Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy

1a - I do not agree with this. Pt's are very unstable and sick after VAD implantation. We would see outcomes decrease significantly if pt's were to undergo a second major surgery when they have been so critically ill for so long. Our center gives our patient's time to recover from the surgery, recondition, increase their nutritional status and feel well enough to undergo another operation. Having the VAD also allows us to evaluate the pt for compliance for a longer period of time so we can be sure they will take care of such a precious gift as someone's heart. Many patient's receive a VAD emergently. Typically, those VADs do not meet DT criteria, but we feel they have strong potential to be a transplant candidates. However, if we are expected to actively list them and transplant them then we would need to complete a full work-up. These emergent patient's do not have the time for a full work-up, nor can they tolerate some of the testing. So we would be expected to let pt's die that we could have potentially helped or risk transplanting patients that may not have been an appropriate candidate had we had time to thoroughly work them up. If patients are actively listed and organs are being offered to these patients when they are too sick for transplant many of these offers will be declined. This will lead to a significant delay in finding a suitable recipient adn lead to loss of donor organs. This will also uneccessarily increase staff time for both the procurement agency's and recipient's Transplant Team as they will be managing more offers that would not be accepted. Allowing the patient to remain inactive until the Transplant Team feels they are ready will allow the organ offers to go to recipients that are ready for surgery and are likely to accept the offer if appropriate, therefore decreasing uneccessary staff workload. I agree with specifying that they are on the list maintained by the OPTN, but should have the ability to leave them as inactive until we feel they are safe enough for transplant and have had the benefit of a full evaluation. The argument that a patient shouldn't be maintained on the list if a suitable organ is available is a dangerous approach. It is trying to make a round shaped cookie cutter Plan of Care fit a population of asymmetrical patients with very unique needs and problems. The Transplant Team should be given the ability to make patient specific decisions regarding their care and do what is best for the patient to promote best patient outcomes, not what a panel of people have decided is best for all patients. Allow these highly specialized teams to do what they are trained to do.

2d - I strongly agree with this proposal. The INTERMACS Registry is not beneficial. It does not encompass 100% of your patient population. It is extremely labor intensive and what little knowledge is gained from the Registry certainly doesn't out weigh the amount of work that goes in to it. Our center has to track all pertinent VAD stats separately as the Registry is not a true reflection of our program data. We are mandated to participate, which requires a large annual fee, and the amount of FTE's required to maintain the web site not only wastes a significant amount of money, it is a huge waste of time that staff relevant to the program could spend in a far more constructive manner. In addition to the Registry, DT Certified centers are also required to enter data montly on the JC website, based on the centers PI's. This data is far more relevant and accurate as it will encompass your entire program.

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Dear Dr. Jacques:

On behalf of the International Consortium of Circulatory Assist Clinicians (ICCAC), we are formally submitting our comment on the National Coverage Determination (NCD) for the VAD coverage requirements addressed in the Artificial Hearts and Related Device NCD manual. The ICCAC represents an international community of practice of Mechanical Circulatory Assist/LVAD Coordinators. Our mission statement includes advocacy for this unique patient population. ICCAC encourages CMS to use the opening of the NCD to align Medicare coverage for Ventricular assist devices with current clinical practices. We urge CMS to create comprehensive VAD coverage for patients to be implanted as "treatment for end stage heart failure" refractory to medical therapy and remove the arbitrary designation and “active listing’ requirements prior to implant.

The advances in mechanical circulatory support (MCS) technology have enabled VAD implanting centers to support thousands of heart failure patients for an extended period of time. Access to this technology has saved lives, moving hospital-bound patients to becoming thriving members of society.

We acknowledge that originally VADs were available only to patients on the transplant list, limiting this advanced treatment of heart failure to transplant candidates needing to be bridged to transplant until a donor organ could be identified. REMATCH, the paradigm-shifting study from over a decade ago, expanded the indication for MCS to patients who were not transplant candidates through the concept of destination therapy (DT).

In the continuous flow (CF) device era, we are able to treat many patients with advanced heart failure with VADs. However, to date we are not able to consistently predict whether, following implant, a patient will qualify as a heart transplant candidate. Some who were initially deemed to meet transplant criteria may fail to meet those same criteria after implant. Similarly, those initially thought not to be candidates may improve enough with LVAD support to then qualify for a transplant.

Therefore, we believe that cleaving the connection between mechanical circulatory support and heart transplantation will be in the patient’s best interest. Once the patient has completed the evaluation for MCS and has been implanted (or been denied the therapy), independent consideration for heart transplantation can be undertaken. This strategy would prevent confusion for the patient and family and would allow them to focus on the therapy at hand. Further, linking deployment of mechanical circulatory support therapy to restrictive reimbursement definitions may also delay care while transplant candidacy is determined, placing the patient at risk of worsened post implant outcomes due to the delay.

Commercial Payor coverage policies recognize patients that are eligible or potentially eligible for a heart transplant, without requiring the patient to be listed as a transplant candidate. Furthermore, the Food and Drug Administration approved indication for VAD therapy as a bridge to heart transplant, based on clinical trial data, also does not delineate a required listing status prior to VAD implantation. The proposed CMS BTT criteria are not applicable to the reality of the clinical practice that providers are faced with today.

The CMS requirement that a patient be approved and “actively listed” or placed within a designation that can change on a day to day basis not only poses unnecessary risk and delay to care, but also forces centers to make premature decisions and create confusion and false hope to families and patients. We also encourage consideration for coverage for Cardiac Rehabilitation for VAD patients as this improves quality of life and outcomes. We look forward to your response.

Respectfully submitted,
Tonya Elliott, RN MSN,
President- Elect ICCAC

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August 30, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mail stop: C1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)

Dear Dr. Jacques,

On behalf of The Society of Thoracic Surgeons (STS), the largest organization representing cardiothoracic surgeons in the United States and internationally, I write to provide comments representing the Society’s response to the recently announced Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R). STS appreciates the opportunity and privilege to provide a unique perspective to this important therapy for our patients with advanced heart failure.

About STS

STS is a not-for-profit organization representing more than 6,700 cardiothoracic surgeons, researchers, and other health care professionals who are dedicated to ensuring the best possible outcomes for surgical therapies for the heart, lung, and esophagus, as well as other procedures within the chest. The Society’s mission is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. STS has been a strong advocate for a number of important improvement initiatives on quality outcomes and patient safety. One of the most notable is the STS National Database, which was established in 1989. The STS National Database houses more than 5.1 million surgical records and has been involved in several important collaborations with CMS, the FDA, and other agencies.

STS has the following specific responses to the CMS Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy.

Regarding:

1. Ventricular assist devices (VADs) for bridge to transplant (BTT)
   
   1. For the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, we clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network.
   
   
   2. Remove the existing requirement that a "Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available."

STS believes the proposed requirement by CMS to require active listing for heart transplantation for bridge to transplant indication requires further clarification. As stated, CMS is requiring that a patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network (OPTN) for bridge-to-transplant indication. STS believes that this requirement should be clarified to read: “For the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, we clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network at the time of VAD implantation. The Medicare-approved heart transplant center should determine patient-specific timetables for transplantation based upon ongoing patient assessment”. It is important to note that many VAD recipients, despite meeting all qualifications for heart transplantation and listed for heart transplantation at the time of VAD implant, may not be suitable candidates for transplantation immediately following VAD implantation and may need a period of time to recover from VAD implant surgery before being a suitable candidate to undergo heart transplantation. Further, during the course of VAD support, a patient may incur a significant adverse event, e.g., stroke, in the post-implant phase that permanently or temporarily alters transplant status. During these times, Medicare-approved heart transplant centers may elect to place patients at a low waitlist priority (e.g., United Network of Organ Sharing (UNOS) Status 2) or place patients at UNOS status 7 (i.e., hold status) to rehabilitate the patient from VAD surgery or resolve the adverse event and prevent the Medicare-approved heart transplant center from receiving donor offers on these patients. Acceptance rates of donor organs at the Medicare-approved heart transplant center would be adversely affected and importantly not reflect true acceptance rates of donor organs at a Medicare-approved heart transplant center if patients are not triaged to the appropriate transplant urgency status reflecting the medical condition of the patient and suitability for heart transplant. It is inappropriate to maintain a patient at a high priority for transplant (e.g., UNOS Status 1A or 1B) if the patient is not suitable for transplant following VAD implantation and the Medicare-approved heart transplant center cannot expedite transplantation due to changes in the medical condition of the VAD recipient following VAD implantation. The CMS rule should be clarified to permit centers to alter transplant listing status in the post-implant phase to represent appropriate changes in the patient’s medical condition and reflect the dynamic process of ongoing transplant candidacy assessment (Acker et. al. Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States. Ann Thorac Surg 2012; 94:2147–58).

Assessment of Transplantation Status at the Time of VAD Implant

Real world use of VADs has promoted the development of a colloquially-defined Intention-to-Treat paradigm called “Bridge-to-Decision” or Bridge-to-Candidacy.” We believe that the proposed Intention-to-Treat categories of VAD use that CMS has recommended as covered are appropriate. However, we also believe that what needs to be fully considered are the Intention-to-Treat transitions. These transitions are indeed a real world observation and accepting only Bridge-to-Transplant and Destination Therapy as the covered indications could lead to tailoring patients into false indications to accomplish coverage, or more importantly to denial of therapy for a critically ill subset of patients who would otherwise obtain survival benefit with VAD therapy.

The requirement to submit data to a national registry (e.g., INTERMACS) has provided an important perspective and clarification of a VAD recipient’s Intention-to-Treat status and has identified, with significant granularity, the likelihood of a VAD recipient becoming a “listed” heart transplant candidate versus a candidate for Destination Therapy. This is a dynamic process whereby patients with compromising heart failure can transition between these accepted definitions of intentions to treat based upon resolution or development of risk factors and comorbid conditions that influence transplant probability and survival. Herein lies the importance of maintaining the viability of a complex data registry which is able to provide long-term longitudinal data on those patients undergoing transitions of Intention-to-Treat.

Maintenance of a well-managed national VAD registry will continue to provide critical information regarding the utilization of VADs in this regard. “The current indications of Bridge-to-Transplant and Destination Therapy have limitations and create disparities in device access for patients” (Acker et. al. Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States. Ann Thorac Surg 2012; 94:2147–58).

Regarding:

2. VADs for destination therapy (DT)
   
   1. The evidence is insufficient to support changes to our current patient selection criteria for coverage of a VAD as DT.

STS supports the conclusion by CMS that there currently exists insufficient data to support changes to the current patient selection criteria for coverage of a VAD as DT. However, STS believes this conclusion reached by CMS regarding insufficient data to support changes to the current patient selection criteria for coverage of a VAD as DT strongly supports the need for continued rigorous collection of data on VAD recipients through a national registry. STS believes that as the field of mechanical circulatory support continually matures, there will be ongoing identification of patient characteristics that will identify low or high risk subgroups of patients undergoing VAD implant. The dynamic process of identifying high and low risk patient characteristics requires ongoing data collection. STS believes that withdrawal of the current policy mandating participation in a national registry will adversely influence quality of care and cost of care delivered to patients in the future.

What the policy of mandating submission of data on VAD recipients to a national registry has accomplished for the field of mechanical circulatory support regarding patient selection criteria for coverage of a VAD as DT

The mandated submission of data to a national registry helped to develop a preoperative risk assessment scale (e.g., INTERMACS Patient Profiles; Stevenson et. al. J Heart Lung Transplant 2009; 28:535–41) that has identified characteristics of high risk patients undergoing VAD implant. INTERMACS has identified that patients assigned to a high risk profile do poorly relative to other groups following VAD implant. Identification of this high risk profile has significantly changed physician behavior with respect to timing of VAD implant and has moved physicians to identifying patients for VAD implant at a less advanced stage of heart failure but within patient selection criteria required by CMS. This change in physician behavior has been well documented and represents a significant and successful patient quality initiative. This improvement in identifying the appropriate timing of VAD implantation has significantly increased survival following VAD implant and importantly, has likely reduced the cost of VAD implant to patients, including Medicare beneficiaries. It is likely that continued rigorous data collection will lead to identification of other high risk characteristics that could influence physician behavior regarding candidate selection for VAD implant as well as inform CMS to important coverage decisions.

Regarding:

2. VADs for destination therapy (DT)
   
   2. The evidence is sufficient to conclude that VADs implanted in facilities that meet certain criteria improve health outcomes for Medicare beneficiaries. Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities for a period of one year following the posting of the final decision memorandum. At the conclusion of this transition period, these facilities must be in compliance with the following criteria as determined by the credentialing organization. As of the effective date, new facilities, must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A): Printed on 8/10/2013. Page 1 of 106
      
      1. Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD. The team must include, at a minimum, all of the following:
         
         • At least one physician with cardiothoracic surgery privileges and individual experience implanting at least 10 VADs over the course of the previous 36 months with activity in the last year.
         
         
         • At least one cardiologist trained in advanced heart failure with clinical competence in medical and device-based management including VADs, and clinical competence in the management of patients before and after heart transplant.
         
         
         • A VAD program coordinator.
         
         
         • A social worker.
         
         
         • A palliative care specialist.
         
         
      2. Facilities must track patient outcomes including survival, adverse events (e.g., bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement.
      
      
      3. Facilities must be credentialed by an organization approved by CMS.

STS supports CMS’ decision on the description and components of an experienced multidisciplinary heart team that is dedicated to the treatment and care of patients with advanced heart failure requiring VAD therapy. STS agrees that patients being cared for by an experienced multidisciplinary heart team have improved health outcomes.

STS maintains that the development of criteria for VAD surgeon certification is a task best accomplished through the peer reviewed processes maintained by STS, the specialty’s largest national society. The Society has developed a “Clinical Statement on the Requirements for Surgeon Certification for Implantation of Durable Ventricular Assist Devices” which addresses the recommended criteria for VAD Surgeon Certification. This collaborative document represents the opinions of a broad constituency of board-certified cardiothoracic surgeons in the US. The criteria were developed to address a number of important limitations in the interpretation of current CMS requirements for implantation of durable VADs overseen by the Joint Commission. (Pagani et. al. Certification for Implantation of Durable, Implantable Ventricular Assist Devices in the United States: The Need for Clarification of the Process. Ann Thorac Surg 2013; 95:1520-1522; Acker et. al. Clinical Statement on the Requirements for Surgeon Certification for Implantation of Durable Ventricular Assist Devices (VADs) Ann Thorac Surg 2013; 95:1834-1839).

The goals of the proposed criteria for surgeon certification are to: 1) establish a minimum standard of training and experience to help ensure competency in the technical aspects of VAD implantation and VAD patient management; 2) establish a pathway by which operative and patient care experiences obtained during an ACGME-approved Thoracic Surgery residency or advanced fellowship in cardiac surgery are credited to the CMS volume criterion; 3) establish a pathway by which international or foreign operative and patient care experiences are credited toward the CMS volume criterion; 4) address the unique practice environment of pediatric cardiothoracic surgeons with respect to the volume criterion; 5) address issues of maintenance of VAD certification; and 6) provide clarification of the term “primary surgeon” to provide credit for educational experiences obtained in an ACGME-approved Thoracic Surgery residency, advanced cardiac surgery fellowship or in clinical practice as a board-certified cardiothoracic surgeon.

With reference to requirement 2.B.ii, STS believes that in order for centers to continue to track patient outcomes including survival, adverse events (e.g., bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement would be through continued mandated participation in a national registry. STS endorses the process of quality improvement initiatives through participation in national registries.

Furthermore STS believes that such registries should be characterized in the following way.

1. Be able to capture the required information as outlined in Section 2 (ii) in a longitudinal fashion. Most important in this regard are survival, quality of life, and functional status as well as key adverse events such as bleeding, infection, neurological dysfunction, device malfunction and cardiovascular complications including recurrent heart failure. Collection and analysis of these data points may allow the development of risk adjustment models which can be utilized in patient selection and management.


2. Provide information for the above metrics in a way that reflects not only in-hospital metrics but also long-term metrics for the life of the patient while on the VAD.


3. Maintain an active auditing process that ensures capture of all patients on VADs as well as quality and completeness of data.


4. Provide at least quarterly data reports on trends in survival and patient characteristics with critical outcome metrics as mentioned above that can be utilized for regulatory purposes in the site accreditation process.


5. To serve as a reporting mechanism for determination of credentialing milestones for regulatory agencies that will deem site credentialing as a Destination Therapy VAD center.


6. Provide appropriate risk modelling that allows sites to be compared on patient population characteristics for key outcome metrics. This modeling has to be sensitive to changes in therapeutic application as well as new devices.


7. Provide a pathway for reporting to the FDA through the MDR reporting process.

With reference to requirement 2.B.iii, STS supports CMS’ decision to require certification of a center to provide VAD therapy by an organization approved by CMS.

Regarding:

2. VADs for destination therapy (DT)
   
   3. We propose to remove the separate requirement that hospitals have in place staff and procedures for appropriate informed consent as this requirement is encompassed in the above team definition.

STS supports CMS’ decision to remove separate requirements that hospitals have in place staff and procedures for appropriate informed consent as this requirement is encompassed in the above heart team definition.

Regarding:

2. VADs for destination therapy (DT)
   
   4. The evidence is sufficient to conclude that continuing required participation in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) will not adequately address the outstanding evidentiary questions for VADs; therefore, INTERMACS participation is no longer required for VADs to be determined reasonable and necessary and CMS proposes to remove this requirement.

STS believes there remains a significant number of questions regarding coverage decisions and characteristics of patients undergoing VAD implant that require further clarification through a policy that mandates continued center participation in a national registry, such as INTERMACS.

Importantly there remain significant discrepancies between FDA-approved indications for use and current CMS coverage decisions. Specifically, current devices approved for destination therapy have been approved for patients with New York Heart Association (NYHA) functional class IIIB and IV symptoms. Data supporting the use of devices for patients with NYHA functional class IIIB limitations were obtained in an FDA-approved pivotal clinical trial (Slaughter et. al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009; 361:2241-51). However, despite inclusion of patients with NYHA functional class IIIB symptoms in the indication for approval for VAD therapy by FDA, CMS has determined these data are insufficient to be informative regarding coverage decisions. STS believes, that a policy that mandates continued submission of data to a national registry, such as INTERMACS could inform CMS in the future regarding a coverage decision for this subgroup of patients. INTERMACS has collected data on the largest cohort of patients with less advanced heart failure with patient characteristics similar to those enrolled in the HeartMate II Pivotal Trial for Destination Therapy. These data could confirm or dispel observations on the outcomes of patients with NYHA functional Class IIIB limitations and additionally support observations from future controlled randomized pilot clinical trials such as REVIVE-IT (Randomized Evaluation of VAD Intervention Before Inotrope Therapy).

