Original Notice.

Preproposal statement of inquiry was filed as WSR 98-13-090.

Title of Rule: Managed care--Grievance.

Purpose: These rules set standards for expedited review of health care service denials by health carriers when an enrollee's life and health would be jeopardized by the timelines and procedures for more routine enrollee grievances.

Statutory Authority for Adoption: RCW 48.02.060, 48.81.120, 48.20.450, 48.20.460, 48.30.010, 48.43.055, 48.44.050, 48.46.100, and 48.46.200.

Statute Being Implemented: RCW 48.43.055.

Summary: The rule sets standards for review of consumer complaints about denials of benefits. The rule requires health carriers to reconsider denials of health care benefits within fourteen days of an oral or written request by the covered person or her health care provider. The carrier may request a fourteen day extension if the extension would benefit the covered person. If delay would jeopardize the covered person's life or health, the carrier must reconsider a denial and render a decision within seventy-two hours of the request. If the person's doctor says that speed is necessary, the carrier must treat the request as an expedited review. Impartial providers with experience in the covered person's health condition or disease must conduct the review. The carrier must give the covered person and his doctor the actual medical reason for the denial along with any clinical protocols used to make the decision. The carrier cannot punish or threaten to punish a provider who helps the covered person appeal a health care service denial.

Reasons Supporting Proposal: Recent denials of potentially life saving health care services by health carriers and the delays by these carriers in reviewing consumer appeals demonstrate a need for expedited review of health care denials that threaten the life and health of the enrollee. In cases where a health carrier denies payment for treatment, patients cannot obtain the treatment. Each day's delay in reviewing an appeal of the decision to deny payment, threatens the life of the patient and/or the potential success of the treatment should the patient win the appeal. In addition, consumers have complained of inadequate explanation of treatment denials and inadequate training and skills by the reviewer. Doctors have also noted that if the doctor is perceived by a carrier as being too much of an advocate for consumers, the doctor will be removed from the health care network.

Name of Agency Personnel Responsible for Drafting: John S. Conniff, P.O. Box 40255, Olympia, WA, (360) 664-3786; Implementation and Enforcement: Bethany Weidner, P.O. Box 40255, Olympia, WA, (360) 664-8137.

Name of Proponent: Deborah Senn, Insurance Commissioner, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: The rule sets standards for review of consumer complaints about denials of benefits. The rule requires health carriers to reconsider denials of health care benefits within fourteen days of an oral or written requires by the covered person or her health care provider. The carrier may request a fourteen-day extension if the extension would benefit the covered person. If delay would jeopardize the covered person's life or health, the carrier must reconsider a denial and render a decision within seventy-two hours of the request. If the person's doctor says that speed is necessary, the carrier must treat the request as an expedited review. Impartial providers with experience in the covered person's health condition or disease must conduct the review. The carrier must give the covered person and his doctor the actual medical reason for the denial along with any clinical protocols used to make the decision. The carrier cannot punish or threaten to punish a provider who helps the covered person appeal a health care service denial.

Proposal Changes the Following Existing Rules: The proposed rules amend four existing WAC sections to bring grievance review standards for experimental and investigational services into harmony with grievance review standards for other health benefits. The affected sections are WAC 284-44-043, 248-46-507, 284-50-377, and 284-96-015.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Grievance rules have been discussed in rule making in the recent past. Notably, the managed care rules (R 97-3) contemplated rules regarding grievance procedures and the filing of specifically formatted grievance reports. It was decided that the topics merited additional discussion and the grievance proposals were not included in the final rules when they were adopted in January of 1998.

In June of 1998, the commissioner issued a CR-101 announcing her intent to begin the rule-making process regarding a number of health care subjects. Grievance was one of the subjects that was specifically mentioned as an area under consideration. As the rule making progressed, the commissioner decided to narrow the focus of this rule making to just the grievance issues. A new CR-101 was filed to address other subjects.

