Medicare Coverage Determinations

Effective October 13, 2023, the Centers for Medicare and Medicaid (CMS) removed NCD 220.6.20 from Publication 100-03, the National Coverage Determination (NCD) Manual. This ended coverage with evidence development (CED) for positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.

This summarizes CMS Transmittal 12364

Effective for items on or after May 16, 2023, power seat elevation equipment is reasonable and necessary for individuals using complex rehabilitative power-driven wheelchairs, when the following conditions are met.

1. The individual has undergone a specialty evaluation that confirms the individual’s ability to safely operate the seat elevation equipment in the home. This 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; and,
   
2. At least one of the following apply:
   1. The individual performs weight bearing transfers to/from the power wheelchair while in the home, using either their upper extremities during a non-level (uneven) sitting transfer and/or their lower extremities 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.); or,
   2. The individual requires a non-weight bearing transfer (e.g. a dependent transfer) to/from the power wheelchair while in the home. Transfers may be accomplished with or without a floor or mounted lift; or,
   3. The individual performs reaching 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. MRADLs may be accomplished with or without caregiver assistance and/or the use of assistive equipment.

This summarizes CMS Transmittal 12183 (NCD 280.16)

Effective for services performed on or after September 26, 2022, the Centers for Medicare and Medicaid expanded coverage for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who 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 cognition. The policy also provides coverage of cochlear implants when performed in the context of FDA-approved category B investigational device exemption clinical trials or as a routine cost in clinical trials under section 310.1 of the National Coverage Determination (NCD) Manual titled Routine Costs in Clinical Trials.
 
This summarizes CMS Transmittal 11875 (NCD 50.3)

Effective January 1, 2023, the Centers for Medicare and Medicaid removed the NCD for Ambulatory EEG Monitoring. In absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors.

This summarizes CMS Transmittal 11824 (NCD 160.22)

Effective for claims with dates of service on or after January 1, 2023, contractors shall be aware that NCD 210.3 Colorectal Cancer Screening Tests has been revised to reduce the minimum age limitation from 50 to 45 years and older for Fecal Occult Blood Tests (FOBT), Multi-target Stool DNA (sDNA) Tests and Blood-based Biomarker Tests. There is also no frequency limitations when the screening coloscopy follows a positive result from a stool-based test.

This summarizes CMS Transmittal 11824 (NCD 210.3)

Effective April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of AD when furnished in accordance with Section B under coverage with evidence development (CED) for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.

This summarizes CMS Transmittal 11692 NCD 200.3

Effective February 10, 2022, CMS expanded Medicare eligibility for screening for lung cancer with LDCT to closely align with the United States Preventive Services Task Force's recommendation. CMS is lowering the minimum age for screening from 55 to 50 years and reducing the smoking history from at least 30 pack-years to at least 20 pack-years.

This summarizes CMS Transmittal 11388 (NCD 210.14)

Effective for dates of service on or after January 1, 2022, Medicare establishes existing duration and frequency limits for medical nutrition therapy (MNT) for certain diabetic and renal disease members as nationally covered.  

This summarizes CMS Transmittal R11272NCD.

Revised 2/21/2022

This affects services given on or after January 1, 2022.

These sections will be removed from Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual. The Centers for Medicare & Medicaid Services determined that no national coverage determination is appropriate at this time. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.

This doesn’t mean the services aren't covered. We’ll still review services that are reasonable and necessary for your diagnosis or condition.

Sections affected:

• NCD 180.2 Enteral and Parenteral Nutritional Therapy
• NCD 220.6 Positron Emission Tomography (PET) Scans

This summarizes CMS Transmittal R11272NCD.
 

Effective for dates of service on or after January 1, 2022, based on the final release of the Medicare Physician Fee Schedule, the conditions which determine coverage for Pulmonary Rehab (PR), Cardiac Rehab (CR), and Intensive Cardiac Rehab (ICR) have been updated. These conditions:  

• Removed PR requirement for direct physician-patient contact.
• Expanded coverage of PR for patients who have confirmed or suspected COVID-19 and experience symptoms which include breathing issues for at least 4 weeks.

This summarizes CMS Transmittal R11272NCD.

