PROPOSED RULES
SOCIAL AND HEALTH SERVICES
(Medical Assistance Administration)
Original Notice.
Preproposal statement of inquiry was filed as WSR 02-06-086.
Title of Rule: Chapter 388-540 WAC, Kidney disease program and kidney center services.
CHAPTER 388-540 WAC, KIDNEY DISEASE PROGRAM AND KIDNEY CENTER SERVICES: Amending WAC 388-540-001 Purpose and 388-540-005 Definitions; repealing WAC 388-540-010, 388-540-020, 388-540-030, 388-540-040, 388-540-050 and 388-540-060; and new sections KIDNEY DISEASE PROGRAM (KDP): WAC 388-540-015 Client eligibility, 388-540-025 Eligibility determination, 388-540-035 Transfer of resources, 388-540-045 Provider requirements, 388-540-055 Covered services and 388-540-065 Reimbursement, KIDNEY CENTER SERVICES: WAC 388-540-101 Purpose and scope, 388-540-105 Definitions, 388-540-110 Eligibility, 388-540-120 Provider requirements, 388-540-130 Covered services, 388-540-140 Noncovered services, 388-540-150 Reimbursement, 388-540-160 Items and services included in the composite rate, 388-540-170 Items and services not included in the composite rate, 388-540-180 Laboratory services, 388-540-190 Blood products and services, 388-540-200 Epoetin alpha therapy, and 388-540-210 Injectable drugs given in the kidney center.
Purpose: To reflect operating changes that are necessary to: (1) Comply with federal requirements for Medicaid dialysis reimbursements; and (2) meet Department of Social and Health Services (DSHS) utilization and cost containment initiative (UCCI) budget targets.
Statutory Authority for Adoption: RCW 74.08.090, 74.09.520.
Statute Being Implemented: RCW 74.09.510, 74.09.520(3), and 74.09.522; 42 C.F.R. 405.2101 and 42 C.F.R. 447.325.
Summary: The proposed changes will:
| • | Improve the clarity and completeness of rules for the state-funded kidney disease program; |
| • | Improve the clarity and completeness of rules for MAA's reimbursements to free-standing kidney centers; |
| • | Establish rules for new reimbursement limitations and methodologies. |
Reasons Supporting Proposal: These rules are needed in order to reflect operating changes and reimbursement limitations. Stakeholders have been actively involved in developing the rules. A state plan amendment has been approved.
Name of Agency Personnel Responsible for Drafting: Myra Davis, MAA, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1306; Implementation and Enforcement: Mary Wendt, MAA, P.O. Box 45510, Olympia, WA 98504-5510, (360) 725-1840.
Name of Proponent: Department of Social and Health Services, governmental.
Rule is necessary because of federal law, 42 C.F.R. 405.2101 and 42 C.F.R. 447-325.
Explanation of Rule, its Purpose, and Anticipated Effects: The proposal replaces brief, general language in chapter 388-540 WAC with a more complete description of MAA's kidney disease program (KDP) and rules for reimbursing free-standing kidney centers. The proposal includes new reimbursement methodologies and limitations.
Proposal Changes the Following Existing Rules: There are no substantive operating changes for the kidney disease program.
There are substantive changes in how the Medical Assistance Administration (MAA) reimburses free-standing kidney centers for providing dialysis to MAA clients) other than KDP clients):
| • | A single dialysis session is reimbursed through a single "composite rate payment"; |
| • | Composite rate payments are limited on a per month per client basis; |
| • | Drugs billed to MAA must meet rebate requirements of WAC 388-530-1125; |
| • | Reimbursement for Epoetin alpha is subject to hematocrit and hemoglobin specifications; |
| • | Injectable drugs given in the kidney center are reimbursed up to MAA's published maximum fees. |
A small business economic impact statement has been prepared under chapter 19.85 RCW.
The new rules are needed to clarify and set-apart MAA rules for the state-funded kidney disease program, and to bring MAA rules for free-standing kidney centers into compliance with federal requirements.
The proposed changes:
| • | Update program-related definitions; |
| • | Provide a more complete description of the kidney disease program (KDP); and |
| • | Update department policy for dialysis services in free-standing kidney centers, including limitations and reimbursement methodology: |
| &sqbul; | A single dialysis session is reimbursed through a single "composite rate payment"; |
| &sqbul; | Composite rate payments are limited on a per month per client basis; |
| &sqbul; | Drugs billed to MAA must meet rebate requirements of WAC 388-530-1125; |
| &sqbul; | Reimbursement for Epoetin alpha is subject to hematocrit and hemoglobin specifications; and |
| &sqbul; | Injectable drugs given in the kidney center are reimbursed up to MAA's published maximum fees. |
Preparation of an SBEIS is required when a proposed rule has the potential of placing "a more than minor economic impact" on small businesses.
The Medical Assistance Administration (MAA) has analyzed the proposed rule and concludes:
| • | There is a more than minor economic impact on free-standing kidney centers; |
| • | There is no disproportionate impact on small businesses; and |
| • | The centers are either nonprofit corporations or business sites run by major private for-profit corporations that do not qualify under the definition of small business. |
MAA changed the payment method for the free-standing kidney centers; moving from billed charges for unbundled services to a "composite rate" method. Over this past year MAA has negotiated with CMS in calculating a statewide payment per composite dialysis session for Washington state, including a cost factor for education and support in beginning dialysis. The composite rate was calculated from an average cost of the free-standing kidney centers' dialysis sessions, then inflated from CY 2000 to CY 2002 by the Washington general vendor rate increase for these related years.
MAA, the kidney centers and other stakeholders have made a concerted effort to satisfy all regulatory and budgetary requirements while minimizing, to the extent possible, the negative economic impacts.
EVALUATION OF PROBABLE COSTS AND PROBABLE BENEFITS: As required by RCW 34.05.328 (1)(c), the administration has analyzed the probable costs and probable benefits of the proposed amendments, taking into account both the qualitative and quantitative benefits and costs.
The proposed amendments make significant changes to current rules for free-standing kidney centers. These amendments and reduced reimbursements reflect changes in the federal regulatory environment, critical economic conditions for Washington state and regulatory improvement efforts.
MAA's new payment method will mirror Medicare processes, so there will be only minimal costs of implementation for the centers. However, over the course of the 2001-2003 biennium, the change from billed charges to the composite rate may result in the centers collectively receiving approximately $3,180,000.00 less in revenue.
This is a critical cost savings to MAA and the state of Washington.
Given the financial emergency within state government, and considering that failure to reduce reimbursements could have resulted in loss of federal match for all sums paid above the Medicare rate; MAA concludes the probable benefits outweigh the probable costs.
A copy of the statement may be obtained by writing to Myra Davis, Medical Assistance Administration, P.O. Box 45533, Olympia, WA 98504-5533, phone (360) 725-1306, fax (360) 586-9727.
RCW 34.05.328 applies to this rule adoption. The proposed rule change meets the definition of a significant legislative rule. A determination of the probable costs and benefits is available from the persons listed above.
Hearing Location: Blake Office Park (behind Goodyear Courtesy Tire), 4500 10th Avenue S.E., Rose Room, Lacey, WA 98503, on August 26, 2003, at 10:00 a.m.
Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by August 22, 2003, phone (360) 664-6094, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.
Submit Written Comments to: Identify WAC Numbers, Department of Social and Health Services, Rules Coordinator, Rules and Policies Assistance Unit, mail to P.O. Box 45850, Olympia, WA 98504-5850, deliver to 4500 10th Avenue S.E., Lacey, WA, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., August 26, 2003.
Date of Intended Adoption: Not sooner than August 27, 2003.
