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Instructions and guideline for CMS 1500 claim form and UB 04 form. Tips and updates. Detailed review of all the fields and box in CMS 1500 claim form and UB 04 form and ADA form. HCFA 1500 and UB 92 form instruction.

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  • 09/19/17--04:46: icd 10 code for dermatitis

  • Viral infections characterized by skin and mucous membrane lesions (B00-B09) 

    B00 Herpesviral [herpes simplex] infections

    Excludes1: congenital herpesviral infections (P35.2)

    Excludes2: anogenital herpesviral infection (A60.-) gammaherpesviral mononucleosis (B27.0-) herpangina (B08.5)

    B00.0 Eczema herpeticum Kaposi's varicelliform eruption

    B00.1 Herpesviral vesicular dermatitis

    Herpes simplex facialis
    Herpes simplex labialis
    Herpes simplex otitis externa
    Vesicular dermatitis of ear
    Vesicular dermatitis of lip

    B00.2 Herpesviral gingivostomatitis and pharyngotonsillitis Herpesviral pharyngitis
    B00.3 Herpesviral meningitis
    B00.4 Herpesviral encephalitis Herpesviral meningoencephalitis Simian B disease Excludes1: herpesviral encephalitis due to herpesvirus 6 and 7 (B10.01,
    B10.09) non-simplex herpesviral encephalitis (B10.0-)
    B00.5 Herpesviral ocular disease
    B00.50 Herpesviral ocular disease, unspecified
    B00.51 Herpesviral iridocyclitis Herpesviral iritis  Herpesviral uveitis, anterior
    B00.52 Herpesviral keratitis Herpesviral keratoconjunctivitis
    B00.53 Herpesviral conjunctivitis
    B00.59 Other herpesviral disease of eye Herpesviral dermatitis of eyelid
    B00.7 Disseminated herpesviral disease Herpesviral sepsis
    B00.8 Other forms of herpesviral infections
    B00.81 Herpesviral hepatitis
    B00.82 Herpes simplex myelitis
    B00.89 Other herpesviral infection Herpesviral whitlow
    B00.9 Herpesviral infection, unspecified Herpes simplex infection NOS
    B08 Other viral infections characterized by skin and mucous membrane lesions, not elsewhere classified

    Excludes1: vesicular stomatitis virus disease (A93.8)

    B08.0 Other orthopoxvirus infections

    Excludes2: monkeypox (B04)

    B08.01 Cowpox and vaccinia not from vaccine
    B08.010 Cowpox
    B08.011 Vaccinia not from vaccine Excludes1: vaccinia (from vaccination) (generalized) (T88.1)
    B08.02 Orf virus disease Contagious pustular dermatitis Ecthyma contagiosum
    B08.03 Pseudocowpox [milker's node]
    B08.04 Paravaccinia, unspecified
    B08.09 Other orthopoxvirus infections Orthopoxvirus infection NOS
    B08.1 Molluscum contagiosum
    B08.2 Exanthema subitum [sixth disease] Roseola infantum
    B08.20 Exanthema subitum [sixth disease], unspecified Roseola infantum, unspecified
    B08.21 Exanthema subitum [sixth disease] due to human herpesvirus 6 Roseola infantum due to human herpesvirus 6

    B37 Candidiasis Includes: candidosis moniliasis

    Excludes1: neonatal candidiasis (P37.5)
    B37.0 Candidal stomatitis Oral thrush
    B37.1 Pulmonary candidiasis Candidal bronchitis Candidal pneumonia
    B37.2 Candidiasis of skin and nail Candidal onychia Candidal paronychia

    Excludes2: diaper dermatitis (L22)

    B37.3 Candidiasis of vulva and vagina Candidal vulvovaginitis Monilial vulvovaginitis Vaginal thrush
    B37.4 Candidiasis of other urogenital sites
    B37.41 Candidal cystitis and urethritis
    B37.42 Candidal balanitis
    B37.49 Other urogenital candidiasis Candidal pyelonephritis
    B37.5 Candidal meningitis
    B37.6 Candidal endocarditis
    B37.7 Candidal sepsis Disseminated candidiasis Systemic candidiasis
    B37.8 Candidiasis of other sites
    B37.81 Candidal esophagitis
    B37.82 Candidal enteritis Candidal proctitis
    B37.83 Candidal cheilitis
    B37.84 Candidal otitis externa
    B37.89 Other sites of candidiasis Candidal osteomyelitis
    B37.9 Candidiasis, unspecified Thrush NOS

    Helminthiases (B65-B83)

    B65 Schistosomiasis [bilharziasis]

    Includes: snail fever

    B65.0 Schistosomiasis due to Schistosoma haematobium [urinary schistosomiasis]
    B65.1 Schistosomiasis due to Schistosoma mansoni [intestinal schistosomiasis]
    B65.2 Schistosomiasis due to Schistosoma japonicum Asiatic schistosomiasis
    B65.3 Cercarial dermatitis Swimmer's itch
    B65.8 Other schistosomiasis
    Infection due to Schistosoma intercalatum
    Infection due to Schistosoma mattheei
    Infection due to Schistosoma mekongi

    B65.9 Schistosomiasis, unspecified

    B88 Other infestations
    B88.0 Other acariasis
    Acarine dermatitis
    Dermatitis due to Demodex species
    Dermatitis due to Dermanyssus gallinae
    Dermatitis due to Liponyssoides sanguineus
    Trombiculosis

    Excludes2: scabies (B86)

    B88.1 Tungiasis [sandflea infestation]

    B88.2 Other arthropod infestations Scarabiasis

    B88.3 External hirudiniasis Leech infestation NOS

    Excludes2: internal hirudiniasis (B83.4)
    B88.8 Other specified infestations Ichthyoparasitism due to Vandellia cirrhosa Linguatulosis Porocephaliasis
    B88.9 Infestation, unspecified Infestation (skin) NOS Infestation by mites NOS Skin parasites NOS

    D89.8 Other specified disorders involving the immune mechanism, not elsewhere classified
    D89.81 Graft-versus-host disease Code first underlying cause, such as: complications of transplanted organs and tissue (T86.-) complications of blood transfusion (T80.89)

    Use additional code to identify associated manifestations, such as: desquamative dermatitis (L30.8) diarrhea (R19.7) elevated bilirubin (R17) hair loss (L65.9)

    D89.810 Acute graft-versus-host disease
    D89.811 Chronic graft-versus-host disease
    D89.812 Acute on chronic graft-versus-host disease
    D89.813 Graft-versus-host disease, unspecified
    D89.82 Autoimmune lymphoproliferative syndrome [ALPS]
    D89.89 Other specified disorders involving the immune mechanism, not elsewhere classified
    Excludes1: human immunodeficiency virus disease (B20)
    D89.9 Disorder involving the immune mechanism, unspecified

    Immune disease NOS

    E08.6 Diabetes mellitus due to underlying condition with other specified complications
    E08.61 Diabetes mellitus due to underlying condition with diabetic arthropathy
    E08.610 Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy Diabetes mellitus due to underlying condition with Charcot's joints
    E08.618 Diabetes mellitus due to underlying condition with other diabetic arthropathy
    E08.62 Diabetes mellitus due to underlying condition with skin complications
    E08.620 Diabetes mellitus due to underlying condition with diabetic dermatitis Diabetes mellitus due to underlying condition with diabetic necrobiosis lipoidica
    E08.621 Diabetes mellitus due to underlying condition with foot ulcer Use additional code to identify site of ulcer (L97.4-, L97.5-)
    E08.622 Diabetes mellitus due to underlying condition with other skin ulcer Use additional code to identify site of ulcer (L97.1-
    L97.9, L98.41-L98.49)
    E08.628 Diabetes mellitus due to underlying condition with other skin complications
    E08.63 Diabetes mellitus due to underlying condition with oral complications
    E08.630 Diabetes mellitus due to underlying condition with periodontal disease
    E08.638 Diabetes mellitus due to underlying condition with other oral complications
    E08.64 Diabetes mellitus due to underlying condition with hypoglycemia
    E08.641 Diabetes mellitus due to underlying condition with hypoglycemia with coma
    E08.649 Diabetes mellitus due to underlying condition with hypoglycemia without coma

    E08.65 Diabetes mellitus due to underlying condition with hyperglycemia
    E08.69 Diabetes mellitus due to underlying condition with other specified complication Use additional code to identify complication
    E08.8 Diabetes mellitus due to underlying condition with unspecified complications
    E08.9 Diabetes mellitus due to underlying condition without complications

    E10.6 Type 1 diabetes mellitus with other specified complications
    E10.61 Type 1 diabetes mellitus with diabetic arthropathy
    E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy

    Type 1 diabetes mellitus with Charcot's joints

    E10.618 Type 1 diabetes mellitus with other diabetic arthropathy
    E10.62 Type 1 diabetes mellitus with skin complications
    E10.620 Type 1 diabetes mellitus with diabetic dermatitis Type 1 diabetes mellitus with diabetic necrobiosis lipoidica
    E10.621 Type 1 diabetes mellitus with foot ulcer Use additional code to identify site of ulcer (L97.4-, L97.5-)
    E10.622 Type 1 diabetes mellitus with other skin ulcer Use additional code to identify site of ulcer (L97.1-
    L97.9, L98.41-L98.49)
    E10.628 Type 1 diabetes mellitus with other skin complications
    E10.63 Type 1 diabetes mellitus with oral complications
    E10.630 Type 1 diabetes mellitus with periodontal disease
    E10.638 Type 1 diabetes mellitus with other oral complications
    E10.64 Type 1 diabetes mellitus with hypoglycemia
    E10.641 Type 1 diabetes mellitus with hypoglycemia with coma
    E10.649 Type 1 diabetes mellitus with hypoglycemia without coma

    E13.6 Other specified diabetes mellitus with other specified complications

    E13.61 Other specified diabetes mellitus with diabetic arthropathy

    E13.610 Other specified diabetes mellitus with
    diabetic neuropathic arthropathy
    Other specified diabetes mellitus with Charcot's joints

