Re: Health Information Technology Patient Safety Action and Surveillance Plan for Public Comment, FY 2013-2015



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VIA Electronic Submission to ONC.Policy@hhs.gov February 1, 2013 Peter Ashkenaz Director, Communications Office of the National Coordinator for Health Information Technology (ONC) Department of Health and Human Services 200 Independence Ave., SW Washington, DC 20201 Re: Health Information Technology Patient Safety Action and Surveillance Plan for Public Comment, FY 2013-2015 Dear Mr. Ashenaz: On behalf of the membership of the Pharmacy e-health Information Technology Collaborative (Collaborative), we are pleased respond to the Health Information Patient Safety and Surveillance Plan published in the December 21, 2012. The Pharmacy e-hit Collaborative is supportive of the safety and surveillance plan and the plans goals to improve the safety of health information technology (HIT) through safely designed and implemented systems. Pharmacists are ineligible for Electronic Health Records (EHR) incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with Eligible Professionals (EPs). As indicated throughout our comments, pharmacists are EHR users; however, they are ineligible for Centers for Medicare & Medicaid (CMS) Meaningful Use of EHR incentives. Pharmacists provide patient-centered care and services, maintain various patient care records, and as part of the integrated health care team, they are directly involved with patients in various practice settings, particularly with a patient s medication action plan. Pharmacists are in a strategic position to help improve patient safety, especially, through HIT and EHR. Also as noted our comments, the Collaborative is an excellent and knowledgeable resource, especially, concerning the impact of EHR technology on the pharmacy industry. We strongly encourage you to include the Collaborative in discussions in this area. The following are our comments concerning the patient Health Information Patient Safety and Surveillance Plan: Pharmacy e-health Information Technology Collaborative 401 Holland Lane Suite 702 Alexandria, VA, 22314 www.pharmacyhit.org 703-599-5051

1) EHR adoption in the past has been low. This means the lack of patient harm attributed to health IT may not be due to how safe health IT is but to its lack of use. (Page 5) Comment: Although pharmacist EHR adoption is low, the Pharmacy e-hit Collaborative supports the adoption and use of EHR to improve patient care and safety. As pharmacists adopt EHR technology, they will help improve patient safety. One of the reasons for low EHR adoption at this stage is that pharmacists are not eligible for the incentives under CMS EHR Incentive Program. Including pharmacists in CMS program would remove a barrier to ensuring a fully, integrated health care team approach with the incentive program and increase a more standardized adoption of EHR technology. Pharmacists deal with and can affect patient safety issues through the adoption and use of HIT and through the patient-centered care services they provide. Because of their frequent access to patients and medications in various pharmacy practice settings, pharmacists are in a strategic position to enhance patient safety. 2) HHS has already taken steps toward improving patient safety through health IT. For example, EHR payment incentive requirements such as maintaining lists of patient medications, allergies, and problems, and the use of computerized provider order entry (CPOE) are tangible steps towards growing a safety infrastructure. (Page 8) Comment: As noted in our first comment, pharmacists are not receiving incentives under CMS EHR Incentive program and should be included as EPs for this program. Pharmacists currently maintain active lists of their patients medications, allergies, and problems related to specific medications. Under new provisions for Medicare Part D for medication therapy management that became effective on January 1, pharmacists are required to provide patients with an annual medication review. Patients will use the information provided as a means to ensure that their medications are used appropriately and to follow up with their pharmacists and providers regarding these medications. Having the electronic information available by using Consolidated Clinical Document Architecture (ccda) structured documents, patients will have the ability to not only print the information provided in a human readable form, but they will also be able to integrate the structured data into their personal electronic health records. The Collaborative is working with standards development organizations to identify between patient-generated data and provider-generated data. 2

3) Continuously improve the safety of health IT: The purpose of this objective is to ensure that when physicians, nurses, therapists, and other clinical users of health IT care for patients, they are using a safely designed and implemented system, are properly informed and trained to use the health IT system, are using that system safely, and have processes in place to identify and correct unsafe conditions or unsafe uses of health IT. (Page 8) Comment: The Pharmacy e-hit Collaborative recommends that pharmacists be included in this objective. The Collaborative believes that improving quality, safety, and reducing health disparities through the use of HIT is critically important and that pharmacists are in a strategic position to play a vital role in this regard. 4) In addition to the code of conduct, ONC will work with private organizations, developers, and providers to make more health IT related safety information available. Workgroups or common interest groups that focus on health IT and safety could be established at professional forums, such as the Healthcare Information and Management Systems Society (HIMSS) or the American Medical Informatics Association (AMIA), to help educate developers and users on how to identify and report adverse events, the benefits of using Common Formats, and working with PSOs. (Page 12) Comment: We recommend ONC work with the Pharmacy e-hit Collaborative as one of the organizations listed to make more HIT related safety information available. The Collaborative was formed in September 2010 by nine pharmacy professional associations, representing over 250,000 members, to ensure that pharmacist-provided patient care services are integrated into the National HIT interoperable framework. The Collaborative s founding organizations represent pharmacists in all patient care settings and other facets of pharmacy, including pharmacy education and pharmacy education accreditation. The Collaborative s associate members represent e-prescribing networks, a standards development organization, transaction processing networks, pharmacy companies, system vendors, and other organizations that support pharmacists services. 5) Health IT products provide inherent safety advantages over paper records in that patient record is rarely physically lost, is legible, is rapidly available in multiple locations, and often provides clinical decision support. But just as paper records can be incomplete, inaccurate, and inaccessible, so can electronic records, compromising their safe use. ONC plans to work with its federal advisory committees determine ways to improve clinical documentation, thereby, reducing the risk that records will be inaccessible or their accuracy or completeness compromised. (Page 17) Comment: Pharmacists maintain various types of patient care records. The Pharmacy e-hit Collaborative supports the use and maintenance of electronic records. We recommend that the Collaborative be included in discussions concerning ways to improve documentation and to 3

