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 October 24, 2016, the Pharmacy HIT Collaborative (Collaborative), submitted comments regarding the proposed final 2017 Interoperability Standards Advisory request for information. As noted in our submitted comments on the Interoperability Standards Advisory tables, it is vitally important that pharmacists’ access to the proposed interoperability elements not be limited.  Pharmacists, as health care providers, need the ability to query documents within/outside a specific health information exchange domain and clinical health information, as well as medication and immunization sharing.  Pharmacists need to know the indications on medications relating to ICD-10 and SNOMED-CT.   The Collaborative has been working with several pharmacy organizations and other groups regarding the use of a structured coding system – SNOMED-CT – particularly for medication therapy management (MTM) services clinical documentation by pharmacists including Pharmacist eCare Plan Version 1.0: Guidance on the Use of the HL7 CDA Consolidated Templates for Clinical Notes R2.1 Care Plan http://www.ncpdp.org/NCPDP/media/pdf/Pharmacist-eCare-Plan.pdf.

HIT Policy and Standards Committee July 27, 2016 - <Collaborative Executive Director's Public Comments>

On June 3, 2016 the Pharmacy Health Information Technology Collaborative (Collaborative), responded  to the Office of National Coordinator for HIT (ONC's) request for information regarding assessing Interoperability for Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Collaborative and its member organizations support interoperability and certification of health information technology and electronic health records (EHRs). The Collaborative has been involved with the ONC and the Center for Medicaid and Medicare Services since the early development of the standards and criteria as they apply to the Meaningful Use EHR Incentive Program and their affect on non-eligible pharmacist health care providers. The Collaborative also supports and provided numerous comments on the ONC’s Connecting Health and Care for the Nations: A Shared Nationwide Interoperability Roadmap. Although pharmacists are ineligible for EHR incentives, pharmacists provide patient-centered care and services to Medicaid and Medicare, and they are part of many integrated health care teams comprising eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs). The exchange of information through interoperable health IT and certified EHR is essential to pharmacists. As discussed in the attached document, measures under consideration that are of particular importance to pharmacists are those concerning bi-directional exchange of electronic prescriptions (e.g. prescription fill status, change, cancel and indication information), transitions of care including sharing of standard electronic structured documents (e.g. C-CDA eCare Plans) and the reconciliation of medications, medication allergies and problem lists. Pharmacists are the most readily accessible health care professionals, and they are in a unique position in the health care continuum to assist in improving quality in all EHR quality measure domains, as well as improving the quality of patient outcomes, especially for those patients utilizing medication management services. Many quality measures required currently by CMS focus on medication use and will be influenced by pharmacists.

On May 2, 2016, the Pharmacy HIT Collaborative (Collaborative) submitted a letter and comments to ONC Health IT Certification Program: Enhanced Oversight and Accountability rule. The Collaborative and its member organizations are supportive of continued certification criteria and standards for health IT and electronic health record (EHR). In general, the Collaborative supports the proposed rule. There is one part of the preamble, however, in which we have concern.   As we note in the general comments section, our concern is with the potential cost estimates to health providers if a certification termination occurs, especially with regard to health care providers, such as pharmacists, who are not eligible to participate in the EHR Incentive Program. The proposal provides no remedies. Although pharmacists are ineligible to participate in the EHR Incentive Programs, they are part of integrated health care teams that include eligible professionals (EPs), critical access hospitals (CAHs), and eligible hospitals, and they are users of the same certified health IT. Without remedies, the costs associated with a termination would be a financial burden.

