News & Analysis as of

Administrative Procedure Act Rulemaking Process Medicare

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Alston & Bird

Trump Administration Changes Seek to Avoid Notice and Comment Hurdles

Alston & Bird on

Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more

Womble Bond Dickinson

The Biden Administration Expands Staff Vaccination Requirement to All Medicare & Medicaid Participating Providers/Suppliers.

Womble Bond Dickinson on

The Biden Administration, through the Centers for Medicare and Medicaid Services (“CMS”) and via Interim Final Rulemaking (“IFR”), has expanded vaccination requirements in many health care settings. Effective November 5,...more

Wiley Rein LLP

Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?

Wiley Rein LLP on

In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more

Wiley Rein LLP

Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?

Wiley Rein LLP on

In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

K&L Gates LLP on

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

McDermott Will & Emery

Healthcare Enforcement Quarterly Roundup - Q4 2019

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

Polsinelli

CMS Outlines New Standard for Challenging Medicare Payment Denials, Echoing Brand Memo on Force of Sub-Regulatory Guidance

Polsinelli on

On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more

King & Spalding

President Trump Issues Executive Order Limiting Agency Use of Informal Guidance Documents

King & Spalding on

On October 9, 2019, President Trump issued an Executive Order aimed to curb agencies, such as CMS, from using informal guidance documents as de facto rules that have the binding effect of law. In a press conference...more

Brownstein Hyatt Farber Schreck

Medicare Rulemaking After Azar v. Allina Health Services

The Medicare Program, established in 1965, initially seemed simple: provide health care for senior citizens by paying hospitals and doctors directly for the care the seniors required. Initially, there were two parts to...more

King & Spalding

Supreme Court Delivers Victory to Providers in Allina DSH Part C Case in a Decision with Broad Implications

King & Spalding on

In a major win for providers that serve a disproportionate share of indigent patients, the Supreme Court today upheld the D.C. Circuit’s earlier decision invalidating CMS’s policy to treat beneficiaries enrolled in Part C...more

Mintz - Health Care Viewpoints

Update on Azar v. Allina Health Services: Supreme Court Hears Oral Argument on When CMS Must Use Formal Rulemaking

On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more

Mintz - Health Care Viewpoints

Supreme Court to Decide Critical Case on When CMS Must Use Formal Rulemaking when Instructing Medicare Contractors

On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more

Baker Donelson

Supreme Court Grants Review in Allina Health Services Case

Baker Donelson on

Is the Department of Health and Human Services (HHS or the government) required to engage in notice and comment rulemaking when it changes a requirement that has an important impact on hospitals' reimbursement? As we reported...more

Epstein Becker & Green

Reimbursement Issues Worth Noting: Administrative Law and False Claims Act Implications

Epstein Becker & Green on

News of two distantly related reimbursement issues with administrative law and False Claims Act (“FCA”) implications is worth noting....more

McDermott Will & Emery

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Emery on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

Baker Donelson

Uncertainty Continues for Two-Midnight Rule's Payment Reduction

Baker Donelson on

In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more

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