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/

Older Americans Month: great time to bring back House Aging Committee

Published in RINewsToday on May 9, 2022

On April 29, President Joe Biden proclaimed the month of May, Older Americans Month for 2022 to honor the nation’s 54.1 million Americans aged 65 and over “who contribute their time and wisdom to make our communities stronger, more informed, and better connected.”

“Older adults have always been a vital source of strength and resilience in America,” stated Biden in the proclamation.  During the pandemic, many seniors came out of retirement to serve their communities in health care and education roles, filling job vacancies in critical shortage areas. Moving forward, we must ensure that older Americans have the appropriate resources to maintain their independence and stay connected to their communities,” he said.

The proclamation also noted that the nation is celebrating the 50th anniversary of the Older Americans Act Nutrition Program — the first federal program to support the well-being of older Americans through meal deliveries, nutrition services, educational programs, and counseling. This year is also the 10th anniversary of the nation’s National Plan to Address Alzheimer’s Disease and recommit to building upon this important work being done.

Biden recognizing this month in honor of seniors follows the footsteps of 11 presidents, beginning with President John F. Kennedy in 1963, when only 17 million Americans had reached their 65thbirthday. At that time,  about a third of America’s seniors lived in poverty and there were only a few federal programs to meet their needs. A meeting in April 1963 between Kennedy and the National Council of Senior Citizens led to designating May as “Senior Citizens Month,” later renamed “Older Americans Month.”

Over the years, OAM is a time the nation acknowledges the contributions of past and current older persons to our country, in particular those who defended our country. Communities across the nation pay tribute at ceremonies, events, and fairs, or in other ways to older persons in their communities.  

OAM – a great time to bring back the House Aging Committee

As the nation celebrates OAM, an eblast to over 90,000 seniors by the National Committee to Preserve Social Security and Medicare (NCPSSM) urged these older voters to call their congressmen to request them to cosponsor Rhode Island Congressman David Cicilline’s H. Res. 583, to reestablish the House Select Committee on Aging (HSCoA). “It couldn’t be a better time to highlight the urgent need to reinstate this investigative committee which would help restore Congressional focus on key policy issues [Social Security, Medicare, housing, prescription drugs, and long-term care] impacting the nation’s seniors says the Benefits Watch newsletter.   

“Today, with seniors representing a growing portion of the U.S. population and several federal programs that seniors rely on at an inflection point, there is an increasing need for a House committee that advocates for older Americans,” says NCPSM’s email, noting that’s why the Washington, DC-based advocacy group has signed onto the Leadership Council on Aging Organization’s (LCAO) letter calling on the House to pass H. Res. 583. 

“While there are other committees with jurisdiction over seniors’ programs, there is no single committee dedicated to keeping an eye on the big picture for seniors.  Fortunately, the Senate Special Committee on Aging has continued to operate in the absence of a House counterpart,” notes NCPSSM’s email, noting that “seniors would benefit from a reinstated and robust HSCoA, whose sole mission would be to look out for older American’s needs.

National Aging Groups, former Pepper staffer weighs in

“Older Americans month would be the perfect time to bring back the Aging Committee,” says Bob Weiner, former Chief of Staff under chairman Claude Pepper of the House Select Committee on Aging. “It’s sorely missing now. With Pepper’s legacy as the guide, pandemic deaths, nursing homes, home health care, Social Security, and Medicare would be improved by the sunlight of oversight. Seniors are now vulnerable and threatened by what could happen and having the Aging Committee back would reinstate the wall of protection that Pepper gave them,” he says. 

“The LCAO supports the establishment of HSCoA to provide an important forum for discussion, debate and exploration of issues impacting an aging society,” says Katie Smith Sloan, chair of the Leadership Council of Aging Organizations (LCAO), a coalition of 69 Washington, DC-based aging organizations. “Addressing the needs of older adults and families, which are increasingly prevalent with our population shifts, now, as we celebrate Older Americans Month, is appropriate – and urgent,” says Sloan. LCAO sent a letter to members of Congress on March 4, 2022, urging them to cosponsor H. Res. 583. 

