Collaborative Outreach

Office of the National Coordinator (ONC) Federal Advisory Committee Public Comments   |   CMS Comments   |   HHS Comments


Office of the National Coordinator (ONC) Federal Advisory Committee Public Comments:

On December 12, 2013, Shelly Spiro, Pharmacy HIT Collaborative Executive Director testified to ONC HIT Policy Committee’s Certification and Adoption Workgroup regarding the pharmacists and pharmacy clinical perspective on voluntary EHR certification for the Long-Term and Post Acute Care (LTPAC) settings. These are the links for Pharmacy HIT Collaborative’s written comments and ONC’s virtual hearing audio file.

HIT Standards Committee September 18, 2013 - Collaborative Executive Director's Public Comments

On June 26, 2013 the membership of the Pharmacy e-HIT Collaborative submitted comments to Office of National Coordinator for Health Information Technology (ONC) about the Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology. The Pharmacy e-HIT Collaborative is supportive of the continued use of electronic health information exchange across providers and patients, as well as strategies that are effective and feasible to further advance and promote interoperability and health information exchange, and ensure the protection of patient data collected and shared through electronic means, including mobile devices and mobile medical apps. We agree that a coordinated approach and oversight between the health care industry and federal regulators is critical to the successful, safe use of health information technology (HIT) that is being adopted. The Pharmacy e-HIT Collaborative is actively engaged with the Office of the National Coordinator for HIT (ONC) and others in the development of a national strategy and framework for health information exchange. We commend the FDA, ONC, and FCC for moving forward with the request from Congress to thoughtfully examine the regulatory framework concerning HIT and extending the opportunity to HIT stakeholders to provide comments and recommendations for creating the risk-based regulatory framework and strategy health information report.

On April 22, 2013 the membership of the Pharmacy e-HIT Collaborative submitted comments to Office of National Coordinator for Health Information Technology (ONC) about Advancing Interoperability and HIT: Request for Information. The Pharmacy e-HIT Collaborative is supportive of the continued use of electronic health information exchange across providers, as well as ideas that would be effective and feasible to further advance and promote interoperability and health information exchange. We understand that Health and Human Services (HHS) is considering a number of policy levers using existing authorities and programs and that the goal is to develop and implement a set of policies that would encourage providers to routinely exchange health information through interoperable systems in support of care coordination across health care settings. We strongly encourage CMS to reconsider allowing pharmacists to become EPs under this program. As you will see throughout our comments (see attached document) to the questions posed, allowing pharmacists to become EPs would not only encourage more pharmacists to adopt the use of EHR and HIE, but this would also encourage and advance bidirectional communications among EPs and other health care providers, especially with pharmacists, leading to a more coordinated health care system which ultimately would improve patient care.

On February 4, 2013, the Pharmacy e-Health Information Technology Collaborative submitted comments to the Health Information Patient Safety and Surveillance Plan published in the December 21, 2012. The Pharmacy e-HIT Collaborative is supportive of the safety and surveillance plan and the plans’ goals to improve the safety of health information technology (HIT) through safely designed and implemented systems. Pharmacists are ineligible for Electronic Health Records (EHR) incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with Eligible Professionals (EPs). As indicated throughout our comments, pharmacists are EHR users; however, they are ineligible for Centers for Medicare & Medicaid (CMS) Meaningful Use of EHR incentives. Pharmacists provide patient-centered care and services, maintain various patient care records, and as part of the integrated health care team, they are directly involved with patients in various practice settings, particularly with a patient’s medication action plan. Pharmacists are in a strategic position to help improve patient safety, especially, through HIT and EHR. Also as noted our comments, the Collaborative is an excellent and knowledgeable resource, especially, concerning the impact of EHR technology on the pharmacy industry. We strongly encourage you to include the Collaborative in discussions in this area.

