WSR 00-22-119

PROPOSED RULES

OFFICE OF THE

INSURANCE COMMISSIONER

[ Filed November 1, 2000, 11:47 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 00-12-086.

Title of Rule: Patient bill of rights.

Purpose: The proposed rules will implement the recently enacted "patient bill of rights," chapter 5, Laws of 2000 (E2SSB 6199).

Other Identifying Information: R 2000-02.

Statutory Authority for Adoption: 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.

Statute Being Implemented: RCW 48.43.500, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535.

Summary: The commissioner is proposing new rules to implement the recently enacted "patient bill of rights," chapter 5, Laws of 2000 (E2SSB 6199). These rules address six of the seven areas of that [what] will be the subject of rules: Information disclosure; access to health care services; insurer review of health care (utilization review); grievance processes; and independent review organizations. Several of these subjects require the commissioner to adopt rules.

Reasons Supporting Proposal: RCW 48.43.500 states the intent of the legislature in requiring or allowing the commissioner to adopt rules. The reasons include improved access to information, improved access to and choice of providers, a quick and impartial process to appeal decisions, privacy protection, and secure health information. The proposed rules seek to achieve these goals and the other consumer protection goals stated in the "patient bill of rights."

Name of Agency Personnel Responsible for Drafting: John Conniff, Olympia, Washington, (360) 664-3786; Implementation: Donna Dorris, Olympia, Washington, (360) 586-5590; and Enforcement: Jeff Coopersmith, Lacey, Washington, (360) 407-0734.

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 legislature granted rule-making authority or mandated rules to implement the patient bill of rights. Many of the subjects addressed by the new law cannot be implemented by their effective dates without rules. In each instance, the legislature expressly provided that the commissioner consider national and local standards to create more detailed guidance for insurers. Many of the provisions of the new law are general and leave to the commissioner the authority to establish comprehensive standards. The proposed rules provide for more detailed guidance, particularly in the areas of utilization review, and grievance processes in order to create uniform standards across all health plans.

Proposal Changes the Following Existing Rules: Proposed WAC 284-43-130 is amended to expand the definition of health plan to mirror the scope of the law.

     Proposed WAC 284-43-200 is amended to clarify existing procedures and to provide criteria to assess the adequacy of access of providers.

     Proposed WAC 284-43-610 is amended to delete the definition of "clinical review criteria" which is no longer necessary.

     Proposed WAC 284-43-620 is amended to include the need for expeditious independent review if delay would jeopardize the covered person's life or materially jeopardize their health. An additional new subsection allows for carrier recovery of costs for services incurred during the time when services are provided while a denial decision of the carrier is appealed and the carrier decision is ultimately affirmed.

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

Small Business Economic Impact Statement

     Overview: On March 15 of 2000, Governor Locke signed E2SSB 6199, the "patient bill of rights." The legislation was codified at chapter 5, Laws of 2000. The new law requires the commissioner to adopt rules on a wide variety of subjects and provides authority to adopt rules on additional subjects. On June 6 of 2000, the commissioner filed a CR-101 announcing her intention to begin the rule-making process to [no further information supplied by agency.]

     This rule making is intended to begin the process of implementing E2SSB 6199 by addressing many of the subject areas. The legislature granted rule-making authority or mandated rules to implement the patient bill of rights. Many of the subjects addressed by the new law cannot be implemented by their effective dates without rules. In each instance, the legislature expressly provided that the commissioner consider national and local standards to create more detailed guidance for insurers. Many of the provisions of the new law are general and leave to the commissioner the authority to establish comprehensive standards. More detailed guidance is particularly necessary for privacy, utilization review, and grievance processes in order to create uniform standards across all health plans.

     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 codes that would be affected by the proposed rules include Hospital and Medical Service Plans, industry code #6324 and health plans offered by Accident and Health Insurers, industry code #6321. In Washington, hospital and medical service plans are called health care service contractors (HCSCs) and health maintenance organizations (HMOs). Public programs, including those under RCW 74.09.522, chapters 70.47 and 41.05 RCW are also impacted by many provisions of these rules, except to the extent otherwise provided in statute.

     List the specific parts of the proposed rule which may impose a cost to business: Proposed WAC 284-43-130 is not expected to incur any costs traceable to the rules. It applies the scope set forth in E2SSB 6199, section 19 to the rule making. The amendment states that the provisions of chapter 284-43 WAC apply to plans of specified state programs except to the extent otherwise required by their governing statutes. Not every provision of the new rules or chapter 284-43 WAC apply to each specified program and plan.

     Proposed WAC 284-43-200 elaborates the current network adequacy regulatory scheme and reiterates provisions of RCW 48.43.515. Criteria in proposed subsection (4) provide direction to carriers about adequacy but allow for flexibility in terms of geographic and provider availability. Proposed subsection (7) is designed to provide carriers with the most possible options to solve existing access problems with the Indian health care system. Carriers are encouraged to meet the current challenges with any system that works best for them within the framework of the rule, and other state and federal law.

     Proposed WAC 284-43-251 restates RCW 48.43.515. It should not impose costs.

