Insights

The Doctor Isn’t In– What do retirements mean for health policy and physician payments?

 

A few weeks ago, we chronicled the challenge that the rise in mid-term resignations is posing for legislating in this Congress. While the recent spate of resignations has certainly posed a problem for the, still relatively new, speakership of Rep. Mike Johnson (R-LA), another challenge is looming for the House Republican Conference: the departure of some of its most respected health care voices.

In addition to the departure of House Energy & Commerce Chairwoman Cathy McMorris Rodgers, significant institutional and real-world health policy expertise will be heading for the exits as Rep. Larry Bucshon, MD (R-IN), Michael Burgess, MD (R-TX), Rep. Drew Ferguson, DMD (R-GA), and Rep. Brad Wenstrup, DPM (R-OH) have all decided to not seek reelection. Their four retirements mean the influential House GOP Doctors Caucus will not only be losing almost a quarter of its 19 members, but it also means that the Caucus will be losing 4 voices on the House’s two key committees for health policy—the House Ways and Means Committee and the House Energy and Commerce Committee.

It is hard to overstate the influence of these members as Burgess, Bucshon, and Wenstrup and the Caucus played an instrumental role in passing the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015, which finally repealed the sustainable growth rate formula and brought an end to the annual threat of drastic cuts in Medicare payments to physicians. While MACRA was no small feat, the victory has proven to be fleeting as physicians once again find themselves in an annual exercise of the threat of Medicare cuts. Each of the past four years, doctors have faced the threat of Medicare cuts, but only for 2021 did Congress provide full relief and now doctors are in the third straight year of Medicare payment cuts. While Congress did provide some relief in 2022, 2023, and 2024, the reality is that as costs are going up Medicare payments to physician have been declining.

 

There is general agreement something must be done. Last year, Congress finally held hearings to look at the Medicare payment challenges facing physicians once again. Yet, while it took Congress almost a decade before holding its first MACRA oversight hearing, some have been trying to make up for lost time as the House Energy & Commerce Health Subcommittee heard testimony regarding the Provider Reimbursement Stability Act (H.R. 6371), which was introduced by fellow doctor, Rep. Greg Murphy, MD (R-NC), and would enact the first sizable payment reforms since MACRA, and then approved the legislation in November of last year.

 

Among its reforms, the legislation would help address the threat of annual Medicare payment cuts by updating the “budget neutrality” threshold that can trigger potential cuts when certain services see a change in valuation or when new codes are introduced to the Medicare physician fee schedule.

 

While the outlook for significant health legislation before the election seems grim, the legislation has bipartisan backing and the support of the House GOP Doctors Caucus behind it, and one must wonder if H.R. 6371 might be these scions’ legislative swan song. For four members who have contributed so much to health policy over the last decade, it would only be fitting if they left one last indelible mark on Medicare before heading for the exits.

If you would like to connect with Chamber Hill Strategies, please do not hesitate to contact us. 

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To Legislate or Regulate? That is the question as Congress Reviews the FDA Proposed Rule to Regulate LDTs As Medical Devices

Washington generally moves in one of two ways; either Congress legislates, or the Administration regulates. However, these two paths converge often as our system runs on checks and balances. Federal agencies produce regulations, and Congress conducts oversight of those agencies. The Food and Drug Administration’s (FDA) proposed rule to regulate lab developed tests (LDTs) as medical devices came about in response to a perceived failure to legislate, and Congress is responding by exercising its oversight authority. This blog provides a history of the development of this rule and where things stand in its implementation. 

How We Got Here 

Efforts to address concerns about certain LDTs came to a head with the publication of the FDA’s 2014 draft guidance outlining a risk-based approach to regulating moderate and high-risk LDTs as medical devices. Early discussion drafts of what ultimately became the Verifying Accurate Leading-edge IVCT Development (VALID) Act started making the rounds among representatives in 2015 in response to the draft guidance.  The House Energy and Commerce Health Subcommittee responded with a hearing in November of that year on the subject of diagnostic testing and laboratory operations. Prior to the hearing, the Energy and Commerce Committee circulated draft legislation that removed LDTs from FDA’s medical device authority,  relocated them under a new center within the agency, and prioritized avoidance of duplicative regulation with CMS, among other provisions. However, a lack of stakeholder consensus around the Energy and Commerce approach formed. Other legislative proposals, including from former Senate Health, Education, Labor and Pensions Chair Lamar Alexander (R-TN), continued to be floated by stakeholders but none ever gained traction. Ultimately, the Trump Administration’s FDA announced in January of 2017 that they would not finalize the draft guidance – one of several Obama-era regulations to fall to the new Administration’s unprecedented use of the Congressional Review Act (CRA). 

