budget for review.
3. ICRs Regarding Revocation of Enrollment and Billing Privileges in
the Medicare Program (Sec. 424.535)
In this rule, we are proposing to eliminate the re-enrollment bar
in instances when Medicare providers and suppliers have not responded
timely to requests for revalidation of enrollment or other requests for
information. This would allow providers and suppliers to attempt to re-
enroll in Medicare sooner than would be the case if the re-enrollment
bar applied. However, the overall information collection burden
involved--specifically, the need to submit a Form CMS-855 initial
enrollment application--would not change. Our proposed revision would
therefore neither increase nor decrease the existing information
collection burden related to this requirement.
4. ICRs Regarding Deactivation of Medicare Billing Privileges (Sec.
424.540)
In this rule, we are proposing to restrict the deactivation
provisions in Sec. 424.540(a)(1) to providers and suppliers that do
not complete the Form CMS-855I application. Physicians and non-
physician practitioners would therefore not have their Medicare billing
privileges deactivated if they did not bill Medicare for 12 consecutive
months.
We estimate that an average of approximately 12,000 physicians and
non-physician practitioners have been deactivated each year pursuant to
Sec. 424.540(a)(1). These individuals have been required to submit a
complete Form CMS-855I application to their Medicare contractor in
order to reactivate their Medicare billing privileges. With our
proposed change, however, this step would no longer be necessary
because the deactivation would not have occurred.
For purposes of this ICR, we estimate that 10,800 physicians and
non-physician practitioners (or 90 percent of the aforementioned 12,000
total) would continue to submit Form CMS-855I (OMB No. 0938-0685)
reactivation applications absent our proposed change. The estimated
``per application'' burden of completing the application is 5 hours, at
a per hour cost of $50. This results in a total savings in collection
of information costs for Medicare-enrolled physicians and non-physician
practitioners of approximately $2.7 million per year (10,800 x 5 x
$50). Consistent with this proposed change, we will submit a revision
to control number 0938-0685 to the Office of Management and Budget for
review.
[[Page 65919]]
5. ICRs Regarding Duration of Agreement for ICFs/ID (Sec. 442.15)
In this rule, we are proposing to remove the time limited
agreements for intermediate care facilities. There is no reduction in
burden or cost for the intermediate care facility providers but the
regulation change would help to reduce the paperwork and staff time
required by State agencies in processing temporary extensions of the
provider agreements that are required until the onsite survey occurs.
In addition, providers and State agencies would no longer face the
uncertainty created by the issuance of the multiple temporary
extensions due to the provider agreements. Consistent with this
proposed change, we will submit a revision to control number 0938-0062.
B. Removes Obsolete or Duplicative Regulations or Provides Clarifying
Information
1. ICRs Regarding Display of Currently Valid OMB Control Numbers (Sec.
400.310)
In this rule, we are proposing to remove the chart at Sec. 400.310
that display OMB control numbers because the information has become
obsolete. This proposal would not produce any reduction or increase in
burden, but would ensure that the public is viewing the most current
information regarding OMB control numbers.
2. ICRs Regarding Initial Determinations, Reconsiderations, Appeals,
and Reopenings Under Medicare Part A and B (Sec. 405.701 through Sec.
405.877)
The provisions in part 405 subparts G and H that we are proposing
to remove primarily are obsolete and no longer in use. We do not expect
an increase or reduction in burden, but believe that it would be
beneficial to ensure that providers or suppliers affected are using the
post BIPA appeals process.
3. ICRs Regarding Condition for Coverage: Infection Control--Ambulatory
Surgical Centers (ASCs) (Sec. 416.44)
In this rule, we are proposing to remove the requirement at Sec.
416.44(a)(3) regarding infection control that is duplicative of Sec.
416.51. The removal of this requirement would not result in any reduced
or additional burden on ASCs, but would alleviate any duplicative
efforts and confusion regarding the infection control requirements.
4. ICRs Regarding Standards for Electronic Prescribing (Sec. 423.160)
In this rule, we are proposing to update the current e-prescribing
standards to mirror the HIPAA standards that will be in effect as of
January 1, 2012. There is no burden (addition or reduction) associated
with this proposal.
5. ICRs Regarding Physical Therapy, Occupational Therapy, and Services
for Individuals With Speech, Hearing, and Language Disorders (Sec.
440.110)
In this rule, we are proposing to update and align provider
qualifications for PT and OT professionals. This proposal has the
potential to broaden the scope of providers that may be able to provide
PT and OT services, by streamlining the qualifications so that certain
providers are not excluded from providing services under Medicaid.
However, this proposed change does not impact any information
collections under the paperwork reduction Act.
6. ICRs Regarding Definitions (Sec. 486.302)
In this rule, we are proposing to modify the definition of ``donor
document'' to improve the ability of patients to indicate their wishes
regarding the donation of organs and tissue, while also emphasizing
that the patient's decision is voluntary. We do not expect that there
would be any changes in the collection of information requirements for
OPOs. We anticipate that the enhanced ability individuals initially
would have to more specifically identify their wishes would reduce
burden associated with vague and unclear designations.
