SUMMARY
This appeal is the result of Respondent BCBSM's refusal to pay approximately twelve thousand dollars ($12,000.00)[1] of medical bills for their insured, Petitioner James Anton, from July 2005, continuing through the present. Petitioner James Anton Petitioner suffers from a rare medical condition, mitochondrial cardiomyopathy, that is almost always fatal within a relatively short period of time. The “traditional treatment” is invariably a heart transplant (if the patient is lucky enough to qualify, which Petitioner did not), which is a very costly treatment, that has a severe negative impact on the quality of the relatively short life expectancy of those that suffer from mitochondrial cardiomyopathy[2].
Respondent BCBSM, under lawsuit from the Department of Justice, has refused to pay for the prudent, life saving, and quality of life extending medical treatment of Petitioner. This despite the fact that Petitioner has survived for fifteen years, with relatively reasonable quality of life, due to the medical care and treatment provided by Edward Lichten MD.
Said treatments were paid when Dr. Lichten was a “participating physician”[3], and were paid to another participating physician, but not to Dr. Lichten after Dr. Lichten was no longer a participating physician.
Dr. Lichten's medical care is appropriate, i.e. “medically necessary” under the criteria Respondent BCBSM was Ordered to apply to its existing contracts, in accordance with a 2008 consent Judgment and Order in the Love, et al. v. Blue Cross Blue Shield Ass’n, et al., (formerly Thomas, et al. v. Blue Cross Blue Shield Ass’n, et al.), Case No. 03-21296-CIV-MORENO/SIMONTON (See Exhibit 1).
However, Respondent OFIR, improperly dismissed Petitioner's request that the legally correct definition of “medical necessity” be applied[4], and instead applied an illegal definition of “medical necessity”, one that was legally superseded by the definition Ordered and consented to by Respondent BCBSM, in accordance with the Love Order, and therefore the decision of OFIR, denying payment for Dr. Lichten's services, must be reversed, and Petitioner must be compensated for such medical care.
BACKGROUND FACTS AND PROCEDURAL HISTORY
Petitioner James Anton is a 55 year old male that is currently being treated for a number of medical conditions, including but not limited to, mitochondrial cardiomyopathy, due to a genetic mitochondrial defect causing congestive heart failure. He also suffers from progressive kidney disease, prior kidney stones, liver abnormality, chronic back pain, hyperlipidemia and polycythemia, among other medical conditions. Mitochondrial cardiomyopathy is an extremely rare medical condition “an orphan disease” that is substantially different from other forms of cardiomyopathy including the prognosis, etiology and treatment (See Administrative Record, pg 4, “rare disease”, and Administrative Record, pg 146-149).
The diagnosis of mitochondrial cardiomyopathy was made in 1995, at the University of Michigan Hospital, and at the time according to Petitioner, Petitioner was told by the treating cardiologist, that the Petitioner had ten months to live with virtually no chance of survival beyond that time (See Administrative Record pg. 7, letter from Petitioner footnotes).
Petitioner began treatment with Dr. Edward Lichten in 1996, and his health improved significantly. During the course of Petitioner's treatment with Dr. Lichten, his heart function improved greatly, with the left ventricular ejection fraction improving from 15% to 40%, an improvement of over 250% (See Administrative Record pg. 15, letter from Dr. Lichten to Valerie Glosson).
These treatments of Petitioner by Dr. Edward Lichten were part of a prudent, comprehensive and individualized course of therapy that required constant monitoring and fine-tuning in addition to routine medical care. The medications and procedures within the individualized course of therapy for Petitioner included growth hormone, testosterone, nandrolone, stanazolol, oxandrin, human chorionic gonadotropin, carnitor liquid, armour thyroid, chromagen, coenzyme q10, and intravenous infusions and phlebotomy. The above medical care by Dr. Lichten is the only explanation for the remarkable improvement in the Petitioner’s health: From being bedridden and totally disabled and literally dying to living a more normalized independent life with an extended life-expectancy.
