Microsoft word - 31 12 limitations prior authorization eff 110106-strike.rtf

Division of Medicaid
State of Mississippi
Revised: X
Date: 06/01/05
Provider Policy Manual
Current:
11/01/06
Section: Pharmacy
Section: 31.12
Pages: 12 7
Subject: Prior Authorization
Cross Reference:

DOM requires prior authorization of certain covered drugs that have been approved by the Food and
Drug Administration (FDA) for specific medical conditions. The approval criteria are recommended by
DOM’s Pharmacy and Therapeutics Committee and are based on information from the FDA,
manufacturers, and medical literature. The prior authorization process is managed through the DOM
Pharmacy Benefits Manager.
Prescription Drugs Requiring Prior Authorization
These prescription drugs were chosen based on the high potential for misuse and/or abuse. Prior
authorization allows DOM to ensure that these prescription drugs are used responsibly and as they are
intended. The following drugs/drug classes require prior authorization:
• Oral Sustained Release Opioid Agonists (brand name only)

Prior Authorization Process
Processes related to prior authorization for prescription drugs must be handled according to the
procedures set forth by the Pharmacy Benefits Manager.
Refer to Section 1.11 Retrospective DUR Information for information related to the Pharmacy Benefits
Manager.

Provider Policy Manual
Pharmacy
Section: 31.12
Page 1 of 7

Actiq (Oral Transmucosal Fentanyl Citrate)
Actiq is indicated for the management of breakthrough cancer pain in patients with malignancies who are
already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, 50 mcg
transdermal fentanyl/ hour, or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates,
Actiq is contraindicated in the management of acute or postoperative pain. This product must not be
used in opioid non-tolerant patients.
The FDA recommends Actiq to be used only in the care of cancer patients and only by oncologists and
pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer
pain.
The appropriate dosing and safety of Actiq in opioid tolerant children with breakthrough cancer pain have
not been established below the age of sixteen (16) years.
DOM covers Actiq when the following criteria are met:
1. Management of breakthrough cancer pain in patients with malignancies who are already receiving
2. Diagnosis of cancer (ICD-9 codes 141.0-208) Actiq is contraindicated for those patients with one or more of the following: • Respiratory depression/ hypoxia/ hypercarbia • Treatment of acute or postoperative pain • Treatment of opioid non-tolerant patients • Use in children below the age of sixteen (16) years Provider Policy Manual
Pharmacy
Section: 31.12
Page 2 of 12

Cox-2 Inhibitors
DOM covers Cox-2 Inhibitors and/or brand name Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) when
the following criteria are met:
1. The beneficiary must have a diagnosis of one of the following: a. Osteoarthritis (OA) b. Rheumatoid Arthritis (RA) c. Degenerative Joint Disease (DJD) d. Systemic Lupus Erythematosus (SLE) e. Other joint related diagnosis f. 2. The beneficiary must have received and failed to adequately respond to a 30-day trial of each of two prior NSAIDS or COX-2 within the past 6 month period prior. (May be generic, OTC, or brand name.) 3. For Cox-2 Inhibitors, the beneficiary must not have a documented diagnosis of one of the a. GI ulcer disease b. GERD c. Diverticulitis d. Anticoagulation therapy e. Other diagnosis in which bleeding could occur with NSAID therapy NOTE: Generic and DOM covered over-the-counter products in these classes do not require prior authorization. Provider Policy Manual
Pharmacy
Section: 31.12
Page 3 of 12

