The Centers for Medicare & Medicaid Services (CMS) makes changes to the services that are covered by Medicare. These changes are updated via National Coverage Determinations.
CMS has issued the following national coverage determinations (NCD):
Effective Dec. 1, 2020: CMS notified their Medicare Administrative Contractors (MACs) that they will cover ventricular assist devices (VADs) under certain conditions and criteria
VADs, or left ventricular assist devices (LVADs), are mechanical blood pumps that are surgically attached to 1 or both intact ventricles of a damaged or weakened heart to assist in pumping blood. Section 20.9.1 of the Medicare NCD Manual established conditions of coverage for VADs.
An NCD that expands coverage is also binding on a Medicare Advantage organization.
VADs and LVADs are covered if they are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-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
- Have a left ventricular ejection fraction (LVEF) equal to or less than 25%
- Are inotrope dependent or have a cardiac index (CI) of 2.2 L/min/m2 while not on inotropes
The patient must also meet 1 of the following conditions:
- Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond
- Have advanced heart failure for at least 14 days and is dependent on an intra‐aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days
Beneficiaries receiving a VAD or LVAD must be managed by a team of medical professionals based at the facility and the team must include individuals with experience working with patients before and after placement of a VAD or LVAD.
The team must include:
- At least 1 physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal LVADs over the course of the previous 36 months with activity in the last year
- At least 1 cardiologist trained in advanced heart failure with clinical competence in medical- and device-based management including VADs, and clinical competence in the management of patients before and after placement of a VAD
- A VAD program coordinator
- A social worker
- A palliative care specialist
CMS posted on
Effective Jan. 19, 2021: CMS has issued an NCD for screening for colorectal cancer
For services performed on or after Jan. 19, 2021, CMS has determined that a blood-based biomarker test is an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when it is:
- Performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Ordered by a treating physician
Additionally, all of the requirements below must be 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:
- 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), based on the pivotal studies included in the FDA labeling
Effective Jan. 19, 2021, CMS issued a reconsideration of a previous NCD expanding coverage of mitral valve Transcatheter Edge-to-Edge Repair (TEER) procedures
This NCD is for mitral valve TEER procedures treating functional mitral regurgitation (MR) and maintained coverage of TEER for treating degenerative MR through coverage with evidence development (CED) and with mandatory registry participation.
Specifically, CMS covers TEER of the mitral valve under CED for treating symptomatic, moderate-to-severe or severe functional MR. This is covered when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate. CMS may also cover TEER for treating significant symptomatic degenerative MR when furnished according to an FDA-approved indication. The NCD also includes hospital infrastructure and procedural volume requirements as well as operate procedural volume requirements.
Effective Apr. 13, 2021, CMS issued an NCD for autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions
Effective for claims with dates of service on and after Apr. 13, 2021, CMS will cover autologous PRP for treating chronic non-healing diabetic wounds for a duration of 20 weeks. The autologous PRP used for treatment must be 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 local MACs. Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by local MACs.
CMS announces removal of 2 national coverage determinations (NCDs), Feb. 18, 2022 update
Effective Date: Jan. 1, 2022: The purpose of this Omnibus change request is to make Medicare contractors aware of the updates to remove 2 National Determination NCDs.
The following 2 NCDs are being removed from the NCD Manual:
- NCD 180.2 Enteral/Parenteral Nutritional Therapy
- NCD 220.6 Positron Emission Tomography (PET) Scans
Coverage of the above 2 NCDs revert to MAC discretion effective for claims with dates of service on and after Jan. 1, 2022.
CMS is expanding the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT), March 2, 2022 update
Effective Feb. 10, 2022: The Centers for Medicare & Medicaid Services (CMS) announced a final decision for a national coverage determination (NCD) titled Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R), which expands coverage for lung cancer screening with low dose computed tomography (LDCT) to improve health outcomes for people with lung cancer.
Medicare beneficiaries may receive low dose computed tomography (LDCT) when the following criteria are met:
- Age 50–77 years
- Asymptomatic (no signs or symptoms of lung cancer)
- Tobacco smoking history of at least 20 pack-years (1 pack-year = smoking 1 pack per day for 1 year; 1 pack = 20 cigarettes)
- Current smoker or one who has quit smoking within the last 15 years
- Received an order for lung cancer screening with LDCT
This final decision:
- Simplifies requirements for the counseling and shared decision-making visit
- Removes the requirement for the reading radiologist to document participation in continuing medical education
CMS added a requirement back to the NCD criteria for radiology imaging facilities to use a standardized lung nodule identification, classification and reporting system.
