News & Analysis as of

Medicare Medical Devices Health Insurance

Benesch

Dialysis & Nephrology Digest - October 2024

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The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations

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Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations - On September 6, the US Attorney’s Office for the District of Maryland announced that THD America, Inc., and its parent company, THD SpA of Italy,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #2

News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more

McDermott+

CMS Releases Final TCET Notice – Implications and Next Steps

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Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #1

News Briefs - Texas Federal Court Ruling Puts Noncompete Ban on Hold - A Texas federal court issued a preliminary injunction against the Federal Trade Commission's noncompete ban, which if implemented would allow existing...more

Alston & Bird

Health Care Week in Review: Senate Democrats Released Draft Legislation to Prevent Labor and Delivery Unit Closures; CMS Announced...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

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Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott+

McDermottPlus Check-Up: January 5, 2024

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Congress Returns Next Week to Face Imminent Funding Deadlines. The Senate will return to session on January 8, and the House will return on January 9. Lawmakers face an immediate time crunch on FY 2024 appropriations, as the...more

Epstein Becker & Green

Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating...

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When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more

Pullman & Comley - Connecticut Health Law

Significant 2022 Connecticut Health Law Cases

Significant health care cases of 2022 included a surprise billing unfair trade practices case, a class action recognizing a patient’s constitutionally protected interest in their inpatient classification and a ruling...more

McDermott Will & Emery

Remote Monitoring Services Under Review: Medicare Coverage Policies May Be Coming

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Six of the seven Medicare Administrative Contractors (MACs) are scheduled to jointly host a multijurisdictional contractor advisory committee (CAC) meeting on February 28, 2023. This CAC panel meeting will allow the MACs to...more

Hogan Lovells

Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

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On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of Innovative Technology (MCIT) and...more

Mintz - Health Care Viewpoints

CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices

The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2020 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes to Streamline Medicare Coverage Process for Innovative Technology and Consider Commercial Coverage in “Reasonable and...

- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more

Hogan Lovells

CMS proposes “reasonable and necessary” definition, expedited breakthrough device coverage process

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On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

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In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

BakerHostetler

Capitol Hill Healthcare Update

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House Majority Leader Kevin McCarthy (R-Calif.) said lawmakers will vote this week on legislation to renew federal funding for the Children’s Health Insurance Program (CHIP), even amid unresolved partisan disagreements over...more

BakerHostetler

Capitol Hill Healthcare Update

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Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...more

Proskauer Rose LLP

The ERISA Litigation Newsletter - December 2016

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This month Richard Zall, Chair of Proskauer's Health Care Department, explores developments likely to occur with respect to the Affordable Care Act as a result of the new administration. In our Rulings, Filings and...more

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