What the ONC's Proposed Rule on Information Blocking Means for Your Work

What the ONC's Proposed Rule on Information Blocking Means for Your Work
What the ONC’s Proposed Rule on Information Blocking Means for Your Work June 18, 2019 Daniel Orenstein General Counsel, Health Catalyst
• Introduction • Interoperability • 21st Century Cures Act & Proposed Rule • Examples of Information Blocking Practices • Proposed Exceptions to Information Blocking Practices • Notable Public Comment Themes • How Healthcare Organizations May Be Affected Agenda
© 2018 Health Catalyst Interoperability “The ability of a system to exchange electronic health information with and use electronic health information from other systems without special effort on the part of the user.” The ONC has defined “Interoperability” as: 3
© 2018 Health Catalyst Interoperability Four fundamental features 4 Finding Sending Receiving Text HereUsing/Integrating Interoperability
© 2018 Health Catalyst Interoperability • Automated provision of clinical decision support (CDS) outputs as part of the workflow resulted in a significantly greater likelihood of a clinical intervention.1 • Similar findings for provision of CDS information at the time and location of decision making. • There is an association between availability of CDS and improved quality of care. • Significant benefit in making innovative tools, analyses, and applications available from third party sources. Growing evidence shows substantial treatment and efficiency gains 5 1 Kawamoto, et al, Information in Practice, Mar. 14, 2005.
© 2018 Health Catalyst Interoperability • Significant benefit in leveraging data from other sources—clinical, patient-generated, or socially-based determinants of care. • CDS can help with results such as reduced sepsis mortality, reduced hospital readmission rates, and reduction in unnecessary testing and lab utilization. Growing evidence shows substantial treatment and efficiency gains 6
© 2018 Health Catalyst In addition to CDS, there are many information processing and analysis areas that are not typically performed by an EHR which could be enhanced through third-party systems: • Precision medicine • Population health analytics • Integration of fitness device data • Monitoring and improvement of medication adherence • Chronic disease management • Identification of high-risk and high cost patients • Care coordination Interoperability 7
© 2018 Health Catalyst EHR systems have made great strides, but they have been limited in their ability to integrate with third-party systems. • “EHRs principally show a doctor information she entered previously, but not the wide range of data and services that should drive cost-efficient care and decision making.”1 • The structural paradigm for EHRs to date has been an electronic-based version of the paper encounter documentation. • Factors that are used in evaluating social determinants of care are typically not included in the EHR. • EHRs are provider-centric, and do not include patient-generated content. Interoperability 8 1 Kenneth Mandl, Joshua C. Mandel, Isaac Kohane, Cell Syst. 2015.
© 2018 Health Catalyst • HIEs have had some notable successes at the regional level, but have had challenges finding a sustainable economic model. • Government-conceived efforts haven’t taken solved the interoperability problem: Blue Button, Direct, Trusted Exchange Framework. • Private efforts, such as Commonwell and Carequality, have struggled to make a broad impact. • Lack of national patient identifier has slowed progress. • Information blocking practices have slowed progress. Interoperability Efforts Have Faced Stiff Headwinds 9
© 2018 Health Catalyst What type of organization do you work for? 1. Provider – 36% 2. Payer – 5% 3. HIE – 11% 4. Vendor – 26% 5. Consultant – 24% Poll Question #1 11
© 2018 Health Catalyst The 21st Century Cures Act • The Cures Act is broad and sweeping legislation that covers many topics, mostly on streamlining and accelerating the discovery of new drugs and medical devices. It includes provisions to improve mental health and substance abuse treatment and to improve patient access to new therapies, among many other areas covered by the Act. • The Cures Act also establishes programs and oversight to promote health information interoperability and to prohibit “information blocking” practices. Became law on December 13, 2016 with broad bipartisan support 12
© 2018 Health Catalyst The 21st Century Cures Act “Interoperable” HIT is defined in the Act as HIT that: • Enables the secure exchange of electronic information with, and use of electronic health information from, other HIT without special effort on the part of the user. • Allows for complete access, exchange, and use of all electronically accessible information for authorized use under applicable State or Federal law. • Does not constitute information blocking. The National Coordinator is to develop a “trusted exchange framework” to facilitate health information exchange. • The framework is to include a “common agreement” and establishment of a national provider contact directory. Promotes the interoperability of health information technology (HIT) 13
© 2018 Health Catalyst The 21st Century Cures Act “Information blocking” is defined as any practice that, except as required by law or specified by the Secretary of HHS, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information, and: • If conducted by a HIT developer, exchange, or network, they know or should know that such practice is likely to interfere with, prevent, or materially discourage the access, exchange or use of electronic health information. • If conducted by a provider, the provider knows that such practice is unreasonable and likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. Prohibits “information blocking,” and provides for penalties up to $1M per violation 14
© 2018 Health Catalyst The 21st Century Cures Act • Practices that restrict authorized access, exchange, or use under applicable State or Federal law of information for treatment and other permitted purposes, including transitions between health information technologies. • Implementing HIT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging or using EHI. • Implementing HIT in ways likely to: • Restrict access, exchange, or use of EHI with respect to exporting complete information sets or in transitioning between HIT systems. • Lead to fraud, waste, or abuse, or impede innovations and advancements in health information access, exchange, and use, including in care delivery. Information blocking practices that are prohibited 15
© 2018 Health Catalyst The 21st Century Cures Act • HHS is to identify “reasonable and necessary activities” that do not constitute information blocking. • No enforcement of actions earlier than 30 days after enactment of the Cures Act. Requiring establishment of regulatory exceptions 16
© 2018 Health Catalyst The 21st Century Cures Act Any information blocking complaint received by ONC which might identify the source: • Shall not be disclosed by ONC except as necessary to carry out the information blocking provisions. • Shall be exempt from FOIA disclosure. • May be used by the FTC IG for reporting if the source is protected. Information blocking complaints to be protected from disclosure 17
© 2018 Health Catalyst On March 4, 2019, HHS published the Proposed Rule implementing the Cures Act provisions on interoperability, information blocking, and the use of APIs. The Proposed Rule 18 • 60 day comment period, extended to 90 days. The Proposed Rule: 1. In the preamble, provides a detailed discussion of examples of information blocking practices. 2. Provides for seven exceptions to the prohibition on information blocking. 3. Requires the provision of APIs as condition for certification for electronic health information technology.
