WSR 04-15-090

EMERGENCY RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Medical Assistance Administration)

[ Filed July 16, 2004, 4:25 p.m. , effective July 16, 2004 ]


     

     Purpose: To adopt rules for the reimbursement of bariatric surgery.

     Citation of Existing Rules Affected by this Order: Amending WAC 388-531-0050, 388-531-0150, 388-531-0200, 388-531-0650, and 388-531-1600.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.520.

     Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.

     Reasons for this Finding: Recent studies of gastric bypass surgeries in Washington show an increased likelihood of complications. Specifically for Medical Assistance Administration (MAA) clients following gastric bypass surgery, recent statistics shows a 2.1% in-hospital mortality rate (compared to 0.9% for all other patients in Washington state) and a 3.6% 30-day mortality rate following the surgery (compared to 1.7% for all other Washington state patients). The mortality rates for MAA clients in both instances are more than double that of other patients. The national mortality rate from peer-reviewed literature for gastric bypass surgery is between 0% and 1%.

     Because evidence shows that surgeon experience and competence is one of the most important factors in predicting the likelihood of complications, rules are needed immediately to establish standards for selection of surgeons and hospitals performing gastric bypass surgery for MAA clients. Rules are also needed immediately to establish medical necessity criteria and pre- and post-operative requirements for clients that would further prevent the likelihood of complications.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 1, Amended 5, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 5, Repealed 0.

     Date Adopted: July 14, 2004.

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

3438.3
AMENDATORY SECTION(Amending WSR 03-19-081, filed 9/12/03, effective 10/13/03)

WAC 388-531-0050   Physician-related services definitions.   The following definitions and abbreviations and those found in WAC 388-500-0005, apply to this chapter. Defined words and phrases are bolded the first time they are used in the text.

     "Acquisition cost" means the cost of an item excluding shipping, handling, and any applicable taxes.

     "Acute care" means care provided for clients who are not medically stable. These clients require frequent monitoring by a health care professional in order to maintain their health status. See also WAC 246-335-015.

     "Acute physical medicine and rehabilitation (PM&R)" means a comprehensive inpatient and rehabilitative program coordinated by a multidisciplinary team at an MAA-approved rehabilitation facility. The program provides twenty-four hour specialized nursing services and an intense level of specialized therapy (speech, physical, and occupational) for a diagnostic category for which the client shows significant potential for functional improvement (see WAC 388-550-2501).

     "Add-on procedure(s)" means secondary procedure(s) that are performed in addition to another procedure.

     "Admitting diagnosis" means the medical condition responsible for a hospital admission, as defined by ICD-9-M diagnostic code.

     "Advanced registered nurse practitioner (ARNP)" means a registered nurse prepared in a formal educational program to assume an expanded health services provider role in accordance with WAC 246-840-300 and 246-840-305.

     "Aging and disability services administration (ADSA)" means the administration that administers directly or contracts for long-term care services, including but not limited to nursing facility care and home and community services. See WAC 388-71-0202.

     "Allowed charges" means the maximum amount reimbursed for any procedure that is allowed by MAA.

     "Anesthesia technical advisory group (ATAG)" means an advisory group representing anesthesiologists who are affected by the implementation of the anesthesiology fee schedule.

     "Bariatric surgery" means any surgical procedure, whether open or by laparoscope, which reduces the size of the stomach with or without bypassing a portion of the small intestine and whose primary purpose is the reduction of body weight in an obese individual.

     "Base anesthesia units (BAU)" means a number of anesthesia units assigned to a surgical procedure that includes the usual pre-operative, intra-operative, and post-operative visits. This includes the administration of fluids and/or blood incident to the anesthesia care, and interpretation of noninvasive monitoring by the anesthesiologist.

     "Bundled services" means services integral to the major procedure that are included in the fee for the major procedure. Bundled services are not reimbursed separately.

     "Bundled supplies" means supplies which are considered to be included in the practice expense RVU of the medical or surgical service of which they are an integral part.

     "By report (BR)" means a method of reimbursement in which MAA determines the amount it will pay for a service that is not included in MAA's published fee schedules. MAA may request the provider to submit a "report" describing the nature, extent, time, effort, and/or equipment necessary to deliver the service.

     "Call" means a face-to-face encounter between the client and the provider resulting in the provision of services to the client.

     "Cast material maximum allowable fee" means a reimbursement amount based on the average cost among suppliers for one roll of cast material.

