LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
Agency seeks industry comment on self-disclosure protocol to address issues and provide guidance to healthcare industry.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen McDermott, Arianne Callender, Howard Young, Eric Sitarchuk
The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe
The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay
The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Sha... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.
LawFlash/Client Alert | FDA and Healthcare LawFlash
Howard Young, Daniele Capasso, Albert Shay
Recently, in United States v. Borrasi ,[1] the Seventh Circuit aligned with the Third, Fifth, Ninth, and Tenth Circuits in determining that the Anti-Kickback Statute (AKS)more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe
The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender
The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more