December 23rd is the deadline to make recommendations directly to the Department of Health and Human Services (HHS) regarding which Medicare regulations and policies should be eliminated or revised to remove administrative burden and improve the quality of healthcare.1 I am personally submitting a recommendation that will reconcile coverage guidelines for cardiac rhythm management devices with evidence-based criteria. This editorial explains what I believe is our opportunity to influence Medicare policy; I will be submitting a copy in its entirety to HHS as the first of several recommendations.
In Executive Order 13563, President Obama demanded that our regulatory system “must be based on the best available science. It must allow for public participation and an open exchange of ideas. It must promote predictability and reduce uncertainty. It must identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends. It must take into account benefits and costs, both quantitative and qualitative. It must ensure that regulations are accessible, consistent, written in plain language, and easy to understand. It must measure, and seek to improve, the actual results of regulatory requirements … agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.”2
In response to this Executive Order, CMS issued proposed rule 9070-P. In this proposed rule, CMS invites public comments regarding which rules should be targeted for revision or elimination. It specifically says, “If, at any time, members of the public identify possible reforms to streamline requirements and to reduce existing burdens, HHS will give those suggestions careful consideration. Therefore, along with this proposed rule, we seek ideas from the public to help identify areas for possible reform.”1
In addition to submitting this to the HHS, I will be submitting additional recommendations aimed to eliminate the evaluation and management service documentation guidelines, to postpone the implementation of ICD-10, to terminate the Recovery Audit Contractor initiative, and to eliminate Medicare Administrative Contractor influence over medical necessity guidelines and payment levels for Medicare services. Each of my submissions will be available for viewing at www.CardiologyCoder.com and on my LinkedIn profile page (http://www.linkedin.com/pub/jim-collins/11/b7b/63a).
At present, thousands of patients are not receiving the best care possible because Medicare is aggressively enforcing coverage policies that are not in line with evidence-based practice. Among the most outdated policies are those specific to pacemaker and defibrillator implantation. The defibrillator policy was last updated in 2005, and the pacemaker policy in 1985.
Medicare’s enforcement of these outdated policies has triggered penalties for many physicians who are guilty of nothing but providing the best care possible for their patients. This includes implanting dual chamber pacemakers in patients whom the 1985 coverage policy suggests would be adequately served by a single chamber system instead, and implanting defibrillators in patients within 40 days of a myocardial infarction or within three months of either coronary angioplasty or onset of non-ischemic dilated cardiomyopathy. In response to these investigations and penalties, many physicians have become overly conservative when treating patients — depriving patients of lifesaving therapy and exposing themselves to considerable malpractice risk.
The divergence of evidence-based practice and Medicare policy is fueled by the fact that there are no mechanisms in place to update Medicare coverage policies when compelling evidence is identified. For example, the MADIT-CRT trial concluded in June 2009 after revealing “a 34% reduction in the risk of death or nonfatal heart failure (whichever came first) among patients in the CRT–ICD group, as compared with those in the ICD-only group.”3 Although the treatment of heart failure is the largest expense in the Medicare program, Medicare has not updated the pacemaker or defibrillator coverage policies since the MADIT-CRT trial concluded.
It seems wasteful and abusive that Medicare has not attempted to secure a return on its investment for all of the consultations, surgeries, devices, and lifetime follow-up it paid for to facilitate the MADIT-CRT trial. Equally as concerning is that 1,820 patients subjected themselves to experimental major surgery under the impression that they would be contributing to a greater good — an attainable goal that is yet to be achieved.
Unfortunately, MADIT-CRT is not the only trial that has met this fate. Hundreds, potentially thousands, of others just like it have sculpted evidence-based practice standards for devices, ablation techniques, vascular interventions, and pharmaceutical use. Some of these trials illustrate that Medicare should expand coverage; some of them suggest that coverage should be further limited. Whether trial data expands or constricts coverage for any given procedure or device, the quality of care cultivated by Medicare policy would be substantially improved if it was kept up to date with evidence-based standards.
Medicare and the general public have access to clinical trial data through the U.S. Food and Drug Administration (FDA) website (www.fda.gov). Therefore, how Medicare has allowed the national coverage policies to atrophy to such an alarming degree is inexcusable.
Medicare accuses healthcare providers who waiver from the coverage policies of committing fraud and abuse. In reality, I believe Medicare policy is a more expensive form of tax fund abuse, and it harms patient care more than any of the investigative targets currently being pursued by the Department of Justice, the Office of Inspector General, and Recovery Audit Contractors.
