MISHC FAQs on the Updated TAVR National Coverage Determination

MISHC remains committed to sustaining Michigan’s structural heart quality collaborative and continuing data collection across the state.

Although the updated NCD changes certain federal registry requirements, MISHC believes that high-quality clinical data, multidisciplinary Heart Team care, registry-based quality collaboration, national benchmarking, and patient-reported outcomes remain essential to improving patient care.

MISHC is working with senior leaders from both the TVT Registry and BCBSM to determine the best path forward. Participating sites and their teams are encouraged to add their voices to these conversations.

Yes. MISHC strongly supports continued participation in the TVT Registry.

The registry provides infrastructure for:

• Tracking clinical and patient-reported outcomes
• Supporting local and statewide quality improvement
• Comparing performance with national benchmarks
• Identifying variation and opportunities for improvement
• Sharing best practices
• Monitoring operator procedural volumes
• Supporting public-reporting and value-based reimbursement programs
• Meeting requirements that continue to apply to other structural heart procedures

Even where CMS does not require one specific registry or data-collection mechanism, MISHC believes continued TVT Registry participation provides important clinical and quality-improvement value.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is an important patient-reported outcome measure that helps clinicians and quality collaboratives determine whether treatment is improving patients’ symptoms, functional status, quality of life, and overall health experience.

From a patient-centered perspective, MISHC strongly values retaining the KCCQ as part of structural heart quality measurement. At the same time, MISHC is eager to hear all perspectives and understand how sites can:

• Support patients effectively
• Collect meaningful patient-centered information
• Reduce unnecessary data-collection burden

Final decisions should reflect input from participating sites, the TVT Registry, BCBSM, and other partners.

No. Blue Cross Blue Shield of Michigan (BCBSM) remains fully committed to MISHC, providing funding to support clinical data abstraction and reporting resources as well as provider value-based reimbursement (VBR) rewards, that remain in place – subject to applicable program requirements.

There is strong support for MISHC across Michigan, grounded in BCBSM’s financial commitment and the operational support provided by the MISHC Coordinating Center.

Specific program terms, eligibility criteria, and payment details remain governed by BCBSM program requirements and related agreements.

Yes. The MISHC Coordinating Center will continue supporting participating sites in the same manner it has for the past decade. Specifically, sites will continue to receive support through:

• Performance and outcomes reporting
• Data review and personalized site audits
• Quality-improvement initiatives
• Collaborative learning
• Identification and sharing of best practices
• Site and coordinator support
• Statewide performance assessment
• Conversations with site teams and leadership

MISHC is happy to speak with site teams and organizational leaders as they consider next steps for sustaining and strengthening structural heart quality at their institutions.

Yes. MISHC will  continue collecting data across Michigan.

At the same time, MISHC, BCBSM, and TVT leaders are exploring sustainable models that:

• Reduce data-entry and administrative burdens
• Support participating-site coordinators
• Preserve clinically meaningful and patient-centered data
• Allow statewide and national benchmarking
• Identify opportunities for improvement
• Support the sharing of best practices
• Produce measurable improvements in patient care and outcomes

Participating sites will be invited to help determine what the next phase of MISHC’s data-collection and quality-improvement model should look like.

No. A change in CMS’s TAVR registry requirements does not eliminate the registry’s broader value or other requirements for participation.

The TVT Registry remains relevant because:

• Mitral transcatheter edge-to-edge repair: The applicable CMS NCD continues to require TVT Registry participation for MTEER.
• Quality improvement: Registry data support hospital-level and statewide quality-improvement work.
• Patient-centered outcomes: Measures such as the KCCQ help assess whether procedures meaningfully improve patients’ health and quality of life.
• National benchmarking: The registry allows participating programs to compare performance against national data.
• Heart Team documentation: Registry-supported processes can help sites document required multidisciplinary evaluation.
• Procedural volumes: Registry data can help track operator volumes.
• Public-reporting transparency: Registry participation may affect transparency credit from *U.S. News & World Report*.
• Value-based reimbursement: Registry participation and data may support VBR arrangements.
• BCBSM support: Blue Cross Blue Shield of Michigan (BCBSM) remains fully committed to MISHC, providing funding to support clinical data abstraction and reporting resources as well as provider value-based reimbursement (VBR) rewards, that remain in place – subject to applicable program requirements.

Yes. MISHC strongly supports preserving the multidisciplinary Heart Team as a foundational component of every TAVR program.

The Heart Team supports:

• Comprehensive patient evaluation
• Appropriate treatment selection
• Consideration of surgical and transcatheter options
• Assessment of patient-specific risks, life expectancy, and treatment goals
• Shared decision-making
• Coordination across specialties
• Consistent documentation of clinical recommendations

MISHC will continue working with sites to support reliable and efficient documentation of CMS-mandated Heart Team evaluation.

Until additional operational guidance is issued, sites should continue following applicable CMS requirements and their current documentation processes.

A consistent record should identify, as applicable:

• Participating Heart Team clinicians and specialties
• Required clinical evaluations
• Relevant diagnostic findings
• Surgical and transcatheter treatment considerations
• The Heart Team’s recommendation and rationale
• Patient-specific risks and eligibility considerations
• Shared decision-making and patient preferences

MISHC may explore ways to standardize this documentation and reduce duplication across clinical records, registry reporting, and quality-improvement activities.

