Re: Because of IHMA Congress members Have Introduced HR 7299. Legislation will Force VA and TRICARE to pay for HBOT 1.5 fo r Veterans

[Guest guest]

The below report was delivered to the AG of New Mexico at his request.

KP Stoller, MD

President, International Hyperbaric Medical Assoc

Medical Director, Hyperbaric Medical Center of New Mexico

www.hbotnm.com

Report to Attorney General King

HSD “Fair Hearings” are far from Fair in New Mexico

Prepared by: KP Stoller, MD at the request of AG King

Request

To either remove control of the Medicaid Fair Hearing process form HSD (which

may be a legislative matter), require HSD to apply the letter of the Federal

Medicaid law to their decisions in the Fair Hearing process and/or require

oversight of these decisions by the AGs office. Right now there is an endemic

disregard for the rights of Medicaid recipients under EPSDT here in New Mexico

and elsewhere. Without oversight, HOs often distort both case law and

cherry-pick testimony to favor NM HSD and MCO surrogates:

I. BACKGROUND

When a Medicaid recipient is denied and drug, therapy or procedure by NM (HSD)

Medicaid or an MCO surrogate, such as Lovelace Salud, Molina Salud or Pres

Salud, they can request a Fair Hearing. HOs are employees of HSD and their

decisions must be approved by the Director of the Medical Assistance Division

(MAD). This is akin to two foxes watching the hen house. A poor family, when it

loses at a Fair Hearing has no recourse but to file in District Court, and this

requires resources far beyond what can be expected of a family on Medicaid. For

practical purposes the process stops after the so called Fair Hearing. Few

families can muster the needed resources to even get to a Fair Hearing where the

HOs often request the family have a lawyer, because the MCO has one present.

I have already approached the Medicaid Fraud Division of the AGs office to

complain, not about the inherent unfairness of the system, but because of the

gross misapplication of EPSDT law which then denies Medicaid recipients their

rights. Families are most often put into the position of providing evidence that

a therapy or procedure will correct or ameliorate their child, when it is NM HSD

(or MCO) that has the burden of proof that said intervention will not correct or

ameliorate. Previously, I was told that this is a matter for the legislature and

that is simply not a situation the Medicaid Fraud Division is set up to address.

I am writing this report at the request of AG King after my meeting with

him on 11/21/08, wherein I discussed the above. Several families in my medical

practice have gone so far as to file complaints with the Office of Civil Rights

(HHS) because of egregious decisions made at Fair Hearings. I can make these

families available to the AG’s office upon request.

II. RATIONALE

What the Medicaid Act Requires HSD to cover.

The Early and Periodic Screening, Diagnostic, and Treatment (“EPSDT”) service is

Medicaid's comprehensive child health program designed to assure the

availability and accessibility of health care resources for the treatment,

correction and amelioration of the unhealthful conditions of individual Medicaid

recipients under the age of 21. CMS State Medicaid Manual § 5010.B. A principal

goal of the EPSDT program is “to assure that health problems are diagnosed and

treated early, before they become more complex and their treatment more costly.”

Id. Accordingly, the Medicaid Act provides for a broad range of services for

EPSDT recipients. See 42 U.S.C. § 1396d (a)(xiii)(1) through (28) (setting out

categories of covered EPSDT services); 42 U.S.C. § 1396d (a)(xiii)(13)

(“diagnostic, screening, preventive, and rehabilitative services, including any

medical or remedial services . . . for the maximum reduction of physical or

mental disability and restoration of an individual to the best possible

functional level.”).

NM HSD and their MCO surrogates are obliged to cover the “delivery of the

federally mandated early and periodic screening, diagnostic and treatment

(EPSDT) services provided by a PCP [primary care provider] and physical or

behavioral health specialist.” NMAC 8.305.7.11.Q. NM HSD and their MCO

surrogates must cover prevention, screening, diagnostic, ameliorative services,

and other medically necessary services as identified by a licensed health care

provider. See also NMAC 8.305.6.12.A (4) (providing that the MCO “shall develop

policies and procedures to ensure that children under age 21 are provided EPDT

services by their primary care provider or in another manner”). The New Mexico

Annotated Code defines medically necessary services as “clinical and

rehabilitative physical or behavioral health services that: (i) are essential to

prevent, diagnose or treat medical conditions or are essential to enable the

individual to attain, maintain or regain functional capacity.” NMAC

8.305.1.7.M.7 (a).

