Insights

Congress is returning to town, with a deadline fast approaching to fund the government past September 30. The word is that Speaker Mike Johnson (R-LA) is planning on bringing up a continuing resolution (CR) that would provide level funding for the government. But Senate Majority Leader Chuck Schumer (D-NY) and Appropriations Chair Patty Murray (D-WA) issued a joint statement on September 6 calling the bill highly partisan and pre-blaming House Republicans of a potential government shutdown.  With that, let’s get into it. Welcome to the Week Ahead!  

The Administration 

Harris and Trump Prepare for Big Debate 

Vice President Harris and former President Trump will face off for the first time on a debate stage on September 10  in Philadelphia. There is a lot to watch for, but we will especially be on the look out to see how the candidates try to position themselves on health care issues. Specifically, will Vice–President Harris be asked to explain her current position on Medicare for All? Will former President Trump be asked if he still wants to repeal the ACA? We will tune in to find out! 

Season of Rules 

The Centers for Medicare and Medicaid Services (CMS) will close the comment period on two proposed rules this week: the Calendar Year 2025 (CY2025) Physician Fee Schedule proposed rule and the CY2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. We are also expecting HHS to issue a rule to expand coverage mandates for certain types of health plans to provide mental health and substance abuse coverage. 

So What? We will be watching to see how CMS resolves concerns raised about the more controversial parts of the proposed rules. For example, the American Medical Association has been very upset about the proposed reimbursement cuts in the proposed physician fee schedule rule. However, these cuts are Congressionally mandated so there is not much the agency can do. We expect more anger from the AMA if the proposed cuts are finalized.  

The Senate 

HELP Hearing Drama 

The Senate Health, Education, Labor, and Pensions (HELP) Committee is scheduled to have a hearing on September 12 to examine the bankruptcy of Steward Health Care and the impact that management decisions had on patient care. Chairman Bernie Sanders (I-VA) issued a press release Friday announcing the committee will still move forward with the hearing despite Steward CEO Ralph de la Torre’s refusal to testify.   

Dr. de la Torre is refusing to testify, despite a bipartisan subpoena issued by the committee in July. Dr. de la Torre had reportedly requested delaying his testimony until after federal investigations into fraud and corruption allegations were complete but HELP Chair Sanders was not interested in delaying committee action in the wake of what he calls an “outrageous display of corporate greed” that put “patients and communities at risk.” We will be monitoring how the Committee proceeds in the wake of Dr. de la Torre’s decision not to testify.  

Wanted: A New Member for Senate Finance  

After former Sen. Menendez (D-NJ) announced he would be stepping down in light of bribery charges, the Senate Finance Committee was left a member short. This matters because the Committee now has an equal number of Republican and Democratic Senators, which makes it hard for the majority to move legislation unless they have support from at least one member of the minority.  

So, what is to be done? Democratic New Jersey Governor Phil Murphy appointed George Samir Helmy to serve as a U.S. Senator on August 18 until the winner of the November election is determined. To keep things simple, Helmy might be given the opportunity to serve on the Finance Committee until the November elections.  

The House 

BIOSECURE Act on Deck 

House leadership looking to advance biosecurity legislation targeting Chinese biotechnology firms, has placed the BIOSECURE Act (H.R. 8333) on a list of items that could be considered the week of September 9. This bipartisan bill would prohibit federal agencies from awarding contracts, loans, or grants to biotech companies owned by foreign adversaries. The bill would apply the ban to five specific companies of concern and require the publication of a list on an annual basis. The bipartisan bill, which would have major implications for the global biotech industry, has the support of BIO and is expected to pass by suspension. 

Looking ahead for Ways and Means… and Energy and Commerce 

The Ways and Means Committee is planning to get back into the swing of things with health care activity later in September. The committee is likely to hold a hearing on special needs plans (SNPs) focusing on coordination of care and the cost of chronic care. In addition, word is that the committee will also meet to mark-up various bills, including some health priorities, later this month. 

We also are still expecting the Energy and Commerce Committee to announce a mark-up of multiple health bills, including an extension of telehealth flexibilities, later this month.   

Other Health Care Hearings 

• September 10: House Oversight and Accountability Subcommittee on Government Operations and the Federal Workforce hearing on improper payments and fraud in pandemic programs  

• September 10: House Energy and Commerce Health Subcommittee legislative hearing on FDA food and tobacco product regulation 

• September 10: House Education and Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing on employer-sponsored health benefits 

• September 10: House Select Subcommittee on the Coronavirus Pandemic hearing with former NY Governor Cuomo 

• September 10: House Veterans’ Affairs Subcommittee on Economic Opportunity Oversight hearing on evaluating mental health support programs for separating servicemembers 

• September 11: House Veterans’ Affairs Health Subcommittee legislative hearing 

• September 11:  House Energy and Commerce Subcommittee on Oversight and Investigations hearing on the organ procurement and transplantation network 

• September 11: House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust hearing on PBMs 

• September 11: House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration and House Agriculture Subcommittee on Nutrition, Foreign Agriculture, and Horticulture oversight hearing on food distribution shortages in tribal and elderly communities. 

