[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Rules and Regulations]
[Pages 21949-21950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-1687-RCN]
RIN 0938-AT21


Medicare Program; Durable Medical Equipment Fee Schedule 
Adjustments To Resume the Transitional 50/50 Blended Rates To Provide 
Relief in Rural Areas and Non-Contiguous Areas; Extension of Timeline 
for Final Rule Publication

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Continuation of effectiveness and extension of timeline for 
publication of the final rule.

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SUMMARY: This document announces the continuation of effectiveness of a 
Medicare interim final rule and the extension of the timeline for 
publication of the final rule. Section 1871(a)(3)(B) of the Social 
Security Act (the Act) specifies that a Medicare final rule must be 
published no later than 3 years after the publication date of the 
proposed or interim final rule, except under exceptional circumstances. 
In accordance with sections 1871(a)(3)(B) and 1871(a)(3)(C) of the Act, 
we are providing a notification of continuation for a Medicare interim 
final rule, announcing the different timeline on which we intend to 
publish the final rule, and explaining why we were unable to publish 
the final rule on the regular, required 3-year timeline.

DATES: As of April 23, 2021, the Medicare provisions adopted in the 
interim final rule published on May 11, 2018 (83 FR 21912) continue in 
effect and the regular timeline for publication of the final rule is 
extended for an additional year, until May 11, 2022.

FOR FURTHER INFORMATION CONTACT: Alexander Ullman, (410) 786-9671 or 
[email protected].

SUPPLEMENTARY INFORMATION: In the May 11, 2018 Federal Register (83 FR 
21912), we published an interim final rule with comment period (IFC) 
titled ``Medicare Program; Durable Medical Equipment Fee Schedule 
Adjustments to Resume the Transitional 50/50 Blended Rates to Provide 
Relief in Rural Areas and Non-Contiguous Areas''. The May 2018 IFC made 
technical amendments to the regulation to reflect the extension of the 
transition period from June 30, 2016 to December 31, 2016 that was 
mandated by the 21st Century Cures Act for phasing in fee schedule 
adjustments for certain durable medical equipment (DME) and enteral 
nutrition furnished in areas not subject to the Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive 
Bidding Program (CBP) (83 FR 21915). In addition, in the May 2018 IFC, 
CMS--(1) amended 42 CFR 414.210(g) to resume the transition period's 
blended fee schedule rates for items furnished in rural areas and non-
contiguous areas (Alaska, Hawaii, and United States territories) not 
subject to the CBP from June 1, 2018 through December 31, 2018 (83 FR 
21915); (2) made technical amendments to existing DMEPOS regulations to 
reflect the exclusion of infusion drugs used with DME from the DMEPOS 
CBP (83 FR 21919); and (3) stated that the fee schedule amounts for 
wheelchair accessories and back and seat cushions used in conjunction 
with group 3 power wheelchairs would continue to be based on the 
unadjusted fee schedule amounts updated by the covered item update 
specified in section 1834(a)(14) of the Act (83 FR 21919). We stated 
that the fee schedule amounts for all other accessories used with 
different types of base equipment would continue to be calculated in 
accordance with the adjustment methodology set forth in Sec.  
414.210(g)(5) of our regulations (83 FR 21919).
    Section 1871(a)(3)(B) of the Act requires CMS to publish a Medicare 
final rule no later than 3 years after the publication of a proposed or 
interim final rule, except under exceptional circumstances. In such 
circumstances, section 1871(a)(3)(B) of the Act allows the Secretary to 
vary the final regulation publication timeline if the Secretary 
provides public notice of the different timeline on which it intends to 
publish the final regulation, and that notice includes a brief 
explanation of the justification for the variation. The notice must be 
published by no later than the timeline previously established with 
respect to the final rule publication date.
    The May 2018 IFC was published on May 11, 2018. Therefore, in 
accordance with section 1871(a)(3)(B) of the Act, we must finalize the 
May 2018 IFC by May 11, 2021, except under exceptional

[[Page 21950]]

circumstances. We will not be able to finalize the May 2018 IFC within 
the required 3-year timeline for publication (by May 11, 2021) for the 
following reasons:
    In the November 4, 2020 Federal Register (85 FR 70358), we 
published a proposed rule titled ``Medicare Program; Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues 
and Level II of the Healthcare Common Procedure Coding System (HCPCS)'' 
(hereinafter DMEPOS and HCPCS proposed rule). In the DMEPOS and HCPCS 
proposed rule (85 70373), we stated that we solicited comments on the 
2018 Interim Final Rule, but because we have not yet responded to the 
comments we received, we are signaling our intent to do so in the final 
rule.
    On January 20, 2021, the Assistant to the President and Chief of 
Staff issued a memorandum concerning ``Regulatory Freeze Pending 
Review'' (``Regulatory Freeze memorandum'').\1\ The Office of 
Management and Budget (OMB) issued Memorandum M-21-14 on January 20, 
2021, providing guidance on implementing the Regulatory Freeze 
memorandum.\2\ The Regulatory Freeze memorandum seeks to ensure that 
the President's appointees or designees have the opportunity to review 
any new or pending rules. Paragraph 1 of the Regulatory Freeze 
memorandum directs agencies, subject to any exceptions the Director of 
the OMB allows for emergency situations or other urgent circumstances 
relating to health, safety, environmental, financial, or national 
security matters, or otherwise, to propose or issue no rule in any 
manner--including by sending a rule to the Office of the Federal 
Register--until a department or agency head appointed or designated by 
the President after noon on January 20, 2021, reviews and approves the 
rule. Additionally, paragraph 3 of the Regulatory Freeze memorandum 
describes the agency option to temporarily postpone agency rules to 
permit review by an agency head appointed or designated by the 
President after noon on January 20, 2021.
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    \1\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/regulatory-freeze-pending-review/ (86 FR 7424, 
January 28, 2021).
    \2\ https://www.whitehouse.gov/wp-content/uploads/2021/01/M-21-14-Regulatory-Review.pdf.
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    In light of our efforts to comply with the Regulatory Freeze 
memorandum, and to allow policy officials in the new administration the 
opportunity to review the DMEPOS and HCPCS proposed rule and May 2018 
IFC, we do not believe we will have sufficient time to finalize the 
IFC, and relatedly the DMEPOS and HCPCS proposed rule, by the May 11, 
2021 deadline. As a result of these exceptional circumstances, we are 
issuing this notification of continuation and extending the timeline 
for finalizing the May 2018 IFC by 1 year. This extension will grant 
policy officials the opportunity to review the DMEPOS and HCPCS 
proposed rule and the May 2018 IFC. In accordance with section 
1871(a)(3)(C) of the Act, this notification of continuation also 
ensures that the May 2018 IFC continues in effect beyond May 11, 2021. 
As a result of the publication of this notification of continuation, 
the timeline for publication of the final rule will be treated as 
having been extended until May 11, 2022.

    Dated: April 21, 2021.
Wilma Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2021-08661 Filed 4-23-21; 8:45 am]
BILLING CODE 4120-01-P