Determination of transplant status at the time of VAD implantation remains a significant clinical challenge. CMS and FDA have not recognized the strategy of the use of VADs as a bridge-to-decision or bridge-to-candidacy for heart transplantation. INTERMACS has collected significant data on the strategies employed by clinicians at the time of VAD implantation and has identified patients characteristics and outcome within these strategies. Based upon patient characteristics at implant, significant data exists to determine the likelihood and probability of transplant. We believe these data are critical to CMS to inform CMS on future decisions as to validity of these implant strategies.

Regarding:

2. VADs for destination therapy (DT)
   
   5. We propose to allow organizations that have credentialing programs specific to VADs to apply to CMS to be designated as a credentialing organization for VAD facilities for DT. These programs must ensure that credentialed facilities meet the criteria outlined in the NCD and may include additional requirements necessary to operationalize these criteria or administer the credentialing program. Beyond this, any additional substantive credentialing standards not identified in the final NCD are not required for Medicare coverage.

      The process for organizations to apply for CMS approval to be designated as a credentialing organization for VAD facilities for DT will be posted on our web site along with a list of approved credentialing organizations, approved standard versions, and credentialed facilities. http://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/VAD-Destination-Therapy-Facilities-Aug2007.html.

STS supports CMS’ decision to allow organizations that have credentialing programs specific to VADs to apply to CMS to be designated as a credentialing organization for VAD facilities for DT.

Regarding:

3. We propose to add a statement that the NCD does not address coverage of VADs for right ventricular support, biventricular support, use in patients under the age of 18, or use in patients with complex congenital heart disease and that coverage for items and services under section 1862(a)(1)(A) in these situations will be made by local Medicare Administrative Contractors (MACs) within their respective jurisdictions.

STS is requesting CMS to clarify the above language to reflect the use of durable, long-term VADs approved for left ventricular support only and not to situations where approved temporary VADs are utilized for perioperative support of the right ventricle at the time of LVAD implant for management of biventricular failure. Further, the Thoratec pVAD (Thoratec Corporation, Pleasanton, CA), Thoratec IVAD (Thoratec Corporation, Pleasanton, CA) and Berlin Pediatric Excor (Berlin Heart, Germany) are devices designed to support left and/or right ventricles and are appropriate devices to manage biventricular failure including situations noted above by CMS.

Other Benefits of a National Registry for Collection of Data on VAD Therapy

INTERMACS was established under a joint federal partnership with the National Heart Lung Blood Institute (NHLBI), FDA and CMS in addition to partnerships with industry and academia. This coalition has created a unique collaboration that has accomplished a number of major advances in the field of mechanical circulatory support. A national registry such as INTERMACS has a number of components that make it a valuable resource for benefiting the federal partnership including: 1) has in place mechanisms for the transparency of data elements and specifications, risk models, and measures; 2) requires the submission of data from participants with respect to multiple payers; 3) provides timely performance reports to participants and in the future provide this information at the provider-specific level; 4) supports quality improvement initiatives for participants; 5) has a standardized, nationally benchmarked tool for assessing the care of patients undergoing VAD implant procedures; 6) provides the opportunity to participate in national quality improvement efforts for VAD therapy that have an impact at the local, regional, and national levels; 7) provides a mechanism to target specific areas for clinical practice improvement; 8) has the ability to investigate regional and national practice patterns in VAD therapy surgery; 9) has the ability to conduct clinical and comparative effectiveness research using a national aggregate data set; 10) provides benchmarking capacity for assessing the care furnished to patients by the clinical sites and in the future, eligible professionals participating in the qualified clinical data registry, and 11) has the ability to provide timely and frequent feedback to its eligible professionals.

Partnership with Academia

MEDAMACS

MEDAMACS represents a medical observational arm within INTERMACS that will provide unique data on patient outcomes for patients initially triaged to medical management for the treatment of advanced heart failure. MEDAMACS will provide an observational arm of patients initially triaged to medical therapy that will provide a comparative observational control group to patients with similar characteristics undergoing VAD implant. These data could inform CMS on coverage decisions regarding therapy in less advanced stages of heart failure and complement data obtained from randomized clinical trials.

PediMACS

PediMACS represents a pediatric-dedicated registry within INTERMACS. PediMACS investigators have developed unique outcome measures specific to the pediatric population including modification adverse event definitions. The accumulation of data within PediMACS will provide significant opportunities to assess outcomes in this population.

PumpKIN (Pumps in Kids, Infants and Neonates)

PumpKIN is a NHLBI initiative to investigate the use of new VAD and extracorporeal life support technology for the pediatric population. INTERMACS will provide observation control data for the VAD treatment arm of PumpKIN from data from registrants entered into PediMACS. PumpKIN is a landmark initiative in the field of pediatric mechanical circulatory support.

REVIVE-IT

The REVIVE-IT (Randomized Evaluation of VAD InterVEntion Before Inotrope Therapy) Trial is one of the most important clinical trials since REMATCH and will investigate the use of VAD therapy for DT in a population of patients with less advanced heart failure then currently receiving VAD therapy. The REVIVE-IT Trial is an NHLBI-sponsored trial that is significantly supported by INTERMACS as a requirement of FDA. FDA requires that all patients receiving device therapy in the REVIVE-IT trial be followed by INTERMACS following the 2-year assessment of the primary outcome in the REVIVE-IT Trial. Without INTERMACS serving as the registry for long-term followup, the REVIVE-IT study may not be feasible due to cost implications. Further, data from the REVIVE-IT Study will also be transferred to INTERMACS to provide further data on patients receiving VAD therapy at less advanced stages of heart failure. REVIVE-IT Trial is designed as a pilot trial and will provide a limited amount of data on only 100 patients randomized to optimal medical management or VAD therapy. Complimentary data from MEDAMACS and INTERMACS could therefore inform CMS on coverage decisions for VAD therapy for DT indication in less advanced stages of heart failure.

Partnership with Industry

STS believes that a significant new source of data to inform CMS coverage decisions will come through randomized clinical trials or unique trial designs incorporating contemporaneous control groups. National registries such as the transcutaneous valve registries or INTERMACS are uniquely positioned to support rigorous collection of data through randomized clinical trials or trials utilizing unique trial designs with contemporaneous control groups.

Summary Statement

Participation and utilization of the INTERMACS registry continues to evolve with the need to strengthen emphasis on its optimal impact and application in real time clinical decision making and incorporation into quality improvement initiatives. However, as the utilization and use matures, there are a number of critical advantages to maintaining a registry as a requirement for CMS reimbursement.

Sincerely,

Douglas E. Wood, MD
President

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The sub-division of patients in need of mechanical circulatory support into BTT, DT, and BTC is a practice based on regulatory, political, and economic factors rather than science. The proposed changes to the current national coverage determination (NCD) only perpetuate this. Whether or not VAD therapy is available to a Medicare patient should be based on medical need for mechanical circulatory support, in this case the degree of heart failure and freedom from contraindications, not the medical qualification for a different therapy (transplant) that is not available at the time and may never be.

The criteria for transplant listing were developed to serve the public need for fair allocation of scarce donor organs, and involve fundamental differences in available options than for MCS. Almost always, no donor organ is available at the time of the transplant committee’s listing decision, but a mechanical device is. The condition of listed patients often changes before a donor is available; whereas the MCS patient could receive a device promptly based on medical judgment of his/her present condition. If there were 10,000 heart donors available each year instead of 2,500 there is no doubt that there would be four times as many listed transplant candidates.

I urge CMS to modify its determination so as to approve payment for patients who are in need of mechanical circulatory support, are free of contraindications for MCS, and who would be able to be successfully transplanted if a donor were available, without requiring that the patient be on the waiting list of the Organ Procurement and Transplantation Network prior to device implant.

This removes the transplant committee as a gate keeper for VADs. Recall that the committee as gatekeeper of donor allocation was established to optimize the utilization of scarce donor hearts. There is not a scarcity of VADs, and their use involves different considerations than transplant.

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The Joint Commission appreciates the opportunity to provide comments on CMS’ Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R). The Joint Commission has been the sole certifying body for facilities seeking Medicare reimbursement for the implantation of VADs used for destination therapy (VAD-DT) since 2007. The Joint Commission has certified 124 VAD-DT programs across the U.S. The Joint Commission strongly supports the need for an external body, such as an accrediting organization, to certify VAD programs compliance with a set of rigorous requirements. Such a process improves the quality of patient care by reducing variation in clinical processes and provides an objective assessment of a programs systems and processes of care. Below are specific comments for CMS’ consideration.

CMS’ Proposal. In the summary of the proposed decision memorandum, CMS reiterates that “the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center” and “that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network.” In addition, CMS also proposed to remove the requirement that a "Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available."

The Joint Commission’s Response: The Joint Commission agrees that bridge to transplant (BTT) patients should be listed as a candidate for a heart transplant by a heart transplant center. The Joint Commission has a requirement that the ventricular assist device (VAD) program must have a relationship with a heart transplant center and that all patients, that are clinically stable, are evaluated for a heart transplant; this must be documented in the medical record

CMS states that “The evidence is insufficient to support changes to our current patient selection criteria for coverage of a VAD as DT.”

The Joint Commission’s Response: The Joint Commission supports CMS’s current patient selection criteria. The Joint Commission also requires an interdisciplinary approach for determining patient eligibility for VAD placements and further treatment options during the post-implant reevaluation. The Joint Commission understands that the field of VAD implantation is evolving, the devices are changing and that may warrant a more frequent assessment of the relevancy of patient selection criteria. It is important that the criteria remain consistent with the evidence now and in the future.

CMS’ Proposal. CMS notes that “The evidence is sufficient to conclude that VADs implanted in facilities that meet certain criteria improve health outcomes for Medicare beneficiaries. Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities for a period of one year following the posting of the final decision memorandum.” CMS proposes that “At the conclusion of this transition period, these facilities must be in compliance with the following criteria as determined by the credentialing organization. As of the effective date, new facilities, must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A):

i. Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent.

ii. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD. The team must include, at a minimum, all of the following:

• At least one physician with cardiothoracic surgery privileges and individual experience implanting at least 10 VADs over the course of the previous 36 months with activity in the last year.


• At least one cardiologist trained in advanced heart failure with clinical competence in medical and device-based management including VADs, and clinical competence in the management of patients before and after heart transplant.


• A VAD program coordinator.


• A social worker.


• A palliative care specialist.”

The Joint Commission’s Response: The Joint Commission agrees that a multidisciplinary team of medical professionals with appropriate qualifications, training, and experience should provide comprehensive patient care. The Joint Commission requirements are equivalent to the proposed NCD in that the interdisciplinary VAD team must be comprised of these disciplines.The Joint Commission supports including other specialized health care providers based on patient and family needs.Through research and discussions with experts in the field, The Joint Commission’s 2014 VAD requirements include financial services, nutrition, palliative care, psychological services, and rehabilitative services to be part of the team when warranted. The Joint Commission believes these inclusions provide a patient-centered approach for the patient receiving a VAD for destination therapy. The Joint Commission supports a collaborative approach and demonstrates this by requiring VAD programs to have an interdisciplinary team who work collaboratively in patient selection and outpatient management of the VAD patients. The team also needs to ensure continuity of care and a more effective transition of care to the home for the VAD patient. In addition, Joint Commission requirements specify the education, experience, training, and certification that the team should have. These requirements support a competent and experienced team that can provide the complex care these patients needs. For example, a VAD coordinator must have experience and expertise in the complete course of treatment of a VAD patient; the cardiologists and cardiac surgeon are required to be privileged by the organization.

CMS’ Proposal. CMS proposes that “Facilities must track patient outcomes including survival, adverse events (e.g. bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement.”

The Joint Commission’s Response: The Joint Commission agrees that facilities must track patient outcomes. In its requirements, the Joint Commission requires VAD programs to track survival rates, adverse events (e.g., bleeding, infection, stroke, device malfunction, and readmission), functional status, and quality of life. In its new 2014 VAD requirements, The Joint Commission will require VAD programs to include in their quality improvement programs the tracking of readmission for this population so that the program can investigate the reasons its population is being readmitted. In addition, the Joint Commission will require VAD programs to track device recalls and warnings from the manufacturer.

CMS’ Proposal. CMS proposes that “Facilities must be credentialed by an organization approved by CMS.”

The Joint Commission’s Response: As noted above, the Joint Commission supports the credentialing of facilities for VAD for DT. Because the environment around VADs is evolving and changing rapidly, it is important to ensure that organizations comply with recognized standards of care, provide safe quality care, and verify the competency of their staff in order to protect this patient population from less than adequate programs. The Joint Commission conducts a rigorous evaluation of a VAD program, and its requirements exceed many of those within the NCD, as the NCD provides for minimum standards. We believe that the rigor of our certification program helps ensure the quality of care patients receive and reduces the financial burden of the Medicare program. It is the Joint Commission’s policy to permit a VAD certification review of any Medicare-approved hospital, regardless of its relations to a non-Joint Commission hospital accrediting body. Currently, the capacity to do additional reviews is also not an issue because The Joint Commission has built a robust cadre of well-trained surveyors. While we support general competition among hospital accrediting bodies, we believe there is value in having a single CMS approved VAD certifier for such a technical and challenging area.

CMS’ Proposal. CMS proposes to remove the separate requirement that hospitals have in place staff and procedures for appropriate informed consent as this requirement is encompassed in the above team definition.

The Joint Commission’s Response: The Joint Commission agrees that it is important to have an interdisciplinary team approach for obtaining informed consent. The informed consent process is important to ensure that there is a patient-centered approach to care. The Joint Commission’s informed consent requirements include discussion of alternative treatment options, current survival and functional expectations after VAD implant, and patient expectations for the VAD implant.

CMS’ Proposal. CMS notes that “The evidence is sufficient to conclude that continuing required participation in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) will not adequately address the outstanding evidentiary questions for VADs; therefore, INTERMACS participation is no longer required for VADs to be determined reasonable and necessary and CMS proposes to remove this requirement.”

The Joint Commission’s Response: The Joint Commission believes that facilities should participate in a nationally audited registry. The data that is collected from the registry is beneficial for evaluation of patient outcomes nationally and to help inform future interventions for this patient population. The Joint Commission requires VAD programs to participate in a nationally audited registry, and acknowledges that INTERMACS is currently the only one. The Joint Commission recommends that CMS retain this requirement in the final VAD for DT NCD.

CMS’ Proposal. CMS proposes “to allow organizations that have credentialing programs specific to VADs to apply to CMS to be designated as a credentialing organization for VAD facilities for DT. These programs must ensure that credentialed facilities meet the criteria outlined in the NCD and may include additional requirements necessary to operationalize these criteria or administer the credentialing program. Beyond this, any additional substantive credentialing standards not identified in the final NCD are not required for Medicare coverage.

The process for organizations to apply for CMS approval to be designated as a credentialing organization for VAD facilities for DT will be posted on our web site along with a list of approved credentialing organizations, approved standard versions, and credentialed facilities. http://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/VAD-Destination-Therapy-Facilities-Aug2007.html.”

The Joint Commission Response: As noted above, the Joint Commission supports the use of an external body to certify, through the use on an onsite survey, VAD programs compliance with a set of rigorous requirements. Because the environment around VADs is evolving and changing rapidly, it is important to ensure that organizations comply with recognized standards of care, provide safe quality care, and verify the competency of their staff in order to protect this patient population from less than adequate programs. The Joint Commission conducts a rigorous evaluation of a VAD program, and its requirements exceed many of those within the NCD, as the NCD provides for minimum standards. This rigor helps to ensure that VAD patients receive high quality and safe care; it also helps to reduce the financial burden of the Medicare program. For this very technical and complex arena, the Joint Commission encourages CMS to consider the value of having a single CMS-approved certifying for VAD-DT Programs.

CMS’ Proposal. CMS proposes “to add a statement that the NCD does not address coverage of VADs for right ventricular support, biventricular support, use in patients under the age of 18, or use in patients with complex congenital heart disease and that coverage for items and services under section 1862(a)(1)(A) in these situations will be made by local Medicare Administrative Contractors (MACs) within their respective jurisdictions.”

The Joint Commission’s Response: The Joint Commission supports CMS’ effort to clarify the patient population that is covered by this NCD; it will help to differentiate programs that require certification from those that are not eligible under the conditions set forth in the NCD.

We appreciate the opportunity to provide this information to CMS. If you have any questions, please feel free to contact me at pkurtz@jointcommission.org.

Sincerely,

Patricia Kurtz
Deputy Director, Washington DC Office

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The MedStar Heart Institute at Washington Hospital Center is pleased to submit these comments on the National Coverage and Analysis (NCA) tracking sheet for ventricular assist devices for bridge to transplant (BTT) and destination therapy (DT). The MedStar Heart Institute at MedStar Washington Hospital Center has been awarded the quality of excellence award as one of the top hospitals in our region from the Delmarva Foundation, a national nonprofit that works to improve health care standards. Our physicians are motivated by the hope for a better tomorrow where surgery is less invasive and medical technologies, such as ventricular assist devices, provide an effective solution for heart failure patients to live longer and fuller lives.

The FDA-approved BTT indication for VADs is for use in patients who are at risk of death from refractory end-stage left ventricular heart failure and eligible for cardiac transplant. The FDA indication for use language does NOT include a listing requirement. CMS has chosen to add this additional layer of complexity. The fifth INTERMACS annual report analysis of the intent to implant from January to June 2012 showed of the 189 recipients, 21% were listed as BTT, 22% as likely BTT and 9% as moderately likely to proceed with BTT. This data confirms that the current clinical practice regarding BTT VAD therapy is not congruent with the CMS-proposed criteria that the patient must be active on the wait list and maintained by the Organ Procurement Network. In addition, with the limited number of donor hearts, in most patients the question of transplant eligibility should be addressed post LVAD implantation as is done universally outside the United States. This allows the recipient to be evaluated with complete candor when they are clinically stable and potential contraindications such as pulmonary hypertension, and relative modifiable risk factors such as cigarette smoking, has been corrected. It allows the use of this life-saving therapy in patients prior to a clear distinction between whether the patient is more appropriate in the bridge to transplant or destination therapy category.

Thank you on behalf of the MedStar Heart Institute MedStar Washington Hospital Center for allowing us to comment on your proposed changes in the National Coverage Decision.

Steven W. Boyce, M.D.
Director LVAD program & Surgical Director of Heart Failure

Paul J. Corso, M.D.
Chair, Department of Cardiac Surgery
Chair, MedStar Heart Institute

Samer Najjar, M.D.
Director, Advanced Heart Failure Program

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August 30, 2013

Dr. Louis Jacques
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

VIA ELECTRONIC DELIVERY

Re: Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)

Dear Dr. Jacques,

SynCardia Systems, Inc. (SynCardia) is pleased to submit these comments on the Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R) (Proposed Decision Memo). SynCardia is the manufacturer of the world's first and only Total Artificial Heart. As is the case with ventricular assist devices (VADs), facilities that are certified to implant the Total Artificial Heart participate in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).

