[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63655-63657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10260, CMS-R-297/CMS-L564, CMS-4040, CMS-10718 
and CMS-10146]


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 January 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 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-10260 Medicare Advantage and Prescription Drug Program: Final 
Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3)
CMS-R-297/CMS-L564 Request for Employment Information
CMS-4040 Request for Enrollment in Supplementary Medical Insurance 
(SMI) and Supporting Regulations in 42 CFR 407.10, 407.11 and 
408.40(a)(2)
CMS-10718 Model Medicare Advantage and Medicare Prescription Drug Plan 
Individual Enrollment Request Form
CMS-10146 Notice of Denial of Medicare Prescription Drug Coverage

    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 with change of 
a currently approved collection; Title of Information Collection: 
Medicare Advantage and Prescription Drug Program: Final Marketing 
Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3); Use: Pursuant to 
disclosure requirements set out in sections 1851(d)(2)(A) and 1860D-
1(c) of the Social Security Act (the Act), and cited in Sec. Sec.  
422.111(a)(3) and 423.128(a)(3), Medicare Advantage (MA) organizations 
and Part D sponsors must provide notice to plan members of impending 
changes to plan benefits, premiums and cost sharing in the coming year. 
To this effect, members will be in the best position to make an 
informed choice on continued enrollment or disenrollment from that plan 
at least 15 days before the Annual Election Period (AEP) using the 
Annual Notice of Change (ANOC) and before the first day of the AEP for 
the Evidence of Coverage (EOC). MA organizations and Part D sponsors 
must notify plan members of the coming year changes using the 
standardized ANOC. Plans must disseminate the EOC at the time of 
enrollment and at least annually thereafter.
    CMS requires MA organizations and Part D sponsors to use the 
standardized documents being submitted for OMB approval to satisfy 
disclosure requirements mandated by section 1851(d)(3)(A) of the Act 
and Sec.  422.111 for MA organizations and section 1860D-1(c) of the 
Act and Sec.  423.128(a)(3) for Part D sponsors.
    Sections 1851(h)(1) and (2) of the Act require MA organizations and 
Part D sponsors to obtain CMS approval of marketing materials to ensure 
that MA organizations and Part D sponsors disclose correct information 
to current and potential enrollees. CMS collects and retains the MA 
organization and Part D plan marketing materials via the Health Plan 
Management System

[[Page 63656]]

(HPMS). MA organizations and Part D plans submit marketing materials to 
the CMS marketing material review process using HPMS. Both current and 
potential enrollees can review other marketing materials to find plan 
benefits, premiums, and cost sharing for the coming year (after October 
1) and the current year to be in a better position to make.
    MA organizations and Part D sponsors use the information discussed 
in the Medicare Communication and Marketing Guidelines (MCMG) to comply 
with the requirements to seek CMS approval on marketing materials under 
MA and Part D law and regulations, as described above. CMS requires MA 
organizations and Part D sponsors to obtain CMS approval of marketing 
materials to ensure that MA organizations and Part D sponsors disclose 
correct information to current and potential enrollees. Both current 
and potential enrollees can review other marketing materials to find 
plan benefits, premiums, and cost sharing for the coming year (after 
October 1) and the current year to be in a better position to make 
informed and educated plan selections. Form Number: CMS-10260 (OMB 
control number: 0938-1051); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 795; Total Annual 
Responses: 47,962; Total Annual Hours: 33,124. (For policy questions 
regarding this collection contact Timothy Roe at (410) 786-2006.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Request for Employment Information; Use: The form CMS-L564, also 
referred to as CMS-R-297, is used, in conjunction with form CMS-40-B, 
Application for Supplementary Medical Insurance, during an individual's 
special enrollment period (SEP). Completed by an employer, the CMS-L564 
provides proof of an applicant's employer group health coverage. The 
Social Security Administration (SSA) uses it to obtain information from 
employers regarding whether a Medicare beneficiary's coverage under a 
group health plan is based on current employment status. This form is 
available in both English and Spanish.
    Section 1837(i) of the Social Security Act (the Act) provides a SEP 
for individuals who delay enrolling in Medicare Part B because they are 
covered by a group health plan based on their own or a spouse's current 
employment status. Disabled individuals with Medicare may also delay 
enrollment because they have large group health plan coverage based on 
their own or a family member's current employment status. When these 
individuals apply for Medicare Part B, they must provide proof that the 
group health plan coverage is (or was) based on current employment 
status. Form CMS L564 provides this proof so that SSA can determine 
eligibility for the SEP. Individuals eligible for the SEP can enroll in 
Part B without incurring a late enrollment penalty. Individuals may 
also use this form to prove that their group health plan coverage is 
based on current employment status and to have the assessed Medicare 
late enrollment penalty reduced.
    The form is available online via Medicare.gov and CMS.gov for 
individuals who are requesting the SEP to obtain and submit to their 
employer for completion. The employer must complete and sign the form, 
and submit it to the individual to accompany their enrollment or late 
enrollment penalty reduction request. The information on the completed 
form is reviewed manually by SSA. Thus, the collection of this 
information does not involve the use of information technology. Form 
Number: CMS-R-297/CMS-L564 (OMB control number: 0938-0787); Frequency: 
Yearly; Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 15,000; Total Annual Responses: 15,000; Total Annual 
Hours: 1,250. (For policy questions regarding this collection contact 
Carla D. Patterson, at (410) 786-1000.)
    3. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Request for Enrollment in Supplementary Medical Insurance (SMI) and 
Supporting Regulations in 42 CFR 407.10, 407.11 and 408.40(a)(2); Use: 
Section 1836 of the Social Security Act, and CMS regulations at 42 CFR 
407.10, provide the eligibility requirements for enrollment in Part B 
for individuals age 65 and older who are not entitled to premium-free 
Part A. The individual must be a resident of the United States, and 
either a U.S. Citizen or an alien lawfully admitted for permanent 
residence that has lived in the US continually for 5 years.
    CMS regulations 42 CFR 407.11 lists the CMS-4040 as the application 
to be used by individuals who are not eligible for monthly Social 
Security/Railroad Retirement Board benefits or free Part A.
    The CMS-4040 solicits the information that is used to determine 
entitlement for individuals who meet the requirements in section 1836 
as well as the entitlement of the applicant or their spouses to an 
annuity paid by OPM for premium deduction purposes. The application 
follows the application questions and requirements used by SSA. This is 
done not only for consistency purposes but to comply with other Title 
II and Title XVIII requirements because eligibility to Title II 
benefits and free Part A under Title XVIII must be ruled out in order 
to qualify for enrollment in Part B only. Form Number: CMS-4040 (OMB 
control number: 0938-0245); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 29,663; Total 
Annual Responses: 29,663; Total Annual Hours: 7,416 hours. (For policy 
questions regarding this collection contact Carla D. Patterson, at 
(410) 786-1000.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Model 
Medicare Advantage and Medicare Prescription Drug Plan Individual 
Enrollment Request Form; Use: This information collection is necessary 
for the Medicare beneficiary (or their legal representative), to enroll 
in an MA or PDP plan, even if switching plans within the same MA or PDP 
organization. To consider an election complete, the individual must:
     Complete an enrollment request;
     Provide required information to the MA or PDP organization 
within the required time frames;
     Submit the completed request to the MA or PDP organization 
during a valid enrollment period.
    MA and PDP organizations, applicants to MA and PDP organizations, 
and the CMS will use the information collected to comply with the 
eligibility and enrollment requirements for Medicare Part C and Part D 
plans.
    Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) enacted August 5, 1997, established Part C of the Medicare program, 
known as the Medicare + Choice program, (now referred to as Medicare 
Advantage (MA)). As required by 42 CFR 422.50(a)(5), an MA-eligible 
individual who meets the eligibility requirements for enrollment into 
an MA or MAPD plan may enroll during the enrollment periods specified 
in Sec.  422.62, by completing an enrollment form with the MA 
organization or enrolling through other mechanisms that the Centers for 
Medicare & Medicaid Services (CMS) determines are appropriate.
    Section 101 of Title I of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) 
enacted December 8, 2003, established Part D of the Medicare

