legislation & regulation

On Sept. 19, the Biden administration filed a petition asking the U.S. Supreme Court to review the case Braidwood Management, Inc. v. Becerra, which challenges the legality of the Affordable Care Act’s requirement that nearly all health insurers must cover a slew of preventive services without cost sharing.

Legal experts tell AIS Health, a division of MMIT, that the case could have significant ramifications for patients and the health care industry alike. And they say how it plays out may partly depend on who wins the upcoming elections.

“We’re getting close to four years in terms of when it was filed, but the stakes of this case remain really significant for tens of millions of Americans,” says Zachary Baron, director of the Health Policy and the Law Initiative at the O'Neill Institute. More than 150 million Americans have benefited from no-cost coverage of preventive services, he says, including lung cancer screenings, statins used to lower cholesterol, mammograms, vaccines and birth control.

Enhanced Affordable Care Act subsidies reduce out-of-pocket premiums mostly for adults ages 50 and older and for those living in states where monthly premiums for ACA marketplace plans are high, according to a recent Urban Institute study.

Enhanced advance premium tax credits (APTCs) were initially implemented as part of the 2021 American Rescue Plan Act and extended through 2025 by the Inflation Reduction Act. They offer more generous subsidies than were available under the original ACA rules for people with incomes at or below 400% of the federal poverty level (FPL), which for 2024 are $60,240 for an individual and $81,761 for a couple. Additionally, the enhanced APTCs limit premium contributions to 8.5% of income for marketplace enrollees with incomes above 400% of FPL.

With five weeks to go until election day, the vice presidential candidates sparred over health care during their Oct. 1 debate. There were no new revelations, but the Affordable Care Act was top of mind for both Minnesota Gov. Tim Walz (D) and Sen. JD Vance (R-Ohio), despite some industry observers’ belief that Republicans might want the candidates to steer clear of any major reforms.

Vance briefly touched on his idea to move higher-risk people into separate risk pools in the individual market and allow states to “experiment a little bit” on coverage for healthier people and those with pre-existing conditions. Vance claimed protections for pre-existing conditions would remain in place but that he would also try to “make the health insurance marketplace function a little bit better.”

Medicare Advantage plans are set to receive at least $11.8 billion in quality bonus payments in 2024, according to a recent analysis by the Kaiser Family Foundation (KFF). This figure represents an 8% decline from the $12.8 billion awarded in 2023, a reduction that was not surprising given the expiration of pandemic-era policies that temporarily boosted Star Ratings for some plans. But with rising cut points and looming program changes such as the Health Equity Index (HEI) replacing the current reward factor, payers may struggle to improve their Star Ratings — and thus boost bonus payments — moving forward.

Although the November elections may alter the balance of power in Congress and change which party controls the White House, Democratic lawmakers this week introduced legislation that would advance a key policy priority for Affordable Care Act supporters and health insurers alike: Making enhanced ACA subsidies permanent.

One health policy expert says the timing of the move makes sense, despite the imminent elections.

“It’s good to kind of get the bill on the table and get people talking about the issue,” says Katherine Hempstead, Ph.D., senior policy adviser at the Robert Wood Johnson Foundation. She also tells AIS Health, a division of MMIT, that it’s important to “raise the profile of…how there will be chaotic [rate] filing next year if there’s uncertainty about whether the tax credits are going to be there or not.”

Across the U.S., UnitedHealthcare’s negotiated commercial rates with hospitals for hip and knee replacements last year ranged from $11,203 to $106,427, according to a Sept. 20 analysis published in JAMA Health Forum. Meanwhile, the same study found that the negotiated rates for hip and knee replacements in the Chicago area varied significantly by hospital and payer.

Allison Oakes, Ph.D., the study’s lead author, tells AIS Health the variation was “staggering” and “inexcusable” and occurred even as insurers are subject to the Transparency in Coverage (TiC) rule that went into effect in 2022.

Sen. Bernie Sanders (I-Vt.) said during a Senate hearing that major PBMs promised to expand access to Ozempic and Wegovy if Novo Nordisk agrees to lower the list price. In a tense hearing on Sept. 24 held by the Senate Health, Education, Labor and Pensions Committee, Sanders, the committee chair, sought answers from Novo CEO Lars Jorgenson as to why the company’s semaglutide list prices top $1,000 a month in the U.S., noting that the drugs can cost anywhere from $130 to even $59 in other countries. Ozempic and Wegovy, both GLP-1 drugs, treat Type 2 diabetes and obesity, respectively. Sanders challenged Jorgenson to lower the U.S. list price, noting that The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx pledged to expand coverage of the diabetes and obesity medications. Jorgenson did not commit to a price reduction, saying “I don’t know under which conditions such a promise comes,” but he seemed to remain open to the idea if it helps patients access more affordable medicine. Jorgenson also noted that the $1,000 drug list price is a starting point for payer negotiations and said the company pays 75 cents per dollar received due to discounts, fees and rebates.

Health policy experts appear to largely agree that regardless of the partisan makeup of Congress and the White House next year, PBM reform will continue to be a key priority. Opinions are mixed, however, as to whether Democrats or Republicans would be more likely to take the hardest line against a highly scrutinized industry.

During a recent webinar hosted by Faegre Drinker Consulting, Nick Manetto, a principal at the firm, said Democrats are “maybe a hair” more likely to embrace PBM reforms that go beyond enacting new transparency requirements. PBM critics have said that while they support transparency, more data-reporting requirements aren’t enough to drive meaningful change in the industry.

Lobbying spending by the health care industry has increased steadily over the past decade, reaching $129.3 million in 2023, according to data compiled by OpenSecrets. Among the major health plans and industry organizations, Blue Cross Blue Shield plans, AHIP, The Cigna Group and UnitedHealth Group spent the most during the 2023-2024 period, with BCBS plans spending more than $43 million from 2023 through the second quarter of 2024.

Since 2016, the health services/HMOs industry, which traditionally gives more to Republicans, has shifted to distribute more campaign funds to Democratic lawmakers. With the 2024 presidential election around the corner, around 57.3% of funds were donated to Democrats in the 2023-2024 election cycle. Among the top 20 lawmakers who received the most contributions from the industry during this election cycle, 11 are Democrats. Kamala Harris, who is running for president after President Joe Biden dropped out and endorsed her, topped the list and received over $2,347,000. Former President Donald Trump, the Republican presidential nominee, received $638,421.

Over the last few years, the FDA has taken multiple steps to level the playing field between biosimilars and interchangeable biosimilars. More recently, it proposed draft guidance that would do away with switching studies for interchangeability status. Commenters on that guidance were mostly supportive — with some even backing interchangeability for all biosimilars — and others asked for clarification on a range of issues, including what information the FDA needed to make a determination of interchangeability. Meanwhile, one group derided the guidance as an “ill-advised and inappropriate move.”