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/

Senate bipartisan proposal boon to nation’s family caregivers

Published on October 30, 2023

Many family caregivers will tell you that coping with the stress of providing care to loved ones, is made more difficult when they are forced to navigate the confusing federal bureaucracy to identify key financial and health care programs for support. Last week, S 3109, the Alleviating Barriers for Caregivers (ABC) Act, was thrown into the legislative hopper to make it easier for more than 48 million family caregivers to obtain this information. The Senate caregiver proposal was referred to the Senate Finance Committee and no House companion measure has been introduced at press time. 

On Oct. 24, the bipartisan Senate proposal was introduced by Senators Edward Markey (D-MA) and Shelley Moore Capito (R-WV) and is co-sponsored by Senators Kyrsten Sinema, (I-AZ), Susan Collins (R-ME), Bob Casey (D-PA), and Thom Tillis (R-NC). The proposal would require the Administrator of the Centers for Medicare & Medicaid Services and the Commissioner of Social Security to review and simplify the processes, procedures, forms, and communications for family caregivers to assist individuals in establishing eligibility for, enrolling in, and maintaining and utilizing coverage and benefits under the Medicare, Medicaid, CHIP, and Social Security programs respectively, and for other purposes. The agencies must conduct a review and seek input from family caregivers prior to taking actions that would improve their experiences coordinating care for their loved ones.

Currently, more than 48 million family caregivers in the U.S. help take care of loved ones. According to AARP and the National Alliance for Caregiving in the U.S. report, caregivers provide support ranging from selecting the best providers; coordinating multiple health and long-term care providers; navigating the care system; advocating with providers, community services, and government agencies; and managing medications, complex medical tasks, meals, finances, and more.

According to AARP, most caregivers say additional information and support for managing these needs is essential. One in four family caregivers (25%) report they want help figuring out forms, paperwork, and eligibility for services and 26% say that it is difficult to coordinate care across various providers and services. While most (61%) work full- or part-time, and some also care for children, family caregivers spend almost 24 hours a week caring for a loved one on average, says the Washington, DC-based advocacy group.

Personal caregiving experiences leads to calls for caregiver assistance 

Being family caregivers, both Senators Markey and Capito, primary sponsors of S 3109, like many caregivers, encountered red tape when they attempted to find needed federal caregiving programs and services to care for their parents.

“When my mother suffered from Alzheimer’s, my father was her caregiver in our home in Malden,” remembers Senator Markey. “Caregivers serve on the frontlines of our nation’s health care system by giving our families and friends the care and support they need to remain in their homes and communities with their loved ones. However, our aging and disabled community members can’t get the care they need if their caregivers – the backbone of their treatment – are struggling to navigate complex, burdensome, and stressful processes each and every day while also still managing day-to-day family and professional responsibilities. 

“As a caregiver for my parents during their struggle with Alzheimer’s disease, I know personally the level of responsibility put on family caregivers and the burdens, which can be created by federal process and procedure,” said Senator Capito. “Caregivers in West Virginia and across our country put family first and balance multiple priorities at once, which is why we must do all we can to alleviate roadblocks that could delay and even prohibit them from receiving the support they need,” she said. 

Calls for upper Chamber to pass caregiver proposal

At press time, 32 national aging and health care strongly support passage of S 3109.

“Family caregivers are the backbone of our nation’s long-term care system, and they are overwhelmed with their responsibilities and time spent managing their loved one’s care,” said Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond. “The Alleviating Barriers for Caregivers Act could help save family caregivers valuable time and reduce their stress by making it easier to navigate resources, eligibility, benefits, and health systems when providing care, she says.  

“Our concern is that these federal caregiver programs are so complicated, they become virtually inaccessible, discouraging family and friends from providing caregiving services. The ABC Act is the first step to holding CMS and SSA accountable for eliminating these barriers to caregiving so people with intellectual and developmental disabilities can live their lives in the community,” said Robin Troutman, Deputy Director at National Association of Councils on Developmental Disabilities.

“The Rosalynn Carter Institute for Caregivers (RCI) supports the Alleviating Barriers for Caregivers Act. Far too often family caregivers are faced with burdensome administrative obstacles in accessing the resources and supports to which they’re due. As system fragmentation is a significant component of caregiver strain, we commend this important first step to better streamline, simplify, and coordinate access across federal programs, said Dr. Jennifer Olsen, CEO of the Rosalynn Carter Institute for Caregivers.

“Being a caregiver to someone living with Alzheimer’s is already an incredibly difficult and emotionally draining job. When you layer on top of it the daunting task of navigating our country’s complex healthcare coverage system, it can become downright overwhelming for even the smartest person. This bill is an important step toward making it easier for caregivers to fully advocate on behalf of their loved ones to ensure they have access to the diagnostic, pharmaceutical, and treatment services they need, said George Vradenburg, Chair and Co-founder of UsAgainstAlzheimer’s.

