Advocacy Update

• Bipartisan, Bicameral LDT Oversight Legislation Is Reintroduced in Congress
• CAP Advocates for Patient Access for CAR T-Cell Services and Funds for Residency Slots
• Last Week to Take June News Quiz!
• Editor’s Note: Next CAP Advocacy Update is July 13

On June 24, Sens. Richard Burr (R-NC) and Michael Bennet (D-CO), and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) introduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, which would provide regulatory oversight of laboratory-developed tests if enacted into law. The CAP had engaged with the VALID Act’s sponsors and other stakeholders to suggest improvements to the bill over the last year. The CAP remains engaged, will review the latest version of the bill, and provide its feedback to the sponsors of the VALID Act.

“As the leader in laboratory quality and improvement programs, the CAP is committed to excellence in the practice of pathology and ensuring patient access to high-quality tests. The CAP appreciates the efforts of Sens. Burr and Bennet, and Reps. DeGette and Bucshon to solicit broad input from multiple stakeholders to produce the bipartisan, bicameral VALID Act,” said CAP President Patrick Godbey, MD, FCAP, following the reintroduction of the legislation. “This bill continues to move in the right direction and provides the most viable legislative pathway to reaching a consensus on the oversight of laboratory-developed tests. A legislative approach to oversight of LDTs must leverage existing processes to maintain safe and reliable testing for patients today without stifling innovation of future tests.”

The bill's legislative sponsors said VALID Act would establish a new, risk-based framework for the review and approval of LDTs that would accelerate innovation and improve the quality of testing. The legislation seeks to clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), and limit duplication between the two agencies, the lawmakers said.

“In the operating room, time is a precious commodity – even the smallest delay can be the difference between life or death for a patient,” said Rep. Bucshon, who is a cardiothoracic surgeon. “Recent advancements in diagnostic testing technology have transformed the speed and accuracy in which doctors receive this life-changing information, giving patients and doctors what they need most: more time. The VALID Act makes sure that a safe, accurate, and risk-based framework is in place to allow leading edge development and innovation to thrive in our hospitals and laboratories, while assuring doctors and patients that their test results are analytically and clinically valid.”

The CAP urged the CMS to increase 2022 hospital inpatient service reimbursements and graduate medical education funding. The CAP asked the CMS to use 2020 data when determining reimbursement rates for CAR T-cell services. Additionally, the CAP requested that the CMS increase funding for medical residency positions, including those in rural hospitals, and advocated for additional pathology slots.

In a June 28 letter, the CAP outlined its concerns and requests for the proposed 2022 Medicare Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal Year 2022 Rates. The CAP is supportive of the CMS’ proposals to increase payments for CAR T-cell therapies and related services, but the CAP warned that the rates are still insufficient to cover these expensive therapies. Current reimbursement rates are too low for the services, which leads to limited access to critical life-saving care for patients. The CAP urged the CMS to use 2020 Medicare data when determining reimbursement rates for 2022.

“With its increased use, CAR-T-cell therapy is an expensive evolving service that presents unique challenges for providers, patients, and the CMS. The resource consumption and clinical characteristics of the patients with a given set of conditions are clinically distinct from others. It is also difficult to predict what the costs associated with other future CAR-T therapies will be – there will likely be new or different side effects or additional agents that are co-administered with the therapy with the potential to increase toxicity. The CAP urges the CMS to take these issues into account...”

More Medicare Funding Needed for Residency Programs

The CAP also urged that the CMS increase funding for medical residency positions as the country faces a shortage in medical doctors. The CMS has proposed to implement several provisions of the Consolidated Appropriations Act of 2021, including a requirement for 1,000 new Medicare-funded medical residency positions. Beginning in fiscal year 2023, a phase-in of 200 positions will be added each year for five years. The CAP supported the increased Medicare-funded medical residency positions for all medical specialties to help ease current physician shortages and bolster the foundation of our health care system.

The US health system still has access to care issues, especially in rural and other communities where shortages exist. The CAP said the CMS should prioritize residence slots accordingly. The CAP supports the “prioritization of residency positions based on Health Professional Shortage Areas and urges the agency to consider funding additional medical residency positions in pathology as it is one medical specialty that is often overlooked and experiencing shortages, especially in rural areas.”

The CAP will engage with the CMS and will provide updates periodically.

It’s the last week of June and the last week to test your Advocacy news knowledge. Last month, over 90 pathologists took the quiz. See how you compare against your fellow CAP members in the June News Quiz and brag about your top scores on social!

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Your Advocacy Update newsletter will take a scheduled break on July 6 due to the Independence Day holiday. For more immediate updates, please check out our Twitter feed @CAPDCAdvocacy.