Advocacy Update

• UnitedHealthcare Hears the CAP’s Concerns and Delays Deadline for Z-Code Compliance for Reimbursement
• CMS Implements Insurance Enrollment and Health Coverage Rule Supported by CAP
• AMA Survey on Impact of Change Healthcare Cyberattack Due April 3
• Foreign Medical Graduates Waiver Program Extended to September 30
• CISA Proposed Rule Marks Step in Bolstering Cybersecurity
• TSP and CAP Amend Tennessee Bill to Resolve Concerns Over Laboratory Operations
• FDA Revokes Emergency Use Authorizations for Six COVID-19 Tests
• Take Our News Quiz for April

UnitedHealthcare is delaying the implementation of new requirements to use Z-codes for reimbursement. After an initial delay, UnitedHealthcare announced the start date as April 1, 2024. The new date of implementation, announced this week, is June 1, 2024. The CAP and affected laboratories had expressed concerns over the ability to submit claims under this new system. As a result, UnitedHealthcare is both working with many laboratories individually and providing additional time. UnitedHealthcare says it will continue to work with impacted laboratories.

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 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. Non-standard coding practices have serious negative consequences for pathologists and laboratories trying to implement conflicting requirements.

To receive additional support, reach out to provider advocates and United_Genetics@uhc.com.

On March 27, the Centers for Medicare and Medicaid Services (CMS) unveiled the Streamlining the Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes final rule that will remove barriers to enrollment and build on the Affordable Care Act’s (ACA’s) coverage protections. The final regulation adopted several accesses to health insurance provisions supported by the CAP.

The CAP had responded to the proposed version of the regulation to improve Medicaid and CHIP on November 7, 2022. In a letter to the CMS, the CAP supported ways to improve and expand Medicaid to ensure increased health care coverage, especially for low-income people, and address health care inequalities and disparities in the US health system.

The CAP also said that "without accessible health insurance, patients are more likely to delay seeking needed medical care, including diagnostic testing, and screening services. Access to preventative care, cancer, and other screening services, as well as treatment for chronic illnesses and mental health disorders, are essential for communities of color and other underserved populations.”

The CAP also supported increasing health coverage in both the Health Equity and Accountability Act and by providing comments in the 2021 budget reconciliation package. In addition, the CAP supported providing premium tax credits to help pay for plans on Affordable Care Act marketplace.

The American Medical Association (AMA) is asking physician practices to fill out an anonymous, informal survey on the impact of the Change Healthcare cyberattack. This 11-question survey is due by noon CT on Wednesday, April 3. Practices may use estimates in their responses and the AMA will use the information to inform advocacy efforts on this issue that will inform discussions with federal officials and payers. For the latest information visit: Change Healthcare cyberattack response.

An extension to the Conrad 30 waiver program was included in the recently enacted Further Consolidated Appropriations Act of 2024. As a result, the program is extended through September 30, 2024. The CAP will lobby for a longer extension of the program and add more waivers during the Pathologists Leadership Summit April 13-16.

The program allows J-1 foreign medical graduates to apply for a waiver of the two-year foreign residence requirement upon completion of the J-1 exchange visitor program. The exchange visitor program, or J-1 visa, is a nonimmigrant visa that allows eligible international candidates to travel and gain experience in the United States by participating in work- and study-based programs. Each state can sponsor up to 30 physicians each year and has developed its own application rules and guidelines. The program addresses the shortage of qualified doctors in medically underserved areas across the country.

The Conrad State 30 and Physician Access Reauthorization Act represents legislation aimed at reauthorizing the Conrad 30 waiver program for three years. Importantly, the bill would increase the number of waivers granted to each state from 30 to 35. It also enhances transparency in employment contract terms and provides for greater immigration flexibilities for families of participating physicians.

On March 27, the Cybersecurity and Infrastructure Security Agency (CISA), which is part of the Homeland Security Agency, released a proposed rule on cybersecurity incident reporting requirements related to the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) which was signed into law in 2022. CIRCIA requires covered entities to report to CISA covered cyber incidents within 72 hours after the covered entity reasonably believes that the covered cyber incident has occurred, and ransom payments made in response to a ransomware attack within 24 hours after the ransom payment has been made. This proposed rule implements and defines the requirements in CIRCIA.

What is a covered entity that applies to pathology?

• Hospitals
• Manufacturers of class II and III devices (which include digital pathology devices)
• Laboratories with annual revenue of over $41.5 million

What is a covered cyber incident?

• A substantial loss of confidentiality, integrity, or availability of a covered entity’s information system or network.
• A serious impact on the safety and resiliency of a covered entity’s operational systems and processes.
• A disruption of a covered entity’s ability to engage in business or industrial operations or deliver goods or services.
• Unauthorized access to a covered entity’s information system or network, or any nonpublic information contained therein, that is facilitated through or caused by either a compromise of a cloud service provider, managed service provider, other third-party data hosting provider, or a supply chain compromise.

Implementation of CIRCIA will improve CISA’s ability to use cybersecurity incident and ransomware payment information reported to the agency to identify patterns in real-time, fill critical information gaps, rapidly deploy resources to help entities that are suffering from cyber-attacks, and inform others who would be potentially affected. Read more.

In a recent Washington Post article highlighting the reasons why medical providers are so vulnerable to hackers like the recent Change Healthcare ransomware attack, Deputy national security adviser Anne Neuberger said “The White House is examining what laws it can use to impose standards on a reluctant industry, while telling executives that they are expected to comply with voluntary guidelines immediately. The Hill has not passed any legislation providing authorities to mandate minimum standards, which is why we have been using sector emergency authorities or rulemaking.” She also said some requirements will come soon for providers that accept Medicare and Medicaid.

The CAP will continue to engage with the federal government on critical issues related to cybersecurity standards and reforms.

The Tennessee Society of Pathologists (TSP), the CAP, and the Tennessee Medical Association (TMA) successfully amended Tennessee legislation (SB 2230/HB 2545) relative to medical laboratory operations in a rural hospital setting on March 19. The bill would have adversely limited pathologist medical directors in supervising laboratories, created a new state mandated credentialing for medical laboratory supervisors, and improperly impeded the accreditation of hospital clinical laboratories by the CAP.

Laboratory personnel licensure in Tennessee had been previously repealed and for laboratory supervisors, the legislation would have reversed that repeal by establishing new credentialing. Under the amendment, there is no new credentialing, and supervisors and pathologists will be able to oversee up to five separate rural hospital based clinical laboratories - consistent with the federal CLIA law. The legislation was amended by the state Senate and House health committees to address all pathologist and CAP technical concerns with the legislation.

On March 21, the Food and Drug Administration (FDA) revoked six Emergency Use Authorizations (EUAs) of in vitro diagnostic devices for detection and/or diagnosis of COVID-19 to:

• Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit
• Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit
• Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit
• bioMérieux SA, for the VIDAS SARS-CoV-2 IgM kit
• bioMérieux SA, for the VIDAS SARS-CoV-2 IgG kit
• Luminex Corp., for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay

When an EUA is revoked or terminated, there will be a date beyond which the test(s) can no longer be used. Make sure to discontinue use and discard any remaining product inventory whose EUA was revoked. These items will no longer be available and if a lab uses them, they will need to find a replacement.

For additional FDA guidance visit: Emergency Use Authorization of Medical Products and Related Authorities.

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