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Vermont Healthcare Claims Uniform Reporting and Evaluation System ("VHCURES")

Regulation
Tuesday, September 30, 2008
Reg-H-2008-01

REGULATION H-2008-01

Vermont Healthcare Claims Uniform Reporting and Evaluation System (“VHCURES”)

 

Section 1: Purpose

The purpose of this rule is to set forth the requirements for the submission of health care claims data, member eligibility data, and other information relating to health care provided to Vermont residents or by Vermont health care providers and facilities by health insurers, managed care organizations, third party administrators, pharmacy benefit managers and others to the Department of Banking, Insurance, Securities and Health Care

Administration and conditions for the use and dissemination of such claims data, all as required by and consistent with the purposes of 18 V.S.A. §9410.

Section 2: Authority

This rule is issued pursuant to the authority vested in the Commissioner of the Department of Banking, Insurance, Securities and Health Care Administration by 18

V.S.A. §9410, as well as 8 V.S.A. §15 and other applicable portions of Chapter 221 of Title 18.

Sectio n 3: Definitions

As used in this Rule

A. “BISHCA” or “Department” means the Vermont Department of Banking, Insurance, Securities and Health Care Administration.

B. “Capitated services” means services rendered by a provider through a contract in which payment are based upon a fixed dollar amount for each member on a monthly basis.

C. “Cell size” means the count of persons that share a set of characteristics contained in a statistical table.

D. “Charge” means the actual dollar amount charged on the claim.

E. "Co-insurance" means the percentage a member pays toward the cost of a covered service.

F. “Commissioner” means the commissioner of the Department of Banking, Insurance, Securities and Health Care Administration or his or her designee.

G. "Co-payment" means the fixed dollar amount a member pays to a health care provider at the time a covered service is provided or the full cost of a service when that is less than the fixed dollar amount.

H. “Current Procedural Terminology (CPT)” means a medical code set of physician and other services, maintained and copyrighted by the American Medical Association (AMA), and adopted by the U.S. Secretary of Health and Human Services as the standard for reporting physician and other services on standard transactions.

I. “Data set” means a collection of individual data records, whether in electronic or manual files.

J. “Deductible” means the total dollar amount a member pays towards the cost of covered services over an established period of time before the contracted third- party payer makes any payments.

K. “De-identified health information” means information that does not identify an individual patient, member or enrollee and with respect to which no reasonable basis exists to believe that the information can be used to identify an individual patient, member or enrollee. De-identification means that health information is not individually identifiable and requires the removal of Direct Personal Identifiers associated with patients, members or enrollees.

L. “Direct personal identifiers” is information relating to an individual patient, member or enrollee that contains primary or obvious identifiers, including:

(1) Names;

(2) Business names when that name would serve to identify a person;

(3) Postal address information other than town or city, state, and 5-digit zip code;

(4) Specific latitude and longitude or other geographic information that would be used to derive postal address;

(5) Telephone and fax numbers;

(6) Electronic mail addresses;

(7) Social security numbers;

(8) Vehicle Identifiers and serial numbers, including license plate numbers;

(9) Medical record numbers;

(10) Health plan beneficiary numbers;

(11) Certificate and license numbers;

(12) Internet protocol (IP) addresses and uniform resource locators (URL) that identify a business that would serve to identify a person;

(13) Biometric identifiers, including finger and voice prints; and

(14) Personal photographic images.

M. “Disclosure” means the release, transfer, provision of access to, or divulging in any other manner of information outside the entity holding the information.

N. “Encrypted identifier” is a code or other means of record identification to allow patients, members or enrollees to be tracked across the data set without revealing their identity. Encrypted identifiers are not direct identifiers.

O. "Encryption" means a method by which the true value of data has been disguised in order to prevent the identification of persons or groups, and which does not provide the means for recovering the true value of the data.

P. “Health benefit plan” means a policy, contract, certificate or agreement entered into, or offered by a health insurer to provide, deliver, arrange for, pay for or reimburse any of the costs of health care services.

