Certification of Independent Review Organizations

November 9, 2012

Bulletin 193

CERTIFICATION OF INDEPENDENT REVIEW ORGANIZATIONS

This Bulletin is directed to all insurers, as defined by IC 27-8-28-9, and all health

maintenance organizations (HMOs) doing business in Indiana, and to all organizations acting as

or interested in acting as independent review organizations (IROs) for the external grievance

procedures set forth in IC 27-13-10.1 or IC 27-8-29 (collectively, the "IRO laws"). For the

purposes of this Bulletin, the term "insurer" refers to both HMOs and insurers. In the event of a

material difference between the articles pertaining to HMOs and insurers, IC 27-13-10.1 applies

to HMOs and IC 27-8-29 applies to insurers.

Indiana requires each insurer doing business in Indiana to establish and maintain an

external review grievance procedure. The Department is required to establish and maintain a

process for annual certification ofIROs and to maintain a list of certified IROs to be used by

insurers. The federal Patient Protection and Affordable Care Act (Publ. Law 111-I 48) and the

Health Care and Education Reconciliation Act (Publ. Law 111-152) (collectively "ACA")

directed the federal Department ofHealth and Human Services (HHS) to promulgate regulations

implementing ACA's provisions. Among those regulations were ones relating to IROs. This

Bulletin sets forth the procedure for certification, including compliance with requirements

promulgated under ACA, and updates and replaces Bulletin 188.

The IRO laws routinely use the te1m "external grievance," while ACA and HHS

regulations use the term "external review." For purposes of this Bulletin, the terms "external

grievance" and "external review" have the same meaning.

Request for Certification as an IRO

To be considered for certification, organizations must submit a Request for Certification

(Request) to the Department, per instructions found on the Department's web site:

www.in.gov/idoi. The Request must comply with all instructions contained in this Bulletin

ses of this Bulletin, the terms "external

grievance" and "external review" have the same meaning.

Request for Certification as an IRO

To be considered for certification, organizations must submit a Request for Certification

(Request) to the Department, per instructions found on the Department's web site:

www.in.gov/idoi. The Request must comply with all instructions contained in this Bulletin.

Incomplete Requests will not be considered. A Request must include the following information:

•

Identifiable and specific responses to each criteria set forth in this Bulletin and the

IRO laws;

•

A statement certifying that all information included in the Request is accurate to the

best of the Applicant's knowledge and belief and signed by the Applicant's chief

executive officer or an individual authorized to act in similar capacity for the

Applicant;

•

Consecutive page numbering and identification of sections.

•

Written proof that the IRO is "accredited by a private, nationally recognized

accrediting organization." This proof shall be submitted as an addendum to the

request. The addendum must include a copy ofthe formal document showing

accreditation and must be appropriately titled.

Section 1 - Technical/Procedure

This section must describe the organization's approach and plans for accomplishing the

external grievance review process described in the IRO Laws. The organization should describe

the effort and skills necessary to complete the process. This section shall contain at least the

following infmmation:

1) A summary ofthe organization's case review process, which demonstrates an

understanding ofthe law governing the external review process.

2) A description ofhow the work will be accomplished within each step ofthe case

review process. Simple statements that a task will be completed or a reiteration ofthe

criteria are not acceptable

s section shall contain at least the

following infmmation:

1) A summary ofthe organization's case review process, which demonstrates an

understanding ofthe law governing the external review process.

2) A description ofhow the work will be accomplished within each step ofthe case

review process. Simple statements that a task will be completed or a reiteration ofthe

criteria are not acceptable. The description should explain the process to be employed in

reviewing an insurer's determination and include a flow chart depicting the process by

which external review will proceed from the receipt ofthe Request for review to the final

decision. The explanation should address the criteria used in the decision-making

process and the systems and methods used to process case reviews, including the

following:

a) Process for providing a decision in the statutorily mandated amount oftime.

b) Process for selecting and assigning reviewers to cases including the recruitment

and contracting, credentialing, and assignment of appropriate specialists to cases.

c) Process for ensuring independence, including any contract provisions with

reviewers that require the contracted reviewer to review the case for potential

conflicts ofinterest before accepting the assignment.

d) Process for maintaining the confidentiality ofmedical and treatment records and

any other review materials dnring communication with parties involved in the review

process and during "in house" communication.

e) Process for communication with parties involved in the review process, including

any requirements for the process that insnrers must follow when submitting the

Request for external review and the case file.

f) Process for requesting and receiving additional information from insurers or other

parties, including any requirements that responses be submitted by a paiiicular

method (i.e

ation.

e) Process for communication with parties involved in the review process, including

any requirements for the process that insnrers must follow when submitting the

Request for external review and the case file.

f) Process for requesting and receiving additional information from insurers or other

parties, including any requirements that responses be submitted by a paiiicular

method (i.e. overnight mail, facsimile), and whether the organization will re-contact

an insurer if information is not provided in a timely fashion and the process for doing

so.

g) Process for rendering and communicating decisions.

h) Process for maintaining written records pertaining to each case review and the

retention schedule ofthose records.

