Developing Story: Consent for ICD, Coverage of MitraClip not an Open-and-Shut Case

Don’t count on headlines; reading the fine print is crucial.

Recently I presented a RACuniversity webcast on the changes to the National Coverage Determination (NCD) for automatic implantable cardioverter defibrillators (ICD), the MitraClip, and more. If you missed it, you can still watch it on demand.

There are a couple interesting points related to this I want to share with you.

First, a bit of trivia. Although I will admit I have not read all of the almost 400 NCDs that the Centers for Medicare & Medicaid Services (CMS) has ever published, the prior NCD for an ICD was the only one I had ever seen that specifically required the patient to provide informed consent. That meant if the patient could not provide informed consent, the procedure would not be covered. Note that this is not merely a measure of the ability to sign the consent. The patient had to be able to understand the risks, benefits, and alternatives of the planned procedure, and then sign the consent.

But they took that requirement out. Instead, all patients receiving an ICD for primary prevention must participate in a shared decision-making encounter using an evidence-based tool. But just like providing informed consent, if the patient can’t participate in that shared decision-making discussion, then the procedure is not covered. I expect we will see more requirements for shared decision-making as time goes by.

The other interesting thing I discovered relates to the MitraClip, which is used during a percutaneous procedure to treat severe symptomatic mitral regurgitation in patients who are not candidates for surgical mitral valve repair or replacement. If a patient has a Medicare Advantage plan from UnitedHealthcare (UHC) and he or she meets the strict requirements of the NCD, the MitraClip can be provided. But if that same patient has commercial insurance provided by UHC, they cannot, because UHC’s own coverage analysis has determined that MitraClip is unproven and not medically necessary. According to their policy guide, there is insufficient evidence demonstrating the long-term efficacy of the device.

This clearly demonstrates the frustration that most of you face every single day when trying to figure out which set of rules to use to determine if a patient should be inpatient or observation. The first patient with Medicare will require use of the two-midnight rule, and the next one, with a commercial plan, requires calling the plan to get an authorization for admission based on their proprietary guidelines.

But in this case, it is potentially a life-and-death situation. You could have a scenario involving two patients with exactly the same problem, with a physician recommending the same procedure, with the same insurer paying their claims, but because they have different plans, one can have the procedure, yet the other cannot.

But let me be clear: I am not saying that CMS is correct to provide coverage and UHC’s policy of non-coverage is wrong. UHC, and all insurers, devote a significant amount of time and effort into reviewing new technologies to ensure that each patient is getting care that appropriate and effective. And in many cases, such as with the MitraClip, the answer is less than clear-cut.

Placing a MitraCLip involves threading a tube up from the groin into the heart, creating a hole between the right and left side of the heart (where a hole should not be), then maneuvering a catheter to the mitral valve, catching the valve just right, then placing a tiny clip on the valve leaflets and hopefully reducing the backflow from the valve. While the treated disease itself is severe and potentially life-threatening, there is a lot of room for complications, both short- and long-term, which could make having no MitraClip the wiser choice. In fact, one of the best pieces of wisdom I have received was that “sometimes it is better to just stand there than to do something.”

Medical history is full of new technologies and medications that were rapidly adopted before the long-term efficacy and dangers were known. One need not look any further than the adoption of Xigris for sepsis to find a medication that was rapidly introduced, at a cost of several thousand dollars per dose, but later found to have no benefit.

But if UHC covers the MitraClip for Medicare Advantage patients, why do they not cover it for their other patients? It’s because UHC does not set medical necessity guidelines for Medicare Advantage patients; they are required to offer to Medicare Advantage patients all services available to patients covered for traditional Medicare. In other words, their hands are tied; in fact, I would bet their coverage experts would say that CMS is doing their patients a disservice by covering MitraClip, not because it is expensive, but because it is unproven.

I have often heard that doctors want to treat all patients “the same,” without regard to their payer source. The coverage issue with MitraClip certainly demonstrates that ignoring insurance coverage may place your patient at risk.

Finally, I need to make a correction from that webcast. If you listened, I referred to modifier QR for the ICD placement; that should be modifier Q0. I am going to blame CMS for that one; the links for the active NCD on the web connect to the transmittals that reference QR. But in 2008, CMS actually changed the modifier required for registry reporting.

Even though it is CMS’s fault, I apologize for the error.

