(a) Requirements for submission of required claims data by a mandatory reporting entity.
(1) A mandatory reporting entity shall submit required claims data to the Delaware Health Care Claims Database by the reporting date.
(2) DHIN is subject to the provisions of this subchapter and regulations promulgated under this subchapter, and shall collect the required claims data from mandatory reporting entities by the reporting date.
(3) DHIN shall, under § 10306 of this title, promulgate a template form for a data submission and use agreement for a mandatory reporting entity to use to submit required claims data.
(4) DHIN and each mandatory reporting entity must execute a mutually acceptable data submission and use agreement. The agreement must include procedures for submission, collection, aggregation, and distribution of claims data and must provide for, at a minimum, all of the following:
a. The protection of patient privacy and data security under this chapter and state and federal privacy laws, including all of the following:
1. The Health Insurance Portability and Accountability Act (P.L. 104-191).
2. Titles XIX and XXI of the Social Security Act (42 U.S.C. §§ 1396 et seq. and 1397aa et seq.).
3. The Health Information Technology for Economic and Clinical Health (HITECH) Act (42 U.S.C. §§ 300jj et seq. and 17901 et seq.).
4. All other applicable state and federal laws relating to the privacy and security of protected health information.
b. The identification of claims data that the mandatory reporting entity elects to submit to the Delaware Health Care Claims Database in addition to the required claims data.
c. A detailed summary of how claims data that the mandatory reporting entity submits may be used for geographic, demographic, economic, and peer group comparisons.
d. A representation and warranty that DHIN shall, to the fullest extent possible, abide by nationally recognized data collection standards and methods, including the standards promulgated by the APCD Council or successor organization, to establish and maintain the database in a cost-effective manner and facilitate uniformity among various health-care claims databases of other states and specification of data fields included in submitted claims. DHIN may allow for an exemption when a submitting entity does not collect the specified data or pay on a per-claim basis.
(5) Exclusions from required claims data reporting requirement. The required claims data reporting requirements under this subchapter, and rules and regulations promulgated under this chapter, do not apply to required claims data created for an employee welfare benefit plan or other employee health plan that is regulated by the Employee Retirement Income Security Act of 1974 (ERISA), 88 Stat. 829, as amended, 29 U.S.C. § 1001 et seq., unless otherwise permitted by federal law or regulation.
(b) Submission of claims data by a voluntary reporting entity.
(1) DHIN shall collect claims data from a voluntary reporting entity under the terms and conditions of the applicable data submission and use agreement.
(2) DHIN may promulgate regulations to clarify the types of claims data that a voluntary reporting entity may submit.
(3) DHIN and a voluntary reporting entity that elects to submit claims data to the Delaware Health Care Claims Database shall execute a mutually acceptable data submission and use agreement. DHIN shall publish a template form data submission and use agreement that includes the required data submission and use agreement provisions under paragraph (a)(4) of this section.
(c) Unless modified or supplemented by regulations promulgated under this chapter, if more than 1 entity is involved in the administration of a policy, the health insurer is responsible for submitting the claims data on policies that it has written, and the third-party administrator is responsible for submitting claims data on self-insured plans that it administers.