Insights

With the first (only?) Harris vs. Trump debate behind us, Congress is looking to get a funding deal as they try to get back on the campaign trail ahead of the election. We are hearing the chances are increasing for a bipartisan continuing resolution, but with this Congress in this election cycle, anything is possible. With that, let’s get into it. Welcome to the Week Ahead!  

The Administration 

The Department of Health and Human Services’ Office of Research Integrity ( HHS ORI) is scheduled to publish a rule on September 17 that finalizes the 2024 Public Health Service (PHS) Policies on Research Misconduct, which has not been updated for 19 years. HHS noted that many public comments on this rule expressed general support for better execution and oversight of research misconduct proceedings.  

Oversight of federally funded research has also recently received bipartisan interest in Congress. On September 9, the House of Representatives passed the BIOSECURE Act (H.R.8333) by a vote of 306-81. This bill would prohibit federal agencies from awarding contracts, loans, or grants to biotech companies owned by foreign adversaries. We will be watching to see if this bipartisan interest in oversight of federal funding of research continues into the next Administration and the next Congress.  

The Senate  

Schumer Plans Second Vote on IVF Bill 

Senate Majority Leader Chuck Schumer (D-NY) announced that the Senate plans to hold a second vote on legislation to protect access to vitro fertilization (IVF), a type of fertility treatment. Sen. Schumer has criticized Republicans for previously opposing bringing the legislation up for a vote in June (although Sens. Lisa Murkowski (R-AK) and Susan Collins (R-ME) did vote to bring the bill up for debate).  

We do not expect the bill to move forward this time around, and we suspect Sen. Schumer knows it won’t either. But it is a good opportunity for the Majority Leader to highlight the issues of abortion access and reproductive health, which have generally been seen as winning issues for Democrats following the overturning of Roe v. Wade.  

SFC Highlights IRA Ahead of November  

Speaking of highlighting issues before the election, the Senate Finance Committee is scheduled to hold a hearing on the impact of the Inflation Reduction Act on health care costs. As is often the case with congressional hearings, you can identify how the majority feels about the issue or issues being addressed in the hearing by the title: “Lower Health Care Costs for Americans: Understanding the Benefits of the Inflation Reduction Act.”  

We expect Democrats on the committee to use the hearing to praise the Biden-Harris (with perhaps more emphasis on Harris) Administration for implementing the law and highlight how Medicare is already in the process of negotiating drug prices for Medicare beneficiaries to reduce costs. Expect Republicans to counter with charges that the law implements price controls that deny seniors access to innovative treatments and will cause health plans to raise premiums.  

Other Senate Health Hearings     

• 9/18: Senate Homeland Security and Governmental Affairs Committee business meeting (agenda includes S.4667, the Risky Research Review Act, to create a board to oversee potentially risky scientific research) 

• 9/19: Senate Health, Education, Labor, and Pensions Committee executive session to consider contempt resolutions against Steward Health Care CEO for refusal to testify  

The House 

Health Markups Maybe on the Horizon  

It sounds like some health care bills might make an appearance in upcoming House Committee markups. Specifically, we are hearing that the House Energy and Commerce Committee is looking to a markup this week which may include extending COVID telehealth flexibilities and other health care bills. Additionally, the House Ways and Means Committee might be looking to move on rural health legislation before the House adjourns at the end of September.  

We will be watching to see if any of these bills make it into an end-of-the-year legislative package.  

Health Care Week at Last? 

We previously reported on the potential for a “health care week” where the House might consider several bills related to health care. Although that never materialized, we expect to see a lot of health care action this week.  

House Majority Leader Steve Scalise (R-LA) announced the schedule for floor action that includes several health care bills on topics such as Medicaid access to care, reauthorization of funding for disease-specific research programs, telemedicine, and more. You can find the list of these bills (along with links to bill text) here.  

Passing the House is one thing, but might these bills be included in an end-of-the-year legislative package?  It’s always easier to get bills included in an end-of-the-year package if they are bipartisan and have passed one chamber of Congress. The health care bills that could be considered this week all meet the first part of that criteria. For example, H.R.4758, the Accelerating Kids’ Access to Care Act has 76 Democratic and 48 Republican cosponsors.  

Other Health Care Hearings  

• 9/18: House Ways and Means Health Subcommittee hearing on chronic disease prevention and treatment 

• 9/18: House VA Health Subcommittee hearing on oversight of the Veterans Suicide Hotline 

• 9/18: House VA Health Subcommittee markup  

There You Have It 

On September 17, we celebrate Constitution Day because this is the date the document was signed back in 1787. Check out this list of facts about the Constitution from the National Archives. Do you have any fun facts about the Constitution? Let us know! Make it a great week!  

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!