Enteral Nutrition
Enteral nutrition is used as a nutritional replacement for patients who are unable to get enough nutrients
in their diet. These formulas are taken by mouth or through a feeding tube and are used by the body for
energy and to form substances needed for normal body functions.
DOM covers enteral nutrition when the following criteria are met:
1. For beneficiaries age 21 and over, the requested enteral nutritional must be the sole source of 2. For beneficiaries under the age of 21, specialized feeding must constitute more than 50% of nutritional needs. A qualifying diagnosis is required. 3. The unique composition of the formula must contain nutrients the beneficiary is unable to obtain 4. The composition of the formula must represent an integral part of treatment of the specified 5. It must be documented that the beneficiary is unable to tolerate nutrients orally to sufficiently maintain life. The beneficiary is either unable to take oral nutrition or unable to tolerate oral intake. 6. Consideration is not given to accommodate psychological or behavioral conditions, food preferences, allergies, loss of appetite, or non-compliance with a specialized diet. Documentation to support coverage of enteral nutrition must be maintained in the beneficiary’s medical record. Documentation must include the following: a. Specific diagnosis related to the beneficiary’s inability to take or eat regular food b. For oral feedings, list economic alternatives that have been tried. For beneficiaries age 21 and over, also list laboratory values for albumin or total protein. c. Amount needed per day d. Duration of treatment e. Height, current weight, and recent weight loss f. Specific prescription identifying levels of individual nutrient(s) that is required in increased or restricted amounts. A prior authorization for enteral nutrition is for the nutritional product only and does not include supplies necessary to administer the nutrient. Please note that Medicare must be billed first if the beneficiary is dually-eligible for Medicare and Medicaid. Enteral nutritional replacements are not covered for residents in a long-term care facility, i.e. nursing home, ICF MR, etc. as these products are included in facilities’ per diem rate. Provider Policy Manual
Pharmacy
Section: 31.12
Page 4 of 12

Etanercept/Enbrel

DOM covers Etanercept/Enbrel when the following criteria are met on the initial request:
1. The beneficiary has a diagnosis of Rheumatoid Arthritis (RA). 2. The beneficiary has failed trials of at least one NSAID and one local/oral steroid without success. 3. The beneficiary has failed a trial of a least one prior DMARD and is currently on or has failed the
DOM covers Etanercept/Enbrel for renewal requests with documentation of demonstrated effectiveness.
Provider Policy Manual
Pharmacy
Section: 31.12
Page 5 of 12

Erectile Dysfunction Oral Agents

DOM covers erectile dysfunction oral agents when the following criteria are met:
1. The beneficiary must be male and 21 or older. 2. The beneficiary must be male from birth. 3. The beneficiary must have a diagnosis of one of the following: a. Spinal Cord injury b. Diabetic neuropathy c. Prostatectomy d. Irreversible neurological damage due to TURP e. Cardiovascular disease (CHD,PVD,HTN) 4. The beneficiary must not be receiving nitrates, in any form, or other drugs contraindicated with recommended oral erectile dysfunction treatment. Coverage is limited to one prescription of no more than two units, total, per month for this entire drug category. Provider Policy Manual
Pharmacy
Section: 31.12
Page 6 of 12

Immunosuppressants
DOM covers immunosuppressants when the following criteria are met:
1. The beneficiary must have a diagnosis of one of the following: a. Kidney, liver or heart allogenic transplant b. Rheumatoid 2. Documentation must reflect that blood levels are monitored regularly. The FDA recommends that the prescriber be experienced in managing post-transplant patients on immunosuppressant therapy. Please note that Medicare must be billed first if the beneficiary is dually-eligible for Medicare and Medicaid. Provider Policy Manual
Pharmacy
Section: 31.12
Page 7 of 12

Neurontin
DOM covers Neurontin when the following criteria are met:
1. The beneficiary must have a diagnosis of: • Diabetic Neuropathy of the lower extremities* • Treatment of Amyotrophic Lateral Sclerosis, (ALS)** * Supported by several comparative clinical trials ** Granted orphan drug status by the FDA 2. Corresponding clinical information must be in beneficiary’s medical chart and be retrievable. Generic gabapentin is exempt from prior authorization.
Approval may be granted for up to six months.




Provider Policy Manual
Pharmacy
Section: 31.12
Page 8 of 12

Oral Sustained Release Opioid Agonists (Brand name only)
Patients appropriate for oral sustained release (SR) opioid agonists have chronic, severe pain that has
not responded to alternative pain management choices, such as schedule II opioid agonists, physical
therapy, cognitive behavioral techniques and/or medical techniques.
DOM covers oral SR opioid agents when the following criteria are met:
1. The beneficiary must have a diagnosis of one of the following: a. Cancer (ICD-9 codes 141.0-208) b. Arthropathies (ICD-9 codes 715.01-715.9) c. Spinal neurological disorders (ICD-9 codes 720-725) d. Other ICD-9 codes with supporting documentation 2. If the beneficiary does not have a diagnosis noted above, the prescriber must provide additional medical justification for the absence of alternative therapies in debilitated patients. 3. The beneficiary must have no contraindications such as: a. Hypersensitivity to opiates b. Respiratory depression/ hypoxia/hypercarbia c. Severe asthma or COPD d. Paralytic The daily dosage intervals of oral sustained-release opioid agonists should not exceed manufacturer guidelines or FDA requirements. For opioid dependent patients, the prescriber must provide documentation of a titration-weaning schedule. Provider Policy Manual
Pharmacy
Section: 31.12
Page 9 of 12

