Friday, April 20, 2012

HHS OIG: 88% Nursing Home Residents w Dementia Antipsychotics DESPITE FDA Boxed Warning

Dateline May 4, 2011

US Dept. of Health and Human Services has;

Complete Report

Download the complete report (PDF)

Adobe® Acrobat® External link is required to read PDF files.

Copies can also be obtained by contacting the Office of Public Affairs at 202-619-1343.


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.

"88 percent were associated with the condition specified in the FDA boxed warning."

And here's the Side Box Related Content HHS article

Overmedication of Nursing Home Patients Troubling

May 9, 2011 By Daniel R. Levinson, Inspector General, Department of Health and Human Services

With 46 million beneficiaries, any issue facing Medicare is a cause for concern.

A government report this week has documented a problem regarding the use of antipsychotic drugs in nursing homes. Too many of these institutions fail to comply with federal regulations designed to prevent overmedication, giving nursing home patients antipsychotic drugs in ways that violate federal standards for unnecessary drug use.

The report also found that these powerful, at times dangerous drugs were often prescribed for uses that are not approved by the Food and Drug Administration and do not qualify as medically accepted for Medicare coverage. Potentially most alarming, 88 percent of the time these drugs were prescribed for elderly patients with dementia, a population the FDA has warned faces an increased risk of death from this class of drugs.

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.

Government, taxpayers, nursing home residents, as well as their families and caregivers should be outraged - and seek solutions.

The Department of Health and Human Services initiated the report when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs, known as "atypical" or "second generation" antipsychotics, replaced (at much higher cost) antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia.

The FDA approves these and other drugs based on scientific proof of safety and effectiveness for specific uses. The agency also reviews scientific evidence to determine what warnings a drug must carry.

For atypical antipsychotics, the FDA imposes its strongest safety warning, often called a "black box warning," emphasizing an increased risk of death when used in elderly people with dementia. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, including to patients for whom the boxed warning applies. Ideally, however, physicians who prescribe in such ways first determine that the benefits outweigh the risks.

The report also found:

  • About 14 percent of nursing home residents, or nearly 305,000, had Medicare claims for these antipsychotic drugs.
  • A little more than half of the antipsychotic drug claims for which Medicare paid should not have been covered because the claimed drugs were not used for medically accepted indications or not documented as provided to patients.
  • For one in five residents, nursing homes dispensed these drugs in a way that violated the government's standards for their use. For example, the prescribed dose was too high or residents were on medication for too long.

Obviously, millions of taxpayer dollars are misspent if the Medicare program is paying for thousands of nursing home residents to get these drugs in violation of program requirements.

And although most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind, it is of great concern that so many nursing home residents are prescribed these drugs in the first place. The report didn't explore this issue, but a 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.

For example, Eli Lilly pled guilty to criminal charges associated with illegally marketing its drug Zyprexa (olanzapine), including to doctors that treat elderly nursing home patients. Several other pharmaceutical companies -- Bristol-Meyers Squibb, Astra Zeneca and Pfizer -- settled government allegations that they improperly promoted their antipsychotic drugs for unapproved uses. Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation's largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

The drug companies have paid billions to resolve these civil and criminal liabilities under federal health and safety laws. But 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.

To solve this problem, everyone has a role to play.

Doctors should base prescribing decisions on their best medical judgments, weighing scientific evidence and an especially careful analysis when they are prescribing drugs for off-label use.

Nursing homes and pharmacies that serve the elderly should base drug-dispensing decisions on the best interest of the patient, not on improper influence of drug companies.

Family members of nursing home residents must ask questions about medications that their loved ones take, learning the reasons for their use, proper dosages and possible side effects.

Government must uphold patient safety standards established for nursing homes and combat off-label promotion of these powerful and potentially lethal drugs.

And drug companies should follow laws designed to protect patients and not promote drugs for unapproved uses -- or pay kickbacks to doctors and institutions to influence their prescribing.

As the huge Baby Boom generation ages, 10,000 Americans a day for the next 18 years will become newly eligible for Medicare. The future is challenging enough; we must not leave unaddressed the current, urgent problem of antipsychotic drug use among nursing home patients.

And this is because the Nursing Home Staff are too Stupid to read the Warnings, Right?

The same way the Doctors are too Stupid to realize that those evil Drug Companies LIED to them.

BTW: There's also an Exclusions Database at the HHS site so you can check out the Quack whose Poisoning your elderly family member in a Nursing Home, if you think it's worth the time to even Bother.

No comments: