Electrical Bioimpedance for Cardiac Output Monitoring

To Whom It may Concern:
I was disappointed and concerned to read CMS proposed policy on the national reconsideration of Impedance Cardiography (ICG) for hypertension coverage. I have been a practicing cardiologist for the past 25 years, and currently am the Director of The Valley Hospital Heart Failure program in Ridgewood, New Jersey. In my career, I have used numerous emerging technologies. I have utilized ICG in my practice for over 8 years in the diagnosis and treatment of congestive heart failure, hypertensive, and dyspneic patients. ICG, in my opinion, has proven very valuable in the treatment of these patients due to the accuracy, reproducibility, therapeutic and monitoring value of the measurements.

In the last three years, two randomized controlled clinical trials were presented and published in the area of hypertension alone. The most recent randomized controlled clinical trial of ICG in hypertension was published in March 2006 in the American Heart Association’s journal, Hypertension, and enrolled patients on one to three drugs whose blood pressure was not controlled. The study demonstrated statistically significant results: an 8mm Hg systolic (p<0.01) and 7mm Hg diastolic (p<0.001) greater reductions in achieving <140/90 blood pressure control in the ICG arm as compared to the standard care arm.

In my opinion, and the opinion of a number of cardiologists who made comments to CMS during its March comment period, CMS consider the recent clinical data and expand its ICG coverage policy to hypertensive patients not responding to two or more antihypertensive medications. Moreover, to ensure uniform access for providers and beneficiaries, national coverage is necessary. I practice in New Jersey whereby our local carrier, Empire, does not allow coverage of hypertension, although many medical providers have contacted Empire’s medical directors over the last few years regarding the clinical evidence and value of ICG. Thank you for time and attention to this matter.

Sincerely,
John E. Strobeck, MD, PhD, FACC

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September 23, 2006
CMS: This is a comment based on the recent CMS proposal regarding coverage of TEB for patients with hypertension. The proposed CMS coverage decision is no change from the existing coverage determination despite new clinical evidence. It allows each individual carrier to decide whether they will cover for drug-resistant hypertension. In New York, that means noncoverage as Empire, our CMS-contracted local carrier, does not recognize any role for TEB in any patient for control of hypertension. This is clearly inconsistent with the evidence, including the two RCTs (the Mayo Clinic study and the more recent CONTROL trial) that demonstrate a statistically significant lowered BP with TEB-guided therapy as compared to standard care. There are plenty of physicians who have reported similar benefits to the studies so there should be no concern on applicability in real clinical practice.

CMS should not allow the various carriers like Empire to have discretion over coverage of TEB for hypertension. When adequate, high quality, published clinical evidence exists, CMS needs to make a policy that applies to all carriers. The evidence would support national coverage for patients who are not controlled on two or more medications.

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CMS - I have reviewed CMS draft decision for ICG and the available data in CONTROl and Mayo clinic studies. From an evidence-based medicine perspective, there is sufficent data from RCTs to conclude that availability of ICG data leads to lower blood pressures. Lowering blood pressures is a proven positive outcome and has been shown to reduce strokes, myocardial infarcts and CHF. I realized CMS has to balance expenditures with coverage but ICG can help us all in cost-effectively treating HTN patients and prevent prgression to more costly diseases. Possibly you could consider a policy for patients unresponsive to lifestyle changes and two drugs. Having a threshold of three or more drugs, including a diuretic is too high to fully benefit from ICG in the treatment of hypertensive patients.

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I have used ICG to help management of patients with difficult to control hypertension. I have found it very useful. I am a nephrologist who has practiced for 5 years. I have evaluated many patients with hypertension and have suffered consequences of uncontrolled hypertension. I believe ICG is a valuable tool and should be used on uncontrolled hypertensive patients prior to them developing the additional consequences, including damage to their renal system. Based on the Control and Mayo studies I think a reasonable policy should include coverage for all patients who are uncontrolled on two antihypertensive medications. This will provide moderate coverage and help prevent the progression additional morbidities and assocaited expenses.

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I am writing to support an expanded national coverage policy for use of impedance cardiography (ICG) in hypertensive patients that are not at goal BP on 2 or more agents. CMS draft decision for ICG hypertension coverage is not in line with the available clinical evidence from 2 randomized studies for ICG in hypertension. There have been hundreds of comments from physicians (and I am sure many more that have not commented) that have had positive clinical results with ICG on their patients. Due to carrier discretion in NY, our practice can not use ICG for medicare patients with hypertension which is unfair and not in line with the available clinical evidence. Please make a final policy that is fair and has national coverage for an effective device which truly helps us in our patient care.

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I am writing to voice strong opposition to your draft policy for ICG use in hypertensive patients. Many of your decisions for coverage have not had the level of evidence ICG has application in HTN. Not one, but two, RTCs has proven that availbility of ICG data to the provider results in lower BP. These are well designed trials that have statistically significant results that will lead to decreased morbidity and mortality in HTN pts. I practice in New York and our contractor discretion has been to the detriment of our beneficiaries. I implore CMS to create a final policy that allows national coverage for all medicare beenficiaries that cannot be controlled on less than three medications.

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Bioimpedance is important to our medical care for our hypertensive and other cardiac patients. NY state medicare carriers has prohibited coverage of bioimpednace for HTN care. Our Medicare pts are not getting the same level of care as those on provate insurance or those beneficiaries in other states. Your anaylsis conslcudes there is insufficient evidence for expansion of coverage. I submit to you that there is now a second randomized controlled trial supporting the results of the first randomized trial and certainly the results of the second trial would support expansion to national coverage for patients not at goal BP on less than 3 drugs. Don't let short-term economics get in the way of allowing use of this low cost, cost-effective technology.

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I have found ICG extremely helpful in treating drug resistant HTN and newer onset HTN nonresponsive to lifesyle modification and initial drug therapy. I have overall seen faster results when ICG is used to determine the best medications to be used. As my local carrier no longer covers ICG, I have had to revert to guess work and my success in BP control has decreased. The prospectively designed randomized trials data support a policy that is national and enables treatment of pts uncontrolled after lifestyle modifications and initia drug therapy.

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I find the ICG technology absolutely necessary in treating patients with hypertension. I am able to effectively prescribe and titrate BP meds including, but not limited to vasodilators, ARBS, and diuretics. I have seen a major improvement in my patients as a result of this. This directly correlates with the results of the CONTROL and Mayo clinic studies which determined that ICG is effective and essential in treating HTN as compared to satandard care. I encourage CMS to refer to the published data which support national coverage of ICG for hypertenive patients uncontrolled on 2 and 3 medications.

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We find merit in the request to cover thoracic electrical bioimpedance (TEB) hemodynamic monitoring for the management of hypertension that is treated with one or more drugs and to provide this coverage uniformly nationwide. Upon careful review of the patient populations of the submitted and/or referenced clinical studies (PREDICT and CONTROL) in support of the request to CMS, we find that the patients meet the ACC/AHA definitional criteria for hypertension monitoring and management. These criteria are not based upon a single risk factor, they do not anticipate that blood pressure monitoring is the sole means to diagnose and control therapy, and they do not recommend caution when it comes to preventing heart failure (HF). Based on our review, we strongly urge CMS to support the targeted use of TEB in the management of essential or secondary hypertensive patients who minimally meet the definitional criteria for “At Risk” as outlined in the 2005 ACC/AHA Practice Guidelines for the Diagnosis and Management of Heart Failure.

Patients in HF Stages A and B may have refractory or resistant hypertension. Patients who proceed to Heart Failure (Stages C and D) typically require a three-drug regimen that includes a diuretic to control their hypertension; therefore, their hemodynamic condition unquestionably merits TEB monitoring. In Stage A HF, the opportunity exists to resolve and/or mitigate risk factors underlying these patients’ disease processes. The medical achievement of normalized systolic and diastolic blood pressure and maintenance of adequate vascular volume and pressure — while not interfering with mentation, ambulation or urination — is not a trivial hemodynamic goal for patients within Stage A and B, particularly as they age and if they progress from A to B. However, it is within the “At Risk” stages where cost and health outcomes are more amenable to control. It is therefore inadvisable to limit the use of TEB to management of resistant hypertension since this is a condition of patients who have likely already progressed from the “At Risk” stages into the more precarious and costly phase of HF.

One could argue that the use of conventional vital signs offers sufficient insight into delineating the circulatory pathophysiology. If this were true, then we would have made statistically significant progress in controlling annual Medicare expenditures on office visits, hospital-days and drugs. The fact is that it is often impossible to determine a patient’s true clinical state from an analysis of blood pressure, respiratory rate, oxygen saturation and heart rate when considered alone or in combination. These simple parameters are readily available in most clinical settings and the information provided is valuable, but their diagnostic power is limited when it comes to defining the dynamic state of the heart failure patient or in implementing end-goal directed therapy for the Stage B or C HF patient who has several co-morbidities. Additionally, the real-world management of the majority of these patients becomes a subjective trial-and-error approach. There is a heavy reliance on self-reporting of symptoms. In the dramatically increasing elderly population that comprises the “At Risk” and Heart Failure populations, this management methodology is clearly not going to improve the existing morbidity, mortality or economic realities.

We believe that TEB is necessary to assess and verify the hemodynamic baseline of all “At Risk” patients whether their hypertension is controlled or uncontrolled. Cardiac output (CO) is the single-most important driving force in the circulation, and hypertension is the single-most important risk factor in circulatory disease. The availability of a complete hemodynamic panel that includes heart rate, CO, stroke volume (SV), systemic vascular resistance (SVR) and thoracic fluid content (TFC) on a continuous beat-to-beat basis, in both passive and graded-stress situations, is essential to total hemodynamic understanding. This puts hypertension into the broader contextual understanding described eloquently in the teachings of Dr. Arthur Guyton wherein one considers MAP alongside vascular and pulmonary resistance (Circulatory Physiology: Arterial Pressure and Hypertension. WB Saunders Co. 1980). The use of TEB to provide this elucidation puts it alongside simple vital sign assessment and allows the healthcare provider to manage hypertension within the context of all factors affecting a patient’s hemodynamic state and therefore make informed treatment decisions. Trending hemodynamic data for Stage A and B patients is invaluable to the ACC/AHA stated primary goal of “reducing blood pressure through the informed selection of drugs that are determined by concomitant medical problems”. This means titrating and tailoring therapy in order to preserve quality of life for as long as possible as the patient ages and as his/her underlying disease progresses.

Various hemodynamic data are used to support definitions of patients at-risk of HF, to discriminate between stages of HF, to manage metabolic syndrome and to monitor the efficacy of recommended cardiovascular therapy. The use of hemodynamic data is mandated by the fact that the HF patient population is elderly and characterized by two significant co-morbidities: diabetes mellitus (DM) and peripheral arterial disease (PAD). DM and PAD can co-exist and may be further exacerbated by refractory or resistant hypertension. These patients are hemodynamic complexities and their management requires the benefit of all components comprising a hemodynamic panel i.e. CO, SV, and SVR as well as thoracic fluid content (TFC) and contractility data. The full hemodynamic panel as provided noninvasively by TEB allows the physician to evaluate total hypertension (pressure and resistance). Graded-stress testing can result in the re-evaluation of hypertension control once it is used to assess cardiac functional capabilities. Importantly, signal-averaged TEB is well-suited for the dynamics of exercise testing.

Finally, consider the definition of drug-resistant hypertension. It offers all the insight we need to understand why hypertension and heart failure are top consumers of health care expenditures in the United States. Drug resistant hypertension is “the failure to achieve goal blood pressure when the patient is adhering to full doses of an appropriate 3-drug regimen that includes a diuretic”. The key words are “adhering”, “appropriate”, and “full doses”. The “At Risk” HF patient population is comprised of patients who are characterized by non-compliance and high risk behaviors. The nature of these patients, their stage of disease and the lack of true hemodynamic monitoring in an office setting requires that trial and error are used to accurately and “economically” verify the right drug cocktail, the patient’s compliance and true day-to-day clinical control. This is challenging in the best of circumstances but becomes exceedingly complex when confounded with patients dealing with multiple risk factors, populations that are guaranteed to dramatically increase secondary to aging baby-boomers and the continued use of only the most basic of diagnostic building blocks (BP, HR, patient history) in the office setting.

We represent that access to a noninvasive technology that reliably provides the definitional components of hypertension – mean arterial pressure (MAP), cardiac output (CO) and systemic vascular resistance (SVR) – during rest and exercise, should be available as a nationally reimbursed diagnostic test for all refractory and resistant hypertensive patients who are defined by HF Stages A-D. This definition provides the control and framework that we believe CMS seeks and is supported by the data that were submitted (PREDICT and CONTROL). TEB provides simple access to hemodynamic data that, when viewed alongside traditional vital signs, takes the guesswork out of diagnosing, monitoring and treating the full spectrum of HF patients as defined by ACC/AHA guidelines.

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The availability of ICG in my clinical assessment of HTN has demonstrated to me and my patients that I can get lower BP values since incorporating ICG into my care about 7 years ago. I have practiced cardiology for 25 years and know the value that ICG has contributed to my clinical care. This, in conjunction with 2 peer-reviewed RCTs published in HYPERTENSION, should be sufficent evidence for CMS to expand their HTN coverage to pts not responding to 2 or more drugs. Carrier discretion is a poor means of administering a policy and in Texas we have been disadvantaged, as well sas our Medicare patients, as we have not be able to use ICG for hypertension due to our carriers discretion NOT to cover. Please provide a national policy which the clinical data justifies.

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Impedance cardiography helps determine SVR (Systemic vascular resistance) in patients with essential hypertension. This information is critical in the proper selection of anti-hypertensive medication. Whether the SVR is high, normal or low has a direct impact on the medication selection for treatment. I also use the fluid and cardiac index parameters in my selection of medication. I support an expanded CMS policy to allow imedance cardiograpy use on essential hypertenive patients on less than 3 drugs. Thank you for allowing the opportunity to provide a public comment on my experience.

Robert R. Coll, MD
Buckeye Medical, Inc

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I do not agree with CMS draft decision for ICG hypertension coverage. First of all, I practice in NY and we have long not had CMS coverage of hypertension because of the carrier discretion stipulation. That stipulation is CMS way of ensuring most carriers will not cover. Strong medical data exists from 2 RCTs for use of ICG in hypertensive patients and ICG deserves a national policy for patients uncontrolled on 2 or more antihypertensives. CMS also has plenty of positive clinical experiences from its providers.

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In my 20 years of treating hypertension, I have strived to beat the national control rates for hypertension as I have long felt that if I could control this disease I could save my patients from considerable morbidity and mortality as well as save our nation considerable expense. ICG has provided data, that along with my clinical assessment and judgment, has resulted in faster and improved control rates. Your analysis questions the mechanisms, but regardless of how ICG data affects physicians, the results on improved BP are indisputable. Unfortunately I reside in NY and Empire (CMS contracted carrier) does not allow ICG use for high BP. Medicare patients do not receive the same quality care as my private patients which is not right. I urge you to create a national policy for use of ICG in patients not at goal BP and on 2+ medications. Thank you,

Peter Longo, MD, FACC

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The use of ICG data has given me the ability to direct therapy at the specific cause of a particular patient's hypertension. It has shortened the time it takes for me to successfully bring the pt. to their blood pressure goal. The Pennsylvania contracted CMS carrier has changes its policy for hypertension several times, including different ICG-9 codes. I request that you standard the policy to have national coverage, standard codes and allow use of ICG on patients not a their blood pressure goal and on 2 or more medications.
Elliot Gerber, M.D., F.A.C.C.
Mainline Cardiology Assoc, PC

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I respect the CMS concerns voiced in the draft decision memo about whether the evidence that was submitted supports the requested broad coverage (1 or more meds with no restriction). However, the evidence clearly does support lifting the current carrier discretion status for ICG and providing national coverage in uncontrolled BP in a more narrowly defined population, perhaps with some limitations before and after testing.

Hypertension, like other conditions such as heart failure and sepsis, does not respond well to a “one size fits all” approach to treatment which some interpret evidence-based medicine to advocate. In contrast, goal-directed hypertensive therapy with ICG causes physicians to focus on more than just BP and to understand the underlying physiology, which in many cases is high systemic vascular resistance. Goal-directed treatment targeted at systemic vascular resistance results in more effective treatment of BP for the individual patient, as demonstrated by two randomized trials. We can all agree that better BP control is better for Medicare beneficiaries, so why won’t CMS allow better BP control to be accomplished with a few inexpensive ICG tests?

If CMS does not provide national coverage of ICG for a more restricted indication, independent observers may see this decision as inconsistent with previous coverage decisions on diagnostic tests. In addition, I believe that it would set an unachievable standard for future scientific advancements in diagnostic tests that can be used for goal-directed therapy. An unachievable standard of evidence will hurt the commercial pursuit of such technologies that would improve the quality and length of life for Medicare beneficiaries.

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In my Internal Medicine practice, uncontrolled hypertension is a common finding. I added the ICG to my practice for two reasons: 1) to document a need for and a response to change in antihypertensive therapy, and 2) to teach patients the importance of compliance to an anti-hypertensive regimen. The first time I saw the results verified by a drop in SVR for a particular patient, I was amazed. There was solid proof that the intended course of treatment was correct and not just supposed.I feel this tool helps me as a practitioner to make better informed decisions based on accurate and verifiable information. Once the patient sees the graph, they understand what it is we are achieving with therapy and they realize the importance of taking their medicines. Clearly, the ICG affects how I as a practitioner choose a medication class and I feel the results are parralleling those of the CONTROL trial in improving BP control in my patients whether they are on one or several anti-hypertensives. I would ask you to consider whether or not an investment in this technology today would improve short-term compliance and prevent long-term sequalae by meeting JNC guidelines. I believe the answer is yes and would ask you to allow national coverage for hypertension patients who are uncontrolled on one or more drugs. Thank You.

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I would like to comment my support towards CMS broadening the hypertension coverage for ICG. Our patients need us to utilize better methods to improve their BP control and minimize the number of drugs it takes to control them. We know this will lead to less side effects and toxicities. ICG has proven in prospective RCTs to help us achieve superior BP control and I know through my practice that I have been able to get patients with lower BPs, feeling better and on less drugs. We will never realize the full benefits of ICG if you do not broaden CMS coverage for ICG for hypertensive patients. Please lower the threshold to two drugs and make sure all Medicare carriers cover ICG for hypertensive care.

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I am a Diplomate of American Board of Internal Medicine and have treated hypertension for 22 years. In the time since I have added ICG data to my clinical assessment, I have been able to better assess and more accurately select antihypertensive medications as determined through improved blood pressure lowering. CMS should consider the practical experience of its providers in addition to the peer-reviewed randomized controlled trials and create a coverage policy reflective of the data which supports coverage on less than three antihypetensive medications.

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As a F.A.C.C., I have treated hypertensive patients for 20+ years. We have been searching for years for a better means of controlling hypertension and instead of improving control rates, the uncontrolled rates have been increasing. We are losing the war and our patients are suffering. I am mystified why CMS would not more fully embrace an inexpensive technology, such as ICG, to help in our quest to better control hypertension. The availability of ICG data to physicians has demonstrated to produce better BP control both in published evidence as in everyday clinical care. Pure and simple, we get better BP control when we have access to ICG data. Do the right thing and allow all Medicare providers to treat Medicare beneficiaries who are not controlled on 2 or more antihypertensive drugs.