June 27, 2003
Brian H. Lindgren, Manager
Rules and Policies Assistance Unit
3237.3KIDNEY ((CENTERS)) DISEASE PROGRAM AND KIDNEY CENTER SERVICES
[Statutory Authority: RCW 74.04.050 and 74.08.090. 00-01-088, § 388-540-001, filed 12/14/99, effective 1/14/00. Statutory Authority: RCW 74.08.090. 93-16-039 (Order 3600), § 388-540-001, filed 7/28/93, effective 8/28/93.]
"Adequate consideration" means that the reasonable value of goods or services received in exchange for transferred property approximates the reasonable value of the property transferred;
"Affiliate" means a facility, hospital, unit, business, or person having an agreement with a kidney center to provide specified services to ESRD patients;
"Application for ((kidney disease program (KDP)))
eligibility" means the form provided by MAA, which the client
completes and submits to the contracted kidney center to
determine KDP eligibility;
"Application documentation" means either a "Medicaid medical determination" letter from the DSHS community services office, or a KDP "client recertification waiver" form.
"Assets" means income, resources, or any real or personal property that a person or the person's spouse owns and could convert to cash to be used for support or maintenance;
"Certification" means the kidney center has determined a client eligible for the KDP for a defined period of time;
"End-stage renal disease (ESRD)" means that stage of
renal impairment which is irreversible and permanent, and
requires dialysis or kidney ((transplantation)) transplant to
ameliorate uremic symptoms and maintain life;
"KDP application period" means the time between the date
((of)) the client signed the completed application for
eligibility and ((certification)) the date the client is
certified for participation in the program;
"KDP client" means a resident of the state who has a
diagnosis of ESRD and meets the financial and medical
eligibility criteria ((to be)) as determined ((eligible by a
contracted kidney center)) by a KDP contractor;
"KDP client recertification waiver for Medicaid review" means a KDP eligibility form that may in some circumstances be used in place of a "Medicaid medical assistance determination letter."
"KDP contract manual" ((is)) means a set of policies and
procedures for ((contracting)) contracted kidney centers;
"KDP contractor" means a kidney center or other ESRD facility that has contracted with the Washington state department of social and health services (DSHS), kidney disease program to provide ESRD-related services to KDP clients.
"Kidney center" means a facility as defined and certified by the federal government to:
(1) Provide ESRD services;
(2) ((Provide the services specified in this chapter; and
(3))) Promote and encourage home dialysis for a client when medically indicated; and
(3) For the purposes of WAC 388-540-032 through 388-540-060, it is a facility that has entered into a contract with Washington state department of social and health services (DSHS), kidney disease program to provide ESRD-related services.
"Kidney disease program (KDP)" ((is)) means a ((public))
state-funded program that ((helps)) provides financial
assistance to eligible clients with the costs of ESRD-related
medical care;
"Medicaid medical assistance determination letter" means a medical assistance client eligibility letter from the DSHS community services office.
(("Recertifying client" means a KDP client who was
determined eligible the previous year for the KDP and will
continue to qualify under this chapter;))
"Resident" means a person who lives in Washington state on more than a temporary basis.
"Substantial financial change" means((:
(1) The elimination of a client's required annual deductible amount; or
(2))) the increase or decrease of income or assets ((by
fifteen hundred dollars)) that may affect eligibility.
[Statutory Authority: RCW 74.04.050 and 74.08.090. 00-01-088, § 388-540-005, filed 12/14/99, effective 1/14/00. Statutory Authority: RCW 74.08.090, 74.04.005 and 74.08.025. 98-06-025, § 388-540-005, filed 2/24/98, effective 3/27/98. Statutory Authority: RCW 74.08.090. 93-16-039 (Order 3600), § 388-540-005, filed 7/28/93, effective 8/28/93.]
(1) Be a Washington state resident;
(2) Be diagnosed with end-stage renal disease (ESRD);
(3) Be determined ineligible for Medicaid;
(4) Exhaust or be ineligible for all other resources providing similar benefits;
(5) Have countable income which is equal to or less than:
(a) Two hundred percent of the federal poverty level (FPL) or;
(b) Three hundred percent of the FPL with an annual deductible required equal to the income amount which is in excess of two hundred percent of the FPL.
