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[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67150-67153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26822]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10171, CMS-10207, CMS-10476, CMS-10497, CMS-
10482, CMS-R-245 and CMS-10495]

Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by December 9, 2013.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974 OR Email: OIRA-- 
submission@omb.eop.gov.
    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,

[[Page 67151]]

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: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Coordination of 
Benefits Between Part D Plans and Other Prescription Coverage 
Providers; Use: We will use the information along with Part D plans, 
other health insurers or payers, and pharmacies to coordinate 
prescription drug benefits provided to Medicare beneficiaries. Form 
Number: CMS-10171 (OCN: 0938-0978); Frequency: Occasionally; Affected 
Public: Private sector--Business or other for-profits; Number of 
Respondents: 57,116; Total Annual Responses: 2,402,582; Total Annual 
Hours: 5,205,128. (For policy questions regarding this collection 
contact Heather Rudo at 410-786-7627.)
    2. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Physician Self-Referral Exceptions for Electronic 
Prescribing and Electronic Health Records; Use: The collected 
information would be used for enforcement purposes. Specifically, if we 
were investigating the financial relationships between donors and 
physicians to determine whether the provisions in the exceptions at 42 
CFR 411.357 (v) and (w) were met, first, we would review the written 
agreements that indicate what items and services each entity intended 
to provide. Form Number: CMS-10207 (OCN: 0938-1009); Frequency: 
Monthly; Affected Public: Private sector--Business or other for-profits 
and Not-for-profit institutions; Number of Respondents: 9,409; Total 
Annual Responses: 17,744; Total Annual Hours: 1,896. (For policy 
questions regarding this collection contact Michael Zleit at 410-786-
2050.)
    3. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Medical 
Loss Ratio (MLR) Report for Medicare Advantage (MA) Plans and 
Prescription Drug Plans (PDP); Use: We will use the data collection of 
annual reports provided by plan sponsors for each contract to ensure 
that beneficiaries are receiving value for their premium dollar by 
calculating each contract's medical loss ratio (MLR) and any 
remittances due for the respective MLR reporting year. The 
recordkeeping requirements will be used to determine plan sponsors' 
compliance with the MLR requirements, including compliance with how 
plan sponsors' experience is to be reported, and how their MLR and any 
remittances are calculated. Form Number: CMS-10476 (OCN: 0938-New); 
Frequency: Yearly; Affected Public: Private sector--Business or other 
for-profits and Not-for-profit institutions; Number of Respondents: 
616; Total Annual Responses: 616; Total Annual Hours: 130,004. (For 
policy questions regarding this collection contact Ilina Chaudhuri at 
410-786-8628.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluation of the Medicare Health Care Quality (MHCQ) Demonstration 
Evaluation: Focus Group and Interview Protocols; Use: The Medicare 
Health Care Quality (MHCQ) Demonstration was developed to address 
concerns about the U.S. health care system, which typically fragments 
care while also encouraging both omissions in and duplication of care. 
To rectify this situation, Congress has directed us to test major 
changes to the delivery and payment systems to improve the quality of 
care while also increasing efficiency across the health care system. 
This would be achieved through several types of interventions: adoption 
and use of information technology and decision support tools by 
physicians and their patients, such as evidence-based medicine 
guidelines, best practice guidelines, and shared decision-making 
programs; reform of payment methodologies; improved coordination of 
care among payers and providers serving defined communities; 
measurement of outcomes; and enhanced cultural competence in the 
delivery of care.
    The MHCQ Demonstration programs are designed to examine the extent 
to which major, multifaceted changes to traditional Medicare's health 
delivery and financing systems lead to improvements in the quality of 
care provided to Medicare beneficiaries without increasing total 
program expenditures. Each demonstration site uses a different approach 
for changing health delivery and financing systems, but all share the 
goal of improving the quality and efficiency of medical care provided 
to Medicare beneficiaries. Focus groups and individual interviews will 
be conducted at 2 demonstration sites that are active in the 
demonstration: Gundersen Health System (GHS) and Meridian Health System 
(MHS).
    This MHCQ Demonstration evaluation will include analysis of both 
quantitative and qualitative sources of information. This multifaceted 
approach will enable this evaluation to consider a broad variety of 
evidence for evaluating the nature and impact of each site's 
interventions. We are seeking approval to conduct in-person focus 
groups and individual interviews with beneficiaries and their 
caregivers to inform our evaluation of the MHCQ Demonstration at the 
GHS and MHS demonstration sites. Form Number: CMS-10497 (OCN: 0938-
New); Frequency: Occasionally; Affected Public: Individuals or 
households; Number of Respondents: 36; Total Annual Responses: 36; 
Total Annual Hours: 108. (For policy questions regarding this 
collection contact Normandy Brangan at 410-786-6640.)
    5. Type of Information Collection Request: New Collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluation of the Physician Quality Reporting System (PQRS) and 
Electronic Prescribing (eRx) Incentive Program; Use: The Physician 
Quality Reporting System (PQRS) was first implemented in 2007 as an 
incentive for voluntary reporting of quality measures in accordance 
with a section of the Tax Relief and Health Care Act of 2006. The PQRS 
was further extended and enhanced by legislation such as the Medicare, 
Medicaid, and State Children's Health Insurance Program (SCHIP) 
Extension Act of 2007 (MMSEA) and the Medicare Improvements for 
Patients and Providers Act of 2008 (MIPPA). A number of changes have 
been made to the PQRS, including group measures, the group reporting 
option, and

