Last December the Consumer Voice, along with 93 other national, state and local groups told CMS to publish rules that would require consultants pharmacist in nursing homes to be free of conflict of interest so they could make drug recommendations based on what is best for the residents-not what’s best for the pharmacy companies or drug companies.
This is an open letter to CMS Acting Administrator telling CMS to publish these rules NOW!
June 11, 2012
Marilyn B. Tavenner
Centers for Medicare & Medicaid Services
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
RE: Federal Register, Vol. 77, No. 71. Section II.B.5. Independence of LTC Consultant Pharmacists (S. 483.60)
Dear Ms. Tavenner:
The undersigned organizations representing long-term care residents would like to comment on CMS’s continuing discussion of potential regulatory efforts to address the inappropriate use and overprescribing of drugs, including antipsychotics, which jeopardize residents’ health and often compromise their rights and quality of life with no medical benefit. We strongly supported CMS’s proposal in the October 11, 2011 Federal Register [76 FR 63018] to promulgate rules to require nursing homes to employ consultant pharmacists who are independent of the interests or control of long-term care pharmacies, pharmaceutical manufacturers and distributors, or their affiliates. Therefore, we are both disappointed and deeply concerned that while CMS has concluded that conflict of interest exists, that concerns about its impact on quality of care were “well-founded,” and that “change is necessary,” the agency is now proposing to take a wait-and-see approach to eliminating practices that harm vulnerable Medicare beneficiaries and cost hundreds of millions in misspent Medicare dollars. We strongly urge you to reconsider and to proceed with rule-making to require independent consultant pharmacists and also to take other prompt actions to address very serious problems in prescribing practices that were reported by consultant pharmacists and others during the public comment process.
CMS’s October request for comments recognized that some long-term care (LTC) pharmacies contracting with nursing homes not only sell them drugs but also provide them, at reduced cost, with the services of consultant pharmacists who conduct monthly drug regimen reviews required by Medicare and Medicaid and may recommend alternative drugs to physicians. The LTC pharmacies also receive rebates or preferred costs from pharmaceutical manufacturers for increasing their market share of the drugs used in these facilities. We agreed with CMS that such arrangements create strong incentives for consultant pharmacists to recommend unnecessary and inappropriate drugs. In our comments, we cited separate cases in which a pharmaceutical company, Eli Lilly, and the nation’s largest LTC pharmacy, Omnicare, settled government claims that they illegally promoted atypical antipsychotics to nursing homes to treat (i.e., sedate) residents with dementia. Antipsychotics carry an FDA Black Box warning that they increase the risk of death in persons with dementia.
The Department of Justice alleged that Omnicare received kickbacks from the manufacturer Johnson & Johnson to recommend that nursing homes’ doctors prescribe Risperdal, a drug that increases the risk of heart attacks and strokes in persons with dementia. The government said Omnicare then paid kickbacks to nursing homes by providing them consultant pharmacist services at rates below the fair market value, and it alleged that Johnson & Johnson knew that physicians accepted consultant pharmacists’ recommendations 80 percent of the time and considered them as an “extension of [J&J]’s sales force.”
In your April 12 Federal Register response to public comments [77 FR 22072], you concluded that commenters had corroborated your belief that industry practices pressure pharmacists to recommend certain drugs but also allow them to benefit directly from the rebates and price breaks that pharmaceutical companies give to long-term care pharmacies. Commenters, many of whom were consultant pharmacists or former consultant pharmacists, described practices that “strongly influenced utilization” and “often resulted in a higher number of medications per resident and use of inappropriate drugs”:
• LTC pharmacies gave consultant pharmacists lists of preferred drugs that they were expected to recommend.
• Some pharmacies had “therapeutic change programs” in which consultant pharmacists recommended that prescribers switch to a rebated drug. Automatic prescription changes were generated by the pharmacy when the doctor accepted the recommendation.
• Pharmacists’ performance evaluations and bonuses were based on their LTC pharmacy’s market share of preferred brands.
• Some pharmacies recouped the cost of providing consultant pharmacists to nursing homes by requiring them to recommend drugs that yielded the highest profits.