Effective for dates of service on or after September 27, 2021, Medicare is expanding coverage of oxygen and oxygen equipment in the home in the following circumstances: 

• Oxygen therapy and oxygen equipment is nationally covered in the home when patients meet specific diagnosis guidelines
• There are also non-covered circumstances based on diagnosis guidelines
• Local Medicare Administrative Contractors (MAC)s may determine that oxygen therapy and oxygen equipment is reasonable and necessary for patients who don’t meet the non-covered guidelines

In addition, CMS is ending coverage of oxygen to treat cluster headache and allowing local Medicare Administrative Contractors (MAC)s to make those coverage determinations.

This summarizes CMS Transmittal R11263 (NCD 240.2 and 240.2.2)

Effective with dates of service on or after January 19, 2021

CMS covers a blood-based biomarker test as part of a colorectal cancer screening test once every 3 years for when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, and ordered by a treating physician and when all of the following requirements are met:

The patient is:

• age 50-85 years,
• 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),
• at 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 blood-based biomarker screening test must have all of the following:

• Food and Drug Administration (FDA) market authorization with an indication for colorectal cancer screening;
• 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), as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

This summarizes CMS Transmittal 10818 (NCD 210.3)

Revised 8/2/2021

This affects services given on or after January 1, 2021

These sections will be removed from Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual. The Centers for Medicare & Medicaid Services determined that no national coverage determination is appropriate at this time. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.

This doesn’t mean the services aren't covered. We’ll still review services that are reasonable and necessary for your diagnosis or condition.

Sections affected:

• NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns
• NCD 30.4 Electrosleep Therapy
• NCD 100.9 Implantation of Gastrointestinal Reflux Devices
• NCD 110.19 Abarelix for the Treatment of Prostate Cancer
• NCD 220.2.1 Magnetic Resonance Spectroscopy
• NCD 220.6.16 FDG PET for Inflammation and Infection

Coverage determinations will fall under NCD 220.6 Positron Emission Tomography (PET) Scans

This summarizes CMS Transmittal 10927

Effective for dates of service on or after August 7, 2019, Medicare covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at specific healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) and used for a medically accepted or an FDA-approved indication and the use is supported in one or more CMS-approved compendia.

(CAR) T-cell therapy is not covered when the use is for a non-FDA-approved autologous T-cells expressing at least one CAR and the requirements listed above are not met.

This summarizes CMS Transmittal 10796 (NCD 110.24)

Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve (previously named Transcatheter Mitral Valve Repair (TMVR) is used in the treatment of mitral regurgitation (MR). TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.

Effective January 19, 2021, Medicare expanded coverage of mitral valve TEER procedures for the treatment of functional mitral regurgitation (MR) and maintained coverage of TEER for the treatment of degenerative MR through coverage with evidence development (CED) and with mandatory registry participation.

This summarizes CMS Transmittal R10985NCD.

For services performed on or after April 13, 2021, Medicare will cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic, nonhealing diabetic wounds. Coverage is  up to 20 weeks when prepared by devices whose FDA-cleared indications include the management of exuding, cutaneous wounds, such as diabetic ulcers.

This summarizes CMS Transmittal R10981NCD.

Effective with dates of service on or after December 1, 2020, Medicare covers left ventricular assist devices (LVADs) if they are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-heart transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:
 

• 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 (OMM), 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.

This summarizes CMS Transmittal R10837 (NCD 20.9.1)

Effective for services performed 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 Clinical Laboratory Improvement.

1. Patient has the following conditions:
 

• ovarian or breast cancer
• a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer
• a risk factor for germline (inherited) breast or ovarian cancer
• not been previously tested with the same germline test using NGS for the same germline genetic content
   

2. The diagnostic laboratory test using NGS must have the following:
 

• the Food and Drug Administration (FDA)-approval or clearance
• results provided to the treating physician for management of the patient using a report
• template to specify treatment options
   

The test needs to be performed in a CLIA-certified laboratory, and ordered by a treating physician. Results are provided to the treating physician for management of the patient and when the patient has the following:
 

• any cancer diagnosis
• a clinical indication for germline (inherited) testing of hereditary cancers
• a risk factor for germline (inherited) cancer
• not been previously tested with the same germline test using NGS for the same germline genetic content
   

This summarizes CMS Transmittal R10346NCD.

This is effective for dates of service on and after January 21, 2020.

Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non-needling techniques.

CMS will cover acupuncture for Medicare patients with chronic Lower Back Pain (cLBP).

