[Federal Register Volume 78, Number 144 (Friday, July 26, 2013)]
[Notices]
[Pages 45205-45208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10326, CMS-10487, CMS-P-0015A, CMS-R-10,
CMS-R-240, CMS-10282, CMS-R-65 and CMS-10491]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by September 24, 2013:
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development,Attention: Document Identifier/OMB
Control Number --------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10326 Electronic Submission of Medicare Graduate Medical
Education (GME) Affiliation Agreements
CMS-10487 Medicaid Emergency Psychiatric Demonstration (MEPD)
Evaluation
CMS-P-0015A Medicare Current Beneficiary Survey
CMS-R-10 Advance Directives (Medicare and Medicaid) and Supporting
Regulations
[[Page 45206]]
CMS-R-240 Prospective Payments for Hospital Outpatient Services and
Supporting Regulations
CMS-10282 Conditions of Participation for Comprehensive Outpatient
Rehabilitation Facilities (CORFs) and supporting regulations
CMS-R-65 Final Peer Review Organizations Sanction Regulations in 42
CFR Sections 1004.40, 1004.50, 1004.60, and 1004.70
CMS-10491 Enrollment Assistance Program
Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520),
federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. The term ``collection of information'' is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA requires federal agencies to publish a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice.
Information Collections
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Electronic
Submission of Medicare Graduate Medical Education (GME) Affiliation
Agreements; Use: We use the information contained in electronic
affiliation agreements as documentation of the existence of Medicare
GME affiliations, and to verify that the affiliations being formed by
teaching hospitals for the purposes of sharing their Medicare Graduate
Medical Education FTE cap slots are valid according to CMS regulations.
The affiliation agreements are also used as reference materials when
potential issues involving specific affiliations arise. Form Number:
CMS-10326 (OCN: 0938-1111); Frequency: Yearly; Affected Public: Private
sector--Business or other for-profits and Not-for-profit institutions;
Number of Respondents: 125; Total Annual Responses: 125; Total Annual
Hours: 166. (For policy questions regarding this collection contact
Tzvi Hefter at 410-786-0614.)
2. Type of Information Collection Request: New Collection (Request
for a new OMBcontrol number); Title of Information Collection: Medicaid
Emergency Psychiatric Demonstration (MEPD) Evaluation; Use: Since the
inception of Medicaid, inpatient care provided to adults ages 21 to 64
in institutions for mental disease (IMDs) has been excluded from
federal matching funds. The Emergency Medical Treatment and Active
Labor Act (EMTALA), however, requires IMDs that participate in Medicare
to provide treatment for psychiatric emergency medical conditions
(EMCs), even for Medicaid patients for whose services cannot be
reimbursed. Section 2707 of the Affordable Care Act (ACA) directs the
Secretary of Health and Human Services to conduct and evaluate a
demonstration project to determine the impact of providing payment
under Medicaid for inpatient services provided by private IMDs to
individuals with emergency psychiatric conditions between the ages of
21 and 64. We will use the data to evaluate the Medicaid Emergency
Psychiatric Demonstration (MEPD) in accordance with the ACA mandates.
This evaluation in turn will be used by Congress to determine whether
to continue or expand the demonstration. If the decision is made to
expand the demonstration, the data collected will help to inform both
CMS and its stakeholders about possible effects of contextual factors
and important procedural issues to consider in the expansion, as well
as the likelihood of various outcomes. Form Number: CMS-10487 (OCN:
0938-NEW); Frequency: Annually; Affected Public: Individuals and
households; State, Local and Tribal governments; Business and other
for-profits and Not-for-profits; Number of Respondents: 93; Total
Annual Responses: 1,944; Total Annual Hours: 2,046. (For policy
questions regarding this collection contact Negussie Tilahun at 410-
786-2058.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Current
Beneficiary Survey; Use: We are the largest single payer of health care
in the United States. With full implementation of the Affordable Care
Act of 2010 (ACA), the agency will play a direct or indirect role in
administering health insurance coverage for more than 120 million
people across the Medicare, Medicaid, CHIP, and Exchange populations.
One of our critical aims is to be an effective steward, major force,
and trustworthy partner in leading the transformation of the health
care system. We also aim to provide Americans with high quality care
and better health at lower costs through improvement. At the forefront
of these initiatives is the newly formed Center for Medicare and
Medicaid Innovation (CMMI).
