National Coverage Determinations

The Centers for Medicare and Medicaid (CMS) periodically releases changes to services covered by Medicare through National Coverage Determinations (NCD). Health plans are required to notify members of these changes. A NCD is a nationwide determination by CMS on whether an item or service is medically necessary. Please check back often to review the most recent updates on Medicare covered services. The full text of these updates may be found here: national coverage annual report

Cochlear Implantation

Effective September 26, 2022, The Centers for Medicare & Medicaid Services (CMS) is expanding coverage by 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.

CMS may also provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed above when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?proposed=N&NCAId=306.

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Effective April 8, 2022, Medicare has determined to cover under a coverage with evidence development (CED) Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s or mild Alzheimer’s dementia, both with confirmed presence of amyloid beta pathology consistent with Alzheimer’s.

The coverage criteria for this treatment are the following:

• Monoclonal antibodies directed against amyloid that are approved by FDA for the treatment of Alzheimer’s based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application.
• Monoclonal antibodies directed against amyloid that are approved by FDA for the treatment of Alzheimer’s based upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS approved prospective comparative studies. Study data for CMS approved prospective comparative studies may be collected in a registry.
• The study is approved by CMS and includes a specific analysis plan, answers certain questions, and adheres to the standards of scientific integrity that have been identified by the Agency for Healthcare Research and Quality.

Monoclonal antibodies directed against amyloid indicated for the treatment of Alzheimer’s are covered when furnished according to the FDA approved indication in National Institutes of Health (NIH)-supported trials.If you receive a beta amyloid PET scan as part of the protocol for the CMS approved study or NIH-supported trial, the PET scan may also be covered by Medicare. Please note that there is a once per lifetime limit for this coverage.

Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s provided outside of a FDA approved randomized controlled trial, CMS approved studies, or studies supported by the NIH, are not covered.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?proposed=N&NCAId=305.

Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Effective February 10, 2022, Medicare has determined to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following criteria are met:

• Beneficiary eligibility criteria:
  • Age 50 – 77 years;
  • Asymptomatic (no signs or symptoms of lung cancer);
  • Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
  • Current smoker or one who has quit smoking within the last 15 years; and
  • Receive an order for lung cancer screening with LDCT.
• Counseling and Shared Decision-Making Visit
  • Before the beneficiary’s first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets all of the following criteria, and is appropriately documented in the beneficiary’s medical records:
  • Determination of beneficiary eligibility;
  • Shared decision-making, including the use of one or more decision aids;
  • Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; and
  • Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.
• Reading Radiologist Eligibility Criteria
  • For purposes of Medicare coverage of lung cancer screening with LDCT, the reading radiologist must have board certification or board eligibility with the American Board of Radiology or equivalent organization.
• Radiology Imaging Facility Eligibility Criteria
  • For purposes of Medicare coverage, lung cancer screening with LDCT must be furnished in a radiology imaging facility that utilizes a standardized lung nodule identification, classification and reporting system.

This decision 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, and reduces the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry). To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?proposed=N&NCAId=304.

Transvenous (Catheter) Pulmonary Embolectomy

Effective October 28, 2021, Medicare will allow Plans to make individual coverage decisions on the transvenous (Catheter) Pulmonary Embolectomy.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?proposed=N&NCAId=303.

Home use of home oxygen and use of oxygen to treat cluster headache

Effective September 27, 2021, Medicare will allow Plans to make individual coverage decisions on the use of home oxygen and oxygen equipment in order to treat cluster headaches. In addition, Medicare is also expanding the patient access to oxygen and oxygen equipment in the home, and to permit Plans to cover the use of home oxygen and oxygen equipment in order to treat cluster headache and other acute conditions.

Initial claims for oxygen therapy for hypoxemic patients must be based on the results of a clinical test that has been ordered and evaluated by the treating practitioner.

• Such a test is usually in the form of a measurement of the partial pressure of oxygen (PO2) in arterial blood.
  • A measurement of arterial oxygen saturation obtained by ear or pulse oximetry, however, is also acceptable when ordered and evaluated by the treating practitioner and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services.
    • A durable medical equipment (DME) supplier is not considered a qualified provider or supplier of laboratory services for purposes of this NCD.
      • This prohibition does not extend to the results of blood gas tests conducted by a hospital certified to do such tests.
    • When the arterial blood gas and the oximetry studies are both used to document the need for home oxygen therapy and the results are conflicting, the arterial blood gas study is the preferred source of documenting medical need.

Required qualifying arterial blood gas or oximetry studies must be performed at the time of need.

• The time of need is defined as during the patient’s illness when the presumption is that the provision of oxygen in the home setting will improve the patient’s condition.
  • For an inpatient hospital patient the time of need is within 2 days of discharge.
  • For those patients whose initial oxygen prescription does not originate during an inpatient hospital stay, the time of need is during the period when the treating practitioner notes signs and symptoms of illness that can be relieved by oxygen in the patient who is to be treated at home.

