ACCEL | The Ultimate Dilemma: The Disconnect Between Guidelines, Appropriate Use Criteria, and Reimbursement

An editorial in JACC recently addressed "The Ultimate Dilemma: the Disconnect Between the Guidelines, the Appropriate Use Criteria, and Reimbursement Coverage Decisions."1

Here's the gist of the problem: in 2013, the ACC and seven other organizations published appropriate use criteria (AUC) for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT).2 The criteria were developed to critically review clinical situations that may warrant implantation of an ICD or CRT device.

The writing committee recognized that some of the scenarios deemed "appropriate" or "may be appropriate" were discordant with the clinical requirements of many payers, including the Medicare National Coverage Determination (NCD). To charge Medicare for a procedure that is not covered by the NCD may be construed as fraud despite the recommendations of the professional guidelines.

As Dr. Fogel and colleagues wrote in their JACC viewpoint paper, discordance among the guidelines, the AUC, and the NCD forces physicians to face the difficult dilemma of trying to do the "right thing" for their patients who require an ICD, but recognizing that the "right thing" may not be covered by the payer or insurer. Oops.

According to Fogel et al., contributing to the problem: the last major revision to the NCD was in 2005, meaning it does not address many of the scenarios for ICD primary prevention use determined to be appropriate by the AUC authors. This leaves physicians in the uncomfortable position of knowing that appropriate clinical recommendations may fall outside the scope of the NCD. For patients, physicians, and insurers, these distinctions are critically important because patient-centered care may warrant implantation of a device appropriate for the individual patient's situation that does not fit precisely into a covered NCD. This could lead to denial of payment or investigation for possible abuse or fraud even when the decision was clinically justified.

Help in Any Way

So what should cardiologists and electrophysiologists do? Dr. Fogel and his coauthors strongly encourage the ACC and its various partners who developed the AUC to continue to advocate for legislation that protects physicians who follow the clinical guidelines or the AUC. "Simply put," they wrote, "a physician who follows the standards of his profession in the best interest of the patient should not be subject to civil or criminal penalties."

However, they recognize that physicians and their hospitals have an obligation to understand the current guidelines, be aware of the AUC scenarios, and "practice within the scope of the ICD NCD whenever possible." Conversely, they stated, inappropriate practice outside the guidelines and AUC should not be tolerated.

In other words, "utilizing the right procedure at the right time for the right patient."

In the short term, if an ICD is considered medically appropriate for an individual patient, yet falls outside of the NCD, there are several options. Not perfect options, for sure, but options:

The patient may be a candidate to wear an external defibrillator vest until the requisite time period has passed.

Alternatively, the hospital may choose not to charge for the device or may contact the Medicare fiscal intermediary to prevent any allegation of fraudulent billing or deception.

When there is no good alternative, the patient can be asked to sign an Advanced Beneficiary Notice to acknowledge that the ICD implant may not be covered and he or she may be responsible for the costs of the procedure and the device.

In all cases, when physicians believe that a device is indicated in a situation not covered by the NCD, it is important to use the medical record to clearly document the clinical thought process and rationale for the decision.

Dr. Fogel and colleagues added that physicians also can protect themselves and their health systems from legal action by becoming involved with "teaching coders about what we do, what constitutes a myocardial infarction (not all troponin elevations represent an MI), and clearly stating in the chart when events occur, such as the diagnosis of HF and the initiation of guideline-directed medical therapy."


    Fogel RI, Epstein AE, Mark Estes NA, et al. J Am Coll Cardiol. 2014;63:12-14.
    Russo AM, Stainback RF, Bailey SR, et al. J Am Coll Cardiol. 2013;61:1318-68.

Keywords: Physicians, Deception, Myocardial Infarction, Insurance Carriers, Fraud, Gastrointestinal Stromal Tumors, Medicare, Medical Records, Defibrillators, Implantable, Primary Prevention, Troponin, Cardiac Resynchronization Therapy, Patient-Centered Care

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