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Quality Assurance

APPENDIX K

Achieving Better Care by Monitoring All Prescriptions

(ABC-MAP)

Requirements Document

Prepared by: Carol Runk

Project #: C0000007

Submitted to: Christine Filipovich,

Commonwealth of PA-Department of Health Quality Assurance

Project Sponsor

Date submitted 07/31/2015

Document version: V0.4

C0000007 (ABC-MAP) Page of Requirements Document


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Pages 5,9,15,17,22.1.0 Mm/dd/yy First Published

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Table of Contents

1 PURPOSE OF THE DOCUMENT..............................................................................42 ACRONYMS...............................................................................................................53 EXECUTIVE SUMMARY............................................................................................74 INTRODUCTION........................................................................................................9

4.1 PROJECT OVERVIEW..........................................................................................94.2 REFERENCES/INPUTS.......................................................................................10

5 BUSINESS MODEL.................................................................................................115.1.1 Organizational Profile...................................................................................125.1.2 High Level ‘As-Is’ Process Diagram.............................................................155.1.3 High Level ‘To-Be’ Process Diagram............................................................165.1.4 Process Mapping Diagram...........................................................................175.1.5 Gap Analysis................................................................................................18

6 REQUIREMENTS DEFINITION................................................................................196.1 OVERVIEW.......................................................................................................196.1.1 Approach......................................................................................................196.2 DETAILED REQUIREMENTS................................................................................19

7 ADDENDUM.............................................................................................................207.1 SAMPLE - UNIVERSAL CLAIM FORM (UCF)......................................................207.2 OAG - PENNSCRIPT DATA REQUEST FORM.....................................................21

8 GLOSSARY OF TERMS..........................................................................................229 SESSIONS SCHEDULE AND ATTENDANCE........................................................25



1 Purpose of the DocumentThe purpose of the Requirements Document (RD) is to lay the foundation for the design and development of a technical solution. The RD describes the high-level business process and also outlines the business needs that will be fulfilled by the successful completion of the project and also takes this one step further and identifies actual technical or system requirements for the solution.

The foundation for a successful project is built upon the quality and thoroughness of requirements gathering. The RD establishes key requirements, objectives, and goals that drive all other subsequent lifecycle phases. It describes the business problem to be solved in terms of verifiable and traceable characteristics and constraints. In addition to key program level requirements, the RD also captures operational concepts and program level interfaces. This document should be continuously referenced during the project lifecycle phases to ensure that the deliverables from the project meet the approved requirements.



2 Acronyms

Table: Acronyms Used in This Document

Acronym DefinitionABC-MAP Achieving Better Care By Monitoring All PrescriptionsASAP American Society for Automation in PharmacyBIIT Bureau of Informatics and Information TechnologyBJA Bureau of Justice AssistanceCHIP Children’s Health Insurance ProgramCMS Centers for Medicare and Medicaid ServicesCOTS Commercial-Off-The-ShelfDEA Drug Enforcement AgencyDHS Department of Human ServicesDOB Date of BirthDOH Department of HealthDOS Department of StateEHR' Electronic Health RecordFTP File Transfer ProtocolHIE Health Information ExchangeHIPAA Health Insurance Portability and Accountability ActMA Medical AssistanceNCPDP National Council for Prescription Drug ProgramsNDC National Drug CodeNPI National Provider IndexNPLEx National Precursor Log ExchangeOAG Office of Attorney GeneralOMAP Office of Medical Assistance ProgramsONC Office of the National CoordinatorOTC Over-the-CounterPACE Pharmaceutical Assistance Contract for the ElderlyPACENET Pharmaceutical Assistance Contract for the Elderly

Needs Enhancement TierPDA Pennsylvania Department of Aging

PDMP Prescription Drug Monitoring Program (used interchangeably with the term PMP).

PHI Protected Health InformationPID Pennsylvania Insurance DepartmentPII Personally Identifiable Information



PMIX Prescription Monitoring Information ExchangePMP Prescription Monitoring ProgramPMPi PMPInterConnect is a nation hub solution which

facilitates interstate data sharing and PDMP data intergration with healthcare system.

