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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsDecember 2017


Regulatory Flexibility Act Form

Authenticated PDF Version

This regulation supports implementation of 16 Del.C. Ch. 103, Subchapter II, The Delaware Health Care Claims Database. It summarizes the allowable purposes for access to claims data, the process by which a request for access to claims data will be reviewed and evaluated, and factors that will be considered in granting or denying such requests. It delineates the structure and duties of the Health Care Claims Database Committee.
Sub-regulatory information may be found on the DHIN web site at www.DHIN.org to include the form to be used for requesting access to claims data and the general business rules to be followed by the Health Care Claims Database Committee.
1.1 Statutory Authority. 16 Del.C. §10306 authorizes the Delaware Health Information Network (DHIN) to promulgate rules and regulations to carry out its objectives under 16 Del.C. Ch. 103, Subchapter II.
"Approved User" means any person or organization that DHIN has authorized to view or access data from the Health Care Claims Database, including Delaware state agencies and DHIN itself.
"Claims Data" includes Required Claims Data and any additional health care information that a voluntary reporting entity elects, through entry into an appropriate Data Submission and Use Agreement, to submit to the Delaware Health Care Claims Database.
"Clinical Proxy Data Elements" means any health care information contained within Claims Data which describes a rendered clinical service, including but not limited to: procedure codes, diagnosis codes, dates and locations of clinical services, healthcare providers, and pharmacy data, and excludes Pricing Information.
"Collaborating State Agencies" shall refer to the Delaware Office of Management and Budget, State Employee Benefits Committee, Division of Public Health, and Division of Medicaid and Medical Assistance and their successors, if applicable.
"Data Submission and Use Agreement" or "DSUA" shall mean the agreement between the HCCD Administrator and the Reporting Entity describing the specific terms and conditions for data submission and use.
"De-Identified Data" refers to health information as defined in the HIPAA Privacy Rule, which is not considered PHI because it excludes the following direct and indirect patient identifiers:
"HCCD Administrator" shall mean the Delaware Health Information Network and its staff and contractor(s) that are responsible for collecting data submissions, providing secure production services and providing data access for approved users.
"Health Care Claims Database" or "HCCD" shall mean the database and associated technology components maintained by DHIN and authorized under 16 Del.C. Ch. 103, Subchapter II.
"Health Care Claims Database Committee" (the "Committee") shall mean the subcommittee established by the Delaware Health Information Network Board of Directors and governed by its by-laws that has the authority to determine when applications for Claims Data should be provided to a data requestor to facilitate the purposes of the enabling legislation, and such other duties as designated by the DHIN Board of Directors consistent with the enabling legislation.
"Health care services" means as defined in 18 Del.C. §6403.
"Identified Data" refers to data that contains direct patient identifiers.
"Limited Data Set" refers to a limited set of PHI as defined in the HIPAA Privacy Rule, which excludes direct patient identifiers. A Limited Data Set excludes all of the same data elements as De-Identified Data, with the following exceptions:
"Mandatory Reporting Entity" means the following entities, except as prohibited under federal law:
The State Employee Benefits Committee and the Office of Management and Budget, under each entity's respective statutory authority to administer the State Group Health Insurance Program in 19 Del.C. Ch. 96, and any Health Insurer, Third Party Administrator, or other entity that receives or collects charges, contributions, or premiums for, or adjusts or settles health claims for, any State employee, or their spouses or dependents, participating in the State Group Health Insurance Program, except for any carrier, as defined in 29 Del.C. §5290, selected by the State Group Health Insurance Plan to offer supplemental insurance program coverage under 29 Del.C. Ch. 52C.
"Member" means individuals, employees, and dependents for which the Reporting Entity has an obligation to adjudicate, pay or disburse claims payments. The term includes covered lives. For employer-sponsored coverage, Members include certificate holders and their dependents. This definition includes all members of the State Group Health Insurance Program regardless of state of residence.
"Pricing Information" includes the pre-adjudicated price charged by a Provider to a Reporting Entity for Health Care Services, the amount paid by a Member or insured party, including co-pays and deductibles, and the post-adjudicated price paid by a Reporting Entity to a Provider for Health Care Services.
"Protected Health Information" or "PHI" refers to individually identifiable health information as defined in the HIPAA Privacy Rule.
"Provider" means a hospital, facility, or any health care practitioner licensed, certified, or authorized under State law to provide Health Care Services and includes hospitals and health care practitioners participating in group arrangements, including accountable care organizations, in which the hospital or health care practitioners agree to assume responsibility for the quality and cost of health care for a designed group of beneficiaries.
"Reporting Entity" means either a Mandatory Reporting Entity or a Voluntary Reporting Entity.
"Required Claims Data" as authorized under 16 Del.C. §10312(8) shall mean the required data containing records of member eligibility, medical services claims and pharmacy claims as specified in the Submission Guide.
"Submission Guide" shall mean the document providing the specific formats, timelines, data quality standards and other requirements for claims data submission, incorporated as Addendum One to the DSUA. It shall be established and maintained as technical guidance document and substantively updated on an annual basis.
"Voluntary Reporting Entity" includes any of the following entities that has chosen to submit or has been instructed to submit data at the request of an employer or client and enters into a Data Submission and Use Agreement, unless such entity is a Mandatory Reporting Entity:
Last Updated: December 31 1969 19:00:00.
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