Tag: nursing homes

Feds Announce More Aggressive Enforcement of Poor Performing Nursing Homes

In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program.[ii]

The SFF Program was created to help and oversee the poorest performing nursing homes in the country and improve nursing homes that have a history of noncompliance.  The goal is to improve safety and quality of care. The facilities selected for the SFF Program must be inspected no less than once every six months and if severe enforcement is needed, it is at the discretion of the state surveyors. The main objective for the SFF Program is for facilities to show exponential improvement, graduate from the program, and then maintain compliance and better quality of care and safety.

The new CMS requirements, outlined below, are aimed at facilities that continuously fail to improve and remain in the SFF Program for a prolonged period of time. Health and Human Services Secretary Xavier Becerra stated, “Let us be clear: we are cracking down on enforcement of our nation’s poorest-performing nursing homes. As President Biden directed, we are increasing scrutiny and taking aggressive action to ensure everyone living in nursing homes gets the high-quality care they deserve. We are demanding better because our seniors deserve better.”

CMS announced the following revisions to the SFF Program:

  • Effective immediately, CMS will use escalating penalties for violations for deficiencies cited at the same level in subsequent surveys. This can include possible discretionary termination from Medicare and/or Medicaid funding for facilities that are cited with immediate jeopardy deficiencies on any two surveys while participating the in the SFF Program.
  • CMS will consider facilities’ efforts to improve when considering discretionary termination from Medicare and/or Medicaid programs.
  • CMS will impose more severe escalating enforcement remedies for SFF Program facilities for noncompliance and no effort to improve performance.
  • Increased requirements that nursing homes in the SFF Program must meet to graduate from the SFF Program.
  • For three years after graduation from the SFF Program, CMS will ensure nursing homes consistently maintain compliance with safety requirements by continuing to closely monitor these facilities.
  • CMS is offering more support resources to facilities selected for the SFF Program.

Additionally, the Biden administration released a fact sheet with the steps they are taking to in improve the quality of nursing homes. [iii] Some of the steps mentioned include more resources to support union jobs in nursing home care, establishing minimum staffing requirements, incentivizing quality performance through Medicare and Medicaid funding, and enhanced efforts to prevent fraud and abuse.

  1. https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/…
  2. https://www.cms.gov/files/document/qso-23-01-nh.pdf
  3. https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/21/…

Article By Thomas W. Hess, Kelly A. Leahy, Sydney N. Pahren, and Bryan L. Cockroft of Dinsmore & Shohl LLP

For more health law and managed care legal news, click here to visit the National Law Review.

© 2022 Dinsmore & Shohl LLP. All rights reserved.

Do I Have to Sign Over All My Assets when I Enter a Long-Term Care Facility?

I get asked some version of this question fairly frequently. I generally reassure clients that most facilities simply require you to pay month-to-month, and you can leave at any time. Now I may have to change my response, as news broke this week that a New Jersey woman allegedly had all her assets stolen by the very entity she trusted to care for her.

The woman entered a facility for a short-term rehab stay with every intention of returning home. Apparently the facility thought otherwise, as they enlisted a financial company to “assist” the woman in liquidating her assets to pay for her facility care and spend down to apply for Medicaid. I and other elder lawyers, along with several consumer protection agencies in the state, have long warned consumers about nonlawyer Medicaid advisors. These entities work closely with the nursing home industry, often having the same ownership and leadership. In this case, the POA is both an officer with the facility and the principal of the Medicaid advisor company that was hired to make the resident Medicaid eligible without her knowledge.

Some facilities require or coerce residents to hire these Medicaid advisors to prepare Medicaid applications for them. Unfortunately, they are not lawyers, and their allegiance is clearly to the facilities and not the residents or their families. Therefore, they fail to advise residents of opportunities to protect assets or income. Even worse, in many cases they failed to complete or submit the application or did so in a negligent manner, resulting in the application being denied. But unlike when an attorney messes up, there is no recourse for families, as these entities do not carry malpractice insurance. Sometimes the Medicaid advisor will simply close up shop and disappear – only to resurface later with a different organization.

