Over Prescribed: Antipsychotics Inwards Nursing Homes For Dementia Patients
- Eighty-eight percentage of atypical antipsychotic drugs claims were for nursing domicile residents with dementia.
- 83 percentage of Medicare claims for atypical antipsychotic drugs for elderly nursing domicile residents were prescribed for off-label uses.
- Half of these drug claims should non have got been paid for past times Medicare because the drugs were non used for medically accepted indications.
By
Baca Juga
It is to a greater extent than convenient too less expensive to medicate than it is to hire additional staff, or to amend prepare staff. Non-pharmacological intervention too aid is exactly to a greater extent than expensive.
Meanwhile, at that spot are retentiveness aid units or so the the world that are learning, too so implementing strategies that assist to hold dementia patients happy, easier to bargain with, too to a greater extent than socialized without the utilization of hear numbing medications.
6 Reasons Why You Might Have to Put Someone with Dementia inwards a Memory Care Facility or Nursing Home
What is a Memory Care Facility?
How to Choose a Memory Care or Assisted Living Facility for Your Loved One
Light Exposure inwards Nursing Homes Decreases Sleep Disturbances, Depression too Agitation inwards Alzheimer's Patients
Memory Care Facility
Singing, music, dancing, puzzles, existent exercise, too engaging inwards grouping activities tin plough an "unruly" dementia patient into a wonderfully sweetness person. No its non perfect solution. All of us acquire angry, confused, too fifty-fifty unruly from fourth dimension to time.
I am publishing the total testimony of Daniel R. Levinson Inspector General Department of Health & Human Services to USA Senate Special Committee on Aging below. The testimony is comprehensive too informative on the number of the utilization of Antipsychotics inwards Nursing Homes.
The work is no longer a surreptitious too it has non been a surreptitious for many of us for years.
Something must live done too it must live done now.
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Testimony earlier the United States Senate Special Committee on Aging
“Overprescribed: The Human too Taxpayers' Costs of Antipsychotics inwards Nursing Homes”
Testimony of: Daniel R. Levinson Inspector General U.S. Department of Health too Human Services ______________________________________________________________________________
Good afternoon, Chairman Kohl, Ranking Member Corker, too other distinguished Members of the Committee. I am Daniel Levinson, Inspector General of the U.S. Department of Health too Human Services (HHS or the Department). Thank you lot for the chance to bear witness nearly the HHS Office of Inspector General’s (OIG) function relating to the utilization of antipsychotic drugs inwards nursing homes.
Two recent OIG reports heighten concerns nearly the utilization of atypical antipsychotic drugs1 past times elderly nursing domicile residents, peculiarly those with dementia.
We hired psychiatrists skilful inwards treating elderly patients to review a sample of medical records. Their review revealed the following:
- 14 percentage of nursing domicile residents, or nearly 305,000 patients, had Medicare claims for atypical antipsychotic drugs.
- Half of these drug claims should non have got been paid for past times Medicare because the drugs were non used for medically accepted indications.
- For ane inwards 5 drug claims, nursing homes dispensed these drugs inwards a means that violated the Government’s standards for their use. For example, the prescribed dose was besides high, or residents were on the medication for besides long.
- Part D prescription drug computer program (PDP) sponsors lack access to the information necessary to ensure appropriate reimbursement of Part D drugs, including antipsychotics.
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These findings betoken that Medicare is paying for drugs that it should non too Part D prescription drug plans are non able to adequately preclude inappropriate payments for drugs, including antipsychotics, for uses that attain non run across coverage requirements. In addition, nursing homes often neglect to comply with regulations designed to preclude overmedication of these powerful too at times unsafe drugs.
OIG’s reports also constitute that atypical antipsychotics are oft prescribed “off-label,” that is, for uses that are non approved past times the Food too Drug Administration (FDA). FDA has imposed a rigid security alert on atypical antipsychotics, emphasizing an increased take away chances of expiry when used past times elderly patients with dementia. Yet nosotros constitute that the large bulk of claims for atypical antipsychotics were for elderly patients with dementia. These findings are also troubling given that at that spot is ample evidence that some drug manufacturers have got illegally marketed these drugs for off-label use.
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1 “Atypical antipsychotic drugs” refers to second-generation antipsychotic drugs developed to care for psychoses and/or mood disorders.
2 Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents (OEI-07-08-00150), issued May 2011. Available online at http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf.
