Minutes of the July 28-30, 2004 NCVHS Subcommittee on Standards and Security Hearing

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

July 28-30, 2004

Washington, D.C.

Meeting Minutes

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The Subcommittee on Standards and Security of the NCVHS was convened on July 28, 2004 at the Hubert H. Humphrey Building in Washingon, D.C. The meeting was open to the public. Present:

Subcommittee members

• Simon Cohn, M.D., Chair
• Jeff Blair, M.B.A., Vice Chair
• Stanley M. Huff, M.D.
• Harry Reynolds
• Judith Warren Ph.D., R.N.

Absent

• John P. Houston, J.D.

Staff and liaisons

• Maria Friedman, D.B.A., CMS, lead staff
• J. Michael Fitzmaurice, Ph.D., ARHQ
• Kathleen H. Fyffe
• Gail Graham, DVA
• Marjorie S. Greenberg, NCHS
• Debbie Jackson, CDC
• Randy Levin, FDA
• Steve Steindel, Ph.D., CDC
• Marietta Squire CDC, NCHS
• Karen Trudel, CMS

Others

• Edwin Allen, Marc Associates
• Margaret Amatayakul, independent consultant assisting the committee
• Eleni Anagnostiadis, Natl. Assn. of Boards of Pharmacy
• Steve Avey, Foundation for Managed Care Pharmacy
• Andrew Barbash, SOS Rx
• Kristin Bass, Wellpoint
• Brian Bamberger, Medimedia
• Bob Beckley, SureScripts
• Thomas Bizzaro, First DataBank
• Roy Bussowitz, National Association of Chain Drugstores
• Bill Braithwaite, ASTM E31.28 CCR Steering Committee
• Peter Brandt, Pfizer Global Pharmaceuticals
• Jeff Brown, Mayer, Brown and Roehm
• Teri Byrne, RxHub
• Anne Canfield, RX Benefits Coalition
• Carmen Catizone, National Association of Boards of Pharmacy
• David Chess, Project Patient Care
• Emily Conidey, Community Health Funding Report
• Jill Leslie Drell, Walgreens Health Initiatives
• Karen Eckert, Medi-Span
• Carl Fink, Prescription Informatics
• Lynne Gilbertson, National Council for Prescription Drug Programs
• William Gilbertson, National Council for Prescription Drug Programs
• Anders Gilberg, American Medical Association
• Mark Gregory, Kerr Drug, Inc.
• Pat Hamby, McKesson
• Tony Hausner, CMS
• Cynthia Howard, HIPAA
• Charles Jaffee, AstraZeneca
• Greg Johnson, PCMA
• Charles Kennedy, Wellpoint
• David Kilgo, Wal-Mart Stores, Inc.
• Frank Kyle, ADA
• Steven Labkoff, Pfizer Global Pharmaceuticals
• William Lang, Amer Assoc of Colleges of Pharmacy
• Marilyn Zigmund Luke , America’s Health Insurance Plans
• Mike Loman, Health Resources and Services Administration in HHS
• Benjamin Lum, The Pink Sheet
• Clement McDonald, Regenstrief Institute
• Kip MacArthur, Wellpoint
• Eugenia Marcus, American Academy of Pediatrics
• Ross Martin, Pfizer
• Kevin Marvin, American Society of Health System Pharmacists
• Margaret Media, independent consultant and contractor to the Subcommittee
• Ed Millek, Prescription Informatics
• Mark Millikan, Medi-Span
• Sandra Mitchell, John Hopkins Univ.
• Alice Ovite, Johnson & Johnson Health Care Systems
• Phil Rah, Mick Express Groups
• Joseph Raduazzo, Tufts Health Plan
• Bill Rampy, Wal-Mart Stores, Inc.
• Alison Rein, National Consumers League
• Lisa Robin, Federation of State Medical Boards
• Scott Robertson, HL7
• Phil Rothermich, Express Scripts
• Mary Ryan, Medco
• Dan Sanick, Caremark
• Marissa Schlnifer, Academy of Managed Care Pharmacy
• Phillip Scott, National Council for Prescription Drug Programs
• Tony Schueth, Point-of-Care Partners
• David Silke, The Health Strategies Consultancy
• Mike Simko, Walgreens
• Kim Slocum, AstraZeneca
• Leanne Stember, National Council for Prescription Drug Programs
• Thomas Sullivan, ASTM E31.28 CCR Steering Committee
• Terri Swanson, CIGNA Pharmacy Management.
• Jessica Townsend, HRSA
• Michael Weinberger, Johnson & Johnson Healthcare Systems
• Ron Weinert, Walgreens
• Donna Whiteford, Medco Health
• Lonny Wilson, Pharmacy Providers of Oklahoma
• Michele Williamson, National Center for Health Statistics, CDC
• Rochelle Wooly, RxHub.
• Alicia Ziemiecki, Alston and Bird
• Alan Zuckerman, Georgetown University School of Medicine

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EXECUTIVE SUMMARY

INTRODUCTORY COMMENTS, Simon Cohn, M.D. and Jeff Blair

Dr. Cohn acknowledged a letter from Senator Charles Grassley clarifying legislative language and intent of the e-prescribing section of the Medicare Prescription Drug Improvement and Modernization Act (MMA). The Subcommittee will compose a response offering to update the senator on their progress developing recommendations.

Mr. Blair noted this work was in response to MMA charging NCVHS to evaluate, select and recommend e-prescribing standards. Version nine of the work plan was posted on the NCVHS Web site.

FORMULARY ISSUES, Steve Avey, Executive Director, Foundation for Managed Care Pharmacy, Academy of Managed Care Pharmacy

Mr. Avey discussed basics of sound formulary management and the environment in terms of formulary evaluations and guidelines the Academy of Managed Care Pharmacy (AMCP) established for formulary evaluation. He noted reasons expenditures for pharmaceuticals increased annually at a double-digit rate, issues AMCP found with this decision-making environment, and concern about how high co-pay levels could go and their impact on compliance. He said sound formulary management process was vital to sustaining MMA.

CONSUMER PERSPECTIVES

• David Chess, M.D., Executive Director, Project Patient Care
• Alison Rein, MS, Assistant Director, Food and Health Policy, National Consumers League

Dr. Chess expressed concern that most medication formularies were economically driven, did not account for patient needs, and prevented them receiving treatment that was in their best interest. Noting the increasing importance of individualized prescribing as society aged, he asked NCVHS to put patient safety first, study e-prescribing’s impact on patient care outcomes, and establish guidelines to ensure this technology did not become a barrier to care.

Ms. Rein presented an overview of the National Consumers League (NCL) and SOS-Rx Coalition projects. One project developed and promoted a standard personal medication record template patients use to record and track medication use. SOS-Rx also developed a definition and guiding principles establishing a baseline standard and an effort encouraging patient-oriented e-prescribing. Ms. Rein asked NCHVS to acknowledge of workflow and ensure patients can choose pharmacies, review and update medication lists, and self-report.

STATE BOARDS OF MEDICINE, Lisa Robin, Vice President of Leadership, Government Relations, and Policy, Federation of State Medical Boards

Ms. Robin discussed the Federation of State Medical Boards’ (FSMB) model act regulating practice of medicine across state lines and guidelines for Internet prescribing and use in medical practice. FSMB emphasized an appropriate patient/physician relationship must exist before prescribing and dispensing medication. Its National Clearinghouse on Internet Prescribing collects and disseminates information on rogue Internet sites. State medical boards have closed such sites and caused physicians to cease affiliation. FSMB supported H.R. 3880 and S. 2464 protecting patients ordering prescriptions over the Internet.

STATE BOARDS OF PHARMACY

• Carmen Catizone, MS, RPh, DPh, Executive Director and Secretary, National Association of Boards of Pharmacy
• Eleni Anagnostiadis, RPh, Patient Safety Senior Manager, National Association of Boards of Pharmacy

Dr. Catizone discussed the Model State Pharmacy Practice Act and the National Association of Boards of Pharmacy’s (NABP) regulations. State Boards of Pharmacy deal with issues of access to the prescription order, standards for prescriptions and quality care, define entities involved in accessing records, and decisions about medication requiring licensure. NABP worked with SDOs to ensure standards did not conflict with state regulation. Dr. Catizone emphasized federal standards and legislation should not preempt safeguards in state laws.

Dr. Anagnostiadis compared state regulations regarding e-prescribing. E-signature and/or other secure methods of validation were high priorities. Nearly half the states required some form of electronic signature and/or other secure method of validation. Major barriers involve: security, technology, regulations that can not be changed often enough to keep up with evolving technology, and the lengthy and impeding government process for approving regulations. Dr. Anagnostiadis urged NCVHS to elicit from DEA the signature required to transmit controlled substances and highlighted core principles to incorporate into the standard.

PAYER PERSPECTIVE

• Joseph Raduazzo, M.D., Medical Director, Tufts Health Plan
• Charles Kennedy, M.D. Wellpoint

Dr. Raduazzo discussed Tufts Health Plan’s (THP) pilot, noting e-prescribing reduced prescription rejections, decreased errors, and identified non-compliance. He reported a savings of one hour-per-physician/pharmacist-per-day. A lesson learned was “keep it simple.” Implementing was labor intensive, required training, and had to be integrated with existing practice management systems (PMS). Most physicians had no IT budget and focus groups sought reimbursement for using e-prescribing devices. Dr. Raduazzo urged NCVHS to stick with standards MMA put forth, undertake a pilot, and make standards straightforward enough to apply evenly. He advocated a streamlined process for changing standards, formulary benefit information at point of care, and a medical record on a thumb drive or smart card.

Believing technical, business and clinical cases and that concrete, low-level measures would show added value and appropriate ROI on investment, Wellpoint Health Networks’ (WHN) offered physicians wireless connectivity via the Internet to an ASP vendor hooked up to WHN’s PBM and an interface to their PMS. Over 80 percent chose an alternative paperwork-reduction package. WHN initiated outcomes research and cooperated with competitors to include other physicians and health plan data. Dr. Kennedy noted deployment was complicated, time consuming, and interrupted patient visits and revenue. It depended on getting buy off from physicians concerned about ongoing costs and apprehensive health plans providing technology would gain financial concessions. He noted health plans had a lead role in e-prescribing and electronic health records (EHR); barriers were business-oriented. Meaningful deployment required a focus on payment methodologies, biotech and clinical research advances, leverage of data captured, feed back to physicians, and other business processes/ structures gaining ROI.

PHARMACIST PERSPECTIVE

• Kevin Marvin, RPh, Chair, American Society of Health System Pharmacists

Dr. Marvin presented the American Society of Health System Pharmacists’ (ASHSP) views on e-prescribing standards and where standardization was needed. ASHSP supported standards developed in an iterative process with measures to support continuous process improvements without hindering ability to safely and efficiently meet patient’s medication therapy needs. Standards had to develop in a way that existing systems could evolve to meet them.

PHYSICIAN PERSPECTIVE

• Clement McDonald, M.D., Regenstrief Institute

Noting he had few doubts about e-prescribing’s benefits but physicians’ were “slow on the uptake,” Dr. McDonald considered issues from their perspective and how e-prescribing might be made more attractive. He discussed entities that had to be identified for e-prescribing and their issues and suggested building formulary into the prescribing process and a medication profile based on all of a patient’s prescriptions were key benefits for physicians. He recommended providing medication profiles from pharmacies in a single unified view.

OPEN MICROPHONE

Phil Rothermich with Express Scripts noted prior authorization was an exception process to manage expense; removing its barriers could result in health plans not covering those drugs.

Dr. Tom Sullivan from the ASTM E31.28 Continuity of Care Record (CCR) Steering Committee said CCR could be at least a temporary solution.

Cynthia Howard from CMS shared experiences as caregiver and how her mother’s personal health record helped doctors.

AST OVERVIEW OF CONTINUITY OF CARE RECORD INITIATIVE, BIll Braithwaite, M.D., PhD, ASTM E31.28 Continuity of Care Record Steering Committee

Dr. Braithwaite presented the CCR steering committee’s recommendations asking NCVHS to ensure standards for e-prescribing allow integration of existing and future EHR systems; ensure data standards for interoperability are American National Standards Institute (ANSI)-accredited and consensus-based; look to CCR data element standards and CCR and HL7 to issue harmonized versions.

PBM PERSPECTIVE

• Phil Rothermich, Vice President, Business Development, Express Scripts
• Terri Swanson, Chief Information Officer, Cigna Pharmacy Management
• Mary Ryan, RPh, Vice President, Pharmacy Regulatory Group, Medco Health Solutions

Dr. Rothermich depicted RxHub developing standards through industry collaboration using NCPDP, HL7 and X12 standards to leverage work in place. He urged NCVHS to recognize all pharmacies and work with NCPDP to adopt what was needed. He supported a multi-payer solution, noting that by leveraging standards connections could be made in many ways. Dr. Rothermich urged NCVHS to consider the commercial market’s needs. He noted four steps to the prescribing process: preloads, the actual prescribing, fulfillment, and claims processing.

Ms. Swanson told how pre-loads collected information prior to physicians needing to access it, enabling faster, more efficient decision support. Pre-loads “seeded” routers so real-time transactions could navigate the prescribing process. She described each component in the process and how those standards could be leveraged. Cigna rejected pre-adjudication but advocated providing the best information possible up front through formulary and benefit loads. Ms. Swanson stressed the necessity of a national prescriber identifier.

Dr. Ryan advocated existing standards developed by SDOs and others linked with RxHub and transmission of requests and authorization codes. Medco questioned prior authorization or a national payer/ patient identifier for demographics. Dr. Ryan encouraged collaboration to standardize the SIG. She said MMA preemption was broad and overcame problems with state rules and regulations but had to be extended for Medicare Part D. Dr. Ryan said preemptions could overcome restrictions with patient consent and use of intermediaries. She asked NCVHS to be technology neutral in describing signature and focus on system security.

PHARMACEUTICAL MANUFACTURERS’ PERSPECTIVE

• Peter Brandt, Senior Vice President, Pfizer Global Pharmaceuticals
• Michael Weinberger, Executive Director, Prescribing Alliances, Johnson & Johnson Health Care Systems Managed Markets Group
• Charles Jaffee, M.D., Director of Medical Informatics, AstraZeneca

Mr. Brandt emphasized three tenets on e-health: patient first, support without controlling clinical judgment, and integrity of information used in clinical decision-making. Pfizer called for standards: (1) ensuring a zone of autonomy around the physician/patient relationship, (2) ensuring information was properly sourced and sources subject to the rigorous accountability and balance FDA required, (3) for accommodating differentiating features enabling articulating needs at point of care and finding appropriate products, and (4) supporting a structured formulary and automated prior-authorization processes.