On January 14, 2013, the Pharmacy e-Health Information Technology Collaborative posted comments to the Office of the National Coordinator (ONC) HIT Policy Committee: Request for Comment Regarding Stage 3 Definition of Meaningful Use of Electronic Health Records (EHRs) published in the Federal Register on November 26, 2012. The Collaborative is supportive of the proposed measures and objectives for the Stage 3 definition. Pharmacists are ineligible for EHR incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with eligible professionals (EPs). As indicated throughout our comments, that exchange is not at an adequate level today. Pharmacists provide patient-centered care and services, and as part of the integrated health care team, they are directly involved with patients in various practice settings, particularly with a patient’s medication action plan. Pharmacists have standards in place to meet Stage 3 requirements.

HIT Standards Committee September 19, 2012 - Collaborative Executive Director’s Public Comments

HIT Standards Committee July 19, 2012 - Collaborative Director’s Public Comments

HIT Policy Committee July 10, 2012 - Collaborative Director’s Public Comments

On June 22, 2012 the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the Office of the National Coordinator for Health Information (ONC) on Governance Request for Information for the National Health Information Network: Conditions for Trusted Exchange (CTE), published in the Federal Register on May 15, 2012. The Collaborative recommends that pharmacists be included in the CTE governance process so as to integrate pharmacy health information technology (HIT) into the national HIT infrastructure and to assure that pharmacists can connect to other health care providers through secure bidirectional communication. As recognized health care providers, pharmacists play an important role in providing treatments and care to patients. In some settings, pharmacists are first-line-of-care providers, and as such, access to health information through the health information network is critical. Pharmacists need HIT systems that have the functionality and connectivity to support the numerous patient-care services they provide. Integration of pharmacy HIT into the national HIT infrastructure and access to the HIT network will improve communication among health care team members and improve the overall quality of patient outcomes.

On May 6, 2012 the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the Office of the National Coordinator for Health Information (ONC) to the ”Health Information Technology: Standards, Implementation Specifications, and Certification for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Notice of Proposed Rulemaking” published in the Federal Register on March 7, 2012. The Collaborative submits a cover letter explaining its comments. The Collaborative is supportive of the proposed revisions to the permanent Certification Program for Health Information Technology as it applies to the objectives of the EHR Incentive Program in Meaningful Use—Stage 2; however, we are concerned that some of the proposed measures will become unfunded mandates (these areas are noted throughout our attached comments). Pharmacists are ineligible for EHR incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with EPs. As implementation of Stage 2 moves forward; especially with regard to the certification criteria for EHR technology, it should not create additional or financial burdens on pharmacists, such as becoming an unfunded mandate.

Federal Advisory Committee HIT Policy Committee (HITPC) Certification and Adoption Work Group Meeting April 13, 2012 - Collaborative Director's Public Comments

HIT Policy Committee January 10, 2012 - Collaborative Director's Public Comments

The Office of the National Coordinator for Health Information Technology (ONC); request for comments regarding Metadata Standards to Support Nationwide Electronic Health Information Exchange. The Collaborative's 9-23-11 Comments.

Proposed rule, Medicare Program:Shared Savings Program: Accounatable Care Organizations (ACOs) and Medicare Program: Waiver Designs in Connection with the Medicare Shared Savings Program and Innovation Center (42 CFR 435). The Collaborative's comments focus on ensuring the HIT clinical and functionality measures necessary to ensure that pharmacists may exchange data as partners in ACOs. The Collaborative is not commenting on the Medicare Program: Waiver Designs in Connection with the Medicare Shared Savings Program and Innovation Center. The 6-6-11 Comments.

The Office of the National Coordinator for Health Information Technology (ONC); request for comments regarding Policy and Technology Framework for Health Information Exchange (HIE): Privacy and Security Issues. The Collaborative's 5-9-11 Comments.

The Office of the National Coordinator for Health Information Technology (ONC); request for comments regarding Federal Health IT Strategic Plan. The Collaborative's 5-6-11 Comments.

