Capsule NewsSM
A Newsletter for Montana Health Care Providers

Second Quarter 2014

BCBSMT to continue use of existing conversion factor and 2013 CMS RVUs

On Feb. 1, 2014, Blue Cross and Blue Shield of Montana (BCBSMT) provided notice to providers that for 2014, BCBSMT had made the business decision to postpone the effective date of its provider fee schedule update to Sept. 1, 2014. Typically, provider fee schedule updates become effective May 1.

BCBSMT routinely analyzes all facets of the provider compensation structure so that it can continue to offer reasonably priced health care insurance that allows access to high-quality, affordable health care. As many providers may be aware, the Centers for Medicare and Medicaid Services (CMS) published the 2014 CMS RVUs in the Federal Register on Nov. 25, 2013. Historically, CMS has routinely adjusted the annual RVU update to achieve targeted budget neutrality. Unfortunately, this year the CMS adjustments contained unprecedented decreases in the valuations of the RVUs. BCBSMT's analysis shows that there was an overall decrease of approximately 4.9% in the value of the RVUs.

In the consideration of these facts, for the remainder of 2014 and into the first quarter of 2015, BCBSMT will continue with the existing conversion factor and the 2013 CMS RVUs. New CPT codes that became effective Jan. 1, 2014, have been added to the existing provider fee schedule, and have been priced using the existing conversion factor. BCBSMT will not implement the 2014 CMS RVUs.

BCBSMT values our providers' continued participation in our provider networks and values their daily efforts to provide high-quality affordable health care for our BCBSMT groups and members. For more information regarding this communication, please call or email your Provider Network Representatives:

Susan Lasich
406-437-6223
susan_lasich@bcbsmt.com

Christy McCauley, HCAFA
406-437-6068
Christy_mccauley@bcbsmt.com

Julie Sakaguchi, CPC, CPC-H
406-437-6122
julie_sakaguchi@bcbsmt.com

Jenifer Sampson, CPC
406-437-6121
jenifer_sampson@bcbsmt.com

2013 HEDIS results now posted on our website

HEDIS® (Healthcare Effectiveness Data and Information Set) is the gold standard in health care performance measurement and is used by more than 90 percent of the nation's health plans as well as many leading employers and regulators. HEDIS uses a set of standardized measures that specify how organizations collect, audit, and report performance information. The measures include evaluation of clinical area performance, as well as important dimensions of customer satisfaction and patient experience. Examples of the measures we report are: Comprehensive Diabetes Care, Childhood and Adolescents Immunizations, and Cholesterol Management.

Why does Blue Cross and Blue Shield of Montana gather HEDIS data?

  • State law 33-36-101, et seq., Managed Care Plan Network Adequacy and Quality Assurance Act, requires that any managed care organization operating in Montana meet minimum standards of network adequacy and quality of care.
  • The use of HEDIS data allows BCBSMT to demonstrate to our members, providers, and others the performance of our provider networks relative to other managed care organizations operating in Montana and nationally.
  • HEDIS data allows the Associated Managed Care Organizations to identify opportunities for improvement and implement appropriate interventions.

Where can I locate the HEDIS data?

The report showing the past three years aggregate results are posted on our website at BCBSMT.com. If you have any questions regarding the data please contact our HEDIS coordinator at the number listed below. Providers may also request to have their individual results sent to them in a separate report.

If you wish to have your individual results mailed to you, or, if you have any questions regarding the data please contact Nancy Hamilton, HEDIS Coordinator, at 406-437-6476.

We would like to thank all of the providers and clinic staff that participated in this year survey. Without all of you we would not be able to report this data. We will be kicking off our new HEDIS year starting in May. Please look for our request for information coming soon.

Have you received a call about updating your information?

Blue Cross and Blue Shield of Montana (BCBSMT) is working with a company called Thoroughbred Research Group to help ensure our Provider Finder® has the most accurate and current information about BCBSMT providers. You may receive a call from Thoroughbred Research Group in May and/or June of 2014, with operators asking to verify information published in our provider directory.

If you receive a call from Thoroughbred Research Group on behalf of BCBSMT, please help us by confirming whether or not your information is current. We appreciate your help in making our Provider Finder as accurate as possible for members and providers.

