[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