The Week Ahead

Stay informed with our weekly buzz about what’s going on in Washington, DC.

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) statswork.com) ” href=”https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpolicycrush.us4.list-manage.com%2Ftrack%2Fclick%3Fu%3D376b597042727023b90a0d75c%26id%3D3092f83419%26e%3D765e242272&data=05%7C02%7Ctashi%40chamberhill.com%7Cba03d0c431624a3a346a08dc89575ef8%7C88aa046a655e4b09a66d2b5a1e19609a%7C0%7C0%7C638536255571213166%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=7JYtVGlbFjTM17Yx6T%2B0kTSOQV2SiPKFQOAoqjXJvmM%3D&reserved=0″ target=”_blank” rel=”noopener noreferrer” data-auth=”Verified” data-linkindex=”0″>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!

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!

The Medicare and SS Trustees Reports – Where Do Things Stand?

The 2024 Reports from the Medicare Trustees and the Social Security Trustees are here.  Let’s dig in to learn where things stand on the perennial question of insolvency and their recommendations. 

The 2024 Medicare Trustees Report showed a positive trend for the Hospital trust fund (Part A), with 5 more years of solvency added.  This moves out the point at which all benefits could be paid at current levels from 2031 to 2036. 

The improvement was due to lower than expected Medicare trust fund expenditures for 2023 (especially for inpatient hospital and home health services), higher payroll tax income, and “a policy change correcting for the way medical education expenses are accounted for in Medicare Advantage rates starting in 2024.”  

In other words, they changed the way the assumptions were calculated.   

The trustees noted 3 factors related to the pandemic: 

  1. Beneficiaries who died from COVID-19 were the sickest with more comorbidities.  Now, the remaining Medicare population is “healthier” as a percentage which leads to lower overall projected spending.  
  1. The expiration of the waiver requiring a 3-day inpatient stay to receive SNF services. Trustees assume that the 3-day inpatient stay requirement will now remain in place, which will increase inpatient spending by 1.9 percentage points and decrease SNF spending growth by 7.5 percentage points in 2024.      
  1. Lower than normal home health spending.  Due to staffing shortages in 2023, home health expenditures were still lower than expected.  But Trustees believe that demand will increase in 2024, and are projecting an increase in the home health spending growth factor by 2.9 percentage points for the next 3 years (2024-2026).   

By contrast, the Social Security Trustees noted a neutral trend from last year.  For Social Security, insolvency is coming in 9 years (CY 2033), which is the same projection as last year.  Funding was projected to decrease due to declining fertility rates but was projected to increase due to increased labor productivity.  So, the two factors equalized the other out.   

Medicare and Social Security Trustees said that Congress and the White House need to act now to be able to create solutions that can be more flexible and gradual.    If the can continues to be kicked down the road, cuts will have to be harsher and more immediate.  Trustees also recommended that Congress and the White House work together to come up with solutions.   

So, is this the year that Congress and the administration address Medicare and Social Security insolvency?  It looks unlikely.  When Speaker Johnson (R-LA) took leadership in January, he announced he would create a bipartisan fiscal commission to address the national debt and necessity of spending cuts.  But news agencies have already reported the Commission is DOA.  Sponsors of a bill to create such a commission in both the House and Senate have said that they have no support to move the bills forward.  A commission faces bipartisan disapproval, with Democrats concerned a commission would cut benefits like Social Security and Medicare and Republicans concerned a commission would be a vehicle for tax increases.    

So, the deadline towards insolvency once again looms, without a path to address it…. 
 

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!

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!