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Section 13 - Benefits and Limitations 1 SECTION 13 - BENEFITS AND LIMITATIONS 13.1 GENERAL INFORMATION ...................................................................................................... 4 13.1.A OMNIBUS RECONCILIATION ACT OF 1990 (OBRA 90) ................................................. 4 13.1.B DRUG COVERAGE UNDER THE MISSOURI MEDICAID PHARMACY PROGRAM... 4 13.2 PROVIDER PARTICIPATION.................................................................................................. 5 13.2.A NON-DISCRIMINATION ..................................................................................................... 5 13.2.B RETENTION OF RECORDS ................................................................................................. 5 13.2.C ADEQUATE DOCUMENTATION ....................................................................................... 6 13.3 PARTICIPANT ELIGIBILITY .................................................................................................. 6 13.3.A RECIPIENT NONLIABILITY ............................................................................................... 6 13.4 DRUG PRODUCTS EXCLUDED FROM THE MISSOURI MEDICAID PHARMACY PROGRAM ................................................................................................................................... 7 13.5 OVER-THE-COUNTER (OTC) DRUG COVERAGE............................................................. 7 13.6 NUTRITIONAL SUPPLEMENTS ............................................................................................. 7 13.7 DRUG PRIOR AUTHORIZATION PROCESS........................................................................ 8 13.7.A SPECIFIC DRUG PRODUCTS AND CATEGORIES REQUIRING PRIOR AUTHORIZATION................................................................................................................ 9 13.7.B PRIOR CONTENTS NO LONGER APPLICABLE .............................................................. 9 13.7.C PRIOR AUTHORIZATION APPROVAL NOTIFICATION ................................................ 9 13.7.D PRIOR CONTENTS NO LONGER APPLICABLE .............................................................. 9 13.7.E CLAIM SUBMISSION FOR PRIOR AUTHORIZED DRUGS............................................. 9 13.7.E(1) Point of Service (POS) Claims Submission .................................................................... 9 13.7.E(2) Paper Claims Submission ............................................................................................... 9 13.7.F 72 HOUR EMERGENCY SUPPLY ..................................................................................... 10 13.8 FEDERAL UPPER LIMITS AND MISSOURI MAXIMUM ALLOWABLE COST (MAC) .......................................................................................................................................... 10 13.9 GENERIC REIMBURSEMENT OVERRIDE PROCEDURE .............................................. 10 13.10 SPECIAL LIMITATIONS......................................................................................................... 11 13.10.A QUANTITY LIMITATIONS ............................................................................................... 11 Pharmacy Manual Last Updated - 06/27/2008 Archived - 05##2012 Archived

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SECTION 13 - BENEFITS AND LIMITATIONS

13.1 GENERAL INFORMATION...................................................................................................... 4

13.1.A OMNIBUS RECONCILIATION ACT OF 1990 (OBRA 90)................................................. 4

13.1.B DRUG COVERAGE UNDER THE MISSOURI MEDICAID PHARMACY PROGRAM... 4

13.2 PROVIDER PARTICIPATION.................................................................................................. 5

13.2.A NON-DISCRIMINATION ..................................................................................................... 5

13.2.B RETENTION OF RECORDS................................................................................................. 5

13.2.C ADEQUATE DOCUMENTATION....................................................................................... 6

13.3 PARTICIPANT ELIGIBILITY .................................................................................................. 6

13.3.A RECIPIENT NONLIABILITY............................................................................................... 6

13.4 DRUG PRODUCTS EXCLUDED FROM THE MISSOURI MEDICAID PHARMACY

PROGRAM ................................................................................................................................... 7

13.5 OVER-THE-COUNTER (OTC) DRUG COVERAGE............................................................. 7

13.6 NUTRITIONAL SUPPLEMENTS ............................................................................................. 7

13.7 DRUG PRIOR AUTHORIZATION PROCESS........................................................................ 8

13.7.A SPECIFIC DRUG PRODUCTS AND CATEGORIES REQUIRING PRIOR

AUTHORIZATION................................................................................................................ 9

13.7.B PRIOR CONTENTS NO LONGER APPLICABLE .............................................................. 9

13.7.C PRIOR AUTHORIZATION APPROVAL NOTIFICATION ................................................ 9

13.7.D PRIOR CONTENTS NO LONGER APPLICABLE .............................................................. 9

13.7.E CLAIM SUBMISSION FOR PRIOR AUTHORIZED DRUGS............................................. 9

13.7.E(1) Point of Service (POS) Claims Submission.................................................................... 9

13.7.E(2) Paper Claims Submission ............................................................................................... 9

13.7.F 72 HOUR EMERGENCY SUPPLY ..................................................................................... 10

13.8 FEDERAL UPPER LIMITS AND MISSOURI MAXIMUM ALLOWABLE COST

(MAC) .......................................................................................................................................... 10

13.9 GENERIC REIMBURSEMENT OVERRIDE PROCEDURE.............................................. 10

13.10 SPECIAL LIMITATIONS......................................................................................................... 11

13.10.A QUANTITY LIMITATIONS ............................................................................................... 11

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13.10.B DOSE OPTIMIZATION....................................................................................................... 11

13.10.C ADMINISTRATIVE CLINICAL EDITS............................................................................. 12

13.10.D STEP THERAPY.................................................................................................................. 12

13.10.E PREFERRED DRUG LIST .................................................................................................. 13

13.10.F PRODUCTS COVERED UNDER THE NURSING HOME PER DIEM............................. 13

13.10.F(1) Personal Care ................................................................................................................ 13

13.10.F(2) Equipment ..................................................................................................................... 14

13.10.F(3) Nursing Care/Patient Care Supplies.............................................................................. 15

13.10.F(4) Therapeutic Agents and Supplies.................................................................................. 16

13.10.G LONG-TERM CARE MAINTENANCE DRUG BILLING ................................................ 16

13.11 RECIPIENT COST SHARING (COPAY, COINSURANCE, SHARED DISPENSING

FEE) ............................................................................................................................................. 16

13.11.A PROVIDER RESPONSIBILITY TO COLLECT SHARED PHARMACY

DISPENSING FEE ............................................................................................................... 17

13.11.B RECIPIENT RESPONSIBILITY TO PAY THE SHARED PHARMACY DISPENSING

FEE AMOUNTS................................................................................................................... 17

13.11.B(1) Exceptions to Shared Pharmacy Dispensing Fee.......................................................... 17

13.11.B(2) Pharmacy Dispensing Fees ........................................................................................... 18

13.11.C RECIPIENT RESPONSIBILITY TO PAY COPAY AMOUNTS ....................................... 18

13.11.C(1) Participants Who are Required to Pay a Copay.............................................................. 18

13.11.C(2) Services Requiring Copay............................................................................................. 18

13.12 MANAGED HEALTH CARE PLAN PHARMACEUTICALS............................................. 19

13.12.A PRIOR AUTHORIZATION ................................................................................................. 20

13.12.B FAMILY PLANNING SERVICES ...................................................................................... 20

