Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Transcatheter Aortic-Valve Replacement (TAVR)

Policy #:11.02.25b


This medical or claim payment policy will be applicable to the Company’s Medicare Advantage products for dates of service up to and including 12/31/2014. Medical and claim payment policies that will be applicable to the Company’s Medicare Advantage products for dates of service on or after 01/01/2015 will be accessible via a separate Medicare Advantage policy database that will become available on 10/01/2014. This notification does not impact the Company’s commercial products.



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Intent

The intent of this policy is to communicate the coverage positions for transcatheter aortic-valve replacement (TAVR).
Description

Aortic stenosis is a narrowing of the aortic valve opening that causes an obstruction of the blood flow from the left ventricle into the ascending aorta. There are many conditions that may contribute to aortic stenosis, such as calcification of the aortic valve, rheumatic fever, and congenital anomalies.

When there is an elevated level of calcium traveling through the bloodstream, calcium deposits can occur, hardening the tissue and causing a narrowing, or stenosis, of the valve, which diminishes blood flow through the valve. This is referred to as calcification of a valve. Calcification risk factors include advanced age, male gender, smoking, hypertension (elevated blood pressure), and hyperlipidemia (an elevation of lipids or fats in the blood stream). When left untreated, severe aortic stenosis can result in heart failure and even sudden cardiac arrest.

Transcatheter aortic-valve replacement (TAVR), also called transcatheter aortic valve implantation (TAVI), has been developed as an alternative treatment for individuals with severe aortic stenosis who are either high-risk open-heart-surgery candidates or not surgery candidates at all. The procedure is performed percutaneously, most often through the transfemoral artery approach. It may also be performed through the subclavian artery approach and transapically using mediastinoscopy.

On November 2, 2011, the Food and Drug Administration (FDA), approved the premarket approval application (PMA) for the SAPIENTM Transcatheter Heart Valve System (Edwards LifeSciences, Irvine, CA), which uses a transfemoral approach for individuals with severe aortic stenosis and a calcified aortic annulus (a fibrous ring in the wall of the root of the aorta), who are not candidates for open-heart procedures; who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement; and in whom co-morbidities exist that would not preclude the expected benefit from correction of the aortic stenosis. In October 2012, an additional FDA premarket approval (PMA) was granted for the Edwards SAPIENTM (Edwards LifeSciences, Irvine, CA) with expanded indication for use. Approval was granted for both the transfemoral and transapical approaches. For the transfemoral approach, indications were broadened to include individuals who are at high risk for open surgery. For the transapical approach, approval was granted for individuals who are at high risk for open surgery.

To ensure long-term safety and efficacy of the SAPIENTM Transcatheter Heart Valve System, the FDA also requires annual reports and 5-year follow-up studies investigating durability and quality-of-life outcomes. Additionally, the FDA requires that newly enrolled participants be followed for 5 years post-implant to assess neurological and vascular outcomes. This system is being evaluated for other indications and potential patient populations, as well.

Given both the high-risk nature of procedures involving these catheter interventions and the availability of established alternative treatment options using traditional surgical approaches, several considerations are being recommended for institutions and professional providers planning to implement these new technologies, such as TAVR. Recommendations for performing TAVR were developed with the collaboration of cardiologists and cardiothoracic surgeons from the following specialty societies: the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS). These recommendations were established to guarantee a successful TAVR program that ensures patient safety and demonstrates commitment to excellence by the institution and procedural volume requirements.

Other TAVR devices are currently in development and in clinical trials. The next-generation SAPIENTM XT device (Edwards LifeSciences, Irvine, CA) features a cobalt-chromium alloy frame. Another system in development is the CoreValve Revalving SystemTM (Medtronic, Inc., Minneapolis, MN, USA), which features a porcine pericardial tissue valve mounted in a self-expanding, nitinol-alloy mesh frame. This system uses a transfemoral artery approach and has also been inserted through the subclavian artery. This device, although approved in Europe, has not been approved by the FDA in the United States.

