* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

There are reports of breakthrough healthcare treatments virtually every day. Heart disease – one of the leading causes of death in the United States – is no exception. Through advances in technology and other factors, certain life-saving procedures, which in the past could only be performed in the hospital setting, are now routinely performed at thousands of stand-alone surgery centers specializing in cardiac care which have cropped up throughout the country. Recently, state and federal authorities have taken action against some of these surgery centers, as well as hospitals, demanding a cessation of practice or refusing to provide reimbursement on a variety of grounds.

California Claims Statute Requires Cardiac Catheterizations to be Performed In Hospitals

For example, the California Department of Public Health (“CDPH”) has taken the position that pursuant to state statute, surgery centers are prohibited from performing two potentially life-saving procedures: insertion or placement of permanent pacemakers (“PPMs”) and Automatic Implantable Cardioverter Defibrillators. CDPH has sent at least one cease and desist letter to a surgery center in Northern California, demanding that it immediately stop providing such procedures. CDPH’s position is based on a California statute prohibiting cardiac catheterizations from being performed outside of general acute care hospitals. The statutes involved, Health and Safety Code Section 1255 and 1255.5, provides that cardiac catheterizations include, “an intravascular insertion of a catheter into the heart for the primary definition and diagnosis of an anatomic cardiac lesion.” CDPH argues that the statute prohibits insertion and placement of PPMs and defibrillators outside of a hospital setting because such procedures include the intravascular insertion of a catheter into the heart and therefore are covered by the statute. If it is enforced, CDPH’s position would severely limit access to these life-saving cardiac procedures by limiting their availability to general acute care hospitals only.

The cardiology industry has responded to CDPH’s position by asserting that the referenced procedures do not violate the California statute because they do not involve diagnosis of a cardiac lesion, but rather their treatment. According to the industry, the distinction between diagnosis and treatment under these circumstances is significant. Cardiac catheterization is performed after the patient has had a heart attack or is at high risk for other reasons. The findings from the cardiac catheterization process allow the cardiologist to define the cardiac lesions, render a diagnosis, and formulate a treatment plan. In contrast, PPM and defibrillator procedures are not performed for the purposes of diagnosis, but for the sole purpose of treatment after diagnosis has taken place. Cardiologists point out that such treatment procedures are safer than cardiac catheterizations because the patient’s cardiovascular risk at the time of the treatment procedure has already been assessed (the cardiologist already knows the location of plaque and/or where thinning of arterial walls has occurred). Moreover, the referenced treatment procedures do not involve the insertion of die (as do cardiac catheterizations) and are performed by making an insertion into the upper chest rather than accessing the heart through a peripheral artery (which is the process utilized during catheterizations). These distinctions, argue the industry, make the PPM and defibrillator procedures performed at surgery centers safe and prudent. The cardiology industry also argues that access to potentially life-saving cardiac care is far greater at one of the many surgery centers now located throughout the country than at the nation’s overcrowded hospitals.

Medicare Requires Waiting Period Before Performing These Procedures

Stand-alone surgery centers are not the only providers having to deal with enforcement actions relating to life-saving cardiac care. The Federal Department of Justice, Civil Fraud Division, has filed actions under the False Claims Act against 1300 hospitals nationwide for performing the same implants. Rather than arguing that the hospital was not authorized to perform such procedures (which is clearly not the case), it argued that the hospitals made false claims because they billed Medicare for implantable defibrillators outside of Medicare’s requirements for coverage. The Medicare guidelines for coverage prohibit hospitals from billing Medicare for devices implanted sooner than 40 days after a heart attack or 90 days after bypass or angioplasty, in order to give the heart sufficient time to stabilize and improve. These guidelines were set in 2005 based on clinical trials and guidance from professional cardiology societies, manufacturers, and patient advocates. While acknowledging the guidelines, the industry’s response is that in some cases, there were compelling medical reasons to perform the procedures earlier. Nonetheless, the Department of Justice received millions of dollars in settlement from some of the nations’ largest hospital systems.

Providers Should Take Action to Ensure Compliance

It remains to be seen how far state and federal authorities will go in scrutinizing such important, potentially life-saving cardiac care. It is also unknown if their prior actions have already adversely affected access to such critical care and if they have, what impact there will be on the delivery of cardiac care services in the future. Based on the examples discussed above, it would seem that from the provider’s perspective, there are some issues to consider in order to remain compliant and safeguard their eligibility for reimbursement. Providers specializing in cardiac care should develop a comprehensive log of all services performed and codes billed. They should carefully reference their state law as well as Medicare guidelines to ascertain whether they are compliant under all applicable law and other requirements for the provision of and billing for all services. If there is medical necessity to provide the care outside of applicable rules and guidelines, it may make sense to contact your Medicare contractor for pre-authorization.