Advancing Interoperability and Health Information Exchange, 14793-14797 [2013-05266]

Download as PDF Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101) effective on the date shown. Office of the Secretary License No.: 017269N. Name: Fastmark Corporation. Address: 7206 NW 84th Avenue, Medley, FL 33166. Date Reissued: January 22, 2013. Centers for Medicare & Medicaid Services [CMS–0038–NC] Advancing Interoperability and Health Information Exchange Vern W. Hill, Director, Bureau of Certification and Licensing. Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice with comment; Request for Information. AGENCY: [FR Doc. 2013–05314 Filed 3–6–13; 8:45 am] BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Rescission of Order of Revocation The Commission gives notice that it has rescinded its Order revoking the following license pursuant to section 40901 of the Shipping Act of 1984 (46 U.S.C. 40101). License No.: 008504N. Name: Hyun Dae Trucking Co., Inc. Address: 3022 S. Western Avenue, Los Angeles, CA 90018. Order Published: January 25, 2013 (Volume 78, No. 17, Pg. 5440). Vern W. Hill, Director, Bureau of Certification and Licensing. [FR Doc. 2013–05315 Filed 3–6–13; 8:45 am] BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Revocations emcdonald on DSK67QTVN1PROD with NOTICES The Commission gives notice that the following Ocean Transportation Intermediary license has been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101) effective on the date shown. License No.: 021062F. Name: International Trade Compliance Group, LLC. Address: 101 North Riverside Drive, Suite 203, Pompano Beach, FL 33062. Date Revoked: February 20, 2013. Reason: Voluntary Surrender of License. Vern W. Hill, Director, Bureau of Certification and Licensing. [FR Doc. 2013–05311 Filed 3–6–13; 8:45 am] BILLING CODE 6730–01–P VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: HHS seeks input on a series of potential policy and programmatic changes to accelerate electronic health information exchange across providers, as well as new ideas that would be both effective and feasible to implement. To further accelerate and advance interoperability and health information exchange beyond what is currently being done through ONC programs and the EHR Incentive Program, HHS is considering a number of policy levers using existing authorities and programs. DATES: To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on April 22, 2013. ADDRESSES: You may submit comments identified by any of the following methods below (please do not submit duplicate comments). Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. • Federal eRulemaking Portal: Follow the instructions for submitting comments. Attachments should be in Microsoft Word or Excel, Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov. • Regular, Express, or Overnight Mail: Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: Interoperability RFI, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201. Please submit one original and two copies. • Hand Delivery or Courier: Office of the National Coordinator for Health Information Technology, Attention: Interoperability RFI, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201. Please submit one original PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 14793 and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.) Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. Please do not include anything in your comment submission that you do not wish to share with the general public. Such information includes, but is not limited to: A person’s social security number; date of birth; driver’s license number; state identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered to be proprietary. We will post all comments received before the close of the comment period at http:// www.regulations.gov. Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov or the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201 (call ahead to the contact listed below to arrange for inspection). FOR FURTHER INFORMATION CONTACT: • Kelly Cronin, Health Care Reform Coordinator; or • Steven Posnack, Director, Federal Policy Division Office of the National Coordinator for Health Information Technology, 202– 690–7151. SUPPLEMENTARY INFORMATION: I. Background Since enactment of the Health Information Technology for Clinical and Economic Health Act as part of the American Recovery and Reinvestment Act, adoption and use of electronic health records in the United States has dramatically increased. Adoption of EHRs that met the criteria for a basic EHR system by office-based physicians grew by over 80% between 2009 and 2012, from 22% in 2009 to 40% in 2012.1 2 Among non-federal acute care 1 Hsiao CJ, Hing E. Use and characteristics of electronic health record systems among office-based E:\FR\FM\07MRN1.SGM Continued 07MRN1 14794 Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES hospitals, adoption of at least a basic EHR system has increased by over 260% since 2009, from 12% to 44%.3 4 Since 2009, there has been strong and steady growth in adoption of EHR technology to meet Meaningful Use objectives to improve quality, safety and efficiency. Adoption of many of the computerized functionalities associated with Meaningful Use has substantially increased among both office-based physicians as well as hospitals.5 6 For example, physician adoption of five core Meaningful Use functionalities— ranging from e-prescribing to clinical decision support—has grown by at least 66% since HITECH in 2009. As part of stage 2 rulemaking HHS has taken major steps to expand the functionality and utility of EHRs to providers and patients. We seek to build on that work by engaging other policy areas within HHS jurisdiction to promote routine sharing of information among health care providers across settings of care to support care coordination and delivery system reform. We also recognize that economic and regulatory barriers may impair the development of a patient centered, information rich, high performance health care system where a persons’ health information follows them wherever they access health care services. The Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs and Office of the National Coordinator (ONC) for Health physician practices: United States, 2001–2012. NCHS data brief, no 111. Hyattsville, MD: National Center for Health Statistics. 2012. 2 A basic EHR system for office-based practices includes the following functionalities: Patient history and demographics, patient problem lists, physician clinical notes, comprehensive list of patients’ medications and allergies, computerized orders for prescriptions, and ability to view laboratory and imaging results electronically. Note that functionalities associated with basic EHR differ from functionalities required for meaningful use. 3 ONC analysis of data from the 2011 American Hospital Association Survey Information Technology Supplement. Data brief forthcoming. 4 A basic EHR system for hospitals includes the following functionalities: Patient history and demographics, patient problem lists, physician clinical notes, nursing assessments, comprehensive list of patients’ medications and allergies, discharge summaries, computerized orders for prescriptions, and the ability to view diagnostic test results, laboratory reports and radiology reports electronically. Note that functionalities associated with basic EHR differ from functionalities required for meaningful use. 5 King J, Patel V, Furukawa MF. Physician Adoption of Electronic Health Record Technology to Meet Meaningful Use Objectives: 2009–2012. ONC Data Brief, no. 7. Washington, DC: Office of the National Coordinator for Health Information Technology. December 2012. 