On March 21, 2016, the membership of the Pharmacy Health Information Technology Collaborative (Collaborative), submitted a comment letter and table regarding the proposed final 2016 Interoperability Standards Advisory. The Collaborative has been involved with the federal agencies, including the Office of the National Coordinator (ONC), developing the national health information technology (HIT) framework since 2010. The Collaborative is supportive of the proposed standards for clinical health IT interoperability purposes. Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings. Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating HL7, SNOMED CT, LOINC, RxNorm, and NCPDP SCRIPT, and NCPDP Real Time Formulary and Benefits (currently under development). The Collaborative supports use of these particular standards which are important to pharmacists for allergy reactions, immunization historical and administered, immunization registry reporting, medications, medication allergies, patient problems, smoking status, reporting to public health agencies, clinical decision support services/knowledge artifacts, drug formulary checking, and electronic prescribing (including new versions).

On February 1, 2016, the Pharmacy HIT Collaborative submitted comments for the Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures under CMS Programs. The Collaborative is supportive of testing and re-certifying health IT modules (including CEHRT) in accordance with ONC Health IT Certification Program requirements. Although pharmacists are ineligible for electronic health record (EHR) incentives, pharmacists provide patient-centered care and services and are part of many integrated health care teams comprising eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) that are directly affected by reporting quality measures under CMS programs. The Collaborative believes that periodically requiring additional testing and re-certifying existing certified EHR products with the annual updates provided would improve standardization and encourage health IT developers and vendors to create products that go beyond minimum clinical quality measures (CQMs) thresholds. This could lead providers toward more detailed and better reporting. As standards for electronically representing CQMs continue to evolve, retesting certified health IT modules periodically may also ensure that CQMs are being represented and calculated accurately.

On December 15, 2015, the Pharmacy Health Information Technology Collaborative (Collaborative) submitted further comments on specific sections of the final rule – Medicare and Medicaid Program; Electronic Health Record Incentive Program – Stage 3 and Modification to Meaningful Use in 2015 through 2017. The Collaborative is supportive of the proposed modifications for transitioning to the Merit-Based Incentive Payment System (MIPS) starting in 2018, as established by the enactment of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Collaborative supports value-based payment systems. Although pharmacists are ineligible for electronic health record (EHR) incentives, they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with eligible professionals (EPs).  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. As we understand it, CMS will be issuing proposed rule-making for the MIPS by mid-2016 and that CMS is seeking additional comments on certain sections of this EHR Incentive Program final rule for consideration in developing the proposed MIPS rules. In addition to the sections open for comment, the Collaborative has one recommendation that is not addressed by these specific sections but is part of a change to the EHR incentive program authorized by MACRA that concerns pharmacists.

On November 6, 2015, the Pharmacy HIT Collaborative submitted comments regarding the proposed 2016 Interoperability Standards Advisory. The Collaborative is supportive of the proposed standards for clinical health IT interoperability purposes. Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings.  Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating HL7, SNOMED CT, LOINC, RxNorm, and NCPDP SCRIPT, and NCPDP Real Time Formulary and Benefits (currently under development).  The Collaborative supports use of these particular standards which are important to pharmacists for allergy reactions, immunization historical and administered, immunization registry reporting, medications, medication allergies, patient problems, smoking status, reporting to public health agencies, clinical decision support services/knowledge artifacts, drug formulary checking, and electronic prescribing (including new versions). As noted in our attached comments on the Interoperability Standards Advisory tables, it is vitally important that pharmacists’ access to the proposed interoperability elements not be limited.  Pharmacists, as health care providers need the ability to query documents within/outside a specific health information exchange domain and clinical health information, as well as medication and immunization sharing.  Pharmacists need to know the indications on medications relating to ICD-10 and SNOMED-CT. 

HIT Policy Committee June 30, 2015 - Collaborative Executive Director's Public Comments

On June 15, 2015, Pharmacy HIT Collaborative submitted comments in response to ONC’s comment request for Medicare and Medicaid Program; Electronic Health Record Incentive Program – Modification to Meaningful Use in 2015 through 2017. The Collaborative is supportive of the proposed modifications.  Although pharmacists are ineligible for electronic health record (EHR) incentives, they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with eligible professionals (EPs).  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.