(6) Have countable resources that are either equal to or less than fifteen thousand dollars, or are exempt. Exempt resources are:
(a) A home, defined as real property owned by a client as principal place of residence together with surrounding and contiguous property, not to exceed five acres;
(b) Household furnishings; and
(c) An automobile.
(7) The effective date of eligibility is the first day of the month the application for eligibility is signed by the client.
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(1) The KDP contractor must:
(a) Inform the client of the requirements for KDP eligibility as defined in this chapter and provide the client with necessary department forms and instructions;
(b) Determine client eligibility using department policies, rules, and instructions; and
(c) Forward the completed application for eligibility, and the application documentation to the KDP program manager at the medical assistance administration (MAA). (The KDP program manager may amend or terminate a client's certification period within thirty days of receipt if the application is incomplete or inaccurate.)
(2) A person applying for KDP must:
(a) Complete the application for eligibility and submit any necessary documentation to the kidney center;
(b) Apply for Medicaid, obtain a written Medicaid medical assistance determination letter, submit a copy to the kidney center; and
(c) Apply for Medicare.
(3) A client reapplying for continued eligibility must:
(a) Complete the KDP application for eligibility and submit any documentation necessary to determine eligibility to the kidney center;
(b) Apply for Medicaid forty-five days before the end of the KDP certification period, obtain a written Medicaid eligibility determination, and submit a copy to the kidney center; or
(c) Have applied for Medicaid within the previous five years and continue to be ineligible.
(4) The KDP application period is:
(a) One hundred and twenty days for a new client; and
(b) Forty-five days prior to the end of a certification period for a client requesting recertification.
(5) The KDP contractor may request an extension of application time limits from MAA when extenuating circumstances prevent the client from completing the application or recertification process within the specified time limits.
(6) The KDP contractor certifies the client for no more than one year from the first day of the month of application, unless the client:
(a) Needs medical coverage for less than one year; or
(b) Has a substantial financial change, in which case the client must complete a new application for eligibility.
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(a) Be a Medicare-certified end-stage renal disease (ESRD) facility; and
(b) Have a valid KDP client services contract with the department.
(2) The KDP contractor must provide, directly or through an affiliate:
(a) Professional consultation, personal instructions, medical treatment and care, drug products and all supplies necessary for carrying out a medically-sound end-stage renal disease (ESRD) treatment program;
(b) Dialysis for clients with ESRD when medically indicated;
(c) Kidney transplant treatment, either directly or by referral, when medically indicated;
(d) Treatment for conditions directly related to ESRD such as anemia or venous access infections; and
(e) Supplies and equipment for home dialysis.
(3) The provider must maintain adequate records for audit and review purposes, including:
(a) Medical charts and records that meet the requirements of WAC 388-502-0020; and
(b) Eligibility determination records.
(4) The contractor must meet other obligations as required by their contract with the KDP program.
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(1) Mandatory services that must be provided by the KDP contractor:
(a) Dialysis:
(i) Center dialysis -- Covers the cost of dialysis and related services provided in a kidney center;
(ii) Home dialysis -- Covers the cost of providing dialysis and related services in the home; and
(iii) Dialysis while hospitalized -- Covers the cost of dialysis and related services while the client is confined to an acute care facility and is unable to dialyze at his/her regular site.
(b) Medication -- As defined in the approved drug list in the KDP manual.
(2) Optional services that may be provided by the KDP contractor:
(a) Venous access surgery -- Covers costs associated with surgically preparing the client for dialysis and medical complications related to the venous access site;
(b) Laboratory tests and x-rays considered to be part of the overall treatment plan for ESRD;
(c) Post-transplant visit to assess client's ESRD status; and
(d) Health insurance premiums including co-pays and deductibles, when found to be cost-effective.
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(a) Within the limits of legislative funding for the program;
(b) According to the terms of each kidney center's contract with the department; and
(c) According to the provisions of the KDP contract manual.
(2) The KDP contractor must submit the following documentation to MAA:
(a) A description of the services for which reimbursement is requested; and
(b) Statement of client's financial eligibility for the KDP.
(3) MAA limits KDP reimbursement for out-of-state services to fourteen days per calendar year. Reimbursement is paid only to KDP contractors. Out-of-state dialysis providers must operate under sub-contract or agreement with an in-state KDP contractor in order to receive reimbursement under this program.
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KIDNEY CENTER SERVICES
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"Acute dialysis" means dialysis given to patients who are not ESRD patients, but who require dialysis of temporary kidney failure due to a sudden trauma (e.g., traffic accident or ingestion of certain drugs, etc.).
"Affiliate" means a facility, hospital, unit, business, or person having an agreement with a kidney center to provide specified services to ESRD patients.
"Agreement" means a written document executed between an ESRD facility and another facility in which the other facility agrees to assume responsibility for furnishing specified services to patients and for obtaining reimbursement for those services.
"Back-up dialysis" means dialysis given to a patient under special circumstances, in a situation other than the patient's usual dialysis environment. Examples are:
(1) Dialysis of a home dialysis patient in a dialysis facility when patient's equipment fails;
(2) Inhospital dialysis when the patient's illness requires more comprehensive care on an inpatient basis;
(3) Pre- and post-operative dialysis provided to transplant patients.
"Composite rate" means a payment method in which all standard equipment, supplies, and services are calculated into a blended rate. All in-facility dialysis and all home dialysis treatments are billed under the composite rate system.
"Continuous ambulatory peritoneal dialysis (CAPD)" means a type of dialysis where the patient's peritoneal membrane is used as the dialyzer. The patient dialyzes at home, using special supplies, but without the need for a machine. (See "Peritoneal dialysis.")
"Continuous cycling peritoneal dialysis (CCPD)" means a type of peritoneal dialysis where the patient dialyzes at home and utilizes an automated peritoneal cycler for delivering dialysis.
"Dialysate" means an electrolyte solution, containing elements such as potassium, sodium chloride, etc., surrounding the membrane or fibers and allowing exchange of substances with the patient's blood in the dialyzer.
"Dialysis" means a process by which dissolved substances are removed from a patient's body by diffusion from one fluid compartment to another across a semipermeable membrane.
"Dialysis session" means the period of time beginning when the patient arrives at the facility and ending when the patient departs from the facility. In the case of home dialysis, the time period beginning when the patient prepares for dialysis and ending when the patient is disconnected from the machine.
"Dialyzer" means the synthetic porous membrane or fibers, contained in a supporting structure, through which blood flows for the purpose of eliminating harmful substances, and replacing them with useful ones.
"Drug-related supplies" means nonpharmaceutical items necessary for administration or delivery of a drug.
"Durable medical equipment (DME)" means equipment that:
(1) Can withstand repeated use;
(2) Is primarily and customarily used to serve a medical purpose;
(3) Generally is not useful to a person in the absence of illness or injury; and
(4) Is appropriate for use in the client's place of residence.
"End-stage renal disease (ESRD)" means the stage of renal impairment that is irreversible and permanent, and requires dialysis or kidney transplant to ameliorate uremic symptoms and maintain life.
"Epoetin alpha (EPO)" means the biologically engineered protein that stimulates the bone marrow to make new red blood cells. It is used in the treatment of anemia.
"Free-standing kidney center" means a limited care facility, not operated by a hospital, certified by the federal government to provide ESRD services.
"Hemodialysis" means a method of dialysis in which blood from a patient's body is circulated through an external device or machine and then returned to the patient's bloodstream. Hemodialysis is usually done in a kidney center or facility. It can be done at home with a trained dialysis helper.
"Home dialysis" means any dialysis performed at home.
"Home dialysis helper" means a person trained to assist the client in home dialysis.
"In-facility dialysis," for the purpose of this chapter only, in-facility dialysis means dialysis of any type performed on the premises of a kidney center or other free-standing ESRD facility.
