Transition 2020-2021

Here’s what this page has so far:

State insurance commissioners’ recommendations for Biden Administration, December 23, 2020

“Ripe for Decision Between Now and January 20, 2021”

Congressional Review Act materials

A list, with links, of regulations that might merit revising.

A list, with links, of policies that are not in regulations but might merit revising.

A note about how much time it might take the Biden Administration to revoke, rescind, or terminate Trump Administration waivers.

A list, with links, of recent Trump Administration HHS policies and proposed regulations on the regulatory process.

A list, with links, of Trump Administration amendments to Obama Administration regulations (Title 45, Parts 92 and 144-159).

A list, with links, of Trump Administration amendments to Medicaid regulations (Title 42, Parts 430 to 457).

Materials on the 2016-2017 transition, including the President’s executive order against the ACA, a memo on staying Obama Administration regulations to the extent possible, and [two] transition case studies, so to speak: on 1557, and on cost-sharing reduction payments.

[Five] U.S. Supreme Court cases on agencies’ reversing position.

 

Presidential Transition Guide, April 2020

Presidential-Transition-Guide-2020

 

H.R. 1425, the Patient Protection and Affordable Care Enhancement Act, as it passed the House, June 2020

BILLS-116hr1425pcs

 

State insurance commissioners’ recommendations for the Biden Administration, December 23, 2020

http://www.insurance.ca.gov/0400-news/0100-press-releases/2020/release138-2020.cfm

nr138LetterToPres-ElectBiden12232020

 

Marcia Coyle, At Supreme Court, Trump’s Solicitor Flipped Positions. Biden’s Team Is Sure to Follow Suit, National Law Journal, Nov. 18, 2020

Coyle, At Supreme Court, Trump’s Solicitor Flipped Positions. Biden’s Team is Sure to Follow Suit.

 

Biden Administration transition news conference on regulations freeze, Dec. 30, 2020

https://www.cbsnews.com/news/joe-biden-halt-trump-midnight-regulations-inauguration-day/

 

NPR story on health care transition, Jan. 8, 2021

https://www.npr.org/sections/health-shots/2021/01/08/954696566/when-biden-takes-office-undoing-trumps-health-policies-wont-be-easy

 

Drew Altman column, Jan. 11, 2021

Joe Biden’s New Health Care Agenda (and CMS’s Big Role In It)

 

American Rescue Plan, released January 14, 2021

COVID_Relief-Package-Fact-Sheet

At pages 15-16:

Preserving and expanding health coverage. Roughly two to three million people lost employer sponsored health insurance between March and September, and even families who have maintained coverage may struggle to pay premiums and afford care.  Further, going into this crisis, 30 million people were without coverage, limiting their access to the health care system in the middle of a pandemic. To ensure access to health coverage, President-elect Biden is calling on Congress to subsidize continuation health coverage (COBRA) through the end of September. He is also asking Congress to expand and increase the value of the Premium Tax Credit to lower or eliminate health insurance premiums and ensure enrollees – including those who never had coverage through their jobs – will not pay more than 8.5 percent of their income for coverage.  Together, these policies would reduce premiums for more than ten million people and reduce the ranks of the uninsured by millions more.

New York Times story, January 16, 2021:

 

 

 

Ripe for Decision Between Now and January 20, 2021

ripe-for-decision-between-now-1-19-and-january-20

 

Regulatory Freeze Pending Review, January 20, 2021

Regulatory Freeze Pending Review

 

Congressional Review Act, 5 U.S.C. secs. 801-808

5 usc 802

Congressional Review Act frequently asked questions (Congressional Research Service, updated January 14, 2020)

R43992

Daniel Perez, CRA Update, December 23, 2020

GW Reg Studies – CRA Update – DPerez

 

 

Pending regulatory changes

Proposed HIPAA revisions proposed rule and fact sheet, December 10, 2020

hhs-ocr-hipaa-nprm

HIPAA privacy rule proposed modifications 12 10 20

 

Proposed IRS regulations on, among other things, contributions to health care sharing ministries, 85 Fed. Reg. 35,398 (June 10, 2020)

2020-12213

Health Affairs commentary

https://www.healthaffairs.org/do/10.1377/hblog20200611.714521/full/

Christianity Today commentary (on Aliera/Trinity)
 
 

Medicaid Program; Medicaid Fiscal Accountability Regulation, 84 Fed. Reg. 63,722 (Nov. 18, 2019), withdrawn Jan. 7, 2021 —

2019-24763-1

 

Formerly pending regulatory changes

Confidentiality of Substance Use Disorder Patient Records, 85 Fed. Reg. 80,626 (Dec. 14, 2020)

2020-25810

Grandfathered group health plans final rule, 85 Fed. Reg. 81,097 (Dec. 15, 2020)

2020-27498

Equal Participation of Faith-Based Organizations in the Federal Agencies’ Programs and Activities, 85 Fed. Reg. 82,037 (Dec. 17, 2020), with fact sheet

2020-27084

https://www.hhs.gov/about/news/2020/12/14/hhs-announces-joint-final-rule-regarding-equal-treatment-faith-based-organizations.html

 

U.S. Supreme Court case on ripeness, Trump v. New York, No. 20-366 (Dec. 18, 2020)

20-366_7647

 

REGULATIONS THAT MIGHT MERIT REVISING

 

Association health plans

Association health plans proposed regulations, 83 Fed. Reg. 614 (Jan. 5, 2018)

Association health plans, final rule, 83 Fed. Reg. 28912 (June 21, 2018)

For current litigation, see https://affordablecareactlitigation.com/whittling-away/

 

 

1557

Proposed rule: HHS, Nondiscrimination in Health and Health Education Programs or Activities

Federal Register version, 84 Fed. Reg. 27846 (June 14, 2019)

2019-11512

Final rule: HHS, Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority

Federal Register version, 85 Fed.Reg. 37160 (June 19, 2020)

2020-11758

45 C.F.R. Part 92

45 CFR Part 92 current

Obama Administration version: Nondiscrimination in Health Programs and Activities; Final Rule

81 Fed. Reg. 31376 (May 18, 2016)

2016-11458

45 C.F.R. Part 92, with regulations probably vacated in Franciscan Alliance in red

1557 regs 2016 (as vacated by Judge O’Connor)

For current litigation, see https://affordablecareactlitigation.com/aca-enforcement-directly-and-1557/

 

Public charge

Field Guidance on Deportability and Inadmissibility on Public Charge Grounds, 64 Fed. Reg. 28, 689 (March 26, 1999)

99-13202

Proposed regulations, 83 Fed.Reg. 51114 (Oct. 10, 2018)

2018-21106

Final regulations, 84 Fed.Reg. 41292 (Aug. 14, 2019)

2019-17142

For current litigation, see https://affordablecareactlitigation.com/public-charge-disability-claims

 

Short-term, limited-duration insurance

Proposed rule: 83 Fed. Reg. 7437 (Feb. 21, 2018)

2018-03208-fr

Final rule: 83 Fed. Reg. 38,212 (Aug. 3, 2018)

2018-16568

Obama Administration regulation: DOL/HHS, “Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance,” 81 Fed. Reg. 75316 (October 31, 2016)

For current litigation, see https://affordablecareactlitigation.com/whittling-away/

 

Statutory conscience protections

Proposed rule: HHS, “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” 83 Fed. Reg. 3880 (Jan. 26, 2018)

2018-01226

Final rule: HHS, “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” 84 Fed. Reg. 23,170 (May 21, 2019)

Federal Register version, 84 Fed. Reg. 23,170 (May 21, 2019)

2019-09667

For current litigation, see https://affordablecareactlitigation.com/statutory-conscience-rights

 

1303

Proposed rule: Patient Protection and Affordable Care Act; Exchange Program Integrity, 83 Fed. Reg. 56,015 (Nov. 9, 2018)

2018-24504

Final rule: Patient Protection and Affordable Care Act; Exchange Program Integrity, 84 Fed. Reg. 71,674 (Dec. 27, 2018)

2019-27713

For current litigation, see https://affordablecareactlitigation.com/religious-and-moral/ (near the bottom of the page)

 

Title X

Proposed rule: Compliance With Statutory Program Integrity Requirements, 83 Fed. Reg. 25,502 (June 1, 2018)

2018-11673

Final rule: DHHS, “Compliance With Statutory Program Integrity Requirements,” 84 Fed. Reg. 7714 (March 4, 2019)

2019-03461

For current litigation, see https://affordablecareactlitigation.com/title%20x%20program%20integrity/

 

POLICIES THAT MIGHT MERIT REVISING

 

Health Insurance Coverage Proclamation

Suspension of Entry of Immigrants Who Will Financially Burden the United States Healthcare System, in Order To Protect the Availability of Healthcare Benefits for Americans, 84 Fed. Reg. 53,991 (Oct. 4, 2019)

2019-22225

For current litigation, see https://affordablecareactlitigation.com/public-charge-disability-claims

 

Medicaid 1115 Waivers — Community Engagement

Dear State Medicaid Directors letter, Jan. 11, 2018

For current litigation, see https://affordablecareactlitigation.com/1115-medicaid-waivers-community-engagement/

Revoking or withdrawing an 1115 waiver:

Medicaid Program; Demonstration Proposals Pursuant to Section 1115(a) of the Social Security Act; Policies and Procedures, 59 Fed. Reg. 49,249 (Sept. 27, 1994)

59 Fed Reg Medicaid waiver policies

State Medicaid Director Letter (SMDL) #02–007, May 2002

smd050302

GAO, Recent HHS Approvals of Demonstration Waiver Projects Raise Concerns, 2002

235107

GAO, ‘‘Medicaid Demonstration Waivers: Lack of Opportunity for Public Input during the Federal Approval Process Still a Concern,” 2007

95034

Proposed regulations on the 1115 process, 75 Fed. Reg. 56,946 (Sept. 17, 2010)

2010-23357

Final regulations on the 1115 process, 77 Fed. Reg. 11,678 (Feb. 27, 2012)

2012-4354

42 C.F.R. § 431.420 Monitoring and compliance.

(d)Terminations and suspensions.