ensure consistency in standards that may be used for the completeness, accuracy, accessibility, security, and safe usage of these records. 6) Investigate and take corrective action, when necessary, to address serious adverse events or unsafe conditions involving EHR technology: HHS is also interested in working with private sector organizations that have the ability to investigate, take corrective actions, and publicly report on their analysis of events. (Page 19) Comment: As noted throughout our comments, the Pharmacy e-hit Collaborative is an excellent resource and can help HHS in this regard. Again, we strongly encourage ONC to include the Collaborative in discussions with regard to investigative, corrective actions, and reporting on analyses of adverse events involving EHR technology. Formed in the fall of 2010, the Collaborative s focus is to assure the meaningful use (MU) of standardized EHR that supports safe, efficient, and effective medication use, continuity of care, and provides access to the patient-care services of pharmacists with other members of the inter-professional patient care team. The Collaborative seeks to ensure pharmacist-provided patient care services are integrated into the National HIT interoperable framework. The Collaborative s founding organizations represent pharmacists in all patient care settings and other facets of pharmacy, including pharmacy education and pharmacy education accreditation. The Collaborative s Associate Members represent e-prescribing networks, a standards development organization, transaction processing networks, pharmacy companies, system vendors and other organizations that support pharmacists services. The Collaborative was founded by nine pharmacy professional associations representing over 250,000 members and includes six associate members from other pharmacy related organizations. For additional information, visit www.pharmacyhit.org ***** On behalf of the Pharmacy e-hit Collaborative, thank you again for the opportunity to comment on the Definition of Meaningful Use of Stage 3 Electronic Health Records proposal. For more information, contact Shelly Spiro, Executive Director, Pharmacy e-hit Collaborative at shelly@pharmacyhit.org. Respectfully submitted, Shelly Spiro Executive Director, Collaborative 4

Shelly Spiro, RPh, FASCP Executive Director Pharmacy e-health Information Technology Collaborative shelly@pharmacyhit.org Mark N. Brueckl, RPh, MBA Assistant Director, Pharmacy Affairs Academy of Managed Care Pharmacy mbrueckl@amcp.org Mike Rouse B.Pharm (Hons); MPS Assistant Executive Director, Professional Affairs and Director, International Services Accreditation Council for Pharmacy Education (ACPE) mrouse@acpe-accredit.org William Lang, MPH VP Policy and Advocacy American Association of Colleges of Pharmacy wlang@aacp.org C. Edwin Webb, Pharm.D., MPH Associate Executive Director Director, Government & Professional Affairs American College of Clinical Pharmacy ewebb@accp.com Marcie Bough, PharmD Senior Director, Government Affairs American Pharmacists Association mbough@aphanet.org Lynne Batshon Director, Policy & Advocacy American Society of Consultant Pharmacists Lbatshon@ascp.com Christopher J. Topoleski Director, Federal Regulatory Affairs American Society of Health-System Pharmacists ctopoleski@ashp.org Marc J. Ricker CMO IQware Solutions mricker@iqwaresolutions.com Kim Swiger, RPh Vice President, Pharmacy Services Mirixa Corporation kswiger@mirixa.com Rebecca Snead Executive Vice President and CEO National Alliance of State Pharmacy Associations rsnead@naspa.us Ronna B. Hauser, PharmD VP Policy and Regulatory Affairs National Community Pharmacists Association (NCPA) ronna.hauser@ncpanet.org Lynne Gilbertson VP Standards Development National Council for Prescription Drug Programs (NCPDP) lgilbertson@ncpdp.org Stephen Mullenix. RPh Sr VP, Communications & Industry Relations National Council for Prescription Drug Programs (NCPDP) smullenix@ncpdp.org 5

Patty Kumbera, RPh Chief Operating Officer Outcomes pkumbera@outcomesmtm.com Roger Pinsonneault, R.Ph. Vice President, Business Development RelayHealth Pharmacy Roger.Pinsonneault@RelayHealth.com Michael E. Coughlin President, CEO and CFO ScriptPro mike@scriptpro.com Ken Whittemore, Jr., RPh, MBA Senior VP, Professional & Regulatory Affairs Surescripts ken.whittemore@surescripts.com 6