 

Bipartisan congressional interest in enhanced oversight of LDTs continued despite the rollback of the guidance. Moreover, FDA leadership publicly affirmed that a legislative solution would be the preferred mechanism for future regulation of in vitro diagnostics (IVDs). Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) released the discussion draft Diagnostic Accuracy and Innovation Act (DAIA) in March of 2017. This legislation had the elements of the framework developed by the Diagnostic Test Working Group (DTWG) – an independent group consisting of representatives from diagnostic manufacturers and clinical laboratories – with further input from additional stakeholders. Reps. Bucshon (R-IN) and DeGette (D-CO) intended to evoke responses from the FDA and public and professional stakeholders by publishing this document. Significant backlash ensued, given its higher regulatory burden and likely inhibiting effect on innovation.  Reps. DeGette (D-CO) and Bucshon (R-IN) released A new version of the DAIA draft, entitled VALID, in 2018 It also gained the support of former Senator Orrin Hatch (R-UT) and Senator Michael Bennet (D-CO).  However, many stakeholders, including the American Clinical Laboratory Association (ACLA), remained opposed to the early version of VALID because it took a more device-centric model toward regulating IVDs.  

 

Still stakeholders continued to work to improve the bill. Stakeholders identified creation of a diagnostic regulatory framework, risk classification, and grandfathering of existing tests as top priorities. By the Spring of 2022, VALID legislation included all of these priorities and others.  Despite this, key stakeholders, including ACLA, College of American Pathologists (CAP), and the Association for Molecular Pathology (AMP), refused to endorse it.  

 

Efforts to pass VALID continued to fail given the lack of stakeholder support despite bipartisan, bicameral support. A push to include it as part of the FDA User Fee Reauthorization Act failed.  Senator Richard Burr (R-NC), who replaced Sen. Hatch  as the lead Republican VALID sponsor, pushed hard for inclusion of the bill in the end of year spending bill, the Consolidated Appropriations Act of 2023. However, this effort failed as well, despite it being a top priority for the retiring Burr because of opposition from academic medical centers (AMCs) interested in a regulatory carveout for their reference lab businesses. 

 

Where We Are 

Many believe that Burr’s failure to get VALID included in the end of year package in 2022 served as the catalyst for the FDA deciding to publish its proposed rule to regulate LDTs as medical devices in October of 2023. The rule proposes to phase out its default posture of enforcement discretion for IVDs in five stages over 4 years. The proposed rule is as bad, from a test developer standpoint, as it can be. It layers medical device regulation over the practice of laboratory medicine including pre-market review requirements; there is no risk classification and all IVDs default to high risk; there is no grandfathering of existing tests; and test modifications require premarket submission.  FDA received over 6500 comments on the rule, the vast majority of which are negative. The agency plans to finalize the rule in April according to their unified agenda. FDA is unlikely to make significant changes before finalizing the rule and will face litigation challenging their authority to issue it as soon as they finalize.   

 

Stakeholders concerned with the rule immediately started reaching back out to policymakers urging Congress to pass a legislative alternative. The House Energy and Commerce Health Subcommittee held a hearing on the rule, its impact on patient access and the appropriate role for FDA on regulating them.  They heard from five stakeholders, all of which expressed a preference for legislation and either endorsed VALID or spoke positively about VALID. ACLA, CAP, AdvaMedDx, Friends of Cancer Research, and a pathologist from the University of Colorado (CO), who is also a cancer survivor, testified. All, except ACLA and the CO pathologist, fully endorsed VALID and ACLA acknowledged that they worked hard on developing VALID and would far prefer that to a finalized FDA rule. Moreover, all Republican Subcommittee members and several Democrats, including Health Subcommittee Ranking Member Anna Eshoo (D-CA) – a cosponsor of VALID — expressed concerns with FDA’s medical device approach and a preference for VALID or a similar legislative alternative.  

