We wanted to share American Association for Justice’s comments to Center for Medicare Services (CMS), on the potential review of 42 CFR 483 Subpart B.   If the Agency is going to change  regulations affecting the quality of health care in nursing homes, they should be focusing on patient safety and increased accountability through such things as eliminating arbitration clauses and eliminating over medication problems better know as chemical restraints.

 

An interesting article in The Atlantic explained that traditionally nursing homes have operated in a fashion similar to asylums, with their primary purpose to serve as residential medical institutions. Even though this is still too common in most nursing homes, there is a gradual “culture change” towards a more personal resident-centered care and a more home-like facility.  In these new facilities pets and children are welcome to visit and residents are encouraged to take part in voluntary, every-day tasks such as maintaining a plant, selecting and “ordering” their meals like in a restaurant, and preparing their own snacks. Also, the resident and their family members are more involved in creating their own personalized care plan. All of these improvements aim to give the residents a greater sense of empowerment and an improved quality of life.

This shift focuses on building strong relationships between the residents and care givers and making the facility’s environment as welcoming and personal as possible.  Most national for profits chains have not adopted this cultural change especially in Southern states.  According to The Alliance for Quality Nursing home care, more than half of the nation’s nursing homes are participating in this change of culture where facilities consider individual residents’ needs instead just operating in an uniform, institutionalized style.  See article in Senior Housing Newshere.

However there are encouraging developments for this positive shift in nursing home “culture.”  The new Medicare/Medicaid Quality Indicator Survey is very resident-focused rather than focused on the facility as a whole.  For example, the Survey concentrates more on if the individual residents are being served food that meets their personal nutritional needs and taste than general facility details such as what time meals are being served.

It is important to for nursing homes to continue to look past their outdated traditions and seek more innovative ways to care for residents and improve their quality of life.
 

The Chicago Tribune reported the suspicious death of a resident after a fatal altercation with another resident at Oak Park Healthcare Center.  The nursing home failed to report the altercation to the health department for further investigation. Anibal Calderon, 80, died of head injuries after an alleged fight that took place.  Calderon’s death was ruled a homicide by the Cook County medical examiner’s office. The Illinois Department of Public Health is now investigating.

Under state law, the nursing home should have reported the incident immediately to the health department as well as to the family of the victim and local police. Federal regulations require that nursing home residents involved in violent incidents be removed from the facility if necessary for their safety and the safety of others.  State officials have no record that Oak Park Healthcare notified the health department, said spokeswoman Melaney Arnold.  The for-profit nursing home has 204 beds and an occupancy rate of about 75 percent, according to the state. 

Nursing homes are also required to make available for public inspection the five most recent years of survey materials that would list possible violations, according to the IDPH website. But the Tribune reporter was escorted out of the Oak Park facility after requesting to look at the documents.

 

The New York Times reported that the Obama Administration will require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.   Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.   Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Critics and researchers have found evidence that such payments influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices. Consumer advocates agree that disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for "providing advice and giving lectures".   The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

 

Press of Atlantic City wrote an article discussing the dismal record of New Jersey nursing homes. Seven New Jersey nursing homes received the lowest quality ratings from the federal government last year based partly on state inspections in 2009 and 2010. Inspection reports show that residents in the worst-rated homes live in dirty conditions, endure verbal and physical abuse, and are neglected.

Hundreds of violations of rules that govern quality of care, safety and sanitation were found by inspectors during the past two years at the 60 nursing homes in Atlantic, Cape May, Cumberland and Ocean counties. The reports are used by the U.S. Department of Health and Human Services to develop consumer ratings of one to five stars for nursing homes. The majority of area facilities – 65 percent – are rated three stars or lower, federal data show, and half are in the bottom two levels.

A review of more than 1,800 pages of New Jersey Department of Health and Senior Services inspection reports from 2009 through April 2011 for 10 nursing homes showed that residents are routinely found living in dirty conditions, endure verbal and physical abuse, and are subject to neglect. Other violations include staff giving out the wrong medications, residents being strapped into wheelchairs and ignored for hours, theft, untreated infections, falls resulting from fragile residents being left unattended, and fire- and building-code violations.

State reports provide details of problems found during inspections. Some residents live in fear of reprisal if they complain about conditions.

A recurring theme was a failure to investigate or report incidents of abuse. Another recurring problem was failure to properly administer medication.  The medication error rate is not supposed to exceed 5 percent. A November inspection found an 18 percent error rate at South Jersey Extended Care. Our Lady’s Residence had a 14 percent error rate. Lincoln Specialty Care was at 9 percent, and Arcadia was at 8 percent. In one case at South Jersey Extended Care, a resident was supposed to get morphine every three hours for rectal pain, but went days without it because there was none.

A nurse and an aide allegedly told a resident who wanted help getting out of bed frequently overnight that she could not get up before 4 a.m. The inspection report states the staffers threatened to take away her wheelchair, withheld snacks and threatened to keep her in bed longer if she complained. The report states the resident shook in fear in the presence of the nurse and aide.

There are 367 nursing homes in New Jersey charging an average of $250 per patient per day, said Paul Langevin of the Health Care Association of New Jersey, a trade group of 185 homes.  Most homes are for-profit businesses run by companies that have multiple facilities. Costs of more than $90,000 per patient per year are often paid through Medicare and Medicaid, so tax dollars pay much of the bill.

Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. 
 

