We rely on the FDA to protect public health “by assuring the safety, efficacy, and security” of medical drugs and devices. The FDA takes its marching orders from Congress via the legislative process. One such law is the Compounding Quality Act of 2013, passed in response to a series of fatal infections due to improper compounding pharmacy processes. While such oversight is important and well meaning, the unintended consequences may be profound.
In my medical specialty of retina surgery, compounded and off-label Avastin is used in the treatment of macular degeneration, diabetic retinopathy, and other retinal conditions. At a cost of 40 times less than the FDA approved options, using compounded Avastin instead of the on-label expensive alternatives could save Medicare $3 billion per year. Studies have shown the lower cost Avastin is equivalent to the much more expensive Lucentis in treating macular degeneration. Many physicians will try Avastin as the first line of treatment in their patients and continue using it if it is working well.
As Avastin is being used “off-label” in a much smaller dose than used for its approved use in cancer treatment, it must be divided into extremely small doses suitable for injection into an eye. This is done by a compounding pharmacy. Most patients receive injections every four to six weeks for many years, with many physicians deciding at the time of the eye exam whether or not to give an injection. Most patients are elderly and/or visually impaired, meaning that a friend or family member brings them to their eye appointment.
Back to the FDA, which recently issued guidance in response to the new, compounding law. Specifically they “will require a patient-specific prescription for all drugs compounded.” While this may allow easier tracking of the rare cases when drugs are contaminated, it won’t alter the actual compounding process and won’t reduce the chance of contamination.
But once the retina surgeon examines the patient and determines that they need an injection, instead of using a preordered syringe from their inventory, they will instead have to send a prescription to the compounding pharmacy and have the patient return on a separate day for their injection. For a patient receiving monthly injections, this translates to 24 office visits rather than 12 each year. Depending on insurance, there may be a copayment for each visit. Not to mention the friend or family member doubling their driving duties and the physician further loading their already busy patient schedules. Imagine going to the family doctor for a flu shot and after a quick exam, having to return a week later for the shot after the doctor writes a prescription for it rather than simply pulling a vial of flu vaccine from the refrigerator and giving the injection.
The simple alternative for the surgeon is to abandon any intention of being a good steward of societal and patient monies by simply using the FDA approved, but far more expensive, drugs. This avoids the hassle of writing several hundred injection prescriptions each month and making patients return a week later for each injection. Good financial stewardship of government money loses appeal when the government complicates the physician’s business processes by such mandates. And when the government threatens physicians with a 30 percent cut in reimbursement via the SGR cuts, why should physicians jump through hoops to save Medicare a few dollars?
Aside from costing Medicare additional billions by using the more expensive drugs, what about patient copayments? Medicare pays 80 percent of the drug cost, leaving patients with a $400 copayment on a $2000 per-dose drug. Elderly patients have a choice between going broke with the expensive drug or doubling their office appointments to receive the inexpensive drug.
The other threat against physicians taking the path of least resistance by using the expensive approved drugs is the negative publicity from the recently released Medicare physician payment data. The flaws in this data dump are legion, but pale in comparison to having your photo in the local newspaper captioned as, “Million-dollar Medicare doctors.” The millions actually accrue to the pharmaceutical companies, not the physicians, but the damage is done.
So physicians are stuck between a rock and a hard place. The new FDA regulations discourage the use of less expensive but efficacious medications while the Medicare payment data dump discourages the use of the more expensive, but FDA approved drugs. Physicians left in the middle of this bureaucratic tug of war between government agencies are placed in a no win situation. No wonder articles such as, “How Being a Doctor Became the Most Miserable Profession” are becoming increasingly popular.
Dr. Joondeph is a retina surgeon at Colorado Retina Associates and serves on the faculty of Rocky Vista University School of Medicine.