Which law mandates regulations on all facilities where patient testing is performed?

In this Issue:

CAP Asks CLIAC to Consider Oversight for Nontraditional Laboratory Testing

With the significant increase in the number of nontraditional testing sites since the COVID pandemic, the CAP has urged the Centers for Medicare & Medicaid Services (CMS) to consider the optimal oversight for nontraditional testing sites and point of care testing (POCT). Regardless of where any of the test components are performed, laboratories should observe good laboratory practices throughout the total testing process. In addition, a new category of testing personnel should be considered for individuals that use POCT devices as a support function to their primary roles and have no formal laboratory training.

The CAP provided its testimony and recommendations on nontraditional testing sites during an April 14 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), which provides recommendations to the CMS on CLIA regulations. Other nontraditional sites that are increasing include distributive testing sites. The CAP asserted that all aspects of clinical laboratory testing performed in a distributive testing model should be regulated under CLIA, including bioinformatics and cloud-based software computing. The CAP further urged CLIAC to recognize bioinformatics facilities (including stand-alone facilities) as subject to CLIA, add personnel requirements for bioinformaticists, and revamp proficiency testing (PT) requirements to test the total testing process.

Finally, there was significant interest in the so-called remote testing waiver that was borne from the pandemic. Although a change in this would require a change in regulations, CLIAC discussed the many considerations needed in any future regulations. While the CAP sees the benefits in continuing to allow remote work for clinical laboratory personnel, the CAP encouraged CLIAC to explore the risks and impacts on clinical laboratory operations and patient care if the remote work waiver is made a permanent practice for clinical laboratories.

Joe Saad, MD, FCAP, Vice-Chair of the CAP’s Council of Government and Professional Affairs, provided the testimony supporting the CLIAC’s efforts to examine the CLIA regulations to determine modifications to ensure the regulations accommodate advancements in clinical laboratory practice. Dr. Saad stated, “since the inception of CLIA, non-traditional testing sites have exploded across the range of CLIA specialties and subspecialties. Therefore, the CLIA regulations should be updated by adding personnel requirements for point-of-care-testing, recognizing bioinformatics (including stand-alone facilities) as subject to CLIA, adding personnel requirements for bioinformaticists, revamping proficiency testing requirements to test the total testing process, and considerations for remote work.”

While the CAP encouraged CLIAC to consider recommendations to ensure the regulations accommodate advancements in clinical practice, the CAP also indicated that “any modifications should assure patient access to quality testing by affording the least burdensome approach to oversight.”

CMS Releases IDR Chart, Other No Surprises Act Resources

On April 12, the CMS released additional guidance on the No Surprises Act, including a chart for the Independent Resolution (IDR) Process, FAQs surrounding the new surprise billing requirements, and requirements related to providing good faith estimates. The CAP had urged Congress to hold patients harmless from bills for out-of-network services provided at in-network hospitals or facilities and now engages with the administration on the implementation of the No Surprises Act.

As part of additional guidance regarding the No Surprises Act, the CMS released a high-level chart that helps determine whether the federal IDR process or the state process applies in a particular state. Under the No Surprises Act, a state law on balance billing will still apply unless the federal law provides further protection.

Additional CMS No Surprises Act guidance outlines how providers and health care facilities must publicly disclose patient protections against balance billing. According to the new guidance, providers must also give a good faith estimate of expected charges to uninsured or self-pay patients at least three business days before a scheduled service (or upon request).

Over 30 Laboratory Groups Demand CMS Cover NGS Testing for Patients

The CAP and over 30 other medical laboratory health organizations asked the CMS not to remove over 100 diagnostic codes from national coverage determination for Next-Generation Sequencing (NGS) as it will impact critical patient care. The CAP had advocated for NGS Medicare coverage for patients with advanced cancer.

In the April 6 letter, the groups outlined how removing these codes will also remove critical coverage for “genomic testing for a significant number of patients with advanced cancer and likely result in tens of thousands of inappropriately denied Medicare Part B and Part C claims.”

In 2018, the CMS finalized the national coverage for NGS-based genetic testing for patients with advanced cancer, enabling access to comprehensive genetic testing for cancer treatments. NGS-based testing has become a valuable tool in cancer treatment protocols.

However, in the final 2022 In-Patient Payment System regulation, the CMS left out numerous cancer ICD-10 NGS codes from designation changes to not discourage their use in the in-patient setting. The CMS created confusion for coverage of Medicare cancer patients, delaying critical life-saving care.

The CAP will remain engaged with the CMS on this coverage issue.

Advocacy Win: Kentucky Pathologists-CAP Amended Test Results Law Enacted

On April 8, Kentucky State House Bill 529 was enacted, without Gov. Andy Beshear’s signature, displacing the information blocking requirements of the federal 21st Century Cures Act for certain test results and pathology reports. The Kentucky Society of Pathology (KSP), the CAP, and the Kentucky Medical Association (KMA) successfully amended the legislation to address pathologist concerns with the initial bill. The CAP worked to safeguard pathologists and laboratories from federal legal risks under the Cures Act considered to be information blocking, resulting from delay in the release of diagnostic testing results to patients.

The new law mandates certain pathology reports and test results to be withheld for 72-hours before patients can access the result in the electronic health record to mitigate the risk of potential emotional distress to patients, pending patient conferral with the ordering physician.

Specifically, the KSP, the CAP, and the KMA worked together to remove legal and operational non-compliance risk to pathologists and clinical laboratories by placing the state legal obligation of withholding certain clinical laboratory and pathology test results and reports exclusively on the entities or persons who control the electronic health record.

The law took effect upon enactment.

Only Two Weeks Left to Register for the Pathologists Leadership Summit

With free registration for CAP members and the ability to earn up to 7.75 CME, you still have time to register to attend the 2022 Pathologists Leadership Summit and strengthen your influence while making a bigger difference for our profession.

Worried you can’t take time away from your practice? No problem—whether you make the trip to our nation’s capital or stay at home, you can still make an impact by educating legislators on the value we deliver and our impact on patient care.

All sessions will be recorded, so if you are unable to attend, as a registered member you will still have full access and the ability to claim free CME once the meeting ends.

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