Menopause Mondays: Compounding Pharmacies
Do you take medication for your perimenopause and menopause symptoms? Women have different journeys through perimenopuase and menopause that often require customized combinations of treatments. You may be receiving your medications from a compounding pharmacy. On January 1, 2012, a new policy called D.0 (dee-point-zero) went into effect that changes the way compounded medications are reimbursed, forcing pharmacies to reject some insurance claims. Christine Givant, RPh, and Deb Hubers from La Vita Compounding Pharmacy in San Diego tell us what we should know about compounding pharmacies and D.0.
Q: What are compounding pharmacies? How do they differ from traditional pharmacies?
A: Compounding pharmacies specialize in the preparation of medications by mixing raw ingredients to formulate a medication that is custom made exclusively for a patient based on a prescription from a physician. Traditional pharmacies dispense commercial medications manufactured by a pharmaceutical company. Compounding pharmacies can dispense commercial medications as well as compound medications. All pharmacies (compounding and traditional) are regulated by the State Board of Pharmacies in their respective states. No pharmacy is regulated by the FDA. Reputable compounding pharmacies use ingredients that are sourced from an FDA-approved chemical house.
Q: Why would women entering perimenopause and menopause use a compounding pharmacy vs. a national chain pharmacy?
A: Each woman is unique and has specific health considerations as she ages – we are not a “one-size-fits-all” society. Therefore, a woman’s treatment must be personalized to address her individual health requirements. Physicians use compounding pharmacies to customize a woman’s prescription to meet her unique health needs. Although there are commercially available bio-identical hormones, they are only available in limited dosages and forms. If your physician’s protocol requires a different dosage form, she/he will prescribe a compounded medication formulated exclusively for you. There are other ingredients that may need to be included and/or combined in a treatment regime that are only available from a compounding pharmacy. For example, Estriol is a bio-identical hormone that is not available commercially.
Q: What is PCAB and what does it mean if a pharmacy has its PCAB accreditation?
A: There is a significant difference between pharmacies that compound and a true compounding pharmacy. Remember, you are putting this medication on your body and/or ingesting it orally. It’s very important to make sure the pharmacy compounding your medication knows what they are doing and formulating in an environment that is conducive to producing a quality outcome.
PCAB stands for The Pharmacy Compounding Accreditation Board. If a pharmacy has its PCAB accreditation, that means it is legitimate. It adheres to the “Principles of Compounding,” its product’s potency is ensured through formal testing, its operating procedures are regulated and approved, its facilities exceed inspection standards, its lab design and equipment is of highest quality and safety, its personnel is trained properly, it buys from FDA-approved chemical houses, and its physicians prescribe the highest-quality compounds with confidence. We can’t think of anything more important in selecting a compounding pharmacy. For more information visit pcab.info.
Q: What are some other tools to help us locate a reputable compounding pharmacy?
A: The following are some good questions to ask the pharmacy:
Do they have a sterile clean room?
Do they send out formulations to a third party for potency and stability testing?
What training does their staff have in compounding?
How many years have they been compounding medications?
What equipment do they use to compound your medication?
Do they mill their creams?
Are they certified or accredited by their national organization?
Ask them if you can make a site visit or ask them to show you where they compound the medications. Patients can learn a significant amount about how their medication is prepared by visiting the pharmacy. If you can’t make a site visit, ask for pictures of the lab.
Ask yourself… do you want to take a medication that is not prepared in a clean laboratory without the proper equipment by trained staff?
Q: What is D.0 & why has it come into effect?
A: The federal government has worked with the pharmacy and insurance industry to implement a new set of reimbursement regulations called D.0 (dee-point-zero). D.0 is part of the Health Insurance Portability and Accountability Act (HIPAA) (American Medical Association). The goal of the program is to improve the efficiency and effectiveness of the health care system by creating a more consistent and standard method of processing pharmacy claims. Effective January 1, 2012, all insurance carriers must reimburse medications according to the new standard. Some carriers have asked for an extension to prepare for the changes and have until April 1, 2012 to comply.
Q: How are patients affected by this new HIPAA insurance billing standard?
A: There have been significant changes in the way compounded medications are being reimbursed among the various insurance carriers because of D.0. Many of these changes have created extra administrative burdens on all pharmacies, forcing some pharmacies to stop taking insurance for compounded medications. Not all of the insurance companies are implementing all of the elements of the D.0 standards fully at this time. These inconsistencies are creating payment discrepancies, forcing claims to be denied and/or putting certain claims in dispute with managed care organizations. Industry leaders are still working out some of the issues related to reimbursements for compounded medications. The good news is that some insurance carriers are fully compliant and patients are not seeing any difference in their reimbursement of compounded medications. Unfortunately, there are a large number of carriers that are still in the process of implementing D.0 for compounded medications and patients may see their out-of-pocket amount increase because of D.0.
If patients are having their claims denied, no longer covered and/or are seeing a substantial increase in their co-pays, the best thing a patient can do is inform their benefits manager at their employer so they can contact their insurance carrier to correct the situation. Also, joining patient advocacy groups like Patients and Professionals for Customized Care (P2C2) are extremely effective in informing governmental officials on the issues patients are having related to their individualized health care needs. Membership is free and thousands of members have successfully worked with legislators to ensure physicians can continue to have the right to prescribe compounds and that you continue to have access to the personalized medicine you need and deserve.
Every woman requires a different approach to feeling her best in perimenopause and menopause. Thank you, Chris and Deb, for helping us to understand the facts about compounding pharmacies and the new challenges created by D.0.
Christine Givant, RPh & Deb Hubers are Co-Founders of La Vita Compounding Pharmacy. Learn more at LaVitaRx.com.