OUR EXPERIENCE

The specialty pharmacy industry continues to experience explosive growth and transformation, with specialty pharmaceuticals now representing approximately 55% of the U.S. drug market and dispensing revenues reaching an estimated $265 billion in 2024. These high-cost medications help treat patients with complex conditions such as multiple sclerosis, rheumatoid arthritis, cancer, and hemophilia. Whether taken orally, infused or injected, they typically require special handling, monitoring and specialty expertise that only a limited number of pharmacies are equipped to provide. The industry faces unprecedented challenges from vertically integrated PBM-insurer-pharmacy chains, increasingly aggressive audit practices, and evolving regulatory requirements—all of which carry significant legal ramifications. Many specialty pharmacies have discovered that expert advice by an experienced law firm, such as MDRXLaw, can add great value to their businesses and help them navigate this complex landscape.

In addition to being a recognized industry leader in the area of pharmacy law and practice, over the years, MDRXLaw has developed an expertise in the area of specialty pharmacy representation. We understand the unique challenges facing specialty pharmacies and other key players in the industry and have the knowledge, experience, and resources to efficiently deliver outstanding results.

We have experience dealing with the wide range of issues facing specialty pharmacy providers, such as:

• PBM Contracting. We assist our clients with issues involving access to preferred networks, leveraging many tools including federal and state any willing provider laws.

• Accreditation by URAC and ACHC. We have a wealth of experience in accreditation of specialty pharmacies by URAC and ACHC. Our professionals include certified ACHC consultants. Our track record ensures that your accreditation process proceeds smoothly and expeditiously.

• PBM Audits and Contract Terminations. We aggressively defend specialty pharmacy providers in connection with audits and investigations by PBMs and governmental payors and fight on behalf of providers in the event of unfair and frequently unlawful attempts by PBMs to terminate our clients’ contracts.

• Access to Limited Distribution Drugs. We help pharmacy providers with the legal aspects of gaining access to limited distribution drugs in situations when the manufacturer’s position is legally unsupportable and practically untenable.

• Mergers & Acquisitions. Over the years, we have served as lead counsel in connection with major and notable sales, mergers, and acquisitions in the specialty pharmacy industry. We understand the special challenges and the full range of issues presented in connection with transactions involving specialty pharmacies. We work closely with accounting firms, banks, M&A advisors, private equity companies, consultants, and others to achieve the most desirable financial and business outcomes for our clients.

• DIR Fees. We understand the challenges presented, and the issues raised, by DIR fees imposed by major PBMs. We are at the forefront of the most recent developments involving this controversial issue, and aggressively advocate on behalf of our clients faced with this extraordinary challenge.

• Proper Structure of Specialty Pharmacy Businesses. Our understanding and experience in corporate and business matters, in conjunction with our solid regulatory background and knowledge of business realities, allow us to effectively counsel clients on the choice and structure of their business entities to permit smooth and efficient operation.

• Labor and Employment Issues. We have extensive experience counseling clients on proper ways to manage and operate their sales force and other employees in the face of intense regulatory scrutiny and complex business and legal environments in the constantly evolving field of labor relationships.