PSE PseudoephedrineSaaS Software-as-a-ServiceSAMHSA Substance Abuse and Mental Health Services

Administration



3 Executive Summary

Pennsylvania Department of Health (DOH) is responsible for delivering an expanded prescription drug monitoring program entitled “ Achieving Better Care By Monitoring All Prescriptions” (ABC-MAP). The foundation of the program is supported by the establishment of the ABC-MAP Board, Advisory Group, and a Program Office to manage the execution and direct the development of the program. This project includes the aquisition of a new enterprise Software-as-a-Service (SaaS) solution that will be the keystone for delivering state of the art PDMP technology to Pennsylvania and supporting the programs purpose to:

Increase the quality of patient care by giving prescribers and dispensers access to a patient's prescription medication history through an electronic system.

Alert medical professionals to potential dangers for purposes of making treatment determinations.

Provide patients with a thorough and easily obtainable record of their prescription history for purposes of making educated and thoughtful health care decisions.

Aid regulatory and law enforcement agencies in the detection and prevention of fraud, drug abuse and the criminal diversion of controlled substances.

During the requirements phase of this effort, review sessions were conducted with identified subject matter experts from the DOH, Department of Human Services (DHS), the Pennsylvania Insurance Department (PID), Department of State (DOS), Pennsylvania State Police (PSP), the Office of Attorney General (OAG), Department of Drug and Alcohol Programs (DDAP), and the Department of Aging (PDA) to gather information from the system stakeholders for the purpose of identifying necessary functional requirements and obtaining consensus on system features and functionality.

A gap analysis was performed on the As-Is and To-Be processes. They were analyzed and also used to create the business and system requirements presented later in this document. The most significant impacts to the business process were then identified and listed below:

1. The need to provide training and guidance to dispensers and prescribers on the use of the system and the information it will supply, to positively direct their interactions with the available information, and supporting effective delivery of appropriate and quality patient care.



2. Overall increase of data collection due to: a. Change from only monitoring Schedule II controlled substances, to

monitoring all Schedule II – V controlled substances. b. The inclusion of dispensing practitioners to the reporting population.

3. More frequent reporting timeframe. Changing from a monthly interval, to no later than 72 hours after a substance is dispensed.

4. Overall increase of system users. Exclusive use by the OAG will expand to 7 internal State organizations and to thousands of dispensers and prescribers externally across the state.

In conclusion, with greater capabilities and increased functionality of a new system, DOH is driven to meet its objectives.



4 Introduction

4.1 Project OverviewThe Pennsylvania Department of Health is responsible for implementing legislation passed that establishes the ABC-MAP Program. The ABC-MAP program is the prescription drug monitoring program for Pennsylvania. The ABC-MAP system will collect prescription data on all controlled substances (schedules II through V). This information will be available to authorized users to increase the quality of patient care by giving prescribers and dispensers access to patient’s prescription medication history through an electronic system that will alert medical professionals to potential dangers for purposes of making treatment determinations and aid regulatory and law enforcement agencies in the detection and prevention of fraud, drug abuse and the criminal diversion of controlled substances. Additionally, patients will be able to easily obtain a record of their prescriptions for making educated and thoughtful health care decisions.

The contractor must have an existing Prescription Drug Monitoring Program (PDMP) operating in other states. The contractor must be able to provide information and costs to substantiate their expertise in collecting and managing data, converting data from the existing PDMP, as well as training end users. The system must be capable of collecting prescription drug data from dispensers, housing the data in a secure site, establishing a secure web portal that can facilitate automated communication with authorized users, and providing secure online access for authorized users defined in Act 191 of 2014.

The system must be capable of supporting interstate data sharing, integrating with electronic health records (EHRs), health information exchange (HIE) and pharmacy dispensing systems to help facilitate prescriber and dispenser access to the data.

Dispensers will report the required dispensing information using the contractor’s PDMP. The contractor will collect, store, backup, and otherwise manage all data as well as all technical aspects of the PDMP. The contractor will provide registration and access necessary for prescribers, dispensers and assigned Commonwealth personnel.



