Advocacy Update

Read the Latest Issue of Advocacy Update

• CAP Calls on CMS to Fix Remote Work Rules for Pathologists; Congress Asked to Intervene
• Temporary Suspension of Laboratory Inspections Secured by the CAP
• CAP Advocates for Fair Coverage of COVID-19 Tests; $1 Billion to Test the Uninsured Secured
• CAP Successfully Advocates for Regulatory Relief for Pathologists with MIPS Deadline
• CAP Opposes New LDT Oversight Bill
• CAP Convenes Call with State Pathology Society Presidents for Briefing on COVID-19
• Want COVID-19 Breaking Advocacy News? Follow the Advocacy Twitter Channel
• March Advocacy News Quiz

The CAP has aggressively urged the Centers for Medicare & Medicaid Services (CMS) to allow pathologists and laboratory personnel to work remotely during the COVID-19 national emergency. Also, the CAP has engaged with Congress to support our request to remove such impediments to laboratory operations during the pandemic temporarily.

On March 20, the CAP sent formal letters urging top leaders in Congress to require the administration to fix the remote work rules. Letters were sent to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA), Minority Leader Kevin McCarthy (R-CA), Majority Leader Steny Hoyer (D-MD), and Steve Scalise (R-LA). The CAP hopes language could be adopted in supplemental legislation currently being debated in Congress.

The CAP supports the waiver from CLIA rules mandating pathologists to be on-site to review and diagnose their cases to protect the laboratory workforce. Given the relaxation of federal telehealth restrictions on other health professionals, the CAP has said it is critical that pathologists be given the discretion to work remotely. In addition, the CAP states that all laboratories should be given the discretion to determine what is best for their staff in managing this pandemic.

While the CAP made its case for the waiver, others have joined our effort. They include the American Hospital Association, American Medical Association, American Clinical Laboratory Association, Association of Pathology Chairs, and American Society of Clinical Pathology joining our cause. The CAP has also activated its grassroots network PathNet with CAP President Patrick Godbey, MD, FCAP, encouraging all CAP members to send messages to Capitol Hill and the Department of Health and Human Services (HHS).

After President Trump declared a national emergency, the CAP engaged with the HHS and CMS to request agencies waive provisions of law and regulation to give physicians and hospitals “maximum flexibility to respond to the virus.” As a result, the CMS on March 16 informed the CAP that it will suspend mandatory CLIA inspections for laboratories for three weeks beginning on March 17.

The CAP applauded this action by the CMS to waive routine inspections. This favorable decision will be evaluated on an ongoing basis and could potentially be extended depending on how the situation evolves. Read more about what this decision means to your laboratory.

As major legislation to assist physicians, hospitals, and patients with the COVID-19 pandemic, the CAP has engaged with lawmakers to ensure that all testing for COVID-19 should be covered without patient cost-sharing and to support $1 billion to pay for tests provided to patients without health insurance.

President Trump signed the Families First Coronavirus Response Act into law on March 19. The bill, first adopted in the House and then overwhelmingly passed the Senate, provides free COVID-19 testing, food aid, and paid sick leave for workers. The new law also requires Medicare, Medicare Advantage, Medicaid, and private health plans to provide coverage for COVID-19 diagnostic testing, including “the cost of a provider, urgent care center, and emergency room visits in order to receive testing.” Coverage must be provided at no cost to patients.

However, for private insurance plans, the law states coverage is for tests that have received an emergency use authorization by the Food and Drug Administration (FDA). This provision leaves out those tests that have yet to receive such authorization and tests regulated by state authorities, which the FDA is allowing.

The CAP is working to support another COVID-19 supplemental legislative package to clarify private insurance plans should cover all COVID-19 testing allowed by the FDA without cost-sharing for patients. Language in the new supplemental bill would resolve this issue and provide coverage for tests that have yet to obtain an emergency use authorization from the FDA.

The CAP was also supportive of funding provisions in the Families First Coronavirus Response Act. In summary, funding to cover the costs of diagnostic testing in public programs included:

• $1 billion for the National Disaster Medical System to reimburse laboratories providing services to individuals without health insurance
• $82 million for the Department of Defense and its Defense Health Program
• $64 million for the Indian Health Service and Urban Indian Health Organization
• $60 million for the Department of Veterans Affairs

The law also states Medicare should also waive beneficiary cost-sharing for physician and provider visits during which a COVID-19 diagnostic test is administered or ordered. Medicare already covers the COVID-19 diagnostic test.

On March 19, the CAP urged the CMS to give pathologists additional flexibility by extending its data submission deadline for the Merit-based Incentive Payment System (MIPS). And, just days later, on March 22 the CMS agreed to give pathologists and other physicians more time to complete their 2019 MIPS submissions by April 30. In addition, if pathologists are unable to submit their 2019 data by April 30, they will be “held harmless,” meaning that they will not be penalized but will instead receive a neutral payment adjustment.

The data submission deadline for MIPS eligible clinicians who participated in the 2019 performance period of the Quality Payment Program had been March 31. With pathologists and their laboratories on the frontlines of the pandemic, the CAP had asked the CMS for flexibility with existing deadlines and requirements, and to further take steps to ensure pathologists are not penalized due to the extreme costs of handling the pandemic. Pathologists must continue to focus their energy on patient care, said Jonathan Myles, MD, FCAP, who is chair of the CAP Council on Government and Professional Affairs, in a letter to CMS on March 19. 

“An extension of the MIPS data submission deadline would ensure that pathologists and their practices are able to focus their limited resources on providing care for their patients amid the COVID-19 pandemic,” Dr. Myles said.

The CAP remains engaged with federal agencies to minimize burdens on pathologists during the pandemic.

Following the introduction of the Verified Innovative Testing in American Laboratories Act of 2020 on March 18, the CAP announced its opposition to the bill citing concerns regarding patient safety and the redefinition of laboratory-developed tests (LDTs). 

“The CAP opposes the Verified Innovative Testing in American Laboratories Act of 2020 and any disruptive effort to redefine laboratory-developed tests during this national emergency,” said CAP President Patrick Godbey, MD, FCAP. “Presently, our efforts are focused on leveraging existing structures and streamlining processes to ensure increasing patient access to tests, while maintaining necessary safeguards. The CAP looks forward to engaging further with stakeholders on the oversight of laboratory-developed tests once we have moved past the COVID-19 pandemic.”

The CAP and a broad coalition of physicians, patients, and other key stakeholders, including federal agencies, have been working on drafting legislation focused on protecting patients and providing access to diagnostic tests under a regulatory framework that minimizes administrative burdens for laboratories. 

On March 5, a bipartisan and bicameral group of lawmakers introduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020. After the VALID Act’s introduction, the CAP said it viewed the latest version of the bill as a step forward in the right direction. The VALID Act would target the FDA’s oversight of LDTs and further instructed the government to ensure there is no duplication between CLIA and FDA requirements.

On March 26, the CAP will engage with state pathology society presidents to discuss their local issues and concerns during the COVID-19 pandemic.

In an email sent on March 20, CAP President Patrick Godbey, MD, FCAP, invited the presidents to participate in the forum to understand better how it is affecting them and members of their state societies. CAP leaders participating in the session will also discuss efforts the CAP is leading to advocate for the profession. The information gathered from presidents of state societies will help guide the CAP’s advocacy during this unprecedented challenge.

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