Insights

Resetting the Race 

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!  

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Week Ahead: The Fireworks Aren’t Done Yet

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!

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Week Ahead: Of Convictions and Congress

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!

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It’s the Final Countdown: Recess and CRA Edition

With Congress back in session before they head home for Memorial Day parades and the unofficial beginning of summer next week, let’s see what they can move forward.  It is hard to believe but after this, the House and Senate both have 9 legislative weeks before breaking for the November elections. So, let’s jump in. Welcome to the Week Ahead!

The Administration

Biden Watching the CRA Clock

Before he can enjoy a nice ice cream cone at Rehoboth Beach, the President also huddling with his advisors to make sure the Administration gets as many rules published before the Congressional Review Act(CRA) deadline passes.

A CRA resolution allows a new Congress to overturn federal rules published after a certain date with only a simple majority and without the threat of a filibuster.  The Administration has been governing by regulation amidst this Congress and they want these rules to stick.

When’s the big day? The exact date is a bit unclear. A January analysis from Venable LLP predicted late June, but a February analysis from Hunton Andrews Kurth predicted May 22.

Marijuana Gets on a New Schedule

Now turning to a different type of schedule, on May 21, the Drug Enforcement Agency (DEA) Published a Notice of Proposed Rulemaking to transfer marijuana from a Schedule I drug (no medical value, high potential for abuse/dependency) to a Schedule III Drug (accepted medical use moderate to low potential for abuse/dependency).

So what? In 2020, then-candidate Biden promised to decriminalize Marijuana. This is not that. But it is something that the Biden campaign can point to as progress. Additionally, the Administration is certainly happy to get this published before the CRA deadline to protect therule from an easier repeal if Trump wins in November.

Senate

AI Working Group Lays Out a Roadmap

Sen. Majority Leader Schumer (D-NY) unveiled the Senate Bipartisan AI Working Group’s Roadmap for AI Policy last week.  The roadmap includes several health care proposals including, a call to fund AI R&D at NIH, guidelines to consider when developing health care legislation, and a reminder to give HHS and other health care agencies the tools to regulate AI.

Now what? We previously reported that committees were all over the place when it came to developing AI legislation. There is no reason to think that changes with this report. However, we will certainly be watching for AI as we monitor committee activity going forward…especially those committees with jurisdiction over health care.

Senate Health Hearing Schedule: Mad dash to Recess

The Senate certainly isn’t taking things slow in this last week before recess. Here is what we are watching this week

  • May 21: Senate Judiciary Committee hearing on competition in the prescription drug market
  • May 21: Senate HELP Primary Health and Retirement Subcommittee hearing on food as medicine
  • May 23: Senate Aging Committee hearing on the Older Americans Act
  • May 23: Senate Finance Committee hearing on the Fentanyl Crisis
  • May 23: Senate HELP Committee executive session to markup 7 health care bills
  • May 23: Senate Appropriations Interior, Environment, and Related Agencies Subcommittee, & Related Agencies hearing on the FY25 budget request for NIH

The House

House Examines Health Care Consolidation

The House Budget Committee will hold a hearing on May 23 entitled “Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation.”  Not to be outdone, the House Ways and Means Health Subcommittee will examine the impact of consolidation on independent medical practitioners on May 23, among other effects like regulatory burden.

So what? As we get closer and closer to the election, the time and likelihood for bipartisan action grows smaller. The issue of health care consolidation has recently gotten some love from both sides of the aisle as members of the Senate Finance Committee and the House Energy and Commerce Oversight Subcommittee brought up consolidation in hearings with United Healthcare’s CEO on the Change Healthcare attack and if United’s size made it too much of a target. It remains to be seen if the House Budget Committee can keep the love going.

Beyond the hearing room, we continue to watch for updates from the House Ways and Means Committee on a package of rural health proposals, which we anticipate in the coming weeks and months.

