Pharmaceutical Compliance
McKenna Long & Aldridge has one of the broadest, most experienced practices in the area of public health procurement, federal health care programs, biodefense and the marketing and sales practices of pharmaceutical companies, biotechs and medical suppliers. Our practice focuses on the laws and regulations affecting the types of relationships with the federal government.
Medicare Contracting and Government Procurement
McKenna Long & Aldridge attorneys and policy experts have extensive experience in handling all aspects of special contracts issues arising under contracts with the Department of Health and Human Services’, Centers for Medicare and Medicaid Services (CMS). We have a long history of counseling clients who perform as Carriers and Intermediaries in support of CMS' federal Medicare Part A and Part B, Durable Medical Equipment, Program Safeguard and other federally-funded health care programs and contract requirements, clients who compete for and perform contracts to provide similar services in connection with the Tricare and Federal Employee Health Benefit (FEHB) health care programs, and clients who contract with state Medicaid agencies.
MLA counsels a number of companies concerned with the statutorily required transition from CMS' traditional "Title XVIII" contracting practices to practices compliant with the Cost Accounting Standards (CAS) and the Federal Acquisition Regulation (FAR). We also counsel companies concerning CMS' consolidation of its traditional contracts into bundled services contracts known as Medicare Administrative Contracts.
MLA routinely assists companies establishing a relationship and familiarizing themselves with CMS. In the current dynamic contracting environment, we help companies enter into Medicare and other federally-funded health care program contracts. In addition, we help our "incumbent" CMS contractor clients to adjust to the CMS' transition to FAR/CAS-based government contracts. Further, we support companies in their efforts to recover termination costs after the severance of their contract relationship(s) with the CMS.
Our experience includes:
- Counseling new entrants in the Medicare and federally-funded health care industry on unique government contracting practices, subject matter, terms and procurement protest matters
- Conducting risk assessment of multi-site Medicare intermediaries
- Conducting compliance reviews and internal investigations
- Working with incumbent Medicare and federally-funded health care contractors on adjusting their business practices to comply with the requirements of the CAS and the FAR
- Assisting clients with difficult cost accounting and other audit issues with the government agency
- Resolving client cost and contract performance issues with the government agency, including requests for equitable adjustments, claims and disputes under their contracts
- Maximizing termination cost recovery upon the termination of traditional Medicare and federally-funded health care contracts, and represent contractors in cost recovery proceedings
- Representing companies in payment and contract dispute resolution and protests of contract solicitations and awards
Pharmaceutical and Medical Supplier Public Sector Business
The Public Health and Pharmaceutical Compliance practice group provides a wide variety of services to clients that supply pharmaceuticals and medical devices to the federal government and its beneficiaries under federally funded health care programs.
Our experience in this area includes:
- Formulating and delivering training programs for employees of the pharmaceutical and medical industries involved in public sector sales
- Counseling companies regarding compliance with Medicaid OBRA 90 and the Veterans Health Care Act
- Conducting Medicaid, the Veterans Health Care Act (VHCA) and Federal Supply Service (FSS) diagnostic audits and developing customized Standard Operating Procedures to ensure integrity of reported pricing
- Performing corporate governance audits and assists companies’ implement compliance programs that satisfy the requirements of the State of California
- Assisting companies undergoing inspector general audits
- Training and counseling companies on appropriate gifts, grants and conflicts of interests and compliance with the Anti-kickback Act
- Representing companies in connection with efforts to obtain research and development and production contracts, contract disputes, and protests of contract solicitations and awards
Our practice involves agencies such as the Department of Health and Human Services (HHS), the Department of Defense (DOD) and the Department of Veterans Affairs (VA) in procurement related litigation and False Claims Act prosecutions in the Federal District Courts. Beginning in 1993 -- after passage of the Veterans Health Care Act -- MLA began conducting compliance audits for pharmaceutical companies relating to their VA, DOD and PHS pricing and now have consulted with over forty pharmaceuticals on their compliance initiatives relating to public sector business.
We are counsel to the Coalition for Federal Procurement, which has twenty-five pharmaceutical member companies with interests in VA and DOD pharmaceutical pricing. Our lead lawyers attend the Coalition's monthly meetings to assist it in forming an appropriate agenda of issues for the Coalition to take up with the Under Secretary's of Health at DOD and VA and advising the Coalition on legal issues of common interest to the member pharmaceutical companies.
Our lawyers are active members of the American Bar Association's Health Care Contracting Committee where we coordinate an annual program on public sector pharmaceutical pricing and serve in leadership capacities.
Advisories
- November 9, 2012
- November 2, 2012
- November 2, 2012