 

Where We Are Going  

The hearing provided a great first step toward passage of VALID or another version of it (maybe even with a different name?).  The Energy and Commerce Committee demands that any legislation over which it has jurisdiction must submit to regular order before being considered by the full House. The sponsors of VALID can now argue that their bill has undergone a legislative hearing., However, the legislation faces challenges. VALID still has bipartisan congressional support in the House but, with Sen. Burr’s retirement, it no longer enjoys such support in the Senate. Stakeholders, and most notably AMCs, can no longer be fragmented in their support if, as we suspect, they prefer legislation to FDA medical device regulation. Once the FDA proposed rule to regulate LDTs as medical devices goes final, we believe even those who are still pursuing Clinical Laboratory Improvement Amendments (CLIA) modernization as the only alternative – a non-starter with policymakers – may come around to VALID.  

 

If you would like to connect with Chamber Hill Strategies, please do not hesitate to contact us. 

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Bucking the Leadership: Tracking Congressional Departures

Rep. Ken Buck (R-CO) announced his plans to resign from Congress on March 22 rather than stick it out through the rest of his term.   While it wasn’t an earthquake that upset the balance of power, the announcement certainly sent tremors pointing to the increasingly challenging environment facing Speaker of the House Mike Johnson (R-LA) and Republican congressional leaders. Rep. Buck joins several other House GOP members on the list of resignations that have occurred this year. In conversations with the press, Buck hinted other similar retirements of House Republicans might be following. The current House Republican majority sits at 219 members to 213 for House Democrats. With Buck’s departure, that margin will shrink to 218-213. The margin will likely shrink to 218-214 when New Yorkers go to the polls on April 30 to select a replacement, likely a Democrat, for the recently retired Rep. Brian Higgins (D-NY).  

Hope for Bipartisanship  

All of these resignations and retirements from Congress come with numerous political and policy ramifications.  Beyond the spectacle of it all, the narrow margins and volatility, combined with a divided Congress, mean that now more than ever, there is a need for bipartisanship to find policy solutions that can actually become law. Congress recently showed that bipartisanship is not dead in Washington D.C. and one area where we are seeing it occur is in health care policy. Congress (narrowly) avoided a government shutdown with an appropriations bill that included a “skinny” health care package. This package included an increase to partially address Medicare physician reimbursement rate cuts and reauthorizations for several health care programs. Some stakeholders expressed disappointment in what was not included in the legislation, such as reforms to address concerns about the practices of pharmacy benefit managers (PBMs). However, this bill showed signs that partisans in Congress still share some priorities in the health care space.  A March 12 Energy and Commerce Markup of 19 bipartisan health care bills also provides  hope for moving bipartisan health legislation addressing a range of issues such as  maternal health, mental health, dementia care, cancer screenings, and more. Adding additional cause for hope were comments from Rep. Larry Bucshon, MD (R-IN), expressing a positive outlook for bipartisan legislation to address nagging issues facing physicians under Medicare.  

What this Means for Stakeholders Looking for Action 

The recent resignations and retirements from Congress make it unlikely we will see the “big health care stuff” passed before the election. However, the weeks and months ahead will be crucial in laying the groundwork for additional health care legislation, including possible payment reforms, PBM reforms, the addressing of varying reimbursement rates for hospitals, and providing for the mental health needs of physicians. If you have a priority health issue, the time is now for stakeholders to get their message out to lawmakers and congressional staff. If you have a such an issue and need to navigate both sides of the aisle, please feel free to reach out to our team; we would be happy to talk about how we can help. 

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Bucking the Leadership: Tracking Congressional Departures

AI is Taking Over the Capital

In the ever-evolving landscape of technological advancement, the discourse surrounding artificial intelligence (AI) regulation has quickly emerged as the focal point of the global conversation. The unprecedented summit between President Joe Biden and President Xi Jinping added a new chapter to this narrative, igniting discussions that transcend borders and underscore the critical importance of shaping the future of AI. The two leaders agreed that using AI in nuclear or other military operations creates many risks, however, the senior U.S. official said neither was ready for any mutual declaration banning the use.  

The Senate also showed concern regarding AI innovation on a global scale. Earlier this month, they held a hearing on how the U.S. can influence allies and non-allies to ensure that the development of AI systems globally doesn’t empower digital authoritarianism. A worry for the committee was how to handle Chinese innovation in AI technology; Witness Nathaniel Fick from the Department of State explained that the best way to hinder Chinese innovation is to continue to foster innovation among allies at home and abroad. Fick refers to President Joe Biden’s Voluntary Commitments as an example of partnerships at home fostering innovation. 