There have been prior reports of facilities and the Medicaid advisors they work with requiring residents to sign POAs and even accessing resident accounts through questionable means. These latest allegations, however, bring this situation to a new level. It is alleged that the resident was forced to sign a POA when she did not have the capacity to do so due to medications she was prescribed. It was further alleged that Future Care Consultants liquidated the resident’s assets without her knowledge, and the funds were not returned when she left the facility. The family also alleges they were prevented from visiting or communicating with the resident.

The allegations are reminiscent of the movie I Care a Lot, which I have previously criticized as being completely unrealistic. However, in recent months, I have had clients report they were threatened by facilities if they used the services of an attorney. It is essential that consumers know their rights. You cannot be required to sign a POA. You cannot be forced to hire anyone to file your Medicaid application. And you cannot be prevented from using an attorney if you wish to do so.

Article By Shana Siegel of Norris McLaughlin P.A.

For more family law legal news, click here to visit the National Law Review.

©2022 Norris McLaughlin P.A., All Rights Reserved

CMS Removes All Nursing Home Visitation Restrictions as COVID-19 Cases Decrease

In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here.

Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times. CMS explained its decision to allow visitation is based upon data which shows approximately 86% of residents and 74% of staff are fully vaccinated, and the number of new COVID-19 cases each week in nursing homes has dramatically decreased.

Under the new guidance, nursing homes cannot limit the frequency and length of visits for residents, the number of visitors, or require advance scheduling of visits as mandated under the previous guidance. However, CMS is still directing nursing homes to follow infection-control policies and procedures. Visitors who have tested positive for COVID-19, have symptoms of COVID-19, or currently meet the criteria for quarantine, should not enter the facility. Nursing homes should still screen all visitors before entry.

Although not required, CMS is encouraging nursing homes in counties with substantial or high levels of community transmission to offer testing to visitors, if feasible. Nursing homes should also educate and encourage visitors to become vaccinated. Visitors should still wear face coverings and social distance at all times while in the nursing home. Nursing homes should stay diligent in their infection-control efforts.

Article By Sydney N. Pahren and Timothy Cahill of Dinsmore & Shohl LLP

© 2021 Dinsmore & Shohl LLP. All rights reserved.

EPA Registers New Uses for Existing Products to Help Reduce the Spread of Candida auris

On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris).  C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents.  The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections.  There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.

EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris.  Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.

The 11 products that are now registered for use against C. auris are:

  •  Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
  •  Blondie (EPA Reg. No. 67619-24);
  •  Dagwood (EPA Reg. No. 67619-25);
  •  Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
  •  Oxivir 1 (EPA Reg. No. 70627-74);
  •  Oxivir 1 Wipes (EPA Reg. No. 70627-77);
  •  Oxivir Wipes (EPA Reg. No. 70627-60);
  •  Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
  •  Virasept (EPA Reg. No. 1677-226);
  • Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
  •  Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).

Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris.  The label on the product will not include instructions for C. auris.  CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:

  •  Oxivir TB Spray (EPA Reg. No. 70627-56); and
  •  PDI Super Sani-Cloth (EPA Reg. No. 9480-4).

The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).

Additional information on C. auris is available on EPA’s website and CDC’s website.

©2020 Bergeson & Campbell, P.C.

For more on EPA disinfectant registrations, see the National Law Review Environmental, Energy & Resources section.

Incapacitated Woman Gave Birth in Arizona Nursing Home: Attorneys Seeking $45M from the State

Late last December, a nurse at Hacienda HealthCare in Arizona panicked and called 911 as a patient unexpectedly gave birth. The 29-year-old patient, who has been in a vegetative state since age 3, delivered a healthy baby boy. A police investigation concluded that one of her caregivers, a 32-year-old male nurse, raped the patient several times and fathered the child. The victim’s attorneys filed a $45 million notice of claim against the state of Arizona in late May.

