Advocacy Update

• Medical Examiners: Funeral Assistance Available for Families Suffering Loss Related to COVID-19
• Congress Extends Paycheck Protection Program Deadline to May
• Advocacy Win: Two Autopsy Bills Supported by Mississippi Pathologists, CAP Signed Into Law
• Florida Pathologists, CAP Successfully Amend Genetic Privacy Bill
• Senate Passes CAP-Supported Moratorium on Medicare Cuts
• Updated Serology EUA COVID-19 Templates Available
• Last Week for the March Advocacy News Quiz
• CAP Urges Passage of Resident Physician Shortage Reduction Act
• Clinical Laboratory Test Data Reporting Delayed Until 2022

In early April, FEMA will begin providing financial assistance for funeral expenses incurred after January 20, 2020 for deaths related to coronavirus to help ease some of the financial stress and caused by the pandemic. The policy was finalized on March 24, and FEMA is implementing this funeral assistance program nationwide.

In some cases, medical examiners and coroners should anticipate receiving calls from families about why COVID-19 was not listed on a death certificate, FEMA said. They may also receive calls from clinicians about amending a death certificate.

An applicant may receive funeral assistance for actual funeral costs up to $9,000 for each COVID-19 related funeral. An applicant must be a US citizen, non-citizen national, or qualified alien who incurred funeral expenses after January 20, 2020. Currently, there is no deadline to apply. The official death certificate must attribute the death to COVID-19 and shows that the death occurred in the United States. The death certificate must indicate the death “may have been caused by” or “was likely the result of” COVID-19 or COVID-19-like symptoms. Similar phrases that indicate a high likelihood of COVID-19 are considered sufficient attribution.

FEMA has provided the following points to share with families and certifying clinicians as needed:

• Families who believe a death was due to COVID-19 but was not certified as such, should be referred to the person who certified the death. This person is responsible for any amendments. Funeral directors have been briefed on the assistance plan and are willing to help. Since they are aware of the rules and procedures in individual jurisdictions, they are a good resource to direct families to about specific reimbursement questions and death certificate procedures. Families will need a copy of the death certificate attributing the death to COVID-19, an itemized funeral expense receipt, and proof of other funds received (Required Documents).
• As most non-medical examiner, non-coroner death certifiers rarely amend death certificates, vital record offices should anticipate calls from certifiers about how to amend a certificate and may want to prepare guidelines for assistance.
• Families may not understand that just because a person tested positive for COVID-19 that this does not mean the person died from COVID-19. Viral COVID-19 RNA shedding has been detected for up to three months after the initial infection.
• In order for COVID-19 to be listed on the death certificate, the infection must have caused or contributed to death. There are circumstances in which “probable” may be used despite the absence of a positive COVID-19 test. (CDC Guidelines).
• Delayed COVID-19 deaths can be challenging. This scenario is similar to the approach for the certification of delayed traumatic deaths. If there is a direct pathologic link between the original infection and death, then the infection is included on the death certificate. The "but for" question may be useful. But for the COVID-19 infection, would this person have died at this time?

Congress passed a two-month extension of the Paycheck Protection Program for small businesses, including pathology practices, to apply for financial assistance, if needed.

This loan program created during the coronavirus pandemic was set to expire on March 31, but Congress agreed to give small businesses more time to apply and take advantage of the assistance. The program has a balance of $79 billion left after distributing hundreds of billions of dollars to companies.

For more information about the Paycheck Protection Program, visit the US Small Business Administration’s website.

Mississippi Gov. Tate Reeves signed two crucial forensic pathology laws that the Mississippi Association of Pathologists (MAP) and the CAP worked together on to protect the scope of practice for pathologists and eliminate regulatory burdens.

Gov. Reeves signed a new law alleviating autopsy images regulation that included an amendment that was advocated by the MAP and the CAP on March 24. The next day, Gov. Reeves signed a second bill into law that established a new position of “Medical Examiner Investigator,” which the MAP and CAP also successfully amended. The MAP and the CAP were concerned with the legislation’s newly created position’s ambiguous requirements and advocated for changes, such as rules that such individuals be supervised by a pathologist and only be limited to an assistant role. The CAP’s partnership with the MAP strengthened advocacy efforts in Mississippi to safeguard the value of pathology.

The MAP and the CAP had worked together to convince the Mississippi legislature to amend legislation to regulate the use of autopsy images. The amended legislation was based on the CAP policy on the Restrictions on the Use of Autopsy Materials, enacted by many other states nationwide. The new HB 70 law, regulates the use of autopsy images. The original bill would have prevented the use of autopsy photos without the decedent's family's consent. However, the long-standing CAP policy Restrictions on the Use of Autopsy Materials, which outlines the use of autopsy materials for medical, scientific, and law enforcement teaching or training purposes, provided the decedent's identity effectively concealed.

The MAP and the CAP secured an amendment to a second autopsy law that would establish a new position of “Medical Examiner Investigator.” The MAP and CAP attained an amendment to the Mississippi House Bill 974 requiring that the Medical Examiner Investigator position be appointed and trained, and be supervised, by the State Medical Examiner. The second law is a clear win for MAP and CAP as it secured amendments to protect the practice of pathology, pertaining to medical examiner investigator scope of practice.