While it seems logical that specialty societies would be the best organizations to analyze clinical trial data and update coverage policies, their current efforts appear to be focused elsewhere. Instead of narrowing the gap between evidence-based standards and Medicare coverage policy, many specialty society actions have driven a wedge between them. For example, when asked to confirm or deny the appropriateness of defibrillator implantation following sudden cardiac arrest (SCA), sustained ventricular tachycardia (VT), or ventricular fibrillation (VF) which happens at any point within 90 days following coronary angioplasty, a member of the Heart Rhythm Society (HRS) Board of Trustees and a member of the HRS Health Policy indicated that they could not comment due to a non-disclosure agreement they entered with the Department of Justice (DOJ).4 Later, it became clear that the HRS entered a relationship with the DOJ to assist in their investigations of inappropriate defibrillator implants weeks after the Journal of the American Medical Association (JAMA) published an article asserting that over 20% of defibrillator implants are not indicated.5
Hopefully, the HRS will illustrate to the DOJ that many of the problematic implants referenced in the JAMA article were truly in line with the National Coverage Determination. For example, “patients with newly diagnosed heart failure” constituted 62.1% of the implants touted as being “non–evidence-based” in the JAMA article.5 The problem with this is that “newly diagnosed heart failure” is not an exclusion in the National Coverage Determination for defibrillators. The JAMA article acknowledges this by mentioning that the guidelines merely “imply that ICD therapy is not recommended for patients with a new diagnosis of heart failure.”5
“Implication” is not a factor in determining compliance with Medicare policy; auditors are instructed to apply the standards in a black and white manner. Only three “wait periods” are outlined in Medicare’s National Coverage Determination for defibrillators.6 The first two attempt to exclude patients who have a temporarily reduced ejection fraction or heart failure exacerbation that resulted from a transient or reversible cause. With optimal medical therapy, a patient’s heart failure status and ejection fraction may improve in the prescribed wait periods (three months following revascularization and 40 days following acute myocardial infarction). However, the coverage determination does not require providers to reassess the patient’s heart failure status or ejection fraction at the conclusion of the prescribed wait period — so one just needs to count down the days and then put the device in.
The third wait period is more convoluted. The policy requires a wait period for patients qualifying for implant indication #7: “Patients with non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart failure, and measured LVEF < 35%.”6 This nine-month wait period is reduced to three months in the text of indication #9, which says one only needs to wait three months if “The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (NCD Manual §310.1), or a prospective data collection system… For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.”6 A CMS official has confirmed that “The ACC-NCDR® is an approved registry and meets the data reporting requirements for all primary prevention indications listed in the ICD National Coverage Determination.” Since Medicare requires all primary prevention patients to be enrolled in the NCDR® ICD Registry™, provision #9 effectively reduces the nine-month wait period referenced in indication #7 to just three months for all patients.
In addition to the absence of exclusion criteria for “newly diagnosed heart failure,” the date of non-ischemic dilated cardiomyopathy onset is a guessing game at the time of data entry. Implanting physicians do not always have an exact date of onset available. If the data entry staffers are not provided with the date of onset, they reportedly default to the date of admission for the implant. Since the date of admission is less than three months from the date of implant, these implants would appear to be not indicated. In reality, many of these devices were indicated.
HRS’ relationship with the DOJ is most likely going to result in the illumination of flaws like this in the JAMA article and in the cases currently being investigated. Their intent is most likely to prevent physicians from being inappropriately prosecuted. However, if the HRS cannot clarify if secondary prevention indications (VT, VF, SCA) supersede the primary prevention wait periods, this could be perceived as a major conflict of interest and a disservice to their members. It effectively exposes doctors to prosecution for doing what is best for the patient — device implantation.
The manner in which the American College of Cardiology (ACC) designed and operates the registry from which the JAMA article based its controversial conclusions is I believe even more concerning. As referenced above, Medicare made it mandatory for all hospitals to submit data to the ACC’s NCDR® ICD Registry™ as a requirement to secure payment for any primary prevention defibrillator implant.7
The goal of the registry is to “allow Medicare and researchers to track how well the devices perform in various groups of patients over time.”8 As published in the Washington Post in January 2005, Medicare’s requirement for patients to be enrolled in a registry “represents the most aggressive effort yet to use [Medicare] as a backdoor way to learn more about what works and what does not in medicine.”9
The opportunity presented by this nationwide data registry is tremendous. Since it includes all primary prevention and the majority of secondary prevention implants, it captures data from many more patients than any of the individual clinical trials that shaped the current constellation of indications. Ideally, we would identify which characteristics are shared among the patients who receive lifesaving therapy after implant. This first pass of data analysis would shape a more appropriate and more serviceable subset of implant indications. However, if a patient receives lifesaving therapy from their device while walking to the parking deck after their implant, no data gets entered into the registry. Nothing is entered into the registry except at the time of device implant or revision.
