KANSAS MEDICAL ASSISTANCE PROGRAM Provider Manual Pharmacy Updated 08/2012 PART II PHARMACY PROVIDER MANUAL Introduction Section 7000 7010 8100 8300 8400 Appendix I FORMS BILLING INSTRUCTIONS Pharmacy Billing Instructions ... ............ ............ ............ ............ ............ Pharmacy Billing Information ... ............ ............ ............ ............ ............ Page 7-1 7-2 BENEFITS AND LIMITATIONS Copayment ...... ............ ............ ............ ............ ............ ............ ............ MediKan ......... ............ ............ ............ ............ ............ ............ ............ Medicaid ......... ............ ............ ............ ............ ............ ............ ............ Pharmacy Benefits and Limitations ........ ............ ............ ............ Drug Benefit Limitations ........... ............ ............ ............ ............ 8-1 8-2 8-3 8-3 8-19 NCPDP reject codes All forms pertaining to this provider manual can be found on the public website at https://www.kmap-state-ks.us/Public/forms.asp and on the secure website at https://www.kmap-state-ks.us/provider/security/logon.asp under Pricing and Limitations. CPT codes, descriptors, and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All rights reserved. Applicable FARS/DFARS apply. Information on the American Medical Association is available at http://www.ama-assn.org. PART II PHARMACY PROVIDER MANUAL Updated 04/12 This is the provider specific section of the manual. This section (Part II) is designed to provide information and instructions specific to pharmacy providers. It is divided into three subsections: Billing Instructions, Benefits and Limitations, and Appendix. The Billing Instructions subsection provides information on completing and submitting paper claims. An example of the claim form and instructions are on the public and secure websites at: • https://www.kmap-state-ks.us/Public/forms.asp • https://www.kmap-state-ks.us/provider/security/logon.asp The Benefits and Limitations subsection defines specific aspects of the scope of pharmacy services allowed within the Kansas Medical Assistance Program (KMAP). HIPAA Compliance As a participant in KMAP, providers are required to comply with compliance reviews and complaint investigations conducted by the Secretary of the Department of Health and Human Services as part of the Health Insurance Portability and Accountability Act (HIPAA) in accordance with section 45 of the code of regulations parts 160 and 164. Providers are required to furnish the Department of Health and Human Services all information required by the Department during its review and investigation. The provider is required to provide the same forms of access to records to the Medicaid Fraud and Abuse Division of the Kansas attorney general's office upon request from such office as required by K.S.A. 21-3853 and amendments thereto. A provider who receives such a request for access to or inspection of documents and records must promptly and reasonably comply with access to the records and facility at reasonable times and places. A provider must not obstruct any audit, review or investigation, including the relevant questioning of employees of the provider. The provider shall not charge a fee for retrieving and copying documents and records related to compliance reviews and complaint investigations. 7000. PHARMACY BILLING INSTRUCTIONS Updated 06/12 Pharmacy providers can contact the pharmacy help desk toll-free number for assistance with pharmacy claims questions at 1-866-405-5200. Introduction to the Pharmacy Claim Form Pharmacy providers must use the Pharmacy Claim Form when requesting payment for items provided under KMAP (unless submitting electronically). An example of the claim form and instructions are on the public and secure websites at: • https://www.kmap-state-ks.us/Public/forms.asp • https://www.kmap-state-ks.us/provider/security/logon.asp The Kansas MMIS uses electronic imaging and optical character recognition (OCR) equipment. Therefore, information will not be recognized if not submitted in the correct fields as instructed. The Pharmacy Claim Form can be ordered through the fiscal agent. Refer to Section 1100 in the General Introduction Provider Manual. For paper claim submissions for compounds, bill only one compound prescription per paper claim; do not mix compound claims with noncompound claims. Billing Unit Standard for Pharmacy Claims KMAP requires the use of the National Council Prescription Drug Program (NCPDP) billing unit standard (BUS) for pharmacy claims. This standardization of billing units was developed to ensure consistency in how medications are billed. According to BUS, there are three acceptable billing units: 1. Each (EA)—Products that are measured in individual units and not measured by volume or weight are billed as the number of each dispensed such as tablets and capsules 2. Milliliters (ML)—Products that are measured by their liquid volume such as solutions, injectables, and inhalers (when labeled as milliliters on product) 3. Grams (GM)—Products that are measured by their weight such as ointments, creams, and inhalers (when labeled as grams on the product) For more details, refer to the NCPDP Billing Unit Standard Fact Sheet on the NCPDP website. Key things to remember regarding billing units: • Values must be expressed in metric decimal units. Rounding is not allowed. • The billing unit and quantity are taken from the product labeling that is affixed to the product. • Use standard apothecary conversions to convert quantities dispensed to the appropriate standard billing units. For complete definitions and further clarification of the NCPDP BUS, refer to the Standards page of the NCPDP website. Another resource for specific NDC billing units is the NDC Search function on the KMAP website. The NDC Search function is under the Provider tab, then Reference Codes and NDC Search. Enter a specific NDC in 11-digit format, the beneficiary’s benefit plan, and the date of service. Once the coverage information is displayed, double-click on the NDC for the billing units and other coverage information. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-1 7010. PHARMACY BILLING INFORMATION Updated 04/12 Adjustments and Reversals There will no longer be a limitation for point of sale (POS) reversal transactions or Internet adjustments to reverse or void pharmacy claims based on dispense date. However, providers must still follow the 12- and 24-month timely filing requirements outlined in Section 5100 of the General Billing Provider Manual. Long-Term Care Returned Medication Process • Due to concerns raised with misapplication of the NCPDP’s Version 5.1 Quantity Dispensed (442-E7) and Days Supply (405-D5) fields, note the following changes in the process to receive incentive payments for returned medications for beneficiaries residing in long-term care facilities. • KMAP recommends processing an adjustment as the first step of the incentive fee process (as opposed to a POS reversal). This is particularly important if your POS software does not allow for appropriate tracking of reversed or resubmitted claims in returned medication situations. o Process an adjustment for the original paid claim and original prescription number. The adjusted claim is to reflect the quantity of drug used. See Section 5600 of the General Billing Provider Manual for procedures to submit an adjustment. For additional information on how to submit an adjustment on the KMAP secure website, contact Customer Service at 1-800-933-6593. o Document the following information: Date of original service (dispense date), original prescription number, and original claim internal control number (ICN) Date adjustment was submitted to KMAP Dollar amount of unused medication, called credited prescription amount (CPA) To calculate the CPA, subtract the dispensing fee ($3.40) from the original payment. Divide that amount by the number of units (tabs/caps) originally dispensed, resulting in the paid amount per unit. Multiply the paid amount per unit by the number of unused tabs/caps that were returned, resulting in the CPA. KMAP uses the CPA to calculate the incentive fee, based on the table below. If the CPA is less than $5.00, no incentive fee is paid. Credited Prescription Amount Incentive Fee $0.01 to $4.99…………………………….……..$0.00 $5.00 to $8.25…………………………………...$1.70 $8.26 to $11.50………………………………….$2.50 $11.51 to $14.75………………………………...$3.25 $14.76 to $17.99………………………………...$4.00 $18.00 and over…………………………………$4.50 o Submit the required information to: Office of the Fiscal Agent Attn: Pharmacy – LTC Returned Medications P.O. Box 3571 Topeka, KS 66601-3571 KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-2 7010. Updated 07/11 Medicare Part B • Pharmacy providers are required to bill Healthcare Common Procedure Coding System (HCPCS) codes and common procedural terminology (CPT®) codes on Medicare Part B designated drugs for Medicare Part B beneficiaries. Providers must be enrolled as a DME provider and supply KMAP with the provider’s Medicare provider number so that the claims will automatically cross over from Medicare. This process must be followed for the coinsurance and deductible to be considered for payment. Refer to Section 7000 of the Durable Medical Equipment Provider Manual, Section 7000, for detailed billing instructions. • To process these claims correctly, the claim must be billed with only one detail. If more than one detail is billed, the claim will be denied. Medicare Part D • The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 created the Medicare Part D prescription benefit, which took effect January 1, 2006. Medicare D plans are administered entirely by private sector for-profit entities. These private entities, known as Prescription Drug Plans (PDP), will provide pharmacy benefits based on statutory and regulatory requirements. All plans must be approved by the Centers for Medicare & Medicaid Services (CMS) which has oversight responsibility for Medicare Part D. • KMAP considers all Medicare A and/or B beneficiaries entitled to Medicare Part D. Beneficiaries who receive coverage under KMAP and are entitled to Medicare Part D should be enrolled with a PDP. Pharmacy claims for these beneficiaries will deny if the drug is considered a covered Medicare Part D drug. Any of these drugs should be billed to the beneficiary’s Medicare D PDP or Medicare B carrier for payment. • KMAP will consider for payment the following: o Medicare excluded drugs covered by KMAP o Patient responsibility for AIDS Drug Assistance Program (ADAP) formulary drugs when the KMAP beneficiary has ADAP only or ADAP plus medically needy (MN) with unmet spenddown, plus is eligible for Medicare D o Medicare Part D copay assistance for beneficiaries with full dual eligibility on Medicare Part D drugs To learn more about each special situation, read the appropriate section below. Medicare Part D Exclusions • Drug classes that may be noncovered (carved out) by the Part D drug benefit are in the following high-level list. Providers are required to submit claims to the PDP prior to KMAP for all beneficiaries entitled to Part D. • Drugs in the following categories will continue to process according to the KMAP coverage guidelines currently in place. Implementation of the Medicare Part D program has no effect on the drugs currently covered by KMAP for beneficiaries not entitled to Part D coverage. In addition, prior authorization (PA) and medical necessity cannot be used to override the denial of coverage based on the beneficiary being entitled to Medicare Part D. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-3 7010. Updated 12/11 Medicare Part D continued • Part D Excluded Drugs o Agents when used to promote fertility o Agents when used for anorexia, weight loss or weight gain o Agents when used for cosmetic purposes or hair growth o Agents when used for the symptomatic relief of cough and colds o Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations o Nonprescription drugs o Barbiturates o Benzodiazepines o Outpatient drugs for which the manufacturer requires associated tests or monitoring services to be purchased exclusively from the manufacturer or its designee as a condition of sale o Agents when used for the treatment of sexual or erectile dysfunction (ED) and ED drugs for off-label use • Drugs Covered by Medicare Parts A and B o Drugs currently covered by Medicare Parts A and B should continue to be billed to the Medicare Part A and B carriers. o Implementation of the Part D program does not change the coverage of drugs currently billed to Parts A and B. Medicare Part D Patient Responsibility for ADAP Formulary Drugs KMAP assists with patient responsibility on ADAP formulary drugs for beneficiaries with the following eligibility: • ADAP only and entitled to Medicare Part D • ADAP plus MN with unmet spenddown and entitled to Medicare Part D Note: Patient responsibility is considered any amount owed after Part D and all other primary insurance sources have been properly adjudicated. Points to Note Regarding ADAP Formulary Drugs • Assistance with patient responsibility does not apply to full dual eligible beneficiaries. • KMAP considers patient responsibility any amount due after all other insurance sources have been properly adjudicated. • Once spendown is met for MN beneficiaries, they become eligible for full dual benefits and claims should be submitted to the Part D Plan. After adjudication with the Medicare Part D Plan, Medicare Part D copay assistance is applicable. • KMAP assists with patient responsibility on ADAP formulary drugs only. • Non-ADAP formulary drugs are the responsibility of the beneficiary. How to Bill Medicare Part D Patient Responsibility for ADAP Formulary Drugs • Billing and payment for patient responsibility on the beneficiaries listed above for an ADAP formulary drug is available through POS. Pharmacy providers need to contact their software vendors to assess if any changes are needed. Vendors must use the current KMAP Management Information System Interface Specifications NCPDP Transaction Payer Sheets document. This is listed as NCPDP at https://www.kmap-state-ks.us/Public/EDI/companion.asp. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-4 7010. Updated 12/11 Medicare Part D continued • The following NCPDP D.0 fields and associated values are to be used for POS submission of Medicare Part D Patient Responsibility for ADAP formulary drug claims: Claim Segment • Other Coverage Code (308-C8) = 8 (Claim is billing for a copay.) Coordination of Benefits (COB) Segment • Other Payer-Patient Responsibility Amount Count (353-NR) = 1 (One occurrence) • Other Payer-Patient Responsibility Amount Qualifier (351-NP) = 06 (Patient pay amount) • Other Payer-Patient Responsibility Amount (352-NQ) = Patient Responsibility Amount (Amount remaining after Medicare Part D and other primary insurance sources have been properly adjudicated.) Medicare Part D Copay Assistance • KMAP provides copay assistance to beneficiaries who have both full Medicare Part D entitlement and one of the following: o Title XIX Medicaid (TXIX) o Medical needy with no spenddown or spenddown has been met • The Medicare Part D Copay Assistance does not occur automatically with the submission of the claim to the Medicare Part D drug plan. • KMAP pharmacy providers are reimbursed according to the Medicare Part D copay amount billed minus any KMAP copay and the days supply on the claim as listed on the chart below: Days Supply 2007 2008 2009 2010-2011 2012 1-30 5.35 5.60 6.00 6.30 6.50 31-60 10.70 11.20 12.00 12.60 13.00 61-90 16.05 16.80 18.00 18.90 19.50 Points to Note Regarding Medicare Part D Copay Assistance • KMAP will deny Medicare Part D copay claims submitted with a days supply greater than 90. • KMAP will deny Medicare Part D copay claims submitted for a beneficiary not recognized with full dual eligibility. • KMAP assistance with the Medicare Part D copay is the lesser of the Medicare Part D copay versus the maximum reimbursement per day’s supply. For example, if the Medicare Part D copay is $3.45 for a 30-day supply, KMAP will pay up to $3.45 (and not $6.00) minus any KMAP copay. If the Medicare Part D copay is $6.00 for a 30-day supply, KMAP will pay $6.00 minus any KMAP copay. • Instances may occur where beneficiaries have Medicare Part D copay amounts greater than the standard allowed. Several variables could cause this situation. For instance, the Prescription Drug Plan (PDP) does not have the beneficiary coded with full dual eligibility. Providers should continue to follow the current process for resolving these issues. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-5 7010. Updated 12/11 Medicare Part D continued • Instances may occur where KMAP’s assistance with the Medicare Part D copay is reduced to zero or to a low amount (such as $0.10) due to the KMAP copay. In this situation, you are not required to submit the copay assistance claim to KMAP. However, if you decline to submit it, this must be considered a write-off. The beneficiary is not to be charged the KMAP assistance portion of the copay. How to Bill the Medicare Part D Copay Assistance • Billing and payment for a beneficiary eligible for Medicare Part D copay is available via POS only. KMAP pharmacy providers need to contact their software vendors to assess if any changes are needed. Vendors must use the current Kansas Medical Assistance Program Management Information System Interface Specifications NCPDP Version D.0 and 1.2 Transaction Payer Sheets document. This is listed as NCPDP and located at https://www.kmap-state-ks.us/Public/EDI/companion.asp. • The following NCPDP D.0 fields and associated values are to be used for POS submission of Medicare Part D copay claims: Claim Segment • Other Coverage Code (308-C8) = 8 (Claim is billing for a copay.) COB Segment • Other Payer-Patient Responsibility Amount Count (353-NR) = 1 (One occurrence) • Other Payer-Patient Responsibility Amount Qualifier (351-NP) = 06 (Patient pay amount) • Other Payer-Patient Responsibility Amount (352-NQ) = Patient Responsibility Amount (Amount remaining after Medicare Part D and other primary insurance sources have been properly adjudicated.) Payment Response from KMAP for a Medicare Part D Copay Assistance KMAP providers can expect to receive the KMAP amount paid for the Medicare Part D copay in the Total Amount Paid field (509-F9). Any remaining patient responsibility or KMAP copay will be returned in the Patient Pay Amount field (505-F5). Primary Insurance Other Than Medicare Part D KMAP continues to consider payment of any unpaid allowed charges by the primary insurance and not the copay from the primary insurance. Therefore, no changes are required to the current billing process when pharmacy providers bill KMAP primary insurance paid claims (excluding Medicare Part D as primary). Refer to Section 3300 in the current General TPL Payment Provider Manual on the KMAP website for further assistance. Inability to Pay Copay Kansas Legislature provided limited funds to assist with eligible Medicare Part D copays. Since this assistance is funded through All State Funds, providers may refuse service when a beneficiary cannot pay any leftover Medicare Part D copay after KMAP has applied the maximum allowed for Medicare Part D copay per your provider agreement. Notes: • This rule applies only when KMAP assists with Medicare Part D copay. • Providers cannot refuse service for a beneficiary’s inability to pay his or her copay for all other KMAP paid services. Refer to the General TPL Payment Provider Manual, Section 3000, for more information. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-6 7010. Updated 12/11 Submission of NPIs Previously, prescribing providers may have been identified by the DEA number or KMAP provider ID. They must now be identified by the NPI on all electronic claims. Previously, pharmacy providers may have been identified by KMAP provider ID. Pharmacy providers must now be identified by the NPI on all electronic claims. Submission of Prescribing Provider Identifier • Pharmacy providers must submit all electronic claims with the prescribing provider’s unique NPI. Paper claims must be submitted with the prescribing provider’s NPI or KMAP provider ID. The following information is required for KMAP pharmacy claims: o POS: Submit the NPI qualifier (01) in the Prescriber ID Qualifier field (466-EZ). Submit the prescriber’s NPI in the Prescriber ID field (411-DB). o Internet: Submit the prescriber’s NPI in the Prescriber NPI field. o Provider Electronic Solutions (PES): Submit the prescriber’s NPI in the Prescriber NPI field. o Paper: Submit the prescribing provider’s NPI or KMAP provider ID in the Prescribing Physician Medicaid Number field (field 8). • Pharmacy providers can search for a prescribing provider’s NPI using the secured KMAP website. Only the NPIs for KMAP-enrolled prescribing providers who have shared their NPI with KMAP are available. This feature is available to users associated with a provider ID enrolled as a pharmacy provider type. To search for a prescribing provider’s NPI, follow the steps below: o Log on to the secured KMAP website. o Click Prescribing NPI Search. o Select the prescribing provider type (physician, advance practice nurse, dentist, mid-level practitioner, optometrist, or podiatrist). Note: The search can be narrowed by entering the provider’s last name or beginning characters of the last name, city, or ZIP code. The county and state can also be selected from drop-down lists. o Click Search to display the results. The prescribing provider’s name, phone number, and NPI are included in the results. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BILLING INSTRUCTIONS 7-7 BENEFITS AND LIMITATIONS 8100. Updated 04/10 Copayment There will be a $3 charge per new or refilled prescription per date filled. Refer to Section 3000 of the General Third Party Liability Payment Provider Manual for exceptions. Note: Only one $3 copayment charge will be assessed per compound prescription (even though one compound may be made up of multiple single claims.) Do not reduce charges or balance due by copayment amount. This reduction will be made automatically by the fiscal agent. Note: For beneficiary copayments related to eligible Medicare Part D copay assistance claims, please refer to Section 7010 of this manual. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-1 BENEFITS AND LIMITATIONS 8300. Updated 04/10 Benefit Plan Pharmaceutical benefits for MediKan beneficiaries are limited to prescription drugs that have been approved for MediKan coverage. To determine MediKan coverage for an NDC, providers can access the following resources: • KMAP website – Providers can access the KMAP website at https://www.kmap-state-ks.us/. NDC coverage can be verified under the Provider menu item by choosing Reference Codes then NDC Search. To conduct a search without logging into the secure site, select MediKan from the list of benefit plans in order to search for applicable MediKan coverage. • Automated Voice Response System (AVRS) – AVRS can be accessed at 1-800-933-6593. Refer to Section 2000 of the General Benefits Provider Manual for information on the plastic State of Kansas Medical Card and eligibility verification. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-2 BENEFITS AND LIMITATIONS 8400. Updated 12/11 PHARMACY BENEFITS AND LIMITATIONS COUNSELING REQUIREMENTS • KMAP pharmacy providers will provide prescription drug counseling as is currently required under Kansas Administrative Regulation 68-2-2(e). Standards and criteria to be used for counseling will be as stated in the United States Pharmacopoeia Drug Information (USP DI), the American Medical Association Drug Evaluations (AMA DE), and the American Hospital Formulary Service Drug Information (AHFS DI), and such standards and criteria as are subsequently adopted by the Division of Health Care Finance. • Before each prescription is dispensed or delivered, the pharmacist must offer (and document the refusal or actual counseling subsequent to such offer) to discuss with each KMAP beneficiary or caregiver of such individual (in person, whenever practicable, or through access to a telephone service which is toll-free for long-distance calls) who presents a prescription, matters which, in the exercise of the pharmacist's professional judgment, the pharmacist deems significant including the following: o The name and description of the medication o The dosage form, dosage, route of administration, and duration of drug therapy o Special directions and precautions for preparation, administration and use by the patient o Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur o Techniques for self-monitoring drug therapy o Proper storage o Prescription refill information o Action to be taken in the event of a missed dose • A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following "patient profile" information regarding KMAP beneficiaries: o Name, address, telephone number, date of birth (or age), and gender o Individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices o Pharmacist comments relevant to the beneficiary's drug therapy • Documentation of actual counseling performed may be by check-off box, on the profile, or recorded elsewhere, but must be readily retrievable for each prescription filled or refilled. Verification of individual pharmacy policies and procedures, as well as documentation of actual counseling information may be requested either by on-site personnel or by request to submit copies. On-site personnel may also conduct "face-to-face" counseling as appropriate. Nothing in this policy shall be construed as requiring a pharmacist to provide consultation when a beneficiary or caregiver of such individual refuses such consultation; however, such refusal shall be documented. • The verbal offer to counsel for each prescription medication order, the collection of patient data for the Patient Profile, and the documentation of counseling done or refused, may be delegated by the pharmacist to competent supportive/technical personnel working under a pharmacist's direct supervision. The verbal counseling, however, must be performed by a registered pharmacist. Written consultation material may be provided in addition to the verbal counseling. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-3 8400. Updated 04/12 COUNSELING REQUIREMENTS continued • An exception is allowed for drugs dispensed to residents of nursing facilities which are in compliance with the drug regimen review procedures for such facilities. Therefore, the verbal counseling requirements for the dispensing pharmacist are optional for medications dispensed and delivered to nursing facilities for their residents. DISPENSING FEE The following table summarizes the professional pharmacy fee (dispensing fee) history. The professional fee listed is per claim based upon dates of service. Professional Fee $3.40 $4.50 Provider Specific Dates of Service Effective July 1, 2002 Effective August 1, 2000 Prior to August 1, 2000 Note: The above dispensing fee information is not applicable to Medicare Part D copay assistance claims. Refer to Section 7010 of this manual for these claims. DUR ALERTS Auto Deny DUR Alerts (These alerts are in hierarchy order.) Refill Too Soon DUR alert that will auto-deny when the same medication has been filled by the same provider or by a different provider and less than 80% of supply has been used. Pregnancy Alert DUR alert that will auto-deny when a female is flagged as pregnant on the pharmacy claim and the drug submitted is a category X or a First Data Bank value of 1. Therapeutic Duplication Therapeutic Duplication is when two or more drugs from the same therapeutic class are prescribed, such that the combined daily dose increases the risk of toxicity or incurs additional program costs without additional therapeutic benefit. DUR alert that will auto-deny when a prescription is filled and less than 80% of supply has been used of another prescription which is considered therapeutically equivalent by KMAP. Including: • Proton pump inhibitors • NSAIDS • Cox II inhibitors • NSAID & proton pump inhibitor combination products • H2 antagonists Allowed Exceptions for Auto-Deny DUR Alerts In order to override an auto-deny DUR alert, the provider must determine if the prescription meets the following criteria for the highest ranking alert listed in order of hierarchy under “Auto-Deny DUR Edits.” Beneficiaries who do not meet the criteria for the highest ranking auto-deny alert set may pay for the medication out-of-pocket. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-4 8400. Updated 09/11 DUR ALERTS continued If the denial is overridden, the provider must maintain documentation of the reason and input the proper override values on the claim in the NCPDP DUR Reason for Service code, Professional Service code, and Result of Service code fields. Note: Overrides are not allowed for stolen or vacation medications. Refill Too Soon Allowed Exceptions • Therapy change resulting in an increase in number of units per day, applies to all beneficiaries. Note: A change in the time the medication dose is administered does not meet the preceding criteria. • Lost or spilled medications, applies to beneficiaries ages 18 and younger only. Pregnancy Alert Allowed Exceptions • Beneficiary is not pregnant. • Physician and beneficiary are aware of the drug’s teratogenic effects and authorization to dispense has been given after the pharmacist consults with the physician. Therapeutic Duplication Allowed Exceptions • Strength or dosage change: a different strength (either higher or lower) of the same medication is required, with a valid, medically necessary reason for the change documented. • Switch over: a medication change is required within the same therapeutic drug class, with a valid, medically necessary reason for the change documented. Guidelines to Help Identify DUR Alerts Claims setting DUR alerts can auto-deny or pay-but-report. Any set will return pertinent information to the provider, including the DUR Reason for Service code in the DUR Response Data fields. The first alert returned to the provider in the DUR Response Data fields is considered the most significant. The provider can contact Customer Service for further DUR information. Also, any auto-deny alert set will cause an NCPDP Reject Code to be returned to the provider. This reject code along with the DUR Response helps a provider determine what alert set. The following table contains information to help a provider determine what auto-deny DUR alert was set and if provider intervention is necessary. Remember, provider action requires certain criteria to be met as explained previously. DUR EXCEPTION DUR REASONS FOR SERVICE DUR PROFESSIONAL SERVICE CODE DUR RESULT OF SERVICE Refill Too Soon ER M0 P0 R0 Pregnancy, Category X, D, or FDB value 1 Therapeutic Duplication PG M0 P0 R0 TD M0 P0 R0 1A 1B 1C 1D 1E 1F 1G 2A 2B 1A 1B 1C 1D 1E 1F 1G 2A 2B 1A 1B 1C 1D 1E 1F 1G 2A 2B KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-5 8400. Updated 09/11 IMMUNIZATION ADMINISTRATION BY CERTIFIED PHARMACISTS • Pharmacy providers certified to administer vaccine to adults, in accordance with K.S.A. 65-1626, will be allowed to bill Medicaid for vaccine administration. • Certified pharmacists are required to submit proof of certification required by K.S.A. 65-1626 to the Medicaid Provider Enrollment department in order to be eligible for vaccine administration reimbursement. Pharmacists will receive a new specialty which will allow these services to be billed to Medicaid using the provider’s durable medical equipment (DME) number. • Refer to Section 7020 of the DME Provider Manual for a list of procedure codes that are covered. The procedure codes must be filed on a CMS-1500 claim form using the provider’s DME number. INDIAN HEALTH SERVICES ENROLLED AS PHARMACY PROVIDERS Indian Health Services (IHS) and Tribal 638 facilities may now enroll as pharmacy providers with KMAP. These types of facilities are not required to obtain a Kansas pharmacy license, but they must meet all applicable standards for licensure. The pharmacist for the facility must have an active pharmacy license, not necessarily from the State of Kansas. LONG-TERM CARE UNITS Hospitals approved by the Kansas Department of Social and Rehabilitation Services (SRS) with long-term care units (LTCUs) may bill for covered drugs dispensed for use by Medicaid beneficiaries. The following guidelines apply only to LTCUs, where automatic stop orders in the acute care area might result in an unreasonable number of billings for drugs used on a continuing basis by LTCU residents. Therapeutic Class Days Supply Payable Antibiotics 7 days Anticoagulants 7 days Narcotics, stimulants, and depressants 7 days Steroids 7 days Other drugs given on an irregular or PRN basis 30 days Drugs given on a continuing maintenance schedule 31 days Injectable drugs normally supplied in single dose ampules 7 days Injectable drugs normally supplied in multiple dose vials vial size • When the quantity of medication ordered by the physician conflicts with the hospital's policy regarding automatic stop orders or maximum dispensing quantities, the days supply guidelines as described previously should be used for billing. • Medication used on a continuing or permanent basis should be billed for a 31-day supply. • When a physician orders a short course of drug therapy, the quantity of medication should be billed on a single claim form. • Billing for medication for LTCU patients must be done monthly or upon discharge of the patient (using the date medication was dispensed rather than date of administration). KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-6 8400. Updated 02/12 MAINTENANCE DRUG ALLOWABLE CRITERIA • Covered drugs designated as “maintenance drugs” by KMAP must be dispensed in a 31-day supply if the physician’s order is written for a 31-day supply or greater. This criteria is for all pharmacy providers, including adult care home providers. • An override is allowed if the beneficiary meets one of the following criteria: o A single unit dispensed, such as DepoProvera® 150 mg, for contraceptive purposes, exceeds a 31-day supply o A child's school requires a separate medication supply o Primary insurance requires more than a 31-day supply AND primary made a payment (If primary payment is identified on the claim, the system will automatically override.) • The allowable override is a value of 02 (other override) in the NCPDP submission clarification override code field. • For web claims, the allowable override is the text option “Other Override” in the Submission Clarification Code field. Providers using the override code must keep written documentation of the reason for use. • Unauthorized reduction of prescription quantities is considered prescription splitting and is not allowed. Schedule II, III, IV, and V drugs are exempt from minimum quantity limitation requirements but should be prescribed and dispensed in reasonable quantities. MAXIMUM ALLOWABLE QUANTITIES No more than a 31-day supply of medication per prescription may be dispensed at one time. MEDICAID • Due to the Omnibus Budget Reconciliation Act (OBRA) of 1990, the Kansas Medicaid Pharmacy Program covers all prescription drugs which are included in the Master Contract Agreement between CMS and the manufacturer, with the exception of exclusions listed in this section. All drugs must be prescribed by licensed practitioners and dispensed by licensed pharmacies, approved dispensing physicians, or approved hospitals. • All claims for covered drugs (including refills) must be substantiated by a prescription from a licensed practitioner. The prescription must be on file at the dispensing pharmacy. NONCOVERED BENEFITS • The beneficiary is allotted money for miscellaneous expenditures within their monthly budget; consequently, some pharmacy items are not covered. The following represent examples of items that are not covered: o APIs and excipients such as bulk drug powders used for compounding o Medical supplies (as determined by FDA) o OTC laxatives and stool softeners o OTC nasal decongestants (pseudoephedrine), proton pump inhibitors, expectorants, cough suppressants, antacids, H2-receptor inhibitors, nasal sprays, ear drops, and eye drops o OTC nutritional supplements such as vitamins and minerals o Routine feminine hygiene products o Topical antiseptic and first aid preparations KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-7 8400. Updated 04/12 NONCOVERED BENEFITS continued • Therapeutic categories of drugs generally not covered are: o DESI less-than-effective drugs and their Identical, Related, and Similar (IRS) drugs o Erectile