(1) The Secretary may suspend or terminate a demonstration in whole or in part, any time before the date of expiration, whenever it determines that the State has materially failed to comply with the terms of the demonstration project.

(2) The Secretary may also withdraw waivers or expenditure authorities based on a finding that the demonstration project is not likely to achieve the statutory purposes.

(3) The terms and conditions for the demonstration will detail any notice and appeal rights for the State for a termination, suspension or withdrawal of waivers or expenditure authorities.

1115 waiver terms and conditions

Here is a standard Medicaid condition (the just-granted Georgia 1115 waiver):

    1. Withdrawal of Waiver or Expenditure Authority. CMS reserves the right to withdraw expenditure authorities and end the demonstration at any time it determines that continuing the expenditure authorities would no longer be in the public interest or promote the objectives of title XIX. CMS must promptly notify the state in writing of the determination and the reasons for the withdrawal, together with the effective date, and afford the state an opportunity to request an administrative hearing to challenge CMS’ determination prior to the effective date. If expenditure authority is withdrawn, FFP is limited to normal closeout costs associated with terminating the expenditure authority, including services, continued benefits as a result of beneficiary appeals, and administrative costs of disenrolling beneficiaries.

 And here is another standard Medicaid condition (one of the Arkansas 1115 waivers):

    1. Withdrawal of Demonstration Authority. CMS reserves the right to amend and withdraw waivers or expenditure authorities at any time it determines that continuing the waivers or expenditure authorities would no longer be in the public interest or promote the objectives of Title XIX, including if federal monitoring of data indicates that the community engagement features of this demonstration may not adequately incentivize beneficiary participation or are unlikely to result in improved health outcomes, or that other demonstration features are not operating as intended. CMS will promptly notify the State in writing of the determination and the reasons for the amendment and withdrawal, together with the effective date, and afford the State an opportunity to request a hearing to challenge CMS’ determination prior to the effective date. If a waiver or expenditure authority is withdrawn or amended, FFP is limited to normal closeout costs associated with terminating the waiver or expenditure authority, including services and administrative costs of disenrolling beneficiaries.
 

But here is Administrator Verma’s proposal to States that they amend waivers to make them harder to revoke:

Administrator Verma’s letter to Vermont, 1/4/21, with proposed amendment language
 
 
And her letter to Alaska about Alaska’s behavioral health waiver letter, agreed to by Alaska, 1/4/21 and 1/8/21
 

And the general template CMS has been using

Withdrawal Terms Letter with Enclosed Agreement (FORMATTED) template (1).._

Representative Pallone’s and Senator Wyden’s letter to CMS, 1/19/21

Pallone Wyden Ltr to CMS 1.19.21 UPDATED

National Health Law Program petition, 1/20/21
 
 

Bagley article in The Atlantic, 1/21/21

Bagley on work requirements

 

Medicaid 1115 Waivers — Block Grants

CMS Healthy Adult Opportunity proposal, January 30, 2020

smd20001

For current controversies, see https://affordablecareactlitigation.com/medicaid-1115-block-grant-waiver

 

Medicaid Freedom of Choice of Provider

Dear State Medicaid Director Letter 16-005, April 19, 2016

SMD16005

Dear State Medicaid Director Letter 18-003, Jan. 19, 2018, rescinding 16-005

smd18003

For current controversies, see, e.g., Planned Parenthood South Atlantic v. Baker, No. 18-2133 (4th Cir., Oct. 29, 2019), 4C PP v Baker opinion

 

1332

HHS 1332 guidance and fact sheet, 83 Fed. Reg. 53575 (Oct. 24, 2018) 2018-23182-1
 
 
Waiver concepts and FAQs, November 29, 2018
 
 
 
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations, November 25, 2020 (see pp. 262-68 and 338-40 of the non Federal Register version for the 1332 proposals)
 
 
Federal Register version, 85 Fed. Reg. 78,572 (December 4, 2020) (see pp. 78,648-78,650 and 78,676-78,677 for the 1332 proposals)
 
 
HHS fact sheet, November 25, 2020 (see page 6 for the 1332 proposals)
 

Obama Administration: CMS, “Waivers for State Innovation” guidance, 80 Fed. Reg. 78131 (Dec. 16, 2015)

For current controversies, see https://affordablecareactlitigation.com/1332-2/

Revoking or withdrawing a 1332 waiver

45 C.F.R. § 155.1320 Monitoring and compliance.

(d) Terminations and suspensions. The Secretary and the Secretary of the Treasury, as applicable, reserve the right to suspend or terminate a section 1332 waiver in whole or in part, at any time before the date of expiration, whenever the Secretary or the Secretary of the Treasury, as applicable, determines that a State has materially failed to comply with the terms of a section 1332 waiver.

1332 waiver terms and conditions

    1. The Departments’ Right to Amend, Suspend, or Terminate. Under 31 C.F.R. § 33.120(d) and 45 C.F.R. § 155.1320(d), the Departments reserve the right to amend, suspend, or terminate, the waiver (in whole or in part) at any time before the date of expiration, only if the Departments determine that the state has materially failed to comply with these STCs, or if the state fails to meet the specific statutory requirements or “guardrails” related to coverage, affordability, comprehensiveness, or deficit neutrality.

(a) The Departments will promptly notify the state in writing of the determination and the reasons for the amendment, suspension, or termination, together with the effective date.

(b) The state will have 90 days from receipt of the Departments’ notification to respond and, if applicable, provide a corrective action plan to bring the waiver into compliance with the STCs. The Departments must afford the state an opportunity to be heard and to challenge the Departments’ determination prior to the effective date of the applicable amendment, suspension or termination.

(c) In the event that all of or a portion of the waiver is suspended or terminated by the Departments, federal funding available after the effective date of the suspension, or termination will be limited to normal closeout costs associated with an orderly suspension or termination including service costs during any approved transition period and administrative costs of transitioning participants, as described in 31 C.F.R. § 33.120(e) and 45 C.F.R. § 155.1320(e).

(d) Unused pass-through funding will be recovered. The state will comply with all necessary steps to facilitate the recovery within a prompt timeframe.

(e) Transition period. To avoid disruption and provide a reasonable transition period, the Departments will take all reasonable measures to align any termination or suspension of the waiver (in whole or in part) with the beginning of the following plan year and will take steps to mitigate any disruption to enrollees, the state, and other relevant stakeholders.

 

How much time might it take the Biden Administration to rescind or terminate a waiver?

Depends on what kind of waiver it is.

 

If it’s a Medicaid 1115 waiver, the Biden Administration could make a finding at just about any time under 42 U.S.C. § 431.420(d)(2) that “the demonstration project is not likely to achieve the statutory purposes.”  CMS would have to give a state notice and the opportunity for a hearing before the proposed termination date.  Presumably the hearing would be under 42 C.F.R. §§ 430.60-.104, which include provisions for discovery and post-hearing briefing, and for decisions to take effect no sooner than the end of the quarter in which the CMS administrative decision is made.  You’d think it’d be at least a three to six month process, and of course if a state sought judicial review it could ask for the waiver to remain in effect during judicial review.  If the waiver had already been stayed by a court, as the Arkansas and New Hampshire work requirement waivers have been, or is not in effect, as with the other work requirement waivers, the odds of a court reinstating the waiver during judicial review are pretty slim.

 

If it’s a 1332 waiver, under 45 C.F.R. § 155.1320(d) the Biden Administration could make a finding at just about any time that the waiver does not live up to the statutory guardrails.  There may not be regulations that spell out the hearing process, but under standard 1332 terms and conditions a state is supposed to get at least 90 days to respond, and should then get a hearing of some sort.  Also, the standard terms and conditions suggest that the Department should “align” any termination or suspension of the waiver with the beginning of the following plan year.  That may not be 100% mandatory, but it’d suggest that it might take all of 2021 for CMS to rescind a 1332 waiver.  Also, no telling what’d happen during judicial review.

 

 

 

 

TRUMP ADMINISTRATION AMENDMENTS TO OBAMA ADMINISTRATION REGULATIONS

First, regulation by regulation (45 C.F.R. Parts 144-159); then, Federal Register final rule by final rule.

 

Trump Administration Changes to Obama Administration ACA Regulations (45 C.F.R. Parts 92 and 144-159) (compiled 12/4/20)

 

45 CFR Part 92

Entire part revised or rewritten, 85 FR 37244, June 19, 2020

 

45 CFR Part 144

144.103   Definitions: 83 FR 38243, Aug. 3, 2018; 84 FR 29014, June 20, 2019

 

45 CFR Part 146

146.123   Special rule allowing integration of Health Reimbursement Arrangements (HRAs) and other account-based group health plans with individual health insurance coverage and Medicare and prohibiting discrimination in HRAs and other account-based group health plans: 84 FR 29014, June 20, 2019

146.125   Applicability dates: 83 FR 38243, Aug. 3, 2018

146.150  Guaranteed availability of coverage for employers in the small group market: 84 FR 29024, June 20, 2019; 85 FR 29259, May 14, 2020

146.152   Guaranteed renewability of coverage for employers in the group market: 84 FR 17561, Apr. 25, 2019

 

45 CFR Part 147

147.102   Fair health insurance premiums: 83 FR 17058, Apr. 17, 2018

147.104   Guaranteed availability of coverage: 82 FR 18381, Apr. 18, 2017; 83 FR 17058, Apr. 17, 2018; 85 FR 37247, June 19, 2020

147.106   Guaranteed renewability of coverage: 84 FR 17561, Apr. 25, 2019

147.126   No lifetime or annual limits: 84 FR 29025, June 20, 2019

147.130   Coverage of preventive health services: 82 FR 47833, 47861, Oct. 13, 2017; 85 FR 71202, Nov. 6, 2020

147.131   Accommodations in connection with coverage of certain preventive health services: 82 FR 47833, Oct. 13, 2017, as amended at 82 FR 47861, Oct. 13, 2017; 83 FR 57589, Nov. 15, 2018