E&C Health Puts FDA Regs in the Crosshairs 

On May 22, the House Energy and Commerce Subcommittee on Health will hold a hearing  with the FDA directors of the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).

What to listen for? 

  • The FDA’s recently finalized rule on laboratory-developed tests (LDTs)
  • The impact of Medicare drug negotiation’s impact on innovation
  • An update on the recently stalled effort to ban menthol cigarettes

House Oversight Keeps Up the Pressure on NIH 

It’s not exactly shocking that a House subcommittee controlled by the opposite party from the White House is investigating the Executive Branch.  That said, those who are looking for something to be done in response to concerns about how the government funds biomedical research had something to celebrate with the news that HHS will be suspending funds to EcoHealth Alliance, an organization that some Republicans have accused of funding risky biomedical research with taxpayer dollars.

The House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic is scheduled to hold a hearing on May 23, with National Institute of Allergy and Infectious Diseases Senior Scientific Advisor, Dr. David Morens. This follows a May 1 hearing the subcommittee with the President of EcoHealth Alliance and a May 16 hearing with NIH Deputy Director Lawrence Tabak. It also follows the release of a transcript and memo on the subcommittee’s interview with former NIH Director Francis Collins.

So what? This leaves Subcommittee Ranking Member Ruiz (D-CA) to balance praising the Administration’s oversight actions without seeming to give credence to what many have called a conspiracy theory that Echohealth Alliance helped create the COVID-19 virus.

See Rep. Ruiz’s press release from the ranking member provides a look at how he is doing that so far and the upcoming hearing provides him with another opportunity.

 

There You Have It

As we slide into summer, Chamber Hill Strategies honors our military men and women who paid the ultimate sacrifice to secure, protect, and preserve the freedom we enjoy this Memorial Day. One of our favorite DC monuments in DC, the Korean War Memorial reminds us that that freedom is not free.  Make it a great week!

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Week Ahead: Congress Loves Rural

After a frenzied finish to last week that included a last-minute vote on legislation to reauthorize the Federal Aviation Administration in the Senate, and the bipartisan tabling of the motion to vacate House Speaker Mike Johnson in the House, the Congress reconvenes this week with only 2 work weeks before the Memorial Day break.  So, let’s get into it. Welcome to the Week Ahead!

The Administration

Cybersecurity Standards for Hospitals on the Horizon 

Deputy National Security Advisor for Cyber and Emerging Technology Anne Neuberger said that the Biden Administration plans to release a rule requiring hospitals to meet minimum cybersecurity standards in response to the Change Healthcare cyberattack in February, according to a Bloomberg News article republished on govtech.com.  She also said the administration plans to provide free training to small, rural hospitals who may have trouble meeting the standards.

Will the industry go along? We will be watching how stakeholders in the health care industry react to the news. An article published in the Record notes that Ms. Neuberger has argued that the industry has been asked to address cybersecurity concerns for more than a decade. But these arguments might be a moot point if the industry can find enough sympathy from members of Congress who have not been shy when it comes to pushing back on the administration’s rulemaking authority.

New DOJ Health Care Task Force Joins the Anti-Trust Parade

The Department of Justice (DOJ) Antitrust Division announced a new task force dedicated to addressing concerns about anti-competitive behavior in health care markets.  DOJ is also working with the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) to extend the comment period for an investigation into how corporate ownership affects health care.

One big question: Will this task force impact voters’ perceptions of Biden’s handling of the economy? As this task force gets going, we know President Biden must be aware of polls such as this one from Gallup that shows him fairing the worst of any president on the question of economic management since 2001. We expect the President to continue to tout his efforts to increase competition and break up trusts – including in health care. But will it be enough to capture the support of November voters?

Bird Flu on the Brain

HHS announced several actions it is taking actions to respond to a recent outbreak of the avian flu (H591) along with the U.S. Department of Agriculture (USDA). The actions announced by HHS to address the avian flu threat do not come cheap. According to the agency, the CDC and FDA investments announced on May 10  will cost more than $100 million.

