This is effective for services on or after May 25, 2017.
The Centers for Medicare and Medicaid Services (CMS) issued an NCD to cover SET for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic PAD.
SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest.
SET has been recommended as the initial treatment for patients suffering from IC, the most common symptom experienced by people with PAD.
Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met. The SET program must:
- Consist of sessions lasting 30-60 minutes, comprising a therapeutic exercise-training program for PAD in patients with claudication
- Be conducted in a hospital outpatient setting, or a physician’s office
- Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD
- Be under the direct supervision of a physician (as defined in Section 1861(r)(1)) of the Social Security Act (the Act), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in Section 1861(aa)(5) of the Act)) who must be trained in both basic and advanced life support techniques.
This summarizes CMS transmittal 207 (replacing 204, 205 and 206).
Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen)
This is effective for services on or after April 3, 2017.
Local Medicare administrators will decide if they’ll cover topical oxygen for the treatment of chronic non-healing wounds.
This summarizes CMS transmittal 203.
Leadless pacemaker
This affects services given on or after 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.
Percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS)
This affects services given on or after December 7, 2016.
This back surgery will be covered if you are part of an approved clinical trial.
Other types of surgery for your condition are not covered. This includes endoscopically assisted laminotomy/laminectomy and other open lumbar decompression procedures.
This is now expanded to cover a prospective longitudinal study of PILD procedures using an FDA-approved/cleared device if the study completed a CMS-approved randomized clinical trial that met established criteria.
This summarizes CMS transmittal 200 (replacing 167 and 199).
Screening for Hepatitis B Virus (HBV) Infection
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. Effective September 28, 2016, 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.
Percutaneous Left Atrial Appendage Closure (LAAC)
This affects services given on or after February 8, 2016.
Percutaneous LAAC will be covered only through Coverage with Evidence Development (CED) when the patient both:
- Has Nonvalvular Atril Fibrillation (NVAF)
- Follows FDA guidelines for treating percutaneous LAAC while using an FDA-approved device
If you think you qualify, speak with your physician.
To receive coverage, you must have:
- A CHADS2 score of 2 or higher (Congestive heart failure, Hypertension, over 75 years old, Diabetes,Stroke/transient ischemia attack/thromboembolism) or a CHA2DS2-VASc score of 3 or higher (Congestive heart failure, Hypertension, 65 years or older, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category)
- Formally met with and made the decision for treatment with an independent, non-interventional physician
- Received a recommendation from your physician for short-term warfarin, but you can’t take long-term oral anticoagulation (blood thinners)
This summarizes CMS transmittal 192.
Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes
This affects services given on or after January 27, 2016.
Expanded coverage of allogenic (donor) hematopoietic stem cell transplantation (HSCT) for:
- Sickle cell disease
- Myelofibrosis
- Multiple myeloma
- Rare diseases
In the HSCT procedure, a doctor takes part of a healthy donor's stem cell or bone marrow and prepares it for intravenous infusion (usually an injection using an IV.) It also includes using high dose chemotherapy and/or radiotherapy before the actual transplant.
This NCD expands coverage for donor HSCT items and services. They’ll only be covered by Medicare if it’s provided in a Medicare-approved clinical study under Coverage with Evidence Development (CED.) When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage.
This summarizes CMS transmittal 193 (replacing 191).
Revised coverage features for speech generating devices (SGDs)
This affects services given on or after July 29, 2015.
Revised features for covered SGDs include speech generated using one of the following methods:
- Digitized audible/verbal speech output using prerecorded messages
- Synthesized audible/verbal speech outputthat requires message formulation
- Synthesized audible/verbal speech output for multiple methods of message formulation and device access
- Software that allows a computer or other electronic device to generate audible/verbal speech
Other covered features of the device include the:
- Capability to generate email, text or phone messages to allow the patient to "speak" or communicate remotely
- Capability to download updates to the covered features of the device from the manufacturer or supplier of the device
The cost of non-covered features is the responsibility of the beneficiary. However, in some cases, Medicare administratiors may allow payment for some non-covered SGDs and features. They decide this based on what they find is reasonable and necessary.