Program Note

 Listen to Dr. Hirsch every Monday on RACmonitor’s Monitor Mondays, 10-10:30 a.m. EST.

 

Comment on this article

Facebook
Twitter
LinkedIn

Ronald Hirsch, MD, FACP, ACPA-C, CHCQM, CHRI

Ronald Hirsch, MD, is vice president of the Regulations and Education Group at R1 Physician Advisory Services. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute-care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the Advisory Board of the American College of Physician Advisors, and the National Association of Healthcare Revenue Integrity, a member of the American Case Management Association, and a Fellow of the American College of Physicians. Dr. Hirsch is a member of the RACmonitor editorial board and is regular panelist on Monitor Mondays. The opinions expressed are those of the author and do not necessarily reflect the views, policies, or opinions of R1 RCM, Inc. or R1 Physician Advisory Services (R1 PAS).

Related Stories

Leave a Reply

Please log in to your account to comment on this article.

Featured Webcasts

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

Stop revenue leakage and boost hospital performance by mastering risk adjustment and HCCs. This essential webcast with expert Cheryl Ericson, RN, MS, CCDS, CDIP, will reveal how inaccurate patient acuity documentation leads to lost reimbursements through penalties from poor quality scores. Learn the critical differences between HCCs and traditional CCs/MCCs, adapt your CDI workflows, and ensure accurate payments in Medicare Advantage and value-based care models. Perfect for HIM leaders, coders, and CDI professionals.  Don’t miss this chance to protect your hospital’s revenue and reputation!

May 29, 2025
I050825

Mastering ICD-10-CM Coding for Diabetes and it’s Complications: Avoiding Denials & Ensuring Compliance

Struggling with ICD-10-CM coding for diabetes and complications? This expert-led webcast clarifies complex combination codes, documentation gaps, and sequencing rules to reduce denials and ensure compliance. Dr. Angela Comfort will provide actionable strategies to accurately link diabetes to complications, improve provider documentation, and optimize reimbursement—helping coders, CDI specialists, and HIM leaders minimize audit risks and strengthen revenue integrity. Don’t miss this chance to master diabetes coding with real-world case studies, key takeaways, and live Q&A!

May 8, 2025
2025 Coding Clinic Webcast Series

2025 ICD-10-CM/PCS Coding Clinic Update Webcast Series

Uncover critical guidance. HIM coding expert, Kay Piper, RHIA, CDIP, CCS, provides an interactive review on important information in each of the AHA’s 2025 ICD-10-CM/PCS Quarterly Coding Clinics in easy-to-access on-demand webcasts, available shortly after each official publication.

April 14, 2025

Trending News

Featured Webcasts

The Two-Midnight Rule: New Challenges, Proven Strategies

The Two-Midnight Rule: New Challenges, Proven Strategies

RACmonitor is proud to welcome back Dr. Ronald Hirsch, one of his most requested webcasts. In this highly anticipated session, Dr. Hirsch will break down the complex Two Midnight Rule Medicare regulations, translating them into clear, actionable guidance. He’ll walk you through the basics of the rule, offer expert interpretation, and apply the rule to real-world clinical scenarios—so you leave with greater clarity, confidence, and the tools to ensure compliance.

June 19, 2025
Open Door Forum Webcast Series

Open Door Forum Webcast Series

Bring your questions and join the conversation during this open forum series, live every Wednesday at 10 a.m. EST from June 11–July 30. Hosted by Chuck Buck, these fast-paced 30-minute sessions connect you directly with top healthcare experts tackling today’s most urgent compliance and policy issues.

June 11, 2025
Open Door Forum: The Changing Face of Addiction: Coding, Compliance & Care

Open Door Forum: The Changing Face of Addiction: Coding, Compliance & Care

Substance abuse is everywhere. It’s a complicated diagnosis with wide-ranging implications well beyond acute care. The face of addiction continues to change so it’s important to remember not just the addict but the spectrum of extended victims and the other social determinants and legal ramifications. Join John K. Hall, MD, JD, MBA, FCLM, FRCPC, for a critical Q&A on navigating substance abuse in 2025.  Register today and be a part of the conversation!

July 16, 2025

Trending News

Happy National Doctor’s Day! Learn how to get a complimentary webcast on ‘Decoding Social Admissions’ as a token of our heartfelt appreciation! Click here to learn more →

CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24