Commenters described other aspects of the financial relationships among drug manufacturers, LTC pharmacies, nursing homes, and consultant pharmacists that “subvert” drug regimen reviews required to ensure resident safety:
• Quotas and other policies that limit the amount of time consultant pharmacists are allocated to conduct reviews and that make reviews perfunctory.
• Requirements that pharmacists conduct reviews at the pharmacy rather than the nursing home, so they do not have access to medical records.
These reports raise serious concerns that warrant immediate CMS action to ensure the safety of nursing home residents from rampant overuse and misuse of prescription drugs. To delay implementing a protection that you have identified as “necessary” because it would be “highly disruptive to the industry” and “result in higher costs to the facilities and consultant pharmacists” ignores the fact that the industry created the existing system to inflate its profits and shift the costs to beneficiaries and taxpayers. A correction in this system is long overdue.
Commenters noted that the inappropriate relationship between some consultant pharmacists and those who make and sell drugs is not the only factor in the overutilization and misuse of drugs in long-term care facilities. We agree. Our organizations, for example, were among those who pointed out that understaffing, high staff turnover, and poor staff training also contribute to the problem; and we concur that physicians, other healthcare providers, and family members need better education about non-pharmacologic approaches to caring for persons with dementia. However, we do not agree that, because there are multiple factors that influence inappropriate prescribing practices (some of them beyond the scope of CMS’s regulatory responsibility), it would be inappropriate for CMS to address a critical factor that is within its immediate authority and responsibility. CMS also contends that having independent consultant pharmacists would not resolve the problem that “drug regimen reviews may not be yielding the intended outcomes or providing the expected beneficiary protections.” In fact, commenters explicitly related the problems with drug regimen reviews—prescribers’ lack of confidence that consultant pharmacists’ recommendations are in the best interest of residents and high quotas required by LTC pharmacies—to consultant pharmacists’ conflicts of interest with LTC pharmacies and drug manufacturers.
Although we agree with CMS that “consultant pharmacist independence will not solve the whole problem,” it does not follow that CMS should not address any of the problem, especially one this serious. CMS proposes to wait for the industry “to do what is in the best interests of our most vulnerable beneficiaries and implement the necessary and appropriate changes to address this serious situation.” This approach includes encouraging the industry to collect its own data and develop performance measures while CMS monitors the trend in deficiency citations and new nursing home performance measures to see whether there is some unspecified decrease in drug usage that would obviate the need for regulations.
Unfortunately, the financial incentives for the LTC industry to maintain the status quo are likely to overcome any hope of CMS that it will voluntarily desist from lucrative practices and relationships. In May 2011, the Office of the Inspector General said 14 percent of nursing home residents had at least one Medicare claim for an antipsychotic drug, amounting to charges of $309 million in the first half of 2007. During that six-month period, Medicare paid $63 million for antipsychotic drugs that were administered in violation of Medicare standards (for example, provided in excessive doses or for excessive duration). In its case against Johnson & Johnson, the government charged that during a five-year period when the manufacturer paid Omnicare for “active intervention programs,” including consultant pharmacist services, “Omnicare’s annual purchases of J&J drugs increased from approximately $100 million to over $280 million, with the annual purchases of Risperdal alone rising to over $100 million.” Risperdal, an antipsychotic, was only one of many drugs that the government claimed “unjustly enriched” J&J with profits from “illegal inducements” to Omnicare.”
Several of our organizations met with former Acting Administrator Donald Berwick and other CMS officials in September 2011 in a meeting that was instrumental in launching the current CMS initiative to reduce antipsychotic drugs in nursing homes. We believe that provider and consumer education about nonpharmacological alternatives to treat dementia are crucial to the elimination of inappropriate antipsychotic drug use in long-term care. However, educating consumers takes considerable time and is not a substitute for appropriate enforcement of meaningful standards. Even the best educated consumers are often a weak match against the financial incentives that drive poor care in nursing homes. CMS’s proposed approach – “Should marked improvement not occur, we will use future notice and comment rulemaking to propose requirements to address our concerns” –would leave another generation of residents to be harmed by inappropriate medications for which taxpayers foot the bill.
