Federal Register/Vol. 85, No. 85/Friday, May 1
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25510 Federal Register / Vol. 85, No. 85 / Friday, May 1, 2020 / Rules and Regulations DEPARTMENT OF HEALTH AND Sharon Donovan, (410) 786–9187, for B. Request for Stakeholder Input HUMAN SERVICES issues related to federal-state data VIII. Information Blocking Background and exchange. Public Reporting Provisions, and Centers for Medicare & Medicaid Daniel Riner, (410) 786–0237, for Analysis of and Responses to Public Services issues related to Physician Compare. Comments Ashley Hain, (410) 786–7603, for A. Information Blocking Background B. Public Reporting and Prevention of 42 CFR Parts 406, 407, 422, 423, 431, issues related to hospital public Information Blocking on Physician 438, 457, 482, and 485 reporting. Compare Melissa Singer, (410) 786–0365, for C. Public Reporting and Prevention of Office of the Secretary issues related to provider directories. Information Blocking for Eligible CAPT Scott Cooper, USPHS, (410) Hospitals and Critical Access Hospitals 45 CFR Part 156 786–9465, for issues related to hospital (CAHs) and critical access hospital conditions IX. Provider Digital Contact Information [CMS–9115–F] of participation. Provisions, and Analysis of and Russell Hendel, (410) 786–0329, for Responses to Public Comments RIN 0938–AT79 issues related to the Collection of A. Background Information or the Regulation Impact B. Public Reporting of Missing Digital Medicare and Medicaid Programs; Contact Information Patient Protection and Affordable Care Analysis sections. X. Conditions of Participation for Hospitals Act; Interoperability and Patient SUPPLEMENTARY INFORMATION: and Critical Access Hospitals (CAHs) Access for Medicare Advantage Table of Contents Provisions, and Analysis of and Organization and Medicaid Managed Responses to Public Comments Care Plans, State Medicaid Agencies, I. Background and Summary of Provisions A. Background A. Purpose B. Provisions for Hospitals (42 CFR CHIP Agencies and CHIP Managed B. Overview 482.24(d)) Care Entities, Issuers of Qualified C. Executive Order and MyHealthEData C. Provisions for Psychiatric Hospitals (42 Health Plans on the Federally- D. Past Efforts CFR 482.61(f)) Facilitated Exchanges, and Health Care E. Challenges and Barriers to D. Provisions for CAHs (42 CFR Providers Interoperability 485.638(d)) F. Summary of Major Provisions XI. Provisions of the Final Regulations AGENCY: Centers for Medicare & II. Technical Standards Related to XII. Collection of Information Requirements Medicaid Services (CMS), HHS. Interoperability Provisions, and Analysis A. Background ACTION: Final rule. of and Responses to Public Comments B. Wage Estimates A. Technical Approach and Standards C. Information Collection Requirements SUMMARY: This final rule is intended to B. Content and Vocabulary Standards (ICRs) move the health care ecosystem in the C. Application Programming Interface XIII. Regulatory Impact Analysis (API) Standard direction of interoperability, and to A. Statement of Need D. Updates to Standards B. Overall Impact signal our commitment to the vision set III. Provisions of Patient Access Through C. Anticipated Effects out in the 21st Century Cures Act and APIs, and Analysis of and Responses to D. Alternatives Considered Executive Order 13813 to improve the Public Comments E. Accounting Statement and Table quality and accessibility of information A. Background on Medicare Blue Button F. Regulatory Reform Analysis Under E.O. that Americans need to make informed B. Expanding the Availability of Health 13771 health care decisions, including data Information G. Conclusion about health care prices and outcomes, C. Standards-based API Proposal for MA, Regulation Text Medicaid, CHIP, and QHP Issuers on the while minimizing reporting burdens on FFEs I. Background and Summary of affected health care providers and IV. API Access to Published Provider Provisions payers. Directory Data Provisions, and Analysis In the March 4, 2019 Federal Register, of and Responses to Public Comments DATES: These regulations are effective we published the ‘‘Medicare and on June 30, 2020. A. Interoperability Background and Use Cases Medicaid Programs; Patient Protection FOR FURTHER INFORMATION CONTACT: B. Broad API Access to Provider Directory and Affordable Care Act; Alexandra Mugge, (410) 786–4457, for Data Interoperability and Patient Access for issues related to interoperability, CMS V. The Health Information Exchange and Medicare Advantage Organization and health IT strategy, and technical Care Coordination Across Payers: Medicaid Managed Care Plans, State standards. Establishing a Coordination of Care Medicaid Agencies, CHIP Agencies and Denise St. Clair, (410) 786–4599, for Transaction To Communicate Between CHIP Managed Care Entities, Issuers of issues related API policies and related Plans Provisions, and Analysis of and Qualified Health Plans on the Federally- Responses to Public Comments standards. VI. Care Coordination Through Trusted facilitated Exchanges and Health Care Natalie Albright, (410) 786–1671, for Exchange Networks: Trust Exchange Providers’’ proposed rule (84 FR 7610) issues related to Medicare Advantage. Network Requirements for MA Plans, (hereinafter referred to as the ‘‘CMS Laura Snyder, (410) 786–3198, for Medicaid Managed Care Plans, CHIP Interoperability and Patient Access issues related to Medicaid. Managed Care Entities, and QHPs on the proposed rule’’). The proposed rule Rebecca Zimmermann, (301) 492– FFEs Provisions, and Analysis of and outlined our proposed policies that 4396, for issues related to Qualified Responses to Public Comments were intended to move the health care Health Plans. VII. Improving the Medicare-Medicaid Dually ecosystem in the direction of Meg Barry, (410) 786–1536, for issues Eligible Experience by Increasing the interoperability, and to signal our Frequency of Federal-State Data related to CHIP. Exchanges Provisions, and Analysis of commitment to the vision set out in the Thomas Novak, (202) 322–7235, for and Responses to Public Comments 21st Century Cures Act and Executive issues related to trust exchange A. Increasing the Frequency of Federal- Order 13813 to improve quality and networks and payer to payer State Data Exchanges for Dually Eligible accessibility of information that coordination. Individuals Americans need to make informed VerDate Sep<11>2014 08:09 May 01, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\01MYR2.SGM 01MYR2 Federal Register / Vol. 85, No. 85 / Friday, May 1, 2020 / Rules and Regulations 25511 health care decisions, including data caring for them are often presented with patient’s health, providing insights into about health care prices and outcomes, an incomplete picture of their health everything from the frequency and types while minimizing reporting burdens on and care as pieces of their information of care provided and for what reason, affected health care providers and are stored in various, unconnected medication history and adherence, and payers. We solicited public comments systems and do not accompany the the evolution and adherence to a care on the CMS Interoperability and Patient patient to every care setting. Although plan. This information can empower Access proposed rule. In this final rule, more than 95 percent of hospitals 1 and patients to make better decisions and we address those public comments and 75 percent of office-based clinicians 2 inform providers to support better outline our final policies in the are utilizing certified health IT, health outcomes. respective sections of this rule. challenges remain in creating a For providers in clinical and comprehensive, longitudinal view of a community settings, health information A. Purpose patient’s health history.345 This siloed technology (health IT) should be a This final rule is the first phase of nature of health care data prevents resource, enabling providers to deliver policies centrally focused on advancing physicians, pharmaceutical companies, high quality care, creating efficiencies interoperability and patient access to manufacturers, and payers from and allowing them to access all payer health information using the authority accessing and interpreting important and provider data for their patients. available to the Centers for Medicare & data sets, instead, encouraging each Therefore, health IT should not detract Medicaid Services (CMS). We believe group to make decisions based upon a from the clinician-patient relationship, this is an important step in advancing part of the information rather than the from the patient’s experience of care, or interoperability, putting patients at the whole. Without an enforced standard of from the quality of work life for center of their health care, and ensuring interoperability, data exchanges are physicians, nurses, other health care they have access to their health often complicated and time-consuming. professionals, and social service information. We are committed to We believe patients should have the providers. Through standards-based working with stakeholders to solve the ability to move from payer to payer, interoperability and information issue of interoperability and getting provider to provider, and have both exchange, health IT has the potential to patients access to information about their clinical and administrative facilitate efficient, safe, high-quality their health care, and we are taking an information travel with them care for individuals and populations. active approach to move participants in throughout their journey. When a All payers should have the ability to the