This regulation codifies certain requirements that have already been incorporated into grant contracts between the Department and grantees under Phases 1, 5, 10, 17 and 22 of the Health Care Efficiency and Affordability Law for New Yorkers (HEAL NY) Capital Grant Program. Under HEAL NY, the Department has provided over $400 million for health information technology (“health IT”) projects. Grantees include: a Not-for-Profit corporation called New York eHealth Collaborative, Inc. (“NYeC”), which is currently New York’s State-designated entity to promote health IT; and a number of Regional Health Information Organizations (RHIOs), which facilitate interoperability among the disparate electronic health record systems that contain patient information.

Under this regulation, certain policies that have already been incorporated into the HEAL NY grant contracts will continue to be updated under a statewide collaboration process that results in SHIN-NY Policy Standards. An organization such as NYeC will be the State designated entity. Existing RHIOs and other such health information exchange organizations may apply to become qualified health IT entities (QEs). To become a QE and to maintain that designation, an organization must adhere to policies, such as the SHIN-NY Policy Standards, that enable widespread interoperability among disparate health information systems, including electronic health records, personal health records and public health information systems, while protecting privacy and security.

This regulation makes clear that, consistent with 42 USC § 17938, QEs may make it possible, without patient authorization, to make patient information available among disparate health care providers so long as the QEs enter into and adhere to participation agreements with their participants that comply with federal requirements under HIPAA and 42 CFR Part 2 for business associates and qualified service organizations. This regulation creates a general rule that a written authorization is required to access patient information made available through the QEs. When an emergency condition exists, however, and a health care provider is authorized to provide treatment without the consent of the patient, the health care providers may also “break the glass” and access information as needed to provide such treatment. This regulation incorporates legal requirements related to disclosure of patient information without consent, as well as laws that specifically authorize disclosure of patient information for health care purposes, including public health and health oversight purposes, without the type of written, signed authorization that contains all of the elements that would be required for a health care provider to get permission to disclose patient information to a third party for purposes other than health care.

This regulation establishes the structure for the SHIN-NY after the HEAL NY program winds down and the State loses the ability to enforce requirements solely through grant contracts. The Department will continue to partner with a state designated entity, whose functions are set out. In order to participate in the SHIN-NY, health information exchange organizations will need to be certified under a QE certification process and satisfy certification requirements on an ongoing basis under the procedures established by this regulation.

Statutory Authority:

Public Health Law Section 206(18-a)(d) authorizes the Commissioner of Health to make rules and regulations to promote the development of a self-sufficient Statewide Health Information Network for NY (SHIN-NY) to enable widespread, non-duplicative interoperability among disparate health information systems, including electronic health records (EHRs), personal health records (PHRs) and public health information systems while protecting privacy and security. Part G of Chapter 57 of the Laws of 2006 established the “office of Health e-Links” to implement health information technology across the state.

Purpose of Regulation:

This regulation will formalize and update the current governance structure and process for operation of the SHIN-NY in order to advance health information technology adoption and use on a statewide basis for the public good.

• The Department of Health (DOH) would enter into a contract to establish a state-designated entity (SDE) that manages development and operation of the SHIN-NY.

• DOH and the SDE, utilizing the statewide collaboration process, would develop and adopt policies to regulate health information exchange using the SHIN-NY.

• The policies would be implemented by Qualified health IT Entities (QEs) (including RHIOs) through participation agreements with providers and patient consent. The policies also comply with federal and State laws, including the very strict laws regarding the confidentiality of alcohol and drug abuse treatment records under 42 CFR Part 2, confidential HIV-related information under PHL Article 27-F and mental health records under Mental Hygiene Law Article 33.

• The regulations would allow for the exchange of health information about minors of any age in a way that complies with current state and federal laws and regulations related to minor consented services.

• DOH would create a certification process for QEs/RHIOs that ensures standard criteria are met for providing services to its members and that the number of QEs is sufficient to provide access to health information exchange services statewide.

• A financial commitment is necessary to ensure the development and operation of the SHIN-NY. As part of the State’s 2014/15 budget, the SHIN-NY was appropriated $55 million via the Covered Lives Assessment. Additionally, via an Implementation Advance Planning Document Update (IAPD-U) approved from the Centers for Medicare and Medicaid Services (CMS), matching funding for ongoing and planned health information exchange (HIE) projects and Federal Financial Participation (FFP) will provide approximately $31 million to be utilized to support the achievement of the goals and objectives established for the SHIN-NY. A sustainability plan for the continued development and operation of the SHIN-NY shall be developed and submitted to the Department for its approval.

Benefits of Regulation:

The regulation is intended to support the triple aim of improving the patient care experience (including quality and cost), improving the health of populations, and reducing the per capita cost of health care through the broad adoption of health information exchange by:

• increasing patient record availability on a statewide basis;

• establishing the core set of health information exchange (HIE) services that provide clinical and administrative value to the healthcare system and are available to all providers and all patients in New York State;

• reducing barriers for EHR integration with HIE services;

• establishing a mechanism for state and local public health and health oversight activities through a more streamlined and timely process;

• expanding the use of EHRs, which should improve health care for underserved populations in the state, including rural areas.

