[Federal Register Volume 85, Number 41 (Monday, March 2, 2020)]
[Notices]
[Pages 12303-12305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10146, CMS-10062, CMS-10242 and CMS-685]


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 April 1, 2020.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax

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Number: (202) 395-5806 OR, Email: [email protected].
    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.
    1. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    2. 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: 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.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Collection of Diagnostic Data in the Abbreviated RAPS Format from 
Medicare Advantage Organizations for Risk Adjusted Payments; Use: The 
1997 BBA and later legislation required CMS to adjust per-beneficiary 
payments with a risk adjustment methodology using diagnoses to measure 
relative risk due to health status instead of just demographic 
characteristics such as age, sex, and Medicaid eligibility. The purpose 
of risk adjustment is to pay plan sponsors accurately based on the 
health status and diagnoses of their Medicare enrollees. Risk 
adjustment using diagnoses provides more accurate payments for Medicare 
Advantage Organizations (MAO), with higher payments for enrollees at 
risk for being sicker, and lower payments for enrollees predicted to be 
healthier.
    The BBA constituted the first legislative mandate for health status 
risk adjustment. Section 1853 (a)(3) of the Social Security Act as 
enacted by Section 4001 of Subtitle A of the BBA required the Secretary 
to implement a risk adjustment methodology that accounted for 
variations in per capita costs based on health status and other 
demographic factors for payment to Medicare+Choice (now MA) 
organizations. The new methodology was to be effective no later than 
January 1, 2000. The BBA also required that M+C organizations submit 
data for use in developing risk adjusted payments.
    Risk adjustment allows CMS to pay plans for the health risk of the 
beneficiaries they enroll, instead of paying an identical an average 
amount for each enrollee Medicare beneficiaries. By risk adjusting plan 
payments, CMS is able to make appropriate and accurate payments for 
enrollees with differences in expected costs. Risk adjustment is used 
to adjust bidding and payment based on the health status and 
demographic characteristics of an enrollee. Risk scores measure 
individual beneficiaries' relative risk and the risk scores are used to 
adjust payments for each beneficiary's expected expenditures. By risk 
adjusting plan bids, CMS is able to also use standardized bids as base 
payments to plans.
    CMS' fundamental goal for the abbreviate format RAPS data is to 
require collection of the minimum data necessary for accurate risk-
adjusted payment. We believe that diagnostic data provide the most 
reliable approach to measuring health status, as required by statute. 
In the absence of these data, we would not be able to accurately 
determine the beneficiary's health (risk) status. Form Number: CMS-
10062 (OMB control number: 0938-0878); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 
761; Total Annual Responses: 46,610,448; Total Annual Hours: 33,484. 
(For policy questions regarding this collection contact Michael P 
Massimini at 410-786-1566.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Emergency and 
Non-Emergency Ambulance Transports and Beneficiary Signature 
Requirements; Use: The statutory authority requiring a beneficiary's 
signature on a claim submitted by a provider is located in section 
1835(a) and in 1814(a) of the Social Security Act (the Act), for Part B 
and Part A services, respectively. The authority requiring a 
beneficiary's signature for supplier claims is implicit in sections 
1842(b)(3)(B) (ii) and in 1848(g)(4) of the

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Act. Federal regulations at 42 CFR 424.32(a)(3) state that all claims 
must be signed by the beneficiary or on behalf of the Beneficiary (in 
accordance with 424.36). Section 424.36(a) states that the 
beneficiary's signature is required on a claim unless the beneficiary 
has died or the provisions of 424.36(b), (c), or (d) apply. For 
emergency and nonemergency ambulance transport services, where the 
beneficiary is physically or mentally incapable of signing the claim 
(and the beneficiary's authorized representative is unavailable or 
unwilling to sign the claim), that it is impractical and infeasible to 
require an ambulance provider or supplier to later locate the 
beneficiary or the person authorized to sign on behalf of the 
beneficiary, before submitting the claim to Medicare for payment. 
Therefore, an exception was created to the beneficiary signature 
requirement with respect to emergency and nonemergency ambulance 
transport services, where the beneficiary is physically or mentally 
incapable of signing the claim, and if certain documentation 
requirements are met. Thus, we added subsection (6) to paragraph (b) of 
42 CFR 424.36. The information required in this ICR is needed to help 
ensure that services were in fact rendered and were rendered as billed. 
Form Number: CMS-10242(OMB control number: 0938-1049); Frequency: 
Yearly; Affected Public: Private Sector; Business or other for-profits, 
Not-for-profit Institutions; Number of Respondents: 10,229; Total 
Annual Responses: 13,318,440; Total Annual Hours: 1,110,757. (For 
policy questions regarding this collection contact Martha Kuespert at 
(410) 786-4605.)
    4. Type of Information Collection Request: Revision of a previously 
approved collection; Title of Information Collection: End Stage Renal 
Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting 
Regulations; Use: Section 1881(c) of the Social Security Act 
establishes End Stage Renal Disease (ESRD) Network contracts. The 
regulations found at 42 CFR 405.2110 and 405.2112 designated 18 ESRD 
Networks which are funded by renewable contracts. These contracts are 
on 3-year cycles. To better administer the program, CMS is requiring 
contractors to submit semi-annual cost reports. The purpose of the cost 
reports is to enable the ESRD Networks to report costs in a 
standardized manner. This will allow CMS to review, compare and project 
ESRD Network costs during the life of the contract. Form Number: CMS-
685 (OMB Control Number: 0938-0657); Frequency: Reporting--Semi-
annually; Affected Public: Not-for-profit institutions; Number of 
Respondents: 18; Total Annual Responses: 36; Total Annual Hours: 108. 
(For policy questions regarding this collection contact Benjamin 
Bernstein at 410-786-6570).

    Dated: February 26, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-04242 Filed 2-28-20; 8:45 am]
 BILLING CODE 4120-01-P