Mr. Weinberger cautioned about potential for selective, incomplete presentation of drugs. Drugs should be presented in a single consolidated neutral list and provide all relevant clinical and financial prescribing information. No one should have to navigate multiple screens to view all drug choices. Mr. Weinberger asked NCVHS to consider compliance guidelines and certification standards for vendors and networks that ensure a level playing field for all parties.

Dr. Jaffee noted NCVHS recommendations could serve as a model for other National Health Information Infrastructure (NHII) standards. Deployment could support patient adherence and be a first step in integrating technology into the process of patient care and truly personalized medicine. NCVHS’s recommendations for policy imperatives could substantially alter how therapies were chosen. Dr. Jaffee urged NCVHS to maintain a balance between patient privacy and requirements for access to data for public health use and research. He emphasized safe harbors; funding essential technologies; and encouraging innovation benefiting providers, patients and their families.

PHARMACY PERSPECTIVE

• Lonny Wilson, CEO, Pharmacy Providers of Oklahoma
• David Kilgo, RPh, Director of Third Party Operations and Systems, Wal-Mart Stores
• Mark Gregory, RPh, Vice President Pharmacy & Government Relations, Kerr Drug
• Mike Simko, RPh, Manager, Pharmacy Systems, Walgreens Health Services

Mr. Wilson advocated policy standards ensuring pharmacists’ and physicians’ roles, providing the most cost-effective therapy, and preserving maximum positive outcomes. Policies should eliminate commercial messaging and provide safe, cost-effective treatment. Formulary process should be based on quality of outcome. Policy standards should ensure patient freedom and facilitate collaboration to provide DUR process. Noting community retail pharmacies could no longer afford to fund a disproportionate share of ongoing costs, Mr. Wilson asked that MMA’s financial grant provisions include pharmacies.

Dr. Kilgo advocated mandating DUR, a narrow definition of appropriate messaging, and safeguards ensuring choice of retail pharmacist without financial penalties to patients. He noted fully implemented NCPDP script standard would provide necessary information for the prescription process and meet MMA requirements. Dr. Kilgo identified gaps in the code sets. He asked NCVHS to consider grant money to help practitioners and pharmacists in rural areas upgrade PMSs and proposed time lines and milestones for adoption and phased implementation allowing current functionalities to be a foundation for future enhancements.

Dr. Gregory highlighted community pharmacists’ role, efficiencies and tools utilized in the current dispensing process, and shared their perspective on e-prescribing and standards. He recommended NCVHS: (1) enhance physician adoption with grants for training, purchase and acceptance of the technology, (2) supplement pharmacists’ investment with incentives for adopters, and (3) fund entities to measure outcomes gauging safety and efficiency.

Dr. Simko noted lack of an accepted, non-proprietary SIG prescription database, urged NCVHS to adopt the National Drug Code (NDC) as a standard for medication identification, and advocated the generic product indicator (GPI). Physicians should (1) have access to neutral, unbiased information and covered outpatient medications; and (2) readily view necessary information (including information about preferred/non-preferred drugs on and off formulary) without navigating multiple screens. Information should be fact-based and transparent, banners/advertisements identified, sources and incentive payments disclosed, and benefit structures depicted fairly.

GUEST TESTIFIER, Eugenia Marcus, M.D., FAAP, Executive Committee, Steering Committee on Clinical Information Technology, Massachusetts Branch, American Academy of Pediatrics

Dr. Marcus outlined ways in which children’s prescribing needs differed from adults. Too often, pediatricians had to modify products designed for adults and frequently that did not work. Noting there were nuances to consider, she urged NCVHS to involve end-user clinicians.

OPEN MICROPHONE

Dr. Braithwaite from the ASTM E31.28 CCR Steering Committee noted ubiquitous secure connectivity was needed and would require standards not yet available. Patients not comfortable with their doctor receiving fill status notifications might consider forcing choice in the physician’s office a privacy rights issue.

Bob Beckley with SureScripts noted security was in place for routing mechanisms. He suggested levels of security that might be dictated were covered under HIPAA.

Judith Warren pointed out that access to Internet was a problem in some frontier-level areas.

Tony Schueth with Point-of-Care Partners noted barriers to e-prescribing had been overcome but prioritization was needed to overcome remaining obstacles. He suggested encouraging adoption with incentives and assistance in purchasing. He recommended: adopting NCPDP SCRIPT, HL7 orders and crosswalks; interfaces between PMS and e-prescribing or EHR; MMA preemption; HL7 standards for CPOE systems in hospitals with source systems; and identifiers.

Ross Martin from Pfizer contended prior authorization was largely a tool to obstruct behavior. He suggested it was inappropriate to ask clinically questions about prior authorization that were uncodable according to HL7-supported vocabularies.

Mary Ryan with Medco recommended not delaying phase one for the two percent of the prescriptions dispensed that was prior authorizations.

Dr. J. Michael Fitzmaurice from DVA emphasized balancing between acting now and having legacy systems built with no way to put in functionality because of all the variables that would have to change.

Dr. Sullivan from the ASTM E31.28 CCR Steering Committee encouraged NCVHS to invite practicing physicians to hearings to ensure an understanding of their work flow and patients’ needs.

Teri Byrne from RxHub suggested that requests to set standards for workflow or functional standards be extended beyond physicians to pharmacy software and other players.

Dr. Cohn read an excerpt from Senator Grassley’s letter reminding the Subcommittee of MMA provisions underlying intent.

OVERVIEW OF LIST OF REQUIREMENTS/GAPS TO BE SENT TO SDOS AND TERMINOLOGY DEVELOPERS AND SUBCOMMITTEE, Margret Amatayakul, independent consultant assisting the committee

Ms. Amatayakul presented an overview considering information flows related to e-prescribing and identified standards and gaps.

ADDITIONAL SUBCOMMITTEE DISCUSSION, Simon Cohn, M.D. and Jeff Blair

Participants considering information flows related to e-prescribing and identified standards and gaps. Members honed an analysis working document identifying needs, gaps and issues to be shared with SDOs, terminology developers and others along with an initial list of low-hanging fruit. Next steps involve cogitating on the next version Ms. Amatayakul will e-mail by early next week and discussing further modifications and improvements. A conference call was scheduled for August 4.

Planning for Next Meeting, Simon Cohn, M.D.

Members discussed the August 17-19 hearings confirming the right interests were represented to capture a comprehensive view linked to perceived gaps and recommendations. Testimony was limited to a day-and-a-half to allow time for further Subcommittee discussions. Hopefully, an initial set of recommendations will be shared with the full NCVHS in September.

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DETAILED SUMMARY

The details of all presentations and letters drafted can be found in the meeting transcript posted on the NCVHS Web site, ncvhs.hhs.gov

-DAY ONE-

INTRODUCTORY COMMENTS, Simon Cohn, M.D. and Jeff Blair

Dr. Cohn acknowledged a letter from Senator Charles Grassley clarifying legislative language and intent of the e-prescribing section of MMA. The Subcommittee will compose a response offering to update the senator on their progress developing recommendations.

Mr. Blair noted the Medicare Prescription Drug Improvement and Modernization Act (MMA) directed NCVHS to evaluate and make recommendations on e-prescribing standards. Version nine of their work plan was available on the NCVHS Web site. NCVHS aimed to give their initial set of e-prescribing recommendations to the Secretary in September, a second set in March. Electronic-signatures (e-signatures) and other issues that could not be covered by September would be deferred. Mr. Blair acknowledged the contributions of Margaret Amatayakul, a consultant assisting the Subcommittee.

FORMULARY ISSUES, Steve Avey, Executive Director, Foundation for Managed Care Pharmacy, Academy of Managed Care Pharmacy

Mr. Avey noted the variety of tiers medications fall into and that formulary had become a determination of the levels at which drugs were covered. Properly designed and implemented formularies could establish rational, clinically appropriate, safe and cost effective drug therapy while supporting an affordable, sustainable benefit. Mr. Avey emphasized that a sound formulary management process was vital to sustaining MMA long term.

He described how a Pharmacy and Therapeutics (P&T) Committee composed of physicians, pharmacists and other health care professionals evaluated medications for inclusion on the formulary and defined at which tier some medications would be covered. He emphasized communicating to prescribers changes in a formulary. Periodically P&Ts assess therapeutic categories, consider influences of new medications, and develop strategies to make non-covered medications accessible in another format. Mr. Avey emphasized that the system needed to inform physicians and pharmacists about coverage for specific medications and explain to plan members how a formulary worked, medications were added, and the rationale for inclusion.

He noted three reasons expenditures for pharmaceuticals increased annually at a double-digit rate. Cost accounted for only a quarter of the increase. The bulk came from changes in utilization and use of multiple medications in regimens (e.g., in 1990 the acceptable cholesterol rate was 240; currently it was below 200). The rest of the increase stemmed from changes in prescribing habits and reliance on newer medications. Employers and payers desire for control over pharmacy expenditures led to a shift in payment to the member, higher co-pays, and renewed emphasis on appropriate utilization. Payers demand to understand the value of new, higher-priced medications and the rationale for decisions.

Mr. Avey noted issues AMCP found with the decision-making environment for formularies: lack of a consistent way in which managed care organizations evaluate medications, insufficient information for quality evaluations, and a need to emphasize the value medications brought rather than solely acquisition cost. Three years ago AMCP developed guidelines calling for the kind of analysis Great Britain, Australia, and Canada required for years. Format for Formulary Submissions incorporate a standardized template to send to manufacturers as an unsolicited request for information needed to make a good decision (e.g., off-label use, outcomes information, unpublished studies, database studies, quality of life, functional status, health economics and modeling studies). Manufacturers develop and submit a dossier to the P&T Committee. The format specifies what information is required and how it should be provided but does not define the decision-making process. Pharmaceutical companies are asked to consider outcomes in clinical trials.

Mr. Avey expressed concern about how high co-pay levels could go and their impact on compliance. He emphasized that in considering a patient’s right to access medications with the highest chance of succeeding and cost consequences of new therapies, sound formulary management was critical.

Discussion

Mr. Avey explained that P&T Committees normally considered formulary change decisions quarterly or monthly. The Managed care community discussed blockbuster drugs coming “down the pike” with the pharmaceutical company months in advance of their launch. Delivering revised formulary to the care giver in a structured standard way that conveyed actual, practical capabilities was a critical step. Noting the e-prescribing community had formularies that enabled a physician to click on a health plan and bring up by disease, state or therapeutic category medications on formulary, he expressed frustration with the difficulty of convincing physicians of e-prescribing’s value and administrative savings.

Mr. Avey said usually databases could be updated weekly if not daily. Organizations download that information onto the physician’s server. Remote databases might be updated nightly or available in real time. He clarified that FDA only allowed pharmaceutical companies to disseminate the information P&Ts gathered to enable PBMs and payers to determine formularies if that information was requested by the organization evaluating the medication. AMCP set up criteria so the information provided to the PBMs and payers would be more scientific and the PMBs’ and payers’ decisions about formularies could be more consistent and defensible. Mr. Avey noted a request for dossiers did not indicate the degree of rigor in the evaluation process. AMCP is evaluating whether PBMs and payers are moving towards greater uniformity or consistency in the formularies created and if AMCP has improved the process or only the information. Preliminary findings will be available by August 2005. Mr. Blair noted this feedback might help NCVHS standardize either the communication or structure of the formularies so prescribers can more readily understood what drugs they can prescribe and how and when exceptions can be processed.

Noting quality of life studies were important but relatively new, subjective and not as accepted, Mr. Avey suggested a more standardized approach to evaluating them. He noted AMCP conducted training programs to train P&T Committees to understand a good quality of life study and was interested in pursuing guidelines and standards that made these studies more plausible and accepted.

Dr. Cohn commented on the difference between having a dossier and understanding how it connected with benefits and the type of programs offered. PBMs and health plans did not get the same costs and contract negotiations with pharmaceutical companies and this impacted final decisions on formulary.

CONSUMER PERSPECTIVES

• David Chess, M.D., Executive Director, Project Patient Care

Dr. Chess cited e-prescribing as an important part of EMR and an efficient avenue for government, pharmacy benefit managers, and managed care organizations to markedly influence what was prescribed for their members. He also cautioned that e-prescribing presented significant opportunity for abuse.

Dr. Chess expressed concern that most medication formularies were economically driven, failed to account for individual patient needs, and created barriers to individual patients receiving the treatment that was in their best interest. He noted this was particularly significant with chronic and multiple active conditions. He pointed out that, as society continued to age and chronic disease and co-morbidities became the rule, individualized prescribing would be increasingly important. A Harris Interactive study sponsored by PPC found over 12 percent of adults 50 (8.9 million people) and older with chronic disease had one medication switch each year. Some 33 percent had an adverse reaction: the medication did not work for 13 percent; 22 percent had untoward side effects. More than half with adverse reactions said the switch resulted in a moderate-to-severe event. About a third required more medication to treat the side effect; 18 percent required an urgent physician visit; 14 percent ended up in the emergency room; 11 percent were hospitalized. Dr. Chess emphasized that, as a national prescription plan rolled out, the effect of formularies in switching medications on people with chronic disease had not been studied as a system change. He asked NCVHS to put patient safety first, study the impact of e-prescribing on patient care outcomes, and establish guidelines to ensure this new technology did not become another barrier to care.

CONSUMER PERSPECTIVES

• Alison Rein, MS, Assistant Director, Food and Health Policy, National Consumers League

Ms. Rein discussed two projects of the SOS-Rx Coalition, a collaboration initiated by NCL dedicated to promoting outpatient medication safety. One project develops and promotes a standard personal medication record template patients can use to record and track medication use, including prescription and over-the-counter (OTC) drugs, vitamins and herbal supplements. The effort’s guiding principle is consumers have a role in ensuring a complete, accurate, updated list of medications and supplements is available to medical care providers, maximizing therapeutic benefit and minimizing adverse events. The effort focuses on the patient’s role in ensuring an accurate medication list is achieved near-term on a broad scale. Ideally the personal medication list will be part of a broader personal health record; the initial step developed a paper-based template to be disseminated in an ongoing campaign.

