Agency Information Collection Activities: Proposed Collection; Comment Request
| Citation | 84 FR 41991 |
| Record Number | 2019-17663 |
| Published date | 16 August 2019 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 84 Issue 159 (Friday, August 16, 2019)
[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Notices]
[Pages 41991-41993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17663]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10137 and CMS-10191]
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 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 October 15, 2019.
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.
[[Page 41992]]
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. 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: 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-10137 Title Solicitation for Applications for Medicare Prescription
Drug Plan 2021 Contracts
CMS-10191 Medicare Parts C and D Program Audit Protocols and Data
Requests
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: Solicitation for
Applications for Medicare Prescription Drug Plan 2021 Contracts; Use:
Coverage for the prescription drug benefit is provided through
contracted prescription drug plans (PDPs) or through Medicare Advantage
(MA) plans that offer integrated prescription drug and health care
coverage (MA-PD plans). Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP)
may also provide a Part D benefit. Organizations wishing to provide
services under the Prescription Drug Benefit Program must complete an
application, negotiate rates, and receive final approval from CMS.
Existing Part D Sponsors may also expand their contracted service area
by completing the Service Area Expansion (SAE) application.
Collection of this information is mandated in Part D of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) in Subpart 3. The application requirements are codified in
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts
with PDP Sponsors.''
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for
the Elderly (PACE), and EGWP applicants. The collected information will
be used by CMS to: (1) Ensure that applicants meet CMS requirements for
offering Part D plans (including network adequacy, contracting
requirements, and compliance program requirements, as described in the
application), (2) support the determination of contract awards. Form
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 243; Total Annual Responses: 290; Total Annual Hours:
1,384.79. (For policy questions regarding this collection contact
Arianne Spaccarelli at 410-786-5715.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Parts C
and D Program Audit Protocols and Data Requests; Use: Under the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
and implementing regulations at 42 CFR parts 422 and 423, Medicare Part
D plan sponsors and Medicare Advantage organizations are required to
comply with all Medicare Parts C and D program requirements. CMS'
annual audit plan ensures that we evaluate sponsoring organizations'
compliance with these requirements. CMS program audits focus on high-
risk areas that have the greatest potential for beneficiary harm. As
such, CMS has developed several audit protocols that are included
within the program area data request documents and that are posted to
the CMS website each year for use by sponsoring organizations to
prepare for their audit. As part of a robust audit process, CMS also
requires sponsoring organizations who have been audited and found to
have deficiencies to undergo a validation audit to ensure correction.
The validation audit utilizes the same audit protocols, but only tests
the elements where deficiencies were found, as opposed to re-
administering the entire audit.
Currently CMS utilizes the following 5 protocols to audit
sponsoring organization performance: Part D Formulary and Benefit
Administration (FA); Coverage Determinations, Appeals, and Grievances
(CDAG); Organization Determinations, Appeals, and Grievances (ODAG);
Special Needs Model of Care (SNP-MOC) (only administered on
organizations who operate SNPs); and, Compliance Program Effectiveness
(CPE). The data collected is detailed in each of these protocols and
the exact fields are located in the record layouts, at the end of each
protocol. In addition, this collection request includes a pre-audit
issue summary, three CPE questionnaires, one CPE organizational
structure presentation template, one FA impact analysis template, two
CDAG impact analysis templates, four OAG impact analysis templates, and
three SNP-MOC impact analysis templates.
The information gathered during this audit will be used by the
Medicare Parts C and D Oversight and Enforcement Group (MOEG) within
the Center for Medicare (CM) and CMS Regional Offices to assess
sponsoring organizations' compliance with Medicare program
requirements. If outliers or other data anomalies are detected,
Regional Offices will work in collaboration with (MOEG) and other
divisions within CMS for follow-up and resolution. Additionally, MA and
Part D organizations will receive the audit results and will be
required to implement corrective action to correct any identified
deficiencies. Form Number: CMS-10191 (OMB control number: 0938-1000);
Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 201; Total Annual Responses: 207;
Total Annual Hours: 17,525. (For policy questions regarding this
collection contact Brenda Hudson at 303-844-7056.)
[[Page 41993]]
Dated: August 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-17663 Filed 8-15-19; 8:45 am]
BILLING CODE 4120-01-P