    E13.618 Other specified diabetes mellitus with other diabetic arthropathy

    E13.62 Other specified diabetes mellitus with skin complications

    E13.620 Other specified diabetes mellitus with diabetic dermatitis Other specified diabetes mellitus with diabetic necrobiosis lipoidica
    E13.621 Other specified diabetes mellitus with foot ulcer Use additional code to identify site of ulcer (L97.4-, L97.5-)
    E13.622 Other specified diabetes mellitus with other skin ulcer Use additional code to identify site of ulcer (L97.1- L97.9, L98.41-L98.49)
    E13.628 Other specified diabetes mellitus with other skin complications
    E13.63 Other specified diabetes mellitus with oral complications
    E13.630 Other specified diabetes mellitus with periodontal disease
    E83.1 Disorders of iron metabolism
    Excludes1: iron deficiency anemia (D50.-) sideroblastic anemia (D64.0-D64.3)
    E83.10 Disorder of iron metabolism, unspecified
    E83.11 Hemochromatosis
    E83.19 Other disorders of iron metabolism
    E83.2 Disorders of zinc metabolism Acrodermatitis enteropathica
    E83.3 Disorders of phosphorus metabolism and phosphatases

    Excludes1: adult osteomalacia (M83.-) osteoporosis (M80-)

    E83.30 Disorder of phosphorus metabolism, unspecified

    E83.31 Familial hypophosphatemia

    Vitamin D-resistant osteomalacia
    Vitamin D-resistant rickets

    Excludes1: vitamin D-deficiency rickets (E55.0)

    E83.32 Hereditary vitamin D-dependent rickets (type 1) (type 2) 25-hydroxyvitamin D 1-alpha-hydroxylase deficiency Pseudovitamin D deficiency Vitamin D receptor defect

    E83.39 Other disorders of phosphorus metabolism
    Acid phosphatase deficiency Hypophosphatasia

    E83.4 Disorders of magnesium metabolism
    E83.40 Disorders of magnesium metabolism, unspecified
    E83.41 Hypermagnesemia
    E83.42 Hypomagnesemia
    E83.49 Other disorders of magnesium metabolism
    E83.5 Disorders of calcium metabolism

    Excludes1: chondrocalcinosis (M11.1-M11.2) hungry bone syndrome (E83.81) hyperparathyroidism (E21.0-E21.3)

    E83.50 Unspecified disorder of calcium metabolism
    E83.51 Hypocalcemia
    E83.52 Hypercalcemia Familial hypocalciuric hypercalcemia
    E83.59 Other disorders of calcium metabolism Idiopathic hypercalciuria
    E83.8 Other disorders of mineral metabolism
    E83.81 Hungry bone syndrome
    E83.89 Other disorders of mineral metabolism
    E83.9 Disorder of mineral metabolism, unspecified
    F54 Psychological and behavioral factors associated with
    disorders or diseases classified elsewhere
    Psychological factors affecting physical conditions

    Code first the associated physical disorder, such as:

    asthma (J45.-)
    dermatitis (L23-L25)
    gastric ulcer (K25.-)
    mucous colitis (K58.-)
    ulcerative colitis (K51.-)
    urticaria (L50.-)

    Excludes2: tension-type headache (G44.2)

    F68 Other disorders of adult personality and behavior

    F68.1 Factitious disorder Compensation neurosis

    Elaboration of physical symptoms for psychological reasons Hospital hopper syndrome M?nchhausen's syndrome Peregrinating patient

    Excludes2: factitial dermatitis (L98.1) person feigning illness (with obvious motivation) (Z76.5)

    F68.10 Factitious disorder, unspecified

    F68.11 Factitious disorder with predominantly psychological signs and symptoms

    F68.12 Factitious disorder with predominantly physical signs and symptoms

    F68.13 Factitious disorder with combined psychological and physical signs and symptoms

    F68.8 Other specified disorders of adult personality and behavior

    H01.1 Noninfectious dermatoses of eyelid

    H01.11 Allergic dermatitis of eyelid Contact dermatitis of eyelid

    H01.111 Allergic dermatitis of right upper eyelid
    H01.112 Allergic dermatitis of right lower eyelid
    H01.113 Allergic dermatitis of right eye, unspecified eyelid
    H01.114 Allergic dermatitis of left upper eyelid
    H01.115 Allergic dermatitis of left lower eyelid
    H01.116 Allergic dermatitis of left eye, unspecified eyelid
    H01.119 Allergic dermatitis of unspecified eye, unspecified eyelid
    H01.12 Discoid lupus erythematosus of eyelid
    H01.121 Discoid lupus erythematosus of right upper eyelid
    H01.122 Discoid lupus erythematosus of right lower eyelid
    H01.123 Discoid lupus erythematosus of right eye, unspecified eyelid
    H01.124 Discoid lupus erythematosus of left upper eyelid
    H01.125 Discoid lupus erythematosus of left lower eyelid
    H01.126 Discoid lupus erythematosus of left eye, unspecified eyelid
    H01.129 Discoid lupus erythematosus of unspecified eye, unspecified eyelid
    H01.13 Eczematous dermatitis of eyelid
    H01.131 Eczematous dermatitis of right upper eyelid
    H01.132 Eczematous dermatitis of right lower eyelid
    H01.133 Eczematous dermatitis of right eye, unspecified eyelid
    H01.134 Eczematous dermatitis of left upper eyelid
    H01.135 Eczematous dermatitis of left lower eyelid
    H01.136 Eczematous dermatitis of left eye, unspecified eyelid
    H01.139 Eczematous dermatitis of unspecified eye, unspecified eyelid
    H01.14 Xeroderma of eyelid
    H01.141 Xeroderma of right upper eyelid
    H01.142 Xeroderma of right lower eyelid
    H01.143 Xeroderma of right eye, unspecified eyelid
    H01.144 Xeroderma of left upper eyelid
    H01.145 Xeroderma of left lower eyelid
    H01.146 Xeroderma of left eye, unspecified eyelid
    H01.149 Xeroderma of unspecified eye, unspecified eyelid
    H01.8 Other specified inflammations of eyelid
    H61 Other disorders of external ear
    H61.0 Chondritis and perichondritis of external ear Chondrodermatitis nodularis chronica helicis

    Perichondritis of auricle
    Perichondritis of pinna

    H61.00 Unspecified perichondritis of external ear
    H61.001 Unspecified perichondritis of right external ear
    H61.002 Unspecified perichondritis of left external ear
    H61.003 Unspecified perichondritis of external ear, bilateral
    H61.009 Unspecified perichondritis of external ear, unspecified ear
    H61.01 Acute perichondritis of external ear
    H61.011 Acute perichondritis of right external ear
    H61.012 Acute perichondritis of left external ear
    H61.013 Acute perichondritis of external ear, bilateral
    H61.019 Acute perichondritis of external ear, unspecified ear
    H61.02 Chronic perichondritis of external ear
    I83.1 Varicose veins of lower extremities with inflammation Stasis dermatitis
    I83.10 Varicose veins of unspecified lower extremity with inflammation
    I83.11 Varicose veins of right lower extremity with inflammation
    I83.12 Varicose veins of left lower extremity with inflammation
    L10-L14 Bullous disorders
    L20-L30 Dermatitis and eczema
    L40-L45 Papulosquamous disorders
    L49-L54 Urticaria and erythema
    L55-L59 Radiation-related disorders of the skin and subcutaneous tissue
    L60-L75 Disorders of skin appendages
    L76 Intraoperative and postprocedural complications of skin and subcutaneous tissue

    L80-L99 Other disorders of the skin and subcutaneous tissue

    Infections of the skin and subcutaneous tissue (L00- L08)

    Use additional code (B95-B97) to identify infectious agent.

    Excludes2: hordeolum (H00.0)

    infective dermatitis (L30.3)

    local infections of skin classified in Chapter 1

    lupus panniculitis (L93.2)

    panniculitis NOS (M79.3)

    panniculitis of neck and back (M54.0-)

    perl?che NOS (K13.0)

    perl?che due to candidiasis (B37.0)

    perl?che due to riboflavin deficiency (E53.0)

    pyogenic granuloma (L98.0)

    relapsing panniculitis [Weber-Christian] (M35.6)

    viral warts (B07.-)

    zoster (B02.-) 

    L08.0 Pyoderma Purulent dermatitis Septic dermatitis Suppurative dermatitis

    Excludes1: pyoderma gangrenosum (L88) pyoderma vegetans (L08.81)

    L12 Pemphigoid

    Excludes1: herpes gestationis (O26.4-) impetigo herpetiformis (L40.1)

    L12.0 Bullous pemphigoid

    L12.1 Cicatricial pemphigoid Benign mucous membrane pemphigoid

    L12.2 Chronic bullous disease of childhood Juvenile dermatitis herpetiformis

    L12.3 Acquired epidermolysis bullosa

    Excludes1: epidermolysis bullosa (congenital) (Q81.-)

    L12.30 Acquired epidermolysis bullosa, unspecified

    L12.31 Epidermolysis bullosa due to drug

    Code first (T36-T50) to identify drug

    L12.35 Other acquired epidermolysis bullosa

    L12.8 Other pemphigoid

    L12.9 Pemphigoid, unspecified

    L13 Other bullous disorders

    L13.0 Dermatitis herpetiformis Duhring's disease

    Hydroa herpetiformis

    Excludes1: juvenile dermatitis herpetiformis (L12.2) senile dermatitis herpetiformis (L12.0)

    L13.1 Subcorneal pustular dermatitis Sneddon-Wilkinson disease

    L13.8 Other specified bullous disorders

    L13.9 Bullous disorder, unspecified  Dermatitis and eczema (L20-L30)

    Note: In this block the terms dermatitis and eczema are used synonymously and interchangeably.

