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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 cardiomyopathy2.
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-CIVMORENO/SIMONTON (See Exhibit 1).
1 Petitioner claims it is $75,000.00 owed. The $12,000 is listed in the Administrative record, pg. 95.
2 Petitioner was told in 1995, by his cardiac specialist that he had approximately ten months to live.
3 A participating physician has a contract with BCBSM.
1
However, Respondent OFIR, improperly dismissed Petitioner's request that the
legally correct definition of “medical necessity” be applied4, 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illegal definition of “medical necessity”, one that was legally superseded by the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).
4 See OFIR'S ORDER, Administrative Record, pg 162, dismissing Dr. Lichten's correct request of OFIR to apply the
Love definition of “medical necessity”.
2
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 PrePayment 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
3
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. 95-985.
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
5 Petitioner claims the amount is $75,000.00.
4
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
5
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
6
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,
7
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 http://www.allbusiness.com/human-resources/benefitsinsurance-health-types/706551-1.html).
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.
8
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:
9
§7.16 Application of Clinical Judgment to Patient-Specific and
Issues
(a) Patient-specific Issues Involving Clinical Judgment
Medical Necessity Definition
Policy
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
10
medical community6”, nor does the Love Order require “ rigorous scientific studies7”, 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 peerreviewed medical literature generally recognized by the relevant medical community,
which was met in this case as argued more fully herein.
The important distinction and difference between pre Love and post Love
definitions of “medical necessity” is that post Love, the physician's clinical
judgment is given much more weight, deference, and leeway. Prior to Love, the
Physician had to follow the “majority rule” to satisfy “medical necessity”.
Here, Dr. Lichten satisfied that test because “as the physician, exercising prudent
clinical judgment, he did provide to a patient for the purpose of preventing, evaluating,
diagnosing or treating an illness, injury, disease or its symptoms and that the treatments
and medications 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 like to produce
equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the
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 peerreviewed medical literature generally recognized by the relevant medical
community, Physician Specialty Society recommendations and the view of
Physicians practicing in relevant clinical areas and any other relevant factors. (
6 See Administrative Record pg 163 erroneously requiring “standard accepted treatment”.
7 See Administrative Record pg 163 erroneously requiring “rigorous scientific studies”.
11
See Exhibit 1, pg. 47, Love Consent Judgment and Order §7.16(a)).
Petitioner's treatment, provided by Dr. Lichten, meets the Love definition of “generally
accepted standards of medical practice” because:“Treatment is based on credible
scientific evidence published in peer-reviewed medical literature generally recognized by
the relevant medical community.” OFIR did not apply this definition, although required to
do so.
B. Treatment with human growth hormone was medically necessary.
Petitioner's treatment with human growth hormone was based on the credible
scientific evidence in support of such use in patients with idiopathic cardiomyopathy, first
reported by Fazio in the New England Journal of Medicine in 1996. “Growth hormone also
improved clinical symptoms, exercise capacity, and the patients' quality of life. The
changes in cardiac size and shape, systolic function, and exercise tolerance were
partially reversed three months after growth hormone was discontinued”. Fazio S,
Sabatini D, et al, A preliminary study of growth hormone in the treatment of dilated
cardiomyopathy, New England Journal of Medicine, 1996 Mar 28; 334(13):809-14.
PMID: 8596546. The abstract provided as follows:
Comment in:
N Engl J Med. 1996 Mar 28;334(13):856-7.
N Engl J Med. 1996 Aug 29;335(9):672-3; author reply 673-4.
N Engl J Med. 1996 Aug 29;335(9):672; author reply 673-4.
BACKGROUND: Cardiac hypertrophy is a physiologic response that allows the
heart to adapt to an excess hemodynamic load. We hypothesized that inducing
cardiac hypertrophy with recombinant human growth hormone might be an
effective approach to the treatment of idiopathic dilated cardiomyopathy, a
condition in which compensatory cardiac hypertrophy is believed to be deficient.
METHODS: Seven patients with idiopathic dilated cardiomyopathy and
moderate-to-severe heart failure were studied at base line, after three months of
12
therapy with human growth hormone, and three months after the discontinuation
of growth hormone. Standard therapy for heart failure was continued throughout
the study. Cardiac function was evaluated with Doppler echocardiography, rightheart catheterization, and exercise testing.
RESULTS: When administered at a dose of 14 IU per week, growth hormone
doubled the serum concentrations of insulin-like growth factor I. Growth hormone
increased left-ventricular-wall thickness and reduced chamber size significantly.
Consequently, end-systolic wall stress (a function of both wall thickness and
chamber size) fell markedly (from a mean [+/-SE] of 144+/-11 to 85+/-8 dyn per
square centimeter, P<0.001). Growth hormone improved cardiac output,
particularly during exercise (from 7.4+/-0.7 to 9.7+/-0.9 liters per minute,
P=0.003), and enhanced ventricular work, despite reductions in myocardial
oxygen consumption (from 56+/-6 to 39+/-5 ml per minute, P=0.005) and energy
production (from 1014+/-100 to 701+/-80 J per minute, P=0.002). Thus,
ventricular mechanical efficiency rose from 9+/-2 to 21+/-5 percent (P=0.006).
Growth hormone also improved clinical symptoms, exercise capacity, and the
patients' quality of life. The changes in cardiac size and shape, systolic function,
and exercise tolerance were partially reversed three months after growth
hormone was discontinued.
CONCLUSIONS: Recombinant human growth hormone administered for three
months to patients with idiopathic dilated cardiomyopathy increased myocardial
mass and reduced the size of the left ventricular chamber, resulting in
improvement in hemodynamics, myocardial energy metabolism, and clinical
status.
PMID: 8596546 [PubMed - indexed for MEDLINE
Here, Petitioner when treated with Human Growth Hormone and showed improved
clinical symptoms, exercise capacity (able to run on a treadmill for miles), and improved
quality of life, during the course of such treatment by Dr. Lichten. There is no other
explanation for Petitioner's remarkable improvement under the care of Dr. Lichten, other than
the treatment provided.
To further support the “cause and effect” of the treatment provided by Dr.
Lichten, when the treatment of growth hormone was significantly decreased recently
due to inability of Petitioner to pay for this medication, the beneficial changes in
cardiac size and shape, systolic function (ejection fraction) and exercise tolerance
were partially reversed, resulting in two hospital admissions to the ICU in the last six
months. This unfortunate and shameful result was because of the illegal refusal by
13
Respondent BCBSM to pay for Petitioner's treatment, despite Petitioner's payment of
his premiums8.
In further support of the prudent treatment Petitioner received by Dr. Lichten,
subsequent medical articles in peer-reviewed medical literature also support the
therapeutic trial of human growth hormone in individuals with cardiomyopathy. Therefore,
this treatment is “considered effective for the patient’s illness”, see LOVE Consent
Judgment and Order §7.16(a)(a). See also Capaldo B & Fazio S et al. Sympathetic
deactivation by growth hormone treatment inpatients with dilated cardiomyopathy,
European Heart Journal. 1998 Apr; 19(4): 623-7. The abstract provided:
Comment in:
Eur Heart J. 1999 Feb;20(3):242-3.
Eur Heart J. 1999 Feb;20(3):243-4.
AIMS: We examined the effects of growth hormone administration on the
sympathetic nervous system in patients with idiopathic dilated cardiomyopathy.
BACKGROUND: Growth factor therapy is emerging as a new potential option in
the treatment of heart failure. Although growth hormone provides functional
benefit in the short term, it is unknown whether it affects the sympathetic
nervous system, which plays a role in the progression of heart failure.
METHODS: Seven patients with idiopathic cardiomyopathy received 3 months
treatment with recombinant human growth hormone (0.15-0.20 IU.kg-1.week-1).
Standard medical therapy was unchanged. Myocardial norepinephrine release,
both at rest and during submaximal physical exercise, plasma aldosterone, and
plasma volume were measured before and after growth hormone treatment.
Myocardial norepinephrine release was assessed from arterial and coronary
venous plasma concentrations of unlabelled and tritiated norepinephrine and
coronary plasma flow (thermodilution).
RESULTS: Growth hormone induced a significant fall in myocardial
norepinephrine release in response to physical exercise (from 180 +/- 64 to 99
+/- 34 ng.min-1; P < 0.05). Basally, plasma aldosterone was 189 +/- 28 and 311
+/- 48 pg.ml-1 in the supine and upright position, respectively, and fell to 106 +/16 (P < 0.01) and 182 +/- 29 pg.ml-1 (P < 0.05) after growth hormone therapy.
Growth hormone increased plasma volume from 3115 +/- 493 ml to 3876 +/- 336
ml (P < 0.05), whereas serum sodium and potassium concentrations were
8 Respondent BCBSM has these latest medical records.
14
unaffected.
CONCLUSIONS: The data demonstrate that growth hormone administration to
patients with idiopathic cardiomyopathy reduces myocardial sympathetic drive
and circulating aldosterone levels. This neurohormonal deactivation may be
relevant to the potential, long-term use of growth hormone in the treatment of
patients with heart failure.
