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DrugDex Compendium/ Off-Label Coverage under Medicare Part B

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http://www.oncologystat.com/home/news/D ... erage.html


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CMS now recognizes Thomson Micromedex's DrugDex compendium as an authoritative reference for determining off-label coverage of cancer drugs under Medicare Part B, the agency announced June 10.

DrugDex has been added to the list of compendia that may be used by Medicare carriers in making reimbursement decisions.

The decision is part of the agency's efforts to update its list of authoritative compendia for Part B off-label chemotherapy coverage ("The Pink Sheet," April 14, 2008, p. 15).

DrugDex provides listings of more than 2,300 drugs and biologics, including prescription, nonprescription and investigational products. Indications that DrugDex lists as class I, class II or class IIb will be considered medically accepted indications for determining coverage policy, CMS says.

During review of DrugDex, CMS received comments from the American Society of Health-System Pharmacists opposing endorsement of the compendia. The group suggested the reference guide was unduly influenced by pharmaceutical industry interests.

However, CMS concluded the "currently available body of evidence does not support" ASHP's contention, though "we would in the future consider additional evidence if provided, as well as a request to remove DrugDex from the list" of recognized compendia.

DrugDex is already used as a reference for off-label coverage in the Medicaid program, CMS noted. The agency is interested in updating the compendia used for determining drug coverage under Medicare Part D and Medicaid and is "exploring options to do so."

The idea of reconciling the compendia used by Medicare B and D and Medicaid has gained traction in Congress. CMS was directed to do so in Medicare legislation that Sen. Max Baucus, D-Mont., attempted unsuccessfully to bring up before the Senate June 12.

In light of its endorsement for DrugDex, CMS decided against recognizing a related compendium published by Thomson called DrugPoints.

DrugPoints is a summary of DrugDex. However, unlike DrugDex, the reference does not explicitly note when use of a therapy is not recommended or when evidence is determined to be equivocal. As a result, CMS felt it falls short of the relevant criteria for recognition.

The news on DrugDex follows a similar CMS announcement designating the National Comprehensive Cancer Network Drugs & Biologics Compendium as a Medicare reference ("The Pink Sheet," June 9, 2008, In Brief). A decision on one other compendium - Gold Standard's Clinical Pharmacology - is due July 2.

The NCCN guide includes 196 drugs and biologics that cover all major cancer types. It addresses all anticancer drugs recommended in the NCCN Clinical Practice Guidelines in Oncology, which are estimated to cover 97 percent of patients with cancer.

The agency notes that the indications the NCCN compendium lists as "recommended" will be considered medically accepted indications for determining coverage policy.

NCCN Category Confusion?

However, the guide has multiple ways of making recommendations and stakeholders are interested in further guidance from CMS on whether it will distinguish among the different types of endorsements.

For example, a category 1 endorsement reflects uniform consensus among NCCN panel members that the use is based on high-level evidence.

A category 2 recommendation is based on lower level evidence such as Phase II studies and clinical experience. A category 2b designation indicates there is inconclusive evidence and non-uniform consensus among NCCN panelists that an endorsement should be made.

UnitedHealth Group recently decided to use the NCCN compendium as its official reference for setting payments for off-label cancer therapy ("The Pink Sheet," Jan. 28, 2008, p. 25). The insurer covers drugs that carry category 1, 2 or 2b recommendations.

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(OncologyStat.com, The Pink Sheet Daily, By C. Kelly, June 16, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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