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

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.

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

 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.

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.

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.

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.

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.

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.

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.

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.

Coding Code Description CPT

0075T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel

0076T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure)


Endovascular Therapies for Extracranial Vertebral Artery Disease


Introduction

The vertebral arteries travel along the spine, up the back of the neck, and enter the brain. When one of these arteries is narrowed, blocked, or there is a bulge before it enters the brain, it’s known as extracranial vertebral artery disease. (Extracranial means outside the skull.) Treatment usually involves medication or surgery. Other techniques that are done inside the blood vessels are being studied. These techniques are known as endovascular therapies. An example of an endovascular therapy is placing a tiny tube inside a blocked artery to allow blood to flow through it. Endovascular therapy for extracranial vertebral artery disease is investigational. These techniques are still being studied to see if they are as effective as standard treatments.

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. Policy Coverage Criteria

Service Investigational

Endovascular therapy Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery disease.

Note: The extracranial vertebral artery is considered to be segments V1-V3 of the vertebral artery from its origin at the subclavian artery until it crosses the dura mater.



Related Information N/A

Evidence Review

Description
Vertebral artery diseases, including atherosclerotic stenosis, dissections, and aneurysms, can lead to ischemia of the posterior cerebral circulation. Conventional management of extracranial vertebral artery diseases may include medical therapy (eg, antiplatelet or anticoagulant medications), medications to reduce atherosclerotic disease risk (eg, statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.

Background

Vertebrobasilar Circulation Ischemia

Ischemia of the vertebrobasilar or posterior circulation accounts for about 20% of all strokes. Posterior circulation strokes may arise from occlusion of the innominate and subclavian arteries, the extracranial vertebral arteries, or the intracranial vertebral, basilar, or posterior cerebral arteries. Compared with carotid artery disease, relatively little is known about the true prevalence of specific causes of posterior circulation strokes, particularly the prevalence of vertebral artery disease. A report from a stroke registry, Gulli et al (2013), estimated that in 9% of cases posterior circulation strokes are due to stenosis of the proximal vertebral artery.1 Patients who experience strokes or transient ischemic attacks of the vertebrobasilar circulation face a 25% to 35% risk of stroke within the subsequent 5 years. In particular, the presence of vertebral artery stenosis increases the 90-day risk of recurrent stroke by about 4-fold.

Relevant Clinical Anatomy and Pathophysiology

Large artery disease of the posterior circulation may be due to atherosclerosis (stenosis), embolism, dissection, or aneurysms. In about a third of cases, posterior circulation strokes are due to stenosis of the extracranial vertebral arteries or the intracranial vertebral, basilar, and posterior cerebral arteries. The proximal portion of the vertebral artery in the neck is the most common location of atherosclerotic stenosis in the posterior circulation. Dissection of the extracranial or intracranial vertebral arteries may also cause posterior circulation ischemia. By contrast, posterior cerebral artery ischemic events are more likely to be secondary to embolism from more proximal vessels.

The vertebral artery is divided into 4 segments, V1-V4, of which segments V1-V3 are extracranial. V1 originates at the subclavian artery and extends to the C5 or C6 vertebrae; V2


crosses the bony canal of the transverse foramina from C2 to C5; V3 starts as the artery exits the transverse foramina at C2 and ends as the vessel crosses the dura matter and becomes an intracranial vessel. The most proximal segment (V1) is the most common location for atherosclerotic occlusive disease to occur, while arterial dissections are most likely to involve the extracranial vertebral artery just before the vessel crosses the dura mater. Compared with the carotid circulation, the vertebral artery system is more likely to be associated with anatomic variants, including a unilateral artery.

Atherosclerotic disease of the vertebral artery is associated with conventional risk factors for cerebrovascular disease. However, risk factors and the underlying pathophysiology of vertebral artery dissection and aneurysms differ. Extracranial vertebral artery aneurysms and dissections are most often secondary to trauma, particularly those with excessive rotation, distraction, or flexion/extension, or iatrogenic injury, such as during cervical spine surgeries. Spontaneous vertebral artery dissections are rare, and in many cases are associated with connective tissue disorders including Ehlers-Danlos syndrome type IV, Marfan syndrome, autosomal-dominant polycystic kidney disease, and osteogenesis imperfecta type I.2

Management of Extracranial Vertebral Artery Disease
The optimal management of occlusive extracranial vertebral artery disease is not well defined. Medical treatment with antiplatelet or anticoagulant medications is a mainstay of therapy to reduce stroke risk. Medical therapy also typically involves risk reduction for classical cardiovascular risk factors. However, no randomized trials have compared specific antiplatelet or anticoagulant regimens.

Surgical revascularization may be used for vertebral artery atherosclerotic disease, but open surgical repair is considered technically challenging due to poor access to the vessel origin.

Surgical repair may involve vertebral endarterectomy, bypass grafting, or transposition of the vertebral artery, usually to the common or internal carotid artery. Moderately sized single-center case series of surgical vertebral artery repair from 2012 and 2013 have reported overall survival rates of 91% and 77% at 3 and 6 years postoperatively, respectively, and arterial patency rates of 80% after 1 year of follow-up.3,4 Surgical revascularization may be used when symptomatic vertebral artery stenosis is not responsive to medical therapy, particularly when bilateral vertebral artery stenosis is present or when unilateral stenosis is present in the presence of an occluded or hypoplastic contralateral vertebral artery. Surgical revascularization may also be considered in patients with concomitant symptomatic carotid and vertebral disease who do not have relief of vertebrobasilar ischemia after carotid revascularization.


The management of extracranial vertebral artery aneurysms or dissections is controversial due to uncertainty about the risk of thromboembolic events associated with aneurysms and dissections. Antiplatelet therapy is typically used; surgical repair, which may include vertebral bypass, external carotid autograft, and vertebral artery transposition to the internal carotid artery, or endovascular treatment with stent placement or coil embolization, may also be used. Given the technical difficulties related to surgically accessing the extracranial vertebral artery, endovascular therapies have been investigated for extracranial vertebral artery disease. Endovascular therapy may consist of percutaneous transluminal angioplasty, with or without stent implantation.

CPT code and Descriptions


 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty
43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption
43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)
43886 Gastric restrictive procedure, open; revision of subcutaneous port component only
43887 Gastric restrictive procedure, open; removal of subcutaneous port component only
43888 Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only


Bariatric Surgery

Introduction

Bariatrics is the branch of medicine dealing with the causes and treatment of obesity. Clinically severe obesity (also known as morbid obesity) is when a person is excessively overweight. Obesity itself is a health hazard as it impacts the heart, lungs, muscles, and bones of the body. In addition, obesity is a known risk factor to develop type 2 diabetes, heart disease and high blood pressure. Many individuals are able to lose weight by changing their diet and increasing their exercise. The challenge for most people is keeping off the weight they have lost. For some people surgery may be needed. Bariatric surgery is often referred to as weight loss surgery or obesity surgery. Surgical approaches to support long-term weight loss have been developed over the past 20 years. For some individuals the surgery works very well, although even after surgery people may need to significantly change their eating habits. Surgery is not without risk, however. There are several different types of weight loss surgery that are done on the stomach, intestine or both. They generally fall into two main categories: surgeries that restrict the amount of food that may be eaten, and surgeries that restrict the body’s ability to absorb calories and nutrients. Not all plans cover obesity surgery. When plans have a benefit for obesity surgery, then this policy describes what information is needed by the health plan to determine if the surgery may be covered.


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 fo 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. Policy Coverage Criteria Indication Coverage Criteria  Contract limitations Some health plan contracts do not have benefits to cover surgical treatment of morbid obesity, complications, or after effects associated with weight loss surgery. Refer to member contract language for benefit determination on weight loss surgery.