Patients exhibiting hypoxemia are defined using the clinical criteria below:

• Group 1:
  • An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, taken at rest, breathing room air; or
  • An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, taken during sleep for a patient who demonstrates an arterial PO2 at or above 56 mm Hg, or an arterial oxygen saturation at or above 89%, while awake; or a greater than normal fall in oxygen level during sleep (a decrease in arterial PO2 more than 10 mm Hg, or decrease in arterial oxygen saturation more than 5%) associated with symptoms or signs reasonably attributable to hypoxemia (e.g., impairment of cognitive processes and nocturnal restlessness or insomnia). In either of these cases, coverage is provided only for use of oxygen during sleep, and then only one type of unit will be covered. Portable oxygen, therefore, would not be covered in this situation; or,
  • An arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88%, taken during exercise [defined as either the functional performance of the patient or a formal exercise test], for a patient who demonstrates an arterial PO2 at or above 56 mm Hg, or an arterial oxygen saturation at or above 89%, during the day while at rest.
  • In this case, supplemental oxygen is provided for during exercise if the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.
• Group 2:
  • Coverage is available for patients whose arterial PO2 is 56-59 mm Hg or whose arterial blood oxygen saturation is 89%, if there is:
    • Dependent edema suggesting congestive heart failure; or,
    • Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram (EKG), or "P" pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVFL; or,
    • Erythrocythemia with a hematocrit greater than 56%.
  • In reviewing the arterial PO2 levels and the arterial oxygen saturation percentages specified above, the Plan must take into account variations in oxygen measurements that may result from such factors as the patient's age, the patient’s skin pigmentation, the altitude level, or the patient's decreased oxygen carrying capacity.

In addition, Medicare will not cover oxygen and home oxygen equipment in the following circumstances:

• Angina pectoris in the absence of hypoxemia. This condition is generally not the result of a low oxygen level in the blood, and there are other preferred treatments; or,
• Breathlessness without cor pulmonale or evidence of hypoxemia. Although intermittent oxygen use is sometimes prescribed to relieve this condition, it is potentially harmful and psychologically addicting; or,
• Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities. There is no evidence that increased PO2 improves the oxygenation of tissues with impaired circulation; or,
• Terminal illnesses unless they affect the ability to breathe.

The Plan may determine reasonable and necessary coverage of home oxygen and oxygen equipment for patients who are not described in the above text. Initial coverage for patients with other conditions may be limited to the shorter of 120 days or the number of days included in the practitioner prescription. Oxygen coverage may be renewed if medically necessary.

The Plan may allow beneficiaries who are mobile in the home and would benefit from the use of a portable oxygen system in the home to qualify for coverage of a portable oxygen system either (1) by itself, or, (2) to use in addition to a stationary oxygen system.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=301.

Screening for Colorectal Cancer - Blood-Based Biomarker Tests

Effective January 19, 2021, Medicare will cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

1. The patient is:
   1. Age 50-85 years, and;
   2. Asymptomatic (no signs or symptoms of colorectal disease including lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and;
   3. At average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, and no family history of the above).
2. The blood-based biomarker screening test must have all of the following:
   1. FDA market authorization with an indication for colorectal cancer screening; and
   2. 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 (a colonoscopy at this time), based on the pivotal studies included in the FDA labeling.

Please note that the current available Epi proColon® test does not meet the criteria and will not be covered by Medicare.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=299.

Mitral Valve Transcatheter Edge-to-Edge Repair (TEER)

Effective January 19, 2021, Medicare is replacing the term Transcatheter Mitral Valve Repair (TMVR) with mitral valve Transcatheter Edge-to-Edge Repair (TEER) for the treatment of functional mitral regurgitation (MR) and degenerative MR through Coverage with Evidence Development (CED).

CMS will cover TEER of the mitral valve under CED as follows:

1. For the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or the treatment of significant symptomatic degenerative MR when furnished according to an FDA-approved indication and when all of the following conditions are met:
   1. The procedure is furnished with a mitral valve TEER system that has received FDA premarket approval (PMA).
   2. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary, and experienced team of appropriate medical professionals.
   3. Each patient’s suitability for surgical mitral valve repair, TEER, or palliative therapy must be evaluated, documented, and made available to other heart team members. Additional requirements are needed for patients with functional MR.
   4. An interventional cardiologist or cardiac surgeon from the heart team must perform the mitral valve TEER and an interventional echocardiographer from the heart team must perform transesophageal echocardiography during the procedure.
   5. Mitral valve TEERS must be furnished in a hospital with appropriate infrastructure and experience.
   6. The heart team and hospital are participating in a prospective, national, audited registry.
   7. The registry shall collect all data necessary and have a written executable analysis plan in place to address specific questions.
2. Mitral valve TEERs are covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills all of the following:
   1. An interventional cardiologist or cardiac surgeon must perform the mitral valve TEER and an interventional echocardiographer must perform transesophageal echocardiography during the procedure.
   2. As a written part of its protocol, the clinical research trail must critically evaluate specific questions at 12 months or longer follow-up.
   3. As a written part of its protocol, the clinical research study must critically evaluate not only each patient’s quality of life pre- and post-TEER, but must also address at least one of the following questions:
      1. What is the incidence of stroke?
      2. What is the incidence of mini-strokes?
      3. What is the incidence of major vascular events?
      4. What is the incidence of renal complications?
      5. What is the incidence of worsening MR?
      6. What is the change in quality of life after TEER?
      7. What is the change in the patient’s functional capacity after TEER?
   4. The clinical study must adhere to specific standards of scientific integrity and relevance to the Medicare population.

