Insights^

Find our analysis on legislation, regulations, MedPAC meetings, and more. 

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!

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.  

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. (ndu.edu.ng) 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. 

What Happened, What You Missed: December 4-December 8, 2023

White House Proposes Using March-In Rights to Lower Drug Costs 

The Biden administration proposed guidance on Thursday outlining factors that federal agencies should consider in determining whether to use march-in rights to seize the patents of certain expensive drugs.  Codified in the Bayh-Dole Act of 1980, march-in authority allows the government to take over patents for drugs developed with taxpayer funds and share them with other drug companies if the public cannot reasonably access the drug.  However, no federal agency to date has ever invoked march-in rights to break a patent over a drug’s high price.  The announcement comes as President Biden plans to make lowering drug costs a key pillar of his health care platform for his 2024 reelection campaign.   

Biden Administration Delays Ban on Menthol Cigarettes to 2024 

A ban on menthol cigarettes that was originally schedule to take effect in December 2023 won’t happen until at least March 2024, according to the White House Office of Information and Regulatory Affairs (OIRA).  While the Biden administration has so far declined to comment on the delay, the decision is likely due to lobbying from the tobacco industry, which has been fighting a similar ban in California.  News of the delay has left anti-tobacco advocates devastated due to the public health impact of menthol cigarettes.  The Food and Drug Administration (FDA) estimates that a ban on menthol cigarettes could prevent 300,000 to 650,000 smoking deaths over 40 years.  Most of these preventable deaths are attributed to Black Americans, who smoke menthol cigarettes at higher rates. 

Bipartisan Senators Seek Answers on Impact of Private Equity 

Senate Budget Committee Chairman Sheldon Whitehouse (D-RI) and Ranking Member Chuck Grassley (R-IA) sent letters on Thursday to seven companies in an effort to learn more about the impact of private equity on the health care industry.  The letters include questions on financial relationships and whether private equity companies can determine business practices like staffing ratios, billing, and key personnel decisions.   The senators’ inquiry reflects a growing scrutiny over the role of private equity in medicine, which critics say has been attributed to higher health care costs and utilization as well as lower-quality care.  However, proponents of private equity contend that these firms play an important role in the health care industry by enabling growth and increasing the market power of smaller health care entities. 

McCarthy, McHenry Announce Exits from Congress 

This week, former Speaker Kevin McCarthy (R-CA) and former Speaker Pro Tempore Patrick McHenry (R-NC) announced that they will not seek reelection to Congress in 2024.  The announcements cap off a chaotic year in the House, where McHenry served as acting speaker for most of October 2023 following his close ally McCarthy’s historic ouster from the speakership.  Known for his fundraising prowess, McCarthy will officially leave Congress at the end of 2023, although he has vowed to remain active in politics by working to recruit the next generation of Republican leaders.  In contrast, McHenry will stay on until his term ends in January 3, 2025, which will surely be followed by a competitive race to determine who will be the next top Republican on the House Financial Services Committee.   

ICYMI: Holiday Decorating Contest in Congress Draws Controversy 

Launched in 2019, an annual holiday decorating contest for lawmakers’ offices on Capitol Hill has been largely a friendly affair.  However, this year’s contest has ruffled a few feathers for being overly political.  Rep. Eli Crane (R-AZ) has faced criticism from Democrats for his border security-themed decorations that feature a “Border Patrol Elves Only” sign on an office door, while the office of Mike Collins (R-GA) has a cardboard cutout that references Hunter Biden’s drug use.  Fortunately, the majority of other members of Congress has taken a less political approach by choosing themes like local sports teams and Star Wars for their decorations. 

What Happened, What You Missed: November 27-December 1, 2023

Biden Invokes DPA to Address Drug Shortages

On Monday, President Joe Biden invoked the Defense Production Act (DPA) during an inaugural meeting of the Council on Supply Chain Resilience to ease drug shortages.  The announcement comes amid shortages of penicillin, Adderall, and certain cancer drugs that have affected doctors and patients across the nation.  The administration plans to use the DPA to invest $35 million to support domestic manufacturing of essential medicines and key ingredients.  Additionally, the White House will appoint a new Supply Chain Resilience and Shortage Coordinator to focus on long-term supply chain issues, and the Defense of Defense (DOD) will release a report on pharmaceutical supply chain resilience.

US Life Expectancy Sees Post-COVID Bump

The US life expectancy rate rose for the first time since the COVID-19 pandemic began, according to data from the Center for Disease Control and Prevention (CDC).  Researchers found a 1.1-year increase in 2022, bringing the overall life expectancy to 77.5 years.  This marks a reversal of the 2.4-year life expectancy drop that occurred over 2020-2021, which was largely driven by COVID-19 deaths.  Native Americans saw the largest life expectancy increase of 2.6 years, while the life expectancy gap between White and Black Americans narrowed slightly in 2022.  However, CDC researchers did note a rise in deaths from flu, pneumonia, kidney disease, and fetal and infant conditions in 2022.  The CDC also found that deaths from suicide reached a record high of nearly 50,000 in 2022.

Lawmakers Explore Use of AI in Health Care

Members of the House Energy and Commerce Health Subcommittee heard from health care industry stakeholders in a hearing on Wednesday about the potential for artificial intelligence (AI) to decrease administrative burden and improve care delivery.  However, witnesses warned that regulations will be needed to protect patients’ privacy and ensure that AI does not discriminate against patients.  While subcommittee members were particularly interested in the ways AI could address clinician burnout as well as workforce shortages, there has yet to be any significant momentum on legislation to address AI in health care settings.

Califf Taps New Principal Deputy Director for FDA

FDA Chief Scientist Namandjé Bumpus will succeed Janet Woodcock as the agency’s Principal Deputy Director, according to an announcement from FDA Commissioner Robert Califf.  Earlier this month, Woodcock announced that she will be stepping down from her role in early 2024, marking the end of a 37-year career at FDA that included stints as action commissioner as well as head of the agency’s Center for Biologics Evaluation and Research (CBER).  Bumpus’ priorities in her new role include the creation of a new model for the office charge of inspecting facilities that manufacture drugs and medical devices.  Prior to joining the FDA in August 2022, Bumpus chaired the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine, where she conducted research on drug metabolism and the effects of antivirals on humans and pathogens.

ICYMI: High Winds Take Down White House Christmas Tree

The White House Christmas Tree was a casualty to 46 mph winds that befell the National Capital Region on Tuesday, just two weeks after the tree had been planted at the White House Ellipse.  The incident caused 20 ornaments to fall from the tree, although none of the ornaments were damaged.  Fortunately, the tree was raised just hours later, allowing the White House Christmas Tree lighting ceremony to continue as planned.

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