     Proposed WAC 284-43-400 provides definitions for use in utilization review. Proposed WAC 284-43-410 states the general utilization review standards. Both sections apply, with few exceptions, national standards considered by the commissioner under RCW 48.43.520. The generally accepted national standards and best practices are standards that many of the health carriers state they already follow; the standards adopted by URAC (also known as the American Accreditation Health Care Commission). There may be little or no costs to the carriers currently using these standards. There may be some costs to carriers who are not currently meeting the threshold of these standards. Subsections (g), (h), and (i) vary slightly from URAC and attempt to address some areas of provider contract relationships that have troubled providers and carriers. These sections should not incur more than nominal costs. They seek to avoid penalizing providers based on information not available to the provider, new or changed protocols that are not communicated to the provider, or care that had prior authorization of the carrier (unless the authorization was based on intentional material misrepresentations that the intended by the provider to obtain coverage.)

     Proposed WAC 284-43-610 deletes an existing subsection. No costs are expected.

     Proposed WAC 284-43-615 establishes general grievance and complaint procedures. It restates statutory requirements of RCW 48.43.530. No costs are expected.

     Proposed WAC 284-43-620 provides additional direction on the review and appeal of adverse determinations. The major amendment is subsection (7), which provides that carriers may recover costs incurred by the carrier for providing services while a review is pending when the review affirms the carrier's denial of services. This section provides for cost recovery and obviously should incur no net costs.

     Proposed WAC 284-43-630 establishes a framework for the independent review of adverse determinations as required by RCW 48.43.535.

     Proposed WAC 284-43-820 addresses new RCW 48.43.095. The statute is restated. No costs are expected.

     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 health carriers that offer health plans subject to regulation by the insurance commissioner.

     Will the rule impose a disproportionately higher economic burden on small businesses within the four-digit classification? The OIC does not believe that any of the regulated entities impacted by these rules are small businesses for the purposes of chapter 19.85 RCW. Nevertheless, the commissioner is committed to keeping costs proportionate for the smaller carriers. The proposed rules do not impose disproportionately higher costs on smaller carriers.

     Can mitigation be used to reduce the economic impact of the rule on small businesses and still meet the objectives of the proposed rule? The rule does not include any mitigatory tactics to reduce the specific anticipated costs to small business. The mitigatory measures considered in this rule making apply equally to all carriers. The commissioner encourages any suggestions that can accomplish the goals in a more cost-efficient manner and encourages dialogue with all carriers.

     What steps will the commissioner take to reduce the costs of the rule on small businesses? The rule-drafting process will continue and small businesses are invited to comment on any proposed section of the rule and offer suggestions or alternatives. The rule drafters will continue to discuss the proposed rules with industry representatives to discuss methods to reduce any potential costs on smaller carriers. Additionally, the commissioner will provide technical assistance to aid all carriers in understanding and implementing the new rules.

     Which mitigation techniques have been considered and incorporated into the proposed rule? The rules are being proposed as early as possible and with a delayed effective date to enable industry to comment on the proposal and have adequate time to prepare any systemic changes necessary to comply with the rules and laws. The rule drafters will continue to discuss the proposed rules with industry representatives to discuss methods to reduce any potential costs.

     Which mitigation techniques were considered for incorporation into the proposed rule but were rejected, and why? No mitigation techniques were considered for incorporation and then rejected.

     Briefly describe the reporting, record-keeping, and other compliance requirements of the proposed rule. The reporting and record-keeping requirements in the rules are traceable back to the underlying statutes. For example, proposed WAC 284-43-820 restates RCW 48.43.510. The record-keeping and reporting requirements are not a product of the rule but of the statute. For example, RCW 48.43.510(5) requires the annual reports made available to enrollees. That law is restated at WAC 284-43-820(5). There are no substantive costs due to the rule.

     List the kinds of professional services that a small business is likely to need in order to comply with the reporting, record-keeping, and other compliance requirements of the proposed rule. A small business is not likely to need any additional professional services because of the proposed rules. There may be some need for services directly traceable to the underlying statutes but it is not apparent that the rules will occasion the need for additional staffing or professional services. If carriers or small carriers believe that additional staffing or services are needed due to these rules (and not the underlying statutes), they are encouraged to cite the section that would require the staffing and recommend methods to ameliorate the need if at all possible.

     The commissioner will seek to provide whatever technical assistance is necessary to enable the smaller carriers to understand and implement the rule.

     Analyze the cost of compliance including, specifically:      Cost of equipment: There is no anticipated additional cost of equipment.

     Cost of supplies: There are no anticipated cost of supplies attributable to the rule. The disclosure provisions are required by statute.

     Cost of labor: It is not anticipated that the rule will be responsible for additional cost of labor. There are always costs associated with reading and comprehending any rule changes but it is believed that these costs are nominal. The OIC does not expect that any additional staff will be required as a result of this rule.

     Cost of increased administration: There is no significant anticipated increased cost of administration attributable to the rules. There are no additional filings required. As noted previously, proposed WAC 284-43-200 elaborates the current network adequacy regulatory scheme and reiterates provisions of RCW 48.43.515. However, new criteria in proposed subsection (4) provide direction to carriers about network adequacy. Meeting these standards may incur some costs but the rules are designed to allow for the flexibility in terms of geographic and provider availability. Proposed subsection (7) is designed to provide carriers with the most possible options to solve existing access problems with the Indian health care system. Carriers are encouraged to meet the current challenges with any system that works best for them within the framework of the rule, and other state and federal law. There are administration costs associated with proposed WAC 284-43-400 and 284-43-410, the utilization review standards. As noted previously, the commissioner considered national standards as required by the underlying statute, RCW 48.43.520. The generally accepted national standards and best practices are standards that many of the health carriers state they already follow; the standards adopted by URAC (also known as the American Accreditation Health Care Commission). There may be little or no costs to carriers who currently utilize these standards. There may be some cost for the carriers who are not currently meeting the threshold of these standards. Subsections (g), (h), and (i) vary slightly from URAC and attempt to address some areas of provider contract relationships that have troubled providers and carriers. These sections should not incur more than nominal costs.

