Tag Archives for CMS

Wake up call on spiraling brand-name drug prices 

Published in RINewsToday on August 14, 2023

By Herb Weiss

A new pharmaceutical drug price report that is both timely and overdue has been released by AARP’s Public Policy Institute, following on the heels of the Centers for Medicare & Medicaid Services (CMS) releasing in June, which revised guidance for the historic Medicare Drug Price Negotiation Program.  

This report details the list prices for the 25 brand-name drugs with the highest total Medicare Part D spending in 2021, noting that prices have increased by an average of 226%—or more than tripled—since they first entered the market. Those 25 drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021, about 37% of the total spending, and were used by more than 10 million Part D enrollees.  It noted that, on average, nearly 60% of their current list price was due to price increases after the product entered the market.

The price of Enbrel, used to treat rheumatoid arthritis and psoriatic arthritis, has increased by 701% since coming to market in 1998, and the price of Januvia, used to treat diabetes, has increased by 275% since entering the market in 2006.

Overall, the lifetime price increases ranged from 20% to 739%, and all but one of the drugs’ lifetime price increases greatly exceeded the annual rate of inflation over the same period of time. 

Brand-name drug prices increase faster than inflation has – for decades

“Brand-name drug prices have increased dramatically faster than inflation for decades,” said Leigh Purvis, Prescription Drug Policy Principal, AARP Public Policy Institute, and author of the report.  “The median price of a new brand-name prescription drug is now approximately $200,000 per year, so even relatively small percentage price increases can translate into thousands of dollars and put life-saving medications out of reach of the patients who need them,” she said. 

“We know that there is lot of media attention on individual drug prices that take place year after year.  However, a lot less attention is paid to how those price increases are often building on top of a long line of price increases and how those relentless price increases add up over time,” says Purvis, during a press call to journalists scheduled on the day of the report’s release.

“These findings have huge implications for the people that AARP represents, many of whom need prescription drugs to help them stay well,” Purvis said. “People on Medicare prescription drug plans take on average of between 4 and 5 prescription drugs per month and their drugs are increasing covered using coinsurance where you pay a percentage of the drugs price instead of a flat co-pay.  In fact, across the country more and more people are facing cost sharing directly affected by drug price increases, whether it is by coinsurance or simply before they meet their deductible.  Millions of other people don’t have health coverage and are having to absorb the cost associated with growing drug prices on their own,” she said.

“Our analysis shows that drugs that have been on the market for twenty years or more have seen an average lifetime price increase of 592 percent.  In real terms this can be the difference of thousands of dollars for one person and enough to force the trade-offs that we often hear about, like choosing to put food on the table or being able to pay for gas,” notes Purvis.

“There is no justification for drug companies to engage in these type of price increases every year they are on the market, particularly increases that are so much higher than the price increases for other goods and services,”  adds Purvis. 

CMS releases revised guidance for negotiating with drug manufacturers 

Congress recently passed the Inflation Reduction Act (IFA), a federal law requiring drug companies to pay a penalty to Medicare if their drug’s price increases faster than the rate of inflation. The law will also give Medicare the ability to negotiate lower drug prices with drug companies for the first time. CMS is expected to announce the first 10 drugs selected for negotiation by September 1st, and the negotiated prices will become available in 2026.

“This historic law cracks down on the big drug companies and [will bring] real relief to millions of seniors who have been struggling with out-of-control prescription drug prices,” said Nancy LeaMond, AARP Executive Vice President and Chief Advocacy and Engagement Officer. “American families simply can’t afford to keep paying the highest prices in the world for the medications they need.”

Last March, CMS issued initial guidance to seek comments on its historic Medicare Drug Negotiation Program.  The agency received over 7,500 comments from consumer, patient groups, drug companies and pharmacies.  In June, CMS released its revised guidelines detailing the requirements and parameters of how the agency will oversee the new program.

