Health Data and Information Series #3
Introduction
Health information exchange (HIE) is already an indispensable part of the healthcare infrastructure in New York. But HIE will become even more important as technological and policy developments expand the ways in which health data and information can be integrated and used to improve access to and quality of healthcare services and control healthcare costs. Progress has been made over the years, but much remains to be done in expanding the types of clinical and related information included in New York’s healthcare information infrastructure, promoting the interoperability of disparate data systems, which depends on the consistency and standardization of data, and aligning New York’s information infrastructure with the goals of the evolving federal landscape.
This is the third in a series of papers by the Step Two Policy Project discussing aspects of health data and information. In our Policy Brief titled Democratization of Data, Information, and Policy Analysis, we discussed how other states, especially Massachusetts, have created a roadmap for reporting data and information about the healthcare delivery, payment, and insurance coverage systems to assist government officials and external analysts in the development of healthcare policy. In our Issue Brief titled Categories of Health Data and Information, we described various sources for health-related information and defined four distinct categories of health data and information. These categories are comprised of health data and information relating to:
the healthcare delivery and payment system, as captured through service delivery, claims, payment models, insurance coverage, and health system financial reporting
patients, providers, and populations served by specific providers or payers, as captured through clinical encounter health information systems such as electronic health records and health information exchange networks
public health and health-related social needs for general populations, as captured through public health reporting, health-related human services reporting, and public surveys; and
consumer-facing, consumer empowerment platforms such as those related to price transparency, individual cost-sharing, and provider accessibility.
By better integrating clinical data systems, standardized quality measures, and administrative data (e.g., claims and admissions data), New York can develop a comprehensive health data infrastructure serving patients and providers that more effectively:
coordinates the delivery of care
improves quality and health outcomes
provides insight into the cost of care relative to health outcomes
provides timely data and information for identifying and addressing public health challenges, and
enables the management of specific populations – whether to support value-based payment initiatives or to focus on improving health equity, or both.
This Issue Brief focuses primarily on New York’s HIE “network of networks,” the Statewide Health Information Network for New York (SHIN-NY) and the State’s All Payer Database (APD), which are two of the most important aspects of the first and second categories of health data and information described above. The purposes of this Issue Brief are to improve the general understanding of the issues involved in this area, describe the initiatives either underway or planned to modernize the related processes, and make recommendations about strategic decisions the State faces that will impact the effectiveness of HIE.
Background on HIE and the SHIN-NY
The backbone of a health data infrastructure comprises HIE to support timely clinical care when caring for individuals or addressing public health, coupled with administrative data contained in the APD to support retroactive financial and population-wide analyses. In 2010, New York established the SHIN-NY. The network is composed of six regional health information organizations called Qualified Entities (QEs). The SHIN-NY's mission is to facilitate the “electronic exchange of clinical information and connect healthcare professionals statewide.”[1]
The New York State Department of Health (DOH) identified the New York eHealth Collaborative (NYeC) as the state-designated entity responsible for overseeing and managing the SHIN-NY. NYeC is a nonprofit organization with a board of directors composed of representatives of private healthcare organizations from across New York and does not include governmental appointees. NYeC is a public-private partnership: a private organization that plays a vital role in the implementation of public policy. It works closely with DOH to lead, coordinate, and administer the SHIN-NY through the development of policies, operation of statewide technology, and promotion of standards and workflows, while fostering innovation and conducting analyses, with the goal of making the SHIN-NY “an integral tool to transform the healthcare system and make lives better.”[2] Virtually all the funding for the operations of the SHIN-NY comes from State grants, a majority of which is State-directed federal funding.
The most straightforward description of an HIE is that it collects, stores, and manages the secure and confidential exchange of clinical data from electronic health records, laboratory systems, and/or other clinical information systems. An “exchange” is necessary because these types of data are held within siloed databases. Moreover, other siloed databases that may not be connected to the HIE contain information that would be useful if it could be integrated into a single profile for an individual or a population subset. These other databases include healthcare administrative data like claims, payment, and admissions/visits; behavioral health; health-related human services and housing; criminal justice; workforce, and education, among others.
A foundational challenge to producing better information from New York’s health and health-related data is that each one of these silos is subject to statutes, regulations, policies, and customary practices related to the collection, use, and sharing of information. As a result, discussions in New York to restructure the collection and information exchange processes of the SHIN-NY inevitably raise substantive issues about the nature of the data to be shared, boundaries over who can access the data, and the technology infrastructure and regulatory framework to make all this happen.
The evolution of the healthcare delivery system since the establishment of the SHIN-NY, as well as the evolution in health information technology, make it imperative that New York modernize its HIE infrastructure. This will be a multi-year effort, but fortunately, DOH and NYeC have been working on a number of initiatives that will increase the usefulness of the SHIN-NY for patients, providers, and policymakers.