[[Page 63657]]

program, known as the Voluntary Prescription Drug Benefit Program. As 
required by 42 CFR 423.32(a) and (b), a Part D-eligible individual who 
wishes to enroll in a Medicare prescription drug plan (PDP) may enroll 
during the enrollment periods specified in Sec.  423.38, by completing 
an enrollment form with the PDP, or enrolling through other mechanisms 
CMS determines are appropriate. Form Number: CMS-10718 (OMB control 
number: 0938-New); Frequency: Yearly; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 14,749,256; Total Annual 
Responses: 14,749,256; Total Annual Hours: 10,324,481. (For policy 
questions regarding this collection contact Deme Umo at (410) 786-
8854.)
    5. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Notice of Denial of Medicare Prescription Drug Coverage; Use: The 
purpose of this notice is to provide information to enrollees when 
prescription drug coverage has been denied, in whole or in part, by 
their Part D plans. The notice must be readable, understandable, and 
state the specific reasons for the denial. The notice must also remind 
enrollees about their rights and protections related to requests for 
prescription drug coverage and include an explanation of both the 
standard and expedited redetermination processes and the rest of the 
appeal process.
    CMS requests approval of changes to a currently approved collection 
under section 1860D-4(g)(1) of the Social Security Act which requires 
Part D plan sponsors that deny prescription drug coverage to provide a 
written notice of the denial to the enrollee. The written notice must 
include a statement, in understandable language, of the reasons for the 
denial and a description of the appeals process.
    Medicare beneficiaries who are enrolled in a Part D plan will be 
informed of adverse decisions related to their prescription drug 
coverage and their right to appeal these decisions. The notice provides 
all ways that the beneficiary can file an appeal under one section. The 
Part D instructions have also been revised to include a paragraph 
informing providers that in the case that a request for a coverage 
determination is denied under Part B due to step therapy requirements, 
a different notice should be given.
    This denial notice is primarily issued to Part D plan enrollees 
(Medicare beneficiaries) and is most commonly sent to enrollees by 
mail. Relying on electronic transmission of this notice to 
beneficiaries is impractical. Plans are required by regulation to 
maintain a website by which beneficiaries can request an appeal. In 
this version of the notice, website information is more prominently 
displayed. Form Number: CMS-10146 (OMB control number: 0938-0976); 
Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 525; Total Annual Responses: 
2,887,866; Total Annual Hours: 721,967. (For policy questions regarding 
this collection contact Sara Klotz at (410) 786-1984.)

    Dated: November 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-24930 Filed 11-15-19; 8:45 am]
 BILLING CODE 4120-01-P