This summarizes CMS transmittal 184.
Screening for cervical cancer with human papillomavirus (HPV) testing
This affects services given on or after July 9, 2015.
HPV testing is now an additional preventive service benefit under the Medicare program. We will cover this testing:
- Once every five years
- If you’re 30 to 65 years old and have no symptoms
- When you have it done with the Pap smear test
To get coverage, you must receive your screening for cervical cancer:
- With the appropriate U.S. Food and Drug Administration (FDA)-approved laboratory test
- In a matter consistent with FDA-approved labeling
- In compliance with the Clinical Laboratory Improvement Act (CLIA) regulations
This summarizes CMS transmittal 189.
Screening for human immunodeficiency virus (HIV) infection
This affects services given on or after April 13, 2015.
You can be tested for early detection of HIV if you’re:
- Entitled to benefits under Medicare Part A or enrolled under Part B
- 15to 65 years old
We will only cover one HIV screening per year if:
- Your doctor or a practitioner in a healthcare setting requests it
- You meet the criteria for the test
- You use a U.S. Food and Drug Administration (FDA)-approved laboratory test or point-of-care test
- Your testing is consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations
- Your test is performed by an eligible Medicare provider
This summarizes CMS transmittal 190.
Screening for lung cancer with low-dose computed tomography (LDCT)
This affects services given on or after February 5, 2015.
Services affected:
- Lung cancer screening with LDCT once per year
- Visit for counseling and shared-decision making on the benefits and risks of lung cancer screening
To receive these services, as a Medicare beneficiary, you must:
- Be55 to 77 years old and either a current smoker or have quit smoking within the last 15 years
- Have a tobacco smoking history of at least 30 “pack years” (an average of one pack a day for 30 years)
- Get a written order from a physician or qualified non-physician practitioner like a physician assistant, nurse practitioner or clinical nurse specialist
Microvolt T-wave alternans (MTWA)
This affects services given on or after January 13, 2015.
CMS decided that it’s not appropriate to supply a National Coverage Determination for MTWA testing using the modified moving average (MMA) method. The MMA method is a type of heart scan that evaluates patients at risk for sudden cardiac death (SCD), also called cardiac arrest. Because of this decision, this kind of testing will be covered in some areas. Local contractors will decide whether this testing receives Medicare coverage in their service areas. As a Medicare Advantage Organization, Aetna will follow your local Medicare administrator’s policy on covering your heart scan.
This summarizes CMS transmittal R182.
Removal of multiple National Coverage Determinations using expedited process
This affects services given on or after December 18, 2014. Unless noted, the effective date is the date of service.
Sections affected:
- 50.6 - Tinnitus masking
- 160.4 - Stereotactic cingulotomy for psychosurgery
- 160.6 - Carotid sinus nerve stimulator
- 160.9 - Electroencephalographic (EEG) monitoring during open-heart surgery
- 190.4 - Electron microscrope
- 220. 7 - Xenon scan
- 220.8 - Nuclear radiology procedure
These sections will be removed from Pub. 100-03, Medicare National Coverage Determinations Manual.
This doesn’t mean the services aren't covered. We’ll still review services that are reasonable and necessary for your diagnosis or condition.
Screening for colorectal cancer using Cologuard™, a multitarget stool DNA test
This affects services given on or after October 9, 2014.
Medicare Part B covers CologuardTM – a multitarget stool DNA test – once every three years, for Medicare beneficiaries who meet all of the following standards:
- 50 to 85 years old
- No known symptoms: Includes, but is not limited to lower stomach pain, blood in the stool, a positive fecal blood test
- At average risk of getting colorectal cancer: Includes, but is not limited to no personal or family history of colorectal cancer, ulcerative colitis, certain bowel diseases
There is no coinsurance or deductible for the tests that are administered once every three years.
This summarizes CMS transmittal 183.
Requirements for medical need of a hospital bed
This affects services given on or after October 01, 2014.