After giving birth in the nursing home, the victim and baby were transferred to a nearby hospital. According to the hospital, the baby’s birth was “a repeat parous event,” meaning the victim had likely been pregnant before.

As a result of a near drowning experience in 1992, the victim is described as non-verbal and generally unresponsive. However, she does experience pain and can respond to her surroundings with a groan or a smile.

The staff full of medical professionals said they did not realize the woman was pregnant until a nurse went to change the victim and saw the baby’s head.

An anonymous former caregiver for the woman told ABC-15 she didn’t believe the pregnancy went undetected. “I can’t believe that somebody would bathe her daily for nine months and never know that she wasn’t having a period, that she [was] growing in her midsection, that nurses weren’t keeping track [of her weight],” the former caregiver said. “Those things are shocking to me.”

According to the notice of claim, the nursing home missed 83 opportunities to diagnose the pregnancy. The staff noted the patient’s abdomen was sticking out during 24 checks, and noted swollen legs and feet 12 times. A doctor saw the patient at least 10 times during her third trimester.

Hacienda HealthCare was entrusted to give the patient around-the-clock care. Not only did they overlook the signs of repeated sexual abuse the hospital reported, which allowed for it to continue, but they also failed to detect her pregnancy. The facility’s negligence caused the patient to go through her pregnancy without any proper care and in a state of malnutrition.

The complaint argues that the state of Arizona “cultivated circumstances” that enabled this misconduct and failed to monitor the long-term care facility.

There are many forms of abuse in nursing homes, to both younger and elderly patients. The long-term care facilities we trust with our loved ones are responsible for their safety and well-being.

 

COPYRIGHT © 2019, STARK & STARK
Article by Sherri Warfel of Stark & Stark.
For more on health care issues see the National Law Review Health Law & Managed Care page.

Compliance With Florida’s “Generator” Laws

Earlier this year, Florida Governor Rick Scott signed into law HB7099and SPB7028 (collectively referred to as the “Bills”), ratifying emergency rules that require nursing homes and assisted living facilities to acquire alternative power sources– such as generators- and fuel in preparation of the upcoming hurricane season. See Rule 59A-4.1265 and Rule 58A-5.036. These rules were enacted after 14 residents died from heat-related illnesses and complications during Hurricane Irma last year when a Florida nursing home lost power to its air conditioning units for three days.

The Bills went into effect on March 28, 2018, and required qualifying facilities to come into compliance by June 1, 2018, unless granted an extension by the Governor whereby compliance is expected by January 2019. Facilities that can show delays caused by necessary construction, delivery of ordered equipment, zoning, or other regulatory approval processes are eligible for an extension if the facility can provide residents an area that meets the ambient temperature requirements for 96 hours. Extensions are granted on a case-by-case basis, although so far a majority of Florida facilities have been granted an extension. Indeed, it appears that over 77% of nursing homes received an extension in the first week of June. Additionally, facilities located in an evacuation zone pursuant to Chapter 252, F.S., must either evacuate its residents prior to the arrival of any emergency event, or have an alternative power source and no less than 96 hours of fuel stored onsite at least within 24 hours of the issuance of a state of emergency. Failure to comply with any provision may result in the revocation or suspension of a facility’s license and/or the imposition of administrative fines.

Nursing Homes and Assisted Living Facilities Must Develop Emergency Plans that Provide for Alternative Power Sources and Fuel Capable of Maintaining an Ambient Temperature of No Greater Than 81 Degrees Fahrenheit for At Least 96 Hours.

Nursing Homes and Assisted Living Facilities must prepare a detailed plan (“Plan”) that provides for the acquisition and maintenance of alternative power sources- such as generators- and fuel. The Plan will supplement a facility’s Comprehensive Emergency Management Plan and must be submitted to and approved by the requisite agency. While the Bills do not require facilities to maintain a specific type of power system or equipment; the alternative power sources utilized by a facility must be capable of maintaining an ambient temperature of no greater than 81 degrees Fahrenheit for at least 96 hours after the loss of primary electrical power. This temperature must be maintained in areas of sufficient size to shelter residents safely. Alternative power sources and fuel should be maintained in accordance with local zoning restrictions and the Florida Building Code.

