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It’s the last week of legislative activity in DC before August recess, but around the rest of the country, political activity is starting to heat up. And this year it’s a political heatwave as Vice President Kamala Harris has quickly moved to consolidate her position as the presumptive Democratic nominee with strong fundraising numbers and key endorsements, including from the Obamas. As an Iowan, your author cannot help but wonder if Harris will make a trip to the Iowa State Fair with its famous butter cow to build on her momentum (maybe with her running mate)? So, with that shameless plug for my home state out of the way, let’s get into it. Welcome to the Week Ahead!
The Administration
A public official with years of experience has decided to step aside and let someone else take the reins. No, we aren’t talking about Joe Biden. We are talking about the Director of the Food and Drug Administration’s (FDA’S) Center for Devices and Radiological Health (CDRH), Dr. Jeff Shuren. As of July 28, Dr. Michelle Tarver, who previously served as the Center’s acting deputy director, has taken over the top job. Dr. Shuren will be staying with the agency through the end of 2024 to help with the transition.
So what? While it’s understandable that the retirement of an FDA official wouldn’t make news in the same way as a sitting President deciding not to seek re-election, the question of what Dr. Shuren does next could have major implications for health care policy and the health care industry. If Vice-President Harris is successful in her White House bid, will Dr. Shuren throw his hat in the ring for a job with the new Administration such as FDA Commissioner? If he doesn’t return to government service, will Dr. Shuren decide to join the board of a medical devices company or other organization? You can be sure we will be watching to see where Dr. Shuren ends up.
The Senate
Are We There Yet?
Like many kids in the backseats of countless minivans this summer, many senators must be asking this question: are we there yet – may we start recess. But these senators are probably not eager to get to Disney World, they want to get back to the campaign trail (either for themselves or their party’s presidential nominee).
The big thing keeping the Senate in town is the decision by Senate appropriators to schedule an August 1 markup of five Fiscal Year 2025 funding bills, including for the Department of Health and Human Services. If the Committee can get these bills passed, they will have marked up every appropriations bill ahead of August recess.
Senate Health Hearings
- July 31: Senate Health, Education, Labor, and Pensions Committee Executive Session to consider the Older Americans Act Reauthorization Act, the Autism CARES Act, and the Traumatic Brain Injury Program Reauthorization Act
- July 31: Senate Judiciary Human Rights and the Law Subcommittee hearing on giving birth behind bars
The House
Like many folks right before a trip, the House decided some things could wait, having ducked out for the August work period on July 25. When they come back, they will have to come to an agreement on how to fund the government and continuing conversations on how to address upcoming deadlines such as when the current Medicare telehealth flexibilities expire.
The House did manage to pass one thing before leaving town: A resolution condemning Vice President Harris for her role as “border czar” in the current Administration. That will give members on both sides of the aisle plenty of fodder for the campaign trail.
There You Have It
Things tend to quiet down in Washington during August, and we will be taking a break from the Week Ahead until Congress returns on September 9. In the meantime, we encourage you to check out our firm’s LinkedIn page, where we will be sharing our summer reading recommendations throughout August. Make it a great week, and a great month, we will see you in September!
The last couple of weeks have been chaotic to say the least with the attempted assassination of former President Trump and President Biden announcing he will not run for reelection. All this comes as Congress prepares to hear from Israeli Prime Minister Benjamin Netanyahu and start the mad dash to August recess. So, let’s get into it. Welcome to the Week Ahead!
The Administration
President Biden became the first President since LBJ to announce on July 21st, that he would not seek a second term as President of the United States. This raises a whole host of questions. Here is what we know and what we don’t yet know about this historic decision.
What we know:
- President Biden has endorsed Vice-President Harris to be the Democratic nominee for President
- Prominent Democrats, including the Clintons, Rep. Jim Clyburn, the campaign arm of the Congressional Black Caucus (CBC) and Congressional Progressive Caucus Chair, Rep. Jayapal (D-WA), have also endorsed Harris
- At this point, the Democratic National Committee is planning on moving ahead with the plan to formally nominate their candidate by virtual roll call in the first week of August
What we don’t know yet:
- What will the Democratic National Convention look like? Open Convention? Brokered convention?
- Will anyone challenge Harris?
- Who will be the Democratic Vice-Presidential nominee?
President Biden not seeking a second term also raises questions about what the rest of his term will look like. The President is determined to serve through the end of his term, but prominent Republicans are already calling for President Biden to resign effective immediately. We’ve heard rumors that efforts to get President Biden’s cabinet to invoke the 25th Amendment may see a new lease on life following Biden’s announcement.
President Biden’s remaining months in office may be spent trying to cement his legacy. Something that could make that more challenging is the recent repeal of Chevron Deference Doctrine by the Supreme Court, which ended the long-held practice of giving deference to federal agencies when the laws they are tasked with implementing are not clear. How the Biden Administration navigates in this new post-Chevron era will impact the likelihood that notable health care rules, including a nursing home staffing mandate and one that would regulate lab-developed tests as medical devices, survive legal challenges.
