BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the amendment of ARM 37.86.4701, 37.86.4705, and 37.86.4706 pertaining to Medicaid covered organ and tissue transplantation

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT

 

TO:  All Concerned Persons

 

            1.  On September 3, 2009 at 10:30 a.m., the Department of Public Health and Human Services will hold a public hearing in Room 207 of 111 North Sanders at Helena, Montana, to consider the proposed amendment of the above-stated rules.

 

            2.  The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice.  If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on August 24, 2009, to advise us of the nature of the accommodation that you need.  Please contact Rhonda Lesofski, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

                3.  The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

            37.86.4701  ORGAN TRANSPLANTATION, DEFINITIONS  (1)  "Organ transplantation" means the implantation of a living (viable) functioning functional human organ or organ system including bone marrow for the purpose of maintaining all or a major part of that organ function in the recipient.

            (2)  "Tissue transplantation" means the implantation of functional, human tissue.  For purpose of the transplantation rules, tissue transplants include only corneal, bone marrow, and peripheral stem cell transplants.

            (2) (3)  Organ and tissue transplantation includes the transplant surgery and those activities directly related to the transplantation.  These activities must be performed at a transplant facility if required by Medicare.  These activities may include:

            (a)  evaluation of the patient as a potential transplant candidate;

            (b)  pre-transplant preparation including histo-compatibility testing procedures;

            (c)  post surgical hospitalization;

            (d)  outpatient care, including Federal Drug Administration (FDA) approved medications deemed necessary for mainte­nance or because of resulting complications.

            (3)  "Transplant facility" means a medical facility which:

            (a)  has received medicare certification as a transplant facility, unless medicare does not certify facilities to perform transplants of a particular organ or system; and

            (b)  participates in the Montana Medicaid program.

 

            AUTH:  53-2-201, 53-6-113, MCA

            IMP:  53-2-201, 53-6-101, 53-6-141, MCA

 

            37.86.4705  ORGAN TRANSPLANTATION, REQUIREMENTS  (1)  This rule provides the requirements for mMedicaid coverage of organ and tissue transplantations.  The requirements in this rule are in addition to those contained in ARM 37.85.401, 37.85.402, 37.85.406, 37.85.407, 37.85.410, 37.85.412, 37.85.413, 37.85.414, and 37.85.415.

            (2)  General requirements for mMedicaid coverage of transplantations are as follows:

            (a)  The transplantation must be medically necessary.

            (b)  Prior authorization for referral to an out-of-state facility for an evaluation and organ transplantation must be obtained from the department or its designated review organization.

            (c)  The transplant candidate must meet the patient selection criteria set forth by the department's designated review organization.

            (d)  The medicaid program covers only the following organ transplantation services for persons over the age of 21, subject to the provisions of (2)(e):

            (i)  allogenic and autologous bone marrow;

            (ii)  kidney, inclusive of thoracic duct drainage and dental exam;

            (iii)  cornea;

            (iv)  lymphocyte immune globulin preparation.

            (e)  For purposes of establishing organ transplant requirements and to more specifically defining coverage or non-coverage of various types of organ transplanta­tions, the department hereby adopts and incorporates by reference the following sections of the Medicare Coverage Issues Manual (HCFA-Pub. 6) published by the health care financing administration of the United States department of health and human services.  A copy of the incorporated sections of the Medicare Coverage Issues Manual (HCFA-Pub. 6) may be obtained from the Department of Public Health and Human Services, Health Policy and Services Division, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951. The incorporated sections are as follows:

            (i)  HCFA-Pub. 6, section 35-30, as amended through March 1992, pertaining to allogenic and autologous bone marrow transplantation;

            (ii)  HCFA-Pub. 6, section 35-50, as amended through September 1991, pertaining to non-coverage of the medical procedure cochleostomy with neurovascular transplant for treatment of meniere's disease;

            (iii)  HCFA-Pub 6, section 35-53.1, as amended September 1991, pertaining to pediatric liver transplantation;

            (iv)  HCFA-Pub. 6, section 35-58, as amended through April 1983, pertaining to thoracic duct drainage (TDD) as a covered service when furnished to a kidney transplant recipient or individual approved to receive a transplant;

