NCD

The Centers for Medicare and Medical Services (CMS) has determined the following services to be necessary for the treatment of an illness or injury. National Coverage determinations (NCDs) are made through an evidence-based process. See below for a brief description of each NCD. There may be qualifications or restrictions on the procedures below.

For more detailed information on each of the NCDs including restrictions and qualifications click on the link after each NCD or call IEHP DualChoice Member Services at 1-877-273-IEHP (4347) 8 a.m.-8 p.m. (PST), 7 days a week, including holidays, or. TTY/TDD 1-800-718-IEHP (4347).

(Effective: September 28, 2016) 
(Implementation date: October 2, 2017 – for design and coding; January 1, 2018 – for testing and implementation)

Per the recommendation of the United States Preventive Services Task Force (USPSTF), CMS has issued a National Coverage Determination (NCD) which expands coverage to include screening for HBV infection. Previously, HBV screening and re-screening was only covered for pregnant women. 

Hepatitis B Virus (HBV) is transmitted by exposure to bodily fluids. It attacks the liver, causing inflammation. Infected individuals may develop symptoms such as nausea, anorexia, fatigue, fever, and abdominal pain, or may be asymptomatic. An acute HBV infection could progress and lead to life-threatening complications.

The USPTF has found that screening for HBV allows for early intervention which can help decrease disease acquisition, transmission and, through treatment, improve intermediate outcomes for those infected.

What is covered?

Effective for claims with dates of service on or after 09/28/2016, CMS covers screening for HBV infection.

Who is covered?

Medicare beneficiaries who meet either of the following criteria:

• They are considered to be at high-risk for infection; or
• They are pregnant.

Click here for more information on HBV Screenings. By clicking on this link, you will be leaving the IEHP DualChoice website.

((Effective: December 7, 2016) 
(Implementation date: June 27, 2017)

CMS has expanded the PILD for LSS National Coverage Determination (NCD) to now cover beneficiaries that are enrolled in a CMS-approved prospective longitudinal study. Previously, PILD for LSS was covered for beneficiaries enrolled only in a CMS-approved prospective, randomized, controlled clinical trial (RCT) under the Coverage with Evidence Development (CED) paradigm. Now, the NCD will cover PILD for LSS under both RCT and longitudinal studies.

LSS is a narrowing of the spinal canal in the lower back. PILD is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. The procedure removes a portion of the lamina in order to debulk the ligamentum flavum, essentially widening the spinal canal in the affected area.

What is covered?
Effective for claims with dates of service on or after 12/07/16, Medicare will cover PILD under CED for beneficiaries with LSS when provided in an approved clinical study.

Who is covered?
Medicare beneficiaries with LSS who are participating in an approved clinical study.

Click here for more information on PILD for LSS Screenings. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 18, 2017) 
(Implementation date: August 29, 2017 – for MAC local edits; January 2, 2018 – for MCS shared edits)

CMS has issued a National Coverage Determination (NCD) which expands coverage to include leadless pacemakers when procedures are performed in CMS-approved Coverage with Evidence Development (CED) studies. 

Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminates an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. Prior to January 18, 2017, there was no national coverage determination (NCD) in effect.

What is covered?
Effective for claims with dates of service on or after 01/18/17, Medicare will cover leadless pacemakers under CED when procedures are performed in CMS-approved studies.

Who is covered?
Medicare beneficiaries in need of a pacemaker who are participating in an approved clinical study.

Click here for more information on Leadless Pacemakers. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: April 3, 2017) 
(Implementation date: December 18, 2017)

CMS has revised Chapter 1, Section 20.29, Subsection C Topical Application of Oxygen to remove the exclusion of this treatment.  It has been updated that coverage determinations for providing Topical Application of Oxygen for the treatment of chronic wounds can be made by the local Contractors.    

What is covered?
Topical Application of Oxygen for Chronic Wound Care.

Who is covered?
Medicare beneficiaries may be covered with an affirmative Coverage Determination.

Click here for more information on Topical Applications of Oxygen. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: May 25, 2017)
(Implementation Date: July 2, 2018)

CMS has added a new section, Section 20.35, to Chapter 1 entitled Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD).  It has been concluded that high-quality research illustrates the effectiveness of SET over more invasive treatment options and beneficiaries who are suffering from Intermittent Claudication (a common symptom of PAD) are now entitled to an initial treatment.

What is covered?

Eligible beneficiaries are entitled to 36 sessions over a 12-week period after meeting with the physician responsible for PAD treatment and receiving a referral. 

The SET program must:

• Consist of 30-60 minute sessions comprising of therapeutic exercise-training program for PAD;
• Be conducted in a hospital outpatient setting or physician’s office;
• Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and,
• Be under the direct supervision of a physician.

Who is covered?

Medicare beneficiaries who are diagnosed with Symptomatic Peripheral Artery Disease who would benefit from this therapy.

Click here for more information on Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD). By clicking on this link, you will be leaving the IEHP DualChoice website.

Effective: April 10, 2017)
(Implementation Date: December 10, 2018)

CMS has added a new section, Section 220.2, to Chapter 1, Part 4 of the Medicare National Coverage Determinations Manual entitled Magnetic Resonance Imaging (MRI). According to the FDA labeling in an MRI environment, MRI coverage will be provided for beneficiaries under certain conditions.

What is covered?

Effective on or after April 10, 2018, MRI coverage will be provided when used in accordance to the FDA labeling in an MRI environment.