What we will be watching for: Politico reported on discussions between FDA Commissioner Califf and Ranking Member Hoeven (R-ND) regarding a potential avian flu supplemental funding request.  If such a request comes, how will the President handle negotiations with a Republican House that has been skeptical of spending requests and public health proposals from this administration?

The Senate

Schumer Provides Update on AI Legislation 

When asked about the specific timelines for AI legislation, Senate Majority Leader Chuck Schumer (D-NY) shared at a recent event that the committees are all over the map:
•    Homeland Security, Commerce, and Rules committees are “pretty well along on this.”
•    The Senate committees with jurisdiction over health care and education as being “a little further back.”
He said the hope is to have legislation start to come out “within a few weeks throughout the summer and fall.”

Senate Health Hearings

The big hearing this week on health is at Senate Finance Committee entitled “Rural Health Care: Supporting Lives and Improving Communities on May 16.  Both the House and Senate committees have been working behind the scenes and with the administration on rural health policy, and this hearing will set the stage for further legislating this summer. Other hearings include:
•    May 15: Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies hearing entitled “A Review of the President’s Fiscal Year 2025 Budget Request for Indian Country.
•    May 15: Senate Veterans Affairs’ Committee hearing entitled “Frontier Health Care: Ensuring Veterans’ Access No Matter Where They Live.”
•    May 15: Senate Homeland Security and Government Affairs hearing to markup legislation, including S.4035, the FEHB Protection Act, which would direct the Director of the Office of Personnel Management to take certain steps to address concerns about improper enrollment in the health insurance program for federal employees.
•    May 16: Senate HELP Committee hearing entitled “Examining the Dental Care Crisis in America: How Can We Make Dental Care More Affordable and More Available?”

The House

Ways and Means Continues to Work on Rural  

House Ways and Means Committee took the first bite on a rural health package with the markup of telehealth and rural health legislation.  Telehealth was the only bill with a bipartisan vote, even though both Democrats and Republicans support improvements to rural health care.  Not to be outdone, House Energy and Commerce may be marking up telehealth legislation this week. Both the House and Senate would like to advance rural health legislation ahead of the August district work periods where they can tout legislative accomplishments to their constituents.
 
Becerra in the Hot Seat….Again 

HHS Secretary Xavier Becerra is once again returning to his old stomping grounds in the House when he testifies at a May 15 hearing at the House Education and Workforce Committee.   Other House health-related hearings include:
•    May 13: House Veterans’ Affairs Health Subcommittee field hearing entitled “Iowa: A Leader in Veteran Healthcare Innovation.”
•    May 16: House Oversight & Accountability Select Subcommittee on the Coronavirus Pandemic hearing entitled “Overseeing the Overseers: A Hearing with NIH Deputy Director Lawrence Tabak.” 

There You Have It

It’s going to be a busy one!  We want to join with those who have come to D.C. to honor our law enforcement officers for National Police Week and Peace Officers Memorial Day on May 15. Be sure to thank a police officer this week for what they do to keep our families and communities safe.

Here’s to a great week ahead – let us know your questions and feedback!

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The Horses Are Not the Only Ones Racing

Over the weekend, fans of horse racing enjoyed an exciting Kentucky Derby that ended with a narrow win for Mystik Dan! As Congress returns, members are already lining up for their own race to the Memorial Day recess and looking ahead to the big race of the 2024 elections. Welcome to the Week Ahead!

The Administration

Medicare Drug Negotiation: Round 2

The Centers for Medicare and Medicaid Services (CMS) published a notice alerting the public about an opportunity to comment on the agency’s draft guidance for the 2nd round of Medicare price negotiations as authorized by the Inflation Reduction Act (IRA). This round of negotiations will add another 15 drugs to the 10 drugs currently moving through the negotiation process. These 15 drugs are scheduled to be announced by February 1, 2025, and any negotiated prices will be effective by 2027.