Q. “Healthcare claims data” means information consisting of or derived directly from member eligibility files, medical claims files, pharmacy claims files and other related data pursuant to the Vermont Healthcare Claims Uniform Reporting and Evaluation System (VHCURES) in effect at the time of the data submission. “Healthcare claims data” does not include analysis, reports, or studies containing information from health care claims data sets if those analyses, reports, or studies have already been released in response to another request for information or as part of a general distribution of public information by BISHCA.

R. “Healthcare premium” means the dollar amount charged for any policies offered by health insurers which partially or fully cover the cost of health care services.

S. “Healthcare Common Procedure Coding System (HCPCS)” means a medical code set that identifies health care procedures, equipment, and supplies for claim submission purposes. These are often known as "local codes".

T. “Health care” means care, services, or supplies related to the health of an individual. It includes but is not limited to (1) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual or that affects the structure or function of the body; and (2) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription [45 CFR § 160.103].

U. “Health care facility” shall be defined as per 18 V.S.A §9432, as amended from time to time.

V. "Health care provider" means a person, partnership, corporation, facility or institution, licensed or certified or authorized by law to provide professional health care service in this state to an individual during that individual's medical care, treatment or confinement, as per 18 V.S.A. §9432.

W. “Health information” means any information, whether oral or recorded in any form or medium, that 1) is created or received by a health-care provider, health plan, public health authority, employer, life insurer, school or university, or health-care clearinghouse; and 2) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual shall be as defined in 45 CFR § 160.103.

X. “Health insurer” means those entities defined in 18 V.S.A. §§ 9402 and 9410(j)(1), and includes any health insurance company, nonprofit hospital and medical service corporation, managed care organization, third party administrator, pharmacy benefit manager, and any entity conducting administrative services for business or possessing claims data, eligibility data, provider files, and other information relating to health care provided to Vermont residents or by Vermont health care providers and facilities. The term may also include, to the extent permitted under federal law, any administrator of an insured, self-insured, or publicly funded health care benefit plan offered by public and private entities.

Y. “HIPAA” means the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191.

Z. “Indirect personal identifiers” means information relating to an individual patient, member or enrollee that a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods could apply to render such information individually identifiable by using such information alone or in combination with other reasonably available information.

Aa. “International Classification of Diseases” or “ICD” shall mean that medical code set maintained by the World Health Organization..

Ab. “Mandated Reporter” means a health insurer as defined herein and at 18 V.S.A.

§9410(j)(1) with two hundred (200) or more enrolled or covered members in each month during a calendar year, including both Vermont residents and any non- residents receiving covered services provided by Vermont health care providers and facilities.

Ac. “Medical claims file” means a data file composed of service level remittance information for all non-denied adjudicated claims for each billed service including, but not limited to member demographics, provider information, charge/payment information, and clinical diagnosis and procedure codes, and shall include all claims related to behavioral or mental health.

Ad. “Member” means the insured subscriber and any spouse and/or dependent covered by the subscriber's policy.

Ae. “Member eligibility file” means a data file containing demographic information for each individual member eligible for medical or pharmacy benefits for one or more days of coverage at any time during the reporting month.

Af. “Patient” means any person in the data set that is the subject of the activities of the claim performed by the health care provider.

Ag. “Payer” means a third-party payer or third-party administrator.

Ah. “Payment” means the actual dollar amount paid for a claim by a health insurer.

Ai. “Personal identifiers” means information relating to an individual that contains direct or indirect identifiers to which a reasonable basis exists to believe that the information can be used to identify an individual.

Aj. “Pharmacy Benefit Manager” or “PBM” means a person or entity that performs pharmacy benefit management as that term is defined at 18 V.S.A. §9471(4). The term includes a person or entity in a contractual or employment relationship with an entity performing pharmacy benefit management for a health plan.

