Coverage Issues Manual

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1 Department f Health and Medicare Human Services (DHHS) HEALTH CARE FINANCING ADMINISTRATION (HCFA) Cverage Issues Manual Transmittal 125 Date: AUGUST 29, 2000 CHANGE REQUEST 1002 HEADER SECTION NUMBERS PAGES TO INSERT PAGES TO DELETE pp. 4 pp. NEW/REVISED MATERIAL--EFFECTIVE DATE: 10/01/00 IMPLEMENTATION DATE: 10/01/00 Sectin , Stem Cell Transplantatin, is revised t add the fllwing: (1) multiple myelma as a cvered cnditin nly fr beneficiaries less than age 78 wh have Durie-Salmn stage II r III newly diagnsed r respnsive multiple myelma and adequate cardiac, renal, pulmnary and hepatic functin; (2) nnprimary amylidsis as a nn-cvered cnditin; and (3) primary (AL) amylidsis as a nn-cvered cnditin fr Medicare beneficiaries age 64 and lder. Multiple runds f autlgus stem cell transplantatin (knwn as tandem transplantatin) fr patients with multiple myelma will, hwever, remain nn-cvered. These instructins shuld be implemented within yur current perating budget. DISCLAIMER: The revisin date and transmittal number nly apply t the redlined material. All ther material was previusly published in the manual and is nly being reprinted. This sectin f the cverage manual is a natinal cverage decisin made under 1862(a)(1) f the Scial Security Act (the Act). Natinal cverage determinatins are binding n all Medicare carriers, fiscal intermediaries, Peer Review Organizatins, Health Maintenance Organizatins, Cmpetitive Medical Plans, Health Care Prepayment Plans, and Medicare+Chice Organizatins ( 1852 (a)(1)(a) f the Act). An administrative law judge may nt disregard, set aside, r therwise review a natinal cverage decisin issued under 1862(a)(1) f the Act. 42 CFR

2 HCFA-Pub. 6

3 08-00 COVERAGE ISSUES - MEDICAL PROCEDURES TREATMENT OF OBESITY Obesity itself cannt be cnsidered an illness. The immediate cause is a calric intake which is persistently higher than calric utput. Prgram payment may nt be made fr treatment f besity alne since this treatment is nt reasnable and necessary fr the diagnsis r treatment f an illness r injury. Hwever, althugh besity is nt in itself an illness, it may be caused by illnesses such as hypthyridism, Cushing's disease, and hypthalamic lesins. In additin, besity can aggravate a number f cardiac and respiratry diseases as well as diabetes and hypertensin. Therefre, services in cnnectin with the treatment f besity are cvered services when such services are an integral and necessary part f a curse f treatment fr ne f these illnesses. Crss refer: CIM and SUPPLEMENTED FASTING Supplemented fasting is a type f very lw calrie weight reductin regimen used t achieve rapid weight lss. The reduced calrie intake is supplemented by a mixture f prtein, carbhydrates, vitamins and minerals. Serius questins exist abut the safety f prlnged adherence fr 2 mnths r mre t a very lw calrie weight reductin regimen as a general treatment fr besity, because f instances f cardipathlgy and sudden death, as well as pssible lss f bdy prtein. Therefre, supplemented fasting is nt cvered as a general treatment fr besity. In cases where weight lss is necessary befre surgery in rder t amelirate the cmplicatins psed by besity when it cexists with pathlgical cnditins such as cardiac and respiratry diseases, diabetes r hypertensin (and ther mre cnservative techniques t achieve this end are nt regarded as apprpriate), supplemented fasting with adequate mnitring f the patient are cvered under Medicare n a case-by-case basis, as determined by yur medical cnsultant. The risks assciated with the achievement f rapid weight lss must be carefully balanced against the risk psed by the cnditin requiring surgical treatment BIOFEEDBACK THERAPY Bifeedback therapy prvides visual, auditry r ther evidence f the status f certain bdy functins s that a persn can exert vluntary cntrl ver the functins, and thereby alleviate an abnrmal bdily cnditin. Bifeedback therapy ften uses electrical devices t transfrm bdily signals indicative f such functins as heart rate, bld pressure, skin temperature, salivatin, peripheral vasmtr activity, and grss muscle tne int a tne r light, the ludness r brightness f which shws the extent f activity in the functin being measured. Bifeedback therapy differs frm electrmygraphy, which is a diagnstic prcedure used t recrd and study the electrical prperties f skeletal muscle. An electrmygraphy device may be used t prvide feedback with certain types f bifeedback.