Effective April 7, 2022: CMS approved use of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease under certain coverage criteria
The Centers for Medicare & Medicaid Services (CMS) 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.
CMS issued a change request to inform interested parties that it is expanding beneficiary eligibility for screening for lung cancer with Low Dose Computed Tomography (LDCT), May 3, 2022 update
Effective February 10, 2022: CMS is expanding beneficiary eligibility for screening for lung cancer with LDCT.
The changes in this update include:
- Expanding beneficiary eligibility for screening for lung cancer with LDCT to closely align with the USPSTF recommendation
- Lowering the minimum age for screening from 55 to 50 years
- Reducing the smoking history from at least 30 pack-years to at least 20 pack-years
- Simplifies requirements for the counseling and shared decision-making visit
- Removes the restriction that it must be furnished by a physician or non-physician practitioner
- Reduces the eligibility criteria for the reading radiologist
- Reduces the radiology imaging facility eligibility criteria
Note: As a result of the revised eligibility criteria for this NCD, CMS is replacing the current text of
Section 210.14 of the NCD Manual, Publication (Pub.) 100-03, Chapter 1, Part 4, and section 220,
chapter 18 of the Claims Processing Manual, Pub. 100-04.
Effective July 1, 2020: CMS issued an update to the Medicare National Coverage Determinations (NCD) Manual regarding Next-Generation Sequencing (NGS). An NCD that expands Original Medicare coverage and is also binding on Medicare Advantage organizations
CMS has rescinded and replaced Transmittal 11055 (LRR-2021-GOV-5629445) with Transmittal 11461. CMS has revised Business Requirement 12483.1 and the corresponding spreadsheet to align with changes made in previous change requests. All other information remains the same.
Effective April 7, 2022: CMS Transmittal – National Coverage Determination (NCD) 200.3 – Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD)
Effective April 7, 2022, 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 the 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.
Monoclonal antibodies directed against amyloid indicated for the treatment of AD are covered when furnished according to the FDA-approved indication in National Institutes of Health (NIH)-supported trials.
For any CMS-approved study or NIH-supported trial that includes a beta amyloid positron emission tomography (PET) scan as part of the protocol, it has been determined that these trials or studies also meet the CED requirements included in the Beta Amyloid PET in Dementia and Neurodegenerative Disease NCD (220.6.20).
Monoclonal antibodies directed against amyloid for the treatment of AD provided outside of an FDA approved randomized controlled trial, CMS approved studies, or studies supported by the NIH, are nationally non-covered.
Individually approved clinical trials require a new HCPCS code specific to the therapy being studied. Therapies with FDA approval that have not been assigned a dedicated HCPCS code would be identified by existing HCPCS codes J3490, J3590. Subsequent Transmittals will follow.
Effective Sep. 26, 2022: CMS sent email notice that a final NCD and decision memo for cochlear implantation has been posted.
CMS is broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40% and ≤ 60%, Cochlear Implantation may be covered:
- Only when the provider is participating in and patients are enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a prospective, controlled comparative trial approved by CMS.
CMS concluded that the evidence is sufficient to determine that Cochlear Implantation may be covered 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. Patients must meet all of the following criteria.
- Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;
- Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
- Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;
- No contraindications to surgery; and
- The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.
Effective Jan. 1, 2023: CMS issued Transmittal 11597 to inform the Medicare Administrative Contractors (MACs) of the changes associated with this NCD, effective Sept. 27, 2021, as amended July 8, 2022.
CMS issued transmittal to communicate the revision of 240.2 of the National Coverage Determination (NCD) Manual, Publication (Pub.) 100-03, Chapter 1, Part 4, and to inform the Medicare Administrative Contractors (MACs) of the changes associated with this NCD, effective Sept. 27, 2021, as amended July 8, 2022.
