Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, discusses Robert F. Kennedy Jr.'s potential role as HHS Secretary in President-Elect Donald Trump’s second term.
Bloomberg Health Law & Business, “RFK Jr. Fuels Uncertainty on Policies from Medicare to Abortion,” by Celine Castronuovo, Tony Pugh, and Ganny Belloni.
Following is an excerpt:
Medicare, ACA
Kennedy, if confirmed, is likely to focus mainly on issues related to science and evidence, with less attention on the Centers for Medicare & Medicaid Services, according to Richard Hughes, an attorney at Epstein Becker & Green, P.C., in Washington, D.C.
Despite previous GOP efforts to repeal and replace the Affordable Care Act, “there’s so much popularity around coverage expansions that it would be really hard to see a rollback of any of the commercial coverage requirements,” in the ACA, Hughes said. …
Trump and Kennedy could also try to overturn, repeal, or remake the IRA’s Medicare drug price negotiations that set “fair prices” for drugs provided under the program, using international reference pricing instead of direct negotiations, Hughes said. …
Medicaid
Medicaid could be in the crosshairs under Kennedy’s leadership, analysts say.
“It’s an easy target” when Congress and the administration is looking to lower costs, Hughes said. The GOP previously tried cutting Medicaid through “per capita caps,” or block grants that proved unpopular because they could increase state costs. …
Work requirements for Medicaid beneficiaries could be imposed administratively through the CMS or legislatively through Congress, Hughes said.
Modern Healthcare, “Washington Healthcare World Steels Itself for RFK Jr.’s HHS,” by Bridget Early. (Read the full version – subscription required.)
Following is an excerpt:
Medicare, Medicaid and more
After Trump nominated him with the statement that "Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation and disinformation," Kennedy signaled HHS' scientific agencies such as the Centers for Disease Control and Prevention, the National Institutes of Health, and the Food and Drug Administration would be in his crosshairs. …
None of that, however, illuminates how Kennedy would focus on the nitty gritty business of healthcare and the practices at the Centers for Medicare and Medicaid Services that are so central to much of the healthcare sector.
There are some hints from Kennedy's presidential run that not everything will be a radical departure from Trump's past policies or those of President Joe Biden.
For instance, Kennedy has talked about enforcing mental health parity laws on insurers and improving Black maternal health, which are Biden administration priorities. Kennedy has discussed aligning U.S. drug prices with lower costs in the rest of the world, similar to Trump's proposals to institute international reference pricing for pharmaceuticals.
Beyond the top-line items Kennedy emphasizes, industry sources are not convinced he would go much deeper.
Richard Hughes, a lawyer with Epstein Becker Green, is among several skeptics. "My sense is that CMS will remain on a fairly steady trajectory," he wrote in an email.
"I am doubtful that Robert F. Kennedy, Jr. will venture very much into that domain. He's far more interested in science issues over at CDC, NIH and FDA," Hughes wrote. "We are likely to see him defer to Trump's choice, and that choice is likely to be someone with a combination of extensive public and private health sector experience like Michael Burgess, Joe Grogan or Brad Smith."
Depending on your political perspective, that could be a good or bad thing.
The Hill, “Drug Industry Treads Carefully After Stunning RFK Jr. Nomination,” by Sylvan Lane.
Following is an excerpt:
The selection of Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS) sent shock waves through the pharmaceutical industry.
But many of the industry sources and outside lobbyists who spoke to The Hill said they are not prepared to outright oppose Kennedy, at least for now.
Lobbyists said they anticipated Kennedy would get some kind of role in the administration but were surprised at his being picked for HHS secretary. They are now scrambling to figure out what kind of damage Kennedy could inflict were he to be confirmed. …
Kennedy argues the rise of chronic diseases in America can be traced to ultraprocessed foods, environmental toxins and chemical additives. He wants to ban fluoridated water and increase access to raw milk.
Even before Kennedy was officially tapped to lead the nation’s top health agency, public health experts were worried that he could amplify vaccine hesitancy and direct agency funding to favor his preferred views.
Still, lobbyists said they are advising clients to let the nomination play out among Senate Republicans. They are preaching patience, as they don’t want to risk expending political capital to wind up on President-elect Trump’s bad side before he even takes office.
“A lot of companies are going to be reluctant to engage in politics,” said Richard Hughes IV, an attorney at Epstein Becker Green.
Hughes said it wasn’t necessarily a given that Trump would be friendly to the industry, but Kennedy’s confirmation would add a completely different element that could make the government outright hostile toward innovative drugs, especially vaccines.
“The way that President Trump has set it up for him, you know, he’s basically said that [Kennedy’s] going to have carte blanche. So, will he check himself? Will members of President Trump’s party in Congress check him?” Hughes said.
Clinical Trials Arena, “Worldwide 2024 Elections Pose Pivotal Shifts in Life Sciences and Healthcare,” by Frankie Fattorini.
Following is an excerpt:
The outcomes of this year’s US, EU, and UK elections and their downstream effects will lead to drastic changes to international healthcare and life sciences sectors, said analysts gathered at a recent industry event.
The US President-elect Trump’s approach to regulation, centralised life sciences funding in the EU, and the UK Labour government’s 10-year plan were at the top of the agenda for analysts looking at the life sciences sector with their outlook ranging from concern to cautious optimism. The discussion took place at the Jefferies London Healthcare Conference on 21 November.