In the instance where there is not FDA labeling specific to use in an MRI environment, coverage is only provided under specific conditions including the following:

• MRI field strength of 1.5 Tesla using Normal Operating Mode
• The Implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), and cardiac resynchronization therapy defibrillator (CRT-D) system has no fractured, epicardial, or abandoned leads
• The facility has implemented a specific checklist

Who is covered?

Medicare beneficiaries with an Implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), and cardiac resynchronization therapy defibrillator (CRT-D).

Click here for more information on MRI Coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: July 31, 2023)
(Implementation Date: July 31, 2023)

What is covered:

An ICD is an electronic device to diagnose and treat life threating Ventricular Tachyarrhythmias (VTs) that has demonstrated improvement in survival rates and reduced cardiac death for certain patients. The Centers of Medicare and Medicaid Services (CMS) will cover claims for effective dates of service on or after February 15, 2018.

Who is covered:

Beneficiaries who meet the coverage criteria, if determined eligible. ICDs will be covered for the following patient indications:

• Personal history of sustained VT or cardiac arrest due to Ventricular Fibrillation (VF) with either:
  • An episode of VT (spontaneous or induced by an electrophysiology (EP) study, not associated with myocardial infraction (MI) (heart attack) and not due to a short term or reversible cause.
  • An episode of cardiac arrest due to VF, not due to a short term or reversible cause.
• Prior MI and measured Left Ventricular Ejection Fraction (LVEF) less than or equal to 0.03 and do not meet the indications not covered below.
• Severe, ischemic, dilated cardiomyopathy without history of sustained VT or cardiac arrest due to VF, and have New York Heart Association (NYHA) Class II or III heart failure with a LVEF less than or equal to 35% and do not meet the indications not covered below.
• Severe, non-ischemic, dilated cardiomyopathy without history of cardiac arrest due to VT or sustained VT, and have NYHA Class II or II heart failure, LVEF less than or equal to 35%, and utilization of optimal medical therapy for at a minimum of three (3) months. Patients must not meet the indications below for this indication. 
• Documented, familial (family history) or genetic disorders with a high risk of life-threating tachyarrhythmias, but not limited to long QT syndrome or hypertrophic cardiomyopathy (thickening muscle of the heart).
• Existing ICD requiring replacement due to battery life, Elective Replacement Indicator (ERI), or malfunction

For patients identified in bullet points 2 through 5, a formal shared decision-making encounter must occur prior to the initial implantation per the NCD.

Who is not covered:

ICDs will not be covered for patient indications:

• For patients meeting the indications in bullet points 2 through 4, patient must not have any of the indications listed in the NCD that would make their treatment non-covered.

Please refer to section 20.4 of the NCD Manual for additional coverage criteria.

Click here for more information on ICD Coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 27, 20) 
(Implementation Date: November 13, 2020)

CMS has updated Chapter 1, Part 2, Section 90.2 of the Medicare National Coverage Determinations Manual to include NGS testing for Germline (inherited) cancer when specific requirements are met and updated criteria for coverage of Somatic (acquired) cancer.

What is covered:

Effective for dates of service on or after January 27, 2020, CMS has determined that NGS, as a diagnostic laboratory test, is reasonable and necessary and covered nationally for patients with germline (inherited) cancer when performed in a CLIA-certified laboratory, when ordered by a treating physician and when specific requirements are met.

Who is covered:

Beneficiaries with Somatic (acquired) cancer or Germline (inherited) cancer when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all the following requirements are met:

For Somatic (acquired) cancer:

• Beneficiary has:
  • either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer and;
  • has not been previously tested with the same test using NGS for the same cancer genetic content and;
  • has decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
• The diagnostic laboratory test using NGS must have:
  • Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic and;
  • 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.

For Germline (inherited) Cancer

• Beneficiary has:
  • ovarian or breast cancer and;
  • a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer and;
  • a risk factor for germline (inherited) breast or ovarian cancer and;
  • not been previously tested with the same germline test using NGS for the same germline genetic content.
• The diagnostic laboratory test using NGS must have:
  • FDA-approval or clearance; and,
  • results provided to the treating physician for management of the patient using a report template to specify treatment options.

Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic test when additional specific criteria are met.

Click here for information on Next Generation Sequencing coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: October 11, 2023) 
(Implementation Date: May 13, 2024) 

What is covered:

Effective on October 11, 2023, CMS has updated section 20.7 of the NCD Manual that provides additional information on coverage regarding Percutaneous Transluminal Angioplasty (PTA). PTA covered in the below instances in order to improve blood flow through the diseased segment of a vessel in order to dilate lesions of peripheral, renal and coronary arteries.  

Who is covered:

The PTA is covered under the following conditions: 

1. Treatment of Atherosclerotic Obstructive Lesions when any of the following are met:
   
   • Treatment of lesions in the lower or upper extremities not including head or neck vessels.
   • Treatment of a single coronary artery for patients who the likely alternative treatment is coronary bypass surgery and meet the characteristics described in this coverage determination.
   • Treatment of renal arteries for patients whom there is a likely inadequate response to a thorough medical management of symptoms and whom surgery is the likely alternative. 
   • Treatment of arteriovenous dialysis fistulas and grafts when performed through either a venous or arterial approach.
2. Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA) – Approved Category B Investigational Device Exemption (IDE) Clinical Trials
3. Concurrent with Carotid Stent Placement in FDA-Approved Post-Approvals Studies 
4. Concurrent with Carotid Stent Placement in Patients at High Risk for Carotid Endarterectomy (CEA)
   • Meet the carotid artery stenosis requirements described in this coverage determination including the assessment and evaluation requirements.
   • The practitioner must include the Member in a formal shared decision-making discussion.
   • Facilities must also establish and maintain both institutional and physician standards to ensure they are supporting a dedicated carotid stent program.
5. Concurrent with Intracranial Stent Placement in FDA-Approved Category B IDE Clinical Trials

Non-Covered Use:

All other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries remain non-covered as the safety and efficacy of these procedures have not been determined.  PTA without stenting that has not been specifically determined as covered by CMS also remains non-covered.

