Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers

Dear colleagues,
I am writing to express my strongest possible support for CMS coverage of dual chamber pacemakers. The use of dual chamber pacemakers has been standard practice in the electrophysiology and pacing community for over 30 years. The recent decision to significantly limit the coverage of dual chamber devices is based on limited clinical data and results in unnecessary testing in this typically elderly patient population.

I believe that any reconsideration of the current guidelines should be retroactive for at least 3 years. Thank you for your consideration of my request.

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June 28, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Cardiac Pacemakers Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3)

Dear Dr. Jacques:

The Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) appreciate this opportunity to comment on the proposed decision memo. The societies have been working together with member experts and CMS staff for some time to find the correct way to update this national coverage decision (NCD) in a manner that accounts for advances in technology and current standards of clinical practice.

While we requested modest changes only to the covered indications for dual-chamber pacemakers—a particular area of concern for our members—we view the proposed decision as a significant improvement over the existing coverage indications. Removing the distinctions for covered indications of single- and dual-chamber pacemaker implantation simplifies the coverage structure, removes some ambiguity from existing indications, and provides a degree of certainty to cardiologists who make the decision to employ these therapeutic devices. We support covering both single- and dual-chamber implanted permanent cardiac pacemakers for the identical indications of documented symptomatic bradycardia due to sinus node dysfunction, second-degree atrioventricular (AV) block, and third-degree AV block.

Bradycardia caused by these three indications is not the only instances where implanted permanent pacing is appropriate. Our review of the indications proposed for non-coverage did raise some concerns. Our comparison of the existing coverage to both the new coverage and our requested coverage identified several previously covered indications that are now proposed for non-coverage. We also determined that several indications for which we expressly requested coverage are not addressed. We will focus our comments on those indications as well as several others for which we believe the proposed coverage fails to adequately address the needs of the patients and incorporate the evidence supporting current clinical practices.

Hypersensitive Carotid Sinus Syndrome
A patient with intermittent asystolic episodes caused by hypersensitive carotid sinus syndrome can benefit greatly from a pacemaker if these episodes are associated with substantial symptoms. Current guidelines offer appropriate direction for when pacing is appropriate. We recommend the specific example of hypersensitive carotid sinus syndrome be removed from non-covered indication #14 regarding pacing that takes place intermittently. This recommendation is based on the bulleted guideline recommendations below. Hypersensitive carotid sinus syndrome with syncope due to bradycardia is currently covered under singlechamber indications. We are unaware of evidence to indicate this condition no longer warrants treatment. As such, we also recommend the existing single-chamber indication #11 for these patients be included as a covered indication.

• Permanent pacing is indicated for recurrent syncope caused by spontaneously occurring carotid sinus stimulation and carotid sinus pressure that induces ventricular asystole of more than 3 seconds. (Class I Recommendation, Level of Evidence C) (142, 152)
• Permanent pacing is reasonable for syncope without clear, provocative events and with a hypersensitive cardioinhibitory response of 3 seconds or longer. (Class IIa Recommendation, Level of Evidence C) (142)

Pacing After Acute Myocardial Infarction (AMI) (Temporary Complete and/or Mobitz Type II)
Certain patients who suffer AMI with AV block have unfavorable short- and long-term prognoses. Current guidelines offer appropriate direction for when pacing is appropriate. MS currently covers single-chamber pacing after AMI for patients with certain characteristics. We are unaware of evidence to indicate this condition no longer warrants treatment. As such, we recommend non-covered indication #7 be removed and the existing single-chamber indication #13 for these patients be included as a covered indication. This edit aligns with the below guideline recommendations.

• Permanent ventricular pacing is indicated for persistent second-degree AV block in the His-Purkinje system with alternating bundle-branch block or third-degree AV block within or below the His-Purkinje system after ST-segment elevation MI. (Class I Recommendation, Level of Evidence B) (79, 126-129, 131)
• Permanent ventricular pacing is indicated for transient advanced second- or third-degree infranodal AV block and associated bundle-branch block. If the site of block is uncertain, an electrophysiological study may be necessary. (Class I Recommendation, Level of Evidence B) (126, 127)

Asymptomatic Second- and Third-Degree AV Block
The proposal identifies a number of asymptomatic indications for non-coverage. None of those are specific to third-degree AV block. Asymptomatic second- or third-degree AV block is a condition for which guidelines recommend pacemaker implantation in several situations. Some patients with these conditions will present with symptoms, but others will not. Coverage of asymptomatic heart block should be available for these patients. We recommend a covered indication be added for documented advanced second- degree or third degree block not due to a reversible cause even in the absence of symptoms, as well as second-degree block at an intra or infra HIS level documented on EP testing with or without symptoms. This edit aligns with the below guideline recommendations.

