WACs relating to assignments of independent review organizations (IRO)
(Effective July 1, 2001)
WAC 284-43-615 Grievance and complaint procedures — Generally
- Each carrier must adopt and implement a comprehensive process for the resolution of covered persons' grievances and appeals of adverse determinations. This process shall meet accepted national certification standards such as those used by the National Committee for Quality Assurance except as otherwise required by this chapter.
- This process must conform to the provisions of this chapter and each carrier must:
- Provide a clear explanation of the grievance process upon request, upon enrollment to new covered persons, and annually to covered person and subcontractors of the carrier.
- Ensure that the grievance process is accessible to enrollees who are limited-English speakers, who have literacy problems, or who have physical or mental disabilities that impede their ability to file a grievance.
- Process as a grievance a covered person's expression of dissatisfaction about customer service or the quality or availability of a health service.
- Implement procedures for registering and responding to oral and written grievances in a timely and thorough manner including the notification of a covered person that a grievance or appeal has been received.
- Assist the covered person with all grievance and appeal processes.
- Cooperate with any representative authorized in writing by the covered person.
- Consider all information submitted by the covered person or representative.
- Investigate and resolve all grievances and appeals.
- Provide information on the covered person's right to obtain second opinions.
- Track each appeal until final resolution; maintain, and make accessible to the commissioner for a period of three years, a log of all appeals; and identify and evaluate trends in appeals.
[Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.100, 48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-615, filed 1/9/01, effective 7/1/01.]
(Effective July 1, 2001)
WAC 284-43-620 Procedures for review and appeal of adverse determinations
- A covered person or the covered person's representative, including the treating provider (regardless of whether the provider is affiliated with the carrier) acting on behalf of the covered person may appeal an adverse determination in writing. The carrier must reconsider the adverse determination and notify the covered person of its decision within fourteen days of receipt of the appeal unless the carrier notifies the covered person that an extension is necessary to complete the appeal; however, the extension cannot delay the decision beyond thirty days of the request for appeal, without the informed, written consent of the coverage person.
- Whenever a health carrier makes an adverse determination and delay would jeopardize the covered person's life or materially jeopardize the covered person's health, the carrier shall expedite and process either a written or an oral appeal and issue a decision no later than seventy-two hours after receipt of the appeal. If the treating health care provider determines that delay could jeopardize the covered person's health or ability to regain maximum function, the carrier shall presume the need for expeditious review, including the need for an expeditious determination in any independent review under WAC 284-43-630.
- A carrier may not take or threaten to take any punitive action against a provider acting on behalf or in support of a covered person appealing an adverse determination.
- Appeals of adverse determinations shall be evaluated by health care providers who were not involved in the initial decision and who have appropriate expertise in the field of medicine that encompasses the covered person's condition or disease.
- All appeals must include a review of all relevant information submitted by the covered person or a provider acting on behalf of the covered person.
- The carrier shall issue to affected parties and to any provider acting on behalf of the covered person a written notification of the adverse determination that includes the actual reasons for the determination, the instructions for obtaining an appeal of the carrier's decision, a written statement of the clinical rationale for the decision, and instructions for obtaining the clinical review criteria used to make the determination.
[Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.100, 48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-620, filed 1/9/01, effective 7/1/01. Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.43.055, 48.44.050, 48.46.100 and 48.46.200. 99-24-075 (Matter No. R 98-17), § 284-43-620, filed 11/29/99, effective 12/30/99.]
(Effective July 1, 2001)
WAC 284-43-630 Independent review of adverse determinations
- A covered person may seek review by a certified independent review organization of an adverse decision after exhausting the carrier's grievance process and receiving a decision that is unfavorable to the covered person, or after the carrier has exceeded the timelines for grievances provided in this chapter, without good cause and without reaching a decision. Upon prior written approval of the carrier's process by the commissioner, a carrier may establish a process to bypass the carrier's internal grievance process and allow for the direct appeal to a certified independent review organization for certain classes of adverse determinations.
- Carriers must provide to the appropriate independent review organization certified by the department of health and designated by the commissioner's rotational registry, not later than the third business day after the date the carrier receives a request for review, a copy of:
- Any medical records of the covered person that are relevant to the review;
- Any documents used by the carrier in making the determination to be reviewed by the certified independent review organization; including relevant clinical review criteria used by the carrier and other relevant medical, scientific, and cost-effectiveness evidence;
- Any documentation and written information submitted to the carrier in support of the appeal;
- A list of each physician or health care provider who has provided care to the covered person and who may have medical records relevant to the appeal. Health information or other confidential or proprietary information in the custody of a carrier may be provided to an independent review organization, subject to the privacy provisions of Title 284 WAC;
- The attending or ordering provider's recommendations; and
- The terms and conditions of coverage under the relevant health plan. The carrier shall also make available to the covered person and to any provider acting on behalf of the covered person all materials provided to an independent review organization reviewing the carrier's determination. The carrier may also require the covered person and any provider acting on behalf of a covered person to make available to the carrier information provided to an independent review organization in support of an appeal.
- The medical reviewers from a certified independent review organization shall make determinations regarding the medical necessity or appropriateness of, and the application of health plan coverage provisions to, health care services for a covered person. The medical reviewers' determinations must be based upon their expert medical judgment, after consideration of relevant medical, scientific, and cost-effectiveness evidence, and medical standards of practice in the state of Washington. Except as provided in this subsection, the certified independent review organization must ensure that determinations are consistent with the scope of covered benefits as outlined in the medical coverage agreement. Medical reviewers may override the health plan's medical necessity or appropriateness standards if the standards are determined upon review to be unreasonable or inconsistent with sound, evidence-based medical practice.
- Once a request for an independent review determination has been made, the independent review organization must proceed to a final determination, unless requested otherwise by both the carrier and the covered person or covered person's representative.
- Carriers must implement the certified independent review organization's determination promptly, and must pay the certified independent review organization's charges.
[Statutory Authority: RCW 48.02.060,48.18.120, 48.20.450, 48.20.460, 48.30.010,48.44.050, 48.46.100,48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-630, filed 1/9/01, effective 7/1/01.]
WAC 246-305-001 Purpose and scope
- Purpose. These rules are adopted by the Washington state department of health to implement the provisions of RCW 43.70.235 regarding the certification of independent review organizations. Certified independent review organizations are qualified to receive referrals from the insurance commissioner under RCW 48.43.535 to make binding determinations related to health care coverage and payment disputes between health insurance carriers and their enrollees.
- Other applicable rules. Independent review also is subject to rules of the insurance commissioner implementing RCW 48.43.535.
- Applicability. These rules apply to independent review cases originating in Washington state under RCW 48.43.535, and to independent review organizations conducting these reviews.
WAC 246-305-010 Definitions
For the purpose of this chapter, the following words and phrases shall have the following meanings unless the context clearly indicates otherwise.
- "Adverse determination" means a decision by a health carrier to deny, modify, reduce, or terminate coverage of or payment for a health care service for an enrollee.
- "Applicant" means a person or entity seeking to become a Washington certified IRO (independent review organization).
- "Attending provider" includes "treating provider" or "ordering provider" as used in WAC 284-43-620 and 284-43-630.
- "Carrier" or "health carrier" has the same meaning in this chapter as in WAC 284-43-130.
- "Case" means a dispute relating to a carrier's decision to deny, modify, reduce, or terminate coverage of or payment for health care service for an enrollee, which has been referred to a specific IRO by the insurance commissioner under RCW 48.43.535 .
- "Clinical peer" means a physician or other health professional who holds an unrestricted license or certification and is in the same or similar specialty as typically manages the medical condition, procedures, or treatment under review. Generally, as a peer in a similar specialty, the individual must be in the same profession, i.e., the same licensure category, as the attending provider. In a profession that has organized, board-certified specialties, a clinical peer generally will be in the same formal specialty.
- "Clinical reviewer" means a medical reviewer, as defined in this section.
- "Conflict of interest" means violation of any provision of WAC 246-305-030, including, but not limited to, material familial, professional and financial affiliations.
- "Contract specialist" means a reviewer who deals with interpretation of health plan coverage provisions. If a clinical reviewer is also interpreting health plan coverage provisions, that reviewer must have the qualifications required of a contract specialist.
- "Department" means the Washington department of health.
- "Enrollee" means a "covered person" as defined in WAC 284-43-130. "Enrollee" also means a person lawfully acting on behalf of the enrollee, including, but not limited to, a parent or guardian.