     Compare the cost of compliance for small business with the cost of compliance for the largest business in the same four-digit classification: The cost of compliance for small business will be proportional for all carriers, large and small. As noted, many of the costs are traceable to the underlying laws, not these rules. The costs associated with the rules should be relative to the size of the carriers and their enrollee population. Examples are network adequacy and utilization review.

     The rule drafters will consider any suggested alternatives that accomplish the goals of the rules while mitigating the costs of compliance, particularly those costs incurred by small businesses.

     Have businesses that will be affected been asked what the economic impact will be? The rule drafters have been in on-going discussions with affected carriers regarding implementation of the "patient bill of rights" since the passage of the law. Since the laws were drafted with industry knowledge and participation and most of the costs are attributable to the rules, it is safe to say that the great majority of economic impacts have been known and discussed with carriers for close to a year. There may [be] some impacts that are new to some carriers in these rules but the majority are known and have been discussed. Comments were solicited in the CR-101 and subject areas of discussion were enumerated. The commissioner notified all affected carriers that she intended to hold informational hearings in July on the prospective rules in Seattle, Spokane, Yakima, and Vancouver. Carriers were encouraged to participate in the dialogue with the consumers, providers, and commissioner's staff.

     The rule drafters will continue to discuss the proposed rules with industry representatives to ascertain methods to reduce any potential costs.

     How did the commissioner involve small business in the development of the proposed rule? All affected carriers were notified of the beginning of formal rule making by the CR-101, which was mailed to impacted parties in June and posted on the commissioner's website. Comments were solicited in the CR-101 and subject areas of discussion were enumerated. The commissioner notified all affected carriers that she intended to hold informational hearings in July on the prospective rules in Seattle, Spokane, Yakima, and Vancouver. Carriers were encouraged to participate in the dialogue with the consumers, providers, and commissioner's staff.

     How and when were affected small businesses advised of the proposed rule? As noted above, the CR-101 for this rule was filed on June 6, 2000. It was mailed to interested parties and posted on the commissioner's website. All affected carriers were informed of the time and location of informational hearings held by the commissioner in July and topic areas of discussion.

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

RCW 34.05.328 applies to this rule adoption. The rules are "significant legislative rules" for the purposes of RCW 34.05.328.

Hearing Location: Senate Hearing Room 4, John Cherberg Building, 14th and Water, Olympia, Washington, on Tuesday, December 12, 2000, at 1:00 - 5:00 p.m.

Assistance for Persons with Disabilities: Contact Lori [Lorie] Villaflores by December 11, 2000, 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 December 11, 2000.

Date of Intended Adoption: December 13, 2000.

November 1, 2000

D. J. Patin

Deputy Insurance Commissioner

OTS-4389.4


AMENDATORY SECTION(Amending Matter No. R 98-7, filed 9/8/99, effective 10/9/99)

WAC 284-43-130
Definitions.

Except as defined in other subchapters and unless the context requires otherwise, the following definitions shall apply throughout this chapter.

     (1) "Covered health condition" means any disease, illness, injury or condition of health risk covered according to the terms of any health plan.

     (2) "Covered person" means an individual covered by a health plan including an enrollee, subscriber, policyholder, or beneficiary of a group plan.

     (3) "Emergency medical condition" means the emergent and acute onset of a symptom or symptoms, including severe pain, that would lead a prudent layperson acting reasonably to believe that a health condition exists that requires immediate medical attention, if failure to provide medical attention would result in serious impairment to bodily functions or serious dysfunction of a bodily organ or part, or would place the person's health in serious jeopardy.

     (4) "Emergency services" means otherwise covered health care services medically necessary to evaluate and treat an emergency medical condition, provided in a hospital emergency department.

     (5) "Enrollee point-of-service cost-sharing" or "cost-sharing" means amounts paid to health carriers directly providing services, health care providers, or health care facilities by enrollees and may include copayments, coinsurance, or deductibles.

     (6) "Facility" means an institution providing health care services, including but not limited to hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory, and imaging centers, and rehabilitation and other therapeutic settings.

     (7) "Grievance" means a written complaint submitted by or on behalf of a covered person regarding:

     (a) Denial of health care services or payment for health care services; or

     (b) Issues other than health care services or payment for health care services including dissatisfaction with health care services, delays in obtaining health care services, conflicts with carrier staff or providers, and dissatisfaction with carrier practices or actions unrelated to health care services.

     (8) "Health care provider" or "provider" means:

     (a) A person regulated under Title 18 RCW or chapter 70.127 RCW, to practice health or health-related services or otherwise practicing health care services in this state consistent with state law; or

     (b) An employee or agent of a person described in (a) of this subsection, acting in the course and scope of his or her employment.

     (9) "Health care service" or "health service" means that service offered or provided by health care facilities and health care providers relating to the prevention, cure, or treatment of illness, injury, or disease.