• Permanent pacemaker implantation is indicated for third-degree and advanced second-degree AV block at any anatomic level in awake, symptom-free patients in sinus rhythm, with documented periods of asystole greater than or equal to 3.0 seconds (86) or any escape rate less than 40 bpm, or with an escape rhythm that is below the AV node. (Class I Recommendation, Level of Evidence C) (53, 58)
• Permanent pacemaker implantation is indicated for third-degree and advanced second-degree AV block at any anatomic level in awake, symptom-free patients with AF and bradycardia with 1 or more pauses of at least 5 seconds or longer. (Class I Recommendation, Level of Evidence C)
• Permanent pacemaker implantation is indicated for third-degree and advanced second-degree AV block at any anatomic level after catheter ablation of the AV junction. (Class I Recommendation, Level of Evidence C) (87, 88)
• Permanent pacemaker implantation is indicated for third-degree and advanced second-degree AV block at any anatomic level associated with postoperative AV block that is not expected to resolve after cardiac surgery. (Class I Recommendation, Level of Evidence C) (84, 85, 89, 90)
• Permanent pacemaker implantation is indicated for third-degree and advanced second-degree AV block at any anatomic level associated with neuromuscular diseases with AV block, such as myotonic muscular dystrophy, Kearns-Sayre syndrome, Erb dystrophy (limb-girdle muscular dystrophy), and peroneal muscular atrophy, with or without symptoms. (Class I Recommendation, Level of Evidence B) (91-97)
• Permanent pacemaker implantation is indicated for asymptomatic persistent third-degree AV block at any anatomic site with average awake ventricular rates of 40 bpm or faster if cardiomegaly or LV dysfunction is present or if the site of block is below the AV node. (Class I Recommendation, Level of Evidence B) (76, 78)
• Permanent pacemaker implantation is indicated for second- or third-degree AV block during exercise in the absence of myocardial ischemia. (Class I Recommendation, Level of Evidence C) (81, 82)
• Permanent pacemaker implantation is reasonable for persistent third-degree AV block with an escape rate greater than 40 bpm in asymptomatic adult patients without cardiomegaly. (Class IIa Recommendation, Level of Evidence C) (59, 63, 64, 76, 82, 85)
• Permanent pacemaker implantation is reasonable for asymptomatic second-degree AV block at intra- or infra-His levels found at electrophysiological study. (Class IIa Recommendation, Level of Evidence B) (74, 76, 78)

Pacing to Prevent Tachycardia
Our request for reconsideration included an indication for certain patients with long QT syndrome. That condition is not addressed as part of the proposed coverage. We recommend a covered indication be added for symptomatic or high-risk patients with congenital long QT syndrome. It is supported by our previous submission and the below guideline recommendations.

• Permanent pacing is indicated for sustained pause-dependent VT, with or without QT prolongation. (Class I Recommendation, Level of Evidence C) (188, 189)
• Permanent pacing is reasonable for high-risk patients with congenital long-QT syndrome. (Class IIa Recommendation, Level of Evidence C) (188, 189)

Chronotropic Incompetence
Our request for reconsideration included an indication for select patients with symptomatic chronotropic incompetence. That condition is not addressed as part of the proposed coverage. We recommend a covered indication be added for select patients with symptomatic chronotropic incompetence. This recommendation is based on our previous submission and the bulleted guideline recommendation below.

• Permanent pacemaker implantation is indicated for symptomatic chronotropic incompetence. (Class I recommendation, Level of Evidence C) (53-57)
• After heart transplant permanent pacing is indicated for persistent inappropriate or symptomatic sinus bradycardia not expected to resolve and for other Class I indications for permanent pacing. (Class I, Level of Evidence C)

Hypertrophic Cardiomyopathy
Our request for reconsideration included an indication for select patients with symptomatic hypertrophic cardiomyopathy. That condition is not addressed as part of the proposed coverage. We recommend a covered indication be added for select patients with medically refractory, symptomatic hypertrophic cardiomyopathy with significant or provoked left ventricular outflow obstruction. This recommendation is based on our previous submission and the bulleted guideline recommendation below.

• Permanent pacing may be considered in medically refractory symptomatic patients with HCM and significant resting or provoked LV outflow tract obstruction. (Class IIa Recommendation, Level of Evidence: A) (233, 235, 237, 238, 246, 247)

Reversible Bradycardia
We generally agree with noncovered indication #1. However, this noncovered indication could be construed to include essential drug therapy that causes bradycardia. The below guideline offers a solution for this indication.

• Permanent pacemaker implantation is indicated for symptomatic sinus bradycardia that results from required drug therapy for medical conditions. (Class I Recommendation, Level of Evidence C)

This scenario is currently covered under single-chamber indication #7. We request that indication #7 be carried forward into the updated coverage.

Intermittent Bradycardia
We are concerned that noncovered indication # 14 stating that pacing is not indicated when it is needed only intermittently and briefly could be misconstrued by payers or auditors. Patients with intermittent asystolic episodes still can benefit tremendously from the pacemaker if these episodes are associated with substantial symptoms (such as syncope). Unexplained but profound episodic asystole due to sinus arrest is one example. A patient may only need a pacemaker once in several months, but if there is documented sinus arrest not due to a reversible cause, and not due to an explainable and correctable cause, a pacemaker can have a substantial impact on eliminating syncope and other symptoms due to this problem. Such use is brief and intermittent in one sense, but would continue as these patients have a reasonable likelihood of needing pacing briefly and intermittently over a long period of time. We recommend the indication be revised to say, “A clinical condition in which pacing takes place only intermittently and briefly, except for indications that require brief and intermittent pacing over a prolonged period of time, e.g, episodic asystole due to sinus arrest.”

Contractor Coverage
In the event you do not find these recommendations adequate to revise the NCD covering these specific indications, we suggest that it would be appropriate to leave coverage of hypersensitive carotid sinus syndrome, pacing after AMI, asymptomatic second- and third-degree AV block, prevention of tachycardia, chronotropic incompetence, and/or hypertrophic cardiomyopathy for contractors to determine.