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
• not associated with pregnancy
  
  

Up to 12 visits in 90 days are covered. An additional 8 sessions will be covered for those patients demonstrating an improvement.  No more than 20 acupuncture treatments may be administered annually.

Treatment 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.

This summarizes CMS transmittal R10128NCD.

Effective with dates of service on or after December 1, 2020, Medicare covers left ventricular assist devices (LVADs) if they are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-heart transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:
 

• 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 (OMM), 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.

This summarizes CMS Transmittal R10837 (NCD 20.9.1)

Effective for services performed 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 Clinical Laboratory Improvement.

1. Patient has the following conditions:
 

• ovarian or breast cancer
• a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer
• a risk factor for germline (inherited) breast or ovarian cancer
• not been previously tested with the same germline test using NGS for the same germline genetic content
   

2. The diagnostic laboratory test using NGS must have the following:
 

• the Food and Drug Administration (FDA)-approval or clearance
• results provided to the treating physician for management of the patient using a report
• template to specify treatment options
   

The test needs to be performed in a CLIA-certified laboratory, and ordered by a treating physician. Results are provided to the treating physician for management of the patient and when the patient has the following:
 

• any cancer diagnosis
• a clinical indication for germline (inherited) testing of hereditary cancers
• a risk factor for germline (inherited) cancer
• not been previously tested with the same germline test using NGS for the same germline genetic content
   

This summarizes CMS Transmittal R10346NCD.

This is effective for dates of service on and after January 21, 2020.

Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non-needling techniques.

CMS will cover acupuncture for Medicare patients with chronic Lower Back Pain (cLBP).

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
• not associated with pregnancy
  
  

Up to 12 visits in 90 days are covered. An additional 8 sessions will be covered for those patients demonstrating an improvement.  No more than 20 acupuncture treatments may be administered annually.

Treatment 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.

This summarizes CMS transmittal R10128NCD.

For services performed on or after August 7, 2019, The Centers for Medicare & Medicaid Services (CMS) covers autologous (your own blood-forming stem cells are collected) treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) -i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

This summarizes CMS Transmittal R10454NCD.

This is effective for dates of service on and after July 2, 2019.

Ambulatory Blood Pressure Monitoring is a diagnostic test that allows for the identification of various types of high blood pressure.

CMS will cover ABPM for the diagnosis of hypertension in Medicare beneficiaries under the following updated criteria:

• Suspected White Coat Hypertension (WCH), which is defined as average office systolic blood pressure (BP) greater than 130 mm Hg but less than 160 mm Hg or diastolic BP greater than 80 mm Hg but less than 100 mm Hg on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two BP measurements taken outside the office which are less than 130/80 mm Hg.
• Suspected masked hypertension, which is defined as average office BP between 120 mm Hg and 129 mm Hg for systolic BP or between 75 mm Hg and 79 mm Hg for diastolic BP on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two BP measurements taken outside the office which are greater than or equal to 130/80 mm Hg.

For eligible patients, ABPM is covered once per year.

ABPM devices must be:

• Capable of producing standardized plots of BP measurements for 24 hours with daytime and nighttime windows and normal BP bands determined.
• 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

This summarizes CMS Transmittal R10073NCD.

Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead.

Effective for services performed on or after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) covers FDA-approved VNS devices for TRD through Coverage with Evidence Development (CED) when offered in a CMS-approved clinical study. For more information on the approval of CED for VNS, go to CMS Coverage-with-Evidence-Development/VNS

The following criteria must be used to identify patients with TRD:

• The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used.
• The 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 (MDE) 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 major depressive episode
• 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
• Treatment with another investigational device or investigational drugs

VNS is non-covered for the treatment of TRD when furnished outside of a CMS-approved CED study and all other indications of VNS for the treatment of depression are 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.

This summarizes CMS Transmittal R10145NCD. 

For services performed on or after August 7, 2019, The Centers for Medicare & Medicaid Services (CMS) covers autologous (your own blood-forming stem cells are collected) treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) -i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

This summarizes CMS Transmittal R10454NCD.

This is effective for dates of service on and after July 2, 2019.

Ambulatory Blood Pressure Monitoring is a diagnostic test that allows for the identification of various types of high blood pressure.

