Thursday, June 25, 2020

HHS Issues FAQ On How Recent Laws Impact COVID Testing and Insurance

On June 16, I published a short blog that "COVID Test Pricing Hits Headlines."   For example, (1) even members of Congress were getting erroneous bills for COVID testing, while (2) some unscrupulous labs had hit out of network payers with $6000 bills for a single COVID test.  Here

(Update: A 2nd article, June 29, NYT, on $6000 COVID tests, here.).

New news on June 25:

HHS has released a new 18 page FAQ on CARES implementation.   
  • See the NEW HHS FAQ, 18 pages, June 23, here.  
    • Note this is "FAQ PART 43".
  • See coverage at MedTechDive here.
  • HealthcareDive here.  Quadax blog here.
While the coverage under CARES is for both PCR (or other molecular method) testing and antibody testing, HHS clarifies that workplace employment testing is not covered.


A few key points from the 18 page FAQ.  Note, my bullet points below are very brief summaries and do not substitute for the FAQ.
  • Does it cover self insured plans? Yes.
  • What tests are covered?  Basically, FDA EUA tests (with some extra cases).
  • What is a covered test that is: "medically appropriate [per] attending health care provider."  At least, an individualized health assessment by the ordering health care provider.
  • At home testing covered?  Yes.
  • Workplace surveillance covered?  No.
  • Is more than one test covered by law?  Yes, in principle.
  • If a facility fee is provided, it also has no copay.
  • Other COVID diagnostics like CT scan not covered by this law.
  • Statute generally precludes balance billing for lab test.
  • Statute has out of network billing rules but state laws may interact (Q10, Q11).
  • The second half of the FAQ (Q13ff) discusses other topics such as telemedicine under COVID law.

Medicare has separately worded coverage, which occurred in its second interim final rulemaking on COVID.   There, we have COVID molecular testing covered for Medicare patients suspected of having COVID disease (also covered is RSV and influenza testing in the same patients).  And Medicare covers serology testing for COVID, by means of regulation updated at 42 CFR 410.32, in patients who "have had or are suspected to have had" COVID.  And Medicare lets any state-legal health care personnel to order the test, not just the treating physician.

See additional news at LEX from Squire Patton Boggs here.
For a June 22 article on the lab industry providing workplace tests, here.
The first 12 page HHS FAQ about CARES implementation is stil lonline, dated April 11 (here).  This was FAQ PART 42 and remains largely in effect but with some details "superseded" by FAQ 43.