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Criteria Chapter 10.1
Criteria for Authorization of Drugs and Medical Supplies

Authorization is not required for payment of a drug or medical supply when the item is:

1. Listed in the Medi-Cal Drug Formulary or Medical Supply Sections 59999 or 59998, specifically matches the applicable description, and is provided in accordance with condition(s) set forth therein; or is

2. Administered to a patient as a part of a physician's, dentist's, or podiatrist's service and is billed to the program in conjunction with that service; or is

3. Provided under the "Emergency Services" provisions of Section 51056; or is

4. Provided to acute hospital care patients at the time of discharge, in quantities not exceeding a tend days' supply and the charges for the item are incorporated in the hospital's claim for the beneficiary's inpatient services.

Authorization is required for a drug or medical supply when the item:

1. Is not listed in the Formulary under Sections 59999 or 59998; or

2. Is listed but it does not clearly match the applicable Formulary description, or is intended to be provided to a beneficiary under conditions other than specified therein, or is requested (as applicable) for a beneficiary who has been placed on partial or fully restricted drug benefits status; or

3. Has a higher cost that the Federal Allowable Cost or Maximum Allowable Ingredient Cost and full reimbursement is desired by the provider.

Authorization cannot be granted for any item specifically excluded from program coverage.

Authorization Guidelines

I Basis of Approval

II. Clinical and Drug Information From the Provider

III. Processing Standards

IV. Types of Items Which May Be Authorized and Applicable Guidelines

V. Items Excluded From Coverage

I. General Basis for Approval of Treatment Authorization Requests (TARs)

A. Approval of a request may be granted when the information submitted by the provider is complete and a determination is made that:

1. The item is medically necessary and there is no suitable alternative listed on the Formulary and no lower cost non-Formulary choice, and it is clinically compatible with the patient's medical condition as well as other drugs or medical supplies being use by the patient, or

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2. The clinical condition of the patient requires override of a Formulary specified coverage restriction, Maximum Allowable Ingredient Cost/Federal Allowable Cost (MAIC/FAC) price level, or

3. Approval of the request will result in less costly treatment than would otherwise occur.

II. Clinical and Drug Information From the Provider

A. Diagnosis
A diagnosis and related clinical information which support the request must be submitted by the provider.

B. Strength and quantity of the item requested.
The strength and quantity of the item requested must be specified, and the number of refills, if any.

C. Directions for use.
Specific directions for use must be given. For example, "Take as directed" or "Take one as necessary" are ambiguous and not acceptable.

D. Brands.
On request for approval of a multiple source item, the brand to be dispensed must be specified.

 III. Processing Standards
A. Clinical information submitted with the request must be comprehensive enough to make a determination that approval of the request is medically and/or cost justified.

B. When appropriate, an explanation should be included indicating what alternatives not requiring authorization have been considered or tried and why there were not usable.

C. Laboratory data (biochemical, radiological, culture/sensitivity, etc.), to support a request will be required when appropriate.

D. The provider should offer an explanation of the anticipated duration of need of the item, and:
1. The quantity requested should be granted if it is in accordance with the beneficiary's clinical need and the chronicity of the condition. The authorized quantity will be adjusted when the requested quantity is not appropriate.
2. Up to (but not more than) a 100 calendar day supply may e authorized for each prescription dispensed.

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3. Refills may be granted for up to a maximum of one year when the use of the item, as authorized, is clearly expected to continue unmodified for up to or beyond one year.

E. Only the lowest cost brand of any multiple source item carried in the pharmacy provider's stock that meets the clinical need of the beneficiary may be authorized. The brand approved must be specified on the TAR. When an MAIC or FAC is applicable, a higher cost brand may only be approved as provided below under IV.B.1.

F. Any item designated either preliminary or final "ineffective" or "Safety" issue rating by the Food and Drug Administration (FDA), should only be authorized when the prescriber provides the consultant verbal or written assurance that there is no suitable alternative rated safe and effective, on or off the Formulary, which will meet the patient's need.

Similar cautious attention should be give to approval of an item rated "Possibly" or "Probably" effective/safe for the intended clinical use of the patient for whom requested.

G. Authorization is required for use of a listed dosage form of a drug by a different route of administration and may be granted as provided below under IV.C.3 and 4.

H. Authorization is required for a listed drug when prepared by the provider in an unlisted (FDA approved) dosage form or dosage strength for use by the same route of administration. The provider's claim is payable without a TAR by use of the appropriate four-digit numerical code plus the letter Z (e.g., 0000Z).

