Source: http://regulations.delaware.gov/register/october2017/final/21%20DE%20Reg%20293%2010-01-17.htm
Timestamp: 2018-11-19 03:20:03
Document Index: 198670780

Matched Legal Cases: ['§10306', '§10306', '§10306', '§10118', '§10314', '§10002', '§10313', '§10313', '§103', '§10314', '§10311', '§ 10314', '§10313', '§10314', '§10313', '§10312', '§10118', '§4004', '§906', '§7103', '§3802', '§10002']

Statutory Authority: 16 Delaware Code, Sections 10306 & 10311-10315 (16 Del.C. §§10306, 10311-10315)
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).
Highmark BCSD Inc. (Highmark Delaware) and UnitedHealth Group offered the following summarized observations. The Delaware Health Information Network (DHIN) has considered each comment and responds as follows.
DHIN Response
"Claims data": Clarify that this term includes the capitalized term "Claims Data" as used in the proposed regulation and "Required Claims Data" as the term is defined in Section 2.
The definition of Claims Data in Section 2.0 is revised as follows:
"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.
Health Care Claims Database Committee
"Health Care Claims Database Committee": Include within the definition of this term that the Committee shall consist of at least two Mandatory Reporting Entities, and at least one of which shall be a national payer with experience participating in databases similar to HCCD.
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.
Onboarding of new Mandatory Reporting Entities
Subsection 3.2: In order to begin the development and run up for data submission where a Mandatory Reporting Entity has not been actively reporting data due to membership levels being below the mandatory threshold level, we recommended ensuring the newly mandatory reporting for these entities be done in a mutually agreeable fashion in order to ensure that each party's expectations are aligned with respect to the work needed to begin data submissions.
As outlined in Subsection 3.2, onboarding of new Mandatory Reporting Entities will be based on a compliance schedule developed by the Health Care Claims Database Administrator and the newly Mandatory Reporting Entity.
Subsection 4.4.1: Corrected and conforming files should be due no less than 20 business days following notification from the HCCD Administrator. The current proposal of 10 business days leaves little time to investigate, build and correct data files that may require substantial reprograming.
As outlined in Subsection 4.4.1, the Health Care Claims Database Administrator may grant extensions of deadlines in circumstances when additional time is required.
Subsection 5.1; Due to the potentially sensitive nature of the information being submitted to the HCCD, which includes trade secrets and commercial or financial information, including for example plan paid and allowed amounts, we strongly recommend updating this subsection to include reference to the section of Delaware law that protects this type of commercial and financial information from being classified as a Public Record under the Freedom of Information Act.
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.
Historical Files: Required Claims Data files for calendar years 2013 and 2014 have been placed in archive and are not easily accessible and programmable for data submission to the HCCD. It would take approximately two years to retrieve such data from archive and submit to the HCCD in its required format. It would also be unduly burdensome for UnitedHealth Group to retrieve and submit it, because it is not archived in its original data format. For these reasons we strongly recommend limiting historical data submissions to the current and two previous calendar years (2015, 2016, and 2017).
To accommodate those instances when a Mandatory Reporting Entity is unable to comply with the Reporting Schedule or Submission Guide – most commonly when a payer’s system does not collect a required element or the payer would experience an unreasonable burden in providing the information – the HCCD Administrator may authorize Mandatory Reporting Entity-specific overrides and variances. This override and exception process is outlined in Section 4.3 of the Submission Guide.
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.
By entering into the Data Submission and Use Agreement (DSUA), Mandatory Reporting Entities will be agreeing to the terms and conditions described therein, thereby rendering the DSUA “mutually agreeable.”
In order to develop a mutually agreeable data submission and use agreement, we have provided a redlined copy of the DSUA with what we believe are the minimally necessary changes. These include for example:
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 3c.: A new Section 3c. has been inserted to recognize that the parties to the DSUA will work in good faith with each other to meet data submission, reporting, and timeframes, and that where a Reporting Entity is unable to meet a requirement of the DSUA or HCCD Regulation, that the parties will work in good faith to find a mutually agreeable solution.
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.
By entering into the DSUA, Mandatory Reporting Entities will be agreeing to the terms and conditions described therein, thereby rendering the DSUA “mutually agreeable.”
Each requirement for data submission, reporting, and timeframes already includes a provision for mutual agreement and resolution in cases in which the Reporting Entity is unable to comply with the stated requirement. It is unnecessary to add an additional paragraph to that effect.
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.
The DSG contains no thresholds. While a majority of fields are marked with an "R'' and it appears the expectation is that data will be provided at 100% completion, it should be noted the data does not exist at 100% completion. Additional information will be necessary to identify the actual threshold being requested as well as information on the actual variance process.
The Submission Guide has been revised to include threshold levels for all data elements and more detail on the override and exception process (Section 4.3).
In the eligibility file, there are a number of Primary Care Physician or PCP fields. UnitedHealth Group has limited PCP demographics.
The medical claim file requires a Claim Version number, Ambulatory Payment Classification, Present on Admission Indicator, Servicing Provider, Capitated Service Indicator, Provider Network Indicator data elements, which are not always available. A variance will be needed for these fields.
In the pharmacy claim file the Claim Version Number is a required field. This data element is unavailable in our claims data warehouse and will not be reportable. A variance will be needed for this field.
The provider file specifications require data for servicing provider. This data is available approximately 90% of the time. The Billing provider data is available approximately 95%. A variance will be needed.