CMMI is authorized by Section 1115A of the Social Security Act, as
established by section 3021 of the ACA and was established to ``test
innovative payment and service delivery models to reduce program
expenditures. . .while preserving or enhancing the quality of care
furnished'' to Medicare, Medicaid and CHIP beneficiaries. Implicit
across all of CMMI activities is an emphasis on diffusion--finding and
validating innovative models that have the potential to scale,
facilitating rapid adoption, and letting them take root in
organizations, health systems, and communities across America.
The Medicare Current Beneficiary Survey (MCBS) is the most
comprehensive and complete survey available on the Medicare population
and is essential in capturing data not otherwise collected through our
operations. The MCBS is an in-person, nationally-representative,
longitudinal survey of Medicare beneficiaries that we sponsor and is
directed by the Office of Information Products and Data Analytics
(OIPDA) in partnership with the CMMI. The survey captures beneficiary
information whether aged or disabled, living in the community or
facility, or serviced by managed care or fee-for-service. Data produced
as part of the MCBS are enhanced with our administrative data (e.g.
fee-for-service claims, prescription drug event data, enrollment, etc.)
to provide users with more accurate and complete estimates of total
health care costs and utilization. The MCBS has been continuously
fielded for more than 20 years (encompassing over 1 million
interviews), and consists of three annual interviews per survey
participant.
The MCBS continues to provide unique insight into the Medicare
program and helps both us and our external stakeholders better
understand and evaluate the impact of existing programs and significant
new policy initiatives. In the past, MCBS data have been used to assess
potential changes to the Medicare program. For example, the MCBS was
instrumental in supporting the development and implementation of the
Medicare prescription drug benefit by providing a means to evaluate
prescription drug costs and out-of-pocket burden for these drugs to
Medicare beneficiaries. Form Number: CMS-P-0015A (OCN: 0938-0568);
Frequency: Occasionally; Affected Public: Business or other for-profits
and Not-for-profit institutions; Number of Respondents: 16,550; Total
Annual Responses: 49,650; Total Annual Hours: 58,450 (For policy
questions regarding
[[Page 45207]]
this collection contact William Long at 410-786-7927.)
4. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Advance Directives (Medicare and Medicaid) and Supporting
Regulations; Use: The advance directives requirement was enacted
because Congress wanted individuals to know that they have a right to
make health care decisions and to refuse treatment even when they are
unable to communicate. Steps have been taken at both the federal and
state level, to afford greater opportunity for the individual to
participate in decisions made concerning the medical treatment to be
received by an adult patient in the event that the patient is unable to
communicate to others, a preference about medical treatment. The
individual may make his preference known through the use of an advance
directive, which is a written instruction prepared in advance, such as
a living will or durable power of attorney. This information is
documented in a prominent part of the individual's medical record.
Advance directives as described in the Patient Self-Determination Act
have increased the individual's control over decisions concerning
medical treatment. Sections 4206 of the Omnibus Budget Reconciliation
Act of 1990 defined an advance directive as a written instruction
recognized under State law relating to the provision of health care
when an individual is incapacitated (those persons unable to
communicate their wishes regarding medical treatment).
All states have enacted legislation defining a patient's right to
make decisions regarding medical care, including the right to accept or
refuse medical or surgical treatment and the right to formulate advance
directives. Participating hospitals, skilled nursing facilities,
nursing facilities, home health agencies, providers of home health
care, hospices, religious nonmedical health care institutions, and
prepaid or eligible organizations (including Health Care Prepayment
Plans (HCPPs) and Medicare Advantage Organizations (MAOs) such as
Coordinated Care Plans, Demonstration Projects, Chronic Care
Demonstration Projects, Program of All Inclusive Care for the Elderly,
Private Fee for Service, and Medical Savings Accounts must provide
written information, at explicit time frames, to all adult individuals
about: a) the right to accept or refuse medical or surgical treatments;
b) the right to formulate an advance directive; c) a description of
applicable State law (provided by the State); and d) the provider's or
organization's policies and procedures for implementing an advance
directive. Form Number: CMS-R-10 (OCN: 0938-0610); Frequency: Yearly;
Affected Public: Business or other for-profits; Number of Respondents:
39,575; Total Annual Responses: 39, 575; Total Annual Hours: 2,836,441.
(For policy questions regarding this collection contact Sonia Swancy at
410-786-8445.)
5. Type of Information Collection Request: Extension of a currently
approved collection.