- "Health care provider" or "provider" means a person practicing health care services consistent with Washington state law, or a person with valid credentials from another state for a similar scope of practice.
- "Independent review" means the process of review and determination of a case referred to an IRO under RCW 48.43.535 .
- "Independent review organization" or "IRO" means an entity certified by the department under this chapter.
- "IRO," see independent review organization.
- "Material familial affiliation" means any relationship as a spouse, child, parent, sibling, spouse's parent, or child's spouse.
- "Material professional affiliation" includes, but is not limited to, any provider-patient relationship, any partnership or employment relationship, or a shareholder or similar ownership interest in a professional corporation.
- "Material financial affiliation" means any financial interest including employment, contract or consultation which generates more than five percent of total annual revenue or total annual income of an IRO or an individual director, officer, executive or reviewer of the IRO. This includes a consulting relationship with a manufacturer regarding technology or research support for a specific product.
- "Medical reviewer" means a physician or other health care provider who is assigned to an external review case by a certified IRO, consistent with this chapter.
- "Medical, scientific, and cost-effectiveness evidence" means published evidence on results of clinical practice of any health profession which complies with one or more of the following requirements:
- Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;
- Peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institute of Health's National Library of Medicine for indexing in Index Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS data base Health Services Technology Assessment Research (HSTAR);
- Medical journals recognized by the Secretary of Health and Human Services, under Section 1861 (t)(2) of the Social Security Act;
- The American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluation, the American Dental Association Accepted Dental Therapeutics, and the United States Pharmacopoeia-Drug Information;
- Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes including the Federal Agency for Healthcare Research and Quality, National Institutes of Health, National Cancer Institute, National Academy of Sciences, Health Care Financing Administration, Congressional Office of Technology Assessment, and any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health services;
- Clinical practice guidelines that meet institute of medicine criteria; or
- In conjunction with other evidence, peer-reviewed abstracts accepted for presentation at major scientific or clinical meetings.
- "Referral" means receipt by an IRO of notification from the insurance commissioner that a case has been assigned to that IRO under provisions of RCW 48.43.535 .
- "Reviewer" or "expert reviewer" means a clinical reviewer or a contract specialist, as defined in this section.
WAC 246-305-020 General requirements for certification
In order to qualify for certification, an IRO must:
- Demonstrate expertise and a history of reviewing health care in terms of medical necessity, appropriateness, and the application of other health plan coverage provisions.
- Demonstrate the ability to handle a full range of review cases occurring in Washington. Certified IROs may contract with more specialized review organizations; however, the certified IRO must ensure that each review conducted meets all the requirements of this chapter.
- Demonstrate capability to review administrative and contractual coverage issues, as well as medical necessity and effectiveness and the appropriateness of experimental and investigational treatments.
- Comply with all conflict of interest provisions in WAC 246-305-030.
- Maintain and assign qualified expert reviewers in compliance with WAC 246-305-040.
- Conduct reviews, reach determinations and document determinations consistent with WAC 246-305-050 and 246-305-060.
- Maintain administrative processes and capabilities in compliance with WAC 246-305-070.
- File an application for certification meeting the requirements of WAC 246-305-080.
WAC 246-305-040 Expert reviewers
- Each IRO must maintain an adequate number and range of qualified expert reviewers in order to:
- All reviewers shall be health care providers with the exception of contract specialists.
- IROs must maintain policies and practices that assure that all clinical reviewers:
- Hold a current, unrestricted license, certification, or registration in Washington, or current, unrestricted credentials from another state with substantially comparable requirements, as determined by the department and outlined in the November 2000 edition of the department of health publication, Health Care Professional Credentialing Requirements;
- Have at least five years of recent clinical experience;
- Are board-certified in the case of a medical doctor, a doctor of osteopathy, a podiatrist, or a member of another profession in which board certification exists as determined by the department of health; and
- Have the ability to apply scientific standards of evidence in judging research literature pertinent to review issues, as demonstrated through relevant training or professional experience.
- Contract specialists must be knowledgeable in health insurance contract law, as evidenced by training and experience, but do not need to be an attorney or have any state credential.
- Assignment of appropriate reviewers to a case.
- An IRO shall assign one or more expert reviewer to each case, as necessary to meet requirements of this subsection.
