Advocacy Update

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In This Issue:

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to adjust several proposed changes to the Medicare physician self-referral law, commonly referred to as the Stark law. The CAP is concerned that attempts to modernize the law may further incentivize providers to over-utilize services or create new opportunities for abusive self-referral arrangements that would hurt pathology practices. Additionally, while it is outside the scope of the changes proposed by the CMS, the CAP urged the agency to close the in-office ancillary services (IOAS) exception for anatomic pathology (AP) services.

On October 9, 2019, the CMS issued a proposed rule that would clarify regulations in the Stark law. While many of the changes reflect the CMS’s intent to allow greater flexibility to address certain value-based compensation arrangements, the CAP asked the CMS to support value-based arrangement exceptions with further safeguards. In the letter, the CAP supported “the CMS’s decision to exclude laboratories from the proposed value-based arrangement exceptions, best accomplished through including such a requirement in the individual exceptions at §411.357(aa).”

Further, the CMS suggested changes to the electronic health record (EHR) exception and a new cybersecurity exception. The CAP supported the continued exclusion of laboratories from these exceptions because of abusive practices and improper inducements reported by our members.

Finally, while not addressed by the CMS in the proposed rule, the CAP warned the Agency to close loopholes to deter abusive referral practices. “Even as the CMS has taken steps to close ambiguities to deter pod laboratories, and other abusive referral practices, physician groups are creating new arrangements to take advantage of the IOAS exception and profit from pathology services,” the CAP stated in its letter. “Our members report specialty groups building large ‘physician office’ AP laboratories serving broad geographic areas using contracted or part-time pathologists in a central location who are reimbursed at a fraction of the billed professional amount.” The CAP asked the CMS to exclude AP services from the IOAS exception, as it is the most effective means of preventing program abuses and protecting quality care for patients.

The CAP expressed similar concerns even before the proposed regulation’s release, and strongly encouraged the CMS to close the IOAS exception for AP services.

The CAP will provide updates on the final Stark law regulation.

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The CMS approved the Pathologists Quality Registry as a qualified clinical data registry for the fourth consecutive year. The CAP’s registry offers pathology practices a robust tool for complying with requirements under Medicare’s Quality Payment Program and Merit-Based Incentive Payment System (MIPS). Moreover, the CAP’s registry features quality measures and expert guidance, so pathologists get paid without further penalty by the Medicare program.

Not only does the CAP’s registry feature pathology-specific quality measures and expert guidance, but it also has the demonstrated ability to integrate with a practices’ laboratory information system or billing system for automated and simplified data collection.

As the CMS moves away from claims-based reporting for MIPS, it no longer allows practices of 16 or more pathologists to report quality measures on claims via a billing company. The CAP’s registry supports larger practices for their MIPS reporting and helps subspecialties, who may find it difficult to identify enough relevant quality measures for MIPS reporting, to maximize Medicare incentive payments. The CAP’s registry also supports smaller practices by providing multiple ways to submit quality data and by helping them demonstrate that some measures do not apply to their practice. By submitting data for the 2020 reporting period, MIPS eligible pathologists can avoid a 9% negative payment adjustment and potentially be eligible for a positive payment adjustment in Medicare Part B reimbursement in 2022.

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The CAP recently asked the Food and Drug Administration (FDA) to ensure that any guidance on emerging software as a medical device clearly assures pathologists’ important role in medical decision-making. This particular FDA draft guidance outlined clinical decision support products that would or would not require direct regulatory oversight from the agency.

In a December 26 letter to the FDA, the CAP asked for explanations on several issues, including the conflicting uses of the term "analyze" to describe conditions for the device definition, the use of bioinformatics software products being classed as devices, and the definition of a health care professional.

The CAP asked the FDA to further clarify on the criteria used to determine the applicability of regulatory requirements of clinical decision support, given the implications on laboratory information systems (LISs). For instance, the CAP asked the FDA to “clarify that [clinical decision support] is not a device if it uses data otherwise accessible to the provider and allows the provider to independently review the basis of the recommendation,” the letter said.

The CAP further educated the FDA on pathologists’ critical role in emerging digital health. Currently, LIS systems are exempted as medical software policy, and the CAP urged the agency to consider LISs as a non-software system since pathologists use it for their laboratory workflow. Having a strong definition of health care professionals as a physician or a practitioner defined by statute will ensure that oversight for LIS or clinical decision support products will include a physician and not need FDA oversight. The definition used by the FDA could potentially remove it from the exemption because laboratory technologists also access the LIS and, as stated by the guidance, would make it a device and require FDA oversight. Therefore, the use of a clear health care professional definition ensures that LIS systems would maintain their current regulatory status.

The CAP will continue to advise the FDA on its emerging regulatory paradigms and their impact on pathologists and laboratory medicine.

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The CMS announced a delay for clinical laboratory data reporting requirements under the Protecting Access to Medicare Act (PAMA) until 2021. PAMA requires applicable laboratories to report private payer rates for clinical laboratory services to the CMS, which then uses the data to calculate Medicare reimbursement rates for tests on the clinical laboratory fee schedule.

The CAP has advocated for improvements to PAMA to ensure more accurate reimbursement rates and continued access to laboratory tests for Medicare patients.

The 2020 government spending bill, and the inclusion of the Laboratory Access for Beneficiaries Act, delayed PAMA data reporting process from 2020 to 2021. The CMS then clarified on January 2 that PAMA laboratory data that was supposed to be reported between January 1, 2020, and March 31, 2020, must now be reported between January 1, 2021, and March 31, 2021.

Applicable laboratories must report data from the original PAMA data collection period of January 1, 2019, through June 30, 2019. Laboratory data reporting for these tests will resume on a three-year cycle, beginning in 2024. Also, statutory phase-in provisions were updated. For 2020, the rates for Clinical Diagnostic Laboratory Tests (CDLTs) that are not Advanced Diagnostic Laboratory Tests (ADLTs) or new CLDTs may not be reduced by more than 10% of the rates for 2019. There will be a 15% reduction cap for 2021, 2022, and 2023, as shown in the chart below.

CDLT Rates Based On Reporting Period Reduction Cap
2020 January 1, 2017 – May 30, 2017 10%
2021 January 1, 2017 – May 30, 2017 15%
2022 January 1, 2021 – March 31, 2021 15%
2023 January 1, 2021 – March 31, 2021 15%

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It just turned 2020 and already over 100 CAP members have registered for the 2020 Pathologists Leadership Summit. This is an exclusive opportunity for CAP members to elevate leadership skills, take action, and be more effective advocates for positive change—particularly now that the Spring House of Delegates Meeting and our annual Hill Day are also part of this event.

The Pathologists Leadership Summit will help you better manage your practice, achieve greater influence, and establish and maintain relationships with the legislators who make decisions that affect your specialty.

There is no fee to attend this event, and it includes CME credits. Spaces are limited—so you should register and lock in your course selections as soon as you can.

Visit for more information and help us set the path to a better future and register today.

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Check out January’s advocacy news quiz and join hundreds of your fellow CAP members to test your advocacy knowledge. Try sharing your results on social media to see who has the highest score. Take the quiz today.

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