[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57826-57827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10519 and CMS-10583]


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 November 24, 2015.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. 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-10519 Physician Quality Reporting System (PQRS) and the Electronic 
Prescribing Incentive (eRx) Program Data Assessment, Accuracy and 
Improper Payments Identification Support
CMS-10583 Data Collection for Medicare Beneficiaries Receiving Beta 
Amyloid Positron Emission Tomography (PET) for Dementia and 
Neurodegenerative Disease
    Under the 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 Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Physician

[[Page 57827]]

Quality Reporting System (PQRS) and the Electronic Prescribing 
Incentive (eRx) Program Data Assessment, Accuracy and Improper Payments 
Identification Support; Use: The incentive and reporting programs have 
data integrity issues, such as rejected and improper payments. This 
four year project will evaluate incentive payment information for 
accuracy and identify improper payments, with the goal of recovering 
these payments. Additionally, based on the project's results, 
recommendations will be made so that we can avoid future data integrity 
issues.
    Data submission, processing, and reporting will be analyzed for 
potential errors, inconsistencies, and gaps that are related to data 
handling, program requirements, and clinical quality measure 
specifications of PQRS and eRx program. Surveys of Group Practices, 
Registries, and Data Submission Vendors (DSVs) will be conducted in 
order to evaluate the PQRS and eRx Incentive Program. Follow-up 
interviews will occur with a small number of respondents. Form Number: 
CMS-10519 (OMB control number: 0938-1255); Frequency: Annually; 
Affected Public: Business or other for-profits; Number of Respondents: 
115; Total Annual Responses: 115; Total Annual Hours: 201. (For policy 
questions regarding this collection contact Timothy Jackson at 410-786-
4006.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Data 
Collection for Medicare Beneficiaries Receiving Beta Amyloid Positron 
Emission Tomography (PET) for Dementia and Neurodegenerative Disease 
Use: In the Decision Memorandum #CAG-00431N issued on September 27, 
2013, CMS determined there is sufficient evidence that the use of beta 
amyloid PET is promising in 2 scenarios: (1) to exclude Alzheimer's 
Disease (AD) in narrowly defined and clinically difficult differential 
diagnoses; and (2) to enrich clinical trials seeking better treatments 
or prevention strategies for AD. CMS will cover one beta amyloid PET 
scan per patient through Coverage with Evidence Development under 
section 1862(a)(1)(E) of the Social Security Act, in clinical studies 
that meet specific criteria established by CMS. Clinical studies must 
be approved by CMS, involve subjects from appropriate populations, and 
be comparative and longitudinal. Radiopharmaceuticals used in the scan 
must be FDA approved. Approved studies must address defined research 
questions established by CMS. Clinical studies in this National 
Coverage Determination (NCD) must adhere to the designated timeframe 
and meet standards establish by CMS in the NCD. Consistent with section 
1142 of the Social Security Act, the Agency for Healthcare and Quality 
(AHRQ) supports clinical research studies that CMS determines meet 
specifically identified requirements and research questions.
    To qualify for payment, providers must prescribe beta amyloid PET 
for beneficiaries with a set of clinical criteria specific to each 
cancer. Data elements will be transmitted to CMS for evaluation of the 
short and long-term benefits of beta amyloid PET to beneficiaries and 
for use in future clinical decision making. Form Number: CMS-10583 (OMB 
control number: 0938-NEW); Frequency: Annually; Affected Public: 
Private sector (Business or other for-profit); Number of Respondents: 
300; Total Annual Responses: 3,700; Total Annual Hours: 6,475. (For 
policy questions regarding this collection contact Stuart Caplan at 
410-786-8564).

    Dated: September 22, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-24474 Filed 9-24-15; 8:45 am]
 BILLING CODE 4120-01-P