Preproposal statement of inquiry was filed as WSR 99-20-035.
Title of Rule: Chapter 246-130 WAC, Human immunodeficiency virus (HIV) early intervention program.
Purpose: The HIV early intervention program helps eligible persons with HIV infection in Washington state pay for prescription medications and other services to treat HIV infection. Chapter 246-130 WAC identifies the services the program offers, how the department decides what services to offer, how clients may access the services, how providers are reimbursed, and how the public may provide input.
Statutory Authority for Adoption: RCW 43.70.040.
Statute Being Implemented: RCW 43.70.120.
Summary: The changes the department is proposing for chapter 246-130 WAC are intended to make the rules more user-friendly and clarify the program's policies and procedures.
Reasons Supporting Proposal: The HIV client services program receives a substantial amount of funding from the federal government, and the provisions of chapter 246-130 WAC help clarify that the program has sufficient legal basis and programmatic infrastructure necessary to use those funds.
Name of Agency Personnel Responsible for Drafting: Pamela J. Hayes, Box 47844, Olympia, WA 98504-7844, (360) 236-3402; Implementation and Enforcement: Raleigh Watts, Box 47841, Olympia, WA 98504-7841, (360) 236-3477.
Name of Proponent: Washington State Department of Health, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The changes that the department is proposing for chapter 246-130 WAC are intended to make the chapter more user-friendly and to clarify the program's policies and procedures. The proposed amendments will help Washington state residents who are infected with HIV understand what services the Department of Health offers and how they can access them. The chapter was last amended in 1995 and since that time the program's enrollment and use of resources has grown considerably. The proposed amendment to chapter 246-130 WAC identifies what services the HIV client services program offers, and how it makes programmatic decisions regarding the provision of those services. Finally, the existing rule language is fairly broad and much of it contains legalistic phrasing that is difficult for people to follow. The proposed language is clearer and easier to comprehend. Also, it provides more complete program information that helps the reader understand more about how the program operates and how the public can access more information.
Proposal Changes the Following Existing Rules: One of the critical areas in which it provides more clarity is the section that defines who is eligible for the program (WAC 246-130-040). The additional detail describes how the program makes eligibility decisions and reinforces the public's ability to affect those decisions. As with other eligibility criteria, the proposed changes stress that the public has the opportunity to affect financial eligibility rules. Another section in which the department proposes to add clarifying detail is WAC 246-130-030, which describes how the HIV client services program interacts with the medical providers who are contracted with the program to provide services for its clients. The proposed changes add detail that informs providers what they must do to receive payment for their services, and stresses that the contract between the department and the providers defines the legal relationship that allows the agency to reimburse them for their services.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
RCW 43.70.040 describes the general rule-making authority of the secretary of the Department of Health. The purpose of the statute is to allow the secretary to adopt rules that protect public health. RCW 43.70.120 requires the Department of Health to adopt rules that are necessary to allow the department to receive federal funds. The HIV client services program receives a substantial amount of funding from the federal government, and the provisions of chapter 246-130 WAC help clarify that the program has sufficient legal basis and programmatic infrastructure necessary to receive those funds.
The changes that the department is proposing to make to chapter 246-130 WAC are intended to make the chapter more user-friendly and to clarify the program's existing policies and procedures. The proposed amendments will help Washington state residents who are HIV positive understand what services the Department of Health offers and how they can access them. The chapter was last amended in 1995 and since that time the program's enrollment and use of resources has grown considerably. The proposed amendment to chapter 246-130 WAC will help Washington state residents understand what services the HIV client services program offers, and how it makes programmatic decisions regarding the provision of those services.
Small Business Economic Impact Statements: Pursuant to requirements of the Regulatory Fairness Act (act), state agencies must prepare a small business economic impact statement (SBEIS) prior to proposing a new regulation. The impetus for this legislation was a concern that regulatory mandates could "...threaten the very existence of some small businesses" (RCW 19.85.011). The act defines a small business as "any business entity, including a sole proprietorship, corporation, partnership, or other legal entity, that is owned and operated independently from all other businesses, that has the purpose of making a profit, and that has fifty or fewer employees" (RCW 19.85.020).
