Industry: Orthotics & Prosthetics/DME

PPSV has a track record of success in representing the interests of medical device manufacturers and distributors, arguably among the most highly regulated and negatively portrayed industries in modern health care. Our attorneys work with DME providers to overcome a multitude of challenges resulting from their severely restrictive environment. 

We have significant experience with all federal and state regulations and statutes, and their implications to DME clients, including: the Medical Device Amendment (1976); the Federal Food Drug and Cosmetic Acts (1990, 1992); and the Medicare Modernization Act (2003), as well as OIG Guidances and directives.

PPSV provides counseling on pricing issues; evaluates payment and reimbursement coverage; distills outcomes data for possible use in securing reimbursement; analyzes marketing initiatives for possible Fraud and Abuse implications; advises on FDA reporting obligations vis-à-vis potential False Claims Act liability; and develops compliance policies and procedures.  If warranted, our attorneys develop and implement powerful litigation strategies in defense of clients, including in Department of Justice qui tam actions.

In addition, our attorneys work within the firm’s established sphere of influence to act as industry advocates, help to affect needed regulatory changes in existing laws, and to solve problems at the state and national levels.