13.12.C BEHAVIORAL HEALTH SERVICES ................................................................................ 21

13.13 MANAGED CARE PLAN PROTEASE INHIBITOR CARVE-OUT .................................. 21

13.14 DRUG USE REVIEW (DUR) .................................................................................................... 21

13.14.A PROSPECTIVE DUR........................................................................................................... 21

13.14.A(1) Prospective Drug Use Review (DUR) Through the Electronic Claims Management

(ECM) or Point of Service (POS) System ........................................................................ 22

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13.14.A(2) Patient Counseling ........................................................................................................ 22

13.14.A(3) Documentation of Offer to Counsel.............................................................................. 23

13.14.A(4) Patient Profiles .............................................................................................................. 23

13.14.B RETROSPECTIVE DUR...................................................................................................... 23

13.15 EMERGENCY SERVICES ....................................................................................................... 24

13.16 OUT-OF-STATE, NONEMERGENCY SERVICES .............................................................. 24

13.16.A EXCEPTIONS TO OUT-OF-STATE PRIOR AUTHORIZATION (PA) REQUESTS....... 25

13.17 HOSPICE..................................................................................................................................... 26

13.17.A PHARMACY REIMBURSEMENT..................................................................................... 26

13.18 DIABETES SELF-MANAGEMENT TRAINING .................................................................. 26

13.18.A DIABETES SELF-MANAGEMENT TRAINING ENROLLMENT CRITERIA................ 26

13.18.B DIABETES SELF-MANAGEMENT TRAINING SERVICE LIMITATIONS................... 27

13.18.B(1) Procedure Codes for Diabetes Self-Management Training .......................................... 28

13.18.B(2) Diabetes Self-Management Training Billing Procedures ............................................. 28

13.19 DIABETIC SUPPLIES........................................................................................................... 29

13.20 MISSOURI MEDICAID DISEASE STATE MANAGEMENT PROGRAM................... 29

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SECTION 13-BENEFITS AND LIMITATIONS

13.1 GENERAL INFORMATION

13.1.A OMNIBUS RECONCILIATION ACT OF 1990 (OBRA 90)

The 101st Congress of the United States passed in 1990 the Omnibus Reconciliation Act of 1990 (OBRA 90). OBRA 90 contained language which resulted in significant changes in the provision of pharmaceutical services under state Medicaid programs. The major provisions in this language affected the following areas of the Missouri Medicaid Pharmacy Program:

• The list of covered drugs,

• The mechanism for prior authorization of drugs, and

• Drug Utilization Review (DUR).

OBRA 90 indicates that no federal matching funds are available for expenditures for drugs produced by manufacturers that have not entered into a rebate agreement with the federal Department of Health and Human Services (HHS). With certain permissible exclusions and restrictions, virtually all products of manufacturers that have entered into a rebate agreement with HHS are reimbursable under state Medicaid programs.

13.1.B DRUG COVERAGE UNDER THE MISSOURI MEDICAID PHARMACY PROGRAM

All drug products (with the exception of Drug Efficacy Study Implementation (DESI) drugs and drugs specified in Section 13.4 and Section 13.7), produced by manufacturers that have entered into a rebate agreement with the Federal Government are reimbursable under the Missouri Medicaid Pharmacy Program.

A list of manufacturers that have entered into an agreement with the Federal Government (along with the first five digits of the NDC number by which products may be identified), can be found in Drug Company Contact Information. Products for which the first five digits of NDC numbers are not included on the list are not reimbursable under the Missouri Medicaid Pharmacy Program and are not available through any prior authorization program.

In addition to other information required by the national rebate contract, the federal Centers for Medicare & Medicaid Services (CMS) has required that participating manufacturers identify products which are affected by the Drug Efficacy Study Implementation (DESI). CMS has instructed state Medicaid programs that products so identified are not subject to federal financial participation and are therefore not reimbursable under the Missouri Medicaid Pharmacy Program.

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As rebates are to be paid by manufacturers to the state agency on a National Drug Code (NDC) specific basis, it is essential that providers enter on each claim the precise NDC identifying the product dispensed. A product without an NDC is not reimbursable.

Should a dispute arise between Medicaid utilization data and a manufacturer’s estimation of product sold, data is supplied to the manufacturer to resolve the dispute. If necessary, zip code or provider-specific utilization data is provided. Should data indicate that a provider is billing fraudulently by using NDCs other than those identifying the actual product dispensed, the information is referred to the Medicaid Investigation Unit and may result in legal action, provider sanctions and possible termination from the program.

13.2 PROVIDER PARTICIPATION

To participate in the Missouri Medicaid Pharmacy Program, the pharmacy provider must satisfy the following requirements:

• Have a signed and accepted Participation Agreement in effect with the Missouri Department of Social Services, Division of Medical Services.

Additional information on provider conditions of participation can be found in Section 2 of this provider manual.

13.2.A NON-DISCRIMINATION

Providers must comply with the 1964 Civil Rights Act, as amended; Section 504 of the Rehabilitation Act of 1973; the Age Discrimination Act of 1975; the Omnibus Reconciliation Act of 1981 and the Americans with Disabilities Act of 1990 and all other applicable Federal and State Laws that prohibit discrimination in the delivery of services on the basis of race, color, national origin, age, sex, handicap/disability or religious beliefs.

Further, all parties agree to comply with Title VII of the Civil Rights Act of 1964 which prohibits discrimination in employment on the basis of race, color, national origin, age, sex, handicap/disability, and religious beliefs.

13.2.B RETENTION OF RECORDS

Medicaid providers must retain for 5 years, from the date of service, fiscal and medical records that coincide with and fully document services billed to the Medicaid Agency, and must furnish or make the records available for inspection or audit by the Department of Social Services or its representative upon request. Failure to furnish, reveal and retain adequate documentation for services billed to the Medicaid Program may result in recovery of the payments for those services not adequately documented and may result in sanctions to

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the provider’s participation in the Medicaid Program. This policy continues to apply in the event of the provider’s discontinuance as an actively participating Medicaid provider through change of ownership or any other circumstance.

All prescriptions filled for eligible participants must be filed in accordance with requirements of the Missouri Board of Pharmacy.

13.2.C ADEQUATE DOCUMENTATION

All services provided must be adequately documented in the medical record. The Code of State Regulations, 13 CSR 70-3.030, Section (1)(A) defines “adequate documentation” and “adequate medical records” as follows:

Adequate documentation means documentation from which services rendered and the amount of reimbursement received by a provider can be readily discerned and verified with reasonable certainty.

Adequate medical records are records which are of the type and in a form from which symptoms, conditions, diagnoses, treatments, prognosis and the identity of the patient to which these things relate can be readily discerned and verified with reasonable certainty. All documentation must be made available at the same site at which the service was rendered.

13.3 PARTICIPANT ELIGIBILITY

A participant must be eligible for Medicaid on each date that a service is provided in order for a provider to receive Medicaid reimbursement for those services.

Additional information regarding participant eligibility can be found in Section 1 of this provider manual.

