Advocacy Update

• CAP Argues LCD Limits Physician Decision-Making and Imposes Dangerous Scope of Practice Restrictions
• CAP Makes Recommendations to Congress on Next Steps for 21st Century Cures
• In Case you Missed it: Proposed 2025 Medicare Physician Fee Schedule Webinar Recording
• How will FDA’s LDT Rule Impact Your Laboratory and Patients? Share Your Story!
• Take Our News Quiz for August

The CAP recently met with Medicare Administrative Contractor (MAC) Palmetto GBA, a company that handles Medicare claims for the Centers for Medicare & Medicaid Services (CMS), and expressed deep concerns that the MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma Local Coverage Determination (LCD) improperly limits the scope and defines the practice of medicine by board-certified pathologists, licensed physicians and surgeons, who are eligible to order laboratory tests.

In a March 1 letter to CMS and Palmetto, the CAP requested that the subspecialty requirement in the LCD – that any molecular test approved for coverage under the LCD be ordered by a board-certified or board-eligible dermatopathologist – be removed from the coverage policy. The CAP stated further that

imposing restrictions, as a condition of coverage, as to the subspecialty qualifications of those who can order certain tests exceeds the scope of authority of a MAC and contravenes state and federal laws that govern physician scope of practice and prohibits interference in the practice of medicine.

In a July follow-up letter to CMS, the CAP again requested that the subspecialty requirement in the LCD be removed from the coverage policy and that CMS work with its MACs to ensure local coverage policies do not violate federal regulations by limiting the scope of practice of board-certified pathologists or any other licensed physicians and surgeons who are eligible under state licensure laws to order laboratory and molecular tests required for the care and treatment of their patients.

The CAP will keep members informed of any updates to the LCD in the future.

The CAP has urged Congress to improve the coverage of pathology services and continue pandemic preparedness efforts as it drafts new measures under its 21st Century Cures initiative. As a result of the advancement of medical research and health care delivery stemming from the initial 21st Century Cures Act, Congress is considering a new set of reforms that aim to build on the success of 21st Century Cures and Cures 2.0 by focusing on ways to modernize coverage and access to life-saving cures.

In June, Reps. Diana DeGette (R-CO) and Larry Bucshon, MD (R-IN) circulated a request for information from stakeholders, including the CAP, to help guide legislators in refining strategies and ensuring a legislative path under the 21st Century Cures initiative that will be beneficial to patients and the health care system.

In an August 2 comment letter, the CAP urged legislators to consider the following:

Local Coverage Determination (LCD) Improvements

• Thoughtful discussion and timely feedback from stakeholders and advocates who have unique insight into the nature of local practice and the needs of local patient populations.
• Transparency, consistency, and clarity around how stakeholders are expected to participate in the LCD process.
• Transparency regarding the status of reconsideration requests and a timeframe for Medicare Administrative Contractors (MACs) to complete a reconsideration request for a revision to an LCD.
• Making public the performance of each MAC with respect to performance requirements and measurement standards.

Meaningful Access to Federal Health Plan Claims Data

• Ensuring clinician-led clinical data registries have meaningful access to claims data will enable such entities to better track patient outcomes over time, expand their ability to assess the safety and effectiveness of medical treatments, and provide them with the information necessary to assess the cost-effectiveness of therapies.

Ensuring Medicare Coding Consistency

• Continue to utilize a HIPAA-compliant code set, which requires all providers, clearinghouses, and payors to use the American Medical Association Current Procedural Terminology (CPT) code set.

Continuing Pandemic Preparedness Efforts

• Consider policies to standardize electronic laboratory reporting and authorize funding to enhance laboratory information systems at the federal and state levels to ensure critical data on disease spread can be shared with public health agencies.
• Support the creation of national standardized minimum data reporting requirements and formats in which clinical laboratories would be required to report only to the state in which the laboratory is located.
• Ensure there is a mechanism to provide adequate coverage and reimbursement of tests during a public health emergency so that the public can access tests as needed and laboratories have enough revenue to continue operating.

The CAP urged Congress to work with them to continue improving treatment options and increasing important research for patients.

Did you miss the proposed 2025 Medicare Physician Fee Schedule webinar on July 30? Listen to the recording of our expert panel 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 present and answer questions about the latest Medicare payment policies concerning individual pathology services and the Quality Payment Program next year. Download the presentation slides.

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy on your community? Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for laboratories.

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