            (v)  HCFA-Pub. 6, section 35-82, as amended through January 1988, pertaining to non-coverage of pancreas trans­plantation;

            (vi)  HCFA-Pub. 6, section 35-87, as amended through May 1989, pertaining to heart transplants;

            (vii)  HCFA-Pub. 6, section 45-22, as amended through June 1988, pertaining to FDA approval and use of lymphocyte immune globulin preparations;

            (viii)  HCFA-Pub. 6, section 50-23, as amended through July 1990, pertaining to the safe and effective use of histocompatibility testing procedures; and

            (ix)  HCFA-Pub. 6, section 50-26, as amended through May 1989, pertaining to dental exam as part of a comprehensive workup prior to a renal transplant surgery.

            (a)  Medicaid will only cover medically necessary organ or tissue transplants.

            (i)  Services must comply with Medicare coverage guidelines for organ or tissue transplant service.

            (ii)  If Medicare coverage guidelines are not available, the department or the department's designated review organization will review the requested transplant surgery to determine whether the surgery is medically necessary and is not experimental or investigational.

            (b)  All cases presented for organ or tissue transplantation require prior authorization from the department's designated review organization, with the exception of corneal transplantation.

            (c)  Organ transplants must be performed in a Medicare certified center.  If Medicare has not designated a certified center, the transplant must be performed by a program that is located in a hospital or parts of a hospital certified by the Organ Procurement and Transplantation Network (OPTN) for the specific organ being transplanted.

            (3)  The medicaid program covers organ transplantation services for persons 21 years of age or less as determined medically necessary, subject to the provisions of ARM 37.86.4701 and (2)(a) through (2)(e) of this rule.  Services considered experimental and/or investigational are not a benefit of the Montana Medicaid Program.

            (a)  Experimental and/or investigational services include:

            (i)  Procedures and items including prescription drugs, considered experimental and/or investigational by the U.S. Department of Health and Human Services or any other appropriate federal agency.

            (ii)  Procedures and items, including prescribed drugs, provided as part of a control study, approved by the Department of Health and Human Services or any other appropriate federal agency to demonstrate whether the item, prescribed drug, or procedure is safe and effective in caring, preventing, correcting, or alleviating the effects of certain medical conditions.

            (iii)  Procedures and items, including prescribed drugs, which may be subject to question, but are not covered in (3)(a)(i) and (ii), will be evaluated by the department or the department's designated medical review organization to determine whether they are experimental and/or investigational.

 

            AUTH:  53-2-201, 53-6-113, MCA

            IMP:  53-2-201, 53-6-101, 53-6-113, 53-6-131, 53-6-141, MCA

 

            37.86.4706  ORGAN TRANSPLANTATION, REIMBURSEMENT

            (1)  Reimbursement for physician services in organ transplantation is provided in accordance with the methodologies described in ARM 37.85.212 and 37.86.105.

            (2)  All hospital services for organ and tissue transplantation are reimbursed as provided for in ARM 46.12.509 37.85.212, 37.86.2801, 37.86.2806, 37.86.2907, 37.86.2916, 37.87.3005, 37.87.3009, 37.87.3020, 37.87.3025, and 37.87.3037.

 

            AUTH:  53-2-201, 53-6-113, MCA

            IMP:  53-2-201, 53-6-101, 53-6-131, 53-6-141, MCA

 

            4.  The Department of Public Health and Human Services (the department) is proposing the amendment of ARM 37.86.4701, 37.86.4705, and 37.86.4706 pertaining to Medicaid coverage of organ and tissue transplants.  The proposed amendments are necessary to extend coverage of medically necessary organ and tissue transplantations to include all Medicare covered organ and tissue transplants to all Medicaid recipients.  Prior to these proposed amendments, medically necessary transplants were covered services for Medicaid-eligible children through age 20 and were limited to bone marrow, kidney, cornea, and lymphocyte immune globulin for adults.

 

The department is taking this opportunity to update requirements for Medicaid coverage of transplant services and references pertaining to provider reimbursement.

 

The proposed amendments are described in detail below.

 

ARM 37.86.4701

 

The department is proposing amendments to this rule containing definitions of terms applicable to the transplant rules.  The amendments would delete the reference to bone marrow in the definition of "organ transplantation" because it would be included in a new definition, "tissue transplantation".  The department is proposing that "tissue transplantation" including corneal, bone marrow, and peripheral stem cell transplants be added to "tissue transplantation" throughout the subchapter.

 

ARM 37.86.4705

 

The department is proposing amendments that would update this rule containing coverage requirements and would remove all references to the Medicare Coverage Issues Manual (HCFA Pub. 6).  The proposed amendments would make the rule interpretation and procedure coding advice provisions of ARM 37.85.412 and 37.85.413 available to providers of Medicaid transplantation services.  These provisions have been created since this rule was last amended and the department believes they should be added to the references in this rule to avoid confusion about their applicability.

 

The proposed amendments would except corneal transplantation from the requirement that transplantation services be authorized by the department's designated review organization before they can be provided.

 

We are also proposing to specify that the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS), the federal agency responsible for administering the Medicare and Medicaid programs, is the agency that certifies transplant centers.  The department is proposing the addition of a provision to address the possibility that Medicare has not designated a certified center for certain transplants.  In such event, the department proposes that the transplant be performed in a facility certified by the Organ Procurement and Transplantation Network (OPTN) for the specific organ being transplanted.

 

The department is also proposing a methodology for determining whether a transplant procedure or drug is experimental or investigational and, therefore, not covered by Medicaid.  The proposal would follow determinations by the U.S. Department of Health and Human Services or any other appropriate federal agency that a procedure or drug is experimental or investigational.  Any procedure or drug provided as part of a control study, approved by the Department of Health and Human Services or any other appropriate federal agency would also be considered experimental or investigational.  For procedures or drugs subject to question, but not determined experimental or investigational by the Department of Human Services or other federal agency, the department proposes that they be evaluated by the department or the department's designated medical review organization to determine whether they are experimental or investigational.

 

ARM 37.86.4706

 

The department is taking this opportunity to update the reimbursement of transplantation services.  The amendments would remove an obsolete reference to repealed ARM 46.12.509 and substitute references to ARM 37.85.212, 37.86.2801, 37.86.2806, 37.86.2907, 37.86.2916, 37.87.3005, 37.87.3009, 37.87.3020, 37.87.3025, and 37.87.3037, setting forth reimbursement methodologies under the Prospective Payment System (PPS).

 

Options Considered

 

Since the proposed implementation of medically necessary transplantation benefits for persons over the age of 20 are the result of a policy decision, other options were not considered.  The other proposed amendments are necessary to update these rules to reflect current department practices.

 

These proposed amendments are intended to have a positive effect on persons eligible for Montana Medicaid.  They would be able to access transplantation services through the Medicaid program with no age limit restrictions.

 

Estimated Financial and Budget Impacts

 

The total projected budget increase for the transplantation services proposed in these amendments for state fiscal year (SFY) 2010 is $5,369,536.  Of this, the state share would be $1,722,010 and the federal share $3,647,526.  For SFY 2011 the total increase is projected at $5,691,708.  The state share would be $1,837,853 and federal share would be $3,853,855.  The projections are based on the estimation that there will be ten adult transplants each fiscal year.

 

            5.  The department intends to apply these rules retroactively to October 4, 2008.  A retroactive application of the proposed rules would not result in a negative impact to any affected party.

 

            6.  Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing.  Written data, views, or arguments may also be submitted to: Rhonda Lesofski, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., September 10, 2009.

 

7.  The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

8.  The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices.  Notices will be sent by e-mail unless a mailing preference is noted in the request.  Such written request may be mailed or delivered to the contact person in 6 above or may be made by completing a request form at any rules hearing held by the department.

 

9.  An electronic copy of this Proposal Notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the Notice conform to the official version of the Notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the Notice and the electronic version of the Notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

10.  The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

 

 

 

/s/  John Koch                                                /s/  Anna Whiting Sorrell                              

Rule Reviewer                                               Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services

 

Certified to the Secretary of State August 3, 2009.