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CMSI am a family practitioner, in practice for thirty seven years and have used the Bio-Z for the last three years. It is very useful to me in a variety of disease states including hypertension. By using the Bio-Z, especially getting the parameters of cardiac output, peripheral resistance and thoracic fluid content, I can streamline my treatment so patients do not have to be on three or more drugs.

This can save the patient and Medicare money and help eliminate problems of too many drugs and potential for adverse drug interactions. I believe that use of the Bio-Z in managing Hypertension is very cost effective, has proven to provide better blood pressure reductions in published studies and should be covered for 2 or more drugs.

Thank you for your consideration in this matter.

Sincerely, Duncan G. Bowell, M.D.

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Treatment options for improving hypertension control have in large part failed. ICG provides data for consideration as physicians consider treatment options and has improved our ability to control hypertension pressures. Tailoring therapy vs. standard approaches for all makes sense. It has proven in 2 randomized trials that the data helps achieve better blood pressure control for patients on 1,2,3 or more meds. CMS policy needs to allow use on at least patients on 2-3 drugs and still in need of BP control.

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I am a nephrologist and hypertension specialist who has treated hypertension for 14 years. I have found the ICG BioZ data very helpful in my assessment and in modifying the treatment of uncontrolled, labile HTN. I believe their is sufficient evidence to support ICG coverage for hypertensive patients uncontrolled on 2 or more drug, especially patients with comorbidites, including chronic kidney disease. I practice in NJ whereby we have a contractor who does not allow coverage and I request that carrier discretion be removed and make it a national coverage policy to allow fair access for all patients and medicare contracted physcians.

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This is a public comment regarding CMS draft policy for ICG HTN coverage. I disagree with CMS opinion that there is insufficient evidence for expansion of HTN coverage. The Control study achieved the primary study endpoint: greater reduction in systolic & diastolic blood pressure in the ICG vs. standard care group.The ICG group exceeded the standard care group by 35% for < 140/90mm Hg.

The results in reductions of 8/7mm Hg in the CONTROL study has significant outcomes in terms of CV morbidity and mortality. The control trial expands the clinical evidence of the Mayo Clinic study and provides rationale for expanded HTN policy. I have treated HTn for 25 years and know that ICG can make a big difference in control rates.CMS needs to balance their need for controlling costs with benefits of beneficial technologies. I have used this important ICG data in my care and can attest to its value in clinical practice and contribution to improved blood pressure control. The two RCTs results justify deleting Medicare contractor discretion language and providing a national coverage policy for uncontrolled hypertensive patients on less than three drugs.

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ICG is a very important test to treat hypertension in patients on 2 or more drugs. It has been critical in helping me to identify the correct choice of drug and effectively lowering many patients blood pressure values. CMS proposed policy does not reflect the results of the two RCTs and does not support evidenced-based medicine principles. I recommend a policy reflective of the trial results that support a policy for hypertensive patients not controlled on 2-3 drugs.

Sunil Menon, MD
Diplomate of the American Board of Internal
Medicine
Assistant Clinical Professor of Medicine
Yale University School of Medicine

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In my 26 years of clinical experience treating hypertension and 3 years of using ICG in my hypertensive care, I find that ICG testing gives clinical information to better help direct my selection of appropriate pharmacologic therapy in treating HTN. ICG provides data to help me in monitoring clinical response to antihypertensive therapy and obtaining a differential diagnosis in patients with dyspnea. CMS draft decision does not support the evidence submitted nor the clinical experience of providers. I recommend a national coverage policy that allows utilization on patients unresponsive to 2 to 3 antihypertensive meds.

Robert Cameron, M.D., F.A.C.C.

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This is a follow up comment based on the recent draft proposal issued by CMS regarding coverage of thoracic electrical bioimpedance (TEB) for patients with hypertension.

The proposed coverage decision is no change from the existing coverage determination. It allows each individual carrier to decide whether or not they will cover for drug-resistant hypertension. In Texas, that is the equivalent of noncoverage. Our CMS-contracted carrier (Trailblazer) does not recognize any role for TEB in any patient for control of hypertension. This is clearly inconsistent with the available literature, including the two randomized controlled trials (the Mayo Clinic study and the newly published CONTROL trial) that demonstrate a clinically significant benefit with TEB-guided therapy. When adequate clinical evidence exists, CMS should make a determination that applies to all carriers and all states. I emphatically object to carrier discretion in this case and in future cases, if only because it results in a greater number of less qualified groups (i.e., the carriers) making more arbitrary coverage determinations. Inconsistency is a symptom of poor quality, and inconsistent coverage of TEB among the various Medicare carriers results in suboptimal quality of care.

I can understand that in this era of tremendous concerns about the costs of healthcare, CMS is reluctant to expand coverage for any procedure. However, TEB is not an expensive procedure. And, our poor control of hypertension as a nation represents a huge opportunity to provide better care and improve the health of our population.

In short, it is reasonable that CMS require that all carriers cover for hypertensive patients under some conditions. If there is concern about too liberal a coverage expansion, then I support something less expansive, such as national coverage for patients who are not controlled on two or more medications. Thank you very much for your consideration.

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CMS, Your proposed decision memo for electrical bioimpedance for hypertension coverage is inconsistent with the results from two RCTs, the CONTROL (Smith et al) and Mayo Clinic (Taler, et al) trials that showed improved blood pressure control in the ICG arms as compared to our standard methods of treating hypertension. The CONTROL data supports expansion of the existing coverage and carrier discretion is not justified. These 2 RCTs provide sufficient clinical evidence and accordingly, CMS should implement a coverage policy that binds all contracted carriers and allows for coverage of hypertensive patients who are uncontrolled on less than 3 drugs.

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CMS,
I am writing in disagreement with your draft decision not to enhance ICG hypertension coverage and am hopeful that you will reconsider the available published RCTs clinical evidence as well as consider my "real world" internal medicine clinical experience as well as that of many of my colleagues.

As evidenced from the overwhelming number of positive comments in the first comment period and now again in the second period, there is tremendous physician support due to the immense benefit practitioners receive from having ICG data in the care of hypertensive patients. The support is certainly not due to the low reimbursement we receive for performing this test but emanates from the encouraging hypertension control rates when using ICG. Our support is in addition to the strong evidence from two RCTs. Please take into account our experiences as well as the RCT results and create a coverage decision that will benefit Medicare beneficiaries. They are being cheated out of availability to sound medicine because of your current policy. I support coverage for patients uncontrolled on multiple antihypertensive medications and request that you eliminate the carrier discretion portion. I practice in Texas and our local contractor has never covered for hypertension. Our Medicare patients have suffered due to this clause. Again, I greatly appreciate your willingness to hear our experiences.

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I treat numerous hypertensive patients and because of CMS existing and proposed continuation of restrictive coverage for ICG for hypertensive patients, I am unfortunately providing inferior care to my Medicare patients because of coverage restrictions. ICG is an inexpensive, low risk, high benefit, intelligent means of augmenting our hypertensive patient care. It is surprising that CMS would be so hesitant to improve coverage for a procedure that nicely fits with our need to improve hypertension control and need for cost-effective medicine. ICG also has high quality clinical evidence in the form of randomized, prospective controlled trials published in the foremost hypertension journals. Your policy is not logical. I submit for you to craft a national policy supporting the published evidence and provide for coverage for patients on 2 or more drugs and still not at goal blood pressure. Thank you,

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ICG has been very effective in monitoring HTN, adjusting medications and achieving BP control. I also attribute ICG to a decrease in hospital events. I do not agree with a carrier discretion clause in the policy as our Medicare patients are deprived access to ICG because our Trailblazer carrier does not allow ICG monitoring for HTN. Based on the clinical trials and my clinical experience, I recommend a policy ensuing coverage by all local carriers for HTN in pts not controlled on < 3 drugs.

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CMS,I am writing to voice my concern with CMS proposed decision memo regarding hypertension coverage for ICG. In the two RCTs (Mayo and CONTROL) as the results are reported, there is little question as to whether the provision of ICG leads to better BP control. CMS poses many questions related to the mechanisms for improved BP control. Regardless of whether it was through better drug selection, availability of additional data or because the ICG report reminded physicians to more aggressively address clinical inertia and treat BP, availability of ICG data was the only different variable and the ICG arm had superior BP control.

Based on evidence-based principles and the results of the two RCTs, CMS currently proposed coverage is not consistent with evidence-based medicine. The evidence from the RCTs support a national coverage policy for ICG for hypertensive patients not at goal blood pressure on multiple drugs. I suggest you consider the different risk groups and stratify coverage for two groups of patients. It is reasonable to consider a two drug policy for higher risk patients and a three drug policy for lower risk patients. I have utilized this stratified approach for two drugs in my practice (for non Medicare, high risk) and it has been effective. Carrier discretion is an impediment to consistent policies and practices and is not reasonable given the level of evidence for ICG in the treatment of hypertensive patients. I appreciate your request for comments and hope you will consider the suggestions of experienced clinical users.

Paul Grodan, M.D., F.A.C.C.

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CMS recently-proposed ICG policy for hypertension is not supported by the results of the two randomized controlled trials the Control and Mayo Clinic RCTs. In the CMS analysis, it is acknowledged that use of randomization, contemporaneous control groups, and prospective studies ensure more thorough and systematical assessment of factors related to outcomes yet you are disregarding results of two RCTs that employ these evidence-based principles. The results of these two RCTs clearly show improved outcomes through lower blood pressure. The blood pressure lowering results are indisputable and should not be minimized or invalidated due to potential questions about mechanisms of blood pressure lowering. Lowering blood pressure is validated to improve outcomes and leads to reduced incidence of ischemic myocardial infarctions, strokes and heart failure. I encourage you to accept the results of the RCTs and model a coverage policy after the results.

I understand the economic implications of treating every hypertensive patient but certainly this concern should not cause CMS to invalidate the results of evidence-based medicine. Perhaps an acceptable policy would be for utilization on patients uncontrolled on three drugs if there are not co-morbidities and/or cardiovascular risk and utilization on patients uncontrolled on two drugs if there are co-morbidities such as diabetes, kidney disease and/or cardiovascular risk. I practice in New Jersey and our Medicare contractor has not covered ICG for hypertension alone for many years. I am adamantly opposed to carrier discretion as it causes inexperienced medical directors to make ill-formed decisions that has resulted in unfair access for Medicare patients and physician providers. Thank you again for modeling a policy based on the RCT results.

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Use of ICG optimizes medications in the treatment of hypertension and reduces/controls end organ damage. Use of ICG also reduces hospitalizations and saves money. CMS draft policy does not reflect the RCT evidence supporting that ICG achieves better blood pressure control. Also leaving coverage to carrier discretion is a joke and a means for non coverage. I strongly oppose this type of policy and feel CMS should write a policy reflective of the data and allow national coverage for hypertensive patients remaining uncontrolled on 2+ meds.

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I have treated hypertension >15 years and am a M.D. and Ph.D. I was shocked to read your analysis and summary that the data presented in the CONTROL study are insufficient to establish the clinical benefit of HD monitoring with TEB as a means of achieving better blood pressure control and that you do not have adequate evidence to determine the reported difference is in fact due to actual physician use of the results of TEB monitoring. Regardless of whether the physicians used the TEB data, the availability TEB data was the only difference between the arms and the results demonstrated that the TEB arm achieved better blood pressure control. You are applying extremely unrealistic standards to this technology. Two RCTs are more than sufficient evidence and more than you have had in many of your positive coverage decisions. It is obvious that you are not being objective in your evaluation. In addition to the two RCTs, there are plenty of clinical testimonials from user physicians that also verify the clinical usefulness of ICG. I, for one, have seen considerable changes in my treatment and ability to control patients on two or more drugs since I started using ICG. Regardless of any questions one can create, the bottom line is the availability of ICG results in improved blood pressure control. CMS needs to get this coverage right for the sake of patients and providers. A moderate coverage policy would allow national coverage for patients not at goal BP on 2-3 drugs.

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In my practice, the Bio-Z machine has been extremely helpful in the diagnosis and treatment of hypertension. I don't agree with your proposed policy and support an expanded coverage policy that allows me to use the Bio-Z on hypertensive Medicare patients that are uncontrolled on multiple medications. I live in Texas where our local carrier, Trailblazers, does not allow coverage due to CMS policy of carrier discretion. Please remove that discretion and provide uniform access to Bio-Z ICG.

Philip T. LaBarbera, M.D.

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CMS, As a M.D., Ph.D, having treated hypertension for 21 years, I am commenting on your proposed policy for hypertension coverage for ICG. I am very concerned with your conclusion that there is insufficient evidence for expansion of coverage. The CONTROL trial definitively reached the primary study endpoint of reductions in systolic and diastolic BP, which exceeded the standard care arm by 35% for a target of BP of < 140/90. The reductions of 8mm Hg systolic and 7mm Hg diastolic in the CONTROL trial has significant implications given the Lewington meta-analysis of over one million patients demonstrating that as low as a 2mm Hg lowering of SBP had a 10% lower stroke mortality and 7% lower mortality from ischemic heart disease or other vascular causes. These outcomes are significant. Given the CMS coverage policy based on the Mayo Clinic trial results, there is justification for expansion of policy with the new CONTROL results.

It can be assumed that CMS is concerned with the economic implications of covering hypertension at large. Given that reasonable concern, I was surprised to read your statement that CMS does not consider costs in NCDs. I have implemented this low cost, highly valuable data into my clinical practice and can verify to its value in clinical practice and leading to improved blood pressure control. Given the results of two randomized controlled trials that were prospectively designed, I would recommend deleting carrier discretion and allowing national coverage for uncontrolled hypertensive patients on less than 3 drugs. Thank you for your consideration.

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H. Joseph Blair, MD FACC

This is a public comment for CMS draft decision on ICG hypertension coverage. I am dismayed that you are discrediting two prospective, randomized controlled trials demonstrating superior blood pressure control and reduction as compared to standard care. Your analysis references in Appendix A that in the hierarchy of evidence that randomized controlled trials are the most superior and you do not even list review articles, yet you state in your Internal Technology Assessment that "CMS performed extensive literature search...for new randomized controlled trials (RCTs) and systematic reviews...". Why would you search the two extremes of the spectrum, from the most superior (RCT) to the most inferior, a systematic review, that is not even listed for consideration in terms of ranking research design. It is incredulous that CMS would discount the results of two randomized controlled blood pressure trials as insufficient evidence and suggest they are not generalizable to the Medicare population. We frequently apply data from < 65 yo to the Medicare population. The FDA does so routinely and the incidence of hypertension only rises with age. It is well accepted that over 60% of elderly hypertensive patients who are under treatment have not achieve systolic blood pressure control. I would hope CMS would take advantage of a technology such as ICG that has proven to improve BP control better than our current methods while utilizing evidence based principles. Certainly a national coverage policy for ICG on hypertensive patients uncontrolled on 2+ drugs would be reasonable and significantly assist in the control of hypertensive Medicare patients.

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I am commenting on Medicare's draft decision on hypertension coverage for Bioz ICG. In my practice, ICG provides more efficient control of BP in difficult to control patients on two or more drugs. Better medication choices directed by ICG data showed in randomized controlled studies to yield quicker BP control. The CONTROL study primary endpoint of the ICG group achieving BP the standard care group achieving 57% control was reached in a statistically significant manner. Based on evidence based medicine, this is all that should be needed to provide expanded national coverage for ICG to hypertensive patients uncontrolled on two medications.

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In my opinion it is necessary to revise the indication for drug resistant hypertension for 93701 ICG cardiac monitoring and therefore I do not agree with CMS initial decision not to revise/expand the coverage. There are three major reasons for my opinion: our practice clinical experience, clinical evidence and non uniform access due to carrier discretion. In our practice, we feel that evaluation of patients on multiple antihypertensive drugs with ICG (BioZ) has been a very significant advance in the treatment of my patients allowing me to titrate medications and see the results in a much faster (and safer) pace than traditional “wait and see” method of medication change. It is an essential tool in the proper treatment of not only resistant hypertension but also on patients who are less resistant and on two or more medications. The clinical evidence is of a randomized, contemporaneous controlled arms, prospective basis that has demonstrated to have statistically and clinically significant outcomes the can be extrapolated to the Medicare population. The blood pressure reductions in the Mayo Clinic were 4/3 mm Hg greater for resistant hypertensive patients as compared to the standard care. The Control trial were 8/7 mm Hg greater reductions for uncontrolled patients on 1,2 or 3 drugs as compared to the standard care arm. These translate into significant long term reduction in MI, strokes and heart failure. It is ridiculous for CMS to state that there is insufficient evidence for expansion of coverage to less than three drugs and to leave it at carrier discretion. The current NCD allows each carrier medical director to make an individual coverage determination for this service, even if they have limited or no experience with using non-invasive hemodynamic information. This is not a fair method of coverage and has resulted in inconsistent coverage and access across the country. I ask that Medicare make it a mandatory indication for all CMS carriers to cover hypertensive patients uncontrolled on two or more medications.

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As a contracted provider of Medicare and a user of ICG technology, I fully support the expanded coverage of ICG for hypertension to include patients with hypertension who are on multiple medications and am disappointed your initial proposed policy. There are two randomized clinical studies to substantiate ICG use in patients with uncontrolled hypertension, certainly on multiple medications. The most recent study, the Control trial, demonstrated improvement in blood pressure control with ICG-guided therapy in patients on one to three drugs. The Mayo Clinic study by Dr. Sandra Taler showed a 70% improvement in BP control using ICG on patients on multiple medications. As a nephrologist, I treat many patients with serious kidney disease as a result of years of uncontrolled hypertension. We must do something different to help stem the rising tide of uncontrolled hypertensive patients. ICG has statistically proven to be more effective in lowering BP than our standard methods including JNC guidelines. I strongly encourage you to more fully consider the clinical evidence and expand this indication to patients with hypertension that are uncontrolled on multiple medications.

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I treat a variety of cardiovascular disease states including many hypertensive patients. I have found the ICG to be highly effective in directing my pharmacologic intervention for these patients. In hypertension, ICG provides an objective assessment and assists in my objective selection of antihypertensive medications. I noted in your analysis that you questioned how ICG caused a difference in medication class and dose selection. I thought this was definitely stated in the Control manuscript (Hypertension, April 2006). For example, it stated that greater use of vasodilators when SVRI was high; less use of beta blockers when CI was normal or low; fewer does increases and decreases. These reporting are similar to my practice. The Control and Mayo trials are definitely applicable to the Medicare population and it appears that CMS is looking for reasons not to expand coverage vs. look objectively and fairly at this evidence. Please be objective and provide expanded coverage reflective of the evidence which shows justifiable coverage for unresponsive HTN patients on 1,2,or 3 medications. If you want to limit use, then have a coverage policy that has all carriers covering for MCS patients not controlled on >2 drugs.

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Thank you for the opportunity to comment on the national hypertension policy for TEB. I have utilized TEB in my office for the last few years. It has changed the way I manage my patients with various cardiovascular diseases, including patients with resistant and nonresistant hypertension. The methods of prescribing and results I have seen in my practice correlate with the published clinical literature. Your analysis questions whether TEB caused a difference in medication class and doses in the Control trial, and I felt that this was reported in the manuscript to show that TEB had clear difference in drug selection according to abnormal hemodynamic data. For example, greater use of vasodilators when SVRI was high and less use of beta blockers when CI was normal or low. The patient populations in both the Control and Mayo studies were reflective of the Medicare populations and a three month trial is similar to gains in large pharmaceutical trials.