     "Centers for Medicare and Medicaid Services (CMS)" means the agency within the federal Department of Health and Human Services (DHHS) with oversight responsibility for Medicare and Medicaid programs.

     "Certified registered nurse anesthetist (CRNA)" means an advanced registered nurse practitioner (ARNP) with formal training in anesthesia who meets all state and national criteria for certification. The American Association of Nurse Anesthetists specifies the National Certification and scope of practice.

     "Children's health insurance plan (CHIP)," see chapter 388-542 WAC.

     "Clinical Laboratory Improvement Amendment (CLIA)" means regulations from the U.S. Department of Health and Human Services that require all laboratory testing sites to have either a CLIA registration or a CLIA certificate of waiver in order to legally perform testing anywhere in the U.S.

     "Conversion factors" means dollar amounts MAA uses to calculate the maximum allowable fee for physician-related services.

     "Covered service" means a service that is within the scope of the eligible client's medical care program, subject to the limitations in this chapter and other published WAC.

     "CPT," see "current procedural terminology."

     "Critical care services" means physician services for the care of critically ill or injured clients. A critical illness or injury acutely impairs one or more vital organ systems such that the client's survival is jeopardized. Critical care is given in a critical care area, such as the coronary care unit, intensive care unit, respiratory care unit, or the emergency care facility.

     "Current procedural terminology (CPT)" means a systematic listing of descriptive terms and identifying codes for reporting medical services, procedures, and interventions performed by physicians and other practitioners who provide physician-related services. CPT is copyrighted and published annually by the American Medical Association (AMA).

     "Diagnosis code" means a set of numeric or alphanumeric characters assigned by the ICD-9-CM, or successor document, as a shorthand symbol to represent the nature of a disease.

     "Emergency medical condition(s)" means a medical condition(s) that manifests itself by acute symptoms of sufficient severity so that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part.

     "Emergency services" means medical services required by and provided to a patient experiencing an emergency medical condition.

     "Estimated acquisition cost (EAC)" means the department's best estimate of the price providers generally and currently pay for drugs and supplies.

     "Evaluation and management (E&M) codes" means procedure codes which categorize physician services by type of service, place of service, and patient status.

     "Expedited prior authorization" means the process of obtaining authorization that must be used for selected services, in which providers use a set of numeric codes to indicate to MAA which acceptable indications, conditions, diagnoses, and/or criteria are applicable to a particular request for services.

     "Experimental" means a term to describe a procedure, or course of treatment, which lacks sufficient scientific evidence of safety and effectiveness. See WAC 388-531-0550. A service is not "experimental" if the service:

     (1) Is generally accepted by the medical profession as effective and appropriate; and

     (2) Has been approved by the FDA or other requisite government body, if such approval is required.

     "Fee-for-service" means the general payment method MAA uses to reimburse providers for covered medical services provided to medical assistance clients when those services are not covered under MAA's healthy options program or children's health insurance program (CHIP) programs.

     "Flat fee" means the maximum allowable fee established by MAA for a service or item that does not have a relative value unit (RVU) or has an RVU that is not appropriate.

     "Geographic practice cost index (GPCI)" as defined by Medicare, means a Medicare adjustment factor that includes local geographic area estimates of how hard the provider has to work (work effort), what the practice expenses are, and what malpractice costs are. The GPCI reflects one-fourth the difference between the area average and the national average.

     "Global surgery reimbursement," see WAC 388-531-1700.

     "HCPCS Level II" means a coding system established by CMS (formerly known as the Health Care Financing Administration) to define services and procedures not included in CPT.

     "Health care financing administration common procedure coding system (HCPCS)" means the name used for the Centers for Medicare and Medicaid Services (formerly known as the Health Care Financing Administration) codes made up of CPT and HCPCS level II codes.

     "Health care team" means a group of health care providers involved in the care of a client.

     "Hospice" means a medically directed, interdisciplinary program of palliative services which is provided under arrangement with a Title XVIII Washington licensed and certified Washington state hospice for terminally ill clients and the clients' families.

     "ICD-9-CM," see "International Classification of Diseases, 9th Revision, Clinical Modification."

