(Medicare National Coverage Determinations Manual)

l. 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 t hese populations, and a plan for the retention and reporting of said populations in 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.   m. 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 el igible for Medicare due to age, disability, or Medicaid eligibility.   C.  Nationally Non -Covered Indications   LAAC is non -covered for the treatment of NVAF when not furnished under CED according to the above -noted criteria.   (This NCD last reviewed February 2016.)   20.35 - Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)  (Rev. 207, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18)  A.  General   Research has shown supervised exercise therapy (SET) to be an effective, minimally invasive method to alleviate the most common symptom associated with peripheral artery disease (PAD)  intermittent claudication (IC).   SET has been shown to be significantl y more effective than unsupervised exercise, and could prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients.   SET has also been shown to perform at least as well as more invasive revascularization treatments that are covered by Medicare.     B.  Nationally Covered Indications   Effective for services performed on or after May 25, 2017, the Centers for Medicare & Medicaid Services has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic 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 physicians office;   be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and   be unde r the direct supervision of a physician (as defined in 1861(r)(1)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) who must be trained in both basic and advanced life support techniques.   Beneficiaries must have a face- to-face visit with the physician responsible for PAD treatment to obtain the referral for SET.   At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.    C.  Nationally Non -Covered Indications   SET is non -covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician.   D.  Other  Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond the nationally covered 36 sessions over a 12- week period. MACs may cover an additional 36 sessions over an extended period of time.  A second referral is required fo r these additional sessions   (This NCD last reviewed May 2017.)   30 - Complementary and Alternative Medicine  (Rev. 1, 10- 03-03)  30.1 - Biofeedback Therapy  (Rev. 1, 10- 03-03) CIM 35 -27  Biofeedback therapy provides visual, auditory or other evidence of the status of certain body functions so that a person can exert voluntary control over the functions, and thereby alleviate an abnormal bodily condition.  Biofeedback therapy often uses ele ctrical devices to transform bodily signals indicative of such functions as heart rate, blood pressure, skin temperature, salivation, peripheral vasomotor activity, and gross muscle tone into a tone or light, the loudness or brightness of which shows the e xtent of activity in the function being measured.   Biofeedback therapy differs from electromyography which is a diagnostic procedure used to record and study the electrical properties of skeletal muscle.  An electromyography device may be used to provide f eedback with certain types of biofeedback.  Biofeedback therapy is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re -education of specific muscle groups or for treating pathological muscle abnormalitie s of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments (heat, cold, massage, exercise, support) have not been successful.  This therapy is not covered for treatment of ordinary muscle tension states or for psychosomatic  conditions.  (See the Medicare Benefit Policy Manual, Chapter 15, for general coverage requirements about physical therapy requirements.)   30.1.1 - Biofeedback Therapy for the Treatment of Urinary Incontinence  (Rev. 1, 10- 03-03) CIM 35 -27.1  Biofeedback Therapy for the Treatment of Urinary Incontinence   This policy applies to biofeedback therapy rendered by a practitioner in an office or other facility setting.   Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training.  Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform PME.  Biofeedback -assisted PME incorporates the use of an electr onic or mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in order to improve awareness of pelvic floor musculature and to assist patients in the performance of PME.   A failed trial of PME training is defined as no cli nically significant improvement in urinary incontinence after completing four weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength.   Contractors may decide whether or not to cover biofeedback as an initial treatment modality.   Home use of biofeedback therapy is not covered.   30.2 - Thermogenic Therapy  (Rev. 1, 10- 03-03) CIM 35 -6  Not Covered   Thermogenic therapy which is the production of artificial fever, has been in use since 1919 in the treatment of certain types of resistant infectious diseases, rheumatoid arthritis and Sydenhams chorea.  Regardless of the medium by which the fever is induced, this modality is not scientifically accepted for the treatment of any specific disease.  Since the advent of potent antibi otics, the procedure has for all practical purposes been replaced as a mode of treatment.  Therefore, thermogenic therapy is not considered reasonable and necessary for the treatment of an illness or injury as required by 1862(a)(1)  of the Act.  (Of course, where other covered services are needed and it would be reasonable and necessary that they be furnished on an inpatient hospital basis, payment would not be excluded for the inpatient stay, notwithstanding the fact that reimbursem ent may not be made for thermogenic therapy furnished during the hospital stay.)   30.3 - Acupuncture  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  Effective for claims with dates of service on and after January 21, 2020, acupuncture is only covered for chronic low back pain under section 1862(a)(1)(A) of the Social Security Act (the Act). See National Coverage Determination section 30.3.3 for specific coverage criteria.  C. Nationally Non -Covered  Indications   Medicare reimbursement for acupuncture, as an anesthetic, or as an analgesic or for other therapeutic purposes, may not be made unless the specific indication is excepted.  All indications for acupuncture outside of NCD section 30.3.3 remain non- covered.  D. Other N/A (This NCD last rev iewed January 2020.)     30.3.1  Acupuncture for Fibromyalgia (Effective April 16, 2004)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  N/A for acupuncture for fibromyalgia.  C. Nationally Non -Covered  Indications   Effective for claims  with dates of service on and after April 16, 2004, after careful reconsideration of its initial non -coverage determination for acupuncture, the Centers for Medicare & Medicaid Services (CMS) concludes that there is no convincing evidence for the use of acupuncture for pain relief in patients with fibromyalgia. Study design flaws presently prohibit assessing acupunctures utility for improving health outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable and necessary for the tr eatment of fibromyalgia within the meaning of 1862(a)(1) of the Social Security Act, and the national non- coverage determination for acupuncture for fibromyalgia continues. D. Other N/A (This NCD last reviewed April 2004.)   30.3.2  Acupuncture for Osteoarthritis (Effective April 16, 2004)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  N/A for acupuncture for osteoarthritis. C. Nationally Non -Covered  Indications   Effective for claims with dates of service on and after April 16, 2004, after careful reconsideration of its initial non -coverage determination for acupuncture, the Centers for Medicare & Medicaid Services (CMS) concludes that there is no convincing evidence for the use of acupuncture for pain relief in pa tients with osteoarthritis. Study design flaws presently prohibit assessing acupunctures utility for improving health outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable and necessary for the treatment of osteoarthritis within the meaning of 1862(a)(1) of the Social Security Act, and the national non- coverage determination for acupuncture for osteoarthritis continues. D. Other N/A (This NCD last reviewed April 2004.)   30.3.3  Acupuncture for Chronic Lower Back Pain (cLBP)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)  A.  General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and no n-needling techniques. B. Nationally Covered  Indications Effective for services performed on or after January, 21, 2020, CMS will cover acupuncture for Medicare patients with chronic Lower Back Pain (cLBP.) Up to 12 visits in 90 days are covered for Medicare beneficiaries under the following circumstance:    For the purpose of this decision, cLBP is defined as:  o Lasting 12 weeks or longer;  o nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc.  disease);  o not associated with surgery;  and, o not associated with  pregnancy.    An additional 8 sessions will be covered for those patients demonstrating an improvement.    No more than 20 acupuncture treatments may be administered annually.