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July 26, 2013

Daniel R. Levinson
Inspector General
Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201

Submitted Electronically

Dear Mr. Levinson:

A report today that your office has canceled plans to investigate antipsychotic drug use in nursing homes is disappointing and alarming.

Two years ago we answered your challenge to advocates for nursing home residents to be “outraged” by the massive misuse of antipsychotic drugs in nursing homes and to demand action, and we initiated a meeting with then-CMS Acting Administrator Donald Berwick to urge CMS to make elimination of antipsychotic medication abuse an agency priority. Dr. Berwick ordered agency and industry responses to our concerns that resulted in a national initiative to improve the care of elderly persons with dementia in nursing homes and the enforcement of laws proscribing unnecessary use of drugs and chemical restraints. The power of the Office of Inspector General to have an immediate and positive impact on the care of vulnerable citizens was, we believe, dramatic.

This remains a critical time, however, for the OIG to maintain its oversight of nursing homes and CMS’s enforcement of laws to protect residents against off-label use of medications that sedate and restrain them and put them at risk of serious illnesses and death. The human and financial costs of failure to hold nursing homes accountable are extreme.

As your office reported in May 2011, of 2.1 million elderly persons who lived in nursing homes in the first six months of 2007, almost 305,000 had a prescription for at least one atypical antipsychotic drug. Eighty-eight percent of these prescriptions were for off-label, medically unacceptable uses and/or were associated with a specific FDA Black Box warning against their use by elderly persons with dementia. In all, unapproved uses and improperly documented claims for these drugs cost Medicare $116 million in one six-month period. In a later investigation published in 2012, your office found that 99.5 percent of residents receiving atypical antipsychotic drugs did not have resident assessments and care plans that met federal requirements.

We are pleased that our response to your challenge has had visible, positive results.  However, we are also concerned that without effective oversight, critical problems will not be addressed. Much of the current CMS initiative focuses on a collaborative approach with the industry to set goals and train staff, which will be effective only if providers are also assured that failure to comply will result in swift and meaningful sanctions.

As part of its dementia care initiative, CMS set a modest goal to reduce antipsychotic drug use in nursing homes by 15 percent in the first year. From the first, we have been concerned that trying to attain this goal would obscure the fact that while nursing homes were changing their care practices, they were also required to comply with federal law and regulations prohibiting use of unnecessary drugs and chemical restraints for each resident. The 15 percent goal was only half-met – the for-profit nursing home industry called it “ambitious” [1] – and it has been indefinitely extended. While we support education and training of staff to provide care without psychopharmacologic interventions, an industry that has profitably relied on chemical restraints for the convenience of staff for almost half a century will not change without prompt and meaningful enforcement.

OIG’s announcement in your 2013 operating plan that you would focus on compliance and enforcement was welcomed by our organizations and constituents. While CMS has made improvements in survey guidance and training, oversight will play a critical role in assuring that enforcement actually occurs. There are reasons for concern:

  • Since 2006, antipsychotic drugs have been collapsed under a generic deficiency for unnecessary medication, making them more difficult to cite and target.
  • CMS requires state surveyors to use a confusing and discredited scope and severity grid to cite deficiencies. Under this scheme, deficiencies for sedating residents with dementia with dangerous antipsychotic drugs are almost never cited as actual harm. A recent, not-yet-published report by the Center for Medicare Advocacy raises alarms. It found that 95 percent of more than 300 deficiencies cited in seven states over a two-year period were cited at “no harm” levels, meaning that no penalties were likely to be imposed.
  • With our encouragement, CMS added a quality measure for antipsychotic drug use to Nursing Home Compare. The information now available as a result is invaluable to families evaluating nursing homes’ care, but we are concerned that new quality measures being developed by consultants to CMS will include risk adjustments that will obscure the full extent of inappropriate use.
  • A bill to ensure that residents and their families have a right to informed consent before antipsychotic drugs are administered did not pass in 2012 and has not been reintroduced in Congress this year.

CMS demonstrated deference to powerful industries that manufacture and dispense drugs when it published proposed regulations two years ago to require consultant pharmacists to be free from conflict of interest and acknowledged that residents were being harmed and regulations were needed.  But then, despite public comments documenting a more significant and pervasive problem than CMS had described in the proposed rules, CMS declined to issue final regulations, and chose instead to leave the problem to be self-regulated by the same industries—including nursing homes, pharmaceutical companies, and long-term care pharmacies—that are making billions of dollars off the status quo.

We appreciate the difficult decisions federal agencies face when budgets are reduced. However, we strongly urge you not to abandon your oversight of the misuse of antipsychotic drugs, which have yielded the pharmaceutical industry and long-term care pharmacies billions of misappropriated taxpayer dollars while harming and killing vulnerable elderly adults.


Patricia McGinnis
Michael Connors
Anthony Chicotel
California Advocates for Nursing Home Reform
650 Harrison St., 2nd Floor
San Francisco, CA 94107

Toby Edelman
Center for Medicare Advocacy
1025 Connecticut Ave., NW
Suite 709
Washington, DC 20036

Claire Curry
Legal Aid Justice Center
000 Preston Ave., Suite A
Charlottesville, VA 22903

Richard Mollot
Long Term Care Community Coalition
242 West 30th St., Suite 306
New York, NY 10001

Sarah Wells
Robyn Grant
The National Consumer Voice for Quality Long-Term Care
1001 Connecticut Ave., NW
Suite 425
Washington, DC 20036

Janet Wells
Consumer Advocate & Consultant
4958 Brandywine St., NW
Washington, DC 20016

cc.        Kathleen Sebelius


[1] Neil Pruitt, Board Chair of the American Health Care Association, in an AHCA press release, May 5, 2013.

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