Moreover, the Bills set forth additional requirements for nursing homes and assisted living facilities in evacuation zones, as well as for single campus and multistory facilities.

  • Facilities in Evacuation Zones – A facility in an evacuation zone pursuant to Chapter 252, F.S. must provide in their Plan for the maintenance of an alternative power source and fuel at all times when the facility is occupied but may utilize mobile generators to facilitate evacuation.
  • Single Campus – Single campus facilities under common ownership may share alternative power sources and fuel space if such resources are sufficient to maintain the ambient temperature required under the rules.
  •  Multistory Facilities – Multistory facilities, whose Comprehensive Emergency Management Plan comprises of moving residents to a higher floor during flood or surge events, must place their alternative power source and all additional equipment in a location protected from flooding or storm surge damage.

Fuel Storage Requirements Vary by Facility Size and Location.

The Bills require facilities to provide for storage of a certain amount of fuel based on their size and location. Assisted living facilities with 16 beds or less must store a minimum of 48 hours of fuel, while assisted living facilities with 17 beds or more a required to store a minimum of 72 hours of fuel. All nursing homes must store a minimum of 72 hours of fuel. Nursing homes and assisted living facilities located in a declared state of emergency area pursuant to Section 252.36, F.S., that may impact primary power delivery, must secure 96 hours of fuel; these facilities may utilize portable fuel storage containers for the remaining fuel necessary for 96 hours during the period of a declared state of emergency.

Emily Budicin, a 2018 Summer Associate in the firm’s Washington, DC office, contributed significantly to the preparation of this post.

 

©2018 Epstein Becker & Green, P.C. All rights reserved.

What You Should Know About Special Focus Facility Nursing Homes

The Center for Medicare Advocacy (CMA) recently issued a Special Report focusing on progressively ineffective enforcement actions against nursing-home facilities that have demonstrated a pattern of serious noncompliance with federal nursing-home care standards meant to ensure quality care and resident safety.

The report concludes that in addition to a noncompliant nursing home’s ability to mislead consumers about its quality of care by masking staffing levels and self-reporting quality-care measures to the federal government, penalties in the form of monetary fines—imposed on the most unsafe nursing homes—are declining, and thus, are likely ineffective in improving the care provided to residents.

In cooperation with state surveyors, the Centers for Medicare & Medicaid (CMS) regularly visits nursing homes to determine whether they are ensuring resident safety by complying with federal nursing-home care standards: The standards also determine whether nursing homes may participate in Medicare and Medicaid reimbursement programs. And while most nursing homes have some deficiencies, most of them correct those problems within a reasonable period of time. But for nursing homes with (1) a history of having twice the average number of deficiencies, (2) deficiencies resulting in serious quality and safety issues, and (3) those issues persisting over a long period of time, CMS identifies them as Special Focus Facilities (SFF) and subjects them to additional surveys and fines.

CMS attempts to notify the public about identified SFF’s by publishing a monthly report providing the status of SFF’s by grouping them into categories separated by the following Tables:

Table Category
A Newly Added
B Not Improved
C Improving
D Recently Graduated
E No Longer in Medicare and Medicaid

The report also contains the number months the nursing home has operated as SFF.

As of the most recent SFF Update, July 19, 2018, CMS identified or had identified the following New Jersey Nursing Homes as Special Focus Facilities:

Nursing Home Location Status Months as SFF
New Grove Manor East Orange Newly Added 4 months
Cooper River West Pennsauken Improving 12 months
Meadowview Nursing & Respiratory Care Williamstown Recently Graduated 15 months

CMS also attempts to notify the public about the quality of care provided by all Medicare- and Medicaid-certified nursing homes in the country through its Nursing Home Compare Five-Star Rating website. The star-rating system gives each nursing home a rating from 1 to 5 stars in three categories: (1) health inspections, (2) staffing, and (3) quality of resident care measures (collected on each patient). Based on those ratings, CMS also calculates an overall rating.

However, while all three categories help provide a snapshot of a nursing home’s quality, a New York Times article faulted the five-star rating system for being susceptible to manipulation, and thus capable of misleading the public. That is because CMS allowed nursing homes to self-report data for two of the three categories: staffing and quality of resident care measures.  Only the health inspections category provided an independent window into the quality of a nursing home, because CMS conducts the inspections onsite and reports the results of the inspections.

Healthcare professionals have traditionally viewed the level of staffing as indicative of the nursing home’s ability to provide quality care and ensure patient safety. But even after the 2015 revision to the 5-Star Rating System to, in part, improve the accuracy of reporting staffing levels, nursing homes have continued mask the erratic levels of individuals working from day to day.

So while an unsafe nursing home may report a high-quality star rating (4 or 5 stars) in staffing and quality care measures, the health inspections category provides a more accurate assessment of how well the nursing home protects residents from harm.

For example, as of July 30, 2018, the Nursing Home Compare website reports the following quality star ratings for New Grove Manor nursing home, listed above:

The CMS website shows that despite CMS (1) assigning a Much Below Averagerating (1 star) for health inspections, (2) assigning a Below Average rating (2 stars) for overall quality, and (3) identifying New Grove Manor as a Special Focus Facility—CMS permits New Grove Manor to report an Above Average rating (4 stars) for staffing levels and to self-report an Above Average rating (4 stars) for quality measures..

Moreover, the CMA Special Report suggests that despite the poor performance of the 18 Newly Added nursing homes in the SFF Update, July 19, 2018, enforcement actions against those nursing homes are relatively minor. The Special Report notes that when attributing the total amount fines ($992,325) to all 18 Newly Added facilities, covering the prior 3-years, the average fine per year for each SFF is $18,375. However, as the Special Report notes, CMS imposed fines on only 12 of the 18 nursing homes over the prior three years. Thus, for those 12 nursing homes, the average fine per year was merely $27,562.

 

COPYRIGHT © 2018, STARK & STARK
This post was written by Eric D. Dakhari of Stark & Stark Law Firm.

When Nursing Homes Feed Into Corporate Web, Patient Care Fails

According Kaiser Health News, an analysis of nursing home financial records revealed that nearly three-quarters of all nursing homes in the U.S. are owned by people who also have vested interest in companies that in turn sell services and goods to these same nursing homes.

These business dealings are known as “related party transactions.” These transactions enable a nursing home owner to arrange contracts with their related businesses above a more competitive price, allowing them to turn around and siphon off the extra profit.

As an additional benefit, creating these corporate “webs” provides a layer of legal protection to nursing home owners. When a nursing home is sued, it is often very difficult for victims and their families to collect from the other related companies an owner holds stake in, thereby allowing them to “shore” away money.

Unfortunately, nursing homes which deal in “related party transactions” tend to have significant shortcomings which specifically affect their patients. The Kaiser Health News analysis showed that nursing homes which outsource to related organizations “have fewer nurses and aides per patient, have higher rates of patient injuries and unsafe practices, and are the subject of complaints almost twice as often as independent [nursing] homes.”

In order for related companies to be brought into a nursing home lawsuit, the client’s attorney needs to convince the judge that all the companies acted together as “one entity,” meaning that the nursing home was unable to make standalone decisions. This is a complicated and often time and money intensive decision, as it often requires obtaining evidence like company documents and emails to prove the connections.

 

COPYRIGHT © 2018, Stark & Stark.
This post was written by Sherri Warfel of Stark & Stark.
More health news is available on the National Law Review’s Health Page.

