Advocacy Update

• CAP, Patient, and Health Industry Groups Urge Congress to Include VALID Act in FDA Bill
• WHO Declares Monkeypox a Global Health Emergency
• PAMA Lawsuit Supported by the CAP Wins Appeal
• CAP Asks Congress to Increase GME Funding
• AMA Amends Model Prior Authorization Legislation Per CAP’s Request on ‘Gold Card’ Practice
• In Case You Missed It: CAP Update on LDTs and the VALID Act Webinar
• Proposed 2023 Medicare Payment Regulations Webinar
• Test Your CAP Advocacy Knowledge

In a letter to Congress on July 20th, the CAP and nearly 50 organizations representing physicians, patient advocates, and health care industry have asked Congress to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act’s in the FDA user fee reauthorization bill as key lawmakers negotiate a final version of the legislation.

Signatories on the letter to support the advancing the VALID Act as part of the pending FDA User Fee legislation included the American Society of Clinical Oncology (ASCO), American Cancer Society Cancer Action Network, BD (Beckton, Dickson and Co.), Bio-Rad Laboratories, Center for Science in the Public Interest, Cepheid, Friends of Cancer Research, Hologic, Muscular Dystrophy Association, Ovarian Cancer Research Alliance, Pew Charitable Trusts, and Roche Diagnostics.

The VALID Act is a bipartisan, bicameral bill that would create a new comprehensive regulatory framework for clinical laboratory tests that includes laboratory-developed tests (LDTs). Members of Congress in the House and Senate are currently trying to strike an agreement on the overall FDA user fee package. The Senate Committee on Health, Education, Labor, and Pensions (HELP) had included the VALID Act in its version of the FDA bill.

“As Congress finalizes a legislative package reauthorizing FDA’s user fee programs, it can also seize this truly unique opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests,” the letter said. “We appreciate your continued support for meaningful diagnostics reform, and we remain committed to working with you and the committees to advance this legislation into law this year.”

Read the full letter to congressional leaders.

The World Health Organization announced the multi-country outbreak of monkeypox is a Public Health Emergency of International Concern on July 23. The declaration should compel countries to implement strategies aimed at stopping the outbreak, which has increased rapidly over recent weeks.

Globally, there are nearly 17,000 confirmed cases of monkeypox from 75 countries. In the United States, there were 2,891 monkeypox cases as of July 22, according to the Centers for Disease Control and Prevention. Cases are confirmed in all states except Alaska, Maine, Mississippi, Montana, Vermont, and Wyoming.

FDA Updates Laboratories on Monkeypox Swab Specimen Guidance

The Food and Drug Administration (FDA) advised laboratories testing for monkeypox to use swab specimens taken directly from a lesion (rash or growth) when testing for the virus. The FDA is unaware of clinical data supporting the use of other types of specimens (such as blood or saliva) for monkeypox virus testing. Therefore, testing these other types of specimens may lead to false results.

For more information, please review the FDA safety communication.

A US Court of Appeals ruled in favor of a motion in a lawsuit by the American Clinical Laboratory Association (ACLA) against the Department of Health and Human Services (HHS) over how fees for clinical laboratory services are calculated. The judgement sought to correctly implement market-based reforms to clinical laboratory fees mandated by the Protecting Access to Medicare Act (PAMA) of 2016. The CAP has strongly supported ACLA’s lawsuit against the HHS and efforts to correct the administration’s execution of PAMA’s clinical laboratory payment reforms.

The court agreed that the 2016 PAMA regulations were arbitrary and capricious, which is an argument that the CAP made in an amicus brief in support of ACLA’s lawsuit in 2018. Now the case will head back to the DC District Court.

The CAP disagreed with the final PAMA regulation that determined how Medicare would decide what to pay for diagnostic tests performed in clinical laboratories. The rates would be based on private payer fees, which was reported by applicable laboratories to the government through a data collection process.

The appeals court ruling stated that the government, without adequate explanation, exempted a sizable portion of the laboratories covered by the statute from the data reporting requirement. “Indeed, only 21 hospital laboratories—out of a total of 1,942 reporting laboratories—reported their data, even though hospital laboratories accounted for nearly a quarter of Medicare payments made under the Clinical Laboratory Fee Schedule in 2015.”

The CAP and over 70 other medical professional and educational groups asked Congress to increase Medicare funding for graduate medical education (GME) in the upcoming budget reconciliation legislation. The CAP has long advocated for an increase funding to support more GME residency slots, which is key to addressing critical shortages of pathologists in the coming years.

In the July 18 letter to congressional leadership, the CAP and the coalition outlined how the COVID-19 pandemic is burning out the US medical workforce. In the letter, the group discussed how the US “is facing a shortage of up to 124,000 physicians by 2034, which is almost certain to be exacerbated by an aging physician population, rising rates of physician burnout, and early retirement due to the COVID-19 pandemic.” The coalition understands that the lack of physicians will hurt patients the most, especially in underserved areas. They strongly urged Congress to ensure patient access to care, improve provider diversity and health equity, and prepare for the next public health crisis by investing more in physician training.

The CAP has consistently asked legislators to increase GME funding to increase residency slots, which is key to addressing critical shortages of pathologists in the coming years.

The American Medical Association (AMA)’s Council on Legislation approved the CAP’s amendment to the AMA’s model prior authorization legislation. The CAP worked with AMA staff to advocate for a payment safeguard containing a prior authorization “gold card” to void any adverse financial impacts to pathologists and physicians involved in the rendering of a service.

The CAP asked the AMA to include an enhanced payment safeguard to extend protection to pathologists and clinical laboratories involved in the rendering of a health care service. The CAP encourages health insurance carriers not to limit or deny payment to a physician or laboratory that provides a service based on whether the ordering physician has utilized or failed to utilize a laboratory benefit management program.

In 2021, Texas enacted the first gold carding law in the nation with a payment safeguard to protect qualified providers from denials or reductions in payment when granted a prior authorization requirement.

The CAP has been actively monitoring states pursuing prior authorization gold-cards, which exempt qualified providers from prior authorization requirements who demonstrate a high degree of performance and adherence to evidence-based medicine. This year, the CAP advocated on this issue in Colorado and California and will continue to partner with state pathology societies and state medical associations to ensure adequate protection to payment for services that are subject to any gold-card waiver.

The CAP’s amendment will protect pathologists and clinical laboratories from unnecessary payment denials and reductions as states look to advance the model legislation.

In case you missed the CAP’s Update on LDTs and the VALID Act Webinar, you can watch the recording to get the latest information on congressional efforts to enact legislation for a new comprehensive regulatory framework for laboratory-developed tests (LDTs). During this webinar, CAP leadership reviewed the key components of the Verifying Accurate Leading-edge IVCT Development (VALID) Act and how it would affect laboratories and pathologists if it is enacted into law.

Watch the recording

On Monday, August 8 at 1 PM ET/ 12 PM CT, the CAP will offer this complimentary live webinar where CAP experts will review proposed regulatory changes that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Join us for a deep dive into the proposed 2023 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS).

Webinar presenters will be the Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Economic Affairs Committee Chair Stephen Black-Schaffer, MD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Diana Cardona, MD, FCAP.

Register now

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