© 2018 Health Catalyst How much does information availability and exchange affect your organization’s effectiveness? 1. No impact – 2% 2. Some impact – 14% 3. Moderate impact – 21% 4. High impact – 41% 5. Significantly impairs effectiveness – 21% Poll Question #2 19
© 2018 Health Catalyst Examples of Information Blocking Practices Five categories: 1. Restrictions on Access, Exchange, or Use 2. Limiting or Restricting the Interoperability of Health IT 3. Impeding Innovations and Advancements in Access, Exchange, or Use of Health-IT-enabled Care Delivery 4. Rent-seeking and Other Opportunistic Pricing Practices 5. Non-standard Implementation Practices Examples start on page 364 of the PDF version 21
© 2018 Health Catalyst Examples of Information Blocking Practices Examples: • A health system requires staff to obtain patient written consent before sharing patient’s EHI with unaffiliated providers, even though this is not required by HIPAA or state law. • An EHR vendor sues to prevent a clinical data registry from providing interfaces to physicians who use the developer’s EHR to submit EHI to the registry, claiming that the registry infringes the vendor’s copyrights in its database that incorporate data mappings that reference table headings and rows of the EHR database in which EHI is stored. • A vendor that allows third party developers to use its platform requires that third party developers to grant rights in their source code to the vendor. Category 1 – Restrictions on Access, Exchange, or Use 22
© 2018 Health Catalyst Examples of Information Blocking Practices Examples: • A hospital configures its EHR so that users cannot easily send referrals and EHI to unaffiliated providers. • An EHR vendor prevents (e.g., by imposing high fees) third-party clinical decision support (CDS) app from writing EHI to the EHR, when a provider has authorized it. • Providers selectively disabling EHR functionality that allow transmission of EHI to third parties, or take steps to delay transmissions. Category 2 – Limiting or Restricting the Interoperability of Health IT 23
© 2018 Health Catalyst Examples of Information Blocking Practices Examples: • An EHR vendor requires third party applications to be reviewed for security before use but delays the review or conducts it in a discriminatory manner. • EHR vendor will not provide technical documentation to a systems integrator engaged by a provider unless the systems integrator signs a broad non-compete that prohibits them from working with other vendors. • A health IT vendor discourages customer from getting data integration capabilities from a third party claiming it will have that functionality soon. In reality the capabilities it is developing are more limited and 12-18 months from being in production. Category 3 – Impeding Innovations and Advancements in Access, Exchange, or Use of Health-IT-enabled Care Delivery 24
© 2018 Health Catalyst Examples of Information Blocking Practices Examples: • An analytics company’s services to provider customers include de-identifying EHI and combing it with other data to identify areas for quality improvement. The customer’s EHR vendor demands a percentage of revenue from the analytics company’s services in excess of its reasonable costs in exchange for access to data in the EHR. • An EHR vendor charges more to export or use EHI when a provider is transitioning to competing technology or trying to export data for use with an HIE. Category 4 – Rent-seeking and Other Opportunistic Pricing Practices 25
© 2018 Health Catalyst Examples of Information Blocking Practices Examples: • An EHR vendor implements the C-CDA for receiving transition of care summaries but only sends them in a proprietary or obsolete format. • A health IT vendor uses the “required” portions of a widely adopted industry standard but implements proprietary standards wherever it has discretion, even when standard formats are available. Category 5 – Non-standard Implementation Practices 26
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may engage in practices that are reasonable and necessary to prevent physical harm to a patient or other person. Conditions: • Must have a reasonable basis to believe that its practice will directly and substantially reduce the likelihood of harm to a patient. • Must have adopted a policy that addresses patient harm or make case by case findings that a disclosure of EHI could result in patient harm. Comments: This exception is broad, could be applied subjectively with wide variation, and could be misused. Exception 1: Preventing Harm 28
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may engage in practices to protect the privacy of EHI. Conditions: • Must demonstrate a basis for its actions in HIPAA or other privacy laws. • Must be tailored to the specific privacy risks addressed, and implemented in a consistent and non-discriminatory manner. Comments: This exception is broad, could be applied subjectively with wide variation, and could be misused. Exception 2: Promoting the Privacy of EHI 29
