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Sample Second Level Appeal Letter

Transcatheter Mitral Valve Repair with the MitraClip®

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©2017 Abbott. All rights reserved. AP2939808-US Rev C

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Second Level Appeal Letter

Transcatheter Mitral Valve Repair with the MitraClip®

[Date]

[Health Plan]

[Address]

Attention: [Name of Medical Director]

Member Name: ______________________________ Member ID# _____________________

DX(s) ______________________________________________________________________

Physician ________________________________ Facility ____________________________

Planned Date of Service _______________________________________________________

Pre-auth or Claim denial reference #:_____________________________________________

I am requesting the Second Level Appeal Documentation undergo review by a heart surgeon.

I am writing on behalf of my patient, [patient name] to appeal the [insurance company name] First Level Appeal decision, stated in a letter dated [date] to deny coverage for transcatheter mitral valve repair for the treatment of [his/her] significant symptomatic degenerative mitral regurgitation (DMR) with the MitraClip® Clip Delivery System [CPT code and description]. I request your reconsideration due to the following reasons [address reasons cited for denial].

The Centers for Medicare and Medicaid Services (CMS) finalized a national coverage determination (NCD) for TMVR procedures under Coverage with Evidence Development (CED) that is designed to provide more timely access to breakthrough technologies.[1] This NCD is effective for dates of service beginning on August 7, 2014. The NCD is consistent with the FDA indication for the MitraClip® system.

Transcatheter mitral valve repair with MitraClip® offers a safe and effective alternative option for DMR patients who are considered to be at prohibitive risk for conventional mitral valve surgery, and thereby addresses a significant unmet clinical need for symptomatic patients who otherwise are left to face the dismal prognosis of progressive untreated MR.

I am a cardiologist experienced in mitral valve disease and have determined that the patient requires intervention for [his/her] significant and symptomatic DMR and meets the indicated requirements for treatment with the MitraClip®. [Patient Name] has been evaluated by a heart team who have determined that [he/she] is at prohibitive risk for surgery and requires intervention for his/her significant and symptomatic DMR. Specifically:

1. [Name and title of cardiac surgeon], a cardiac surgeon experienced in mitral valve surgery has determined this patient to be at prohibitive risk to undergo mitral valve surgery. [List surgical risk factors per FDA indication]. Dr. [surgeon last name] has performed [insert number of mitral valve surgeries performed] mitral valve surgeries in the most recent calendar year and is therefore qualified to assess the surgical risk and medical necessity for this patient’s intervention. [Included with this letter is the surgeon’s report documenting the surgical risk factors, STS score, and recommendation for intervention with the MitraClip].

2. [List other physician(s) from the heart team seen by the patient who indicate intervention, e.g. heart failure specialist, echocardiographer], have also determined that the patient requires intervention for [his/her] significant and symptomatic DMR and meets the indicated requirements for treatment with the MitraClip®. [Include description of the specific reports, findings, and recommendations by other physicians who have evaluated the patient].

Clinical History

My patient is an [age]-year old [gender] who has significant symptomatic DMR. [Include detailed description of patient’s condition (ability to perform daily activities, overall condition, etc.). Provide diagnostic description and ICD-9 diagnosis codes and NYHA class and description].

[Describe relevant patient clinical information, including most recent echocardiogram findings of severity of MR, left ventricular dimensions and output, and other diagnostic results. Also include significant comorbidities, such as prior CABG (list year surgery performed, number of vessels grafted), COPD with most recent pulmonary function tests [PFTs], chronic kidney disease with most recent BUN/Cr, etc. to justify why patient is at prohibitive risk for cardiac surgery if not already included above in surgeon’s findings.]

However, these existing comorbidities would not preclude my patient from the expected benefit from reduction of [his/her] MR.

Treatment Rationale

Patients with significant symptomatic MR are at risk for poor quality of life, marked limitation in ability to perform activities of daily living, repeated hospitalizations for heart failure, and increased mortality rates. Onset of MR initially leads to left ventricular dysfunction and impaired hemodynamics, which subsequently results in left ventricular remodeling, which in turn causes worsening MR. Thus a self-perpetuating cycle of MR creating MR is initiated.

While mitral valve surgery is considered the gold standard treatment for significant mitral regurgitation, some patients cannot undergo surgery due to co-morbidities that place them at prohibitive surgical risk. As a result, these patients have limited to no treatment options to reduce their MR. Therefore, the MitraClip® therapy fulfills an unmet need in patients who are considered at prohibitive risk for surgery.

The MitraClip® is a first-of-a-kind transcatheter mitral valve repair device designed to reconstruct the insufficient mitral valve in the beating heart. The FDA labeled indication is as follows:

“The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.”

I urge you to consider the clinical evidence provided below on the MitraClip® therapy from the Prohibitive Surgical Risk DMR cohort of the EVEREST II studies.

