APPENDIX K
Achieving Better Care
by Monitoring All Prescriptions
(ABC-MAP)
Requirements Document
Prepared by: / Carol RunkProject #: / C0000007
Submitted to: / Christine Filipovich, Project Sponsor
Date submitted / 07/31/2015
Document version: / V0.4
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Version / Date / Author / Status / Revision Descriptions0.2 / 07/10/2015 / Carol Runk / Initial Draft
0.3 / 07/31/2015 / Carol Runk / Initial Draft / Preliminary Revisions
0.4 / 08/04/2015 / Carol Runk / Initial Draft / Additional Revisions: 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 4
2 Acronyms 5
3 Executive Summary 7
4 Introduction 9
4.1 Project Overview 9
4.2 References/Inputs 10
5 Business Model 11
5.1.1 Organizational Profile 12
5.1.2 High Level ‘As-Is’ Process Diagram 15
5.1.3 High Level ‘To-Be’ Process Diagram 16
5.1.4 Process Mapping Diagram 17
5.1.5 Gap Analysis 18
6 Requirements Definition 19
6.1 Overview 19
6.1.1 Approach 19
6.2 Detailed Requirements 19
7 Addendum 20
7.1 SAMPLE - Universal Claim form (UCF) 20
7.2 OAG - PENNscript Data Request Form 21
8 Glossary of Terms 22
9 Sessions Schedule and Attendance 25
C0000007 (ABC-MAP) / Page 20 of 26 / Requirements DocumentCommonwealth of PA-Department of Health / Quality Assurance
1 Purpose of the Document
The 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 Prescriptions
ASAP / American Society for Automation in Pharmacy
BIIT / Bureau of Informatics and Information Technology
BJA / Bureau of Justice Assistance
CHIP / Children’s Health Insurance Program
CMS / Centers for Medicare and Medicaid Services
COTS / Commercial-Off-The-Shelf
DEA / Drug Enforcement Agency
DHS / Department of Human Services
DOB / Date of Birth
DOH / Department of Health
DOS / Department of State
EHR' / Electronic Health Record
FTP / File Transfer Protocol
HIE / Health Information Exchange
HIPAA / Health Insurance Portability and Accountability Act
MA / Medical Assistance
NCPDP / National Council for Prescription Drug Programs
NDC / National Drug Code
NPI / National Provider Index
NPLEx / National Precursor Log Exchange
OAG / Office of Attorney General
OMAP / Office of Medical Assistance Programs
ONC / Office of the National Coordinator
OTC / Over-the-Counter
PACE / Pharmaceutical Assistance Contract for the Elderly
PACENET / Pharmaceutical Assistance Contract for the Elderly Needs Enhancement Tier
PDA / Pennsylvania Department of Aging
PDMP / Prescription Drug Monitoring Program (used interchangeably with the term PMP).
PHI / Protected Health Information
PID / Pennsylvania Insurance Department
PII / Personally Identifiable Information
PMIX / Prescription Monitoring Information Exchange
PMP / Prescription Monitoring Program
PMPi / PMPInterConnect is a nation hub solution which facilitates interstate data sharing and PDMP data intergration with healthcare system.
PSE / Pseudoephedrine
SaaS / Software-as-a-Service
SAMHSA / 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 Overview
The 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/Inputs
Sources 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 / DUTIES /Legal Office Administrative Officer / DOS / The Bureau of Professional and Occupational Affairs provides administrative, logistical and legal support services to professional and occupational licensing boards and commissions.
Director
Deputy Director
HQ Administrative Officer
HQ CT3
Regional Director
Professional Conduct Investigator / DOS / The Bureau of Enforcement and Investigation provides the boards and commissions with facility inspection and law enforcement capabilities
Chief Counsel
Executive Deputy Chief Counsel
Deputy Chief Counsel
Prosecuting Attorney
Paralegal / DOS / Office of Chief Counsel
Physicians
Dentists
Pharmacists / 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, and specialty pharmacy.
Physicians
Dentists
Pharmacists / 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 Assurance
Investigation Agent
Intelligence 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
health 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 Death
and Incident Review Team (MDAIR) Reviews and examines the circumstances surrounding methadone-related
deaths and methadone-related incidents in Pennsylvania for the purpose of promoting safety, reducing methadone-related deaths and incidents, and improving
treatment practices. In addition to reviewing incident information statutorily required to be reported to
DOH, 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 additional
information for the team’s analysis.
DDS/DMD: Dentist
DO: Doctor of Osteopathy
DP: Doctor of Podiatry
MD: Medical Doctor
ND: Naturopath
NP/CNS PP: Nurse
OD: Doctor of Optometry
PA: Physician Assistant
RPh: Pharmacist
Medical Examiner MD
County 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.