-IR- Database Guide
-IR- Database: Indiana Register

TITLE 760 DEPARTMENT OF INSURANCE

Notice of First Public Comment Period
LSA Document #24-151

ALL PAYER CLAIMS DATA BASE SUBMISSION REQUIREMENTS


PURPOSE OF NOTICE
The Indiana Department of Insurance (IDOI) is soliciting public comment on adding rules at 760 IAC 1-83 concerning the Indiana all payer claims data base (APCD). The IDOI seeks comment on the affected citations listed and any other provisions of Title 27 that may be affected by this rulemaking.

CITATIONS AFFECTED: 760 IAC 1-83

AUTHORITY: IC 27-1-44.5-11

OVERVIEW
Basic Purpose and Background
The IDOI is charged with administering the APCD. The APCD is a large scale database that collects and aggregates significant amounts of health care data, including eligibility data, medical claims, pharmacy prescription drug claims, non-fee for service information, and health care provider data. The data collected by the APCD is intended to be used to help identify needs in health care and improve the quality and affordability of health care and health care coverage for Hoosiers. The proposed rule sets forth registration and data submission requirements for health payers and includes a provision allowing a civil penalty to be imposed for noncompliance with the proposed rule. The proposed rule impacts health payers, as defined in IC 27-1-44.5-2, including health insurers, pharmacy benefit managers, multiple employer welfare arrangements, and employee benefit plans subject to the federal Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.), including a third party administrator.

For purposes of IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator:
Meggan Brumbaugh
General Counsel
Indiana Department of Insurance
311 West Washington Street, Suite 103
Indianapolis, IN 46204
(317) 234-6476
mbrumbaugh@idoi.in.gov
For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-6 is:
Matthew Jaworowski
Small Business Ombudsman
Indiana Economic Development Corporation
One North Capitol, Suite 700
Indianapolis, IN 46204
(317) 650-0126
majaworowski@iedc.in.gov
Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-6, specifically IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator.

REQUEST FOR PUBLIC COMMENTS
At this time, IDOI is soliciting public comments for this rule. Comments may be submitted in one of the following ways:
(1) By mail or common carrier to the following address:
LSA Document #24-151 All Payer Claims Data Base Submission Requirements
Meggan Brumbaugh
General Counsel
Indiana Department of Insurance
311 West Washington Street, Suite 103
Indianapolis, IN 46204
(317) 234-6476
(2) By electronic mail to mbrumbaugh@idoi.in.gov. To confirm timely delivery of submitted comments, please request a document receipt when sending the electronic mail. PLEASE NOTE: Electronic mail comments will not be considered part of the official written comment period unless they are sent to the address indicated in this notice.
(3) Attend scheduled public hearing.

COMMENT PERIOD DEADLINE
All comments must be postmarked or time stamped not later than May 17, 2024.

The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Department of Insurance, 311 West Washington Street, Suite 103, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the office of the Department of Insurance.

If the IDOI does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice.

ADDITIONAL DOCUMENTS

Regulatory Analysis: 20240417-IR-760240151RAA

Notice of Public Hearing: 20240417-IR-760240151PHA

PROPOSED RULE

SECTION 1. 760 IAC 1-83 IS ADDED TO READ AS FOLLOWS:

Rule 83. All Payer Claims Data Base Submission Requirements


760 IAC 1-83-1 Applicability of definitions

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 1. The definitions in this rule apply throughout this rule.
(Department of Insurance; 760 IAC 1-83-1)


760 IAC 1-83-2 "Administrator" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5-0.2

Sec. 2. "Administrator" has the meaning set forth in IC 27-1-44.5-0.2.
(Department of Insurance; 760 IAC 1-83-2)


760 IAC 1-83-3 "APCD" or "data base" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5-1

Sec. 3. "APCD" or "data base" has the meaning set forth in IC 27-1-44.5-1.
(Department of Insurance; 760 IAC 1-83-3)


760 IAC 1-83-4 "APCD-CDL™" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 4. "APCD-CDL™" means the common data layout for all payer claims databases, as developed by the University of New Hampshire and the National Association of Health Data Organizations, Version 2.1, released July 1, 2021, and hereby incorporated by reference. For purposes of this rule, a reference to an individual's Social Security number in the APCD-CDL™ means the last four (4) digits of the individual's Social Security number.
(Department of Insurance; 760 IAC 1-83-4)


760 IAC 1-83-5 "Department" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 5. "Department" means the Indiana department of insurance.
(Department of Insurance; 760 IAC 1-83-5)


760 IAC 1-83-6 "Designated submitter" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 6. "Designated submitter" means an entity designated by a health payer or voluntarily participating entity to:
(1) submit data to the APCD on behalf of the health payer or voluntarily participating entity; and
(2) receive communications from the administrator and department regarding the health payer's or voluntarily participating entity's APCD data submissions.
(Department of Insurance; 760 IAC 1-83-6)


760 IAC 1-83-7 "Designated submitter representative" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec.7. "Designated submitter representative" means an individual or the individuals authorized by a designated submitter to:
(1) submit data to the APCD on behalf of the health payer or voluntarily participating entity; and
(2) receive communications from the administrator and department regarding the health payer's or voluntarily participating entity's APCD data submissions.
(Department of Insurance; 760 IAC 1-83-7)


760 IAC 1-83-8 "Eligibility file" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 8. "Eligibility file" means a file that includes data about each member residing in Indiana, based on the requirements contained in the submission guide.
(Department of Insurance; 760 IAC 1-83-8)


760 IAC 1-83-9 "ERISA" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 9. "ERISA" means the federal Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.).
(Department of Insurance; 760 IAC 1-83-9)


760 IAC 1-83-10 "ERISA plan" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 10. "ERISA plan" means an employee benefit plan that is subject to ERISA. For purposes of this rule, the term includes a third party administrator of an employee benefit plan.
(Department of Insurance; 760 IAC 1-83-10)


760 IAC 1-83-11 "Executive director" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5-1.2

Sec. 11. "Executive director" has the meaning set forth in IC 27-1-44.5-1.2.
(Department of Insurance; 760 IAC 1-83-11)


760 IAC 1-83-12 "Health payer" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5-2

Sec. 12. "Health payer" has the meaning set forth in IC 27-1-44.5-2.
(Department of Insurance; 760 IAC 1-83-12)


760 IAC 1-83-13 "Health plan" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 13. "Health plan" means health insurance coverage offered to a member by a health payer.
(Department of Insurance; 760 IAC 1-83-13)


760 IAC 1-83-14 "Historical and catch-up data" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 14. "Historical and catch-up data" means:
(1) eligibility files;
(2) medical claims files;
(3) pharmacy claims files; and
(4) provider files;
submitted to the APCD by a submitter for the period specified in this rule.
(Department of Insurance; 760 IAC 1-83-14)


760 IAC 1-83-15 "Medical claims file" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 15. "Medical claims file" means a file that includes data about medical claims and other encounter information, based on the requirements contained in the submission guide.
(Department of Insurance; 760 IAC 1-83-15)


760 IAC 1-83-16 "Member" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 16. "Member" means an individual covered by, or enrolled in a health plan administered by, a health payer.
(Department of Insurance; 760 IAC 1-83-16)


760 IAC 1-83-17 "Pharmacy claims file" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 17. "Pharmacy claims file" means a file that includes data about prescription medications and claims filed by pharmacies, based on the requirements contained in the submission guide.
(Department of Insurance; 760 IAC 1-83-17)


760 IAC 1-83-18 "Plan size submission threshold" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 18. "Plan size submission threshold" means an aggregate total of at least three thousand (3,000) members under a health payer.
(Department of Insurance; 760 IAC 1-83-18)


760 IAC 1-83-19 "Provider file" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 19. "Provider file" means a file that includes additional information about the individuals and entities included in the medical claims file, pharmacy claims file, or eligibility file, and submitted based on the requirements contained in the submission guide.
(Department of Insurance; 760 IAC 1-83-19)


760 IAC 1-83-20 "Submission guide" or "data submission guide" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 20. "Submission guide" or "data submission guide" means the document entitled "Indiana All Payer Claims Database Data Submission Companion Guide", Version 1.1, updated September 2023 and hereby incorporated by reference, developed by the administrator setting forth the required schedules, data file format, record specifications, data elements, and definitions for submitting:
(1) eligibility files;
(2) medical claims files;
(3) pharmacy claims files and
(4) provider data files;
to the APCD.
(Department of Insurance; 760 IAC 1-83-20)


760 IAC 1-83-21 "Submitter" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 21. "Submitter" includes the following:
(1) Health payers meeting the plan size submission threshold.
(2) Voluntarily participating entities.
(3) Entities appointed as:
(A) designated submitters; or
(B) designated submitter representatives;
of entities described in subdivisions (1) and (2).
(Department of Insurance; 760 IAC 1-83-21)


760 IAC 1-83-22 "Third party administrator" defined

Authority: IC 27-1-44.5-11

Sec. 22. "Third party administrator" has the meaning set forth in IC 27-1-25-1(a).
(Department of Insurance; 760 IAC 1-83-22)


760 IAC 1-83-23 "Voluntarily participating entity" defined

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 23. "Voluntarily participating entity" means an entity:
(1) not required to submit data;
(2) that chooses to voluntarily submit data; and
(3) approved by the department to submit data;
to the APCD.
(Department of Insurance; 760 IAC 1-83-23)


760 IAC 1-83-24 Procedures for voluntary participation

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 24. (a) To request to become a voluntarily participating entity, an entity shall submit a request to the administrator to participate in the APCD through the data portal.