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5 35-29 COVERAGE ISSUES - MEDICAL PROCEDURES Bifeedback therapy is cvered under Medicare nly when it is reasnable and necessary fr the individual patient fr muscle re-educatin f specific muscle grups r fr treating pathlgical muscle abnrmalities f spasticity, incapacitating muscle spasm, r weakness, and mre cnventinal treatments (heat, cld, massage, exercise, supprt) have nt been successful. This therapy is nt cvered fr treatment f rdinary muscle tensin states r fr psychsmatic cnditins. (See HCFA-Pub. 14-3, 2200ff, 2215, and 4161; HCFA-Pub. 13-3, , 3148, and 3149; HCFA-Pub. 10, 242 and fr special physical therapy requirements. See als and 65-8.) OXYGEN TREATMENT OF INNER EAR/CARBON THERAPY (Effective fr services perfrmed n and after August 1, 1978).--NOT COVERED Oxygen (95 percent) and carbn dixide (5 percent) inhalatin therapy fr inner ear disease, such as endlymphatic hydrps and fluctuant hearing lss, is nt reasnable and necessary. The therapeutic benefit deriving frm this prcedure is highly questinable BLOOD PLATELET TRANSFUSIONS Effective fr services perfrmed n r after August 1, 1978, bld platelet transplants are safe and effective fr the crrectin f thrmbcytpenia and ther bld defects. It is cvered under Medicare when treatment is reasnable and necessary fr the individual patient STEM CELL TRANSPLANTATION Stem cell transplantatin is a prcess in which stem cells are harvested frm either a patient's r dnr's bne marrw r peripheral bld fr intravenus infusin. The transplant can be used t effect hematpietic recnstitutin fllwing severely myeltxic dses f chemtherapy (HDCT) and/r raditherapy used t treat varius malignancies. Allgeneic stem cell transplant may als be used t restre functin in recipients having an inherited r acquired deficiency r defect. A. Allgeneic Stem Cell Transplantatin.--Allgeneic stem cell transplantatin (ICD-9-CM prcedure cdes 41.02, 41.03, 41.05, and 41.08) is a prcedure in which a prtin f a healthy dnr's stem cell r bne marrw is btained and prepared fr intravenus infusin. 1. Cvered Cnditins.--The fllwing uses f allgeneic bne marrw transplantatin are cvered under Medicare: Effective fr services perfrmed n r after August 1, 1978, fr the treatment f leukemia, leukemia in remissin (ICD-9-CM cdes thrugh ), r aplastic anemia (ICD-9-CM cdes thrugh 284.9) when it is reasnable and necessary; and Effective fr services perfrmed n r after June 3, 1985, fr the treatment f severe cmbined immundeficiency disease (SCID) (ICD-9-CM cde 279.2), and fr the treatment f Wisktt - Aldrich syndrme (ICD-9-CM ). 2. Nncvered Cnditins.--Effective May 24, 1996, allgeneic stem cell transplantatin is nt cvered as treatment fr multiple myelma (ICD-9-CM cdes and 238.6). B. Autlgus Stem Cell Transplantatin (Effective fr Services Perfrmed n r After 04/28/89).--Autlgus stem cell transplantatin (ICD-9-CM prcedure cdes 41.01, 41.04, 41.07, and 41.09) is a technique fr restring stem cells using the patient's wn previusly stred cells. 1. Cvered Cnditins.--Autlgus stem cell transplantatin (ICD-9-CM cdes 41.01, 41.04, 41.07, 41.09, CPT-4 cde 38241) is cnsidered reasnable and necessary under l862(a)(1)(a) f the Act fr the fllwing cnditins and is cvered under Medicare fr patients with:

