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Recap of the Latest Advocacy News from January-March 2024
In this Issue:
Congressional News
CAP President Testifies During Congressional Hearing on Oversight of Laboratory-Developed Tests
On March 21, CAP President Donald Karcher, MD, FCAP, provided testimony to the House Energy and Commerce Subcommittee on Health during a hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule.” Dr. Karcher firmly stated the CAP’s opposition to the Food and Drug Administration proposed regulation on the oversight of laboratory-developed tests (LDTs) and advocated for policy solutions that target full regulation of only the highest risk LDTs. Read more
CAP Advocates to Pass Inflation-Based Medicare Payment Fix
The CAP, the American Medical Association, and over 130 medical professional societies asked Congress to pass legislation that provides an annual inflation-based payment update based on the full Medicare Economic Index (MEI). The MEI index legislation would be an inflation-based update solution to the ongoing problems plaguing the Medicare Physician Fee Schedule and ongoing Medicare payment cuts to all physicians. The CAP continues to fight for fair pay for the value pathologists provide. Read more
Over 300 Pathologists Encourage Senators to Reverse January 1 Cuts to Medicare Pay
Over 300 pathologists responded to an Action Alert by the CAP sent to its grassroots advocacy network encouraging outreach to their legislators to sign a Dear Colleague Letter drafted by Sens. John Boozman (R-AR) and Peter Welch (D-VT). The letter, sent to Senate leadership on February 22, emphasized the urgent need to address the 3.37% cut to Medicare physician payments that went into effect January 1. Thirty-two senators signed the letter. Read more
CAP and over 50 Physician Groups Urge Lawmakers to Mitigate Health Care Workforce Shortage
The CAP and more than 50 physician and health care groups strongly urged Congress to support the Healthcare Workforce Resilience Act. In a February 27 letter to the House and Senate, the groups said the United States is facing an urgent health care workforce shortage that is expected to get worse over the next decade. This legislation would initiate a one-time recapture of up to 40,000 unused employment-based visas – 25,000 for foreign-born nurses and 15,000 for foreign-born physicians – so they can strengthen and provide stability to the US health care system. The legislation would also allow for thousands of international physicians who are currently working in this country on temporary visas with approved immigrant petitions to adjust their status. Read more
Congress Passes Bill Giving Pathologists $19.1 Million in Additional Medicare Payment Relief through 2024
On March 8, Congress passed the 2024 Consolidated Appropriations Act that included additional relief from Medicare payment cuts. Physicians will receive a boost in Medicare pay for patient services starting from the legislation’s enactment through the end of 2024. This new relief equates to $19.1 million dollars for pathologists as the legislation increases Medicare pay for the remainder of the year by 1.68%, meaning that overall pathology pay would increase over current 2024 levels while still being 1.04% lower in 2024 compared to last year. Throughout 2023 and early 2024, the CAP persistently lobbied lawmakers to enact short-term Medicare payment relief. Medicare’s payment formula had cut pathology services by 2.72% in 2024 while some other physician specialties faced higher reductions. Read more
Medicare and Federal Health Care News
CAP Supports the Restructuring of the Independent Dispute Resolution Process
In a January 2 letter, the CAP urged the Department of Health and Human Services (HHS), jointly with the departments of Labor and the Treasury, to move forward with new disclosure requirements, centralizing the open negotiations process, increasing flexibility around batching, and promoting equitable access to IDR for low-dollar disputes. The CAP also encouraged the departments to increase the ease of submitting a formal complaint against an insurer and to strengthen enforcement, including financial penalties, of No Surprises Act dispute resolution requirements. Read more
CAP Applauds CMS Prior Authorization Rule Prioritizing Patients’ Access to Care
On January 18, the CMS released a final rule that makes important reforms in prior authorization programs for medical services. The rule is a direct result of important advocacy efforts taken by the CAP together with the American Medical Association and other physician organizations to addresses prior authorization in government-regulated health plans. On March 13, 2023, the CAP wrote a letter to the CMS asking them to streamline the prior authorization process, reduce physician practice burdens, and prevent patient care delays in Medicare Advantage and other public health plans. Read more
FDA’s CDRH Announces Reclassification Process for Most High Risk IVD