On July 8, 2022, CMS reconsidered and amended NCD 240.2 narrowly in order to conform the period of initial coverage described in section D with the specific time period specified in §1834(a)(5)(E) of the Social Security Act. Specifically, CMS amended the period of initial coverage for patients in section D of NCD 240.2 from 120 days to 90 days, in order to align with the 90-day statutory time period. No other part of NCD 240.2 was reconsidered or amended. Since §1834(a)(5)(E) of the Social Security Act was the continuous controlling authority, the coverage policies in NCD 240.2 remain effective as of Sept. 27, 2021.
Effective Jan. 1, 2022: (CMS) provided, to Original Medicare, updated instructions on how to process claims in the Part B physician office and independent clinics for Chimeric Antigen Receptor (CAR) T-Cell Therapy.
The Centers for Medicare & Medicaid Services (CMS) reviewed the evidence for CAR T-cell therapy in patients with cancer, and will cover Food and Drug Administration (FDA)-approved CAR T-cell therapy under the conditions specified in Publication 100-03, National Coverage Determination (NCD) Manual, section 110.24. Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA 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.
Update 12/30/2022
Transmittal 11721 issued November 28, 2022, is being rescinded and replaced by Transmittal 11774, dated, December 30, 2022 to revise the implementation date and to:
- Remove duplicate Business Requirement (BR) 12928.3 and replace with the intended language,
- Clarify 1 unit per HCPCS code in BRs 12928.7, 12928.8, 12928.8.1,
- Clarify modifier -Q1 not -Q0 in BRs 12928.10, 12928.11,
- Change date to October 1, 2021 in BR 12928.11,
- Remove Part A from BR 12928.8.1,
- Where discussing NCD 310.1 replace 'FDA-approved' with 'qualifying clinical trial'.
- Revise the IOM, the background section of the requirements, and the NCD excel file.
All other information remains the same.
Effective January 1, 2023: CMS issued a change request to make contractors aware of policy updates resulting from changes specified in the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) Final Rule. The policy updates include removal of one selected National Coverage Determination (NCD): Ambulatory Electroencephalographic (EEG) Monitoring.
Date of Transmittal: January 27, 2023
*Unless otherwise specified, the effective date is the date of service.
IMPLEMENTATION DATE: February 27, 2023 - Requirements Implementation Date; April 3, 2023 - For Release Tracking Purposes Only
Separately, the policy updates also include policies to expand colorectal cancer screening coverage by:
- Reducing the minimum age for certain Colorectal Cancer (CRC) screening tests from 50 to 45 years
- Expanding the regulatory definition of CRC screening tests to include a follow-on screening colonoscopy after a Medicare covered non-invasive stool-based test returns a positive result.
NCD Removal:
- CMS finalized a proposal to remove NCD 160.22 EEG Monitoring
CRC Screening:
- The minimum age payment and/or coverage limitation for the following CRC screening tests is now reduced to 45 years of age or older:
- Screening Flexible Sigmoidoscopy Test
- Screening Guaiac-based Fecal Occult Blood Test (gFOBT)
- Screening Immunoassay-based Fecal Occult Blood Test (iFOBT)
- Screening The Cologuard™ – Multi-target Stool DNA (sDNA) Test
- Screening Barium Enema Test
- Screening Blood-based Biomarker Test
Effective July 31, 2023: CMS issued the transmittal 12112 to communicate the proposed technical manual changes that were made to the National Coverage Determination (NCD) Manual, Publication 100-03, Chapter 1 Parts 1, 3, and 4.
The changes in this update include:
- In Chapter 1, Part 1, Section 20.33 Transcatheter Edge-To-Edge (TEER) for Mitral Valve Regurgitation title was corrected to align with the title of the NCD.
- In Chapter 1, Part 1, Section 20.4 Implantable Cardioverter Defibrillators (ICDs), in Part B number 4 added verbiage ‘or cardiac arrest due to VF’ to align with Section I of the Final Decision Memo.
- In Chapter 1, Part 3, Section 190.1 Histocompatibility Testing, removed 4 bullets and replaced them with letters to align with the original Coverage Issues Manual language.
- In Chapter 1, Part 4, Section 280.1, in the DME reference list, the Muscle Stimulator hyperlink is being changed from 250.4 to 160.12 to refer back to the correct section in the manual.
