With drug pricing in the crosshairs of executive and legislative action at both the federal and state levels, the stakes for pharmaceutical and biologics companies have never been higher. Drawing on deep knowledge of all areas of drug pricing regulation, Ropes & Gray’s cross-practice drug pricing team provides life sciences enterprises with strategic business and legal advice on existing and proposed government approaches to prescription drug pricing and price reporting. Our team provides informed counsel on, among other pricing-related matters, on the Medicaid Drug Rebate Statute, Section 340B of the Public Health Service Act, Medicare Average Sales Price reporting and the ever-growing spectrum of state drug pricing initiatives. We advise on commercial market strategy to promote robust access to and appropriate reimbursement of drugs, including value-based contracts.
Our team counsels on proposed reforms to Medicare Parts B, C and D, and Medicaid managed care reimbursement and delivery models, on reforms that would more strictly regulate entities within the pharmaceutical supply chain, such as PBMs, and on reforms related to the offering of discounts or rebates on drugs. Additionally, we advise clients on initiatives to increase FDA and FTC activity to address alleged “gaming” of generic drug approvals, the increasingly noisy conversation encouraging the Federal government to use “march-in” rights or its eminent domain powers to license competitive drugs or work around intellectual property rights. In addition to this counseling and transactional work, we have a deep bench of litigators who represent manufacturer clients in enforcement proceedings and civil litigation around price reporting. Among other achievements, our litigators have successfully blocked public disclosure of our clients’ drug pricing and other proprietary information submitted to government agencies, including in cases when media outlets or competitors sought to obtain such information under public record laws.
As legislators, regulators, and enforcement agencies continue to focus on prescription drug pricing, pharmaceutical companies must navigate evolving legal and business questions. Ropes & Gray’s cross-practice drug pricing team provides life sciences enterprises with strategic business and legal advice on existing and proposed government approaches to prescription drug pricing and price reporting. Our team provides informed counsel on, among other pricing-related matters, reporting and other obligations under the Medicaid Drug Rebate Statute, Section 340B of the Public Health Service Act, the Medicare Statute, and the growing number of state drug price transparency, supply chain (e.g. PBM) and other regulations and statutes. We actively monitor federal and state proposed reforms that would change the coverage, reimbursement, and/or delivery landscape for drugs or generally alter business relationships within the pharmaceutical supply chain (e.g., by reforming rebate safe harbors). We also advise clients on initiatives to increase FDA and FTC activity to address alleged “gaming” of generic drug approvals. When drug pricing or price reporting issues need to be litigated, we draw on our deep bench of civil and criminal litigators. We have successfully defended clients in enforcement proceedings and civil litigation involving alleged deficiencies in price reporting, and blocked disclosure of pricing and other proprietary information in litigation under state public disclosure laws.
- The firm has a cross-practice Drug Pricing Working Group that is a well-recognized thought leader, contributing on a regular basis to trade press concerning U.S. federal and state regulatory and legislative initiatives addressing prescription drug pricing and price reporting.
- Our lawyers routinely advise pharmaceutical manufacturers on compliance with federal drug price reporting requirements under the Medicaid Drug Rebate Statute, Section 340B of the Public Health Service Act, and the Medicare Statute. We assist manufacturers in interpreting applicable law, drafting reasonable assumptions to support their price reporting submissions, and preparing affirmative disclosures to the government and responses to government inquiries. We also provide strategic advice on manufacturer rights and legal obligations under the Medicaid Drug Rebate Statute, Section 340B of the Public Health Service Act, and the Medicare Statute, and advocate for clients in connection with U.S. federal government proposed legal reforms.*
- In connection with strategic investments and acquisitions by pharmaceutical manufacturers, as well as private equity and public company financing, we regularly advise on the compliance profile of a target company under current U.S. pricing and price reporting requirements, such as the Medicaid Drug Rebate Program, Section 340B of the Public Health Service Act, and Medicare average sale price. Our lawyers also advise on the value of the projected market, based on a therapy’s overall coverage, reimbursement, and pricing profile.
- We routinely advise pharmaceutical and medical device manufacturers on compliance with federal and state marketing and disclosure laws, including the so-called federal sunshine or open payments law.
- We are advising several of the world’s largest manufacturers on the growing number of state laws that impose, and state legislative efforts to impose, drug price reporting transparency and other requirements on prescription drug manufacturers, distributors, and pharmacy benefit managers. We routinely advises on reporting obligations under those statutes (including as they relate to drug launches and company pricing decisions) and affirmative steps to protect proprietary, confidential and trade secret information. Our lawyers also have successfully challenged, through the administrative process, multiple sizeable penalties that state agencies have imposed on manufacturers under drug price transparency statutes. *
- For a major Chinese prescription drug maker, we have advised on the implications of pending U.S. drug pricing and price reporting reform proposals on a potential licensing arrangement with a U.S.-based manufacturer.
- We are advising multiple pharmaceutical and medical device manufacturers on structuring patient support programs (reimbursement support hotlines/guides, copay assistance programs, long and short term free drug programs) to address patient access challenges, including coverage and reimbursement challenges. Our advice has included review of policies, procedures and practices as well as proposed initiatives. Our advice also takes into account drug pricing reform and industry trends (e.g., health plan treatment of manufacturer copay assistance).
- We have assisted various pharmaceutical manufacturers with the development of fair market value rate schedules for health care consultants and other healthcare service providers, including specialty pharmacies.
*Includes experience prior to joining Ropes & Gray