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A Pathway for Medicare Coverage for Breakthrough Devices: Take Two

On June 27, 2023, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a “Notice with Comment Period” (“Notice”) describing a new process for providing expedited Medicare coverage for certain eligible...more

DOJ Increases Scrutiny of Arrangements with EHR Vendors: What the ModMed Settlement Means for the Life Sciences Industry

On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more

Federal Judge Reinstates Georgia Section 1115 Waiver

On August 19, 2022, the United States District Court for the Southern District of Georgia reinstated “Georgia Pathways,” a Section 1115 demonstration waiver which requires individuals, among other conditions, to complete 80...more

Departments Issue Final No Surprises Act Dispute Resolution Rule and Other Guidance

On August 19, 2022, the Departments of Health and Human Services, Labor, and the Treasury (the Departments) issued a long-awaited final rule (the Final Rule) on the Independent Dispute Resolution (IDR) Process under the No...more

Senate Deal Includes Drug Pricing Reform and Extension of ACA Subsidies

On Wednesday July 27, 2022, Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) reached a deal on The Inflation Reduction Act of 2022, which proposes to raise $739 billion in revenue to be invested in...more

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