I support the expanded coverage to include patients with uncontrolled hypertension, on two or more drugs and request that the individual carriers do not have the discretion to decide coverage. All patients and providers in all states should have access to this important clinical tool. Because our local carrier is Trailblazers Healthcare Enterprise, my Medicare patients with resistant hypertension have not had access to this valuable test. It is unfortunate that patients who have a commercial carrier are the only ones benefiting in my state from this valuable technology.

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Our group practice employs electrical bioimpedance to measure non-invasive cardiac output, systemic resistance and thoracic fluid volumes in our patients. Electrical bioimpedance has provided significant benefit in defining the hemodynamic mechanisms underlying arterial hypertension. It has been of considerable value in identifying the most appropriate additional steps in antihypertensive therapy, especially for those patients on two or more medications. Electrical bioimpedance guides our therapy and allows us to monitor patient progress in difficult patient management situations. Very similar to the randomized Control and Mayo clinic trials electrical bioimpedance changes how we select and dose medications targeted at underlying hemodynamic mechanisms, which is clearly a better, more objective approach than the trial-and-error standard method. We do not support CMS criticisms of the clinical evidence submitted and believe that CMS should work with the principle investigators and reviewers of the journal to better understand any questions they may have. These studies would not have passed peer-review without credible methodological study design and results.

We support and recommend this service should be available to hypertensive patients not at goal BP and on two or more antihypertensive medications. Discretion on whether to cover it should not be left to the carriers. This has results in changing policy without additional evidence and inconsistent coverage for patients and providers as has happened in the New York and New Jersey areas.

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I have treated hypertension for 25 years and used ICG in my hypertensive treatment for the last three years. In my experience and the experience of my colleagues, ICG hemodynamic information is instrumental in getting a patient to goal blood pressure. I cannot understand the logic behind allowing coverage for only patients on a 3-drug regimen. The physician goal is to get their patients to BP goal on the minimum number of medications and the more medications a patient is on, the greater the likelihood of drug interactions and intolerance, especially in the elderly. The ICG hemodynamic data provides necessary information when other standard assessment methods, like JNC VII are unsuccessful, regardless of the number of medications. This methodology has been proven superior to standard clinical care in two randomized controlled trials. CMS raises many questions but the hypotheses of the trials were only to lower blood pressure in the ICG arms and that was conclusively achieved. I have so much trouble with reimbursement and it is because of the current policy. I do not support CMS decision to leave the policy unchanged and recommend CMS provide coverage by all CMS carriers for the indication of hypertensive patients uncontrolled on two or more antihypertensive drugs.

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I do not agree with CMS draft decision to leave carrier discretion and the 3 drug criteria for ICG hypertension coverage. There is a major issue in the current policy that has many physician colleagues in the NY/Empire-contracted area extremely frustrated. Physicians believe in ICG and know the value of having access to accurate, safe and low-cost noninvasive hemodynamic data. We urge you to allow us to use this tool in patients with hypertension, as its benefits over empiric therapy have been shown in the multi-center generalist CONTROL trial as well as the Mayo clinic study a few years back. These study designs are credible and represent the highest level of design and have statistical significant bp reductions. Although the CONTROL data shows value in hypertensive patients on one or more drugs, a reasonable national policy would eliminate contractor discretion and cover for unresponsive patients on two or more drugs.

Hemanth Badhey, M.D., F.A.C.C.

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CMS I have reviewed your proposed policy and evaluation of ICG for hypertension coverage and was dismayed with your conclusion of insufficient evidence, given two randomized controlled trials that incorporate methodological attributes associated with stronger evidence.

For assessing studies CMS cites that methodologists have developed criteria to determine weaknesses and strengths of clinical research. You also state that methodological attributes associated with stronger evidence include:

1. Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.
2. Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.
3. Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.
4. Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population.
5. Masking (blinding) to ensure patients and investigators do not know to which group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor.

CONTROL and Mayo trials encompassed ALL the above attributes with the exception of blinding/masking which is impossible in the CONTROL and Mayo trials because the treating physicians needed to use the icg data (intervention) in deciding patient treatment.

CMS further states that "rankings of research design have been based on the ability of each study design category to minimize...biases. A randomized controlled trial minimizes systematic bias (in theory)...by selecting a sample of participants from a particular population and allocating them randomly to the intervention and control groups. Thus, in general, randomized controlled studies have been typically assigned the greatest strength." Since RCT are assigned the greatest strength, your issues with the MAYO and CONTROL trials are confounding and CMS'proposed study is inferior if one considers the methodological attributes described.

Your evaluation states "when making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary and that the intervention will improve health outcomes for patients." Both ICG RCT reduced blood pressure in a statistically significant manner and reduced blood pressure has certainly been demonstrated to improve health outcomes for patients through reduction of morbidity and mortality associated with cardiovascular disease.

I, too, will attest to the clinical value of ICG in the care of my hypertensive patients. ICG has significantly improved my selection of drugs and control rates. I urge you not to dismiss the quality data and results from these important trials and to broaden HTN coverage for uncontrolled patients on multiple antihypertensive medications. Also I urge you to remove carrier discretion clause as it has resulted in unfair and inconsistent access for doctors and patients alike.

Steven Y. Engrassia, M.D., F.A.C.C.

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This comment is being registered as disagreement with the CMS proposed coverage and is in support for enhanced hypertension coverage for ICG to include patients with uncontrolled hypertension on two or more medications, although there is evidence for coverage on less than two medications. I also strongly urge you to eliminate the ambiguity of contractor discretion and provide national guidelines mandating coverage. The published trials are evidence based and there should be ample clinical evidence for this recommendation if CMS were to apply the same standards they have for previously covered technologies. I certainly have seen my patients benefit from my access and use of ICG in guiding treatment decisions.

Thank you for giving consideration to this comment,

Anthony Adeosun, M.D., F.A.A.F.P.

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I am writing to express concern with your proposed policy for ICG in hypertension. We utilize the BioZ monitor in our group practice and want you to know that ICG provides valuable and accurate information that is used to determine the best method of treatment for our hypertensive patients. Having cardiac output, fluid levels and vascular resistance provides physicians missing data required to accurately assess and treat our hypertensive patients. We encourage you to reevaluated and obtain clarification of your questions on the high quality CONTROL and Mayo clinic randomized trials. The bottom line is that these studies incorporate the highest criteria assigned to study design and demonstrate that blood pressures are statistically and significantly lower than standard car when using ICG to guide treatment. This translates to better patient outcomes. This should be enough evidence for a national policy, eliminating local carrier discretion, for hypertensive patients uncontrolled on 2 or more drugs. Please consider a more objective and fair policy such as this. Thank you,

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I regretfully read your proposed coverage decision for ICG in the care of hypertension. The BP reductions I have experienced since incorporating ICG into the care of my hypertensive patients has been similar to the published studies which have demonstrated in a randomized, controlled and prospective manner to statistically reduce blood pressure better than that of our standard methods. CMS has covered other technologies, including recent decisions in the last few years for t-wave alternans and ambulatory blood pressure monitoring, that do not have nearly the quality of evidence that ICG does in hypertension; therefore, it really does not make sense why CMS would hold ICG to a higher standard. In my practice, I utilize ICG to assist in the clinical assessment, pharmacologic selection and treatment of hypertensive patients. ICG provides cardiac output, vascular resistance, contractility indices, and fluid status, information that is simply not available in the outpatient arena. ICG significantly aids in the selection and dosing of diuretics, beta-blockers, vasodilating agents. Given the randomized, controlled and prospective published studies, excellent statistically significant accompanying results and the major healthcare problem of hypertension, I encourage CMS to modify its proposal to delete contractor discretions and include coverage fro uncontrolled patients on two or more medications. Thank you for your consideration,

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On behalf of our clinic, I am writing to express our support for coverage of impedance cardiography services in patients with uncontrolled hypertension on two or more medications, as well as removing the coverage discretion for contractors. We are disappointed in your evaluation and proposal and believe that if one objectively analyzes accepted study design methods and compares those to the submitted evidence of the CONTROL study, then one would agree that the coverage should be broadened beyond that given for the Mayo clinic trial which was carrier discretion for 3 or more drugs. The CONTROL trial is sufficient evidence for expanded coverage and CMS is being short-sighted by not embracing impedance cardiography which has, and can, continue to help in blood pressure management and control in a cost-effective manner if CMS would allow an expanded and reasonable policy.

To restate, we support coverage of impedance cardiography in patients with uncontrolled hypertension on two or more medications, as well as removing the discretion for contractors.

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Based on the clinical evidence submitted, personal clinical experience, as well as that of thousands of other physicians, I do not agree with your decision not to expand ICG coverage for hypertensive patients based on insufficient evidence. The Mayo and CONTROL trials are prospective, randomized controlled trials that statistically demonstrated improvements in blood pressure control superior to the results of standard care. Additionally, both have been published in the leading hypertension journal and, as part of that publication process, have been peer-reviewed by hypertension experts. CMS should trust the judgment of hypertension experts.

For the past four years, I have been utilizing a noninvasive ICG hemodynamic device, CardioDynamics' BioZ device, to measure cardiac parameters that are helpful in the outpatient setting. I have optimally adjusted medication regimens based upon noninvasive measurements of Fluid levels, Cardiac Index, Cardiac Contractility, and Systemic Vascular Resistance. These parameters objectively direct my prescription of beta blockers, calcium channel blockers, ACEIs, ARBs, and diuretics and have definitely improved the hypertension control rates of my patients.

I cannot emphasize enough the value of this diagnostic method to treat my patients with high blood pressure. I support expansion of this national coverage policy to include hypertensive patients on multiple antihypertensive medications. In addition, I believe CMS should remove carrier discretion for obvious reasons of uniform access and provision of this important technology.

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I am sorry to see your proposed decision for not expanding hypertension coverage for ICG. Given that you had carrier discretion on 3 drugs for Mayo clinic evidence, I am confounded why the Control study would not add to the evidence to provide sufficient evidence for an enhanced coverage for at least national coverage on 2 drugs. Evidence based medicine would support this enhanced coverage and evidenced based medicine has been the new mantra for CMS. From my knowledge and inquiry with respected study design colleagues, CMS study design suggestions for ICG are not as robust as the 2 RCT that have been published. I strongly request the CMS re-analyze the evidence before you and take into account the supporting user experience and provide an en hanced coverage that allow all physicians to have consistent coverage for hypertension patients not at goal BP as defined by JNC and are on a minimum of two antihypertensive medications.

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To whom it may concern:

I have been treating hypertension for 20+ years. I acquired an ICG hemodynamic capability in the form of BioZ. several years ago. It was purchased at the time for fine-tuning my treatment of hypertension as well as managing cardiomyopathies. Also at that time Medicare was covering for hypertension as a diagnosis under known or suspected cv disease. That coverage was discontinued but I had experience with Medicare patients and now have many more experience with other insurance companies and with ICG in general I began to use more ACE, ARB, CCB and less beta-blockers as a result of the ICG results for hypertensive patients. In highly comorbid populations as well as less comorbid, the ICG hemodynamics is invaluable in maintenance of long-term well-being.

It has been shown over and over that a proactive stance has significant financial benefits rather than having to react to problems that arise as a result of ineffective treatments. It is time for the CMS to utilize this philosophy in their decisions and I was surprised to hear that you do not consider cost-effectiveness in your coverage decisions. You need to strongly consider covering ICG for less than three drugs and your carrier discretion clause is just a means for noncoverage which does not make sense given the clinical effectiveness, RCT effectiveness and cost-effectiveness of ICG. It seems like there is something else that I am missing. Please explain.

Sincerely,
John D. Sutton, M.D.

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I have treated hypertension for 26 years and have come to believe that the use of the ICG technology has transformed my practice. I have a more objective approach to treating hypertension with respect to drug class. I feel the patients do better clinically with ICG and without ICG I am often confused that I have their cardiac outputs too low or SVRIs too high. ICG is a win for my hypertensive patients and needs coverage. The published data is credible and the Control trial shows that coverage should be extended to at least uncontrolled patients on multiple drugs (e.g. 2-3). It is unfair to have carrier discretion as it sets up unfair access to both patients and physicians.

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To Whom It May Concern,

My specialty is Family Practice and Emergency Medicine. I have been using the BioZ Impedance Cardiography (ICG) for the last 3 years and I have found it to be tremendously helpful in evaluating patients who are not controlled with 2 or more drugs. On the basis of the ICG we are able to select and adjust the most appropriate medication to get optimal blood pressure control and get a better understanding of pathophysiological mechanism of a particular patient's hypertension.

I feel Medicare's decision not to cover the evaluation of Arterial Hypertension with 3 drugs would reduce my ability to properly evaluate and treat this subgroup of patients. This will increase the number of visits a patient will have to make to my office as well as the cost of medication which may not be effective. Please take this into consideration in making your decision.

Thank you very much for taking time to consider my opinion on the need to continue coverage of the BioZ Impedance Cardiography (ICG) testing.

Sincerely
N. Janicijevic, M.D., F.A.C.E.P.
Medical Director
Medi-Help

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The Bio-Z machine machine is outstanding in the diagnosis of underlying HD parameters and selection of drugs for HTN. The machine should definitely be utilized earlier to help Drs quit guessing which HTN meds to use. This should be billable with patients in the use of 1-2 meds for high BP. JNC-7 suggests multiple drug use and the Bio-Z helps pick the correct meds earlier in the course of therapy. Due to the results from the Bio-Z, I now use more ACE inhibitors and ACE receptor blockers by evaluating a patient's systemic vascular resistance. This machine also helps in the over use of B-blockers, helps manage hypertension better and my patients feel better. CMS questions whether physicians actually use the HD data to change meds. The manuscript reported that patients with high SVRI received more ACEI, ARBs and Ca Ch Blockers and this happens in clinical practice also as I described above. I am disappointed with your proposed policy and believe there is ample evidence for expanded coverage for all states to cover hypertension patients uncontrolled on 2 or more meds.

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The Medical Device Manufacturers Association (MDMA) would like to offer our input regarding your proposed decision memo for thoracic electrical bioimpedance (TEB). MDMA has sought to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of innovative products in the marketplace.

We have been following the coverage process for TEB and are concerned that the "carrier discretion" policy that is being proposed to be maintained for resistant hypertension is essentially a "non coverage" policy. We have seen this policy treatment with other innovative technologies and believe it has the potential to harm healthcare innovation over time and adversely impact our country's healthcare standards. As you know, many new technologies are developed by smaller companies often with only one product line. For these companies, it is imperative that coverage decisions be made consistent with the merits of the science. Therefore, MDMA recommends that you develop a national coverage policy for hypertensive patients that takes into account all of the available scientific evidence, including recently published studies.

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I am a clinical cardiologist wishing to weigh in our your proposed policy and decision memo for electrical bioimpedance application for the management of hypertension. I have treated hypertension for 18 years and had grown frustrated with my inability to improve my overall patient population control rates. Although similar to national rates, I felt I should be doing better. Since augmenting my assessment and treatment with ICG, my control rates have risen significantly as well as patients feeling better on the prescribed pharmacologic regimen.

I would submit that the Mayo and Control randomized controlled trials are inherently high quality evidence due to the randomized, prospective nature, generalizable to the Medicare population and have considerable magnitude of benefit, both in short- and long-term, thus sufficient data. I do not believe the future trial design suggested by CMS in the decision memo is reflective of real-life application and therefore not as applicable as the currently available studies. Given the quality and applicability of these studies, I request that CMS consider national coverage for hypertensive patients uncontrolled on two or more antihypertensive medications.

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I have treated a wide range of hypertensive patients in the past 30 years and have found tremendous improvements in blood pressure control in the five years since I incorporated ICG in to hypertension management. I understand that for coverage we need published studies to validate clinical experience; consequently, I am confounded that CMS does not believe there is sufficient evidence for expanding coverage for ICG for hypertension. Your proposed policy references that RCTs are the highest ranking of research design and there are two RCTs for this ICG application, both of which demonstrate superior blood pressure reductions as compared to our standard methods of using national guidelines and/or subjective selection of therapy which is the equivalent of guesswork. Both studies met primary endpoints. Additionally, these ICG RCTs are generalizable to the Medicare population and have low risk with significant benefits. I can not believe that many can understand or support your conclusions.

The NCD for ICG for hypertension with contractor discretion has led to changing policies and frustration for practitioners subject to their policies. An NCD should not result in wide variation of policies as a result of medical directors with no experience treating patients with noninvasive hemodynamic data. I encourage CMS to reconsider its proposed policy to ensure coverage for uncontrolled hypertension is available for all their beneficiaries who are uncontrolled on two antihypertensive medications. Thank you for considering my concern for the well being of my patients.

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The information I obtain from BioZ ICG has been helpful in deciding how further to treat patients with hypertension. My experience is consistent with the randomized trials in published literature demonstrating ICG is instrumental in controlling BP for patients when standard clinical assessment, life style modifications and initial treatment on one or two antihypertensive medications does not resolve the hypertensive state. ICG data helps me optimize care for my patients and positively affected my choices of medications.

I do not agree with your assessment that subjects should be followed for a minimum of 6 months to measure the durability of their blood pressure control. As a nation, we can’t even get patients to initial control, so how can CMS hold ICG to an even higher standard when ICG significantly improves blood pressure reduction as compared to standard measures.

I practice in NY where our local contracted Medicare carrier does not allow Medicare beneficiaries access to ICG; therefore, our Medicare patients are deprived access to this important technology. At my own expense I will use it on Medicare patients whom I know will benefit and I am thankful I can use it on my private insurance patients. I respectfully request that you issue a policy ensuring contractors provide coverage for patients not at goal BP on two or more antihypertensive medications.

Lee Root, M.D. F.A.C.C.

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Thank you for considering the clinical experience of clinicians who have incorporated ICG technology into their hypertension management. I am not surprised to read the confirmations that physicians' clinical experience supports the randomized trial results and that these physicians value the knowledge of a patient's fluid levels, CI, and SVRI for the selection and dosing of antihypertensive drugs. The results are indisputable in terms of blood pressure reduction and improved outcomes. CMS analysis raised several questions regarding the Control trial, which in itself is a natural outcome of any analysis, but certainly does not invalidate the results.

With U.S. hypertension control rates extremely low, proven poor outcomes for uncontrolled hypertensive patients, and prevalence of obesity, the proven benefits of individualized hypertensive therapy based on ICG hemodynamic parameters deserve greater consideration from CMS. I request that CMS clarify any misunderstandings and provide a national coverage policy (eliminating the local contractor discretion) for patients not at goal blood pressure despite education on lifestyle modification and initial pharmacologic therapy with two or more drugs. Thank you for your consideration,

Lawrence Deck, III, M.D., F.A.C.P.

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Thank you for the opportunity to comment on your draft policy for ICG for hypertension. I have utilized ICG in my practice for over 5 years in the diagnosis and treatment of hypertension and it has contributed considerably to my ability to control hypertension through improved ability to understand the underlying hemodynamic abnormality causing the increased blood pressure. With ICG data, I can more accurately select and titrate my antihypertensive drugs, proven through increased blood pressure control rates. It is unfortunate that my Medicare hypertensive patients are not covered as a result of the "contractor discretion" policy and the decision of our local contractor in New Jersey not to cover ICG for hypertension.

