Monday, December 30, 2013

The Government's Response: Notes, Part 4, "Non-FDA-Approved Drugs"

     One of the government's allegations against me is that I billed Medicare for non-FDA-approved medications and devices.
     The  medications in question, used in both of my clinics were FDA-approved:  Reclast, Boniva, Synvisc and Orthovisc.  The devices were Paraguard and Mirena IUDs, made and packaged by the original manufacturers, also FDA-approved.
     Reclast and Boniva are IV medications for osteoporosis, and Synvisc and Orthovisc are intra-articular injections for degenerative knee arthritis.  My clinics had excellent nursing staff who were experts at IV placement and never, in ten years, had complications from IV placement--no infections, no phlebitis, no bleeding problems.  I did the joint injections (with a few exceptions, after I taught a physician assistant to do them), for which patients were grateful, because long-acting corticosteroid injections have been shown, over the past forty years, to be safe and effective at treating arthritic joint pain and stiffness, and Synvisc and Orthovisc (made from rooster-combs!) replace synovial fluid, lost through aging, in the knees.
     These four medicines cost more to purchase than the reimbursement from Medicare, the prime insurance coverage for most patients who need osteoporosis and arthritis treatments, covers.  We couldn't even break even on the cost when we compared prices from our usual suppliers:  Henry Schein and Merck.   The IUDs cost more to purchase than any insurance company would pay for insertion of an IUD--the same insurance companies that paid for pregnancy and delivery of infants born to mothers who didn't want a child or were taking pregnancy-compromising medicine or illicit drugs.
     I asked my nursing staff to compare prices at as many different pharmaceutical suppliers as seemed reasonable and to find the best price for these products;  then, I could make a decision about whether we could afford to lose money by offering them.  Maybe we'd find a supplier with a price that wouldn't put us in the red every time we treated a patient.
     Northwest Pharmacy had a price slightly below the Medicare reimbursement for those four medicines.  The nursing staff filled out our standard purchase order form to get my approval to order them so we could treat the many patients who requested these medicines for osteoporosis and arthritis, or who wanted IUDs.  Northwest Pharmacy turned out to be a Canadian pharmacy:  the FBI agents who raided my clinic told me and said they were illegal.
     "Did you know these IUDs were made in Thailand?" Special Agent Robert Murphy accused.
     "Everything we use in the clinic is made somewhere outside the United States," I said.  This exam table is probably from Asia."  I lifted an instrument out of the sink.  "This alligator forceps came fem Germany.  That watch you're wearing was probably made in China.  So were your shoes, I'll bet."
      The products were made by U.S.-owned companies (whose factories are outside America);  they were FDA-approved, bought legitimately by this well-established Canadian (it turns out) pharmacy;  sold in vast numbers to American physicians and clinics;  unopened, unaltered, and stamped as approved by U.S. Customs and Border Protection patrols;  then, strangely, become "illegal."  It makes no sense, but that's the law, and "I knew or should have known," therefore could be convicted of a felony for "importing" and using them.
     The six medicines and products under question weren't made in someone's garage or sold out the trunk of an old Cadillac in a back
     The United States government has decided that it won't prosecute people for purchasing medicines from Canada, India, Mexico or anywhere, if they're "for personal use."  It won't prosecute citizens, physicians or clinics for small quantities.  The government accepts, therefore, that the products are safe.  But an FDA-approved medicine that crosses the American border and then returns, remains "illegal," nonetheless, and the government reserves the right to convict a doctor of a felony-offense for using it.
     If you stroll through any American drugstore you'll see that most over-the-counter drugs are made in other countries:  the Prilosec package, for instance, says, "Made in India."
     The retail price of Reclast varies greatly.  A 5 mg vial is the once-yearly treatment for osteoporosis, is administered IV and takes ten or fifteen.  The best price we could procure, before finding Northwest Pharmacy, was close to $1,400 for 5 mg.  Medicare "allowed" $224.75 per mg, or $1,123.75 per 5 mg dose, but only paid 80% of that, or $899.00--the patient's secondary insurance would have to pay the other 20%.  (If the secondary insurance is Medicaid, the doctor has to write off the 20%.)  Therefore, we would lose $276.25 per dose if we administered Reclast to Medicare/secondary insurance patients, and $501.00 per dose for Medicare/Medicaid patients.  Not good for business--but I knew that Reclast was the optimal treatment for many of my osteoporosis patients, and I wanted them to have it.
     Northwest Pharmacy was a life-saver for all of us, since its price of $1,135.18 for 5 mg allowed us to administer Reclast without losing money.  We could bill for the IV-administration (a separate, nominal fee), and make a profit of $11.43 per dose.
     The same set of circumstances conditioned my clinic use of Boniva, Synvisc, Orthovisc, Paraguard and Mirena.  Boniva cost the clinic $481.29 per dose;  Medicare reimbursement was $363.94 plus a secondary insurance or self-pay amount of $90.98 if a patient didn't have Medicaid), causing us to lose $26.37 per dose for Medicare/secondary patients, and $117.35 per dose for Medicare/Medicaid patients.  No wonder so few doctors administer these invaluable medications in their clinics.
     Even if I had registered that these supplies had been routed through Canada, it wouldn't have seemed significant, given the multinational (outsourced) production of all American pharmaceuticals.  (Don't we have a trade-agreement with Canada?)  If it's a felony to purchase once-FDA-approved medicines (which, crossing the border into Canada, mysteriously become non-FDA-approved)-- medicines that allow doctors to do their job of treating and curing conditions that cause disability, falls and death, or incur joint pain, or prevent unwanted pregnancies--if it's a felony for a doctor to purchase medicines at a price below insurance reimbursement, in order to stay in business, then there's something wrong with our justice system.
     But we already know there's something wrong with the justice system, don't we?

