Advocacy Update

• CAP Outlines Concerns Regarding LDT Oversight with FDA
• Bipartisan Effort Urges HHS to Implement No Surprises Law Provisions Supported by the CAP
• GME Advocacy Coalition Ask President, Congressional Leaders to Support Medicine in Infrastructure Bills
• Attention Laboratories: FDA Extra COVID-19 Testing Supplies Exchange Program
• Last Week for the May News Quiz!
• Editor’s Note: Next CAP Advocacy Update is June 8

CAP leaders met with top officials from the US Food and Drug Administration (FDA) to detail its concerns about the oversight of laboratory-developed tests (LDTs) on May 20. The CAP’s representatives specifically addressed provisions in the bipartisan, bicameral LDT oversight legislation, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020. At present, the CAP believes the VALID Act is the only viable LDT-oversight bill currently being debated in Washington and the CAP’ has sought to improve the legislation. The CAP offered its insights on LDTs and practical issues surrounding the regulation of these tests in its meeting with the FDA.

Representing the CAP were President Patrick Godbey, MD, FCAP; Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Council on Scientific Affairs Chair Raouf Nakhleh, MD, FCAP; Council on Accreditation Chair Richard Scanlan, MD, FCAP; and CGPA Vice-Chair Joe Saad, MD, FCAP.

Representing the FDA from the Office of the Center were Director Jeff Shuren, Deputy Director for Policy Ellen Flannery, Associate Director for Scientific & Regulatory Programs Elizabeth Hillebrenner, Senior Policy Advisory Brittany Schuck, and Senior Policy Advisor Davina Marano; from the Office of the Chief Counsel were Associate Chief Counsel Marcy Busch and Associate Chief Counsel Sara Beardsley; and from the Office of In Vitro Diagnostics and Radiological Health were Director Timothy Stenzel, Director Personalized Medicine Wendy Rubinstein, Associate Director for Regulatory Programs Toby Lowe, Personalized Medicine Policy Analyst Kristofor Langlais, Personalized Medicine Staff Fellow McKenna Tennant, Associate Director, Guidance, Legislation & Special Projects Eli Tomar, and Senior Policy Advisor Jennifer Tomasello.

Since 2009, the CAP has advocated for a three-tiered, risk-based approach for LDT oversight that leverages a public-private partnership and a targeted role for the FDA.

The CAP has not taken a position on the VALID Act, but the last version of the bill had moved in a positive direction by focusing on the specific issue of LDT oversight and not overreaching to other areas extraneous to this issue. The CAP has advocated that the VALID Act offer flexibility and not be too prescriptive.

The CAP has opposed another bill, Verified Innovative Testing in American Laboratories Act of 2020, concerning LDT oversight led by Sen. Rand Paul, MD (R-KY). Sen. Paul’s legislation is not a viable proposal and lacks support in Congress.

The CAP will remain engaged with the FDA and the sponsors of the VALID Act to advocate for a streamlined, nimbler, and less burdensome approach to LDT oversight.

A bipartisan effort from Reps. Larry Bucshon, MD, (R-IN) and Raul Ruiz, MD, (D-CA) and Sens. Bill Cassidy, MD, and Maggie Hassan (D-NH) have urged the administration to ensure that the No Surprises Act is implemented as Congress intended and aligns with policy positions supported by the CAP. The No Surprises Act, which included provisions advocated for by the CAP, ends the practice of surprise medical bills.

Reps. Buschon and Ruiz and Sens. Cassidy and Hassan inquired about how the new law will be implemented in a May 5 letter to Department of Health and Human Services Secretary Xavier Becerra, Department of Labor Secretary Martin Walsh, and Department of Treasury Secretary Janet Yellen. The lawmakers have sought to ensure that the government does not institute federal rate-setting and takes a balanced approach when considering arbitration factors during the dispute resolution process.

“We ask the Administration to refrain from issuing guidance or taking other action that would give preference to one factor over the other as it works to promulgate rules for the No Surprises Act,” Reps. Buschon and Ruiz said.