Patient-Specific Use of Health Data and Information
Currently, the SHIN-NY contains patient-specific clinical information transmitted from hospitals and other participating clinical providers to the six regional HIEs, i.e., the QEs that comprise the SHIN-NY network. The QEs enable participating healthcare providers, with patient consent, to access electronic health information and securely exchange data statewide. The core benefit of the SHIN-NY is that it enables multiple healthcare providers who are interacting with the same patient, but potentially in different healthcare systems and using different electronic health record platforms, to coordinate the care of an individual by sharing patient information and reducing the duplication of tests and procedures, thereby both improving care and lowering costs.[3] The SHIN-NY’s mission, as described in the Privacy and Security Policies and Procedures for Qualified Entities and their Participants in New York State under 10 N.Y.C.R.R. § 300.3(b)(1),is “to improve the quality, coordination and efficiency of patient care, reduce medical errors and carry out public health and health oversight activities, while protecting patient privacy and ensuring data security.”
To effectively support care decisions, it is essential that information accessed by clinicians through the SHIN-NY be timely, reliable, and actionable. Ideally, the health information exchange enables clinical data to be integrated into existing clinician workflows, rather than just providing information in a separate document format or in a separate application.[4] While there may be some benefit in the form of regional expertise related to community needs, the current SHIN-NY infrastructure in New York, composed of six separate, regional QEs, is hampered by the inherent variability of this type of distributed model. This variability, in some cases, creates a lack of alignment and consistency because of the different standards under which the data is being collected and shared. One purpose of a package of proposed regulatory amendments to the governance of the SHIN-NY which are discussed further below, is to reduce this variability.
HIE in Population Health Management and the Role of the All Payer Database
In addition to enabling the exchange of patient-specific clinical data, a well-functioning HIE infrastructure can also produce timely practice and provider performance data for specific sets of utilization and clinical quality measures. This aggregation of information enables clinicians to better identify trends in their practice compared to looking separately at disparate reporting from multiple data sources.[5] This functionality is critical to a variety of applications of population health management, such as supporting value-based care arrangements for an attributed population and addressing health equity issues by comparing disparities in health outcomes between populations with similar health conditions. This functionality is an essential part of the State’s strategies of expanding alternative payment methodologies and supporting global budgeting at the regional and health system level, improving health equity, supporting various public health initiatives, and implementing policies related to statewide or regional emergency response.
Coordinating patient-level clinical data from the SHIN-NY with service utilization and clinical quality measures in a broad way requires integration of HIE data with data from the State’s APD. Clinical EHR data can augment quality measures that are associated with coding data included in claims, and vice versa, leading to improved consistency in quality measurement. The APD was authorized in Public Health Law in 2011 in order to address the “complexities of the health care system as well as lack of comparative data on how services are accessed, provided, and paid for.”[6]
Although the APD was authorized in 2011, it wasn’t until 2016 that a vendor and regulations were in place and implementation began. After years of intensive development efforts, work on the State-facing as well as public-facing infrastructure continues, although the status remains somewhat opaque to outside observers. The last time DOH held an All Payer Database Stakeholder Forum was on October 16, 2019, despite the fact that these forums were the primary vehicle for non-DOH State and external stakeholders to receive updates on APD progress, status, and future plans, as well as for the DOH to engage with and receive feedback from forum participants. The COVID-19 pandemic certainly interrupted the scheduling of these meetings; however, given that many similar types of convenings have been reestablished in recent years, it is important to reestablish the stakeholder interaction and transparency related to this important initiative.
As its name implies, the APD is intended to capture a wide range of data, drawing on sources including:
… hospital discharge data (SPARCS), vital statistics mortality data, Qualified Health Plan (QHP) enrollment and encounter data, Medicaid Managed Care (MMC) enrollment and encounter data, Essential Plan (EP) enrollment and encounter data, Child Health Plus (CHP) enrollment and encounter data, Medicaid Fee-for-Service (FFS) and Medicare Fee-for-Service data. The integration also includes Provider Network Data System (PNDS) and other provider data. In 2020, the APD began collecting data from commercial off-exchange health plans on a mandatory basis, and from self-funded commercial health plans governed by the Employee Retirement and Income Security Act of 1974 (ERISA) on a voluntary basis.[7]
Most states that aspire to aggregate this range of data call their system the All Payer Claims Database. New York’s system is called the APD because it has always planned to collect data from sources other than “claims.” The slides from the October 16, 2019, APD Stakeholder meeting include a graphic depicting “Connecting Data Over Time.” This graphic is helpful in communicating the plan, but it is unclear whether the planned and future data additions have yet occurred.