PEER-REVIEWED LITERATURE

The evidence on transcatheter aortic-valve replacement (TAVR) consists of one pivotal randomized controlled trial (RCT) – the PARTNER trial, and several uncontrolled case series. These studies report on one of two patient population for TAVR:

  • Individuals who are high-risk and surgically inoperable candidates
  • Individuals who are high-risk for surgery but still operable candidates

TRANSCATHETER AORTIC VALVE REPLACEMENT FOR INDIVIDUALS WITH AORTIC STENOSIS WHO ARE NOT SUITABLE CANDIDATES FOR OPEN SURGERY

There have been several case series of TAVR, the majority of which have included individuals who are considered high risk and inoperable for surgery. However, the selection of individuals for TAVR has been largely subjective: expert opinion of cardiac surgeons and/or cardiologists has been the main determining factor of individual suitability for the surgery. Consequently, it is difficult to clearly distinguish individuals who are high-risk operable candidates, and, therefore, some overlap may exist.

In 2010, the Agency for Healthcare Research and Quality (AHRQ) reviewed 84 case studies involving 2,375 individuals. Overall, TAVR was successful in 94 percent of individuals, and the aggregated 30-day survival rate was 89 percent across all studies. Adverse event rates were reported in larger case studies, with an estimated 30-day rate of major cardiovascular adverse events and stroke of 8 percent.

The two largest studies included in the AHRQ review reported on 646 individuals treated with the Medtronic CoreValveTM and on 339 individuals treated with the Edwards SAPIENTM valve. The CoreValveTM study by Piazza et al. (2008) used an objective patient selection criteria that included: Logistic EuroScore of greater than or equal to 15 percent, 75 years of age or older, or 65 years of age or older with a condition (condition defined as: liver cirrhosis, pulmonary insufficiency, pulmonary hypertension, previous cardiac surgery, porcelain aorta, recurrent pulmonary emboli, right ventricular insufficiency, previous chest burns or radiation precluding open surgery, or body mass index (BMI) =18kg/m2).

Piazza et al. (2008) reported a procedural success of 97 percent, a 30-day survival of 92 percent, and a 30-day combined rate of death, myocardial infarction (MI), or stroke of 9.3 percent. A study using Edwards SAPIENTM valve by Rodes-Cabou et al. (2010) included a subjective inclusion criteria (relying on the judgment of participating surgeons to determine eligibility for TAVR), and reported a procedural success rate of 93.3 percent, a 30-day mortality of 10.4 percent, and, at a median follow-up of 8 months, a mortality rate of 22.1.

A systematic review by Figulla et al. (2011) included studies that enrolled symptomatic individuals with severe aortic stenosis, had a mean age of 75 years or older, reported on 10 or more individuals, and had a follow-up duration of 12 months or longer. A total of 12 studies met these criteria and were compared to a group of 11 studies that treated severe aortic stenosis with nonsurgical therapy. The procedural success in these studies ranged from 86 percent to 100 percent, and the 30-day mortality ranged from 5.3 percent to 23 percent. The combined mean survival rate at one year was 75.9 percent (95% confidence interval [CI]:73.3-78.4). This 1-year survival rate compared favorably to medical therapy, which was estimated to be 62.4 percent (95% CI: 59.3-65.5).

A case series from Germany on 697 individuals treated with the CoreValveTM reported a procedural success of 98.4 percent, and a 30-day mortality of 12.4 percent. Another large case series from Italy that included 663 individuals treated with the CoreValveTM device reported a procedural success of 98 percent and 15 percent mortality at one year. A study published by Gurvitch et al. in 2011 reported on durability and longer clinical outcomes for up to 3 years. Seventy individuals who underwent TAVR and survived for greater than 30 days were included. Survival at 1, 2, and 3 years was 81 percent, 74 percent, and 61 percent, respectively. One patient (1.5 percent) required reoperation during this time period. The valve area decreased from 1.7 + 0.4 cm2 following the procedure to 1.4 +0.3 cm2 at 3 years. Aortic incompetence was trivial or mild in 84 percent of individuals and did not worsen over time.