4.2 References/InputsSources of information/reference materials that were used to develop the requirements, such as:

1. BJA, Justice System Use of Prescription Drug Monitoring Programs briefing: Addressing the Nation’s Prescription Drug and Opioid Abuse Epidemic; January 2015

2. Brandeis COE, Guidance on PDMP Best Practices - Options for Unsolicited Reporting; January 2014

3. Brandeis COE,An Assessment of the Evidence for Best Practices; September 2012

4. ONC / SAMHSA, A Roadmap For Connecting to Prescription Drug Programs Through Your Electronic Health Record; 2013

5. ONC / SAMHSA, Enhancing Access to Prescription Drug Monitoring Programs Using Health Information Technology: Work Group Recommendations, August 2012



5 Business Model

Pennsylvania’s Office of the Attorney General currently sponsors a SaaS Prescription Drug Monitoring Program (PDMP) database known as PENNscript. This function is administered by the Bureau of Narcotics Investigation (BNI), which has both criminal investigative authority and regulatory compliance authority with regard to controlled substances. The Office of Attorney General is authorized by law under Title 28 Pa Code, Chapter 25, Subchapter A, Section 25.131 to collect data regarding the dispensation of Schedule II controlled substances by pharmacies in Pennsylvania. Pharmacies are required to submit data on a monthly basis.

The OAG system monitors controlled substances designated by the Federal Drug Enforcement Agency (DEA) as Schedule II and over-the-counter (OTC) sales of pseudoephedrine (PSE); methamphetamine precursors. (As of April, 2014 in compliance with Pennsylvania House Bill 602, Act 35, pharmacies are now required to report PSE OTC sales to the National Precusor Log Exchange [NPLEx]).

Schedule II controlled substances have a high potential for abuse; therefore, the OAG manages the database primarily for purposes of law enforcement. BNI Agents and Analysts are authorized to query the system to asstist OAG investigations and on the behalf of Local, State, and Federal law enforcement in their efforts to address the misuse, abuse, and diversion of controlled substances.



5.1.1 Organizational Profile

This table provides a representation of the organizational titles and entities that are involved in, or will be affected by the implementation of the new system. This list should not be considered complete or final, but it will evolve with the devlopment of the ABC-MAP Program.

TITLE ORG DUTIESLegal Office Administrative Officer

DOSThe Bureau of Professional and Occupational Affairs provides administrative, logistical and legal support services to professional and occupational licensing boards and commissions.

DirectorDeputy DirectorHQ Administrative OfficerHQ CT3Regional DirectorProfessional Conduct Investigator

DOS The Bureau of Enforcement and Investigation provides the boards and commissions with facility inspection and law enforcement capabilities

Chief CounselExecutive Deputy Chief CounselDeputy Chief CounselProsecuting AttorneyParalegal

DOS Office of Chief Counsel

PhysiciansDentistsPharmacists

DHS Office of Medical Assistance Programs(OMAP) administers the joint state/federal Medical Assistance (MA) program (also known as Medicaid). The Bureau of Fee-For-Service Programs (BFFSP) provides: Medical review of services under Fee-For-Service including prior authorization, program exception, and benefit limit exception for pharmacy, dental/orthodontic, and medical services. Provide operational assistance to pharmacy providers, and inpatient/outpatient. Manages the pharmacy benefit through utilization management including the Preferred Drug List, prior authorization, drug use review,



TITLE ORG DUTIESand specialty pharmacy.

PhysiciansDentistsPharmacists

DHS OMAP - Bureau of Program Integrity (BPI) ensures Medical Assistance (MA) recipients receive quality medical services and that recipients do not abuse their use of medical services; applies administrative sanctions; refers cases of potential fraud to the appropriate enforcement agency. Bureau staff includes medical professionals responsible for preventing, detecting, deterring, and correcting fraud, abuse, and wasteful practices by providers of MA services.

ABC-MAP Program Office Staff DOH Quality AssuranceInvestigation AgentIntelligence Analyst

OAG Bureau of Narcotics Investigation (BNI) is the state agency legislatively mandated to enforce the provisions of Pennsylvania’s Controlled Substance, Drug, Device, and Cosmetic Act. Narcotics Agents assigned to BNI insures regulatory compliance with the act by engaging in inspections of those registered to manufacture, distribute, or dispense drugs regulated under the Act. In addition to being a law enforcement agency BNI is also defined as a healthcare oversight agency.

Utilization Review PDA Pharmaceutical Assistance Contract for the Elderly (PACE), PACENET and PACE plus Medicare are Pennsylvania's prescription assistance programs for older adults, offering low-cost prescription medication to qualified residents, age 65 and older.

Quality Assurance PID Children’s Health Insurance Program (CHIP) was created to address the growing problem of children without



TITLE ORG DUTIEShealth insurance. It was designed as a federal/state partnership, similar to Medicaid, with the goal of expanding health insurance to children aged 0 to 19 whose families earn too much money to be eligible forMedicaid, but not enough money to purchase private insurance.