Over the past several years, there have been a number of publications and presentations at national meetings on the value of hemodynamics in the areas of diagnostic prognostic and therapeutic monitoring, including two randomized controlled trials, Mayo Clinic (Hypertension 2002) and CONTROL (Hypertension 2006). Both of these studies demonstrated statistically significant results in patients reaching target blood pressure of < 140/90. These are well accepted primary endpoints in the highest level of study design. Given the study design and results, I am flummoxed by your draft decision and conclusion that there is insufficient evidence. Additionally, given this level of evidence, it is not logical for CMS to require contractor discretion. I exhort you to objectively develop a decision that reflects this quality data. My recommendation would be a national policy covered by all contractors allowing ICG utilization on patients that have received lifestyle modification education and treatment with a minimum of two antihypertensive medications for a minimum period of time allowing therapeutic effects, e.g. 30 days for each medication

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I've treated hypertension for approximately 25 years and have found the BioZ ICG to be a very important adjunct to my assessment, diagnosis of the underlying homodynamic abnormalities and guidance of my selection of antihypertensive meds. By more aggressive management, through ICG assessment and guided-treatment, we are achieving improved blood pressure control and are able to decrease the incidence of hospital admissions and ultimately decreasing morbidity and mortality, including MI and strokes. It would be helpful to have CMS reanalyze the data, accept the outcomes of reduced blood pressure which is demonstrably evident in the two ICG randomized trials and have provision for a NCD for hypertensive patients not responsive to counseling on lifestyle modifications and initial two drug therapy.

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ICG provides me with a total homodynamic profile that is invaluable in managing my hypertensive patients. I encourage CMS to consider results-guided medicine and accept that the randomized trials are designed to minimize concerns such as those raised in CMS analysis. The only difference between the 2 groups in the Control and Mayo clinic trials, are the presence if ICG. That is the same for our practice. We get better results when we have the presence of ICG when treating our hypertensive patients. We follow the algorithm most of the time, but sometimes there are patient factors that may cause us to consider the data but deviate from the algorithm. This is real life medicine. ICG is a win-win situation for CMS, patients and providers in that ICG allows us to more quickly achieve target blood pressure, thereby reducing office visits, minimizing medication does increases/decreases and changes in meds, enhancing patient's well being, minimizing side effects, and longer term, reducing the progression of advances CV disease. Thank you for consideration of a national policy, as we currently do not have coverage for our hypertensive patients and also allow coverage for hypertensive patients remaining uncontrolled on two or three medications.

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I have found ICG by BioZ to be essential in successful and accurate medication control of patients with hypertension. I utilize it because it leads to more rapid control via better choice of medications for my hypertensive patients and as a consequence, it is also a cost- savings tool. The recent Control trial bears out these same results and validates the clinical experience of physicians in a randomized controlled trial that is difficult to objectively question. Our practice encourages CMS to find a means of ensuring Medicare hypertensive patients can benefit from this effective advancement in hypertension care. We find utility on our private insurance patients that have not responded to diet, exercise, etc and to one or two medications and believe the research support this but we think a national policy on three drugs would benefit the majority better than a contractor discretion on less drugs as we have witnessed that there can be irrational changes in their contractor coverage.

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Our practice specializes in noninvasive cardiology treatment and I have personally treated hypertension for over 20 years. As basic as one would imagine hypertension would be to treat, our national control rates indicate that all of us have significant need for additional effective measures. ICG offers the solution and it has been frustrating to practice in Texas where our Medicare contractor has prohibited the reimbursement for hypertension. My management with ICG for hypertension is the same as the algorithms utilized in the RCTs (Control and Mayo) with similar outcomes in terms of percentages of patients controlled. This is the most significant improvement in the control of hypertension and far outweighs the control results we have experienced with the JNC guidelines. Please allow this important advancement to be used for all your beneficiaries and the only means to ensure this is to eliminate the contractor discretion language. CMS will have cost-effectiveness as a result of ICG utilization for hypertension patients uncontrolled on two or more drugs. Thank you for the opportunity to comment.

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CMS re ICG hypertension proposed policy Our cardiology practice and patients have been challenged and severely hurt by the current and proposed "contractor discretion" language in the policy for hypertension coverage for ICG. Our local contractor, Trailblazers (THE), has long not allowed the coverage of ICG for hypertension. We are providing inferior care to our Medicare patients because of Trailblazers' position and Medicare's allowance of contractor discretion. Our private pay patients are fortunate because we are able to use ICG to assess, select and dose the medications. We have better outcomes in blood pressure reductions and control when we utilize ICG. We do not use on every hypertensive patient but we reserve for those patients that have not be controlled with lifestyle changes/counseling and initial pharma therapy.

Our clinical practice is very similar to the results of the randomized trials which show improved outcomes through lower blood pressure. It is widely accepted that lowering blood pressure leads to reduced development of advanced cardiovascular disease including myocardial infarcts, strokes and CHF. We do not believe CMS should have concerns with the trial design of CONTROL or Mayo clinic as both are randomized trials which are inherently designed to eliminate/minimize systematic bias and due to the prospective nature, the studies ensure a thorough and systematical assessment of factors related to outcomes. Both CONTROL and Mayo studies provide sufficient evidence for expanding ICG coverage to a national coverage policy for patients not responding to 2 or 3 medications.

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CMS: re ICG hypertension coverageOur cardiology practice has treated hypertension for 20 years and have noticed considerable improvements in our hypertensive control since incorporating ICG into our clinical assessment and selection of treatment. We have gone through numerous JNC guidelines all failing to reduce national hypertension rates, as well as our practice's control rates. With ICG-directed management, the process is objective and based on hemodynamic data which is logical as SVR and CO actually comprise BP.

Our practice believes there is enough evidence in the two ICG RCTs, which are regarded as the most pristine research study design. Please re-evaluate the current data and seek clarification during this process. We would suggest you consider a coverage decision for hypertensive patients on 2 or more antihypertensive medications that is not contractor discretion. That would just mean noncoverage. Thank you for seeking feedback on your proposed memo.

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Electrical bioimpedance has considerably improved the care and control of my hypertensive patients by providing hemodynamic data that allows me to objectively direct therapy. I was concerned with CMS analysis in that it seems to focus on secondary concerns of the CONTROL trial evidence vs. acknowledging that the primary endpoint of BP control was statistically significantly better in the electrical bioimpedance arm as compared to standard care arm. The difference in the two arms was the availability of electrical bioimpedance. This was the second randomized controlled trial showing electrical bioimpedance to be better than standard care and should be more than sufficient evidence to provide for an improved policy with a national coverage decision for use in patients uncontrolled on two or more meds. I also encourage you to listen to your physicians that are providing you with every day clinical experience/benefits of electrical bioimpedance.

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TO WHOM IT MAY CONCERN,

We have significant crises across our healthcare system and I was sorry to see that CMS did not feel there was sufficient data to expand ICG coverage for hypertension. I am confident there are economic concerns over expansion of any technology for treatment of such a prevalent condition as hypertension. The sad fact facing our nation is that we have atrociously low control rates for hypertension and it is exacerbated for patients over 60 years of age. This is alarming for many reasons, including the fact that we are now beginning to pay for hypertensive medications under Part D. The worse fact is that left untreated, these patients will develop more costly cardiovascular diseases.

It is well recognized that hypertension is an imbalance of hemodynamic forces, usually characterized by elevated vascular resistance, cardiac output or both. It is logical that ICG which provides data on the components of blood pressure would be effective in hypertension treatment. The logic is verified by two randomized controlled trials that statistically showed superior blood pressure reduction in ICG groups over standard care group. Blood pressure reduction to < 140/90 mm Hg was the primary endpoint-that's it. Mechanisms, algorithm compliance, logic, med compliance, etc. are not endpoints in the Control trial and, beyond good scientific critique that always raises additional questions, these criteria DO NOT invalidate the primary endpoint results.

Based on the achievement of primary endpoints of statistically significant lowering of BP to < 140/90, I recommend there is sufficient evidence to nationally cover patients for ICG not at goal blood pressure after initial attempts with modifications in lifestyle and two or more antihypertensive medications.

With gratitude for your consideration
Anu Chirala, MD , FACC

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Centers for Medicare and Medicaid,

I do not understand the rationale of your proposed decision for ICG for hypertension management. I have treated hypertension for over 20 years and based on my experience with ICG, I confirm that my clinical practice supports the RCT results of the Control and Mayo Clinic trials. Anyone who has utilized ICG in clinical practice will attest to the value of knowing the status of a patient's cardiac index, systemic vascular resistance index and fluid levels for the selection and titration of antihypertensive drugs. The basic algorithmic mechanism of ICQ is:

1. If systemic vascular resistance is high, then initiate or up titrate an ACE, ARAB or COB;

2. If cardiac index is high, then initiate or up titrate B-blocker; conversely if low, decrease dose of B-blocker.

3. If visit to visit fluid levels are increasing or not decreasing, then initiate or up titrate diuretic.

With national hypertension control rates unacceptably low, decidedly poor outcomes for uncontrolled hypertensive patients (progressing to advanced cardiovascular disease), prevalence of obesity with average BMIs in excess of 32, and increasing incidence of diabetes, the RAT-proven ICQ concept of individualizing hypertensive therapy based on homodynamic parameters should be given merit and justifies broader CMS coverage.

I would request that CMS reconsider the newly published clinical data on less resistant hypertensive patients and also consider the comments of physicians. This is a low-cost test ($45) that has the published evidence and clinical practice support deserving of a national coverage policy for hypertensive patients not responding to lifestyle modifications and initial pharmacologic therapy of a maximum of two drugs. Thank you for your help in this matter.

Sincerely, C. Michael Wright, MD, FACC

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I am writing in disappointment with the proposed ICG policy for hypertension. I understand CMS challenges with rising health costs but believe we must not be shortsighted when evaluating inexpensive, low risk technologies, like ICG, that have data demonstrating clinical and cost effectiveness in a serious problem like hypertension.

NHANES data in 2004 reported that prevalence, control and awareness rates for hypertension are worse for persons over 60 years as compared to the general population and that hypertension is a serious problem of low awareness and inadequate management. ICG has demonstrated through the two randomized trials and additional data to help patients understand hypertension treatment (why the MD is prescribing certain meds) and assist physicians to more adequately control blood pressure through ICG-assisted therapy. Even if physicians do not follow the ICG algorithm 100% of the time, or even 50% of the time, what does it matter? What guideline or algorithm do we ever follow 100% of the time? Algorithms and guidelines are additional consideration, guidance; not mandated adherence. If mandated compliance was expected, there would be no need for physicians and medical schools. Furthermore, the FDA would never approve a mandated algorithm or mandated management on a device. Imagine if we took interpretive ECGs data at face value 100% of the time. It just does not work that way. There are numerous patient considerations and all adjunctive data from diagnostic and monitoring tests are just part of the puzzle.

I encourage CMS to find a method for amending coverage to allow for a uniform policy that allows all Medicare patients access to this test, especially if our government/tax payers are paying for meds under Part D. A national policy for patients uncontrolled on two or three meds would be justifiable given the current evidence. We are do a disservice to all if we do not extend this policy to more patients in a uniform manner. Thank you,

Mike Arsov, MD, FACC

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Re CMS Proposal for Electrical bioimpedance hypertension coverageIt seems like the standards for getting CMS coverage/expansion for less expensive, helpful, no risk technologies like electrical bioimpedance are tougher than more expensive tests like t-wave alternans and ambulatory blood pressure monitoring. Neither of the latter two had randomized trials for evidence like electrical bioimpedance.

I am confounded by the logic of insufficient evidence. CMS criticism that lack of information about the number of physicians in the HC (electrical bioimpedance ) group actually using hemodynamic data is a critical omission. I do not agree with this as this was not a stated outcome and the stated outcomes were achieved, namely greater blood pressure reductions in the electrical bioimpedance group as compared to standard care group. Just like we don't always follow guidelines, we use our clinical judgment in making decisions on whether to use any particular data given the patient condition and different circumstances. It is well accepted that lower blood pressure reduces CV morbidity and mortality. I request that you not hold electrical bioimpedance to a standard higher than other recently covered technologies when in fact there is better data from randomized trials and provide for coverage on less than three drugs with a national coverage decision so we can assure fair coverage. This test will save money and lives.

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Centers for Medicare and Medicaid
I am sorry to read that you are not suggesting to extend hypertension coverage for ICG to less resistant hypertensive patients. I practice in Mississippi where hypertension is rampant and patients would benefit with earlier BP control by 6-12 months if they could have earlier access to ICG. CMS also expends money on 6-12 additional office visits as we try monthly to get these patients under control. Because we often guess at the wrong meds, patients probably do not take their meds as much as they should and/or because the are on the wrong class of drugs due to our guessing and not responding, it is just a waste. As a tax payer and physician, I ask you to have a national policy that allows ICG use on patients uncontrolled on less than three meds. Thank you for obtaining guidance on this decision.

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On behalf of our internal medicine practice, we wish to comment that we are discouraged and confused that CMS could not find sufficient evidence within the two randomized controlled trials (RCTs) in which the Control ICG RCT trial validated the results of the Mayo clinic RCT and in fact demonstrated twice as good blood pressure reduction as compared to standard care group on patients uncontrolled on e one to three medications. These results are precisely what the authors of the Mayo trial theorized in its conclusion: that general practitioners could achieve even better results with ICG as compared to specialists.

As CMS points out in the proposed decision memo (Appendix A, Methodological Principles of Study Design) RCTs are ranked as the HIGHEST quality of study design. It is confusing why you would not only say that the two RCTs are not sufficient evidence but go on to suggest that ICG should undergo another trial in which your suggested design would be judged as inferior to a RCT. Many refer to CMS suggested design as a "poor man's RCT" because it is not equivalent to a pure RCT but strives to do the same with for less money.

We respectfully request that you reconsider the quality of these trial designs as well as the results and grant a national coverage decision for the management of hypertensive patients on two or more antihypertensive drugs who are not at the specific patient's goal blood pressure. We are grateful for your consideration,

William E. Jones, M.D.

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I treat various patients in my practice and want you to know that the ICG test has been one of the most valuable for cardiac patients, especially hypertension. It is difficult to not be able to use this data on my Medicare patients that I know would benefit. Sometime I just absorb the cost of the disposable and tech/my time as I want to provide my patients the best care I can and I know I can get to the best answer with ICG. Many of my patients complain of side effects of antihypertensive and those I treat with ICG feel better than those I can not. Based on the comments of many practitioners and the published studies, I want to request that you consider a national policy that requires states to cover for uncontrolled hypertensive patients on two or more drugs. Even three drug would be better than contractor discretion and benefit more patients who truly need help.

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ICG has been the best development in treatment of hypertension and hopefully your final policy will reflect the physician users experience along with the clinical trials that has been scrutinized by experts at national hypertension meetings and the journals in which they were published. We have had great success with ICG as many of my colleagues have. Now we just need Medicare to understand this is an inexpensive test that helps patients. It also helps reduce the overall burden to our healthcare system by reducing excessive drug costs and development of more serous disease. NY contractor does not allow and I am in support of a national type coverage that will allow use on my patients that I have not been able to control with initial attempts. I thank you for your consideration of my experience and request.

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ICG has proven very helpful in our selection and titration of antihypertensive meds. Our control rates have improved to a level very similar to those reported in the manuscripts from the hypertension journal. We are impressed by the applicability of the ICG data and are not sure how we practiced without it. Frankly, we are doing a poor job at controlling hypertension in the US and ICG has truly helped. Unfortunately, your proposed policy does not support a policy that will ensure our coverage as contractors can decide to cover or not and we all know what that means. I support that there is statistically significant evidence in two different studies to allow use on patients uncontrolled on less than three drugs.

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Thank you for the opportunity to comment on your proposed decision for electrical bioimpedance coverage for hypertension. Although disappointed, I understand Medicare's need to control costs. I would submit that there is sufficient evidence in the two RCTs to provide a national policy for patients uncontrolled on two or three medications. Medicare will truly save more money if they allowed coverage on two medications as these patients will be controlled more quickly with less office visits and prescription costs. Electrical bioimpedance has proven to reduce blood pressure more effectively than our tried methods and should be given opportunity to help more patients. I request a national policy because of contractor in Pennsylvania has vacillated between coverage and no coverage a few times and it is frustrating and a waste of time for all. Most importantly, we would like to be able to use this important technology on our patients, Medicare and otherwise.

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I was disappointed to read your proposed decision on hypertension for ICG. I practice in New Jersey where the Medicare contractor does not allow for coverage. Our contractors are incented to control costs so a contractor discretion decision basically ensures non coverage. I request at a minimum that you provide a national coverage decision that allows use of ICG for patients not responding to three drugs. The diuretic requirement is not always appropriate. I am surprised that your coverage team does not agree there is evidence for less than three drugs. A workable policy which would be beneficial to patients and providers while being manageable by Medicare would be to allow usage on patients that cannot be controlled on two medications after three or four months of treatment and failure with initial pharmaceutical attempts and changes in lifestyle. Thank you.

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Dear CMS Coverage,I am a cardiologist who has practiced for 20 years and treat thousands of patients in my practice, a large percentage of them are Medicare beneficiaries. I have read with disappointment the draft coverage decision on TEB from CMS. It is a technology that has helped me in my practice reduce trial and error prescribing for high BP, shortened the period necessary for me to get patients to goal BP, and given my patients positive reasons to comply with their meds and the lifestyle changes I have recommended.

Over the past several years, CMS, the manufacturers of this technology and providers have struggled to find a common ground about this technology and its use and value to practitioners and beneficiaries. I believe this long running challenge/dispute has possibly caused each to lose sight of the patient and the physician focus, inappropriately, just on winning the argument. Has the long debate over research and evidence blinded each to what the patient and physician needs are? This is not about winning a debate or selling a machine or extracting revenge for a public slight. It is about making available to physicians in certain special and unusual circumstances a technology to make available scientific measures that would facilitate improved patient management of uncontrolled BP.

I am concerned that CMS has rejected the coverage expansion request from the company so categorically that it has missed an opportunity to improve upon the current coverage based on the new evidence coming from the Control trial. The choices are not just to approve or disapprove of the manufacturer's request. The intelligent and courageous thing to do is to fashion a coverage decision that recognizes the clinical utility of this test and approves it for certain uses in light of the new clinical evidence without opening up the Medicare program to excessively broad and expansive uses of the technology not justified by the evidence. We are losing the battle against the epidemic of hypertension and I fear that ignoring the value of this technology so completely will raise yet another barrier to BP control.

The focus of the proposed decision is upon criticizing the design of the Control trial rather than studying what the achievement of its endpoints means for improving BP control in the US. Methodological purity and integrity are important. Scientific certainty is a wonderful objective. But a study does not have to be perfect to be instructive and valuable. There is not a single sentence in the draft memorandum that describes achievement of the study's endpoints, if plausible, as a public health positive or a net health improvement. No where does the memorandum attempt to explain how the study achieved its endpoints. Instead, the entire document questions and denigrates the design and conduct of the trial and raises almost endless possibilities of why the trial is misleading, improbable, and not useful.

