Texas Health and Human Services Commission v. Linda Puglisi

Opinion

ACCEPTED 03-15-00226-CV 6056931 THIRD COURT OF APPEALS AUSTIN, TEXAS 7/14/2015 12:54:37 PM JEFFREY D. KYLE CLERK No. 03-15-00226-CV _________________________________ FILED IN IN THE 3rd COURT OF APPEALS AUSTIN, TEXAS THIRD COURT OF APPEALS 7/14/2015 12:54:37 PM AUSTIN, TEXAS JEFFREY D. KYLE _________________________________ Clerk

TEXAS HEALTH AND HUMAN SERVICES COMMISSION, Appellant,

v.

LINDA PUGLISI, Appellee. _________________________________

On Appeal From The 53rd Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-000381 The Honorable Judge Gisela D. Trianna _________________________________

BRIEF OF APPELLEE _________________________________

MAUREEN O’CONNELL Texas Bar No. 00795949 SOUTHERN DISABILITY LAW CENTER 1307 Payne Avenue Austin, Texas 78757 T: 512.458.5800 F: 512.458.5850 moconnell458@gmail.com Attorney for Appellee

ORAL ARGUMENT REQUESTED TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................i

TABLE OF AUTHORITIES ................................................................................... iii

ISSUES PRESENTED............................................................................................... x

LEGAL FRAMEWORK OF THE MEDICAID PROGRAM .................................. 2

STATEMENT OF FACTS ........................................................................................ 4

SUMMARY OF THE ARGUMENT ........................................................................ 9

ARGUMENT ........................................................................................................... 11

A. The Trial Court Correctly Denied HHSC’s Motion to Dismiss ................. 11

B. The Trial Court Correctly Reversed and Remanded the Case to HHSC for Further Proceedings Consistent with Its Decision ................ 16

C. Deference is Not Owed to HHSC’s Post-Hoc Interpretation of Agency Rules .............................................................................................. 18

D. The Trial Court Correctly Determined that HHSC’s Hearing Decision Fails to Comply with Medicaid Law ........................................... 20

E. The Trial Court Correctly Determined that HHSC’s Hearing Decision is Arbitrary, Capricious, Unreasonable and Unsupported by Substantial Evidence ........................................................ 22

1. The trial court properly addressed the two reasons Molina denied Linda Puglisi’s prior authorization request ................. 22

2. HHSC failed to address Linda Puglisi’s medical need for a custom power wheelchair with integrated standing feature .................................................................................................. 24

3. HHSC failed to employ the correct test for determining Medicaid coverage of DME ................................................................ 34 i F. HHSC Violated Linda Puglisi’s Procedural Due Process Rights .......................................................................................................... 45

1. Medicaid beneficiaries have a protected property interest in their Medicaid benefits .................................................................... 45

2. Molina’s denial notice does not comport with due process and HHSC failed to address this issue ................................... 47

3. HHSC’s administrative review does not comport with State law and further compounded the due process violations in this case .......................................................................... 49

PRAYER .................................................................................................................. 49

CERTIFICATE OF COMPLIANCE ....................................................................... 50

CERTIFICATE OF SERVICE ................................................................................ 51

ii TABLE OF AUTHORITIES

CASES

Ability Center of Toledo v. Lumpkin, 808 F.Supp.2d.1003 (N.D. Ohio 2011) .............................................................. 46

Allegent Health v. Amer. Farm Ins., Inc., 656 N.W.2d 906 (Neb. 2003) ............................................................................. 12

Alvarez v. Betlach, 572 F. App’x 519 (9th Cir.) ................................................................................ 36

Baker v. Commonwealth of Pa. Dept. of Pub. Welfare, 502 A.2d 318 (Pa. Commw. 1985) ...............................................................36, 37

Bell v. Agency for Health Care Admin., 768 So.2d 1203 (FL. App. 2000) ..................................................................36, 37

Blue v. Bonta, 99 Cal.App. 4th 980, 121 Cal.Rptr.2d 483 (Cal App. 2002) .............................. 36

Bowers v. Thompson; No. 89-2-00553-8 (Wash. Super. Ct. Thurston County Oct. 15, 1990) .......36, 37

Brisson v. Dep’t of Social Welf., 702 A.2d 405 (VT. 1997)..............................................................................36, 37

Bristol v. R.I. Dept. of Hum. Serv., 1997 WL 839884 (R.I. Super. Jan. 30, 1997) ..................................................... 36

Combs v. Entertainment Publications, Inc., 292 S.W. 3d 712 (Tex. App.—Austin 2009, no pet.) ......................................... 42

Davis v. Shah, 2012 WL 1574944 (W.D.N.Y. May 3, 2012)..................................................... 36

Davis v. Shrader, 687 N.E.2d 370 (Ind. App. 1997) .................................................................36, 37

iii DeSario v. Thomas, 139 F.3d 80 (2d Cir. 1998) ................................................................................. 37

Detgen v. Janek, 945 F. Supp. 2d 746 (N.D. Tex. 2013) ............................................................... 23

Detgen v. Janek, 752 F. 3d 627 (5th Circuit 2014) ............................................................35, 36, 37

El Paso Hosp. Dist. v. Texas Health and Human Servs. Comm’n, 247 S.W. 3d 709 (Tex. 2008) ............................................................................. 43

Evanston Hosp. v. Hauck, 1992 WL 205900 (N.D. Ill. 1992) ...................................................................... 12

Fishman v. Daines, 743 F.Supp.2d. 127 (E.D. N.Y 2010) ................................................................. 46

Frank v. Thomas, No. 3:98CV00306(GLG), U.S. Dist. Ct., D. Conn. 1998................................... 15

Fred C. v. Texas Health & Human Services Comm’n, 988 F.Supp. 1032 (W.D.Tx. 1997) ..................................................................... 36

Goldberg v. Kelly, 397 U.S. 254 (1970) ............................................................................................ 45

Gray Panthers v. Schweiker, 652 F. 2d 146 (D.C. Cir. 1980) ........................................................................... 47

Hamby v. Neel, 368 F.3d. 549 (6th Cir. 2004) .......................................................................45, 46

Hiltibran v. Levy, 793 F.Supp.2d 1108 (W.D. Mo. 2011) ............................................................... 36

Hunter v. Chiles, 944 F.Supp. 914 (S.D. Fl. 1996) ...................................................................36, 37

iv Jasset v. R.I. Dept. of Hum. Serv., 2006 WL 2169891 (R.I. Super. July 31, 2006) .................................................. 36

Johnson v. Guhl, 91 F.Supp. 2d 754 (D. N.J. 2000) ....................................................................... 46

Johnson v. Minn. Dept. of Human Serv., 565 N.W.2d 453 (Minn. App. 1997) ............................................................36, 37

Jonathan C. v. Hawkins, 2006 WL 3498494 (E.D. Tex. Dec. 5, 2006) ..................................................... 45

Koenning v. Janek, 539 Fed. Appx. 353 (5th Cir. 2013).................................................................... 39

Koenning v. Suehs, 897 F. Supp.2d 528 (S.D. 2012) ......................................................................... 39

Ladd v. Thomas, 962 F. Supp 284 (D. Conn. 1997) .................................................................45, 46

Lankford v. Sherman, 451 F.3d 496 (8th Cir. 2006) ..................................................................34, 36, 37

Ledet v. Fischer, 638 F. Supp. 1288 (M.D. La. 1986)..............................................................36, 37

Liberty Mut. Ins. Co. v. Texas Dep't of Ins., 187 S.W. 3d 808 (Tex. App. Austin 2006, pet denied) ...................................... 46

Mayhew v. Town of Sunnyvale, 964 S.W.2d 922 (Tex.1998)................................................................................ 11

Meyers v. Reagen, 776 F.2d 241 (8th Cir. 1985) .............................................................................. 36

Myers v. State of Mississippi, 3:95 CV 185 LN (Slip Op. S.D. Miss. 1995) ...............................................36, 37

v Neuwrith v. Louisiana State Bd. of Dentistry, 845 F. 2d 553 (5th Cir. 1988) ............................................................................. 46

Ohlson v. Weil, 953 P.2d 939 (Colo. App. 1997) ...................................................................36, 37

Patterson v. Planned Parenthood of Houston & Se. Texas, Inc., 971 S.W.2d 439 (Tex. 1998) .............................................................................. 11

Perry v. Del Rio, 66 S.W.3d 239 (Tex. 2001)................................................................................. 16

Public Utility Commission v. South Plains Electric Cooperative, Inc., 635 S.W.2d 954 (Tex.App.—Austin 1982, writ ref'd n.r.e.) .............................. 44

Rastetter v. Weinberger, 379 F.Supp. 170 (D.AZ. 1974) ........................................................................... 12

Rodriguez v. Serv. Lloyds Ins. Co., 997 S.W.2d 248 (Tex. 1999) ........................................................................21, 43

Roe v. Norton, 522 F.2d 928 (2d Cir. 1975) ............................................................................... 12

Skubel v. Fuoroli, 113 F.3d 330 (2d Cir. 1997) ............................................................................... 12

Slekis v. Thomas, 525 U.S. 1098 (1999) .......................................................................................... 38

Stanford v. Butler, 181 S.W.2d 269 (Tex.1944)................................................................................ 19

Sw. Pharmacy Solutions, Inc. v. Texas Health & Human Servs. Comm’n, 408 S.W.3d 549 (Tex. App. 2013)...................................................................... 18

Tarrant Appraisal Dist. v. Moore, 845 S.W.2d 820 (Tex. 1993) .............................................................................. 19

vi Texas Alcoholic Beverage Comm’n v. Amusement & Music Operators of Tex., Inc., 997 S.W.2d 651 (Tex. App.—Austin 1999, pet. dism’d w.o.j.) ......................... 41

Texas State Bd. of Pharmacy v. Witcher, 447 S.W.3d 520 (Tex. App. 2014)...................................................................... 43

Thompson v. Roob, 2006 WL 2990426 (S.D. Ind. Oct. 19, 2006) ...............................................45, 48

T.L. v. Colorado Dept. of Health Care Policy & Fin., 42 P.2d 63 (Colo. App. 2002) ............................................................................. 36

Waco Indep. Sch. Dist. v. Gibson, 22 S.W.3d 849 (Tex. 2000)................................................................................. 11

Weaver v. Reagan, 886 F. 2d 194 (8th Cir. 1989) ............................................................................. 25

Wilder v. Virginia Hospital Association, 496 U.S. 498 (1990) .............................................................................................. 2

Will T. v. Taylor, 465 F.Supp.2d 1267 (N.D. Ga. 2000) ................................................................. 36

Woody v. Dallas, 809 F. Supp. 466 (N.D. Tex. 1992) .................................................................... 46

REGULATIONS

1 TEX. ADMIN. CODE § 354.1031 .......................................................................20, 39

1 TEX. ADMIN. CODE § 354.1031(b)(12).............................................................. 3, 20

1 TEX. ADMIN. CODE § 354.1035 .................................................................20, 21, 39

1 TEX. ADMIN. CODE § 354.1039 .................................................................20, 21, 29

1 TEX. ADMIN. CODE § 354.1039(a) ..................................................................18, 19 vii 1 TEX. ADMIN. CODE § 354.1039(a)(4)(A) ........................................................18, 19

1 TEX. ADMIN. CODE § 354.1039(a)(4)(D) ..............................................4, 20, 24, 38

1 TEX. ADMIN. CODE § 354.1040 .............................................. 13, 20, 21, 39, 40, 42

1 TEX. ADMIN. CODE § 354.1040(d)(3).................................................................... 13

1 TEX. ADMIN. CODE § 354.1040(g) ........................................................................ 13

1 TEX. ADMIN. CODE § 354.1041 ............................................................................. 12

1 TEX. ADMIN. CODE § 354.1041(2)(B) ................................................................... 13

1 TEX. ADMIN. CODE § 354.2321(b) ........................................................................ 14

1 TEX. ADMIN. CODE § 354.2321(f) ......................................................................... 14

1 TEX. ADMIN. CODE § 355.8021(b)(2-3) ................................................................ 13

1 TEX. ADMIN. CODE § 357.3(b)(1)(E) ..............................................................46, 47

1 TEX. ADMIN. CODE § 357.9 ................................................................................... 27

1 TEX. ADMIN. CODE § 357.703 ................................................................................. 8

1 TEX. ADMIN. CODE § 357.703(b)(3)...................................................................... 42

42 C.F.R. § 431.10(e)(1) ............................................................................................ 2

42 C.F.R. § 200 ........................................................................................................ 47

42 C.F.R. § 431.210(b) ......................................................................................31, 47

42 C.F.R. § 431.210(c).................................................................................18, 31, 47

42 C.F.R. § 435.930 ................................................................................................... 4

42 C.F.R. § 438.210(a)(4)(i) .................................................................................... 28 viii 42 C.F.R. § 438.404 ................................................................................................. 47