BCBSMT makes no endorsement, representations or warranties regarding any products or services offered by Thoroughbred Research, a third party vendor. The vendor is solely responsible for the products or services offered by them. If you have any questions regarding the services offered here, you should contact the vendor directly.

A Closer Look: Documentation and Coding for Cardiac Conditions

Previous issues of the Capsule News reviewed coding and documentation practices for pulmonary diagnoses, diabetes, chronic kidney disease, and behavioral health disorders. This month we will be posting an article on our Provider website that will take a closer look at coding for cardiac conditions.

Heart disease is a broad term used to describe a range of diseases that affect the heart. The various ailments that fall under the umbrella of heart disease include diseases of the heart and blood vessels. The term "heart disease" is often used interchangeably with "cardiovascular disease." Cardiovascular disease generally refers to conditions that involve narrowed or blocked blood vessels that can lead to a heart attack, angina or stroke. There are other heart conditions, such as infections and conditions that affect the heart's muscle, including valves or beating rhythm, which are also considered forms of heart disease. All types of heart disease share common traits, but they also have key differences.

The article on our website may help you better understand documentation and diagnosis coding for conditions that fall under the cardiac conditions umbrella. It also addresses the importance of providing supporting documentation to facilitate accurate and complete compliance diagnosis code assignments for the described heart conditions.

For more information about Coding for Cardiac Conditions, read the extended article and related documentation case studies by visiting the Related Resources/Risk Adjustment section of our Provider website at bcbsmt.com/provider.

This material is for educational purposes only and is not intended to dictate what codes should be used in submitting claims. Health care providers are instructed to use the most appropriate codes based upon the medical record documentation and coding guidelines.

ICD-10 Update

In April, President Obama signed into law H.R. 4302, the "Protecting Access to Medicare Act." Included in the law is a provision that delays the implementation of ICD-9 to ICD-10 until at least Oct. 1, 2015.

BCBSMT had planned to begin ICD-10 testing with providers starting this month. As a result of this delay, BCBSMT will pause provider testing and other implementation activities until a new compliance date is announced. We have made significant progress over the last several years in readying our systems. BCBSMT is well positioned to complete the remaining scope of work once a new implementation date is announced, including end-to-end provider testing.

As more information about the new compliance date becomes available, BCBSMT will continue to provide updates in the Capsule News and on the provider website.

This material is for educational purposes only and is not intended to dictate what codes should be used in submitting claims. Health care providers are instructed to use the most appropriate codes based upon the medical record documentation and coding guidelines.

Reminder: Confirm Network Participation and Patient Eligibility

This is the first year, pursuant to the Affordable Care Act (ACA), that all U.S. citizens have the right to obtain health insurance coverage. It may be the first time many of your patients have health care coverage. BCBSMT is educating its new members about their coverage and how to use it, but we have observed that some members may be unaware of the requirement to obtain services from an in-network provider to help maximize benefits paid under their plan. We want to stress the importance of confirming your network status with respect to your patients' plan of coverage before you provide services. As a reminder, the terms of your network contract with BCBSMT prevent you from refusing to provide services to a BCBSMT member, regardless of where they purchased their coverage.

Confirming Network Participation

The member's ID card displays the name of their coverage plan. Your contract with BCBSMT will indicate the plan or network(s) in which you participate. You can also view your network participation on our Provider Finder® located on our Provider website (see the instructions below for accessing and using Provider Finder®), or ask your BCBSMT network representative.

If a BCBSMT member arrives for an appointment and is out-of-network, you should inform the member that you are not within his or her plan's network. If the member requests that you provide treatment, inform the member that your services will likely cause them to incur out-of-pocket costs and they could be financially responsible for up to 100 percent of the services received. Care provided for emergency conditions, however, will be processed and paid the same regardless of whether the provider is in- or out-of-network.

Referrals

A referral should direct your patient to an in-network provider whenever possible. While you may have an established list of colleagues for referrals, the addition of new networks makes it important for you to confirm whether they are an in-network provider for your patient's plan. Referring your patient to an out-of-network provider may result in your patient receiving lesser out-of-network benefits and incurring higher out-of-pocket costs. In some circumstances, your patient may be financially liable for the full cost of the services rendered by an out-of-network provider.

