I am pleased that we are taking up H.R. 6118, a bipartisan, non-controversial bill that will provide the Centers for Medicare & Medicaid Services (CMS) with additional flexibility in imposing and enforcing penalties on clinical laboratories under the Public Health Service Act. The Committee on Energy and Commerce has a long history of being vigilant with respect to quality and safety standards for clinical laboratories. In fact, the Public Health Service Act standards for labs originated in this Committee when John Dingell, Ed Madigan, Ron Wyden and I sponsored the legislation in the 1980's. All laboratories in the United States must be certified and meet certain quality and safety standards. To maintain certification, laboratories must periodically perform proficiency tests, which measure the quality of a lab's work. These proficiency tests must be performed in-house--as the test is intended to measure that specific lab's quality and competency. If a lab is found to have intentionally referred a proficiency testing sample to another laboratory, the Secretary of HHS must revoke that lab's CLIA certificate for at least 1 year (thereby preventing it from billing Medicare or Medicaid for that period). In addition, the owner or operator of any lab that has had its CLIA certificate revoked is barred from owning or operating any CLIA-certified laboratory for 2 years.…
On the recordSeptember 19, 2012
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