Agency Information Collection Activities: Proposed Collection; Comment Request
| Citation | 85 FR 58360 |
| Record Number | 2020-20561 |
| Published date | 18 September 2020 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
Federal Register, Volume 85 Issue 182 (Friday, September 18, 2020)
[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58360-58362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20561]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10443, CMS-10265, CMS-10171, and CMS-10291]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
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 the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and 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 17, 2020.
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' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
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-10443 Transcatheter Valve Therapy (TVT) Registry
CMS-10265 Mandatory Insurer Reporting Requirements of Section 111 of
the Medicare, Medicaid and SCHIP Act of 2007
CMS-10171 Part D Coordination of Benefits Data
CMS-10291 State Collection and Reporting of Dental Provider and Benefit
Package Information on the Insure Kids Now! Website and Hotline
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: Extension of a
previously approved collection: Title of Information Collection:
Transcatheter Valve Therapy (TVT) Registry; Use: The data collection is
required by the Centers for Medicare and Medicaid Services (CMS)
National Coverage Determination (NCD) entitled, ``Transcatheter Aortic
Valve Replacement (TAVR)''. The TAVR device is only covered when
specific conditions are met including that the heart team and hospital
are submitting data in a prospective, national, audited registry. The
data includes patient, practitioner and facility level variables that
predict outcomes such as all cause mortality and quality of life. CMS
finds that the Society of Thoracic Surgery/American College of
Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one
registry overseen by the National Cardiovascular Data Registry, meets
the requirements specified in the NCD on TAVR. The TVT Registry will
support a national
[[Page 58361]]
surveillance system to monitor the safety and efficacy of the TAVR
technologies for the treatment of aortic stenosis.
The data will also include the variables on the eight item Kansas
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status,
functioning and quality of life. In the KCCQ, an overall summary score
can be derived from the physical function, symptoms (frequency and
severity), social function and quality of life domains. For each
domain, the validity, reproducibility, responsiveness and
interpretability have been independently established. Scores are
transformed to a range of 0-100, in which higher scores reflect better
health status.
The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in
accordance with Section 1142 of the Social Security Act (the Act) that
describes the authority of the Agency for Healthcare Research and
Quality (AHRQ). Under section 1142, research may be conducted and
supported on the outcomes, effectiveness, and appropriateness of health
care services and procedures to identify the manner in which disease,
disorders, and other health conditions can be prevented, diagnosed,
treated, and managed clinically. Section 1862(a)(1)(E) of the Act
allows Medicare to cover under coverage with evidence development (CED)
certain items or services for which the evidence is not adequate to
support coverage under section 1862(a)(1)(A) and where additional data
gathered in the context of a clinical setting would further clarify the
impact of these items and services on the health of beneficiaries.
The data collected and analyzed in the TVT Registry will be used by
CMS to determine if the TAVR is reasonable and necessary (e.g.,
improves health outcomes) for Medicare beneficiaries under Section
1862(a)(1)(A) of the Act. Furthermore, data from the Registry will
assist the medical device industry and the Food and Drug Administration
(FDA) in surveillance of the quality, safety and efficacy of new
medical devices to treat aortic stenosis. For purposes of the TAVR NCD,
The TVT Registry has contracted with the Data Analytic Centers to
conduct the analyses. In addition, data will be made available for
research purposes under the terms of a data use agreement that only
provides de-identified datasets. Form Number: CMS-10443 (OMB control
number: 0938-1202); Frequency: Annual; Affected Public: Individuals,
Households and Private Sector; Number of Respondents: 37,221; Total
Annual Responses: 148,884; Total Annual Hours: 47,765. (For policy
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)
2. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection:
Mandatory Insurer Reporting Requirements of Section 111 of the
Medicare, Medicaid and SCHIP Act of 2007; Use: The Centers for Medicare
& Medicaid Services (CMS) collects various data elements from the
applicable reporting entities (see supporting documents) for purposes
of carrying out the mandatory MSP reporting requirements of Section
111of the Medicare, Medicaid and SCHIP Extension Act. This information
is used to ensure that Medicare makes payment in the proper order and/
or takes necessary recovery actions. 42 U.S.C. 1395y(b)(7)(A)(i)(II)
was updated by the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities
Act. Section 4002 of the SUPPORT Act also applies to Section 111 that
requires Group Health Plan (GHP) reporting of primary prescription drug
coverage.
