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Quarterly Advocacy Update

Keeping you informed on policy issues affecting pathology and laboratory medicine.

Recap of the Latest Advocacy News from January-March 2022

In this Issue:

Senate Health Committee Advances PREVENT Pandemics Act

On March 15, the Senate Health, Education, Labor and Pensions (HELP) Committee approved the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT) Pandemics Act by a bipartisan vote of 20-2. The CAP advocated for and supported several provisions in the PREVENT Pandemics Act. Read more

Support Sought to Address Social Determinants of Health, Close Medicaid Coverage Gap

The CAP has asked Congress to address social determents of health and close the Medicaid coverage gap in its next government funding bill. The CAP is committed to achieving health equity in the US health care system and addressing health disparities to ensure quality, accessible patient care for all Americans. Read more

Responding to CAP and AMA Advocacy, ONC Broadens Definition of Harm in New Information Blocking FAQ

Following a request by the CAP and the American Medical Association to broaden the definition of potential harm, the National Coordinator for Health Information Technology office added new language to account for emotional and psychological harm in the agency’s information blocking regulations. Read more

Federal Judge Agrees with Physicians on No Surprises Act Lawsuit

A federal district court judge in Texas on February 23 vacated specific provisions pertaining to the independent dispute resolution process of the government’s regulations for the No Surprises Act. In a lawsuit filed by the Texas Medical Association, US District Court Judge Jeremy Kernodle granted the association’s motion for summary judgement and provided nationwide relief for all physicians and other health care providers who use the independent dispute resolution process. Read more

FDA Releases Blood Collection Tube Conservation Strategies

The US Food and Drug Administration (FDA) added all blood draw tubes to its medical device shortage list on January 19. The shortage stems from an increase in demand and vendor supply challenges during the COVID-19 public health emergency, the FDA said. The FDA action came after the CAP had also raised the shortage to the Department of Health and Human Services (HHS). Read more

CAP Urges CMS to Increase Transparency for Medical Coverage Determinations

The CAP and ten other health care professional organizations urged the Centers of Medicare & Medicaid Services (CMS) to increase transparency and clarify stakeholder engagement in the medical coverage determination process. The CAP has advocated for fair medical coverage changes to in the medical coverage determination process. Read more

HHS Releases Patient-Provider Dispute Resolution Guidance from No Surprises Act

The Department of Health of Human Services (HHS) released the No Surprises Act Patient-Provider Dispute Resolution guidance, which helps providers understand what information to include for the good-faith estimates. The CAP worked closely with Congress during the development of the No Surprises Act and advocated for patient protections, but has continually expressed the serious risks for patient harm and substantial difficulty in determining the cost of pathology services in advance of services conducted by the pathologist. Read more

Supreme Court Allows Vaccine Requirement for Health Care Workers

On January 13, the US Supreme Court upheld the Biden Administration COVID-19 vaccine requirement for health care workers, but struck down the vaccine mandate for private employers with 100 workers or more. The CAP has supported vaccine requirements for health care workers and encouraged Americans to get be fully vaccinated against the coronavirus. Read more

White House Urges Congress to Fund Strategic National Stockpile for Future Pandemics

On March 2, the Biden Administration announced it added personal protective equipment and diagnostic tests to the Strategic National Stockpile of medical equipment and further asked Congress for related funding. In its COVID-19 response strategy report, the Administration added at-home COVID-19 tests, antivirals, and masks to the Strategic National Stockpile, but needs additional funds from Congress to increase domestic vaccine and virus test manufacturing. The CAP has encouraged the Biden Administration to prepare for future public health emergencies, including shoring up the strategic national stockpile supply chains, global and domestic vaccine manufacturing, biosecurity, and therapeutics. Read more

UnitedHealthcare Responds to CAP About Designated Provider Program Concerns

UnitedHealthcare responded to the CAP’s and six other medical professional organizations’ objections to the insurer’s Designated Diagnostic Provider program. The groups had asked UnitedHealthcare to withdraw the updated program as it continues to undermine the patient-physician relationship, despite recent changes. The CAP works with private-sector insurers, like UnitedHealthcare, to safeguard access to pathology and laboratory services for patients across all settings. Read more

Kentucky Pathologists, CAP Urge Protections for Test Results Legislation

On March 10, the Kentucky Society of Pathologists (KSP) and the CAP urged the Kentucky legislature to amend House Bill 529 to remove legal non-compliance risk to pathologists and clinical laboratories under the 21st Century Cures Act and related rules. The CAP works with state pathology societies to ensure legal protections for pathologists and laboratories regarding certain diagnostic testing delays. Read more

Washington Legislature Passes WSSP-CAP Amended Out-of-Network Law

On March 7, the Washington state house passed House Bill 1688, providing greater alignment between Washington’s Balance Billing Protection Act (BBPA) with the federal No Surprises Act. In collaboration with the CAP, the Washington State Society of Pathologists (WSSP) partnered with the Washington State Medical Association (WSMA) to include provisions to strengthen network adequacy review of health insurance plans by the Department of Insurance. The CAP advocates for states to require health plans to have adequate networks of hospital-based physicians, including pathologists. Read more

Georgia Association of Pathology and CAP Oppose Pathologists’ Assistants Licensure Bill

On February 17, the Georgia Association of Pathology (GAP) and the CAP submitted a memorandum of opposition to Senate Bill 525, which would establish licensure for pathologists’ assistants. The CAP works with state pathology societies to oppose state licensure for pathologists’ assistants, cytotechnologists, and histotechnologists in accordance with CAP’s model criteria for the state licensure of clinical laboratory personnel. Read more

New Hampshire Pathologists Advocate to Uphold State Out-of-Network Law

On February 2, the New Hampshire Society of Pathologists (NHSP), with support from the CAP, testified during a state Senate Health and Human Services Committee hearing to amend Senate Bill 287, which would align the state’s out-of-network law with the federal No Surprises Act. The NHSP and the CAP have actively worked with the New Hampshire Medical Society on the bill to amplify pathologists’ concerns. Read more

No Surprises Act Supersedes Adverse Indiana Out-Of-Network Law

A 2020 Indiana out-of-network balance billing law, that was strongly opposed by the Indiana Society of Pathologists and the CAP, was deemed by the CMS as not meeting the standards established by the federal “No Surprises Act.” Accordingly, the No Surprises Act, which took effect on January 1, 2022, will supersede the Indiana out-of-network law. Read more

Transition News

Robert Califf Confirmed as FDA Commissioner

Robert Califf, MD, a cardiologist, was confirmed by the Senate on February 15 as the Commissioner for the FDA. Dr. Califf will lead the FDA, which is the regulatory agency overseeing pharmaceuticals and medical devices. Read more