Taken collectively, our findings heighten concerns nearly whether atypical antipsychotic drugs are beingness prescribed too monitored appropriately. The Federal Government, wellness aid providers, too families of nursing domicile residents all have got roles to play inwards addressing these issues.
Half of Medicare Atypical Antipsychotic Drug Claims for Nursing Home Residents Did Not Meet Reimbursement Criteria
Atypical antipsychotic drugs that are provided to Medicare beneficiaries, including residents inwards nursing homes, are to a greater extent than often than non covered past times the Medicare Part D program. Although physicians tin prescribe drugs for whatsoever indications, to qualify for Medicare Part D reimbursement, the drugs must live used for medically accepted indications. These indications include both the uses approved past times FDA too those uses (including off-label uses) supported past times ane or to a greater extent than citations inwards the compendia specified inwards the Social Security Act or designated past times the Secretary.
Claims amounting to almost $116 1000000 did non run across Medicare coverage requirements for medically accepted indications
Based on review of a sample of medical records past times skilful psychiatrists, OIG determined that almost 723,000 of the 1.4 1000000 atypical antipsychotic drug claims for elderly nursing domicile residents inwards the kickoff one-half of 2007 did non comply with Medicare reimbursement criteria because they were non used for medically accepted indications. This high payment fault charge per unit of measurement may live partly due to PDP sponsors’ lack of access to information necessary for appropriate reimbursement of Part D drugs.
PDP sponsors lack the information necessary to ensure that Part D drugs claims, including those for antipsychotics, run across coverage requirements
The Centers for Medicare & Medicaid Services (CMS) requires PDP sponsors to ensure that Medicare reimbursement for Part D drugs is express to medically accepted indications. PDP sponsors employ a number of strategies to preclude inappropriate payments for drugs, including prepayment edits, prior authorization, too post-payment review. However, PDP sponsors often cannot create upward one's hear whether a given drug claim was prescribed for a medically accepted indication, because:
- Prescriptions too claims information lack diagnosis information. Without medical tape review, reviewers cannot routinely create upward one's hear why drugs were prescribed.
- FDA label too compendia listings at the fourth dimension of the dispensing, non at the fourth dimension of review, principle eligibility for coverage. Compendia listings tin modify equally oft equally every quarter. For retrospective review, PDP sponsors lack archival information to all compendia to create upward one's hear what indications were listed at the fourth dimension a drug was dispensed.
PDP sponsors have got reported to OIG that they attain non routinely collect diagnosis information because CMS does non require diagnoses equally a information chemical component for Part D claims. PDP sponsors attain non to a greater extent than often than non collect diagnoses for Part D claims from pharmacies because it is non touchstone do for prescribers to furnish them the diagnoses. Without diagnosis information on a Part
D claim, determining whether a drug was provided for a medically accepted indication, too so was reimbursable past times Medicare, is non possible using claims information alone. Sponsors reported to us that they attain collect diagnosis information when using prior authorization, a utilization management tool that requires medical justification for roofing a drug claim. The PDP sponsors indicated that prior authorization is the best tool that they currently have got to compare the diagnosis provided past times the prescriber to the medically accepted indications contained inwards the compendia. However, because antipsychotics are ane of the vi protected drug classes nether Part D, the PDP sponsors indicated that they utilization prior authorization for antipsychotics only inwards express circumstances.
PDP sponsors also reported using post-payment review equally a full general safeguard to preclude fraud too abuse. However, these reviews attain non usually focus on medically accepted indications. PDP sponsors reported that they have got real-time access to all compendia, but attain non have got access to historical data. Because ane of the compendia is published quarterly, it is possible that information nearly a detail drug may live updated betwixt the fourth dimension a drug is provided too the fourth dimension payment review is conducted.
OIG has recommended that CMS facilitate PDP sponsors’ access to information necessary to ensure accurate reimbursement of Part D claims. For example, expansion of the required information elements for Part D claims to include diagnosis codes could assist both drug computer program sponsors too CMS ensure that a drug is used for an FDA-approved indication or a medically accepted indication supported past times the compendia. CMS did non concur with this recommendation, too inwards its comments on our study noted that Congress did non mandate diagnosis information on Part D claims. CMS has also stated that it does non have got statutory say-so to require physicians to include diagnosis information on prescriptions, which are to a greater extent than often than non governed past times State law.