7. ICRs Regarding Condition: Administration and Governing Body (Sec.
486.324)
In this rule, we are proposing the removal of the duplicate
paragraph (e) of Sec. 486.324. This proposal would not result in any
change in information collection or other regulatory burden.
8. ICRs Regarding Requirement for Enrolling in the Medicare Program
(Sec. 424.510)
In this rule, we are proposing to correct a typographical error
found in Sec. 424.510(a). This proposal would create no change in
information collection or other regulatory burden.
C. Responds to Stakeholder Concerns
Nomenclature Changes
1. ICRs Regarding General Definitions (Sec. 400.200)
In this rule, we are proposing to add a definition of
``beneficiary'' in Sec. 400.200 that applies to patients under the
Medicare and Medicaid programs. This proposal would create no change in
information collection or other regulatory burden.
2. ICRs Regarding Definitions Specific to Medicaid (Sec. 400.203)
In this rule, we are proposing to add to the regulations a
definition of ``intellectual disability'' for purposes of the Medicaid
program that would define it, consistent with Rosa's law (Pub. L. 111-
256), as the condition formerly referred to as ``mental retardation''
and we would replace all references in CMS regulations to ``mental
retardation'' with ``intellectual disability.'' Furthermore, we propose
to replace the term ``mentally retarded,'' as defined in section
1919(e)(7)(G)(ii) of the Act, with ``intellectually disabled.'' This
proposal would create no change in information collection or other
regulatory burden. The change would require revision of forms CMS-3070G
and CMS-3070H, which are approved under OMB control number 0938-0062
(expiration date April 30, 2013). CMS will submit this collection to
OMB for review.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget,
Attention: CMS Desk Officer, [CMS-9070-P];
Fax: (202) 395-5806; or
E-mail: [email protected].
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
We have examined the impact 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
(February 2, 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
[[Page 65920]]
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
and Executive Order 13132 on Federalism (August 4, 1999).
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). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
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 proposed rule would reduce costs to
regulated entities and to patients by more than $100 million, perhaps
as much as $200 million in the first year. It would also create
significant life savings benefits. It is therefore an economically
significant rule under section 3(f)(1) of Executive Order 12866.
Accordingly, this proposed rule was reviewed by the Office of
Management and Budget.
A. Statement of Need
In Executive Order 13563, the President recognized the importance
of a streamlined, effective, efficient regulatory framework designed to
promote economic growth, innovation, job creation, and competitiveness.
To achieve a more robust and effective regulatory framework, the
President has directed each executive agency to establish a plan for
ongoing retrospective review of existing significant regulations to
identify those rules that can be eliminated as obsolete, unnecessary,
burdensome, or counterproductive or that can be modified to be more
effective, efficient, flexible, and streamlined. This proposal responds
directly to the President's instructions in Executive Order 13563 by
reducing outmoded or unnecessarily burdensome rules, and thereby
increasing the ability of health care entities to devote resources to
providing high quality patient care.
B. Overall Impact
There are cost savings in many areas. Two areas of one-time savings
are particularly substantial. First, as indicated earlier in the
preamble, we estimate that one-time savings to ESRD facilities are
likely to range from about $47.5 to $217 million. Second, we also
estimate a one-time savings of $18.5 million to ASCs through reduced
emergency equipment requirements. Both of these estimates are uncertain
and total savings could be significantly higher. Among the many types
of recurring savings that these proposals would create, physicians and
other providers would avoid business and payment losses that are
difficult to estimate but likely to be in the tens of millions of
dollars annually through the reforms we propose for reenrollment and
billing processes. We have identified other kinds of savings that
providers and patients will realize throughout this preamble. All of
these are summarized in the table that follows.
Table 3--Section-by-Section Economic Impact Estimates
------------------------------------------------------------------------
Likely savings or
Section Frequency benefits ($
millions)
------------------------------------------------------------------------
A. Removes Unnecessarily
Burdensome Requirements:
1. End-Stage Renal Disease One-Time.......... 108.7
(ESRD) Facilities (Sec.
494.60).
2. ASC Emergency Equipment One-Time.......... 18.5
(Sec. 416.44).
3. Revocation of Enrollment/ Recurring......... 10.0
Billing Privileges (Sec.
424.535).
4. Deactivation of Medicare Recurring......... 26.7
Billing Privileges (Sec.
424.540).
5. Duration of Agreement for Recurring......... <1
ICFs/ID (Sec. 442.15-Sec.
442.109).
B. Removes Obsolete or
Duplicative Regulations:
1. OMB Control Numbers for Recurring......... <1
Information Collection (Sec.
400.300 and Sec.
400.310).
2. Removal of Obsolete Recurring......... <1
Provisions Related to
Processing Part A and Part B
Claims and Entitlement
Determinations (Sec.
405.701 through Sec.
405.877).
3. ASC Infection Control Recurring......... <1
Program (Sec. 416.44).
4. E-prescribing (Sec. Recurring......... <1
423.160).
5. Physical and Occupational Recurring......... <1
Therapist Qualifications
(Sec. 440.110).
6. Definition of Donor Recurring......... (\1\)
Document (Sec. 486.302).
7. Administration and Recurring......... <1
Governing Body (Sec.
486.324).
8. Requirement for Enrolling Recurring......... <1
in the Medicare Program
(Sec. 424.510).
C. Responds to Stakeholder
Concerns:
Nomenclature Changes
1. Redefining the Term Recurring......... <1
``Beneficiary'' (Sec.
400.200 through Sec.
400.203).
2. Replace ``Mental Recurring......... (\1\)
Retardation'' terminology
with ``Intellectual
Disability'' (throughout 42
CFR title IV).
------------------------------------------------------------------------
\1\ See Text.
There are two areas of potentially significant benefits, above and
beyond cost savings to providers. First, improved organ donation
consent language that would enable prospective donors to specify their
intentions more clearly would have a positive effect on organ donation.
There are approximately 8,000 cadaveric organ donors annually in the
United States. These donors provide a total of about 21,000
transplanted organs (see the OPTN/SRTR Annual Report at http://optn.transplant.hrsa.gov/ar2009/). The decision to make a firm, written
decision on whether or not to be a potential donor, and on the
willingness of families to honor that decision, can turn on very small
issues of personal preference. We believe that the change we propose
could and likely would tip that decision in some cases. However, we do
not have a basis for quantifying this potential increase in donations.
We welcome comment on the extent to which this policy change may
increase organ donation and any information that would assist in
quantifying these impacts.
[[Page 65921]]
In addition, while Rosa's Law began the elimination of official
Federal government use of the pejorative term ``mental retardation,''
our proposal would complete this step for CMS regulations. The reform
undoubtedly has substantial value to millions of Americans, not only to
the intellectually disabled but also to their families and friends, and
also to the many millions who simply object to such labeling. However,
we have no data that would enable a precise calculation of this value.
Taking all of the proposed reforms together, we estimate that the
overall cost savings that this rule would create may approach $200
million in the first year. This includes the one-time savings related
to ESRD reforms, as well as the savings to providers in lost billings,
paperwork costs, confusion, and other burden reductions discussed
throughout this preamble.
C. Anticipated Impacts
The potential cost savings from reduced ESRD requirements are
discussed extensively in that preamble section on those reforms.
Assuming that the average cost for a facility to meet three structural
standards would have been $77,659, and that one half of all facilities
would have needed to make one half of these investments, total savings
would be $108.7 million (2,800 x ($77,659/2)).
The only other large one-time savings estimates are those resulting
from reforms of Ambulatory Surgical Center Emergency equipment
requirements, and reforms in the revocations or deactivation of billing
privileges. As to ASC, we estimate that the three most costly types of
equipment are as follows: Tracheostomy kit $100.00, cricothyrotomy kit
$200.00 and mechanical ventilator $12,000. We utilized fiscal year 2010
surveyor worksheets completed by the States when conducting ASC surveys
to project the distribution of the types of ASC services nationally. We
estimate that about two-thirds of the approximately Medicare 5,200
certified ASCs are functioning as multipurpose facilities. Those that
are not multipurpose facilities would not have to spend $12,300 in
total for costly equipment that would not be utilized. We have
estimated the savings by breaking down each specialty type of ASC that
would not be considered a multipurpose facility and that may not
eliminate all three pieces of equipment or choose just one or two
depending on the needs of the facility (1,500 ASCs x $12,300 = total
savings of about $18.5 million).
With respect to the revocation reform, the number of affected
providers is certainly very small as a proportion of the total universe
of over one million Medicare providers, of whom over 900,000 are
physicians and other practitioners. Based on administrative data, we
estimate that the number of affected physicians and other practitioners
that would be affected by this reform is between 1,000 and 2,000, a
fraction of one percent of these. We have no statistical data on the
resultant economic effects; but if the average provider loses as little
as $10,000 in billable Medicare patient care services as a result of
deactivation, total lost business for 1,000 providers could be $10
million annually. In this regard, gross annual physician practice
revenue in America approaches $1 million a year (see, for example, the
practice expense data in http://www.modernmedicine.com/modernmedicine/article/articleDetail.jsp?id=143141). Since Medicare pays about one
third of revenue received for professional services such as physician
care, the loss we estimate is one or two weeks of Medicare billing, on
average. We welcome additional information on the likely magnitude and
frequency of such losses.