TEER of the mitral valve is not covered under the following circumstances:

CMS will consider published, peer-reviewed evidence periodically, following the effective date of this NCD and reconsider the policy when appropriate. The NCD will expire 10 years from the effective date if it is not reconsidered during that time. Upon expiration, coverage will be at the discretion of the Medicare Administrative Contractors (MACs).

To find out which studies have been approved by CMS, please visit
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TMVR.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=297.

Next Generation Sequencing (NGS) for Patients with Somatic (Acquired) and Germline (Inherited) Cancer

Effective January 27, 2020, Medicare will expand coverage of Next Generation Sequencing (NGS) for patients with cancer.

1. Germline (inherited) cancer
   

   CMS has determined that 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 all of the following requirements are met:

   1. The patient has:
      1. Ovarian or breast cancer; and
      2. A clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer, and
      3. A risk factor for germline (inherited) breast or ovarian cancer; and
      4. Not been previously tested with the same germline test using NGS for the same germline genetic content.
   2. The diagnostic laboratory test using NGS must have all of the following:
      1. Food and Drug Administration (FDA) approval or clearance; and
      2. Results provided to the treating physician for management of the patient using a report template to specify treatment options.

   In addition, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:

   • Any cancer diagnosis; and
   • A clinical indication for germline (inherited) testing of hereditary cancers; and
   • A risk factor for germline (inherited) cancer; and
   • Not been previously tested with the same germline test using NGS for the same germline genetic content.
   Central Health Medicare Plan will refer to Local Coverage Determinations in such cases.
2. Somatic (acquired) cancer
   

   CMS has also made the following clarifications regarding somatic cancer. CMS has determined that 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 all of the following requirements are met:

   1. The patient has:
      1. Either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
      2. Not been previously tested with the same test using NGS for the same cancer genetic content; and
      3. Decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
   2. The diagnostic laboratory test using NGS must have:
      1. Food and Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and
      2. An FDA-approved or –cleared indication for use in that patient’s cancer; and
      3. Results provided to the treating physician for management of the patient using a report template to specify treatment options.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=296.

Acupuncture for Chronic Low Back Pain

Effective January 21, 2020, Medicare will cover acupuncture for low back pain. Up to 12 visits in 90 days are covered for Medicare beneficiaries under the following circumstances:

1. For the purpose of this decision, chronic low back pain (cLBP) is defined as:
   1. Lasting 12 weeks or longer;
   2. Nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc. disease);
   3. Not associated with surgery; and
   4. Not associated with pregnancy.
2. An additional eight sessions will be covered by those patients demonstrating an improvement. No more than 20 acupuncture treatments may be administered annually.
3. Treatment must be discontinued if the patient is not improving or is regressing.

Physicians may furnish acupuncture in accordance with applicable state requirements. Physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); and
• Current, full, active, and unrestricted license to practice acupuncture in a State, Territory, or Commonwealth (i.e., Puerto Rico) of the United States, or District of Columbia.

Auxiliary personnel furnishing acupuncture must be under the appropriate level of supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist required by CMS regulations.

All types of acupuncture including dry needling for any condition other than cLBP are non-covered by Medicare. However, depending on your Plan, additional acupuncture visits based on the Plan’s supplemental benefit may be available.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=295.

Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers

Effective August 8, 2019, Medicare covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication, such as either for 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.

The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the above requirement(s) are not met.

Routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1 will be covered. For a link to NCD 310.1, please visit https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCAId=248&NCDId=1

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291.

Ambulatory Blood Pressure Monitoring (ABPM)

Effective July 2, 2019, Medicare covers ambulatory blood pressure monitoring (ABPM) for the diagnosis of hypertension in Medicare beneficiaries under the following circumstances:

1. Beneficiaries with suspected white coat hypertension, which is defined as an average office blood pressure of systolic blood pressure greater than 130 mm Hg but less than 160 mm Hg or diastolic blood pressure greater than 80 mm Hg but less than 100 mm Hg on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two blood pressure measurements taken outside the office which are <130 /80 mm Hg.
2. Beneficiaries with suspected masked hypertension, which is defined as average office blood pressure between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure on two separate clinic/office visits with at least two separate measurements made at each visit and with at least two blood pressure measurements taken outside the office which are ≥130/80 mm Hg.

ABPM devices must be:

• capable of producing standardized plots of blood pressure measurements for 24 hours with daytime and night-time windows and normal blood pressure bands demarcated;
• provided to patients with oral and written instructions and a test run in the physician’s office must be performed; and
• interpreted by the treating physician or treating non-physician practitioner

For eligible patients, ABPM is covered once per year.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=294.

Transcatheter Aortic Valve Replacement (TAVR)

Effective June 21, 2019, Medicare covers Transcatheter Aortic Valve Replacement (TAVR) for the treatment of symptomatic aortic valve stenosis through Coverage with Evidence Development (CED).

