EXHIBIT__L-14_DRAFT_TPharm4_ProDUR_Parameters_(Aug_30_2013).doc

DRAFT DoD Pharmacy Prospective Drug Utilization Review Parameters Effective as of August 30, 2013

** Note: This document is not all-inclusive and only describes those ProDUR requirements that may differ from standard commercial practices. **

1. Prospective Drug Utilization Review

The ProDUR process reviews the submitted dispensing with respect to patient attributes (e.g., age, gender) and with respect to other active medications on the patient’s profile. ProDUR includes the functionality identified below.

2. Highly Flexible Designation of Drugs ProDUR edits require the designation of drugs subject to the edit. The collection of drugs subject to a particular edit is the Drug Set for that edit. DoD pharmacy supports the designation of a different Drug Set for each edit it performs This allows flexibility in granularity, extensibility, and exception support when defining a Drug Set.

· Granularity DoD pharmacy supports the identification of drugs for edit purposes, including but not limited to, at the levels listed in the table below. Many of these levels correspond to proprietary data fields established and maintained by First DataBank (FDB).

Group Description (FDB Field)

DEA Schedule Code (Schedule 2,3,4,5)

Drug Category Code

Drug Class Code (Legend, OTC)

Route of Administration

GCx (GC1, GC2, GC3, & GC4)

Generic Code Number (GCN)

GCN Sequence Number (GCN_SEQ)

Therapeutic Class, Standard

Therapeutic Class, Generic

Therapeutic Class, Specific (GC3)

Therapeutic Class, AHFS

Package Description (PD)

Dosage Form Code

Formulary List

National Drug Code (NDC)

· Extensibility

DoD pharmacy allows the designation of multiple levels of granularity and multiple values for each level of granularity when designating the drugs subject to an edit. Thus, the designation of a Drug Set for a particular purpose could include five (5) NDCs, one (1) package description and three (3) GCNs.

· Exception Support

DoD pharmacy allows designation at a more granular level to override designation at a less granular level. Thus, if a drug set is identified at the GCN_SEQ level as subject to an edit, DoD pharmacy supports the ability to exempt particular NDCs from the edit.

3. Point of Service Specificity

· Specific edits can be bypassed or altered depending on Point-of Service. (MTF, TPharm Retail, TPharm Mail Order, Theater, CHDR) These points-of-service are identified by their assigned Processer Control Number (PCN).

· Violation of a ProDUR edit may result in a rejection or warning to a TPharm and MTF pharmacy.

· Within DoD Pharmacy, CHCS performs ProDUR for sites within the same host, while the claims adjudicator performs ProDURs between MTF pharmacies on different hosts or between the retail and mail points of service.

4. MTF Edit Implementation Methodology

· MTF hosts implement a new release of CHCS/AHLTA software by installing it in one host, then establishing a window of from a few weeks to months for the remainder of the MTFs to implement the new software.

· New or different responses are returned to MTF hosts as edits are activated in synch with the rollout of CHCS/AHLTA software across the MTF host population.

· Issues may occur as a result of changes in CHCS/AHLTA implemented by a specific host that impact adjudication. The claims adjudicator troubleshoots and resolves these issues directly with the MTF.

· The above will also apply to any successor application to CHCS/AHLTA, including any integrated pharmacy software.

5. ProDUR Edits - Summary Drug/Patient Profile ProDUR Edits – DoD pharmacy supports:

· Gender-based Edits

· Age-based Edits Drug/Medication Profile DUR Edits

· The “ProDUR Medication Profile Look-back Period” is the date range that determines which dispensings are considered when conducting drug-to-Medication Profile ProDUR. DoD pharmacy may establish a different look-back period for each of the following ProDUR checks for each Point of Service (MTF, TPharm Retail, TPharm Mail Order, Theater, CHDR):

· Drug/Drug (DD) Interaction

· Therapeutic Duplication (TD)

· Ingredient Duplication (ID)

· Over-Utilization (ER)

· Under-Utilization (LR)

· Step Therapy (SR)Excessive Dose (HD)

· Insufficient Dose (LD)

· Maximum Days Supply (EX)

· Duration of Therapy (MX)

· DoD pharmacy supports Therapy Duplication and Drug-to-Drug Interaction in accordance with the rules below regardless of the PCN value (i.e., Point-of-Service) submitted on the transaction except between MTF pharmacies on the same CHCS host.

6. DRUG-TO-DRUG INTERACTION (DD)

· Response to Submitter Severity Levels used by DoD pharmacy corresponds to the most current release of First DataBank’s DDIM.

