I recently returned from the 18th Annual Compounders on Capitol Hill Meeting for the International Academy of Compounding Pharmacists. During the event, I was able to gain valuable insight into topics at the forefront of compounding pharmacies. One lecture in particular pertained to recent changes in USP standards as they relate to both sterile and non-sterile compounded preparations. For background purposes, the USP was developed in 1820 by a group of physicians. At that time, physicians were frustrated by the lack of standardization of compounded preparations. Prescriptions varied depending on the area specified – meaning the name of a preparation in one area may have been under a different name in another. This lack of consistency in the preparation of formulations presented a need for uniformity; therefore, the physicians involved devised a text to standardize pharmaceutical preparations.
The Preface of the USP as of 1820 was:
It is the object of a Pharmacopeia to select from among substances which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage. It should likewise distinguish those articles by convenient and definite names, such as may prevent trouble or uncertainty in the intercourse of physicians and apothecaries.
New updates of USP 795 for non-sterile formulations were very enlightening, and the USP 797 Sterile Compounding guidelines are currently in review with changes to be published within a year. This is of particular focus for Hartley Medical as we shall be actively involved with adapting to and exceeding the new guidelines as they are developed.
Another topic of interest presented, and one that Hartley Medical has been following, pertains to reimbursement for drugs from the Centers of Medicaid and Medicare Services (CMS) – which is very important as it relates to billing for pharmaceutical and physician services. The speaker’s primary purpose was to direct individuals to the importance of billing properly and accurately to avoid headaches and wastage. She specifically defined Fraud Waste and Abuse (FWA) according to CMS and gave examples of inappropriate billing practices and the ramifications associated with such billings. What I took away from this lecture was that if you are billing CMS inappropriately, the cascade effect results in a loss of the privilege to bill CMS, and then ultimately private insurance and Medicaid/Medicare altogether. She stressed the importance of verifying that you are billing according to reimbursement guidelines as failure to do so can result in subsequent damage to your practice.
I feel intellectually rewarded after attending a meeting of such great breadth. The information presented benefits my practice and patients, as well as the individuals and organizations I service.
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