Pharmacy Jurisprudence, L.L.C. Our annual continuing education offering is written for specifically for pharmacists in the State of Ohio, but is approved for credit in other states as well. Electronic Transmission of Prescriptions in Ohio Accreditations: This continuing pharmacy education activity has been approved by the Ohio State Board of Pharmacy for Ohio Board-approved jurisprudence and by ACPE for law-related continuing education for pharmacists in all other states. Ohio Program No.: 036-350-10-001-H03-P Contact Hour(s): 1.0 Approval Date: March 23, 2010 Expiration Date: March 22, 2012 Cost: $15.00 Just to get you thinking 1. What is an electronic prescription transmission system in Ohio? 2. What is a qualified e-prescribing system under federal rule? Select CE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Pharmacy Jurisprudence, a division of Select CE, presents the following continuing pharmacy education (CPE) program for pharmacists and pharmacy technicians.
Program Title: Ohio Program No.: ACPE Program No.: Target Audience: Electronic Transmission of Prescriptions in Ohio 036-350-10-001-H03 487-000-10-001-H03-P knowledge-based activity or 487-000-10-001-H03-T knowledge-based activity All Pharmacists in Ohio Expiration Date: March 22, 2012 Accreditations: This continuing education activity is approved by the Ohio State Board of Pharmacy for 1.0 contact hours, or 0.10 C.E.U. s, of continuing pharmacy education in Board-approved jurisprudence. This program is also approved by ACPE for pharmacists and pharmacy technicians in all 50 states under our trade name Select CE. Select CE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Media: Enduring print material, and at www.pharmacyjurisprudence.com and interactive test-taking at www.selectce.org. Fee Information: $15.00 Estimated Time to Complete the Activity: 60 minutes Procedures: To receive a Statement of Credit, read this program, complete the post-test questions and evaluation on the Answer Sheet, and either: i) mail the Answer Sheet and the program fee of $15.00 to us. You will receive a Statement of Credit mailed to you within 2 weeks. Checks or money orders are encouraged. Mail to: Pharmacy Jurisprudence, P.O. Box 21186, Columbus, Ohio 43221-0186. Refunds are not provided. or ii) use our online test-taking website www.selectce.org. Follow the instructions on the website, using any major credit card to pay the $15 program fee. Upon passing the test, you will receive immediate confirmation via email, and your official Statement of Credit will be sent via U.S. mail within 5 days but in most cases within 2 days. Refunds are not provided, unless you mistakenly make too many online payments or some such other online snafu. A minimum score of 70% is required to earn a Statement of Credit. Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 2
Faculty: Patricia A. Nussle, R.Ph., J.D., is the founder of Pharmacy Jurisprudence and Select CE. She is also a healthcare attorney who has written and published continuing education programs in pharmacy law and nursing law for over 200,000 healthcare professionals since 2001. Disclosure of Commercialism, Unlabeled Uses, Bias, Conflicts of Interest: Prior to the delivery of the content, we will disclose any commercial support, and we do so here: No commercial support was requested or accepted for developing or presenting this program. All development, printing and mailing costs come solely from your program fees. No unlabeled uses of drugs are discussed in this program. Faculty Patricia A. Nussle, Pharmacy Jurisprudence and Select CE have no real, apparent, or potential conflicts of interest or financial relationships to disclose, other than that Patricia A. Nussle is the owner of Pharmacy Jurisprudence and Select CE, and she warrants that she presents this information fairly and without bias. Objectives: At the conclusion of this program, pharmacists should be able to: 1. identify key aspects of electronic prescription transmission systems in Ohio; and 2. identify key aspects of qualified e-prescribing systems under federal rule. Objectives: At the conclusion of this program, technicians should be able to: 1. identify key aspects of electronic prescription transmission systems in Ohio; and 2. identify key aspects of qualified e-prescribing systems under federal rule. Important Note: Colleagues, this is a continuing education program. It is not legal advice. Do not rely on this CPE program as legal authority. If you do have a legal problem or question, please consult an attorney experienced in pharmacy law matters to discuss your specific situation. Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 3
Electronic Transmission of Prescriptions in Ohio The use of electronic prescribing by physicians is likely to increase dramatically in the coming years due to incentives in the federal government s stimulus package. The American Recovery and Reinvestment Act of 2009 ( ARRA ) provides incentive payments to Question 1: physicians, hospitals, and nursing facilities for the adoption and The federal government s implementation of health information stimulus package technology ( HIT ), including electronic encourages e-prescribing by: health records ( EHRs ), and a penalty for not adopting this technology by 2014. The federal stimulus package calls for up to $63,750 per provider in Medicare/Medicaid reimbursement bonuses for providers who are 'meaningfully using' a certified EHR by 2011. Meaningful use of an EHR includes e-prescribing, connection with other EHR s, and reporting of clinical quality measures. Other advantages to providers who implement qualified e-prescribing system: a. incentivizing providers with bonuses of up to 2% of Medicare Part B charges if implemented by 2010; b. penalizing providers with fees of up to 2% of Medicare Part B charges if not implemented by 2014; c. both of the above are true. The Medicare bonus for using qualified e-prescribing systems is 2% for 2009 and 2010 and drops to 1% in 2011 and 2012 of covered Medicare Part B Charges. By 2012, Medicare will begin assessing financial penalties of 1% to physicians that fail to implement electronic prescribing (erx). In 2013 the penalty increases to 1.5% and 2% by 2014. And so, the race is on to implement qualified e-prescribing systems. However, the federal government and the state government have different requirements for what constitutes an acceptable system, and even different terminology for such a system. The Ohio State Board of Pharmacy s (the Board s ) term is electronic prescription transmission system pursuant to an approval process that is not set out in rule or statute, and yet this is the floor that must be met in order for an electronic prescription to be valid. The federal government s term is qualified e-prescribing system, and a provider must Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 4
report on its use to the Centers for Medicare and Medicaid in order to receive incentives and avoid penalties. A. Ohio: Electronic Prescription Transmission Systems First, let s start with the definition of an electronic prescription in Ohio. Ohio Administrative Code 4729-5-21- Manner of processing a prescription. (F) Electronic prescriptions: (1) Electronic prescriptions may be received by a pharmacy if the electronic prescription transmission system has been approved by the state board of pharmacy. (2) A pharmacy desiring to receive electronic prescriptions directly into its computer system must obtain approval from the state board of pharmacy. The original prescription information received from the prescriber must be saved and a hardcopy prescription must be printed to document the dispensing. The hardcopy prescription must be filed serially in the prescription file pursuant to rule 4729-5-09 of the Administrative Code. The state s regulation does not define what an electronic prescription is, but instead defines an electronic prescription in terms of how it is received by the pharmacy, i.e., via an electronic prescription transmission system that is Board approved. So, let s review the Board s compliance memo from November 2009. It is below in its entirety, and ends after the list of approvable systems. Electronic Prescription Transmission Systems (11/03/09) Electronic prescription transmission systems allow prescriptions to be sent electronically from a prescriber to a pharmacy. The prescriber can send the prescription directly from his/her computer to a pharmacy computer or facsimile machine. Some of the systems are office-based, some are web-based, and some use a switching station to route the prescription to the pharmacy. The officebased systems allow the prescriber to send a prescription electronically directly from his/her office to the pharmacy. The web-based systems allow the prescriber to log onto a website, enter a prescription, and the website sends the prescription to the pharmacy. Systems utilizing a switching station allow the prescriber to enter a prescription that is transmitted to a switching station. The Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 5
switching station identifies the prescriber using specific data elements and then sends the prescription to the pharmacy. Prior approval by the Board of Pharmacy is required for all electronic prescription transmission systems intended to be used in Ohio. The Board approval process includes reviewing that each system has true positive identification of the prescriber sending the prescription as defined in paragraph (N) of Rule 4729-5-01 of the Ohio Administrative Code (OAC), that every system has security and accountability of all confidential information, that the pharmacist receiving the prescription can identify that the system has approvable status with the Board of Pharmacy, and that the pharmacist receiving the prescription can identify that the prescription is legitimate. Some important information you should know about electronic prescription transmission systems: 1. No Schedule II controlled substances shall be sent to a pharmacy using an electronic prescription transmission system. 