CMS will cover ABPM for the diagnosis of hypertension in Medicare beneficiaries under the following updated criteria:

• Suspected White Coat Hypertension (WCH), which is defined as average office systolic blood pressure (BP) greater than 130 mm Hg but less than 160 mm Hg or diastolic BP greater than 80 mm Hg but less than 100 mm Hg on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two BP measurements taken outside the office which are less than 130/80 mm Hg.
• Suspected masked hypertension, which is defined as average office BP between 120 mm Hg and 129 mm Hg for systolic BP or between 75 mm Hg and 79 mm Hg for diastolic BP on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two BP measurements taken outside the office which are greater than or equal to 130/80 mm Hg.

For eligible patients, ABPM is covered once per year.

ABPM devices must be:

• Capable of producing standardized plots of BP measurements for 24 hours with daytime and nighttime windows and normal BP bands determined.
• 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

This summarizes CMS Transmittal R10073NCD.

Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead.

Effective for services performed on or after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) covers FDA-approved VNS devices for TRD through Coverage with Evidence Development (CED) when offered in a CMS-approved clinical study. For more information on the approval of CED for VNS, go to CMS Coverage-with-Evidence-Development/VNS

The following criteria must be used to identify patients with TRD:

• The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used.
• The 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 (MDE) 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 major depressive episode
• 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
• Treatment with another investigational device or investigational drugs

VNS is non-covered for the treatment of TRD when furnished outside of a CMS-approved CED study and all other indications of VNS for the treatment of depression are 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.

This summarizes CMS Transmittal R10145NCD. 

This is effective for service on or after April 10, 2018.

CMS determined that MRI for Medicare beneficiaries with the below devices is reasonable and necessary under certain circumstances.

• Implanted Pacemaker (PM)
• Implantable Cardioverter Defibrillator (ICD)
• Cardiac Resynchronization Therapy Pacemaker (CRT-P)
• Cardiac Resynchronization Therapy Defibrillator (CRT-D)

CMS will expand coverage:



• to include CRT-P or CRT-D devices
• for beneficiaries who have an implanted FDA-approved, ICD, CRT-P, or CRT-D
• for beneficiaries with an implanted PM, ICD, CRT-P, or CRT-D device without FDA labeling specific to use in an MRI environment if certain conditions are met

CMS will also remove the Coverage with Evidence Development (CED) requirement.

This summarizes CMS transmittal 208.

This is effective for service on or after March 16, 2018.

The Centers for Medicare & Medicaid Services (CMS) reviewed the evidence for laboratory diagnostic tests using NGS in patients with cancer. They determined that some tests could improve health outcomes for Medicare beneficiaries with advanced cancer. Testing will be covered for beneficiaries with:

• recurrent, relapsed, refractory or metastatic cancer
• advanced stages III or IV cancer if the beneficiary either:
  • has not been previously tested using the same NGS test for the same primary diagnosis of cancer or
  • will get repeat testing using the same NGS test only when the treating physician gives a new primary cancer diagnosis and there will be 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

This summarizes CMS transmittal 215 (replacing 214 and 210).

This is effective for service on or after February 15, 2018.
 

The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias.

CMS will cover ICDs for the following patient indications.

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause.
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause.
   
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy.

Additional indications effective for services performed on or after October 1, 2003:

1. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) ≤ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.)
2. Documented prior MI and a measured LVEF ≤0.30 and a QRS duration of >120 milliseconds (the QRS restriction does not apply to services performed on or after January 27, 2005). Restrictions apply.
   
3. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF ≤ 35%;
4. Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%;
5. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure.
6. Patients with NIDCM >3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met. See documentation for criteria.
   

This summarizes CMS transmittal 213 (replacing 209 & 211).

This is effective for services on or after May 25, 2017.

The Centers for Medicare and Medicaid Services (CMS) issued an NCD to cover SET for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic PAD.

SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest.
SET has been recommended as the initial treatment for patients suffering from IC, the most common symptom experienced by people with PAD.

Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met. The SET program must:

1. Consist of sessions lasting 30-60 minutes, comprising a therapeutic exercise-training program for PAD in patients with claudication
2. Be conducted in a hospital outpatient setting, or a physician’s office
3. Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD
4. Be under the direct supervision of a physician (as defined in Section 1861(r)(1)) of the Social Security Act (the Act), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in Section 1861(aa)(5) of the Act)) who must be trained in both basic and advanced life support techniques.
   

This summarizes CMS transmittal 207 (replacing 204, 205 and 206). 

This is effective for services on or after April 3, 2017.

Local Medicare administrators will decide if they’ll cover topical oxygen for the treatment of chronic non-healing wounds.