[[Page 67152]]

additional measures. The PQRS was extended further with the enactment 
of MMSEA. The MMSEA provided professionals greater flexibility for 
participating in the PQRS for 2008 and 2009 by authorizing us to 
establish alternative reporting criteria and alternative reporting 
periods for the reporting measures groups and for the submission of 
data on the PQRS quality measures through clinical data registries. The 
MIPPA, enacted in July 2008, made the PQRS program permanent, further 
enhanced the PQRS, and established a new standalone incentive program 
for successful electronic prescribers.
    The eRx Incentive Program, the other program being evaluated in 
this project, was first implemented in 2009. The eRx is another 
incentive reporting program that uses a combination of incentive 
payments and payment adjustments to encourage eRx by eligible 
professionals. The program provides an incentive payment to practices 
with eligible professionals who successfully e-prescribe for covered 
Physician Fee Schedule services furnished to Medicare Part B Fee-For-
Service (FFS) beneficiaries. Eligible professionals do not need to 
participate in PQRS to participate in the eRx Incentive Program.
    In support of an evaluation the PQRS and the eRx Incentive Program, 
we will conduct three surveys. The surveys will include: Medicare 
beneficiaries, eligible professionals, and administrators. This 
evaluation is designed to determine how well the PQRS and the eRx 
Incentive Program are contributing to better and affordable health care 
for Medicare beneficiaries. The PQRS is a voluntary reporting program 
that provides an incentive payment to eligible professionals who 
satisfactorily report data on quality measures. We use quality measures 
to promote improvements in care delivery and payment and to increase 
transparency. The PQRS program rewards eligible professionals based on 
a percentage of the estimated Medicare Physician Fee Schedule of their 
allowed Part B charges if they meet the defined reporting requirements. 
The PQRS was initially referred to as the Physician Quality Reporting 
Initiative (PQRI).
    Subsequent to the publication of the 60-day Federal Register notice 
(78 FR 35936), there has been an increase in burden due to the increase 
in the sample size of eligible professionals and administrators. Also, 
the surveys have been changed by revising lists of specialties and 
revising questions. Form Number: CMS-10482 (OCN: 0938-NEW); Frequency: 
Yearly; Affected Public: Individuals and households, Private sector--
Business or other for-profits and Not-for-profit institutions; Number 
of Respondents: 12,650; Total Annual Responses: 12,650; Total Annual 
Hours: 3,805. (For policy questions regarding this collection contact 
Lauren Fuentes at 410-786-2290.)
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: OASIS Collection 
Requirements as Part of the CoPs for HHAs and Supporting Regulations; 
Use: The Outcome and Assessment Information Set (OASIS) is currently 
mandated for use by Home Health Agencies (HHAs) as a condition of 
participation (CoP) in the Medicare program. Since 1999, the Medicare 
CoPs have mandated that HHAs use the OASIS data set when evaluating 
adult non-maternity patients receiving skilled services. The OASIS is a 
core standard assessment data set that agencies integrate into their 
own patient-specific, comprehensive assessment to identify each 
patient's need for home care that meets the patient's medical, nursing, 
rehabilitative, social, and discharge planning needs. Subsequent to the 
publication of the 60-day Federal Register notice (78 FR 37542), the 
data set was revised by rewording the text. Form Number: CMS-R-245 
