Tag Archives for HHS

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

Medicare to negotiate select drug prices with Big Pharma, lists first 10 drugs

Published in RINewsToday on September 4, 2023

While critics are attempting to go through the courts to put the brakes on allowing Medicare to negotiate and set drug prices, last week, the Biden administration announced its list of 10 drugs that will be subject to price negotiations mandated by the Inflation Reduction Act (IRA).  

Earlier this month, more than 70 groups and a petition signed by 150,000 individuals called on Merck & Co., Bristol Myers Squibb Company, Janssen Pharmaceuticals, Astellas Pharma US, Pharmaceutical Research and Manufacturers of America (PhRMA) and the U.S. Chamber of Commerce, to drop their lawsuits to block the drug price negotiation provisions from taking place, and several organizations filed an amicus brief in support of the Biden administration’s historic law. 

With President Biden signing the IRA into law in Aug. 2022, the Centers for Medicare and Medicaid Services (CMS) began hammering out the regulations by issuing on March 15, 2023 its initial guidance for its Medicare Drug Price Negotiation Program. At that time, CMS had received over 7,500 comments on its initial guidance from consumer and patient groups, drug companies and pharmacies.  On June 30, 2023, the federal agency released its revised guidance detailing the requirements and parameters for the program. With the publishing of the listing of 10 drugs on August 29, 2023, for the first time, Medicare is now able to move forward in negotiating prices directly with drug companies, with the goal of lowering prices on some of the costliest prescription drugs. 

According to CMS, the selected 10 drugs accounted for $50.5 billion in total Part D gross covered prescription drug costs, or about 20%, of total Part D gross covered prescription drug costs between June 1, 2022, and May 31, 2023, which is the time period used to determine which drugs were eligible for negotiation. The negotiations with participating drug companies begin now until 2024, and any negotiated prices will become effective beginning in 2026. Medicare beneficiaries taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs.

It’s a Long Wait…Lower Prices to Take Effect Jan. 2026

CMS will publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024; those prices will come into effect starting January 1, 2026. In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the IRA.  CMS will provide opportunities for public comment at patient-focused listening sessions in Fall 2023.

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs,” says Secretary Xavier Becerra, of the U.S. Department of Health and Human Services (HHS). “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred,” she pledges. 

With the announcement of the first drugs selected for Medicare drug price negotiation, CMS Administrator Chiquita Brooks-LaSure noted it marked a significant and historic moment for the Medicare program. ”Our goal with these negotiations is to improve access to some of the costliest drugs for millions of people with Medicare while driving competition and innovation,” she said.

Adds Meena Seshamani, MD, PhD, CMS’s Deputy Administrator and Director of the Center for Medicare, “Promoting transparency and engagement continue to be at the core of how we are implementing the new drug law and the Medicare Drug Price Negotiation Program, and that is why we set out a process for the first round of negotiation that engages the public throughout.” 

“No one should have to choose between paying for lifesaving medication and other basic necessities, like food and housing,” says Rep. Seth Magaziner, representing Rhode Island’s Congressional District 2.  Nearly 191,000 Rhode Islanders are enrolled in Medicare Part D and could be eligible for cost savings that results from CMS’s negotiating with drug makers, he says, noting that.  Rhode Island seniors paid an average of $6,022 in out-of-pocket costs per year for one of the drugs selected for Medicare Price Negotiations.  These drugs are used to treat some of the most common diseases like diabetes, heart disease, arthritis, blood clots, and cancers.   

But PhRMA and U.S. Chamber of Commerce express strong concerns over imposing government price controls on the price of medications.  

CMS’s release of 10 drugs selected for negotiation “is the result of a rushed process focused on short-term political gain rather than what is best for patients,” says PhRMA) President and CEO Stephen J. Ubl. “Many of the medicines selected for price setting already have significant rebates and discounts due to the robust private market negotiation that occurs in the Part D program today,” he claims.

“Giving a single government agency the power to arbitrarily set the price of medicines with little accountability, oversight or input from patients and their doctors will have significant negative consequences long after this administration is gone,” warns Ubl.

