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CMS Manual System Department of Health &  Human Services (DHHS) Pub 100-03 Medicare National Coverage Determinations Centers for Medicare &  Medicaid Services (CMS) Transmittal 48 Date: MARCH 17, 2006   Change Request 4278  SUBJECT: Technical Corrections to the NCD Manual     I. SUMMARY OF CHANGES: We are making technical changes to correct for errors that occurred in converting the Coverage  Issues Manual to th e National Coverage Determination (NCD) Manual.  We are also making changes to remove coding from the NCDs as the statute exempts coding from  NCDs.  Specifically, we are deleting the duplicative material in section 20.8.3, 150.4,  160.3, and 160.11.  We have deleted the coding information from sections 40.2, 80.11, 140.1, 150.5, 210.1, 210.2, 260.1 and 300.1.  We are removing utilization paramete rs that were not part of the CIM policy immediately prior to conversion to the NC D manual from section 20.29.  We are removing a cross reference to a section de leted above from section 160.7.1. We are deleting inappropriate material form s ection 160.8.  We are deleting duplicate information from section 190.2 and inserting a cross reference to the remaining location.  We are restoring a portion of a sentence in limitation 7 in section 190.14 that was omitted in the manualization of the final rule a nnouncing the policy that was developed under negotiated rulemaking.  We are correcting typographical errors that occurred it the conversion of sections 230.8 and 230.19 from  the CIM to the NCD Manual.  We are deleting the material in section 270.1.1 that  inadvertently was not removed when the updated policy on electrical stimulation for wound healing was promulgated in section 270.1.   NEW/REVISED MATERIAL  EFFECTIVE DATE:  June 19, 2006 IMPLEMENTATION DATE: June 19, 2006   Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any ot her material was previously published and remains unchanged. However, if this revision  contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.    II. CHANGES IN MANUAL INSTRUCTIONS:   R = REVISED, N = NEW, D = DELETED    R/N/D CHAPTER / SECTION / SUBSECTION / TITLE  D 1/20.8.3/Anesthesia in Cardiac Pacemaker Monitors R 1/20.29/Hyperbaric Oxygen Therapy R 1/40.2/Home Glucose Monitors R 1/80.11/Vitrectomy R 1/140.1/Abortion D 1/150.4/Neuromuscular Electrical Stimulator (NMES) in the Treatment of Disuse Atrophy R 1/150.5/Diathermy Treatment D 1/160.3/Assessing Patients Suitability for Electrical Nerve Stimulation R 1/160.7.1/Assessing Patients Suit ability for Electrical Nerve Stimulation Therapy R 1/160.8/Electroencephalographic Monitoring During Surgical Procedures Involving the Cerebral Vasculature D 1/160.11/Osteogenic Stimulation R 1/190.2/Diagnostic Pap Smears R 1/190.14/Human Immunodeficiency Virus (HIV) Testing (Diagnosis) R 1/Table of Contents  R 1/210.1/Prostate Cancer Screening Tests R 1/210.2/Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer R 1/230.8/Non-Implantable Pelvic Floor Electrical Stimulator R 1/230.19/Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients N 1/260.1/Adult Liver Transplantation D 1/270.1.1/Electrostimulation in  the Treatment of Wounds R 1/300.1/Obsolete or Unreliable Diagnotic Tests    III. FUNDING:  No additional funding will be provided by CMS; contractor activities are to be carried out within their FY 2006 operating budgets.    IV. ATTACHMENTS:    Business Requirements Manual Instruction   *Unless otherwise specified, the e ffective date is the date of service.   Attachment - Business Requirements  Pub. 100-03 Transmittal: 48 Date: March 17, 2006 Change Request 4278  SUBJECT:  Technical Corrections to the NCD Manual  I. GENERAL INFORMATION    A. Background:   The CMS converted the Coverage Issues Ma nual (CIM) to the National Coverage Determinations (NCD) Manual in October 2003.  Th e conversion was intended to occur without any changes to the language.     B. Policy:  This manual transmittal corrects several errors th at occurred in the conversion of the CIM to the NCD Manual.  It also removes coding information from several sections in accordance with section 731 of the Medicare Modernization Act of 2003.  This  statutory provision excludes coding from NCDs.  There are no system changes associated with this change request.  II. BUSINESS REQUIREMENTS   Shall" denotes a mandatory requirement "Should" denotes an optional requirement  Requirement Number Requirements  Responsibility (X indicates the columns that apply) Shared System Maintainers   FI RHHI Car r ier DMERC F I SS MCS VMS CWF Other 4278.1 This CR correct typos and removes codes form the NCD Manual.  There are no substantive changes associated with this CR and no system changes associated with this CR.  Contractors should review any local publications to ensure they are consistent with national policy. XXXX     III. PROVIDER EDUCATION Requirement Number Requirements  Responsibility (X indicates the columns that apply)   FI RHHCarDMEShared System Maintainers Other F I SS MCS VMS CWF 4278.2 None.               