PMID: 9597412 [PubMed - indexed for MEDLINE
Fazio, S et al. Effects of growth hormone on exercise capacity and cardiopulmonary
performance in patients with chronic heart failure. [22 patients] Journal of Clinical
Endocrinology and Metabolism 2007 Nov; 92(11): 4218-23. The abstract provided:
BACKGROUND: Because GH exerted beneficial effects in various experimental
models of heart failure, we investigated the effects of GH on physical exercise
capacity and cardiopulmonary performance in patients with dilated
cardiomyopathy and chronic heart failure (CHF).
METHODS: Twenty-two patients with CHF (New York Heart Association
functional class II-III) underwent spirometry and a symptom-limited,
cardiopulmonary exercise testing before and after 3 months of GH (n = 11;
seven males; seven idiopathic; 57 +/- 11 yr; 4 IU sc every other day) or placebo
(n = 11; eight males; six idiopathic; 54 +/- 10 yr) administration, in a randomized,
double-blind trial. Background CHF therapy remained unchanged.
RESULTS: GH, but not placebo, increased IGF-I serum concentration (from 144
+/- 35 to 293 +/- 58 ng/ml; P < 0.005) and improved New York Heart Association
functional class (from 2.4 +/- 0.5 to 1.8 +/- 0.4; P < 0.005), exercise duration
(from 831 +/- 273 to 925 +/- 266 sec; P < 0.005), peak power output (from 245
+/- 127 to 280 +/- 132 W; P < 0.05), peak minute ventilation (from 52.5 +/- 16.1
to 61.3 +/- 17.3 liters/min; P < 0.05), peak oxygen consumption (from 19.8 +/5.6 to 25.1 +/- 5.6 ml/kg.min; P < 0.005), and anaerobic threshold (from 14.9 +/4.8 to 20.0 +/- 4.5 ml/kg.min; P < 0.005) without affecting lung function
parameters. Furthermore, the slope of the relationship between minute
ventilation and pulmonary carbon dioxide production (ventilatory efficiency)
decreased from 34.7 +/- 5.1 to 31.7 +/- 5.3 (P < 0.005), whereas the slope of the
relation between percent predicted heart rate reserve used and percent
observed metabolic reserve used (chronotropic index) rose from 0.57 +/- 0.20 to
0.69 +/- 0.18 (P < 0.005).
CONCLUSION: Given the predictive value of physical exercise capacity and
cardiopulmonary performance in CHF progression, these data provide additional
insights into the mechanisms by which GH may potentially benefit CHF patients.
PMID: 17698902 [PubMed - indexed for MEDLINE
15
Castellano G, Fazio S et al. The GH/IGF-1 Axis and Heart Failure, Current Cardiology
Review 2009 Aug; 5(3): 203-15. The abstract provided:
The growth hormone (GH)/insulin-like growth factor 1 (IGF-1) axis regulates
cardiac growth, stimulates myocardial contractility and influences the vascular
system. The GH/IGF-1 axis controls intrinsic cardiac contractility by enhancing
the intracellular calcium availability and regulating expression of contractile
proteins; stimulates cardiac growth, by increasing protein synthesis; modifies
systemic vascular resistance, by activating the nitric oxide system and
regulating non-endothelial-dependent actions. The relationship between the
GH/IGF-1 axis and the cardiovascular system has been extensively
demonstrated in numerous experimental studies and confirmed by the cardiac
derangements secondary to both GH excess and deficiency. Several years ago,
a clinical non-blinded study showed, in seven patients with idiopathic dilated
cardiomyopathy and chronic heart failure (CHF), a significant improvement in
cardiac function and structure after three months of treatment with recombinant
GH plus standard therapy for heart failure. More recent studies, including a
small double-blind placebo-controlled study on GH effects on exercise tolerance
and cardiopulmonary performance, have shown that GH benefits patients with
CHF secondary to both ischemic and idiopathic dilated cardiomyopathy.
However, conflicting results emerge from other placebo-controlled trials. These
discordant findings may be explained by the degree of CHF-associated GH
resistance. In conclusion, we believe that more clinical and experimental studies
are necessary to exactly understand the mechanisms that determine the
variable sensitivity to GH and its positive effects in the failing heart.
PMID: 20676279
Although Fazio reported only seven (7) cases in his 1996 publication, above, due to the
rarity of this condition, Dr. Lichten has treated three (3) cases since 1996 all with
comparable excellent results.
In fact, credible scientific evidence supports the fact that long term growth hormone
deficiency is a cause of cardiomyopathy: Fazio S, et al, Long-term growth hormone deficiency
as a cause of cardiomyopathy and its reversibility, Journal of Clinical Endocrinology
Metabolism 1996; 81: 887-890 .