13.3.A RECIPIENT NONLIABILITY

Medicaid covered services rendered to an eligible participant are not billable to the participant if Medicaid would have paid had the provider followed the proper policies and procedures for obtaining payment through the Medicaid Program as set forth in 13 CSR 70-4.030.

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13.4 DRUG PRODUCTS EXCLUDED FROM THE MISSOURI MEDICAID PHARMACY PROGRAM

The pharmacy provisions of OBRA 90 list specific drugs and categories of drugs that state Medicaid programs may exclude from coverage. The specific and up-to-date listing of the drugs and categories of drugs that are excluded from coverage under the Missouri Medicaid Pharmacy Program may be accessed by referencing Drugs with Coverage Limitations.

Pharmacies are encouraged to submit a claim and receive a denial prior to calling the Pharmacy Help Desk.

13.5 OVER-THE-COUNTER (OTC) DRUG COVERAGE

As specified in Section 13.4, some over-the-counter (OTC) products are reimbursable through the Missouri Medicaid Pharmacy Program upon prescription. While OTC preparations generally do not require a prescription for sale to the general public, a prescription for this type of product is required in order for the product to be reimbursable for a Medicaid participant under the Medicaid Program. The specific and up-to-date information on the OTC products may be accessed at OTC Covered Products.

Over-the-counter preparations listed in 13 CSR 70-10.010 continue to be included in the nursing home per diem and should not be billed to the Pharmacy Program. Payment for these products is the responsibility of the nursing home.

13.6 NUTRITIONAL SUPPLEMENTS

Nutritional supplements such as Ensure and Sustacal and infant formulas such as Enfamil and Similac are not reimbursable through the Missouri Medicaid Pharmacy Program. This is due to the federal interpretation that such products are food products rather than drug products and as such are not affected by national rebate agreements.

Nutritional supplements and infant formulas are included in the nursing home per diem.

For children under 21 years of age, all nutritional supplements, infant formulas, related enteral supplies and equipment and supplies and pumps related to intravenous therapy are available only through the Durable Medical Equipment (DME) Program if prior authorized. For persons 21 and over, the above mentioned items are available through the Missouri Medicaid Exception Process with restrictions. Refer to Section 20 for further information.

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13.7 DRUG PRIOR AUTHORIZATION PROCESS

As specified in OBRA 90, any Medicaid drug prior authorization process must meet certain criteria. Such a process must:

• provide a response by telephone or other telecommunication device within 24 hours of a request for prior authorization.

• except with respect to the drugs on the list of drugs permissible for exclusion, provide for the dispensing of at least a 72-hour supply of a covered outpatient drug in an emergency situation.

In accordance with OBRA 90 requirements, patient-specific drug prior authorization requests are accepted and responded to via telephone (800) 392-8030 or by faxing the Drug Prior Authorization form to (573) 636-6470, Monday through Friday, 8:00 a.m. to 5:00 p.m., excluding state holidays and weekends. All requests for drug prior authorization must be initiated by a physician or prescriber with prescribing authority for the drug category for which prior authorization is being requested. All requests must include all required information. Requests received that have sufficient information and are initiated by a physician or other authorized prescriber receive a response either during the requestor’s call or by return FAX or phone call. Requests received with insufficient information for review or received from someone other than a physician or other authorized prescriber do not initiate a prior authorization review or the 24-hour response period.

The following information must be supplied with each patient-specific drug prior authorization (PA) request:

• Participant DCN

• Participant name

• Drug, strength, dosage form and dosing schedule requested

• Diagnosis for which the requested drug is to be used

• Requested duration of approval

• Prescriber's name, address, phone number, fax number (if available) and original signature

In addition, detailed drug/patient information is required to enable a decision to approve prior authorization. Drug or category-specific prior authorization criteria have been developed by the University of Missouri-School of Pharmacy with review and approval by the Drug Prior Authorization Committee and the Division of Medical Services.

Providers are reminded that no prior authorization process exists for products of manufacturers that have not signed the national rebate agreement.

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13.7.A SPECIFIC DRUG PRODUCTS AND CATEGORIES REQUIRING PRIOR AUTHORIZATION

Reference the Drug Prior Authorization Policy for specific and up-to-date information on drug products that require prior authorization (PA) to be reimbursable under the Missouri Medicaid Pharmacy Program. The provider may review the specific policy requirements to expedite processing of requests. These policies are dynamic and are revised as necessary to remain current.

Prior authorization is not granted for uses other than those specified.

13.7.B PRIOR CONTENTS NO LONGER APPLICABLE

13.7.C PRIOR AUTHORIZATION APPROVAL NOTIFICATION

Prescribers are notified of approvals or denials of drug prior authorization requests either during the requestor’s call or by return FAX or phone call. In addition to the approval, the requesting physician is given an approval end date. The approval end date must be communicated to the dispensing pharmacy either on the face of the prescription or verbally. This information should also be recorded in the patient’s chart for future reference. Pharmacies may record this information for this purpose, as well.

Providers may contact the Pharmacy Help Desk at (800) 392-8030 to obtain approval information, as necessary.

13.7.D PRIOR CONTENTS NO LONGER APPLICABLE

13.7.E CLAIM SUBMISSION FOR PRIOR AUTHORIZED DRUGS

13.7.E(1) Point of Service (POS) Claims Submission

Claims may be submitted for prior authorized drugs via the point of service system.

13.7.E(2) Paper Claims Submission

As is true for non-prior authorized products, providers must use the precise national drug code (NDC) of the product dispensed when submitting claims for pharmaceutical services. A product without an NDC is not reimbursable.

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13.7.F 72 HOUR EMERGENCY SUPPLY

OBRA 90 required that prior authorization programs must provide for the dispensing of a 72 hour emergency supply. For these purposes, the dispensing of a 72 hour emergency supply is reimbursable only when dispensed outside of the state office regular working hours, during a weekend or a state holiday.

Each claim for the dispensing of a 72 hour supply must be submitted on paper to: Pharmacy Unit, Division of Medical Services, P.O. Box 6500, Jefferson City, MO 65102-6500. In addition, the following documentation is required to be attached to each claim:

• A copy of the prescription;

• A statement of the circumstances of the emergency.

The intent of this provision is to assure that participants have access to prior authorized drugs when necessary, not to circumvent the prior authorization process. Claims submitted for the dispensing of an emergency supply are tracked and reviewed for possible abuse by participants and providers. If such abuse is detected, appropriate action is taken.

13.8 FEDERAL UPPER LIMITS AND MISSOURI MAXIMUM ALLOWABLE COST (MAC)

The Missouri Medicaid Pharmacy Program includes nearly all products manufactured or distributed by companies that have signed the national rebate agreement and a number of these drugs are subject to a Federal Upper Limit.

Reference the Missouri Maximum Allowable and Federal Upper Cost for Specific Drug Products list.