Effective August 4, 2023: CMS has advised of the following policy updates effective for claims with dates of service on and after January 1, 2024
The changes in this update include:
- One initial acupuncture HCPCS (97810 OR 97813) shall be allowed to be reported with or without HCPCS add-on code(s) (97811 AND/OR 97814) on the same date of service (DOS) and this equals one session. Only one initial code HCPCS 97810 OR 97813 can be reported per DOS.
- Dry needling HCPCS 20560 OR 20561 shall be allowed to be reported and this equals one session. Dry needling and acupuncture are disallowed on the same DOS. HCPCS 20560 & 20561 are disallowed on the same DOS as HCPCS 97810, 97811, 97813, or 97814).
- All other existing editing other than the frequency described above that is contained in CRs 11755, 12480, and 12822, remain in effect
Effective May 16, 2023: CMS issued a Benefit Category Determination and National Coverage Determination (NCD 280.16) for power seat elevation equipment on certain power wheelchairs.
Effective for claims with dates of service 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 under NCD 280.16:
- 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
- At least one of the following apply:
- 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); or,
- 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,
- 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.
Effective August 17, 2023: CMS issued a memo regarding the Significant Cost Determination for Medicare Coverage of Monoclonal Antibodies for the Treatment of Alzheimer's Disease
CMS has determined that the cost of coverage for monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer's disease under NCD 200.3 does not meet the significant cost threshold. Therefore, MA plans are required to assume the costs and cover anti-amyloid monoclonal antibodies antibody treatments for Alzheimer’s following the coverage criteria set forth under NCD 200.3.
Consistent with procedures under Traditional Medicare, Medicare Advantage plans must collect the applicable registry trial number on each claim or encounter for monoclonal antibodies that receive traditional approval from the FDA.
Effective January 1, 2023: CMS issued a change request to make contractors aware of policy updates resulting from changes specified in the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) Final Rule. The policy updates include removal of one selected National Coverage Determination (NCD): Ambulatory Electroencephalographic (EEG) Monitoring and Expanding Coverage of Colorectal Cancer Screening.
Transmittal 11865 issued February 16, 2023, is being rescinded and replaced by Transmittal 12299, dated October 12, 2023, to provide clarifications on CMS policy and related claims processing instructions for our approach to colonoscopies within the context of a complete colorectal cancer screening by revising the policy section with additional verbiage, adding Business Requirement (BR) 13017 - 04.5.3, and revising BRs 13017-04.1 and 13017 - 04.4 to 13017 - 04.10. This CR is amended to remove the requirement (and corresponding Pub. 100-04 narrative) that contractors shall return to provider/ return as un-processable certain screening colonoscopy claims that do not include the KX modifier. This correction does not make any revisions to the companion Pub. 100-02 or Pub. 100-03; all revisions are associated with Pub. 100-04. All other information remains the same.
Separately, the policy updates also include policies to expand colorectal cancer screening coverage by:
- Reducing the minimum age for certain Colorectal Cancer (CRC) screening tests from 50 to 45 years
- Expanding the regulatory definition of CRC screening tests to include a follow-on screening colonoscopy after a Medicare covered non-invasive stool-based test returns a positive result.
Effective October 11 , 2023: National Coverage Determination (NCD) 20.7 Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting
On October 11, 2023, CMS issued an NCD updating coverage under section B4 of NCD 20.7. 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%.
As a result of the revised eligibility criteria for this NCD, CMS is replacing the current text of 20.7 sections B4 and D of the NCD Manual, Publication (Pub.) 100-03, Chapter 1, Part 1, and Chapter 32, Section 160 of the Claims Processing (MCP) Manual, Pub. 100-04.
Effective March 6, 2024: National Coverage Determination (NCD) 110.23, Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS)
On March 6, 2024, CMS issued a final decision under National Coverage Determination (NCD) 110.23 to expand Medicare coverage for allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients with MDS 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 (IPSS-R), or
- ≥ 0.5 (high or very high) using the Molecular International Prognostic Scoring System (IPSS-M)
Additional instruction may be found in: Publication (Pub) 100-03, NCD Manual, chapter 1, section 110.23, for information regarding this NCD and Pub. 100-04, Claims Processing Manual (CPM), chapter 3, section 90.3.1.