CHAMPion

Winter 2023

AMP Member Colleagues,

As a physician and pathologist who cares for my patients using molecular diagnostic tests, I have always been concerned with the proposals that sought to impose FDA regulation, in addition to the existing CLIA requirements, on our clinical laboratories. The VALID ACT is complex legislation that would have given FDA the authority to regulate all laboratory tests under a new framework. If passed it would have had a negative impact on patient care, public health, and diagnostic innovation. As detailed previously, the sponsors were seeking to pass the VALID Act as part of broad legislation introduced throughout 2022, most recently the US$1.7 Trillion omnibus appropriations package funding the federal government for the remainder of fiscal year 2023.

I am happy to report that on December 23^rd, 2022, Congress passed the omnibus bill without the inclusion of VALID! We should all share in the celebration of this major accomplishment! Thank you to all of you who lent your voice, sent letters, joined meetings with congressional offices, and supported our advocacy efforts. I greatly appreciate your efforts and am confident that it was your stories and perspective about the impact this legislation would have at your institutions and in your community that made all the difference.

While the VALID Act of 2022 has been defeated, Laboratory Developed Procedure (LDP) regulation will remain a prominent topic in the years ahead, and we believe that this long-standing conversation will continue. AMP will remain vigilant in 2023 and we stand committed to addressing any future attempts to implement flawed policies that would impact our ability to provide critical testing services using LDPs. In order for AMP to proactively influence the coming conversations, the Professional Relations Committee (PRC) is launching a Regulatory Reform Task Force with the main goal of updating and re-releasing AMP's CLIA Modernization proposal. As the Task Force develops the updated proposal, there will be many opportunities for the AMP membership at large to weigh in. Please keep an eye out over the coming year for future opportunities - we want to hear from you!

Again, thank you all for your hard work and efforts in advocating on behalf of the interests of molecular diagnostic professionals and the patients we serve.

Best,

Eric Konnick, MD, MS

Chair, AMP Professional Relations Committee

Omnibus Legislation Passes without VALID Act

On December 23, 2022, President Biden signed the long-awaited $1.7 trillion FY 2023 omnibus spending legislation. Despite a last-minute push for the Verifying Accurate Leading-edge IVCT Development (VALID) Act, the bill was not included in the final legislative package! Congressional staff had been working to update the bill and negotiate an exemption for LDPs performed by academic medical centers as many members of Congress earlier in the year expressed concern about how the legislation would impact patient care at these institutions. However, the exemption that was ultimately proposed was extremely narrow and no other changes were included to resolve the remaining significant concerns shared by many stakeholders, including AMP.

In response, AMP coordinated an advocacy effort that involved partnering with other organizations to meet with congressional offices in the final weeks of the year to express our concerns on how the FDA-centric framework would impact the ability of our members to practice medicine. Notably, our members also sent almost 800 emails in December alone to their elected officials in Congress expressing their concerns over the legislation! In total, AMP members have sent 1,547 letters to Congress expressing their concerns about VALID over the years. Thank you for taking the time to make your voices heard!

End-of-Year Legislation Included PAMA Delays

In addition to our major policy win regarding VALID, we would like to share some exciting news regarding the Protecting Access to Medicare Act (PAMA)! As a reminder, PAMA significantly revises the Medicare payment system for clinical diagnostic laboratory tests by requiring that Medicare payment for clinical laboratories be based on the weighted median of private payer rates along with a number of other provisions. Due to difficulties in the first reporting period, PAMA led to steep cuts to pricing such that reimbursement no longer reflects the effort or expertise required to perform the procedure. The omnibus legislation delayed PAMA reporting requirements and cuts to payments rates for one year, giving Congress additional time to discuss more comprehensive reform to how Medicare payment rates for clinical tests are determined. Furthermore, it revised the phase-in of payment reductions under the Medicare private payor-rate based Clinical Laboratory Fee Schedule (CLFS). The statutory phase-in of payment reductions was extended through calendar year (CY) 2026. There will be a 0.0 percent reduction for CY 2023, and payment may not be reduced by more than 15 percent for CYs 2024 through 2026.

While the reporting requirements and cuts to payment rates were delayed, broader reforms to PAMA were not included in the bill, including the Saving Access for Laboratory Services Act (SALSA). As a reminder, SALSA was introduced in June 2022 on a bipartisan, bicameral basis, and it would update the PAMA reporting requirements and create a sampling methodology for “widely available tests.” AMP has been supportive of SALSA and will continue to advocate for its reintroduction and passage in the 118^th Congress.

PREVENT Pandemics Act

In another positive turn of events, the omnibus legislative package also included many provisions from the PREVENT Pandemics Act on topics that have been advocacy focuses for AMP, including:

The Tracking Pathogen Act which directs the Department of Health and Human Services (HHS) to issue guidance to support collaboration relating to genomic sequencing of pathogens and the use of new innovative approaches and technology for the detection, characterization, and sequencing of pathogens to improve public health surveillance. It also authorizes the CDC to award grants to help with these efforts and gives the HHS Secretary the power to recognize centers of excellence to promote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emergency.
Provisions to improve recruitment and retention of the frontline public health workforce. These include allowing professionals with degrees in laboratory science to be eligible for the Public Health Workforce Loan Repayment Program. The bill also establishes the Bio-Preparedness Workforce Pilot Program to provide loan repayment for health professionals with expertise in infectious diseases and emergency preparedness and response.
A requirement that HHS make public policies and procedures related to public and private entities accessing specimens of pathogens to support research and development of medical countermeasures, such as tests. Additionally, this provision allows HHS to contract with public and private entities to improve the rapid development of diagnostic tests.
A requirement that FDA and other applicable agencies issue a report identifying best practices in pandemic response efforts for the development, issuance, and use of guidance documents and for communications with product sponsors and other stakeholders, and a plan for implementing such practices.
Finally, there was language included that requires the FDA’s Medical Device Advisory Committee to meet at least once a year through 2027 to provide FDA advice on topics related to medical devices in pandemic preparedness and response, including issues related to diagnostics. This provision also requires the Government Accountability Office to report on the program for third-party review of 510(k) premarket notifications for medical devices.

Telehealth Extension

Also related to lessons learned from the COVID-19 pandemic, the legislative package included an extension for numerous telehealth regulatory flexibilities through December 31, 2024. This allows Congress additional time to develop legislation on permanent solutions to support reimbursement of telehealth services if the public health emergency were to end. The flexibilities extended include the removal of geographic requirements, expansion of originating sites, and reimbursement of audio-only telehealth services under Medicare. Telehealth is an important issue to AMP and our membership. On September 13^th, 2022 AMP signed onto a letter urging for the extension of telehealth flexibilities so we are extremely pleased with this progress. AMP will continue to monitor news on telehealth and activity on the hill.

Thank You and Looking Forward

From everyone at AMP we would like to say thank you for your continued passion to improving the practice of molecular pathology and access to patient care. It was a tremendously successful end to the year and AMP looks forward to continued engagement with Congress and the Administration on issues that are of high priority to our members. As always, we will continue to present opportunities for our members to be involved in these important issues! We have a number of new and exciting projects under development that we look forward to sharing with you all soon. Furthermore, always feel free to bring any issues or topics that you believe that the AMP Policy and Advocacy Team, the Professional Relations Committee, and the Economic Affairs Committee should take focus on. You can contact the Policy Team at policy@amp.org. Here is to another successful year!