The Submission Guide has been revised based on feedback received, and the updated version 0.3 dated September 17, 2017 has been posted to the DHIN website. If a Mandatory Reporting Entity is not able to comply with the requirements outlined in the Submission Guide, they will need to apply for an override or exception as outlined in Section 4.3 of the Submission Guide.
Highmark Feedback
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.
Attachment B. Data Submission and Use Agreement Section 1. a. . . “The HCCD Regulations shall take precedence over any terms and conditions represented in this Agreement”. In light of this wording, is it your understanding that the DSUA can include clauses that the parties have agreed to involve matters that are either not addressed in the HCCD Regulations, or are not fully determined by the Regulation?
Attachment B. Data Submission and Use Agreement Section 3. b. “or as mutually agreed” While interested in retaining this clause, in light of the next sentence in the Regulation stating that ‘in case of conﬂict between this Agreement and the HCCD Regulations, the HCCD Regulations shall take precedence”, please explain a circumstance in which the contractual and regulatory reporting schedule would not override any mutual agreement to any other dates?
Attachment B. Data Submission and Use Agreement. In the absence of proposed regulatory wording addressing situations identiﬁed in §10314(e) in which data use requests are received from potential competitors of a reporting entity, please explain how DHIN will address these instances. We recommend a meeting to discuss this statutory obligation in order to assure whether (and possibly how) it must be included in the proposed regulation. This is made more important due to the DSUA item 1 statement that the Regulation takes precedence over any terms of 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.
The Data Submission and Use Agreement template duplicates the data submission schedule outlined in Attachment A to the HCCD Data Collection Regulation. Should the regulation be amended at some future time to modify the data submission schedule, this language ensures that the schedule as specified in the regulation takes precedence over the schedule in the DSUA without requiring the Parties to renegotiate the DSUA in its entirety.
DHIN intends to promulgate a separate regulation on access to data through the HCCD. It will provide greater detail regarding the methods and process for requesting access to claims data and the situations in which such requests might be granted or denied. All statutory obligations regarding protection of and access to protected health information and sensitive business information will be addressed in the data access regulation.
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’.
In the absence of a single identifier used by all Reporting Entities to uniquely identify patients, DHIN will use technology tools and matching algorithms to link data submitted by multiple Reporting Entities on the same person. DHIN has over a decade of experience in this activity due our work with linking clinical data into a longitudinal Community Health Record. We have found that including at least the last four digits of the patient’s social security number improves the match rate very significantly. A clean match will be needed in order to link a patient’s data across all of their insurance providers (e.g. coordination of benefits) and follow a patient’s claims and enrollment historical longitudinally.
If a Mandatory Reporting Entity does have an optional data element in its records, is it obligated to report that data element? If not, what are the criteria that the submitter must satisfy in order to not report that element?
As outlined in Section 4.1 of the Submission Guide, a data element marked as “O” is optional but should be provided when available. Otherwise, the field may contain a null value.
What special security protections are contemplated by DHIN as a result of collecting Social Security numbers?
As the Health Care Claims Database Administrator, DHIN will ensure that all data is stored in a highly secure environment, following both DHIN’s HITRUST Certified Process and all CMS protocols for the secure storage of sensitive information.
Concern regarding the alignment of Highmark Delaware’s existing commitments to individuals and others regarding the sharing of data with the obligations of providing data to DHIN which will then share with others.
The Health Care Claims Database (HCCD) Administrator is committed to serving as a responsible steward of patient data and has invested heavily in its infrastructure and security safeguards to make sure that data arrives and resides securely. The HCCD Committee, appointed by the DHIN Board of Directors and comprised of multidisciplinary stakeholders, will further ensure that data is shared responsibly and only for the purposes of the enabling legislation.
In light of the fact that commercial and ﬁnancial information of a privileged and conﬁdential nature is being collected, how does DHIN commit to achieving and maintaining appropriately high security standards?
Does the proposed Regulation contemplate allowing a DSUA which
a. requires DHIN to maintain particular standards of security
b. entitles data submitters to audit or otherwise have access to reasonably assure themselves regarding the security of their data
c. may require imposing different terms in data use agreements depending upon the nature of the different potential users of an entity’s data
d. entitles a submitter to not provide optional information
The Health Care Claims Database (HCCD) Administrator is committed to serving as a responsible steward of patient data and has invested heavily in its infrastructure and security safeguards to make sure that data arrives and resides securely. DHIN is certified under the HITRUST security framework as following industry best practices in protecting the privacy and security of protected data. The HCCD Committee, appointed by the DHIN Board of Directors and comprised of multidisciplinary stakeholders, will further ensure that data is shared responsibly and only for the purposes of the enabling legislation. DHIN will negotiate the terms of the Data Submission and Use Agreement with Reporting Entities to arrive at mutually agreeable terms that do not undermine either the letter or spirit of the enabling statute and supporting regulations.
The public was given notice of DHIN's intention to adopt the proposed regulation and was given opportunity to provide DHIN with comments. The required Regulatory Flexibility Analysis and Impact Statement for this proposed regulation was submitted. Public comments were received, considered, and response provided. Thus, the Delaware Health Information Network (DHIN) finds that the proposed regulation should be adopted as in the best interest of the general public of the State of Delaware.
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).
Janice L. Lee, MD, Delaware Health Information Network
"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.
"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.
"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.
"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:
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.
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.
21 DE Reg. 293 (10/01/17) (Final)