On February 1, the Food and Drug Administration’s Center for Devices and Radiological Health announced it started the reclassification process for most in vitro diagnostics (IVDs) that are currently class III (high risk) into class II (moderate risk). The majority of these tests are infectious disease and companion diagnostic IVDs. Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510 (k) premarket notification pathway) rather than the premarket approval pathway, the most stringent type of FDA medical device review. Read more
Key Histocompatibility, Personnel, and Sanction Revisions in CLIA Updates Rule
In late December, the CMS finalized a regulation adopting a new fee structure and CLIA updates proposals concerning histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories. In total, CLIA covers about 320,000 laboratories, and the CLIA program's objective is to ensure quality laboratory testing. These are the first significant updates to the CLIA regulations since its inception in 1992. Some changes within the rule are meant to provide more flexibility for clinical testing under CLIA. The rule also clarifies confusing provisions and removes grandfathered and other obsolete personnel degrees along with practices. Read more
CAP Urges CMS to Revise Flawed LCD Process
The CAP has repeatedly appealed to the CMS to remedy significant issues with the local coverage determination (LCD) decision-making process. The CAP believes that the elements critical to ensuring sound local coverage policy have been compromised as a result of CMS’ October 2018 revisions to the LCD guidelines. In a February 23 letter to the CMS, the CAP made numerous recommendations like increased transparency, public disclosures of information and public notice and comment before changes take effect. Read more
Private Payor News
CAP Advocacy Win: Wellmark BCBS Rescinds Blanket Denials for Certain Pathology Tests
As a result of CAP advocacy, the private insurer Wellmark Blue Cross Blue Shield is rescinding provisions of their immunohistochemistry (IHC) policy that limited coverage with blanket reimbursement denials of IHC when the claim includes certain ICD 10 codes. On January 30, Wellmark notified the CAP it would rescind medical necessity reviews of IHC, and reverse prior adverse determinations processed under the policy effective October 1, 2023. The policy had affected pathologists and laboratories practicing in Iowa and South Dakota. Read more
Quality News
Pathologists Quality Registry Earns 2024 Approval and 3 New Measures to Improve Practice Performance, Payment
The CAP’s Pathologists Quality Registry once again received approval and its qualified clinical data registry status from the Centers for Medicare & Medicaid Services (CMS). This recognizes our registry’s ability to improve care for patients and collect quality data to submit for the Merit-based Incentive Payment System (MIPS). The Pathologists Quality Registry reduces pathologists’ burdens when participating in MIPS by providing practice-specific guidance, consolidating reporting for both the Quality and the Improvement Activities categories, and providing pathology practices with real-time performance benchmark reports. Read more
Pathologists Quality Registry by the CAP Earns Historic Benchmarks from CMS
The Center for Medicare and Medicaid Services (CMS) alerted the CAP that its Pathologists Quality Registry earned historical benchmarks for two more of their registry-specific Qualified Clinical Data Registry (QCDR) measures. This brings the total benchmarked QCDR measures to four. Benchmarking is critical for pathologists looking to maximize their scores while minimizing burden. Read more
State News
CSP and CAP Support Amending Medicaid Bill to Ensure Access for Pathology Patients
The Connecticut Society of Pathologists (CSP), with CAP support, urged the amending of Raised Bill 5459, to expressly include pathology and laboratory medicine under the category of "select providers." The current legislation omitted pathology and laboratory services from the definition of "select providers" that would benefit from a new rate methodology that would adjust Medicaid rates "to a specified percentage of Medicare for the same service." The CSP noted that pathology and laboratory services were included in a state issued report, released in February that found significant disparities in payment for pathology and laboratory services in the state Medicaid program when compared with a sample of five other states and Medicare. Read more
CAP and Maryland Pathologists Successful in Blocking Written Estimate Bill
The Maryland Society of Pathologists (MSP), with the support of CAP, effectively blocked consideration of legislation that would have required written estimates of services, prior to performing the service, and patient consent on all out-of-network pathology and laboratory services. House Bill 1148 /Senate Bill 1104, was introduced at the request of the Maryland Attorney General and has been formally withdrawn. Read more