Issued and entered June 12, 2003 by Linda A. Watters, Commissioner

ORDER

I
PROCEDURAL BACKGROUND

On March 28, 2002, XXXXXXXXXXXXXX, on behalf of his son XXXXXXXXXXXXXXXX (Petitioner), filed a request for external review with the Commissioner of the Office of Financial and Insurance Services (Commissioner) under the Patient’s Right to Independent Review Act (PRIRA), MCL 550.1901 et seq. After an assessment of the material submitted, the Commissioner accepted the request on April 4, 2002.

Petitioner’s case required a determination on medical issues; however, the documents he submitted to the Office of Financial and Insurance Services (OFIS) did not contain sufficient medical information for an independent review organization (IRO) to make all of the necessary medical determinations. The Commissioner issued an Interim Order on June 7, 2002, which held this case in abeyance for up to 90 days to give the Petitioner an opportunity to submit additional medical records.

Petitioner submitted medical records to OFIS on July 11, 2002. The Commissioner assigned the case to the Maximus Center for Health Dispute Resolution (CHDR), an IRO. The Commissioner directed CHDR to provide the opinion and recommendation of a medical expert. The IRO completed its review on July 23, 2002, and sent its report to OFIS.

II
FACTUAL BACKGROUND

Petitioner is a Blue Cross Blue Shield of Michigan (BCBSM) member. He suffers from Duchenne Muscular Dystrophy. Petitioner went to the XXXXXXXXXXXXXXXXXXXXXXXXXX, in the XXXXXXX, to undergo embryonic stem cell transplants. Petitioner did not receive prior approval from BCBSM these procedures. He had 24 (or more) stem cell transplants between XXXXXXXXXXXXX and XXXXXXXXXXXXX.

The cost of the stem cell transplants was $47,670. BCBSM denied coverage for the services. The Petitioner appealed the denial through BCBSM’s internal grievance procedures, and BCBSM issued a final adverse determination in his case on March 1, 2002.

III
ISSUE

Did BCBSM properly deny Petitioner coverage for embryonic stem cell transplants, received without pre-authorization, from XXXXXXXXXXXXX – XXXXXXXXXXXXX?

IV
ANALYSIS

PETITIONER’S ARGUMENT

Petitioner is eleven years old. He was diagnosed with Duchenne Muscular Dystrophy at the age of two. Petitioner argues BCBSM should cover the stem cell transplants. The transplants were medically necessary for the treatment of Duchenne Muscular Dystrophy. BCBSM should not deny coverage based on lack of pre-authorization. He tried to get authorization for the treatment, but was told BCBSM did not have the means to preauthorize the transplants. Petitioner also contends BCBSM coverage was improperly denied. The denial was made without reviewing the cell transplant medical records. The Commissioner should reverse BCBSM’s final adverse determination in this case.

BCBSM’S ARGUMENT

Petitioner has health coverage under BCBSM’s Professional Services Group Benefits Certificate (Certificate). BCBSM denied coverage for the stem cell transplants for two reasons. First, the Petitioner did not have pre-authorization for the service. Second, this service is not covered because it is experimental or investigational.

Prior to the Commissioner’s June 7, 2002 Interim Order, BCBSM on April 15, 2002, disallowed coverage for the services based on the provisions in Rider Experimental Bone Marrow Transplant Coverage (EBMT). After the Interim Order, BCBSM filed an addendum to the April 15,2002, position paper. BCBSM determined embryonic stem cell transplants were covered under Rider General Limitations and Exclusions (GLE-1) not Rider EBMT. Section 2 of Rider GLE-1 states:

SECTION 2: SERVICES WHICH ARE NOT PAYABLE
We do not pay for services which are experimental or investigational. Facility services and physician services, including diagnostic tests, which are related to experimental or investigational procedures, are also not payable.

To determine whether stem cell transplants for the treatment of Duchenne Muscular Dystrophy is experimental, a three-panel review by the Medical Care Ombudsman Program (MCOP) was requested. The reviewers concluded the treatment rendered for the stated diagnosis was experimental and not standard of care. BCBSM argues the Commissioner should therefore uphold its final adverse determination in this matter.

IRO’S RECOMMENDATION

The medical expert who reviewed this case is a practicing physician who has board certifications in neurology and in pediatrics. The IRO physician recommended the Commissioner uphold BCBSM’s final adverse determination in Petitioner’s case. The medical expert based that recommendation on the following findings:

• Petitioner’s medical records do not include evidence of treatment and documentation protocols that should be present in a medical investigation or study.
• Petitioner underwent cell therapy in a country where treatment of some medical conditions with fetal cells of non-human origin has been common for many years. The first treatment does not specify whether the embryonic stem cells were human or animal.
• Embryonic stem cell transplantation is considered investigational.
• There is no credible scientific evidence that embryonic stem cell transplantation is of any value in humans with Duchenne Muscular Dystrophy.
• Recent evidence suggests that embryonic stem cell transplantation can induce an immune response, which raises concerns about its safety.

COMMISSIONER’S REVIEW

The Commissioner carefully reviewed the arguments and documents the parties submitted, as well as the findings of the IRO medical expert. The focus of this analysis is whether BCBSM properly denied Petitioner coverage for embryonic stem cell transplants he received from XXXXXXXXXXXXX, to XXXXXXXXXXXXX. The Professional Services Group Benefit Certificate governs Petitioner’s coverage and, in pertinent part, states:

SECTION 4: GENERAL CONDITION OF YOUR CONTRACT

Certain general conditions apply to your Contract. These conditions may make a difference in how, where and when benefits are available to you. This section lists and explains these conditions.

Experimental Services

Services which we determine to be experimental or investigational are not covered by this Certificate. …

“The Language of Health Care” section of the Certificate clarifies this condition of coverage with the following definition:

Experimental or Investigational

A service, procedure, treatment, devise or supply which has not been scientifically demonstrated to be safe and effective for treatment of the patient’s condition.

These provisions clearly and unambiguously establish that experimental medical services are not covered under the Professional Services Group Benefit Certificate. The parties do not argue that the cell therapy Petitioner received was not experimental. Furthermore, the Commissioner accepts the finding of the IRO medical expert, that embryonic stem cell transplantation is experimental. The services at issue in this case are excluded from coverage.

Accordingly, the Commissioner finds that Petitioner’s cell therapy is not a covered benefit under the Professional Services Group Benefit Certificate. Embryonic stem cell transplantation is experimental treatment. In addition BCBSM correctly denied coverage for the services because the Petitioner failed to get pre-authorization before the services were obtained. Therefore, the Commissioner finds that BCBSM’s final adverse determination in the Petitioner’s case is valid.

V
ORDER

The Commissioner upholds BCBSM’s March 1, 2002, final adverse determination in Petitioner’s case. BCBSM properly denied Petitioner coverage for the embryonic stem cell transplants he received from XXXXXXXXXXXXX, to XXXXXXXXXXXXX.

This is a final decision of an administrative agency. Under MCL 550.1915, any person aggrieved by this Order may seek judicial review no later than sixty days from the date of this Order in the Circuit Court for the county where the covered person resides or in the Circuit Court of Ingham County. A copy of the petition for judicial review should be sent to the Commissioner of the Office of Financial and Insurance Services, Health Plans Division, Post Office Box 30220, Lansing, MI 48909-7720.