· Level 1: Contra-Indicated: Reject

· Level 2: Severe / Potentially Manageable: Advisory

· Level 3: Moderate: Advisory

· Level 9: Currently Disabled - Unspecified but potentially severe interaction with alternative medication (e.g., herbal, nutraceutical)

· Lookback Period: Configurable; up to 365 days

· Bypasses

· Bypass rules may be configured by point-of-service (Mail, Retail, MTF)

· Bypass if the interacting products were dispensed by the same Retail pharmacy

· Other bypass configurations are possible

· Response Message: Type A Text Message that includes label name and NDC of interacting drug.

7. THERAPEUTIC DUPLICATION (TD) / INGREDIENT DUPLICATION (ID)

· This functionality is configurable by and within the Point of Service (MTF, TPharm Retail, TPharm Mail Order, Theater, CHDR).

· The intent of Duplication edits is to achieve a satisfactory balance between these goals:

· Allow the patient to receive a subsequent filling in time to assure that therapy is not interrupted

· Restrict the patient from obtaining and accumulating drug too far in advance of when it is needed

· These two goals are achieved by establishing a business rule that:

· Guarantees a subsequent dispensing can occur an absolute minimum number of days in advance of the Date Exhausted (Original Date-of-Service + Days Supply)

· Requires a specific percentage of the prior dispensing be consumed prior to allowing a subsequent dispensing

· Because there are two components to the business rule, there are two factors needed to determine the earliest date on which a subsequent dispensing may occur:

· Minimum Days Overlap

· % of Original Days Supply Exhausted

· Each factor is used to determine a date; the earlier (lesser) of the two dates becomes the first date that a subsequent dispensing may occur.

· Minimum Days Overlap Date = Greater of (Original Fill Date, Date Exhausted – Minimum Days Overlap) where Date Exhausted (Original Date-of-Service + Days Supply)

· Note : The Greater Of comparison insures that the resulting date will not fall BEFORE the Original Fill Date.

· % of Original Days Supply Exhausted Date = Original Fill Date + (% Days Supply Exhausted * Days Supply)

· Earliest Subsequent Fill Date = Lesser of (Minimum Days Overlap Date, % of Original Days Supply Exhausted Date)

· In addition to the calculations, DoD pharmacy allows for customization in the drug component that allows the edits to stay within a specific therapeutic class, clinical entity, broad drug category or cross over to other specific therapeutic class, chemical entity or broad drug class. Customization can vary by drug form/route/strength for a specified drug.

· Tolerance/TD (configurable)

· Retail: 75% of days supply or 10 days (as explained above) (configurable)

· Mail Order: 75% of days supply or 10 days (as explained above)

· Tolerance/ID (configurable)

· Retail: 75% of days supply or 10 days (as explained above) (configurable)

· Mail Order: 66% of days supply or 10 days (as explained above)

· The TD edit allows for a combination of FDB GC3’s to produce a TD reject. The DoD currently uses FDB GC3’s to define these combinations but PDTS is required to define these combinations using any level of FDB drugs classifications.

· Therapy Duplication at the GCN Level GCN Override: Therapy Duplications detected at the GCN level will return ProDUR conflict code of “ID” (Ingredient Duplication) with the date of next fill and number of days from dispense date to next fill within the message. Where same GCN override occurs, the text message contains the date that refill is allowed and the number of days between the dispense date submitted and the dispense date allowed. Example: “Next Fill 01/01/2001 Days=001”.

· Therapy Duplication at the Therapeutic Class (GC3) Level – For selected Therapeutic Classes, this edit will be performed at the Therapeutic Class level (GC3).

· Overlaps within a Single Therapeutic Classes will trigger a desired therapy response.

· Exceptions to the Therapy Duplication / Ingredient Duplication edits:

· The route of administration is considered, for both Therapeutic Class (GC3) and Ingredient level (HICL), and only overlapping ingredients in systemic routes of administration will be edited. Non-Systemic routes of administration products bypass therapy duplication edits (e.g. Topical, Ophthalmic, Otic, Intradermal, Dental). Example:

· Erythromycin cream and erythromycin ophthalmic ointments are not in a targeted therapeutic class. They will be edited at the HICL level. They are both non-systemic routes of administration, so they will bypass the edit.

· Medical Supplies (94200) bypass the Ingredient Duplication edits.

8. EXCESSIVE DOSE (HD)

· Response to Submitter: Reject

· Tolerance: Configurable; currently 100% above the FDB-supplied Maximum Dose

9. INSUFFICENT DOSE (LD)

· Response to submitter: advisory

10. OVER UTILIZATION (ER)

· Response to Submitter: Reject

· Lookback Period: Configurable; up to 365 days

· Tolerance: Configurable by Route of Administration; currently 100% above the FDB-supplied Maximum Dose

· Bypasses: Bypass ER edit for the following routes of administration; topical, ophthalmic, otic, intradermal, dental

· DoD Pharmacy applies dosage ranges that correspond to the determined patient classification (Pediatric, Adult, Geriatric).