For more information on PTA click here.

(Effective: June 21, 2019)
(Implementation Date: June 12, 2020)

CMS has updated Chapter 1, section 20.32 of the Medicare National Coverage Determinations Manual. The Centers of Medicare and Medicaid Services (CMS) will cover transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) when specific requirements are met.

What is covered:

Effective June 21, 2019, CMS will cover TAVR under CED when the procedure is related to the treatment of symptomatic aortic stenosis and according to the Food and Drug Administration (FDA) approved indication for use with an approved device, or in clinical studies when criteria are met, in addition to the coverage criteria outlined in the NCD Manual.

Who is covered:

This service will be covered when the TAVR is used for the treatment of symptomatic aortic valve stenosis according to the FDA-approved indications and the following conditions are met:

• The procedure and implantation system received FDA premarket approval (PMA) for that system's FDA approved indication
• The patient is under the care of a heart team, which consists of a cardiac surgeon, interventional cardiologist, and various Providers, nurses, and research personnel
• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the related aspects of TAVR
• The hospital where the TAVR is complete must have various qualifications and implemented programs
• The registry shall collect necessary data and have a written analysis plan to address various questions.

This service will be covered when the TAVR is not expressly listed as an FDA-approved indication, but when performed within a clinical study and the following conditions are met:

• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the related aspects of TAVR
• The clinical research study must critically evaluate each patient's quality of life pre- and post-TAVR for a minimum of 1 year, but must also address other various questions
• The clinical study must adhere to all the standards of scientific integrity and relevance to the Medicare population.

Click here for more information on NGS coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: July 2, 2019)
(Implementation Date: June 16, 2020)

CMS has updated Chapter 1, section 20.19 of the Medicare National Coverage Determinations Manual. The Centers of Medicare and Medicaid Services (CMS) will cover Ambulatory Blood Pressure Monitoring (ABPM) when specific requirements are met.

What is covered:

Effective July 2, 2019, CMS will cover Ambulatory Blood Pressure Monitoring (ABPM) when beneficiaries are suspected of having white coat hypertension or masked hypertension in addition to the coverage criteria outlined in the NCD Manual. By clicking on this link, you will be leaving the IEHP DualChoice website.

Who is covered:

This service will be covered when the Ambulatory Blood Pressure Monitoring (ABPM) is used for the diagnosis of hypertension when either there is suspected white coat or masked hypertension and the following conditions are met:

The ABPM device must be:

• Capable of producing standardized plots of BP measurements for 24 hours with daytime and nighttime windows and normal BP bands demarcated;
• Provided to patients with oral and written instructions, and a test run in the physician’s office must be performed; and,
• Interpreted by the treating physician or treating non-physician practitioner.

Coverage of other indications for ABPM is at the discretion of the Medicare Administrative Contractors.

Click here for more information on ambulatory blood pressure monitoring coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 21, 2020)
(Implementation Date: October 5, 2020)

CMS has updated Chapter 1, section 30.3.3 of the Medicare National Coverage Determinations Manual. The Centers of Medicare and Medicaid Services (CMS) will cover acupuncture for chronic low back pain (cLBP) when specific requirements are met.

What is covered:

Effective January 21, 2020, CMS will cover acupuncture for chronic low back pain (cLBP) for up to 12 visits in 90 days and an additional 8 sessions for those beneficiaries that demonstrate improvement, in addition to the coverage criteria outlined in the NCD Manual. By clicking on this link, you will be leaving the IEHP DualChoice website.

Who is covered:

This service will be covered only for beneficiaries diagnosed with chronic Lower Back Pain (cLBP) when the following conditions are met:

• For the purpose of this decision, cLBP is defined as:
  • Lasting 12 weeks or longer;
  • nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc. disease);
  • not associated with surgery; and,
  • not associated with pregnancy.
• An additional 8 sessions will be covered for those patients demonstrating an improvement.
• No more than 20 acupuncture treatments may be administered annually.
• Treatments must be discontinued if the patient is not improving or is regressing.

All types of acupuncture including dry needling for any condition other than cLBP are non-covered by Medicare.

Click here for more information on acupuncture for chronic low back pain coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: February 15. 2020)
(Implementation Date: July 22, 2020)

CMS has updated Chapter 1, section 160.18 of the Medicare National Coverage Determinations Manual. The Centers of Medicare and Medicaid Services (CMS) will cover Vagus Nerve Stimulation (VNS) for treatment-resistant depression when specific requirements are met.

What is covered: 

Effective February 15, 2020, CMS will cover FDA approved Vagus Nerve Stimulation (VNS) devices for treatment-resistant depression through Coverage with Evidence Development (CED) in a CMS approved clinical trial in addition to the coverage criteria outlined in the National Coverage Determination Manual. By clicking on this link, you will be leaving the IEHP DualChoice website.