6 ONC analysis of data from the 2011 American Hospital Association Survey Information Technology Supplement. Data brief forthcoming. VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 IT (HIT) Certification Program are increasing standards based health information exchange (HIE) across health care providers and settings of care to support greater coordination of health care services. However, this alone will not be enough to achieve the widespread interoperability and electronic exchange of information necessary for delivery reform where information will routinely follow the patient regardless of where they receive care. With fee-for-service reimbursement and other business motivations often being the stronger influencer of provider behavior, both providers and their vendors do not yet have a business imperative to share person level health information across providers and settings of care. For example, in 2011, 4 in 10 hospitals electronically sent laboratory and radiology data to providers outside their organization; however, only 1⁄4 of hospitals could exchange medication lists and clinical summaries with outside providers.7 In addition in 2011, only 31 percent of physicians are exchanging clinical summaries with other providers.8 There is even more limited HIE involving post-acute and institutional long-term care providers as well as behavioral health and lab providers who may not eligible for incentive payments under the EHR incentive program. Only 6 percent of long-term acute care hospitals, 4 percent of rehabilitation hospitals, and 2 percent of psychiatric hospitals have a basic electronic health record system.9 Close to 1⁄3 of all Medicare beneficiaries discharged from acute care hospitals are discharged to post-acute care settings such as rehabilitation hospitals but there is little capacity in the system today to support HIE across these settings.10 Similarly consumers and patients are not actively engaged in accessing and using their personal health information and requesting that their providers do the same. Based upon the 2012 ONC Privacy & Security Survey, 19 percent of consumers reported that they were given online 7 ONC analysis of data from the 2011 American Hospital Association Survey Information Technology Supplement. 8 ONC analysis of data from the 2011 National Ambulatory Medical Care Survey Electronic Health Record Supplement. 9 Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of Electronic Health Records http://content.healthaffairs.org/content/31/ 3/505.full. 10 Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of Electronic Health Records http://content.healthaffairs.org/ content/31/3/505.full. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 access to a part of their medical record by a health care provider within the last 12 months. ONC has been advancing standards based HIE through a variety of programs and initiatives including the Standards and Interoperability Framework, the State HIE Cooperative Agreement Program, the Direct Project, the Nationwide Health Information Network Exchange and the HIT Certification Program. Other HHS policies also encourage HIE through the adoption of interoperable Electronic Health Record (EHR) technology. For example we recognize that the EHR exception to the federal Physician Self-Referral law and EHR safe harbor to the federal AntiKickback Statute which protect the donation of certain software and related training and services when various requirements are met, have created a pathway for arrangements that promote EHR implementation and use. To further accelerate and advance interoperability and health information exchange beyond what is currently being done through ONC programs and the EHR Incentive Program, HHS is considering a number of policy levers using existing authorities and programs. The overarching 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. This goal potentially could be achieved through a combination of incentives, payment adjustments, and requirements that collectively result in a more coordinated, value-driven health care system over the next 1 to 3 years and beyond. The Patient Protection and Affordable Care Act (Pub. L. 111–148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) (collectively referred to as the Affordable Care Act) has created new opportunities to align current and new policies in a way that provides a compelling business and patient care case to providers to change culture and share clinical data with all providers across the health care spectrum as a part of their routine delivery of care and services. The Affordable Care Act initiatives including the Medicare Shared Savings Program, hospital readmission payment adjustments, Medicaid health homes, and new models being tested by the Center for Medicare and Medicaid Innovation are creating a stronger business case for many providers to exchange health information. HHS recognizes the need to use evidence and data on provider behavior to inform ongoing policy development E:\FR\FM\07MRN1.SGM 07MRN1 Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES that will result in a connected, personcentric health care system where health information is routinely shared across providers and settings of care to encourage the consistent provision of high-quality care, promote efficient use of health care resources, and ensure that health outcomes are good and care is affordable. As HHS, the provider, and the health IT vendor communities gain more experience with new delivery models, meaningful use of health IT, and HIE, these insights along with upto-date market data on provider behavior will inform the evolution of policies and programs that accelerate HIE and contribute to better quality care. This request for information (RFI) lays out some of the potential options to accelerate the existing progress and enhance a market environment that will accelerate HIE across providers thereby improving the likelihood of successful delivery and payment reform. HHS is seeking input on the options addressed below, as well as other options that stakeholders believe would be effective and feasible. A. Vision We are on the dawn of a new era of health care delivery—a transformed system that is person-centered and value-based. Existing CMS programs and demonstrations, as well as new programs and initiatives authorized by the Affordable Care Act, focus on improved care coordination and new service delivery and payment models that encourage and facilitate greater coordination of care and improved quality, including accountable care organizations (ACOs), bundled payments, health and medical homes, and reductions in hospital readmission. Critical to the success of these programs and the ultimate goal of a transformed health care system is the real-time electronic exchange of health information. Experts agree that greater access to person level health information is integral to improving the quality, efficiency, and safety of health care delivery.11 The lack of widespread electronic HIE is a significant barrier to achieving truly coordinated, person-centered health care. The Medicare and Medicaid EHR Incentive Programs and other valuebased payment programs are significant 11 McGlynn, E.A., S.M. Asch, J. Adams, J. Keesey, J. Hicks, A. DeCristofaro, and E.A. Kerr, ‘‘The Quality of Health Care Delivered to Adults in the United States.’’ New England Journal of Medicine 2003 348: 2635–45. See also, Rosenbaum, R., ‘‘Data Governance and Stewardship: Designing Data Stewardship Entities and Advancing Data Access,’’ Health Services Research 2010 45:5, Part II. VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 drivers of use of interoperable health information technology and the exchange of health information. We introduced many concepts of interoperability in Stage 2 and expect that the Medicare and Medicaid EHR Incentive Programs criteria for Stage 3 of meaningful use will include requirements for advanced interoperability. As other value-based payment programs evolve, they might include a greater emphasis on HIE as either a requirement for participation, receipt of incentive payments, or avoidance of payment adjustments. However, gaps and challenges still remain to wide-spread use of interoperable systems and HIE across providers, settings of care, consumers and patients, and payers. CMS and ONC will continue to collaborate on the EHR Incentive Program and HIT Certification Program to ensure they support delivery and payment reform. In addition, HHS intends to rely on all applicable and appropriate statutory authorities, regulations, policies, and programs to accelerate rapid adoption of health information exchange across the care continuum in support of delivery and payment reform. This combination of diverse policies and programs will ensure health information follows a person regardless of where they access health care services. HHS envisions an information rich, person-centered, high performance health care system where every health care provider has access to longitudinal data on patients they treat to make evidence-based decisions, coordinate care and improve health outcomes. As the Affordable Care Act continues to be implemented, HHS will develop and evolve policies and programs to achieve this vision. B. Policies and Questions CMS and ONC are jointly issuing this RFI to seek input on policies and programs that would further drive HIE to support more person-centered, coordinated, value-driven care. In section II of this RFI, HHS discusses policies and programs that may further encourage HIE. They are organized by various gaps and challenges that the policies and programs are intended to address (for example, low rates of adoption and HIE among post-acute and long-term care providers). HHS is soliciting comments on these policy and programmatic options, as well as comments on other policy and programmatic options HHS could consider. In addition, the RFI includes several questions in section III on which HHS would like stakeholder input. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 14795 II. Policies and Programs Under Consideration by CMS and ONC A. Low Rates of EHR Adoption and Health Information Exchange Among Post-Acute and Long-Term Care Providers There are a variety of options HHS might pursue to encourage HIE among post-acute and long-term care providers. Some of these options are described below. • CMS has existing authority to allow states flexibility to implement innovative delivery and payment models for Medicare and Medicaid beneficiaries which could accelerate HIE as a part of improving care coordination across acute, post-acute and long-term care providers, reducing avoidable readmissions and improving health outcomes. For example, under section 1945 of the Social Security Act (the Act), added by section 2703 of the Affordable Care Act, states can establish Medicaid health homes for certain beneficiaries by amending their state plans to include the new benefit. Use of HIT is required to the extent ‘‘feasible and appropriate’’ to link services. • Section 1115 of the Act gives the HHS Secretary authority to approve experimental, pilot, or demonstration projects that promote the objectives of Medicaid and Childrens Health Insurance Program (CHIP). These demonstrations give states additional flexibility to design and improve their programs, demonstrate and evaluate policy approaches such as providing services not typically covered by Medicaid or using innovative service delivery systems that improve care, increase efficiency, and reduce costs. Some states use this authority to advance and support their ability to incentivize health outcomes improvement and rely less on traditional forms of payment that reward high volume of discrete services. Furthermore, some of these models build on the concepts in the Medicare Shared Savings Program and encourage disparate providers to create formal arrangements establishing responsibility for managing all Medicaid services and total cost of care for an assigned population, including behavioral health and long-term care. HIE could be an important component of programs like these or other programs that rely on care coordination across settings of care. Special terms and conditions (STCs) for these demonstration projects can require the use of HIE in delivery system and payment reform efforts, to coordinate and manage services, and monitor quality of care. For example, in Oregon’s recent section 1115(a) demonstration E:\FR\FM\07MRN1.SGM 07MRN1 emcdonald on DSK67QTVN1PROD with NOTICES 14796 Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices project (Oregon Health Plan),[1] HIE is fundamental to the delivery system and payment changes being demonstrated. For this reason, the STCs required coordination between the demonstration project, Oregon’s HIE Operational Plan, and the State Medicaid HIT Plan to ensure that these systems support the overall quality improvement and decreased expenditures that are critical to the state’s demonstration. • Section 1915(c) of the Act permits states to provide an array of home and community based services (HCBS), including long term supports and services, to individuals who would otherwise require the level of care provided in certain institutions. Section 1915(i) of the Act permits states to provide these services to certain eligible individuals without considering whether such individuals would otherwise require an institutional level of care. Section 1915(k) permits states to provide home and community-based attendant services to certain eligible individuals that may include skills training for daily life activities and back-up systems to ensure continuity of care and provides an increase in the federal financial participation rate for these services. Under these authorities, states can offer an array of specified home and community based services as well as other services requested by the state and approved by the Secretary that serve the purposes of the benefit. These services are important adjuncts to the care people receive from other areas of the health care system. Encouraging the appropriate exchange of health and other information across all providers involved in caring for these individuals is necessary to support effective care coordination and cost-effective care delivery. Furthermore, tracking their use of the health care system through health information technology will be critically important to development of new models of care delivery. Exchange of health information as beneficiaries transition to home or between providers (including acute, specialty, and primary care) could significantly improve continuity and the quality of their health care and result in reduced expenditures when care is continually managed in community settings. • In addition, CMS issued a State Medicaid Director (SMD) letter regarding a cost allocation policy for developing and sustaining HIE infrastructure as a part of the administration of the Medicaid EHR Incentive Program. Certain state [1] http://medicaid.gov/Medicaid-CHIP-ProgramInformation/By-Topics/Waivers/1115/downloads/ or/or-health-plan2-ca.pdf pgs 121–122. VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 expenditures related to the development and sustaining of HIE may be eligible for 90 percent Federal financial participation (FFP) under this program, however, CMS approval of funding for HIE infrastructure costs requires assurances that other payers and providers will bear an appropriate share of the costs, risks and governance. States could propose to implement HIE infrastructure enhancements that enable the creation and exchange of health information across settings of care, including post-acute and long-term care providers with the Medicaid program. CMS’ Conditions of Participation or Coverage are designed to ensure that providers and suppliers maintain health care quality and safety. CMS and State staff oversee compliance with Medicare health and safety standards in hospitals, laboratories, nursing homes, home health agencies, hospices, rural health clinics, ambulatory surgical centers, organ transplant centers, and End Stage Renal Disease facilities. CMS has a role in advancing clinical standards in keeping with advancements in health IT capacity and the implementation of delivery and payment reforms in the Affordable Care Act that increasingly rely on coordination of care across institutional and non-institutional settings of care. CMS could require new clinical standards in the form of conditions of participation or requirements to ensure timely, electronic exchange of health information to support patient admissions, discharge, and transfers as well as care planning to ensure care continuity as patients receive care across inpatient, post-acute and longterm care providers. B. Low Rates of HIE Across Settings of Care and Providers There are several potential ways in which HHS might accelerate HIE across providers including ambulatory care, post-acute and long-term care, behavioral health, and lab providers. Four examples of options are briefly summarized below. • HHS can collaborate in the development of new e-specified measures of care coordination that encourage electronic sharing of summary records following transitions in care. This could be incorporated into and aligned across multiple programs including the EHR Incentive Program, and other CMS quality reporting programs. • The Medicare Shared Savings Program establishes requirements for participating ACOs. CMS might consider new ways to require or encourage Medicare ACOs to exchange PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 health information as a part of coordination of care across aligned providers or patient engagement strategies. Currently, meaningful use of EHRs is treated as a measure of quality, which is used to determine ACO eligibility for the shared savings and/or shared losses. • Under the Affordable Care Act, CMS has the authority to test innovative payment and service delivery models that have the potential to reduce Medicare, Medicaid, or CHIP expenditures while maintaining or improving the quality of care for beneficiaries. Several new models are underway that encourage the use of HIE in support of care coordination such as the Bundled Payments for Care Improvement Initiative, Comprehensive Primary Care Initiative, the Pioneer ACO model and the State Innovation Model Initiative. For future and new models, CMS could request applicants to explain how they are using interoperable technology to advance HIE strategies in support of care coordination and quality improvement. Their HIE capacity could be factored into model participation decisions, as well as requirements over the model testing period, similar to meaningful use requirements under the Pioneer ACO model. • Under the Affordable Care Act authority, CMS is testing models to better align the financing of Medicare and Medicaid and integrate care delivery for people who are enrolled in both Medicare and Medicaid, also known as dual eligibles. Under the Capitated Financial Alignment model, CMS will contract with states and health plans, and the health plans will receive a prospective, blended payment to provide comprehensive, coordinated care. CMS could address requirements, expectations, and/or the role of HIE in these new arrangements, which have the potential to use HIE to deliver a higher degree of coordinated care for this fragile and costly population whose members often see numerous types of providers and require a high degree of care. C. Low Rates of Consumer and Patient Engagement CMS wants to encourage beneficiary engagement in their care through improved beneficiary access to their personal health information and better electronic communication between beneficiaries and their health care team. There are several ways CMS could encourage beneficiary access to their information through the use of new measures or patient-reported care experiences, new technology tools, and E:\FR\FM\07MRN1.SGM 07MRN1 emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices new financial models. These options are described below. • The Medicare Advantage Program could encourage improved beneficiary access to their personal health information by incorporating new measures in the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey. The Medicare CAHPS® surveys are a set of surveys sponsored by CMS that collect consumer evaluations of health care experiences that are not currently assessed by other means. Questions could be expanded to include topics such as the extent to which patients believe they are able to participate collaboratively in decisions about their health, and the extent to which information technology supports their ability to share and communicate with providers and other members of their health care team, and manage their care between various providers. • CMS could promote the use of Blue Button. The Blue Button provides easy electronic access to personal health information for consumers. To strengthen its success, ONC released guidelines for data holders and application developers that support the growth of an ecosystem of tools to help consumers manage their health. The Blue Button Plus guidelines include specifications for a structured data format (consistent with Meaningful Use Stage 2), and enable updates of the information contained in individual consumer’s health records to be sent automatically to the applications of their choice. Tools built on Blue Button Plus specifications could be made available to all CMS beneficiaries, and widely promoted by healthcare providers and via avenues such as the Medicare Handbook, Medicare.gov, and Medicare Advantage plans. • As stated previously, under the Affordable Care Act, CMS has the authority to test innovative payment and service delivery models that have the potential to reduce program expenditures while maintaining or improving the quality of care for beneficiaries. In future and new models, CMS could encourage applicants to experiment with providing incentives for consumers to more actively participate in their health and health care—including through shareddecision making—supported by the collection, use, and sharing of electronic health information. • Modifications to Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule could enable patients’ direct access to their lab VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 results from laboratories. CMS and the HHS Office for Civil Rights (OCR) received public comments on this potential modification through a notice for proposed rulemaking (76 FR 56712). III. Questions for Public Comment CMS and ONC are soliciting public comments on the following questions: 1. What changes in payment policy would have the most impact on the electronic exchange of health information, particularly among those organizations that are market competitors? 2. Which of the following programs are having the greatest impact on encouraging electronic health information exchange: Hospital readmission payment adjustments, value-based purchasing, bundled payments, ACOs, Medicare Advantage, Medicare and Medicaid EHR Incentive Programs (Meaningful Use), or medical/ health homes? Are there any aspects of the design or implementation of these programs that are limiting their potential impact on encouraging care coordination and quality improvement across settings of care and among organizations that are market competitors? 3. To what extent do current CMS payment policies encourage or impede electronic information exchange across health care provider organizations, particularly those that may be market competitors? Furthermore, what CMS and ONC programs and policies would specifically address the cultural and economic disincentives for HIE that result in ‘‘data lock-in’’ or restricting consumer and provider choice in services and providers? Are there specific ways in which providers and vendors could be encouraged to send, receive, and integrate health information from other treating providers outside of their practice or system? 4. What CMS and ONC policies and programs would most impact post acute, long term care providers (institutional and HCBS) and behavioral health providers’ (for example, mental health and substance use disorders) exchange of health information, including electronic HIE, with other treating providers? How should these programs and policies be developed and/or implemented to maximize the impact on care coordination and quality improvement? 5. How could CMS and states use existing authorities to better support electronic and interoperable HIE among Medicare and Medicaid providers, including post acute, long-term care, and behavioral health providers? PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 14797 6. How can CMS leverage regulatory requirements for acceptable quality in the operation of health care entities, such as conditions of participation for hospitals or requirements for SNFs, NFs, and home health to support and accelerate electronic, interoperable health information exchange? How could requirements for acceptable quality that involve health information exchange be phased in overtime? How might compliance with any such regulatory requirements be best assessed and enforced, especially since specialized HIT knowledge may be required to make such assessments? 7. How could the EHR Incentives Program advance provider directories that would support exchange of health information between Eligible Professionals participating in the program. For example, could the attestation process capture provider identifiers that could be accessed to enable exchange among participating EPs? 8. How can the new authorities under the Affordable Care Act for CMS test, evaluate, and scale innovative payment and service delivery models best accelerate standards- based electronic HIE across treating providers? 9. What CMS and ONC policies and programs would most impact patient access and use of their electronic health information in the management of their care and health? How should CMS and ONC develop, refine and/or implement policies and program to maximize beneficiary access to their health information and engagement in their care? What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results? Dated: February 22, 2013. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: February 27, 2013. Farzad Mostashari, National Coordinator. [FR Doc. 2013–05266 Filed 3–6–13; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14793-14797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Centers for Medicare & Medicaid Services

[CMS-0038-NC]


Advancing Interoperability and Health Information Exchange

AGENCY: Office of the National Coordinator for Health Information 
Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment; Request for Information.

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SUMMARY: HHS seeks input on a series of potential policy and 
programmatic changes to accelerate electronic health information 
exchange across providers, as well as new ideas that would be both 
effective and feasible to implement. To further accelerate and advance 
interoperability and health information exchange beyond what is 
currently being done through ONC programs and the EHR Incentive 
Program, HHS is considering a number of policy levers using existing 
authorities and programs.

DATES: To be assured consideration, written or electronic comments must 
be received at one of the addresses provided below, no later than 5 
p.m. on April 22, 2013.

ADDRESSES: You may submit comments identified by any of the following 
methods below (please do not submit duplicate comments). Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
     Federal eRulemaking Portal: Follow the instructions for 
submitting comments. Attachments should be in Microsoft Word or Excel, 
Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov.
     Regular, Express, or Overnight Mail: Department of Health 
and Human Services, Office of the National Coordinator for Health 
Information Technology, Attention: Interoperability RFI, Hubert H. 
Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, 
DC 20201. Please submit one original and two copies.
     Hand Delivery or Courier: Office of the National 
Coordinator for Health Information Technology, Attention: 
Interoperability RFI, Hubert H. Humphrey Building, Suite 729D, 200 
Independence Ave. SW., Washington, DC 20201. Please submit one original 
and two copies. (Because access to the interior of the Hubert H. 
Humphrey Building is not readily available to persons without federal 
government identification, commenters are encouraged to leave their 
comments in the mail drop slots located in the main lobby of the 
building.)
    Inspection of Public Comments: All comments received before the 
close of the comment period will be available for public inspection, 
including any personally identifiable or confidential business 
information that is included in a comment. Please do not include 
anything in your comment submission that you do not wish to share with 
the general public. Such information includes, but is not limited to: A 
person's social security number; date of birth; driver's license 
number; state identification number or foreign country equivalent; 
passport number; financial account number; credit or debit card number; 
any personal health information; or any business information that could 
be considered to be proprietary. We will post all comments received 
before the close of the comment period at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov or the Department 
of Health and Human Services, Office of the National Coordinator for 
Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 
200 Independence Ave. SW., Washington, DC 20201 (call ahead to the 
contact listed below to arrange for inspection).

FOR FURTHER INFORMATION CONTACT: 
     Kelly Cronin, Health Care Reform Coordinator; or
     Steven Posnack, Director, Federal Policy Division
    Office of the National Coordinator for Health Information 
Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION: 

I. Background

    Since enactment of the Health Information Technology for Clinical 
and Economic Health Act as part of the American Recovery and 
Reinvestment Act, adoption and use of electronic health records in the 
United States has dramatically increased. Adoption of EHRs that met the 
criteria for a basic EHR system by office-based physicians grew by over 
80% between 2009 and 2012, from 22% in 2009 to 40% in 
2012.1 2 Among non-federal acute care

[[Page 14794]]

hospitals, adoption of at least a basic EHR system has increased by 
over 260% since 2009, from 12% to 44%.3 4 Since 2009, there 
has been strong and steady growth in adoption of EHR technology to meet 
Meaningful Use objectives to improve quality, safety and efficiency. 
Adoption of many of the computerized functionalities associated with 
Meaningful Use has substantially increased among both office-based 
physicians as well as hospitals.5 6 For example, physician 
adoption of five core Meaningful Use functionalities--ranging from e-
prescribing to clinical decision support--has grown by at least 66% 
since HITECH in 2009.
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    \1\ Hsiao CJ, Hing E. Use and characteristics of electronic 
health record systems among office-based physician practices: United 
States, 2001-2012. NCHS data brief, no 111. Hyattsville, MD: 
National Center for Health Statistics. 2012.
    \2\ A basic EHR system for office-based practices includes the 
following functionalities: Patient history and demographics, patient 
problem lists, physician clinical notes, comprehensive list of 
patients' medications and allergies, computerized orders for 
prescriptions, and ability to view laboratory and imaging results 
electronically. Note that functionalities associated with basic EHR 
differ from functionalities required for meaningful use.
    \3\ ONC analysis of data from the 2011 American Hospital 
Association Survey Information Technology Supplement. Data brief 
forthcoming.
    \4\ A basic EHR system for hospitals includes the following 
functionalities: Patient history and demographics, patient problem 
lists, physician clinical notes, nursing assessments, comprehensive 
list of patients' medications and allergies, discharge summaries, 
computerized orders for prescriptions, and the ability to view 
diagnostic test results, laboratory reports and radiology reports 
electronically. Note that functionalities associated with basic EHR 
differ from functionalities required for meaningful use.
    \5\ King J, Patel V, Furukawa MF. Physician Adoption of 
Electronic Health Record Technology to Meet Meaningful Use 
Objectives: 2009-2012. ONC Data Brief, no. 7. Washington, DC: Office 
of the National Coordinator for Health Information Technology. 
December 2012.
    \6\ ONC analysis of data from the 2011 American Hospital 
Association Survey Information Technology Supplement. Data brief 
forthcoming.
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    As part of stage 2 rulemaking HHS has taken major steps to expand 
the functionality and utility of EHRs to providers and patients. We 
seek to build on that work by engaging other policy areas within HHS 
jurisdiction to promote routine sharing of information among health 
care providers across settings of care to support care coordination and 
delivery system reform. We also recognize that economic and regulatory 
barriers may impair the development of a patient centered, information 
rich, high performance health care system where a persons' health 
information follows them wherever they access health care services.
    The Medicare and Medicaid Electronic Health Record (EHR) Incentive 
Programs and Office of the National Coordinator (ONC) for Health IT 
(HIT) Certification Program are increasing standards based health 
information exchange (HIE) across health care providers and settings of 
care to support greater coordination of health care services. However, 
this alone will not be enough to achieve the widespread 
interoperability and electronic exchange of information necessary for 
delivery reform where information will routinely follow the patient 
regardless of where they receive care. With fee-for-service 
reimbursement and other business motivations often being the stronger 
influencer of provider behavior, both providers and their vendors do 
not yet have a business imperative to share person level health 
information across providers and settings of care.
    For example, in 2011, 4 in 10 hospitals electronically sent 
laboratory and radiology data to providers outside their organization; 
however, only \1/4\ of hospitals could exchange medication lists and 
clinical summaries with outside providers.\7\ In addition in 2011, only 
31 percent of physicians are exchanging clinical summaries with other 
providers.\8\ There is even more limited HIE involving post-acute and 
institutional long-term care providers as well as behavioral health and 
lab providers who may not eligible for incentive payments under the EHR 
incentive program. Only 6 percent of long-term acute care hospitals, 4 
percent of rehabilitation hospitals, and 2 percent of psychiatric 
hospitals have a basic electronic health record system.\9\ Close to \1/
3\ of all Medicare beneficiaries discharged from acute care hospitals 
are discharged to post-acute care settings such as rehabilitation 
hospitals but there is little capacity in the system today to support 
HIE across these settings.\10\ Similarly consumers and patients are not 
actively engaged in accessing and using their personal health 
information and requesting that their providers do the same. Based upon 
the 2012 ONC Privacy & Security Survey, 19 percent of consumers 
reported that they were given online access to a part of their medical 
record by a health care provider within the last 12 months.
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    \7\ ONC analysis of data from the 2011 American Hospital 
Association Survey Information Technology Supplement.
    \8\ ONC analysis of data from the 2011 National Ambulatory 
Medical Care Survey Electronic Health Record Supplement.
    \9\ Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal 
Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of 
Electronic Health Records http://content.healthaffairs.org/content/31/3/505.full.
    \10\ Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal 
Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of 
Electronic Health Records http://content.healthaffairs.org/content/31/3/505.full.
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    ONC has been advancing standards based HIE through a variety of 
programs and initiatives including the Standards and Interoperability 
Framework, the State HIE Cooperative Agreement Program, the Direct 
Project, the Nationwide Health Information Network Exchange and the HIT 
Certification Program. Other HHS policies also encourage HIE through 
the adoption of interoperable Electronic Health Record (EHR) 
technology. For example we recognize that the EHR exception to the 
federal Physician Self-Referral law and EHR safe harbor to the federal 
Anti-Kickback Statute which protect the donation of certain software 
and related training and services when various requirements are met, 
have created a pathway for arrangements that promote EHR implementation 
and use. To further accelerate and advance interoperability and health 
information exchange beyond what is currently being done through ONC 
programs and the EHR Incentive Program, HHS is considering a number of 
policy levers using existing authorities and programs. The overarching 
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. This goal potentially could be achieved through a 
combination of incentives, payment adjustments, and requirements that 
collectively result in a more coordinated, value-driven health care 
system over the next 1 to 3 years and beyond. The Patient Protection 
and Affordable Care Act (Pub. L. 111-148), as amended by the Health 
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) 
(collectively referred to as the Affordable Care Act) has created new 
opportunities to align current and new policies in a way that provides 
a compelling business and patient care case to providers to change 
culture and share clinical data with all providers across the health 
care spectrum as a part of their routine delivery of care and services. 
The Affordable Care Act initiatives including the Medicare Shared 
Savings Program, hospital readmission payment adjustments, Medicaid 
health homes, and new models being tested by the Center for Medicare 
and Medicaid Innovation are creating a stronger business case for many 
providers to exchange health information.
    HHS recognizes the need to use evidence and data on provider 
behavior to inform ongoing policy development

