evekhm/cms_iom_500 huggingface dataset:
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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
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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.
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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.
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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:
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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:
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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.
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Blood glucose monitors are meter devices that  read color changes produced on specially treated reagent strips by glucose concentrations in the pa tients 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 th e device 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 certain pa tients to better cont rol their blood glucose levels by frequently checking and appropriately contacting their attending physician for advice and treatment.  Studies indicate that th e patients ability to carefully follow proper procedures is critical to obt aining 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 leve ls.  Accordingly, coverage of home blood glucose monitors is limited to pati ents meeting the following conditions:  1. The patient has been diagnosed as having diabetes;  2. The patients physician states that the patient  is capable of bei ng 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 res ponsible 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 synt hesizers, 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 sy stems are covered under Medicare if the following conditions are met:   The patient and device meet the three c onditions 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.
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The additional features and equipment of  these special systems justify a higher reimbursement amount than allowed for sta ndard blood glucose monitors.  Separately identify claims for such devi ces and establish a separate re imbursement amount for them.   80.11 - Vitrectomy (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM - 35-16 Vitrectomy may be considered reasonable and necessary for the following conditions:  vitreous loss incident to cataract surgery, vi treous opacities due to vitreous hemorrhage or other causes, retinal detachments secondary to vitreous strands, proliferative retinopathy, and vitreous retraction.  See chapter 23 of the Medicare Claims Processing Manual for how to determine payment for physician vitr ectomy services and the Medicare Claims Processing Manual, Chapter 14, Ambulator y Surgical Centers, 40, for how to determine payment for ASC facility vitrectomy services.  Also, see the Medicare Claims Processing Manual, Chapter 23, Fee Schedule Administration and Coding Requirements, 20.9, to identify when, for Medicare payment purposes, certain vitrectomy codes are included in other codes or when codes for other services include vitrectomy codes.  140.1 - Abortion (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-99  Abortions are not covered Medicare procedures except:  1.  If the pregnancy is the result  of an act of rape or incest; or  2.  In the case where a woman suffers from  a physical disorder, physical injury, or physical illness, including a life-endangering physical condition caused by or arising from the pregnancy itself, that would, as  certified by a physician, place the woman in danger of death unless an abortion is performed.  150.5 - Diathermy Treatment  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-41
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150.5 - Diathermy Treatment  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-41  High energy pulsed wave diathermy machin es have been found to produce some degree of therapeutic benefit for essentially the sa me conditions and to the same extent as standard diathermy.  Accordingly, where th e contractors medical staff has determined that the pulsed wave diathermy apparatus used is one which is considered therapeutically effective, the treatments are considered a covered service, but onl y for those conditions for which standard diathermy is medical ly indicated and only when rendered by a physician or incident to a phys icians professional services .  Cross-reference: 240.3 .  160.7.1 - Assessing Patients Suitabilit y for Electrical Nerve Stimulation Therapy  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-46  Electrical nerve stimulation is an accepted modality for assessing a patients suitability for ongoing treatment with a transcutaneous  or an implanted nerve stimulator.   Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic useful ness of an electrical  nerve stimulator:  A.  Transcutaneous Electric al Nerve Stimulation (TENS)  This technique involves attachment of a transc utaneous nerve stimulat or to the surface of the skin over the peripheral nerve to be stimulated.  It is used by the patient on a trial basis and its effectiveness in modulating pain  is monitored by the physician, or physical therapist.  Generally, the physician or physical therapist is able to determine whether the patient is likely to derive a significant th erapeutic benefit from continuous use of a transcutaneous stimulator within a trial period of one month; in a few cases this determination may take longer to make.  Document the medical necessity for such services which are furnished beyond the first month.  (See 160.13  for an explanation of coverage of medically necessary supplies for the effective use of TENS.)
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If TENS significantly alleviates pain, it may be considered as primary treatment; if it produces no relief or greater discomfort than th e original pain electr ical nerve stimulation therapy is ruled out.  However, where TENS produces incomplete relief, further evaluation with percutaneous electrical nerve stimulation may be considered to determine whether an implanted peripheral nerve stimul ator would provide significant relief from pain.    Usually, the physician or physical therapist providing the services will furnish the equipment necessary for assessment.  Where the physician or physical therapist advises the patient to rent the TENS from a supplie r during the trial period rather than supplying it himself/herself, program payment may be ma de for rental of the TENS as well as for the services of the physician or physical therapist who is eval uating its use.  However, the combined program payment which is made for the physicians or physical therapists services and the rental of the stimulator from a supplier should not exceed the amount which would be payable for the total servic e, including the stimulator, furnished by the physician or physical therapist alone.  B.  Percutaneous Electrical Nerve Stimulation (PENS)  This diagnostic procedure which involves stimulation of peripheral nerves by a needle electrode inserted through the skin is perfor med only in a physicians office, clinic, or hospital outpatient department. Therefore,  it is covered only when performed by a physician or incident to physicians servic e. If pain is effectively controlled by percutaneous stimulation, implanta tion of electrodes is warranted.  As in the case of TENS (described in subsection A), generally the physician should be able to determine whether the patient is likely  to derive a significant therapeutic benefit from continuing use of an implanted nerve stimul ator within a trial period of 1 month.  In a few cases, this determination may take longer to make.  The medical necessity for such diagnostic services which are furnished be yond the first month must be documented.
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NOTE: Electrical nerve stimulators do not prevent pain but only alleviate pain as it occurs.  A patient can be taught how to empl oy the stimulator, and once this is done, can use it safely and effectively without direct physician superv ision.  Consequently, it is inappropriate for a patient to visit his/her phys ician, physical therapis t, or an outpatient clinic on a continuing basis for treatment of pain with electr ical nerve stimulation.  Once it is determined that electri cal nerve stimulation should be continued as therapy and the patient has been trained to use the stimulator , it is expected that a stimulator will be implanted or the patient will employ the TEN S on a continual basis in his/her home.  Electrical nerve stimulation tr eatments furnished by a physician in his/her office, by a physical therapist or outpatient clinic are excluded from coverage by 1862(a)(1)  of the Act.  (See 160.7  for an explanation of coverage of  the therapeutic use of implanted peripheral nerve stimulators under the prosthetic devices benefit.  See 280.13  for an explanation of coverage of the therapeutic use of TEN S under the durable medical equipment benefit.)  160.8 - Electroencephalographic Monitoring During Surgical Procedures Involving th e Cerebral Vasculature  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-57  Electroencephalographic (EEG) monitoring is  a safe and reliable technique for the assessment of gross cerebral blood flow during general anesthesia a nd is covered under Medicare.  Very characteristic changes in the EEG occur when cerebral perfusion is inadequate for ce rebral function. EEG monitoring as an indirect measure of cerebral perfusion requires the ex pertise of an electroencephalogr apher, a neurologist trained in EEG, or an advanced EEG technician for its proper interpretation.  The EEG monitoring may be covered routinely in carotid endarterectomies and in other neurological procedures where cerebral pe rfusion could be reduced.  Such other procedures might include aneurysm surgery where hypotensive anesthesia is used or other cerebral vascular procedures wher e cerebral blood flow may be interrupted.