The PARTNER trial is a pivotal multicenter RCT of TAVR performed in the US, Canada, and Germany, using the SAPIENTM heart-valve system. In 2010, Leon et al. reported results of the cohort of individuals who were not candidates for open surgery. Individuals were considered not suitable for open surgery if they had a predicted probability of >50 percent for death or a serious irreversible condition at 30 days post-surgery as determined by two surgeon investigators using clinical judgment and the Society of Thoracic Surgery (STS) risk score. The executive committee of the PARTNER trial reviewed all patient selection decisions and approved the classification of individuals as unsuitable for surgery. Of the total 3,105 individuals screened for aortic-valve surgery, 12 percent were included in the cohort of individuals deemed unsuitable for surgery. The primary outcome was death from any cause over the course of the trial (median follow-up 1.6 years); a co-primary endpoint was the composite of time to death from any cause or time to repeat hospitalization related to aortic stenosis or TAVR. Secondary endpoints were cardiovascular mortality, New York Heart Association (NYHA) functional class, the rate of hospitalizations due to aortic stenosis or TAVR, the six-minute walk test, valve performance as measured by echocardiography, and procedural complications (MI, stroke, acute kidney injury, vascular complications, and bleeding).

A total of 358 individuals were randomized to TAVR (performed via the transfemoral approach) or usual care. Standard therapy was determined by the treating clinicians, and included balloon valvuloplasty of the aortic valve in most cases (83.8 percent). A small number of individuals (6.7 percent) underwent open surgical valve replacement despite the high risk, and another 2.2 percent of individuals underwent TAVR at a center outside the US that was not participating in the trial. The mean age of enrolled individuals was 83.2 years, and there were some baseline imbalances in the patient population indicating that the standard therapy group may have had a higher severity of illness. Standardized scores of surgical risk were higher in the standard therapy group. The Logistic EuroSCORE in the standard therapy group compared to the TAVR group was (30.4+19.1 vs. 26.4+17.2, p=0.04) and the Society of Thoracic Surgery (STS) score was (12.1+6.1 vs. 11.2+5.8, p=0.14). Significantly more individuals in the standard therapy group had chronic obstructive pulmonary disease (COPD) (52.5 percent vs. 41.2 percent, p=0.04) and atrial fibrillation (48.8 percent vs. 32.9 percent, p=0.04), and there was a nonsignificant trend for more individuals in the standard therapy group having a lower ejection fraction (51.1 percent vs. 53.9 percent) and frailty, as determined by pre-specified criteria (28.0 percent vs. 18.15 percent).

At 1-year follow-up, death from any cause was lower for the TAVR group (30.7 percent vs. 49.7 percent, p<0.001). This represents a 19 percent absolute risk reduction, a 38.2 percent relative risk reduction, and a number needed to treat of 5.3 to prevent one death over a 1-year follow-up.

Cardiovascular death was lower in the TAVR group (19.6 percent vs. 44.1 percent, p<0.001). The composite of all-cause mortality and repeat hospitalization was reached by 42.5 percent of the individuals in the TAVR group compared with 70.4 percent in the standard therapy group. The percentage of individuals in NYHA Class I or II at 1 year was higher for the TAVR group (74.8 percent vs. 42.0 percent, p<0.001). The authors also reported a significant improvement in the 6-minute walk test for the TAVR group but not the standard group. Subgroup analysis did not report any significant differences in outcomes according to clinical and demographic factors.

Complication rates were higher in TAVR group: stroke or transient ischemic attack (TIA) at 1 year was more than twice as frequent for the TAVR group (10.6 percent vs. 5 percent, p=0.04). Major bleeding and vascular complications occurred in a substantial percent of individuals undergoing TAVR and were significantly higher than the standard therapy group (22.3 percent vs. 11.2 percent, p=0.007; and 32.4 percent vs. 7.3 percent, p=0.001, respectively).