Who is covered:

Beneficiaries participating in a CMS approved clinical study undergoing Vagus Nerve Stimulation (VNS) for treatment resistant depression and the following requirements are met:

• Treatment is furnished as part of a CMS approved trial through Coverage with Evidence Development (CED).Detailed clinical trial criteria can be found in section 160.18 of the National Coverage Determination Manual.
• The clinical study must address whether VNS treatment improves health outcomes for treatment resistant depression compared to a control group, by answering all research questions listed in 160.18 of the National Coverage Determination Manual.

Patient Criteria:     

• The following criteria must be used to identify a beneficiary demonstrating treatment resistant depression:
  • Beneficiary must be in a major depressive disorder episode for at least two years or have had at least four episodes, including the current episode.
  • Patient’s depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.
  • The patient is experiencing a major depressive episode, as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.
• Patients must maintain a stable medication regimen for at least four weeks before device implantation.
• If patients with bipolar disorder are included, the condition must be carefully characterized.
• Patients must not have:
  • Current or lifetime history of psychotic features in any MDE;
  • Current or lifetime history of schizophrenia or schizoaffective disorder;
  • Current or lifetime history of any other psychotic disorder;
  • Current or lifetime history of rapid cycling bipolar disorder;
  • Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
  • Current suicidal intent; or,
  • Treatment with another investigational device or investigational drugs.
• CMS reviews studies to determine if they meet the criteria listed in Section 160.18 of the National Coverage Determination Manual.
• Nationally Non-Covered Indications
  • VNS is non-covered for the treatment of TRD when furnished outside of a CMS-approved CED study.
  • All other indications of VNS for the treatment of depression are nationally non-covered.
• Patients implanted with a VNS device for TRD may receive a VNS device replacement if it is required due to the end of battery life, or any other device-related malfunction.

Click here for more information on Vagus Nerve Stimulation. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: August 7, 2019)
(Implementation Date: September 20, 2021)

CMS has updated Section 110.24 of the Medicare National Coverage Determinations Manual to include coverage of chimeric antigen receptor (CAR) T-cell therapy when specific requirements are met.

What is covered:

Effective for dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cell expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS) and when specific requirements are met.

Who is covered:

Beneficiaries receiving autologous treatment for cancer with T-cell expressing at least one least one chimeric antigen receptor CAR, when all the following requirements are met:

• Autologous treatment is for cancer with T-cells expressing at least one chimeric antigen receptor (CAR); and
• Treatment is administered at a healthcare facility enrolled in the FDA’s REMS; and
• The therapy is used for a medically accepted indication, which is defined as used for either and FDA approved indication according to the label of that product, or the use is supported in one or more CMS approved compendia.

Non-Covered Use:

The use of non-FDA-approved autologous T-cell expressing at least one CAR is non-covered or when the coverage requirements are not met.

Click here for more information on chimeric antigen receptor (CAR) T-cell therapy coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 19, 2021) 
(Implementation Date: October 4, 2021) 

What is covered:

Effective January 19, 2021, CMS has determined that blood-based biomarker tests are an appropriate colorectal cancer screening test, once every 3 years for Medicare beneficiaries when certain requirements are met. 

Who is covered:

Medicare beneficiaries will have their blood-based colorectal cancer screening test covered once every 3 years when ordered by a treating physician and the following conditions are met:

• The procedure is performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
• The Patient is: 
  • age 50-85 years, and,
  • asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and,
  • average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer)
• The screen test must have all the following:
  • Food and Drug Administration (FDA) market authorization with an indication for colorectal cancer screening; and
  • Proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling.

What is not covered:

• All other indications for colorectal cancer screening not otherwise specific in the regulations or the National Coverage Determination above. This includes:
  • All screenings DNA tests, effective April 28, 2008, through October 8, 2014. Effective for dates of service on or after October 9, 2014, all other screening sDNA tests not otherwise specified above remain nationally non-covered.
  • Screening computed tomographic colonography (CTC), effective May 12, 2009.

Click here for more information on NGS coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: December 1, 2020)
(Implementation Date: July 27, 2021)

What is covered:
Effective for dates of service on or after December 1, 2020, CMS has updated section 20.9.1 of the National Coverage Determination Manual to cover ventricular assist devices (VADs) when received at facilities credentialed by a CMS approved organization and when specific requirements are met.

Who is covered:
Beneficiaries receiving treatment for implanting a ventricular assist device (VAD), when the following requirements are met and:

• The device is used following post-cardiotomy (period following open heart surgery) to support blood circulation.
  • The device must be approved by the Food and Drug Administration (FDA) for this purpose; OR
• They receive a left ventricular device (LVADs) if the device is FDA approved for short- or long-term use for mechanical circulatory support for beneficiaries with heart failure who meet the following requirements:
  • Have New York Heart Association (NYHA) Class IV heart failure; and
  • Have a left ventricular ejection fraction (LVEF) ≤ 25%; and
  • Are inotrope dependent OR have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and meet one of the following:
    • Are on optimal medical management, based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
    • Have advanced heart failure for at least 14 days and are dependent on an intra‐aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.
• Beneficiaries must be managed by a team of medical professionals meeting the minimum requirements in the National Coverage Determination Manual.
• Facilities must be credentialed by a CMS approved organization.

Non-Covered Use:

All other indications for the use of VADs not otherwise listed remain non-covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.