Proton Pump Inhibitors
DOM covers proton pump inhibitors also known as anti-secretory therapy when the following criteria are
met:
1. The beneficiary must have a diagnosis of one of the following: a. Heartburn b. H. Pylori c. Gastroesophageal Reflux Disease (GERD) d. Esophagitis e. Peptic Ulcer Disease (PUD) f. g. Barrett’s Esophagus h. Zollinger-Ellison Syndrome i. Other Hypersecretory condition (diagnosis with medical justification attached to the request) 2. The beneficiary must have failed two (2) 30-day trials of Antacids, H2 Antagonists, or other PPI. Multiple antacids will be considered as one trial only. 3. The beneficiary must have documentation of testing supporting the diagnosis. NOTE: DOM covered over-the-counter products in this class do not require prior authorization. Provider Policy Manual
Pharmacy
Section: 31.12
Page 10 of 12

Palvizumab (Synagis)
DOM covers Synagis when a beneficiary meets the criteria in one of the four following categories:
Category 1
< 6 months at the start of Respiratory Syncytial Virus (RSV) Season Diagnosis: Chronic Lung Disease (CLD) and ongoing medical treatment for CLD (supplemental oxygen, steroids, bronchodilators or diuretics) within the last 6 months Age: Birth- 6 months old during RSV season Risk factors as noted below are present and documented
Extending beyond age two years may be considered on an individual basis when supported by clinical
documentation of extreme necessity.
Prior authorization will end at age two (last day of child’s birthday month).
Prior authorization is granted during RSV season only (usually October through March).
RSV Risk Factors:
One of the following is considered sufficient:
• Hemodynamically significant Congenital Heart Disease ( simple, small Atrial Septal Defects (ASD), Ventricular Septal Defects (VSD), and Patent Ductus Arteriosus (PDA) are not eligible). • Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) Or

Must have two of the following:
• Exposure to tobacco smoke in the home Provider Policy Manual
Pharmacy
Section: 31.12
Page 11 of 12

Xenical

DOM covers Xenical when the following criteria are met:
1. A beneficiary must be at least 21 years of age. 2. For the initial request, a beneficiary must have all of the following criteria: a. A diagnosis of diabetes, hypertension, or hyperlipidemia b. A Body Mass Index (BMI) of 35 or greater c. Documentation in medical record of prior physician supervised exercise/diet regimen d. Has planned adjunctive therapy e. Has been educated and understands risks/adverse reaction/complications f. Have no contraindications such as Chronic Malabsorption Syndrome, Hypothyroidism, Cholestasis, or Hypersensitivity to Xenical or to any of its components. 1st renewal request, the beneficiary must have documentation of 7% body weight or greater 4. For subsequent renewals, the beneficiary must have documentation of no weight gain. Provider Policy Manual
Pharmacy
Section: 31.12
Page 12 of 12
Division of Medicaid
State of Mississippi
Revised: X
Date: 07/01/05
Provider Policy Manual
Current:
11/01/06
Section: Pharmacy
Section: 31.13
Pages: 1 3
Subject: Over the Counter (OTC) Drugs
Cross Reference:
DOM covers selected over-the-counter (OTC) drugs pursuant to a legal prescription in writing or verbal order. Only those OTC products manufactured by companies who participate in the Federal Drug Rebate Program are covered. Prescribing of these OTC drugs is strongly encouraged whenever appropriate. Acetaminophen- Drops, liquid, Suppositories Insulin Al & Mg Hydroxide- Tabs & Suspension Al & Mg Hydroxide/ Simeth.- Tabs & Suspension Loratadine (Alavert) Tabs, ODT, 12 hr, Syrup Mag. Gluc. 500 mg, Mag. Cl.Sr. 64 mg Tab Aspirin Tabs- 81 & 325 mg (Buff/ Chew, E.C.) Benzoyl Peroxide Gel- 5% & 10% Miconazole Brompheniramine/Pseudo Liquid & Tabs Naphazoline/Pheniramine Niacin Tabs & Caps- 50,100,125,250,400,500mg Calcium Carbonate- 500 mg Tabs, Suspension Powder (Dialysis Pts. Only)* Omeprazol OTC 20 mg (Prilosec) Oral Electrolyte Mixtures (compares to Pedialyte) Clotrimazole 1 % Topical- Cream & Soln. Clotrimazole Vaginal Cream 1% & 2% Prenatal Dexbrompheniramine/Pseud 6/120 mg Tabs Pseudoephedrine- Drops, Liquid & Tabs Dextromethorphan Polystirex 30/5 ml Suspension Dextromethorphan/Pseud Drops & Syrup Diphenhydramine Caps- 25 & 50 mg & Liq. Ferrous Sulfate-Drops,Liquid,325 mg Tabs, Slow Guaifenesin Syrup- AC, DAC, DM, Plain Triprolidine/ DOM may not cover all available package sizes. Provider Policy Manual
Pharmacy
Section: 31.13
Page 1 of 4