In 2012, Quality of Life (QOL) outcomes were reported by Reynolds et al. for the PARTNER trial. QOL were evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score, the Medical Outcomes study short-form 12 (SF-12), and the EuroQol (EQ-5D). The exact number of participants who completed the QOL measurement was not clearly reported; however, estimates from the graphical representation show that 149-170 individuals in the TAVR group and 138-157 individuals in the medical therapy group completed baseline QOL measurements. At the follow-up time points of 30 days, 6 months, and 12 months, the change in the QOL score was greater for the TAVR group. At 30 days, the mean difference in the KCCQ was 13.3 points (95% CI: 7.6-19.0 p<0.001). This mean difference increased at 6 months to 20.8 points (95% CI: 14.7-27.0, p<0.001) and 26.0 points (95% CI: 18.7-33.3, p<0.001) at 12 months. Similar patterns were also seen in SF-12 and EQ-5D measurements.

The 2-year outcomes of the PARTNER trial, reported mortality at 43.3 percent in TAVR group compared to 68.0 percent in the medical therapy group (Hazard ratio 0.58, 95% CI: 0.36-0.92, p=0.02). Cardiovascular mortality and rate of hospitalization were also lower in the TAVR group compared to standard therapy (31.0 percent vs. 62.4 percent, p<0.001) and (35.0 percent vs. 72.5 percent, p<0.001), respectively.

The PARTNER B trial reported a large decrease in all-cause mortality and cardiovascular mortality at 1 year for TAVR compared to standard therapy. The large decrease in mortality and improved QOL was also reported for the TAVR group at 2-year follow-up. Baseline group differences between the TAVR group and the standard therapy group were present, indicating that the TAVR group may have been healthier. While these differences are unlikely to account for the degree of mortality benefit reported, they may have resulted in an overestimation of the mortality benefit. The TAVR group also reported increased stroke risk, as well as substantial increase in vascular complication and major bleeding. Overall generalizability of this study is also uncertain because patient selection was primarily determined by the judgment of the cardiovascular surgeons and/or cardiologists.

TRANSCATHETER AORTIC VALVE REPLACEMENT FOR INDIVIDUALS WITH AORTIC STENOSIS WHO ARE HIGH-RISK CANDIDATES FOR OPEN SURGERY

The PARTNER trial reported results on individuals who were high-risk for open surgery, but still suitable candidates in June 2011. The inclusion and exclusion criteria were generally the same as for the prior cohort, except that these candidates were classified as high-risk for surgery rather than unsuitable for surgery. A predicted perioperative mortality of >15 percent as determined by a cardiac surgeon and cardiologist was determined to be a high-risk patient. An STS score of >10 was included as a guide for high-risk status, but an STS score threshold was not a required criterion for enrollment. Of the total 3,105 individuals screened for aortic valve surgery, 22.5 percent of these were included in the cohort of individuals deemed high-risk for surgery.

The primary hypothesis was that TAVR was non-inferior to open aortic valve replacement (AVR), using a one-sided non-inferiority boundary of 7.5 percent absolute difference in mortality at 1 year. A total of 699 individuals were randomized to TAVR or usual care. TAVR was performed under general anesthesia using the transfemoral approach if possible (n=492), and through transapical approach (n=207) if the transfemoral approach was not possible. The comparison groups underwent open AVR. The primary outcome was death from any cause at 1-year follow-up and the secondary powered endpoint was non-inferiority at 1 year for the individuals undergoing TAVR by the transfemoral approach. Secondary endpoints were cardiovascular mortality, NYHA function class, re-hospitalizations, the 6-minute walk test, valve performance as measured by echocardiography, and procedural complications (MI, stroke, acute kidney injury, vascular complications, and bleeding). The mean age of enrolled individuals was 83.6 years in the TAVR group and 84.5 years in the open AVR group. Other baseline demographics and clinical characteristics were generally well-balanced, except for a trend toward an increased percentage of individuals in the TAVR group with a creatinine level >2.0 (11.1 percent vs. 7.0 percent, p=0.06).