The Senate
Waiting on Appropriations
The big question in the Senate: what is the timeline for marking up the remaining appropriations bills? On July 11, the committee approved the :Legislative Branch, Ag-FDA, and the Military Construction-VA bills unanimously. On July 25, the Committee is scheduled to markup the Commerce-Justice-Science, State and Foreign Operations, and Transportation-House and Urban Development bills.
What about the rest? If the Appropriations Committee advances the three bills they are scheduled to markup on July 25, that still leaves 6 remaining appropriations bills, including the one for Labor-HHS. Will the Senate Appropriations Committee continue its record of bipartisanship, or will it get caught up by partisan disagreements or political gamesmanship?
Senate Health Care Hearings This Week
- July 24: Senate Homeland Security and Governmental Affairs Committee hearing to consider S. 4667, the Risky Research Review Act, S. 4697, the Healthcare Cybersecurity Act of 2024, and H.R. 3254, the First Responder Access to Innovative Technologies Act
- July 25: Senate HELP Committee hearing to authorize an investigation into the bankruptcy of Steward Health and subpoena Chairman and CEO Dr. Ralph de la Torre
The House
Health Care Week on Hold?
Recent talk about a “Health Care Week” in the House where several health care bills would be considered may be put on hold because of the attempted assassination of former President Trump. Conversations we are having on the Hill seem to suggest that the assassination attempt has sucked the oxygen out of the room needed to talk about anything else. It seems likely that any remaining oxygen left this week will focus on the news of Biden’s dropping out of the race and what the new Democratic ticket will look like.
So what? There are only two legislative weeks left before August recess. After that, election season will be in full swing, and before you know it, we are eating turkey and singing Christmas carols. The time is especially short for House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) who is a champion of many of the bills that might be considered during a “Health Week” and one of the members who is retiring from Congress.
Appropriations Woes
The House also must fit appropriations into the already tight schedule, and the recent failure of the House to pass its appropriations bill for the Legislative Branch (usually a light lift) signals there may be trouble ahead. Given these difficulties, it seems likely that the House will need to consider a short-term continuing resolution to keep the government funded from October through the election. That doesn’t mean House leadership is giving up on passing appropriations legislation. On July 22, the House Rules Committee is scheduled to meet to consider four appropriations bills (Financial Services and General Government, Interior and the Environment, Energy and Water, and Agriculture and FDA.
One more thing: Even if any of the House appropriations bills are DOA in the Democratic Senate, these bills still serve as important markers for what members care about.
House Health Care Hearings
- July 22: House VA Subcommittee on Technology Modernization hearing on Assessing Electronic Health Records Modernization
- July 23: House Oversight Committee hearing on PBMs
- July 23: House Energy and Commerce Health Subcommittee hearing on the CDC
- July 24: House Natural Resources Subcommittee on Indian and Insular Affairs Legislative hearing, including legislation related to IHS
There You Have It
Did you watch the RNC? If you did, you may have gotten a free Kid Rock performance. That was just one thing that made the final night unique, even though Kid Rock has been a mainstay of previous Republican Conventions. Now we look ahead to the DNC which is set to be interesting for a whole different set of reasons. Make it a great week!
On June 28th, the Supreme Court ruled to overturn the “Chevron” deference doctrine (in Loper Bright Enterprises v. Raimondo). The 1984 Chevron defense directs the nation’s courts to defer to a government agency’s interpretation of statute under circumstances where the law was vaguely written. The June 28th ruling shifts the deference away from the executive branch to the judicial branch when congressional intent is implicit.
Analysts and legal scholars agree that this will have dramatic consequences for health care, calling into question government rules on everything from nursing home care to clinical lab regulation to coverage mandates under the Affordable Care Act (ACA).
Why will this shift affect so many aspects of health care? First, federal laws are often written vaguely to provide agencies flexibility to implement the changes as needed. That vagueness allows technical and scientific experts to make real-world policy decisions on how to implement what Congress passes. So, 50+ years of healthcare policy in action is now open to challenge, re-writing, and nullification.
Second, the ruling will unleash a torrent of litigation. One friend of the court brief filed by the American Cancer Society and other organizations stated that this ruling would open a “litigation tsunami” on even long-settled healthcare policy. This could leave regulation with even more holes depending on rulings in different local, state, and federal courts – causing providers, insurers, and other healthcare players to struggle with compliance.
Third, the ruling could lead to more uncertainty and less stability for players in the healthcare system. For example, even simple things like the government deciding what to pay hospitals or physicians could be subject to long legal battles that could disrupt payments and patient care.
Lastly, this could significantly delay any enactment of new policies by the agencies and Congress. For example, scholars are pointing out that the FDA is extremely risk adverse and this ruling could significantly delay the release of new drugs and treatments. Congressional experts are also warning that this could slow the Congressional draft/legislating process even more as Congress would have to take more time drafting their legislative language to avoid future legal challenges. This could also pose a significant threat to those issues that need faster rulings – like supplemental appropriations (e.g., funding for things like the war in Ukraine) or regulations surrounding use of Artificial Intelligence (AI).
We will continue to watch as things unfold, but it is extremely likely that new lawsuits will be filed to stop the nursing home staffing rule, the LDT lab rule, and price negotiations for Medicare drugs.
