Migraine, DESI Medications, and Medicare
At the end of last year when I went to refill Midrin, the only Migraine abortive medication that works for me, I received quite a surprise. The new health insurance plan I switched to, a Medicare advantage plan, did not cover it. I made this switch due to an unbelievable increase in the monthly premium. Yes, I researched my medications before switching plans, and Midrin appeared on my new plan’s drug formulary. But Medicare can and does make changes and no longer covers Midrin. As such, my Medicare advantage plan does not cover any drugs that Medicare does not cover. Why, you may ask? Let me explain.
Midrin and a host of other medications are on the Food and Drug Administration’s (FDA) Drug Efficacy and Study Implementation list, which is commonly referred to as the DESI list. This list contains medications that the FDA doesn’t feel are effective or safe. Medicare does not cover medications on this list; therefore many Medicare advantage plans do not cover them either. This is because they follow Medicare guidelines.
Drugs on the DESI list include those that were involved in the new drug application (NDA) process - safety portion only - from 1938 - 1962 and drugs that were the same, related or similar to said drugs. These drugs are not “grandfathered” nor are generally recognized as safe and effective (GRAS/E). Manufacturers with medications on this list have had the opportunity to apply for a NDA or an abbreviated new drug application (ANDA) to address the FDA’s requirements. Other medications that Medicare does not cover because of the DESI list include:
- Alcortin gel - aloe hydrocortisone, used to treat red, itchy skin;
- Amidrine, Duradrin, Epidrin, Apap/Isometheptene/Dichlphen, isometheptene/dichloralphenazone/acetaminopheIsometh/D-Chloralphenz/Apap, Midrin, Migquin, Miratine capsules - aborts Migraines;
- Isoxsuprine 10 mg tablets - a vasodilating drug;
- EEMT HS tablet, Estratest tablets, Estratest, Essian tablet, Estrogen-Methyltestosterone cream, Syntest D. S. - estrogen;
- HC Pramoxine cream 2.5%, HC Pramoxine rectal cream 2.5 % mg, Analpram HC 2.5% cream, Pramosone 1% cream, Hemorrhoidal HC 25 mg suppositories, hydrocortisone AC 25 mg suppositories, Proctosert HC 30 mg suppositories, Rectasol HC 25 mg suppositories - these are hydrocortisones used to treat certain rectal conditions;
- Clidinium/CDP capsules used to treat upset stomach;
- Belladonna/Phenobarbital tablets - anticholinergic barbiturate combinations used to treat irritable bowel syndrome and other conditions;
- Bellaspas tablets - an anticholinergic/barbiturate/ergot combination used to treat menopause symptoms and other conditions;
- trimethobenzamide 200 mg suppositories - brand name Tigan, Ticon, Benzacot used to treat nausea and vomiting.
Medications on the DESI list are not the only ones Medicare does not pay for:
- medication for anorexia, weight loss or weight gain medications;
- medications that assist in fertility;
- medications for cosmetic reasons;
- cold or cough medications;
- prescription strength minerals or vitamins;
- barbiturates unless they are ONLY used to treat epilepsy, cancer and unremitting mental illness;
- medications for sexual problems;
- any medications that are not FDA approved;
- DESI medications;
- devices such as diaphragms;
- medical supplies like testing strips for diabetics (I don’t understand this at all);
- sterile water for injection;
- line flush solutions;
- medications that are covered under Part A or Part B of Medicare.
Here’s the thing, Midrin and many of these medications have been around for many years and been effective. You may have been keeping up to date with the information Teri has written regarding Midrin and its issues. To read more see Midrin Equivalent Migraine Medication Available.
As I mentioned earlier, plenty of people use Midrin as it’s the ONLY thing that aborts their Migraine. And while the baby boomer, Medicare and Migraine population continue to grow, there will an immense amount of people with limited options to abort a Migraine. Yes, we’ll still be able to get it as long as it’s produced, or have a compounding pharmacy make it for us but at what cost? I spoke with my pharmacist this morning, and she reported I will be able to refill generic Midrin (from the manufacturer Macoven) for $290 for 120 capsules. That’s more than twice my car payment More importantly is there anything I can do about it?
There is an appeal process for Medicare health plans according to the Medicare website. It seems to be a grueling process that starts with:
The EOC, or “Evidence of Coverage” which explains your coverage. You have the right to request that the drug should be covered. If the plan doesn’t cover the drug, ask the plan or doctor if there are any special coverage rules.
Then get a written explanation, which is called a coverage determination, from the plan.
Next you can ask for an exception if you and the doctor feel the drug needed is not on your plan’s formulary.
Ask for an exception if you and your doctor feel the coverage rule, for example prior authorization, needs to be waived.
Ask your plan for an exception if you or your doctor feel you are paying too much for a higher tier (more costly) medication because you and your doctor agree you are not able to use the lower tier (less costly) medication for the same illness.
You or doctor needs to talk with the plan asking for a coverage determination or exception. If the pharmacy can’t fill a prescription, they will give you a notice explaining how to get in touch with your Medicare drug plan to make the request. If you are not shown this explanation, ask to see it, it is your right.
You or the doctor can make a request by phone or in writing, as long as you haven’t received drug benefits yet. On the other hand if you or doctor is requesting to be reimbursed for medications already purchased, this has to be done in writing.
You must call your plan, write to them or complete and send a “Model Coverage Determination Request” form asking your plan for a coverage determination or exception. The plan has 72 hours to notify you of their decision after they’ve received a standard request.
There is also an expedited or fast request. Your request will be expedited if you have not received the prescription and the plan determines or your doctor tells your plan that your life and health are in danger by waiting. The plan has 24 hours to notify you of the decision after receiving the expedited request.
A letter of medical necessity must be sent to the plan by the doctor explaining why an exception is necessary.
Your Medicare plan will send you their decision, in the mail.
If you disagree with their decision, you may appeal it.
That process is long, in-depth and will probably be very time consuming. If however you are denied at that point, there are five other “levels” you can use to further your appeal, but that is for another post altogether! At least let me share these leves with you:
- Level 1. Redetermination from your plan.
- Level 2. Review by an Independent Review Entity (IRE).
- Level 3. Hearing before an Administrative Law Judge (ALJ).
- Level 4. Review by the Medicare Appeals Council (Appeals Council).
- Level 5. Judicial review by a federal district court.
I spoke with my Medicare advantage plan and they too have an appeal process. The appeal packet has been mailed out to me and I’m anxiously waiting to see if it will be anything like the Medicare site implies. The last time I dealt with an insurance company for an appeal process, I won, but it was a total fiasco. The paper work was endless, the phones calls were redundant and it was very time consuming. It feels as if the process is so long and painful the insurance company hopes you drop it all together. Could that be? What are your thoughts on Medicare, DESI medications, and Migraine?
Autor, Deborah, Esq. “The Unapproved Universe.” Center for Drug Evaluation and Research, Office of Compliance. January 9, 2007. https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm118338.pdf
Medicare Health Plan Appeals. “How do you appeal if you have Medicare prescription coverage?” Medicare.gov. Last accessed February 24, 2013.
Prioity Health Medicare Plans. “Drugs never covered by Medicare.” Last updated October 1, 2012.
Thanks for reading,
© The HealthCentral Network, 2013 Last Updated February 26, 2013.
Nancy wrote for HealthCentral as a patient expert for Migraine.