     "Informed consent" means that an individual consents to a procedure after the provider who obtained a properly completed consent form has done all of the following:

     (1) Disclosed and discussed the client's diagnosis; and

     (2) Offered the client an opportunity to ask questions about the procedure and to request information in writing; and

     (3) Given the client a copy of the consent form; and

     (4) Communicated effectively using any language interpretation or special communication device necessary per 42 C.F.R. Chapter IV 441.257; and

     (5) Given the client oral information about all of the following:

     (a) The client's right to not obtain the procedure, including potential risks, benefits, and the consequences of not obtaining the procedure; and

     (b) Alternatives to the procedure including potential risks, benefits, and consequences; and

     (c) The procedure itself, including potential risks, benefits, and consequences.

     "Inpatient hospital admission" means an acute hospital stay for longer than twenty-four hours when the medical care record shows the need for inpatient care beyond twenty-four hours. All admissions are considered inpatient hospital admissions, and are paid as such, regardless of the length of stay, in the following circumstances:

     (1) The death of a client;

     (2) Obstetrical delivery;

     (3) Initial care of a newborn; or

     (4) Transfer to another acute care facility.

     "International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM)" means the systematic listing that transforms verbal descriptions of diseases, injuries, conditions, and procedures into numerical or alphanumerical designations (coding).

     "Investigational" means a term to describe a procedure, or course of treatment, which lacks sufficient scientific evidence of benefit for a particular condition. A service is not "investigational" if the service:

     (1) Is generally accepted by the medical professional as effective and appropriate for the condition in question; or

     (2) Is supported by an overall balance of objective scientific evidence, in which the potential risks and potential benefits are examined, demonstrating the proposed service to be of greater overall benefit to the client in the particular circumstance than another, generally available service.

     "Life support" means mechanical systems, such as ventilators or heart-lung respirators, which are used to supplement or take the place of the normal autonomic functions of a living person.

     "Limitation extension" means a process for requesting and approving reimbursement for covered services whose proposed quantity, frequency, or intensity exceeds that which MAA routinely reimburses. Limitation extensions require prior authorization.

     "Maximum allowable fee" means the maximum dollar amount that MAA will reimburse a provider for specific services, supplies, and equipment.

     "Medically necessary," see WAC 388-500-0005.

     "Medicare physician fee schedule data base (MPFSDB)" means the official HCFA publication of the Medicare policies and RVUs for the RBRVS reimbursement program.

     "Medicare program fee schedule for physician services (MPFSPS)" means the official HCFA publication of the Medicare fees for physician services.

     "Medicare clinical diagnostic laboratory fee schedule" means the fee schedule used by Medicare to reimburse for clinical diagnostic laboratory procedures in the state of Washington.

     "Mentally incompetent" means a client who has been declared mentally incompetent by a federal, state, or local court.

     "Modifier" means a two-digit alphabetic and/or numeric identifier that is added to the procedure code to indicate the type of service performed. The modifier provides the means by which the reporting physician can describe or indicate that a performed service or procedure has been altered by some specific circumstance but not changed in its definition or code. The modifier can affect payment or be used for information only. Modifiers are listed in fee schedules.

     "Outpatient" means a client who is receiving medical services in other than an inpatient hospital setting.

     "Peer-reviewed medical literature" means medical literature published in professional journals that submit articles for review by experts who are not part of the editorial staff. It does not include publications or supplements to publications primarily intended as marketing material for pharmaceutical, medical supplies, medical devices, health service providers, or insurance carriers.

     "Physician care plan" means a written plan of medically necessary treatment that is established by and periodically reviewed and signed by a physician. The plan describes the medically necessary services to be provided by a home health agency, a hospice agency, or a nursing facility.

     "Physician standby" means physician attendance without direct face-to-face client contact and which does not involve provision of care or services.

     "Physician's current procedural terminology," see "CPT, current procedural terminology."

     "PM&R," see acute physical medicine and rehabilitation.

     "Podiatric service" means the diagnosis and medical, surgical, mechanical, manipulative, and electrical treatments of ailments of the foot and ankle.

     "Pound indicator (#)" means a symbol (#) indicating a CPT procedure code listed in MAA fee schedules that is not routinely covered.

     "Preventive" means medical practices that include counseling, anticipatory guidance, risk factor reduction interventions, and the ordering of appropriate laboratory and diagnostic procedures intended to help a client avoid or reduce the risk or incidence of illness or injury.

     "Prior authorization" means a process by which clients or providers must request and receive MAA approval for certain medical services, equipment, or supplies, based on medical necessity, before the services are provided to clients, as a precondition for provider reimbursement. Expedited prior authorization and limitation extension are forms of prior authorization.