As discussed herein, SynCardia believes that INTERMACS is an invaluable resource in the collection and dissemination of clinical information related to the use of mechanical circulatory support devices. We are concerned that the CMS proposal to require facilities to track outcomes on a facility basis is an inferior replacement for INTERMACS and insufficient to ensure that data relevant to coverage is systematically obtained and reported. We therefore urge CMS to continue to require facilities to participate in the INTERMACS registry as a requirement for coverage of VADs.

1. INTERMACS Participation Is Essential to Quality Assessment and Improvement and Therefore Should Continue to Be a Requirement for Coverage.

When the Centers for Medicare & Medicaid Services (CMS) first established coverage for VADs for destination therapy in 2003, it said that “Registry data can be an invaluable aid to an implanting facility in ongoing assessment of the quality of care it is providing to its patients.” (See reference 1 below) It continues to be the case, as CMS recognizes, that data collection is “necessary to inform program quality assessment and improvement (e.g., refinement of the procedure and post-operative care, ongoing assessment of quality of care, comparing facility experience against that of others).” (See reference 2 below)

Continued quality assessment via data collection is especially needed for high-risk procedures, such as VAD implantation, with significant morbidity and mortality. For these procedures, registry participation is still necessary because, as was true in 2003, “the device and post-operative care will continue to be refined in coming years and it is important to have a means of assessing the quality of patient care over time to ensure that outcomes are maintained or ideally improved.” (See reference 3 below) Registry participation is the most efficient and effective means of collecting such data and therefore should continue to be a requirement for coverage.

For example, through INTERMACS, a major increase in early mortality when implanting VADs in patients in cardiogenic shock was identified and led to a relatively rapid change in physician practice. (See reference 4 below) Similarly, when an increased risk of pump thrombosis requiring pump exchange in the HMII device was identified, the comprehensive analysis of national experience by INTERMACS indicated that, although significant, the magnitude of the increase was limited. This analysis prevented a major shift away from VAD use for patients whose only real chance for survival was device implant.

These examples underscore that changes in pump design, patient selection and patient management require long-term surveillance of a large sample of patients receiving implants in order to identify changes in outcomes that may affect coverage decisions. Pre- and post-market studies required by the Food and Drug Administration (FDA), or facility-level tracking proposed by CMS (discussed below), may not be sufficient.

Participation in INTERMACS is essential to achieving the goal of quality assessment and is most useful for coverage analyses. INTERMACS provides facilities with aggregate national data as well as detailed information about their own outcomes. These data provide benchmarks by which facilities can compare and improve their individual performance.

INTERMACS is also widely accepted and regarded in the medical field. For example, in a report to the Patient-Centered Outcomes Research Institute (PCORI) on standards for the conduct of registry studies for patient-centered outcomes research, INTERMACS is cited as an example of the how the standards should be applied. (See reference 5 below) Moreover, FDA has embraced the value of INTERMACS to provide device and patient data during post-market studies.

Contrary to the CMS statement that continuing participation in INTERMACS will not adequately address outstanding evidentiary questions for VADs, INTERMACS data have been relied on extensively by investigators in studies cited by CMS, as well as by CMS itself,. The INTERMACS information is, and can continue to be, used to make determinations about the reasonableness and necessity of VAD use and patient selection criteria, but only to the extent that participation in the registry continues to be required.

2. The CMS Proposal For Facility-Level Outcome Tracking Is Not Sufficient To Ensure that the Information Necessary for Coverage Determinations Will Be Captured

In lieu of requiring facilities to participate in INTERMACS, CMS is proposing to require facilities to track patient outcomes, including survival, adverse events (e.g., bleeding, infection, stroke and device malfunction), functional status, and quality of life, in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement. This is an extremely vague requirement that induces inconsistency. Without more guidance, facilities will have no way of knowing what is needed to allow comparisons with other institutions and it is likely that CMS would see less useful data than are currently available via INTERMACS. INTERMACS currently allows researchers to obtain information from a national database and nothing about the discussion in the Proposed Decision Memo suggests that a national database would develop from individual facility programs that track patient outcomes.

The proposed requirement advocates the idea of quality assessment and improvement without providing any real assurances thereof. Instead of receiving quarterly INTERMACS reports with detailed facility-level and national aggregate data, each facility will be required to institute its own tracking program and the more than 150 facilities performing VAD implants will have to resolve how to make their individual reports comparable. This seems very unlikely and CMS gives no indication of how the requirement will be enforced. Also, because each facility will house its own information, there will no longer be any way for researchers to obtain blinded information across providers that can be used for analyses.

3. CMS Should Seek to Upgrade INTERMACS, Not Dismantle It

SynCardia understands that CMS has concerns about INTERMACS and agrees that there are shortcomings. However, we believe that this registry should be modified over time, rather than dismantled. In SynCardia’s view, the Proposed Decision Memo lessens the value of INTERMACS participation. This is likely to diminish the value perceived by providers, decrease facility participation, and initiate a progressive decline that will lead to the erosion of INTERMACS as a source of clinical evidence.

We believe INTERMACS can be improved to address shortcomings. For example, major knowledge gaps will be addressed by the addition of dedicated pediatric (PEDIMACS) and medical (MEDAMACS) components within INTERMACS. Working with stakeholders to revamp INTERMACS, rather than discarding it completely and replacing it with an inadequately defined requirement that is unlikely to provide the same quality and quantity of data, seems ill-advised. CMS is correct in requiring outcomes tracking and quality assessments as prerequisites for coverage. The special attributes of VADs make these activities particularly important for procedures involving those devices. CMS should continue to require participation in INTERMACS to assure the availability of consistent and reliable clinical data that are broadly applicable to evaluation of coverage and quality of care.

As noted by Fred Resnic and Sharon-Lise Normand in The New England Journal of Medicine, INTERMACS is "[p]erhaps the most successful example of a coordinated effort to study newly introduced devices . . . Its success is related to the requirement by CMS that patient information be entered into an audited national registry as a condition of reimbursement." (See reference 6 below) Given the value of INTERMACS to date as a quality assessment tool for VADs, the need for continued monitoring in the future, and the questionable usefulness of the alternative CMS proposal, SynCardia urges CMS to continue to require INTERMACS participation for coverage under the VAD National Coverage Determination.

If you have any questions about these comments please contact me at mgarippa@syncardia.com or at 520-618-1853.

Sincerely,

Michael P. Garippa
CEO and President

References:
1 See Proposed Decision Memo at VIII.B.3.
2 Id.
3 Id.
4 Kirklin, JK, Naftel, DC, Kormos, RL, Stevenson, LW, Pagani, FD, Miller, MA, Baldwin, JT and Young, JB. “Fifth INTERMACS annual report: Risk factor analysis from more than 6,000 mechanical circulatory support patients”, J Heart Lung Transplant; Feb 2013: 32 (2): 141-156.
5 See Standards in the Conduct of Registry Studies for Patient-Centered Outcomes Research (Mar. 2012), at http://pcori.org/assets/Standards-in-the-Conduct-of-Registry-Studies-for-Patient-Centered-Outcomes-Research1.pdf.
6 See Resnic FS and Normand S. Postmarketing Surveillance of Medical Devices – Filling in the Gaps. N Engl J Med 2012; 366:875-877. Available at http://www.nejm.org/doi/full/10.1056/NEJMp1114865.

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The heart transplant and ventricular assist device team at The University of Maryland disagrees with the proposed policy change in regards to VADs for BTT.
It is incongruent with current practice of care to offer BTT VAD only to patients that are active on the heart transplant list. In most circumstances a patient that may be a candidate for heart transplant, that then receives a VAD, may either be temporarily inactive on the transplant list (status 7) or has not completed necessary evaluation to qualify for transplant or has one or two relative, modifiable risk factors for transplant (bridge to candidacy. To deny a patient a BTT VAD based on the above criteria is less than optimal care and takes a step back in the current practice of advanced heart failure and available therapies. In addition, the ongoing advances in VAD technology would be come unavailable to a large percentage of patients. (30% or more according to INTERMACS)
To insist on a hard line between BTT and DT is in direct opposition to more current thinking and published data. Every year, patients implanted as either BTT or DT profile are increasing in number, living longer and delaying decision to proceed with heart transplant. Furthermore, CMS and INTERMACS will be challenged when attempting to review data as there will be a large "crossover" or change in profile from profile at implant to intended use.

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August 30, 2013

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Comments on Proposed Decision Memorandum for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)

Dear Dr. Jacques:

The International Society for Heart and Lung Transplantation (ISHLT, or the Society) is pleased to submit these comments on the Proposed Decision Memorandum for Ventricular Assist Devices (VAD) for Bridge-to-Transplant (BTT) and Destination Therapy (DT), which proposes changes to the current National Coverage Determination (NCD) for Artificial Hearts and Related Devices. Our comments focus primarily on the proposal to clearly identify that patients must be active on the waitlist of the Organ Procurement and Transplantation Network under the existing BTT requirement. We urge the Centers for Medicare and Medicaid Services (CMS, or the Agency) to consider our recommendation that bridge-to-candidacy (BTC) patients receive coverage under the BTT indication.

The ISHLT is a multidisciplinary organization of professionals dedicated to improving the care of patients with advanced heart or lung disease. Through research, education, and advocacy, the Society seeks to promote transplantation, mechanical support, and innovative therapies for these patients. ISHLT has over 2,500 members from over 45 countries, representing over 14 different disciplines involved in the management and treatment of end-stage heart and lung disease. This multinational and multidisciplinary mix is one of the biggest strengths of the Society, bringing greater breadth and depth to our educational offerings. Furthermore, it provides an exceptional environment for networking and exchanging information on an informal basis.

ISHLT’s comments are discussed in detail below. Our comments address the majority of the proposed changes to the NCD, dealing with each provision in the order in which it appears in the proposed decision memorandum.

1. VADs for BTT

2. Clearly Identifying that Patients Must be Active on Waitlist of Organ Procurement and Transplantation Network

“For the existing BTT requirement that a patient must be approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, CMS proposes to clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network.”

The first question of interest for this National Coverage Analysis (NCA) was: “Is the evidence adequate to conclude that maintaining the current patient selection criteria for VAD implantation will provide improved health outcomes for Medicare beneficiaries?” In clinical practice, transplant centers currently implant patients with mechanical circulatory support (MCS) who are not listed at the time of implant, but who they ultimately intend to transplant, due to the presence of reversible factors which preclude their listing. These patients are known as BTC or bridge-to-decision (BTD). Under CMS’ proposed policy, however, these patients would not be covered as BTT, because they were not listed at the time of implant, even if the intent is to transplant. In contrast, most private insurers currently allow for this distinction and recognize the intent of the center, rather than the status of the patient listing at the time of implant.

If CMS’ proposal became final, the Society is concerned it would not provide for improved outcomes for Medicare beneficiaries. Instead, it would serve to limit beneficiaries’ access to this technology. Under such a rule, patients eligible to be implanted as BTC due to reversible causes (such as pulmonary hypertension) would instead have to be formally presented to a center’s selection committee and formally declined for transplant. This would, in turn, trigger a formal notification of transplant ineligibility to the patient by the center. Patients would then have to meet DT criteria in order to be implanted, even though they might otherwise meet criteria to be implanted as BTT. Clearly this process is quite vexing for patients and their families, needlessly adding confusion to a process that is already complex and unfamiliar to them.

Our specific responses to CMS discussion points raised in the proposed decision memorandum relating to this proposal are as follows:

Labeling Issues: The proposed decision memorandum states that, “[c]urrently, devices are only covered if they have received approval from the FDA for BTT” and “are used according to the FDA-approved labeling instructions.” Elsewhere it indicates that the definitions of BTT and DT were “derived from pivotal VAD trials and FDA-approved device labeling.” This definition of BTT, however, differs from the language used by the FDA in their labeling. For example, the labeling for the HeartMateII as BTT (PMA P060040) states: “The HeartMateII LVAS is intended for use as a bridge to transplant in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure.”¹ Additionally, the labeling for the HeartWare VAS as BTT (PMA P100047) states: “The HeartWare Ventricular Assist System (HeartWare VAS) is indicated for use as a bridge to transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.”² Neither of these labels requires the patient to be actively listed for transplantation, but rather require the technology to be used as a means to support those with end-stage heart failure who are candidates for transplantation. The Society would submit that those who are implanted as BTC are, in fact, being bridged as a means to ultimately list them for transplantation.

Fluidity of Eligibility and Ineligibility: We also find it inconsistent that transplant listing has become the sine qua non of BTT, because being listed for transplant is a fluid criterion both within and between institutions. Furthermore, the proposed decision memorandum states that DT should be for the transplant ineligible. As with transplant eligibility, transplant ineligibility is also a fungible concept without quantifiable metrics. Is a patient who cannot be listed prior to implant due to a social issue that will be resolved shortly or a potentially quickly reversible comorbidity truly transplant ineligible? If not, then how long would a center reasonably have to wait before considering a patient to be ineligible - one day, one month, one year, or longer – and with what degree of certainty?

Use of Multidisciplinary Team: The proposed decision memorandum explicitly acknowledges that “complex medical decisions about candidacy for transplantation or MCS are best made by an experienced multidisciplinary team” to make the case for the requirement that approved centers have a multidisciplinary VAD team. The Society concurs with this approach, but we believe this philosophy should naturally extend to the centers as they make these same complex decisions when determining the timing of listing for those who receive MCS.

Clinical Judgment: In the section entitled Patient Selection Criteria, CMS notes that there are patient characteristics and risk factors that were not represented in the pivotal clinical trials which led to a device’s approval. As such, many patients who received a device after approval would have been excluded from clinical trials. However, when considering such patients, CMS “will defer to the judgment of experienced clinicians.” Clearly, CMS recognizes that in the transition of an approved device to clinical use many patients in whom the device is used would not have been part of the clinical trials. Yet, these same comorbidities, which are left to the discretion of the physician with respect to candidacy for MCS, are often the same comorbidities which determine transplant eligibility and make patients BTC. It is not consistent to allow the latitude for clinical judgment for comorbidities for device implantation and determining transplant eligibility, but then fail to recognize the inevitable consequence of such decisions when it applies to indications for MCS, namely that some patients supported with MCS with the intent to transplant will not be listed at the time of implantation.

Clinical Experience with BTC Patients: The proposed decision memorandum notes that “pivotal trials for FDA approval of VADs have focused separately on BTT and DT without mention of BTC” and they have not “identified any trials that have enrolled BTC patients and no devices carry a labeled indication for BTC.” While there has not been a trial of BTC patients, there has been an extensive and published clinical experience with such patients. There are currently almost 2,500 patients implanted with the designation of BTC in INTERMACS who have been followed for up to six years. This is a substantially larger number of patients with longer follow-up than the total number of patients who were initially part of the approval trials for current devices.

The largest study to date dedicated to this group of patients uses data from INTERMACS on 2,816 patients with continuous flow LVADS.³ During the time period of this study, 38% of patients were implanted as BTT, 42% as BTC, and 20% as DT. The three groups had few significant differences in their preimplant degree of cardiac dysfunction, hemodynamics, and heart failure therapy, substantiating the notion that all patients, regardless of indication, are being supported for end-stage systolic heart failure. Nonetheless, the groups did differ in their prevalence of comorbidities, with BTC and DT having higher percentages of comorbidities than the BTT patients. However, many of the comorbidities in the BTC category are potentially reversible with MCS. Overall, the two-year survival rate of BTC patients (70.1%) was between that of BTT (77.7%) and DT (60.7%), and those who were BTC but considered likely to be transplanted had a two-year survival of 73.7%, comparable to those implanted as BTT.

There was also considerable change in the treatment intent over time. Of those who were implanted as DT with CF devices and still on support at one year, nearly 20% were being considered for transplant or were listed for transplant. For those implanted as BTT who remained on support at one year, 16% were no longer actively listed for transplant and 6% were considered DT. Moreover, by two years 21% of those still on support who had been implanted as BTT were changed to a strategy of DT. Of those who were implanted as BTC and still supported at 1 year, 36% were listed for transplant and 17% were DT.

Furthermore, while the proposed decision memorandum states that BTC patients are not recognized as an approved indication, the data CMS presented for device effectiveness as BTT cites studies which include BTC patients. The HeartMateII post-approval study used patients from the INTERMACS registry⁴ and includes those who were BTT and BTC-likely. A study of 486 patients from the HeartMateII pivotal trial and 1,496 implanted after approval and enrolled in INTERMACS, again included patients that were BTT and BTC-likely.⁵ Hsich et al. examined sex differences of 401 women and 1,525 men in INTERMACS from June 23, 2006 to March 31, 2010 that were BTT, BTC, and DT, of which BTC made up 45% of the cohort.⁶ One of the studies cited for device durability included all continuous flow pumps, including those implanted as BTC and not just BTT and DT.⁷

The various INTERMACS reports cited in the NCA looked at all continuous flow devices and included patients who were BTT, BTC, and DT (36% of which were BTC), and of those >=65 years old, 18% were BTC.^8-10 If BTC patients are not a recognized indication and cannot be covered under the BTT indication, then we are uncertain why they were included as evidence of effectiveness for MCS in general and BTT in particular.

In the recently-published “Guidelines for the Management of Heart Failure” by the American Heart Association there is a Class IIa recommendation (with Level of Evidence: B) that “nondurable MCS, including the use of percutaneous and extracorporeal ventricular assist devices, is reasonable as a ‘bridge to recovery’ or ‘bridge to decision for carefully selected patients’ with markedly decompensated hemodynamics with systolic dysfunction.” ¹¹ Many such patients do not recover ventricular function with temporary devices and are transitioned to permanent mechanical support, but are often not able to be listed at the time of implant.

The Society would like to restate its recommendation that BTC patients be covered by the BTT indication.

CMS proposes to remove the existing requirement that a “‘Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically possible. Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available.’” The Society is supportive of this change.

2. VADs for DT

Regarding VADs as DT, CMS proposes that there is insufficient evidence to support changes to the Agency’s current patient selection criteria for coverage of a VAD as DT. Given the lack of recognition of BTC patients by the NCA and in light of the facts presented above, we would argue that CMS is de facto changing the current selection criteria for DT. By not including BTC patients in the definition of BTT, particularly those likely to be transplanted (i.e., those with pulmonary hypertension or who needed to complete a period of tobacco abstinence), BTC patients could only be implanted as DT. However, the DT trials did not typically include such patients; rather they typically included patients thought of as being permanently ineligible for transplant. As the proposed decision memorandum itself states, “devices are only covered as DT for those with chronic end-stage heart failure who are not candidates for heart transplant.” BTC patients are implanted as BTC, rather than DT, precisely because they are thought to be potential candidates for transplantation. Thus, there is no trial evidence supporting the inclusion of such patients in the DT definition.

