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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How does the Chevron Decision affect health care policy?

On June 28th, the Supreme Court ruled to overturn the “Chevron” deference doctrine (in Loper Bright Enterprises v. Raimondo). The 1984 Chevron defense directs the nation’s courts to defer to a government agency’s interpretation of statute under circumstances where the law was vaguely written. The June 28th ruling shifts the deference away from the executive branch to the judicial branch when congressional intent is implicit. 

Analysts and legal scholars agree that this will have dramatic consequences for health care, calling into question government rules on everything from nursing home care to clinical lab regulation to coverage mandates under the Affordable Care Act (ACA).  

Why will this shift affect so many aspects of health care? First, federal laws are often written vaguely to provide agencies flexibility to implement the changes as needed. That vagueness allows technical and scientific experts to make real-world policy decisions on how to implement what Congress passes. So, 50+ years of healthcare policy in action is now open to challenge, re-writing, and nullification.  

Second, the ruling will unleash a torrent of litigation. One friend of the court brief filed by the American Cancer Society and other organizations stated that this ruling would open a “litigation tsunami” on even long-settled healthcare policy. This could leave regulation with even more holes depending on rulings in different local, state, and federal courts – causing providers, insurers, and other healthcare players to struggle with compliance. 

Third, the ruling could lead to more uncertainty and less stability for players in the healthcare system. For example, even simple things like the government deciding what to pay hospitals or physicians could be subject to long legal battles that could disrupt payments and patient care.  

Lastly, this could significantly delay any enactment of new policies by the agencies and Congress. For example, scholars are pointing out that the FDA is extremely risk adverse and this ruling could significantly delay the release of new drugs and treatments. Congressional experts are also warning that this could slow the Congressional draft/legislating process even more as Congress would have to take more time drafting their legislative language to avoid future legal challenges. This could also pose a significant threat to those issues that need faster rulings – like supplemental appropriations (e.g., funding for things like the war in Ukraine) or regulations surrounding use of Artificial Intelligence (AI).   

We will continue to watch as things unfold, but it is extremely likely that new lawsuits will be filed to stop the nursing home staffing rule, the LDT lab rule, and price negotiations for Medicare drugs.  

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Week Ahead: Ready or Not Here It Comes

The first presidential debate for the 2024 electionis upon us, with President Biden and former President Trump set to take the stage in Atlanta on June 27. As the candidates and the country prepare, we at Chamber Hill Strategies are also watching for the release of two proposed Medicare rules, a possible Ways and Means markup, and more. So, let’s get into it, welcome to the Week Ahead!

The Administration

Summers in Washington bring blazing heat and crowds of tourists. Summer is also when we start seeingthe arrival of more Medicare payment proposed rules. So as the temperature climbs,we are hearing these 2 rules could be released as early as June 28:

  • Proposed CY 2025 Physician Fee Schedule Rule: The PFS is how the Centers for Medicare and Medicaid Services (CMS) pays for physician services, incidental services, non-clinical laboratory diagnostic tests, and radiology services.
  • Proposed CY 2025 Outpatient Prospective Payment System. The OPPS is how CMS generally pays for hospital outpatient department services.

We are eagerly anticipating the rules governing the Home Health Prospective Payment System and the End-Stage Renal Disease Prospective Payment System, but those are still under review at the Office of Management and Budget.

These proposed rules are vitally important to health care providers and the Medicare beneficiaries they serve. They also provide an opportunity for the Administration to advance health care priorities with a Republican-controlled House and a Senate that lacks a filibuster-proof majority for Democrats. For example, we could see the Administration try to advance payment policies in the PFS that require inclusion of data on social determinants of health. We might also see the Administration include provisions in the OPPS rule designed to encourage hospitals to adopt stronger cybersecurity protections. We will be watching closely for the release of these rules and diving into the details as soon as they come out.

The Senate

The Senate is out of session until after the 4th of July Holiday. We will provide updates when they return the week of July 8.

The House

Ways and Means Looks at Innovative Products

Rumor is that that the House Ways and Means Committee could meet this week to mark up legislation that would extend Medicare coverage for new and innovative technologies and products.  While the markup has yet to be noticed, the Committee’s interest in advancing coverage for newly developed treatments and devices is not a secret in health policy circles. One possible candidate for consideration is H.R. 1691, the Ensuring Patients Access to Critical Breakthrough Products Act, which was introduced last year by Ways and Means member Rep. Brad Wenstrup (R-OH) and fellow committee members, Reps. Suzan DelBene (D-WA), Blake Moore (R-UT), and Rep. Terrie Sewell (D-AL); the bill would extend temporary Medicare coverage to devices approved under the Food and Drug Administration’s Breakthrough Devices Program.  Also, rumored for possible consideration is H.R.5389, National Coverage Determination Transparency Act, which counts committee member Rep. Mike Kelly (R-KY) among its lead cosponsors. The legislation which was introduced by Energy and Commerce Health Subcommittee Chair Rep. Brett Guthrie (R-KY) was approved by the Energy and Commerce Committee in December.

