80 FR 57826 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 186 (September 25, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 186 (September 25, 2015)
| Page Range | 57826-57827 | |
| FR Document | 2015-24474 |
[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)] [Notices] [Pages 57826-57827] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24474] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![57826 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices
In that notice, we detailed our DEPARTMENT OF HEALTH AND 7500 Security Boulevard, Baltimore,
evaluation criteria. Under section HUMAN SERVICES Maryland 21244–1850.
1865(a)(2) of the Act and our regulations To obtain copies of a supporting
at § 410.142 and § 410.143, we Centers for Medicare & Medicaid statement and any related forms for the
conducted a review of ADA’s NAO Services proposed collection(s) summarized in
based on the criteria set forth in [Document Identifiers: CMS–10519 and this notice, you may make your request
§ 410.142(b), which include, but are not CMS–10583] using one of following:
limited to the following: (1) A review of 1. Access CMS’ Web site address at
the NAO’s operations and office to Agency Information Collection http://www.cms.hhs.gov/Paperwork
verify information in the organization’s Activities: Proposed Collection; ReductionActof1995.
Comment Request 2. Email your request, including your
application and assess the
address, phone number, OMB number,
organization’s compliance with its own AGENCY: Centers for Medicare & and CMS document identifier, to
policies and procedures; (2) evaluating Medicaid Services, HHS. Paperwork@cms.hhs.gov.
accreditation results or the accreditation ACTION: Notice. 3. Call the Reports Clearance Office at
status decision making process; and (3) (410) 786–1326.
interviewing the organization’s staff. SUMMARY: The Centers for Medicare &
FOR FURTHER INFORMATION CONTACT:
The April 30, 2015 proposed notice Medicaid Services (CMS) is announcing
Reports Clearance Office at (410) 786–
also solicited public comments on the an opportunity for the public to
1326.
ability of ADA to continue to develop comment on CMS’ intention to collect
information from the public. Under the SUPPLEMENTARY INFORMATION:
standards that meet or exceed the
Paperwork Reduction Act of 1995 (the Contents
Medicare conditions for coverage and
PRA), federal agencies are required to
apply them to accredit entities to This notice sets out a summary of the
publish notice in the Federal Register
furnish training. We received no public concerning each proposed collection of use and burden associated with the
comments in response to our proposed information (including each proposed following information collections. More
notice. extension or reinstatement of an existing detailed information can be found in
collection of information) and to allow each collection’s supporting statement
IV. Provisions of the Final Notice
60 days for public comment on the and associated materials (see
ADA’s application to continue as an proposed action. Interested persons are ADDRESSES).
accredited NAO to deem entities for the invited to send comments regarding our CMS–10519 Physician Quality
purposes of DSMT is approved for a burden estimates or any other aspect of Reporting System (PQRS) and the
period of 6 years. The accreditation is this collection of information, including Electronic Prescribing Incentive
effective on September 25, 2015. This any of the following subjects: (1) The (eRx) Program Data Assessment,
approval is subject to renewal necessity and utility of the proposed Accuracy and Improper Payments
subsequent to the receipt of an information collection for the proper Identification Support
performance of the agency’s functions; CMS–10583 Data Collection for
application from the ADA and subject to
(2) the accuracy of the estimated Medicare Beneficiaries Receiving
review, evaluation, and approval of its
burden; (3) ways to enhance the quality, Beta Amyloid Positron Emission
program. Tomography (PET) for Dementia
utility, and clarity of the information to
Based on our review and observations be collected; and (4) the use of and Neurodegenerative Disease
described in section III of this final automated collection techniques or Under the PRA (44 U.S.C. 3501–
notice, we approve ADA as a NAO for other forms of information technology to 3520), federal agencies must obtain
entities furnishing DSMT that request minimize the information collection approval from the Office of Management
participation in the Medicare program, burden. and Budget (OMB) for each collection of
effective September 25, 2015 through information they conduct or sponsor.
DATES: Comments must be received by The term ‘‘collection of information’’ is
effective September 27, 2021.
