National Coverage Determination

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) 8:00 a.m.-8:00 p.m. (PST), 7 days a week, including holidays. TTY/TDD users should call 1-800-718-4347

1. Screening for Cervical Cancer with Human Papillomavirus (HPV) Testing  
(Effective: July 9, 2015)
(Implementation date: March 7, 2016)

CMS has issued a National Coverage Determination (NCD) and concluded that evidence is sufficient to add screening for cervical cancer with Human Papillomavirus (HPV) co-testing under specified conditions.

What is covered:

Effective for claims with dates of service on or after 06/09/2015, CMS covers HPV testing once every five years as a preventive service for Medicare members who meet the criteria outlined below.

Who is covered:

This NCD covers asymptomatic Medicare beneficiaries aged 30-65 years of age. For more information on Screening for Cervical Cancer with HPV click here.

2. Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes  
(Effective: January 27, 2016)
(Implementation date: October 3, 2016)

CMS has issued a National Coverage Determination (NCD) which expands coverage to include allogenic hematopoietic stem cell transplantation (HSCT) under specified conditions. 

Allogeneic HSCT is a procedure in which a portion of a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion to help restore function in recipients.

What is covered:
Effective for claims with dates of service on or after 01/27/2016, CMS covers Allogenic hematopoietic stem cell transplantation (HSCT) for treatment of Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease as long as it is provided in the context of a Medicare-approved clinical study that meets the specific criteria under the Coverage with Evidence Development (CED) paradigm.

Who is covered:
Medicare beneficiaries with a diagnosis for either Multiple Myeloma, Myelofibrosis, or Sickle Cell Disease, who are also participating in an approved clinical study.

For more information on hematopoietic stem cell transplantation (HSCT) for treatment of Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease click here.

3. Percutaneous Left Atrial Appendage Closure (LAAC)
 
(Effective: February 8, 2016)
(Implementation date: October 3, 2016.)

CMS has issued a National Coverage Determination (NCD) which expands coverage to include percutaneous left atrial appendage closure (LAAC) under specified conditions.

Percutaneous LAAC is a strategy to reduce the risk of stroke by closing the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (NVAF) using a percutaneously implanted device.

What is covered:

Effective for claims with dates of service on or after 02/08/2016, CMS covers percutaneous LAAC for treatment of NVAF under the Coverage with Evidence Development (CED) paradigm.

Who is covered:

  • Medicare beneficiaries with NVAF, who also meet the following criteria:
  • A CHADS2 score greater than or equal to 2, or a CHA2DS2-VASc score greater than or equal to 3.
  • A documented, formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC.
  • A suitability for short-term warfarin but deemed unable to take long-term oral anticoagulation following the conclusion of shared decision making.
  • Under the care of a cohesive multidisciplinary team of medical professionals.

For more information on percutaneous LAAC for treatment of NVAF click here.

4. Screening for Hepatitis B Virus (HBV) Infection
(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 rescreening 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.
For more information on HBV screenings click here.  

5.
Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)
(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.

For more information on PILD for LSS screenings click here.

6. Leadless Pacemakers  
(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.

For more information on leadless pacemakers click here.

7. Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen)  
(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.

For more information on Topical Applications of Oxygen click here.

8. Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

(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.

For more information on Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) click here.

9. Magnetic Resonance Imaging (MRI)
(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).

For more information on MRI Coverage click here.

IEHP DualChoice Cal MediConnect Plan (Medicare-Medicaid Plan) is a Health Plan that contracts with both Medicare and Medi-Cal to provide benefits of both programs to enrollees. Limitations, copays and restrictions may apply. Benefits and copayments may change on January 1 of each year. The List of Covered Drugs and pharmacy and provider networks may change throughout the year. We will send you a notice before we make a change that affects you. For more information, call IEHP DualChoice Member Services or read the IEHP DualChoice Member Handbook.

10. Implantable Cardiac Defibrillators (ICDs)

(Effective: February 15, 2018)
(Implementation Date: February 26, 2019)

CMS has updated Chapter 1, Part 1, Section 20.4 of the Medicare National Coverage Determinations Manual providing additional coverage criteria for Implantable Cardiac Defibrillators (ICD) for Ventricular Tachyarrhythmias (VTs).

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)
  • Prior Myocardial Infarction (MI) and measured Left Ventricular Ejection Fraction (LVEF) less than or equal to .03
  • 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%
  • Severe, non-ischemic, dilated cardiomyopathy without history of cardiac arrest or sustained VT, NYHA Class II or II heart failure, LVEF less than or equal for 35%, and utilization of optimal medical therapy for at a minimum of three (3) months
  • Documented, familial or genetic disorders with a high risk of life-threating tachyarrhythmias, but not limited to long QT syndrome or hypertrophic cardiomyopathy
  • Existing ICD requiring replacement due to battery life, Elective Replacement Indicator (ERI), or malfunction

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

For more information on ICD Coverage click here.

Information on the page is current as of December 3, 2018.
H5355_CMC_18_1134580 Pending Accepted