However, the Senate isn’t just interested in AI’s effect on foreign affairs; the Senate Health, Education, Labor, and Pensions Committee (HELP) and the Homeland Security Committee held hearings on domestic concerns regarding AI. The Senate HELP Committee focused on AI’s positive and negative impact on the healthcare system as a whole. Members discussed three bills addressing the negative positive impacts of AI in healthcare:  the Artificial Intelligence & Biosecurity Risk Assessment Act; the Securing Gene Synthesis Act; and a new bill from Sen. Mike Braun (R-IN), the Medicare Transaction Fraud Prevention Act. (The final bill is aimed at preventing the elderly population from being victims of fraud.)  

The Committee on Homeland Security met to discuss the Philosophy of AI and as interesting as it sounds, the Senators indicated that the hearing was to explore what action(s) should be taken rather than introducing solutions. The witnesses included various professors and their testimonies urged the Senate to pass laws that regulate AI rather than letting AI dictate the regulations. An interesting point brought up during this hearing was by Prof. Daron Acemoğlu, he claims that even though he doesn’t believe that AI will/does automate white-collar jobs, it will most likely automate the IT and IT security jobs. 

Lastly, going back to Biden’s Voluntary Commitments from Leading Artificial Intelligence Companies to Manage the Risks Posed by AI, it very much just reads like a pact of promises that may or may not do anything, we will have to see some time pass before we have a definitive answer on their viability. Nonetheless, it’s good to see that AI is on the list of priorities for the Administration. 

This isn’t the end for AI on the Hill either, even just this week there is a House Energy and Commerce, Health Subcommittee hearing on Understanding How AI is Changing Health Care. Now even though AI is taking over the Capital, you can count on us listening and watching with our own human, eyes and ears. 

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What Happened, What You Missed: November 13-17, 2023

Congress Averts Shutdown with “Laddered” CR 

Congress averted a government shutdown days ahead of a November 17 deadline through enactment of a 2-part “laddered” CR this week.  Originally conceived by the House Freedom Caucus and introduced by Speaker Mike Johnson (R-LA), the laddered CR addresses House Republicans’ concerns of voting for another large omnibus funding bill all at once by creating a January 19 deadline for 4 appropriations bills for Fiscal Year (FY) 2024 and a February 2 deadline for the 8 remaining FY 2024 spending bills.  While Democratic lawmakers initially panned the idea of a laddered CR, the measure went on to earn widespread support from Democrats over an eagerness to avoid a shutdown ahead of a busy Thanksgiving travel season, as well as a lack of viable alternatives.  However, the CR’s passage does not meaningfully advance the debate on FY 2024 spending levels, and gridlock on appropriations is expected to continue through the holiday season.  

CDC: Childhood Cancer Deaths Dropped 24% in Last 20 Years 

The rate of pediatric cancer deaths in the US declined 24% between 2001 and 2021, according to new data released by the Centers for Disease Control and Prevention (CDC).  The fall in cancer deaths can largely be attributed to advances in the treatment of childhood cancer, namely leukemia.  However, the CDC data found noteworthy racial and ethnic disparities on pediatric cancer mortality.  While the cancer death rate for all children declined at the same level between 2001 and 2011, Black and Hispanic children saw only a minor drop in cancer death rates between 2011 and 2021.  Public health experts say the financial burden on families with children undergoing cancer treatment as well as limited access to high-quality pediatric cancer treatments like gene therapies may be to blame for these disparities. 

Longest-Serving Physician in Congress to Retire 

Rep. Michael Burgess (D-TX) announced Monday he will not be seeking reelection in 2024.  First elected to Congress in 2022, the obstetrician-turned-lawmaker is the longest-serving physician in Congress, and he currently serves as co-chair of the House GOP Doctors Caucus.  A longtime Republican voice on health care issues, Burgess chaired the Health Subcommittee of the House Energy and Commerce Committee from 2017 to 2019 and served as the subcommittee’s top Republican from 2019 to 2021.  A stalwart critic of the Affordable Care Act (ACA), Burgess played a key role in advancing legislation to overhaul the way physicians are reimbursed by Medicare in 2015. 