The Florida Society of Pathologists (FSP), in coordination with the CAP, on March 24, successfully amended genetic privacy legislation (HB 833) in the Florida State House Judiciary Committee that would have made it a criminal felony to unlawfully disclose genetic information. The bill was intended to tighten privacy laws to preclude companies from commercializing consumer genetic information. To strengthen the profession of pathology nationwide, the CAP works with state pathology societies like the FSP to bolster local advocacy efforts that protect pathologists from increased or unnecessary burdens.

The FSP-CAP backed amendment exempts from the legislation DNA samples used for "medical diagnosis and treatment of a patient" when express consent was obtained by the physician who took the specimen or when the analysis was performed by a CLIA certified laboratory. The Florida legislation, and prior Florida law, provides an exclusive patient property right over DNA samples "with regard to the collection, use, retention, maintenance, disclosure, or destruction of such sample or analysis results." The pathology-backed amendment ensured that DNA samples can continue to be used for medical diagnosis and treatment for the benefit of patients, without legal impediment or legal jeopardy to pathologists or CLIA-certified clinical laboratories.

On March 25, the Senate passed CAP-supported legislation to prevent a 2% cut from hitting physician Medicare payments until the end of 2021. The 2% cut is set to take effect on April 1. The Senate legislation extends the Medicare sequester moratorium through the end of the year, but the bill does not include a House provision that would also stop additional sequester cuts created by the recently approved American Rescue Plan. The Senate legislation, which passed 90-2, will have to go back to the House for a vote once the lower chamber returns from recess in April.

In a March 15 letter, the CAP strongly supported bipartisan congressional action to stop the Medicare budget sequester cuts and provide critical relief for pathologists who have been on the front lines to fight the pandemic. Similar legislative measures have also been enacted during this health crisis. The bill passed by the House would extend a moratorium on the 2% Medicare sequestration cuts through the end of the declared public health emergency. It also fixes an issue with the recently passed American Rescue Plan Act of 2022 that is needed to prevent an additional 4% sequester cut that would be triggered in early 2022.

CAP Activates Grassroots Advocacy to Stop Cuts

The CAP is urging pathologists to write their elected officials and tell them to support the legislation. Using the CAP’s action center, it is easy for pathologists to contact members of Congress on this issue. Just login with your email and ZIP code to send messages to Congress in less than a minute.

The AMA, the CAP, and 127 medical and state organizations have also lobbied Congress to relieve the 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 CAP joined the groups to support legislation that would suspend a 2% across-the-board cut.

On March 17, the Food and Drug Administration (FDA) released two templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or pre-EUA submissions for COVID-19 serology tests, including one for serology tests that detect neutralizing antibodies. Additionally, the FDA updated serology template for test developers clarified recommendations regarding monitoring for and assessing the impact of new SARS-CoV-2 mutations and variants.

These FDA templates provide current recommendations concerning what data and information should be submitted to the FDA to support an EUA request or pre-EUA submission for SARS-CoV-2 antibody tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.

Download the new templates.

It’s the last week to take the March New Quiz. Last month, over 70 pathologists took the quiz and about 50% shared their results on social media. See how you compare against your fellow CAP members’ in the March News Quiz and share your results on social!

Take the News Quiz

The CAP strongly supports the bipartisan Resident Physician Shortage Reduction Act of 2021 introduced in the House and Senate. The legislation would expand the physician workforce and ensure patient access to physician services. The CAP called on Congress to pass the bill this year.

In two letters to the House and Senate bill co-sponsors, the CAP and nearly 70 medical, physician, and health care groups asked Congress to support the Resident Physician Shortage Reduction Act as a recent study indicated that a physician shortage in the US is coming. According to the Association of American Medical Colleges (AAMC), the United States could see a shortage of up to 139,000 physicians by 2033.

“This is particularly alarming given that more than two of five currently active physicians will be 65 or older within the next decade, raising concerns about the impact of physician retirement,” the letters stated. “Additionally, the US population is continuing to both grow and age, and access issues persist in rural and underserved areas.”

The vast majority of graduate medical education (GME) funding comes from the federal Medicare program. The Resident Physician Shortage Reduction Act of 2021 would gradually raise the number of Medicare-supported GME positions by 2,000 per year for seven years, for a total of 14,000 new slots.

The Centers for Medicare & Medicaid Services (CMS) reminded laboratories that statutory required reporting of private rates for Clinical Diagnostic Laboratory Tests (CDLTs) is delayed until 2022. During the pandemic, the CAP has advocated to reduce regulatory burdens on pathologists and the laboratories they lead.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted in 2020, made several revisions to the next data reporting period for CDLTs and the phase-in of payment reductions under the Medicare private payor rate-based clinical laboratory fee schedule (CLFS). The next data reporting period of January 1, 2022 through March 31, 2022 will be based on the original data collection period of January 1, 2019 through June 30, 2019.

Applicable laboratories must report data from the original collection period next year. Reporting would again resume on a 3-year cycle beginning in 2025.

For more information, see the CMS PAMA Regulations webpage.