Thank you for your careful consideration of these comments and your continued work on this complex issue. We believe incorporation of these revisions will allow greater harmonization between current clinical guidelines on pacing and coverage. We are including the guideline and a bibliography of the literature supporting the guideline recommendations for your review. Please contact James Vavricek, Senior Specialist in Regulatory Affairs for ACC, at jvavricek@acc.org or Kim Moore, Director of Reimbursement and Regulatory Affairs for HRS, at kmoore@hrsonline.org if you have questions or need additional information.

Sincerely,

/s/
Hugh Calkins, MD, FHRS
HRS President

/s/
John Gordon Harold, MD, MACC, MACP, FESC, FCCP, FAHA
ACC President

Bibliography

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Submitted Electronically

June 28th, 2013

Joseph Chin, MD, MS
Medical Officer
Centers for Medicare and Medicaid Services
PO Box 8011
Baltimore, Maryland 21244-1850

RE: Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (3rd Reconsideration); CAG-00063R3

Dear Dr. Chin:

St. Jude Medical appreciates the opportunity to comment on the proposed decision memo for single- and dualchamber permanent cardiac pacemakers. St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. Our company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient.

Overall, we are very pleased with the changes that CMS has proposed in this decision memo. We commend CMS, the Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) for their collaboration regarding updating the existing national coverage determination to more closely reflect current clinical practice based on the best clinical evidence available. While we are in general agreement with the decision memo, there are several points where we would like to provide comments, and are listed below.

Category B IDE Clinical Trial Coverage

The existing NCD for Cardiac Pacemakers (20.8) includes language for both single- and dual-chamber pacemakers that provides coverage for non-covered indications when evaluated in Category B IDE clinical trials, or as routine costs of single/dual-chamber cardiac pacing associated with clinical trials, in accordance with section 310.1 of the NCD manual. The draft decision memo does not include this language. We recommend that CMS include this language in the draft decision memo. It is unclear in the draft decision memo how coverage of IDE clinical trials for pacemakers will be handled. We believe that adding the IDE coverage language from the existing NCD to the decision memo provides clarity regarding IDE clinical trials and is consistent with CMS policy on IDE trial coverage.

Non-Covered Indications

In the draft decision memo under non-covered indications for both single- and dual-chamber pacemakers, CMS lists the following: 14. A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures (emphasis added).

We suggest removing this example from this non-covered indication. The existing NCD does provide coverage for this indication under nationally covered indications for single-chamber pacemakers (#11). More importantly, the HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection rates the evidence as “Class IIa” for single- or dual-chamber ventricular pacing for patients with hypersensitive carotid sinus syndrome.

Covered Indications

The overall covered indications in the draft decision memo are simplified compared to the conditions covered in the existing NCD. While we believe overall this simplification is warranted, we have some concern that certain covered conditions listed in the existing NCD are not clear under the new decision memo. For example, the existing NCD provides coverage for second-degree AV heart block of Type I with the QRS complexes prolonged (#15). The proposed decision memo covers symptomatic bradycardia due to second degree and/or third degree AV block. We believe there may be some confusion regarding coverage this indication, and suggest that CMS provide additional clarity in the body of the decision memo regarding any coverage status changes of conditions listed in the existing NCD compared to the proposed decision memo. This additional clarity will provide guidance to physicians, providers and MACs as they evaluate clinical decision making.

CMS Analysis

The proposed decision memo appears to indicate single and dual-chamber pacemakers without preference. This policy implies that physician expertise, patient symptoms and clinical evidence will dictate the appropriate therapy decisions for each patient. We agree with this approach, and appreciate the simplicity of the proposed coverage policy. However, in the CMS Analysis section of the decision memo, CMS states that dual chamber pacemakers are neither superior nor inferior to single chamber pacemakers due to SND or advanced AVB. We disagree with the statement regarding the effectiveness of single and dual chamber devices. Clinical evidence is available that demonstrates the benefits by device type depending on clinical indications. The Consensus Statement provides recommendations based on the clinical evidence, and does call out where dual chamber pacing is recommended (i.e. atrial pacing in patients with SND, patients with AV block, etc.) as well as when single chamber pacing is recommended (e.g. single chamber ventricular pacing is recommended as an acceptable alternative to dual chamber pacing in patients with AV block who have specific clinical situations that limit the benefits of dual-chambered pacing). We believe this statement by CMS provides confusion and ambiguity for providers and MACs going forward, and should be eliminated from the decision memo.

Additionally, CMS states that physicians need to carefully document in the medical record why a dual-chambered pacemaker was chosen. We agree that the medical record should appropriately document the rationale for the clinical decision making. However, the proposed decision memo provides limited guidance in terms of the types of documentation CMS would expect to appear in the medical record to justify the device selection process. We suggest that CMS provide more details and examples of the types of information to be included in the medical record. This will help inform physicians, providers and MACs regarding the information that should be incorporated into the medical record, and will hopefully facilitate easier medical reviews going forward.

CMS also states that physicians need to inform patients of higher complication rates. We suggest that CMS revise this language that physicians need to inform patients of the benefits and risks of pacing therapy, the differences between single and dual chamber pacing, the potential benefits and risks associated with each device type and explain their rationale for their clinical recommendation. The current statement in the decision memo focuses only on complications of dual chamber pacing, and we suggest that the patient should be informed regarding the multiple factors that go into recommending one type of device over another. It may also be inferred from reading this paragraph in the decision memo that informing the patient must be documented in the medical record. If this is the intent, we believe this to be unnecessary documentation in that the medical record will already include the clinical rationale for the device type chosen. We suggest that CMS clarify this in the decision memo.