A sizable proportion of BTC patients will eventually be listed for transplant; hence it seems reasonable to define their intent as a BTT. It may be argued that some BTC patients are never listed and are changed to a strategy of DT, but we would counter that even patients listed at implant may never actually be transplanted due to complications accrued while on support or even by patient choice. The fluidity of strategies over time even calls into question the utility of characterizing patients as BTT and DT at implant. If such distinctions are to be made, it seems reasonable to make the distinction at implant; namely, is it the implanting center’s ultimate intention to transplant the patient or not, regardless of the status of listing at the time of implant.

CMS states that “[t]he evidence is sufficient to conclude that VADs implanted in facilities that meet certain criteria improve health outcomes for Medicare beneficiaries. CMS indicates that facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities for a period of one year following the posting of the final decision of the memo. At the conclusion of this transition period, these facilities must be in compliance with specified criteria as determined by the credentialing organization.”

We would submit that approved programs already meet these requirements. Thus, due to the significant time, effort, and cost to prepare for such reviews by the programs as well as current time constraints, we would urge that as of the date of the final decision, programs already DT-certified should be required to renew their approval two years after their last approval date, rather than the suggested one year. For such programs, the Society would be supportive of a requirement to document that they meet the facility criteria within one year of the final decision, but without requiring a formal review.

In the proposed decision memorandum, CMS states that “[b]eneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience. The team is required to embody collaboration and dedication across medical specialties to offer optimal patient-centered care.” The proposed decision memorandum indicates that, “[c]ollectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent.” CMS also lists a set of proposed criteria for the makeup and experience of this team.

The Society is supportive of these criteria and they are reflected in the Society’s MCS Guidelines.¹² However, we feel that there is substantially less evidence supporting these recommendations than those supporting the inclusion of those implanted BTC as BTT. For these program criteria, CMS is deferring to the consensus of the MCS community’s opinion. The cited evidence for these facility criteria in question 2 of the NCA are comprised mainly of brief opinions from manuscripts that did not specifically address these criteria. The only manuscript with data that was focused on facility criteria only had 40 patients before and 36 patients after the introduction of a new management protocol. ¹³ Moreover, the authors were not able to control for the differences that may have resulted from changes in technology or site experience over the course of the study. The Society presents this data not to call these recommendations into question, but rather to support the use of community consensus and robust registry data, such as INTERMACS, in the absence of a formal trial to shape the scope of coverage decisions.

2. Tracking Patient Outcomes

CMS indicates that, “[f]acilities must track patient outcomes including survival, adverse events (e.g., bleeding, infection, and device malfunction), functional status, and quality of life in a way that allows comparison with other institutions and facilitates internal quality monitoring and improvement.” Consistent with our opinion about INTERMACS (found below), we believe that INTERMACS provides the ability of programs to track survival, major adverse events, functional status and quality of life and, more importantly, establishes a national standard of the rates of these events to which a center’s experience may be compared. INTERMACS also provides standard definitions for adverse events so that complication rates can truly be compared across centers and device trials. The periodic INTERMACS reports allow for programmatic quality monitoring and metrics.

3. Facility Credentialing

CMS proposes that a “facility must be credentialed by an organization approved by CMS.” The Society is supportive of this decision.

3. Removing Requirements Relating to Informed Consent

The proposed decision memorandum contemplates removing the separate requirement that hospitals have in place staff and procedures for appropriate informed consent as this requirement is encompassed in the definition of the multidisciplinary team. The Society is supportive of this decision.

4. Eliminating Requirement for INTERMACS Participation

The proposed decision states that the evidence is sufficient to conclude that, “[c]ontinuing required participation in [INTERMACS] will not adequately address the outstanding evidentiary questions for VADs; therefore, INTERMACS participation is no longer required for VADs to be determined reasonable and necessary and CMS proposes to remove this requirement.

Why CMS would choose to remove this requirement is unclear. As the proposed decision memorandum notes, INTERMACS was “established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Center for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists, and industry representatives.” While CMS may feel INTERMACS cannot address the issues contained in this NCA, the technology and its use will not remain static, and there is an ongoing need to follow outcomes, particularly in light of requirement in (2)(b)(ii) of the proposed decision memorandum. INTERMACS serves both parts of this requirement for centers, as it can “track patient outcomes . . .” and “facilitate internal quality monitoring and improvement.” Currently INTERMACS has data on over 10,000 patients, including their outcomes, major adverse events (all of which now have common definitions accepted by clinicians, industry, and regulatory agencies), and quality of life metrics. Given the near universal representation of domestic MCS centers, INTERMACS allows the establishment of national outcome and quality metrics that “allows comparison with other institutions” as required in this NCA. Otherwise it is unclear to the Society how such standards and outcomes could be assessed if such data was contained in numerous data sets with differing standards with no ability to provide consensus.

Furthermore, the number of patients in INTERMACS is an order of magnitude greater than in all the approval trials of both BTT and DT that are cited in the NCA, with longer follow-up and data on outcomes and event rates that are reflective of clinical use rather than their use with more restrictive criteria in clinical trials. For the trial data cited in this NCA, the HeartMateII BTT trial enrolled 133 patients and outcomes were assessed at 6 months. ¹⁴ These patients, plus an additional 148, were reported in a separate study with 18 months outcomes.¹⁵ Similarly, the HeartWare BTT approval trial had 140 patients with six month outcomes.¹⁶ Given the limited number of patients in BTT trials and their limited follow-up, the Society is unclear why INTERMACS would not continue to inform CMS. The MCS community looks to INTERMACS to assess these metrics and regulatory agencies have adopted INTERMACS outcomes for use as a control group in the HeartWare BTT trial.¹⁶ Additionally, in the Internal Technology Assessment section, it is noted that “CMS examined the evidence regarding the impact of VADs on mortality, morbidity, QOL and functional status with end-stage congestive heart failure.” Much of the data cited in this section by CMS came from studies which used INTERMACS data (most exclusively so). These include:

• Starling et al ⁴
• John et al ⁵
• Hsich et al ⁶
• Kirklin et al ⁸
• IM QSR 2012 4th quarter ¹⁷
• IM CMS report, 2013 ¹⁸
• IM CMS Q4, 2012 ¹⁹
• Kirklin et al ²⁰

Likewise, the proposed decision memorandum also used INTERMACS data to address question two of the NCA: “Is the evidence adequate to conclude that maintaining the current facility criteria for VAD implantation will provide improved health outcomes for Medicare beneficiaries?” These include:

• IM QSR 2012 4th quarter ¹⁷
• IM CMS report, 2013 ¹⁸
• IM CMS report, 2012 ¹⁹
• Holman et al ⁷

Clearly, outcomes in INTERMACS have become the standard to which new devices must be compared. Otherwise, it is unclear what the standard would be with the introduction of new technology. Lastly, how devices would be assessed in clinical use outside of the more limited trial inclusion criteria remains unanswered.

The proposed decision memorandum states that the original decision to require INTERMACS was to: 1) provide information on long-term outcomes; 2) examine outcomes outside of trial constraints; and, 3) assess programmatic quality. It is noted that CMS feels it has sufficient data to answer questions one and two, but the Society is concerned that such questions would be unanswerable with the introduction of new devices. For instance, to what long-term non-trial data will these pumps be compared?

INTERMACS also allows the ability to detect, quantify, and monitor novel adverse events which were not anticipated with initial trial design, such as gastrointestinal bleeding and aortic insufficiency. As a large national database, INTERMACS would be powered to identify novel risk factors, disseminate the findings and then help assess the adoption and impact of these findings. Such factors will be critical to improve outcomes with current and future devices, as well as improve their cost-effectiveness.

Finally, the proposed decision memoradum notes that there is only “progress” noted on the third goal. The Society would submit that INTERMACS provides the standards by which programmatic quality may be assessed.

5. Designating Credentialing Organizations

CMS is also proposing to “allow organizations that have credentialing programs specific to VADs to apply to CMS to be designated as a credentialing organization for VAD facilities for DT. CMS states that these programs must ensure that credentialed facilities meet the criteria outlined in the NCD, and may include additional requirements necessary to operationalize these criteria or administer the credentialing program. Beyond these statements, any additional substantive credentialing standards not identified in the final NCD are not required for Medicare coverage.”

The Society is generally supportive of this proposal, but the details of the process for such credentialing are not yet established. The Society looks forward to the opportunity to review these proposals in the future.

CONCLUSION

The Society appreciates the opportunity to respond to CMS’ proposed decision memorandum as part of the NCA to amend the NCD on Artificial Hearts and Related Devices. We would like to thank you for your consideration of our thoughts on this critical subject.

Sincerely,

Jeffrey Teuteberg, MD
Past-Chair, MCS Council
On behalf of the International Society for Heart and Lung Transplantation

Citations
1. FDA, 2008. FDA Summary of Safety and Effectiveness. PMA number P060040.
2. FDA, 2012. FDA Summary of Safety and Effectiveness. PMA number P100047.
3. Teuteberg, J., Stewart G., Jessup M., Kormos R., 2013. Implant strategies change over time and impact outcomes: Insights from the Interagency Registry for Mechanically Assisted Support. J Am Coll Cardiol HF, in press.
4. Starling, R., Naka, Y., Boyle, A. & Gonzalez-Stawinski, G., 2011. Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS Registry. J Am Coll Cardiol, 57(19), pp. 1890-8.
5. John, R., Naka, Y. & Smedira, N., 2011. Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg, 92(4), pp. 1406-13.
6. Hsich, E., Naftel, D. & Myers, S., 2012. Should women receive left ventricular assist device support?: findings from INTERMACS. Circ Heart Fail, 5(2), pp. 234-40.
7. Holman, W., Naftel, D., Eckert, C. & Kormos, R., 2013. Durability of left ventricular assist devices: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2006-2011. J Thorac Cardiovasc Surg, S0022-5223(13), pp. 00168-2.
8. Kirklin, J., Naftel, D. & Kormos, R., 2013. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant, 32(2), pp. 141-56.
9. Kirklin, J., Naftel, D., Kormos, R. & Stevenson, L., 2011. Third INTERMACS Annual Report: The evolution of destination therapy in the United States. J Heart Lung Transplant, 30(2), pp. 115-23.
10. Kirklin, J., Naftel, D. & LW, S., 2008. INTERMACS Database for Durable Devices for Circulatory Support: First Annual Report. J Heart Lung Transplant, 27(10), pp. 1065-72.
11. Peura J., Colvin-Adams M., Francis G., Grady KL., 2012. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: A scientific statement from the American Heart Association. Circulation, 126, pp.2648-2667.
12. Feldman D., Pamboukian S., Teuteberg J., 2013. The 2013 International Society of Heart and Lung Transplantation guidelines for mechanical circulatory support: Executive summary. J Hear Lung Transplant, 32(2), pp. 157-87.
13. Pamboukian, S., Tallaj, J. & Brown, R., 2011. Improvement in 2-year survival for ventricular assist device patients after implementation of an intensive surveillance protocol. J Heart Lung Transplant, 30(8), pp. 879-87.
14. Miller, L., Pagani, F. & Russell, S., 2007. Use of a continuous-flow device in patients awaiting heart transplantation.. N Engl J Med, 357(9), pp. 885-96.
15. Pagani, F., Miller, L., Russell, S. & Aaronson, K., 2009. Extended mechanical circulatory support with a continous-flow rotary left ventricular assist device. J Am Coll Cardiol, 54(4), pp. 312-21.
16. Aaronson, K. et al., 2012. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation, 125(25), pp. 3191-200.
17. INTERMACS CMS Q4, 2012. INTERMACS Quarterly Statistical Report Centers for Medicare & Medicaid Services 2012 4th Quarter. [Online] Available at: http:/www.uab.edu/medicine/intermacs/images/CMS/CMS_Report_2012_Q4.pdf
18. INTERMACS CMS Report, 2013. Prepared April 21, 2013. [Online] Available at: http://www.uab.edu/medicine/intermacs/component/content/article/152-uncategorised/161-intermacs-responses
19. INTERMACS Q4, 2012. INTERMACS Quarterly Statistical Report 2012 4th Quarter. [Online] Available at: http://www.uab.edu/intermacs/images/Federal_Quarterly_Report/INTERMACS_Federal_Partners_Quarterly_Report_03_2012_website_all.pdf [Accessed 7 May 2013].
20. Kirklin, J., Naftel, D. & Pagani, F., 2012. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation?. J Thorac Cardiovasc Surg, 144(3), pp. 584-603.

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August 30, 2013

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

Re: CAG-00432R

Dear Sir/Madam:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for ventricular assist devices (VADs) for bridge-to-transplant and destination therapy.

We applaud CMS for carefully evaluating the issue of VAD therapy in patients with advanced heart failure. This group of patients already represents a major healthcare concern for society and will become even more important with the aging of the American population. AHA however, has several concerns with the proposed coverage policy, which we would like to take the opportunity and raise to your attention. Specifically, we are concerned that the revised policy:

1. Fails to acknowledge and provide coverage for a large group of patients, the bridge-to-decision group, who clinically are in need of this therapy but may not clearly fit one of the other two designated indications. This issue also relates to the requirement that bridge-to-transplant patients be active on the waitlist maintained by the Organ Procurement and Transplantation Network.


2. Eliminates the requirement that facilities participate in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).


3. Does not address board certification as a qualification for the cardiologist member of the multidisciplinary team required for destination therapy.

We expand upon these concerns below.

Coverage for Bridge-to-Decision Patients
AHA is concerned that the proposed coverage policy does not include "bridge-to-decision" as a covered indication. As stated in our previous comments to the Agency, clinically, over one-third of all patients who receive VAD therapy fall into the category of bridge-to-decision where providers are not certain if the patient will eventually be a transplant candidate or not, or if the VAD will remain implanted for the remainder of the patient's life. In certain circumstances, a patient's heart function may improve sufficiently to even warrant removal of the device. To provide coverage for these patients, we recommended that CMS remove the requirement that destination therapy patients cannot be candidates for a heart transplant, or revise the covered indications to distinguish between a VAD as bridge-to-transplant for patients already on the transplant waiting list and a VAD as "therapy for advanced heart failure" in all other patients, without arbitrary designation of likelihood for transplantation in the future. We understand that other groups have made similar recommendations to the Agency.

CMS did not propose any changes to the covered indications or the patient selection criteria, instead choosing to continue to model Medicare coverage on the device trials used to secure FDA approval of these devices. Because those trials focused on bridge-to-transplant and destination therapy separately and did not enroll what CMS refers to as bridge-to-candidacy patients, the Agency felt it did not have sufficient evidence to justify expansion. While we understand the Agency's reasoning, we disagree on clinical grounds that it is necessary for Medicare to follow the paradigm set by the FDA. Doing so simply perpetuates arbitrary distinctions and ignores how these devices are used in the actual clinical setting. CMS itself has acknowledged that VADs are increasingly being used for the bridge-to-decision indication (36% of all VADs and 18% of VADs in patients age 65 and older). Importantly, the most recent clinical practice guidelines for heart failure give VADs used for bridge-to-decision or bridge-to-recovery a class IIa recommendation,¹ calling VAD implantation in these patients "reasonable". This is same terminology CMS uses to determine if a procedure should be covered by Medicare.

Limiting Medicare coverage to bridge-to-transplant and destination therapy strictly does a serious disservice to patients with predictably negative impact. For example, when urgent therapy is required, providers may feel compelled to prematurely classify patients as bridge-to-transplant or destination therapy even if it is not clear at that point and it may not be in the best interest of the patient; however these decisions usually cannot wait for the duration to make those judgments due to the severity of illness. An unintended and deleterious result would be an artificial inflation of the number of patients being listed for transplant and sub-optimal utilization of the limited donor supply. On the contrary, requiring other patients to be classified prematurely as destination therapy to obtain access to lifesaving support may result in the patient not being closely followed by transplant centers to evaluate the possibility of future transplantation or recovery, as their clinical course evolves.

These issues are also related to the Agency's proposal to require that bridge-to-transplant patients be active on the waitlist maintained by the Organ Procurement and Transplantation Network (OPTN). This change may compound the problems inherent in a system that requires providers to pick from two narrowly-defined coverage indications, especially when the decision must be made quickly to address an urgent therapy need. For example, a patient may be a good transplant candidate, but due to the patient's worsening health condition, the provider must implant a VAD before the transplant evaluation and listing on OPTN can be completed, forcing the provider to inaccurately classify the patient as destination therapy. Or, a provider may feel compelled to prematurely list a patient on the OPTN to meet the requirements for bridge-to-transplant, resulting in poor stewardship of the limited donor supply. Under current practice, almost 50% more patients are listed each year than actually undergo transplantation; mandating further additions would result inevitably in further bloating of the transplant list and lengthening wait times. Premature listing on the OPTN may also inflate the already unwieldy heart transplant list with new VAD recipients who are in varying stages of post-operative recovery and complications going through multiple status changes.

Thus, we urge CMS to revise the covered indications for VADs. The revised indications should provide coverage for bridge-to-decision or bridge-to-candidacy patients, as well as patients for whom a VAD may potentially help reverse the advanced heart failure state. In addition, the policy should recognize that patients may transition from one category to another over time as the disease progresses or improves or the comorbid conditions change. (See Attachment A). We further recommend that CMS consider revising the bridge-to-transplant language to include coverage for patients who are approved for transplant, as well as those who are under evaluation for transplantation, and remove the required active listing on the OPTN.

INTERMACS Participation
According to the proposed decision memo, CMS believes that participation in INTERMACS should no longer be required for Medicare coverage. We humbly disagree with this assertion. We recognize the Agency's rationale . that the INTERMACS data has already validated the original indications and is therefore no longer necessary for CMS reimbursement. However, we are still in the early stages of the evolution of this field, for which coordinated and timely data collection and analysis remains vital to ensure responsible use of this expensive technology. Required reporting in standardized format is essential to alert and inform both quality practice and reimbursement regarding patient selection and longer-term outcomes, changing rates of anticipated and new adverse events, and the impact of newer devices. We are seriously concerned that eliminating this mandate will discourage facilities from participating in INTERMACS for any reason, and we believe there are multiple benefits that are accrued by participating in this national registry.

