Federal Court denies attempt to stop Medicare drug negotiation program

Published in RINewsToday on November 6, 2023

Over two months ago, as supporters of President Biden’s Inflation Reduction Act (IRA) celebrated the one-year anniversary of the passage of the historic legislation, the U.S. Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PhRMA), along with drugmakers filed multiple lawsuits to block the IRA’s drug price negotiation provisions.  The drug price negotiation program, created by IRA, allows Medicare to use its bargaining power to negotiate the prices of ten prescription drugs for the first time.

The multiple-filed legal suits came weeks before Sept. 1 when the for Centers Medicare & Medicaid Services (CMS) was scheduled to publish a list of the first 10 drugs that would be subjected to negotiations.  These lawsuits argued that the federal price negotiation program was unconstitutional because it violated the First and Fifth Amendments of the U.S. Constitution, as well as the separation of powers clause, by giving the U.S. Department of Health and Human Services (HHS) discretion over a maximum fair price for any given drug selected for negotiation.  These lawsuits also charge that CMS price controls would force drug makers to pull back on developing new drugs, jeopardizing medical breakthroughs for individuals with life-threatening and chronic illnesses. 

Among the nine lawsuits scheduled to go to trial, one was a motion filed on July 12, 2023 by the Chamber and several of its affiliates in Ohio. This motion requested the court to issue a preliminary injunction to halt the Medicare drug negotiation program from implementation. The ruling came before the Oct. 1, 2023 deadline requiring drugmakers whose pharmaceuticals were selected for negotiations to either sign agreements to participate or to face stiff penalties.  

The U.S. Department of Justice opposed the Chamber’s motion, filing a motion to dismiss its case.  On Sept. 15, 2023, the court held oral arguments giving the  Chamber and the DOJ an opportunity to present their legal arguments in greater detail.  

Overcoming a Major Legal Hurdle 

On Friday, September 29, 2023, U.S. District Judge Michael J. Newman for Southern District of Ohio, denied the Chambers request to block implementation of the newly established Medicare drug price negotiation program before the drug price negotiation talks began.  The ruling called on the Chamber to file an amended complaint by Oct. 13, 2023. DOJ would then have until Oct. 27, 2023 to renew its motion to dismiss.

According to Spencer Kimball of CNBC, legal experts say the pharmaceutical industry hopes to see conflicting rules from lawsuits filed in other federal appellate courts to bring this issue to the Supreme Court for final resolution. 

The Willimantic, Connecticut-based Center for Medicare Advocacy (CMA), a nonprofit group pushing for comprehensive Medicare coverage, health equity and quality of health care for seniors and people with disabilities, is encouraged by Judge Newman’s ruling, which assessed the drug manufacturer’s claims “to be weak in the face of clearly established laws.”

According to CMA, the 28-page court order found that the Chamber and other plaintiffs had demonstrated neither likelihood of success on the merits, nor irreparable harm, which are required for a preliminary injunction.  CMS noted that this case cited “clear” law that “participation in Medicare, no matter how vital it may be to a business model, is a completely voluntary choice.” The court also found that the price established by negotiations cannot be considered ‘confiscatory,’ as the Chamber charges or “a violation of due process, because drug manufacturers can opt out of Medicare entirely.”

Newman’s ruling noted that drugmakers are not compelled to sell drugs at the prices established by the Medicare program and that any economic harm, when the negotiated drug prices take effect in 2026, was too speculative to warrant immediate relief, reported CMS.  However, the court did deny the government’s motion to dismiss the lawsuit entirely, saying that more information on whether the plaintiffs have standing to sue would be beneficial and therefore the judge is allowing for limited discovery to clarify issues related to legal standing, after which the government may renew its motion to dismiss, noted the Medicare advocacy group.

With this ruling, Medicare may move forward with its implementation of its drug negotiation program as this case and others continue to proceed. 

Giving their two cents…

At press time, the Chamber did not respond to a request for comment about the court’s ruling.  But health care and aging advocacy groups issued statements expressing their thoughts about the impact of Newman’s ruling. 

“This is the first major blow to Big Pharma in its legal battles to block the drug price negotiation provisions under the Inflation Reduction Act, says Peter Maybarduk, Public Citizen’s director of the Access to Medicines program.

“The Chamber’s lawsuit lacks merit; the court made the right decision not to grant the injunction, which would have caused needless patient suffering and treatment rationing, notes Maybarduk, calling on drugmakers “to drop their lawsuits and drop their prices.”

