Lynn Shapiro Snyder, Benjamin Martin, and Robert Wanerman, attorneys in the Health Care and Life Sciences practice, in the Washington, DC, office, have coauthored a chapter in the Pharmaceutical and Medical Device Compliance Manual, titled “Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices.”
The Pharmaceutical and Medical Device Compliance Manual is a joint publication of the Food and Drug Law Institute, the American Health Lawyers Association, and the Center for Health & Pharmaceutical Law & Policy at Seton Hall University School of Law.
The manual offers an in-depth overview of the federal and state enforcement agencies that are responsible for investigating and resolving violations of the law by health care entities, with an emphasis on pharmaceutical and medical device companies.
Other topics include federal Anti-Kickback Statute and False Claims Act details; the distinction between manufacturers’ lawful dissemination of scientific information and unlawful promotion of off-label use; a discussion of the Foreign Corrupt Practices Act and its extra-territorial reach; and prescription drug price regulations.
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