SOS-Rx initiated a two-tiered effort to accelerate adoption of e-prescribing and developed a definition and guiding principles to establish a baseline standard for patient-oriented e-prescribing. The definition encompasses options ranging from basic clinical decision support to a preferred fully-integrated EHR. SOS-Rx and NCL believe any definition must include rapid adoption of implementable, usable computerized prescribing technologies; work in various practice settings with existing IT infrastructures; encouragement rapid development and adoption of standards allowing choice of systems and common services; encourage creation and application of appropriate incentives and education; and preserve the patient/physician relationship and choice in delivery of health care. SOS-Rx will consider additional patient-focused criteria (e.g., support of safe care, use of nationally adopted technology standards, compliance with best practices, patient access to educational and reference materials, patient access to a complete medication regimen, enhanced communications, portability across systems, and maintenance of patient privacy and trust).

Ms. Rein asked NCHVS to acknowledge the critical nature of workflow as well as technology and data standards. She emphasized ensuring that patients could: instruct providers to transmit a prescription to their choice of pharmacies, review and update their medication list before any electronic prescription (e-prescription) transaction occurred, and self-report adverse drug reactions as defined by standards. Decision support rules must distinguish between information submitted by patients and providers.

Noting personal encounters undermined the public’s faith in the current health care system and people did not recognize how frequently medication errors affect patient health, Ms. Rein said SOS-Rx will collaborate with eHealth Initiative to identify patient touch points in the continuum of care affected by the prescribing process and chronicle e-prescribing’s benefits. Believing a tool that improved patients’ safety could educate and empower patients to act to improve their safety and compel providers to recognize benefits of e-prescribing at the patient level, NCL intends to integrate use of the personal medication record.

Discussion

Ms. Rein said she did not know of an available workflow standard but NCL and SOS-Rx would contribute to its development. Noting an absence of the consumer viewpoint in SDOs, Mr. Blair recognized the significance of NCL’s initiative and encouraged SOS-Rx to send representatives to SDOs to participate in these organizations. He noted concern from the patient and payer perspective about the potential abuse by PBMs or pharmaceutical companies of electronic displays of formulary information, and asked for suggestions for standardizing format communication and/or display of formularies to eliminate or minimize marketing or bias. Dr. Chess said there was massive promise, but current reality was motivated by dollars and it was naïve to think that the way physician’s cared for their patients would not be influenced. He suggested the responsibility was to create guidelines to guide the system in making this interface informative and not a barrier to care. Noting some ways were relatively simple, he said the underlying problem was making changes in the system without studying their impact on health care. For 17 years, health care companies made primary care physicians gatekeepers for controlling a patient’s specialist utilization; hardly any health care company still utilized physicians in that role, limiting patients’ ability to get care. Dr. Chess stressed the need for studies up front before implementing massive change. At the minimum, significant studies had to be done simultaneously so that, “down the line,” data existed so people knew what to do next.

Suggesting that formulary was already “a third party in the room” before e-prescribing, Dr. Warren asked Dr. Chess to explain the caution he wanted NCVHS to take in looking at standards. Observing that there were a dozen HMOs in his community, each with its own formulary, Dr. Chess cited a study indicating it was unusual for physicians to look for “a piece of paper” to find out what was on a patient’s formulary. Instead, Dr, Chess said he went ahead and prescribed what was in his patient’s best interest. He noted three ways patients were switched to alternative medication. Most were stable and changed health plans or their plan changed formulary. Pharmacist informed others of increased co-pays. Other times, economics were discussed while writing the prescription. Dr, Chess predicted compliance with formulary would sore from 40 percent into the mid-90s, markedly impacting patient care. He stressed that the issue was not standards but guidelines about what a PBM, government or health care company could put on the interface and whether it created barriers to physicians prescribing what was in their patient’s best interest.

Ms. Rein said NCL ultimately sought a Web-based tool for patients to access and update their medication record as a component of a broader health record. NCL currently focused on a paper-based system. Eventually, e-prescribing could incorporate elements for patient access through the media physicians used. But she cautioned that, unless patients could access that information through e-prescribing, clinicians could not have full information. Dr. Andy Barbash said a basic premise of the project to engage consumers in managing their medication list was the potential impact it would have on e-prescribing.

Dr. Chess clarified that he believed a way to gain without advertising or “going through many screens” the data for an intelligent, informed conversation with patients should be built into the standards. He welcomed details about cost sharing, sought a level of transparency and pharmacy plans that did not require preauthorization. He called for studies to determine formularies’ appropriateness for various categories of medicine. Ms. Rein said NCL will do consumer research to understand the workflow spectrum. Dr. Cohn observed that quality and economic issues affected health plans and PBMs and there might be an economic argument both should consider.

Asked if NCVHS should advocate a standard that permits prescriber access to the effectiveness, side effect, and patient cost information and lets the prescriber communicate to the pharmacy the rationale for a drug choice, Dr. Chess cited the value of a real data repository with head-to-head comparisons of medications. But he noted that research and comparative efficacy charts did not exist. Ms. Rein noted this seemed to be a lot of information to convey to a physician and patient; a medium conducive to understanding at both levels would be a challenge. Dr. Chess clarified that he favored decision support systems and algorithms that provided proper information based on proper studies. But he emphasized that he had to make decisions about the care of his patients that might call for taking risks the textbook did not consider the best channel.

Noting pharmacists and physicians on P&T Committees took their obligations seriously, Mr. Rothermich with Express Scripts disputed that formularies were driven by economics. Economics “broke ties.” He emphasized focusing on providing information at the point of care and informed decisions, not a referendum on cost management tools. Dr. Chess noted there were thousands of formularies and variability in their form. He acknowledged that formularies done intelligently might help the health care system contain costs, but pointed out that no studies looked at the whole continuum of care. Dr. Cohn noted, under MMA, formulary discussions were held on a separate track to determine the Part D formulary’s structure and categories. NCVHS was responsible for identifying the most useful ways to get formulary information to the clinician, not the formulary itself.

STATE BOARDS OF MEDICINE, Lisa Robin, Vice President of Leadership, Government Relations, and Policy, Federation of State Medical Boards

Ms. Robin discussed regulatory challenges to protecting the public that prescribing and dispensing medications via the Internet, created for state medical boards. In 1996, FSMB published a model act regulating the practice of medicine across state lines. It published in 2000 guidelines for Internet prescribing and, in 2002, guidelines for appropriate use of the Internet in medical practice. Both state that an appropriate relationship between the patient and physician must exist before a prescription is written and medication dispensed.

FSMB established the National Clearinghouse on Internet Prescribing in 2000 to collect and disseminate information on rogue Internet sites offering prescribing and dispensing services for prescription drugs based on an online questionnaire. The clearinghouse coordinates information between regulatory and enforcement entities and has supplied information for over 150 federal cases and over 300 cases on the state level. Some 39 state medical boards have acted against licensees; 26 adopted rules and policies; 14 states introduced legislation to clarify authority. State medical boards communicate about physicians licensed in more then one state and cooperative efforts have closed several Internet sites and caused physicians to cease affiliation with questionable operations.

FSMB supported development of federal legislation to protect patients ordering prescriptions over the Internet. Mrs. Robin noted H.R. 3880, the Internet Pharmacy Consumer Protection Act, and its companion bill S. 2464, currently before Congress, would provide significant protection for consumers. H.R. 3880 requires an Internet pharmacy to disclose the name and location of the pharmacy as well as the name and licensing information of the physician providing the medical consultation. Ms. Robin noted disclosure would not only be beneficial to patients but allow state medical boards to identify individuals and take disciplinary action. The bill authorizes nationwide injunctive powers to state attorney generals who otherwise could not enjoin the operations of an Internet pharmacy operating from another state. H.R. 3880 also addresses ambiguity with language, striking a reasonable balance requiring and defining an appropriate physician/patient relationship for the narrow purpose of regulating Internet pharmacies while recognizing, under other circumstances, the exclusive role of state medical boards in defining that relationship.

FSMB’s guidelines address physician use of electronic communications and the Internet in delivery of patient care. Treatment and consultation recommendations made online, including issuing a prescription via electronic means, will be held to the same standards as those in traditional settings. Treatment, including issuing a prescription based solely on an online questionnaire or consultation, does not constitute an acceptable standard of care. A documented patient evaluation (including history and physical evaluation) adequate to establish diagnosis and identify underlying conditions must be obtained prior to providing treatment, including issuing prescriptions

Discussion

Ms. Robin clarified that the basis of FSMB’c concern was appropriate licensure, interaction and relationship between a provider and prescriber licensed in the patient’s jurisdiction. Disciplinary actions against physicians were public information. FSMB supported mechanisms that facilitated legitimate telemedicine practice; the difference between Internet pharmacies and telemedicine was that patient records were available in a telemedicine consultation. Ms. Robin said unique identifiers would help medical boards and other regulators identify individuals writing prescriptions without patient information. Asked if FSMB’s objections would go away with NHII which made this information accessible, she said FSMB’s only concern was that patient information was available and evaluated before treatment. FSMB had not defined an appropriate physician/ patient relationship but Ms. Robin noted it was an offer and agreement for treatment and according to FSMB policies did not need to be in person. Eddie Allen, FSMB’s Washington representative, pointed out that prosecutors, questioning that they could prevail in court without a hard-and-fast definition of the physician/patient relationship, were reluctant to proceed.

Asked about guidance to states considering e-signatures, Ms. Robin noted patients had to know where their prescribers were licensed so they could file a complaint if necessary. She said a set of criteria applicable for either an Internet pharmacy or e-prescribing was that the prescriber was identified, licensed, and a process authenticated that individual reviewed specific information for that prescription. FSMB’s position was that, when done as part of a physician’s normal office practice, e-prescribing did not generate additional conduct requirements beyond a written prescription. Ms. Robin emphasized that e-prescribing should be held to the same standards as other areas of practice.

STATE BOARDS OF PHARMACY

• Carmen Catizone, MS, RPh, DPh, Executive Director and Secretary, National Association of Boards of Pharmacy

Dr. Catizone said the model state pharmacy practice act and regulations the National Association of Boards of Pharmacy (NABP) used working with electronic transmission defined key electronic transmission terms, digital and e-signatures, and if state computer systems require security systems for access and authenticating prescriber, pharmacist and patient information. Ever since facsimile transmissions were first used in 1996, State Boards of Pharmacy have dealt with issues of access to the prescription order, standards for the prescription and the quality of care, defining entities involved in accessing records, and decisions about medication related to the practice of pharmacy and licensure.

NABP deferred the technical standard portion of electronic transmission to SDOs but worked closely to ensure standards recognized and did not conflict with state regulation or security requirements. NABP understood the need for preemption of state pharmacy acts and regulations to avoid disparity, provide uniformity, and ease interstate transmission and conduct of business. But Dr. Catizone emphasized that safeguards in state laws should not be preempted by federal standards or legislation. He noted NABP was involved in the Internet, had an accreditation program for Internet pharmacies, looked at transmission of data and prescriptions, notified states of disciplined pharmacies and pharmacists, and collected consumer complaints.

STATE BOARDS OF PHARMACY

• Eleni Anagnostiadis, RPh, Patient Safety Senior Manager, National Association of Boards of Pharmacy

Dr. Anagnostiadis noted the increase in regulatory activity regarding electronic transmission of prescriptions was associated with anticipated changes in the Medicare requirements. NABP recently conducted a survey of state boards of pharmacy determining which states allow for e-prescribing and identifying challenges and barriers states face developing regulations and implementing. Nearly every state allowed for some form of electronic transmission of prescriptions, including facsimiles. Major challenges and barriers had to do with security and technology. Security issues included a lack of uniformity of security and safeguards used by companies, security of the prescriptions, verifying authenticity, e-versus digital signatures, third-party intervention, forgery, and incorporating biometrics ensuring irrefutability. Other barriers were that regulations could not be changed often enough to keep up with evolving technology and that the government process for approving regulations was lengthy and an impediment.

She compared state regulations regarding e-prescribing, prefacing her report by noting it was often like comparing “apples and oranges.” E-signature and/or other secure methods of validation were high priorities for many states and often regulated. Nearly half the states required some form of electronic signature and/or other secure method of validation. One of the few states requiring digital signatures will address the cost of available technology by moving to include e-signatures. A third of the states do not address the issue of electronic transmission or signature.

NABP defined e-and digital signatures in their model rules and regulations and recommended to state boards that either accompany e-prescriptions. Dr. Anagnostiadis urged NCVHS to talk with DEA about what signature would be required to transmit controlled substances. Similarities about what must be included on the electronic order included: the transmitter’s phone number, date/time of transmission, identity of both the pharmacy intended to receive the transmission and the authorizing agent. Another commonality was the pharmacist’s ability to exercise professional judgment regarding the prescription’s authenticity and validity.

Dr. Anagnostiadis highlighted five core principles or elements NABP believed should be incorporated into a standard: ensuring against unauthorized access, authenticity and security of prescriptions, HIPAA privacy requirements and confidentiality laws, patient choice regarding pharmacy, and sustaining prescriber/pharmacist collaboration.

Discussion

Dr. Catizone emphasized that the five principles were areas that should not be preempted. NABP and many state boards contended there should no intervening third parties that might alter the prescription. Noting some states did not even allow passwords in computer systems for processing prescriptions, he asked NCVHS to consider security provisions for accessing systems used by prescribers and pharmacies. He noted NABP worked with the states to ensure state laws complemented HIPAA and provided assurances beyond the federal act.

Both testifiers emphasized that states were “on hold” awaiting federal definitions of e- and digital signatures acceptable for controlled substances. NABP’s definition was that an e-signature was an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted with the intent to sign it. A digital signature was an electronic signature based upon cryptographic methods of originator authentication and computed using a set of rules and parameters so the identity of the signer and integrity of the data was verifiable. E-signatures were broader. Digital signatures were e-signatures; not all e-signatures were digital. Both enabled identification of the signer, authentication and non-repudiation. NABP’s model act defined person as any entity (individual, corporation or pharmacy), established that pharmacy practice did not manipulate the prescription, and the requirement for repudiation. Asked about regulatory requirements for written retention, Dr. Anagnostiadis noted many put in place before the technology evolved would have to be changed.

Dr. Catizone noted the basis for taking action against pharmacies and pharmacists: a valid prescription had not been the basis for dispensing, dispensing medication to patients without a prescription, or dispensing unapproved products (i.e., imported from Canada). State medical boards decided online questionnaires and cyberspace consultations did not constitute an acceptable standard of medical practice and used that as a basis for taking action.

Dr. Anagnostiadis said several states would have difficulty implementing e-prescribing but NABP would work with the boards to overcome the challenges. Dr. Catizone said most of what was required on the prescription was fairly uniform across the states and mirrored federal requirements. Variations beyond core requirements were more numerous and could be problematic if a standard format for e-prescribing did not meet some state requirements.