CMS has advised a doctor’s prescription and additional documents must explain the medical need for a hospital bed. Acceptable reasons explaining the medical need include:
- Your condition requires your body to be positioned in ways it can’t in a normal bed. This positioning is done to:
-Lessen pain
-Promote good body alignment
-Prevent contractures
-Avoid respiratory infections, and more - Your condition requires special attachments that can't be used on an ordinary bed.
A variable-height hospital bed may also be medically necessary and covered for any of the following conditions:
- Severe arthritis and other injuries to your lower body, such as a fractured hip. This is so you can place your feet on the floor while sitting on the edge of the bed.
- Severe heart conditions. This is so you can leave the bed and avoid the strain of “jumping” up or down to do so.
- Spinal cord injuries, including quadriplegic and paraplegic patients, multiple limb amputee and stroke patients. This is to allow you to transfer from bed to a wheelchair with or without help.
- Other severe and limiting diseases or conditions that require a variable-height feature to help you get into or out of bed.
Transcatheter mitral valve repair
This affects services given on or after August 7, 2014.
Medicare will cover your heart valve surgery if all these apply:
- You were examined by your heart doctor and surgeon.
- They did so at different times.
- Your heart doctor and surgeon list the reasons you need the surgery.
- The government approves the device used in your surgery.
- A heart team manages your care.
- Your heart team and hospital are on the national list of clinical trials.
This summarizes CMS transmittal 178.
Screening for hepatitis C virus
This affects services given on or after June 2, 2014.
If your doctor says you’re at high risk, CMS will cover a blood test to see if you have the hepatitis C virus. To be at high risk, you either:
- Had a blood transfusion before 1992
- Use or have used injected drugs that are not legal
CMS must approve the person who does your blood test. CMS will cover the blood test each year if you:
- Tested negative the year before
- Used injected drugs that are not legal since the last blood test
This summarizes CMS transmittal 174.
Aprepitant for chemotherapy-induced emesis (nausea and vomiting)
This affects services given on or after May 29, 2013. Updated April 14, 2014.
Aprepitant is a drug used with two others. It prevents nausea and vomiting caused by chemotherapy (chemo).
We cover the oral form, the form you take by mouth, only in certain cases. For example, if your doctor orders it for you right before and within 48 hours after your chemo treatment, it is covered. If you have Medicare Part D, other uses of this oral drug may be covered.
April 4, 2005: CMS announced a NCD for the use of the oral three-drug regimen of aprepitant, a 5HT3 antagonist, and dexamethasone. The regimen is for patients who are receiving the below nine anticancer chemo agents.
- Carmustine
- Cisplatin
- Cyclophosphamide
- Dacarbazine
- Mechlorethamine
- Streptozocin
- Doxorubicin
- Epirubicin
- Lomustine
April 14, 2014: CMS released an additional update to the April 4, 2005 NCD. It is retroactive to May 29, 2013.
The update added more drugs to the existing list of approved anticancer chemo agents.
We now also cover the drugs below for the oral antiemetic three-drug regimen of an oral aprepitant, an oral 5HT3 antagonist and oral dexamethasone:
- Alemtuzumab
- Azacitidine
- Bendamustine
- Carboplatin
- Carmustine
- Cisplatin
- Clofarabine
- Cyclophosphamide
- Cytarabine
- Dacarbazine
- Daunorubicin
- Doxorubicin
- Epirubicin
- Idarubicin
- Ifosfamide
- Irinotecan
- Lomustine
- Mechlorethamine
- Oxaliplatin
- Streptozocin
This summarizes CMS transmittal 165. It replaces and rescinds CMS transmittal 163.
Intensive cardiac rehabilitation (ICR) program
This affects services given on or after May 6, 2014.
Services affected:
Intensive Cardiac Rehabilitation Program - Benson-Henry Institute Cardiac Wellness Program
If your doctor wants you to take part in this heart wellness program, Medicare will cover it.
This summarizes CMS transmittal 175.
Cardiac rehabilitation programs for chronic heart failure
This affects services given on or after February 18, 2014.
