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McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Bass, Berry & Sims PLC

CMS & HHS Withdraw Appeal to Recent Copay Accumulator Federal District Court Decision: 2020 Accumulator Rule Still in Effect

On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV and Hepatitis Policy Institute et...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

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Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

McDermott Will & Emery

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

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After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

Bass, Berry & Sims PLC

The ABCs of Medicare and Medicaid Claims Audits: Responding to Audits and Potential Consequences from Negative Audits

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As addressed in the first installment of this three-part series, healthcare providers face potential audits from an increasing number of Medicare and Medicaid contractors. Failing to respond properly can lead to significant...more

McDermott Will & Emery

McDermott’s Healthcare Enforcement Quarterly - Q1 2022

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The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny,...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

McDermott Will & Emery

Pending Supreme Court Decision in AHA v. Becerra May Be Felt Well Beyond the Healthcare Industry

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By July 2022, the US Supreme Court is expected to release its opinion in American Hospital Association v. Becerra, a case that not only has significant ramifications for healthcare providers but may also impacts the deference...more

King & Spalding

Court of Appeals Affirms Ruling that Hospital Utilization Review Committee’s Medicare Part A Inpatient Reclassifications Trigger...

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On January 25, 2022, the U.S. Court of Appeals for the Second Circuit affirmed a lower court ruling that the Secretary of HHS violated the due process rights of Medicare beneficiaries by failing to provide an administrative...more

Holland & Knight LLP

Price Transparency in Hospitals – Is Hospital Pricing Data a Protected Trade Secret?

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By this point, it's no secret the cost of healthcare services can vary dramatically between different providers of the same services. The Bush, Obama, Trump and Biden administrations all pushed for price transparency in...more

Sheppard Mullin Richter & Hampton LLP

Site-Neutral Payments Stand: SCOTUS Declines to Hear AHA Appeal, Preserving Lower Payments to Off-Campus Provider-Based...

In July 2020, we discussed a ruling by the D.C. Court of Appeals upholding the Department of Health and Human Services’ (HHS) site-neutral payment rules. On Monday, June 28, 2021, the Supreme Court declined, without comment,...more

McDermott Will & Emery

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more

Foley Hoag LLP - Medicaid and the Law

The Avon Nursing Case: A Lesson in Challenging Medicaid Rulemaking for Providers

Medicaid providers seeking to directly challenge HHS rulemaking recently found success in the 2nd Circuit. In the recent case of Avon Nursing & Rehab v. Becerra, the court sided with a skilled nursing home provider bringing a...more

King & Spalding

U.S. Supreme Court Removes Oral Arguments Over State Medicaid Work Requirements from Calendar

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On Thursday, March 11, 2021, the U.S. Supreme Court announced that it will no longer hear oral arguments that were set to occur on March 2, 2021, over D.C. Circuit Court of Appeals rulings striking down Medicaid work...more

Baker Donelson

Federal Appeals Court Upholds Payment Reduction to 340B Hospitals

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On July 31, 2020, the D.C. Circuit Court of Appeals issued a decision reversing a lower court decision and upholding Medicare payment cuts to certain hospitals participating in the 340B drug pricing program that have been in...more

King & Spalding

Hospital Associations Appeal Decision Upholding Price Transparency Rule; King & Spalding Price Transparency Working Group Helping...

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On July 17, 2020, the American Hospital Association and several additional associations and individual hospitals filed their opening brief in their appeal of a decision of the district court, which, had upheld CMS’s price...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

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Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Foley Hoag LLP - Medicaid and the Law

Washington D.C. Appellate Court Upholds Prohibition on Medicaid Work Requirement Waivers

The Centers for Medicare & Medicaid Services (CMS) suffered a big loss in court last week. The United States Court of Appeals for the D.C. Circuit upheld a lower court ruling that blocked CMS from implementing one of the...more

Mitchell, Williams, Selig, Gates & Woodyard,...

State Hospital Association Fights Changes to Medicaid DSH Payment Rules

For hospitals that “serve a disproportionate number of indigent patients” Medicaid allows for supplemental payments to help ensure their financial viability. The calculation of those supplemental payments recently became the...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

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In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

King & Spalding

District Court Order Paves Way for HHS to Appeal Decision Finding 340B Rate Cut Unlawful Without First Providing a Proposed Remedy...

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On July 10, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted HHS’ request for a final judgment, clearing the way for the government to immediately appeal his earlier decision that...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

Foley & Lardner LLP

340B Rate Cuts: DC Court Enjoins and Remands CMS’ 2018 and 2019 Reductions for Hospital Outpatients

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On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more

Baker Donelson

Government Appeals Decision Declaring 340B Payment Cuts Unlawful; District Court Continues to Consider Question of Relief

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The U.S. government has appealed a federal district court decision issued in December 2018 that found the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain...more

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