MDAIR Team DDAP Methadone Deathand Incident Review Team (MDAIR) Reviews and examines the circumstances surrounding methadone-relateddeaths and methadone-related incidents in Pennsylvania for the purpose of promoting safety, reducing methadone-related deaths and incidents, and improvingtreatment practices. In addition to reviewing incident information statutorily required to be reported toDOH, the team works in collaboration with county coroners and medical examiners, as well as district attorneys, EMS providers and other parties, at developing a comprehensive reporting process that will gather additionalinformation for the team’s analysis.

DDS/DMD: DentistDO: Doctor of OsteopathyDP: Doctor of PodiatryMD: Medical DoctorND: NaturopathNP/CNS PP: NurseOD: Doctor of OptometryPA: Physician AssistantRPh: PharmacistMedical Examiner MDCounty Coroner

External Users (with designee’s)



5.1.2 High Level ‘As-Is’ Process Diagram

On a monthly basis pharmacies report dispensing information for Schedule II controlled substances to the PENNscript database. Approximately, 4300 Pennsylvania pharmacies, and 145 Out-Of-State pharmacies securely submit their data files electronically. Currently, there are 500 pharmacies manually submitting dispensing records via a universal claims form (UCF). BNI Agents and Analysts at the Office of Attorney General are the only authorized users permitted to directly query information in the PENNscript system. These users are also permitted to request information on the behalf of Local, State, and Federal law enforcement agencies. Law enforcement officials must submit a data request form to the OAG to obtain dispensing information on Schedule II controlled substances. A sample UCF and PENNscript Data Request form are illustrated in Sections 7.1 and 7.2 for the Addendum.

Figure 1



5.1.3 High Level ‘To-Be’ Process Diagram

Act 191 (2014) requires PA DOH to implement a new Prescription Drug Monitoring Program as an enterprise solution to address patient safety and the growing problem of prescription drug abuse. Additionally, Act 191 requires that the PENNscript program, managed by the OAG, be wholly merged into the ABC-MAP system. The system architecture is expected to support interstate data exchange and HIE for EHR intergration. System compacity throughput must support unlimited DOH and external users, such as: prescribers, dispensers, OAG personnel, designated licensing board representatives, approved personnel from the Department of Drug and Alcohol Programs, investigating medical examiners and county coroners, in addition to personnel for the Depatment of Aging, DHS, PA Insurance Department, and other selected designees having an approved need to access Pennsylvania’s PDMP information. Despenser will be required to submit dispensing information for Schedule II-V controlled substances no later than 72 hours after dispensing the substance. Patients will be allowed to request a report of their prescription history for purposes of making educated health care decisions.



Figure 2

5.1.4 Process Mapping Diagram

The process mapping diagram is a visual representation illustrating the functions that will be addressed by the proposed solution. The system will provide role based access to a number of internal and external users. The system will provide adequate security checks to ensure authorized access to confidential data. It will also include data validation and business rules to maintain data accuracy and integrity at all times. Incoming data will be verified by the system and the records that do not pass the rules, will need to be reviewed and corrected by the submitter.

The diagram also provides an overview of some of the inputs and outputs of the system. The new system will provide the capability to generate unsolicited and on-demand reports. Canned and ad-hoc reporting will be available for various levels of stakeholder groups to assist them in compliance reviews, decision making, trending, and quality assurance.



Figure 3

5.1.5 Gap Analysis

ABC-MAP expands prescription drug monitoring of DEA controlled substances to Schedules II-V and the Act places management of ABC-MAP within the Department of Health (DOH). Act 191 broadened the definition of a dispenser to include dispensing prescribers into the pool of members that are required to report disensing information to the PDMP. Additionally, requiring more frequent reporting timeframes. The new program will also significantly expands the purpose for collecting this type of data as well as the number and role types of authorized users of the data. This initiative shall result in a new enterprise-wide data management system for ABC-MAP and it will absorb all data currently maintained by OAG in the PENNscript database.



6 Requirements Definition

6.1 Overview

6.1.1 Approach

New legislative mandates imposed by Act 191 of 2014; establishing the Achieving Better Care By All Prescriptions (ABC-MAP) program. Best practices recognized by the industry Center of Excellence (COE), and the expertise of designated subject matter experts (SME) were resourced during requirements gathering from the Department of Aging , Department of Drug and Alcohol Programs, Department of Human Services, Department of Health, Department of State,Pennsylvania State Police, Insurance Department, and the Office of Attorney General. The session schedule including the list of attendance is referenced in Section 9, Session Schedule and Attendance; figure 4.

