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1 Team 7 Project E-Prescribing Team 7 Final Project E-Prescribing Segun Dawodu Jim Grubel Chris Beuning Northwestern University HIT Integration, Interoperability & Standards – MMI 405 Guilherme Del Fiol, M.D., Ph.D. March 4, 2012 2 Team 7 Project E-Prescribing System Description and Anticipated Benefits: The Centers for Medicare and Medicaid Services (CMS) defines electronic prescribing or e-prescribing as “a prescriber’s ability to send an accurate, error-free and understandable prescription directly to a pharmacy from the point of care.” Traditional written prescriptions and their interpretation and filling are prone to various errors during these processes. Transmission of prescription information electronically can significantly mitigate the risk of these errors, with the assumption that there is consistency in data interpretation or that semantic interoperability exists. The data transmitted with e-prescribing involves a number of complex data types, such as dates, allergies, medications, instructions for use, refill information, provider information, patient information and a variety of benefit information. “Semantic interoperability requires that the meaning of data be unambiguously exchanged from machine to machine.” (Mead, 2006, p. 73) Success of e-prescribing depends heavily on semantic interoperability There are many components of medication prescribing that are prone to errors, including sound alike medications, problematic abbreviations and indecipherable handwriting. Many medications have very similar sounding or looking names. The Institute for Safe Medication Practices (ISMP) has an eight-page list of commonly mixed up medication pairs and many medical safety advocates have lists of abbreviations that should not be used. Despite these resources and recommendations, errors continue to occur. There are also a multitude of reports of errors related to poor handwriting. These and other risks can be mitigated by using e-prescribing technology. Additional benefits to e-prescribing include the streamlining of refill requests and authorization. Using eprescribing technology pharmacies can send electronic requests for refill authorization to providers who can in turn send approval electronically.. This reduces the usual phone call, faxing and messaging systems that have risks for failure, omission and duplication of efforts. Electronic transmission of prescriptions is part of both Meaningful Use State 1 and 2. For the proposed Stage 2 criteria the expectation is that 65 percent of permissible prescriptions are transmitted electronically through certified EHR technology. Meeting this criteria can be important to the financial viability of providers and organizations. The success of this technology depends on sending and receiving systems applying the same definition to key terms including medication names, medication use directions, allergy information and diagnoses. E-prescribing functionality can transmit additional patient data such as allergy and diagnosis information as well as insurance information and medication use or prescribing history. Standard terminology and discrete data elements in the prescription are critical to the success of this functionality. Stakeholders: The stakeholders listed below are affected by e-prescribing. Stakeholder Group Needs/Role ● ● ● ● ● ● Representatives Physician Assistants Nurse Practitioners Clerical Staff Patients Community Pharmacies ● Initiating the electronic prescription process. ● ● ● ● ● Pharmacy Benefit Management (PBMs) Vendor Need medication(s) contained in prescription Must be able to receive prescriptions electronically. Needs to receive prescriptions electronically ● Technical Support ● ● ● ● Training ● Supplying application capable of transmitting/receiving prescriptions. Maintain equipment, provide application upgrades, etc. Need for communication, job aides, etc. 3 Team 7 Project E-Prescribing Information Flow and Data Architecture: E-prescribing involves the transfer of prescription data, including new prescriptions, prescription changes, refill requests, prescription fill status notification, prescription cancellation, medication history and transactions for long term care environments. Newer additions include Drug Use/Utilization Review (DUR) alerts, standardized instructions, allergies, structured diagnosis information, clinical exchanges and the use of RxNorm for standardized medication nomenclature. This information is sent between pharmacies, prescribers, intermediaries and payers. The standard used to communicate this information is NCPDP SCRIPT Standard. This standard was first published in 1997 and is updated annually. The Centers for Medicare and Medicaid Services (CMS) adopted these standards in 2006. "The current process today begins with a physician generating a handwritten prescription that the patient delivers to the pharmacy. The pharmacy interprets the handwritten information and enters the data into a computer system that connects with the pharmacy benefit management (PBM) program that is used by the patient's insurer. The PBM checks the prescription (electronically) for it's compliance to a pharmacy program, possible drug interactions based on the patient's mediation history, and any other utilization criteria. If there is an issue on any element, a message is sent back to the pharmacist, who then may need to intervene. Many