CMS, DOJ, HRS, and ICDs: An Urgent Need for Clarity

Establishing the Controversy

In 2011, an article published in the Journal of the American Medical Association (JAMA) caused unprecedented controversy regarding implantable cardioverter defibrillator (ICD) procedures, leading to angst and changes in practice among ICD implanters and the healthcare administrator community. The study concluded that 22.5% of ICD implants between 2006 and 2009 were “non-evidence-based.” The retrospective data was drawn from the NCDR^® ICD Registry^™. Al-Khatib et al¹ qualified these “non-evidence-based” ICD implants as meeting the following criteria:

1. The device implant was within 40 days of a myocardial infarction (MI).
2. The device implant was within 90 days of coronary artery bypass grafting (CABG).
3. The patient had New York Heart Association (NYHA) class IV symptoms.
4. The patient was recently diagnosed with heart failure.

The study also broke down ICD implantation and necessity by specialty. Electrophysiologists (EPs) implanted 66.6% of ICDs and had the lowest rate of “non-evidence-based” implants at 20.8%. Procedures performed by non-EP cardiologists, thoracic surgeons, and other specialists were considered to have more “non-evidence-based” ICD implants.¹ ICDs implanted out of the prespecified time window had higher complication rates, but also had more comorbidities (and there was no long-term follow-up data).

Nearly contemporaneous but not directly related to this manuscript, the Department of Justice (DOJ) announced that it was investigating ICD implants as related to proper guidelines for clinical decision making. The premise appeared to be that presenting cases (reimbursed by the Centers for Medicare and Medicaid Services [CMS]) must meet the CMS criteria to qualify for an ICD implant. The American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) released a joint statement regarding the recent Al-Khatib article. In part, it states:

“The message and teachings of this important study indicate that substantial variations exist among hospital ICD implantation strategies. This variation clearly demonstrates an opportunity for improvement in care delivery. The findings are critical for the cardiovascular community and our patients in moving forward our commitment to change practice patterns to deliver higher quality, evidence-based, cost-effective care.”³

There was initial concern that the investigation would have a negative impact on public health. It is unlikely that reasonable off-guideline cases of ICD implants will be prosecuted, and it is likely that the DOJ will go after the outliers, the physicians actually abusing the system.

Strengths and Limitations of the NCDR^® ICD Registry^™

The NCDR^® ICD Registry^™4,5 was developed through a partnership of the American College of Cardiology Foundation and the HRS. The database was mandated by CMS to document Medicare’s primary prevention patients receiving ICD implants. While it was designed for Medicare patients, approximately 95% of all ICD procedures in the U.S. are entered into the registry. The strength of the NCDR^® ICD Registry^™ is derived from the number of patients included in the registry, representing over 525,000 implants since the advent of the NCDR^® ICD Registry^™. The intent of the registry is to examine outcomes of ICD implantation in the “real world” and measure site-specific outcomes as they relate to national statistics.⁶

The registry is able to record patient demographics, provider and facility characteristics, and device type and characteristics,⁴ but it is not set to capture nuances presented by individual patients. Clinical inferences based on single data points with no follow up can be misleading.

One major shortcoming of this study is lack of demonstrated accuracy of the data collection. Another is the inability to address whether the physician’s judgment to do a “non-evidence-based” procedure was correct and the patient benefited. Epstein et al point out the general population will not match exactly the trial population from which the predictive models have been derived.^5,6

As is often the case, patients may not fall within accepted guidelines, and physicians must exercise judgment based on all available data to provide a final determination for ICD candidacy. Using the NCDR^® ICD Registry^™ data to categorically assess whether a clinical site is performing “non-evidence-based” vs. “evidence-based” device implantations is problematic, since it does not take into consideration physician judgment/expertise. Furthermore, it does not prospectively track this “non-evidence-based” patient to assess for long-term benefit.

Guidelines are NOT Rules

If an ICD procedure falls outside of the set guidelines, Al-Khatib et al¹ qualified these ICD procedures as “non-evidence-based.” When did the guidelines move from being recommendations to becoming mandates? Guidelines are by definition a general set of factors that one ought to take into consideration, not absolute rules. It is ultimately up to the doctor to decide whether an ICD is appropriate for a given patient. Al-Khatib et al did stress that “the ultimate judgment regarding care of a particular patient must be made by the physician and the patient in light of all the circumstances presented by that patient. There are circumstances in which deviations from these guidelines are appropriate.”¹ However, their publication did not account for the evidence or patient outcomes of ICDs that were implanted outside of their guidelines. Considerable variation exists between institutions regarding these out-of-guideline implantations (which are not reflected within the ACC/AHA/HRS guidelines). Many patients outside these guidelines appropriately receive ICDs based on clinical judgment and patient presentation.⁶

Certainly, conscientious healthcare practitioners make every effort to follow clinical guidelines with respect to ICD implantation. However, there are clear medical scenarios that provide exception to our guidelines:

