Commercial Products and Services
Compliance and Voluntary Disclosure
Foreign Sales/International Government Contracts
Government Finance & Privatization
Military Bases and Communities
Defensive Measures and Emergency Preparedness
Public Policy and Legislative Action
Public Health and Pharmaceutical Compliance
Radio Frequency Identification (RFID)
State and Local Government Contracts
Teaming Agreements and Subcontracts
Intellectual Property and Technology
Market Research and Contracting Opportunities
Our Public Health Preparedness team, comprised of public policy advisors, PhDs and procurement attorneys, tracks all appropriations and related procurement developments by the National Institutes of Health, Centers for Disease Control, Department of Health and Human Services, Department of Homeland Security, and Department of Defense and various EU agencies. In addition to assessing publicly announced solicitations, the team also targets specific agency organizational elements where unsolicited proposals (what industry thinks the government needs) will be most favored and accepted. We strategize and oversee the preparation of such unsolicited proposals, as well as responses to Requests for Information (RFIs) and Requests for Proposals (RFPs).
Bidding Advice and Bid Preparation
Our team develops procurement opportunities for our clients by helping federal agencies shape their requirements. We provide bidding advice and, through our strategic alliances, guide the actual proposal preparation process, including reading team reviews through submission to ensure responsiveness to government requirements. We are experienced in negotiating favorable contract terms and in bringing bid protests to successful conclusions on behalf of our clients.
Medicare Contracting and Government Procurement
We have extensive experience in handling all aspects of special contracts issues arising under contracts with HHS and the 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's federal Medicare Part A and Part B, Durable Medical Equipment, Program Safeguard and other federally-funded healthcare programs and contract requirements. We also work with clients who compete for and perform contracts to provide similar services in connection with the Tricare and Federal Employee Health Benefit (FEHB) healthcare programs and clients who contract with state Medicaid agencies.
We currently counsel a number of companies concerned with the statutorily required transition from the traditional “CMS ‘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's consolidation of its traditional contracts into bundled services contracts known as Medicare Administrative Contracts.
We routinely assist companies that are establishing a relationship and familiarizing themselves with CMS. In the current dynamic contracting environment, we help companies enter into Medicare and other federally-funded healthcare 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 CMS.
Procurement and Compliance Training
We host a series of training programs for the pharmaceutical, biotech, diagnostic, manufacturing and construction industries. These programs have been conducted at more than two dozen major pharmaceutical and biotech companies.
Pharmaceutical and Medical Supplier Public Sector Business
The Public Health and Pharmaceutical Compliance team provides a wide variety of services to clients who supply pharmaceuticals and medical devices to the federal government and its beneficiaries under federally funded health-care programs.
Our practice involves departments such as HHS, DOD and Veteran's Affairs (VA) in procurement-related litigation and False Claims Act prosecutions in the federal district courts. Beginning in 1993, after the passage of the Veteran's Health Care Act, the team initiated compliance audits for pharmaceutical companies relating to their VA, DOD and Public Health Service pricing and to date, have consulted with more than 40 pharmaceuticals on compliance initiatives relating to public sector business.
We are counsel to the Coalition for Federal Procurement, consisting of 25 pharmaceutical companies with interests in VA and DOD pharmaceutical pricing. Our lead attorneys attend the Coalition's monthly meetings to assist in forming an appropriate agenda of issues for it to present to the under secretaries of Health at DOD and VA, as well as to advise the Coalition on legal issues of common interest to the member pharmaceutical companies.
Legal Solutions and Cost Accounting
Particularly in the emerging field of public health preparedness, it is important to understand and use the legal tools available to companies wishing to minimize risk while contracting profitably with the government. With the original and largest government contracts law practice in the United States, we bring to bear the full range of opportunities for our clients.
Our Public Health Preparedness team was at the forefront of developing the Project BioShield legislation and the Pandemic and All-Hazards Preparedness Act, an add-on to Project Bioshield. We understand other contractual vehicles that companies can use to their benefit. Once contract performance begins, we aid in structuring efforts related to the accounting, finance and contract administration for peak performance and profitability. We build out the compliance functions based on our extensive knowledge of the FAR, CAS, and Cost Ethics Rules.