Happy Monday! There are only a few in-session days for Congress until August Recess. So, the pressure is on for lawmakers to finalize spending bills and other critical legislative packages. Here is what you need to know going into the week.

In this week’s Nimitz Health:

• Federal News: Congress edges closer to a shutdown over health agency cuts, Democrats push insurers to preserve vaccine coverage, and CMS looks to raise outpatient Medicare payments.

• State News: Florida's top health official reignites vaccine injury debate, and more states adopt CMS’s gene therapy program for sickle cell treatment.

• Industry News: Trump says Coke will ditch corn syrup, gene therapy halted after patient deaths, and FDA green-lights Juul sales.

WHO’S HAVING EVENTS THIS WEEK?

Tuesday, July 22nd

• *House Energy & Commerce: “Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System” at 10:15am. Watch here.

• Senate Finance: “Hearings to examine the nomination of Alex Adams to be Assistant Secretary for Family Support at HHS” at 10:15am. Watch here.

• *House Ways & Means: “Medicare Advantage: Past Lessons, Present Insights, Future Opportunities” at 2pm. Watch here.

Thursday, July 24th

• Senate HELP: “Business meeting to consider the nomination of Brian Christine to be an Assistant Secretary of Health and Human Services” at a time to be announced. Watch here.

*Will be covered by Nimitz Health. Please email [email protected] if you would like a readout of any other hearings.

NEWS DRIVING THE WEEK

Federal News

Congress is staring down another fiscal standoff as Senate Republicans move to bring four spending bills to the floor this week to avert a government shutdown down the line. The push revives negotiations on funding for agencies like HHS and FDA, which face cuts under President Trump’s proposed budget. Democrats and the Congressional Budget Office are sounding alarms over the implications for drug development and biomedical research, citing warnings that NIH and FDA reductions could delay clinical trials and slow regulatory timelines

Last Wednesday, President Trump signed the HALT Fentanyl Act into law, permanently scheduling all fentanyl analogues as Schedule I substances. The law imposes a 10-year mandatory minimum for trafficking and expands federal authority to prosecute synthetic opioid crimes. The legislation, which passed with some bipartisan support, is being framed by the White House as a major win in the fight against Mexican cartels and Chinese chemical exporters.

Meanwhile, Democratic leaders are pressing insurers to maintain full coverage for CDC-recommended vaccines, including Covid-19 and RSV shots, amid concerns that HHS under Secretary Robert F. Kennedy Jr. is weakening federal vaccine policy. In a letter last week, House Democrats warned that such moves would violate ACA coverage guarantees and reverse progress in immunization rates.

CMS unveiled a proposal to raise outpatient Medicare payments by 2.4%, injecting $8 billion into the system, while advancing site-neutral payment reforms. Hospital groups are pushing back hard on provisions that reduce payments to off-campus departments and speed up the timeline to recoup $7.8 billion in 340B drug discount overpayments. New transparency mandates would also require hospitals to publish median and percentile reimbursement rates.

State News

Florida Surgeon General Joseph Ladapo is urging NIH to invest more in research on adverse reactions to Covid-19 vaccines. Citing anecdotal patient experiences and aligning with HHS Secretary Kennedy’s vaccine-skeptical posture, Ladapo claims the risks of mRNA vaccines remain under-examined and underreported. He’s asking NIH to shift research priorities toward long-term safety and treatment of post-vaccination syndromes.

Meanwhile, 33 states, plus D.C. and Puerto Rico, have signed on to CMS’s Cell and Gene Therapy Access Model to support coverage of high-cost sickle cell therapies like Casgevy and Lyfgenia. The federal program allows states to negotiate outcome-based payment deals, includes support for fertility preservation and travel, and aims to reduce financial risk while expanding access for Medicaid patients.

Industry News

Last week, President Trump declared that Coca-Cola plans to replace high-fructose corn syrup (HFCS) with cane sugar in its U.S. production. While Coca-Cola has not confirmed the change, the statement immediately stirred backlash from the Corn Refiners Association, which accused the administration of waging a “covert regulatory war” on corn sweeteners. While most experts agree sucrose and HFCS have the same nutritional value, multiple studies link HFCS consumption to increased risk of obesity, type 2 diabetes, and metabolic syndrome when compared to sucrose (cane sugar). This is due in part to how the body processes fructose differently, leading to reduced satiety and greater fat storage.

Meanwhile, the FDA has placed a full clinical hold on Sarepta’s Elevidys gene therapy and related trials after three patient deaths. The agency has halted commercial distribution and is requiring Sarepta to submit detailed safety data. The move is a major regulatory setback for the field of systemic gene therapy, which had been gaining traction after early approvals.

Also on the FDA front, GSK’s efforts to bring Blenrep, its blood cancer drug, back to market were blocked after an FDA advisory panel declined to endorse its efficacy. The rejection underlines the agency’s harder line on accelerated approvals, particularly in oncology, where past tolerance for limited data is narrowing.

Finally, the FDA also granted market authorization for select Juul products, reversing its 2022 ban and allowing tobacco-flavored pods to return to retail shelves. Regulators justified the decision on harm-reduction grounds for adult smokers, though anti-tobacco advocates warned it risks reigniting youth vaping.

FOR FUN

If you want to follow Congress’s lead and take an August hiatus, check out this article for the newest direct flights out of DMV airports. Highlights include Nice, Venice, Palm Springs, Seattle, and more.

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