(OCN: 0938-0760); Frequency: Occasionally; Affected Public: Private 
Sector--Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 12,014; Total Annual Responses: 17,268,890; 
Total Annual Hours: 15,305,484. (For policy questions regarding this 
collection contact Robin Dowell at 410-786-0060.)
    7. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Registration, Attestation, Dispute & Resolution, Assumptions Document 
and Data Retention Requirements for Open Payments; Use: Section 6002 of 
the Affordable Care Act added section 1128G to the Social Security Act 
(Act), which requires applicable manufacturers and applicable group 
purchasing organizations (GPOs) of covered drugs, devices, biologicals, 
or medical supplies to report annually to CMS certain payments or other 
transfers of value to physicians and teaching hospitals, as well as, 
certain information regarding the ownership or investment interests 
held by physicians or their immediate family members in applicable 
manufacturers or applicable GPOs.
    Specifically, applicable manufacturers of covered drugs, devices, 
biologicals, and medical supplies are required to submit on an annual 
basis the information required in section 1128G(a)(1) of the Act about 
certain payments or other transfers of value made to physicians and 
teaching hospitals (collectively called covered recipients) during the 
course of the preceding calendar year. Similarly, section 1128G(a)(2) 
of the Act requires applicable manufacturers and applicable GPOs to 
disclose any ownership or investment interests in such entities held by 
physicians or their immediate family members, as well as information on 
any payments or other transfers of value provided to such physician 
owners or investors. Applicable manufacturers must report the required 
payment and other transfer of value information annually to CMS in an 
electronic format. The statute also provides that applicable 
manufacturers and applicable GPOs must report annually to CMS the 
required information about physician ownership and investment 
interests, including information on any payments or other transfers of 
value provided to physician owners or investors, in an electronic 
format by the same date. Applicable manufacturers and applicable GPOs 
are subject to civil monetary penalties (CMPs) for failing to comply 
with the reporting requirements of the statute. We are required by 
statute to publish the reported data on a public Web site. The data 
must be downloadable, easily searchable, and aggregated. In addition, 
we must submit annual reports to the Congress and each state 
summarizing the data reported. Finally, section 1128G of the Act 
generally preempts state laws that require disclosure of the same type 
of information by manufacturers.
    We published a final rule in 2013 to implement this program, which 
included several information collections subject to the Paperwork 
Reduction Act. This information collection request is to inform the 
public about information collected that is necessary for registration, 
attestation, dispute resolution and corrections, record retention, and 
submitting an assumptions document within Open Payments. Form Number: 
CMS-10495 (OCN: 0938-New); Frequency: Once; Affected Public: Private 
sector--Business or other for-profits; Number of Respondents: 451,582; 
Total Annual Responses: 451,582; Total Annual Hours: 949,005. (For 
policy questions regarding this collection contact Melissa Heesters at 
410-786-0618.)

[[Page 67153]]

    Dated: November 5, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-26822 Filed 11-7-13; 8:45 am]
BILLING CODE 4120-01-P
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