You can utilize Provider Finder® on our Provider website to locate in-network providers and facilities:

  • Select the "Network Type" from the drop down list
  • Select "Provider Type," "Specialty," or both
  • Click "Find" to see a list of all participants in that network type
  • Check the Provider Finder regularly

Checking Eligibility and Benefits is Important

As always, verifying eligibility and benefits is a critical first step before providing services to new and existing patients. Ask to see your patient's member ID card before/upon the first visit and every visit thereafter.

The following are some reasons why this process is important for every visit, even if multiple visits were approved:

  • Patients may change or cancel their individual policy or their employer provided group coverage
  • Policies and benefits may change during the course of treatment
  • Copays and coinsurance may vary by product/plan

Information about BCBSMT networks, products and policies is regularly published in the Capsule News and on our website at bcbsmt.com.

Verification of eligibility and/or benefit information is not a guarantee of payment. Benefits will be determined once a claim is received and will be based upon, among other things, the member's eligibility, any claims received during the interim period and the terms of the member's certificate of coverage applicable on the date services were rendered.

Updated: Medicare Crossover Claims Submission Reminder

Blue Cross and Blue Shield Plans have been using the Centers for Medicare and Medicaid Services (CMS) crossover process to receive Medicare primary claims since January 2006. The CMS crossover process routes Medicare Supplemental claims (Medigap and Medicare Supplemental) directly from Medicare to BCBSMT so that providers do not need to also submit the claim to BCBSMT. Over the years, this Medicare crossover process has helped increase efficiency by requiring one claim submission, reducing duplicate submissions, improving payment accuracy, and increasing member and provider satisfaction.

Although the above process is clear, providers have continued to submit the claim to both Medicare and BCBSMT resulting in duplicate claims. These duplicate claims result in additional, unnecessary work and possible inaccurate claims processing, which in turn has a negative impact on providers, members and Plans.

When the Home Plan receives a Medicare Primary claim before it is crossed over, it may be incorrectly paid based on an estimated Explanation of Medicare Benefits (EOMB). Provider payment should be calculated based on the actual EOMB. Members are also impacted when providers submit duplicate claims. When the Home Plan uses an estimated EOMB, they may incorrectly calculate member cost sharing.

In an effort to improve the Medicare crossover administrative process, all providers are instructed to follow new rules concerning Medicare secondary claim submission. When a claim has been crossed over, providers are to wait 30 calendar days from the initial Medicare remittance date before submitting the claim to BCBSMT.

As a reminder, effective Oct. 13, 2013, claims received on or after that date could potentially be impacted. BCBSMT will reject provider submitted claims when Medicare is considered primary including those with Medicare exhausted-benefits that have crossed over if they are received within 30 calendar days of the initial remittance date or with no Medicare remittance date. It is expected that this modification will address duplicate claim submissions.

How do I submit a claim when Medicare is primary and Blue Plan is secondary?

  • Submit claims to your Medicare carrier when Medicare is considered primary and the Blue Plan is secondary.
  • When submitting the claim, it is essential that you enter the correct Blue Plan name as the secondary carrier. This may be different from the local Blue Plan. Check the member's ID card for additional verification.
  • Be sure to include the alpha prefix as part of the member number. This alpha prefix is located on the members ID card as the first three characters. The alpha prefix is critical for confirming membership and coverage, and if not provided, may delay payments.

When you receive the remittance advice from Medicare, determine if the claim has been automatically forwarded (crossed over) to the Blue Plan:

  • Remark codes MA18 or N89 on the Medicare remittance will indicate that the claim was crossed over. The claim has been sent on your behalf to the appropriate Blue Plan for processing. You do not need to resubmit that claim to BCBSMT.
  • If the remittance indicates that the claim was not crossed over, submit the claim to BCBSMT with the Medicare remittance advice.
  • In some cases, the member ID card may include a Coordination of Benefits Agreement ID number. If so, be certain to include that number on your claim.

If you have any questions or need to request the status of a claim, inquiries should be submitted in the following manner:

  • Electronically — send a HIPAA transaction 276 (claim status inquiry) to BCBSMT through your preferred online vendor portal.
  • By phone — call our Interactive Voice Response (IVR) automated phone system at 800-447-7828.

