TAVR program requirements: ≥ 20 procedures/year OR ≥ 40 procedures/2 years; 30 day all-cause mortality ≤ 15%; 30 day neurologic events ≤ 15%;
Full Answer
Does Medicare cover transcatheter aortic valve replacement (TAVR)?
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:
Does CMS cover TAVR?
CMS’ decision comes in response to the continued development of this therapy and streamlines key elements of the original national coverage determination, which went into effect in 2012. CMS will continue to cover TAVR under coverage with evidence development (CED) when furnished according to an FDA-approved indication.
How is TAVR used for aortic stenosis?
Used to treat aortic stenosis, TAVR allows the replacement of the valve via a catheter, avoiding the traditional, sternum-severing open-heart procedures. Under X-ray guidance, the catheter is introduced via an incision in the groin or the arm and threaded through the arteries to the valve.
Is a bioprosthetic aortic valve covered by Medicare?
A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the aortic valve. The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:
Is TAVR procedure covered by Medicare?
The Centers for Medicare & Medicaid Services (CMS) will cover Transcatheter Aortic Valve Replacement (TAVR) for the treatment of symptomatic aortic valve stenosis through Coverage with Evidence Development (CED).
How long is TAVR expected to last for patients?
Medical literature suggests the lifespan of the tissue valves used in surgical aortic valve replacement is typically about 10 to 20 years. Since TAVR valves are made of the same biological tissue, it is expected they will have the same longevity.
What is the average cost of a TAVR procedure?
In the US-based analysis, the mean costs of the initial TAVR procedure and hospitalization were $42,806 and $78,542, respectively.
Is TAVR considered major surgery?
Is TAVR a Major Surgery? It is not! TAVR is a less invasive procedure than open-heart surgery that involves inserting a catheter into small incisions in the large artery of your leg called the femoral artery.
What is the life expectancy of someone with aortic stenosis?
Without treatment, a person's life expectancy with aortic stenosis after symptoms develop is 1–3 years. Around 50–68% of symptomatic people die within 2 years. Often, they die suddenly. However, aortic valve replacement surgery significantly increases life expectancy.
How many times can a TAVR be replaced?
The TAVR valve is a biological tissue valve made from cow or pig heart tissue. Because the procedure is relatively new, doctors are not sure how long a replaced TAVR valve will last. Research suggests the valve may last up to 10 years. If the valve were to fail, our doctors can replace it.
What is the success rate of TAVR?
These results are similar to Deeb et al24 where post-operative outcomes of TAVR valves were compared to SAVR valves; the 3-year all-cause mortality rate for TAVR valves was 32.9%, with a corresponding survival rate of 67.1%.
Does insurance cover valve replacement?
Valve replacement surgery typically is covered by health insurance.
How long does it take to do a TAVR procedure?
A TAVR procedure takes about 90 minutes to complete, whereas open heart surgery typically takes 4-to-6 hours. With TAVR, patients recover faster than they would after a traditional open-heart valve replacement.
How long does TAVR last in elderly?
Due to the mentioned hemodynamic and functional effects of TAVI, the early and midterm survival in patients with AS has significantly improved as shown in Moat, et al. study, who reported life expectancy rates of 92.9%, 78.6% and 73.7% at 30 days, 1 year and 2 years after TAVI, respectively.
Who is not a candidate for TAVR surgery?
For TAVR to be recommended, the evaluation must confirm the following: You have aortic stenosis that is severe in nature and is causing symptoms. You are not a candidate for surgical aortic valve replacement or you're at high risk for surgery and likely would benefit from TAVR therapy.
What is the most common complication of TAVR?
Conduction abnormalities requiring permanent pacemaker (PPM) implantation and development of new left bundle branch block (LBBB) remain the most common TAVR complications.
Decision Summary
The Centers for Medicare & Medicaid Services (CMS) proposes that coverage for TAVR be approved under Coverage with Evidence Development (CED) only for the following conditions and as specified below:
Proposed Decision Memo
The Centers for Medicare & Medicaid Services (CMS) proposes that coverage for TAVR be approved under Coverage with Evidence Development (CED) only for the following conditions and as specified below:
Bibliography
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM264205.pdf. (FDA Clinical Review of P100041)
Description Information
Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
Transmittal Information
9/2012 - Transmittal 145, dated August 3, 2012, is being rescinded and replaced by Transmittal 147, dated September 24, 2012, to include revisions to language in the “Summary of Changes” and clarification to the “Policy Section” of the business requirements for the Pub 100-03 and Pub 100-04 documents. All other information remains the same.
National Coverage Analyses (NCAs)
This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.
What is a TAVR catheter?
In the TAVR procedure, a long, thin tube called a catheter is inserted through an artery in your groin or small incision in your neck or chest. The catheter is used to guide a new heart valve to the area of the aortic valve.