Congress must come together to support caregivers

Family caregivers across the national  provide 36 billion hours of unpaid care, valued at an estimated $600 billion annually. In the Ocean State, 121,000 family caregivers provide 113 million hours of unpaid care valued to be 2.1 billion. These caregivers need assistance from Congress to access resources to provide care to their loved ones. 

There is 372 days left until the 2024 president elections. AARP research tells us that a majority of voters, 78%, are either a current, past, or future family caregiver. Over 70% of voters across the political spectrum say they would be more likely to support a candidate who backed proposals to support family caregivers, such as a tax credit, paid family leave, and more support and respite services.

Hopefully, more Senators will see the value of S. 3109 and quickly become cosigners. It’s time the newly elected House Speaker Mike Johnson (R-LA) and his caucus put the need of their caregiver constituents first, over their political priorities, and support passage of a House companion measure. The House Problem Solvers Caucus can be instrumental in pushing for the introduction and passage. Time will tell.

For more information about caregiving, go to www.aarp.org/caregiving.

For a copy of the 2022 National Strategy to Support Family Caregivers, go to https://acl.gov/sites/default/files/RAISE_SGRG/NatlStrategyToSupportFamilyCaregivers.pdf

Putting the brakes on CMS proposed minimum staffing for nursing facilities

Published in RINewsToday on October 23, 2023

In response to the Centers for Medicare and Medicaid Services (CMS) recent release of proposed rule to establish minimum federal staffing requirements, last week 97 members of Congress, mostly Republican, called on Health and Human Services (HHS) Secretary Xavier Becerrato put the breaks on CMS’s proposed rule issued on Sept. 1, 2023.

In September, CMS issued a proposed rule establishing minimum staffing requirements and standards for nursing facilities. But the proposed CMS rule notes that according to the Bureau of Labor Statistics, “there are roughly 235,900 fewer health care staff working in nursing facilities and other long-term care facilities compared to March of 2020.”  Furthermore, the proposed CMS rule notes that nursing facilities around the country would need to hire nearly 13,000 registered nurses and 76,000 nursing assistants. Safety thresholds could increase a modest 1% while costing between $1.5 to $6.8 billion to fully implement. Noncompliance with CMS’ proposed minimum staffing requirements would lead to citations for noncompliance with Medicare Conditions of Participation, potentially resulting in a variety of enforcement actions, including imposition of Civil Monetary Penalties, denial of payments for new admissions, and even termination from the Medicare program.

Congressional call to CMS to reconsider minimum staffing rule

Congressman Greg Pence (R-IN), along House colleagues Brett Guthrie (R-KY), Vern Buchanan (R-FL), Michelle Fischbach (R-MN), Jared Golden (D-ME), and Chris Pappas (D-NH), along with 91 of their Republican colleagues sent a bipartisan letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, opposing minimum federal staffing requirements.

In this Oct. 20 letter, they charge that CMS’s rule would inevitably result in limited access to care for seniors, mandatory increases in state Medicaid budgets, and most consequentially lead to widespread nursing facility closures. they urge the Secretary to reconsider the proposal to impose new federal staffing requirements on nursing facilities which would adversely hurt their ability to serve existing and prospective residents.

In the letter, the lawmakers expressed their concerns with CMS proposed rule issued at the direction of the Biden White House. This rule would establish minimum staffing requirements and standards for nursing facilities, which they warned would inevitably result in limited access to care for seniors, mandatory increases in state Medicaid budgets, and most consequentially lead to widespread nursing home closures.

“At a time when nursing homes are already experiencing healthcare worker shortages and financial hardships, CMS and the Biden Administration should not be implementing a regulation that would only exacerbate this issue. If implemented, facilities throughout the country will have no choice but to deny access to our nation’s seniors who need nursing home care, especially in rural communities, like many of the ones I represent in Indiana’s sixth congressional district,” said Congressman Pence. “This one-size-fits-all regulatory requirement will result in many negative consequences, and I strongly urge Secretary Becerra to reconsider this proposal,” he said.

“There are workforce shortages all across rural America and healthcare workers are no exception. I’m committed to working with my colleagues to find ways to prevent otherwise avoidable closures of nursing homes in Maine,” said Congressman Golden.

Nonprofit provider group calls on Congress to stop CMS proposed rule

The Washington, DC-based LeadingAge, representing more than 5,000 nonprofit aging services providers, gave the thumb up to House lawmakers who are attempting to delay CMS’s proposed rule until there are enough qualified applicants and adequate funding to address staffing levels realistically throughout the long-term care continuum.