November 24, 2015. defined in 44 U.S.C. 3502(3) and 5 CFR
V. Collection of Information ADDRESSES: When commenting, please 1320.3(c) and includes agency requests
Requirements reference the document identifier or or requirements that members of the
OMB control number. To be assured public submit reports, keep records, or
This document does not impose consideration, comments and provide information to a third party.
information collection requirements, recommendations must be submitted in Section 3506(c)(2)(A) of the PRA
that is, reporting, recordkeeping or any one of the following ways: requires federal agencies to publish a
third-party disclosure requirements. 1. Electronically. You may send your 60-day notice in the Federal Register
Consequently, there is no need for comments electronically to http:// concerning each proposed collection of
review by the Office of Management and www.regulations.gov. Follow the information, including each proposed
Budget under the authority of the instructions for ‘‘Comment or extension or reinstatement of an existing
Paperwork Reduction Act of 1995 (44 Submission’’ or ‘‘More Search Options’’ collection of information, before
U.S.C. 3501 et seq.). to find the information collection submitting the collection to OMB for
Dated: September 17, 2015. document(s) that are accepting approval. To comply with this
mstockstill on DSK4VPTVN1PROD with NOTICES
comments. requirement, CMS is publishing this
Andrew M. Slavitt,
2. By regular mail. You may mail notice.
Acting Administrator, Centers for Medicare written comments to the following
& Medicaid Services. address: CMS, Office of Strategic Information Collection
[FR Doc. 2015–24358 Filed 9–24–15; 8:45 am] Operations and Regulatory Affairs, 1. Type of Information Collection
BILLING CODE 4120–01–P Division of Regulations Development, Request: Revision of a currently
Attention: Document Identifier/OMB approved collection; Title of
Control Number ____, Room C4–26–05, Information Collection: Physician
VerDate Sep<11>2014 19:58 Sep 24, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/80_FR_58012/page/1.svg)
![Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices 57827
Quality Reporting System (PQRS) and Clinical studies in this National FOR FURTHER INFORMATION CONTACT:Liz
the Electronic Prescribing Incentive Coverage Determination (NCD) must Hosna (Katherine.Hosna@cms.hhs.gov),
(eRx) Program Data Assessment, adhere to the designated timeframe and (410) 786–4993.
Accuracy and Improper Payments meet standards establish by CMS in the SUPPLEMENTARY INFORMATION:
Identification Support; Use: The NCD. Consistent with section 1142 of
incentive and reporting programs have the Social Security Act, the Agency for I. Background
data integrity issues, such as rejected Healthcare and Quality (AHRQ) Section 1869(b)(1)(E) of the Social
and improper payments. This four year supports clinical research studies that Security Act (the Act), as amended by
project will evaluate incentive payment CMS determines meet specifically section 521 of the Medicare, Medicaid,
information for accuracy and identify identified requirements and research and SCHIP Benefits Improvement and
improper payments, with the goal of questions. Protection Act of 2000 (BIPA),
recovering these payments. To qualify for payment, providers established the amount in controversy
Additionally, based on the project’s must prescribe beta amyloid PET for (AIC) threshold amounts for
results, recommendations will be made beneficiaries with a set of clinical Administrative Law Judge (ALJ) hearing
so that we can avoid future data criteria specific to each cancer. Data requests and judicial review at $100 and
integrity issues. elements will be transmitted to CMS for $1,000, respectively, for Medicare Part
Data submission, processing, and evaluation of the short and long-term A and Part B appeals. Section 940 of the
reporting will be analyzed for potential benefits of beta amyloid PET to Medicare Prescription Drug,
errors, inconsistencies, and gaps that are beneficiaries and for use in future Improvement, and Modernization Act of
related to data handling, program clinical decision making. Form Number: 2003 (MMA), amended section
requirements, and clinical quality CMS–10583 (OMB control number: 1869(b)(1)(E) of the Act to require the
measure specifications of PQRS and eRx 0938–NEW); Frequency: Annually; AIC threshold amounts for ALJ hearings
program. Surveys of Group Practices, Affected Public: Private sector (Business and judicial review to be adjusted
Registries, and Data Submission or other for-profit); Number of annually. The AIC threshold amounts