Noting some laws and regulations would make adoption of standards for e-prescribing more burdensome in some states and there might be a backlash, Dr. Catizone suggested a preemption that retained good components of state laws and collaborating to eliminate more restrictive requirements. He noted other issues of privacy and confidentiality were already addressed in the state practice acts. Whatever safeguards e-prescribing asked for or put in place only had to complement existing state laws. He emphasized ensuring that anything going did not inadvertently decrease privacy safeguards currently intact so much that states were not comfortable with lessoning restrictions. Dr. Anagnostiadis submitted a copy of the model rules, noting the survey results and a search regarding the prescription drug order would be forthcoming.

PAYER PERSPECTIVE

• Joseph Raduazzo, M.D., Medical Director, Tufts Health Plan

Dr. Raduazzo discussed a pilot THP and others undertook to demonstrate that e-prescribing could improve the safety and efficiency of the prescribing process. He emphasized that physicians needed help tracking the17,000 brand and generic medications on the market. Some 1,500 medications or new indications were released in the last three years. The average physician dealt with 16 insurance plans, each with multiple benefit designs, and at least 16 formularies. E-prescribing was an effective tool for getting that information to physicians when prescriptions were written. Citing recent estimates of the number of deaths from medication errors and the American Society of Health Plan Pharmacists survey finding 61 percent of patients concerned about getting the wrong medication, Dr. Raduazzo noted a significant credibility issue.

The pilot provided e-prescribing software and hardware to 200 providers. Individual hand-held computers were connected through a wireless network to a server in doctors’ offices updated each night through the Internet. Information on formulary choices, prior authorization needs, preferred drugs, some medication drug reference, and patient history was provided. Patient history allowed physicians Prescribed or adjudicated patient history allowed prescribing physicians to review the drugs the patient took and avoid potential drug/drug interactions, but Dr. Raduazzo noted most physicians’ offices still could not communicate well. Physicians sent electronic faxes directly to the pharmacy (at that time, the Massachusetts board of pharmacy did not permit electronic signature).

Patient eligibility, benefit design including prior authorization requirements, formulary information, medication history, drug/drug interactions, physician alerts about discontinued drugs and formulary changes, and reporting functionality allowing a physician to know if members’ prescriptions were filled were added. Allergy screenings will be added in August. Using the technology reduced prescription rejections, decreased errors, and identified non-compliance. Dr. Raduazzo noted a savings at one hour-per-physician/pharmacist-per-day.

A lesson learned from the pilot was simplicity. Implementing e-prescribing was labor intensive, required training, and had to be integrated with the existing PMS. Workflow changes took time and physicians, their offices already working to capacity, were resistant to change unless it would save time. He emphasized that it was important that physicians understood the standards were compliant with HIPAA legislation.

Dr. Raduazzo noted the privacy act in Massachusetts did not let physicians see any drug history on substance abuse, mental health, or HIV without expressed patient approval separate from the HIPAA approval. Accordingly, THP limited the patient history seen in their e-prescribing devices. Physicians’ responded negatively, feeling this compromised their ability to safely prescribe. He noted most physicians had no IT budget or money to invest in e-prescribing. Focus groups felt they should be reimbursed for using an e-prescribing device. Health plans were considering but had not moved in the direction of reimbursement.

He advised NCVHS to stick to standards put forth in the MMA, pointing out other suggested standards (e.g., laboratory data and drug interaction screening) required merging of databases that in most practices currently could not merge. He urged NCVHS to ensure that the standards were straightforward enough that they could be applied evenly. He advocated a streamlined process for changing standards so they could grow as technology expanded. America’s Health Insurance Plan’s, a national trade organization, recommended formulary benefit information be available at the point of care. Dr. Raduazzo urged that a pilot be undertaken with these standards. Noting the move toward the interoperable medical record, he stressed the importance of allowing the ability to carry a medical record on a thumb drive or smart card.

PAYER PERSPECTIVE

• Charles Kennedy, M.D., Wellpoint

Dr. Kennedy described how WHN’s strategy in e-commerce moved from administrative transactions and “front office functionality” to enabling processing of claims via a Web-based link. WHN was moving to expand this capability to more clinically oriented administrative functions (e.g., ER notifications) and clinical support (i.e., e-prescribing and outcomes research services)

Deciding an alternative approach to trying to control soaring medical costs was required, WHN focused on getting infrastructure out in the delivery system. WHN felt pilot successes justified a $42 million dollar investment deploying e-prescribing to 19,000 physicians within a five-state network representing 75 percent of members’ office visits. WHN offered physicians wireless connectivity via the Internet to an ASP vendor hooked up to WHN’s PBM and an interface to the PMS within the physician’s practice. Only 15 percent of the physicians chose the handheld e-prescribing unit with software loaded on it for e-prescribing capabilities, a wireless hub, and one-year subscription to an e-prescribing service. Those that did received decision support at the point of care when making prescribing decisions. Prescriptions were faxed to the pharmacy of choice. More than 80 percent of the physicans chose an alternative paperwork-reduction package: a desktop computer that could access WHN’s Web site.

WHN partnered with Microsoft to provide a level of sophistication and support and ease physicians’ concerned about being stuck without a solution when smaller companies “bellied up.” Dr. Kennedy noted acting on this scale required vendors who could delivery; only a few met WHN’s financial-wherewithal-and-level-of-technical-sophistication criteria. WHN pushed their vendors to ensure most deployments could be done remotely. Vendors were required to write custom interfaces to support the targeted volume for the physician delivery system, slowing down the pilot and flagging the need for standards.

Dr. Kennedy said data indicated a one percent increase in generic utilization equaled a half percent decrease in total drug utilization costs. WHN believed the technical, business, and clinical case was there and concrete, low-level measures of success (e.g., formulary compliance, generic utilization) would show added value and appropriate ROI on investment. WHN will track measures around quality of care and look at standard utilization metrics, admissions to the ER due to adverse drug events, and hospitalizations. Dr. Kennedy said WHN considered e-prescribing a foundation upon which to build additional value for members and was initiating outcomes research. Using their e-prescribing infrastructure and linking lab data from vendors to administrative claim data, WHN has begun building a comprehensive view of their network’s clinical practices that they will feed back to physicians.

Dr. Kennedy said WHN had anticipated that competitive parody would force other health plans to launch similar efforts and cooperated with competitors to get additional physicians and health plan data on board.

Stating office managers neither understood nor valued e-prescribing, Dr. Kennedy stressed that successful deployment depended on directly reaching physicians and getting their buy off. Physicians were concerned about the ongoing price and apprehensive that a health plan providing this technology would gain financial concessions. They most often asked how big their commitment had to be, how it would impact office workflow, and how they could be sure information was correct and alerts clinically valid.

Dr. Kennedy said deployment of a mobile solution was complicated, time consuming, and interrupted patient visits and revenue. PDAs were not robust enough for doctors used to the geographic independence of cell phones and seeking to prescribe in an 802.11 environment.

Dr. Kennedy emphasized three messages. Health plans had a central role in deployment of e-prescribing and EHRs. Barriers to both were as much business model and business-oriented as technical or standards based. And meaningful progress in deploying either solution required a respect for and focus on payment methodologies, advances in biotech and clinical research, leverage and use of data captured through this infrastructure, feeding input back to physicians, and other business processes/ structures enable getting value out of the e-prescribing investment.

Discussion

Dr. Kennedy explained that the desktops in the alternative paperwork-reduction package did not have e-prescribing capability. Basic Internet access was provided along with integration and interoperability with NHI. WHN’s vendors supported an HL7 interface and worked well with those PMSs. But most physicians in the network had five-or-less doctors and older PMSs not designed for such interfaces. Half the practices could not interface easily. He emphasized that getting clinical and administrative interoperability was critical. WHN looked at HL7 standards for laboratory, patient demographic, ICD and PCT data. When they had either ANSI or HL7 standards to work with they could “talk” to the PMS. The NCPDP standard was not involved.

Dr. Raduazzo noted RxHub served as an enormous “junction box” through which health plans, pharmacies, physicians and PBMs could transmit electronic data in a safe secure environment. In 2002, THP’s pilot relied upon directly connecting with a PBM. THP’s e-prescribing functionality could do so with their health plan and Blue Cross/Blue Shield of Massachusetts. Massachusetts had no single conduit and no other plan or Medicaid could send information there in that way. Dr. Raduazzo noted that functionality would be available for interactive formulary information and eligibility information on virtually any patient, once RxHub functioned at the level of every physician. Dr. Kennedy said WHN had a custom direct interface with Zicks and Allscripts but their contract required a link to RxHub so other physicians could have that functionality as additional PBMs came on board. Terri Burn clarified that RxHub had used these standards for three years, was in production, and open to connecting to any payer.

Dr. Kennedy reported under five percent of the offices in WHN’s network had EHRs. If a set of e-prescribing standards came out, WHN will encourage their vendors to go to the standards.

Asked why THP recommended sticking with what was in the original MMA document, Dr. Raduazzo said it was a reasonable expectation of the connectivity most vendors currently could deliver. Dr. Kennedy said WHN insulated themselves from many of these issues by being somewhat “standards agnostic,” but requiring vendors to be consistent with nationally adopted standards.

Dr. Kennedy said WellPoint had no formal plan for incentives for adoption and considered whether quality bonuses could continue to be paid without e-prescribing and EHRs. WHN saw pay-for-performance opportunities for select physicians to diversify their revenue stream while participating in outcomes and clinical research. He noted WHN was committed to helping participating physicians with their financial and technical risk. Dr. Raduazzo noted THP created a differential in payment for physicians who implemented e-prescribing. THP supported creating a financial business case. Tiering a network made a big difference, and many tiered-network products were scaled based on economics and quality/efficiency. THP’s rationale was to compensate physicians for implementing and using processing.

Asked if Microsoft’s vulnerability to viruses was a concern, Dr. Raduazzo said THP strove to be operating-system agnostic and used a product compatible with multiple systems. Security topped WHN’s list; all data was stored centrally, not on a device. WHN sought platform independence; Dr. Kennedy noted however that Microsoft had resources to provide patches.

WHN’s business model for e-prescribing was subscriber-based. WHN paid for the infrastructure to “seed” the market, a one-year subscription to the ASP vendor providing the service, and pushed their vendors for a preferential fee that the physician ultimately paid. Pharmacy currently had no role to play because prescriptions were e-faxed. WHN believed pharmacy connectivity had significant worth, but considered quality of care and the commercial/relationship value proposition a relatively more important value add-on. Dr. Kennedy said national standards improved the business case by reducing deployment time, improving ease of deployment, and freeing vendors from locking into proprietary solutions.

PHARMACIST PERSPECTIVE

• Kevin Marvin, RPh, Chair, American Society of Health System Pharmacists

Dr. Marvin noted pharmacists’ responsibilities included complying with FDA, DEA, state boards of pharmacy, Joint Commission of Accreditation of Health Care Organization (JCAHO), pharmacy benefit plans and state practice standards requirements. Citing studies indicating the percentages of errors in medication orders and that 177 billion dollars was spent annually on outpatient medication-related problems, he presented ASHSP’s views on developing e-prescribing standards. ASHSP supports standards developed in an iterative process with appropriate measures to support continuous process improvements and not hinder the ability to safely and efficiently meet patient’s medication therapy needs. Standards should be developed in consideration of the need to evolve existing systems to meet them.

Dr. Marvin echoed the need to support universal identifiers of patients as well as prescribers. Standardized methods were needed to verify prescriber’s identifiers in order to meet DEA and state board of pharmacy requirements. Including other patient information and standardizing communications also supported efficient use of dosing and allergy checking. Minimally, allergy coding should be standardized and stored with the medication profile.

ASHSP supported: continued expansion of HL7 and NCPDP script messaging standards simplifying transmission of medication order and prescription information, standardizing use of the generic medication name and continued development of RxNorm standards focused on generic naming structure as well as dosage forms, unit of measure and standards allowing automated conversion for dose checking. Dr. Marvin noted modifiers often were not retained in a standardized way to support automated checking of allergies and pharmacy in selecting correct items. Instructions or SIGs also had potential for standardization. He emphasized that e-prescribing standards had to be structured to support medication process workflow and handoff, and cautioned there would continue to be an error-prone transcription process unless e-prescribing standards considered translation of medication entity to product detail. Dr. Marvin said standards had to provide a hierarchical framework for medication coding from the drug entity to the product level (NDC). Standards were needed to define the source and owners of each data element in an order or prescription. Systems had to support communication of decision rationale downstream into the medication use process. Passing medication/medical benefit plan information to the pharmacy would support faster processing of the prescription by the pharmacy. The patient’s HIPAA release for the pharmacy should be received prior to during this handoff. The e-prescription system should also support upstream communication in the medication use process.

E-prescribing standards also had to support patient empowerment. Patients needed to be able to select the pharmacy, payment method, and influence proper selection or product selection within the prescriber’s intent. Patients also needed the ability to review the consolidated medication history information and verify that the medication received matched the medication ordered. Methodologies were needed to assess the system’s safety and efficiency and provide evidence supporting continuous improvement of the processes and standards.

JCAHO and state boards of pharmacy require pharmacists to review medication orders prior to dispensing it to the patient except in emergencies. Pharmacists need complete access to a patient’s medication profile, allergy information, problems/diagnosis lists, height and weight information, other applicable laboratory results and clinical data to support order verification. Dr. Marvin noted electronic rule-based clinical checks were not complete and did not support other pharmacist functions including direct monitoring of patients, education of patients, local and regional practice differences, and identification of programming/system set up errors.

Discussion

Dr. Marvin explained that the pharmacy TC of HL7 developed and identified the named fields and identified field links but many components of the HL7 standards lacked data element content standardization. Sandra Mitchell from Johns Hopkins University noted that HL7 standard’s short list in dose routes or forms did not suffice for clinical practice in a hospital. Recalling many messages, especially NCPDP script, were in text format and noting that (though pragmatism/ease-of-use might dictate otherwise) if everything would be specific and measurable if it was codified, Mr. Blair asked about others’ perspectives. Lynn Gilbertson from NCPDP said everyone agreed codifying SIG would be an asset but prescriber, dispenser and other user needs had to be balanced. Only one- or two-offs (i.e., outcomes/research), not direct users, might see immediate benefits. Scott Robertson, co-chair, HL7 Medication Information SIG, noted most automated dose checking came down to maximum daily doses/dose vs. weight and could be done without complete codification. Dosage form implied route of administration, but was not always necessary.