“Passing H Res 583 in May to coincide with it being Older Americans month would make eminent policy and political sense.  It is an investment in having a stronger and dedicated advocacy voice for older adults in the House which has been missing for almost 20 years,” says Robert B. Blancato, National Coordinator of the Elder Justice Coalition, who was the longest serving staff person on the original House Aging Committee, from 1977 to 1993.

“As our country’s older adult population continues to grow each day, so does the urgency with which we need to pursue effective solutions to myriad aging issues,” says Erika Kelly, Chief Membership and Advocacy Officer of Meals on Wheels America. “To see the House pass this resolution to reestablish the HSCoA during Older Americans Month would be a tremendous step forward,” she says.

“Older Americans Act programs, like Meals on Wheels, will undoubtedly face the lingering impact of the pandemic and other challenges for years to come. Having this HSCoA come [back] to life again, especially during this celebratory month, would provide critical leadership and attention when it’s needed most and make a difference in the lives of tens of millions of older adults,” says Kelly.

Finally, Cicilline, H. Res. 583’s sponsor and the NCPSSM tells us why it is important for House Speaker Nancy Pelosi and her Democratic leadership colleagues to support and bring H. Res. 583 to the House Rules Committee for a vote during Older Americans Month.

“With Older Americans Month upon us, this is an important moment to underscore how the pandemic has disproportionately impacted seniors. Now, with growing concerns about inflation, seniors on fixed incomes will bear the burden of the rising cost of prescription drugs, food, housing, and other essentials. A House Permanent Select Committee on Aging would help Congress focus on, study, and address the issues that affect seniors to make sure they can live the rest of their lives with dignity and security,” says Cicilline.

“When there was a HSCoA before it was abolished in 1995, the investigative House committee held hearings on aspects of the Older Americans Act leading up to the 1992 reauthorization of the law,” noted NCPSSM’s Dan Adcock, Director of Government Relations and Policy. “The findings of these hearings were helpful to the House Committee on Education and Labor which had legislative jurisdiction over the Older Americans Act.  The Subcommittee on Human Resources [now called the Civil Rights and Human Services Subcommittee] under the full Education and Labor Committee held several of its own hearings on the OAA, too – including field hearings held across the country — leading to the enactment of the 1992 reauthorization., he said. 

According to Adcock, during that period of time, there was significant communication between the House Aging Committee staff and the Ed and Labor Committee and Human Resources Subcommittee staff.  But the legislative language was written and marked up by the latter. “A reestablished HSCoA could play a similar role in the future, but the panel’s ability to have an impact on legislation drafted by the authorizing committees would depend on the cooperation between the respective committee chairs and staff and the degree of relevancy of the hearings held by a reconstituted House Aging Committee,” he says. 

Over 400 senior groups support H. Res. 583

While LCAO is a pretty diverse group of national aging organizations – each with their own policy priorities, the coalition of 69 members, representing over 100 million over 50, and 50 million over 65 came together to endorse and affirm their support of Cicilline’s resolution.  

Ms. Nancy Altman, President of Social Security Works and Chair of the Strengthen Social Security Coalition, strongly supports the passage of H. Res. 583 and that her coalition of 350 national and state organizations representing 50 million Americans endorses Rep. Cicilline’s resolution.  

As we celebrate OAM, it is key to House Speaker Nancy Pelosi, Majority Leader Steny Hoyer (D-MD) and Whip James Clyburn (D-SC) to join Cicilline along with Congresswomen Jan Schakowsky (D-IL) and Doris Matsui (D-CA), cochairs of the Task Force on Aging and Family and 43 cosponsors of H. Res 583, giving the green light to the House Rules committee to vote, and if approved send it quickly to the floor.

H. Res. 583 does not require Senate consideration and only requires a House Rules and floor vote for passage.  Passing the reestablishment of an investigative committee in the House would send a powerful message to older Americans that Congress following in Pepper’s footsteps will again get serious in addressing aging issues. 