times this requires a call to the physician to change the prescription to another medication." (Slideshare.net 2012). Implementation of eprescribing systems can largely replace the manual and error prone parts of this process. The diagram below illustrates the multiple senders, receivers and directions the data takes during the eprescribing process. Participating providers can provide patient history and formulary information to the eprescribing vendor prior to the patient’s visit based on the provider’s schedule in advance.. This can assist with verification of eligibility, formulary and drug history during the patient visit (item 4 on the diagram). Item 2 on the diagram illustrates the information that is transferred between the e-prescribing vendor and the Pharmacy Benefit Manager (PBM) including patient name, date of birth, member ID and member plan information. Based on the information provided to the PBM it is able to verify patient eligibility, formulary and medication history (item 3). This information in turn can be used by the provider during the patient visit. This allows the provider to write prescriptions during the visit with real time access to the vendor data. As the provider writes the prescription it is transmitted electronically or via fax to the patient's pharmacy (item 5). The final pathway (item 6) is the prescription data transmitted to the PBM with claims information for payment (Slideshare.net, 2012). 4 Team 7 Project E-Prescribing Data to be exchanged and standards to be used: The following standards are based on industry consensus and recommendations from the National Committee on Vital and Health Statistics (NCVHS) and will also form the basis for any modifications for future standards and interoperability. The design criteria for e-prescription drug program standards require:● No undue administrative burden on prescribing healthcare professionals and dispensing pharmacists and pharmacies. ● Be compatible with general health information technology standards and the standards established under relevant laws, and ● Permits the electronic exchange of drug labeling and drug listing information maintained by the Food and Drug Administration (FDA) and National Library of Medicine (NLM). The standards discussed below must be complied with when prescribers and dispensers transmit directly or through an intermediary, prescriptions and prescription- related information using electronic media with the following exceptions:● When information is being transmitted by means of a computer-generated facsimile, the National Council for Prescription Drug Programs (NCPDP) SCRIPT standards need not be used. ● Transmission of information within the same entity may use either HL7 messages or the NCPDP SCRIPT standard internally but externally with another an entity, the NCPDP SCRIPT standard must be used. ● Where a prescriber by law is mandated to issue a prescription to a non-prescriber e.g. a nursing home that in turn forwards the prescription to a dispenser, the requirement to use the NCPDP SCRIPT is exempted. MESSAGING AND ADT Team 7 Project E-Prescribing 5 To enable data to be exchanged using the standards enumerated below, the Health level 7 (HL7) messaging standard will be adopted. This will enable the E-prescribing to retrieve data from the Admission, Discharge and Transfer (ADT) system that are required in the process of prescribing medications and to exchange information with other components of the ADT such as the Administrative System, Computer Physician Order Entry (CPOE) and the Electronic Medical Records (EMR). Some of the data inherent within the other members of the ADT as mentioned may therefore be needed to be assessed and transmitted as part of the exchanges involving the e-prescribing within the ADT. The HL7 messaging allows the requisite e-prescribing to be exchanged with the ADT through the three different types which are unsolicited update, query and error. Such messaging in the process of using the HL7 standards will contain the information about the patient that may include the demographics, diagnosis, procedures, other laboratory information, other medications, etc. The use of NCPDP SCRIPT standard in message transmission is also described below. NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS SCRIPT E-Prescribing uses the NCPDP Script standard. The National Council for Prescription Drug Programs (NCPDP) creates and promotes data interchange standard for the pharmacy services sector of the health care industry. The NCPDP is an ANSI-accredited organization (NCPDP.org, 2012). The membership consists of three categories. There is the Producer/Provider category includes retail pharmacies, pharmaceutical manufacturers, and long term providers. The Payer/Processor category includes Pharmacy Benefit Management Companies (PBM), Health Insurers, State and Federal Agencies and Health Maintenance Organizations (HMO). These standards address data related to prescription down to dispense quantity and directions. Use of these standards and e-prescribing are dependent upon having prescriptions available as discrete data elements, typically generated by an Electronic Health Record (EHR) or other electronic system. “Within SCRIPT, basic business operations such as the communication of prescription information between prescriber and pharmacy and medication history information between entities can all be handled electronically” (http://NCPDP.com, 