September 07, 2010
ANNAPOLIS, MD (September 7, 2010)—The Plasma Protein Therapeutics Association (PPTA) recommends that the Centers for Medicare and Medicaid Services (CMS) finalize its Proposed Rule regarding reimbursement to better ensure patient access to vital medicines in the hospital outpatient setting.
Specifically, for CY 2011, CMS proposes to set the payment level of separately payable non-pass-through drugs and biologicals, which include most plasma protein therapies, at average sales price (ASP) plus 6 percent. PPTA supports this proposal, believing that by setting payment rates at no less than ASP plus 6 percent, CMS will help ensure at this time 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).
Furthermore, the proposed payment rate for hospital outpatient departments would put such products on par with the rates paid for pass-through drugs and biologicals in the physician office setting, thus, better assuring Medicare patients that they will have access to their necessary medications in either site of service.
“By matching payment levels in both the hospital outpatient department and the physician office, the choice of setting would be driven by clinical, not financial considerations, as it should be,” said Julie Birkofer, Senior Vice President, PPTA North America.
Additionally, PPTA praised the agency’s proposal to continue reimbursing hospitals for the “furnishing fee” for blood clotting factors, recommending that the proposal be made final.
While CMS’ proposal makes strides with ensuring patient access to plasma protein therapies for small patient populations, PPTA continues to have concerns with the agency’s flawed policy of using hospital claims data that includes drugs and biologicals sold as part of the heavily discounted 340B Drug Pricing Program when setting Outpatient Prospective Payment System (OPPS) payment rates. The 340B program limits the cost of covered outpatient drugs to certain federal grantees, federally-qualified health centers and qualified disproportionate share hospital.
In recent years, analysis of hospital claims data by multiple experts reveal that the inclusion of 340B hospitals when establishing rates artificially lowers the payment level that CMS generates, concluding that if CMS were to exclude 340B hospitals from its claims data analysis, the rate would more appropriately be as high as ASP plus 12 percent. This payment rate would be consistent with the calculation of other payment methodologies, including the ASP, the average manufacturer’s price, and the best price. The Association continues to recommend that these data be removed from rate setting calculations.
PPTA appreciates the opportunity to comment on the Proposed Rule. The Association especially supports CMS’ decision to continue the blood clotting factor furnishing fee in the OPPS for CY 2011 and urges the agency to finalize it with the pertinent update.