In the past, the only way to repair a damaged aortic valve was open-heart surgery. In 2011, the FDA approved a medical device to repair the heart using a catheter in the leg artery called the Sapien 3. The cost of the new valve is the same as cracking the chest, but has lower risks and is an easier procedure to perform. Medicare fears that more elderly patients will want their hearts repaired with this new technology, so strict coverage rules have been set in place.
For a patient to qualify for the new procedure, Medicare requires two cardiac surgeons to certify the patient cannot handle open-heart repair. A cardiothoracic surgeon and interventional cardiologist must also be present in the operating room during the procedure. This is very costly and limits procedures to large academic medical centers. The FDA has labeled the valves to require these restrictions.
Many more patients could benefit from the noninvasive valve repairs. Studies show that the replacement valves are superior to risky open-heart surgery, including mortality and risk of stroke. Patients who have less risk of death aren’t eligible for the new devices under current Medicare rules, so many are still opting for invasive surgery.
Aortic valve devices and their skilled usage have improved since Medicare imposed their initial restrictions. It will take well over six months for the FDA to update the product labels and more for Medicare to change its payment rules for the new procedure.
As the government continues to regulate medicine and ration care, medicine cannot evolve with scientific advancement. Progress comes when physicians are free to practice medicine based on science and not coverage rules. Medical decisions should be left to patients and doctors, offering good prices and timely medical care.
Gottlieb, Scott. “Warning: Medicare May Be Bad for Your Heart.” Opinion. The Wall Street Journal, 11 Apr 2016. Web. 19 Apr 2016.