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Editorial: Insurance Company Discrimination, Revisited-Time for a Class Action?
Insurance companies continue to discriminate against their patients who need and physicians who prescribe compounded medications. One of the latest is from Prime Therapeutics, the PBM for Blue Cross/Blue Shield of Florida. A letter to beneficiaries who have received compounded prescriptions was sent in late August informing them that effective 1 October 2010, no compound will be covered as part of the prescription benefit if that finished product was prepared using APIs (bulk ingredients). As one beneficiary letter states: "prescription compounding powders are not approved drugs by the US Food and Drug Administration (FDA). If you have a compounded prescription containing the above powder(s), please consult your doctor or pharmacist to discuss drug alternatives that are approved by the FDA and covered by your prescription plan." (From the IACP e-Link; 9/9/10).
All compounded medications are "unapproved" by the FDA. Combining two FDA-approved products into a single compounded preparation forms an "unapproved" product; the insurance companies do pay for "unapproved products." This decision by Prime Therapeutics is based upon incorrect information�let's look at the facts:
Insurance companies "do" pay for:
- Intravenous admixtures compounded in a hospital for a patient
- TPN solutions compounded in a hospital for a patient
- In-syringe admixtures compounded in a hospital for a patient
- Cancer cocktails compounded for a patient
- Flavored antibiotic oral liquids (this is compounding) for a patient
- Pediatric formulations compounded for children when there is not an oral liquid available
- Pre-1938 drugs are unapproved drugs, including:
Acetaminophen, Codeine Phosphate and Caffeine Capsules and Tablets; Amobarbital Sodium Capsules; Amyl Nitrate Inhalant; Chloral Hydrate Capsules, Syrup and Suppositories; Codeine Phosphate Injection, Oral Solution and Tablets; Codeine Sulfate Tablets; Digitoxin Tablets; Digoxin Elixir and Tablets; Ephedrine Sulfate Capsules and Injection; Ergonovine Maleate Injection and Tablets; Ergotamine Tartrate Tablets; Hydrocodone Bitartrate Tablets; Hydrocodone Bitartrate, Aspirin and Caffeine Tablets; Hydromorphone Hydrochloride Suppositories; Morphine Sulfate Oral Solution and Tablets; Nitrolycerin SL Tablets; Opium Tincture; Oxycodone Tablets; Oxycodone Hydrochloride Oral Solution; Paregoric; Phenazopyridine Hydrochloride Tablets; Phenobarbital Capsules, Elixir and Tablets; Phenobarbital Sodium Injection; Pilocarpine Hydrochloride Ophthalmic Solution; Potassium Bicarbonate Effervescent Tablets for Oral Solution; Potassium Chloride Oral Solution; Potassium Gluconate Elixir and Tablets; Potassium Iodide Oral Solution; Salsalate Capsules; Sodium Fluoride Oral Solution and Tablets
While many pharmacists do not accept insurance but do assist the patient in applying for reimbursement, this can impact whether or not the patients will receive reimbursement.
It's time the insurance companies stopped discriminating, misleading, and "defrauding" their patients by denying them reimbursement under misleading conditions. Either cover ALL compounded medications as listed above, or cover NONE of the compounded medications listed above! Why would a company want to deny a patient and physician the medication specific for a patient to get them back on their feet faster than going to some alternative (which in many cases has already been tried) and require the patient to continue taking the medication longer (and costing the insurance company more money)?
We have already discussed the multitude of problems of using finished commercial products in compounding rather than APIs (USP quality bulk substances). Compounding with commercial products (where large variations are often allowed) sometimes results in compounded medications that do not meet the USP standards of 90% to 100% of the active ingredients, and this is uncontrollable by the compounding pharmacist; the pharmacist is forced to violate USP compounding standards. It's time the insurance companies woke up!
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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CMS Backing Down on AMP Rule
The Centers for Medicare & Medicaid Services is moving to withdraw provisions of an Average Manufacturer Price (AMP)-based Medicaid reimbursement formula that would have led to dispensing of generic drugs at below acquisition cost in many instances. Implementation of those provisions has been blocked by an injunction won by NCPA and the NACDS. The proposed rule calls for the withdrawal of existing provisions that define AMP, that determine the calculation of federal upper limits, and that define "multiple source drug."
(NCPA e-News Weekly; September 7, 2010)
FDA Cracking Down on Misleading Ads
Misleading ads are a target of the FDA as pharmaceutical companies become more aggressive and creative with their marketing tactics. The agency issued 45 warning letters in the first eight months of the year for marketing violations; this compares with 21 in all of 2008.
http://www.reuters.com/article/idUSTRE6821PN20100903
FDA Backtracks and Returns Drug to Market
The Food and Drug Administration announced a couple of weeks ago that it would remove the drug midodrine from the market because the drug's maker never confirmed that the medicine, which was approved in 1996 under an abbreviated process, actually worked against dizziness and fainting. However, about 100,000 patients who take midodrine for conditions many say would otherwise be disabling, flooded the agency with complaints. The FDA officials have announced that they had backtracked and would continue to allow midodrine to be sold.
Dr. Joshua Sharfstein, principal deputy commissioner stated, "�in this case, it does not make sense to pull access to the drug while we get better data." Dr. Janet Woodcock, director of the agency's drug center agreed. "Patients are out there thinking doom is about to fall, and they can't go about their normal business," she said.
Cracking down on the industry, sometimes means stranding desperate patients. And now that Congress has given the FDA greater powers to insist on better information about life-saving medicines, such disputes may become more common. (Editor's Note: Maybe they should reconsider their stand on "estriol" and "domperidone" as thousands of patients were, and are, adversely affected!)
http://www.nytimes.com/2010/09/04/health/policy/04fda.html?_r=1&ref=health
CDC: Prescription Drug Use Continues to Increase
In the U.S., spending for prescription drugs was $234.1 billion in 2008, which was more than double what was spent in 1999. As new drugs are introduced and new uses for old drugs are found, more patients can have improved health and quality of life with the appropriate use of prescription drugs. (Editor's Note: If "total compounded" prescriptions, including sterile, nonsterile, hospital, outpatient, ambulatory, etc., is about 10%, then compounding is now a $23 billion dollar a year industry.)
http://pharmalive.com/news/index.cfm?articleID=726947&categoryid=9&newsletter=1
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