News & Analysis as of

Notice and Comment Medicare

Holland & Knight LLP

CMS Proposes Transitional Coverage for Emerging Technologies

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The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...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

K&L Gates LLP

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

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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

CMS Advances 340B Drug Acquisition Cost Survey to OMB and Solicits Final Comments Directly to OMB

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On February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more

Baker Donelson

The Nightmare Came True: Minor Licensing Actions Could Lead to Disastrous Collateral Damages

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As forewarned, CMS's finalization of the Calendar Year (CY) 2020 Physician Fee Schedule, effective January 1, 2020, brings significant changes to its authority to deny or revoke a Medicare enrollment for physicians and other...more

Baker Donelson

Azar v. Allina Health Services: Making Waves in Medicare Claim Appeals?

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When ruling that notice-and-comment procedures may be required for Medicare guidance, the Supreme Court may not have foreseen the potential disruptive impact on Medicare coverage rules....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

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 28, Number 42. News Briefs: November 2019 #4

Report on Medicare Compliance 28, no. 42 (November 25, 2019) - In a surprising CMS memo that just surfaced, top CMS attorneys echo the sentiments of the Department of Justice about the limits of enforcement actions based...more

Baker Donelson

D.C. District Court Issues Two Decisions Addressing CMS's Medicare Bad Debt "Must Bill" Policy – One Rejecting the Policy and the...

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In a significant break from preceding court decisions, the United States District Court for the District of Columbia recently struck down CMS's "must bill" policy, which requires that Medicare providers bill Medicaid and...more

King & Spalding

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

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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

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

King & Spalding

District Court Rules that Supreme Court’s Allina Decision Requires Notice-and-Comment Rulemaking for CMS’s Long-Term Care Hospital...

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On August 22, 2019, the United States District Court for the District of Columbia held that CMS had unlawfully changed its “must-bill” policy, without going through notice-and-comment rulemaking, when it denied bad-debt...more

Polsinelli

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

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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

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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

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