    Excludes2: chronic (childhood) granulomatous disease (D71)

    dermatitis gangrenosa (L88)

    dermatitis herpetiformis (L13.0)

    dry skin dermatitis (L85.3)

    factitial dermatitis (L98.1)

    perioral dermatitis (L71.0)

    radiation-related disorders of the skin and subcutaneous tissue (L55-L59) stasis dermatitis (I83.1-I83.2)

    L20 Atopic dermatitis

    L20.0 Besnier's prurigo

    L20.8 Other atopic dermatitis

    Excludes2: circumscribed neurodermatitis (L28.0)

    L20.81 Atopic neurodermatitis Diffuse neurodermatitis

    L20.82 Flexural eczema

    L20.83 Infantile (acute) (chronic) eczema

    L20.84 Intrinsic (allergic) eczema

    L20.89 Other atopic dermatitis

    L20.9 Atopic dermatitis, unspecified

    L21 Seborrheic dermatitis

    Excludes2: infective dermatitis (L30.3)

    seborrheic keratosis (L82.-)

    L21.0 Seborrhea capitis Cradle cap

    L21.1 Seborrheic infantile dermatitis

    L21.8 Other seborrheic dermatitis

    L21.9 Seborrheic dermatitis, unspecified

    Seborrhea NOS

    L22 Diaper dermatitis

    Includes: Diaper erythema

    Diaper rash

    Psoriasiform diaper rash

    L23 Allergic contact dermatitis

    Code first (T36-T65), to identify drug or substance

    Excludes1: allergy NOS (T78.40)

    contact dermatitis NOS (L25.9)

    dermatitis NOS (L30.9)

    Excludes2: dermatitis due to substances taken internally (L27.-)

    dermatitis of eyelid (H01.1-)

    diaper dermatitis (L22)

    eczema of external ear (H60.5-)

    irritant contact dermatitis (L24.-)

    perioral dermatitis (L71.0)

    radiation-related disorders of the skin and subcutaneous tissue (L55- L59)

    L23.0 Allergic contact dermatitis due to metals

    Allergic contact dermatitis due to chromium

    Allergic contact dermatitis due to nickel

    L23.1 Allergic contact dermatitis due to adhesives

    L23.2 Allergic contact dermatitis due to cosmetics

    L23.3 Allergic contact dermatitis due to drugs in contact with skin

    Excludes2: dermatitis due to ingested drugs and medicaments (L27.0- L27.1)

    L23.4 Allergic contact dermatitis due to dyes

    L23.5 Allergic contact dermatitis due to other chemical products

    Allergic contact dermatitis due to cement

    Allergic contact dermatitis due to insecticide

    Allergic contact dermatitis due to plastic

    Allergic contact dermatitis due to rubber

    L23.6 Allergic contact dermatitis due to food in contact with the skin

    Excludes2: dermatitis due to ingested food (L27.2)

    L23.7 Allergic contact dermatitis due to plants, except food

    Excludes2: allergy NOS due to pollen (J30.1)

    L23.8 Allergic contact dermatitis due to other agents

    L23.81 Allergic contact dermatitis due to animal (cat) (dog) dander

    Allergic contact dermatitis due to animal (cat) (dog) hair

    L23.89 Allergic contact dermatitis due to other agents

    L23.9 Allergic contact dermatitis, unspecified cause

    Allergic contact eczema NOS

    L24 Irritant contact dermatitis

    Code first (T36-T65) to identify drug or substance

    Excludes1: allergy NOS (T78.40)

    contact dermatitis NOS (L25.9)

    dermatitis NOS (L30.9)

    Excludes2: allergic contact dermatitis (L23.-)

    dermatitis due to substances taken internally (L27.-)

    dermatitis of eyelid (H01.1-)

    diaper dermatitis (L22)

    eczema of external ear (H60.5-)

    perioral dermatitis (L71.0)

    radiation-related disorders of the skin and subcutaneous tissue (L55- L59)

    L24.0 Irritant contact dermatitis due to detergents

    L24.1 Irritant contact dermatitis due to oils and greases

    L24.2 Irritant contact dermatitis due to solvents

    Irritant contact dermatitis due to chlorocompound

    Irritant contact dermatitis due to cyclohexane

    Irritant contact dermatitis due to ester

    Irritant contact dermatitis due to glycol

    Irritant contact dermatitis due to hydrocarbon

    Irritant contact dermatitis due to ketone

    L24.3 Irritant contact dermatitis due to cosmetics

    L24.4 Irritant contact dermatitis due to drugs in contact with skin

    L24.5 Irritant contact dermatitis due to other chemical products

    Irritant contact dermatitis due to cement

    Irritant contact dermatitis due to insecticide

    Irritant contact dermatitis due to plastic

    Irritant contact dermatitis due to rubber

    L24.6 Irritant contact dermatitis due to food in contact with skin

    Excludes2: dermatitis due to ingested food (L27.2)

    L24.7 Irritant contact dermatitis due to plants, except food

    Excludes2: allergy NOS to pollen (J30.1)

    L24.8 Irritant contact dermatitis due to other agents

    L24.81 Irritant contact dermatitis due to metals

    Irritant contact dermatitis due to chromium

    Irritant contact dermatitis due to nickel

    L24.89 Irritant contact dermatitis due to other agents Irritant contact dermatitis due to dyes

    L24.9 Irritant contact dermatitis, unspecified cause Irritant contact eczema NOS

    L25 Unspecified contact dermatitis

    Code first (T36-T65), to identify drug or substance

    Excludes1: allergic contact dermatitis (L23.-)

    allergy NOS (T78.40)

    dermatitis NOS (L30.9)

    irritant contact dermatitis (L24.-)

    Excludes2: dermatitis due to ingested substances (L27.-)

    dermatitis of eyelid (H01.1-)

    eczema of external ear (H60.5-)

    perioral dermatitis (L71.0)

    radiation-related disorders of the skin and subcutaneous tissue (L55- L59)

    L25.0 Unspecified contact dermatitis due to cosmetics

    L25.1 Unspecified contact dermatitis due to drugs in contact with skin

    Excludes2: dermatitis due to ingested drugs and medicaments (L27.0- L27.1)

    L25.2 Unspecified contact dermatitis due to dyes

    L25.3 Unspecified contact dermatitis due to other chemical products

    Unspecified contact dermatitis due to cement

    Unspecified contact dermatitis due to insecticide

    L25.4 Unspecified contact dermatitis due to food in contact with skin

    Excludes2: dermatitis due to ingested food (L27.2)
    L25.5 Unspecified contact dermatitis due to plants, except food

    Excludes1: nettle rash (L50.9)

    Excludes2: allergy NOS due to pollen (J30.1)

    L25.8 Unspecified contact dermatitis due to other agents
    L25.9 Unspecified contact dermatitis, unspecified cause
    Contact dermatitis (occupational) NOS
    Contact eczema (occupational) NOS



    0 0

    BILLING INSTRUCTIONS FOR HOSPICE CLAIM COMPLETION

    Use UB 04 form

    * Admission Date: Include the admission date for hospice care.

    * Inpatient Respite Care: "Occurrence Span Code" - include occurrence span code M2 and complete the "from and through" dates for an episode of inpatient respite care.

    * Core Based Statistical Area (CBSA): "Value Codes" - include value code 61 in the value code field and report the CBSA number. Hospice claims must be reported with a valid CBSA code based on the location of the beneficiary receiving services.

    * Use the Revenue Codes listed below:

    Revenue Code Description

    0651 Routine Home Care I

    0652 Continuous Home Care

    0655 Inpatient Respite Care

    0656 General Inpatient Care

    0657 Physician Services

    0658 Other Hospice I (Room & Board)

    0659 Other Hospice Service – Facility Innovative Design


    Supplemental (FIDS) Bed

    * To bill for room and board in a nursing facility, licensed hospice long-term care unit, or Ventilator Dependent Care Unit (VDCU), use Revenue Code 0658. Providers must bill their customary room and board rate and Medicaid pays the usual and customary rate or the Medicaid fee screen, whichever is less. Room and board is reimbursable on the day of discharge if the discharge is due to resident death or the resident is discharged from hospice but remains in the NF. NOTE:

    To ensure proper payment for a beneficiary in a VDCU, the VDCU provider identification number must be on the Hospice Membership Notice (DCH-1074). When a beneficiary resides in a VDCU/Dialysis Unit under which the VDCU has a special agreement with Medicaid and elects hospice, a prior authorization (PA) number for hospice is not required.

    * To bill for room and board in a nursing facility when the beneficiary resides in a Facility Innovative Design Supplemental (FIDS) bed, use Revenue Code 0659.

    * Revenue Code 0657 Physician Services requires inclusion of a HCPCS code on the claim line. Each Physician service must be billed on a separate claim line.

    * Revenue Code 0652 Continuous Home Care must be billed for each date of service on separate claim lines. To receive the Continuous Home Care rate under code 0652, a minimum of 8 hours1 of care, not necessarily consecutive, in a 24-hour period is required. Less than 8 hours is reported under code 0651. A portion of an hour counts as an hour for this determination.

    * Hospital Leave Days must be billed using Revenue Code 0185 (must not exceed 10 consecutive days). Reimbursement is at 100 percent of class-wide Nursing Facility Hospital Leave Day rate for qualifying facilities.

    * Therapeutic Leave Days must be billed using Revenue Code 0183 (must not exceed 18 total days for the year) or Revenue Code 0189, Therapeutic Leave Days, for a beneficiary in a Facility Innovative Design Supplemental (FIDS) bed. Reimbursement is at 95 percent of Nursing Facility rate for leave days.

    * Hospice services are reimbursable for day of discharge if services were rendered, regardless of the setting in which the services were provided. (See first bullet for instructions regarding room and board.)

    * When billing for a hospice/NF resident who has been approved for complex care, bill revenue code 0120 and include the assigned PA number in F.L. 84, as obtained from the NF.

    The Michigan Medicaid program, including Medicaid Health Plans (MHPs) and MIChild, as well as CSHCS, covers hospice care for children under 21 years of age concurrently with curative treatment of the child’s terminal illness when the child qualifies for hospice as described in the Hospice Chapter of this manual.


    Hospice services and curative treatment are billed and reimbursed separately under this policy. Prior to billing, it is important that providers differentiate between services that are palliative and therefore included in hospice reimbursement, and those that are curative and separately reimbursable under Medicaid. Each child’s circumstances will need to be taken into consideration when making this distinction. Caution should be taken to avoid billing both the hospice and Medicaid for the same service as this represents double billing and may constitute fraud.

