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National Coverage Determinations

National Coverage Determinations

(Updated November 2017)
The Centers for Medicare & Medicaid Services (CMS) sometimes change the coverage rules that apply to an item or service midyear. When this happens, CMS issues a National Coverage Determination (NCD). It tells us:

  • Which benefits and services are covered
  • Which benefits and services are changing
  • How much Medicare will pay for an item or service

CDPHP® Medicare Choices is required to notify members about any NCDs that affect our plan benefits via this website.

If you have any questions about your CDPHP Medicare Choices coverage, please contact Member Services at the number on your ID card.

See our NCD notices below.

 

Leadless Pacemakers
Effective: January 18, 2017

CMS covers leadless pacemakers as part of clinical research studies. The study must meet certain criteria and be approved by CMS and the Food and Drug Administration (FDA).
The leadless pacemaker eliminates some causes of complications with traditional pacing systems.
This summarizes CMS transmittal 201.

National Coverage Determination (NCD) for Leadless Pacemakers (20.8.4)

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
Effective: 05/25/2017

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD). Up to 36 sessions over a 12 week period are covered if all of the following components of a SET program are met. For calendar years 2017 and 2018 only, original fee-for-service Medicare will pay for reasonable and necessary items and services obtained by beneficiaries enrolled in MA plans.

Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

 

Screening for Hepatitis B Virus (HBV) Infection
Effective: 09/28/2016

The Centers for Medicare & Medicaid Services (CMS) has reviewed the updated US Preventive Services Task Force (USPSTF) guidance on screening for Hepatitis B Virus (HBV) infection. Medicare will cover HBV screening when ordered by a primary care provider for members who meet one of the following conditions:

  • Asymptomatic, non-pregnant adolescents and adults at high risk for HBV infection
  • HBV screening for pregnant women
This summarizes CMS transmittal 195

Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N

Percutaneous Left Atrial Appendage Closure
Effective:
February 8, 2016

Description: CMS posted a final decision memo for percutaneous left atrial appendage closure (LAAC). CMS will provide national coverage for percutaneous LAAC under Medicare’s Coverage with Evidence Development (CED) program. A national non-coverage determination will remain for percutaneous LAAC outside of a clinical trial.

Medicare’s CED program allows for coverage of items or services that are reasonable and necessary for research to support evidence development for technologies likely to show benefit for the Medicare population. The coverage decision memo allows for coverage of percutaneous LAAC for patients with non-valvular atrial fibrillation when all of the specified conditions for coverage are met. Patients must be enrolled in a CMS-approved prospective national registry, and the implanted device must be FDA approved for patients with non-valvular atrial fibrillation.

The Watchman LAAC device is the only device that is FDA approved for LAAC closure in patients with non-valvular atrial fibrillation. The FDA-approved indication is to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

  • Are at increased risk for stroke and systemic embolism and are recommended for anticoagulation therapy
  • Are deemed by their physicians to be suitable for warfarin
  • Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

The CMS decision memo notes that devices other than the FDA-approved Watchman that are either not FDA approved or are used off-label for LAAC (Lariat) do not have adequate data to demonstrate a health benefit and could have the potential for harm. All approved registries will be posted on the CED website

Visit the CMS website for more details.

Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease)
Effective: January 27, 2016
Description: CMS posted a final decision that modifies the NCD for allogenic hematopoietic stem cell transplantation to include coverage for treatment of multiple myeloma, myelofibrosis, and sickle cell disease. This came from a request for reconsideration and expansion of the prior NCD, which allowed for coverage of stem cell transplantation only for treatment of leukemia, aplastic anemia, severe combined immunodeficiency disease, myelodystplastic syndromes, and Wiskott-Aldrich syndrome. Coverage will be available for patients who meet coverage criteria and are participating in an approved prospective clinical study.

Visit the CMS website to learn more.