Furthermore, “insurance companies and their Pharmacy Benefit Managers may further restrict access to medicines through increased utilization management, higher copays and more restrictive formularies, notes Ubl.

USCoC also expresses strong concerns over HHS’s move to impose government price controls on medications. While USCoC is supportive of affordable medications, it warns that an implementing government price controls scheme is both “counterproductive and will restrict access to critical medicines, delay treatment for patients, and jeopardize the search for new lifesaving cures,” says Executive Vice President and Chief Policy Officer Neil Bradley. 

“In its rush to implement the IRA’s price control scheme, the Biden administration failed to examine the likely negative side effects of the policy, charges Bradley.

Celebrating a Sweet Victory

“The negotiated drugs list is a watershed moment for medicine affordability. Drug corporations pretend this is a catastrophe, but I would rather see that money in seniors’ pockets than Big Pharma’s,”  says Peter Maybarduk, director of the Access to Medicines program at Public Citizen

“Drug corporations, in crude arrogance, are suing to limit price negotiations under the IRA. But the list shows instead how important it is to expand those negotiation powers. Several monopolized drugs that are expensive for Medicare today are exempted from price negotiation, and will remain expensive,” predicts Maybarduk, explaining that for a many-years long grace period after a drug first comes to market. “During those years, drug makers will exploit patent monopolies with minimal checks on profiteering. That profiteering period is even longer for biologics, which comprise some of the most exorbitantly priced drugs,” he says. 

“This is an historic day in the effort to lower prescription drug prices for seniors.  The Biden administration has released the names of the 10 life-saving drugs that will be subject — for the first time ever — to price negotiation between Medicare and Big Pharma,” stated Max Richtman, President and CEO, National Committee to Preserve Social Security and Medicare.

According to Richtman, the Inflation Reduction Act provides for this reform, in addition to a $2,000 out-of-pocket cap for patients’ Medicare Part D drug costs and penalties for drug-makers who hike prices above the rate of inflation. Medicare price negotiation alone is expected to save seniors and taxpayers billions of dollars in drug costs over next the decade.

“This is a sea change in the government’s ability to lower prescription drug prices for older Americans, who all too often are compelled to ration medications or forgo filling prescriptions because of soaring costs. NCPSSM has fought for Medicare to be empowered to negotiate prices for some twenty years now,” adds Richtman., noting that the next step is to enlarge the number and type of medications subject to negotiation, to deliver maximum relief to seniors on fixed incomes.   

“Allowing Medicare to negotiate prices for these first 10 drugs will finally bring much needed access and relief to American families, particularly older adults. We cannot overstate how monumental this law is for older Americans’ financial stability and overall health, said AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond. 

“The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore. AARP will keep fighting to protect Medicare negotiation from any efforts to undo or weaken it, so all older Americans can afford their lifesaving medicines,” Says LeaMond.

And Alex Lawson, Executive Director of Social Security Works, says CMS’s listing of 10 drugs are among the most outrageously priced drugs on the market, calling these drugs, “Pharma’s prized cash cows.”

“This is just the beginning,” says Lawson, predicting that within a decade, Medicare will have the power to negotiate lower prices on well over 100 drugs. “That’s a huge win for seniors and people with disabilities,” she adds, noting that it is the biggest legislative defeat Big Pharma has ever suffered – and it won’t be the last.

Final Note…

Vincent Marzullo, who serves on the Board of the Senior Agenda Coalition of RI as well as a member of Congressman Magaziner’s Senior Advisory Committee, says that despite CMS’s  announcement of the 10 drugs to be negotiated, consumers won’t realize a penny in savings until January 2026, 28 months from now. “Unfortunately, urgency seems not to be a feature of the Inflation Reduction Act at least when we will get lower priced prescriptions,” he says.

View a fact sheet from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at: https://aspe.hhs.gov/sites/default/files/documents/705b9c384d493e442a1d4004905cf8ae/ASPE-IRA-Drug-Negotiation-Fact-Sheet.pdf.

More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.