Advocacy Update

• ICYMI: CAP Remains Concerned with FDA Moving Forward with LDT Final Rule
• CAP Recommends Ways Senators Can Stabilize Physician Payment System, Grow Workforce
• The 2024 Practice Characteristics Survey Is Open until May 10. We Need Your Participation!
• Tennessee Legislature Passes CAP Recommendation on Reporting Test Results
• FTC Bans Noncompete Agreements in Employer-Employee Contracts
• Special Guest Attends Back the PAC reception
• Nominate a House of Delegates Leader for Pathology Achievement Award
• Take Our News Quiz for April

The Food and Drug Administration (FDA) released the final regulation on the oversight of laboratory-developed tests (LDTs) with some changes advocated for by the CAP. The CAP had opposed the regulation as written and called for several improvements that would ensure patient access to testing and allow for the continued innovation of new tests.

The CAP sent out a special edition of Advocacy Update on April 29 examining the rule and we will provide additional updates on the regulation as new information becomes available. CAP President Donald Karcher, MD, FCAP also issued a statement after the final rule’s release.

In the CAP’s initial analysis, we recognized that the FDA adopted the CAP’s recommendation to allow LDTs offered prior to the rulemaking’s issuance to remain under the FDA’s enforcement discretion policy. The CAP will work to clarify with the FDA exactly when and which LDTs will continue under enforcement discretion through this provision.

The FDA also acted on the CAP’s recommendations regarding LDTs for unmet needs. The final rulemaking states the FDA will continue to apply enforcement discretion for LDTs developed and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system when an equivalent FDA-authorized test is not available. Previously, the CAP advocated to allow for continued enforcement discretion for clinical laboratories developing and running LDTs meeting the following criteria: offering LDTs in small volumes; serving their local communities with active involvement in patient care; using well-characterized standard tests; and the intended use is for diagnosing rare diseases or meeting other local population needs.

The CAP is continuing to analyze this section of the rulemaking to determine the impact on laboratories.

The FDA is hosting an implementation webinar on Tuesday, May 14.

During the webinar, the FDA will:

• Provide an overview of the final rule amending the FDA's regulations

• Describe the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs).

If you have questions about this final rule that you wish to submit for possible discussion during the webinar, email CDRHWebinars@fda.hhs.gov. All questions must be received by May 7, 2024, to be considered for the discussion.

You can register here.

The CAP will continue to be engaged on this important issue and work closely with the FDA, Congress, and other stakeholders to ensure that oversight of LDTs will not prevent patient access to safe and effective LDTs and will not unduly impact our members or their laboratories.

For questions about the FDA regulation or CAP Advocacy, please contact our DC Office at advocacyupdate@cap.org.

On April 11, the Senate Finance Committee held a hearing, “Bolstering Chronic Care through Medicare Physician Payment” to discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors. The CAP submitted a statement for the record outlining a number of policy recommendations to help stabilize the physician payment system, grow the health care workforce, increase oversight of insurer-imposed policies that impact patient care, and look at meaningful sources of health spending to fund reform.

The recommendations include:

• Pass legislation to provide an inflationary update to the Medicare Physician Fee Schedule.
• Pass legislation to eliminate, revise, or replace the budget neutrality requirements in Medicare.
• Pass legislation to maintain meaningful quality measures to enhance health outcomes and improve the quality of care for patients, their families, and various health care entities.
• Pass legislation to improve stakeholder participation in the development of new payment models.
• Pass legislation requiring physician-focused payment model committee (PTAC) submitters to consult participating and affected specialties prior to model submission so that the PTAC can make recommendations on models that are truly physician-focused and enable meaningful contribution of their participants in enhancing the care of patients.
• Pass legislation requiring that traditional MIPS options be maintained for single specialty practices to ensure that private/independent practices of all sizes remain a viable option for physicians.
• Pass The Resident Physician Shortage Reduction Act
• Pass The Conrad State 30 and Physician Access Reauthorization Act

The CAP and its members lobbied for several of these provisions during the 2024 Pathologists Leadership Summit and Hill Day.

The CAP encouraged the committee to look at waste and consolidation in the health care system as a potential source of revenue to stabilize the payment system and grow the workforce in lieu of site neutral policies.

The 2024 Practice Characteristics Survey is open, and all pathologists are asked to share critical, first-hand data from their practices to assist in shaping CAP’s advocacy priorities as it captures and quantifies changes in the practice of pathology. Pathologists are facing far too many challenges that interfere with practicing and patient care. We all agree the issues are many, including (but certainly not limited to):

• Declining Medicare reimbursement
• Increasing prior authorizations
• Fulfilling staffing shortages
• Changing practice models
• Concerns over practice scope infringements
• So many more

This is why the CAP critically needs your input to build the next advocacy agenda. The information garnered from this nationwide survey will identify the changes in pathology practice and economics to better inform CAP advocacy priorities.