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may implement measures to protect the security of EHI. Conditions: • Must be tailored to the specific measures necessary to protect the security of EHI, and implemented in a consistent and non-discriminatory manner. • If the organization has a security policy, it must be consistent with a widely accepted framework and meet other criteria. • If the organization does not have a policy, it must make case by case determinations on whether its practices are necessary to protect the security of EHI. Comments: This exception is broad, could be applied subjectively with wide variation, and could be misused. Exception 3: Promoting the Security of EHI 30
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may charge for costs it reasonably incurs. Conditions: • Must use objective and verifiable criteria, uniformly applied. • Must be reasonably related to vendor’s cost of access, exchange, use of EHI. • Must be allocated among all customers. • May not be based on whether requestor is a competitor, or sales, profit, revenue of requestor. Comments: Reasonable cost is hard to verify and can be very subjective. Exception 4: Recovering Costs Reasonably Incurred 31
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may decline to provide access, exchange, or use of EHI if infeasible. Conditions: • Must use objective and verifiable criteria, uniformly applied. • Must demonstrate substantial burden to making EHI available, assessing multiple factors, including whether it provides comparable access to others, whether other sources are available for the EHI. • Must respond to all requests and provide denials in writing. Comments: The decision to deny access, including evaluation of the facts and circumstances, is highly subjective. Exception 5: Responding to Requests That Are Infeasible 32
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization (e.g., EHR vendor) can claim IP rights, but it must license interoperability elements. Conditions: • Must respond to a request to license IP to enable access to EHI within 10 days. • Must offer a license on reasonable and non-discriminatory terms. • The license must have a broad scope including product development and marketing, ability to offer interoperable products. • No restrictions such as non-competes, requirement to license back IP, exclusivity. Comments: Wide latitude to organizations to decide if their interoperability elements include IP. Exception 6: Licensing of Interoperability Elements 33
© 2018 Health Catalyst Exceptions to Information Blocking Practices Description: An organization may make technology temporarily unavailable to perform maintenance. Conditions: • Technology must be unavailable no longer than necessary to perform the maintenance. • Must be implemented in a consistent and non-discriminatory manner. Comments: This exception reflects common sense and is unlikely to be controversial. Exception 7: Maintaining and Improving Health IT Performance 34
© 2018 Health Catalyst Timing • Need more time. • Should be finalized ASAP. Notable Public Comment Themes 36
© 2018 Health Catalyst Definition of EHI • Expand to include other/more information. • Restrict to manageable standard (e.g., USCDI). Notable Public Comment Themes 37
© 2018 Health Catalyst Innovation • More data sharing increasing innovation. • Oversharing suppresses innovation. Notable Public Comment Themes 38
© 2018 Health Catalyst Unintended Consequences • Open-ended rules will perpetuate information blocking. • Open-ended rules impose too high a burden on recipients of requests for EHI. • “Transformed” data made available at cost. Notable Public Comment Themes 39
© 2018 Health Catalyst Cost Recovery • Reasonable cost method represents unlawful cost caps, and free market should decide. Allow for profits. • Cost recovery is appropriate for sharing of EHI. Notable Public Comment Themes 40
• Introduction • Interoperability • 21st Century Cures Act & Proposed Rule • Examples of Information Blocking Practices • Proposed Exceptions to Information Blocking Practices • Notable Public Comments • How Healthcare Organizations May Be Affected Agenda
© 2018 Health Catalyst How would you describe your organization’s readiness to comply with the Cures Act interoperability and information blocking provisions? 1. Familiar with the requirements but have not prepared to comply – 54% 2. Outlined steps needed to comply – 18% 3. Ready to comply now or within 6 months – 29% Poll Question #3 42
© 2018 Health Catalyst • It’s going to take awhile. The comments need to be considered and the final rule needs to be written. • But it may not be as long as some other regulations given the urgency expressed by ONC. • The requirements may change. Things to Consider When Preparing for the Final Rule on Information Blocking 43
© 2018 Health Catalyst • Will your organization be directly covered by the final rule? • Consider where requests for EHI may come from. • Or consider from whom you will request EHI. • Is your database architecture set up to implement the likely standards? (FHIR, APIs, USCDI) And what are the likely gaps? • Who can help you? Things to Consider to Start Preparing 44
© 2018 Health Catalyst Sept. 10-12, Salt Lake City, Grand America Hotel • National Keynotes • Digital Innovation Showcase • 28 Educational, Case Study, and Technical Breakouts • 24 Analytics Walkabout Projects • Machine Learning Marketplace • Networking (bringing back ”Braindate”) • CME Accreditation for Clinicians • 5-Star Grand America Hotel Experience • 96 Total Presentations Healthcare Analytics Summit 19 45
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