CMS Coverage Decision on TAVR Specifies Heart Teams, as Expected

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to a document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS’s) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria include:

• The aortic valve and implantation system used in the procedure has received FDA premarket approval.

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team: "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down the criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together in the intraoperative technical aspects of TAVR.

• The heart team and hospital are participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo. Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials. Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis. The FDA’s Circulatory System Devices Panel will be meeting to evaluate the Sapien valve’s performance in severe aortic stenosis patients at high surgical risk on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.