On May 29, 2015, the Pharmacy Health Information Technology Collaborative (Collaborative), submitted a letter and comments in response to the Office of the National Coordinator (ONC) for Health Information Technology’s 2015 Edition Health IT Certification Proposed Rule. The Collaborative and its member organizations are supportive of continued certification criteria and standards for health IT and EHR. The Collaborative has been involved with the ONC and the Center for Medicaid and Medicare Services since the early development of these standards and criteria as they apply to the Meaningful Use EHR Incentive Program and their effect on non-eligible pharmacist health care providers. Although pharmacists are not eligible for EHR incentives, they will need to exchange information with secure and certified EHR systems to connect to and ensure needed bidirectional communication with eligible providers. 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.

On May 1, 2015 the membership of the Pharmacy HIT Collaborative submitted comments regarding the proposed 2015 Interoperability Standards Advisory (Open Draft). The Collaborative has been involved with the federal agencies, including the Office of the National Coordinator (ONC), developing the national health information technology (HIT) framework since 2010.  The Collaborative is supportive of the proposed initial list of standards for clinical health IT interoperability purposes. Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings.  Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating HL7, SNOMED CT, RxNorm, and NCPDP SCRIPT.  As outlined in the initial lists indicating these specific standards, those of particular importance to pharmacists include:  allergy reactions, immunization historical and administered, immunization registry reporting, medications, medication allergies, patient problems, smoking status, reporting to public health agencies, clinical decision support services/knowledge artifacts, drug formulary checking, and electronic prescribing. 

On April 3, 2015 the Pharmacy Health Information Technology Collaborative submitted comments regarding the proposed Connecting Health and Care for the Nation:  A Shared Nationwide Interoperability Roadmap Draft Version 1.0. The Collaborative was pleased to see and appreciates the Office of the National Coordinator (ONC) recognizing pharmacists numerous times in various sections of the roadmap.  These include specifically listing pharmacists as health care providers and users of health information exchanges; referencing the NCPDP-HL7 Pharmacist/Pharmacy Provider Functional Profile Task Group; and acknowledging patient-centered care services, such as comprehensive medication management (CMM) and medication therapy management (MTM), provided by pharmacists. Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings.  Pharmacists are in a strategic position to help improve patient safety and patient privacy, especially, through HIT.

HIT Standards Committee S&I Task Group February 27, 2015 - Collaborative Executive Director's Public Comments

On February 6, 2015 the Pharmacy HIT Collaborative responded to ONC’s request for comments on the Federal Health IT Strategic Plan 2015-2020. The Collaborative is supportive of strategies and recommendations that improve the secure use of health information through safely designed and implemented HIT systems, while maintaining and protecting patient privacy. As health care providers, pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings. Pharmacists are in a strategic position to help improve usage, patient safety, and protect patient privacy through HIT.

On November 6, 2014, the Pharmacy HIT Collaborative submitted comments in response to ONC’s October 8, 2014 Request for 2014 Edition Release 2 EHR Certification Test Procedures. The Collaborative supports the proposed test procedures for the 11-certification criterion targeted and the proposed changes in the 2014 Edition Release 2 described in the test procedures documents. The Collaborative has been involved with the Office of the National Coordinator for Health IT (ONC) developing the national health information technology (HIT) framework since 2010.  

HIT Policy Committee June 10, 2014 - Collaborative Executive Director's Public Comments

On April 28, 2014 the membership of the Pharmacy HIT Collaborative submitted comments to ONC in response to Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements federal register proposed rule posted February 26, 2014. The Pharmacy HIT Collaborative and its member organizations are supportive of continued certification criteria and standards for HIT and EHR. The Collaborative has been involved with the ONC and the Center for Medicaid and Medicare Services since the early development of these standards and criteria as they apply to the Meaningful Use EHR Incentive Program and their affect on non-eligible pharmacist health care providers.

