Advocacy Update

• CAP Urges Significant Changes to FDA Proposed LDT Rule to Lessen Regulatory Burden on Laboratories
• CAP Names New Vice President of Policy and Advocacy
• CAP Urges Pathologists to Contact Legislators to Stop Medicare Cuts Before the End of 2023
• Legislation Introduced to Protect Physicians and Patients from Electronic Payment Transaction Fees
• Foreign Medical Graduates Waiver Program Extended to February 2
• In Case you Missed it: 2024 Medicare Physician Fee Schedule Final Rule Webinar Recording
• Take Our News Quiz for December

Citing substantial undue regulatory burdens and costs on laboratories, the College of American Pathologists (CAP) called on the US Food and Drug Administration (FDA) to make significant changes to its proposed regulation of laboratory-developed tests (LDTs) in a letter to the FDA on December 4.

“As physician specialists in the diagnosis of disease, pathologists have a long history of delivering high-quality pathology and clinical laboratory services to patients,” said CAP President Donald Karcher, MD, FCAP. “For more than a decade, the CAP has advocated for an LDT oversight framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists and laboratories. The FDA must strike the right balance of protecting the public without overburdening laboratories to the point where they can no longer offer highly accurate LDTs. The CAP and its members urge the FDA to ensure laboratories can meet any new requirements without interfering with patient care and stifling the innovation of future testing.”

The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify over the course of five years in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk to patients.

In its comments to the FDA, the CAP recommended that the following categories of the proposed rulemaking should continue under the FDA’s enforcement discretion policies:

• Exempting tests offered prior to the rule’s enactment
• Forensic, Human Leukocyte Antigen (HLA), and manual tests
• LDTs developed and offered locally by a clinical laboratory
• Adverse events reporting
• Quality systems
• Corrective action and removal
• Labeling

The continuation of enforcement discretion policy in these areas would contribute significantly to the continued advancement of medicine and clinical care for patients, the CAP said. The CAP also made several recommendations to the FDA, including a call to convene public hearings to determine test risk classification and solicit input on an ongoing basis to advise officials on appropriately classifying tests. The FDA should also conduct comprehensive educational campaigns for laboratories on new requirements before enforcing adherence to new rules. Finally, the CAP strongly urged the FDA to provide more opportunities for public and stakeholder input before finalizing the proposed rule and proceeding with its subsequent phases.

Read the CAP’s full comment letter to the FDA.

On December 1, Kristin L. McDonald joined the College of American Pathologists as vice president of Policy and Advocacy. Ms. McDonald will oversee Legislation and Political Action, Economic and Regulatory Affairs, Quality, Policy Roundtable, and Executive Operations for the CAP’s Washington, DC office and will be a member of the Executive Operations team.

Ms. McDonald joins the CAP from the American College of Surgeons where she worked for 13 years, most recently as Chief of Legislative and Political Affairs. She previously served as Director, Congressional Affairs for the American Society of Clinical Oncology and as Deputy Director for the American Psychiatric Association. She also worked on Capitol Hill as a legislative assistant for former Rep. Deborah Pryce (R-OH) in addition to a stint with a law firm specializing in health care.

A Chicago native who grew up in Michigan, Ms. McDonald received her bachelor’s degree in political science and international studies from Northwestern University in Evanston, IL. Read more.

The CAP extends its gratitude to John Scott for an extraordinary 25 years of service advocating for pathologists as Vice President of Policy and Advocacy. He retires from the organization on January 2.

The CAP is urging members to act by contacting their members of Congress to ask them to sign on to a Dear Colleague letter being circulated by Reps. Mariannette Miller Meeks, MD (R-IA); Ami Bera, MD (D-CA); Larry Bucshon, MD (R-IN); and Kim Schrier, MD (D-WA) to House and Senate leadership asking them to quickly provide relief and financial stability before physicians face payment reductions in 2024 stemming from budget neutrality requirements within the 2024 Medicare Physician Fee Schedule.

In a November 16 letter to House and Senate leadership, over 100 national medical specialty and state medical associations, including the CAP, urged Congress to prioritize legislative action to stop Medicare payment reductions before the end of the year.

CAP members can ask their congressional representatives and senators to sign onto the letter before Tuesday, December 12. Take action now!

Rep. Greg Murphy, MD (R-NC) and a bipartisan group of lawmakers in Congress introduced this No Fees for EFTs Act that would eliminate fees charged to physicians for receiving payment electronically. Insurers routinely require doctors to pay as much as 5% if they want to be reimbursed electronically.

"Fees associated with electronic transactions for physician services are an unnecessary and costly burden on providers and patients," said Rep. Murphy in a press release. "Greedy health insurers attempt to scalp doctors and patients every step of the way throughout the care process to line their pockets. We don't tolerate paying fees to receive direct deposit of a paycheck, likewise, doctors and patients should not be forced to pay predatory fees on electronic payments on essential health services."

In 2021, the American Medical Association (AMA) and over 90 other physician groups, including the CAP, urged the Biden administration to reinstate guidance protecting doctors’ right to receive electronic funds transfer (EFT) without fees.

In July 2022, the Centers for Medicare and Medicaid Services (CMS) said that EFT fees are allowed and are not prohibited under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

An extension to the Conrad 30 waiver program was recently included in the Further Continuing Appropriations and Other Extensions Act to avert a government shutdown in November. The program is extended through February 2, 2024.

The program allows J-1 foreign medical graduates to apply for a waiver of the 2-year foreign residence requirement upon completion of the J-1 exchange visitor program. The exchange visitor program, or J-1 visa, is a non-immigrant visa that allows eligible international candidates to travel and gain experience in the United States by participating in work- and study-based programs. Each state is allowed to sponsor up to 30 physicians each year and has developed its own application rules and guidelines. The program addresses the shortage of qualified doctors in medically underserved areas across the country.

The CMS released the final 2024 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program on November 2.

On Thursday, November 30, the CAP offered a complementary live webinar where CAP experts reviewed final regulations that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Webinar presenters included the Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bocsi, DO, FCAP. Watch the recording.

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