By Erika Hanson for BioLawToday.org
This year will no doubt bring new innovations in medicine and technology. Many of these innovations have been in the works for a while, though, but insurance coverage of the procedures has been limited. One innovation that has been in the works is the transcatheter aortic valve replacement (TAVR), a procedure that replaces a defective aortic heart valve without opening the chest cavity. Instead of opening the chest cavity, the doctors will access the heart through a blood vessel in the patient’s leg or through a small incision in the chest. Prior to TAVR, patients with a defective aortic heart valve had to undergo open-heart surgery. In open-heart surgery, the breastbone of a patient’s chest is cut through and the patient is connected to a heart-lung bypass machine, which moves blood away from the heart, and surgeons operate on the heart. After the surgery, a patient will spend a couple of nights in the intensive care unit (ICU) and then be moved to a regular hospital room for anywhere from three to seven days. Id. The TAVR procedure allows the patient to go home the same day as the procedure. The recovery after TAVR is also much faster than the recovery after open-heart surgery. Id. Most importantly for some patients, TAVR can be performed on patients who were at too high of a risk for the open-heart procedure to be performed.
TAVR has been widely successful, but despite this wide success, not all hospitals offer TAVR. Medicare coverage for TAVR has influenced the lack of TAVR accessibility. Medicare coverage applies to forms of care that are “reasonable and necessary” for treating or diagnosing a medical illness or injury. A national coverage determination may be made through an evidence based process. Id. A national coverage determination was issued for TAVR. To perform TAVR hospitals were required to have certain volume requirements.
To receive Medicare reimbursement for TAVR, however, hospitals are required to have certain volume requirements. For a hospital to begin doing TAVR and receive Medicare reimbursement, the hospital must do more than 50 aortic valve replacements a year and have greater than 10 high-risk patients. Id. A hospital must also have done over 1000 catheterizations per year. Id. Then to continue a TAVR program that’s covered by Medicare, a hospital must do more than 20 aortic valve replacements a year or more than 40 every two years, and more than 1000 catheterizations. Furthermore, hospitals must have the site where TAVR is being done meet these volume requirements, so a hospital with multiple locations cannot combine the two locations to meet the volume requirements.
These volume requirements were put in place because procedure volume was a good predicator of success with TAVR. Some doctors, though, say that there is “little evidence [that] hospitals that perform more TAVRs have lower mortality rates.” Id. Moreover when Medicare coverage requirements for TAVR were put in place, TAVR was still a fairly new procedure. Now that TAVR is being performed more often, Medicare volume requirements may need to be reevaluated to reflect the progress of TAVR.
In 2018, three physicians formally requested that Medicare coverage requirements for TAVR should remove the volume requirements. The Center for Medicare & Medicaid Services (CMS) that establishes Medicare coverage for TAVR said that by the Summer of 2019 they expect to update coverage for TAVR. It will be interesting to see if the new Medicare requirements remove the TAVR volume requirements. Hopefully, the changes to Medicare requirements for TAVR help promote access to TAVR for patients, as TAVR is a ground-breaking innovation for cardiology and innovations building upon or expanding TAVR use will continue.
Erika is a third-year law student at S.J. Quinney College of Law at the University of Utah. Prior to law school, Erika attained a master’s degree in Cell and Molecular Biology and worked as a research scientist at a biotech startup, Stratos Genomics, in Seattle, WA. She came to law school to help scientists and other inventors protect their inventions. After completing law school, she plans to practice patent law. Outside of law school Erika enjoys all the outdoor activities Utah has to offer, especially skiing. Erika also remains an Oregon duck fan, go DUCKS! Her fellowship is sponsored by the University of Utah’s Center for Medical Innovation and she helps student inventors protect their patent rights by preparing preliminary patent filings.