WSR 04-23-054

EMERGENCY RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Medical Assistance Administration)

[ Filed November 12, 2004, 4:08 p.m. , effective November 12, 2004 ]


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

Citation of Existing Rules Affected by this Order: Amending WAC 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% thirty-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 medial necessity criteria and pre- and post-operative requirements for clients that would further prevent the likelihood of complications.

This continues the emergency rule that is currently in effect under WSR 04-15-090 while MAA completes the permanent rule-making process begun under WSR 04-12-093. MAA anticipates filing the permanent rule proposal (CR-102) in December 2004.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.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 4, 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 4, Repealed 0.

Date Adopted: November 9, 2004.

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

3438.5
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) MAA 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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