WSR 15-11-059 PROPOSED RULES HEALTH CARE AUTHORITY (Washington Apple Health) [Filed May 18, 2015, 2:28 p.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: WAC 182-540-101, 182-540-105, 182-540-120, 182-540-130, 182-540-140, 182-540-150, 182-540-160, 182-540-170, 182-540-190, 182-540-200, and 182-540-210, kidney center services.
Hearing Location(s): Health Care Authority (HCA), Cherry Street Plaza Building, Sue Crystal Conference Room 106A, 626 8th Avenue, Olympia, WA 98504 (metered public parking is available street side around building. A map is available at http://www.hca.wa.gov/documents/directions_to_csp.pdf or directions can be obtained by calling (360) 725-1000), on June 23, 2015, at 10:00 a.m.
Date of Intended Adoption: Not sooner than June 24, 2015.
Submit Written Comments to: HCA Rules Coordinator, P.O. Box 45504, Olympia, WA 98504-5504, delivery 626 8th Avenue, Olympia, WA 98504, e-mail arc@hca.wa.gov, fax (360) 586-9727, by 5:00 p.m. on June 23, 2015.
Assistance for Persons with Disabilities: Contact Kelly Richters by June 17, 2015, TTY (800) 848-5429 or (360) 725-1307 or e-mail kelly.richters@hca.wa.gov.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The agency is updating these sections to fix outdated references and improve readability.
Reasons Supporting Proposal: See Purpose above.
Statutory Authority for Adoption: RCW 41.05.021, 41.05.160.
Statute Being Implemented: RCW 41.05.021, 41.05.160.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: HCA, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Sean Sullivan, P.O. Box 42716, Olympia, WA 98504-2716, (360) 725-1344.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The agency has analyzed the proposed rules and concludes they do not impose more than minor costs for affected small businesses.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to HCA rules unless requested by the joint administrative rules review committee or applied voluntarily.
May 18, 2015
Jason R. P. Crabbe
Rules Coordinator
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-101 Purpose and scope.
This section describes the ((medical assistance administration (MAA))) medicaid agency reimbursement rules for free-standing kidney centers providing dialysis and end-stage renal disease services to ((MAA)) agency clients.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-105 Definitions.
The following definitions and those found in chapter 182-500 WAC ((388-500-0005)), apply to this chapter.
(("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 end stage renal disease (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)) uses an automated peritoneal cycler for delivering dialysis.
"Dialysate" means an electrolyte solution((,)) used in dialysis containing elements such as potassium((,)) and sodium chloride((, etc., surrounding)). It surrounds the membrane or fibers and ((allowing)) allows the 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)) For home dialysis, ((the time)) it means the 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)) to eliminate harmful substances((,)) and ((replacing)) replace 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((,)) that is 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)) the agency kidney center services billing instructions.
(("Take home drugs" means outpatient prescription drugs that are administered outside of a provider's office.))
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-120 Provider requirements.
To receive reimbursement from the ((medical assistance administration (MAA))) medicaid agency for providing care to ((MAA)) agency clients, a kidney center must:
(1) Be a medicare-certified end-stage renal disease (ESRD) facility and have a signed core provider agreement with ((MAA)) the agency (see chapter ((388-502)) 182-502 WAC);
(2) Meet requirements found in chapter ((388-502)) 182-502 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.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-130 Covered services.
(1) The ((department)) medicaid agency covers the following services and supplies subject to the restrictions and limitations in this section and other applicable published WAC:
(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 the ((department)) agency. 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 and 388-501-0169)) 182-501-0165 and 182-501-0169).
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-140 Noncovered services.
(1) The ((department)) medicaid agency does not reimburse kidney centers for the following:
(a) Blood and blood products (refer to WAC ((388-540-190)) 182-540-190);
(b) Personal care items such as slippers((,)) and 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)) 182-540-160).
(2) The ((department)) agency evaluates a request for any service listed as noncovered in this chapter under ((the provisions of WAC 388-501-0160)) WAC 182-501-0160.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-150 Reimbursement—General.
(1) Kidney center services described in this section are paid by one of two methods:
(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)) 182-540-160).
(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 ((department)) medicaid agency but not included in the composite rate are billed and paid separately (refer to WAC ((388-540-170)) 182-540-170).
(2) Limitation extension request - The ((department)) agency evaluates billings for covered services that are subject to limitations or other restrictions, and approves ((such)) the services beyond those limitations or restrictions when medically necessary under ((the provisions of WAC 388-501-0165 and 388-501-0169)) WAC 182-501-0165 and 182-501-0169.
(3) Take-home drugs - The ((department)) agency reimburses kidney centers for take-home drugs only when they meet the conditions described in WAC ((388-540-170)) 182-540-170(1). Other drugs for at-home use must be billed by a pharmacy and be subject to the ((department's)) agency's 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 - The ((department)) agency does not reimburse kidney centers as a primary payer for medicare eligible clients.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-160 Items and services included in the composite rate.
(1) The following equipment, supplies, and services for in-facility and home dialysis are included in the composite rate:
(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)) 182-540-180);
(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))) medicaid agency issues a composite rate payment only when all ((of)) the ((above)) items and services in subsection (1) of this section are furnished or available at each dialysis session.
(3) If the facility fails to furnish or have available any of the ((above)) items((, MAA)) in subsection (1) of this section, the agency does not pay for any part of the items and services that were furnished.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-170 Items and services not included in the composite rate.
The following items and services are not included in the composite rate and must be billed separately, subject to the restrictions or limitations in this section and other applicable published WAC:
(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)) 182-530-7500; 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)) 182-540-190); and
(4) Home dialysis helpers.
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-190 Blood products and services.
(1) The ((medical assistance administration (MAA))) medicaid agency reimburses free-standing kidney centers for:
(a) Blood processing and other fees assessed by nonprofit 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)) The agency does not reimburse centers for blood or blood products (refer to WAC ((388-550-6500)) 182-550-6500).
(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)) 182-540-150 and 182-540-160).
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-200 Epoetin alpha (EPO) therapy.
The ((medical assistance administration (MAA))) medicaid agency reimburses the kidney center for EPO therapy when:
(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;
(b) Continuing EPO therapy with a hematocrit between thirty and thirty-six percent; or
(c) Medical justification documented in the client's record is required for hematocrits ((greater)) more than thirty-six or ((hemaglobins greater then)) hemoglobins more than twelve. Medical justification includes:
(i) Documentation that the dose is being titrated downward to bring a patient's hematocrit back within target range; or
(ii) Documentation that it is medically necessary for the client to have a target hematocrit ((greater)) more than thirty-six percent.
(2) Provided to a home dialysis client:
(a) Under the same hematocrit((/)) and 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.)
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-540-210 Injectable drugs given in the kidney center.
Injectable drugs administered in the kidney center are reimbursed up to the ((medical assistance administration's (MAA))) medicaid agency published maximum fees.
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