- Any reviewer assigned to a case must comply with the conflict of interest provisions inWAC 246-305-030.
- The IRO shall assign one or more clinical reviewers to each case. At least one clinical reviewer assigned to each case must meet each of the following requirements:
- Have expertise to address each of the issues that are the source of the dispute;
- Be a clinical peer as defined in WAC 246-305-010(6);
- Have the ability to evaluate alternatives to the proposed treatment.
- All clinical reviewers assigned must have at least five years of recent clinical experience dealing with the same health conditions under review or similar conditions. Exceptions may be made to this requirement in unusual situations when the only experts available for a highly specialized review are in academic or research life and do not meet the clinical experience requirement.
- If contract interpretation issues must be addressed, a contract specialist must be assigned to the review.
- Each IRO must have a policy specifying the number and qualifications of reviewers to be assigned to each case. The number of expert reviewers should be dictated by what it takes to meet the requirements of this subsection.
- The number of expert reviewers should reflect the complexity of the case, the goal of avoiding unnecessary cost, and the need to avoid tie votes.
- The IRO may consider, but shall not be bound by, recommendations regarding complexity from the carrier or attending provider.
- Special attention should be given to situations such as review of experimental and investigational treatments that may benefit from an expanded panel.
WAC 246-305-050 Independent review process
- Information for review.
- IROs must request as necessary, accept and consider the following information as relevant to a case referred:
- Information that the carrier is required to submit to the IRO under WAC 284-43-630, including information identified in that section that is initially missing or incomplete as submitted by the carrier.
- Other medical, scientific, and cost-effectiveness evidence which is relevant to the case. For the purposes of this section, medical, scientific, and cost-effectiveness evidence has the meaning assigned in WAC 246-305-010.
- After referral of a case, an IRO must accept additional information from the enrollee, the carrier, or a provider acting on behalf of the enrollee or at the enrollee's request, provided the information is submitted within seven calendar days of the referral or, in the case of an expedited referral, within twenty-four hours. The additional information must be related to the case and relevant to statutory criteria.
- IROs must request as necessary, accept and consider the following information as relevant to a case referred:
- Completion of reviews: Once the insurance commissioner refers a review, the IRO must proceed to final determination unless requested otherwise by both the carrier and the enrollee.
- Time frames for reviews.
- An IRO must make its determination within the following time limits:
- If the review is not expedited, within fifteen days after receiving necessary information, or within twenty days after receiving the referral, whichever is earlier. In exceptional circumstances where information is incomplete, the determination may be delayed until no later than twenty-five days after receiving the referral.
- If the review is expedited, within seventy-two hours after receiving all necessary information, or within eight days after receiving the referral, whichever is earlier. Expedited time frames apply when a condition could seriously jeopardize the enrollee's health or ability to regain maximum function, as determined consistent with WAC 284-43-620. If information on whether a referral is expedited is not provided to the IRO, the IRO may presume that it is not an expedited review, but the IRO has the option to seek clarification from the insurance commissioner.
- An IRO must provide notice to enrollees and the carrier of the result and basis for the determination, consistent with subsection (5) of this section, within two business days of making a determination in regular cases and immediately in expedited cases.
- As used in this subsection, a day is a calendar day, except that if the period ends on a weekend or an official Washington state holiday, the time limit is extended to the next business day. A business day is any day other than Saturday, Sunday or an official Washington state holiday.
- An IRO must make its determination within the following time limits:
- Decision-making procedures.
- The independent review process is intended to be neutral and independent of influence by any affected party or by state government. The department may conduct investigations under the provisions of this chapter but the department has no involvement in the disposition of specific cases.
- Independent review is a paper review process. These rules do not establish a right to in-person participation or attendance by the enrollee, the health plan, or the attending provider nor to reconsideration of IRO determinations.
- An IRO shall present cases to reviewers in a way that maximizes the likelihood of a clear, unambiguous determination. This may involve stating or restating the questions for review in a clear and precise manner that encourages yes or no answers.
- If more than one reviewer is used, the IRO shall:
- Provide an opportunity for the reviewers to exchange ideas and opinions about the case with one another, if requested by a reviewer. This shall be done in a manner that avoids pressure on reviewers to take a position with which they do not agree and preserves a dissenting reviewer's opportunity to document the rationale for dissent in the case file.
- Accept the majority decision of the clinical reviewers in determining clinical issues.
- When a case requires an interpretation regarding the application of health plan coverage provisions, that determination shall be made by a reviewer or reviewers who are qualified as contract specialists.
- An IRO may uphold an adverse determination if the patient or any provider refuses to provide relevant medical records that are available and have been requested with reasonable opportunity to respond. An IRO may overturn an adverse determination if the carrier refuses to provide relevant medical records that are available and have been requested with reasonable opportunity to respond.
- If reviewers are deadlocked, the IRO may add another reviewer if time allows.
- If all pertinent information has been disclosed and reviewers are unable to make a determination, the IRO shall decide in favor of the enrollee.
- Notification and documentation of determinations. An IRO must notify the enrollee and the carrier of the result and rationale for the determination, including its clinical basis unless the decision is wholly based on application of coverage provisions, within the time frame in subsection (3)(b) of this section.
- Documentation of the basis for the determination shall include references to support evidence, and if applicable, the rationale for any interpretation regarding the application of health plan coverage provisions.
- If the determination overrides the health plan's medical necessity or appropriateness standards, the rationale shall document why the health plan's standards are unreasonable or inconsistent with sound, evidence-based medical practice.
- The written report shall include the qualifications of reviewers but shall not disclose the identity of the reviewers.
- Notification of the determination shall be provided initially by phone, e-mail or fax, followed by a written report by mail. In the case of expedited reviews the initial notification shall be immediate and by phone.
WAC 246-305-060 Criteria and considerations for independent review determinations
- General criteria and considerations.
- An IRO's determination must use fair procedures and be consistent with the standards in RCW 43.70.235, 48.43.535, and this chapter.
- The expert reviewers from a certified IRO will make determinations regarding the medical necessity or appropriateness of, and the application of health plan coverage provisions to, health care services for an enrollee.
- The IRO must ensure that determinations are consistent with the scope of covered benefits as outlined in the medical coverage agreement.
- Clinical reviewers may override the health plan's medical necessity or appropriateness standards only if the standards are determined upon review to be unreasonable or inconsistent with sound, evidence-based medical practice.
- Reviewers may make determinations about the application of general health plan coverage provisions to specific issues concerning health care services for an enrollee. For example, whether a specific service is excluded by more general benefit exclusion language may require independent interpretation.
- Medical necessity and appropriateness — Criteria and considerations. Only clinical reviewers may determine whether a service, which is the subject of an adverse decision, is medically necessary and appropriate. These determinations must be based upon their expert clinical judgment, after consideration of relevant medical, scientific, and cost-effectiveness evidence, and medical standards of practice in the state of Washington.
- Medical standards of practice include the standards appropriately applied to physicians or other health care providers, as pertinent to the case.
- In considering medical standards of practice within the state of Washington:
- Clinical reviewers may use national standards of care, absent evidence presented by the health plan or enrollee that the Washington standard of care is different.
- A health care service or treatment should be considered part of the Washington standard of practice if reviewers believe that failure to provide it would be inconsistent with that degree of care, skill and learning expected of a reasonably prudent health care provider acting in the same or similar circumstances.
- Medical necessity will be a factor in most cases referred to an IRO, but not necessarily in all. See WAC 246-305-060 (3).
- Health plan coverage provisions — Criteria and considerations. The following requirements shall be observed when a review requires making determinations about the application of health plan coverage provisions to issues concerning health care services for an enrollee.
- These determinations shall be made by one or more contract specialists meeting the requirements of WAC 246-305-040 (4), except that a clinical determination of medical necessity or appropriateness, by itself, is not an interpretation of the scope of covered benefits and does not require a contract specialist.
- If the full health plan coverage agreement has not already been provided by the carrier pursuant to WAC 284-43-630 (2)(f) of the insurance commissioner, the IRO shall request additional provisions from the health plan coverage agreement in effect during the relevant period of the enrollee's coverage, as necessary to have an adequate context for determinations.
- In general, the IRO and its contract specialists may assume that the contractual health plan coverage provisions themselves are consistent with the Washington Insurance Code (Title 48 RCW), absent information to the contrary. Primary responsibility for determining consistency with the insurance code, when at issue, rests with the insurance commissioner.
- No provision of this chapter should be interpreted to establish a standard of medical care, or to create or eliminate any cause of action.
WAC 246-305-070 Administrative processes and capabilities of independent review organizations
- An IRO must maintain written policies and procedures covering all aspects of review.
- An IRO must ensure the confidentiality of medical records and other personal health information received for use in independent reviews, in accordance with applicable federal and state laws.
- An IRO must have a quality assurance mechanism that ensures the timeliness, quality of review and communication of determinations to enrollees and carriers. The mechanism must also ensure the qualifications, impartiality, and freedom from conflict of interest of the organization, its staff, and expert reviewers.
- The quality assurance program must include a written plan addressing scope and objectives, program organization, monitoring and oversight mechanisms, and evaluation and organizational improvement of IRO activities.
- Quality of reviews includes use of appropriate methods to match the case, confidentiality, and systematic evaluation of complaints for patterns or trends. Complaints must be recorded on a log, including nature of complaint and how resolved. The department reserves the right to examine both the complaints and the log.
- Organizational improvement efforts must include the implementation of action plans to improve or correct identified problems, and communication of the results of action plans to staff and reviewers.
- An IRO must maintain case logs and case files with full documentation of referrals, reviewers, questions posed, information considered (including sources of the information and citations of studies or criteria), determinations and their rationale, communication with parties in the dispute including notices given, and key dates in the process, for at least two years following the review.
- An IRO must maintain a training program for staff and expert reviewers, addressing at least:
- Neutrality and conflict of interest;
- Appropriate conduct of reviews;
- Documentation of evidence for determination; and
- In the case of contract specialists, principles of health contract law and any provisions of Washington law determined to be essential.
- An IRO must maintain business hours, methods of contact (including by telephone), procedures for after-hours requests, and other relevant procedures to ensure timely availability to conduct expedited as well as regular reviews.
- An IRO shall not disclose reviewers' identities. The department will not require reviewers' identities as part of the certification application process but may examine identified information about reviewers as part of enforcement activities.
- An IRO shall promptly report any attempt at interference by any party, including a state agency, to the department.
- An IRO shall have a medical director who holds a current unrestricted license as a medical doctor or osteopathic physician and has had experience in direct patient care. The medical director shall provide guidance for clinical aspects of the independent review process and oversee the IRO's quality assurance and credentialing programs.
WAC 246-305-080 Application for certification as an independent review organization
- To be certified as an independent review organization under this chapter, an organization must submit to the department an application in the form required by the department. The application must include:
- For an applicant that is publicly held, the name of each stockholder or owner of more than five percent of any stock or options;
- The name of any holder of bonds or notes of the applicant that exceed one hundred thousand dollars;
- The name and type of business of each corporation or other organization that the applicant controls or is affiliated with and the nature and extent of the affiliation or control;
- The name and a biographical sketch of each director, officer, and executive of the applicant and any entity listed under (c) of this subsection and a description of any relationship the named individual has with:
- A carrier;
- A utilization review agent;
- A nonprofit or for-profit health corporation;
- A health care provider;
- A drug or device manufacturer; or
- A group representing any of the entities described by (d)(i) through (v) of this subsection;
- The percentage of the applicant's revenues that the applicant anticipates will be derived from reviews conducted under RCW 48.43.535 ;
- A description of the areas of expertise of the health care professionals and contract specialists making review determinations for the applicant, as well as the IRO's policies and standards addressing qualifications, training, and assignment of all types of reviewers;
- The procedures that the independent review organization will use in making review determinations regarding reviews conducted under RCW 48.43.535 ;
- Attestations that all requirements will be met;
- Evidence of accreditations, certifications, and government IRO contracts that the applicant believes demonstrate compliance with certain requirements of this chapter.
- Applicants must authorize release of information from primary sources, including full reports of site visits, inspections and audits;
- The department may require the applicant to indicate which documents demonstrate compliance with specific Washington state certification requirements under this chapter.
- Other documentation, including, but not limited to, legal and financial information, policies and procedures, and data that are pertinent to requirements of this chapter; and
- Any other reasonable application requirements demonstrating ability to meet all requirements for certification in Washington.