At 1-year follow-up, death from any cause was 24.2 percent for the TAVR group compared to 26.8 percent for the open AVR group (p=0.44 for difference between groups). The upper limit of the 95% confidence interval (CI) for the difference between groups was a 3.0 percent excess mortality in the TAVR group, which was well within the non-inferiority boundary of 7.5 percent. Thus the criterion of non-inferiority was met, with a p value of 0.001. Results were similar for the subgroup of individuals who underwent TAVR by the transfemoral approach with 22.2 percent mortality in the TAVR group compared with 26.4 percent mortality in the open AVR group (p=0.002 for non inferiority). The secondary outcomes of cardiovascular mortality (14.3 percent vs. 13.0 percent, p=0.63) and rehospitalization (18.2 percent vs. 15.5 percent, p=0.38) were not significantly different for the TAVR versus open AVR groups. The percent of individuals in NYHA Class I or II was similar between groups at 1 year, as was the improvement in the 6-minute walk test. On subgroup analysis, there was a significant effect of gender with women deriving greater benefit than men (p=0.045), and a significant effect for prior coronary artery bypass graft (CABG) with individuals who had not had prior CABG deriving greater benefit in the TAVR group.

Significant differences were observed between groups for certain complications. Stroke or TIA at 1 year was higher for the TAVR group compared to the open AVR group (8.3 percent vs. 4.3 percent, respectively, p=0.04). Vascular complications were higher in TAVR group than open AVR group (18 percent vs. 4.8 percent respectively, p=0.01), as were major vascular complications (11.3 percent vs. 3.5 percent, p=0.01). Major bleeding, however, was more common in the open AVR group than the TAVR group (25.7 percent vs. 14.7 percent, respectively, p=0.01).

Of the 699 individuals in the trial, 628 completed baseline QOL measures. Overall, individuals in both the TAVR and the open AVR groups demonstrated significant improvements in all QOL measures over the 12 months following treatment. Although the TAVR groups reported superior improvement at one month on the KCCQ (mean difference 9.9, 95% CI: 4.9-14.9, p<0.001), this difference was no longer present at 6 months or 12 months. A similar pattern of results was also reported for the SF-12 and EQ-5D measures.

Overall, for high-risk individuals who were eligible for surgical AVR, there were no differences observed between TAVR and open AVR in terms of mortality at 1 year and most major secondary outcomes. The non-inferiority boundaries for this trial included an upper limit of 7.5 percent absolute increase in mortality, but in actuality the reported mortality for the TAVR group was lower than for the open AVR group. QOL was also similar at 1 year between the TAVR and AVR groups. Stroke or TIA were more common in the TAVR group. Other secondary outcomes were similar between groups, except for higher rates of vascular complications in the TAVR group and higher rates of major bleeding in the open surgery group. Generalizability of results is a concern because participant selection relied largely on the judgment of participating surgeons and cardiologists.

In 2012, the FDA broadened patient indications for TAVR to include individuals who are at high risk for surgery, as defined by an STS risk score of >8 percent, or judged by a heart team to have an operative mortality of >15 percent for open surgery.

TRANSCATHETER AORTIC-VALVE REPLACEMENT BY ALTERNATIVE APPROACHES

The majority of individuals treated with TAVR, and all individuals enrolled in the PARTNER B trial, were treated with the transfemoral approach. Other approaches, such as the transapical approach, have been used in individuals with inadequate femoral access. There is a limited amount of evidence comparing outcomes from different approaches. In the PARTNER A trial, 207 individuals underwent TAVR through the transapical approach, and there were no substantial differences in outcomes between the two approaches.

