Section 1.
Authority
This Rule is issued pursuant to Act 1233 of 2015 of the Arkansas
90 General Assembly, also known as the "Arkansas Healthcare Transparency
Initiative Act of 2015" (hereafter "Healthcare Transparency Initiative Act" or
"Act"). Pursuant to Act 1233 of 2015, which became effective upon signature by
the Governor of the State of Arkansas on April 8, 2015, the Arkansas Insurance
Department ("AID") is authorized to issue Rules to implement provisions of the
Healthcare Transparency Initiative Act. In addition, this Rule is issued
pursuant to Ark. Code Ann. §
23-61-108(b)(1)
which states that the Arkansas Insurance Commissioner ("Commissioner") has
authority to promulgate rules and regulations necessary for the effective
regulation of the business of insurance.
Section 2.
Purpose
The purpose of the this Rule is to establish the guidelines for
submission of medical, dental, and pharmaceutical claims, unique identifiers
and geographic and demographic information for covered individuals, and
provider files to the Arkansas Healthcare Transparency Initiative for the
purpose of creating and maintaining a multi-payer claims database as a source
of healthcare information to support consumers, researchers, and policy makers
in healthcare decisions within the state. The Rule is intended to create and
maintain an informative source of healthcare information to support consumers,
researchers and policymakers in healthcare decisions within the state and
empower Arkansans to drive, deliver, and seek out value in the healthcare
system.
Section 3.
Applicability & Scope
This Rule applies to all submitting entities as defined in
Section 4 of this Rule unless otherwise exempted pursuant to Section 5.C of
this Rule.
Section 4.
Definitions
The following definitions shall apply in this Rule:
(1) "Administrator" means the Arkansas Center
for Health Improvement;
(2) "AID"
means the Arkansas Insurance Department;
(3) "All-payer claims database" or "APCD"
means the database created and maintained by the Arkansas Healthcare
Transparency Initiative, including the ongoing all-payer claims database
project funded through the Arkansas Insurance Department, that receives and
stores data from submitting entities;
(4) "APCD Council" means a federation of
government, private, non-profit, and academic organizations focused on
improving the development and deployment of state-based APCDs;
(5) "Arkansas Healthcare Transparency
Initiative" or "Initiative" means the initiative established pursuant to Act
1233 of 2015 to create and maintain a database, including the ongoing all-payer
claims database project funded through the Arkansas Insurance Department, that
receives and stores data from submitting entities;
(6) "Arkansas Healthcare Transparency
Initiative Board" or "Initiative Board" means the advisory board established
under Act 1233 of 2015;
(7)
"Arkansas resident" means an individual for whom a submitting entity has
identified an Arkansas address as the individual's primary place of residence.
For individuals covered by a student health plan, Arkansas resident" means any
student enrolled in a student plan for an Arkansas college or university
regardless of his or her address of record;
(8) "Commissioner" means the person in charge
of the Arkansas Insurance Department;
(9) "Covered individual" means a natural
person who is an Arkansas resident and is eligible to receive medical, dental,
or pharmaceutical benefits under any policy, contract, certificate, evidence of
coverage, rider, binder, or endorsement that provides for or describes
coverage;
(10) "Data" means
information consisting of, or derived directly from enrollment files, medical
claims files, dental claims files, pharmacy claims files, provider files and
validation reports;
(11) "Data set"
means a collection of individual data records and data elements that comprises
the file types for an enrollment file, medical claims file, dental claims
files, pharmacy claims file, and a provider file submitted quarterly, and in
the format outlined in the DSG.
