Del. Admin. Code tit. 1, 100, 103, att. B - Data Submission and Use Agreement Template

Data Submission and Use Agreement Between the Delaware Health Information Network and name of Reporting Entity

For the Delaware Health Care Claims Database

This Data Submission and Use Agreement between the Delaware Health Information Network ("DHIN"), a not-for-profit statutory instrumentality of the State of Delaware located at 107 Wolf Creek Blvd, Suite, 2, Dover, DE 19901 and [name of reporting entity] (the "Reporting Entity") sets forth the terms and conditions for the collection and use of health care claims data for the Delaware Health Care Claims Database.

Recitals

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,

NOW THEREFORE THE PARTIES AGREE AS FOLLOWS:

1. Precedence
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.
b. Definitions in Section 2.0 of the HCCD Regulations shall also pertain to this Agreement.
2. Data Submission: Privacy and Security
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.
b. The HIPAA Privacy Rule permits covered entities to disclose PHI for general public health activities per 45 CFR 164.512(b)(1)(i).
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.
3. Data Submission: Collection
a. Reporting 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 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.

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c. Reporting Entity shall submit data files using protocols developed by the HCCD.
i. The Submission Guide shall reflect the content and formats in use by similar databases in other states.
ii. The data submission specifications shall be updated no more than once per calendar year.
iii. The parties agree to review and discuss any such changes prior to the effective date.
iv. Reporting 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 Entity in providing data submissions that conform to specifications.
d. Reporting Entity shall provide corrected data files within the timelines established in subsection 4.4.1 of the HCCD Regulations, or as mutually agreed.
e. Upon agreement between DHIN and the Reporting Entity, the Reporting Entity may submit additional data to the HCCD to improve or augment established reporting.
f. DHIN will review the Submission Guide and any subsequent annual revisions with Reporting Entity prior to the 180 day implementation period and on an annual basis thereafter.
g. Data collection methodologies in the Submission Guide shall facilitate uniformity among various health care claims databases of other states and specification of data fields, consistent with national standards.
h. Reporting Entity may request exemptions from specific data collection requirements, including minimum standards for reporting, subject to the approval of the HCCD Administrator.
4. Claims Data Uses
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.
i. Reporting Entities shall be given opportunity for comment prior to release of Claims Data.
ii. Determinations of the Committee shall be provided in writing to the requesting party.
iii. Decisions of the Committee shall be final and not subject to appeal.
b. Data Requestors may include payers, providers and purchasers.
c. The submitted claims data may be used for the broad purposes described in the enabling statute, including:
i. Alternative delivery and payment models
ii. Population health research
iii. Provider risk-sharing arrangements
iv. Public transparency
v. Other uses in furtherance of the "Triple Aim" of improved health, health care quality and experience, and affordability
d. Detailed permitted uses include, but are not limited to, the following:
i. Population health research and reporting on disease incidence, prevalence, and geographic distribution, costs of care and service utilization
ii. Health care service price variation reports and studies
iii. Design, model and evaluate payment models and purchasing initiatives
iv. Effects of care delivery strategies (e.g., care coordination, behavioral health integration) on utilization and outcomes
v. Efficiency of care, service models or procedures based on quality, value and/or outcomes
vi. Public facing provider performance reports
vii. Augment patient-specific records with data derived from the HCCD to improve the care of the patient, ensure better outcomes and deliver better value.
e. Publicly available data and reports shall, to the fullest extent practicable, comply with guidance in Statement 6 of the United States Department of Justice and Federal Trade Commission Enforcement Policy on Provider Participation in Exchanges of Price and Cost Information, August 1996, as the same may be amended, supplemented or modified from time to time, available at https://www.justice.gov/atr/statements-antitrust-enforcement-policy-health-care#CONTNUM_49 (last visited June 5, 2017).
f. Standard public-facing reports may be developed which provide aggregated, summary level views of the data in accordance with the statutory purpose of public transparency.

Applicable Law:

This Agreement shall be governed by and construed under the laws of the State of Delaware without regard to conflicts of law principles.

IN WITNESS WHEREOF, and intending to be legally bound thereby, the Parties have caused their duly authorized representatives to execute this Agreement.

Signatories:

[Reporting Entity] Delaware Health Information Network

____________________________________ ____________________________________

[Name] Janice L. Lee, MD

[Title] Chief Executive Officer

Date: Date:

Notes

Del. Admin. Code tit. 1, 100, 103, att. B
21 DE Reg. 293 (10/1/2017)
22 DE Reg. 465 (12/1/2018) (Final)

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