Medicare will cover your heart rehabilitation if you have chronic heart failure. This condition must be stable. This means you have taken drugs for your condition for at least six weeks and still have symptoms.
This summarizes CMS transmittal 171.
Ultrasound screening for abdominal aortic aneurysms (AAA) and screening fecal-occult blood tests (FOBT)
This affects services given on or after January 27, 2014.
Medicare covers one test a year to see if you have an enlarged blood vessel in your belly. This test is painless. You lie on your back and a technician uses a camera to take images. You need your doctor’s OK to have this test.
Medicare also covers one test a year to see if you have colorectal cancer. For this test, you put a tiny sample of your stool on a special card or cloth. A lab tests it. You need your doctor’s OK to have this test.
This summarizes CMS transmittal 176.
Ventricular assist devices for bridge-to-transplant and destination therapy
This affects services given on or after October 30, 2013.
Medicare will cover your heart pump if:
- You had a heart transplant
- You’re waiting for a heart transplant
- You’re not a candidate for a heart transplant, but you need the pump and also meet certain clinical conditions
Medicare must approve the hospital you’ll use for this procedure.
Are you waiting for a heart transplant? You must be on an active wait list. It’s maintained by the Organ Procurement and Transplantation Network.
This summarizes CMS transmittal R172.
Change in coverage of beta amyloid (Aβ) positron emission tomography (PET) in dementia and neurodegenerative disease
This affects services given on or after September 27, 2013.
Prior to 9/27/2013, Medicare didn't cover positron emission tomography (PET) beta amyloid imaging (also referred to as PET amyloid-beta (Aβ), based on a longstanding general non-coverage of PET.
Effective 9/27/2013 Medicare will cover one PET Aβ imaging scan if you’re enrolled in certain clinical trials or research studies.
Review more information about this NCD. Clinical study, clinical trial and research study criteria begin on page 7.
Change in coverage of bariatric surgery for treatment of co-morbid conditions related to morbid obesity
This affects services given on or after September 24, 2013.
CMS has removed the facility certification requirement, which required that these bariatric procedures were covered only when performed at facilities that are:
- Certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center
- Certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE)
Any certifications for other surgical procedures still apply.
Single-chamber and dual-chamber permanent cardiac pacemakers
This affects services given on or after August 13, 2013.
CMS has advised on the treatment of non-reversible symptomatic bradycardia (slow heart rate). CMS has guided that implanted permanent cardiac pacemakers, single- or dual-chamber, are reasonable and necessary for this condition.
Symptoms of bradycardia happen when your heart rate is less than 60 beats per minute. Symptoms include syncope (fainting), seizures, congestive heart failure, dizziness, or confusion.
Change in coverage of fluorodeoxyglucose (FDG) positron emission tomography (PET) for solid tumors
This affects services given on or after June 11, 2013.
CMS covers 3 PET scans after you finish your therapy for solid tumors. The scans must be used as a guide for treating your same cancer diagnosis. If you have more than 3 PET scans, your local Medicare administrator will decide if they can be covered.
Ocular photodynamic therapy (OPT) with verteporfin for macular degeneration
This affects services given on or after April 3, 2013.
CMS will cover treatment for neovascular age-related macular degeneration with injections of verteporfin. This treatment blocks the development of new blood vessels and leakage from abnormal vessels. In follow-up visits, your doctor will assess how the treatment is working. He/she will do this with either an optical coherence tomography (OCT) or fluorescein angiography.
Autologous platelet-rich plasma (PRP) for chronic non-healing diabetic, venous and/or pressure wounds
This services given on and after August 2, 2012.
CMS will cover PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds only when provided under a clinical research study that meets specific requirements. The requirements are that the study assess the health outcomes of PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds.
Bariatric surgery for treatment of morbid obesity
This affects services given on or after June 27, 2012.
Services provided:
Laparoscopic Sleeve Gastrostomy (LSG), including:
- Open and laparoscopic Roux-en-Y gastric bypass (RYGBP)
- Laparoscopic adjustable gastric banding (LAGB)
- Open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS)
Additional information:
Covers stand-alone laparoscopic sleeve gastrostomy (LSG) for treating other qualified medical conditions related to obesity. Available to Medicare beneficiaries who meet all of the following conditions:
- Body-mass index (BMI) greater than or equal to 35 kg/m
- At least one other qualified medical condition related to obesity
- Previous unsuccessful medical treatment for obesity
Procedure will only be covered when performed at facilities that are certified by either:
- The American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center
- The American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006)
Adult liver transplant for patients with malignancies
This affects services given on or after June 21, 2012.
Covered if you have any of the following:
- Extrahepatic unresectable cholangiocarcinoma (CCA)
- Liver metastases due to a neuroendocrine tumor (NET)
- Hemangioendothelimo (HAE)
The transplant must be performed at an approved liver transplant center. This change does not apply to any other malignancies.
Transcutaneous electrical nerve stimulation (TENS) for chronic low back pain (CLBP)
This affects services on or after June 8, 2012.
Covered if:
- You have pain for more than three months
- The pain is not due to a “clearly defined and generally recognizable primary disease”
- You are enrolled in an approved clinical study
Transcatheter aortic valve replacement (TAVR)
This affects services on or after May 1, 2012.
Covered if you’re entered into a qualified national registry and:
- The procedure is done for the treatment of symptomatic aortic stenosis
- The procedure is done for an FDA-approved condition for use with an approved device
- Your use is unapproved by the FDA, but you’re enrolled in a qualifying clinical study
Two heart surgeons must examine you before you receive the TAVR to see if it will work for you.
Extracorporeal photopheresis to treat bronchiolitis obliterans syndrome (BOS) after lung transplant
This affects services given on or after April 30, 2012.
The Centers for Medicare and Medicaid Services (CMS) have added coverage for extracorporeal photopheresis treatment. This is for people who get bronchiolitis obliterans syndrome (BOS) after a lung transplant. You’ll need to enroll in certain clinical research studies for this BOS treatment to be covered. The treatment may help your immune system fight illness better. This study will be used to see if the treatment can improve your health in the following areas:
- Volume of air exhaled in one second
- Survival after transplant
- Quality of life
Extracorporeal photopheresis can be used to treat bronchiolitis obliterans syndrome (BOS) after a lung transplant. It must be provided as part of a clinical research study. These studies must meet specific requirements and be approved on or before April 30, 2014. If no studies are approved by that date, coverage will remain as it was before April 30, 2012.
Coverage for new preventive services and health risk assessments
CMS has added coverage for new preventive services and health risk assessments to the annual wellness visit benefit. This coverage is now available for all Medicare Advantage members. These services:
- Help you find out if you may be at risk for certain health conditions
- Are covered at zero cost sharing and require no coinsurance, copayment or deductible if you use an Aetna participating, in-network primary care provider
- Must be done in a primary care setting
You may have to pay cost sharing if you use an out-of-network provider.
Intensive behavioral therapy for obesity
This affects services on or after November 29, 2011.
This therapy includes:
- One face-to-face visit every week for the first month
- One face-to-face visit every other week for months 2-6
- One face-to-face visit every month for months 7-12, if you meet thespecified weight loss requirements
Intensive behavioral therapy for cardiovascular disease
This affects services on or after November 8, 2011.
Includes one face-to-face risk reduction visit annually.
Intensive behavioral counseling to prevent sexually transmitted infections
This affects services on or after November 8, 2011.
Includes two face-to-face visits annually. Also covers the laboratory screening for chlamydia, gonorrhea, syphilis and hepatitis B.
Annual alcohol screening and counseling
This affects services on or after October 14, 2011.
If you screen positive, up to four brief face-to-face behavioral counselingmeetings are covered annually.
Adult annual depression screening
This affects services on or after October 14, 2011.
Covered if done in a primary care setting that has staff-assisted depression care supports in place.
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Y0001_4006_10829Approved 10/27/2017
Page last updated: Wed Jul 14 16:51:22 UTC 2021
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