2012). The NCPDP SCRIPT standard use in prescription is to get message transaction, status response transaction, error response transaction, new prescription transaction, prescription change request transaction, prescription change response transaction, refill prescription request transaction, refill prescription response transaction, verification transaction, password change transaction, cancel prescription request transaction and cancel prescription response transaction. NATIONAL PROVIDER IDENTIFIER The National Provider Identifier (NPI) is a number assigned and unique to each provider entity including individuals and institutions. It is a standard that is used in identifying health care providers in e-prescribing transactions. The NPI is mandatory for all health care providers in the US and its use in e-prescribing will allow the identification of the prescribing entity and the dispensing entity. Transmission of e-prescribing data including the NPI will therefore allow exchange of the information between the entities involved. DISEASE CLASSIFICATION Within the use of e-prescribing, the requirement of the need to match the patient’s diagnoses with the medications and other information within the ADT is essential for many reasons including the need to ensure that the medication being prescribed falls within a diagnosis that is being treated, to also ensure that any other medication that the patient may be taking for such other medical conditions that may conflict with each other and any possible contraindication for such medication use in a patient with such a condition. An example will be the prescription of plavix in a patient with thrombocytopenia who may be in danger of having his platelets decreased to a serious level that could increase propensity to bleeding. This may need to be used within the ADT and thereby allowing checks on diseases through query that may make the use of specific medications contraindicated. The recommended standard terminology in this instance to define medical diagnosis will be the International Classification of Diseases, 10th edition (ICD-10-CM) which has been in existence since 1992. Currently, the 9th edition – ICD-9 which was created in 1977 is being used with plan in the US for mandatory change to the ICD-10 by October 2013 (although a statement by the DHHS on February 15, 2012 said this date may be deferred). The ICD-10 has the advantage of having up to 7 digits to create a higher ramification of diseases. In addition it has an exclusion component that prevents some codes to be used simultaneously with it. This terminology will enable an improved and more precise identification of a disease within its hierarchical classification, making it easier to be identified. The ICD-10 is also mapped/coordinated with the Diagnostic and Team 7 Project E-Prescribing 6 statistical manual of mental disorders (DSM) allow psychiatric terms to be ingrained with it. With the e-prescribing, the ICD codes will allow the patient diagnoses to be exchanged along with other data within the ADT. This will also allow the Administrative part e.g. billing where the ICD codes are also required when billing for prescriptions to have the information exchanged simultaneously when e-prescribing. PROCEDURAL CODES Within the e-prescribing as stated earlier, there will be need for procedural codes to be included in some situations where certain medications are components of such procedures. Such an example includes the epidural steroid injection, where different types of steroids will need to be injected into the spine. There are also procedures where some medications are also utilized in enhancing the procedures. In such instances, the e-prescribing may require being able to identify the procedure along with the medication. For procedures the Current Procedural Terminology (CPT) code will be adopted. This was developed in 1966 by the American Medical Association and updated annually allowing it to provide a pre-coordinated coding scheme for diagnostic and therapeutic procedures towards billing and reimbursement. The differentiation between codes is to identify specific codes and the cost differences. It remains the most widely accepted standard terminology in the US by federal and private insurance for third-party reimbursement while reporting physician procedures and services. The continued adoption of the CPT for now when mapped to the other recommended codes will allow the full integration of billing with specific diseases being treated. The use of the CPT codes during e-prescribing will therefore meet the ability for it to be exchanged towards not just defining the specific use of medications with a procedure but also within the ADT by the pharmacy benefits management system towards Prior Authorization checking with the formulary and benefits requirements as certain medications will only be approved for specific FDA indicated use and not necessary off-labeled use. PHARMACY To enable the transmission and exchange of the needed prescription with the different names of the medications, form and doses, the RxNorm standard will be used. The standard is also used in conjunction for data pertaining to medical history, formulary and benefits and fill status notification (RxFill). The RxNorm is based on collaboration between FDA, National Library of Medicine, VA and the pharmacy knowledge based vendor. It is provided to the public as part of the