U.S. Federal Topics

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.

340B Drug Pricing Program

• PPTA Letter re: Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program [RIN 0906-AA94] (July 19, 2011)
• PPTA Letter to the Health Resources and Services Administration, U.S. Department of Health and Human Services re: Civil Monetary Penalties (November 2010)
• PPTA Letter to the Health Resources and Services Administration, U.S. Department of Health and Human Services re: Administrative Dispute Resolution Process (November 2010)
• 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)
• PPTA Letter to Senate HELP Committee re: Sections 611 and 612 of the Affordable Health Choices Act (June 30, 2009)

Annual Pharmaceutical Fee

• PPTA Letter of Support to House Committee on Ways and Means regarding the "Preserving Access to Orphan Drugs Act of 2011" (HR 2672) (Sept. 23, 2011)
• PPTA Letter of Support to House Committee on Energy and Commerce, regarding the "Preserving Access to Orphan Drugs Act of 2011" (HR 2672) (Sept. 23, 2011)
• PPTA Letter of Support regarding the "Preserving Access to Orphan Drugs Act of 2011" (HR 2672) (August 24, 2011)
• PPTA Letter of Support regarding the "Preserving Access to Orphan Drugs Act of 2011" (S 1423) (August 24, 2011)
• PPTA Comments to IRS regarding Guidance Implementing the Annual Pharmaceutical Fee on Branded Prescription Drug Sales (June 15, 2011)

Comparative Effectiveness Research

• PPTA Letter to Gene Dodaro, Acting Comptroller General, Attn: Board of Governors of the Patient-Centered Outcomes Research Institute (June 30, 2010)
• PPTA Letter to Senators Baucus and Conrad regarding Support for the Patient-Centered Outcomes Research Act of 2009 (S 1213) (July 10, 2009)
• PPTA Letter to Senators Baucus and Conrad regarding Comparative Clinical Effectiveness Research - Comments on S. 3408 from the 110th Congress (March 2, 2009)

Deficit Reduction

• PPTA Letter to the Joint Select Committee on Deficit Reduction (September 16, 2011)

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 the Pathway for Biosimilars Act (HR 1548) (May 12, 2009)
   

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Healthcare Reform

• PPTA Letter to the Health and Human Services (HHS) regarding  pre-regulatory guidance on Essential Health Benefits Bulletin (January 31, 2012)
• PPTA Statement on Health Reform Law (March 30, 2010)
• PPTA Letter to the Senate Finance Committee regarding Financing Comprehensive Health Care Reform: Proposed Health System Savings and Policy Options (May 26, 2009)
• PPTA Health Care Reform Principles(May 2009)

Medicare Coverage of Plasma Protein Therapies  (Administrative Initiatives)

• PPTA Letter to CMS Re: Hospital Outpatient Prospective Payment System Calendar Year 2012 Proposed Rule (CMS-1525-P) (August 30, 2011)
• PPTA Letter to FDA and CMS Re: Parallel Review of Medical Products (Docket No. FDA-2010-N-0308) (December 2010)
• PPTA Letter to CMS Re: CMS-1504-P - Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates (August 2010)

         <--->  See Previous Letters

 

Medicare Coverage of Plasma Protein Therapies  (continued)

• PPTA and Stakeholder Joint Letter regarding Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010 (CMS-1413-P) (August 2009)
• PPTA and Stakeholder Joint Letter regarding 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 CMS -1414-P) (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 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 Follow-On Biologics (H.R 1956), the Patient Protection and Innovative Biologic Medicines Act of 2007 (HR 1956) (June 2007)

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