Interoperability and Patient Access for Medicare Advantage Organization and Medicaid

Notice: This HHS-approved document has been submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display or published in the Federal Register. The document may vary slightly from the published document if minor editorial changes have been made during the OFR 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 Centers 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-P] RIN 0938-AT79 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule is 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 access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices CMS-9115-P 2 and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on [Insert date 60 days after date of publication in the Federal Register]. ADDRESSES: In commenting, please refer to file code CMS-9115-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the "Submit a comment" instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9115-P, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9115-P, CMS-9115-P 3 Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the "SUPPLEMENTARY INFORMATION" section. FOR FURTHER INFORMATION CONTACT: Alexandra Mugge, (410) 786-4457, for issues related to interoperability, CMS health IT strategy, technical standards and patient matching. Natalie Albright, (410) 786-1671, for issues related to Medicare Advantage. John Giles, (410) 786-1255, for issues related to Medicaid. Emily Pedneau, (301) 492-4448, for issues related to Qualified Health Plans. Meg Barry, (410) 786-1536, for issues related 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 data exchange. Daniel Riner, (410) 786-0237, for issues related to Physician Compare. Ashley Hain, (410) 786-7603, for issues related to hospital public reporting. Melissa Singer, (410) 786-0365, for issues related to provider directories. CAPT Scott Cooper, USPHS, (410) 786-9465, for issues related to hospital and critical access hospital conditions of participation. Lisa Bari, (410) 786-0087, for issues related to advancing interoperability in innovative models. Russell Hendel, (410) 786-0329, for issues related to the Collection of Information or the Regulation Impact Analysis sections. CMS-9115-P 4 SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. I. Background and Summary of Provisions A. Purpose This proposed rule is the first phase of proposed policies centrally focused on advancing interoperability and patient access to health information using the authority available to the Centers for Medicare & Medicaid Services (CMS). We believe this is an important step in advancing interoperability, putting patients at the center of their health care and ensuring they have access to their health information. We are committed to solving the issue of interoperability and achieving complete access to health information for patients in the United States (U.S.) health care system, and are taking an active approach to move participants in the health care market toward interoperability and the secure and timely exchange of health information by proposing and adopting policies for the Medicare and Medicaid programs, the Children’s Health Insurance Program (CHIP), and issuers of qualified health plans (QHPs). Throughout this proposed rule, we refer to terms such as patient, consumer, beneficiary, enrollee, and individual. We note that every reader of this proposed rule is a patient and has or will receive medical care at some point in their life. In this proposed rule, we use the term “patient” as an inclusive term, but because we have historically referred to patients using other terms in our regulations, we use specific terms as applicable in sections of this proposed rule to CMS-9115-P 5 refer to individuals covered under the health care programs that CMS administers and regulates. We also use terms such as payer, plan, and issuer in this proposed rule. Certain portions of this proposed rule are applicable to the Medicare Fee-for-Service (FFS) Program, the Medicaid FFS Program, the CHIP FFS program, Medicare Advantage (MA) Organizations, Medicaid Managed Care plans (managed care organizations (MCOs), prepaid inpatient health plans (PIHPs) and prepaid ambulatory health plans (PAHPs)), CHIP Managed Care entities (MCOs, PIHPs, and PAHPs), and QHP issuers in Federally-facilitated Exchanges (FFEs). We use the term “payer” as an inclusive term, but we use specific terms as applicable in sections of this proposed rule. B. Overview We are dedicated to enhancing and protecting the health and well-being of all Americans. One critical issue in the U.S. health care system is that people cannot easily access their complete 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. We believe patients should have the ability to move from health plan to health plan, provider to provider, and have both their clinical and administrative information travel with them throughout their journey. When a patient receives care from a new provider, a complete record of their health information should be readily available to that care provider, regardless of where or by who care was previously provided. When a patient is discharged from a hospital to a post- acute care (PAC) setting there should be no question as to how, when, or where their data will be exchanged. Likewise, when an enrollee changes health plans or ages into Medicare, the enrollee should be able to have their claims history and encounter data follow so that information is not lost. CMS-9115-P 6 For providers in clinical settings, health information technology (health IT) should be a resource, designed to make it faster and easier for providers to deliver high quality care, creating efficiencies and allowing them to access all available data for their patients. Health IT should not detract from the clinician-patient relationship, from the patient’s experience of care, or from the quality of work life for physicians, nurses, and other health care professionals. Through standards-based interoperability and exchange, health IT has the potential to be a resource and facilitator for efficient, safe, high-quality care for individuals and populations. All payers, including health plans, should have the ability to exchange data seamlessly with other payers for timely benefits coordination or transitions, and with providers to facilitate more coordinated and efficient care. Health plans are in a unique position to provide enrollees a complete picture of their claims and encounter data, allowing patients to piece together their own information that might otherwise be lost in disparate systems. This information can contribute to better informed decision making, helping to inform the patient’s choice of coverage options and care providers to more effectively manage their own health, care, and costs. We are committed to solving the issue of interoperability and patient access in the U.S. health care system while

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