     (10) "Health carrier" or "carrier" means a disability insurance company regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, and a health maintenance organization as defined in RCW 48.46.020.

     (11) "Health plan" or "plan" means any individual or group policy, contract, or agreement offered by a health carrier to provide, arrange, reimburse, or pay for health care service including any policy, contract, or agreement under RCW 74.09.522; the basic health plan offered under chapter 70.47 RCW; and health benefits provided under chapter 41.05 RCW except to the extent otherwise required under the specific governing statutes except the following:

     (a) Long-term care insurance governed by chapter 48.84 RCW;

     (b) Medicare supplemental health insurance governed by chapter 48.66 RCW;

     (c) Limited health care service offered by limited health care service contractors in accordance with RCW 48.44.035;

     (d) Disability income;

     (e) Coverage incidental to a property/casualty liability insurance policy such as automobile personal injury protection coverage and homeowner guest medical;

     (f) Workers' compensation coverage;

     (g) Accident only coverage;

     (h) Specified disease and hospital confinement indemnity when marketed solely as a supplement to a health plan;

     (i) Employer-sponsored self-funded health plans;

     (j) Dental only and vision only coverage; and

     (k) Plans deemed by the insurance commissioner to have a short-term limited purpose or duration, or to be a student-only plan that is guaranteed renewable while the covered person is enrolled as a regular full-time undergraduate or graduate student at an accredited higher education institution, after a written request for such classification by the carrier and subsequent written approval by the insurance commissioner.

     (12) "Managed care plan" means a health plan that coordinates the provision of covered health care services to a covered person through the use of a primary care provider and a network.

     (13) "Medically necessary" or "medical necessity" in regard to mental health services is a carrier determination as to whether a health service is a covered benefit if the service is consistent with generally recognized standards within a relevant health profession.

     (14) "Mental health provider" means a health care provider or a health care facility authorized by state law to provide mental health services.

     (15) "Mental health services" means in-patient or out-patient treatment, partial hospitalization or out-patient treatment to manage or ameliorate the effects of a mental disorder listed in the Diagnostic and Statistical Manual (DSM) IV published by the American Psychiatric Association, excluding diagnoses and treatments for substance abuse, 291.0 through 292.9 and 303.0 through 305.9.

     (16) "Network" means the group of participating providers and facilities providing health care services to a particular health plan.      A health plan network for carriers offering more than one health plan may be smaller in number than the total number of participating providers and facilities for all plans offered by the carrier.

     (17) "Out-patient therapeutic visit" or "out-patient visit" means a clinical treatment session with a mental health provider of a duration consistent with relevant professional standards used by the carrier to determine medical necessity for the particular service being rendered, as defined in Physicians Current Procedural Terminology, published by the American Medical Association.

     (18) "Participating provider" and "participating facility" means a facility or provider who, under a contract with the health carrier or with the carrier's contractor or subcontractor, has agreed to provide health care services to covered persons with an expectation of receiving payment, other than coinsurance, copayments, or deductibles, from the health carrier rather than from the covered person.

     (19) "Person" means an individual, a corporation, a partnership, an association, a joint venture, a joint stock company, a trust, an unincorporated organization, any similar entity, or any combination of the foregoing.

     (20) "Primary care provider" means a participating provider who supervises, coordinates, or provides initial care or continuing care to a covered person, and who may be required by the health carrier to initiate a referral for specialty care and maintain supervision of health care services rendered to the covered person.

     (21) "Preexisting condition" means any medical condition, illness, or injury that existed any time prior to the effective date of coverage.

     (22) "Premium" means all sums charged, received, or deposited by a health carrier as consideration for a health plan or the continuance of a health plan.      Any assessment or any "membership," "policy," "contract," "service," or similar fee or charge made by a health carrier in consideration for a health plan is deemed part of the premium.      "Premium" shall not include amounts paid as enrollee point-of-service cost-sharing.

     (23) "Small group" means a health plan issued to a small employer as defined under RCW 48.43.005(24) comprising from one to fifty eligible employees.

[Statutory Authority: RCW 48.02.060, 48.30.010, 48.44.050, 48.46.200, 48.30.040, 48.44.110 and 48.46.400.      99-19-032 (Matter No. R 98-7), § 284-43-130, filed 9/8/99, effective 10/9/99.      Statutory Authority: RCW 48.02.060, 48.20.450, 48.20.460, 48.30.010, 48.44.020, 48.44.050, 48.44.080, 48.46.030, 48.46.060(2), 48.46.200 and 48.46.243.      98-04-005 (Matter No. R 97-3), § 284-43-130, filed 1/22/98, effective 2/22/98.]


AMENDATORY SECTION(Amending Matter No. R 99-2, filed 1/24/00, effective 3/1/00)

WAC 284-43-200
Network adequacy.

(1) A health carrier shall maintain each plan network in a manner that is sufficient in numbers and types of providers and facilities to assure that all health plan services to covered persons will be accessible without unreasonable delay. Each covered person shall have adequate choice among each type of health care provider. Adequate choice is determined in relation to the number of covered persons who might be expected to seek care from the type of provider whose services are covered by the plan including those types of providers who must be included under WAC 284-43-205.      In the case of emergency services, covered persons shall have access twenty-four hours per day, seven days per week.      The carrier's service area shall not be created in a manner designed to discriminate against persons because of age, sex, family structure, ethnicity, race, health condition, employment status, or socioeconomic status.      Each carrier shall ensure that its networks will meet these requirements by the end of the first year of initial operation((; or, for those plans already in existence, by August 22, 1998)) of the network and at all times thereafter.

     (2) Sufficiency may be established by the carrier with reference to any reasonable criteria used by the carrier, including but not limited to: Provider-covered person ratios by specialty, primary care provider-covered person ratios, geographic accessibility, waiting times for appointments with participating providers, hours of operation, and the volume of technological and specialty services available to serve the needs of covered persons requiring technologically advanced or specialty care.      Evidence of carrier compliance with network adequacy standards that are substantially similar to those standards established by state agency health care purchasers (e.g., the state health care authority and the department of social and health services) and by private managed care accreditation organizations may be used to demonstrate sufficiency.      At a minimum, a carrier will be held accountable for meeting those standards described under WAC 284-43-220.

     (3) In any case where the health carrier has an absence of or an insufficient number or type of participating providers or facilities or an absence of a choice of participating specialists to provide a particular covered health care service, the carrier shall ensure through referral by the primary care provider or otherwise that the covered person obtains the covered service from a provider or facility within reasonable proximity of the covered person at no greater cost to the covered person than if the service were obtained from network providers and facilities, or shall make other arrangements acceptable to the commissioner.

     (4) The health carrier shall establish and maintain adequate arrangements to ensure reasonable proximity of network providers and facilities to the business or personal residence of covered persons. The network shall be established in a manner that does not require a covered person to travel more than thirty minutes by ground transportation to seek the services of a participating provider or facility unless such travel is necessitated by the unique circumstances of the covered person's condition and such travel would both benefit the health of the covered person and would be considered reasonable medical practice within the relevant medical community. In determining whether a health carrier has complied with this provision, the commissioner will give due consideration to the relative availability of health care providers or facilities in the service area under consideration and to the standards established by state agency health care purchasers. Relative availability includes the willingness of providers or facilities in the service area to contract with the carrier under reasonable terms and conditions.

     Whenever a carrier and provider or facility are unable to come to agreement as to the terms and conditions for participation of a provider or facility within a network, either party may demand and obtain mediation to resolve the dispute.

     (5) A health carrier shall monitor, on an ongoing basis, the ability and clinical capacity of its network providers and facilities to furnish health plan services to covered persons.

     (6) Beginning July 1, 2000, the health carrier shall disclose to covered persons that limitations or restrictions on access to participating providers and facilities may arise from the health service referral and authorization practices of participating providers and facilities.      The carrier shall provide instructions to covered persons as to how they can receive details about such practices from their primary care provider or through other formally established processes.      For example, a covered person relying on such instructions or processes could discover if the choice of a particular primary care provider would result in the covered person's inability to obtain a referral to certain other participating providers.

     (7) Each health carrier shall maintain adequate arrangements to ensure that American Indians who are covered persons have access to Indian health care services and facilities that are part of the Indian health system. Carriers shall ensure that such covered persons may obtain covered services from the Indian health system at no greater cost to the covered person than if the service were obtained from network providers and facilities. Carriers are not responsible for credentialing providers and facilities that are part of the Indian health system. Nothing in this subsection prohibits a carrier from limiting coverage to those health services that meet carrier standards for medical necessity, care management, and claims administration.

[Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.030, 48.46.200.      00-04-034 (Matter No. R 99-2), § 284-43-200, filed 1/24/00, effective 3/1/00.      Statutory Authority: RCW 48.02.060, 48.20.450, 48.20.460, 48.30.010, 48.44.020, 48.44.050, 48.44.080, 48.46.030, 48.46.060(2), 48.46.200 and 48.46.243.      98-04-005 (Matter No. R 97-3), § 284-43-200, filed 1/22/98, effective 2/22/98.]


NEW SECTION
WAC 284-43-251
Covered person's access to providers.

(1) Each carrier must allow a covered person to choose a primary care provider who is accepting new patients from a list of participating providers. Covered persons also must be permitted to change primary care providers at any time with the change becoming effective no later than the beginning of the month following the covered person's request for the change.

     (2) Each carrier must have a process whereby a covered person with a complex or serious medical or psychiatric condition may receive a standing referral to a participating specialist for an extended period of time of not less than six months.

     (3) Each carrier shall provide covered persons with direct access to the participating chiropractor of the covered person's choice for covered chiropractic health care without the necessity of prior referral. Nothing in this subsection shall prevent carriers from restricting covered persons to seeing only chiropractors who have signed participating provider agreements or from utilizing other managed care and cost containment techniques and processes. For purposes of this subsection, "covered chiropractic health care" means covered benefits and limitations related to chiropractic health services as stated in the plan's medical coverage agreement, with the exception of any provisions related to prior referral for services.

     (4) Each carrier must provide, upon the request of a covered person, access by the covered person to a second opinion regarding any medical diagnosis or treatment plan from a qualified participating provider of the covered person's choice. The carrier may not impose any charge or cost upon the covered person for such second opinion other than a charge or cost imposed for similar, routine access to care such as an office visit copayment.

