(Medicare National Coverage Determinations Manual)

 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.    Treatment must be discontinued if the patient is not improving or is regressing.  Physicians (as defined in 1861(r)(1) of the Social Security Act (the Act) may furnish acupuncture in accordance with applicable state requirements.  Physician assistants (PAs), nurse practitioners (NPs)/clinical nurse specialists (CNSs) (as identified in 1861(aa)(5) of the Act), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:   a masters or doctoral level de gree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine  (ACAOM); and,    a 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, PA, or NP/CNS required by our regulations at 42 CFR  410.26 and 410.27.   C. Nationally Non -Covered  Indications All types of acupuncture including dry needling for any condition other than cLBP are non-covered by Medicare.   D. Other  N/A (This NCD last reviewed January 2020.)   30.4 - Electrosleep Therapy  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that no national coverage determination (NCD) is appropriate at this time for Electrosleep Th erapy. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.   30.5 - Transcendental Meditation  (Rev. 1, 10- 03-03) CIM 35 -92  Not Covered   Transcendental med itation (TM) is a skill that is claimed to produce a state of rest and relaxation when practiced effectively.  Typically, patients are taught TM techniques over the course of several sessions by persons trained in TM.  The patient then uses the TM technique on his or her own to induce the relaxed state.  Proponents of TM have urged that Medicare cover the training of patients to practice TM when it is medically prescribed as treatment for mild hypertension, as adjunctive therapy in the treatment of essential hypertension, or as the sole or adjunctive treatment of anxiety and other psychological stress -related disorders.   After review of this issue, CMS has concluded that the evidence concerning the medical efficacy of TM is incomplete at best and does not de monstrate effectiveness and that a professional level of skill is not required for the training of patients to engage in TM.  Although many articles have been written about application of TM for patients with certain forms of hypertension and anxiety, ther e are no rigorous scientific studies that demonstrate the effectiveness of TM for use as an adjunct medical therapy for such conditions.  Accordingly, neither TM nor the training of patients for its use are covered under the Medicare program.  30.6 - Intra venous Histamine Therapy  (Rev. 1, 10- 03-03) CIM 35 -19  The only accepted and scientifically valid medical use of histamine is diagnostic, including tests to assess:    The ability of the stomach to secrete acid;   The integrity of peripheral sensory nerves (e.g., in leprosy);   The circulatory competency in limb extremities; and   The presence of a pheochromocytoma.   However, there is no scientifically valid clinical evidence that histamine therapy is effective for any condition regardless of the method of administration, nor is it accepted or widely used by the medical profession.  Therefore, histamine therapy cannot be considered reasonable and necessary, and program payment for such therapy is not made.  30.7 - Laetrile and Related Substances  (Rev. 1, 10- 03-03) CIM 45 -10  Not Covered   Laetrile (and the other drugs called by the various terms mentioned below) have been used primarily in the treatment or control of cancer.  Although the terms Laetrile, laetrile, amygdalin, Sarcarcinase, vitamin B -17, and nitriloside have been used interchangeably, the chemical identity of the substances to which these terms refer has varied.   The FDA has determined that neither Laetrile nor any other drug called by the various terms mentioned above, nor any other product which might be characterized as a nitriloside is generally recognized (by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs) to be safe and effective for any therapeutic use.  T herefore, use of this drug cannot be considered to be reasonable and necessary within the meaning of 1862(a)(1)  of the Act and program payment may not be made for its use  or any services furnished in connection with its administration.  A hospital stay only for the purpose of having laetrile (or any other drug called by the terms mentioned above) administered is not covered.  Also, program payment may not be made for laetr ile (or other drug noted above) when it is used during the course of an otherwise covered hospital stay.  30.8 - Cellular Therapy (Rev. 1, 10- 03-03) CIM 35 -5  Not Covered   Cellular therapy involves the practice of injecting humans with foreign proteins like the placenta or lungs of unborn lambs.  Cellular therapy is without scientific or statistical evidence to document its therapeutic efficacy and, in fact, is considered a potentially dangerous practice.  Accordingly, cellular therapy is not considered rea sonable and necessary within the meaning of 1862 (a) (1)  of the Act.   30.9 - Transillumination Light Scanning, or Diaphanography  (Rev. 1, 10- 03-03) CIM 50 -46  Not Covered   While transillumination light scanning, or diaphanography, for use in detection of cancer and other diseases of the breast, appears safe, the usefulness of this instrumentation, when compared to existing modes of cancer and other breast disease detection, has not clearly been established.  Further study of this technology is needed to determine its role in breast cancer diagnosis.  Program payment may not be made for this procedure at this time.   40 - Endocrine System and Metabolism  (Rev. 1, 10- 03-03)  40.1 - Diabetes Outpatient Self-Management Training (Rev. 1, 10- 03-03) CIM 80 -2  Refer to 42 CFR 410.140 -  410.146 for conditions that must be met for Medicare coverage.   