Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review

Brace yourself—and your C-suite—for more sweeping legal changes.

Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of lab regulation stability—the Clinical Laboratory Improvements Act (CLIA). On Jan. 9, CMS posted a request for information (RFI) to let the industry know that it is conducting a full scale of review of CLIA requirements and asking for comments.

This is big news. And while CLIA review and reform will take months (if not years) to complete, lab compliance officers should waste no time in bringing it to the attention of their CEO and executive team. Here are the key points to cover in your briefing.

Backdrop
Remind the C-suiters that CLIA is the law that establishes the basic quality standards labs must meet to gain and retain CMS and state certification for diagnostic testing of human samples. Emphasize that the law was adopted in 1986 and hasn’t undergone significant changes since 1992. Now, after 36 years, CMS has decided to give CLIA a good hard look.

Legal changes can be scary, as the industry just learned with the ACA and PAMA. But CLIA review is something that the lab industry is bound to welcome. In fact, it’s been asking for such a review for years.

Significance & Scope of RFI
Explain that the new RFI is a kind of test balloon from CMS designed to start the process and begin the dialog. Describe how broad the scope of review is. Thus while the RFI proposes discrete and fairly narrow changes, it also invites comments on any and all other aspects of CLIA. In other words, CMS is at least prepared to listen to anybody who has a beef with CLIA and wants it changed.

The Proposed Changes
Now get into the substance of the RFI, the proposed changes. Explain that CMS is reviewing four broad aspects of CLIA and go through them one by one.

1. Personnel Requirements

The first area of review are the CLIA rules governing professional qualifications and other personnel issues. List the specific questions the CMS has posed for public comment:

• 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

Note that CMS is also looking into issues relating to violations of proficiency testing (PT) referrals. To start, explain that labs guilty of making intentional PT referral violations face 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

Continue the briefing by noting that the next focus area CMS is reviewing is current CLIA histocompatibility rules in light of advances in transplant medicine and lab testing. Specific issues for which the agency has requested comments:

• 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

Finally, explain that 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.

What Happens Next
Conclude your briefing with a projected timeline and explanation of what happens next. The key date to emphasize is March 9, 2018: That is the deadline to submit comments on the RFI. Once the comment period closes, CMS will have 90 days to prepare a Proposed Rule summarizing and responding to those comments and laying out a formal CLIA reform proposal.