When should I expect to receive payment?

The claims you submit to the Medicare carrier will be crossed over to the Blue Plan only after they have been processed by the Medicare intermediary. This process may take approximately 14 business days to occur. This means that Medicare will be releasing the claim to the Blue Plan for processing about the same time you receive the Medicare remittance advice. As a result, upon receipt of the remittance advice from Medicare, it may take up to 30 additional business days for you to receive payment or instructions from the Blue Plan.

What should I do in the meantime?

If you submitted the claim to the Medicare carrier, and haven't received a response to your initial claim submission, do not automatically submit another claim. Rather, you should:

  • Review the automated resubmission cycle on your claim system.
  • Wait 30 calendar days from receipt of the Medicare Remittance advice.
  • To avoid submitting a duplicate claim, check the status of the initial claim before resubmitting.

If you use a billing service or clearinghouse to submit claims on your behalf, please be sure they are aware of this information. For more information about submitting claims or checking the status of a claim, visit the Claims and Eligibility section.

In the Know: Talk to Your Patients about Medication Adherence

Adherence to medications used within patient treatment plans is vital to successful outcomes. On the average, however, studies have shown that 50 percent of medications for chronic conditions are not taken as prescribed, if they are taken at all.1 Adverse effects may not be immediate, but non-adherence with prescriber instructions may be detrimental to a patient's health over time. For example, in a study by Gehi, et al, patients who self-reported being non-adherent (taking their medications as prescribed 75 percent of the time or less) were more likely than adherent patients to develop cardiovascular events during 3.9 years of follow-up.2

Your patients may not understand how taking their medications diligently, as prescribed, can affect their overall health. When screening your patients for medication adherence, consider asking open-ended questions verbally, or on intake paperwork, such as: How many doses of your medication did you miss within the past week? Encouraging honesty can lend insight into perceived barriers your patients may be facing so that you may help address their concerns. Explaining desired results of therapy and verbally confirming your patients' understanding of directions can help increase awareness and ultimately may affect their treatment outcomes.

References:

  1. Harold, John Gordon. American College of Cardiology, ACC In Touch Blog. Posted July 10, 2013. Script Your Future Initiative Continues to Offer Opportunities to Reach Heart Patients with Medication Adherence Messages. Retrieved from http://blog.cardiosource.org/post/script-your-future-initiative-continues-to-offer-opportunities-to-reach-heart-patients-with-medication-adherence-messages/ 
  2. Gehi, Anil K; Ali, Sadia; Na, Beeya; Whooley, Mary A. Self-reported Medication Adherence and Cardiovascular Events in Patients with Stable Coronary Heart Disease: The Heart and Soul Study. Arch Intern Med. Sept. 10, 2007; 167(16):1798-1803.

The information mentioned here is for informational purposes only and is not a substitute for the independent medical judgment of a physician. Physicians are instructed to exercise their own medical judgment. Members should refer to their certificate of coverage for more details, including benefits, limitations and exclusions. Regardless of benefits, the final decision about any medication is between the member and their health care provider.

Modifier 59 Policy Changes with ClaimsXten™

Effective July 1, 2014, the 59 modifier override will process according to NCCI guidelines for bypassing ClaimsXten (CXT) edits for claims processing using the CXT code editing software for converted member claims.

NCCI guidelines state, "Each NCCI edit has an assigned modifier indicator. A modifier indicator of '0' indicates that NCCI associated modifiers cannot be used to bypass the edit."

BCBSMT will continue to use CXT as the code pair default. NCCI edits (either Incidental or Mutually Exclusive) that are currently not part of the CXT database will not be added.

To help determine how coding combinations on a particular claim may be evaluated during the claims adjudication process, you may continue to use Clear Claim Connection™ (C3). C3 is a free, online reference tool that mirrors the logic behind BCBSMT's code auditing software. Refer to our website at bcbsmt.com/provider/claims-and-eligibility/claims-xten for additional information on gaining access to C3.

For claims processing using the iCES code editing software for non-converted member claims, continue to refer to the Modifier 59 Compensation Policy. Refer to the policy link for a list of code combinations BCBSMT allows 59 modifier to bypass an iCES edit.

Clear Claim Connection™ and ClaimsXten are trademarks of McKesson Information Solutions, Inc., an independent contractor.