As mentioned in previous commentaries, bringing back the HSCoA is a winning federal policy to positive impact America’s seniors and this group.  It’s the  right thing to do especially at a time when seniors have been a disproportionately impacted by the continuing COVID-19 pandemic.    

Over 450 national and state aging organizations representing conservatively over 150 million seniors, support the enactment of H. Res. 583. That’s a great reason for the lower chamber to strongly support.

To see the LCAO’s letter sent to Congress on March 4, 2022, endorsing H. Res. 583, go to https://www.lcao.org/wp-content/uploads/2022/03/House-Aging-Committee-LCAO-Letter-3-4-22.pdf.

For a historical background of the HSCoA and details about H. Res. 583, go to https://rinewstoday.com/congressman-cicilline-poised-for-legacy-as-next-fiery-advocatsie-on-aging/.

For details about Congressman Claude Pepper (D-FL) Congressman, during his six-year serving as chair of the HSCoA, go to https://rinewstoday.com/congressman-cicilline-poised-for-legacy-as-next-fiery-advocate-on-aging/.

Seniors would benefit in President Biden’s $6 trillion budget

Published in RINewsToday on June 14, 2021

On May 28, with the release of a $6 trillion budget for fiscal year (FY) 2022, President Joe Biden outlined his values and vision as to how he proposes to revive the nation’s sputtering economic engine as it emerges from the devastating impact of the COVID-19 pandemic. The 72-page budget document, “Budget of the United States,” (with more than a 1,400-page appendix) details his spending priorities that begin next Oct. 1. Biden’s generous budget depends on increasing taxes on America’s corporations (from 21 to 28 percent) and high earners, who received significant tax breaks from the President Trump/GOP tax cuts of 2017.

With the FY 2022 Budget pushing federal debt to the highest levels since World War 1I, Republican lawmakers quickly called the proposal “dead on arrival” in Congress.  However, Cecilia Rouse, chair of President Biden’s Council of Economic Advisors says the Biden Administration is willing to live with a budget deficit to invest in the economy now, especially with low interest rates to borrow; deficits can be reduced later. 

President Biden’s new spending under the just released proposed FY 2022 budget, recognizing his Administration’s priorities, reflects the major proposals already outlined under the administration’s $2.3 trillion American Jobs Plan and $1.8 trillion American Families Plan. Provisions in these two proposals would overhaul the nation’s aging infrastructure and invest in education, childcare, paid family and medical leave, fight climate change. 

President Biden’s spending plan also recognizes priorities outlined in the American Rescue Plan passed earlier this year as well as the Administration’s “skinny” discretionary budget request released in April. Most importantly, it reflects a commitment from the president to safeguard Medicare, Medicaid and Social Security.

Loving It or Hating It Depends on Where You Sit

In remarks delivered Thursday in Cleveland, President Biden made the case for his budget request and what he describes as an investment in the country’s future. “Now is the time to build [on] the foundation that we’ve laid to make bold investments in our families and our communities and our nation,” he said. “We know from history that these kinds of investments raise both the floor and the ceiling over the economy for everybody.”

In the FY 2020 Budget proposal’s “Message from the President”, Biden says, “The Budget invests directly in the American People and will strengthen the nation’s economy and improve our long run fiscal health. It reforms our broken tax code to reward work instead of wealth while fully paying for the American Jobs and American Family Plans over a 15- year period. It will help us build a recovery that is broad-based, inclusive, sustained, and strong,”

Of course, response to Biden’s Spending plan depends on which side of the aisle you are sitting.

House Speaker Nancy Pelosi (D-CA) released a statement strongly endorsing Biden’s fiscal blueprint. “Congressional Democrats look forward to working with the Biden-Harris Administration to enact this visionary budget, which will pave the path to opportunity and prosperity for our nation. The Biden Budget is a budget for the people,” she said.

On the other hand, Senate Minority Leader Mitch McConnell strongly opposing Biden’s Budget proposal. “Americans are already hurting from far-left economics that ignores reality,” said McConnell, in a statement. “The Administration’s counterproductive ‘COVID relief bill’ has slowed rehiring. Families are facing painful inflation, just as experts warned the Democrats’ plans might cause. And the Administration wants to triple down on the same mistakes?” said the six-term Republican Kentucky Senator.

With the Democrats holding the slim majorities in the House and Senate and controlling the White House, Biden’s FY 2022 Budget proposal will have more weight than if the Republicans were in the majority, says Dan Adcock, Government Relations and Policy Director at the Washington, DC-based National Committee to Preserve Social Security and Medicare (NCPSSM).

According to Adcock, Biden’s funding numbers will change as his FY 2022 budget proposal goes through the appropriation process in the upcoming months. With its release, Congress can now begin negotiating funding levels and spending bills. Competition for a finite amount of funding will ultimately result in funding level ultimately allotted to programs and agencies by each of the 12 appropriations under their jurisdiction. Funding for most programs important to older Americans is under the jurisdiction of the Subcommittee on Labor, Health and Human Services and Education.

“With 10,000 Baby Boomers turning 65 every day – and the number of seniors projected to double by 2050 – it’s clear that President Biden understands the need to safeguard the older Americans he calls ‘pillars of every community – now and into the future.” Says Max Richtman, NCPSSM’s President and CEO.

Slashing Drug Costs to Pay for Expanding Medicare Coverage

Richtman says that Biden’s fiscal blueprint calls on Congress to allow Medicare to negotiate prices for certain high-cost, life-saving drugs that many seniors currently cannot afford and to require manufacturers to pay rebates when drug prices rise faster than inflation. These reforms could yield over half a trillion in federal savings over 10 years, which could help pay for coverage expansions and improvements, including access to dental, hearing, and vision coverage in Medicare,” he notes. Today, traditional Medicare does not cover routine care like dental checkups or hearing aids.

According to Richtman, President Biden’s budget also includes more than $400 billion in new spending over ten years to expand Home and Community-based Services (HCBS) for low-income seniors and people with disabilities who prefer to receive skilled care in the comfort of their homes and communities, even moreso after the devastation COVID wrought on nursing homes.  

In states that have not taken advantage of Affordable Care Act (ACA) opportunities to expand Medicaid, the budget proposes providing premium-free, Medicaid-like coverage through a federal public option, along with incentives for states to maintain their existing expansions. 

Biden’s FY 2022 budget also urges Congress to improve customer service for Social Security beneficiaries to prescription drug pricing reform to expanded HCBS, adds Richtman.  It also proposes a $1.3 billion (or 9.7%) funding increase for the Social Security Administration.  The increase seeks to improve customer service, including services at SSA’s field offices, state disability determination services, and teleservice centers.

 The Older Americans Act (OAA) provides funding for a wide range of home and community-based services, such as meals-on-wheels and other nutrition programs, in-home services, transportation, legal services, elder abuse prevention and caregivers’ support. These programs help seniors stay as independent as possible in their homes and communities. 

For details about Biden’s FY 2022 Budget proposal and OAA funding levels, made available from the Washington, DC-based National Association of Area Agencies on Aging, go to: https://www.n4a.org//Files/FY22%20PresBudget%20and%20historical%20Labor-HHS%20Appropriations%20Chart.pdf

 Stay Tuned 

The House continues its work on hammering out appropriation bills through subcommittees in June and in the full House in July.  The Senate’s work is expected to begin in mid-Summer and to continue well into September. If the appropriate bills are not passed and signed into law by Oct. 1, Congress will need to pass a continuing resolution to fund the federal government into the first months of FY 2022.

Like most Budget proposals, especially in a partisan Congress, Biden’s spending plan will need to be rewritten to win support from lawmakers on both sides of the aisle. However, it will serve as a roadmap for a Democratic controlled Congress in crafting 12 appropriation spending bills. Partisan bickering during the appropriations process may well force passage of a continuing resolution before Oct. 1 to block a government shutdown.