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 June 27, 2016, the Pharmacy Health Information Technology Collaborative (Collaborative) submitted comments for the proposed rule CMS-5517-P: Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. The Collaborative and its member organizations are supportive of continued certification criteria and standards for health IT and EHR. The Collaborative has been involved with the ONC and the Center for Medicaid and Medicare Services since the early development of these standards and criteria as they apply to the Meaningful Use EHR Incentive Program and their effect on non-eligible pharmacist health care providers. Although pharmacists are ineligible for EHR incentives and MIPS at this time, pharmacists provide patient-centered care and services to Medicaid and Medicare, and they are part of many integrated health care teams comprising eligible professionals (EPs), eligible hospitals, critical access hospitals (CAHs), and what will now be the new eligible clinicians. The exchange of information through interoperable health IT and certified EHR is essential to pharmacists.

On April 26, 2016, the Pharmacy HIT Collaborative (Collaborative) submitted a comment letter to the Centers Medicare & Medicaid Services (CMS) Innovation Center (CMMI) on their request for comments Medicare Part D Enhanced Medication Therapy Management (MTM) Model; Enhanced MTM Model Encounter Data Specification Plan.  The Collaborative strongly supports the Centers for Medicare & Medicaid’s (CMS) proposal for using the value sets of SNOMED CT® for the Medicare Part D enhanced MTM model. SNOMED CT has the potential to create benefit for the patient and the greater health care environment.  Adoption of the use of SNOMED CT by Medicare Part D is critical to the expansion of MTM documentation. This terminology permits the capturing of clinical information and permits the codifying of patient care encounters in the electronic health record (EHR). Coupled with classification systems, such as RxNorm for medication identification, incorporation of SNOMED CT leads to interoperability of health information systems, a critical element of the national framework for health IT that is being developed and actively supported by the Collaborative.

On March 4, 2016, the Pharmacy HIT Collaborative submitted comments for the Advance Notice of Methodological Changes for Calendar Year (CY) 2017 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2017 Call Letter. Our comments pertain to the call letter’s Part D Reporting Requirements for MTM. The Collaborative has been working with several pharmacy organizations and other groups regarding the use of a structured coding system – SNOMED CT – for medication therapy management (MTM) services clinical documentation by pharmacists. We believe that the consistent use of structured universal codes is critical to the expansion of documentation of MTM services and support the use and implementation of SNOMED CT codes for these services.

On January 4, 2016, the Pharmacy HIT Collaborative submitted comments in response to CMS request for information on the proposed rule – CMS-3311-P – Medicare and Medicaid Program; Revisions to Requirements for Discharge Planning Hospitals, Critical Access Hospitals, and Home Health Agencies. The Collaborative is supportive of the proposed modifications for the discharge planning process from acute care hospitals and post-acute care (PAC) settings for transitioning care to a patient’s home (with or without PAC services), skilled nursing facility, nursing home, long term care hospital, rehabilitation hospital or unit, assisted living center, or other health care settings.  Pharmacists are already providing a critical role in discharge planning. Therefore the Collaborative recommends that the proposed rule explicitly indicate that pharmacists be included in the discharge planning process. Pharmacists play important roles at points of transition of care, especially, in post-acute and long-term care; by assuring orders created by eligible professionals (EPs) are correct, and reconciling medications.  These roles require pharmacists to have access to current problem lists at the points of transition to match medications for patients to use. This is particularly important for medication therapy management (MTM) services pharmacists provide under Medicare Part D.  

On November 17, 2015, the Pharmacy HIT Collaborative submitted comments in response to CMS request for information regarding implementation of the "Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive for Participation in Eligible Alternative Payment Models”. The Collaborative recommends for the benefit of patient care and system efficiencies that pharmacists be included in the list of MIPS eligible professionals (EP). As we understand, the HHS Secretary has been given discretion to specify additional EPs as that term is defined in Section 1848(k)(3)(B) of the Act.  In reviewing “Section A. The Merit-based Incentive Payment System” of this RFI, we note that pharmacists are not included as additional EPs. While it appears that the Medicare Access and CHIP Reauthorization Act of 2015 does not specifically list pharmacists as a health care professional eligible for EP designation, we appreciate CMS’s support and use of regulatory discretion in helping increase patients access to health care through pharmacist-provided care.