(12) "Data Submission Guide" or "DSG" means a
document approved by the Commissioner in consultation with the Initiative
Board, that sets forth the required data file format, data elements, code
tables, edit specifications, thresholds required for a submission to be deemed
complete, methods for submitting data, validation reports, exception processes,
adjustment files, and other information associated with the submitting
entities' reporting duties;
(13)
"Dental claims file" means, as further defined in the DSG, a data file that
contains service level remittance information for all paid and denied claims
for each billed dental service for covered individuals including without
limitation unique identifiers, geographic and demographic information but not
direct personal identifiers; provider information and services rendered to a
covered individual; charge/payment information; and clinical
diagnosis/procedure codes. Claims and benefits not subject to this Rule will
not be included in a dental claims file. The term may exclude certain data that
is prohibited to release according to state or federal law;
(14) "Direct personal identifiers" means
information relating to a covered individual that contains primary or obvious
identifiers, such as the individual's name, street address, e-mail address,
telephone number, and Social Security number. "Direct personal identifiers"
does not include geographic or demographic information that would not allow the
identification of a covered individual;
(15) "Enrollment file" means unique
identifiers, demographic and geographic information relating to covered
individuals;
(16) "HIPAA" means the
Health Insurance Portability and Accountability Act,
42
U.S.C. Section
1320d-
1320d-8
and its implementing regulations, 45 C.F.R. Parts
160,
162 and
164, as may be
amended;
(17) "Historical data"
means a one-time data submission following submission of a test file and for a
period commencing on January 1, 2013 and ending according to the data
submission schedule in this Rule;
(18) "Medical claims file" means, as further
defined in the DSG, a data file that contains service level remittance
information for all paid and denied claims for each billed medical service for
covered individuals including without limitation unique identifiers, geographic
and demographic information but not personal identifiers; provider information
and services rendered to a covered individual; charge/payment information; and
clinical diagnosis/procedure codes. Claims and benefits not subject to this
Rule will not be included in a medical claims file. The term may exclude
certain data that is prohibited to release according to state or federal
law;
(19) "Pharmacy claims file"
means a data file containing service level remittance information from all paid
and denied claims for each prescription for covered individuals including
without limitation unique identifiers, geographic and demographic information
but not personal identifiers; provider information; charge/payment information;
and national drug codes. The term may exclude certain data that is prohibited
to release according to state or federal law;
(20) "Provider file" means a data file that
includes additional information as set forth in the DSG about the providers
that are included in a medical claims file, dental claims file, or pharmacy
claims file;
(21) "Submitting
entity" means an entity that is subject to this Rule and its data reporting
requirements;
a. "Submitting entity" includes
the following entities:
i. an entity that
provides health or dental insurance or a health or dental benefit plan in the
state, including without limitation an insurance company, medical services
plan, hospital plan, hospital medical service corporation, health maintenance
organization, or fraternal benefits society, provided that the entity has
covered individuals and the entity had at least two thousand (2,000) covered
individuals as of December 31 in the previous calendar year;
ii. a health benefit plan offered or
administered by or on behalf of the state or an agency or instrumentality of
the state;
iii. a health benefit
plan offered or administered by or on behalf of the federal government with the
agreement of the federal government;
iv. the Arkansas Workers' Compensation
Commission;
v. any other entity
providing a plan of health insurance or medical, dental, or pharmaceutical
benefits subject to state insurance regulation, a third-party administrator, or
a pharmacy benefits manager, provided that the entity has covered individuals
and the entity had at least two thousand (2,000) covered individuals as of
December 31 in the previous calendar year; and
vi. an entity that contracts with
institutions of the Department of Correction or Department of Community
Correction to provide medical, dental, or pharmaceutical care to inmates;
vii. A health benefit plan subject
to the Employee Retirement Income Security Act of 1974,
Pub. L. No.
