National coverage determinations

Your source for updates to Medicare-covered services

The Centers for Medicare & Medicaid Services (CMS) makes changes to the services that are covered by Medicare. These changes are updated via National Coverage Determinations.

CMS has issued the following national coverage determinations (NCD):

Effective April 10, 2018: Magnetic Resonance Imaging (MRI)

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after April 10, 2018, Medicare will allow for coverage of MRI for beneficiaries under certain conditions. CMS has determined that 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 under certain circumstances.

Effective Date: March 16, 2018: Next Generation Sequencing (NGS)

[unless otherwise specified, the effective date is the date of service]

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after March 16, 2018, Medicare will allow for coverage of diagnostic laboratory tests that use Next-Generation Sequencing (NGS)* under specified conditions.

CMS will cover such testing under the Medicare program for beneficiaries with recurrent, relapsed, refractory, metastatic cancer, or advanced stages III or IV cancer if the beneficiary has either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician, and decided to seek further cancer treatment (e.g., therapeutic chemotherapy). The test must be ordered by the treating physician, performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, and have all of the following requirements met:

  • Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and
  • An FDA-approved or -cleared indication for use in that patient’s cancer; and
  • Results provided to the treating physician for management of the patient using a report template to specify treatment options.

Additionally, Medicare Administrative Contractors may determine coverage of other diagnostic laboratory tests using NGS for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by the treating physician and the patient has:

  • Either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
  • Either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and
  • Decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer under either national or local coverage criteria.

*NGS consistent with NCD Manual, Publication 100.3, Part 1, Section 90.2

Effective Date: February 15, 2018 - Implantable Cardiac Defibrillators (ICDs)

[unless otherwise specified, the effective date is the date of service]

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after February 15, 2018, CMS will cover Implantable Cardiac Defibrillators (ICDs) for the patient indications listed below:

  1. Patients with a personal history of sustained Ventricular Tachycardia (VT) or cardiac arrest due to Ventricular Fibrillation (VF).
  2. Patients with a prior Myocardial Infarction (MI) and a measured Left Ventricular Ejection Fraction (LVEF) ≤ 0.30.
  3. Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have New York Heart Association (NYHA) Class II or III heart failure, LVEF≤ 35%.
  4. Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF ≤ 35%, and been on optimal medical therapy for at least three (3) months.
  5. Patients with documented familial, or genetic disorders with a high risk of life-threatening tachyarrhytmias (sustained VT or VF), to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.
  6. Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, Elective Replacement Indicator (ERI), or device/lead malfunction.

For indications 2 - 5 above, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Social Security Act (the Act)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. NOTE: The shared decision making encounter may occur at a separate visit.

Exceptions to waiting periods for patients that have had a Coronary Artery Bypass Graft (CABG), or Percutaneous Coronary Intervention (PCI) with angioplasty and/or stenting within the past three (3) months, or had an MI within the past 40 days:

Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in NCD 20.4 for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated;

Replacement of ICDs: Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, ERI, or device/lead malfunction.

For patients that are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor becomes available, is determined by the local Medicare Administrative Contractors (MACs).

All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B Investigational Device Exemption (IDE) trials (42 CFR 405.201).

Effective May 25, 2017: Supervised exercise therapy (SET) for symptomatic peripheral artery disease (PAD)

Effective May 25, 2017, the CMS issued a NCD to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD). Up to 36 sessions over a 12-week period are covered, if all of the following listed components of a SET program are met.

SET Program Must:

  • Consist of sessions lasting 30–60 minutes comprising a therapeutic exercise-training program for PAD in patients with claudication
  • Be conducted in a hospital outpatient setting, or a physician’s office
  • Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD
  • Be under the direct supervision of a physician (as defined in 1861(r)(1), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) who must be trained in both basic and advanced life support techniques
  • A face to face visit with the physician responsible for PAD treatment is required to obtain a referral.
  • SET is not covered for beneficiaries with absolute contraindications to exercise as determined by their primary attending physician.