Click here for more information on Ventricular Assist Devices (VADs) coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: April 13, 2021)
(Implementation Date: February 14, 2022)

What is covered:

Effective for dates of service on or after April 13, 2021, CMS has updated section 270.3 of the National Coverage Determination Manual to cover Autologous (obtained from the same person) Platelet-Rich Plasma (PRP) when specific requirements are met.

Who is covered:

Beneficiaries receiving treatment for chronic non-healing diabetic wounds for a duration of 20 weeks, when prepared by a device cleared by the Food and Drug Administration (FDA) for the management of exuding (bleeding, oozing, seeping, etc.) wounds affecting the skin.

Non-Covered Use:

The following uses are considered non-covered:

• Use of autologous Platelet-Derived Growth Factor (PDGF) for treatment of chronic, non-healing, cutaneous (affecting the skin) wounds, and,
• Becaplermin, a non-autologous growth factor for chronic, non-healing, subcutaneous (beneath the skin) wounds, and,
• Autologous Platelet-Rich Plasma (PRP) treatment of acute surgical wounds when applied directly to the close incision, or for splitting or open wounds.

Other:

Coverage for the treatment beyond 20 weeks, or for all other chronic non-healing wounds will be determined by the local Medicare Administrative Contractors (

Click here for more information on Blood-Derived Products for Chronic, Non-Healing Wounds coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: July 31, 2023)
(Implementation Date: July 31, 2023)

What is covered:

Effective for dates of service on or after January 19, 2021, CMS has updated section 20.33 of the National Coverage Determination Manual to cover Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation when specific requirements are met.

Who is covered:

Beneficiaries receiving treatment for Transcatheter Edge-to-Edge Repair (TEER) when either of the following are met:

1. For the treatment of symptomatic moderate to severe mitral regurgitation (MR) (a type of heart valve disease) when the patient still has symptoms, despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) and cardiac resynchronization (treatment to help correct heart rhythm problems) therapy, when appropriate and the following are met:
   1. Treatment is a Food and Drug Administration (FDA) approved indication,
   2. The procedure is used with a mitral valve TEER system that has received premarket approval from the FDA.
   3. The beneficiary is under the care of a heart team meeting the requirements listed in this coverage determination.  
   4. Patient must be evaluated for suitability for repair and must be documented and made available to the other heart team members meeting the requirements of this determination. For patients with functional MR, the cardiologist must document the persistent symptoms in accordance with this coverage determination.
   5. The procedure must be performed by an interventional cardiologist or cardiac surgeon from the heart team in accordance with the requirements in this coverage determination.
      1. All physicians participating in the procedure must have device-specific training by the manufacturer of the device.
   6. The procedure must be performed in a hospital with infrastructure and experience meeting the requirements in this coverage determination.
   7. The heart team must participate in the national registry and track outcomes according to the requirements in this determination.
2. Mitral valve TEERs are covered for other uses not listed as an FDA-approved indication when performed in a clinical study and the requirements listed in this coverage determination are met.  

Non-Covered Use:

The following uses are considered non-covered:

• Treatment for patients with existing co-morbidities that would preclude the benefit from the procedure.
• Treatment for patients with untreated severe aortic stenosis.

Other:

This determination will expire ten years after the effective date if a reconsideration is not made during this time.  Upon expiration, coverage will be determined by the local Medicare Administrative Contractors (MACs).

Click here for more information on Transcatheter Edge-to-Edge Repair [TEER] for Mitral Valve Regurgitation coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: December 15, 2017)
(Implementation Date: January 17, 2022) 

Effective for dates of service on or after December 15, 2017, CMS has updated section 220.6.19 of the National Coverage Determination Manual clarifying there are no nationally covered indications for Positron Emission Tomography NaF-18 (NaF-18 PET).

Non-Covered Use:

Positron Emission Tomography NaF-18 (NaF-18 PET) services to identify bone metastases of cancer provided on or after December 15, 2017, are nationally non-covered.

Other

Use of other PET radiopharmaceutical tracers for cancer may be covered at the discretion of local Medicare Administrative Contractors (MACs), when used in accordance to their Food and Drug Administration (FDA) approval indications.

Click here for more information on Positron Emission Tomography NaF-18 (NaF-18 PET) to Identify Bone Metastasis of Cancer coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

Information on the page is current as of December 28, 2021
H5355_CMC_22_2746205 Accepted

(Effective: September 27, 2021)
(Implementation Date: January 3, 2023)

What is covered:
Effective September 27, 2021, CMS has updated section 240.2 of the National Coverage Determination Manual to cover oxygen therapy and oxygen equipment for in home use of both acute and chronic conditions, short- or long- term, when a patient exhibits hypoxemia. CMS has updated section 240.2 of the National Coverage Determination Manual to amend the period of initial coverage for patients in section D of NCD 240.2 from 120 days to 90 days, to align with the 90-day statutory time period

Who is covered:

Beneficiaries who exhibit hypoxemia (low oxygen in your blood) when ALL (A, B, and C) of the following are met:

A. Hypoxemia is based on results of a clinical test ordered and evaluated by a patient’s treating practitioner meeting either of the following:

    a. A clinical test providing a measurement of the partial pressure of oxygen (PO2) in arterial blood.
        i. PO2 measurements can be obtained via the ear or by pulse oximetry.
        ii. PO2 may be performed by the treating practitioner or by a qualified provider or supplier of laboratory services.
    b. A clinical test providing the measurement of arterial blood gas.
        i. If PO2 and arterial blood gas results are conflicting, the arterial blood gas results are preferred source to determine medical need.

