National Coverage Determination

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.