FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

February 5, 2024By Steven J. Gonzalez & Gail H. Javitt & Allyson B. Mullen

On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). That CMS teamed up with its sister agency to support FDA’s proposed rule is itself unusual.  More surprising still is CMS’ unabashed declaration of its own lack of “expertise to assure that tests work,” given CMS has for decades been responsible for implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and, according to CMS’s own 2006 CLIA fact sheet, “has primary responsibility under CLIA for regulating laboratories.”

Indeed, as the fact sheet explains, Congress enacted CLIA following reports of inaccurate Pap smear results intended to detect cervical cancer precisely to ensure the “accuracy and reliability of all laboratory testing.”  Under this paradigm, only laboratories certified by CMS (or a deemed accrediting body) may perform clinical testing services.  To obtain certification, laboratories must comply with regulatory requirements relating to personnel qualification and training, record keeping, quality control, and proficiency testing, and must maintain a quality assurance and quality control program adequate to ensure the validity and reliability of the laboratory examinations. CLIA-certified laboratories are subject to inspections by CMS (or a CMS-approved accreditation organization) to confirm that the testing complies with CLIA regulations, including that there is adequate validation of the tests, supervision by the laboratory director and quality procedures in place.

The joint press release largely repeats, and has CMS endorse, the arguments FDA has previously made in support of its proposed rule, which we rebut in the detailed comments we filed on behalf of a coalition of laboratories. The two agencies are similarly aligned in their opposition to suggestions that “concerns with LDTs should be addressed through expansion of CLIA.” Many have read this as a deliberate swipe at an alternative, legislative pathway for CLIA modernization proposed by the Association for Molecular Pathology and supported by a diverse group of stakeholders.  The joint press release counters that “this is not the answer,” and alleges that “establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies.”

There is great irony in the agencies’ professed concern for increasing bureaucracy.  In a case of the pot calling the kettle black, FDA has no stated plan of how it will address its exponentially increasing workload should it finalize its proposed LDT rule. FDA estimates that the proposed rule would increase the volume of device premarket submissions it receives up to twenty-fold in a single year and that the volume would, on an ongoing basis, be at levels at least twice as high as FDA currently manages. FDA will need to hire (and train) significant volumes of new personnel to manage these new submissions just as CMS may need to hire (and train) additional personnel if its authority is significantly expanded. And while FDA suggests in the proposed rule that review of LDT applications could be outsourced to third-party reviewers (which is entirely unrealistic given the program’s history), the suggestion of needing outside help simply underscores that FDA does not believe that it currently has the personnel it needs to regulate LDTs.

The press release also fails to consider other pathways to address the agencies’ concerns about LDTs. Some states, like New York, require separate licensure of laboratories and premarket review of certain tests, including review of clinical validation data, to perform LDTs on specimens from the state. We are unaware of FDA having expressed that New York State’s validation requirements are inadequate, and New York State approval is not accompanied by the myriad other FDA requirements for medical devices that FDA’s proposed rule would impose on labs (e.g., Medical Device Reporting, Quality System Regulation compliance, and reporting of corrections and removals).

The joint press release provides support for the adage that “opposites attract”; FDA claims broad authority to regulate LDTs notwithstanding its lack of statutory authority under the Federal Food, Drug, and Cosmetic Act, while CMS disavows the clear authority over clinical laboratory testing with which it has long been imbued under CLIA.