With respect to deactivation of Medicare billing privileges, based
on existing enrollment data we believe that about 12,000 physicians and
non-physician practitioners may be affected annually. While the
information collection consequences are relatively small (see the
Information Collection section of this preamble), the problems this
creates for both providers and patients are more substantial, including
confusion about which bills are paid, chains of correspondence between
the provider, the patient, and the Medicare contractor, and even in
many cases an inability of providers to obtain reimbursement for
services provided. Furthermore, although the direct paperwork costs are
small, the amount of time and effort involved may deter some of these
providers from even attempting to reactivate their billing privileges.
Nonetheless, even if the average lost billing amounts (over and above
amounts previously calculated for deactivations) are only on average
$2,000, total annual costs in patient services that were unbilled or
simply not provided would be $24 million (12,000 providers x $2,000),
in addition to the $2.7 million we estimate in reduced information
collection costs. In this regard, we point out that $2,000 represents
only a fraction of one percent of average annual physician billing to
Medicare, or less than one week of billing lost. We believe that losses
are likely to be this low because this problem is most likely to occur
with providers whose practices include relatively few Medicare
patients, or who otherwise do not depend heavily on Medicare
reimbursements (for example, part-time practices and those nearing
retirement). We welcome additional information on the likely magnitude
and frequency of such losses, and on physician and other provider
situations most likely to be affected by such losses.
Of the remaining reforms, most have minor cost savings as shown in
Table 1 through entries of $1 million or less. We welcome comments on
whether some of these proposed reforms may create larger savings that
we have failed to identify.
D. 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 cost
savings, we are uncertain about the magnitude of these effects. In
addition, as we previously explained, there may be significant
additional health benefits. Thus, we are confident that the rule would
yield net benefits. In this analysis we provided some illustrative
estimates to suggest the potential savings these reforms could achieve
under certain assumptions. We welcome comments on ways to better
estimate the likely effects of these reforms.
E. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), we have prepared an
accounting statement. We estimate that the overall cost savings that
this rule would create may approach $200 million in the first year.
This includes the one-time savings related to ESRD reforms, as well as
the savings to providers in lost billings, paperwork costs, confusion,
and other burden reductions discussed throughout this preamble. There
are also potentially substantial life-saving benefits that could reach
hundreds of millions of dollars annually. Annualized savings are shown
in the accounting statement below.
[[Page 65922]]
Table 4--Accounting Statement
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
Discount rate Period
Category Primary estimate Year dollars (%) covered
----------------------------------------------------------------------------------------------------------------
Benefits:
Unquantified Qualitative Value of Potentially hundreds of 2012 7 2012-16
Lives Saved Through Increases in lives saved but no
Organ Donations. precise estimate.
Potentially hundreds of 2012 3 2012-16
lives saved but no
precise estimate.
Annualized savings from reduced $30..................... 2012 7 2012-16
ESRD facility investments and
reduced ASC costs (see Table 3).
$30..................... 2012 3 2012-16
Annualized savings to providers $40..................... 2012 7 2012-16
from billing improvements and
other reforms (see Table 3).
$40..................... 2012 3 2012-16
Costs:
None.
Transfers:
None.
----------------------------------------------------------------------------------------------------------------
F. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) requires agencies to analyze
options for regulatory relief of small entities when proposed rules
create a significant economic impact on a substantial number of small
entities. For purposes of the RFA, small entities include small
businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other Medicare or Medicaid
providers and suppliers are small entities, either by nonprofit status
or by having revenues of $7.0 million to $34.5 million in any 1 year.
Individuals and States are not included in the definition of a ``small
entity.'' This proposed rule would reduce costs to tens of thousands of
physicians, ASCs, ESRD facilities, and other small entities. Provisions
in this proposed rule would benefit some providers or suppliers in all
or virtually all of the industries identified as ``Ambulatory Health
Care Services'' under the Census Bureau's North American Industry
Classification System (NAICS, codes 621111 through 621999). While most
of the effects would be minimal (for example, eliminating obsolete and
redundant or confusing regulatory requirements), we estimate that the
impact on at least several thousand of these small entities would be
economically significant. The purpose of the RFA is to reduce burdens
on regulated entities, and HHS interprets the RFA as requiring an
Initial Regulatory Flexibility Analysis (IRFA) only when a proposed
rule creates an adverse economic impact. Accordingly, we certify that
this proposed rule would not have a significant economic impact on a
substantial number of small entities. HHS nonetheless voluntarily
prepares an IRFA for rules that, like this one, create a significant
positive economic impact by reducing burden on small entities. In this
case all of the economic effects of the proposed rule are positive, and
some are economically significant. In particular, provisions that allow
physicians and other providers and suppliers to continue to participate
in Medicare despite correspondence mishaps would save as many as 12,000
small entity providers annually thousands, and in some cases tens of
thousands, of dollars in lost revenues, as well as reduce costs of
confusion and correspondence to both these providers and their
patients. Most of these providers are physicians, but other affected
professionals include clinical psychologists, physician assistants,
nurse practitioners, and physical therapists. Substantial savings would
also accrue to most of about 6,500 ESRD providers from our proposal to
eliminate fire safety requirements that are vital in residential
provider settings, but unnecessary in ambulatory care facilities such
as these. Approximately half of the 5,200 ASCs would benefit from more
sensible emergency equipment policies. In addition, while we cannot
estimate the number of positively affected entities for every provision
we propose, these reforms would benefit about 6,400 Intermediate Care
Facilities through elimination of pejorative nomenclature that
pervasively affects their names and operations. All of the provisions
included in the proposed rule aim to identify and eliminate
duplicative, overlapping, outdated and conflicting regulatory
requirements that unnecessarily add confusion or costs to various
providers or patients as they attempt to navigate excessive or obsolete
or contradictory regulatory requirements. By making these changes, we
believe health professionals would have increased resources to devote
to improving patient care, increasing accessibility to care and
reducing associated health care costs. We invite and welcome comments
on any and all of the provisions of the proposed rule with regard to
the impacts of the burden reductions, as well as alternatives, if any,
we should consider in the final rule or in future rulemaking on other
regulatory provisions.