(b) A request described in subsection (a) must include the following information related to the voluntarily participating entity:
(1) Business type.
(2) Number of members.
(3) Types of coverage offered.
(4) Contact information.

(c) The administrator shall notify the requesting entity of the department's determination.
(Department of Insurance; 760 IAC 1-83-24)


760 IAC 1-83-25 General provisions

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 25. (a) A health payer not meeting the plan size submission threshold is exempt from the submission requirements set forth in sections 28, 29, and 34 of this rule. The number of Indiana members is calculated by adding together the Indiana members in all the entity's health plans as of December 31 each calendar year. Additional changes in the data submission guide will allow an eighty (80) calendar day window to submit data after the approved and final publications of the data submission guide.

(b) A health payer dropping below the plan size submission threshold as of December 31 shall submit data files to the APCD for data through December 31 of that calendar year. The health payer shall notify the APCD of its change in status and may elect to become a voluntarily participating entity.

(c) A previously exempt health payer no longer exempt by meeting the plan size submission threshold as of December 31 shall submit data files to the APCD to report the next calendar year's data.

(d) A newly created health payer meeting the plan size submission threshold December 31 of the year when it is created shall submit data files to the APCD to report the next calendar year's data.
(Department of Insurance; 760 IAC 1-83-25)


760 IAC 1-83-26 Coordination of data submissions

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 26. (a) If a health payer contracts with other entities to administer plan benefits, the health payer has sole responsibility for the timely submission of the data to the APCD. The health payer shall either:
(1) obtain the necessary data from the contracted entity and submit the data to the APCD; or
(2) ensure the contracted entity submits the data directly to the APCD.

(b) A health payer shall identify contracted entities through the registration process. Each contracted entity shall register as set forth in section 27 or 34 of this rule, as applicable. This entity is referred to as a designated submitter.
(Department of Insurance; 760 IAC 1-83-26)


760 IAC 1-83-27 Data portal registration

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 27. (a) Health payers shall register in the data portal and review and update, or confirm, the registration information before February 1 each year after the year of its initial registration.

(b) When a health payer becomes subject to this rule, it shall register at least sixty (60) calendar days before its first data files are due.

(c) A voluntarily participating entity shall register to submit data to the data portal. Before registering, the entity must have been approved to submit data under section 24 of this rule.

(d) Submitters shall:
(1) register through the data portal;
(2) provide the required information as specified in the data submission guide; and
(3) update registration information;
within fifteen (15) calendar days of any change in the required contact information.
(Department of Insurance; 760 IAC 1-83-27)


760 IAC 1-83-28 Monthly data file submission requirements

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5-2

Sec. 28. (a) Submitters shall submit data files monthly through the data portal. A monthly file must be submitted by the first business day of the second month after the report month.

(b) The following files, as specified in the data submission guide, in conjunction with the APCD-CDL™, must be submitted:
(1) Eligibility files.
(2) Medical claims files.
(3) Pharmacy claims files.
(4) Provider files.

(c) Files must exclude data for members only enrolled in the types of coverages set forth in IC 27-1-44.5-2(3)(A) through IC 27-1-44.5-2(3)(H).

(d) Data files must comply with file format, technical specifications, and other standards specified in the data submission guide, in conjunction with the APCD-CDL™.

(e) If a submitter has identified at least one (1) designated submitter or designated submitter representative to submit information directly to the data portal on their behalf, the data submission is not considered finished until the required files have been received.

(f) Submitters shall use the data portal to submit test files to confirm and test their ability to create data files meeting the standards set forth in the data submission guide. Test files will be identified as specified in the data submission guide. Test files will not be considered to have been submitted to the APCD.
(Department of Insurance; 760 IAC 1-83-28)


760 IAC 1-83-29 Historical data submission requirements

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 29. (a) A submitter shall use the test function to prepare for submitting historical and catch-up data files. This testing process must be successfully finished before July 1, 2023.

(b) Submitters shall submit historical and catch-up data files as set forth in section 28 of this rule for the period beginning January 1, 2020, through July 31, 2023, before September 1, 2023. Additional changes in the data submission guide will be announced with an eighty (80) calendar day window for submitters to prepare, reprogram, test, and submit production data.