This summarizes CMS transmittal 203.

This affects services given on or after January 18, 2017.

CMS covers leadless pacemakers as part of clinical research studies. The study must meet certain criteria and be approved by CMS and the Food and Drug Administration (FDA).

The leadless pacemaker eliminates some causes of complications with traditional pacing systems.

This summarizes CMS transmittal 201.

This affects services given on or after December 7, 2016.
 

This back surgery will be covered if you are part of an approved clinical trial.
 

Other types of surgery for your condition are not covered. This includes endoscopically assisted laminotomy/laminectomy and other open lumbar decompression procedures.
 

This is now expanded to cover a prospective longitudinal study of PILD procedures using an FDA-approved/cleared device if the study completed a CMS-approved randomized clinical trial that met established criteria.

This summarizes CMS transmittal 200 (replacing 167 and 199).

The Centers for Medicare & Medicaid Services (CMS) has reviewed the updated US Preventive Services Task Force (USPSTF) guidance on screening for Hepatitis B Virus (HBV) infection. Effective September 28, 2016, Medicare will cover HBV screening when ordered by a primary care provider for members who meet one of the following conditions:
 

• Asymptomatic, non-pregnant adolescents and adults at high risk for HBV infection
• HBV screening for pregnant women

This summarizes CMS transmittal 195.

This affects services given on or after February 8, 2016.
 

Percutaneous LAAC will be covered only through Coverage with Evidence Development (CED) when the patient both:
 

• Has Nonvalvular Atril Fibrillation (NVAF)
• Follows FDA guidelines for treating percutaneous LAAC while using an FDA-approved device

If you think you qualify, speak with your physician.

To receive coverage, you must have:
 

• A CHADS2 score of 2 or higher (Congestive heart failure, Hypertension, over 75 years old, Diabetes, Stroke/transient ischemia attack/thromboembolism) or a CHA2DS2-VASc score of 3 or higher (Congestive heart failure, Hypertension, 65 years or older, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category) 
• Formally met with and made the decision for treatment with an independent, non-interventional physician 
• Received a recommendation from your physician for short-term warfarin, but you can’t take long-term oral anticoagulation (blood thinners)
  

This summarizes CMS transmittal 192.

This affects services given on or after January 27, 2016.

Expanded coverage of allogenic (donor) hematopoietic stem cell transplantation (HSCT) for:

• Sickle cell disease
• Myelofibrosis
• Multiple myeloma
• Rare diseases

In the HSCT procedure, a doctor takes part of a healthy donor's stem cell or bone marrow and prepares it for intravenous infusion (usually an injection using an IV.) It also includes using high dose chemotherapy and/or radiotherapy before the actual transplant.

This NCD expands coverage for donor HSCT items and services. They’ll only be covered by Medicare if it’s provided in a Medicare-approved clinical study under Coverage with Evidence Development (CED.) When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage.

This summarizes CMS transmittal 193 (replacing 191). 

This affects services given on or after July 29, 2015.

Revised features for covered SGDs include speech generated using one of the following methods:

• Digitized audible/verbal speech output using prerecorded messages
• Synthesized audible/verbal speech output that requires message formulation
• Synthesized audible/verbal speech output for multiple methods of message formulation and device access
• Software that allows a computer or other electronic device to generate audible/verbal speech

Other covered features of the device include the:

• Capability to generate email, text or phone messages to allow the patient to "speak" or communicate remotely
• Capability to download updates to the covered features of the device from the manufacturer or supplier of the device

The cost of non-covered features is the responsibility of the beneficiary. However, in some cases, Medicare administratiors may allow payment for some non-covered SGDs and features. They decide this based on what they find is reasonable and necessary.

This summarizes CMS transmittal 184.

This affects services given on or after July 9, 2015.

HPV testing is now an additional preventive service benefit under the Medicare program. We will cover this testing:

• Once every five years
• If you’re 30 to 65 years old and have no symptoms
• When you have it done with the Pap smear test

To get coverage, you must receive your screening for cervical cancer:

• With the appropriate U.S. Food and Drug Administration (FDA)-approved laboratory test
• In a matter consistent with FDA-approved labeling
• In compliance with the Clinical Laboratory Improvement Act (CLIA) regulations

This summarizes CMS transmittal 189.

This affects services given on or after April 13, 2015.

