No.   97-51094

_________________________

 

IN THE
UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT

_______________________________________________________

 

FRED C., Individually and by and through
his next friend, Evelyn Tattini,

 

Plaintiff-Appellee,    

vs.

 

TEXAS HEALTH AND HUMAN
  SERVICES COMMISSION, ET AL.,

 

Defendants-Appellants.    

_______________________________________________________

 

On Appeal from the United States District Court
for the Western District of Texas
San Antonio Division

_________________________

 

BRIEF OF AMICUS CURIAE,
ASSOCIATION OF TECH ACT PROJECTS

_________________________

 

Steven P. Elliot
Minnesota Attorney Identification No. 249312
Minnesota Disability Law Center
430 First Avenue, Suite 300
Minneapolis, Minnesota  55401-1780
612/332-1441

 

ATTORNEY FOR AMICUS CURIAE
June 19, 1998

 



INTEREST OF AMICUS

            Amicus Curiae, Association of Tech Act Projects, is the national association of state assistive technology projects, which have been designated by the nation's governors pursuant to the Technology Related Assistance for Individuals with Disabilities Act, 29 U.S.C. § 2201 et. seq.  Amicus Curiae's members are state-government agencies and not-for-profit organizations whose statutorily defined mission is to expand national awareness of, funding for and use of assistive technology devices and assistive technology services by people with severe disabilities.  The augmentative communication device sought by Plaintiff-Appellee Fred C. is an example of an assistive technology device.

            A central focus of the Assistive Technology (AT) projects' mission is the identification and creation of assistive technology access and funding opportunities and the removal of access and funding barriers within programs of "cooperative federalism."  In these programs, the federal government, by statute, regulation and other guidance, sets national goals and administrative policies and provides a percentage of program funding, while day-to-day program administration and the remainder of the funding obligations are state and/or local responsibilities.  Medicaid, 42 U.S.C. § 1396 et seq., special education, 20 U.S.C. § 1400 et seq., and vocational rehabilitation, 29 U.S.C. § 701 et seq., are all examples of cooperative federalism programs, and all are programs to which Congress has required the assistive technology projects to direct their efforts.  In response, in every state, the AT projects serve as educators for and policy advocates with their state Medicaid program administrators to develop appropriate assistive technology policies and to remove unwarranted and unnecessary assistive technology barriers.  With these policies in place and barriers removed, people with severe disabilities can achieve the Tech Act's congressional goals of full productivity and full participation in society.  The Association of Tech Act Projects requested and received the consent of the parties to participate as amicus curiae.  Addendum 1.


TABLE OF CONTENTS

 

 

INTEREST OF AMICUS       

TABLE OF CONTENTS       

TABLE OF AUTHORITIES   

SUMMARY OF ARGUMENT          

ARGUMENT 

I.          MEDICAL NEED IS THE PRIMARY FACTOR USED

THROUGHOUT THE COUNTRY TO DETERMINE

WHETHER A SPECIFIC TREATMENT IS WITHIN THE

SCOPE OF A COVERED MEDICAID SERVICE.   

II.         THE MEDICAL NEED-FOCUSED DECISION-MAKING

ANALYSIS OFFERS STATES WIDE, BUT NOT TOTAL,

DISCRETION OVER COVERAGE OF SPECIFIC

TYPES OF TREATMENT.    

A.        Medicaid Services Are Not Covered, As Medically

Necessary, Simply Because A Physician Prescribes Them.       

            1.         Courts require deference to the judgment of the

medical community as a whole rather than to the

treating physician alone.           

            2.         State administrative policies incorporate objective

criteria to assess medical necessity.      

            3.         Medical consultants may be used to review requests

for Medicaid reimbursement.    

B.         State Medicaid Agencies May Control Funding

by Specifying Coverage Procedures and Criteria.         

                        1.         Prior authorization requirements implement

the medical necessity standards.           

2.         Definition by the state Medicaid agency of

the scope of the covered service.         

3.         The state Medicaid agency may establish approval

criteria for specific equipment.  

C.        The Fact That the States, Including Texas, Have Added

Optional Service Categories to Their Medicaid Program,

Demonstrates That Effective Cost Control Measures Are

Already in Place          

CONCLUSION         

ADDENDUM 1

ADDENDUM 2

TABLE OF AUTHORITIES

 

Cases

A.M.L. v. Dept. of Health, 863 P.2d 44 (Utah App. 1993)

Alexander L. v. Cuomo
, 154 Misc.2d 945, 588 N.Y.S.2d 85 (N.Y. Sup. Ct. N.Y. County 1991)

Baker v. Commonwealth of Pa. Dept. of Pub. Welfare, 502 A.2d 318 (Pa. Commw. 1985)

Beal v. Doe, 432 U.S. 438 (1977)

Bowers v. Thompson; No. 89-2-00553-8 (Wash. Super. Ct. Thurston County Oct 15, 1990)

Brisson v. Dept. of Soc. Welfare, 702 A.2d 405 (Vt. 1997)

Bristol v. R.I. Dept. of Human Servs., C.A. No. 95-6605 (R.I. Super.Ct. Jan. 30, 1997)

Curtis v. Taylor, 625 F.2d 645 (5th Cir. 1980)

Davis v. Shrader, 687 N.E.2d 370 (Ind. App. 1997)