Effective January 18, 2017: Leadless pacemakers

Effective January 18, 2017, CMS covers leadless pacemakers through coverage with evidence development (CED) and when NCD criteria are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective September 28, 2016: Screening for Hepatitis B Virus (HBV) Infection

Effective September 28, 2016, CMS covers screening for Hepatitis B Virus infection with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests, when NCD eligibility criteria are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective February 8, 2016: Percutaneous left atrial appendage closure (LAAC)

CMS covers percutaneous LAAC for non-valvular atrial fibrillation through CED, when criteria per the NCD are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective July 9, 2015: Human papillomavirus (HPV) testing

CMS covers percutaneous LAAC for non-valvular atrial fibrillation through CED when criteria per the NCD are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective July 29, 2015: Speech Generating Device

Effective July 29, 2015, Medicare Administrative Contractors acting within their respective jurisdictions have discretion to cover or not cover speech generating devices based on their individual reasonable and necessary determinations. In accordance with CMS guidance, Humana will follow the directions of any issued determinations.

Effective February 5, 2015 : Screening for lung cancer with low dose computed tomography (LDCT)

Effective February 5, 2015, CMS covers a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, annual screening for lung cancer with low dose computed tomography (LDCT) under the Medicare program if NCD eligibility criteria are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective October 9, 2014: Colorectal cancer screening tests

CMS has determined that The CologuardTM test is covered once every three years for Medicare beneficiaries that meet specific criteria. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective August 7, 2014: Transcatheter mitral valve repair (TMVR)

CMA covers TMVR for mitral regurgitation when furnished under CED and additional criteria is met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective June 2, 2014: Screening for Hepatitis C Virus (HCV) in adults

CMS will cover screening for HCV with the approved laboratory tests when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet specific conditions. In accordance with CMS guidance, Humana will allow for this service when the specified conditions are met.

Effective February 18, 2014: Cardiac rehabilitation programs for chronic heart failure

CMS has determined that the evidence is sufficient to expand coverage for cardiac rehabilitation services to beneficiaries with stable, chronic heart failure who meet specific criteria. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective January 9, 2014: Percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS)

Effective January 9, 2014, CMS has determined that PILD will be covered when provided to beneficiaries with LSS through CED when criteria per the NCD are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective September 27, 2013: Beta amyloid positron emission tomography (PET) in dementia and neurodegenerative disease

CMS will only allow CED for positron emission tomography (PET) beta amyloid imaging (also referred to as amyloid-beta (Aβ)) when specific conditions are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective August 13, 2013: Single chamber and dual chamber permanent cardiac pacemakers

CMS concluded that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. In accordance with CMS guidance, Humana will allow for this service when the specified conditions are met.

Effective June 11, 2013: Fluorodeoxyglucose (FDG) positron emission tomography (PET) for solid tumors

CMS has ended the CED requirement for FDG PET and PET/CT and PET/MRI for all oncologic indications. In accordance with CMS guidance, Humana will allow for this service without the CED requirement.

Effective May 29, 2013: Aprepitant for chemotherapy induced emesis

CMS has included additional anti-cancer chemotherapeutic agents to the list of agents for which the use of the oral antiemetic 3-drug combination of oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone is deemed reasonable and necessary. In accordance with CMS guidance, Humana will allow for these additional agents.

Effective April 2, 2013: Ocular photodynamic therapy with verteporfin for macular degeneration

CMS will expand coverage of Ocular Photodynamic Therapy with verteporfin for “wet” age-related macular edema. CMS is revising the requirements for testing to permit either optical coherence tomography or fluorescein angiography to assess treatment response. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective March 7, 2013: Positron emission tomography (PET) scans

CMS will allow local Medicare Administrative Contractors (MACs) to determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their FDA approved labeled indications for oncologic imaging. In accordance with CMS guidance, Humana will follow these determinations.

