U.S. Federal Issues

Access to Therapies

PPTA works with Congress and various agencies within the United States Department of Health and Human Services in communicating the importance of unfettered consumer access to all plasma-derived and recombinant analog therapies (collectively "plasma protein therapies") while at the same time educating policymakers on the unique, niche biologics industry that produces these life-saving medicines.

In 2009 PPTA produced a new advocacy advertising series for a Capitol Hill newspaper that builds off of the messages delivered in the April 28, 2009 advertorial in Politico. Visit Advocacy Advertisements to see or download a PDF of the advertisments.

Visit the White House website to view a video about Denver, Colorado resident Nathan Wilkes, his wife Sonji and their young son Thomas who has severe hemophilia talk about the emotional and financial impact that treating a rare, chronic disease can have on a family. Hemophilia is treated with blood clotting factor, a plasma protein therapy (plasma protein therapies are plasma-derived therapies and their recombinant analogs). Nathan sat with First Lady Michelle Obama in her box during the President's September 9 speech to Congress on health care reform priorities. See the guest list.

Health Care Reform

• Letter to the Senate Finance Committee re: Financing Comprehensive Health Care Reform: Proposed Health System Savings and Policy Options (May 26, 2009)
• PPTA Health Care Reform Principles (May 2009)

Follow-on Biologics

• FDA Week article "Makers of Plasma Protein Therapies Support Eshoo's Biosimilars." (July 10, 2009)
• Side-by-side comparison of follow-on biologics bills before the Senate HELP Committee (July 9, 2009)
• White Paper: Patients Who Depend on Plasma Protein Therapies Need Legislative Protection from Unpredictable Risks to Which an Abbreviated Product Approval Pathway Could Expose Them (June 4, 2009)
• Link to Federal Trade Commission report: Emerging Health Care Issues: Follow-on Biologic Drug Competition (June 2009)
• Letter to Representatives Eshoo, Barton and Inslee regarding H.R. 1548, the Pathway for Biosimilars Act (May 12, 2009)

Comparative Effectiveness Research

• Letter to Senators Baucus and Conrad re: Support for S. 1213, the Patient-Centered Outcomes Research Act of 2009 (July 10, 2009)
• Letter to Senators Baucus and Conrad re: Comparative Clinical Effectiveness Research - Comments on S. 3408 from the 110th Congress (March 2, 2009)

340B Drug Pricing Program

• PPTA Letter to Jimmy R. Mitchell, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, U.S. Department of Health and Human Services re: The Disproportionate Share Hospital Prohibition for Purchasing from Group Purchasing Organizations (September 23, 2009)
• Letter to Senate HELP Committee re: Sections 611 and 612 of the Affordable Health Choices Act (June 30, 2009)

Medicare Coverage of Plasma Protein Therapies

Administrative Initiatives

• PPTA and Stakeholder Joint Letter: Re: CMS–1413–P (Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010) (August 2009)
• PPTA and Stakeholder Joint Letter: RE: CMS -1414 – P (Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Proposed Changes to the Ambulatory Surgical Payment System and CY 2010 Payment Rates) (August 2009)
• PPTA Statement to the Advisory Panel on Ambulatory Payment Classification Groups regarding Hospital Outpatient Prospective System Payment Rates (August 2009)
• PPTA Comment Letter to CMS on the Outpatient Prospective Payment System and CY 2009 Payment Rates; Re: CMS -1404-P Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates (September 2008)
• PPTA Comment Letter to CMS on the Physician Fee Schedule and CY 2009 Payment Rates; Re: CMS-1403-P Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and other Revisions to Part B CY 2009 (August 2008)
• Principles for the Establishment of Prescription Drug Pedigree Requirements for Plasma Protein Therapies (January 2008)
• PPTA Comment Letter to CMS on the final rule pertaining to prescription drugs under the Medicaid Program RE: CMS–2238 - FC Final Rule: Medicaid Program; Prescription Drugs (January 2008) 
• PPTA Comment Letter to CMS on the Outpatient Prospective Payment System and CY 2008 Payment Rates; RE: CMS-1392-FC Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates (January 2008)
• PPTA Comment Letter on the Discussion Draft on the Wholesale Distribution of Prescription Drugs (October 2007)  
• PPTA Comment Letter to CMS on the CY 2008 Hospital Outpatient Prospective Payment System Proposed Rule (September 2007)
• PPTA Comment Letter to CMS on its Proposal for the 2009 Healthcare Common Procedure Coding Systems Codes Application (September, 2007)
• PPTA Comment Letter to CMS on the CY 2008 Physician Fee Schedule Proposed Rule (August 2007)
• PPTA Letter of Support for H.R. 1956 Follow-On Biologics; H.R. 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007 (June 2007)