“Issuing final guidance for the Medicare Drug Price Negotiation Program is an important “next step” in controlling spiraling high drug prices, says AARP’s LeaMond, noting that Medicare’s new buying power will get a better price for Medicare beneficiaries, saving the program billions of dollars and making prescription drugs more affordable.

Opposition, of course

At press time, the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry lobby group for pharmaceutical companies, along with a group of pharmaceutical companies and trade groups, are suing the U.S. Health and Human Services to block the implementation of the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act enacted by President Biden last August. The U.S. Chamber of Commerce has also filed a lawsuit in a U.S. District Court in Ohio to ask for an injunction to keep the negotiations from going forward. The trade group is challenging the constitutionality of the IFA’s drug price negotiation program.   

It’s a very high lift and big burden to meet the standard to stop the law from being implemented,” noted Kelly Bagby, AARP’s Vice President at AARP Foundation Litigation, before AARP’s press call ended.

“It is entirely appropriate and is necessary and the public interest is so enormous in balancing of the government’s interest verses the pharmaceutical companies and Chamber’s interest in this case,” says Bagby,” stressing that beneficiaries have to win this case. “It’s so obvious that pharmaceutical companies are not the victims they are painting themselves to be, she adds, affirming her belief that beneficiaries and Medicare have the strongest argument.  

Bagby noted, “AARP is working to protect the integrity of whole Medicare program for everybody and to allow for older people to not have to make horrible choices about do I pay my rent or do I get to take my life saving drugs.” 

Reports a Wake-Up Call

Although PhRMA,  pharmaceutical companies and trade groups along with the U.S. Chamber are strongly opposed to CMS’s new program to negotiation drug prices, polls show that people aged 50 and over, view the lowering of the price of costly prescription drugs to be a very important policy issue to them. Purvis hopes that the recently released AARP report will serve as a wake-up call for every American who is skeptical about the importance of lowering prescription drug prices. “Higher government spending driven by drug price increases will affect all Americans in the form of higher taxes, cuts to public programs, or both,” she predicts.  

For a copy of AARP’s Medicare Part D Drug Price report, go to https://www.aarp.org/pri/topics/health/prescription-drugs/prices-top-medicare-part-d-drugs-tripled-since-entering-market.html.

Nursing home workforce crisis deepens with minimum staffing standards

Published in RINewsToday on February 13, 2023

“The long-term care industry is enduring the worst workforce crisis in its history, in Rhode Island, and across the country. Although providers are committed to recruiting and retaining staff to provide quality care for residents, despite our best efforts, many nursing homes have fallen short of the staffing ratio set by the RI Department of Health,” notes James Nyberg, Executive Director of the East Providence-based Leading Age Rhode Island (LARI), representing nonprofit providers of aging services.

“We are extremely  concerned about the impending fines that will be imposed on nursing homes here in Rhode Island as a result of our state’s existing nursing home minimum staffing ratio statute,” said Nyberg. Because of staffing ratio mandates, “the industry would have faced fines of over $11 million, in just one sample quarter (April – June 2022), since over 70% of nursing homes are not in compliance,” he said.  

“While April-June was a sample, the fines go into effect for July-September and we will receive a similar notice in just a few weeks, with only 10 days to pay the fine,” says Nyberg, stressing that these fines will only increase going forward if nursing homes are unable to meet the minimum staffing ratio.

Nyberg calls on the Rhode Island General Assembly to rescue Rhode Island’s nursing homes and provide relief from these penalties by delaying them and exploring an alternative approach to support the efforts of nursing homes to meet the ratio.  He warns that the current fine-based approach is excessive and counterproductive and will lead to reduced access to care and threaten the survival of the state’s nursing homes.

Nyberg points out that the current workforce shortages are already preventing nursing homes from filling open positions, limiting new admissions, and forcing organization closures (five nursing homes have already closed since the COVID pandemic began).  These challenges are also resulting in backlogs at hospitals, which are unable to discharge patients due to reduced capacity in nursing homes.  