DeSario v. Thomas, 139 F.3d 80 (2nd Cir. 1998)

Dexter v. Kirschner, 984 F.2d 979 (9th Cir. 1992)

Doe v. Minn. Dept. of Pub. Welfare, 257 N.W.2d 816 (Minn. 1977)

Ellis v. Patterson, 859 F.2d 52 (8th Cir. 1988)

Fred C. v. Texas Health & Human Servs. Comm'n., 988 F. Supp. 1032 (W.D. Tex. 1997)

Hern v. Beye, 57 F.3d 906 (10th Cir. 1995),       cert. denied, 516 U.S. 1011 (1995)

Hope Medical Group for Women v. Edwards, 63 F.3d 418 (5th Cir. 1995)

Jeneski v. Myers, 163 Cal. App. 3d 18, 209 Cal. Rptr. 178 (1985) cert. denied, 471 U.S. 1136 (1985)

Johnson v. Minn. Dept. of Human Serv., 565 N.W.2d 453 (Minn. App. 1997)

Kirk v. Denning, 370 N.W.2d 113 (Neb. 1985)

Ledet v. Fischer, 638 F. Supp. 1288 (M.D. La. 1986)

Marsh v. Commonwealth, Dept. of Pub. Welfare, 409 A.2d 926 (Pa. Commw. 1979)

McCoy v. Dept. of Health & Welfare, 127 Idaho 972,    907 P.2d 110 (1995)

Meusberger v. Palmer, 900 F.2d 1280 (8th Cir. 1990)

Meyers v. Reagan, 776 F.2d 241 (8th Cir. 1985)

Mitchell v. Johnston, 701 F.2d 337 (5th Cir. 1983)

Morgan v. Dept. of Health & Welfare, 120 Idaho 6, 813 P.2d 345 (Idaho 1991)

Myers v. State of Mississippi, 3:94 CV 185 LN (S.D. Miss. June 23, 1995)

Pinneke v. Preisser, 623 F.2d 546 (8th Cir. 1980)

Preterm, Inc. v. Dukakis, 591 F.2d 121 (1st Cir.), cert. denied,     441 U.S. 952 (1979)

Rickaby v. Wis. Dept. of Health, 297 N.W.2d 36 (Wisc. App. 1980)

Roberts v. Brian, 98 Cal. Rptr. 50, 489 P.2d 1378 (Calif. 1971)

Rush v. Parham, 625 F.2d 1150 (5th Cir. 1980)

Simpson v. Wilson, 480 F. Supp. 97 (D. Vt. 1979)

Visser v. Taylor, 756 F. Supp. 501 (D. Kan. 1990)

Weaver v. Reagen, 886 F.2d 194 (8th Cir. 1989)

White v. Beal, 555 F.2d 1146 (3d Cir. 1977)

Worthington v. Id. Dept. of Health & Welfare, No. 69458 (Idaho D. Ct. 2d Jud. Dist. Nez Perce Co. Feb. 20, 1992)

 

Statutes and Regulations

18 NYCRR § 500.1(b)

18 NYCRR § 505.5(a)(1)

18 NYCRR § 505.5(a)(1)(ii)

18 NYCRR § 505.5(d)(1)(vi)

20 U.S.C. § 1400

22 Cal. Code Regs. § 51321(b) and (f)

22 Cal. Code Regs. § 51521 (Jan. 9, 1968)

25 T.A.C. § 29.301(b)(13)

25 T.A.C. § 29.305(a)(4)

25 T.A.C. § 29.305(a)(4)(C)

25 T.A.C. § 29.305(a)(4)(D)

29 U.S.C. § 2201

29 U.S.C. § 701

42 U.S.C. § 1396

42 U.S.C. § 1396a(a)(17)

42 U.S.C. § 1396a(a)(30)(A)

55 Pa. Code § 1150.63 (c)

55 Pa. Code §§ 1150.63(b) and (d)

Minn. R. 9505.0175, Subp. 10

Minn. R. 9505.0175, Subp. 25, A

Minn. R. 9505.0210

Minn. R. 9505.0310, subp. 4, A

Minn. R. 9505.5030, E

Minn. Stat. § 256B.04, Subd. 15(1)

Minn. Stat. § 256B.0625, Subd. 31a(a)

N.Y. Soc. Serv. Law, § 365-a(1) and (2)

Ohio Administrative Code, §§ 5101:3-1-01(C) & (D)

Oregon Health Plan Admin. Regs., § 410-141-0480 (May 1, 1998)

Tenn. Comp. R. & Reg. § 1200-13-1-.03(ee)(19)              

 

Miscellaneous

Arizona Health Care Cost Containment System (AHCCCS) Medical Policy Manual, § 310 (Oct. 1, 1994)

Georgia Department of Medical Assistance, Policies and Procedures Manual, Part II, Durable Medical Equipment Services, § 806.11 (Apr. 1, 1997)

HCFA Publications

 Kaiser Commission on the Future of Medicaid, Health Needs and Medicaid Financing: State Facts 6 (1995)

Louisiana Dept. of Health & Hospitals, "Prior Authorization for Medical Equipment, Appliances

                and Supplies," Medicaid Eligibility Manual, § 0-201.1 (Aug. 1, 1995)

Maine Medical Assistance Manual, § 60.04-2 (Dec. 24, 1991)

Minnesota Health Care Programs Provider Manual, Chapter 17, page 8, March 1998

Nebraska Department of Social Services Manual, 471 NAC § 7-010.01, Manual Letter # 17-96 (March 18, 1996)

SUMMARY OF ARGUMENT

            The Association of Tech Act Projects submits this brief in support of Plaintiff-Appellee Fred C. and in support of affirmance of the District Court's holding that Texas Medicaid must provide Fred C. with an augmentative communication device (ACD).  The District Court correctly rejected the Texas Medicaid arbitrary barrier to coverage and funding for ACDs based solely on recipient age.

