This Week in Congress

House and Senate

The House and Senate were out of session this week and will return on February 27.

Federal Debt Limit

Congress must raise the US federal debt ceiling by the summer or early fall in order to avoid the risk of a federal payment default. The date represents the moment when the Treasury Department will have exhausted the special accounting maneuvers to avoid breaching the debt limit. Treasury Secretary Yellen advised Congress last month, when the $31.4 trillion limit was hit, that date would come sometime after the start of June. Without congressional action, the Treasury no longer be able meet all US payment obligations, including to bondholders, federal employees, contractors, Social Security and other entitlement beneficiaries.

Other Legislative Happenings from Around the Nation

Transgender Divide

Lawmakers in 27 states are currently debating legislation with the goal of restricting or banning access to gender affirming medical care for transgender youth. Gender affirming care encompasses a range of social, psychological, behavioral, and medical interventions to support a person’s gender identity. These interventions can include social changes, hormone-related treatments that delay puberty or promote development of masculine or feminine sex characteristics, and in some cases can include surgical interventions. The bills, which impose civil or criminal penalties on parents and medical professionals that provide gender affirming care to minors, or outlaw any public funding that facilitates gender affirming treatments, are being aggressively challenged in the courts by LGBTQ advocacy groups.

Doxycycline

Clinical Trial

A clinical trial in Kenya found that taking the antibiotic doxycycline after sex did not prevent sexually transmitted infections (STIs) in cisgender women, researchers reported at this week’s Conference on Retroviruses and Opportunistic Infections. The article can be found here

Experts Call on CDC to Endorse Preventive Antibiotics

As the US struggles with the STD crisis, public health experts are calling on the CDC to endorse prescribing preventive antibiotics to gay and bisexual men and transgender women who are at high risk of STDs. But while a growing body of research shows that taking doxycycline after sex substantially lowers STD infection rates in this population, some experts remain concerned that widespread use of the antibiotic for this purpose could do more harm than good by fueling the global crisis of antibiotic-resistant infections and harming people’s microbiomes.

David Harvey

Mr. Harvey, Executive Director of the National Coalition of STD Directors, said “the overall infection surge is driven, in part, by federal cuts to state STD programs.” Harvey, like many other public health experts, is looking to doxycycline, which typically costs pennies per pill, as a potent tool that could help turn the STD tide. The article can be found here

340B

America’s Essential Hospitals is putting pressure on HHS to repay hospitals for Part B 340B drug pay cuts from 2018 through 2022.  AEH stated that CMS should not try to use a new acquisition cost survey to justify those past cuts, nor should it look to recoup funds from some hospitals as it repays others. The U.S. District Court for DC gave HHS the opportunity to develop a plan to repay 340B hospitals for years’ worth of drug pay cuts in light of the Supreme Court’s decision that those cuts were unconstitutional. The American Hospital Association had warned that any attempt by CMS to prospectively repay hospitals or to claw back funds from hospitals as it repays the 340B participants could lead to more lawsuits. AHA contends CMS should promptly repay the hospitals the difference between what 340B hospitals were paid for 340B drugs from 2018 through 2022 and pay rate that other hospitals received for Part B drugs, plus interest. The group adds that under no circumstances should CMS put forward a new survey of acquisition costs to justify its past cuts.

Mpox

Deaths from Mpox in Immune Compromised

Mpox can have a devastating impact on people with advanced cases of HIV, leading to severe skin and genital lesions and causing death in as many as 1 in 4 of those with a highly compromised immune system. This is the first major study of mpox in this population, which a global team of authors published in The Lancet. The analysis included 382 people from 28 nations, all of whom were HIV-positive and had a low count of key immune cells, which help ward off infections. Twenty-seven of these individuals died.

CDC Recommends Jynneos Vaccine

Advisers to the CDC voted in favor of using Bavarian Nordic’s Jynneos vaccine for all adults at risk of mpox during an outbreak. The panel of outside experts voted unanimously in favor of the use of two doses of the vaccine, and finalizing the interim guidelines provided by CDC during the mpox outbreak in the US. The recommendation of the committee is based on studies that showed vaccine effectiveness of 66%-83% for patients with full vaccination and 36%-86% for partial vaccination.  No severe adverse effect were found.  The article can be found here.

Abortion

This week a dozen states sued the FDA and the Department of HHS alleging the federal government is hampering access to a common drug used to induce abortions and endangering patients and providers. The lawsuit, led by Washington Attorney General Ferguson, says the FDA has singled out mifepristone “for a unique set of restrictions” known as a Risk Evaluation and Mitigation Strategy. The restrictions on mifepristone strictly limit who can prescribe and dispense the drug. “This case is about whether it is improper and discriminatory for FDA to relegate mifepristone—a medication that has been used over 5 million times with very low rates of complications, very high rates of efficacy, and which is critical to the reproductive rights of the Plaintiff States’ residents, as well as visitors who travel to the Plaintiff States to seek abortion care. The FDA’s decision to continue its “burdensome restrictions” has “no basis in science,” the lawsuit said. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.” The states seek a court order directing the FDA to “follow the science and the law” and remove the restrictions on a “proven drug that is a core element of reproductive health care.” Washington is joined by Oregon; Arizona; Colorado; Connecticut; Delaware; Illinois; Michigan; Nevada; New Mexico; Rhode Island; and Vermont. The states collectively represent more than 59 million Americans with protected rights to abortion care, the filing said.

Ohio

An effort to place a constitutional amendment protecting abortion rights on the ballot is growing in Ohio. Ohioans for Reproductive Freedom and Ohio Physicians for Reproductive Rights filed paperwork with the state’s attorney general to try to protect abortion rights in the state constitution.

Texas

A Texas federal judge refused to set an accelerated trial schedule for a lawsuit by anti-abortion groups seeking to end U.S. sales of the abortion pill mifepristone, in a case that could severely disrupt access to medication abortion nationwide.

Montana

A state lawmaker who is an ordained Jewish rabbi argues religious freedom laws that protect health care workers’ religious beliefs should also protect abortion rights for those who belong to religions that support such rights. “It seems that both sides should be permitted to have equal protections for their religious conscience,” said Rep. Stafman.