Dr. Steindel said they heard that mapping NCPDP script to HL7 and developing SIG codes tomorrow would be too late.; they had to find the paths and move now. Responding to numerous comments about standards for workflow, Dr. Marvin noted a need to balance between being driven by technology in ways no one wanted to go and changing practices to be more efficient with new technology. Participants noted confusion about the patient’s HIPAA release for pharmacy and between NOPP and authorization. Members observed that communicating rationale for the prescription and warning override added a significant degree of complication to the physician’s workflow but eliminated the pharmacist’s follow-up call.

PHYSICIAN PERSPECTIVE

• Clement McDonald, M.D., Regenstrief Institute

Dr. McDonald said he had few doubts about e-prescribing’s benefits. Call backs to physicians resolving problems with the prescription averaged $25 dollars. Patients would benefit from a smoother process and a prescription already filled. Reducing the refill burden, providing medication history, and a system that quickly traversed the jungle of formularies constraining prescribing would be “nirvana.”’ Yet physician’s offices were “slow on the uptake.” Hardly any doctors he knew used e-prescribing. Dr. McDonald considered issues from their point of view and how e-prescribing might be made more attractive, saying he hoped NCVHS could suggest incentives and policies to eliminate those barriers.

He discussed entities that had to be identified for e-prescribing and issues with each. The patient’s name used by many office practices was subject to misspellings and name variants; a combined identifier was better. Standalone e-prescription systems did not readily handle the amount of data pharmacies needed to identify patients. Dr. McDonald encouraged focusing on a swipe card, universal person identifier, or other mechanism that permitted automatic, solid and easy linking.

Dr. McDonald noted everyone waited for FDA’s NDC but DEA (although FDA parameters might view it illegal) or the doctor’s license number worked.

He cautioned that medications could be identified at different levels of granularity. NDC was most granular, but had problems. Prescribers would not want to identify medication at the complexity of the NDC level. He noted most systems provided a way at two levels between the provider and NDC code: one had the generic drug and route; the other added the dose.

NCPDP required NDC and possibly another identifier supplied by a drug knowledge base (DKB) vendor that had to be matched. Dr. McDonald said the medication instruction was not a problem although the current standard permitted it to only be sent as text, even though the pharmacy system might enter from a coded list.

Observing that the nightmarishness of dealing with formulary constraints became easy when connected to the office management system, Dr. McDonald predicted this would be a big motivator for physicians.

Dr. McDonald suggested being able to deliver anywhere in a chain or to a clearinghouse.

He said the biggest benefits for physicians were having formulary built into the prescribing process and the medication profile based on all prescriptions filled for a patient. Currently, much of the formulary came from RxHub, but none had it all and Medicaid was not a part of it. Medicaid of Florida provided for its Medicaid, but no one else was on that system. He noted that, with a complete medication profile, physicians could intervene on redundant prescriptions and patient non-compliance. Dr. McDonald recommended providing medication profiles from pharmacies in a single unified view. Refill information could be pulled from a central source. He emphasized that the infrastructure had to be innovative and stimulate things. Dr. McDonald noted the desirability of a profile, a more sophisticated computing process requiring generic codes. Other benefits were the ability to explicitly discontinue a drug and more refill streamlining, although he noted fax was “not bad.”

Discussion

Recalling Dr. McDonald said “the world would be simpler” if a generic name and route identified drugs, participants discussed RxNorm. Dr. McDonald advised against going to NDC’s level of detail; noting that was supplied by RxNorm and hierarchical codes in DKB. He recommended not specifying pill size or concentration. Asked if, as a physician, he wanted OTC drugs and herbals, Dr. McDonald suggested “walking before you run,” noting those would be “nice, but more difficult.”

Dr. McDonald remarked that the law did not state prescribers had to enter the prescriptions and he cautioned that requiring that could shut down offices. Noting tension between PBMs and prescribers as to preauthorization’s threshold of difficulty, Mr. Blair asked for guidance. Dr. McDonald said he worried about “so-called preauthorization” which, however one had to do it, was a delay and tantamount to “not doing it:” Inducement was imposed, though he acknowledged he was not certain this was wrong because the cost of drugs was so high and climbing. Mr. Reynolds noted he heard actual prior approval in drug situations was less than two percent. Dr. McDonald said it was rare in his environment outside of Medicaid.

Tony Schueth from Point of Care Partner, said five companies aggregated formularies. Four (RxHub, CAQH, Medi Media and Proxymed) supply IT (e.g., EHR) vendors. Brian Danberger, President, Medi Media Information Technology, said the issue was identifying which plan went with a patient, not aggregation. Mr. Schueth noted venders testified at the May hearings about the challenge of getting patient demographic data into e-prescribing or even EHR. No PMS was dominant and many did not know HL7 or X12.

Noting not all formulary information came electronically, Dr. Cohn asked if Web sites would be sufficient. Dr. McDonald said he would not want to go to Web sites, but Web servers applications could probe would be workable.

Asked if HIPAA privacy regulations had been an impediment beyond the fragmented PMS, Mr. Schueth said technology company clients said it was not.

Ms. Gilbertson noted that, if the Medicare Part D environment required more prior authorization, they would have to consider that for the program to succeed.

OPEN MICROPHONE

Phil Rothermich with Express Scripts noted prior authorization managed exceptions. Plans and PBMs knew it was disruptive and used prior authorization as an exception process when there was clinical reason to cover an expensive drug in a limited circumstance. He cautioned that an unintended consequence of removing barriers could be that health plans dropped coverage. He suggested step therapy as an option. Tony Housen reported CMS published proposed rules on prescription drugs and welcomed comment. He clarified the prescription drug plan (PDP) was not required to aggregate a patients’ medications. Dr. Sullivan, past president of the Massachusetts Medical Society, noted they first aggregated formularies ten years ago. Health plans had neither wanted to get together nor not trusted the medical society as mediator. The tiering process began; plans again were unhappy with aggregation and formularies were complex. He suggested the continuity of care record (CCR) as at least a temporary solution. Cynthia Howard from CMS shared experiences as a caregiver and described how the personal health record she made for her mother helped doctors.

Tom Bizzaro with First DataBank clarified that NCPDP allowed but did not require NDC. Ms. Trudel clarified that the NCPDP Telecommunications format would contain claim information that went to PDP and then Medicare for risk adjustment. Mr. Bizzaro expressed confidence that conversion vendors would address PMS interface issues. Participants noted how many e-prescribing companies folded and the market fragmented as newcomers emerged. Noting conversion to one solution was complicated and slow, Mr. Schueth suggested having all PMS on the same HL7 version.

Dr. Steindel noted they heard both the need for an e-prescribing standard sending to a designated pharmacy and that this imposed workflow issues. He emphasized clarifying in their letter to the Secretary whether the Internet could be used for e-prescribing. Mr. Reynolds expressed concern about recommending the patient identifier when most the health care industry spent millions of dollars de-identifying individuals. Dr. Cohn pointed out that CMS used an identifier (HIC numbers) to uniquely identify Part D Medicare members. He noted the Subcommittee was asked at the last NHII Workgroup meeting to investigate the issue of uniquely identifying patients in the health care system with pointers and other approaches (e.g., master patient indexes [MPI]).

-DAY TWO-

Dr. Cohn acknowledged a letter from Senator Grassley clarifying legislative language and intent of the e-prescribing section of MMA and requesting an update on the Subcommittee’s work developing their recommendations. Dr. Cohn said the Subcommittee will compose a response next week offering to update the senator. Mr. Blair noted that the NCVHS Subcommittee on Standards & Security began evaluating e-prescribing standards early in 2004 and that this activity will continue into 2005. This work effort is in response to MMA’s charge to NCVHS to evaluate, select and recommend e-prescribing standards. Members supplemented the law’s directions in some cases. Version nine of the work plan was posted on the NCVHS Web site.

AST OVERVIEW OF CONTINUITY OF CARE RECORD INITIATIVE, Bill Braithwaite, M.D., PhD, ASTM E31.28 Continuity of Care Record Steering Committee

Dr. Braithwaite presented the CCR steering committee’s recommendations asking NCVHS to ensure standards for e-prescribing allow integration of existing and future EHR systems as sources of medical history; ensure data standards for interoperability are ANSI-accredited and consensus-based; look to CCR data element standards to meet this need because of their consistency of purpose; and hold CCR and HL7 to issuing well-timed harmonized versions.

Dr. Braithwaite said demographics, problem list, allergies, side effects, lab results and other elements of the patient’s medical record had to be fed into an effective e-prescribing system along with other prescribed drugs. Clinicians could not be expected to reenter data; the only choices were to integrate e-prescribing functions into every EHR system or build e-prescribing and EO charge systems using interoperable standards so whichever was implemented next interfaced with the other without disrupting clinical data and work flows.

He noted prescribing clinicians were the source of the CCR standard which was primary developed to form an electronic summary of personal health information clinicians could send with referred patients, promoting continuity, quality and safety of care. Many clinical associations and vendors supported CCR. Some of the enthusiasm for CCR was because it gave clinicians a way to convey what they needed in their clinical practice to the standard-setting process.

CCR was designed for all clinical care referrals/transfers, handled structured and unstructured information, and was technology and vendor neutral. More granular than other standards, CCR had been mapped to SureScripts Proxymed, NCPDP and RxHub formats and contained essential data elements for prescribing using those mechanisms. Comprised of eight sections of mandated core elements, CCR was offered on XML platform and supported both paper and electronic (browser version, HL7 message, secure email, PDF) media. HL7 SDO and CCR steering groups collaborated to harmonize CCR standard data elements with HL7 reference information, vocabulary models and the message standard. Over 30 vendors at the February HIMS and May TEPA conferences demonstrated implementation.

Discussion

Although the Massachusetts Medical Society introduced CCR, adapting a Department of Public Health mandated patient care referral paper form and several hospitals subsequently developed their own electronic versions, Dr. Sullivan said ASTM was not widely used in the state and not used at all electronically.

Asked how CCR-type data could be entered if the e-prescribing system went in first and there was no EHR system to feed it, Dr. Braithwaite explained the e-prescribing system’s USB port could accept CCR off a patient’s thumb drive. So long as systems were interoperable, CCR could be used without loss of implementation time or productivity.

Dr. Fitzmaurice commented that CCR seemed to have a good grassroots origin. He noted HHS purchased five-year rights to SNOMED for $32 million and was anxious to gain value from the investment. Pointing out that CCR had no vocabulary behind it, but common data elements might be mapped, he asked about harmonizing UMLS and SNOMED vocabularies. Dr. Braithwaite said, at some point, CCR had to “come down on the side of” particular standardized clinical vocabularies in order to implement e-prescribing and other systems providing clinical data and decision support. HL7 message standards allowed SNOMED or any other encoded mechanism; expression was not restricted in building a CCR.

Dr. Zuckerman noted a reason CCR was not in widespread use was that implementation guides still had to be finalized. Links to vocabularies (e.g., SNOMED, LOINK, Rx Norm) were being considered. CCR was structured to be flexible and accommodate multiple coding systems. Unlike an EHR system, CCR was a comprehensive patient summary. Its medication lists were meant to be comprehensive, including OTC and other medications. Dr. Sullivan noted the standard was developed in two years. Balloting on elements was approved in April. Implementation guides, reflecting input from vendor trials and the need for codes and security, went to ballot September 1.

Dr. Sullivan emphasized that newer e-prescribing tools (even standalones) were built, at a minimum, to ensure connectivity to pharmacy and PBMs. E-prescribing stand alones “married” to CCRs. Inputting PMS information into the e-prescribing system using a CCR and connection to the EHR would be a “real boon.” Dr. Sullivan noted connectivity to CCR and EHR was a journey. Coded instruction and vocabularies would be favored, but full potential of clinical decision support would not be realized until CCR had more structure.

Dr. Braithwaite and Dr. Sullivan agreed CCR would not reach full potential as a standard until it was harmonized with HL7. Many vendors, not needing HL7, strove to put something functional on the market. Some were already enhancing CCR’s function, knowing they would have to modify their systems to comply with the final standard. Asked for assurance that vendors implementing their own vision would not become another dead end, Dr. Sullivan said vendors could only increase their market share by incorporating a seamless exchange. Dr. Sullivan pointed out another focus of CCR was transferring data to patients with their personal health records. Dr. Warren, co-chair of HL7 Patient Care, noted a message on the August ballot for a care provision in HL7 version 3 would message everything in the CCR.

Dr. Braithwaite explained that the steering committee was looking at a standard conduit. The balloted standard was not a protocol but a defined list of critical data elements to move between clinical environments. Harmonization with HL7 lent format for messaging. Noting strong comments about e-prescribing not working without additional medical history, Mr. Reynolds asked how this would work without EHR. Dr. Sullivan said it already worked, but was painful and expensive. Dr. Braithwaite advised doing e-prescribing first, if necessary; but ensuring compatibility with future EHR/CCR systems.

Dr. Sullivan predicted high-volume prescribers would look at e-prescribing closely. Largely because of refills, ROI for them was easier to demonstrate early. Dr. Zuckerman noted many scripts were written by specialists and in hospitals and emergency rooms. CCR enabled writing new prescriptions drawing upon accurate data from others. Physicians could edit what was relevant for the next provider, including other providers’ comments.

Dr. Sullivan said he had not seen any studies relative to medication errors and high- or low-volume prescribers. Asked if wrong medications were given because low-volume prescribers did not take time to check, Dr. Sullivan noted primary care practitioners were professionally obligated to know about other medications. Participants suggested high-volume prescribers might make more mistakes because they treated chronically ill patients on many medications.

PBM PERSPECTIVE

• Phil Rothermich, Vice President, Business Development, Express Scripts

Dr. Rothermich pointed out that this panel reflected a history of collaborating with cross-functional groups to use e-prescribing to solve issues with standardizing transactions and connecting to point-of-care vendors. Testifiers broke down the prescribing process based on their experience with component parts, identifying standards developed in collaboration with RxHub and by other organizations. Dr. Rothermich emphasized most currently leveraged standards were accepted industry-wide. Patient identification (ID) was done without assigning IDs. Eligibility and drug history transactions were handled and formulary information was provided at point-of-care.