CMS will cover TAVR for treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication when the following conditions are met:

1. The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system's FDA approved indication.
2. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. The heart team includes the following:
   
   1. Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
      
      1. independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
      2. documented and made available to the other heart team members the rationale for their clinical judgment.
   2. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.
3. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
4. TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
   
   1. On-site heart valve surgery and interventional cardiology programs,
   2. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
   3. Appropriate volume requirements per the applicable qualifications below:

   There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.

   • Qualifications to begin a TAVR program for hospitals without TAVR experience:
     
     • The hospital program must have the following:
       • ≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and;
       • ≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;
       • ≥ 2 physicians with cardiac surgery privileges, and;
       • ≥ 1 physician with interventional cardiology privileges, and;
       • ≥ 300 percutaneous coronary interventions (PCIs) per year
   • Qualifications to begin a TAVR program for heart teams without TAVR experience:
     
     • The heart team must include:
       • Cardiovascular surgeon with:
         • i.≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related; and,
       • Interventional cardiologist with:
         • Professional experience of ≥ 100 career structural heart disease procedures; or, ≥ 30 left-sided structural procedures per year; and,
         • Device-specific training as required by the manufacturer.
   • Qualifications for hospital programs with TAVR experience:
     • The hospital program must maintain the following:
       • ≥ 50 AVRs (TAVR or SAVR) per year including ≥ 20 TAVR procedures in the prior year ; or,
       • ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years; and,
       • ≥ 2 physicians with cardiac surgery privileges; and,
       • ≥ 1 physician with interventional cardiology privileges, and
       • ≥300 percutaneous coronary interventions (PCIs) per year; and,
5. The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant regulations relating to protecting human research subjects

TAVR is also covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that is approved. To find out which studies have been approved by CMS, please visit https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html. The requirements for the clinical study are as follows:

1. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
2. As a fully-described, written part of its protocol, the clinical research study must critically evaluate not only each patient's quality of life pre-and post-TAVR (minimum of 1 year), but must also address at least one of the following questions:
   
   1. What is the incidence of stroke?
   2. What is the rate of all-cause mortality?
   3. What is the incidence of new permanent pacemaker implantation?
   4. What is the incidence of transient ischemic attacks (TIAs)?
   5. What is the incidence of major vascular events?
   6. What is the incidence of acute kidney injury?
   7. What is the incidence of repeat aortic valve procedures?
3. The clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population:
   
   1. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.
   2. The rationale for the study is well supported by available scientific and medical evidence.
   3. The study results are not anticipated to unjustifiably duplicate existing knowledge.
   4. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.
   5. The study is sponsored by an organization or individual capable of completing it successfully.
   6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and /or services, and the use and eventual disposition of the collected data
   7. All aspects of the research study are conducted according to appropriate standards of scientific integrity.
   8. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.
   9. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
   10. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).
   11. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 12 months of the study’s primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).
   12. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
   13. The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=293.

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)

Effective February 15, 2019, Medicare covers FDA-approved vagus nerve stimulation (VNS) devices for 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 with the possibility of extending the study to a prospective longitudinal study when the trial has completed enrollment, and there are positive interim findings.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=292.

To find out which studies have been approved by CMS, please visit https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index.html and find the name of procedure listed in the left-hand side of the website

Magnetic Resonance Imaging (MRI)

Effective April 10, 2018, Medicare has determined that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member under certain circumstances.

CMS will be revising their previous NCD on MRI in the following manner:

• Revise language in section 220.2(C)(1) to remove the contraindication for Medicare coverage of MRI in a beneficiary who has an PM or ICD;
• Expand coverage to include CRT-P or CRT-D devices;
• Expand coverage for beneficiaries who have an FDA-approved PM, ICD, CRT-P, or CRT-D under 220.2(B)(3) of the NCD Manual as a Nationally Covered MRI indication.
• Expand coverage for beneficiaries with a PM, ICD, CRT-P or CRT-D device that do not have FDA labeling specific for an MRI with certain criteria;
• Remove the Coverage with Evidence Development requirement.

CMS are also finalizing changes to Section 220.2(B)(3) of the NCD Manual as described below:

220.2(B): Nationally Covered MRI and MRA Indications

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=289.

Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Effective February 15, 2018, Medicare will cover Next Generation Sequencing (NGS) as a diagnostic laboratory test when:

• Performed in a CLIA-certified laboratory;
• Ordered by a treating physician; and
• All of the following requirements are met:
  • 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 (such as therapeutic chemotherapy).
  • 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.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290.

Implantable Cardioverter Defibrillators

Effective February 15, 2018, Medicare will cover the use of implantable cardioverter defibrillators (ICDs or defibrillators) for the treatment of illness or injury or to improve the functioning of a malformed body member. The criteria for coverage includes:

• Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated:
  • An episode of sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with a heart attack and not due to a transient or reversible cause
  • An episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause.

• Patients with a prior heart attack and a measured left ventricular ejection fraction (LVEF) = 0.30. Patients must not have:
  • New York Heart Association (NYHA) classification IV heart failure;
  • Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting within the past 3 months; or
  • Had a heart attack within the past 40 days; or
  • Clinical symptoms and findings that would make them a candidate for coronary revascularization.

• Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have NYHA Class II or III heart failure, LVEF = 0.35. Additionally, patients must not have:
  • Had a CABG, or PCI with angioplasty and/or stenting within the past 3 months; or
  • Had a heart attack within the past 40 days; or
  • Clinical symptoms and findings that would make them a candidate for coronary revascularization.

• Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have NYHA Class II or III heart failure, LVEF = 0.35, been on optimal medical therapy (OMT) for at least 3 months. Additionally, patients must not have:
  • Had a CABG, or PCI with angioplasty and/or stenting within the past 3 months; or
  • Had a heart attack within the past 40 days; or
  • Clinical symptoms and findings that would make them a candidate for coronary revascularization.

• Patients with documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained ventricular tachycardia or ventricular fibrillation) to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.

• Patients with an existing defibrillator may receive a replacement if it is required due to the end of the battery life, elective replacement indicator, or device/lead malfunction.

For each of the groups listed above, the following criteria must also be met:

• Patients must be clinically stable

• LVEF must be measured by echocardiography, nuclear medicine imaging, cardiac MRI, or catheter angiography;

• Patients must not have:
  • Significant, irreversible brain damage; or
  • Any disease, other than cardiac disease (such as cancer, renal failure, or liver failure) associated with a likelihood of survival less than 1 year; or
  • Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.

Exceptions to waiting periods for patients that have had a CABG or PCI with angioplasty and/or stenting within the past 3 months or had a heart attack within the past 40 days:

• Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers and who meet the criteria above for a defibrillator may receive the combined device in one procedure at the time the pacemaker is clinically indicated;
• Replacement of defibrillators: Patients with an existing defibrillator may receive a replacement if it is required due to the end of battery life, elective replacement indicator, or device/lead malfunction.

Other indications:

• For patients who are candidates for heart transplantation on the United Network for Organ Sharing transplant list awaiting a donor heart, coverage of defibrillators, as with cardiac resynchronization therapy, as a bridge to transplant to prolong survival until a donor becomes available will be determined on a case by case basis.
• All other indications for defibrillators not currently covered in accordance with this decision may be covered under Category B IDE trials.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287.

Leadless Pacemakers

Effective January 18, 2017, Medicare will cover leadless pacemakers when procedures are performed in FDA approved studies and also in prospective longitudinal studies where leadless pacemakers that are used in accordance with FDA approved label for devices that have either:

• An associated ongoing FDA approved post-approval study; or
• Completed an FDA post-approval study.

Each study must be approved by CMS and must address the following research questions:

• What are the peri-procedural and post-procedural complications of leadless pacemakers?
• What are the long term outcomes of leadless pacemakers?
• What are the effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=285.
Approved studies will be posted in the following link: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index.html

Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)

Effective December 7, 2016, Medicare will cover through prospective longitudinal studies Percutaneous Image-Guided Lumbar Decompression (PILD) using an FDA-approved/cleared device, that successfully completed a CMS-approved RCT that met the criteria listed in Section 150.13 of the NCD manual. In addition, the CMS-approved prospective longitudinal study must answer at least one of the following questions:

• Does PILD provide a clinically meaningful improvement of function (e.g., reduced acute and post-acute hospitalizations, nursing home care or inpatient rehabilitation services) and/or quality of life in Medicare beneficiaries with Lumbar Spinal Stenosis (LSS) compared to other treatments?
• Does PILD provide a clinically meaningful reduction in pain (e.g., as measured by class, dose, duration of prescription pain medication use) in Medicare beneficiaries with LSS compared to other treatments?
• Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services (e.g., repeat PILD procedures, other interventions and surgical treatments), compared to other treatments?

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284.
Approved studies can be found in the following link: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/PILD.html

Screening for Hepatitis B Virus (HBV) Infection

Effective September 28, 2016, Medicare will now cover screening for Hepatitis B Virus (HBV) infection with the appropriate FDA approved tests when ordered by your PCP for beneficiaries who meet either of the following 2 conditions:

• Adolescents and adults at high risk for HBV infection and are not currently pregnant or have any symptoms.
  • High risk includes:
    • those who are born in countries and regions with a high prevalence of HBV infection,
    • U.S.-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infections
    • HIV-positive persons
    • Men who have sex with men
    • Injection drug users
    • Household contacts or sexual partners of persons with HBV infection
  • In addition, CMS has determined that repeated screening would be appropriate annually only for members with continued high risk who do not receive hepatitis B vaccination.
• At the first prenatal visit for pregnant women and then rescreening at the time of delivery for those with new or continuing risk factors.
  • In addition, CMS has determined that screening during the first prenatal visit would be appropriate for each pregnancy, regardless of previous hepatitis B vaccination or previous negative hepatitis B surface antigen (HBsAg) test results.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=283

Percutaneous Left Atrial Appendage (AA) Closure Therapy

Effective February 8, 2016, Medicare will now cover percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) with the following 2 conditions:

• LAAC devices are covered when the device has received FDA Premarket Approval for that device’s FDA-approved indication and meet all of the conditions specified below:
  • You must have:
    • At least 2 of the following conditions:
      • congestive heart failure,
      • high blood pressure
      • over the age of 75
      • diabetes
      • a prior stroke, mini-stroke or obstruction of the blood vessel due to a blood clot
    • or at least 3 of the following conditions:
      • congestive heart failure
      • high blood pressure
      • age 65 or older (if older than 75, then you need only 1 other condition to qualify)
      • diabetes
      • a prior stroke, mini-stroke or obstruction of the blood vessel due to a blood clot (if you have had a history of stroke, mini-stroke or blood clot, then you need only 1 other condition to qualify)
      • vascular disease
      • if you are female
  • You must first consult with an independent physician on oral anticoagulation prior to the procedure.
  • This physician must conclude that you will be able to take short-term regimen of warfarin, such as Coumadin, but be unable to take a long term oral anticoagulation.
  • The procedure must be take place in a hospital with an established structural heart disease and/or electrophysiology program and be performed by a qualified medical professional.
  • You must be enrolled with a Medicare-approved registry that studies the outcomes of the procedure for at least 4 years.
• LAAC devices are covered for NVAF patients not included in the previous section when performed within an FDA-approved randomized controlled trial that is also approved by Medicare.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease

Effective January 27, 2016, Medicare will expand its coverage of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) to now cover Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease. Allogeneic HSCT will be covered by Medicare for those who participate in an approved clinical study. In addition, you must have the following:

• For Multiple Myeloma, you must have Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma.
• For Myelofibrosis, you must have Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary myelofibrosis.
• For Sickle Cell Disease, you must have severe, symptomatic sickle cell disease.

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=280

NaF-18 PET Scans to Identify Bone Metastasis of Cancer

Effective December 15, 2015, Medicare will no longer cover F-18 Sodium Fluoride (NaF-18) Positron Emission Tomography (PET) scan to identify whether cancer from a primary organ has spread to the bone. Medicare will continue to cover NaF-18 PET Scans for clinical studies for up to 24 months if any of the below criteria is met. The extension allows more research done to answer the question of: does PET imaging lead to:

• A change in patient management to more appropriate palliative care; or
• A change in patient management to more appropriate curative care; or
• Improved quality of life; or
• Improved survival

To read the decision from CMS, please visit https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=279

Speech Generating Devices

Effective July 29, 2015, Medicare has expanded the coverage for speech generating devices are Durable Medical Equipment to cover any speech generating devices that allow speech in the form of both audible and written communications – including the generation of written messages (such as email and text messages), and the capability to interface electronically with a telephone to deliver speech via phone messages to individuals who are not within hearing distance of the user. The speech generating device may be software. The speech generating device no longer needs to be "dedicated" to speech generation so long as the speech generating device is limited to use by patients with severe speech impairment, and is primarily used for the purpose of generating speech.
Please note that computers and tablets in general are not considered DME and Medicare will not cover internet or phone services.

To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=26#final

Screening for the Human Papillomavirus (HPV)

Effective July 9, 2015, Medicare will cover FDA approved testing for HPV once every five years as a part of the Part B preventive service benefit when tested alongside pap smear testing for the purpose of screening for HPV as an early indicator of cervical cancer. The tests must be ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who do not have any symptoms of HPV and are between the ages of 30 and 65.

To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=278

Screening for the Human Immunodeficiency Virus (HIV) Infection

Effective April 13, 2015, Medicare will cover screening for HIV when they are conducted with approved tests, are used appropriately, and are ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet one of the following conditions:

• Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.
• Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection, as defined at the link below.
• A maximum of three, voluntary HIV screenings of pregnant Medicare beneficiaries: (1) when the diagnosis of pregnancy is known, (2) during the third trimester, and (3) at labor, if ordered by the woman’s clinician.

To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=276

Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Effective February 5, 2015, Medicare will cover lung cancer screening with Low Dose Computed Tomography (LDCT) once per year for Medicare beneficiaries who meet all of the following criteria:

• asymptomatic (no signs or symptoms of lung cancer);
• age 55-77,
• either current smokers or have quit smoking within the last 15 years;
• they have a tobacco smoking history of at least 30 "pack years" (an average of one pack a day for 30 years); and
• they receive a written order from a physician or qualified non-physician practitioner that meets certain requirements.

Medicare coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening. To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274

Microvolt T-wave Alternans (MTWA)

Effective January 13, 2015, CMS has removed a previously implemented NCD, which had stated that microvolt T-wave alternans (MTWA) with the modified moving average (MMA) method would not be nationally covered by Medicare. With this update, the national non-coverage of MTWA using the MMA method will be removed. Instead, Medicare coverage of this procedure will be determined by the local contractors. To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=275

Removal of NCDs effective 12/18/14

Effective December 18, 2014, CMS has removed the following 7 NCDs from the NCD manual:

• 50.6 - Tinnitus masking
• 160.4 - Stereotactic Cingulotomy as a Means of Psychosurgery
• 160.6 - Carotid Sinus Nerve Stimulator
• 160.9 - Electroencephalographic (EEG) Monitoring During Open-Heart Surgery
• 190.4 - Electron Microscope
• 220.7 - Xenon Scan
• 220.8 - Nuclear Radiology Procedure