In the brief period since April 12—when CMS published its decision not to move forward on rulemaking on independent pharmacists or other problems identified during the October-December, 2011 comment period—new reports about consultant pharmacist conflicts of interest and their consequences have become public:
• On May 7, Abbott Laboratories reached a $1.5 billion settlement with the Justice Department for promoting off-label use of a psychoactive drug, Depakote, to control agitation and aggression in elderly nursing home residents with dementia, even though it had abandoned its clinical trials of the drug because elderly users were more likely to experience adverse events like somnolence, dehydration and anorexia. The government said, “Abbott created programs and materials to train the pharmacy providers’ consultant pharmacists about the off-label use of Depakote to encourage them to recommend the drug for this unapproved use. Under these contracts, Abbott paid millions of dollars in rebates to the pharmacy providers.”
• On May 31, the California Department of Public Health released a report on 42 investigations of potential inappropriate use of antipsychotics in persons over 55 in nursing homes. Inappropriate use was found in 69 percent of the cases, and in 85 percent of those, consultant pharmacists had failed to identify and report misuse of antipsychotic drugs. The report blamed “knowledge deficits/competency issues” and corporate workload mandates for the pharmacists’ failure identify medication problems. (“Consultant pharmacists stated there is pressure to review 10 to 12 resident charts per hour”—approximately five to six minutes for each resident’s drug regimen review.) Among the facilities that were cited for inappropriate antipsychotic use, “62% (18 of 29) were also cited for receipt of consultant pharmacist services below cost.”
• Based on the comments you received in response to your proposal to regulate the independence of LTC consultant pharmacists and your own narrative on your findings, we strongly urge you to proceed with rule-making to require consultant pharmacists to be independent of the interests or control of long-term care pharmacies, pharmaceutical manufacturers and distributors, or their affiliates. This will not resolve all the problems related to overprescribing and inappropriate drug use in nursing homes, but it will address a problem that jeopardizes the health of hundreds of thousands of elderly persons who live in nursing homes and increases the risk that Congress will transfer more Medicare costs to beneficiaries and taxpayers or reduce benefits.
• CMS should publish regulations that were proposed in 1992, but never finalized, that would require written informed consent prior to the use of antipsychotic drugs.
• CMS itself should collect data on the number, type, and outcome of interventions recommended by consultant pharmacists, rather than creating a new conflict of interest by relying upon the LTC industry to do it voluntarily.
We agree with CMS that a comprehensive approach is needed to address the rampant misuse of antipsychotic drugs with nursing home residents. Among the necessary changes, we recommend that federal regulations must address:
• Physician prescribing practices for antipsychotic drugs. Regulations must require a physician to examine a resident before prescribing antipsychotic drugs and prohibit PRN orders for antipsychotics.
• The role of the medical director. Regulations must assure that the medical director (along with the attending physician and director of nursing, 42 CFR 483.60(c)) review and respond to the pharmacists’ monthly reports on residents’ use of drugs, including antipsychotics.
• Improved survey process. CMS must assure that all state and federal surveyors have training in antipsychotic drugs. It must also require states to employ a sufficient number of pharmacists to participate in surveys, consult with surveyors, and serve on states’ specialized survey teams. CMS must restore a specific F-tag for antipsychotic drugs and revise the Interpretive Guidelines to add examples about antipsychotic drugs.
• Appropriate monitoring of unnecessary drug deficiencies (which include antipsychotic drugs) that are cited by survey agencies. CMS must require all survey reports (2567s) to be sent to CMS to determine whether surveyors need additional training to cite deficiencies at the appropriate scope and severity. (In 1994, when the enforcement system was implemented, CMS required that all 2567s in the country be sent to CMS for analysis.) CMS also should develop data-mining programs to identify nursing facilities with high rates of inappropriate antipsychotic drug use but no deficiencies (or deficiencies cited at a low scope and severity).
The questions you posed in the Federal Register on April 12 should result in additional information and support for eliminating serious deficiencies in the prescribing of medications in nursing homes, and we urge you to move forward promptly to make needed changes in Sec. 483.60 of the regulations after you have analyzed the comments. However, the problems revealed during the 2011 public comment period are serious, and we strongly urge you not to delay the necessary regulatory response.
Thank you for the opportunity to submit comments.
California Advocates for Nursing Home Reform
Center for Medicare Advocacy
GRIOT Circle Inc.
The Community Partnership for Improved Long-Term Care, An Initiative of the Legal Aid Justice Center
Long Term Care Community Coalition
The National Consumer Voice