3) A summary of any problems the organization might reasonably expect in the external

review process, and anticipated solutions to those problems.

4) A drafted format for the annual repo1i to the Depaiiment required by IC 27-13-10.1­

8(c)(3) and/or IC 27-8-29-19(c)(3).

5) A description ofthe statistics maintained by the IRO that will be made available to

the Depaiiment on request.

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Section 2 - Cost

This section must contain all information related to fees to be charged by the IRO to the

HMO or insurer.

1) Fees charged for each review should be reasonable in relation to the work performed.

Work performed should be broken down into the following review types:

a) Preliminary review;

b) Situations where full review is not necessary owing to reversal by the insurer of

its adverse dete1mination due to new information; and

c) Full review.

2) Ifthe fee structure is other than a flat, per case rate, the basis upon which it will be

determined, including the anticipated average cost per case.

3) A statement that all fee schedules submitted with the Request will not be increased

during the one-year certification period

cessary owing to reversal by the insurer of

its adverse dete1mination due to new information; and

c) Full review.

2) Ifthe fee structure is other than a flat, per case rate, the basis upon which it will be

determined, including the anticipated average cost per case.

3) A statement that all fee schedules submitted with the Request will not be increased

during the one-year certification period.

Section 3 - Organizational Support and Experience

This section must contain all pe1iinent information relating to the organization's

personnel and experience that would substantiate its qualifications and capabilities to perform

external reviews as described in the IRO laws. This section must contain at least the following

inf01mation:

1) Certification of incorporation or partnership and location of.Applicant's headquarters

and offices in or nearest to Indiana.

2) Any organization requesting ce1iification as an IRO must provide the following

information about the organization and any parent corporation, subsidiary, or affiliate:

a) Name and address of each member ofthe board ofdirectors;

b) Name and address of any owner, partner or any other person with 10% or more

voting shares;

3) A chart illustrating the relationship among all affiliated entities.

4) An internal organizational cha1i that identifies key grievance review staff members

and their responsibilities within the organization; provides an estimate ofthe number,

types, and functions ofthe personnel considered necessary to the administration and

operation ofthe organization in Indiana with a separate job description detailing the roles

ofkey persons; and describes the contractual and financial relationships between the

organization and the clinical personnel who will be responsible for individual case

reviews.

5) A list of personnel who may be assigned to individual case reviews

ersonnel considered necessary to the administration and

operation ofthe organization in Indiana with a separate job description detailing the roles

ofkey persons; and describes the contractual and financial relationships between the

organization and the clinical personnel who will be responsible for individual case

reviews.

5) A list of personnel who may be assigned to individual case reviews. For each

reviewer, the list must include the name, professional license( s ), board ce1iification( s ),

and any history ofdisciplinary actions or sanctions that raise a substantial question as to

the reviewer's physical, mental or professional competence or moral character, including

loss ofstaff privileges, or restrictions on participation, taken or pending by any hospital,

government or regulatory body.

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6) A list of all managed care organizations, hospitals, health care facilities, and other

health care providers with whom the organization maintains any health related business

arrangements. This list must include a brief description ofthe nature of any such

anangement.

7) A description ofhow the organization will:

a) Provide licensed review personnel who possess the appropriate training and

qualifications in the medical subject area for which they will be conducting the

review, including the criteria to be used for the selection or rejection of review

personnel.

b) Ensure the availability of appropriate personnel as needed for timely and efficient

review.

c) Ensure the neutrality and objectivity of all personnel conducting external reviews,

including avoidance of conflicts of interest or the appearance of a conflict ofinterest.

8) A description ofthe organization's quality assurance program for case review.

9) Documentation which clearly shows the organization's experience in performing

similar reviews and describes the organization's experience in utilization review,

including an explanation oflevel(s) and scope ofinvolvement in the utilization review

process

of interest or the appearance of a conflict ofinterest.

8) A description ofthe organization's quality assurance program for case review.

9) Documentation which clearly shows the organization's experience in performing

similar reviews and describes the organization's experience in utilization review,

including an explanation oflevel(s) and scope ofinvolvement in the utilization review

process. The organization may also provide a list of references, including entities for

which the Applicant has performed similar review under any state or federal external

grievance review law.

10) A statement that the organization agrees to accept all eligible cases refened to it on

the rotating basis required to be used by insurers.

11) A statement that the organization accepts the following procedure. 45 CFR

147.136(c)(2)(vii) requires that the State process must provide that IROs will be assigned

on a random basis or another method of assignment that assures the independence and

impartiality ofthe assignment process (such as rotational assignment) by a State or

independent entity, and in no event selected by the issuer, plan, or the individual.

Therefore, the Department will maintain an approved list ofcertified IROs to be used by

insurers. Assignments ofIROs for eligible cases will be made by the Department

sequentially from the approved list, and no insurer will be assigned the same IRO until

they have completed the whole list. The list will be regularly updated and posted at

www.in.gov/idoi. Insurers may click the "Sign up to receive e-mail and wireless updates

from the IDOI" link on the Department's web site to receive automatic updates to the list.

12) A statement that the Request designates agreement to comply with the IRO laws.

13) A list of all professional designations and/or licenses held by the organization and a

brief explanation ofall credentials held by the organization from other states and

credentialing organizations

nd wireless updates

from the IDOI" link on the Department's web site to receive automatic updates to the list.

12) A statement that the Request designates agreement to comply with the IRO laws.

13) A list of all professional designations and/or licenses held by the organization and a

brief explanation ofall credentials held by the organization from other states and

credentialing organizations.

14) A description of any disciplinary actions or sanctions taken or ongoing against the

organization in the preceding ten (10) years.

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Section 4 - Right to Submit Additional Information

This section must contain the organization's approach and plans for complying with a

covered individual's right to submit additional info1mation to the IRO and must provide detailed

descriptions ofhow the IRO intends to comply with the following:

1) The covered individual must be notified via telephone, email, or in printed writing, by

the IRO perfmming the external review, ofthe individual's right to submit additional

info1mation.

a) The cost ofnotification may not be charged to the covered individual;

b) Notification ofthe right to submit additional information must occm promptly

after the individual has filed a request for external review with the IRO;

c) The language ofthe notification must be concise and clear; and

d) The notification may be included as a section ofroutine correspondence, provided

that it remains distinguished from other conespondence.

2) The covered individual must be provided at least five business days to submit any

additional information, provided that this requirement does not otherwise:

a) Prolong the time required to resolve an expedited external review; or

b) Conflict with other provisions ofthe IRO laws.

3) Any additional information submitted by the covered individual must be forwarded to

the insurer within one business day ofreceipt by the IRO

be provided at least five business days to submit any

additional information, provided that this requirement does not otherwise:

a) Prolong the time required to resolve an expedited external review; or

b) Conflict with other provisions ofthe IRO laws.

3) Any additional information submitted by the covered individual must be forwarded to

the insurer within one business day ofreceipt by the IRO.

Department Review

The Department may:

• Approve any number of entities for certification as IROs;

• Reject any request for certification or re-certification if determined by the Commissioner to

be necessary, appropriate, or in the best interests of insurers and their emollees;

• Suspend, revoke or otherwise sanction an organization's IRO certification ifthe

Commissioner dete1mines that the organization is not in substantial compliance with the

info1mation provided in the organization's Request, any applicable law, or any regulation or

other guidance issued by the Commissioner;

• Request that an organization alter its activities to be consistent with any applicable law or

any regulation or other guidance issued by the Commissioner; or

• Deny or reassign a request for external review ifthe Commissioner has reason to believe that

such an assignment would result in or create the appearance of a conflict ofinterest or ifthe

Commissioner determines that the organization cannot or has not conducted a review in

accordance with the statute.

Timelines

The period of certification is one year. The IRO Ce1tification List shall be published on

the Depmtment website: http://www.in.gov/idoi.

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IRO certification and/or re-certification is performed on an annual basis. Requests for

certification or re-certification must be delivered to the Department on or before December 1 of

each year.

Submission of Request

Requests should be submitted electronically to Rebecca Vaughan at rvaughan@idoi.INgov, in

Microsoft Word or PDF format.

Step en W. obetison,

Insurance Commissioner

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