Advocacy Update

• House Bill Would Mitigate Medicare Cut; CAP Working to Stop Reductions
• FDA Plans to Finalize LDT Rule by April 2024
• CAP Opposes Horizon Managed Care Network Denial of Claims for Pathology Services
• HHS Releases Cybersecurity Strategy for Health Care Sector
• Save the Date for the Pathologist Leadership Summit in D.C. April 2024
• CDC Issues Health Alert for Mpox Cases in the Democratic Republic of the Congo
• Take Our News Quiz for December

On December 7, the House Energy & Commerce Committee passed legislation that mitigates the impact of the Medicare cuts in 2024, mirroring action taken by the Senate Finance Committee that would also raise the budget neutrality threshold and extend bonuses for alternative payment models. The CAP applauds the Energy and Commerce Committee for passing legislation to provide short-term relief while taking steps to stabilize the physician payment system.

The CAP continues to urge Congress to pass legislation to mitigate cuts to pathology services until long-term reforms are enacted. Without congressional action, physicians will face a cut of 3.37%. Throughout 2023, the CAP has urged Congress to protect patient access to pathology services:

• In April, CAP members attended 145 congressional meetings with members of the Senate and House of Representatives informing them of the value pathology and laboratory medicine brings to patient care and the impact their services have on their constituents.

• In September, CAP members sent 1,700 messages to 363 members of Congress in a campaign to urge for the reduction of 2024 Medicare cuts.

• In October, the CAP and 46 health care organizations sent a letter to Congress asking them to halt the implementation of the G2211 code which created across-the-board cuts to all physicians and other providers under the fee schedule.

• In October, over 60 pathologists participated in “virtual fly-in’s” to urge their representatives and senators to stop the cuts.

• In November, the CAP and more than 50 physician and health care groups urged House and Senate leadership to mitigate the cuts to physicians in the final 2024 Medicare Physician Fee Schedule.

• CAP members published op-ed and letters to the editor in key congressional districts urging Congress to act.

The Food and Drug Administration (FDA) plans to finalize the proposed rulemaking on laboratory-developed tests (LDTs) by April 2024, according to a work plan published by the Office of Management and Budget (OMB). So far, the FDA has received over 6,700 comments on the rule. Citing substantial undue regulatory burdens and costs on laboratories, the CAP called on the FDA to make significant changes to its proposed regulation of LDTs in a letter to the FDA on December 4.

The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify over the course of five years in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk to patients.

In its comments to the FDA, the CAP recommended that the following categories of the proposed rulemaking should continue under the FDA’s enforcement discretion policies:

• Exempting tests offered prior to the rule’s enactment
• Forensic, Human Leukocyte Antigen (HLA), and manual tests
• LDTs developed and offered locally by a clinical laboratory
• Adverse events reporting
• Quality systems
• Corrective action and removal
• Labeling

The CAP has strongly opposed a policy change by the health insurer Horizon of New Jersey to deny payment for certain pathology services.

Earlier this year, Horizon proposed revisions to its administrative policy that changed how it would “process certain claims submitted by hospital-based pathologists for services provided to members enrolled in plans/products that use the Horizon Managed Care Network.” The policy went into effect on July 1. After a review of the policy, the CAP sent a letter on November 14 to Horizon seeking clarification on the intent behind this policy update and expressing opposition to actions that add patient burdens, disrupt coordination, or compromise quality of care. The concern from the CAP is insurers’ increasing use of restrictive reimbursement requirements and/or reliance on narrow/inadequate networks, which adds unnecessary burdens to receiving laboratory testing and can interrupt continuity of care, exacerbate issues around social determinates of health, and translate to increased costs down the road.

The CAP has sought a meeting with Horizon to discuss the matter further. The CAP will keep its members updated on any new developments regarding this issue.

On December 6, the Department of Health and Human Services (HHS) released a cybersecurity plan that will take the following steps to advance cyber resiliency for hospitals, patients and communities threatened by cyber-attacks:

1. Establish voluntary cybersecurity performance goals for the healthcare sector.
2. The HHS, with input from industry, will establish and publish voluntary sector-specific cybersecurity performance goals.
3. Provide resources to incentivize and implement these cybersecurity practices.
4. The HHS will work with Congress to obtain new authority and funding to support hospital investments in cybersecurity.
5. Implement an HHS-wide strategy to support greater enforcement and accountability.
6. The HHS will work with hospitals to meet sector-specific cybersecurity performance goals in the coming years.
7. Expand and mature the one-stop shop within HHS for health care sector cybersecurity.
8. The HHS will mature its “one-stop shop” cybersecurity support function for the health care sector within the Administration of Strategic Preparedness and Response to more effectively enable industry to access the support and services the federal government has to offer.

Year after year, pathologists’ payments are being threatened to decline, workforce shortages are causing burnout, and cuts to clinical laboratory payments hang in the balance.

Be an advocate for pathology and plan to attend the Pathologists Leadership Summit in-person where you will gain unparalleled access to the education and training to make an impact on Capitol Hill and protect the future of our specialty.

The Pathologists Leadership Summit takes place, in-person only, April 13-16 in Washington, DC. Mark your calendars now and check Advocacy Update for a registration link in the coming weeks.

On December 7, the Center for Disease Control (CDC) issued a Health Alert Network (HAN) message about the occurrence, geographic spread, and sexually associated human-to-human transmission of Mpox cases in the Democratic Republic of the Congo (DRC). Clinicians and laboratories should be aware of suspected Mpox cases among individuals who have recently traveled to the DRC in the last 21 days. Contact your state public health laboratory to determine if a specimen should be forwarded for additional testing to determine the clade.

For more information, including recommendations for clinicians and laboratories involved in specimen submission or diagnostic testing, please review the HAN.

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