House, Senate Act on CLIA PT Referral Bills

The House passed legislation giving CMS flexibility in enforcing sanctions on clinical laboratories for violating proficiency testing (PT) referral rules. The Senate Health, Education, Labor, and Pensions Committee reported out a companion bill. Both bills would revise the PT referral rules under CLIA. Currently, CMS interprets these rules strictly, saying that it must revoke an offending lab’s CLIA certificate for one year and bar the owner or operator from running another lab for two years, even if the referrals are inadvertent or needed for confirmatory testing. The bills would give CMS discretion, where warranted, to make the one-year revocation optional rather than mandatory and substitute intermediate sanctions in place of the two-year ban on lab ownership or operation.