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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsOctober 2018

Regulatory Flexibility Act Form

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1 DE Admin. Code 103
This regulation is promulgated under 16 Del.C. §10306 and supports implementation of 16 Del.C. Ch. 103, Subchapter II, The Delaware Health Care Claims Database. It summarizes the requirements for submission of claims data by a mandatory reporting entity, to include a reporting schedule and a template for a data submission and use agreement to be entered into between DHIN and each reporting entity.
The 149th General Assembly enacted SB 227 and the Governor signed it into law on August 29, 2018. This statute expands the definition of "Mandatory Reporting Entity" in 16 Del.C. §10312. Proposed amendments to the "Definitions" section of the Health Care Claims Database Data Collection Regulation remove language which merely quotes definitions established in the code and replaces it with a statement that the terms have the meaning assigned in the code. These changes will ensure that the regulation is always congruent with the governing statute.
1.1 Statutory Authority. 16 Del.C. §10306 authorizes DHIN to promulgate rules and regulations to carry out its objectives under 16 Del.C. Ch. 103, Subchapter II.
1.2 The Health Care Claims Database ("HCCD") was created by statute, pursuant to 16 Del.C. Ch. 103, Subchapter II, under the purview of DHIN, to achieve the "Triple Aim" of the State's ongoing health care innovation efforts: (1) improved health; (2) health care quality and experience; and (3) affordability for all Delawareans. The HCCD is created and maintained by the Delaware Health Information Network (DHIN), to facilitate data driven, evidence-based improvements in access, quality, and cost of healthcare and to promote and improve the public health through increased transparency of accurate Claims Data and information. To accomplish those objectives, a centralized Health Care Claims Database was established to enable the State to more effectively understand utilization across the continuum of health care in Delaware and achieve the Triple Aim.
"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 means as defined in 16 Del.C. §10312.
"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. A template for the DSUA is Attachment B to this regulation.
"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" or 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 claims data should be provided to a Data Requester to facilitate the purposes of the enabling legislation, and such other duties as designated the DHIN Board of Directors consistent with the enabling legislation.
"Health care services" means as defined in 18 Del.C. §6403 means as defined in 16 Del.C. §10312.
"Health insurer" shall mean as defined in 18 Del.C. §4004(b). "Health insurer" does not include providers of casualty insurance, as defined in 18 Del.C. §906; providers of group long-term care insurance or long-term care insurance, as defined in 18 Del.C. §7103; or providers of a dental plan or dental plan organization, as defined in 18 Del.C. §3802 means as defined in 16 Del.C. §10312.
Mandatory Reporting Entitymeans the following entities, except as prohibited under federal law: means as defined in 16 Del.C. §10312.
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.
"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 means as defined in 16 Del.C. §10312.
"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 means as defined in 16 Del.C. §10312.
"Reporting Date" means a calendar deadline for test, historical and periodic update file submission to be scheduled on a regularly recurring basis, by which Required Claims Data must be submitted by a Reporting Entity to the Health Care Claims Database, as shown in the Data Submission Guide means as defined in 16 Del.C. §10312.
"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.
"Third Party Administrator" means as defined in 18 Del.C. §102.
"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: means as defined in 16 Del.C. §10312.
Any Health Insurer.
3.3 Excluded Mandatory Reporting Entities: As defined in 16 Del.C. §10312(3), the following providers of coverage are excluded from this rule: casualty insurance, long term care, dental care vision care, and employee welfare benefit plans regulated by ERISA.
5.1 Pursuant to 29 Del.C. §10002(I)(1) and (2), medical and other health care data on individual persons and trade secrets and commercial or financial information obtained from a person which is of a privileged or confidential nature is not a Public Record under the Freedom of Information Act.
WHEREAS Under 16 Del.C. Ch. 103 as enacted, the Delaware General Assembly directed the Delaware Health Information Network to develop, maintain and administer the Delaware Health Care Claims Database (HCCD); and
WHEREAS Effective health care data analysis and reporting are essential to achieving the Triple Aim and helping move the state's health care system from a fee-for-service to a valued-based system that rewards providers for quality and efficiency of care; and
WHEREAS Claims data are an important component of population health research and analysis and support value-based health care purchasing and prevalence of illness or injury; and
WHEREAS provider and other health care entities accepting financial risk for managing the health care needs of a population should have access to claims data as necessary to effectively manage that risk; and
WHEREAS DHIN Is authorized to create the HCCD to facilitate data-driven, evidence-based improvements in health care and improve public health through increased transparency of accurate health care claims data and information; and
WHEREAS 16 Del.C. §10313 directs that DHIN and each reporting entity shall execute a data submission and use agreement that includes procedures for submission, collection, aggregation and distribution of claims data,
a. DHIN shall promulgate regulations to implement the provisions of 16 Del.C. Ch. 103, hereinafter, and as the same may be amended from time to time, the "HCCD Regulations". The HCCD Regulations shall take precedence over any terms and conditions represented in this Agreement.
a. 16 Del.C. Ch. 103 establishes DHIN as a public health authority that is responsible for public health matters pursuant to 45 CFR 164.501.
c. Notwithstanding these provisions, DHIN shall ensure protection of patient privacy under provisions of 16 Del.C. Ch. 103, and including HIPAA, Title XIX and XXI of the Social Security Act and the HITECH Act and all other applicable state and federal privacy laws.
a. Pursuant to 16 Del.C. §10314(a)(1), Claims Data shall only be provided to a requesting party when a majority of the HCCD Committee determines that such request facilitates the statutory purposes of the HCCD.
IN WITNESS WHEREOF, and intending to be legally bound thereby, the Parties have caused their duly authorized representatives to execute this Agreement.
Last Updated: December 31 1969 19:00:00.
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