When an NCD is removed, local Medicare contractors will determine whether coverage for these specific items or services is reasonable and necessary. Coverage is no longer guaranteed under Medicare. To read the decision from CMS, please visit http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=29

Invalidation of NCD 140.3 – Transsexual Surgery

Effective May 30, 2014 (with an implementation date of June 29, 2014), CMS has invalidated and removed NCD 140.3 - Transsexual Surgery. This NCD had stated that transsexual surgery is not covered by Medicare because it is experimental and has high risk of complications. The provisions/reasoning of NCD 140.3 may no longer be used as a basis for denying claims for transsexual surgeries. Now, local contractors and adjudicators will consider whether any Medicare claims for these services are reasonable and necessary and should be covered. To read the decision from CMS, please visit https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R169NCD.pdf

Screening for Colorectal Cancer - Stool DNA Testing

Effective October 9, 2014, Medicare Part B will cover the Cologuard test once every three years for beneficiaries who meet all of the following criteria:

• Age 50 to 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), and
• 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).

Screening for Hepatitis C Virus (HCV) in Adults

Effective June 2, 2014, CMS will cover screening for hepatitis C virus consistent with the grade B recommendations by the USPSTF for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Medicare Part A or enrolled under Part B.

Cardiac Rehabilitation Programs for Chronic Heart Failure

Effective for dates of service on and after February 18, 2014, Medicare covers cardiac rehabilitation services to beneficiaries with stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks.

Percutaneous image-guided lumbar decompression for lumbar spinal stenosis

Effective for claims with dates of service on or after January 9, 2014, PILD is covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) through Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study the necessary criteria.

Artificial Hearts and Related Devices

Effective October 30, 2013, an artificial heart for bridge-to-transplantation (BTT) and an artificial heart for destination therapy (DT), for services performed on or after May 1, 2008, are covered when performed under coverage with evidence development (CED) when a clinical study meets all of the criteria listed below. The clinical study must address at least one of the following questions:

• Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
• What will be the average time to device failure when the device is made available to larger numbers of patients?
• Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?

Ventricular Assist Devices

Effective October 30, 2013, VADs used for support of blood circulation post-cardiotomy and VADs used for bridge to transplant are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA-approved labeling instructions. VADs used for destination therapy (DT) are covered only if they have received approval from the FDA for that purpose.

The VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure) who are not candidates for heart transplantation at the time of VAD implant, and meet the following conditions:

• Have failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope-dependent for 14 days; and,
• Have a left ventricular ejection fraction (LVEF) < 25%; and,
• Have demonstrated functional limitation with a peak oxygen consumption of < 14 ml/kg/min unless balloon pump- or inotrope-dependent or physically unable to perform the test.

Facilities currently credentialed by the Joint Commission for placement of VADs as DT must have the beneficiaries receiving VADs for DT managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.

Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease

Effective September 27, 2013, Medicare will only allow coverage for PET Aß imaging (one PET Aß scan per patient) through coverage with evidence development (CED) to: (1) develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or (2) resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia (FTD) versus AD) where the use of PET Aß imaging appears to improve health outcomes, when the patient is enrolled in an approved clinical study under CED.

Bariatric Surgery for the Treatment of Morbid Obesity

Effective September 24, 2013, Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries when the following conditions are met: 1) the beneficiary has a body-mass index (BMI) = 35 kg/m2, 2) the beneficiary has at least one co-morbidity related to obesity, and 3) the beneficiary has been previously unsuccessful with medical treatment for obesity. Facility certification is no longer required for coverage of covered bariatric surgery procedures.

Cardiac Pacemakers

Under CMS revision

Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers

Effective August 13, 2013, CMS will cover implanted permanent cardiac pacemakers, single chamber or dual chamber, for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block.

Positron Emission Tomography (FDG) for Oncologic Conditions

Effective June 11, 2013, CMS continues to nationally cover one FDG PET study for beneficiaries who have cancers that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial anti-tumor treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

Three FDG PET scans are nationally covered when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy.

Aprepitant for Chemotherapy-Induced Emesis

Effective May 29, 2013, for claims with dates of service May 29, 2013 and later, CMS covers the oral antiemetic three-drug regimen of oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone for beneficiaries who are receiving one or more of the following anti-cancer chemotherapeutic agents: Alemtuzumab, Azacitidine, Bendamustine, Carboplatin, Carmustine, Cisplatin, Clofarabine, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin, Doxorubicin, Epirubicin, Idarubicin, Ifosfamide, Irinotecan, Lomustine, Mechlorethamine, Oxaliplatin, Streptozocin.

Ocular Photodynamic Therapy (OPT) & Photosensitive Drugs & Verteporfin

Effective April 3, 2013, CMS expanded coverage of ocular photodynamic therapy (OPT) with verteporfin for "wet" age-related macular degeneration (AMD) in NCD 80.3.1, Verteporfin. CMS revised the requirements for testing to permit either optical coherence tomography (OCT) or fluorescein angiography (FA) to assess treatment response.

OPT is only covered when used in conjunction with verteporfin (see section 80.3, "Photosensitive Drugs").

