Health Policy Snapshot: September 2023

Greg Chesmore
September 05, 2023

Feds Release Top 10 Medicare Part D Drugs List; More Lawsuits Filed Against Inflation Reduction Act (IRA)

The Centers for Medicare & Medicaid Services (CMS) released its long-awaited list of the first 10 Medicare Part D drugs that will be subject to negotiation and potential price setting.  The move was heralded by President Joe Biden, congressional Democrats and some patient advocates, such as AARP.  Drugs included on the list include Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica and Stelara, as well as Fiasp and certain other insulins made by Novo Nordisk, including NovoLog. The medications treat heart disease, certain cancers, diabetes and autoimmune diseases, among other conditions. Medicare enrollees paid a total of $3.4 billion in out-of-pocket costs last year, according to the Department of Health and Human Services.  “Today is the start of a new deal for patients, where Big Pharma doesn’t just get a blank check at your expense and at the expense of the American people,” said President Biden. Meanwhile, PhRMA and some patient organizations cautioned that the move will ultimately negatively impact medical innovation and lead to fewer therapies and potential cures.  The Alliance for Aging Research said the announcement was “not a reason to celebrate”, citing its concern that government price setting will ultimately hurt patients.  Meanwhile, Congressional Republicans called the Biden Administration’s announcement an “egregious move that will destroy research and development”.  On the legal front, an eighth lawsuit against the IRA was filed by Astra Zeneca in Delaware.  Astra Zeneca joins PhRMA, the U.S. Chamber of Commerce, Merck, Bristol Myers Squibb, Janssen/J&J, Astellas and Boehringer Ingleheim who have each filed separate suits. Looking for additional resources from both sides of the debate? The Department of Health & Human Services released a one-page Drug Price Negotiation Fact Sheet on August 29, and here’s PhRMA’s latest (very concise) blog post on why the move is a bad idea.

…Meanwhile, Colorado’s Drug Affordability Board Selects Five Drugs to Review for Potential 2024 Price Limits

While the federal top 10 drug list generates headlines, Colorado’s Prescription Drug Affordability Board moved in August to potentially clamp down on five drugs, including the prospect of setting upper payment limits in 2024.  The drugs, which include Genvoya for HIV, Enbrel for rheumatoid arthritis, Cosentyx for psoriasis/psoriatic arthritis, Stelara for Crohn’s disease and Trikafta for cystic fibrosis, include two that are on the federal Medicare negotiation list (Stelara and Enbrel).  The Colorado board will now examine the price of each medication and determine whether or not the drugs are “unaffordable”, potentially limiting what state payers will pay for the products. The move has some rare disease advocates concerned, especially those living with cystic fibrosis.  When the state released the names of the five drugs in August, patient advocates flooded the state’s insurance commissioner with pleas to exclude drugs utilized to treat rare conditions. ““People are scared,” Colorado cystic fibrosis patient Sabrina Walker said. “If you look at all the drugs out there, it’s one that has been so transformational that I think it will go down in history for how positively it’s impacted our population as a whole.” State officials disagreed, accusing the pharmaceutical industry of attempting to unnecessarily scare. Meanwhile the National Association of State Health Policy (NASHP) predicted that given the federal attention on drug pricing in Medicare, the number of states considering legislation to establish Prescription Drug Affordability Boards (PDABs) will increase dramatically in 2024.  The nation’s toughest PDAB is expected to launch in Minnesota next year.

Democrats Increase Calls for Biden to “Get Tough” on State Medicaid Disenrollment

We’re up to an estimated 5.5 million Americans who have been disenrolled from Medicaid since the end of the COVID-19 Public Health Emergency in April. Some estimates claim more than 70% of those disenrolled were for “procedural reasons”.  Democratic members of Congress are pushing the Biden Administration to do more to pressure states to suspend disenrollment while issues are addressed. Some congressional leaders, including powerful Sen. Ron Wyden (D-OR) and Rep. Frank Pallone (D-NJ) have even encouraged the Administration to begin withholding Medicaid funding from states that they believe are moving too quickly (and potentially erroneously) on disenrollment.  Meanwhile, the ongoing drama surrounding disenrollment is spilling over to the political arena, with Democratic gubernatorial candidates and Democratic senators seeking re-election in states where legislators have chosen not to expand Medicaid (e.g. Mississippi and Wisconsin), calling for broad-based legislative and administrative action to protect those receiving Medicaid.  

2024 Republican Presidential Hopefuls and Health Care: What’s the Priority?

As the 2024 presidential campaign kicks into gear, the good folks at Politico have taken the time to spotlight some of the the Republican hopefuls’ health care priorities (a handful of which were recently mentioned during the first GOP primary debate in Milwaukee). To read the Politico piece, click here. Common themes (which aren’t a huge surprise): preservation of Medicare (but thinking more about long-term sustainability), more work requirements for Medicaid, expanding telehealth services and ensuring domestic production of essential medicines.  We can expect more details (or maybe not!) in the coming months.