CPT CODE J3301 - Kenalog-40 Injection billing Guide - warnings, side effects

CPT CODE J3301 - Kenalog-40 Injection

Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action.

Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

Disputed Code : J3301

NDC# 00003-029-320
Maximum Allowable - $8.678



KENALOG® 40 mg/ml INJECTION (triamcinolone acetonide)

KENALOG-10 INJECTION is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intradermal, intra-articular, and intra-bursal injection and for injection into tendon sheaths. This formulation is not for intravenous, intramuscular, intraocular, epidural or intrathecal
injection.

• Kenalog Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses.


• You need to take it regularly to get the maximum benefit.

• Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.

• Kenalog Injection can cause side effects in some people (read Section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your medicine, but see your doctor straight away.

• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read Section 4 for more information).

• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.

• Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

INDICATIONS AND CLINICAL USE

Intra-articular: For intra-articular or intrabursal administration, and for injections into tendon sheaths, as adjunctive therapy for short-term administration in the following conditions: synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and post-traumatic osteoarthritis.

Intradermal: Intralesional administration is indicated for the treatment of keloids, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata, and localized hypertrophic, infiltrated, inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis).

1. WHAT KENALOG INJECTION IS AND WHAT IT IS USED FOR

The name of this medicine is Kenalog Injection. Each injection contains triamcinolone acetonide 40mg/ml as the active ingredient. Triamcinolone acetonide belongs to a group of medicine called corticosteroids (steroids). Kenalog injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis.
It is also for the treatment of various allergic disorders including asthma, seasonal allergies, blood disorders, hormone problems, rheumatic fever, and problems associated with digestive system, kidneys, lungs or skin.

2. BEFORE YOU ARE GIVEN YOUR MEDICINE

Do not receive Kenalog Injection if:

• You have had an allergic reaction to a similar medicine or any of the ingredients in this medicine. See Section 6 for full list of ingredients

• You are suffering from an infection unless your doctor has also prescribed a treatment for the infection

Kenalog Injection is not recommended for children under 6 years.

You must tell your doctor if:
• You have had any recent infection [including tuberculosis (TB)]
• You have had recent bowel surgery
• You have, or have had a bowel disorder or stomach ulcer
• You have an infection or inflammation of the veins in your legs
• You have had any mental disorders or epilepsy

WARNINGS

Because KENALOG-10 is a suspension, it should not be administered i.v.

Epidural and intrathecal administration of this product should not be used. Reports of serious medical events have been associated with epidural and intrathecal routes of administration. Cases of serious anaphylactic reactions and anaphylactic shock, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

KENALOG-10 is a long-acting preparation, and is not suitable for use in acute situations. Prolonged use of corticosteroids may produce posterior subcapsular cataracts or glaucoma with possible damage to the optic nerve. Prolonged use may also enhance the likelihood of secondary ocular infections

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious effects: tell a doctor straight away

Steroids including Kenalog Injection can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Kenalog Injection:

• Mood changes, mental disorders, feeling dependent on the medicine, trouble sleeping, fits or epilepsy, fainting and dizziness
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone
If you notice any of these problems talk to a doctor straight away.
Serious cases of anaphylactic reactions (i.e. a serious allergic reaction) and anaphylactic shock including death have been reported. If you notice any of the following, contact your doctor immediately:
• Swelling of the face, lips or throat
• Breathing difficulties
• Skin itching, redness or a rash
• As these may be signs of an allergic reaction


Common side effects (may affect up to 1 in 10 people)

• Increased risk of infection
• Injection site reactions
• Headache
• Joint pain
• You have had any kidney, liver or thyroid (gland in the neck) problems as the dose of Kenalog may need to be adjusted
• You have recently suffered from any form of cancer
• You have thin or brittle bones (osteoporosis)
• You have myasthenia gravis (a disease which causes weak muscles)
• You have high blood pressure or heart failure
• You or someone in your family has glaucoma (increased pressure in your eyes).
• You are diabetic as your insulin dose may need to be changed

Check with your doctor first:

• If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Kenalog Injection.

• If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Kenalog Injection.


How to bill J3301 with correct units

J3301 triamcinolone acetonide, (Kenalog-10, Kenalog-40) per 10 mg
Your bottle says Kenalog 40 =40 mg/ml

If you use 0.25 cc 10 mg/40 mg = 1 Unit
If you use 0.5 cc 20 mg/40 mg = 2 Units
If you use 0.75 cc 30 mg/40 mg = 3 Units
If you use 1.0 cc 40 mg/40 mg = 4 Units


How to calculate the NDC units?

Billing the correct number of NDC units for the corresponding HCPCS/CPT codes on your claims is essential. There are two ways to calculate NDC units:

Option 1 – Use Our Online NDC Units Calculator Tool

Contracted providers may access the online NDC Units Calculator Tool for assistance with converting HCPCS or CPT units to NDC units. This user friendly tool is available to payer contracted providers at no cost.

Option 2 – Calculate the NDC Units Manually

If you prefer to calculate the NDC units manually, there are several steps you will need to take. Here is a sample manual calculation

 [Ciprofloxacin IV, NDC 00409-4765-86, 1200 MG (1 day supply)]:

 The amount of the drug to be billed is 1200 MG, which is equal to 6 HCPCS/CPT units.
 The NDC unit of measure for a liquid, solution or suspension is ML; therefore, the amount billed must be converted from MG to ML.

