WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical laboratories use to identify how patients metabolize many types of prescription drugs.
The federal government hand that giveth is the $215 million initiative announced by President Obama in January to foster the development of precision medicine. Government officials said that the National Institutes of Health and other departments would use the funds to generate the scientific evidence to move the concept of personalized medicine into clinical practice.
The federal government hand that taketh away on this matter is the Medicare program. Since last fall, the nation’s Medicare Administrative Contractors (MACs) have been discontinuing payment for pharmacogenomic testing that identifies how patients metabolize and respond to prescription drugs. As of June 22, all MACs had stopped paying for these tests. The last one, Noridian, ended payment for these tests on June 22.
“As many as 19 million Americans could be affected by this decision,” stated Kristine Ashcraft, Chief Operating Officer of Genelex, a pharmacogenomic testing company in Seattle, Washington. “That’s because about 75% of Americans have genetic variations affecting their response to medications. These medications are commonly prescribed drugs for patients with cardiovascular disease, pain, depression, anxiety, and cancer. When you consider that 4% of Medicare spending is for hospitalizations caused by adverse drug reactions, taking away coverage for tools that can help combat this problem is short-sighted.”
In its Local Coverage Determination (LCD) effective June 22, Noridian said it would end genetic testing to assess patients taking some medications and that for other medications, it would await definitive utility for such testing. In the LCD, Noridian said it ended payment for all genetic testing associated with all medications related to CYP2C9 (CPT 81227) and VKORC1 (CPT 81355). For genetic testing for medications related to CYP2C19 (CPT 81225) and CYP2D6 (CPT 81226), Noridian ended payment until definitive clinical utility is established. Testing for response to medications related to CYP2C19 and CYP2D6 would be limited for patients with certain indications, Noridian said.
“This decision is designed to save money at the expense of patient care,” said John Logan Black, III, M.D., Co-Director, Personalized Genomics Laboratory and Vice Chair for Business Development in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota. “It comes down to dollars and cents and not really what patients need,” he explained. “Medicare officials are trying to control costs by saying they haven’t seen enough benefit from these tests.
“However, it has long been considered that pharmacogenomic testing is the low-hanging fruit from the Human Genome Project, because these tests give us a lot of personalized information about patients,” he commented. “But now critics say it’s too hard to implement or insurers say they’re worried about the costs to implement this testing.”
Black pointed out that, even as Medicare ends or limits such coverage, the federal Food and Drug Administration recommends pharmacogenomic tests for medications. “Not only is such genetic testing recommended, but, in many cases, FDA clearance requires pharmaceutical companies to print those recommendations for genetic testing on the product information forms patients receive when prescribed these medications,” he explained.
“The FDA’s website shows the Table of Pharmacogenomic Biomarkers in Drug Labeling,” he continued. “This is a list of medications that pharmacogenomic biomarkers affect. These are biomarkers- meaning pharmacogenomic targets-that the FDA requires in drug labeling.
“On the list are a number of cytochrome P450s that require disclosure on drug labels as either cautionary, or, in some cases, the drug label contains information that says, basically, ‘If you’re going to use a specific dose, you (meaning the treating physician) should test this cytochrome P450.’ In some cases it says you should just test cytochrome P450 regardless of dosing,” he said.
Providers Caught in Middle
“So now what happens when Medicare payment doesn’t follow those recommendations?” Black asked. “It puts healthcare providers in a difficult position because-on one hand the FDA says, ‘You should test this patient’-and on the other hand, Medicare says, ‘We’re not going to pay for it.’ The patient gets caught squarely in the middle and may end up paying for that genetic test out-of-pocket. Or, if the patient decides not to be tested, then that patient may be at increased risk.
“The FDA is an important and reliable source of information on these biomarkers and how they interact with some of the most common medications,” continued Black. “But in addition to what the FDA says, the recommendations of the Clinical Pharmacogenetics Implementation Consortium should also be considered. CPIC publishes articles used to set practice guidance risk. This information is based on published literature.
“After looking over the literature, this committee evaluates the research on these various medications and biomarker studies and publishes practice guidance on the use of pharmacogenomic tests,” he stated.
“For issues in which clinicians need practice guidance, CPIC will put together a group of experts who write and publish a paper on the issue. For many of us, that paper then becomes the practice guidance for the use of pharmacogenomic tests in clinical practice.
“So once again, clinicians have a conundrum because these guidance documents are published, highly-regarded expert opinions,” emphasized Black. “Many of us in the field consider them to be the guidance documents for pharmacogenomics.
“So now this best-practice guidance is published and available to all,” said Black. “Therefore, I can envision a physician potentially being involved in litigation where the patient alleges that the physician didn’t follow what is considered ‘practice guidance’ in this area and the patient ended up with a horrible side effect. I’m not aware of any case like that, but it’s possible.”