White House Announces New Women’s Health Initiative 

President Joe Biden launched the White House Initiative on Women’s Health Research on Monday to address a long-standing lack of funding women’s health research and revolutionize how the federal government approaches the topic.  To be led by First Lady Jill Biden, the initiative plans to deliver recommendations within 45 days on ways the Biden administration can improve how research into women’s health is conducted and identify opportunity for additional investment.  While funding for the National Institutes of Health (NIH) has grown for the past 8 consecutive years, only 10.8% of funding is spent on women’s health.  Additionally, while conditions like heart disease, multiple sclerosis, and Alzheimer’s disproportionately affect women, most of the research and testing around these conditions focus on men.    

ICMYI: DC Teased with Possible Panda Return 

Chinese President Xi Jinping hinted in a speech this week that panda could return to Washington, DC when he noted a desire to “continue our cooperation” panda conservation.  Xi’s remarks came following a meeting with President Joe Biden in San Francisco amid rocky relations between the two powers.  The news sparked hope in Washington, DC area residents who have been mourning the recent departure of pandas from the National Zoo, who have since arrived in China. 

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What Happened, What You Missed: October 23-27, 2023

New Speaker Outlines Plan to Wrap Up FY24 Appropriations Process

In a letter to House Republicans, newly elected Speaker Mike Johnson (R-LA) outlined a plan to extend government funding in the likely scenario that Congress fails to reach a deal before the current November 17 deadline., Johnson proposed a continuing resolution to January 15 or April 15, 2024 in order prevent members from succumbing to pressure to agree to a what Republicans may perceive as a less-than-ideal Fiscal Year (FY) 2024 omnibus before Congress leaves for its holiday season break.  Johnson also laid out a schedule for the House to pass its 8 remaining FY 2024 appropriations bills before November 17.

Survey: 51% Working-Age Adults Struggle to Afford Health Care 

Just over half of working-age Americans across all insurance types have trouble affording health care costs, according to a survey from the Commonwealth Foundation.  Types of coverage surveyed include employer sponsored plans, individual and marketplace coverage, Medicare, and Medicaid.  Additionally, the survey found that more that 50% of respondents who delayed care due to costs said a health problem became worse as a result.  The survey found nearly one-third of Americans have medical or dental debt that they are paying off over time, with 85% owing more than $500.  To address health care affordability, the report suggests lowering health care cost growth and adjusting premiums based on employee income.

Biden Asks Congress for More Money to Fight Fentanyl

The White House requested $1.55 billion from Congress this week to address fentanyl overdose deaths as part of a broader package to address domestic priorities like child care, nutrition assistance, and national security.  The funds would be included with grants the administration currently gives to states, territories, and tribes to support overdose prevention services, bolster addiction recovery, and improve addiction treatment.  The administration also requested funding for 1,000 additional Customs and Border Protection officers to focus on counter-fentanyl trafficking activities.  According to the Centers for Disease Control and Prevention (CDC), 150 people die every day from overdoses related to synthetic opioids like fentanyl.

HELP Committee Advances Bertagnolli Nomination over Sanders’ Objection

National Cancer Institute (NCI) Director Monica Bertagnolli, MD is one step closer to becoming the first permanent National Institutes of Health (NIH) director in nearly 2 years after the Senate Health, Education, Labor, and Pensions (HELP) Committee voted 16-5 to advance her nomination on October 25.  Chairman Bernie Sanders (I-VT) was the sole member of the majority to oppose Bertagnolli’s nomination due to her unwillingness to support the use of march-in rights to address high prescription drug costs.  Sanders’ vote against Bertagnolli has not been his only criticism of NIH – just two days before the committee vote, he alleged that NIH leadership had violated the Bayh-Dole Act by awarding an exclusive patent license for an NIH-funded cancer therapy to a company connected to a former NIH employee.

ICYMI: Bowman Faces the Music for Fire Alarm Shenanigans

Rep. Jamaal Bowman (D-NY) plead guilty this week for the misdemeanor charge of improperly pulling a fire alarm in a congressional office building.  According to a deal with the DC Office of the Attorney General, Bowman’s charges will be dropped in 3 months if he submits a formal apology and pays a $1,000 fine.  Typically, one misdemeanor count of a false fire alarm could be punishable by up to 6 months in prison and a $1,000 fine in DC.  Bowman says he pulled the fire alarm because he was trying to unlock a door in order to vote in time.