Through its agreement with DOH, the state designated entity is responsible for implementing the key components of the state strategy and business plan specified by the Department which includes:

• increasing adoption of the SHIN-NY by hospitals, physician practices, clinics and long-term care facilities with patient consent for sharing personal health information in a secure, protected manner;

• increasing utilization of the SHIN-NY for public health and health oversight activities including disaster preparedness and response;

• engaging health plans to connect to the SHIN-NY; and

• managing operating costs.

State and Local Cost:

To date, the development of the SHIN-NY and expansion of EHR adoption has been funded through a combination of federal and state funds distributed through grant programs, as well as private contributions from participating health plans, providers and other stakeholders. Currently, over 170 hospitals and over 8200 primary care providers qualify for “meaningful use” incentives under Medicaid and Medicare. In addition, through HEAL NY funding, it is expected that over 7800 primary and specialty care providers were supported to have adopted EHRs and be connected to the SHIN-NY by the end of 2013. Over 70% of hospitals in New York State participate in RHIOs, and over 50% of Federally Qualified Health Centers (FQHCs). In order to ensure that New York continues to reap the value of its health IT investments, it is critical to identify ongoing and sustainable funding for its key HIE infrastructure – the SHIN-NY.

Investment in the operation of the SHIN-NY will also generate a substantial return through the elimination of wasted expenditures and promoting better quality health care at a lower cost. Three studies conducted in Rochester by the Health Information Technology Evaluation Collaborative (HITEC), an academic research consortium with contracts with the State Department of Health to perform evaluation activities for the HEAL NY Program identified improved quality and reduction in duplicative testing and in readmission rates for a two year study period for events in 2009-2010. Use of the Rochester RHIO by five Emergency Departments (EDs) resulted in 6 averted admissions per 100 patients who came to the ED, resulting in $9 million projected savings annually across the adult community. Extrapolating the cost savings across the state would result in an annual savings of $52 million. During the same study period, image exchange use through the Rochester RHIO within 90 days following an initial imaging procedure reduced the probability of repeat imaging by 35%. Finally, use of the Rochester RHIO after hospital discharge resulted in a 55% reduction in readmission within 30 days. These highly significant findings with important financial implications further demonstrate the value of the SHIN-NY.

An 18-month study in the Buffalo region looked at the number of multiple CT scans ordered for the same body part, for the same patient, over a six-month period. During the period 2,763 CT scans were deemed to be potentially unnecessary, duplicative tests. 90% of the potentially duplicative tests were ordered by physicians who never or infrequently access the local health information exchange. By local calculations, that amounts to a potential additional cost of $1.3 million over a six-month period for one test in one region of the state.

It is estimated that operating support for the State’s Health Information Exchange Network will require an annual commitment of approximately $70 million for technical operations, development, member services and statewide policy work.

Costs to Regulated Entities:

The proposed regulation will require that health care facilities defined in PHL Section 18, and practitioners in the private practice of medicine that utilize certified EHRs, connect to the SHIN-NY. In New York State there are 228 general hospitals, 1198 hospital extension clinics, 1239 diagnostic and treatment centers, and 635 nursing homes. There are also 139 certified home health agencies (CHHAs), 97 long term home health care programs (LTHHCP), 19 hospices and 1164 licensed home care services agencies (LHCSAs).

Average interface costs for hospitals are $75,000 while interface costs for physician practices vary but generally average $5000 – 10,000 per practice. Interface costs for other types of facilities, such as nursing homes, home care agencies and hospice would fall in between physician practices and hospitals, depending on the size and complexity. Some RHIOs have established this functionality for their participants, and therefore, there are reduced associated interface costs for their participants, which include physician practices. In other areas, health plans have absorbed the interface costs for their network providers because they see the value of having their physicians connected to the SHIN-NY. Only health care providers, regulated by the Department of Health, using certified EHR technology need to comply with these requirements. Currently, adoption of certified EHR technology for health care facilities outside of hospitals and FQHCs is low because they are not eligible to receive meaningful use incentive payments.

The regulation is being put forth as a “public good” model, that is, a certain set of baseline services, both technical and administrative, will be made available to all providers within New York State, at no charge. The basic technical services will include; patient record look-up, secure messaging, consent management, notifications and alerts, identity management and security, provider and public health clinical viewer, public health integration and results delivery.

Local Government Mandates:

The State Enterprise Health Information Exchange as part of the SHIN-NY is designed to streamline how providers interact with the many public health information systems that currently exist, to decrease reporting burdens, promote bidirectional information exchange, and advance public health priorities. Article 28 facilities operated by local governments will be required to comply with these regulations in the same manner as other Article 28 facilities. Should local health departments need to make expenditures to comply with the regulatory requirements, they have opportunities to request funding through Article 6 Local Assistance Grant Program, and possibly other sources.

