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Plasma Protein Therapeutics Association Urges CMS For Appropriate Hospital Outpatient Drug Reimbursement

ANNAPOLIS, Md., Aug. 11 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) supports the favorable recommendation of average sales price (ASP) + 6 percent for reimbursement of separately paid drugs and biologics in the hospital outpatient setting made by the Centers for Medicare and Medicaid Services' (CMS) Advisory Panel on Ambulatory Payment Classification (APC) at its August 5-7 meeting, although third party data maintains that ASP +12 percent is the appropriate reimbursement level.

PPTA presented the APC Panel with compelling evidence demonstrating that setting the current ASP + 4 percent payment rate was based to some extent on flawed hospital claims data and is insufficient to assure patient access to lifesaving plasma protein therapies.

PPTA's comments as part of the stakeholder panel focused largely on evidence that sales into the 340B Drug Discount Pricing Program are skewing CMS's rate setting calculation in the Outpatient Prospective Payment System (OPPS). Further, health care reform legislation if enacted will exacerbate the disparity, given that proposals to expand 340B and to increase the Medicaid outpatient drug rebate percentage will result in a larger volume of products being sold at significantly deeper discounts to 340B hospitals.

In its testimony, PPTA referenced data compiled by The Moran Company, a Washington, D.C.-based health care research and consulting firm, which revealed that removing 340B sales from the rate setting and reallocating the $150 million CMS has proposed to move from packaged drugs to separately payable drugs to cover pharmacy overhead costs results in the more appropriate ASP +12 percent reimbursement level.

The 340B program limits the cost of covered outpatient drugs to certain federal grantees, federally-qualified health centers, qualified disproportionate share hospitals and hemophilia treatment centers. The program currently provides access to 340B sub-ceiling prices for more than 2,800 drug products including biologics.

Maintaining an appropriate reimbursement level is an important step in assuring access to plasma protein therapies, which are highly complex biologics, for Medicare beneficiaries suffering from rare, chronic and genetic diseases and disorders including primary immunodeficiency diseases, hemophilia and other bleeding disorders and alpha-1 antitrypsin deficiency, a genetic lung disease. Plasma protein therapies refer to plasma-derived and recombinant blood clotting factors, as well as alpha-1 proteinase inhibitor and immune globulins.

Additionally, the CMS' proposal to continue to insufficiently reimburse plasma protein therapies could make innovative advances, such as a recently approved biologics license application for a coagulation therapy used to treat a disorder afflicting only 300 people in the United States, cost prohibitive in the future.

The APC Panel's recommendation is an important step on the way to preserving patient access to lifesaving therapies, and PPTA urges CMS in 2010 to at a minimum restore the payment level to ASP +6 percent, which is consistent with reimbursement of these drugs in the physician office setting.

Go online for a copy of PPTA's written testimony, or contact Kym Kilbourne at 443-995-2102 or email her at More information about the Plasma Protein Therapeutics Association (PPTA) can be found at

The Plasma Protein Therapeutics Association (PPTA) is the trade association and standard setting organization for the world's major producers of plasmaderived and recombinant analog therapies (collectively, "plasma protein therapies"). These therapies are used by more than 1 million worldwide each year to treat a variety of diseases and serious medical conditions. PPTA members produce over 80 percent of the plasma therapies for the United States market and more than 60 percent worldwide. Some of the critical therapies produced by PPTA members include: blood clotting factors for people with hemophilia, immune globulins used to prevent infections in people with immune deficiencies and other serious conditions, and alpha1 proteinase inhibitor used to treat people with alpha1antitrypsin deficiency, also known as genetic emphysema.

SOURCE Plasma Protein Therapeutics Association
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