There is not one physician or academician who has expressed reservations or raised questions about the Control trial. So far I have not read one public comment supporting CMS proposed decision. There were only 3 to 4 objections to the request among the initial public comments and the main one was from a retired/disgruntled employee of CMS who appeared to have participated in the fist reconsideration decision and is intent on keeping it in place, no matter the evidence. I have not seen one clinical trial that asserts or proves the absence of clinical utility of TEB. Thank you for taking another look at the evidence and working creatively to modify the current policy in a defensible and responsible way. My colleagues and your beneficiaries will appreciate your efforts and I think we will start to make some progress in HTN control. Certainly a national policy for patients who have failed to reach target BP after lifestyle modifications and initial therapy up two medications would be reasonable candidates for TEB.

Sincerely,David A. Clark, MD, FACC

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am a certified physician assistant and have had the opportunity to work under a physician in a cardiology practice that has successfully utilized ICG in the treatment hypertensive patients. Over the last five years as we have implemented ICG into our care, we have witnessed a growing percentage of our difficult to control patients become very stable and controlled. In our practice, we attempt to control referred patients or newly diagnosed patients with diet, exercise and one drug or combination therapy. Only after failure on this regimen which is about 3 office visits, then we use ICG. Many times we find that we need to stop one agent and add another hemodynamic affecting class or are given validation we need to add another agent to further lower vascular resistance. ICG minimizing our guessing and give real objective data. It is helpful to have a standardized policy applicable to all practices and hopefully you can further consider the clinical experience and data and improve the coverage for hypertension.

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I am commenting in support of a more expansive coverage policy for ICG and believe there is credible, ample evidence for a national policy on patients not at goal blood pressure. Although CMS is asking for additional evidence, we need to consider the two randomized trials and professional experience of ICG users. We don't do a $40 test to make money. ICG is not worth our time if it is monetarily motivated. ICG truly helps us in the control of hypertension. Many of these patients feel poorly on their medications prescribed with trial and error yet through individualized therapy prescription with ICG they feel much better and stay controlled. We are spending billions of dollars on healthcare and in excess of $60 billion on hypertension treatment alone. It is crazy not to allow a noninvasive, safe, $40 test that has proven to be better than our current methods. Cut out some of the more expensive cardiology procedures in favor of a treatment which will prevent or slow the progression of cardiovascular disease through more efficient high blood pressure control.

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ICG has been instrumental in helping me control my hypertensive patients. I practice in Florida where we had a policy allowing us to use ICG on uncontrolled patients regardless of the # of medications, then it changes to three or more drugs. I realize we need to rein healthcare costs and support intelligent application of that principle. ICG was very helpful on my patients that were not controlled with modifications to drinking, diet, smoking etc. and monotherapy. I still can use it on private pay patient under this scenario and use it with no compensation on Medicare patients that I know will benefit from it. I am sure many practices will not use ICG at a loss and many Medicare patients are remaining uncontrolled. This is costing us more money as disease is progressing and if these patients on starting Part D coverage, then we will have increased drug cost. I would be hopeful you could consider a compromise with a policy allowing for patients unresponsive on two or more drugs. I would recommend you delete the diuretic requirement as some patients can not tolerate a diuretic and also ensure that we do not have Medicare contractor discretion. Feel free to contact me if you have questions,

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Dear CMS,I have practice internal medicine and treated hypertension for over 20 years. ICG use has greatly improved my approach to blood pressure control for the past 5 years. I use the fluid parameter to titrate diuretics, SVRI to titrate ARBs/ACEI/ Ca Ch blockers and CO to titrate beta-blockers and reach target blood pressure on less office visits than it used to require. I know that many of my patients are leading a higher quality of life due to ICG and we have prevented their uncontrolled blood pressure leading to additional morbidity. ICG has been useful on hypertensive patients of all ages and has never cause problems that would be considered a risk. ICG has the potential to benefit many more Medicare patients and I implore you to conclude that the two randomized trials reviewed and approved by hypertension experts in the peer review publication process are indeed sufficient evidence to implement a national policy for patients uncontrolled on two antihypertensive medications.

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RE ICG coverage for hypertension
Blood pressure reductions are proven to improve patient outcomes through reduced morbidity and mortality associated with cardiovascular disease. ICG has shown in two randomized controlled studies to reduce blood pressure at no risk on a multitude of patients with varying degrees of uncontrolled hypertension. CMS has a heavy task to weigh through all the evidence. I ask that you use the same level of criteria for all of your decisions. I do not understand why ABP monitoring which has no randomized trials that I know of received coverage yet ICG with prospective studies utilizing research design that minimizes systematic bias would be considered insufficient evidence for a national policy comparable to ABP monitoring. The Smith et al study also shows that ICG is effective for patients with high blood pressure on 3, 2 or 1 medication. It would be justified to allow coverage on patients treated with 2 drugs and still not at goal. My experience with ICG mirrors that of the two randomized studies.

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I understand you are requesting comments for electrical bioimpedance as you finalize your decision for hypertension coverage. I entirely support expanded coverage and was discouraged by your proposed decision. I have reviewed your proposed decision memo and believe many of your comments/questions are covered in the published trial manuscript or miss the point of the trial.

To point out a few in your summary: Your comment on the authors offering no explanation for the 3:2 ratio of patients in the standard care group vs. ICG group is addressed under statistical analysis section of the published manuscript and was due to expected heterogeneity in the standard arm; next your comment on authors reporting generalized info on how hemodynamic data was used vs. specific information, the CONTROL study proposed treatment strategy for the experimental group is clearly stated by your report. Everyone would agree that regardless of the individual treatment strategy, which can never be consistent unless you remove the physician from the picture, that blood pressure reduction is the key element. Even if everyone followed the exact strategy, if BP was not reduced, no one would care. We should be focused on the outcome of blood pressure reduction which was clearly demonstrated in the Control and Mayo clinic studies. Lastly, these trials are randomized controlled trials which your report points out are the highest ranking in research design.

There is sufficient evidence to provide expanded coverage. In the state of NY where I practice electrical bioimpedance use for hypertension is not allowed by the contractor. Do the right thing and give a nationalized policy for patients not responding to less than 3 drugs, even a limitation of 2 drugs would be more reflective of the provided evidence. I appreciate your review and consideration of this important technology.

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To Whom It May Concern:Hypertension control has proven to be elusive for the most advanced healthcare system in the world. As you correctly note, 27% of adult Americans have hypertension and 70% of patients under treatment are not controlled. With statistics like this, we need to utilize different approaches. From my perspective, there is considerable evidence to support the use of ICG in hypertension. We have two randomized controlled trials that have undergone peer review by independent specialists prior to publication. Both of these trials were also presented at national hypertension meetings. Hemodynamic assessment for selection of hemodynamic acting drugs is intuitive and more than intuitive have demonstrated in two trials to have improved blood pressure control over our regular means of using national JNC guidelines or ignoring the guideline and providing our favorite antihypertensive medication. It is important that physicians are allowed to use ICG to better treat Medicare patients and prevent end organ damage resulting from uncontrolled hypertension. Given this evidence, I ask that you reconsider your proposed decision and allow national coverage for management of hypertensive patients on two or more antihypertensive drugs who are not at goal blood pressure after three months of treatment with a minimum of 2 drugs and lifestyle modifications. This represent an improvement of coverage based on evidence but is still a policy that will not encourage abuse of ICG. Your reconsideration will benefit beneficiaries, CMS and physicians.

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Regarding Proposed Decision Memo for Electrical bioimpedance (TEB)
Given that decreases in blood pressure are validated to improve outcomes, that our control rates in the US are very low, and TEB has shown now in two randomized studies to produce significantly better blood pressure lowering compared to our guidelines and standard methods, I can not understand why Medicare would not encourage appropriate use of this low cost, low risk test. TEB has reduced the number of visits and drug changes that it takes to control hypertensive patients in my practice, very much like the Mayo and Control trials. Because I practice in NY and the policy is currently contractor discretion, I can only use TEB for private insurance patients for hypertension or forego reimbursement in Medicare patients. I think it would save Medicare morbidity costs at a very low test price to allow TEB to be covered by all carriers for patients that are not responding to recommended changes in diet, health and a minimum of two antihypertensive medications. Please reconsider your decision.

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I am commenting on CMS proposed decision for ICG for hypertension. I was disappointed by the CMS analysis and summary decision given that the ICG evidence is from RCTs (the highest methodology for clinical trial design), ICG directed care produced statistically significant results over standard care (which is not so standard), proven long term benefits of lowering blood pressure (as little as 2mm reduction translates to 10% reduction in strokes; the CONTROL study had reductions of 8/7 mm HG in systolic/diastolic), and experience of physicians using ICG. Your may want to reconsider the data, results, and our history of coverage for diagnostic tests. This test has more evidence than many tests we use daily in our clinical care. ICG has clearly demonstrated to be effective at blood pressure control on a wide range of patients, including age, morbidity and length of time uncontrolled/# of medications. This has been proven in RCTs and in many physicians personal practices. I support there is sufficient evidence for at least a national coverage decision for uncontrolled patients on 2 or more drugs.

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Re: Hypertension coverage for electrical bioimpedanceBased on two randomized controlled study results, and personal clinical experience, I support an expanded hypertension coverage policy for electrical bioimpedance. It is well known that controlled blood pressure reduces cardiovascular morbidity and mortality. The randomized trials are credible evidence critiqued by hypertension experts who conduct peer reviews who would not allow publications if the studies had considerable flaws. The trials clearly show that electrical bioimpedance has more significant reductions in blood pressure when compared to our conventional methods of basically guessing which antihypertensive meds to provide. Electrical bioimpedance has no risks, the results are generalizable to the medicare population and should be given expanded coverage.

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CMS, I would request that you take into account the clinical utility TEB has given to your providers and also the randomized controlled trials demonstrating TEB to be more effective than our standard methods at blood pressure control. TEB has improved my blood pressure control on patients after initial attempts of lifestyle changes and 1 or 2 drugs have failed. Medicare patients are currently not receiving optimal hypertensive care and will continue to be denied optimal care if you do not change your proposed policy does to include mandated contractor coverage on patients still not at goal bp after attempts of lifestyle change and one or two drugs have failed.

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In the time I have used TEB, I have been able to significantly improve the control rates of my hypertensive patients by using the TEB data to determine the appropriate class of medication and subsequent titration. I have utilized the same mechanisms described in the CONTROL and Mayo trials and have has increasingly improved control rates along with less frequent patient complaints of medication side-effects. I support and urge CMS to make its policy more broad so more Medicare patients can benefit from faster control rates and less drug changes. The evidence is certainly sufficient for a nationalized policy allowing treatment of patients not controlled on two or more drugs.

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I am a FP, 20 years experience treating hypertension. The 2 years experience w/ ICG has been very helpful for my patients. I do not feel it is appropriate that MC is denying expanding coverage. Besides the positive randomized trials showing sufficient evidence, many providers have found it useful in achieving goal bp more rationally and with less adverse effects. The evidence supports coverage for hypertensive patients not at goal bp on less than 3 drugs. Use of carrier discretion language will continue to result in unfair/non-uniform access for medicare patients.

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CMS, Over a three year period, ICG has been a tremendous asset in our ability to proactively treat hypertensive patients. We can make changes in the use of ACE, ARBs or calcium channel blockers depending on what is found on the ICG. In fact, it has enabled us to improve quality of life on many of these people, and in some, we have been able to prevent hospitalizations. We would submit that this is a very valuable tool for us to control our patients in a much better manner on an outpatinet basis. I would encourage the government to have a non-carrier discretion/national coverage decision that enables treatment of hypertensive patients uncontrolled on two or at most three medications.

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I have seen a number of patients being treated for hypertension that just "did not feel well" on the medication. In several of these patients, the BioZ assessment revealed data that allowed me to titrate or discontinue certain classes of meds and increase or adjust others and over a few visits we were able to control the patient's BP and they felt much better on the selected medications. In all, BioZ has helped me better control my hypertensive patients in less office visits than when I did not use the BioZ. I also have less does increases, decreases and changes in meds when I use BioZ. It would make good sense for Medicare to have a policy that allows all Medicare patients to be controlled with BioZ if they have not responded to initial treatment. Since you did not support the request for use on uncontrolled patients on 1 or more drugs, possibly consider use on uncontrolled patients on 2 or more drugs.

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Cardiodynamics ICG has helped us significantly in optimization of patients with hypertension and LV dysfunction including medication adjustment and improving clinical status. We request CMS ensure all policies are consistent through a national coverage decision for hypertension. If you are concerned with the potential amount of testing, testing could be restricted to patients who have failed to reach BP control after initial attempts with lifestyle changes and two antihypertensive medications.

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This helps in diagnosing the cause of hypertension and in selecting the appropriate antihypertensive medications. ICG is effective selecting treatment, following progress of treatment, directing additional treatment and has assisted in my patient population achieving control rates greater than 77%. The randomized studies had control rates much better than standard care, are definitely applicable to the Medicare population and should be sufficient evidence to allow a national policy for patients not responding to 2 or 3 antihypertensive medications. Please consider this type of policy. thank you,

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I am a Family Medicine specialist in private practice for 15 years. I have been using the BioZ impedance cardiography (ICG) for about 3 years and have found it very helpful in managing the hypertensive patient. However, it is underused in my practice because of reimbursement issues. I cannot do the tests on everyone that needs it because the sensors are expensive and this is not an expense my practice can afford. I think that Medicare’s decision for no-change in coverage regarding the ICG is inappropriate because studies show that this is an effective tool in managing hypertension. In one study there was a 35% improvement in BP control when compared to standard management. In the same study, the BioZ gave direction as to what medication is better suited for a particular patient. Our medical training tells us to use medications in a stratified manner in certain patient types. The BioZ will allow us to discern what patients will have better responses to medications that are further down the line in the stratified system, thus allowing physicians to control blood pressure more efficiently. ICG caused a difference in medication class and dose selection because the study showed greater use of vasodilators when SVRI was high, greater use of ARBs at final visit, less use of beta blockers when CI was normal or low, less dosage of thiazide diuretics and fewer dose increases and decreases in all medications. Medicare questioned whether a three month study period is long enough to determine if ICG was effective. The ICG study was able to obtain a 77% BP control rate in previously uncontrolled hypertensives in only three months. This is much less time than it usually takes to get blood pressure under control. A subgroup analysis of the CONTROL trial showed ICG maintained superiority in older patients thereby proving that Medicare’s question whether the CONTROL trial patients were reflective of the Medicare population was invalid. Also, the Mayo Clinic trial showed ICG’s benefit in a highly co-morbid population such as seen in Medicare patients. In summary, I believe that ICG should be approved for hypertension because it allows better control of hypertension thus decreasing morbidity and cost in the long run.

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I find that, in many hypertensive patients, that the ICG helps guide my treatment by identifying that aspect of hemodynamic profile that needs adjustment. Knowing volume guides diuretics. Knowing CO helps with Beta Blockers and knowing SVR guides therapy with ACEI/ARBS/CA blockers. Intelligent use of antihypertensives requires hemodynamic information-otherwise your just guessing! Do we really want to guess when we have noninvasive technology that can guide us? ICG guides hypertension treatment in an efficient manner that will save Medicare money in the short run by reducing office visits to control hypertension and reducing misprescribed medications and in the longer run by reducing hospitalizations due to heart failure, strokes and ischemic heart attacks as a result of uncontrolled hypertension. We will all benefit from a national Medicare policy that allows patients not controlled on two or more antihypertensive drugs.

James Croom, M.D.
Burnett Croom Lincoln Paden, L.L.C.

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Impedance cardiography (ICG) has been very useful in treating hypertension and I have found that it especially helpful on those patients not responding to two or more medications. Our practice's challenge with the current Medicare policy is that it is carrier discretion and because our Medicare contractor, Trailblazers, will not cover ICG for hypertension, our Medicare patients with hypertension have not benefited from ICG. Please ensure that your policy applies to all Medicare contractors and provide for coverage on patients not responding to two or three medications. Thank you for taking our comments into consideration. Robert A. Weiss, MD

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I find that TEB is helpful is directing my medication selection and titration when treating hypertension. TEB eliminates much of the guessing I previously did when treating hypertensive patients and minimizes side effects resulting from medications that should not have been prescribed. For example, if I had selected a beta blocker before sometimes it would result in the patient feeling too fatigued. Now I realize that many times I was trying to prescribe a beta blocker which was actually reducing the cardiac output too low when indeed I needed to be prescribing an ACEI or ARB to reduce the vascular resistance. TEB objectifies the drug selection. My experience is very much like that described in the CONTROL and mayo clinic trials. I respectfully request that CMS find a fair method to allow uniform coverage for medicare patients to be treated on two or three medications. Thank you,Curtis Bazemore, MD

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In my 25 years of treating hypertension, I have tried many approaches to improve my BP control. The National guidelines have continued to change due to lack of success. I would like you to know that ICG has been more helpful than any approach I have tried and has resulted in improved BP control rates in my patients. Please consider the randomized control trials and expand your hypertension coverage so ICG can be used on patients uncontrolled on less than three antihypertensive medications.

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I have used TEB for the last four years to augment the treatment of my hypertensive patients. TEB has helped considerably to streamline the time it takes to have my patients achieve target blood pressure. My patients also have less complaint related to side effects. I think Medicare could save money on reduced office visits due to getting patients to target blood pressure more quickly and also save on Part D. I use the same algorithms described in the randomized trials and have found similar results although I can only use TEB for my Medicare patients that are on 3 or more meds. I would like to see a policy that allows use of TEB on patients uncontrolled on less than 3 drugs. I think Medicare, their patients and providers would benefit through more effective blood pressure control. I appreciate your seeking input of providers.

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I practice cardiology and care for a good deal of hypertensive patients. I want Medicare to know that TEB has been instrumental in my practice's improved control of hypertension. Our experience and control rates mirror those of the published randomized controlled trials. TEB truly is a significant advancement in the treatment of hypertension. Our cardiovascular institute encourages Medicare to find a means of expanding coverage for use of TEB in more hypertensive patients. We would recommend your review and consideration of a nationalize policy that allows TEB coverage for hypertensive patients that do not respond to modifications in diet, exercise and initial antihypertensive therapy. Thank you,

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I am am an N.P. treating hypertensive patients in a cardiology practice and want you to know that ICG has made a tremendous difference in our control of hypertensive patients. We use the ICG data to objectively select specific antihypertensive classes of medications, titrate dosing of specific classes and to educate patients on why we are choosing certain meds and show them the results of taking the medications. Our practice hopes you can find a means of expanding coverage and ensuring that all local Medicare contractors provide for coverage. Unfortunately our non-comorbid Medicare patients are not covered and can not benefit in the manner our private insurance and other government (e.g. postal and state employees) can. We encourage you to visit practices that use ICG on a regular basis so you can witness the benefits of ICG.

Thank you, M. Inga McDonald, NP

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I would encourage CMS to allow ICG to be used in hypertensive patients not responding to our initial attempts with diet, exercise and other lifestyle modifications as well as one to two antihypertensive medications. After these attempts, I believe it would be prudent for Medicare to allow ICG utilization for the improved selection of medications which has proven to lead to improved blood pressure control. Please contact my office at 414 321- 4343 should you have questions regarding the value of ICG for the better treatment of hypertensive patients. This will save money in the short term for office visit and drugs and in the longer term for prevention of advancement of more expensive cardiovascular diseases. Thank you, Steve Chang, M.D. Internist Limited Ltd.