Although not all published peer review journal are overtly supportive of human growth
hormone in the treatment of the general classification of patients with cardiomyopathy, that
16
fact does not preclude trying the therapy for a specific period of time to determine if the
results warrant continuation. This is a prudent course of clinical action given the fact that the
only alternative available was, and is heart transplant. According to the lower record, the
University of Michigan indicated that a one-million dollar heart transplant procedure was not
indicated for Petitioner, nor the $50,000 per year medical expense of containing host
rejection.
The use of human growth hormone and the other medications prescribed by Dr.
Lichten, has proven to be both cost effective as well as prudent and an acceptable treatment
that warrants initial treatment while observing measurable outcome. See Isqaard J, Bergh
CH, Clinical potential of growth hormone in the treatment of congestive heart failure BioDrugs
1999 Oct; 12(4): 245-50. Young R, Worthley LI. Critical Care Resuscitation 2004 Mar; 6(1):
31-53. The abstract provided:
Substantial evidence supports a role for the growth hormone (GH)/insulin-like
growth factor 1 (IGF-1) axis in regulation of normal cardiac growth, structure and
function. Moreover, experimental data suggest beneficial effects of GH and IGF1 on contractility and peripheral resistance in rats with impaired cardiac function.
An increased Ca(++) responsiveness is one possible underlying cause for the
improvement in contractility, although effects of GH and IGF-1 on apoptosis may
also play a more long term role for cardiomyocyte survival. Until recently, studies
regarding GH treatment in heart failure were limited to case reports where
administration dramatically improved cardiac function. In a small non-blind study
of 7 patients with idiopathic dilated cardiomyopathy and congestive heart failure
(CHF) without GH deficiency who received treatment with recombinant GH
(somatropin) for 3 months, considerable improvement of cardiac function was
reported. More recent studies have demonstrated beneficial effects in patients
with CHF due to both ischaemic and idiopathic dilated cardiomyopathy, with
improvements in haemodynamics when somatropin was added both as a
maintenance therapy and as a short term infusion. So far, 2 placebo-controlled
studies with somatropin as adjunctive therapy in patients with CHF have been
reported, although neither study could confirm previously reported improvement
in systolic function and lowering of wall stress. In summary, it is clear that further
placebo-controlled clinical trials are mandatory to verify positive effects and to
monitor long term safety when somatropin is administered as an agent in the
treatment of CHF.
17
PMID: 18031179 [PubMed]
C. TREATMENT WITH TESTOSTERONE AND RELATED ANABOLIC STEROIDS WAS
MEDICALLY NECESSARY
The use of testosterone and related anabolic steroids when added to human growth
hormone improved cardiac performance in the Petitioner. This improvement is similar to the
improvement that professional athletes such as Ben Johnson (Olympic gold metal 1988) and
Mark McGuire and others have demonstrated, when treated with similar medications as
Petitioner.
Because the addition of anabolic steroids “improved clinical symptoms, exercise
capacity, and the patients' quality of life” and was “considered clinically effective for his illness”
as well as meeting the “generally accepted standards of medical practice,” based on “credible
scientific evidence published in numerous peer reviewed journals”, treatment with
testosterone and related anabolic steroids was “medically necessary”, in accordance with the
Love Consent Court Order. The following references, including the abstract for each
reference, support the use of such a clinical course of therapy as provided to Petitioner by Dr.
Lichten.
Caminiti G, Volterrani M, Iellamo F, et al. Effect of long-acting testosterone treatment on
functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex
sensitivity in elderly patients with chronic heart failure. Journal of the American College of
Cardiology 2009; 54(10): 919-927. The study indicated:
This 12-week, double-blind, placebo-controlled, randomized study evaluated the
effect of long-acting testosterone treatment in elderly men with stable chronic
heart failure (CHF). Seventy patients (median age 70 years) were recruited and
randomized 1:1 to receive intramuscular Nebido® manufactured by Bayer
Pharmaceuticals, Inc. or intramuscular saline at 6 week intervals. The baseline
18
characteristics of testosterone and placebo groups were well balanced, and
approximately one-third of patients in each group had hypogonadism. The study
found that 12 weeks of testosterone treatment provided significant
improvements from baseline in skeletal muscle function, cardio-respiratory
indices and insulin resistance (HOMA-IR) that were not seen in the placebo
group (Table). Furthermore, the improvements in VO2 (a measure of physical
fitness) and MVC (a measure of skeletal muscle strength) were dosedependent, i.e. the higher the change in testosterone levels, the greater the
improvement. Patients were already on comprehensive therapy for heart failure,
and testosterone treatment was well tolerated in these frail patients, many of
whom were on multiple concomitant medications.”