BCBSM had paid for the above treatment by Dr. Lichten directly to Dr. Lichten as a participating physician from 1996, until December 2003. BCBSM placed Dr. Lichten in Pre-Payment Utilization Review (PPUR) in January 2004 and virtually stopped all reimbursements to Lichten’s patients thereafter. BCBSM continued to reimburse Petitioner for some services in 2004.
When Petitioner went to a new participating physician Mark Hertzberg MD, shortly thereafter, BCBSM paid for HGH, testosterone, and nadorlone, the same treatments BCBSM refused to pay Dr. Lichten for.
Petitioner then resumed treatment with Dr. Lichten. At issue are treatments provided by Dr. Lichten from July 6, 2005 until the present date. BCBSM denied hand-delivered multiple submissions of Petitioner’s claims with accompanying medical records for reimbursement of medical services and medications dispensed, administered or prescribed by Dr. Lichten (See Administrative Record pg. 5, letter from petitioner stating entire records were submitted “six times”).
During the relevant time period and continuing to present, Dr. Lichten submitted: 1) paper claims with medical documentation; 2) copies of all paper claims on CD-ROM to the BCBSM attorney, Mr. Leo Nouhan; and 3) attempts at electronic transmission through a third party, Capario.
The electronic transmissions were blocked by a BCBSM employee, Stacey Sartin, who stated to Dr. Lichten that the EDI key was removed on order of BCBSM PPUR.
All of these flagrant, willful and illegal actions by BCBSM resulted in no payments being made to Petitioner to the detriment of his physical and mental health despite the clear legal obligation of BCBSM to the make such payments in a timely fashion as argued below.
It cannot be overstressed, and it is Petitioner's position, that these actions were in no small part due to BCBSM unwarranted and illegal animus toward Dr. Lichten for reasons including but not limited to his vigorous advocacy for his patients’ necessary, cost-effective and life-saving treatments. The treatments at issue are listed in the Administrative Record, pg. 95-98[5].
Petitioner filed a request for external review on November 23, 2009 in accordance with the Patient's Right to Independent Review Act (PRIRA), MCL 550.1901 et seq., According to OFIR, the request for external review was not accepted because Petitioner had not completed BCBSM's internal grievance process. However, the record clearly shows, and as stated above, that the Petitioner requested internal review by BCBSM on numerous occasions. It was only after OFIR became involved and Petitioner resubmitted all medical records and claims for the seventh time that BCBSM initiated the internal review process (See Administrative Record, pg. 26, request for OFIR review). On February 22, 2010, BCBSM agreed to respond to the internal grievance review process.
Petitioner argued that the services provided by Dr. Lichten were medically necessary, and they saved James Anton's life, and that the services were being denied for other, illegal reasons, directed by BCBSM against Dr. Lichten. Petitioner also argued that the Commissioner was bound to analyze the issue of medical necessity in accordance with Love,et al. v. Blue Cross Blue Shield Ass’n, et al., (formerly Thomas, et al. v. Blue Cross Blue Shield Ass’n, et al.), Case No. 03-21296-CIV-MORENO/SIMONTON (See Administrative Record, pg. 160-162, OFIR's ORDER).
After receiving Petitioner’s request for review, BCBSM responded on March 18, 2009, after a new request for external review by OFIR was filed and accepted in March 2010. The Commissioner assigned the case to an Independent Review Organization, MAXIMUS, in accordance with PRIRA, since medical issues were involved.
MAXIMUS provided its recommendations and analysis to the Commissioner on March 24, 2010. MAXIMUS approved some of the services and treatment, provided by Dr. Lichten, that were rejected by BCBSM, but denied others as not “Medically Necessary” (See Administrative Record, pg. 163-165, OFIR's ORDER):
[Petitioner] has cardiomyopathy that is not being treated with standard proven medications due to intolerance and/or his refusal. The… medications with which the [Petitioner][ is being treated have not been shown in rigorous scientific studies to improve outcomes in patients with cardiomyopathy and are not part of the standard accepted treatment of cardiomyopathy in the medical community…[N]one of these medications are recommended for the treatment of chronic heart failure according to expert guidelines endorsed by several national organizations. [Citation omitted]
[T]he reference regarding growth hormone treatment in the New England Journal of Medicine which was referred to by the [Petitioner’s] treating physician did not assess outcomes and was not controlled
[M]ore recent data evaluating testosterone treatment for patients with chronic heart failure demonstrate little or no effect on cardiac function with no outcomes data and no data on the safety of chronic use in this population. [Citation omitted]
The use of a diuretic, such as Demadex, to relieve congestive systems and a Beta blocker, such as Inderal, are standard accepted treatments for cardiomyopathy…If glucose intolerance is present, treatment with agents such as Metformin is indicated and of proven value…If a fungal infection is present, then treatment with Diflucan would also be appropriate…The variable course that patients with cardiomyopathy often display can result in the need for period[ical] clinic visits and frequent monitoring of fluid, electrolytes as intravascular volume and renal function fluctuate …Periodic follow-up visits and blood draws are appropriate.