These bills both become prime contenders for a House vote during a possible “health care week” in July.

Other Health Care Hearings on the Radar

  • June 26: House Ways and Means Health Subcommittee hearing on Value-Based Care
  • June 26: House Veterans Affairs’ Oversight Subcommittee hearing on the VA’s Healthcare Network
  • June 27: House Education and the Workforce Health, Employment, Labor, and Pensions Subcommittee hearing on the Employee Benefits Security Administration
  • June 27: House Appropriations Labor, Health and Human Services, Education Subcommittee Markup

There You Have It

Did you know that the first televised debate about a presidential election featured two women? That’s right,in 1956, former First Lady Eleanor Roosevelt, acting as a surrogate for Democratic candidate Adlai Stevenson, debated Sen. Margret Chase Smith, acting as a surrogate for Republican President Dwight Eisenhower. Do you know any other fun facts about presidential debate history? If so, let us know! Make it a great week!

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Week Ahead: It’s Quiet…Too Quiet

After two tumultuous weeks dominated by historic trials, reactions to an Israeli hostage recuse mission, and a visit to Capitol Hill by former President Trump, this week looks to be a lot quieter. But looks can be deceiving, and things are always going on behind the scenes in this town if you know where to look. So, let’s get to it. Welcome to the Week Ahead!

The Administration

OMB on the Clock to Review DEA Rule on Prescribing Controlled Substances Via Telehealth

The Office of Management and Budget (OMB) has received a proposed rule from the Drug Enforcement Agency (DEA) that would allow individuals to be prescribed certain controlled substances from a practitioner utilizing telehealth even if they had not had an in-person evaluation from the practitioner. The proposed rule would only apply to non-narcotic schedule III-V controlled medications when certain circumstances are met.

The DEA currently has temporary telehealth flexibilities in place through the end of the year. If the agency does not finalize its proposed rule before then, patient advocates argue that those who have been utilizing the flexibilities will face barriers to prescriptions for conditions such as ADHD.

The Senate

Senate Finance Chair Readies Rural Maternal Health Bill

Senate Finance Committee Chair Ron Wyden (D-OR) announced on June 14 that he will be holding a press call on June 17 to preview legislation he plans to introduce to address concerns about the availability of maternal health services in rural areas. The press call is scheduled for 2 PM EST.

Both rural and maternal health care are areas with huge potential for bipartisanship. But the devil is in the details…

While the House is Away the Senate will Play…Detective

What do you do if you’re in the Senate, but the House is out of session? Of course, you can vote on nominations. But It’s a lot more fun to hold investigations on hot button issues that are sure to make headlines. We are tracking a couple of such investigations in 2 committees this week.

  • Senate Health, Education, Labor, and Pensions (HELP) Committee
    • o   Chair Bernie Sanders (I-VT)was ready to hold a vote to subpoena Novo Nordisk’s President of North American Operations to testify about the company’s pricing of Ozempic and Wegovy in the United States.
    • However, Chair Sanders dropped his threat after the company’s global CEO Lars Fruergaard Jørgensen said he will testify at a hearing scheduled for September, according to Inside Health Policy.
    • This sets the stage for a potentially dramatic hearing 2 months before the 2024 elections.
    • But Novo Nordisk is not out of the woods yet, because the HELP Committee is still scheduled to vote to authorize an investigation into the company at a hearing scheduled for June 18.
  • Senate Homeland Security and Governmental Affairs Committee (HSGAC)
    • HSGAC is scheduled to hold a hearing on the origins of the COVID-19.
    • We’ve seen a lot of action on this issue in the House Oversight Committee, with Republicans and Democrats often disagreeing about what the focus of those efforts should be (even issuing conflicting reports).
    • But this is the Senate.  And the Senate is controlled by Democrats. Will we see bipartisan agreement about needed actions to understand the origins of COVID-19, unlike the partisan outcomes of the House hearings?

The House

The Ways to End a Month and What it Means

The House is in recess, so we are looking ahead to when they return. As we wait, we are tracking rumors that the Ways and Means Committee may be planning a markup related to innovation and medical coverage issues.