6.2 Detailed Requirements The project team used the DOH Project Management Office (PMO) Requirements Tool template to document the business requirements, system requirements, and traceability. Please note in the attached workbook there is a worksheet for each of these topics. The requirements category, sub-category, ID, priority, and source for each system requirement is indicated in the tool. Reference Appendix L, ABC-MAP Detailed Requirements Matrix.



7 Addendum

7.1 SAMPLE - Universal Claim form (UCF)


Figure 4


7.2 OAG - PENNscript Data Request Form

Figure 5



8 Glossary of Terms

<Include all terms that may not be familiar to the reader.>

Table: Glossary of Terms used in This DocumentTerm Definition

Ad Hoc Query A query created for the purpose to obtain information as the need arises.

Addiction Specialist A physician licensed by the State Board of Medicine and certified by the American Board of Addiction Medicine.

Authentication The process of verifying the identity and credentials of a person before authorizing system access.

Board The ABC-MAP Board established in section 4 of Act No. 191, P.L. 2911, Oct. 27, 2014.

Controlled substance A drug, substance or immediate precursor included in the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, or the Controlled Substances Act (Public Law 91-513, 84 Stat. 1236).

Department The Department of Health of the Commonwealth.Dispense To deliver a controlled substance, other drug or device

to a patient by or pursuant to the lawful order of a prescriber.

Dispenser A person lawfully authorized to dispense in this Commonwealth, including mail order and Internet sales of pharmaceuticals.The term does not include any of the following: (1) A licensed health care facility that distributes the controlled substance for the purpose of administration in the licensed health care facility. (2) A correctional facility or its contractors if the confined person cannot lawfully visit a prescriber outside the correctional facility without being escorted by a corrections officer. (3) An authorized person who administers a controlled substance, other drug or device. (4) A wholesale distributor of a controlled substance. (5) A licensed provider in the LIFE program. (6) A provider of hospice as defined in the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act. (7) A prescriber at a licensed health care facility if the quantity of controlled substances dispensed is limited to



Term Definitionan amount adequate to treat the patient for a maximum of five days and does not allow for a refill. (8) A veterinarian. (1) A licensed health care facility that distributes the controlled substance for the purpose of administration in the licensed health care facility. (2) A correctional facility or its contractors if the confined person cannot lawfully visit a prescriber outside the correctional facility without being escorted by a corrections officer. (3) An authorized person who administers a controlled substance, other drug or device. (4) A wholesale distributor of a controlled substance. (5) A licensed provider in the LIFE program. (6) A provider of hospice as defined in the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act. (7) A prescriber at a licensed health care facility if the quantity of controlled substances dispensed is limited to an amount adequate to treat the patient for a maximum of five days and does not allow for a refill. (8) A veterinarian.

Licensed Health Care Facility

A health care facility that is licensed under Article X of the act of June 13, 1967 (P.L.31, No.21), known as the Public Welfare Code, or the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act.

LIFE program The program of medical and supportive services known as Living Independently For Elders

Pharmacy As defined in the act of September 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act.

Prescriber A person who is licensed, registered or otherwise lawfully authorized to distribute, dispense or administer a controlled substance, other drug or device in the



Term Definitioncourse of professional practice or research in this Commonwealth. The term does not include a veterinarian.

Program The Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) established in section 6 of Act No. 191, P.L. 2911, Oct. 27, 2014.

Solicited Reporting Data is provided to authorized users based upon their request for the information. (Also known as reactive reporting)

System The program's electronic prescription monitoring system with a database component.

Unsolicited Reporting Information is analyzed and reported to appropriate personnel based identified critera and thresholds established by the program. (Also known as proactive reporting)

Zero Report A report submitted to the system which indicates a facility did not dispense any prescriptions during a defined period.



9 Sessions Schedule and Attendance


AGENCY DEPARTMENT CONTACT FIRST NAME

LAST NAME

TITLE E-Mail

Pennsylvania State PoliceMonday; 7/6/2015 10AM

Bureau of Criminal Investigation

Karina Betz Intelligence Analyst Supervisor

[email protected]

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