Member Notification of Medicare National Coverage Determination (NCD)

What is this notice?

From time to time, the federal agency that runs Medicare announces new information about coverage under the program. The Medicare program requires Blue KC to notify its members of this information on our website.

What does this mean to me?

This is an announcement of new coverage rules. The new rules do not affect all members.

What are the new coverage rules?

  • The Centers for Medicare & Medicaid Services (CMS) will cover FDA approved vagus nerve stimulation (VNS) devices for certain patients with treatment resistant depression (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 one year, possibly 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. (Posted 2/15/2019)
    Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (CAG-00313R2)

  • The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when the following requirements are met: (Posted March 16, 2018)
     1. 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).
     2. The diagnostic laboratory test using NGS must have:
    • 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.
    Decision memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

  • The Centers for Medicare & Medicaid Services (CMS) has made changes to the coverage criteria for implantable cardioverter defibrillators (ICDs.) (Posted 2/15/2018)
    These changes include:
    • addition of diagnostic tests that can evaluate conditions appropriate for treatment with ICD
    • requirement for optimal medication therapy for at least 3 months for certain conditions
    • requirement for a patient shared decision making interaction prior to implantation of a device for certain patients.
    • provides exceptions to waiting periods for certain patients
    • ends the requirement for data collection
    Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

  • The Centers for Medicare & Medicaid Services (CMS) will cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD) when provided in a qualified SET program and the beneficiary’s condition meets certain criteria. (Posted May 25, 2017)
    Decision memo for Supervised Exercise Therapy for Peripheral Artery Disease (CAG-00449N)

  • The Centers for Medicare and Medicaid Services (CMS) has amended its previous National Coverage Determination (NCD) for HBO therapy by removing Section C from the NCD, which previously considered the application of topical oxygen for chronic wounds as nationally non-covered. The coverage of topical oxygen for this purpose will be determined by the local Medicare Administrative Contractors. (Posted 4/3/2017)
    Decision Memo for Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Oxygen)

  • The Centers for Medicare & Medicaid Services (CMS) has signaled its intent to cover leadless pacemakers through Coverage with Evidence Development (CED). Medicare covers leadless pacemakers when procedures are performed in certain FDA approved studies. Medicare will cover, in CMS-approved prospective long-term studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:
    - An associated ongoing FDA approved post-approval study; or
    - Completed an FDA post-approval study (Posted January 18, 2017)
    Decision Memo for Leadless Pacemakers (CAG-00448N)

  • The Centers for Medicare & Medicaid Services (CMS) has determined that percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. Medicare will cover PILD procedures in certain cases when provided in a CMS-approved prospective and longitudinal clinical research study. (Posted December 7, 2016)
    Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)

  • Effective 9/28/2016, Medicare will cover a screening test for hepatitis B (HBV) infection in nonpregnant adolescents and adults without symptoms of the infection who are determined by their primary care providers to be at high risk. In addition, Medicare has determined that repeated screening would be appropriate annually only for beneficiaries with continued high risk who do not receive the hepatitis B vaccine. (Posted 09/28/2016)
    Decision Memo for Screening for Hepatitis B (HBV) Infection

  • Decision Memo for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N)
    The Centers for Medicare & Medicaid Services (CMS) is not issuing a National Coverage Determination (NCD) at this time on gender reassignment surgery for Medicare beneficiaries with gender dysphoria because the clinical evidence is inconclusive for the Medicare population. For Medicare beneficiaries enrolled in Medicare Advantage (MA) plans, the initial determination of whether or not surgery would be reasonable and necessary will be made by the MA plans. (posted on 8/30/2016)
    Decision Memo for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N)

  • Effective for services performed on or after 4/13/2015, Medicare will cover annual voluntary HIV screening for beneficiaries age 15 to 65 and for beneficiaries younger than 15 and older than 65 who are at increased risk for HIV infection. Medicare will cover a maximum of 3 voluntary screenings for pregnant beneficiaries under certain conditions. (Posted 3/7/2016)
    National Coverage Determination (NCD) for Screening for the Human Immunodeficiency Virus (HIV) Infection (210.7)

  • Effective for services performed on or after 7/9/2015, Medicare will cover testing for Human Papillomavirus (HPV) once every 5 years for beneficiaries without symptoms, aged 30 to 65 years, when performed with the Pap smear test for cervical cancer. (Posted 3/7/2016)
    National Coverage Determination (NCD) for Screening for Cervical Cancer with Human Papillomavirus (HPV) (210.21)

  • Medicare covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation when the device has received FDA premarket approval and the beneficiary’s condition meets certain requirements. (Posted 2/8/2016)
    Decision Memo for Percutaneous Left Atrial Appendage (LAA) closure therapy (CAG-00445N)

  • Medicare is expanding national coverage for allogeneic hematopoietic stem cell transplantation (HSCT) for three separate medical conditions: Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease. This coverage applies to certain beneficiaries who are participating in approved clinical studies. (Posted January 27,2016)
    Decision memo for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease) (CAG-0044R)

What should I do if I have questions?

If you have a question about these changes or about how Blue Medicare Advantage will cover these benefits, please contact us.

Y0126_19-556_ITKC - Last updated 12/20/2018