CNN Investigates Expanding Use of Nuedexta in Nursing Homes

A recent investigation by CNN brought to light the expanding and allegedly inappropriate use of the prescription drug Nuedexta in nursing homes throughout the country. Nuedexta is FDA-approved to treat a rare condition known as pseudobulbar affect (PBA).

What is Pseudobulbar Affect?

Pseudobulbar affect is characterized by sudden and uncontrollable laughing or crying. It is associated with people who have multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALM), known as Lou Gehrig’s disease. Avanir Pharmaceuticals has been aggressively targeting elderly nursing home residents with the drug, the CNN investigation found, although PBA reportedly impacts less than 1 percent of Americans, based on a calculation using the drug maker’s own figures.

What the Investigation Revealed

Nuedexta prescription use in nursing homes is rising at a rapid rate, even though Avanir Pharmaceuticals acknowledges that the drug has not been extensively studied in elderly patients, according to CNN.

CNN found that Avanir Pharmaceutical’s sales force is focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, coupled with “high-volume prescribing and advocacy efforts by doctors receiving payments from the company.”

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

In response to requests to be interviewed for the CNN article, Avanir reportedly responded by email with a statement that PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders that are common in nursing home residents.

Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with neurological conditions such as dementia. But geriatric physicians, dementia researchers, and other medical experts reportedly told CNN that PBA is extremely rare in dementia patients.

How Can Nuedexta Impact Nursing Home Residents?

One study of 194 patients with Alzheimer’s disease found that patients taking Nuedexta suffered more than twice as many falls as those patients taking a placebo.

CNN reports that Lon Schneider, director of the University of Southern California’s California Alzheimer’s Disease Center, reviewed information from several hundred reports obtained by CNN through the Freedom of Information Act. Schneider expressed concern about potential interactions between Nuedexta and other medications intended to treat problematic behaviors. These medications may include antipsychotic drugs, antidepressants, and anti-anxiety medication which are often given to nursing home residents to suppress anxiety or aggression that may occur with Alzheimer’s disease and other dementia types.

Why Are Doctors Prescribing Nuedexta to Nursing Home Residents?

According to CNN’s analysis of government data, between 2013 and 2016, Avanir and its parent company, Otsuka, paid almost $14 million to physicians for Nuedexta-related consulting, promotional speaking, and other services. The companies also spent $4.6 million on travel and dining costs. CNN found that in 2015 nearly half the Nuedexta claims filed with Medicare came from doctors who had received money or other perks.

According to the investigation, state regulators have found that doctors may inappropriately diagnose nursing home residents with PBA to justify the use of Nuedexta to treat confusion, agitation, and unruly behavior. Further, doctors may inappropriately diagnose nursing home residents with PBA to justify the use of Nuedexta to treat confusion, agitation, and unruly behavior. A diagnosis of PBA may be used because “off-label” prescriptions written by doctors using Nuedexta to treat patients who have not been diagnosed with PBA would typically not be covered by Medicare.

What Adverse Events Have Been Reported With Nuedexta Use By Nursing Home Patients?

Soon after Nuedexta came on the market, doctors, nurses, and nursing home patients’ family members began filing reports including rashes, dizziness, and falls as well as comas and death. CNN found that Nuedexta was listed as a “suspect” medication in nearly 1,000 adverse event reports received by the FDA. These reports disclosed side effects, drug interactions, and other issues. According to CNN, the FDA declined to comment on adverse events or the approval process for Nuedexta.

This post was written by Denise Mariani  of STARK & STARK, COPYRIGHT © 2017
For more legal analysis, go to The National Law Review

Nursing Home Residents Deprived of Right to Sue for Abuse and Neglect

The current administration has set its sights on another federal rule, seeking to eliminate the ban on pre-dispute arbitration agreements for nursing home residents. Pre-dispute arbitration agreements require elderly adults and individuals with disabilities, as well as their families, to waive their right to file a lawsuit in the courts – before admission to a nursing home. As a condition to entering the nursing home, the prospective resident and his or her representative would be required to submit any dispute, including claims of egregious abuse or neglect, to mandatory arbitration proceedings.