Again, we want to commend CMS for reopening the pacemaker NCD, and for collaborating with the HRS and ACC in drafting this decision memo to more accurately reflect the clinical evidence available and current clinical practice. We also appreciate the opportunity to provide our comments on the proposed decision memo. If you have any questions or require additional information regarding these comments, please do not hesitate to contact me directly at (651) 756-6003 or at mdomyahn@sjm.com .

Sincerely,

Mark Domyahn
Senior Director, Global Healthcare Economics

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On behalf of Medtronic, Inc., I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for public comment on the proposed decision memo for cardiac pacemakers in the context of single-chamber and dual-chamber permanent cardiac pacemakers¹. Medtronic is one of the world’s leading medical technology companies, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. Medtronic’s history is deeply rooted in the development of pacemaker therapy and we appreciate the opportunity to comment on the proposed decision memo.

Medtronic supports CMS’ reconsideration of the Cardiac Pacemaker Policy and appreciates the thoughtful review of evidence. The evidence base for single- and dual-chamber pacemakers has increased considerably since the last substantive revision of the policy in 1985. Through this reconsideration, CMS recognizes the importance of ensuring that coverage policies remain current with the evidence base, clinical practice, and professional society guidelines.

Medtronic also appreciates CMS’ efforts to simplify the national coverage determination (NCD). In general, we find that the proposed coverage policy is consistent with the HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection, and we support this approach. Nevertheless, we have specific comments on aspects of the proposed policy. In some instances, we believe the language in the proposed decision memo should be more specific, and in other circumstances, we believe language from the previous NCD should be restored in the final decision.

It is our hope that the recommendations below will ensure greater clarity and allow for more consistent coverage policy interpretations by Medicare Administrative Contractors (MACs), Comprehensive Error Rate Testing (CERT), and providers. In addition, our recommendations seek to ensure that simplification of the policy does not unduly impact a physician’s selection of clinically appropriate therapy or patient access to necessary care.

We recommend that CMS implement the following changes in the final NCD:

• Restore language explicitly covering cardiac pacemakers in Category B Investigational Device Exemption (IDE) clinical trials.
• Include hypersensitive carotid sinus syndrome as a covered indication for cardiac pacing, which is aligned with the original NCD and recommended in the HRS/ACCF Expert Consensus Statement.
• Reconsider language around justifying the therapeutic choice and documentation of pacemakers.
• Clarify specific language in the draft decision memo.

Restore language explicitly covering cardiac pacemakers in Category B IDE clinical trials.

The draft decision memo would remove language that explicitly provides coverage for pacemaker therapy in Category B IDE clinical trials. We believe this change could adversely impact ongoing and future clinical trials that will offer critical information to CMS, the medical community, and patients regarding pacemaker therapy. To ensure continued beneficiary access to these trials and further the evidence base regarding pacemaker therapy, Medtronic recommends that explicit language permitting coverage of cardiac pacemakers in Category B IDE clinical trials be restored in the final version of the NCD.

In 2003, CMS recognized the potential harm of removing similar language from the implantable cardioverter defibrillators (ICD) policy during the reconsideration of that NCD. Acknowledging that the exclusion of explicit coverage for IDE trials “might have significantly impacted clinical trials,”² CMS at that time reopened the ICD NCD and revised it to include language permitting coverage of ICDs in Category B IDE clinical trials. In light of the potential for similar unintended consequences to existing and future cardiac pacemaker Category B IDE clinical trials, Medtronic recommends the language that explicitly provides coverage for pacemaker therapy in Category B IDE clinical trials be restored in the final NCD.

Include hypersensitive carotid sinus syndrome as a covered indication for cardiac pacing, which is aligned with the original NCD and recommended in the HRS/ACCF Expert Consensus Statement.

While Medtronic appreciates the Agency’s efforts to streamline the coverage policy for cardiac pacemakers in the proposed decision memo, we believe a certain level of specification should remain to ensure that the NCD revision does not remove existing coverage for important pacing indications. For instance, the proposed decision memo reclassifies the hypersensitive carotid sinus syndrome indication for pacing as non-covered. This reclassification is concerning given that hypersensitive carotid sinus syndrome is covered under the existing and prior NCDs (i.e. Section 20.8³ and 65-6⁴ of the NCD Manual, respectively), and the 2012 HRS/ACCF Expert Consensus Statement supports cardiac pacing for hypersensitive carotid sinus syndrome⁵. The HRS/ACCF Expert Consensus Statement concludes that “dual-chamber or single-chamber ventricular pacing can be useful for patients with hypersensitive carotid sinus syndrome” (Class IIa recommendation).⁶

The proposed decision memo does not offer any insight into the reason why this change may have occurred. Because of this, Medtronic believes that CMS may have inadvertently omitted this coverage as it streamlined the policy.

Given the limited clarity offered surrounding this change, the fact that the HRS/ACCF Expert Consensus Statement supports this indication, and that coverage was previously provided, Medtronic recommends that CMS reinstate coverage of cardiac pacing for “patients with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures."⁷

Reconsider language around justifying the therapeutic choice and documentation of pacemakers.