[[Page 14795]]

that will result in a connected, person-centric health care system 
where health information is routinely shared across providers and 
settings of care to encourage the consistent provision of high-quality 
care, promote efficient use of health care resources, and ensure that 
health outcomes are good and care is affordable. As HHS, the provider, 
and the health IT vendor communities gain more experience with new 
delivery models, meaningful use of health IT, and HIE, these insights 
along with up-to-date market data on provider behavior will inform the 
evolution of policies and programs that accelerate HIE and contribute 
to better quality care.
    This request for information (RFI) lays out some of the potential 
options to accelerate the existing progress and enhance a market 
environment that will accelerate HIE across providers thereby improving 
the likelihood of successful delivery and payment reform. HHS is 
seeking input on the options addressed below, as well as other options 
that stakeholders believe would be effective and feasible.

A. Vision

    We are on the dawn of a new era of health care delivery--a 
transformed system that is person-centered and value-based. Existing 
CMS programs and demonstrations, as well as new programs and 
initiatives authorized by the Affordable Care Act, focus on improved 
care coordination and new service delivery and payment models that 
encourage and facilitate greater coordination of care and improved 
quality, including accountable care organizations (ACOs), bundled 
payments, health and medical homes, and reductions in hospital 
readmission. Critical to the success of these programs and the ultimate 
goal of a transformed health care system is the real-time electronic 
exchange of health information. Experts agree that greater access to 
person level health information is integral to improving the quality, 
efficiency, and safety of health care delivery.\11\
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    \11\ McGlynn, E.A., S.M. Asch, J. Adams, J. Keesey, J. Hicks, A. 
DeCristofaro, and E.A. Kerr, ``The Quality of Health Care Delivered 
to Adults in the United States.'' New England Journal of Medicine 
2003 348: 2635-45. See also, Rosenbaum, R., ``Data Governance and 
Stewardship: Designing Data Stewardship Entities and Advancing Data 
Access,'' Health Services Research 2010 45:5, Part II.
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    The lack of widespread electronic HIE is a significant barrier to 
achieving truly coordinated, person-centered health care. The Medicare 
and Medicaid EHR Incentive Programs and other value-based payment 
programs are significant drivers of use of interoperable health 
information technology and the exchange of health information. We 
introduced many concepts of interoperability in Stage 2 and expect that 
the Medicare and Medicaid EHR Incentive Programs criteria for Stage 3 
of meaningful use will include requirements for advanced 
interoperability. As other value-based payment programs evolve, they 
might include a greater emphasis on HIE as either a requirement for 
participation, receipt of incentive payments, or avoidance of payment 
adjustments. However, gaps and challenges still remain to wide-spread 
use of interoperable systems and HIE across providers, settings of 
care, consumers and patients, and payers. CMS and ONC will continue to 
collaborate on the EHR Incentive Program and HIT Certification Program 
to ensure they support delivery and payment reform. In addition, HHS 
intends to rely on all applicable and appropriate statutory 
authorities, regulations, policies, and programs to accelerate rapid 
adoption of health information exchange across the care continuum in 
support of delivery and payment reform. This combination of diverse 
policies and programs will ensure health information follows a person 
regardless of where they access health care services. HHS envisions an 
information rich, person-centered, high performance health care system 
where every health care provider has access to longitudinal data on 
patients they treat to make evidence-based decisions, coordinate care 
and improve health outcomes. As the Affordable Care Act continues to be 
implemented, HHS will develop and evolve policies and programs to 
achieve this vision.

B. Policies and Questions

    CMS and ONC are jointly issuing this RFI to seek input on policies 
and programs that would further drive HIE to support more person-
centered, coordinated, value-driven care. In section II of this RFI, 
HHS discusses policies and programs that may further encourage HIE. 
They are organized by various gaps and challenges that the policies and 
programs are intended to address (for example, low rates of adoption 
and HIE among post-acute and long-term care providers). HHS is 
soliciting comments on these policy and programmatic options, as well 
as comments on other policy and programmatic options HHS could 
consider. In addition, the RFI includes several questions in section 
III on which HHS would like stakeholder input.

