Advocacy Update

• CMS Allows Pathologists and Lab Personnel Ability to Review Digital Slides Remotely
• FDA Finalizes Recommendations Allowing Gay and Bisexual Men to Donate Blood
• Landmark Network Adequacy Bill Amended by TSP, CAP Becomes Law in Tennessee
• Georgia Pathologists, CAP Help Enact Multiple Laws and Deter Adverse Legislation
• News Quiz: How Many Can You Get Right?

As the COVID-19 public health emergency ended May 11, the Centers for Medicare & Medicaid Services (CMS) updated its guidance to allow pathologists the ability to review digital slides and data remotely as long as they meet specific criteria. In addition, CMS changed its policy to allow clinical laboratory personnel (non-pathologists) to also review digital images and data remotely. This flexibility was granted during the early days of the pandemic and the CAP had advocated for it to continue once the public health emergency ended.

Read the latest version of the CMS’s guidance

The CMS terminated many of the enforcement discretion flexibilities that were implemented during the emergency, such as issuance of expedited CLIA certificates, use of expired reagents, and use of molecular and point of care tests on asymptomatic patients. Federally mandated reporting of COVID-19 test results is also ending but some states may still require laboratories to provide state health departments with data.

What is Required for Remote Sign-Out

With regards to remote sign-out of cases, physical slides read under a microscope cannot be read remotely under a primary location CLIA certificate. This would be considered a secondary site and would need a separate CLIA certificate. To review digital slides and data remotely, pathologists and personnel must meet the following criteria:

• The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation.
• The primary laboratory complies with other applicable federal laws, including HIPAA.
• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
• Survey findings will be cited under the primary laboratory’s CLIA certificate. Enforcement actions, if taken, will affect the primary laboratory’s CLIA certificate.
• The primary laboratory’s test reports must indicate the remote site location where the testing is performed. The laboratory may use a coding system rather than the remote site address, eg, personnel residence, on the final report. This coding system must be available upon request.
• The primary laboratory must be certified in the specialties and/or subspecialties of the work performed at the remote site.
• The primary laboratory must provide the CMS with a list of all staff working remotely, upon request.
• The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.

Testing on Asymptomatic Patients

Enforcement discretion for using molecular and antigen SARS-CoV-2 tests for asymptomatic individuals ends; however, clinical laboratories can continue using these tests if they are following the manufacturer’s instructions for use, including for SARS-CoV-2 testing. If a test’s intended use is modified from what is required by the manufacturer’s instructions, the test becomes high complexity and clinical laboratory must meet all high-complexity requirements. The CMS will not consider the tests modified when testing is done for individuals suspected of COVID-19 by their health care provider.

The Food and Drug Administration (FDA) published its final recommendations for assessing blood donor eligibility with a set of individual risk-based questions that reduce risk of transfusion-transmitted HIV and would also allow for monogamous gay and bisexual men to donate blood. The recommendations also reflect the CAP’s advocacy and comments to expand the number of people eligible to donate blood while also protecting the safety of the blood supply.

In its comments to the FDA, the CAP supported the use of individual risk-based questions instead of gender-based criteria to evaluate donors for risk of HIV and encouraged the FDA to continue monitoring blood donor and donation safety, as well as performing ongoing evaluations of donor regulations to be as inclusive as possible while maintaining transfusion safety. The FDA new policy eliminated time-based deferrals and screening questions specific to men who have sex with men and women who have sex with men who have sex with men.

Under the final guidance, all prospective blood donors would answer a series of individual, risk-based questions to determine eligibility, the FDA said. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.

Read the final guidance

On May 5, Tennessee Gov. Bill Lee enacted a landmark network adequacy law after several years of persistent advocacy by the Tennessee Society of Pathologists (TSP) and the CAP in collaboration with the Tennessee Medical Association (TMA). The TSP, CAP, and TMA successfully advocated for several provisions to strengthen network adequacy review of health insurance plans by the state insurance commissioner.