B. The clinical test must be performed at the time of need:
    a. The time of need is indicated when the presumption of oxygen therapy within the home setting will improve the patient’s condition.
        i. For inpatient hospital patient’s, the time of need is within 2 days of discharge.
        ii. For patient’s whose initial prescription for oxygen did not originate during an inpatient hospital stay, the time of need occurs when the treating practitioner identifies signs and symptoms of hypoxemia that can be relieved with at home oxygen therapy.

C. Beneficiary’s diagnosis meets one of the following defined groups below:
    a. Group I:
        i. Arterial PO2 at or below 55 mm Hg or arterial oxygen saturation at or below 88% when tested at rest in breathing room air, or;
        ii. Arterial PO2 at or below 55 mm Hg, or arterial oxygen saturation at or below 88% when tested during sleep for patients that demonstrate an arterial PO2 at or above 56 mmHg, or
        iii. Arterial oxygen saturation at or above 89% when awake;or greater than normal decrease in oxygen level while sleeping represented by a decrease in arterial PO2 more than 10 mmHg or a decrease in arterial oxygen saturation more than 5%.

            a. Patient must also present hypoxemia signs and symptoms such as nocturnal restlessness, insomnia, or impairment of cognitive process.

                1. During these events, oxygen during sleep is the only type of unit that will be covered.
                2. Portable oxygen would not be covered.
        iv. Arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88%, tested during functional performance of the patient or a formal exercise,
                1. For a patient demonstrating arterial PO2 at or above 56 mm Hg, or an arterial oxygen saturation at or above 89%, at rest and during the day.
                2. During these events, supplemental oxygen is provided during exercise, if the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.
    b. Group II:
        i. Patients demonstrating arterial PO2 between 56-59 mm Hg, or who’s arterial blood oxygen saturation is 89%, with any of the following condition:
            1. Dependent edema (gravity related swelling due to excess fluid) suggesting congestive heart failure; or,
            2. Pulmonary hypertension or cor pulmonale (high blood pressure in pulmonary arteries), determined by the measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVFL; or,
            3. Erythrocythemia (increased red blood cells) with a hematocrit greater than 56%.
    c. The Medicare Administrative Contractors (MACs) will review the arterial PO2 levels above and also take into consideration various oxygen measurements that can results from factors such as patient’s age, patients skin pigmentation, altitude level and the patients decreased oxygen carrying capacity.

Non-Covered Use:
The following medical conditions are not covered for oxygen therapy and oxygen equipment in the home setting:

• Angina pectoris (chest pain) in the absence of hypoxemia; or,
• Breathlessness without cor pulmonale or evidence of hypoxemia; or,
• Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities; or,
• Terminal illnesses, unless it affects the patient’s ability to breathe.

Other:
The MAC may determine necessary coverage for in home oxygen therapy for patient’s that do not meet the criteria described above. Initial coverage for patient’s experiencing conditions not described above can be limited to a prescription shorter than 90 days, or less than the numbers of days indicated on the practitioner’s prescription. Oxygen therapy can be renewed by the MAC if deemed medically necessary.

The MAC may also approve the use of portable oxygen systems to beneficiaries who are mobile in home and benefit from of this unit alone, or in conjunction to a stationary oxygen system.

Click here for more information on Home Use of Oxygen coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 1, 2022)
(Implementation Date: July 5, 2022)

What is covered:

Effective for dates of service on or after January 1, 2022, CMS has updated section 180.1 of the National Coverage Determination Manual to cover three hours of administration during one year of Medical Nutrition Therapy (MNT) in patients with a diagnosis of renal disease or diabetes, as defined in 42 CFR 410.130. Coverage for future years is two hours for patients diagnosed with renal disease or diabetes.

Medicare will cover both MNT and Diabetes Outpatient Self-Management Training (DSMT) during initial and subsequent years, if the physician determines treatment is medically necessary and as long as DSMT and MNT are not provided on the same date.

Dieticians and Nutritionist will determine how many units will be administered per day and must meet the requirements of this NCD as well at 42 CFR 410.130 – 410.134. Additional hours of treatment are considered medically necessary if a physician determines there has been a shift in the patients’ medical condition, diagnosis or treatment regimen that requires an adjustment in MNT order or additional hours of care.

Who is covered:

Beneficiaries with either a renal disease or diabetes diagnosis as defined in 42 CFR 410.130.

Click here for more information on Medical Nutrition Therapy (MNT) coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: February 10, 2022)
(Implementation Date: October 3, 2022) 

What is covered:

Effective for claims with dates of service on or after February 10, 2022, CMS will cover, under Medicare Part B, a lung cancer screening counseling and shared decision-making visit. An annual screening for lung cancer with LDCT will be available if specific eligibility criteria are met. 

Prior to the beneficiary’s first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets specific criteria.

Who is covered:

Members must meet all of the following eligibility criteria: 

• 50– 77 years old;
• Asymptomatic (no signs or symptoms of lung cancer);
• Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack =20 cigarettes);
• Current smoker or one who has quit smoking within the last 15 years;
• Receive an order for lung cancer screening with LDCT.

Click here for more information on LDCT coverage. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: April 7, 2022)
(Implementation Date: December 12, 2022) 

What is covered:
Effective on April 7, 2022, CMS has updated section 200.3 of the National Coverage Determination (NCD) Manual to cover Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for treatment of Alzheimer’s Disease (AD) when the coverage criteria below is met. 