13.9 GENERIC REIMBURSEMENT OVERRIDE PROCEDURE

The current procedure prescribers must follow to obtain an override to a generic reimbursement limitation (such as the limitations listed in the Missouri Maximum Allowable and Federal Upper Cost for Specific Drug Products listing) in order to allow for reimbursement at a trade name level is as follows:

The prescriber must submit a written Drug Prior Authorization request form by mail to the Pharmacy Unit, P.O. Box 4900, Jefferson City, MO 65102-4900 or by FAX at (573) 636-6470 or via the Drug Prior Authorization Hotline (800) 392-8030. This Drug Prior Authorization must be on behalf of a specific Missouri Medicaid participant and must document whether or not the patient had a trial of a generic product. If the generic product was tried, the result must be documented and a Federal Food

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and Drug Administrative (FDA) MedWatch form must be completed and submitted for review. These forms are available on the Internet at the FDA website. If the generic product was not tried, the medical reason that such a trial is inappropriate in the specific patient’s case must be documented.

13.10 SPECIAL LIMITATIONS

13.10.A QUANTITY LIMITATIONS

There is a 31-day maximum supply restriction on claims submitted for prescriptions dispensed to Missouri Medicaid participants. The following categories are exempt from this restriction:

DRUG OR CATEGORY

MAXIMUM LIMITATION (IF APPLICABLE)

Antiretroviral agents

Contraceptives, oral One year

Drug products limited by packaging requirements

Packaging requirements

Vitamins, Children's 100 days supply

Vitamins, Prenatal 100 days supply

Pharmacy claims submitted for a days supply greater than allowed under this policy are denied. Quantity restrictions, such as for aspirin and acetaminophen, in effect prior to December 1, 2000, effective date of this policy, are removed.

NOTE: Effective December 1, 2000, all spenddown participants are exempt from the Missouri Medicaid 31-day supply maximum restriction on pharmacy services. For questions, contact the Provider Relations Communications Unit at (573) 751-2896.

13.10.B DOSE OPTIMIZATION

Pharmacy claims submitted are subject to edits to identify claims for pharmacy services that fall outside expected patterns of use for certain products. Overrides to these edit denials are processed through a help desk at 800-392-8030. The help desk is available seven days a week, Monday-Friday, 8:00 a.m. to 9 p.m. and Saturday, Sunday and major national holidays 8:00 a.m. to 6:00 p.m. A menu directs callers to select options based on the nature of the call.

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Justification for utilization outside expected patterns, such as FDA approved labeling, are required for approval of such an override.

Reference the Dose Optimization Edit listing for specific and up-to-date information on the Missouri Medicaid Dose Optimization Edit.

13.10.C ADMINISTRATIVE CLINICAL EDITS

Administrative clinical edits are designed to enhance patient care and optimize the use of program funds through appropriate clinical and fiscal use of medications. Point of service pharmacy claims are routed through an automated computer system to apply edits specifically designed to assure effective drug utilization. The edits are based on evidence-based clinical criteria and available nationally recognized peer-reviewed information. Through the clinical editing process, therapy is automatically and transparently approved for patients who meet the system approval criteria. For patients who do not meet the criteria, therapy requires a call from the physician's office or the pharmacy to the Medicaid Pharmacy Help Desk at (800) 392-8030 or the Clinical Edit/Step Therapy Authorization form faxed to (573) 636-6470 to initiate a review and potentially authorize claims. Pharmacist and physician providers with additional information specific to the rejected claim can call the hotline for assistance seven days a week, Monday-Friday, 8:00 a.m. to 9 p.m. and Saturday, Sunday and major national holidays 8:00 a.m. to 6:00 p.m.

Reference the Clinical Edit/Step Therapy documents for up-to-date information on the administrative clinical and fiscal edits. To assist providers in preparing for future change to drug coverage, reference the Clinical/Edit/Step Therapy Proposed Implementation Schedule for scheduling information.

13.10.D STEP THERAPY

The Missouri Medicaid Pharmacy Program, University of Missouri-Kansas City School of Pharmacy Drug Information Center, and the Drug Prior Authorization Committee perform evidence based reviews of specific therapeutic classes of drugs responsible for a significant part of program cost increases. The clinical reviews determine what scientific evidence exists, if any, to support the use of newer products over older therapies in the same therapeutic class in treating specific diseases. Efficacy and safety information from primary literature sources is evaluated and compared along with a pharmacoeconomic analysis, to determine a reference drug from the therapeutic class for a specific diagnosis.

The reference drug(s) becomes the only drug(s) from that class for that diagnosis that may be used at the onset of therapy without prior authorization. Established patients who are adhering to a therapy other than the reference drug are automatically approved to continue the therapy on which they have been stabilized. New patients require a trial on the reference

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drug for a period determined by appropriate drug use parameters. After the trial period, if the reference agent is not effective, the enhanced screening software allows the prescriber to change therapy within the therapeutic class without prior authorization.

If there are unique circumstances that require the most recently available non-reference drug at the onset of therapy, the prescriber can pre-certify that need through the Pharmacy Help Desk. Pre-certification requires the prescribing physician to submit a request for an individual patient by calling the help desk at (800) 392-8030 or by faxing the Clinical Edit/Step Therapy Authorization form to (573)636-6470. The vast majority of claims are electronically screened by drug regimen, diagnosis and medical procedures, with no direct action required by the providers.

Reference the Clinical Edit/Step Therapy documents for up-to-date information on step therapy drugs and reference the Clinical/Edit/Step Therapy Proposed Implementation Schedule for scheduling information.

13.10.E PREFERRED DRUG LIST

In an effort to ensure economic and efficient provision of the Medicaid pharmacy benefit, the Missouri Medicaid Pharmacy Program has implemented a Preferred Drug List (PDL), including supplemental rebates from drug manufacturers. Point of sale pharmacy claims are routed through predetermined criteria standards to review drug therapies prior to payment. These edits are built upon evidence-based clinical criteria and available nationally recognized peer-reviewed information. The list of products included in the clinical editing process continues to evolve as additional products are identified for appropriate clinical and fiscal limitations. As the PDL process is fluid, providers are encouraged to frequently refer to the specific and up-to-date information on the PDL and the system approval criteria may be accessed by referring to the Preferred Drug List.

13.10.F PRODUCTS COVERED UNDER THE NURSING HOME PER DIEM

Products that are reimbursable under the nursing home per diem are not to be billed to Missouri Medicaid by pharmacy providers. These services cannot be billed to the participant. All routine care items are considered included in the Medicaid reimbursement to long term care facilities. Pharmacy providers MUST NOT bill the Medicaid Program or the participant for items or services included on this list. The following is a list of covered services and supplies.