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What Happened, What You Missed: September 18-22, 2023

House GOP Momentum on CR Comes to a Halt

House Republican leadership scrapped a plan earlier this week to hold a procedural vote on a continuing resolution (CR) to fund the government after September 30 due to lingering opposition from hardline conservatives. Speaker Kevin McCarthy (R-CA) modified plans for a 30-day CR by capping Fiscal Year (FY) 2024 spending levels at $1.47 trillion and adding some border security measures as a means to win over Freedom Caucus members who were initially opposed to a stopgap funding measure. However, nine House Republicans declined to support the new CR proposal, which boosts the odds of a shutdown at the end of the month. Even if McCarthy’s stopgap appropriations agreement had succeeded in the House, his CR would have likely been dead on arrival in the Senate, which has taken a more bipartisan approach to FY 2024 spending.

Administration Revives Free COVID-19 Test Program

The Biden administration is bringing back a program that will allow Americans to order free COVID-19 tests ahead of a possible winter surge in cases. Starting on September 25, every US household can order four free COVID-19 rapid tests on COVIDtests.gov to be delivered directly to their home. According to the administration, the tests are able to detect the latest variants and are intended to be used through the end of 2024. To ensure the availability of tests, the administration is also providing $600 million to 12 manufacturers to produce 200 million tests. For the past three years, COVID-19 cases have peaked in January.

KFF: Most Nursing Homes Don’t Meet Proposed Staffing Requirements

Very few nursing homes in the US meet staffing requirements as proposed by the Biden administration, according to a survey from the Kaiser Family Foundation (KFF). The survey found that less than 20% of nursing facilities would meet the proposed staffing requirements at any time, although results varied across states. While all nursing facilities in Alaska would be able to meet the proposed requirements, only 1% of facilities in Louisiana would meet them. The recently proposed requirements call for facilities to have a minimum of 0.55 registered nurse (RN) and 2.45 nurse aide hours per resident day, as well as require facilities to have an RN on staff 24 hours per day, 7 days per week.

Poll: Americans Want More Controls on Opioids

Voters from both parties broadly agree on increasing control of opioids like fentanyl by enacting stronger border controls and punishing drug dealers, according to a Morning Consult poll. However, there were partisan differences with how to address the opioid crisis, with Republicans opposing harm reduction strategies like syringe services that Democrats tend to support. The poll also found that voters tend to see the opioid crisis more as a security issue than a health issue, which benefits Republican candidates who are perceived as stronger on security than Democrats. Voters who live in border states like Arizona, California, New Mexico and Texas were more likely to label the opioid epidemic as a security issue, according to the poll.

ICYMI: Senate Drops Enforcement of Dress Code

The US Senate will no longer enforce its dress code for senators, according to a recent announcement from Majority Leader Chuck Schumer (D-NY). The change was primarily made to accommodate Sen. John Fetterman (D-PA), who prefers to wear hooded sweatshirts and shorts. Senators from both parties and the Washington Post editorial board were quick to condemn the change, noting that it could lead to a slippery slope where lawmakers would eventually wear sports team apparel and clothing with inflammatory political statements on the Senate floor. However, the dress code will continue to be enforced for Senate staff.

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

Odds of Shutdown Grow as Appropriations Gridlock Continues

The White House is urging Congress to agree to a short-term continuing resolution (CR) to keep the federal government open after the current fiscal year (FY) ends on September 30. To date, only the House has advanced an appropriations bill for FY 2024, although the Senate is considering moving forward on a package of spending bills as soon as next week. However, with little time remaining for a bipartisan, bicameral FY 2024 spending agreement, the Senate appears to be signaling that the upper chamber will address the looming appropriations deadline with a bipartisan CR of their own. However, widespread disagreements over spending among Republicans in the GOP-controlled House make the path forward on a bicameral CR increasingly tenuous, which raises the odds for a government shutdown in just over three weeks.

Health Affairs: 32% of HHS Appointees Leave for Private Industry

About one in three political appointees at the Department of Health and Human Services move on to positions in the private industry, according to a study published in Health Affairs. The study examined HHS appointee exits across three presidential administrations from 2004 to 2020. While Republicans were more likely to appoint individuals to HHS from industry than Democrats, political appointees from both parties departed for industry jobs at similar rates. The study’s authors noted that the 32% does represent the true extent of transitions to the private sector, as some non-profit roles support commercial interests. According to the study, appointees’ departures to industry shouldn’t be surprising given higher compensation in the private sector.

