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National Coverage Determination (NCD) notices

When Medicare changes coverage rules

The Centers for Medicare & Medicaid Services (CMS) sometimes changes the coverage rules that apply to an item or service. When this happens, CMS issues an NCD. It tells us:

 

  • What benefits and services are covered

  • What benefits and services are changing

  • What Medicare will pay for an item or service 

 

See our NCD notices below.

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)

CMS is revising NCD 240.2, Home Use of Oxygen, to nationally expand patient access to oxygen and oxygen equipment in the home. The revised NCD also identifies circumstances of non-coverage of home oxygen and oxygen equipment.

 

In addition, CMS is removing NCD 240.2.2, ending coverage with evidence development for home use of oxygen to treat cluster headache, and allowing the coverage determinations regarding the use of home oxygen and oxygen equipment for patients with cluster headaches.

Effective January 1, 2022

 

Medicare removed two National Coverage Determinations (NCD's):

 

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

 

CMS also made coverage updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) policies resulting from changes specified in the calendar year 2022 Physician Fee Schedule (PFS) final rule published on November 19, 2021.

 

This summarizes CMS Transmittal R11272NCD

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. (NCD 270.3)

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. (NCD 20.33)

Effective with dates of service on or after 12/01/2020

 

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) 

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 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)

This affects services given on or after August 7, 2019

 

Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment. The recent NCD changes are as follows:

 

Effective for claims with dates of service on and after August 7, 2019.

 

CMS will cover autologous treatment for cancer with T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) and meets specified FDA conditions.

 

If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R10454NCD

 

 

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)

·         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)

This affects services given on or after January 21, 2020

 

Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment. The recent NCD changes are as follows:

 

  • CMS will cover acupuncture for chronic low back pain (cLBP) effective for claims with dates of service on and after January 21, 2020.

 

This NCD expands coverage for acupuncture services specifically targeted for chronic low back pain. Medicare determined it will cover acupuncture for cLBP up to 12 visits in 90 days. These services will only be covered by Medicare if cLBP:

 

  • lasts 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 

 

If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R10128NCD

This affects services given 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 R210NCD

This is effective for service 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 R203NCD

This affects services given on or after April 10, 2018

 

Medicare will allow for coverage of MRI for beneficiaries under certain conditions with any of the following: implanted pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D).

 

If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R208NCD

This affects services given on or after January 27, 2016

 
Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment done as part of special studies (Coverage with Evidence Development/CED, Medicare approved studies). These changes only apply to members involved in the special studies. The recent NCD changes are as follows:

 

  • Expanded coverage for donor stem cell transplant (allogenic hematopoietic stem cell transplant) for sickle cell disease, certain diseases of the blood cells (myelofibrosis, multiple myeloma), other rare diseases. In a donor stem cell transplant, a doctor takes part of a healthy donor’s stem cell or bone marrow. This is then specially prepared and given to a patient through a tube in a vein (intravenous infusion). The patient also receives high dose chemotherapy (such as certain cancer drugs) and/or radiation treatments before getting this transplant through the vein.

 

This NCD expands coverage for donor HSCT items and services. These services will only be covered by Medicare if they are 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 required steps are included in coverage. If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R191NCD.

This affects services given on or after February 8, 2016

 
Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment done as part of special studies (Coverage with Evidence Development/CED, Medicare approved studies). These changes only apply to members involved in the special studies. The recent NCD changes are as follows:

 

  • Coverage will be approved for a special heart procedure (Left Atrial Appendage Closure, LAAC, if the device planned for use has FDA approval; and

  • You have a specific type of irregular heart beat (Non-Valvular Atrial Fibrillation, NVAF; and

  • You meet all the other specified conditions of the Medicare approved study. 

 

These services will only be covered by Medicare if they are provided in a Medicare-approved clinical study under Coverage with Evidence Development (CED). If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R192NCD.

This affects services given on or after October 9, 2014

 
Cologuard is a test that is performed on a stool sample to check for colon cancer. You no longer need authorization from your health plan before you have this test done.

