78770 Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Rules and Regulations 

1But see Azar v. Allina Health Servs., 139 S. Ct. 

1804 (2019). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–5533–N2] 

Medicare Program; Alternative 

Payment Model (APM) Incentive 

Payment Advisory for Clinicians— 

Request for Current Billing Information 

for Qualifying APM Participants— 

Update 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Payment advisory. 

SUMMARY: This advisory is to update the 

submission date listed in the previous 

Federal Register document published 

on September 17, 2020, titled ‘‘Medicare 

Program; Alternative Payment Model 

(APM) Incentive Payment Advisory for 

Clinicians—Request for Current Billing 

Information for Qualifying APM 

Participants’’ that provides information 

to certain clinicians who are Qualifying 

APM participants (QPs) and eligible to 

receive an Alternative Payment Model 

(APM) Incentive Payment that CMS 

does not have the current billing 

information needed to disburse the 

payment. This update allows these 

clinicians to provide information to 

CMS regarding their billing information 

by December 13, 2020 in order to 

receive this payment. 

DATES: December 7, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Tanya Dorm, (410) 786–2216. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare Quality Payment 

Program, an eligible clinician who 

participates in an Advanced Alternative 

Payment Model (APM) and meets the 

applicable payment amount or patient 

count thresholds for a performance year 

is a Qualifying APM Participant (QP) for 

that year. An eligible clinician who is a 

QP for a year based on their 

performance in a QP Performance 

Period earns a 5 percent lump sum APM 

Incentive Payment that is paid in a 

payment year that occurs 2 years after 

the QP Performance Period. The amount 

of the APM Incentive Payment is equal 

to 5 percent of the estimated aggregate 

payments for covered professional 

services furnished by the QP during the 

calendar year immediately preceding 

the payment year. 

II. Provisions of the Advisory 

The Centers for Medicare & Medicaid 

Services (CMS) has identified those 

eligible clinicians who earned an APM 

Incentive Payment in CY 2020 based on 

their CY 2018 QP status. 

When CMS disbursed the CY 2020 

APM Incentive Payments, CMS was 

unable to verify current Medicare billing 

information for some QPs and was 

therefore unable to issue payment. In 

order to successfully disburse the APM 

Incentive Payment, CMS is requesting 

assistance in identifying current 

Medicare billing information for these 

QPs. 

CMS has compiled a list of QPs we 

have identified as having unverified 

billing information. These QPs, and any 

others who anticipated receiving an 

APM Incentive Payment but have not, 

should follow the instructions to 

provide CMS with updated billing 

information at the following web 

address: https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/ 

1112/2020%20APM%20

Incentive%20Payment%20Notice.pdf. 

On September 17, 2020, we published 

the Medicare Program; Alternative 

Payment Model (APM) Incentive 

Payment Advisory for Clinicians— 

Request for Current Billing Information 

for Qualifying APM Participants (85 FR 

57980), where we announced that 

submissions would need to be received 

no later than November 13, 2020. In this 

updated advisory we are extending this 

deadline, and submissions would need 

to be received no later than December 

13, 2020. 

If you have any questions concerning 

submission of information through the 

website, please contact the QPP Help 

Desk at 1–866–288–8292. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Seema Verma, having reviewed and 

approved this document, authorizes 

Lynette Wilson, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Dated: December 1, 2020. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2020–26776 Filed 12–4–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 1 

RIN 0991–AC17 

Department of Health and Human 

Services Good Guidance Practices 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Final rule. 

SUMMARY: The Department of Health and 

Human Services finalizes its proposed 

regulations governing the agency’s 

release and maintenance of guidance 

documents. These regulations will help 

to ensure that the public receives 

appropriate notice of new guidance and 

that the Department’s guidance does not 

impose obligations on regulated parties 

that are not already reflected in duly 

enacted statutes or regulations lawfully 

promulgated under them. 

DATES: This final rule is effective 

January 6, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Brenna Jenny, Department of Health and 

Human Services, 200 Independence, 

Avenue SW, Room 713F, Washington, 

DC 20201. Email: Good.Guidance@

hhs.gov. Telephone: (202) 690–7741. 

SUPPLEMENTARY INFORMATION: 

I. Statutory and Regulatory Background 

Subject to certain exceptions, the 

Administrative Procedure Act (‘‘APA’’), 

5 U.S.C. 551 et seq., mandates that rules 

imposing new obligations on regulated 

parties must go through notice-andcomment rulemaking. See, e.g., Chrysler 

Corp. v. Brown, 441 U.S. 281, 302 

(1979). This is true regardless of 

whether agencies frame these rules as 

sub-regulatory guidance. See, e.g., Iowa 

League of Cities v. EPA, 711 F.3d 844, 

875 (8th Cir. 2013); Gen. Elec. Co. v. 

EPA, 290 F.3d 377, 385 (D.C. Cir. 2002). 

The APA’s procedural requirements 

sound in notions of good governance. 

See, e.g., Smiley v. Citibank (S.D.), N.A., 

517 U.S. 735, 741 (1996). Agencies can 

generally issue interpretive rules and 

statements of policy without conducting 

notice-and-comment rulemaking,1

although such sub-regulatory guidance 

lacks the force and effect of law, and 

cannot bind regulated parties. See, e.g., 

Shalala v. Guernsey Mem’l Hosp., 514 

U.S. 87, 99 (1995). 

To promote the appropriate issuance 

and use of guidance documents, and 

consistent with the requirements of 

Executive Order 13891, ‘‘Promoting the 


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