Patient selection criteria for adults (Must meet all 3 criteria) Bariatric (weight loss) surgery in an adult may be considered medically necessary when ALL of the following criteria are met:

* A body mass index (BMI) greater than 40 kg/m2 OR
* A BMI greater than 35 kg/m2 with at least ONE of the following conditions:
o Established Coronary Heart Disease, such as:
* History of angina pectoris (stable or unstable)
* History of angioplasty
* History of coronary artery surgery
* History of myocardial infarction
o Other Atherosclerotic Disease, such as:
* Abdominal aortic aneurysm
* Hypertension that is uncontrolled or resistant to treatment (medically refractory) with a blood pressure (BP) greater than 140/90 despite optimal medical management. Attempted medical management must have included at least 2 medications of different classes
* Peripheral arterial disease
* Symptomatic carotid artery disease
o Type 2 Diabetes uncontrolled by pharmacotherapy
o Obstructive sleep apnea as documented by a sleep study


Indication Coverage Criteria (polysomnography) (see Related Policies). AND

* Participation in a physician administered weight reductionprogram lasting at least six continuous months within the two year period before surgery is considered. o Evidence of active participation documented in the medical record includes:

* Weight

* Current dietary program (MediFast, OptiFast)

* Physical activity (eg, exercise/work-out program) OR

* Documentation of participation in a structured weight reduction program such as as Weight Watchers or Jenny Craig is an acceptable alternative if done in conjuction with physician supervision AND

* Psychological evaluation and clearance by a licensed mental health provider to rule out psychological disorders, inability to provide informed consent, or inability to comply with pre- and post-surgical requirements

Note: A physician’s summary letter alone is not sufficient documentation. Patient selection criteria for adolescents less than 18 years of age

Bariatric (weight loss) surgery in adolescents may be considered medically necessary when ALL of the following criteria are met:

* The health plan contract allows bariatric surgery for those younger than 18 years of age AND

* The adolescent meets the same patient selection criteria as an adult AND

* The facility has experienced staff to support adolescents including psychosocial and informed consent issues for bariatric surgery

Indication Coverage Criteria

Refer to member contract language for benefit determination on treatment of obesity for adolescents. Covered bariatric (weight loss) surgeries

The following bariatric (weight loss) surgery procedures may be considered medically necessary when criteria are met:
* Adjustable gastric banding–laparoscopic
* Biliopancreatic bypass (ie, the Scopinaro procedure) with duodenal switch–open or laparoscopic
* Gastric bypass using a Roux-en-Y anastomosis–open or laparoscopic
* Sleeve gastrectomy Surgeon and facility requirements
Bariatric (weight loss) surgery should be performed:
* By a surgeon with specialized training and experience in the bariatric surgery procedure used AND
* In an institution (facility or hospital) that includes a comprehensive bariatric surgery program AND
* Any device used for bariatric surgery must be FDA approved for that purpose and used according to the labeled indications Revision bariatric surgery to correct complications

Revision bariatric (weight loss) surgery (such as replacement and/or removal of an adjustable gastric band, surgical repair or reversal, or conversion to another covered bariatric surgical procedure) may be considered medically necessary to correct complications from the primary bariatric procedure including, but not limited to:
* Band erosion, slippage, leakage, herniation or intractable nausea/vomiting that cannot be corrected with manipulation or adjustment
* Hypoglycemia or malnutrition related to non-absorption
* Obstruction
* Staple-line failure (eg, Gastrogastric fistula)
* Stricture
* Ulceration
* Weight loss of 20% or more below ideal body weight
* Coverage for bariatric surgery is available under the individual’s


Indication Coverage Criteria current health benefit plan Reoperation bariatric  surgery for inadequateweight loss

In the absence of a technical failure or major complication, individuals with weight loss failure (not described above) must meet the initial medical necessity criteria for bariatric surgery Cholecystectomy Routine cholecystectomy (gallbladder removal) may be considered medically necessary when performed with bariatric surgery.

Hiatal hernia repair Repair of a hiatal hernia during bariatric surgery may be considered medically necessary for a preoperative diagnosis of hiatal hernia with clinical indications for surgical repair. Repair of a hiatal hernia performed at the time of bariatric surgery in the absence of preoperative clinical indications for surgical repairis considered not medically necessary Routine liver biopsy Routine liver biopsy during obesity surgery is considered not medically necessary in the absence of preoperative signs or symptoms of liver disease.(eg, elevated liver enzymes, enlarged liver)

Bariatric surgery for a BMI less than 35 kg/m2

Bariatric (weight loss) surgery is considered not medically necessary for patients with a BMI less than 35 kg/m2.

Bariatric surgery to treat conditions other than morbid obesity

Bariatric surgery is considered investigational for the treatment of any condition other than morbid obesity, including, but not limited to diabetes, gastroesophageal reflux disease (GERD), or gastroparesis

Non-covered bariatric surgeries/procedures

Vertical banded gastroplasty (stomach stapling) is considered not medically necessary as a treatment for obesity due to too many long-term complications.

The following weight loss (bariatric) surgery procedures are considered investigational for the treatment of morbid obesity:
* Biliopancreatic bypass without duodenal switch
* Gastric bypass using a Billroth II type of anastomosis (minigastric bypass)
* Laparoscopic gastric plication

Indication Coverage Criteria

* Long-limb gastric bypass procedure (ie, >150 cm)
* Single anastomosis duodenoileal bypass with sleeve gastrectomy
* Two-stage bariatric surgery procedures (eg, sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time)
* Vagus nerve blocking (eg, the VBLOC device or Maestro®) (See related medical policy 7.01.150)
* Endoscopic procedures as a primary bariatric procedure or as a revision procedure including but not limited to:
o Insertion of the StomaphyX™ device
o Insertion of a gastric balloon (eg, Orbera®)
o Endoscopic gastroplasty
o Use of an endoscopically placed duodenal-jejunal sleeve
o Aspiration therapy device (eg, AspireAssist®)

Documentation Requirements
The medical records submitted for review should document that medical necessity criteria are met. The record should include clinical documentation of ALL THREE (3) criteria:

1. A body mass index (BMI) greater than 40 kg/m2, or BMI greater than 35 kg/m2 with at least ONE (1) of the following conditions:
o Established coronary heart disease
o Other atherosclerotic disease
o Type 2 diabetes uncontrolled by medications
o Obstructive sleep apnea as documented by a sleep study
2. Completion of a physician administered weight-loss program that:
o Lasted for at least six (6) months in a row
o Took place within two (2) years before the proposed weight loss surgery
o Demonstrates in the medical record that the member actively took part in the program, as well as include member’s weight, the current dietary program (MediFast, OptiFast) and banded gastroplasty



Body Mass Index Calculation Morbid obesity, also known as clinically severe obesity, is measured using the body mass index (BMI). Severe obesity is weight-based and is defined as a BMI greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with obesity-associated health conditions. BMI is calculated by dividing a patient’s weight (in kilograms) by height (in meters) squared.
* To convert pounds to kilograms, multiply pounds by 0.45
* To convert inches to meters multiply inches by 0.0254
* Click here for BMI calculation.

Evidence Review Description

Bariatric surgery is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous surgical techniques available. While these techniques have different mechanisms of action,the result is a smaller gastric pouch that leads to restricted eating. However, these surgeries may lead to malabsorption of nutrients or eventually to metabolic changes .

Background

Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, prostate; for women: breast, uterine, ovarian), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as “those patients with a BMI of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes.”1 Resolution (cure) or improvement of type 2 diabetes (T2D) after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to the treatment of T2D.

The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional antidiabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, eg, glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. GIP acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. PYY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

Types of Bariatric Surgery Procedures

The following summarizes the most common types of bariatric surgery procedures.

