[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