“We all want to ensure access to quality care for older adults, but federal leaders are getting it wrong right now,” said Katie Smith Sloan, president and CEO, Leading Age, the association of nonprofit providers of aging services, including nursing homes. “CMS’s proposed nursing home staffing mandate rule works against that shared goal, and would limit older adults’ and families’ access to care,” she said.

In a letter sent to Congressional leaders on Sept. 28, 2023 addressing the Centers for Medicare and Medicaid Services (CMS) September 1 proposed rule on nursing home staffing mandates, Sloan urged policymakers to focus on advancing real solutions to ensure quality nursing home care for older adults and families across America. 

Sloan’s letter lays out three main reasons why the proposed rule will be impossible to implement.  She notes that no federal funding has been allocated to cover the $7.1 billion price tag of CMS’s proposed regulation.  She warns that the mandate would require the hiring of 90,000 more workers, and there are simply not enough people to hire.  Finally, the mandating staffing requirements could decrease access to care across the continuum of care, says the top aging services executive.

The letter asks Congress to intervene to delay the proposed rule until there are enough qualified applicants and adequate funding to address staffing levels. Sloan provides her association’s independent cost analysis of the proposed rule, which projects implementation would be at least $7.1 billion—far higher implementation than CMS estimates.

“The costs of delivering quality care already far exceed Medicaid reimbursement levels, and this unfunded mandate will force nursing homes to consider limiting admissions or even closing their doors for good, depriving older adults and their families of care in their communities,” states the letter, noting that “the outcome is the opposite of what providers, lawmakers, the administration and the American people want.”

According to Sloan, nursing facilities aren’t the only part of the healthcare system that will be affected if the rule is implemented as proposed. Home health providers are already rejecting referrals and some face closure due to financial pressures and workforce shortages. There will be far fewer options for older adults and families to access care, and communities of color and less affluent individuals will feel the deepest impact, she says. 

“The current and highly fragmented approach to long-term care financing no longer serves the millions of older adults who require compassionate and highly skilled care,” writes Sloan, calling on Congress to work with the Administration on realistic solutions, including a “robust national workforce development strategy.” 

LeadingAge has put forward solutions to tackle the aging services workforce crisis including prioritizing immigration reform to help build the pipeline of workers; increasing funding and working with states to increase Medicaid reimbursement rates to cover the cost of care and increase wages; along with replicating existing successful training programs and expand opportunities for interested applicants to pursue careers as RNs, LPNs, and CNAs. 

“We need a holistic approach to real solutions to the workforce crisis. Let’s get this right,” said Sloan.

A Rhode Island perspective

“Unfortunately, a staffing ratio mandate, whether state or federal, is a blunt enforcement instrument that does not consider the numerous challenges facing providers, including Medicaid underfunding, lack of workforce, and the diversity of nursing homes and their resident needs,” says James Nyberg, president, and CEO of LeadingAge Rhode Island. “Moreover, the concept of imposing severe financial penalties for homes that are unable to meet a staffing ratio is counterproductive at best by siphoning off scarce resources that providers need as they seek to address their workforce needs and resident care needs,” he says. 

“We in Rhode Island can attest that there are numerous unintended consequences of a staffing ratio mandate, including the severity of fines, how compliance is measured and calculated, costs of compliance (or trying), backlogs of people in hospitals waiting for skilled nursing care, and other access-related issues, says Nyberg, noting that even homes that are currently able to comply with the staffing ratio are doing so at an unsustainable cost. 

According to Nyberg, a staffing ratio mandate without an adequate workforce supply, as well as financial resources, poses an existential threat to the industry. LeadingAge Rhode Island is working with state officials and other stakeholders to revisit some of the more onerous provisions of our mandate, mitigate its effects, and pursue other less punitive approaches to meeting collective goal of ensuring adequate staffing and quality of care while also working on various initiatives to develop a pipeline of workers, which will quite simply take time. 

For a copy of the Oct. 20 correspondence sent to HHS Secretary Xavier Becerra urging her to reconsider establishing minimum staffing in nursing facilities, go to https://drive.google.com/file/d/1RzhXgF2OQR-cbz8fA5I4yE0DWYn8fDJM/view.

To read LeadingAge’s Sept. 28 correspondence to Congress, go to https://leadingage.org/wp-content/uploads/2023/09/LeadingAge-Staffing-Mandate-Analysis-Congressional-Letter-9-28-2023.pdf.

For a copy of a CMS Fact Sheet on CMS’s proposed rules on minimum staffing, go to https://www.cms.gov/newsroom/fact-sheets/medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid