Advocacy Update

• CAP Joins Medical Associations in Calling to Halt Scheduled Medicare Cuts
• CLIA Proposed Regulation for 2023 Includes Changes to Laboratory Director Requirements
• Rhode Island Pathologists, CAP Amended Genetic Counselor Licensure Law Enacted
• Latest Updates on LDT Oversight
• Next Week- Proposed 2023 Medicare Payment Regulations Webinar
• New Month, New Advocacy News Quiz
• Breaking Advocacy News: Check out the Advocacy Twitter Channel

The CAP and dozens of other medical associations are calling on Congress to take immediate action to mitigate Medicare payment cuts scheduled to go into effect on January 1, 2023. The recently released 2023 Medicare Physician Fee Schedule would cut the Medicare conversion factor by approximately 4.5%. The CAP advocates to protect the value of pathology services and fights against Medicare cuts for pathologists.

The groups supported previous legislation that provided a 3% positive adjustment to the Medicare fee schedule conversion factor to partially offset a scheduled reduction. These critical payment reduction relief policies provided increased financial stability for Medicare clinicians and helped to ensure seniors-maintained access to high-quality care, especially as the COVID-19 pandemic continued to present numerous challenges, the groups wrote in a July 27 letter to the chairs and ranking members on the Senate Finance Committee and the House Energy and Commerce Committee.

“These cuts, combined with the pending threat of the 4% PAYGO reduction, are simply not sustainable,” write the groups. “The termination of the 2% sequestration moratorium in July 2022 is yet another compounding negative financial factor Medicare providers must navigate.”

The year-over-year cuts clearly demonstrate that the Medicare physician payment system is broken, the groups said. Systemic issues, such as the negative impact of the fee schedule’s budget neutrality requirements and the lack of an inflationary update will continue to generate significant instability to health care professionals moving forward, adding that they are committed to working with Congress to identify and advance the necessary reforms.

On July 22, the Centers for Medicare & Medicaid Services (CMS) released the proposed 2023 CLIA Fees; Histocompatibility alternative Waived Testing Sanctions regulation, signaling a change in the CLIA fee schedule. These proposed CLIA fee schedule changes include histocompatibility requirements, personnel requirements, and allowing for alternative sanctions for waived testing. The CAP will advocate against changes in the proposed regulation and changes to laboratory director requirements.

The proposed 2023 CLIA regulation does ask for changes to laboratory director qualifications, particularly around doctorate level scientists, such as consideration of the doctor of clinical laboratory scientist (DCLS). For instance, the proposed regulation includes defining the doctorate-level degree by providing an educational requirement of three years and asking the community to determine the degree as a DCLS or PhD. Additionally, the proposed regulation will allow non-scientific degree individuals to qualify for roles within CLIA if they meet a qualification algorithm. This would apply to technical supervision, testing personnel, and laboratory director roles.

Other key changes proposed by the CMS include:

• Creating a new fee structure that would consider travel and inspection costs.
• Establishing a new category for nurses as testing personnel and respiratory therapists as testing staff to oversee blood gas labs.
• Updating the histocompatibility requirements to reflect current-day practices primarily related to crossmatching.
• Allowing alternative sanctions for waived laboratories (including civil monetary penalties, a directed plan of correction, and onsite monitoring).

The proposed regulation combines proposals from a 2019 CLIAC report and the Centers for Disease Control and Prevention request for information released in 2018. Many changes aligned with the CAP’s advocacy efforts in histocompatibility, separate testing categories for nursing, and alternative sanctions for waived testing.

The CAP will respond to the proposed rule within the 60-day deadline.

The Rhode Island Society of Pathologists (RISP) and the CAP’s previously amended genetic counselor scope of practice legislation (House Bill 6643) was enacted by Governor Dan McKee. In 2021, the RISP and the CAP successfully removed genetic counselors’ authority to interpret complex genetic test results.

The amendments were by a longstanding agreement between the CAP and the National Society of Genetic Counselors (NSGC). The CAP affirms the interpretation of genetic test results constitutes the practice of medicine that only physicians are qualified to do.

The law went into effect upon enactment.

The Senate returned to Congress to consider a number of bills, but a vote on legislation to reauthorize existing Food & Drug Administration (FDA) user fees and the VALID Act is uncertain. The FDA needs funding from user fees, which must be reauthorized by Congress, to support its programs. FDA Commissioner Robert Califf, MD, has said recently that the FDA has enough funds to last until November – which would buy Congress additional time to find a compromise.

On July 20, the CAP, American Society of Clinical Oncology (ASCO), American Cancer Society Cancer Action Network, and several patient, laboratory industry, and other advocacy groups urged Congress to enact the VALID Act as part of the FDA user fee bill.

Additional resources and information are available from the CAP:

• Watch the recording of the CAP’s Update on LDTs and the VALID Act
• Read a message from the CAP President on the VALID Act
• Read frequently Asked Questions on the Oversight of LDTs

On Monday, August 8 at 1 PM ET/ 12 PM CT, the CAP will offer this complimentary live webinar where CAP experts will review proposed regulatory changes that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Join us for a deep dive into the proposed 2023 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS).

Webinar presenters will be the Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Economic Affairs Committee Chair Stephen Black-Schaffer, MD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Diana Cardona, MD, FCAP.

Register now

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