42 C.F.R. § 440.70(b)(3) ............................................................................................ 3

42 C.F.R. § 440.230(b) ..................................................................................3, 38, 44

42 C.F.R. § 440.230(c)...................................................................................3, 38, 44

42 C.F.R. § 440.240(a)............................................................................................. 34

STATUTES

42 U.S.C. § 1396 ........................................................................................................ 2

42 U.S.C. § 1396a(a)(3) ........................................................................................... 47

42 U.S.C. § 1396a(a)(5) ............................................................................................. 2

42 U.S.C. § 1396a(a)(8) ............................................................................................. 4

42 U.S.C. § 1396a(a)(10(B) ..................................................................................... 34

42 U.S.C. § 1396a(a)(17) ...............................................................................3, 38, 44

42 U.S.C. § 1396d(a)(7) ............................................................................................. 3

42 U.S.C. § 1396w2 ................................................................................................... 2

42 U.S.C. § 1396-1..................................................................................................... 2

TEX. GOV’T CODE § 531.019(c) ............................................................................. 1, 8

TEX. GOV’T CODE § 531.021(a) ................................................................................. 2

TEX. GOV’T CODE § 2001.003(6) ............................................................................. 41

TEX. GOV’T CODE § 2001.023.................................................................................. 43

ix TEX. GOV’T CODE § 2001.030.................................................................................. 43

TEX. GOV’T CODE § 2001.038............................................................................39, 40

TEX. GOV’T CODE § 2001.171.................................................................................... 1

TEX. HUM. RES. CODE § 32.0425 .................................................................19, 40, 42

OTHER AUTHORITIES

In the Matter of Mary A., New York Dept. of Social Services................................ 14

RESNA Position on the Application of Wheelchair Standing Devices, Assistive Technology, 21:161-168, 2009 ................................................................... 6

x ISSUES PRESENTED

1. Did the trial court correctly deny HHSC’s motion to dismiss?

2. Did the trial court correctly reverse and remand the case to HHSC for further proceedings consistent with the court's decision?

3. Did the trial court correctly determine that HHSC’s post hoc interpretation of agency rules is not entitled to deference?

4. Did the trial court correctly determine that HHSC’s hearing decision fails to comply with Medicaid law?

5. Did the trial court correctly determine that HHSC’s hearing decision is arbitrary, capricious, unreasonable and unsupported by substantial evidence?

6. Did HHSC violate Linda Puglisi’s procedural due process rights as a Medicaid beneficiary?

xi No. 03-15-00226-CV _________________________________

IN THE THIRD COURT OF APPEALS AUSTIN, TEXAS _________________________________

TEXAS HEALTH AND HUMAN SERVICES COMMISSION, Appellant,

v.

LINDA PUGLISI, Appellee. _________________________________

On Appeal From The 53rd Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-000381 The Honorable Judge Gisela D. Trianna _________________________________

BRIEF OF APPELLEE _________________________________

To the Honorable Third Court of Appeals:

This appeal arises out of a Medicaid hearing decision issued by the Texas

Health and Human Services Commission (HHSC) denying Linda Puglisi’s request

for Medicaid prior authorization of a custom power wheelchair with integrated

standing feature. Linda filed a Petition for Judicial Review in the Travis County

District Court to challenge this denial. TEX. GOV’T CODE §§ 531.019(c) and

2001.171 et seq. The trial court reversed the agency’s decision, finding it arbitrary, capricious, unreasonable, and unsupported by substantial evidence. The trial

court's decision should be affirmed.

LEGAL FRAMEWORK OF THE MEDICAID PROGRAM

In 1965, Congress enacted Title XIX of the Social Security Act to establish

Medicaid, a federal-state program designed to provide medically necessary health

care to low income families and individuals with disabilities. 42 U.S.C. §§ 1396-

1396w2. The purpose of this program is to enable states “to furnish…rehabilitation

and other services to help such families and individuals attain or retain the

capability for independence or self-care.” 42 U.S.C. § 1396-1. State participation

in Medicaid is optional, however, “once a state chooses to join, it must follow the

requirements set forth in the Medicaid Act and its implementing regulations.”

Wilder v. Virginia Hospital Association, 496 U.S. 498, 502 (1990).

The Centers for Medicare and Medicaid Services (CMS) provide federal

oversight of state Medicaid programs, however, each state must designate a single

state agency to administer its Medicaid program. 42 U.S.C. § 1396a(a)(5). HHSC

is the designated Medicaid agency in Texas. TEX. GOV’T CODE § 531.021(a). As

the single state agency, HHSC must comply with all federal Medicaid

requirements when promulgating rules and establishing policy and cannot delegate

its authority on program matters to its contracted entities. 42 C.F.R. § 431.10(e)(1).

HHSC’s contracted entities, which include managed care organizations and the

2 Texas Medicaid and Healthcare Partnership (TMHP), must comply with all

Medicaid legal requirements when deciding whether requested medical services

will be approved for eligible beneficiaries.

At issue in this case is medical equipment, a required component of the

Medicaid home health category of service. 42 U.S.C. § 1396d(a)(7); 42 C.F.R. §

440.70(b)(3). Federal law does not presently define the term durable medical

equipment (DME), however, the Health Care Financing Administration (now

CMS) issued official guidance in 1998 concerning this mandatory Medicaid

benefit. HHSC App. 6. Known as the DeSario Letter, this guidance clarified that

state Medicaid programs must comply with the Medicaid Act’s reasonable

standards requirement, 42 U.S.C. § 1396a(a)(17), and amount duration, and scope

rule, 42 C.F.R. § 440.230(b-c), in administering the DME benefit. In 2013, CMS

reaffirmed the continuing application of this federal policy when it wrote to

HHSC’s Medicaid Director to explain that Texas Medicaid must provide DME

when the requested item: (1) is a covered benefit; and (2) is medically necessary

for the individual requesting it. Puglisi App. 1.

An item of medical equipment is covered by Medicaid if it meet HHSC’s

definition of DME. Puglisi App. 1. By rule, 1 TEX. ADMIN. CODE §

354.1031(b)(12), DME is defined as:

3 [m]achinery or equipment which meets one or both of the following criteria: (A) the projected term of use is more than one year; or (B) reimbursement is made at a cost of more than $ 1,000.

Texas Medicaid policy, TMPPM DME Handbook 2.2.2, further defines DME as:

Medical equipment or appliances that are manufactured to withstand repeated use, ordered by a physician for use in the home, and required to correct or ameliorate a client’s disability, condition or illness.

HHSC App. 4, 5.

An item of DME is medically necessary when “required to correct or

ameliorate the individual’s disability, medical condition, or illness” or in

exceptional circumstances, found to “serve a specific medical purpose.” TMPPM

DME Handbook 2.2.2; 1 TEX. ADMIN. CODE § 354.1039(a)(4)(D). HHSC App. 4,

5. Once these criteria - coverage and medical necessity - are met by an eligible

beneficiary, HHSC or its contracted entity must prior authorize the requested item

of DME with reasonable promptness. 42 U.S.C. § 1396a(a)(8); 42 C.F.R. §

435.930.

STATEMENT OF FACTS

The facts underlying Linda Puglisi’s request for Medicaid prior

authorization of a custom power wheelchair with integrated standing feature were

largely uncontested at HHSC’s hearing. In 2011, Linda sustained a C1-4 spinal

cord injury during surgery to remove a tumor from her neck. Puglisi App. 2, p.50.

This injury left her paralyzed, dependent upon a ventilator to breathe and a feeding

4 tube for sustenance. Following months of hospitalization and inpatient

rehabilitation, the ventilator and feeding tube were discontinued. Linda remained

paralyzed however, and is no longer able to walk. She requires a custom power

wheelchair for all mobility. Puglisi App. 2, p. 50; App. 3, pp. 63-64; AR 310.

In February 2013, Linda was admitted to TIRR Memorial Hermann Hospital

for physical rehabilitation. While there, she underwent a comprehensive

wheelchair assessment, which provides extensive information concerning her

disability and the numerous medical conditions she faces as a result. Puglisi App.

3, pp. 63-71: HHSC App. 2, Finding of Fact 3; App. 3, Finding of Fact 4. This

evaluation explains that Linda has “impaired integumentary sensation, respiratory

function, neurogenic bowel, and neurological pain.” She also faces an “increased

risk for bone density loss and compromised soft tissue integrity secondary [due] to

not being able to bear weight through [her bilateral lower extremities].” Puglisi

App. 3, p. 64.

The evaluation team recommended a custom power wheelchair with

integrated standing feature to address Linda’s many medical conditions and to

allow her to “independently perform pressure relief and weight bearing through her

[lower extremities] preventing skin breakdown and bone density loss, as well as

enhancing biomechanical alignment throughout the entire body on a daily basis,

5 which helps to prevent further impact of spasticity on joints in upright postures.” 1

Puglisi App. 3, p. 68-69. Linda’s attending physical medicine and rehabilitation

specialist attested to her medical need for the recommended wheelchair with

standing feature.2

As required, a Medicaid-enrolled DME supplier requested prior

authorization of the recommended wheelchair from Molina Healthcare of Texas

(Molina), a managed care organization under contract with HHSC. HHSC App. 2,

Findings of Fact 1, 4; App.3, Findings of Fact 1,5. Molina referred the request to a

third-party entity “for review of medical necessity…” HHSC App. 2, Finding of

Fact 5. This reviewer informed the DME supplier that it would have to substitute a

different wheelchair base and remove the seat elevator and standing feature before

Molina would approve a power wheelchair for Linda. AR 132-133. In response,

the DME supplier submitted extensive documentation, including several

professional publications explaining the medical benefits of standing for people

with spinal cord injuries and their use of wheelchairs with integrated standing

1 Custom wheelchairs with integrated standing systems are well-recognized in the rehabilitation profession as a means of addressing the “painful, problematic, and costly secondary complications” that result from prolonged sitting. These wheelchairs “allow for more frequent, random, and independent performance of standing” than separate standing devices. See RESNA Position on the Application of Wheelchair Standing Devices, Assistive Technology, 21:161-168, 2009. Puglisi App. 4. 2 The recommended wheelchair has an integrated multi-positional standing system. This wheelchair requires a Group 4 base to accommodate the standing feature and several additional power seat functions, including tilt and recline, center mount articulating elevating leg rests, stand and drive leg rest assembly, and seat elevation, all of which are required to operate the standing function. Puglisi App. 5, ¶5. 6 features. AR 47-117. This documentation also included additional medical

justification by Linda’s attending physician who further explained Linda’s

diagnoses and functional status, the secondary medical conditions she faces as a

result of prolonged sitting (12 hours) in her wheelchair each day, her need to stand

numerous times throughout the day without risk of transfer injuries, her inability to

independently use a separate stander, and the underlying rationale for

recommending a custom power wheelchair with integrated standing feature as the

only item of equipment that will address Linda’s complex medical needs.3 Puglisi

App. 2, p. 50-52. The DME supplier also explained why certain components could

not be “removed” from the recommended wheelchair as requested by Molina’s

outside reviewer. AR 49.

On May 30, 2013, the reviewer provided his “itemized collection of thoughts

on the equipment in question.” He did not dispute Linda’s medical conditions or

refute the professional opinions of her medical providers. He acknowledged that

Linda’s medical providers “offered very detailed benefits of standing” and “they

note that the member is unable to reap these benefits unless they have the stander

on their chair… .” AR 118-119.

3 There are two general types of standing devices. One is a non-mobile separate stander that requires the user to transfer in and out of the device whenever he or she needs to stand. The other is a standing feature integrated into a custom wheelchair, which allows for independent standing without assistance from care providers and the risk of transfer injuries. 7 On June 6, 2013, Molina denied Linda’s wheelchair request, stating among

other things, that the standing feature was neither covered by Medicaid nor

medically necessary and the seat elevator was not medically necessary. Molina did

not contest Linda’s medical need to stand throughout the day as recommended by

the evaluation team. HHSC App. 1.

A Medicaid fair hearing was requested on June 24, 2013, and was held on

October 30, 2013. AR 267; 19. For the purpose of this hearing, TIRR’s attending

physician provided an additional letter of medical necessity explaining Linda’s

medical need for the recommended wheelchair and further advising that “the team

responsible for conducting Linda’s wheelchair evaluation in February 2013

continues to support their recommendation for a custom power wheelchair with

integrated standing feature for Linda.” Linda’s physician also reaffirmed that a

separate stander would not be effective in addressing the numerous secondary

medical conditions she faces due to her spinal cord injury. Puglisi App. 6.

In November 2013, HHSC’s hearing officer sustained Molina’s prior

authorization denial. HHSC App. 2. Linda requested an administrative review of

this decision pursuant to TEX. GOV’T CODE § 531.019(c) and 1 TEX. ADMIN. CODE

§ 357.703. AR Tab 16, 1-14. On January 14, 2014, an HHSC attorney sustained

the hearing officer’s decision and upheld Molina’s denial of the recommended

wheelchair. HHSC App. 3. Having exhausted her administrative remedies, Linda

8 filed a Petition for Judicial Review on February 7, 2014. CR3-31. While this case

was pending in the trial court, HHSC informed Linda that, effective May 2014, she

would be dually eligible for both Medicaid and Medicare. This dual eligibility

status is known as a Medicaid Qualified Medicare Beneficiary (MQMB). Five

months later, HHSC filed a motion to dismiss, claiming the case was not ripe

because of Linda’s dual eligibility. CR 199. The trial court denied this motion in

November 2014. CR 314. On January 15, 2015, the court reversed HHSC’s

hearing decision, finding that Linda was entitled to Medicaid prior authorization of

the recommended wheelchair. CR 348-349.

SUMMARY OF THE ARGUMENT

The trial court correctly determined it had subject matter jurisdiction of this

case and properly denied HHSC's motion to dismiss. The facts underlying this

case were ripe when it was filed and continue to be ripe today. No intervening

event, including Linda’s dual eligibility for Medicaid and Medicare, has rendered

this case unripe for adjudication.

The trial court properly tailored its decision on the merits to HHSC’s denial

of Medicaid prior authorization for the recommended wheelchair and remanded the

case for further action consistent with its decision. The court was not required to

remand the case to allow HHSC to “change its findings and decision.” Nor was

the court obligated to defer to HHSC’s post hoc interpretation of agency rules or to

9 consider “regulatory prerequisites” that were not identified during the

administrative proceeding as the basis for Molina’s denial of Linda’s prior

authorization request.

Molina identified two reasons for its prior authorization denial - - Medicaid

coverage of the recommended standing feature and Linda’s medical necessity for

the standing feature and seat elevator. The first is a legal question the trial court

resolved by finding that “HHSC’s administrative decision fails to comply with the

controlling federal and state law, and thus, is arbitrary, capricious, and

unreasonable.” The second is a question of fact the trial court resolved based upon

the evidence submitted by Linda’s treating medical providers and Molina’s failure

to refute this evidence. On this issue, the trial court correctly determined that

HHSC’s decision was not supported by substantial evidence.

At the fair hearing, Molina had the burden to prove that the reasons for

denial cited in its notice of adverse action were factually accurate and legally

correct, but failed to meet this burden. Like Molina, HHSC failed to employ the

correct test for determining Medicaid coverage of DME and to apply the agency’s

own medical necessity standards established in rule and policy. Finally, Linda’s

due process rights as a Medical beneficiary were violated in this case, first by

Molina’s failure to provide legally sufficient notice, and then by HHSC’s attorney

10 who based his decision on grounds that were not identified in Molina’s denial

notice. The trial court’s decision is correct and should be affirmed.

ARGUMENT

A. The Trial Court Correctly Denied HHSC’s Motion to Dismiss.

HHSC’s claim that the trial court lacked subject matter jurisdiction has no

merit. The court correctly rejected HHSC’s assertion that Linda’s dual eligibility

for Medicaid and Medicare rendered her case unripe and properly denied the

agency’s motion to dismiss. While ripeness is a “threshold issue that implicates

subject matter jurisdiction,” Patterson v. Planned Parenthood of Houston & Se.

Texas, Inc., 971 S.W.2d 439, 442 (Tex. 1998) citing Mayhew v. Town of

Sunnyvale, 964 S.W.2d 922, 928 (Tex.1998), there is no question this case was ripe

when filed and continues to be ripe today. This case does not involve “uncertain or

contingent future events that may not occur as anticipated or may not occur at all.”

Waco Indep. Sch. Dist. v. Gibson, 22 S.W.3d 849, 851-52 (Tex. 2000). Rather, the

facts of this case “have developed sufficiently so that an injury has occurred…”

439 S.W.2d at 442. (citations omitted). This injury – denial of Medicaid prior

authorization of a power wheelchair with integrated standing feature – occurred

prior to the filing of this action and continues to date.

Contrary to HHSC’s claim, Linda’s dual eligibility is not a “significant

intervening event” that renders her case for Medicaid prior authorization unripe.

11 HHSC Brief, p.10. It does not matter that “Texas law requires HHSC to analyze

claims submitted under Medicaid to ensure claims are submitted first under

Medicare to the extent allowed by law.” (emphasis added) HHSC Brief, p.9. This

case is not about the payment of claims: it is about the unlawful denial of prior

authorization of a Medicaid service. Medicare’s primary payor status does not

dictate any particular order for securing prior authorization of the recommended

wheelchair.4

HHSC’s assertion that Linda “is required to avail herself of the CMS prior

authorization process and procedure in the first instance” is wrong. HHSC Brief,

p. 11. HHSC does not identify any authority to support this claim and for good

reason – no such requirement exists in either Medicare or Medicaid law or policy.5

These are separate programs, enacted with distinct purposes and established with

different coverage and medical necessity standards.6

4 For dually eligible individuals, Medicare is the primary payor, while Medicaid is secondary. 1 TEX. ADMIN. CODE § 354.1041. 5 The DME MAC Supplier Manual cited by HHSC offers no support for the agency's assertion that Medicare prior authorization must be obtained “in the first instance.” HHSC App. 11. 6 Numerous courts have recognized the differences between Medicaid and Medicare. See e.g., Skubel v. Fuoroli, 113 F.3d 330, 336 (2d Cir. 1997), aff’g 925 F.Supp. 930, 941(D.Conn. 1996)(rejecting reliance on Medicare regarding scope of Medicaid coverage of home health care services); Roe v. Norton, 522 F.2d 928, 933-34n.5 (2d Cir. 1975)(does not infer medical need is analogous between Medicare and Medicaid); Rastetter v. Weinberger, 379 F.Supp. 170, 172 (D.AZ. 1974)(Medicaid is a different law with a different purpose than Medicare); Allegent Health v. Amer. Farm Ins., Inc., 656 N.W.2d 906, 911 (Neb. 2003)(Medicare is a program with a different purpose and different standards than Medicaid)(citing Evanston Hosp. v. Hauck, 1992 WL 205900 (N.D. Ill. 1992)(Medicare and Medicaid are entirely separate programs with different purposes and standards; federal Medicare enactments do not provide any mandates for state Medicaid practices.) aff’d 1 F.3d 540 (7th Cir. 1993), cert. den. 510 U.S. 1091 (1994)). 12 Importantly, Linda’s MQMB status does not limit the Medicaid services to

which she is entitled as she remains eligible for the full scope of Medicaid benefits,

in addition to her Medicare benefits. If an item of DME is not available through

Medicare, Medicaid remains a source for this service. 1 TEX. ADMIN. CODE §§

354.1041(2)(B); 355.8021(b)(2-3). Moreover, Linda’s MQMB status does not

alter the fact that she is required to follow the same process for obtaining a custom

power wheelchair through Medicaid as all other beneficiaries. A description of

this process, which consists of four sequential steps, demonstrates the ripeness of

Linda’s case. 1 TEX. ADMIN. CODE § 354.1040.

First, a Medicaid beneficiary must undergo a clinical assessment by a

licensed occupational or physical therapist and a qualified rehabilitation

professional (QRP). Next, a Medicaid-enrolled DME supplier must submit a prior

authorization request, including the clinical assessment, a physician’s attestation of

medical necessity, a detailed description of the wheeled mobility system and all

medically necessary components or accessories, and any other documentation

required to explain the medical necessity of the requested equipment. 1 TEX.

ADMIN. CODE § 354.1040(d)(3). If prior authorization is granted, the DME

supplier orders and delivers the authorized wheelchair to the beneficiary. Once the

wheelchair is delivered, the DME supplier completes the final step – submission of

the claim for payment. 1 TEX. ADMIN. CODE § 354.1040(g). In instances where “a

13 third party health insurer is identified, [suppliers] are required to bill the third party

health insurer before submitting a claim for payment to the Commission…”7 1

TEX. ADMIN. CODE § 354.2321(b).

Here, HHSC’s ripeness argument erroneously conflates the prior

authorization step in this process, which occurs before the wheelchair is provided,

with the final step, payment of the supplier’s claim. This argument is not new. In a

similar administrative case, New York Medicaid refused to process the DME prior

authorization request of a dually-eligible beneficiary claiming she “was required to

explore Medicare approval first because [Medicaid] is the payor of last resort.”

Rejecting this argument, the Commissioner explained:

The issue here is a request for prior approval, not a request for payment. Although the Medical Assistance program is the payor of last resort, the question of payment is not relevant to the issue of prior approval . . . [t]he Appellant is entitled to have the Agency determine whether the walker is medically necessary, which is a separate and distinct question from the amount of Medical Assistance payment, if any.

Puglisi App. 7.

Similarly, Connecticut settled a lawsuit challenging this same practice by the

state’s Medicaid program, clarifying in statute that the DME prior authorization

7 “The Commission may be billed for the difference between the amount paid by the third party health insurer and the Medicaid payable amount…” 1 TEX. ADMIN. CODE § 354.2321(f). 14 process must be available to dually eligible beneficiaries.8 As explained in Conn.

Gen. Stat. Sec. 17b-281a, “[a]ccess to [the DME preauthorization process] shall

not be denied to a recipient on the basis that a Medicare determination has not been

made prior to the submission of a request for preauthorization to the

commissioner.”

Regardless of Linda’s MQMB status, the facts underlying HHSC’s unlawful

denial of Medicaid prior authorization remain ripe. Until HHSC authorizes the

recommended wheelchair, Linda is unable to proceed any further in the agency’s

four-step process for obtaining a custom power wheelchair. The DME supplier

cannot deliver the wheelchair or request payment first from Medicare, the primary

payor, and then from Medicaid, the secondary one.

On the merits of the case, the trial court correctly found that HHSC’s

decision sustaining Molina’s prior authorization denial failed “to comply with

controlling and applicable federal and state law, and thus, is arbitrary, capricious,

and unreasonable.” The court properly limited its decision to this issue, stating that

“[b]ecause this DME item must [be] prior authorized from Texas Medicaid, the

Court reverses the administrative decision of the Texas Health and Human

Services Commission on [the] prior authorization [question] presented.” HHSC

8 Frank v. Thomas, No. 3:98CV00306(GLG), U.S. Dist. Ct., D. Conn. 1998 (class action brought by an individual with a disability who was denied Medicaid prior authorization of a standing wheelchair because of her dual eligibility status.

15 App. 10. Once HHSC issues Medicaid prior authorization, the wheelchair can be

provided to Linda. Only then can the DME supplier request payment, first through

Medicare and then through Medicaid.

In determining the ripeness of a case, courts may consider “the importance

of the interest advanced [and] the extent of the injury…” Perry v. Del Rio, 66

S.W.3d 239, 251-52 (Tex. 2001), citing 13 Charles Alan Wright, Arthur R. Miller,

& Edward H. Cooper, FEDERAL PRACTICE AND PROCEDURE § 3532.1, at

130 (2d ed.1984). Here, the injury caused by HHSC's erroneous hearing decision

is a harsh one. Linda first requested prior authorization of the recommended

wheelchair in April 2013. During this time, she has had to rely upon a loaner

wheelchair that is not customized to meet her needs. Requiring her to begin the

process again, starting with a new evaluation and a new request for Medicaid prior

authorization, would subject her to further delay during which time she will not

have access to the medically necessary wheelchair she requires to address her

many medical conditions. The facts underlying this case are ripe and the trial

court's decision denying HHSC's motion to dismiss should be affirmed.

B. The Trial Court Correctly Reversed and Remanded the Case to HHSC for Further Proceedings Consistent with Its Decision.

HHSC takes issue with the trial court’s reversal of the agency’s hearing

decision and remand for agency action consistent with this decision. According to

HSHC, the “REVERSAL component of the order [ ] is in conflict with the 16 ‘REMAND’ component.” HHSC Brief, p. 12. This is incorrect. The trial court

was careful to consider and decide the central issue before it - whether HHSC

erroneously sustained Molina’s denial of Linda’s prior authorization request.

Having properly found that HHSC’s hearing decision was “arbitrary, capricious,

and unreasonable” and “unsupported by substantial evidence,” the trial court

correctly remanded the case for the agency to issue Medicaid prior authorization of

the recommended wheelchair.

HHSC’s claim that the agency should have the opportunity to take additional

evidence on remand is wrong. HHSC Brief, p.13. There is no dispute that Linda

became eligible for Medicare in May 2014 or that she is entitled to the full scope

of benefits available through Medicaid and Medicare. Moreover, there is no law or

policy that requires Medicare authorization of DME to be requested before seeking

prior authorization from Medicaid. Finally, there is no question that once the

recommended wheelchair has been delivered to Linda, the DME supplier must first

bill Medicare before submitting a claim to Medicaid.

Linda’s MQMB status has no bearing on her right to Medicaid prior

authorization of the requested wheelchair. Thus, the trial court correctly rejected

HHSC’s request to remand the case so it could “change its findings and decision.”

HHSC’s Brief, p.13. There are no new facts to be determined, no new legal

requirements to be applied in this case. Given the express language of the court’s

17 order, HHSC’s assertion that “the trial court failed to consider Puglisi’s dual

eligible status in the context of the suit for judicial review” has no merit. HHSC

Brief, p. 12.

C. Deference is Not Owed to HHSC’s Post-Hoc Interpretation of Agency Rules.

HHSC next maintains the trial court failed to defer to the agency’s

interpretation of 1 TEX. ADMIN. CODE §§ 354.1039(a) and 354.1039(a)(4)(a) in

reversing its hearing decision. Again, this argument has no merit. Neither of these

rules were identified by Molina as the legal basis for denying Linda’s prior

authorization request. HHSC App. 1. Yet, federal Medicaid regulations require the

Medicaid agency or its designee to identify the “specific regulations that

support…the action” in its notice of adverse action. 42 C.F.R. § 431.210(c).

Similarly, neither HHSC’s hearing officer nor reviewing attorney mentioned these

rules, let alone cited them as the legal basis for sustaining Molina’s prior

authorization denial. HHSC App. 2, 3. HHSC has no credible complaint that the

trial court failed to defer to the agency’s interpretation of rules that were never

identified as the basis for HHSC’s hearing decision.

This Court’s decision in Sw. Pharmacy Solutions, Inc. v. Texas Health &

Human Servs. Comm’n, 408 S.W.3d 549 (Tex. App. 2013), review denied (Nov.

22, 2013) does not support HHSC’s position. The present case is not about

construction of a statute or rule that expressly excludes wheelchair standing 18 features as no such law exists. To the contrary, applicable statute and rules

specifically support Medicaid coverage of this specialized component. It is only

TMHP policy that states otherwise, in conflict with Texas Medicaid law. As this

Court explained, “an agency’s interpretation of a statute it is charged with

enforcing is entitled to ‘serious consideration,’ so long as the construction is

reasonable and does not conflict with the statute’s language…" "We defer to an

agency’s interpretation of its own rules unless it is plainly erroneous or contradicts

the text of the rule or underlying statute.” (citations omitted) Id. at 557-58. See

also Tarrant Appraisal Dist. v. Moore, 845 S.W.2d 820, 823, (Tex. 1993) citing

Stanford v. Butler, 181 S.W.2d 269, 273 (Tex.1944).

Here, the agency’s post hoc interpretation of the above-cited rules

contradicts the plain language of TEX. HUM. RES. CODE § 32.0425 and 1 TEX.

ADMIN. CODE § 354.1040, which broadly define custom wheelchairs to include

other complex or specialized components. HHSC’s claim that 1 TEX. ADMIN.

CODE § 354.1039(a) allows the agency to exclude complex or specialized

wheelchair components is wrong and is not entitled to “serious consideration” or

deference by any court.

The same is true about HHSC’s interpretation of 1 TEX. ADMIN. CODE §

354.1039(a)(4)(A), which requires, among other things, that DME be medically

necessary. Molina did not apply either medical necessity standard established in

19 Medicaid rule and policy in this case. AR 326, Response to Interrogatory No. 6.

Nor did HHSC’s hearing officer and reviewing attorney. HHSC App. 2, 3.

Nowhere does HHSC determine whether the recommended power wheelchair with

all prescribed components is required “to correct or ameliorate [Linda’s] disability,

medical condition, or illness, 2013 TMPPM DME Handbook §2.2.2, or will “serve

a specific medical purpose.” 1 TEX. ADMIN. CODE § 354.1039(a)(4)(D). The trial

court’s judgment that HHSC’s hearing decision is arbitrary and capricious is fully

supported by the administrative record in this case.

D. The Trial Court Correctly Determined that HHSC’s Hearing Decision Fails to Comply with Medicaid Law. HHSC also defends its hearing decision by claiming it complies with 1 TEX.

ADMIN. CODE §§ 354.1031, .1035, .1039 and .1040 but fails to explain how this is

so. In fact, there is no credible support for this claim. The first rule, 1 TEX.

ADMIN. CODE § 354.1031(b)(12), defines DME and governs whether an item of

medical equipment is “covered” by Texas Medicaid. As explained by CMS,

medical equipment satisfying the state’s DME definition is “to be provided to

individuals (of any age) meeting the State’s medical necessity criteria." Puglisi

App. 1. Yet, neither Molina nor HHSC applied the state's DME definition to the

wheelchair standing feature to determine whether it is covered through the home

health benefit. HHSC App. 1, 2, 3.

20 Next, 1 TEX. ADMIN. CODE § 354.1035 sets out the qualifications for home

health services, only two of which - coverage and medical necessity - were

identified as the basis for Molina’s denial of Linda’s prior authorization request.

HHSC’s argument to the contrary is incorrect.

Finally, both 1 TEX. ADMIN. CODE §§ 354.1039 and .1040 fully support

Medicaid coverage of the requested wheelchair and its components, not HHSC’s

finding of non-coverage. These rules define custom wheelchairs available through

Texas Medicaid to include “medically justified equipment” and “complex or

specialized components.” The application of these rules to the requested

wheelchair standing feature establishes its coverage as DME. HHSC’s decision to

the contrary is arbitrary and capricious. See Rodriguez v. Serv. Lloyds Ins. Co.,

997 S.W.2d 248, 255 (Tex. 1999) (stating an agency’s action will be reversed as

arbitrary and capricious when the agency fails to follow “the clear, unambiguous

language of its own regulation.”)

HHSC’s claim that Linda failed to satisfy the necessary prerequisites for

prior authorization of DME is wholly unsupported by the administrative record.

Moreover, the agency’s suggestion that Linda is not eligible for the requested

wheelchair because “the home health agency must obtain prior authorization”

completely misses the point of this case. From the outset, Linda has challenged

Molina’s denial of prior authorization for the custom wheelchair recommended by

21 her treating medical providers. The trial court correctly found Linda has

established her right to Medicaid prior authorization of this wheelchair.

E. The Trial Court Correctly Determined that HHSC’s Hearing Decision is Arbitrary, Capricious, Unreasonable and Unsupported by Substantial Evidence.

1. The Trial Court Properly Addressed the Two Reasons Molina Denied Linda Puglisi’s Prior Authorization Request.

Molina’s denial of Linda’s prior authorization request for a custom power

wheelchair with integrated standing feature raised two issues. HHSC App. 1. The

first - Medicaid coverage of the standing feature - is a legal question the trial court

correctly resolved by finding that “HHSC’s administrative decision fails to comply

with the controlling federal and state law, and thus, is arbitrary, capricious, and

unreasonable.” The second – Linda’s medical need for the recommended

wheelchair - is a question of fact the trial court resolved based upon the probative

evidence submitted by Linda’s medical providers and Molina’s failure to refute

this evidence. On this issue, the trial court correctly determined that HHSC’s

decision was not supported by substantial evidence. HHSC App. 10, CR 348-349.

On appeal, HHSC claims the trial court failed to decide the “salient question

[ ] whether Puglisi is required to satisfy all or only part of the regulatory

prerequisites necessary to acquire the requested DME.” HHSC’s Brief, p. 17. This

is wrong. The trial court correctly decided the two issues raised by Molina in its

22 denial notice, addressed by Molina at the hearing, and decided in the agency’s

hearing decision.

HHSC’s description of additional “regulatory prerequisites” is also wrong.

Linda was not required to establish, nor was the trial court required to determine,

that the recommended wheelchair is “reimbursable DME.” As explained in

Detgen v. Janek, 945 F. Supp. 2d 746, 758 (N.D. Tex. 2013), “claimants ought not

be required to assure HHSC during the prior authorization process that [federal

reimbursement] will be available for items they request.” HHSC App. 12. This is

particularly true given that CMS directly informed HHSC that “federal

reimbursement is available to the state to the extent that [an] item is determined to

be covered.” Puglisi App. 1. Simply put, Medicaid reimbursement is available for

medical equipment that meets the state’s definition of DME.9

HHSC’s assertion that the trial court failed to decide if there was adequate

documentation of “appropriateness” is equally unpersuasive. Molina did not deny

Linda’s prior authorization request on this basis and HHSC did not address

“appropriateness” in its decision. Clearly, the trial court was not obliged to do so

either.

9 Linda’s undisputed evidence established that integrated standing features have been reimbursed by Texas Medicaid under the miscellaneous DME code (E1399) and the code for wheelchair standing features (E2301). See Declaration of Britt Sitzes, AR 289-290, ¶4; Declaration of Nancy Rice, AR 291-292, ¶¶ 5&6. 23 Finally, HHSC’s claim that the trial court failed to consider whether Linda

“had received prior authorization” once again ignores the fact that Linda's

entitlement to Medicaid prior authorization of the recommended wheelchair was

the central issue before the trial court. It goes without saying that Linda had not

received Medicaid prior authorization before filing this case in the district court.

HHSC’s claim that the trial court erred by “discarding” these additional

“regulatory prerequisites” has no merit.

2. HHSC Failed to Address Linda Puglisi's Medical Need for a Custom Power Wheelchair with Integrated Standing Feature.

HHSC failed to apply its own medical necessity standards to determine

whether the evidence submitted by Linda’s medical providers established that a

custom power wheelchair with integrated standing feature will correct or

ameliorate her disability or medical condition or will serve a specific medical

purpose for her. 2013 TMPPM DME Handbook, §2.2.2; 1 TEX. ADMIN. CODE

§354.1039(a)(4)(D). To be clear, HHSC made no decision whether the standing

feature of the recommended wheelchair is medically necessary for Linda even

though standing is the essential wheelchair function she requires to address her

numerous medical conditions caused or exacerbated by prolonged sitting day in

and day out. The agency failed to address this critical issue, and instead, limited its

medical necessity determination to the wheelchair base and seat elevator, two parts

of the wheelchair that are required to operate the standing function of the 24 recommended wheelchair. This fundamental error, and others, justified the trial

court's reversal of HHSC’s decision

The administrative record demonstrates that Linda’s well-qualified health

care providers submitted ample evidence of her medical need for the recommended

wheelchair.10 This documentation established that Linda suffers from numerous

medical conditions secondary to quadriplegia and prolonged sitting (12 hours) in a

wheelchair every day. These conditions include osteopenia and an increased risk

for bone density loss, compromised soft tissue integrity, impaired integumentary

sensation and respiratory function, neurogenic bowel, and neurological pain.

Puglisi App. 2, p.50, ¶2. As a result, Linda has a medical need to stand numerous

times throughout the day to address the adverse effects of these serious medical

conditions. According to Linda’s physician:

This increased frequency of standing will maximize the medical benefits of standing, including but not limited to, providing complete pressure relief from prolonged sitting, maintaining bone density,

10 In the Medicaid program, treating medical professionals play a central role in determining their patient's medical needs. As described in the legislative history of the Medicaid Act:

The committee’s bill provides that the physician is to be the key figure in determining utilization of health services - and provides that it is a physician who is to decide upon admission to a hospital, order tests, drugs and treatments, and determine the length of stay. For this reason the bill would require that payment could be made only if a physician certifies to the medical necessity of the services furnished.

S.Rep. No. 404, 89th Cong., 1St Sess., reprinted in 1965 U.S.C.C.A.N. 1943. See Weaver v. Reagan, 886 F. 2d 194, 200 (8th Cir. 1989), (“[t]he Medicaid statute and regulatory scheme create a presumption in favor of the medical judgment of the attending physician in determining the medical necessity of treatment.) 25 decreasing muscle tone, improving circulation, increasing respiratory function, and maintaining/improving range of motion to hips, knees, and ankles. Reducing or eliminating the occurrence of these medical complications from prolonged sitting will help Linda maintain her health and well-being and decrease the associated costs of her future medical care. Puglisi App. 2, p.51, ¶4.

Linda’s physician further made clear that “[w]ith the recommended

wheelchair, Linda will be able to stand more often and for shorter periods, making

each standing opportunity more effective in preventing bone loss and promoting

bone density.” Puglisi App. 2, p.51, ¶3. Her occupational therapist also explained

that the recommended wheelchair will enhance Linda’s “biomechanical alignment

throughout the entire body on a daily basis, which helps to prevent further impact

of spasticity on joints in upright postures.” Puglisi App. 3, p.69, ¶1.

Additionally, Linda’s physician described why a separate stander will not

meet her medical needs:

Unlike a separate stander that would require Linda to have caregiver assistance each time she uses the device, the recommended wheelchair will allow Linda to independently stand as often as possible and in any location, whether at home or in the community. Research demonstrates that short, frequent standing is more effective in improving bone density than one long standing episode. With the recommended wheelchair, Linda will be able to stand more often and for shorter periods, making each standing opportunity more effective in preventing bone loss and promoting bone density.

Puglisi App.2, p.51, ¶ 3.

Finally, Linda’s evidence established that the recommended wheelchair

requires several components, including tilt and recline, center mount articulating 26 elevating leg rests, a stand and drive leg rest assembly, and seat elevation, for the

standing feature to function. As explained, the standing system is not operational

without these components, all of which must be accommodated by a Group 4

wheelchair base. Puglisi App.2, p. 51, ¶1; App. 5, p. 293, ¶5. According to Linda’s

physician,

[T]he specific wheelchair recommended for Linda - Permobil C500VS - requires a Group 4 base, with seat elevation and integrated standing feature to permit the user to independently stand. As such, these components cannot be “removed” from the prior authorization request without substantially changing the nature of the wheelchair.

At the fair hearing, Molina failed to prove the accuracy of the medical

necessity determinations identified in its denial notice.11 Nor did Molina offer any

evidence that its medical necessity decision was made by qualified medical

professionals. While Molina’s denial notice suggests that a physician made this

decision, HHSC App. 1, their evidence established that Linda's wheelchair request

was sent to a third-party entity to determine medical need. HHSC App. 2, Finding

of Fact 5. This third-party reviewer was not a physician, an occupational therapist

or a physical therapist.12 AR 118.

Molina also was clear it did not apply Texas Medicaid’s medical necessity

standards to Linda’s prior authorization request. As they explained:

11 Pursuant to 1 TEX. ADMIN. CODE § 357.9, Molina had the burden to prove by a preponderance of the evidence that the reasons for denial identified in its notice of adverse action were factually accurate and legally correct. 12 Texas Medicaid requires that wheelchair evaluations be conducted by a licensed physical or occupational therapist or physician. 2015 TMPPM §2.2.15.10. 27 Molina utilizes the standards set forth by the National Committee for Quality Assurance (NCQA). Accordingly, the definition of “Medical Necessity” as set by NCQA as follows:

Determinations on decisions that are (or which could be considered to be) covered benefits, including determinations defined by the organization; hospitalization and emergency services listed in the Certificate of Coverage or Summary of Benefits and care or service that could be considered either covered or non-covered depending on the circumstances.13

AR 326, Response to Interrogatory No. 6.

Molina’s denial contained several erroneous statements. As to the standing

feature, Molina claimed it “is not considered medically necessary because driving

standing up is not a medical necessity.” HHSC App.1. However, Molina offered

no credible evidence to support this statement. In fact, this assertion completely

misconstrues the purpose and function of the wheelchair standing feature. Linda’s

medical professionals did not recommend this feature so Linda could drive her

wheelchair while standing.14 They recommended this feature so that Linda can

independently stand throughout the day to address the many medical conditions

she experiences as a result of prolonged sitting.

As to the seat elevator, Molina claimed “the documentation submitted did

not indicate how the power seat elevator system would promote independence.”

13 Federal Medicaid law prohibits managed care organizations from applying a more restrictive medical necessity standard than the one established in “State statutes and regulations, the State Plan, and other State policy and procedures.” 42 C.F.R. § 438.210(a)(4)(i). 14 Linda’s evidence established that “[t]he standing feature of the Permobil C500 can be used while the wheelchair is stationary or while moving at low speeds.” See Affidavit of Amy Morgan, PT. Puglisi App. 5, ¶10. 28 HHSC App.1. This statement was based on a TMHP policy governing power seat

elevators required to facilitate independent transfers. TMMPM §2.2.15.15. HHSC

App. 5. However, this policy has no relevance to Linda’s medical need for a

standing wheelchair as the seat elevator was not requested for transferring. It was

requested because the standing feature of the recommended wheelchair will not

operate without it.

Importantly, Molina did not refute the medical evidence submitted by

Linda’s medical providers or dispute their professional opinions that frequent daily

standing is required to address her numerous medical conditions. In fact, Molina

conceded Linda’s medical need to stand by suggesting she obtain a separate

standing device.15 HHSC App. 2, Finding of Fact 10.

Moreover, Molina did not dispute the evidence establishing that Linda

cannot access a separate stander on her own due to the severity of her disability

and that she lacks sufficient personal care providers to assist her with using such

equipment numerous times throughout the day. Puglisi App. 2, p. 50, ¶3; HHSC

App. 2, Finding of Fact 10. Even Molina’s third-party reviewer did not conclude

that a separate stander was sufficient to meet Linda’s needs. Rather, he

acknowledged the opinion of Linda’s medical providers “that the member is unable

15 According to Texas Medicaid policy, separate standers are approved to address medical needs like those experienced by Linda, e.g. “improve digestion, increase muscle strength, decrease contractures, increase bone density, and minimize decalcification (this list is not all inclusive).” TMPPM DME Handbook, §2.2.15.22.1. 29 to reap [the] benefits [of standing] unless they have the stander on their chair…”

AR 118, ¶4.

Like Molina, HHSC failed to apply the agency’s medical necessity standards

established in Texas Medicaid rule and policy. HHSC did not determine whether

the recommended custom power wheelchair with integrated standing feature will

correct or ameliorate the medical conditions documented by Linda’s medical

professionals or will serve a specific medical purpose for her. HHSC did not

address Molina’s assertion that “driving while standing is not a medical necessity”

and ultimately, made no decision whether the standing feature is medically

necessary for Linda. It is this essential feature, however, that was recommended

by Linda’s medical providers to address her numerous medical conditions caused

or exacerbated by prolonged sitting day in and day out.

HHSC also erroneously determined that a seat elevator is not medically

necessary because it “will not facilitate independent transfers to and from the

wheelchair for Appellant.” HHSC’s App. 2. Again, this determination ignores the

critical fact that a seat elevator was included in the prior authorization request

because the recommended wheelchair will not stand without it. Certainly, Molina

made no attempt to disprove Linda’s evidence that the seat elevator ensures “the

anterior stability of the wheelchair by allowing the caster wheels to be in contact

with the ground” when standing. Puglisi App. 5, ¶ 5.

30 Although HHSC’s hearing officer limited his medical necessity

determination to the seat elevation device, HHSC’s reviewing attorney went one

step further. Completely ignoring Linda’s medical need for the standing feature,

he determined that Linda did not qualify for the Group 4 base on the recommended

wheelchair. HHSC App. 3. While acknowledging that “the integrated standing

feature and seat elevation system are not available with the Group 3 custom power

wheelchair, HHSC App. 3, Finding of Fact 7, he ignored the fact that Molina did

not deny prior authorization of the Group 4 base on the basis of medically

necessity. Faced with insufficient medical evidence to support Molina’s denial,

HHSC’s reviewing attorney fashioned a new rationale for the denial, in violation of

Linda’s due process right to timely and adequate notice of all reasons for the

denial, with supporting legal citation, prior to the fair hearing. 42 C.F.R §§

431.210(b-c).

The bottom line is that the administrative record contains no credible

evidence refuting the professional opinions of Linda’s medical providers that a

custom wheelchair with integrated standing feature will address the “numerous

secondary medical conditions Linda faces due to her spinal cord injury” and that “a

separate stander will not provide the same medical benefits for Linda.” Puglisi

Apps. 2, 3, 6.

31 In this appeal, HHSC’s defense of its hearing decision begins with the

erroneous assertion that Linda was required to prove her medical need for a Group

4 wheelchair base. This is incorrect. As explained above, this claim was not part

of Molina’s medical necessity denial, but rather, was the post hoc invention of

HHSC’s reviewing attorney. HHSC App 3. HHSC cannot ignore the fact that

Molina’s evidence wholly failed to refute Linda’s medical need to stand and her

inability to use a separate stander and then concoct a new basis for denial after the

fair hearing. Molina’s denial notice does not cite TMPPM 2.2.14.12.5 as support

for its decision and HHSC’s argument concerning this policy has no bearing on the

outcome of this case. Molina recognized that the Group 4 wheelchair base “was

requested in order to accommodate the Power Stand and Drive function.” HHSC

App. 1. And as Molina’s outside reviewer noted, the requested wheelchair only

comes with a Group 4 base and the difference between a Group 3 and 4 base is not

a question of medical necessity. AR 118.

HHSC’s assertion that Linda was required to demonstrate that a Group 4

wheelchair base is medically necessary, i.e. will correct or ameliorate her

disability, condition, or illness, is nonsensical. The recommended wheelchair

requires many components to be operational and there is no requirement that

medical necessity be demonstrated for each and every one. The undisputed

evidence established that several identified components, as well as the Group 4

32 wheelchair base, are required to operate the standing feature of the wheelchair.

Puglisi App. 5.

HHSC’s defense of its medical necessity decision concerning the seat

elevation system fails for the same reason. It is undisputed that the power seat

elevator, like the Group 4 wheelchair base, is required to operate the standing

feature of the recommended wheelchair. HHSC cannot deny Linda’s medical need

for a custom power wheelchair with integrated standing feature because she lacks

the functional ability to perform “uphill transfers.” The agency’s reliance upon

TMPPM 2.2.14.15 to deny the recommended wheelchair wholly ignores the fact

that Linda has a medical need to stand throughout the day and the recommended

wheelchair is the only item of DME that will meet her medical needs.16

Moreover, HHSC’s argument concerning medical necessity for a seat

elevator creates an impermissible distinction between Medicaid beneficiaries based

on the severity of their disabilities. As such, individuals who have a medical need

to stand and who can perform independent transfers, “particularly uphill transfers,”

can obtain a standing wheelchair, while those with more severe disabilities who

have the same medical need to stand but lack the functional ability to self-transfer,

cannot. Under HHSC’s analysis, individuals with quadriplegia would never qualify

16 HHSC suggests Linda’s documentation “did not demonstrate how the power seat elevator system would promote independence.” This is inaccurate. Linda’s physician specifically advised that “the specific wheelchair recommended for Linda - Permobil C500VS - requires a Group 4 base, with seat elevation and integrated standing feature to permit the user to independently stand.” (emphasis added) Puglisi App. 2, ¶1. 33 for a wheelchair with integrated standing feature due to the severity of their

disabilities and their functional inability to self-transfer. While this distinction

between Medicaid beneficiaries makes no medical sense, it also violates the

Medicaid Act’s comparability requirement and its prohibition against diagnosis-

based decision making.17 HHSC cannot deny eligibility for standing wheelchairs

based upon severity of disability when there is no medical rationale to support this

distinction.

HHSC’s medical necessity arguments concerning the Group 4 power base

and seat elevator are a futile attempt to evade the fact that its hearing decision

failed to address Linda’s medical need for a custom power wheelchair with

integrated standing feature. The trial court correctly determined that HHSC’s

hearing decision is unsupported by substantial evidence.

3. HHSC Failed to Employ the Correct Test for Determining Medicaid Coverage of DME.

Medical equipment is covered through Medicaid’s home health benefit when

the item fits within the state's DME definition. Puglisi App. 1. HHSC concedes

this is the proper test for DME coverage, HHSC Brief, p.30, but ignores the fact

that both its hearing officer and reviewing attorney failed to apply this test to the

recommended wheelchair standing feature. Instead, they erroneously presumed

17 42 U.S.C. § 1396a(a)(10)(B); 42 C.F.R. § 440.240(b); See Lankford v. Sherman, 451 F.3d 496 (8th Cir. 2006) (comparability requirement violated when state covers items of DME for certain individuals with disabilities but not for others.)

34 non-coverage based upon TMHP’s policy exclusion of standing features and

sustained Molina’s coverage determination on this basis. HHSC App. 2, 3.

Contrary to HHSC’s claim, Linda has never suggested that Medicaid

coverage of the recommended standing feature should be “assumed.” Instead, she

maintains that HHSC cannot lawfully apply TMHP’s presumption of non-coverage

as it did in this case.18 Here, there is no question the standing feature meets the

state’s DME definitions and its definition of wheeled mobility systems.

HHSC relies upon Detgen v. Janek, 752 F. 3d 627 (5th Circuit 2014), to

defend its failure to correctly determine Medicaid coverage of the recommended

wheelchair component, however, this reliance is misplaced. Detgen upheld the

state’s exclusion of ceiling lifts, finding that a state can choose “by definition” to

exclude ceiling lifts from coverage. Id. at 632. Here, the opposite is true and

necessarily compels a different outcome. The Texas Legislature chose to define

custom wheelchairs to include wheelchairs with complex or specialized

components like the standing feature at issue in this case. TEX. HUM. RES. CODE §

32.0425.

Next, Detgen found the exclusion of ceiling lifts to be “reasonable” because

of the availability of “more cost effective alternatives.” According to the Court, “a

18 HHSC acknowledges that CMS reminded the agency of this specific test for DME coverage, yet inexplicably claims that TMHP’s exclusion of wheelchair standing features complies with federal policy. HHSC Brief, p. 30. HHSC makes no attempt to explain the contradiction between these two statements. 35 categorical exclusion based upon the availability of cost effective alternatives

cannot mean that the state has denied a medically necessary device.” Id. at 632.

Here, however, HHSC’s exclusion of wheelchair standing features means the state

has denied Linda a medically necessary device for which there is no alternative

that will meet her medical needs. It is undisputed that Linda cannot transfer to a

separate stander numerous times each day to correct or ameliorate her many

medical conditions caused by prolonged sitting.

Finally, Detgen is not dispositive in Linda’s case because this decision is

wrong. It is an outlier among dozens of case rejecting states’ efforts to exclude a

wide array of DME items and uniformly holding such DME exclusions to be

unlawful.19 As explained in Lankford v. Sherman, 451 F.3d 496, 511 (8th Cir.

19 See e.g., Alvarez v. Betlach, 572 F. App’x 519 (9th Cir.) cert. denied, 135 S. Ct. 870 (2014)(rejecting Arizona Medicaid’s exclusion of incontinence briefs); Lankford v. Sherman, 451 F.3d 496 (8th Cir. 2006) (rejecting Missouri Medicaid’s restrictions on DME coverage); Fred C. v. Texas Health & Human Services Comm’n, 988 F.Supp. 1032 (W.D.Tx. 1997), affirmed per curiam 167 F.3d 537 (5th Cir. 1998) (requiring coverage of augmentative communication devices as DME and prosthetic devices); Meyers v. Reagen, 776 F.2d 241 (8th Cir. 1985)(requiring coverage of augmentative communication devices that fit within the scope of the equipment included in Medicaid’s speech-language pathology service); Davis v. Shah, No. 12-CV-6134 CJS, 2012 WL 1574944, (W.D.N.Y. May 3, 2012) (rejecting exclusion of orthopedic footwear and compression stocking as DME for certain beneficiaries) Hiltibran v. Levy 793 F.Supp.2d 1108 (W.D. Mo. 2011)(granting preliminary injunction requiring coverage of incontinence aids for adults as medical equipment); Jasset v. R.I. Dept. of Hum. Serv., 2006 WL 2169891 at * 5 (R.I. Super. July 31, 2006) (citing Bristol v. R.I. Dept. of Hum. Serv., 1997 WL 839884, at *5 (R.I. Super. Jan. 30, 1997)(prohibiting intent to go to work or school as a coverage criterion for a wheelchair because neither is related to medical necessity)); Blue v. Bonta, 99 Cal.App. 4th 980, 121 Cal.Rptr.2d 483 (Cal App. 2002) (requiring coverage of stairway elevator based on Medi-Cal DME definition); T.L. v. Colorado Dept. of Health Care Policy & Fin., 42 P.2d 63 (Colo. App. 2002) (prohibiting express exclusion of whirlpool bath from consideration as DME and without consideration of medical need); Will T. v. Taylor, 465 F.Supp.2d 1267 (N.D. Ga. 2000)(requiring coverage of speech generating devices as DME, 36 2006), “[a] state’s failure to provide Medicaid coverage for non-experimental,

medically necessary services within a covered Medicaid category is both per se

unreasonable and inconsistent with the stated goals of Medicaid.”

Ignoring these many cases, the Detgen court reached a conclusion that does

not square with federal Medicaid case law or policy. This is particularly true

concerning its interpretation of the DeSario Letter. HHSC App. 6. Contrary to the

plain language of this federal guidance, the Court concluded that states are

authorized to maintain a "never approved" list of DME. Id. at 632-633. If this were

correct, the Second Circuit’s decision in DeSario v. Thomas upholding the state's

list of DME exclusions would still be good law. 139 F.3d 80 (2d Cir. 1998). But it

is not good law precisely because CMS clarified that exclusions of medical

equipment meeting the state’s definition of DME violate the Medicaid Act's

prosthetic devices and equipment under the speech-language pathology benefit); Bell v. Agency for Health Care Admin., 768 So.2d 1203 (FL. App. 2000)(requiring coverage and provision of insulin pumps when medically necessary); 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); Ohlson v. Weil, 953 P.2d 939 (Colo. App. 1997)(requiring coverage of body brace that meets Medicaid’s DME definition); Brisson v. Dep’t of Social Welf., 702 A.2d 405 (VT. 1997)(prohibiting exclusion of closed circuit television because it meets Medicaid’s definition of eyeglasses); Hunter v. Chiles, 944 F.Supp. 914 (S.D. Fl. 1996)(requiring coverage of speech generating devices as DME); Myers v. State of Mississippi 3:95 CV 185 LN (Slip Op. S.D. Miss. 1995)(requiring coverage of speech generating devices as DME); 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 necessity as decision-making standard for durable medical equipment, prosthetic devices and non-durable medical supplies); Ledet v. Fischer, 638 F. Supp. 1288, 1291 (M.D. La. 1986) (requiring coverage of eyeglasses regardless of diagnosis); Baker v. Commonwealth of Pa. Dept. of Pub. Welfare, 502 A.2d 318 (Pa. Commw. 1985) (requiring coverage of wheelchair with 500-pound carrying capacity). 37 reasonable standards requirement and implementing amount, duration and scope

rule. 42 U.S.C. § 1396a(a)(17); 42 C.F.R. § 440.230(b-c). Relying upon this

federal guidance, the Supreme Court vacated the Second Circuit’s decision

upholding Connecticut Medicaid’s list of DME exclusions. Slekis v. Thomas, 525

U.S. 1098 (1999).20

Moreover, HHSC cannot claim to be in compliance with the DeSario

Letter’s requirement that states establish “reasonable and meaningful” procedures

for making individualized determinations of DME coverage, while arguing that

Linda’s access to this process was not warranted. HHSC Brief, p. 26. According to

1 TEX. ADMIN. CODE § 354.1039(a)(4)(D), medical equipment may be covered

when it is medically substantiated that the requested item would “serve a specific

medical purpose on an individual case basis.” (Emphasis added.) Molina failed to

apply this standard to Linda’s wheelchair request.21 HHSC failed to do so, as well.

HHSC cannot evade this fact by claiming that “Puglisi did not request exceptional

circumstances review of her request for an integrated standing feature.” HHSC

Brief. p. 25-26. It was incumbent upon Molina and HHSC to apply the correct

medical necessity standards to Linda's prior authorization request.

20 The Supreme Court Order stated: [P]etition for certiorari granted. Judgment vacated, and case remanded to the United States Court of Appeals for the Second Circuit for further consideration in light of the interpretive guidance issued by the Health Care Financing Administration on September 4, 1998. (emphasis added). 21 When asked in discovery whether an exceptional circumstances review of Linda’s prior authorization request had been conducted, Molina objected to the question and provided no response. AR 327, Response to Interrogatories No. 10 and 11. 38 HHSC’s assertion that Linda relies upon a “vacated opinion and judgment”

to support her position that a wheelchair standing feature is covered by Medicaid is

incorrect.22 HHSC Brief, p.28. As explained above, Linda relies on federal

Medicaid policy and dozens of federal and state court decisions spanning more

than 30 years, all of which make clear that states must cover items of medical

equipment that meet their DME definitions. See n.19 supra. And as explained

above, CMS recently reminded HHSC of this Medicaid test for DME coverage.

Puglisi App. 1. There is no excuse for HHSC’s failure to apply this DME coverage

test in Linda’s case.

HHSC devotes a considerable amount of its brief defending its erroneous

coverage determination by attempting to refute an argument Linda has never made.

To be clear, Linda did not file a rule challenge pursuant to TEX. GOV’T CODE §

2001.038. CR 3-31. Nor did she ask the trial court to invalidate Medicaid rules, 1

TEX. ADMIN. CODE §§ 1031, .1035, .1039, and .1040, or “to modify the Medicaid

Home Health Services program.” HHSC Brief, p. 30-31. As explained in Section

D. above, Linda has no complaint with these rules as each supports her entitlement

22 HHSC acknowledges that the three “errors” identified by the Fifth Circuit in Koenning v. Suehs, 897 F. Supp.2d 528 (S.D. 2012), vacated and dismissed as moot, sub nom. Koenning v. Janek, 539 Fed. Appx. 353 (5th Cir. 2013) did not relate to the merits of the decision. HHSC Brief, p. 28. Moreover, the Fifth Circuit found the case was moot because, on remand, Medicaid had approved standing wheelchairs for two of the plaintiffs and afforded a fair hearing to the third plaintiff on the issue of medical necessity. As described by the district court, two of the plaintiffs had significant spinal cord injuries and severe functional limitations. 897 F. Supp. 2d at 545-536. These functional limitations are much like those experienced by Linda Puglisi, yet Texas Medicaid eventually authorized standing wheelchairs for all of the Koenning plaintiffs. 39 to Medicaid prior authorization of a custom power wheelchair with integrated

standing feature. Rather, Linda asked the trial court to reverse HHSC’s hearing

decision because the agency failed to properly apply these rules, and the criteria

established therein, to her prior authorization request. HHSC’s protracted

arguments concerning rule challenges under TEX. GOV’T CODE § 2001.038,

including the redundant remedies doctrine and the constitutional separation of

powers requirement, have no bearing on this case and require no response.

HHSC’s Brief, pp. 30-41.

While Linda does not challenge the legality of HHSC’s DME rules, she does

maintain that TMHP’s policy excluding wheelchair standing features from

Medicaid coverage conflicts with these rules, and as such, is an invalid basis for

HHSC’s decision on this issue. Failing to apply the correct test for Medicaid

coverage of the recommended standing feature, HHSC regarded TMHP’s policy

exclusion of wheelchair standing features as binding on its decision and concluded

that “mobile standers, power standing systems on a wheeled mobility device are

not a benefit of Home Health Services.” HHSC App. 2, Conclusion of Law; App.

3, Conclusion of Law 3. The agency ignored the fact that the recommended

standing feature is a specialized wheelchair component and specialized

components for custom wheelchairs are authorized for Medicaid coverage by

40 statute and rule. TEX. HUM. RES. CODE § 32.0425; 1 TEX. ADMIN. CODE §

354.1040.

TMHP’s exclusion of wheelchair standing features meets all of the criteria

of a “rule” identified in the Texas Administrative Procedures Act (APA), but was

not promulgated in compliance with the Act. Pursuant to TEX. GOV’T CODE §

2001.003(6), a “rule” is defined as:

(A) a state agency statement of general applicability that: (i) implements, interprets, or prescribes law or policy; or (ii) describes the procedure or practice requirements of a state agency; (B) includes the amendment or repeal of a prior rule; and (C) does not include a statement regarding only the internal management or organization of a state agency and not affecting private rights or procedures.

TMHP’s policy clearly meets these criteria. First, this exclusion is a

“statement of general applicability” interpreting law or policy and affecting all

Medicaid beneficiaries in need of this custom wheelchair. See Texas Alcoholic

Beverage Comm’n v. Amusement & Music Operators of Tex., Inc., 997 S.W.2d

651, 658 (Tex. App.—Austin 1999, pet. dism’d w.o.j.) (finding statements in

agency memoranda were rules because they imposed binding instructions affecting

private rights of all similarly situated persons.) As HHSC’s decision demonstrates,

this policy exclusion dictates a specific result - a finding of non-coverage of the

standing feature - without regard to the required test for Medicaid DME coverage.

41 Both HHSC’s hearing officer and reviewing attorney regarded this policy as

binding on their decision concerning Medicaid coverage in this case.23

Next, TMHP’s policy limits the scope of custom wheelchair coverage and

essentially amends Texas law defining both DME and custom wheelchairs. The

plain language of TEX. HUM. RES. CODE § 32.0425 and 1 TEX. ADMIN. CODE §

354.1040 makes clear that Medicaid coverage of custom power wheelchairs

includes wheelchairs with “complex or specialized components” like the one

recommended by Linda’s treating medical providers.

Finally, this policy is not a “statement regarding only the internal

management or organization” of HHSC, but rather, is a bright-line rule the agency

claims is dispositive on the question of Medicaid coverage of wheelchair standing

features. See Combs v. Entertainment Publications, Inc., 292 S.W. 3d 712, 722

(Tex. App.—Austin 2009, no pet.) (holding Comptroller’s policy statement invalid

because it was not properly promulgated pursuant to the APA.)

Neither HHSC nor its contractors can limit the scope of the custom

wheelchair benefit by establishing a policy that conflicts with the express language

of state law and agency rules. Yet, TMHP’s exclusion of wheelchair standing

components does just that. This policy fits squarely within the Texas APA’s

23 Pursuant to 1 TEX. ADMIN. CODE § 357.703(b)(3), HHSC’s attorney was required to “review[ ] the hearing decision for errors of law and fact . . . .” Like the hearing officer, however, he failed to apply the test for DME coverage established in federal policy and to determine the legality of TMHP’s policy exclusion of wheelchair power standing features. 42 definition of a rule, but was not promulgated pursuant to law.24 As such, it is an

invalid basis for the agency’s decision that the requested wheelchair standing

feature is not a covered benefit. See El Paso Hosp. Dist. v. Texas Health and

Human Servs. Comm’n, 247 S.W. 3d 709, 714 (Tex. 2008) (holding HHSC’s

policy establishing a cut-off date for Medicaid hospital claims that did not appear

in the agency’s base-year rule was not properly promulgated under the APA.)

This Court’s recent decision in Texas State Bd. of Pharmacy v. Witcher, 447

S.W.3d 520, 535 (Tex. App. 2014), supports this conclusion. There, the plaintiff

sought review of the Texas Board of Pharmacy’s final administrative decision

suspending her license. Witcher argued that the Board’s reliance on a policy

mandating this penalty was arbitrary and capricious and the result of improper ad-

hoc rulemaking. Agreeing with Witcher, this Court upheld the district court’s

decision finding that the Board’s “policy” was, in fact, an improperly promulgated

“rule” under the APA, and an invalid basis for the imposed penalty.

The same is true here. There is no statute or regulation that supports

HHSC’s decision concerning Medicaid coverage of the requested standing feature.

To the contrary, the requested wheelchair component fits within the applicable

24 The APA requires state agencies to provide notice and the opportunity for public comment so that affected persons can be heard on proposed rules. See TEX. GOV’T CODE §§ 2001.023–.030. “The Legislature delegates formal rulemaking power to an agency in the expectation that an agency will ordinarily adopt rules of general application through that power.” Rodriguez v. Serv. Lloyds Ins. Co., 997 S.W.2d 248, 255 (Tex. 1999).

43 definitions found in state law and regulation. Yet, HHSC treated TMHP’s policy

exclusion as binding on its decision concerning Medicaid coverage. “Arbitrary

and capricious agency action [ ] may be found when an agency improperly bases

its decision on non-statutory criteria.” Public Utility Commission v. South Plains

Electric Cooperative, Inc., 635 S.W.2d 954, 957 (Tex.App.—Austin 1982, writ

ref'd n.r.e.).

In sum, HHSC failed to apply the longstanding test for Medicaid coverage of

DME, and instead, relied upon an unlawful exclusion that violates the requirements

of both the Texas APA and the reasonable standards requirement of the Medicaid

Act. 42 U.S.C. § 1396a(a)(17). HHSC ignored the scope of the custom wheelchair

benefit established by the Texas legislature and violated the Medicaid Act’s

amount duration and scope rule. 42 C.F.R. § 440.230(b-c). The recommended

wheelchair, with all of its custom components, meets HHSC’s DME definitions

and fits within the custom wheelchair benefit established in state law. HHSC’s

conclusion that the recommended standing feature is not covered through the

Medicaid home health benefit is wrong. CR 348-349. Having found that HHSC’s

decision failed “to comply with controlling applicable federal and state law,” the

trial court correctly reversed the agency’s decision on the issue of Medicaid

coverage.

44 F. HHSC Violated Linda Puglisi's Procedural Due Process Rights.

It is well established that individuals who apply for or receive public

assistance such as Medicaid are entitled to certain due process protections,

including legally sufficient notice and the opportunity for a fair hearing, when they

are denied this assistance by the state. Goldberg v. Kelly, 397 U.S. 254, 90

S.Ct.1011, 25 L.Ed.2d 287 (1970); U.S. CONST. amend. XIV; 42 U.S.C. §

1396a(a)(3); 42 C.F.R. § 431.200 et seq. While the trial court did not address the

due process violations asserted in this case, the hearing record demonstrates that

HHSC failed to enforce Linda’s due process right to legally sufficient notice and

further exacerbated this violation by sustaining the denial of Linda’s prior

authorization on grounds not identified in Molina’s notice of adverse action.

1. Medicaid Beneficiaries Have a Protected Property Interest in Their Medicaid Benefits.

HHSC’s assertion that Linda has no protected property interest in her

Medicaid benefits is incorrect. As explained in Jonathan C. v. Hawkins, No. CIV

A 9:05-CV-43, 2006 WL 3498494,*12 (E.D. Tex. Dec. 5, 2006):

Courts view welfare entitlement more like “property”, rather than a “gratuity”, and such benefits are a matter of statutory entitlement for persons qualified to receive them. Therefore, under the law, beneficiaries do, in fact, have a constitutionally protected property interest in Medicaid benefits. (Citations omitted)

See also Hamby v. Neel, 368 F.3d. 549, 559 (6th Cir. 2004); Thompson v. Roob,

2006 WL 2990426, at *5-6 (S.D. Ind. Oct. 19, 2006); Ladd v. Thomas, 962 F. 45 Supp 284, 289 (D. Conn. 1997); Ability Center of Toledo v. Lumpkin, 808

F.Supp.2d.1003 (N.D. Ohio 2011); Fishman v. Daines, 743 F.Supp.2d. 127,146

(E.D. N.Y 2010).

HHSC’s next assertion that Linda “has never acquired the benefits of this

Medicaid program” is also incorrect. Unlike the Medicaid applicants in Johnson v.

Guhl, 91 F.Supp. 2d 754 (D. N.J. 2000), Linda has received Medicaid benefits

since shortly after her injury in 2011. Moreover, Medicaid beneficiaries denied

DME requested through the state’s prior authorization procedures are entitled to

due process. See Ladd v. Thomas, 962 F. Supp. 284 (D. Conn. 1997) (holding

Hamby v. Neel, 368 F.3d 549, 559 (6th Cir. 2004), (holding plaintiffs had a

property interest in the [Medicaid] coverage for which they hope to qualify.)

HHSC’s own rule also establishes this right. 1 TEX. ADMIN. CODE §

357.3(b)(1)(E).

HHSC’s reliance on case law involving the denial of professional licenses,

Neuwrith v. Louisiana State Bd. of Dentistry, 845 F. 2d 553 (5th Cir. 1988),

termination from employment, Woody v. Dallas, 809 F. Supp. 466 (N.D. Tex.

1992), or the distribution of insurance payments, Liberty Mut. Ins. Co. v. Texas

Dep't of Ins., 187 S.W. 3d 808 (Tex. App. Austin 2006, pet denied) is misplaced

and has no bearing on Linda’s due process rights as a Medicaid beneficiary.

46 2. Molina's Denial Notice does not Comport with Due Process and HHSC Failed to Address this Issue.

HHSC and its contracted entities are required to afford due process to

Medicaid beneficiaries when their “claim for medical assistance under the plan is

denied or not acted upon with reasonable promptness.” 42. U.S.C. § 1396a(a)(3);

42 C.F.R. § 431.200 et seq.; 42 C.F.R. § 438.404; 1 TEX. ADMIN. CODE §

357.3(b)(1)(E). Included within these due process rights is the right to legally

sufficient notice that contains, among other things, “the reasons for the intended

action” and the “specific regulations that support…the action.” 42 C.F.R §§

431.210(b) and (c). The reason for this required content is clear. As explained by

the court in Gray Panthers v. Schweiker, 652 F. 2d 146, 158 (D.C. Cir. 1980):

It is universally agreed that adequate notice lies at the heart of due process. Unless a person is adequately informed of the reasons for denial of a legal interest, a hearing serves no purpose and resembles more of a scene from Kafka than a constitutional process. Without notice of the specific reasons for denial, a claimant is reduced to guessing what evidence can or should be submitted in response and is driven to responding to every possible argument against denial at the risk of missing the critical one altogether.

Here, Molina’s denial notice failed to provide the required specificity

concerning the reasons it determined the recommended wheelchair was not

covered by Medicaid or was not medically necessary for Linda. This notice also

failed to include citations to the statutes and rules that support the cursory

explanation it did provide. In Thompson v. Roob, 2006 WL 2990426 (S.D. Ind.

47 Oct. 19, 2006), the court held that the notices issued by the Indiana Medicaid

program “violated Plaintiffs’ due process rights as a matter of law” because “[i]n

the public benefit context, procedural due process requires “ascertainable

eligibility standards” to be articulated and implemented, in order to guarantee

objectivity and provide adequate notice.” Id. at *7. Molina’s notice included no

ascertainable standards upon which its perfunctory denial was based and Linda’s

repeated request for these standards went ignored. As such, Molina’s notice of

adverse action violated Linda’s due process right to legally sufficient notice.

HHSC seeks to excuse Molina’s due process violation by pointing out that

the notice stated that Linda had the right to “obtain a copy of the guidelines used

by MHT to decide the outcome.” HHSC Brief, p. 46. Notably, the agency

overlooks the fact that Molina failed to provide the requested policies despite

repeated requests by Linda’s counsel. AR 267, 268, 276. Like Molina, HHSC also

failed to respond to Linda’s repeated requests to the hearing officer concerning

Molina’s legally insufficient notice. AR 283, 284, 285. HHSC has established

specific procedures for its hearing officers to follow when a Medicaid beneficiary

questions the legal sufficiency of a Medicaid denial notice, but HHSC ignored

these procedures in this case. Puglisi App. 8.

3. HHSC’s Administrative Review Does Not Comport with State Law and Further Compounded the Due Process Violations in this Case.

48 The final decision issued by HHSC’s reviewing attorney further

compounded the due process violations in this case. HHSC does not dispute this

point, but merely recites several provisions of state law and agency rules governing

the administrative review process. These provisions are irrelevant here as there is

no dispute that Linda filed a timely request for administrative review or that

HHSC’s reviewing attorney issued a written decision representing the final

decision of the agency. What is relevant is the action by HHSC’s attorney to go

beyond the reasons for denial identified in Molina’s notice of adverse action to

shore up support for the hearing officer’s decision in this case. HHSC App. 3,

Finding of Fact 11. Due process requires timely and adequate notice of all reasons

for the denial, with supporting legal citation, prior to the fair hearing. 42 C.F.R §

431.210(b-c). HHSC’s final decision violated this important protection for Linda

Puglisi.

PRAYER

Appellee, Linda Puglisi, respectfully requests this Court to affirm the trial

court’s decision in her favor. Appellee further requests all other relief to which she

may be entitled.

49 Respectfully Submitted,

/s/ Maureen O’Connell MAUREEN O’CONNELL Texas Bar No. 00795949 SOUTHERN DISABILITY LAW CENTER 1307 Payne Avenue Austin, Texas 78757 (512) 458-4800 (Phone) (512) 458-5850 (Fax) moconnell458@gmail.com

Attorney for Appellee

CERTIFICATE OF COMPLIANCE

1. This brief complies with the type-volume limitation of Tex. R. App.

P. 9.4(i)(2)(B) because it contains 12,058 words, excluding the parts of the brief

exempted by Tex. R. App. P. 9.4(i)(1).

2. This brief complies with the typeface requirements of Tex. R. App. P.

9.4(e) because it has been prepared in a proportionally spaced typeface using

Microsoft Word in 14 point Times New Roman.

/s/ Maureen O’Connell MAUREEN O’CONNELL

50 CERTIFICATE OF SERVICE

I hereby certify that on this 14th day of July, 2015, a true and correct copy of

the foregoing document was electronically filed, and that a true and correct copy of

the foregoing document was served by electronic mail on the same date to:

Eugene Clayborn Assistant Attorney General Office of the Attorney General P.O. Box 12548 Austin, Texas 78711

/s/ Maureen O’Connell MAUREEN O’CONNELL

51 No. 03-15-00226-CV _________________________________

IN THE THIRD COURT OF APPEALS AUSTIN, TEXAS _________________________________

TEXAS HEALTH AND HUMAN SERVICES COMMISSION, Appellant,

v.

LINDA PUGLISI, Appellee. _________________________________

On Appeal From The 53rd Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-000381 The Honorable Judge Gisela D. Trianna _________________________________

APPELLEE’S APPENDIX _________________________________

MAUREEN O’CONNELL Texas Bar No. 00795949 SOUTHERN DISABILITY LAW CENTER 1307 Payne Avenue Austin, Texas 78757 T: 512.458.5800 F: 512.458.5850 moconnell458@gmail.com Attorney for Appellee APPENDIX INDEX

CMS Letter to Texas Medicaid, May 21, 2013 ................................................. Tab 1 Letter of Medical Necessity, Dr. Lisa Wenzel................................................... Tab 2 TIRR Wheelchair Evaluation ............................................................................. Tab 3 RESNA Position on the Application of Wheelchair Standing Devices, Assistive Technology, 21:161-168, 2009 ............................................ Tab 4 Affidavit of Amy Morgan, PT, ATP .................................................................. Tab 5 Letter of Medical Necessity, Dr. Lisa Wenzel................................................... Tab 6 In the Matter of Mary A., New York Dept. of Social Services.......................... Tab 7 HHSC Fair and Fraud Hearings Handbook (Excerpt) ....................................... Tab 8 TAB 1 DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & 1-fedicaid Services 7500 Security Boulevard, MailStop S2-14-26 Baltimore, Maryland 21244-1850

Center for Medicaid and CHIP Services Disabled and Elderly Health Programs Group (DEHPG)

May 21, 2013

Kay Ghahremani State Medicaid Director Texas Health and Human Services Commission Brown-Heatly Building 4900 N. Lamar Blvd. Austin, TX 78751-2316

Dear Ms. Ghahremani:

The Centers for Medicare & Medicaid Services (CMS) is writing to clarify our policy on the medical supplies, equipment and appliances (often referred to as Durable Medical Equipment, or DME) that will receive Federal reimbursement.

