Insights^

Congress returns just in time to consider a bipartisan agreement to keep the government funded through December.  On the other side of Pennsylvania Avenue, Ukrainian President Volodymyr Zelenskyy is coming to meet with President Biden and Vice President Harris about the state of the war against Russia. Let’s see what this consequential week holds. Welcome to the Week Ahead! 

The Administration  

Yet Another Obamacare Challenge 

The Department of Health and Human Services (HHS) has requested the Supreme Court review a court decision that partially blocked enforcement of the Affordable Care Act (ACA) mandate for employers to cover certain preventive health services at no-cost. At issue in this challenge is the ruling by the 5th Circuit Court of Appeals that members of the U.S. Preventative Services Task Force (USPSTF)were not properly appointed under the U.S. Constitution’s appointments clause (governing the appointment of Executive Branch officials). The ACA requires that private insurers cover at no cost services that the USPSTF has rated either “A” or “B” (meaning the panel finds that the services have a substantial or moderate net health benefit.) 

Will the Supreme Court take up this challenge, and if they do, how will the new Administration respond?  We will also be watching to see to what extent fights about the ACA impact the election, especially with Republican Vice Presidential candidate J.D. Vance’s recent reopening the issue on the campaign trail. 

FTC Sues PBMs 

In other health care legal news, the Federal Trade Commission (FTC) announced legal action against the three largest pharmacy benefits managers (PBMs), arguing that these entities have engaged in anticompetitive practices designed to increase profits from insulin.  

The Biden Administration has made addressing concerns about anti-competitive economic practices a top priority, and the FTC has been a leader in those efforts. The agency has faced both internal and external criticism for being too political, but Lina Khan, the agency’s chair, has won bipartisan praise from at least one Republican – J.D. Vance. This means regardless of who wins the White House in November, Chair Khan will have at least the potential for an ally in either Administration. 

The Senate  

Rare Pediatric Disease Priority Review Voucher Program Gets HELP Vote  

The Senate Health Education, Labor, and Pensions Committee will hold a markup on September 26. This markup includes health care legislation such as S. 4583, which would reauthorize the Rare Pediatric Disease Priority Review Voucher Program through September 30, 2024. A similar version of this bill passed out of the House Energy and Commerce Committee in May and both bills have bipartisan support.  

Legislation to reauthorize the Rare Pediatric Disease Priority Review Voucher Program has garnered bipartisan support in both chambers. However, it has also faced criticism based on concerns that not enough oversight is being done to ensure it is meeting its goal of incentivizing the development of rare pediatric disease treatments. We will be watching to see what the Senate HELP Committee will do in regards to legislation to reauthorize this program.  

Health Care Hearings 

• September 24: Senate Health, Education, Labor and Pensions Committee hearing on Novo Nordisk’s pricing of diabetes and obesity medication 

• September 24: Senate Finance Committee hearing on women’s reproductive health care 

• September 25: Senate Homeland Security and Governmental Affairs Committee business meeting, including re: S.4667, the Risk Research Review Act 

• September 26: Senate Environment and Public Works Superfund, Waste Management, and Regulatory Oversight Subcommittee hearing on the public health impacts of PFAS exposure 

• September 26: Senate Health, Education, Labor, and Pensions Committee executive session to consider legislation  

The House 

More Health Care Bills on the Docket  

Just like last week, the House has several health care bills on its schedule for floor action the week of September 23. This list of bills includes legislation related to pediatric drug development (H.R. 3433) and Medicaid coverage for U.S. service members (H.R. 8108) that just passed out of Energy and Commerce on September 18. 

Notably absent from the list: Legislation to extend COVID-era telehealth flexibilities, such as the Telehealth Modernization Act (H.R.7623), which also passed out of the Energy and Commerce Committee on September 18. As a reminder, those flexibilities are set to expire at the end of the year. We will be watching for action on this when Congress returns in November. 

Healthcare Hearings 

• September 25: House Veterans’ Affairs Committee hearing on supporting the Veteran caregiver community 

• September 26: House Oversight and Accountability Health Care and Financial Services Subcommittee hearing on recent Biden Administration action related to Medicare Part D  

There You Have It 

Election season is in full swing, with early voting already underway in three states! Are you registered to vote? If not, get registered here. Make it a great week!  

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!  

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!  

Donald Trump made history on May 30 as the first former President to be convicted of a felony. Congress now returns for the first time since that conviction, and many lawmakers will be focusing their attention on the fallout from the verdict. We won’t add to the pile of punditry that has already been printed but will instead focus on the latest health care policy news.  Welcome to the Week Ahead!

The Administration

ACLA Tests the Legal Waters with LDT Lawsuit

As the former president prepares his appeal, the Food and Drug Administration (FDA) is preparing for a legal fight of its own. On May 29, the American Clinical Laboratory Association (ACLA) announced it was filing a lawsuit against the FDA to stop the agency’s Final Rule to regulate laboratory-developed tests (LDTs) as medical devices. The ACLA argues that Congress never gave the FDA the authority to regulate these tests.

So what?  The lawsuit is just the latest effort by the ACLA to stop this rule from going into effect. We expect the lab industry to follow the lawsuit with increased lobbying. Some Republicans on the House Energy and Commerce Committee have expressed concerns about potential unintended consequences from the rule, but what will become of efforts to pull back the rule?

Senate

Multiplan Madness

Senate Finance Committee Chair Wyden (D-OR) and Senate HELP Committee Chair Sanders (I-VT) are looking to get answers from Mutliplan regarding concerns about certain practices the company uses when negotiating out-of-network payment rates for insurers. Specifically, the Senators are concerned these practices increase costs for patients and may be allowing insurers to skimp on fulfilling their obligations to patients. They requested a response by June 5. Here are some things to watch for:

• Will the two Democratic chairs get any help from their GOP Ranking Members?
• Will we see any corresponding action in the House?

Senate Health Care Hearings 

• June 4: Senate HELP Committee hearing on the Impact of Abortion Bans on Women’s Health
• June 5: Senate Special Committee on Aging and Senate VA Committee hearing on Services for Veterans and Their Caregivers

The House

Checking in with Ways and Means

Work continues behind the scenes at the House Ways and Means Committee on provisions that could find their way in a late year, post-election health care package:

• Telehealth: It sounds like a 2-year extension of telehealth flexibilities is picking up steam and is likely before year’s end. While advocates would love action before the November elections, it’s unclear at best if Congress can agree on addressing the issue sooner than December.
• Rural health: In addition to the bills passed out of the Committee at its May 8 markup, the Committee is hoping to move additional rural bills before summer’s end. Any measures cleared by the Committee will be in play to move in a larger health package during the lame duck session.
• Medicare physician payment: With Congress waiting for the release of the Medicare physician fee schedule in late June, it’s hard to see any significant movement on Medicare payment legislation before the election. In addition, word is that there is growing interest among policymakers in H.R. 6371, the Provider Reimbursement Stability Act, which would address Medicare’s budget neutrality requirement.

House Health Care Hearings

• June 3: House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing with Dr. Fauci
• June 4: House Energy and Commerce Oversight and Investigations Subcommittee hearing on 340B Drug Pricing Program
• June 4: House Natural Resources legislative hearing, including H.R. 6395, Recognizing the Importance of Critical Minerals in Healthcare Act of 2023

There You Have It

Summer is officially here! Have any big summer travel plans? Favorite summer- time activities? Let us know! Make it a great week!