Dr. Rothermich defined MPI as a central database and mechanism to aggregate demographic information in order to uniquely and efficiently ID a patient. Eligibility simply meant a patient had a payer or PBM benefit. Formulary at a plan level was one or several lists of drugs physicians chose from; benefit information influenced some key decisions. Formularies could have two or three tiers and benefit rules changed the landscape. A drug could be on formulary, but not covered, resulting in 100 percent co-pays. Medication histories currently were claim histories pharmacies sent to the payer and not complete. Pharmacies and physicians had pieces of the history. Patients moved about, paid cash and bought OTC. Point-of-care or technology vendors were software companies providing e-prescribing solutions. A router was any entity (RxHub, SureScripts) serving as a central hub forwarding transactions.

Dr. Rothermich noted RxHub developed standards through industry collaboration involving pharmacies, point-of-care players, PBMs and other payers in the e-prescribing process. Designed to leverage work already done, NCPDP, HL7 and X12 standards were utilized.

Express Script considered implementation an opportunity to give full information to physicians to make informed clinical and economic choices for patients. To enable adoption, Dr. Rothermich emphasized standards had to address work flow, how long the transaction took, and how it could be delivered most effectively and efficiently.

Dr. Rothermich stressed standardizing transmission standards for a formulary without controlling the formulary process or how industry determined formularies. He noted RxHub enabled standardizing transmission without sharing competitive information. Express Scripts supported standards from multiple SDOs and translations. He suggested NCVHS recognize all types of pharmacies, adopt what NCPDP needed, and work with them.

While not suggesting mandating RxHub, Express Scripts supported a multi-payer solution and saw RxHub standards as a mechanism answering many issues. Express Scripts connected through RxHub to technology vendors free to connect to others and choosing to do so uniformly. By leveraging standards, connections could be made in numerous ways through RxHub or other mechanisms. Emphasized that any solution adopted for Medicare also created standards for e-prescribing, Dr. Rothermich urged NCVHS to consider different components the commercial market needed. He noted four steps to the prescribing process: preloads, the actual prescribing process, fulfillment, and claims processing.

PBM PERSPECTIVE

• Terri Swanson, Chief Information Officer, Cigna Pharmacy Management

Ms. Swanson explained pre-loads: (1) enabled faster, more efficient decision support by collecting information prior to the physician’s need to access it; and (2) seeded routers with information so real-time transactions moved appropriately through the prescribing process. Basic demographic data extracted from PBM was loaded in the router, making MPI a multi-payer data source. The router linked members and payers. Another pre-load delivered formulary and benefit information from the payer or PBM to the point of care application. Formulary data was at the plan level. Each payer might have several formularies. Benefit information was granular and at the group level. Those pre-loads set up linkage to detailed benefit design at the member level. Formulary and group benefit data was combined with other drug reference data (e.g., First Databank, Medi Span).

Other pre-loads extracted identifying information from pharmacies and identification information from prescribers. This information was shared using an NCPDP based message format. Ideally, the point of care application monitored the physician’s appointment schedule, extracting and formatting patient demographic data into an eligibility request sent to the router. The router matched the patient and payers that could respond to the X12 270 eligibility request. Information on the eligibility response linked the member to benefits and formulary. Using information on the eligibility request, the point-of-care application had previously sent an NCPDP-based or HL7 message requesting the patient’s medication history to the payer or PBM; relevant member information was already loaded and eligibility information, links to appropriate benefits and formulary retrieved and accessible. The physician could search for drugs by name or therapy class, referencing third-party drug data as well as formulary and benefit data loaded at the point of care. A DUR check was performed, pulling in medication history and other integrated medical history (including, when available, EHR). The physician selected a drug and noted the patient’s choice of pharmacies. The application referenced routing information, addressing the standard NCPDP script transaction to the appropriate pharmacy, including information the pharmacy passed to the PBM, ensuring payment adjudication occurred against the same benefits considered in the prescribing decision.

Cigna’s did not recommend pre-adjudication which was often repetitive, slower than physicians tolerated, and did not fit the work flow. Adjudication required information unavailable to the physician and the actual cost was based on criteria that were not finalized until the claim was processed. Cigna advocated providing up front the best information possible through formulary and benefit loads.

Ms. Swanson noted physicians’, pharmacists’, and payers’ DUR checks considered different data sets and perspectives, serving as useful checks and balances. E-prescribing and fields available in the NCPDP telecommunications transaction for sharing DUR check results would lead to a more efficient, complete DUR process. She noted the claims processing piece was already in place. Pharmacies used the NCPDP telecommunications standard to submit a claim to the PBM. The PBM validated: the pharmacy against the NCPDP pharmacy directory, prescriber against their prescriber files, and patient’s drug coverage against the plan’s formulary, group-level benefit information and other financial considerations. DUR and the patient’s medication history were checked for conflicts.

Pharmacies used information shared by the router and the NCPDP script transaction to electronically send physicians renewal requests. Physicians essentially generated a new prescription. Ms. Swanson emphasized a national prescriber identifier was necessary.

PBM PERSPECTIVE

• Mary Ryan, RPh, Vice President, Pharmacy Regulatory Group, Medco Health Solutions

Dr. Ryan said e-prescribing processes provided enough information that prescribers could make better decisions for patients, reduce medication errors, free time for pharmacists to discuss patients’ therapy, and it would ultimately result in more cost effective prescriptions. She urged NCVHS to adopt standards developed by SDOs and in place that enabled free flow of information and would encourage adoption of e-prescribing. She clarified that Medco advocated standards associated with RxHub, not RxHub as a sole solution. Medco recommended the MPI, X12 270 271 standards, and the batch load of patient demographic information accompanying MPI for eligibility. She noted benefit information to the prescriber would be a batch load created through RxHub. Patient medication information or history was based on HL7’s medication history messages and NCPDP messaging RxHub used to create information for doctors. Provider messaging NCPDP developed would be used for participating providers. New prescriptions, renewals and changes would use NCPDP script and HL7 prescription messages.

Medco did not recommend prior authorization as part of the real-time transaction for e-prescribing, noting the transaction was not well supported. However, Dr. Ryan said Medco recommended standards be associated with the transmission of the requests and authorization codes. She noted transmission of the authorization code was part of the script standard and had a position on NCPDP script.

Dr. Ryan said RxHub standards were developed in a consensus process drawing upon public work group sessions and input from technology vendors, pharmacists and others in the industry. Existing standards were expanded to make the application broader and include the front-end process providing information to the prescriber about a patient’s medical history and eligibility. Twelve partners used the standards in production; ten waited to go into production; eight more were being certified. Others used the transactions available on the RxHub Web site as a basis for development.

Medco did not believe demographic information required a national payer or patient identifier. Dr. Ryan suggested developing either the state license number, DEA, or HD idea as the prescriber identifier. Medco advocated the NCPDP provider ID for the pharmacy identifier and Rx Norm for drug codes. Dr. Ryan supported collaborative efforts to standardize the SIG, noting that SIGs already standardized covered 80 percent of the prescriptions dispensed.

She said MMA preemption was broad, overcame problems associated with state rules and regulations regarding e-prescribing, but had to be extended to pass Medicare Part D. State rules and regulations prohibited e-prescribing or imposed severe restrictions. Prescription formats differed and other differentiations and distinctions abounded in state forms. Preemptions could authorize any electronic system meeting minimum standards without requiring individual state board approvals, overcoming restrictions related to patient consent and use of intermediaries.

Dr. Ryan said concentrating on what constituted a valid signature rather than how to verify a valid prescription derailed the concept established in many states that pharmacists were obligated to ensure a prescription was legitimate. She noted e-prescriptions could be validated more powerfully than paper prescriptions through audit trails and security controls. Contending that authenticating the prescription’s source was most important, she asked NCVHS to be technology neutral in describing the signature and focus on system security.

Discussion

Express Scripts’ dilemma in implementing a uniform system across their company was finding a common denominator for five sets of state laws. Noting the statute stated anything contrary to the standards or restricting ability to carry out MMA’s e-prescribing program could be preempted, Mr. Rothermich pointed out that software vendors could not be expected to develop 53 separate applications for Medicare and each state. He emphasized that whatever was developed had to be the standard for e-prescribing; a single standard indicating a script that came in through a system meeting these requirements was authentic in any state would solve a huge problem for everyone.

Mr. Rothermich clarified that RxHub was launched in February 2001 by Advance PCS (now part of Caremart), Medico Health, and Express Scripts. Asked to explain Cigna’s interest, Ms. Swanson said RxHub met needs of payers in a payer-neutral way, allowed interaction with a variety of POC software solutions, and enabled physicians to drive process in a multi-payer environment. Mr. Rothermich noted RxHub founders, like other payers, had sought a solution where everyone did not have to re-engineer what took years and millions of dollars to develop.

Mr. Blair thanked the panel and disclosed that, knowing he was blind, their representatives and others from the PBM payer community met with him early in the week and explained the graphics shown in the meeting. He observed that payers and PBMs concurred about RxHub and that the content and benefits of these messages was clear, enabling e-prescribing to move forward. Observing that NCVHS traditionally favored accredited ANSI-standards, he asked about taking RxHub standards to an ANSI-accredited SDO with consensus-based, open meetings. Teri Byrne from RxHub noted SDOs had the best processes for changes made through consensus. She recommended adopting the standards as they were and then taking them through the change process. Mr. Blair acknowledged that RxHub’s process was valuable, pragmatic and faster than SDOs, but emphasized going through the ANSI accreditation process as soon as possible so everyone was represented equally.

Responding to an observation that lack of e-prior-authorization tilted prescribers away from representing patients, Mr. Rothermich depicted prior authorization as a benefit rule relating to very specific, high-cost drugs. Non-formulary agents were third-tier and cost more by “design.” Dr. Ryan noted pre-load information tagged drugs requiring prior authorization. Qualification discussions were complex and, at that point, not available real-time.

She pointed out that currently prescribers did not have an HCIdea to include in the prescribing process as they did the state ID, license number or DEA. She noted a national patient identifier (NPI) could be used if extended beyond the current NPRM limiting it to Medicare or Medicaid prescribers. Ms. Byrne agreed HCIdea was close to being the answer, especially from a router perspective. The HCIdea file could be purchased; information matched and distributed. It was backward compatible, so everyone did not have to adopt it. Ms. Swanson noted a workaround was used for routing, but believed a national prescriber identifier would be better. Ms. Byrne clarified that RxHub standards were free to connectors. Participants had to have an NDA with RxHub prior to distribution of the implementation guide. She noted RxHub testified they would work with NCPDP to become an ANSI-accredited standard.

Asked why prescriber and location had to be combined into a single unique identifier, participants noted most systems were built around DEA and a separate field had to be created. A routing perspective also called for an identifier location. Location was allowed using a master key for doctors and sub keys for other locations. Tech vendors dealt with renewals by providing Web sites.

Ms. Byrne reported little research had been done on SNOMED, but it appeared useful in SCRIPT and Telecom for conveying disease state or the basis for a drug being prescribed. Noting SNOMED would not be used for the drug identifier, Ms. Byrne recommended linking to DKBs.

Mr. Rothermich clarified that real-time transactions to some Internet-based knowledge bases of formulary information were available, though not efficient. He pointed out there was no reason to download formulary files in real time. Ms. Byrne noted RxHub developed a real-time formulary request/response in the original standard; an Internet-based request/response to RxHub had not “taken off” because it still took too long.

Mr. Rothermich explained the formulary would contain tiering information and support relative costs. He acknowledged physicians preferred actual costs, but contended they would not have or choose to wait for all the data. He noted co-pays involved considering numerous components and required pre-adjudication. Ms. Swanson pointed out that many benefit designs involved a percentage of cost and deductibles. Ms. Byrne observed that Re-Hub allowed for actual amounts, but what was available depended on what the vendor was comfortable displaying and PBM was comfortable sharing.

Asked if MPI would work across prescribers and pharmacies, Ms. Byrne said NPI would be incorporated into MPI and local identifiers. Mr. Rothermich contended NPI would add cost to the system and be unnecessary with MPI technology. Asked how a consumer could determine a drug’s lowest out-of-pocket cost, Ms. Swanson noted most payers provided information about their benefit plan on their Web sites.

PHARMACEUTICAL MANUFACTURERS’ PERSPECTIVE

• Peter Brandt, Senior Vice President, Pfizer Global Pharmaceuticals

Mr. Brandt said both technology standards making e-prescribing possible and policy standards establishing ground rules were essential components of a functional, sustainable e-prescribing infrastructure. He said results of the Rand study of e-prescribing quality standards Pfizer presented to the Subcommittee in May helped them develop three basic tenets on e-health: put the patient first, support professionals’ clinical judgment without controlling them, and ensure the integrity of information available for clinical decision-making. Mr. Brandt emphasized e-prescribing should support both the patient-physician relationship and shared decision-making, without exercising control over either.

Recalling in May the Subcommittee heard testimony suggesting there was no longer a reason for concern about external stakeholders interfering with prescriber’s decisions, Mr. Brandt testified that, within the last year, companies proposed to both Pfizer and Amacorps financial incentives and an electronic method to influence the patient-physician prescribing moment. Pfizer asked NCVHS to: recommend standards for ensuring that a zone of autonomy surrounded the physician-patient relationship, protect it from commercial messaging (i.e., any influence from any third-party), and establish carefully crafted policy and technical standards protecting autonomy.

Pfizer believed third-party information relevant to the decision-making process should be made available. Mr. Brandt noted no mechanism ensured information presented was correct, reasonably applicable, properly sourced, or subject to consistent and rigorous standards of accountability or balance. An appropriately designed e-prescribing tool could present the source of information, but he emphasized it would take a policy standard reflected within the technical standard to enforce it. Pfizer called for such a policy standard to assure information presented within the e-prescribing environment was properly sourced and parties issuing information were subject to the rigorous standards of accountability and balance FDA required for pharmaceutical manufacturers.

Mr. Brandt emphasized an e-prescribing tool merely enforcing application of a population mean or generalities rather than accounting for a patient’s individual clinical needs, life circumstances and personal values kept from the physician’s clinical decisions factors that enabled patients to receive the care appropriate to their unique needs. He stressed no single feature was insignificant when evaluating individuals (e.g., 1 in 300 patients could not tolerate gluten in their diets). Adding differentiating features to the e-prescribing process allowed prescribers and patients to articulate their needs at the point of care and receive appropriate treatment. Noting standards were not in place for cataloguing and communicating differentiating features, he asked NCVHS to recommend adapting FDA’s structure product labeling initiative as source of this content and modifying NCPDP script and HL7 to transmit it.

He said the best way to manage prior authorization was to make it a seamless part of the prescribing process. Current transaction standards did little to address areas, such as prior authorization, where physicians felt the greatest administrative burden. PA process became more a means to control clinician behavior than an opportunity to optimize patient care. Physicians were left to resort to a paper or phone-based process designed to be inconvenient.