Paperwork:

Entities that wish to become QEs will need to submit an application for review by DOH to determine if the criteria outlined in the regulation have been met as well as meeting other criteria as may be required under the QE certification process. Any entity seeking certification as a QE, regardless the entity’s organizational structure, origin or type, will be subject to the full certification process. This certification process incorporates criteria that fall into four broad categories including; Organizational Characteristics, Operational Requirements, Policies and Procedures and Technical Requirements. QEs would be subject to either biennial or triennial recertification, depending on their level of scoring and would also be subject to ongoing monitoring and enforcement activities between full certifications. This all being done to ensure that patient information is made available to all providers participating in a patient’s care in a secure and confidential manner.

Duplication:

This regulation will not conflict with any state or federal rules.

Alternatives:

Because state funding for health IT infrastructure was provided through the HEAL NY program, the State Department of Health believed the best way to facilitate a standardized process for this purpose was through a formal public private partnership. Our private partner, through a contract with DOH, facilitated the statewide collaboration process of a governance and policy framework to allow health information sharing among disparate providers to improve quality, improve efficiency and reduce costs of health care on a statewide basis while ensuring the privacy and security of patient information.

Governor David A. Paterson designated the New York eHealth Collaborative as the state designated entity, and as such was able to receive federal funding for health information exchange activities. Based upon the state and federal funding, and the development of statewide policies through a statewide collaboration process, the logical next step was to develop regulations based on this framework. Since health IT is quickly evolving and the marketplace is rapidly changing with regard to new tools and services available, the implementation of regulations before now would have required amendments based on current knowledge.

While other states have different models for health information exchange, and NY considered the approaches and models used in other states through its statewide collaborative process, based on the size, complexity and diversity of New York and the resources that were available, the State Department of Health determined that the current model was the best approach. The State Department of Health shall convene and consider the recommendations of the workgroup established by Public Health Law § 206(18-a)(b), and if the State Department of Health acts in a manner inconsistent with the recommendations of the workgroup, it shall provide the reasons therefor.

Federal Standards:

This rule aligns with current federal laws and regulations governing the adoption of interoperable exchange of health information and meaningful use requirements under the HITECH provisions of ARRA. State laws regarding the disclosure of personal health information to health care providers are more stringent than the federal standards for HIPAA.

Compliance Schedule:

Since RHIOs or QEs are largely operational in NYS and the majority of hospitals and federally qualified health centers are already participants, and the number of physicians practices participating continues to grow and the infrastructure for the SHIN-NY is already in development, the estimated time period needed for regulated persons or entities to achieve compliance with the rule has been staggered. One year from the time the rule becomes effective the RHIOs/Qes need to be fully compliant with the certification requirements and provide the basic technical and administrative services defined. Two years from the time the rule becomes effective health care facilities, utilizing certified health record technology must connect to the SHIN-NY through a QE and allow private and secure bi-directional access to patient information by other QE Participants authorized by law to access such patient information.

The proposed rule will not have a substantial adverse impact on small businesses or local governments. Small businesses such as physician practices, that are not regulated by the Department, that adopt certified electronic record technology in order to qualify for meaningful use incentives, would not be required to exchange patient health information among disparate providers to facilitate care coordination and appropriate follow up. Although this exchange is encouraged, it is strictly optional for the group of practitioners. However, connection to the SHIN-NY will in fact facilitate these providers achievement of meaningful use requirements and eligibility to receive either Medicaid or Medicare Meaningful Use incentive payments. For local government agencies that report information to the state, the use of the SHIN-NY would be beneficial from an efficiency and cost perspective. Additionally, accessing the SHIN-NY to perform required local health department surveillance and case investigation activities has actually been documented to result in increased efficiency and decreased costs for the local health department.

Cure Period:

Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other opportunity for ameliorative action to prevent the imposition of penalties on the party or parties subject to enforcement when developing a regulation or explain in the Regulatory Flexibility Analysis why one was not included. This regulation creates no new penalty or sanction. Hence, a cure period is not required.

The proposed rule will not have a direct adverse impact on rural areas. Operation of the SHIN-NY and expanded use of certified EHR technology should improve health care, increase efficiency, reduce duplicative testing and reduce overall costs for underserved populations in the state, including rural areas.

The proposed rule should not have any adverse impact on jobs and employment opportunities, but in fact have the reverse effect. The development and operation of the SHIN-NY will most likely result in opportunities for the development of new applications of health IT tools and services, such as the Accelerator Program launched by the New York eHealth Collaborative to support Medicaid Health Homes, and may result in new health IT jobs in New York State. It has been estimated that the SHIN-NY, and related initiatives that use the data from the SHIN-NY has the potential to create 1,500 health technology jobs across New York State over the next five years.