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. This rule
has no direct effects on hospitals. Therefore, we are not preparing an
analysis for section 1102(b) of the Act because we have determined, and
the Secretary certifies, that this proposed rule would not have a
significant impact on the operations of a substantial number of small
rural hospitals.
G. Unfunded Mandates Reform Act
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 expenditures in any 1 year of
$100 million in 1995 dollars, updated
[[Page 65923]]
annually for inflation on either State, local, or tribal governments,
or the private sector. In 2011, that threshold is approximately $136
million. This proposed rule mandates no new expenditures by either
State, local, or tribal governments, or the private sector.
H. Federalism
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. Since this regulation does not impose any costs on State
or local governments, the requirements of Executive Order 13132 are not
applicable.
List of Subjects
42 CFR Part 400
Grant programs--health, Health facilities, Health maintenance
organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 416
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Emergency medical services,
Health facilities, Health Maintenance Organizations (HMO), Health
professionals, Medicare, Penalties, Privacy, Reporting and
recordkeeping requirements.
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 440
Grant programs--health, Medicaid.
42 CFR Part 442
Grant programs--health, Health facilities, Health professions,
Medicaid, Nursing homes, Reporting and recordkeeping requirements.
42 CFR Part 486
Grant programs--health, Health facilities, Medicare, Reporting and
recordkeeping requirements, X-rays.
42 CFR Part 494
Health facilities, Kidney 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 400--INTRODUCTION; DEFINITIONS
1. The authority citation for part 400 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.
Subpart B--Definitions
2. Section 400.200 is amended by adding the definition of
``beneficiary'' in alphabetical order to read as follows:
Sec. 400.200 General definitions.
* * * * *
Beneficiary means a person who is entitled to Medicare benefits
and/or has been determined to be eligible for Medicaid.
* * * * *
Sec. 400.202 [Amended]
3. Section 400.202 is amended by removing the definition of
``beneficiary.''
4. Section 400.203 is amended by removing the definition of
``recipient'' and adding the definition of ``intellectual disability''
in alphabetical order to read as follows:
Sec. 400.203 Definitions specific to Medicaid.
* * * * *
Intellectual disability means the condition that was previously
referred to as mental retardation.
* * * * *
Subpart C--[Removed and Reserved]
5. Subpart C, consisting of Sec. Sec. 400.300 and 400.310, is
removed and reserved.
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
6. The authority citation for part 405 continues to read as
follows:
Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874,
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).
7. Redesignate Sec. 405.706 in subpart G as Sec. 405.925 in
subpart I.
Subpart G--[Removed and Reserved]
8. Remove and reserve subpart G consisting of Sec. 405.701 through
Sec. 405.705 and Sec. 405.708 through Sec. 405.753.
9. Subpart H is revised to read as follows:
Subpart H--Appeals Under the Medicare Part B Program
Sec.
405.800 Appeals of CMS or a CMS contractor.
405.803 Appeals rights.
405.806 Impact of reversal of contractor determinations on claims
processing.
405.809 Reinstatement of provider or supplier billing privileges
following corrective action.
405.812 Effective date for DMEPOS supplier's billing privileges.
405.815 Submission of claims.
405.818 Deadline for processing provider enrollment initial
determinations.
Authority: Secs. 1102, 1866(j), and 1871 of the Social Security
Act (42 U.S.C. 1302, 1395cc(j), and 1395hh).
Subpart H--Appeals Under the Medicare Part B Program
Sec. 405.800 Appeals of CMS or a CMS contractor.
A CMS contractor's (that is, a carrier, Fiscal Intermediary or
Medicare Administrative Contractor (MAC)) determination that a provider
or supplier fails to meet the requirements for Medicare billing
privileges.
(a) Denial of a provider or supplier enrollment application. If CMS
or a CMS contractor denies a provider's or supplier's enrollment
application, CMS or the CMS contractor notifies the provider or
supplier by certified mail. The notice includes the following:
(1) The reason for the denial in sufficient detail to allow the
provider or supplier to understand the nature of its deficiencies.