13.10.F(1) Personal Care

Baby powder

Bedside tissues

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Bib, all types

Deodorants

Disposable underpads of all types

Gowns, hospital

Hair care, basic including washing, sets, brushes, combs, non-legend shampoo

Lotion, soap and oil

Oral hygiene including denture care, cups, cleansers, mouthwashes, tooth brushes and paste

Shaves, shaving cream and blades

Nail clipping and cleaning-routine

13.10.F(2) Equipment

Arm slings

Basins

Bathing equipment

Bed frame equipment including trapeze bars and bedrails

Bed pans, all types

Beds, manual, electric

Canes, all types

Crutches, all types

Foot cradles, all types

Glucometers

Heat cradles

Heating pads

Hot pack machines

Hypothermia blanket

Mattresses, all types

Patient lifts, all types

Respiratory equipment: compressors, vaporizers, humidifiers, IPPB machines, nebulizers, suction equipment and related supplies, etc.

Restraints

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Sand bags

Specimen container, cup or bottle

Urinals, male and female

Walkers, all types

Water pitchers

Wheelchairs, standard, geriatric and rollabout

13.10.F(3) Nursing Care/Patient Care Supplies

Catheter, indwelling and non-legend supplies

Decubitus ulcer care: pads, dressings, air mattresses, aquamatic K pads (water heated pads), alternating pressure pads, flotation pads and/or turning frames, heel protectors, donuts and sheepskins

Diabetic blood and urine testing supplies

Douche bags

Drainage sets, bags, tubes, etc.

Dressing trays and dressings of all types

Enema supplies

Gloves, non-sterile and sterile

Ice bags

Incontinency care including pads, diapers and pants

Irrigation trays and non-legend supplies

Medicine droppers

Medicine cups

Needles including but not limited to hypodermic, scalp, vein

Nursing services: regardless of level, administration of oxygen, restorative nursing care, nursing supplies, assistance with eating and massages provided by facility personnel

Nursing supplies: lubricating jelly, betadine, benzoin, peroxide, A & D ointment, tapes, alcohol, alcohol sponges, applicators, dressings, and bandages of all types, cotton balls, and aerosol merthiolate, tongue depressors.

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Ostomy supplies: adhesive, applicant, belts, face plates, flanges, gaskets, irrigation sets, night drains, protective dressing, skin barriers, tail closures and bags

Suture care including trays and removal kits

Syringes, all sizes and types including asepto

Tape for laboratory tests

Urinary drainage tube and bottle

13.10.F(4) Therapeutic Agents and Supplies

Drugs, stock (excluding insulin)

Enteral feedings (including by tube) and all related supplies

I.V. therapy supplies: arm boards, needles, tubing and other related supplies

Oxygen, (portable and stationary), oxygen delivery systems, concentrators and supplies

Special diets

Any and all non-legend antacids, non-legend laxatives, non-legend stool softeners and non-legend vitamins. Providers may not elect which non-legend drugs in any of the four categories to supply; and all must be provided to residents as needed and are included in a facility’s per diem rate.

13.10.G LONG-TERM CARE MAINTENANCE DRUG BILLING

Long-term maintenance and/or therapy drugs are required to be prescribed for no less than a one-month supply when, in the prescriber's professional judgement, the patient's diagnosis has been established, the condition stabilized, and the drug has achieved the desired effect and may be safely prescribed. Pharmacy providers are to dispense in the manner prescribed. Regardless of the dispensing system utilized, long term maintenance medications may be billed no more frequently than one time per month.

13.11 RECIPIENT COST SHARING (COPAY, COINSURANCE, SHARED DISPENSING FEE)

Participants eligible to receive certain Missouri Medicaid services are required to pay a small portion of the cost of the services. This cost sharing amount is referred to as copay, coinsurance, or shared dispensing fee (pharmacy). The cost sharing amount is paid by the participant at the time services are rendered. Services of the Pharmacy Program described in this manual are subject to a cost

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sharing amount. The provider must accept in full the amounts paid by the state agency plus any cost sharing amount required of the participant.

The Pharmacy Program is subject to the cost sharing (shared pharmacy dispensing fee) amount, and a copay amount applies for some participants.

13.11.A PROVIDER RESPONSIBILITY TO COLLECT SHARED PHARMACY DISPENSING FEE

Providers of service must charge and collect the shared pharmacy dispensing fee amount. Providers of service may not deny or reduce services to persons otherwise eligible for benefits solely on the basis of the participant's inability to pay the fee when charged. A participant's inability to pay a required amount, as due and charged when a service is delivered, shall in no way extinguish the participant's liability to pay the amount due.

As a basis for determining whether an individual is able to pay the charge, the provider is permitted to accept, in the absence of evidence to the contrary, the participant’s statement of inability to pay at the time the charge is imposed.

The provider of service must keep a record of cost sharing amounts collected and of the cost sharing amount due but uncollected because the participant did not make payment when the service was rendered.

13.11.B RECIPIENT RESPONSIBILITY TO PAY THE SHARED PHARMACY DISPENSING FEE AMOUNTS

Unless otherwise exempted, it is the responsibility of the participant to pay the required shared pharmacy dispensing fee amount due. Whether or not the participant has the ability to pay the required shared pharmacy dispensing fee amount at the time the service is furnished, the amount is a legal debt and is due and payable to the provider of service.

13.11.B(1) Exceptions to Shared Pharmacy Dispensing Fee

Under current pharmacy dispensing fee policy all Missouri Medicaid eligible participants are subject to the fee requirement when provided covered pharmacy services, with the exception of the following which are excluded:

• Participants under age 19;

• Institutionalized participants who are residing in a skilled nursing facility, a psychiatric hospital, a residential care facility or an adult boarding home;

• Foster care children up to 21 years of age;

• All Medicare/Medicaid crossover claims as primary coverage;

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• Those drugs specifically identified as relating to family planning services;

• Emergency services; and

• Services provided to pregnant women which are directly related to the pregnancy or a complication of the pregnancy.

Participation in each plan’s pharmacy network shall be limited to providers who accept, as payment in full, the amounts paid by the plan plus any fee amount required of the participant and collected by the provider.

13.11.B(2) Pharmacy Dispensing Fees

Pharmacy dispensing fees are to be collected according to current Medicaid policy for fee-for-service participants and individuals enrolled in an MC+ managed health care plan. The Missouri Medicaid pharmacy fee requirement is considered a portion of the professional dispensing fee and is not deducted from reimbursement to providers.

Ingredient Cost for Each Prescription Member Fee Amount

0 - $10.00 $0.50 $10.01 - $25.00 $1.00 $25.01 - higher $2.00

13.11.C RECIPIENT RESPONSIBILITY TO PAY COPAY AMOUNTS

It is the responsibility of the participant to pay the required copay amount due. Whether or not the participant has the ability to pay the required copay amount at the time the service is furnished, the amount is a legal debt and is due and payable to the provider of service.

The copay requirement is not to be confused with or added to the shared pharmacy dispensing fee amount described in Section 13.11.B. The copay only applies to identified services and participants with certain ME codes.

13.11.C(1) Participants Who are Required to Pay a Copay

Individuals with an ME code of “75,” must pay a $9.00 copay for each prescription billed. The copay amount applies whether the individual receives services on a fee-for-service basis or is enrolled in a health plan.

