In what has become a disturbingly recurrent pattern, Abbott Labs has agreed to pay $1.6 billion settlement to the federal government and several states for illegally marketing a psychotropic drug as a treatment for dementia (among other things). Abbott’s anti-seizure drug Depakote has no FDA approval as a treatment for dementia nor is there any evidence that it is safe or effective for dementia. In fact, the one clinical trial that Abbott attempted had to stop due to “increased incidence of adverse events.” Nevertheless, Abbott “trained its sales force to promote Depakote to . . . nursing homes,” targeting dementia patients.

As part of the settlement, Abbott pled guilty to misdemeanor misbranding, although it does not appear that any of its executives are going to jail. About $59 million of the settlement is going to California.

While the settlement was widely reported, not many stories mention why Depakote was so eagerly welcomed by nursing home doctors and staff: it comes in a “sprinkle” form that is easy to place surreptitiously in a resident’s food.

The day the settlement was announced, Abbott’s stock price rose ten cents to close at $62.51 per share.

With great support from CANHR and many other advocates, CMS published regulations in October 2011 proposing to require nursing home consultant pharmacists to be independent from long term care pharmacies. CMS then explained that new requirements on independence were needed to help protect nursing home residents from unnecessary use of antipsychotics and other drugs.

On April 12, CMS published a follow-up regulatory package announcing it is ditching the proposal, at least for now. Why the flip-flop?

According to CMS, it still believes that consultant pharmacists should be independent, but is now persuaded that it needs to take more comprehensive steps to stem the misuse of antipsychotic drugs. It wondered out loud, as have we, whether consultant pharmacists in nursing homes are serving any useful purpose at all. Through June 11, 2012, CMS is soliciting public comments on what it should do to help stop the rampant misuse of antipsychotic drugs in nursing homes.

It is too soon to tell if this is pure capitulation to the long-term care pharmacy industry, but it is worth noting that CMS justified its action by saying “it would be significantly disruptive for much of the LTC (long-term care) industry.”

Indeed, disruption of business as usual is exactly what’s needed. In our view, CMS should have adopted the proposed regulations now while also planning more far-reaching reforms.

To its credit, CMS presented a strong analysis of the antipsychotic epidemic, touching on many of the causal factors except its own culpability in fueling the problem through almost unrestricted Medicare and Medicaid payments for these drugs and weak enforcement of pertinent federal nursing home standards. It made a compelling case that comprehensive reform is needed.

Here are some excerpts from the CMS commentary concerning this proposal and its retreat:

• We received extensive comments expressing serious concerns about the level of overuse and inappropriate use of antipsychotic drugs in LTC facilities. A commenter stated that, ‘‘On any given day, over 350,000 nursing home residents receive powerful antipsychotics, despite FDA warnings that the drugs increase the risk of death and studies that show the drugs do not work and have terrible side effects.’’ Many commenters noted the vast majority of those receiving these drugs are residents with dementia who are being chemically restrained when there are safe, effective, and less expensive nonpharmacological methods to care for these residents.

• We share the grave concerns expressed by the commenters concerning the level of antipsychotic drug use in LTC facilities. We believe these comments also call into question the effectiveness of the consultant pharmacists’ drug regimen reviews in curtailing the use and misuse of antipsychotic drugs, regardless of whether the ineffectiveness is caused by inadequate medication reviews by consultant pharmacists or prescribing physicians ignoring the recommended changes.

• Commenters claimed LTC residents’ physicians, as well as the facility’s medical director, rarely see or examine the residents and medications are reordered without the physician reviewing the residents’ condition. According to another commenter, if a resident’s behavior problem escalates, such as in the case of a resident with dementia, facility staff would call the physician to increase the medication dosage, and the physician would commonly comply without seeing the resident.

• Several commenters mentioned the recent investigations of nursing homes conducted by the California Department of Public Health which found that LTC consultant pharmacists failed to identify and report the misuse of antipsychotic medications in 90 percent of the cases identified by investigators as involving inappropriate and potentially lethal doses of these drugs.

• Several commenters explained that consultant pharmacists’ performance evaluations and bonuses were based on the market share of particular brand name drugs in the LTC facility. Thus, as the commenters noted, consultant pharmacists had financial incentives to make medication recommendations that enabled the facility market-share targets to be met.

• Several commenters indicated their LTC pharmacy gave consultant pharmacists a list of ‘‘preferred’’ drugs; that is, drugs for which the LTC pharmacy receives preferred pricing or higher rebates from the pharmaceutical manufacturer, to be used for making their medication recommendations.