Connecting to at least some of the data sources of the APD, as identified above, may still be an aspirational goal. While the APD website indicates they began collecting data in 2020 from commercial off-exchange plans on a mandatory basis, DOH has not communicated whether Medicare Advantage plans are now also included, nor the extent to which ERISA plans are voluntarily submitting their data to the APD. This leaves a significant percentage of covered lives,[8] potentially unrepresented in the APD. Nevertheless, as of November 2019, the APD included data on approximately 10-11 million individuals.[9]
In addition to the likely gaps in claims data, it is also likely that the other DOH registries and the SHIN-NY EHR data, assessment data, survey data, and social determinants data that are planned for “future/TBD” connection are also yet to be incorporated. These limitations impact the depth and breadth of analyses that the APD can currently support. This is especially important as New York pursues global budget models for care, which require comprehensively managing all aspects of care for the attributed lives. It would be useful if the DOH were to return to hosting the stakeholder meetings to both communicate their progress and challenges and to also hear from stakeholders about their evolving data and information needs.
One of the most challenging aspects of the APD relates to cost and price transparency. This issue has been challenging both from a technical and a stakeholder perspective. The important issue is whether providers are required to report the “allowed amount” from the insurer or simply the “charge” amount from the provider, of a claim. Provider claims for payments by insurance plans in their network include both the “charge” amount (which is a list price that almost no one pays) and the “allowed” amount, which is the much lower, contractually agreed upon price between the provider and the plan. Providers and plans regard the contractual “allowed” amount to be proprietary and are highly sensitive about its disclosure. However, the allowed amount is most useful in terms of analyzing the cost of various procedures from both a consumer and a policymaker perspective.
While healthcare providers and insurance companies resist transparency of pricing information, consumer advocates and purchasers of health services, in general, have long demanded this information as a means of empowerment in preparing for and making healthcare decisions. The APD has the statutory authority to collect the “post-adjudicated claims data” payment information[10] (of which the “amount paid” in the graphic below, is a portion), and with the federal rules that became effective January 1, 2021, that hospitals, “… provide clear, accessible pricing information online about the items and services they provide…,”[11] perhaps the APD will be able to produce more detailed information regarding healthcare costs and prices.
The following figure identifies the payment data[12] that was stored in the APD as of 2019:
Although much of the work DOH has been doing on the APD is only available within DOH and other State agencies, the public-facing component of the APD, the NYS Health Connector, currently includes a handful of trackers and dashboards that are more accessible to general users than the public data sets on the Health Data NY website. The NYS Health Connector dashboards are designed to illuminate a number of healthcare issues of general interest, such as service utilization, estimated costs[13] (as calculated from SPARCS hospital discharge data and hospital Institutional Cost Report data), public health information, and quality.[14]
DOH has also been focusing on quality measurement and aligning with the work being undertaken at the National Committee for Quality Assurance (NCQA) to convert all of their Healthcare Effectiveness Data and Information Set (HEDIS) measures into “digital quality measures.” DOH’s Health Information Technology Enabled Quality Measurement Roadmap, reproduced below, shows the value of the integration between the APD’s data and information and the data and information contained in clinical systems, in better caring for the health of specific populations, as well as for managing conditions such as diabetes, hypertension, or pregnancy.
Use of the SHIN-NY to Support Public Health
The SHIN-NY supports public health initiatives in a variety of ways. These include public health reporting, monitoring disease trends, conducting outbreak investigations, responding to public health emergencies, assessing comparative effectiveness of medical treatments, conducting adverse drug event reporting, and informing new payment reforms.[15] These purposes can be engaged in without affirmative patient consent.
In 2015, then the NYS Health Commissioner Nirav Shah, along with colleagues from New York and Massachusetts, discussed the “revolutionary” potential of EHRs and health information networks (such as the SHIN-NY) in transforming public and population health management. In their paper titled, Uses of Electronic Health Records for Public Health Surveillance to Advance Public Health, the authors write:
EHRs provide an opportunity to streamline and improve current surveillance practices. Their use could greatly improve the reporting of nonlaboratory diagnosed diseases as well as the collection of treatment and risk factor data, so long as these data are entered in the EHR. … EHRs could be used to greatly enhance surveillance for chronic diseases. They have the potential to expand the purview of routine surveillance to include obesity, asthma, diabetes, heart disease, and cancer at little marginal cost per condition. They can also provide rich data on health care utilization, treatment patterns, and outcomes that are currently very difficult to assess with routine surveillance methods. Finally, EHRs provide multiple opportunities for greater integration of public health and clinical health by enhancing information sharing in both directions.
During the COVID-19 pandemic, some states used their HIEs for public health reporting of infections and vaccinations, as well as for health facility information such as the number of ventilators or the amount of personal protective equipment available. Leveraging HIE in this way was possible because of the existing IT infrastructure and users at the hospitals.
