Representative Experience

Have been involved in drafting many important pieces of health legislation over the past decade, including 1997 Food and Drug Administration Modernization Act, Orphan Drug Act, Health Insurance Portability and Accountability Act of 1996 and other comprehensive healthcare reform legislation, and legislation involving specific changes to Medicare and Medicaid law

Legislative Representation:  Represented leading pharmaceutical and biotech companies in connection with the Medicare Prescription Drug, Improvement and Modernization Act of 2003. We now advise companies on implementation of the act.

Healthcare Compliance and Investigations

Represented an individual who was the target of a federal grand jury investigation. The matter involved allegations that he and his company paid illegal kickbacks to physicians to encourage the purchase of kidney dialysis supplies. We successfully prevented charges from being brought against him.

Healthcare Compliance and Investigations

Drafted the compliance policies of a physician practice at a major teaching hospital and advised that practice on the establishment of its compliance program

Healthcare Compliance and Investigations

Represented physician groups under investigation as part of the Office of Inspector General’s national Physicians at Teaching Hospitals (“PATH”) audit initiative

Healthcare Compliance and Investigations

On behalf of our client, we made the first voluntary disclosure of Medicare over-billing in New England under the Office of Inspector General’s voluntary disclosure protocol. We negotiated the related settlement agreement, as well as an innovative corporate integrity agreement. As a result, we avoided lengthy litigation that could have led to our client being barred from participation in the Medicare program.

Legislative Representation

In connection with the reauthorization of the Prescription Drug User Fee Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act, we represented several leading pharmaceutical and biotechnology companies and industry trade associations

Legislative Representation

Involved in the reauthorization of pediatric drug exclusivity provisions. These provisions require drug companies to perform pediatric testing and labeling on new products, but they also grant manufacturers a six-month patent extension for pediatric labeling.

Legislative Representation

Involved in legislation relating to competitive bidding for certain durable medical equipment

Legislative Representation

Involved in issues related to “Hatch-Waxman” patent term issues

Legislative Representation

Represented companies under the Orphan Drug Act. This act is credited with giving rise to the biotech industry through its provision of seven years of marketing exclusivity to the companies that develop drugs or biologics for patients with rare diseases

Legislative Representation

Represented clients on issues related to drug pricing and reform of the Average Wholesale Price (AWP) for drugs