Tag Archives for CMS

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/

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

Increased funding must be tied to nursing home mandated minimum staffing

Published in RINewToday on Sept 25, 2023

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to establish comprehensive staffing requirements for nursing homes—including, for the first time, national minimum nurse staffing standards. The proposed rule seeks to would ratchet up the quality of care in the nation’s 18,700 skilled nursing facilities, delivering care to 1.2 million residents each day.

“Establishing minimum staffing standards for nursing homes will improve resident safety and promote high-quality care so residents and their families can have peace of mind,” said HHS Secretary Xavier Becerra in comments on Sept. 1, 2023. “When facilities are understaffed, residents suffer. They might be unable to use the bathroom, shower, maintain hygiene, change clothes, get out of bed, or have someone respond to their call for assistance. Comprehensive staffing reforms can improve working conditions, leading to higher wages and better retention for this dedicated workforce,” says Becerra.

The Nuts and Bolts of CMS’s proposed ruling

Under CMS’s proposal, nursing homes participating in Medicare and Medicaid would be required to meet specific nurse staffing levels that promote safe, high-quality care for residents. Nursing homes would need to provide residents with a minimum of 0.55 hours of care from a registered nurse per resident, per day, and 2.45 hours of care from a nurse’s aide per resident, per day, exceeding existing standards in nearly all states. CMS estimates approximately 75% of nursing homes would have to strengthen staffing in their facilities. As the long-term care sector continues to recover from the COVID-19 pandemic, the proposed standards take into consideration local realities in rural and underserved communities through staggered implementation and exemptions processes.

In addition, nursing homes would also be required to ensure a registered nurse is on site 24 hours a day, 7 days per week, and to complete robust facility assessments on staffing needs. Facilities would continue to be required to provide staffing that meets the needs of the individual residents they serve, which may require higher levels of staffing above the proposed minimum standards.  

CMS also proposed to require states to collect and report on compensation for workers as a percentage of Medicaid payments for those working in nursing homes and intermediate care facilities. These policies build on CMS’ recent proposals to support compensation for direct care workers in home and community based settings and to publish Medicaid data on average hourly pay rates for home care workers. This enhanced transparency will aid efforts to support and stabilize the long-term care workforce across settings strengthening access to high-quality long-term care both at home, in the community as well as in nursing homes and other facilities.

Attracting and supporting Nursing Home staff

Additionally, CMS announced a national campaign to support staffing in nursing homes. As part of the HHS Workforce Initiative, CMS will work with the Health Resources and Services Administration and other partners to make it easier for individuals to enter careers in nursing homes, investing over $75 million in financial incentives, such as scholarships and tuition reimbursement. This staffing campaign builds on other actions by HHS and the Department of Labor to build the nursing workforce.

More than 500,000 direct care workers provide care in nursing homes, assisting residents with daily tasks, such as bathing, dressing, mobility, and eating. This work, often performed primarily by women of color, is significantly undervalued. Direct care workers across long-term care settings earn low wages, rarely receive health and retirement benefits, and experience high injury rates. Improving working conditions and wages will lead to improvements in the recruitment and retention of direct care workers and enable nursing staff to provide safer care.  

CMS and the HHS Office of the Inspector General called for increased transparency and enhance enforcement of existing standards. This would result from increased audits of nursing homes’ staff, improving nursing  home inspections, oversight as to how nursing homes spend taxpayer dollars and cracking down on prescribing inappropriate antipsychotic drug prescribing practices.  The proposed rule would also undertake new efforts to improve resident safety during emergencies. 

Mandating more staffing during a severe labor shortage – pushback on an unfunded mandate

“It is unfathomable that the Biden administration is proceeding with this federal staffing mandate proposal. Especially when just days ago, we learned that CMS’ own study found that there is no single staffing level that would guarantee quality care, says Mark Parkinson, President and CEO of the American Health Care Association, a national nursing home trade group representing 14,000 nursing homes and other long-term care facilities across the nation taking care of five million residents each year.