(c) Submitters shall begin regular monthly reporting with monthly data files for August 2023 before October 3, 2023. Additional changes in the data submission guide will be announced with an eighty (80) calendar day window for submitters to prepare, reprogram, test, and submit production data.
(Department of Insurance; 760 IAC 1-83-29)


760 IAC 1-83-30 Data acceptance

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 30. Data files submitted to the data portal but not meeting the file intake specifications detailed in the data submission guide will not be accepted. Submitters will be notified within two (2) business days after submission whether a data file has been accepted or rejected.
(Department of Insurance; 760 IAC 1-83-30)


760 IAC 1-83-31 Data correction and resubmission

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 31. If the administrator determines a previously accepted file contains initially unidentified errors, the administrator shall notify the submitter. The submitter shall address the issues identified by the administrator by either:
(1) explaining to the administrator and providing supporting documentation, as necessary, showing the file is correct as initially submitted; or
(2) correcting and resubmitting the file within thirty (30) calendar days after notification by the administrator.
(Department of Insurance; 760 IAC 1-83-31)


760 IAC 1-83-32 Variances

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 32. (a) A submitter unable to submit data files meeting the standards set forth in the data submission guide may request a temporary variance to those requirements.

(b) Variance requests may only be submitted through the data portal, and must clearly identify the following with the data submission guide requirements:
(1) The nature of the issues.
(2) The plan for correction of the issues.
(3) The anticipated date of compliance.

(c) An administrator shall either approve or disapprove variance requests meeting the requirements of subsection (b) within five (5) calendar days after the date the request was submitted.
(Department of Insurance; 760 IAC 1-83-32)


760 IAC 1-83-33 Violations; penalties

Authority: IC 27-1-44.5-11

Sec. 33. (a) If a health payer fails to:
(1) submit required data to the APCD;
(2) submit required data passing the data quality validations or variances under the:
(A) submission guide and APCD-CDL™; or
(B) periods outlined in this rule;
(3) register for the APCD; or
(4) correct submissions rejected because of errors;
the administrator shall give written notice of the nature of the violation and required steps to cure the violation to the health payer by registered or certified mail, return receipt requested, and copy the executive director on the written notice.

(b) If a health payer fails to provide the required information set forth in the written notice described in subsection (a) within thirty (30) calendar days after receiving the notice, the administrator shall give written notice of the failure to report to the health payer by registered or certified mail, return receipt requested and notify the executive director of the health payer's failure to report.

(c) The executive director may assess a penalty for uncured violations of up to:
(1) one hundred dollars ($100) a day, for each issue, for the first thirty (30) days a health payer fails to provide the required data to the APCD, beginning on the date the health payer receives written notice of the failure to report described in subsection (b); and
(2) one thousand dollars ($1,000) for each day thereafter.
In determining whether to impose a penalty, the executive director may consider mitigating factors, including the reasons for the failure to report and the detrimental impact on the public purpose served by the APCD.

(d) If the failure to perform any of the actions set forth in subsection (a) is a result of the action or inaction of a contracted entity identified as a designated submitter or a designated submitter representative, the penalty is assessed to the health payer.

(e) The penalties specified in this section do not apply to voluntarily participating entities.

(f) Penalties will be deposited into the department of insurance fund created by IC 27-1-3-28.
(Department of Insurance; 760 IAC 1-83-33)


760 IAC 1-83-34 Provisions applicable to ERISA plans in effect after June 30, 2023

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 34. (a) This section applies only to ERISA plans in effect after June 30, 2023.

(b) Section 29 of this rule does not apply to ERISA plans.

(c) An ERISA plan must register to submit data to the data portal. An ERISA plan must:
(1) finish its initial registration with the APCD before September 1, 2023; and
(2) review and update, or confirm, the registration information before February 1 each year thereafter.

(d) A submitter shall use the test function to prepare for submitting historical and catch-up data files. This testing process must be successfully finished before November 1, 2023.

(e) Submitters shall submit historical and catch-up data files as set forth in section 28 of this rule for the period beginning January 1, 2020, through December 31, 2023, before April 1, 2024.

(f) Submitters shall begin regular monthly reporting with monthly data files for January 2024.
(Department of Insurance; 760 IAC 1-83-34)


760 IAC 1-83-35 Severability

Authority: IC 27-1-44.5-11
Affected: IC 27-1-44.5

Sec. 35. If a section or part of a section of this rule, or its applicability to any person or circumstance, is held invalid by a court, the remainder of the rule or the applicability of the provision to other persons or circumstances is not affected.
(Department of Insurance; 760 IAC 1-83-35)


Posted: 04/17/2024 by Legislative Services Agency

DIN: 20240417-IR-760240151FNA
Composed: Jun 30,2024 10:15:32PM EDT
A PDF version of this document.