Health Care Innovation Frustrated by Federal Regulation in Action
- by Jeff Voigt
During this past month, a client and I have been involved in a rather heated discussion with Medicare in an effort to persuade it to do the right and fair thing. The client’s technology, a powered bone marrow biopsy system, is used to a major degree in the physician office setting, a care setting that is less cost intensive than the hospital setting. Currently, however, the product is not used in the physician office setting because of the coding of this product and because of its increased costs relative to manual methods. The simple reason is that Medicare’s payment for the physician office setting does not adequately cover the biopsy system’s costs. Physicians will not use it, as they would lose money.
The powered bone marrow biopsy product has demonstrated its clinical utility. It has improved outcomes on lower pain for patients and allowed for significantly larger sample biopsy size. Bone marrow biopsies are an uncomfortable procedure and can be painful to the patient. Reducing a patient’s pain is a good thing, and obtaining a larger sample size enables a clinician to more accurately diagnose a patient’s condition.
It would seem natural for Medicare to want to ensure that its beneficiaries have access to this product in the doctor’s office as it meets Medicare’s mission of providing access to high-quality care and improved outcomes at lower costs.
However, this product has been denied a code and associated reimbursement because it was determined that Medicare could not find a “programmatic need,” and that it was not its responsibility to do so. Medicare stated it was the American Medical Association’s (AMA) responsibility. The technology is now stuck in “reimbursement limbo” as the AMA’s representatives will not do anything with it.
We recently presented to Medicare to request a reconsideration of their decision that this was not their responsibility. We, unfortunately, will not hear back for five months.
This situation is not unique. AdvaMed, the Washington-based trade association that leads industry’s effort to advance medical technology, has voiced the same concern that Medicare’s process to evaluate these types of code applications is not transparent. Medicare provides no process for appealing a “no code” decision and no detailed rationales for its decisions, according to AdvaMed.
Access to better care that is cost-effective should be the medical community’s responsibility (i.e., everyone’s responsibility). It is the triple aim of medicine.