“At the very same time, nursing homes are facing the worst labor shortage in our sector’s history, and seniors’ access to care is under threat. This unfunded mandate, which will cost billions of dollars each year, will worsen this growing crisis, warns Parkinson, noting that the proposed rule requires nursing homes to hire tens of thousands of nurses that are simply not there and then penalizes the facilities and threatens to displace hundreds of thousands of residents.

“Already, hundreds of nursing homes across the U.S. have closed because of a lack of workers,” states Parkinson. 

​John E. Gage, President, and CEO of the Rhode Island Health Care Association, with offices in Warwick, agrees with Parkinson’s assessment of the harm such proposals will trigger and its devastating impact on nursing homes and residents. “The federal staffing proposal is unfunded and is being implemented at a time when additional staff is simply not available,” he said.  

According to Gage, six Rhode Island-based facilities have closed since the beginning of the pandemic in March 2020. Three others are currently in receivership. Arbitrary federal staffing mandates will result in more closures, and residents will be displaced from their homes just as they were most recently when Charlesgate Nursing Center in Providence was forced to close because of skyrocketing costs, a scarcity of staff and chronically inadequate Medicaid funding. 

Unintended consequences of mandating minimum staffing

James Nyberg, president, and CEO of LeadingAge Rhode Island, with offices in East Providence, views see a staffing ratio mandate as a blunt enforcement instrument that does not consider the numerous challenges facing providers, including Medicaid underfunding, lack of workforce, and the diversity of resident needs. Moreover, the imposition of severe financial penalties on homes that are unable to meet a staffing ratio is counterproductive: fines siphon off scarce resources that providers need as they seek to address their workforce and resident care needs,” he says. 

“Our state’s experience illustrates the numerous challenges and unintended consequences of a staffing ratio mandate: the severity of fines, how compliance is measured and calculated, compliance costs, backlogs of people in hospitals waiting for skilled nursing care after admissions have been reduced due to a lack of staff and other access-related issues,” notes Nyberg, noting that even those homes that are currently able to comply with the staffing ratio are doing so at an unsustainable cost. 

While Kathleen Heren, executive director of the Alliance for Better Long-Term Care and the state’s Long-Term Care Ombudsman, supports HHS’s minimum staffing standard, the administration must adequately fund to train recruited workers and to pay a livable wage to retain them. “Rhode Island doesn’t have an issue with its nursing home inspection process as other states do, she says, noting that newly hired RI Department of Health surveyors are “doing a great job.” 

“RIDOH surveyors only cite facilities, when necessary,” says Heren, noting that administrators can challenge any cited deficiency if they view it as unfair, and she doesn’t see a problem in the use of antipsychotic medications in Rhode Island facilities “but acknowledges that there’s always room for improvement.”

Direct Caregivers, mainly women, undervalued despite significant work demands

“Almost 80 percent of nursing home care is paid for with government programs (Medicare and Medicaid), so it is hugely important that those dollars provide quality care,” says Maureen Maigret, chairperson of the aging in community subcommittee for the Long Term Care Coordinating Council.  She noted that studies show a clear relationship between staff levels and quality care but there is tremendous variation across the states in hours of direct care staff provided in nursing homes. 

“Rhode Island has required 24/7 RN staffing for many years and a 2021 state law requires minimum direct care staffing levels although implementation has been challenging due to the critical workforce shortage. Importantly, the proposed federal regulation would require states to report on compensation for workers as a percentage of Medicaid payments. For too long our direct care workers, mostly women, have been undervalued despite the significant demands of their work. It is time for them to receive a living wage and  shedding light on where our Medicaid dollars are going will help advocate for better wages helping to recruit and retain these essential workers,”  she says.

There will be a 60-day comment period for the notice of proposed rulemaking, and comments must be submitted to the Federal Register no later than November 6, 2023.  

For a copy of the federal register detailing CMS’s proposed rules on minimum staffing issued on Sept. 6, 2023, go to 

https://www.govinfo.gov/content/pkg/FR-2023-09-06/pdf/2023-18781.pd

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