- Department investigation and verification activities regarding the applicant may include, but are not limited to:
- Review of application and filings for completeness and compliance with standards;
- On-site survey or examination;
- Primary-source verification with accreditation or regulatory bodies of compliance with requirements which are used to demonstrate compliance with certain standards in this chapter;
- Other means of determining regulatory and accreditation histories; and
- Exercising any power of the department under WAC 246-305-100.
WAC 246-305-090 Ongoing requirements for independent review organizations. A certified IRO shall:
- Comply with the provisions of RCW 43.70.235, 48.43.535(5), and this chapter;
- Cooperate with the department during investigations;
- Provide the department with information requested in a prompt manner;
- Conduct annual self-assessments of compliance with Washington certification requirements;
- File an annual statistical report with the department on a form specified by the department summarizing reviews conducted. The report shall include, but may not be limited to, volumes, types of cases, compliance with timelines for expedited and nonexpedited cases, determinations, number and nature of complaints, and compliance with conflict of interests rules.
- Submit updated information to the department if at any time there is a material change in the information included in the application.
WAC 246-305-100 Powers of department
- The department may deny, suspend, revoke or modify certification of an IRO if the department has reason to believe the applicant, certified IRO, its agents, officers, directors, or any person with any interest therein has failed or refused to comply with the requirements established under this chapter.
- The department may conduct an on-site review, audit, and examine records to investigate complaints alleging that an applicant, certified IRO or reviewer committed conduct described in WAC 246-305-110.
WAC 246-305-110 Grounds for action against an applicant or a certified IRO
- The department may deny an application for certification or suspend, revoke or modify certification if the applicant, certified IRO, its agents, officers, directors, or any person with any interest therein:
- Knowingly or with reason to know makes a misrepresentation of, false statement of, or fails to disclose, a material fact to the department. This applies to any data attached to any record requested or required by the department or matter under investigation or in a self-inspection;
- Obtains or attempts to obtain certification by fraudulent means or misrepresentation;
- Fails or refuses to comply with the requirements of RCW 43.70.235, 48.43.535(5), or this chapter;
- Conducts business or advertising in a misleading or fraudulent manner;
- Refuses to allow the department access to records, or fails to promptly produce for inspection any book, record, document or item requested by the department, or willfully interferes with an investigation;
- Accepts referral of cases from the insurance commissioner under RCW 48.43.535 without certification or with certification which has been terminated or is subject to sanction;
- Was the holder of a license, certification or contract issued by the department or by any competent authority in any state, federal, or foreign jurisdiction that was terminated for cause and never reissued, or sanctioned for cause and the terms of the sanction have not been fulfilled;
- Had accreditation from a recognized national or state IRO accrediting body that was terminated for cause and never reissued, or sanctioned for cause and the terms of the sanction have not been fulfilled;
- Willfully prevents, interferes with, or attempts to impede in any way the work of any representative of the department and the lawful enforcement of any provision of this chapter. This includes, but is not limited to: Willful misrepresentation of facts during an investigation, or administrative proceeding or any other legal action; or use of threats or harassment against any patient, client, customer, or witness, or use of financial inducements to any patient, client, customer, or witness to prevent or attempt to prevent him or her from providing evidence during an investigation, in an administrative proceeding, or any other legal action involving the department;
- Willfully prevents or interferes with any department representative in the preservation of evidence;
- Misrepresented or was fraudulent in any aspect of the conduct of business;
- Within the last five years, has been found in a civil or criminal proceeding to have committed any act that reasonably relates to the person's fitness to establish, maintain, or administer an IRO;
- Violates any state or federal statute, or administrative rule regulating the IRO;
- Fails to comply with an order issued by the secretary or designee;
- Uses interference, coercion, discrimination, reprisal, or retaliation against a patient, client, or customer exercising his or her rights;
- Offers, gives, or promises anything of value or benefit to any federal, state, or local employee or official for the purpose of influencing that employee or official to circumvent federal, state, or local laws, regulations, or ordinances governing the certification holder or applicant;
- A person, including, but not limited to, enrollees, carriers, and providers, may submit a written complaint to the department alleging that a certified IRO committed conduct described in this section.
- An applicant or certified IRO may contest a department decision or action according to the provisions of RCW 43.70.115, chapter 34.05 RCW, and chapter 246-10 WAC.