Antipsychotics Are Prescribed inwards Violation of Nursing Home Quality too Safety Standards
As a status of participation inwards Medicare, nursing homes must comply with Federal nursing domicile lineament too security standards. One touchstone requires that nursing domicile residents’ drug regimes live gratis from unnecessary drugs, which CMS defines equally those that are used: (1) inwards excessive dose; (2) for excessive duration; (3) without adequate monitoring; (4) without adequate indications for use; or (5) inwards the presence of adverse consequences that betoken that the dosage should live reduced or discontinued.
Nursing homes’ failure to comply with Federal standards regarding unnecessary drugs may touching their participation inwards Medicare because they would no longer live coming together their weather condition of participation.
However, nursing homes’ noncompliance with these standards does non stimulate Medicare payments for the private drug claims to live erroneous.
Twenty-two percentage of the atypical antipsychotic drugs claimed were non administered inwards accordance with CMS standards regarding unnecessary drug utilization inwards nursing homes
For the 6-month review period, OIG determined that for to a greater extent than than 1 inwards 5 claims (or 317,971 of the 1.4 1000000 Medicare claims), atypical antipsychotic drugs were administered inwards ways that did non run across CMS standards for drug regimens inwards nursing homes. Forty-two percentage of these claimed drugs did non comply with CMS standards for to a greater extent than than ane argue (e.g., the drug was inwards an excessive dose too for an excessive duration).
Failure to comply with CMS standards regarding unnecessary drugs may betoken that nursing homes are non adequately ensuring residents’ wellness too safety. Our medical experts noted instances where nursing domicile beneficiaries were given antipsychotics to command symptoms similar agitation without kickoff receiving a workup to assess whether the symptom mightiness live a sign of some other treatable condition. For example, inwards ane case, a workup of an agitated patient would have got detected a urinary tract infection. Instead of properly diagnosing the urinary tract infection too treating it with antibiotics, the patient was given antipsychotic drugs to command the agitation.
The Vast Majority of Antipsychotic Drug Use inwards Nursing Homes Was Off-Label or Against Black Box Warning
FDA approves drugs based on scientific proof of security too effectiveness for specific uses. If FDA determines that a drug’s wellness benefits for its intended utilization outweigh its known risks, so it approves the drug for marketing for that use. After FDA approves a drug to live marketed for a specific use, so physicians are permitted to prescribe the drug for other uses. This do is non uncommon too is referred to equally off-label use. Medicare pays drug claims for off-label use, provided that the utilization is an accepted medical indication (i.e., supported past times ane or to a greater extent than citations inwards a designated compendia). However, although physicians may prescribe off-label, drug manufacturers are non permitted to promote off-label uses of their drugs.
FDA also reviews scientific evidence to create upward one's hear what warnings a drug must carry. If a drug manufacturer or FDA determines that an approved drug may attain severe or life-threatening risks, so FDA requires that the manufacturer include a boxed alert (also referred to equally a black-box warning) on the product’s labeling to warn prescribers too consumers of these risks. Nevertheless, physicians are permitted to prescribe a drug for a patient with a status specified inwards a boxed alert if such a handling therapy is warranted inwards their clinical judgment. Atypical antipsychotic drugs send a black-box alert emphasizing an increased take away chances of expiry when used inwards elderly people with dementia.
Some manufacturers have got illegally marketed antipsychotics for patients with dementia
Despite the fact that elderly dementia patients who are treated with atypical antipsychotics aspect upward an increased take away chances of death, ample evidence exists that some drug companies have got illegally marketed their products toward this vulnerable population for off-label uses. For example, with the sales slogan “5 at 5,” Eli Lilly promoted its atypical antipsychotic, Zyprexa, for the handling of elderly patients with slumber problems, behavioral issues, too dementia. The companionship directed its sales representatives to tell doctors that giving 5 milligrams of the drug at 5 pm would assist their patients sleep. In Jan 2009, Eli Lilly agreed to plead guilty too paid $1.4 billion for the illegal advertisement of Zyprexa.
Several other pharmaceutical companies have got settled Government allegations that they improperly promoted their antipsychotic drugs for unapproved uses and/or have got paid kickbacks to influence prescribing. Drug companies have got paid to a greater extent than than a billion dollars to resolve civil too criminal liability for illegally marketing these drugs. Even after government activeness stops these illegal marketing campaigns, their effect on prescribing patterns may live long-lasting too hard to undo.