There are some potential roadblocks in the way even as the Biden Administration is moving confidently along with implementing the IRA, including:

•    Legal challenges: Pharmaceutical companies and trade associations have brought several lawsuits to stop the negotiations, claiming that the action is unconstitutional and leaves drug manufacturers with little bargaining power because they either have to accept the government’s price or choose not to participate in the Medicare program.
•    A 2nd Trump Administration: It’s not clear that Trump’s return to the White House would spell the death of Medicare price negotiations. After all, during his first administration, Trump signed an executive order to direct Medicare to pay no more than the lowest price at which the drug is sold in any other developed nation. However, a 2nd Trump Administration would face tremendous pressure from congressional Republicans to end the program.

The Senate

Health Care Stowaway on FAA Bill

This week, the Senate is scheduled to resume consideration of H.R.3935, a bill to reauthorize the Federal Aviation Administration (FAA) through FY2028. Obviously, this is not a health care bill, but a little bit of what might be considered health care policy managed to sneak aboard the bill before it passed the House. Specifically, the bill bans the FAA from imposing mask or COVID-19 vaccine mandates on passengers, air carrier employees, or FAA employees. Not too long ago, such a provision would have probably caused a bit more of an uproar among Democratic members of Congress. But it appears Captain Schumer is planning for clear skies ahead.

FDA Chief to Defend Budget

Food and Drug Administration (FDA) head Dr. Robert Califf, is scheduled to testify before the Senate Appropriations Ag-FDA Subcommittee on May 8. Although the hearing is about the President’s FY25 budget request, we will also be listening to other topics related to the FDA, such as the recently finalized rule that gives the FDA the authority to regulate lab-developed tests or the delayed rule to ban menthol-flavored cigarettes

Also on Our Radar

•    The Senate Budget Committee will hold a hearing on Administrative Burdens in Health Care on May 8.
•    The Senate Armed Services Subcommittee on Personnel will hold a hearing on May 8 where Assistant Secretary of Defense for Health Affairs Lester Martinez-Lopez will be testifying.

The House

To Legislate or Motion to Vacate?  

The House has a full agenda on the floor but the question is, will House Republican leadership be able to keep things on track, or will they be derailed by Rep. Marjorie Taylor Greene’s (R-GA) motion to vacate against House Speaker Mike Johnson (R-LA)?

The good news for the Speaker: House Democratic leadership has announced they will table Rep. Greene’s motion to vacate the Chair. So, he is probably safe. For now.

The bad news for the Speaker: If Rep. Greene or someone else brings up another motion to vacate, will House Democrats step up again, and if so, what will they ask for in return?

Ways and Means Makes a Way on Health Care

Last week, we saw a lot of health care action from the House Energy and Commerce Committee with subcommittee hearings on Medicaid and the Change Healthcare cyberattack. Not to be outdone, the House Ways and Means Committee is expected to hold a full committee markup this week to consider legislation to extend telehealth flexibilities initiated during the COVID-19 public health emergency, along with some additional reforms and flexibilities.

So what? The markup on telehealth legislation will be the first time this year that a committee has marked up legislation to extend the telehealth flexibilities granted during the COVID-19 pandemic.

Other Health Care Hearings in the House  

Just in case you thought Ways and Means was going to have all the fun this week, here are some other health care hearings we are tracking in the House this week:

•    May 8: House Small Business Committee hearing on regulatory burdens on small businesses in healthcare
•    May 8: House Homeland Security Subcommittee on Counterterrorism, Law Enforcement, and Intelligence hearing on foreign anomalous health incidents
•    May 8: House Natural Resources Indian and Insular Affairs Subcommittee hearing on the FY25 Budget Request for the Bureau of Indian Affairs, Indian Health Service, and Office of Insular Affairs

There You Have It

Did you watch the big race? If so, did you get dressed up? If you didn’t watch, how did you spend your Saturday? Reach out and let us know. Here’s to a great week!