You can be tested for early detection of HIV if you’re:

• Entitled to benefits under Medicare Part A or enrolled under Part B
• 15 to 65 years old

We will only cover one HIV screening per year if:

• Your doctor or a practitioner in a healthcare setting requests it
• You meet the criteria for the test
• You use a U.S. Food and Drug Administration (FDA)-approved laboratory test or point-of-care test
• Your testing is consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations
• Your test is performed by an eligible Medicare provider

This summarizes CMS transmittal 190.

This affects services given on or after February 5, 2015.

Services affected:

• Lung cancer screening with LDCT once per year
• Visit for counseling and shared-decision making on the benefits and risks of lung cancer screening

To receive these services, as a Medicare beneficiary, you must:

• Be 55 to 77 years old and either a current smoker or have quit smoking within the last 15 years
• Have a tobacco smoking history of at least 30 “pack years” (an average of one pack a day for 30 years)
• Get a written order from a physician or qualified non-physician practitioner like a physician assistant, nurse practitioner or clinical nurse specialist

This affects services given on or after January 13, 2015.

CMS decided that it’s not appropriate to supply a National Coverage Determination for MTWA testing using the modified moving average (MMA) method. The MMA method is a type of heart scan that evaluates patients at risk for sudden cardiac death (SCD), also called cardiac arrest. Because of this decision, this kind of testing will be covered in some areas. Local contractors will decide whether this testing receives Medicare coverage in their service areas. As a Medicare Advantage Organization, Aetna will follow your local Medicare administrator’s policy on covering your heart scan.

This summarizes CMS transmittal R182.

This affects services given on or after December 18, 2014. Unless noted, the effective date is the date of service.

Sections affected:

• 50.6 - Tinnitus masking
• 160.4 - Stereotactic cingulotomy for psychosurgery
• 160.6 - Carotid sinus nerve stimulator
• 160.9 - Electroencephalographic (EEG) monitoring during open-heart surgery
• 190.4 - Electron microscrope
• 220. 7 - Xenon scan
• 220.8 - Nuclear radiology procedure

These sections will be removed from Pub. 100-03, Medicare National Coverage Determinations Manual.

This doesn’t mean the services aren't covered. We’ll still review services that are reasonable and necessary for your diagnosis or condition.

This affects services given on or after October 9, 2014.

Medicare Part B covers Cologuard^TM – a multitarget stool DNA test – once every three years, for Medicare beneficiaries who meet all of the following standards:

• 50 to 85 years old
• No known symptoms: Includes, but is not limited to lower stomach pain, blood in the stool, a positive fecal blood test
• At average risk of getting colorectal cancer: Includes, but is not limited to no personal or family history of colorectal cancer, ulcerative colitis, certain bowel diseases

There is no coinsurance or deductible for the tests that are administered once every three years.

 

This summarizes CMS transmittal 183. 

This affects services given on or after October 01, 2014.

CMS has advised a doctor’s prescription and additional documents must explain the medical need for a hospital bed. Acceptable reasons explaining the medical need include:

• Your condition requires your body to be positioned in ways it can’t in a normal bed. This positioning is done to:
  -Lessen pain
  -Promote good body alignment
  -Prevent contractures
  -Avoid respiratory infections, and more
  
• Your condition requires special attachments that can't be used on an ordinary bed.

A variable-height hospital bed may also be medically necessary and covered for any of the following conditions:

• Severe arthritis and other injuries to your lower body, such as a fractured hip. This is so you can place your feet on the floor while sitting on the edge of the bed.
• Severe heart conditions. This is so you can leave the bed and avoid the strain of “jumping” up or down to do so.
• Spinal cord injuries, including quadriplegic and paraplegic patients, multiple limb amputee and stroke patients. This is to allow you to transfer from bed to a wheelchair with or without help.
• Other severe and limiting diseases or conditions that require a variable-height feature to help you get into or out of bed.

This affects services given on or after August 7, 2014.

Medicare will cover your heart valve surgery if all these apply:

• You were examined by your heart doctor and surgeon.
• They did so at different times.
• Your heart doctor and surgeon list the reasons you need the surgery.
• The government approves the device used in your surgery.
• A heart team manages your care.
• Your heart team and hospital are on the national list of clinical trials.

This summarizes CMS transmittal 178.

This affects services given on or after June 2, 2014.