     "Professional component" means the part of a procedure or service that relies on the provider's professional skill or training, or the part of that reimbursement that recognizes the provider's cognitive skill.

     "Prognosis" means the probable outcome of a client's illness, including the likelihood of improvement or deterioration in the severity of the illness, the likelihood for recurrence, and the client's probable life span as a result of the illness.

     "Prolonged services" means face-to-face client services furnished by a provider, either in the inpatient or outpatient setting, which involve time beyond what is usual for such services. The time counted toward payment for prolonged E&M services includes only face-to-face contact between the provider and the client, even if the service was not continuous.

     "Provider," see WAC 388-500-0005.

     "Radioallergosorbent test" or "RAST" means a blood test for specific allergies.

     "RBRVS," see resource based relative value scale.

     "RVU," see relative value unit.

     "Reimbursement" means payment to a provider or other MAA-approved entity who bills according to the provisions in WAC 388-502-0100.

     "Reimbursement steering committee (RSC)" means an interagency work group that establishes and maintains RBRVS physician fee schedules and other payment and purchasing systems utilized by the health care authority, MAA, and department of labor and industries.

     "Relative value guide (RVG)" means a system used by the American Society of Anesthesiologists for determining base anesthesia units (BAUs).

     "Relative value unit (RVU)" means a unit which is based on the resources required to perform an individual service or intervention.

     "Resource based relative value scale (RBRVS)" means a scale that measures the relative value of a medical service or intervention, based on the amount of physician resources involved.

     "RBRVS RVU" means a measure of the resources required to perform an individual service or intervention. It is set by Medicare based on three components - physician work, practice cost, and malpractice expense. Practice cost varies depending on the place of service.

     "RSC RVU" means a unit established by the RSC for a procedure that does not have an established RBRVS RVU or has an RBRVS RVU deemed by the RSC as not appropriate for the service.

     "Stat laboratory charges" means charges by a laboratory for performing tests immediately. "Stat" is an abbreviation for the Latin word "statim," meaning immediately.

     "Sterile tray" means a tray containing instruments and supplies needed for certain surgical procedures normally done in an office setting. For reimbursement purposes, tray components are considered by HCFA to be nonroutine and reimbursed separately.

     "Technical advisory group (TAG)" means an advisory group with representatives from professional organizations whose members are affected by implementation of RBRVS physician fee schedules and other payment and purchasing systems utilized by the health care authority, MAA, and department of labor and industries.

     "Technical component" means the part of a procedure or service that relates to the equipment set-up and technician's time, or the part of the procedure and service reimbursement that recognizes the equipment cost and technician time.

[Statutory Authority: RCW 74.04.050, 74.04.057, 74.08.090, and Public Law 104-191. 03-19-081, § 388-531-0050, filed 9/12/03, effective 10/13/03. Statutory Authority: RCW 74.08.090. 03-06-049, § 388-531-0050, filed 2/28/03, effective 3/31/03. Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0050, filed 12/6/00, effective 1/6/01.]


AMENDATORY SECTION(Amending WSR 01-01-012, filed 12/6/00, effective 1/6/01)

WAC 388-531-0150   Noncovered physician-related services -- General and administrative.   (1) Except as provided in WAC 388-531-0100 and subsection (2) of this section, MAA does not cover the following:

     (a) Acupuncture, massage, or massage therapy;

     (b) Any service specifically excluded by statute;

     (c) Care, testing, or treatment of infertility, frigidity, or impotency. This includes procedures for donor ovum, sperm, womb, and reversal of vasectomy or tubal ligation;

     (d) Cosmetic treatment or surgery, except for medically necessary reconstructive surgery to correct defects attributable to trauma, birth defect, or illness;

     (e) Experimental or investigational services, procedures, treatments, devices, drugs, or application of associated services, except when the individual factors of an individual client's condition justify a determination of medical necessity under WAC 388-501-0165;

     (f) Hair transplantation;

     (g) Marital counseling or sex therapy;

     (h) More costly services when MAA determines that less costly, equally effective services are available;

     (i) Vision-related services listed as noncovered in chapter 388-544 WAC;

     (j) Payment for body parts, including organs, tissues, bones and blood, except as allowed in WAC 388-531-1750;

     (k) Physician-supplied medication, except those drugs administered by the physician in the physician's office;

     (l) Physical examinations or routine checkups, except as provided in WAC 388-531-0100;

     (m) Routine foot care. This does not include clients who have a medical condition that affects the feet, such as diabetes or arteriosclerosis obliterans. Routine foot care includes, but is not limited to:

     (i) Treatment of mycotic disease;

     (ii) Removal of warts, corns, or calluses;

     (iii) Trimming of nails and other hygiene care; or

     (iv) Treatment of flat feet;

     (n) Except as provided in WAC 388-531-1600, weight reduction and control services, procedures, treatments, devices, drugs, products, gym memberships, equipment for the purpose of weight reduction, or the application of associated services.

     (o) Nonmedical equipment; and

     (p) Nonemergent admissions and associated services to out-of-state hospitals or noncontracted hospitals in contract areas.

     (2) MAA covers excluded services listed in (1) of this subsection if those services are mandated under and provided to a client who is eligible for one of the following:

     (a) The EPSDT program;

     (b) A Medicaid program for qualified Medicare beneficiaries (QMBs); or

     (c) A waiver program.

[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0150, filed 12/6/00, effective 1/6/01.]


AMENDATORY SECTION(Amending WSR 01-01-012, filed 12/6/00, effective 1/6/01)

WAC 388-531-0200   Physician-related services requiring prior authorization.   (1) MAA requires prior authorization for certain services. Prior authorization includes expedited prior authorization (EPA) and limitation extension (LE). See WAC 388-501-0165.

     (2) The EPA process is designed to eliminate the need for telephone prior authorization for selected admissions and procedures.

     (a) The provider must create an authorization number using the process explained in MAA's physician-related billing instructions.

     (b) Upon request, the provider must provide supporting clinical documentation to MAA showing how the authorization number was created.

     (c) Selected nonemergent admissions to contract hospitals require EPA. These are identified in MAA billing instructions.

     (d) Procedures requiring expedited prior authorization include, but are not limited to, the following:

     (i) Bladder repair;

     (ii) Hysterectomy for clients age forty-five and younger, except with a diagnosis of cancer(s) of the female reproductive system;

     (iii) Outpatient magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA);

     (iv) Reduction mammoplasties/mastectomy for geynecomastia; and

     (v) Strabismus surgery for clients eighteen years of age and older.

     (3) MAA evaluates new technologies under the procedures in WAC 388-531-0550. These require prior authorization.

     (4) Prior authorization is required for the following:

     (a) Abdominoplasty;

     (b) All inpatient hospital stays for acute physical medicine and rehabilitation (PM&R);

     (c) Cochlear implants, which also:

     (i) For coverage, must be performed in an ambulatory surgery center (ASC) or an inpatient or outpatient hospital facility; and

     (ii) For reimbursement, must have the invoice attached to the claim;

     (d) Diagnosis and treatment of eating disorders for clients twenty-one years of age and older;

     (e) Osteopathic manipulative therapy in excess of MAA's published limits;

     (f) Panniculectomy;

     (g) ((Surgical procedures related to weight loss or reduction)) Bariatric surgery (see WAC 388-531-1600); and

     (h) Vagus nerve stimulator insertion, which also:

     (i) For coverage, must be performed in an inpatient or outpatient hospital facility; and

     (ii) For reimbursement, must have the invoice attached to the claim.

     (5) MAA may require a second opinion and/or consultation before authorizing any elective surgical procedure.

     (6) Children six year of age and younger do not require authorization for hospitalization.

[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0200, filed 12/6/00, effective 1/6/01.]


AMENDATORY SECTION(Amending WSR 01-01-012, filed 12/6/00, effective 1/6/01)

WAC 388-531-0650   Hospital physician-related services not requiring authorization when provided in MAA-approved centers of excellence or hospitals authorized to provide the specific services.   MAA covers the following services without prior authorization when provided in MAA-approved centers of excellence. MAA issues periodic publications listing centers of excellence. These services include the following:

     (1) All transplant procedures specified in WAC 388-550-1900;

     (2) Chronic pain management services, including outpatient evaluation and inpatient treatment, as described under WAC 388-550-2400. See also WAC 388-531-0700;

     (3) Sleep studies including but not limited to polysomnograms for clients one year of age and older. MAA allows sleep studies only in outpatient hospital settings as described under WAC 388-550-6350. See also WAC 388-531-1500; and

     (4) Diabetes education, in a DOH-approved facility, per WAC 388-550-6300((; and

     (5) MAA-approved structured weight loss programs. See also WAC 388-531-1600)).

[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0650, filed 12/6/00, effective 1/6/01.]


AMENDATORY SECTION(Amending WSR 01-01-012, filed 12/6/00, effective 1/6/01)

WAC 388-531-1600   ((Structured weight loss physician-related services)) Bariatric surgery.   ((MAA covers structured outpatient weight loss only through an MAA-approved program)) (1) The medical assistance administration (MAA) pays for bariatric surgery for eligible clients when:

     (a) The surgery is medically necessary as defined in WAC 388-500-0005;

     (b) The provisions of this section are met; and

     (c) The surgery is performed in a hospital with a bariatric surgery program, and the hospital:

     (i) Is located in the state of Washington; and

     (ii) Meets the requirements of WAC 388-550-2301.

     (2) If bariatric surgery is requested or prescribed under the EPSDT program, MAA evaluates it as a covered service under EPSDT's standard of coverage that requires the service to be:

     (a) Medically necessary;

     (b) Safe and effective; and

     (c) Not experimental.

     (3) MAA authorizes payment for bariatric surgery and bariatric surgery-related services in three stages:

     (a) Stage one - initial assessment of client;

     (b) Stage two - evaluation for surgery and successful completion of a medically structured diet and exercise program; and

     (c) Stage three - bariatric surgery.

     Stage one - initial assessment

     (4) Any MAA provider who is licensed to practice medicine in the state of Washington may examine a client requesting bariatric surgery to ascertain if the client meets the criteria listed in subsection (5) of this section.

     (5) Bariatric surgery is appropriate when the client meets all of the following criteria:

     (a) The client is between twenty-one and fifty-nine years of age;

     (b) The client has a body mass index (BMI) of thirty-five or greater;

     (c) The client is diagnosed with one of the following:

     (i) Diabetes mellitus;

     (ii) Degenerative joint disease of a major weight bearing joint(s) (the client must be a candidate for joint replacement surgery if weight loss is achieved); or

     (iii) Other rare co-morbid conditions (such as pseudo tumor cerebri) in which there is medical evidence that surgery is medically necessary and that the benefits of surgery outweigh the risk of surgical mortality.

     (d) The client has an absence of other medical conditions such as multiple sclerosis (MS) that would increase the client's risk of surgical mortality or morbidity.

     (6) If a client meets the criteria in subsection (5) of this section, the provider must request prior authorization from MAA before referring the client to stage two of the bariatric surgery authorization process. The provider must attach a medical report to the request for prior authorization with supporting documentation that the client meets the stage one criteria in subsections (4) and (5) of this section.

     Stage two - evaluations and diet/exercise program

     (7) After receiving prior authorization from MAA to begin stage two of the bariatric surgery authorization process, the client must:

     (a) Undergo a comprehensive psychosocial evaluation performed by a psychiatrist, licensed psychiatric ARNP, or licensed independent social worker with a minimum of two years postmasters' experience in a mental health setting. Upon completion, the results of the evaluation must be forwarded to MAA. The comprehensive psychosocial evaluation must include:

     (i) An assessment of the client's mental status or illness to:

     (A) Evaluate the client for the presence of substance abuse problems or psychiatric illness which would preclude the client from participating in presurgical dietary requirements or post-surgical lifestyle changes; or

     (B) Document that the client has been successfully treated for psychiatric illness and has been stabilized for at least six months and/or has been rehabilitated and is free from any drug abuse (e.g., alcoholism, illegal drugs, etc.) and has been drug-free for a period of at least one year.

     (ii) An assessment and certification of the client's ability to comply with the postoperative requirements such as lifelong required dietary changes and regular follow-up.

     (b) Undergo an internal medicine evaluation performed by an internist to assess the client's preoperative condition and mortality risk. Upon completion, the internist must forward the results of the evaluation to MAA.

     (c) Undergo a surgical evaluation by the surgeon who will perform the bariatric surgery (see subsection (11) of this section for surgeon requirements). Upon completion, the surgeon must forward the results of the surgical evaluation to MAA and to the licensed medical provider who is supervising the client's diet and exercise program (refer to WAC 388-531-1600 (7)(d)(ii)).

     (d) Enroll in a medically structured diet and exercise program within one hundred and eighty days after receiving authorization from MAA to begin stage two. If the client does not enroll in a medically structured diet and exercise program within one hundred and eighty days from the date of MAA's initial authorization, MAA will cancel the authorization. The client or the client's provider must reapply for prior authorization from MAA to restart stage two.

     (i) The purpose of the medically structured diet and exercise program is to demonstrate the client's ability to adhere to the radical and lifelong behavior changes and strict diet that are required after bariatric surgery.

     (ii) The medically structured diet and exercise program must:

     (A) Be supervised by a licensed medical provider who has a core provider agreement with MAA;

     (B) Include monthly visits to the medical provider;

     (C) Include counseling twice a month by a registered dietician referred to by the treating provider or surgeon; and

     (D) Be at least six months in duration.

     (iii) Documentation of the following requirements must be retained in the client's medical file. Copies of the documentation must be forwarded to MAA upon completion of stage two. MAA will evaluate the documentation and authorize the client for surgery if the stage two requirements were successfully completed.

     (A) The provider must document the client's compliance in keeping scheduled appointments, the client's progress by serial weight recording, and client's outcome of at least five percent loss of initial body weight;

     (B) For diabetic clients, the provider must document the efforts in diabetic control or stabilization;

     (C) The registered dietician must document the client's compliance (or noncompliance) in keeping scheduled appointments, and the client's progress by regular journal reporting and regular exercise;

     (D) The client must keep a comprehensive journal of active participation in the medically structured diet and exercise program including the activities under (d)(iii)(A), (d)(iii)(B) if appropriate, and (d)(iii)(C) of this subsection.

     (8) If the client fails to complete all of the requirements of subsection (7) of this section, MAA will not authorize stage three - bariatric surgery.

     (9) AA grants authorization for stage two once every twelve months preoperative, per client. If the client does not successfully complete all of the stage two criteria, the client or the client's provider must reapply for prior authorization from MAA to begin stage two.

     Stage three - bariatric surgery

     (10) MAA may withdraw authorization of payment for bariatric surgery at any time up to the actual surgery if MAA determines that the client is not complying with the requirements of this section.

     (11) A surgeon who performs bariatric surgery for medical assistance clients must:

     (a) Have a signed core provider agreement with MAA;

     (b) Have a valid medical license in the state of Washington; and

     (c) Be affiliated with a bariatric surgery program that meets the requirements of WAC 388-550-2301.

     (12) For hospital requirements for stage three-bariatric surgery, see WAC 388-530-2301.

[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-1600, filed 12/6/00, effective 1/6/01.]

3440.2
NEW SECTION
WAC 388-550-2301   Hospital and medical criteria requirements for bariatric surgery.   (1) The medical assistance administration (MAA) pays a hospital for bariatric surgery and bariatric surgery-related services only when:

     (a) The client qualifies for bariatric surgery by successfully completing all requirements under WAC 388-531-1600;

     (b) The client continues to meet the criteria to qualify for bariatric surgery under WAC 388-531-1600 up to the actual surgery date; and

     (c) The hospital providing the bariatric surgery and bariatric surgery-related services meets the requirements in this section and other applicable WAC.

     (2) A hospital must meet the following requirements in order to be reimbursed for bariatric surgery and bariatric surgery-related services provided to an eligible medical assistance client. The hospital must:

     (a) Be located in Washington state and have a current core provider agreement with MAA.

     (b) Have an established bariatric surgery program in operation under which at least one hundred bariatric surgery procedures have been performed. The program must have been in operation for at least five years and be under the direction of an experienced board-certified surgeon. In addition, MAA requires the bariatric surgery program to:

     (i) Have a mortality rate of two percent or less;

     (ii) Have a morbidity rate of fifteen percent or less;

     (iii) Document patient follow-up for at least five years post surgery;

     (iv) Have an average weight loss of fifty percent or more achieved by patients at five years post surgery; and

     (v) Have a re-operation or revision rate of five percent or less.

     (c) Submit documents to MAA that verify the performance requirements listed in this section. The hospital must receive approval from MAA prior to performing a bariatric surgery for a medical assistance client.

     (3) MAA waives the program requirements listed in subsection (2)(b) of this section if the hospital participates in a statewide bariatric surgery quality assurance program such as the Clinical Outcomes Assessment Program (COAP).

     (4) See WAC 388-531-1600(11) for requirements for surgeons who perform bariatric surgery.

     (5) Authorization does not guarantee payment. Authorization for bariatric surgery and bariatric surgery-related services is valid only if:

     (a) The client is eligible on the date of service; and

     (b) The provider meets the criteria in this section and other applicable WAC to perform bariatric surgery and/or to provide bariatric surgery-related services.

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