Advocacy Update

• CAP Advocacy Win: CMS Increases Cytotechnologist Labor Rate by 12%
• President Biden Signs Funding Bill to Stop Federal Shutdown; Delays Clinical Lab Fee Cuts for 1 Year
• CAP Continues to Advocate for Passage of SALSA as PAMA Cuts Get One Year Delay
• ICYMI: CAP Urges Members to Comment on LDT Proposed Rule before December 4 Deadline
• AMA Invites Physicians and Health Professionals to Complete Equity Strategic Planning Survey by Today, 11/21
• Webinar: What Will Be the Impact of the Final Fee Schedule on Your Practice?
• Take Our News Quiz for November
• Editor’s Note

In August, the CAP met with the Centers for Medicare and Medicaid Services (CMS) to advocate for an increase in the cytotechnologist labor rate. In the 2024 Medicare Physician Fee Schedule, the CMS agreed with the CAP’s request and finalized a two-year, phased-in increase of 12% starting in 2024. This increase was supported by public wage survey data and more accurately reflects cytotechnologist education, job duties, workforce shortages, and recruitment challenges. The following table summarizes the impacts to a sample of codes based on this change. The relative value units (RVUs) should continue to increase in 2025 as part of the phase-in.

Pathologists providing cytopathology and flow cytometry services stand to benefit from the CAP’s advocacy win in their practice expense methodology to determine physician fee schedule payment. Services paid through the Medicare physician fee schedule have two components: a physician work component and a technical component. The technical component represents the clinical (non-physician) labor, medical supplies, and equipment used to furnish a particular service. Clinical labor is represented as a per minute expense, with the CMS determining the rate paid for each clinical labor type as a component of the practice expense RVU and payment rate.

Last year, the CAP advocated for a separate increase to the histotechnologist clinical labor rate. This increase was finalized in the 2023 Medicare physician fee schedule and continues to be phased-in over the coming two years. As a result of these two policies, many pathology services may experience an increase in their technical component and global payments in both 2024 and 2025.

This advocacy win highlights the role of practice expense in determining pathology reimbursement. Physicians should be on the lookout for two recent practice expense surveys from Mathematica. The first survey will seek practice expense information from individual practices, while the second survey will collect patient care hour data from individual physicians. It is vital that pathologists complete this survey as this specialty-level data will be shared with the CMS to update the Medicare Economic Index and practice expense relative values on the physician fee schedule. To learn more about the PPI (Physician Practice Information) Survey click here.

President Biden signed a stopgap spending bill, sometimes called a continuing resolution or CR, to fund part of the government until mid-January and the remaining programs within the annual appropriations process through early February. The bill will extend funding until January 19 for priorities including military construction, veterans’ affairs, transportation, housing, and the Energy Department. The rest of the government – anything not covered by the first step – would be funded until February 2. Importantly for pathologists and their laboratories, Medicare cuts to the Medicare clinical laboratory fee schedule were also delayed by one year in the bill (see next story).

Now Congress will then have two separate deadlines to pass full-year fiscal 2024 appropriations bills. The House has passed seven of the 12 annual appropriations bills that Congress must approve each year. Regular appropriations bills are the twelve standard bills that cover the funding for the federal government for one fiscal year.

The CR did not include funding to provide relief to physicians at a time when burnout and practice costs are increasing. Therefore, the CAP will continue to call on Congress to pass legislation to mitigate the impact of the Medicare Cuts before the end of the year.

Last week, Congress included a one-year delay to Protecting Access to Medicare Act (PAMA) cuts to clinical laboratory fees in the short-term funding bill later signed into law. The one-year delay for PAMA cuts prevented targeted payment reductions up to 15% by delaying the reporting and collecting of private insurance payments for clinical laboratory services and extending the zero-percent cap on payment reductions through 2024. This is the fifth time Congress has intervened on a bipartisan basis to delay the next CLFS reporting periods and the fourth time they have intervened to delay cuts to maintain access to laboratory services for patients.

In 2014, Congress passed PAMA, to reform the Medicare clinical laboratory fee schedule (CLFS) to a single national fee schedule based on private market data from all types of laboratories that service Medicare beneficiaries, including independent laboratories, hospital outreach laboratories, and physician office laboratories (POLs).

Unfortunately, the first round of data collection in 2017 failed to capture an adequate and representative sample of private market data, leaving out virtually all hospital outreach laboratories and significantly under-sampling POLs. The significant under-sampling led to nearly $4 billion in cuts to those laboratories providing the most commonly ordered test services for Medicare beneficiaries. For context, the total CLFS spend for 2020 was only $8 billion, less than 3% of Medicare Part B spending.

While Congress has delayed drastic cuts of up to 15%, without a sustainable solution to this problem, laboratories will face further rounds of cuts in 2025.

The Saving Access to Laboratory Services Act, or SALSA (S.1000/H.R. 2377), is a permanent solution that would set Medicare reimbursement for clinical laboratory services on a sustainable path forward. SALSA will give the Centers for Medicare and Medicaid Services (CMS) new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services where previous data collection was inadequate.

The bill ensures true private market rates are included and provides a much-needed reduction in the reporting burden. By providing a gradual phase-in approach, the bill protects clinical laboratories, the Medicare program, and patients from the impact of dramatic rate increases or decreases.