13.11.C(2) Services Requiring Copay

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The pharmacy copay requirement of $9.00 per prescription for children with ME code “75” applies to each prescription filled, except vaccine billed on a Pharmacy Claim form. There are no other exceptions to this copay requirement. The pharmacy copay requirement for children with ME code “75” is the only copay that applies, and is not to be confused with, or added to the pharmacy dispensing fees applicable to the current Medicaid fee-for-service program requirements, or the current pharmacy dispensing fee requirement of MC+ managed health care plans.

The prescription copay requirement for uninsured adults is based on the ingredient cost of the drug dispensed, as follows:

Ingredient Cost Copay and Dispensing Fee

0 - $10.00 $5.50 $10.01 - $25.00 $6.00 $25.01 - higher $7.00

The copay amount to be collected from a participant is $5.50, $6.00 or $7.00. Of these amounts, $5.00 is deducted from the provider’s reimbursement. The remaining $0.50, $1.00 or $2.00, which corresponds to the participant’s portion of the dispensing fee under Missouri Medicaid, is retained by the provider. The $5.00 copay is deducted from the Medicaid Maximum Allowable for fee-for-service claims reimbursed by the Division of Medical Services.

If the usual and customary amount plus the shared dispensing fee is less than the $5.00 copay to be charged to the participant, the provider should charge the lesser amount of the shared dispensing fee plus the usual and customary amounts.

For example, if the total of the usual and customary amount for a drug ($4.25) plus the shared dispensing fee ($0.50) equals $4.75, the provider should only charge the participant $4.75 because the total is less than the copay amount of $5.00. Do not charge the participant $5.00 or $5.50. If the usual and customary amount is $5.00 or more, the provider should charge the copay and shared dispensing fee.

13.12 MANAGED HEALTH CARE PLAN PHARMACEUTICALS

The MC+ contract states the following policy regarding the coverage of pharmaceuticals under the Missouri MC+ managed health care program. Every product that is covered under the Medicaid Pharmacy Program either without restriction or through prior authorization, except for protease inhibitors, must be covered by the health plans either without restriction or through prior authorization. However, it is not essential that health plans cover pharmaceutical products without

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restriction to the same extent that the fee-for-service program does. Health plans may have a more extensive list of products requiring prior authorization, but health plans may not exclude from coverage any products not excluded under the current Medicaid Pharmacy Program.

Products available under the Medicaid Pharmacy Program must be made available regardless of whether or not the prescriber is in the health plan’s network, but health plans may require that prior authorization be obtained for prescriptions generated by an out-of-plan prescriber except as otherwise noted herein. Any drug prior authorization program implemented by a health plan must meet the following criteria:

• Health plans must provide response by telephone or other telecommunication device within 24 hours of a request for prior authorization.

• Health plans must provide for the dispensing of at least a 72-hour supply of a drug product that requires prior authorization in an emergency situation.

• Approvals must be granted for any medically accepted use. Medically accepted use is defined as any use for a Federal Food and Drug Administration approved drug product, which appears in peer-reviewed medical literature or which is accepted by one or more of the following compendia: the American Hospital Formulary Service—Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia—Drug Information and DRUGDEX.

13.12.A PRIOR AUTHORIZATION

In addition, health plans must have a mechanism whereby drugs can be prior authorized if a member is out of the health plan’s service area and during the time lag between the date of a member’s effective enrollment and that member’s assignment to a primary care provider.

13.12.B FAMILY PLANNING SERVICES

MC+ managed health care plan members have freedom of choice in obtaining family planning services. These services may be obtained from any Medicaid enrolled provider. As such, Depo Provera, when used for family planning purposes, need not be prescribed or administered by the plan member’s primary care physician, nor can coverage be limited to physician offices. Plans may not deny reimbursement to pharmacies dispensing Depo Provera to MC+ managed health care plan enrollees for administration as family planning services, nor can coverage be limited to the plan’s network pharmacies.

Prescriptions for family planning products for MC+ plan enrollees need not be prescribed by the patient’s primary care physician in order to be covered by the plan. Family planning and public health prescriptions written by an advanced practice nurse are covered by the plan. Pharmacy providers should contact the respective plans for directions in billing/claims filing

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for these services. As a reminder, there is no participant dispensing fee requirement for family planning drug products.

13.12.C BEHAVIORAL HEALTH SERVICES

Behavioral health services for MC+ managed health care plan enrollees included in Group 4 are reimbursable on a fee-for-service basis through the Missouri Medicaid Program. Pharmaceutical products provided for these managed health care plan enrollees are the responsibility of the participant’s health plan. Pharmaceutical products used as part of behavioral health services for Group 4 need not be prescribed by a health plan provider in order to be covered. Plans may, however, limit coverage to network pharmacies. Refer to Section 1.5.C for a listing of Group 4 ME codes.

13.13 MANAGED CARE PLAN PROTEASE INHIBITOR CARVE-OUT

Coverage of protease inhibitors for Medicaid beneficiaries enrolled in the MC+ program is not the responsibility of the MC+ managed care plans. These products are covered through the Missouri Medicaid fee-for-service Pharmacy Program for all Medicaid beneficiaries.

13.14 DRUG USE REVIEW (DUR)

The Drug Use Review (DUR) process was established to fulfill a federal requirement established by the Federal Omnibus Budget Reconciliation Act of 1990 (OBRA 90) and state law (208.175 and 208.176, RSMo, Cum. Supp. 1992). Missouri Medicaid has implemented both of the required DUR types - Prospective DUR (when the review of patient drug therapy is done by the pharmacist at the point of sale) and Retrospective DUR (when the review takes place after the point of sale).

13.14.A PROSPECTIVE DUR

State Regulation 13 CSR 70-20.310 requires that Missouri pharmacy providers screen for potential drug therapy problems before each prescription is dispensed to any non-nursing home Medicaid participant. Federal Prospective DUR requirements mandate that the pharmacist’s review include screening to identify potential drug therapy problems of the following types:

• Incorrect drug dosage—the dosage lies outside the daily dosage range specified in predetermined standards as necessary to achieve therapeutic benefit;

• Adverse drug-drug interaction—the potential for, or occurrence of, an adverse medical effect as a result of the participant using two or more drugs together;

• Drug-disease contraindication—the potential for, or occurrence of:

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• an undesirable alteration of the therapeutic effect of a given prescription because of the presence, in the patient for whom it is prescribed, of a disease condition; or

• an adverse effect of the drug on the patient’s disease condition;

• Therapeutic duplication—the prescribing and dispensing of two or more drugs from the same therapeutic class such that the combined daily dose puts the participant at risk of an adverse medical result or incurs additional program costs without additional therapeutic benefit;

• Incorrect duration of drug treatment—the number of days of prescribed therapy exceeds or falls short of the recommendations contained in the predetermined standards;

• Drug-allergy interactions—the significant potential for, or the occurrence of, an allergic reaction as a result of drug therapy; and

• Clinical abuse-misuse—the occurrence of situations referred to in the definitions of abuse, gross overuse, overutilization and underutilization, and incorrect dosage and incorrect duration, as defined in the dot points above.

