Healthcare

Whether you are new to the industry or a well established player, HPM’s attorneys can help you navigate all aspects of the healthcare regulatory playing field.  We can tackle your questions and issues related to working with health regulatory bodies including, FDA, HHS, CMS, OCR, and state regulatory bodies.

Fraud and Abuse

HPM’s attorneys can help you understand the laws and regulations that affect the relationships between manufacturers, health care providers, pharmacy benefit managers, distributors, pharmacies, group purchasing organizations, and patients.  Our attorneys have extensive experience advising on and navigating compliance with:

• The Federal Health Care antikickback law and related federal and state laws and regulations
• The Federal False Claims Act and related federal and state laws and regulations
• The Federal Self-Referral Law (Stark Law) and related federal and state laws and regulations
• Federal transparency reporting requirements (Sunshine Act) and related regulations
• 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

HPM’s attorneys routinely conduct compliance audits and help in the development of effective compliance programs.  We also assist in developing contracting strategies for entities throughout the distribution chain and represent companies and individuals in enforcement actions brought under these laws.

Government Pricing, Price Reporting and Contracting

HPM’s attorneys have deep knowledge of the requirements for drug and device manufacturers working with the government.

We assist pharmaceutical companies in Medicaid Drug Rebate Program matters, including regularly advising companies on compliance with Rebate Program requirements.  HPM has successfully negotiated with CMS to resolve issues relating to the calculation of best price, average manufacturer price, and other issues. We also guide companies in complying with and resolving issues under state pharmaceutical rebate programs; the 340B Drug Discount Program; the Medicare Part D coverage gap discount program; and the average sales price reporting requirements under Medicare Part B. HPM’s attorneys help drug manufacturers evaluate the implications of their commercial pricing, including value-based pricing on government programs.

We also represent drug and device companies in matters relating to contracting with the federal government, including:

• Negotiation of Federal Supply Schedule (FSS) contracts with the Department of Veterans Affairs
• 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
• Price Reduction Clause and other contractual and statutory requirements
• Department of Veterans Affairs audits
• Calculation and payment of refunds under the TRICARE retail pharmacy refund program

We also help drug manufacturers comply with ever-increasing state requirements for reporting on prices and price increases.

HIPAA Privacy and Security Standards

HPM’s attorneys understand the value and importance of protecting patient information and other sensitive data.  We routinely assist health care companies on matters relating to the HIPAA Privacy Standards and state medical information privacy laws.  We provide practical advice for compliance to companies designing clinical research, marketing, patient assistance, and other programs.  We assist in the review and drafting of related authorizations, consents, business associate agreements, and other documents.