Mr. Brandt said formulary should be structured and standardized so e-prescribing and EHR vendors could present information consistently and without bias, use intelligent tools to notify clinicians when prior authorization requirements were met, send the authorization request to the payer, and have prior authorization code accompany e-prescriptions. Emphasizing efficiency, not inconvenience, should drive the evolution of e-prescribing, Mr. Brandt asked NCVHS to recommend development of technical and policy standards supporting structured formulary and automated prior authorization processes.

PHARMACEUTICAL MANUFACTURERS’ PERSPECTIVE

• Michael Weinberger, , Executive Director, Prescribing Alliances, Johnson & Johnson Health Care Systems Managed Markets Group

Mr. Weinberger expressed Johnson & Johnson Health Care Systems JJHCS’s concern that both the mode of presentation and messaging could be used by e-prescribing vendors offered payments to steer prescription selections into compliance with preferred formulary options. Mr. Weinberger emphasized that physician choice should not be skewed in favor of preferred drugs when those drugs were not in the patient’s best clinical and financial interests. He also expressed concern about potential for selective, incomplete presentation of drugs. Mr. Weinberger stressed that e-prescribing solutions should present drugs in a single consolidated neutral list and provide all relevant clinical and financial prescribing information. Physicians should not have to navigate multiple screens to see all drug choices.

JJHCS considered inappropriate messages that aimed at influencing physicians indicating an intent to prescribe in a certain category before clinical information could be taken into account. Mr. Weinberger said pop-up windows were neither neutral nor unbiased and had no clinical value. He recommended NCVHS adopt compliance guidelines and certification standards for vendors and networks that ensure a level playing field for all parties.

PHARMACEUTICAL MANUFACTURERS’ PERSPECTIVE

• Charles Jaffee, M.D., Director of Medical Informatics, AstraZeneca

Noting MMA charged NCVHS with recommending technical and policy standards enabling e-prescribing and that this process could also serve as a model for other NHII standards, Dr. Jaffee emphasized that policy should transcend parochial and short-term needs. Deployment could support patient adherence as well as reduce cognitive and systematic errors. Noting they heard short-term benefits for physicians, Dr. Jaffee stressed this also could be a first step in integrating technology into the process of patient care and truly personalized medicine.

He emphasized policy imperatives recommended by NCVHS could substantially alter the practice of choosing therapies and urged members to remain aware of the balance between patient privacy and requirements for access to data for public health use and research needs.

Dr. Jaffee noted industry considered providing safe harbor essential and recommended NCVHS also promote funding of essential technologies and encourage innovation benefiting providers, patients and their families. He emphasized that policy mandates would foster more rapid physician adoption, better defined patient benefit and more cooperative development of supporting standards. Dr. Jaffee said AstraZeneca sought to participate in development of decision support technology and content that recognized the total cost of care.

Discussion

Mr. Weinberger clarified that JJHCS’s overriding concern was that all prescribing options appear on a single screen. He said a neutral presentation gave physicians access to all information when they made their decision and in a way that made accessing prescribing options manageable. Participants noted initial display as alpha was optimum and a well-designed system with neutral presentation enabled physicians to customize the list with their choices. Mr. Weinberger said the composition of the P&T committee in part determined the fair system of display. Dr. Jaffee noted he had chaired a formulary committee and believed that, as wise as a collective body might be, the ultimate decision at the point of care rested in the physician’s hands; that moment and process were most relevant.

Mr. Brandt advocated holding information displayed by e-prescribing standards to the clinical rigors prescribed by FDA for regulating marketing of drugs; he said, at a minimum, precise sources should accompany descriptions. Off-label use could be addressed separately. Mr. Brandt said Pfizer was hopeful NCVHS would determine policies ensuring the zone of autonomy and how information was sourced. He advised eliminating third-party primarily financially-driven messaging at the point of prescribing. Noting everyone strove to track the value of given therapies, including patient interventions and self-management, and bring it to decision-making at the point of care, he cautioned about setting technologically based standards that precluded capturing that information.

Ross Martin from Pfizer proposed a certification requirement that any vendor providing e-prescribing tools could not make money based on physicians’ clinical decisions. Dr. Cohn suggested this was more a policy than standards issue suitable for a complaint-driven process similar to HIPAA. CMS could investigate if there was too much commercial information. Mr. Martin questioned waiting until commercial information became such a burden it had to be exercised. He noted MMA did not clearly define a commercial message and observed that anyone with a financial stake in that decision might pitch such a message. Dr. Cohn noted the Subcommittee recently heard testimony in hearings with the Privacy Subcommittee about the difficulty of differentiating between marketing and health improvement. Mr. Weinberger agreed, noting the example of vendors offering for a fee to pre-populate products on physicians’ favorites list.

Participants pointed out that, as the environment stands, safe harbor is afforded certain entities, not others, creating a biased decision process. Noting pharmacists were part of the continuum of health care and in some states had a mandate to educate the patient, Dr. Jaffee said they could not be excluded from policies mandating neutrality. Legislative provisions excluded pharmaceutical companies from financing infrastructure support that others could give; they wanted to contribute as well. Mr. Weinberger explained the issue of rebates: manufacturers paid rebates to entities that managed drug benefits (e.g., PBMs) in order to gain preferred placement on a formulary. In some cases, a portion was passed to the entity that hired the PBM to manage the benefit. Rebates did not go to prescribers.

Dr. Jaffee said the diagnosis should be sent to the pharmacist; from a population and AHRQ point of view, having the rationale precede intervention brought modeling into a new era. Mr. Brandt noted that understanding outcomes depended on this input. He recalled earlier comments about ensuring standards supported rather than controlled decisions, noting that could mean ensuring there was a gatekeeper if a drug was tagged inappropriate for a diagnosis. Ms. Lee agreed pharmacists should challenge for errors, but emphasized the responsibility rested with the physician. Mr. Weinberger agreed having the rationale why certain products were prescribed would be helpful. Dr. Warren noted it was important to consider people’s responsibilities when determining standards for what should be passed: it mattered that pharmacists had the problem list if they provided patient education.

Mr. Brandt clarified that emphasis on structured product labeling did not preclude information from other sources (e.g., peer-reviewed articles) being available to the prescriber, so long as they were appropriately sourced. Mr. Martin noted the distinction between a company with an editorial board whose earnings came from selling their drug compendia and another whose earnings were based on how their content leveraged third-party interests. Mr. Brandt said the US Pharmacopeia therapeutic classification list, NDF-RT or at least mapping should be used for standards. Near-term, sponsors could define their own classifications.

Mr. Weinberger clarified that his definition of messaging also referred to messages attempting to get physicians deciding what to prescribe to switch based solely on a financial motivation. Mr. Rothermich suggested considering a viable business model for these companies, incentives from other parts of the chain, and better safe harbors so more people received value and supported the model. Mr. Blair observed that this seemed to not be a standards issue but an important related issue about the design of software applications and/or the software or network vendor directly affecting interoperability standards.

PHARMACY PERSPECTIVE

• Lonny Wilson, CEO, Pharmacy Providers of Oklahoma

Mr. Wilson presented the independent community retail pharmacies’ perspective on e-prescribing. Noting e-prescribing could alter the professional roles and decision-making process of pharmacists and physicians, he urged that policy standards be developed and enforced to ensure these roles and focus on providing the most cost-effective therapy and maximum positive outcome for patients was preserved. Mr. Wilson emphasized that policy standards should ensure that information shared between pharmacists and physicians remain unchanged to protect the integrity of the prescribing process. E-prescribing policies should be about providing safe and cost-effective treatment; no commercial messaging or advertisement attachments should be allowed. Formulary process should be based on the quality of outcome; cost was a secondary consideration. Policy standards should ensure patient freedom and right to choose a pharmacy. Standards should also facilitate collaboration of physicians and pharmacists to provide DUR process. Mr. Wilson pointed out that retail pharmacists routinely monitor and coordinate multiple physician drug therapies and were uniquely positioned to provide the most comprehensive DUR. He noted PBMs have no access to prescriptions obtained by cash, other plans, OTC drug purchases or physician samples.

Mr. Wilson noted PBM and Medicaid contracts accounted for over 90 percent of prescriptions dispensed in community retail pharmacies and these pharmacies paid for most telecommunication costs associated with claims transmission to PBM processors. He said gross profit margins had eroded to dangerously low levels as a result of PBM “take-it-or-leave-it” contracts and independent community retail pharmacies’ inability to negotiate. Contending that community retail pharmacies could no longer afford to fund a disproportionate share of ongoing costs associated with e-prescribing transactions, Mr. Wilson asked that financial grant provisions of MMA be expanded to include pharmacies to offset some of these costs.

PHARMACY PERSPECTIVE

• David Kilgo, R.Ph., Director of Third Party Operations and Systems, Wal-Mart Stores

Dr. Kilgo said e-prescribing technology should be used as a tool to enhance the patient-physician-pharmacist triangle. Noting freedom of choice included selection of appropriate therapy at point of care and pharmacy, he said a narrow definition of appropriate messaging was important to limit potential “noise” that could develop if this step was commercialized. He emphasized sufficient safeguards had to be built into e-prescribing so choice of retail pharmacist remained available without financial penalties to patients. DUR must be mandated.

He noted the NCPDP script standard, when fully implemented, would provide necessary information for preparation of prescriptions. Retail pharmacy exchanged electronic claim information for 15 years through secure network connections using standards developed by NCPDP. Dr. Kilgo noted this expertise was instrumental in developing the script standard. The NCPDP script standard was sufficiently robust to allow messages containing relevant information about the patient, drugs and prescriber including e-prescription and refill authorization requests and free-form messages between prescriber and pharmacist. The standard would meet MMA requirements for electronically sending prescriptions between them. Dr. Kilgo recommended NCPDP Telecommunication Standard 51 (currently accepted, fully implemented and HIPAA approved) for prior authorization, DUR and copay information.

Dr. Kilgo noted drug products were identified with the NDC throughout the industry, including claim billing. Code sets used by Wal-Mart included NCPDP script, NCPDP Telecommunication 51, Universal Product Code, NDC and DEA. Noting script standard had sufficient fields for transmitting information necessary for pharmacists to serve patients, he cautioned that NCPDP’s decision to add NDC to the fields brought a level of granularity that could rob the process of efficiencies the system was designed to provide and present problems to physicians. Noting GPI adequately identified products and granted sufficient flexibility for the pharmacy to select specific products, he suggested it as a legal standard.

He identified two “glaring” gaps in the code sets: patient and prescriber identifiers. He emphasized adopting a nationally-recognized patient identifier separate and unique from the Social Security number. Noting NPI became the HIPAA-sanctioned identifier for healthcare provider, he pointed out the inability to associate NPI with multiple practice locations and that not all prescribers were required to have an NPI. SureScripts and other e-prescribing vendors found it necessary to develop their own system for uniquely identifying practice locations. Directions for use or SIG was another gap. Many of the directions given with a prescription were conveyed using commonly-used abbreviations. Standardization of abbreviations would improve the process and reduce potential error.

Cautioning that insufficient resources for the medical practitioner, physician or pharmacist to purchase or upgrade PMSs for sending and receiving e-prescriptions could be a barrier in rural markets, Dr. Kilgo advised NCVHS to consider grant money to assist these practices. Funds were also needed to educate users in the full range of functions e-prescribing offered.

Dr. Kilgo emphasized that SCRIPT’s technology base offered a “launching pad” for e-prescribing and use of that technology would leverage the investment many stakeholders already made. He said e-prescribing’s success hinged on the continuity of regulation of state boards of pharmacy and payers. Some drug products were covered under Medicare Part B, which required a prescriber’s signed order, eradicating e-prescribing’s efficiencies. Dr. Kilgo proposed NCVHS consider time lines and milestones for adoption and implementation in phases, thus allowing current functionalities to be a base for building future enhancements.

PHARMACY PERSPECTIVE

• Mark Gregory, R.Ph., Vice President Pharmacy & Government Relations, Kerr Drug

Dr. Gregory noted many North Carolina community pharmacies in Kerr Drug’s regional chain were the only source in town and those pharmacists were key healthcare providers. He outlined the pharmacist’s role as a safety net in the fulfillment and distribution of medications. Dr. Gregory pointed out the investment already made by retail pharmacy operations to make the dispensing process safer and more efficient and cautioned that another stakeholder or dispensing model attempting to handle any of those processes could burden the system, jeopardize safety and create inefficiencies.

He itemized a number of dispensing efficiencies community pharmacy integrated into the fulfillment process with a significant investment of technology, time and manpower. Electronic adjudication. the vehicle for e-prescriptions, had been in place for over a decade. Workstations, workflow cues imbedded in dispensing systems, and targeted responsibilities for ancillary personnel were incorporated in the filling process. Bar coding and prescription scanning enabled quality-assurance checkpoints. Interactive voice response allowed patients to phone prescription refills in efficiently and informed patients of remaining refills. As physician practices adopted electronic connectivity, electronic requests replaced faxes to physicians’ offices; pharmacies automatically outbounded requesting refills. Other efficiencies included counting automation, optional pre-fills for maintenance medications, and electronic documentation storage of signatures.

Dr. Gregory emphasized the need to use the script standard (which had gone through rigors of adoption, the NCPDP process, and was accepted by pharmacy software vendors, community pharmacy organizations, database providers and others) for transactions involving physician/pharmacist e-connectivity. SureScripts’ system allowed patients to choose which pharmacy filled their prescription. All Kerr pharmacies could receive directly into the workflow queue new e-prescription and refill approvals. Dr. Gregory emphasized adopting an alternative standard or model that enabled building upon the significant investment already in place in community pharmacies. He emphasized the patient/physician/pharmacist relationship was increasingly critical and urged that the e-connectivity standard and model not allow stakeholders to incorporate marketing messages into the medication distribution process.

Dr. Gregory recommended that NCVHS: (1) find a way to enhance physician adoption through financial grant opportunities for investment in training, purchase and acceptance of the new technology, (2) supplement pharmacy providers’ investment with grant incentives for adopters, and (3) fund entities to measure outcomes gauging safety and efficiency successes.

PHARMACY PERSPECTIVE

• Mike Simko, R.Ph., Manager, Pharmacy Systems, Walgreens Health Services

Walgreens initiated electronic communication between pharmacists and physicians utilizing an email-like structure for refill authorizations15 years ago. Dr. Simko said e-prescribing and improved patient healthcare depended on commonality. Standards had to ensure integration of complete, accurate information in pharmacy operating systems. Slow adoption was linked to a myriad of formats and methodology. He noted the disparity between EDI prescriptions and e-generated and faxed prescriptions.