'Go Wild with Berries' and Other Healthy Living Resources

New for Spring

eCards for Health® is a free, online health and wellness resource for BCBSMT members and the general public that offers a selection of eCards, screen savers and tips for a healthy living. It is designed to inspire the reader to commit to small, healthy behavior changes and share their commitments with those they care about. eCards for Health offers creative online tools to promote healthier lifestyles which you can discuss with your patients.

This month, users can visit the eCards for Health website at ecardsforhealth.com to download Go Wild with Berries, a free new screen saver that invites viewers to make berries a theme ingredient in spring dishes and highlights some key ways berries can contribute to a healthy diet. Encourage your patients to check out the eCards for Health site for helpful tips for healthy living.

Look for us on Twitter and Facebook

BCBSMT uses social media tools such as Facebook, Twitter and YouTube to share healthy living and wellness messages with members and the public. Each month, our Social Media team posts an array of messages that support current health topics and national health observances, while hosting sweepstakes and live chats promoting healthy living for our fans and followers. Social media adds a unique, often personal dimension to the conversation because it enables individuals to ask us questions and share their thoughts and experiences directly with others.

Check it out for yourself and talk to your patients about our social media resources on:

These programs are for informational purposes only, and are not a substitute for the sound medical judgment of a physician or other health care professional. Members are encouraged to talk to their doctor if they have any questions or concerns regarding their health.

Medicare Part D Drug News Updates

Acetaminophen (APAP) Overuse: Risks, Developments, and Recommendations

Introduction

Acetaminophen (APAP) is a common household drug used for its analgesic and antipyretic properties. Recent evidence and discussions, however, have illuminated the myriad hazards and contributing factors associated with APAP overuse of both prescription and over-the-counter (OTC) products. Whether intentional or unintentional, APAP consumed in excess of 4 grams per day is associated with increased morbidity and mortality.

A known hepatotoxin, APAP is the most common cause of acute liver failure (ALF) in the United States; in fact, over 50% of all ALF cases are a direct result of APAP overuse.1 Despite this knowledge, the incidence of hepatotoxicity is on the rise. One group reported that cases of ALF attributed to acetaminophen overuse increased from 28% in 1998 to 52% in 2004.2 Risk factors for APAP-attributed hepatotoxicity include: the concomitant use of multiple APAP-containing products, age greater than 40 years, concomitant drug use (e.g. anticonvulsants such as phenobarbital, isoniazid, and warfarin, etc.), chronic alcohol ingestion (i.e. three or more drinks per day), and serious liver conditions such as acute viral hepatitis.3

APAP overuse has also been linked to renal failure, although the mechanisms are less clear. One study reported that a maximum daily dosage of more than 4 grams per day increased the risk of kidney damage by approximately 4 times compared to nonusers.4 Other toxicities associated with APAP use include serious skin reactions such as Stevens - Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can occur with first-time use or at any point during which APAP is being taken. On August 1, 2013, the FDA issued an announcement informing the public of these rare but serious skin reactions.

APAP Overuse

The concomitant use of multiple APAP-containing products is the primary cause of unintentional overuse. Reports indicate that 38% of patients with unintentional overdose of APAP were taking two different preparations simultaneously.5 Many of the top selling prescription combination analgesics, such as Vicodin® (APAP and hydrocodone) and Percocet® (APAP and oxycodone), contain APAP. Compounding the problem is the fact that APAP can be found in many OTC cold, allergy, pain, and sleep medications as well, which for the unsuspecting consumer, can lead to therapeutic redundancy and unintentional overuse.

Also, APAP overuse due to overprescribing continues to be a widespread problem. It is of paramount importance that the mindful clinician continues to limit the maximum daily dose of APAP to no more than 4 grams per day when prescribing and recommending APAP-containing products. Adherence to the FDA-approved maximum daily dose of APAP not only prevents potential toxicities, but may also alleviate significant legal risk in the event of an APAP-related adverse event.