Who is covered:
Beneficiaries with Alzheimer’s Disease (AD) may be covered for treatment when the following conditions (A or B) are met: 

1. The treatment is based upon efficacy from a change in surrogate endpoint such as amyloid reduction. The treatment is considered reasonably likely to predict a clinical benefit and is administrated in a randomized controlled trial under an investigational new drug application.
2. The treatment is based upon efficacy from a direct measure of clinical benefit in CMS-approved prospective comparative studies. Study data for CMS-approved prospective comparative studies may be collected in a registry.
   1. For CMS-approved studies, the protocol, including the analysis plan, must meet requirements listed in this NCD.
   2. CMS-approved studies of a monoclonal antibody directed against amyloid approved by the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit must address all of the questions included in section B.4 of this National Coverage Determination.
   3. CMS approved studies must also adhere to the standards of scientific integrity that have been identified in section 5 of this NCD by the Agency for Healthcare Research and Quality (AHRQ).

Click here for more information on study design and rationale requirements. By clicking on this link, you will be leaving the IEHP DualChoice website.

Non-Covered Use:
Monoclonal antibodies directed against amyloid for the treatment of AD provided outside of an FDA-approved randomized controlled trial, CMS-approved studies, or studies supported by the NIH.

Other:
N/A.

Click here for more information on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD). By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: January 1, 2023)
(Implementation Date: November 13, 2023)

What is covered:

Effective on January 1, 2023, CMS has updated section 210.3 of the NCD Manual that provides coverage for colorectal cancer (CRC) screening tests under Medicare Part B.

Who is covered:

Beneficiaries that are at least 45 years of age or older can be screened for the following tests when all Medicare criteria found in this national coverage determination is met:

• Fecal Occult Blood Tests (gFOBT) once every 12 months
• The Cologuard™ – Multi-target Stool DNA (sDNA) Test once every 3 years
• Blood-based Biomarker Tests once every 3 years

Non-Covered Use:
All other indications for colorectal cancer screening not otherwise specified in the Social Security Act, regulations, or the above remain nationally non-covered. Noncoverage specifically includes the following:

1. All screenings DNA tests, effective April 28, 2008, through October 8, 2014. Effective for dates of service on or after October 9, 2014, all other screening sDNA tests not otherwise specified above remain nationally non-covered.
2. Screening computed tomographic colonography (CTC), effective May 12, 2009.

Click here for more information on Ambulatory Electroencephalographic Monitoring and Colorectal Cancer Screening Tests. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: September 26, 2022)
(Implementation Date: March 24, 2023)

What is covered:
Effective on September 26, 2022, CMS has updated section 50.3 of the National Coverage Determination (NCD) Manual that expands coverage on cochlear implants for the treatment of bilateral pre- or post- linguistic, sensorineural, moderate-to-profound hearing loss when the individual demonstrates limited benefit from amplification under Medicare Part B.

Who is covered:
Beneficiaries that demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence recognition. The following criteria must also be met as described in the NCD:

• Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit
• Cognitive ability to use hearing clues and a willingness to undergo an extended program of rehabilitation
• Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the hearing nerve and acoustic areas of the central nervous system
• No indicated risks to surgery that are determined harmful or inadvisable
• The device must be used in accordance with Food and Drug Administration (FDA) approved labeling

Non-Covered Use:
Beneficiaries not meeting all the criteria for cochlear implants are deemed not eligible for Medicare coverage except for FDA-approved clinical trials as described in the NCD.

Click here for more information on Cochlear Implantation. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: July 31, 2023)
(Implementation Date: July 31, 2023)

What is covered:

Effective on July 31, 2023, CMS has issued section 190.1 of the National Coverage Determination (NCD) Manual that provides coverage for histocompatibility testing (compatibility between the tissues of different individuals).  The test matches or types the human leucocyte antigen (HLA), a type of marker on cells in your body.

Who is covered:

The test is considered safe and effective when performed on beneficiaries who meet one of the following criteria:

• In preparation for a kidney transplant.
• In preparation for bone marrow transplantation.
• In preparation for blood platelet transfusions (particularly where multiple infusions are involved).
• Members that are suspected of having ankylosing spondylitis, a type of arthritis that causes inflammation in the joints and ligaments of the spine.

Histocompatibility testing is covered when it is considered reasonable and necessary for beneficiaries that meets one of the first three bullet items listed above.  The test would also be covered for ankylosing spondylitis in cases where other methods of diagnosis would not be appropriate or yield inconclusive findings.

Non-Covered Use:

Indications that do not meet the coverage requirements listed above.

Click here for more information on Histocompatibility Testing. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: May 16, 2023)

(Implementation Date: September 4, 2023)

What is covered:

Effective on September 4, 2023, CMS has issued section 280.16 of the National Coverage Determination (NCD) Manual that provides coverage for power seat elevation equipment on certain power wheelchairs.