As advocated by TSP and CAP, the law mandates managed health insurance plans to include a report for each in-network hospital with the percentage of specialty physician providers in-network such as pathologists, emergency medicine, radiologists, and anesthesiology subject to state insurance commissioner oversight.

This protection will help ensure health plans cannot deceptively or falsely advertise commercial insurance plans that claim adequate networks of in-network physicians while plans have failed to contract sufficiently with specialty physicians at in-network hospitals and facilities.

Of note, the TSP and CAP successfully advocated for insurance commissioner oversight over managed health insurance plans to report ‘material changes” to their approved network plans at least 15 days before such changes take effect. This fundamental protection will ensure enrollees do not have unexpected, disrupted access to care and physicians can provide timely care to Tennessee patients.

Additionally, the new law mandates health insurance plans to contract with a “sufficient number of contracted providers practicing at the same in-network facilities with which the managed health insurance issuer has contracted to reasonably ensure enrollees have complete and comprehensive in-network access for covered services delivered at those in-network facilities.”

The CAP advocates for states to require health plans to have adequate networks of hospital-based physicians, including pathologists. Tennessee joins a handful of states that have enacted state insurance network adequacy oversight of specialty physicians.

Lastly, the legislation directs the state commissioner of insurance to conduct a study on the federal No Surprises Act implementation and subsequent implications to Tennessee physicians and health care facilities by November 1, 2023.

The CAP will continue to partner with TSP in the months ahead.

The Georgia Association of Pathologists (GAP) and the CAP together scored several legislative victories that protect patients and pathologists in the state. To strengthen the profession of pathology nationwide, the CAP partners with state pathology societies to bolster advocacy efforts.

Improving Health Insurance Plan Network Adequacy

The GAP- and CAP-backed legislation, Senate Bill 20, was enacted by Gov. Brian Kemp to expressly require state oversight over health plan network adequacy, including clinical laboratory services, to ensure covered persons can access in-network “the full scope of benefits and services covered under the plan.” In addition, the state insurance commissioner must assess “the availability of participating providers that are within a reasonable time and distance to covered persons.”

The GAP and CAP worked in partnership with the Medical Association of Georgia (MAG) to advance the legislation to provide proper insurance department oversight mechanisms for adequate health care contracting of pathology and clinical laboratory services for Georgia patients.

Strengthening Biomarker Testing Access

On May 2, Gov. Kemp enacted the GAP- and CAP-backed legislation, House Bill 85, to mandate Medicaid and private insurance coverage of biomarker testing when supported by robust medical and scientific evidence.

The GAP and the CAP partnered with the American Cancer Society Action Network (ACS-CAN) and the biomarker coalition of medical and public health stakeholders to advance biomarker testing coverage for Georgia patients. Private and Medicaid plans will be mandated to provide biomarker testing beginning on or after July 1, 2023, to Georgia patients.

Deterring Out-of-Network Written Estimates

Furthermore, the GAP and the CAP successfully deterred the advancement of House Bill 70 in the 2023 legislative session. With such efforts, legal constraints were successfully thwarted by removing written estimates for health care services exceeding $100 and protecting patient access to non-emergency and emergency services.

With MAG’s support, the GAP and CAP provided opposition comments to the sponsor and received receptive acknowledgment of these concerns. As a result, the legislation failed to advance and will be carried over to the 2024 legislative session. The CAP will continue to oppose any bill advancement.

1st CAP-Amended Physician Title Protection Legislation Enacted

Lastly, Gov. Kemp enacted the first CAP and state pathology society-amended physician title protection legislation, Senate Bill 197, to protect against nonphysician use of physician nomenclature.

The GAP and CAP closely worked with the American Society of Anesthesiologists (ASA) on the legislation to include an explicit exemption for health care practitioners such as speech-language pathologists to ensure their current title use under title protection laws, to avoid any conflicts with physician nomenclature. This inclusion will remove regulatory barriers in the future and enhance the new statutory protections for pathologists from inappropriate non-physician title use and deceptive advertising. The law will take effect on July 1, 2023.

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