Missouri

Drugmakers sue to block Missouri law on federal prescription discounts • Missouri Independent

Published

3 months ago

August 27, 2024

Drugmakers sue to block Missouri law on federal prescription discounts • Missouri Independent

Three major pharmaceutical companies and their national lobbying organization are suing Missouri to block enforcement of a new state law requiring them to give medical providers unlimited access to discounted drugs for their pharmacies.

In four federal lawsuits filed over the past month, Novartis, AstraZeneca, Abbvie and PhRMA, the lobbying arm of the pharmaceutical industry, argue that Missouri lawmakers unconstitutionally intruded into interstate commerce with the bill passed this year.

Under the bill, drugmakers must accept orders to deliver medications to providers eligible for discounts under the 340B program, named for the section of law where it is authorized. The bill allows eligible providers to have an unlimited number of contracts with pharmacies to dispense their prescriptions of drugs purchased under the program.

“Under the Supremacy Clause of the United States Constitution, Missouri has no authority to define who has access to 340B-priced drugs,” states the lawsuit filed last week by PhRMA in the Western District of Missouri.

The law takes effect on Wednesday. The plaintiffs in each case have asked for a preliminary injunction to block enforcement, but no hearings on the requests have been scheduled and only one case, filed Aug. 2 by Novartis, has had enough activity for the judge to schedule any proceedings.

Abbvie went first, filing its lawsuit July 22 in the Eastern District — 10 days after Gov. Mike Parson declined to sign the bill and instead allowed it to become law despite his misgivings. The other three cases are filed with the Western District, which includes Jefferson City.

The lawsuits name Attorney General Andrew Bailey and members of the state Board of Pharmacy, which is responsible for enforcing the law. The board is given authority to investigate violations of the law and the attorney general has enforcement powers through the state Merchandising Practices Act.

“It is difficult to convincingly argue that doing what a federal program requires is an irreparable harm,” Maria Lanahan, deputy solicitor general in the attorney general’s office, wrote in a filing arguing against a preliminary injunction in the Novartis lawsuit. “To the contrary, when Novartis complies with S.B. 751, it is helping covered entities that serve vulnerable populations.”

Bailey’s office did not respond to an email seeking comment on the cases.

The board is relying on Bailey to respond to the lawsuit. The law is self-enforcing and while the board could write rules about how it is to be followed, Executive Director Kimberly Brinston said.

“The board does not have a timeline to promulgate rules and has not made a decision on whether rules would be promulgated,” she said.

The Missouri Hospital Association and the Missouri Primary Care Association have asked to intervene in the Novartis lawsuit and will likely seek to join the other three, hospital association spokesman Dave Dillon said Monday.

“We are evaluating each case and intend to reinforce the work done by the General Assembly on behalf of Missouri’s hospitals, other providers and the communities they serve,” Dillon said.

The 340B program was created in 1992. It had two components — drug manufacturers had to deliver their products at a discount to eligible providers and eligible providers could only use the program to provide prescriptions to patients they treated directly.

Eligible providers included children’s hospitals, as well as hospitals that were sole providers in their community or designated “critical access hospitals” by providing care that would otherwise be absent, and those serving large numbers of indigent patients known as “disproportionate share hospitals.”

Other qualifying providers include federally qualified health care centers — clinics that receive grants to support operations so they can base charges on ability to pay — as well as clinics that serve AIDS patients, black lung victims and other debilitating diseases.

The use of contract pharmacies started in 1996, when the U.S. Department of Health and Human Services began allowing one contractor per provider as recognition that many providers did not have in-house pharmacies. But a change to allow unlimited contracting increased the number of contract pharmacies from 2,321 in 2010 to 205,340 in 2024, according to data from PhRMA provided to The Independent in June.

Nationally, pharmaceutical manufacturers sold nearly $100 billion in discounted drugs in 2021 and 2022. Discounts averaged 60% from regular wholesale prices, the lobbying organization stated.

The pharmaceutical companies focus their criticism on the disproportionate share hospitals, who often contract with for-profit pharmacies to dispense the drugs. Those hospitals account for about 80% of all drugs purchased through the 340B program, $41.8 billion in 2022 and $34.3 billion the year before.

Pharmaceutical companies complain that the discounts are rarely passed on to patients. Instead, insurance companies and consumers pay retail prices and the extra profit is often split between the pharmacy and the provider.