Sites should maintain a reliable method for tracking operator and institutional procedural volumes. Continued registry participation provides a standardized way to support this tracking.

This remains important while CMS evaluates whether longer-term, risk-standardized, patient-centered outcomes could supplement or replace operator-volume criteria.

Under the policy summarized in this National Coverage Analysis Decision Memo, CMS would cover TAVR for Medicare beneficiaries with asymptomatic severe aortic stenosis through Coverage with Evidence Development (CED).

A site furnishing TAVR for this indication would need to participate in a qualifying CED study with an active, contemporaneous comparator that addresses an identified evidence question, such as:

1. Whether TAVR, surgical aortic valve replacement (SAVR), or close surveillance until symptom onset produces better health outcomes—particularly for patients with:
   • Lower surgical risk
   • Longer life expectancy
   • Preserved left ventricular ejection fraction
   • Bicuspid aortic valves

2. The long-term valve reintervention rates for TAVR compared with SAVR and the effect of reinterventions on patient outcomes.

3. Whether longer-term, risk-standardized, patient-centered outcomes can replace volume criteria for TAVR operators.

Sites should consult the final CMS language and applicable study-approval requirements before treating these details as operational guidance.

Under the policy summarized in this National Coverage Analysis Decision Memo, Medicare coverage of TAVR for symptomatic moderate aortic stenosis would require participation in a qualifying CED study with an active, contemporaneous comparator.

The precise study, approval, data, and reporting requirements should be confirmed against the final CMS decision and subsequent implementation guidance.

According to the policy summary, CMS does not require a specific registry or data-collection mechanism for the new CED.

Potential evidence platforms may integrate:

• Registry data
• Electronic health record data
• Claims data
• Clinical study data
• Randomized controlled trial data

CMS has described a registry as an appropriate platform. However, voluntary registry participation alone may not satisfy CED requirements. A qualifying study would still need to meet CMS standards, include an active and contemporaneous comparator, address an approved research question, and obtain any required approval.

According to the policy summary, the new CED framework removes requirements that a registry:

• Continuously enroll all TAVR patients
• Follow patients for at least one year
• Accept all manufactured devices

These changes do not prevent a registry or study from using those features when they are scientifically or operationally appropriate. They also do not reduce MISHC’s support for registry-based quality collaboration, patient-centered outcomes, or national benchmarking.

The updated TAVR framework includes a quality-improvement component involving a comparator. Sites should verify the final language concerning:

• Eligible comparator designs
• Required outcomes
• Reporting obligations
• Study-approval procedures
• Implementation dates
• Whether and how existing registry data may be used

MISHC will continue supporting data-driven quality improvement regardless of the minimum federal reporting requirement.

The National Coverage Analysis for TAVR in aortic regurgitation is open for public comment, based on the information available for this FAQ. It may ultimately include a CED requirement, but that outcome should not be presented as final until CMS issues its decision.

Yes. MISHC is preparing additional formal communications as discussions with senior leaders from the TVT Registry and BCBSM progress. These communications will be shared as decisions and next steps become clearer.

In the meantime, the MISHC Coordinating Center remains available to speak with participating teams and their leadership as they consider how best to foster structural heart quality at their sites.

Participating sites should:

1. Continue meeting all current CMS, payer, and registry requirements.

2. Continue TVT Registry participation.

3. Preserve the multidisciplinary Heart Team as a foundational part of the TAVR program.

4. Maintain consistent Heart Team documentation.                      

5. Maintain reliable operator and institutional volume tracking.

6. Continue supporting MISHC data collection and quality-improvement activities.

7. Continue collecting meaningful patient-centered outcomes, including the KCCQ, under current requirements.

8. Avoid assuming that routine registry participation alone will satisfy a new CED requirement.

9. Monitor final CMS decisions, implementation dates, and study-approval procedures.

10. Share feedback with MISHC about preserving meaningful data collection while reducing site and coordinator burden.

MISHC invites representatives from all participating sites to share their perspectives and help shape the path forward. The voices of site clinicians, coordinators, abstractors, quality leaders, and administrators are important to these discussions.

Participating-site representatives can use this Qualtrics link to join the conversation and help develop the next phase of MISHC’s work in Michigan.

Site input will be especially valuable in identifying:

• The most important clinical and patient-reported measures
• The future role of KCCQ collection
• Sustainable staffing and funding models
• Approaches to Heart Team documentation
• Methods for maintaining national benchmarking
• Ways to support coordinators and clinical teams
• Priorities for future statewide quality initiatives

The American College of Cardiology (ACC), Society of Thoracic Surgeons (STS) and Society for Cardiovascular Angiography & Interventions (SCAI) released the following joint statement on the transcatheter aortic valve replacement (TAVR) national coverage determination finalized by the Centers for Medicare and Medicaid Services (CMS). See here: ACC, STS and SCAI Issue Joint Statement on TAVR National Coverage Determination - American College of Cardiology.