“We are working with numerous stakeholders on various initiatives to develop a pipeline of workers, but the simple fact is that it will take time.  In addition, as you know, the industry has faced years of underfunding from Medicaid, which pays for the majority of nursing home care.  This has made recruiting and retaining workers more difficult than ever,” says Nyberg. 

John Gage, President of the Rhode Island Health Care Association (RIHCA) agrees with Nyberg’s assessment of the nursing home workforce.  “Nursing homes across the nation are facing an historic labor shortage as the direct result of chronic Medicaid underfunding and the devastating impact of the Covid-19 pandemic on the workforce, he says, noting that the state’s nursing home workforce is down 20% since the start of the pandemic, with 2,000 workers lost from Jan. 2020 to June 2022.  Nationwide, the nursing home workforce is down 210,000 workers.

According to Gage, Rhode Island’s staffing mandate, while well-intentioned, will siphon tens of millions of dollars from resident care. In the first year of full implementation of the state’s minimum staffing mandate, RIHCA estimates that facilities will be fined upwards of $60 million. “These fines will imperil care, not bolster it,” he warns.  

Without legislative action, Rhode Island nursing homes will be fined an estimated $11 million on or about February 28, 2023, because of their inability to attract workers to meet the mandate from July 1, 2022, through September 30, 2022, Gage charges. “There are simply not enough available workers to fill the open staff positions, and resources are scarce.  Nursing homes will be devastated by these fines.  Facilities will reduce admissions, backing up hospital referrals and clogging hospital beds.  More nursing facilities will close – five have already closed since the beginning of the pandemic,” he predicts.  

Gage asks, “Who will care for Rhode Island’s frailest elders?” To recreate a minimum staffing mandate in nursing homes on the federal level would be a huge mistake, especially given the historic workforce crisis here in Rhode Island and nationwide,” he says.  

Gage’s comments echo concerns expressed by another group of US Senators in Jan. 20 correspondence (https://www.tester.senate.gov/wp-content/uploads/1-20-23-Nursing-Home-Staffing-Mandate-Letter-FINAL.pdf) sent to CMS by Senators John Bourasso, Jon Tester, and eleven other US Senators.  They caution the agency that a one-size fits all mandate would undermine access to care for patients, and they encouraged CMS to work with Congress on tailored solutions that address the workforce challenges facing nursing facilities.

At the federal level

Just days ago, U.S. Senators Bob Casey (D-PA), Chairman of the Senate Committee on Aging, and Ron Wyden (D-OR), Chairman of the Senate Finance Committee, called on the Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to encourage the federal agency to establish minimum staffing standards in nursing homes to ensure high-quality care for nursing home residents. In Feb. 10 correspondence, Casey and Wyden, along with Senators Sherrod Brown (D-OH), Kirsten Gillibrand (D-NY), Richard Blumenthal (D-CT), Cory Booker (D-NJ), and Elizabeth Warren (D-MA) urged CMS to advance the agency’s ongoing study to determine adequate staffing requirements in nursing homes.

“We appreciate the work that CMS has undertaken to promote safety and quality in nursing homes and applaud the Biden-Harris Administration’s commitment to protecting our nation’s seniors,” said the senators in Feb. 10 correspondence, urging CMS to “bring this work to completion.” 

“In our view, that means continuing the agency’s ongoing study to determine the level of staffing that is necessary to ensure safe and high-quality care for nursing home residents, developing an evidence-based and actionable proposal for mandatory minimum staffing levels, and a robust and transparent process—including direct stakeholder engagement— that will allow for further discussion and fine-tuning of requirements before the proposal is finalized,” wrote the senators.

The senators noted that studies have shown a correlation between inadequate staffing levels and lower quality of care. More recent studies have demonstrated that higher nurse staffing ratios mitigated the effect of COVID-19 outbreaks in nursing homes and resulted in fewer deaths. A recent Department of Health and Human Services Office of Inspector General report examining the high level of COVID-19 infections in nursing homes also pointed to the need for the establishment of minimum staffing requirements.  

In the correspondence, the senators cite the Social Security Act, which requires skilled nursing facilities to “provide 24-hour licensed nursing service which is sufficient to meet nursing needs of its residents,” including the services of a registered nurse at least 8 consecutive hours per day, 7 days a week. The letter commends CMS for working to update this vague standard that has led to substantial variation in staffing levels and quality of patient care across facilities.

“Achieving the shared goal of ensuring quality care in nursing homes nationwide is a complex undertaking, says LeadingAge’s Ruth Katz, senior vice president, policy. LeadingAge is an association of nonprofit providers of aging services, including nursing homes.

“As our Get Real on Ratios proposal highlights, a number of conditions must be met in advance of any mandate implementation,” suggests Katz. “The senators correspondence to CMS is a promising development; it covers many of the same points as our Get Real on Ratios proposal – a recognition of the critical need for adequate reimbursement; that one size does not fit all, and that workforce shortages will need to be addressed with additional support. Without addressing these, staffing mandates are impossible. We look forward to continuing our discussions with Congressional leaders on this critical issue so that older adults and families can access much-needed care and services,” she says.

“The Senior Agenda Coalition of RI fully supports the need to develop national staffing standards to ensure quality care is provided to nursing home residents across our nation. It is important to note that Rhode Island has been a leader in this area. For many years our state has required 24/7 RN coverage in nursing homes and in 2021 the legislature passed the Nursing Home Staffing and Quality Care Act that includes staffing standards,” says Maureen Maigret, Policy Advisor to Senior Agenda Coalition of RI. “Now we must work to address workforce shortage issues and ensure that adequate government resources are provided especially through Medicaid payments so the standards can be met, and our critical direct care workers receive competitive living wages in order to keep them working in long term care,” she adds.

As the House Leadership hammers out the FY 2024 budget, it is crucial that adequate Medicaid funding is allocated to allow nursing homes to attract the necessary staff to meet the state’s minimum nursing standards that it codified into law. We must address this policy problem now rather than just kick the can down the road.

CMS Moves to Strengthen Nursing Home Safety and Clarity of Consumer Info

Published in RINewsToday on January 23, 2023

To improve transparency of nursing home consumer information, the federal Department of Health and Human Services (HHS) through the Centers for Medicare & Medicaid Services (CMS), will now post Care Compare citations that are under dispute by nursing homes on its website.  CMS will also take steps to protect nursing home residents from being inappropriately diagnosed with schizophrenia which oftentimes leads to improper use of anti-psychotic medications to sedate and chemically restrain residents.

“We have made significant progress in decreasing the inappropriate use of antipsychotic medications in nursing homes, but more needs to be done,” said CMS Administrator Chiquita Brooks-LaSure, announcing the new guidance this week. “People in nursing homes deserve safe, high-quality care, and we are redoubling our oversight efforts to make sure that facilities are not prescribing unnecessary medications,” she says.

CMS’s actions advance President Biden’s goal of reinforcing safeguards against unnecessary medication use and treatments that was outlined in his State of the Union address to create an Action Plan for “Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes.”

Tackling the inappropriate drugging of Nursing Home residents

Beginning this month, CMS will conduct targeted, off-site audits of nursing homes to determine whether facilities are accurately assessing and coding individuals with a schizophrenia diagnosis. Nursing home residents erroneously diagnosed with schizophrenia are at risk of receiving poor care and being prescribed inappropriate anti-psychotic medications. Anti-psychotic medications are especially dangerous to these residents due to their potential devastating side effects, including death.

According to the Washington, DC-based National Consumer Voice for Quality Long-Term Care, in 2008, CMS first introduced a quality measure in its Care Compare rating system that calculates the percentage of long-stay residents (over 100 days) that were receiving anti-psychotic medications. This quality measure was initially introduced to address the practice of some nursing homes of illegally using anti-psychotic medications to sedate residents with dementia or other increased patient care needs, rather than providing appropriate hands-on care interventions.

The measure, excluding residents with certain diagnoses, including schizophrenia, Huntington’s disease, and Tourette’s syndrome, resulted in some nursing homes improperly diagnosing residents with schizophrenia, observed the Consumer Voice, a national organization representing consumers in issues related to long-term care, helping to ensure consumers are empowered to advocate for themselves.      

CMS’s new guidance acknowledges that there has been a steady rise in schizophrenia diagnoses since the quality measure was first introduced, charges the Consumer Voice, noting that it comes on the heels of a report issued by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) which found that from 2015-2019 there was a 194% increase in the number of residents diagnosed with schizophrenia who did not have that diagnosis prior to admission to the nursing home.

“It is important to note that it is extremely rare for schizophrenia to suddenly occur in older people,” says the Consumer Voice, stating that the onset of schizophrenia generally occurs in someone’s late teens through their twenties.

CMS announced that it will begin to conduct audits of nursing homes with high rates of schizophrenia diagnoses and “examine the facility’s evidence for appropriately documenting, assessing, and coding a diagnosis of schizophrenia.” Facilities that have “inaccuracies” will have their Five-Star Quality Measure Rating adjusted. CMS will downgrade the facility’s Quality Measure ratings to one star, which would drop their Overall Star Rating as well. CMS will monitor each facility’s data to determine whether they have addressed the identified issues. After that, CMS will decide whether any downgrades should be reversed.

While Consumer Voice has expressed significant concern with the accuracy of CMS’s Quality Measure, it supports these actions. The Quality Measure rating often inflates a facility’s overall 5-Star rating on Care Compare. This action will help incentivize compliance and make sure the public is aware of these illegal practices in nursing homes, says the consumer advocacy group.

Increased transparency

Separately, CMS announced it plans to take a new step to increase the transparency of nursing home information provided to consumers by publicly displaying survey citations that facilities are disputing. Currently, when a facility disputes a survey deficiency, that deficiency is not posted to Care Compare until the dispute process is complete. This process usually takes approximately 60 days; however, some cases can take longer. 

Although the number of actual deficiencies under dispute is relatively small, they can include severe instances of non-compliance such as Immediate Jeopardy (IJ) citations. This level of citation occurs when the health and safety of residents could be at risk for serious injury, serious harm, serious impairment, or death. Displaying this information while it is under dispute can help consumers make more informed choices when it comes to evaluating and choosing a facility. This new information will begin appearing on Care Compare on January 25th. While citations will be publicly displayed, they will not be included in the Five-Star Quality Rating calculation until the dispute is complete. 

“We support anything that CMS can reasonably do to improve the health and safety of seniors in long-term care, especially those with cognitive impairment. When it comes to the nursing home industry’s concerns about new CMS rules, we think it’s best to err on the side of transparency. Seniors and their families need as much information as possible to make informed decisions about long-term care,” says a spokesperson for the Washington, DC-based National Committee to Preserve Social Security and Medicare, an advocacy group whose mission is to protect Social Security and Medicare.

Local reaction:  “You cannot un-ring a bell”

RI Health Care Association

“We fully support improving nursing home transparency, safety and quality, and accountability regarding our members’ service to the residents and patients entrusted to their care,” says John E. Gage, President and CEO of Rhode Island’s Health Care Association, representing 64 of the 80 nursing facilities in the state. “Eliminating any inappropriate use of psychotropic medications and ensuring the highest quality of care is a shared focus of both CMS and RIHCA,” notes Gage.

“We strongly disagree with CMS’ decision to post of deficiencies that are in the process of being disputed through established CMS policies, regardless of their scope and severity, says Gage. “Posting deficiencies that, in many instances, are incorrect, inaccurately cited or cited at an inappropriate level of scope and severity, during an approved appeals process is unfair and could damage a facility’s reputation unfairly,” he adds.

According to Gage, doing this is akin to convicting someone before their full trial, (prosecution and defense alike) before the verdict is announced. “You cannot “un-ring a bell,” he says.