Moderna: New COVID-19 Vaccine Effective against BA.2.86

Moderna’s new COVID-19 vaccine that’s set to become available this fall offers a strong immune response to the BA.2.86 Omicron subvariant, according to data published by the company. Moderna’s new vaccine was initially developed to target XBB.1.5, which was the most prevalent Omicron subvariant in early 2023. BA.2.86 has 34 to 36 different mutations in the spike protein compared with XBB.1.5, which has sparked concerns that the new subvariant could evade protection from new vaccines. Fortunately, according to Moderna, its new shot induces aan 8.7-fold increase in neutralizing antibodies against BA.2.86. Additionally, a trio of studies introduced in the past week suggest that BA.2.86 is not as infectious as previous subvariants.

New CMS Model Aims to Address Chronic Diseases

The Centers for Medicare and Medicaid Services (CMS) launched the States Advancing All-Payer Health Equity Approaches and Development Model (AHEAD) Model on Tuesday, which aims to partner with states to address chronic disease, behavioral health, and other medical conditions. Participating states will work with CMS to redesign health care delivery to improve the total by improving the quality and efficacy of care delivery and reducing health disparities. The AHEAD Model hopes to incentivize better health outcomes by providing hospitals with a prospective payment stream via hospital global budgets. The model also intends to boost coordination across payers, providers, and community organizations in participating states. A Notice of Funding Opportunity (NOFO) will be released in late fall 2023.

ICYMI: Most Americans Want Age Cap for President

Some 76% of Americans say there should be a limit for how old someone can be to serve as president, according to a poll from The Economist/YouGov. The poll comes amid growing questions about the age and health of US politicians. For example, 81-year-old Senate Republican Leader Mitch McConnell (R-KY) recently froze up at a press conference, while 90-year-old Sen. Dianne Feinstein (D-CA) did not appear in the Senate for several months due to shingles and other health issues.

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What Happened, What You Missed: May 29-June 2, 2023

Debt Ceiling Deal Takes Back “Some” Unspent COVID Funds

The debt ceiling agreement, passed this week in the House by a 314-117 bipartisan vote, includes the withdrawal of $30 billion in unspent COVID-19 relief funds, which was a top priority for Republican negotiators. However, funding for two COVID-19 programs will remain untouched: an initiative to provide free COVID-19 vaccines to the uninsured, and a project to develop the next generation of COVID-19 vaccines and treatments. According to the Biden administration, some of the unspent money can be used to offset cuts to nondefense spending. The bill would also prevent steep cuts to health care programs in the Labor, Health and Human Services, Education and Related Agencies appropriations bill by keeping nondefense discretionary spending levels nearly flat for Fiscal Year (FY) 2024 and allowing a 1% increase for FY 2025.

KFF: 600K Have Lost Medicaid Coverage since April 1

Over 600,000 Americans have lost Medicaid coverage since the beginning of April, according to a new analysis from the Kaiser Family Foundation (KFF). April 1 marked the earliest date that states could begin to terminate Medicaid enrollment for individuals no longer eligible. According to KFF, the overwhelming majority of people who lost coverage in most states were dropped because of technicalities, not because state Medicaid offices determined they no longer meet Medicaid income limits. Some of the technicalities that result in disenrollment include a failure to complete the enrollment process. The large jump in disenrollments is stoking fears that the end of continuous Medicaid enrollment could mean a significant number of enrollees will eventually lose coverage. Before April 1, KFF estimated that over a quarter of Americans, or 93 million, had coverage under Medicaid or the Children’s Health Insurance Program (CHIP).

CMS Announces Limited Coverage Plan for Alzheimer’s Drugs

The Centers for Medicare and Medicaid Services (CMS) announced that Medicare will eventually cover a new class of Alzheimer’s drugs in specific cases, but only after the Food and Drug Administration grants traditional approval. According to the announcement, Medicare will cover the drugs when a physician and clinical team participate in the collection of evidence about how these drugs work in the real world, known as a registry. Under current CMS policy, Medicare only covers the drugs if the patient is participating in a clinical trial. Known as Leqembi and Aduhelm, these new Alzheimer’s disease treatments work by targeting amyloid plaques in the brain, which is associated with a slower progression of memory loss. However, these treatments have been marred with controversy for the past few years, both for their high price tag, mixed results on efficacy, and side effects related to brain bleeding and swelling.