Malkin CJ, Channer KS, Jones TH. Testosterone and heart failure. Current Opinion in
Endocrinology, Diabetes and Obesity. 2010 Jun;17(3):262-8. Review. PMID: 20404724.
PMID: 20404724. The abstract provided:
PURPOSE OF REVIEW: Chronic heart failure (CHF) is a common condition
with significant morbidity despite optimal medical therapy. Standard therapy
involves inhibiting the maladaptive changes of metabolism and neuro-hormones
that characterize the syndrome of CHF. Anabolic deficiency is a major
component of the CHF syndrome and testosterone replacement therapy has
been subject to recent trials.
RECENT FINDINGS: The recent literature shows that physiological testosterone
replacement therapy leads to modest improvements in voluntary muscle
strength, lean muscle mass, endurance and positive effects on neuro-muscular
and baro-receptor reflexes. Long-term efficacy and safety remain unstudied at
present.
SUMMARY: Testosterone replacement therapy appears to improve metabolism
and endurance in patients with CHF; further trials will be necessary before
widespread use. Physicians who regularly treat patients with CHF may consider
testosterone therapy but it is likely that they will require the advice and support
from endocrine specialists.
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS,
Montori VM; Task Force, Endocrine Society. Testosterone therapy in men with androgen
deficiency syndromes: an Endocrine Society clinical practice guideline. Journal of Clinical
Endocrinology and Metabolism. 2010 Jun;95(6):2536-59. PMID: 20525905. The abstract
19
provided:
OBJECTIVE: Our objective was to update the guidelines for the evaluation and
treatment of androgen deficiency syndromes in adult men published previously
in 2006.
PARTICIPANTS: The Task Force was composed of a chair, selected by the
Clinical Guidelines Subcommittee of The Endocrine Society, five additional
experts, a methodologist, and a medical writer. The Task Force received no
corporate funding or remuneration.
CONCLUSIONS: We recommend making a diagnosis of androgen deficiency
only in men with consistent symptoms and signs and unequivocally low serum
testosterone levels. We suggest the measurement of morning total testosterone
level by a reliable assay as the initial diagnostic test. We recommend
confirmation of the diagnosis by repeating the measurement of morning total
testosterone and, in some men in whom total testosterone is near the lower limit
of normal or in whom SHBG abnormality is suspected by measurement of free
or bioavailable testosterone level, using validated assays. We recommend
testosterone therapy for men with symptomatic androgen deficiency to induce
and maintain secondary sex characteristics and to improve their sexual function,
sense of well-being, muscle mass and strength, and bone mineral density. We
recommend against starting testosterone therapy in patients with breast or
prostate cancer, a palpable prostate nodule or induration or prostate-specific
antigen greater than 4 ng/ml or greater than 3 ng/ml in men at high risk for
prostate cancer such as African-Americans or men with first-degree relatives
with prostate cancer without further urological evaluation, hematocrit greater
than 50%, untreated severe obstructive sleep apnea, severe lower urinary tract
symptoms with International Prostate Symptom Score above 19, or uncontrolled
or poorly controlled heart failure. When testosterone therapy is instituted, we
suggest aiming at achieving testosterone levels during treatment in the midnormal range with any of the approved formulations, chosen on the basis of the
patient's preference, consideration of pharmacokinetics, treatment burden, and
cost. Men receiving testosterone therapy should be monitored using a
standardized plan.
Jankowska EA, Drohomirecka A, Ponikowska B, Witkowska A, Lopuszanska M,
Szklarska A, Borodulin-Nadzieja L, Banasiak W, Poole-Wilson PA, Ponikowski P.
Deficiencies in circulating testosterone and dehydroepiandrosterone sulphate, and
depression in men with systolic chronic heart failure. European Journal of Heart
Failure. 2010 Sep;12(9):966-73 PMID: 20595194. The abstract provided:
20
AIMS: Elderly men with androgen deficiencies are prone to develop late-onset
depression. We investigated links between circulating androgens and
depression, and their combined impact on outcome in men with chronic heart
failure (CHF).
METHODS AND RESULTS: Serum total testosterone (TT) and
dehydroepiandrosterone sulphate (DHEAS) were measured using
immunoassays in 163 men with stable systolic CHF [age: 60 +/- 10 years, NYHA
class (I/II/III/IV): 27/84/46/6] and 316 healthy men. Depression was assessed
using Beck Depression Inventory (BDI) and defined as BDI > or =16 points. In
men with CHF, reduced TT and DHEAS, advanced NYHA class, elevated Nterminal pro-B type natriuretic peptide (NT-proBNP), reduced glomerular
filtration rate, and reduced haemoglobin independently predicted severity of
depressive symptoms (all P < 0.05). Depression was present in 20, 37 and 77%
of men with no androgen deficiency, either TT or DHEAS deficiency, and both
androgen deficiencies, respectively (P < 0.0001). During follow-up (median: 28
months), there were 87 (53%) cardiovascular deaths or unplanned
hospitalizations. TT and DHEAS deficiencies (defined as < or = the 10th
percentile of serum androgen levels in healthy controls) and BDI > or =16 points
independently predicted unfavourable outcome (all P < 0.05).
CONCLUSION: TT and DHEAS deficiencies predict severity of depression in
men with CHF. Depression and combined androgen deficiencies are
independently related to poor outcome in these patients.
Jones TH. Testosterone deficiency: a risk factor for cardiovascular disease? Trends
Endocrinology and Metabolism. 2010 Aug;21(8):496-503. Epub 2010 Apr 8. PMID:
20381374. The abstract provided:
PURPOSE OF REVIEW: Chronic heart failure (CHF) is a common condition
with significant morbidity despite optimal medical therapy. Standard therapy
involves inhibiting the maladaptive changes of metabolism and neuro-hormones
that characterize the syndrome of CHF. Anabolic deficiency is a major
component of the CHF syndrome and testosterone replacement therapy has
been subject to recent trials.
RECENT FINDINGS: The recent literature shows that physiological
testosterone replacement therapy leads to modest improvements in voluntary
muscle strength, lean muscle mass, endurance and positive effects on neuromuscular and baro-receptor reflexes. Long-term efficacy and safety remain
unstudied at present.
SUMMARY: Testosterone replacement therapy appears to improve metabolism
and endurance in patients with CHF; further trials will be necessary before
21
widespread use. Physicians who regularly treat patients with CHF may consider
testosterone therapy but it is likely that they will require the advice and support
from endocrine specialists.
Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement
therapy: a review. Therapeutics and Clinical Risk Management. 2009 Jun;5(3):427-48. Epub
2009 Jun 22. PMID: 19707253. The abstract provided:
Increased longevity and population aging will increase the number of men
with late onset hypogonadism. It is a common condition, but often underdiagnosed and undertreated. The indication of testosterone-replacement therapy
(TRT) treatment requires the presence of low testosterone level, and symptoms
and signs of hypogonadism. Although controversy remains regarding indications
for testosterone supplementation in aging men due to lack of large-scale, longterm studies assessing the benefits and risks of testosterone-replacement
therapy in men, reports indicate that TRT may produce a wide range of benefits
for men with hypogonadism that include improvement in libido and sexual
function, bone density, muscle mass, body composition, mood, erythropoiesis,
cognition, quality of life and cardiovascular disease. Perhaps the most
controversial area is the issue of risk, especially possible stimulation of prostate
cancer by testosterone, even though no evidence to support this risk exists. Other
possible risks include worsening symptoms of benign prostatic hypertrophy, liver
toxicity, hyperviscosity, erythrocytosis, worsening untreated sleep apnea or
severe heart failure. Despite this controversy, testosterone supplementation in the
United States has increased substantially over the past several years. The
physician should discuss with the patient the potential benefits and risks of TRT.
The purpose of this review is to discuss what is known and not known regarding
the benefits and risks of TRT
The use of Stanozolol is indicated for Petitioner's condition because it is effective at
reducing Sex Hormone Binding Globulin, a new marker of disease severity and prognosis in
men with chronic heart failure. This is supported by credible scientific evidence, published in
the following peer reviewed publications, with the abstracts included: Pascual-Figal DA,
Tornel PL, Nicolás F, Sánchez-Más J, Martínez MD, Gracia MR, Garrido IP, Ruipérez JA,
Valdés M. Sex hormone-binding globulin: a new marker of disease severity and prognosis in
men with chronic heart failure. Revisa Espanol de Cardiologia. 2009 Dec;62(12):1381-7
PMID: 20038404
22
INTRODUCTION AND OBJECTIVES: Sex hormone-binding globulin (SHBG) is
a key regulator of the actions of anabolic steroids. Chronic heart failure (HF) has
been associated with anabolic steroid deficiency, but its relationship with SHBG
is not known.
METHODS: The study involved 104 men (53+/-11 years) with HF (i.e. left
ventricular ejection fraction [LVEF] <40%) attending a specialist clinic on
optimum treatment and in a stable condition. At enrolment, the median and
interquartile range (IQR) SHBG level was determined, associated hormone
levels were measured, and known risk factors were recorded. The study endpoint was cardiac death within 3 years.
