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 - APRIL 18, 2022

HHS Extends PHE Declaration


U.S. Department of Health and Human Secretary Xavier Becerra has extended the COVID-19 public health emergency (PHE) declaration for another 90 days. The nation is currently grappling with rising cases of the Omicron subvariant BA.2. The PHE renewal will allow policies like expanded telehealth flexibilities and Medicaid coverage protections instituted in response to the pandemic to continue through at least July. The administration has pledged to provide at least 60 days notice before terminating the PHE. The U.S. is still averaging 30,000 new COVID-19 cases each day, but hospitalizations and death rates are on the decline, averaging approximately 1,400 and 500 per day respectively. Roughly 82% of eligible Americans have received at least one COVID-19 shot.


FDA Issues EUA for COVID-19 Breath Test


On Thursday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the InspectIR COVID-19 Breathalyzer. The rapid diagnostic detects COVID-19 using breath from individuals aged 18 years and older. It may be used on individuals regardless of whether they are experiencing symptoms. Testing is “limited to use by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests in an environment where the patient specimen is both collected and analyzed.”


Lawmakers Push OTC Status for Naloxone


Agroup of 30 lawmakers in the Senate and House of Representatives are pushing Pfizer, Teva Pharmaceuticals, Hikma, Emergent BioSolutions, Amphastar Pharmaceuticals, and Adamis Pharmaceuticals to apply for over-the-counter (OTC) status for their respective naloxone products. Their letters to the companies argue that the OTC status of the opioid overdose reversal drug will reduce the stigma around addiction and drug-related death. “The COVID-19 pandemic has dramatically exacerbated the opioid and substance use disorder epidemic in this country, with reported overdoses and deaths spiking to historic levels,” the letter states. “It has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale. This includes steps to increase access to affordable naloxone, which is a proven, effective tool to reduce medical emergencies, drug overdoses, and deaths.” The lawmakers assert that the Food and Drug Administration “strongly supports” OTC naloxone, but that it is the company’s responsibility to submit the required paperwork.


Timeline for Marijuana Bill Slips to Summer


Senate Majority Leader Chuck Schumer (D-N.Y.), Senate Finance Committee Chair Ron Wyden (D-Ore.), and Sen. Cory Booker (D-N.J.) have confirmed that legislation to establish a federal standard for cannabis legalization and regulation is on track to be introduced before the August recess. The lawmakers had previously announced plans to file a bill sometime this month. The House of Representatives passed H.R. 3617, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, to remove marijuana from the federal controlled substances list, earlier this month by a vote of 220-204.


More Breakthrough Cases on Capitol Hill


Six more lawmakers have tested positive for COVID-19 in the ongoing series of breakthrough cases of the virus on Capitol Hill. Reps. Raja Krishnamoorthi (D-Ill.), Earl Blumenauer (D-Ore.), Frank Pallone Jr. (D-N.J.), Lisa Blunt Rochester (D-Del.), Elaine Luria (D-Va.), and Rashida Tlaib (D-Mich.) have all announced positive COVID-19 test results in recent days. Each member of Congress was fully vaccinated and boosted.


Lisa Barclay to Service as COVID Response Coordinator Deputy


The White House has announced the appointment of Lisa Barclay to assume the role of deputy COVID-19 response coordinator. Barclay currently serves as a top lawyer at the U.S. Department of Health and Human Services covering Food and Drug Administration and COVID-19 issues. In her new position, she will work under Ashish Jha, MD, MPH, who recently started as the White House’s COVID-19 response coordinator. Jha and Barclay replace Jeff Zients and Natalie Quillian, respectively.


FTC Extends PBM Comment Deadline


The Federal Trade Commission (FTC) has extended its public comment period on the practices of pharmacy benefit managers (PBMs) until May 25. The agency is seeking information on PBM rebates and contracts and their impact on the cost of drugs for patients. The request for information was opened in February, following a Commission deadlock vote about whether the FTC should study the competitive impact of PBM practices.


ACIP to Meet This Week on COVID Boosters


The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on April 20 to discuss COVID-19 booster recommendations. The meeting follows a discussion amongst the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee that did not result in a formal recommendation on the administration of another round of booster shots, if necessary, this fall. Both the FDA and the CDC have already cleared a second booster dose of the Pfizer-BioNTech and Moderna vaccines for adults aged 50 and older and individuals aged 12 and older with weak immunity.



April 18, 2022: | Page 1 Page 2

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