CMA Report: Inappropriate Use of Antipsychotic Drugs in Nursing Homes, Part Three – Recommendations to Improve the Citing of Deficiencies
As required by the 1987 federal Nursing Home Reform Law, CMS has developed, tested, and periodically revised a survey protocol that state surveyors, who are generally employed by the state health departments, must use to determine nursing facilities' compliance with federal standards of care. The survey protocol, which is composed of two Appendices to the State Operations Manual, describes the tasks in the survey process that surveyors must perform and establishes Interpretive Guidelines that are CMS's official interpretation of the law and regulations.
The Center for Medicare Advocacy and Dean Lerner Consulting recently studied antipsychotic drug deficiencies in nursing homes. The project, supported by the Commonwealth Fund, had two parts: an analysis of antipsychotic drug deficiencies that were cited in seven states in 2010 and 2011, and the responses by more than 500 surveyors in 10 states to a multi-question questionnaire. This Alert discusses Recommendations, made by surveyors and project staff, for the survey process, surveyor guidance, surveyor training, Requirements of Participation for facilities, and a global recommendation. Some of the Recommendations come directly from surveyors; others are based on recommendations identified in the questionnaire with which many surveyors expressed support.
The most important and frequent recommendation made by surveyors was that they be allowed more time to conduct surveys and identify and classify deficiencies. To help ensure sufficient time for surveys, surveyors recommend that the Centers for Medicare & Medicaid Services (CMS):
- Require a minimum number of surveyors for each team,
- Create specialized teams of experienced and skilled federal surveyors, to be assigned on as-needed basis to states experiencing staffing shortages or other problems (such as failure in enforcement).
Surveyors also seek more federal and state support for their work. They recommend that:
- State supervisors and enforcement staff receive the same training as surveyors do in both the Requirements of Participation and the survey process and that they be required to participate as surveyors in some surveys each year,
- CMS require surveyors to report interference with the survey process to CMS's Central Office.
Surveyor Recommendations for the Survey Process and Surveyor Guidance
With respect to the survey process, surveyors recommend that CMS:
- Require all states to have a pharmacist available to consult with surveyors during the survey,
- Re-establish a separate identifying tag (an "F-tag") for antipsychotic drugs. In 2006, the antipsychotic drug requirements were combined with "unnecessary drugs" into a single F-tag that surveyors use to identify deficiencies. The recommendation is to "unbundle" antipsychotic drugs from unnecessary drugs,
- Reduce and simplify surveyor guidance in SOM.
With respect to the Interpretive Guidelines, surveyors recommend that CMS revise its guidance so that the guidance:
- Is shorter, simpler, more direct, more explicit, and based on real-world deficiencies that were upheld on appeal,
- Is more specific (includes more examples) with respect to determinations of scope and severity,
- Includes a checklist, decision tree, or other type of clearer, more explicit protocol.
With respect to surveyor training, surveyors want:
- More training, more practical training (e.g., how to challenge a physician) by current surveyors, and more in-person training,
- More training in antipsychotic drugs for state agency supervisors, facilities, and prescribers.
Surveyor Recommendations for Requirements of Participation for Facilities
The standards of care that facilities must meet in order to be eligible for reimbursement under the Medicare or Medicaid programs, or both, are called Requirements of Participation. Surveyors recommend that CMS:
- Require physicians to see/examine a patient in person before prescribing antipsychotic drugs,
- Prohibit, or more tightly regulate, as needed (PRN) orders for antipsychotic drugs,
- Require facilities to have a Performance Improvement Project on antipsychotic drugs (as part of QAPI),
- Require mandatory nurse staffing levels.
Project staff also developed a Global Recommendation that would require each facility to complete a new Antipsychotic Drug/Dementia Care Compliance Report for each resident taking antipsychotic drug(s). The facility would be required to identify the resident's diagnosis, all attempted non-pharmaceutical interventions, consents, and recommendations for, and physician responses to, consultant pharmacists' recommendations for gradual dose reductions. The reports would be signed by all members of interdisciplinary team, certifying compliance with all federal Requirements. As part of the annual survey or any relevant complaint survey, surveyors would review the reports.
The misuse of antipsychotic drugs harms and kills residents. When the costs of antipsychotic drugs and the poor outcomes that result from their misuse – including resident falls and hospitalizations – are considered, the misuse also costs hundreds of millions, if not billions, of dollars, each year. Reducing the misuse of these (and other) drugs needs to be a federal priority. Revising the Requirements of Participation to more tightly oversee and control the prescribing of antipsychotic drugs is one step. Another step is strengthening the federal enforcement system so that noncompliance by facilities is more effectively and consistently sanctioned.
For more information, contact attorney Toby Edelman (email@example.com) in the Center for Medicare Advocacy's Washington, DC office at (202) 293-5760.
 42 U.S.C. §§1395i-3(a)-(h), 1396r(a)-(h), Medicare and Medicaid, respectively.
 State Operations Manual, Appendix P, Survey Protocol for Long-Term Care Facilities, at http://cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_p_ltcf.pdf.
 State Operations Manual, Appendix PP, Guidance to Surveyors for Long-Term Care Facilities , at http://cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
 Part One was discussed in CMA, “CMA Report: Examining Inappropriate Use of Antipsychotic Drugs in Nursing Facilities” (Dec. 12, 2013), http://www.medicareadvocacy.org/cma-report-examining-inappropriate-use-of-antipsychotic-drugs-in-nursing-facilities/.
 Part Two was discussed in CMA, “CMA Report: Examining Inappropriate Use of Antipsychotic Drugs in Nursing Facilities” (Jan. 2, 2014), http://www.medicareadvocacy.org/cma-report-on-inappropriate-use-of-antipsychotic-drugs-in-nursing-homes-part-two-what-the-surveyors-say/.
 The full report on Recommendations is available at http://www.medicareadvocacy.org/examining-inappropriate-use-of-antipsychotic-drugs-part-three-recommendations/.
 The Center for Medicare Advocacy has found that almost all deficiencies that are cited are upheld in the administrative appeals process. See CMA,
 42 C.F.R. Part 483.
 Section 6102 of the Affordable Care Act, 42 U.S.C. §1128I(c), requires the Secretary to develop and implement a Quality Assurance and Performance Improvement (QAPI) program by December 31, 2011. CMS has issued guidance on QAPI. See CMA, “Quality Assurance and Performance Improvement (QAPI) Initiatives related to Section 6102 (c) of the Affordable Care Act for Nursing Homes,” S&C: 11-22-NH (April 8, 2011), http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter11_22.pdf; CMA, “Quality Assurance and Performance Improvement (QAPI) in Nursing Homes- Activities Related to QAPI Implementation,” S&C: 12-38-NH (June 29, 2012), http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-12-38.pdf; CMA, “ Preview of Nursing Home Quality Assurance & Performance Improvement (QAPI) Guide – QAPI at a Glance,” S&C: 13-05-NH (Dec. 14, 2012), http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-05.pdf; and CMA, “ Rollout of Quality Assurance and Performance Improvement (QAPI) Materials for Nursing Homes,” S&C: 13-37-NH (June 7, 2013), http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-37.pdf. One requirement of QAPI is development of a Performance Improvement Plan (PIP).
 The Food and Drug Administration (FDA) issued Black Box warnings about the dangers of antipsychotic drugs. An April 2005 warning for atypical antipsychotic drugs cautioned that the drugs increased dementia patient’s mortality. FDA, “Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances” (April 11, 2005), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053171.htm. The warning was extended to conventional antipsychotic drugs in 2008. FDA, “Information for Healthcare Professionals: Conventional Antipsychotics (FDA Alert, June 16, 2008), http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm107211.htm.