“Now, drug companies should agree to participate in the negotiation program in good faith. The program is an important first step in ending the exorbitant prices charged to Medicare enrollees,” adds Maybarduk.

Frederick Isasi, Executive Director of Families USA, happily noted that the Medicare drug negotiation program continues, calling the ruling “a big win for seniors and their ability to purchase life-saving medications. The ability to afford medication is a matter of life and death for millions of older adults. That’s why we are fighting this David and Goliath battle – people deserve to pay a fair price for their drugs and Medicare price negotiation is a critical piece of this puzzle. And let’s not forget each drug subject to fair price negotiation is an old drug that millions of people need and doesn’t have competition,” he notes.

“It never ceases to amaze us that – on one hand – Big Pharma can cry poverty by saying that drug negotiations will hurt their bottom line, while recent earnings reports show they are raking in money hand over fist.  We are glad Judge Michael J. Newman, a Trump appointee in Ohio’s Southern District, saw through this hypocrisy by affirming the Biden administration’s power to begin negotiating the prices of 10 medications with drugmakers,” says Dan Adcock, Director of Government Relations and Policy, of the Washington, DC-based National Committee to Preserve Social Security and Medicare. (NCPSSM).

According to NCPSSM, Drug makers made a whopping $493 billion in revenue from ten drugs that are now subject to price negotiations between CMS and the manufacturer, which have accounted for more than $170 billion in gross Medicare spending, according to a report from the nonprofit, Protect Our Care.

“The court’s decision to allow Medicare drug price negotiations to move forward is welcome news, says William Alvarado Rivera, Senior Vice President for Litigation at AARP Foundation. “Pausing Medicare negotiations would have risked billions of dollars in savings for taxpayers – and countless lives. It is unconscionable that Americans face such high prescription drug costs that many people skip taking medication altogether or must ration it,” he said.

“We’re prepared to fight for as long as necessary to ensure big drug companies can’t charge excessive prices at the expense of patients’ health, says Rivera, noting that the new Medicare negotiation law would bring financial and medical relief to millions of older Americans and their families, and put drugs that treat life-threatening and chronic conditions, from cancer to heart disease, within their reach. Rivera says, “It must not be derailed.” 

Congress has put the breaks to the spiraling costs of pharmaceuticals by giving Medicare the authority to negotiate the price of popular drugs with drug makers.  America’s seniors will continue to suffer financial  hardships and many might even lose their lives by not choosing not to take their costly medications if courts rule in favor of drug companies.  Time will tell.   

U.S. Judge Michael J. Newman ruling denying the U.S. Chamber of Commerce’s request for a preliminary injunction, go to https://www.bloomberglaw.com/public/desktop/document/DaytonAreaChamberofCommerceetalvBecerraetalDocketNo323cv00156SDOh/5?doc_id=X3U600KOGG69QHQBPEU24OS1JMO

A listing of drugmaker revenues of the first ten negotiated drugs, go to https://www.protectourcare.org/by-the-numbers-the-ten-costly-drugs-that-are-now-eligible-to-have-lower-prices-negotiated-by-medicare/

Aging Groups: House GOP Tax Rewrite a Turkey

Published in the Woonsocket Call on November 19, 2017

Thanksgiving approaches the GOP-Controlled House has passed H.R. 1, “Tax Cuts and Jobs Act,” its tax reform legislation, on November 16, by a partisan vote of 227 to 206, with 13 Republicans siding with the Democrats. The House tax bill would dramatically reduce corporate and individual income taxes and would increase the deficit by $ 1.7 trillion over 10 years — — possibly offset by $ $338 billion saved by repealing the Affordable Care Act’s (ACA) individual mandate.

On Thursday, after four days of debate, members of the Senate Finance Committee voted 14 to 12 along party lines to approve their version of the tax package. Now the full Senate is expected to consider the bill after Thanksgiving hoping to quickly get it to President Donald Trump’s desk for his signature.

Medicare and ACA Takes a Hit

Matt Shepard, of the Center for Medicare Advocacy, warns that the GOP’s attempt to overhaul to nation’s tax code is an immediate threat to the Medicare program and healthcare coverage to millions of Americans covered by ACA.

