Advocacy Update

• Congress Addresses Key CAP Priorities in Omnibus Bill
• ICYMI - CMS Delayed Enforcement of GFE Requirements
• Final Weeks to Test Your Advocacy Prowess in 2022
• Breaking Advocacy News: Check out the Advocacy Twitter Channel
• Editor’s Note: Next CAP Advocacy Update is January 10

In its 2023 federal funding legislation, Congress mitigated next year’s scheduled Medicare cuts to physicians, delayed implementation of pending cuts to clinical laboratory fees, and included a bill championed by the CAP to ensure the nation is prepared for future pandemics. The legislation did not include some other measures which the CAP asked Congress to adopt.

As Congress faced a December 23 deadline to avoid a government shutdown, several lawmakers called for a smaller legislative package in the weeks following the November elections as a new Congress will gavel into session after January 1. However, Congress acted on most of the CAP’s priorities in its year-end spending bill. The bill was released earlier on December 20 and Congress will work to pass it over the next few days.

Reducing Medicare Cuts in 2023 and 2024

A strong lobbying effort by the CAP and a coalition of physician groups led by the American Medical Association (AMA) successfully convinced Congress to mitigate Medicare cuts in 2023. The CAP and the physician groups lobbied lawmakers to prevent the entire 4.5% Medicare cut stemming from the program’s policy to increase payment for evaluation and management services. The CAP, for example, had been lobbying Congress to stop this cut since the CAP’s Hill Day in May. Congress opted to mitigate the cut by 2.5 percentage points in 2023. Congress also mitigated the same Medicare cuts in 2024 by 1.5 percentage points. As a result, the CAP estimates that the average Medicare spending impact on pathology will be a -1.1%, based on an anticipated reduction of -3.6% projected for 2023 prior to the congressional action.

"The CAP is pleased that Congress did pass critical legislation to prevent future pandemics and mitigate the impact of Medicare cuts for 2023, but we are still disappointed that Congress didn’t avert the entire cut facing pathologists and other physicians. Unfortunately, this issue will continue to threaten access to high-quality patient care,” said CAP President Emily E. Volk, MD, FCAP.

Congress also extended incentive payments for participating in eligible alternative payment models paid by Medicare.

Delay in Medicare CLFS Cuts

Congress decided to not pass the Saving Access to Laboratory Services Act (SALSA). The bill would stop a 15% Medicare cut to laboratory fees, reduce administrative burden on laboratories, and ensure accurate collection of private market data through statistically valid sampling from all laboratory segments. Instead, Congress decided to delay cuts that were set to take effect in 2023 by one year. Reporting requirements, where certain applicable laboratories must send the Centers for Medicare & Medicaid Services data on private payer rates for clinical laboratory services, were also delayed by one year.

PREVENT Pandemics Act to Become Law

Also during the CAP’s Hill Day, pathologists asked Congress to support public health emergency legislation by passing the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). Key elements of the act include

• expanded genomic sequencing and advanced molecular detection,
• enhancing public health surveillance of pathogens – particularly through the Advanced Molecular Detection program,
• improving recruitment and retention of the public health workforce,
• and modernizing the supply chain for vital medical products.

VALID Act Not Included

The CAP also supported the Verifying Accurate Leading-edge IVCT Development (VALID) Act in order to ensure quality laboratory testing for patients and minimize the regulatory burden on laboratories, while allowing for continued innovation in laboratory testing. While lawmakers couldn’t reach an agreement to include the VALID Act in the omnibus legislation, the Food and Drug Administration (FDA) is expected to step in to fill the void. FDA Commissioner Robert Califf, MD, and Jeff Shuren, MD, the director of the FDA Center for Devices and Radiological Health, recently stated publicly that if Congress could not come to agreement on a legislative solution that the FDA would use its current authority to regulate laboratory-developed tests in the absence of a newly enacted statute.

Congress Promotes Diversity in Clinical Trials

Congress added provisions to the Omnibus bill that are intended to increase diversity in clinical trials. These provisions include requiring the Secretary of Health and Human Services to issue or revise guidance on:

• promoting diversity in clinical trials via diversity action plans,
• the use of decentralized clinical studies,
• modernizing clinical trials via the use of new digital health technologies, and
• promoting the seamless and concurrent expansion of clinical trials to better capture evidence on a variety of patients.

The CAP Board of Governors recently adopted new policy promoting clinical trial diversity.

The new provisions also require the Secretary to facilitate public workshops for various audiences including patients, academia, and clinical researchers to bolster understanding of the importance of diversity in clinical trials and related best practices.

Earlier in December, the Centers for Medicare & Medicaid Services (CMS) announced it delayed the enforcement of the good faith estimate (GFE) requirements for uninsured and self-pay individuals. The CMS released a FAQ stating that the Department of Health and Human Services (HHS) extended 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.

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 of expected charges.

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Your Advocacy Update newsletter will take a scheduled break for the New Year’s holiday. The next issue will be on January 10, 2023. For more immediate updates, please check out our Twitter feed @CAPDCAdvocacy.