This regulation makes clear that, consistent with 42 USC § 17938, Qualified entities (QEs) may, without patient authorization, make patient information available among SHIN-NY participants or other entities otherwise serving the patient so long as the QEs enter into and adhere to participation agreements that comply with federal requirements under HIPAA and 42 CFR Part 2 for business associates and qualified service organizations. This regulation specifies consent requirements to access patient information made available through the QEs. 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.

In order to participate in the SHIN-NY, regional health information organizations will need to be certified as QEs by the Department 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 patient privacy and ensuring data security. The Department of Health is exercising this authority in conjunction with its authority under Public Health Law Articles 28, 36, 40, 44 and 47 to regulate health care facilities as defined in Public Health Law section 18.

Purpose of Regulation:

This regulation will establish requirements for qualified entities and qualified entity participants in the SHIN-NY to allow them to securely exchange information across the state.

• Qualified Entities (QEs) (including RHIOs), through participation agreements with providers and patient consent, would implement a minimum set of core services. The QEs must also comply with federal and State laws, including 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.

• The department 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.

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 to health care providers across the state;

• 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; and

• reducing barriers for EHR integration with HIE services.

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 80% of hospitals and over 75% of Federally Qualified Health Centers (FQHCs) in New York State participate in RHIOs.

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 under contract 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.

Costs to Regulated Entities:

The proposed regulation will require that health care facilities connect to the SHIN-NY.

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 some regions of the State, 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.

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. Health care facilities operated by local governments will be required to comply with these regulations in the same manner as other health care 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. Additionally, local agencies could seek a waiver to connect to their RHIO if funding is not available.

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.

Duplication:

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

Alternatives:

The Department established a statewide collaboration process to establish 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 patient privacy and ensuring data security of patient information.

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 this model was the best approach to allow for statewide health information exchange.

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, as well as federal standards regarding the exchange of certain alcohol and drug abuse patient records under 42 CFR Part 2.

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 is practicable.

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 these practitioners in private practice.

Local health departments that operate health facilities including Article 28 facilities, including outpatient departments of hospitals, diagnostic and treatment centers, free-standing ambulatory surgery centers and nursing homes, as well as home care services agencies, hospices and health maintenance organizations would be required to connect to the SHIN-NY would be impacted by the regulation if those facilities use certified electronic health record technology. 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. Costs of connecting the SHIN-NY could be offset by funds from the meaningful use incentive program. A connection to the SHIN-NY satisfies one requirement of the meaningful use incentive program and will allow providers at these facilities to access Medicaid or Medicare Meaningful Use incentive payments. The meaningful use incentive program allows all individual eligible professionals who meet meaningful use requirements to apply for incentive payments of up $43,720 over a five year period. The Department of Health, with the New York eHealth Collaborative, has implemented an additional incentive program, with support from the Centers for Medicare and Medicaid Services (CMS), to allow meaningful use providers to receive an additional incentive payment of up to $30,000 to help defray the cost of connecting to the SHIN-NY. It is anticipated that the incentive program will continue with additional funding from CMS. Additionally, any facility that is required to connect to the SHIN-NY under this regulation may request that this requirement be waived for its facilities based on economic or technical constraints.

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. Through the statewide collaboration process, local governments have the opportunity to participate in SHIN-NY policy development including providing input on draft regulations. The SHIN-NY policy committee includes representatives from the local public health agencies.

Ensuring that clinical data are available in safe, secure way supports the goals of increasing the quality of care, increasing population health and reducing healthcare costs. Hospitals that connect to the SHIN-NY have been show to decrease the number of tests and imaging studies thus reducing costs.

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 may increase the number of health IT jobs available in the state. 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 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.