 

HIV Screening
Effective: April 13, 2015
Description:
In keeping with the recommendations of the United States Preventive Services Task Force (USPSTF), Medicare now covers one-time HIV infection screening for all individuals between the ages of 15 and 65 years, regardless of perceived risk. Such screening is already covered annually for Medicare beneficiaries in that age group who are at increased risk for HIV, and up to three times per pregnancy.

Low-Dose CT Screening for Lung Cancer
Effective: February 5, 2015
Description: Medicare now covers preventive lung cancer screening with low-dose computed tomography (LDCT) once per year for beneficiaries age 55 to 77 who meet the following criteria:

  • Do not currently display lung cancer symptoms;
  • Are current smokers or have quit smoking within the previous 15 years;
  • Have a tobacco smoking history of at least 30 “pack years” (an average of one pack a day for 30 years); and
  • Have a written order from a physician or other qualified practitioner documenting that the member meets the above criteria, has been counseled on the importance of tobacco abstinence, and is willing to go ahead with treatment for lung cancer, if found.

Coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening.

Visit the CMS website to learn more.

 

Cologuard™
Effective: October 9, 2014
Description: Cologuard™, a stool DNA screening for colorectal cancer, will be covered every three years for Medicare beneficiaries meeting the following criteria:

  • Age 50 to 85 years
  • Showing 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 colorectal cancer or inflammatory bowel disease and no family history of colorectal cancers).

Visit www.cms.gov for more information.

Transcatheter Mitral Valve Repair
Effective: August 7, 2014
Description: CMS released a determination on transcatheter mitral valve repair (TMVR). CMS will cover TMVR for the treatment of significant symptomatic mitral regurgitation if performed by an interventional cardiologist and/or a cardiothoracic surgeon, using a device specifically approved by the Food and Drug Administration (FDA) for TMVR, and the beneficiary is enrolled in a prospective, national, audited registry. The MitraClip Mitral Valve Repair System (Abbott Vascular Inc.) is currently the only eligible device.

Visit the CMS website to learn more.

Screening for Hepatitis C Virus
Effective:
June 2, 2014
Description: CMS has concluded that screening for Hepatitis C Virus (HCV), consistent with the grade B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability. CDPHP already covers this testing when ordered by the member’s primary care practitioner and performed by an eligible Medicare provider, and the following apply:

  • The adult patient is at high risk for Hepatitis C Virus infection, meaning a history of illicit injection drug use and/or received a blood transfusion prior to 1992. Repeat screening is covered annually for high-risk individuals with continued illicit injection drug use subsequent to a prior negative screening test.
  • A single screening test is covered for those born from 1945 through 1965, regardless of whether they meet the high-risk criteria.

Visit the CMS website to learn more.

Intensive Cardiac Rehabilitation
Effective: May 6, 2014
Description: The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to expand the intensive cardiac rehabilitation (ICR) benefit to include the Benson-Henry Institute Cardiac Wellness Program. Previously, only the Pritikin Program and the Ornish Program met the requirements for ICR. This did not require a change to current CDPHP policy.

Visit the CMS website for more details.

Cardiac Rehabilitation
Effective:
February 18, 2014
Description: CMS has expanded coverage for cardiac rehabilitation services to beneficiaries with stable, chronic heart failure. “Chronic heart failure” is considered present in patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms, despite being on optimal heart failure therapy for at least six weeks. To be considered “stable,” the patient must not have not had a major cardiovascular hospitalization or procedure within the previous six weeks nor reasonably be expected to undergo a major cardiovascular hospitalization or procedure within the next six months.

Visit the CMS website to learn more.

Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (LSS)
Effective:
January 9, 2014
Description: CMS has determined that this procedure is not reasonable and necessary but may be covered by Medicare only when provided for beneficiaries with LSS who are enrolled in an approved clinical trial. This determination will not result in any changes to current CDPHP policy.

Visit the CMS website for more details.

 

CDPHP is an HMO with a Medicare contract. Enrollment in CDPHP Medicare Choices depends on contract renewal.

Y0019_18_4922 Approved Last updated 12/15/17

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