The Commissioner, in its Order, also stated that the Love, supra, Settlement Agreement and Order, was not applicable (See Administrative Record, pg. 162, OFIR ORDER) . The Commissioner adopted the recommendation of MAXIMUS and issued its ORDER on April 19, 2010. Petitioner then appealed from the ORDER on June 3, 2010, which is the basis for the appeal before this honorable Court.
ARGUMENT
I. THE DECISION OF THE COMMISSIONER OF OFIR IS NOT AUTHORIZED BY LAW BECAUSE THE COMMISSIONER BASED HIS DECISION ON AN INAPPLICABLE, INOPERATIVE AND ILLEGAL DEFINITION OF “MEDICAL NECESSITY” IN VIOLATION OF LOVE VS BCBS Ass’n..
The standard of review for decisions of an administrative agency or officer, in cases in which no hearing is required, is a review to determine whether the decisions are authorized by law. Const. 1963, art. 6, §28.
In Ross v Blue Care Network of Michigan, 271 Mich App 358 (2006), the Court of Appeals stated:
An administrative decision is unauthorized by law if it is: (1) in violation of a statute or the Constitution, (2) in excess of the statutory authority or jurisdiction of the agency, (3) made upon unlawful procedures resulting in material prejudice, or (4) arbitrary and capricious.
Id. at 379.
In addition, statutory interpretation is an issue of law, which is reviewed de novo. Lapeer Co. Clerk v. Lapeer Circuit Judges, 465 Mich. 559, 566, 640 N.W.2d 567 (2002). Contract interpretation is also a question of law, and is reviewed de novo, by an appellate court. Holmes v Holmes, 281 Mich.App. 575, 587; 760 N.W.2d 300 (2008).
There have only been two appellate cases in Michigan that have involved PRIRA: Ross v. Blue Care Network of Michigan, 480 Mich. 153, 747 N.W.2d 828 (Mich. 2008), and English v. Blue Cross Blue Shield of Michigan, 263 Mich.App. 449, 688 N.W.2d 523 (Mich.App. 2004).
The Ross case held that the Commisioner of OFIR is not bound by the recommendation of the Independent Review Organization (IRO). The English case held that PRIRA was constitutional, and that the Circuit Court should have affirmed the Commissioner’s Order that BCBSM pay for the blood tests.
A. O.F.I.R. applied the wrong definition of “medical necessity”, and thus its decision was “unauthorized by law”, because such a review would have been an “unlawful procedure”, “arbitrary and capricious”, and an incorrect application of the law.
The definition of “medical necessity”, applicable to this case, was the result of a stipulated Court Order that was part of a settlement agreement in Love, supra (See Exhibit 1, pg. 47, § 7.16 (a)).
This stipulated Order, was the result of serious allegations of misconduct against BCBSM. Although conduct alleged in other court cases, general allegations, judgments, and other conduct by BCBSM is not necessarily legally relevant to this case, it should be noted that the Love Court Order resulted from Racketeering Influenced and Corrupt Organization (“RICO”) allegations against Respondent BCBSM. In fact, BCBSM is presently being sued by the Justice Department. Although the Government's allegations in that case are extensive, they can be summarized as follows: Blue Cross acted against its insured members, by engaging in illegal conduct that gave certain contractors “most favored nation” status . These alleged illegal acts were systematic and pervasive (See Exhibit 2).