In 2011, Ewe et al. conducted a non-randomized comparative study to compare outcomes for the transfemoral approach to the transapical approach. The authors included 107 consecutive individuals undergoing TAVR, 47 by transfemoral approach and 50 by the transapical approach. The authors reported a decrease in total radiation exposure and fluoroscopy time for the transapical approach. Mortality was not significantly different for the transfemoral versus the transapical approach (11.1 percent vs. 8.5 percent, respectively, p=0.74 at 30 day) and (19.8 percent vs. 14.3 percent, respectively, at 1 year), and vascular complications were more common in the transfemoral group (18 percent vs.5 percent, respectively, p=0.05).

Another non-randomized comparative study by Thomas et al. (2011) reported higher complication rates with the transapical approach. The authors examined data from a European registry of individuals undergoing TAVR by the transfemoral approach (n=463) to individuals undergoing TAVR by the transapical approach (n=575). The authors reported more frequent complications in the transapical group; however, this group may also have been more severely ill as judged by a higher Euro-Qual risk score. A publication from the UK TAVR registry evaluated risk factors for adverse outcomes in 877 TAVR procedures and found lower survival associated with the transapical approach; however, when controlling for demographic and clinical factors, this relationship did not persist.

Overall, there is some evidence comparing various approaches for TAVR, with the highest-quality studies comparing transfemoral approach with transapical approach. Although this evidence is insufficient to form a definite conclusion on the efficacy of various approaches, it suggests that there are no large differences in outcomes between the transfemoral and the transapical approach. There is very little evidence on all other approaches. In 2012, the FDA approved TAVR via the transapical approach for individuals at high-risk for surgery.

TAVR has been used as a “valve-in-valve” treatment for degenerated bio-prosthetic valves and for failed transcatheter valves. However, evidence of this indication consists of small case series and is insufficient to determine whether outcomes are improved compared to alternatives.
Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

COMMERCIAL PRODUCTS ONLY (NON-MEDICARE ADVANTAGE)

Transcatheter aortic-valve replacement (TAVR) for severe aortic stenosis, using an FDA-approved Transcatheter Heart Valve System and performed via transfemoral approach, is considered medically necessary and, therefore, covered when ALL of the following criteria are met:
  • The individual has aortic stenosis with a calcified aortic annulus, as defined by one or more of the following criteria:
      • An aortic valve area of less than 0.8 cm2
      • A mean aortic valve gradient greater than 40 mmHg
      • A jet velocity greater than 4.0 m/sec
  • The individual has New York Heart Association (NYHA) Classification II,III or IV symptoms.
  • Left ventricular ejection fraction greater than 20%.
  • The individual is not an operable candidate for open surgery, as determined by at least two cardiovascular specialists (cardiologist and/or cardiac surgeon); or the individual is an operable candidate but is at high-risk for open surgery (i.e., Society of Thoracic Surgeons predicted operative risk score of greater than or equal to 8%; or a heart team, which includes experienced cardiac surgeon and a cardiologist, has judged the individual
  • to have an expected mortality risk of greater than or equal to 15% for open surgery)
  • The procedure is being performed by a professional provider and at a facility that meets the recommendations for performing TAVR, as set forth in the Credentialing Recommendations for Heart Valve Replacement Procedure, established in collaboration with the following cardiovascular specialty societies: the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS).

Transcatheter aortic-valve replacement (TAVR) for severe aortic stenosis, using an FDA-approved Transcatheter Heart Valve System and performed via transapical approach, is considered medically necessary and, therefore, covered when ALL of the following criteria are met:
  • The individual has aortic stenosis with a calcified aortic annulus, as defined by one or more of the following criteria:
    • An aortic valve area of less than 0.8 cm2
    • A mean aortic valve gradient greater than 40 mmHg
    • A jet velocity greater than 4.0 m/sec
  • The individual has New York Heart Association (NYHA) Classification II, III, or IV symptoms.
  • The individual has a left ventricular ejection fraction greater than 20%
  • The individual is an operable candidate but is at high-risk for open surgery (i.e. Society of Thoracic Surgeons predicted operative risk score of greater than or equal to 8%; or Judged by a heart team, which includes experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of greater than or equal to 15% for open surgery)
  • The procedure is being performed by a professional provider and at a facility that meets the recommendations for performing TAVR, as set forth in the Credentialing Recommendations for Heart Valve Replacement Procedure, established in collaboration with the following cardiovascular specialty societies: the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS).
All other uses for TAVR, including but not limited to: individuals with a degenerated bio-prosthetic valve (“valve-in-valve” implantation), procedures performed via the transaxillary, transilliac, transaortic, or other approaches, are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