147.132   Religious exemptions in connection with coverage of certain preventive health services: 82 FR 47835, Oct. 13, 2017, as amended at 83 FR 57590, Nov. 15, 2018

147.133   Moral exemptions in connection with coverage of certain preventive health services: 82 FR 47861, Oct. 13, 2017, as amended at 83 FR 57630, Nov. 15, 2018

 

45 CFR Part 148

148.102   Scope and applicability date: 83 FR 38243, Aug. 3, 2018

148.122   Guaranteed renewability of individual health insurance coverage: 84 FR 17561, Apr. 25, 2019

 

45 CFR Part 150

[No changes]

 

45 CFR Part 152

[No changes]

 

45 CFR Part 153

153.20   Definitions: 84 FR 17561, Apr. 25, 2019

153.320   Federally certified risk adjustment methodology: 83 FR 17059, Apr. 17, 2018; 84 FR 17561, Apr. 25, 2019

153.630   Data validation requirements when HHS operates risk adjustment: 83 FR 17059, Apr. 17, 2018; 84 FR 17562, Apr. 25, 2019

 

45 CFR Part 154

154.103   Applicability: as amended at 83 FR 17060, Apr. 17, 2018

154.200   Rate increases subject to review: 83 FR 17060, Apr. 17, 2018

154.215   Submission of rate filing justification: 83 FR 17060, Apr. 17, 2018

154.301   CMS’s determinations of Effective Rate Review Programs: 83 FR 17060, Apr. 17, 2018

 

45 CFR Part 155

155.20 Definitions:  84 FR 17562, Apr. 25, 2019

155.106 Election to operate an Exchange after 2014: 83 FR 17060, Apr. 17, 2018

155.120   Non-interference with Federal law and non-discrimination standards: 85 FR 37247, June 19, 2020

155.200   Functions of an Exchange: 83 FR 17060, Apr. 17, 2018; 84 FR 71710, Dec. 27, 2019

155.205   Consumer assistance tools and programs of an Exchange: 84 FR 17563, Apr. 25, 2019

155.210   Navigator program standards: 83 FR 17061, Apr. 17, 2018; 84 FR 17563, Apr. 25, 2019

155.215   Standards applicable to Navigators and Non-Navigator Assistance Personnel carrying out consumer assistance functions under §§155.205(d) and (e) and 155.210 in a Federally-facilitated Exchange and to Non-Navigator Assistance Personnel funded through an Exchange Establishment Grant: Apr. 17, 2018; 84 FR 17563, Apr. 25, 2019

155.220   Ability of States to permit agents and brokers and web-brokers to assist qualified individuals, qualified employers, or qualified employees enrolling in QHPs: 84 FR 17563, Apr. 25, 2019; 85 FR 37248, June 19, 2020

155.221   Standards for direct enrollment entities and for third-parties to perform audits of direct enrollment entities: 83 FR 17061, Apr. 17, 2018, as amended at 84 FR 17566, Apr. 25, 2019

155.305   Eligibility standards: 83 FR 17061, Apr. 17, 2018

155.320   Verification process related to eligibility for insurance affordability programs: 83 FR 17061, Apr. 17, 2018

155.330   Eligibility redetermination during a benefit year: 84 FR 71710, Dec. 27, 2019; 85 FR 29259, May 14, 2020

155.400   Enrollment of qualified individuals into QHPs: 82 FR 18381, Apr. 18, 2017; 85 FR 29260, May 14, 2020

155.410   Initial and annual open enrollment periods: 82 FR 18381, Apr. 18, 2017

155.415   Allowing issuer or direct enrollment entity application assisters to assist with eligibility applications: 84 FR 17567, Apr. 25, 2019

155.420   Special enrollment periods: 82 FR 18381, Apr. 18, 2017; 83 FR 17062, Apr. 17, 2018; 84 FR 17567, Apr. 25, 2019; 84 FR 29027, June 20, 2019; 85 FR 29260, May 14, 2020

155.430   Termination of Exchange enrollment or coverage: 83 FR 17063, Apr. 17, 2018; 85 FR 29260, May 14, 2020

155.500   Definitions: 83 FR 17063, Apr. 17, 2018

155.605   Eligibility standards for exemptions: 83 FR 17063, Apr. 17, 2018; 84 FR 17567, Apr. 25, 2019

155.610   Eligibility process for exemptions: 83 FR 17064, Apr. 17, 2018

155.700   Standards for the establishment of a SHOP: 83 FR 17064, Apr. 17, 2018

155.705   Functions of a SHOP for plan years beginning prior to January 1, 2018: 83 FR 17064, Apr. 17, 2018

155.706   Functions of a SHOP for plan years beginning on or after January 1, 2018: 83 FR 17064, Apr. 17, 2018

155.715   Eligibility determination process for SHOP for plan years beginning prior to January 1, 2018: 83 FR 17065, Apr. 17, 2018

155.716   Eligibility determination process for SHOP for plan years beginning on or after January 1, 2018: 83 FR 17065, Apr. 17, 2018

155.720   Enrollment of employees into QHPs under SHOP for plan years beginning prior to January 1, 2018: 83 FR 17066, Apr. 17, 2018

155.721   Record retention and IRS Reporting for plan years beginning on or after January 1, 2018: 83 FR 17066, Apr. 17, 2018

155.725   Enrollment periods under SHOP for plan years beginning prior to January 1, 2018: 82 FR 18382, Apr. 18, 2017; 83 FR 17066, Apr. 17, 2018

155.726   Enrollment periods under SHOP for plan years beginning on or after January 1, 2018: 83 FR 17066, Apr. 17, 2018

155.730   Application standards for SHOP for plan year beginning prior to January 1, 2018: 83 FR 17066, Apr. 17, 2018

155.731   Application standards for SHOP for plan years beginning on or after January 1, 2018: 83 FR 17066, Apr. 17, 2018

155.735   Termination of SHOP enrollment or coverage for plan years beginning prior to January 1, 2018: 83 FR 17067, Apr. 17, 2018

155.740   SHOP employer and employee eligibility appeals requirements for plan years beginning prior to January 1, 2018: 83 FR 17067, Apr. 17, 2018

155.741   SHOP employer and employee eligibility appeals requirements for plan year beginning on or after January 1, 2018: 83 FR 17067, Apr. 17, 2018

155.1200   General program integrity and oversight requirements: 84 FR 71710, Dec. 27, 2019

155.1318   Modification from the normal public notice requirements during the public health emergency: 85 FR 71202, Nov. 6, 2020

155.1320   Monitoring and compliance: 85 FR 71203, Nov. 6, 2020

155.1400   Quality rating system: 85 FR 29261, May 14, 2020

155.1405   Enrollee satisfaction survey system: 85 FR 29261, May 14, 2020

 

45 CFR Part 156

156.20   Definitions: 84 FR 17567, Apr. 25, 2019; 85 FR 29261, May 14, 2020

156.50   Financial support: 83 FR 62498, Dec. 4, 2018

156.100   State selection of benchmark plan for plan years beginning prior to January 1, 2020: 83 FR 17068, Apr. 17, 2018

156.111   State selection of EHB-benchmark plan for plan years beginning on or after January 1, 2020, and annual reporting of state-required benefits: 83 FR 17068, Apr. 17, 2018, as amended at 85 FR 29261, May 14, 2020

156.115   Provision of EHB: 83 FR 17069, Apr. 17, 2018

156.130   Cost-sharing requirements: 84 FR 17567, Apr. 25, 2019; 85 FR 29261, May 14, 2020

156.140   Levels of coverage: 82 FR 18382, Apr. 18, 2017

156.150   Application to stand-alone dental plans inside the Exchange: 83 FR 17069, Apr. 17, 2018

156.200   QHP issuer participation standards: 83 FR 17069, Apr. 17, 2018; 85 FR 37248, June 19, 2020

156.221   Access to and exchange of health data and plan information: 85 FR 25638, May 1, 2020

156.265   Enrollment process for qualified individuals: 85 FR 29261, May 14, 2020

156.270   Termination of coverage or enrollment for qualified individuals: 85 FR 29261, May 14, 2020

156.280   Separate billing and segregation of funds for abortion services: as amended at 84 FR 71710, Dec. 27, 2019; 85 FR 2888, Jan. 17, 2020; 85 FR 27629, May 8, 2020

156.285   Additional standards specific to SHOP for plan years beginning prior to January 1, 2018: 83 FR 17069, Apr. 17, 2018

156.286   Additional standards specific to SHOP for plan years beginning on or after January 1, 2018: 83 FR 17069, Apr. 17, 2018

156.340   Standards for downstream and delegated entities: as amended at 83 FR 17069, Apr. 17, 2018

156.350   Eligibility and enrollment standards for Qualified Health Plan issuers on State-based Exchanges on the Federal platform: 83 FR 17069, Apr. 17, 2018

156.1210   Dispute submission: 85 FR 29262, May 14, 2020

156.1230   Direct enrollment with the QHP issuer in a manner considered to be through the Exchange: 83 FR 17070, Apr. 17, 2018; 84 FR 17568, Apr. 25, 2019; 85 FR 37248, June 19, 2020

 

45 CFR Part 157

157.205   Qualified employer participation process in a SHOP for plan years beginning prior to January 1, 2018: 83 FR 17070, Apr. 17, 2018

157.206   Qualified employer participation process in a SHOP for plan years beginning on or after January 1, 2018: 83 FR 17070, Apr. 17, 2018

 