“As mentioned by CMS, we are just talking about a relatively small number of deficiencies,” states Gage. Rather than potentially posting erroneous deficiencies, he calls on CMS to speed up the process of conducting Informal Dispute Resolutions (IDRs) or Independent Dispute Resolutions (IIDRs) to no more than forty-five (45) days to ensure that accurate information is posted timely. IDRs and IIDRs are two different options from CMS that nursing homes can choose to appeal of cited deficiencies.

“As to the changes to the public reporting and the Five-Star Quality Rating System, we are disappointed that the Biden Administration and CMS have apparently made this determination administratively, without any comment period to allow for an opportunity for nursing homes and the public to provide feedback,” says Gage.

LeadingAge RI

“I appreciate CMS’s goal of increasing oversight of unnecessary antipsychotic medication use, although it should be noted that there has been a National Partnership to reduce the unnecessary use of antipsychotic drugs for years, so the industry has been very engaged in these efforts already,” notes James Nyberg, Executive Director of LeadingAge RI, a not-for-profit membership organization comprised of not-for-profit providers of aging services. 

Nyberg expresses concern about CMS posting deficiencies that are under dispute publicly. “That is taking a guilty before proven innocent approach, which is unfair and detrimental to providers. There is an existing process to resolve disputes over deficiencies, and this seems to short-circuit it, especially when deficiencies can be/and are overturned during the process.  One more blow to a beleaguered industry,” he says.

Long-Term Care Ombudsman

“The inappropriate use of antipsychotic medications in nursing homes has been an on ongoing issue for many years,” observes Kathleen Heren, Rhode Island’s Long-Term Care Ombudsman. “It takes a skilled practitioner who gives a battery of tests to diagnose someone with schizophrenia. This shouldn’t be determined by a hospital intern who spends 20 minutes with an agitated resident in a hospital emergency room,” she says.

According to Heren, schizophrenia has an early onset [about 4% of schizophrenia arise before the age of 15, and about 1% before the age of 10].  A 78-year -old resident does not become schizophrenic all of a sudden because he or she is agitated. “I can say that I have not seen many deficiencies given to Rhode Island nursing homes for overusing anti-psychotic medications,” she says, because of the efforts of  Health Care Centrics, Rhode Island’s Quality Assurance organization, that has provided in-depth staff training on the use of these drugs. The surveyors from the Rhode Island Department of Health (RIDoH) are very quick to cite facilities for not following guidelines in the inappropriate use of these drugs.

Heren says that there have been cases where RIDOH has rescinded a deficiency based on the input received by the survey team during the Informal Dispute Resolution process. “There are some facilities that are continually receiving deficiencies and that families should be able to see why a deficiency was given and a facilities response as to why it was considered unfair,” she says.

CMS Actions promote quality of care

RI Department of Health

“At the Rhode Island Department of Health (RIDoH), one of our major focus areas is monitoring and ensuring that nursing homes and other healthcare facilities provide the highest quality of care and services in a clean and safe environment, says Joseph Wendelken, RIDoH’s Public Information Officer. 

“We will continue to do everything we can to protect patients and residents, which includes following any new CMS protocols and partnering with CMS on new initiatives,” Wendelken says. 

Senior Agenda Coalition of RI

Adds Maureen Maigret, Policy Advisor for the Senior Agenda Coalition of RI, “Rhode Island nursing homes have generally provided good quality of care over the years,” acknowledging that improvements can always be made. “Both of these changes are intended to promote better quality care,” she says. “If people are erroneously coded as having schizophrenia, they may be subject to poorer care and harmed by being prescribed inappropriate medication. Posting inspection citations under dispute on Nursing Home Compare with a notation they are under dispute is important in that resolution of the dispute could take 60 days or longer and in the meantime the public remains unaware of what could be significant deficiencies which could impact their decisions,” states Maigret says.

The QSO memo — Updates to the Nursing Home Care Compare website and Five-Star Quality Rating System: Adjusting Quality Measure Ratings Based on Erroneous Schizophrenia Coding, and Posting Citations Under Dispute — is available here for review:

https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-states/updates-nursing-home-care-compare-website-and-five-star-quality-rating-system-adjusting-quality