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Week Ahead: Congress Comes Back to Approps Season

Unseasonably cool weather in Washington last week left us feeling less than springy. However, we did see a thawing of relations between Republicans and Democrats on a foreign aid package. Additionally, the endorsement of Speaker Mike Johnson (R-LA) by former President Trump likely brings some feelings of rejuvenation to the embattled Speaker. The forecast this week calls for a return of Congress, a response to the Biden administration’s nursing home staffing mandate, and a possible rule on lab-developed tests (LDTs). Welcome to the Week Ahead!

The Administration

While Congress was out of session, the Administration dispatched several highly-anticipated final rules, including the nursing home staffing ratio rule, the Medicaid managed care rule, the Medicaid access rule, and an FTC ban on non-compete agreements, among others.

Banning menthol in cigarettes did not get finalized.  On April 26, Health and Human Services (HHS) Secretary Xavier Becerra acknowledged the need for more time, likely in part due to concerns that the rule would lead to increased law enforcement activity in minority communities.

4-1-1 on LDTs:  Despite all the regulatory activity, we are still waiting on a proposed rule granting the Food and Drug Administration (FDA) explicit authority to regulate LDTs. We expect that rule any day now.

The Senate

UnitedHealth Group CEO Comes to Town

United Healthcare Group CEO Andrew Witty testifies before Congress about the Change Healthcare cyberattack. His first stop will be a Senate Finance Committee hearing.

Some things we will be watching: 
•    Will GOP members use the hearing to criticize the Biden Administration’s response to the cyberattack, or will they focus their attention on UnitedHealth Group’s response?
•    Will any members discuss or propose legislative action to address broader concerns about cybersecurity? In particular, we will be watching to see if Sen. Mark Warner (D-VA) uses the hearing to advocate for legislation he introduced earlier this year that would tie federal payments to health care providers after a cyberattack to the adoption of cybersecurity standards.
•    How will Mr. Witty respond to allegations that United Healthcare has not done enough to help providers in the wake of the attack?

Other Notable Senate Hearings

  • April 30: Senate Armed Services Subcommittee on Personnel hearing on access to pharmaceuticals
  • May 2: Senate HELP Committee hearing on the shortage of minority health care professionals and the maternal health crisis

The House

Movement on Appropriations 

What’s happening: Last week, the House Appropriations Committee released guidance for members on FY 2025 Community Project Funding (earmarks). This comes as the House just finished FY 2024 appropriations only one month ago.

The House Labor, Health and Human Services Appropriations Subcommittee holds its Member Day on April 30.

What it means: The pace is quick: members must submit programmatic and language requests by May 1 and Community Project Funding Requests by May 3. We know how deadlines drive activity in DC!

House Energy and Commerce GOP Looks to Strike Back on Nursing Home Staffing Rule

What’s happening: On April 30, The House Energy and Commerce Health Subcommittee will consider the Protecting America’s Seniors Access to Care Act (H.R. 7513), which would block the implementation of the recently finalized minimum staffing rule during its legislative hearing entitled “Legislative Proposals to Increase Medicaid Access and Improve Program Integrity.”

Some Democrats have crossed the aisle to support this bill. Rep. Jared Golden (D-ME) is one of the bill’s cosponsors, and Rep. Terry Sewell (D-AL) supported the bill’s passage out of Ways and Means. That being said, most Democratic members are supporting the administration’s action. Given the small majority Republicans hold in the House, not to mention the Democratic majority in the Senate and Democratic President, getting this bill across the finish line may be a tall order.

In Other House Committee News 

  • The House Oversight Select Subcommittee on the Coronavirus Pandemic will hold a hearing on May 1 with the president of EcoHealth Alliance. EcoHealth Alliance has been accused by some House GOP members of funding risky gain-of-function research so this hearing will certainly be feisty.
  • After his appearance before the Senate Finance Committee on the morning of May 1, UnitedHealth Group CEO Andrew Witty will be crossing over to the House for an Energy and Commerce Oversight Subcommittee hearing about the Change Healthcare cyberattack.