45 CFR Part 158

158.110   Reporting requirements related to premiums and expenditures: 85 FR 29262, May 14, 2020

158.140   Reimbursement for clinical services provided to enrollees: 85 FR 29262, May 14, 2020

158.150   Activities that improve health care quality: 85 FR 29262, May 14, 2020

158.160   Other non-claims costs: as amended at 85 FR 29262, May 14, 2020

158.170   Allocation of expenses: as amended at 83 FR 17070, Apr. 17, 2018

158.221   Formula for calculating an issuer’s medical loss ratio: 83 FR 17070, Apr. 17, 2018

158.301   Standard for adjustment to the medical loss ratio: 83 FR 17070, Apr. 17, 2018

158.321   Information regarding the State’s individual health insurance market: 83 FR 17070, Apr. 17, 2018

158.322   Proposal for adjusted medical loss ratio: 83 FR 17071, Apr. 17, 2018

158.330   Criteria for assessing request for adjustment to the medical loss ratio: 83 FR 17071, Apr. 17, 2018

158.341   Treatment as a public document: 83 FR 17071, Apr. 17, 2018

158.350   Subsequent requests for adjustment to the medical loss ratio: 83 FR 17071, Apr. 17, 2018

 

45 CFR Part 159

[No changes]

 

In the Federal Register:

Trump Administration Amendments to Obama Administration Regulations (compiled 12/4/20)

 

Patient Protection and Affordable Care Act; Market Stabilization, 82 Fed. Reg., 18,346 (April 18, 2017), amending 45 C.F.R. §§ 147.104, 155. 155.410, 155.420, 155.725, and 156.140.

https://www.govinfo.gov/content/pkg/FR-2017-04-18/pdf/2017-07712.pdf

 

 

Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 82 Fed. Reg. 47,792 (Oct. 13, 2017), amending various regulations, including 45 C.F.R. §§ 147.130, 147.131, and 147.132.

https://www.govinfo.gov/content/pkg/FR-2017-10-13/pdf/2017-21851.pdf

 

 

Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 82 Fed. Reg. 47,838 (Oct. 13, 2017), amending various regulations, including 45 C.F.R. §§ 147.130, 147.131, and 147.133.

https://www.govinfo.gov/content/pkg/FR-2017-10-13/pdf/2017-21852.pdf

 

 

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019, 83 Fed. Reg. 16,930 (April 17, 2018), amending 45 C.F.R. §§ 147.102, 147.104, 153.320, 153.630, 154.103, 154.200, 154.215, 154.301, 155.106, 155.200, 155.210, 155.215, 155.221, 155.305, 155.320, 155.420, 155.430, 155.500, 155.605, 155.610, 155.700, 155.705, 155.706, 155.715, 155.716, 155.720, 155.721, 155.725, 155.726, 155.730, 155.731, 155.735, 155.740, 155.741, 156.100, 156.111, 156.115, 156.150, 156.200, 156.285, 156.286, 156.298 (removed), 156.340, 156.350, 156.1230, 157.205, 157.206, 158.170, 158.221, 158.301, 158.321, 158.322, 158.330, 158.341, and 158.350.

https://www.govinfo.gov/content/pkg/FR-2018-04-17/pdf/2018-07355.pdf

 

 

Short-Term, Limited-Duration Insurance, 83 Fed. Reg. 38,212 (Aug. 3, 2018), amending various regulations plus 45 C.F.R. §§ 144.103, 146.125, and 148.102.

https://www.govinfo.gov/content/pkg/FR-2018-08-03/pdf/2018-16568.pdf

 

 

Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 83 Fed. Reg. 57,536 (Nov. 15, 2018), amending various regulations, including 45 C.F.R. §§ 147.131 and 147.132.

https://www.govinfo.gov/content/pkg/FR-2018-11-15/pdf/2018-24512.pdf

 

 

Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 83 Fed. Reg. 57,592 (Nov. 15, 2018), amending various regulations, including 45 C.F.R. § 147.133.

https://www.govinfo.gov/content/pkg/FR-2018-11-15/pdf/2018-24514.pdf

 

 

Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment, 83 Fed. Reg. 62,496 (Dec. 4, 2018), amending 45 C.F.R. § 156.50.

https://www.govinfo.gov/content/pkg/FR-2018-12-04/pdf/2018-26332.pdf

 

 

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020, 84 Fed. Reg. 17454 (April 25, 2019), amending 45 C.F.R. §§ 146.152, 147.106, 148.122, 153.20, 153.320, 153.630, 155.20, 155.205, 155.210, 155.215, 155.220, 155.221, 155.415, 155.420, 155.605, 156.20, 156.130, and 156.1230.

https://www.govinfo.gov/content/pkg/FR-2019-04-25/pdf/2019-08017.pdf

 

 

Health Reimbursement Arrangements and Other Account-Based Group Health Plans, 84 Fed. Reg., 28,888 (June 20, 2019), amending various regulations plus 45 C.F.R. §§ 144.103, 146.123, 146.145, 147.126, and 155.420.

https://www.govinfo.gov/content/pkg/FR-2019-06-20/pdf/2019-12571.pdf

 

 

Patient Protection and Affordable Care Act; Exchange Program Integrity, 84 Fed. Reg. 17,674 (Dec. 27, 2019), amending 45 C.F.R. §§ 155.200, 155.1200, and 156.280.

https://www.govinfo.gov/content/pkg/FR-2019-12-27/pdf/2019-27713.pdf

 

 

Patient Protection and Affordable Care Act; Exchange Program Integrity Correction, 85 Fed. Reg. 2888 (Jan. 17, 2020), amending 45 C.F.R. § 156.280.

https://www.govinfo.gov/content/pkg/FR-2020-01-17/pdf/C1-2019-27713.pdf

 

 

Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers, 85 Fed. Reg. 25,210 (May 1, 2020), amending many regulations, including 45 C.F.R. § 156.221.

https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-05050.pdf

 

 

Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID– 9 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program, 85 Fed. Reg. 27, 550 (May 8, 2020), amending 45 C.F.R. § 156.280.

https://www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf

 

 

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans; Final Rule, 85 Fed. Reg. 29,164 (May 14, 2020), amending 45 C.F.R. §§ 146.145, Part 149 (removed), 155.330, 155.400, 155.420, 155.430, 155.1400, 155.1405, 156.20, 156.111, 156.130, 156.265, 156.270, 156.1210, 158.110, 158.140, 158.150, and 158.160.

https://www.govinfo.gov/content/pkg/FR-2020-05-14/html/2020-10045.htm

 

 

Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority, 85 Fed. Reg. 37,160 (June 19, 2020), amending various regulations, especially 45 C.F.R. Part 92 and 45 C.F.R. §§ 147.104, 155.120, 155.220, 156.200, and 156.1230.

https://www.govinfo.gov/content/pkg/FR-2020-06-19/pdf/2020-11758.pdf

 

 

Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency, 85 Fed. Reg. 71,142 (Nov. 6, 2020), amending various regulations, including 45 C.F.R. §§ 147.130, 155.1318, and 155.1320.

https://www.govinfo.gov/content/pkg/FR-2020-11-06/pdf/2020-24332.pdf

 

 

Trump Administration Changes to Prior Medicaid Regulations (42 C.F.R. Parts 430-457]) (compiled 12/5/20)

 

42 C.F.R. Part 430

[No changes]

 

42 C.F.R. Part 431

431.60   Beneficiary access to and exchange of data: 85 FR 25634, May 1, 2020

431.70   Access to published provider directory information: 85 FR 25635, May 1, 2020

431.800   Basis and scope: 82 FR 31182, July 5, 2017

431.804   Definitions: 82 FR 31182, July 5, 2017

431.806   State requirements: 82 FR 31183, July 5, 2017

431.810   Basic elements of the Medicaid Eligibility Quality Control (MEQC) Program: 82 FR 31183, July 5, 2017

431.812   Review procedures: 82 FR 31183, July 5, 2017

431.814   Pilot planning document: 82 FR 31183, July 5, 2017

431.816   Case review completion deadlines and submittal of reports: 82 FR 31183, July 5, 2017

431.818   Access to records: 82 FR 31184, July 5, 2017

431.820   Corrective action under the MEQC program: 82 FR 31184, July 5, 2017

431.950   Purpose: 82 FR 31184, July 5, 2017

431.958   Definitions and use of terms: 82 FR 31184, July 5, 2017

431.960   Types of payment errors: 82 FR 31185, July 5, 2017

431.970   Information submission and systems access requirements: 82 FR 31185, July 5, 2017

431.972   Claims sampling procedures: 82 FR 31186, July 5, 2017

431.992   Corrective action plan: 82 FR 31186, July 5, 2017

431.998   Difference resolution and appeal process: 82 FR 31187, July 5, 2017

431.1010   Disallowance of Federal financial participation for erroneous State payments (for PERM review years ending after July 1, 2020): 82 FR 31187, July 5, 2017

 

42 C.F.R. Part 432

[No changes]

 

42 C.F.R. Part 433

433.400   Continued enrollment for temporary FMAP increase: 85 FR 71197, Nov. 6, 2020

 

42 C.F.R. Part 434

[No changes]

 

42 C.F.R. Part 435

[No changes]

 

42 C.F.R. Part 436

[No changes]

 