“Make no mistake, the boom in contract pharmacies has been fueled by the prospect of outsized profit margins on 340B-discounted drugs,” AstraZeneca’s lawyers wrote in the complaint filed last week. “In short, the widespread proliferation of contract pharmacy arrangements since 2010 has transformed the 340B program from one intended to assist vulnerable patients into a multi-billion-dollar arbitrage scheme.”

The drugmakers have fought the expansion of contract pharmacies in a variety of ways. When Novartis sought in 2020 to limit the contracts to pharmacies within 40 miles of an eligible provider, the U.S. Department of Health and Human Services issued a notice that it considered the limit a violation of the program’s rules.

An advisory opinion on contracting, later withdrawn, said the 340B program required delivery to a pharmacy on “the lunar surface, low-earth orbit, or a neighborhood…”

The 3rd U.S. Circuit Court of Appeals in Pennsylvania ruled in January 2023 in a case against the federal agency that pharmaceutical companies could impose limits on the number of pharmacies they would allow to purchase the discounted drugs.

After the 2023 ruling, Novartis tightened its rules to allow only one contracted pharmacy per covered provider, but only if the provider did not have an in-house pharmacy. Other manufacturers have imposed variations on the Novartis policies.

State efforts to counter the limits have ramped up in the past two years. Missouri is one of eight states to pass laws requiring drugmakers to deliver discounted medications to contract pharmacies.

Arkansas was one of the first. In March, the 8th Circuit Court of Appeals in St. Louis upheld the Arkansas law requiring drugmakers to allow covered providers to have an unlimited number of contract pharmacies.

In the motion to dismiss the Novartis lawsuit, the Missouri attorney general’s office relied heavily on that ruling, writing that it shows federal law does not prevent Missouri from passing a similar law.

The four lawsuits use a variety of legal theories to assail Missouri’s new law. Along with allegations of interfering with interstate commerce and regulating in an area reserved for federal action, the Abbvie lawsuit argues that its property rights are being violated.

“These abuses of the federal 340B program raise obvious concerns because the U.S. Constitution prohibits the government from forcing the transfer of property at confiscatory prices to private parties for their own private benefit,” the lawsuit states.

In the filing seeking to intervene in the Novartis case, the hospitals and primary care associations argued that the revenue from profits on 340B medications are essential support for their operations.

“Reducing access to those savings,” the filing states, “means hospitals are unable to underwrite critical but under-reimbursed services lines.”

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Nonprofit drops $150K into PAC supporting lame-duck Missouri governor • Missouri Independent

Published

7 hours ago

November 21, 2024

Press Room

Nonprofit drops 0K into PAC supporting lame-duck Missouri governor • Missouri Independent

The not-for-profit group originally set up to pay for Gov. Mike Parson’s 2021 inauguration gave $150,000 this week to the political action committee that helped get him elected.

Parson is leaving office due to term limits and has said repeatedly that he does not intend to be a candidate for public office again.

The PAC, Uniting Missouri, received the donation on Monday from Moving Missouri Forward Inc., which also paid the expenses to write and publish a biography of Parson called “No Turnin’ Back” that the governor has promoted extensively since its publication in February.

The origin of the $150,000 is unclear, since Moving Missouri Forward is not required to disclose its donors. But none of the money donated Monday was generated by sales of the Parson book, attorney Marc Ellinger said in an interview with The Independent. A different not-for-profit called Moving Missouri Forward Foundation receives all proceeds from book sales, he said, and is headed by First Lady Teresa Parson as president and Claudia Kehoe, wife Gov.-elect Mike Kehoe, as vice president.

“It paid for the book and contributed the entire cost of it and everything to the foundation as a charitable contribution, so that the foundation would have an ability to raise money through the book,” Ellinger said.

Ellinger is the registered agent for both Moving Missouri Forward Inc. and Moving Missouri Forward Foundation.

Uniting Missouri PAC had about $93,000 on hand at the end of October. Reports filed with the Missouri Ethics Commission show it raised about $1.3 million since the start of 2023 and spent about $775,000 this year helping two officeholders Parson appointed, Kehoe and Attorney General Andrew Bailey, win hotly contested Republican primaries.