· Patient weight is required to perform pediatric edits. Because patient weight is not available in the system, the First Data Bank national age/weight tables are used to estimate patient weight based on the birth date and gender submitted on the transaction.

11. UNDER UTILIZATION (LR)

· Lookback Period: Configurable; up to 365 days

· Tolerance: Configurable; currently 50% below the FDB-supplied Minimum Dose

· Bypasses Bypass LR Edit for all drugs EXCEPT Maintenance Drugs

· Drug Level: GCN

12. MAXIMUM DAYS SUPPLY (EX)

· Response to Submitter:

· If Days Supply exceeds Maximum: DUR Advisory

· If Days Supply exceeds Absolute Maximum: Reject

· Lookback Period: None; this edit applies to the current claim only

· Current Configuration

· MTF: Maximum = 200 days; Absolute Max = 400 days

· All Other Points of Service: Not Set

13. DURATION OF THERAPY (MX)

· DoD pharmacy utilizes this functionality.

14. PREGNANCY

· DoD pharmacy may utilize this functionality at a future date.

15. AUTOMATED PROFILE REVIEW (APR)

· DoD pharmacy utilizes an automated profile review, which is used in Step Therapy or ProDUR situation for safety edits. This provides the capability to automate a profile review of for pharmaceuticals or drug classes prior to the dispensing of the current drug product.

· The APR edit can be refined with additional modifiers:

· Profile look back period (at a minimum of 180 days up to 360 days)

· Brand/generic requirements

· Effective and expiration dates

· Pharmacy Type (Retail, Mail, or MTF)

· Beneficiary Age and Gender

· Exclusions for DMR, COB, and MPD claims

· Ability to auto-create a PA record

· Ability to flag medical necessity on active duty beneficiaries

· Specialized messaging returned to the pharmacy if the transaction fails (minimum of 250 characters)

· For a transaction that fails the automated profile review edit, the response can be varied for each edit such as Drug Not Covered (Reject Code 70), Prior Authorization Required (Reject Code 75), DUR conflict (Reject Code 88, DUR Code “SR”)

16. Miscellaneous Edits

· Date-Related Edits

· DoD pharmacy allows future dates of service for MTF claims. MTF providers may order prescriptions in advance of dispensing. All edits are performed in a clinically correct fashion based on the date of the eventual dispensing. Current dispensings anticipate clinical conflicts that will occur upon the eventual dispensing of these drugs.

· The International Date Line is recognized when performing date of service “post dated” edits.

· Profile Maximum Accumulated Dispensing

· DoD pharmacy sets limits on a drug by drug benefit that vary in quantity limits over varying periods of time for the various points of service. As with other aspects of the DoD benefit design, the limits can be specific within a therapeutic class or span multiple drug categories, chemical entities or therapeutic classes.

· DoD pharmacy administers factored profile maximum quantity limits (accumulative dispensing limits that vary based on the dispensing location) as listed in the DoD Formulary Restrictions and Limitations.

17. Non-Standard Transactions

· Profile Inquiry Transaction DoD pharmacy allows for DoD direct care providers and managed care support contractors to submit real-time transactions requesting a patient medication profile. Upon receipt of a query transaction, the profile of the designated patient is searched for all prescriptions whose most current dispensing falls within the look-back range specified on the query. Those dispensing are returned in the response. Included in the response is the original fill date.

· For example, using information such as the date filled and level of service, a query submitted on 4-1-2011 with a look-back range of 30 days:

· Calculated Date Range = 3/1/2011 (4/1/2011 - 30) thru 4/1/2011

· An Rx is filled on 3-1, 3-11, and 3-21: the 3-21 dispensing is returned and includes the original 3-1 fill date as a data element

· An Rx is filled on 2-15 and 3-15: the 3-15 dispensing is returned and includes the original 2-15 fill date as a data element

· An Rx is filled on 1-15 and 2-15: it is not returned because the most recent dispensing falls outside the look-back range

· Prescriptions are returned in Last-in-First-Out (LIFO) order – the most current dispensing is returned first.

· The maximum number of prescriptions that can be returned pursuant to a query is 20. If there are additional prescriptions that satisfy the look-back range, an Overflow indicator is returned. A subsequent query may be submitted to obtain additional prescriptions beyond the first 20.

· Prescriptions dispensed by the querying pharmacy host are not returned in the profile inquiry. (MTF pharmacies are grouped by MTF host and share the same host CHCS system.) The basis for this rule is that the host already knows about the prescriptions it has dispensed.

· Query 2 is submitted with a Date Filled = current date + 28 days (for example) and a Level of Service= 11 (30 days)

· Only those prescriptions whose most recent dispensing is GTEQ Current date – 2 days are returned.