Access to Care | U.S. Federal

Capitol

PPTA prepares policy documents (such as issue briefs, statements, backgrounds, and white papers) on a variety of policy topics that are relevant to protecting patient access and are important to the association and its members. In addition, the Association provides comment letters to federal agencies such as the Centers for Medicare and Medicaid Services (CMS) and other government-related entities that engage in rulemaking or soliciting stakeholder feedback. PPTA also writes letters to Members of Congress, Congressional Committees, and federal agencies in support of policy proposals that help ensure access to plasma protein therapies.

The federal advocacy priorities are: access to therapies, Medicare coverage, health care reform, orphan drugs and therapies, and comparative effectiveness research. Association policy documents are provided for each.

Access to Therapies

The majority of plasma protein therapies are used by patients with rare, chronic and life-threatening diseases and conditions. Plasma protein therapies represent a unique class of human- and cell-derived branded biologicals. From the source material originating from donated plasma, through purification, fractionation and final distribution, the production of these lifesaving therapies is distinct from the larger biopharmaceutical industry, and similarly produces distinct, non-interchangeable treatments. PPTA is committed to preserving timely and appropriate access to all brands of life-saving plasma protein therapies in all sites of care. PPTA meets frequently with Members of Congress and the Administration to ensure that policies impacting the plasma protein community reflect the distinct position of the plasma protein industry, as well as the unique nature of the rare disease patient who rely on these therapies for their lifesaving treatment.

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Medicare Coverage

Plasma protein therapies used by Medicare beneficiaries predominately are reimbursed through Medicare Part B, which covers physician-administered therapies. It is essential that reimbursement for plasma protein therapies is sufficient to maintain access. PPTA regularly meets with staff on the relevant Congressional Committees handling Medicare policy to discuss the unique needs of the industry and patients and the importance of considering rare disease patients and treatments in health policies.

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Health Care Reform

The Affordable Care Act (ACA) contained many important provisions for people with chronic and rare diseases. However, as the ACA is implemented, it is vital to ensure that patients do not encounter access issues. PPTA is monitoring implementation of ACA to make sure it does not adversely affect patients who rely on life-saving plasma protein therapies.

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Orphan Drugs and Therapies

The Orphan Drug Act, enacted 30 years ago, continues to stimulate a healthy environment for the development of rare disease therapies. Given that the majority of plasma protein therapies are used by patients with extremely rare diseases and conditions, PPTA continually monitors and promotes policies that support the investment in innovation and marketing of these therapies.

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Comparative Effectiveness Research

PPTA recognizes the importance of advancing informed healthcare decisions through independent comparative research and studies. The intended use of comparative research results is to assist patients, clinicians, purchasers and policy-makers in making informed health decisions on how to effectively and appropriately prevent, diagnose, treat, monitor and manage diseases. It is essential to consider the effect of such research on rare disease patient populations and the ability to access the plasma protein therapy that will promote the best health outcome for the patient.

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340B Discount Drug Pricing Program

All PPTA members participate in the 340B program which provides steep discounts on drugs and therapies to safety-net hospitals and other statutorily covered entities. PPTA closely monitors policy developments related to oversight and integrity of the 340B program covered entities in order to protect access to life-saving plasma protein therapies.

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