It may be time to consider some type of action against third-party payers because of their blatant discriminatory activities. Many refuse to pay for vitally important compounded medications prepared for patients in community pharmacies, using the excuse that they are "not FDA approved." Well, let's look at what they are actually paying for that also falls into the "not FDA approved" category;

1. "Off-label" uses of FDA-approved drugs become "not FDA approved" for the off-label uses for which they are prescribed.
2. Non-FDA approved pre-1938 drugs, including:
   1. Acetaminophen, Codeine Phosphate, and Caffeine Capsules and Tablets
   2. Amobarbital Sodium Capsules
   3. Amyl Nitrate Inhalant
   4. Chloral Hydrate Capsules, Syrup and Suppositories
   5. Codeine Phosphate Injection, Oral Solution, and Tablets
   6. Codeine Sulfate Tablets
   7. Colchicine Injection and Tablets
   8. Digitoxin Tablets
   9. Digoxin Elixir and Tablets
   10. Ephedrine Sulfate Capsules and Injection
   11. Ergonovine Maleate Injection and Tablets
   12. Ergotamine Tartrate Tablets
   13. Estratest and Estratest Half-Strength (HS)
   14. Hydrocodone Bitartrate Tablets
   15. Hydrocodone Bitartrate, Aspirin and Caffeine Tablets
   16. Hydromorphone Hydrochloride Suppositories
   17. Levothyroxine Sodium for Injection
   18. Morphine Sulfate Oral Solution and Tablets
   19. Nitrolycerin Sublingual (SL) Tablets
   20. Opium Tincture
   21. Oxycodone Tablets
   22. Oxycodone Hydrochloride Oral Solution
   23. Paregoric
   24. Phenazopyridine Hydrochloride Tablets
   25. Phenobarbital Capsules, Elixir, and Tablets
   26. Phenobarbital Sodium Injection
   27. Pilocarpine Hydrochloride Ophthalmic Solution
   28. Potassium Bicarbonate Effervescent Tablets for Oral Solution
   29. Potassium Chloride Oral Solution
   30. Potassium Gluconate Elixir and Tablets
   31. Potassium Iodide Oral Solution
   32. Quinine Capsules
   33. Quinine Sulfate Tablets
   34. Salsalate Capsules
   35. Sodium Fluoride Oral Solution and Tablets
   36. Thyroid Tablets
3. Intravenous admixtures compounded in hospitals
4. In-syringe admixtures compounded in hospitals and doctors offices.
5. Total parenteral nutrition solutions compounded in hospitals.

This discriminatory activity must be challenged. It adversely impacts the patient and the pharmacy. It keeps patients from receiving the medications that physicians have determined the patient needs for therapy.

One difficulty is the "mindset" of "AWP" (Average Wholesale Price) and other artificial "costs" of drugs. Third-party payers do not understand pricing for compounded medications and the lack of uniformity in pricing between pharmacies for a variety of legitimate reasons. Consider the plumbing profession; rates differ from plumber to plumber. So, why should the concept of varying rates from compounded medications to compounded medications be a problem for the third-party payers. The one thing they must realize is that the "cost" of a compounded medication is far more than just the cost of the "active ingredient." We'll talk about this later.

In a country where we tend to frown on and work towards eliminating "discrimination," third-party reimbursement is one of the most "blatant" forms of discrimination in health care today. And, I'm sure that there are many other areas of reimbursement that are also problematic.

The actions of third-party payers may even be considered as not only discriminatory and arbitrary but almost on the edge of committing "fraud." Webster's dictionary defines fraud as "deceit, trickery, intentional perversion of truth in order to induce another to part with something of value or to surrender a legal right; an act of deceiving or misrepresenting." I'm sure their may be other legal definitions, but it seems relatively clear to me that third-party payers are not doing what they were originally intended and agreed to do! Also, they are telling some compounders that they DO NOT pay for compounded medications when, in fact, they do!

