President Obama made this ringing declaration when he was promoting the Affordable Care Act: "I will ensure that no government bureaucrat gets between you and the care that you need."
Now comes Trigeminal Neuralgia, known in medical neurological parlance as a particularly vicious type of headache, so severe that some victims contemplate suicide. All the same there is a treatment for this disease that is remarkably successful in most cases. The usual treatment is with a medicine known as tegretol. Today's story is about a star-crossed patient who was unable to tolerate tegretol and what happened to her when Gubbamint Bureaucrats got their hands on her case.
Initially, the patient was overjoyed. Her debilitating headaches evaporated under treatment with tegretol. Imagine, then, her consternation when she developed an allergic reaction to the medication. The allergic reaction included skin rash and an alarming development of abnormal hepatic function tests. There was no choice but to discontinue the tegretol.
Doctor X replaced the tegretol with gabapentin which also worked. However, there were physiological non-allergenic side effects, e.g., dizziness, impaired balance, and sedation. So now the second successful medication had to be replaced. This step was taken with an extended release form of gabapentin known as Gralise. Medicare approved the use of Gralise but after a year another application to continue use of this medicine had to be submitted to the Center for Medicare and Medicaid. The Center for Medicare and Medicaid then rejected the proposed use of Gralise even though it had now been the patient's chief headache prevention medication for over one year.
The reason was that FDA had approved Gralise for Herpetic Neuralgia only, not for Trigeminal Neuralgia. On this flimsy basis, Medicare in one fell swoop allowed the misery of intractable headache to invade this patient's life once again. Use of the medication for a different type of pain was called "off label" and subjected to unthinking automatic rejection.
Doctor X appealed at the state level. In California the law allows continuation of care under such circumstances, e.g, AB 974 (Gallegos), a managed care reform bill that requires managed care plans to continuously provide prescription drugs. Unfortunately, this state legislation can be overruled by federal law that precludes "off label" prescribing. The next step was appeal to the Medicare Appeals and Grievance coordinator who pointed out that Medicare only allows medications to be covered on Part D when the FDA has approved the medication for that specific use -- in this case FDA had approved the medication for one form of neuralgia but not for another. Next, Doctor X sought a hearing before a judge in the Office of Medicare Hearings and Appeals. The case was made that FDA approved the medication for one form of neuralgia so it was reasonable in this case, especially since the medication had worked well for this patient for over one year, to allow renewal.
Unfortunately, logic and science lost out to rule-making and semantics. The court ruled that the patient could not have the Gralise covered under Medicare. The judge's final letter of denial was issued on 2/18/16. The question arises as to what extent the federal system is responsible for denial of care when an adverse event occurs as a result of governmental ineptitude.
In 1999 the Oregon Board of Medical Examiners disciplined a doctor for insufficiently treating pain. In discussing an analogous situation in California in 1979, Dr. Wm. Steinmith wrote that "a variety of official police bureaus -- under the rubric of protecting the public from professional abuse and abusers -- are rapidly destroying the professional foundations of humane and rational medical care." This author's opinion is that the Center for Medicare and Medicaid acted arbitrarily and wrongly in this case.
Previously, The Weinmann Report, www.politicsofhealthcare.com, 3/18/14, and workcompcentral, 3/26/14, showed how an insurance company's Utilization Review company declined authorization of analgesic medication.
This writer's finding is that the newest epidemic is the denial of medications by one or another form of Utilization Review at both state and federal levels. Physicians will take the blame while patients get the shaft. We need to hold the presidential podiatry to the fire on this issue lest all of us in due course get burned by the "government bureaucrats" from whom President Obama promised to protect us.
"Utilization Review: Hypocrisy in Velvet Gloves," workcompcentral, 2014-03-26 and The Weinmann Report, www.politicsofhealthcare.com, 2014-03-18;
The Hill Newspaper, Washington, DC, 9/16/09, "What Obama should've said about health reform," by Robert L. Weinmann, MD;
Headache Quarterly, V. VII. #4, 1996, "Predatory Policies in Health Care: Headache Patients as 'Marks,' " by Robert L. Weinmann, MD;
New York Times, National, 09/04/99, "Oregon Board Disciplines Doctor for Not Treating Patients' Pain;"
San Francisco Medicine, "Professional Judgment," July 1979, by William Steinsmith, MD.