Advocacy Update

Read the Latest Issue of Advocacy Update

May 5, 2020

In this Issue:

FDA Outlines Additional Requirements for Serology Tests

Under new Food and Drug Administration (FDA) policy, commercial manufacturers will submit emergency use authorization requests, including their validation data, for serology tests for COVID-19. The FDA released this policy, which revised previous guidance, on May 4 following concerns regarding serology tests from the public.

Under prior policy, the FDA did not expect emergency use authorization submissions from commercial manufactures if the antibody test was validated, notification was provided to the FDA, and statements regarding the test’s limitations were included, the FDA said. As of May 4,12 antibody tests had been authorized under individual emergency use authorizations but there are hundreds more unregulated tests on the market.

The FDA is working with several federal agencies including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) to assess the performance of serological tests offered under its initial policy released March 16.

The FDA has designed a performance assessment protocol that offers evaluation of lateral flow SARS-CoV-2 serological tests rapidly in a laboratory environment. Under this protocol, each test submitted to the “umbrella pathway” will be evaluated with positive and negative plasma and serum samples. An “umbrella pathway” EUA will enable serology tests to be marketed after being put through an independent validation study at the National Cancer Institute or another designated government agency. The approach represents a balanced attempt to provide a reasonable understanding of the potential performance of a significant number of the tests within a short time period. Performance results can be included by the test developer in an emergency use authorization submission. The FDA set up the umbrella pathway to allow serology test developers to submit their tests to the National Institutes of Health’s National Cancer Institute, or another government agency designated by FDA, for independent validation.

CAP Provides More Details on $20 Billion Added to Provider Relief Fund

After the Department of Health and Human Services (HHS) released an additional $20 billion from its Provider Relief Fund for physicians and other providers enrolled in the Medicare program, the CAP received questions from its members about their eligibility to receive funding.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, allocated $100 billion for a Provider Relief Fund to help physicians and other health care entities that are responding to the coronavirus pandemic. Of that, $50 billion of the Provider Relief Fund is allocated for general distribution to Medicare facilities and providers impacted by COVID-19, based on eligible providers' net patient revenue. The initial $30 billion was distributed between April 10 and April 17, and the remaining $20 billion became available on April 24.

The relief funds are payments, not loans, to health care providers, and will not need to be repaid. However, providers must sign an attestation confirming receipt of the funds and agree to the terms and conditions within 30 days of payment. The CARES Act Provider Relief Fund Payment Attestation Portal is online here.

The CAP received several questions about how to verify eligibility and what to do when a physician believes they are eligible but did not receive a payment. Note that the funds are distributed at the tax identification number (TIN) level so employed physicians should not expect to receive an individual payment directly. The employer organization will receive the relief payment as the billing organization.

The HHS partnered with UnitedHealth Group (UHG) to deliver the payments, and physicians should contact UHG’s Provider Relief line at (866) 569-3522 about eligibility, whether a payment has been issued, and where it was sent. Note, if a physician or practice did not already set up direct deposit through the Centers for Medicare & Medicaid Services (CMS) or UHG’s Optum Pay, they would receive a check at a later date. Practices that would like to set up a direct deposit now can call the UHG Provider Relief number.

The CAP has additional financial resources on our COVID-19 webpage and the AMA has additional information available about the Provider Relief Fund on its website. The CAP will provide updated details as the HHS makes them available. More information is available at

With Shelter-In-Place Orders, CAP Members Talk to Congress Via Virtual Hill Meetings

To advocate for further assistance during the COVID-19 pandemic, the CAP organized virtual fly-ins with congressional offices. During these virtual “fly-ins,” which is either a video or phone call meeting with congressional staff, CAP members urged legislative staff to provide further financial and economic assistance to pathology practices as a result of the COVID-19 pandemic.

For instance, Chair of the Federal and State Affairs Committee David Gang, MD, FCAP did a virtual fly-in with Rep. Richie Neal’s (D-MA) staff on the House Ways & Means Committee on how Congress can provide pathologists with the economic relief needed for their practices and laboratories. Additionally, Sang Wu, MD, FCAP, and Simone Arvisais-Anhalt, MD, who is the resident member of the Federal and State Affairs Committee, also met with Sen. John Cornyn (R-TX). During these meetings, Drs. Gang, Wu, and Arvisais-Anhalt reinforced issues that the CAP wrote to congressional leaders that outlined actions lawmakers can take to provide pathologists with the economic relief needed for their practices and laboratories.

Specifically, during these meetings, CAP members asked Congress to:

  • Mitigate the CMS -8% payment cut to pathology services in 2021. Congress can stop this cut by waiving budget neutrality for Medicare changes to evaluation and management (E/M) services that will be implemented on January 1, 2021.
  • Increase funding for the Paycheck Protection Program and ensure adequate financial support for physicians and their practices.
  • Support residents and medical students by providing at least $20,000 of federal student loan forgiveness or $20,000 of tuition relief.
  • Adjust repayment provisions for the Medicare Accelerated and Advanced Payment program, including increasing the time to repay loans and reducing an interest rate.

The CAP will feature other members as virtual fly-in meetings continue during the pandemic.

If you are interested in meeting with your congressional member’s office virtually, please contact Lauren DePutter, CAP Director, Political Programs at

Massachusetts Pathologists Seek Changes to Bill That Establishes Arbitrary Out-of-Network Payment

The Massachusetts Society of Pathologists (MSP) is seeking changes to a proposed health care bill that could threaten payments to out-of-network physicians. The measure, An Act to Improve Health Care by Investing in Value, contains a raft of initiatives aimed at enhancing primary and behavioral health services while also attempting to control costs.

Specifically, the MSP noted in a March 21 letter that the legislation establishes an arbitrary out-of-network payment amount at an undefined percent of Medicare that is to be exclusively determined by the administrative fiat of the Health Policy Commission, a provision the state society opposes.

“Medicare is an inappropriate benchmark for payment by commercial insurers, and it would have dramatic adverse effects on the sustainability of many physician practices and health care institutions, ultimately jeopardizing access to care in many underserved areas,” said the MSP in comments submitted to the Joint Committee on Health Care Financing. “We oppose the use of Medicare rates alone and unadjusted as the default for out-of-network physician reimbursement.”

In terms of an appropriate methodology for out-of-network services, the MSP has endorsed a dual-pronged payment mechanism, which would pay non-emergency out-of-network providers the greater of: 1) 115% of the average rate the carrier pays for that service performed by a health care provider in the same or similar specialty, or 2) 125% of the Medicare rate for that services.

“The dual-pronged approach ensures that payment levels are sustained in order to maintain the financial viability of the health care delivery system, while recognizing the commercial value of services, including pathology services, as determined in the contracted marketplace between payers and providers,” said the MSP.

The society also asks for modification of a provision in the bill that precludes community-based physicians from billing for facility fee services provided at hospital laboratories, noting that the proposal places hospitals are a competitive disadvantage in providing certain technical services.

The CAP will continue to follow developments on this legislation.

Take the new May Advocacy News Quiz

Last month over 250 of your fellow members took the April news quiz. See how you compare against your fellow CAP members’ in the May News Quiz. Take the May news quiz.