HHS IG Calls On Drug Makers To Heed Marketing Laws After Report On Rampant Inappropriate Use Of Atypical Antipsychotics In Medicare

HHS Inspector General finds 88% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were used in patients with dementia, despite strict warnings in product labeling.

HHS Inspector General Daniel Levinson is urging drug manufacturers to heed federal laws regarding the promotion of off-label uses of drugs following the release of a report that found a very high rate of inappropriate use of atypical antipsychotics among nursing home residents in Medicare.

Perhaps the most alarming finding of the Office of Inspector General's report is that 88% of the Medicare claims for atypical antipsychotics were for patients with dementia. Labeling for the eight drugs in the atypical antipsychotic class contains a black box warning stating that elderly patients with dementia-related psychoses treated with such a drug are at an increased risk of death. The warning specifically states that atypical antipsychotics are "not approved for the treatment of patients with dementia-related psychosis." They are approved to treat schizophrenia and/or bipolar disorder.

In a column issued in conjunction with the release of the report on May 9, Levinson makes a connection between the inappropriate use to recent cases charging a number of manufacturers with marketing atypical antipsychotics for off-label uses. His column states, "Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety."

He calls on manufacturers to "follow laws designed to protect patients and not promote drugs for unapproved uses - or pay kickbacks to doctors and institutions to influence their prescribing."

The IG does not usually comment separately on reports issued by the office, so Levinson's column suggests he is taking a particular interest in the topic. Sen. Chuck Grassley, R-Iowa, who requested the report in December 2007, and Herb Kohl, D-Wis., are also showing a keen interest by sending a letter to CMS Administrator Don Berwick asking for additional information.

In addition to having general concerns about drug promotion, the two senators had leading roles in creating federal laws for disclosure of pharma/physician financial relationships. CMS is now in the midst of drafting regulations to implement those laws (Also see "Physician Payments Sunshine Rule From CMS Expected By Year's End" - Pink Sheet, 14 Mar, 2011.).

The report, Levinson's column and the senators' letter all call attention to the charges of illegal marketing brought against manufacturers in recent years, citing as examples settlements between the federal government and Eli Lilly and Company with respect to Zyprexa (olanzapine), Bristol-Myers Squibb regarding Abilify (aripiprazole), Pfizer Inc. regarding Geodon (ziprasidone) and AstraZeneca regarding Seroquel (quetiapine), (Also see "AstraZeneca's Seroquel Settlement With DoJ Is Fourth Targeting Antipsychotic Off-Label Promotion; Firm Avoids Criminal Charges" - Pink Sheet, 3 May, 2010.). They also note the ongoing investigation into Johnson & Johnson's practices with Risperdal (risperidone) ('DoJ Claims J&J Paid Kickbacks To Pharmacy To Boost Risperdal Use In Nursing Homes,' 'The Pink Sheet,' Jan. 19, 2010).

The "series of lawsuits and settlements that DHHS helped bring about suggest that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years," Levinson wrote. While the settlements resulted in manufacturers paying billions of dollars to the government, "money can't make up for years of corporate campaigns that market drugs with questionable benefits and potentially deadly side effects for vulnerable, elderly patients," he wrote.

OIG Finds Half Of Claims Were Erroneous

For the report, OIG examined claims submitted through Medicare Part B and Part D for atypical antipsychotics from Jan. 1 through July 30, 2007.

Among the findings were:

- Fourteen percent of elderly nursing home residents had claims for atypical antipsychotics.

- Eighty-three percent of the claims were associated with off-label uses.

- Eighty-eight percent of the claims were associated with patients with dementia.

- Fifty-one percent of the claims were erroneous, meaning they were not used for medically acceptable indications as approved by FDA or described in the recognized compendia or were not documented as having been administered to elderly nursing home residents. These claims cost $116 million.

- Twenty-two percent of the claims were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes, meaning, for example, that they were given in excessive doses or for excessive durations.

The report recommends that CMS take four actions to remedy the discovered problems: 1) facilitate access to information, such as diagnosis, necessary to ensure accurate coverage and reimbursement determinations; 2) assess whether nursing home survey and certification procedures offer adequate safeguards against unnecessary antipsychotic drug use; 3) explore alternative methods beyond survey and certification processes to promote compliance with federal standards regarding unnecessary drug use in nursing homes; 4) take appropriate action regarding the claims associated with erroneous payments identified in the study sample.

In its response to the report, CMS agrees with the recommendations except the first one. Regarding that one, CMS said diagnosis information is not a required data element of pharmacy billing transactions, nor is it generally included on prescriptions, so it is unable to determine whether claims meet payment requirements without a medical review.

Information Requested By Grassley, Kohl

The senators' letter, dated May 6, says they are "troubled" that CMS did not identify specific plans to address OIG's first recommendation.

They request that CMS submit to them a variety of related information, including details on steps the agency will take to protect nursing home residents from unnecessary antipsychotic use, how it will ensure going forward that reimbursements for atypical antipsychotics meet the medically accepted indication standard, what actions it is taking to recoup the erroneous payments identified by OIG, and other options CMS could explore to address the concerns raised in the report. They ask for the agency's response by May 27.

Grassley, now the top ranking Republican on the Judiciary Committee, retains a spot on the Finance Committee with jurisdiction over Medicare, although he gave up his ranking post on Finance. Kohl chairs the Special Committee on Aging.

-Scott Steinke ([email protected])