(2) The right to appeal in accordance with part 498 of this
chapter.
(3) The address to which the written appeal must be mailed.
(b) Revocation of Medicare billing privileges--(1) Notice of
revocation. If CMS or a CMS contractor revokes a provider's or
supplier's Medicare billing privileges, CMS or a CMS contractor
notifies the supplier by certified mail. The notice must include the
following:
(i) The reason for the revocation in sufficient detail for the
provider or supplier to understand the nature of its deficiencies.
(ii) The right to appeal in accordance with part 498 of this
chapter.
[[Page 65924]]
(iii) The address to which the written appeal must be mailed.
(2) Effective date of revocation. The revocation of a provider's or
supplier's billing privileges is effective 30 days after CMS or the CMS
contractor mails notice of its determination to the provider or
supplier, except if the revocation is based on a Federal exclusion or
debarment, felony conviction, license suspension or revocation, or the
practice location is determined by CMS or its contractor not to be
operational. When a revocation is based on a Federal exclusion or
debarment, felony conviction, license suspension or revocation, or the
practice location is determined by CMS or its contractor not to be
operational, the revocation is effective with the date of exclusion or
debarment, felony conviction, license suspension or revocation or the
date that CMS or its contractor determined that the provider or
supplier was no longer operational.
(3) Payment after revocation. Medicare does not pay, and the CMS
contractor rejects, claims for services submitted with a service date
on or after the effective date of a provider's or supplier's
revocation.
Sec. 405.803 Appeals rights.
(a) A provider or supplier may appeal the initial determination to
deny a provider or supplier's enrollment application, or if applicable,
to revoke current billing privileges by following the procedures
specified in part 498 of this chapter.
(b) The reconsideration of a determination to deny or revoke a
provider or supplier's Medicare billing privileges is handled by a CMS
Regional Office or a contractor hearing officer not involved in the
initial determination.
(c) Providers and suppliers have the opportunity to submit evidence
related to the enrollment action. Providers and suppliers must, at the
time of their request, submit all evidence that they want to be
considered.
(d) If supporting evidence is not submitted with the appeal
request, the contractor contacts the provider or supplier to try to
obtain the evidence.
(e) If the provider or supplier fails to submit the evidence before
the contractor issues its decision, the provider or supplier is
precluded from introducing new evidence at higher levels of the appeals
process.
Sec. 405.806 Impact of reversal of contractor determinations on
claims processing.
(a) Claims for services furnished to Medicare beneficiaries during
a period in which the supplier billing privileges were not effective
are rejected.
(b) If a supplier is determined not to have qualified for billing
privileges in one period but qualified in another, Medicare contractors
process claims for services furnished to beneficiaries during the
period for which the supplier was Medicare-qualified. Subpart C of this
part sets forth the requirements for the recovery of overpayments.
(c) If a revocation of a supplier's billing privileges is reversed
upon appeal, the supplier's billing privileges are reinstated back to
the date that the revocation became effective.
(d) If the denial of a supplier's billing privileges is reversed
upon appeal and becomes binding, then the appeal decision establishes
the date that the supplier's billing privileges become effective.
Sec. 405.809 Reinstatement of provider or supplier billing privileges
following corrective action.
If a provider or supplier completes a corrective action plan and
provides sufficient evidence to the CMS contractor that it has complied
fully with the Medicare requirements, the CMS contractor may reinstate
the provider's or supplier's billing privileges. The CMS contractor may
pay for services furnished on or after the effective date of the
reinstatement. The effective date is based on the date the provider or
supplier is in compliance with all Medicare requirements. A CMS
contractor's refusal to reinstate a supplier's billing privileges based
on a corrective action plan is not an initial determination under part
498 of this chapter.
Sec. 405.812 Effective date for DMEPOS supplier's billing privileges.
If a CMS contractor, contractor hearing officer, or ALJ determines
that a DMEPOS supplier's denied enrollment application meets the
standards in Sec. 424.57 of this chapter and any other requirements
that may apply, the determination establishes the effective date of the
billing privileges as not earlier than the date the carrier made the
determination to deny the DMEPOS supplier's enrollment application.
Claims are rejected for services furnished before that effective date.
Sec. 405.815 Submission of claims.
A provider or supplier succeeding in having its enrollment
application denial or billing privileges revocation reversed in a
binding decision, or in having its billing privileges reinstated, may
submit claims to the CMS contractor for services furnished during
periods of Medicare qualification, subject to the limitations in Sec.
424.44 of this chapter, regarding the timely filing of claims. If the
claims previously were filed timely but were rejected, they are
considered filed timely upon resubmission. Previously denied claims for
items or services furnished during a period of denial or revocation may
be resubmitted to CMS within 1 year after the date of reinstatement or
reversal.
Sec. 405.818 Deadline for processing provider enrollment initial
determinations.