II. Policies and Programs Under Consideration by CMS and ONC

A. Low Rates of EHR Adoption and Health Information Exchange Among 
Post-Acute and Long-Term Care Providers

    There are a variety of options HHS might pursue to encourage HIE 
among post-acute and long-term care providers. Some of these options 
are described below.
     CMS has existing authority to allow states flexibility to 
implement innovative delivery and payment models for Medicare and 
Medicaid beneficiaries which could accelerate HIE as a part of 
improving care coordination across acute, post-acute and long-term care 
providers, reducing avoidable readmissions and improving health 
outcomes. For example, under section 1945 of the Social Security Act 
(the Act), added by section 2703 of the Affordable Care Act, states can 
establish Medicaid health homes for certain beneficiaries by amending 
their state plans to include the new benefit. Use of HIT is required to 
the extent ``feasible and appropriate'' to link services.
     Section 1115 of the Act gives the HHS Secretary authority 
to approve experimental, pilot, or demonstration projects that promote 
the objectives of Medicaid and Childrens Health Insurance Program 
(CHIP). These demonstrations give states additional flexibility to 
design and improve their programs, demonstrate and evaluate policy 
approaches such as providing services not typically covered by Medicaid 
or using innovative service delivery systems that improve care, 
increase efficiency, and reduce costs. Some states use this authority 
to advance and support their ability to incentivize health outcomes 
improvement and rely less on traditional forms of payment that reward 
high volume of discrete services. Furthermore, some of these models 
build on the concepts in the Medicare Shared Savings Program and 
encourage disparate providers to create formal arrangements 
establishing responsibility for managing all Medicaid services and 
total cost of care for an assigned population, including behavioral 
health and long-term care. HIE could be an important component of 
programs like these or other programs that rely on care coordination 
across settings of care. Special terms and conditions (STCs) for these 
demonstration projects can require the use of HIE in delivery system 
and payment reform efforts, to coordinate and manage services, and 
monitor quality of care. For example, in Oregon's recent section 
1115(a) demonstration

[[Page 14796]]

project (Oregon Health Plan),[1] HIE is fundamental to the 
delivery system and payment changes being demonstrated. For this 
reason, the STCs required coordination between the demonstration 
project, Oregon's HIE Operational Plan, and the State Medicaid HIT Plan 
to ensure that these systems support the overall quality improvement 
and decreased expenditures that are critical to the state's 
demonstration.
---------------------------------------------------------------------------

    \[1]\ http://medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Waivers/1115/downloads/or/or-health-plan2-ca.pdf pgs 121-122.
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     Section 1915(c) of the Act permits states to provide an 
array of home and community based services (HCBS), including long term 
supports and services, to individuals who would otherwise require the 
level of care provided in certain institutions. Section 1915(i) of the 
Act permits states to provide these services to certain eligible 
individuals without considering whether such individuals would 
otherwise require an institutional level of care. Section 1915(k) 
permits states to provide home and community-based attendant services 
to certain eligible individuals that may include skills training for 
daily life activities and back-up systems to ensure continuity of care 
and provides an increase in the federal financial participation rate 
for these services. Under these authorities, states can offer an array 
of specified home and community based services as well as other 
services requested by the state and approved by the Secretary that 
serve the purposes of the benefit. These services are important 
adjuncts to the care people receive from other areas of the health care 
system. Encouraging the appropriate exchange of health and other 
information across all providers involved in caring for these 
individuals is necessary to support effective care coordination and 
cost-effective care delivery. Furthermore, tracking their use of the 
health care system through health information technology will be 
critically important to development of new models of care delivery. 
Exchange of health information as beneficiaries transition to home or 
between providers (including acute, specialty, and primary care) could 
significantly improve continuity and the quality of their health care 
and result in reduced expenditures when care is continually managed in 
community settings.
     In addition, CMS issued a State Medicaid Director (SMD) 
letter regarding a cost allocation policy for developing and sustaining 
HIE infrastructure as a part of the administration of the Medicaid EHR 
Incentive Program. Certain state expenditures related to the 
development and sustaining of HIE may be eligible for 90 percent 
Federal financial participation (FFP) under this program, however, CMS 
approval of funding for HIE infrastructure costs requires assurances 
that other payers and providers will bear an appropriate share of the 
costs, risks and governance. States could propose to implement HIE 
infrastructure enhancements that enable the creation and exchange of 
health information across settings of care, including post-acute and 
long-term care providers with the Medicaid program.
    CMS' Conditions of Participation or Coverage are designed to ensure 
that providers and suppliers maintain health care quality and safety. 
CMS and State staff oversee compliance with Medicare health and safety 
standards in hospitals, laboratories, nursing homes, home health 
agencies, hospices, rural health clinics, ambulatory surgical centers, 
organ transplant centers, and End Stage Renal Disease facilities. CMS 
has a role in advancing clinical standards in keeping with advancements 
in health IT capacity and the implementation of delivery and payment 
reforms in the Affordable Care Act that increasingly rely on 
coordination of care across institutional and non-institutional 
settings of care. CMS could require new clinical standards in the form 
of conditions of participation or requirements to ensure timely, 
electronic exchange of health information to support patient 
admissions, discharge, and transfers as well as care planning to ensure 
care continuity as patients receive care across inpatient, post-acute 
and long-term care providers.

B. Low Rates of HIE Across Settings of Care and Providers

    There are several potential ways in which HHS might accelerate HIE 
across providers including ambulatory care, post-acute and long-term 
care, behavioral health, and lab providers. Four examples of options 
are briefly summarized below.
     HHS can collaborate in the development of new e-specified 
measures of care coordination that encourage electronic sharing of 
summary records following transitions in care. This could be 
incorporated into and aligned across multiple programs including the 
EHR Incentive Program, and other CMS quality reporting programs.
     The Medicare Shared Savings Program establishes 
requirements for participating ACOs. CMS might consider new ways to 
require or encourage Medicare ACOs to exchange health information as a 
part of coordination of care across aligned providers or patient 
engagement strategies. Currently, meaningful use of EHRs is treated as 
a measure of quality, which is used to determine ACO eligibility for 
the shared savings and/or shared losses.
     Under the Affordable Care Act, CMS has the authority to 
test innovative payment and service delivery models that have the 
potential to reduce Medicare, Medicaid, or CHIP expenditures while 
maintaining or improving the quality of care for beneficiaries. Several 
new models are underway that encourage the use of HIE in support of 
care coordination such as the Bundled Payments for Care Improvement 
Initiative, Comprehensive Primary Care Initiative, the Pioneer ACO 
model and the State Innovation Model Initiative. For future and new 
models, CMS could request applicants to explain how they are using 
interoperable technology to advance HIE strategies in support of care 
coordination and quality improvement. Their HIE capacity could be 
factored into model participation decisions, as well as requirements 
over the model testing period, similar to meaningful use requirements 
under the Pioneer ACO model.
     Under the Affordable Care Act authority, CMS is testing 
models to better align the financing of Medicare and Medicaid and 
integrate care delivery for people who are enrolled in both Medicare 
and Medicaid, also known as dual eligibles. Under the Capitated 
Financial Alignment model, CMS will contract with states and health 
plans, and the health plans will receive a prospective, blended payment 
to provide comprehensive, coordinated care. CMS could address 
requirements, expectations, and/or the role of HIE in these new 
arrangements, which have the potential to use HIE to deliver a higher 
degree of coordinated care for this fragile and costly population whose 
members often see numerous types of providers and require a high degree 
of care.

