Advocacy Update

• CAP Lobbies Congress to Include Pathology Priorities in Year-End Legislation
• CMS Further Delays Enforcement of Good Faith Estimate Requirements
• ICYMI - Coming Reimbursement Opportunities for Digital Pathology Webinar
• ICYMI - Impact of the 2023 Final Fee Schedule on Your Practice Webinar
• Test Your Advocacy Prowess with the December News Quiz

As Congress negotiates year-end legislation, the CAP is urging lawmakers to prevent scheduled Medicare cuts in 2023 and protect Medicare payment for clinical laboratory fees before December 31. The CAP is also actively advocating for policies that prepare the country for future pandemics and to protect provisions in legislation providing guardrails on the federal oversight of laboratory tests.

Fighting Against Scheduled 2023 Medicare Cuts

The CAP continues to lobby against the scheduled impending Medicare cuts. Absent congressional action, pathologists will face a 3.64% cut to all pathology services in 2023. However, Congress is expected to mitigate the 2023 cut as it has for similar cuts in recent years. The CAP conducted a virtual fly-in with 48 CAP members meeting with 60 congressional offices to discuss this issue.

The CAP and a coalition of medical professional organizations have also asked senators to sign a letter as a strong show of support to prevent 2023 Medicare cuts from going into effect. In October, the CAP and over 100 medical and health groups asked members of the House of Representatives to cosponsor the Supporting Medicare Providers Act of 2022 (HR 8800), which aims to stop the upcoming Medicare reimbursement cuts in 2023 and provides guidance to improve the Medicare Payment system for physicians.

SALSA Act

Another piece of legislation the CAP is lobbying to pass Congress is the bipartisan and bicameral Saving Access to Laboratory Services Act (SALSA). The CAP and 25 other organizations asked congressional leaders to protect payment for clinical laboratory services by supporting SALSA.

A coalition letter supports reforms on how the Centers for Medicare & Medicaid Services (CMS) collects data from laboratories and stops next year’s 15% payment cut to more than 800 clinical laboratory tests. The CAP has long expressed concern about PAMA’s burdensome reporting requirements and the CMS’ failure to include such a large portion of the laboratory market in payment reporting, resulting in skewing PAMA payment rates.

PREVENT Pandemics Act

The CAP and its members have continued to manage the impact of COVID-19 on their laboratories. Therefore, the CAP strongly urged Congress to support the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) and Pandemics Act, which would strengthen the nation’s public health, medical preparedness, and response systems in the wake of the COVID-19 pandemic. For example, $175 million would be allocated to expand genomic sequencing and advanced molecular detection, and $750 million would fund efforts to modernize the medical supply chain.

VALID Act

In addition, the CAP wants to protect the provisions in pending legislation providing flexibility to laboratories that also ensure patient access to new and innovative tests. In September, Congress did not include the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the Food and Drug Administration (FDA) user fee reauthorization bill. While Congress had reauthorized FDA programs and user fees for the next five years, some provisions were only reextended to mid-December 2022. Congress is seeking to reauthorize those items and add other policies, such as the VALID Act. The CAP wants to protect those provisions in the VALID Act that place guardrails on the FDA and offer flexibility for laboratories.

On December 2, the CMS published an FAQ announcing that the agency further delayed enforcement of the good faith estimate (GFE) requirements for uninsured or self-pay individuals. The FAQ clarified that the Department of Health and Human Services (HHS) is extending enforcement discretion, pending future rulemaking, for situations where GFEs for uninsured (or self-pay) individuals do not include expected charges from co-providers or co-facilities. According to the HHS, they have received feedback that “compliance with this provision is likely not possible by January 1, 2023, given the complexities involved.” Importantly, they explain that any rulemaking to fully implement the GFE requirements related to uninsured (or self-pay) individuals will include a prospective applicability date that gives providers and facilities a reasonable amount of time to comply with any new requirements.

The GFE requirements were included in the No Surprises Act and intended to protect uninsured (or self-pay) individuals from unexpectedly high medical bills. When a physician/facility schedules an item or service (such as a medical device, a doctor’s visit, or a surgical procedure), it must determine the individual’s health insurance status. If the patient has no coverage (uninsured) or does not intend to submit a claim to the plan/coverage (self-pay), the physician/facility must provide notification to the patient of the good faith estimate (GFE) of expected charges.

In March of 2022, the CAP met with the CMS to try and obtain clarification and further guidance around these requirements. As we expressed in an April 2022 letter, “we see no clear way to proceed in providing prospectively reliable estimates for pathology services, as pathologists are not the initiator of the tissue or fluids submitted for diagnosis, and will know neither what will be submitted nor what will need to be done until the pathologist has reviewed the original specimen(s) from each individual patient.”

For more information, check out the FAQs.

On December 2, the CAP hosted a webinar to specifically address new digital pathology CPT codes. These codes will be available for pathologists to report starting January 1, 2023.

Check out the recording

On November 1, the CMS released the final 2023 Medicare payment regulations, including the final Medicare Physician Fee Schedule and the Quality Payment Program regulations.

On Monday, December 5, the CAP offered a complementary live webinar where CAP experts reviewed final regulations that will impact 2023 Medicare payment for services and pathologists’ participation in the quality initiatives.

Watch the recording

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