The Department of Health prepared this SBEIS as required by the Regulatory Fairness Act. The department used the following process to determine whether the act mandates that the proposed rule include regulatory relief for small businesses.
|Step I||Determine the categories of businesses affected by the proposed regulations.|
|Step II||Determine the employment profile for each business category.|
|Step III||Determine the "more than minor" cost threshold.|
|Step IV||Determine whether the estimated cost exceeds the "more than minor" cost threshold for each category of business.|
|Step V||Determine whether the proposed regulation imposes a disproportionate cost burden on small businesses.|
|Step VI||Determine whether regulatory relief is legal and feasible.|
|Step VII||Describe the regulatory relief provided to small businesses.|
|Step VIII||Miscellaneous SBEIS requirements.|
Step I: What businesses are affected by the proposed regulation? The businesses affected by the proposed regulation are health care providers contracted by the department to supply pharmaceutical, medical, dental or laboratory services to clients of the early intervention program (EIP). These businesses are represented by the following SIC codes: 591 = pharmaceutical; 805 = medical; 802 = dental; and 807 = laboratory.
Step II: What is the employment profile of businesses affected by the proposed regulation? The health care providers affected by the proposed revision are both small and large. For the purposes of this analysis the department will consider the costs to two categories of provider businesses: 0-49 employees (small) and over 50 (large).
Step III: What are the "more than minor" cost thresholds for businesses affected by the proposed regulation? An SBEIS is required whenever a regulation imposes "more than minor" costs on a regulated business. The "more than minor" thresholds were developed by the Washington State Business Assistance Center (Department of Community, Trade and Economic Development) and the amount is dependent on a business' SIC code. The threshold for SIC codes in the three digit 591 and 805 categories are $50; for 802 the threshold is $170, and for 807 the threshold is $300. For ease of analysis the department will consider anything over $50 as the threshold for "more than minor" costs for all the codes.
Step IV: Do the costs imposed by the proposed rule exceed the "more than minor" cost threshold? The proposed regulations do not impose any new costs and therefore do not exceed the "more than minor" thresholds. The revisions only clarify how the department will provide reimbursement to contracted providers. The proposed changes to chapter 246-130 WAC do not result in additional costs to HIV positive individuals, members of the affected community, or contracted medical service providers. The revision more clearly describes the services offered and the criteria that it uses to determine program eligibility. The department and members of the affected community who developed the draft amendment worked hard to ensure that the proposed changes capture and describe in WAC the manner in which the HIV client services program should operate. The intent of amending the chapter is to make it clearer and easier to use, not to make programmatic changes that affect critical items such as cost or program-provider relationships.
The current WAC has a broad statement that says the department will reimburse contracted providers for services they provide to eligible clients and that the department will produce a schedule of reimbursement for covered services. The following are examples of clarification of the department's relationship with providers in the proposed WAC. WAC 246-130-030 answers the question of how the department pays providers. It states the department will pay contracted providers for covered services, and that the providers must bill within one hundred eighty days from the date of service. Subsection (3) says that payment depends upon availability of funds, and that the department will provide written notice to clients and providers before it reduces its schedule of covered services. Subsection (4) says that must use contractual procedures to solve disputes. Subsection (5) requires providers to bill according to the terms of their contracts, and subsection (6) defines the department as the payer of last resort.
Step V: Does the proposed regulation impose a disproportionate cost burden on small businesses? The proposed regulation does not impose a disproportionate cost burden on small business because there is no change in cost burden to either small or large businesses. The cost of contracting with the department under the WAC revision is unchanged and will be the same, no matter the size of the operation.
Step VI: Is regulatory relief for small businesses necessary, legal and feasible? There is no need for regulatory relief for small businesses because the proposed revision does not impose a disproportionate cost burden on small businesses.
Step VII: Miscellaneous SBEIS requirements: How did the department involve affected businesses and other interested parties in the development of the rule? The department solicited stakeholder input from the beginning of the revision process. The Early Intervention Program Steering Committee participated in the initial review that determined that the existing rule was basically sound, that it did not require major changes, but that it would be useful to amend the chapter to make it easier to understand and use. The steering committee includes a pharmacist from a large employer, and physician from a large employer, and representatives from not-for-profit agencies. In addition, drafts of the proposed revision have been sent to a large mailing list of "interested persons" that includes some businesses affected by the rules such as pharmaceutical companies and health consultants. The CR-102 will be mailed to all contracted medical and dental providers.
A copy of the statement may be obtained by writing to Raleigh Watts, P.O. Box 47841, Olympia, WA 98504-7841 or firstname.lastname@example.org, phone (360) 236-3477, fax (360) 664-2216.
RCW 34.05.328 applies to this rule adoption. DOH staff reviewed the revisions to the existing WAC and determined that it meets the definition of a "significant legislative rule." Therefore, we analyzed the probable costs and benefits of the revisions, taking into account both the qualitative and quantitative benefits and costs. The analysis revealed that no new costs will be imposed, existing costs will not be increased, and benefits to businesses will not be decreased.
Hearing Location: WestCoast SeaTac Hotel, Seattle Room, 18415 Int'l Boulevard (Pacific Highway South), SeaTac, WA, on August 21, 2000, at 11:00 a.m.
Assistance for Persons with Disabilities: Contact Raleigh Watts (email@example.com) by August 10, 2000, TDD (800) 833-6388, or (360) 236-3477.
Submit Written Comments to: Raleigh Watts, HIV Client Services, P.O. Box 47841, Olympia, WA 98504-7841, fax (360) 664-2216, by August 21, 2000.
Date of Intended Adoption: August 30, 2000.
June 29, 2000
M. C. Selecky
AMENDATORY SECTION(Amending WSR 95-23-018, filed 11/7/95, effective 12/8/95)
Purpose.)) What is the HIV early
The department shall administer federal
and state funds appropriated to assist eligible persons with HIV
infection to access early intervention services.)) The early
intervention program provides treatment of HIV infection to
eligible clients based on available funds. The department
provides these early intervention services to improve the public
health by treating people living with HIV, its complications, and
side effects of HIV treatment, and in order to decrease the risk
of clients with HIV infecting others. Information on how to
contact this program is in WAC 246-130-090.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-001, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-001, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-010, filed 8/17/90, effective 9/17/90. Statutory Authority: RCW 43.20A.550. 87-22-012 (Order 2549), § 248-168-010, filed 10/26/87.]
The following words and phrases have the following meaning
in chapter 246-130 WAC ((
unless the context clearly indicates
"AIDS" means acquired immunodeficiency syndrome.
"APDP" means HIV/AIDS prescription drug program.
"Department" or "DOH" means the Washington state department of health.
"Early intervention services" means personal health services and behavioral risk reduction interventions codelivered with these services that reduce the rate of progression of HIV infection and reduce HIV transmission.
"HIP" means the HIV intervention program.
"HIV" means human immunodeficiency virus.
"Participation" means the amount of cost borne by the eligible client.
"Personal health services" mean clinical interventions and treatments, including but not limited to medications, that are delivered to individuals and are intended to reduce morbidity and mortality.)) (1) "AIDS" means acquired immunodeficiency syndrome.
(2) "Applicant" means a person applying for early intervention program services.
(3) "Client" means a person determined to be currently eligible by the department for early intervention program services.
(4) "Department" means the Washington state department of health.
(5) "Early intervention program services" means medically necessary treatment and services that reduce the rate of progression of HIV infection and HIV transmission. This includes behavioral risk reduction interventions. See WAC 246-130-020 for details.
(6) "Federal poverty level" means the official income level for poverty released by the federal government each year in February.
(7) "Formulary" means the list of prescription drugs that the early intervention program will pay for. To obtain a copy of that list, see WAC 246-130-090.
(8) "HIV" means human immunodeficiency virus.
(9) "Medical assistance administration (MAA)" means the part of the department of social and health services responsible for operating the state's Medicaid and related medical programs.
(10) "Provider" means a health care professional contracted by the department to supply pharmaceutical, medical, dental, or laboratory services to a client.
(11) "Schedule of services" means the department's list of medical, dental, and laboratory services covered by its early intervention program. To obtain a copy of that list, see WAC 246-130-090.
(12) "Standard of care" means treatment for HIV commonly accepted by the local medical community.
(13) "Steering committee" means the department's HIV early intervention steering committee. This advisory committee serves at the pleasure of the DOH secretary per RCW 43.70.040(2), consists of Washington state residents living with HIV and HIV medical experts and community organizations, and advises the department on its early intervention program. Its bylaws are available from the department per WAC 246-130-090.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-010, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.120. 92-02-018 (Order 224), § 246-130-010, filed 12/23/91, effective 1/23/92. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-015, filed 8/17/90, effective 9/17/90.]
To the extent
federal or state funds are appropriated for the purpose of
providing services through HIP or APDP, the department shall
contract with participating pharmacies, other health care
providers, or social service providers for the delivery of early
intervention services.)) Services to treat HIV are available from
the department, based on available funding, to eligible clients
as described in this section.
(1) The department decides what specific medical, laboratory, dental, and prescription medication services to cover after actively consulting with its steering committee and considering:
(a) Support of the steering committee, which represents clients and local medical HIV/AIDS communities;
(b) FDA approval (for prescription medications);
(c) Recognition by the medical community as a standard of care;
(d) Effectiveness in treatment for HIV, complications of HIV, side effects of current treatments for HIV or support for HIV treatment adherence; and
(e) Relative cost of services.
