Kristina Giyaur, Esq.

Representing Specialty Pharmacies

The specialty pharmacy industry is undergoing rapid growth and profound transformation.  By 2018–2020, 50% of all drugs sold in the United States are expected to be specialty pharmaceuticals, compared with 30% today. 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.  Yet, the industry is constantly evolving and undergoing profound changes, many of which have 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. 

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.

  • Assisting specialty pharmacies with all legal and regulatory challenges, including establishment and mergers and acquisitions
  • Expert advice and counseling on acreditation, PBM contracting, and limited distribution agreements
  • Deep understanding of issues surrounding operations of specialty pharmacies to ensure relevant and cost-efficient advice