Contractors approve or deny complete provider or supplier
enrollment applications to approval or denial within the following
timeframes:
(a) Initial enrollments--Contractors process new enrollment
applications within 180 days of receipt.
(b) Revalidation of existing enrollments--Contractors process
revalidations within 180 days of receipt.
(c) Change-of-information and reassignment of payment request--
Contractors process change-of-information and reassignment of payment
requests within 90 days of receipt.
PART 416--AMBULATORY SURGICAL SERVICES
10. The authority citation for part 416 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Specific Conditions for Coverage
11. Section 416.44 is amended by--
a. Removing paragraph (a)(3).
b. Revising paragraph (c).
The revisions read as follows:
Sec. 416.44 Condition for coverage--Environment.
* * * * *
(c) Standard: Emergency equipment. The ASC medical staff and
governing body of the ASC coordinates, develops, and revises ASC
policies and procedures to specify the types of emergency equipment
required for use in the ASC's operating room. The equipment must meet
the following requirements:
(1) Be immediately available for use during emergency situations.
(2) Be appropriate for the facility's patient population.
(3) Be maintained by appropriate personnel.
* * * * *
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
12. The authority citation for part 423 continues to read as
follows:
[[Page 65925]]
Authority: Section 1860D-4(e) of the Social Security Act (42
U.S.C 1395w-104(e)).
Subpart D--Cost Control and Quality Improvement Requirements
13. Section 423.160 is amended by revising paragraph (b)(3) to read
as follows:
Sec. 423.160 Standards for electronic prescribing.
* * * * *
(b) * * *
(3) Eligibility. (i) The Accredited Standards Committee X12N 270/
271-Health Care Eligibility Benefit Inquiry and Response, Version 5010,
April 2008, ASC X12N/005010x279 (incorporated by reference in paragraph
(c)(2)(i) of this section), for transmitting eligibility inquiries and
responses between prescribers and Part D sponsors.
(ii) The National Council for Prescription Drug Programs
Telecommunication Standard Specification, Version D, Release 0 (Version
D.0), August 2007, and equivalent NCPDP Batch Standard Batch
Implementation Guide, Version 1, Release 2 (Version 1.2), January 2006
supporting Telecommunications Standard Implementation Guide, Version D,
Release 0 (Version D.0), August 2007, for the NCPDP Data Record in the
Detail Data Record (incorporated by reference in paragraph (c)(1)(iii)
of this section), for transmitting eligibility inquiries and responses
between dispensers and Part D sponsors.
* * * * *
PART 424--CONDITIONS FOR MEDICARE PAYMENT
14. The authority citation for part 424 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart P--Requirements for Establishing and Maintaining Medicare
Billing Privileges
15. Section 424.510 is amended by revising paragraph (a) to read as
follows:
Sec. 424.510 Requirements for enrolling in the Medicare program.
(a) Providers and suppliers must submit enrollment information on
the applicable enrollment application. Once the provider or supplier
successfully completes the enrollment process, including, if
applicable, a State survey and certification or accreditation process,
CMS enrolls the provider or supplier into the Medicare program. To be
enrolled, a provider or supplier must meet enrollment requirements
specified in paragraph (d) of this section.
* * * * *
16. Section 424.535 is amended by revising paragraph (c) to read as
follows:
Sec. 424.535 Revocation of enrollment and billing privileges in the
Medicare program.
* * * * *
(c) Reapplying after revocation. After a provider, supplier,
delegated official, or authorizing official has had their billing
privileges revoked, they are barred from participating in the Medicare
program from the effective date of the revocation until the end of the
re-enrollment bar. The re-enrollment bar is a minimum of 1 year, but
not greater than 3 years, depending on the severity of the basis for
revocation. The re-enrollment bar does not apply in the event a
revocation of Medicare billing privileges is imposed under paragraph
(a)(1) of this section based upon a provider or supplier's failure to
respond timely to a revalidation request or other request for
information.
* * * * *
17. Section 424.540(a) is revised to read as follows:
Sec. 424.540 Deactivation of Medicare billing privileges.
(a) Reasons for deactivation. CMS may deactivate the Medicare
billing privileges of a provider or supplier for any of the following
reasons:
(1) The provider or supplier does not submit any Medicare claims
for 12 consecutive calendar months. This requirement does not apply to
suppliers that enroll in the Medicare program using a Form CMS-855I.
The 12-month period will begin the 1st day of the 1st month without a
claims submission through the last day of the 12th month without a
submitted claim.
(2) The provider or supplier does not report a change to the
information supplied on the enrollment application within 90 calendar
days of when the change occurred. Changes that must be reported
include, but are not limited to, a change in practice location, a
change of any managing employee, and a change in billing services. A
change in ownership or control must be reported within 30 calendar days
as specified in Sec. 424.520(b) and Sec. 424.550(b).
(3) The provider or supplier does not furnish complete and accurate
information and all supporting documentation within 90 calendar days of
receipt of notification from CMS to submit an enrollment application
and supporting documentation, or resubmit and certify to the accuracy
of its enrollment information.