INTERMACS is an extremely valuable source of data that has been used to help identify the appropriate patient population for VADs, risk factors that determine outcomes of patients undergoing VAD implantation, and when in the course of disease a VAD should or should not be implanted. INTERMACS has also been instrumental in facilitating consensus on developing definitions of VADrelated outcomes and adverse events. INTERMACS is poised to help answer important questions about efficacy as they arise. VAD technology and process of care (both pre and post VAD) are continuously evolving and therefore many known data become obsolete relatively quickly. We need ongoing data collection to continually optimize outcomes related to this therapy. We believe it would be a mistake to eliminate mandatory participation in this registry just as we are at the critical juncture of having enough patients to start to fill-in remaining evidence gaps, such as for outcomes beyond the 1-2 years of trials for pre-market and post-market approval. There is widespread agreement that we do not want to return to the days when the only level of evidence was that selected by individual device manufacturers and individual centers. It should be emphasized also that the type of standardized national outcome data stratified by patient characteristics in INTERMACS is exactly what is needed to facilitate the shared decision-making process, as we move towards better patient-centered care for advanced heart failure.

We are also concerned that removing the incentive for participating in INTERMACS and instead allowing facilities to self-track patient outcomes, adverse events, functional status, and quality of life, would result in non-standardized and un-validated approaches, and the inevitable apple-to-orange comparison of non-comparable data. A third party reporting and monitoring system that allows for the systematic provision and analysis of outcome data in a uniform manner across all facilities and all devices is imperative. Furthermore, we regard this as the most effective way to help individual centers understand and refine their own practices, by comparison of their own experience to national benchmarks for 30-day, 1, 2, and 3 year survival, adverse event rates, compliance with quality of life and functional capacity assessment and patient-rated satisfaction with VAD therapy.

Please see Attachment B for tables demonstrating the type of data that INTERMACS provides to hospitals on a regular basis for use in their own quality improvement initiatives.

Requiring facilities to participate in INTERMACS is the only way to ensure that we will continue to have access to the valuable data that is needed to care for these patients, and centers will have access to the data needed for ongoing quality improvement guided by national standards. We therefore urge CMS to maintain the requirement that VAD facilities participate in INTERMACS as part of the coverage policy.

Multidisciplinary Team Requirements
CMS has proposed that patients who receive VADs for destination therapy must be managed by a multidisciplinary team that includes, among others:

The requirement does not, however, explain how the cardiologist's training and clinical competence will be determined.

AHA strongly recommends that the cardiologist training requirement specifically be American Board of Internal Medicine (ABIM) certification in the secondary subspecialty of Advanced Heart Failure and Transplant. Cardiologists who seek this certification are specially trained in heart failure, transplant, and VAD management. Requiring ABIM certification would provide better assurance that the cardiologist is highly trained and can appropriately care for a VAD patient. We therefore recommend that CMS add ABIM certification in Advanced Heart Failure and Transplant to the definition of a qualified heart failure cardiologist.

Conclusion
In closing, we appreciate the Agency's efforts to continue to refine the coverage policy for VADs. VADs are an important therapy option for patients with advanced heart failure, and when used in the appropriate patient population, can lead to significant improvement in health outcomes. We are however concerned that several of the changes proposed by CMS may limit patient access to these devices, undermine the collection of data necessary to enhance quality and maintain progress, or have other unintentional adverse consequences.

To ensure that this therapy option is available to patients who would benefit from a VAD, CMS should revise the covered indications to include bridge-to-decision or bridge-to-candidacy patients by removing the current restriction that destination therapy patients cannot be candidates for a heart transplant. Alternatively, as discussed in detail at the MEDCAC meeting in November 2012, CMS could update the destination therapy category to better reflect contemporary utilization of VADs as life-saving therapy for end-stage heart failure in patients not currently on the active list for cardiac transplantation. Further, CMS should remove the impractical restrictive requirement that bridge-totransplant patients be active on the OPTN waitlist.

To make certain that valuable quality and outcomes data remain available, CMS should keep the INTERMACS requirement. These data will help providers identify patients who are most likely to have a positive outcome, as well as compare their facility's performance with others.

Finally, to ensure that VAD patients are cared for by cardiologists with the appropriate training and clinical competence, CMS should require ABIM certification in Advanced Heart Failure and Transplant.

Thank you for consideration of our comments. If you have any questions or require any additional information, please contact AHA staff Susan Bishop at (202) 785-7908 or susan.k.bishop@heart.org.

Sincerely,

Mariell Jessup, MD, FAHA
President
American Heart Association

Attachments

1 Yancy CW, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure.Circulation.2013; 128.

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Patients receive ventricular assist devices within varying degrees of stage III-IV heart failure. Some patients are in cardiogenic shock when he/she receives the VAD, while some patients are able to stay out of the hospital and schedule the implant as an elective procedure. Calling a patient bridge to transplant or destination therapy at the time of implant does not accurately reflect the patient's health status and ability to move forward with a transplant in six months to one year later.

It is not possible to perform a transplant evaluation on a patient who enters the hospital gravely ill and requires life support. After VAD implant, the patient may be in a completely different health state a few weeks to a few months and sometimes a year later. The point of placing LVADs is to bridge to transplant or simply to prolong life. The goal of the bridge to transplant is to have the patient stronger and healthier when the transplant surgery occurs vs when the VAD was implanted. Patients who survive and thrive after VAD, have better outcomes after transplant. However at time of VAD surgery, especially if the VAD is placed emergently; the ability of the team to perform the transplant evaluation is compromised. Ultimately, there are many patients who are called DT in the beginning and then are transplanted later. Requiring BTT or DT labels prior to an implant is an inaccurate, narrow view of the reality of patients living multiple years on VADs and challenging the initial label given.

Each center should have the ability to implant the VAD with the indication that the advanced heart failure team dictates and then have the option to decide with the patient if the patient qualifies for a transplant after a thorough transplant evaluation can be completed.

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The proposed CMS BTT criteria are not applicable to the reality of clinical practice that providers are faced with today. At the time of the VAD implant and transplant evaluation the patient is not always a clear candidate to list on the OPTN waitlist and may result in inappropriate listing conditions to meet the proposed policy changes. Many patients who require a VAD may have modifiable or relative risk factors that keep them from being an immediate transplant candidate such as psychosocial factors, treatable medical conditions, or severity of heart failure at the time of presentation. These issues commonly resolve after a sufficient time of VAD therapy such as 3-6 months post implant. The patient may then become a suitable heart transplant candidate requiring deferred evaluation. Due to the proposed listing requirement, the patient would have to be classified as DT, for which Medicare has certain coverage criteria that the patient may not fit any more clearly than the BTT criteria. Removal of the listing status gives the opportunity for CMS to align with current clinical practices. Further, this would avoid a wrong classification of the patient as the situation changes.

Additionally, the CMS requirement that a patient must be approved and actively listed as a candidate for heart transplant may delay therapy and access to those patients who need immediate VAD support. The time it takes to fully work up and list a patient for transplantation is not short. VAD therapy may be needed prior to a clear distinction between whether the patient is more appropriate for BTT or DT. Ultimately, providers can only allocate these patients into the bridge to determination (BTD) or bridge to candidacy (BTC) buckets. Setting a long-term treatment strategy such as BTT or DT while an advance heart failure patient is decompensating creates unnecessary risk to the patient and can delay care. Furthermore, a premature assignment to long-term treatment strategies (BTT vs. DT) may ultimately be incorrenct and would add increased confusion to the patient and family during times of critical illness.

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Thoratec Corporation would like to thank the Center for Medicare and Medicaid Services (CMS) for addressing the three issues outlined in our earlier comment regarding the February 7, 2013 National Coverage Determination announcement in the Proposed National Coverage Determination.

• Healthcare team and hospital standards that optimize patient outcomes.
• Evidence to support the current requirement for certification of hospitals implanting VADs for Destination Therapy.
• The clinical evidence supporting identification of patients expected to experience improved health outcomes with VAD placement.

Studies such as Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients ROADMAP with the objective to evaluate and compare the effectiveness of Continuous flow LVAD support versus optimal medical management (OMM) in ambulatory non-inotrope dependent NYHA Class IIIB / IV patients and National Heart Lung Blood Institute study Randomized Evaluation of LVAD Intervention Before Inotropic Therapy RESIST trial set-up to evaluate and compare the effectiveness of LVAD support versus optimal medical management (OMM) in patients with advanced HF (class III) with illness not severe enough to qualify for transplant or permanent LVAD therapy based on current guidelines have been initiated to further define the population as outlined by CMS in the proposed coverage decision to identify patients who most benefit from LVAD therapy.

The Medical Arm of Mechanical Circulatory Support Study MEDAMACS further identifies a population of ambulatory patients (class IIIB/IV) followed on optimal medical therapy for whom chronic HF limits both function and survival to a range where elective implantation of LVAD devices should offer meaningful benefit.

With these studies now available for participation, it is important for investigating centers to enroll patients so data as defined by CMS can be provided to expand coverage to those who need the therapy regardless of indication. In this way, the clinical evidence supports identification of patients expected to experience improved health outcomes with VAD placement.

Registries such as INTERMACS continue to help identify areas that need additional study as well as confirm benefit and usage of existing devices. INTERMACS provide a robust data base to incorporate centers’ clinical experience and a methodology to report and publish the current state of overall VAD usage and outcomes.

It is critical as new studies are developed with manufactures and the Food and Drug Administration that CMS is involved to identify additional data required establishing specific benefit to the Medicare population. We look forward to ongoing collaboration with both organizations to insure studies are completed in a way that supports both defining device indication and benefit.

We would like to reiterate as it pertains to healthcare team and CMS recognized LVAD hospital that standards for centers to become Destination Therapy Certified be the same regardless of the accrediting body. That the uniform standards be evidence based and consistent with published guidelines. Unfortunately with the relatively new heart failure cardiologist certification program there is little information published identifying the benefits of a VAD patient being seen by a certified heart failure cardiologist versus a cardiologist experienced in the treatment of heart failure patients.

As always, we appreciate the opportunity to comment on this important coverage determination.

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August 30, 2013

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

Re: National Coverage Analysis Tracking Sheet for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)

Comment:

I would like to take this opportunity to provide a private and independent comment on the recently proposed National Coverage Decision for Left Ventricular Assist Devices (Proposed Decision Memo for Ventricular Assist Devices (LVAD) for Bridge-to-Transplant and Destination Therapy (CAG-00432R)).

 We are on the verge of a decision that has major implications for the access to lifesaving healthcare options especially in the situation of acute deterioration such as seen in acute myocardial infarction whereby, transplant candidacy vs true listing becomes a fine line.  In addition, the elimination of the requirement for centers implanting durable LVAD’s to place their implant data into a Nationally Recognized Registry such as INTERMACS places us in a very disadvantaged position regarding our ability to assess a program’s risk adjusted outcome.

I have focused my clinical, research and academic energies toward the field of mechanical circulatory support(MCS) since 1987 and have acted as an unpaid consultant to Industry, the FDA, NHLBI, and served on numerous task forces regarding MCS for a number of surgical and Medical Societies. I have served as the Past President of the International Society for Heart and Lung Transplantation (ISHLT) and in 1994 developed the Mechanical Circulatory Support Committee, for the Society of Thoracic Surgeons and then chaired the STS Workforce on End-Stage Cardiopulmonary Disease until 2008. I am a Co-PI of INTERMACS and most recently had the privilege of serving on the MEDCAC for the current proposed coverage decision.  I have no conflicts of interest.

I would like to address specific areas within the proposed coverage decision as follows:

Regarding:

1. Ventricular assist devices (VADs) for bridge to transplant (BTT)

a. For the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, we clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network.

I would encourage CMS to take into strong consideration the responses drafted in the public comments by the ISHLT, INTERMACS, HFSA and the STS regarding this issue.

Physicians will declare their patients as transplant candidates in order to allow those that would surely die an opportunity to survive.  To deny a patient a potential benefit becomes a decision that places physicians at odds with the tenants of their Hippocratic standards.

Having understood this dilemma, CMS has to understand the complexity of waiting for all the minute details of transplant eligibility to be determined and that indeed physicians in fact cannot always do this in realtime to address a life ending situation. In the earlier years of LVAD trials patients became declared a candidate for transplant based not upon some magic formula or criteria, but rather simply because they did not wish to accept patient mortality.  This practice had never been publicly recognized by CMS but it became obvious when the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) came into existence and physicians were required to state the likelihood of transplant candidacy for their patients. It has to be understood that the majority of physicians made this therapeutic intent decision in a somewhat subjective fashion, based upon their experience with such patients in their own centers and over their lives of experience. It is not that physicians do not recognize the importance of the correct delineation of a real transplant candidate; however, real life often dictates that lifesaving decisions have to be made in Medicine often without “all the information”. This is no different from the rapid and intuitive decisions that have to be made by law enforcement, first responders, the military and indeed those that run our government. So there are cases whereby tests that do not dictate transplant candidacy, but are required for the full appreciation of risk benefit in transplantation were not completed.  In the past these were regarded as non-essential and the patient was declared a 1a or 1b status and then could receive an LVAD until they recovered from their surgery during which time they remained inactive as a Status 7. Once all the information then became available they were reactivated as status 1a or 1b. These tests could include HLA typing and antibody level determination, pulmonary function studies and assessment of peripheral vascular disease. A colonoscopy to require clearance from colon cancer is often required for listing in many centers, but the question is should its absence of completion in a low risk subset of patients disqualify listing and therefore support with an LVAD?

CMS needs to understand the issue of transition of care vs the colloquial term used currently of “Bridge to Candidacy” or “Bridge to Decision”. These terms were adopted by INTERMACS to describe the transitions of instability that face physicians especially as they determine the best path of support for patients that present with an acute deterioration in their status with Congestive Heart Failure. These terms were never adopted as a “new” indication or category of reimbursable care, but rather as a way to recognize that it is better to identify patients by their real hemodynamic and clinical presentation toward the ultimate path of cardiac replacement therapy. These transitions are clearly important and need to be dealt with as not a new indication but as a pathway of acute care that provides the opportunity of reaching hemodynamic and physical stability that may eventually lead to transplantation. This is one of the major contributions made to the field by INTERMACS. It was now possible to record with a high level of granularity what actually happens to those transitional states toward transplantation.  As currently stated the coverage decision will adversely affect the care of these transition patients.

Another clear example of how limiting implantation of an LVAD to an actively listed patient produces a conflicted situation is how we approach pulmonary hypertension as a contraindication to cardiac transplantation and thus listing. The literature is replete with examples of how the application of an LVAD leads to dramatic reduction of left atrial pressure and subsequent pulmonary artery afterload with resolution of pulmonary hypertension. This could take weeks to months. Given that the criteria of absence of reversible pulmonary hypertension may not be definable at the time of LVAD placement creates a dilemma in the current NCD language.  Is this NCD suggesting that physicians choose from the following options:not list the patient, avoid placing an LVAD and accept patient death, or place the LVAD based upon good clinical judgment and risk not being reimbursed? Or, do we just list the patient with no regard to this contraindication and ignore the contraindication itself? Ultimately we are bound as physicians to do what is best for the patient. I believe that some adjustment has to be maintained in the definition of what is a transplant candidate in order to allow us to accurately provide the best outcomes with transplantation as a resource utilization issue. The proposed coverage decision, limited to only Destination Therapy and actively listed Bridge to Transplant candidates ,will create a true clinical dilemma for physicians trying to deal with the anticipated transition of presentation from acute cardiovascular compromise such as seen after an acute myocardial infarction in an otherwise previously healthy productive individual. Denial of healthcare options is not what I presume this NCD is intending. Nor, is the solution one of “listing for regulatory convenience” and then immediate readjustment to a status 7.

Regarding:

2. VADs for destination therapy (DT)

a. The evidence is insufficient to support changes to our current patient selection criteria for coverage of a VAD as DT.

 It is evident that patient selection criterion for Destination Therapy are still being refined and that defining the best candidates for this therapy are evolving. It is likely that they will be defined by a combination of cost –effectiveness, detailed risk adjustment outcomes and quality adjusted adverse event free life years which will require careful and detailed longitudinal data acquisition and analysis. As INTERMACS evolves in its utility, a joint collaboration between CMS and the Surgical and Heart Failure Societies and INTERMACS is necessary to achieve these goals.

Regarding:

2. VADs for destination therapy (DT)

2. The evidence is sufficient to conclude that VADs implanted in facilities that meet certain criteria improve health outcomes for Medicare beneficiaries. Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities for a period of one year following the posting of the final decision memorandum. At the conclusion of this transition period, these facilities must be in compliance with the following criteria as determined by the credentialing organization. As of the effective date, new facilities, must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A): Printed on 8/10/2013. Page 1 of 106
   1. Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD. The team must include, at a minimum, all of the following:
      • At least one physician with cardiothoracic surgery privileges and individual experience implanting at least 10 VADs over the course of the previous 36 months with activity in the last year.
      • At least one cardiologist trained in advanced heart failure with clinical competence in medical and device-based management including VADs, and clinical competence in the management of patients before and after heart transplant.
      • A VAD program coordinator.
      • A social worker.
      • A palliative care specialist.
      
      
   2. Facilities must track patient outcomes including survival, adverse events (e.g. bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement.
   3. Facilities must be credentialed by an organization approved by CMS.

The statements from STS, ISHLT, INTERMACS, and HFSA clearly recognize and support, as do I, the statements recognizing the multidisciplinary team that a center must develop to be an accredited LVAD program for Destination Therapy. I would also encourage CMS to support strongly the STS statements on criteria for surgeon training.  I also agree that facilities must be credentialed as suggested.

The comment in the proposed NCD that states that “Facilities must track patient outcomes including survival, adverse events (e.g. bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement.” is critical and must be read carefully.

First to accomplish this in a way that provides longitudinal data collection on the important adverse events can only be accomplished through a registry that provides the platform to do so. It is crucial that this be accomplished outside the control of Industry especially when recording device malfunction, and within the collaborative structure of the FDA. Although there are other registries that may provide a snapshot of survival within the first 30 days or for the LVAD implant hospitalization, they could not provide long-term survival data, which is critical for a therapy such as destination therapy.  Also this mandates an integrative approach to carefully risk adjust long-term survival using preoperative factors as well as the effects of adverse events. This can only be accomplished through a detailed registry such as INTERMACS. This brings us to the next comment.

Regarding:

2. VADs for destination therapy (DT)

4. The evidence is sufficient to conclude that continuing required participation in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) will not adequately address the outstanding evidentiary questions for VADs; therefore, INTERMACS participation is no longer required for VADs to be determined reasonable and necessary and CMS proposes to remove this requirement.

I understand that the CMS has evidence that is sufficient to fulfill the coverage decision for DT and BTT LVAD therapy, however I disagree that further participation in INTERMACS cannot yield important evidence of the therapy especially as it is evolving.

