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08/28/2014 Allen Jacobs, DPM
In-Office Compounding
In-office compounding has been around a long time. There is nothing wrong with compounding selected pharmaceutical ingredients in your office for patient treatment. The issue your question raises is not about Stark Law. It should be about medical liability, kick-back laws, ethics, and not jeopardizing your in-network medical status with payers. 1. Liability is a major issue. When a pharmacist dispenses a drug to a patient, they hold 100% all patient liability for safety around allergies, drug to drug interactions, contraindications and side effect profile. The pain creams sound pretty simple but most of them have 5-8 active ingredients (including CII and CIII drugs) and the bases contain over 25-30 ingredients.
Although the systemic exposure is less than oral, there is still exposure and it varies depending on skin type (elderly and children). When there is an issue with the medication you dispensed, you are the one the patient calls for immediate solution. Due to this, you will also need to have a 24 hour hot line to field non-911 issues. The companies that are doing this shell game are passing all liability on to you so be sure to increase your liability coverage with the money you gained from playing pharmacist. This is not worth my time.
2. Price gouging: The company is charging insurance companies ridiculous amounts of money and passing a fraction of that revenue to you. Just remember that when a patient’s insurance gets billed thousands for the pain cream, you will be the one the patient comes running to. It usually presents itself as a patient carrying an EOB yelling, “you charged my insurance $3,500 for that cream.”
Be sure to ask the company to disclose how much money they bill the insurance company (per gram) for each prescription you will be compounding. There are only a few PCAB/CQI accredited pharmacies that do this the right way. Stick with them and you will not look bad.
3. Co-Pays and Deductibles: Be sure to ask the company to disclose how they handle collecting co- pays and deductibles. What do they do for a patient who has a $100 copay and the patient cannot afford it. Most companies are waiving co- pay which is strictly against the insurance policies. You don’t want to be associated with this practice. Even though you are not influence by the pharmacy benefit managers (i.e. ESI/MEDCO), you are influenced by their clients, the payers (BC/BC and others). They are the ultimate payers of all drugs. I do not think it is worth it to risk your “in-network” status for something like this.
4. Kick-back Warning: Be aware of the state and federal laws. This may not be a STARK violation but it could be a kick-back violation. How do you know that patient you dispensed to and received remuneration for was not a post office worker with insurance paid for by the state? What about Obamacare insurance? This is federally backed and the cards do not make mention of the fact.
Filtering out federal and state programs is not easy anymore. Who has time to worry about this? The other pharmacies do. They will be happy to report things like this and even if everything is operating by the book. I sure see no benefit having auditors in my office for things outside my scope of expertise. You asked……It is not worth your time. Stay focused on what you know. Allen Jacobs, DPM, St. Louis, MO, allenthepod@sbcglobal.net
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