Medtronic requests that CMS reconsider statements in the draft decision regarding the justification of the need for dual-chamber pacemakers in the medical record. Medtronic fully supports documenting the medical necessity of pacemaker use and the decision making process of the patient and physician. However, we believe some of the language in the draft decision could be improved to more directly reflect the evidence that prompted this decision update. The language reads as follows:

We are concerned that the language above leaves room for interpretation that could lead to inappropriate scrutiny by auditors regarding the choice between dual and single chamber pacing. We believe this choice should remain between the physician and patient since guidelines state the following: “The judgment that such a pacemaker is warranted in the patient meeting accepted criteria must be based upon the individual needs and characteristics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.”^8,9

In order to better achieve this aim, we offer a suggestion for a change in this language that better reflects the original intent of opening this coverage decision:

To be specific, provider documentation in the medical record that the patient has sinus node disease or AV block should be sufficient to support the use of either single or dual chamber pacing. We also believe the review of the risks and benefits with the patient should be integral to the informed consent.

Medtronic seeks clarification of additional language in the draft decision memo.

The changes from the current NCD (20.8) to the draft decision memo bring simplicity and clarity to the decision summary and are a clear improvement. However, with the consolidation of the covered indications for single- and dual-chamber pacemakers, we believe important details were removed. In order to prevent local Medicare contractors or CERT auditors from interpreting certain language differently, we encourage CMS to provide additional clarity in the final decision memo.

Below we identify the areas where additional clarification is warranted.

As a point of reference from the proposed decision memo for cardiac pacemakers:

Current NCD Covered Indication: “Sinus bradycardia is the consequence of long-term necessary drug treatment for which there is no acceptable alternative when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion). The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.”

• This could be interpreted as covered under the new draft NCD decision summary under “Covered Indication 1” if "necessary," or could be interpreted as non-covered under “Non-Covered Indication 1” if due to "Reversible causes…such as…medications or drugs." Since the previous description describes the drug treatment as “long-term necessary,” it may be hard to also describe it as “reversible.”
• To add clarity we advise adding an explanation in the decision memo that “necessary, long-term” drug treatment is not considered reversible and is covered.

Current NCD Covered Indication: “Sinus node dysfunction with or without symptoms when there are potentially life-threatening ventricular arrhythmias or tachycardia secondary to the bradycardia (e.g., numerous premature ventricular contractions, couplets, runs of premature ventricular contractions, or ventricular tachycardia).”

• This appears to be covered under the new draft NCD decision summary under “Covered Indication 1” in the case where there are symptoms. It would appear that this is not specifically addressed by covered or non-covered indications if there are no symptoms (the original coverage decision did not make a distinction about symptoms).
• To add clarity we advise adding an explanation in the decision memo that this would be covered if there are symptoms, and not covered in the absence of symptoms

Previous NCD Covered Indication: “Bifascicular or trifascicular block accompanied by syncope which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded.”

• This appears to be covered under the new draft NCD decision summary under “Covered Indication 2,” however the word “transient” could cause confusion in the interpretation, especially if it is confused with the term “reversible.”
• To add clarity we advise adding an explanation in the decision memo that this indication is covered.

Previous NCD Covered Indication: “In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing" (pacing above the basal rate) to prevent ventricular tachycardia.”

• This is not specifically covered in the new draft NCD decision summary. However, coverage seems to be implied by the exception in “Non-Covered indication 13” (“Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of the tachycardia”).
• To add clarity we advise adding an explanation in the decision memo that this indication is covered.

Previous NCD Covered Indication: “Second-degree AV heart block of Type I with the QRS complexes prolonged.”

• This is not specifically covered in the new draft NCD decision summary. However, coverage seems to be implied by the exception in “Non-Covered Indication 6” (“Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle (a component of the electrical conduction system of the heart”).
• To add clarity we advise adding an explanation in the decision memo that this indication is covered when QRS complexes are prolonged.

Conclusion

In summary, Medtronic largely supports CMS’ proposed revisions to the pacemaker national coverage decision, as it reflects current practice and the body of evidence with regard to dual- versus single-chamber device selection. However, Medtronic requests that CMS take into consideration our recommendations as it finalizes the decision memo. We believe our comments reflect the requested clarification physicians will require maintaining flexibility in the appropriate mode selection for patients.

Medtronic appreciates this opportunity to provide comments to CMS on this reconsideration of the NCD on cardiac pacemakers for single- and double-chamber pacemakers. We appreciate your consideration and are happy to provide further information or assist with any additional questions. Please feel free to contact me at barbara.kay.veath@medtronic.com should you have any questions or wish to discuss our comments in further detail.

Sincerely,

/s/
Barbara Veath
Director, Global Health Economics and Health Policy
Medtronic, Inc.

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1 CMS. "Proposed Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers." May 2013
2 CMS. "Decision Memo for Implantable Defibrillators - Clinical Trials (CAG-00157R)." March 2004
3 NCD for Cardiac Pacemakers (NCD Manual Section Number 20.8) Effective Date of Version: 4/30/2004
4 NCD for Cardiac Pacemakers (NCD Manual Section Number 65-6) Effective Date of Version: 5/9/1985
5 Heart Rhythm Society, the American College of Cardiology Foundation, and the Society of Thoracic Surgeons. "HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection." Heart Rhythm (August 2012): Vol. 9. No. 8. Page 1346
6 Heart Rhythm Society, the American College of Cardiology Foundation, and the Society of Thoracic Surgeons. "HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection." Heart Rhythm (August 2012): Vol. 9. No. 8. Page 1346
7 NCD for Cardiac Pacemakers (NCD Manual Section Number 20.8) Effective Date of Version: 4/30/2004
8 Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). J Am Coll Cardiol 2008;51:e1- 62.
9 Vardas PE, Auricchio A, Blanc JJ, et al. Guidelines for cardiac pacing and cardiac resynchronization therapy: the task force for cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Eur Heart J 2007;28:2256 -95.
10 CMS. "Proposed Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers." May 2013