The proposed rules establish new grievance procedure standards. RCW 48.43.055 requires carriers to file grievance procedures with the commissioner. However, there are no existing standards. The rule sets standards for review of consumer complaints about denials of benefits. The rule requires health carriers to reconsider denials of health care benefits within fourteen days of an oral or written request by the covered person or her health care provider. The carrier may request a fourteen day extension if the extension would benefit the covered person. If delay would jeopardize the covered person's life or health, the carrier must reconsider a denial and render a decision within seventy-two hours of the request. If the person's doctor says that speed is necessary, the carrier must treat the request as an expedited review. Impartial providers with experience in the covered person's health condition or disease must conduct the review. The carrier must give the covered person and his doctor the actual medical reason for the denial along with any clinical protocols used to make the decision. The carrier cannot punish or threaten to punish a provider who helps the covered person appeal a health care service denial.

Recent denials of potentially life saving health care services by health carriers and the delays by these carriers in reviewing consumer appeals demonstrate a need for expedited review of health care denials that threaten the life and health of the enrollee. In cases where a health carrier denies payment for treatment, patients cannot obtain the treatment. Each day's delay in reviewing an appeal of the decision to deny payment, threatens the life of the patient and/or the potential success of the treatment should the patient win the appeal. In addition, consumers have complained of inadequate explanation of treatment denials and inadequate training and skills by the reviewer. Doctors have also noted that if the doctor is perceived by a carrier as being too much of an advocate for consumers, the doctor will be removed from the health care network.

Is the Rule Required by Federal Law or Federal Regulation? This rule is not required by federal law or regulation.

What Industry is Affected by the Proposed Rule? The industry code that would be affected by the proposed rules includes Hospital and Medical Service Plans, industry code #6324. In Washington, these plans are called Health Care Service Contractors (HCSCs) and Health Maintenance Organizations (HMOs). They would apply to individual and group disability carriers, Hospital and Medical Service Plans, industry code #6321

List the Specific Parts of the Proposed Rule, based on the Underlying Statutory Authority (RCW Section), Which May Impose a Cost to Business: The intended result of these proposed requirements is to achieve uniformity in the grievance review process for all carriers, consistent with applicable stature [statute] and regulations. It is not the intent of the proposed rules to provide difficult or costly standards to meet. Instead, the rules are intended to reflect the best practices in the market. All carriers currently have grievance procedures in place. In general, the proposed rules are similar to existing standards of many carriers. The proposed rules will provide protection to consumers by ensuring that carriers will improve or maintain their standards and have consistent, adequate grievance procedures.

All carriers have grievance procedures and all carriers have a process to expedite the procedures in case of a medical emergency. The proposed rules require carriers to respond to request for reconsideration of adverse determinations within fourteen days. The carrier may extend the period by fourteen days if it notifies the covered person that the extension is beneficial to the covered person for some reason, such as allowing additional time for the carrier to consider information that it will take time to acquire. These time frames may be slightly compressed for some carriers. Carriers generally currently respond to requests for review in twenty to thirty days. Some carriers have provisions to extend that time frame if necessary, others do not. Experimental or investigational treatment is reviewed in twenty days or less currently. The proposed rules would establish a uniform time frame of fourteen days for all grievance reviews (except, of course, for emergency reviews).

The proposed rules provide that if the covered person's life or health would be jeopardized by delay, the carrier shall expedite the request and issue a decision within seventy-two hours. This standard parallels other national standards. Currently, all carriers provide for some form of expedited review, many if not the great majority, do so within seventy-two hours. Some carriers allow for the time frame to reflect clinical urgency.

The proposed rules provide that carriers make not punish or threaten providers acting on behalf or in support of a request for expedited review. No costs should be involved here. This is a safeguard for providers that should never affect well-intentioned carriers.

The proposed rules provide that carriers must consider all relevant information submitted. Again, this is a safeguard that should not affect carriers who are acting in good faith.

What Will be the Compliance Costs for the Industries Affected? Any costs these rules may incur would derive from the compression of the time frames. As noted, some carriers will not be affected at all. Few carriers should be affected by the expedited time frame, it reflects national and state standards.