Uniting Missouri has also spent about $120,000 for Parson’s trips to watch the Kansas City Chiefs win the two most recent Super Bowls.

Tom Burcham — a former Republican state lawmaker from Farmington with close ties to Parson’s longtime friend and fundraiser, lobbyist Steve Tilley — is in charge of Uniting Missouri. It is unclear why the PAC needs to keep raising money to support a candidate who is no longer running for public office, and Burcham did not respond to a request for comment.

Burcham is also the registered agent for a not-for-profit created in September called 57 Foundation Inc., in reference to Parson’s position as the 57th governor of the state. The nonprofit held a fundraiser Nov. 14 in Kansas City where donors paid as much as $10,000 for a table and pre-event reception with the Parsons.

The purpose of 57 Foundation, according to its incorporation papers, includes “providing essential resources and support to needful and vulnerable Missourians who cannot adequately help themselves. The foundation’s activities are inspired by and aligned with the legacy of public service and contributions of Missouri’s 57th Governor, Michael L. Parson.”

The Moving Missouri Forward Inc. donation to Uniting Missouri is roughly equal to the remaining funds raised on behalf of Parson, Ellinger said.

It will now transition to become a vehicle for funding Kehoe’s inauguration, he said.

Soon after Parson’s 2021 inauguration, Moving Missouri Forward Inc. released a list of donors who contributed $500 or more to the $369,115 raised for the festivities. The list did not include the specific amounts donated.

As a not-for-profit 501(c)(4) entity, it is not required to reveal its donors. It is required to file a statement of revenues and expenses annually with the IRS. The most recent report, filed in November 2023 and covering 2022, shows $3,000 in contributions in 2022 and $40,563 in cash on hand at the end of the year.

The filing also showed a $25,000 contribution to the Moving Missouri Forward Foundation. The foundation is a 501(c)(3) entity and contributions are tax deductible.

The purpose of the Moving Missouri Forward Foundation, according to its creation filing, is to “aid, assist, or help Missouri’s children, including but not limited to Jobs for America’s Graduates-Missouri and children with autism and special needs.”

Mike and Teresa Parson have been co-chairs of Jobs for America’s Graduates-Missouri since 2016, when he was elected lieutenant governor.

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Mississippi State football injury report vs Missouri: Who’s in, who’s out in Week 13

Published

15 hours ago

November 21, 2024

Press Room

Mississippi State football injury report vs Missouri: Who’s in, who’s out in Week 13

STARKVILLE — Mississippi State football is coming off its open week with no new injuries.

The Bulldogs’ injury report for Week 13 did not show any additions from their most recent SEC injury report, in Week 11 against Tennessee. MSU (2-8, 0-6 SEC) hosts Missouri (7-3, 3-3) at Davis Wade Stadium on Saturday (3:15 p.m. CT, SEC Network) in the final home game of the season.

The Tigers listed starting quarterback Brady Cook as probable after he returned from an injury last week.

The SEC newly mandated this season that each team provides injury reports for conference games. The first reports are revealed on Wednesdays and updated daily until the final report 90 minutes before kickoff. The full report is below.

Mississippi State football injury report vs Missouri

This will be updated daily as the injury reports change.

Mississippi State

QB Blake Shapen: Out
CB Traveon Wright: Out
WR Creed Whittemore: Out
WR Trent Hudson: Out
RB Keyvone Lee: Out
DL Kalvin Dinkins: Out
DL Kedrick Bingley-Jones: Out
OL Canon Boone: Out

Missouri

WR Mookie Cooper: Out
DE Darris Smith: Out
QB Sam Horn: Out
LB Khalil Jacobs: Out
DE Joe Moore: Out
OL Connor Tollison: Out
S Tre’Vez Johnson: Probable
QB Brady Cook: Probable

Sam Sklar is the Mississippi State beat reporter for the Clarion Ledger. Email him at ssklar@gannett.com and follow him on X @sklarsam_.

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Oklahoma Still ‘Believes’ in QB Jackson Arnold After Tough Missouri Outing

Published

23 hours ago

November 20, 2024

Press Room

Oklahoma Still ‘Believes’ in QB Jackson Arnold After Tough Missouri Outing

NORMAN — The bye week was Oklahoma’s final chance to reset before ending the year with the gauntlet of Alabama and LSU in consecutive weeks.

