Monthly Archives: July 2015

Golden Living Centers to Make High-Dose Flu Vaccine Available

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The influenza season of 2014-2015 was notable for a poor antigenic match between the vaccine and the flu strain in the US, as well as a higher proportion of elderly individuals being hospitalized than in previous years[i]. This year, several healthcare organizations have switched over to a high-dose influenza vaccine for patients 65 and over.

The high-dose influenza vaccine has been available since 2009, but until recently there wasn’t clinical evidence to support the theoretical advantage over vaccines with the standard-dose. High-dose trivalent vaccine is a vaccine which contains increased antigen in order to better stimulate an immune response in elderly persons.

In a trial of almost 32,000 patients at least 65 years of age in 126 centers in the United States and Canada, patients were randomized to receive either high-dose trivalent influenza vaccine or traditional dose trivalent vaccine[ii]. The study encompassed two consecutive flu seasons, one in which had low influenza activity, and where there was a moderate-to-good match between the vaccine antigens and the strain and one season in which there was high activity and in which there was a poor match between vaccine antigens and the strain affecting the community.

Laboratory confirmed influenza was studied as the clinical endpoint. Ultimately, 1.9% of patients in the Standard Dose and 1.4% of patients in the High-dose group developed laboratory confirmed influenza. This represented a 24.2% improvement relative in protection in the High-dose Group versus Standard Dose. When narrowed to similar strains (antigenic near match) this improvement in efficacy was about 35.4%. There was no significant difference in adverse effects of the vaccine.

Given the notable improvement in performance of high-dose vaccine in the 65 and older population relative to standard dose, at Golden Living we have decided to make high-dose vaccine available in order to better protect our patients. Standard-dose vaccine will also still be available.

We will continue our close surveillance during flu season for outbreaks, and continue to stress adherence to our infection control practices. Please encourage your patients and Golden Living employees to get vaccinated for influenza. The flu vaccine is not 100% effective, but will significantly decrease risk of contracting the flu, and if an immunized person gets the flu, severity and duration of illness as well as risk of complication is significantly diminished.

If you have any questions about the flu vaccine for this year, please feel free to contact me at michael.yao@goldenliving.com or Golden Living Director of Pharmacy Steve Hord at steven.hord@goldenliving.com.

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[i] Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015 Morbidity and Mortality Weekly Report (MMWR), Jan 16, 2015 / 64(01);10-15

[ii] DiazGranados, CA et al, Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults, N Engl J Med Aug 14, 2014;371:635-45.

Mark Your Calendar! August 26 at 7 p.m. Eastern

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Mark your calendars!  Dr. Mary Evans Presents: A “How To” Guide for decreasing Inappropriate use of antipsychotic meds – Wednesday, August 26 at 7 p.m. Eastern Time.

In Town Hall discussions, several Golden Living Medical Directors have stated that while they agree that CMS and the medical literature which recommend decreasing antipsychotic prescribing in their Living Centers, they could use some guidance on how to best do this in a patient currently receiving this medication. Golden Living Regional Medical Director Dr. Mary Evans will lead a practical Webex discussion on how to do this in a safe and effective manner.  Among other issues regarding antipsychotic prescribing, gradual dosage reduction will be discussed, and case studies will be utilized to trigger interactive dialogue.  More details will be provided soon.

The OIG and You

OFFICE OF INSPECTOR GENERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES SEALThe Office of the Inspector General (OIG) recently reached settlements with 12 individual physicians who entered into questionable medical directorship and office staff arrangements. OIG alleged that the compensation paid to these doctors under the medical directorship arrangements constituted “improper remuneration under the anti-kickback statute.” They alleged that the payments took into account the physicians’ referrals and did not reflect fair market value for the services performed. They also stated that the physicians did not actually provide the services called for under the agreements.

OIG also alleged that some of the doctors had arrangements where another healthcare entity assumed responsibility for the salaries of the physicians’ front office staff. This also was considered improper remuneration to the physicians because they would have had to pay these salaries otherwise. OIG determined that the physicians were an integral part of the scheme and subject to liability under the Civil Monetary Penalties Law.

What does this mean for you?

The OIG is paying increasing attention to physician contract arrangements.  Golden Living seeks at all times to be compliant with both the letter and intent of the law. It is also necessary to have documentation in order to protect all parties involved.  As a Medical Director, you are paid for administrative work for Golden Living.  As part of your contractual arrangement, there is a timesheet which is required on a monthly basis to document that you have been doing Medical Director activities.  These activities are diverse and include activities such as attending QAPI meetings, reviewing medication errors, calling into Golden Living Medical Director Town Hall Meetings, meeting with the State Surveyors and providing advice on employee health.  Activities not included are time spent seeing your own patients, for which you must bill payers separately.

In order for you to be protected, it is necessary to keep documentation of these activities.  Golden Living Centers has a form which makes it relatively easy for you to check off and categorize what you’ve done in your role as Medical Director role for the month.  Having filled many of these out over the years,  this takes less than a minute or two to do, even if you put in extra detail.  If you need a copy of this form, please ask your Executive Director or send an e-mail request to Reene Dux, Head of Medical Services, at maureen.dux@goldenliving.com.  Once completed, it should be given to your Executive Director.

Off-Label Prescribing

Off Label PrescriptionsAs you know, off- label prescribing is a common activity in medical practice.  Judicious use of off-label prescribing can be of benefit to patients, allowing usage of medications which have evidence-based efficacy in treatment of conditions for which the manufacturer did not secure FDA approval.

The FDA agrees with this concept, stating “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”  Accordingly, most court decisions uphold the prescriber’s right to use medications for indications other than those approved by the FDA.

Off-label prescribing can have its downside as well.  Some medications, while expensive, do not have the sort of evidence-basis for its use that others have.  There have been well known cases where drugs developed a reputation for benefit in off-label uses that were undeserved and where controlled trials showed no benefit over placebo.  Even worse, some manufactures have been judged guilty of marketing off-label usages, which is expressly prohibited.

The increasingly high costs of health care continue to cause health care payers to search for ways to trim expenses.  Health insurance companies closely scrutinize drugs that are used off-label. Although Medicare recently changed its rules to allow for wider coverage of off-label uses of cancer drugs, insurers do not always pay for unapproved or unproven products. Many will cite off- label use as a reason for non-coverage of an otherwise formulary included medication.

At Golden Living, we have noted increased Prior Authorization documentation requirements.  For example, insurers will often reject lidocaine transdermal patches when used for anything other than the FDA indications of post-herpetic neuralgia,  diabetic neuralgia, cancer pain or burn pain.  Other examples include atypical antipsychotics when prescribed at dosages or frequencies not indicated on the approved labeling and use of a medication for a longer period of time than indicated including proton pump inhibitors and sedative hypnotics.

If you run into difficulties getting authorizations for off-label usage of a medication, consider whether or not you feel that the benefit of the medication is worth the cost. Perhaps there is even a drug in the same class with an approved indication for what your patient needs.  Your consultant pharmacist should be able to assist you with these choices, and may have an understanding of what documentation is necessary in order to get approval if you feel there is no reasonable alternative.  If you have further questions about this topic that your consultant pharmacist cannot answer, please feel free to contact Eric Stratford at eric.stratford@goldenliving.com , Steve Hord at steven.hord@goldenliving.com or myself.

Note About Antipsychotics

One off-label use that is drawing requests for prior authorization with increasing frequency is the use of atypical antipsychotics to treat behavioral symptoms of dementia. At Golden Living, we urge you to thoughtfully reconsider usage of atypical antipsychotics in this instance because of limited evidence of efficacy combined with known increases in mortality risk. Your consultant pharmacist and behavior management team should be able to help you with nonpharmacologic approaches as well as assist in attempts at gradual dosage reduction when clinically appropriate. as well as devise specific strategies to observe and modify patient behavioral outcomes. For more information about antipsychotic prescribing, see this First Monday Article by Dr. Evans.