Plasma-Derived and Recombinant Therapies

• CMS Releases Third Quarter Payment Rates for Drugs and Biologicals
• HOPPS Payment Rate Change
• Competitive Acquisition Program (CAP) Interim Final Rule Released under The Centers for Medicare and Medicaid Services
• Plasma-Derived and Recombinant Therapies

As a result of strong lobbying efforts to exclude blood clotting and Alpha1 therapies, CMS has determined in their interim final rule to not include such therapies within the CAP. CMS stated that blood-clotting factors will be treated similar to IVIG therapies, and will not included in the program. CMS also decided to exclude single-indication orphan drugs, as defined by CMS under the Outpatient Prospective Payment System (OPPS) from the CAP. Orphan drug status is defined under OPPS as:

• The drug is designated as an orphan drug by the FDA and approved by the FDA only for the treatment of only one or more orphan conditions (s); and
• The current United States Pharmacopoeia Drug Information (USPDI) shows that the drug has neither an approved nor off-label use for other than the orphan condition (s).

CMS stated within the interim final rule that they did not necessarily agree with comments to the proposed rule regarding the exclusion of IVIG from CAP. This is despite what seems to be clear statutory language, specifically section 303(b)(1)(E)(ii) of the MMA. Nevertheless, CMS did state that neither IVIG nor blood clotting factors will be included within the CAP and should the agency have a change in policy at a later date regarding these therapies, they will issue a proposed rule and solicit comment prior to inclusion within the CAP. Regarding the single-indication orphan therapies such as Alpha1 - proteinase inhibitor, CMS did raise concerns about access issue if these therapies were to be included within the CAP. While reserving the right to incorporate within the CAP at a later date, it does not seem likely that CMS would include the single-indication orphan therapies. The interim final rule also excluded other immune globulins from CAP but did reserve the right to incorporate within the CAP at a later date.

ZLB Behring will continue to closely monitor all CMS activities as they relate to plasma-derived and recombinant therapies in order to ensure providers and patient’s have unimpeded choice of therapies and continued proper access to care. For more information regarding our Reimbursement Alert publication, interested parties may contact us via the Toll-Free Reimbursement Answerline at 1-800-676-4266.

REFERENCES:

Department of Health and Human Services, Centers for Medicare and Medicaid Services: 42 CFR Part 414, (CMS-1325-IFC), RIN 0938-AN58. Medicare Program, Competitive Acquisition of Outpatient Drugs and Biologicals under Part B.

ZLB Behring assumes no responsibility for the individual interpretation of any material, facts, or references provided within the context of its publication of Reimbursement alert.

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Reimbursement Alert June / July 2005

Previous: Competitive Acquisition Program (CAP) Interim Final Rule Released under The Centers for Medicare and Medicaid Services

ZLB Behring assumes no responsibility for the individual interpretation of any material, facts, or references provided within the context of its publication of Reimbursement alert.