Your source for updates to Medicare-covered services

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 June 12, 2020: Transcatheter aortic valve replacement (TAVR)

[Unless otherwise specified, the effective date is the date of service.]

The Centers for Medicare & Medicaid Services (CMS) has issued an NCD to continue covering TAVR through Coverage with Evidence Development (CED). Effective for claims with dates of service on and after June 21, 2019, plans/contractors shall continue to cover TAVR through CED when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an indication approved by the Food and Drug Administration (FDA) for use with an approved device. CED requires that each patient be entered into a qualified national registry.

For uses that are not expressly listed as an FDA-approved indication, patients must be enrolled in qualifying clinical studies. All clinical research study protocols must address prespecified research questions, adhere to standards of scientific integrity and be reviewed and approved by CMS. Approved studies will be posted to the CMS website, opens new window.

TAVR is not covered for patients in whom existing comorbidities would preclude the expected benefit from correction of the aortic stenosis.

CMS has updated the Medicare Claims Processing and National Coverage Determination manuals to align with the final decision memo for TAVR. All other information in the transmittals remains the same.

Transmittals 217 and 4546 are being rescinded and replaced by Transmittals 10179, one for each manual, dated June 10, 2020.

Effective May 8, 2020: National coverage determination (NCD) and local coverage determination (LCD) requirements during the public health emergency (PHE) for the COVID-19 pandemic

The Centers for Medicare & Medicaid Services (CMS) has finalized, on an interim basis, that required in-person encounters would not apply and that CMS will not enforce clinical indications for coverage across certain NCDs during the PHE:

  • To the extent an NCD or LCD would otherwise require a face-to-face or in-person encounter or other implied face-to-face services, those requirements would not apply.
  • CMS will not enforce the clinical indications for coverage across respiratory, home anticoagulation management, therapeutic continuous glucose monitors and infusion pump NCDs and LCDs (including articles), allowing flexibility for practitioners to care for their patients.

Effective January 21, 2020: Acupuncture for chronic low back pain (cLBP)

[Unless otherwise specified, the effective date is the date of service.]

The CMS has issued communications advising Medicare Administrative Contractors (MACs) that CMS will cover acupuncture for cLBP, effective for claims with dates of service on and after January 21, 2020. An NCD that expands coverage is also binding on Medicare Advantage organizations.

Effective for claims with dates of service on and after January 21, 2020, up to 12 visits in 90 days are covered for cLBP under the following circumstances:

  • For the purpose of this decision, 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
  • An additional 8 sessions will be covered for those patients demonstrating an improvement. No more than 20 acupuncture treatments may be administered annually. Example: If the 1st service is performed on March 21, 2020, the next service beginning a new year cannot be performed until March 1, 2021. This means 11 full months must pass from the date of the 1st service before eligibility begins again.
  • Treatment must be discontinued if the patient is not improving or is regressing.

Physicians, physician assistants, nurse practitioners/clinical nurse specialists and auxiliary personnel may furnish acupuncture in accordance with applicable state requirements and an appropriate level of supervision.

Acupuncture is only covered for treatment of cLBP. All other types of acupuncture, including dry needling for any other condition, is still not covered by Medicare.

Effective July 2, 2019: Ambulatory blood pressure monitoring (ABPM)

[Unless otherwise specified, the effective date is the date of service.]

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after July 2, 2019, Medicare will allow for coverage of ABPM for beneficiaries under certain conditions.

ABPM is a diagnostic test that allows for the identification of various types of high blood pressure. ABPM devices are small portable machines that are connected to a blood pressure cuff worn by patients. The devices record blood pressure at regular periods over 24 to 48 hours while the patient goes about his or her normal activities, including sleep. The recording is interpreted by a physician or nonphysician practitioner, and appropriate action is taken based on the findings.

As of July, 2, 2019, CMS will cover ABPM for the diagnosis of hypertension in Medicare beneficiaries under the following circumstances:

  1. For beneficiaries with suspected white coat hypertension (WCH), which is defined as average office systolic blood pressure (BP) greater than 130 mmHg but less than 160 mmHg or diastolic BP greater than 80 mmHg but less than 100 mmHg on 2 separate clinic/office visits with at least 2 separate measurements made at each visit and with at least 2 BP measurements taken outside the office that are less than 130/80 mmHg
  2. For beneficiaries with suspected masked hypertension, which is defined as average office BP between 120 mmHg and 129 mmHg for systolic BP or between 75 mmHg and 79 mmHg for diastolic BP on 2 separate clinic/office visits with at least 2 separate measurements made at each visit and with at least 2 BP measurements taken outside the office that are greater than or equal to 130/80 mmHg

ABPM devices must be:

  • Capable of producing standardized plots of BP measurements for 24 hours with daytime and nighttime windows and normal BP bands demarcated
  • Provided to patients with oral and written instructions, with a test run taking place in the physician’s office
  • Interpreted by the treating physician or treating nonphysician practitioner

Effective July 2, 2019, for eligible patients, ABPM is covered once per year.