During the COVID-19 pandemic in New York, the SHIN-NY was leveraged, in part, to provide insight into the clinical and demographic information of COVID-19-positive patients for both State and local health departments.[16] For example, in addition to lab test result data to facilitate patient notifications and contact tracing, information contained within the SHIN-NY, such as details on hospitalizations of current and previous COVID-19 patients and information on potentially relevant co-morbidities, was used to help State and local officials better understand the virus, support plans of action, and develop protocols for patient care and community protection.[17]
Enhancing the Organizational Structure and Function of the SHIN-NY
There continues to be untapped potential with the SHIN-NY. Enhancing its ability to produce meaningful, statewide health data and information across sectors would enable all types of providers connected to the SHIN-NY to operate with greater visibility into their patients’ and populations’ health and health-related conditions. State policies play a significant role in the extent to which HIEs are able to achieve these high levels of functionality.
David Horrocks,[18] who has been the CEO of NYeC since 2022, has written extensively about HIEs. He and his academic colleagues have written about the methods that states use to organize and promote HIEs.[19] Their work identifies four general categories of state HIE organizational structures, and they include a fifth category for states that are transitioning between types. The four broad categories are defined as: 1) public-private utilities, 2) orchestrators, 3) state run services, and 4) private sector promoters. The descriptions of these categories are included in the graphic below:
Horrocks, et al., Methods States Use to Organize and Promote Health Information Exchange
New York’s SHIN-NY is in the “orchestrator” category. It follows the “distributed HIE approach” which is “more common in states with large populations and geographies.…”[20] As Horrocks and his co-authors explain, New York and the other large orchestrator states (Massachusetts, Pennsylvania, and Texas) had existing regional HIEs in place when the federal Health Information Technology for Economic and Clinical Health (HITECH) Act was implemented as part of the American Recovery and Reinvestment Act in 2009. The HITECH Act included approximately $35 billion in funding[21] to increase the adoption of health information technology in the form of both electronic health records and health information exchanges. HITECH provided incentive payments to Medicare and Medicaid providers in health sectors for the “meaningful use”[22] of certified EHRs, established standards for EHRs related to the ability to transmit specific common clinical data, strengthened health data and information privacy rules, and promoted the development and use of public health registries, among other actions.[23]
The following figure from Assessing HITECH Implementation and Lessons: 5 Years Later, published in 2016, is a helpful visualization of the goals of the HITECH Act and how the various focus areas and contexts of health information exchange are woven together in pursuit of those goals:
Abbreviations: REC, Regional Extension Center; HIPAA, Health Insurance Portability and Accountability Act of 1996; CMS, Centers for Medicare and Medicaid Services; HHS, US Department of Health and Human Services; NwHIN, Nationwide Health Information Network. Italics = HITECH and related initiatives. a Authors’ construct, building on Blumenthal3 for the core framework, Gold and colleagues1 for drivers of HER adoption, and HIE, and Ricciardi and colleagues6 for the aims of consumer engagement. Color added.
Given how much State government tends to avoid creating “winners and losers” from its policy decisions, it is not surprising that New York chose to pursue the orchestrator model for the SHIN-NY in order to support all of the existing players and progress already in place. This policy decision, as well as several others described below, has shaped the course of the SHIN-NY’s evolution. Although there may be benefits from a distributed approach, such as regional focus, the “orchestrator” model makes it harder to implement functionality with statewide implications. As Horrocks explains:
[R]egarding public health services, states with multiple HIEs are likely to find a distributed model more complicated to leverage. For instance, a single statewide Master Person Index (MPI) can be used to combine clinical data with public health registries, to enhance the resulting public health dataset. When that data exists in multiple source systems, such a capability will be more challenging to implement.[24]
The QEs have minimum core services technical requirements[25] such as statewide patient record look-up, notifications and alerts, secure direct messaging, consent management, provider and public health clinical viewers, and lab results delivery. They also have a required set of core services. These currently include legal and participation agreements, marketing and recruitment services, participant adoption of access and use support services, participant training, user support services, and stakeholder involvement.[26] The core services are provided at no charge. For a fee, however, the QEs also offer other services for their regional participants.
In addition to the public health and population health challenges that derive from New York’s “distributed” HIE operating model, there are several other policy decisions that impact HIE uptake and functioning. Ari Bronsoler, et al., in their paper, The Role of State Policy in Fostering Health Information Exchange in the United States,[27] identify twelve dimensions of state policies that impact health data and information sharing. These dimensions fall into four categories:
Clarifying HIE governance
Strengthening financial stability
Specifying uses and users of an HIE, and
Protecting the underlying data.
One of the most important of these policy decisions is whether and when patients need to consent to their data being exchanged over the HIE. According to Bronsler, “… enacting legislation that has patients participate by default leads to a 16% increase in usage.”[28] These participation-by-default policies are referred to as “opt out” policies. New York has an “opt in” consent model, meaning that patients must provide “affirmative consent” for the non-emergency sharing of their health data. The existing consent model and the distributed operating model of New York’s HIE represent barriers to the most effective utilization of the SHIN-NY in the care of individuals and in population health management.
Proposed Regulatory Amendments Governing the SHIN-NY
New York is now seeking to reshape important aspects of the SHIN-NY that seek to address some of the drawbacks of New York’s distributed model. Proposed amendments to the applicable regulations were filed in the State Register on February 14, 2024, and the text is available on the DOH website. As Jeff Kraut, the Chair of the Public Health and Health Planning Council (PHHPC), said in the meeting where the proposed regulations were presented, “… we never would have built the system we have today, knowing what we know today.”[29] The proposal establishes a set of common rules for all of the QEs that will better support patient care, health reform, and public health initiatives.
In the documents accompanying the proposed regulations, DOH states, “[B]y clarifying the data reporting and aggregation responsibilities applicable to the qualified entities, the proposed amendments will transform the SHIN-NY into a functional resource for the analysis and reporting of statewide health information for authorized public health and health oversight purposes.”[30] Specifically, the proposed regulations will establish:
A common statewide participation agreement to be used by every QE and every SHIN-NY participant[31], eliminating the variability in terms, processes, and technology that currently exists,
A statewide data infrastructure that will be used to:
exchange data among SHIN-NY participants,
match individual demographic information submitted by SHIN-NY participants in order to create a master patient index,
create a statewide provider directory in order to create a master provider index,
create a statewide consent management system, and
aggregate SHIN-NY participants’ data in a statewide repository,
The ability for a healthcare facility to connect directly to the SHIN-NY data infrastructure, assuming sufficient technical capacity, without a QE intermediary, and
A statewide consent process for patients that is not specific to a particular QE, enabling clear authorization to access information across regions and across networks.[32]
Taken together, these proposed changes would address most of the drawbacks of a distributed model. If adopted, these regulations will significantly increase the ability of the SHIN-NY to support healthcare delivery and innovations in New York. The proposed amendments will increase interoperability, align the state’s processes with current information technology capabilities, better support the strategic goals of the recently approved Medicaid 1115 waiver, and make the SHIN-NY integrate more effectively with the evolving federal landscape. The amended regulations will also facilitate more efficient emergency reporting for healthcare facilities compared to the ad hoc emergency procedures that are implemented with the State’s Hospital Emergency Reporting Data System (HERDS). HERDS was used extensively throughout the COVID-19 pandemic, as well as during other urgent or emergent response activities over the years.
The proposed amendments also represent significant progress with respect to consent policies. The State will not be adopting an opt-out consent model, but the proposed amendments will at least move to a statewide consent policy. Among the most important impacts of these amendments will be the ability of entities to deliver their data directly to the SHIN-NY, without having the QEs as the intermediary. This will reduce local variability in data and increase the potential for creating comprehensive, statewide master patient and provider indices that facilitate public health and population health management activities.
Data Sharing Agreements
One peer state activity that New York could take note of is the work being done in California called the Data Exchange Framework, which is one of the initiatives of California’s Center for Data Insights and Innovation. The Data Exchange Framework, “… includes a single data sharing agreement (DSA) and common set of policies and procedures that will govern and require the exchange of health information among health care entities and government entities in California.”[33] The DSA is a mandated agreement between hospitals, physician and other medical groups, skilled nursing facilities, health plans and disability insurers, clinical laboratories, and acute psychiatric hospitals, “to share patient information safely.” California’s vision is that “[E]very Californian, no matter where we live, should be able to walk into a doctor’s office, a county social service agency, or an emergency room and be assured health and human services providers can access the information they need to provide safe, effective, whole person care—while keeping our data private and secure.”[34] It will be valuable to examine California’s implementation and learn from their experience.
Other states as well, are seeking to expand and streamline memorandums of understanding and data sharing policies and procedures. Both Connecticut and Massachusetts have been working on inside government enterprise data sharing agreements in an effort to liberate data and information from government agency silos.
Appendix A describes models of HIE organizational structure and function from other states.
Another important initiative in strengthening health information exchange in New York is the alignment of the SHIN-NY and APD with the recent federal legislation and regulations. These developments at the federal level are designed to improve patient access to their own health information, ensure secure and seamless data sharing among healthcare providers, and advance the integration of EHRs. The intent of the new federal regulations is to address the issue of privacy and patient consent, aiming to balance patient confidentiality with the importance of sharing important health information for care coordination and treatment.
Federal Developments Impacting HIE and Access to Healthcare Data in New York
These federal developments directly affect health information exchange in New York and the ability of patients to access their own health records. As such, they are a critically important part of New York’s health data and information infrastructure. These new federal developments are described below.
