Insights^

Becerra Authorizes FDA to Issue EUAs for Monkeypox Tests

Health and Human Services (HHS) Secretary Xavier Becerra issued an emergency declaration on Wednesday to allow the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) for monkeypox tests.  The announcement comes one month after HHS declared monkeypox to be a public health emergency.  According to Becerra, the declaration will help propel the government’s response to monkeypox by expanding access to testing.  In a separate announcement, the FDA issued its first EUA for a monkeypox test to Quest Diagnostics.  While the US is currently conducting more than 80,000 tests per week, some experts warn confusion over where patients get tests could be limiting access to monkeypox tests.

White House Pushes for COVID-19 Funding in CR

The Biden administration is pushing Congress to include $22.4 billion in a continuing resolution (CR) to help the domestic fight against COVID-19.  Due to dwindling funds, the administration has already announced it will no longer send free COVID-19 tests to people’s homes, and federal funding for COVID-19 vaccines is likely to end soon.  Additionally, the White House has communicated that it has no objection to attaching the reauthorization of FDA user fees to a CR, although the administration declined to offer its outright support for the proposal.   However, the likelihood that either proposal makes it into a CR is uncertain, as congressional appropriations leaders are currently hashing out whether to include Democratic energy policies in a stopgap spending measure.  Even if Congress is able to quickly pass a CR later this month, lawmakers could become embroiled in another appropriations fight later this year when the CR is expected to end.

Study: Private Equity-Owned Practices Leave Patients with Higher Bills

Physician practices acquired by private equity firms were associated with higher spending and more patient visits, according to a study published by the Journal of the American Medical Association.  The study found an average increase of 20%, or $71, in charges per claim, and 11%, or $24, in amount allowed per claim.  Private equity-owned practices were also reported to have about 26% more unique patients.  According to a press release by the study’s authors, the higher billing could be due to either more efficient documentation of services or up-coding/up-charging to insurance companies.   The study only examined dermatology, gastroenterology and ophthalmology medical practices purchased by private equity.

Federal Judge Rules HIV Drug Coverage Requirement Violates Religious Freedom

On Wednesday, US District Judge Reed O’Connor ruled that requiring employers to provide the HIV prevention drug PrEP violates their religious freedom, potentially jeopardizing the mandatory coverage of preventative health care services under the Affordable Care Act (ACA).   According to the Texas employers behind the suit, the provision violates the Religious Freedom Restoration Act by forcing people to pay for coverage that conflicts with their faith and values.  The ruling is not the first time O’Connor has challenged the ACA – in 2018 he ruled the entire health care law to be unconstitutional, which the Supreme Court overturned in 2021.  It was not immediately clear what kind of impact the ruling will have beyond the employers challenging the ACA provision.

ICYMI: Portraits of Barack and Michelle Obama Unveiled at White House 

Former President Barack Obama and former First Lady Michelle Obama returned to the White House this week for the unveiling of their official portraits.  President Obama’s photo-realistic portrait was painted by Robert McCurdy and Michelle Obama’s portrait was painted by Sharon Sprung.  The portrait unveiling is a long tradition that goes back to 1978 when President Jimmy Carter invited his immediate predecessor, Gerald Ford, back to the White House. Wednesday’s unveiling event would have traditionally been held during the Trump presidency, although both parties mutually declined to participate according to sources.

FDA Authorizes Boosters Tailored to BA.5

On Wednesday, the Food and Drug Administration (FDA) authorized bivalent COVID-19 booster shots from Pfizer and Moderna that target both the original COVID-19 strain and the Omicron BA.4/5 subvariants.   The Centers for Disease Control and Prevention (CDC) is widely expect to sign-off on the boosters today, which means pharmacies could start administering doses after Labor Day weekend.  According to the FDA, it may take up to two months before data is available on how effective the updated boosters are at preventing infection.  So far, the federal government has secured 171 million doses from Pfizer and Moderna.

House Democrats Consider CR through December 16

According to news reports, House Democratic leaders are working on a continuing resolution (CR) that would extend current government funding levels through December 16.  The current fiscal year ends on September 30, and House Democrats are hoping to bring their CR to the House floor for consideration during the week of September 12.  While negotiations over stopgap spending bills have typically been contentious, lawmakers may be more willing to cut a deal sooner rather than later this month due to an eagerness to return to the campaign trail ahead of November’s midterm elections.   Of note, a CR could include a reauthorization of FDA user fee programs, which are also set to expire at the end of September.

CDC: Life Expectancy in US Dropped to 76 Years in 2021

Life expectancy in the US fell from 79 years in 2019 to 76.1 years in 2021, according to data from the CDC.  The decline marks the first time life expectancy dropped two consecutive years in nearly a century.  According to the CDC, the decline in life expectancy can be attributed to the COVID-19 pandemic and increases in unintentional injuries, namely drug overdoses.  While a drop in life expectancy was observed in all 50 states, the CDC found that Southern states saw the biggest declines, as well as Indiana, Missouri, New Mexico, Ohio, and Oklahoma.

HHS Issues $20M in Grants on Maternal and Infant Health

On Monday, the Biden administration took a major step in carrying out its Blueprint for Addressing the Maternal Health Crisis by announcing investments of over $20 million to improve maternal and infant health.  According to a press release from the Department of Health and Human Services (HHS), the awards include $9 million to the State Maternal Health Innovation Program, $4 million to the Rural Maternity and Obstetrics Management Strategies Program, $3 million to 19 Healthy Start programs to reduce maternal health disparities, and $4.5 million to the Catalyst for Infant Health Equity Program.

ICYMI: Fencing Around Supreme Court Removed

Metal fencing that had surrounded the Supreme Court building for the past few months finally came down earlier this week.  The fences were initially erected in May after a draft decision to overturn Roe v. Wade leaked, which prompted protests in front of the court building.  However, the building itself remains closed, and the court has yet to comment on when the building will reopen to the public.