Advocacy Update

• CAP Supports FDA Proposal Allowing Gay and Bisexual Men to Donate Blood
• CMS to Again Offer COVID Exemptions from -9% MIPS Penalty; Physicians Must Apply
• Did You Know? Some Pathologist Quality Measure Data is Now Publicly Available
• Arkansas Pathologists, CAP-Backed Biomarker Bill Awaits Governor
• Georgia Pathologists Help Advance Biomarker and Network Adequacy Bills to Governor
• Time is Running Out—But We Have You Covered
• Feeling Lucky? Then Test Your Advocacy Knowledge

The CAP submitted comments in support of a recent proposal by the Food and Drug Administration (FDA) to relax rules on who is eligible to donate blood. Under draft recommendations announced January 26, monogamous gay and bisexual men would be allowed to donate blood and eligibility would be determined using individual risk-based questions.

The FDA proposal would eliminate time-based deferrals for men who have sex with men and women who have sex with men who have sex with men. The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months. Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months. All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.

In comments submitted March 27 to FDA Commissioner Robert Califf, MD, the CAP said it supports the proposed changes. “The proposed recommendations are more inclusive and more objective blood donor screening criteria, which expand opportunities for many prospective donors who have been excluded and potentially increases the blood supply while maintaining the high level of safety for life-saving blood transfusions that the medical community and the public expects,” the organization wrote.

The CAP encouraged the FDA to continue monitoring blood donor and donation safety, as it is necessary for all changes in donor suitability criteria via the Transfusion Transmissible Infections Monitoring Systems, and to perform ongoing evaluation of donor regulations for opportunities to be as inclusive as possible while maintaining transfusion safety. The CAP also urged the development of public information and education to promote blood donations from everyone who is eligible, including partnering with the LGBQT+ community for messaging to ensure the new policy becomes widely communicated.

Physicians may again apply this spring for a COVID hardship exemption and receive relief from future Medicare payment penalties, the Centers for Medicare & Medicaid Services (CMS) announced. The continuation of the exemption from penalties under Medicare’s Merit-based Incentive Payment System (MIPS) was in response to advocacy from the American Medical Association (AMA), the CAP, and the rest of organized medicine concerning the ongoing impacts of the COVID-19 public health emergency. The CAP has consistently advocated for relief from Medicare payment penalties to pathologists throughout the pandemic.

The CMS said it would allow physicians and group practices to apply for a MIPS Extreme and Uncontrollable Circumstances hardship exception to avoid up to a -9% MIPS penalty in 2025 based on 2023 performance. The exception will not be automatic, and interested physicians and groups must actively request reweighting of one or more MIPS performance categories due to the public health emergency. If accepted by CMS, practices’ hardship exemption would apply to 2023 reporting, and 2025 payment adjustments. The CMS expects to release the hardship exception application this spring.

Pathologists who believe they will qualify for an exemption should apply early. Exemptions are not automatic and if the CMS declines to approve an exemption, a pathologist can make other plans to stop the -9% penalty in 2025.

The CMS reports Quality Payment Program (QPP) performance data for doctors and groups in two venues: Medicare Care Compare Doctors and Clinicians profile pages and the Provider Data Catalog.

The CMS recently made available 2021 performance data, including MIPS eligible groups’ final scores and scores on certain quality measures. Starting with 2021, performance data for 8 pathology quality measures is available at the individual pathologist level in the Provider Data Catalog, which is downloadable by anyone. The measures are:

• QID 249: Barrett’s Esophagus
• QID 250: Radical Prostatectomy Reporting
• QID 395: Lung Cancer Reporting (Biopsy/Cytology Specimens)
• QID 396: Lung Cancer Reporting (Resection Specimens)
• QID 397: Melanoma Reporting
• QID 440: Skin Cancer: Biopsy Reporting Time Pathologist to Clinician
• CAP 22: Turnaround Time (TAT) - Biopsies
• CAP 28: Helicobacter pylori Status and Turnaround Time

Additionally, performance information for groups reporting CAP 22 or CAP 28 is available on Doctors and Clinicians profile pages. This is not yet at the individual performance level, like the provider data catalog. The CMS reserves the right to add performance information about quality measures once the measures meet statistical public reporting standards.