42 C.F.R. Part 438

438.3   Standard contract requirements: as amended at 85 FR 37243, June 19, 2020, 85 FR 72837, Nov. 13, 2020

438.4   Actuarial soundness: 85 FR 72837, Nov. 13, 2020

438.5   Rate development standards: 85 FR 72838, Nov. 13, 2020

438.6   Special contract provisions related to payment: 85 FR 72838 and 72839, Nov. 13, 2020

438.7   Rate certification submission: 85 FR 72839, Nov. 13, 2020

438.8   Medical loss ratio (MLR) standards: 85 FR 72840, Nov. 13, 2020

438.9   Provisions that apply to non-emergency medical transportation PAHPs: 85 FR 72840, Nov. 13, 2020

438.10   Information requirements: 85 FR 72840, Nov. 13, 2020

438.54   Managed care enrollment: 85 FR 72840, Nov. 13, 2020

438.56   Disenrollment: Requirements and limitations: 85 FR 72840, Nov. 13, 2020

438.62   Continued services to enrollees: as amended at 85 FR 25635, May 1, 2020

438.68   Network adequacy standards: 85 FR 72840, Nov. 13, 2020

438.206   Availability of services: as amended at 85 FR 37243, June 19, 2020

438.210   Coverage and authorization of services: 84 FR 15843, April 16, 2019

438.236   Practice guidelines: 85 FR 27841, Nov. 13, 2020

438.242   Health information systems: as amended at 85 FR 25635, May 1, 2020, 85 FR 27841, Nov. 13, 2020

438.334   Medicaid managed care quality rating system: 85 FR 27841, Nov. 13, 2020

438.340   Managed care State quality strategy: 85 FR 27841, Nov. 13, 2020

438.358   Activities related to external quality review: 82 FR 12510, Mar. 6, 2017, 85 FR 27841, Nov. 13, 2020

438.362   Exemption from external quality review: 85 FR 27842, Nov. 13, 2020

438.364   External quality review results: 85 FR 27842, Nov. 13, 2020

438.400   Statutory basis, definitions, and applicability: 84 FR 15844, April 16, 2019, 85 FR 72842, Nov. 13, 2020

438.402   General requirements: 84 FR 15844, April 16, 2019, 85 FR 72842, Nov. 13, 2020

438.406   Handling of grievances and appeals, 85 FR 72842, Nov. 13, 2020

438.408   Resolution and notification: Grievances and appeals: 85 FR 72842, Nov. 13, 2020

 

42 C.F.R. Part 440

440.20   Outpatient hospital services and rural health clinic services: 85 FR 72909, Nov. 16, 2020

440.30   Other laboratory and X-ray services: 85 FR 27626, May 8, 2020

440.70   Home health services: 85 FR 19291, Apr. 6, 2020; 85 FR 27626, May 8, 2020

440.262   Access and cultural conditions: 85 FR 37243, June 19, 2020

 

42 C.F.R. Part 441

441.17   Laboratory services: 85 FR 72909, Nov. 16, 2020

441.18   Case management services: 85 FR 72909, Nov. 16, 2020

441.184   Emergency preparedness: as amended at 84 FR 51816, Sept. 30, 2019

 

42 C.F.R. Part 442

[No changes]

 

42 C.F.R. Part 447

447.10   Prohibition against reassignment of provider claims: 84 FR 19728, May 6, 2019

447.294   Medicaid disproportionate share hospital (DSH) allotment reductions: as amended at 84 FR 50332, Sept. 25, 2019

447.299   Reporting requirements: 82 FR 16122, Apr. 3, 2017, 85 FR 72909, Nov. 16, 2020

447.502   Definitions: 84 FR 64786, Nov. 25, 2019

447.509   Medicaid drug rebates (MDR): as amended at 84 FR 12136, Apr. 1, 2019

 

42 C.F.R. Part 455

455.21   Cooperation with State Medicaid fraud control units: as amended at 84 FR 10713, Mar. 22, 2019

455.101   Definitions: 84 FR 47856, Sept. 10, 2019

455.103   State plan requirement: 84 FR 47856, Sept. 10, 2019

455.107   Disclosure of affiliations: 84 FR 47856, Sept. 10, 2019

 

42 C.F.R. Part 456

[No changes]

 

42 C.F.R. Part 457

457.628   Other applicable Federal regulations: 82 FR 31187, July 5, 2017

457.700   Basis, scope, and applicability: as amended at 85 FR 25635, May 1, 2020

457.730   Beneficiary access to and exchange of data: 85 FR 25636, May 1, 2020

457.760   Access to published provider directory information: 85 FR 25637, May 1, 2020

457.990   Provider and supplier screening, oversight, and reporting requirements: as amended at 84 FR 47857, Sept. 10, 2019

457.1207   Information requirements: 85 FR 72842, Nov. 13, 2020

457.1233   Structure and operation standards: 85 FR 25637, May 1, 2020, 85 FR 72842, Nov. 13, 2020

457.1240   Quality measurement and improvement: 85 FR 72842, Nov. 13, 2020

457.1260   Grievance system: 85 FR 72842, Nov. 13, 2020

457.1270   Sanctions: 85 FR 72843, Nov. 13, 2020

457.1285   Program integrity safeguards: 85 FR 72844, Nov. 13, 2020

 

 

Federal Register:

Medicaid Program; Disproportionate Share Hospital Payments—Treatment of Third Party Payers in Calculating Uncompensated Care Costs, 82 Fed. Reg. 16,114 (April 3, 2017), amending 42 C.F.R. sec. 447.299.

2017-06538

 

Medicaid/CHIP Program; Medicaid Program and Children’s Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control
and Payment Error Rate Measurement Programs in Response to the Affordable Care Act, 82 Fed. Reg. 31,158 (July 5, 2017), amending 42 C.F.R. secs. 431.800, 431.804, 431.806, 431.810, 431.812, 431.814 431.816, 431.818, 431.820, 431.822 (removed), 431.861-.866 (removed), 431.950, 431.958, 431.960, 431.970, 431.972, § 431.974 [Removed], § 431.978 [Removed], § 431.980 [Removed], § 431.988 [Removed], 431.992, 431.998, 431.1010, 457.628.

2017-13710

 

Medicaid; Revisions to State Medicaid Fraud Control Unit Rules, 84 Fed. Reg. 10,700 (March 22, 2019), amending various regulations, including 42 C.F.R. sec 455.21.

2019-05362-1

 

Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs, 84 Fed. Reg. 12,130 (April 1, 2019), amending 42 C.F.R. sec. 447.509.

2019-06274-1

 

Medicaid Program; Reassignment of Medicaid Provider Claims, 84 Fed. Reg. (May 6, 2019), amending 42 C.F.R. sec. 447.10.

2019-09118-1

 

Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process, 84 Fed. Reg. 47,794 (Sept. 10, 2019), amending various regulations, including 42 C.F.R. secs. 455.101, 455.103, 455.107, and 457.990.

2019-19208-2

 

Medicaid Program; State Disproportionate Share Hospital Allotment Reductions, 84 Fed. Reg. 50,308 (Sept. 25, 2019), amending 42 C.F.R. sec. 447.294.

2019-20731-1

 

Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care, 84 Fed. Reg., (Sept. 30, 2019), amending various regulations, including 42 C.F.R. sec. 441.184.

2019-20736-1

 

Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States, 84 Fed. Reg., 64,783 (Nov. 25, 2019), amending 42 C.F.R. sec. 447.502.

2019-25514-2

 

Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage
Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified
Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers, 85 Fed. Reg. 25,210 (May 1, 2020), amending many regulations, including 42 C.F.R. secs. 431.60, 431.70, 438.62, 438.242, 457.700, 457.730, 457.760, and 457.1233.

2020-05050

 

Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority, 85 Fed. Reg. 37,160 (June 19, 2020), amending various regulations, especially 45 C.F.R. Part 92, and 42 C.F.R. §§ 438.3, 438.206, and 440.262.

https://www.govinfo.gov/content/pkg/FR-2020-06-19/pdf/2020-11758.pdf

 

Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency, 85 Fed. Reg. 71,142 (Nov. 6, 2020), adding 42 C.F.R. sec. 433.400.

2020-24332

 

Medicaid Program; Medicaid and Children’s Health Insurance Program (CHIP) Managed Care, 85 Fed. Reg. 72,754 (Nov. 13, 2020), amending 42 C.F.R. secs. 438.3, 438.4, 438.5, 438.6, 438.7, 438.8, 438.9, 438.10, 438.54, 438.56, 438.68, 438.236, 438.242, 438.334, 438.340, 438.358, 438.362, 438.364, 438.400, 438.402, 438.406, 438.408, 457.1207, 457.1240, 457.1260, 457.1270, and 457.1285.

2020-24758

 

Regulatory Clean Up Initiative, 85 Fed. Reg. 72,899 (Nov. 16, 2020), amending various regulations, including 42 C.F.R. secs. 440.20, 441.17, 441.18, and 447.299.

2020-21774-1

 

 

RECENT TRUMP ADMINISTRATION POLICIES AND PROPOSED REGULATIONS ON THE REGULATORY PROCESS

 

Guidance

Department of Health and Human Services Good Guidance Practices, 85 Fed. Reg. 51,396 (Aug. 20, 2020)

2020-18208

Comment deadline: Sept. 16, 2020

Final regulation, 85 Fed. Reg. 78,770 (Dec. 7, 2020)

2020-26832

45 cfr part 1

 

 

Non-duplication

Policy on Redundant, Overlapping, or Inconsistent Regulations, 85 Fed. Reg. 75893 (Nov. 27, 2020)

2020-26023

memorandum-on-non-duplicative-rules-final

Status (11/29): Per the policy statement, “Effective immediately, all agencies and offices of the Department that prepare regulations must ensure that any rule is not inconsistent with, and does not overlap with, any regulation that has already been issued through an agency within the Department.”

 

Regulatory review

Securing Updated and Necessary Statutory Evaluations Timely, 85 Fed. Reg. 70,097 (Nov. 4, 2020)

2020-23888

Comment deadline: Dec. 4, 2020

Status (11/29): in comment period

Press release,

https://www.hhs.gov/about/news/2021/01/08/hhs-finalizes-unprecedented-regulatory-reform.html

Final rule (non Federal Register version)

combined-final-rule-ii

Securing Updated and Necessary Statutory Evaluations Timely

Editorial Note: The Office of the Federal Register made technical corrections to this document after it was posted for public display. It will remain on display through the close of business on January 19, 2021.