As far back as 1991, groups including the Institute of Medicine recommended that a detailed longitudinal database for patients receiving MCSDs be established. They stated in their report that “patients should be followed through a registry for the remainder of their lives….”(1). In 1999, we established the MCS Council and in 2001 established the first MCS registry through the ISHLT. Within that group we formed a focused group by 2004 that included 3 co-principal investigators—Dr James K. Kirklin, MD, James B. Young, MD, and myself, working in collaboration with the United Network for Organ Sharing.   The goal was to answer an RFP for a competitive contract which was eventually issued by the National Institutes of Health in collaboration with the FDA, and Center for Medicare & Medicaid Services to record and analyze patient outcomes with durable MCSDs.  The group chosen to fulfill the goals of the contract eventually became the Interagency Registry for Mechanical Assisted Circulatory Support.

One of the key questions that the MEDCAC had to answer was the following: “How confident are you that clinically significant evidentiary gaps remain regarding the use of VADs?” The answer was almost at the highest level of confidence that gaps remain to be addressed (4.85 out of 5). The Committee also expressed angst about the evidentiary questions and gaps relating to patient criteria, and operator characteristics. To that end I will restate that a nationally audited registry that records long-term data on multiple measures of outcome and risk is essential to the field and to the Healthcare system.

I believe that INTERMACS serves a critical purpose in recording the transitions that occur between the designations for Bridge to Transplantation and Destination Therapy. It also most importantly provides critical risk adjustment of these patients to help delineate in the future how to make decisions of which patients should be considered transplant listable. At present the data is just gaining discriminative ability to make them useful. INTERMACS should be utilized and have transplant listability more concretely and critically defined rather than jettisoned. If we abandon INTERMACS we risk taking our practices back to the older methodology of listing a patient for cardiac transplantation as a mechanism for facilitating the implantation of an LVAD to comply with CMS criteria for coverage as opposed to basing listing upon a logical and strategic process of reaching defined targets of improvement and likelihood of survival.  Or the alternative is to declare them DT and deny them a potential spot on the transplant list. The ultimate effect of this will be to change the SRTR metrics for a center, which will inevitably show a larger death on the waiting list statistics.

I urge CMS to consider that making INTERMACS registry participation no longer necessary based upon having the coverage decision answered, turns the regulatory and monitoring aspects of this therapy into a chaotic state whereby institutions will define transplant listability in a more independent fashion than it already does.  Also relying on individual hospitals ability to track this data does not ensure that there is a reliable way to make comparisons between centers.

Not making a national Registry such as INTERMACS a requirement if not of coverage, then at least of the credentialing process, fails to acknowledge the importance of a long-term longitudinal registry which tends to be at odds with what is the national trend for Quality Outcomes oversight. To be successful I want to emphasize the following regarding the characteristics of such a longitudinal registry:

1. Be able to capture the required information as outlined in Section 2 (ii) in a longitudinal fashion. Most important in this regards are survival, quality of life, and functional status as well as key adverse events such as bleeding, infection, neurological dysfunction, device malfunction and cardiovascular complications including recurrent heart failure.
2. Provide information for the above metrics in a way that reflects not only in-hospital metrics but also long-term metrics for the life of the patient while on the VAD.
3. Maintain an active auditing process that ensures capture of all patients on VAD’s as well as quality and completeness of data.
4. Provide at least quarterly data reports on trends in survival and patient characteristics with critical outcome metrics as mentioned above that can be utilized for regulatory purposes in the site accreditation process.
5. To serve as a reporting mechanism for determination of credentialing milestones for regulatory agencies that will deem site credentialing as a Destination Therapy VAD center.
6. Provide appropriate risk modeling that allows sites to be compared on patient population characteristics for key outcome metrics. This modeling has to be sensitive to changes in therapeutic application as well as new devices.
7. Provide a pathway for reporting to the FDA through the MDR reporting process.

If one takes the utility of a registry to the next level, which is the ability of a registry to solve a complex clinical challenge such as apparent LVAD pump malfunction, single center data, and even a minority of centers reporting on this information cannot approach the level of confidence that a registry of 10,000 patients can provide. Albeit the data required to understand this type of phenomenon and the details of such a root cause analysis will demand the highest level of partnership among individual centers with data reporting at a level yet to be acknowledged. But to simply state that the utility of INTERMACS is no longer valid, unmasks an approach that fails to engage a level of collaboration and discussion that I would submit has not yet been appropriately explored. So even if there are evidentiary gaps that CMS perceives and INTERMACS admits exist, the obvious solution is to work in harmony to bridge these gaps.

In a recent document in the Federal Register dated July 14, 2013 a National Coverage decision is proposed regarding The Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014. In this document an outline and proposal for physician driven registries has been put forth ostensibly to allow for reporting of physician outcomes that would form the basis for eventual pay-for –performance formulas. I would submit that individual physician reporting of outcomes will be less relevant for LVAD programs than the global performance measures that have been proposed by the Joint Commission, given the multidisciplinary nature of the LVAD programs making it difficult to assign outcome to an individual physician. Again most registries other than the SRTR for transplantation, fail to accommodate this. INTERMACS, however, lends itself to such global outcome measures and recognizes the important quality measures that are required to assess these programs.

In conclusion, I feel that there are a number of areas within the proposed NCD that stand out as opportunities for a more critical assessment of relevance.  I have focused on only the two major areas that trouble me: the limitation of coverage to specific indications that do not present themselves in the real world of CHF management, and the wording relative to the lack of utility of INTERMACS as a platform for important risk adjusted long term data on LVAD patient selection and outcome.

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Regarding the proposed NCD for Ventricular Assist Device, I am submitting my comments and concerns in hopes that CMS will take the time to understand the realities of caring for the end stage heart failure patient. The current policy does not take into consideration those patients who do not fit neatly into the designations set forth for coverage within the policy. By requiring that a patient either be approved and actively listed as a candidate for heart transplantation (for bridge to transplant) or be determined to not be an eligible candidate for heart transplantation (for destination therapy), Medicare coverage denies access to VADs for many patients who need them before their candidacy for a transplant can be determined. If the patient is then listed as DT, they also may not fit Medicare’s criteria for this indication. So what is a center to do if a patient does not fit the criteria for either DT or BTT? Do we want to implement policies that reflect clinical practice or do we want to have arbitrary designations that force centers to confuse patients, impact outcomes and data and put patients at risk? Because Medicare reimbursement for centers is based on these designations, centers have no other choice.

We can no longer ignore that there are a fair number of patients that are in need of a VAD prior to actively listing the patient and do not meet the DT designation criteria. I urge CMS to create comprehensive coverage for those patients at risk of death from refractory end-stage left ventricular heart failure and align with commercial policies that recognize patients that are eligible or potentially eligible for a heart transplant without being listed.

Thank you for the Opportunity
Ximena Vial PhD
VAD Bioengineer
Heart-Lung transplant
Jackson Memorial Hospital/ University of Miami

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One additional question or comment. You mention: We propose to add a statement that the NCD does not address coverage of VADs for right ventricular support, biventricular support, use in patients under the age of 18, or use in patients with complex congenital heart disease and that coverage for items and services under section 1862(a)(1)(A) in these situations will be made by local Medicare Administrative Contractors (MACs) within their respective jurisdictions.-

This appears to mean patients with these diagnosis or indications will not have coverage for MCS unless determined by local jurisdictions. Will there be a process for us to do a prior authorization for these procedures or do we just retrospectively find out if they are covered? This puts the patient and hospital in a very precarious situation.

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I would like to see a comment that VAD or TAH implant is now an approved diagnosis for cardiac rehabilitation.

If CMS no longer requires INTERMACS, yet we need to continue collecting data in a way that can be benchmarked, it is not clear to me what comprehensive location would allow for benchmarking. We currently use UHC, but I know that is only for University hospitals. As DT grows, there will be a greater percentage of hospitals that our outside this benchmarking group. Also, it would be helpful if CMS would specifically define what measures you would like us to report so everyone can do this consistently to provide better comparison. I know there are consistent markers collected in the Stroke DSC.

To be sure INTERMACS is not perfect. Patients are able to opt out or be excluded for other reasons which weakens the results. The mandatory cost is high, and for those not on the primary PI group, it can be difficult to get data outside of what is published in the general quarterly report.

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August 29, 2013

Louis Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00432R

Dear Dr. Jacques:

The American College of Cardiology (ACC) is pleased to offer comments on the proposed decision memorandum for Ventricular Assist Devices (VADs). The ACC is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 43,000-member nonprofit medical society comprised of physicians, nurses, nurse practitioners, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at http://www.cardiosource.org/ACC.

Bridge to Decision

The ACC is disappointed CMS did not use this reconsideration as an opportunity to shift the way it views VAD coverage. As we indicated in our comment letter during the National Coverage Analysis phase, a strictly codified paradigm of bridge to transplant (BTT) and destination therapy (DT) is an outdated view of the potential for VADs. Bridge to decision (BTD) application is supported in the recently published ACC/AHA Guideline for the Management of Heart Failure. That document is available at http://content.onlinejacc.org/data/Journals/JAC/0/05019.pdf. Section 7.4.5 addresses mechanical circulatory support (MCS) and makes several Class IIa recommendation based on Level B evidence:

• MCS is beneficial in carefully selected* patients with stage D HFrEF in whom definitive management (e.g., cardiac transplantation) or cardiac recovery is anticipated or planned.
• Nondurable MCS, including the use of percutaneous and extracorporateal ventricular assist devices (VADs), is reasonable as a “bridge to recovery” or “bridge to decision” for carefully selected patents with HFrEF with acute, profound hemodynamic compromise.
• Durable MCS is reasonable to prolong survival for carefully selected* patients with stage D HFrEF.

Patients who are not eligible for transplant because of pharmacologically irreversible severe pulmonary hypertension may become eligible with a VAD. Patients who are obese or use tobacco but would otherwise be candidates for cardiac transplantation would also benefit from this change. INTERMACS data includes BTD patients, and CMS notes that the Kaplan-Meier survival estimates for this category are similar to those of patients implanted as BTT or DT. The ability to make changes to clinical practices and payment policies based on registry data is a significant reason to capture registry data like this in the first place. We are concerned that the current CMS proposal declines to consider registry data in consort with level B evidence as adequate to cover patients who are designated as BTD. In light of contemporary data, the FDA has indicated that the historical designations of BTT and DT are less pertinent in the present device era, and is moving in this direction. New devices in various pipelines are developing trials with the intent to explicitly seek a “long-term support” indication from FDA without reference to intent of implant, which has been shown to change approximately 30% of the time.

In the absence of BTD coverage, we interpret CMS’ proposed requirement that BTT patients be “active on a waitlist maintained by the Organ Procurement and Transplantation Network” (OPTN) to be a sort of proxy for BTD. Transplant candidates are listed as Status 1A, 1B, 2, or 7. Status 7 patients are transplant candidates who are considered temporarily unsuitable to receive a transplant. These are the very patients for whom the ACC is suggesting CMS should create BTD coverage, qualified in INTERMACS data as BTT-likely, BTT-moderately likely, or BTT-unlikely. Listing all BTT candidates of all statuses could be a simple solution to an admittedly complex problem if CMS declines to create BTD coverage. Alternatively, centers may be forced to designate a greater proportion of patients who are thought to be BTT-likely or BTTmoderately likely as DT. Should CMS finalize this proposal, we seek additional clarification on the application of this requirement in the final decision memorandum.

Such a solution raises significant practical concerns. We fear unintended consequences that CMS may not have fully considered. Some centers currently interpret “listed as a candidate for heart transplantation” to mean that if they are internally listed as an acceptable candidate (or potentially acceptable, pending documentation of sufficient duration of tobacco product abstinence, for example), that this counts as “listed” in the absence of an explicit requirement for listing with OPTN. Given that transplant center outcomes, including deaths on the waiting list, are carefully monitored and publicly reported, centers are understandably reluctant to list a patient who will be subject to the perioperative risk of death without appreciable chance of transplant in the immediate post-VAD implant and rehabilitation period. The risk of performing a transplant in the very early post-VAD implant period is felt by many to be prohibitive, and patients implanted with VAD as a bridge to transplant are often required to complete rehabilitation following implant before being listed or "activated." Thus, centers are exposed to risk of candidates dying on the waiting list, without offering candidates any chance of transplant in this same time period.

Another unintended consequence we predict is the requirement could increase the number of patients listed for transplant or the number of patients receiving DT. The former could increase resource utilization and unfair consumption of the limited donor supply. The latter could lead patients who are not currently eligible for cardiac transplant to receive VAD for DT and subsequently be overlooked as candidates for transplant. Implant intent often changes, and some patients would be designated as DT when they might have become suitable for transplant had they been reevaluated. For all the reasons discussed, the ACC reiterates its recommendation to include a BTD coverage indication.

INTERMACS

CMS states it does not believe registry data will be able to adequately address outstanding evidentiary questions, and that current data are sufficient to conclude that VADs are reasonable and necessary for patients that meet selection criteria. As such, CMS proposes to remove the requirement that facilities implanting devices for DT report data to the INTERMACS registry. At the same time, CMS proposes to include a requirement that facilities track patient outcomes that can be benchmarked with other institutions for continuous monitoring and quality improvement.

The ACC agrees that may be justifiable to remove the requirement for INTERMACS participation for the reasons it was originally implemented. However, as CMS highlights with its proposal to require outcomes tracking, a need exists for quality and outcome reporting and for credentialing and accreditation. We fear the ultimate outcome could be 150 center-specific efforts to recreate INTERMACS. Without a recognized third-party reporting and monitoring system, nonstandard reporting entities or unvalidated methods could create significant confusion and bias through drift in and frequency and quality of data collection. INTERMACS is already standardized, vetted through academic and analytical rigor, and has an established infrastructure for data collection. Much can still be learned from a robust, standardized registry. We realize CMS has concerns about whether it can continue to require data collection to evaluate the utility of a service once it has made a decision that it is reasonable and necessary. We recommend that in addition to including a requirement that facilities track outcomes, functional status, and quality of life, CMS also explicitly state that participation in INTERMACS fulfills these requirements. This would be especially useful and necessary for monitoring these outcomes should CMS make the decision to implement BTD coverage.

Multidisciplinary Team Requirements

In keeping with the evolving nature of coordinated care, CMS proposes specific requirements for the VAD team that extend beyond volume requirements for the cardiothoracic surgeon. The ACC supports the concept of the heart team for these complex patients and finds the proposed requirements for the VAD team to be reasonable. Certification in Advanced Heart Failure and Transplant Cardiology by the American Board of Internal Medicine is an example of one way a cardiologist on the team may demonstrate competence. Other metrics may also exist, so we support the proposed requirements.

Facility Credentialing

In response to an entity’s request to be designated in the NCD as an acceptable facility credentialing organization, CMS proposes to allow such organizations to apply for that designation through a process that will be posted on its web site. Such programs must ensure that credentialed facilities meet NCD criteria and may include additional requirements necessary to operationalize these criteria or administer the credentialing program. The ACC sees an open, rolling application process through which credentialing organizations can apply to be designated as superior to reconsidering the NCD for that purpose. We look forward to the opportunity to review and comment upon the yet-to-beposted process and requirements.

CMS notes the impracticality of requiring currently credentialed facilities to undergo immediate re-credentialing to verify compliance with these updated criteria. It proposes a 1-year transition period to allow facilities currently credentialed by the Joint Commission to adjust their staffing and clinical operations to meet the new facility criteria and to allow credentialing organizations to update their program standards, request and obtain CMS approval to credential facilities to implant VADs as DT, and to verify compliance of existing facilities with the new criteria. Currently credentialed facilities would remain Medicare-approved for 1 year following posting of the final decision to allow for a seamless transition to the new facility criteria.

The ACC is concerned that a 1-year transition period is not adequate for every credentialing organization and then every facility to make a seamless transition. While we believe most facilities already meet the new criteria, we view the potential for a bottleneck to be created when more than 120 facilities clog the system at the same time. We recommend CMS allow more time or latitude, or both, for this transition. One option we suggest is to allow the transition to occur cyclically as facilities progress through certification on a biannual basis. The other would be to allow facilities to attain and then attest to compliance with the new multidisciplinary team requirements during the 1-year transition period. We see positives to both avenues and suggest CMS offer each so that facilities can select one that best fits their needs. Regardless, it is paramount that facilities not face unneeded administrative burdens as they adapt to new criteria.

Other VAD Indications

CMS proposes to clarify that this NCD will “not address coverage of VADs for right ventricular support, biventricular support, use in patients under the age of 18, or use in patients with complex congenital heart disease.” Coverage for these situations will be made by local contractors. This clarification aligns with the rest of the NCD. ACC does not object to it as stated, although we do believe the statement regarding complex congenital heart disease could be confusing. Some congenital patients simply have heart failure and can see positive outcomes with a VAD. They should not be deemed so different from other adults with heart failure. We suggest modifying that definition to say “complex congenital heart disease without heart failure.”

Thank you for considering ACC’s comments on this important issue. Please contact James Vavricek, Senior Specialist for Regulatory Affairs, at 202-375-6421 or jvavricek@acc.org if you have questions or need additional information.

Sincerely,

John Gordon Harold, MD, MACC, MACP, FESC, FCCP, FAHA
President

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Dear Dr. Jacques:

On behalf of the Henry Ford Hospital Heart Failure VAD Coordinators, we are formally submitting our comment on the opening of the National Coverage Determination (NCD) for the VAD coverage requirements in the Artificial Hearts and Related Device policy.

The FDA approves VADs for patients “eligible” for heart transplantation (bridge to transplant) or “ineligible for heart transplantation (destination therapy). The FDA does not require that patients be listed for transplantation under either indication. Medicare’s coverage policy denies access to VADs for many heart failure patients who need them before their candidacy for a transplant can be determined or before they can be listed as an eligible candidate. As VAD coordinators we see patients who may have a modifiable risk factor that keeps them from being transplant listed at the time the patient needs VAD therapy. The issue may resolve after a sufficient time of VAD therapy and the patient then is suitable to receive a heart transplant. The time to determine if these patients are eligible for a heart transplant is after the VAD implant and the patient has had time to recover and can be appropriately evaluated for transplant.

Ultimately, we are trying to do the best thing for our patients and provide a therapy to improve their survival and quality of life. Forcing the centers to place a patient prematurely into a category impacts outcomes, confusion and creates unnecessary risk to patients.

I urge CMS to also recognize that commercial payor coverage allows patients that are eligible or potentially eligible for a heart transplant access to VAD therapy without the “listing” requirement. As VAD coordinators we would like to see consistency across all payor policies and that the language reflects access to VAD therapy for patients as a "treatment for end stage heart failure" refractory to medical therapy.