Prohibitive Risk DMR MitraClip® Cohort

The Prohibitive Risk DMR clinical cohort data demonstrated major clinical benefits with the MitraClip® therapy including reduction of MR ≤ 2+ which results in reduced hospitalizations, improvements in quality of life, reverse LV remodeling and symptomatic relief in patients with no other therapeutic options. The outcomes are described below and summarized in the following table.

▪ A majority of patients experience MR reduction from 3+/4+ to ≤2+ after the procedure. This improvement is sustained in 83% of patients at 12 months. Results at two years demonstrated that 82.5% of surviving patients remained at ≤2+, which demonstrates there is no evidence of deterioration of MR severity between year 1 and year 2 follow up.

▪ Reduction in MR with the MitraClip® therapy to ≤2+ has been shown to provide significant symptomatic DMR patients with meaningful clinical benefits including reduction of left ventricular volumes.

▪ Patients experienced clinically important improvement in NYHA Functional Class at 12 months; roughly 87% of patients experienced NYHA Class III or Class IV symptoms at baseline, which improved to less than 15% at 12 months.

▪ Despite the elderly and highly co-morbid nature of the population, quality of life scores improved. The improvements in both the Physical Component Summary and Mental Component Summary scores exceeded the 2-3 point threshold generally considered to represent a minimum clinically important difference.

▪ Heart failure hospitalizations were reduced by 73% in the 12 months post-MitraClip® procedure from the 12 months pre-MitraClip® procedure.

Summary of Effectiveness Results

|Outcome |Baseline |12 Month |

|MR Severity 3+/4+ |90.4% |16.7% |

|LVEDV* |125.1 ml |108.5 ml |

|NYHA Class III/IV |86.6% |13.1% |

|SF-36 |33.4 | |

|Physical |46.6 |39.4 |

|Mental | |52.2 |

|Heart Failure Hospitalization Rate (per |12 mos prior to MitraClip® | |

|patient-year) |0.67 |0.18 |

*LVEDV=left ventricular end diastolic volume. (Other LV measures are also reported, but LVEDV is included as a representative LV outcome.)

Furthermore the clinical details of the patient referenced in this letter will be included in the Transcatheter Valvular Therapy (TVT) registry. The TVT Registry was jointly developed by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) in conjunction with CMS and FDA to track patient safety and real-world outcomes related to transcatheter heart valve therapies.

I urge you to overturn this decision, and to provide coverage for this safe and effective therapy for my patient who has no other options for treatment of DMR. I have provided the FDA approval letter and Summary of Safety and Effectiveness Data (SSED) report as supporting evidence. Please contact me if you require additional evidence for this therapy. This appeal decision should be faxed to [your fax #]. If you have any questions please do not hesitate to contact me.

Sincerely,

[Physician Name, Title, and Institution]

Attachments:

• FDA approval letter

• FDA Summary of Safety and Effectiveness Data (SSED)

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[1] NCD for Transcatheter Mitral Valve Repair (20.33)

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Physician Instructions

This sample letter template provides suggestions to assist in writing an Appeal letter for the MitraClip® Clip Delivery System for patients with significant symptomatic mitral regurgitation (MR e" 3+) due to primary abnormalities of the mitral apparatus [degenerative MR] in patients al letter for the MitraClip® Clip Delivery System for patients with significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormalities of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team. It is always the provider’s responsibility to determine the medical necessity of a service for a particular patient, and requirements vary by payer. This sample letter is not meant to be used as a form letter. Physicians should customize the letter based on the patient’s actual medical history, diagnosis and consistent with any specific payer requirements. It is very important to ensure all information provided to payers is accurate and the medical necessity of the procedure is reflected in the patient’s medical record.

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Disclaimer

Hospitals, physicians and other health care providers are responsible for selecting the CPT, HCPCS, or ICD-9-CM codes that most accurately reflect the procedures performed, products used, and patient conditions. Such codes must also be selected and reported on claims forms consistent with the patient's insurer/health care payer's requirements, including the use of any modifiers.

Abbott makes no representation or warranty regarding the completeness, accuracy, or timeliness of information provided here. Payer policies vary from plan to plan, and change over time. Hospitals, physicians and health care providers should check with complete listings of CPT, HCPCS and other codes from authoritative sources, such as the AMA CPT 2017 (Professional Edition), and with CMS national and local Medicare policies from Medicare administrative contractors (MACs) - fiscal intermediaries and carriers, including the policies of the particular patient's health insurance program.

Abbott does not guarantee that the use of this document will result in coverage or payment at any particular level. Abbott will not reimburse hospitals or physicians for claims denied by health insurers/payers.

Abbott Product Information

Any questions or comments about Abbott products or codes and Medicare policies that may be applicable to Abbott products should be directed to the Abbott Reimbursement Hotline (1-800-354-9997). Product information including FDA approved or cleared indications for Abbott products is provided in accordance with Abbott policies and FDA.

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