There You Have It

What are your favorite springtime activities? Did you get to do any spring break traveling this year? Reach out to share and compare. Here’s to a great Week!

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They Say Health Care Policy is a Marathon, Not a Sprint

It’s Patriots’ Day, and our very own Jennifer Bell is taking this whole marathon-not-a-sprint thing seriously by tackling the Boston Marathon again. In DC this week, the drone and missile attack on Israel from Iran will dominate floor activity even as Congress has a slew of hearings ahead of the April 22 break for Passover. So, let’s see what the week holds – welcome to the Week Ahead!

The Administration

The Iranian attack will have big implications for Washington – putting pressure on Congress to move on stalled foreign aid packages and on the Biden administration to stand with Israel as some progressive critics call for him to condition aid on efforts to prevent civilian casualties.

Everybody Wants to Rule the World…

What’s happening: On the health care front, the hospital lobby is criticizing the FY 2025 Inpatient Prospective Payment System Proposed Rule for not keeping up with inflation. The proposed rule came out just ahead of this week’s American Hospital Association Annual Meeting.

What’s on deck:  While still under review at OMB, we are keeping our eyes peeled for the Medicaid access rule. We aren’t feeling the final versions of the laboratory-developed test rule or the minimum-staffing standards for long-term care rule coming out this week since OMB is still conducting stakeholder meetings.

The Senate

Senate Subcommittee Weighs in on HHS Budget

What’s happening:  With the 2024 appropriations process now in the rearview mirror, the Senate Appropriations Committee will hold several budget-related hearings this week—including one with Health and Human Services Secretary Xavier Becerra. Sec. Becerra will be testifying on the President’s proposed FY2025 HHS budget before the Senate Labor, Health and Human Services Subcommittee on April 16.

Why it matters: This will be the 4th appearance by the Secretary on the budget, with one additional one later in the week in the House. Will the Secretary be pressed on the administration’s response to the cyberattack on Change Healthcare or funding related to the Medicare drug negotiations in the Inflation Reduction Act? Will he be checked out as rumors fly about his potential exit to run for governor of California?  We are betting the Secretary will be fully engaged.

Another Impeachment Senate Hearings 

What’s Happening: While leaders debate how to respond to the attacks on Israel, we doubt the Senate will have much appetite to take up impeachment articles against Homeland Security Secretary Alejandro Mayorkas. The House voted to impeach the Secretary in February, but they have yet to send the articles over to the Senate.

Senate Hearings 

Other notable hearings this week include:

  • April 16: Senate Aging Committee hearing on the Long-Term Care Workforce
  • April 17: Senate HELP Primary Health and Retirement Security Subcommittee hearing on food as medicine
  • April 17: Senate Armed Services Subcommittee on Personnel hearing on servicemembers’ access to safe, quality pharmaceuticals
  • TBD: Last week, during a Senate Finance Health Subcommittee hearing on substance use disorder care in federal health care programs, Subcommittee Chair Ben Cardin (D-MD) said that Committee Chair Ron Wyden (D-OR) plans to have a full hearing on opioids and fentanyl

The House

Mike Gets a Win
 
What’s happening: Last week, the House of Representatives passed legislation to renew the Foreign Intelligence Surveillance Act (FISA) after opposition from some Republicans caused previous votes to fail.

Why it matters: Beyond the significance of the legislation itself, this vote shows (at least for now) that Speaker Mike Johnson (R-LA) can still get things through Congress. Before the weekend, the question was about whether he could maintain control of his caucus as he seeks to pass potential Ukraine aid legislation.  Now, with the schedule to be dominated by yet-to-be-announced legislation regarding Israel, we expect threats to oust the Speaker will die down for a few days at least.