            In this case, the District Court correctly applied a four-step decision-making analysis that has "medical need" as its central focus.  This test requires individuals seeking treatment to establish:

            1)         that s/he is a Medicaid recipient;

            2)         that the characteristics of the treatment being sought match those of one or more covered Medicaid services;

                      3)         that s/he meets any applicable eligibility pre-requisites for the service(s) within which the treatment is classified; and

                      4)         that the treatment being sought is medically necessary.[1]

Because Fred C.'s request for an ACD satisfied each of these criteria, the District Court awarded him summary judgment.

            On appeal, Texas Medicaid claims that Fred C. has failed to satisfy the second criterion.  Texas Medicaid contends that in addition to establishing that the requested treatment meets the criteria for one or more covered Medicaid services, recipients must also show that coverage of the requested treatment is required for Texas Medicaid to meet the needs of "most recipients."  Brief for Appellant at pp. 20-23, 28.

            The Association of Tech Act Projects submits this brief to oppose this so-called "most recipients" standard.  The medical need-focused decision-making analysis applied by the District Court, not the "most recipients" standard proposed by Texas Medicaid, is consistent with Texas Medicaid regulations, the longstanding precedent of this Circuit, the longstanding administration of the Medicaid program by other states, and its historic interpretation by other courts.  Equally significant is that this decision-making analysis offers states wide, but not total, discretion to control access to Medicaid-funded treatment.  Medicaid programs applying this analysis have available and may employ many means to control both access to specific types of treatment and the scope of their Medicaid program obligations.

ARGUMENT

            I.          MEDICAL NEED IS THE PRIMARY FACTOR USED THROUGHOUT THE COUNTRY TO DETERMINE WHETHER A SPECIFIC TREATMENT IS WITHIN THE SCOPE OF A COVERED MEDICAID SERVICE.

            Four inter-related Texas Medicaid regulations, which are consistent with the manner in which Medicaid is administered throughout the country, should have governed the decision-making process when Plaintiff-Appellee Fred C. requested that Texas Medicaid provide funding for a Dynavox, a type of augmentative communication device:

            -25 T.A.C. § 29.301(b)(13) -- defining durable medical equipment (DME);

            - 25 T.A.C. § 29.305(a)(4) -- stating general requirements for DME funding;

            -25 T.A.C. § 29.305(a)(4)(C) -- a non-exclusive list of items which Texas Medicaid has determined to be DME; and

            -25 T.A.C. § 29.305(a)(4)(D) -- stating that access to devices and equipment not previously listed will be provided "when it can be medically substantiated as a part of the [recipient's] treatment plan that such service would serve a specific medical purpose on an individual case basis."

            These regulations make clear that, in Texas, establishing the recipient's specific medical need for an item of durable medical equipment or prosthetic device is the key element of the decision-making process.  This medical need-focused decision-making analysis is common to Medicaid programs throughout the country.  In Louisiana, Medicaid guidelines outline ten criteria that govern the decision-making process for specific types of devices and equipment under the durable medical equipment and prosthetic device benefits, with the key being medical necessity.[2]Louisiana Dept. of Health & Hospitals, "Prior Authorization for Medical Equipment, Appliances and Supplies," Medicaid Eligibility Manual, § 0-201.1 (Aug. 1, 1995).  Mississippi Medicaid also acknowledges that medical necessity is the key element of this decision-making process.[3]A copy of this Stipulation is included in Addendum 2 to this Brief.

            Other states have decision-making standards substantively identical to those  of Texas Medicaid.  E.g., Arizona,[4] California,[5] Georgia,[6] Maine,[7] Minnesota,[8]   Nebraska,[9] New York,[10] Ohio,[11] Oregon,[12] Pennsylvania,[13] and Tennessee[14].

            Courts interpreting the Medicaid Act also recognize a medical-need focused inquiry is appropriate when reviewing disputes involving access to specific types of treatment.  The Supreme Court recognized Congress made medical need the central focus of the Medicaid Act as a whole.  Beal v. Doe.[15]  This observation has been consistently applied by this Circuit in Curtis,[16] Rush,[17] Mitchell[18] and Hope Medical Group for Women,[19] and by the Medicaid decisions of the First Circuit[20], Third Circuit[21], Eighth Circuit[22], Ninth Circuit,[23] and Tenth Circuits.[24]  When viewed as a collective whole, these decisions, along with decisions from the lower federal courts and from state courts, establish a substantial body of precedent supporting the primacy of the medical need standard.