Who is covered:

Effective for services performed on or after May 16, 2023, beneficiaries that have undergone a specialty evaluation that confirms their ability to safely operate the seat elevation equipment in the home. The evaluation must be performed by a licensed/certified medical professional such as a Physical Therapist (PT), Occupational Therapist (OT), or other practitioner, who has specific training and experience in rehabilitation wheelchair evaluations. One of the following conditions must also apply:

• The beneficiary can perform weight bearing transfers to/from the power wheelchair while in the home, using either their upper limbs during a non-level (uneven) sitting transfer and/or their lower limbs during a sit to stand transfer. Transfers may be accomplished with or without caregiver assistance and/or the use of assistive equipment (e.g. sliding board, cane, crutch, walker, etc.).
• The beneficiary requires a non-weight bearing transfer (e.g. a dependent transfer) to/from the power wheelchair while in the home. 
  Note: Transfers may be accomplished with or without a floor or mounted lift.
• The beneficiary is able to reach from the power wheelchair to complete one or more mobility related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming and bathing in customary locations within the home. This may be accomplished with or without caregiver assistance and/or the use of assistive equipment.

Non-Covered Use:

Requests that do meet the coverage requirements described above.

Click here for more information on Power Seat Elevation Equipment on Power Wheelchairs. By clicking on this link, you will be leaving the IEHP DualChoice website.

(Effective: March 6, 2024)

(Implementation Date: October 7, 2024)

What is Covered:

Effective on March 6, 2024, CMS has updated section 110.23 of the National Coverage Determination (NCD) Manual that provides Medicare coverage of Stem cell transplantation.  Stem cell transplantation is the process in which stem cells are taken from either a patient’s (autologous) or donor’s (allogenic) bone marrow or peripheral blood for intravenous infusion (administration through a needle or tube into a vein).  Medicare covers stem cell transplantation per the criteria described in this NCD.

Who is Covered:

Stem cell transplantation is covered under the following conditions:

• For Allogeneic Hematopoietic Stem Cell Transplantation (HSCT):
  • For services performed on or after August 1, 1978, HSCT is covered for the treatment of leukemia (a type of cancer of the blood), leukemia in remission, or aplastic anemia (a type of blood disorder) when it is reasonable and necessary, or
  • For services performed on or after June 3, 1985, HSCT is covered for the treatment of Severe Combined Immunodeficiency Disease (SCID) and for the treatment of Wiskott-Aldrich syndrome which are types of disorders of the immune system, or
  • For services performed on or after March 6, 2024, HSCT using bone marrow, peripheral blood or umbilical cord blood stem cell products is covered (a group of disorders caused by blood cells that are poorly formed or don't work properly) who have the prognostic risk scores through the following scoring systems:
    • A International Prognostic Scoring System (IPSS) risk score greater than or equal to 1.5 (Intermediate-2 or high)
    • A International Prognostic Scoring System – Revised (IPSS-R) risk score greater than or equal to 4.5 (high or very high)
    • A Molecular International Prognostic Scoring System (IPSS-M) risk score greater than or equal to 0.5 (high or very high)
• For Autologous Stem Cell Transplantation (AuSCT):  
  • For services performed on or after August 28, 1989, AuSCT is covered under Medicare for patients with the following:
    • Acute leukemia in remission who have a high probability of relapse and who have no Human Leucocyte Antigens (HLA) (a type of molecule found on the surface of most cells in the body) matched, or
    • Resistant Non-Hodgkin's Lymphomas (a type of cancer that starts in white blood cells called lymphocytes) or those presenting with poor prognostic features following an initial response, or
    • Recurrent or refractory neuroblastoma (a type of cancer that forms in the nervous system), or
    • Advanced Hodgkin's disease (a type of cancer that affects the lymphatic system) who have failed conventional therapy and have no HLA-matched donor.
  • For services performed on or after October 1, 2000, AuSCT is covered for Durie-Salmon (a type of clinical staging system) Stage II or III patients that fit the following requirements:
    • Newly diagnosed or responsive multiple myeloma (a type of cancer that forms in the plasma cells) including patients with previously untreated disease, those with at least a partial response to prior chemotherapy (defined as a 50% decrease either in measurable paraprotein [serum and/or urine] or in bone marrow infiltration, sustained for at least 1 month), and those in responsive relapse; and
    • Have adequate cardiac, renal, pulmonary, and hepatic function.
  • For services performed on or after March 15, 2005, AuSCT is covered for services when recognized clinical risk factors are employed to select patients for transplantation, high dose melphalan (HDM) together with AuSCT of any age group with with primary amyloid light chain (AL) amyloidosis (a type of plasma disorder where a type of abnormal light chain protein builds up in the body) who meet the following criteria:
    • Amyloid deposition in 2 or fewer organs; and,
    • Cardiac left ventricular ejection fraction (EF) (a measurement of how much blood the left ventricle of the heart pumps out with each contraction) greater than 45%.

Who is Covered:

• For services performed on or after May 24, 1996, through January 26, 2016, HSCT not covered for multiple myeloma.
• For AuSCT, there is not sufficient data regarding the effectiveness of treatment for the following conditions:
  • Acute Leukemia not in remission;
  • Chronic Granulocytic Leukemia;
  • Solid tumors (other than neuroblastoma);
  • For services prior to October 1, 2000, multiple myeloma;
  • Tandem transplantation (multiple rounds of AuSCT) for patients with multiple myeloma;
  • Non-primary AL Amyloidosis; (effective October 1, 2000), and Primary AL Amyloidosis for patients aged 64 or older (effective October 1, 2000, through March 14, 2005).

Coverage of all other indications for stem cell transplantation not otherwise specified above as covered or non-covered will be made by local Medicare Administrative Contractors.

For a full list of the coverage criteria, please consult the NCD manual here.

Information on the page is current as of June 03, 2024
H8894_DSNP_24_5085779_M_2024_B Accepted