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Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more

Trending in 2024: What Does the HCFAC Report Signal About Federal Enforcement Mechanisms?

The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS...more

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

November Fast Break Recap: Compliance Topics for Healthcare Professionals Interacting with Pharma/Device Manufacturers

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more

HHS Last-Minute Final Rule Restricts Use of Guidance Standards in Civil Enforcement Actions

The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for...more

HHS to Exercise Enforcement Discretion in Response to CMS Telehealth Waiver

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the...more

CMS Issues Program Instructions for Medicare Telehealth Waiver

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the...more

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