Thank you for the opportunity to comment

Sincerely,

Sarah Hudson, Henry Ford Hospital, Heart Failure VAD Coordinator

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Dear Dr. Jacques:

On behalf of the Henry Ford Hospital Heart Failure VAD Coordinators, we are formally submitting our comment on the opening of the National Coverage Determination (NCD) for the VAD coverage requirements in the Artificial Hearts and Related Device policy.

The FDA approves VADs for patients “eligible” for heart transplantation (bridge to transplant) or “ineligible for heart transplantation (destination therapy). The FDA does not require that patients be listed for transplantation under either indication. Medicare’s coverage policy denies access to VADs for many heart failure patients who need them before their candidacy for a transplant can be determined or before they can be listed as an eligible candidate. As VAD coordinators we see patients who may have a modifiable risk factor that keeps them from being transplant listed at the time the patient needs VAD therapy. The issue may resolve after a sufficient time of VAD therapy and the patient then is suitable to receive a heart transplant. With the current policy, this situation causes the patient to be classified DT which Medicare has certain coverage criteria that a patient may not fit any more clearly than the BTT criteria. The real time to determine if the patient is eligible for a heart transplant is after the VAD implant and the patient has had time to recover and can be appropriately evaluated for transplant.

Ultimately, we are trying to do the best thing for our patients and provide a therapy to improve their survival and quality of life.

We urge CMS to align the policy to what is happening in clinical practice, and also recognize that commercial payor coverage allows patients that are eligible or potentially eligible for a heart transplant access to VAD therapy without the “listing” requirement. As VAD coordinators we would like to see consistency across all payor policies and that the language reflects access to VAD therapy for patients as a "treatment for end stage heart failure" refractory to medical therapy.

Thank you for the opportunity to comment

Sincerely,
Dmitri Zhuk, Henry Ford Hospital, Heart Failure VAD Coordinator

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On behalf of the Medical Device Manufacturers Association (MDMA), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Ventricular Assist Devices for bridge to transplant and destination therapy (CAG-00432R). MDMA represents hundreds of innovative medical technology companies, and our mission is to ensure that patients have timely access to life-saving therapies.

Ventricular Assist Devices (VAD) are innovative medical devices surgically implanted to one or both intact ventricles and are used to assist a damaged or weakened native heart in pumping blood. Currently, there are two primary indications for this technology. The first is a temporary therapy in patients who are being considered for a cardiac transplant (bridge to transplant). The second indication is as a permanent therapy for those who are ineligible for cardiac transplantation (destination therapy).

While VAD technology offers tremendous promise to Medicare beneficiaries, MDMA is concerned that future access may be limited. On August 1, 2013, CMS issued the Proposed Decision Memo for Ventricular Assist Devices for bridge to transplant and destination therapy. In the proposal, CMS states that the evidence is insufficient to support changes to the current patient selection criteria regarding bridge to candidacy. MDMA strongly disagrees with CMS’s position. We also comment that the INTERMACS registry, which has been widely accepted as the international standard in VAD outcomes research supporting the bridge to candidacy question, has the data to support coverage determination. MDMA believes that limiting access to “listed only” patients prevents CMS beneficiaries from accessing VAD therapy in a timely manner. To this end, CMS should eliminate the “listing requirement” at the time of implant for bridge to transplant beneficiaries. Patients should have access to VAD therapy if they are undergoing evaluation to determine transplant eligibility. The comment from MDMA is consistent with clinical practice as evidenced in the INTERMACS registry and coverage for non-Medicare beneficiaries.

CMS should reconsider its coverage policy decision for several reasons. The current Medicare coverage policy of VADs does not accurately reflect clinical practice and the vast majority of commercial insurers’ policies. The FDA approves VADs for patients who “are at risk of death from refractory end stage left ventricular heart failure and candidates for cardiac transplant” (bridge-to-transplant) or are “not eligible” for cardiac transplantation (destination therapy). The FDA does not require that patients be listed for transplantation under either indication. By requiring a patient, either for bridge to transport or destination therapy, be listed, Medicare’s coverage policy denies access to VADs for many patients who need implants before their candidacy for a transplant can be determined and at a time that the clinical course of their disease may not be appropriate for listing. The current CMS policy would also negatively impact a beneficiary who needs a VAD to stabilize their condition while providers evaluate the individual’s eligibility for transplant. In these cases, the patient would not receive a VAD as destination therapy because the providers have not concluded that the patient is ineligible for transplantation, but the patient also would not meet Medicare’s criteria for coverage for bridge to transplant because the patient is not listed as a candidate for transplant. The process of confirming that a patient cannot be listed at that time and also confirming that they are not eligible adds a considerable amount of time to the process. The additional time can be harmful to the patient’s well-being and will add considerable expense while they are being evaluated at the hospital. We believe this runs counter to the objectives of CMS.

CMS’s proposed coverage policy also conflicts with commercial insurers that cover VADs for individuals who are, or could become eligible for transplant without requiring the patient to be listed as a candidate for transplantation. Because of the similarities in the patient population, many in the physician community believe that there is no clear clinical distinction between bridge to transplant and destination therapy. For instance, there are patients who may receive a VAD as bridge to transplant but ultimately never receive a transplant due to the clinical course. Furthermore, patients who receive the device as destination therapy only differ from other patients in a center’s assessment of their potential likelihood of becoming a transplant candidate.

The proposed CMS coverage policy for VADs will create bureaucracy and another artificial barrier of access for Medicare beneficiaries who need life-saving technologies and prolong the poor quality of life suffered by late stage heart failure patients. CMS should eliminate the listing requirement at the time of implant for bridge to transplant patients. These patients should be eligible to receive VAD therapy if they are undergoing evaluation to determine transplant eligibility. This is consistent with clinical practice and coverage for non-Medicare patients.

MDMA appreciates the opportunity to provide comment on this important issue to ensure that all Medicare beneficiaries who need access to this life-saving technology are able to utilize it.

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August 26, 2013

Re: CAG-00432R

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

As part of our mission, the Heart Failure Society of America (HFSA) encourages primary and secondary preventive measures to reduce the incidence of heart failure; to serve as a resource for government, private industry, and health care providers to facilitate the establishment of programs and policies that will better serve the patient.
HFSA is dedicated to the integrated care of patients with heart failure. Not defined by any related procedure, HFSA principles include equitable access to heart failure therapies for all patients, and helping each patient to select from all available therapies that which is most appropriate for him/her.

We appreciate the commitment of CMS to advancing the care of patients with advanced heart failure. We recognize the key role CMS has played in helping to establish the use of ventricular assist devices to improve the length and quality of life for those patients most likely to benefit. As our society works to provide clinical care, guidelines, and policy regarding the 2% of the U. S. population diagnosed with heart failure, we feel also the obligation for responsible allocation of both technologic and personnel resources across the broad spectrum of patients.

The current proposed coverage policy and the related MEDCAC meeting in November 2013 reflect the timely and thoughtful review of CMS in re-evaluation of this therapy. On behalf of the HFSA, we would like to summarize our responses to 3 of the major proposed changes:

1. We are very disappointed that CMS proposes to disadvantage approximately 36% of patients currently receiving VADs by requiring that they either be listed for transplantation before their candidacy has been responsibly established, or be prematurely declared ineligible for transplantation as required by the previous approval process for destination (lifetime) therapy.
2. We applaud the establishment of more specific criteria for centers implanting ventricular assist devices. This includes the requirement for a recognized palliative care specialist and for “at least one cardiologist trained in advanced heart failure” with specific competencies in evaluation and management of VADs and heart transplants. We propose that the certification of this specialized cardiologist is that established by the American Board of Internal Medicine certification in the secondary subspecialty of Advanced Heart Failure and Transplant.
3. We oppose the removal of the center requirement for participation in an established independent national VAD registry, which we feel is vital to provide real-time tracking of outcomes, alerts to adverse events, guidance in best practices, and timely response to changing trends with new devices that cannot be relegated to individual device manufacturers. The breadth and timeliness of outcome data from a national registry is required to best inform patients as we formalize shared decision-making with them regarding complex interventions. Furthermore, it is the only route through which individual centers can meaningfully track and improve their own outcomes by comparison of parallel data to national benchmarks, as specified by the CMS policy.

Explanation of (1) – (3):

1) The initiation of the NIH Artificial Heart Program was initiated in 1964. The goal of developing mechanical circulatory support for permanent cardiac replacement with mechanical support was from cardiac transplantation, which was first performed in humans later in the same decade. As the number of transplant centers and candidates increased, mortality on the waiting list approached 30% in the 1980’s, and the collaboration was forged between mechanical circulatory support innovation and cardiac transplantation (Developmental History of Mechanical Circulatory Support, JK Kirklin and OH Frazier, in Mechanical Circulatory Support, ISHLT Monograph Series 1 (2006) p1-8). The transplant waiting list was then described as the “laboratory” for the initial human experiments with new implantable devices. Successful support in transplant candidates then led to investigation of lifetime “destination” therapy in patients considered ineligible for transplantation, the REMATCH (Randomized evaluation of mechanical assistance for the treatment of congestive heart failure) Trial. The positive results were published in 2001, leading to FDA approval of the Heartmate VE VAD for destination therapy in 2002, with Medicare approval in 2003. This approval was based on 129 patients from the REMATCH trial, of whom 68 were randomized to an implantable pulsatile pump, 22 were alive on device at 1 year and 5 at 2 years. The field has evolved rapidly over the past 10 years, during which INTERMACS has collected data on over 10,000 patients who have received implantable devices, with over 1100 patients alive on devices without transplant for over 2 years.

Although the indications for device approval were dichotomized as EITHER bridge to transplant or lifetime therapy, the actual use has evolved during the experience of the last 10 years (Figure 1). After the HMII continuous flow device was approved for bridge therapy in April 2008, there was an immediate increase in implantation, but more increase in the patients described as bridge to candidacy/decision than in those already listed for transplantation. Even after this device was approved for destination therapy in January 2010, there remained a substantial portion of patients for whom a decision regarding their ultimate eligibility for transplantation could not be made at the time they needed device implantation for survival. Since the introduction of the continuous flow device, INTERMACS demonstrates a steady decline in the patients receiving devices as listed transplant candidates, from 48% before 2010 to 25% in 2010-2011 and 19% in 2012, when 750 patients, over a third of all device implants, are receiving the device before a final decision can be made regarding transplant candidacy.

Failure to recognize this substantial group of device recipients will adversely impact their outcomes. If the proposed change in coverage is realized, they may be placed on the waiting list for transplantation prematurely, before their eligibility has been firmly established both for medical and psychosocial profile of a good outcome with transplantation. Patients may not have sufficient time to undergo thorough teaching about cardiac transplantation, and may be listed for transplantation without fully informed consent. Furthermore, increasing the number of patients listed for transplantation will disadvantage the other listed candidates. There are already 50% more patients listed than can receive a transplant, for the supply of donor hearts in the United States remains limited to about 2200 while over 3000 patients are added annually. Further inflation of the waiting list will further prolong waiting times; over half of patients waiting at the highest priority have already been waiting over 6 months.

On the other hand, to mislabel patients as ineligible for transplantation due to potentially reversible contra-indications is also a serious error. As indicated in Figure 2, eligibility for transplantation is a dynamic state after implantation of devices, which can both reverse and cause contra-indications. Furthermore, there are patients who prefer to have ventricular device placement although they are otherwise eligible for cardiac transplantation. Should these patients be labeled as ineligible? We feel that it is vital for patients who are not listed for transplantation prior to VAD implantation to retain access to consideration for cardiac transplantation, which is not endorsed by the proposed restrictive indications.

As was discussed at length by multiple presenters at the MEDCAC meeting, we would support the proposal to re-define the two patient populations receiving implantable ventricular assist devices as 1) patients requiring these devices to support life until a heart becomes available for transplantation and 2) patients requiring these devices to support life with advanced heart failure. The 2013 ACC/AHA Heart Failure Guidelines have endorsed as a Level IIa recommendation: “Durable MCS is reasonable to prolong survival for the carefully selected patient with Stage D heart failure.”

2)The HFSA strongly recommends that the cardiologist training requirement specifically be the American Board of Internal Medicine (ABIM) certification in the secondary subspecialty of Advanced Heart Failure and Transplant. This requires a designated clinical year of training in additional to the curriculum and years required for General Cardiology, following which the candidate must pass a written examination. In order to be eligible to sit for that examination, the candidate must have completed 12 months of fellowship at an institution accredited to provide Advanced Heart Failure and Transplant training, including specific documentation of active participation in decisions regarding VAD implantation, from pre-operative evaluation through early post-operative and long term outpatient management, evaluation of patients for cardiac transplantation and care of patients after cardiac transplantation, and additional requirements in many programs including performance and interpretation of cardiopulmonary exercise tests, primary leadership of family meetings regarding decisions in advanced heart failure, and proctored discussions with patients regarding options for end of life care. Requiring ABIM certification would better assure the exposure and competence as well as the commitment of the cardiologist designated for a VAD program. We recommend that CMS add ABIM certification in Advanced Heart Failure and Transplant to the definition of a qualified heart failure cardiologist. As of 2012, there were 484 certified Advanced Heart Failure and Transplant cardiologists.

3) We consider that mandatory reporting to an ongoing national VAD registry is vital to ensure quality for patients and progress in the field of mechanical circulatory support. Monitoring Outcomes and Improving Practice: Although the validation of the initial indications for destination therapy, based on 68 VAD patients, has since been validated through the experience of INTERMACS with over 10,000 patients, the field continues to evolve rapidly. CMS has indicated that “the procedure, the device and post-operative care will continue to be refined in coming years and it is important to have a means of assessing the quality of patient care over time to ensure that outcomes are maintained or ideally improved. Responsible stewardship of the resources necessary to reimburse this technology requires continued refinement of information regarding practice patterns and outcomes. The shift away from implantable devices in the “crash and burn” patients is an example of the improvement triggered by INTERMACS data, as shown in Figure 3.

Recognizing Trends to Inform Patient Decisions: The utilization of devices is changing rapidly even among the approved populations with approved devices. Newer devices for which there is not yet long-term data will require careful comparison to the devices well-represented during the past 5 years. Without an independent registry such as INTERMACS, we will be left only with the data chosen for presentation by each device manufacturer or clinical program, and we will be making life and death decisions comparing apples to oranges. Although LVADs are currently approved for INTERMACS level 4 patients and some level 5 patients, fewer than 1 in 5 patients implanted thus far have been on oral therapy at home, so outcomes in the ambulatory population will be critical to track objectively. When death is less imminent, decision-making for patients and families according to individual goals and priorities become more complex. The AHA Scientific Statement on Decision-Making in Advanced Heart Disease (Allen et al, Circulation 2013 has emphasized “Whether to pursue these therapies represents one of the most difficult decisions that patients and clinicians can make”. The scope and contemporary nature of registry data is crucial to provide patients with the detail, relevance, and balance of information that they seek regarding anticipated outcomes with a life-changing intervention such as mechanical circulatory support.

Quality Assurance and Improvement for Hospitals Implanting VADs

CMS has indicated “Facilities must track patient outcomes including survival, adverse events (e.g. bleeding, infection, stroke, and device malfunction), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement”

It is not feasible for individual institutions to collect and analyze their own data in the standardized format to allow comparison with multiple other sites around the country. The outcomes depend heavily on the patient populations and the types of support offered. It would be possible to have extremely favorable outcomes at a single site by turning down all but the healthiest patients, who may not derive the desired benefit. As indicated by CMS, “registry data will permit facilities to compare their LVAD experience against that of other implanting facilities to determine the quality of their performance overall as well as to assess whether an individual patient's care and progress in recovering from the procedure is meeting normative standards”.

We would strongly recommend that CMS continue to endorse and mandate the practice of contributing the data regarding both patient selection and device outcomes to a national registry using the definitions and data fields that have been established by a broad consensus of the clinical practice community for mechanical circulatory support. We include a sample of the types of data currently provided by INTERMACS to each hospital for comparison of its outcomes to national benchmarks. Furthermore, the provision of this data by time intervals facilitates the feedback of each hospital to document selection and progress of its own quality improvement initiatives, as encouraged by CMS.

We appreciate the opportunity to provide input on behalf of the HFSA to represent the interests of the heart failure population and our professional members from multiple disciplines who are dedicated to caring for them. Please let us know if we can provide additional data to assist CMS in their further deliberations on the indications, role of the registry, and certification of responsible VAD centers.

TABLE 1.

Sample of Information Provided Quarterly by INTERMACS
To Each Hospital for Comparison to National Benchmarks:
Focus for Internal Quality Assurance and Improvement

Patient Selection Before VAD – Examples of fields for comparison

	Your Hospital	National INTERMACS*
Age > 60		43%
African-American recipients		22%
% RVAD inserted with LVAD		6%
% beta blocker use in past yr		73%
Contra-indications to transplant		e.g. Age 18% Obesity 15% Chronic renal disease 15% Pulmonary HTN 11% Current smoker 5% Limited social support 5%
% Patients on dialysis		2.3%
% moderate-severe TR		43%

	Your Hospital Before 2010	Your Hospital 2010-2011	Your Hospital 2012	INTERMACS Before 2010	INTERMACS 2010-2011	INTERMACS 2012
% Profile 1				29%	15%	15%
Profile 2				43	40	38
Profile 3				15	26	28
Profile 4				9	13	14
Profile 5				2	3	3
%Listed for transplant				48%	25%	19%
Likely				27	23	23
Moderately				10	10	10
Unlikely				3.9	3.5	3.0
Destination Therapy				8.0	36	44

*Through 2012

Outcomes – Survival (available for each Profile and Intent for comparison to National outcomes)

	Your Program	INTERMACS National Data* Continuous Flow Only (N=6581 pts)
30 Days		96%
180 days		87%
360 days		81% (N=2628)
2 years		70% (N=1001)
3 years		59% (N=252)

	Your Program	INTERMACS National Data*
Length of Stay All LVAD only		26 days (includes pulsatile)
Length of Stay All BiVAD		53 (includes pulsatile)

*Through 2012

Examples of Adverse Event Tracking – Rate per 100 patient months in interval

	Your Program	Your Program	INTERMACS	INTERMACS
	Per First 100 days	After 100 Days	Per First 100 Days	After 100 Days
Infection			19	5.3
Bleeding			26	1.3
Neuro event			4.1	1.7
Device malfunction			2.5	3.5
Rehospitalization			17	15

Figures

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As the Surgical Director of Heart & Lung Transplant & Mechanical Circulatory Support Programs & the Chief of Advanced Cardiac Surgery at Florida Hospital, I am urging you to use this opening to modify the language to align the coverage with what is currently happening in clinical practice.

Currently Medicare requires that these beneficiaries being implanted as BTT be approved and “actively listed” as a candidate for heart transplantation before their candidacy for a transplant can be determined.