     (5) Each carrier must cover services of a primary care provider whose contract with the plan or whose contract with a subcontractor is being terminated by the plan or subcontractor without cause under the terms of that contract for at least sixty days following notice of termination to the covered persons or, in group coverage arrangements involving periods of open enrollment, only until the end of the next open enrollment period. Notice to covered persons shall include information of the covered person's right of access to the terminating provider for an additional sixty days. The provider's relationship with the carrier or subcontractor must be continued on the same terms and conditions as those of the contract the plan or subcontractor is terminating, except for any provision requiring that the carrier assign new covered persons to the terminated provider. A health carrier and participating provider and facility shall provide at least sixty days' written notice to each other before terminating the contract without cause.

     (6) Each carrier shall make a good faith effort to assure that written notice of a termination within fifteen working days of receipt or issuance of a notice of termination is provided to all covered persons who are patients seen on a regular basis by the provider whose contract is terminating, irrespective of whether the termination was for cause or without cause.

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SUBCHAPTER D

UTILIZATION REVIEW
NEW SECTION
WAC 284-43-400
Utilizations review -- Definitions.

As used in this subchapter:

     (1) "Adverse determination and noncertification" means a decision by a health carrier to deny, modify, reduce, or terminate payment, coverage, authorization, or provision of health care services or benefits including the admission to or continued stay in a facility. Such term does not include a decision affecting payment or coverage after the service or benefit has been provided.

     (2) "Certification" means a determination by the carrier that an admission, extension of stay, or other health care service has been reviewed and, based on the information provided, meets the clinical requirements for medical necessity, appropriateness, level of care, or effectiveness under the auspices of the applicable health plan.

     (3) "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 as the ordering provider.

     (4) "Clinical rationale" means a statement which provides additional clarification of the clinical basis for a noncertification determination. The clinical rationale should relate the noncertification determination to the patient's condition or treatment plan, and should supply a sufficient basis for a decision to pursue an appeal.

     (5) "Clinical review criteria" means the written screens, decision rules, medical protocols, or guidelines used by the carrier as an element in the evaluation of medical necessity and appropriateness of requested admissions, procedures, and services under the auspices of the applicable health plan.

     (6) "Initial clinical review" means a clinical review conducted by appropriate licensed or certified health professionals. Initial clinical review staff may approve requests for admissions, procedures, and services that meet clinical review criteria, but must refer requests that do not meet clinical review criteria to peer clinical review for certification or noncertification.

     (7) "Review of service request" means the review of information submitted to the carrier for health care services that do not need medical necessity certification nor result in a noncertification decision.

     (8) "Scripted clinical screening" means screening that may include:

     (a) Accepting structured clinical data (including diagnosis, diagnosis codes, procedures, procedure codes);

     (b) Asking scripted clinical questions;

     (c) Accepting responses to scripted clinical questions; and

     (d) Taking specific action (certification and assignment of length of stay explicitly linked to each of the possible responses). It excludes:

     (i) Applying clinical judgment or interpretation;

     (ii) Accepting unstructured clinical information;

     (iii) Deviating from script;

     (iv) Engaging in unscripted clinical dialogue;

     (v) Asking clinical follow-up questions; and

     (vi) Issuing noncertifications.

     (9) "Structured clinical data" means clinical information that is precise and permits exact matching against explicit medical terms, diagnoses or procedure codes, or other explicit choices, without the need for interpretation.

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NEW SECTION
WAC 284-43-410
Utilization review -- Generally.

(1) Each carrier shall maintain a documented utilization review program description and written clinical review criteria based on reasonable medical evidence. The program must include a method for reviewing and updating criteria. Carriers shall make clinical review criteria available upon request to participating providers. A carrier need not use medical evidence or standards in its utilization review of religious nonmedical treatment or religious nonmedical nursing care.

     (2) The utilization review program shall have staff who are properly qualified, trained, supervised, and supported by explicit written clinical review criteria and review procedures.

     (a) For data collection, intake screening, and "scripted clinical screening," use of nonclinical administrative stall shall be limited to:

     (i) Performance of "review of service requests";

     (ii) Collection and transfer of nonclinical data;

     (iii) Acquisition of structured clinical data; and

     (iv) Scripted clinical screening that does not require evaluation or interpretation of clinical information.

     (b) Nonclinical administrative staff performing the functions of section (a) of this subsection shall:

     (i) Be qualified and fully trained to perform;

     (ii) Be supported by explicit instructions and scripts;

     (iii) Be trained to promptly transfer through an established process, a telephone call for review of services to a clinical reviewer if the review cannot be completed based upon a formal script; and

     (iv) Be monitored by a licensed health professional while performing administrative review.

     (3) Each carrier shall designate a medical director who is licensed under chapter 18.57 or 18.71 RCW. However, a naturopathic or complementary alternative health plan, which provides solely complementary alternative health care to individuals, groups, or health plans, may have a medical director licensed under chapter 18.36A RCW. A health plan or self-insured health plan that offers only religious nonmedical treatment or religious nonmedical nursing care shall not be required to have a medical director.

     (4) Every carrier when conducting an initial clinical review, shall:

     (a) Refer review of services that do not meet initial review criteria to a clinical peer;

     (b) Restrict performance of initial clinical review to individuals who meet both of the following requirements:

     (i) Individuals who are health professionals; and

     (ii) Who possess a current and valid professional license or certificate in Washington state.

     (c) Require initial clinical reviewers to be supported by a physician who has an unrestricted license to practice medicine in Washington state.

     (5) Each carrier shall conduct peer clinical reviews for all cases where a clinical determination to certify cannot be made by initial clinical review. Review shall be conducted by health professionals who are qualified to render a clinical opinion about the medical condition, procedures, and treatment under review and who hold a current unrestricted license in the same licensure or certification category as the ordering provider.

     (6) Health professionals that conduct peer clinical review shall be available within one business day, by telephone or in person, to discuss the determination with the attending physician or order providers.

     (7) Each carrier when conducting routine prospective review, concurrent review, or retrospective review shall:

     (a) Accept information from any reasonably reliable source that will assist in the certification process;

     (b) Collect only the information necessary to certify the admission, procedure or treatment, length of stay, or frequency or duration of services;

     (c) Not routinely require providers or facilities to numerically code diagnoses or procedures to be considered for certification, but may request such codes, if available;

     (d) Not routinely request copies of medical records on all patients reviewed;

     (e) Require only the section(s) of the medical record during prospective review or concurrent review necessary in that specific case to certify medical necessity or appropriateness of the admission or extension of stay, frequency or duration of service;

     (f) For prospective and concurrent review, base review determinations solely on the medical information obtained by the carrier at the time of the review determination;

     (g) For retrospective review, base review determinations solely on the medical information available to the attending physician or order provider at the time the health service was provided;

     (h) Not retrospectively deny coverage for emergency and nonemergency care that had prior authorization under the plan's written policies at the time the care was rendered unless the prior authorization was based upon a material misrepresentation by the provider intended for the purpose of obtaining approval;

     (i) Not retrospectively deny coverage or payment for care based upon standards or protocols not communicated to the provider or facility within a sufficient time period for the provider or facility to modify care in accordance with such standard or protocol; and

     (j) Reverse its certification determination only when information provided to the carrier is materially different from that which was reasonably available at the time of the original determination.

     (8) Each carrier shall reimburse reasonable costs of medical record duplication for reviews.

     (9) Each carrier shall have written procedures to assure that reviews and second opinions are conducted in a timely manner.

     (a) Review determinations must be made within two business days of receipt of the necessary information on a proposed admission or service requiring a review determination.

     (b) The frequency of reviews for the extension of initial determinations must be based upon the severity or complexity of the patient's condition or on necessary treatment and discharge planning activity.

     (c) Retrospective review determinations must be completed within thirty days of receipt of the necessary information.

     (d) Notification of the determination shall be provided to the attending physician or ordering provider or facility and to the covered person within two days of the determination and shall be provided within one day of concurrent review determination. Notification shall include the number of extended days, the next anticipated review point, the new total number of days or services approved, and the date of admission or onset of services.

     (10) No carrier may penalize or threaten a provider or facility with a reduction in future payment or termination of participating provider or participating facility status because the provider or facility disputes the carrier's determination with respect to coverage or payment for health care service.

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SUBCHAPTER F

GRIEVANCE AND COMPLAINT PROCEDURES
AMENDATORY SECTION(Amending Matter No. R 98-17, filed 11/29/99, effective 12/30/99)

WAC 284-43-610
Definitions.

For the purposes of this subchapter:

     (((1))) "Adverse determination" means a decision by a health carrier to deny, modify, reduce, or terminate payment, coverage, authorization, or provision of health care services or benefits including the admission to or continued stay in a facility.      Such term does not include a decision affecting payment or coverage after the service or benefit has been provided.

     (((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.))

[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), § 284-43-610, filed 11/29/99, effective 12/30/99.]


NEW SECTION
WAC 284-43-615
Grievance and complaint procedures -- Generally.

(1) Each carrier must adopt and implement a comprehensive process for the resolution of covered persons' complaints and appeals of adverse determinations.

     (2) This process must conform to the provisions of this chapter and each carrier must:

     (a) 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.

     (b) 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.

     (c) Process as a complaint a covered person's expression of dissatisfaction about customer service or the quality or availability of a health service.

     (d) Implement procedures for registering and responding to oral and written complaints in a timely and thorough manner including the notification of a covered person that a complaint or appeal has been received.

     (e) Assist the covered person with all complaint and appeal processes.

     (f) Cooperate with any representative authorized in writing by the covered person.

     (g) Consider all information submitted by the covered person or representative.

     (h) Investigate and resolve all complaints and appeals.

     (i) Provide information on the covered person's right to obtain second opinions.

     (j) 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.

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AMENDATORY SECTION(Amending Matter No. R 98-17, filed 11/29/99, effective 12/30/99)

WAC 284-43-620
Procedures for ((health care service review decisions)) review and appeal of adverse determinations.

(1) 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.

     (2) 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 would jeopardize the covered person's life or materially jeopardize the person's health, the carrier shall presume the need for expeditious review, including the need for an expeditious determination in any independent 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 appealing an adverse 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 appeals 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 an independent 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.

     (7) When a covered person requests that the carrier reconsider its decision to modify, reduce, or terminate an otherwise covered health service that an enrollee is receiving through the health plan and the carrier's decision is based upon a finding that the health service, or level of health service, is no longer medically necessary or appropriate, the carrier must continue to provide that health service until the appeal is resolved. If the resolution of the appeal or any review sought by the enrollee affirms the carrier's decision, the enrollee may be responsible for the cost of this continued health service. If the carrier elects to recover the costs of such services, the carrier shall accept repayment arrangements consistent with the financial needs and circumstances of the covered person.

[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.]


NEW SECTION
WAC 284-43-630
Independent review of adverse determinations.