Effective February 15, 2019: Vagus nerve stimulation (VNS)

[Unless otherwise specified, the effective date is the date of service.]

The Centers for Medicare & Medicaid Services (CMS) has issued Original Medicare instructions regarding coverage of VNS, national coverage determination (NCD) for treatment resistant depression (TRD).

An NCD that expands coverage is also binding on a Medicare Advantage organization.

VNS is a type of brain stimulation therapy that uses a small battery-powered generator (similar to a pacemaker) to send mild pulses of electrical energy to the brain. An external device programs and adjusts the timing and intensity of these pulses from the implanted VNS device.

Effective for claims with dates of service on or after February 15, 2019, CMS will cover Food and Drug Administration-approved VNS devices for TRD through coverage with evidence development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least 1 year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized, placebo-controlled trial has completed enrollment and there are positive interim findings.

CMS has updated the Medicare NCD manual, which indicates the conditions of coverage for VNS.

Each study must be approved by CMS and as a fully described, written part of its protocol, must address whether VNS improves health outcomes for TRD patients compared to a control group, by answering all of the research questions included in the coverage criteria. There is also criteria that must be used to identify patients demonstrating TRD. Individuals who receive placebo VNS will be offered active VNS at the end of the trial.

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

NOTE: VNS for medically refractory seizures and hypoglassal nerves continue to be processed as they are currently.

Effective April 10, 2018: Magnetic Resonance Imaging (MRI)

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after April 10, 2018, Medicare will allow for coverage of MRI for beneficiaries under certain conditions. CMS has determined that MRI for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary under certain circumstances.

Effective Date: March 16, 2018: Next Generation Sequencing (NGS)

[unless otherwise specified, the effective date is the date of service]

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after March 16, 2018, Medicare will allow for coverage of diagnostic laboratory tests that use Next-Generation Sequencing (NGS)* under specified conditions.

CMS will cover such testing under the Medicare program for beneficiaries with recurrent, relapsed, refractory, metastatic cancer, or advanced stages III or IV cancer if the beneficiary has either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician, and decided to seek 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.

Additionally, Medicare Administrative Contractors may determine coverage of other diagnostic laboratory tests using NGS for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by the treating physician and the patient has:

  • Either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and
  • Either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and
  • Decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer under either national or local coverage criteria.

*NGS consistent with NCD Manual, Publication 100.3, Part 1, Section 90.2

Effective Date: February 15, 2018 - Implantable Cardiac Defibrillators (ICDs)

[unless otherwise specified, the effective date is the date of service]

The Centers for Medicare & Medicaid Services (CMS) has released a change request that informs contractors that effective for claims with dates of service on and after February 15, 2018, CMS will cover Implantable Cardiac Defibrillators (ICDs) for the patient indications listed below:

  1. Patients with a personal history of sustained Ventricular Tachycardia (VT) or cardiac arrest due to Ventricular Fibrillation (VF).
  2. Patients with a prior Myocardial Infarction (MI) and a measured Left Ventricular Ejection Fraction (LVEF) ≤ 0.30.
  3. Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have New York Heart Association (NYHA) Class II or III heart failure, LVEF≤ 35%.
  4. Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF ≤ 35%, and been on optimal medical therapy for at least three (3) months.
  5. Patients with documented familial, or genetic disorders with a high risk of life-threatening tachyarrhythmia (sustained VT or VF), to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.
  6. Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, Elective Replacement Indicator (ERI), or device/lead malfunction.

For indications 2 - 5 above, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Social Security Act (the Act)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. NOTE: The shared decision making encounter may occur at a separate visit.

Exceptions to waiting periods for patients that have had a Coronary Artery Bypass Graft (CABG), or Percutaneous Coronary Intervention (PCI) with angioplasty and/or stenting within the past three (3) months, or had an MI within the past 40 days:

Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in NCD 20.4 for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated;

Replacement of ICDs: Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, ERI, or device/lead malfunction.

For patients that are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor becomes available, is determined by the local Medicare Administrative Contractors (MACs).

All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B Investigational Device Exemption (IDE) trials (42 CFR 405.201).

For NCDs prior to 2018, please visit the Medicare Coverage webpage on CMS.gov, opens new window that provides:

  1. A listing of all NCDs including both pending and closed coverage determinations
  2. All national coverage analyses (NCAs) and final decision memos
  3. An index of LCDs
  4. Ability for users to subscribe to the CMS Coverage Listserv and receive weekly notifications when national coverage documents are updated, such as NCAs and NCDs. Listserv subscribers also receive special updates, including CMS announcements of new topics opened for national decision, decision memo postings and final technology assessment (TA) report postings
  5. All email coverage updates sorted by year
  6. A searchable NCD database
  7. Staff name and email links for each coverage topic so that interested individuals can send questions and provide feedback