• A few commenters described their LTC pharmacy’s therapeutic interchange program, which involves the consultant pharmacist recommending a change from a prescribed non-preferred drug to one of the pharmacy’s preferred drugs. A commenter characterized therapeutic interchange to rebated drugs as ‘‘big business’’ for the pharmacy.

• Many commenters stated that they had first-hand knowledge that LTC pharmacies continue to charge below market rates for the LTC consultant services as a means of acquiring the LTC facility’s pharmacy business, noting that this remains a common practice. Some of these commenters charged that the pharmacies recovered their costs for the consultant pharmacist services by requiring the consultant pharmacists to recommend drugs that generated the highest profit for the pharmacy.

• Many commenters charged that the consultant pharmacists’ drug regimen review quotas were so high that sufficient time was not available to perform a thorough review of the residents’ medication regimens and make good recommendations. One commenter cited a minimum drug regimen review quota of 1,500 reviews per month.

• Some commenters asserted that by limiting the time available to conduct them, the drug regimen reviews were perfunctory. Others described how the drug regimen review requirements were subverted.

• Many of the commenters in opposition to the consultant pharmacist independence requirement noted that conflicts of interest pervade the LTC industry, affecting the facility (which imposes its own formulary requirement to contain costs for the drugs it covers), facility staff (who can encourage the use of chemical restraints to manage residents with behavioral problems), and the residents’ physicians and LTC facility-based prescribers (who may have their own financial ties to the pharmaceutical industry).

• These comments and the data reported by the commenters suggest that the required monthly drug regimen reviews are not yielding the intended outcomes nor are they providing the expected beneficiary protections. If perceived conflict of interest has potentially eroded confidence in the recommendations of the consultant pharmacists that prescribers are ignoring them and the reviews have become merely perfunctory exercises, then we may consider changing the requirements in § 483.60(c) and explore alternative requirements and approaches.

• However, we acknowledge that others in the industry, including LTC facility staff and prescribers, are likewise implicated in the problem of overprescribing and inappropriate drug use. Thus, an independence requirement solely for consultant pharmacists would not solve overutilization and would single out one party, but leave the others to continue unaffected. We agree with commenters that the requirement would be highly disruptive to both LTC facilities and consultant pharmacists with current industry affiliations. Because the proposed requirement does not address the role of facility staff and prescribers in driving overutilization and inappropriate use, it is unlikely to result in substantially reducing these problems that would, in our view, outweigh the costs of industry disruption.

On October 1, 2011, Medi-Cal implemented a little-publicized new policy requiring skilled nursing facilities to jump through new hoops before Medi-Cal will pay for the use of antipsychotic drugs prescribed for residents.

The policy establishes what Medi-Cal calls a “Code I Restriction” for antipsychotic drugs prescribed in skilled nursing facilities. It states that “for all (Medi-Cal) beneficiaries residing within a Skilled Nursing Facility, any antipsychotic medication must now be prescribed for a FDA-approved indication.”

This is a promising development because the FDA has not approved the use of antipsychotics as a treatment for dementia or dementia-related psychosis. Just the opposite is true. The FDA’s June 16, 2008 Alert on this subject states: “Antipsychotics are not indicated for the treatment of dementia-related psychosis.”

Although this would seem to rule out Medi-Cal payment for antipsychotics prescribed for nursing home residents with dementia (except those dually diagnosed with schizophrenia or bipolar), we don’t know what Medi-Cal considers a “FDA-approved indication” or how strictly this policy is being implemented.

Although we’ve often pointed out that Medicare, not Medi-Cal, pays for the vast majority of antipsychotic drugs used in nursing homes, the recent DPH investigations of nursing homes found major misuse of antipsychotics that were paid for by Medi-Cal. The Medi-Cal policy is certainly a step in the right direction and well-worth monitoring.

The broadcast is free and open to anyone, including residents, families, advocates, facility staff, inspectors and others. Click here for information about the event.

Please share this information with anyone who might be interested in this event.

The online video will also be available to the public following its initial airing on March 29.

According to CMS, it is planning to enhance person-centered care for nursing home residents with dementia through a multidimensional approach including research, public reporting, raising public awareness, regulatory oversight and technical assistance/training.

At a national level, CMS manages the Medicare and Medicaid programs and is responsible for enforcing federal nursing home standards. Its promo gives more information on the March 29 kick-off to its new campaign.

CANHR has strongly urged CMS to mount such a campaign and will closely monitor its introduction, goals and impact in the coming months.