 

This summarizes CMS transmittal R183NCD.

This affects services given on or after August 30, 2016

 
Centers for Medicare and Medicaid Services (CMS) recently released a notice in response to public questions around gender reassignment surgeries. This notice restates that there are no national CMS coverage guidelines for this service. Coverage decisions for this type of surgery are made by your local Plan, according to your benefits and your Plan’s medical necessity guidelines. If you have any questions about your coverage for this type of surgery, please contact Member Services at number on your Member ID.

 

This summarizes CMS transmittal R194NCD.

This affects services given on or after December 7, 2017.

 
Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment done as part of special studies (Coverage with Evidence Development/CED, Medicare approved studies). These changes only apply to members involved in the special studies. The recent NCD changes are as follows:

 

  • You are having surgery on your lower spine where the surgeon uses a very small incision and surgery is guided with imaging (x-ray) assistance (often referred to as “Percutaneous Image-guided Lumbar Decompression”/PILD).

  • You have a condition where the open spaces of your spine are narrowed and this puts pressure on your spinal cord or nerves (“Lumbar Spinal Stenosis”) and you have not had relief with non-surgical treatments.

  • You meet all the other specified conditions of the Medicare approved study. 

 

These services will only be covered by Medicare if they are provided in a Medicare-approved clinical study under Coverage with Evidence Development (CED). If you think you qualify, speak with your physician.

 

This summarizes CMS transmittal R196NCD.

This affects services given on or after January 18, 2017

 
Centers for Medicare and Medicaid Services (CMS) has issued National Coverage Determinations (NCD’s) that affect coverage for treatment done as part of special studies (Coverage with Evidence Development/CED, Medicare approved studies). These changes only apply to members involved in the special studies. The recent NCD changes are as follows:

 

Medicare will cover placement of a “leadless pacemaker” if you are enrolled in a special approved clinical study. A leadless pacemaker is placed without the need for a device pocket and insertion of a pacing lead which are parts of traditional pacing systems. You should speak with your doctor if you think you qualify to be a participant in an approved clinical study to receive this device.”

 

This summarizes CMS transmittal R201NCD.

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.

 

The SET program must:

 

  • Consist of sessions lasting 30-60 minutes, comprising a therapeutic exercise-training program for PAD in patients with claudication

  • Be conducted in a hospital outpatient setting, or a physician’s office

  • Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD 

  • 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 R207NCD.

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 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 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.

Sections affected: Refer to CMS Publication 100-03, NCD Manual, Chapter 1, part 2, section 160.22

 

This summarizes CMS Transmittal 11824 (NCD 160.22)

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 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:
  3. 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,
  4. 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,
  5. 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 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 or claims with dates of service on or after October 11, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) of 20.7. Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. The updated NCD covers PTA of the carotid artery concurrent with stenting with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries with symptomatic carotid artery stenosis ≥50%, and asymptomatic carotid artery stenosis ≥70%. The NCD also sets forth requirements regarding neurological assessments, imaging, shared decision making, and retains institutional and physician standards. It removes the requirement that facilities that perform CAS procedures must be approved by CMS. Additionally, CMS revised section D of NCD 20.7 to allow MACs to make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting. 

 

This summarizes CMS Transmittal 12571 NCD20.7

Effective for services performed on or after March 6, 2024, allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients with myelodysplastic syndromes who have prognostic risk scores of:  

 

  • ≥ 1.5 (Intermediate-2 or high) using the International Prognostic Scoring System (IPSS), or 
  • ≥ 4.5 (high or very high) using the International Prognostic Scoring System - Revised (IPSS1R), or 
  • ≥ 0.5 (high or very high) using the Molecular International Prognostic Scoring System (IPSS1M). 

For these patients, the evidence demonstrates that the treatment is reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act (the Act). 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 under section 1862(a)(1)(A). 

 

This summarizes CMS Transmittal 12627 NCD 110.23 

This information is not a complete description of benefits.  Call 1-844-362-0934 (TTY: 711) for more information.

Also of interest: