Advocacy Update

• Congress Introduces Bipartisan Legislation to Increase GME Funding
• CAP Applauds Congress for Introducing SALSA to Protect Patient’s Access to Lab Tests
• VALID Act Reintroduced in Congress
• CAP Asks HELP Committee to Standardize Laboratory Reporting in Pandemic and All-Hazards Preparedness Act
• The CAP Applauds Bipartisan International Medical Graduate Legislation
• FDA Issues Transition Plan for COVID-19 Emergency Use Authorizations
• New Month- New News Quiz

On March 29, Reps. Terri Sewell (D-AL) and Brian Fitzpatrick (R-PA) introduced the bipartisan Resident Physician Shortage Reduction Act of 2023. This legislation would combat the nation’s physician shortage and improve access to health care by expanding the number of Medicare-supported medical residency positions by 14,000 over seven years. The CAP has long advocated for increased funding to support more GME residency slots, which is essential to addressing critical shortages of pathologists in the coming years and is one of the 2023 Advocacy asks.

Medicare pays for direct GME, the costs of educating residents, and indirect medical education to cover the generally higher costs teaching hospitals to incur. Congress made a critical initial investment in the physician workforce by providing 1,000 new Medicare-supported GME positions in the Consolidated Appropriations Act of 2021, the first increase of its kind in nearly twenty-five years.

The United States is facing a shortage of up to 124,000 physicians, according to a recent study from the Association of American Medical Colleges (AAMC). This is exacerbated by an aging physician population, rising rates of physician burnout, and early retirement due to the COVID-19 pandemic.

The demand for trained pathologists exceeds the supply provided by the number of existing residency positions. For example, the CAP’s 2021 Practice Leader Survey data suggests a nationwide demand of 1,000-1,200 pathologists to fill open positions in the United States in recent years. However, these numbers are substantially lower than the demand reported for 2022.

In contrast, over the last decade or so, approximately 620 pathologist residency positions have been available each year. However, of those pathologists that complete residency, not all go on to practice full-time due to various reasons, including some opting to pursue research or go into the industry rather than clinical practice and others being international medical graduates (IMGs) that rely on J-1 visas. In 2022, 33.3% of first-year pathology resident slots were non-US IMGs.

On March 29, Congress introduced the bipartisan, bicameral Saving Access to Laboratory Services Act (SALSA; S. 1000/H.R. 2377), which would update Medicare’s payment system for clinical diagnostic laboratory services, protect patient access to critical laboratory services, and strengthen infrastructure in clinical laboratories. The bill was introduced by Sens. Sherrod Brown (D-OH) and Thom Tillis (R-NC), and Reps. Richard Hudson (R-NC), Gus Bilirakis (R-FL), Scott Peters (D-CA), Brian Fitzpatrick (R-PA), and Bill Pascrell (D-NJ). The CAP has long advocated that Congress protect payment for clinical laboratory services by supporting the bipartisan and bicameral Saving Access to Laboratory Services Act.

SALSA would address the CAP’s concerns with clinical laboratory payment rates that were put in place by the Protecting Access to Medicare Act (PAMA) in 2014. SALSA will reduce the administrative burden on laboratories and ensure accurate collection of private market data through statistically valid sampling from all laboratory segments while avoiding drastic cuts to clinical laboratory payment rates. This will allow laboratories to focus on providing timely, high quality clinical laboratory services for patients, continuing to innovate, and building the infrastructure necessary to protect public health.

Congress has intervened on a bipartisan basis four times to delay the next Medicare clinical laboratory fee schedule (CLFS) reporting periods and three times to delay cuts to maintain access to lab services for patients. Absent congressional action, payment for about 800 tests will be cut up to 15 percent in January 2024.

Collectively, these cuts may threaten access to laboratory services, and they would come as clinical laboratories across the country face continued workforce shortages and inflationary pressure on costs.

The CAP has long expressed concern about PAMA’s burdensome reporting requirements and the Centers for Medicare and Medicaid Services’ failure to include such a large portion of the laboratory market in payment reporting, resulting in skewed PAMA payment rates. Because of this, the CAP is happy to see SALSA reintroduced.

The CAP appreciates the leadership of House Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) for reintroducing the Verifying Accurate, Leading-edge IVCT Development (VALID) Act on March 29. The CAP supported the VALID Act in the last Congress, but lawmakers were unable to reach a consensus on moving forward with the bill.

The CAP believes with the recent change in congressional leadership, increased partisan division, and shifts in priorities make it even less likely Congress will be able to reach a consensus on laboratory-developed test (LDT) reform in the next two years. The CAP expects the next move on LDTs to come from the Food and Drug Administration which has previously stated it would initiate rule making if Congress did not act.

The CAP provided its input to the Senate Health, Education, Labor, and Pensions (HELP) Committee leadership on reauthorizing the Pandemic and All-Hazards Preparedness Act. Specifically, the CAP asked the HELP Committee to establish minimum national data reporting requirements for which clinical laboratories would be required to report in the state they are located, among other standardizing and funding requests. The CAP has supported improvements to national testing and pandemic response strategy.

In the March 29 letter to HELP Committee leadership, the CAP outlined how COVID-19 highlighted critical areas of concern that must be addressed to better prepare for future pandemics and offered recommendations for consideration during the pandemic and preparedness act’s reauthorization. Those policies include:

• Standardization of electronic laboratory reporting;
• Authorization of funding to enhance lab information systems;
• Strengthen the supply chain;
• Ensure a mechanism for adequate coverage and reimbursement of tests during a public health emergency; and
• Authorize funding to strengthen the laboratory workforce.

The CAP will continue to work with the Committee on this legislation.

The CAP applauds Senators Amy Klobuchar (MN-D) and Susan Collins (ME-R) for reintroducing the Conrad State 30 and Physician Access Reauthorization Act (S. 665), which would reauthorize the Conrad 30 waiver program for three years, make improvements to the program, and increase the number of waivers granted to each state. This program incentivizes qualified international medical graduates (IMGs) to serve in underserved communities and is critical to help address the physician workforce shortage. The CAP continues to advocate to increase the physician workforce to maintain patient access to quality health care.

The United States is facing a shortage of up to 124,000 physicians by 2034. In the March 31 letter to Senators Klobuchar and Collins, the CAP outlined how “IMGs are an important part of our nation’s health care system and currently represent 25% of the physician workforce. The percentage of first-year pathology resident slots were non-US IMGs was 33.3% in 2022 and 30.1% in 2023 …Under current law, J-1 visas require IMGs to return to their country of origin for at least two years upon completion of their residency, unless a Conrad 30 waiver is obtained.” This two-year requirement unnecessarily burdens the US medical workforce by placing strain on the hiring process after investing resources to train these IMGs.

The bipartisan Conrad 30 waiver program allows IMGs to work in underserved communities. Once the IMGs agree to the terms of the Conrad 30 program, they will not have to leave for two years before they are eligible to apply for an immigrant visa or permanent residence. The CAP will advocate for Congress to advance this important legislation.

The Food & Drug Administration (FDA) issued two guidance documents for COVID-19 medical and testing devices after the expiration of the public health emergency declaration in May. The first guidance is for Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, and the second is Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).

Transition Plan for Enforcement Policies

The first guidance establishes a 180-day transition period. After November 7, the FDA will only allow for the distribution of medical devices used during the public health emergency if they are under FDA regulatory review or the manufacturers intend to stop distribution. The March 2023 transition plan for medical devices under the enforcement policy applies to digital pathology devices used in remote reviewing and reporting digital pathology slides. The enforcement policy entitled, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, allowed for the use of digital pathology devices such as automated digital image manual interpretation microscopes, whole slide imaging systems, digital pathology image viewing and management software, and digital pathology displays.

Therefore, clinical laboratories can continue using these devices before August 2023 if the device is (1) restored to an FDA-cleared or approved version or (2) an electronic copy of the updated labeling accurately describes the product features and regulatory status.

Transition Plan for EUAs

The FDA developed this guidance as a transition plan for emergency use authorizations issued during the emergency declaration. The guidance outlines the FDA’s transition plan for medical devices, including laboratory-developed tests (LDTs), related to coronavirus disease 2019.

Clinical laboratories can continue using the authorized devices while it is under FDA review. For LDTs, the FDA intends to exercise enforcement discretion as it does with other LDTs. Manufacturers are required to have a communications plan for clinical laboratories, but the FDA will review information available publicly. The FDA will also classify emergency use authorization devices as part of this regulatory review. For devices no longer available for distribution, the FDA will allow these clinical tests to remain on the market if the device is:

1. Restored to an FDA-cleared or approved version; or
2. An electronic copy of the updated labeling accurately describes the product features and regulatory status (eg, the product lacks FDA clearance, approval, or authorization).

It’s April and that means a new News Quiz! Test your knowledge with the April Advocacy News Quiz. See how you compare against your fellow CAP members and brag about your top scores on social!

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