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I have a busy internal medicine practice and find ICG to be extremely useful in selecting meds for efficient control of my high blood pressure patients. I find the ICG data useful for really all of my hypertensive patients, from those not responding to initial therapeutic intervention to those that have been resistant for many years. In general, ICG has allowed me to control my patients, regardless of the amount of time they have been uncontrolled, in 6 or less months, if I utilize on a 3 week to 5 weeks (on average monthly) basis. I believe that ICG can truly save Medicare money if the coverage divisions would allow it to be more broadly used on a wider range of patients, but not abused. Part of the problem is also due to the fact that not all local Medicare contracted companies allow the use of ICG for hypertension. Please change the policy to a national type of coverage as well as allowing usage on less resistant patients. Thank you for considering these recommendations.

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ICG use has helped me use antihypertensive medications more intelligently by knowing more about the patient's fluid status, cardiac workload and systemic vascular resistance. I can make better choice on BP meds. It would help to use it earlier, on patients I may not see but once or twice yearly. Unfortunately I am not able to aggressively treat and control these patient's hypertension because of infrequent office visits and ICG could help control BP earlier and potentially prevent later complications. Thank you for your consideration.

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Dear CMS, I thoroughly read your decision memo for ICG for hypertension coverage and can not agree with your evidence analysis and Decision Summary to not expand coverage and to leave this to Medicare contractors' "reasonable and necessary determination". To begin with, Medicare contractors are incentivized not to cover reasonable or any discretionary services. We are dealing with a technology that has proven benefit in peer-reviewed randomized controlled trials, your highest ranking for methodological principles of study design, for lowering blood pressure better than standard means. ICG is low risk, low cost and justifiable for use in hypertensive patients not responding to initial therapy. I hope you can reconsider you initial decision memo and understand that your initial decision memo does not represent your stated methods for analyses.

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Dear CMS:

I am an internist treating a wide variety of patients of which a significant percentage are Medicare beneficiaries.

I am saddened by the draft decision on TEB announced on August 24. Medicare has vacillated from coverage of this diagnostic test that was too broad and resulted in Medicare being concerned with over-utilization to narrowed discretionary local coverage that has degenerated into essential non-coverage without any new clinical evidence.

Given the incredible drug (Part D) and physician (Part B) expenditures to control hypertension and the abysmal national control rates, I would hope Medicare could find in the new positive data from the CONTROL trial sufficient evidence to craft a new NCD somewhere between the ineffective and inappropriate extremes of the last seven years. Please note my displeasure with the inconsistent coverage and apparent lack of understanding from Medicare of the importance of this inexpensive but valuable test. I request that you consider coverage for patients that are >140/90 (and less for co-morbid conditions) that have failed initial antihypertensive treatment.

Edwin Alexander, M.D.

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Medicare Coverage Group for ICG,

This letter is from a group practice of internal medicine physicians with a practice of approximately 6,000 patients many of whom we currently treat for hypertension. Not nearly enough of them were at goal BP of 140/90 prior to using ICG.

Many of our patients are Medicare beneficiaries and I follow closely the coverage decisions made by your program. I am confused and confounded by the draft decision on ICG for improved blood pressure control. Uncontrolled abp for diagnosed hypertensives on drugs is a national scandal in terms of public health risks and unjustified drug costs paid for and by Medicare and private insurers. Why does the agency refuse to consider the clinical trials, their evidence, and achievement of the studies' endpoints for ICG?

Why does CMS substitute its judgment for the academic/medical peer review that preceded publication of the trial manuscripts? Why does CMS require peer review publication of clinical trials and then reject their conclusion?

Why would CMS spend so much time, effort, and space in preparing a draft decision that focuses on suggestions for a NEW trial and so little on the results of the published CONTROL trial? Are readers to conclude that each suggestion is an implicit criticism of the Mayo and CONTROL trials? Are we to conclude that each iteration of an improved trial strengthens CMS' draft decision and establishes the worthlessness of Mayo and CONTROL?

I always assumed that CMS used science and objective consideration of data to reach its coverage decisions. Any dispassionate observer with the time to review the complete record and the intelligence to understand it must conclude that CMS has lost its objectivity on this technology. I am especially concerned about the use of portions of Dr. Flack's editorial to support the CMS decision. His remarks do not seem to be in the context I read and may be distorted into support for a position he was attempting to refute. Please use this comment period and the next sixty days to modify your initial decision to accurately reflect the data and physician comments. Thank you.

Regards

Melinda Allen , DO

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I was quite certain that CMS would consider the new TEB CONTROL study data and expand coverage for hypertension for less resistant hypertension or at a minimum, ensure access to all beneficiaries through a National Coverage Decision. I do not understand your decision. You note all the reasons you should not cover, many of which are not valid, and ignore the basic fact that in randomized controlled trials TEB produced lower target blood pressures as compared to our evidence based guidelines, which have failed considerably at providing acceptable control rates. CMS has an opportunity to provide improved care at reduced overall costs (savings on drugs and office visits) and should reconsider expanding the policy to one that mandates medicare contractors to allow use on patients who have not been controlled with lifestyle modifications and two drugs. Please note I have been in practice for 15 years and have treated a wide variety of medical conditions during this time, including hypertension, and TEB has provided much improved blood pressure control for my patients.

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ICG helps remarkably in evaluation of hemodynamic status and blood pressure control of hypertensive patients and this clearly leads to decrease in mortality, morbidity and cost of healthcare. This is evidenced in my clinic and the published studies. I think it would be ideal for Medicare to expand its ICG hypertension coverage to LESS than resistant hypertensive patients not responding to 3 or more drugs including a diuretic. Please drop the diuretic requirement, let the clinicians decide what is best for the patient and allow coverage to those patients not responding to 2 drugs. It will be better for Medicare and all patients.

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CMS authorities

I am a practicing cardiologist with 16 years experience treating hypertension. My treatment of hypertension has dramatically improved over the past two years since I started using TEB to select and dose the medications for my patients. I am writing about the recent CMS decision on TEB for improved BP control. TEB is an inexpensive diagnostic test that measures the two major homodynamic components of blood pressure and causes of hypertension: Cardiac Index and Systemic Vascular Resistance.

Despite the widespread use of drugs to control BP over the last 20 years and the annual expenditure of billions of dollars for office visits and drug prescriptions (now paid for by Part D Medicare), more than 30% of diagnosed and treated hypertensives do not have their BP controlled.

National measures of HTN in the Healthy People 2010 campaign document the failure of American healthcare to control blood pressure and the failure to achieve goals for more than two decades. I practice in New Jersey and for the last five-plus years Medicare has allowed the local Medicare carrier, Empire, to refuse to cover this important $40 diagnostic test that in successively random clinical trials has shown to improve the control of high BP.

For whatever reason, Medicare continues to ignore evidence about the value of this test and keeps demanding higher and higher evidentiary standards. At the same time, the agency has allowed the medical directors of its carriers to pass non-coverage decisions of TEB without ANY new clinical evidence that does not support coverage.

In the face of overwhelming positive evidence, does it make sense for Medicare to substitute its judgment for that of practicing physicians and peer reviewed and published clinical trials? In the name of objectivity and public health, I request the agency retract and reconsider its draft decision to have a national policy that allows for coverage of hypertension patients not responding to the usual diet, exercise and monotherapy.

Sincerely yours,

Errol Williams, MD, FACC

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I was discouraged to read your proposed decision memo suggesting that Medicare would have no change to the current policy for hypertension coverage for electrical bioimpedance. Your proposed policy is not appropriate based on the published clinical data on electrical bioimpedance and the everyday experiences of your providing physicians. The published clinical data clearly shows that electrical bioimpedance produces better blood pressure outcomes (as high as 104% better in the bioimpedance arm as compared to the standard treatment) through directing medication selection and dosing on previously uncontrolled patients on one to three medications.

Your review indicated that you do not have a clear understanding of how electrical bioimpedance assists in therapy selection. I suggest you conduct site visits at clinical practices to observe the use of this machine if you can not interact with the hypertension experts who have conducted the studies to better clarify your questions and/or trust the peer review rigorous process that published studies undergo prior to publication in the journals. I would also add that these studies certainly apply to the Medicare population even to the point of sub analysis on older patients. I would recommend a judicious policy to include treatment of patients who have not reached goal blood pressure after four months of appropriate hypertension management.

Thank you for understanding that your providers just want a fair policy that will allow us to use this technology to the benefit of appropriate Medicare patients.

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CMS' decision not to expand ICG hypertension coverage is surprising and not supported by the two randomized controlled trials, additional clinical evidence and reports from hundred of physicians that have treated hypertension for numerous years and now with ICG have experienced superior blood pressure reduction as opposed to our older methods of random selection of antihypertensive drugs. I believe there is more than enough sufficient evidence to support an expanded policy. You request new evidence but it seems that you have missed much of the evidence that was submitted. Reduction of blood pressure has proven to improve health outcomes, regardless of the mechanism, and this technology has two randomized controlled trial showing statistically significant differences in blood pressure control between the ICG and standard care groups. Guidelines do not segment patient treatment by age and the CONTROL trial also reported a sub-analysis on older patients demonstrating no difference in blood pressure reductions. Should be enough for generalizability requirement. Pharma trials short term blood pressure reductions have been maintained in the long run and the three month study duration criticism is not reason limit coverage. Your suggestions for a study design are excessive and unnecessary. I recommend a responsible response to this evidence is a national policy allowing use on patients uncontrolled on 2 or more medications.

In good health,Danka K. Michaels, MD

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I am cardiologist and want you to know that I am not in agreement with Medicare's proposed hypertension coverage for Bio Z ICG. Your current carrier discretion policy does not ensure that all areas of the country are covered for use and the state of New York is an example. Additionally, your policy is too restrictive and does not represent the data that has been peer-reviewed by hypertension experts and and published in leading hypertension journals.

Our practice requests that you have a national policy that ensures all carriers cover for a reasonable level of use of ICG for hypertensive patients. It is known that hypertension is a serious problem for our country and left uncontrolled these patients inevitably develop LVH, ischemic heart disease, strokes and CHF. It would be prudent to allow ICG use on hypertensive patients that do not respond to initial pharmacologic attempts to control hypertension.

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To Whom it May Concern: I have treated hypertension for 25 years in a family practice setting and have added ICG to my clinical practice in the past two years. I have been able to duplicate similar outcomes as those described in the 11 site ICG hypertension study from Wake Forest as well as the outcomes from the Mayo Clinic trial. Needless to say, the control of my hypertensive patients has considerably improved using ICG. I can also say that I get the results in a similar 2-3 months of treatment vs. my previous experience without ICG of taking anywhere from 9 months to many years of medication trial and failure. The results are also ongoing, and I know this was a question in Medicare's analysis of whether the 3 month trial period was long enough to determine if ICG was effective. I think most clinicians would confirm that it is.

Our practice would request a national policy that does not require submission of records for a $44 test. The automatic rejection of submission and request for records is routine and frankly an unjustifiable hassle for such an inexpensive test. You could do a moderate policy which still expands the coverage but requests that physicians over a few months attempt modifications of exercise, diet and treatment of up to 2 drugs prior to trying ICG. This is what I do in my practice and it helps determine which patients will benefit the most. I hope this will be helpful in formulating your final policy.

Winston S. Williams, Jr., M.D.
Siskiyou Medical Center

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CMS Coverage Team
In my 41 years of treating hypertension, I have not been so encouraged by the effectiveness of ANY approach, including the multitude of National guidelines, as I have been with the individualized approach based on homodynamic data that ICG offers. I am dumbfounded by your decision not to expand coverage for nonresistant hypertensive patients and absolutely do not support your decision. Outcomes are outcomes and the randomized trials clearly show improved outcomes through lower blood pressure regardless of mechanisms. It is well accepted that lowering blood pressure leads to reduction of the development of more advanced forms of cardiovascular disease including ischemic myocardial infarctions, strokes and heart failure. Additionally, ICG has proven mechanisms but that is not the point and should not be an issue for Medicare.

Furthermore, you clearly state your decision section on "Assessing Individual Studies" that methodologic attributes associated with stronger evidence include...:Use of randomization...use of contemporaneous control groups...and prospective studies ensure a more thorough and systematical assessment of factors related to outcomes...". It further states that randomized controlled trials are the best at minimizing systematic bias. Both the Mayo and CONTROL studies that were evidence for expanding ICG coverage encompassed all of these components.

It is contradictory that Medicare would be so resistant to a low cost, low risk, high benefit solution for a problem that is of significant magnitude for Medicare beneficiaries and the population at large. Please reconsider your analysis and logic on this issue. Let objectivity prevail and recommend a middle of the road policy that would reflect recent clinical data, such as a policy requiring all carriers to cover for hypertensive patients unresponsive to lifestyle and therapeutic interventions of two antihypertensive medications.

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Re CPT 93701 Electrical Bioimpedance/ICG for hypertension
Your proposed decision to continue to let contractors determine use of ICG for resistant hypertension is not justified and basically says that Medicare is not interested in providing uniform and improved coverage for treatment of a disease that you admit has 70% of treated patients uncontrolled. These national stats are after great lengths of treatment. ICG has proven in clinical practice and high quality randomized research studies to outperform our standard methods of treating hypertension in a much shorter period of time. Two randomized controlled studies with excellent results should be enough to justify coverage. At a minimum I recommend a uniform policy that allows treatment on patients not responding to two or three medications.

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CMS Re Proposed Decision Memo for Electrical Bioimpedance (CAG-00001R2) I was dismayed in your Proposed Decision Memo for Electrical Bioimpedance for hypertension coverage. Many of my colleagues would agree that ICG has revolutionaries our treatment of hypertension of which I have treated for 25 years. In reviewing your Decision Memo, under section VII. Evidence, B. Discussion of evidence reviewed, you discuss the editorial by JM Flack which accompanied the CONTROL publication in the journal, Hypertension. I was quite surprised by the difference in my read/interpreted meaning of the editorial and CMS' interpretation of the editorial. You seems focused on emphasizing the questions that underscored your position on coverage verses the overall content of the editorial. I would like to remind all commenters and individuals involved in this process to consider the last (summarizing) paragraph which concludes Dr. Flack's editorial:

"...It is encouraging to see a new, valid technology available in the practitioner's office that can be used to improve the likelihood of successful BP control by improving therapeutic decision making. This, I believe, will be one of several advances in the coming years that will truly usher in the era of individualized hypertension management."

I hope CMS will realize the importance of this low cost/risk technology that has conclusively proven in two randomized control trials to improve outcomes through reduced blood pressure levels. Given this evidence, I would recommend a coverage policy that ensure coverage for all Medicare hypertensive beneficiaries that can not be controlled on initial attempts of pharmacologic therapy.

Raymond Itagaki, M.D.

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Decreases in blood pressure are validated to improve outcomes and ICG has overwhelmingly helped me to do so for my patients in the last four years. I find it difficult to believe that Medicare will not account for the increasing amount of positive clinical evidence that has been published supporting ICG use in controlling hypertension better than our guidelines that have proven highly ineffective. Certainly with the CONTROL trial outperforming the MAYO clinic trial and broadening evidence, you would find a means of enhancing Medicare coverage to address the less resistant hypertensive population to ensure a faster and more effective rates of control. This will save Medicare money on office visits, drug costs and longer term complications.

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To Medicare Coverage re ICG hypertension policy
Please reconsider your position on not expanding ICG hypertension coverage. I have found ICG to be extremely helpful in selecting antihypertensive meds in a similar manner to the published randomized trials. ICG objectifies the med selection by providing parameters that make up blood pressure. We have comparable control outcomes in all ranges of patients and actually find it even more helpful in older patients who have multiple symptoms including shortness of breath and fatigue when taking antihypertensive meds. Although the recent randomized trial demonstrated improved blood pressure in patients on one, two and three meds, a workable policy would be to have a uniform national coverage for patients not responding to tolerable doses of up to two antihypertensive medications. Since all patients can not tolerate diuretics, you may consider removing that language. Thank you,

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CMS Coverage Staff

I have utilized ICG for 5 of the last 30 years that I have treated hypertension in a busy internal medicine practice which involves management and care of hypertension among a practice that includes many Medicare beneficiaries. I am astounded at the August 28, 2006 draft decision to continue the NCD of essential non-coverage for ICG.

No other diagnostic test currently covered by a Medicare NCD has been require to meet the evidentiary standard that ICG has met. Still, Medicare has decreed that the evidence from the CONTROL trial is insufficient to obtain coverage.

For 3 years, Medicare has allowed local carriers to pass LCDs of non-coverage without the consideration of ANY new evidence. Given the cost of hypertension to the US healthcare delivery system and the low rate of controlled BP among Medicare beneficiaries, the agency's past actions and proposed decision are impossible to comprehend. Frankly my local carrier initially took the hypertension ICD-9 codes away, then re-added and has subsequently removed them in the past year only as evidence has grown stronger.

I urge you to revisit the draft decision, consider the recommendations of PRACTICING physicians who treat HTN every single day, remove discretionary coverage from local carriers, and broaden coverage for uncontrolled hypertensives after evidence of failure to control.

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CMS: Since using ICG to guide my therapy, I have been able to achieve better BP control in my patients. Previously, it was similar to shooting in the dark without the additional ICG parameters to guide therapy. CMS proposed policy is not representative of the RCTs nor that of hundreds of physicians logging comments. I recommend your policy endure uniform coverage for all patients by providing a national coverage policy for patients not responding to initial attempt with 1-2 drugs and usual lifestyle changes. Gordon Wang MD

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Medicare's proposed policy for hypertension for ICG does not reflect the randomized clinical trials which demonstrate that drug selection and dosing based on hemodynamics provides better Bp control than our standard guessing. I am strongly opposed to your proposal not to expand coverage to less resistant hypertensive patients as well as our carrier discretion status. This needs a national coverage for at least patients not controlled on two drugs. I have been treating hypertension for over 30 years in an internal medicine practice and have utilized ICG for the past 3 yeas. ICG is extremely valuable in controlling BP and hypertension management without this tool is suboptimal. Richard Blum, M.D.

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I have been treating hypertension since I graduated from medical school in 1985. However since I acquired the ICG machine my treatment of this disorder has changed radically. I am better able to choose medications now based on hemodynamics of the individual patient. The machine has allowed me to provide better quality care to my patients and I now find it indispensable. Unfortunately my Medicare patients are not covered because Trailblazers (local carriers) will not allow the use in hypertensive patients.

The published studies show that hemodynamics help in selection of drugs, i.e. greater use of ACE/ARB when SVRI is high and less use of beta blockers with cardiac index is normal or low and blood pressure was improved by at least 35% in the ICG arm (77% control rate vs 57% in the standard treatment arm). These randomized controlled results, coupled with thousands of physicians attesting to the value of ICG in the treatment of this disease, should definitely direct Medicare to expanding the range of hypertensive patients that can be covered by its policy and ensuring a nationalized policy. I do not understand how you can recommend not expanding coverage. I do not support your recommendations.

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Our group do not concur with your impedance cardiography proposed policy to leave hypertension coverage at carrier discretion and three drugs. It needs to be allowed on patients not responding to at least 2 drugs. the data shows value on unresponsive patients on 1 or more drugs. This apparatus has brought us valuable information for the treatment of hypertension and hydration status and has been well received by our patients and our cardiology colleagues. My group has now been able to maximize medications based on these results and the trends that we see.