Study Finds Similar Patient Outcomes Between MDs and Dos

There are no major differences between medical doctors (MDs) and doctors of osteopathy (DOs) when it comes to patient experience and clinical outcomes, according to a study recently published in the Annals of Internal Medicine. Of the nearly 330,000 Medicare admissions analyzed in the study, patient mortality rates for MDs and ODs were nearly identical at around 9.5%, while hospital readmission rates for both stood at just under 16%. Additionally, the length of stay for both MDs and ODs was 4.5 days. While DOs and MDs must both follow a lengthy education process, DOs focus on a more holistic or whole-person approach to care delivery, while MDs focus on diagnosing and treating medical conditions.

ICYMI: National Zoo Welcomes First Baby Gorilla in 5 Years

Lucky visitors to the Smithsonian National Zoological Park this summer might get a chance to see the zoo’s first baby gorilla in five years. The infant, who was born late last week, is a critically endangered lowland gorilla. The Great Ape House space in the zoo provides its gorilla residents access to private space, so visitors may not be able to always see the youngest member of the zoo’s lowland gorilla family.

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What Happened, What You Missed: January 23-27

Rep. Guthrie to Chair Health Subcommittee

Rep. Brett Guthrie will chair the House Energy and Commerce Subcommittee on Health in the 118th Congress. Guthrie first became the Health Subcommittee’s top Republican at the start of the 117th Congress in January 2021, replacing Rep. Michael Burgess (R-TX), who sought to become the top Republican on the full Energy and Commerce Committee.  As chair of the Health Subcommittee, Guthrie’s likely priorities will be price transparency, the fentanyl epidemic, telehealth, medical product innovation, and exploring the business practices of pharmacy benefit managers (PBMs).  The Health Subcommittee will hold its inaugural hearing of the new Congress on February 1 to review legislation to address the fentanyl crisis.

Bivalent Boosters Cut Risk of Infection by Half

The new bivalent COVID-19 booster reduces the risk of symptomatic infection of the dominant Omicron XBB/XBB.1.5 subvariants by about 48%, according to new data from the Centers for Disease Control and Prevention (CDC).  Considered the most transmissible subvariant to date, XBB.1.5 is currently responsible for 49% of new COVID-19 infections nationwide.  The study found that the bivalent boosters were slightly more effective in preventing symptomatic infection in adults ages 18 to 49 than adults ages 50 and older.  However, most Americans are not benefitting from the added protection of a bivalent booster, as only about 15% of eligible Americans have received the new booster.

HHS: Insulin Price Caps Mean Savings for Seniors

1.5 million seniors in the US could save up to $500 per person annually thanks to new insulin price caps, according to a new report from the Department of Health and Human Services (HHS).  The report analyzed the impact of the $35 monthly insulin price cap in the Inflation Reduction Act, which went into effect for Medicare Part D beneficiaries on January 1, 2023.  According to the report, the average out-of-pocket cost per insulin fill for Part D beneficiaries in 2019 was $58 per insulin fill, while people with private insurance or Medicare coverage paid about $63 per fill.  The report also found that Medicare beneficiaries in Texas, California, Florida, North Dakota, Iowa, and South Dakota are likely to incur the most annual savings at $700-$800 per person.

JAMA: Telehealth Didn’t Help with Opioid Treatment

There was no significant difference in outcomes between people who sought treatment for opioid use disorder via telehealth or in-person via a clinician, according to a new study from the Journal of the American Medical Association (JAMA).  Since the start of the COVID-19 pandemic, emergency waivers have allowed people struggling with opioid addition to virtually receive prescriptions for treatments like buprenorphine.  One of the reasons why telehealth may not have resulted in better outcomes for substance use disorder patients is the limited access to broadband internet, particularly in low-income or rural communities.

ICYMI: Diversity Lags among Congressional Staff

While the 118th Congress is the most diverse in history, diversity amongst congressional staff is still playing catch-up, according to a report from the Joint Center for Political and Economic Studies.  The report found that only 18% of top congressional staffers are people of color, compared to 40% of Americans nationwide.  However, the report did note some recent areas of improvement, such as the fact that top staff working for returning members of Congress are more diverse than ever before.  Some of the obstacles preventing people of color from working in Congress include relatively low pay rates and the Washington, DC area’s high housing costs.

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