Knowledge Base Article

Transcatheter Aortic Valve Replacement (TAVR) is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. In 2012, when CMS first published a National Coverage Determination (NCD) for TAVR, it was considered a new technology. Under that current NCD (NCD 20.32), TAVR is covered under Coverage with Evidence Development (CED) according to certain criteria detailed in the NCD. Coverage under CED means that the service is only covered in the context of a clinical trial (such as a national registry or a clinical study). This allows limited coverage for Medicare beneficiaries in a controlled environment while determining the efficacy, risks, and outcomes of the procedure.  Once a new technology or procedure is proven to be safe and effective, CMS may remove the CED requirement and cover the procedure outright within set criteria.

TAVR is not there yet. In a recently released (June 21, 2019) new TAVR Coverage Decision Memo, the requirement for Coverage under Evidence Development remains.

1. TAVR is covered according to CMS criteria when 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 and the heart team and hospital are participating in a prospective, national, audited registry.
2. TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills criteria set forth in the decision memo.

Other requirements that did not change from the current NCD to the new Decision Memo include:

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals;
• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; and
• TAVR must be furnished in a hospital with the appropriate infrastructure.

What did change with the Final Decision Memo and why? First the Why - TAVR now has 7 years of study since the original 2012 NCD and the incidence of and experience with performing the procedure has greatly increased. When the Proposed Decision Memo was released in March of this year, my fellow writer for this newsletter, Beth Cobb, included a table in her article about the memo that looked at the volumes of hospital services coding to MS-DRGs 266 and 267. These DRGs include TAVR and other valve replacements. From 2015 though 2018, the volumes of these DRGs increased around 160% in Alabama and approximately 80-85% in Tennessee and Georgia, respectively.

The major changes in the Final Decision Memo include a change in the pre-procedure patient evaluation requirements and changes in the volumes of services required for the hospital and the heart team to meet criteria for performing the TAVR procedure.

The current TAVR NCD required face-to-face evaluation of the patient’s suitability for TAVR surgery by two cardiac surgeons. The new Decision Memo changes the two cardiac surgeons to a cardiac surgeon and an interventional cardiologist. This makes more sense as these are the two physicians that jointly participate in the intra-operative technical aspects of TAVR. This requirement is addressed in the composition of the heart team as quoted here from the Final Decision Memo:

1. “The heart team includes the following:
2. Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
3. independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
4. documented and made available to the other heart team members the rationale for their clinical judgment.
5. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.”

Both the current NCD and the new Final Decision Memo require certain volumes of procedures for the hospital and the heart team based on whether they have previous TAVR experience or not. Here is a brief summary of the new and old requirements, but be sure to read the new Decision Memo for full details.

Hospitals – no previous TAVR experience

Current NCD (Old requirements)

1. ≥ 50 total AVRs in the previous year prior to TAVR, including ≥ 10 high-risk patients, and;
2. ≥ 2 physicians with cardiac surgery privileges, and;
3. ≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

New Decision Memo (New Requirements)

1. ≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and;
2. ≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
3. ≥ 2 physicians with cardiac surgery privileges, and;
4. ≥ 1 physician with interventional cardiology privileges, and;
5. ≥ 300 percutaneous coronary interventions (PCIs) per year.

Heart Teams – no previous TAVR experience

Current NCD (Old requirements)

1. Cardiovascular surgeon with:
2. ≥ 100 career AVRs including 10 high-risk patients; or,
3. ≥ 25 AVRs in one year; or,
4. ≥ 50 AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation; and,
5. Interventional cardiologist with:
6. Professional experience with 100 structural heart disease procedures lifetime; or,
7. 30 left-sided structural procedures per year of which 60% should be balloon aortic valvuloplasty (BAV). Atrial septal defect and patent foramen ovale closure are not considered left-sided procedures; and,
8. Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers; and,
9. Device-specific training as required by the manufacturer.

New Decision Memo (New Requirements)

1. Cardiovascular surgeon with:
2. ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related; and,
3. Interventional cardiologist with:
4. Professional experience of ≥ 100 career structural heart disease procedures; or, ≥ 30 left-sided structural procedures per year; and,
5. Device-specific training as required by the manufacturer.

Hospital with previous TAVR experience

Current NCD (Old requirements)

1. ≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and,
2. ≥ 2 physicians with cardiac surgery privileges; and,
3. ≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.
4. Heart team - cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:

1. ≥ 20 TAVR procedures in the prior year, or,
2. ≥ 40 TAVR procedures in the prior 2 years.

New Decision Memo (New Requirements)

1. ≥ 50 AVRs (TAVR or SAVR) per year including ≥ 20 TAVR procedures in the prior year; or,
2. ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years; and,
3. ≥ 2 physicians with cardiac surgery privileges; and,
4. ≥ 1 physician with interventional cardiology privileges, and
5. ≥300 percutaneous coronary interventions (PCIs) per year.

What does all of this mean for hospitals? Here is a checklist for hospitals that perform the TAVR procedure:

• The patient must have symptomatic aortic valve stenosis;
• The patient is under the care of a heart team and the heart team's interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR;
• The hospital has the appropriate infrastructure for the procedure;
• Your medical record contains documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluating the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Read the new Decision Memo carefully and make sure you are following all of Medicare’s requirements.

As always with Decision Memos, the requirements are not yet effective until the NCD is updated and implemented. However, NCD revisions generally revert to the effective date of the Decision Memo, which is in this case June 21, 2019. This means hospitals need to know the new requirements now and be preparing now to meet those new requirements.