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June 27, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Dept. of Health and Human Services
Attn: CMS-1589-FC
Room 455-G, Hubert H. Humphrey Bldg.
200 Independence Ave., S.W.
Washington, DC 20201

Re: Proposed Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3)

Dear Dr. Jacques;

Boston Scientific Corporation appreciates the opportunity to comment in response to Medicare’s proposed decision memo to update the national coverage determination for cardiac pacemakers: single-chamber and dual-chamber cardiac pacemakers (CAG-00063R3).

As the world’s largest company dedicated to developing, manufacturing, and marketing of less-invasive therapies, Boston Scientific supplies medical devices and technologies that are used by the following medical specialty areas, all of which provide Medicare beneficiary care.

• Cardiac Rhythm Management
• Gastroenterology
• Interventional Bronchoscopy
• Interventional Cardiology
• Interventional Radiology
• Oncology
• Pain Management
• Urology, and
• Women’s Health

Boston Scientific is pleased that Medicare has reviewed the existing National Coverage Determination (NCD) for Cardiac Pacemakers (Section 20.8 of the coverage manual). In response to the proposed changes we would like to make the following recommendations.

Coverage of Pacing Therapy for Patients with Hypersensitive Carotid Sinus Syndrome
Number 14 of the proposed non-covered indications describes “A clinical indication in which pacing takes place only intermittently and briefly…” The example provided describes, “the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.”

BSC Comment
We disagree with the proposed non-coverage of pacemakers for patients with hypersensitive carotid sinus syndrome who are syncopal due to bradycardia and unresponsive to other prophylactic measures. The HRS/ACCF Consensus Statement on Pacemaker Device and Mode Selection , considers pacemakers to be a Class IIa recommendation for such patients. In the absence of alternative therapies, these patients can benefit from pacing therapy and therefore pacing therapy should be covered for such patients. We note that pacing therapy is currently covered for such patients.

BSC Recommendation
Indication number 14 should be removed from the proposed NCD non-covered list. We request CMS retain this clinical indication as a covered indication.

Coverage for Category B Investigational Devices used as part of a Clinical Trial (IDE)
The language specific to coverage for Category B Investigational Device Exemptions (IDE) clinical trials has been removed. It is explicitly covered in the current NCD.

BSC Comment
This language should not be deleted and we urge CMS to reinsert it back into the NCD.

BSC Recommendation
We request the following statement be added back into the proposed NCD to avoid any potential confusion on the part of the MACs.

“All other indications for single or dual-chamber cardiac pacing for which CMS has not specifically indicated coverage remain nationally noncovered, except for Category B IDE clinical trials, or as routine costs of single or dual-chamber cardiac pacing associated with clinical trials, in accordance with Section 310.1 of the NCD Manual.”

Coverage for Sick Sinus Syndrome Patients with Symptomatic Chronotropic Incompetence
CMS has defined symptomatic bradycardia as “directly attributable to a heart rate of less than 60 beats per minute…”

BSC Comment
We are concerned that without additional clarification, limiting sinus bradycardia to heart rates of less than 60 beats per minutes may exclude patients who are chronotropically incompetent and experience bradycardia symptoms at heart rates above 60. A patient with chronotropic incompetence may have a heart rate greater than 60; however, the patient may not be able to achieve heart rates that can support certain levels of physical activity (i.e., carrying groceries or climbing a flight of stairs) and thus are bradycardic for such levels of activity. In many cases, patients with chronotropic incompetence require rate responsive pacing. Symptomatic chronotropic incompetence is considered a Class I recommendation for permanent pacing per ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities . Under the proposed NCD, it is not clear if pacing therapy would be covered for patients with chronotropic incompetence.

BSC Recommendation

We request that CMS add clarifying language to the definition of symptoms of bradycardia to include patients with documented symptomatic chronotropic incompetence, irrespective of whether the patient's minimum heart rate is above or below 60.

Thank you for the opportunity to comment on the proposed decision memo for single-chamber and dual-chamber cardiac pacemakers. Please feel free to contact me at (508) 652-7492 or e-mail parashar.patel@bsci.com or contact Kristen Hedstrom, MPH, Director of Health Policy and Payment, at (202) 637-8021 or e-mail Kristen.hedstrom@bsci.com if you have any questions.

Sincerely,

Parashar B. Patel
Vice President, Health Economics and Reimbursement
Boston Scientific Corporation

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June 25, 2013

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00063R3

Dear Sir/Madam:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for single-chamber and dual-chamber permanent cardiac pacemakers.

According to the proposed decision memo, CMS intends to combine the covered indications for single- and dual-chamber pacemakers and would no longer distinguish between the two. Medicare would cover both single- and dual-chamber permanent cardiac pacemakers for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. AHA appreciates the Agency's attempt to simplify the coverage policy for these devices and we agree that Medicare should cover the two indications CMS has proposed. We are, however, concerned that the proposed policy does not completely align with current clinical guidelines and fails to provide coverage for several important indications.

