Policy Issues in the Development of Personalized Medicine in Oncology Workshop Summary (2010) / Chapter Skim
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Reimbursement
Reimbursement
Pages 49-62
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From page 49... ...
MEDICARE COvERAGE OF PREDICTIvE TESTS Dr. Roche explained that the Social Security Act of 1965 established Medicare, a health insurance program run by the U.S.
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From page 50... ...
For example, some local contractors cover gene marker tests for hereditary cancer syndromes, including ovarian cancer and colorectal cancer, assuming certain conditions are met (i.e., the individual is clinically affected by the disorder and is willing to undergo pretest genetic counseling)
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Dr. Roche acknowledged the inconsistency in policy, but pointed out that "when you lose local coverage discretion, you're also losing the ability of a local coverage organization to respond to the needs that are being expressed in that region of the country." Dr.
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(The CPT code categorizes the diagnostic and ultimately determines its fee rate.) To determine the CPT code for new tests, the code can be crosswalked to an existing test, pricing the new test at the same rate as a similar test that already has a CPT code, or "gap filled." Gap filling requires Medicare contractors to collect data specific to their geographic area and to set a new price that reflects those data.
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Laboratories that choose to do the better PCR-based methylation test are paid less than those that TAbLE 2 Current System of CPT Codes Pays for Activity, Not Value CPT Code Process Units Rates Southern methylation analysis 1 Extraction 1 $26.00 2 Digestion 1 $51.00 3 Separation 1 $26.00 4 Nucleic acid probe 1 $26.00 5 Southern blot 1 $52.00 6 Interpretation/report 1 $26.00 Total = $207.00 PCR methylation analysis 1 Extraction 1 $26.00 2 Digestion 1 $51.00 3 Separation 1 $26.00 4 Interpretation/report 1 $26.00 Total = $129.00 NOTE: CPT = Current Procedural Terminology, PCR = polymerase chain reaction.
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From page 54... ...
Bassano stated that Medicare prefers to have one payment for all the services provided to a patient during a hospital stay. This often means that the reimbursement for a test done on a specimen collected during a hospital stay is bundled with a reimbursement payment for other hospital services.
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She said industry claims the inpatient bundling of payments was not intended to cover the costs of expensive, complex tests, and that such bundling inhibits the development of tests performed in a single location. Laboratories do not want to negotiate the reimbursement rates for their tests with hospitals located throughout the country, and would rather negotiate directly with local Medicare contractors, Dr.
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Hayes stressed. Over the past 14 years, the ASCO Tumor Marker Guidelines Panel has only recommended the use of four tumor markers, despite publications on hundreds of such putative markers.
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Unfortunately, doing large, controlled, prospective clinical trials of tumor markers would be much more costly, and untenable given the current reimbursement rates for predictive tests, Dr. Hayes said.
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Previously, grants for clinical research on tumor markers were inappropriately reviewed by the pathology or therapeutic study sections. Another positive step is the fact that criteria for reporting tumor marker studies have been recently developed and adopted by scientific journals (Bossuyt et al., 2004; McShane et al., 2005)
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In addition, Dr. Hayes suggested changing the method of caregiver reimbursement so that doctors can spend more time with their patients explaining predictive tests, and not be financially penalized for not recommending chemotherapy because the test indicates it will not be effective.
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Dr. Herbst also urged early reimbursement in clinical trials of tests that assess multiple tumor markers "so you can [assess]
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We say ‘you need more evidence,' but against what standard? There's absolutely none." He stressed that predictive tests are conceptually quite different from therapeutics, and should be evaluated differently.
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