Resources from the Law Office of John L. Roberts

An inspector for the U.S. Department of Health and Human Services says that Medicare should begin penalizing nursing homes that inappropriately prescribe antipsychotics. His testimony, provided to the Associated Press, was delivered to the Senate Committee on Aging on November 30, 2011
The AP reports that HHS Inspector General Daniel Levinson proposed that Medicare force nursing homes to pay for inappropriately prescribed drugs, and perhaps drop offending nursing homes from Medicare reimbursement.

Toby Edelman Testifies Before Senate Special Committee Regarding Antipsychotics In Nursing Homes. Testimony of Toby S. Edelman, Senior Policy Attorney, Center for Medicare Advocacy.

The Boston Globe reports that "many hospitals inappropriately use the antipsychotic Haldol" prescribing it "like water" for agitated elderly patients.

The Center for Medicare Advocacy estimates that substantial savings could be achieved if Medicare did not enable the inappropriate use of these powerful drugs. The Office of Inspector General found that more than half of Medicare claims for atypical antipsychotic drugs given to nursing home patients were erroneous, amounting to $161 million in waste during a six month period in 2007. Download Report 1.3 MG.

Nearly 1 in 4 elderly nursing home residents in the United States received antipsychotic agents according to a 2004 study published in the American Journal of Geriatric Pharmacotherapy. Nursing homes with high rates of antipsychotic prescribing in previous years are more likely to administer antipsychotic drugs to newly admitted residents, a UMass Medical School study reported in the January 11, 2010 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Researchers suggest that managing the behavior of elders is the main motivation for using the drugs in nursing homes. Another study reported in the same journal found that physicians who see elderly patients in offices outside of nursing homes have cut back on prescribing antipsychotic drugs patients. In 2005 the FDA began requiring manufacturers of atypical antipsychotics (including Seroquel, Risperdal, and Zyprexa) to include black box warnings of increased mortality risk for older patients with dementia. In 2008 the FDA extended the requirement to conventional antipsychotic drugs. Off-Label Drug Use Is Common and Hurts Nursing Home Residents

An editorial in the February, 2009 Lancet concluded that: "The risks and benefits of prescribing antipsychotics to patients with dementia need to be carefully balanced and these drugs should be used only if alternative strategies do not work. To protect the health and dignity of people with dementia and reduce the use of antipsychotic drugs, approaches that make the needs of patients central to decisions about care should be promoted."

The Government has filed suit against the makers of Risperdol for allegedly "paying millions of dollars in kickbacks" for dispensing drugs to nursing home patients. The Boston Globe reported that Massachusetts joined the lawsuit in March, 2010. More information The manufacturer defended the rebates it dispenses to risperdol prescribers.

A nursing home in Minnesota has had remarkable success finding behavioral, rather than pharmacological, solutions that wean residents off antipsychotic medications. The New York Times reported on the "Awakenings program," and the resident who was freed from three psychotropic drugs: Ativan, Risperdal and an antidepressant. The staff was trained to calm and reassure residents, using activities, music, massage, aromatherapy and “redirecting” conversations.

Convenience of a facility staff is not an acceptable reason for using restraints. Rogers v. Commissioner, 390 Mass. 489, 508 - 509, 458 N.E.2d 308, 320 (1983). Guardianship of Roe, 383 Mass. 415, 443-448, 412 N.E.2d 40, 52, 62 (1981) (few medical procedures are more intrusive than injection of antipsychotic medications).

Under Federal law, patients have the right to be free from:
            any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.
Restraints may only be imposed—
                        (I) to ensure the physical safety of the resident or other residents, and
                        (II) only upon the written order of a physician that specifies the duration and circumstances under which the restraints are to be used.”
42 U.S.C. § 1395i-3(c)(1)(A)(ii)  and 42 U.S.C. § 1396r(c)(1)(A)(ii).

Guidance issued to Surveyors for Long Term Care Facilities by the Centers for Medicare & Medicaid Services lists the serious conditions that justify antipsychotic use, and the inadequate indications for administering antipsychotic medications:

They should not be used if the only indication is one or more of the following: 1) wandering; 2) poor self-care; 3) restlessness; 4) impaired memory; 5) mild anxiety; 6) insomnia; 7) unsociability; 8) inattention or indifference to surroundings; 9) fidgeting; 10) nervousness; 11) uncooperativeness; or 12) verbal expressions or behavior that are not due to the conditions listed under “Indications” and do not represent a danger to the resident or others.
Guidance issued by the Centers for Medicare & Medicaid Services, State Operations Manual, Appendix PP at 387

When antipsychotics are used without monitoring they may be considered unnecessary medications because of inadequate monitoring. Id. at 389.

