Health advocacy groups oppose groups against drug price negotiations

Published in RINewsToday on August 21, 2023

As supporters of President Biden’s Inflation Reduction Act (IRA) celebrate the one-year anniversary of the passage of this historic legislation, health advocacy groups gathered last week in Austin, Texas, Washington, D.C., Chicago and New York City to publicly oppose and call on the U.S. Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PhRMA) along with drugmakers to withdraw their lawsuits to block the IRA’s drug price negotiation provisions.  They instead called for the immediate lowering of the prices of brand-name pharmaceuticals.

At press time, Merck & Co., Bristol Myers Squibb Company, Janssen Pharmaceuticals, Astellas Pharma US, PhaRMA, and the U.S. Chamber of Commerce have filed lawsuits arguing that the price negotiation program is unconstitutional and violates the Constitution’s 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 charge that the Centers for Medicare & Medicaid Services’ (CMS) price controls would force drug manufacturers to pull back on developing new drugs, jeopardizing medical breakthroughs for individuals with life-threatening and chronic illnesses.

The filed legal suits come weeks before Sept. 1 when CMS is scheduled to publish a list of the first 10 drugs that will be subject to negotiations. By Oct. 1, the drug companies must declare whether they will participate in negotiations or face steep financial penalties for not negotiating. The lower negotiated prices will not take effect until 2026.

Public Citizen, a Washington, DC-based nonprofit consumer advocacy group along with other health care advocacy groups including Patients for Affordable Drugs Now, Protect Our Care, Families USA and Doctors for America and AARP and the AARP Foundation have filed amicus briefs supporting HHS’ position that the motion for a preliminary injunction requested by the Chamber and the other plaintiffs in that case should be denied.

At the Washington, D.C. press conference, Robert Weissmanpresident of Public Citizen delivered a petition signed by 150,000 individuals to the U.S. Chamber of Commerce demanding that all court suits be dropped. 

Public Citizen, Social Security Works, and more than 70 health and consumer organizations also sent letters to the prescription drug corporations, demanding those corporations drop their lawsuits and begin negotiating lower drug prices.  The letter cited how drug corporations routinely charge Medicare beneficiaries in the United States twice or more of what they charge patients in other large, wealthy countries – even in cases where U.S. taxpayers supported the drug’s development.

“It’s a disgrace that the U.S. Chamber of Commerce is fronting for Big Pharma [against the interests of the mom-and-pop businesses it purports to represent,” said Robert Weissman. “Patients, small businesses, large businesses, state and local governments, and the federal government all have a shared interest in curtailing Big Pharma price gouging, as the Inflation Reduction Act’s drug price negotiation provisions will do.”

“The lawsuits filed by the large pharmaceutical corporations to overturn Medicare drug price negotiation authority demonstrates that there is no bottom to big pharma’s greed, charges Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare. “It isn’t enough that revenue to U.S. drug corporations was over $1 trillion in 2022.  It isn’t enough that big pharma benefits from the $54 billion spent in taxpayer dollars per year on pharmaceutical research. It isn’t enough that the 2017 Trump tax cut bill lowered average tax rates of the big pharmaceutical companies by more than 40 percent. It isn’t enough that pharma’s profit margin is 15 percent to 20 percent while the average profits of the nation’s largest 500 corporations ranged between 4 percent to 9 percent,” he says.   

“Americans have had enough of big pharma’s greed – and while I am sure the price gougers won’t stop putting profits before people – we urge the industry to drop this unconscionable lawsuit against the authority to negotiate prescription drug prices,” he adds.

“Big drug companies and their allies are fighting furiously to stop Medicare from negotiating drug prices so they can keep charging Americans the highest prices in the world. Allowing these distractions to derail implementation of the law would not be in the public’s interest, especially for older adults who have waited far too long for affordable drug prices. Medicare drug price negotiation represents a historic opportunity to access lifesaving drugs for millions of Americans at a time when they need them the most,” said William Alvarado Rivera, Sr. VP for Litigation at AARP Foundation.

“Pharmaceutical corporations have long shown that they care about nothing but profits. So, it is not surprising that they are attempting to use the courts to subvert the will of the people and block Medicare from using its bulk purchasing power to get better prices,” said Alex Lawson, executive director of Social Security Works“The law is incredibly clear, as is the will of the American people: Medicare drug price negotiations are legal and incredibly popular. Everybody wins except the greedy CEOs who see their drug price extortion rackets shut down.”

Protests Call for the Immediate Dropping of Court Suits 

On Aug. 16, 2023, in Washington, D.C., the “Drop Your Suits, Drop Your Prices,” a press conference/rally was held outside the headquarters of the U.S. Chamber of Commerce in Washington, D.C., and in New York City outside of the offices of Jones Day, and outside the Federal Courthouse in Austin where some of the drug makers are launching their legal attacks on Medicare, and at the offices of Astellas in Chicago.

At the Washington, DC press conference, a digital billboard advertising on a parked box truck set the stage for the event. In big bold red and gold letters the message read: “The Chamber of Commerce and Big Pharma are suing to keep your drug prices high.  They must drop their lawsuits and lower drug prices.”

Public Citizen’s Weissman kicked off the noon time press conference, stating, the U.S. Chamber of Commerce claims to represent small businesses but these businesses are bearing the brunt of paying for the high price of drugs.  Because of this, 3 in 10 Americans are rationing their drugs, he says. 

Weissman asked why is the U. S Chamber of commerce opposing the interests of small and large businesses? He charges that the nation’s largest lobbying group for the nation’s businesses is “is shamefully fronting for Big Pharma and companies that have an interest in overturning this law” that requires Big Pharma to negotiate with Medicare on drug prices. “But we are here today to tell Big Pharma were not going to let you get away with it,” he says.

“We’re going to win. We’re going to win the in the courts. We’re going to win on the streets. This price negotiation is going to go forward. It’s the beginning not the end in getting big Pharma price gouging under control, making sure medicines are affordable for everyone who needs in this country,” predicts Weissman.

Like all the speakers, 22-year-old Jacqueline Garibay called on the U.S. Chamber of Commerce, PhaRMA, and the other pharmaceutical companies to immediately drop their lawsuits to lower drug prices.  She was diagnosed with Ankylosing Spondylitis, an autoimmune disorder that primarily affects her spine and has spread to most of her major joints. Without expensive biologic medications, Garibay’s spine could fuse and leave her unable to walk by the time she graduates from George Washington University.  

In the last four years since her diagnosis, doctors have put her on four biologic drugs, each one with a price tag ranging from $5,000 to $13,000 every month, trying to find one that will work for her.  There have been times when Garibay has had to forego refilling her prescriptions because of financial difficulties resulting from having to pay for her rent, groceries, and tuition at the same time. “It’s “absolutely terrifying,” she says, fearing that without taking these medications she will risk losing the ability to walk.  

“The new drug price reforms are projected to save patients like her tens of billions of dollars. “It will help me have a future I can afford, a future where I can pursue all my dreams without being financially undermined for the sake of my health condition,” she says.

Laura Marston, a 41-year-old diagnosed with Type 1 Diabetes over 27 years ago at age 14, has seen the price of her insulin soar from the price of a vial for $ 21 to over $300.  “No vial costs Eli Lilly less than $5 to make,” says the resident of Washington, D.C. 

Marston picked up her insulin prescription from the pharmacy a week ago. The price for a three-month supply of seven vials that will enable her to live was $ 2,267.99. “That’s immoral, that’s inhuman and that’s flat out wrong,” she said.

“My message to Eli Lilly, Novo Nordisk, Sanofi and the Chamber of Commerce is lower your insulin prices, or we will do it for you in the form of federal price caps legislation. The 7 million Americans who rely on insulin to level not-stop raising our voices until we no longer have to choose our money or our lives,” she says.

Arthur Blair, a patient advocate for Spaces in Action, described how a debilitating disease forced him to quick his job. What do you do when you don’t have money, not even enough to pay for high cost of drugs,” he asked. 

“Pharma has proven with this latest action [attempting to block the negotiation of drug prices] that they put unreasonable profits before the people. They don’t mind knowing that people are done because they are unable to obtain prescription drugs that would easily save their life and eliminate easier suffering,” charges Blair.

According to HHS, as of June 2021, about 48 million Medicare beneficiaries are currently enrolled in plans that provide the Medicare Part D drug benefit. Last year, Congress came together begin putting the brakes on spiraling drug costs by passing legislation that allows Medicare to negotiate for lower prices.  

Currently drug prices are higher in the U.S. than other countries because Medicare doesn’t negotiate prices with drug makers like other countries do. Because the practice of negotiating drug prices was banned in 2003 under the law that created the Medicare Part D prescription drug benefit, 77 percent of all Medicare beneficiaries pay more for prescription drugs than these nine countries — Austria, Australia, Belgium, Canada, Germany, Japan, Sweden, Switzerland and the United Kingdom (This was documented by a 2021 study of the Rand Corporation.) 

Although the “Drop Your Suits, Drop Your Prices” press conferences held around the nation drew small crowds, the importance of these gatherings is the message they sent to the nation, that is “It’s time to stop blocking a law that puts money into the pockets of seniors instead of the bank account of drug makers.”

