When the Feds Come Knocking

Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for reasons outside of the criteria set forth in Medicare’s National Coverage Decision (NCD).  This investigation occurred just after Al-Khatib and others published a report January 4, 2011 in JAMA that suggested as many as 22.5% of implantable defibrillators implanted for primary prevention of sudden death were not evidence-based.  While the physician community took issue with the Al-Khatib paper, the media firestorm it generated paired with the announcement to the Heart Rhythm Society physician community that a federal investigation was underway, had a chilling effect on ICD implantation nationwide.  Drs. Jonathan S.Steinberg and Suneet Mittal report on their experience with DOJ investigators under this heavy regulatory oversight in today’s Journal of the American College of Cardiology.

Steinberg and Mittal's diplomatic account carefully describes the challenges of retrospective audits performed by lawyers from the Department of Justice and those of their targeted health care facilities. The DOJ identified 229 cases as potentially inappropriate cases based on Medicare code criteria.  (This represented 8.7% of the de novo non-resynchronization ICD implants done for primary prevention at their institutions). After determining that some of these targeted cases were actually for secondary prevention or other coding transgressions, the authors could medically justify all but thirty-four (15%)  (or a very low 1.5% of all ICD’s implanted for primary prevention of sudden death) at their institution.  As has been the case in most reports, the majority of outside NCD-directed ICD implants occurred because of timing violations—too close to the diagnosis of heart failure, heart attack and coronary intervention. These timing constraints constitute the primary issue before implanting doctors: their professional society guidelines do not -- in all cases -- recognize similar timing restrictions.

It is surprising that we are not told what sanctions, if any, were levied against their respective institutions.   Perhaps the authors felt this important detail was unimportant to disclose or perhaps they were prohibited from doing so.  Perhaps their penalty is still being determined: after all, nothing drives behavior like fear.  To this end, we found the authors' compliments of the government's legal team unusual to report in a scientific manuscript, as if the they were suffering from Stockholm Syndrome.

We should acknowledge that the authors have added much needed clarity to the gray area of decision-making surrounding ICD implantation. Their explanations of timing violations highlight problems with coding, confusion around incidental PCI intervention in patients with dilated cardiomyopathy, and demonstrate the overlap decisions that must be made when bradycardia and tachycardia functions might be required for our patients.  This kind of clinically-relevant nuance was lacking in the impugnable Al-Khatib JAMA piece.

We can only speculate the large cost of the legal fees and man-hours devoted to this review process.  We will never know how many patients died during, or now after, the course of this investigation because they were not offered ICDs because ICDs can only be offered to patients who meet Medicare’s rigid, outdated, and still-to-be-updated National Coverage Decision for implantable defibrillators.   But perhaps this is the price of regulation that America is willing to pay in return for cost savings.  Perhaps we should not be concerned that professional guidelines for care delivery should be second fiddle to government mandates for ICD implantation.

With this latest report, a new era for medical practice is now upon us – one where priorities of low cost care and high quantity of care determined by non-medical personnel supersede the highest quality of medical care to our patients.   For regulators, it is easy to be a Monday-morning armchair quarterback evaluating health care delivery.  It is far harder, however, to decide prospectively who is likely to die (or not) when they sit before you with a newly-diagnosed cardiomyopathy and ejection fraction of 12%. 

When government and legal officials who carry no responsibility for the long-term well-being of our patients have the authority to retrospectively impugn and penalize doctors (and their health care facilities) based merely on retrospective reviews of billing codes and outdated payment mandates, they risk irrevocable harm to patients who might qualify for devices according to updated professional guidelines.  Doctors everywhere should stand up collectively to disown the practice of using NCD mandates, rather than updated professional guidelines, to determine appropriate care for patients.

After all, our patients are depending on us.

Westby G. Fisher, MD
Director, Cardiac Electrophysiology
NorthShore University Health System and
Clinical Associate Professor of Medicine
Pritzker School of Medicine, University of Chicago
Evanston, IL

John Mandrola, MD
Cardiac Electrophysiologist
Baptist Medical Associates
Louisville, KY

Addendum 27 Mar 2012: Link to Steinberg/Mittal article finally added.

Addendum 14 Sep 2012: Update on the DOJ Decision

References:

Jonathan S. Steinberg and Suneet Mittal. "The Federal Audit of Implantable Cardioverter-Defibrillator Implants: Lessons Learned." J Am Coll Cardiol. April 3, 2012, 59 (14) 1270-4. doi: 10.1016/j.jacc.2011.12.026

Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. J Am Coll Cardiol. May 27, 2008;51(21):e1-62.

Al-Khatib S, Hellkamp A, Curtis J, et al. Non–Evidence-Based ICD Implantations in the United States JAMA. 2011;305(1):43-49. doi: 10.1001/jama.2010.1915

Note: This post also appears on Dr. John Mandrola's blog: http://www.drjohnm.org/

A Lawyer's Perspective on the DOJ's Investigation of Implantable Cardiac Defibrillator Use

From the lawyer-published "Healthcare Compliance Blog:"

I predict that the DOJ will be:

1.Continuing its efforts to deal with providers in an open and collaborative manner.
2.Notifying more hospitals that they are under investigation relating to ICD billing.
3.Making additional inquiries of hospitals regarding this matter.
4.Investigating doctors who have patterns of high ICD implantation rates, coupled with a potential lack of medical necessity. The medical necessity issue poses risks to both physicians and hospitals.

