For reimbursement services support, email us at info@girsinc.com or call us at 901-834-9119.
The Centers for Medicare & Medicaid Services (CMS) proposed updates to coverage policies for artificial hearts and ventricular assist devices (VADs). Artificial hearts and VADs aid in treatment for patients with severe heart failure. Presently artificial hearts are covered by Medicare under the “coverage with evidence development (CED)” model when recipients are a part of a clinical study. Roughly, 6.5 million American adults live with heart disease. The new proposal warrants a patient-centered approach to treating end-stage cardiovascular disease without delaying care. Coverage determinations for artificial hearts would be made by local Medicare Administrative Contractors (MACs).
The VADs coverage criteria in the proposed coverage policies better align with how patients with heart complications are treated and increases physicians’ capabilities to offer the most suitable treatment opportunities to their patients.
The technology can save the lives of certain patients battling heart disease and end-stage heart failure pending heart transplantation. Although Medicare beneficiaries represent a small percentage of artificial hearts recipients, this policy change will improve health outcomes for those Medicare beneficiaries and many others.
Since precise patient selection is important, and the MACs have the expertise to decide which patients will benefit from receiving an artificial heart, based on clinical situations, CMS believe that this proposed decision is within the best interest of Medicare beneficiaries.
CMS is allowing 30 days for comments on the proposed NCD. A final decision will be made and issued no later than October 15, 2020.
Why is this important for #medtech?
Although Medicare beneficiaries represent a small percentage of artificial hearts recipients, this policy change will impact the lives of the 6.6 million American adults living with heart failure. Often private insurers tend to follow Medicare coverage decisions or base their coverage decisions on Medicare’s. Our Payer Advocacy Compass® (PAC) team works closely with payers to help inform them of payer desired outcomes/data and the value story for our clients’ Products. We help the manufacturer to present safety and efficacy data, outcomes from randomized controlled trials (RCTs), Patient-Reported Outcomes (PRO) and Real-World Evidence (RWE) to keep proving the clinical effectiveness and the value proposition for the requisite technology to implement and maintain coverage and payment.
Why Partner with GIRS?
We have extensive experience in the United States and globally for reimbursement work. We have assisted in reviewing National Coverage Decisions, commenting, and developing strategies to reverse national non coverage for a range of technologies. Our work has enabled our clients and their accounts to:
- analyze the impact of payer policy changes for our clients’ Products;
- submit and follow up on redeterminations;
- submit evidence of the medical necessity by communicating payer needs with the providers;
- comment on policy changes on time;
- correct mistakes in payer policies;
- clarify policy language for accounts;
- educate the sales force and accounts in new payer policy language;
- overturn negative coverage decisions;
- lay the foundation of customized payer advocacy strategies based on policy changes.
For more information, email us at info@girsinc.com or call us at 901-834-9119.
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).
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About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.