Genetic testing is one of the most cutting edge fields in the healthcare industry. However, there are obstacles that prevent it from being widely available to patients.
Recently fifteen members of Congress sent a letter to Secretary of Health and Human Services (HHS) Tom Price and Chairman of the Medicare Payment Advisory Commission (MedPAC) Francis Crosson to request government assistance in expanding patient access to genetic testing.
Congressional healthcare wish-list includes research and analysis of genetic testing impact
The congressional letter requests that HHS and MedPAC initiate studies to determine how the government might further the availability of genetic testing for patients. Specifically, the congressmen and congresswomen ask that the HHS collaborate with the National Academy of Medicine to accomplish the following goals:
- explore how genetic testing might boost preventive healthcare and precision medicine;
- assess how genetic testing can contribute to a reduction in general healthcare expenditures;
- come up with suggestions on ways the government can promote diagnostic, predictive, presymptomatic genetic testing, as well as whole genome sequencing; boost genetic testing in the workforce (through training and an increased number of genetic counselors); and buttress the creation of a body of evidence that demonstrates the usefulness of genetic testing.
MedPAC asked to look into CMS coverage determinations regarding genetic testing
In addition, the congressional appeal asks that MedPAC initiate its own study in order to:
- make suggestions on ways the Centers for Medicare and Medicaid Services (CMS) can tailor coverage protocols that take into account treatments involving precision medicine;
- study the financial impact genetic testing would have on the government (in terms of reduced healthcare expenditures);
- explore the possibility that the Medicare and Medicaid coverage protocols as they stand now might be limiting genetic testing in certain instances.
Letter asks the federal government to do more
The letter acknowledges the “nearly limitless opportunities to implement better diagnosis and treatment methods, enhance patient outcomes, and reduce health care costs” that technologies developed through genomics research have afforded the healthcare industry. It also applauds the government for the recently passed 21st Century Cures Act and the ongoing funding for the Precision Medicine Initiative and Cancer Moonshot, examples of the government demonstrating its commitment to “medical innovation.”
However, the letter wouldn’t be an appeal if it didn’t point to where certain lacks exist.
The request describes the reality of many patients finding themselves locked out of the most cutting-edge medical treatments or diagnostic tools associated with genetic testing simply because their healthcare policies do not allow it (including coverage under Medicare and Medicaid). And when coverage does exist, obstacles like long wait periods and pre-approval requirements for genetic counseling often preclude patients from obtaining testing, or else get in the way of them comprehending the test results themselves and how those results might direct beneficial courses of treatment.
The members of Congress concede that many insurers are reluctant to pay for genetic testing in the absence of a “significant amount of data and their clinical utility.” But the letter further asserts the reality that genetic testing will not be considered a mainstream healthcare tool without greater insurance coverage. And the catch-22 corollary: the data that insurers seek is likely to continue to remain un-gathered as long as genetic testing is relatively infrequently used due to insurance exclusions.
This blog post is provided for educational purposes only and is not offered as, and should not be relied on as, legal advice. Any individual or entity reading this information should consult an attorney for their particular situation. For more information/questions regarding any legal matters, please email [email protected] or call 310.203.2800.