No. 40490 (Change in Proposed Rule): Rule R414-10A. Transplant Services Standards

DAR File No.: 40490
Filed: 10/12/2016 09:20:58 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This change is based on comments the Department received after filing this rule for public comment in June 2016.

Summary of the rule or change:

This amendment clarifies some definitions in the text. It further clarifies provisions for psycho-social evaluations, clarifies stem cell transplantation services, reinstates search coverage for donors, removes address information for the Prior Authorization Unit, clarifies non-covered services for solid organ transplantation, and makes other technical changes. (Editor's Note: The original proposed repeal and reenactment upon which this change in proposed rule (CPR) was based was published in the July 1, 2016, issue of the Utah State Bulletin, on page 105. Underlining in the rule below indicates text that has been added since the publication of the proposed rule mentioned above; strike-out indicates text that has been deleted. You must view the CPR and the proposed repeal and reenactment together to understand all of the changes that will be enforceable should the agency make this rule effective.)

Statutory or constitutional authorization for this rule:

• 42 CFR 482.68
• Section 26-1-5
• Section 26-18-3

Anticipated cost or savings to:

the state budget:

There is no impact to the state budget because transplant services for Medicaid recipients remain unaffected by this change.

local governments:

There is no impact to local governments because they do not fund or provide transplant services to Medicaid recipients.

small businesses:

There is no impact to small businesses because transplant services for Medicaid recipients remain unaffected by this change.

persons other than small businesses, businesses, or local governmental entities:

There is no impact to Medicaid providers and to Medicaid recipients because transplant services remain unaffected by this change.

Compliance costs for affected persons:

There are no compliance costs to a single Medicaid provider or to a Medicaid recipient because transplant services remain unaffected by this change.

Comments by the department head on the fiscal impact the rule may have on businesses:

There is no fiscal impact to business because the changes do not affect the services provided in accordance with this rule.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Health Care Financing, Coverage and Reimbursement Policy
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Craig Devashrayee at the above address, by phone at 801-538-6641, by FAX at 801-538-6099, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/01/2016

This rule may become effective on:

12/08/2016

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

R414. Health, Health Care Financing, Coverage and Reimbursement Policy.

R414-10A. Transplant Services Standards.

R414-10A-1. Introduction and Authority.

(1) This rule establishes standards and requirements for tissue and organ transplantation services for the State of Utah Medicaid Program.

(2) Title XIX of the Social Security Act allows coverage of transplantation services when there is no discrimination in the availability of services and high quality care is available to all eligible individuals.

(3) Section 26-18-2.3 grants the Department of Health discretion to fund transplantation services.

 

R414-10A-2. Definitions.

For purposes of Rule R414-10A:

(1) "Abstinence" means the documented non-use of any abusable [psychoactive ]substance by the patient.

(2) "Abusable substance" means any substance which is not appropriately prescribed and taken under the direction of a physician or is not medically indicated. This includes, but is not limited to, over-the-counter medicines, prescription medicines, alcohol, tobacco (including nicotine-bearing vapor products), cannabis, benzodiazepines, narcotics, methadone, cocaine, amphetamines, opiates, tricyclic antidepressants, barbiturates, and street drugs.

(3) "Active infection" means current presumptive evidence of invasion of tissue or body fluids by bacteria, viruses, fungi, rickettsiae, or parasites which is not demonstrated to be effectively controlled by the host, antibiotic or antimicrobial agents.

(4) "Active substance use" means the current use (within the most recent six months) of any abusable substance or substances that can adversely impact treatment outcomes or treatment plan adherence. This may include the personal admission of substance use with a positive drug screen.

(5) "Allogenic" means having a different genetic constitution but belonging to the same species.

(6) "Autologous" means the products or components of the same individual person.

(7) "Department" means the Utah Department of Health.

(8) "Drug screen" means testing to identify the presence of one or more drugs or substances as stated in Subsection R414-10A-2(2), [that]which can adversely impact treatment outcomes or treatment plan adherence[and which include, but are not limited to, tobacco (or any nicotine-delivery system, e.g. vapor products), cannabis, alcohol, benzodiazepines, narcotics, methadone, cocaine, amphetamines, opiates, tricyclic antidepressants, and barbiturates].

(9) "Emergency transplantation" means any transplantation which for reasons of medical necessity requires that a transplant be performed less than five days after determination of the need for the procedure.

(10) "Hematopoietic stem cell transplantation and bone marrow transplantation" means transplantation of cells from the bone marrow stem cells, peripheral blood stem cells, or cord blood stem cells to supplant the patient's bone marrow.

(11) "Intestine transplantation" means transplantation of the small bowel or both the small bowel and colon.

(12) "Medical necessity", for purposes of this rule, means a patient's medical condition that meets all the requirements and none of the contraindications for the type of transplantation requested.

(13) "Multi-organ transplantations" means, except for corneas, the transplantation of more than one tissue or organ during the same operative procedure.

(14) "Medicare-approved transplant center" means a center that meets Medicare's conditions of participation for transplant hospitals or, for purposes of this rule, is an approved National Marrow Donor Program (NMDP) bone marrow transplant center.

(15) "Patient" means an individual eligible to receive covered Medicaid services from an enrolled Medicaid provider and is receiving covered professional services provided or directed by a licensed practitioner of the healing arts enrolled as a Medicaid provider.

(16) "Remission" means the lack of any evidence of the cancer on physical examination and hematological evaluation, including normocellular bone marrow with less than five percent blast cells, and peripheral blood counts within normal values, except for patients who are receiving maintenance chemotherapy.

(17) "Services" means the type of medical assistance specified in Subsections 1905(a)(1) through (24) of the Social Security Act and interpreted in 42 CFR 440, Subpart A.

(18) "Substance use [disorder rehabilitation]treatment program" means a [rehabilitation]treatment program developed and conducted by an inpatient or outpatient facility that, at a minimum, meets the standards of organization and staff of a chemical dependency and substance use disorder specialty facility specified in Section R432-10[2]1-4 and Rule R501-21.

(19) "Transplantation" means the transfer of a human organ or tissue from one person to another or from one site to another in the same individual, excluding skin, tendon, and bone.

 

R414-10A-3. Patient Eligibility Requirements for Coverage of Transplantation Services.

Transplantation services are available to categorically eligible and medically needy individuals who are Title XIX eligible and meet the requirements in this rule at the time the transplantation service is provided.

 

R414-10A-4. Program Access Requirements.

(1) Transplantation services may be provided only for eligible patients who meet the requirements in this rule and only for services covered under the Utah Medicaid program.

(2) Transplantation services may be provided only in a Medicare-approved transplant center.

(3) Transplantation services may be provided out-of-state in a Medicare-approved facility only when the service is not available in an approved facility in the state of Utah.

(4) All Utah transplant requirements and policies are applicable to in-state and out-of-state transplant services and facilities.

 

R414-10A-5. Service Coverage.

(1) Transplantation services are covered by the Utah Medicaid program only when requirements in this rule are met.

(2) Multi-organ transplantation services may be provided only when the requirements for each individual transplant are met.

(3) Repeat transplantations of the same tissues or organs may be covered only under Departmental review and approval based on requirements in this rule.

(4) The following transplants are covered when requirements in this rule are met:

(a) Cornea, heart, lung, kidney, liver, pancreas, intestine, bone marrow, hematopoietic stem cell.

(b) Some combinations of the above may also qualify.

(5) Emergency transplantations may be covered if all requirements are met.

 

R414-10A-6. Prior Authorization.

(1) Prior authorization (PA) may be required for any transplantation service.

(a) To determine if PA is required, refer to the Utah Medicaid Coverage and Reimbursement Code Lookup tool.

(2) The Department's evidence-based criteria may be used, when available, as part of the PA process.

(3) If PA is required, the request must include documentation that the patient meets the organ specific requirements in this rule.

(4) The PA request for transplantation services must include:

(a) A [D]description of condition needing transplantation[.];

(b) Transplantation treatment alternatives utilized previous to the transplant request[.];

(c) Transplantation treatment alternatives considered and discarded, including rationale for discarding[.];

(d) A comprehensive examination, evaluation and recommendation[s] completed by a Board-Certified or Board-Eligible [(BC/BE) ]specialist and medical and surgical specialists in the field directly related to the patient's condition , which demonstrates the need for a transplant. [needing the transplant. This must include the patient's need for and ability]The patient must also demonstrate the ability to tolerate the proposed transplant and subsequent treatment regimen[.];

(e) A comprehensive psycho-social evaluation of the patient [which must]that include s:[the patient's motivation for transplant and ability to follow long-term treatment and follow-up regimen.]

i. motivation for transplant;

ii. willingness and ability to follow a long-term treatment and follow-up regimen; and

iii. history of active substance use.

(f) If the patient is less than 18 years of age, [A]a comprehensive psycho-social evaluation of the patient's parent or guardian[, if the patient is less than 18 years of age. This evaluation must] that includes:[the parents and patient's motivation (age appropriate) for transplant, substance use history, compliance, and ability to follow long-term treatment and follow-up regimen.]

i. motivation for transplant;

ii. willingness and ability to follow a long-term treatment and follow-up regimen; and

iii. history of active substance use.

(g) A comprehensive psychiatric evaluation, if the patient has a history of mental illness.

(h) Documentation of a successfully completed treatment program or abstinence, if the patient has a history of substance use.

(i) Treatment program success and abstinence are supported by negative drug screens for a minimum of six months, with two negative drug screens in the most recent three months. The timing of the drug screens is in relation to the PA request date.

(j) If the history of substance use involves drugs other than those listed in this rule under Section R414-10A-2, then the drug screens must include the other substance upon drug testing availability.

(k) The patient may not be an active substance user as defined under Section R414-10A-2.

(l) Comprehensive infectious disease evaluation for a patient with a recent or current suspected infectious episode.

(m) All applicable hospital and clinic records.

(n) Completed cancer screening tests.

(o) All relevant laboratory and imaging studies.

(p) Documentation that the patient meets the eligibility and selection criteria for the transplant facility where the transplant will be performed.

(q) Any other documentation requested by PA or the Department's physician consultants.[

(5) Submit this documentation, with a completed request for authorization form, to the Division of Medicaid and Health Financing

Medicaid Prior Authorization Unit

P. O. Box 143111

Salt Lake City, UT 84114-3111]

([6]5) If incomplete documentation is received by the Department, the patient's case is pended until the requested documentation has been received.

([7]6) If a transplant requiring PA is performed without PA, reimbursement may be denied for all services related to the transplant up to the outlier threshold days for the specific type of transplant.

([8]7) Refer to the Section I: General Information Provider Manual for retroactive authorization for emergency transplant services.

 

R414-10A-7. Solid Organ Transplantation, Covered Services and Requirements.

(1) The following solid organ transplant services are covered. Minimum requirements for specific transplant services are shown. As required by 42 CFR 482, Subpart E, each transplant center must also have written selection criteria.

(2) All patients must be free of active infection. Liver transplants are excepted as noted.

(3) Liver.

(a) The patient must:

(i) have progressive, irreversible liver disease requiring transplant;

(ii) be free from active infection outside the hepatobiliary system;

(iii) not have acute, severe hemodynamic compromise at the time of transplantation if this compromises non-hepatic end-organs;

(iv) be free from significant pulmonary disease;

(v) be free from any significant cardiovascular disease; and

(vi) not have stage IV hepatic coma.

(4) Cornea.

(a) The patient must be free of other associated disease that may preclude visual improvement with transplant.

(5) Cardiac.

(a) The patient must:

(i) have irreversible and progressive cardiac disease with a life expectancy of one year or less without transplant or progressive pulmonary hypertension without other treatment options; and

(ii) be free from significant pulmonary disease, except pulmonary hypertension.

(6) Intestine.

(a) The patient must:

(i) have short bowel syndrome or irreversible and progressive small bowel disease requiring daily hyperalimentation without reasonable alternatives;

(ii) be free from significant pulmonary disease; and

(iii) be free from significant cardiovascular disease.

(7) Kidney.

(a) The patient must:

(i) have irreversible, progressive end-stage renal disease;

(ii) not have acute, severe hemodynamic compromise at the time of transplantation if this compromises non-renal end-organs;

(iii) be free from significant pulmonary disease; and

(iv) be free from any significant cardiovascular disease.

(8) Lung.

(a) The patient must:

(i) not have acute, severe hemodynamic compromise at the time of the transplantation if this compromises non-pulmonary end-organs;

(ii) be free from significant cardiovascular disease; and

(iii) demonstrate abstinence from tobacco use within the last 6 months.

(9) Pancreas.

(a) The patient must:

(i) have type I diabetes mellitus;

(ii) not have acute, severe hemodynamic compromise at the time of the transplantation if this compromises end-organs;

(iii) not have active peptic ulcer disease;

(iv) be free from significant cardiovascular disease; and

(v) be free from significant pulmonary disease.

(10) Multi-organ transplants.

(a) Kidney/pancreas, liver/kidney, cardiac/lung, intestine/liver, and other multi-organ transplants may be considered;

(i) each case is reviewed individually as to medical necessity and appropriateness; and

(ii) complete documentation, including justification and outcomes, must be provided.

 

R414-10A-8. Solid Organ Transplantation, Non-Covered Services.

(1) Transplants requiring prior authorization performed without prior authorization. (Refer to the Section I: General Information Provider Manual for request for retroactive authorization for emergency transplant services.)

(2) Transplant for patients who did not qualify for Medicaid benefits at the time of transplantation. (Retroactive Medicaid qualification may be an exception.)

(3) Transplants which are experimental or investigational in nature.

(4) Transplant of beta cells or other pancreas cells not part of a pancreatic organ transplantation.

(5) Transplant of cells or tissues into the coronary arteries, myocardium, central nervous system, or spinal cord.

(6) "Bridge-to-transplant" devices for heart transplant:

(a) Temporary or implanted ventricular assist devices with the exception of intra-aortic balloon assist devices;

(b) Temporary or implanted biventricular assist devices; or

(c) Temporary or implanted mechanical heart.

(7) Transplants to patients with:

(a) Malignant neoplasm with a high risk for reoccurrence and non-curable malignancy (excluding localized skin cancer).

(b) Chronic illness with one year or less life expectancy.

(c) Limited, irreversible rehabilitation potential.

(8) [Payment for organ preparation or procurement.

(9) ]All other conditions not specifically listed as covered in the rule.

 

R414-10A-9. Hematopoietic Stem Cell Transplantation (HSCT), Covered Services and Requirements.

(1) [HSCT]Allogeneic and syngeneic hematopoietic stem cell transplantation may be approved only when the patient has a suitable HLA-matched donor and one of the covered conditions is present.

(a) A search of related family members, unrelated persons, or both to find a suitable donor is a covered service.

(2) Patient must have adequate marrow and lack of marrow involvement of primary malignancy if autologous transplant.

(3) Patient must be free from any active infection.

(4) Allogeneic Hematopoietic Stem Cell Transplantation (ASCT) is covered for:

(a) Leukemia, leukemia in remission, or aplastic anemia; or

(b) Severe Combined Immunodeficiency Disease (SCID) and for the treatment of Wiskott-Aldrich syndrome.

(5) Autologous Hematopoietic Stem Cell Transplantation (AuSCT) is covered for:

(a) Acute leukemia in remission with a high probability of relapse and has no Human Leucocyte Antigens (HLA)-matched;

(b) Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following an initial response;

(c) Recurrent or refractory neuroblastoma; and

(d) Advanced Hodgkin's disease with failed conventional therapy and has no HLA-matched donor.

(e) Single AuSCT is only covered for Durie-Salmon Stage II or III that fit the following requirements:

(i) Newly diagnosed or responsive multiple myeloma. This includes those patients with previously untreated disease, those with at least a partial response to prior chemotherapy (defined as a 50 percent decrease either in measurable paraprotein (serum, urine or both) or in bone marrow infiltration, sustained for at least one month), and those in responsive relapse; and

(ii) adequate cardiac, renal, pulmonary, and hepatic function.

(f) When recognized clinical risk factors are employed to select patients for transplantation, High Dose Melphalan (HDM) together with AuSCT is medically reasonable and necessary for any age group with primary Amyloid Light (AL) chain amyloidosis who meet the following criteria:

(i) Amyloid deposition in two or fewer organs; and

(ii) Cardiac left ventricular Ejection Fraction (EF) greater than 45 percent.

 

R414-10A-10. HSCT Transplantation, Non-Covered Services.

(1) HSCT is not covered as treatment for multiple myeloma.

(2) AuSCT is not covered for:

(a) Acute leukemia not in remission;

(b) Chronic granulocytic leukemia;

(c) Solid tumors (other than neuroblastoma);

(d) Tandem transplantation (multiple rounds of AuSCT) for patients with multiple myeloma;

(e) Non-primary AL amyloidosis; or

(f) Primary AL amyloidosis for patients who are at least 64 years of age.

(3) All other conditions not specifically listed as covered in this rule.

 

R414-10A-11. Requests for Non-Covered Transplantation Services.

Requests for non-covered services are considered based on evidence submitted as to the efficacy of the requested services. These requests are reviewed on a case -[ ]by -[ ]case basis and require Medicaid Director or designee approval. Evidence types may include, but are not limited to:

(1) Evidence published in peer-reviewed medical journals listed on the Centers for Medicare and Medicaid Services (CMS) website.

(2) Evidence of acceptable survival rates with the proposed protocol in groups with similar clinical characteristics to the patient:

(a) The current survival rate threshold is at least 75 percent one-year survival and at least 55 percent three-year survival; or

(b) Similar characteristics include age, tumor type, tumor size, resection status, presence of metastases, etc.

(3) Study size with sufficient number of individuals for statistical analysis; or

(4) Evidence that the proposed protocol is a less costly alternative to other potential treatment protocols.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: 2016

Notice of Continuation: January 24, 2012

Authorizing, and Implemented or Interpreted Law: 26-1-5; 26-18-3