MEDICARE ADVANTAGE PRODUCTS

COVERAGE WITH EVIDENCE DEVELOPMENT

For Medicare Advantage members, under Medicare's Coverage with Evidence Development (CED) provision:
    A. TAVR is eligible for coverage consideration for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication for the device and when ALL of the following requirements are met:
    • The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA-approved indication.
    • Two cardiac surgeons have independently examined the patient face-to-face and evaluated the inoperable individual's suitability for open aortic valve replacement (AVR) surgery, and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.
    • The professional and facility providers, meet ALL the requirements as stated in the CMS Decision memo for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430N).

    B. TAVR may be covered by the Medicare Advantage plan for uses not expressly listed as FDA-approved indications when performed within a clinical study that fulfills ALL the requirements as stated in the CMS Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N).
    • Per Medicare's decision memo for TAVR with CED, when performed within a clinical study, uses of Transcatheter Heart Valve System not expressly listed as an FDA-approved indication OR with a Transcatheter Heart Valve System with an investigational device exemption (IDE) designation, are eligible for coverage consideration by the Medicare Advantage plan for routine costs when ALL the requirements under Medicare's CED are met for TAVR. The costs of the device with an investigational device exemption (IDE) category A designation when used in an approved clinical trial is not considered routine and is, therefore, not covered or eligible for reimbursement by the Company.
TAVR is not covered for individuals in whom existing comorbidities would preclude the expected benefit from correction of the aortic stenosis.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

For Medicare Advantage Members, the hospital record must also reflect that all of the requirements set forth in the CMS Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N) are met.
Guidelines

    The New York Heart Association Classification
        1. No symptoms and no limitation in ordinary physical activity, e.g., shortness of breath when walking, climbing stairs etc.
        2. Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
        3. Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g., walking short distances (20–100 m). Comfortable only at rest.
        4. Severe limitations. Experiences symptoms even while at rest. Mostly bedbound individuals
      The Society of Thoracic Surgeons Predicted Operative Risk Score

        The Society of Thoracic Surgeons (STS) predicts the risk of operative mortality and morbidity on the basis of an individual’s demographic and clinical variables, prior to surgery. This risk score is used to categorize the potential surgical candidate per risk percentage

        The 24 variables used to determine this score are: age, sex, height, weight, diabetes, chronic lung/pulmonary disease, peripheral vascular disease, number of previous cardiac operations, previous CABG, previous valve surgery, renal failure, dialysis-dependent renal failure, derum creatinine, hypertension, type of active endocarditis, cerebrovascular accident, timing of recent myocardial infarction, cardiogenic shock, New York Heart Association Classification, inotropic agents, pulmonary artery mean pressure, procedure status, intra-aortic balloon pump timing, mitral valve surgery.

        The STS risk score can be calculated using the short-term risk calculator available on the STS official web page.

      BENEFIT APPLICATION

      COMMERCIAL MEMBERS ONLY (NON-MEDICARE ADVANTAGE)

      Subject to the terms and conditions of the applicable benefit contract, transcatheter aortic-valve replacement (TAVR) for severe aortic stenosis is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

      Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

      MEDICARE ADVANTAGE MEMBERS

      For Medicare Advantage members, transcatheter aortic-valve replacement (TAVR) for severe aortic stenosis is covered under the applicable medical benefit when the requirements listed in this medical policy are met.

      This policy is consistent with Medicare's coverage criteria for Medicare Advantage members.


      US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

      The Edwards SAPIENTM Transcatheter Heart Valve System received a premarket approval by the FDA on November 2, 2011.

      References

      Bonow RO, Carabello BA, Kanu C et al. ACC/AHA 2006 Guidelines for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease); Developed in collaboration with the Society of Cardiovascular Anesthesiologists; Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2006;114(5):e84-231.


      Centers for Medicare & Medicaid Services (CMS). CMS Press: CMS to Cover New Technology for Medicare Patients with Heart Valve Damage. [CMS Web site]. May 1, 2012. Available at:
      http://www.cms.gov/apps/media/press/release.asp?Counter=4355&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&sr. Accessed June 13, 2013.

      Centers for Medicare & Medicaid Services (CMS). National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N).Decision memo. [CMS Web site]. 05/01/2012. Available at:
      http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAAAAA&.
      Accessed June 13, 2013.

      Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 20.32: Transcatheter Aortic Valve Replacement (TAVR). [CMS Web site]. May, 1, 2012. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355&ncdver=1&NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAACAAAAA%3d%3d&. Accessed June 13, 2013

      Coeytaux RR, Williams JW, Jr., Gray RN, et al. Percutaneous heart valve replacement for aortic stenosis: state of the evidence. Ann Intern Med. 2010; 153(5):314-24.

      Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

      Dewey, Todd M, et al. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. Discussion. J Thorac Cardiovasc Surg. 2008;135(1):180-187.

      Dvir D, Webb J, Brecker S, et al. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the Global Valve-in-Valve Registry. Circulation 2012;126(19):2335-44.

      Ewe SH, Delgado V, Ng AC, et al. Outcomes after transcatheter aortic valve implantation: transfemoral versus transapical approach. Ann Thorac Surg. 2011; 92(4):1244-51.

      Figulla L, Neumann A, Figulla HR, et al. Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature. Clin Res Cardiol. 2011; 100(4):265-76.

      Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation. 2005; 111(24):3316-26.

      Genereux P, Kodali SK, Green Pm et al. Incidence and effect of acute kidney injury after transcatheter aortic valve replacement using the New Valve Academic Research Consortium Criteria. Am J Cardiol. 2012;111(1):100-105.

      Gurvitch R, Wood DA, Tay EL, et al. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation. 2010; 122(13):1319-27.

      Holmes DR, Jr., Mack MJ. Transcatheter valve therapy: a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2011; 58(4):445-55.

      Latib A, Ielasi A, Montorfano M et al. Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience. EuroIntervention. 2012; 7(11):1275-84.


      Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-607.

      Lieberman EB, Bashore TM, Hermiller JB, et al. Balloon aortic valvuloplasty in adults: failure of procedure to improve long-term survival. J Am Coll Cardiol. 1995; 26(6):1522-8.

      Lindroos M, Kupari M, Heikkila J, et al. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993; 21(5):1220-5.

      Linke A, Woitek F, Merx MW et al. Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients with Failing Bioprosthetic Aortic Valves. Circ Cardiovasc Interv. 2012; 5(5):689-97.

      Lung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005; 26(24):2714-20.

      Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012; 366(18):1696-704.


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      Coding

      Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

      The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

      In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

      The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

      CPT Procedure Code Number(s)

      0318T, 33361, 33362, 33363, 33364, 33365, 33367, 33368, 33369

      ICD - 9 Procedure Code Number(s)



      ICD - 10 Procedure Code Number(s)

      ICD-10-PCS codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.




      ICD - 9 Diagnosis Code Number(s)

      395.0 Rheumatic aortic stenosis
      395.2 Rheumatic aortic stenosis with insufficiency

      424.1 Aortic valve disorders

      ICD -10 Diagnosis Code Number(s)

      ICD-10-CM codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.

      I06.0 Rheumatic aortic stenosis
      I06.2 Rheumatic aortic stenosis with insufficiency

      I35.0 Nonrheumatic aortic (valve) stenosis
      I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency


      HCPCS Level II Code Number(s)




      Revenue Code Number(s)



      Cross References



      Version Effective Date: 07/03/2013

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