Medicare’s drug negotiation program will be in court today

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Today’s edition: Two senators strike a deal on legislation aimed at improving primary care, but not everyone is happy. Planned Parenthood will resume offering abortions in Wisconsin after pausing the service for more than a year. But first … 

One of President Biden’s main health-care wins will be under fire today

Medicare’s drug negotiation program is going to court.

Today marks the first oral arguments in a major legal battle over whether one of President Biden’s signature legislative achievements will be scrapped. Drug industry giants and other corporate foes have filed a flurry of lawsuits in an attempt to block the federal government’s ability to negotiate the price of certain prescription drugs. 

But only one group — the U.S. Chamber of Commerce — asked for a preliminary injunction to prevent its members from starting the negotiation process while litigation on the merits of the case continues. The influential business lobby wants a federal judge in the Southern District of Ohio to issue a ruling before Oct. 1.

That date was picked for a reason. Oct. 1 is the deadline for companies manufacturing drugs the federal government selected for the first round of negotiation to decide whether to sign agreements to participate in the negotiation process.  

The new program is the result of a rare loss on Capitol Hill for the pharmaceutical industry lobbying machine. Last year, Democrats passed legislation allowing the federal health insurance program to negotiate the price of drugs for the first time — and the legal blitz by opponents amounts to a list-ditch effort to thwart the program. Biden is expected to promote the popular policy on the campaign trail, though the majority of Americans say they aren’t aware of Medicare’s new powers. 

Judge Michael J. Newman, a Trump nominee, will hear oral arguments in the case at 2 p.m. 

Jeffrey S. Bucholtz, of King & Spalding, will argue on behalf of the U.S. Chamber. Brian Netter, a deputy assistant attorney general, will serve as the litigator for the Biden administration. 

About the case: Court documents and interviews give a good snapshot of what to expect in today’s hearing. The U.S. Chamber, along with local groups, filed its lawsuit in June arguing the drug negotiation program was unconstitutional for multiple reasons. A month later, the business lobby filed a motion for a preliminary injunction that relied solely on one claim: the Fifth Amendment’s due process rights. 

• “The heart of our due process claim is that when the government engages in price setting, there have to be sufficient procedures to protect businesses … from basically having their property taken at less than its fair value,” Jennifer Dickey, deputy chief counsel of the U.S. Chamber Litigation Center, said in an interview. 
• The lawsuit names AbbVie — whose blood cancer medication was chosen for the first round of drug negotiation — as a member of the U.S. Chamber. Dickey confirmed other members were also selected for the program but declined to say how many, saying the group’s membership was “confidential.”

On the other side: The federal government revealed how it plans to play defense in an August motion opposing the preliminary injunction. For one, the plaintiffs don’t have standing to sue, the Justice Department argued, while also contending that participation in the program is voluntary.

• “Like every other pricing structure in Medicare, the Negotiation Program thus does not compel manufacturers to surrender their property — at any price,” attorneys for the federal government wrote. The DOJ declined to comment further.

The Biden administration released the list of the first 10 high-cost drugs subject to negotiation late last month, with the lower prices of the medicines taking effect Jan. 1, 2026. More than half of the drugs selected are aimed at preventing blood clots and treating diabetes. 

Eight lawsuits had been filed even before the list came out. Since then, Novartis has sued the Biden administration over the inclusion of its heart failure drug Entresto. One company — Astellas Pharma — dropped its lawsuit after its prostate cancer drug Xtandi ultimately wasn’t chosen. 

Some of the lawsuits hinge on arguments that the rules force drugmakers to agree to a price the federal health department sets and thus violates their free speech rights. Many also allege the program flouts the Fifth Amendments requirement that the government pay “just compensation” when taking private property.

This week, we got our first glimpse at how the government will attempt to defend against those claims. A DOJ legal filing in a case brought by Merck again argued the program was voluntary and “neither compels Merck to surrender its property in violation of the Fifth Amendment nor requires it to engage in speech in violation of the First.”

Sanders, Marshall announce agreement on primary care legislation

After weeks of negotiations, Senate HELP Committee Chair Bernie Sanders (I-Vt.) and Sen. Roger Marshall (R-Kan.) struck a deal on legislation to infuse federal programs with billions of dollars to expand access to primary care and reduce provider shortages.

The bill includes $5.8 billion annually over the next three years to fund community health centers, one of several authorizations set to expire Sept. 30. The package also allocates additional funding for health-care workforce training initiatives, scholarships and debt forgiveness programs. The panel is slated to markup the package next Thursday. 

• To pay for the legislation, Sanders plans to use $3 billion in savings to the federal government from a separate bill his committee passed earlier this year to reform pharmacy middlemen and increase access to generic drugs. The bill would also tap nearly $1 billion from a fund created in the Affordable Care Act to bolster the nation’s public health system, per Stat’s Rachel Cohrs. 

Yes, but: While Sanders clinched the deal with Marshall, Sen. Bill Cassidy (La.), the health panel’s ranking Republican, criticized the deal. We’re watching to see if he uses his leverage as the panel’s top GOP lawmaker to seek changes to the legislation, which he called “unfinished and haphazardly drafted” in a statement yesterday. 

