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As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.
The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.
Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).
According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.
Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.
The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.
The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.
Among those:
• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.
• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.
• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.
The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.
The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.
On Twitter @aliciaault
As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.
The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.
Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).
According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.
Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.
The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.
The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.
Among those:
• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.
• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.
• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.
The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.
The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.
On Twitter @aliciaault
As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.
The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.
Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).
According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.
Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.
The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.
The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.
Among those:
• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.
• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.
• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.
The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.
The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.
On Twitter @aliciaault