The 21st Century Cures Act
The 21st Century Cures Act (the “Cures Act”) was signed into law in 2016. It is broad legislation that includes measures designed to promote research related to the prevention and cure of serious disease, accelerate drug and medical device development, address the opioid crisis, and expand mental health services. The Cures Act also includes provisions that seek to improve the interoperability of health information technology, prevent providers from “blocking” access to health data to ensure that patients have access to their own data, and increase the adoption of EHRs.[35] The Office of the National Coordinator for Health Information Technology (ONC) is in charge of implementing the interoperability and information blocking (i.e., patient access) provisions.
TEFCA Provisions Promoting Interoperability Among HIEs
To implement the interoperability provisions, the ONC was directed to, “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.”[36] The goal is to create a standardized approach for data exchange, making it easier to share health information securely and efficiently. The Trusted Exchange Framework and Common Agreement (TEFCA) outlines a common set of principles and, through the support of the “Recognized Coordinating Entity,” developed a Common Agreement of minimum technical and legal requirements for health information networks (HINs) when sharing health data network-to-network. The Agreement went live in December 2023. The Common Agreement will continue to evolve in response to stakeholder feedback and information technology developments. TEFCA is currently voluntary, but it is likely that stakeholders will gravitate towards standards as they become the key components of seamless integration.
Limitations on Information Blocking
The Cures Act also addresses information blocking. Information blocking includes practices that “unreasonably” constrain the access, exchange, or use of electronic health information. The ONC has now established clear standards for health IT developers of certified health information technology, HINs and HIEs, and healthcare providers. The underlying premise of the provisions included in the Cures Act is that patients are entitled to access their own electronic health information at no cost and in a convenient form. The legislation sets out penalties for actors that engage in information blocking and establishes some exceptions under which information blocking is not considered unreasonable.
The ONC Health IT Certification Program (HTI-1) rule updates required by the Cures Act are meant to implement the legislative provisions related to EHRs and support the information blocking regulations. The rule introduces new and revised standards that health IT developers must meet to ensure their products support seamless and secure access, exchange, and use of electronic health information (EHI). It aims to prevent information blocking and improve software quality, thereby enhancing patient access to health data and enabling better outcomes.
The Patient Access and Interoperability Rule
Another important development in the federal health data and information landscape is the Centers for Medicare & Medicaid Services (CMS) Patient Access and Interoperability Rule published in May 2020. This rule aligns with provisions in the Cures Act to ensure that patients have easy access to their EHI and to improve data exchange and care coordination across the healthcare delivery system. The Patient Access and Interoperability Rule applies only to health information from CMS-regulated payers, e.g., Medicare Advantage, Medicaid, Children's Health Insurance Program, and Qualified Health Plan issuers on the Federally Facilitated Exchanges.
Federal Changes to SUD Privacy Regulations in 42 CFR Part 2
In addition to the provisions in the Cures Act and in the Patient Access and Interoperability Rule, there are changes from HHS to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (“Part 2”), which address the privacy of patients’ SUD treatment records. The changes, which are effective April 16, 2024, but have a compliance window until February 16, 2026, aim to better align these regulations with the Health Insurance Portability and Accountability Act (HIPAA) and with HITECH. The new rule simplifies patient consent requirements, allowing a single consent, as occurs with HIPAA, to cover all future uses and disclosures for treatment, payment, and healthcare operations. The changes also permit HIPAA-covered entities and business associates that receive records under this consent to redisclose the records in accordance with HIPAA regulations. Additionally, the changes permit disclosure of records without patient consent to public health authorities, provided that the records disclosed are de-identified, according to the standards established in the HIPAA Privacy Rule.[37] These changes are significant in terms of coordinating care records of all types into a comprehensive, cross-sector view of an individual, rather than segregating SUD records, as was required before the rule change.
Implications of Federal Actions
Together with the federal requirements related to price transparency from 2021 referred to earlier, the provisions in the Cures Act, the Patient Access and Interoperability Rules, and the changes to the Part 2 regulations described above, represent a significant shift in health information exchange and facilitate the ability of patients to access their own health data in a free and convenient manner using applications of their choice, as well as to gather information about the prices of hospital services. These changes in the federal health data and information ecosystem also facilitate the sharing of standardized health data and information between HIEs and HINs, leading to more robust data for public health and population health management purposes.
The Recognized Coordinating Entity for TEFCA, The Sequoia Project, describes many of the benefits of TEFCA for various healthcare-related stakeholders. Many of the federal actions relate to the data and information itself, while TEFCA focuses on creating consistent policies and technical approaches to the exchange of that health information. The stakeholder benefits related to expanded health information exchange and efficient data
sharing with TEFCA magnify the existing use cases and benefits from HIE discussed throughout this Issue Brief. These range from patients not needing to endure duplicate, unnecessary procedures; patients no longer needing to be the couriers of their health data and information between healthcare providers; to the improved sharing of public health and preparedness data between states, localities, and healthcare providers; to improved care coordination for individuals and care of populations, for example, those with diabetes or hypertension or those experiencing disparities in health outcomes.