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Re: comments to medicare regarding Bioz

To Whom It May Concern: The goal in treating hypertension is to prevent LVH/cardiac enlargement. I know of no other device that tells you about the cause of LVH i.e.: elevated SVR, SVRI, Regardless of level of BP, reducing SVR/SVRI with ACE/ARB, CCB occurs very rapidly with the use of Bioz and hence decrease LVH occurrence. I only bill medicare for hypertensive patients that I treat with Bioz (vs. the aforementioned patients) but can tell you I have several patients with BP's of 113/60 who have highly elevated SVR/SVRI with marked decrease in cardiac/stroke indexes who would not have been treated without the Bioz being available. My personal belief is elevated BP is meaningless in the treatment of hypertension, it is only a sign of the disease but some patients with "normal" BP are in trouble. I have had Echo's on patients with BP's of 113/60, untreated and show LVH!! Please consider my comments on this matter and understand that you need to allow for more hypertensives to be treated than you currently do. The Bioz will prove to be an indispensable tool and right now with your current policy you are missing the value of Bioz.

Sincerely, Michael Mattice, M.D.

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Re Proposed Coverage Decision for ICG: Short-term gains in BP have been shown to be maintained in large pharmaceutical trials and is not a valid criticism of the CONTROL trial. The ICG arm was able to obtain a 77% BP control rate on previously uncontrolled hypertensives in only three months which is less time than it usually takes to achieve such a high control rate. The Mayo Clinical trial already shown ICG's benefit on a largely co-morbid population. Furthermore the CONTROL trial manuscript also discussed that a sub-group analysis demonstrated ICG to maintain superiority in older patients so generalizability is not a valid criticism. CMS should understand that ICG is an important advancement in the treatment of hypertension and should allow some form of expanded coverage beyond that of the Mayo Clinic Trial. A national coverage policy for patients unresponsive to diet, exercise and initial therapy is reasonable and prudent

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The bioz equipment provides information unique for the diagnosis, treatment and follow up of arterial hypertension. The objective measurement of blood pressure through peripheral vascular resistance as well as the measurement of cardiac function is essential for the evaluation of current therapy and provides evidence beyond usual brachial blood pressure to determine if therapy is adequate or not. Prognosis is expected to improve with the routine use of this technology. I recommend your final policy reflects the clinical published data which show the bioz technology useful on uncontrolled hypertensive patients on fewer drugs than your current policy of 3 drugs.

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CMS-Re ICG for hypertension

With ICG, I find it easier to identify what medications or class of medications I would use to treat my hypertensive patients. In fact my patients feel better when proper medication is used, especially if we can reduce the amount of medications used. I would say that I have had approximately 90%improvement in patient care in regards to HTN with the help of ICG. Patient medication compliance is better also because of less side effects with appropriate medications and we use ICG report to help the patient see why they need a medication and the subsequent effects on the medications on the parameters on the report.

Why would CMS not want to look at the publications in the hypertension journal and appropriately expand the CMS policy to a national one to include essential and benign hypertensive patients that have remained hypertensive in spite of treating on 1-2 medications?

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ICG measures systemic vascular resistance in a non-invasive way. If a hypertensive patient is already treated on 1-2 antihypertensive medications, still has slightly elevated/borderline blood pressure and has a high SVR on ICG, it would behoove the physician to increase/add antihypertensive therapy directed at SVR, for example an ACEI or ARB, instead of adding/increasing beta blocker. The SVR can be followed and look for improvement.

Please reconsider the published trial work for ICG and consider an expanded policy based on treating physicians' experience and publications of randomized trials.

Jack Kleid, MD, FACC, FACP

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I am an endocrinologist who has treated hypertension for over 15 years. I have used the electrical bioimpedance machine for almost 3 years and have found it to be great assistance in aiding to diagnose and treat my patients. Current reimbursement policy limits ability to fully use and benefit patients.

Controlling hypertension more quickly is cost-effective in the short and long term and benefit patients, physicians and Medicare. Medicare should make the reimbursement policy for hypertension more practical to include patients not responding to less than 3 drugs (I.e. 2), remove diuretics clause as not tolerated by all patients or indicated for hypertensive dialysis patients and make it standardized policy for all U.S. physicians. There is published data to support all these recommendations.

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Medicare needs to review the published randomized studies using ICG for the treatment of hypertension and have its national policy in accordance. These studies are of high quality, involve as many as 11 sites and demonstrate quite impressive control rates as compared to our standard treatments. The subgroup analysis certainly show that ICG maintain better control in older populations and if Medicare could get all hypertensive patients under control in three months they would save allot of money on physician office visits and drugs. A three month study demonstrating 77% control should not be questions and pharmaceutical trials have shown that shorter term gains in BP are maintained over longer terms.

In my clinical practice, using ICG has made making choices of antihypertensive appropriately easier. It has given me another tool to help determine how to adjust BP meds without making patients feel poorly, reduce cardiac output unnecessarily or use entire class of drugs that would not be helpful for a particular patient. I have been able to adjust BP more quickly and get it to goal faster with the use of ICG. I also use far fewer prescriptions, class of medications and dose changes than I did before. The published studies showed this also when they reported fewer does increases and decreases. A reasonable policy would be for patients not responding to initial recommendations of exercise, diet and monotherapy. Thank you for consideration of my comment.

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I am a family practicioner and specialize in geriatrics. BioZ has helped me decide the appropriate medicines for high blood pressure and has helped me keep people of of the hospital. Medicare, patients and providers could all benefit if Medicare would have a coverage policy providing for treatment of hypertensive patients uncontrolled by initial attempts. You proposed policy needs to be revised. The publications report that BP control could be improved by as much as 35% over a three month period.

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ICG is an outstanding and invaluable tool to aid in my management of poorly uncontrolled hypertension. Sadly, I can not use on my Medicare patients as our LMRP does not allow for coverage for hypertension. This does not make sense. I would think changing to a policy that allows uniformity in coverage for all patients not responsive to first line attempts at controlling hypertension. The published manuscripts show that ICG has an objective mechanism for selection of medication with improved outcomes. What more do you need?

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To Whom It May Concern: Medicare's draft decision and rationale for "no change in coverage" due to "insufficient evidence" has no basis and I strongly oppose this draft decision. I request that your coverage and analysis group be questioned as to its objectivity in analyzing the data. Many questions in the proposed coverage decision were addressed in the published manuscript, including how ICG caused a difference in the medication class and dosing. The use of SVRI was evident-when it was high there was a greater use of ACE/ARB/CCB; when CI was normal or low, there was a decreased use of beta blockers.

Furthermore, the study results are indeed reflective of the Medicare population: our national JNC guidelines do not alter with age and there was also a reported subgroup analysis showing the ICG arm maintained better BP control in older patient population.

This is a relatively inexpensive test that has helped numerous physicians and patients better control BP when our initial attempts have not worked. I suggest your policy be revised to correspond with the published data and reported comments of your providers.

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Regarding Medicare's Proposed TEB Coverage for Hypertension:

I am a board certified cardiologist with extensive experience treating thousands of hypertensive patients. I am writing about the agency's recent draft decision on TEB that there is insufficient evidence to support a request for broadened hypertension coverage. While this draft decision may be reasonable given the broad and expansive requested reconsideration language, it ignores a large range of other possible coverage decisions that CMS is empowered to make and that would contribute to improve health outcomes for Medicare beneficiaries.

Given the actions of local carriers to move to non-coverage of TEB without ANY new adverse clinical evidence, including in the state of Maryland which was one of the initial carriers not to why even before the first reconsideration, does Medicare propose to leave its current coverage unaltered? Did the agency not read the RESULTS of the 11 center recently published randomized, blinded, double arm study? CMS appears to have focused on the process of the study, i.e., its design and methodology, rather than its results. It should be noted that many of the questions about the process are answered in the study description in the manuscript.

Given CMS' emphasis on results and health outcomes, why has it ignored the results and outcomes of this trial which show clear improvement in the TEB arms? It appears that CMS is a priori opposed to the TEB diagnostic test and uses its draft decision to create numerous straw men and then proceed to destroy them without a consideration of the trial's results.

I urge you to return to the review process and fashion a different and more reasonable NCD that improves upon the current coverage policy without going all of the way to the literal language of the submitted request. Certainly a middle ground would be patients not a target BP on 2 or more antihypertensive drugs.

Thank you.

Sincerely, Hasson Kassamali, MD

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CMS, I want to comment that our practice does not agree with your decision for no change in coverage for electrical bioimpedance. Our practice and the studies show evidence that electrical bioimpedance helped BP control much more than our standard guidelines, in a shorter period of time and are reflective of the older Medicare populations. Electrical bioimpedance has more evidence for help in BP control than many of our other tests and does not cost our healthcare system much money. Far less than these patients remaining uncontrolled and developing strokes and heart failure. Your decision is not logical nor based on the evidence.

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I have treated hypertension for 32 years and have found the impedance device to be the most helpful tool in aiding my patients' control. I do not agree with your proposed decision for no change in your current policy and think the evidence is more than sufficient. Are not two randomized controlled clinical trials demonstrating at least 35% improved blood pressure control in the impedance arm enough to justify a national coverage policy allowing for treatment of hypertensive patients not responding to one or two drugs enough? It should be.

Recent Medicare decisions for cardiac technologies (ambulatory blood pressure and t-wave alt) did not have this quality of evidence. Impedance is an objective means of treating hypertension and has been shown in a wide range of patients to be better than standard treatment (resistant, those on less meds, older, co-morbid, etc). I highly recommend you change your policy to reflect the evidence and have national coverage for patients not at goal BP of 140/90 on two antihypertensive medications.

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Medicare Coverage,

I am an internist with 20 years experience treating hypertension. I am disappointed at Medicare's announced draft decision on TEB coverage for hypertension. It continues a recent history of dramatically narrowed coverage for an inexpensive diagnostic test that helps me improve the care management and health outcomes of my patients.

Medicare must know the American record of controlling hypertension. It is a dismal statistical, financial, and pharmacological failure. Why would Medicare ignore evidence about the usefulness of diagnostic information that improves the accuracy and timeliness of physician prescribing patterns and improved BP control? Why would Medicare not want to pay for this $40 test after the results of two blinded randomized clinical trials achieved their endpoints of improved hypertension control to < 140/90 mmHg?

Why would it substitute the judgment of Medicare's non-practicing physician staff for the support and recommendations of clinicians and beneficiaries who have benefited from the use of this test as well as two blinded randomized clinical trials beating out standard treatment for hypertension? Please consider the publications that have undergone rigorous peer review by National hypertension specialists as well as the experience of hundreds of physicians treating thousands of patients and have your policy support this experience with coverage for patients not controlled on two antihypertensive medications. I also believe that a national coverage policy is essential as it is a game to give carrier discretion a ticket to no coverage as the carriers are not incented to cover any technology.

Umar Farooq, M.D.

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The impedance cardiography has helped to control blood pressure in many different patient etiologies, especially those who have had pedal edema. Information that before we only could have guess at to help control blood pressure and also congestive heart failure edema in diastolic dysfunction has come from impedance cardiography. The device has helped numerous patients and should have a hypertension policy that helps resistant patients as well as those not as resistant. Thank you. D. Mease, M.D.

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I have treated folks with hypertension for MANY years. Since I have had ICG available in my rural (underserved) internal medicine/geriatric clinic, I can clearly show anyone who wants to see:

1. reduction in LVH and subsequent diastolic problems
2. reduction of hospital visits for hypertensive emergencies
3. reduction of progression to renal failure

Continued overall reduction of medicare reimbursement will result in closing my practice within one year

Frances M. Yuhas, M.D.
The Dallas, OR

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I can not support your proposed decision for Bioz hypertension coverage which would undermine the potential for Bioz to help patients, clinicians and our country in cost-effective measures. The use of Bioz can greatly reduce the number of office visits and number of failed medicines. The ability to identify increased vascular resistance and/or increased cardiac workload takes the guess work out of treating HTN. Furthermore, early detection of increased vascular resistance with proper treatment can and will decrease future CHF development. I recommend CMS consider the published studies and clinical practice of physicians. Scott Williams, D.O.

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I find the Bioz very useful in assessing and treating my hypertensive patients not responding to exercise, diet and initial therapy. I have treated hypertension for over 20 years and in the last 5 years of using Bioz, my ability to control patients has dramatically increased. I do not believe your currently proposed policy reflects the study data or the clinical usefulness evident in practicing physicians. Please reconsider your proposed policy to better reflect the study data and clinical testimony of practicing physicians, Pradeepta Chowdhury, M.D.

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Over the last six years I have utilized impedance technology in my office and have found it to be a valuable tool in initiating and titrating medications for my hypertensive patients who are not at BP goal. I would ask CMS to extend the indication to allow more patients to benefit. By expanding the coverage for hypertension to include patients who are compliant with 2 medications, and have tried lifestyle modifications but are still not controlled would be of great benefit to all concerned and actually be cost-effective. Thank you for reevaluating the clinical evidence and your analysis.

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I can not support your analysis and decision proposing no change to the current TEB policy. TEB is a low cost, efficient tool that has dramatically improved my ability to control BP. By not advocating a broader TEB policy, you are basically supporting physicians just use whatever drug the last drug rep came to promote. National hypertension guidelines have continued to be ineffective as evidenced by ongoing high uncontrolled BP rates and revisions every few years to the guidelines. If you would consider the published data, it would be a service to all you providers and beneficiaries. I ask you to be objective in your decision and provide some improvement to the current policy. A national policy is a must.

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Public Comment for Electrical Bioimpedance for Cardiac Output Monitoring

It is disillusioning to read your coverage analysis for Electrical Bioimpedance. I have used Electrical Bioimpedance for four of the 16 years I have been practicing and can validate its contribution in improving blood pressure control in patients with hypertension. A study from the Mayo Clinic showed a 70% improvement in BP control compared to therapy by a hypertension specialist who did not use Electrical Bioimpedance. The April 2006 study demonstrated that BP <130/85 was achieved with double the frequency in the Electrical Bioimpedance arm as compared to standard practice arm. There was also a 35% increase in BP control to > 140/90 in the Electrical Bioimpedance arm (77% vs 57%). With peer reviewed journal support that Electrical Bioimpedance data considerably improves hypertension management, I believe CMS needs to reconsider the national coverage for hypertension to include patients not responsive to a certain level of treatment, for example after three months treatment and uncontrolled on two medications. Additionally, the diuretic requirement is not practical for all patients. Finally, local carriers need direction with the appropriate ICD-9 codes to support the indications.

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After the continuing positive clinical data in hypertensive patients demonstrating ICG to be significantly more superior as compared to our standard care, I am very disappointed to read Medicare’s proposed coverage analysis. In addition to my medical degree and training, I also have a Masters in Public Health and have treated hypertension for over thirty years. We have not had an effective clinical tool to assist in our clinical assessment and care of hypertensive patients until the development of ICG. Over the past several years, ICG has allowed me to tailor my therapeutic approach and achieve blood pressure control more effectively than using guidelines and my clinical assessment alone.

The two randomized controlled clinical trials produced impressive results, with the Hypertension April 2006-published, 11-center study producing an eight mm Hg systolic and seven mm Hg diastolic greater blood pressure reduction as compared to our standard care. Your analysis seemed cursory with many of your questions, including those related to the medication differences resulting from availability of ICG parameters and randomization, addressed in the Hypertension April 2006 study manuscript. Your analysis also took an objective, yet supportive, editorial by Dr. John Flack and frankly, from my impression, misinterpreted the author's intent.

Hypertension is a public healthcare crisis, affecting approximately 27% of U.S. adults, and over the past few decades we have not made significant progress in improving control rates. We must do something different and be open to new technologies, such as ICG, which has proven in two randomized controlled trials to be superior to our national guidelines and standard care. In order to appreciate the importance of the eight mm Hg systolic and seven mm Hg diastolic greater blood pressure reduction in the ICG-arm of the aforementioned study, I refer you to a meta-analysis study published in 2002 in Lancet involving 61 prospective studies and one million adults. This study demonstrated that a 10 mm Hg lower systolic BP or five mm Hg lower diastolic BP was associated with a 40% reduction in stroke death and 30% reduction in ischemic heart disease or other vascular cause of death.

If we can control hypertension, we can significantly reduce the progressive, more costly advanced cardiovascular and renal diseases, myocardial infarctions, strokes, and congestive heart failure. For the sake of patients who suffer from hypertension and the treating physicians, I encourage you to take a more objective analysis of the provided data and to expand coverage of ICG to uncontrolled hypertensive Medicare patients not responding to a 2-drug regimen. Thank you for your consideration of my perspective and experience.

Jan J. Yuo, M.D., M.P.H.

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To Whom It May Concern at CMS,

I am a cardiologist who has treated patients with hypertensive disease for the past 20 years. I must say that I disagree with your recently posted proposed policy for electrical bioimpedance technology. Over the past five years, electrical bioimpedance technology has improved my care of hypertensive patients through providing objective and accurate hemodynamic parameters that improves the assessment and treatment decisions for selected patients. Unfortunately my Medicare patients have not been of benefit due to the national carrier discretion and subsequent local coverage policy which does not allow coverage.

I am surprised with your conclusion of “insufficient evidence” for more coverage. I am not sure that any other test in my office has 2 RCTs to support its use. Electrical bioimpedance can reduce healthcare costs and prevent unnecessary disease progression. I request reconsideration of the clinical evidence and current and proposed policy and make electrical bioimpedance more available to the patients not responding to initial therapeutic interventions.

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I am writing to oppose your proposed policy for electrical bioimpedance. I have practiced cardiology and treated hypertension for 35 years. ICG represents an opportunity to improve our National hypertension control rates but your proposed policy will not allow for that possibility. It confounds me why CMS would not embrace a cost-effective, randomized controlled trial-proven technology that can make a difference in healthcare. Your very short-term focus on minimizing tests that clinicians can use to the benefit of their patients is painfully evident through overly restrictive coverage policies. I respectfully request that you reconsider the value of electrical bioimpedance in the treatment of hypertension and allow a policy that would benefit patients not responding to two antihypertensive agents. A policy along these lines seems reasonable and fair given the clinical evidence.

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Re: CMS proposed coverage decision for ICG

I am a MD, PhD specializing in internal and preventive medicine. I am recording my disagreement regarding CMS proposed coverage decision related to hypertension coverage for ICG. I have found ICG to be a valuable tool in the treatment of hypertensive patients. Your current coverage policy and proposal to leave it un-expanded demonstrates an lack of appreciation for the valuable information and results that ICG provides in the treatment of hypertension. There are numerous clinical publications supporting the role of ICG in patients with hypertension in the areas of diagnostic, therapeutic and prognostic. As you note in your analysis, the most current 11 center generalist setting study showed 8mm Hg/7mm Hg improvement in BP control using ICG information. Based on the enrollment criteria of this trial, ICG demonstrated benefit for any patient in which initial therapy has not resulted in BP control. Restricting the coverage policy to a 3-drug regimen, carrier discretion is overly limiting in light of the results of this multicenter clinical trial and the prior results from the Mayo Clinic. I request that CMS reevaluate your own process and provide for a national coverage decision for hypertensive beneficiaries not responding to initial therapy including lifestyle modifications and therapeutic intervention with two drugs. Lastly, diuretics are not tolerated by/indicated for all patients and should not be part of a functional coverage decision.

