Notice: This HHS-approved document will be submitted to ...

1 Notice: This HHS-approved document will be submitted to the Office of the F ederal Register (OFR) for publication and has not yet been placed on public display or published in the Federal Register. The document may vary s lightly from the published document if minor editorial changes hav e been made during the OF R review process. The document published in the Federal Register is the official HHS-approved document . [Billing Code: 4120-01-P] DEPARTMENT OF HEALTH AND HUMAN SERVICES Cen ters for Medicare & Medicaid Services 42 CFR Parts 406, 407, 422, 423, 431, 438, 457, 482, and 485 Office of the Secretary 45 CFR Part 156 [CMS-9115-F] RIN 0938-AT79 Medicare and Medicaid Programs; Patient Protection an d A ffordable Care Act; Interoperability and P atient Access for Medicare Advantage Organization an d Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qu alified Health Plans on t he Federally-facilitated Exchanges, and Health Care Providers AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

2 ACTION: Final rule. SUMMARY: This final rule is intended to move the health care ecosystem in the direction o f interoperability, a nd to s ignal our commitment to the vision set out in th e 21st century cures Act and Executive Order 13813 to improve the quality and accessibility of information that CMS -9115-F CPL 03/06/20 2 Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected health care providers and payers. DATES: These regulations a re e ffective on [Insert date 60 da ys a fter the date of pu blication in the Federal R egister]. FOR FURTHER INFORMATION CONTACT: Alexandra Mugge, (410) 786-4457, for issues related to interoperability, CMS health IT strategy, and t echn ical standards. Denise St. Clair, (410) 786-4599, for issues related API policies and related standards.

3 Natalie Albright, (410) 786-1671, for issues related to Medicare Advantage. Laura Snyder, (410) 786-3198, for issues relate d to Medicaid. Rebecca Zimmermann, (301) 492-4396, f or issues related to Qualified Health Plans. Meg Barry, (410) 786-1536, for issues relate d to CHIP. Thomas Novak, (202) 322-7235, for issues related to trust exchange networks and payer to payer coordination. Sharon Donovan, (410) 786-9187, for issues related to federal-state da ta exchange. Daniel Riner, (410) 786-0237, for issues relate d to Physician Compare. Ashley Hain, (410) 786-7603, for issues relate d to hospital public reporting. Melissa Singer, (410) 786-0365, for is s ues related to provider directories. CAPT Scott Cooper, USPHS, (410) 786-9465, for issue s related to ho spital and critical access hospital conditions o f pa rticipation. Russell Hendel, (410) 786-0329, for issues related to the Collection of Information or the Regulation Impact Analysis sections.

4 SUPPLEMENTARY INFORMATION: CMS -9115-F CPL 03/06/20 3 Table of Contents I. Background and Summary of ProvisionsA. PurposeB. OverviewC. Executive Order and MyHealthEDataD. Past EffortsE. Challenges and Barriers to InteroperabilityF. Summary of Major ProvisionsII. Technical Standards Related to Interoperability Provisions, and Analysis of and Responses toPublic Comments A. Technical Approach and StandardsB. Content and Vocabulary StandardsC. Application Programming Interface (API) StandardD. Updates to StandardsIII. Provisions of Patient Access Through APIs, and Analysis of and Responses to PublicComments A. Background on Medicare Blue ButtonB. Expanding the Availability of Health InformationC. Standards-based API Proposal for MA, Medicaid, CHIP, and QHP issuers on the FFEsIV. API Access to Published Provider Directory Data Provisions, and Analysis of andResponses to Public Comments A.

5 Interoperability Background and Use CasesB. Broad API Access to Provider Directory DataCMS -9115-F CPL 03/06/20 4 V. The Health Information Exchange and Care Coordination Across Payers: Establishing aCoordination of Care Transaction to Communicate Between Plans Provisions, and Analysis of and Responses to Public Comments VI. Care Coordination Through Trusted Exchange Networks: Trust Exchange NetworkRequirements for MA Plans, Medicaid Managed Care Plans, CHIP Managed Care Entities, and QHPs on the FFEs Provisions, and Analysis of and Responses to Public Comments VII. Improving the Medicare-Medicaid Dually Eligible Experience by Increasing the Frequencyof Federal-State Data Exchanges Provisions, and Analysis of and Responses to Public Comments A. Increasing the Frequency of Federal-State Data Exchanges for Dually EligibleIndividuals B. Request for Stakeholder InputVIII.