IV. SUPPORTING INFORMATION AND PO SSIBLE DESIGN CONSIDERATIONS  A. Other Instructions:  NA   X-Ref Requirement # Instructions     B. Design Considerations:  NA  X-Ref Requirement #  Recommendation for Medicare System Requirements     C. Interfaces:  NA  D. Contractor Financial Reporting /Workload Impact:  NA   E. Dependencies:  NA  F. Testing Considerations:   NA  V. SCHEDULE, CONTACTS, AND FUNDING  Effective Date* :  June 19, 2006  Implementation Date:   June 19, 2006  Pre-Implementation Contact(s):   Jackie Sheridan-Moore  Post-Implementation Contact(s):   ROs No additional funding will be provided by CMS; contractor activities are to be carried out within their FY 2006 operating budgets.   *Unless otherwise specified, the effective date is the date of service.  20.29  Hyperbaric Oxygen Therapy (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-10 For purposes of coverage under Medicare, hyperbaric oxygen (HBO) therapy is a modality in which the entire body is exposed to oxygen under increased atmospheric pressure. A.  Covered Conditions Program reimbursement for HBO therapy will be  limited to that which is administered in a chamber (including the one man unit) a nd is limited to the following conditions:  l . Acute carbon monoxide intoxication,  2 . Decompression illness,  3 . Gas embolism,  4 . Gas gangrene,  5 . Acute traumatic peripheral ischemia.  HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened.  6.  Crush injuries and suturing of severe d limbs.  As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened.  7 . Progressive necrotizing infec tions (necrotizing fasciitis),  8. Acute peripheral arterial insufficiency,  9. Preparation and preservation of comp romised skin grafts (not for primary management of wounds),  10. Chronic refractory osteomyelitis, unr esponsive to conventional medical and surgical management,  11. Osteoradionecrosis as an adjunct to conventiona l treatment,  12. Soft tissue radionecrosis as an adjunct to conventional treatment,  13. Cyanide poisoning,  14. Actinomycosis, only as an adjunct to  conventional therapy when the disease process is refractory to antibiotics and surgical treatment,  15. Diabetic wounds of the lower extremities in patients who meet the following three criteria:  a. Patient has type I or type II di abetes and has a lower extremity wound that is due to diabetes; b. Patient has a wound classified as Wagner grade III or higher; and c. Patient has failed an adequate course of standard wound therapy.  The use of HBO therapy is covered as ad junctive therapy only after there are no measurable signs of healing for at least 30 da ys of treatment with standard wound therapy and must be used in addition to standard  wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patients vascular stat us and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granula tion tissue with appropriate moist dressings, appropriate off-loading, and necessary treatm ent to resolve any infection that might be present. Failure to respond to standard wound care occurs when th ere are no measurable signs of healing for at least 30 consecutive da ys. Wounds must be evaluated at least every 30 days during administration of HBO therapy.  Continued treatment with HBO therapy is not covered if measurable signs of healing ha ve not been demonstrated within any 30-day period of treatment. B.  Noncovered Conditions All other indications not specified under 270.4(A)  are not covered under the Medicare program.  No program payment may be made fo r any conditions other than those listed in 270.4(A).  No program payment may be made for HBO in  the treatment of the following conditions:  1. Cutaneous, decubitus, and stasis ulcers  2. Chronic peripheral vascular insufficiency  3. Anaerobic septicemia and infection other than clostridial  4. Skin burns (thermal).  5. Senility.  6. Myocardial infarction.  7. Cardiogenic shock. 8. Sickle cell anemia.  9.Acute thermal and chemical pulmonary damage, i.e., smoke inhalation with pulmonary  10. Acute or chronic cerebral vascular insufficiency.  11. Hepatic necrosis.  12. Aerobic septicemia.  13. Nonvascular causes of chronic brain syndrome (Picks di sease, Alzheimers disease, Korsakoffs disease)  14. Tetanus.  15. Systemic aerobic infection. 16. Organ transplantation.  17. Organ storage.  18. Pulmonary emphysema.  19. Exceptional blood loss anemia.  20. Multiple Sclerosis.  21. Arthritic Diseases.  22. Acute cerebral edema.  C.  Topical Application of Oxygen This method of administering oxygen does not meet the definition of HBO therapy as stated above.  Also, its clinical efficacy has not been established.  Therefore, no Medicare reimbursement may be made for th e topical application of oxygen. Cross reference:  270.5  of this manual.  40.2 - Home Blood Glucose Monitors (Rev. 48, Issued:  03-17-06; Effectiv e/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 covera ge of these devices varies, with respect to both the type of device and the medical c ondition of the patient for whom the device is prescribed.   Reflectance colorimeter devices used for m easuring 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-calibra tion 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 cond itions and limitations described below.