We have extensive experience working with pharmaceutical, biologic, and medical device manufacturers in these areas and are well-equipped to support you in refining and implementing your strategies in this increasingly volatile environment.
Contracting and counseling on U.S. government drug pricing programs and reporting obligations, pricing strategies, and risk management
For more than three decades, we have advised pharmaceutical manufacturers on matters arising under the Medicaid rebate statute (including Average Manufacturer Price and Best Price reporting), the U.S. Public Health Service Act 340B drug discount program, the Veterans Health Care Act, Medicare Part B reporting, and Part D coverage gap rebates. We have extensively represented manufacturers in negotiating commercial and Medicare Part D rebate agreements, including provisions relating to price reporting and safe harbor implications of fees.
More recently, we have advised manufacturers with respect to 340B contract pharmacy limits and rebate models, the Medicare Part B and D inflation rebate, Part D manufacturer discounts, and the Medicare price negotiation provisions under the Inflation Reduction Act. We have also represented companies with respect to state law price reporting matters (including negotiating settlements with respect to late reporting) and have advised clients on the orphan drug exception to the annual fee on branded prescription drug manufacturers and importers. Additionally, we advise clients on newer pricing and reporting issues, including the Centers for Medicare & Medicaid Services’ decision to unbundle and separately reimburse for high-cost radiopharmaceuticals.
Our work has included operational and strategic counseling, support on regulatory aspects of product acquisitions and divestitures, internal and external investigations (both as lead counsel and for regulatory subject matter advice), and assistance in developing pricing strategies and translating them into contracting approaches. Beyond providing day-to-day counseling on pricing strategies, program compliance policies and procedures, and corrections to 340B reported prices and overcharges, we have also worked with manufacturers on the settlement of government pricing liabilities in connection with false claims settlements based on Medicaid drug rebate program compliance matters.
In particular, we advise our manufacturer clients with an eye toward future risk mitigation in an increasingly volatile regulatory pricing environment.
U.S. market access contracting for drug and device manufacturers
We regularly represent manufacturers with respect to contracting with a wide variety of entities in the health care industry, ranging from advising on specific regulatory or fraud and abuse issues, to drafting template agreements and negotiating individual agreements or amendments, to supporting clients in connection with contractual disputes. These include the following:
Distribution agreements and arrangements. We represent manufacturers with respect to a wide array of agreements and arrangements relating to distribution and provision of products, including wholesaler agreements, specialty distribution agreements, limited distribution networks, provider and integrated delivery network direct sales agreements, and direct-to-consumer dispensing models, as well as related policies and terms, including product return and chargeback policies. We also provide counseling on consignment arrangements and distribution arrangements relating to various types of specialty products.
GPO agreements. We represent manufacturers in group purchasing organization (GPO) contracting for drugs (both brand and generic), medical devices, biosimilar products, and medical supplies, including traditional hospital GPOs, specialty GPOs, and wholesaler generic sourcing programs. In addition to negotiating GPO agreements in their entirety, we regularly provide fraud and abuse counseling to manufacturers on GPO discount and administrative fee terms and conditions, and assist in negotiating contract provisions that minimize risks in light of one-sided GPO templates.
Provider agreements. We assist manufacturers in contracting with a variety of providers and provider groups, including hospitals, health systems and integrated delivery networks, pharmacy chains, and physician practice management companies. In the context of specialty pharmacies, we routinely advise on both distribution pricing and enhanced service fee relationships.
Payor contracting. We have extensive experience negotiating rebate agreements with pharmacy benefit managers (PBMs), managed care organizations, and other payors (such as PBMs’ rebate-contracting affiliates), as well as their affiliates, such as specialty and mail order pharmacies. We have also assisted in negotiating supplemental Medicaid rebate agreements. We have negotiated agreements relating to formulary rebates, outcomes-based rebates (e.g., value-based rebates), price protection provisions, rebates on drugs covered under a medical benefit (including rebates on Part B drugs covered under Medicare Advantage plans), as well as various associated administrative and data fees. We have also advised on contractual provisions affecting rebate liability for drugs purchased at 340B discounted prices.
Discount pricing arrangements. We regularly advise manufacturers regarding structuring discount arrangements related to products (capital equipment and operating supplies) and services in a manner compliant with the Anti-Kickback Statute and its discount safe harbor, including bundled, volume, and outcomes-based discount arrangements.
U.S. drug and device product and patient support programs
A key part of our practice is focused on representing drug and device manufacturers and program vendors in the development and ongoing operation of patient access and product support programs, including reimbursement hotlines and training, charitable support programs, cost-sharing and other financial assistance programs, and support for adjunct services required for safe administration of products. We help our clients carefully structure their programs to navigate the regulatory minefield these programs can pose (including risks of creating health care information privacy issues, risks of running afoul of the FDA, or risks of violating the Anti-Kickback Statute, the “beneficiary inducements” civil monetary penalties law, and the False Claims Act).
For newly approved or covered products and for specialty products, product reimbursement and patient support hotlines are often a necessary element of market access. We counsel manufacturers regarding the design and administration of product and patient support programs, including product reimbursement support programs, field-based reimbursement support personnel, patient access services, “hub” arrangements, cost-sharing programs (including patient assistance, bridge programs, and coupons), and direct-to-patient sales models. We also advise clients on evolving issues such as measures to address health plan “accumulator” and “maximizer” arrangements and related regulatory developments.
Because devices are distributed through non-uniform channels (ranging from direct to consumer, to inpatient, to hospital), are sometimes diagnostic rather than therapeutic, and vary considerably in payment and cost-sharing methods (from per claim reimbursement to bundled capital and operating payment methods), creating and operating these programs is often more challenging for device manufacturers than for pharma and biologic manufacturers. We are very experienced in helping device manufacturers customize their programs, considering their unique products and needs.
For both drugs and devices, our work includes strategic design of product and patient support programs in light of health care compliance and OIG advisory opinion standards, contractual arrangements with third-party vendors implementing programs, development of policies and business rules governing operations, review of reimbursement guides, and preparation of training materials for field-based reimbursement managers.
Pricing and reimbursement capabilities in Europe
While pricing and reimbursement remain predominantly national competencies in the EU, we guide clients through the growing layer of EU level coordination, most notably the EU Health Technology Assessment framework, including joint clinical assessments and associated procedural rules. Our work also covers external reference pricing dynamics, managed entry agreements (including outcomes‑based arrangements), clawbacks and paybacks, supply and shortage obligations, indication‑based pricing, and risk‑sharing mechanisms.
