Chapter 6, “Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices”

Pharmaceutical and Medical Device Compliance Manual (Second Edition) September 2019

Robert E. Wanerman and Constance A. Wilkinson, Members of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices," a chapter in the Pharmaceutical and Medical Device Compliance Manual, published by the American Health Lawyers Association (AHLA) and Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy.

A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today’s complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government’s expectations of an effective compliance program and ethical business practices, as well as:

  • how the government discovers potential enforcement actions,
  • its approach to pursuing such actions,
  • what behaviors can constitute mitigating factors for a company in the event of a legal violation.

Coverage includes new chapters covering:

  • Pharmaceutical industry interactions with patient organizations
  • Compliance 2.0: compliance analytics in the era of big data
  • The art and science of health care compliance in the pharmaceutical and medical device industries

The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.

For more information about the book and to order, please visit Store.LexisNexis.com.