According to Shepard, the nonpartisan Congressional Budget Office projects that the huge cost for the Republican tax plan would result in immediate, automatic and ongoing cuss to Medicare — $25 billion in 2018 alone.

After the GOP’s failed attempts to repeal the ACA, the Senate now uses a provision in its tax rewrite plan to finally repeal the ACA’s individual mandate to purchase insurance coverage in order to help pay for tax cuts, he says. If the GOP tax reform legislation becomes law, 13 million more people will be without health coverage and increasing premiums will disproportionately affect people age 50 who are not yet eligible for Medicare.

“These new dangers are on top of an already bad bill. Congress is engaged in a rushed effort to push through a massive tax cut for corporations and the wealthy, presenting a clear and present danger to health coverage, other vital programs, and families throughout the nation,” says Shepard.

“After adding $1.5 trillion to the federal debt, policymakers will use the higher debt – created by the tax cuts – to argue that deep cuts to Medicare, Medicaid, Social Security, and other bedrock programs are necessary,” predicts Shepard.

Responding to the House passage of its tax reform bill, just days ago, in a statement AARP Executive Vice President and Chief Advocacy & Engagement Officer Nancy LeaMond expressed disappointment in passage, warning that the legislation is harmful to millions of Americans age 65 and over.

Older Tax Payers Get Financial Hit with GOP Tax Code Fix

“AARP estimates H.R. 1 will raise taxes on 1.2 million seniors next year alone. Millions more older Americans will see tax increases in the future, or at best, no tax relief at all,” says LeaMond.

As Congress continues its debate to hammer out tax reform, LeaMond calls on lawmakers to retain the medical expense deduction at the 7.5% income threshold for older tax filers. “Nearly three-quarters of tax filers who claim the medical expense deduction are age 50 or older and live with a chronic health condition or illness. Seventy percent of filers who claim this deduction have income below $75,000.,” she says, urging that Congress also retain the standard deduction for older taxpayers, which helps reduce tax liability and can help seniors avoid a tax increase.

AARP also urges Congress to assist working family caregivers in a new tax code that creates a new, non-refundable tax credit to offset the often high out-of-pocket costs associated with caring for a loved one.

Finally, LeaMond calls on Congress to reject adding a provision in the tax bill that will lead to higher premium costs in the individual insurance market, as well as 13 million Americans losing their health coverage, including 2 million Americans who would lose employer-sponsored coverage.

In a statement, Max Richtman, President and CEO, National Committee to Preserve Social Security and Medicare, calls the House passed tax rewrite, “Robin Hood-in-Reverse tax legislation.” Now, the House Republicans have sent out a “crystal-clear message “that the elderly, disabled, poor, and working class are no longer part of the GOP’s vision for America,” he says.

Blooming Deficit Might Trigger Raid Social Security

“This craven giveaway to the wealthy and big corporations at the expense of everyone else flies in the face of public opinion, basic decency, and good old common sense, says Richtman, “By ballooning the deficit, Republicans have teed up a raid on Social Security, Medicare, and Medicaid to make up the difference,” he warns.

“The repeal of the medical expense deduction will punish seniors paying out of pocket for treatment of chronic and serious diseases – or long-term care., says Richtman.

With Senate Republicans gearing up their efforts to pass their version of the House’s “Tax Cuts and Jobs Act,” Richtman calls on Senators “to show courage and to do what House Republicans refused to [do]: stop the tax juggernaut before it does irreparable harm to our nation.”

If the GOP tax reform legislation is passed by Congress and signed into law by President Trump, we will quickly find out by Christmas if it a financial gift to America’s middle class or a lump of coal in their stockings. Aging groups already know this answer.

House GOP Leadership Puts its Health Care Proposal on Fast-Track

Published in Woonsocket Call on March 12, 2017

After years of calling for the dismantling of Obama’s signature health care law, the 2010 Affordable Care Act (ACA), dubbed Obamacare, an emboldened GOP controlling both the White House and two chambers of Congress, began legislative efforts to substantially change the way the federal government subsidizes health coverage for millions of Americans and puts the brakes on Medicaid expansion that extended coverage to millions more.

On March 6, House Speaker Paul Ryan (R-Wis), with the blessing of President Donald Trump, began his legislative efforts to enact the House GOP’s 123 page health care proposal, the new American Health Care Act (AHCA). Democratic lawmakers and aging groups charge that the AHCA lacks a fiscal estimate from the bipartisan Congressional Budget Office as to how many people will lose their health insurance coverage as a result of the bill or how much it will cost.”

