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[Federal Register Volume 78, Number 144 (Friday, July 26, 2013)]
[Notices]
[Pages 45205-45208]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17985]

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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.

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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 Paperwork@cms.hhs.gov.
    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
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