National Coverage Determination

Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

The Centers for Medicare & Medicaid Services (CMS) will cover tricuspid transcatheter edge-to-edge repair (T-TEER) for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED) when furnished according to a Food and Drug Administration (FDA) market-authorized indication and despite optimal medical therapy (OMT), patients must have symptomatic TR with tricuspid valve repair being considered as appropriate by a heart team. The National Coverage Determination (NCD) also includes Physician Criteria and CED Study criteria that must be met.

Tricuspid transcatheter edge-to-edge repair (T-TEER) is not covered for patients outside of a CMS-approved study.

Nothing in this NCD would preclude coverage of T-TEER through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy.

For detailed coverage requirements, you may view the full text at National Coverage

Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD) The Centers for Medicare & Medicaid Services (CMS) will cover Respiratory Assist Devices (RADs) with bi-level capability, with or without a backup rate feature. RADs are devices that use a non-invasive interface (mask) to deliver a higher level of airway pressure when the patient inhales than when the patient exhales. A backup rate feature on certain RADs enables the device to provide a prespecified respiratory rate if the patient’s spontaneous respiratory rate decreases below a set number.

RAD with Backup Rate Feature will be covered in the home to deliver high intensity noninvasive ventilation (NIV) as treatment for patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). A RAD with backup rate feature is covered in the home for an initial 6-month period for patients with COPD when the patient meets all the criteria in the National Coverage Determination (NCD). By the end of the initial 6-month period, a RAD with backup rate feature must be utilized as high intensity therapy, defined as a minimum IPAP ≥ 15 cm H2O and backup respiratory rate of at least 14 breaths per minute.

RAD without Backup Rate Feature will be covered in the home for a patient with CRF consequent to COPD who cannot tolerate high intensity NIV or for whom the backup rate feature is otherwise medically inappropriate. A RAD without backup rate feature is covered in the home for an initial 6-month period for patients with COPD when the patient meets all the criteria in the NCD.

CMS will cover in the home a RAD with or without backup rate feature immediately upon hospital discharge for an initial 6-month period for patients with acute on chronic respiratory failure due to COPD, if the patient required either a RAD or ventilator within the 24-hour period prior to hospital discharge and the treating clinician determines that the patient is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge. For continuing use of a RAD, patients must be evaluated at least twice within the first year after initially receiving a RAD. Evaluations must occur by the end of the six-month initial coverage period and again during months 7-12 and patients must meet the criteria in the NCD.

CMS will cover a home mechanical ventilator (HMV) used in a volume targeted mode as treatment for a patient with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD) who exhibits certain clinical characteristics. An HMV is covered for an initial 6-month period for patients with COPD when all of the criteria in the NCD are met.

CMS will cover in the home an HMV used in a volume targeted mode immediately upon hospital discharge for an initial 6-month period for patients with acute on chronic respiratory failure due to COPD if the patient’s needs exceeded the capabilities of a RAD (with or without backup rate feature) and required usage of a ventilator within the 24-hour period prior to hospital discharge and the treating clinician determines that the patient is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge.

For continuing use of an HMV, patients must be evaluated at least twice within the first year after initially receiving an HMV. Evaluations must occur by the end of the six-month initial coverage period and again during months 7-12 and patients must meet the criteria in the NCD.

Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations for any patient seeking initial coverage or continued coverage for RADs or HMVs used as treatment of chronic respiratory failure consequent to COPD.

For detailed coverage requirements, you may view the full text at National Coverage Determination 240.9

Transcatheter Tricuspid Valve Replacement (TTVR)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter tricuspid valve replacement (TTVR) for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED) when furnished according to a Food and Drug Administration (FDA) market-authorized indication and despite optimal medical therapy (OMT), patients must have symptomatic TR with tricuspid valve replacement being considered as appropriate by a heart team. The National Coverage Determination (NCD) also includes Physician Criteria and CED Study criteria that must be met.

Transcatheter tricuspid valve replacement (TTVR) is not covered for patients outside of a CMS approved study. Nothing in this NCD would preclude coverage of TTVR through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy.

For detailed coverage requirements, you may view the full text at National Coverage Determination 20.37

Transcatheter Edge-to-Edge Repair (TEER) for Mitral Value Regurgitation

The Centers for Medicare and Medicaid (CMS) will cover a TEER of the mitral valve under Coverage with Evidence Development (CED) for the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated Guideline-Directed Medical Therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or for the treatment of significant symptomatic degenerative MR when furnished according to an FDA-approved indication. The National Coverage Determination (NCD) also includes hospital infrastructure and procedural volume requirements, as well as operator procedural volume requirements.

• For uses that aren’t expressly listed as an FDA-approved indication, patients must be enrolled in qualifying clinical studies. Find approved studies on the CMS website. Note: CMS restructured NCD 20.33 and renamed it from Transcatheter Mitral Valve Repair (TMVR) to TEER for mitral valve regurgitation to lay out coverage requirements more clearly and specify what procedures fall under the NCD.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=363&ncdver=2&bc=0.

Colorectal Cancer Screening Blood-Based Biomarker Test

The Centers for Medicare and Medicaid (CMS) will cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every three years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following requirements are met: 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,
• 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).

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=281&ncdver=6.

Blood-Derived Products for Non-Healing Wounds

The Centers for Medicare and Medicaid (CMS) will cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds for a duration of 20 weeks, when prepared by devices whose FDA-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers.

• Coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks will be determined by the local Medicare Administrative Contractors (MACs).
• Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by the local MACs.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=217&ncdver=6&bc=0.

Home Oxygen Use

The Centers for Medicare and Medicaid (CMS) will cover oxygen therapy and oxygen equipment in the home for acute or chronic conditions, short- or long- term, when the patient exhibits hypoxemia.

• Medicare Administrative Contractors (MAC) may determine reasonable and necessary coverage of oxygen therapy and oxygen equipment in the home for patients who do not meet specific diagnosis guidelines.
• Initial coverage for patients with other conditions may be limited to the shorter of 120 days or the number of days included in the practitioner prescription at MAC discretion. Oxygen coverage may be renewed if deemed medically necessary by the MAC.
• MACs may also allow beneficiaries who are mobile in the home and would benefit from the use of a portable oxygen system in the home to qualify for coverage of a portable oxygen system either (1) by itself, or (2) to use in addition to a stationary oxygen system.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=169&ncdver=2.

2022 Medical Nutrition Therapy

The Centers for Medicare and Medicaid (CMS) will cover basic coverage of Medical Nutrition Therapy (MNT), for the first year a beneficiary receives MNT, with either a diagnosis of renal disease or diabetes is three hours of administration. Basic coverage in subsequent years for renal disease or diabetes is two hours. The dietitian/nutritionist may choose how many units are administered per day as long as all of the other requirements in this NCD are met.

If the physician determines that receipt of both MNT and DSMT is medically necessary in the same episode of care, Medicare will cover both DSMT and MNT initial and subsequent years without decreasing either benefit as long as DSMT and MNT are not provided on the same date of service.

• Additional hours are considered to be medically necessary and covered if the physician determines that there is a change in medical condition, diagnosis, or treatment regimen that requires a change in MNT and orders additional hours during that episode of care.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=252.

Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

The Centers for Medicare & Medicaid Services (CMS) reconsidered the national coverage determination established at section 210.14 of the Medicare National Coverage Determinations manual and has determined that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following beneficiary eligibility criteria are met:

• Age 50 – 77 years;
• 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; and
• Receive an order for lung cancer screening with LDCT.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=304.

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

The Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) when furnished in accordance with Section B (Coverage Criteria) 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. For detailed coverage requirements, you may view the full text of the NCD at cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.