CONGRESSWOMAN ELISE STEFANIK
On Wednesday, September 19, the House is scheduled to consider H.R. 6118, the Taking Essential Steps for Testing Act of 2012, under a suspension of the rules, requiring a two-thirds majority vote for passage. This legislation was introduced by Rep. Michael Grimm (R-NY) on July 12, 2012, and referred to the House Energy and Commerce Health Subcommittee, which held a markup and approved the legislation by voice vote on September 11, 2012.
The Taking Essential Steps for Testing Act of 2012 would amend Section 353 of the Public Health Service Act to revise sanctions for clinical laboratories that unintentionally refer proficiency testing (PT) samples to other laboratories. The legislation would allow the Secretary of Health and Human Services (HHS) 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.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). According to the Subcommittee on Health, labs are also required to do periodic proficiency testing (PT) in order to maintain their CLIA certification. PT testing requires a lab to adhere to CMS procedures for processing samples, share its testing results with CMS, and it is prohibited from intentionally referring that sample to any other lab. Currently, CMS is required to revoke the CLEA certificate of any laboratory that intentionally refers its proficiency testing samples to another laboratory for testing for a period of one year. In addition, any person who has owned or operated a laboratory which has had its CLIA certification revoked may not own or operate a laboratory for a period of two years following such revocation.
H.R. 6118 would allow CMS discretion to consider the circumstances under which a PT sample was referred to another lab and address the laboratory accordingly.
There was no Congressional Budget Office (CBO) cost estimate available for this bill.