Regulatory Developments

Regulatory developments and partnerships have been implemented in order to combat overprescribing. The Centers for Medicare and Medicaid Services (CMS) has established the Overutilization Monitoring System (OMS), a program that assists Part D sponsors in preventing the over-dispensing of prescription medications, including those containing APAP. CMS provides Part D sponsors with reports that identify beneficiaries with potential overutilization issues. In turn, Part D sponsors are required to investigate identified overutilization issues and outreach with prescribers regarding daily doses of APAP exceeding 4 grams. Plan sponsors are also working with network pharmacies through adjudication software, pharmacy education, etc. to perform pharmaceutical care to prevent inappropriate dispensing.

Additionally, in January 2011, the FDA issued a regulation regarding prescription combination products which limits the maximum amount of APAP in each tablet to 325 milligrams, in hopes of mitigating the overuse potential of APAP. The deadline for manufacturers to comply was January 2014. New labeling requirements have been implemented as well: all prescription drug products containing APAP must now include a black box warning regarding liver injury and the risk of serious skin reactions.

Recommendations

APAP overuse is a threat to patient safety. The concomitant use of APAP-containing products and overprescribing are contributing factors to overuse. Healthcare professionals have formed valuable partnerships in order to combat this issue. Additionally, you, as a clinician invested in optimal outcomes, can put into practice the following recommendations:

  1. Consider the long-term safety and efficacy of treatment when recommending or prescribing an APAP-containing medication.
  2. Assess patients for risk factors associated with APAP-attributed hepatotoxicity.
  3. Ask patients about all OTC products they are currently taking and confirm that the potential maximum daily amount of APAP, in conjunction with prescription medications, does not exceed 4 grams.
  4. Consider limiting treatment to the use of a sole APAP-containing medication.
  5. Review other options when managing acute and chronic pain, such as NSAIDS and APAP-free opioids.
  6. Advise patients to read the labels of OTC products to avoid taking multiple APAP-containing products.
  7. Inform patients of the signs and symptoms of adverse effects and toxicities associated with APAP overuse.
  8. Consult and direct patients to the Acetaminophen Awareness Coalition website for a list of APAP-containing products: http://www.knowyourdose.org .
  9. Report all adverse events to the FDA MedWatch program: http://www.fda.gov/Safety/MedWatch .

This information is not intended to replace your clinical judgment. Only you, in direct consultation with your patient, may determine if drug therapy benefits outweigh the potential risk. If a change is warranted, please advise your patient directly.

References

  1. Ostapowicz G, Fontana RJ, Schiødt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002;137(12):947-54.
  2. Lee WM. Acetaminophen toxicity: changing perceptions on a social/medical issue. Hepatology. 2007;46(4):966-70.
  3. Chun LJ, Tong MJ, Busuttil RW, Hiatt JR. Acetaminophen hepatotoxicity and acute liver failure. J Clin Gastroenterol. 2009;43(4):342-9.
  4. Kelkar M, Cleves MA, Foster HR, Hogan WR, James LP, Martin BC. Acute and chronic acetaminophen use and renal disease: a case-control study using pharmacy and medical claims. J Manag Care Pharm. 2012;18(3):234-46.
  5. Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42(6):1364-72.
  6. FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure. January 13, 2011. Available at: http://www.fda.gov/drugs/drugsafety/ucm239821.htm . Accessed November 21, 2013.

Antipsychotic Use in the Elderly

CMS National Partnership to Improve Dementia Care in Nursing Homes:

In 2012, the Centers for Medicare and Medicaid Services (CMS) developed the CMS National Partnership to Improve Dementia Care in Nursing homes. One of the goals set by this program was to achieve a 15% reduction in antipsychotic use within nursing homes. The creation of this goal was due in part to the Office of the Inspector General (OIG-HHS) for the U.S. Department of Health and Human Services report released in 2011, which indicated that in nursing homes:

  1. 88% of atypical antipsychotic claims were for patients with dementia, an indication with a black box warning.
  2. 83% of atypical antipsychotic claims were for non-FDA labeled indications (off-label indications).
  3. 50.2% of atypical antipsychotic claims were improperly billed to Medicare due to the fact that Medicare does not cover off label indications, which are not supported by drug compendia.
  4. 22% of atypical antipsychotic drugs claims were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes due to excessive dose, duration, inadequate monitoring or continuation despite adverse effects.4

A separate OIG report released in 2012 indicated that long term care facilities were not in compliance with federal requirements for the documentation of patient assessments, decision making, care plan development, and care plan implementation in patients receiving antipsychotics.3