(2) The early intervention program services described in this section are available to all clients, unless they receive those services from other sources. Specific services of this section are available for a client only when medically necessary to treat HIV and associated diseases, complications of treating HIV, or support for HIV treatment adherence.
(3) Specific covered medical, laboratory, and dental services are listed in the department's "schedule of services."
(4) Prescription drugs covered are listed in the department's "early intervention drug formulary."
(5) Covered health insurance includes:
(a) Premium payment, including COBRA premiums;
(b) Deductible payment up to five hundred dollars per twelve-month period; and
(c) Co-pay payment for third-party insurance, except basic health plan, as follows:
(i) The percentage of prescription medication costs covered by the department and not covered by third-party insurers; and
(ii) Fixed dollar co-pay required by a client's third-party insurance plan.
(d) For basic health plan enrollees, the department pays the percentage of prescription medication expenses not covered by the basic health plan but covered by the department's early intervention program formulary.
(6) The department may also coordinate other services to treat HIV and AIDS. These are available as funding and contracting permit. For example, as of July 1, 2000, the department may pay the spend-down for MAA medically needy (MN) clients who are also DOH clients, up to one thousand one hundred dollars per month.
(7) You may contact the department per WAC 246-130-090 to make comments on service coverage or to receive information.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-020, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-020, filed 8/17/90, effective 9/17/90. Statutory Authority: RCW 43.20A.550. 87-22-012 (Order 2549), § 248-168-020, filed 10/26/87.]
The department does not cover any services which are:
(1) Not specified or referenced in WAC 246-130-020; or
(2) Not funded as specified in WAC 246-130-030(3).
The department will make reimbursement to
contracted providers to provide early intervention services to
eligible persons. The department shall produce a schedule of
reimbursement for all services covered on a fee-for-service basis
that shall be applicable to all contracted providers.)) The
department pays providers for covered services delivered to
clients, as limited by this section.
(1) The department pays providers who contract with the department for services described in WAC 246-130-020.
(a) The department will only pay for services delivered by a contracted provider.
(b) Services must be billed within one hundred eighty days of being provided.
(2) The department only pays for covered, medically necessary early intervention program services delivered to clients who are eligible under WAC 246-130-040.
(3) Payment of services depends on availability of federal and state funds. The department will not deny payment of any individual claim for funding availability unless the department denies an entire class of claims, or an entire program.
(a) Providers and clients will receive written notice of any limitation or reduction in coverage or payment that results from loss of federal or state funding at least thirty days in advance.
(b) If the department denies or reduces payment for any class of claims or program, it must only show that it made a good faith effort to mail written notice to all providers and clients.
(4) Providers who dispute a payment may do so though the contracts process. See WAC 246-130-080(3).
(5) Providers must bill the department per terms of the contract between the provider and department.
(6) The department is payer of last resort.
(a) Providers must bill all other third-party sources prior to billing the department for covered services, and
(b) Providers must reimburse the department for any funds paid by the department, which are payable by other sources.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-030, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.120. 92-02-018 (Order 224), § 246-130-030, filed 12/23/91, effective 1/23/92. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-030, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-030, filed 8/17/90, effective 9/17/90. Statutory Authority: RCW 43.20A.550. 87-22-012 (Order 2549), § 248-168-030, filed 10/26/87.]
The department shall provide early
intervention services for persons with HIV infection, including
those persons with disabling AIDS conditions, who meet financial
eligibility requirements established by the department and who
are not receiving similar services funded by other resources. Prior to their application, the department shall publish and seek
public comment upon the process and criteria for establishing
medical and financial eligibility for early intervention
services. The department shall provide for public involvement in
establishing and periodically reviewing these criteria, including
seeking input from clients and providers of early intervention
The following exemptions shall not be considered in determining financial eligibility for early intervention services:
(1) A home, defined as real property owned by an eligible client as a principal place of residence, together with the property surrounding and contiguous thereto not to exceed five acres;
(2) Commercial property, or property used for the purpose of producing income, except to the extent that its value exceeds the sum of twenty thousand dollars;
(3) Household furnishings;
(4) An automobile;
(5) Savings, property, or other liquid assets, to the extent the value thereof does not exceed the sum of ten thousand dollars;
(6) Proceeds whether lump sum or annuities from a viatical settlement contract; and
(7) Accelerated benefits of a life insurance policy whether in lump sum or annuities.)) (1) The department determines client eligibility for its early intervention program per this section. Beginning the month that the applicant's completed application was postmarked, an applicant is eligible for twelve months of early intervention program services when:
(a) The applicant has a medical diagnosis of HIV (the department may require a doctor's diagnosis);
(b) The applicant has a Washington state address and intends to stay in Washington state;
(c) The applicant or his/her designated representative has submitted truthful information on the department's application form to the department;
(d) The applicant has monthly income, averaged over twelve months, equal to or less than the limit set by DOH in consultation with the early intervention program steering committee. For example: In 2000, that limit was three hundred seventy percent of Federal Poverty Level for one person ($2,575) per month. The department shall announce and seek public comment on proposed changes to the income limit. Income includes:
(i) Wages, salary, overtime, tips, and bonuses;
(ii) Social Security, trust funds for disability, or other disability insurance payments;
(iii) Unemployment benefits;
(iv) Veteran's Administration benefits;
(v) Lump sum payments of gifts, cash inheritance, property, lottery winnings, worker's compensation for lost income, or severance pay;
(vi) Private pensions, annuities, or royalties; and
(vii) Investment dividends.
