Advocacy Update

• CAP Supports COVID-19 Package Providing $46 Billion for Testing
• CAP to Meet with UnitedHealthcare Regarding Designated Diagnostic Provider Program
• AMA, CAP Urge Congress to Delay Medicare Budget Sequester
• Arizona Pathologists, CAP Secures Amendment in Genetic Testing Legislation
• Take the February Advocacy News Quiz

The CAP urged a key health care committee in the House to increase testing resources and expand laboratory capacity for COVID-19 tests in its next pandemic relief package. In a letter to House Energy and Commerce Committee leaders, the CAP reiterated its concerns regarding persistent shortages of testing supplies and the need for additional assistance to fight this pandemic. On February 11, the House Energy and Commerce Committee marked up the bill, which aims to provide greater federal assistance for COVID-19 testing.

The Energy and Commerce Committee completed its work marking up and amending its portion of the package on February 11. The House Ways and Means Committee also concluded its work on the legislation on February 11.

The proposed $1.9 trillion COVID-19 relief package includes several economic and health care-related provisions, including more than $50 billion for vaccines. The legislation would also give the Department of Health and Human Services (HHS) $46 billion for testing programs, including creating a national strategy and contact tracing of COVID-19.

“Specifically, the CAP supports the committee’s inclusion of $46 billion in funding for COVID-19 testing and the implementation of a testing strategy that supports investments in laboratory capacity,” wrote CAP President Patrick Godbey, MD, FCAP, in the letter to the Energy and Commerce Committee. “In addition to the specified activities outlined by the committee, we would emphasize that these funds should be used for a broad range of tests, including SARS-CoV-2 nucleic acid tests, for a variety of communities and practice settings.”

Throughout the pandemic, the CAP has surveyed laboratory directors who reported that more testing could be done if they had all the necessary supplies. Laboratory directors have cited problems acquiring testing supplies, particularly test kits, plastic pipette tips, specimen acquisition swabs, and transport media, as the greatest barriers to increased testing.

The CAP has also engaged with the Biden administration as it counters the COVID-19 pandemic, especially those elements of the new strategy concerning diagnostic testing.

UnitedHealthcare recently announced a new program impacting outpatient laboratory services for fully insured commercial members. Effective July 1, 2021, the insurer will only cover outpatient laboratory services for members when delivered by a “Designated Diagnostic Provider” laboratory. Concerns regarding the new program resulted in the CAP securing a meeting with UHC on February 19 to request more information and advocate for pathologists and laboratories across all settings. The CAP engages with private payers to protect access to pathology services for patients, and ensure pathologists can practice without excessive burdens or interference with the practice of medicine.

Starting July 1, laboratories that are not a “Designated Diagnostic Provider” will remain in-network, but outpatient diagnostic laboratory services will be denied as non-covered. UnitedHealthcare sent communications to all diagnostic providers to encourage them to become a Designated Diagnostic Provider by completing a quality questionnaire by February 28.

UnitedHealthcare did notify the CAP of the upcoming reimbursement policy change in a January 4 letter. The CAP will share additional information as it is available. Visit the CAP’s private sector advocacy webpage for more information.

The American Medical Association (AMA), the CAP, and 127 medical and state organizations lobbied Congress to relieve financial burdens of the COVID-19 pandemic on physicians during the current national emergency. In a February 12 letter to congressional leaders in the House and the Senate, the group supported legislation that would suspend a 2% across-the-board Medicare budget sequester cut for the duration of the COVID-19 public health emergency. The CAP has supported similar efforts over the past year to stop Medicare cuts and protect pathology services' value. Without additional action, the 2% Medicare cut to physician services will go into effect on April 1.

In the letter, the groups urged congressional leaders to take legislative action. “With the March 31 deadline looming, it is critical for Congress to take immediate steps to further postpone the imposition of the Medicare sequester. We, therefore, strongly urge you to pass HR 315, the Medicare Sequester COVID Moratorium Act—bipartisan legislation that would continue the current Medicare sequester moratorium for the duration of the [public health emergency].”

Reps. Brad Schneider (D-IL) and David McKinley (R-WV) introduced the Medicare Sequester COVID Moratorium Act on
January 29. Previously, Congress postponed the budget sequester until March 31 in its large spending bill enacted during the final days of 2020. A 2021 moratorium on the budget sequester is being championed by the AMA and other physician associations representing specialties like the CAP.

The Arizona Society and Pathologists (ASP) and the CAP successfully amended state legislation to protect Arizona pathologists’ scope of practice who conduct genetic testing. The amendment included in the state house bill proposes to regulate non-medical testing with no impact on medical genetic testing, which would cause legal confusion and increase reporting burdens for Arizona pathologists. The amendment will protect pathologists from great legal confusion and regulatory burdens in Arizona.

In a letter to Arizona state house leadership, ASP President Richard Eisen, MD, FCAP, reiterated how “the bill intends to regulate non-medical testing, such as genetic tests offered from private companies (like 23andme Inc.) and not to impact medical genetic testing which is now the standard of care for diagnosing and evaluating appropriate cancer therapies and other complex diseases.” The ASP and the CAP secured an amendment to the bill clarifying that genetic testing will be the exclusive property of the person testing and only when it is “not the subject to the federal health insurance portability and accountability act of 1996.”

Direct to consumer tests fall outside the scope of HIPAA and the regulation of medical information outside of the traditional health care context. Both the CAP and the ASP were concerned about bill’s intent and impact on medical genetic testing when physicians, clinical laboratories, and other entities retain and rely on genetic testing specimens and its clinical information to help patients.

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