Advocacy Update

• CAP President Meets with Congress and Seeks Relief from Burdens of FDA LDT Rule
• UnitedHealthcare Implements Z-code Requirement June 1
• CAP Urges CMS to Increase Pathology Residency Slots, Increase Costs for Gene Therapies and Adjustment Payment on CAR T-Cell Cases
• HHS Deems Change Healthcare Responsible for Breach Notifications
• CAP Advocates for the Reduction of Physician Financial and Regulatory Burdens to House Committee
• MIPS Performance Measures Now Publicly Available
• CDC Issues Guidance for H5N1 Sample Submission
• Take Our News Quiz for June 

On June 4, CAP President Donald Karcher, MD, FCAP met with multiple members of the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions. Following the release of the overly burdensome laboratory-developed tests (LDT) regulation by the US Food and Drug Administration (FDA), the CAP has sought to engage with congressional leaders to advocate for legislative solutions that reduce regulatory burdens on laboratories and allow for continued innovation of tests.

Dr. Karcher discussed the CAP’s position on the Verifying Accurate Leading-edge IVCT Development (VALID) Act with the legislative staff of top leaders of committees with jurisdiction over the FDA. He advocated that the legislation moves in a positive direction, away from the overreach of the FDA’s LDT final rule, establishing a reasonable regulatory framework that ensures the quality of LDTs for patients and the public regarding while not stifling innovation.

He encouraged members of Congress to consider the negative implications the FDA’s strict regulation will have on pathologists and laboratories meeting the needs of a diverse patient population across the United States and how a congressional solution is the necessary path forward.

After multiple delays, UnitedHealthcare began the implementation of the Z-code requirement on June 1. UnitedHealthcare originally announced the Z-code requirement was going to be implemented in August 2023. However, the CAP met with UnitedHealthcare and was successful in getting them to delay this requirement until the previously announced date of April 1. The CAP and affected laboratories had expressed concerns over the ability to submit claims under this new system.

The CAP opposes this requirement for specific Z-code identifiers on claims to receive payment, as it would be confusing and result in complex workflow processes that will be difficult for CAP members, especially those unfamiliar with Palmetto - one of the nation's largest providers of high volume claims and transaction processing, contact center operations and technical services to the federal government and other commercial customers. In a May 31 letter, the CAP urged UnitedHealthcare to reconsider the new requirements that are needlessly disruptive, burdensome, and financially demanding for pathologists that impede patient access to medically necessary testing. The CAP has requested additional communication with UnitedHealthcare to arrive at a better solution that avoids administrative burdens and operational difficulties, which risks interfering with the ability for patients to receive timely and appropriate services.

Impacted laboratories that need assistance can contact UHC at united_genetics@uhc.com.

The CAP has sought additional Medicare funding to train pathologists and increase pay for pathology services delivered in the hospital inpatient setting in 2025. In the proposed 2025 Hospital Inpatient Prospective Payment System regulation, the CAP has asked the Centers for Medicare & Medicaid Services (CMS) to increase residency slots for pathology, increase costs associated for gene therapies for sickle cell disease (SCD) and provide payment adjustments for certain clinical trial use for immunotherapy cases.

Proposed Payments for Indirect and Direct Graduate Medical Education Costs

In the June 10 letter to the CMS, the CAP outlined the critical need to increase pathology slots in residency programs. The CAP stressed that physician shortages are occurring in specialty areas such as pathology, especially in rural areas. The pathology workforce is not keeping up with patient growth and population changes. The CAP urged the CMS to create opportunities and incentives for the pathologist workforce to expand as needed to meet population growth and ageing.

Proposed Increase of Costs of New Technology for Gene Therapies for Sickle Cell Disease (SCD)

The CAP supported the proposed increase of estimated costs of the new technology for gene therapies indicated and used in the treatment of sickle cell disease and urges the agency to finalize this proposal. The CAP does not support making this proposed increase contingent on applicants meeting additional criteria or engaging in behaviors that promote access to these therapies at a lower cost. The agency has already acknowledged that these gene therapies for SCD have the potential to improve the health of the impacted beneficiary, leading to long-term savings in the Medicare program; adding additional criteria would likely reduce access to these therapies.