Effective August 2, 2012: Autologous platelet-rich plasma (PRP) for chronic non-healing wounds

CMS will allow coverage for autologous platelet-rich plasma (PRP) only for the treatment of chronic non-healing diabetic, venous and/or pressure wounds when PRP is provided under a clinical research study that meets specific requirements. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective June 27, 2012: Bariatric surgery for treatment of morbid obesity

CMS will allow coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries when specific conditions are met. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective June 8, 2012: Transcutaneous electrical nerve etimulation (TENS) for chronic low back pain (CLBP)

CMS will allow coverage for transcutaneous electrical nerve stimulation (TENS) for chronic low back pain (CLBP) only when the patient is enrolled in an approved clinical study under CED. Claims should be submitted and reimbursed by the Medicare Administrative Contractor.

Effective May 1, 2012: Transcatheter aortic valve teplacement (TAVR)

Transcatheter aortic valve replacement (TAVR) is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a FDA-approved indication and when various conditions outlined in the NCD are met. For indications that are not approved by the FDA, patients must be enrolled in qualifying clinical studies that meet requirements. In accordance with CMS guidance, Humana will allow for this service when the specified criteria are met.

Effective June 21, 2012: Liver transplants

Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of adult liver transplantation for the following malignancies: (1) extrahepatic unresectable cholangiocarcinoma (CCA); (2) liver metastases due to a neuroendocrine tumor (NET); and, (3) hemangioendothelioma (HAE). In accordance with CMS guidance, Humana will follow the directions of any issued determinations.

Effective May 1, 2008: Heart transplants

Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. In accordance with CMS guidance, Humana will allow for this service under the specified criteria.

Effective April 30, 2012: Extracorporeal photopheresis

CMS will cover extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome (BOS) following lung allograft transplantation only when extracorporeal photopheresis is provided under a clinical research study that meets specific requirements to assess the effect of extracorporeal photopheresis for the treatment of BOS following lung allograft transplantation. In accordance with CMS guidance, Humana will now allow for this service under the specified conditions.

Effective November 29, 2011: Obesity therapy

CMS has determined that screening for obesity in older adults along with high intensity behavioral interventions is reasonable and necessary for the prevention or early detection of illness or disability. In accordance with CMS guidance, Humana will now allow for these preventive services.

Effective June 30, 2011: Autologous cellular immunotherapy treatment for prostate cancer

CMS has determined that the use of PROVENGE® for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer is reasonable and necessary. In accordance with CMS guidance, Humana will now allow the use of PROVENGE® for Medicare Advantage patients with these diagnoses.

Effective July 7, 2011: Magnetic resonance imaging (MRI)

CMS has determined that the evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment. In accordance with CMS guidance, Humana will now allow the use of MRIs for Medicare Advantage patients with permanent pacemakers.

Effective October 14, 2011: Screening and behavioral counseling interventions in primary care to reduce alcohol misuse

CMS will now cover an annual alcohol misuse screening and up to four, brief face-to-face behavioral counseling visits in a primary care setting to reduce alcohol misuse. In accordance with CMS guidance, Humana will now allow for these preventive services.

Effective October 14, 2011: Screening for depression in adults

CMS will now cover an annual screening up to 15 minutes for Medicare beneficiaries when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment and follow-up. In accordance with CMS guidance, Humana will now allow a screening as a preventive service

Effective November 8, 2011: Intensive behavioral therapy for cardiovascular disease

CMS now covers intensive behavioral therapy for cardiovascular disease, inclusive of one face-to-face risk reduction visit annually. In accordance with CMS guidance, Humana will now allow for this preventive service.

Effective November 8, 2011: Screening for sexually transmitted infections (STIs) and high intensity behavioral counseling to prevent STIs

The evidence is adequate to conclude that screening for chlamydia, gonorrhea, syphilis and hepatitis B, as well as high intensity behavioral counseling (HIBC) to prevent STIs is reasonable and necessary for the prevention or early detection of an illness or disability. Therefore, CMS will cover screening for these indicated STIs with the appropriate laboratory tests when ordered by the primary care physician or practitioner. In accordance with CMS guidance, Humana will now allow for these preventive services.