The News & Observer had an article about the civil lawsuits that have been filed against Britthaven after a Britthaven nurse heads to court on murder charges in the morphine-related death of a patient, and serious injuries to two other patients.  Registered nurse Angela Almore ihas been charged with second-degree murder and patient-abuse charges related to the death of 84-year-old Rachel Holliday and morphine-induced injuries to six other patients.   A medical examiner reported that Holliday died of pneumonia and that the levels of morphine in her system likely contributed to her death. None of the patients had been prescribed morphine.

The case of Jadwiga Orlowski v. Britthaven Inc. is one of the cases pending.  The suit accuses Britthaven of negligence, including failure to monitor Orlowski, who suffered from dementia according to the complaint, and not providing a bed with side rails.

Her husband, Marian Orlowski, died of pneumonia on July 16 at age 86.  Orlowski was a former distinguished professor in pharmacology at The Mount Sinai School of Medicine in New York, was nominated for a Nobel prize in 2004 for his pioneering drug treatment for blood-plasma cancer.

"Later on that same day, Dr. Marian Orlowski was found on the floor of his room," states a legal complaint filed by the Orlowskis’ attorney, Carmaletta Henson. "He had fallen and sustained serious personal injuries, including a fracture to his left hip."

Britthaven of Chapel Hill is one of four "special focus facilities" in the state. This designation by the federal Centers for Medicare and Medicaid Services notes a pattern of substandard care. Chapel Hill Health and Rehabilitation, along with the Brian Centers in Goldsboro and Gastonia (owned by SavaSeniorCare), are also on the list.

Last year, CMS ordered Britthaven of Chapel Hill to pay $216,400 in fines because it was out of compliance with Medicare requirements. Those penalties stem from the case of Mary Lou Barthazon, a 95-year-old woman who likely broke both thigh bones near her knees on Sept. 30, 2007, when a nursing assistant dropped her while trying to lift her from a chair to her bed, according to a federal judge.  The nursing assistant ignored Barthazon’s care plan, which required a mechanical lift.  Her fractures went untreated for two weeks because the nursing assistant did not report the incident. Barthazon’s daughter, Anne Blanchard, insisted Barthazon go to the emergency room on Oct. 14. She died four days later.

Blanchard has sued Britthaven, alleging negligence and wrongful death. In her motion to dismiss the lawsuit, Britthaven lawyer Pamela Robertson denies "that defendants had a duty to supervise or control the clinical care, treatment or judgment of any healthcare provider."

Robertson’s motion also denies "that either state or federal nursing home standards, policies, regulations, rules or standards of participation establish the standards of health care applicable to Britthaven of Chapel Hill."

Britthaven tried to avoid a trial by forcing the case to arbitration. Superior Court Judge Abraham Penn Jones concluded that the contract was signed under duress as both she and her mother were suffering serious health problems and her 23-year-old daughter had only months earlier suffered partial paralysis in a rollerblading accident. Wrote Jones, "The contract is … procedurally and substantively unconscionable."

 

Here is a great editorial from the Louisville Courier Journal about the need for nursing home reform and lobbyists’ influence.

The real priorities of the General Assembly are on shocking display in the battle over a nursing home reform bill. The measure, House Bill 157, which is intended to set minimum standards for staffing, is similar to laws that exist in 37 states.

 

But the reform bill’s co-sponsor told The Courier-Journal’s Laura Ungar that its chances seem dim this session.

Meanwhile, over the past decade the nursing homes’ trade group has showered a quarter of a million dollars on Frankfort lawmakers, some of whom are persuaded — surprise — that the reform is unnecessary.

The claim of trade group president Ruby Jo Cummins Lubarsky would be laughable, if it were not so sad. The nursing home bill, she says, is not needed because, “Numbers don’t equate to quality. Staffing is very important in a facility, and there is no incentive for a facility to not meet the needs of its residents.”

Ask anyone who has had a friend or relative in a nursing home whether the issue of staffing isn’t a major one. Even in the best-run homes, it’s not uncommon for aides to be surly, dilatory or lack basic communication skills. And residents, many of whom suffer deep depression, dementia and other conditions, are often incapable of being heard when they complain. The powerful stench of feces and urine often greet the visitor at the door. Residents may lie or sit for hours in wet diapers or on fouled sheets — simply because there is not enough help, or because it’s not responsive enough.

Many nursing homes benefit handsomely from Medicare and Medicaid tax dollars. Many are for-profit operations that cut back on staff to pump up the bottom line. Federal regulations are considered inadequate by knowledgeable observers and by all but 13 states.

The elderly in Kentucky deserve better than that. And the legislators holding the bill back should have them on their consciences.
 

Many times, a family member of a nursing home resident will call us with concerns about bruises, unexplained injuries, falls, and pressure ulcers.  We suggest that they look at the medical records.  Numerous nursing homes will refuse to allow family members access to the medical records despite 42 CFR 483.10(j)(1)(vii) – which clearly states:

(1) The resident has the right and the facility must provide immediate access to any resident by the following:

(vii) Subject to the resident’s right to deny or withdraw consent at any time, immediate family or other relatives of the resident.

Nursing homes are either ignorant of their responsibilities or intentionally concealing material and medical information to residents and their family members.  Why would a nursing home refuse to allow a family member of the resident access to the chart?  Many times, after a family requests the chart, nursing homes send the chart to outside legal and clinical consultants to "clean up" the information in the chart.  The above federal regulation needs to be enforced.  The best way is to complain to your local ombudsman, state health agency, and your local politician.