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The misuse of antipsychotic drugs by nursing homes has been the subject of Congressional hearings and Government reports for many decades.[1]  More than 300,000 nursing home residents take antipsychotic drugs and, as the Inspector General found, most of the use violates federal law.[2]  With funding from the Commonwealth Fund of New York and in cooperation with the Centers for Medicare & Medicaid Services (CMS), the Center for Medicare Advocacy (Center) and Dean Lerner Consulting conducted a study of federal deficiencies cited against nursing facilities for antipsychotic drugs.

Part One of the report, discussed in this Alert, reviewed all antipsychotic drug deficiencies cited in seven states over a two-year period.  The study found that 95% of the deficiencies were described as "no harm," meaning, as described below, that the facilities were unlikely to be sanctioned, regardless of actual effects on residents.  Parts Two and Three, discussed in future Alerts, involved, respectively, the results of a questionnaire sent to surveyors in ten states about how they cite antipsychotic drug deficiencies (and related questions) and recommendations to improve the oversight and enforcement of standards of care involving antipsychotic drugs.

The Federal Survey Process

The federal Nursing Home Reform Law sets out the standards of care that nursing facilities must meet in order to participate in, and be eligible for reimbursement under, the Medicare or Medicaid programs, or both.[3]  The Law also establishes the survey protocol by which state survey agencies determine facilities' compliance with federal standards of care[4] and the enforcement actions that may, or, in some instances, must, be imposed when facilities are determined not to be in substantial compliance with the standards.[5]

Regulations implementing the 1987 Reform Law, in effect since 1990, explicitly limit the use of antipsychotic drugs.  They require that residents not be given antipsychotic drugs "unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record"[6] and that residents taking antipsychotic drugs receive "gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs."[7] 

In the federal survey protocol, which states are required to use, regulatory requirements are identified by "F-tags."  The tag for "unnecessary drugs," which includes antipsychotic drugs, is F329.  The federal survey process classifies deficiencies according to the number of residents affected (scope) and the seriousness of the facility's noncompliance (severity).[8]  A schematic version of the regulation is shown in a 12-box scope and severity grid.[9]  Civil money penalties, one of the federal enforcement remedies, are often limited to deficiencies reflecting a "harm" level of noncompliance – boxes G and above on the scope and severity grid.[10]   

Antipsychotic Drug Deficiencies in Seven States

CMS sent the Center all of the deficiency citations for F329 in 2010 and 2011from seven states: Georgia, Illinois, Massachusetts, Oregon, Pennsylvania, and Texas.  Based on states' surveys, CMS issued 602 F329 citations in these seven states, 295 of which reflected antipsychotic drugs deficiencies.[11]

The primary finding from the analysis of the F329 citations reflecting antipsychotic drugs is that 95% of the deficiencies are cited at a "no harm" level on the scope and severity grid, levels D and E, regardless of the poor outcomes for the residents, the total number or proportion of residents affected by the deficient practice, and the number of federal requirements violated by the facility.  When a deficiency is cited at a "no harm" level, the facility's noncompliance is unlikely to lead to any enforcement action. 

Most of the antipsychotic drug deficiencies (252 out of 295, or 85%), were issued as a result of an annual certification survey; only 46 (or 15%) were issued following a complaint investigation.  However, a higher proportion of complaint investigations resulted in a harm-level deficiency; eight of 15 G-level deficiencies (53%) were cited as a result of a complaint survey.

Harm-level deficiencies were rare.  Only three of the seven states cited any harm-level deficiency in the two-year period and one of the three states cited 11 of the 15 harm-level deficiencies (73%).  Four states did not cite a single harm-level deficiency in 2010 and 2011.

The seven states cited antipsychotic drug deficiencies at different rates.  One state cited one antipsychotic drug deficiency for every 5.3 facilities over the two-year period; another state, one antipsychotic drug deficiency for every 42.2 facilities over the same period.

States varied widely in the factors they considered and whether they evaluated the impact of the drugs on residents.  Some states discussed several residents, facility records, multiple incidents, multiple interviews with staff and residents, whether the resident had a diagnosis supporting the use of antipsychotic drug deficiencies, and a variety of additional factors.  These survey deficiencies often were multiple pages in length.  Other states discussed a single resident and a single incident in less than a page.  Regardless of how the state wrote the deficiency, however, the F329 deficiency was overwhelmingly called no harm.

The full report[12] included examples of deficiencies for each deficiency category from each of the seven states.

No-Harm Deficiencies – Level D

  • Surveyors identified concerns for three of 10 residents who were reviewed for antipsychotic drug use.  One resident was given Zyprexa "for behaviors of resisting care and refusing medications."  The resident had 20 falls.  The consultant pharmacist recommended reducing the resident's Zyprexa, but the physician declined the recommendation.  A second resident was given more than one type of antipsychotic drugs; the physician declined the consultant pharmacist's recommendation about the duplicate therapy.  The third resident was given two different antipsychotic drugs, Seroqual and Zyprexa, both above the daily recommended dosage, as well as PRN [as needed], a third antipsychotic drug, Haldol, intramuscularly.
  • One of 27 residents in the sample was given Haldol, sometimes intramuscularly, sometimes PRN.  As a consequence, the resident fell frequently, breaking several teeth in one fall; declined in activities of daily living (from requiring limited assistance to requiring total care); became incontinent of bowel; and slept frequently (in the dining room, on the floor).