Open Gastric Bypass

The original gastric bypass surgeries were based on the observation that postgastrectomy patients tended to lose weight. The current procedure involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (ie, a gastrojejunal anastomosis). Thus, the flow of food bypasses the duodenum and proximal small bowel. The procedure may also be associated with an unpleasant “dumping syndrome,” in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting. The dumping syndrome may further reduce intake, particularly in “sweets eaters.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications than with other gastric restrictive procedures, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia, all of which can be corrected by oral supplementation. Another concern is the ability to evaluate the “blind” bypassed portion of the stomach. Gastric bypass may be performed with either an open or laparoscopic technique.


Note: In 2005, the CPT code 43846 was revised to indicate that the short limb must be 150 cm or less, compared with the previous 100 cm. This change reflects the common practice in which the alimentary (ie, jejunal limb) of a gastric bypass has been lengthened to 150 cm. This length also serves to distinguish a standard gastric bypass with a very long, or very, very long gastric bypass, as discussed further here.

Laparoscopic Gastric Bypass

CPT code 43644 was introduced in 2005 and described the same procedure as open gastric bypass (CPT code 43846), but performed laparoscopically.

Adjustable Gastric Banding

Adjustable gastric banding (CPT code 43770) involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the gastric band; therefore, the rate-limiting stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions, if necessary, are relatively simple.

Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the Food and Drug Administration (FDA) for marketing in the United States. The first to receive FDA approval was the LAP-BAND (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND® system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame).

It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."


In 2011, FDA-labelled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m2 with at least 1 obesity-related comorbid condition. The second adjustable gastric banding device approved by FDA through the premarket approval process is the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are:

“Th[e REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

Sleeve Gastrectomy

A sleeve gastrectomy (CPT code 43775) is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion [BPD] with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum and avoiding the dumping syndrome (overly rapid transport of food through the stomach into intestines) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a 2-stage procedure for very high risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and, thus, reduce the risk of a subsequent more extensive malabsorptive procedure (eg, BPD).

Biliopancreatic Bypass Diversion

The BPD procedure (also known as the Scopinaro procedure; CPT code 43847) developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

a. A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
b. A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.
c. A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.
d. A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, ie, creating selective malabsorption. The length of the common segment will influence the degree of malabsorption.
e. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to BPD, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, several case reports have noted liver failure resulting in death or liver transplant.

BPD With Duodenal Switch

CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is a variant of the BPD previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the BPD, to create the alimentary limb. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum. The sleeve gastrectomy also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the BPD, ie, producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

Vertical-Banded Gastroplasty

Vertical-banded gastroplasty (VBG; CPT code 43842) was formerly one of the most common gastric restrictive procedures performed in the United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. In order to create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of the stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include  esophageal reflux, dilation, or obstruction of the stoma, with the latter 2 requiring reoperation. Dilation of the stoma is a common reason for weight regain. VBG may be performed using an open or laparoscopic approach.

Long-Limb Gastric Bypass (ie, >150 cm)

Variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures (CPT code 43847), which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways (eg, resection or stapling along the  horizontal or vertical axis). Unlike the traditional gastric bypass, which is a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb (


Laparoscopic Malabsorptive Procedure CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the code does not specifically describe any specific malabsorptive procedure.

Weight Loss Outcomes

There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. EBW is defined as actual weight minus “ideal weight” and “ideal weight” is based on 1983 Metropolitan Life Insurance height-weight tables for medium frame.

These 2 reporting methods are generally preferred over the absolute amount of weight loss, because they reflect the ultimate goal of surgery: to reduce weight to a range that minimizes obesity-related morbidity. Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals. There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. Table 1 summarizes the variations in reporting weight loss outcomes.


Durability of Weight Loss Weight change (ie, gain or loss) at yearly intervals is often reported. Weight loss at 1 year is considered the minimum length of time for evaluating these procedures; weight loss at 3 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery. Short-Term Complications (Operative and Perioperative Complications
In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative

complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary
complications (eg, pneumonia, myocardial infarction).
Reoperation Rate
Reoperation may be required to either “take down” or revise the original procedure.
Reoperation may be particularly common in VBG due to pouch dilation.


Long-Term Complications (Metabolic Adverse Events, Nutritional Deficiencies)

Metabolic adverse events are of particular concern in malabsorptive procedures. Other longterm complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric-banding surgeries. Improved Health Outcomes in Terms of Weight-Related Comorbidities Aside from psychosocial concerns, which may be considerable, one motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (ie, increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported.
30>150>

Medicare inpatient-only or hospital only Procedure

The medicare hospital-only list refers to CPT and services that CMS usually only paid in the hospital environment and thus does not pay for under OPPS. Most of the hospital-only CPTs are operating processes that can be complicated, difficult and/or involve hospital care and co-ordinated care. Surgeons must be conscious of the processes listed because of the potential effect on reimbursement and hospital interactions.

"Inpatient only" services are generally, but not always, surgical services that require inpatient care because of the nature of the procedure, the typical underlying physical condition of patients who require the service, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged.

No payment is made for an “inpatient-only” procedure submitted on the outpatient hospital type of bill, 13X. No payment is made for other services rendered on the same day as the “inpatient only” procedure.

An example of an “inpatient only” service is CPT code 33513, “Coronary artery bypass, vein only; four coronary venous grafts.”

Changes to the Inpatient-Only List (IPO) for CY 2019

The Medicare Inpatient-Only (IPO) list includes procedures that are typically only provided in the inpatient setting and therefore are not paid under the OPPS. For CY 2019, CMS is removing four procedures from the IPO list. CMS is also adding one procedure to the IPO list.

Example changes in the list during 2019

2019 Bariatric Surgery: Is the Surgery Medicare Inpatient Only or not?

43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less) 43659 Unlisted laparoscopy procedure, stomach
43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption
43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy)
43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than verticalbanded gastroplasty
43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorptio
43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)

Inpatient-only procedure performed in outpatient setting within payment window

If an "inpatient-only" procedure is performed in the outpatient setting, and the patient is subsequently admitted as an inpatient, the "inpatient-only procedure" can be reported on the inpatient claim when the services are:

* Provided on the date of inpatient admission
* Provided within 3 days of inpatient admission
* Deemed related to inpatient admission per the payment window policy


Inpatient-only Services


CMS to define the services for which payment under the OPPS is appropriate and the Secretary has determined that the services designated to be “inpatient only” services are not appropriate to be furnished in a hospital outpatient department.  “Inpatient only” services are generally, but not always, surgical services that require inpatient care because of the nature of the procedure, the typical underlying physical condition of patients who require the service, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged.  An example of an “inpatient only” service is CPT code 33513, “Coronary artery bypass, vein only; four coronary venous grafts.” 

The designation of services to be “inpatient-only” is open to public comment each year as part of the annual rulemaking process.  Procedures removed from the “inpatient only” list may be appropriately furnished in either the inpatient or outpatient settings and such procedures continue to be payable when furnished in the inpatient setting.


There is no payment under the OPPS for services that CMS designates to be “inpatient-only” services.  These services have an OPPS status indicator of “C” in the OPPS Addendum B and are listed together in Addendum E of each year’s OPPS/ASC final rule. For the most current Addendum B and for Addendum E published with the OPPS notices and regulations, see http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Excluding the handful of exceptions discussed below, CMS does not pay for an “inpatient-only” service furnished to a person who is registered in the hospital as an outpatient and reports the service on the outpatient hospital bill type (TOB 13X).  CMS also does not pay for all other services on the same day as the “inpatient only” procedure.

