The U.S. Dept. of Justice offered hospitals nationwide a guide to responding to a federal investigation into heart implants and Medicare billing, but the American Heart Assn. warned that some of the agency’s guidelines may end up hurting patients.
The DoJ issued an ICD investigation resolution model through which hospitals can determine whether an implanted cardiac defibrillator meets Medicare criteria and can thus be excluded from the investigation.
It appears to be a new approach for the DoJ and the Centers for Medicare & Medicaid Services in dealing with potential Medicare fraud, but the one-size-fits-all guidelines may target some justified implants and chill physicians’ judgment in making calls that are best for their patients, the AHA warned.
The DoJ and CMS are asking hospitals to submit documents and records relating to Medicare-reimbursed ICDs, each of which will be individually assessed for inclusion or exclusion from the ongoing investigation, according to the guidelines. The agencies further asked the hospitals to quantify the "damages" for each claim, amounting to the difference between what the facility was paid and what it should have been paid.
Certain patients may need ICDs but not fit within the stated guidelines. Some patients, for example, my have had an heart attack in the past but didn’t receive an implant until after experiencing a separate event. That implant is still considered justified for Medicare reimbursement, but only if it fits within a given time frame.
"The American Heart Association supports the Centers for Medicare & Medicaid Services and the Department of Justice in their efforts to eliminate billing fraud for implantable cardioverter defibrillators," according to an AHA press release. "But, it also is critical that such efforts not compromise quality of patient care, or infringe on a physician’s legitimate medical judgment concerning what is best for the patient. To that end, efforts to eliminate billing fraud must be balanced with allowing physicians to make expert judgments and determine care in consultation with their patients."
The DoJ outreach is the latest in a long-running probe into hospital implant practices, during which the federal agency has met with officials from organizations including the AHA, American College of Cardiology, and the Heart Rhythm Society in order to shape the proposed settlement framework.
In an email accompanying the guidelines sent to hospitals the DoJ said it will not penalize every device that falls outside of CMS rules for reimbursement, ModernHealthcare.com reported.
Last month hospital chain HCA Holdings (NYSE:HCA) revealed that it was the target of a federal probe into its ICD practices. The DOJ will review certain billing and medical records at 95 HCA sites covering a period from October 2003 to the present, according to HCA’s latest financial report.