(1) 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. 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 upon prior written approval by the commissioner.

     (2) 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:

     (a) Any medical records of the covered person that are relevant to the review;

     (b) 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;

     (c) Any documentation and written information submitted to the carrier in support of the appeal;

     (d) 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;

     (e) The attending or ordering provider's recommendations; and

     (f) The terms and conditions of coverage under the relevant health plan.

     The carrier shall also make available to affected parties 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 affected parties 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.

     (3) 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.

     (4) 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.

     (5) Carriers must implement the certified independent review organization's determination promptly, and must pay the certified independent review organization's charges.

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NEW SECTION
WAC 284-43-820
Health plan disclosures -- Prescription drugs, preventive care, generally.

(1) A carrier that offers a health plan may not offer to sell a health plan to an enrollee or to any group representative, agent, employer, or enrollee representative without first offering to provide, and providing upon request, the following information using a standardized summary format approved by the commissioner before purchase or selection:

     (a) A listing of covered benefits, including prescription drug benefits, if any, and how consumers may be involved in decisions about benefits;

     (b) A listing of exclusions, reductions, and limitations to covered benefits, including definitions of terms such as formulary, generic versus brand name, medical necessity or other coverage criteria and policies regarding coverage of drugs, including how drugs are added or removed from the formulary;

     (c) A statement of the carrier's policies for protecting the confidentiality of health information;

     (d) A statement of the cost of premiums and any enrollee cost-sharing requirements;

     (e) A summary explanation of the carrier's grievance process;

     (f) A statement regarding the availability of a point-of-service option, if any, and how the option operates; and

     (g) A convenient means of obtaining a complete and detailed list of covered benefits including a copy of the current formulary, if any is used, a list of participating primary care and specialty care providers, including disclosure of network arrangements that restrict access to providers within any plan network. The offer to provide the information referenced in this subsection (1) must be clearly and prominently displayed on any information provided to any prospective enrollee or to any prospective group representative, agent, employer, or enrollee representative.

     (2) Upon the request of any person, including a current enrollee, prospective enrollee, or the insurance commissioner, a carrier must provide written information regarding any health care plan it offers, that includes the following written information:

     (a) Any documents, instruments, or other information referred to in the medical coverage agreement;

     (b) A full description of the procedures to be followed by an enrollee for consulting a provider other than the primary care provider and whether the enrollee's primary care provider, the carrier's medical director, or another entity must authorize the referral;

     (c) Procedures, if any, that an enrollee must first follow for obtaining prior authorization for health care services;

     (d) A written description of any reimbursement or payment arrangements, including, but not limited to, capitation provisions, fee-for-service provisions, and health care delivery efficiency provisions, between a carrier and a provider or network;

     (e) Descriptions and justifications for provider compensation programs, including any incentives or penalties that are intended to encourage providers to withhold services or minimize or avoid referrals to specialists;

     (f) An annual accounting of all payments made by the carrier which have been counted against any payment limitations, visit limitations, or other overall limitations on a person's coverage under a plan;

     (g) A copy of the carrier's grievance process for claim or service denial and for dissatisfaction with care; and

     (h) Accreditation status with one or more national managed care accreditation organizations, and whether the carrier tracks its health care effectiveness performance using the health employer data information set (HEDIS), whether it publicly reports its HEDIS data, and how interested persons can access its HEDIS data.

     (3) Each carrier shall provide to all enrollees and prospective enrollees a list of available disclosure items.

     (4) Nothing in this section requires a carrier or a health care provider to divulge proprietary information to an enrollee, including the specific contractual terms and conditions between a carrier and a particular provider.

     (5) No carrier may advertise or market any health plan to the public, including to any employer as a plan that covers services that help prevent illness or promote the health of enrollees unless it:

     (a) Provides all clinical preventive health services provided by the basic health plan, authorized by chapter 70.47 RCW;

     (b) Monitors and reports annually to enrollees on standardized measures of health care and satisfaction of all enrollees in the health plan. Standardized measures for this purpose, include HEDIS, consumer assessment of health plans (CAHP) or other national standardized measurement systems adopted by national managed care accreditation organizations or state agencies that purchase managed health care services and approved by the commissioner; and

     (c) Makes available upon request to enrollees its integrated plan to identify and manage the most prevalent diseases within its enrolled population, including cancer, heart disease, and stroke. Such plans must include means to identify enrollees with these diseases, implement evidence based screening, education, monitoring and treatment protocols, track patient and provider adherence to these protocols, measure health outcomes, and regularly report results to enrollees.

     (6) No carrier may preclude or discourage its providers from informing an enrollee of the care he or she requires, including various treatment options, and whether in the providers' view such care is consistent with the plan's health coverage criteria, or otherwise covered by the enrollee's medical coverage agreement with the carrier. No carrier may prohibit, discourage, or penalize a provider otherwise practicing in compliance with the law from advocating on behalf of an enrollee with a carrier. Nothing in this section shall be construed to authorize a provider to bind a carrier to pay for any service.

     (7) No carrier may preclude or discourage enrollees or those paying for their coverage from discussing the comparative merits of different carriers with their providers. This prohibition specifically includes prohibiting or limiting providers participating in those discussions even if critical of a carrier.

     (8) Each carrier must communicate enrollee information required in this act by means that ensure that a substantial portion of the enrollee population can make use of the information.

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