In April, the CAP joined other industry stakeholders, including the American Medical Association and the American Clinical Laboratory Association, in sending a letter of support to congressional leadership urging the passage of SALSA.

Urge Congress to pass SALSA today!

The CAP is encouraging its members to register their written comments to the US Food and Drug Administration (FDA) regarding the proposed rulemaking on laboratory-developed tests (LDTs) before the comment period ends on December 4.

The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk, and would extend FDA oversight first to higher-risk (Class III) devices then to medium-risk (Class II), then to lower-risk devices (Class I) over the course of five years. This would be done by instituting the same general requirements as with Medical Devices: premarket review (as applicable), Quality Systems (QS), and registration and listing requirements for these tests, in addition to medical device reporting (MDR) requirements (i.e., reporting of adverse events), correction and removal reporting requirements, and others. The proposed rule is looking to institute those same requirements but somewhat tailor them to the specifics of Laboratory Developed IVDs. Once fully implemented in 2028, all IVDs offered as LDTs by a laboratory would generally fall under the same enforcement approach as other IVDs.

While the CAP and other laboratory groups have lobbied for a 60-day extension of the comment period, the FDA has stated it will not extend the comment period. Therefore, CAP members should not assume that the comment period will be extended. The CAP encourages members to provide substantive comments on the specific impact of the proposed rule on patient access to testing and the costs and regulatory burden associated with complying with the rule.

Read more.

At the 2023 AMA Interim Meeting, the health equity open forum highlighted the process for developing the AMA's 2024-2025 Strategic Plan to Embed Racial Justice and Advance Health Equity. Following this session, our AMA invites delegates, alternate delegates, staff of professional societies, and additional interested parties to complete our Equity Strategic Planning survey by today, Tuesday, November 21.

• AMA Delegates / Alternate Delegates: https://survey.az1.qualtrics.com/jfe/form/SV_aXDKaQGpbYrR3v0
• Additional Interested Parties: https://survey.az1.qualtrics.com/jfe/form/SV_0iUXg3WQeipGqTs

The survey will gather your recommendations to inform elements of our AMA’s external facing 2024-2025 equity strategic plan. The survey will take at minimum 10 minutes to complete. All data will be anonymous. If you have any questions about the survey, please contact: Dr. Bill Jordan (william.jordan@ama-assn.org).

The CAP worked on the following policy during the meeting:

Medicare Payment Reform

Medicare physician payment was a top priority for delegates—with the support of the Pathology Section Council and CAP, the House of Delegates adopted new policy to “continue to prioritize reforming the Medicare payment system to ensure the continued economic viability of medical practice”—with specific focus on stopping the 3.37% cut and achieving sustainable annual Medicare payment increases.

Advocating on Self-Referral

CAP leaders were successful in urging the House of Delegates not to adopt a policy calling on the AMA to reverse a blanket ban on physician self-referral. The Physician Self-Referral Law, also known as the Stark law, makes it illegal for a physician to refer Medicare or Medicaid patients to any entity in which that physician, or an immediate family member, has a financial stake, with certain exceptions. With extensive experience as a quality standards-setting organization, the CAP believes that reform to the Physician Self-Referral Law should be approached cautiously and only with appropriate guardrails to address improper utilization and protect patient care. It is critical that the AMA avoid making changes to the Stark law that could have unintended consequences on physician self-referrals, leading to increased improper utilization, disruptive and/or abusive behavior/practices, and unnecessary costs to the Medicare program.

Scope of Practice

The House of Delegates reaffirmed existing policy to maintain the authority and oversight of state medical boards in the regulation of non-physician health professionals, and also reaffirmed policy on Truth in Advertising. Delegates also referred for study by the AMA Council on Legislation a proposed policy directing the AMA to draft model legislation requiring “all facilities that imply the provision of emergency medical care have the real-time, on-site presence of a physician.” Finally, CAP leaders attended the AMA’s Scope of Practice Partnership meeting and learned about the latest efforts to combat scope creep. Fighting scope creep is a critical component of the AMA Recovery Plan for America’s Physicians. Patients deserve care led by physicians—the most highly educated, trained and skilled health professionals. Together with the CAP, the AMA vigorously defends the practice of medicine against scope of practice expansions that threaten patient safety.

Health System Reform

The AMA maintained its opposition to single-payer health reform after delegates discussed a proposal during reference committee at the Interim Meeting. The AMA has longtime, extensive policies that support a pluralistic system that ensures choice of coverage for patients and autonomy of practice for physicians. The AMA has advocated to shape numerous major health system reform proposals in recent decades. Learn more about the AMA vision on health system reform.

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

On Thursday, November 30 at 3 PM ET/ 2 PM CT, the CAP will offer a complementary live webinar where CAP experts will review final regulations that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Webinar presenters will be 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 Bosci, DO, FCAP.

Register today.

Are you up to speed on CAP advocacy news? Take our new monthly news quiz and see how many you can get right and share your results on social media.

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Due to the Thanksgiving holiday, the next edition of Advocacy Update will be December 5. If important news breaks, the CAP will send a special edition of the newsletter or post information on our Twitter account @CAPDCAdvocacy.