            The general rule has been that for types of treatment that fit the definitions of one or more Medicaid-covered services and that are not experimental in nature it is the recipient's specific medical need that controls whether access to that type of treatment must be provided.  By contrast, it has not mattered how often a specific type of treatment is being sought by other Medicaid recipients, or whether the treatment falls within a required or optional Medicaid service.  As one court noted:  "cost alone, or unique but necessary medical care for Medicaid recipients have not been a bar to Medicaid coverage."[25]

            This statement reflects Medicaid interpretations reached throughout the history of the Medicaid program, across a wide range of Medicaid services -- both required and optional -- and throughout the country.  For example, it has been applied to the Medicaid durable medical equipment and prosthetic device benefit, as in the District Court below,[26] to  physicians'   services,  in- or out-patient hospital services,[27] laboratory and x-ray services,[28] nursing facility services,[29] medical supplies,[30] eyeglasses,[31] dental services,[32] and prescription drugs.[33]

            The synthesis of these varied holdings are general rules stating the "touchstone for evaluating whether a state [Medicaid] plan is reasonable is whether medically necessary procedures are covered"[34] and that "agency policy which does not and cannot respond to medical necessity is arbitrary and capricious."[35]  The application of these rules to the facts of this case is reflected in the District Court's conclusion that "Texas Medicaid's selection of age as the sole criterion for denying benefits is wholly unrelated to the medical decision at hand and cannot meet the fundamental legal concept of reasonableness."[36]

 

1">            II.        THE MEDICAL NEED-FOCUSED DECISION-MAKING ANALYSIS OFFERS STATES WIDE, BUT NOT TOTAL, DISCRETION OVER COVERAGE OF SPECIFIC TYPES OF TREATMENT.

            As this Court acknowledged in Hope Medical Group for Women,[37] Medicaid programs have wide, but not total, discretion with regard to coverage of specific types of treatment.  The medical need-focused standard stated in the Texas Medicaid regulations and in use throughout the United States is wholly consistent with this scope of Medicaid program discretion.  But focusing on medical need does not require Medicaid programs to cover all treatments merely because they are prescribed by a treating doctor.  States have many tools to ensure that Medicaid expenditures reflect professionally as well as fiscally sound judgments.

                        A.        Medicaid Services Are Not Covered, As Medically Necessary, Simply Because A Physician Prescribes Them.

                                    1.         Courts require deference to the judgment of the medical community as a whole rather than to the treating physician alone.

            Services are not deemed to be "medically necessary" services simply because the treating physician has prescribed them.  Contrary to the statement by the Second Circuit in DeSario v. Thomas, 139 F.3d 80, 95-96 (2nd Cir. 1998), decisions of the Eighth Circuit which emphasize deference to the treating physician do not lead to "budgeting by blank check."  Rather, the Eighth Circuit decisions require deference to the judgment of the treating physician when that judgment reflects the judgment of the medical community as a whole.[38]  State court decisions are similarly grounded in deference to the treating physician when the judgment of that physician is consistent with accepted professional standards or when no contrary evidence was presented by the state agency.[39]

                                    2.         State administrative policies incorporate objective criteria to assess medical necessity.

            The state Medicaid agencies have incorporated objective criteria in their definitions of "medical necessity" which limit the possibility that a single physician's order would expand, inappropriately, the scope of a covered service.  For instance, a medically necessary service may be required to "meet accepted standards of medical practice,"[40] be "recognized as the prevailing standard or current practice by the provider's peer group"[41]  be "consistent with quality care and generally accepted professional standards,"[42] or be "consistent with scientifically based guidelines of national medical, research, or health care coverage organizations or government agencies."[43]  Reimbursement must be justified in those terms, not the opinion of the physician alone.

                                    3.         Medical consultants may be used to review requests for Medicaid reimbursement.

            A third check on an order or prescription for funding by a treating physician is that the Medicaid agency may use medical consultants with expertise in the area to review requests for reimbursement.[44]  While these consultants can be and are used to scrutinize requests made by physicians and other health care providers, the applicable standards require them to determine the appropriate medical need for the individual recipient.  Cost containment is not the only issue.

                        B.        State Medicaid Agencies May Control Funding by Specifying Coverage Procedures and Criteria.

            State agencies in accordance with 42 U.S.C. § 1396a(a)(30)(A) must establish methods and procedures for utilization control.  These efforts at cost containment are not inconsistent with the focus of the program on medical need-based decision making.

                                    1.         Prior authorization requirements implement the medical necessity standards.

            Some form of prior authorization requirement is imposed in many states for reimbursement for DME or prosthetics.  These prior authorization standards generally include requirements that medical necessity be established and that the item is the least expensive but yet appropriate item or treatment.[45]  When a dispute arises whether a particular device or piece of equipment should be reimbursed, the question is one of fact to be determined on the basis of medical evidence.[46]

2">                                    2.         Definition by the state Medicaid agency of the scope of the covered service.

            The term "durable medical equipment" is not defined in the federal Medicaid statute or regulations.  A state Medicaid agency, by a reasonable definition of the term, may limit the scope of coverage.  For instance, it may be medically necessary for a person with physical disabilities to have a widened door to a bathroom or a roll-in shower to perform essential hygiene functions.  If, as is often the case, the definition of DME is limited to devices or equipment,[47] these home modifications, however necessary, would not be within the scope of the covered service.  Similarly, many states limit DME to items "primarily and customarily used for medical purposes,"[48] which raises problems in application, but limits the scope of coverage in this category.