Title of Information Collection: Prospective Payments for Hospital
Outpatient Services and Supporting Regulations; Use: The Secretary is
required to establish a prospective payment system (PPS) for hospital
outpatient services. Successful implementation of an outpatient PPS
(OPPS) requires that we distinguish facilities or organizations that
function as departments of hospitals from those that are freestanding.
In this regard, we will be able to determine: which services should be
paid under the OPPS, the clinical laboratory fee schedule, or other
payment provisions applicable to services furnished to hospital
outpatients. Information from 42 CFR 413.65(b)(3) and (c) reports is
needed to make these determinations. Additionally, hospitals and other
providers are authorized to impose deductible and coinsurance charges
for facility services, but does not allow such charges by facilities or
organizations which are not provider-based. This provision requires
that we collect information from the required reports so it can
determine which facilities are provider-based. Form Number: CMS-R-240
(OCN: 0938-0798). Frequency: Occasionally; Affected Public: Private
sector--Business or other for-profits and Not-for-profit institutions;
Number of Respondents: 905; Total Annual Responses: 500,405; Total
Annual Hours: 26,563. (For policy questions regarding this collection
contact Daniel Schroder at 410-786-7452.)
6. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Participation for Comprehensive Outpatient
Rehabilitation Facilities (CORFs) and Supporting Regulations; Use: The
Conditions of Participation (CoPs) and accompanying requirements
specified in the regulations are used by our surveyors as a basis for
determining whether a comprehensive outpatient rehabilitation facility
(CORF) qualifies to be awarded a Medicare provider agreement. We
believe the health care industry practice demonstrates that the patient
clinical records and general content of records are necessary to ensure
the well-being and safety of patients and that professional treatment
and accountability are a normal part of industry practice. Form Number:
CMS-10282 (OCN: 0938-1091); Frequency: Yearly; Affected Public: Private
sector--Business or other for-profit and Not-for-profit institutions;
Number of Respondents: 314; Total Annual Responses: 314; Total Annual
Hours: 8,076. (For policy questions regarding this collection contact
Jacqueline Leach at 410-786-4282.)
7. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Final Peer Review Organizations Sanction Regulations in 42
CFR Sections 1004.40, 1004.50, 1004.60, and 1004.70; Use: The Peer
Review Improvement Act of 1982 amended Title XI of the Social Security
Act (the Act), creating the Utilization and Quality Control Peer Review
Organization Program. Section 1156 of the Act imposes obligations on
health care practitioners and others who furnish or order services or
items under Medicare. This section also provides for sanction actions,
if the Secretary determines that the obligations as stated by this
section are not met. Quality Improvement Organizations (QIOs) are
responsible for identifying violations. The QIOs may allow
practitioners or other entities, opportunities to submit relevant
information before determining that a violation has occurred. The
information collection requirements contained in this information
collection request are used by the QIOs to collect the information
necessary to make their decision. Form Number: CMS-R-65 (OCN: 0938-
0444); Frequency: On occasion; Affected Public: Private sector--
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 53; Total Annual Responses: 53; Total Annual Hours:
14,310. (For policy questions regarding this collection contact Coles
Mercier at 410-786-2112.)
8. Type of Information Collection Request: New collection (Request
for a new OMBcontrol number); Title of Information Collection:
Enrollment Assistance Program; Use: As required by the Affordable Care
Act, CMS will implement a grant-based Navigator Program to provide
support to targeted communities. However, there will also be a need for
broader based enrollment assistance in population centers that we
identify in states with Federally-facilitated Marketplaces (FFMs) to
provide Health Insurance Marketplace
[[Page 45208]]
enrollment assistance to populations not covered or targeted by the
Navigator Program. The target populations are individual consumers and
families eligible to enroll in Qualified Health Plans (QHPs) in
population centers we identify. Without such access to in-person
enrollment assistance, millions of individuals who will be eligible for
health insurance coverage in the Marketplaces might not have access to
the direct assistance required to make educated choices on available
healthcare options and may therefore be unable to successfully enroll
in the Marketplaces. To monitor program effectiveness, the Enrollment
Assistance Program will provide weekly, monthly, quarterly and annual
reports to us. Form Number: CMS-10491 (OCN: 0938-NEW); Frequency:
Weekly, Monthly, Quarterly, Yearly; Affected Public: Private Sector;
Number of Respondents: 1; Number of Responses: 84; Total Annual Hours:
554. (For policy questions regarding this collection contact Eliza
Bangit at 301-492-4219.)
Dated: July 23, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-17985 Filed 7-25-13; 8:45 am]
BILLING CODE 4120-01-P