Information blocking remains prevalent at the start of 21st Century Cures Act: results from a survey of health information exchange organizations.

OBJECTIVE: Recent policy making aims to prevent health systems, lectronic health record (EHR) vendors, and others from blocking the electronic sharing of patient data necessary for clinical care. We sought to assess the prevalence of information blocking prior to enforcement of these rules. MATERIALS AND METHODS: We conducted a national survey of health information exchange organizations (HIEs) to measure the prevalence of information blocking behaviors observed by these third-party entities. Eighty-nine of 106 HIEs (84%) meeting the inclusion criteria responded. RESULTS: The majority (55%) of HIEs reported that EHR vendors at least sometimes engage in information blocking, while 30% of HIEs reported the same for health systems. The most common type of information blocking behavior EHR vendors engaged in was setting unreasonably high prices, which 42% of HIEs reported routinely observing. The most common type of information blocking behavior health systems engaged in was refusing to share information, which 14% of HIEs reported routinely observing. Reported levels of vendor information blocking was correlated with regional competition among vendors and information blocking was concentrated in some geographic regions. DISCUSSION: Our findings are consistent with early reports, revealing persistently high levels of information blocking and important variation by actor, type of behavior, and geography. These trends reflect the observations and experiences of HIEs and their potential biases. Nevertheless, these data serve as a baseline against which to measure the impact of new regulations and to inform policy makers about the most common types of information blocking behaviors. CONCLUSION: Enforcement aimed at reducing information blocking should consider variation in prevalence and how to most effectively target efforts.

Opt-in consent policies: potential barriers to hospital health information exchange.

OBJECTIVES: To (1) assess whether hospitals in states requiring explicit patient consent ("opt-in") for health information exchange (HIE) are more likely to report regulatory barriers to HIE and (2) analyze whether these policies correlate with hospital volume of HIE. STUDY DESIGN: Cross-sectional analysis of US nonfederal acute care hospitals in 2016. METHODS: We combined legal scholarship surveying HIE-relevant state laws with the American Hospital Association Annual Information Technology Supplement for regulatory barriers and hospital characteristics. Data from CMS reports for hospitals attesting to Meaningful Use stage 2 (MU2; renamed "Promoting Interoperability" in 2018) in 2016 captured hospital HIE volume. We used multivariate logistic regression and linear regression to estimate the association of opt-in state consent policies with reported regulatory barriers and HIE volume, respectively. RESULTS: Hospitals in states with opt-in consent policies were 7.8 percentage points more likely than hospitals in opt-out states to report regulatory barriers to HIE (P = .03). In subgroup analyses, this finding held among hospitals that did not attest to MU2 (7.7 percentage points; P = .02). Among hospitals attesting, we did not find a relationship between opt-in policies and regulatory barriers (8.0 percentage points; P = .13) or evidence of a relationship between opt-in policies and HIE volume (ß = 0.56; P = .76). CONCLUSIONS: Our findings suggest that opt-in consent laws may carry greater administrative burdens compared with opt-out policies. However, less technologically advanced hospitals may bear more of this burden. Furthermore, opt-in policies may not affect HIE volume for hospitals that have already achieved a degree of technological sophistication. Policy makers should carefully consider the incidence of administrative burdens when crafting laws pertaining to HIE.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.

The 21st Century Cures Act and electronic health records one year later: will patients see the benefits?

While federal regulation provides patients the right to access their electronic health records and promotes increased use of health information technology, patient access to electronic health records remains limited. The 21st Century Cures Act, signed into law over a year ago, has important provisions that could significantly improve access and availability of health data. Specifically, the provisions call for partnerships among health information exchange networks, educational and research initiatives, and health information technology certification requirements that encourage interoperability. The article reviews the potential benefits and concerns regarding implementation of these provisions, particularly the difficulty of aligning incentives and requirements for data sharing and the question of whether currently proposed rules and guidance will support the goal of improved patient access and health information exchange. Researchers, clinicians, and patients have the power to advocate for improved patient access and interoperability as policy development and implementation of the 21st Century Cures Act continues.

Legal Barriers to the Growth of Health Information Exchange-Boulders or Pebbles?

Policy Points: Historically, in addition to economic and technical hurdles, state and federal health information privacy laws have been cited as a significant obstacle to expanding electronic health information exchange (HIE) in the United States. Our review finds that over the past decade, several helpful developments have ameliorated the legal barriers to HIE, although variation in states' patient consent requirements remains a challenge. Today, health care providers' complaints about legal obstacles to HIE may be better understood as reflecting concerns about the economic and competitive risks of information sharing. CONTEXT: Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading reason for the slow progress. A comprehensive assessment of these issues has not been undertaken for nearly a decade, despite a number of salient legal developments. METHODS: Analysis of federal and state health information privacy statutes and regulations and secondary materials. FINDINGS: Although some legal barriers to HIE persist, many have been ameliorated-in some cases, simply through improved understanding of what the law actually requires. It is now clear that the Health Insurance Portability and Accountability Act presents no obstacles to electronically sharing protected health information for treatment purposes and does not hold providers who properly disclose information liable for privacy breaches by recipients. The failure of federal efforts to establish a unique patient identifier number does slow HIE by inhibiting optimal matching of patient records, but other action to facilitate matching will be taken under the 21st Century Cures Act. The Cures Act also creates the legal architecture to begin to combat "information blocking." Varying patient consent requirements under federal and state law are the most important remaining legal barrier to HIE progress. However, federal rules relating to disclosure of substance-abuse treatment information were recently liberalized, and development of a technical standard, Data Segmentation for Privacy, or DS4P, now permits sensitive data requiring special handling to be segmented within a patient's record. Even with these developments, state-law requirements for patient consent remain daunting to navigate. CONCLUSIONS: Although patient consent requirements make HIE challenging, providers' expressed worries about legal barriers to participating in HIE likely primarily reflect concerns that are economically motivated. Lowering the cost of HIE or increasing financial incentives may boost provider participation more than further reducing legal barriers.

Setting the scene for the future: implications of key legal regulations for the development of e-health interoperability in the EU.

E-health has experienced a dynamic development across the European Union in the recent years and enjoys support from the European Commission that seeks to achieve interoperability of national healthcare systems in order to facilitate free movement. Differences that can be observed between the member states in legal regulations, cultural approaches and technological solutions may hinder this process. This study compares the legal standing of e-health in Denmark, Poland, Spain and the UK, along with key legal acts and their implications. The academic literature review along with an analysis of materials found through the desk study research (reports, legal acts, press articles, governmental web pages and so on) was performed in order to identify aspects relevant to e-health interoperability. The approach to legal regulation of e-health substantially differs by country. So do the procedures that they have developed regarding the requirement for patient's consent for the processing of their data, their rights to access to the medical data, to change the data, data confidentiality and types of electronic health records. The principles governing the assignment of responsibility for data protection are also different. These legal and technological differences must be reconciled if interoperability of European national e-health systems is to be achieved. Copyright © 2016 John Wiley & Sons, Ltd.