2">                                    3.         The state Medicaid agency may establish approval criteria for specific equipment.

            For specific items of equipment, the state Medicaid agency may establish criteria for approval for funding by policy or rule.  For instance, in Minnesota, which has statutory authorization for funding for augmentative communication devices,  Minn. Stat. § 256B.0625, Subd. 31a(a), seven additional requirements for approval of a prior authorization request are incorporated in the state agency's manual.[49] 

            States can and have used other means to limit Medicaid utilization.[50]  Texas Medicaid employs some of these procedures and may elect to utilize them all as well as any others that constitute reasonable standards consistent with the overall goals and purposes of the Medicaid Act.  42 U.S.C. § 1396a(a)(17).  In sum, a medical need-focused decision-making standard provides states with a wide range of options to ensure scarce public funds are spent only when that is consistent with sound professional judgment by persons who demonstrate they are sensitive to the public sources of Medicaid program funds.

                        C.        The Fact That the States, Including Texas, Have Added Optional Service Categories to Their Medicaid Program, Demonstrates That Effective Cost Control Measures Are Already in Place.>       

            A significant measure of state Medicaid programs' ability to successfully implement the medical need-focused standard is that throughout the history of the Medicaid program states have expanded their optional services coverage.  Since 1984, for example, Texas has added covered categories of services in five different years, expanding its Medicaid program to cover the largest optional coverage population (the medically needy) and adding seven optional services, while deleting only two.[51]

CONCLUSION

            A recent review of the Medicaid program concluded:

 

Since its enactment in 1965, Medicaid has improved access to health care for the poor, pioneered innovations in health services delivery and community based long-term care services, and stood alone as the primary source of financial assistance for long-term care.  Medicaid has been consistently shown to improve access to health care for the population it serves. . .  As Medicaid struggles to meet multiple responsibilities under severe fiscal pressure, it continues to play a crucial role in providing acute and long-term care services to our nation's most vulnerable people.[52]

            As stated, Medicaid's role and its success have occurred because of the longstanding, widespread recognition that access to specific types of medical treatment must be measured by a medical need-focused standard, not an arbitrary statistical measure as Texas Medicaid proposed here.  The plain language of current Texas Medicaid regulations, the longstanding precedent of this Court, the administrative guidance and practices of other states and the overwhelming weight of authority from other courts all support this conclusion.  This appeal provides no basis in law or fact for this Court to reconsider this standard.  For all the reasons stated herein, Amicus Curiae Association of Tech Act Projects urges this Court to affirm the District Court decision requiring Texas Medicaid to provide an ACD to Fred C.

                                                            Respectfully Submitted,
                                                            MINNESOTA DISABILITY LAW CENTER

 

Dated:                          By:                                                       

4">                                                            Steven P. Elliot
                                                            Minnesota Attorney Registration Number 249312
                                                            Attorney for Amicus Curiae
                                                            430 First Avenue North, Suite 300
                                                            Minneapolis, Minnesota  55401-1780
                                                            (612) 332-1441

CERTIFICATE OF COMPLIANCE

 

            Pursuant to 5th Cir. R. 32.2.7(c), the undersigned certifies this Brief of Amicus Curiae, Association of Tech Act Projects complies with the type/volume limitations of 5th Cir. R. 29.3.  Exclusive of the exempted portions in 5th Cir. R. 32.2.7(b)(3), this brief contains 4,737 words and has been prepared in proportionally spaced typeface using WordPerfect 6.0 in Times Roman 14 pt. with footnotes in Times Roman 12 pt.  If the Court so requests, the undersigned will provide an electronic version of the brief and/or a copy of the word or line printout.  The undersigned understands a material misrepresentation in completing this certificate, or circumvention of the type/volume limits in 5th Cir. R. 32.2.7, may result in the court's striking the brief and imposing sanctions against the person signing the brief.

 

                                                                                                                                  

                                                                                    Steven P. Elliot



[1]See Fred C. v. Texas Health & Human Servs. Comm'n., 988 F. Supp. 1032, 1035 n.3 (W.D. Tex. 1997).

[2]All of the following requirements must be met for approval of medical equipment, appliances or supplies:

 

            *           the item has been recommended in writing by a licensed physician,

            *           the item is medically necessary because it is needed by a recipient who has a serious impairment to:  enhance well being, prevent further impairment, or increase self-care or reduce care provided by others [Self-care is defined as the ability of the recipient to take care of personal needs, e.g. eating, dressing, walking, talking, or using the device unassisted.  Less care or reduced care by others is defined as the ability of the recipient to use a minimum of assistance to take care of personal needs.]

            *           the item is not available through another agency,

            *           the item is covered by Medicaid,

            *           no equally effective and less costly course of treatment is available or suitable,

            *           the item is primarily medical in nature and is not a convenience item,

            *           special criteria have been met for certain items,

            *           the recipient's age and the circumstances surrounding the case indicate that the recipient can be trained to use a recommended appliance,

            *           for an appliance that requires skill and knowledge to use, a training plan has been established as part of the medical care plan, e.g., prosthetic training, and

            *           the appliance, equipment, or supply has been mandated as a medical necessity by a medical doctor, and consulting physicians for the Medicaid Program have agreed to the medical necessity of the item.  Note: The review by the consulting physicians will be done on a case-by-case basis. 