There is always some time and costs associated with reading and comprehending new rules. Those costs should not be significant and the commissioner may be able to offer technical assistance to insurers in this regard.

What Percentage of the Industries in the Four-digit Standard Industrial Classification will be Affected by the Rule? The proposed rule would affect 100% of the carriers that offer health plans subject to regulation by the commissioner.

Will the Rule Impose a Disproportionately Higher Economic Burden on Small Businesses Within the Four-digit Classification? No. All carriers would be held to the same standards and time frames. The proposed rules allow for considerable flexibility while ensuring uniformity and fairness. Smaller carriers may have fewer requests for grievance reviews and should not have any higher than proportional costs.

Can Mitigation be Used to Reduce the Economic Impact of the Rule on Small Businesses and Still Meet the Stated Objective of the Statutes That are the Basis of the Proposed Rule? The current proposed rules are the product of several years of discussion. Many of the provisions of the grievance rules proposed in R 97-3 have been removed to mitigate the economic impact upon all carriers, including smaller carriers. Any costs attributable to the grievance rules have been greatly mitigated. Numerous sections were removed including definitions, provisions regarding levels of grievance review, establishment of a grievance registry, and reporting requirements. The proposed rules allow for considerable flexibility for carriers to continue their current grievance processes while ensuring processes are fair and timely.

What Steps will the Commissioner Take to Reduce the Costs of the Rule on Small Businesses? As noted above, costs on all carriers, including smaller carriers have been greatly mitigated throughout the time these have been discussed. The commissioner will continue to work with all interested parties, including smaller carriers, throughout the rule-making process to mitigate any economic impacts while continuing to meet the objectives of the rule.

Which Mitigation Techniques Have Been Considered and Incorporated Into the Proposed Rule? As stated above, many sections of the proposed rules that have been discussed over time have been removed. This includes many of the most costly provisions.

Which Mitigation Techniques Were Considered for Incorporation Into the Proposed Rule but Were Rejected, and Why? Many of the earlier requests for mitigation have been incorporated or made superfluous by the removal of several sections. It is not believed that any mitigation techniques that are applicable to the remaining sections were rejected. The commissioner will continue to explore mitigation issues for the remaining sections of the proposed rules as the rule-making process continues.

Briefly describe the reporting, recordkeeping, and other compliance requirements of the proposed rule: There are no new reporting or record-keeping requirements as a result of this rule. Earlier proposed versions of grievance procedures rules contained reporting requirements. These sections have been removed.

List the Kinds of Professional Services That a Small Business is Likely to Need in Order to Comply With the Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule:

Cost of Equipment: There is no anticipated additional cost of equipment.

Cost of Supplies: There is no anticipated additional cost of supplies.

Cost of Labor: The cost of labor should decrease for insurers who choose not to file since the filing requirements on the relevant policies are suspended.

Cost of Increased Administration: There may be some minimal costs associated with reading and comprehending the new rule. The commissioner may be able to offer technical assistance to insurers in this regard. As noted above, the time frames of existing grievance procedures used by carriers may be slightly compressed. If carriers have adequate networks, this should not be an administrative burden.

No carriers, including smaller carriers, should not need to employ any additional professional services due to the proposed rules. The commissioner will continue to explore these issues to ensure that smaller carriers will not have to use disproportionately more resources than larger carriers in order to comply with the rules.

Compare the Cost of Compliance for Small Business With the Cost of Compliance for the Largest Business in the Same Four-digit Classification, Using One or More of the Following: Any costs should be proportional for small insurers. All carriers have grievance procedures and all carriers have a process to expedite the procedures in case of a medical emergency. The standards allow for flexibility while requiring the carriers act in good faith. The standards are similar to existing standards used by national organizations and employed by carriers in Washington. The time frames for review are lessened from general standards in place in Washington. This will not necessarily incur costs. Carriers currently have the panels, personnel, and procedures in place. The proposed rules would require a decision in less time than carriers are generally allowing themselves but the compressed time frame may not incur costs since carriers may already be making determinations within the time frames of the proposed rules. Smaller carriers generally will have proportionally fewer enrollees and, logically, fewer decisions that may be submitted for review. If a smaller carrier have adequate review panels in place for their enrollees, the shortened time frame for review should not incur any disproportionate costs in relation to larger carriers. If a smaller carrier (or larger carrier) does not have adequately staffed review panels, the carrier may be in violation of the underlying statute.

Have Businesses That Will Be Affected Been Asked What the Economic Impact Will Be? The CR-101 was filed on June 16, 1998. The CR-101 was published in the Washington State Register and was posted on the Insurance Commissioner's website. Interested parties and all were mailed the CR-101. It outlined various topics and directions that would be considered in the rule making process. The CR-101 requested comments and gave agency contact numbers for parties interested in participating in the rule making process.

As noted earlier, the proposed rules stem from earlier rule-makings (particularly R 97-3) and carriers, including smaller carriers, have had the opportunity to comment on this subject and to work with staff of the Office of the Insurance Commissioner for several years.

How did the Commissioner Involve Small Business in the Development of the Proposed Rule? See above.

How and When Were Affected Small Businesses Advised of the Proposed Rule? All parties were informed of the proposed rule making when the CR-101 was filed on June 16, 1998. The CR-101 was published in the Washington State Register and was posted on the Insurance Commissioner's website. Interested parties and all carriers were mailed the CR-101. The CR-101 outlined various topics and directions that would be considered in the rule-making process. The CR-101 requested comments and gave agency contact numbers for parties interested in participating in the rule-making process.

A copy of the statement may be obtained by writing to Kacy Brandeberry, P.O. Box 40255, Olympia, WA 98504-0255, fax (360) 664-2782, phone (360) 664-3784.

RCW 34.05.328 applies to this rule adoption.

Hearing Location: Seattle Center, Fidalgo Room, (part of the NW rooms), Seattle, Washington, on October 28, 1999, at 10:00.

Assistance for Persons with Disabilities: Contact Lorie Villaflores by October 27, 1999, TDD (360) 407-0409.

Submit Written Comments to: Kacy Brandeberry, P.O. Box 40255, Olympia, WA 98504-0255, e-mail KacyB@oic.wa.gov, fax (360) 664-2782, by October 27, 1999.

Date of Intended Adoption: November 11, 1999.

September 22, 1999

Bethany Weidner

Deputy Insurance Commissioner

OTS-3059.1

AMENDATORY SECTION(Amending Order 92-15, filed 10/21/92, effective 11/21/92)

WAC 284-44-043
Experimental and investigational prescriptions, treatments, procedures, or services--Definition required--Standard for definition--Written notice of denial required--Appeal process required.

(1) Every health care service contract which excludes or limits, or reserves the right to exclude or limit, benefits for any treatment, procedure, facility, equipment, drug, drug usage, medical device, or supply (hereinafter individually and collectively referred to as services) for one or more medical condition or illness because such services are deemed to be experimental or investigational must include within the contract and any certificate of coverage issued thereunder, a definition of experimental or investigational.

(2) The definition of experimental or investigational services must include an identification of the authority or authorities which will make a determination of which services will be considered to be experimental or investigational.  If the health care service contractor specifies that it, or an affiliated entity, is the authority making the determination, the criteria it will utilize to determine whether a service is experimental or investigational must be set forth in the contract and any certificate of coverage issued thereunder.  As an example, and not by way of limitation, the requirement to set forth criteria in the contract and any certificate of coverage issued thereunder may be satisfied by using one or more of the following statements, or other similar statements:

(a) "In determining whether services are experimental or investigational, the plan will consider whether the services are in general use in the medical community in the state of Washington, whether the services are under continued scientific testing and research, whether the services show a demonstrable benefit for a particular illness or disease, and whether they are proven to be safe and efficacious."

(b) "In determining whether services are experimental or investigational, the plan will consider whether the services result in greater benefits for a particular illness or disease than other generally available services, and do not pose a significant risk to health or safety of the patient."

The supporting documentation upon which the criteria are established must be made available for inspection upon written request in all instances and may not be withheld as proprietary.

(3) Every health care service contractor that denies a request for benefits or that refuses to approve a request to preauthorize services, whether made in writing or through other claim presentation or preauthorization procedures set out in the contract and any certificate of coverage thereunder, because of an experimental or investigational exclusion or limitation, must do so in writing within twenty working days of receipt of a fully documented request.  The health care service contractor may extend the review period beyond twenty days only with the informed written consent of the covered individual.  The denial letter must identify by name and job title the individual making the decision and fully disclose:

(a) The basis for the denial of benefits or refusal to preauthorize services;

(b) The procedure through which the decision to deny benefits or to refuse to preauthorize services may be appealed;

(c) What information the appellant is required to submit with the appeal; and

(d) The specific time period within which the company will reconsider its decision.

(4)(a) Every health care service contractor must establish a reasonable procedure under which denials of benefits or refusals to preauthorize services because of an experimental or investigational exclusion or limitation may be appealed.  The appeals procedure may be considered reasonable if it provides that:

(i) A final determination must be made and provided to the appellant in writing within ((twenty working)) fourteen days of receipt of the fully documented appeal.  The health care service contractor may extend the review period beyond ((twenty)) fourteen days only with the informed written consent of the covered individual;

(ii) The appeal must be reviewed by a person or persons qualified by reasons of training, experience and medical expertise to evaluate it; and

(iii) The appeal must be reviewed by a person or persons other than the person or persons making the initial decision to deny benefits or to refuse to preauthorize services.

(b) When the initial decision to deny benefits or to refuse to preauthorize services is upheld upon appeal, the written notice shall set forth:

(i) The basis for the denial of benefits or refusal to preauthorize services; and

(ii) The name and professional qualifications of the person or persons reviewing the appeal.

(c) Disclosure of the existence of an appeal procedure shall be made by the health care service contractor in each contract and any certificate of coverage issued thereunder which contains an experimental or investigational exclusion or limitation.

(5) Whenever a health care service contractor makes an adverse determination, as defined in WAC 284-43-610(1), and delay would jeopardize the covered person's life or health, the health care service contractor must follow the grievance review procedures and time frames in WAC 284-43-620 (2), (3), (4), (5), and (6).

[Statutory Authority: RCW 48.02.060 (3)(a) and 48.44.050.  92-21-099 (Order 92-15), § 284-44-043, filed 10/21/92, effective 11/21/92.]

OTS-2927.1

SUBCHAPTER F

GRIEVANCE PROCEDURES
NEW SECTION
WAC 284-43-610
Definitions.

For the purposes of this subchapter:

(1) "Adverse determination" means a determination by a health carrier that an admission to a facility, availability of health care service, continued stay in a facility, or continued provision of a health care service has been reviewed and, based upon the information provided, does not meet the health carrier's requirements for necessity, appropriateness, health care setting, level of care, or effectiveness, and the requested plan coverage, claim payment, or service is therefore denied, modified, reduced, or terminated.

(2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols, health care service management computer software, and practice guidelines used by the health carrier to determine the necessity and appropriateness of health care services.

[]

(1) A covered person or a provider (regardless of whether the provider is affiliated with the carrier) may request orally or in writing that the carrier reconsider an adverse determination. The carrier must reconsider and notify the covered person of its decision within fourteen days of request unless the carrier notifies the covered person that an extension of an additional fourteen days would be beneficial to the covered person such as the carrier's consideration of information that will take time to acquire.

(2) Whenever a health carrier makes an adverse determination and delay would jeopardize the covered person's life or health, the carrier shall expedite a request for reconsideration and issue a decision no later than seventy-two hours after the request for reconsideration. If the request is made and the need for speed is supported by a health care provider, the carrier shall grant the request for expeditious review.

(3) 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 requesting an expedited determination.

(4) 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.

(5) All reconsiderations must include a review of all relevant information submitted by the covered person or a provider acting on behalf of the covered person.

(6) 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 a reconsideration 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.

[]

OTS-3058.1

AMENDATORY SECTION(Amending Order 92-14, filed 10/21/92, effective 11/21/92)

WAC 284-46-507
Experimental and investigational prescriptions, treatments, procedures, or services--Definition required--Standard for definition--Written notice of denial required--Appeal process required.

(1) Every health maintenance agreement which excludes or limits, or reserves the right to exclude or limit, benefits for any treatment, procedure, facility, equipment, drug, drug usage, medical device, or supply (hereinafter individually and collectively referred to as services) for one or more medical condition or illness because such services are deemed to be experimental or investigational must include within the agreement and any certificate of coverage issued thereunder, a definition of experimental or investigational.

(2) The definition of experimental or investigational services must include an identification of the authority or authorities which will make a determination of which services will be considered to be experimental or investigational.  If the health maintenance organization specifies that it, or an affiliated entity, is the authority making the determination, the criteria it will utilize to determine whether a service is experimental or investigational must be set forth in the agreement and any certificate of coverage issued thereunder.  As an example, and not by way of limitation, the requirement to set forth criteria in the agreement or any certificate of coverage thereunder may be satisfied by using one or more of the following statements, or other similar statements:

(a) "In determining whether services are experimental or investigational, the plan will consider whether the services are in general use in the medical community in the state of Washington, whether the services are under continued scientific testing and research, whether the services show a demonstrable benefit for a particular illness or disease, and whether they are proven to be safe and efficacious."

(b) "In determining whether services are experimental or investigational, the plan will consider whether the services result in greater benefits for a particular illness or disease than other generally available services, and do not pose a significant risk to health or safety of the patient."

The supporting documentation upon which the criteria are established must be made available for inspection upon written request in all instances and may not be withheld as proprietary.

(3) Every health maintenance organization that denies a request for benefits or that refuses to approve a request to preauthorize services, whether made in writing or through other claim presentation or preauthorization procedures set out in the agreement and any certificate of coverage thereunder, because of an experimental or investigational exclusion or limitation, must do so in writing within twenty working days of receipt of a fully documented request.  The health maintenance organization may extend the review period beyond twenty days only with the informed written consent of the covered individual.  The denial letter must identify by name and job title the individual making the decision and fully disclose:

(a) The basis for the denial of benefits or refusal to preauthorize services;

(b) The procedure through which the decision to deny benefits or to refuse to preauthorize services may be appealed;

(c) What information the appellant is required to submit with the appeal; and

(d) The specific time period within which the company will reconsider its decision.

(4)(a) Every health maintenance organization must establish a reasonable procedure under which denials of benefits or refusals to preauthorize services because of an experimental or investigational exclusion or limitation may be appealed.  The appeals procedure may be considered reasonable if it provides that:

(i) A final determination must be made and provided to the appellant in writing within ((twenty working)) fourteen days of receipt of the fully documented appeal.  The health maintenance organization may extend the review period beyond ((twenty)) fourteen days only with the informed written consent of the covered individual;

(ii) The appeal must be reviewed by a person or persons qualified by reasons of training, experience and medical expertise to evaluate it; and

(iii) The appeal must be reviewed by a person or persons other than the person or persons making the initial decision to deny benefits or to refuse to preauthorize services.

(b) When the initial decision to deny benefits or to refuse to preauthorize services is upheld upon appeal, the written notice shall set forth:

(i) The basis for the denial of benefits or refusal to preauthorize services; and

(ii) The name and professional qualifications of the person or persons reviewing the appeal.

(c) Disclosure of the existence of an appeal procedure shall be made by the health maintenance organization in each agreement and any certificate of coverage issued thereunder which contains an experimental or investigational exclusion or limitations.

(5) Whenever a health maintenance organization makes an adverse determination, as defined in WAC 284-43-610(1), and delay would jeopardize the covered person's life or health, the health care service contractor must follow the grievance review procedures and time frames in WAC 284-43-620 (2), (3), (4), (5), and (6).

[Statutory Authority: RCW 48.02.060 (3)(a) and 48.46.200.  92-21-098 (Order 92-14), § 284-46-507, filed 10/21/92, effective 11/21/92.]

OTS-3441.2

AMENDATORY SECTION(Amending Order R 92-17, filed 10/21/92, effective 11/21/92)

WAC 284-50-377
Experimental and investigational prescriptions, treatments, procedures, or service--Definition required--Standard for definition--Written notice of denial required--Appeal process required.

(1) Every individual disability insurance policy which excludes or limits, or reserves the right to exclude or limit, benefits for any treatment, procedure, facility, equipment, drug, drug usage, medical device, or supply (hereinafter individually and collectively referred to as services) for one or more medical condition or illness because such services are deemed to be experimental or investigational must include within the policy a definition of experimental or investigational.

(2) The definition of experimental or investigational services must include an identification of the authority or authorities which will make a determination of which services will be considered to be experimental or investigational.  If the individual disability insurer specifies that it, or an affiliated entity, is the authority making the determination, the criteria it will utilize to determine whether a service is experimental or investigational must be set forth in the policy.  As an example, and not by way of limitation, the requirement to set forth criteria in the policy may be satisfied by using one or more of the following statements, or other similar statements:

(a) "In determining whether services are experimental or investigational, we will consider whether the services are in general use in the medical community in the state of Washington, whether the services are under continued scientific testing and research, whether the services show a demonstrable benefit for a particular illness or disease, and whether they are proven to be safe and efficacious."

(b) "In determining whether services are experimental or investigational, we will consider whether the services result in greater benefits for a particular illness or disease than other generally available services, and do not pose a significant risk to health or safety of the patient."

The supporting documentation upon which the criteria are established must be made available for inspection upon written request in all instances and may not be withheld as proprietary.

(3) Every individual disability insurer that denies a request for benefits or that refuses to approve a request to preauthorize services, whether made in writing or through other claim presentation or preauthorization procedures set out in the policy, because of an experimental or investigational exclusion or limitation, must do so in writing within twenty working days of receipt of a fully documented request.  The individual disability insurer may extend the review period beyond twenty days only with the informed written consent of the covered individual.  The denial letter must identify by name and job title the individual making the decision and fully disclose:

(a) The basis for the denial of benefits or refusal to preauthorize services;

(b) The procedure through which the decision to deny benefits or to refuse to preauthorize services may be appealed;

(c) What information the appellant is required to submit with the appeal; and

(d) The specific time period within which the company will reconsider its decision.

(4)(a) Every individual disability insurer must establish a reasonable procedure under which denials of benefits or refusals to preauthorize services because of an experimental or investigational exclusion or limitation may be appealed.  The appeals procedure may be considered reasonable if it provides that:

(i) A final determination must be made and provided to the appellant in writing within ((twenty)) fourteen working days of receipt of the fully documented appeal.  The individual disability insurer may extend the review period beyond ((twenty)) fourteen days only with the informed written consent of the covered individual;

(ii) The appeal must be reviewed by a person or persons qualified by reasons of training, experience and medical expertise to evaluate it; and

(iii) The appeal must be reviewed by a person or persons other than the person or persons making the initial decision to deny benefits or to refuse to preauthorize services.

(b) When the initial decision to deny benefits or to refuse to preauthorize services is upheld upon appeal, the written notice shall set forth:

(i) The basis for the denial of benefits or refusal to preauthorize services; and

(ii) The name and professional qualifications of the person or persons reviewing the appeal.

(c) Disclosure of the existence of an appeal procedure shall be made by the individual disability insurer in each policy which contains an experimental or investigational exclusion or limitation.

(5) Whenever an individual disability insurer makes an adverse determination, as defined in WAC 284-43-610(1), and delay would jeopardize the covered person's life or health, the individual disability insurer must follow the grievance review procedures and time frames in WAC 284-43-620 (2), (3), (4), (5), and (6).

[Statutory Authority: RCW 48.02.060 (3)(a) and 48.18.120.  92-21-101 (Order R 92-17), § 284-50-377, filed 10/21/92, effective 11/21/92.]

OTS-3442.2

AMENDATORY SECTION(Amending Order R 92-16, filed 10/21/92, effective 11/21/92)

WAC 284-96-015
Experimental and investigational prescriptions, treatments, procedures, or services--Definition required--Standard for definition--Written notice of denial required--Appeal process required.

(1) Every group disability insurance policy which excludes or limits, or reserves the right to exclude or limit, benefits for any treatment, procedure, facility, equipment, drug, drug usage, medical device, or supply (hereinafter individually and collectively referred to as services) for one or more medical condition or illness because such services are deemed to be experimental or investigational must include within the policy and any certificate of coverage issued thereunder, a definition of experimental or investigational.

(2) The definition of experimental or investigational services must include an identification of the authority or authorities which will make a determination of which services will be considered to be experimental or investigational.  If the group disability insurer specifies that it, or an affiliated entity, is the authority making the determination, the criteria it will utilize to determine whether a service is experimental or investigational must be set forth in the policy and any certificate of coverage issued thereunder.  As an example, and not by way of limitation, the requirement to set forth criteria in the policy and any certificate of coverage issued thereunder may be satisfied by using one or more of the following statements, or other similar statements:

(a) "In determining whether services are experimental or investigational, we will consider whether the services are in general use in the medical community in the state of Washington, whether the services are under continued scientific testing and research, whether the services show a demonstrable benefit for a particular illness or disease, and whether they are proven to be safe and efficacious."

(b) "In determining whether services are experimental or investigational, we will consider whether the services result in greater benefits for a particular illness or disease than other generally available services, and do not pose a significant risk to health or safety of the patient."

The supporting documentation upon which the criteria are established must be made available for inspection upon written request in all instances and may not be withheld as proprietary.

(3) Every group disability insurer that denies a request for benefits or that refuses to approve a request to preauthorize services, whether made in writing or through other claim presentation or preauthorization procedures set out in the policy and any certificate of coverage thereunder, because of an experimental or investigational exclusion or limitation, must do so in writing within twenty working days of receipt of a fully documented request.  The group disability insurer may extend the review period beyond twenty days only with the informed written consent of the covered individual.  The denial letter must identify by name and job title the individual making the decision and fully disclose:

(a) The basis for the denial of benefits or refusal to preauthorize services;

(b) The procedure through which the decision to deny benefits or to refuse to preauthorize services may be appealed;

(c) What information the appellant is required to submit with the appeal; and

(d) The specific time period within which the company will reconsider its decision.

(4)(a) Every group disability insurer must establish a reasonable procedure under which denials of benefits or refusals to preauthorize services because of an experimental or investigational exclusion or limitation may be appealed.  The appeals procedure may be considered reasonable if it provides that:

(i) A final determination must be made and provided to the appellant in writing within ((twenty)) fourteen working days of receipt of the fully documented appeal.  The group disability insurer may extend the review period beyond ((twenty)) fourteen days only with the informed written consent of the covered individual;

(ii) The appeal must be reviewed by a person or persons qualified by reasons of training, experience and medical expertise to evaluate it; and

(iii) The appeal must be reviewed by a person or persons other than the person or persons making the initial decision to deny benefits or to refuse to preauthorize services.

(b) When the initial decision to deny benefits or to refuse to preauthorize services is upheld upon appeal, the written notice shall set forth:

(i) The basis for the denial of benefits or refusal to preauthorize services; and

(ii) The name and professional qualifications of the person or persons reviewing the appeal.

(c) Disclosure of the existence of an appeal procedure shall be made by the group disability insurer in each policy and any certificate of coverage issued thereunder which contains an experimental or investigational exclusion or limitation.

(5) Whenever a group disability insurer makes an adverse determination, as defined in WAC 284-43-610(1), and delay would jeopardize the covered person's life or health, the group disability insurer must follow the grievance review procedures and time frames in WAC 284-43-620 (2), (3), (4), (5), and (6).

[Statutory Authority: RCW 48.02.060 (3)(a) and 48.18.120.  92-21-100 (Order R 92-16), § 284-96-015, filed 10/21/92, effective 11/21/92.]

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