Agency Information Collection Activities: Submission for OMB Review; Comment Request, 34450-34451 [2020-12002]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Pages 34450-34451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10717, CMS-10468 and CMS-R-267]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by July 6, 2020.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 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 Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: New Collection; Title of 
Information Collection: Medicare Part C and Part D Program Audit and 
Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols; 
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 by 
conducting program audits that focus on high-risk areas that have the 
greatest potential for beneficiary harm. As such, CMS has developed the 
following audit protocols for use by Sponsoring organizations to 
prepare for their audit:
 Compliance Program Effectiveness (CPE)
 Part D Formulary and Benefit Administration (FA)
 Part D Coverage Determinations, Appeals, and Grievances (CDAG)
 Part C Organization Determinations, Appeals, and Grievances 
(ODAG)
 Special Needs Plans Care Coordination (SNPCC)

    CMS generally conducts program audits at the parent organization 
level in an effort to reduce burden and, for routine audits, subjects 
each Sponsoring organization to all applicable program area protocols. 
For example, if a Sponsoring organization does not offer a special 
needs plan, or an accrediting organization has deemed a special needs 
plan compliant with CMS regulations and standards, CMS would not apply 
the SNPCC protocol. Likewise, CMS would not apply the ODAG audit 
protocol to an organization that offers only a standalone prescription 
drug plan since that organization does not offer the MA benefit. 
Conversely, ad hoc audits resulting from referral may be limited in 
scope and, therefore, all program area protocols may not be applied.
    In addition, as part of the robust program audit process, CMS also 
requires sponsoring organizations that have undergone a program audit 
and found to have deficiencies to undergo a validation audit to ensure 
correction. The validation audit uses the same audit protocols, but 
only tests the elements where deficiencies were found as opposed to re-
administering the entire audit. Finally, CMS conducts annual industry-
wide timeliness monitoring of all Part C organizations by using a 
subset of the ODAG protocol. However, Sponsoring organizations that 
successfully submitted all of their Part C data in response to a 
program audit in the prior year are excluded from submitting new data 
for the timeliness monitoring effort in the year following their 
program audit.
    The information gathered during this program audit will be used by 
the Medicare Parts C and D Oversight and Enforcement Group (MOEG) 
within the Center for Medicare (CM) and CMS

[[Page 34451]]

Regional Offices to assess Sponsoring organizations' compliance with 
Medicare program requirements. If outliers or other data anomalies are 
detected, MOEG requires audited organizations to provide impact 
analyses to better understand and report the scope of the 
noncompliance. These MA and Part D organizations then receive their 
audit results, are required to implement corrective actions, and to 
demonstrate correction of all conditions cited in the final audit 
report by undergoing a validation audit. If the validation audit 
demonstrates substantial correction of the conditions, MOEG will 
communicate its decision to close the audit in a letter to the MA and 
Part D organization. Any new or isolated issues of non-compliance that 
remain will be referred to the CMS Account Manager for follow-up. 
Regional Offices will work in collaboration with MOEG and other 
divisions within CMS for resolution. Form Number: CMS-10717 (OMB 
control number: 0938-New); Frequency: Yearly; Affected Public: Private 
Sector, Business or other for-profits, Not-for-profits institutions; 
Number of Respondents: 190; Total Annual Responses: 179; Total Annual 
Hours: 36,082. (For policy questions regarding this collection contact 
Kellie Simons at 410-786-0886.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Essential Health Benefits in Alternative Benefit Plans, Eligibility 
Notices, Fair Hearing and Appeal Processes, and Premiums and Cost 
Sharing; Exchanges: Eligibility and Enrollment; Use: The Exchanges, 
which became operational on January 1, 2014, enhanced competition in 
the health insurance market, expanded access to affordable health 
insurance for millions of Americans, and provided consumers with a 
place to easily compare and shop for health insurance coverage. The 
reporting requirements and data collection in Medicaid, Children's 
Health Insurance Programs, and Exchanges: Essential Health Benefits in 
Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal 
Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and 
Enrollment (CMS-2334-F) address: (1) Standards related to notices, (2) 
procedures for the verification of enrollment in an eligible employer-
sponsored plan and eligibility for qualifying coverage in an eligible 
employer-sponsored plan; and (3) other eligibility and enrollment 
provisions to provide detail necessary for state implementation. The 
submission seeks OMB approval of the information collection 
requirements associated with selected provisions in 45 CFR parts 155, 
156 and 157. Form Number: CMS-10468 (OMB control number: 0938-1207); 
Frequency: Annually; Affected Public: Individuals, Households and 
Private Sector; Number of Respondents: 1,522; Total Annual Responses: 
9,533; Total Annual Hours: 103,710. (For policy questions regarding 
this collection contact Anne Pesto at 410-786-3492.)
    3. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Medicare Plus Choice Program Requirements Referenced in 42 CFR 422.000-
422.700; Use: The information collection requirements are mandated by 
42 CFR part 422. Section 4001 of the Balanced Budget Act of 1997 (BBA) 
added sections 1851 through 1859 to the Social Security Act to 
establish the Managed Care program. The Medicare, Medicaid, and SCHIP 
Benefits Improvement Act and Protection Act of 2000, Public Law 106-554 
added requirements to the Managed Care program. The Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 
108-173) created the Medicare Advantage program.
    A major goal of the Medicare Advantage program is to provide ease 
of access for Original Medicare beneficiaries who wish to enroll in a 
Medicare Advantage program. Certain populations of beneficiaries such 
as the dually eligible population (those beneficiaries enrolled in both 
Medicaid and Medicare) have grown since the program was created and 
these populations require more flexibilities.
    MA organizations (formerly M+C organizations) and potential MA 
organizations (applicants) use the information collected based on the 
regulations at 42 CFR part 422 to comply with the application 
requirements and the MA contract requirements. CMS uses the information 
collected based on the regulations at 42 CFR part 422 to approve 
contract applications, monitor compliance with contract requirements, 
make proper payment to MA organizations, determine compliance with the 
new prescription drug benefit requirements established by the MMA, and 
to ensure that correct information is disclosed to Medicare 
beneficiaries, both potential enrollees and enrollees.
    Information supplied by organizations is used to determine 
eligibility for contracting with CMS, for determining compliance with 
contract requirements, and for calculating proper payment to the 
organizations. Information supplied by Medicare beneficiaries is used 
to determine eligibility to enroll in the M+C organization and to 
determine proper payment to the organization that enrolled the 
beneficiary. Separate OMB approval was sought for each form as 
required.
    The information collection request also incorporates the new 
minimum criteria for dual eligible special needs plans (D-SNPs) to 
integrate Medicare and Medicaid benefits detailed in Section 50311(b) 
of the Bipartisan Budget Act of 2018 and set forth in in Final rule 
(CMS-4185-F, RIN 0938-AT59) for CY2020 and 2021. The integration 
requirements improve care coordination, quality of care, and 
beneficiary satisfaction while reducing administrative burden. Form 
Number: CMS-R-267 (OMB control number: 0938-0753); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 6,727,508; Total Annual Responses: 6,750,814; Total Annual 
Hours: 1,848,180. (For policy questions regarding this collection 
contact Marna Metcalf Akbar at 410-786-8251.)

    Dated: May 29, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-12002 Filed 6-3-20; 8:45 am]
 BILLING CODE 4120-01-P