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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsOctober 2017

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In accordance with 16 Del.C. §10306, and for the reasons set forth herein, the Delaware Health Information Network (DHIN) enters this Order adopting the Delaware Health Care Claims Database Data Collection Regulation.
Pursuant to its authority under 16 Del.C. §10306, DHIN proposes to adopt a regulation to establish procedures for submission of claims data by a mandatory reporting entity and a template for a data submission and use agreement to be entered into between DHIN and each reporting entity. The agreement includes procedures for submission, collection, aggregation, and distribution of claims data, and a summary of how claims data may be used for geographic, economic, and peer group comparisons.
DHIN gave notice of its intent to adopt the proposed regulation in the July 1, 2017 issue of the Delaware Register of Regulations. DHIN solicited written comments from the public for thirty (30) days as mandated by 29 Del.C. §10118(a).
"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.
As defined in 16 Del.C. §10314(a)(1), the Health Care Claims Database Committee shall be established by the DHIN Board of Directors. While this Regulation cannot usurp the authority of the Board to appoint this Committee, the Board has historically established subcommittees that include multidisciplinary stakeholders representing diverse voices and interests. Details on how the Committee will function will be included in a separate Regulation pertaining to Data Access.
Additional language is inserted in into Subsection 5.1 which specifically references 29 Del.C. §10002(I)(2) and confirms that trades secrets and commercial or financial information of a privileged or confidential nature is not a Public Record under the Freedom of Information Act.
Subsection 4.1: In accordance with the HCCD's enabling statute, 16 Del.C. §10313(a)(4) which requires that DHIN and each mandatory reporting entity execute a mutually acceptable data submission and use agreement, we recommend mirroring the statutory language in order to ensure the intent of the legislature that such agreements be mutually acceptable.
As stipulated in 16 Del.C. §10313(3), the DHIN shall promulgate a template form for a data submission and use agreement (DSUA) for the submission of required claims data by a Mandatory Reporting Entity. Attachment B of this Regulation serves as this template. In having a public comment period, DHIN has solicited feedback from Mandatory Reporting Entities and the general public regarding the content of this DSUA. DHIN will negotiate with Reporting Entities in good faith to reach mutually agreeable terms that generally conform to the template and meet the statutory intent. Terms that do not meet the overall requirements of the statute and regulation will not be mutually agreeable.
Section 3b.: Because the DSUA is required under 16 Del.C. §103l3(a)(4) to be mutually agreeable, where rights of the parties as mutually agreed upon between DHJN and the Mandatory Reporting Entity are greater in the DSUA than in the regulation, the terms of the DSUA should prevail since such terms have been agreed upon between the two parties. To allow DHIN to override a mutually agreeable DSUA through regulation would be contrary to the intent of the HCCD's enabling statute.
Section 4a.: This section has been revised to reflect the intent of the enabling statute that specifically restricts the purposes for which a requesting party shall be permitted to use Claims Data, which includes "facilitating the design and evaluation of alternative delivery and payment models, including population health research and provider risk-sharing arrangements." See 16 Del.C. §10314(a). While the legislative purpose and intent of the HCCD, as articulated in 16 Del. C. §10311, includes "to achieve the Triple Aim" and to "improve the public health through increased transparency" these broad themes are limited to the specific purposes articulated in§ 10314 when it comes to the use and disclosure of Claims Data to a requesting party.
The legislative intent “to achieve the Triple Aim” and “improve the public health through increased transparency” is included in the opening sections of 16 Del.C. Chapter 103 Subsection II which describe the overall purpose for the creation of the Health Care Claims Database. The fact that later sections do not specifically reference each element of the statutory purpose for enacting the HCCD should not be interpreted to restrict those purposes. The HCCD Committee members will represent the stakeholder groups and will ensure that data is only made available in conformance with the statutory purposes of the HCCD.
Please explain how the proposed Regulation and the Data Submission and Use Agreement Template are consistent with 16 Del.C. §10313 which requires ‘a mutually acceptable data submission and use agreement’? By way of example, please consider the following additional questions regarding the DSUA.
As stipulated in 16 Del.C. §10313(3), the DHIN shall promulgate a template form for a data submission and use agreement (DSUA) for the submission of required claims data by a Mandatory Reporting Entity. Attachment B of this Regulation serves as this template. In having a public comment period, DHIN has solicited feedback from Mandatory Reporting Entities and the general public regarding the content of this DSUA. DHIN will negotiate with Reporting Entities in good faith to reach mutually agreeable terms that generally conform to the template and meet the statutory intent. The intent of this language is to ensure that the terms and intent of the statute and regulation cannot be circumvented or overridden through individual agreements or contract language.
Please explain why Social Security numbers are to be provided pursuant to the Data Submission Guide when the authorizing statute (16 Del.C. §10312 (8) a.) identifies only ‘Basic demographic information, including the patient’s gender, age and geographic area of residency.’ as ‘Required claims data’.
THEREFORE, IT IS SO ORDERED, this 15th day of September, 2017, that the proposed Delaware Health Care Claims Database Data Collection Regulation 103 is adopted and shall become effective ten (10) days following publication in the Delaware Register of Regulations, in accordance with 29 Del.C. §10118(e) and (g).
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 Data]" includes [required claims data 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.
"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.
"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.
"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.
"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.
"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.
"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.
"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:
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. Reporting [Entities Entity] shall submit Required Claims Data to the HCCD according to the specifications set forth in the Submission Guide. The Submission Guide is a technical guidance document, and may be updated and replaced without replacing the entire agreement.
b. Reporting [Entities Entity] shall submit Required Claims Data to the HCCD according to the schedule set forth in Attachment A, Reporting Schedule, of the HCCD Regulations, or as mutually agreed. The schedule is included herein for convenience, but in case of conflict between this Agreement and the HCCD Regulations, the HCCD Regulations shall take precedence.
c. Reporting [entities Entity] shall submit data files using protocols developed by the HCCD.
iv. Reporting [Entities Entity] shall provide conforming data no later than 180 calendar days after publication of changes or by agreement between the HCCD Administrator and the Reporting Entity.
v. The HCCD Administrator may provide clarifications and technical corrections as needed to assist Reporting [Entities Entity] in providing data submissions that conform to specifications.
d. Reporting [entities Entity] shall provide corrected data files within the timelines established in subsection 4.4.1 of the HCCD Regulations, or as mutually agreed.
f. DHIN will review the Submission Guide and any subsequent annual revisions with Reporting [Entities Entity] prior to the 180 day implementation period and on an annual basis thereafter.
h. Reporting [Entities Entity] may request exemptions from specific data collection requirements, including minimum standards for reporting, subject to the approval of the HCCD Administrator.
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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