Taxes and tariffs imposed by the incoming Trump administration were seen as major points of interest by Citseko Staples Miller, managing director at FTI Consulting. These decisions, she said, could affect healthcare companies based outside of the US, as an ‘America first’ stance on tariffs may restrict accessibility to pharmaceuticals imported to the US market.
These concerns were echoed by Richard Hughes, partner at Epstein, Becker & Green. According to Hughes, Trump may seek to revitalise attempts at repealing the Inflation Reduction Act, seen as President Biden’s signature achievement, or otherwise “put his imprint” on drug price negotiations.
Hughes emphasised worries around Robert F. Kennedy Jr.’s nomination as Health Secretary. He noted the “tremendous sway” Kennedy could hold over organisations such as the CDC (Centers for Disease Control) and FDA (Food and Drug Administration). In light of Kennedy’s outspoken anti-vaccine position, Hughes said he might seek to restructure or even dismantle these regulatory bodies.
Education Week, “What Could RFK Jr. as HHS Secretary Mean for School Vaccine Requirements?” by Matthew Stone.
Following is an excerpt:
A Health and Human Services Department under vaccine skeptic Robert F. Kennedy Jr. could pull several different levers that result in weakened school vaccination requirements, even though those are set by states. …
Schools have a long tradition of conditioning admission on immunizations
Schools have a long tradition as a lynchpin in America’s public health infrastructure. The first schools to require that incoming students be vaccinated did so in the 1850s to prevent the spread of smallpox, according to the Mayo Clinic.
The Supreme Court upheld such requirements in a 1922 case, Zucht v. King, in which an unvaccinated student challenged a school vaccination rule in San Antonio, Texas.
Today, all 50 states require that children entering child care, pre-kindergarten, and K-12 schools be immunized against polio; chickenpox; measles, mumps, and rubella; and diptheria, tetanus, and pertussis (whooping cough), according to the Immunization Action Coalition. Some have requirements for vaccinations against Hepatitis A and B, influenza, and human papillomavirus.
In addition to playing a key role in infectious disease prevention, schools in recent decades have also taken on a bigger role in preventing chronic diseases such as obesity. Many have removed soft drinks from vending machines and now routinely measure students’ body mass index, said Richard Hughes IV, a lecturer at the George Washington University School of Law and a health lawyer.
“RFK Jr., his whole philosophy about public health is that we need to focus more on chronic disease and less on infectious disease, and that doesn’t really square with the principles of public health,” said Hughes, who is also a former public policy director for the vaccine developer Moderna and previously served on the Arkansas State Board of Health as an appointee of former Republican Gov. Mike Huckabee. “Over the last few decades, public health is increasingly focused on chronic disease, but not at the expense of infectious disease.”
While vaccination requirements have long been the purview of individual states, there are provisions of federal law the Trump administration could use to influence vaccine policy in its desired direction, Hughes said.
The CDC has authority under the Public Health Services Act, a 1944 law, to “control communicable diseases,” and the law also has a clause allowing the federal government to preempt any state law that “conflicts with an exercise of federal authority under this section.”
“It’s really more of a question than a definitive answer as to whether the federal government could just simply set its own vaccine policies and force the states to comply with those,” Hughes said.
Such a move would likely prompt litigation over the delineation of state and federal authority, he said.
Short of using that direct mechanism, the federal government has leverage to influence state vaccine policies through the grant funding it distributes to build up state and local immunization programs.
Under the section of the law that authorizes those grants, Hughes said, “CDC has wide latitude in how it gives out that money and the conditions that it sets.” That language raises the specter of new conditions that might involve the adoption of revised vaccine schedules or broadened exemptions from vaccine requirements.
The Washington Post, “The Playbook RFK Jr. Could Use to Restrict Vaccine Access,” by Leana S. Wen. (Read the full version – subscription required.)
Following is an excerpt:
The most insidious method for Kennedy to undermine vaccines would be a takeover of the CDC’s Advisory Committee on Immunization Practices (ACIP), which develops recommendations for how vaccines are used. By replacing existing ACIP members with vaccine skeptics, he could say he’s not interfering with the CDC, but rather that “experts” have decided vaccines aren’t safe.
ACIP wouldn’t even have to recommend against a vaccine to have an impact. As Richard H. Hughes, a lawyer and vaccine policy researcher, explained to me, a non-recommendation affects insurance coverage. Under the Affordable Care Act, insurance plans are obligated to cover ACIP-recommended vaccines. If ACIP pulls the coronavirus shot from its recommended list, people might suddenly find themselves charged hundreds of dollars to be vaccinated.
Axios, “How RFK Jr. Could Use Levers of HHS to Shape Vaccine and Drug Outcomes,” by Adriel Bettelheim and Tina Reed. (Read the full version – subscription required.)
Following is an excerpt:
What to watch: There's a question about whether HHS could usurp school vaccine requirements using section 361 of the Public Health Service Act of 1944, which gives it the authority to "control communicable diseases."
"The answer is not entirely straightforward and would set off legal challenges," Richard Hughes of Epstein Becker Green wrote.
STAT News, “How RFK Jr. Could Strip Legal Protections from Vaccine Makers as HHS Secretary,” by Rachel Cohrs Zhang. (Read the full version – subscription required.)