The goal of Prospective DUR is to identify potential drug therapy concerns to allow the pharmacist to use professional judgment regarding the need for intervention, such as whether or not to contact the prescribing physician.

13.14.A(1) Prospective Drug Use Review (DUR) Through the Electronic Claims Management (ECM) or Point of Service (POS) System

Prospective DUR alerts transmitted through the electronic claims management (ECM) or point of service (POS) system are generated on the basis of predetermined standards which have been approved by the Missouri DUR Board. These predetermined standards utilize data from claims history files which include physician, outpatient, inpatient, long term care facility and other claims that report patient diagnoses, in addition to drug claim data. Reference Section 17.11 for a description of alert responses transmitted via POS.

Providers that do not choose to utilize this service must develop and document their own predetermined standards for evaluating drug therapy.

13.14.A(2) Patient Counseling

As a component of Prospective DUR, federal law requires Medicaid participating pharmacies to offer patient counseling to each participant upon dispensing each prescription. In Missouri, the Board of Pharmacy has required the offer of

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counseling for all patients through State Regulation (4 CSR 220-2.190). As stated in the regulation, “the elements of counseling shall include matters that the pharmacist deems significant in the exercise of professional judgment and are consistent with applicable state laws.”

13.14.A(3) Documentation of Offer to Counsel

As specified in 13 CSR 70-20/310, the pharmacist must document for each Medicaid patient’s prescription in a uniform fashion, whether the offer to counsel was accepted or refused by the patient or her/his agent or caregiver.

Although no standard has been established for such documentation, the information must be easily retrievable by the pharmacy upon request by the Department of Social Services.

13.14.A(4) Patient Profiles

Regulations promulgated by the Board of Pharmacy do not specify what information is required to be maintained in patient profiles. However, due to the federal mandate found at 42 CFR Part 456.705(d), the Division of Medical Services requires in 13 CSR 70-20/310, effective December 10, 1993, that for Medicaid patients, participating pharmacies must make a reasonable effort* to obtain, record and maintain patient profiles containing, at a minimum:

• the name, address, telephone number, date of birth (or age) and gender of the patient;

• individual medical history, if significant, including disease states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and

• pharmacist’s comments relevant to the individual’s drug therapy.

* “Reasonable effort” is defined in the rule to mean that each time a Medicaid patient or his/her agent or caregiver

presents a prescription, the pharmacist or pharmacist’s designee should request profile information verbally or in writing. For example, if the patient presents the prescription in person, the request should be made verbally; and if the prescription is mailed, the request should be made in writing. This does not imply that the service should be denied solely on the basis of the patient’s refusal to supply profile information.

13.14.B RETROSPECTIVE DUR

The Retrospective DUR system applies to all Medicaid participants (both fee-for-service and MC+) and focuses on drug regimen reviews after the patient has received a prescription. It

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targets potential therapy problems that result after a period of time, possibly characterized by an exacerbated medical condition or the appearance of a drug side effect.

The Division of Medical Services has entered into an outside contract for production of computerized patient reports or “patient profiles.” These patient profiles are generated by applying therapeutic criteria to paid Medicaid claims data. Therapeutic criteria is reviewed and approved by the DUR Board. Rather than using a single statewide committee to review all patient profiles, Missouri has instituted a regional approach, dividing the state into 6 different regions (St Louis, Kansas City, Columbia, Kirksville, Springfield and Cape Girardeau) with a separate review committee in each region.

These committees, composed of pharmacists and physicians actively practicing in their region, are responsible for reviewing the profiles for patients of their colleagues practicing in their specific region.

The purpose of the profile reviews is to detect potential drug therapy problems and to bring the information to the attention of the treating physician and dispensing pharmacist. The information is presented in an informational manner and is not intended to be punitive in any way. Reimbursement of claims are not affected by DUR interventions, nor are provider sanctions employed. Letters contain a summary of the potential problem, along with a copy of the patient profile and a response form for the provider’s return.

13.15 EMERGENCY SERVICES

Emergency services are services required when there is a sudden or unforeseen situation or occurrence or a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in:

1. Placing the patient’s health in serious jeopardy; or

2. Serious impairment to bodily functions; or

3. Serious dysfunction of any bodily organ or part.

13.16 OUT-OF-STATE, NONEMERGENCY SERVICES

All nonemergency, Medicaid covered services that are to be performed or furnished out-of-state for eligible Missouri Medicaid participants and for which Missouri Medicaid is to be billed, must be prior authorized before the services are provided. Services that are not covered by the Missouri Medicaid Program are not approved.

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Out-of-state is defined as not within the physical boundaries of the State of Missouri nor within the boundaries of any state that physically borders on the Missouri boundaries. Border-state providers of services (those providers located in Arkansas, Illinois, Iowa, Kansas, Kentucky, Nebraska, Oklahoma and Tennessee) are considered as being on the same Medicaid participation basis as providers of services located within the State of Missouri.

A Prior Authorization Request form is not required for out-of-state nonemergency services. To obtain prior authorization for out-of-state, nonemergency services, a written request must be submitted by a physician to:

Division of Medical Services Participant Services Unit P.O. Box 6500 Jefferson City, MO 65102

The request may be faxed to (573) 526-2471.

The written request must include:

1. A brief past medical history.

2. Services attempted in Missouri.

3. Where the services are being requested and who will provide them.

4. Why services can’t be done in Missouri.

NOTE: The out-of-state medical provider must agree to complete an enrollment application and accept Missouri Medicaid reimbursement. Prior authorization for out-of-state services expires 180 days from the date the specific service was approved by the state.

13.16.A EXCEPTIONS TO OUT-OF-STATE PRIOR AUTHORIZATION (PA) REQUESTS

The following are exempt from the out-of-state prior authorization requirement:

1. All Medicare/Medicaid crossover claims.

2. All Foster Care children living outside the State of Missouri. However, nonemergency services that routinely require prior authorization continue to require prior authorization by out-of-state providers even though the service was provided to a Foster Care child.

3. Emergency ambulance services.

4. Independent laboratory services.

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13.17 HOSPICE

Refer to Section 1.5.E for a full description of hospice beneficiaries. The Medicaid hospice benefit includes covered services provided according to a written plan of care. All drugs (prescription and over the counter) and biologicals used primarily for pain or symptom control of the terminal illness are the responsibility of the hospice provider. Any service or treatment that is not directly related to pain control or palliation of the participant’s terminal illness is not the responsibility of the hospice and can be reimbursed on a fee-for-service basis.

13.17.A PHARMACY REIMBURSEMENT

The plan of care must indicate all medication the patient uses and whether the medication is related to the terminal illness. Missouri Medicaid reimburses Medicaid pharmacy providers for pharmacy claims that are not related to the hospice patient’s terminal diagnosis. It is the responsibility of the hospice to provide documentation that verifies that specific medication is not related to the terminal diagnosis. The hospice should provide a letter or statement to the pharmacy that includes the following information:

Patient name;

Patient Medicaid ID Number (DCN);

Service dates;

Drug name(s);

Statements that the named drugs are not the responsibility of the hospice.