Discrimination, arbitrariness, fraud, deceit, trickery, perversion, misrepresentation? Sounds like something needs to be done!


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

Use these professional binders to protect and organize your Journal back issues! Each one has a mortar and pestle graphic with the Journal logo. Features include:

• Each binder holds up to two years of IJPC journals
• Provides protection for your journals
• Easy to use
• Professional style

To order, complete and mail or fax the IJPC Binder Order Form from the IJPC Product Page or call 800-757-4572 or 405-330-0094 today.

Only $20 Each (Plus shipping and handling)

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.

APhA-IACP Letter to CMS Regarding Reimbursement of Compounded Inhalation Medications
Senator Chuck Grassley (R-Iowa, Chair of the Senate Finance Committee) sent a letter to the FDA and the Center for Medicare and Medicaid Services (CMS) on July 13 that focused on concerns with compounded inhalation medications. CMS responded to Senator Grassley on August 22 in a letter that indicated that CMS plans to lower reimbursement rates for many compounded medications.

IACP has been working with pharmacy organization allies to explore solutions to the issues raised by Senator Grassley and to ensure that proposed reimbursement solutions are workable for pharmacies and patients. APhA and IACP recently sent a joint letter to CMS regarding this situation. In the letter, IACP and APhA caution CMS not to assume that reimbursement rates for compounded preparations will be significantly lower than current payment rates. The letter emphasizes the numerous costs that are necessary for pharmacies to ensure that they are dispensing a safe and high-quality preparation. Access a copy of the APhA-IACP letter here.

Nail infections are an ongoing problem for patients around the world and all patients do not respond to the same therapy. Take a look at these 61 citations that have been added to CompoundingToday.com's literature search database this week on the subject of cutaneous and nail infections, with an emphasis on topical therapy in treating those nasty nail infections.

Dermatophytosis: The management of fungal infections.
Gupta AK, Ryder JE, Chow M et al. Skinmed 2005; 4(5): 305-310.

Therapies for onychomycosis: A review.
Gupta AK, Tu LQ. Dermatol Clin 2006; 24(3): 375-379.

Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: Results of a double-blind, vehicle-controlled trial.
Lebwohl M, Plott T. Int J Dermatol 2004; 43(Suppl 1): 17-20.

Anti-inflammatory and anti-itch activity of sertaconazole nitrate.
Liebel F, Lyte P, Garay M et al. Arch Dermatol Res 2006; 298(4): 191-199.

Tinea capitis: A treatment update.
Roberts BJ, Friedlander SF. Pediatr Ann 2005; 34(3): 191-200

Are you working with patients and physicians on controlling chronic and/or acute pain? IJPC's Map of the Human Dermatomes can help! This full-color 8 1/2" x 11" laminated map of the human dermatomes is a great educational tool to use when treating pain. Dermatome distribution patterns are relatively consistent from person-to-person, with nerve fibers in certain areas of the skin originating from specific spinal nerves. Using the map helps pinpoint the origin of pain and results in better treatment outcomes.

Summer is over, but the effects of the sun on the skin are not. Moreover, those seeking that year-long tan simply move indoors to the tanning beds, which deliver higher doses of UVA than sunlight. IJPC's September/October 2006 issue features an article titled "Dermatological Effects from Years in the Sun: Compounding Opportunities." This article reviews the structure and function of the skin, the different forms of skin cancer, treatment options for these conditions, and precautions to prevent overexposure to the sun. This article provides the compounding pharmacist: (1) knowledge, (2) information that could be paraphrased into a patient handout, (3) treatment options, and (4) valuable formulations. If you are not a subscriber you can purchase and download the article at www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2442

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

Wireless telephone headsets!
Have a sore neck from placing the phone on your shoulder and tilting your head to "hold it in place?" Get a wireless telephone headset that fits over the head or just over the ear. They can be charged overnight and will work all day. You can answer and talk on your telephone, while walking and working, increasing productivity.