Conclusion
While New York and other states have demonstrated a commitment to enhancing health data and information integration and exchange, it's important to recognize significant challenges remain, and there are sectors within healthcare that remain on the margins of these activities. Addressing these issues and gaps is crucial for ensuring that all aspects of patient care, especially those serving vulnerable populations, are fully integrated into the broader health information exchange ecosystem, advancing the goal of comprehensive, whole-person care and public health and population health management.
Funding to support HIE in New York, such as the HEAL NY grants and the HITECH Act, was primarily focused on hospitals and physician practices, leaving out behavioral health providers, rural health centers, home care, and others.[38] With a goal of supporting the complex needs of individuals, public health, and population health, New York not only needs to include behavioral health providers, rural providers, and home care in the exchange of health data and information, but also sectors such as health-related human services and housing; criminal justice; workforce, and education. Medicaid has a vision for this with the Social Care Networks and the HERO included in the recently approved 1115 waiver, but we will need to see how all of the moving parts begin to move together.
There is a broad range of data and information that could be integrated with the SHIN-NY. New York policymakers would benefit from robust discussions with peer state HIEs, as well as with stakeholders in New York who are on the ground, providing care, and trying to navigate the current siloed data and information ecosystem in the best interests of their patients and populations. We are in an era of data-driven decision making and New York is working with an anachronistic data and information infrastructure that constrains both the value we can glean and the breadth of our ability to innovate. In order to improve healthcare delivery for New York’s communities and to address the long-standing inequities in access and outcomes, we need to modernize our data and information infrastructure to produce accurate, timely, and actionable information. We can do this by developing a comprehensive health and health-related data strategy with centralized leadership and the authority to engage partner State agencies to reach across the data silos.
A tension exists within the context of evolving technology, between making changes today that may be obsolete in a few years’ time, as opposed to waiting for the next generation of technology. The researcher Andrew Kennedy characterizes this tension as a dilemma in a paper called The Wait Calculation and the Incentive Trap of Progress in the context of interstellar travel. On a more mainstream topic, Ethan Mollick has used the conundrum of the “wait calculation” in the context of the rapidly developing technology of artificial intelligence.[39] The wait calculation can similarly be used to consider the development of health information exchange. It seems that New York has waited (perhaps not fully realizing that it was waiting), and now, with the developments in federal rules and policies, information technology, use cases, and more, New York is at the stage where moving ahead is the best course of action.
Recommendations
Adopt the proposed amendments to the SHIN-NY regulations
Re-start the APD Stakeholder Meetings and make the APD governance process more transparent
Develop a broad strategic plan and roadmap to produce and make more accessible:
data and information related to the healthcare delivery system, similar to the Massachusetts CHIA
health information for the purposes of individual and population health management, and policy and payment model evaluation
public health and health-related social needs data and information, and
consumer-facing information
The broad strategic plan and roadmap for the health and health-related data and information ecosystem should look beyond the Medicaid 1115 waiver
What is the vision for the SHIN-NY and NYeC?
What is the vision for the Social Care Networks and the HERO, post-waiver?
How does the public health data modernization effort at DOH fit into the overall data and information strategy?
How does the work with data and information related to healthcare global budgeting and health equity fit into the overall strategy?
How does the HIT-Enabled Quality Measurement Roadmap fit into the overall strategy?
How do all the data and information pieces fit together?
Establish a statewide data governance structure and develop broader data sharing agreements across NYS government agencies and authorities
Begin by undertaking a review and inventory similar to Connecticut’s process[40],[41]
Once the review and inventory are complete, identify specific sharing frameworks and processes to guide the continued expansion of cross-agency data sharing
Encourage NYS entities to align with and participate in TEFCA
Develop a single, statewide healthcare entity (health systems, providers, and social services) data sharing agreement similar to California’s
Appendix A
How Other States are Managing their HIEs and Integrating Health Data and Information
Exemplary Models
As referenced above, the management of HIEs and the integration of health data and information vary across states, with each adopting distinct approaches and strategies to address governance, use and users, privacy and security, and sustainability. David Horrocks, et al. examine five model states based on their survey work among all state HIEs examining their broad connectivity, strong interoperability services, and innovative practices, to demonstrate different approaches.
Arizona emphasizes public-private partnerships to expand its HIE network – “[S]tate statute requires the Arizona Department of Health Services (ADHS) to designate a qualifying HIE organization for certain purposes, including to operate a health care directives registry.”[42] Indiana stands out for its early adoption of HIE in 2004, with roots back to 1993.