To watch the https://www.youtube.com/watch?v=w_8WHFv7oL4

To read why the U.S. Chamber of Commerce is suing the U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services to challenge drug price negotiations, go to https://www.uschamber.com/lawsuits/why-were-suing-hhs-and-cms-to-challenge-illegal-price-controls.

To read an amicus brief submitted by Public Citizen, Patients for Affordable Drugs Now, Protect Our Care, Families U.S.A and Doctors for American, supporting HHS’s position that the motion for a  preliminary injunction requested by the Chamber and the other plaintiffs in that case should be denied, go to https://www.citizen.org/wp-content/uploads/35-1-Proposed-amicus-brief.pdf.

To read AARP and AARP Foundation’s full amicus brief, go to https://www.aarp.org/content/dam/aarp/aarp_foundation/2023/dayton-area-cha mber-of-commerce-v-becerra-brief.pdf.

House Study Commission could create first state plan on aging in Rhode Island

Published in RINewsToday on March 20, 2023

With oversight of the state’s aging programs and services scattered among state agencies charged with overseeing a fragmented long-term care (LTC) system, House Deputy Majority Leader Lauren Carson (D-District 75, Newport) tossed H 5224 into the legislative hopper. The bill calls for the creation of a Special Legislative Commission (to be referred to as House Study Commission), with 14 members, to study and provide recommendations to coordinate the state’s program and services provided to older residents.  The commission, charged with taking a comprehensive look at the funding, coordination and delivery of state agency programs and services to older Rhode Islanders, would be required to report its findings and recommendations to the House no later than Feb. 7, 2024, and it would expire on May 7, 2024.

According to House Communications Director Larry Berman, “Legislation to create commissions are requested when issues need greater study than just one hearing. Commissions usually consist of House members, along with experts in the field, who will meet on multiple occasions and then develop recommendations to the House.”

The Nuts and Bolts

The House Study Commission’s legislative charge would include making a comprehensive study of key statistics that includes compiling demographic and financial statistics, and health status of older Rhode Islanders, and taking a look at their strengths and vulnerabilities to enable them to stay in the community. It would assess federal, state and local programs available, examining duplication of services, and provide recommendations as to how to eliminate red tape and better coordinate services among state agencies to improve the delivery of programs and services.

Its final report would also review and provide recommendations for the funding of services through State, Federal, and private grants, and provide recommendations for more efficient distribution and use of these dollars. It would also include making recommendations for the creation of a portal to provide and coordinate aging programs and services in the areas of employment, education, independent living, accessibility, and advocacy, as well as local older adult centers and services. 

Also, recommendations would be provided on mental health, transportation, food access, and health care. The commission would also explore and provide recommendations for additional regionalization of services.

Aging Organizations and Advocates push for passage

Last week, the primary sponsor of H 5224, and supporters, testified before the House Health and Human Services (HHS) Committee to give their thoughts about the creation of a House Study Commission and its positive impact on the delivery of programs and services to older Rhode Islanders.

Carson, the primary sponsor, opened up the hearing on the legislation telling lawmakers that many programs for older Rhode Islanders fall in different places around the state. “Even professionals are having problems navigating the system, never mind family, friends and parents,” she says, referencing a conversation she had with a Director of a Newport-based Senior Center, discussing the challenges during the COVID pandemic to navigate the system at state-level, providing services to her older clients.

“If we look back over the last 20 years, we used to have a cabinet-level position on Aging, then we had a Division on Aging, and  now we have an Office on Aging,” says Carson, noting that we have an increasing amount of older people in Rhode Island. She called for lawmakers to return the Office of Healthy Aging at a cabinet-level.

By creating a House Study Commission, lawmakers can look in an organizational way at how programs are being offered to seniors,” says Carson.  

According to George Neubauer, Chair of the Senior Agenda Coalition of Rhode Island (SACRI), an advocacy coalition representing 21 organizations, told lawmakers that SACRI had called for candidates at its Gubernatorial forum held last August to create a Rhode Island Strategic Plan on Aging. This plan would help the state look at its infrastructure and coordination of services for its rapidly growing older population, he said. At this time Rhode Island has no such plan, he said. 

In his testimony, Neubauer stated: “While the purpose of this proposed House Study Commission does not specifically call for development of a state Strategic Plan on Aging, it does call for a comprehensive look at our older population. “It would be charged with providing recommendations of collaboration, coordination within agencies, funding of services, and recommendations in areas of importance to older adults’ needs and quality of life, he added.

 “A number of states have developed what are sometimes referred to as Master Plans on Aging (including California, Massachusetts and New York). A Master Plan could be a roadmap to help the state transform its infrastructure and coordinate services for its older persons.  The findings and recommendations of this study Commission could lead to development of such a plan for Rhode Island,” says Maureen Maigret, former Director of the Rhode Island Department of Elderly Affairs (now the Office of Healthy Aging) and Chair of the Aging in Community Subcommittee of the Long-Term Care Coordinating Council.