Who approves aortic valve replacement?
The replacement aortic valve and system used to implant it must be approved by the FDA. You must be under the care of a heart team both before and after surgery. The heart team should be made up of different medical professionals, including an interventional cardiologist and a cardiac surgeon.
How is aortic stenosis treated?
Traditionally, severe aortic stenosis was treated with an invasive open-heart surgery. But not everyone could go through open-heart surgery safely. At first, TAVR was approved only to treat patients who were inoperable. But recently, the Food and Drug Administration (FDA) approved TAVR to treat anyone with severe, symptomatic aortic stenosis. In the TAVR procedure, a long, thin tube called a catheter is inserted through an artery in your groin or small incision in your neck or chest. The catheter is used to guide a new heart valve to the area of the aortic valve. Once properly situated, the new valve expands over the diseased valve and begins to function in its place.
Does Medicare cover TAVR?
Medicare covers transcatheter aortic valve replacement (TAVR), a minimally invasive procedure to repair a narrowed aortic valve, as long as certain criteria are met.
When was the Medcac decision made?
Today’s decision was made in response to a formal request and is consistent with recommendations from a meeting of the MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) on July 25, 2018.
Does CMS cover TAVR?
CMS will continue to cover TAVR under coverage with evidence development (CED) when furnished according to an FDA-approved indication. However, CMS is updating the coverage criteria for hospitals and physicians to begin or maintain a TAVR program.
How many TAVRs are required for a hospital?
The facility and physicians must fulfill requirements if adopting TAVR for the first time or if experienced in the technique. Hospitals must perform at least 50 TAVRs and more than 300 percutaneous coronary interventions per year.
What is a TAVR coding?
Coding TAVR is complex, since it’s an intravenous procedure relying on radiology. Medical necessity is key to Medicare reimbursement, and the patient will no doubt be run through a gamut of tests, such as an echocardiogram, CT scan, angiogram, or electrocardiogram. The patient must be in a heart program, and the decision to perform a TAVR isn’t quick. Once confirmed, aortic stenosis is easy to find in ICD-10-CM.#N#Be sure to correctly note the families of arteries through which the catheters are routed. TAVR cardiovascular access and delivery procedures are reported with CPT 33361-33366 with the appropriate add-on codes for bypass (33367-33369).
How does a TAVR procedure work?
Used to treat aortic stenosis, TAVR allows the replacement of the valve via a catheter, avoiding the traditional, sternum-severing open-heart procedures.# N#Under X-ray guidance, the catheter is introduced via an incision in the groin or the arm and threaded through the arteries to the valve. A balloon is inflated to reopen the valve, and a TAVR bioprosthetic valve is placed and deployed. The physician removes the catheter.#N#While less traumatic than the open procedure, TAVR carries its share of risks. The qualifications of the physicians who perform and the patients who benefit from the procedure have been closely watched by CMS and professional societies, with a National Coverage Decision (NCD) released in 2012. This is now updated for the 150+ hospitals performing TAVR.
What are the requirements for TAVR?
The facility and physicians must fulfill requirements if adopting TAVR for the first time or if experienced in the technique. Hospitals must perform at least 50 TAVRs and more than 300 percutaneous coronary interventions per year.#N#They must participate in a prospect, nation, audited registry that follows TAVR patients for at least a year and monitors: 1 Stroke 2 All-cause mortality 3 Transient Ischemic Attacks (TIAs) 4 Major vascular events 5 Acute kidney injury 6 Repeat aortic valve procedures 7 New permanent pacemaker implantation 8 Quality of Life (QoL)
Is TAVR still a clinical trial?
However, it is still consider a clinical trial because of its relatively recent development. CMS said it will continue to cover TAVR under coverage with evidence development (CED) when furnished according to an FDA-approved indication.
What is the benefit period for Medicare?
benefit period. The way that Original Medicare measures your use of hospital and skilled nursing facility (SNF) services. A benefit period begins the day you're admitted as an inpatient in a hospital or SNF. The benefit period ends when you haven't gotten any inpatient hospital care (or skilled care in a SNF) for 60 days in a row.
How long does it take to get into an inpatient rehab facility?
You’re admitted to an inpatient rehabilitation facility within 60 days of being discharged from a hospital.
What is part A in rehabilitation?
Inpatient rehabilitation care. Part A covers inpatient hospital stays, care in a skilled nursing facility, hospice care, and some home health care. Health care services or supplies needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.
Does Medicare cover private duty nursing?
Medicare doesn’t cover: Private duty nursing. A phone or television in your room. Personal items, like toothpaste, socks, or razors (except when a hospital provides them as part of your hospital admission pack). A private room, unless medically necessary.
Does Medicare cover outpatient care?
Medicare Part B (Medical Insurance) Part B covers certain doctors' services, outpatient care, medical supplies, and preventive services.