I. Authorization cannot be granted for override of bulk package or direct price Estimate Acquisition Cost (EAC) reimbursement limits specified under Sections 51513 (a) (10) and 51513.5.

IV. Items Which May Be Authorized and Applicable Guidelines

A. Drugs and medical supplies not listed in Section 59999 or 59998 and not excluded from coverage.

B. Prescriptions which do not meet specific price and dispensing limitations applicable to certain Formulary drugs and medical supplies. These include:

1. A product of higher cost that the FAC or MAIC limit, in accordance with the procedural requirements set for in Section 51513 (a) (14).

2. Prescription quantities less than:
a. One hundred tables/capsules of designated drugs specified under the provisions of Section 51513 (b) (2).
b. Three cycle quantities of oral contraceptives specified under the provisions of Section 51513 (b) (4).
c. 480 cc quantities of Theophylline and Potassium supplement liquids specified under the provisions of Section 51513 (b) (5).

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3. Fourth and subsequent prescriptions in any 75-day period for designated drugs subject to the 3 prescriptions in 75 days limitation specified under the provisions of Section 51513 (b) (3).

4. Prescription quantities more than the maximums specified in the Formulary for codeine combination drugs and hypnotic drugs.

C. Exceptions to Formulary condition(s) of use. For example, approval of payment for:
1. Influenza vaccine for immunization of home or community care patients (except when administered by a physician in which case the charge for the vaccine is billed by the physician)
2. Baclofen for FDA approval treatment of conditions other than spasticity resulting from multiple sclerosis or spinal cord injury as specified under the Formulary entry.,
3. Use of listed dosage form of a drug for a different (FDA approved) route of administration.
4. Preparation by the provider of an unlisted dosage form of a listed drug, for use by a different (FDA approved) route of administration.

D. Liquid Sorbitol when used for the prevention or treatment of constipation due to the administration of Sodium Polystyrene Sulfonate to patients (except skilled nursing facilities/intermediate care facilities [SNFs/ICFs] patients) with end-stage renal disease.

E. Localized ganglionic stimulating laxative suppositories for patients (except SNF/ICF inpatients) medically diagnosed with paraplegia or quadriplegia; multiple sclerosis; poliomyelitis, ganglionic blockage processes occurring in the spinal nerve pathways or affecting the lumbrosacral autonomic nervous system pathways related to bowel motility when the disease affects bowel motility.

F. Formulary items for a beneficiary whose drug program benefits have been placed on restriction because the beneficiary has been found to be abusing those benefits.

G. Unlabeled uses.
Unlabeled use of drugs or medical supplies means the use of already marketed item for a clinical indication not listed in the approved labeling of the item by the federal food an Drug Administration (See Title XXII, Section 51056.2).

Prior authorization for unlabeled use of items may be given when the requested unlabeled use represents reasonable and current prescribing practice. The determination of reasonable and current prescribing practice should be based on reference to current medical literature and consultation with provider organizations, academic and professional specialists [see Title XXII, Section 51313 (c) (4)] For this purpose, sources of input may include but not limited to professional organizations such as the American Medical Association (AMA), California Medical Association (CMA), medical/surgical specialty organizations, and reference to current medical literature such a AMA Drug Evaluations, Current Therapy, Drugs of Choice, The Pharmacological Basis of Therapeutics, Harrison's Principles of Internal Medicine, Textbook of Medicine, the Medical Letter, Rational Drug Therapy, J.A.M.A., Clinical Pharmacology and Therapeutics.

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The procedure for handling requests for authorization of commercially available items prescribed for unlabeled uses are as follows:

1. The request is referred to the Field Services Supervising Pharmacist or his designee.

2. The Field Services Supervising Pharmacist, if necessary, in consultation with Benefits Branch Consulting Pharmacists, will review the request and make the TAR determination.

Prior to referring those TARs, the consultant receiving the request should obtain from the provider reasonable documentation or references to support the intended use of the item is accepted as safe and effective for general use by the medical community. However when an unlabeled use of an item has been previously document by the field office as safe and effective for general use, additional data from providers should not be required unless deemed justifiably necessary because of the nature of the particular request.

H. Nutritional supplements or replacements may b authorized except for patients in SNF/ICF if used as a therapeutic regimen to prevent serious disability or death in patients with medically diagnosed conditions that preclude the full use of regular foodstuffs.

V. Items Excluded From Coverage

A. Supplies not primarily medical in nature such as toothbrushes, toothpaste, denture cleaner, shaving soaps and lotions, cigarettes, cigars, pipes and tobacco, cosmetics, hair combs and bushes, tissue wipes.

