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Mr. WAXMAN. Mr. Speaker, 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.
Current law does not allow the Secretary any flexibility in imposing these penalties for labs that improperly refer proficiency tests--even for an unintentional referral.
Equally importantly, there have been a number of changes in the organization and delivery of health care since these penalties provisions were enacted. In particular--the growth of health systems that have many providers joining together to operate under the same umbrella. In the case of laboratories, one hospital system may own and operate a number of labs. If one lab is found to have a proficiency testing violation, all of the labs under the hospital's system would be barred from Medicare--even if those labs had no quality or proficiency testing issues.
This is not a sensible result. This legislation would address that problem.
First, H.R. 6118 ensures the statute is clear on the point that no proficiency testing sample may be referred to another laboratory even if such referral would be part of the testing lab's standard procedure for patient specimens (a point of existing law on which some providers have been confused).
Second, it grants the Secretary discretion in determining whether to revoke a lab's CLIA certificate for improper referrals of PT testing samples--to account for the case of unintentional error.
Finally, the bill would grant the Secretary discretion to apply alternate sanctions in lieu of the 2-year owner/operator ban if a CLIA certificate has been revoked due to an improper proficiency testing referral, correcting the problem of having to ban all labs in a health system, even if the others had no known problems.
The Taking Essential Steps for Testing Act would address that issue, striking a balance to ensure quality protections remain, yet giving the Secretary the flexibility to more appropriately tailor penalties for violations of the law. I'm pleased to support this bill today.
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