The Office of the National Coordinator for Health Information Technology (ONC); request for comments regarding Meaningful Use Stage 2 Objectives. In addition, is the 2-25-2011 General Comments and the 2-25-2011 Request for Comments on the MU Objectives and Measurements for Stage 2 and Stage 3 spreadsheet.

The Office of the National Coordinator for Health Information Technology; Health Information Technology; Request for Information Regarding the President's Council of Advisors on Science and Technology (PCAST) Report Entitled ''Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward. The Collaborative's 1-17-11 Comments.

HIT Standards Committee requested comments on new initiatives being considered by ONC through the Standards and Interoperability ( S&I ) Framework. The Collaborative's 12-22-10 Comments.

HIT Policy Committee Quality Measures Workgroup requested comments on the meaningful use (MU) of the electronic health record (EHR) quality measurement concepts to be included in Stage 2 and 3 measurement goals 12-22-10 Comment Spreadsheet. In addition, are the 12-22-10 General Comments.

On October 21, 2010 the Collaborative sent a letter to HHS Secretary Sebelius

HIT Policy Committee October 20, 2010 - Collaborative Director's Public Comments

HIT Standards Committee Implementation Work Group October 7, 2010 - Collaborative Director's Public Comments

HIT Standards Committee September 21, 2010 - Collaborative Director's Public Comments

HIT Policy Committee Quality Measures Work Group September 10, 2010 - Collaborative Director's Public Comments

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CMS Comments

On April 8, 2014, the Pharmacy HIT Collaborative responded to CMS Request for Information(RFI) with comments to questions about large scale transformation of clinician practices to accomplish their aims of better care and better health at lower costs. Practice Transformation is a process that results in observable and measurable changes to practice behavior. These behaviors include core competencies: Engaged leadership and quality improvement; Empanelment and improved patient health outcomes; Business and Financial acumen; Continuous and team-based healing relationships that incorporate culture, values, and beliefs; Organized, evidence-based care; patient-centered interactions; Enhanced access; progression toward population based care management; State-of-the-art, results-linked, care; Intentional approach of practices to maximize the systematic engagement of patients and families; and Systematic efforts to reduce un-necessary diagnostic testing and procedures with little or no benefit. CMS may use this information collected through this RFI notice to test new payment and service delivery models.

On March 7, 2014 the Pharmacy HIT Collaborative submitted comments in response to the February 21, 2014, CMS Advance Notice of Methodological Changes for Calendar Year 2015 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter. The Collaborative’s comments pertains to medication therapy management (MTM) standards section, page 133, “Standards: We continue to encourage industry to develop and use standards for Health Information Technology (HIT) for MTM service documentation. We also encourage the industry to reach consensus on more robust definitions for MTM, CMRs, and drug therapy recommendations and resolutions for service delivery and performance measurement. Otherwise, CMS will work with the industry to convene Technical Expert Panels to develop additional standards and definitions which will be proposed in future rulemaking for adoption by all Part D sponsors.“ The Collaborative is supportive of developing standards for HIT for MTM service documentation. The Collaborative and its member organizations support the development of a private sector approach to develop these standards and look forward to working with CMS to build upon the work already under way.

On December 19, 2013, the Pharmacy HIT Collaborative submitted comments in response to the November 18, 2013, CMS letter Request for Comments – Standardized Format for Part D Medication Therapy Management Program Comprehensive Medication Review Summary. The Pharmacy HIT Collaborative is supportive of the revisions proposed for the standardized format. We also are supportive of CMS including a technical expert panel of long-term care (LTC) stakeholders in this review process to optimize the integration and effectiveness of the standardized format in LTC settings. The Pharmacy HIT Collaborative has been involved with CMS since the early development of the standardized format. We were pleased to see that CMS incorporated the majority of the Collaborative’s August 2011 recommendations into the initial standardized format implementation and that those recommends are remaining in the proposed revisions.