Unified Medical Language System (UMLS) and allows mapping between NDC codes, VA national drug filed and other proprietary drug terminologies. It provides standard names for clinical drugs and dose forms as given to a patient and also provides links from clinical drugs to their brand and generic forms, active ingredients, drug components and related brand names. The National Drug Codes (NDC) for certain drug products especially where there are multiple NDCs for a single product are linked to the RxNorm for that particular drug It is becoming the standard in this field for clinical drug terminology and allows integration into other terminologies enabling monitoring of drug usage for specific disease patterns and allows monitoring of reactions to such medications. In combination with all the other standards stated and described above, the RxNorm can be integrated and mapped with the other standards stated above towards exchange of information using the HL7 and the NCPDPD SCRIPT as messaging standard and therefore allowing medication being e-prescribed to be checked against other relevant information pertaining to the patient e.g. one who is undergoing a procedure that requires a specific eprescribed medication with some medical conditions and allergies that may lead to contraindication to using such a medication or requirement of the laboratory renal clearance that may require the adjustment of the dose of such a medication. For formulary and benefits information is exchanged using the NCPDP Formulary and benefits standard providing prescribers with information from a plan about a patient’s drug coverage at the point of care including general formulary data, formulary status of individual drugs, preferred alternatives (including any coverage restrictions) and co-payments. The Exchange of Medication History is through the NCPDP Prescriber/Pharmacist interface SCRIPT standard and is sometimes referred to as the “Medication History Standard” providing a uniform ways for prescribers and payers to exchange the list of medications that the patient is taking and therefore the potential drug interactions. Structured and Codified Sig standard is based on the NCPDP Structured and Codified Sig Standard providing a standard structured code set for patient instructions on taking the medications which is currently being provided as free text at the end of a prescription. It is still being worked on as per field definitions and examples, field naming conventions and clarifications of field use as it is found not yet up to par for example with topical medications, etc. 7 Team 7 Project E-Prescribing The standard for the Fill Status Notifications or RxFill is the NCPDP SCRIPT as discussed earlier as it allows a pharmacy to notify a prescriber when the prescription is picked by the patient (dispensed), partially dispensed or not dispensed thereby allowing the prescriber to be aware of the adherence to the medications by the patients especially in chronic diseases; This process also allows the prevention of abuse, conversion and fraud in dispensing the medications. There are concerns that providers may feel inundated with too much information as per the use of this standard and may therefore create unnecessary administrative and financial burden on the prescribers and dispensers. The Prior Authorization Standard was based on the Accredited Standard Committee (ASC) X12N 275 version 4010 with HL7 and ASC X12N 278 allowing verification of prior authorization and certification from a plan that the patient meets coverage criteria for a particular drug. It is a very complex and difficult standard to implement because it involves many other standards and multiple payer requirements making it cumbersome, confusing and requiring expertise that may make it difficult for adoption. Potential Challenges. Security is a big issue. In order to maintain HIPAA compliance, the vendor has to make sure that the patient specific information contained in the prescription cannot be intercepted and accessed while being transmitted from the physician’s office to the pharmacy. Monitoring has to be put in place to make sure security is still intact. Security companies can be hired to test the integrity of your system by trying to penetrate it. If the application is scanning a paper prescription and sending that image to a receiving system, then the office has to make sure they have a process in place to keep those originals from leaving the office and being filled illegally; or the information contained on them falling into the wrong hands. Another challenge is system compatibility. The vendor of the application the physician is using has to use a standard that is compatible with the application the receiving pharmacy is using so that prescription is received in the same format that the pharmacy’s system can interpret. This may be more of a challenge for a PBM since it could be hundreds of miles away from the patients whose prescriptions it is filling. The PBM could be receiving electronic prescriptions from as many different applications as are commercially available. This is also a possibility with a community pharmacy, but because of the technical expertise and cost involved, hospitals and medical centers are partnering with their attending physicians and aiding them in setting up these systems. As a result, the practices in the area are more likely to be using the same application. If the applications are