2. There can be multiple prescriptions, including controlled substances in Schedules III, IV, and V, issued on one prescription blank when using an electronic prescription transmission system to send a prescription to a pharmacy [see OAC Rule 4729-5-13]. However, it should be noted that the DEA currently does not allow for the electronic transmission of controlled substance prescriptions. The DEA does allow the information to be transferred to a pharmacy, but then requires the pharmacist to treat it as an oral prescription. To create an oral prescription the pharmacist must then personally contact the prescriber by telephone and verify the transmitted information. Therefore, due to the increased legal burdens placed on the pharmacist and prescriber, many vendors involved with the transmission of electronic prescriptions have chosen to prohibit the transmission of controlled substance prescriptions at this time. 3. Dispense As Written or DAW does not have to be handwritten on a prescription sent through an electronic prescription transmission system [see Section 4729.38 of the Ohio Revised Code (ORC)]. It does, however, require a positive action by the prescriber to physically select Dispense As Written or DAW when creating an electronic prescription. The electronic prescription transmission system cannot automatically default to "Dispense As Written" or "DAW". 4. You may, or may not, see a signature on a prescription sent to a pharmacy by a prescriber using an electronic prescription transmission system. Electronic signatures are not recognized as a means of positive identification Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 6
and therefore are not required. If a signature is present, the prescription must indicate that the signature was computer-generated. 5. A prescriber may elect to print a prescription from the electronic prescription transmission system in his/her office and give it to the patient to personally present to a pharmacy. The prescription must be issued as per any written prescription [see OAC Rules 4729-5-30 and 4729-5-13]. These prescriptions may contain a Schedule II controlled substance, there can only be one controlled substance per prescription blank, Dispense As Written or DAW must be handwritten, and the actual handwritten signature of the prescriber must be on the prescription. The systems that currently have obtained an approvable status with the Board of Pharmacy are (NOTE: The approvable status applies ONLY to the electronic prescription transmission system and NOT to any other related electronic products, such as an electronic medical record): A4 Health Systems Allmed Allscripts Allscripts erx NOW Allscripts-HealthMatics EHR Allscripts MyWay Alteer Amicore Aprima Athenahealth BlueFish ChartLogic CyberAccess DrFirst e-clinicalworks EHS Emdeon e-mds Epic at Cinc. Children s Epic at Cleveland Clinic Epic at Dayton Children s Epic at Ohio State Epic at Premier Health Center Epic at Tri-Health E-Physician e-referral GEMMS Greenway Medical Health Probe imedica InfoScribeRx InteGreat I-Scribe KeyScribe MedicWare McKesson Horizon Ambulatory Care Medent MedInformatix MedPlus MI-LifeNet MicroMD Misys at Family Practice Assoc. Of Dayton Misys at Greater Cincinnati Cardiovascular Consultants Misys at Northeast Center for Women s Health Misys at The Family Medical Group Mt Carmel/Medical Manager My Practice Community NetPracticeEHRweb at Premiere Medical Partners NetScript NewCrop NextGen OnCallData Practice Partner Pocket Scripts Positive Business Solutions Inc./PBSI-EMR Relay Health RxNT Sage Health SigmaPoint Wellinx Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 7
Question 2: Electronic prescription transmission systems allow prescriptions to be sent electronically from a to a pharmacy. a. pharmacy; b. prescriber; c. pharmacy benefit manager. Question 3: Prior approval by the Board of Pharmacy is required for all electronic prescription transmission systems intended to be used in Ohio. a. True; b. False. Question 4: Board approval process includes reviewing that each system to ensure: a. positive identification of the prescriber; b. security and accountability of all confidential information; c. both of the above are true. Question 5: Board approval process includes reviewing that each system to ensure: a. that the pharmacist receiving the prescription can identify that the system has approvable status with the Board of Pharmacy; b. that the pharmacist receiving the prescription can verify that the prescription is legitimate; c. both of the above are true. Question 6: You receive an electronic prescription at your pharmacy for a 30-day supply of Ritalin with a computer-generated signature of the prescriber, Dr. Techie. Can you fill it? a. Yes, if the electronic prescription transmission system has been approved by the Ohio State Board of Pharmacy; b. No, because all Schedule II electronic prescriptions are invalid; c. Yes, if Dr. Techie calls in a verbal order for it. Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 8