Vendors (DSVs) will be conducted in Respondents: 300; Total Annual are to be adjusted, as of January 2005,
order to evaluate the PQRS and eRx Responses: 3,700; Total Annual Hours: by the percentage increase in the
Incentive Program. Follow-up 6,475. (For policy questions regarding medical care component of the
interviews will occur with a small this collection contact Stuart Caplan at consumer price index (CPI) for all urban
number of respondents. Form Number: 410–786–8564). consumers (U.S. city average) for July
CMS–10519 (OMB control number: Dated: September 22, 2015. 2003 to July of the year preceding the
0938–1255); Frequency: Annually; William N. Parham, III, year involved and rounded to the
Affected Public: Business or other for- nearest multiple of $10. Section
Director, Paperwork Reduction Staff, Office
profits; Number of Respondents: 115; of Strategic Operations and Regulatory 940(b)(2) of the MMA provided
Total Annual Responses: 115; Total Affairs. conforming amendments to apply the
Annual Hours: 201. (For policy [FR Doc. 2015–24474 Filed 9–24–15; 8:45 am]
AIC adjustment requirement to
questions regarding this collection Medicare Part C/Medicare Advantage
BILLING CODE 4120–01–P
contact Timothy Jackson at 410–786– (MA) appeals and certain health
4006.) maintenance organization and
2. Type of Information Collection DEPARTMENT OF HEALTH AND competitive health plan appeals. Health
Request: New collection (Request for a HUMAN SERVICES care prepayment plans are also subject
new OMB control number); Title of to MA appeals rules, including the AIC
Information Collection: Data Collection Centers for Medicare & Medicaid adjustment requirement. Section 101 of
for Medicare Beneficiaries Receiving Services the MMA provides for the application of
Beta Amyloid Positron Emission the AIC adjustment requirement to
Tomography (PET) for Dementia and [CMS–4178–N]
Medicare Part D appeals.
Neurodegenerative Disease Use: In the Medicare Program; Medicare Appeals;
Decision Memorandum #CAG–00431N A. Medicare Part A and Part B Appeals
Adjustment to the Amount in
issued on September 27, 2013, CMS The statutory formula for the annual
Controversy Threshold Amounts for
determined there is sufficient evidence adjustment to the AIC threshold
Calendar Year 2016
that the use of beta amyloid PET is amounts for ALJ hearings and judicial
promising in 2 scenarios: (1) to exclude AGENCY: Centers for Medicare & review of Medicare Part A and Part B
Alzheimer’s Disease (AD) in narrowly Medicaid Services (CMS), HHS. appeals, set forth at section
defined and clinically difficult ACTION: Notice. 1869(b)(1)(E) of the Act, is included in
differential diagnoses; and (2) to enrich the applicable implementing
clinical trials seeking better treatments SUMMARY: This notice announces the regulations, 42 CFR 405.1006(b) and (c).
or prevention strategies for AD. CMS annual adjustment in the amount in The regulations require the Secretary of
will cover one beta amyloid PET scan controversy (AIC) threshold amounts for the Department of Health and Human
per patient through Coverage with Administrative Law Judge (ALJ) Services (the Secretary) to publish
Evidence Development under section hearings and judicial review under the changes to the AIC threshold amounts
1862(a)(1)(E) of the Social Security Act, Medicare appeals process. The in the Federal Register
in clinical studies that meet specific adjustment to the AIC threshold (§ 405.1006(b)(2)). In order to be entitled
amounts will be effective for requests
mstockstill on DSK4VPTVN1PROD with NOTICES
criteria established by CMS. Clinical to a hearing before an ALJ, a party to a
studies must be approved by CMS, for ALJ hearings and judicial review proceeding must meet the AIC
involve subjects from appropriate filed on or after January 1, 2016. The requirements at § 405.1006(b). Similarly,
populations, and be comparative and calendar year 2016 AIC threshold a party must meet the AIC requirements
longitudinal. Radiopharmaceuticals amounts are $150 for ALJ hearings and at § 405.1006(c) at the time judicial
used in the scan must be FDA approved. $1,500 for judicial review. review is requested for the court to have
Approved studies must address defined DATES: Effective Date: This notice is jurisdiction over the appeal
research questions established by CMS. effective on January 1, 2016. (§ 405.1136(a)).
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Document Created: 2018-02-26 10:19:30
Document Modified: 2018-02-26 10:19:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by November 24, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 57826 |
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