Helping our clients navigate governmental, regulatory and administrative matters
Foley Hoag has a long history of extensive involvement with the development of legislation and regulations affecting the biotechnology, pharmaceutical, medical device and healthcare provider industries. Our clients include a number of leading pharmaceutical, biotechnology and medical device companies regarding government strategies for legislative, regulatory and administrative matters.
Medicare Coverage and Payment
Medicare and Medicaid finance nearly one-half of the nation's health expenditures, and Medicare policy decisions have great impact on private sector medical coverage and payment. Medicare payment issues span the full range of healthcare, including biotechnology and pharmaceutical products, medical devices, hospital and physician procedures. Obtaining coverage and payment in the Medicare system is crucial to patient access to new services. However, health care providers must navigate a myriad of complex and shifting coverage, payment, coding and billing policies.
Our team has extensive experience working with clients to obtain appropriate coverage and payment for a wide range of health care products and services. Foley Hoag's attorneys and specialists have worked at the Centers for Medicare & Medicaid Services (CMS) and for local Medicare contractors. Our attorneys regularly represent clients before CMS and have helped shape the outcomes of administrative processes for federal policies and programs.
Foley Hoag has developed deep expertise in working with public and private payers on new innovative products and therapies. Our strategy involves both convincing legal arguments and a rich understanding of the clinical evidence key to the product's successful adoption and utilization. Our coverage and payment team have:
- Helped CMS design and create one of the first data registries in its Coverage with Evidence Development program, by advising a coalition of leading academic medical centers and medical device manufacturers
- Worked successfully with CMS to reverse a non-coverage decision to provide beneficiary access to an important new treatment for treatment of age-related macular degeneration
- Advised numerous molecular diagnostic companies on the current Medicare coverage, payment, and billing challenges
- Represented a leading cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for an anti-cancer therapy for renal cell carcinoma and melanoma
- Developed novel legal arguments and assembled compelling scientific evidence that secured a critical policy decision affecting the coding and payment for biotechnology products
Legislative Representation
Our Government Strategies Group has a substantial legislative experience with the United States Congress. Many attorneys in this group have worked in Congress and as congressional staff members and have drafted important pieces of health legislation over the past decade, including:
- 1997 Food and Drug Administration reform law
- Orphan Drug Act
- Health Insurance Portability and Accountability Act of 1996
- Other comprehensive health care reform legislation
- Legislation involving specific changes to Medicare and Medicaid law
We use this in-depth experience to provide knowledgeable legal and legislative counsel to our individual and corporate clients regarding a wide range of legislative matters. For our clients, we have prepared draft legislation and analyzed legislative proposals, interacted with congressional members and staff, prepared congressional testimony and advised our clients in connection with committee and subcommittee hearings.
Foley Hoag has worked over the past several years on numerous pieces of major legislation affecting the pharmaceutical, medical device and biotechnology industries. As part of our approach to solving client problems, Foley Hoag’s lawyers assist clients in presenting their concerns to members of Congress. Some of the specific legislation in which we have been involved includes:
- In connection with the reauthorization of the Prescription Drug User Fee Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act, Foley Hoag represented several leading pharmaceutical and biotechnology companies and industry trade associations.
- We represented clients under the Orphan Drug Act, which is credited with giving rise to the biotechnology industry, through its provision of seven years of marketing exclusivity to companies that develop drugs or biologics for patients with rare diseases.
- Foley Hoag is presently representing leading pharmaceutical and biotechnology companies in connection with legislative efforts to provide a prescription drug benefit for Medicare beneficiaries.
- We are involved in issues related to "Hatch-Waxman" patent-term issues.
- Foley Hoag has represented our clients on issues related to drug pricing and reform of the Average Wholesale Price (AWP) for drugs.
Representative experiences
- Represented a collection of leading academic medical centers and manufacturers of medical devices in their efforts to obtain coverage and reimbursement for new diagnostic imaging technology.
- Provided counsel to a leading biotechnology company and cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for therapy for renal cell carcinoma and melanoma.
- Represented a leading biotechnology company in increasing hospital outpatient reimbursement for supportive anti-cancer therapy.
- Expanded coverage of leading therapy for the treatment of age-related macular degeneration, which had been previously non-covered.
- Represented a leading pharmaceutical manufacturer in achieving unprecedented coverage of an oral drug under Medicare Part B.