set up to send and receive the contents of the prescription as an HL7 message instead of an image of a paper prescription, then the applications also have to make sure that the elements in the sender’s system match up with the receiver’s system. The systems will also have to have a process in place in order to handle if it is sent code not in its tables. For example, if one system isn’t as up to date regarding NDC codes or drug names as the other; the receiving application needs to know how to handle that message. Physicians need to remove themselves from the concept of free-texting the elements of a prescription onto a piece of paper and become familiar with the concept of Discrete SIGS. Discrete Sigs will separate the "Sig", or components of the prescription, into discrete fields. There will be a field for dose, one for route and another for frequency. Prescribers will also be presented with a list of possible drug choices depending on how much or little of the drug name they enter into the field. This results in more button-clicking rather than typing or handwriting words and numbers. Prescribers could look upon this change as something that slows them down as opposed to a safety feature due to increased legibility. These systems will require routine maintenance from time to time. Schedules will have to be set up so as to minimize inconvenience to the physician, the pharmacy, and the patient. The physician and the pharmacy need to have downtime procedures in place for when an emergency downtime happens. Procedures will have to be created explaining to the staff what to do and who is responsible for various actions as a result of specific scenarios (office computer down, power outage, computer infection, etc.).Before the practice, pharmacy, or PBM goes live with the application, those employees that will be handling the e-prescriptions will have to be trained on their application. A policy and procedure will have to be created to handle training new employees, as well as a way for current employees to stay proficient in using the application. The physician’s application has to be able to send prescriptions real time, as opposed to batch mode to make sure the patient doesn’t get to the pharmacy before this prescription does. The pharmacy has to make sure that the electronic prescriptions received can be easily transferred to whatever 8 Team 7 Project E-Prescribing storage solution the store is using, in a format that will allow the pharmacy to be able to produce that information if required as a result of an inquiry from and state or federal agency. The applications have to be able to handle any CPT and/or ICD9 codes that need to be sent along to third party payers. Customers of these e-prescription applications have to make sure that their vendor can upgrade their system as regulations and requirements for eprescribing changes via legislation in a timely enough fashion to keep the customer from incurring any penalties from not meeting mandated timelines. Conclusion E-prescribing is a process which employs the exchange of patient, prescription, provider and benefit data as part of the automated transmission and filling of prescriptions. The accuracy and success of e-prescribing depends on the presence of semantic interoperability in which all parties and systems apply the same definition and meaning to various terms. The process has several key groups of stakeholders which represent large groups of individuals between patients, prescribers, pharmacies and vendors. During the process of e-prescribing a number of terminologies are employed based on the variety of data types represented. There are challenges present with eprescribing, as with most technologies which deal with sensitive patient data. The use of e-prescribing will increase as experience grows and its use is included in expectations such as Meaningful Use achievement and the development of Accountable Care Organizations. This expansion will make the use of standards and structured terminologies even more important. 9 Team 7 Project E-Prescribing References: National Council for Prescription Drug Programs (NDPD) retrieved from http://www.ncpdp.org/pdf/Eprescribing_fact_sheet.pdf Centers for Medicare and Medicaid Services (CMS) retrieved from: https://www.cms.gov/EPrescribing/ Mead, C.N. (2006). Data interchange standards in health care IT--computable semantic interoperability: Now possible but still difficult, do we really need a better mousetrap? Journal of Healthcare Informatics Management, 20(1), 71–78. e-Prescribing Process Flow and Conceptual Data Flow Overview. Slideshare.net. Retrieved February 18, 2012 from: http://www.slideshare.net/datacenters/eprescribing-overview ICD-10-CM official Coding handbook: http://www.cms.gov/ICD10/Downloads/7_Guidelines10cm2010.pdf Current Procedural Terminology: http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-yourpractice/coding-billing-insurance/cpt.page E-prescribing - CMS Report to Congress:- https://www.cms.gov/EPrescribing/.../E-RxReporttoCongress.pdf E-prescribing Standards:- endingthedocumentgame.gov/PDFs/ePrescribing.pdf RxNorm: http://www.nlm.nih.gov/research/umls/rxnorm/ HL7 Messaging Standards: http://www.hl7.org The National Council for Prescription Drug Programs retrieved from http://www.ncpdp.org Sokol DK, Hettige S (2006). Poor Handwriting Remains a Significant Problem iin Medicine. Journal of the Royal Society of Medicine. 99, 645.