These are not really hard predictions to make, though I would argue that the DOJ has been anything but "open and collaborative" as they have imposed a gag order on the Heart Rhythm Society during their current investigation.

But we must acknowledge there are implanters who have scammed the system and they should be held accountable for their actions. But for the myriad of physicians who are implanting devices appropriately, no one quite knows what to do with their patient's since the government's CMS-directed guidelines are so out of date. As I mentioned before, CMS wants doctors to use their ICD guidelines based on data from 2005 that ignores the more recently published (and less restrictive) guidelines published in 2008.

We are now seeing the Draconian and covert methods that will be used to impose restrictions on our patient's care. This model will serve the government operatives for other expensive technologies, too, like hip replacements, spinal fusions, and the like.

Whether the government begins to prosecute doctors for using the newer ICD implantation guidelines remains to be seen, but the mere specter that they're looking has already achieved the government's goal since no one wants the expense and notariety of a legal investigation to contend with and as a result, ICD implantation rates are currently dramatically reduced.

Mission accomplished.

-Wes

DOJ Investigating Defibrillator Implanters

From the Heart Rhythm Society member's website today:

"The Heart Rhythm Society (HRS) is aware of an ongoing U.S. Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants and has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making. As an advisor to this investigation, HRS is reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ. Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ."

This action comes, no doubt, on the heels of the recent publication in JAMA which reviewed an ICD registry of implantation practices in America from 2006 to 2009 and found 22% of ICD implants were implanted outside published guidelines.

Now all of us know people make money implanting ICD's, including me. Given the time, the expertise, and the management issues involved with the 24/7 care of the patients with these devices, they should.

But no one wants to waste money to our health care system, either, and we must acknowledge there's been a heck of a marketing push to get more devices implanted. This has occurred because many patients who might benefit (legitimately) from these devices remain untreated and, yes, hospitals and medical device companies benefit handsomely from these procedures.

But before witch hunts ensue, we should take a moment and consider the implications of the DOJ's current actions.

First of all, I think most of us would acknowledge that every set of clinical guidelines published has holes. (One only has to look at the latest published atrial fibrillation management guidelines to note that the use of the newly-released anticoagulant dabigatran (Pradaxa) is not mentioned in those guidelines, rendering them already obsolete). Further, the studies upon which recommendations are made in published guidelines are often made on relatively weak data or by people with substantial industry ties. Further, prospective randomized trials are rarely used to make those recommendations.

Simply put, there is no way a published document can cover every clinical circumstance a doctor might encounter when he or she is in the trenches with an individual patient.

So this begs a simple question: If guidelines are not perfect and we must accept that doctors must deviate from them from time to time to work toward the best interest of their patient, what IS the percentage of care (in this case, ICDs) that SHOULD fall outside of guidelines?

Is 0% the correct number?

Clearly, no.

Is 5%, 10%, 15%, 20%, 22%?

The reality of this situation is that no one knows.

But that does not seem to be stopping the DOJ from investigating doctors for their criminal intent...

... based on the guidelines, of course.

-Wes

References:
Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA 2011; 305:43-49.

Dr. Rich over at the Covert Rationing blog appropriately rips the abuse of the ICD guidelines in his must-read essay.

John Mandrola, MD, another EP, gives his take.

Larry Husten, at Cardiobrief, summarizes.

21 Jan 2011: An now, thanks to new SCD-HeFT data, maybe the 40-day wait period post-MI for ICD's is not such a good idea. Oh wait, that's not in the guidelines.

Providing Health Care Will Get You Investigated

When I started medical school if someone had told me that providing health care to my patients would be grounds for a Department of Justice inquiry into the care I delivered, I would have laughed in their face. But the government's desperate financial times require desperate measures. From the Report on Medicare Compliance:

Both the Department of Justice (DOJ) and the Recovery Audit Contractors (RAC) are focusing investigations on Medicare billing for implantable cardiac defibrillator (ICD) surgery. The reimbursement rate for ICD surgery is one of the higher dollar Medicare Severity Diagnosis Related Groupings (MS-DRG). The DOJ’s investigation is focusing on both medical necessity and MS-DRG coding validation issues, while the RACs are currently only conducting MS-DRG validation reviews. According to the CMS national coverage determination (NCD), Medicare pays for ICD implantation for eight specific conditions. However, there are many circumstantial limitations to coverage in these conditions that often lead to CMS not covering the implantation. For example, the beneficiary must not have had an acute myocardial infarction within 40 days prior to surgery. If a hospital being investigated by the DOJ performed the implantation despite this condition, the DOJ is requiring them to justify why they thought the surgery was medically necessary. The DOJ is sending out document production requests, requesting all documents related to ICD implantation coding, billing, payment, reimbursement, payment denials and ICD-related appeals by all payers. Additionally, RACs are conducting coding and validation reviews of MS-DRGs related to ICD surgery. When conducting validation reviews, the RACs are looking at the beneficiary’s medical record, specifically the diagnostic and procedural information and discharge status, to determine whether the ICD surgery MS-DRG code listed is supported by the proper documentation.

Consider yourself warned, criminals.

Remember that malpractice litigation we were worried about? What were we thinking?

Those were the good ol' days.

-Wes

Reference: “Justice Dept. Investigates Hospitals for Cardiac Billing in New Spin on RAC Risk.” Report on Medicare Compliance Vol. 19, No. 15. 26 Apr. 2010; 1, 5.