In 1995, Blue Cross/Blue Shield of Michigan paid a total of $51.6 million to settle charges that it falsified audit reports and used Medicare money to pay claims that were the responsibility of other insurers (See
The Love, supra, action, filed in 1999, involved 900,000 physicians in a RICO class action litigation filed in federal court. The complaint and request for relief asked the Court to Order Blue Plans throughout the Country, including BCBSM, to cease and desist alleged unlawful policies and procedures that undermined the medical care that Blue members received. The lawsuit resulted in the Love Consent Judgment and Court Order. (Exhibit 1). This included a revised definition of “medical necessity” and new mandates for processing all Blue Cross and Blue Shield claims in a timely manner, both applicable to the Petitioner, and the instant case before the court.
1. The Love stipulated Order applies to the instant case.
Respondent BCBSM was a Defendant in the LOVE case. According to the terms of the LOVE Court Order, BCBSM agreed to the jurisdiction of the Court, and not to challenge that Jurisdiction (See Exhibit 1, §20.1 Continuing Jurisdiction, and §20.2 Parties Shall Not Contest Jurisdiction).
Respondent BCBSM also agreed that with respect to any internal or external review, involving “medical necessity”, the Love definition, § 7.16 (a),would apply, and this definition that BCBSM agreed to, was not dependent on whether or not the Love Plaintiffs were parties to the agreement, or whether or not participating physicians were involved. Therefore, the Love Court Order applies to Petitioner James Anton (See Exhibit 1, pg 36 et seq).
Section 7.11 (b)(3)(iii) of the LOVE court order applies,
except where any applicable law or regulation requires a
different definition, each Blue Plan shall use the definition
of Medical Necessity set forth in § 7.16 (a) of this
Agreement in the internal appeal and external review
processes set forth in this § 7.11; provided, however, that
nothing in this Agreement shall: (a) limit or prevent the
Blue Plan from denying coverage on the grounds that
services are experimental or investigational; or (b) alter or
restrict the Blue Plan’s rights under its contracts with
Participating Physicians to restrict or prohibit them from
billing the Blue Plan’s Plan Member for services
determined to be not Medically Necessary or experimental
or investigational. Each Blue Plan agrees that Physicians
may bill its Plan Members for services determined to be not
Medically Necessary or experimental or investigational
when the Physician provides the Blue Plan’s Plan Member
with advance written notice that (a) identifies the proposed
services, (b) informs that Plan Member that such services
may be deemed by the Blue Plan to be not Medically
Necessary or experimental or investigational, and (c)
provides an estimate of the cost to that Plan Member for
such services and that Plan Member agrees in writing in
advance of receiving such services to assume financial
responsibility for such services.
§7.16(a) provides:
§7.16 Application of Clinical Judgment to Patient-Specific and Policy Issues
(a) Patient-specific Issues Involving Clinical Judgment
Medical Necessity Definition
Except where any applicable law or regulation requires a different
definition, each Blue Plan shall apply as to its current agreements
and include in its future agreements with Participating Physicians
the following definition of “Medically Necessary” or comparable
term in each such agreement: “Medically Necessary” or
“Medical Necessity” shall mean health care services that a
Physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury or disease; and (c) not primarily for the convenience of the patient, physician, or other health care provider, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease. For these purposes, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, Physician Specialty Society recommendations and the views of Physicians practicing in relevant clinical areas and any other relevant factors.
First, it should be noted that the LOVE Court Order definition of “medical necessity” differs substantially and materially from the previous definition of “medical necessity” which OFIR unlawfully used. Had OFIR applied the correct definition of medical necessity, the only lawful definition, which is the Love definition, then a different result would have ensued (i.e. medical necessity would have been approved and all payments for services ordered for all services previously denied as not being medically necessary). This is because the Love agreement does not require the consensus of the medical community, or require the “standard accepted treatment of cardiomyopathy in the medical community[6]”, nor does the Love Order require “ rigorous scientific studies[7]”, but rather allows the patient's own treating physician to decide on the treatment, provided said treatment is prudent, and backed by credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, which was met in this case as argued more fully herein.