Sen. Bernie Sanders (I-Vt.): 

It is unacceptable that millions of Americans do not have access to affordable, high-quality primary care. I am LIVE on the Senate Floor with Senator @RogerMarshallMD as we announce a bipartisan bill to address this crisis. https://t.co/S5kqHVTKrN

— Bernie Sanders (@SenSanders) September 14, 2023

Key House Republicans are threatening to subpoena officials at the Department of Health and Human Services and other Biden administration players if the agency fails to comply with their requests for information on the origins of covid-19 by Sept. 21. 

In a letter sent yesterday to HHS Secretary Xavier Becerra, the GOP lawmakers accused the agency of stonewalling their requests since they launched their pandemic probes earlier this year. HHS did not immediately respond to The Health 202’s request for comment. 

• The Republicans who signed onto the letter include Energy and Commerce Committee Chair Cathy McMorris Rodgers (Wash.); Oversight and Accountability Committee Chair James Comer (Ky.); Rep. Brad Wenstrup (Ohio), the chair of the House select subcommittee on the coronavirus pandemic; and several others.

The House select subcommittee on the coronavirus pandemic:

A House bill designed to increase health-care price transparency and extend funding for key health programs would save the federal government $800 million over the next decade if signed into law, according to an estimate from the Congressional Budget Office. 

Planned Parenthood to resume abortions in Wisconsin

Planned Parenthood will restart abortion services in Wisconsin next week more than a year after clinics stopped performing the procedure, our colleagues Patrick Marley and Caroline Kitchener report. 

Pregnant patients will be able to obtain abortions at Planned Parenthood’s clinics in Milwaukee and Madison starting Monday. Another clinic in Sheboygan, Wis., will not resume abortions; the district attorney in Sheboygan County is a Republican who has said he would enforce the ban.

Key context: Planned Parenthood and others stopped providing abortions in Wisconsin after the Supreme Court overturned Roe v. Wade because of an 1849 state law that was broadly viewed as banning nearly all abortions. The state’s Democratic attorney general sued to overturn the law last year. In July, a judge issued an initial ruling that concluded the measure doesn’t ban women from seeking abortions, but instead bars someone from battering a pregnant woman and killing the fetus. 

• The judge is expected to issue a final ruling in the case soon, but the lawsuit will likely wind up before Wisconsin’s newly liberal-leaning Supreme Court.

Planned Parenthood Advocates of Wisconsin:

BREAKING: Planned Parenthood of Wisconsin will resume abortion care services on Monday, September 18th at the Water Street Health Center in Milwaukee, and the Madison East Health Center. pic.twitter.com/rNT1fx4THY

— Planned Parenthood Advocates of Wisconsin (@PPAWI) September 14, 2023

In other news from across the country …

In Nevada: A coalition of abortion rights groups filed a petition yesterday seeking to place a question on the 2024 ballot to enshrine abortion protections into the state constitution. The potential ballot measure would allow the state to prohibit abortions after fetal viability, except when the mother’s life or physical or mental health is at risk. 

In Texas: Lawmakers in Mason and Chandler County failed to pass proposals this week to enact new ordinances that would have made it illegal to transport anyone to get an abortion on roads within their  jurisdiction. The measure is a new strategy designed by the architects of the state’s roughly six-week ban that took effect before Roe fell. But even in some of the most conservative corners of Texas, those efforts are meeting some resistance, as our colleague Caroline Kitchener recently reported.

In South Carolina: Abortion providers filed a legal challenge yesterday asking the state Supreme Court to clarify the window of time in which they can legally terminate a pregnancy under a new law that the panel recently upheld, which bans abortion after fetal cardiac activity is detected often at six weeks of pregnancy.

Philadelphia bans safe-injection sites in most of the city

Philadelphia’s city council voted yesterday to largely ban facilities where people can consume illegal substances under the watch of workers trained to reverse overdoses, delivering a blow to advocates who say the sites can help curb the toll of the nation’s drug crisis, our colleague David Ovalle reports. 

The 13-1 vote underscores broader tension over the concept of such facilities, which have been slow to garner support in U.S. cities because of concerns that they flout federal law and fears that they encourage drug use and crime.

The bigger picture: The council’s decision could stymie a long-held plan by the nonprofit Safehouse to open an overdose prevention center in the city, which drew a legal challenge from the Justice Department under former president Donald Trump in 2019. Subsequent litigation between Safehouse and the federal government over the site is ongoing. 

• Safehouse will continue pressing its case in the courts and still hopes to open a facility in Philadelphia despite the city council’s decision, Ronda Goldfein, the organization’s vice president, told David.

The abortion bot will see you now (By Tatum Hunter l The Washington Post)

First, the loss of a baby, then the loss of legal rights (By Ian Shapira | The Washington Post)

Opponents of COVID restrictions took over a Michigan county. They want deep cuts to health funding (By Joey Cappelletti | The Associated Press)

“Where Is There to Go?” He Needs Gender-Affirming Surgery, but His State Is Fighting to Deny Coverage. (By Aliyya Swaby | ProPublica)

Thanks for reading! See y’all Monday.

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