Question 7: You ve sent more than one frazzled parent with excitable child in tow back to Dr. Techie to get a valid prescription for Ritalin. Dr. Techie s office staff has come up with a solution: a staff person prints out an electronic prescription at the office and gets Dr. Techie to sign it in ink. The office staff hands this prescription to the parent, who comes back to your pharmacy with this prescription to be filled. Assuming it meets all other requirements of any written prescription [see OAC Rules 4729-5-30 and 4729-5-13], can you fill it? a. Yes; b. No. Question 8: Same situation as in Question 7, but this time Dr. Techie writes a prescription for a benzodiazepine for the frazzled parent at the bottom portion of the 8.5 x 11 inch piece of paper that the Ritalin prescription is on. Can you fill it? a. No, because such a strange size of prescription paper indicates fraud; b. Yes, because it is hand-written and signed by the Dr. Techie in ink; c. No, because there can be only one controlled substance per prescription blank. B. CMS: Qualified e-prescribing Systems In Ohio, an electronic prescribing system must meet the Ohio State Board of Pharmacy s requirements set forth in the previous section in order to generate valid prescriptions at your pharmacy. Generally the Board s concern revolves around ensuring that the system is technologically secure enough to prevent forged prescriptions. In contrast, the federal government s concern is with improving the quality of patient care. A prescriber's ability to electronically send an accurate, error-free and understandable prescription directly to a pharmacy from the point-of-care - is an important element in improving the quality of patient care, according to http://www.cms.hhs.gov/eprescribing. The federal government s view of electronic prescribing can be seen in its definition of the practice: Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 9
Electronic Prescribing (erx) The transmission, using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan either directly or through an intermediary, including an erx network. Electronic prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser. (Faxes do not qualify as electronic prescribing). This definition is taken from CMS s November 13, 2009 Measure Specifications and Release Notes for erx. Notably, it permits indirect transmissions of prescriptions not directly between the prescriber and the dispensing pharmacy, specifically mentioning pharmacy benefit managers and health plans. Sigh. Why CMS Thinks E-Prescribing Saves Lives and Money: Four Key Components E-prescribing is much more than the simple electronic transmission of a prescription between prescriber and pharmacy, according to the Centers for Medicare and Medicaid Services. In fact, electronic transmission is just one of four key components of full e-prescribing. These four components include: 1. Prescription Options: Full e-prescribing provides physicians with clinical and cost information on prescription options that allows them to better counsel consumers on which medications including generic drugs will be the safest and most affordable choices. This information is provided to prescribers in real time by health plans and pharmacy benefit managers (PBMs). 2. Patient Medication Histories and Safety Alerts: Comprehensive patient medication histories tell prescribers not only what they have prescribed, but what other doctors have prescribed. E-prescribing systems make this crucial information available to doctors in real time so that they can help consumers avoid adverse outcomes from events such as drug-drug interactions. If such problems are detected, full e-prescribing systems automatically send prescribers electronic safety alerts before the prescription is sent to the pharmacy. 3. Pharmacy Options: Information on preferred pharmacy options including both retail and mail-service options tells prescribers which pharmacies will be least expensive for consumers in terms of out-of-pocket costs. Reduced out-ofpocket costs particularly for Medicare beneficiaries with chronic conditions have been shown to increase the likelihood that consumers will take their medication as prescribed. 4. Transmittal to Pharmacy: Electronic data entry and transmittal of the prescription to the pharmacy helps pharmacists to avoid transcription errors due Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 10
to illegible handwriting. It also reduces wait times for patients, since pharmacies can start processing prescriptions immediately after they are written. CMS believes approximately 70 percent of the safety and savings advantages of e-prescribing result from the first three components. What is a Qualified E-Prescribing System? A qualified system is an e-prescribing system or program that is able to perform the following tasks, according to CMS: Generates a complete active medication list using electronic data received from applicable pharmacies and pharmacy benefit managers (PBM), if available. Allows eligible professionals to select medications, print prescriptions, transmit prescriptions electronically and conducts all alerts. Alerts include automated prompts that offer information on the drug being prescribed and warn the prescriber of possible undesirable or unsafe situations such as potentially inappropriate dose or route of administration of the drug, drugdrug interactions, allergy concerns, or warnings/cautions. Provides information on lower cost therapeutically appropriate alternatives, if any. For 2009, a system that can receive tiered formulary information, if available, from the PBM would satisfy this requirement. Provides information on formulary or tiered formulary medications, patient eligibility and authorization requirements received electronically from the patient s drug plan (if available). In addition to the system functionalities mentioned above, the system or program should meet the Part D specifications for messaging that were implemented on April 1, 2009. The likely impact of these federal regulations is this: hospitals will be speeding as fast as possible to get their physicians to adopt e-prescribing systems that qualify as a qualified e-prescribing systems in order to get the 2% bonus and avoid the 2% penalty discussed in the first section of this program. However, each of these e-prescribing systems must also comply with Ohio Board of Pharmacy s application of its electronic prescription transmission systems application process. You can see from the list of approvable systems that the list has grown exponentially. Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 11
As a practicing pharmacist, you should stay abreast of which systems are approvable in Ohio. If not, you risk filling prescriptions that are not legitimate prescriptions. This will subject you to not only Board discipline, but also to the debarment list of the Office of the Inspector General. Once debarred by the OIG, you will not be able to fill a prescription that is paid for in whole or in part by the federal government. Question 9: According to CMS, an electronic prescription includes: a. the transmission of prescription-related information between a prescriber and a PBM; b. the transmission of a prescription-related information between a health plan and PBM; c. both of the above are true. Question 10: CMS s 4 components of e-prescribing are: a. safety; efficacy; accuracy ; pharmacist as the drug expert; b. accuracy; pharmacist as the drug expert; review by a pharmacist of patient medication history and proper dosage; c. prescription options; patient medication history and safety alerts; pharmacy options; transmittal to the pharmacy. Question 11: A qualified e-prescribing system under federal rule is a pre-requisite for: a. payment of bonuses by CMS to prescribers who use such a system; b. penalties by CMS to prescribers who fail to use such a system by 2014; c. both of the above are true. Question 12: A qualified e-prescribing system under federal rule must: a. generate a list of active and discontinued medications; b. allow eligible professionals to select medications, print prescriptions, transmit prescriptions electronically and conduct all alerts; c. allow a pharmacist to complete his/her OBRA 90 requirements. Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 12
Return this ANSWER SHEET with the $15.00 Program Fee payable to: NAME: ADDRESS: CITY, STATE and ZIP: TELEPHONE: EMAIL: Pharmacy Jurisprudence, LLC P.O. Box 21186 Columbus, Ohio 43221-0186 ANSWER SHEET: Electronic Transmission of Prescriptions in Ohio Ohio State Board of Pharmacy Program No.: 036-350-10-001-H03 ACPE Program No.: 487-000-10-001-H03 Expiration Date: March 22, 2012 Circle the answer for each question (questions are imbedded in the program). 1. a b c 7. a b 2. a b c 8. a b c 3. a b 9. a b c 4. a b c 10. a b c 5. a b c 11. a b c 6. a b c 12. a b c After completing this program, I am able to: 13. identify key aspects of electronic prescription transmission systems in Ohio: Yes No 14. identify key aspects of qualified e-prescribing systems under federal rule: Yes No 15. This program was an effective way for me to learn: Yes No 16. I liked the program s format: Yes No 17. This program fostered my mental participation: Yes No 18. This was a user-friendly way for me to learn: Yes No 19. I could sense some commercialism in this program: Yes No If yes, please describe: 20. The faculty quality was: Great OK Needs to Improve 21. The learning material quality was: Great OK Needs to Improve 22. How long did it take to complete this program? 23. Comments welcome: Pharmacy Jurisprudence, L.L.C. and Select CE 2010 All rights reserved. Page 13
Pharmacy Jurisprudence, L.L.C. also doing business outside Ohio as Select CE P.O. Box 21186 Columbus, Ohio 43221-0186 PRSRT STD U.S.POSTAGE PAID COLUMBUS, OH PERMIT NO. 8301 Pharmacists, Look Inside! Approved by the Ohio State Board of Pharmacy and also ACPE. We have more CE programs at www.pharmacyjurisprudence.com or take tests online at www.selectce.org Questions? Call us at (614) 481-8711