According to rating agency S&P Global Ratings, between 6 million and 10 million people could lose health insurance coverage if the GOP’s health care proposal to “repeal and replace” Obamacare passes. Specifically, there would be a decline in enrollment in the individual health insurance plan market of between 2 million and 4 million people. There would also be a decline of between 4 million and 6 million people in the nation’s Medicaid system after 2020 to 2024, says the recently released analysis.

GOP Health Proposal on Fast-Track

Just hours after AHCA was introduced early in the week, the House Energy and Commerce Committee and Ways and Means Committee began holding markups on their specific portions of the GOP’s health care proposal. After deliberating for almost 18 hours the Ways and Means approved its portion by a vote of 23-16, along party lines. After a marathon 27-hour markup session, the AHCA proposal was approved by the second House panel, Energy and Commerce Committee, by voted 31 to 23, by party line, too. Next week, the House Budget and Rules committees is expected to take up the GOP health care proposal, with a full House floor scheduled for the week of March 20. It has been reported that Ryan hopes to have a bill to President Trump for signature before April recess.

“Obamacare is rapidly collapsing. Skyrocketing premiums, soaring deductibles, and dwindling choices are not what the people were promised seven years ago. It’s time to turn a page and rescue our health care system from this disastrous law,” said House Speaker Ryan in a statement released when AHCA was thrown into the legislative hopper.

Ryan asserted that the GOP health care proposal would “drive down costs, encourage competition, and give every American access to quality, affordable health insurance. It protects young adults, patients with pre-existing conditions, and provides a stable transition so that no one has the rug pulled out from under them.”

The GOP health care proposal would keep two of the most popular provisions of Obama’s ACA, specifically providing health care coverage to people with pre-existing conditions (though insurers would be allowed to charge higher premiums to individuals with lapsed health care coverage) and allowing children to stay on their parents’ health plans until the age of 26.

But, the GOP’s efforts to repeal and replace Obama Care has brought aging groups together to put the brakes on House passage.

Aging Groups Come Out Swinging

Seniors’ advocates object to the ACHA’s impact on federal programs that provide both healthcare and long-term care to retirees. The bill rescinds an 0.9% tax on upper income earners’ wages, which had been used to extend the solvency of Medicare until 2028. Removing the tax decreases Medicare’s solvency by four years, which could lead to benefit cuts down the road. Advocates also decry the age-rating provisions in the repeal bill, which would allow insurers to charge older Americans up to five times as much for premiums as younger enrollees pay. The $4,000 tax credits for near seniors (aged 50-64) which replace Obamacare subsidies won’t make a dent in the premiums that this age group will pay under the GOP plan. Older Americans who can’t afford insurance will then arrive at the threshold of Medicare less healthy, putting additional strain on the system.

“This legislation is a triple whammy for seniors. It’s bad for Medicare beneficiaries, bad for near seniors, and bad for the Medicare program,” says Max Richtman, President and CEO of the Washington, D.C.-based National Committee to Preserve Social Security and Medicare.”

Richmond is especially alarmed that the AHCA also makes radical changes to the Medicaid program. The bill cuts $370 billion from Medicaid over 10 years by imposing “per capita caps,” meaning that states will get a fixed federal payment per beneficiary instead of the guaranteed match they now receive. Those fixed payments will not be able to keep pace with rising healthcare costs, leaving the states with significant shortfalls. “Millions of seniors rely on Medicaid for skilled nursing care, both in the home and at community-based facilities. The cut in federal payments will compel states to remove seniors from Medicaid rolls or radically reduce benefits, forcing them and their families into poverty.”

Following the release of the GOP’s AHCA, the Washington, D.C.-based AARP, the nation’s largest advocacy group representing over 37 million members, came out swinging. The GOP legislative proposal would weaken Medicare, leaving the door open to a voucher program that shifts costs and risks to seniors, warned AARP Executive Vice President Nancy LeaMond in a statement.

“Before people even reach retirement age, big insurance companies would be allowed to charge them an age tax that adds up to thousands of dollars more per year. Older Americans need affordable health care services and prescriptions. This plan goes in the opposite direction, increasing insurance premiums for older Americans and not doing anything to lower drug costs, noted LeaMond.