The Current Rule

As the rule currently stands, a nursing home resident cannot be required to waive his or her right to access to the court system. This rule preserves the right of vulnerable nursing home residents to sue for injuries caused by nursing home negligence, abuse, and neglect, including pressure sore infections, suffocation caused by restraints, choking, dehydration-related conditions, gangrene, and even sexual assault.

Decision-making at the Nursing Home Door

Nursing home admission is a stressful and emotional time for the prospective resident and his or her family. Requiring a waiver of rights as a condition of admission, as occurs with pre-admission arbitration agreements, puts the person and his or her family in a time-sensitive quandary, literally at the nursing home door. Under the new amendments, if they refuse to sign away their right to go to court, they can be denied admission to the facility.

Imagine after months of discussions, the decision is finally reached to admit an elderly or disabled individual to a nursing home. This decision often involves the heartache of giving up one’s home and freedom, many possessions, and even treasured pets. The decision is often motivated by a desire to keep the individual safe and ensure that he or she receives required medical care.

But, are nursing home residents safe when they are required to sign away any right to legal accountability for mistreatment or harm in the facility?

How Arbitration is Different than a Lawsuit

Arbitrations take place in private meetings and are confidential. Because arbitrations are not public proceedings like lawsuits and trials, nursing homes have little to fear in terms of lost business or reputation, even if the arbitrator rules against them. To make matters worse, usually the pre-admission arbitration agreements give all the decision-making about the process to the nursing home, including selecting the arbitrator, location, and rules that will govern the proceedings. That removes other safeguards provided by the original rule such as choosing a neutral arbitrator.

Background on the Rule and Proposed Amendment

On October 4, 2016, the Centers for Medicare & Medicaid Service (CMS) published a final rule entitled “Reform of Requirements for Long-Term Care Facilities.” The 2016 final rule amended 42 CFR 483.70(n), prohibiting long-term care (LTC) facilities from entering into pre-dispute arbitration agreements with residents or their representatives. The final rule also prohibited any requirement that a resident sign an arbitration agreement as a condition of admission to a LTC facility.

That final rule sought to preserve the right of vulnerable nursing home residents to sue in court if they suffered injury or abuse.

The American Health Care Association and a group of nursing homes sued for preliminary and permanent injunction to stop CMS from enforcing that requirement. The court granted a preliminary injunction on November 7, 2016. Thereafter, CMS reviewed and reconsidered the arbitration requirements in the 2016 final rule.

In proposed amendments to the rule under the current administration, CMS now seeks to strip nursing home residents of that right by removing the provisions prohibiting binding pre-dispute arbitration in LTC facilities. CMS provides as a reason for this action that a ban on pre-dispute arbitration agreements would “likely impose unnecessary or excessive costs on providers.”

CMS’s Proposed Revisions to Arbitration Requirements

This proposed rule focuses on the transparency surrounding the arbitration process and includes proposes that:

  • The prohibition on pre-dispute binding arbitration agreements is removed.

  • All agreements for binding arbitration must be in plain language.

  • If signing the agreement for binding arbitration is a condition of admission into the facility, the language of the agreement must be in plain writing and in the admissions contract.

  • The agreement must be explained to the resident and his or her representative in a form and manner they understand, including that it must be in a language they understand.

  • The resident must acknowledge that he or she understands the agreement.

  • The agreement must not contain any language that prohibits or discourages the resident or anyone else from communicating with federal, state, or local officials, including federal and state surveyors, other federal or state health department employees, or representatives of the State Long-Term Care Ombudsman.

  • If a facility resolves a dispute with a resident through arbitration, it must retain a copy of the signed agreement for binding arbitration and the arbitrator’s final decision so it can be inspected by CMS or its designee.

  • The facility must post a notice regarding its use of binding arbitration in an area that is visible to both residents and visitors.

This post was written by Denise Mariani of  Stark & Stark.