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    GENERAL INFORMATION


    The following providers must use the ASC X12N 837 5010 professional format when submitting electronic claims and the CMS 1500 claim form for paper claims.


    * Ambulance

    * Ambulatory Surgical Centers

    * Anesthesiologist Assistants

    * Certified Nurse Midwives

    * Certified Nurse Practitioners

    * Certified Registered Nurse

    Anesthetists

    * Chiropractors

    * Community Mental Health Services Programs/Prepaid Inpatient Health Plans

    * Family Planning Clinics

    * Federally Qualified Health Centers

    * Hearing Aid Dealers

    * Hearing Centers

    * Independent Laboratories

    * Indian Health Centers

    * Maternal Infant Health Program

    * Medical Clinics

    * Medical Suppliers

    * Optical Companies

    * Optometrists

    * Oral-Maxillofacial Surgeons

    * Orthotists and Prosthetists

    * Physician Assistants

    * Physical Therapists

    * Physicians (MD & DO)

    * Podiatrists

    * Private Duty Nurses (Individually Enrolled)

    * Rural Health Clinics

    * School Based Services

    * Shoe Stores

    * Urgent Care Centers

    Claims for services rendered as a result of an order or referral must contain the name and individual NPI of the provider who ordered or referred the service/item. The following are the authorized health professionals who may order, prescribe or refer services to Medicaid beneficiaries:

    * Physician

    * Physician Assistant

    * Nurse Practitioner

    * Certified Nurse Midwife

    * Dentist

    * Podiatrist

    * Optometrist

    * Chiropractor (limited to spinal x-rays only)

    Examples of services that require an order, prescription or referral include, but are not limited to,:

    * Ambulance non-emergency transports

    * Ancillary services for beneficiaries residing in nursing facilities (e.g., chiropractic, dental, podiatry, vision)

    * Childbirth/parenting and diabetes self-management education

    * Consultations

    * Diagnostic radiology services, unless rendered by the ordering physician

    * Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)

    * Hearing and hearing aid dealer services

    * Home health services

    * Hospice services

    * Laboratory services

    * Certain mental health and substance abuse children's waiver services

    * Certain Maternal Infant Health Program (MIHP) services

    * Pharmacy services

    * Private Duty Nursing services

    * Certain School Based Services

    * Therapy services (occupational therapy (OT), physical therapy (PT) and speech)

    * Certain vision supplies

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     MATERNITY CARE SERVICES

    Coding CPT guidelines for reporting prenatal care and delivery services apply. Bill the global obstetrical package or the antepartum, delivery, and postpartum components as  appropriate per Medicaid NCCI guidelines.



    Delivery Delivery is part of the global maternity package and should not be billed separately if the global package is billed. If the beneficiary is seen for fewer than seven antepartum visits, delivery and postpartum care should be billed separately. Use appropriate CPT guidelines.

    Global Service The global maternity package should be billed if the beneficiary is seen for seven or more antepartum visits with delivery and postpartum performed by the same physician or physician group. The provider or group may choose to bill the antepartum, delivery, and postpartum components separately as allowed by Medicaid NCCI editing.

    Multiple Gestation For twin gestation, report the service on two lines with no modifier on the first line and modifier 51 on the second line. If all maternity care was provided, report the global maternity package code for the first infant, and report the appropriate delivery-only code for the second infant using modifier 51. If multiple gestation for more than twins is encountered, report the first delivery on one line and combine all subsequent deliveries on the second line with modifiers 51 and 22. Provide information in the remarks section or submit an attachment to the claim explaining the number of babies delivered.


    Physician Change During Antepartum Care

    If the beneficiary changes physicians during the antepartum care (other than physicians within the same group), use the appropriate maternity CPT codes and guidelines for the services performed. The global package should not be billed by either physician regardless of the number of antepartum visits provided.

    Postpartum Care Postpartum care is included in the global maternity package and in the global surgical delivery period when the services are provided by the same physician or physician group. When the postpartum exam is performed by a physician not billing the global package or performing the delivery, the postpartum exam may be billed as a separate service.

    Prenatal/Antepartum Care

    If the beneficiary receives fewer than seven but greater than three antepartum visits, use the appropriate antepartum CPT code. Individual E/M codes should be used when three or fewer antepartum visits are performed.

    NEWBORN CARE

    When billing for medical services provided to the newborn, providers must use the newborn's Medicaid ID number, except if the delivering physician performs the newborn care and circumcision during the mother's inpatient stay, the delivering physician may bill for the newborn care and circumcision on the same claim as the delivery under the mother's Medicaid ID number.

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  • 11/13/17--04:50: Extended Care services
  • The term “extended care services” means the following items and services furnished to an inpatient of a skilled nursing facility (SNF) either directly or under arrangements as noted in the list below:

    • Nursing care provided by or under the supervision of a registered professional nurse;

    • Bed and board in connection with furnishing of such nursing care;

    • Physical or occupational therapy and/or speech-language pathology services furnished by the skilled nursing facility or by others under arrangements with them made by the facility;

    • Medical social services;

    • Such drugs, biologicals, supplies, appliances, and equipment, furnished for use in the skilled nursing facility, as are ordinarily furnished by such facility for the care and treatment of inpatients;

    • Medical services provided by an intern or resident-in-training of a hospital with which the facility has in effect a transfer agreement (see §50.7) under an approved teaching program of the hospital, and other diagnostic or therapeutic services provided by a hospital with which the facility has such an agreement in effect, and

    • Other services necessary to the health of the patients as are generally provided by skilled nursing facilities, or by others under arrangements.

    Skilled Nursing Facility Level of Care - General

    Care in a SNF is covered if all of the following four factors are met:

    • The patient requires skilled nursing services or skilled rehabilitation services, i.e., services that must be performed by or under the supervision of professional or technical personnel (see §§30.2 - 30.4); are ordered by a physician and the services are rendered for a condition for which the patient received inpatient hospital services or for a condition that arose while receiving care in a SNF for a condition for which he received inpatient hospital services;

    • The patient requires these skilled services on a daily basis (see §30.6); and

    • As a practical matter, considering economy and efficiency, the daily skilled services can be provided only on an inpatient basis in a SNF. (See §30.7.)

    • The services delivered are reasonable and necessary for the treatment of a patient’s illness or injury, i.e., are consistent with the nature and severity of the individual’s illness or injury, the individual’s particular medical needs, and accepted standards of medical practice. The services must also be reasonable in terms of duration and quantity.

    If any one of these four factors is not met, a stay in a SNF, even though it might include the delivery of some skilled services, is not covered. For example, payment for a SNF level of care could not be made if a patient needs an intermittent rather than daily skilled service.

    In reviewing claims for SNF services to determine whether the level of care requirements are met, the A/B MAC (A) first considers whether a patient needs skilled care. If a need for a skilled service does not exist, then the “daily” and “practical matter” requirements are not addressed. See section 30.2.2.1 for a discussion of the role of appropriate documentation in facilitating accurate coverage determinations for claims involving skilled care. Additional material on documentation appears in the various clinical scenarios that are presented throughout these level of care guidelines.

    Coverage of nursing care and/or therapy to perform a maintenance program does not turn on the presence or absence of an individual’s potential for improvement from the nursing care and/or therapy, but rather on the beneficiary’s need for skilled care. Eligibility for SNF Medicare A coverage has not changed with the inception of PPS. However, the skilled criteria and the medical review process have changed slightly. For Medicare to render payment for skilled services provided to a beneficiary during a SNF Part A stay, the facility must complete an MDS.

    EXAMPLE: Even though the irrigation of a suprapubic catheter may be a skilled nursing service, daily irrigation may not be “reasonable and necessary” for the treatment of a patient’s illness or injury.

    A certification or recertification statement must be signed by the attending physician or a physician on the staff of the skilled nursing facility who has knowledge of the case, or by a physician extender (that is, a nurse practitioner (NP), a clinical nurse specialist (CNS) or, effective with items and services furnished on or after January 1, 2011, a physician assistant (PA)) who does not have a direct or indirect employment relationship with the facility, but who is working in collaboration with the physician.

    In this context, the definition of a “direct employment relationship” is set forth in the regulations at 20 CFR 404.1005, 404.1007, and 404.1009. Under the regulations at 42 CFR 424.20(e)(2)(ii), when a physician extender has a direct employment relationship with an entity other than the facility, and the employing entity has an agreement with the facility that includes the provision of general nursing services under the regulations at 42 CFR 409.21, an “indirect employment relationship” exists between the physician extender and the facility. By contrast, such an indirect employment relationship does not exist if the agreement between the facility and the physician extender’s employer solely involves the performance of delegated physician tasks under the regulations at 42 CFR 483.40(e).

    Patients covered under hospital insurance are entitled to have payment made on their behalf for covered extended care services. Payment may be based on reasonable cost or be under the SNF Prospective Payment System (see §10). The facility may charge the beneficiary for services they request that are not included in the PPS rate or otherwise covered by Medicare (i.e. extra meals for family members).

    An inpatient is a person who has been admitted to a skilled nursing facility or swing bedhospital for bed occupancy for purposes of receiving inpatient services. A person is considered an inpatient if formally admitted as an inpatient with the expectation that they will remain at least overnight and occupy a bed even though it later develops that they can be discharged and do not actually use a bed overnight.

    Physical Therapy, Speech-Language Pathology, and Occupational

    Therapy Furnished by the Skilled Nursing Facility or by Others Under Arrangements With the Facility and Under Its Supervision

    For Speech-Language Pathology, see Medicare Benefit Policy Manual, Chapter 1, “Inpatient Hospital Services,” §100. For Occupational Therapy, see Medicare Benefit Policy Manual, Chapter 1,"Inpatient Hospital Services,” §90.

    Note these services must be provided by the SNF or by others under arrangements with the SNF for beneficiaries in either a covered Part A stay or a non-covered stay in the SNF. Bundling to the SNF is not required for beneficiaries residing in a non-certified portion of a facility containing a distinct part SNF if the facility as whole is not primarily engaged in the provision of skilled care

    Drugs and Biologicals

    Drugs and biologicals for use in the facility, which are ordinarily furnished by the facility for the care and treatment of inpatients, are covered. Such drugs and biologicals are not limited to those routinely stocked by the skilled nursing facility but include those obtained for the patient from an outside source, such as a pharmacy in the community. Drugs and biologicals are included in the SNF PPS except for those Part B drugs specifically excluded. Since the provision of drugs and biologicals is considered an essential part of skilled nursing care, a facility must assure their availability to inpatients

    in order to be found capable of furnishing the level of care required for participation in the program. When a facility secures drugs and biologicals from an outside source, their availability is assured only if the facility assumes financial responsibility for the necessary drugs and biologicals, i.e., the supplier looks to the facility, not the patient, for payment.

    The use of an operating room and any special equipment, supplies, or services would not constitute covered extended care services except when furnished to the facility by a hospital with which the facility has a transfer agreement, since operating rooms are not generally maintained by skilled nursing facilities. However, supplies and nursing services connected with minor surgery performed in a skilled nursing facility that does not require the use of an operating room or any special equipment or supplies associated with such a room would be covered extended care services and paid as part of inpatient SNF PPS.

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    Procedure code and Description

    36251 Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral

    36252 Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; bilateral

    36253 Superselective catheter placement (one or more second order or higher renal artery branches) renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture, catheterization, fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral

    36254 Superselective catheter placement (one or more second order or higher renal artery branches) renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture, catheterization, fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; bilateral.


    Catheter-based renal angiography, the longstanding “gold standard” for the diagnosis of renal artery stenosis  (RAS), has been largely replaced as a practical first-line modality by noninvasive imaging studies (e.g., duplex ultrasonography, magnetic resonance angiography (MRA), computed tomographic angiography (CTA)). Renal angiography services will be denied without a prior non-invasive renal artery study that is inconclusive or unavailable. Exceptions to this rule may occur in patients with fibromuscular dysplasia or renal artery aneurysms where there may be branch involvement.

    Routine non-selective renal angiography, pejoratively called “drive-by angiography,” performed at the time of cardiac catheterization in the absence of accepted clinical indications that support medical necessity, as mentioned in this LCD, will be denied as such services are generally not indicated. In addition, the treating physician must specifically request this extra-cardiac angiographic service. A provider should not report CPT codes 36251, 36252, 36253 and 36254 (renal angiography, selective) unless the renal artery(s) is (are) catheterized and a complete renal angiogram, including the venous phase, is performed and interpreted.

    There are no absolute contraindications to diagnostic aortography/angiography. Relative contraindications include but are not limited to:

    A. Severe hypertension
    B. Uncorrectable coagulopathy or thrombocytopenia
    C. Clinically significant sensitivity to iodinated contrast material
    D. Renal insufficiency based on the estimated glomerular filtration rate (eGFR)
    E. Congestive heart failure
    F. Certain connective tissue disorders which may indicate increased risk for complications at the puncture site

    Diagnostic angiography performed at a separate session from an interventional procedure may be separately reportable. If a diagnostic angiogram was performed prior to an interventional procedure, a second diagnostic angiogram performed at the time of an interventional procedure is separately reportable when documentation supports it is medically reasonable and necessary to repeat the study to further define the anatomy and pathology. If the prior diagnostic angiogram was performed, a second angiogram (e.g., for the contrast injections necessary to perform the interventional procedure) is not separately reportable.

    The localization or guidance is integral to an interventional procedure and is not separately reportable unless CPT instructions specify otherwise.

    In addition to the initial procedure, an appropriate frequency of repeat procedures can be allowed as long as medical necessity is clearly established and documented. It is expected that important diagnostic information will be obtained from the angiography, which will assist in patient management and treatment. Repeat angiography may be medically reasonable and necessary if there is documentation of new and incapacitating symptoms. CMS issued HCPCS code G0278 for femoral or iliac angiography when done at the time of coronary angiography. Medicare would not expect to see a high percentage of femoral or iliac angiography done at the same time of coronary studies, and such billing could be subject to review. Renal angiography performed at the time of cardiac catheterization in the absence of accepted clinical indication that support medical necessity will be denied as such services are generally not indicated, as mentioned in this LCD.

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    ENTERAL NUTRITION

    Enteral nutrition is nutrition administered by tube or orally into the gastrointestinal tract. Enteral nutrition is classified into categories that possess similar characteristics. Categories for enteral nutrition are listed by HCPCS codes on the MDHHS Medical Supplier/DME/Prosthetics and Orthotics Fee Schedule on the MDHHS website. For the appropriate HCPCS code, products are listed on the enteral nutrition product classification list on the website for the Medicare Pricing, Data Analysis and Coding (PDAC) contractor. If the formula is not listed in the covered HCPCS codes, the provider must contact the PDAC contractor for a coding determination. (Refer to the Directory Appendix for website and contact information.)



    ENTERAL NUTRITION (ADMINISTERED ORALLY)

    Standards of Coverage

    Enteral nutrition (administered orally) may be covered for beneficiaries under the age of 21 when:

    * A chronic medical condition exists resulting in nutritional deficiencies, and a threemonth trial is required to prevent gastric tube placement; or

    * Supplementation to regular diet or meal replacement is required, and the beneficiary's weight-to-height ratio has fallen below the fifth percentile on standard growth grids; or

    * Physician documentation details low percentage increase in growth pattern or trend directly related to the nutritional intake and associated diagnosis/medical condition.

    For CSHCS coverage, a nutritionist or appropriate pediatric subspecialist must indicate that long-term enteral supplementation is required to eliminate serious impact on growth and development.

    For Healthcare Common Procedure Coding System (HCPCS) code B4162, the beneficiary must have a specified inherited disease of metabolism identified by the International Classification of Diseases (ICD).


    For beneficiaries age 21 and over:

    * The beneficiary must have a medical condition that requires the unique composition of the formula nutrients that the beneficiary is unable to obtain from food; or

    * The nutritional composition of the formula represents an integral part of treatment of the specified diagnosis/medical condition; or

    * The beneficiary has experienced significant weight loss. For Healthcare Common Procedure Coding System (HCPCS) code B4157, the beneficiary must have a specified inherited disease of metabolism identified by the International Classification of Diseases (ICD).

    Documentation Documentation must be less than 30 days old and include:

    * Specific diagnosis/medical condition related to the beneficiary's inability to take or eat food.

    * Duration of need.

    * Amount of calories needed per day.

    * Current height and weight, as well as change over time. (For beneficiaries under 21, weight-to-height ratio.)

    * Specific prescription identifying levels of individual nutrient(s) that is required in increased or restricted amounts.

    * List of economic alternatives that have been tried.

    For continued use beyond 3-6 months, the CSHCS Program requires a report from a nutritionist or appropriate pediatric subspecialist.


    PA Requirements PA is required for all enteral formula for oral administration.

    The following HCPCS codes require authorization via a telephone authorization process:

    B4034 B4035 B4036 B4081 B4082 B4083 B4087 B4088 B4102 B4149 B4150 B4152 B4153 B4154 B4155 B4157 B4158 B4159 B4160 B4161 B4162 B9000 B9002 B9998

    Refer to the Directory Appendix for Telephone Prior Authorization Contractor information.


    ENTERAL NUTRITION (ADMINISTERED BY TUBE)

    Standards of Coverage

    Enteral formula are covered when the diagnosis/medical condition requires placement of a gastric tube and nutrition is administered by syringe, gravity, or pump.

    Documentation Documentation must be less than 30 days old and include:

    * Specific diagnosis/medical condition requiring tube feeding.

    * Duration of treatment.

    * Amount needed per day.

    * If a pump is required, the medical reason why syringe or gravity method could not be used.

    PA Requirements PA is not required for standard formula for enteral tube feedings provided up to the program's established quantity limits per month. (Applies only to specific enteral formula and related supplies and equipment. Refer to the Medicaid Code and Rate Reference tool for additional information.)

    PA is required for the following:

    * All specialized enteral formula requests for tube feedings.

    * Over-quantity requests for standard formula enteral tube feedings.

    * Medical need beyond Standards of Coverage.

    The following HCPCS codes require authorization via a telephone authorization process:

    B4034 B4035 B4036 B4081 B4082 B4083 B4087 B4088 B4102 B4149 B4150 B4152 B4153 B4154 B4155 B4157 B4158 B4159 B4160 B4161 B4162 B9000 B9002 B9998

    Refer to the Directory Appendix for Telephone Prior Authorization Contractor information.



    ENTERAL NUTRITION PAYMENT RULES

    When billing for enteral formula (administered orally or by tube), the appropriate formula HCPCS code should be billed on a monthly basis with total calories used (divided by 100) as the unit amount. (To calculate the appropriate number of caloric units, combine total calories of all cans to be used and divide by 100.) Medicaid will reimburse for a maximum quantity of up to 900 units for any combination of approved formula.

    Providers should refer to the following chart for additional assistance:

    Formula 100 calories = 1 unit (u) 6 (8 oz) cans a day

    1 month = 30 days

    6 months = 180 days

    5.00 cost/8 oz liquid or packet or can Standard @ 250 calories/8 oz 250 cals/100 =2.5 units 2.5 u x 6 = 15 units a day
    15 u x 30 = 450 units a month 15 u x 180=2700 units for 6 months $5.00 ÷ 2.5 u = $2.00 per unit Caloric Dense @ 355
    calories/8 oz 355 cals/100 =3.55 units 3.55 u x 6= 21 units a day 21 u x 30 = 630 units a month 21 u x 180 =
    3780 units for 6 months $5.00 ÷ 3.55 u = $1.41 per unit Powder, 1 package = 150 calories 150 cals/ 100
    = 1.5 units 1.5 u x 6 = 9  nits a day 9 u x 30 = 270 units a month 9 u x 180 =1620 units for 6 months $5.00 ÷ 1.5 u =
    $3.33 per unit Powder, 1# can = 112 oz when mixed @ 20 calories/oz* = 2240 calories for the entire can

    (*can vary with physician orders) 2240 cals/100 = 22.4 units 6 cans per month = 22.4 u x 6 = 134 units a month 134 u x 6 months = 804 units for 6 months $5.00 ÷ 22.4 u = $0.30 per unit

    The necessary equipment and supply code for enteral tube feedings should be billed up to specified quantity limits. Feeding bags, anchoring devices, syringes, drain sponges, cotton tip applicators, tape, adaptors, and connectors used in conjunction with a gastrostomy or enterostomy tube are included in the supply kit codes and should not be billed separately.

    Dietary formula for oral feedings may be obtained from either a medical supplier or a pharmacy.

    Dietary formula for tube feedings are covered only through the medical supplier.


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    SERVICES PROVIDED BY NON-PHYSICIANS AND RESIDENT PHYSICIANS

    A. All non-physicians, who are defined as eligible providers under the member’s BCBSKS contract and who are providing services as defined in their Kansas licensure or certification, shall bill their charges to BCBSKS under their own National Provider Identifier (NPI) or specific performing provider number, if applicable. The name of the ordering provider, when applicable, (including NPI, except when exempt by law) must appear on every claim.

    B. A physician may bill for the services of a licensed nurse, other than an APRN, if there is an employer/employee relationship and the services are supervised by the physician (supervision means the patient recognizes the supervising physician as his/her physician and there is a periodic review of the records by the physician). These services must be an integral part of the physician's professional service, included in the physician's bill, and be of the type that are commonly furnished in the physician's office or clinic.

    C. Independently practicing Advanced Practice Registered Nurses (APRNs) who are providing services as defined in their Kansas licensure or certification, shall bill their charges to BCBSKS under their own NPI or specific performing provider number. The name of the ordering provider, when applicable, (including NPI, except when exempt by law) must appear on every claim.

    D. Services of a Resident Physician are billed under the attending Faculty Physician’s NPI or specific performing provider number if done in connection with the Residency Program.

    E. If the Resident Physician is providing services outside of the Residency Program, all Blue Shield Policy Memos apply and services shall be billed under his/her own NPI or specific performing provider number.

    F. BCBSKS will not pay for any services performed and billed by an independent provider who does not meet applicable state or national licensure registration or certification requirements to perform that service or who is not defined as an eligible provider in the member’s contract.

    G. BCBSKS will not pay for outpatient services connected with a nervous and mental diagnosis when provided by an unlicensed provider, or a licensed provider with a licensure other than designated in the member’s contract as eligible to provide nervous and mental benefits. Supervision of an unlicensed provider, a licensed counselor, or one not designated as eligible in the member’s contract does not constitute a service being rendered by an eligible provider. The exception to this would be if the service was rendered through a state licensed alcohol or drug abuse treatment facility, a hospital, psychiatric hospital, or a community mental health center. Eligible non-physician psychiatric providers include APRNs, certified psychologists, licensed specialist clinical social workers, licensed clinical marriage and family therapists, licensed clinical professional counselors, and licensed clinical psychotherapists.

    XIX. LOCUM TENENS PROVIDER

    In situations in which the regular provider is unavailable, a locum tenens can be used to provide a visit/service. The locum tenens must be the same type of provider as for whom the locum is substituting (for example, a physician can only authorize another physician as a locum tenens, an APRN/PA can only authorize another APRN/PA, etc.) and the locum tenens must be licensed in Kansas and only perform within his/her scope of license. The locum tenens must not provide services during a continuous period of longer than 60 days. For situations extending beyond 60 days, BCBSKS must be contacted to discuss billing arrangements.

    In billing for services provided by a locum tenens, the claim must be filed using the NPI or specific performing provider number of the provider for whom the locum tenens is substituting and a Q6 modifier must be used. In addition, the medical record must indicate the services were provided by a locum tenens.

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    VISIT PAYMENT POLICIES AND THE TRANSITION OF EPISODE CLAIMING:

    A “visit” is defined as a unit of service consisting of all the APG services preformed for a patient that are coded on the same claim and share a common date of service. There may be multiple APGs associated with a visit, depending on the services provided. Upon initial APG implementation (Dec. 2008), the “visit” was the basic unit for payment.

    As of July 1, 2009, for hospitals, most ancillary laboratory or radiology services associated with a medical visit and/or a significant procedure billed under the APG payment methodology became the fiscal responsibility of the APG provider and had to be included on the APG claim, even if the ancillary services were provided by outside vendors or on different dates of service. This ancillary policy will also apply to D&TCs prospectively effective January 1, 2011. Consistent with this change, new rate codes were issued for hospital OPDs and will be issued for DT&C clinics which enable the APG Grouper/Pricer to recognize an “episode” of care. An “episode” is defined as a unit of service consisting of all services on a claim, regardless of the coded dates of service. Under episode billing an episode shall consist of all medical visits and or procedures that are provided by a clinic to a patient on a single date of service plus any associated non-carved out ancillary laboratory or radiology services, regardless of the date of service of those ancillaries. Under episode claiming, multiple episodes should not be coded on the same claim or the payment could be subject to excessive packaging, consolidating, and/or discounting.

    For emergency departments, the significant procedures and/or medical visits comprising the non-carved out ancillary services portion of an episode need not be on a single date of service and may instead be on consecutive dates of service.

    USE OF VISIT AND EPISODE RATE CODES:

    The EAPG Grouper/Pricer is programmed to use two grouping mechanisms for billing purposes. The “visit” grouping mechanism applies APG packaging, consolidation, and discounting to all services on a claim with the same date of service. With visit billing there can be more than one visit on the claim and each visit will process separately through the grouper/pricer based on the coded dates of service. The “episode” grouping mechanism applies APG packaging, consolidation, and discounting to all services on a claim regardless of the date of service.

    Therefore, on an episode claim there can be only one visit/episode on the claim and date of service is ignored by the grouper/pricer.

    Visit Rate Codes and Ancillaries: When using visit rate codes to claim for a visit, all associated ancillary or radiology services must be reported on the same claim as the medical visit or significant procedure that generated the ancillary service. For claiming purposes, providers must reassign the dates of ancillary lab or radiology services to correspond with the date of the medical visit or significant procedure that generated the ancillary service. If the dates of the ancillaries are not reassigned, it is likely that they will be viewed by the grouper/pricer as “if stand alone, do not pay procedures” and no payment will be made. To avoid the reassignment of dates that can be necessary under visit claiming, NYS DOH implemented the episode claiming option, whereunder correct dates of service can be coded for the ancillaries and they will still group with, and be paid with, the relevant/associated medical visit or significant procedure. While multiple visits may be reported on the same claim when using visit rate codes, the Grouper/ Pricer will apply the APG grouping logic to all services and procedures with the same date of service.

    All services and procedures provided to a patient with the same date of service and rate code (based on servicing provider type – i.e. OPD, Ambulatory Surgery Center, ED, and D&TC) must be billed together on one claim. If two claims are submitted for the same patient with the same rate code, same date of service, and same provider (hospital or D&TC), only the first claim submitted will result in payment. The second claim will be denied. If a patient returns to the clinic for multiple visits on the same date of service, all the procedures must be billed on one claim with the appropriate APG rate code (1400 for hospital OPDs or 1407 for DTCs). If the provider attempts to submit multiple APG claims for that rate code for the same recipient/same date of service, only one claim will be paid.

    All others will be denied as duplicative claims. If a patient is initially seen in the hospital emergency room and the visit ultimately results in the provision of a same-day ambulatory surgery service outside of the emergency room, the hospital should bill the visit only under the ambulatory surgery rate code. Episode Rate Codes: As described above, for purposes of APG reimbursement an “episode of care consists of a medical visit and/or significant procedure that occurred on a single date of service and all the associated ancillary laboratory or radiology services that occurred on or after the date of the medical visit or significant procedure. When using an episode rate code to claim for an episode of care, providers must include a “from” and “to” date in the claim header to reflect the episode of care as well as specific dates at the line level for each service provided as part of the “episode of care.

    All procedure codes related to an episode of care should be reported on a single claim with their actual dates of service. This includes the medical visit and or procedures that occurred on a single date of service and all associated ancillary laboratory or radiology services on or after the medical visit or significant procedure, regardless of the provider or date of service. When using an episode rate code, the Grouper/Pricer will apply the APG grouping logic to all services and procedures on the claim, regardless of the dates of service. If procedures from two different episodes of care are coded on the same claim, unwarranted discounting or consolidation may occur, resulting in underpayment to the APG biller.

    As with use of the visit rate code, if two claims are submitted by the same APG provider for the same patient, using the same episode rate code and the same “from” date for the episode of care, only the first claim submitted will result in payment. The second claim will be denied.

    Note: Implementation of the ancillary billing policy described above will be delayed for DTCs until January 1, 2011.

    Therefore, upon implementation of APGs in DTCs through December 31, 2010, ancillary laboratory and radiology services which have historically been referred by DTCs to outside providers or vendors may continue to be billed directly to EMedNY by the ancillary service provider using the appropriate Medicaid fee schedule. During this time period, these ancillary services are not the financial responsibility of the DTC and should not be reported on the

    APG claim. However, any ancillary laboratory or radiology service provided directly by the DTC clinic or historically included in the clinic’s former threshold or specialty (e.g. as with former PCAP rate codes) payment should be reported on the APG claim, even those that map to “a never pay APG” or an “if stand alone do not pay APG.”. The ancillary billing policy will be implemented prospectively in DTCs, effective January 1, 2011. Additional guidance on the ancillary billing policy will be issued at that time. In the interim, see Section 4.4 for more information on the APG ancillary billing policy.


    APG billers assigned episode rate codes (hospital OPDs, D&TCs, and SBHCs) are expected to use episode rate codes for all claims effective January 1, 2011, except when billing for Medicare/Medicaid dual eligibles or for services routinely billed on a monthly basis. In the interim, APG billers may use either the appropriate visit based rate codes (1400, 1407,1435) or the appropriate new episode of care rate codes( 1432, 1422,1425). After January 1, 2011, visit based rated codes may only be used for claims for Medicare/Medicaid dually eligible patients or for services that are billed for a patient on a monthly basis. The SDOH strongly encourages providers to use episode rate codes as episode rate codes enable more accurate reporting with respect to the date of ancillary lab and radiology services and, when used properly, episode rate codes will always result in as much or more payment than use of a visit rate code for the same bundle of services.