2021-00597

 

 

Transparency

Public Access to Materials Underlying Impact Analyses; Statement of Policy, 85 Fed. Reg. 75893 (Nov. 27, 2020)

2020-25957

Status (11/29): Per the policy statement, “Effective for any rulemaking or demonstration project proposed after November 30, 2020”

 

RECENTLY PROPOSED NOTICE OF BENEFIT AND PAYMENT PARAMETERS FOR 2022, WITH PROPOSED REGULATIONS

Trump Administration proposed notice for 2022:
 
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations, November 25, 2020
 
 
Federal Register version, 85 Fed. Reg. 78,572 (Dec. 4, 2020)
 
 
HHS fact sheet, November 25, 2020
 

 

FOUR YEARS AGO — THE 2016-2017 TRANSITION

Maeve P. Carey, Can a New Administration Undo a Previous Administration’s Regulations? (Congressional Research Service, November 21, 2016)

IN10611

“Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal,” January 20, 2017

OMB Memorandum — Regulatory Freeze Pending Review, 82 Fed. Reg. 8346 (Jan. 24, 2017)

2017-01766

 

Complicated 2016-17 Transitions, Example 1: 1557

The political flash point in the Obama Administration’s 1557 regulations was the protection it offered for people who are transgender.  Things were controversial enough that the regulations were delayed and, when finalized, had a delayed effective date, putting their effective date at the beginning of 2017, that is, after the 2016 general election.

Obama Administration: Nondiscrimination in Health Programs and Activities; Final Rule, 81 Fed. Reg. 31376 (May 18, 2016)

2016-11458

Various religious organizations and states like Texas sued, in Judge Reed O’Connor’s court. 

Franciscan Alliance v. Burwell, No. 7:16-cv-108 (N.D. Tex.),

Complaint, August 23, 2016

Complaint 177110100373

Organizations representing people who would benefit from the new regulation promptly moved to intervene, a process which should have been simple but turned out to be complicated, time-consuming, and not completely successful.  Note that the Obama Administration, before the election, opposed the motion to intervene.

Motion to intervene, September 16, 2016

Intervenors mo 177110158316

US opposition to motion to intervene, October 7, 2016

govt op to mo to intervene

Order re extension of time re mo to intervene, October 7, 2016

extension of time order re mo to intervene

A couple of weeks before the election, plaintiffs moved for summary judgment or a preliminary injunction.

First amended complaint, October 17, 2016

First Amended Complaint 177110227088

State plaintiffs’ motion for partial summary judgment or preliminary injunction, October 21, 2016

State Plaintiffs MSJ PI 177110241326

Private plaintiffs’ motion for partial summary judgment or preliminary injunction, October 21, 2016

Private Plaintiffs MSJ PI 177110241373

After the election, with not much time to go before the regulations’ effective date, the litigation heated up, with Judge O’Connor dramatically entering a preliminary injunction on New Year’s Eve.  There was parallel litigation, with the same result, in North Dakota.

US PI opposition, November 23, 2016

US PI op 177110321952

Putative intervenors’ PI opposition, November 23, 2016

Intervenors PI op 177110322191

State plaintiffs’ PI reply, December 2, 2016

State plaintiffs PI reply 177110338867

Private plaintiffs’ PI reply, December 2, 2016

Private Plaintiffs PI RB 177110339534

Order (December 31, 2016)

Franciscan Alliance PI order

The same thing happened in parallel North Dakota litigation, which resulted in a sealed non-enforcement order.

Complaint in The Religious Sisters of Mercy v. Burwell, No. 3:16-cv-386 (filed November 7, 2016) 1026880-0–2510

Complaint in Catholic Benefits Ass’n v. Burwell, No. 3:16-cv-432 (filed December 28, 2016) 1040482-0–2480

12/30/2016 23  SEALED ORDER Staying Enforcement by Judge Ralph R. Erickson.(SH) (Entered: 12/30/2016)

In Franciscan Alliance, Judge O’Connor had granted a preliminary injunction before ruling on the motion to intervene by people needing section 1557’s protections; but, after the Trump Administration took office, Judge O’Connor denied intervention, on dubious grounds, denying putative intervenors intervention as of right but holding undecided their backup request for permissive intervention.  That would prevent putative intervenors from getting their claims heard by the Fifth Circuit.  Judge O’Connor would not grant permissive intervention until 2019.

Order denying 24(a) intervention and stay (January 24, 2017)

FA order denying ACLU 24 a motion

Fifth Circuit action on putative intervenors’ appeal (June 30, 2017)

5C FA circuit order

The Trump Administration then announced its intention to reconsider the rule, and asked for a voluntary remand.  Plaintiffs argued that statements of intentions were all very well but they needed a ruling on the merits.  Judge O’Connor noted in July 2017 that HHS could reconsider the rule without needing permission from him, and held that he would retain jurisdiction over the case while staying proceedings.

US motion for voluntary remand and stay (May 2, 2017)

US motion for voluntary remand and stay

Plaintiffs’ opposition to voluntary remand (May 4, 2017)

Franciscan Alliance voluntary remand op

US voluntary remand reply (May 18, 2017)

Franciscan Alliance voluntary remand reply

Scheduling order (June 13, 2017)

scheduling order for 6 26 17 hearing

Order re voluntary remand and stay (July 10, 2017)

Order re voluntary remand and stay

The same thing happened in the parallel North Dakota litigation.

North Dakota v. Burwell, No. 3:16-cv-386 (D. N.D.), US motion for voluntary remand/stay, May 26, 2017 1091550-0–16594

Plaintiffs’ request for additional stay, May 30, 20171091698-0–30199

Plaintiffs’ response to US motion for voluntary remand, June 9, 20171095695-0–30256

US EEOC op to stay, June 13, 20171096702-0–30292

Plaintiffs’ reply in support of stay, June 20, 20171098624-0–30332

US notice of supplemental authority, July 12, 20171104175-0–3557

Stay but no remand order, August 24, 20171118387-0–4693

Almost two years passed before the Trump Administration finally proposed revised 1557 regulations.  Despite the protection of Judge O’Connor’s preliminary injunction, plaintiffs proceeded to move for summary judgment, seeking a ruling that HHS could not force them to provide particular services to people who were transgender.

Proposed rule: HHS, Nondiscrimination in Health and Health Education Programs or Activities, 84 Fed. Reg. 27846 (June 14, 2019)

2019-11512

States’ motion for summary judgment, summary judgment memo, and appendix (February 4, 2019)

FA motion for summary judgment

FA summary judgment memo

FA summary judgment appendix

Franciscan Alliance motion for summary judgment, summary judgment memo, and appendix (February 4, 2019)

FA private motion SJ

FA private SJ memo

FA private SJ appendix

In due course Judge O’Connor did grant summary judgment to the plaintiffs, but denied them the permanent relief they were looking for.  They appealed, and the appeal remains pending (Thanksgiving Day 2020).

Memorandum opinion and order, and final judgment, October 15, 2019

FA memorandum op and order 10 15 19

FA final judgment 10 15 19

Order staying other issues, October 15, 2019

FA stay other issues

US motion to modify final judgment, November 12, 2019

US motion to modify final judgment

Order for response by 11/20, November 13, 2019

Order directing response

States’ response to US motion to modify, November 20, 2019

State response to US motion to alter amend

Private plaintiffs’ response to US motion, November 20, 2019

FA response to US mo to alter amend

Order modifying judgment, November 21, 2019

Order modifying final judgment

Franciscan Alliance notice of appeal, January 21, 2020

Notice of appeal FA

Fifth Circuit # 20-10093

Meanwhile, in the parallel North Dakota litigation, summary judgment briefing is underway, with plaintiffs having started the litigation back up November 6, 2020 … the Friday after the 2020 general election.  Go figure.

Plaintiffs’ unopposed motion to lift stay, November 6, 2020

1477580-0–10163

Plaintiffs’ motion for summary judgment, including memorandum in support and exhibits, November 23, 2020

merged_31918_-1-1606178706

For more on Franciscan Alliance and the North Dakota 1557 case, see https://affordablecareactlitigation.com/aca-enforcement-directly-and-1557/

 

 

Complicated 2016-17 Transitions, Example 2: Cost Sharing Reductions Payments

House v. Burwell, No. 1:14-cv-1967 (D. D.C.), on appeal, No. 16-5202 (D.C. Cir.)

Before the 2016 election, Judge Collyer had ruled, first, that the House had standing to sue the Obama Administration under the Appropriations Clause, and, second, that there was not an appropriation supporting cost-sharing reductions payments.  She had entered judgment to this effect but had stayed her ruling pending appeal.  The Obama Administration had appealed to the D.C. Circuit and filed an opening brief.

Two weeks after the election, the House asked the D.C. Circuit to hold the appeal in abeyance, saying among other things that it had been in discussions with the Trump transition team and there was a possibility that the case might settle.  The Obama Administration opposed the motion, but the D.C. Circuit granted it.

House motion to hold appeal in abeyance, 11/21/2016

Government opposition to holding appeal in abeyance, 11/23/2016

House reply supporting abeyance, 11/28/2016

Abeyance order, 12/5/2016

Two individuals then attempted to intervene to defend continued payments, but the D.C. Circuit denied their motion.

Patton Parker motion to intervene and affidavits, 12/20/2016

Patton affidavit

Federal response to motion to intervene, 12/23/2016

House notice re motion to intervene, 12/23/2016

Patton Parker emergency motion partly to lift abeyance, 12/27/2016

House op to lifting abeyance, 12/28/2016

Patton Parker reply supporting partly lifting abeyance, 12/28/2016

D.C. Circuit order directing responses, 12/29/2016

US op to mo to intervene, 1/6/2017

House op to motion to intervene, 1/6/2017

Patton Parker reply supporting intervention, 1/11/2017

Order denying Patton Parker intervention, 1/12/2017

order denying motion to intervene

After the Trump Administration took office, the abeyance continued through May 2017.  Several States attempted to intervene to defend the continuing payments, and this time the D.C. Circuit granted their motion.

Parties’ joint motion to continue abeyance, 2/21/2017

Continued abeyance order, 3/2/2017

States’ motion to intervene and motion to lift abeyance, 5/18/2017

States interv mo to lift abeyance

Joint status report, 5/22/2017

US op lift abeyance, 5/26/2017

House op lift abeyance, 5/30/2017

States’ abeyance reply, 6/2/2017

Notice of intent to intervene by NC and VA, 6/5/2017

Order requesting response to state intervention motions, 6/22/2017

House opposition to state intervention motion, 7/10/2017

HHS opposition to state intervention motion, 7/10/2017

States’ intervention reply, 7/17/2017

Order granting states’ intervention motion, 8/1/2017

The Trump Administration then, in October 2017, stopped making cost-sharing reductions payments.