The fireworks are just starting in Washington, DC even if Independence Day celebration is over. Democratic offices on the Hill are still working out the best way to handle President Biden’s debate performance, his subsequent interview with ABC, and questions about his fitness for office. Additionally, there is a new framework on how to implement federal regulations with the repeal of the Chevron Deference doctrine. So don’t put away those lawn chairs and blankets just yet. Welcome to the Week Ahead!
The Administration
We are eagerly waiting for the release of the CY 2025 proposed rules for the Physician Fee Schedule and the Outpatient Prospective Payment System. While we expected them last week, don’t worry the rules aren’t late – they dropped mid-July last year.
The Centers for Medicare and Medicaid Services (CMS) did drop the CY 2025 Home Health Proposed Rule and the CY 2025 End Stage Renal Disease (ESRD) Proposed Rule on June 26 and June 27, respectively. The proposed home health rule included an overall rate reduction of -1.7%. The proposed ESRD rule increases the base rate to $273.20.
Don’t forget – the FY 2025 final rules for inpatient hospitals, skilled nursing facilities, and inpatient rehabilitation facilities are coming out soon. They are under review at OMB right now.
But what about Chevron? The repeal of the Chevron Deference Doctrine by the Supreme Court on June 28 ends the long-held practice of giving deference to federal agencies when the laws they are tasked with implementing are not clear. This decision could complicate finalizing all sorts of rules, including health care provider payment rules. The Administration condemned the decision as one that will “block common-sense rules that keep us safe, protect our health and environment, safeguard our financial system, and support American consumers and workers.” Leading Democratic members of Congress, including Senate Majority Leader Schumer and House Judiciary Committee Ranking Member Nadler, have also criticized the decision.
The Senate
Nursing Home Staffing Rule Rebuke Possible
Speaking of rules, we are hearing rumors from within the Senate Democratic caucus that a Congressional Review Act vote may occur on the Biden Administration’s rule that would create a nursing home staffing mandate. This rule has come under fire from nursing homes and hospitals, and drawn bipartisan criticism on the Hill, especially in rural districts.
Although many Democratic senators are expected to vote against repealing the mandate, Democratic leadership may be looking to give a pass to vulnerable senators who face tough re-election campaigns in November. We expect the measure to pass in the Senate to pass this measure and to eventually make its way to President Biden’s desk where we expect he will veto the bill. We don’t see a scenario in which there is enough Democratic support to overturn the veto.
Health Care Hearings to Watch
- July 9: Senate Health, Education, Labor, and Pensions Subcommittee on Children and Families hearing on the impact of high costs (not explicitly health care, but health care costs are certainly a concern members like to talk about)
- July 11: Senate HELP Committee hearing on medical debt
- July 11: Senate Special Committee on Aging hearing on health care transparency
- July 11: Senate Appropriations Markup of Milcon-VA, Ag-FDA, and Legislative Branch Appropriations Acts and FY25 Subcommittee Allocations
- July 11: Senate Homeland Security and Governmental Affairs Committee hearing on Oversight of Taxpayer-Funded High-Risk Virus Research
The House
Biden’s House Woes
More Democratic Representatives are calling for President Biden to step aside and let someone else face former President Trump in the 2024 election as the House returns from recess. So far, that list includes Reps. Craig, Quigley, Kuster (Nem Democat Coalition Chair), Moulton, Doggett, and Grijalva. The New York Times is also reporting that Reps. Nadler, Adam Smith, Takano, and Morelle have urged House Minority Leader Jeffries to get President Biden to end his reelection bid. These House Democrats join the Democratic Governor of Massachusetts in calling for Biden to let someone else run. Additionally, Sen. Warner of Virginia is reportedly working on building support among Senate Democrats to urge Biden to get out of the race.
Labor-HHS and FDA Appropriations Bills Set to be Marked Up
The House Appropriations Committee is scheduled to markup the Labor, Health and Human Services (HHS), Education, and Related Agencies Appropriations Bill for FY 2025 on July 10. It is also scheduled to markup other appropriation legislation, including its version of the Agriculture, Rural Development, Food and Drug Administration (FDA) Appropriations Bill for FY 2025. We will be watching for details on these bills as we move closer to the markup date, and to see if the bills that emerge include any controversial provisions on hot button issues like abortion.
Ways and Means Goes West
Much like the prospectors who went west during the California gold rush, the House Ways and Means Committee will be heading west for a field hearing in Utah on July 12. But unlike those prospectors looking for gold and silver, the Committee is looking for a different type of treasure. That is how to support medical innovation.
In theory, this is an area that could be a gold mine for bipartisan action. However, it remains to be seen if the committee can strike it rich or if things will be held up by partisan disagreements over how to best get the gold. We expect Republican members to criticize government interference in private-sector innovation, while Democratic members will likely highlight the importance of investing in research to make such innovations possible and the need to ensure those innovations are affordable.
There You Have It
Can you believe it’s already July? As if that was not hard enough to believe, the Republican National Convention begins July 15! Before you know it, summer will end, and the final push to the election will be upon us. So, soak up the sun and the speeches while you can. Make it a great week!