To have a chance to pull off an upset either in Norman on Saturday night or in Baton Rouge after Thanksgiving, the Sooners will need much better play from their quarterback.

Jackson Arnold fumbled three times in OU’s loss to Missouri, losing two of them including the game-ending scoop-and-score, which was just the latest hiccup in the quarterback’s year-long turnover issues.

And while the offense has plenty of problems across the board, from the lack of explosive plays to protection issues by the offensive line, Oklahoma (5-5, 1-5 SEC) coach Brent Venables said the process to keep Arnold confident after another batch of back-breaking turnovers is still ongoing on the practice field.

“I think it’s gonna be the same type of experience it’s gonna be for the rest of his career and he’s no different than any other player other than he’s the face,” Venables said on Tuesday. “That goes along with that position at a place like the University of Oklahoma. That’s a position that’s a little bit … it’s a bit like the head coach position. There’s a different type of microscope and there’s a different type of focus and that’s okay he’s got broad shoulders to handle that.

“… Improving and developing, making mistakes, learning from the good and the bad… that’s just a daily task. He’s got a huge part in that experience and the development and the improving and taking ownership. You can’t deflect it. You have to have great awareness, you have to have great self-awareness and you’ve got to have great humility and then you have to have respect for what I need to do, his part, in order to improve. And that’s not just him, that’s everybody around him.”

Reviewing the loss, Arnold took full accountability for his mistakes and got to work throughout the bye week to ensure it won’t happen again.

“Obviously it was a heartbreaker, you never want a game to end like that,” he said on Monday. “For me in the quarterbacks room, I’ve got to look back at the film and watch it. I can’t fumble like that, can’t turn the ball over but at the same time, we’ve got two more games. We’ve got two more great teams we’ve got to play so we’ve got to put it behind us and move forward.”

Arnold also said him and the entire team were happy to be able to get an extra week to prepare for the No. 7-ranked Crimson Tide (8-2, 4-2), as Kalen DeBoer’s team continues to get better and better throughout the season.

But Arnold also got another boost on Monday.

He was named a captain by Venables and the coaching staff for the home finale, something that the OU coach said has been earned throughout Arnold’s attitude in practice all throughout the season.

“We love Jackson, and we believe in him,” Venables said. “But it’s a sign of he’s one of our best leaders that we have on the team. And there’s plenty of guys going through, rough spots that still have the ability to lead and fight and compete. So that goes along with that position as well. But representing the offensive side of the ball, those are two of our best leaders, Troy Everett and Jackson Arnold.”

That faith in the coaching staff wasn’t lost on Arnold.

“Yeah, no, it’s awesome,” he said. “Just knowing that the team and the coaches have my back and support me, it’s a good feeling for sure and I’m super appreciative of those guys.”

The Sooners are fully focused on knocking off Alabama and extending the program’s 25-year bowl streak, but there will be plenty of decisions that need to be made in the coming weeks.

Arnold committed to play for then-offensive coordinator Jeff Lebby, but he stayed to take over as OU’s central piece on offense.

The season hasn’t gone to plan, as evidenced by Seth Littrell’s dismissal, and without an offensive coordinator in place for the 2025 season, Arnold declined to shed light on what the next step is for him either way.

“I stay in my lane, I stay focused,” Arnold said about blocking out the outside noise surrounding a potential transfer. “I have Snapchat, so I talk to my friends, talk to my family, call them and talk to my girlfriend, but other than that I don’t go on any social media.

“And regarding my future, like I just — I mean, we’ve got two great teams left that we gotta go against, I’m just taking it week by week.”

So regardless of what the next month brings for Arnold and Oklahoma, the Sooners are focused in getting the best out of their young quarterback over the next eight quarters.

“It’s not him alone. It’s Coach (Kevin) Johns, it’s Coach (Joe Jon) Finley, it’s Coach (Bill) Bedenbaugh and Coach (DeMarco) Murray,” Venables said. “Making sure that their guys are prepared and detailed so that it helps him have success and stay into a rhythm — have a clean pocket and make good decisions. Everybody has a role in that and confidence as a young player is always something.

“The confidence usually comes from the work. And then, I’m not gonna lie, the confidence takes a shot when you’re not successful. And so we gotta do, all of us together, gotta do a good job of hitting it head on.”

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