Advocacy Update

• Re-Watch Our LDT Final Rule Webinar and Download the Slides
• FDA Webinar on LDT Enforcement Policy June 5
• Members of Congress Introduce Legislation to Repeal LDT Final Rule
• CAP, AMA, and over 50 Health Care Organizations Urge HHS to Hold Change Healthcare Responsible for Reporting Requirements in Wake of Cyberattack
• Senate Committee Releases White Paper to Address Medicare Physician Payment Reform
• HHS Offering $50 Million to Help Protect Hospitals from Cyber Threats
• Take Our News Quiz for May

On May 23, the CAP held a webinar focused on the Food and Drug Administration’s (FDA) laboratory-developed tests (LDT) final rule. Over 1,300 members registered and close to 1,000 members attended the event which featured CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, FCAP; and Council on Scientific Affairs Chair Bobbi Pritt, MD, MS, FCAP. The presentation and discussion offer insights into the CAP’s initial analysis of the regulation, the timeline for implementation, the impact on laboratories and advocacy efforts around the regulation. If you missed the presentation, you can watch it here. Presentation slides are available for download here.

This is the first in a series of webinars and resources that the CAP will provide to members to help prepare for implementation of the rule in the months and years to come. The CAP is committed to meeting the needs of our members and advocating for the least burdensome regulation on pathologists. For the most updated information on LDT’s visit Regulatory Updates.

On June 5, the U.S. Food and Drug Administration (FDA) will host a webinar to provide an overview of two draft laboratory-developed test guidances:

• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency

During the webinar, the FDA will:

• Review the scope and key elements of each draft guidance.
• Provide responses to previously submitted questions.

If you have questions that you wish to submit for possible discussion during the webinar, email CDRHWebinars@fda.hhs.gov. All questions must be received by May 24 to be considered for the discussion.

Register here.

Reps. Brad Finstad (R-MN) and Dan Crenshaw (R-TX) introduced a resolution under the Congressional Review Act (CRA) to repeal the Food and Drug Administrations (FDA), laboratory-developed tests final rule in the House, the lawmakers said on May 17. Sen. Rand Paul (R-KY) introduced a companion resolution in the US Senate.

The Congressional Review Act allows Congress to effectively void rules declared by federal agencies. Due to its structure, however, it has rarely been successful, and it typically must be used when a new president from a different party than the predecessor enters the White House and the new president’s party also fully controls Congress. Currently, Republicans control the House and Democrats control the Senate and White House.

The CAP will monitor the progression of the resolution and bring you the latest developments.

On May 20, 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 21st.

In a letter, the groups asked for clarification around reporting responsibilities to assure affected providers that reporting, and notification obligations will be handled by Change Healthcare. They also asked OCR to publicly state that remediation after the breach will be focused on Change Healthcare, not the providers.

Under the HIPPA Breach Notification Rule covered entities and their business associates are required to notify affected individuals, the HHS and sometimes the media when unsecured protected health information is breached. UnitedHealth Group, Change’s parent company, previously said it would handle reporting to customers whose data may have been exposed.

On May 17, the Senate Committee on Finance released a white paper focused-on reforming Medicare’s payment system for physicians with goals of strengthening patient care. The CAP has proactively advocated for long-term solutions to Medicare’s payment system for physician services, including during the most recent Pathologists Leadership Summit.

In April, the Finance Committee held a hearing titled “Bolstering Chronic Care through Medicare Physician Payment” to discuss how to approach updating the Medicare physician payment system, and how to ensure the treatment and management of chronic conditions is at the center of the Medicare program. The CAP submitted a statement for the record to the committee in response to the hearing. In the statement, the CAP recommended policy solutions that senators can act on to help stabilize the physician payment system and grow the workforce.

The white paper outlined several areas that the committee sees as an opportunity for reform, including:

• Creating sustainable payment updates to ensure clinicians can own and operate their practices.
• Incentivizing alternative payment models that reward providing better care at a lower cost.
• Rethinking how Medicare measures quality care.
• Improving primary care.
• Supporting chronic care benefits in Medicare fee-for-service.
• Ensuring continued access to telehealth.

The Advanced Research Projects Agency for Health (ARPA-H), which is part of the Department of Health and Human Services (HHS), has announced a program called UPGRADE. UPGRADE is a federal investment of $50 million that will be allocated to organizations that can build tools to protect internet-connected hospital equipment from ransomware. HHS will disseminate “multiple awards” to those with the best pitches on how to detect weaknesses and deploy fixes with minimal interruptions to care delivery. The announcement of UPGRADE happened after two large healthcare cyberattacks on Change Healthcare and Ascension.

UPGRADE will bring together equipment manufacturers, cybersecurity experts, and hospital IT staff to develop a software suite for hospital cyber-resilience. There are no official dates for submission of proposals.

ARPA-H will host a Virtual Proposers’ Day via webcast on June 20, 2024, at Noon ET. The event will provide information on the ARPA-H UPGRADE program, address questions from potential proposers, and provide an opportunity for potential proposers to consider how their research and clinical efforts may align with the ARPA-H UPGRADE program objectives. Register here.

Click here for more information in the UPGRADE program.

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