While there is no federal definition of preventive medical necessity, federal

amount, duration and scope rules require that coverage limits must be sufficient

to ensure that the purpose of a benefit can be reasonably achieved.... Since the

purpose of EPSDT is to prevent the onset of worsening of disability and illness

and children, the standard of coverage is necessarily broad... the standard of

medical necessity used by a state must be one that ensures a sufficient level of

coverage to not merely treat an already-existing illness or injury but also, to

prevent the development or worsening of conditions, illnesses, and disabilities.

See U.S. Department of Health and Human Services, Health Resources and Services

Administration at: http://www.hrsa.gov/epsdt/medical.htm

Although state participation in the Medicaid program is voluntary, once a state

chooses to join, it must comply with the Medicaid Act and its implementing

regulations. See Amisub v. Colorado Dep’t Social Services, 879 F.2d 789, 794

(10th Cir. 1989); 42 U.S.C. § 1396d (a)(4)(. Pursuant to the Medicaid Act at

42 U.S.C. § 1396d ® (5), Therefore, NM HSD and their MCO surrogates are

required to cover treatment that is necessary to correct or ameliorate the

condition of qualified EPSDT recipients, “whether or not such services are

covered under the state plan.” (Emphasis added). Similarly, NMAC 8.320.2.9

provides that through the EPSDT program, Medicaid pays for “prevention,

treatment and ameliorative services[.]”

As the Fifth Circuit explained in S.D. ex rel Dickson v. Hood, 391 F.3d 581, 591

(5th Cir. 2004), CMS interprets the Medicaid Act to allow a state Medicaid

agency to fix or adjust the scope of services provided under the EPSDT benefit

only if such regulation comports with the Medicaid Act by covering all services

necessary to ameliorate or correct a condition. Id. (citing 42 C.F.R. 440.230);

Id. at 589-591 (discussing legislative history surrounding 1989 amendment to

Medicaid Act, imposing mandatory duty upon participating states to provide

EPSDT-eligible children with all the health care, services, treatments and other

measures necessary to correct or ameliorate health problems, regardless of

whether the applicable state plan covers such services); Id. at FN 7 (citing

State Medicaid Manual at § 5122 (interpreting 42 CFR 440.230)). See also Pittman

v. Secretary, Florida Dep’t of Health and Rehab. Servs., 998 F.2d 887, 889 (11th

Cir. 1993). Accord Pediatric Specialty Care, Inc. v. Arkansas Dep’t of Human

Servs., 293 F.3d 472, 480-81 (8th Cir. 2002) (providing that provision of early

intervention day treatment was required under EPSDT, regardless of whether the

state plan covered such services).

NM HSD (and their MCO surrogates) reject FDA approved treatments for handicapped

children on a regular basis citing that they are Experimental and

Investigational.

NM HSD and their MCO surrogates typically cite treatments for children with

cerebral palsy, autism, encephalopathies and other neurological disorders are

“experimental or investigational,” pursuant to NMAC 8.325.6.12. when treatments

are “off-label.” The use of off-label treatment is particularly common in

pediatrics, and is not the same thing as “experimental or investigational.”

Pursuant to NMAC 8.325.6.12.A, a treatment may be considered experimental or

investigational if “further studies or clinical trials are necessary to

determine benefits, safety, efficacy and risks, especially as compared with

standard or established methods or alternatives for diagnosis and/or treatment

outside an investigational seting.” Id. (Emphasis added). The “standard”

treatments in, for example, autism, such as occupational therapy and behavioral

modification are supported primarily by pilot studies and clinically-based

medicine, rather than by published, peer reviewed double blind studies.

Nearly all of the already-approved indications would be deemed investigational

or experimental. While double blind, placebo-controlled trials are the ‘gold

standard’ for government regulators overseeing the approval of new

pharmaceuticals, but not for clinical decision making or for insurance coverage

decisions. Evidence-based clinical decisions rely more heavily on comparisons of

a treatment to other potentially effective therapies than to placebos.

In the case of cerebral palsy, double blind, evidence based studies have been

presented to Hearing Officers. One of my patients even had the Senior Clinician

on a double blind study testify on their behalf. What the expert testified to

under oath did not resemble what the HO stated the expert had said. The HO said

this international expert said the results were equivocal, when he in fact

testified that the results were significantly favorable.

Medicare NCDs are Irrelevant to the Mandatory Provision of EPSDT Benefits.

NM HSD often argues that that they do not need to cover certain services if the

Medicare Coverage Database does not list the relevant condition as coverable.

NMAC 8.301.3.30 provides that “Medicaid does not cover certain services,

procedures, or devices that are not covered by [M]edicare due to their

determination that the service, procedure or device is ineffective or of

questionable efficacy.” (Emphasis added). NM HSD over simplifies and distorts

the NMAC provision and uses it against children. You see, Medicare will never

make a determination that a drug, therapy, or procedure is either ineffective or

of questionable efficacy, effective or efficacious for a condition that is not

relevant to a population that is not 65 years old or older. You will never see

CP, or Autism , or Fetal Alcohol Syndrome listed in a Medicare Coverage

Database.

As the Fifth Circuit explained in S.D. ex rel Dickson v. Hood, 391 F.3d 581 (5th

Cir. 2004), Medicare coverage criteria is “completely irrelevant” to the issue

of EPSDT coverage. Id. at 598-599 and FN 20 (Emphasis added). The “benefits

provided under the two programs are not comparable and Medicare, unlike

Medicaid, does not provide for the EPSDT program.” Id. at 599. Given that

Medicare and Medicaid/EPSDT are separate programs dealing with separate

populations, Medicare coverage determinations are simply not relevant to EPSDT

issues.

NM HSD has the burden to demonstrate that if they decline to cover a drug,

therapy or procedure that they have done so based on evidence that it would not

correct or ameliorate his condition. Further, it is not the Medicaid recepient’s

burden to provide scientific evidence establishing the efficacy of the drug,

therapy or procedure that is being denied coverage.

EPSDT is a comprehensive child health program designed to assure the

availability and accessibility of health care resources for the treatment,

correction and amelioration of the unhealthful conditions of individual Medicaid

recipients under the age of twenty-one. CMS State Medicaid Manual § 5010.B.

EPSDT is a unique program, in that its principal goal is one of “assur[ing] that

health problems are diagnosed and treated early, before they become more complex

and their treatment more costly.” Id. Accordingly, the Medicaid Act provides for

a broad range of services for EPSDT recipients. See 42 U.S.C. § 1396d

(a)(xiii)(1) through (28) (setting out categories of covered EPSDT services); 42

U.S.C. § 1396d (a)(xiii)(13) (“diagnostic, screening, preventive, and

rehabilitative services, including any medical or remedial services . . . for

the maximum reduction of physical or mental disability and restoration of an

individual to the best possible functional level.”).

NM HSD is obliged to cover the “delivery of the federally mandated early and

periodic screening, diagnostic and treatment (EPSDT) services provided by a PCP

[primary care provider] and physical or behavioral health specialist.” NMAC

8.305.7.11.Q. NM HSD must cover prevention, screening, diagnostic, ameliorative

services, and other medically necessary services as identified by a licensed

health care provider. See also NMAC 8.305.6.12.A (4) (providing that the MCO

“shall develop policies and procedures to ensure that children under age 21 are

provided EPSDT services by their primary care provider or in another manner”).

“The natural reading of § 1396d ®(5)’s phrase is that all of the health care,

services, treatments and other measures described by § 1396d (a) must be

provided by state Medicaid agencies when necessary to correct or ameliorate

unhealthful conditions discovered by screening, regardless of whether they are

covered by the state plan.” S.D. v. Hood, 391 F.3d 581, 589 (5th Cir. 2004)

(citations omitted). NM HSD can not argue that a drug, therapy or procedure

would be experimental, merely because a patient has been given a diagnosis for

which an intervention is not normally used NMAC 8.325.6.12.A (defining

experimental or investigational interventions). It does not provide that

coverage may be denied for a particular condition, merely because an individual

has received a particular diagnosis. Id. See also NMAC 8.305.1.7.M.7 ((iii)

(providing that services may not be denied solely because of prognosis or

diagnosis).

NMAC 8.325.6.12.A’s definition of “experimental or investigational” also states

that such a determination shall be made in comparison with “standard or

established methods or alternatives for diagnosis and/or treatment outside an

investigational setting.” Many of the children in my practice who go before Fair

Hearings are considered medically at risk. “Medically at risk” is defined as

those individuals who have a diagnosed physical or behavioral health condition,

which has a high probability of impairing their cognitive, emotional,

neurological, social, behavioral or physical development. NMAC 8.305.7.11.E

(6).

The NM HSD Fair Hearing practices may well run afoul of regulations

accompanying the American with Disabilities Act (ADA) that bar public entities

like NM Medicaid (and their proxy MCOs) from practices that deny persons the

benefit of its services or programs because of their disability.

Respectfully Submitted,

Stoller, MD,

November 24, 2008

404 Brunn School Rd #D

Santa Fe, NM, 87505

____________________________________________________________

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