(e) The applicant has current resources of less than ten thousand dollars. Resources include trust funds, and any other financial resources available to the applicant. The department does not count the following as resources:
(i) One home, defined as real property owned by the client as his or her principal place of residence in Washington state, together with surrounding property not to exceed five acres;
(ii) Commercial property, or property used for producing income, up to the first twenty thousand dollars of value;
(iii) Household furnishings;
(iv) One automobile; or
(v) Pensions and other Internal Revenue Service designated retirement accounts;
(f) The applicant is not currently eligible for or cannot access medical benefits from the department of social and health services; and
(g) The applicant is not currently an inmate of any correctional institute or jail or will not be when their application is approved.
(2) Periods of eligibility caused by false information may cause the department to:
(a) Disenroll a client from the department's early intervention program; and
(b) Recover funds paid by the department during periods of false eligibility.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-040, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.120. 92-02-018 (Order 224), § 246-130-040, filed 12/23/91, effective 1/23/92. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-040, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-040, filed 8/17/90, effective 9/17/90. Statutory Authority: RCW 43.20A.550. 87-22-012 (Order 2549), § 248-168-040, filed 10/26/87.]
An individual seeking early intervention
services shall provide medical and financial information upon
request of the department including:
(1) Sources and amounts of resources to verify financial eligibility;
(2) Evidence that all other available resources or entitlements for which a person is eligible were accessed before a person could receive early intervention services through HIP or APDP; and
(3) Other medical or financial information as required by the department.)) An applicant seeking early intervention program services must apply to the department.
(1) Applicant and client information supplied to the department is confidential.
(2) Applicants must provide medical and financial information at the department's request, including:
(a) Sources and amounts of all income and resources;
(b) Evidence that all resources or entitlements available to an applicant were accessed before that applicant applied for or received early intervention program services; and
(c) Other medical or financial information.
(3) Clients must notify the department of medical or financial changes that affect their eligibility within twenty days of the change. Clients who do not notify the department of medical or financial changes must pay back to the department funds provided during the period of ineligibility caused by those changes.
[Statutory Authority: RCW 43.70.040 and 43.70.120. 95-23-018, § 246-130-060, filed 11/7/95, effective 12/8/95. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-130-060, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.120. 90-17-087 (Order 071), § 248-168-060, filed 8/17/90, effective 9/17/90. Statutory Authority: RCW 43.20A.550. 87-22-012 (Order 2549), § 248-168-060, filed 10/26/87.]
Applicants and clients may appeal any decision by the department about their early intervention program eligibility or coverage.
(1) Chapter 246-10 WAC details the adjudicated proceeding for matters involving receipt of benefits. The department will provide information on the cause for denied benefits, how a proceeding may be requested, the forms necessary to request a proceeding and information on required time frames.
(2) Applicants and clients may not appeal the department's denial or limitations when the department closes or limits an early intervention program service due to funding availability. See WAC 246-130-030(3) for more details.
(3) Rate and payment disputes between providers and the department are handled by contract.
(4) Clients of any other public agency must use that agency's process to resolve eligibility or other disputes regarding that agency. MAA's fair hearings process is described in chapter 388-08 WAC.
For information or application, contact:
Department of Health
P.O. Box 47841
Olympia, WA 98504-7841
Telephone 1-800-272-2437 Option 2
Or, visit the WEB site at www.doh.wa.gov. Clicking on "HIV Information" accesses information about the early intervention program.
The following section of the Washington Administrative Code is repealed: