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CMS Relaxes Rules Around COVID-19 Testing

Federal Insider: June 2020

The Centers for Medicare and Medicaid Services (CMS) continued its efforts to open up access for testing related to the novel coronavirus pandemic with a new set of waivers and rules around ordering and performing tests for COVID-19, the illness caused by the SARS-CoV-2 virus.

Notably, CMS will no longer require a written order from the treating physician or other practitioner for beneficiaries to get COVID-19 tests, nor for influenza tests meant to rule out other infections. The caveat: CMS still expects the person ordering the test to be authorized to do so under state law. Further complicating the picture, CMS rules also note that if a laboratory receives a test without a provider’s order, the performing laboratory must “directly notify the patient of the results consistent with other applicable laws, as well as meet other applicable test result reporting requirements.” In formulating policies around test ordering, laboratories will need to heed governors’ executive orders and other rules that dictate how tests can be ordered on a state-by-state basis.

CMS also now will pay hospitals and practitioners to assess beneficiaries and collect laboratory samples for COVID-19 testing under a separate payment when that is the only service a patient receives. In addition, CMS will cover antibody-based tests authorized by the Food and Drug Administration (FDA). For its part, FDA recently tightened policies around serological tests for COVID-19, requiring developers to obtain emergency use authorizations, submit their validation data within 10 business days, and meet new test performance thresholds, including 90% sensitivity and 95% specificity.

Other CMS rule changes include: an allowance for alternate specimen collection devices and media to collect and transport COVID-19 samples; permission for laboratories within a hospital campus to hold a single CLIA certificate for multiple laboratory sites, such as parking lot testing; payment for specimens a technician collects at a patient’s home, or for FDA-authorized self-collection kits used by the patient; and a clarification that pharmacists can both collect samples and, if their pharmacy has a CLIA license, perform certain tests.

NIH Launches $1.5 Billion Innovation Initiative for COVID-19 Diagnostics

The National Institutes of Health (NIH) announced a plan to speed development of tests for SARS-CoV-2 that will infuse $1.5 billion in federal stimulus funding into a new initiative called Rapid Acceleration of Diagnostics. The program aims to accelerate innovative technologies for rapid and widely accessible COVID-19 related testing, with the goal of making millions of accurate and easy-to-use tests per week available in the U.S. by the end of summer 2020.

NIH also said it will help move technologies more swiftly through the development pipeline toward commercialization. The plan calls for NIH to work closely with the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority.

According to NIH, the initiative will complement research currently underway that is focused on prevention and treatment of COVID-19, including the recently announced Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership to coordinate the international pandemic research response.

“We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development,” said NIH Director Francis Collins, MD, PhD.

Part of the new program will be competitive. NIH is asking scientists with rapid testing technology to enter a national COVID-19 testing challenge for a share of up to $500 million. The technologies will be put through a competition in a rapid, three-phase selection process to identify the best candidates for at-home or point-of-care tests for COVID-19. NIH will match finalists with technical, business, and manufacturing experts to increase the odds of success. If selected technologies are already relatively far along in development, NIH will put these on a separate track that focuses on rapid commercialization.