Regards,

Joon Rhee, M.D., Ph.D.

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Centers for Medicare and Medicaid,

I was disappointed to learn of your preliminary decision not to expand TEB coverage for hypertension. There is plentiful testimony from practicing physicians as to the value of TEB in hypertension treatment as well as two RCTs. This should be sufficient clinical proof. Of additional concern is your policy of carrier discretion. Empire is our local FI and does not cover drug resistant hypertension. I would like to voice my concern with leaving this decision up to the discretion of FIs. I have reviewed several coverage policies issued by other CMS FIs. There is considerable variation in data interpretation as reflected in their policies and associated ICD-9 codes. The majority of FIs allowing coverage of drug resistant hypertension fail to include the ICD-9 code that describes the vast majority of underlying diagnoses: 401.1. The result has been inconsistent beneficiary coverage. Please reconsider the current coverage for hypertension application to at a minimum include National coverage so those Medicare beneficiaries in my state can benefit from TEB for uncontrolled hypertension. I also encourage you to consider the clinical data and reduce the number of drugs required.

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I would like to voice my concern for CMS proposal for bioimpedance coverage in hypertension. It is unreasonable that you would not give more consideration to the newly published, second randomized controlled clinical trial of and provide for expanded coverage. Revising the indication of drug resistant hypertension to include those patients with uncontrolled hypertension not responding to two medications is reasonable given the clinical evidence. I encourage Medicare to provide national standards on the hypertension indication to ensue this important test is more accessible to patients who truly can benefit from it.

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I am an internist in practice for 30 years. I have used the ICG for 2 yrs and found it helpful in many hypertensives. Many pts on beta blockers for risk reduction have clinically improved in exercise tolerance with decreased DOE after the ICG showed increased vascular resistance and suppressed cardiac indices and I stopped the beta blocker. I find that the machine helps me stratify my treatment choices. If the vasc resistance is high, I use more dihydropyridine CCBs and ACE inhibitors and ARBS. If the cardiac and vascular resistances are equal, I use a balanced drug such as cardizem. If the cardiac index is high, more beta blockers.

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CMS-Please consider I am a cardiologist who has treated hypertension for 20 years. I have found impedance cardiography very helpful in choosing blood pressure medications. As with the published trials, it has improved outcomes through more rapid control of blood pressure. Your initial decision does not reflect the recent published trial in the April Hypertension Journal and I encourage you to refer to the outcomes evidence of improved blood pressure control on less resistant hypertensive patients as you conclude your process.

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I am disappointed in your coverage proposal to not expand hypertension coverage for ICG. I am a cardiologist and have been utilizing ICG technology to help manage my patients with uncontrolled hypertension, congestive heart failure, and differential diagnosis of dyspnea. ICG has proven very helpful on difficult to control patients. Unfortunately due to our local policy, I do not get paid from Medicare for treatment of isolated hypertension. As a result, your policy causes my private pay patients to receive superior care than my Medicare patients. With ICG, I have been able to more objectively select medications and control my hypertensive patients. I strongly believe that ICG should be part of our treatment options for patients with uncontrolled hypertension. Please consider expanding the current NCD. It is overly restrictive and limits access to patients who would benefit from its use.

Sincerely,
Dr. Olkovsky

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To Whom It May Concern:

I am a board-certified cardiologist practicing in New York. I do not understand the rationale nor agree with your proposed coverage decision for electrical bioimpedance. Our contracted Medicare administrator, Empire, has chosen not to cover hypertension under your carrier discretion policy. Given the impressive randomized trial results of electrical bioimpedance as compared to standard treatment as well as the overwhelming number of positive physician comments, I would hope that Medicare would realize that this technology has a place in our era of cost-containment medicine. As you know, it is a relatively low cost test that can help us more effectively control blood pressure in less office visits and with less trial and error prescribing of antihypertensive medications. I understand in your proposed coverage that you have a number of questions about the trial results. Please trust the peer-review journal process, especially in journals such as Hypertension, which is an American Heart Association journal. This is the leading hypertension journal which employs hypertension specialists in its review process. Also know that articles are limited in the number of words allowed (therefore the content and analysis), as well as understanding that a number of your questions are addressed in the April 2006 Hypertension manuscript (R. Smith, et al.).

I would hope, at a minimum, you would want electrical bioimpedance to be employed in clinical care after clinicians’ initial treatment has failed. In order to ensure that electrical bioimpedance is available for appropriate clinical care, there needs to be a national coverage decision directing contracted Medicare administrators and providers to use electrical bioimpedance after initial therapeutic attempts, including lifestyle modifications, have failed. I encourage you to find a reasonable means of expanding coverage.

Charles Schwartz, M.D., F.A.C.C.

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As a cardiologist, I have found ICG instrumental in my practice. It is very helpful to have Hemodynamics (SVR, SVRI, CI, CO, Fluid Contents) to optimize anti-hypertensive Rx. You exactly know which medication to alter. Unfortunately, in NY, I can not use it for my hypertensive patients because of Medicare’s carrier discretion policy. I do not support carrier discretion restricting use to resistant hypertensive patients. You have an opportunity to provide a valuable, low cost test for a national problem. I support a national decision for less resistant patient population.

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CMS, Please note that I do not support your draft policy for ICG. I have used ICG for three of the eight years that I have treated hypertension. The use of ICG in treatment of HTN has had a huge impact on my practice. It has increased the number of patients who reach goal BP and decreases the amount of time it takes to get them there. It allows me to target problem areas and more effectively choose medications to treat these areas. By knowing which class or classes of medications will be more effective, I can often reduce the number of drugs needed. I will continue to use this valuable tool even if insurance fails to provide coverage because it is just good medicine. I encourage you to expand coverage beyond your draft policy to include at least patients not responding to 2 drugs.

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[copy of letter sent to CMS on April 18, 2006]

Louis Jacques, MD
Madeline Ulrich, MD, MS
Michael Lyman, RN, MPH
Coverage and Analysis Group
Centers for Medicare & Medicaid Systems
7500 Security Blvd.
Baltimore, Maryland 21244-1850

Dear Drs. Jacques and Ulrich and Mr. Lyman:

I was disappointed to read the letter to CMS from the American College of Cardiology (ACC), dated March 29, 2006 regarding the CMS reconsideration of thoracic electrical bioimpedance (TEB) for hypertension. As you know, I am a cardiologist, co-principal investigator for the CONTROL trial, and have extensive knowledge of the evidence supporting TEB coverage for hypertension. Because the comments from the ACC were posted several days after the public comment period ended and due to the nature of the comments, I request that my response be posted as well.

Due to the nature of the opinions expressed in the letter, I believe that it was unlikely that those who were asked to provide comments were able to spend the necessary time to fully understand the evidence and its implications. I therefore offer the following response to several opinions stated in the ACC letter: ACC Comment: “Our clinical experts noted that the two small randomized studies cited by the requester focused only on patients with blood pressure that was quite difficult to control.”

I respectfully submit that this statement is incorrect in both the description of the patients that have been evaluated and also in reference to the “small” size of the studies. Whereas the Mayo Clinic trial was designed to analyze treatment of resistant hypertensive patients on two or more medications (average 3.6) and were “quite difficult to control”, the CONTROL trial was purposefully designed to study non-resistant hypertensive patients who were uncontrolled on one, two, or three medications (average 1.6). A total of 147 of 164 patients (90%) in the CONTROL trial were on one or two medications at baseline, and 127 of 164 patients (77%) were taking one or two medications at the final visit.

Regarding the reference to “small” numbers in both studies, both the Mayo and CONTROL randomized trials were prospectively powered to achieve statistical confidence in differences between endpoints between arms. As such, neither study should be defined as “small” by looking at the number of subjects. In the case of CONTROL, the size of the study was chosen to detect a 5 mm Hg difference in change in BP from baseline to final between arms at an alpha of 5% and a beta of 20%. Other hypertension trials require more patients for one simple reason - there are smaller expected differences between arms. For example, if we had targeted only a 2 mm Hg difference (as many pharmaceutical agents have shown), we would have needed many more patients in the study. Our hypothesis was that TEB would result in a relatively large difference of 5 mm Hg between arms, which appropriately required a smaller sample size. It is simply inappropriate to label a study as “small” that has been powered appropriately and has achieved clinically and statistically significant results. As noted, the CONTROL trial results exceeded the expectations of the investigators. For the primary endpoints in the study, the 8 mm Hg greater drop in systolic blood pressure was achieved in the TEB arm with a p&< 0.01 and the 7 mm Hg greater drop in diastolic blood pressure was achieved in the TEB arm with a p&< 0.001. Therefore, there would have been no added benefit in enrolling more patients in the CONTROL trial. I encourage you to consult an expert statistician if you have further questions on this matter.

ACC Comment: “The patients were typically on multiple anti-hypertensive drugs and were, on average obese. These factors limit the extent to which the results of the studies can be generalized to the broader population of patients who have failed to achieve desired blood pressure control on only one or more antihypertensive drugs.” The patients enrolled in both trials represented a broad continuum of uncontrolled hypertensives and allow the results to be generalizable to the Medicare population:

MEDICATIONS* More baseline medications (two or more, average 3.6 for Mayo) and fewer baseline medications (one to three, average 1.7 for CONTROL);

BP LEVEL* Severely high baseline BP (Mayo) and mild to moderately elevated baseline BP (CONTROL)

AGE* Patients who were older (average age 65 in Mayo) and those who were slightly younger (average age 55 in CONTROL). The CONTROL subgroup analysis also evaluated age and concluded that age had no effect on achievement of study endpoints

COMORBIDITIES* Patients with significant comorbidities (Mayo) and those with fewer comorbidities (CONTROL)

ISOLATED SYSTOLIC HYPERTENSION* Patients without isolated systolic hypertension and those with isolated systolic hypertension (CONTROL subgroup analysis)

DIURETIC USAGE* Patients not on a diuretic and those on a diuretic (CONTROL subgroup analysis)

In fact, the only significant populations that have not been evaluated in clinical trials with TEB are newly diagnosed hypertensives or those who are diagnosed but not receiving antihypertensive medications yet. CMS coverage has not been requested for these patient populations.

The enrollment criteria for CONTROL included uncontrolled patients on one, two, or three antihypertensive medications. Therefore, it is surprising that the ACC letter suggests that it is not appropriate to generalize the results to patients on one or more medications. In fact, the study was specifically designed to evaluate patients on fewer medications. In CONTROL, a total of 72 (44%) patients were on one medication at baseline and 75 (46%) were on two medications at baseline. While not reported in our paper, the results of the trial were the same when we excluded patients who entered on more than two medications. When the results for the 147 (90%) patients who were on one or two medications at baseline were analyzed, the TEB arm had an 8 mm systolic blood pressure reduction advantage from baseline to final (18 vs. 10 mm Hg, p&< 0.01) and a 7 mm Hg diastolic blood pressure reduction advantage (12 vs. 5 mm Hg, p&< 0.001).

The letter further suggests that the average BMI of 30 in CONTROL patients somehow reduces the applicability of the study. When over 60% of the US population is either overweight or obese, an average BMI of 30 is actually representative of the broad population of hypertensives and the trend toward greater BMI in all cardiovascular patients. It is also reflective of recent pharmaceutical trials in hypertension. For example, the ALLHAT trial of over 30,000 participants had an average BMI of 30. In the recently published TROPHY trial, the average BMI was also 30.

ACC Comment: “The studies cited do provide some evidence of benefit for a more narrowly defined patient population. The ACC believes that Medicare coverage for patients with drug resistant hypertension, defined as failure to achieve goal blood pressure when adhering to full doses of an appropriate three drug regimen, including a diuretic may be appropriate. We note that the current NCD already provides local Medicare carriers with the explicit discretion to coverage TEB for this patient population.” The current CMS coverage allows carrier discretion for resistant hypertension and was based only on the Mayo Clinic trial. Unfortunately, it has also resulted in inconsistent coverage to Medicare beneficiaries. CMS now bases its coverage decisions on evidence-based medicine and the ability of a service to improve net health outcomes. While this is a difficult standard for any diagnostic test to achieve, TEB has done so. The evidence from two randomized trials now supports the coverage of TEB to improve BP control in patients on one or two medications as well as patients on three drugs or more. I recommend that CMS issue a national coverage determination for patients who are uncontrolled on one or more medications. This indication is supported by the evidence and would provide consistent coverage by all carriers for both providers and beneficiaries.

Sincerely,

Carlos M. Ferrario, MD, FACA, FACC
Professor and Director
Hypertension and Vascular Disease Center
Wake Forest University Hospital
Medical Center Blvd.
Winston-Salem, NC 27157-1032336
716-0757 336
716-6644 (fax)
cferrari@wfubmc.edu

cc:Rebecca Kelly, Director, Regulatory Affairs, ACC
Steven Nissen, MD, FACC, President, ACC
Rhonda Rhyne, President, CardioDynamics

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I am disheartened by the new ruling. The Bio-Z is unbelievable. I have been able to significantly improve control in my blood pressure patients. It is a known fact that only 30% of blood patients are adequately controlled. The best part of the data able to be generated by the Bio-Z is the fact that patients can actually see what's going on in their body. The adage "blood pressure is a silent killer," does not exist in my practice. Patients are actually able to see what happens when we change or add a medication to control the BP more effectively. Patients are more motivated to taking their medication as prescribed and look forward to seeing how that medication has worked. CMS should make this test readily available for all hypertensive patients, if not require it. I invested in this machine not only to help add a significant measure of quality to my patient's care, but also to generate some revenue for my solo practice. I am barely keeping my practice afloat with decreasing reimbursements. How can I keep up with the cost of providing care my patients, your bebficiaries. One of my patients could be one of your loved one. Please reconsider your decision and do not take away the invaluable test. In fact, please make it easier to use and conder easing the restrictions. Your final decision will have an impact on access to excellent quality medical care that I am able provide, but now can't afford to provide it.
Sincerely and professionally,
Dr. Scott A. Kotzin
Mason, Ohio

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Initially I was very pleased to see CMS open coverage discussion for Cardiac Output Monitoring by Thoracic Electrical Bioimpedance; conversely, I was very surprised when you did not expand coverage. I have been using this technology over the past two years and found it to be of great benefit in my decision making process for many of my patients including those patients with resistant hypertension. Due to the restrictive coverage guidelines, a large number of my patients who are CMS beneficiaries, who suffer from uncontrolled hypertension, do not have access to this service. It is sad that I can control my more resistant hypertensive patients in less time after I do this test than my patients who are not as complicated but those which do not qualify for the test and therefore I do not have access to the data to make more objective drug selection and dosing.

The clinical data from the Wake Forest study showed considerable reduction in systolic (8mm) and diastolic (7m) pressure which translates to over 40% reduction in stroke and other CV morbidities and mortality. I strongly disagree with your draft decision and urge you to take a closer look at the clinical data and experiences of physician provider and find some amount of expansion, even if it is to only 2 drugs. Should you have any questions or would like to know more information, please feel free to contact my office.

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To Whom It May Concern,

I am writing about your recent draft decision on ICG for treatment of hypertension. I have found ICG to be effective in lowering blood pressure in my patients with uncontrolled hypertension and feel this technology should be available to patients who suffers from this condition and have not been controlled on lifestyle modification and initial therapy. In my 21 years as a practicing internist, I have found this tool to be one of the most valuable in improving my clinical assessment and assisting in patient compliance. Unfortunately, Cahaba, my Medicare carrier, only has ICD-9 codes for malignant hypertension, which is not always applicable, and they have not been willing to change the codes to include other types of hypertension that could apply to 3 drugs, I.e. essential HTN. The coverage of drug resistant hypertension limited to those uncontrolled on three-plus medications is overly restrictive and does not appear to be supported by the results of ICG hypertension study which was published in Hypertension, in April 2006, which demonstrated improvement in high blood pressure control with ICG selected therapy for patients not controlled on 1, 2 or 3 drugs.

Hypertension affects millions Americans and as you note in your document, our control rates are very low. I am surprised that with Part D that there is not more of a push to use ICG prior to CMS paying for hypertension drugs. This would be an effective means of saving money on unnecessary office visits and unused prescriptions due to mis-prescribing. I encourage Medicare to revise this indication by making it for national coverage and allowing coverage to any patient with uncontrolled hypertension that has not responded to initial therapy. A national coverage policy is essential to ensure uniform beneficiary access. I would also recommend a list of functional ICD-9 codes.

Thank you,

Seth Berl, M.D.

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CMS: I have utilized impedance technology for a three years and am in full support of expanding the indication for hypertension. I have a busy internal medicine practice with numerous patients that have had their BP controlled because of this technology. Unfortunately, the way coverage currently reads, the majority of my patients with uncontrolled hypertension are not eligible for the test. Our practice is surprised why the indications for this low cost, non-invasive test are so restrictive, especially when impedance has been demonstrated to improves outcomes and is cost-effective. I sincerely hope CMS will reconsider the clinical data from the highest level of evidence based, randomized trials and the numerous positive clinical experiences of providers and expands the coverage for hypertensive patients who have not responded to lifestyle modifications and have failed to respond to initial therapy. I have numerous beneficiaries that have benefited from impedance but far more that have not been allowed access to this important technology.

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Dear CMS,

I am submitting this comment regarding hypertension coverage for Bioimpedance, CPT 93701. I request that CMS provide national guidelines allowing for coverage of hypertensive patients on 2 or more drugs and remove the discretion by carrier limitation. The current NCD has led to inconsistent coverage guidelines for resistant hypertension. Unfortunately I live in New Jersey and Empire has made the determination not to cover for hypertension; Consequently, my patients do not have the same level of care as Medicare beneficiaries in other states. Bioimpedance has demonstrated to improve BP control in in two randomized controlled clinical trials, including the 11 site, community-based study published in April 2006, as well as observational studies. There is more high quality, randomized trial information supporting the use of TEB to improve BP control than some other technologies you have recently covered, including t-wave alternans. Please apply the same evidence based criteria you have in recent decisions. Bioimpedance has received unusually restrictive coverage and CMS is continuing this practice. I thank you for consideration of correcting this,

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To Whom It May Concern,
I am very disappointed with your draft decision not expand ICG coverage for hypertension. I am a practicing internist and have used ICG in my office for approximately 3 years. I attest that ICG has enabled me to manage my patients with resistant hypertension and other applications far more superior than if I had not had access to ICG on my patients. I find it very surprising that with a second randomized trial that you would not improve coverage by some means and recommend that a moderate improvement of national coverage on at least two medications. By the time a HTN patient is on two drugs and still uncontrolled, something different needs to be done. We have abysmally low control rate due to the fact that we are not more aggressive in treating HTN and the current JNC guideline are not effective at individualizing therapy. Based on two randomized trials, I urge you to find some means of expanding HTN coverage for this innovative technology.

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The ICG machine has helped me evaluate and treat hypertension and CHF patients. with the use of this machine I am able to accurately diagnose and perscribe the appropriate class of anti-hypertensive medication, I have seen dramatic results and have prevented patients from progressing into higher risk catagories. In 2-3 months I am able to determine if the meds perscribed are helping or worsening their BP, and can usually get them controlled. I am concerned that you have not fully evaluated the new clinical data and allowed for some improvement on the policy.

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