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Date Printed: June 23, 2017: 11:44 AM

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09-J1000-64

Original Effective Date: 04/15/12

Reviewed: 03/13/13

Revised: 11/01/15

Subject: Thiamine HCl Injection (vitamin B-1)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates
           

DESCRIPTION:

Thiamine, or vitamin B1, is a water-soluble vitamin found in such foods as yeast, cereal grains, legumes, peas, nuts, pork, and beef. Thiamine deficiency causes beriberi. Thiamine is also used to prevent peripheral neuritis associated with pellagra and pregnancy. This vitamin is also beneficial in treating metabolic disorders associated with subacute necrotizing encephalomyelopathy, branched-chain aminoacidopathy, and lactic acidosis associated with pyruvate carboxylase deficiency. Thiamine is considered a standard agent in the treatment of a member with undiagnosed coma.

Thiamine is converted to the active coenzyme thiamine pyrophosphate by the enzyme thiamine diphosphokinase. Thiamine pyrophosphate functions in carbohydrate metabolism in decarboxylation of alpha-keto acids and in the hexose monophosphate shunt. Doses beyond those needed to perform these functions have no known pharmacological effects

Thiamine was approved by the FDA at its inception in 1938.

POSITION STATEMENT:

Thiamine HCI injection is considered medically necessary for treatment of the following conditions and the dose does not exceed 1000 mg:

• Acute alcohol withdrawal syndrome

Beriberi

• Coma

Thiamine responsive maple syrup urine disease (MSUD)

• Peripheral neuritis in pregnancy

Thiamine deficiency

• Severe vomiting of pregnancy

Wernicke’s disease

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Acute alcohol withdrawal syndrome: up to 100mg

Beriberi: 60 mg per day.

Coma: 100mg at presentation.

Maple syrup urine disease (MUSA): up to 1000 mg per day.

Peripheral neuritis in pregnancy – Severe vomiting in Pregnancy: up to 10 mg per day.

Thiamine deficiency (treatment and prophylaxis): up to 100 mg per day.

Wernicke’s disease: up to 1000 mg for the first 12 hours, and up to 100 mg per day thereafter.

PRECAUTIONS:

Hypersensitivity reactions: serious hypersensitivity/anaphylactic reactions can occur.

Multiple vitamin deficiency: simple vitamin B1 deficiency is rare, suspect multiple vitamin deficiencies.

BILLING/CODING INFORMATION:

HCPCS Coding

J3411

Injection, thiamine HCl, 100 mg

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

E51.11

dry beriberi

E51.12

wet beriberi

E51.8

other manifestations of thiamine deficiency

E51.9

thiamine deficiency, unspecified

E71.0

Maple-syrup-urine disease

G93.49

other encephalopathy

O26.829

pregnancy related peripheral neuritis, unspecified trimester

O26.821-O26.823

pregnancy related peripheral neuritis, first trimester, second trimester, third trimester

F10.231

alcohol dependence with withdrawal delirium

F10.239

alcohol dependence with withdrawal, unspecified

R40.20

coma

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Beriberi: is a nervous system ailment caused by a deficiency in vitamin B1 (thiamine) in the diet. Symptoms include severe lethargy and fatigue, together with complications affecting the cardiovascular, nervous, muscular, and gastrointestinal systems.

Korsakoff’s syndrome: is a neurological disorder caused by a lack of thiamine (vitamin B1) in the brain. Also called Korsakoff's dementia, Korsakoff's psychosis, or amnesic-confabulatory syndrome). Its onset is linked to chronic alcohol abuse and/or severe malnutrition.

Wernicke's disease: an inflammatory hemorrhagic form of encephalopathy due to thiamine deficiency, usually associated with chronic alcoholism, with paralysis of the eye muscles, diplopia, nystagmus, ataxia, and usually accompanying or followed by Korsakoff's syndrome

Thiamine deficiency: thiamine derivatives and thiamine-dependent enzymes are present in all cells of the body. The nervous system is particularly sensitive to thiamine deficiency, because of its dependence on oxidative metabolism. Thiamine deficiency commonly presents sub-acutely and can lead to metabolic coma and death. A lack of thiamine can be caused by malnutrition, a diet high in thiaminase-rich foods (raw freshwater fish, raw shellfish, ferns) and foods high in anti-thiamine factors (tea, coffee, betel nuts) and by grossly impaired nutritional status associated with chronic diseases, such as alcoholism, gastrointestinal diseases, HIV-AIDS, and persistent vomiting.

Thiamine-responsive MSUD (Maple syrup urine disease): maple syrup urine disease (MSUD) type 1B is an inherited metabolic disorder named for the characteristic maple syrup smell of the affected person’s urine. Worldwide it affects 1 in 185,000 infants. If carefully treated with a low-protein diet, people with MSUD can live fairly normal lives. Thiamine-responsive MSUD is distinct in that people with this form of the disease will respond to large doses of thiamine. One study found that people with thiamine-responsive MSUD have 30 to 40% the normal activity of the BCKAD enzyme. Many people with this form of the disease can tolerate some protein in their diet.

RELATED GUIDELINES:

Vitamin B-12 Injections, 09-J0000-10
Pyridoxine HCl Injection (vitamin B-6), 09-J1000-65

OTHER:

None

REFERENCES:

  1. Clinical Pharmacology, Copyright® 2013 Elsevier. Accessed 02/15/13.
  2. Facts & Comparisons® e Answers. ©2013 Wolters Kluwer Health. Accessed 02/15/13.
  3. Ingenix HCPCS Level II, Expert 2012.
  4. Ingenix ICD-9-CM for Physicians – Volumes 1 & 2, Expert 2012.
  5. Micromedex ® 2.0, ©2013 Truven Health Analytics Inc. Accessed 02/15/13.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 03/13/13.

GUIDELINE UPDATE INFORMATION:

04/15/12

New medical coverage guideline.

04/15/13

No longer reviewed.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 23, 2017: 11:44 AM