Government notices, 10/13/2017, with Sessions memo, 10/12

States’ status report, 10/30/2017

Joint US House US Govt status report, 10/30/2017

The parties then settled, although settlement took several months.  A main issue was that the United States did not want to set a precedent that the U.S. House could sue it.  The D.C. Circuit asked for, and got, briefing supporting the settlement.  The case was closed in May 2018, and cost-sharing reductions payments have not been made since September 2017.

District court ‘motion for indicative ruling,’ 12/15/2017

D.C. Circuit joint report, 12/15/2017

District court order, 1/16/2018

Joint motion for remand, 1/19/2018

Order, 3/5/2018

16 5202 Order regarding joint motion to dismiss

Supplement in support of joint motion for remand, 4/11/2018

Order granting joint motion to dismiss and remand, 5/16/2018

Order closing case, 5/18/2018

 

 

 

 

 

 

 

POLICY REVERSALS CASE LAW

 

FCC v. Fox Television, 556 U.S. 502, 513-16 (2009)

FCC v Fox Television Stations Inc.doc

The Administrative Procedure Act, 5 U.S.C. § 551 et seq., which sets forth the full extent of judicial authority to review executive agency action for procedural correctness, see Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc., 435 U.S. 519, 545–549, 98 S.Ct. 1197, 55 L.Ed.2d 460 (1978), permits (insofar as relevant here) the setting aside of agency action that is “arbitrary” or “capricious,” 5 U.S.C. § 706(2)(A). Under what we have called this “narrow” standard of review, we insist that an agency “examine the relevant data and articulate a satisfactory explanation for its action.” Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). We have made clear, however, that “a court is not to substitute its judgment for that of the agency,” ibid., and should “uphold a decision of less than ideal clarity if the agency’s path may reasonably *514 be discerned,” Bowman Transp., Inc. v. Arkansas–Best Freight System, Inc., 419 U.S. 281, 286, 95 S.Ct. 438, 42 L.Ed.2d 447 (1974).

In overturning the Commission’s judgment, the Court of Appeals here relied in part on Circuit precedent requiring a more substantial explanation for agency action that changes prior policy. The Second Circuit has interpreted the Administrative Procedure Act and our opinion in State Farm as requiring agencies to make clear “ ‘why the original reasons for adopting the [displaced] rule or policy are no longer dispositive’ ” as well as “ ‘why the new rule effectuates the statute as well as or better than the old rule.’ ” 489 F.3d, at 456–457 (quoting New York Council, Assn. of Civilian Technicians v. FLRA, 757 F.2d 502, 508 (C.A.2 1985); emphasis deleted). The Court of Appeals for the District of Columbia Circuit has similarly indicated that a court’s standard of review is “heightened somewhat” when an agency reverses course. NAACP v. FCC, 682 F.2d 993, 998 (1982).

We find no basis in the Administrative Procedure Act or in our opinions for a requirement that all agency change be subjected to more searching review. The Act mentions no such heightened standard. And our opinion in State Farm neither held nor implied that every agency action representing a policy change must be justified by reasons more substantial than those required to adopt a policy in the first instance. That case, which involved the rescission of a prior regulation, said only that such action requires “a reasoned analysis for the change beyond that which may be required when an agency does not act in the first instance.” 463 U.S., at 42, 103 S.Ct. 2856 (emphasis added).2 Treating failures to act and **1811 *515 rescissions of prior action differently for purposes of the standard of review makes good sense, and has basis in the text of the statute, which likewise treats the two separately. It instructs a reviewing court to “compel agency action unlawfully withheld or unreasonably delayed,” 5 U.S.C. § 706(1), and to “hold unlawful and set aside agency action, findings, and conclusions found to be [among other things] … arbitrary [or] capricious,” § 706(2)(A). The statute makes no distinction, however, between initial agency action and subsequent agency action undoing or revising that action.

To be sure, the requirement that an agency provide reasoned explanation for its action would ordinarily demand that it display awareness that it is changing position. An agency may not, for example, depart from a prior policy sub silentio or simply disregard rules that are still on the books. See United States v. Nixon, 418 U.S. 683, 696, 94 S.Ct. 3090, 41 L.Ed.2d 1039 (1974). And of course the agency must show that there are good reasons for the new policy. But it need not demonstrate to a court’s satisfaction that the reasons for the new policy are better than the reasons for the old one; it suffices that the new policy is permissible under the statute, that there are good reasons for it, and that the agency believes it to be better, which the conscious change of course adequately indicates. This means that the agency need not always provide a more detailed justification than what would suffice for a new policy created on a blank slate. Sometimes it must—when, for example, its new policy rests upon factual findings that contradict those which underlay its prior policy; or when its prior policy has engendered serious reliance interests that must be taken into account. Smiley v. Citibank (South Dakota), N. A., 517 U.S. 735, 742, 116 S.Ct. 1730, 135 L.Ed.2d 25 (1996). It would be arbitrary or capricious to ignore such matters. In such cases it is not *516 that further justification is demanded by the mere fact of policy change; but that a reasoned explanation is needed for disregarding facts and circumstances that underlay or were engendered by the prior policy.

 

EPA v. EME Homer City Generation, 572 U.S. 489, 542 n.5 (2014) (Scalia, J., dissenting)

EPA v EME Homer City Generation LP

5.  I am unimpressed, by the way, with the explanation that the majority accepts for EPA’s about-face: that the D.C. Circuit admonished it to “act with dispatch in amending or replacing CAIR.” Ante, at 1602 (citing North Carolina v. EPA, 550 F.3d 1176, 1178 (C.A.D.C.2008) (per curiam )). Courts of Appeals’ raised eyebrows and wagging fingers are not law, least so when they urge an agency to take ultra vires action. Nor can the encouragement to act illegally qualify as a “good reaso[n]” for an agency’s alteration of course under FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515, 129 S.Ct. 1800, 173 L.Ed.2d 738 (2009).

 

Perez v. Mortgage Bankers Ass’n, 575 U.S. 92, 101-03, 105-06 & n.5 (2015)

Perez v Mortgage Bankers Assn.doc

The straightforward reading of the APA we now adopt harmonizes with longstanding principles of our administrative law jurisprudence. Time and again, we have reiterated *102 that the APA “sets forth the full extent of judicial authority to review executive agency action for procedural correctness.” Fox Television Stations, Inc., 556 U.S., at 513, 129 S.Ct. 1800. Beyond the APA’s minimum requirements, courts lack authority “to impose upon [an] agency its own notion of which procedures are ‘best’ or most likely to further some vague, undefined public good.” Vermont Yankee, 435 U.S., at 549, 98 S.Ct. 1197. To do otherwise would violate “the very basic tenet of administrative law that agencies should be free to fashion their own rules of procedure.” Id., at 544, 98 S.Ct. 1197.

These foundational principles apply with equal force to the APA’s procedures for rulemaking. We explained in Vermont Yankee that § 4 of the Act “established the maximum procedural requirements which Congress was willing to have the courts impose upon agencies in conducting rulemaking procedures.” Id., at 524, 98 S.Ct. 1197. “Agencies are free to grant additional procedural rights in the exercise of their discretion, but reviewing courts are generally not free to impose them if the agencies have not chosen to grant them.” Ibid.


The Paralyzed Veterans doctrine creates just such a judge-made procedural right: the right to notice and an opportunity to comment when an agency changes its interpretation of one of the regulations it enforces. That requirement may be wise policy. Or it may not. Regardless, imposing such an obligation is the responsibility of Congress or the administrative agencies, not the courts. We trust that Congress weighed the costs and benefits of placing more rigorous procedural restrictions on the issuance of interpretive rules. See id., at 523, 98 S.Ct. 1197 (when Congress enacted the APA, it “settled long-continued and hard-fought contentions, and enact[ed] a formula upon which opposing social and political forces have come to rest” (internal quotation marks omitted)). In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules—whether or not they are consistent with earlier interpretations. That the D.C. Circuit would have struck the balance differently does not permit that court or *103 this one to overturn Congress’ contrary judgment. Cf. Law v. Siegel, 571 U.S. ––––, ––––, 134 S.Ct. 1188, 1197–1198, 188 L.Ed.2d 146 (2014).

* * *

In the main, MBA attempts to justify the Paralyzed Veterans doctrine on practical and policy grounds. MBA contends that the doctrine reinforces the APA’s goal of “procedural fairness” by preventing agencies from unilaterally and unexpectedly altering their interpretation of important regulations. Brief for Respondent 16.

There may be times when an agency’s decision to issue an interpretive rule, rather than a legislative rule, is driven primarily by a desire to skirt notice-and-comment provisions. But regulated entities are not without recourse in *106 such situations. Quite the opposite. The APA contains a variety of constraints on agency decisionmaking—the arbitrary and capricious standard being among the most notable. As we held in Fox Television Stations, and underscore again today, the APA requires an agency to provide more substantial justification when “its new policy rests upon factual findings that contradict those which underlay its prior policy; or when its prior policy has engendered serious reliance interests that must be taken into account. It would be arbitrary and capricious to ignore such matters.” 556 U.S., at 515, 129 S.Ct. 1800 (citation omitted); see also id., at 535, 129 S.Ct. 1800 (KENNEDY, J., concurring in part and concurring in judgment).

In addition, Congress is aware that agencies sometimes alter their views in ways that upset settled reliance interests. For that reason, Congress sometimes includes in the statutes it drafts safe-harbor provisions that shelter regulated entities from liability when they act in conformance with previous agency interpretations. The FLSA includes one such provision: As amended by the Portal–to–Portal Act of 1947, 29 U.S.C. § 251 et seq., the FLSA provides that “no employer shall be subject to any liability” for failing “to pay minimum wages or overtime compensation” if it demonstrates that the “act or omission complained of was in good faith in conformity with and in reliance on any written administrative regulation, order, ruling, approval, or interpretation” of the Administrator of the Department’s Wage and Hour Division, even when the guidance is later “modified or rescinded.” §§ 259(a), (b)(1). These safe harbors will often protect parties from liability when an agency adopts an interpretation that conflicts with its previous position.5

5  The United States acknowledged at argument that even in situations where a statute does not contain a safe-harbor provision similar to the one included in the FLSA, an agency’s ability to pursue enforcement actions against regulated entities for conduct in conformance with prior agency interpretations may be limited by principles of retroactivity. See Tr. of Oral Arg. 44–45. We have no occasion to consider how such principles might apply here.

 

Encino Motorcars, LLC v. Navarro, 136 S.Ct. 2117, 2125-26 (2016)

Encino Motorcars LLC v Navarro

One of the basic procedural requirements of administrative rulemaking is that an agency must give adequate reasons for its decisions. The agency “must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (internal quotation marks omitted). That requirement is satisfied when the agency’s explanation is clear enough that its “path may reasonably be discerned.” Bowman Transp., Inc. v. Arkansas–Best Freight System, Inc., 419 U.S. 281, 286, 95 S.Ct. 438, 42 L.Ed.2d 447 (1974). But where the agency has failed to provide even that minimal level of analysis, its action is arbitrary and capricious and so cannot carry the force of law. See 5 U.S.C. § 706(2)(A); State Farm, supra, at 42–43, 103 S.Ct. 2856.


Agencies are free to change their existing policies as long as they provide a reasoned explanation for the change. See, e.g., National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U.S. 967, 981–982, 125 S.Ct. 2688, 162 L.Ed.2d 820 (2005); Chevron, 467 U.S., at 863–864, 104 S.Ct. 2778. When an agency changes its existing position, it “need not always provide a more detailed justification than what would suffice for a new policy created on a blank slate.” FCC v. Fox Television Stations, *2126 Inc., 556 U.S. 502, 515, 129 S.Ct. 1800, 173 L.Ed.2d 738 (2009). But the agency must at least “display awareness that it is changing position” and “show that there are good reasons for the new policy.” Ibid. (emphasis deleted). In explaining its changed position, an agency must also be cognizant that longstanding policies may have “engendered serious reliance interests that must be taken into account.” Ibid.; see also Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735, 742, 116 S.Ct. 1730, 135 L.Ed.2d 25 (1996). “In such cases it is not that further justification is demanded by the mere fact of policy change; but that a reasoned explanation is needed for disregarding facts and circumstances that underlay or were engendered by the prior policy.” Fox Television Stations, supra, at 515–516, 129 S.Ct. 1800. It follows that an “[u]nexplained inconsistency” in agency policy is “a reason for holding an interpretation to be an arbitrary and capricious change from agency practice.” Brand X, supra, at 981, 125 S.Ct. 2688. An arbitrary and capricious regulation of this sort is itself unlawful and receives no Chevron deference. See Mead Corp., supra, at 227, 121 S.Ct. 2164.

 

Dep’t of Homeland Security v. Regents of the University of California, 140 S.Ct. 1891, 1913-15 (2020)

Department of Homeland Security v Regents of the University of California

The lead dissent acknowledges that forbearance and benefits are legally distinct and can be decoupled. Post, at 1929 – 1930, n. 14 (opinion of THOMAS, J). It contends, however, that we should not “dissect” agency action “piece by piece.” Post, at 1929. The dissent instead rests on the Attorney General’s legal determination—which considered only benefits—“to supply the ‘reasoned analysis’ ” to support rescission of both benefits and forbearance. Post, at 1930 (quoting State Farm, 463 U.S. at 42, 103 S.Ct. 2856 ). But State Farm teaches that when an agency rescinds a prior policy its reasoned analysis must consider the “alternative[s]” that are “within the ambit of the existing [policy].” Id., at 51, 103 S.Ct. 2856. Here forbearance was not simply “within the ambit of the existing [policy],” it was the centerpiece of the policy: DACA, after all, stands for “Deferred Action for Childhood Arrivals.” App. to Pet. for Cert. 111a (emphasis added). But the rescission memorandum contains no discussion of forbearance or the option of retaining forbearance without benefits. Duke “entirely failed to consider [that] important aspect of the problem.” State Farm, 463 U.S. at 43, 103 S.Ct. 2856.


That omission alone renders Acting Secretary Duke’s decision arbitrary and capricious. But it is not the only defect. Duke also failed to address whether there was “legitimate reliance” on the DACA Memorandum. Smiley v. Citibank (South Dakota), N. A., 517 U.S. 735, 742, 116 S.Ct. 1730, 135 L.Ed.2d 25 (1996). When an agency changes course, as DHS did here, it must “be cognizant that longstanding policies may have ‘engendered serious reliance interests that must be taken into account.’ ” Encino Motorcars, LLC v. Navarro, 579 U.S. ––––, ––––, 136 S.Ct. 2117, 2126, 195 L.Ed.2d 382 (2016) (quoting Fox Television, 556 U.S. at 515, 129 S.Ct. 1800). “It would be arbitrary and capricious to ignore such matters.” Id., at 515, 129 S.Ct. 1800. Yet that is what the Duke Memorandum did.

For its part, the Government does not contend that Duke considered potential reliance interests; it counters that she did not need to. In the Government’s view, shared by the lead dissent, DACA recipients have no “legally cognizable reliance interests” because the DACA Memorandum stated that the program “conferred no substantive rights” and provided benefits only in two-year increments. Reply Brief 16–17; App. to Pet. for Cert. 125a. See also post, at 1930 – 1931 (opinion of THOMAS, J). But neither the Government nor the lead dissent cites any legal authority establishing that such features automatically preclude reliance interests, and we are not aware of any. These disclaimers are surely pertinent in considering the strength of any reliance interests, but that consideration must be undertaken by the agency in the first instance, subject to *1914 normal APA review. There was no such consideration in the Duke Memorandum.

Respondents and their amici assert that there was much for DHS to consider. They stress that, since 2012, DACA recipients have “enrolled in degree programs, embarked on careers, started businesses, purchased homes, and even married and had children, all in reliance” on the DACA program. Brief for Respondent Regents of Univ. of California et al. in No. 18–587, p. 41 (Brief for Regents). The consequences of the rescission, respondents emphasize, would “radiate outward” to DACA recipients’ families, including their 200,000 U.S.-citizen children, to the schools where DACA recipients study and teach, and to the employers who have invested time and money in training them. See id., at 41–42; Brief for Respondent State of New York et al. in No. 18–589, p. 42 (Brief for New York). See also Brief for 143 Businesses as Amici Curiae 17 (estimating that hiring and training replacements would cost employers $6.3 billion). In addition, excluding DACA recipients from the lawful labor force may, they tell us, result in the loss of $215 billion in economic activity and an associated $60 billion in federal tax revenue over the next ten years. Brief for Regents 6. Meanwhile, States and local governments could lose $1.25 billion in tax revenue each year. Ibid.

These are certainly noteworthy concerns, but they are not necessarily dispositive. To the Government and lead dissent’s point, DHS could respond that reliance on forbearance and benefits was unjustified in light of the express limitations in the DACA Memorandum. Or it might conclude that reliance interests in benefits that it views as unlawful are entitled to no or diminished weight. And, even if DHS ultimately concludes that the reliance interests rank as serious, they are but one factor to consider. DHS may determine, in the particular context before it, that other interests and policy concerns outweigh any reliance interests. Making that difficult decision was the agency’s job, but the agency failed to do it.

DHS has considerable flexibility in carrying out its responsibility. The wind-down here is a good example of the kind of options available. Acting Secretary Duke authorized DHS to process two-year renewals for those DACA recipients whose benefits were set to expire within six months. But Duke’s consideration was solely for the purpose of assisting the agency in dealing with “administrative complexities.” App. to Pet. for Cert. 116a–118a. She should have considered whether she had similar flexibility in addressing any reliance interests of DACA recipients. The lead dissent contends that accommodating such interests would be “another exercise of unlawful power,” post, at 1930 (opinion of THOMAS, J.), but the Government does not make that argument and DHS has already extended benefits for purposes other than reliance, following consultation with the Office of the Attorney General. App. to Pet. for Cert. 116a.

Had Duke considered reliance interests, she might, for example, have considered a broader renewal period based on the need for DACA recipients to reorder their affairs. Alternatively, Duke might have considered more accommodating termination dates for recipients caught in the middle of a time-bounded commitment, to allow them to, say, graduate from their course of study, complete their military service, or finish a medical treatment regimen. Or she might have instructed immigration officials to give salient weight to any reliance interests engendered by DACA when exercising individualized enforcement discretion.

To be clear, DHS was not required to do any of this or to “consider all policy alternatives in reaching [its] decision.” *1915 State Farm, 463 U.S. at 51, 103 S.Ct. 2856. Agencies are not compelled to explore “every alternative device and thought conceivable by the mind of man.” Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc., 435 U.S. 519, 551, 98 S.Ct. 1197, 55 L.Ed.2d 460 (1978). But, because DHS was “not writing on a blank slate,” post, at 1929, n. 14 (opinion of THOMAS, J.), it was required to assess whether there were reliance interests, determine whether they were significant, and weigh any such interests against competing policy concerns.

The lead dissent sees all the foregoing differently. In its view, DACA is illegal, so any actions under DACA are themselves illegal. Such actions, it argues, must cease immediately and the APA should not be construed to impede that result. See post, at 1928 – 1930 (opinion of THOMAS, J.).
The dissent is correct that DACA was rescinded because of the Attorney General’s illegality determination. See post, at 1928. But nothing about that determination foreclosed or even addressed the options of retaining forbearance or accommodating particular reliance interests. Acting Secretary Duke should have considered those matters but did not. That failure was arbitrary and capricious in violation of the APA.