There are two exceptions to the policy of not paying for outpatient services furnished on the same day with an “inpatient-only” service that would be paid under the OPPS if the inpatient service had not been furnished:

Exception 1:  If the “inpatient-only” service is defined in CPT to be a “separate procedure” and the other services billed with the “inpatient-only” service contain a procedure that can be paid under the OPPS and that has an OPPS SI=T on the same date as the “inpatient-only” procedure or OPPS SI = J1 on the same claim as the “inpatient-only” procedure, then the “inpatient-only” service is denied but CMS makes payment for the separate procedure and any remaining payable OPPS services.  The list of “separate procedures” is available with the Integrated Outpatient Code Editor (I/OCE) documentation.  See http://www.cms.gov/Medicare/Coding/OutpatientCodeEdit/.

Exception 2:  If an “inpatient-only” service is furnished but the patient expires before inpatient admission or transfer to another hospital and the hospital reports the “inpatient only” service with modifier “CA”, then CMS makes a single payment for all services reported on the claim, including the “inpatient only” procedure, through one unit of APC 5881, (Ancillary outpatient services when the patient dies.)  Hospitals should report modifier CA on only one procedure

HCPCS code and Description

H1000 Prenatal care, at-risk assessment
H1001 Prenatal Care, At Risk Enhances Service;
H1004 Prenatal Care, At-Risk Enhanced; Follow Up Home Visit

FPC–Frequency of prenatal care

Prenatal standalone visits CPT codes:  99500, 0500F, 0501F, 0502F    
HCPCS Code : H1000-H1004   and H1005

The percentage of expected prenatal visits based on weeks of gestation at delivery and months of pregnancy when patient enrolled in Medicaid:

• Every four weeks for the first 28 weeks of pregnancy
• Every two-three weeks for the next seven weeks
• Weekly thereafter until delivery


Prenatal and Postpartum Care (PPC)

The percentage of deliveries of live births on or between November 6 of the year prior to the measurement year and November 5 of the measurement year. For these women, the measure assesses the following facets of prenatal and postpartum care.

• Timeliness of Prenatal Care. The percentage of deliveries that received a prenatal care visit as a member of the organization in the first trimester, on the enrollment start date or within 42 days of enrollment in the organization.

• Postpartum Care. The percentage of deliveries that had a postpartum visit on or between 21 and 56 days after delivery.


UHC Florida Guidelines
** Prenatal care must be billed separately from the delivery and postpartum care.
** FL providers are to submit prenatal codes H1001 and/or H1000.
** Up to 14visits are allowed for prenatal care& up to 18 visits are allowed for high risk prenatal care.
** Up to 3postpartum visits are allowed within 90 days following delivery, per recipient.
** Delivery of two or more infants from a single pregnancy, by different delivery method, separately.  Same delivery method is non-covered.

Per Florida State Requirements, Birthing Centers (POS 25) are reimbursed the facility fee with procedure code 59409 and Provider delivery services in a birthing center with code 59410


Prenatal and Postnatal Home Visits   - Medicaid insurance billing

Home visits can be included in the management plan of pregnant members when there is a need to assess the home environment and its implications for the management of prenatal and postnatal care; to provide direct care; to encourage regular visits for prenatal care; to provide emotional
support; and to determine educational needs.

Visits may be provided by one of the following Utah licensed qualified providers:
**  Registered Nurse
**  Certified Nurse-Midwife   
**  Certified Nurse Practitioner
**  Social Service Worker
**  Certified Social Worker
**  Licensed Practical Nurse, who works under the supervision of a registered nurse and has additional training and experience to be a perinatal care coordinator
**  Health Educator must have either a Bachelor’s degree in health education with a minimum of three years’ experience, at least one of which must be in a medical setting, a Master’s degree with a minimum of one year of experience working in a medical setting or with pregnant women, or a Bachelor’s degree and a certificate showing completion of a certification examination in health education.

The service is reported using HCPCS H1004 Prenatal Care, At-Risk Enhanced; Follow Up Home Visit.  Limited to six visits during a 12-month period.


Risk Assessment  

Risk assessment is the systematic review of relevant member data to identify potential problems and determine a plan for care.  Early identification of high risk pregnancies with appropriate consultation and intervention contributes significantly to an improved perinatal outcome and lowering of maternal and infant morbidity and mortality.   A care plan for high risk members, in addition to standard care, includes referral to or consultation with an appropriate specialist, individualized counseling and services designed to address the risk factor(s) involved.  A care plan for low risk members includes primary care services and additional services specific to the needs of the individual. 

Risk Assessments may be provided by one of the following licensed Medicaid providers:

**  Physician
**  Certified Nurse Practitioner
**  Certified Nurse-Midwife

The service is reported using HCPCS H1000 Prenatal Care, At Risk Assessment for a low risk assessment or HCPCS H1001 Prenatal Care, At Risk Enhances Service; Antepartum Management for high risk assessment.  Limited to two (2) assessments during any 10-month period.

CPT Code Description
99217 Observation care discharge day management (This code is to be utilized to report all services provided to a patient on discharge from outpatient hospital "observation status" if the discharge is on other than the initial date of "observation status." To report services to a patient designated as "observation status" or "inpatient status" and discharged on the same date, use the codes for Observation or Inpatient Care Services [including Admission and Discharge Services, 99234-99236 as appropriate.])

99218 Initial observation care, per day, for the evaluation and management of a patient which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to outpatient hospital "observation status" are of low severity. Typically, 30 minutes are spent at the bedside and on the patient's hospital floor or unit.

99219 Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to outpatient hospital "observation status" are of moderate severity. Typically, 50 minutes are spent at the bedside and on the patient's hospital floor or unit.

99220 Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified healthcare professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to "observation status" are of high severity. Typically 70 minutes are spent at the bedside and on the patient's hospital floor or unit.


OBSERVATION SERVICES CPT CODES: 99218-99220, 99224 – 99226


Background Observation care is a well-defined set of specific, clinically appropriate services,

which include:

• Ongoing short term treatment,
• Assessment,
• Reassessment

These are furnished while a decision is being made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital.

Observation services are commonly ordered for patients who present to the emergency department and who then require a significant period of treatment or monitoring in order to make a decision concerning their admission or discharge.

In only rare and exceptional cases do reasonable and necessary outpatient observation services span more than 48 hours.

In the majority of cases, the decision whether to discharge a patient from the hospital following resolution of the reason for the observation care or to admit the patient as an inpatient can be made in less than 48 hours, usually in less than 24 hours.


Who May Bill

• Contractors pay for initial observation care billed by only the physician/non physician practitioner who have hospital admitting privileges, who ordered hospital outpatient observation services, and who was responsible for the patient during his/her observation care. A physician who does not have inpatient admitting privileges but who is authorized to furnish hospital outpatient observation services may bill these codes.

• For a physician to bill observation care codes, there must be a medical observation record for the patient which contains dated and timed physician’s orders regarding the observation services the patient is to receive, nursing notes, and progress notes prepared by the physician while the patient received observation services.

This record must be in addition to any record prepared as a result of an emergency department or outpatient clinic encounter.

• Payment for an initial observation care code is for all the care rendered by the ordering physician on the date the patient’s observation services began. All other physicians who furnish consultations or additional evaluations or services while the patient is receiving hospital outpatient observation services must bill the appropriate outpatient service codes.

- For example, if an internist orders observation services and asks another physician to additionally evaluate the patient, only the internist may bill the initial and subsequent observation care codes. The other physician who evaluates the patient must bill the new or established office or other outpatient visit codes as appropriate.

Significance of Time as a Factor

The inclusion of time as an explicit factor beginning in CPT 1992 is done to assist in selecting the most appropriate level of E/M services. Please note that the specific times expressed in the CPT visitcode descriptors are averages and , therefore, represent a range of times that may be higher or lower depending on actual clinical circumstances.

• Intraservice times are defined as face-to-face time for office and other outpatients visits and as unit/floor time for hospital and other inpatient visits

- Unit/Floor time includes the time present on the patient’s hospital unit and at the bedside rendering services for that patient; includes time to establish and/or review patient’s chart, examine the patient, write notes, and communicate with other professionals and the patient’s family.

» Pre and Post-visit time is not included in the time component described in these codes (pre and post include time spent off the patient’s floor performing such tasks as reviewing pathology/radiology findings in another part of the hospital).


Initial Observation Care (CPT code range 99218-99220)

• Included in Initial Observation Care:
- Initiation of observation status
- Supervision of the care plan for observation
- Performance of periodic reassessments
• When a patient receives observation care for less than 8 hours on the same calendar date, the Initial Observation Care, from CPT code range 99218 – 99220, shall be reported by the physician.
• When a patient is admitted for observation care and then is discharged on a different calendar date, the physician shall report Initial Observation Care, from CPT code range 99218 – 99220, and CPT observation care discharge CPT code 99217.
• To report services provided to patient who is admitted to the hospital after receiving hospital observation care services on the same date, see initial hospital care notes in the American Medical Association (AMA) Current Procedural Terminology (CPT) Publication.
• To report hospital admission on a date subsequent to the date of observation status, use appropriate initial hospital care codes (CPT 99221 – 99223)
• Observation status that is initiated in the course of an encounter in another site of service (eg. hospital emergency department, office, nursing facility) all E/M services provided by the supervising physician or other qualified health care professional in conjunction with initiating “observation status” are  considered part of the initial observation care when performed on the same date.
- The level of service reported should include the services related to initiating “observation status” provided in the other sites of service as well as in the observation setting
• On the rare occasion when a patient remains in observation care for 3 days, the physician shall report an initial observation care code (99218-99220) for the first day of observation care, a subsequent observation care code (99224-99226) for the second day of observation care, and an observation care discharge CPT code 99217 for the observation care on the discharge date.
• Admitted and discharges from observation or inpatient status on the same date report CPT codes 99234-99236 as appropriate; do NOT report observation discharge in conjunction with a hospital admission.
• These codes may NOT be utilized for post-operative recovery if the procedure is considered part of the surgical “package.” Subsequent Observation Care (CPT code range 99224 – 99226)

• All levels of subsequent observation care include:
- Reviewing the medical record
- Reviewing the results of diagnostic studies
- Changes in the patient’s status (ie, changes in history physical condition, and response to management) since the last assessment.

• When observation care continues beyond three days, report subsequent observation care for each day between the first day of observation care and the discharge date When a patient receives observation care for a minimum of 8 hours, but less than 24 hours, and is discharged on the same calendar date, observation or inpatient care services (including admission and discharge services) CPT code range.

Discharge Observation Care (CPT code 99217)

• Included in CPT code 99217
- Final Examination of the patient
- Discussion of the hospital stay
- Instructions for continuing care
- Preparation of discharge records

• For observation or inpatient hospital care including the admission and discharge of the patient on the same date see CPT codes 99234 - 99236.


OVERVIEW FROM oxford insurance

Initial Observation Care CPT® codes 99218-99220 and subsequent Observation Care CPT codes 99224-99226 are used to report evaluation and management (E/M) services provided to new or established patients designated as "observation status" in a hospital. Observation service (including admission and discharge) CPT codes 99234-99236 are used to report E/M services provided to patients admitted and discharged on the same date of service.


For the purpose of this policy, the Same Specialty Physician or Other Qualified Health Care Professional is defined as a physician and/or health care professional of the same group and same specialty reporting the same Federal Tax Identification number.

REIMBURSEMENT GUIDELINES

Initial Observation Care

The physician supervising the care of the patient designated as "observation status" is the only physician who can report an initial Observation Care CPT code (99218-99220). It is not necessary that the patient be located in an observation area designated by the hospital, although in order to report the Observation Care codes the physician must:

** Indicate in the patient's medical record that the patient is designated or admitted as observation status;
** Clearly document the reason for the patient to be admitted to observation status; and
** Initiate the observations status, assess, establish and supervise the care plan for observation and perform periodic reassessments.

The CPT codebook states that "When "observation status" is initiated in the course of an encounter in another site of service (e.g., hospital emergency department, office, nursing facility) all evaluation and management services provided by the supervising physician or other qualified health care professional in conjunction with initiating "observation status" are considered part of the initial Observation Care when performed on the same date. The Observation Care level of service reported by the supervising physician should include the services related to initiating "observation status" provided in the other sites of services as well as in the observation setting."

Oxford follows the Centers for Medicare and Medicaid Services' (CMS) Claims Processing Manual which provides the instructions, "for a physician to bill the initial Observation Care codes [99218-99220], there must be a medical observation record for the patient which contains dated and timed physician's admitting orders regarding the care the patient is to receive while in observation, nursing notes, and progress notes prepared by the physician while the patient was in observation status. This record must be in addition to any record prepared as a result of an emergency department or outpatient clinic encounter."

Consistent with CMS guidelines, Oxford requires that an Initial Observation Care CPT code (99218-99220) should be reported for a patient admitted to Observation Care for less than 8 hours on the same calendar date.

QUESTIONS AND ANSWERS

Q: Can Observation Care codes 99217 and codes 99218-99220 be reported on the same date of service?
A: No. CPT codes 99234-99236 should be reported for patients who are admitted to and discharged from observation status on the same calendar date for a minimum of 8 hours but less than 24. An initial Observation Care code (99218-99220) should be reported for patients admitted and discharged from observation status for less than 8 hours on the same calendar date. CPT code 99217 can only be reported for a patient discharged on a different calendar date.

Q: Does the patient need to be in an observation unit in order to report the Observation Care codes?
A: It is not necessary that the patient be located in an observation area designated by the hospital as long as the medical record indicates that the patient was admitted as observation status and the reason for Observation Care is documented.


Observation Services billing guidelines

Hospital observation services (procedure codes 1-99217, 1-99218, 1-99219, and 1-99220) is for professional services for a period of more than 6 hours, but fewer than 24 hours, regardless of the hour of the initial contact, whether or not the client remains under physician care beyond midnight.

Observation may take place in any patient care area of the hospital or outpatient setting.

Observation care discharge day management may be billed to report services provided to a client upon discharge from observation status if the discharge date is other than the initial date of admission. Procedure codes 1-99211, 1-99212, 1-99213, 1-99214, 1-99215, 1-99218, 1-99219, and 1-99220 will be denied if billed on the same day as procedure codes 1-99217, 1-99234, 1-99235, and 1-99236 by the same provider. Evaluation and management services provided in any place of service other than the inpatient hospital, billed on the same day as a physician observation visit, by the same provider, will be denied.

If a physician observation visit (procedure codes 1-99217, 1-99218, 1-99219, 1-99220, 1-99234, 1-99235, and 1-99236) is billed on the same day as prolonged services (procedure codes 1-99354 and 1-99355) by the same provider, the prolonged services will be denied as part of another procedure on the same day.

If dialysis treatment and physician observation visits are billed the same day, by the same provider, same specialty, other than Nephrology and Internal Medicine specialists, the dialysis treatment will be paid and the physician observation visit will be denied.

Prolonged Physician Services Prolonged services may be provided in the office, outpatient, or inpatient setting and involve direct (face-toface) client contact that is beyond the usual service and exceeds the time threshold of the following evaluation and management codes being billed on that day.

The Medicare Provider Enrollment, Chain, and Ownership System (PECOS) is an online provider and supplier enrollment system used to:

** Submit Medicare enrollment applications
** View and print enrollment information
** Update enrollment information
** Complete the enrollment revalidation process
** Withdraw voluntarily from the Medicare Program
** Track Medicare enrollment applications

This booklet teaches Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers how to use PECOS. Go to the Medicare Provider-Supplier Enrollment National Educational Products listing for information about other provider types.