On May 29, 2015, the Pharmacy Health Information Technology Collaborative (Collaborative), submitted comments in response the Centers for Medicare & Medicaid Services (CMS) request for comment for Medicare and Medicaid Program; Electronic Health Record Incentive Program – Stage 3. The Collaborative is supportive of the proposed measures and objectives for Stage 3. Although pharmacists are ineligible for electronic health record (EHR) incentives, they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with 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.

On February 6, 2015 the Pharmacy HIT Collaborative responded to CMS’s request for comments on Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-P). Pharmacists are part of the integrated team approach of health care providers. Although not all pharmacists are partners with ACOs, they still work with health care providers (e.g., physicians) who are part of ACOs. Pharmacists also provide patient-centered care services to the ACO’s beneficiaries, even though the pharmacist may not be part of the ACO. In this regard, it is vitally important that EHRs be a required part of ACOs. Requiring such would help greatly in connecting pharmacists to health care providers in ACOs. Pharmacists are demonstrated meaningful users of EHRs.  

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 April 11, 2016, the Pharmacy Health Information Technology Collaborative, submitted comments on SAMHSA-4162-20 – Confidentiality of Substance Use Disorder Patient Records. Pharmacists provide patient-centered care and services, maintain secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings, which may include Part 2 programs for substance use disorder. The Collaborative supports the objective of maintaining confidentiality of substance use disorder patient records. In reviewing the proposed rule, however, we note that requiring the use of secure, certified health IT, networks, and devices, especially for the transmission of patient records, does not appear to be included in the proposed provisions. We believe this should be a requirement for safeguarding patient records. Cybercrime and threats are a fast-growing challenge. Also requiring the use of secure health IT for the transport of patient records would bring the proposed rule into alignment with the Office of the National Coordinator’s Federal Health IT Strategic Plan 2015-2020 and Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap, as well as the certified health IT requirements for the Meaningful Use Electronic Health Record Incentive Program. The Collaborative has been involved with the federal agencies developing the national health IT framework since 2010. The Collaborative is supportive of recommendations to improve the safety of health IT through coordinated governance and safely designed and implemented systems, while maintaining and protecting patient privacy.

On March 23, 2015, the Pharmacy HIT Collaborative submitted comments regarding the National Vaccine Program Office’s (NVPO) draft report, National Adult Immunization Plan. The Collaborative is supportive of the plan’s overall objective of achieving higher vaccination rates of adults across all population groups for the prevention of infectious diseases. Our comments are focused on the plan’s goals, objectives and strategies related to health information technology. 

On March 12, 2015, the Pharmacy HIT Collaborative submitted comments in response the request for information: Soliciting Input into the Deliberations of the Advisory Committee to the NIH Director (ACD) Working Group on the National Library of Medicine (NLM). The Collaborative is supportive of the NLM and its role as an international leader in biomedical and health information.   As health care providers, pharmacists provide patient-centered care and services, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings utilizing the resources maintained and provided by the NLM.  

On August 12, 2014, the Pharmacy HIT Collaborative submitted comments to the U.S. Senate Finance Committee’s request for comments concerning the availability and utility of health care-related data.

On June 12, 2014, the Pharmacy HIT Collaborative submitted comments in response to the April 16, 2014, Proposed Strategy and Recommendations for a Risk-Based Framework for Food and Drug Administration Safety and Innovation Act Health Information Technology; Request for Comments. The Collaborative has been involved with the agencies developing the national HIT framework since 2010.  The Collaborative is supportive of the proposed strategy and recommendations to improve the safety of HIT through safely designed and implemented systems.  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 other health care providers and patients in various practice settings.  Pharmacists are in a strategic position to help improve patient safety, especially, through HIT.

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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