Risks of Antipsychotic Use in the Elderly:

The FDA Black Box Warning for both conventional and atypical antipsychotics outlines the increased risk of mortality in elderly patients treated for dementia-related psychosis. The FDA warning is based on a review of 17 placebo-controlled trials studying 5,377 elderly patients with dementia-related behavioral disorders. The studies reported a 1.6 to 1.7 times greater increase in death with the use of atypical antipsychotics compared with the placebo group. Additionally, two large epidemiologic studies with a combined population of 37,241 elderly patients found that the increased risk of death was similar between conventional and atypical antipsychotics.5

In addition to risks for increased mortality, antipsychotic use in the elderly is associated with an elevated risk of cerebrovascular events, adverse metabolic effects, extrapyramidal symptoms, falls, cognitive worsening, cardiac arrhythmia, and pneumonia. Conventional antipsychotics may pose an even greater safety risk.1,2

Gradual Dose Reductions:

Gradual dose reductions are an important tool in minimizing adverse effects of antipsychotic medications. Tapering of antipsychotics allows medical providers to determine the medication's true efficacy, the need to continue the medication, and optimal dosing. In nursing homes, gradual dose reductions should be conducted annually unless clinically contraindicated.1,2

Prescribing of Antipsychotics to the Elderly:

According to CMS, antipsychotics prescribed for the elderly in nursing homes should generally be used only in the treatment of the following conditions as identified by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition:

  • Delusional disorder
  • Hiccups (not induced by other medications)
  • Huntington disease
  • Mood disorders (e.g. bipolar disorder)
  • Medical illnesses with psychotic symptoms (e.g., neoplastic disease or delirium)
  • Nausea and vomiting associated with cancer or chemotherapy
  • Psychosis (in the absence of dementia)
  • Schizo-affective disorder
  • Schizophrenia
  • Schizophreniform disorder
  • Treatment related psychosis or mania (e.g., high-dose steroids)
  • Tourette's Disorder

Antipsychotics may occasionally be considered for behavioral or psychological symptoms of dementia (BPSD) if:

  • The behavioral symptoms present a danger to the resident or others
  • AND one or both of the following:
    • The symptoms are identified as being due to mania or psychosis (such as: auditory, visual, or other hallucinations; delusions, paranoia or grandiosity); OR
    • Behavioral interventions have been attempted and included in the plan of care, except in an emergency. 1,2

Summary:

Neuropsychiatric symptoms such as agitation and delusions occur commonly in elderly patients with dementia and often cause significant distress. Data on treatment efficacy are strongest for atypical antipsychotics, but these agents must be used with great caution. An antipsychotic trial is warranted when non-pharmacological intervention is unsuccessful and neuropsychiatric symptoms or associated behaviors cause severe distress or pose a significant safety risk. Risks, benefits, and alternatives should be discussed with the patient and surrogate decision maker, with an opportunity given to ask questions. Dosages should be the lowest necessary, and metabolic parameters should be regularly monitored. Face-to-face visits are important to monitor response, tolerance, and the need for continued treatment. For patients in whom neuropsychiatric symptoms have been much improved or have been in remission for 3-6 months, a discontinuation trial should be considered. Through careful selection of appropriate patients for treatment, education of patients and caregivers, and close monitoring, safety risks can be minimized.

References:

  1. Department of Health and Human Services. Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 – Quality of Care and F329 – Unnecessary Drugs.
  2. Department of Health and Human Services. CMS Manual System Pub. 100-07 State Operations Provider Certification. http:/www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/r22soma.pdf  PDF Document
  3. Department of Health and Human Services- Office of the Inspector General. Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs. July 2012. OEI-07-08-00151. https://oig.hhs.gov/oei/reports/oei-07-08-00151.asp  
  4. Department of Health and Human Services- Office of the Inspector General. Medicare Atypical Antipsychotic Drug Claims to Elderly Nursing Home Residents. May 2011. OEI-07-08-00150. https://oig.hhs.gov/oei/reports/oei-07-08-00150.asp 
  5. U.S. Food and Drug Administration. Information for Healthcare Professionals: Conventional Antipsychotics. August, 15, 2013.