Jam-Packed Tuesday

What’s happening: The House is starting the week off hot with several health care-related hearings.

  • April 16: House Energy and Commerce Health Subcommittee hearing on cybersecurity in the health care sector following the Change Healthcare attack
  • April 16:  House Education and Workforce HELP Subcommittee hearing on ERISA
  • April 16:  House Energy and Commerce Oversight and Investigations Subcommittee hearing on Medicare and Medicaid fraud
  • April 16:  House Veterans’ Affairs Health Subcommittee Markup of health care legislation

Why it Matters: Even though the House is spending a lot of floor time on issues than health care these days, health care legislation is still on the front burner in the committees.

Becerra Returns to the House 

What’s happening: HHS Sec. Becerra is scheduled to testify before the House Energy and Commerce Health Subcommittee on April 17 about the FY25 HHS budget.

Does it matter?  Even as Energy and Commerce gets its time with the Secretary, the bigger impact on the President’s budget proposal is arguably last week’s selection of Rep. Tom Cole (R-OK) as the new House Appropriations Chair.

House Energy & Commerce Subcommittee Considers Privacy Legislation 

What’s happening: The House Energy and Commerce Innovation, Data, and Commerce Subcommittee is scheduled to consider several legislative proposals related to data privacy on Wednesday. Among the proposals to be considered is a draft of the American Privacy Rights Act, which includes provisions related to health care data.

Why it matters: This bill was introduced by House Energy and Commerce Chair Cathy McMorris-Rodgers (R-WA) and Senate Commerce Committee Chair Maria Cantwell (D-WA). That means this bill is bipartisan, bicameral, and has support from two committee chairs. These facts bolster chances for success. The question is, will that be enough to move this bill during an election year?

So, there you have it!  Did you get your taxes in?  Did you know 2 states celebrate Patriots’ Day?  Reach out to us if you know the other one that is not Massachusetts. Here’s to a great week!

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Health Care Policy in the 2024 State of the Union Address

Health Care Policy in the 2024 State of the Union Address  

Heading into election season, President Biden delivered his annual State of the Union Address with a number of familiar health care policy mentions. This blog post focuses on what the President talked about, the implications of those issues for 2024, and the chances of movement on these issues in the current Congress.  

Inflation Reduction Act  

President Biden highlighted the passage of the Inflation Reduction Act (IRA) and the health care provisions in the bill including: 

  • Medicare drug price negotiations, 
  • expanded ACA subsidies, and  
  • the out-of-pocket cap on insulin and other prescription drugs for Medicare beneficiaries.  

He called for building on this legislation by expanding Medicare negotiation authority to include more drugs, making the expanded ACA subsidies permanent, and extending the out-of-pocket caps to all Americans. President Biden’s focus on these provisions makes sense given polls such as this one from KFF that show Americans are not very familiar with the specifics of the IRA.  

Abortion 

President Biden spoke forcefully about his view that reproductive rights should be protected. Polls, such as this one from KFF, show that the issue is very important as a motivator for the Democratic base and key constituencies. President Biden called for Congress to send him a bill to make Roe v. Wade the law of the land. He also highlighted his opposition to state bans on abortion or efforts to curtail access to services such as IVF.  

Protecting Medicare 

President Biden reiterated his opposition to what he described as efforts to cut Medicare. This portion of the speech elicited jeers from the Republican side of the aisle. As we mentioned in a previous blog, this issue is especially important for older voters, so we expect the President to continue to highlight ways his administration is protecting Medicare, especially in geographical areas with high concentrations of older voters.  

Hope for Bipartisanship 

President Biden did include some areas of health care policy in the 2024 State of the Union where there is strong potential for bipartisanship. For example, the president spoke about: 

  • federal funding for the ARPA-H and  
  • efforts to address concerns about fentanyl.  

The President also mentioned a new Women’s Heath Research initiative that he will be asked Congress to fund in the coming days. 

So What?  