There You Have It 

Are you planning on watching the presidential debate? Do you play Debate Bingo?  How many health care priorities are on your card? Let us know! Make it a great week!  

Even though Congress hasn’t returned to town, we are resuming the Week Ahead with a preview of what we will be watching for this month. And while we don’t have predictions on who will win the NFL season opener between the Chiefs and the Ravens, we do have plenty to say about what we expect to see in Washington. So, with that, let’s get into it. Welcome (back) to the Week Ahead!  

The Administration 

Biden-Harris Not Slowing Down on ACA Spending 

With record levels of enrollment in plans provided by the Affordable Care Act (ACA), President Biden continues to invest in his legacy to expand insurance coverage.  On August 26, 2024, the Centers for Medicare and Medicaid Services awarded $100M to organizations to help those in underserved communities sign up for coverage.  

Steps like funding for organizations to help keep ACA enrollment up in underserved communities are certainly going to be ways that the Harris-Walz ticket will try to distinguish itself from the Trump-Vance ticket. More U.S. adults hold a favorable view of the ACA than an unfavorable one, according to the latest polling by the Kaiser Family Foundation. How former President Trump, Sen. Vance, and the Congressional Republicans talk about the ACA continues to be a tricky matter as  they look to win back the White House and Senate and maintain control of the House of Representatives.  

FDA Authorizes Updated Novavax Shot 

On August 30, 2024, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to an updated version of the Novavax COVID-19 vaccine. According to the agency, this vaccine better targets variants of the virus currently circulating across the country. The updated vaccine is authorized for individuals 12 years of age and older.  

This news comes as the United States is experiencing a surge in COVID-19 cases driven by the KP.3.1.1 variant. As summer turns into fall and winter, we expect agencies like the FDA, such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), to continue to make headlines with stories about their work to stay ahead of new variants of the disease. These variants might drive even worse surges in months when more Americans spend more time indoors.  

The Senate  

Only one health care hearing is currently scheduled for September, but it’s a big one.  Novo Nordisk’s global CEO, Lars Fruergaard Jørgensen, will appear to answer the not-so-subtle charge of “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” at the Senate Health, Education, Labor, and Pensions (HELP) Committee. On April 24, Senate HELP Chair Bernie Sanders (I-VT) launched an investigation into Novo Nordisk’s pricing of Ozempic and Wegovy, two popular diabetes and obesity drugs. Chair Sanders threatened a subpoena vote to force testimony by the company’s President of North American Operations. That threat was dropped when the company’s global CEO Jørgensen agreed to testify instead. 

On September 24, 2024, one big thing we will be watching for is how much the ongoing presidential race impacts the hearing. Will Democrats use the event to highlight Vice President Harris’ plans to extend current caps on insulin and other prescription drugs to individuals outside of Medicare? Will Republicans bring up that the Trump Administration created a model to provide insulin to Medicare Part D beneficiaries for no more than $35 before the Inflation Reduction Act mandated it?  

The House  

The House Might Bounce Early  

What we are hearing is the House may not be back in town as long as previously advertised, instead choosing to adjourn a week early and be gone the last week of the month.  

So what? If the House does decide to leave early, it is not scheduled to return until after the deadline for passing legislation to keep the government open. Under the truncated schedule, the House would dedicate one week to focus on legislation related to China and one week to passing a continuing resolution (C.R.) to keep the government open.  However, as anyone familiar with Congress knows, passing government funding bills can be tricky.  

Health Care Hearings  

In addition to a China Week and consideration of a C.R., we are also hearing the possibility of health care bills being considered by the House Ways and Means Committee and the Energy and Commerce Committee before the end of September. Specifically, Ways and Means may be planning a catchall markup to consider several bills, including some related to health care. Energy and Commerce is rumored to be marking up health care legislation, including telehealth legislation. 

There You Have It 

As mentioned, NFL football returns this week, and your author is pumped, especially since his Green Bay Packers are playing in a special Friday game in Brazil (Go Pack Go!). Did you know that Jennifer Bell’s former boss, Sen. John Thune (R-SD), is a Packer fan? Bet you thought he was a Vikings guy. Nope! Who’s your favorite team? Let us know! Make it a great week!  

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!