So What?

After July ends, we go to August recess and the unofficial final push to the November elections. As that date gets closer, many members of Congress will start having more things to do outside of Washington (and we are not talking about field hearings). These rumored hearings might be some of the last ones we see from the committee until after the elections or even until after the end of the year.

There You Have It

One of the reasons this week is so quiet is because Wednesday, June 19 is Juneteenth, the federal holiday that marks the date when the news of emancipation reached slaves in Texas in 1865. As we take time to celebrate this important date, we look back on progress so far and recognize the work that still needs to be done to form a more perfect union with liberty and justice for all.  Make it a great week!

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Week Ahead: Trying Times in Washington

Not two weeks have passed since the historic felony conviction of former President Trump, and now we could be heading towards another historic felony conviction, this time for Hunter Biden, the son of the current president. If these last few weeks have shown us anything, they show us that history stops for no one. So, let’s get to it. Welcome to the Week Ahead!

The Administration

JUUL Catches a Break from FDA

The Food and Drug Administration (FDA) announced the agency is rescinding its marketing denial orders (MDOs) against JUUL Labs, Inc. tobacco products, including e-cigarettes on June 6. These MDOs, issued on June 23, 2022, called for JUUL tobacco products to be removed from the market. Weeks later, FDA issued an administrative stay on the MDOs on July 5, 2022, because “certain scientific issues warranted additional review.” In its June 6 update, FDA cited this review and recent court decisions as the basis for the recession. The agency was clear in its announcement that the decision is not an authorization or denial of JUUL’s marketing applications and that the applications are once again under review.

JUUL wasted no time in celebrating the announcement and noted that JUUL products would be on the market during the review process.

Now What? 

  • Health advocacy groups, such as the American Lung Association and the Campaign for Tobacco-Free Kids, expressed disappointment regarding the decision.  What next steps will they take to pressure the FDA to pull JUUL products from the market?
  • What will congressional opponents of e-cigarettes do in response to this decision?  Appropriations season is underway, and opponents could use funding legislation to direct or block agency action.

Save the Date: June 20 is when the Supreme Court is scheduled to hear a request from the FDA to overrule a previous court ruling that found FDA had to consider applications for e-cigarettes one at a time, and could not just reject all of them, according to Inside Health Policy.

The Senate

Stillbirth Prevention Act up for UC?

We are hearing that the Senate could move by unanimous consent to pass H.R.4581, Maternal and Child Health Stillbirth Prevention Act of 2024. This bill would allow Maternal and Child Health Services Block Grant funds to be used for stillbirth research and prevention activities. Since this bill has already passed the House, the bill would go to the President’s desk if passed.

But this bill isn’t out of the woods yet. The UC process is dicey because a single senator can stop the process at any point. Senators have been known to block bills even if they agree with the underlying premise but have another issue (i.e. procedural concerns, concerns about related bills not getting a vote).

Health Care Hearings in the Senate

  • June 12: Senate Finance Committee hearing on youth residential treatment facilities
  • June 12: Senate Judiciary Committee hearing on youth vaping

The House

E&C Mark-Up Watch

What we are hearing: The House Energy and Commerce is expected to put out a notice of a mark-up on June 12 of several health care bills. These bills could be on a range of different topics, but we expect them to be non-controversial.

Just because these bills are non-controversial does not mean they are insignificant. Even bills that may not produce rage-inducing headlines can still involve significant appropriations in public health programs and major changes to the health care system. Plus, those non-controversial bills have the best shot of becoming law. Speaking of which…

Health Care Week? 

Just when we thought bipartisanship was dead, rumors of a bipartisan “health care week in the House” keep hopes alive. This rumored health care week would most likely occur in the second week of July and would be marked by votes on health care legislation. What bills would be included? Although we don’t know for sure, we bet that any bills coming out of that expected E&C markup would be prime contenders.

Now that we’ve talked about what might happen, here’s a look at the health care hearings in the House this week:

  • The show-stopper will be CMMI Director Liz Fowler on the hot seat at the June 13 House Energy and Commerce Health Subcommittee hearing on the CMS Innovation Center.  Director Fowler, a Hill alum, will try to defend the results-to-date of the evergreen funding the learning lab received from the ACA.
  • June 13: House VA Committee hearing on spinal cord injuries and disorders in the veteran community
  • June 13: House Budget Committee hearing on Medicare and Social Security

There You Have It

Flag Day is June 14! Check out these interesting facts about Flag Day. Let us know if you know any other fun facts about the Stars and Stripes. 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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