RESULTS: At enrolment, the SHBG level (median 34.5 nmol/L, IQR 27-50
nmol/L) was correlated with the N-terminal probrain natriuretic peptide level
(r=0.271, P=.005), LVEF (r=-0.263, P=.007), body mass index (r=-0.199,
P=.020) and total testosterone level (r=0.332, P=.001). The median SHBG level
was higher in the 16 patients (15.4%) who died, at 48.5 nmol/L (IQR 36-69.5
nmol/L) vs. 33 nmol/L (IQR 25.3-48.7 nmol/L; P=.001), and a high level was
associated with an increased risk of death (hazard ratio [HR]=1.045, 95%
confidence interval [CI] 1.021-1.069; P< .001). The association remained
significant after adjustment in Cox multivariate regression modeling, at
HR=1.049 (95% CI 1.020-1.079; P=.001). Analysis by SHBG tertiles showed
mortality was 30% in the third tertile, 14% in the second, and 4% in the first (log
rank 0.007; HR=3.25, 95% CI 1.43-7.34; P=.004).
CONCLUSIONS: The SHBG level correlated with measures of HF severity and
was associated with a higher risk of cardiac death. Further studies are needed
to clarify whether SHBG plays a role in HF pathophysiology.
Krause A, Sinnecker GH, Hiort O, Thamm B, Hoepffner W. Applicability of the SHBG
androgen sensitivity test in the differential diagnosis of 46,XY gonadal dysgenesis, true
hermaphroditism, and androgen insensitivity syndrome. Experimental Clinical Endocrinology
and Diabetes. 2004 May;112(5):236-40.PMID: 15146368
The sex hormone-binding globulin (SHBG) androgen sensitivity test has been
used as a simple method to assess androgen receptor function in vivo. After a
short term oral administration of the anabolic-androgenic steroid stanozolol the
mean nadir serum concentration of SHBG is used as a measure of androgen
response. We performed this test in order to evaluate its applicability in 16
patients with intersexual genital status: eleven with 46,XY gonadal dysgenesis
and three with true hermaphroditism (group I), and in two patients with
23
androgen insensitivity syndrome (AIS, group II). Ten healthy adult volunteers
served as controls. In the two patients with AIS (group II) we found a diminished
decrease of serum SHBG to 80.1 % and 80.7 %, respectively, indicating slight
residual androgen responsiveness. In eleven patients of group I who were not on
hormone replacement therapy, a mean nadir level of 51.7 +/- 8.7 % was found.
In the controls the mean nadir serum SHBG level was significantly higher (62.7
+/- 5.2 %), probably due to interference of endogenous androgens and
contraceptive medication with the stanozolol-induced SHBG decrease. In three
gonadectomised patients who were on hormone replacement therapy the initial
SHBG concentration was increased (513.5 +/- 239.1 nmol/l); the mean nadir
SHBG concentration of 45.6 +/- 9.8 % of the initial level indicates an increased
sensitivity of the test in patients in whom the counteracting ovarian androgens
are absent. Our findings confirm that under standard test conditions the SHBG
androgen sensitivity test is a simple diagnostic tool for the detection of androgen
receptor malfunction.
Nandrolone does not have negative effects on heart function as indicated by the
following credible scientific, published in the following peer reviewed publication: Hartgens F,
Cheriex EC, Kuipers H. Prospective echocardiographic assessment of androgenic-anabolic
steroids effects on cardiac structure and function in strength athletes. Int J Sports Med. 2003
Jul;24(5):344-51. PMID: 12868045. The abstract provided:
Since the abuse of androgenic-anabolic steroids (AAS) has been associated
with the occurrence of serious cardiovascular disease in young athletes, we
performed two studies to investigate the effects of short-term AAS
administration on heart structure and function in experienced male strength
athletes, with special reference to dose and duration of drug abuse. In Study 1
the effects of AAS were assessed in 17 experienced male strength athletes (age
31 +/- 7 y) who self-administered AAS for 8 or 12 - 16 weeks and in 15 nonusing strength athletes (age 33 +/- 5 y) in a non-blinded design. In Study 2 the
effects of administration of nandrolone decanoate (200 mg/wk i. m.) for eight
weeks were investigated in 16 bodybuilders in a randomised double blind,
placebo controlled design. In all subjects M-mode and two-dimensional Dopplerechocardiography were performed at baseline and after 8 weeks AAS
administration. In the athletes of Study 1 who used AAS for 12 - 16 weeks a
third echocardiogram was also made at the end of the AAS administration
period. Echocardiographic examinations included the determination of the aortic
diameter (AD), left atrium diameter (LA), left ventricular end diastolic diameter
(LVEDD), interventricular septum thickness (IVS), posterior wall end diastolic
wall thickness (PWEDWT), left ventricular mass (LVM), left ventricular mass
index (LVMI), ejection fraction (EF) and right ventricular diameter (RVD). For
assessment of the diastolic function measurements of E and A peak velocities
and calculation of E/A ratio were used. In addition, acceleration and
24
deceleration times of the E-top (ATM and DT, respectively) were determined.
