Senate Passes TEST Act; Measure Heads to President

Legislation giving CMS leeway in enforcing sanction on clinical laboratories for violating proficiency testing (PT) referral rules was approved by the Senate Nov. 14 and now heads to the president for his signature. The Taking Essential Steps for Testing (TEST) Act (H.R. 6118; S. 3391) passed the House in September. The measure amends the Public Health Service Act to revise sanctions for clinical laboratories that unintentionally refer PT samples to other laboratories. It allows CMS discretion to make the one-year certificate revocation for such a laboratory optional rather than mandatory and the flexibility to levy intermediate sanctions instead of the two-year prohibition against ownership or operation of a lab. Under current law, CMS has maintained that it has no choice but to revoke a lab’s certificate and invoke the two-year prohibition, even in cases of unintentional referral.