Ak. “Pharmacy claims file” means a data file containing service level remittance information from all non-denied adjudicated claims for each prescription including, but not limited to: member demographics; provider information; charge/payment information; and national drug codes.

Al. "Prepaid amount" means the fee for the service equivalent that would have been paid for a specific service if the service had not been capitated.

Am. “Principal Investigator” means the person in charge of a project that makes use of limited use research health care claims data sets. The principal investigator is the custodian of the data and is responsible for compliance with all restrictions, limitations and conditions of use associated with the data release.

An. “Public Use Data Set” means a publicly available data set containing only the public use data elements specified in this Rule as unrestricted data elements in Appendix J.

Ao. “Reporter” means a health insurer as defined herein and at 18 V.S.A. §9410(j)(1), and shall include Voluntary Reporters as defined herein.

Ap. “Subscriber” means the individual responsible for payment of premiums or whose employment is the basis for eligibility for membership in a health benefit plan.

Aq. “Third-party Administrator” means any person who, on behalf of a health insurer or purchaser of health benefits, receives or collects charges, contributions or premiums for, or adjusts or settles claims on or for residents of this State or Vermont health care providers and facilities.

Ar. “Vermont Healthcare Claims Uniform Reporting and Evaluation System” or “VHCURES” means the Department’s system for the collection, management and reporting of eligibility, claims and related data submitted pursuant to 18

V.S.A. § 9410.

As. “Voluntary Reporter” includes any entity other than a mandated reporter, including any health benefit plan offered or administered by or on behalf of the federal government where such plan, with the agreement of the federal government, voluntarily submits data to the BISHCA commissioner for inclusion in the database on such terms as may be appropriate.


Section 4: Reporting Requirements

Registration and Reporting Requirements

A. VHCURES Reporter Registration. On an annual basis prior to December 31, Health Insurers shall register with the Department on a form established by the Commissioner and identify whether health care claims are being paid for members who are Vermont residents and whether health care claims are being paid for non-residents receiving covered services from Vermont health care providers or facilities. Where applicable, the completed form shall identify the types of files to be submitted per Section 5. This form shall be submitted to BISHCA or its designee. See Appendix F.

B. Third Party Administrator Registration. Any person or entity that provides third party administration services, a third party administrator or “TPA” as defined in Section 3, shall register with the Department on a form established by the Commissioner, both before doing business in Vermont and on an annual basis prior to December 31 thereafter. 18 V.S.A. §9410. See Appendix G.

C. Pharmacy Benefit Manager Registration. Any person or entity that performs pharmacy benefit management (a pharmacy benefit manager or “PBM”) shall register with the Department on a form established by the Commissioner both before doing business in Vermont and on an annual basis prior to December 31. 18 V.S.A. §9421. The registration requirement includes persons or entities in a contractual or employment relationship with a health insurer or PBM performing pharmacy benefit management for a health plan with Vermont enrollees or beneficiaries. 18 V.S.A. §9471. See Appendix H.

D. Health Insurers shall regularly submit medical claims data, pharmacy claims data, member eligibility data, provider data, and other information relating to health care provided to Vermont residents and health care provided by Vermont health care providers and facilities to both Vermont residents and non-residents in specified electronic format to the Department for each health line of business (Comprehensive Major Medical, TPA/ASO, Medicare Supplemental, Medicare Part C, and Medicare Part D) per the data submission requirements contained in the appendices to this Rule.

E. Voluntary Reporters may, with the permission of the Commissioner, participate in VHCURES and submit medical claims files, pharmacy claims files, member eligibility files, provider data, and other information relating to health care provided to Vermont residents and health care provided by Vermont health care providers and facilities to both Vermont residents and non-residents in specified electronic format to the Department per the data submission requirements contained in the appendices to this Rule.


Section 5: Required Healthcare Data Files

Mandated Reporters shall submit to BISHCA or its designee health care claims data for all members who are Vermont residents and all non-residents who received covered services provided by Vermont health care providers or facilities in accordance with the requirements of this section. Each Mandated Reporter is also responsible for the submission of all health care claims processed by any sub-contractor on its behalf unless such subcontractor is already submitting the identical data as a Mandated Reporter in its own right. The health care claims data submitted shall include, where applicable, a member eligibility file containing records associated with each of the claims files reported: a medical claims file and a pharmacy claims file. The data submitted shall also include supporting definition files for payer specific provider specialty taxonomy codes and procedure and/or diagnosis codes.

A. General Requirements for Data Submission

(1) Adjustment Records. Adjustment records shall be reported with the appropriate positive or negative fields with the medical and pharmacy claims file submissions. Negative values shall contain the negative sign before the value. No sign shall appear before a positive value.

(2) Behavioral or Mental Health Claims. All claims related to behavioral or mental health shall be included in the medical claims file.

(3) Capitated Service Claims. Claims for capitated services shall be reported with all medical and pharmacy claims file submissions.

(4) Claims Records. Records for the medical and pharmacy claims file submissions shall be reported at the visit, service, or prescription level. The submission of the medical and pharmacy claims is based upon the paid dates and not upon the dates of service associated with the claims.

(5) Codes and Encryption Requirements

(a) Code Sources. Unless otherwise specified in this regulation, the code sources listed and described in Appendix A shall be utilized in association with the member eligibility file and medical and pharmacy claims file submissions.

(b) Member Identification Code. Reporters shall assign to each of their members a unique identification code that is the member’s social security number. If a Reporter does not collect the social security numbers for all members, the Reporter shall use the social security number of the subscriber and then assign a discrete two- digit suffix for each member under the subscriber’s contract.

If the subscriber’s social security number is not collected by the Reporter, a version of the subscriber’s certificate or contract number shall be used in its place. The discrete two-digit suffix shall also be used with the certificate or contract number. The certificate or contract number with the two-digit suffix shall be at least eleven but not more than sixty-four characters in length.

The social security number of the member/ subscriber and the subscriber and member names shall be encrypted prior to submission by the Reporter utilizing a standard encryption methodology provided by BISHCA or its designee. The unique member identification code assigned by each Reporter shall remain with each member/subscriber for the entire period of coverage for that individual.

(c) Specific/Unique Coding. With the exception of provider, provider specialty, and procedure/diagnosis codes, specific or unique coding systems shall not be permitted as part of the health care claims data set submission.

(6) Co-Insurance/Co-Payment. Co-insurance and co-payment are to be reported in two separate fields in the medical and pharmacy claims file submissions.

(7) Coordination of Benefits Claims. Claims where multiple parties have financial responsibility shall be included with all medical and pharmacy claims file submissions.

(8) Denied Claims. Denied claims shall be excluded from all medical and pharmacy claims file submissions. When a claim contains both fully processed/paid service lines and partially processed or denied service lines, only the fully processed/paid service lines shall be included as part of the health care claims data set submittal.

(9) Eligibility Records. Records for the member eligibility file submission shall be reported at the individual member level with one record submitted for each claim type. If a member is covered as both a subscriber and a dependent on two different policies during the same month, two records must be submitted. If a member has 2 contract numbers for 2 different coverage types, 2 member eligibility records shall be submitted.

(10) Exceptions.

(a) Medical Claims File Exclusions. All claims related to services provided under stand-alone health care policies shall be excluded if the services are not covered by comprehensive medical insurance policies and are provided on a stand-alone basis for:

1. Specific disease;

2. Accident:

3. Injury;

4. Hospital indemnity;

5. Disability:

6. Long-term care;

7. Student liability;

8. Vision coverage; or

9. Durable medical equipment.

(b) Claims for pharmacy services containing national drug codes are to be included in the pharmacy claims file, but excluded from the medical claims file.

(c) Member Eligibility File Exclusions. Members without medical or pharmacy coverage for the month reported shall be excluded.

(11) File Format. Each file submission shall be an ASCII file, variable field length, and asterisk delimited. When asterisks are used in any field values, the entire value shall be enclosed in double quotes.

(12) Insured Group or Policy Number Key Look-up Table. Reporters are required to submit a key look-up table when submitting member eligibility files. The key look-up table shall link Insured Group or Policy Number (ME006) to the name of the group associated with each Insured Group or Policy Number, but shall not identify any individual policyholders in connection with non-group policies.

(13) Header and Trailer Records. Each member eligibility file and each medical and pharmacy claims file submission shall contain a header record and a trailer record. The header record is the first record of each separate file submission and the trailer record is the last. The header and trailer record formats shall be as detailed in Appendices B-1 and B-2.

(14) Pharmacy Claims. Claims for pharmacy services shall be included in the following files:

(a) If the pharmacy claims are covered under the medical benefit then the claim shall be included in the medical claims file and not the pharmacy claims file; and

(b) If the claim is covered under the prescription benefit then the claim shall be included in the pharmacy claims file.

(15) Prepaid Amount. Any prepaid amounts are to be reported in a separate field in the medical and pharmacy claims file submissions.

(16) Supplemental Health Insurance. Claims related to supplemental health insurance are to be included if the policies are for health care services entirely excluded by the Medicare, Tricare, or other publicly funded health benefit programs.


B. Detailed File Specifications.

(1) Filled Fields. All required fields shall be filled where applicable. Non- required text, date, and integer fields shall be set to null when unavailable. Non-applicable decimal fields shall be filled with one zero and shall not include decimal points when unavailable.

(2) Position. All text fields are to be left justified. All integer and decimal fields are to be right justified.

(3) Signs. Positive values are assumed and need not be indicated as such.

Negative values must be indicated with a minus sign and must appear in the left-most position of all integer and decimal fields. Over-punched signed integers or decimals are not to be utilized.

(4) Individual Elements and Mapping. Individual data elements, data types, field lengths, field description/code assignments, and mapping locators (UB-04, HCFA 1500, ANSI X12N 270/271, 835, 837) for each file shall be as detailed in the following appendices:

(a)

(1)

Member Eligibility File Specifications – Appendix C-1

 

(2)

Member Eligibility File Mapping to National Standard Formats – Appendix C-2

(b)

(1)

Medical Claims File Specifications – Appendix D-1

 

(2)

Medical Claims File Mapping to National Standard Formats – Appendix D-2

(c)

(1)

Pharmacy Claims File Specifications – Appendix E-1

 

(2)

Pharmacy Claims File Mapping to National Standard Formats – Appendix E-2

Section 6: Submission Requirements

Data submission requirements shall be as detailed in the attached appendices.

A. Registration Form. It is the responsibility of each Health Insurer to resubmit or amend the registration form required by Section 4 (A) whenever modifications occur relative to the data files or contact information.

B. File Organization. The member eligibility file, medical claims file and pharmacy claims file shall be submitted to BISHCA or its designee as separate ASCII files.

Each record shall terminate with a carriage return (ASCII 13) or a carriage return line feed (ASCII 13, ASCII 10).

C. Filing Media. Files shall be submitted utilizing one of the following media: diskette (1.44 MB), CD-ROM (650 MB), DVD, secure SSL web upload interface, or electronic transmission through a File Transfer Protocol. E-mail attachments shall not be accepted. Space permitting, multiple data files may be submitted utilizing the same media if the external label identifies the multiple files.

D. Transmittal Sheet. All file submissions on physical media shall be accompanied by a hard copy transmittal sheet containing the following information: identification of the Reporter, file name, type of file, data period(s), date sent, record count(s) for the file(s), and a contact person with telephone number and E- mail address. The information on the transmittal sheet shall match the information on the header and trailer records. See Appendix I.

E. Testing of Files. At least sixty days prior to the initial submission of the files or whenever the data element content of the files as described in Section 5 is subsequently altered, each Reporter shall submit to BISHCA or its designee a data set for comparison to the standards listed in Section 7. The size, based upon a calendar period of one month, quarter, or year, of the data files submitted shall correspond to the filing period established for each Reporter under subsection I of this Section.

F. Rejection of Files. Failure to conform to subsections A, B, or C of this Section shall result in the rejection and return of the applicable data file(s). All rejected and returned files shall be resubmitted in the appropriate, corrected form to BISHCA or its designee within 10 days.

G. Replacement of Data Files. No Reporter may replace a complete data file submission more than one year after the end of the month in which the file was submitted unless it can establish exceptional circumstances for the replacement. Any replacements after this period must be approved by BISHCA. Individual adjustment records may be submitted with any monthly data file submission.

H. Run-Out Period. Reporters shall submit medical and pharmacy claims files for at least a six month period following the termination of coverage date for all members who are Vermont residents or non-residents receiving covered services provided by Vermont health care providers or facilities.

I. Data Submission Schedule. The reporting period for submission of each specified file listed in Section 5 shall be determined on a separate basis for Vermont members and non-resident members by the highest total number of Vermont resident members or non-resident members receiving covered services provided by Vermont providers or facilities for which claims are being paid for any one month of the calendar year. Data files are to be submitted in accordance with the following schedule:


Total # of Members

Reporting Period

Reporting Schedule

≥ 2,000

Monthly

Prior to the end of the month

following the month in which claims were paid

500 – 1,999

Quarterly

Prior to April 30, July 31,

October 31, January 31 for each preceding calendar quarter in which claims were paid

200 - 499

Annually

Prior to April 30 of the

following year for the preceding twelve months in which claims were paid

< 200

N/A

 

If the data files submitted by an individual Reporter support or are related to the files submitted by another Reporter, BISHCA shall establish a filing period for the parties involved.

Section 7: Compliance with Data Standards

A. Standards. BISHCA or its designee shall evaluate each member eligibility file, medical claims file and pharmacy claims file in accordance with the following standards:

(1) The applicable code for each data element shall be as identified in Appendices C-1, D-1, and E-1 and shall be included within eligible values for the element;

(2) Coding values indicating “data not available”, “data unknown”, or the equivalent shall not be used for individual data elements unless specified as an eligible value for the element;

(3) Member sex, diagnosis and procedure codes, and date of birth and all other date fields shall be consistent within an individual record;

(4) Member identifiers shall be consistent across files; and

(5) Files submitted shall not contain direct personal identifiers.

B. Notification. Upon completion of this evaluation, BISHCA or its designee will promptly notify each Reporter whose data submissions do not satisfy the standards for any reporting period. This notification will identify the specific file and the data elements that are determined to be unsatisfactory.

C. Response. Each Reporter notified under subsection 7.B shall resubmit within 60 days of the date of notification with the required changes.

D. Compliance. Failure to file, report, or correct health care claims data sets in accordance with the provisions of this regulation may be considered a violation of 18 V.S.A. § 9410 (g).

Section 8: Procedures for the Approval and Release of Claims Data

The requirements, procedures and conditions under which persons other than the Department may have access to health care claims data sets and related information received or generated by the Department or its designee pursuant to this regulation shall depend upon the requestor and the characteristics of the particular information requested, all as set forth below.

A. Classification of Data Elements

(1) Unrestricted Data Elements: Data elements designated in Appendix J as “Unrestricted” shall be available for general use and public release as part of a Public Use File.

(2) Restricted Data Elements: Data elements designated in Appendix J as “Restricted” shall not be available for use and release outside the Department except as part of a Limited Use Research Health Care Claims Data Set approved by the commissioner pursuant to the requirements of this regulation.

(3) Unavailable Data Elements: Data elements which are not designated in Appendix J as either Unrestricted or Restricted, or are designated as “Unavailable”, shall not be available for release or use outside the Department in any data set or disclosed in publicly released reports in any circumstance.

B. Public Use Data Sets: Release and Availability

(1) Unrestricted Data Elements collected or generated by the Department or its designee shall be made available in public use files and provided to any person upon written request, except where otherwise prohibited by law.

(2) The Department shall maintain a public record of all requests for and releases of public use data sets.

C. Limited Use Health Care Claims Research Data Sets- Release and Availability

(1) Limited Use Health Care Claims Research Data Sets shall be those sets which contain restricted data elements, shall not be available to the general public and shall be released to a requestor only for the purpose of research upon a determination by the Commissioner that the following conditions have been met:

(a) Application: Any person requesting access to or use of Limited Use Health Care Claims Research Data Sets shall submit an application, in written and electronic form, to the Commissioner disclosing the information listed below. Studies utilizing data sets for longer than 2 years may be required to reapply.

(1) Identity of principal investigator:

(a) Name, address, and phone number;

(b) Organizational affiliation;

(c) Professional qualification; and

(d) Phone number of principal investigator's contact person, if any.

(2) Identity of person requesting access, including any entities for whom that person is acting in requesting the data.

(a) Name, address, and phone number;

(b) Organizational affiliation;

(c) Professional qualification; and

(d) Name and phone number of contact person.

(3) Identity of and qualifications of any other persons who may have access to the data.

(4) A detailed research protocol, to include:

(a) A summary of background, purposes, and origin of the research;

(b) A statement of the health-related problem or issue to be addressed by the research;

(c) The research design and methodology, including either the topics of exploratory research or the specific research hypotheses to be tested;

(d) The procedures that will be followed to maintain the confidentiality of any data or copies of records provided to the principal investigator or other persons; and

(e) The intended research completion date;

(5) Particular data set requested, including:

(a) The time period of the data requested;

(b) The specific data elements or fields of information required;

(c) A justification of the need for each restricted element or field, as identified in the data release schedule;

(d) The minimum needed specificity of the requested data elements, including the manner in which the data may be recoded by the department to be less specific;

(e) The selection criteria for the minimum needed data records required; and

(f) Any particular format or layout of data requested by the principal investigator.

(6) Any changes to information submitted as part of an application pursuant to (a)(1)-(4) shall require notice to the Department by the applicant and shall be subject to the approval of the Commissioner.

(b) The person or entity requesting access and the principal investigator or investigators shall be subject to the following requirements and limitations and shall, in addition, sign and submit a data use agreement acknowledging and accepting these same provisions as a necessary condition to any data access:

(1) Use of data for any purpose other than as specified in the application and approved by the Commissioner shall be prohibited;

(2) Appropriate safeguards to protect the confidentiality of the data and prevent unauthorized use of the data shall be established;

(3) The use or disclosure, sale, or dissemination of the data set or statistical tabulations derived from the data set to any person or organization for any purpose other than as described in the application and as permitted by the data use agreement shall be prohibited without the express written consent of the Commissioner.

(4) The use or disclosure, sale, or dissemination of any information contrary to law shall be prohibited;

(5) No person shall disclose the identity of patients, employer groups or purchaser groups from information contained in the limited use data set;

(6) No person shall disclose any of the information that has been encrypted or removed from the data;

(7) The content of cells that contain counts of persons in statistical tables in which the cell size is more than 0 and less than 5 shall not be disclosed, published or made public in any manner except as “<5”;

(8) The publication, dissemination or disclosure of any information that could be used to identify providers of abortion services shall be prohibited;

(9) Any use or disclosure of the information that is contrary to the Data Use Agreement or this Regulation shall be reported to the Department within five (5) days of when the principal investigator becomes aware of such disclosure.

(10) The Department and the “Vermont Healthcare Claims Uniform Reporting and Evaluation System” shall be acknowledged as the source and owner of the data in any and all public reports, publications, or presentations generated from the data;

(11) Written materials shall prominently state that the analyses, conclusions and recommendations drawn from such data are solely those of the requestor or principal investigator and are not necessarily those of the Department;

(12) The Department shall be provided with a copy of any proposed report or publication containing information derived from the data at least 15 days prior to any publication or release to allow the department to review the proposed report or publication and confirm that the conditions of the agreement have been applied. When multiple reports of a similar nature will be created from the data, the Department may, on request, waive the requirement that any subsequent reports or publications be provided to the Department prior to release by the requesting party

(13) Data elements shall not be retained for any period of time beyond that necessary to fulfill the requirements of the data request.

(14) Within 30 days after the scheduled completion date of the project, the requestor shall delete, destroy or otherwise render the data unreadable, so certifying by submitting a written notice to the Department or by reapplying for approval if the end date of the project needs to be extended;

(15) Any draft reports or publications supplied to the department shall be considered confidential and exempt from public review under 1 V.S.A. §315 et seq. and shall not be released by the Department; and

(16) Failure to adhere to the data use agreement or the limitations and restrictions detailed above will be cause for immediate recall by the Department of the data, revocation of permission to use the data, and grounds for civil or administrative enforcement action by the Department under applicable Vermont state law.

(c) The Department shall establish a claims data release advisory committee with a chair person and members appointed annually by the Commissioner, to provide non-binding advice and opinion to the Commissioner, as and when requested, on the merits of applications for access to limited use data sets. If the Commissioner has requested a review of the application, the claims data release advisory committee shall provide the Commissioner with any comment on the merits of the application and the research protocol described therein within thirty (30) days. The committee shall be comprised of seven (7) members and include:

(1) At least one member representing health insurers;

(2) At least one member representing health care facilities;

(3) At least one member representing health care providers;

(4) At least one member representing purchasers of health insurance or health benefits; and

(5) At least one member representing healthcare researchers.

(2) The Commissioner may approve the release of limited use data sets only when the Commissioner is satisfied as to the following:

(a) The application submitted is complete and the requesting individuals or entities and principal investigator have signed a data use agreement as specified;

(b) Procedures to ensure the confidentiality of any patient and any confidential data are documented;

(c) The qualifications of the investigator and research staff, as evidenced by:

(1) Training and previous research, including prior publications; and

(2) An affiliation with a university, private research organization, medical center, state agency, or other qualified institutional entity.

(d) No other state or federal law or regulation prohibits release of the requested information.

(3) If the Commissioner declines to release the requested limited use data sets within 60 days of receipt of a complete application, the Department shall give written notice of the basis for denial of the application and the requestor shall have leave to resubmit or supplement the application to address the Commissioner’s concerns. Any adverse decision regarding an application may be appealed within 30 days by filing a request for hearing with the Commissioner pursuant to Department Rule 82-1.

Section 9: Prices for Data Sets, Fees for Programming and Report Generation, Duplication Rates

This Section lists the prices for data sets from the Vermont Healthcare Claims Uniform Reporting and Evaluation System, including the fees for programming and report generation, duplicating charges and other costs associated with the production and transmission of data sets approved for release by the Department.

A. An annual public use file consisting of unrestricted fields and data elements shall be made available to any person upon request at the cost required for the Department to process, package and ship the data set, including any electronic medium used to store the data.

B. Limited Use Research Health Care Claims Data Sets approved by the Department shall be made available to the requesting party at the cost charged by the Department’s designated vendor to program and process the requested data extract, including any consulting services and costs to package and ship the data set on particular electronic medium.

C. Payments are due in full from the requesting party within thirty days of receipt of BISHCA data sets, files, reports, or other released material.

Section 10: Enforcement

Violations of data submission requirements, confidentiality requirements, data use limitations or any other provisions of this rule shall be subject to sanction by the Commissioner as set out in 18 V.S.A. §9410 in addition to any other powers granted to the Commissioner to investigate, subpoena, fine or seek other legal or equitable remedies.

Section 11: Severability

If any provision of this regulation or the application thereof to any person or circumstance is for any reason held to be invalid, the remainder of the regulation and the application of such provisions to other persons or circumstances shall be not affected thereby.

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