How do I participate?

On April 29, all board-certified pathologists practicing in the United States (with the exception of those still in training and pathologists who are Emeritus members of the CAP) should have received an email from CAP President Donald Karcher with a unique link to the survey. Please use this secure link to complete the 10-15minute survey no later than Friday, May 10. If you are unable to locate your email invitation, please email PracticeSurvey@cap.org with your full name and we will send your unique link to the survey.

What can I expect as follow-up?

Although all responses are confidential and will never be associated with any individual or any specific practice, we will share the anonymized aggregate results with participants to help inform and guide future decisions regarding your practice. In addition, because your input is a valued component to building a robust advocacy agenda, upon completion we invite you to select a $10 gift card from Amazon, Starbucks, or Visa as a small token of our gratitude.

On April 22, the Tennessee legislature passed legislation (SB 2012/ HB 2011) displacing the information-blocking requirements of the federal 21st Century Cures Act for certain test results and pathology reports. The Tennessee Society of Pathology (TSP), the CAP, and the Tennessee Medical Association (TMA) successfully amended the legislation to address pathologist concerns with the initial bill. The TSP and CAP worked to safeguard pathologists and laboratories from federal legal risks under the Cures Act considered to be information blocking, resulting from delays in the release of diagnostic testing results to patients.

The new law places exclusive responsibility on “designated entities,” for any delay in certain pathology reports and test results to be withheld for 72-hours before patients can access the result in the electronic health record. Under Tennessee law, “Designated entities” is defined as “an entity that performs actions or functions on behalf of the provider, payer or patient for the purposes of creating an electronic health record.”

The TSP, CAP, and the TMA amendment removed legal and operational non-compliance risk to pathologists and clinical laboratories by placing the state legal obligation of withholding certain clinical laboratory and pathology test results and reports exclusively on the entities or persons who control the electronic health record – and not the pathologist or clinical laboratory. The bill is now pending consideration by Tennessee Governor Bill Lee (R). If enacted, Tennessee would be the second state, following Kentucky, that has adopted the CAP position in the context of these laws.

On April 23, the Federal Trade Commission (FTC) issued a final rule to ban noncompete agreements that prevent employees from working for competitors or starting a competing business after they leave a job. The FTC determined that it was an unfair method of competition, and therefore a violation of Section 5 of the FTC Act, for employers to enter into noncompetes with workers and to enforce certain noncompetes. The rule, set to go into effect in 120 days, would ban new noncompete agreements for all workers and require companies to let current and past employees know they will not enforce them.

Once the rule goes into effect, companies will also have to throw out existing noncompete agreements for most employees, however the agreements may remain in effect for senior executives.

The American Medical Association estimates that between 35% and 45% of physicians are bound by noncompete clauses. The AMA’s House of Delegates voted to oppose non-competes for doctors at for-profit and nonprofit hospitals, hospital systems or who are employed by staffing firms. The AMA has noted that some doctors who are employers and own physician practices may support "reasonable non-competes," while employed physicians might support banning the agreements.

Although the FTC does not have jurisdiction over nonprofit entities, the rule could have significant implications for the healthcare industry. The FTC says it reserves the right to evaluate an entity's nonprofit status, which could include a significant portion of hospitals in the U.S.

Shortly after the rule was released, the US Chamber of Commerce filed a lawsuit in the U.S District Court for the Eastern District of Texas alleging that the FTC lacks the authority to issue the rule and that it is unlawful because noncompete agreements are “not categorically unlawful under Section 5.”

Once the rule is effective, participants can report information about a suspected violation of the rule to the Bureau of Competition by emailing noncompete@ftc.gov. Read more.

On Monday, April 15, PathPAC was thrilled to welcome special guest, Rep. Kim Schrier, MD (D-WA) to the Back the PAC reception for the winning teams of the House of Delegates (HOD) competition and raffle winners. Rep. Schrier commended the group for their advocacy on behalf of physicians and patients and encouraged their continued engagement with the political process in this important election year. Rep. Schrier is a member of the House Energy and Commerce Committee, which has jurisdiction on some key health care policy issues.

Nominations are open for the Dr. Mary Fowkes HOD Pathology Achievement Award.

This award continues the legacy of the late Mary Fowkes, MD, FCAP, and honors a pathologist who demonstrates commitment, achievements, bridging state, federal resources to advance pathologists; or effectively works for the specialty across organized medicine. This annual award will be presented to a current or former CAP House of Delegates member.

Any current or former HOD can submit nominations.

The 2024 nomination period is open through May 31, 2024.

Nominate your colleague 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.

Take the quiz.