SOCIAL AND HEALTH SERVICES
(Medical Assistance Administration)
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, 388-531-0250, 388-531-0650, 388-531-1600, 388-550-2800, and 388-550-4400.
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 medical necessity criteria and pre- and postoperative requirements for clients that would further prevent the likelihood of complications.
This continues the emergency rule that is currently in effect under WSR 04-23-054 while MAA completes the permanent rule-making process begun under WSR 04-12-093. MAA anticipates filing the permanent rule proposal (CR-102 notice) in June 2005.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.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 7, 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 7, Repealed 0.
Date Adopted: March 7, 2005.
Andy Fernando, Manager
Rules and Policies Assistance Unit3438.7
(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.]
(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:
(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;
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.]
(a) Advanced registered nurse practitioners (ARNP);
(b) Federally qualified health centers (FQHCs);
(c) Health departments;
(d) Hospitals currently licensed by the department of health;
(e) Independent (outside) laboratories CLIA certified to perform tests. See WAC 388-531-0800;
(f) Licensed radiology facilities;
(g) Medicare-certified ambulatory surgery centers;
(h) Medicare-certified rural health clinics;
(i) Providers who have a signed agreement with MAA to provide screening services to eligible persons in the EPSDT program;
(j) Registered nurse first assistants (RNFA); and
(k) Persons currently licensed by the state of Washington department of health to practice any of the following:
(i) Dentistry (refer to chapter 388-535 WAC);
(ii) Medicine and osteopathy;
(iv) Optometry; or
(2) MAA does not reimburse for services performed by any of the following practitioners:
(b) Christian Science practitioners or theological healers;
(f) Massage therapists as licensed by the Washington state department of health;
(i) Those who have a master's degree in social work (MSW), except those employed by an FQHC or who have prior authorization to evaluate a client for bariatric surgery;
(j) Any other licensed or unlicensed practitioners not otherwise specifically provided for in WAC 388-502-0010; or
(k) Any other licensed practitioners providing services which the practitioner is not:
(i) Licensed to provide; and
(ii) Trained to provide.
(3) MAA reimburses practitioners listed in subsection (2) of this section for physician-related services if those services are mandated by, and provided to, clients who are eligible for one of the following:
(a) The EPSDT program;
(b) A Medicaid program for qualified Medicare beneficiaries (QMB); or
(c) A waiver program.
[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0250, filed 12/6/00, effective 1/6/01.]
(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
(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.]
(2) Bariatric Surgery must be performed in a hospital with a bariatric surgery program, and the hospital must be:
(a) Located in the state of Washington or approved border cities (see WAC 388-501-0175); and
(b) Meet the requirements of WAC 388-550-2301.
(3) 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.
(4) MAA authorizes payment for bariatric surgery and bariatric surgery-related services in three stages:
(a) Stage one - initial assessment of client;
(b) Stage two - evaluations for bariatric surgery and successful completion of a weight loss regimen; and
(c) Stage three - bariatric surgery.
Stage one - initial assessment
(5) 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 (6) of this section.
(6) The client meets the preliminary conditions of stage one when:
(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 not pregnant. (Pregnancy within the first two years following bariatric surgery is not recommended. When applicable, a Family Planning consultation is highly recommended prior to bariatric surgery.);
(d) 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 bariatric surgery is medically necessary and that the benefits of bariatric surgery outweigh the risk of surgical mortality; and
(e) 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 from bariatric surgery.
(7) If a client meets the criteria in subsection (6) 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 (5) and (6) of this section.
(8) MAA evaluates requests 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 for covered services in WAC 388-501-0165.
Stage two - evaluations for bariatric surgery and successful completion of a weight loss regimen
(9) 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 postsurgical lifestyle changes; and
(B) If applicable, 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 and/or alcohol abuse and has been drug and/or alcohol 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 (13) 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 weight loss regimen (refer to WAC 388-531-1600 (9)(d)(ii)).
(d) Under the supervision of a licensed medical provider, the client must participate in a weight loss regimen prior to surgery. The client must, within one hundred and eighty days from the date of MAA's stage one authorization, lose at least five percent of his or her initial body weight. If the client does not meet this weight loss requirement within one hundred and eighty days from the date of MAA's authorization, MAA will cancel the authorization. The client or the client's provider must reapply for prior authorization from MAA to restart stage two. For the purpose of this section, "initial body weight" means the client's weight at the first evaluation appointment.
(i) The purpose of the weight loss regimen is to help the client achieve the required five percent loss of initial body weight prior to surgery and 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 weight loss regimen 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 bariatric surgery if the stage two requirements were successfully completed.
(A) The provider must document the client's compliance in keeping scheduled appointments and the client's progress toward weight loss by serial weight recordings. Clients must lose at least five percent loss of initial body weight and must maintain the five percent weight loss until surgery;
(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 weight loss progress;
(D) The client must keep a journal of active participation in the medically structured weight loss regimen including the activities under (d)(iii)(A), (d)(iii)(B) if appropriate, and (d)(iii)(C) of this subsection.
(10) If the client fails to complete all of the requirements of subsection (9) of this section, MAA will not authorize stage three - bariatric surgery.
(11) If the client is unable to meet all of the stage two criteria, the client or the client's provider must reapply for prior authorization from MAA to re-enter stage two.
Stage three - bariatric surgery
(12) 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.
(13) 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.
(14) 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.]3525.2
|Diagnoses related group (DRG) negotiated conversion factor||Hospitals participating in the Medicaid hospital selective contracting program under waiver from the federal government|
|DRG cost-based conversion factor||Hospitals not participating in or exempt from the Medicaid hospital selective contracting program|
|Ratio of costs-to-charges (RCC)||Hospitals or services exempt from DRG payment methods|
|Single case rate||Bariatric surgery|
|Fixed per diem rate||Acute physical medicine and rehabilitation (Acute PM&R) Level B facilities and long-term acute care (LTAC) hospitals|
|Cost settlement||MAA-approved critical access hospitals (CAHS)|
(2) The department's annual aggregate Medicaid payments to each hospital for inpatient hospital services provided to Medicaid clients will not exceed the hospital's usual and customary charges to the general public for the services (42 CFR § 447.271). The department recoups annual aggregate Medicaid payments that are in excess of the usual and customary charges.
(3) The department's annual aggregate payments for inpatient hospital services, including state-operated hospitals, will not exceed the estimated amounts that the department would have paid using Medicare payment principles.
(4) When hospital ownership changes, the department's payment to the hospital will not exceed the amount allowed under 42 U.S.C. Section 1395x (v)(1)(O).
(5) Hospitals participating in the medical assistance program must annually submit to the medical assistance administration:
(a) A copy of the hospital's HCFA 2552 Medicare Cost Report; and
(b) A disproportionate share hospital application.
(6) Reports referred to in subsection (5) of this section must be completed according to:
(a) Medicare's cost reporting requirements;
(b) The provisions of this chapter; and
(c) Instructions issued by MAA.
(7) The department requires hospitals to follow generally accepted accounting principles unless federally or state regulated.
(8) Participating hospitals must permit the department to conduct periodic audits of their financial and statistical records.
(9) The department reimburses hospitals for claims involving clients with third-party liability insurance:
(a) At the lesser of either the DRG:
(i) Billed amount minus the third-party payment amount; or
(ii) Allowed amount minus the third-party payment amount; or
(b) The RCC allowed payment minus the third-party payment amount.
[Statutory Authority: RCW 74.08.090 and 74.09.500. 04-19-113, § 388-550-2800, filed 9/21/04, effective 10/22/04. Statutory Authority: RCW 74.08.090, 74.09.500, 74.09.035(1), and 43.88.290. 02-21-019, § 388-550-2800, filed 10/8/02, effective 11/8/02. Statutory Authority: RCW 74.08.090 and 42 U.S.C. 1395x(v), 42 C.F.R. 447.271, .11303, and .2652. 01-16-142, § 388-550-2800, filed 7/31/01, effective 8/31/01. Statutory Authority: RCW 74.09.090, 42 U.S.C. 1395x(v) and 1396r-4, 42 C.F.R. 447.271, 11303 and 2652. 99-14-027, § 388-550-2800, filed 6/28/99, effective 7/1/99. Statutory Authority: RCW 74.08.090, 42 USC 1395 x(v), 42 CFR 447.271, 447.11303, and 447.2652. 99-06-046, § 388-550-2800, filed 2/26/99, effective 3/29/99. Statutory Authority: RCW 74.08.090, 74.09.730, 74.04.050, 70.01.010, 74.09.200, [74.09.]500, [74.09.]530 and 43.20B.020. 98-01-124, § 388-550-2800, filed 12/18/97, effective 1/18/98.]
(2) Subject to the restrictions and limitations in this section, the department exempts the following services for Medicaid clients from the DRG payment method:
(a) Neonatal services for DRGs 602-619, 621-628, 630, 635, and 637-641.
(b) Acquired immunodeficiency syndrome (AIDS)-related
inpatient services for those cases with a reported diagnosis
of AIDS-related complex and other human immunodeficiency virus
infections. These services are also exempt from the DRG
payment method when funded by the department through the
general assistance programs((
, medically indigent program,))
and any other state-only administered program.
(c) Alcohol or other drug detoxification services when
provided in a hospital having a detoxification provider
agreement with the department to perform these services. These services are also exempt from the DRG payment method
when funded by the department through the general assistance
, medically indigent program,)) and any other
state-only administered program.
(d) Hospital-based intensive inpatient detoxification,
medical stabilization, and drug treatment services provided to
chemically dependent pregnant women (CUP program) by a
certified hospital. These are Medicaid program services and
are not funded by the department through the general
, medically indigent program,)) or any
other state-only administered program.
(e) Acute physical medicine and rehabilitation services
provided in MAA-approved rehabilitation hospitals and hospital
distinct units, and services for physical medicine and
rehabilitation patients. Rehabilitation services provided to
clients under the general assistance programs((
indigent program,)) and any other state-only administered
program are also reimbursed through the RCC payment method.
(f) Psychiatric services provided in nonstate-owned psychiatric hospitals and designated distinct psychiatric units of hospitals.
(g) Chronic pain management treatment provided in department-approved pain treatment facilities.
(h) Administrative day services. The department reimburses administrative days based on the statewide average Medicaid nursing facility per diem rate, which is adjusted annually each November 1. The department applies this rate to patient days identified as administrative days on the hospital's notice of rates. Hospitals must request an administrative day designation on a case-by-case basis.
(i) Inpatient services recorded on a claim that is
grouped by MAA to a DRG for which MAA has not published an all
patient DRG relative weight, except that claims grouped to
DRGs 469 and 470 will be denied payment. This policy also
applies to covered services paid through the general
, medically indigent program,)) and any
other state-only administered program.
(j) Organ transplants that involve the heart, kidney,
liver, lung, allogeneic bone marrow, autologous bone marrow,
or simultaneous kidney/pancreas. These services are also
exempt from the DRG payment method when funded by MAA through
the general assistance programs((
, medically indigent
program,)) and any other state-only administered program.
(k) Bariatric surgery performed in hospitals that meet the criteria in WAC 388-550-2301. MAA pays hospitals for bariatric surgery on a single case rate basis.
(3) Inpatient services provided through a managed care plan contract are reimbursed by the managed care plan.
[Statutory Authority: RCW 74.08.090 and 42 U.S.C. 1395x(v), 42 C.F.R. 447.271, .11303, and .2652. 01-16-142, § 388-550-4400, filed 7/31/01, effective 8/31/01. Statutory Authority: RCW 74.08.090, 74.09.730, 74.04.050, 70.01.010, 74.09.200, [74.09.]500, [74.09.]530 and 43.20B.020. 98-01-124, § 388-550-4400, filed 12/18/97, effective 1/18/98.]3440.4
(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 or approved bordering cities (see WAC 388-501-0175) 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 postsurgery;
(iv) Have an average loss of at least fifty percent of excess body weight achieved by patients at five years postsurgery; and
(v) Have a re-operation or revision rate of five percent or less.
(c) Submit documents to MAA's Division of Medical Management 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(13) 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.