dysfunction o Cosmetic purposes o Symptomatic relief of cough and colds o Drugs designated by the Secretary of Health and Human Services o Drugs with a manufacturer imposed restricted distribution system which requires the additional purchase of associated tests or services from the manufacturer or its designee o Promotion of fertility o Gender-specific medications if prescribed to the gender for which they are not FDA-approved or medically necessary o Hair growth o Nonlegend (OTC) o Weight reduction with exception of those requiring PA o Weight gain NONDRUG ITEMS Per CMS, any nondrug items as defined by the Food and Drug Administration (FDA) are noncovered under the pharmacy program. These items include medical supplies (such as sodium chloride and water for inhalation), over-the-counter (OTC) nutritional supplements, such as calcium supplements, vitamins and minerals, active pharmaceutical ingredients (APIs) and excipients. These items will also be noncovered for KAN Be Healthy (KBH) participants. NURSING SERVICES REQUIREMENTS FOR IV MEDICATION/NUTRITION • Pharmacy services provided for parenteral administration of total nutritional replacements and intravenous medication in the beneficiary's home require that nursing services from a local home health agency (HHA) is provided. Areas not serviced by a HHA may use the local health department or an advanced registered nurse practitioner. • Postpayment reviews of pharmacy provider charges and reimbursement include verification that required nursing services were provided. OUT-OF-STATE/MAIL ORDER PHARMACY PROVIDERS • Out-of-state/mail order pharmacy providers are permitted limited participation in KMAP. Mail order pharmacy claims which have been reimbursed in part by a third-party payer may be submitted to Medicaid for consideration of coinsurance and deductible when the drug is currently covered through the Kansas Medicaid Pharmacy Program. • Reimbursement will not be considered on these claims unless payment has been made by a third-party payer. OVER-THE-COUNTER ITEMS • Many OTC drugs are not covered for KMAP beneficiaries, including the KBH population. • Examples of noncovered OTC products include: nasal decongestants (pseudoephedrine), proton pump inhibitors, expectorants, cough suppressants, antacids, H 2 -receptor inhibitors, nasal sprays, ear drops, and eye drops. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-8 8400. Updated 04/12 OVER-THE-COUNTER ITEMS continued Note: The prescription-only equivalents of noncovered OTC products that meet the definition of covered, outpatient drugs are covered. • OTC pharmacy products are reviewed on a postpayment basis and included as a component of on-site pharmacy reviews. PARENTERAL & IRRIGATION SOLUTION REIMBURSEMENT All sterile irrigation solutions, large volume parenteral, and small volume parenteral (SVP) fluid replacements for intravenous drug administration are reimbursed the WAC less 40%. PARTIAL FILLS OF C-II DRUGS KMAP will reimburse for partial fills of prescriptions for C-II drugs in accordance with Kansas Pharmacy Regulations (Article 20, Controlled Substances, 68-20-19), for beneficiaries in long-term care facilities or with a medical diagnosis documenting terminal illness, when the claims contain the applicable diagnosis code. To indicate a diagnosis of terminal illness, the ICD-9 diagnosis code V667 must be entered on the pharmacy claim. Note: KMAP does not cover partial fills of prescriptions for C-II drugs when used in circumstances other than those previously mentioned. PER DIEM SERVICES AND SUPPLIES Per diem pharmacy items (over-the-counter) • For over-the-counter items ordered by a prescriber to be taken on a nonscheduled or scheduled basis: o Those ordered on a nonscheduled basis (PRN or as needed) are content of the per diem. o Those ordered on a scheduled basis (designated time) can be submitted to the KMAP pharmacy program for consideration of payment. • Refer to PER DIEM in Section 8400 of the Nursing/Intermediate Care Facility Provider Manual for further information. PHARMACY PRICING • Pharmaceutical items covered by the program are reimbursed at the lesser of the provider's usual and customary (U&C), gross amount due (GAD), or State's reimbursement methodology plus a professional fee. Exceptions to the usual pricing methods apply to certain designated products. • Maximum reimbursement rates designated as maximum allowable costs (MACs), formerly known as federal upper limits (FUL), continue to be established by CMS for various multisource products. • The state maximum allowable cost (SMAC), estimated acquisition cost (EAC), and wholesale-based estimated acquisition cost (WEAC) are predetermined by the State for each covered drug. The EAC reimbursement was based on average wholesale price (AWP) minus a percent based for the service date. • The WEAC reimbursement is now based on the wholesale acquisition cost (WAC) price plus or minus a percentage for the service date. When a WAC, SMAC, or MAC is not on file for the service date, the claim will deny. In these cases, the provider must contact the manufacturer and request the price be provided to First DataBank (FDB). KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-9 8400. Updated 09/11 PHARMACY PRICING continued The following chart lists the EAC reimbursement history for most NDCs. Effective 9/16/2011 Single source @WAC + 4.6% Multisource @WAC - 8.6% Effective 2/18/2003 Single source @ AWP - 13% Multisource @ AWP - 27% Effective 10/1/2002 Single source @ AWP - 11% Multisource @ AWP - 27% Prior to 10/1/2002 AWP - 10% • Pricing Exceptions o Single source reimbursement may be considered for multisource brand name drugs if specific medical necessity criteria are met. Refer to DAW documentation required in Section 8400. o The allowable amount for antihemophilic products is the lesser of the Kansas Department of Health and Environment (KDHE) contract pricing (if applicable) or AWP minus 30% for service dates prior to September 16, 2011, and WAC minus 16% for service dates after September 16. A state-assigned SMAC price may be applicable if KDHE contract pricing is not available or in response to market price changes. o The allowable amount for all sterile irrigation solutions, large volume parenteral (LVP), and small volume parenteral (SVP) fluid replacements for intravenous drug administration are reimbursed at AWP minus 50% for service dates prior to September 16, 2011, and WAC minus 40% for service dates after September 16. Additional pricing exceptions may be added or ended at any time most likely due to changing drug market conditions. • Pricing Resources To ascertain current allowable amounts, providers can use the Automated Voice Response System at 1-800-933-6593. View updated federal and state pricing information using the NDC search feature on the KMAP website. From the home page at https://www.kmap-state-ks.us/, point to Provider, Reference Codes, and then click NDC search or go directly to https://www.kmap-state-ks.us/Provider/PRICING/RefCode.asp. Note: The above pharmacy pricing information is not applicable to Medicare Part D copay assistance claims. Refer to Section 7010 for these claims. PREFERRED DRUG LISTING • The 2002 Legislature passed a law (2002 Session Laws of Kansas, Chapter 180) permitting Kansas Medicaid to implement a preferred drug list (PDL). The Medicaid agency convened an advisory committee of practicing physicians and pharmacists to evaluate drugs in therapeutic drug classes for clinical equivalence and to make recommendations to the agency and to the Drug Utilization Review (DUR) Board. Using a PDL promotes clinically appropriate use of drugs in a cost-effective manner. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-10 8400. Updated 06/12 PREFERRED DRUG LISTING continued • After the PDL Advisory Committee and DUR Board recommendations, and as published in the Kansas Register, new prescriptions for the nonpreferred drugs will require PA. As other therapeutic drug classes are evaluated by the PDL Advisory Committee and the DUR Board, KMAP will publish this information to providers. • The PDL KMAP coverage list(s) and PA request forms can be found on the KDHE website at http://www.kdheks.gov/hcf/pharmacy/default.htm. • When requesting a PA for a nonpreferred drug, a provider much demonstrate at least one of the following: o Medical intolerance to a preferred drug (provide clinical symptoms) o Inadequate response to a preferred drug o Absence of appropriate formulation or indication of the drug (specify) • Xerox State Healthcare, LLC maintains a website providing a formulary and PDL drug search. The SmartFormularySM website provides multiple methods of searching for drugs in the KMAP formulary, along with access to the information related to the formulary and PDL. • The SmartFormulary website can be accessed at: http://www.smartformulary.com/smartformulary/SFHomePage/SFHomePage.aspx?ClientName=KS o The Drug Name search allows the user to search for a complete or partial drug name or to request a list of all drug names beginning with a particular character. o The Therapy Class search allows the user to search for drugs according to their therapeutic classes and sub-classes. o The Clinical Edits/Therapeutic Edits search allows the user to access a PA form for a drug. o The Top 100 search permits the user to see a list of the 100 most-prescribed drugs for selected medical specialties. Use of any search method will allow the user to generate a printable list of the drugs found with all strengths available within the formulary. Links and alerts are available to provide access to other information related to the KMAP formulary, PDL, and pharmacy program. PRIOR AUTHORIZATION • PA ensures medications are provided in a safe, appropriate, and effective manner. All pharmacyrelated PA requests are reviewed using medical necessity criteria established by the DUR Board. • PA requests for pharmacy claims can be initiated at the POS by telephone or fax to one of the following PA departments, depending on the PA need. Xerox Call Center Phone: 1-877-475-7567 Fax: 1-866-246-8512 Hours of operation: Monday - Friday, 7:30 a.m. to 6:30 p.m. Central Standard Time Contact the Xerox Call Center for most medication requests such as: • Nonpreferred/PA required medications • Medications requiring a clinical PA • Medications requiring a PA after exceeding a KMAP limitation, such as many narcotics KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-11 8400. Updated 06/12 PRIOR AUTHORIZATION continued Xerox processes pharmacy-related PAs with a few exceptions. Pharmacies receive a PA determination at the time of billing a claim which will either allow the drug to pay or direct them to contact Xerox if additional information is needed. Xerox operates a PA call center to request authorization not meeting the automated PA criteria. Requests for PA are finalized within 24 hours of receipt. The provider is notified of the outcome after the review is complete. The provider and beneficiary are also notified in writing if a request is denied. HP Prior Authorization Call Center Phone: 1-800-285-4978 or 785-274-5956 (local) Fax: 1-800-913-2229 Hours of operation: Monday - Friday, 7:30 a.m. to 5:30 p.m. Central Standard Time Contact HP for the following PA exceptions: • Hospice medications not covered by the hospice provider • Medication requests related to presumptive eligibility • Noncovered AIDS Drug Assistance Program (ADAP) medications • Medications billed by an out-of-state pharmacy o If related to a Traumatic Brain Injury rehabilitation facility o If a child must stay out-of-state following a transplant • Noncovered medications for a KAN Be Healthy beneficiary • Medications administered in a physician’s office and billed with a procedure code, such as HCPCS Note: For most of these exceptions, pharmacy providers billing at the POS will receive a message to contact HP. The provider is notified of the PA request outcome. The provider and beneficiary are also notified in writing if the request is denied. • For All Pharmacy-Related PAs Some PA requests still require special forms. Forms for drugs that require PA are available at: http://www.kdheks.gov/hcf/pharmacy/pharmacy_druglist_auth_forms.html. For Xerox, the prescriber or dispensing pharmacist (or designee) is responsible for obtaining PA. For HP, the dispensing pharmacist (or designee) is responsible for obtaining PA. Both require the following information at the time of the request: • Name and telephone number of the person calling for PA • Beneficiary's name, date of birth, and KMAP ID number • Prescribing physician's name, address, telephone number, KMAP provider number, and NPI • Name of drug, strength, and quantity of drug requested, as well as the length of therapy and prescribed instructions Note: Sometimes the NDC is also required. • Medical condition or diagnosis substantiating the need for the medication Information is taken by a pharmacy technician or nurse who references criteria developed by the DUR Board. When the information provided meets established criteria, the request will be approved and a PA number will be given by telephone. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-12 8400. Updated 06/12 PRIOR AUTHORIZATION continued When the information obtained clearly does not meet the established criteria, the request will be denied. A denial letter with the reason for the denial will follow the phone notification and should be retained in the provider's files. When the information obtained does not meet the established criteria, but there are extenuating circumstances, or it is questionable whether criteria has been met, the pharmacy consultant will be contacted to review the request. The provider will be notified of the pharmacy consultant's decision. If additional information is needed by the pharmacy consultant before a decision can be made, the pharmacy technician will call the provider to obtain the necessary information. When the pharmacy consultant does not approve the request, the provider will be notified by telephone and informed of the reason for denial. A denial letter will follow the phone notification and should be retained in the provider's files. When the pharmacy consultant approves the request, the provider will be notified by telephone and a PA number will be given. Drug PAs may be approved for varying durations, not to exceed one year, to comply with the intent of specific criteria and dependent upon the information provided. • Emergency Dispensing of PA Medications When a prescription is dispensed that requires PA in an emergency situation or after regular office hours, the pharmacy should call Xerox and leave a message on the voicemail indicating the date, time, beneficiary ID, and medication being dispensed. This will be taken as intent to begin the PA process. If the POS claim returns the HP information for one of the exceptions, the provider can initiate an emergency call to HP. Otherwise, HP and Xerox will transfer any emergency information to the appropriate place. Only a quantity that will provide treatment to the beneficiary until the next business day should be dispensed until PA can be secured. The appropriate PA department will return the telephone message the next working day and process a PA if medical criteria are met. The remainder of the prescription can be dispensed at that time. If PA is denied, only the portion of the medication dispensed emergently during nonworking hours/days will be reimbursed. Refer to Section 4300 in the General Special Requirements Provider Manual for further information regarding PAs. • DAW Documentation Required In order for KMAP to increase patient safety, decrease unnecessary expenditures, and assist in monitoring drug products, if a prescriber specifies dispense as written (DAW) on a drug which has a bioequivalent generic substitute available, the prescriber will be required to fill out the FDA MedWatch form 3500. This MedWatch form must be submitted to the dispensing pharmacy AND also to the FDA. The dispensing pharmacy will then submit this to the KMAP Prior Authorization department for evaluation and receive approval if medical necessity is met. Submitting MedWatch documentation for review: The FDA MedWatch forms can be obtained at http://www.fda.gov/medwatch/getforms.htm. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-13 8400. Updated 06/12 PRIOR AUTHORIZATION continued o Prescribers must mail or fax the completed FDA MedWatch forms to the FDA AND to the dispensing pharmacy. Address MedWatch Fax 1-800-FDA-0178 5600 Fishers Lane Rockville, MD 20852-9787 o Pharmacists must fax the completed FDA MedWatch and PA forms to the KMAP Prior Authorization department for consideration at 1-866-246-8512. o The Prior Authorization department will contact the pharmacy to inform them of the status of the DAW request. o For questions regarding the status of a DAW PA, contact Xerox at 1-877-475-7567. • Criteria to Meet Medical Necessity for a Brand Name Drug When a Bioequivalent Generic Substitute Is Available • Adverse reaction(s) to the generic: Documentation by prescriber that the adverse reaction caused by the generic meets one of the following criteria: o Life threatening o Hospitalization o Disability o Required intervention to prevent impairment or damage OR • Allergic reaction(s) to the generic: Prescriber must document the beneficiary’s experience of an allergic reaction to the generic product of one or more manufacturers. The dates and clinical details with the name of specific companies and the generic versions involved must be included. OR • Therapeutic failure(s) of the generic: Prescriber must document the clinical failure due to beneficiary’s suboptimal drug plasma concentration while taking the generic drug when compared to published full pharmacokinetic profiles for the brand name drug. The term “generic drug” means a drug that is “bioequivalent.” Kansas law refers to the FDA’s definition, which says drugs are bioequivalent if: o They use the same active ingredient as the original version of the drug. The active ingredient is absorbed and available where it is needed in the body at the same rate PRESCRIPTION FILING REQUIREMENT All prescriptions dispensed must be filed in accordance with regulations of the Board of Pharmacy. The records must be kept in such a manner as to allow reasonable ease of audit by agents of KDHE, Division of Health Care Finance (DHCF), appropriate agents of the federal government, or authorized agents of utilization review committees operating under the authority of either state or federal agencies. This requirement applies with equal force to all providers of pharmaceutical services. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-14 8400. Updated 06/12 PROSPECTIVE DRUG UTILIZATION REVIEW • KMAP is required through the Omnibus Budget Reconciliation Act of 1990 (OBRA-90) to have a prospective drug utilization review (ProDUR) program. Drug utilization review is used to help attain the goals set by OBRA-90, which include improving the quality of pharmaceutical care and patient outcomes by encouraging optimal drug use. The ProDUR program requires that the Medicaid pharmacy provider screen for drug therapy problems at point-of-sale or distribution, before each prescription is filled or dispensed. • In compliance with OBRA-90 DUR requirements, pharmacy providers must screen each prescription for certain therapeutic problems using standards consistent with OBRA-90 requirements. The pharmacy provider’s ProDUR program must be based upon predetermined standards, consistent with the compendia. • OBRA requires: o A pharmacist using his or her professional judgment shall review the beneficiary’s entire pharmacy record and each prescription drug order presented for dispensing for the purpose of promoting therapeutic appropriateness by identifying the following: Over and under utilization Therapeutic duplication Drug-disease contraindications Drug-drug contraindications Incorrect drug dosage or duration of drug treatment Drug allergies Clinical abuse/misuse o Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the prescriber. • Providers can receive additional ProDUR information provided by the KMAP POS system. These alerts are supplemental to those required by law to be performed by the pharmacy provider and not in lieu of those alerts. KMAP ProDUR takes an incoming pharmacy claim and sends it through certain checks within the KMAP pharmacy system to determine if any potential problems exist. Supplemental alert information can then be returned to the provider. The provider should evaluate any ProDUR information that is returned with a claim and intervene appropriately. • KMAP has ProDUR alerts that pay-but-report and auto-deny claims. The pay-but-report alert pays the claim and sends alert information to the pharmacy. The auto-deny alert denies the claim and returns alert information to the pharmacy. For purposes of simplification, only the auto-deny DUR alerts are discussed in the DUR ALERTS portion of Section 8400 in this manual. A list of the pay-but-report alerts can be obtained by contacting KMAP Customer Service. REFILLS • A refill may only be provided when specifically ordered by the practitioner. A prescription may be refilled in accordance with applicable federal and state laws up to one year from date of issue for noncontrolled drugs, after which time a new prescription must be obtained. Refills on controlled substances are limited by applicable federal and state laws. • The refill date and the initials of the dispensing pharmacist must be recorded on the patient record or on the front or back of the prescription for all refills. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-15 8400. Updated 10/11 SINGLE-SOURCE PRESCRIPTION CLAIM LIMITATIONS • There is a limit of four single-source prescription drug claims allowed per beneficiary per calendar month. The following are excluded from the limit edit: o KBH beneficiaries o Antiretroviral drugs o State-specified preferred drugs only on the PDL o State-specified anti-rejection drugs used for transplant patients o State-specified anti-emetics o State-specified chemotherapy drugs o Interferons o Immune globulins o Antihemophilic drugs o Most drugs used to treat mental illness o All covered contraceptives Note: All prescriptions for insulin will price as single-source but may or may not be counted as multi-source for this policy. Note: PRESCRIPTION LIMIT OVERRIDE CRITERIA Pharmacists should submit the prescription limit override code only if both of the following are met: o Medical necessity has been obtained from the physician. o The monthly prescription limit of four single-source claims per month has been met. • If a beneficiary meets the preceding criteria, the pharmacy provider should enter a value of "07" (Medical Necessary) in the NCPDP Submission Clarification Override Code field. For Internet claims, the allowable override is the text option “Medically Necessary” in the Submission Clarification Code field. Documentation of the medical necessity must be kept. • Pharmacists must not use the override code for a prescription until after the monthly prescription limit has been reached and medical necessity has been shown. Pharmacists will be audited for appropriate utilization of the prescription limit override code. • A single-source prescription claims per calendar month limit has been in effect since April 1, 2003. Below are several clarifications for providers: o Documentation of medical necessity is good for up to six months. o Document the information on the back of the prescription or use any other means of documenting the medical necessity information. o A provider can use one form documenting medical necessity for several of a beneficiary’s scheduled medications. If a new single-source prescription claim is requested and denies for this edit, the provider must get medical necessity documentation. KEEP IN MIND the blanket form with ‘Medical Necessity’ can be used ONLY for the beneficiary’s regularly scheduled medications. o Any time a single-source prescription claim is filled for a beneficiary within the same calendar month, regardless of whether or not it is a refill, it will count towards the limitation. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-16 8400. Updated 09/11 SINGLE-SOURCE PRESCRIPTION CLAIM LIMITATIONS continued o The NCPDP Reject Code that appears when reaching this limit is “76” or “Plan Limitations Exceeded.” o Providers submitting claims on paper must document the medical necessity override code in the Remarks section (field 16) on the paper claim form. The provider must link the line number to the code. o Providers submitting via EMC may only resolve this edit issue via a paper claim form or POS or web. o There is NOT a list of NDCs considered single-source, multi-source or excluded. Providers can use the KMAP website at https://www.kmap-state-ks.us/ to validate coverage. NDC coverage can be verified under the Provider menu item by choosing Reference Codes then NDC Search. Customer Service can also provide coverage information at 1-800-933-6593 (Monday through Friday, from 8:00 a.m. until 5:00 p.m.). o NDCs may move back and forth between single-source, multi-source, and excluded at any time. TAMPER-RESISTANT PRESCRIPTIONS • All written, nonelectronic prescriptions for outpatient drugs for KMAP beneficiaries must be written on tamper-resistant pads or paper, as required in Section 1903(i)(23) of the Social Security Act; 42 U.S.C. Sec. 1396b(i)(23). • CMS Requirements of a Tamper-Resistant Prescription Pad or Paper Written prescriptions for KMAP beneficiaries must have all three of the following requirements to be considered tamper-resistant. o One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form o One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber o One or more industry-recognized features designed to prevent the use of counterfeit prescription forms Prescriptions exempt from the tamper-resistant requirements include the following: o Electronic, faxed, or verbal prescriptions o Prescriptions covered by a managed care entity o Medications dispensed directly to patients by the prescribing provider o In most situations when drugs are provided in certain institutional and clinical facilities • Clarification for Specific Situations Emergency Filling A pharmacy may fill a prescription on an emergency basis and dispense the full prescription to the patient only if the pharmacy obtains a compliant prescription in writing or via telephone, fax, or e-prescription within 72 hours. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-17 8400. Updated 09/11 TAMPER-RESISTANT PRESCRIPTIONS continued Institutional Setting A prescription is considered “tamper-resistant” when a written order is prepared in an institutional setting, and all of the three following requirements have been met: • The doctor or medical assistant writes the order into the medical record. • The order is given by medical staff directly to the pharmacy. • The patient never has the opportunity to handle the written order. Controlled Substances Federal and Kansas laws require all Schedule II controlled substance prescriptions to be written. If a nontamper resistant Schedule II controlled substance prescription is presented to a pharmacy and is compliant with federal and Kansas laws, then the prescription can be considered tamper-resistant through telephone, fax, or e-prescription verification. Prescription Transfer When a prescription for a KMAP beneficiary is transferred from one pharmacy to another, the pharmacy receiving the prescription must verify with the original pharmacy that the prescription met the tamper-resistant requirements. This verification can be done by telephone or fax. The receiving pharmacy does not need to obtain direct confirmation from the prescribing provider. Compliance The primary responsibility for auditing KMAP providers rests with KDHE-DHCF. However, there are some circumstances in which CMS, the Office of the Inspector General of the U.S. Department of Health and Human Services, or some other federal agency may have occasion to audit a pharmacy provider. When this occurs, the federal agency will have the authority to determine compliance with the tamper-resistant requirements. Retroactive Eligibility When a KMAP beneficiary is retroactively eligible, the previously filled prescriptions will be considered tamper-resistant. Any future original or refill prescriptions must be tamper-resistant. Refills on Prescriptions Dated Prior to April 1, 2008 If the original prescription was dated and presented to the pharmacy prior to April 1, 2008, then the prescription and its refills do not have to be tamper-resistant. TELEPHONE PRESCRIPTIONS Telephoned prescriptions, when allowed by applicable federal and state laws and promptly reduced to writing, are acceptable; however, the signature/initials of the pharmacist receiving the prescription must be indicated on the prescription. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-18 8400. Updated 04/12 DRUG BENEFIT LIMITATIONS When a diagnosis is applicable, the pharmacy must contact the prescribing provider if no diagnosis is noted on the prescription. The pharmacy must maintain documentation of physician-supplied diagnosis and contact information in the prescription records. Amphetamines, Amphetamine Mixtures, and Amphetamine-Like Drugs Amphetamines, amphetamine mixtures, and amphetamine-like drugs require an ICD-9 diagnosis code to be entered on the claim. Applicable diagnoses, with the exception of lisdexamfetamine (Vyvanse®), are: • 31400 – Attention deficit disorder without mention of hyperactivity • 31401 – Attention deficit disorder with hyperactivity • 34700 – Narcolepsy without cataplexy • 34701 – Narcolepsy with cataplexy • 34710 – Narcolepsy in conditions classified elsewhere without cataplexy • 34711 – Narcolepsy in conditions classified elsewhere with cataplexy • 79951 – Attention or concentration deficit Applicable diagnoses for lisdexamfetamine (Vyvanse®) are: • 31400 – Attention deficit disorder without mention of hyperactivity • 31401 – Attention deficit disorder with hyperactivity • 79951 – Attention or concentration deficit Note: KMAP does not cover amphetamines, amphetamine mixtures, and amphetamine-like drugs when used to treat diagnoses other than the ones listed above. Antitubercular Antibiotics Antitubercular drugs are noncovered. They are covered free of charge through local health departments. Use of antitubercular drugs for conditions other than tuberculosis requires PA. Armodafinil Armodafinil (Nuvigil®) is covered for the diagnosis of cataplexy, narcolepsy, unspecified sleep apnea, and circadian rhythm sleep disorder of nonorganic origin. Coverage is restricted to the following diagnosis codes: • 30745 – Circadian rhythm sleep disorder of nonorganic origin • 32723 – Obstructive sleep apnea (adult and pediatric) • 32736 – Circadian rhythm sleep disorder, shift work • 34700 – Narcolepsy without cataplexy • 34701 – Narcolepsy with cataplexy • 34710 – Narcolepsy in conditions classified elsewhere without cataplexy • 34711 – Narcolepsy in conditions classified elsewhere with cataplexy • 78057 – Unspecified sleep apnea The pharmacy must verify the diagnosis with the prescribing provider and maintain documentation of contact in prescription records. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-19 8400. Updated 06/12 Benzodiazepines The daily limits on benzodiazepines are as follows: Alprazolam (Xanax®) – 120 mg/30 days Diazepam (Valium®) – 1200 mg/30 days Clorazepate (Tranxene®) – 2700 mg/30 days Temazepam (Restoril®) – 900 mg/30 days Lorazepam (Ativan®) – 180 mg/30 days Note: Xanax XR® (alprazolam), Tranxene SD® (clorazepate) and Niravam® (alprazolam) are excluded from benzodiazepine coverage. Coverage of new benzodiazepine products will be determined by KMAP. Buprenorphine/Naloxone and Buprenorphine Buprenorphine/naloxone (Suboxone®) and buprenorphine (Subutex®) require PA. Daily dosing is not to exceed 40 mg per day. Butorphanol Butorphanol claims in excess of 12.5 units per calendar month will be denied. (One spray pump equals 2.5 cc or 2.5 billing units.) C1 Esterase Inhibitor [Human] C1 esterase inhibitor [human] (Cinryze®) is covered for the diagnosis of hereditary angioedema only. The acceptable ICD-9 code is 2776. KMAP does not cover Cinryze when used to treat diagnoses other than the above mentioned. The pharmacy must verify the diagnosis with the prescribing provider and maintain documentation of contact in prescription records. Carisoprodol Carisoprodol-containing products (such as Soma®) are restricted to the maximum recommended dose of 29,400 mg in a 21-day period and a 21-day supply per year. Additionally, PA is required for amounts of carisoprodol-containing products beyond the initial 21-day supply per year limit. Clobazam An ICD-9-CM diagnosis code is required on all clobazam (Onfi®) claims. KMAP does not cover clobazam when used to treat any diagnoses other than those listed below. The pharmacy must verify the diagnosis with the prescribing provider and maintain documentation of contact in the prescription records. Clobazam is only covered for the following conditions or diagnoses. Epilepsy: For a diagnosis of epilepsy, submit the most appropriate one of the following diagnosis codes. (KMAP will accept 34500 for epilepsy diagnoses within the range of 34500 to 34591.) • 34500 – Generalized nonconvulsive epilepsy without mention of intractable epilepsy • 34501 – Generalized nonconvulsive epilepsy with intractable epilepsy • 34510 – Generalized convulsive epilepsy without mention of intractable epilepsy • 34511 – Generalized convulsive epilepsy with intractable epilepsy • 3452 – Generalized convulsive epilepsy, petit mal status • 3453 – Generalized convulsive epilepsy, grand mal status • 34540 – Partial epilepsy, with impairment of consciousness without mention of intractable epilepsy KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-20 8400. Updated 08/12 • • • • • • • • • • • • • • 34541 – Partial epilepsy, with impairment of consciousness with intractable epilepsy 34550 – Partial epilepsy, without mention of impairment of consciousness without mention of intractable epilepsy 34551 – Partial epilepsy, without mention of impairment of consciousness with intractable epilepsy 34560 – Infantile spasms without mention of intractable epilepsy 34561 – Infantile spasms with intractable epilepsy 34570 – Epilepsia partialis continua without mention of intractable epilepsy 34571 – Epilepsia partialis continua with intractable epilepsy 34580 – Other forms of epilepsy without mention of intractable epilepsy 34581 – Other forms of epilepsy with intractable epilepsy 34590 – Epilepsy, unspecified without mention of intractable epilepsy 34591 – Epilepsy, unspecified with intractable epilepsy 78033 – Post-traumatic seizures 78039 – Other convulsions 9070 – Epilepsy due to late effects of intracranial injury Eltrombopag Eltrombopag (Promacta®) is only covered for chronic immune (idiopathic) thrombocytopenia purpura (ITP). Coverage is restricted to diagnosis codes 28731 (immune thrombocytopenic purpura) and 28733 (congenital and hereditary thrombocytopenic purpura). The pharmacy must verify the diagnosis with the prescribing provider and maintain documentation of contact in prescription records. Fentanyl Citrate • Sublingual Tablets (Abstral®) Abstral (fentanyl citrate sublingual) tablets require a clinical PA and are restricted to beneficiaries 18 years of age and older. Abstral will continue to be limited to four units per day. • Sublingual Spray Fentanyl sublingual spray (such as Subsys®) requires PA and is restricted to beneficiaries 18 years of age and older. In addition, it is limited to eight units a day. • Transmucosal Systems Fentanyl citrate transmucosal systems, such as lozenges (Actiq®) and buccal formulations (Fentora®, Onsolis®), require PA. The PA criteria includes a daily quantity limit of four units per day. Gabapentin An ICD-9-CM diagnosis code is required on all gabapentin (Neurontin®) claims. The pharmacy will need to contact the prescribing provider if no diagnosis is noted on the prescription. Gabapentin is only covered for the following conditions or diagnoses listed below: • Neuropathic pain: for a diagnosis indicating neuropathic pain, submit diagnosis code 3569 KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-21 8400. Updated 08/12 • Epilepsy: for a diagnosis of epilepsy, submit the most appropriate one of the following diagnosis codes (KMAP will accept 34500 for epilepsy diagnoses within the range of 34500 to 34591.) o 34500 – Generalized nonconvulsive epilepsy without mention of intractable epilepsy o 34501 – Generalized nonconvulsive epilepsy with intractable epilepsy o 34510 – Generalized convulsive epilepsy without mention of intractable epilepsy o 34511 – Generalized convulsive epilepsy with intractable epilepsy o 3452 – Generalized convulsive epilepsy, petit mal status o 3453 – Generalized convulsive epilepsy, grand mal status o 34540 – Partial epilepsy, with impairment of consciousness without mention of intractable epilepsy o 34541 – Partial epilepsy, with impairment of consciousness with intractable epilepsy o 34550 – Partial epilepsy, without mention of impairment of consciousness without mention of intractable epilepsy o 34551 – Partial epilepsy, without mention of impairment of consciousness with intractable epilepsy o 34560 – Infantile spasms without mention of intractable epilepsy o 34561 – Infantile spasms with intractable epilepsy o 34570 – Epilepsia partialis continua without mention of intractable epilepsy o 34571 – Epilepsia partialis continua with intractable epilepsy o 34580 – Other forms of epilepsy without mention of intractable epilepsy o 34581 – Other forms of epilepsy with intractable epilepsy o 34590 – Epilepsy, unspecified without mention of intractable epilepsy o 34591 – Epilepsy, unspecified with intractable epilepsy o 78033 – Post-traumatic seizures o 78039 – Other convulsions o 9070 – Epilepsy due to late effects of intracranial injury Influenza Treatment Prescription drug claims for neuraminidase inhibitors zanamivir (Relenza®) and oseltamivir (Tamiflu®) will be paid for dates of service during the influenza (flu) season only (October 1 through April 30). According to KDHE, the Centers for Disease Control consider the flu season in Kansas to be from mid-October through mid-April. Ketorolac Products (such as Toradol® and Sprix®) Claims submitted for greater than a five-day supply will be denied. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-22 8400. Updated 06/12 Leuprolide Acetate Leuprolide acetate (Eligard®, Lupron® products) requires an ICD-9 diagnosis code to be entered on the claim. Leuprolide acetate is only covered for the following diagnosis codes: • 1740 – Malignant neoplasm of nipple and areola of female breast • 1741 – Malignant neoplasm of central portion of female breast • 1742 – Malignant neoplasm of upper-inner quadrant of female breast • 1743 – Malignant neoplasm of lower-inner quadrant of female breast • 1744 – Malignant neoplasm of upper-outer quadrant of female breast • 1745 – Malignant neoplasm of lower-outer quadrant of female breast • 1746 – Malignant neoplasm of axillary tail of female breast • 1748 – Malignant neoplasm of other specified sites of female breast • 1749 – Malignant neoplasm of breast (female), unspecified site • 1750 – Malignant neoplasm of nipple and areola of male breast • 1759 – Malignant neoplasm of other unspecified sites of male breast • 1830 – Malignant neoplasm of ovary • 185 – Malignant neoplasm of prostate • 1986 – Secondary malignant neoplasm of ovary • 19881 – Secondary malignant neoplasm of other specified sites • 19882 – Secondary malignant neoplasm of genital organs • 217 – Benign neoplasm of breast • 2180 – Submucous leiomyoma of uterus • 2181 – Intramural leiomyoma of uterus • 2182 – Subserous leiomyoma of uterus • 2189 – Leiomyoma of uterus, unspecified • 220 – Benign neoplasm of ovary • 2222 – Benign neoplasm of prostate • 2330 – Carcinoma in situ of breast • 23339 – Carcinoma in situ, other female genital organ • 2334 – Carcinoma in situ of prostate • 2383 – Neoplasm of uncertain behavior of breast • 2393 – Neoplasm of unspecified nature of breast • 2591 – Precocious sexual development and puberty, not elsewhere classified • 6170 – Endometriosis of uterus • 6171 – Endometriosis of ovary • 6172 – Endometriosis of fallopian tube • 6173 – Endometriosis of pelvic peritoneum • 6174 – Endometriosis of rectovaginal septum and vagina • 6175 – Endometriosis of intestine • 6176 – Endometriosis in scar of skin • 6178 – Endometriosis of other specified sites • 6254 – Premenstrual tension syndromes • 6259 – Unspecified symptom associated with female genital organs KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-23 8400. Updated 04/12 Leuprolide Acetate Pediatric Products Pediatric leuprolide acetate (Lupron Depot-PED® products) is restricted to beneficiaries 12 years of age and younger with a physician-assigned diagnosis code of 2591 (precocious sexual development and puberty, not elsewhere classified). Modafinil Modafinil (Provigil®) is covered for the following diagnoses and ICD-9 codes: • 30745 – Circadian rhythm sleep disorder of nonorganic origin • 32723 – Obstructive sleep apnea (adult and pediatric) • 32736 – Circadian rhythm sleep disorder, shift work • 34700 – Narcolepsy without cataplexy • 34701 – Narcolepsy with cataplexy • 34710 – Narcolepsy in conditions classified elsewhere without cataplexy • 34711 – Narcolepsy in conditions classified elsewhere with cataplexy • 78057 – Unspecified sleep apnea Note: KMAP does not cover modafinil (Provigil) when used to treat diagnoses other than those previously mentioned. Nabilone Nabilone (Cesamet®) requires PA. Dosing is limited to no more than 30 capsules or tablets per claim. PA does not override this quantity restriction. Narcotic Analgesics, Tramadol, and Skeletal Muscle Relaxants Medicaid will not reimburse drug claims that exceed maximum recommended dosing during any 30-day period for scheduled narcotic analgesics, narcotic analgesic combination products, tramadol, and skeletal muscle relaxants. For medically necessary conditions which require more than the maximum approved dosage, the dose may be approved through the PA process. The claim must be supported with documentation in the beneficiary's medical records. Medications included are: • Acetaminophen, aspirin, or ibuprofen combination products containing any of the following: butalbital, codeine, dihydrocodone, hydrocodone, oxycodone, entazocine, or tramadol (also included are single ingredient narcotic analgesic and skeletal muscle relaxant products) • Carisoprodol-containing products (such as Soma®), cyclobenzaprine (Flexeril®), metaxalone (Skelaxin®), methocarbamol (Robaxin®), orphenadrine (Norflex®), tizanidine (Zanaflex®) • Hydromorphone (Dilaudid®) • Meperidine (Demerol®) • Methadone (Methadose®) • Narcotic agonist/antagonist combinations of pentazocine (Talwin NX®, Talwin Compound®, Talacen®) • Tramadol (Ultram®) • Oxycodone (Oxycontin®) KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-24 8400. Updated 06/12 Opioids Dose Optimization (Long-Acting) Dose optimization limits apply to many brand and generic long-acting opioids. This limits the quantity of units for each drug strength reimbursed per day. These limitations cannot be overridden by PA. There is not a limitation on the total quantity of each medication; if multiple strengths of a single medication are prescribed, the allowed number of units per day are available for each strength. The table below provides limitations which apply to all but the highest strength. Generic Brand Examples Allowed Number of Units per Day of Each Drug Strength Buprenorphine transdermal patch Butrans® 1 patch/7 days Fentanyl transdermal patch Duragesic® 1 patch/2 days Hydromorphone HCI tablet Exalgo® 1 tablet/day Morphine sulfate capsule Kadian® 2 capsules/day Morphine sulfate capsule Avinza® 1 capsule/day Morphine sulfate tablet MS Contin® & Oramorph SR® 3 tablets/day Morphine sulfate/naltrexone capsule Embeda® 2 capsules/day Oxycodone HCI tablet OxyContin® 3 tablets/day Oxymorphone HCI tablet Opana ER® 2 tablets/day Tapentadol HCI tablets Nucynta ER® 2 tablets/day Tramadol HCI tablet Ryzolt® 1 tablet/day Tramadol HCI tablet Ultram ER® 1 tablet/day Cumulative monthly quantity restrictions were placed on many of the brand and generic long-acting opioids listed in the previous table. These restrictions limit the total quantity dispensed of multiple strengths of a single medication per month. Claims exceeding these limitations will be denied, unless approved in advance through the PA process. For any changes made to the prescription permitted by pharmacy law, pharmacists must always document, with their initials, the time and date when the prescriber or prescriber’s agent is contacted. This documentation must be available upon request. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-25 8400. Updated 04/12 Pregabalin An ICD-9-CM diagnosis code is required on all pregabalin (Lyrica) claims. The pharmacy will need to contact the prescribing provider if no diagnosis is noted on the prescription. Pregabalin is only covered for the following conditions or diagnoses: • Neuropathic pain: for a diagnosis indicating neuropathic pain, submit diagnosis code 3569 • Epilepsy: for a diagnosis of epilepsy, submit the most appropriate one of the following diagnosis codes (KMAP will accept 34500 for epilepsy diagnoses within the range of 34500 to 34591): o 34500 – generalized nonconvulsive epilepsy without mention of intractable epilepsy o 34501 – generalized nonconvulsive epilepsy with intractable epilepsy o 34510 – generalized convulsive epilepsy without mention of intractable epilepsy o 34511 – generalized convulsive epilepsy with intractable epilepsy o 3452 – generalized convulsive epilepsy, petit mal status o 3453 – generalized convulsive epilepsy, grand mal status o 34540 – partial epilepsy, with impairment of consciousness without mention of intractable epilepsy o 34541 – partial epilepsy, with impairment of consciousness with intractable epilepsy o 34550 – partial epilepsy, without mention of impairment of consciousness without mention of intractable epilepsy o 34551 – partial epilepsy, without mention of impairment of consciousness with intractable epilepsy o 34560 – infantile spasms without mention of intractable epilepsy o 34561 – infantile spasms with intractable epilepsy o 34570 – epilepsia partialis continua without mention of intractable epilepsy o 34571 – epilepsia partialis continua with intractable epilepsy o 34580 – other forms of epilepsy without mention of intractable epilepsy o 34581 – other forms of epilepsy wit intractable epilepsy o 34590 – epilepsy, unspecified without mention of intractable epilepsy o 34591 – epilepsy, unspecified with intractable epilepsy o 78033 – post-traumatic seizures o 78039 – other convulsions o 9070 – epilepsy due to late effects of intracranial injury • Fibromyalgia: for a diagnosis of fibromyalgia, submit diagnosis code 7291 In addition to the diagnosis requirement, pregabalin (Lyrica) is only covered for ages 18 and older. Dosage is not to exceed 600 mg per day or 18,600 mg in a 31-day period. The 600 mg per day limitation can be overridden by obtaining PA if criteria has been met. Pregabalin (Lyrica) claims will be denied if the following units (capsules) per day are exceeded: • 300 mg capsules: two units (capsules) per day • 225 mg capsules: two units (capsules) per day • 200 mg capsules: three units (capsules) per day • 150 mg capsules: three units (capsules) per day KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-26 8400. Updated 04/12 • 100 mg capsules: three units (capsules) per day • 75 mg capsules: three units (capsules) per day • 50 mg capsules: three units (capsules) per day • 25 mg capsules: three units (capsules) per day Note: PA will not override the unit (capsule) limit per day. Prenatal Vitamins Legend prenatal vitamins are covered for pregnant women only and up to three months postpartum for lactating women. To indicate a condition of pregnancy or that of a lactating woman for up to three months postpartum, submit a diagnosis code of 650. Note: KMAP does not cover prenatal vitamins when used to treat diagnoses other than those previously mentioned. Promethazine (Phenergan) Due to the potential for causing fatal respiratory depression in children younger than two years of age, products containing promethazine (Phenergan®) are not covered for beneficiaries younger than age two. Proton Pump Inhibitor (PPI) Drugs PA is required for PPI drug quantities exceeding one dosage unit (tablets, capsules, and so forth) per day for greater than 60 days of drug therapy within a rolling 365-day period. This limitation applies to oral and IV dosage forms of the following PPI drugs: • Lansoprazole (Prevacid®, Prevacid NapraPAC®) • Esomeprazole (Nexium®) • Omeprazole (Prilosec®, Zegerid®) • Rabeprazole (Aciphex®) • Pantoprazole (Protonix®) • Dexlansoprazole (Dexilant® formerly known as Kapidex®) One of the following conditions is required for PA approval: • Treatment of erosive esophagitis/Barrett’s esophagus • Maintenance of healing erosive esophagitis • Treatment of pathological hypersecretory conditions, such as Zollinger-Ellison syndrome • Treatment of NSAID-associated gastric ulcer in beneficiaries who continue NSAID use (gastric ulcer induced by previous NSAID usage) • Reduction of the risk of gastric ulcers by continuing the use of NSAID therapy in beneficiaries with a documented history of gastric ulcer Note: The claim denial message to the dispensing pharmacy will indicate “Prior Authorization Required.” This limitation does not change the current PDL process. Some PPI drugs are nonpreferred and require PA for coverage at any dosage or length of treatment. For nonpreferred PPI drugs exceeding the above limitation, one PA is required for coverage and another PA is required to exceed one dosage unit per day for greater than 60 days within a rolling 365-day period. For preferred PPI drugs, PA is not required for coverage unless this limitation is exceeded. Any combination of more than 124 units of PPIs per month (or four per day) will be denied. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-27 8400. Updated 04/12 Note: Even when PA is issued for a nonpreferred PPI or to allow more than one dosage unit per day, a maximum of 124 dosage units of any combination of PPIs still applies. Sildenafil Citrate An ICD-9-CM diagnosis code is required on all sildenafil citrate (Revatio®) claims. The pharmacy will need to contact the prescribing provider if no diagnosis is noted on the prescription. KMAP covers Revatio only when used to treat the following conditions or diagnoses: • Pulmonary hypertension, primary, essential or idiopathic: for a diagnosis indicating primary, essential, or idiopathic pulmonary hypertension, submit diagnosis code 4160 • Pulmonary hypertension, secondary: for a diagnosis indicating secondary pulmonary hypertension, submit diagnosis code 4168 Sleep Aids The following limitations apply to zolpidem (Ambien®, Ambien CR®), zaleplon (Sonata®), eszopiclone (Lunesta®) and ramelteon (Rozerem®): • No more than 31 tablets/capsules of any combination of the following are allowed per 31 days: o All strengths of zolpidem (Ambien and Ambien CR) o All strengths of eszopiclone (Lunesta) o Zaleplon (Sonata) 5 mg capsules o Zaleplon (Sonata) 10 mg capsules continue to be restricted to no more than 62 capsules per 31 days • No more than a 31-day supply of any combination of the following is allowed per 31 days: o All strengths of zolpidem (Ambien and Ambien CR) o All strengths of eszopiclone (Lunesta) o All strengths of zaleplon (Sonata) o No more than 31 ramelteon (Rozerem) tablets per 31 days o Zaleplon (Sonata) 10 mg capsules, no more than 62 capsules per 31 days In addition, claims will be denied if the following units (tablets or capsules) per day are exceeded: • All strengths of zolpidem (Ambien and Ambien CR): one tablet per day • All strengths of eszopiclone (Lunesta): one tablet per day • Zaleplon (Sonata) 5 mg: one capsule per day • Zaleplon (Sonata) 10 mg: two capsules per day • All strengths of ramelteon (Rozerem): one tablet per day Note: The above restrictions cannot be overridden with PA. New zolpidem, zaleplon, eszopiclone and ramelteon products (for different strengths, dose ormulations, or by different manufacturers) are subject to similar limitations as those described previously. In addition to the restrictions noted, drugs for insomnia that are nonpreferred continue to require PA. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-28 8400. Updated 06/12 Smoking Cessation Products KMAP provides coverage for nicotine patches and bupropion SR (Zyban®). The medication coverage is limited to a maximum of one 12-week course of therapy per 365 days based upon the manufacturers’ recommended dosing. Nicotine gum, nicotine oral, and nasal inhalers are not covered. KMAP also provides coverage for varenicline (Chantix®). Chantix coverage is limited to 24 weeks of therapy per 365 days. In addition, the following restrictions are in place: • Starter packs are not to be dispensed at the same time as nonstarter packs and individual tablets. (Beneficiaries must complete the majority of any previous prescription before the next prescription will be reimbursed.) • Claims exceeding a daily quantity of two tablets will be denied. Tadalafil Tadalafil (Adcirca®) is covered for the diagnosis of pulmonary hypertension (primary, essential, or idiopathic) and pulmonary hypertension (secondary). The acceptable ICD-9 codes are 4160 (pulmonary hypertension [primary, essential, or idiopathic]) and 4168 (pulmonary hypertension [secondary]). Tapentadol Tapentadol (such as Nucynta®) is limited to no more than 18,100 mg within a 30-day period. Claims exceeding this limitation will be denied. PA will not override this limitation. Tramadol/Acetaminophen Tramadol hydrochloride/acetaminophen (Ultracet®) is limited to no more than 40 tablets per 31 days. In addition, the daily quantity is not to exceed eight tablets. Claims exceeding these limitations are denied. PA will not override these restrictions. Triptans Any combination of triptans in excess of 18 units in a 31-day period is denied. KANSAS MEDICAL ASSISTANCE PROGRAM PHARMACY PROVIDER MANUAL BENEFITS & LIMITATIONS 8-29 APPENDIX I NCPDP REJECT CODE 05 (M/I Pharmacy Number) 07 (M/I Cardholder ID Number) 13 (M/I Other Coverage Code) 15 (M/I Date Of Service) 16 (M/I Prescription/Service Reference Number) 17 (M/I Fill Number) 19 (M/I Days Supply) 21 (M/I Product/Service ID) 25 (M/I Prescriber ID) 28 (M/I Date Prescription Written) 39 (M/I Diagnosis Code) REASON CLAIM REJECTED 1. Billing provider ID number missing/invalid 2. Billing provider location code missing/invalid 3. Billing provider ID submitted under old format 1. Beneficiary ID number missing/invalid 2. Beneficiary ID number not on file 1. Other Coverage Code missing/invalid 1. Dispense date missing/invalid 1. Prescription number missing 1. Refill indicator invalid 1. Estimated days supply missing/invalid 1. Drug code (NDC) missing/invalid 1. Prescribing provider ID number missing 1. Date prescribed missing/invalid 1. Diagnosis code entered on claim is invalid 2. Diagnosis code entered on claim is not on file 3. Diagnosis code entered on claim is inactive for date of service 40 (Pharmacy Not Contracted With Plan On Date Of Service) 41 (Submit Bill To Other Processor Or Primary Payer) 1. Billing provider ID number not on file 2. Billing provider not eligible to bill on date of service 1. Healthwave service must be billed by Managed Care Organization (MCO) 2. Other provider is responsible for billing service to beneficiary assigned to P.A.C.E. program 52 (Non-Matched Cardholder ID) 54 (Non-Matched Product/Service ID Number) 1. Beneficiary name/ID number/birth date mismatch 1. NDC not on file 2. NDC not effective for date of service 1. Prescribing provider’s DEA number is not on the KMAP DEA file or is inactive. 1. NDC not covered for beneficiary's age 1. NDC not covered for beneficiary's gender 56 (Non-Matched Provider ID) 60 (Product/Service Not Covered For Patient Age) 61 (Product/Service Not Covered For Patient Gender) 62 (Patient/Cardholder ID Name Mismatch) 65 (Patient Is Not Covered) 67 (Filled Before Coverage Effective) 70 (Product/Service Not Covered) 73 (Refills Are Not Covered) 74 (Other Carrier Payment Meets Or Exceeds Payable) 1. Beneficiary name missing 2. Beneficiary name/ID number mismatch 1. Beneficiary is ineligible for date of service billed 2. Beneficiary's benefit plan is invalid for service billed 1. No pricing segment on file for date of service billed 1. NDC is not covered by Medicaid 2. NDC is not covered for MediKan beneficiaries 3. NDC is not covered due to DESI value of 5 or 6 (Less Than Effective rating) 4. KBH participant - Pre-Determination not obtained on non-covered NDC 5. Medical supply NDC is not covered 1. Prescriptions for Schedule II drugs cannot be refilled 1. Third party payment amount is greater than the claim total charge AI- 1 APPENDIX I NCPDP REJECT CODE REASON CLAIM REJECTED 75 (Prior Authorization Required) 1. NDC requires prior authorization (non-preferred drug) 2. Prior authorization required for out-of-state providers 3. NDC requires prior authorization (not related to preferred drug list) 4. Prior authorization required for hospice beneficiary 5. Dosage exceeds the maximum recommendation on various narcotic, narcotic combination, skeletal muscle relaxant & tramadol products and prior authorization is required to exceed the limitation 76 (Plan Limitations Exceeded) 1. Quantity dispensed is greater than maximum allowed 2. Schedule III & IV drugs are limited to one initial fill and 5 refills 3. Limit of 4 impotence tablets per month exceeded 4. Limit of 84 units of nicotine patches per 365 days exceeded 5. Limit of 168 oral smoking cessation units per 365 days exceeded 6. Limit of 15 units of butorphanol nasal spray (5 nasal spray packages) per month exceeded 7. Zanamivir inhalation limit of 20 per flu season exceeded 8. Osteltamivir suspension limit of 75ml per flu season exceeded 9. Osteltamivir capsules limit of 10 per flu season exceeded 10. Limit of 4 single source prescription claims per month exceeded 11. Limit of one 5-day course of ketorolac treatment within a 30-day period exceeded 12. Limit of 18 units of any triptan product per 31 days exceeded. 77 (Discontinued Product/Service ID Number) 80 (Drug-Diagnosis Mismatch) 1. NDC is obsolete or has been terminated 1. NDC requires a diagnosis and diagnosis code is missing or invalid 2. NDC is not covered for the diagnosis billed 1. Claim is past the filing limit 1. Dispense date on the claim is after the billing date 1. Claim is an exact duplicate of a paid claim or a claim in process 1. Internal error 2. Provider terminated from Medicaid for reasons other than fraud 3. Provider convicted of fraud 81 (Claim Too Old) 82 (Claim Is Post-Dated) 83 (Duplicate Paid/Captured Claim) 85 (Claim Not Processed) 88 (DUR Reject Error) AB (Date Written Is After Date Filled) AC (Product Not Covered Non-Participating Manufacturer) 1. Denied for ProDUR alert 1. Date prescribed is after the billing date 2. Dispense date on the claim is earlier than the date prescribed 1. NDC manufacturer not participating in the drug rebate program for date of service AI- 2 APPENDIX I NCPDP REJECT CODE AD (Billing Provider Not Eligible To Bill This Claim Type) AG (Days Supply Limitation For Product/Service) DU (M/I Gross Amount Due) DV (M/I Other Payer Amount Paid) E7 (M/I Quantity Dispensed) EC (M/I Compound Ingredient Component Count) M2 (Recipient locked in) M4 (Prescription/Service Reference Number/Time Limit Exceeded) M5 (Requires Manual Claim) M6 (Host Eligibility Error) M7 (Host Drug File Error) REASON CLAIM REJECTED 1. Billing provider ID number/claim type mismatch 1. Estimated days supply is greater than 31 2. Estimated days supply is either less than or greater than the days supply restriction established for the NDC being billed 1. Total billed amount is missing/invalid 1. Third party payment amount is invalid 1. Quantity dispensed is missing/invalid 2. Quantity billed is not consistent with package size 1. Compound claim has no details 1 Beneficiary is locked in to a specific pharmacy provider 2 Beneficiary is locked in to a specific prescribing provider 1. Schedule III & IV drugs cannot be filled/refilled for prescriptions over 6 months old 2. Schedule II drugs cannot be refilled if more than 60 days from the original dispense date 3. Maximum number of claim details exceeded 4. Drugs cannot be filled/refilled for prescriptions over 1 year old 1. Out-of-state mail order without other insurance payment 2. Provider is on review 3. Beneficiary is on review 4. Unable to determine beneficiary's Fund Code 5. NDC is on review 6. Claim is a suspect duplicate claim of a claim in process or a paid claim 7. NDC requires manual pricing 1. Unable to prioritize the beneficiary's benefit plan 1. NDC Strength Code not found (unable to determine dosage limit) AI- 3
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