It is now time for the creation of the House Study Commission, says Vincent Marzullo, who served 31 years as a career federal civil rights and social justice administrator at the National Service Agency, and a well-known aging advocate. “For the first time in recorded history, there are more people over the age of 64 in the world, than children under five. In Rhode Island, over 31 percent of residents are age 55 or older, and by 2030 one-quarter of our population will be over 65,” he says.

“Don’t we now have an obligation to ensure better healthcare, safety, housing, livability, caregiving, etc. for this aging community?” asked Marzullo, noting that during the pandemic more than 90% of the deaths were individuals over 60 —- and 53% of overall deaths were congregate care residents.

“With the lessons learned over the past two years and the devastating impact of COVID on our older adults, it’s critical that we reexamine our aging infrastructure, the needs for services, and the local service capabilities to this growing population, adds Marzullo, calling for “a serious, adult conversation that is long overdue to take place with the aging community, service providers and lawmakers about designing our plan for a more ‘Age-Friendly’ RI, which supports local senior centers as the local hub for the delivery of services.”

Deborah Burton, Executive Director of RI Elder Info, said that enacting H 5224 is “an essential step” towards improving the lives of older Rhode Islanders. “By studying our current services and initiatives, identifying future needs, and identifying potential areas for improvement, we can ensure that all older adults in our state have access to the resources they need to achieve wellbeing and maintaining maximum independence in ways that value, empower and engage them,” she said.

Carmela Greer, Executive Director of Edward King House Senior Center, gave her views as to why it is important to establish a House Aging Commission authorized by H 5224. “This opportunity to document who does what, when, for whom, with what dollars is a common-sense approach to building a comprehensive cost-effective way to care for the other of our most vulnerable populations second only to children,” she said.

According to Greer, who also serves as Policy Committee Lead for the RI Senior Center Directors Association, once this policy road map is designed, “smart decisions can be made to establish where the money can be saved, where duplication can be eliminated, and where existing funding can be re-directed, where duplication can be eliminated, and where existing funding can be re-directed to serve all parties involved.”

In concluding her testimony, Greer said: “We don’t want to re-invent the wheel.  We want to fix the one we have.”

Where House Leadership Stands…

House Minority Leader Michael L. Chippendale (R-District 40, Coventry, Foster, Glocester), goes on the record supporting Carson’s call to create a special legislative commission to study aging policy in the state. “House Republicans recognize the fact that RI is aging and how important it is to coordinate our services to cut duplicity and inefficiencies. A study commission establishes a deep dive public discussion into an understanding of our statewide need, and lessens the possibility of bureaucratic, unintended consequences, which can occur in the submission of haphazard bills,” he says, noting that “Republicans also believe that this is an area, where if the topics are properly vetted, the state can cut costs and bring efficiency to our core government senior services.”

“I support the concept of this commission and I am certainly open to it, but I need to discuss it further with the sponsor, Representative Lauren Carson, before recommending further action. I look forward to speaking with her in the coming weeks of the legislative session,” says House Speaker K. Joseph Shekarchi (D-District 23, Warwick).

Shekarchi and his leadership team will evaluate all legislative resolutions creating House Study Commissions introduced this legislative session to determine which one(s) will be allowed to proceed for a committee, and ultimately, floor vote.  At press time, there is no fiscal note. Creating House Study Commissions must have adequate resources and staffing for their operations. 

With H 5224 having bipartisan support, aging organizations hope that Speaker Shekarchi sees the importance of allowing a committee and floor vote on this resolution.  Democratic and Republican lawmakers must lobby the House Speaker for his endorsement to support passage of this very important commission. Every Rhode Islander will ultimately need to access comprehensive aging programs and services in their later years.

House debate on Carson’s Health Study Commission may well create the political will down the road after it releases its report leading to the creation of Rhode Island’s first Strategic Plan on Aging.

H 5224 cosponsors are Representatives Samuel A. Azzinaro (D-District 37, Westerly), Thomas E. Noret (D-District 25, West Warwick), Susan R. Donovan (D-District 69, Bristol, Portsmouth), House Majority Whip Katherine S. Kazarian (D-District, East Providence), Karen Alzate (D-District 60, Central Falls, Pawtucket), Jason Knight (D-District 67, Barrington, Warren),  and Kathleen Fogarty (D-District 35, South Kingston.

To show your support for H 5224, contact your House Representative.  Go to https://www.rilegislature.gov/representatives/default.aspx. You can also contact House Speaker Shekarchi by calling (401) 222-2447.  Or email, rep-shekarchi@rilegislature.gov.

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