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Transmittals 217 and 4546 are being rescinded and replaced by Transmittals 10179, one for each manual, dated June 10, 2020.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 Dec. 1, 2020: CMS notified their 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 the CMS website, opens new window its process for organizations to apply for CMS approval to be designated as a credentialing organization for VAD facilities and a list of approved credentialing organizations, approved standard versions and credentialed facilities.

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

International Classification of Diseases, Tenth Revision (ICD-10) and other coding revisions to NCDs

Effective May 17, 2021: CMS provided a maintenance update to the ICD-10 conversions and other coding updates specific to NCDs

Transmittal 10624 was rescinded and replaced by Transmittal 10804 to make several changes to Business Requirement (BR) 12124.2 and NCD 90.2 Next Generation Sequencing (NGS).

Those changes are:

  • Retain previously deleted codes for 1 year, and then delete following provider education
  • Add 3 current procedural terminology codes and corresponding ICD-10 diagnosis codes
  • Add 1 ICD-10 diagnosis code
  • Delete 12 expired ICD-10 diagnosis codes

This correction also adds BR 12124.2.1 and revised the NCD 90.02 NGS spreadsheet. All other information remains the same.

Effective June 2, 2021: CMS provided a maintenance update to the ICD-10 conversions and other coding updates specific to NCDs

For this update, Transmittal 10804 was rescinded and replaced by Transmittal 10832 to modify the spreadsheets for NCD 90.2, Next Generation Sequencing, and 230.9, Cryosurgery of Prostate.

NCD spreadsheets are located at the CMS website, opens new window.

CMS would like to clarify that coding (as well as payment) is a separate and distinct area of the Medicare program from coverage policy/criteria.

CMS notes:

The translations from ICD-9 to ICD-10 are not consistent 1-to-1 matches, nor are all ICD-10 codes appearing in a complete General Equivalence Mappings (GEMs)* guide or other mapping guides appropriate when reviewed against individual NCD policies.

*GEMs is no longer provided by CMS as of Oct. 1, 2019.

For NCDs made more than 18 months ago, 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