First, we are concerned that the proposed policy would eliminate Medicare coverage for two indications that are currently covered under the existing policy. According to the proposed policy, Medicare coverage would no longer be provided for:

• Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (third degree) and/or Mobitz Type II second degree atrioventricular block in association with bundle branch block (Proposed Noncovered Indication #7).
• A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures (Proposed Noncovered Indication #14).

AHA strongly disagrees with this proposed change; pacing is an appropriate treatment option for both of the above indications. In addition, patients who experience an acute myocardial infarction with an atrioventricular block and patients with hypersensitive carotid sinus syndrome are both currently listed as covered indications in the existing coverage policy (Single-Chamber Covered Indications #13 and #11 respectively). We are unaware of any reason why the coverage status for these two indications should be changed. We therefore request that CMS continue to provide coverage and include both as covered indications in the proposed policy.

Second, we are also concerned that the proposed policy does not address several indications that are currently listed as covered in the existing policy. These indications include:

• Sinus bradycardia is the consequence of long-term necessary drug treatment for which there is no acceptable alternative when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion). The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause (Existing Single-Chamber Covered Indication #7).
• Bifascicular or trifascicular block accompanied by syncope which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded (Existing Single-Chamber Covered Indication #12).
• In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing" (pacing above the basal rate) to prevent ventricular tachycardia (Existing Single-Chamber Covered Indication #14).

It is unclear if these indications would be covered under the proposed policy. They are not specifically listed as covered indications and they do not appear to qualify for coverage under either of the two covered indications proposed by CMS (symptomatic bradycardia due to sinus node dysfunction or second- or third-degree atrioventricular block). Yet, they are not specifically listed as noncovered indications either. We request that CMS clarify the status of these indications and include all three as covered indications in the revised coverage policy. As noted above, all three are currently covered by Medicare and we are unaware of any evidence that warrants a change in the coverage policy for these indications.

Third, CMS decided to open this National Coverage Analysis after receiving a request from the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) to update the indications for dual-chamber pacemakers. ACC and HRS provided CMS with specific recommendations for revising the clinical indications. In a February 22, 2013 letter to the Agency, AHA offered our support for the ACC/HRS request noting that the recommendations align with the HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection and the 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities.

We are concerned that a number of the ACC/HRS recommendations are not included in the revised policy proposed by CMS. These include:

• Patients who have documented pacemaker syndrome (e.g., symptoms with retrograde conduction including, but not limited to significant drop in blood pressure, chest discomfort, fullness in neck, shortness of breath, lightheadedness, pre-syncope or syncope, dyspnea on exertion, fatigue, nausea, etc.) or anticipated pacemaker syndrome (e.g., young active patient, etc.) (ACC/HRS Double-Chamber Covered Indication #1) (Level of Evidence B; Class I Recommendation).
• Patients with symptomatic chronotropic incompetence (e.g. exertional fatigue, exertional dyspnea, exertional lightheadedness and/or inability to reach age specific maximal heart rate) (ACC/HRS Double-Chamber Covered Indication #2) (Level of Evidence C; Class IIa Recommendation).
• Selected symptomatic or high-risk patients with congenital long QT syndrome (ACC/HRS Double-Chamber Covered Indication #6) (Level of Evidence C; Class I Recommendation).
• Selected patients with medically refractory, symptomatic hypertrophic cardiomyopathy with significant or provoked left ventricular outflow obstruction (e.g. symptoms including shortness of breath, chest pain, dyspnea on exertion, lightheadedness, orthopnea, paroxysmal nocturnal dyspnea, pre-syncope or syncope, etc.) (ACC/HRS Double-Chamber Covered Indication #7) (Level of Evidence C; Class IIa Recommendation).

As with the section above, these indications are not specifically included in the lists of covered and noncovered indications; therefore, their coverage status remains unclear. Yet it appears that they would not be covered under the proposed policy. We request that CMS clarify their coverage status and include these as covered indications. Coverage for these indications is supported by the guidelines referenced above and in the literature previously provided by ACC and HRS.

Finally, we request that CMS correct two errors before releasing the final decision memo and coverage policy. The coverage policy currently refers to "P-R intervals". As we noted in our previous letter to the Agency, this should be corrected to read "R-R intervals".

In addition, the proposed decision memo contains a list of acronyms and corresponding full terminology. The acronym "AHA" is listed as standing for the "American Hospital Association". While the American Hospital Association and the American Heart Association share the "AHA" acronym, all of the references to "AHA" in the decision memo appear to discuss guidelines released by the American Heart Association. We request that CMS correct the acronym list to indicate that "AHA" stands for the American Heart Association.

In closing, we reiterate our appreciation of the Agency's efforts to simplify the coverage policy for permanent cardiac pacemakers. We agree that Medicare should provide coverage for patients with symptomatic bradycardia due to sinus node dysfunction or second- or third-degree atrioventricular block. However, we have serious concerns that the proposed policy would no longer provide coverage for several important clinical indications. We urge CMS to revisit the coverage policy and ensure that the revised policy continues to cover all of the indications currently covered in the existing policy. We also request that CMS include the clinical indications originally recommended by ACC/HRS and supported by AHA in the revised coverage policy.

Thank you for consideration of our comments.

Sincerely,

/s/
Donna K. Arnett, PhD
President, American Heart Association

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I applaud your decision to cover Dual Chamber Pacemakers for all pacemaker indications. I am concerned that the auditors will deny the dual chamber pacemakers placed before your decision.