C. Low Rates of Consumer and Patient Engagement

    CMS wants to encourage beneficiary engagement in their care through 
improved beneficiary access to their personal health information and 
better electronic communication between beneficiaries and their health 
care team. There are several ways CMS could encourage beneficiary 
access to their information through the use of new measures or patient-
reported care experiences, new technology tools, and

[[Page 14797]]

new financial models. These options are described below.
     The Medicare Advantage Program could encourage improved 
beneficiary access to their personal health information by 
incorporating new measures in the Consumer Assessment of Healthcare 
Providers and Systems (CAHPS[supreg]) survey. The Medicare 
CAHPS[supreg] surveys are a set of surveys sponsored by CMS that 
collect consumer evaluations of health care experiences that are not 
currently assessed by other means. Questions could be expanded to 
include topics such as the extent to which patients believe they are 
able to participate collaboratively in decisions about their health, 
and the extent to which information technology supports their ability 
to share and communicate with providers and other members of their 
health care team, and manage their care between various providers.
     CMS could promote the use of Blue Button. The Blue Button 
provides easy electronic access to personal health information for 
consumers. To strengthen its success, ONC released guidelines for data 
holders and application developers that support the growth of an 
ecosystem of tools to help consumers manage their health. The Blue 
Button Plus guidelines include specifications for a structured data 
format (consistent with Meaningful Use Stage 2), and enable updates of 
the information contained in individual consumer's health records to be 
sent automatically to the applications of their choice. Tools built on 
Blue Button Plus specifications could be made available to all CMS 
beneficiaries, and widely promoted by healthcare providers and via 
avenues such as the Medicare Handbook, Medicare.gov, and Medicare 
Advantage plans.
     As stated previously, under the Affordable Care Act, CMS 
has the authority to test innovative payment and service delivery 
models that have the potential to reduce program expenditures while 
maintaining or improving the quality of care for beneficiaries. In 
future and new models, CMS could encourage applicants to experiment 
with providing incentives for consumers to more actively participate in 
their health and health care--including through shared-decision 
making--supported by the collection, use, and sharing of electronic 
health information.
     Modifications to Clinical Laboratory Improvement 
Amendments of 1988 regulations and the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule could enable patients' 
direct access to their lab results from laboratories. CMS and the HHS 
Office for Civil Rights (OCR) received public comments on this 
potential modification through a notice for proposed rulemaking (76 FR 
56712).

III. Questions for Public Comment

    CMS and ONC are soliciting public comments on the following 
questions:
    1. What changes in payment policy would have the most impact on the 
electronic exchange of health information, particularly among those 
organizations that are market competitors?
    2. Which of the following programs are having the greatest impact 
on encouraging electronic health information exchange: Hospital 
readmission payment adjustments, value-based purchasing, bundled 
payments, ACOs, Medicare Advantage, Medicare and Medicaid EHR Incentive 
Programs (Meaningful Use), or medical/health homes? Are there any 
aspects of the design or implementation of these programs that are 
limiting their potential impact on encouraging care coordination and 
quality improvement across settings of care and among organizations 
that are market competitors?
    3. To what extent do current CMS payment policies encourage or 
impede electronic information exchange across health care provider 
organizations, particularly those that may be market competitors? 
Furthermore, what CMS and ONC programs and policies would specifically 
address the cultural and economic disincentives for HIE that result in 
``data lock-in'' or restricting consumer and provider choice in 
services and providers? Are there specific ways in which providers and 
vendors could be encouraged to send, receive, and integrate health 
information from other treating providers outside of their practice or 
system?
    4. What CMS and ONC policies and programs would most impact post 
acute, long term care providers (institutional and HCBS) and behavioral 
health providers' (for example, mental health and substance use 
disorders) exchange of health information, including electronic HIE, 
with other treating providers? How should these programs and policies 
be developed and/or implemented to maximize the impact on care 
coordination and quality improvement?
    5. How could CMS and states use existing authorities to better 
support electronic and interoperable HIE among Medicare and Medicaid 
providers, including post acute, long-term care, and behavioral health 
providers?
    6. How can CMS leverage regulatory requirements for acceptable 
quality in the operation of health care entities, such as conditions of 
participation for hospitals or requirements for SNFs, NFs, and home 
health to support and accelerate electronic, interoperable health 
information exchange? How could requirements for acceptable quality 
that involve health information exchange be phased in overtime? How 
might compliance with any such regulatory requirements be best assessed 
and enforced, especially since specialized HIT knowledge may be 
required to make such assessments?
    7. How could the EHR Incentives Program advance provider 
directories that would support exchange of health information between 
Eligible Professionals participating in the program. For example, could 
the attestation process capture provider identifiers that could be 
accessed to enable exchange among participating EPs?
    8. How can the new authorities under the Affordable Care Act for 
CMS test, evaluate, and scale innovative payment and service delivery 
models best accelerate standards- based electronic HIE across treating 
providers?
    9. What CMS and ONC policies and programs would most impact patient 
access and use of their electronic health information in the management 
of their care and health? How should CMS and ONC develop, refine and/or 
implement policies and program to maximize beneficiary access to their 
health information and engagement in their care?
    What specific HHS policy changes would significantly increase 
standards based electronic exchange of laboratory results?

    Dated: February 22, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: February 27, 2013.
Farzad Mostashari,
National Coordinator.
[FR Doc. 2013-05266 Filed 3-6-13; 8:45 am]
BILLING CODE 4150-45-P