1. Scenario 1: Patient presents for cardiac revascularization (PTCA/CABG) for coronary artery disease. The patient has a history of a remote MI greater than 40 days ago. The ejection fraction is <40%. The patient is having nonsustained ventricular tachycardia (3 beats) more than one week post revascularization. Based on the MUSTT study,⁷ this patient would qualify for electrophysiology testing for sudden cardiac death risk stratification and if sustained hemodynamically significant ventricular arrhythmia was induced, an ICD may be associated with improved outcomes.
2. Scenario 2: Patient is admitted with an acute anterior wall MI due to occlusion of the left anterior descending artery, creating complete heart block. The patient had a preexisting ejection fraction of 15% prior to the MI and is a class II NYHA CHF patient. This patient would have qualified for an ICD implantation if it were not for the recent MI. This patient will require at the minimum pacemaker therapy, but is at clear risk for sudden arrhythmic death. Should this patient be given an ICD to save the patient a future operation and anesthesia exposure? Should this patient be given a biventricular ICD given the anticipated frequent RV pacing?  
3. Scenario 3: Patient presents with a heart failure exacerbation episode to the hospital despite being on optimal medical therapy. He has a “low level” troponin leak secondary to left ventricular stretch/dilation typically seen with acute decompensated failure. The patient has a LBBB QRS 170 msec, EF 15%, Class III NYHA CHF and a life expectancy greater than one year. The referring cardiologist has labeled the troponin leak as a myocardial infarction. Should this patient be made to wait the obligatory 40 days post myocardial infarction? Are all troponin elevations to be treated as a de facto myocardial infarction? What options are available to the physician to appropriately document in the medical chart how a low level troponin elevation does not necessarily define a heart attack?

Those Guideline Do We Follow? A Need for Better Harmonization Between CMS and the ACC/AHA/HRS

There are significant differences between the guidelines set forth by the ACC/AHA/HRS and CMS. The ACC/AHA/HRS provide detailed guidelines for patients meeting the criteria to receive an ICD for primary prevention purposes based on the best evidence. Their criteria include, but are not limited to, coronary artery disease, nonischemic dilated cardiomyopathy, long QT syndrome, hypertrophic cardiomyopathy, noncompression of left ventricle and primary electrical disease. Each of these categories is supported by clinical trials.

One particularly vexing problem is the establishment of definitive timelines regarding the onset of heart failure symptoms. Packer et al clearly stated the use of a three-month cutoff for establishing whether implantation falls within or outside of the published guidelines cannot be implied from recommendations presented in the 2008 ACC/AHA/HRS guidelines. [ClassI.5.: ICD therapy is indicated in patients with non-ischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional class II or III. (Level of Evidence: B)].⁶ Furthermore, the use of a time qualifier relative to the time since diagnosis of a non-ischemic DCM may not reliably discriminate patients at high risk for SCD in selected populations.⁶

It is clear that there is an emerging divergence in the practice of healthcare as it relates to implantation of ICDs. When such an extensive body of literature has been developed by numerous medical societies on when to appropriately provide lifesaving ICD therapy, why then should a CMS patient be denied this medical miracle if they clearly meet the 2008 ACC/AHA/HRS guidelines, but not the 2005 CMS guidelines? 

What Have We Learned From the DOJ Investigation?

Unfortunately, nothing yet. The HRS has not effectively communicated to its physician members in a time when clarity is required. In response to the DOJ investigation announcement, the Heart Rhythm Society released the following on January 20, 2011:⁸

“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 is not available for further comment.”⁸

More than a year has elapsed since the DOJ investigation has begun, and no update has been given to the thousands of physicians caring for patients. Across the United States, healthcare institutions, along with physicians and legal counsel, have formed working relations to help police appropriate utilization of ICD therapy. The impetus is a looming threat of punitive action against an institution levied by the DOJ. Additional layers of administrative burden have been placed on hospitals and physicians. Many of the difficult questions and clinical scenarios we face can be aided by expert updates by our leaders in HRS. Our patients’ lives hang in the balance. 

Conclusion

The NCDR^® ICD Registry^™ was in part intended to reflect “real world” ICD implantation. I urge HRS to provide leadership and clarity at a critical time. I urge HRS to seek permission from the DOJ to provide timely and informative communications to physician members as we work to care for our patients. I urge them to better align CMS guidelines for ICD implantations with the current 2008 ACC/AHA/HRS ICD guidelines and help provide guidance on common clinical scenarios that do not fall within standard guidelines.

It is incumbent upon us to protect the sanctity of physician judgment and remind CMS and the DOJ that while the application of registries and law may be “black and white,” the care of our patients frequently is not.

Acknowledgement. Dr. Anand would like to thank Ms. Tiffany Hunt for assistance with manuscript preparation. Furthermore, Dr. Anand is grateful to those esteemed colleagues who have provided insight and assistance in manuscript preparation.

References

1. Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA 2011;305:43–49.
2. NCDR^® National Cardiovascular Data Registry ICD Registry, 2006. Accessed 10 Apr. 2012. <https://www.ncdr.com/webncdr/ICD/>.
3. Joint Statement from ACC and HRS on Recent ICD Study. HRS Online. 5 Jan. 2011. Accessed 10 Apr. 2012. <https://www.hrsonline.org/News/Media/press-releases/acc-hrs_ICDstudy-statement.cfm>.
4. Using registries to assess clinical practice and improve patient care. Mayo Clinic. Web. 10 Apr. 2012. <https://www.mayoclinic.org/medicalprofs/using-icd-registries.html>.
5. Epstein AE, Dimarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities. Heart Rhythm 2008;5:e1–62.
6. Packer DL, Gillis AM, Calkins H, et al. ICDs: Evidence, guidelines and glitches. Heart Rhythm 2011;8:800–803.
7. Buxton AE, Lee KL, Fisher JD, et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med 1999;341:1882–1890. 
8. Heart Rhythm Society Statement Regarding Department of Justice Investigation. HRS Online. 21 Jan. 2011. Accessed 10 Apr. 2012. <https://www.hrsonline.org/News/Media/press-releases/HRS_DOJstatement.cfm>.