Please make this decision retroactive to at least 3 years so that CMS contractors can't deny dual chamber pacemakers, no matter when they are implanted. It would be unjust to not allow coverage for all dual chamber pacemakers.
Thank you for your consideration.
Nancy Nicholson, RN
Director of Case Management

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Thank you for this update, but there's an unclear area. You state there is coverage for SYMPTOMATIC bradycardia due to second degree and/or third degree AV block. You say there is NO coverage for ASYMPTOMATIC second degree Mobitz I (Wenckebach), but what you don't address is asymptomatic Mobitz II or Complete Heart Block. This is not infrequently picked up on 24 hr monitoring OR while the patient is in the hospital. A pt with RBBB plus LAD or LBBB with intermittent CHB is at GREAT risk. Please comment. Referring physicians are rightly concerned about these pts not receiving a device. Thank you. R. Wittum, MD, MS, FACC, FSCAI

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We were happy to learn that CMS has recognized the importance of dual-chamber pacemakers as opposed to just single-chamber ventricular devices in many of our patients. Dual-chamber pacing is especially important in ALL PATIENTS with sinus node dysfunction, sick sinus syndrome and many patients with any form of brady-tachy syndrome. In addition, many patients who are in sinus rhythm and develop heart block indications for pacer should receive a dual chamber device, especially if there is ANY indication that the patient may develop PACEMAKER SYNDROME because of the later loss of AV synchrony. We hope that this realization and acceptance by CMS reviewers will also apply to retrospective reviews over the last 3 years.

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I am the President of the Adventist Health Policy Association, representing 80 hospitals in 20 states. AHPA supports the position taken by CMS on Singel-Chamber and Dual-Chamber Permanent Cardiac Pacemakers. On behalf of our membership, I would urge that CMS make it clear that this decision would apply retroactively. As the data is now conclusive that the procedures are clinically justified and warranted, CMS should preclude the potential of reach back reviews which would seek to invalidate the payment for these services provided prior to CMS' determination. Such a reach back would serve no purpose and be inconsitent with the clinical findings being cited.

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Having worked in cardiac services for up to 20 years, the decision to make the coverage decision cover dual chamber pacemakers for all pacemaker indications meets the current standard of care. I would support the addition of making this decision retroactive so that the auditors cannot continue for the next 3 years to deny dual chamber pacemakers that were placed prior to the implementation date. If the standard of care is for dual chamber pacemakers why would we continue to place single chamber pacemakers for the next 3 years and negatively impact the outcome for current recipients.

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As the director of electrophysiology at St. Thomas Hospital in Nashville, I strongly support the action of CMS to provide coverage for dual chamber pacemakers as described recently. The use of dual chamber pacemakers has been considered the standard of care in this community even before I arrived in 1994 based on clinic trials and physician experience. Many patients will benefit from the clarification of this policy. I request that this policy be applied retroactively for at least 3 years to prevent unnecessary denials of previous implants.

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I applaud the decision to cover dual chamber pacers for all pacer indications on par with single chamber devices. Dual chamber pacers have been the standard of care for many years.

Please make the decision retroactive for at least 3 years so doctors do not get penalized for practicing good medicine and using dual chamber devices.

I have been an electrophysiologist for 15 years and think this decision to allow dual chamber pacing for all indications for which implanters deem appropriate and necessary (rather than single chamber) is right on! Thank you.

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If, as has been stated, "the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block," then it also should be concluded that this was reasonable and necessary when these were implanted over the past few years. We request that CMS make this ruling retroactive at least for 3 years so that the appropriate care provided by hospitals for these recipients is compensated and not denied.

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Thank you for the opportunity to comment on CMS' recent decision to cover dual chamber pacemakers, which have been the standard of care for many years. While I am very happy with this new policy, I am concerned about the previous cases of dual chamber pacemakers which were implanted prior to this new policy, and are therefore subject to ongoing scrutiny and/or audit.

The purpose of my comments is to request that the policy that has recently been espoused be retroactive so that all dual chamber pacemakers which have been implanted within the past few years will not be subject to audits. Since CMS has now determined that dual chamber pacemakers will be covered, it seems unfair that auditors should have the ability to continue to deny such procedures merely because they were implanted before the date of the new policy. If a denial occurs on solely timing and administrative grounds, then this is unfortunate and inappropriate. Please amend the policy to make it retroactive, which would save hospitals time and money in combating denials which CMS now says would be inappropriate. Thank you.

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Greetings,

Pursuant to Proposed Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) the following comment is respctfully submitted.

Whereas CMS has recently published their final decision granting indications for dual-chamber pacemaker utilization and placement on equal parity with single-chamber devices, it is hereby suggested that these indications be used for the purposes of meeting medical not only going forward, but also retrospectively for a period of 3 years. This suggestion to make the current decision retrospective to dual-chamber procedures performed within the past three years will eliminate the cost and administrative burden of defending on appeal denials from auditors based on obsolete guidelines.

Respectfully,

Keith R. Knuth, MD, MBA, FACS

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It makes logical sense that both single and dual chamber pacemakers for all pacemaker indications be approved. Dual chamber pacemakers have always been the standard of care. Additionally, this decision should be retroactive for AT LEAST three years. The denial of coverage for dual chamber pacemakers results in unreasonable workload for doctors and hospitals who are trying to do what's best for our patients. Patients with indications for a pacemaker should receive the dual chamber device. It is a waste of resources, money, and time to deny dual chamber pacemaker claims. Our hospital compliance departments are spending countless hours to justify claims that should not have been denied in the first place.

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