Hyman Phelps and McNamara
 
Health Care
 
HPM's familiarity with the drug and device industries makes the firm particularly well-equipped to assist manufacturers in understanding how health care laws and regulations, such as those relating to fraud and abuse, pricing, and coverage and reimbursement, affect the marketing of drugs and devices. The firm's health care practice includes the following areas.

Health Care Fraud and Abuse Laws

HPM advises on compliance with Medicare and Medicaid laws and other health care laws that affect financial and incentive arrangements among various constituents, including manufacturers, health care providers, pharmacy benefit managers, distributors, group purchasing organizations, and patients. We assist clients with issues relating to:
  • The Federal health care program antikickback law and related federal and state laws

  • The Federal False Claims Act and related federal and state laws
  • Federal transparency reporting requirements
  • State drug and device marketing prohibitions and reporting laws
  • State consumer protection laws
  • State professional licensing laws
  • Other state laws applicable to drug and device marketing activities
We also conduct compliance audits; help in the development of compliance programs; assist in developing contract strategies with respect to commercial customers and other entities in the distribution chain; and represent companies and individuals in enforcement actions brought under these laws.

Government Price Reporting and Discount Requirements

The firm assists pharmaceutical companies in matters arising under the Medicaid Drug Rebate Program. We regularly advise companies on compliance with Rebate Program requirements, and we have successfully negotiated with CMS to resolve issues relating to the calculation of best price, average manufacturer price, and other issues. Similarly, we assist companies in complying with and resolving issues under state pharmaceutical rebate programs; the Public Health Service Drug Pricing Program established under section 340B of the Public Health Service Act; the Medicare Part D coverage gap discount program; and the average sales price reporting requirements under Medicare Part B. We also help drug manufacturers in evaluating the implications of their commercial pricing on these government programs.

Federal Government Contracting

We represent drug and device companies in matters relating to contracts with the federal government, including:
  • Negotiation and completion of Federal Supply Schedule (FSS) contracts with the Department of Veterans Affairs (DVA)
  • Reporting of Non-Federal Average Manufacturer Price and compliance with Federal ceiling price restrictions under section 603 of the Veterans Health Care Act of 1992 (for pharmaceuticals)
  • Price Reduction Clause and other contractual and statutory requirements
  • DVA audits

  • Calculation and payment of refunds under the TRICARE retail pharmacy refund program
HIPAA Privacy and Security Standards and State Medical Information Privacy Laws

The firm routinely assists pharmaceutical, medical device, and e-commerce health care companies on matters relating to the HIPAA Privacy Standards and state medical information privacy laws. We help companies design their clinical research, marketing, patient assistance, and other programs in a manner that complies with these authorities. We assist in the review and drafting of related authorizations, consents, business associate agreements, and other documents.


Primary Contacts:

Fraud and Abuse Compliance

Alan Kirschenbaum

Jeffrey Wasserstein

Michelle Butler

Government Contracting and Pricing

Alan Kirschenbaum

Michelle Butler

HIPAA

Jeffrey Wasserstein

Alan Kirschenbaum



Firm Publications