No-Harm Deficiencies – Level E

  • Surveyors documented the facility's failure to monitor and evaluate the side effects of antipsychotic drugs for four of four sampled residents who were given antipsychotic drugs.  A resident who was legally blind and had significant hearing impairment was given Zyprexa for physical aggression during care and for yelling.  Social services questioned whether the resident's aggressive behavior was due to communication difficulties.  The Director of Nursing told surveyors "there are no assessments for psychoactive medications for anyone."
  • Surveyors estimated that 44 of 66 residents on the locked unit routinely received antipsychotic medications.  One resident who spoke only Greek was given Risperdal for agitation/aggression/depression.  His assessment indicated "communication problems may be mistaken as cognitive impairment.  Will not develop Care Plan.  Reason: No special intervention needed."  A second resident who also did not speak English was given Risperdal for behavior disturbance/agitation, but the facility's behavior logs did not document any behavioral issues with the resident.  A third resident was given Seroquel for resisting care, conflict, Alzheimers.  In 10 months, staff documented only three instances of combative behavior, all during toileting.  Surveyors documented that the facility did not follow its own policy on use of antipsychotic drugs.

Harm-Deficiency – Level G

  • Surveyors identified problems for two of four residents who were reviewed for antipsychotic drug use.  One resident, admitted February 9, 2011, had "communication problems due to hearing and vision deficits."  Her husband died March 6.  She was given Seroquel for agitation.  She was hospitalized on April 20 for mental status changes, dehydration, acute renal infection, urinary tract infection (UTI), volume depletion.  She returned to the facility for comfort care and died April 30.  A second resident, also recently widowed, was given Seroquel for agitation and paranoia.  Staff observed her striking her roommate.  After the single incident, staff told the resident's Power of Attorney to move her to another facility.  Surveyors contacted the administrator at the second facility, who told surveyors that his facility was aware of the resident's hitting incident.  The staff did a complete medical work-up of the resident and determined that the resident had a UTI.  The infection was treated and the second facility had "no problems" with the resident.

Conclusion

The misuse of antipsychotic drugs by nursing facilities, when cited, is nearly always described as causing residents no harm.  The result is that CMS only rarely imposes sanctions against facilities that violate federal standards of care.  

Future Alerts will describe how and why surveyors cite antipsychotic drug deficiencies as they do and recommendations from surveyors and project staff that would strengthen facilities' compliance with federal law.

For more information, contact attorney Toby S. Edelman (tedelman@medicareadvocacy.org) in the Center for Medicare Advocacy's Washington, DC office at 202-293-5760.


[1] See the Center's materials on antipsychotic drugs, http://www.medicareadvocacy.org/medicare-info/skilled-nursing-facility-snf-services/antipsychotic-drugs/.
[2] Office of Inspector General, Department of Health and Human Services, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, OEI-07-08-00150 (May 2011), http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf..
[3] 42 U.S.C. §§1395i-3(b)-(d), 1396r(b)-(d), Medicare and Medicaid, respectively.
[4] 42 U.S.C. §§1395i-3(g), 1396r(g).
[5] 42 U.S.C. §§1395i-3(h), 1396r(h).
[6] 42 C.F.R. §483.25(l)(2)(i).
[7] 42 C.F.R. §483.25(l)(2)(ii).
[8] 42 C.F.R. §488.404.
[9] 59 Fed. Reg. 56116, 56183 (Nov. 10, 1994) (final enforcement regulations).  See also State Operations Manual, Chapter 7, §7400.5.1, http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf  (scroll down to pages 91- 93).  The grid is:

 

 

 

Immediate jeopardy to resident health or safety

J

K

L

Actual harm that is not immediate jeopardy

G

H

I

No actual harm with potential for more than minimal harm that is not immediate jeopardy

D

E

F

No actual harm with potential for minimal harm (substantial compliance)

A

B

C

 

Isolated

Pattern

Widespread

[10] State Operations Manual, Chapter 7, §7510, http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf (scroll down to page 113: "The imposition of a civil money penalty may be most appropriate when a facility is not given an opportunity to correct, when immediate jeopardy exists, when noncompliance is at levels G, H, I, or when there is a finding of substandard quality of care.")[11] Other unnecessary drug deficiencies included such problems as failure to monitor residents' Coumadin and giving a resident her roommate's medications
[12] Available at http://www.medicareadvocacy.org/examining-inappropriate-use-of-antipsychotic-drugs-part-one-how-seven-states-cite-antipsychotic-drug-deficiencies//  

 

 

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