Standards were in place for e-prescription transmission between pharmacies and physicians’ offices. NCPDP script standard was widely adopted, addressed the bi-directional functionality in the transmission of prescription information MMA required, and met Medicare patients’, pharmacists’, and physicians’ e-prescribing needs. Standards addressed potential for added functionality: patient benefits information, medication history, allergy/health conditions. Efforts underway would interface NCPDP with HL7 to cover inpatient in long-term-care settings.

Dr. Simko advised that NCPDP’s provider identification number, adopted for processing/

payment of prescription drug claims, worked as a pharmacy identifier code set for e-prescribing. He urged NCVHS to adopt the NDC number as a standard for medication identification, noting generic medications were a growing cost-effective healthcare delivery area and the generic drug issue had to be addressed. Pharmacies selected generic manufacturers based on safety, efficacy, costs and product availability and the process controlled costs for patients and the industry. Sending manufacturer-specific generic prescriptions electronically would delay patients receiving medication and impede acceptance and adoption of e-prescription services. Inhibiting generic-manufactured product selection might most adversely affect seniors on chronic-care medications dependent on generic alternatives’ cost savings. He suggested GPI might address the issue; noting RxNorm was not used in pharmacies and adoption would be problematic.

Dr. Simko noted lack of an accepted, non-proprietary SIG prescription database and pharmacies’ need for exact provider instructions. Medication directions often required full free-form text. NCPDP script SIG standard or translation methodology might have to be adopted.

Pharmacy systems had to integrate e-prescribing to realize benefits. Refill authorization requests had to be automated to ensure uninterrupted compliance, critical monitoring of progress in electronic medical records, and stress reduction for pharmacists and physicians.

Third-party payer groups’ databases had no non-third-party orders. Pharmacy systems monitor medications along with patient compliance. Adding allergy information, health-condition codes and non-prescription drug usage provided a comprehensive profile of a patient’s medical condition, drug therapy compliance, and basis for effective DUR review. Pharmacists were required to perform DUR and offer clinical consultation. Dr. Simko said, in some cases, pharmacists knew more about medication and treatment than physicians.

Dr. Simko said future enhancements might include additional messaging, patient medical-record information, lab results, patient weights and diagnosis. Connection for refill authorization requests/responses and transmitting new medication orders had priority. Additional features and functionality could be applied over time. Transmission should be seamless and easily adopted. No barriers could hamper connectivity, interfere with patients’ choices, or delay implementation. Adequate security and system safeguards were needed to prevent and detect unauthorized access, modification or manipulation of e-prescriptions. Noting IMS statistics indicated 20-30 percent of written prescriptions were never brought to a pharmacy, Dr. Simko reported more medications were filled when e-prescribing was utilized.

Physicians should (1) have access to neutral, unbiased information and covered outpatient medications; and (2) view with ease necessary information, including information about preferred/non-preferred drugs on and off formulary without navigating multiple screens. Information should be fact-based and transparent, banners/advertisements labeled paid advertisements, and both incentive payments to display information in a particular way and sources must be disclosed. COB information should be granular enough to provide the payer ID number. A fair depiction of benefit structures should be available at the point of prescribing.

Discussion

Dr. Simko recommended implementing SIGs slowly, ensuring text was translated into pharmacy systems exactly as intended and working towards agreeable standardized SIGs. Dr. Kilgo explained a GPI was a proprietary number generated by Medispan giving a group of generics a single smart number. Asked about dangers of routing scripts to manufacturer-owned mail order pharmacies, Mr. Wilson said the best patient care occurred through the patient/pharmacist relationship. He noted some PBMs required mail ordering secondary refills.

Dr. Simko noted Walgreens personal medical history was on line and patients could include OTC purchases and prescription medication from other pharmacies. Dr. Huff said one could argue that that any care provider should be able to access such an online service. Participants agreed the goal should be getting a comprehensive list to the provider at the time of prescribing and that having prescription drugs part of an electronic medical record would be a solution. Testifiers confirmed the SIG field in NCPDP script was free text; no one had an issue with what should be on the list.

Acknowledging that the testifiers’ background message was go slow, Dr. Huff pointed out the Congress told NCVHS to go fast and Secretary Thompson decided to go faster and that was how NCVHS was moving. Emphasizing that standards and workflow processes did not yet exist for some things, testifiers said they wished NCVHS would go even faster with connectivity, carefully adding features and functionality (centralized medical record, DUR checks at the doctor’s office) in gradual steps.

Noting they heard several requests for incentives, especially for rural areas, and that HHS had embarked on incentives for EHRs, Dr. Steindel asked if PMS and e-prescribing could be piggybacked onto EHRs. Dr. Kilgo noted the capability of the physician’s office was the key. Mr. Wilson said modern IT was critical, the particular way was irrelevant. Dr. Kilgo reiterated that small, rural pharmacies were also critical.

Asked how important it was that pharmacists have lab information, participants noted specialty-type medications needed lab values and it would be good to have them.

Dr. Simko clarified that physicians chose from an encoded list; the problem was people used different codes. Adopted standards would not be binding for three-to-for years giving people a chance to translate any codes used to standard codes. Dr. Kilgo cautioned about two points. If that information was to be as granular as NDC, it would be too slow for physicians. And there were many versions of generics.

GUEST TESTIFIER, Eugenia Marcus, M.D., FAAP, Executive Committee, Steering Committee on Clinical Information Technology, Massachusetts Branch, American Academy of Pediatrics

Dr. Marcus emphasized how children’s’ needs differed from adults. Too often, pediatricians had to modify products designed for adults. Frequently modifications did not work. Noting there were many nuances to consider, she asked NCVHS to involve end-user clinicians. She also pointed out that pediatricians had to track parents’ name (which might be different) and there might be multiple residence addresses and fill scripts at different pharmacies. Pediatricians had to know the child’s age and weight and date recorded. A range for different weights should be in the product code. Software should do drug food interactions as well as checking, drug interactions and drug diagnosis and allergy checking.

Dr. Marcus noted some medicines were not approved by the FDA for use in children under certain ages; alerts should be provided but pediatricians should be able to override them when necessary. Pediatricians also had to be able to put on the prescription the diagnosis, fractions for SIG, and convey special circumstances in a note section. Formulary should not prevent other choices. The prescription should be able to be sent electronically, including electronic signature and contact information for the prescriber. Software needed an ability to undue a pick from a list or recall/cancel a prescription.

Dr. Marcus noted she used a compounding pharmacy to accommodate reluctant participants who would not take anything unless it was peanut-butter flavored, but she said this was easily done on the phone and did not need to be included in e-prescribing. One of the biggest barriers was that most her colleagues’ offices were not connected.

Discussion

Participants noted SCRIPT offered cardholder information on multiple parents, supported canceling, free-text notes, fractions (dependent on system design), height, weight, date and time. Members observed that they were hearing about and considering three frameworks: technical, functional (appropriate for different emerging designs) and policy standards.

OPEN MICROPHONE

Dr. Braithwaite noted two issues. First, ubiquitous secure connectivity was needed; enabling Internet connectivity would involve many standards not yet available. Second, forcing choice in the physician office could be viewed as constricting patient choice. Patients not comfortable with their doctor receiving fill status notifications might consider this a privacy rights issue. Participants suggested physicians be allowed to print prescriptions out manually that were bar coded ensuring automatic “readability, so that patients could be offered a choice.

Participants observed that options for connecting to the Internet were more prevalent than connectivity for e-prescribing to local pharmacies. Non-repudiation was the biggest issue. Bob Beckley with SureScripts said security was in place for routing mechanisms (https, VPN, SSL). He suggested that levels of security that might be dictated were covered under HIPAA. He noted point-to-point lines were still used. Ms. Warren pointed out that access to Internet was a problem in some frontier-level (i.e. lowest level of population per square mile) areas.

Mr. Schueth remarked that five barriers to e-prescribing had been overcome: (1) PDA’s made e-prescribing exceptionally mobile, (2) two solutions, Medimedia and RxHub/CAQH, provide formulary information for 70 percent of a physician’s patients, (3) 55 percent of retail pharmacies participate, (4) 48 states allow e-prescribing, (5) RxHub enabled medical history. Mr. Schueth noted prioritization was needed to overcome remaining barriers. Physicians could prescribe electronically in three categories of solutions: EHR, computerized physician order entry (CPOE), and e-prescribing (i.e., multi-function point-of-care applications). Mr. Schueth noted the adoption rate for EHR was 14-18 percent (Dr. Brailer’s study); CPOE, four percent (KLAS), e-prescribing, 2-5% (personal experience). He suggested overcoming lack of adoption through incentives and assistance in purchasing. He recommended: adopting NCPDP SCRIPT, Hl7 orders and crosswalk; interfaces between PMS and e-prescribing or EHR (noting there was no need for a new standard; HL7 was enough); MMA preemption; HL7 standards for CPOE systems in hospitals with source systems; and identifiers.

Ross Martin from Pfizer contended prior authorization was largely a tool to obstruct behavior. Remarking that the example of growth hormone therapy had branching logic that could be structured, he suggested that questions about prior authorization uncodable according to HL7-supported vocabularies were inappropriate to ask clinically. Mr. Martin proposed a verification of the protocol. Participants suggested requiring documentation. “P.A. fulfilled” would be an ultimate goal to be checked through documentation in an EHR. Monitoring should be performed on the prescriber if necessary. In some cases, joint clinical judgment might be necessary. Dr. Ryan recommended not delaying phase one for the two percent of the prescriptions dispensed that were prior authorizations, solely because they were not codified. Asked if the two percent might reflect how difficult it was to go through the preauthorization process, she remarked that most drugs were simply formulary or non-preferred drugs and did not require a special decision unless a pharmacist or physician wanted to move a non-preferred drug into another tier. Dr. Fitzmaurice emphasized balancing between acting now and having legacy systems built with no way to put in functionality because of all the variables that would have to change.

Participants agreed decision-support algorithms and structure for formulary standards were needed and suggested pre-authorization might be ridden in moving forward the whole EHR system. They noted pre-authorization drugs were not on formulary, few, and differed by clients. Donna Wade said Medco would not want to see standards about which questions should be part of each algorithm.

RxHub said they would submit for the Subcommittee’s review their proposal of standards, identifying the status of implementation guides and a timeframe for submittal to the SDOs.

Dr. Sullivan observed that prior authorization was a bigger issue with Medicaid patients. Medicaid did not have funds to do even the paper form for formulary aggregation. He asked NCVHS to invite practicing physicians to hearings to ensure an understanding of their work flow and patients’ needs. Dr. Sullivan emphasized that the e-signature for controlled substances had to be resolved and urged FDA to move faster. He noted preemption was needed. Dr. Sullivan expressed concern about always sending a diagnosis to pharmacists, preferring when necessary to receive a request. He preferred his desktop over his PDA: remarking that “big screen real estate” was essential. Noting pharmaceutical companies frowned on putting messages between the doctor and patient, Dr. Sullivan suggested a fraction of what was spent on direct-to-consumer advertising could go to support e-prescribing

Ms. Byrne noted there was an X12 278 standard for requesting prior authorization. She did not know if it met all e-prescribing needs. Ms. Byrne suggested that requests to set standards for workflow or functional standards be extended to pharmacy software and other players. Members said they heard a need for workflow standards; none had been identified, but there might be workflow issue recommendations to consider. The issues had to be considered in whatever standards NCVHS recommended. Technical standards should support workflow. Policy standards might be needed and regulated in some cases.

Dr. Cohn read an excerpt from a letter from Senator Charles Grassley reminding the Subcommittee of MMA provisions aimed at addressing issues that could compromise e-prescribing programs and of the provisions’ underlying intent. “The MMA requires that e-prescribing standards allow for the messaging of information only if it relates to the appropriate prescribing of drugs, including quality-assurance measures and systems to reduce medication errors to avoid adverse drug interactions and to improve medication use. The provision is intended to preclude the transmission of commercial information and to ensure the presentation of neutral and unbiased information with the ultimate objective of protecting patient choice. The conference report clarifies Congress’ intent by stating the following: ‘The conferees do not intend for e-prescribing to be used as a marketing platform or other mechanism that could unduly influence physicians’ clinical decisions. The conferees intend for prescribing health professions to have ready access to neutral and unbiased information on the full range of covered outpatient drugs available.’”

-DAY THREE-

OVERVIEW OF LIST OF REQUIREMENTS/GAPS TO BE SENT TO SDOS AND TERMINOLOGY DEVELOPERS AND SUBCOMMITTEE, Margret Amatayakul, independent consultant assisting the committee

Ms. Amatayakul and the Subcommittee considered diagrams depicting information flows related to e-prescribing and identified standards and gaps in that flow.

ADDITIONAL SUBCOMMITTEE DISCUSSION, Simon Cohn, M.D. and Jeff Blair

Participants considering information flows related to e-prescribing and identified standards and gaps. Members honed an analysis working document identifying needs, gaps and key unresolved issues to be shared with SDOs, terminology developers and others along with an initial list of low-hanging fruit. SDOs and other developers will be asked to confirm gaps, limitations and how these might be resolved. Members noted standards for e-prescribing (e.g., drug terminologies, SIGs and devices, complementary therapies, medication/medical history, and functionality) had to be in synch with CHI and PMRI terminology standards NCVHS recommended last year. Important related issues included insights and policy recommendations, work flow, record retention, state preemption, quality, formulary creation, policy standards free of commercial bias, transmission, conformance testing, patient safety, privacy, security and e-signature. A cover letter will clarify that this is the full scope of what the Subcommittee sought to understand; not necessarily everything would be included in the initial or subsequent recommendations. Next steps involve considering the next version Ms. Amatayakul will e-mail to Ms. Friedman by early next week and discussing further suggestions for modifications and improvements. A conference call was scheduled for August 4.

Planning for Next Meeting, Simon Cohn, M.D.

Members discussed the August 17-19 hearings currently being structured to ascertain that the right interests were represented so they could come away with a comprehensive view linked to perceived gaps and recommendations and, hopefully, an initial set of recommendations to share with the full NCVHS in September. SDOs and terminology developers will be asked to testify about gaps being harmonized and where synchronization was necessary. NLM will be asked about the status of mapping. Written background material will be requested in advance. Dr. Cohn planned to limit the full testimony to a day-and-a-half, ensuring time for Subcommittee discussions of what members were finding and assembling.

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I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

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Chairman, Date