B. Common household remedies which are frequently and usually purchased for self use by the public in general for self treatment of bodily disease or ailments generally not requiring diagnosis and treatment by a licensed practitioner.

C. Benzoic and Salicylic acid ointment (precompounded), Salicylic acid cream or ointment, Salicylic acid liquid, Sodium Chloride tables 1gm and 2.5 gm, Zinc Oxide paste, nonlegend analgesics except those listed in Section 59999 (c) of the Formulary.

D. Laxatives and agents affecting fecal consistency, except by prior authorization in certain clinical situations as specified above under IV. D and E.

E. Nutritional supplements or replacements, except by prior authorization in certain clinical situations as specified above under IV.H.

F. Vitamin combinations for persons after their fifth birthday.

G. Any drug or medical supply used experimentally [see Title 22, Sections 51056.1 (a) (c) and 51303 (g)] or used investigationally [see Title 22, Section 51056.1 (b) (c) and Section 51303 (h) for exceptions]

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H. Certain items for SNF/ICF inpatients, which are commonly used in providing skilled nursing care, and therefore, must be furnished by the facility under the provisions of Section 51510 and 51511. These items include nonlegend analgesics [in addition to those listed in Section 59999(c) of the Formulary], laxatives (including stool softeners), lubricants, rubbing compounds, antiseptics, *first aid supplies, **hypodermic syringes (and needles), nutritional supplements and replacements, Sodium Chloride irrigating solution, rubber goods such as rectal tubes, catheters, gavage tubing, soft restraints, incontinence pads, urine bags, colostomy or ileostomy pouches and accessories, gauze dressing, thermometers, tongue depressors, applicators, bedside utensils (such as bedpans, basins, irrigating cans, and drinking tubes), and any other supplies commonly used in providing SNF/ICF Care.

Also exclude are those items listed in Section 59998 which are not preceded by a double asterisk (**) or any other item which is not required and prescribed for a specific inpatient for his or her exclusive use.

I. Any item not prescribed by a licenses physician, dentist, or podiatrist.

J. Quantities exceeding a 100 calendar day supply.

K. Incontinence supplies for persons up to the fifth birthday.

L. Sanitary napkins and tampons for normal hygiene associated with menstruation.

M. Cotton, adhesive tapes, and elastic bandages.

* Antiseptic means any preparation containing an antimicrobial substance (except those listed in Drug Formulary and Medical Supply, Sections 59999 59998, and not specifically excluded form SNF/ICF coverage) to be used for local, oral, or topical application to broken or unbroken tissue as a cleanser or protectant to reduce the number of bacteria or minimize the potential for infection. However, when such preparation is uniquely prescribed for a specific patient as the primary modality of treatment of a serious infection for which is labeled safe and effective, it may be authorized when neither it nor a a suitable alternative is available from the facilities; floor stock. Antiseptic preparations include but are not limited to: alcohols (e.g., isopropyl or ethyl alcohol; acids (e.g., acetic acid, boric acid); surface active agents (e.g., quatemary ammonium compounds such a benzalkonium chloride, cetyl pyridinium chloride); phenol (e.g., hexachlorophene); halogenated compounds (e.g., iodine, iodophors, sodium hypochlorite); heavy metal (e.g., mercurials); oxidizing agents (e.g., peroxides); or other preparations containing substances similar in chemical structure or clinical uses.

** First aid supplies mean any article or remedy commonly used for the immediate or minor treatment of cuts, burns, fractures, bleeding, poisoning, other conditions in cases of accident or sudden illness. In addition to items listed in Section 51510 and 51511, and other items intended for the same purpose, first aid supplies include: absorbent cotton, cotton balls and buds, sterile rolls and pads of gauze, muslin and elastic bandages, disposable fabric tissues and underpads, eye pads, sponges, tissues and towels, plaster of paris, adhesive plaster, adhesive elastic bandages, arm sling, adhesive strip bandages, needle for splinter removal, cotton tipped swabs, burn ointment, tourniquet, rubbing compounds, ammonia inhalant ampules, salt tables, antiseptic soap, effervescent antacid/analgesics Epsom salts, dry mustard, bicarbonate of soda, universal antidote for poisons, hot water bottles, safety pins, eye cups, leg and arm splints. Note, some first aide items may be identical, related, or similar to those listed in Sections 59999 and 59998 that are specifically excluded from SNF/ICF coverage. Some may also be classified as common household articles or remedies.

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Manual of Criteria, Chapter 10.1, Criteria for Authorization of Drugs and Medical Supplies