DOM covers selected over-the-counter (OTC) drugs pursuant to a legal prescription in
writing or verbal order. Only those OTC products manufactured by companies who
participate in the Federal Drug Rebate Program are covered.

Prescribing of these OTC drugs is strongly encouraged whenever appropriate.
Generic Name
Strength
Common Brand Name
Dosage Form
Denote on prescription for dialysis pt. Calcium Carbonate (Dialysis Pts. Only)* Denote on prescription for dialysis pt. Chlorpheniramine 2mg/5ml Dexbrompheniramine/Pseudoephrine 6/120mg Provider Policy Manual
Pharmacy
Section: 31.13
Page 2 of 4
Generic Name
Strength
Common Brand Name
Dosage Form
Denote on prescription for pregnant pt. ** Pseudophedrine 15mg/5ml Provider Policy Manual
Pharmacy
Section: 31.13
Page 3 of 4
Generic Name
Strength
Common Brand name
Dosage Form
Renal Vitamins (Dialysis Pts. Only)* Various Tablet Denote on prescription for dialysis pt. Tears Opthalmic Drops *For dialysis patients only, document “FOR DIALYSIS PT.” on the front of the prescription. **For pregnant patients only, document “FOR PREGNANT PT.” on the front of the prescription. Drugs which are available over-the-counter (OTC) shall not be billed to DOM with the NDC for the legend product. NDCs of the legend product that remain covered will be subject to PA and POS requirements. Charges to Medicaid shall be no more than what is charged to the general public for retail sale. DOM reimbursement to providers may be based on the unit price represented by the largest package size if significant cost savings would be realized. Provider Policy Manual
Pharmacy
Section: 31.13
Page 4 of 4
Division of Medicaid
State of Mississippi
Revised: X
Date: 02/01/04
Provider Policy Manual
Current:
11/01/06
Section: Pharmacy
Section: 31.15
Subject: Tobacco Cessation
Cross Reference:

Tobacco Cessation Medications
The following types of tobacco cessation medications will be covered in the Mississippi Medicaid
program:
• Legend or prescription nicotine replacement products A physician’s prescription will be required for all legend and over-the-counter tobacco cessation
medications. Each prescription will count toward the monthly limit.
DOM is authorizing authorizes benefits for tobacco cessation medications for the purpose of supporting
beneficiaries who are trying to quit tobacco use with the temporary assistance of nicotine replacement
therapy. and/or Zyban®. It is expected that utilization of these products will be in accordance with medical
standards of practice, FDA guidelines, and manufacturers’ recommendations which generally limit
product use to approximately 12 weeks. DOM will monitor the beneficiary’s utilization of tobacco
cessation products for over utilization or misuse, and in instances where there are patterns suggesting
over utilization or misuse, the prescribing physician(s) will be contacted for justification of medical
necessity.
Tobacco Cessation Counseling

To maximize the effectiveness of tobacco cessation medications, the Mississippi Tobacco Quitline offers
free telephone counseling through a statewide toll-free telephone number (1-877-4US2ACT).
Provider Policy Manual
Pharmacy
Section: 31.15
Page 1 of 1
Division of Medicaid
State of Mississippi
Revised: X
Date: 06/01/05
Provider Policy Manual
Current:
11/01/06
Section: Pharmacy
Section: 31.24
Subject: Preferred Drug List
Cross Reference:

The Preferred Drug List (PDL) is a list of drugs, which have been reviewed by a committee of physicians,
pharmacists and nurse practitioners referred to as the Pharmacy and Therapeutics (P&T) Committee. and
proposed by the Pharmacy and Therapeutics (P&T) Committee, a group of physicians, pharmacists,
nurse practitioners, and/or health care professionals. Final approval is the responsibility of the Executive
Director of the Division of Medicaid. The Division of Medicaid (DOM) recommends that prescribers use
the drugs on the PDL list.
The preferred drug list contains a wide range of generic and preferred brand name products that have
been approved by the FDA. A medication becomes a preferred drug based first on safety and efficacy,
then on cost-effectiveness. Drugs on the PDL are as effective as non-preferred drugs, but offer economic
benefits for beneficiaries and the State of Mississippi.
The Mississippi Medicaid Preferred Drug List is subject to change. Refer to the Pharmacy Services page
on the DOM website at www.dom.state.ms.us for a current listing of prescription drugs on the PDL.
The Division of Medicaid shall not reimburse for brand name drugs if there are equally effective generic
equivalents available, and the generic equivalents are the least expensive.
The Mississippi Medicaid Preferred Drug List is subject to change. The list will be updated as generic
drugs are introduced that are alternatives to preferred brand name drugs and substitute them for the
brand name drug on the PDL, as necessary. Therefore, when a brand name drug included on the PDL
becomes available generically, the generic equivalent(s) will replace brand name drugs. Brand name
drugs will not be included on the PDL when generic equivalents and products are available at a generic
price. If the manufacturer discontinues a drug, it will be removed from the PDL.
Preferred Drug List Exceptions
The DOM has authorized the Pharmacy Benefits Manager to approve drugs outside the PDL if when one
of the following prior authorization criteria are satisfied:
1) Beneficiary must have used the preferred agents for at least a thirty (30) 30 day course of treatment per drug each and failed trials, within six (6) months prior to requesting the PA and there is documentation of therapeutic failure of preferred drugs, or 2) Documentation of therapeutic failure of preferred drugs, or Adverse event(s) reaction(s) to 3) Documentation of stable therapy as reflected in ninety (90) days of paid Medicaid claims. Contraindications to preferred agent(s), i.e. drug interaction, existing medical condition preventing Drugs must be prescribed and dispensed in accordance with medically excepted indications for uses and dosages. No payment may be made under the Medicaid program for services, procedures, supplies or drugs which are still in clinical trials and/or investigative or experimental in nature. Exceptions to the criteria may be considered if there is sufficient documentation of stable therapy as reflected in 90 days of paid Medicaid claims. Provider Policy Manual
Pharmacy
Section: 31.24
Page 1 of 2

PDL exception request will be reviewed and a determination notice provided within 24 hours from receipt
of request by telephone or other telecommunications device. In emergency situations, the Division will
allow payment for a 72-hour supply of drugs that are to be authorized.
Refer to the Pharmacy Services page on the DOM website @ www.dom.state.ms.us for a Preferred
Drug List Exception Request Form.
Approval will not be granted for non-FDA approved indications. No payment may be made under
the Medicaid program for services, procedures, supplies or drugs which are still in clinical trials
and/or investigative or experimental in nature.

Criteria Exceptions
Exceptions to the PDL criteria may be considered by the Pharmacy Benefits Manager if there is sufficient
documentation of:
• Adverse event(s) reactions(s) to preferred agents or • Therapeutic failure(s) of preferred agents or • Contraindications to preferred agent(s) i.e. drug interaction, existing medical condition preventing the use of preferred agent(s).
Refer to the Pharmacy Services page on the DOM website @ www.dom.state.ms.us for a Preferred
Drug List Exception Request Form.
Provider Policy Manual
Pharmacy
Section: 31.24
Page 2 of 2

Source: http://www.mshistoricalsociety.org/arrec/digital_archives/s34/pdf/784.pdf