“The inclusion of the arbitration factors related to prior contract history and good faith efforts will show how the parties engaged prior to Congressional intervention, so as to disincentivize either party from using the process as leverage to alter rates.”

The federal lawmakers and the CAP are concerned that focused consideration on the median in-network rates could become a de facto benchmark that could spur providers to cancel contracts, which happened in states that relied only on in-network rates.

Since the bill was signed into law, the CAP has engaged in the rulemaking process to ensure appropriate implementation that will hold patients harmless, establish a fair reimbursement formula for services provided, deny insurers the ability to dictate payment, create an independent dispute resolution (IDR) process that pathologists can participate in, and require network adequacy standards for health insurers. The CAP expects regulatory proposals will be released over the next few months as the law takes effect January 1, 2022.

The Graduate Medical Education Advocacy Coalition (the Coalition), made of almost 60 medical and health groups, including the CAP, asked President Biden and congressional leadership in the House and Senate for increased federal support for physician training in upcoming legislative infrastructure bills. The CAP strongly supports any federal effort to boost funding for graduate medical education (GME).

In the May 18 letter, the Coalition said, “Physicians are a vital part of our health care infrastructure, and it is critical that we train more in order to meet the needs of our diverse and growing nation, ensure patient access to care, and prepare for the next public health crisis.

“The United States is facing a shortage of between 54,100 and 139,000 physicians by 2033 – a dearth that is almost certain to be exacerbated by rising rates of physician burnout and early retirement due to the COVID-19 pandemic.” A shortage would be devasting for patient access, especially in rural communities nationwide.

The coalition, which includes the American Medical Association, the Association of American Medical Colleges, the American College of Obstetricians and Gynecologists, and the American College Surgeons, discussed how Congress recently provided 1,000 new Medicare-supported GME positions in the Consolidated Appropriations Act of 2021, which the CAP supported. However, more is needed to increase the number of physicians substantially.

The vast majority of GME funding comes from the federal Medicare program. The Medicare program pays for direct GME – costs of educating residents – and indirect medical education to cover the higher costs of teaching hospitals. Resident physicians who graduate from medical school typically spend three to seven years in GME training at teaching hospitals and their associated outpatient settings.

On May 17, the FDA announced a volunteer laboratory supplies exchange program for COVID-19 testing supplies for those laboratories that need or have extra testing supplies. The FDA announced the COVID-19 laboratory testing supplies exchange on a Centers for Disease Control and Prevention (CDC) COVID-19 response call where Council on Government and Professional Affairs Vice Chair Assad Joe Saad, MD, FCAP, participated on behalf of the CAP.

The goal of the supply exchange is to provide an easy way for organizations to either ask for additional supplies, including tests or also surplus items not needed for themselves for others.

Organizations will be responsible for shipping and logistics related to the exchange. If COVID-19 tests were received as a gift from your state or the HHS, they should not be sold. The CDC is awaiting further guidance from the HHS Office of General Counsel regarding registering tests from gift programs without compensation.

A recent CAP survey of board-certified pathologists nationwide showed that less than half, or 45% of laboratories testing for COVID-19, still have difficulties obtaining the testing supplies they need. While this represents an improvement since last summer, shortages still represent a significant burden on those laboratories diagnosing coronavirus disease and require national attention to mitigate disruptions.

Laboratories should go to http://tiny.cc/SupplyExchange and complete the form, including the number and type of test kits needed/surplus if supplying or requests tests and submitting the form. This is a voluntary program with no compensation for participation.

It’s the last week to take the May news quiz. Already over 70 pathologists have taken the quiz. See how you compare against your fellow CAP members’ in the May News Quiz.

Take the news quiz

Your Advocacy Update newsletter will take a scheduled break on June 1 due to the Memorial Day holiday. For more immediate updates, please check out our Twitter feed @CAPDCAdvocacy.