13.18 DIABETES SELF-MANAGEMENT TRAINING

Diabetes self-management training services are used in the management and treatment of type 1, type 2 and gestational diabetes. These services are covered when prescribed by a physician or a health care professional with prescribing authority and may be provided by a Certified Diabetes Educator (CDE), Registered Dietician (RD) or Registered Pharmacist (RPh).

13.18.A DIABETES SELF-MANAGEMENT TRAINING ENROLLMENT CRITERIA

To provide and bill for diabetes self-management training, a provider must be approved and enrolled as a diabetes self-management provider with Missouri Medicaid. Missouri Medicaid has established a new provider type—35–Diabetes Management Training—with three new provider specialties: F1–Certified Diabetes Educator (CDE), F2–Registered Dietician (RD) and F3–Registered Pharmacist (RPh). Following are the requirements to enroll as a F3–Registered Pharmacist (RPh) under the Diabetes Self Management Training program:

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Registered Pharmacist (RPh): Must hold a permanent Missouri license as licensed pharmacist and must have completed the National Community Pharmacists Association (NCPA) "Diabetes Care Certification Program" OR completed the American Pharmaceutical Association (APhA)/AADE certification program "Pharmaceutical Care for Patients with Diabetes."

Diabetes education providers employed/contracted with federally qualified health centers (FQHCs) or rural health clinics (RHCs) bill with their individual diabetes self-management training provider number with payment designated to the FQHC or RHC.

Diabetes education services provided on an inpatient basis by hospital staff are included in the hospital per diem rate.

When diabetes education services are provided in an outpatient setting by hospital staff, the CDE, RD or RPh enrolls as a diabetes self-management training provider with payment designated to the hospital on the provider enrollment forms.

13.18.B DIABETES SELF-MANAGEMENT TRAINING SERVICE LIMITATIONS

Diabetes self-management training services are limited to any of the following circumstances with documentation of the need for services maintained in the provider's file:

• Initial diagnosis of diabetes;

• Any significant change in the patient's symptoms, condition or treatment.

Diabetes self-management training must be prescribed by a physician or health care provider with prescribing authority to the CDE, RD or RPh.

An initial assessment is reimbursed once per lifetime. The initial assessment must be performed by a physician or a CDE.

The initial assessment should include but not be limited to information from the patient on the following:

• Health and medical history;

• Use of medications;

• Diet history;

• Current mental health status;

• Use of health care delivery systems;

• Life-style practices;

• Physical and psychological factors;

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• Barriers to learning; family and social supports; and

• Previous diabetes education, actual knowledge and skills.

Two subsequent visits are reimbursed per rolling year. The two subsequent visits may be individual, group or a combination of individual and group.

Any additional visits require a Certificate of Medical Necessity form from a physician or health care provider with prescribing authority documenting the need for any additional visits. The Certificate of Medical Necessity form must be submitted with the claim.

The diabetes self-management training services for patients enrolled in MC+ are the responsibility of the health plan.

13.18.B(1) Procedure Codes for Diabetes Self-Management Training

PROC CODE (Prior to 10/16/2003 date of service)

PROC CODE (On or after 10/16/2003 date of service)

DESCRIPTION

W0037..................99205 U9..............Initial Assessment–Comprehensive Diabetes Education–Minimum 1 hour

W0038..................G0108...................Diabetes Education–Subsequent Visit–Minimum 30 minutes

W0039..................G0109...................Diabetes Education–Group Subsequent (No more than 8 persons)–Minimum 30 minutes

13.18.B(2) Diabetes Self-Management Training Billing Procedures

The diabetes self-management training services must be billed on the CMS-1500 claim form using type of service (TOS) code "1", with the appropriate procedure code.

The place of service (POS) code must be one of the following: 11 (Office); 12 (Home); 97 (Private/Parochial School); 98 (Schools); 21 (Inpatient Hospital); or 22 (Outpatient Hospital).

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Electronic billing of claims is permitted unless claims require an attachment of a Certificate of Medical Necessity form or any other attachment. Those claims requiring an attachment must be billed on a paper CMS-1500 claim form.

Training provided by a CDE, RD or RPh not employed by the hospital, must be billed using POS 21 (Inpatient Hospital) or 22 (Outpatient Hospital) using their own diabetes self-management training provider number.

13.19 DIABETIC SUPPLIES

All diabetic supplies are reimbursed through the Pharmacy Program, via point of service, Internet or on a paper Pharmacy Claim form. Durable medical equipment only providers may also continue to bill for diabetic supplies, but are now required to bill an Internet claim or on a paper Pharmacy Claim form. These supplies are not reimbursed through the Durable Medical Equipment Program. Reference Diabetic Supplies for detailed information regarding the supplies and billing information.

Effective March 6, 2004, Precision Xtra Advanced Diabetes Management System, Precision Xtra blood glucose test strips, Precision Xtra blood ketone test strips, and Precision Sure-Dose Insulin Syringe are the only brands Missouri Medicaid fee-for-service covers without prior authorization. To obtain a non-reference product, prior authorization for other brands are reviewed on an individual patient basis and evaluated for medical necessity.

Insulin pumps continue to be available only through the prior authorization process. The authorized prescriber may request the prior authorization by faxing the Diabetic Supplies Prior Authorization form to (573) 636-6470.

Insulin pump supplies do not require prior authorization. For claims processing of insulin pump supplies, the provider must code the claim with a UB service modifier. When a claim is submitted with the UB modifier, it will suspend for claim review. Providers billing for these suplies must have and maintain documentation that the patient has been seen and evaluated by the treating physician every 3 months. In addition, the external insulin infusion pump therapy must be ordered and follow-up care rendered by a physician who manages multiple patients on continuous subcutaneous insulin infusion therapy and who works closely with a team including nurses, diabetic educators and dieticians who are knowledgeable in the use of continuous subcutaneous insulin infusion therapy.

Diabetic supplies for Medicare eligible patients, except for insulin syringes, are reimbursed by Medicare. Providers are to bill Medicare according to Medicare established policies for diabetic supplies.

13.20 MISSOURI MEDICAID DISEASE STATE MANAGEMENT PROGRAM

Pharmacy Manual

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Section 13 - Benefits and Limitations

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The Missouri Medicaid Disease State Management Program was designed to improve the healthcare of patients who suffer from chronic conditions such as asthma, diabetes, heart failure and depression. Physicians and pharmacists work as a team to achieve these primary goals:

• Improve patient care

• Improve health outcomes

• Reduce inpatient hospitalization

• Reduce emergency room visits

• Lower total costs

• Better educate patients and providers

Specific and up-to-date information on the Missouri Medicaid Disease State Management Program including provider and patient enrollment information, provider education and training, patient education, care plan guidelines, assessment/care plan forms, and billing instructions may be accessed at Disease Management.

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Last Updated - 06/27/2008Archived - 05##2012

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