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PPTA Urges CMS for Appropriate Hospital Outpatient Reimbursement for Plasma Protein Therapies

ANNAPOLIS, Md., Aug. 18, 2011 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) recommends that the Centers for Medicare and Medicaid Services (CMS) take necessary steps to improve drug reimbursement under the Hospital Outpatient Perspective Payment System (OPPS).

At last week's Advisory Panel on Ambulatory Payment Classification (APC) Groups meeting, PPTA testified that the continued failure by CMS to remove hospitals that purchase drugs under the 340B program from its OPPS reimbursement rate-setting calculation may create difficulties for patients in their attempt to access some drugs and biologicals because including 340B sales in the calculation artificially lowers the payment level.

The agency sets the payment level for separately payable drugs and biologicals with non-pass-through status based on their ratio of cost to average sales price (ASP).  The cost totals are based on claims data from all hospitals, including 340B hospitals, but the ASP data excludes 340B sales. Setting the rate in this manner does not reflect the actual cost of acquiring and preparing drugs and biologicals for any hospitals, because 340B sales prices are well below ASP.  For those hospitals not receiving the 340B discount on drug purchases, their reimbursement level may become too low to be able to continue offering certain drugs and biologicals to their patients for administration.

Based on this calculation, CMS has proposed for calendar year 2012 to set the payment level of separately payable non-pass-through drugs and biologicals, which include most plasma protein therapies, at ASP plus 4 percent. The current payment level is ASP plus 5 percent.  PPTA believes, however, that this payment rate should be no less than ASP plus 6 percent to help ensure that hospital outpatient departments remain a viable option for beneficiaries to receive therapies such as alpha-1 proteinase inhibitor, blood clotting factors and intravenous immune globulin (IVIG). "PPTA has long advocated for parity between the statutory physician office rate of ASP plus 6 and the OPPS rate," said Julie Birkofer, senior vice president, North America, PPTA. "This inequality between sites of service has been problematic in the past for patient access to plasma protein therapies."

PPTA testimony also underscored the staggering growth of 340B hospital sites in recent years.  The number of 340B hospital sites has more than doubled in three years – from 2,213 enrolled in the fourth quarter of 2008 to 4,427 enrolled today.  This growth of the 340B program will exacerbate the flawed nature of the agency's rate setting calculation, according to PPTA.  

Although PPTA advocates for removing 340B sales from the CMS rate setting calculation, it cautioned against establishing two payment rates – one for 340B hospitals and one for non-340B hospitals.  "Reducing Medicare payments to 340B hospitals [through a separate payment rate] for separately paid drugs would undermine the purpose of the 340B program to reach more eligible patients and provide more comprehensive services," said Birkofer.

Maintaining an appropriate reimbursement level is an important step in ensuring 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.

PPTA testified as part of a panel of stakeholders advocating to improve drug reimbursement under OPPS and providing input on the 2012 OPPS Proposed Rule. The group comprised representatives from the Association of Community Cancer Centers, Biotechnology Industry Association (BIO), and the Alliance of Dedicated Cancer Centers.  The stakeholders also urged the APC Advisory Panel to recommend that CMS reallocate more money than the proposed $215 million in pharmacy overhead costs from packaged drugs to separately payable drugs by redistributing the same percentage of costs from the coded and uncoded packaged drug pools.  PPTA was deeply disappointed that the Panel failed to make of the stakeholders' proposed recommendations to the agency at the conclusion of the meeting.

PPTA appreciates the opportunity to testify with stakeholders at the APC Advisory Panel meeting and make recommendations to CMS that will help ensure access to plasma protein therapies for rare disease patients.

For more information about PPTA, please visit or contact Kym Kilbourne at 443-458-4682 or 443-995-2101.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.

Contact:Kym H. Kilbourne





SOURCE Plasma Protein Therapeutics Association (PPTA)
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