Vertebral Augmentation: Navigating the Unknown to Ensure Payment

Physicians urged to monitor all upcoming developments regarding this new issue.

The debate over percutaneous vertebral augmentation is continuing in 2020, with the release of a new local coverage determination (LCD) from Noridian – a Medicare Administrative Contractor (MAC) – and the release of a proposed LCD by another MAC, Novitas. In order to successfully navigate the situation and get paid what they are owed, physicians must closely monitor all of the upcoming developments.

Understanding the Context behind the Controversy
This procedure is usually used for elderly patients who have vertebral compression fractures that cause back pain and have not responded to conservative measures; it involves injecting a cement-like substance, with or without balloon expansion, to stabilize the vertebrae and reduce pain. For several years, percutaneous vertebral augmentation was an accepted and commonly done procedure. Then in 2009, a study published in the New England Journal of Medicine showed no benefit for either short- or long-term pain control. This trial, in contrast to previous studies of the procedure, was a blind, randomized, controlled trial, wherein the control patients experienced a simulation of the procedure, but no cement was actually injected.

In 2018, these findings were reproduced in a sham-controlled, double-blind randomized study published in the British Medical Journal, providing further ammunition to those supporting payors’ non-coverage of the procedure. A year later, Noridian acknowledged that the science is not settled on the effectiveness of vertebral augmentation, in their response to comments made to their proposed LCD, noting “the longstanding (and recently heightened) controversial nature of vertebral augmentation.” The Centers for Medicare & Medicaid Services (CMS) has conducted technology assessments and listed the procedure as a topic for a future national coverage determination in the past, but has not yet developed one – leaving MACs the responsibility to develop the LCDs.

To that end, in the last week of 2019, Notivas released a proposed LCD for public review and comment. The proposed LCD shares many features with Noridian’s final LCD, released in November 2019, suggesting that the MACs are taking to heart the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) 2014 recommendation that CMS work to increase consistency among LCDs from different MACs.

The Proposed Local Coverage Determination: Features to Watch
Considering the controversy over the effectiveness of this procedure – and the likelihood that auditors will use this controversy as a reason to audit – a few features of the LCDs warrant discussion:

First, the patient’s pain must be quantified using either the Numeric Rating Scale or Visual Analog Scale pain score, and the scores must correlate to the requirements specified. It will not be sufficient for physicians to quantify the pain as moderate or severe.

Second, the decision to proceed with vertebral augmentation must be made by consensus of a multidisciplinary team that includes the referring physician, the physician performing the procedure, a radiologist, and a neurologist, which may also create difficulty for hospitals. This requirement is based on a 2017 guideline from the Cardiovascular and Interventional Radiological Society of Europe. While this recommendation may make sense for Europe, it may not be supported by the standard of care in the United States. In most hospitals, the radiologist interprets the imaging and documents the presence of the compression fracture and the characteristics that support that the fracture is recent. Unless that radiologist is an interventional radiologist, it is unlikely that he or she would interact directly with the patient to determine the duration or degree of pain, nor perform a physical examination. Without a history and physical examination, the radiologist cannot provide an opinion on whether vertebral augmentation is indicated.

Additionally, there is no medical necessity for a neurology consultation and evaluation unless other issues warrant it. It is clearly within the realm of the skills of the neurosurgeon, orthopedic spine surgeon, or interventional pain management physician to perform a neurologic examination to eliminate other causes of the back pain. A basic tenet of Medicare coverage for any service is that the service must be medically necessary; requesting a neurology consultation to provide an opinion on the medical necessity of a procedure to be performed by another physician does not meet that standard.

The Road Ahead
Awareness of and compliance with the requirements of the LCD published by a facility’s MAC is imperative to ensure payment. And while LCDs are not binding on an administrative law judge (ALJ), an overturn may take several years to occur if a denial is issued and appealed. If a facility is not within the jurisdiction of a MAC that has issued an LCD, coverage decisions are left to the discretion of the medical review staff at the MAC. It is possible that a MAC’s medical review staff would refer to the LCDs published by other MACs. This suggests that following the published LCDs would be a wise course of action.

Unless the medical literature resolves the uncertainty of the effectiveness of vertebral augmentation, or new technology renders it obsolete, this is certainly an issue to watch.

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