[3]The decision-making process governing requests for items of durable medical equipment, specifically ACDs, was addressed in the administrative proceedings that preceded the filing of Myers v. State of Mississippi, 3:94 CV 185 LN (S.D. Miss. June 23, 1995).  In that administrative proceeding Mississippi Medicaid stipulated on July 26, 1993 that:

         If an AAC device was determined by the Division of Medicaid to be medically necessary, the AAC device would be categorized and funded as durable medical equipment under the Mississippi Medicaid program. 

         The Mississippi Division of Medicaid's EPSDT Program has a non-exclusive DME list for children under the age of 21.  If the requested DME is included in the Division's DME Provider Manual, no Plan of Care is necessary for that equipment to be funded with Medicaid funds.  However, if the requested DME is not included in the Division's DME Provider Manual, the request must be submitted on a Plan of Care to the EPSDT Medical Review Team and, if found to be medically necessary, Medicaid funds would be available for the DME.

[4]Arizona Health Care Cost Containment System (AHCCCS) Medical Policy Manual, § 310 (Coverage criteria for Medical Supplies, Durable Medical Equipment and Orthotic/Prosthetic Devices (Oct. 1, 1994) (stating a definition of medical equipment and then stating covered items "include, but are not limited to" specified items).

[5]22 Cal. Code Regs. § 51521 (Jan. 9, 1968) (Equipment not on list of durable medical equipment will be covered, upon showing of individual medical need and related standards).

[6]Georgia Department of Medical Assistance, Policies and Procedures Manual, Part II, Durable Medical Equipment Services, § 806.11 (Apr. 1, 1997) (DME not on covered items list covered when medically necessary to meet catastrophic need).

[7]Maine Medical Assistance Manual, § 60.04-2 (Dec. 24, 1991) (including list of covered equipment and stating that "[a]ny [DME] not listed may be reimbursed by Medicaid with authorization prior to provision if the equipment is prescribed by a physician and it is the most cost effective equipment available that meets the medical needs of the recipient....").

[8]Minn. R. 9505.0310, subp. 4, A, defining scope of coverage for equipment and supplies, includes any item which meets the medical necessity and cost-effectiveness requirements of Minn. R. 9505.0210.

[9]See Nebraska Department of Social Services Manual, 471 NAC § 7-010.01, Manual Letter # 17-96 (March 18, 1996) (stating coverage for some items or equipment may be granted upon individualized review that establishes them as medically necessary, even if they do not meet the definition of DME).

[10]N.Y. Soc. Serv. Law, § 365-a(1) and (2); 18 NYCRR § 505.5(d)(1)(vi) (DME and prosthetic items not in fee schedule require prior authorization).

[11]Ohio Administrative Code, §§ 5101:3-1-01(C) & (D) (standard for access to specific types of treatment not ordinarily covered based on showing of medical necessity).

[12]Oregon Health Plan Admin. Regs., § 410-141-0480 (May 1, 1998) (treatments that are not currently identified with conditions in the Oregon Health Plan will be considered for coverage on an individual basis based on medical necessity and related factors).

[13]55 Pa. Code §§ 1150.63(b) and (d) (a medical service or item of a type covered by the program but not listed on an approved fee schedule may be approved on an individual basis when shown to be medically necessary).

[14]Tenn. Comp. R. & Reg. § 1200-13-1-.03(ee)(19) ("Other items of [DME] including prosthetic devices and orthotic appliances not listed above may be covered if prior approval is obtained, where a recipient's medical condition requires the use of the equipment, no other type of equipment will adequately meet the recipient's medical needs, there is no less expensive means of adequately meeting the recipient's medical needs, and the recipient's medical condition will seriously deteriorate without the equipment.")

[15]Beal v. Doe, 432 U.S. 438, 444-445 (1977).

[16]Curtis v. Taylor, 625 F.2d 645 (5th Cir. 1980).

[17]Rush v. Parham, 625 F.2d 1150 (5th Cir. 1980).

[18]Mitchell v. Johnston, 701 F.2d 337 (5th Cir. 1983).

[19]Hope Medical Group for Women v. Edwards, 63 F.3d 418 (5th Cir. 1995).

[20]See Preterm, Inc. v. Dukakis, 591 F.2d 121 (1st Cir.), cert. denied, 441 U.S. 952 (1979).

[21]See White v. Beal, 555 F.2d 1146 (3d Cir. 1977).

[22]See Pinneke v. Preisser, 623 F.2d 546 (8th Cir. 1980); Meyers v. Reagan, 776 F.2d 241 (8th Cir. 1985); Weaver v. Reagen, 886 F.2d 194 (8th Cir. 1989); cf. Ellis v. Patterson, 859 F.2d 52 (8th Cir. 1988); Meusberger v. Palmer, 900 F.2d 1280 (8th Cir. 1990).

[23]Cf. Dexter v. Kirschner, 984 F.2d 979 (9th Cir. 1992).

[24]See Hern v. Beye, 57 F.3d 906 (10th Cir. 1995), cert. denied, 516 U.S. 1011 (1995).