Off-label utilization too utilization of atypical antipsychotics for patients with dementia were prevalent with nursing domicile residents
Based on a review of a sample of medical records past times medical experts, OIG determined that 83 percentage of Medicare claims for atypical antipsychotic drugs for elderly nursing domicile residents were prescribed for off-label uses. Eighty-eight percentage of atypical antipsychotic drugs claims were for residents with dementia, the status specified inwards the boxed warning.
Physicians are permitted to prescribe drugs for off-label weather condition or inwards the presence of the condition(s) specified inwards the FDA boxed warning. Such prescribing may live medically appropriate despite the risks – inwards fact, off-label prescribing is mutual for many classes of drugs.
However, our findings heighten concerns. Through our enforcement too compliance monitoring activities, OIG has identified inappropriate utilization of psychotropic medications for nursing domicile residents equally a take away chances expanse inwards at to the lowest degree 2 ways—inappropriate uses such equally those identified through OIG’s function may violate the prohibition against inappropriate utilization of chemic restraints too the requirement to avoid unnecessary drug usage. OIG has issued guidance to nursing facilities on risks related to psychotropic medications (a category which includes antipsychotics).3 These risks include:
- use for staff convenience rather than providing appropriate non-pharmacological interventions;
- use without kickoff determining the causal too contributing factors of the behavior;
- lack of specific too individualized aid plans;
- lack of continued monitoring of the require for or the amount of the medication; and
- inappropriate admission of residents with mental wellness diagnoses that the facility is non prepared to treat.
In lite of these risks, nosotros recommended that nursing facilities ensure at that spot is an adequate indication for the utilization of the medication too should carefully monitor, document, too review the utilization of each resident’s psychotropic drugs.
Recommendations to Protect Nursing Home Patients From Unnecessary Drug Use
Medication therapy for nursing domicile residents is often complex. Many residents have got multiple weather condition that require management with multiple medications, equally good equally non-pharmacological interventions. Most physicians too nursing homes dispense antipsychotic drugs with the best interests of patients inwards mind. Physicians are permitted to prescribe drugs for unapproved indications, fifty-fifty inwards lite of a black-box warning, but should utilization their best clinical judgment to create upward one's hear that the benefits outweigh the risks.
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3 OIG’s Supplemental Compliance Program Guidance for Nursing Facilities is available online at: http://oig.hhs.gov/compliance/compliance-guidance/docs/complianceguidance/nhg_fr.pdf.
However, OIG has constitute that all besides often, nursing domicile patients have antipsychotic drugs inwards ways that violate Federal standards designed to preclude overmedication too inappropriate use.
To ensure the security of this vulnerable population, CMS should:
- Consider enhancing claims information to ensure accurate coverage too reimbursement determinations. For example, adding diagnosis codes to drug claims would assist create upward one's hear whether the prescription is for a medically accepted indication too the claim is payable.
- Hold nursing homes accountable for unnecessary drug utilization through the survey too certification process.
- Explore other options, such equally incentive programs too provider education, to promote compliance with lineament too security standards. For example, CMS could require nursing homes to reimburse the Part D computer program when claimed drugs violate these standards.
The Government must also proceed to monitor the marketing of antipsychotics. Some drug manufacturers have got promoted these drugs for off-label utilization past times the elderly with dementia. These practices tin violate the constabulary too fifty-fifty if the drug companionship is fined, the pernicious influence of such marketing campaigns tin live hard to undo.
Doctors, pharmacists, too nursing homes must carefully analyze the patient’s best interests when prescribing or dispensing antipsychotics. Families, inwards partnership with these medical professionals, tin serve equally a crucial back upward past times learning nearly appropriate use, proper dosages, too possible side effects of these drugs.
My component division continues to examine protections too lineament of aid for patients who are receiving antipsychotic drugs. The extensive prescribing of these drugs too the concerning instance examples nosotros have got encountered inwards the course of instruction of this function heighten serious questions nearly whether nursing domicile residents are receiving high-quality, coordinated care. To farther explore this issue, nosotros are currently conducting a novel review that volition create upward one's hear whether nursing facility patients taking atypical antipsychotic drugs have got received the required patient assessments too thorough aid planning that Federal standards require.
CONCLUSION
Over the side past times side eighteen years, 10,000 Americans volition expire newly eligible for Medicare each day. As the babe boomer population ages, it is imperative to address the overuse too misuse of antipsychotic drugs with nursing domicile patients. Thank you lot for your involvement inwards this number too for your back upward of OIG’s mission.
http://oig.hhs.gov/testimony/docs/2011/levinson_testimony_11302011.pdf
http://oig.hhs.gov/
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