40.2 - Home Blood Glucose Monitors  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM 60 -11  There are several different types of blood glucose monitors that use reflectance meters to determine blood glucose levels.  Medicare coverage of these devices varies, with respect to both the type of device and the medical condition of the patient for whom the device is prescribed.   Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for use in the home because their need for frequent professional re -calibration makes them unsuitable for home use. However, some types of blood glucose monitors which use a reflectance meter specifically designed for home use by diabetic patients may be covered as durable medical equipment, subject to the conditions and limitations described below.  Blood glucose monitors are meter devices that read color chang es produced on specially treated reagent strips by glucose concentrations in the patients blood.  The patient, using a disposable sterile lancet, draws a drop of blood, places it on a reagent strip and, following instructions which may vary with the devic e used, inserts it into the device to obtain a reading.  Lancets, reagent strips, and other supplies necessary for the proper functioning of the device are also covered for patients for whom the device is indicated.  Home blood glucose monitors enable cert ain patients to better control their blood glucose levels by frequently checking and appropriately contacting their attending physician for advice and treatment.  Studies indicate that the patients ability to carefully follow proper procedures is critical  to obtaining satisfactory results with these devices. In addition, the cost of the devices, with their supplies, limits economical use to patients who must make frequent checks of their blood glucose levels.  Accordingly, coverage of home blood glucose monitors is limited to patients meeting the following conditions:  1. The patient has been diagnosed as having diabetes;   2. The patients physician states that the patient is capable of being trained to use the particular device prescribed in an appropriate manner.  In some cases, the patient may not be able to perform this function, but a responsible individual can be trained to use the equipment and monitor the patient to assure that the intended effect is achieved. This is permissible if the record is properly documented by the patients physician; and  3. The device is designed for home rather than clinical use.  There is also a blood glucose monitoring system designed especially for use by those with visual impairments.  The monitors used in such systems are identical in terms of reliability and sensitivity to the standard blood glucose monitors described above.  They differ by  having such features as voice synthesizers, automatic timers, and specially designed arrangements of supplies and materials to enable the visually impaired to use the equipment without assistance.   These special blood glucose monitoring systems are covere d under Medicare if the following conditions are met:    The patient and device meet the three conditions listed above for coverage of standard home blood glucose monitors; and    The patients physician certifies that he or she has a visual impairment severe  enough to require use of this special monitoring system.  The additional features and equipment of these special systems justify a higher reimbursement amount than allowed for standard blood glucose monitors.  Separately identify claims for such devices and establish a separate reimbursement amount for them.   40.3 - Closed -Loop Blood Glucose Control Device (CBGCD)  (Rev. 1, 10- 03-03) CIM 35 -70  The closed -loop blood glucose control device (CBGCD) is a hospital bedside device designed for short -term management of patients with insulin dependent diabetes mellitus (Type I).  It consists of a rapid on- line glucose analyzer; a computer with a controller for the calculation and control of the infusion of either insulin or dextrose; a multi -channel infusion system;  and a printer designed to record continuous glucose values and to provide cumulative totals of the substances infused.  Its primary use is for the stabilization of Type I diabetics during periods of stress, such as trauma, labor and delivery, and surgery, when there are wide fluctuations in blood sugar levels.  It serves to temporarily correct abnormal blood glucose levels (hyper - or hypo- glycemia) and this correction is made by infusion of either insulin or dextrose.  Its use is generally limited to a 24- to 48- hour period because of potential complications; (e.g., sepsis, thromboses, and nonportability, etc.).  The CBGCD requires specialized training for use and interpretation of its diagnostic and therapeutic contribution and continuous observation by specially trained medical personnel.   Use of the CBGCD is covered for short -term management of insulin dependent diabetics in crisis situations, in a hospital inpatient setting, and only under the direction of specially trained medical personnel.   40.4 - Insulin Syringe  (Rev. 1, 10- 03-03) CIM 45 -3  Medical supplies are covered under 1861(s)(2)(A)  of the Act only when they are furnished incident to a physicians profes sional services.  To be covered under this provision an insulin syringe must have been used by the physician or under his/her direct personal supervision, and the insulin injection must have been given in an emergency situation (e.g., diabetic coma).  The use of an insulin syringe by a diabetic would not meet the requirements of 1861(s)(2)(A) of the Act.  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 30.   40.5  Treatment of Obesity  (Rev. 158, Issued: 12- 23-13, Effective: 09 -24-13, Implementation: 12 -17-13)