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HHS Regulatory Sprint takes final shape, Part 2: AKS, Stark regulatory revisions for value-based care

USA - December 1 2020 Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final...

David E. Thiess, Laura E. Hunter, Ron Wisor, Jonathan Diesenhaus, Helen R. Trilling.

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

USA - November 24 2020 On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019...

David E. Thiess, Melissa K. Bianchi, Maria Malas, Mahmud Brifkani, Ron Wisor, Eliza L. Andonova, Helen R. Trilling.

HHS OIG has “significant concerns” about company-sponsored speaker programs

USA - November 18 2020 On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert - a type of guidance...

David E. Thiess, Laura E. Hunter, Maria Malas, Ron Wisor, Eliza L. Andonova, Helen R. Trilling.

OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

USA - September 23 2020 On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a...

Laura E. Hunter, Ron Wisor, Eliza L. Andonova.

Expanded access to telehealth services during the COVID-19 pandemic

USA - April 2 2020 In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state...

Ken Choe, Brooke Bumpers, Craig Smith.