[25]Alexander L. v. Cuomo, 154 Misc.2d 945, 588 N.Y.S.2d 85, 88 (N.Y. Sup. Ct. N.Y. County 1991) (ordering NY Medicaid to cover Clozapine, a prescription drug for schizophrenia).

[26]E.g., Johnson v. Minn. Dept. of Human Serv., 565 N.W.2d 453, 456 (Minn. App. 1997) (requiring coverage of a stand-up wheelchair to meet recipient's specific medical needs); Davis v. Shrader, 687 N.E.2d 370 (Ind. App. 1997) (requiring coverage of orthopedic shoes; precluding use of irrebuttable presumptions against coverage of specific types of treatment within covered services); Myers v. State of Mississippi, No 3:94 CIV 185 LN (S.D. Miss. June 23, 1995) (rejecting Medicaid position that AAC devices are never medically necessary; determinations related to medical necessity must be based on contemporary professional knowledge and standards of practice) (copy in Addendum 2); Bowers v. Thompson; No. 89-2-00553-8 Stipulation & Agreement & Consent Order (Wash. Super. Ct. Thurston County Oct 15, 1990) (class action consent decree establishing medical need as decision-making standard for durable medical equipment, prosthetic devices and non-durable medical supplies) (copy in Addendum 2); Baker v. Commonwealth of Pa. Dept. of Pub. Welfare, 502 A.2d 318 (Pa. Commw. 1985) (approving wheelchair with 500-pound carrying capacity, based on individual proof of medical necessity; court holds DME is a required service).

[27]McCoy v. Dept. of Health & Welfare, 127 Idaho 972, 907 P.2d 110 (1995) (requiring coverage of gastric by-pass surgery to treat obesity; states are not permitted to categorically exclude specific types of treatment without ever considering whether they can be medically necessary); A.M.L. v. Dept. of Health, 863 P.2d 44, 47 (Utah App. 1993) (approval of breast reduction surgery within physicians' services and/or in- or out-patient hospital services; state concedes irrebuttable presumption against coverage of specific type of treatment is impermissible); Worthington v. Idaho Dept. of Health & Welfare, No. 69458 (Idaho D. Ct. 2d Jud. Dist. Nez Perce County Feb. 20, 1992) (requiring coverage of breast reconstruction following mastectomy) (copy in Addendum 2); Morgan v. Dept. of Health & Welfare, 120 Idaho 6, 813 P.2d 345 (Idaho 1991) (weight loss program as treatment for pseudotumor cerebri, a rare disorder, within the physicians' service benefit category); Doe v. Minn. Dept. of Pub. Welfare, 257 N.W.2d 816 (Minn. 1977) (requiring Medicaid to cover sex-re-assignment surgery, based on individual medical necessity for procedure).

[28]E.g., Marsh v. Commonwealth, Dept. of Pub. Welfare, 409 A.2d 926, 929 (Pa. Commw. 1979) (court directs Medicaid to cover specific type of laboratory test; rejects state's ability to exclude only the meaningful form of treatment or procedure within a covered benefit category).

[29]Rickaby v. Wis. Dept. of Health, 297 N.W.2d 36, 39 (Wisc. App. 1980) (requiring Medicaid to pay for replacement of power wheelchair for nursing facility resident; court rejects notion of state's entitlement to deference absent reasonable basis for its decision); Roberts v. Brian, 98 Cal. Rptr. 50, 489 P.2d 1378 (Calif. 1971) (requiring 1:1 attendant care be provided to nursing facility resident who suffered from rare, life-threatening seizure disorder).

[30]Bristol v. R.I. Dept. of Human Servs., C.A. No. 95-6605 (R.I. Super.Ct. Jan. 30, 1997) (requiring coverage of incontinence supplies for adults, based on their ability to meet criteria as medical supplies and their clear medical necessity) (copy in Addendum 2).

[31]Brisson v. Dept. of Soc. Welfare, 702 A.2d 405 (Vt. 1997) (approving closed circuit television system for adult with severe vision impairment, based on individual medical need); Ledet v. Fischer, 638 F. Supp. 1288 (M.D. La. 1986) (approval of eyeglasses for persons with refractive error; voiding exclusion of eyeglasses to all persons except those who had cataract surgery, even though only a very small number of persons will qualify for this type of treatment on the basis of comparable degree of medical need); accord, Simpson v. Wilson, 480 F. Supp. 97 (D. Vt. 1979) (same).

[32]Kirk v. Denning, 370 N.W.2d 113 (Neb. 1985) (rejecting exclusion of medically necessary periodontal treatment from scope of dental services).

[33]E.g., Visser v. Taylor, 756 F. Supp. 501, 507 (D. Kan. 1990) (approving coverage of Clozapine, a prescription drug, and concluding once medical necessity is established, the Medicaid Act and regulations are to be liberally construed in favor of the beneficiary); Jeneski v. Myers, 163 Cal. App. 3d 18, 209 Cal. Rptr. 178 (1985) cert. denied, 471 U.S. 1136 (1985) (rejecting coverage limitations on prescription drugs).

[34]McCoy v. Idaho Dept. of Health & Welfare, supra, 907 P.2d at 113 (citing Hern v. Beye, 57 F.3d 906, 911 n.3 (10th Cir. 1995)); accord Visser v. Taylor, supra, 756 F. Supp. at 507; Worthington v. Idaho Dept. of Health & Welfare, supra, slip op. at 5.

[35]Bristol v. R.I. Dept. of Human Servs., supra, slip op. at 11.

[36]988 F. Supp. at 1036.

[37]63 F.3d at 425.

[38]Pinneke v. Preiser, 623 F.2d 546, 549 (9th Cir. 1985); Weaver v. Reagan, 886 F.2d 194, 199-200 (8th Cir. 1989).

[39]See, e.g., Doe v. Minn. Dept. of Public Welf., supra, 257 N.W.2d at 819; Bristol v. R.I. Dept. of Human Servs., supra, slip op. at 8-12 (stating treating physicians opinions are entitled to deference and their prescriptions create a presumption to which Medicaid must respond with an medically-based explanation); Johnson v. Minn. Dept. of Human Serv., supra, 565 N.W.2d at 457-459; see also Worthington v. Idaho Dept. of Health & Welfare, supra, slip op. at 5.

[40]Ohio Administrative Code, § 5101:3-1-01(A)(1). 

[41]Minn. R. 9505.0175, Subp. 25, A.

[42]18 NYCRR § 500.1(b).

[43]Nebraska Department of Social Services Manual, 471 NAC § 1-002, Manual Letter # 44-95 (July 25, 1995).

[44]See, e.g., Minn. Stat. § 256B.04, Subd. 15(1);  55 Pa. Code § 1150.63 (c);  Louisiana Medicaid Eligibility Manual, supra, at page 2.

[45]See, e.g., 22 Cal. Code Regs. § 51321(b) and (f) ("lowest cost item that meets the patient's medical needs");  Minn. R. 9505.5030, E ("least expensive appropriate alternative health service available"); Ohio Administrative Code, § 5101:3-1-01(D)(6) ("lowest cost alternative that effectively addresses and treats the medical problem");  Tenn. Comp. R. & Reg. § 1200-13-1-03(ee)(19) ("no less expensive means of adequately meeting the recipient's medical needs"). 

[46]For an example of such a case see Johnson v. Minn. Dept. of Human Serv., supra, 565 N.W.2d at 459.

[47]See, e.g., Minn. R. 9505.0175, Subp. 10;  18 NYCRR § 505.5(a)(1).

[48]See, e.g., Nebraska Department of Social Services Manual, 471 NAC § 7-004, Manual Letter # 17-96 (March 18, 1996);  18 NYCRR § 505.5(a)(1)(ii).

[49]See Minnesota Health Care Programs Provider Manual, Chapter 17, page 8, March 1998.  Among these criteria are:

 

                     An assessment of the recipient's/enrollee's verbal and physical capabilities in relation to need and use of an augmentative communication device (electronic and non-electronic).

 

            -            An explicit evaluation of each augmentative communication device or method of communication tried by the recipient/enrollee and information on the effectiveness of each device.  All parameters of device selection must be addressed (e.g., interactive ability in all situational contexts; school, home, vocational, work, and social environments).  A trial period of the device requested is not mandatory if objective data provides documentation for purchase.

[50]States have also controlled Medicaid costs by:

 

                     excluding experimental treatment;

 

                     limiting the professionals able to participate as Medicaid providers for specific types of treatment;

 

                      setting useful life standards applicable to device replacements; and

 

                        setting severity of need-based eligibility standards for covered services, such as through imposition of a homebound requirement for access to home health care services and thereby, to the DME benefit.

[51]During this period, Texas Medicaid expanded its program 5 times: in 1984-85 to cover all persons who are medically needy; in 1987-1988, it added hospice services for all beneficiaries; in 1988-1989, it added case management services and clinic services for all beneficiaries; in 1989-1990, it added physical therapy and respiratory care for all beneficiaries, while deleting diagnostic services; and in 1994-1995, it added medical social worker services for all beneficiaries and deleted tuberculosis related services.  Both Louisiana and Mississippi Medicaid experienced even greater program expansion than Texas during this period.  From 1984-1996, Louisiana Medicaid added 13 services, while deleting 4, and deleted and then restored 2 others; Mississippi Medicaid added 18 services, deleted only 2, and deleted and restored 2 others.  U.S. Department of Health & Human Services, Health Care Finance Administration, Office of Intergovernmental Affairs, "Medicaid Services State by State" HCFA Publ. No. 02155-97 (Oct. 1, 1997); HCFA Publ. No. 02155-96 (Oct. 1, 1996); HCFA Publ. No. 02155-95 (Oct. 1, 1994); HCFA Publ. No. 02155-94 (Oct. 1, 1993); HCFA Publ. No. 02155-93 (Oct. 1, 1992); HCFA Publ. No. 02155-92 (Oct. 1, 1991); HCFA Publ. No. 02155-91 (Oct. 1, 1990); HCFA Publ. No. 02155-90 (Oct. 1, 1989); HCFA Publ. No. 02155-89 (Oct. 1, 1988); HCFA Publ. No. 02155-88 (Oct. 1, 1987); HCFA Publ. No. 02155-87 (Oct. 1, 1986); HCFA Publ. No. 02155-86 (Oct. 1, 1985); HCFA Publ. No. 02155-85 (Oct. 1, 1984).

[52]Kaiser Commission on the Future of Medicaid, Health Needs and Medicaid Financing: State Facts 6 (1995).

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