Insights^

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

What Happened, What You Missed: June 12-16, 2023

Health Spending to Make Up One-Fifth of US Economy

National health expenditures will comprise 20% of the US economy, or $7.1 trillion, by 2031, according to the latest projections from the Centers for Medicare and Medicaid Services (CMS). While health care spending actually grew at a slower rate than the national gross domestic product (GDP) in 2021 and 2022, the latest figures project that health care spending will once again outpace GDP growth starting this year, due to the aging population and people seeking medical services that were delayed during the pandemic. CMS also found that the insured portion of the population reached a historic high of 92% in 2022, although that portion is expected to drop to 90.5% by 2031 due to people losing Medicaid coverage as the redetermination process resumes.

Biden Administration Reaches Deal to Preserve Preventative Services Coverage

The Biden administration finalized a deal with the 5th US Circuit Court of Appeals to preserve the federal mandate for health insurers to fully cover preventative care services like HIV prevention drugs and cancer screening. The agreement thus keeps in place the Affordable Care Act’s (ACA) preventative services coverage mandate while a lawsuit that challenges the mandate proceeds. Of note, the agreement allows the plaintiff in the case, Brainwood Management, to stop covering preventative services without co-payments for its employees. Brainwood and other plaintiffs are challenging the mandate because they believe it challenges their religious beliefs by supporting homosexuality and drug use. The Biden administration will continue to appeal the lawsuit.

Sanders Blocks Bertagnolli’s Nomination over Drug Pricing

Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) says he’ll oppose National Cancer Institute (NCI) Director Dr. Monica Bertagnolli’s nomination to lead the National Institutes of Health (NIH) until the Biden administration issues a plan to lower prescription drug prices. Sanders’ support is critical for Bertangnolli’s nomination to move forward, as he chairs the Senate panel responsible for confirming the nomination. In a statement, the White House pointed to the drug pricing provisions of the Inflation Reduction Act as a sign that the administration shares Sanders’ dedication to lowering drug costs without committing to releasing further plans. Meanwhile, organizations in the medical research community are urging Sanders and other key Senate Democrats to quickly confirm Bertagnolli to ensure the nation does not lose momentum on scientific research.

FDA Advisers Recommend Monovalent COVID-19 Boosters for Fall

Members of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously on Thursday to recommend that the 2023-2024 formula of the COVID-19 vaccines be updated to a monovalent XBB Omicron subvariant. According to the Centers for Disease Control and Prevention, XXB is responsible for nearly all COVID-19 cases in the US. The decision to go with a monovalent vaccine is a departure from the bivalent vaccines that included both the original strain of COVID-19 and the Omicron variant. The FDA advisers also opted to roll out the boosters in the fall to align with the availability of annual flu shots, despite a noted lack of certainty on the degree to which COVID-19 is seasonal.

ICYMI: Senators Celebrate Seeksucker Day

The Senate celebrated Seersucker Day last week as it has for years, with various senators and their staff donning seersucker suits. Senators took the occasion to the next level this year by approving a resolution from Sen. Bill Cassidy (R-LA) to make June 7 National Seeksucker Day, the month of June as National Seersucker Month, and every Thursday in June through August as Seersucker Thursday. Then-Sen. Trett Lott (R-MO) first introduced Seeksucker Day in 1996, and since Lott’s retirement, Cassidy has served as the “coordinator” of Seersucker Day.

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What Happened, What You Missed: June 5-9, 2023

Merck Sues HHS over Drug Pricing Law

Pharmaceutical company Merck filed a lawsuit on Wednesday against the Department of Health and Human Services (HHS) over Medicare’s plans to negotiate drug prices in the Inflation Reduction Act (IRA). According to the lawsuit, Merck says the IRA violates a Fifth Amendment clause that prohibits the government from taking private property for public use without proper compensation. The company also claims that the program violates the First Amendment by forcing them to convey that they agree with the negotiation process. The Biden administration has since expressed that it will win the lawsuit.

CDC: Blood Donations Show Widespread COVID-19 Immunity

Nearly all Americans had some level of COVID-19 immunity, according to a new study from the Centers for Disease Control and Prevention (CDC). The study looked at blood donations from people ages 16 years and older for COVID-19 antibodies from July through September 2022. CDC researchers found that 96% of blood donors had antibodies, with about 23% from infection alone and 26% from just vaccination. The remaining 48% had hybrid immunity from both infection and vaccination. The study found that vaccinated people had lower levels of infection, which points to the fact that vaccines still provide some level of protection against infection. The study also found that donors ages 65 and older were less likely to have hybrid immunity, which is probably due to the fact that seniors had earlier access to vaccines.

Charity Care Drops in Non-Profit Hospitals

Spending for charity care in non-profit hospitals has dropped despite higher profits, according to a new study in Health Affairs. While the mean operating profits for non-profit hospitals grew from $43 million in 2012 to $58.6 million by 2019, charity care spending dropped slightly during that time period, from $6.7 million to $6.4 million. Non-profit hospitals are required to provide charity care for their tax-exempt status. The study echoes previous analyses that found non-profit facilities spend less on charity care than for-profit facilities. Hospital groups contend that the community benefits that non-profit hospitals provide more than justify their tax-exempt status.

FDA First Rapid COVID-19 Test via Traditional Review Process

The Food and Drug Administration (FDA) approved on Tuesday the first rapid antigen, over-the-counter COVID-19 with the traditional premarket approval process, rather than through emergency use authorization (EUA). Manufactured by Cue Health, the test identified 93% of positive and 99% of negative samples in people with COVID-19, according to clinical trial data. The FDA says the authorization represents a new era of consumer access to COVID-19 tests. In a statement, a top FDA official said the authorization is part of a broader effort to expand the development and availability of over-the-counters tests for a variety of medical conditions.

ICYMI: UK PM Throws First Pitch at Nats Game

UK Prime Minister Rishi Sunak was the guest of honor at Nationals Park on Wednesday night as part of a trip to strengthen economic ties between his nation and the US. He threw the first pitch in a game that saw the Washington Nationals lose to the Arizona Diamondbacks 6-2. The following day, Sunak joined President Joe Biden at the White House to announce the Atlantic Declaration, a new framework for economic co-operation between the two nations. Biden and Sunak also discussed the importance of AI regulation.

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Senate Finance Committee Tackles Corporate Ownership in Health Care

On June 8, 2023, the Senate Finance Committee held a hearing to discuss consolidation and corporate ownership in health care.  Across the board, committee members were concerned about the large amount of vertical and horizontal consolidation in the healthcare market over the past 10 years.

CMS Proposes 340B Drug Payment Adjustment Rule

On July 7, 2023, the Centers for Medicare and Medicaid (CMS) issued the 340B Drug Payment Adjustment Proposed Rule.  The CMS fact sheet can be found here of the proposed rule. 

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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