Wednesday May 4, 2011
Report: OEI-07-08-00150
05-04-2011
For the period January 1 through June 30, 2007, we determined
using medical record review that 51 percent of Medicare claims for
atypical antipsychotic drugs were erroneous, amounting to $116
million.
A member of Congress requested that OIG evaluate the extent to
which elderly nursing home residents receive atypical antipsychotic
drugs and the associated cost to Medicare. Specifically, this
member expressed concern with atypical antipsychotic drugs
prescribed to elderly nursing home residents for off-label
conditions (i.e., conditions other than schizophrenia and/or
bipolar disorder) and/or in the presence of the condition specified
in the Food and Drug Administration's (FDA) boxed warning (i.e.,
dementia). Medicare requires that drugs be prescribed for
"medically accepted indications" for reimbursement. Further, CMS
sets standards to ensure that nursing home residents' drug therapy
regimens are free from unnecessary drugs.
We also found that 14 percent of the 2.1 million elderly (i.e.,
age 65 and older) nursing home residents had at least 1 claim for
these drugs. We determined using medical record review that 83
percent of Medicare claims for atypical antipsychotic drugs for
elderly nursing home residents were associated with off-label
conditions and that 88 percent were associated with the condition
specified in the FDA boxed warning. We further determined through
medical record review that 22 percent of the atypical antipsychotic
drugs associated with the claims were not administered in
compliance with CMS standards regarding unnecessary drugs in
nursing homes, amounting to $63 million. Nursing homes' failure to
comply with these standards may affect their participation in
Medicare. However, nursing homes' noncompliance with these
standards does not cause Medicare payments for these drugs to be
erroneous.
To ensure that Medicare correctly pays for atypical
antipsychotic drugs and that elderly nursing home residents are
free from unnecessary drugs, we recommend that CMS (1) facilitate
access to information necessary to ensure accurate coverage and
reimbursement determinations, (2) assess whether survey and
certification processes offer adequate safeguards against
unnecessary antipsychotic drug use in nursing homes, (3) explore
alternative methods beyond survey and certification processes to
promote compliance with Federal standards regarding unnecessary
drug use in nursing homes, and (4) take appropriate action
regarding the claims associated with erroneous payments identified
in our sample.
In its written comments on the report, CMS shared our concern
and that of Congress over whether atypical antipsychotics and other
drugs are being appropriately prescribed for elderly nursing home
residents. CMS concurred with the second, third, and fourth
recommendations; however, CMS did not concur with the first
recommendation and expressed several general concerns with the
report.
CMS did not concur with the first recommendation, stating that
diagnosis information is not a required data element of pharmacy
billing transactions nor is it generally included on prescriptions.
OIG recognizes that the industry has not developed a standardized
way of collecting diagnosis information for prescription drugs.
However, without access to diagnosis information, CMS cannot
determine the indications for which drugs were used. For this
reason, CMS is unable, absent a medical review, to determine
whether claims meet payment requirements.
Although CMS concurred with the second recommendation, we
further recommend that CMS use its authority through the survey and
certification processes to hold nursing homes accountable when
unnecessary drug use is detected.
Although CMS concurred with the third recommendation, it did not
believe some of the examples of alternative methods to promote
compliance provided in the report to be practicable. We suggest
that CMS either use its existing authority or seek new statutory
authority to prevent payment and hold nursing homes responsible for
submitting claims for drugs that are not administered according to
CMS's standards regarding unnecessary drug use in nursing
homes.
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