Taxpayers have paid billions for the devices in the registry, hospitals have paid thousands for the right to submit data to the registry, and healthcare providers have dedicated countless hours to capture an extensive set of data variables at the time of these procedures. But rather than enhancing patient care and reducing healthcare expenses, the registry is little more than an administrative burden that adds expenses to healthcare. Much of the data collected by the registry is unnecessary, the process of collecting and submitting the data is burdensome on health care providers, and the registry does not overtly improve patient care. Instead, it has been used to fuel speculation of wrongdoing.
Similar to industry-coordinated trials, Medicare’s coverage of primary prevention defibrillator implants is an investment in clinical research — this is why they mandated enrollment in a registry. To reap a return on this investment, we should assess device interrogation data — not the data that is currently captured by the registry. In this age of standardized electronic transactions, it would be relatively easy to compile and analyze data from every device interrogation performed in the country. We could easily perform subgroup analysis of those patients who experience arrhythmias, who successfully cardiovert, who require defibrillation, and whose QRS improves. Simply by identifying the commonalities among patients who received lifesaving therapy, a more appropriate subset of indications would quickly emerge.
This data compilation would also provide reliable insight regarding the following:
- Which generators and leads need to be recalled?
- What are the optimal device settings (pulse width, amplitude, A-V delay, V-V delay, etc.)?
- Which batteries last the longest?
- Which device features disproportionately consume battery?
- Who is best suited to follow devices: electrophysiologists, general cardiologists, or primary care doctors?
Automated capture of objective device interrogation data will ensure that the data is unadulterated by data entry error and manipulation. The data will allow patients, hospitals, insurers, and implanters to analyze device and programming options in ways that substantially improve patient care and significantly reduce healthcare costs. Medicare needs to be held accountable to tax payers and be responsive to clinical trial data. This proposed effort will achieve both of those goals.
Please lend your support to these initiatives and submit your own recommendations regarding other rules that should be modified directly to the HSS. You can submit your comments and recommendations at http://www.regulations.gov — select the “submit a comment” tab, select “proposed rule” as the document type in the drop-down menu, and enter “CMS-9070-P” in the search field. At the bottom of the “search results” window you will see a place to submit a comment regarding “Medicare and Medicaid Programs: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.” All submitted comments will be given careful consideration — this may be the best opportunity we’ve ever had to directly influence Medicare policy.
- Department of Health and Human Services, Centers for Medicare & Medicaid Services. 42 CFR Chapter IV. [CMS–9070–P]. RIN 0938–AQ96. Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction. Federal Register Volume 76, Issue 205 (October 24, 2011). <http://www.gpo.gov/fdsys/granule/FR-2011-10-24/2011-27176>
- Executive Order 13563. Improving Regulation and Regulatory Review. Signed: January 18, 2011. Federal Register page and date: 76 FR 3821, January 21, 2011. <http://www.archives.gov/federal-register/executive-orders/2011.html>
- Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events. N Engl J Med 2009;361:1329-1338.
- Personal Communication.
- Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA 2011;305:43-49.
- Medicare National Coverage Determination (NCD) for Implantable Automatic Defibrillators, Section 20.4.
- NCDR® ICD Registry™. <http://www.ncdr.com/webncdr/ICD/Default.aspx>
- “Medicare To Expand Coverage of Implantable Cardioverter Defibrillators Based on Study Results.” California HealthLine. 19 Jan. 2005. <http://www.californiahealthline.org/Articles/2005/1/20/Medicare-To-Expand-Coverage-of-Implantable-Cardioverter-Defibrillators-Based-on-Study-Results.aspx?topic=Health%20Care%20Costs#ixzz1eOfLTf7k>
- Weiss, Rick. “Medicare To Cover Cardiac Device.” Washington Post. 20 Jan. 2005. <http://www.washingtonpost.com/wp-dyn/articles/A22075-2005Jan19.html>