Indiana is focused on self-sustainability and a hands-off approach from the state government with no mandates or incentives for participation, yet “[T]oday, nearly all Indiana health care providers have chosen to connect to the HIE. The organization’s largely self-developed technology stack, which provides flexibility with low licensing costs, also enhances its sustainability.”[43]
Maryland has taken a centralized approach, investing in a single nonprofit HIE, CRISP, to serve the entire state with strong support from state resources, and regulation. CRISP collaborates with other state-designation HIEs to share technology infrastructure and to innovate collectively. As described by Horrocks:
“CRISP operates the prescription drug monitoring program (PDMP), serves as a reporting hub for the state’s “All-Payer Model” hospital financing system, is the mechanism for patients to access their own Medicaid records, has become the key platform for capturing and reporting COVID-related statistics, and generates real-time ED utilization data for the Maryland Institute for Emergency Medical Services Systems (MIEMSS).[44]”
Michigan encourages innovation and competition among HIEs, eventually leading to a consolidated, state-designated entity that fosters high participation rates through financial incentives. Michigan healthcare providers are “… financially incentivized by health plans to contribute data on a use case by use case basis. MiHIN [Michigan Health Information Network] calls the innovative approach the “Use Case Factory.”[45]
Nebraska uses a public-private partnership model with a Governor-appointed Health IT Advisory Board for its state-designated HIE. Nebraska uses a variety of mandates and incentives to produce a broad uptake of HIE, including required connection by managed care organizations and all payer claims submission into the HIE. Horrocks notes:
“CyncHealth [Nebraska’s primary HIE] provides the state capabilities that might typically be found in an all-payer claims database (APCD), linking these records with clinical information and social factors data. By combining data in partnership with the HIE, the state enhances the datasets available to clinicians and public health agencies. DHHS leverages CyncHealth to help it capture data from the field for purposes including reportable lab results and syndromic surveillance. And DHHS uses CyncHealth to communicate public health data back to clinicians, such as reportable conditions and EMS records.”
Appendix B
Vision, Initiatives, and Action Plan Alignment from the NYS DOH’s Health Information Technology-Enabled Quality Measurement Roadmap
Initiatives (2020 – Present)
Action Plan Alignment
Endnotes
[2] NYeC – Who We Are
[3] NYeC - What does the SHIN-NY do?
[5] The Impact of Population Health Analytics on Health Care Quality and Efficacy Among CPC+ Participants
[6] NYS DOH – All Payer Database
[7] ibid
[8] The Health Insurance Coverage of the Total Population chart identifies the following percentages of health insurance coverage for NY in 2022: Employer (private/commercial – incl. ERISA): 47.2%; Non-Group (private/commercial): 5.6%; Medicaid (incl. dual eligible): 28.5%; Medicare (excl. dual eligible): 13.5%; Military: 0.4%; Uninsured: 4.9%.
[12] The “allowed amount” is a contracted rate with a payer. The “post-adjudicated amount” is the allowed amount minus any cost sharing (co-pay, co-insurance and/or deductible).
[13] NYS Health Connector Volume and Estimated Cost of Hospital Services, states, “The amount an insurer
pays a hospital or the amount that an individual consumer would pay may be different than the costs shown on this dashboard. The goal of this dashboard is to support consumers in understanding that variation occurs, and that discussing differences in cost and volume for these procedures with a medical professional can help consumers make informed health care decisions.”
[14] FAIR Health is a nonprofit organization with a mission of establishing transparency of healthcare costs and health insurance information, that manages a database of “privately billed health insurance claims and … Medicare Parts A, B, and D claims from 2013 to the present.”
[15] Privacy and Security Policies and Procedures for Qualified Entities and their Participants in New York State under 10 N.Y.C.R.R. § 300.3(b)(1)
[17] ibid
[21] US GAO - Electronic Health Information Exchange Use Has Increased, but Is Lower for Small and Rural Providers
[22] CMS AND ONC Final Regulations Define Meaningful Use and Set Standards for Electronic Health Record Incentive Program
[25] Qualified Entity (QE) Minimum Core Services Technical Requirements, Version 1.6, Revised January 2023
[27] An interesting discussion of HIE policy strategies in five nations, and the challenges those differences present, is in Health Information Exchange: Understanding the Policy Landscape and Future of Data Interoperability.
[31] Defined in the proposed regulations as, “… any health care provider, health plan, governmental agency or other type of entity or person that has executed a statewide common participation agreement with a qualified entity or with the entity that facilitates their connection to the SHIN-NY statewide data infrastructure, pursuant to which it has agreed to participate in the SHIN-NY.”
[35] HIMSS - 21st Century Cures Act—A Summary
[44] Ibid, pg. 4
[45] Ibid, pg. 5
Comments