News & Analysis as of

Notice and Comment Department of Health and Human Services (HHS)

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Sheppard Mullin Richter & Hampton LLP

Fifth Circuit Upholds ACA Risk Adjustment Program

Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Bass, Berry & Sims PLC

The No Surprises Act Passed and (Surprise!) Healthcare Providers are Leery of its Impact

After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more

Foley & Lardner LLP

EUAs for LDTs no Longer Required, but at the Expense of PREP Act Immunity

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On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...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

Baker Donelson

District Court Ruling Impacts HIPAA Access Request Permissible Charges

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On January 23, 2020, the United States District Court for the District of Columbia declared sections of the 2013 Omnibus Rule unlawful. The Court found that the Department of Health and Human Services (HHS) impermissibly...more

Baker Donelson

HHS Memorandum Clarifies CMS Obligations Following Supreme Court Allina Decision

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In response to the disruptive Supreme Court decision on the impact and effect of administrative guidance, HHS has issued a memorandum suggesting that CMS's ability to enforce some of its payment policies may be limited by the...more

Morgan Lewis - Health Law Scan

HHS Analyzes Legal Impact of Allina on Agency Enforcement

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services...more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

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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

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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

District Court Refuses to Order HHS to Apply Pre-2004 Formula for DSH Payments Following Remand from Supreme Court

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On September 4, 2019, following remand from the Supreme Court’s decision in Azar v. Alina Health Services, No. 17-1484 (U.S. June 3, 2019), the United States District Court for the District of Columbia declined plaintiff...more

Polsinelli

Azar v. Allina Health Services: Hospitals Claim (Procedural) Victory in DSH Dispute

Polsinelli on

On June 3, 2019, the Supreme Court issued an eagerly anticipated opinion in Azar v. Allina Health Services, a decision with far-reaching implications both for the calculation of disproportionate share payments and provider...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

Davis Wright Tremaine LLP

Supreme Court Overturns Disproportionate Share Hospital Payment Policy and Limits CMS Use of Subregulatory Guidance

On June 3, 2019, the U.S. Supreme Court issued its decision in Azar v. Allina Health Services, et al., Case No. 17-1484. The Court ruled in favor of a group of hospitals in a dispute over Medicare disproportionate share...more

Arnall Golden Gregory LLP

Supreme Court Rules in Favor of Hospitals in HHS DSH Payment Dispute

On June 3, 2019, the Supreme Court of the United States (SCOTUS) issued an opinion in Azar v. Allina Health Services whereby it ruled that the United States Department of Health and Human Services (HHS) violated the Medicare...more

McGuireWoods Consulting

Supreme Court Rules HHS Cannot Take Short-Cuts in Rulemaking

In a 7-to-1 decision, the U.S. Supreme Court on June 3, 2019, held that “Because the Department of Health and Human Services neglected its statutory notice-and-comment obligations when it revealed a new policy that...more

Foley & Lardner LLP

What You Want to Know about the Supreme Court’s Recent Allina Decision

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In a landmark decision on June 3, 2019, the Supreme Court held that the Department of Health and Human Services (HHS) was required to engage in notice and comment rulemaking before publishing methodology (Medicare Fractions)...more

White and Williams LLP

Supreme Court Victory for Hospitals in Medicare Billing Dispute

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On June 3, 2019, the United States Supreme Court issued its decision in Azar v. Allina Health Services, delivering a multi-billion dollar victory for hospitals that serve a disproportionate share of low-income patients by...more

Hogan Lovells

U.S. Supreme Court ruling expands scope of Medicare notice-and-comment requirement

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On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive legal standard governing payment,...more

Sheppard Mullin Richter & Hampton LLP

SCOTUS Rejects CMS DSH Policy, Calls CMS Guidance Practices Into Question

Earlier this week, the Supreme Court upheld a D.C. Circuit Court decision vacating a policy of the Centers for Medicare and Medicaid Services (“CMS”) that would have “dramatically – and retroactively – reduced payments to...more

Verrill

U.S. Supreme Court Sides with Hospitals in Allina DSH Part C Days Decision

Verrill on

On June 3, 2019, the U.S. Supreme Court (“Court”) issued a 7-1 decision in Azar v. Allina Health Services, favoring hospitals that had sued the U.S. Department of Health and Human Services (“HHS”) over a Medicare payment...more

Robinson+Cole Health Law Diagnosis

Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals

In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share...more

King & Spalding

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

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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

Epstein Becker & Green

Supreme Court Expands the Scope of Public Participation in Medicare Policymaking

On June 3, 2019, the U.S. Supreme Court ruled in Azar v. Allina Health Services that the Medicare statute requires the Centers for Medicare & Medicaid Services (“CMS”) to engage in public notice-and-comment rulemaking...more

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