     Addendum:  Here are a few items from an internet search on Reclast, for your perusal.  Look at the charges for Reclast, by other physicians.  Are doctors confused about billing issues, and reasonable charges, or what? 

Ruthie Says:

I had an infusion of Reclast at an infusion center in June 2010 and my Medicare HMO received a bill for over $7000 for which they paid $5800 claiming that was the average price that Medicare allows. My local pharmacy as well as an online quote was $1000 at the time. Why is there such a vast difference between a hospital charge and the retail market price? 

cost of Reclast Infusion with Insurance

I just got my bill from my recent reclast infusion.
My insurance company was billed $15663.75 for this procedure.
Thank goodness, I only have to pay a $50 deductable
Has anyone else had this experience?
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From the AgingWell website:

"Cost could be seen as an obstacle for patients considering Prolia as a treatment option. While generic Fosamax costs roughly $100 to $200 per year and brand-name bisphosphonates slightly less than $1,000 per year, Prolia will cost about $1,650 per year plus the cost associated with an office visit. Prolia is also more expensive than Reclast, which costs $1,100 for a yearly dose. "

Given the large attention given to a few rare thigh fractures associated with Reclast, and the fact that infusion centers and the doctors who prescribe the drug are prime targets for med/mal lawsuits, I wonder how much of the billing is CYA insurance? But that cost is outrageous. Our infusion center does charge about $250 over our cost for the drug for having registered nurses prepare the drug for injection using sterile technique, starting the IV, the cost of the IV tubing and sterile saline, syringes, needles, and bio-hazard disposal costs for the used IV and needles, alcohol, bandages etc, and monitoring vital signs pre-, during, and post infusion to look for signs of actue phase reaction, and make follow-up phone calls on all patients the next several days and documentation of all of this as required by federal and state regulations. But adding an extra $17,000? I would ask that you call the billing department and demand a justification for why such a high overhead that they never get from people with health insurance plans that reduce the cost.
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