For the last two years the government has been investigating hospitals’ billing for implantable cardioverter defibrillators, or ICDs (not to be confused with ICD-10). The investigation is based on a national coverage determination (NCD) that describes situations in which Medicare will cover ICDs. The federal investigation continues, and to date, there have been no public settlements. Recently, RACs and MACs have been auditing ICD cases, questioning both whether an inpatient admission was necessary and whether the ICD is covered by the Medicare program.
The government’s position is that an ICD is covered by the Medicare program only when the ICD meets the conditions outlined by the NCD. However, that position is not consistent with the Medicare statutes or the program manuals. The Medicare program’s Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (‘NCD Manual’) states that NCDs can describe services that are covered, services that are not covered, or both. However, the language in the NCD must be explicit that it is intended to limit coverage. If the NCD doesn’t state that certain conditions are uncovered, coverage is unaffected by the NCD. The NCD for ICDs describes services for which Medicare provides coverage, but it does not limit Medicare coverage for patients who do not meet the NCD criteria. Therefore, determining Medicare coverage for patients who fall outside the NCD criteria requires a case-by-case analysis of whether a procedure was reasonable and necessary, given the patient’s overall medical condition.
The government has released a proposed resolution model that tacitly acknowledges that there are situations in which a patient does not satisfy the terms of the NCD, but still is eligible to receive an ICD. For example, the proposed resolution allows coverage for patients with syncope when non-cardiac causes have been ruled out, and for patients whose myocardial infarction (MI) or coronary artery bypass graph (CABG) occurred within certain time frames, as long as the patient also needs a pacemaker or cardiac resynchronization therapy. These are both situations in which the NCD does not explicitly indicate that coverage is available. The fact that the government has issued the proposed resolution model is not technically legally binding, but it certainly seems to represent an acknowledgement that it can be medically appropriate to implant an ICD in situations that do not meet the terms of the NCD. Since the Medicare program requires coverage of services that are reasonable and necessary in order to treat a patient’s illness, it is difficult to understand how the government reasonably could assert that only patients fitting the NCD are entitled to coverage.
Because of this, if you are audited by a RAC or MAC for a matter involving an ICD, you should appeal any denial if the physicians involved believe that it was medically appropriate to implant the ICD. The legal case for coverage is incredibly strong. Given the high cost of an ICD and the ease of making the legal argument, challenging ICD denials is well worth the effort, regardless of the NCD, as long as you have strong physician support for the implantation.
There also have been denials indicating that inpatient admission under these circumstances is unnecessary. Some of these letters go so far as to acknowledge that typical medical practice and commonly used review tools suggest that inpatient admission is appropriate, yet they nevertheless challenge the decision to admit the patient. For reasons that will be detailed in a future article, there are very strong legal arguments to support a physician’s decision to admit the patient in these cases as well.
About the Author
David Glaser is a shareholder in Fredrikson & Byron's Health Law Group and helped establish its Health Care Fraud & Compliance Group. David helps healthcare entities negotiate the maze of healthcare regulations, providing advice about risk management, reimbursement and business planning issues. He has considerable experience in healthcare regulation and litigation, including compliance, criminal and civil fraud investigations, and reimbursement disputes.
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