* * * * *
PART 440--SERVICES: GENERAL PROVISIONS
18. The authority citation for part 440 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
302).
Subpart A--Definitions
19. Section 440.110 is amended by revising paragraphs (a)(2) and
(b)(2) to read as follows:
Sec. 440.110 Physical therapy, occupational therapy, and services for
individuals with speech, hearing, and language disorders.
(a) * * *
(2) A ``qualified physical therapist'' is an individual who meets
personnel qualifications for a physical therapist at Sec. 484.4.
(b) * * *
(2) A ``qualified occupational therapist'' is an individual who
meets personnel qualifications for an occupational therapist at Sec.
484.4.
* * * * *
PART 442--STANDARDS FOR PAYMENT TO NURSING FACILITIES AND
INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED
20. The authority citation for part 442 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302), unless otherwise noted.
Subpart B--Provider Agreements
21. Section 442.15 is revised to read as follows:
Sec. 442.15 Duration of agreement for ICFs/ID.
(a) The agreement for an ICF/MR remains in effect until the
Secretary determines that the facility no longer meets the applicable
requirements. The State Survey Agency must conduct a survey of the
facility to determine compliance with the requirements at a survey
interval of no greater than 15 months.
(b) FFP is available for services furnished by a facility for up to
30 days after its agreement expires or terminates under the conditions
specified in Sec. 441.11 of this subchapter.
Sec. 442.16 [Removed and Reserved]
22. Section 442.16 is removed and reserved.
[[Page 65926]]
Subpart C--Certification of ICFs/ID
23. Section 442.109 is revised to read as follows:
Sec. 442.109 Certification period for ICFs/ID: General provisions.
(a) A survey agency may certify a facility that fully meets
applicable requirements. The State Survey Agency must conduct a survey
of each ICF/MR not later than 15 months after the last day of the
previous survey.
(b) The statewide average interval between surveys must be 12
months or less, computed in accordance with paragraph (c) of this
section.
(c) The statewide average interval is computed at the end of each
Federal fiscal year by comparing the last day of the most recent survey
for each participating facility to the last day of each facility's
previous survey.
24. Section 442.110 is amended by revising paragraph (b) to read as
follows:
Sec. 442.110 Certification period for ICFs/ID with standard-level
deficiencies.
* * * * *
(b) The survey agency may certify a facility for a period that ends
no later than 60 days after the last day specified in the plan for
correcting deficiencies. The certification period must not exceed 15
months, including the period allowed for corrections.
* * * * *
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
25. 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).
Subpart G--Requirements for Certification and Designation and
Conditions for Coverage: Organ Procurement Organizations
26. Section 486.302 is amended by revising the definition of
``donor document'' to read as follows:
Sec. 486.302 Definitions.
* * * * *
Donor document means any documented indication of an individual's
choice that was executed by the patient, in accordance with any
applicable State law, prior to his or her death, and that states his or
her wishes regarding organ and/or tissue donation.
* * * * *
Sec. 486.324 [Amended]
27. Section 486.324 is amended by removing the second paragraph
(e).
PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
FACILITIES
28. 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. 1302 and 1395hh).
Subpart B--Patient Safety
29. Section 494.60(e) is revised to read as follows:
Sec. 494.60 Condition: Physical environment.
* * * * *
(e) Standard: Fire safety. (1) Except as provided in paragraph
(e)(2) of this section, by February 9, 2009, dialysis facilities that
are located adjacent to high hazardous occupancies or do not provide
one or more exits to the outside at grade level from the patient
treatment area level, must comply with applicable provisions of the
2000 edition of the Life Safety Code of the National Fire Protection
Association (which is incorporated by reference at Sec.
403.744(a)(1)(i) of this chapter).
(2) Notwithstanding paragraph (e)(1) of this section, dialysis
facilities participating in Medicare as of October 14, 2008 that
require sprinkler systems are those housed in multi-story buildings of
construction Types II(000), III(200), or V(000), as defined in the 2000
edition of the Life Safety Code of the National Fire Protection
Association (which is incorporated by reference at Sec.
403.744(a)(1)(i) of this chapter), section 21.1.6.3, which were
constructed after January 1, 2008; and those housed in high rise
buildings over 75 feet in height.
* * * * *
Nomenclature Changes
30. In 42 CFR chapter IV, remove ``Recipient'' and ``Recipients''
wherever they appear and add in their place ``Beneficiary'' and
``Beneficiaries,'' respectively.
31. In 42 CFR chapter IV, remove ``Mental Retardation,'' ``Mentally
Retarded'' and the abbreviated form ``MR'' wherever they appear and add
in their place ``Intellectual Disability,'' ``Intellectually Disabled''
and ``ID,'' respectively.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: July 28, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: October 6, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-27176 Filed 10-18-11; 11:15 am]
BILLING CODE 4120-01-P