Assessing Genomic Sequencing Information for Health Care Decision Making Workshop Summary (2014) / Chapter Skim
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5 How Insurers Decide Whether to Pay for Testing
5 How Insurers Decide Whether to Pay for Testing
Pages 51-60
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From page 51... ...
and deciding to take clinical action, said Bruce Blumberg, institutional director of graduate medical education, Northern California Kaiser Permanente, Permanente Medical Group. One of the steps between actionability and action is the consideration of whether or not genomic testing costs should be reimbursed by public and private payers.
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To assess and to provide information about whether specific medical services are necessary or investigational, the Clinical Policy Unit has developed more than 700 clinical policy bulletins (CPBs) , or medical policies, including bulletins about genomic and genetic tests, which are all posted on the company website.1 CPBs describe which tests and procedures Aetna considers to be medically necessary versus those that are for cosmetic, experimental, or unproven uses.
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The Clinical Policy Unit then considers evidence-based guidelines, such as those from the American Society of Clinical Oncology and the National Comprehensive Cancer Network (NCCN) for cancer diagnostic testing.
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Upon approval of a new policy, the Clinical Policy Unit helps facilitate implementation across coding and reimbursement areas. Covered Genetic Testing Examples of genomic technologies that are currently covered include noninvasive prenatal detection of chromosomal abnormalities, such as found in Down syndrome.
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In 2009, the agency undertook a national coverage determination for pharmacogenomic testing to evaluate genetic tests predicting how a patient will respond to treatment with warfarin, a commonly prescribed anticoagulant.5 Aside from a fair number of meetings by the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine various genetic tests, "that's about the last you've heard from us on this topic," Jacques said.
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Medicare used a MEDCAC to review the evidence for the use of beta-amyloid PET imaging for diagnosis or treatment of dementia or neurodegenerative disease, Jacques said. While the review found that there was insufficient evidence for coverage, a decision was made to identify the status as CED for the purposes of excluding Alzheimer's disease in specific diagnoses and for the purpose of enriching clinical trials that addressed disease treatment and prevention strategies.7 Another example of evidence consideration was in the case of pharmacogenetic testing to predict patient response to warfarin.
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FACTORS THAT INFLUENCE COVERAGE DECISIONS In its coverage determination process, Medicare is required by law to consider public comments, Jacques said, and how persuasive those comments are depends on a variety of factors. For example, the clinical policy unit will not find thousands of form letters driven by interested stakeholders to be as convincing as a few well-considered public comments that point out, for instance, that an entire body of relevant evidence was omitted from the determination analysis.
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McDonough observed that Medicare and commercial payers have addressed similar challenges, such as handling different indications for cancer drugs by recognizing medications that are listed in certain published compendia. Similarly, he suggested, it is possible that a molecular diagnostics compendia could be created for which payers would recognize oncology markers identified in certain listings.
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From page 59... ...
McDonough observed that the CMTP effectiveness guidance documents for evidence standards recommend convening a multidisciplinary group of stakeholders to determine the preferred evidence-based decisionmaking process for certain classes of technologies. But, he added, "I don't think we can rely solely on expert opinion in making these decisions." If the expert opinion "is not really bounded by reliable evidence, then one really needs to question the validity of the expert opinion." What may be more important is the quality of the evidence; however, if stakeholders can agree on an evidentiary framework for assessing new genomic tests, that will make the process predictable, he noted.
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60 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS makes sense to do that -- "we need to find a better way to do CED." One possibility, he suggested, would be to have a voluntary process in which CED could "essentially be a default position for medical technologies that meet certain criteria." Test developers might be given, say, a 3-year grace period to establish sufficient evidence for full coverage approval. Such a system, he said, could motivate everybody to say, "Okay, we've got 3 years to get the answer on this.
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