It is difficult to see how Congress can move on any major health care legislation before the election, given the fragile majority Republicans hold in the House and the almost-default requirement for at least 60 votes in the Senate.  It was certainly important for the President to bring up these ideas given how much voters want to hear from the president and his opponent about their respective health care policy proposals. If there is going to be any movement in Congress on health care policy in this election year, we expect areas of health care policy in the 2024 State of the Union such as federal funding for cancer research and efforts to address concerns about fentanyl to be the areas where any movement occurs.  

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What Happened, What You Missed: December 11-15, 2023

HHS Finalizes Rule on Interoperability, AI Transparency 

A newly finalized rule from the Department of Health and Human Services (HHS) marks the federal government’s first attempt to regulate the use of artificial intelligence (AI) in health care.  Specifically, the rule establishes transparency requirements for AI and predictive algorithms that are used to support clinical decision support (CDS) and decision support interventions (DSIs).  HHS says the rule will support the widespread use of AI in health care, which proponents say could help reduce administrative and clinical burden.  The rule will also support interoperability by requiring developers of certified health IT to report certain metrics, which will better inform how health IT is used in health care delivery. 

GAO Reports on No Surprises Act’s Rocky Implementation 

The federal government is seeing far more disputes between commercial insurers and health care providers over out-of-network bills than anticipated, according to a report by the Government Accountability Office (GAO).  Enacted in 2021, the No Surprises Act established a baseball-style independent dispute resolution (IDR) process for insures and providers to settle payment disagreements to protect patients from receiving unexpected balance bills.  As of June 2023, the federal government has received nearly 490,000 payment disputes – a far cry from the initially projected figure of 22,000.  Nearly 61% of these disputes remain unresolved, which the GAO attributes to the difficulty of determining which disputes are eligible for the federal IDR process.  The federal government has proposed that insurers and providers submit more information up front to help address the high volume of disputes.   

FDA to Consider Psychedelic Drugs for PTSD Treatment 

The Food and Drug Administration (FDA) will consider approval of the psychedelic drug MDMA in conjunction with other intervention to help treat post-traumatic stress disorder (PTSD), according to the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), which recently filed a new drug application (NDA) with the agency.  If the new treatment is approved, the Drug Enforcement Administration would be required to reschedule MDMA to make it available for prescription use.  Also known as ecstasy, MDMA has been studied since the 1970s to help patients process certain experiences and emotions.  The company’s NDA focuses on two lates-stage clinical trial studies showing patients receiving three doses of MDMA saw a higher reduction of PTSD symptoms than those receiving a placebo. 

CMS: Health Spending Returns to Pre-Pandemic Levels 

Health care spending in the US increased 4.1% in 2022 to $4.5 trillion, or $13,493 per person, according to new data from the Centers for Medicare and Medicaid Services (CMS).  This growth rate is within range of a 4.4% average growth in spending between 2016 and 2019, signifying a return to pre-pandemic health care trends.  Health care spending growth spiked to 10.6% in 2020 before declining to 3.2% the following year.  The data also found a record high of 92% of Americans were insured last year, although this record may not last due to declining Medicaid enrollment as states continue their Medicaid redetermination process.  As far as goods and services go, prescription drug spending increased the most in 2022 at 8.4%, while spending on physician and clinical services jumped 2.7%.   

ICYMI: Ex-Speaker McCarthy Bids Adieu to Congress 

Rep. Kevin McCarthy (R-CA) gave his final floor speech on Thursday.  The floor speech was delivered in what’s likely to be McCarthy’s last legislative day in Congress, as the California Republican is expected to officially resign by the end of 2023.  McCarthy notably expressed no regrets about his decision to advance a clean continuing resolution on the House floor in September, which ultimately lead to his ouster from the speakership.  While McCarthy delivered his remarks before a largely empty House chamber, two close allies – Reps. Patrick McHenry (R-NC) and French Hill (R-AR) – were in attendance to offer their well wishes. 

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