Magnetic Resonance Imaging (MRI)

CMS NCA document | source_status=Closed | review_type=4th Recon | public_comment_open=False | document_id=CAG-00399R4

The Centers for Medicare & Medicaid Services (CMS) is reconsidering our national coverage determination at section 220.2 of the Medicare National Coverage Determinations Manual, specifically the Coverage with Evidence Development (CED) requirement (section 220.2(C)(1)). We determined that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act under certain circumstances. Thus, we will modify our national coverage determination to eliminate the collection of additional information under the Coverage with Evidence Development paradigm under section 1862(a)(1)(E) of the Social Security Act. We summarize these changes below and present our changes fully in Appendix B. We explain the changes in the Analysis section of this NCD decision memo. In general, we: revise the language in section 220.2(C)(1) to remove the contraindication for Medicare coverage of MRI in a beneficiary who has an implanted pacemaker or implantable cardioverter defibrillator; expand coverage to include cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator devices; expand coverage for beneficiaries who have an implanted FDA-approved pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator correspondingly under 220.2(B)(3) of the NCD Manual as a Nationally Covered MRI indication; expand coverage for beneficiaries with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator device that do not have FDA labeling specific for an MRI with certain criteria; remove the Coverage with Evidence Development requirement. We are finalizing changes to Section 220.2(B)(3) of the NCD Manual as described below: B. Nationally Covered MRI and MRA Indications 3. MRI for Patients with an Implanted Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Pacemaker, or Cardiac Resynchronization Therapy Defibrillator An MRI is covered when used according to the FDA labeling in an MRI environment for patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator. Any MRI for patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator that does not have FDA labeling specific to use in an MRI environment is only covered under the following conditions: MRI field strength is 1.5 Tesla using Normal Operating Mode; The implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator system has no fractured, epicardial, or abandoned leads; The facility has implemented a checklist which includes the following: patient assessment is performed to identify the presence of an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator; prior to the MRI scan, benefits and harms of the MRI scan are communicated with the patient or the patient’s delegated decision-maker; prior to the MRI scan, the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is interrogated and programmed appropriately during the scan based on device and patient characteristics; a qualified physician, nurse practitioner or physician assistant with expertise with implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators must directly supervise as defined in 42 CFR § §410.28 and 410.32; patients are observed throughout the MRI scan via visual and voice contact and monitored with equipment to assess vital signs and cardiac rhythm; an advanced cardiac life support provider must be present for the duration of the scan; a discharge plan that includes before being discharged from the hospital/facility, the patient is evaluated and the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is reinterrogated immediately after the MRI scan to detect and correct any abnormalities that might have developed during the MRI. See Appendix B for the NCD manual language. CMS recognizes that the tracking sheet informing the public that we are reconsidering coverage of MRI did not indicate our intention of only reconsidering the coverage with evidence development (CED) subsection (see 220.2(C)(1)) of 220.2 of the NCD Manual. The reason we were intending to only focus on section 220.2(C)(1) of the NCD manual was because there was a number of studies supporting MRI use for the indications in section 220(C)(1). Further, we recognize that there may be limitations to access as well as burden to patients and practitioners with the approved CED studies. We carefully reviewed all of the comments we received following the posting of the tracking sheet and note that several comments requested we expand to indications beyond our current NCD section 220.2(C)(1). We have addressed these comments in the public comment section of this NCA but did not make any changes to any section of the NCD except 220.2(C)(1) of the NCD manual (with corresponding changes to add covered indications in 220.2(B)(3) for alignment).