DMEPOS SUPPLIER STANDARDS, ACCREDITATION, AND SURETY BOND

To enroll or keep your Medicare billing privileges, all DMEPOS suppliers (except certain exempted professionals) must meet supplier and DMEPOS Quality Standards to become accredited. Certain DMEPOS suppliers must also submit a surety bond.

DMEPOS suppliers (except for those exempted eligible professionals and “other persons”) must be accredited prior to submitting a Medicare enrollment application to the National Supplier Clearinghouse (NSC). For more information on these conditions, go to the Centers for Medicare & Medicaid Services (CMS) DMEPOS Enrollment webpage or review the DMEPOS Accreditation fact sheet, which lists exempted eligible professionals.

ONE ACCOUNT, MULTIPLE SYSTEMS

CMS uses several provider enrollment systems. Organizational DMEPOS suppliers must use the Identity & Access Management (I&A) System to name an Authorized Official (AO) to work in CMS systems. The I&A System allows you to:

** Use the National Plan and Provider Enumeration System (NPPES) to apply for and manage National Provider Identifiers (NPIs)

** Use PECOS to complete Medicare enrollment or update or revalidate your current enrollment information

** Register to get Electronic Health Record (EHR) incentive payments for eligible professionals and hospitals who adopt, use and upgrade, or demonstrate meaningful EHR certified technology use Individual DMEPOS Suppliers (for example, sole proprietorships) Physicians and non-physician practitioners (NPPs) who are DMEPOS suppliers may use their I&A System user ID and password to access PECOS. If you do not already have an I&A System account, go to the I&A System User Registration page and enter the information to open an account. For help, go to the I&A System Quick Reference Guide and click the “How to Setup Your Account if you are a Sole Owner” link.

Once you have your DMEPOS ID and password, skip to Step 3. As an individual DMEPOS supplier, you do not need an AO or other delegated user.

Organizational DMEPOS Suppliers System Users

CMS allows various types of organizations and users to work in their systems. The type of user  depends on the individual’s relationship with you and the duties they perform in your practice. A  DMEPOS supplier organization must appoint an AO to act on behalf of the organization to manageconnections and staff, including appointing and approving other authorized PECOS users. The organization must identify the AO in the enrollment application. The AO must have ownership or managing control in the DMEPOS supplier organization.

NOTE: CMS recommends using the same I&A System-appointed AO and any Delegated Officials (DOs) in PECOS. The AO and DOs must have the right to legally bind the company, are responsible for approving the system staff, and are approved in the I&A System based on their PECOS status. For more information go to the CMS External User Services (EUS) answers to frequently asked questions webpage.

STEP 1: AUTHENTICATE AO CREDENTIALS

The organization must choose, invite, and authenticate you as their “Authorized Official” (AO) to work in PECOS for them. That individual must meet the AO regulatory definition. An AO is, for example, a chief executive officer, chief financial officer, general partner, chairman of the board, or direct owner to whom the organization gives the legal authority to enroll it in the Medicare Program.

Respond to your employer’s AO invitation or initiate the request yourself. When you are the confirmed AO, use PECOS for your organizational DMEPOS supplier. You may choose to give this responsibility to a DO, Staff End User (SEU), or surrogate. As an AO, you are responsible for approving system user requests to work in PECOS for the organizational DMEPOS supplier. Regularly check your email and take the requested actions. AOs may also appoint DOs to act for them. For more information on registering for an I&A System account or enrolling as an AO, go to the I&A System Quick Reference Guide and the I&A Frequently Asked Questions (FAQs) and click the “Create Your Account” link.



ENTER PECOS ENROLLMENT INFORMATION
After CMS approves your I&A System registration, submit your organizational DMEPOS supplier application. PECOS is a scenario-driven application—it presents a series of questions to recover only the information needed to process your specific enrollment scenario. Follow these instructions:

1. Log in to PECOS.

2. Continue with an existing enrollment or create a new application.

3. When PECOS determines your enrollment scenario and you confirm it is correct, it shows the topics for submitting your application. To complete each topic, enter the necessary information.

4. At the end of the data entry process, PECOS: Confirms you entered all necessary data Shows a list of the Medicare Administrative Contractor/National Supplier Clearinghouse (MAC/NSC) documents to submit for review (the NSC is the MAC responsible for processing all DMEPOS applications)


STEP 4: RESPOND TO MEDICARE CONTRACTORS’ REQUESTS FOR MORE INFORMATION
Respond to information requests within 30 days; otherwise, the MAC/NSC may reject your enrollment.

Your MAC/NSC will not complete processing your PECOS enrollment application without your electronic signature, application fee, and necessary supporting documentation. The effective application enrollment filing is the date the MAC/NSC gets your electronic signature.

You can check your PECOS enrollment application status in two ways:

1. Log in to PECOS and click the “View Enrollments” link. In the “Existing Enrollments” section, find the application. The system shows the application status.

2. To see your enrollment status, go to the PECOS homepage and click “Application Status” under “Helpful Links.” You do not need to log in to PECOS to use this application status feature.

STEP 5: KEEP YOUR PECOS ENROLLMENT INFORMATION UP TO DATE Report a Medicare enrollment change using PECOS. You must report a change of ownership or control, a change in practice location, and any final adverse legal actions (such as revocation or suspension of a Federal or State license) within 30 days of the reportable event (go to the PECOS FAQs for a definition). Submit all other changes within 90 days of the reportable event. For more information, go to the MLN Matters® Article, Timely Reporting of Provider Enrollment Information Changes.

 

 HCPCS Codes, Level II: Drug Code for Venofer

HCPCS codes are used to identify most drugs and biologics. Venofer® (iron sucrose) injection, USP has been assigned the following drug-specific HCPCS code (also known as a J-code):

J1756 Injection, Iron Sucrose, 1 mg - Drug code Venofer

J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®

Each 1 mg of Venofer is equivalent to one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form. Service units are very important and must be included on every claim. Here are some Venofer examples:

• One (1) vial (2.5 mL) or 50 mg = 50 service units

• One (1) vial (5 mL) or 100 mg = 100 service units

• One (1) vial (10 mL) or 200 mg = 200 service units

Medicaid

Medicaid may also cover Venofer when it is used for its FDA-approved indications. Medicaid patient eligibility guidelines and coverage policies vary from state to state, and some states maintain mandatory review criteria for including a product as an approved drug or service. Medicaid programs may base their coverage guidelines on Medicare or commercial payers or have more restrictive coverage. Most Medicaid programs in 2020 require prior authorization for branded drugs like Venofer.

III. Coding

Proper coding of services is key to your success in terms of billing for Venofer® (iron sucrose) injection, USP given in your office or clinic. Why is coding so crucial? Codes are simply an abbreviated way of describing the appropriateness and medical necessity of treatments given in your facility. This is what codes describe, in a nutshell:

• ICD-10-CM/diagnosis codes

show medical necessity of Venofer in terms of the reason for giving it

• CPT (HCPCS Level I) codes

demonstrate how Venofer was given to the patient

• HCPCS Level II codes

provide evidence of the type of drug and how much of it was given or wasted

More details are documented below.

A. International Classification of Disease, 10th Edition, Clinical Modification (ICD-10-CM) Diagnosis Coding for Venofer

ICD-10-CM diagnosis codes identify the patient’s diagnosis and inform insurers of why a service was provided. It should be simple, but it can get difficult with Venofer. First of all, there is a coding guideline that states, “Certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, the ICD-10-CM has a coding convention that requires the underlying condition be sequenced first, if applicable, followed by the manifestation.”5  On the Venofer package insert, the indication is for iron deficiency anemia in chronic kidney disease. So, per coding guidelines, the chronic kidney disease is the underlying condition (etiology), and the resulting condition (manifestation) is the iron deficiency anemia. Therefore, it is very important that 2 codes are billed—the one for CKD and the one for iron deficiency anemia.