93-406 ("ERISA");
b. "Submitting entity" does not include an
entity that provides health insurance or a health benefit plan that is
accident-only, specified disease, hospital indemnity and other fixed indemnity,
long-term care, disability income, Medicare supplement, or other supplemental
benefit coverage from which benefit payments are directly to the covered
individual;
c. In instances where
more than one submitting entity is involved in the administration of a policy,
the payer shall be responsible for submitting the claims data on policies that
it has written or sold as a bundle, provided however that in instances where
more than one submitting entity is involved in the administration of a policy,
those entities will work together to use the same unique identifier for a
covered individual across separate feeds for medical, prescription, and other
claims; and
d. If a "submitting
entity" contracts with another entity to provide subcontracted claims
processing services, the entity which contracts directly with the customer
shall be the submitting entity for purposes of this Rule;
(22) "Test file" means a data file, as
further defined by the DSG, that includes a sample of service level remittance
information for billed medical or dental services or prescriptions for covered
individuals;
(23) "Unique
identifier" means, as further defined in the DSG, an identifier that is
guaranteed to be unique among all identifiers for covered individuals but does
not include direct personal identifiers;
(24) "Validation report" means, as further
defined in the DSG, a report from the submitting entity that provides
aggregated information about a quarterly data submission to provide control
totals and record counts.
Section
5.
General Reporting Requirements; Exemptions.
A.
Submitting Entity
Requirements. Unless exempted by the Commissioner in accordance with
Section 5.C of this Rule or by the explicit language of this Rule, a submitting
entity shall submit to the Arkansas Insurance Department through the
Administrator a completed data set for an enrollment file, a medical claims
file, a dental claims file, a pharmacy claims file, a provider file, and a
validation report in accordance with Section 5 of this Rule and with the
requirements outlined in the Data Submission Guide.
B.
Data Submission Timing.
Submitting entities shall provide data in accordance with the following
schedule:
1. Test files for submitting
entities must be submitted no later than January 1, 2016.
2. Historical data and regular quarterly
submission will commence following submission of test files according to the
submission schedule in Appendix A. For purposes of the submission schedule the
following groupings apply:
a. Group 1 means
submitting entities listed in the Definition Section 4(21)a.i. with at least
100,000 covered individuals as of December 31, 2015 and entities listed in the
Definition Section 4(21)a.ii., iii., iv., and vi.;
b. Group 2 means submitting entities listed
in Definition Section 4(21)a.i. with at least 25,000 covered individuals but
fewer than 100,000 covered individuals as of December 31,2015;
c. Group 3 means submitting entities listed
in Definition Section 4(21)a.i. with at least 10,000 covered individuals but
fewer than 25,000 covered individuals as of December 31, 2015;
d. Group 4 means submitting entities listed
in Definition Section 4(21)a.v. and submitting entities listed in Definition
Section 4(21)a.i. with at least 2,000 covered individuals but fewer than 10,000
covered individuals as of December 31,2015.
3. Unless otherwise exempted under Section
5.C of this Rule, submitting entities must submit data according to the
established patterns identified in the submission schedule in Appendix A for
future years not explicitly listed in the schedule.
4. Entities qualifying in more than one Group
listed in Section 5.B.2 must submit claims for all covered individuals
according to the schedule listed for the first Group in which the entity
qualifies.
C.
Submitting Entity Exemptions. An entity with fewer than two
thousand (2,000) covered individuals as of December 31 of the previous calendar
year will not be required to submit data in accordance with this Rule. For
purposes of determining whether an entity is subject to the requirements of
this rule and for data submission timing in Section 5.B of this Rule, entities
must aggregate the number of covered individuals for all companies at the Group
Code level as defined by the National Association of Insurance Commissioners.
Entities that offer medical, dental, and pharmaceutical benefits, or any
combination thereof, under separate or combined plans will count all covered
individuals, irrespective of the comprehensiveness of the plan, toward the two
thousand (2,000) covered individual threshold.
The Arkansas Workers' Compensation Commission is exempt from
submitting a provider file as required by this Section. Until further notice,
employer self-funded health plans are exempt from all requirements in this
Rule.
The Commissioner may, for good cause, grant an exemption to a
submitting entity (or to a class of which the entity is a member) for all or
some of the requirements of this Rule. "Good cause" includes without limitation
pending litigation which may preempt application of the Act to a submitting
entity. The Commissioner will respond in writing within 30 days to any
exemption request.
If an entity does not believe it meets the definition of a
submitting entity herein or does not believe it meets the 2,000 covered
individuals threshold, that entity may dispute the Commissioner's decision in
accordance with the administrative procedures of the State of Arkansas.
Section 6.
Submission Exclusions; Data Submission Guide.
A.
Extension, Variance or Waiver of
Data Submission Requirements. If a submitting entity is temporarily
unable to meet the requirements of this Rule including the standards in the
Data Submission Guide other than those outlined in the exceptions process in
the DSG for specific data variables, a submitting entity may submit an
exemption request to the Commissioner including the specific requirement to be
extended, varied or waived; an explanation of the reason or cause; the
methodology proposed to eliminate the necessity of the extension, variance or
waiver, if applicable; and the time frame required to come into compliance. The
Commissioner will respond in writing within 30 days to any exemption
request.
B.
Submission
Exclusions. For purposes of clarity and without limiting the foregoing,
the following data are excluded from this Rule; data related to a health
benefit plan that is accident-only, specified disease, hospital indemnity and
other fixed indemnity, long-term care, disability income, Medicare supplement,
or other supplemental benefit coverage where benefits are paid directly to the
covered individual.
Section
7.
Data Submission Guide.
A.
Data Submission Guide
Standards. The Administrator in consultation with the Initiative Board
will develop and make publicly available a Data Submission Guide that will be
used to evaluate data submissions, including minimum completion rates
("thresholds") as well as detailed information about criteria tested in
automated reviews. The Administrator will provide a periodic update of data
submission standards to facilitate submitting entities' creation of files that
conform to the DSG. In developing the DSG the Administrator will consult with
organizations such as the APCD Council in order to examine appropriate APCD
Core Standard provisions.
B.
Revisions to Data Submission Guide. The Administrator may make
material DSG revisions no more than once per year. Material DSG revisions
include adding new data elements, adding new codes to existing data elements or
otherwise significantly amending the DSG. Submitting entities will have 30 days
to review and comment on the proposed revisions. The Administrator will review
the comments with the Initiative Board and Commissioner prior to issuing a
revised DSG. The Initiative Board shall approve material DSG revisions. The
Commissioner will post a final revised version on the AID website. The revised
DSG will be effective for the files to be submitted not less than 120 days
after the posting date on the AID website.
The Administrator may make technical corrections to the DSG at
any time. Technical corrections are simple revisions to formatting of existing
data elements, the addition of codes to existing data elements, changes to
thresholds that can be accommodated by updated exceptions, and those intended
to clarify or otherwise expedite the process of submitting files that conform
to the DSG. Submitting entities will have 120 days to implement a technical
correction.
The Administrator will notify submitting entities about all
material and technical revisions, including the start and end of comment
periods for material revisions.
C.
Manner of Data Submission.
Submitting entities will submit data in accordance with the manner outlined in
the DSG and in compliance with the HIPAA Security Rule or any applicable state
law that is more restrictive than the HIPAA Security Rule.
Except as provided in this Rule, bulletin, order or directive
issued by the Commissioner, each submitting entity shall provide data in the
form and manner set forth in this Rule and according to the applicable version
of the Data Submission Guide and at such times set forth in any applicable
submission schedules.
Section
8.
Arkansas Healthcare Transparency Initiative Board;
Subcommittees.
A.
Initiative
Board Duties and Composition.
1. The
Initiative Board will serve in an advisory capacity, providing input into the
various functions of the Arkansas Healthcare Transparency Initiative and its
APCD, assisting in the development of and revisions to the Data Submission
Guide, and reviewing recommendations from the Data Oversight and Scientific
Advisory subcommittee regarding data use and release.
2. The Initiative Board will be composed of
the following members:
a. A representative of
the Arkansas Department of Human Services;
b. A representative of the Department of
Health;
c. A representative of the
Office of Health Information Technology or its successor entity;
d. The Arkansas Surgeon General; and
e. The following
Governor-appointed members:
i. Two
representatives from the health insurance industry, one of whom will be a
multi-state representative and one of whom will be a domestic
representative;
ii. A
representative from a self-insured employer;
iii. A representative from an employer of
fewer than one hundred (100) full-time employees that provides healthcare
coverage to employees through a fully-insured product;
iv. A representative from a healthcare
consumer organization;
v. A
representative from the academic research community with expertise in
healthcare claims data analysis; and
vi. An representative with expertise in
health data privacy and security.
3. Governor-appointed members of the
Initiative Board will serve a term of three (3) years. The Initiative Board
will appoint one (1) member as a chair and determine the qualifications, duties
and term of office for the chair. Seven (7) members constitute a quorum for a
meeting of the Initiative Board; provided however, that the lack of a quorum
does not preclude action by the Commissioner with respect to the duties
required by the Act or this Rule.
B.
Subcommittees.
1. The Data Oversight Committee, which will
be composed of three (3) Governor-appointed members and an individual
healthcare consumer appointed by the Commissioner, will review and make
recommendations to AID regarding:
a. Whether
specific data requests are consistent with the purpose and intent of the Act
1233, including without limitation whether the data request contains the
minimum required information; and
b. Reports and publications generated from
data requests to ensure compliance with the Act.
3. The Scientific Advisory Committee, which
will be composed of the Governor-appointed member of the Initiative Board from
the academic research community and two (2) nonmembers of the Initiative Board
who are academic researchers and appointed by the Commissioner, will serve as
peer review for academic researchers and provide advice regarding data requests
for academic proposals and the scientific rigor of analytic work.
4. The Commissioner may establish and convene
as necessary additional subcommittees to carry out the responsibilities of the
Act and this Rule.
Section
9.
Administrator. The Arkansas Center for Health
Improvement will host and administer the APCD and have custody of the data
collected by the APCD as part of the Arkansas Healthcare Transparency
Initiative. Except as authorized in state law, the Administrator is prohibited
from collecting, disclosing or using data obtained in its capacity as
Administrator for any purposes other than those specifically authorized in the
Act, this Rule, or any agreement with AID to administer the APCD.
Section 10.
Initiative Public Use and
Reports. Contingent upon available funding and in consultation with the
Initiative Board, the Arkansas Insurance Department will issue reports from
data collected by the Initiative which may include descriptions of patterns of
incidence and variation of medical treatment options, comparisons of health
care quality and performance, state and regional cost patterns, utilization of
services, how health care dollars are being spent and health care research
activities. Reports generated by AID will be available to the public on a
website.
Any and all reports will comply with federal and state privacy
laws. Any and all reports will preserve competition consistent with Statement 6
of the Department of Justice and Federal Trade Commission Enforcement Policy
and not deprive payers of existing trade secret protections.
After soliciting input from the Initiative Board, AID will
develop a process by which individuals can request data sets to be reviewed by
the Data Oversight Subcommittee and the Initiative Board and approved by the
Commissioner. Where appropriate, individuals requesting data sets will sign a
data use agreement to be approved or denied by the Commissioner, upon
recommendation of the Data Oversight Subcommittee and the Initiative Board. AID
will not release data sets for solely commercial purposes. The Commissioner may
adopt a fee schedule to fulfill data requests under this Section.
Section 11.
Limited Data Set
Requests. AID, in consultation with the Initiative Board, will determine
a limited data set of elements to be made available for research projects. The
requester will submit to the Scientific Advisory Committee through the
Administrator a detailed research scope and purpose to determine if a limited
data set can be made available. The Commissioner will approve or deny each
request for a Limited Data Set, upon recommendation by the Scientific Advisory
Committee and the Initiative Board. The requester will sign a data use
agreement with the Commissioner if data is supplied to the requestor.
The requester shall protect patient privacy and confidentiality
information contained in the limited data set according to HIPAA, applicable
laws of the Arkansas, and the data use agreement. The Commissioner may adopt a
fee schedule to fulfill the data requests under this Section.
Section 12.
Public Record. Data
submitted by submitting entities to the Arkansas Insurance Department through
the Administrator are confidential and are exempt from disclosure under the
Freedom of Information Act of 1967, Ark Code. Ann. §
25-19-101 et
seq., and are not subject to subpoena, except to the extent provided in Ark.
Code Ann §
23-61-205.
Section 13.
Compliance. Each
time a submitting entity submits a file, AID will evaluate each submitting
entity's submissions in accordance with the DSG. Upon completion of the
evaluation, AID will promptly notify each submitting entity in writing whether
its submissions satisfy the DSG standards. This notification shall identify the
specific files and the data sets that do not conform to DSG standards. Each
submitting entity notified of a non-compliant data submission shall respond
within 30 days of the notification by making the changes necessary to satisfy
the DSG standards unless an extension, variance or waiver has been submitted in
accordance with Section 6.B.
Section
14.
Penalties for Non-Compliance. Following notice to
the submitting entity and the failure to comply during the 30-day cure period,
the Commissioner may impose a maximum penalty on a submitting entity of one
thousand dollars ($1000.00) per day, not to exceed thirty thousand dollars
($30,000.00). The Commissioner may delay, reduce, or waive any penalty. The
Commissioner agrees to consider a lower maximum penalty per day than
authorized, including a waiver of the penalty, for test data and data receipts
due in the 2016 year, based upon the good cause of the submitting
entity.
Section 15.
Privacy
and Security. AID will institute appropriate administrative, physical
and technical safeguards to ensure that the APCD, its operations, data
collection and storage, and reporting disclosures are in compliance with the
requirements applicable federal and state law. AID will also ensure that the
Administrator and any vendors comply with applicable federal and state law
related to protecting patient privacy and confidentiality.
Section 16.
Effective Date. This
Rule will be effective on November 2, 2015.
APPENDIX A
SUBMISSION SCHEDULE
|
Group Number
|
Date of Data Receipt
|
Claims Dates
|
|
From:
|
To:
|
|
Group 1
|
3/31/2016
|
1/1/2013
|
12/31/2015
|
|
Group 2
|
6/30/2016
|
1/1/2013
|
12/31/2015
|
|
Group 3
|
9/30/2016
|
1/1/2013
|
12/31/2015
|
|
Group 4
|
12/31/2016
|
1/1/2013
|
12/31/2015
|
|
All Groups
|
3/31/2017
|
1/1/2016
|
12/31/2016
|
|
All Groups
|
6/30/2017
|
1/1/2017
|
3/31/2017
|
|
All Groups
|
9/30/2017
|
4/1/2017
|
6/30/2017
|
|
All Groups
|
12/31/2017
|
7/1/2017
|
9/30/2017
|
|
All Groups
|
3/31/2018
|
10/1/2017
|
12/31/2017
|
|
All Groups
|
6/30/2018
|
1/1/2018
|
3/31/2018
|
|
All Groups
|
9/30/2018
|
4/1/2018
|
6/30/2018
|
|
All Groups
|
12/31/2018
|
7/1/2018
|
9/30/2018
|
|
All Groups
|
3/31/2019
|
10/1/2018
|
12/31/2018
|
|
All Groups
|
6/30/2019
|
1/1/2019
|
3/31/2019
|
|
All Groups
|
9/30/2019
|
4/1/2019
|
6/30/2019
|
|
All Groups
|
12/31/2019
|
7/1/2019
|
9/30/2019
|
Data submitters who are newly required to submit files under this
rule after January 1, 2016 shall submit data according to a schedule developed
by the Administrator in consultation with AID.