If your doctor says you’re at high risk, CMS will cover a blood test to see if you have the hepatitis C virus. To be at high risk, you either:

• Had a blood transfusion before 1992
• Use or have used injected drugs that are not legal

CMS must approve the person who does your blood test. CMS will cover the blood test each year if you:

• Tested negative the year before
• Used injected drugs that are not legal since the last blood test

This summarizes CMS transmittal 174.

This affects services given on or after May 6, 2014.

Services affected:

Intensive Cardiac Rehabilitation Program - Benson-Henry Institute Cardiac Wellness Program

If your doctor wants you to take part in this heart wellness program, Medicare will cover it.

This summarizes CMS transmittal 175.

This affects services given on or after May 29, 2013. Updated April 14, 2014.

Aprepitant is a drug used with two others. It prevents nausea and vomiting caused by chemotherapy (chemo).

We cover the oral form, the form you take by mouth, only in certain cases. For example, if your doctor orders it for you right before and within 48 hours after your chemo treatment, it is covered. If you have Medicare Part D, other uses of this oral drug may be covered.

April 4, 2005: CMS announced a NCD for the use of the oral three-drug regimen of aprepitant, a 5HT3 antagonist, and dexamethasone. The regimen is for patients who are receiving the below nine anticancer chemo agents.

• Carmustine
• Cisplatin
• Cyclophosphamide
• Dacarbazine
• Mechlorethamine
• Streptozocin
• Doxorubicin
• Epirubicin
• Lomustine

April 14, 2014: CMS released an additional update to the April 4, 2005 NCD. It is retroactive to May 29, 2013.

The update added more drugs to the existing list of approved anticancer chemo agents.

We now also cover the drugs below for the oral antiemetic three-drug regimen of an oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone:

• Alemtuzumab
• Azacitidine
• Bendamustine
• Carboplatin
• Carmustine
• Cisplatin
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Dacarbazine
• Daunorubicin
• Doxorubicin
• Epirubicin
• Idarubicin
• Ifosfamide
• Irinotecan
• Lomustine
• Mechlorethamine
• Oxaliplatin
• Streptozocin

This summarizes CMS transmittal 165. It replaces and rescinds CMS transmittal 163.

This affects services given on or after February 18, 2014.

Medicare will cover your heart rehabilitation if you have chronic heart failure. This condition must be stable. This means you have taken drugs for your condition for at least six weeks and still have symptoms.

This summarizes CMS transmittal 171.

This affects services given on or after January 27, 2014.

Medicare covers one test a year to see if you have an enlarged blood vessel in your belly. This test is painless. You lie on your back and a technician uses a camera to take images. You need your doctor’s OK to have this test.

Medicare also covers one test a year to see if you have colorectal cancer. For this test, you put a tiny sample of your stool on a special card or cloth. A lab tests it. You need your doctor’s OK to have this test.

This summarizes CMS transmittal 176.

This affects services given on or after October 30, 2013.

Medicare will cover your heart pump if:

• You had a heart transplant
• You’re waiting for a heart transplant
• You’re not a candidate for a heart transplant, but you need the pump and also meet certain clinical conditions

Medicare must approve the hospital you’ll use for this procedure.

Are you waiting for a heart transplant? You must be on an active wait list. It’s maintained by the Organ Procurement and Transplantation Network.

This summarizes CMS transmittal R172.

This affects services given on or after September 27, 2013.

Prior to 9/27/2013, Medicare didn't cover positron emission tomography (PET) beta amyloid imaging (also referred to as PET amyloid-beta (Aβ), based on a longstanding general non-coverage of PET.

Effective 9/27/2013 Medicare will cover one PET Aβ imaging scan if you’re enrolled in certain clinical trials or research studies.

Review more information about this NCD. Clinical study, clinical trial and research study criteria begin on page 7. 

This affects services given on or after September 24, 2013.

CMS has removed the facility certification requirement, which required that these bariatric procedures were covered only when performed at facilities that are:

• Certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center
• Certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE)

Any certifications for other surgical procedures still apply.

This affects services given on or after August 13, 2013.

CMS has advised on the treatment of non-reversible symptomatic bradycardia (slow heart rate). CMS has guided that implanted permanent cardiac pacemakers, single- or dual-chamber, are reasonable and necessary for this condition.

Symptoms of bradycardia happen when your heart rate is less than 60 beats per minute. Symptoms include syncope (fainting), seizures, congestive heart failure, dizziness, or confusion.