Venofer is approved for the treatment of iron deficiency anemia in adult patients with CKD. In addition, it is also approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with IDA, whether or not they are on ESA therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritonealdialysis patients with IDA who are on ESA therapy. American Regent makes no representation that Venofer is safe and effective in other patients or that it is permissible or legal to use for other indications. 

General Guidelines

Understanding today’s complex world of healthcare reimbursement requires a good sense of direction. Even though Venofer® (iron sucrose) injection, USP has been in the marketplace since the year 2000 as a trusted iron product, the reimbursement landscape changes daily. Constant shifts in Medicare rules, payer policies, billing edits (eg, Medically Unlikely Edits), and medical coding are reasons to refer to this guide, whether you have billed for Venofer once or a hundred times.

Caring for patients with chronic kidney disease (CKD) requires that providers work closely with third-party payers to ensure that they are paid fully and fairly

for medically necessary healthcare items and services. American Regent, the manufacturer of Venofer, wants prescribing providers to better understand the complexities of reimbursement. The company has prepared this guide to assist you with common questions about Venofer and its reimbursement.

This guide provides general coverage, coding, and updated payment information about Venofer to help you better understand the policies of the Medicare program and other third-party payers. The guide should also help you avoid troublesome denials based on real-world data. The goal is to help you get paid fully and fairly for every claim.

If you need more help, American Regent’s VenAccess™ Reimbursement Hotline is available to provide assistance and to answer all of your payment questions.

This hotline can be reached by calling 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.

II. Coverage

For those of you who are newer to billing, coverage refers to 2 things. First, coverage is contingent upon whether the patient’s policy covers a particular aspect of care. For example, if a patient has major medical coverage without prescription coverage, self-administered (prescription) drugs probably will not be covered under that benefit. But non-self-administered (“buy-and-bill”) drugs, like Venofer® (iron sucrose) injection, USP, will be covered in a doctor’s office or hospital outpatient setting under the major medical benefit as long as certain parameters are met, as described in the next paragraph.

The second aspect of coverage is whether a particular payer, per their own policies, will cover a particular item or service. Generally, a drug is covered if it is FDA-approved, given for the diagnoses that the FDA approved it for, and administered per the package insert, which is an outline of what the FDA approved for that drug. Added to that, the drug must be necessary and appropriate for a specific patient, which means that the patient must have the correct diagnosis and be eligible, in terms of health status, to receive the product. Both public and private payers may modify or widen this coverage by issuing policies that specify how and when they will cover a product like Venofer.

Medicare Coverage

Medicare is likely to cover Venofer and its administration when used for its FDA- approved indication and when administered per its package insert. Venofer is approved for the treatment of iron deficiency anemia (IDA) in adult patients with CKD. Under Medicare Part B (the doctor’s office), it must be given incident to a provider’s service. In order to meet all the general requirements for coverage under the incident-to provision, an FDA-approved drug or biologic must be: a) of a form that is not usually self-administered; b) furnished by a physician practice; and c) administered by the physician or by auxiliary personnel employed by the physician and under the physician’s personal supervision.1

The charge, if any, for the drug or biologic must be included in the physician’s bill, and the cost of the drug or biologic must represent an expense to the physician. Drugs and biologics furnished by other health professionals (nurse practitioners, physician assistants, and clinical nurse specialists with Medicare billing capability) may also meet these requirements. (See sections 170, 180, 190, and 200 in Chapter 15 of the Medicare Benefit Policy Manual for specific instructions.)1

In addition, Venofer® (iron sucrose) injection, USP is approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with iron deficiency anemia, whether or not they are on erythropoietin-stimulating agent (ESA) therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritoneal-dialysis patients with iron deficiency anemia who are on ESA therapy. Patients on dialysis are covered by a separate benefit under Medicare Part A. Additionally, the Medicare rules for dialysis facilities include bundled payments. The bundled per-treatment payment includes drugs, laboratory services, supplies, and capital-related costs related to furnishing maintenance dialysis. So, Venofer may be covered but not paid for separately in dialysis facilities.2

Additionally, for dialysis patients, there is a National Coverage Determination by Medicare, which takes precedence over local intermediary decisions. The National Coverage Determination states, “Effective October 1, 2001, Medicare also covers iron sucrose injection as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.”3

For non-dialysis patients, Medicare Part B coverage may be determined by local carriers or Medicare Administrative Contractors (MACs), who are responsible for issuing local coverage determinations (LCDs) that detail coverage guidelines.4

 Additionally, carriers and MACs are responsible for processing Medicare claims. Prior authorization (PA) is not required under Part B. Also, Medicare coverage policies must be drafted and approved by a group of clinicians in your area called the Carrier Advisory Council (CAC). This body gives the public a voice in Medicare policy. Please see the CMS.gov website (link below) for more information.*

Commercial Payers and Medicare Advantage

Medicare Part C is called Medicare Advantage (MA) and currently covers approximately 36.5% of Medicare patients. MA plans are private plans that must cover the same breadth of services that traditional Medicare does. But, other than that, MA behaves like a commercial payer and not like Medicare in terms of coverage and payment. Almost all private payers these days, including MA, require prior authorization for branded drugs like Venofer® (iron sucrose) injection, USP. This will tell you definitively whether a commercial plan will cover Venofer for your patient.

Frequent benefit investigation (sometimes known as insurance verification) is necessary for commercial patients—particularly if they are Affordable Care Act (ACA) patients with premiums or are on employer-based insurance. If patients do not pay premiums or they change jobs, this can impact insurance coverage. Healthcare insurance policies also have various levels of coverage and may have “caps” for drugs. This needs to be ascertained for each policy. Additionally, commercial payers often publish policies regarding iron products like Venofer. You should check the payer policies for Venofer each time you infuse a patient and each time you initiate a new course of iron treatment with Venofer. You can also verify how a policy applies to your patient at the time of prior authorization.

National Drug Codes (NDCs)

National Drug Codes are becoming more prevalent in billing for drugs. Many plans now require NDCs on every claim. The most prominent payers to require NDCs are UnitedHealthcare and all Medicaid plans.

The NDC for Venofer (and all drugs) should be applied to the claim in a 5-4-2 format, meaning that there should be 5 digits, then 4 digits, then 2 digits on the claim, like this:

Venofer is preservative free and available as 50 mg/2.5 mL single-use vials, 100 mg/ 5 mL single-use vials, and 200 mg/10 mL single-use vials. The NDC numbers are:

Drug Payment in the Hospital Outpatient Department

Medicare

Under the Hospital Outpatient Prospective Payment System (HOPPS), drugs and biologics have different payments throughout their product life cycle. Older drugs, like Venofer, that are more than 2 to 3 years after launch, receive either packaged payment or separate payment through their own Ambulatory Payment Classification (APC). The APC is a payment grouping used for hospital outpatient claims as well as ambulatory surgical center (ASC) claims. Each APC group is assigned a preset payment amount, which is intended to cover the hospital’s costs related to the item or service provided. This method of payment ONLY applies to fee-for-service Medicare beneficiaries—not those enrolled in Medicare Advantage Plans.

Some drugs, like Venofer, are packaged based upon a daily predetermined per-encounter rate. That is, if the drug’s per-encounter cost is less than the predetermined threshold, the drug is packaged into the APC of the drug administration for that Venofer encounter.