"Intermittent peritoneal dialysis (IPD)" means a type of peritoneal dialysis in which dialysis solution is infused into the peritoneal cavity, allowed to remain there for a period of time, and then drained out. IPD is usually done in a kidney center or facility. It can be done at home with a trained home dialysis helper.
"Kidney center" means a facility as defined and certified by the federal government to:
(1) Provide ESRD services;
(2) Provide the services specified in this chapter; and
(3) Promote and encourage home dialysis for a client when medically indicated.
"Maintenance dialysis" means the usual periodic dialysis treatments given to a client who has ESRD.
"Peritoneal dialysis" means a procedure that introduces dialysate into the abdominal cavity to remove waste products through the peritoneum. Three forms of peritoneal dialysis are continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis, and intermittent peritoneal dialysis.
"Self-dialysis unit" means a unit in a free-standing kidney center where dialysis is performed by an ESRD client who has completed training in self-dialysis.
"Standard ESRD lab tests" means certain laboratory tests that the Centers for Medicare and Medicaid include in their composite rate calculations. These tests are identified in MAA's kidney center billing instructions.
"Take home drugs" means outpatient prescription drugs that are administered outside of a provider's office.
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(a) Categorically needy program (CNP);
(b) Children's health insurance program (CHIP);
(c) Medically indigent program (MI) (Emergency hospital and ambulance only);
(d) General assistance-unemployable (GAU);
(e) Limited casualty program -- Medically needy program (MNP); or
(f) Qualified Medicare beneficiary (QMB) -- (MAA pays only for Medicare premium, co-insurance and deductible);
(2) Managed care enrollees must have dialysis services arranged directly through their designated plan.
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(1) Be a Medicare-certified end-stage renal disease (ESRD) facility and have a signed core provider agreement with MAA (see chapter 388-502 WAC);
(2) Meet requirements found in chapter 388-502 WAC;
(3) Provide only those services within the scope of their provider's license; and
(4) Provide, either directly or through an affiliate, all physical facilities, professional consultation, personal instructions, medical treatment, care, and all supplies necessary for carrying out an medically-sound ESRD treatment program, including all of the following:
(a) Dialysis for ESRD clients;
(b) Kidney transplant treatment, either directly or by referral, for ESRD clients when medically indicated;
(c) Treatment for conditions directly related to ESRD;
(d) Training and supervision of supporting personnel and clients for home dialysis, medical care, and treatment; and
(e) Supplies and equipment for home dialysis.
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(a) In-facility dialysis;
(b) Home dialysis;
(c) Training for self-dialysis;
(d) Home dialysis helpers;
(e) Dialysis supplies;
(f) Diagnostic lab work;
(g) Treatment for anemia; and
(h) Intravenous drugs.
(2) Covered services are subject to the limitations specified by MAA. Providers must obtain prior authorization (PA) or expedited prior authorization (EPA) before providing services that exceed specified limits in quantity, frequency or duration (refer to WAC 388-501-0165 for the PA process).
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(a) Blood and blood products (refer to WAC 388-540-190);
(b) Personal care items such as slippers, toothbrushes, etc.; or
(c) Additional staff time or personnel costs. Staff time is paid through the composite rate. Home dialysis helpers are the only personnel cost paid outside the composite rate (refer to WAC 388-540-160).
(2) MAA reviews all initial requests for noncovered services based on WAC 388-501-0165.
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(a) Composite rate payments -- This is a payment method in which all standard equipment, supplies and services are calculated into a blended rate.
(i) A single dialysis session and related services are reimbursed through a single composite rate payment (refer to WAC 388-540-160).
(ii) Composite rate payments for continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD) are limited to thirty-one per month for an individual client.
(iii) Composite rate payments for all other types of dialysis sessions are limited to fourteen per month for an individual client.
(b) Noncomposite rate payments -- End-stage renal disease (ESRD) services and items covered by the medical assistance administration (MAA) but not included in the composite rate are billed and paid separately (refer to WAC 388-540-170).
(2) Limitation extension request -- MAA evaluates billings for covered services that are subject to limitations or other restrictions, and approves such services beyond those limitations or restrictions when medically necessary, under the standards of WAC 388-501-0165.
(3) Take-home drugs -- MAA reimburses kidney centers for take-home drugs only when they meet the conditions described in WAC 388-540-170(1). Other drugs for at-home use must be billed by a pharmacy and be subject to MAA pharmacy rules.
(4) Medical nutrition -- Medical nutrition products must be billed by a pharmacy or a durable medical equipment (DME) provider.
(5) Medicare eligible clients -- MAA does not reimburse kidney centers as a primary payer for Medicare eligible clients.
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(a) Medically necessary dialysis equipment;
(b) All dialysis services furnished by the facility's staff;
(c) Standard end-stage renal disease laboratory tests (refer to WAC 388-540-180);
(d) Home dialysis support services including delivery, installation, and maintenance of equipment;
(e) Purchase and delivery of all necessary dialysis supplies;
(f) Declotting of shunts and any supplies used to declot shunts;
(g) Oxygen and the administration of oxygen;
(h) Staff time used to administer blood and nonroutine parenteral items;
(i) Noninvasive vascular studies; and
(j) Training for self-dialysis and home dialysis helpers.
(2) The medical assistance administration (MAA) issues a composite rate payment only when all of the above items and services are furnished or available at each dialysis session.
(3) If the facility fails to furnish or have available any of the above items, MAA does not pay for any part of the items and services that were furnished.
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(1) Drugs related to treatment, including but not limited to epoetin alpha (EPO) and diazepam. The drug must:
(a) Be prescribed by a physician;
(b) Meet the rebate requirements described in WAC 388-530-1125; and
(c) Meet the requirements of WAC 246-905-020 when provided for home use.
(2) Supplies used to administer drugs and blood;
(3) Blood processing fees charged by the blood bank (refer to WAC 388-540-190); and
(4) Home dialysis helpers.
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(a) Standard end-stage renal disease (ESRD) lab tests are included in the composite rate when performed at recommended intervals (see billing instructions for current list).
(b) The standard ESRD lab tests referred to in (a) of this subsection can be reimbursed separately from the composite rate only when it is medically necessary to test more frequently:
(i) Proof of medical necessity must be documented in the client's medical record when billing for more frequent testing. A diagnosis of end-stage renal disease is not sufficient;
(ii) The claim must include information on the nature of the illness or injury (diagnosis, complaint or symptom) requiring the performance of the test(s); or
(iii) An ICD-9CM diagnosis code may be shown in lieu of a narrative description.
(2) All separately-billable, ESRD laboratory services must be billed by and reimbursed to the lab that performs the test.
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(a) Blood processing and other fees assessed by non-profit blood centers that do not charge for the blood or blood products themselves; and
(b) Costs incurred by the center to administer its in-house blood procurement program.
(2) MAA does not reimburse centers for blood or blood products (refer to WAC 388-550-6500).
(3) Staff time used to administer blood or blood products is reimbursed only through the composite rate (refer to WAC 388-540-150 and 388-540-160).
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(1) Administered in the kidney center to a client:
(a) With a hematocrit less than thirty-three percent or a hemoglobin less than eleven when therapy is initiated; or
(b) Continuing EPO therapy with a hematocrit between thirty and thirty-six percent.
(2) Provided to a home dialysis client:
(a) Under the same hematocrit/hemoglobin guidelines as stated in (1)(a) and (b) of this section; and
(b) When permitted by Washington Board of Pharmacy Rules. (Refer to WAC 246-905-020 Home dialysis program -- Legend drugs.)
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The following sections of the Washington Administrative Code are repealed:
| WAC 388-540-010 | Services. |
| WAC 388-540-020 | Reimbursement. |
| WAC 388-540-030 | KDP eligibility requirements. |
| WAC 388-540-040 | Transfer of resources without adequate consideration. |
| WAC 388-540-050 | Fiscal information. |
| WAC 388-540-060 | KDP eligibility determination. |