CMS finalizes coverage requirements for TAVR

CMS issued the final version of its decision memo outlining requirements that must be met for coverage of transcatheter aortic valve replacement procedures, including the elimination of the requirement for evaluation by two surgeons before the procedure.

As Cardiology Today’s Intervention previously reported, the requirement for two surgeons to sign off before a TAVR procedure was controversial, with some experts saying it was a barrier to patients with severe aortic stenosis getting prompt treatment.

Coverage requirements

According to the memo, TAVR procedures will be covered if they meet the following criteria:

  • use of an FDA-approved TAVR system;
  • care of the patient by a heart team, including a cardiac surgeon and interventional cardiologist who are experienced with treating aortic stenosis;
  • joint participation by the cardiac surgeon and interventional cardiologist in the intraoperative technical aspects of TAVR;
  • performance of the procedure in a hospital with appropriate infrastructure, including on-site heart valve surgery and interventional cardiology programs, a postprocedure intensive care facility and appropriate volume requirements; and
  • participation by the heart team and hospital in a national audited registry that collects all necessary data and has an executable analysis plan.

Coverage will be provided for all FDA-approved indications, as well as off-label procedures that are performed within a clinical study that fulfills certain requirements, according to the memo.

The memo outlined the volume requirements for hospitals that have an existing TAVR program and ones that do not.

Praise from industry

Manufacturers of TAVR systems issued statements praising the revised policy.

CMS issued the final version of its decision memo outlining requirements that must be met for coverage of transcatheter aortic valve replacement procedures, including the elimination of the requirement for evaluation by two surgeons before the procedure.
Source: Adobe Stock

“We commend CMS on its thoughtful approach toward updating the TAVR policy,” Edwards Lifesciences, which makes the Sapien family of balloon-expandable TAVR valves, stated in a press release. “Throughout the [National Coverage Decision] process, Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them. Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all. Many of the core elements of the updated [National Coverage Decision] better reflect today’s practices in the treatment of patients with severe [aortic stenosis], the needs of those patients and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe [aortic stenosis]. We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S., which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development. We look forward to continuing to engage with all of the stakeholders around the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease.”

“Today’s decision underscores the importance of high-quality evidence in shaping coverage policy and beneficiary access to life-saving therapies,” Medtronic, which makes the CoreValve family of self-expanding TAVR systems, stated in a release. “Medtronic supports the updated TAVR [National Coverage Decision] and believes the new coverage policy allows for appropriate patient access to TAVR — especially for patients in rural communities — while still maintaining rigorous requirements for centers and operators providing the therapy. Medtronic has been an active participant over the past year during the National Coverage Analysis and its public commenting periods and provided several recommendations to support patients continuing to have sufficient access to TAVR therapy. We are pleased to see that today's decision is consistent with our position.”

 

CMS issued the final version of its decision memo outlining requirements that must be met for coverage of transcatheter aortic valve replacement procedures, including the elimination of the requirement for evaluation by two surgeons before the procedure.

As Cardiology Today’s Intervention previously reported, the requirement for two surgeons to sign off before a TAVR procedure was controversial, with some experts saying it was a barrier to patients with severe aortic stenosis getting prompt treatment.

Coverage requirements

According to the memo, TAVR procedures will be covered if they meet the following criteria:

  • use of an FDA-approved TAVR system;
  • care of the patient by a heart team, including a cardiac surgeon and interventional cardiologist who are experienced with treating aortic stenosis;
  • joint participation by the cardiac surgeon and interventional cardiologist in the intraoperative technical aspects of TAVR;
  • performance of the procedure in a hospital with appropriate infrastructure, including on-site heart valve surgery and interventional cardiology programs, a postprocedure intensive care facility and appropriate volume requirements; and
  • participation by the heart team and hospital in a national audited registry that collects all necessary data and has an executable analysis plan.

Coverage will be provided for all FDA-approved indications, as well as off-label procedures that are performed within a clinical study that fulfills certain requirements, according to the memo.

The memo outlined the volume requirements for hospitals that have an existing TAVR program and ones that do not.

Praise from industry

Manufacturers of TAVR systems issued statements praising the revised policy.

CMS issued the final version of its decision memo outlining requirements that must be met for coverage of transcatheter aortic valve replacement procedures, including the elimination of the requirement for evaluation by two surgeons before the procedure.
Source: Adobe Stock

“We commend CMS on its thoughtful approach toward updating the TAVR policy,” Edwards Lifesciences, which makes the Sapien family of balloon-expandable TAVR valves, stated in a press release. “Throughout the [National Coverage Decision] process, Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them. Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all. Many of the core elements of the updated [National Coverage Decision] better reflect today’s practices in the treatment of patients with severe [aortic stenosis], the needs of those patients and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe [aortic stenosis]. We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S., which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development. We look forward to continuing to engage with all of the stakeholders around the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease.”

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“Today’s decision underscores the importance of high-quality evidence in shaping coverage policy and beneficiary access to life-saving therapies,” Medtronic, which makes the CoreValve family of self-expanding TAVR systems, stated in a release. “Medtronic supports the updated TAVR [National Coverage Decision] and believes the new coverage policy allows for appropriate patient access to TAVR — especially for patients in rural communities — while still maintaining rigorous requirements for centers and operators providing the therapy. Medtronic has been an active participant over the past year during the National Coverage Analysis and its public commenting periods and provided several recommendations to support patients continuing to have sufficient access to TAVR therapy. We are pleased to see that today's decision is consistent with our position.”