John Macoviak MD, Retire Heart Surgeon On A Heart Valve Procedure

Should payment for a successful and fast-growing revolutionary heart valve procedure be limited by Medicare to only certain large hospitals? Smaller facilities, many in rural areas hours away from the large ones that do the procedure, are also fighting to be included in the payment for Transcatheter Aortic Valve Replacement (TAVR).

Half of the approximate 250,000 Americans estimated every year to have developed severe aortic valve stenosis, a narrowing of the valve that regulates the blood flow from the heart to the largest artery, die within two years.

In open-heart surgery, the chest is cracked open, but TAVR threads a catheter which is tipped with the synthetic replacement valve through a blood vessel and to the heart. The new valve is implanted, the old valve is pushed aside but remains, and the new valve takes over the work.

Over 135,000 mostly elderly patients have undergone the procedure, and the mortality rate in the hospitals has fallen by 1.5 percent, which is two-thirds. Patients can leave the hospital in two or three days and return to daily activities much quicker than with open-heart surgery, which usually requires a six-week recovery.
In 2011, Medicare agreed to pay hospitals $45,000 for each TAVR case, and that excluded the doctor’s fee. However, payment was limited to hospitals that serve only large numbers of cardiac patients. Private insurers typically follow the Medicare standards.

Hospitals make just a small profit because the device costs over $30,000, but the hospitals benefit because a TAVR patient usually needs other cardiac tests and services, and offering TAVR helps the recruitment and retention of top specialists.

A campaign by smaller hospitals and the medical device industry argues that the TAVR technique’s current limitations discriminate against patients in rural areas and minorities and forces them to undergo the significantly more invasive and riskier open-heart surgery or not get a new valve. Hospitals that have the TAVR franchise are fighting new competitors and say that programs that don’t do enough procedures would also not provide high-quality care.

On July 25, 2018, in Baltimore, a Medicare advisory committee heard both sides. A majority supported the continued use of volume requirements. The Centers for Medicare & Medicaid Services is expected to decide later this year whether to change its TAVR patient volume minimum. Meanwhile, industry analysts say that within the next year the Food and Drug Administration (FDA) is likely to approve TAVR for all patients who need a new aortic valve.