Off-label Use
I am more confused by FDA labeling now than ever before. More importantly, the vagaries of FDA labeling are beginning to have an even greater impact on the interventional cardiologist than ever before. Recently, our local Blue Cross has enacted a policy to automatically deny PFO closure (a common phenomenon across the country). They justify their stance by pointing out that closure of a PFO requires an off-label use of a device (unless the patient is receiving a designated PFO occluder device as part of a research study). Their seemingly shocked response as to why they are denying these cases is almost comical — reminiscent of the famous line in the movie Casablanca (“I am shocked, shocked to discover there is gambling in this institution” as Claude Rains collects his gambling winnings). Of course they are aware this is an off-label use of ASD or VSD devices, but their pretense suggests that they would never consider it appropriate to authorize or support anything off-label.
This stance by Blue Cross has gotten me thinking about both sides of this issue. Obviously, it is natural for me to want greater freedoms in caring for my patients, and I am saddened that I am handcuffed in providing the care that the patient, the patient’s other caregivers, and I have deemed preferable for that individual. I am particularly frustrated when there are extenuating circumstances making the alternative treatment options even less satisfactory than typical. These include such things as patient inability to take prolonged antithrombotic therapy, need for protection during upcoming surgery, or PFO closure being done to treat platypnea-orthodeoxia, as a few examples.
It is vexing that Blue Cross is willing to pay for the more morbid surgical closure of PFO’s. Yesterday I visited my patient in the ICU who had his PFO closed surgically the day before, because the insurance company would cover the open heart surgery, along with the multiple day hospital stay, but not the outpatient percutaneous closure procedure. It seems arbitrary that device-type therapies are being selectively denied, even though percutaneous PFO closure has been far more studied than surgical closure of PFO’s.
The use of “off-label” as a justification for insurance denial is obviously related to a perceived ability to cut costs, and is somewhat egregious since it is only used selectively. Insurance companies pay for “off-label” use of stents all the time – there would be an incredible hue and cry if they did not cover stents for such indications as acute myocardial infarction, use of more than one stent at a time, use in chronic total occlusions, use in multivessel disease, etc., yet all of those indications are listed in the “package insert” as having “safety and effectiveness that have not been established”, which is widely recognized as being the language representing “off-label”, even though technically that is not the case. Actually, the Directions for Use indicate specifically that “The (drug-eluting) Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter of greater than or equal to 2.25 to less than or equal to 3.50 mm.” It is true that Washington State sponsored insurance companies tried to abolish payment for “off-label” uses of drug-eluting stents, before eventually deciding to cover only vessels treated with stents less than or equal to 3.0 mm, or longer than 15 mm. So, for Washington State supported insurance programs, FDA labeling is not the arbiter of coverage, but a negotiated compromise which ended up deviating from FDA labeling. Thus, we have different insurance programs selectively refusing to cover certain procedures because they are off-label, and others who don’t even cover all labeled indications, while covering some that are technically off-label. As I said, the issue of FDA labeling is becoming even more confusing. I am reminded that this self-righteous stance by Blue Cross is not an accurate reflection of the FDA or our federal government’s stance on physician’s ability to prescribe off-label therapy. This has been tested both in Congress and the court of law, and it has been agreed upon that physicians have the right and responsibility to prescribe off-label therapy if they believe it is in the best interest to their patients. The FDA itself has reaffirmed their support for off-label use on numerous occasions. Certainly it would have been malpractice not to prescribe clopidogrel over the last decade or so to patients receiving coronary stents, but that is an off-label use of that therapy (which is also covered by insurance, by the way).
The flip side of the coin is the question as to why should insurance pay for therapies which have not been been scrutinized by our federal body tasked with recognizing effective therapies, the FDA. There is a legitimacy to this question, but it is chilling to think that the medical community will become increasingly hostage to the arbitrary manner the insurance companies are going about this restriction of coverage. Obviously as far as devices to close PFO’s goes, this is prompted by the costs of the devices, and the overwhelming prevalence of PFO’s in the population. The potential for abuse is very high, as physicians may be closing PFO’s for marginal (or imaginary) reasons. Thus, it is not surprising that some insurance companies are choosing this as a battleground. However, it is my suspicion that this is a bell-weather –– that there will be an increasing ratcheting down of coverage for off-label therapies.
As I mentioned in an earlier blog, the insurance companies are not going to sit idly by while the upcoming health care overhaul occurs. They will find ways to ration care, and I think that this self-righteous attitude toward off-label therapy coverage is a clue as to how they are going to go about the rationing of care. Is this something we can combat, to protect our ability to care for our patients? I would invite suggestions how to address this likely juggernaut of practice restraints.
Steven L. Goldberg, MD is the Director of the Cardiac Catheterization Laboratory at the University of Washington Medical Center in Seattle, where he is a Clinical Associate Professor of Medicine. He also serves as the Chief Clinical Officer for Cardiac Dimensions, Inc., a small biotech company in Kirkland, Washington.