The CMS encourages Medicare beneficiaries and other patients to use performance information on Doctors and Clinicians profile pages to assist with decisions about which doctor or practice to go to. Publicly available data, including data in the Provider Data Catalog, can also be used by researchers examining trends in health care quality.

For additional information, please visit the CMS’ Care Compare website or email QPP@cms.hhs.gov.

On March 30, House Bill 1121, mandating coverage for biomarker testing, was sent to Arkansas Gov. Sarah Huckabee Sanders for further consideration. The Arkansas Society of Pathologists (ASP), in collaboration with the CAP, advocated successfully for the bill to ensure mandated biomarker testing coverage must be supported by medical and scientific evidence.

The ASP-CAP amended bill mandates state-regulated health insurance plan coverage of biomarker testing for diagnosis, appropriate management, or ongoing monitoring of an enrollee’s disease or condition to guide treatment when supported by medical and scientific evidence. Additionally, the bill expedites prior authorization review for biomarker non-emergency requests within 72 hours and 24 hours for emergency requests.

In collaboration with ASP, the CAP worked with the American Cancer Society (ACS) and the Arkansas Medical Society (AMS) to ensure the bill reflects the ACS and CAP model policy principles in support of biomarker testing subject to medical and scientific evidence as delineated. The CAP additionally supports the expedited review or waiver of biomarker testing.

The bill will be considered by the governor in the coming weeks.

As part of a multi-specialty physician coalition led by the Medical Association of Georgia, the Georgia Association of Pathologists (GAP), in partnership with the CAP, supported state legislative passage of Senate Bill 20 requiring health plan network adequacy and adequate access to clinical laboratory services to ensure covered persons have full access to their plan’s covered benefits. The bill passed the legislature overwhelmingly 52-1 in the Senate and the House by a vote of 166-2. The bill will now go to Governor Brian Kemp (R) for consideration.

The bill expressly provides that “an insurer providing a network plan shall contract with and maintain a network of participating providers in sufficient number and appropriate type, including primary care and specialty care, pharmacies, clinical laboratories, and facilities, throughout such plan's service area to ensure covered persons have access to the full scope of benefits and services covered under such plan.”

Authority is conferred upon the Commissioner of Insurance to assess health plan compliance with the network adequacy requirement. Factors to be considered by the Commissioner include: “the availability of providers, the willingness of nonparticipating providers to enter into reasonable network contract agreements with an insurer, and good faith efforts by an insurer to enter into network contract agreements with such nonparticipating providers.”

If enacted Georgia would join Louisiana, Washington, Virginia, and New Hampshire with health plan network adequacy laws that explicitly includes clinical laboratory and pathology services, provisions secured by the CAP.

Also, this session, the Georgia Association of Pathologists (GAP), in collaboration with the CAP, communicated its support for Georgia House Bill 85, legislation to mandate Medicaid and private insurance coverage of biomarker testing. The legislation, led by the American Cancer Society, and supported by numerous physician groups also secured overwhelming support at the legislature. The legislation is consistent with the new CAP public policy that supports mandated coverage for biomarker testing and the waiver of prior authorization for such testing.

That bill also now goes to Georgia Governor Brian Kemp for consideration. If enacted, Georgia would join Arizona, Louisiana, Illinois, and Rhode Island, states having a similar biomarker coverage mandate in law.

We don’t want you to miss your opportunity to connect with leaders and influencers, advance your skills, or make an impact on issues facing pathology.

Register Now to join us virtually for the 2023 Pathologists Leadership Summit, April 15-18 and benefit from education and training designed to help you grow personally and professionally. In addition, your registration includes access to session recordings on-demand after the meeting ends. Did we mention you can earn up to 11.25 CME?

Not sure if you can be present on these dates?—no worries, we have you covered. Gain access to the program’s on-demand content by registering no later than April 18 at 5:00 PM EST. Register

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