    UNITS OF SERVICE:

    Generally, the APG reimbursement system does not recognize units of service. However, effective January 1, 2010, providers may bill multiple units of service for a limited group of procedures including physical andoccupational therapy. Additional units-based procedures include nutrition counseling (e.g., CPT 97802 medical nutrition, indiv., 15 min.), crisis management (e.g., CPT H2011 crisis intervention service, 15 min.), patient education including diabetes and asthma self management services rendered by CDEs & CAEs , and health/behavioral assessments (e.g., CPT 96150 assess health behavior, initial).

    Providers should not code multiple lines on a single claim with the same HCPCS code (except for dental procedures such as multiple teeth sealed, multiple fillings, etc. – see section 4.2) to signify the provision of multiple units of a single procedure/service. Rather, they should include the HCPCS code on one line along with the number of units of the service provided on that same line. For physician administered drugs and all other services billed in multiple units, providers should bill for each drug  or service on a single claim line and identify the units provided on that line. Drug APGs are set to pay for the average units billed for each APG. Generally drugs are grouped into APGs based on the costs of a typical dosage. When multiple immunizations are rendered on the same date of service, the APG claim should include multiple codes for the administration of vaccine. The first administration code will pay at 100%; subsequent codes will be discounted at 50%.

    For a complete list of units-based procedures and their respective unit maximums, please
    visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/units_based_procedures.pdf.

    3.7 EMERGENCY ROOM – EPISODE OF CARE
    :

    If a patient enters the Emergency Department (ED) before midnight and leaves after midnight, the Grouper/Pricer  will treat the ED visit as a single episode of care. A single claim should be filed for each ED visit (episode of care) and the actual dates of service for each procedure should be reported on the claim. All ED services should be billed using the ED rate code, 1402.

    3.9 UTILIZATION THRESHOLDS:

    The Utilization Threshold Program continues to apply to clinic services billed as visits or episodes of care under APGs. Under the Utilization Threshold Program, it is necessary for clinic providers to obtain an authorization from the Medicaid Eligibility Verification System (MEVS) to render services to Medicaid patients. This authorization to render services will be given unless a recipient has reached his/her utilization threshold limit. If the individual’s threshold has been reached, the clinic physician must submit a “Threshold Override Application” (TOA) in order to obtain approval for the additional services.

    The Utilization Threshold Program has been revised to provide individual thresholds, which are refreshed quarterly, for every Medicaid recipient based on their health risk status. These new thresholds will be implemented in 2009. Notification of these changes will be forthcoming in a Medicaid Update article. As of March 1, 2010, revised TOA forms must be used. These forms may be obtained by calling the eMedNY call center at (800) 343-9000. The Utilization Threshold Guide is available online at: www.emedny.org/HIPAA/provider_training/training.html.

    3.10 REMITTANCE:

    The 835 remittance will include line level detail including the APG code, APG full weight, APG allowed percentage, APG paid amount, the payment based on existing operating reimbursement (the blend amount), “combined with CPT” (if reimbursement for a particular CPT/APG has been consolidated or packaged within another CPT/APG, this field indicates the CPT/APG to which payment has been consolidated/packaged), capital add-on amount, and the total payment for the claim. The 835 Companion Guide, which provides detail for all the APG remittance changes, is now available on the www.eMedNY.org website under NYHIPAADESK.

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    Code Description CPT

    82310 Calcium; total
    82725 Fatty acids, nonesterified
    84590 Vitamin A
    84591 Vitamin, not otherwise specified
    84999 Unlisted chemistry procedure
    86353 Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis
    88348 Electron microscopy, diagnostic


    Introduction
    Micronutrients are essential vitamins and minerals. Getting enough of them is important for good health. It’s rare in the United States to have medical conditions caused by lack of nutrients like vitamins A, B1, B12, C, and D, and selenium. Most people get enough vitamins and minerals through their diet or over-the-counter vitamins. Blood samples are a proven way to measure the level of essential nutrients. Other tests have been created that look at nutrient levels inside cells.

    These tests are unproven. There are no published medical studies showing whether the cell tests are more accurate or useful than standard blood tests at measuring levels of vitamins or minerals. There are also no randomized controlled trials — studies that randomly put people in different study groups — exploring whether the cell tests are effective to screen for or diagnose nutrient deficiencies.

    Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.



    When reviewing intracellular micronutrient panel testing, the entire panel is to be reviewed as a whole versus the individual elements of the panel.

    Reference Laboratories (see Benefit Application)
    IntraCellular Diagnostics
    IntraCellular Diagnostics uses electron microscopy for which CPT code 88348 might be reported.

    SpectraCell Laboratories

    According to SpectraCell Laboratories, their total antioxidant function testing (SPECTROX®) is reported using CPT code 86353.

    Benefit Application

    This testing is currently only available through two reference laboratories: SpectraCell Laboratories (Houston, TX) and IntraCellular Diagnostics (Medford, OR).

    Evidence Review Description

    Commercial laboratories offer panels of tests evaluating intracellular levels of micronutrients (essential vitamins and minerals). Potential uses of these tests include screening for nutritional deficiencies in healthy people or those with chronic disease and aiding in the diagnosis of disease in patients with nonspecific symptoms.
    Background

    Vitamin Deficiencies

    “Micronutrients” collectively refer to essential vitamins minerals necessary in trace amounts for health. Clinical deficiency states (states occurring after prolonged consumption of a diet lacking the nutrient and is treated by adding the nutrient to the diet) have been reported for vitamins A, B1, B12, C, and D, selenium, and other micronutrients. Classic nutritional deficiency diseases are uncommon in the United States; most people derive sufficient nutrition from their diets alone or in combination with over-the-counter multivitamins. Laboratory tests are available for individual micronutrients and are generally used to confirm suspected micronutrient deficiencies. Testing is performed by serum analysis using standardized

    values for defining normal and deficient states. In addition, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.

    Diagnostic Testing

    This policy evaluates novel laboratory tests that measure the intracellular levels of micronutrients. This testing, also known as intracellular micronutrient analysis, micronutrient testing or functional intracellular analysis is claimed to be superior to serum testing because intracellular levels reflect more stable micronutrient levels over longer time periods than serum levels and because intracellular levels are not influenced by recent nutrition intake. However, the relation between serum and intracellular levels of micronutrients is complex. The balance of intra- and extracellular levels depends on a number of factors, including the physiology of cellular transport mechanisms and the individual cell type.

    At least 2 commercial laboratories offer intracellular testing for micronutrients. Laboratories perform a panel of tests evaluating the intracellular level of a variety of micronutrients (eg, minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics evaluates epithelial cells from buccal swabs and assesses levels of intracellular mineral electrolyte (ie, magnesium, calcium, potassium, phosphorous, sodium, chloride). SpectraCell Laboratories offers a panel of tests that evaluates the intracellular status of micronutrients within lymphocytes in blood samples. The micronutrients measured by the test include:

    * Vitamins: A, B1, B2, B3, B6, B12, C, D, K; biotin, folate, pantothenic acid
    * Minerals: calcium, magnesium, zinc, copper
    * Antioxidants: alpha lipoic acid, coenzyme Q10, cysteine, glutathione, selenium, vitamin E
    * Amino acids: asparagine, glutamine, serine
    * Carbohydrate metabolism: chromium, fructose sensitivity, glucose-insulin metabolism
    * Fatty acids: oleic acid
    * Metabolites: choline, inositol, carnitine

    The SpectraCell micronutrient panel also includes an evaluation of total antioxidant function.

    Summary of Evidence

    For individuals who have chronic diseases or nonspecific generalized symptoms who receive intracellular micronutrient analysis, the evidence includes observational studies. Relevant  outcomes are test accuracy, symptoms, and change in disease status. No studies were identified that evaluated clinical validity or clinical utility of intracellular micronutrient testing compared with standard testing for vitamin or mineral levels. Limited data from observational studies are available on correlations between serum and intracellular micronutrient levels. No randomized controlled trials or other comparative studies were identified evaluating the direct health impact of intracellular micronutrient testing. Moreover, there are insufficient data to construct a chain of evidence that intracellular micronutrient testing would likely lead to identifying patients whose health outcomes would be improved compared with alternative approaches to patient management. The evidence is insufficient to determine the effects of the technology on health outcomes.

    Ongoing snd Unpublished Clinical Trials

    A search of ClinicalTrials.gov in January 2018 did not identify any ongoing or unpublished trials that would likely influence this review. Practice Guidelines and Position Statements No guidelines or statements were identified.

    Medicare National Coverage

    There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.


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    Coding Code Description CPT

    33361 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

    33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

    33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach

    33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

    33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy)

    33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy)

    33367 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure)

    33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure)

    33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure)


    Transcatheter Aortic Valve Implantation for Aortic Stenosis

    Introduction


    The aortic valve is a valve that separates the main pumping chamber of the heart (the left ventricle) from the large artery that takes oxygen rich blood away from the heart and out to the body (the aorta). If the valve doesn’t completely open, it is called aortic stenosis. Aortic stenosis decreases the amount of oxygenated blood getting out to the body. Open surgery is one method of replacing a damaged aortic valve. A newer procedure — known as transcatheter aortic valve replacement or transcatheter aortic valve implantation — has been developed. It allows a replacement valve to be threaded through an artery and into the heart without open heart surgery. A catheter (a long thin, tube) is threaded through an artery, either in the leg or in the chest, and into the heart. The replacement valve is then lodged into the defective aortic valve. The new valve is then expanded, pushing aside parts of the old valve. This policy describes when transcatheter aortic valve replacement may be considered medically necessary. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


    Procedure Medical Necessity Transcatheter aortic valve replacement

    Transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)*approved transcatheter heart valve system, when performed via an approach consistent with the device’s FDA-approved labeling, may be considered medically necessary as a treatment for native valve aortic stenosis when ALL of the following criteria are met:
    * Severe aortic stenosis (see the Definition of Terms section) with a calcified aortic annulus is present AND
    * New York Heart Association (NYHA) heart failure class II, III or IV symptoms AND
    * Left ventricular ejection fraction greater than 20% AND
    * Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high or intermediate risk for open surgery (see the

    Definition of Terms section)

    Transcatheter aortic valve replacement with an FDA approved transcatheter heart valve system for repair of a degenerated bioprosthetic valve may be considered medically necessary

    when ALL of the following criteria are met:
    * Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve AND
    * NYHA heart failure class II, III or IV symptoms AND
    * Left ventricular ejection fraction greater than 20% AND
    * Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high risk for open surgery (see the Definition of


    Medical Necessity Terms section)

    Transcatheter aortic valve replacement is considered investigational for all other indications and when criteria are not met.