6 Information Blocking Background and Public Reporting Provisions, and Analysis of andResponses to Public Comments A. Information Blocking BackgroundB. Public Reporting and Prevention of Information Blocking on Physician CompareC. Public Reporting and Prevention of Information Blocking for Eligible Hospitals andCritical Access Hospitals (CAHs) IX. Provider Digital Contact Information Provisions, and Analysis of and Responses to PublicComments A. BackgroundB. Public Reporting of Missing Digital Contact InformationX. Conditions of P articipation for Hospitals and Critical Access Hospitals (CAHs) Provisions,and Analysis of and Responses to Public Comments CMS -9115-F CPL 03/06/20 5 A. BackgroundB. Provisions for Hospitals (42 CFR (d))C. Provisions for Psychiatric Hospitals (42 CFR (f))D. Provisions for CAHs (42 CFR (d))XI. Provisions of the Final RegulationsXII. Collection of Information RequirementsA.

7 BackgroundB. Wage EstimatesC. Information Collection Requirements (ICRs) Impact AnalysisA. Statement of NeedB. Overall ImpactC. Anticipated EffectsD. Alternatives ConsideredE. Accounting Statement and TableF. Regulatory Reform Analysis under EO 13771G. ConclusionRegulation Text I. Background and Summary of ProvisionsIn the March 4, 2019 Federal Register, we published the Medicare and Medicaid Programs; Patient Protection a nd A ffordable Care A ct; Interoperability and P a tient Access for Medicare Advantage Organization a nd Medicaid Managed C are Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the CMS -9115-F CPL 03/06/20 6 Federally-facilitated Exchanges and Health Care Providers proposed rule (84 FR 7610) (her einafter referred to a s the CMS Interoperability and P atient Access proposed rule ).

8 The proposed rule outlined our proposed policies that were intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st century cures Act and Executive Order 13813 to improve quality and accessibility of information that Americans need t o make informed health care decisions, including data about health care prices and out comes, w hile minimizing reporting burdens on affected health care providers and paye rs. We solicited public comments on t he CMS Interoperability an d Patient Access proposed rule. In this final rule, we address those public comments and outline our final policies in the re spective sections of t his r ule. A. P urposeThis final rule is the f irs t phase of policies centrally focused on a dva ncing interoperability and pa tie nt access to health information us ing the a ut hority ava ilable to the Centers for Medicare & Medicaid Services (CMS).

9 We believe this is an important st e p in advancing interoperability, putting patients at the center of t heir healt h care, and ensuring they have a ccess to the ir health information. W e a re committed to working w ith s ta keholders to solve the issue of interoperability and getting patients access to information about their health care, and we are taking an active approach to move participants in the health care market toward interoperability and the secure and timely exchange of healt h information by adopting policies for the Medicare and Me dicaid programs, the Children s Health Insurance Program (CHIP), and qualified health pla n (QH P) issuers on the ind ividual market Federally-facilitated Exchanges (FFEs). For purposes of this rule, references to QHP i ssue rs on the FFEs excludes issuers offering only stand-alone dental plans (SADPs), unless otherwise noted for a specific proposed CMS -9115-F CPL 03/06/20 7 or finalized policy.

10 Likewise, we are also excluding QHP issuers only offering QHPs in the Federally-facilitated Small Business Health Options Program Exchanges (FF- SHOPs) from the provisions of this rule and so, for purposes of this rule references to QHP issuers on the FFEs excludes issuers offering QHPs only on the FF-SHOPs. We note that, in this final rule, FFEs include FFEs in states that perform plan management functions. State-Based Exchanges on the Federal Platform (SBE-FPs) are not FFEs, even though consumers in these states enroll in coverage through , and QHP issuers in SBE-FPs are not subject to the requirements in this rule. B. OverviewWe are dedicated to enhancing and protecting the health and well-being of all Americans. One critical issue in the health care system is that people cannot easily access their health information in interoperable forms. Patients and the health care providers caring for them are often presented with an incomplete picture of their health and care as pieces of their information are stored in various, unconnected systems and do not accompany the patient to every care setting.