MSP is generally divided into ``pre-payment'' and ``post-payment''
activities. Pre-payment activities are generally designed to stop
mistaken primary payments in situations where Medicare should be
secondary. Medicare post-payment activities are designed to recover
mistaken payments or conditional payments made by Medicare where there
is a contested liability insurance (including self-insurance), no-fault
insurance, or workers' compensation which has resulted in a settlement,
judgment, award, or other payment. CMS specialty contractors perform
most of the MSP activity.
Pre-payment
The information is collected from applicable reporting entities for
the purpose of coordination of benefits and the recovery of mistaken
and conditional payments. Section 111 mandates the reporting of
information in the form and manner specified by the Secretary, DHHS.
Data the Secretary collects is necessary for both pre-payment and post-
payment coordination of benefit purposes, including necessary recovery
actions.
Both GHP and NGHP entities have had and continue to have the
responsibility for determining when they are primary to Medicare and to
pay appropriately, even without the mandatory Section 111 process,
Insurers should always collect the NGHP, GHP and GHP prescription drug
information that CMS requires in connection with Section 111 of the
MMSEA. Form Number: CMS-10265 (OMB control number: 0938-1074);
Frequency: Yearly; Affected Public: Private Sector, Business or other
for-profits; Number of Respondents: 21,141; Total Annual Responses:
8,079,697; Total Annual Hours: 618,060. (For policy questions regarding
this collection contact Richard Mazur at 410-786-1418.)
3. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection: Part
D Coordination of Benefits Data; Use: Sections 1860D-23 and 1860D-24 of
the Act require the Secretary to establish requirements for
prescription drug plans to promote effective coordination between Part
D plans and SPAPs and other payers. These Part D Coordination of
Benefits (COB) requirements have been codified into the Code of Federal
Regulations at 42 CFR 423.464. In particular, CMS' requirements relate
to the following elements: (1) Enrollment file sharing; (2) claims
processing and payment; (3) claims reconciliation reports; (4)
application of the protections against high out-of-pocket expenditures
by tracking TrOOP expenditures; and (5) other processes that the
Secretary determines.
This information collection assists CMS, pharmacists, Part D plans,
and other payers coordinate prescription drug benefits at the point-of-
sale and track beneficiary True out-of-pocket (TrOOP) expenditures
using the Part D Transaction Facilitator (PDTF).
The collected information will be used by Part D plans, other
health insurers or payers, pharmacies and CMS to coordinate
prescription drug benefits provided to the Medicare beneficiary. Part D
plans share data with each other and with CMS. The types of data
collected for sharing include enrollment data, other health insurance
information, TrOOP and Gross drug spending and supplemental payer data.
Form Number: CMS-10171 (OMB control number: 0938-0978); Frequency:
Yearly; Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 63,910; Total Annual Responses: 770,855,926; Total Annual
Hours: 938,065. (For policy questions regarding this collection contact
Chad Buskirk at 410-786-1630.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: State Collection
and Reporting of Dental Provider and Benefit Package Information on the
Insure Kids Now! Website and Hotline; Use: On the Insure Kids Now (IKN)
[[Page 58362]]
website, the Secretary is required to post a current and accurate list
of dentists and providers that provide dental services to children
enrolled in the state plan (or waiver) under Medicaid or the state
child health plan (or waiver) under CHIP. States collect the
information pertaining to their Medicaid and CHIP dental benefits. Form
Number: CMS-10291 (OMB control number: 0938-1065); Frequency: Yearly
and quarterly; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 51; Total Annual Responses: 255; Total Annual
Hours: 11,781. (For policy questions regarding this collection contact
Andrew Snyder at 410-786-1274.)
Dated: September 14, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-20561 Filed 9-17-20; 8:45 am]
BILLING CODE 4120-01-P