On February 28, 2013 the Pharmacy e-Health Information Technology Collaborative’s submitted comments to the Medication Therapy Management Section of the Advance Notice of Methodological Changes for CY 2014 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2014 Call Letter. The Pharmacy e-HIT Collaborative is supportive of the continued use of MTM services within the Part D drug program and would encourage CMS to expand MTM services to improve and promote coordination of care of Medicare beneficiaries. We agree that beneficiaries should be encouraged to complete their annual Comprehensive Medication Review (CMR) prior to their annual wellness visit and to take their standardized medication action plan and personal medication list from their CMR to their annual wellness visit or any medical encounter (primary care physician or specialist visit, hospital admission, etc.).

The Pharmacy e-HIT Collaborative supports the use of this summary in an electronic form as a valuable tool to share information across providers especially providers that have adopted electronic health records (EHR). We applaud CMS’ plans to include this message to beneficiaries beginning with the 2014 Medicare & You Handbook or other beneficiary communications. We are in support of encouraging Part D sponsors and MTM providers, including community pharmacists, to communicate this recommendation to beneficiaries when notifying beneficiaries of their enrollment in the MTM program and when offering or scheduling CMRs and to explore other opportunities to use MTM to better coordinate care with their pharmacists, including having a pharmacist-provided CMR after a transition in care or after a hospitalization. The Collaborative agrees and supports standardizing HIT for documentation of MTM services, including the use of SNOMED CT and National Council for Prescription Drug Programs (NCPDP)/Health Level 7 (HL7) MTM Templated CDA in a standardized format based on standard elements in databases and EHRs rather than manipulating free-form text documents.

On December 27, 2012 the Pharmacy e-HIT Collaborative submitted comments to CMS in response to request for information regarding Health Care Quality for Exchanges. As this process moves forward, the Collaborative urged CMS to consider the important role pharmacists play in achieving the clinical and functional objectives to meet meaningful use that results in improvement in patient care and outcomes.

On May 6, 2012, the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the Centers for Medicare and Medicaid Services (CMS) request for comments the “Medicare and Medicaid Programs; Electronic Health Record Incentive Program – Stage 2 Notice of Proposed Rulemaking” published in the Federal Register on March 7, 2012. The Collaborative recommends that CMS consider allowing pharmacists to become eligible professionals (EPs) in the Electronic Health Record (EHR) Incentive Program. The Collaborative is very supportive of the proposed measures and objectives for the EHR Incentive program; however, our concern is that the proposed measures and objectives will become unfunded mandates (these areas are noted throughout our comments below). Pharmacists are ineligible for EHR incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with EPs. Today, that exchange is not at an adequate level. Pharmacists have standards in place to meet these requirements. As implementation of Stage 2 moves forward, it should not create additional or financial burdens on pharmacists, such as becoming an unfunded mandate. Also as our comments indicate, allowing pharmacists the opportunity to become EPs and receive EHR incentives may lead to adoption of these EHR standards at a level that may be significant.

On August 1, 2011, the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the Centers for Medicare and Medicaid Services (CMS) request for comments regarding "Medicare Advantage, Medicare Part D and Medicare Fee For Service Consumer Assessment of Healthcare Providers and Systems Survey".

The Collaborative recommends that "data requirements" (the information or data that is required to be populated in fields of standardized formats) for medication therapy management (MTM) electronic transactions are incorporated into the "Standardized Format for the Comprehensive Medication Review Action Plan and Personal Medication List Summary". Furthermore, the Collaborative members' request clarification on printing formats and if CMS expects standardized forms to be printed in the specific format as presented in the draft or if there is flexibility in how pharmacies can print the forms utilizing their software systems. The Collaborative members' recommend that CMS consider flexibility in the format of the standardized forms and should allow an electronic media if available.

On March 25, 2011, the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the Centers for Medicare and Medicaid Services (CMS) request for comments regarding "Standardized Format for the Comprehensive Medication Review Action Plan and Summary".

