CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look

“May you live in interesting times.”

If you’ve been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very “interesting” year for the industry. After nearly four decades of stability, Medicare is moving to the new supposedly market-based PAMA fee schedule for Part B lab tests. And now we are learning that things are about to get “interesting” for another rock of lab regulatory stability—the Clinical Laboratory Improvements Act (CLIA).

But unlike with PAMA, the CLIA “interesting” promises positive results for the industry.

The Backdrop

CLIA is the 1986 law that establishes the basic quality standards labs must meet to gain and retain CMS and state certification for diagnostic testing of human samples. And it has not undergone changes since 1992.

The CMS Proposal

With that in mind, CMS posted a request for information (RFI) on January 9 to let the industry know that it is reviewing CLIA requirements and asking the industry for comments.

What’s on the Table

CMS is reviewing four broad aspects of CLIA:

1. Personnel Requirements

The RFI calls for public comments on the following questions related to professional qualifications and other personnel issues:

• Should a bachelor’s degree in nursing be considered equivalent to a bachelor’s degree in biological science or a qualifying degree to meet CLIA requirements for moderate and high complexity testing personnel and technical consultants?

• Should a physical science degree be a CLIA qualification requirement and, if so, how should such a degree be defined?

• Which, if any non-traditional degrees should be considered as meeting current CLIA requirements for chemical, physical, biological or clinical lab science and/or medical lab technology degrees?

• Should general supervisors be allowed to perform competency assessment for personnel performing moderate complexity testing in labs that perform both moderate and high complexity testing?

• What lab training, experience and skills should all personnel be required to meet and how should those things be properly documented?

2. Proficiency Testing Referrals

Labs guilty of making intention proficiency testing (PT) referrals face automatic an automatic two-year CLIA revocation. But the 2012 TEST Act (Taking Essential Steps for Testing Act) gives CMS discretion to impose alternative penalties based on the nature and extent of the PT referral. The RFI raises questions on how the agency should use its TEST Act discretion, namely:

• Should the discretion apply to a case where a lab is found to have referred its PT samples to another lab and reported that other lab’s PT results as its own and, if so, under what conditions?

• Is it feasible to impose alternative sanctions in cases of PT referrals involving waived testing?

3. Histocompatibility Requirements

CMS is reviewing current CLIA histocompatibility rules in light of advances in transplant medicine and lab testing. Specific issues under consideration:

• Should virtual crossmatching in lieu of physical crosswalking be allowed for transplantation? If so, what criteria and decision algorithms should be used for virtual crossmatching?

• Should current CMS-3326-NC20 histocompatibility regulations be revised or totally eliminated given obsolescence and redundancy with other CLIA regulations?

4. CLIA Fees

The other issue on the table are current CLIA fees, specifically the current methods used by CMS to determine fees it charges labs:

• For seeking a revised CLIA certificate due to changes in the lab’s name, location, director, services or certification type;

• For determination of program compliance?

• As additional fees based on type and/or volume of testing performed and other criteria CMS deems appropriate; and

• For performing other CLIA compliance performance activities such as follow-up visits, complaint investigations and activities associated with imposition of sanctions.

Nothing Is Exempt from Review

If you have a beef with some other aspect of CLIA, you’ll be happy to know that the RFI states that in addition to the above areas, CMS is open to comments on any aspect of CLIA that needs changing.

What Happens Next

CMS will field comments on the RFI through March 9. It will then have 90 days to prepare a Proposed Rule summarizing and responding to those comments.

Takeaway: Although there has been no official response as of yet, the lab industry is bound to embrace CLIA review—in fact, it’s something the industry has wanted for over a decade.