LeaMond charged, “On top of the hefty premium increase for consumers, big drug companies and other special interests get a sweetheart deal. “Finally, Medicaid cuts could impact people of all ages and put at risk the health of 17.4 million children and adults with disabilities and seniors by eliminating much needed services that allow individuals to live independently in their homes and communities.”

“Although no one believes the current health care system is perfect, this harmful legislation would make health care less secure and less affordable,” says LeaMond, noting that her nonprofit aging group will work with either political party to hammer out a health plan that “puts Americans’ health care first, not the special interests.”

Adds Judith Stein, executive director of the Center for Medicare Advocacy in a statement, “the proposed AHCA would also gut key financing mechanisms of the Affordable Care Act that would amount to tax cuts for the wealthy – by some estimates, by hundreds of billions of dollars. Regrettably, these tax cuts include provisions that would jeopardize Medicare’s financial stability. “We fear such cuts will lead to renewed calls to ‘save’ Medicare by privatizing it for future generations,” says Stein.

According to the Center for Medicare Advocacy’s statement, the proposed GOP legislative proposal would dismantle key structural supports of ACA, including eliminating the employer coverage mandate and the individual mandate to obtain health coverage, and instead would impose a 30 percent penalty for lapses in coverage. Instead of the ACA’s subsidies that make health coverage more affordable for millions, the new legislation would offer age-based tax credits ranging from about $2,000 to $4,000 – likely insufficient to pay for meaningful insurance coverage.

The Medicare Advocacy Group also warns that older Americans needing health insurance coverage before becoming Medicare eligible would also be hit hard by the proposed AHCA. The ACA’s protection of older adults that prevents insurance companies from charging no more than three times the premium amount charged of younger individuals (a 3:1 ratio) would be replaced by a higher 5:1 ratio – this dramatically increasing the premium amount insurance companies can charge older adults. Critics call this change an “age tax.”

Finally, the Republican’s AHCA would also phase out ACA’s expansion of Medicaid starting in 2020, structurally reforming virtually the entire Medicaid program (including Medicaid expansion). These changes would have a devastating impact on providing health care by capping federal Medicaid payments to each state to a limited, preset amount per person (often referred to as a “Per Capita Cap”).

Could Political Backlash Happen with Passage of AHCA?

Last Thursday, Ryan, with sleeves rolled up, urged GOP lawmakers to back AHCA, promising tweaks to address Republican conservatives’ concerns. At the 23 minute news conference, Ryan said: “This is the closest we’ve been to repealing and replacing Obamacare and it’s the closest we will ever get to repealing and replacing Obamacare.” It is either voting for the House bill, or let ACA survive, he said.

President Trump also chimed in to the AHCA debate, too, by calling for the controversial health care proposal’s enactment in an afternoon tweet. “Despite what you hear in the press, health care is coming along great. We are talking to many groups and it will end in a beautiful picture!,” he tweeted.

As the Congressional April recess approaches opposition to AHCA is building as physician, nurse and hospital groups warn that the legislative proposal’s enactment will take health care coverage away from millions of Americans. While Democratic and progressive organizations oppose ACA’s passage, too, a growing number of GOP lawmakers and conservative groups, from the Cato Institute, Americans for Prosperity and Tea Party Patriots, are expressing their concerns.

Days ago, Andrev Ostrovskv, chief medical officer for Medicaid at the Baltimore, Maryland-based Centers for Medicare and Medicaid based, risking the wrath of Trump’s political appointees in his federal agency, tweeted his displeasure and opposition. “Despite political messaging from others at HHS [Health and Human Services], I align with the experts from @aafp @AmerAcadPeds @AmerMedicalAssn in opposition to #AHCA,” he tweeted. Dr. Ostrovskv’s agency oversees the administering of Obamacare.

Even if the GOP House Leadership are able to address conservative lawmaker concerns, one being AHCA does not require an earlier halt to Medicaid expansion enrollment, the GOP’s health care proposal appears to have a rocky road to travel in the upper chamber. Senate. Republications, having just a 52-48 slim majority, can only lose two votes.

Says Senator Tom Cotton (R-Arkansas) in a tweet to House GOP Leadership: “ House health-care bill can’t pass Senate w/o major changes. To my friends in House: pause, start over. Get it right, don’t get it fast.”

With the popularity of Obamacare the GOP’s death wish to repeal and replace the law may well be hazardous to the Republican Party’s political health. We’ll find out for sure in the mid-term elections.