Advocacy Update

Read the Latest Issue of Advocacy Update

• HHS Appoints CAP President Dr. Patrick Godbey to its National Testing Forum
• CAP Reiterates to HHS to Rescind COVID-19 Data Reporting Rules for Labs
• The CAP, Orthopaedic Surgeons Urge Congress to Pass Eliminating Provider Relief Fund Tax Penalties Act
• FDA Relaxes Emergency Use Authorization Requirement for COVID-19 LDTs, Draws Criticism from Congress
• HHS Shares Email Address to Request Swabs, Transport Media
• Eligible Pathologists Can Apply for Phase 2 Provider Relief Funds
• Last Week to Take August Advocacy News Quiz

Given the CAP’s important role in the country’s response to the pandemic, the Department of Health and Human Services (HHS) appointed CAP President Patrick Godbey, MD, FCAP to its National Testing Implementation Forum.

The HHS created the forum program in late July to capture feedback between federal officials and the private sector and bring together representatives from key stakeholder groups to share information and provide input to federal leaders about SARS-CoV-2, the virus that causes COVID-19, testing and diagnostics.

"This is an important initiative to improve collaboration in the advancement of innovation in SARS-CoV-2 testing," said ADM Brett Giroir, MD, the HHS assistant secretary for health in July. "Gaining private sector input is critical, bringing novel technologies into widespread use by the public health and commercial sectors."

Key issues that Dr. Godbey will address include those affecting the supply chain for testing and guiding optimal testing for various settings, such as those involving symptomatic and asymptomatic testing.

According to HHS, the forum will aim to significantly increase public health laboratory capacity and implement a national surveillance strategy using CLIA and non-CLIA assets. The forum will seek new techniques and technologies, such as sample pooling and identify any barriers to a streamlined national laboratory testing reporting system and defined reporting standards. The forum will also improve technical assistance across the nation to target testing among the vulnerable and underserved and create a sustainable diagnostics ecosystem that is sustainable and fully capable of future public health challenges.

During a follow-up meeting with federal agency officials on August 19, CAP leaders reiterated to the HHS and Centers for Disease Control and Prevention (CDC) to rescind new data reporting requirements for laboratories until workable rules are developed.

CAP President Patrick Godbey MD, FCAP, CAP Governors Jonathan Myles, MD, FCAP and Rajesh Dash, MD, FCAP, and informatics experts Alexis Byrne Carter, MD, FCAP, and Joseph Sirintrapun, MD, FCAP, again met with the HHS and the CDC officials to urge the agencies to withdraw or amend COVID-19 reporting requirements until workable rules are developed and implemented.

Some workable rules the CAP would like implemented for laboratory data reporting is a phased-in approach with some flexibility to implement such a complex reporting system. By taking a phased-in approach, the HHS and the CDC can obtain the necessary data to conduct surveillance and contact tracing for COVID-19 while not overburdening clinical laboratories and front-line clinicians.

Additionally, laboratories should only report the results of tests that they perform in-house. The CAP recommends that laboratories should report to the state or local public health department for the state or locale where the laboratory is located. Moreover, the CAP seeks that laboratory reporting should not be based on the patient's residence or the location of the ordering provider’s office. The government should not mandate how the data requested is obtained.

This meeting was a follow-up to the August 6 meeting where these CAP leaders first discussed the reporting issue on laboratories.

The CAP, along with the American Academy of Orthopaedic Surgeons and other medical specialty groups asked Congress to support Eliminating Provider Relief Fund Tax Penalties Act of 2020. In a letter to both House and Senate members, the group urged for tax relief from the allocation of $175 billion in financial relief provided to healthcare professionals through the Public Health and Social Services Emergency Fund. The passage of the Eliminating the Provider Relief Fund Tax Penalties Act would ensure that all Provider Relief Fund assistance is non-taxable and maintains that expenses tied to the assistance are tax deductible.

The group further discussed that while Provider Relief Fund “has provided vital relief for our members, we all know that the full relief amount is needed as a result of medical practice shutdowns during the COVID-19.”

Currently, the Public Health and Social Services Emergency Fund assistance is taxable, resulting in a 21% or more reduction in the benefit for taxpaying providers compared to non-taxpaying providers. The group asked that Congress consider tax relief when this funding is passed for health care providers.

In a rescission of previous guidance, the Food and Drug Administration (FDA) will no longer require an emergency use authorization (EUA) of laboratory-developed tests (LDTs) for patients, including those include those used to diagnose COVID-19. Additionally, the FDA changed the current enforcement discretion policy unless Congress takes action, which would allow stakeholders to comment before it takes effect.

A notice published by the Department of Health and Human Services (HHS) on August 20 relaxed the FDA rules, which had been in place since late February.

It mandated that the FDA undergo notice-and-comment rulemaking for premarket or EUA review of LDTs in the future. This notice outlined the process to relax regulatory requirements.

However, members of Congress are demanding a briefing from the HHS on this decision to relax these rules. US House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) criticized the action to relax these rules. “Given the importance of testing for our ability to control the spread of COVID-19 and the Administration’s past blunders with serological tests, I do not believe that now is the time to reduce oversight of COVID-19 tests. The Trump Administration has continuously failed to grasp the scope of this pandemic. Flooding the market with unregulated and potentially inaccurate tests will only further undermine our nation’s response efforts,” Congressman Pallone stated.

The HHS announced it is directly managing the allocation of swabs and media, including viral transport medium (VTM), based on state and territory testing plans that were submitted in response to the Coronavirus Aid, Relief, and Economic Security (CARES) Act requirements. Allocations were predetermined to maximize state and territory testing using a data-driven algorithm based on population, high incidence areas, and COVID-19 Task Force’s directives.

The HHS is currently distributing the following swabs: nasopharyngeal (NP), nasal, foam, and poly swabs. The HHS is distributing the following media: saline, phosphate-buffered saline solution, and VTM. For specific swab or medium requests, delivery site changes, or other related requests, contact COVID19TestSupplies@hhs.gov.

On August 10, the HHS announced that certain pathologists are eligible for Provider Relief Fund Phase 2 payments. Eligible pathologists will only receive funding of up to two percent of their reported total revenue from patient care.

Eligible pathologists may apply for Phase 2 General Distribution payments if they:

• Were ineligible for the Phase 1 because they underwent an ownership change in 2019 or 2020 under Medicare Part A, and did not have Medicare Fee-For-Service revenue in 2019.
• Received a payment under the Phase 1 who either missed the June 3 application deadline or did not receive Phase 1 General Distribution payments totaling approximately two percent (2%) of their annual patient revenue.
• Previously received Phase 1 payments, but rejected and returned the funds and now want to reapply.

Pathologists who have already received and retained Phase 1 payments from the HHS, those payments will be taken into account when determining their eligible amount for Phase 2 payments. All providers must accept the HHS’ Terms and Conditions, and are subject to possible audit regarding the accuracy of the data they provided to the HHS.

Additionally, eligible pathologists who want to apply must not currently be terminated from participation in Medicare, or precluded from receiving payment through Medicare Advantage or Part D. To apply eligible pathologists must include their TIN billing number. The deadline for eligible providers to apply for such payments is August 28, 2020.

If you think you qualify for this round of funding please submit an application HERE. If you have any questions regarding the Provider Relief Fund Program, visit hhs.gov/providerrelief.

It is the last week to take this month’s Advocacy News Quiz. Last month over 100 CAP members took the July news quiz. See how you compare against your fellow CAP members’ in this month.

Take the August news quiz