POLICY BRIEFINGS

Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - AUGUST 31, 2020

CDC Receives Push Back on Latest Testing Guidance


The Centers for Disease Control and Prevention (CDC) has received strong criticism in recent days from public health stakeholders and lawmakers alike for its latest COVID-19 testing guidance. The updated guidance states that asymptomatic people do not need to be tested for COVID-19, even if they have been in contact with an infected individual, unless they are in a high-risk group or have been told to take a test by a health care provider. The CDC had previously recommended testing everyone who came in contact with an infected person. House Speaker Nancy Pelosi (D-Calif.) called the changes to the testing guidelines “scary and dangerous.” Rep. Michael Burgess (R-Texas), an OB/GYN and the Ranking Member of the Energy and Commerce Health Subcommittee, stated that asymptomatic testing for COVID-19 is paramount to getting the pandemic under control and to reopening schools and universities. A letter sent to Director Redfield led by Rep. Rosa DeLauro (D-Conn.) and signed by over 80 members of Congress condemns the updated guidelines, demands an explanation for the modifications, and urges an immediate halt to the testing guidelines. Groups representing nearly every public health department in the country also railed against the guidance, characterizing it as haphazard and calling on the CDC to reverse the change. The Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) issued a statement calling for the immediate reversal of the revision, stating that evidence “has clearly indicated that asymptomatic persons play a significant role in transmissions,” and that “identifying individuals infected with COVID-19— even if they are asymptomatic—is critical to support appropriate isolation and identification of contacts, to limit spread, and to provide the data-driven, comprehensive view of community spread needed to inform effective public health responses.” The Washington Post and The New York Times reported that the change was directed by the White House, an assertion that has been denied by the U.S. Department of Health and Human Services (HHS). Admiral Brett M. Giroir, the White House testing czar, credited CDC Director Robert Redfield for the policy shift and explained that it was made in response to concerns that people could receive misleading negative results if a test is administered too early.


Lawmakers Remained Deadlocked on COVID Relief


Congressional Democrats attempted to restart negotiations with the White House last week on a new coronavirus stimulus package, but the two sides remain deadlocked on the total size of the next relief bill. House Speaker Nancy Pelosi (D-Calif.) stated that she is willing to compromise on a $2.2 trillion package, leaving Republicans to increase their current offer by at least $1 trillion. White House Chief of Staff Mark Meadows stated that he does not expect an agreement to be reached until the government funding deadline at the end of the fiscal year on September 30.


Dingell, Upton Request Details on Convalescent Plasma Regulations


Reps. Debbie Dingell (D-Mich.) and Fred Upton (R-Mich.) have written to Commissioner of Food and Drugs Stephen Hahn requesting clarity about the requirements for the emergency use authorization (EUA) recently issued for convalescent plasma to treat COVID-19. The lawmakers cite concerns that the EUA adds a new unit labeling requirement that could be a barrier to use for certain convalescent plasma products distributed prior to the EUA issuance. They request that the Food and Drug Administration (FDA) take prompt action to ensure that these requirements do not unduly inhibit patient access to convalescent plasma


Democrats Probe Warp Speed’s Slaoui Contract


Rep. Pramila Jayapal (D-Wash.), and Sen. Elizabeth Warren (D-Mass.), and Sen. Richard Blumenthal (D-Conn.) have sent letters to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and third-party contractor Advanced Decision Vectors regarding the administration’s Operation Warp Speed COVID-19 vaccine project. Moncef Slaoui, an adviser on Operation Warp Speed, currently works on the project under a contract with Advanced Decision Vectors that was awarded by the administration for $1. The lawmakers request details on the full contract awarded to the company and information about the degree to which Moncef Slaoui is permitted to gain financially from his ties to the White House. “This unusual and complicated contractual arrangement for Dr. Slaoui appears to be a blatant attempt to skirt federal ethics law so that he can serve in this position without selling, or even disclosing the value of, his financial holdings and other possible conflicts of interest, using a loophole under which federal contractors are generally not subject to the same ethics laws and regulations that executive branch officers and employees must follow,” the letter states.



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