OPT is covered with a diagnosis of neovascular age-related macular degeneration (AMD) with predominately classic subfoveal choroidal neovascular (CNV) lesions (where the area of classic CNV occupies > 50% of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram(FA).

OPT with verteporfin for other ocular indications such as pathologic myopia or presumed ocular histoplasmosis syndrome, is eligible for coverage through individual Medicare Administrative Contractor discretion.

Positron Emission Tomography (PET) Scans

Effective March 7, 2013, local Medicare Administrative Contractors (MACs) may determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their Food and Drug Administration (FDA) approved labeled indications for oncologic imaging.

Percutaneous Transluminal Angioplasty

Effective January 1, 2013, percutaneous transluminal angioplasty (PTA) is covered when used under the following conditions:

• Treatment of Atherosclerotic Obstructive Lesions
• Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA)-Approved Category B Investigational Device Exemption (IDE) Clinical Trials
• Concurrent with Carotid Stent Placement in FDA-Approved Post Approval Studies
• Concurrent with Carotid Stent Placement in Patients at High Risk for Carotid Endarterectomy (CEA)
• Concurrent with Intracranial Stent Placement in FDA-Approved Category B IDE Clinical Trials

Blood-Derived Products for Chronic Non-Healing Wounds

Effective August 2, 2012, The Centers for Medicare and Medicaid Services (CMS) has determined that platelet-rich plasma (PRP) – an autologous blood-derived product, will be covered only for the treatment of chronic non-healing diabetic, venous and/or pressure wounds, and only under a clinical research study when specified criteria are met.

Liver Transplantation for Patients with Malignancies (Reconsideration)

Effective June 21, 2012, Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of adult liver transplantation for the following malignancies: (1) extrahepatic unresectable cholangiocarcinoma (CCA), (2) liver metastases due to a neuroendocrine tumor (NET), and (3) hemangioendothelioma (HAE).

Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)

Effective June 8, 2012, CMS covers TENS for CLBP when the beneficiary is enrolled in an approved clinical study meeting the requirements detailed in the NCD.

Transcatheter Aortic Valve Replacement (TAVR)

Effective May 1, 2012, CMS covers TAVR for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration (FDA) approved indication and when all of the conditions specified in the NCD are met. TAVR is also covered for uses that are not expressly listed as an FDA approved indication when performed within a clinical study meeting established requirements.

Extracorporeal Photopheresis (ECP)

Effective April 30, 2012, CMS covers ECP for the treatment of bronchiolitis obliterans syndrome (BOS) following lung allograft transplantation. Coverage is only allowed when ECP is provided under a clinical research study that meets specific requirements to assess the effect of ECP for the treatment of BOS following lung allograft transplantation.

Intensive Behavioral Therapy for Obesity

Effective November 29, 2011, CMS covers screening and counseling for obesity in a primary care setting. Medicare beneficiaries who screen for a body mass index meeting a specific threshold are eligible for one face-to-face counseling visit per week for one month, followed by one face-to-face counseling visit every other week for an additional five months. If beneficiaries receiving counseling reduce their weight by at least 6.6 pounds during the first six months of counseling, they are eligible for one face-to-face counseling visit every month for an additional six months.

Intensive Behavioral Therapy for Cardiovascular Disease

Effective November 8, 2011, CMS covers intensive behavioral therapy for cardiovascular disease (referred to below as a CVD risk reduction visit), if the service is provided by primary care practitioners in primary care settings such as the beneficiary’s family practice physician, internal medicine physician, or nurse practitioner in the doctor’s office. It consists of the following three components:

encouraging aspirin use for the primary prevention of cardiovascular disease when the benefits outweigh the risks for men age 45-79 years and women 55-79 years;

screening for high blood pressure in adults age 18 years and older; and,

intensive behavioral counseling to promote a healthy diet for adults with hyperlipidemia, hypertension, advancing age, and other known risk factors for cardiovascular and diet-related chronic disease.

Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs

Effective November 8, 2011, CMS covers screening for chlamydia, gonorrhea, syphilis and hepatitis B, as well as high intensity behavioral counseling (HIBC) to prevent STIs. These screenings are reasonable and necessary for the prevention or early detection of an illness or disability. The covered screening lab tests must be ordered by the primary care provider and the HIBC must be provided by primary care providers in primary care settings such as by the beneficiary’s family practice physician, internal medicine physician, or nurse practitioner in the doctor’s office.

Screening for Depression in Adults

Effective October 14, 2011, Medicare covers annual screening for adults for depression in the primary care setting that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up.

Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse

Effective October 14, 2011, CMS covers annual alcohol screening, and for those that screen positive, up to four, brief, face-to-face behavioral counseling interventions per year for Medicare beneficiaries, including pregnant women:

• who misuse alcohol, but whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence (defined as at least three of the following: tolerance, withdrawal symptoms, impaired control, preoccupation with acquisition and/or use, persistent desire or unsuccessful efforts to quit, sustains social, occupational, or recreational disability, use continues despite adverse consequences); and,
• who are competent and alert at the time that counseling is provided; and,
• whose counseling is furnished by qualified primary care physicians or other primary care practitioners in a primary care setting.