 According to the NDC description for NDC 00409-4765-86, there are 200 MG of ciprofloxacin in 20 ML of solution (200 MG/20 ML).

 Take the amount to be billed (1200 MG) divided by the number of MG in the NDC description (200 MG). 1200 ÷ 200 = 6

 Multiply the result (6) by the number of ML in the NDC description (20 ML) to arrive at the correct number of NDC units to be billed on the claim (120). 6 x 20 ML = 120


When submitting NDCs on my claim, what other information need to include?

When submitting NDCs on professional/ancillary electronic (ANSI 837P) or paper (CMS-1500) claims, you must also include the following related information in order for your claim to be accepted and reviewed for possible benefits at the NDC level: How to submit J Codes with correct Unit.

o   The applicable HCPCS or CPT code

o   Number of HCPCS/CPT units

o   NDC qualifier (N4)

o   NDC unit of measure (UN, ML, GR, F2)

o   Number of NDC units (up to three decimal places)

Note: As a reminder, you also must include your billable charge.


Where to  enter NDC data on electronic claim (ANSI 5010 837P) transactions?

Here are general guidelines for including NDC data in an electronic claim:


Field Name
Field Description
Loop ID
Segment
Product ID Qualifier
Enter N4 in this field
2410
LIN02
National Drug Code
Enter the 11-digit NDC billing format
assigned to the drug administered
2410
LIN03
National Drug Unit Count
Enter the quantity (number of NDC units)
2410
CTP04
Unit or Basis for Measurement
Enter the NDC unit of measure for the
prescription drug given (UN, ML, GR, or F2)
2410
CTP05


Note: The total charge amount for each line of service also must be included for the Monetary Amount in
Loop ID, Segment SV102.


CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Synthetic analogs such as triamcinolone are primarily used for their antiinflammatory effects in disorders of many organ systems.

Kenalog-40 Injection has an extended duration of effect which may be sustained over a period of several weeks. Studies indicate that following a single intramuscular dose of 60 mg to 100 mg of triamcinolone acetonide, adrenal suppression occurs within 24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days. This finding correlates closely with the extended duration of therapeutic action achieved with the drug.

Intramuscular

Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows:

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

CONTRAINDICATIONS

Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

WARNINGS

Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: Neurologic). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

General

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: Pediatric Use).

Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

Because Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is a suspension, it should not be administered intravenously.

Unless a deep intramuscular injection is given, local atrophy is likely to occur. (For recommendations on injection techniques, see DOSAGE AND ADMINISTRATION.) Due to the significantly higher incidence of local atrophy when the material is injected into the deltoid area, this injection site should be avoided in favor of the gluteal area.

Increased dosage of rapidly acting corticosteroids is indicated in patients on  corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Kenalog-40 Injection is a long-acting preparation, and is not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with Kenalog-40 Injection and for a year afterwards.

Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Kenalog-40 Injection, should not be used for the treatment of traumatic brain injury.

Cardio-Renal

Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when they are used in large doses. Dietary salt restriction and potassium supplementation may be necessary (see PRECAUTIONS). All corticosteroids increase calcium excretion.

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex. Adequate studies to demonstrate the safety of Kenalog Injection use by intraturbinal, subconjunctival, sub-Tenons, retrobulbar, and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular  pressure, and visual disturbances including vision loss have been reported withintravitreal administration. Administration of Kenalog Injection intraocularly or into the nasal turbinates is not recommended.

Intraocular injection of corticosteroid formulations containing benzyl alcohol, such as Kenalog Injection, is not recommended because of potential toxicity from the benzyl alcohol.

DOSAGE AND ADMINISTRATION

General

NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).

The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see Dosage section below). However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

GENERAL

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After  withdrawal, Kenalog-40 Injection should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

SYSTEMIC

For systemic therapy, injection should be made deeply into the gluteal muscle (see WARNINGS). For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.

LOCAL

For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid. With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

HOW SUPPLIED

Kenalog®-40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.

40 mg/mL, 1 mL vial NDC 0003-0293-05
40 mg/mL, 5 mL vial NDC 0003-0293-20
40 mg/mL, 10 mL vial NDC 0003-0293-28
Storage Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate. Bristol-Myers Squibb Company
Princeton, NJ 08543 USA Product of Spain

*submit with modifier 78.

* 20610 (Arthrocentesis, aspiration and/or injection) performed in the office during the global period of a joint surgery but on a different, non-operative joint is unrelated and may be separately reported with modifiers 79 and XS.

* A Kenalog injection to the skin graft/flap site following Moh’s surgery and flap repair is related. This service is included in the global surgery package for the original surgery. Do not report with modifier 79, 58, or any other modifier.


* A skin lesion is removed with Mohs surgery and repaired with a skin graft (90-day global period). Three weeks later, a second lesion in the same body area (e.g. nose, forehead) but not touching the first lesion is also removed with Mohs surgery and repaired with an adjacent tissue transfer technique. Treatment of two lesions not which are separate and distinct, not touching, on the same day are subject to multiple surgery reductions. These same two lesions treated on different days is considered unrelated; submit the second surgery with modifier 79.

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