This affects services given on or after June 11, 2013.

CMS covers 3 PET scans after you finish your therapy for solid tumors. The scans must be used as a guide for treating your same cancer diagnosis. If you have more than 3 PET scans, your local Medicare administrator will decide if they can be covered.

This affects services given on or after April 3, 2013.

CMS will cover treatment for neovascular age-related macular degeneration with injections of verteporfin. This treatment blocks the development of new blood vessels and leakage from abnormal vessels. In follow-up visits, your doctor will assess how the treatment is working. He/she will do this with either an optical coherence tomography (OCT) or fluorescein angiography.

This services given on and after August 2, 2012.

CMS will cover PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds only when provided under a clinical research study that meets specific requirements. The requirements are that the study assess the health outcomes of PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds.

This affects services given on or after June 27, 2012.

Services provided:

Laparoscopic Sleeve Gastrostomy (LSG), including:

• Open and laparoscopic Roux-en-Y gastric bypass (RYGBP)
• Laparoscopic adjustable gastric banding (LAGB)
• Open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS)

Additional information:

Covers stand-alone laparoscopic sleeve gastrostomy (LSG) for treating other qualified medical conditions related to obesity. Available to Medicare beneficiaries who meet all of the following conditions:

• Body-mass index (BMI) greater than or equal to 35 kg/m
• At least one other qualified medical condition related to obesity
• Previous unsuccessful medical treatment for obesity

Procedure will only be covered when performed at facilities that are certified by either:

1. The American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center
2. The American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006)

This affects services given on or after June 21, 2012.

Covered if you have any of the following:

• Extrahepatic unresectable cholangiocarcinoma (CCA)
• Liver metastases due to a neuroendocrine tumor (NET)
• Hemangioendothelimo (HAE)

The transplant must be performed at an approved liver transplant center. This change does not apply to any other malignancies.

This affects services on or after June 8, 2012.

Covered if:

• You have pain for more than three months
• The pain is not due to a “clearly defined and generally recognizable primary disease”
• You are enrolled in an approved clinical study

This affects services on or after May 1, 2012.

Covered if you’re entered into a qualified national registry and:

• The procedure is done for the treatment of symptomatic aortic stenosis
• The procedure is done for an FDA-approved condition for use with an approved device
• Your use is unapproved by the FDA, but you’re enrolled in a qualifying clinical study

Two heart surgeons must examine you before you receive the TAVR to see if it will work for you.

This affects services given on or after April 30, 2012.

The Centers for Medicare and Medicaid Services (CMS) have added coverage for extracorporeal photopheresis treatment. This is for people who get bronchiolitis obliterans syndrome (BOS) after a lung transplant. You’ll need to enroll in certain clinical research studies for this BOS treatment to be covered. The treatment may help your immune system fight illness better. This study will be used to see if the treatment can improve your health in the following areas:

• Volume of air exhaled in one second
• Survival after transplant
• Quality of life

Extracorporeal photopheresis can be used to treat bronchiolitis obliterans syndrome (BOS) after a lung transplant. It must be provided as part of a clinical research study. These studies must meet specific requirements and be approved on or before April 30, 2014. If no studies are approved by that date, coverage will remain as it was before April 30, 2012.

CMS has added coverage for new preventive services and health risk assessments to the annual wellness visit benefit. This coverage is now available for all Medicare Advantage members. These services:

• Help you find out if you may be at risk for certain health conditions
• Are covered at zero cost sharing and require no coinsurance, copayment or deductible if you use an Aetna participating, in-network primary care provider
• Must be done in a primary care setting

You may have to pay cost sharing if you use an out-of-network provider.

This affects services on or after November 29, 2011.

This therapy includes:

• One face-to-face visit every week for the first month
• One face-to-face visit every other week for months 2-6
• One face-to-face visit every month for months 7-12, if you meet the specified weight loss requirements

This affects services on or after November 8, 2011.

Includes one face-to-face risk reduction visit annually.

This affects services on or after November 8, 2011.

Includes two face-to-face visits annually. Also covers the laboratory screening for chlamydia, gonorrhea, syphilis and hepatitis B. 

This affects services on or after October 14, 2011.

If you screen positive, up to four brief face-to-face behavioral counseling meetings are covered annually.

This affects services on or after October 14, 2011.

Covered if done in a primary care setting that has staff-assisted depression care supports in place.