Many times patients present acutely and require VAD support before they can be evaluated or have a contraindication to transplant at the time but with VAD support often these contraindications can resolve and allow for transplant listing at a later date. Transplant candidacy should be addressed after the patient has recovered from the VAD implantation and is doing well clinically.

Destination Therapy is the designation that is given to those patients who are to “be determined to not be a candidate for heart transplantation. As many Surgeons have experienced, a fair number of these patients will go back and forth between these two categories before a true clinical designation can be determined.

It would be a better designation to require a multidisciplinary team evaluation approach for all ventricular assist device implants than require centers to prematurely designate which category the patient fits into BTT or DT at the time of VAD implant, as we know there is subsequent cross over in each designation.

My experience is that our Commercial payers include patient who are undergoing transplant evaluation to be included in the BTT category and do not require the facilities to “List them as Transplant candidates.” Thus I feel that Medicare’s Ventricular Assist Device NCD needs to be revised and updated to reflect not only what is happening in clinical practice but align with the commercial health plans in the market.

As was briefly outlined, The Florida Hospital Transplant Institute strongly encourages CMS to take this opportunity to align its National coverage determination within the reality of clinical practice, be consistent with many commercial payers and provide Beneficiaries’ access to this life-saving technology.

Sincerely,

Hartmuth Bittner, M.D., PhD

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Two comments:

(1)To a large extent, categorizing patients as BTT or DT is arbitrary and misleading. Some patients are clearly BTT and some are clearly DT. Unfortunately a number of patients are neither. That is, they are a "bridge to decision". At transplant centers these patients will be appropriately classified. Those that are listed (at these centers) will rightly be called BTT. Those that may be BTT but are not yet listed (i.e. bridge to decision) will simply be placed in the category of DT and then later converted to transplant candidacy as their condition improves. This should represent a small percent of the patients. The DT patients will clearly be listed correctly as DT.

The problem is what will happen at non-transplant centers. The team at the non-transplant hospital may have an excellent BTT patient but for that patient to be implanted at the non transplant hospital, referral to a transplant center will now be needed (in order to get the patient listed). How will this play out? The acutely ill patient will need to be transferred and the chronically ill patient will need to be referred as an outpatient. Essentially that means that the non-transplant center will lose the acutely ill patient because once he or she is listed the patient will not then be sent back to the non-transplant hospital for implantation. Rather, the implant will be performed at the transplant center - as it is illogical to transfer the patient back and more likely than not the family will not want to go back. The same may occur with the outpatient. In order to avoid this scenario the non-transplant center will find it necessary to inaccurately label all of their BTT patients as DT patients simply to avoid losing the implant and the associated revenue. CMS will never know the difference - will they? The only way that they would know is if DT labeling precluded subsequent transplantation. That, however, is is impractical for the reasons noted above - some patients are "bridge to decision" and depriving them of the opportunity to be transplanted at a later time if they improve enough to be a transplant candidate is unfair.

What all of this means is that all of the BTT and DT data will be inaccurate simply because the initial classification will be wrong at the non transplant centers (for the wrong reason - to get reimbursed).

Please understand that I am not objecting to the change. In fact, I support it. I am just informing CMS of the consequence of the change.

(2) I notice that board certification in HF and Transplant Medicine is not a requirement but perhaps it should be. Management of VADs is not all that easy especially when subtle problems arise and although many cardiologists believe that they are competent to provide care to such patients, this is not always the case. The insurance companies that have dealt with these issues repeatedly at non transplant programs and can certainly vouch for this observation. Management of LVADs is of the same complexity as management of ICDs (which is mostly done by Board certified EP MDs). Hence, I would support a requirement for Board certification.

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August 28, 2013

Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00432R – Proposed Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy

Submitted electronically via: CAGinquiries@cms.hhs.gov

Cleveland Clinic (CC) is a not-for-profit, integrated healthcare system dedicated to patient care, teaching and research. Our health system is comprised of a main campus, eight community hospitals and 18 family health centers with over 3,000 salaried physicians and scientists. Last year, our system had nearly six million patient visits and over 165,000 hospital admissions. For the 19th consecutive year, Cleveland Clinic’s heart program has ranked as the best in the nation, earning the No. 1 ranking in U.S. News & World Report’s “2013-14 Best Hospitals.” Since 1994, no hospital in the country has ranked higher than Cleveland Clinic in cardiac care.

We appreciate the dedication of the Agency staff on behalf of the Medicare Program and the work they devote to its administration. We believe it is important for hospitals to share information with CMS so the Agency has a better understanding of the challenges and practicalities faced by the hospitals regarding proposed changes which influence hospital activity. The following is a description of the changes CMS has included in the above captioned proposed Decision Memo and the response to the changes from Cleveland Clinic.

CMS Proposal: 1. Ventricular assist devices (VADs) for bridge to transplant (BTT)
a. For the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, we clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network at the time of VAD implant.

CC Response: We disagree with this requirement as we do not believe that patients should be required to be UNOS listed as a candidate for heart transplant to receive a VAD. Our position is supported by the fact that the FDA approves VADs for patients who are “eligible” for heart transplantation (bridge-to-transplant) or “ineligible” for heart transplantation (destination therapy). The FDA does not require patients to be listed for transplantation under either indication. Additionally, the majority of commercial insurers cover VADs for patients who are eligible or could become eligible for a transplant, without requiring the patient to be actively listed as a candidate for transplantation. In fact, many physicians believe that there is no clear clinical distinction between bridge-to-transplant and destination therapy as the patient populations are so similar. We believe this decision memo unnecessarily denies access to VADs for many patients who need them before their candidacy for a transplant can be determined or before they can be listed as an eligible candidate. Listing a patient on the waitlist is a complex process that requires not only an internal review to determine whether the patient should be listed but it is also vetted through the state of Ohio Solid Organ Transplant Consortium. This process may take up to five days. Therefore, under this proposed policy, even those patients who are deemed as eligible will be forced to wait additional time before they will be allowed to have the procedure. Hence, the patient could be exposed to unnecessary risk and organ failure while awaiting administrative approval and actual UNOS listing. The clinicians will be forced to list patients or designate them as DT (destination therapy) knowing that a significant portion of patients improve on LVADs and become transplant eligible. Those not listed and not meeting CMS requirements for DT reimbursement will potentially be denied life sustaining therapy due to the stipulation for UNOS listing as proposed. In summary, this will jeopardize patient safety and outcomes, increase expense (UNOS listing fees), and require caregivers to make sometimes inaccurate assignment with respect to anticipated treatment outcomes.

We believe VADs should be allowed to be used for patients who have not been listed as a candidate for heart transplant but approved as candidates by the implanting hospital transplant selection committee. This will allow our physicians to provide clinically appropriate treatment regimes and devices based on sound medical judgment.

CMS Proposal: 1. Ventricular assist devices (VADs) for bridge to transplant (BTT)
b. Remove the existing requirement that a "Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the Medicare-approved heart transplant centers should determine patientspecific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available."

CC Response: We agree with this proposal.

CMS Proposal: 2. VADs for destination therapy (DT)
a. The evidence is insufficient to support changes to our current patient selection criteria for coverage of a VAD as DT.

CC Response: We disagree with this conclusion. We believe that the classification between Bridge to Transplantation and Destination Therapy can be “clinically artificial as patients may transition from one designation to another depending on the resolution or occurrence of comorbid conditions or patient choice.”¹ Further, we believe that “transplant eligibility is a dynamic rather than a static consideration and must be continually reevaluated with changes in the patient’s clinical condition.”² Oftentimes, patients are acutely ill and their eligibility for transplant is impossible to assess because of the comorbidities that they are present at the time of assessment. We believe that CMS should develop an additional category “Bridge to Decision” because “advanced heart failure is a dynamic illness and the management approach should be dictated by the patient’s clinical condition rather than an arbitrary distinction.”³

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)
We would like to note that that INTERMACS data and publications has shaped the field and helped to improve patient care. We continue to believe that support for INTERMACS is crucial as it has played a central role in better understanding mechanical circulatory support. . We believe that the removal of the requirement for participation in INTERMACS will result is a reduction in the quality from individual implanting centers and hinder improvements in outcomes for the entire nation. A review of the Google Scholar search engine shows 791 results since 2012 alone and over 1900 total when searching PubMed. INTERMACS is now poised to provide center specific data with national benchmarking to assist centers with quality assurance. We feel it will be mistake for CMS to not fully support mandatory participation in INTERMACS.

Thank you for conducting a thoughtful process that allows us to provide input on such important issues and for your consideration of this information. Should you need any further information, please don’t hesitate to contact me.

Sincerely,

/s/
Nader Moazami, MD
Surgical Director
Kaufman Center for Heart Failure
Heart and Vascular Institute

/s/
Randall C. Starling, MD, MPH, FACC, FESC
Vice Chairman Cardiovascular Medicine
Section Head, Heart Failure Center
Medical Director, Kaufman Center for Heart Failure
Heart and Vascular Institute

/s/
Bruce W. Lytle, MD
Chairman, Heart and Vascular Institute
Staff, Thoracic and Cardiovascular Surgery
Professor of Surgery

1 Acker MA, Pagani FD, Gattis Stough W, Mann DL, Jessup M, Kormos R, Slaughter MS, Baldwin T, Stevenson L, Aaronson KD, Miller L, Naftel D, Yancy C, Rogers J, Teuteberg J, Starling RC, Griffith B, Boyce S, WestabyS, Blume E, Wearden P, Higgins R, Mack M. Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices inthe United States. Circ Heart Fail. 2013;6:e1–e11.
2 Id
3 Id

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Currently, patients implanted with LVAD must either be listed for heart transplantation on an approved heart transplant program (BTT), be declined permanently to be added to a transplant list(DT) or have undergone open heart surgery and fail to come off cardiopulmonary bypass (Post cardiotomy). However, several patients with end stage heart failure clearly fail to fit into one of these criteria or transition from one criteria to the other. For example, a patient whose weight is above the weight criteria for transplantation will have to be implanted as destination therapy. Approval from insurance coverage is obtained as destination therapy. However as the patient loses weight and falls into the weight limit for transplantation he will need to move from DT to BTT list. Several payers deny listing of this patient for transplant since he was initially implanted with the intention for destination therapy.

As a treating physician, being forced to declare a patient "transplant eligible or ineligible" at the time of implant is very difficult.

My suggestion to CMS is to eliminate this arbitrary criteria and allow the patient to be implanted as "treatment for end stage heart failure" refractory to medical therapy. The future of this patient is unknown at the time of implant. A permanent complication may make him ineligible for transplantation. An improvement in his clinical condition may make him eligible for transplantation or even for recovery / explantation.

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Many times a definitive "BTT" or "DT" indication is difficult to define pre-implant of an LVAD. Many patients are in critical cardiogenic shock and unable to undergo the necessary testing (per CMS to include colonoscopies, PAP smears, dental eval, etc) for a full transplant evaluation. Also, declaring them "DT" patients due to lack of evaluation is not accurate either. I would propose the stipulation of active listing NOT be changed as this will promote confusion to patients, families, and may compromise UNOS compliance within transplant centers.

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CAG-00432R

Regarding the proposed 2013 National Coverage Decision for VAD DT and BTT, I have important concerns regarding national registry reporting requirements. I strongly recommend maintaining the requirement of reporting to INTERMACS, supported by Joint Commission VAD certification, which requires that all non-trial LVAD patient data be reported to INTERMACS. INTERMACS collects critical data on quality of life and functional capacity which are important outcomes that "patients care about". If we do not collect sufficient data on HRQOL outcomes and functional capacity, which could occur through reporting to multiple registries, we will not be able to (1) adequately determine changes in these outcomes from before to after implant, which would inform patient decision making as they consider surgical options and (2) identify outcomes wherein patients do poorly after implant, which could guide interventions to improve outcomes. It would be extremely difficult to collecct sufficient data and compare HRQOL outcomes with other institutions if there was no standardized methodology to collect these data, which has been a limitation of meta-analyses, that include HRQOL outcomes, in multiple other patient populations. INTERMACS has implemented standardization of data collection, recently reported in the Journal of Heart and Lung Transplantation: Grady K et al. Beyond Suvival: Assessing Function and Quality of Life with Mechanical Circulatory Support J Heart Lung Transplant 2013;31(11):1158-1164. This problem is highly likely to occur with reporting of VAD data to multiple registries. INTERMACS HRQOL and functional capacity data are also highly useful on an institutional level re quality initiatives and ability to benchmark with INTERMACS overall, as well as useful from an overall perspective as these data provide a rich and important source of data for research of this critical patient-centric outcome. Thus, I respectfully request that INTERMACS remain the only registry regarding reporting requirements, in order to adequately measure and analyze HRQOL and functional capacity outcomes after mechanical circulatory support.

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To whom it may concern:

I am writing on behalf of the Ventricular Assist Device program at the Hospital of the University of Pennsylvania. We would like to respond to the proposed change by CMS that will change the listing requirement for BTT patients to now be "actively listed" on the transplant list. Our program feels that by changing this wording we are potentially denying many patients lifesaving treatment for their advanced heart failure. The wording also does not match up with the FDA approved indication for bridge to transplant, which states that a VAD patient must be "eligible" for heart transplant. Not every patient is a clear BTT or DT candidate. By forcing hospitals to chose between these two categories will lead to misuse of the destination therapy category. This will not be a true representation of the true destination therapy population outcomes.

Patients that have modifiable risk factors such as weight, may not meet the hospitals policy for BMI requirement for OHT. We are then forced to inaccurately label this patient as "DT" if they actually meet all criteria or we would have to deny such a patient lifesaving therapy. We feel that patients should be deemed "VAD eligible" without having to be categorized BTT or DT. We would like CMS to consider changing the wording to "be an eligible candidate for heart transplantation, patient may be actively listed or under evaluation for transplantation"

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PLEASE CLARIFY BELOW PROPOSAL:

The Centers for Medicare & Medicaid Services (CMS) proposes the following changes to the current national coverage determination (NCD).

1.Ventricular assist devices (VADs) for bridge to transplant (BTT)

a.For the existing requirement that a patient is approved and listed as a candidate for heart transplant by a Medicare-approved heart transplant center, we clearly identify that the patient must be active on the waitlist maintained by the Organ Procurement and Transplantation Network.

QUESTIONS:
1. Does this mean BTT VAD will only be covered if patient is OPTN/UNOS listed as Status 1A, Status 1B, or Status 2?

2. Will BTT VAD be covered if patient is OPTN/UNOS listed as Status 7?

THANK YOU!

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Currently, many patients receiving a LVAD have an undetermined future and treatment path at the time of device implantation. The decision whether a patient is transplant eligible when they present is not as clear as it was years ago. In addition, some patients will recover and have their VAD removed, some "DT" patients become transplant eligible and many patients considered as possible candidates for transplant never meet program requirements. As a treating physician, being forced to declare a patient "transplant eligible or ineligible" at the time of implant is very difficult, frequently can delay therapy and is confusing to patients and families. I would suggest that CMS eliminate this arbitrary partitioning of patients and allow appropriately certified centers to implant life saving mechanical assist devices based on the documentation of advanced heart failure refractory to medical therapy. Whether the patients keep their device, go on to transplant or have device removal for myocardial recovery should be unrelated to the initial decision making.

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In the proposed decision you state that evidence is sufficient or not sufficient on several issues. So what is the evidence that a palliative care specialist is necessary? Likewise, almost all centers will have social workers and coordinators available, but why put these job descriptions in as prerequisites? Some centers might manage patients in a different way. It seems to me that the proof of the success of the LVAD center is the outcome of the patients not the number and job descriptions of the people on the team. This description looks like typical govt/union employment padding.

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To Whom it May Concern:

On behalf of the Intermountain Heart Institute Artificial Heart Program and our Surgical Director, Dr. Bruce Reid, I am writing regarding the CMS National Coverage Determination (NCD) Ventricular Assist Device (VAD) listing issue. Specifically, the way the current NCD is written, access to VADs for advanced heart failure patients who need this life saving therapy is delayed while trying to determine their candidacy for a transplant and thereby list them as an eligible candidate. Medicare currently requires that a beneficiary being implanted as Bridge to Transplant (BTT) “be approved and listed as a candidate for heart transplantation” or they must “be determined to not be a candidate for heart transplantation” if the implant strategy is destination therapy (DT). However there are many patients who present acutely, in a critically ill state, and require support before full evaluation can occur, or have a contraindication to transplant at the time of implant that may resolve after a period of support. These patients represent nearly 40% of those implanted with mechanical support. Since they cannot be listed for transplant and in order to qualify for implant must meet the criteria for destination therapy, including the requirement that they are not transplant candidates (even if the eventual goal may be transplant), this puts the physician in the precarious position of delaying treatment while creating unnecessary risks to the patient. Furthermore, this process is confusing and a source of tremendous stress for the patient and their family.

In contrast to the Medicare coverage policy, the majority of commercial insurers cover VADs for patients as BTT not only for those who are listed for transplant, but also for those who are intended for transplant but are under evaluation and not yet listed. We feel Medicare’s policy is outdated and should be revised to reflect the current best practices of other payers.

We would like to propose that instead of requiring physicians to assign beneficiaries to one of the BTT or DT categories which are often difficult to determine at the time of implant, CMS should align its coverage policy with clinical practice by simply aligning the language for BTT coverage for VADs to: “be approved and listed as a candidate for heart transplantation OR currently under evaluation for transplantation”. This should not result in an increase in medical expenditures on mechanical support, but rather will provide clarity for patients, families and physicians.

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CMS policy concerning qualifications for DT VAD center in relation to number of VADs implanted by the surgeon in the past 36 months should clearly identify implantable versus paracorporeal temporary VADS - as the policy currently reads it is unclear specifically whether this pertains to implantable or temporary paracorporeal systems and from a management /surgical standpoint there is significant difference in the training and management between the systems - as it currently reads a nontransplant center implanting 10 acute paracorporeal systems in the past 36 months and rapidly transfering those patients to a transplant/VAD center and never actually managing the systems or the patients could meet CMS requirements - this is not an uncommon practice; primary surgeon versus assistant surgeon as a qualifier ; active in the past year is not clearly defined and as the policy reads a single VAD within the past year would potentially qualify and certainly would not reflect a high level of compentency. The policy changes in no way addresses institutional resource issues completely - do DT VAD centers need to address compentency in implementing and successfully discharging patients on implantable systems prior to obtaining VAD DT center certification , Do DT VAD centers have the responsibility/requirement as an implanting center to provide 24/7 r access /coverage for their implanted patients - phone avaliability , surgeon with working knowledge of VAD systems on call , HF cardiologist with working knowledge of VAD systems on call ;Do DT VAD centers need to educate the EMS sevices and ED departments within the surronding areas of their implanted VAD patients concerning the management of these systems.

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