Dr. Helen Kyomen, a geriatric psychiatrists suggest asking questions when an elder show signs of agitation. Examples:
Is there Overstimulation?
Does the patient have a roommate who intrudes into the patient's personal space excessively?
Is the patient's space overly noisy because of equipment (such as oxygen concentrators or ventilators) or individuals who call out incessantly?
Are staff members rushing in and out of the patient's area as they change shifts?
Understimulation?
Is the patient occupied with appropriately challenging tasks that encourage interest and a sense of mastery?
Is the patient exposed to adequate amounts of sensorimotor stimulation?
Are the day programming, activities, and structure appropriate to the patient's functional capabilities?
Do people or objects trigger stressful memories, drives, or feelings?
Does the patient believe that a family member is responsible for the patient's placement in an extended-care facility?
Does the patient think that a friend who comes to visit at the hospital is able to take him or her home?
Is the patient troubled by a roll belt or other safety restraint?
Are there unmet need?
Is the patient hungry or thirsty?
Does the patient need to b oriented to the facilities or be toileted?
Does the patient need glasses, hearing aids, or similar sensory enhancers?
Helen H. Kyomen, MD, MS, Theodore H. Whitfield, ScD, Agitation in Older Adults, Psychiatric Times (2008)

To read any law review article cited below, open another browser on your computer to the  Massachusetts Trial Court Library, and enter the library’s portal to the Hein Online section, then enter your library card number into the box provided on the portal.  Leave the browser open, and you will be able to open any law review article by pressing CNTRL while right-clicking your cursor over the article title on this page.

The requirements set out in Rogers provide patients in Massachusetts with even greater protection than the protections afforded under Federal laws and regulations.  See: Smith, “Just Say No!” The Right to Refuse Psychotropic Medication in Long-Term Care Facilities 13 Annals Health L 1, 17 – 18 (2004).

Companion services, also known as “sitters,” can serve many functions that benefit a nursing home resident:
In addition to assisting the resident in the performance of menial tasks, such as eating and getting dressed, the mere presence of the sitter may serve as a source of companionship and comfort for the resident. The overall effect on the resident, therefore, may be on an emotional and psychological level, but there is also the possibility that there can be a correlation between sitters and physical restraint use. For example, if reasons for restraint use include a resident's confusion, discomfort, or desire to do something for which there is no available assistance, it seems reasonable that the presence of a sitter could reduce the need for restraint use. The increased presence of a companion could serve as a way for the resident to communicate his discomfort or desires. And even if the resident could not effectively communicate his discomfort, the sitter is more likely to become cognizant of the discomfort by [the companion’s] consistent observations than would a nurse assistant who may see the resident much less frequently.
Meyers, Physical Restraints in Nursing Homes: An Analysis of Quality Care and Legal Liability 10 Elder L. J. 217, 253 - 52 (2002).

the use of physical restraints:
worsens deconditioning, gait, and balance abnormalities, thereby increasing a nursing home resident's fall and injury risk. Other complications of prolonged immobilization include joint contractures; chronic constipation; incontinence; pressure sores; cardiopulmonary deconditioning; increased agitation and confusion; loss of autonomy and dignity; an increased likelihood of contusions, neurovascular compromise, and nosocomial infection; serious biochemical and physiologic effects; abnormal changes in body chemistry, basal metabolic rate and blood volume; orthostatic hypotension; lower extremity edema; bone demineralization; overgrowth of opportunistic organisms; and EEG changes.
Braun & Capezuti, The Legal and Medical Aspects of Physical Restraints and Bed Siderails and Their Relationship to Falls and Fall-Related Injuries in Nursing Homes, 4 DePaul J. Health Care Law, 1, 28 (2000-2001) (citing Federal Register, clinical and geriatric journals) (emphasis added).

Using both physical and chemical restraints can cause additional problems   “If a patient becomes agitated while physically restrained, it may become necessary to sedate the patient; conversely, if a patient is sedated, the patient may need to be restrained because of the patient's decreased physical and cognitive ability.”  Note: Use of Restraints in the Hospital Setting, 22 U. Dayton L. Rev. 149, 152 (1996 – 1997)

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