The Collaborative recommends that data requirements for MTM electronic transactions are incorporated into the "Standardized Format for the Comprehensive Medication Review Action Plan and Summary". This would assure completion of the forms for the patient is driven off existing electronic data elements so that rekeying will not be necessary. This recommendation is supported through the American National Standards Institute (ANSI) Standard Development Organizations including National Council for Prescription Drug Programs (NCPDP), Accredited Standards Committee (ASC X12), and Health Level Seven (HL7) processes to assure Medication Therapy Management Services (MTMS) electronic standard transactions are developed. The Collaborative supports and works with these organizations to make certain data elements such as those in the proposed forms are populated from the "Pharmacist EHR" and or other types of interoperable electronic systems.

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HHS Comments

On October 4, 2013, the Pharmacy HIT Collaborative submitted comments to Health and Human Services (HHS) in response to their Request for Comments on the Draft National Action Plan for Adverse Drug Event Prevention. The Pharmacy HIT Collaborative is supportive of the continued use of electronic health information exchange across providers and patients, especially the integration of pharmacists in providing quality patient care and their role with regard to adverse drug event (ADE) prevention and the use of health information technology (HIT) to attain such. The Pharmacy HIT Collaborative advocates the meaningful use of HIT and the inclusion of pharmacists within a technology-enabled integrated health care system. The inclusion of pharmacy in the national action plan for ADE prevention may help in providing more robust information regarding ADE occurrences. Pharmacists are in a strong strategic position to advance ADE prevention.

On August 20, 2012 the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to respond to the Agency for Health Care Research and Quality Attention’s Request for Information on Quality Measurement Enabled by Health IT published in the Federal Register on July 20, 2012. The Collaborative recommends that pharmacists be included in the HIT quality measurement process so as to integrate pharmacy health information technology (HIT) into the national HIT infrastructure and to assure that pharmacists can connect to other health care providers through secure bidirectional communication. As recognized health care providers and HIT users, pharmacists play an important role in providing treatments and care to patients. In some settings, pharmacists are first-line-of-care providers, and as such, access to health information through the health information network is critical. As our responses to the questions posed by AHRQ demonstrate, the use of the national HIT infrastructure by pharmacists is critical to the integration of pharmacist-provided patient care services into the national HIT plan.

On May 6, 2012 the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to the “Request for Information on Prescription Medication Adherence” published in the Federal Register on April 5, 2012. Pharmacists play an important role in optimizing medication adherence, therapeutic outcomes and eliminating many of the issues that cause medication non-adherence. In their role, pharmacists promote safe, efficacious, cost-effective medication use to achieve definite outcomes through the responsible provision of drug therapy that improve a patient’s quality of life. Pharmacists are key resources that help bridge the gap between physicians and patients. Pharmacists can provide needed medication information and education to patients concerning their drug therapy that physicians and other health care providers may not have, and encourage and improve prescription medication adherence in patients. Additionally, the bidirectional exchange of clinical information with pharmacists, especially through electronic health records (EHRs), will help ensure prescription medication adherence.

On August 1, 2011, the Pharmacy e-Health Information Technology Collaborative (Collaborative) provided comments to Health and Human Services (HHS) request for comments regarding "HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act".

The Collaborative generally supports the goals of the Department of Health and Human Services (HHS) to allow individuals to receive information regarding uses and disclosures of protected health information to assist providing greater transparency regarding the uses and disclosures of information. However, the Collaborative is concerned that the NPRM is an overly burdensome requirement for covered entities. Specifically, the time and resources investment required to implement systems to track and monitor uses and disclosures of PHI, including for treatment, payment, and operations and to closely monitor uses and disclosures by business associates is costly relative to benefit. The Collaborative suggests that HHS withdraw the rule as proposed and work with stakeholders to develop a rule that is more consistent with the provisions implemented under HITECH.

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