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7 08-00 COVERAGE ISSUES - MEDICAL PROCEDURES Acute leukemia in remissin (ICD-9-CM cdes , lymphid; , myelid; , mncytic; , acute erythremia and erythrleukemia; and unspecified cell type) wh have a high prbability f relapse and wh have n human leuccyte antigens (HLA)- matched; Resistant nn-hdgkin's lymphmas (ICD-9-CM cdes , , , , , , and ) r thse presenting with pr prgnstic features fllwing an initial respnse; malignant); r Recurrent r refractry neurblastma (see ICD-9-CM Neplasm by site, Advanced Hdgkin's disease (ICD-9-CM cdes ) wh have failed cnventinal therapy and have n HLA-matched dnr; Effective Octber 1, 2000, multiple myelma (ICD-9-CM and 238.6) fr beneficiaries less than age 78 wh have Durie-Salmn stage II r III newly diagnsed r respnsive multiple myelma with adequate cardiac, renal, pulmnary and hepatic functining. This includes thse patients with previusly untreated disease, thse with at least a partial respnse t prir chemtherapy (partial respnse is defined as a 50% decrease either in measurable paraprtein [serum and/r urine] r in bne marrw infiltratin, sustained fr at least ne mnth), and thse in respnsive relapse. Multiple runds f autlgus stem cell transplantatin (knwn as tandem transplantatin) will, hwever, remain nn-cvered. 2. Nncvered Cnditins.--Insufficient data exist t establish definite cnclusins regarding the efficacy f autlgus stem cell transplantatin fr the fllwing cnditins: Acute leukemia nt in remissin (ICD-9-CM cdes , , , and ); Chrnic granulcytic leukemia (ICD-9-CM cdes and ); Slid tumrs (ther than neurblastma) (ICD-9-CM cdes l99.1); Up t Octber 1, 2000, multiple myelma; Tandem transplantatin (multiple runds f autlgus stem cell transplantatin) fr patients with multiple myelma; Effective Octber 1, 2000, nn-primary (AL) amylidsis (ICD-9-CM 277.3); Effective Octber 1, 2000, primary (AL) amylidsis (ICD-9-CM 277.3) fr Medicare beneficiaries age 64 r lder. In these cases, autlgus stem cell transplantatin is nt cnsidered reasnable and necessary within the meaning f l862(a)(1)(a) f the Act and is nt cvered under Medicare TREATMENT OF DECUBITUS ULCERS An accepted prcedure fr healing decubitus ulcers is t remve dead tissue frm the lesins and t keep them clean t prmte the grwth f new tissue. This may be accmplished by hydrtherapy (whirlpl) treatments. Hydrtherapy (whirlpl) treatment fr decubitus ulcers is a cvered service under Medicare fr patients when treatment is reasnable and necessary. Sme ther methds f treating decubitus ulcers, the safety and effectiveness f which have nt been established, are nt cvered under the Medicare prgram. Sme examples f these types f treatments are: ultravilet light, lw intensity direct current, tpical applicatin f xygen, and tpical dressings with Balsam f Peru in castr il.

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9 35-32 COVERAGE ISSUES - MEDICAL PROCEDURES VERTEBRAL ARTERY SURGERY Obstructins which blck the flw f bld thrugh the vertebral artery can cause vertig, visual r speech defects, ataxia, mental cnfusin, r strke. These symptms in patients result frm reductin in bld flw t the brain and range frm symptms f transient basilar ischemia t mental deteriratin r cmpleted strke. Five types f surgical prcedures are perfrmed t relieve bstructins t vertebral artery bld flw. They are: Vertebral artery endarterectmy, a prcedure which cleans ut arterisclertic plaques which are inside the vertebral artery; Vertebral artery by-pass r resectin with anastmsis r graft; Subclavian artery resectin with r withut endarterectmy; Remval f laterally lcated stephytes anywhere in the C6(C7)-C2 curse f the vertebral artery; and Arterilysis which frees the artery frm surrunding tissue, with r withut arteripexy (fixatin f the vessel). These prcedures can be medically reasnable and necessary, but nly if each f the fllwing cnditins is met: Symptms f vertebral artery bstructin exist; Other causes have been cnsidered and ruled ut; There is radigraphic evidence f a valid vertebral artery bstructin; and Cntraindicatins t the prcedure d nt exist, such as cexistent bstructins f multiple cerebral vessels. Angigrams dcumenting a valid bstructin shuld shw nt nly the artic arch with the vessels ff the arch, but als shw the vessels in the neck and head (prviding biplane views f the cartid and vertebral vascular system). In additin, serial views are needed t diagnse "subclavian steal," the cnditin in which subclavian artery bstructin causes the symptms f vertebral artery bstructin. Because the symptms are nt specific fr vertebral artery bstructin, ther causes must be cnsidered. In additin t vertebral artery bstructin, the differential diagnsis shuld include varius degenerative disrders f the brain, rthstatic hyptensin, acustic neurma, labyrinthitis, diabetes mellitus and hypglycemia related disrders. Obstructins which can cause symptms f blcked vertebral artery bld flw and which can be dcumented by an angigram include: arteries. Intravascular bstructins - arterisclertic lesins within the vertebral artery r in ther Extravascular bstructins -

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