For evaluation of factors associated with stroke volume the aorta peak flow (AV)
and left ventricular ejection times (LVET) were determined. In Study 1 eight
weeks AAS self-administration did not result in changes of blood pressure or
cardiac size and function. Additionally, duration of AAS self-administration did
not have any impact on these parameters. Study 2 revealed that eight weeks
administration of nandrolone decanoate did not induce significant alterations in
blood pressure and heart morphology and function. Short-term administration of
AAS for periods up to 16 weeks did not lead to detectable echocardiographic
alterations of heart morphology and systolic and diastolic function in
experienced strength athletes. The administration regimen used nor the length
of AAS abuse did influence the results. Moreover, it is concluded that
echocardiographic evaluation may provide incomplete assessment of the actual
cardiac condition in AAS users since it is not sensitive enough to detect
alterations at the cellular level. Nevertheless, from the present study no
conclusions can be drawn of the cardiotoxic effects of long term AAS abuse.
Nandrolone, another treatment Petitioner underwent, acts similarly to testosterone but
cannot be aromatized to estrogen. Nandrolone does not promote polycythemia as much as
testosterone, as the following. This is established by the following credible scientific
evidence, published in the following peer reviewed publication: Gorshein D, Murphy S,
Gardner FH. Comparative study on the erythropoietic effects of androgens and their mode of
action. Journal Applied Physiology. 1973 Sep;35(3):276-8. PMID: 4732322
D. Treatment with carnitor was medically necessary.
Carnitor: Carnitine replacement is an appropriate treatment in mitochondrial disease,
including cardiomyopathy, as indicated by the following credible scientific, published in the
following peer reviewed publication followed by the abstract: Angelini C, Federico A,
Reichmann H, Lombes A, Chinnery P, Turnbull D. Task force guidelines handbook: EFNS
guidelines on diagnosis and management of fatty acid mitochondrial disorders. European
Journal of Neurology. 2006 Sep;13(9):923-9. PMID: 16930355
Guidelines in the diagnosis and current dietary treatment of long-chain fatty acid
(LCFA) defects have been collected according to evidence-based medicine.
Since the identification of carnitine and carnitine palmitoyltransferase deficiency
more than 25 years ago, nearly every enzymatic step required for beta25
oxidation has been associated with an inherited metabolic disorder. These
disorders effectively preclude the use of body fat as an energy source. Clinical
consequences can range from no symptoms to severe manifestations including
cardiomyopathy, hypoglycaemia, peripheral neuropathy and sudden death. A
diet high in carbohydrates, diet with medium-chain triglycerides and reduced
amount of LCFA has a beneficial effect (class IV evidence) and in appropriate
deficiency states carnitine and riboflavin are used (good practice points).
Therefore, all of the medications, drugs, and other substances prescribed or used by
Dr. Lichten, during the course of treatment for Petitioner were medically necessary.
II. THE RECORD OF OFIR SUPPORTS A DECISION BY THIS COURT TO ORDER
APPELLEE TO PAY PETITIONER FOR THE SERVICES THAT WERE DENIED BY
BCBMS.
The record contains enough of the references that satisfy the requirements of “medical
necessity” as argued more fully herein, so that this Court can Order the payment for the
medical services in dispute.
RELIEF REQUESTED
Petitioner respectfully requests that this Court order BCBSM to pay Petitioner for the
services that were denied by BCBSM. In addition, Petitioner requests that this Court order the
Commissioner of OFIR to henceforth abide by the Federal Order stipulated to by BCBSM, 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.
Petitioner respectfully requests that the Court order BCBSM and OFIR to process
claims in a timely manner in accordance with LOVE vs. BCBS Association and with MCL
550.1211 a et seq and all other applicable state and federal laws and regulations. Petitioner
respectfully requests that the Court order BCBSM to cease and desist in all actions that
violate the aforementioned laws.
Specifically, Petitioner respectfully, request that the court order BCBSM to amend their
26
contracts to reflect the Love Court Order.
CONCLUSION
Petitioner respectfully requests that for all the reasons stated above, Petitioner be
granted the relief requested herein.
Date: November 15, 2010
Respectfully submitted,
_______________________________,
Martin H. Leaf
Attorney for Petitioner
27