Medicare groups CPT and HCPCS codes for Venofer® (iron sucrose) injection, USP administration into the corresponding APCs for payment and, thereby, does not pay separately for it. It becomes part of the APC payment for the administration.  The following CPT codes may be used to bill for the administration of Venofer and are assigned to each corresponding APC group for the calendar year 2020:

Denials

All provider-administered (“buy-and-bill”) drugs have complicated payment scenarios based on cost and various payer coverage policies. Moreover, for nonTraditional Medicare payers, prior authorization is needed for all branded drugs, like Venofer® (iron sucrose) injection, USP, to be paid. Thus, denials are common and create much follow-up for providers. Venofer is no exception; however, some of its denials are unique to its indication of iron deficiency anemia in chronic kidney disease. A Clearinghouse database* evidences the following top 5 denial codes for Venofer in 2019, an explanation as to why these may be happening, and how these may be prevented in the buy-and-bill setting

Claim Denial Code #50, Lack of Medical Necessity: This denial code seems to imply that payers are not covering Venofer because the reasons for the administration are not covered. However, in looking at the data, most claims denied under this denial code are not coded correctly in terms of their diagnosis. The top denied ICD-10-CM diagnosis code is D50.9, “unspecified anemia.” Unspecified codes for drugs are very often denied. It is important to use the most specific code that matches individual record documentation. Further, it is also vital to check all individual payer policies for coding guidance and, if they are not available, review the applicable ICD10-CM guidelines to choose the optimal code for payment of Venofer.

Claim Denial Code #11, The Procedure Code and Diagnosis Code Do Not Match: This denial means that the payer expects to see a different diagnosis with the Venofer® (iron sucrose) injection, USP HCPCS code. Again, unspecified codes are a problem, as they are codes that do not convey the diagnosis on the Venofer package insert. Further, there are some claims for diagnoses that are not indicated for Venofer. Please verify coverage and coding guidelines prior to administration of Venofer.

If you receive a Venofer denial and have questions about it, please call the VenAccess™ Reimbursement Hotline at 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.

American Regent has established a toll-free hotline to help physicians and other providers understand payers’ coverage and reimbursement policies for Venofer® (iron sucrose) injection, USP, and when necessary, address reimbursement issues. Specifically, on a limited basis, hotline reimbursement specialists can assist with the following:

• Insurance verifications: Help callers verify payer coverage and reimbursement policies for Venofer. Reimbursement specialists will determine patient benefit levels and discuss potential billing options with patient consent

• Billing assistance: Assist callers with filing claims and understanding the reimbursement policies for Venofer

• Claims appeals: Support callers in appealing denied claims or inadequate reimbursement for Venofer

• Patient assistance: Screen individuals without health insurance who are ineligible for public assistance for enrollment in a product replacement program

Patient information will be kept strictly confidential at all times. Every attempt is made to provide accurate, up-to-date information. The Venofer Reimbursement Hotline cannot guarantee successful reimbursement. To speak with someone at American Regent’s Customer Service or Medical Affairs department, please call 800-645-1706.

Guidelines

Medicare covers Sodium Ferric Gluconate Complex in Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Medicare also covers Iron Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Coverage also includes for parenteral iron in iron deficiency anemia:

• For patients with iron deficiency anemia who do not respond to oral iron supplementation due to malabsorption disorders or patients who have documented intolerance to oral iron supplementation.

• For anemia related to chronic kidney disease.

• Initial treatment of absolute iron deficiency in patients receiving myelosuppressive chemotherapy who have asymptomatic anemia and risk factors for the development of symptomatic anemia requiring transfusion.

For the pregnant beneficiary when iron stores are depleted such that the mother and/or the fetus are at risk of adverse outcomes and oral iron replenishment is either not tolerated or the anemia is of such severity as to require more immediate replenishment. Additionally, use in the peripartum period may be indicated when intra/post-partum hemorrhage is severe and by administering parenteral iron a transfusion may be avoided. This indication does not replace the strong consideration for transfusions when the hemorrhage is potentially life threatening.

APPLICABLE CODES

The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws  that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

HCPCS Code Description

J1756 Injection, Iron Sucrose, 1 mg (Venofer®)

J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®)

When it comes to medical billing and claims submission, understanding the various codes and fields on the CMS 1500 form is crucial. In this comprehensive guide, we will focus on Box 22 and its resubmission codes. Box 22 plays a vital role in indicating the original reference number for resubmitted or corrected claims. We will explore the different resubmission codes associated with Box 22, their purposes, and provide insights into related topics such as the ICN number in medical billing. So let's dive in!

What is Box 22 on the CMS 1500 Form?

The CMS 1500 form, also known as the Health Insurance Claim Form, is used for submitting claims for healthcare services rendered. Box 22, labeled "Resubmission Code/Original Ref. No.," is specifically designated for indicating the original reference number associated with resubmitted or corrected claims [1]

Using re-submission codes (HCFA 1500 claim form: Box 22)

Understanding Resubmission Codes

Resubmission codes play a crucial role in communicating the nature of the claim being submitted. The following resubmission codes are applicable in Box 22 on the CMS 1500 form:

Resubmission Code 6 - Corrected Claim

Resubmission Code 6 is used to indicate a corrected claim. When a claim requires modification or correction due to errors or missing information, the corrected claim is submitted using this code [1]

Resubmission Code 7 - Replacement of Prior Claim

Resubmission Code 7 is utilized when a claim is being submitted to replace a previously submitted claim. This code is used when there is a need to revise a claim due to changes in diagnosis, procedures, or other relevant information [1]

Resubmission Code 8 - Void/Cancel Prior Claim

Resubmission Code 8 is employed when a claim needs to be voided or canceled. It indicates that a previously submitted claim should no longer be considered valid or processed. This code is typically used when errors or inaccuracies are identified in a claim that has already been submitted [1]

The Importance of the Original Reference Number (ICN)

The Original Reference Number, also known as the Claim Reference Number or ICN (Internal Control Number), is a unique identifier assigned to a claim or encounter by the destination payer or receiver. It is used to refer to a previously submitted claim or encounter when resubmitting or correcting claims. The ICN should not be used for original claim submissions. It plays a vital role in maintaining the continuity of information and facilitating efficient claims processing [1]

Locating the ICN Number on a Claim

The ICN number can be found in Loop 2300, Segment REF02, of the EDI file when REF01 is F8 [1]

Frequently Asked Questions (FAQs)

FAQ 1: What is the purpose of Box 22 on the CMS 1500 form?

Answer: Box 22 is used to indicate the original reference number for resubmitted or corrected claims, providing important information for efficient claims processing [1]

FAQ 2: How do I determine the appropriate resubmission code for my claim?

Answer: The resubmission code depends on the nature of the claim. Use Resubmission Code 6 for corrected claims, Code 7 for replacements of prior claims, and Code 8 for voiding or canceling prior claims [1].

FAQ 3: Where can I find the ICN number on a claim?

Answer: The ICN number is located in Loop 2300, Segment REF02, of the EDI file, specifically when REF01 is F8 [1]

 Conclusion

Understanding Box 22 resubmission codes on the CMS 1500 form is essential for accurate claims processing and successful resubmission or correction of claims. Resubmission codes 6, 7, and 8 are used to indicate corrected claims, replacements of prior claims, and voiding or canceling prior claims, respectively. The ICN number plays a crucial role in maintaining claim continuity. By familiarizing yourself with these codes and concepts, you can ensure smoother billing processes and minimize claim-related issues.

Remember to consult official resources and billing guidelines for specific instructions related to your circumstances.

References:

[1] Box 22 Resubmission Code/Original Ref. No. – Therabill. Retrieved from: 

http://www.cms1500claimbilling.com/2010/10/cms-box-22-medicaid-resubmission-code.html