    Related Information Definition of Terms

    Extreme risk or inoperable for open heart surgery: FDA definition of extreme risk or inoperable for open surgery:

    * Predicted risk of operative mortality and/or serious irreversible morbidity 50% or higher for open surgery High Risk for open heart surgery: FDA definition of high risk for open surgery:
    * Society of Thoracic Surgeons predicted operative risk score of 8% or higher; or
    * Judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery Intermediate risk: FDA definition of intermediate risk is:
    * Society of Thoracic Surgeons predicted operative risk score of 3% to 7%. Severe aortic stenosis: For the use of the Sapien or CoreValve devices, severe aortic stenosis is defined by the presence of one or more of the following criteria:
    * An aortic valve area of less than or equal to 1 cm2
    * An aortic valve area index of less than or equal to 0.6 cm2/m2
    * A mean aortic valve gradient greater than or equal to 40 mm Hg
    * A peak aortic-jet velocity greater than or equal to 4.0 m/s

    Description

    Transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement) is a potential treatment for patients with severe aortic stenosis. Many patients with aortic stenosis are elderly and/or have multiple medical comorbidities, thus indicating a high, often prohibitive, risk for surgery. This procedure is being evaluated as an alternative to open surgery, or surgical aortic valve replacement (SAVR), for high-risk patients with aortic stenosis and as an alternative to nonsurgical therapy for patients with a prohibitive risk for surgery.

    Background

    Aortic Stenosis


    Aortic stenosis is defined as narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Progressive calcification of the aortic valve is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries.1 Congenital abnormalities of the aortic valve, most commonly a bicuspid valve, increase the risk for aortic stenosis, but aortic stenosis can also occur in a normal aortic valve. Risk factors for calcification of a congenitally normal valve mirror those for atherosclerotic vascular disease, including advanced age, male gender, smoking, hypertension, and hyperlipidemia.1 Thus, the pathogenesis of calcific aortic stenosis is thought to be similar to that of atherosclerosis, ie, deposition of atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification.

    The natural history of aortic stenosis involves a long asymptomatic period, with slowly progressive narrowing of the valve until the stenosis reaches the severe stage. At this time, symptoms of dyspnea, chest pain, and/or dizziness and syncope often occur and the disorder  progresses rapidly. Treatment of aortic stenosis is primarily surgical, involving replacement of the diseased valve with a bio-prosthetic or mechanical valve by open heart surgery.

    Disease Burden Aortic stenosis is a relatively common disorder in elderly patients and is the most common acquired valve disorder in the UnitedStates. Approximately 2% to 4% of people older than 65 years of age have evidence of significant aortic stenosis,1 increasing up to 8% of people by age 85 years.2 In the Helsinki Aging Study (1993), a population-based study of 501 patients ages 75 to 86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%.3 In the United States, more than 50,000 aortic valve replacements are performed annually due to severe aortic stenosis.

    Aortic stenosis does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it becomes severe, there is an untreated mortality rate of approximately 50% within 2 years.4 Open surgical repair is an effective treatment for reversing aortic stenosis, and artificial valves have demonstrated good durability for periods of up to 20 years.4 However, these benefits are accompanied by a perioperative mortality of approximately 3% to 4% and substantial morbidity,4 both of which increase with advancing age.

    Unmet Needs
    Many patients with severe, symptomatic aortic stenosis are poor operative candidates. Approximately 30% of patients presenting with severe aortic stenosis do not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities.5 For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes.6 Balloon valvuloplasty can improve symptoms and increase flow across the stenotic valve but is associated with high rates of complications such as stroke, myocardial infarction (MI), and aortic regurgitation. Also, restenosis can occur rapidly, and there is no improvement in mortality. As a result, there is a large unmet need for less invasive treatments for aortic stenosis in patients who are at increased risk for open surgery.

    Treatment

    Transcatheter aortic valve implantation (TAVI) has been developed in response to this unmet needand was originally intended as an alternative for patients for whom surgery was not an option due toprohibitive surgical risk or for patients at high risk for open surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also  be done through the subclavian artery approach and transapically using mediastinoscopy. Balloon valvuloplasty is first performed to open up the stenotic area. This is followed by passageof a bioprosthetic artificial valve across the native aortic valve. The valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic valve annulus. The procedure is performed on the beating heart without the need for cardiopulmonary bypass.

    Summary of Evidence
    For individuals who have severe symptomatic aortic stenosis who are at prohibitive risk for open surgery who receive transcatheter aortic valve implantation (TAVI), the evidence includes a randomized controlled trial (RCT) comparing TAVI with medical management in individuals at prohibitive risk of surgery, a single-arm prospective trial, multiple case series, and multiple systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are not surgical candidates due to excessive surgical risk, the PARTNER B trial reported on results for patients treated with TAVI by the transfemoral approach compared with continued medical care with or without balloon valvuloplasty. There was a large decrease in mortality for the TAVI patients at 1 year compared with medical care. This trial also reported improvements in other relevant clinical outcomes for the TAVI group. There was an increased risk of stroke and vascular complications in the TAVI group. Despite these concerns, the overall balance of benefits and risks from this trial indicate that health outcomes are improved. For patients who are not surgical candidates, no randomized trials have compared the self-expandable valve with best medical therapy. However, results from the single-arm CoreValve Extreme Risk Pivotal Trial met trialists’ pre-specified objective performance goal. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

    For individuals who have severe symptomatic aortic stenosis who are at high risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals at high risk for surgery, multiple nonrandomized comparative studies, and systematic reviews of these studies. Relevant outcomes are overall survival, symptoms, morbid events, and  treatment-related mortality and morbidity.


    For patients who are high risk for open surgery and are surgical candidates, the PARTNER A trial reported noninferiority for survival at 1 year for the balloon-expandable valve compared with open surgery. In this trial, TAVI patients also had higher risks for stroke and vascular complications. Nonrandomized comparative studies of TAVI versus open surgery in high-risk patients have reported no major differences in rates of mortality or stroke between the 2 procedures. Since publication of the PARTNER A trial, the CoreValve High Risk Trial demonstrated noninferiority for survival at 1 year and 2 years for the self-expanding prosthesis. This trial reported no significant differences in stroke rates between groups. In an RCT directly comparing the self-expandable with the balloon-expandable valve among surgically high-risk patients, the devices had similar 30-day mortality outcomes, although the self-expandable valve was associated with higher rates of residual aortic regurgitation and requirement for a new permanent pacemaker. Evidence from RCT and nonrandomized studies has suggested that TAVI with a self-expanding device is associated wit higher rates for permanent pacemakers postprocedure. However, survival rates appear to be similar between device types, and the evidence does not clearly support the superiority of one device over another in all patients. Two sex-specific studies were also identified in a literature search with the objective of observing mortality rates in women undergoing TAVI or SAVR. Results were varied, and further study is needed. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

    For individuals who have severe symptomatic aortic stenosis who are at intermediate risk for open surgery who receive TAVI, the evidence includes 3 RCTs comparing TAVI with surgical repair including individuals at intermediate surgical risk, 2 RCTs only in patients with intermediate risk, and multiple systematic reviews and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Five RCTs have evaluated TAVI in patients with intermediate risk for open surgery. Three of them, which included over 4000 patients combined, reported noninferiority of TAVI vs SAVR for their composite outcome measures (generally including death and stroke). A subset analysis of patients (n=383) with low and intermediate surgical risk from a fourth trial reported higher rates of death at 2 years for TAVI vs SAVR. The final study (N=70) had an unclear hypothesis and reported 30-day mortality rates favoring SAVR (15% vs 2%, p=0.07) but used a transthoracic approach. The rates of adverse events differed between groups, with bleeding, cardiogenic shock, and acute kidney injury higher in patients randomized to open surgery and permanent pacemaker requirement higher in patients randomized to TAVI. Subgroup analyses of meta-analyses and the transthoracic arm of the Leon et al RCT has suggested that the benefit  of TAVI may be limited to patients who are candidates for transfemoral access. Although several RCTs have 2 years of follow-up postprocedure, it is uncertain how many individuals require reoperation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

    For individuals who have severe symptomatic aortic stenosis who are at low risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals selected without specific surgical risk criteria but including patients at low surgical risk, systematic reviews, and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Limited data are available comparing SAVR with TAVI in patients who had severe aortic stenosis with low risk for open surgery. A systematic review including the low surgical risk patients of these 2 RCTs, and 4 observational studies, with propensity score matching, reported that the 30-day and inhospital mortality rates were similar for TAVI (2.2%) and SAVR (2.6%). However, TAVI was associated with increased risk of mortality with longer follow-up (median, 2 years; 17.2% vs 12.7%). TAVI was associated with reduced risk for bleeding, renal failure and, an increase in vascular complications and pacemaker implantation compared with SAVR. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have valve dysfunction and aortic stenosis or regurgitation after aortic valve repair who receive transcatheter aortic “valve-in-valve” implantation, the evidence includes case series (largest included 459 patients) and systematic reviews of case series. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. These case series have reported high rates of technical success of valve implantation and improvement in heart-failure symptoms for most patients. However, they have also reported high rates of shortterm complications and high rates of mortality at 1 year postprocedure. There is a lack of evidence comparing valve-in-valve replacement with alternative treatment approaches. The evidence is insufficient to determine the effects of the technology on health outcomes.

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