Proposed Revision to Labor Market Area Delineations and Continuation of Low Wage Index Hospital Policy

The CAP recognizes that Medicare payments to hospitals (and various other provider types) are adjusted by a wage index intended to account for geographic differences across labor markets. The CMS updates the wage index annually based on hospital cost report data and other inputs and policies. This year, the CMS proposed two significant changes that would affect the wage index - revised labor market delineation and low wage index hospital policy. The CAP supported these proposals to update the wage index and urged the CMS to finalize these changes.

Payment Adjustment for Certain Clinical Trial and Expanded Access Use for Immunotherapy Cases

The CMS also proposed to continue to exclude clinical trial cases, which do not include the cost of the CAR T-cell product itself, from the calculation of the relative weight from MS-DRG 018. The CAP in its comments agreed with the CMS proposal to continue to exclude CAR T-cell clinical trial cases from the calculation of the relative weight of the MS-DRG 018 and urged the CMS to finalize this proposal. Additionally, the CAP urged the CMS to take issues such as the use of CAR T-cell in clinical trials into account as the agency updates the MS-DRG 018.

The CAP also provided feedback on Public Health eReporting request for information, opposing any new requirements that would increase burden for clinicians or impose undue hardship on pathologists.

The CAP, the American Medical Association (AMA) and more than 50 provider groups asked the Department of Health & Human Services (HHS) Office for Civil Rights (OCR) to enforce the Health Insurance Portability and Accountability Act (HIPAA) reporting requirements involving the Change Healthcare cyber incident announced on February 21. Specifically, the groups asked for clarification around reporting responsibilities to assure affected providers that reporting, and notification obligations will be handled by Change Healthcare.

On May 29, the HHS announced that covered entities (providers, hospitals, insurance companies) affected by the cyberattack do not have to take on the HIPAA-mandated responsibility of notifying patients that their health data have been breached and can delegate that responsibility to Change Healthcare. As a result of CAP advocacy, pathologists are not responsible for bearing the cost and administrative burden of sending out HIPAA notifications for a cyberattack which negatively affected them.

For more information visit: HHS OCR’s recently updated frequently asked questions webpage.

On May 23, the House Ways and Means Committee held a hearing to identify the financial and regulatory burdens facing independent medical providers and how continued challenges result in consolidated health care systems and barriers to patient care. The CAP submitted a statement for the record detailing the burdens that pathologists face and recommendations on how Congress can help mitigate those burdens to improve patient care and support physicians. The CAP requested the following:

• Combating Private Payer Challenges: The CAP requested the committee pass policies to reign in private payers, including insurer consolidation and increasing prior authorization and utilization management policies.
• Ensuring Sustainable Provider Financing: The CAP requested that the committee pass legislation to provide an inflationary update to the Medicare Physician Fee Schedule.
• Improving the Effectiveness of MACRA: The CAP requested that the committee reduce regulatory burdens in MACRA by reducing the complexity of the Medicare Merit-based Incentive Payment System (MIPS) compliance and scoring and preserving MIPS track and traditional reporting options.

Finally, with a national burnout rate of more than 50% among physicians at a time when the health care system is facing a critical shortage of physicians, the CAP asked the committee to invest in physicians today and the workforce of tomorrow.

Each year, the CMS publicly reports Quality Payment Program (QPP) performance information on the Medicare.gov compare tool and in the Provider Data Catalog. This performance information helps people with Medicare make informed health care decisions and incentivizes clinicians and groups to maximize their performance.

The CAP has been informed that three Qualified Clinical Data Registry (QCDR) measures will be included in the publicly available information. Clinicians and groups who reported CAP 22, 28, and/or 30 in 2022 will see a plain-language description of the measure(s) and their performance information on the Medicare.gov compare tool and in the provider data catalog.

This item is informational-only for clinicians. The data in Medicare.gov and the provider data catalog cannot be changed.

The Center for Disease Control and Prevention (CDC) has ramped up efforts to increase surveillance for H5N1, a Highly Pathogenic Avian Influenza (HPAI). The agency has issued guidance for submission of samples to local public health laboratories, instructing commercial laboratories to increase their submissions of influenza samples to their public health laboratories despite the usual lower case counts during the spring and summer months.

Additionally, the U.S. Department of Agriculture (USDA) has temporarily loosened restrictions on transport and possession of certain agents and toxins that are key to conducting research into H5N1. These measures are being undertaken to better understand the spread of the disease and how to combat it. The CDC continues to recommend laboratories adopt a state of “heightened readiness” regarding the spread of H5N1.

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