DME is a component of the home health benefit, which is a mandatory service within the Medicaid program. As such, items ofDME meeting the state's definition of such coverage is to be provided to individuals (of any age) meeting the State's medical necessity criteria. In addition, CMS issued a letter to State Medicaid Directors on September 4, 1998 (see attached) interpreting state re&ponsibilities in providing medical equipment in response to the DeSario ~ court decision. This guidance requires states to have a reasonable process for beneficiaries to request items ofDME not on a pre-approved list, and the ability for a beneficiary to request a fair hearing to appeal negative determinations.

We understand that the State of Texas is not approving requests for ceiling lifts provided to adult Medicaid beneficiaries, due to prior CMS guidance indicating that Federal reimbursement is not available. We are clarifying here, in a way that supersedes prior CMS guidance on this topic, that coverage of ceiling lifts under the medical equipment benefit is an issue that states must determine consistent with the process described in the September 4, 1998 guidance, and that federal reimbursement is available to the state to the extent that the item is determined to be covered. This means that medically necessary ceiling lifts will be reimbursed by CMS as part of the Texas home health benefit if these lifts meet the state's definition of DME.

In addition, we would like to make sure you're aware of a Notice of Proposed Rulemaking issued July 12, 2011. That regulation proposed changes to the home health benefit to not only codify face-to-face encounters required at section 6407 of the Affordable Care Act, but to also propose definitions of a medical supply, equipment and appliance. Also included was a proposal that any item meeting any of those definitions. must be covered under the state plan, and may not be reserved for coverage under a 1915 (c) home and community based services waiver. We are working now to issue a final regulation. We encourage you to familiarize yourself with the provisions of that proposed rule.

l

'127 I P-18 000303 ~ J

Page 2 - Ms. Kay Gha.hremani

We hope this alleviates any confusion. Don't hesitate to contact me with any questions.

Sincerely,

Isl

Melissa Harris Director Division of Benefits and Coverage

Cc: Billy Bob Farrell, Dallas Regional Office

·--------... ···------·----·-·----·-------·-------- P-18 000304 TAB 2 J Page 4of 68 received on 5110120131:33:08 PM IPacme oa~lght TlmeJ ~004/1!8

·.~1' ·-·- Piuientl · · --·-u11c1a Pugl~I .. ·-· -····---.. ---· .. --- ···- - - .------ .(la~ Qf· Bli(b: ~·!!liililllll Dlfi3hosbt'. Nouroi1bron1etosls 'l'ypo.h1 Quadrlplogla·Ol·C~ lnoo111plete . Sub]eat: Jl~spo111e to Molln~J;l~e.lthQa:e's p~i!dlii1l:/10tl9•. fi!t9.l/4tom·wh'1"lohalr w.m; pqwer stannlbll andc seat olevatton l'ohture1. · Ta whom if mil)' ooncotn:

Lind" Pust isl is twenty-siK years- old and has an urgent need for th~ ~ustorrr powe,·wh"l'lohair that wauec.enl!y.;eoorilmended :fur hO!!. Wldlo Molina Healtho-la requcsting·t~a! w<>·exclude th• "sei!t.elevc.tor" and "•tan.dins featuto and alf acoompanylnQ con;pononts" for Ms. Puglisi; wo do not •jlte•with iliese changes, ,i.s expfailJ"d b•low, 11 Is our pr.~feM.lonal epfolon: 1b3t tho . reoonmianded Wheolqhalr wtrh lnlegretod·st1µ1dlti3 f?IUre-.l11 m~loally n=sary fot thfa patlent Oil it wm tlllow h¢r to Independently. stand multl~l•·llmet eat1h day·whllo at home or fn.ttte oonihlunfty, Tll!s uooess Jo fleqµen{ atand.IJli;'fa na'l11'splity to-e9trec\ lit. Msfcoponlo and ls Ill rlsk {or oontinJ.lod Jo" ot'\>onO'dens(ty. Llrida ls ah!o at inoroad6d ri•k tbr pressure so~•• due to oompromisod.s~ft tlswe'lntegrl1¥, Linda also ~xportemm Imp•~ mplratory tunolfon, nourogonto bowel, neuralogl~iil paln,.md Impaired lntp,11.umenlar;' a¢nslillon. Reconlly, Lind!!. w~• ajso di•~nosed with NaU!oilbl'o'n\atosls '.l'ype 11 (NF2).

Due \o 1!>~ n~tura \!lid severity of Illnda" 1~iuitl .oorlifr!J~ry, sM.Js.,depoJt.de.rir.on :a !!OWer. l'ltleclohaf\"for fn®pendeni mobllll)'• Tn·additfott; Lhtda0 requlm caregiver mlstanco kl itansfer !~ and"Qut cif her bod.1µ1d ytheelohaii;. She ~!so utl!fzen L~fl Mobile Ann Support ti>.lnorelj!lo fiet l'unctfiinala&llltles and to partlolpat<> In actlvlt!ef of·dally. llvlna, With ild"

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•.'f81

.·. . A.ii,-~;1d'PMJlpJ~~~·i~.~ w~s·sub"uifr!ed to Malina L:fel(lthq11ro·~l!M2013;Jo;1t}prll.1.2; - ·· ·--·---· · 2Q·j~, Mollt\11 .Honlthcai·o roqueste4 thut w.o:.1nake nvrnerou• ohango• to·U11dn.'s p1jlor . ~utliorfaa(io•i 1·eqM8);;the l\10-".t n0t01f;10 ot' wlu~h wM th~ l'emovnl llf\ha ctistoin 1i\ie1f1'!1t¢ Mnndi11g.fe11tffi'• and ~opt ~l•~Mio,n:cqmjl.ot1•11t. •n sh'oultl be n<.>!JldSl1'1t the apo~lflb wl1\lGl~halr roeoll)tn~nc1~d tbr.Lfod1t- tllo•l?equo'btl CJ~O,(} VS.-:roquh'i;s a Qroup-.4 busii-. ..WJfl1.scnB~fovntien and·int~grated standi11g. fontu~ \0 ·p~Wmlt lhe.vaer to;indop&1de11tly .a rand. AHuoh,.tl\ese cotnP,on-antB'. Qannot be "'lel'Y fat' Lindu, we write lo ~rovld'e:.fudher jusHffoijtJon for·the re<(U0,9ted wheeJohnlr: Medlon! JuMjf!~afjQn for llcco11im·C1lcl•d Custom Power WhqelQbbll'

A-s pr.evla~sly ttcttatl. slnndlng is critib!ll for 'undo to p>'OVent 11.trthar lass of bqn·e density imd rfol1 of bon• l\·actures: d.em-oaso.musol« tone 1u1d spn•Hoilyi nia!nialn splMI 1tllgnme11t .und delay/avoict HRele1al defonn!Ues; exlend hor uppor lrunk ·10 roouo.o p1·ess1ml oi1 lntomnl ol'gans; maintoi111·a11ge ofinot!urt: h1cteasd-ff.o~lblllty.itnd pt«>v.~rit.~~tt~·uotut'll~ ~-~th~ lll)l1,knee, and unlcle')oll\mi prev.Qntpr~ssur,j. sotear Jmp1·ove"tltlim1'~· h'ilot d1·11111nge ~nd renal :l.'lu:iotlon: acldross i;us!rolt1tesmr11~ 1-asp.fi:nttiry, '!\l\tf~pwel:J\Jn~tlo(l) •nd innf!lt~ltt 91.irdt~vaao(1l~r h~Jtlr, ;fulitmna ArvR1 ~t nl., R/16WA. Po:1.l(lrm, 1m tM tf.pplt~(Jlfpn ofJT1hqd/oft<1fr:"/f1amltng J;)ovlco~, ·21 AsHisUve ·reohrioloi;y, 1111-168 ~2009)

Accoriling to llBSNA, ib<;-reccmmendcd f!•cq11e11ey·6f standing foraohl!:\!fn!J thes~ m'edlca! bon¢fris la""a$ ~t\:cn.ua the t1~er·on11.!"0ler(lle aoo.l'!hftably; ... ," U.rilikO'a aepurote,atnndei· li1nr wouleill llllprovJng boncden!if)' 11\ni1 one lonfrstandfng episode, ·wltl1 th~ . l"oconlmended wheel.obair, Linda wifl be able to. ~tnnd moi·eoften and for ~l1ortor p6riod$,'making enoti $llliltllttg op1Jortun!ty mere effective hi preventing bon1> loss and Pl'Qll\oliug ~une clenslt~. Acldillonally, th~ reoommended wheelolmlr Y?lll pl'ovfole Lindi! with xopanto\{ oppo1·tu11f(les tor "dynamic Jondlng" of the bones lt\.hcr lowot o•tromJlie.9, For example, dymunio lonrllng occiu·s tlul'lng tho fUahsllfon fibll! Sitting to atoniUhg_. lflln htdiv.ti:lual staods fn a sepo1•ale;s'tander fon one · ham·, dynmnro· 1ondi11g ooout~.onl,yonoo. f!etn h1dlvid\ld( gMU :froin s!LClng· 1.6" sturoclJ11g111.\lnof,(lua llmes·evory·doy, more dy.1ia01!0.Jcntllng 000U1:s1 with grertt bo11etlno the user'ir.qvernlJ bone henlth. · · · · ··--~-·-···-- ·

Jt ill imponnnt to e11lpl\asfa:e that.Llild.n pm'l16ipat~d llL n fl'lal of the Pel'll1obll t10wer star1der wlih sucees~iu stondihg 011d d'rivil11> tire' chair. WiU1 rtw·recommouded wheelchair; LitJda·w.HI be 11ble lu lm;!op~ndon!IY attmq 1>mltlJ1l~ limes enoh dny, withoutdsk Qf t1:nn•fer inj1try; Md 1·ouardlosa of her loonti6fi at h61he oi: in \fiecc11m1t'1llt}'. This Increased frequency of stoodi~g .will nrnxlmfze the r11ediC11I (l¢~clflls 6"f stancllng, including l1utno1 limlt~ct to, providihg com'(llete firossui-o 1<1t1er from prolonged si tl!ng; 111nh1t

----------- 32

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·sitting .y;J{l hofp. Linda malt)tain her health and woll·belnl,! and dearoMe th'.• aseoolated·~d•t•· of. her'future medical care. ........... ·-·· .. -·· ·········-·'"···· Again, it:ls OUJ' professlonSt oplnlo.n that the recommended·whcelohalt.Js me<;llcally. ne~essap1 'for L.itida and will ameliorate ·tho numerous .medlc!il compHcatlons she ftices d4e to tho s~verity Of har dls~!illlty. It Is also our opini6n thatthera ls no other it<:m of equipment ot comblnatlon of Ot\ul~ment· that can a

·Sinderaly,

'. '

Lisa Wenzel, M.D•. WV- .

33- ---·------·--------------------------------·-

000052 TAB 3 llJOH/CU Page 14 Of 61 received on 5120n0131 :33:06 PM [Pacillc Oa~lgli Time!

... ·-·-· ·~ ---· .....

WMalohaMS c.oo.te·r/Str-lilllel' Seating· Assessmen f.'Porm·--· ·· ------(t;cpjl{ome He11lth S.eri/lcei>).(7' page13.) 1.. .. •t~!ftot'·oita:~~\{·?i!f.;~!~~~~~'(~ili~: ····'!ti!; q .~" ·-!:J'.( ·'·t-·~~;~~J.;~;. • ~, '·'~~- t ....... _,. ;~ ··~!. ~11-?f~-J~t>?l~:.s ·.:~~ ·-~r w:f·'i1·1 ·~·,,, . ~!-"''¥ :. ~:,~1--~:n1:\,:·~·•.•·.~.; , ' .•!!' . i\ • . , llo'f A outrvnt.-wh~ell!halrl'-CO<>.tor/•!roll~r se~Ung •••~••m•nt,i:<>OPUd\•d by- b p~yalelen or • phys[C.f dr aoou~aUonal tti~raplet iml•t·t>e com~iet•d for puroh••• of or meJor modllldall¢n• (ln,luolng MW sbatlh~ systeli'l&) lb awheeled moblllty ~al~m. A.Quallfled·Reh.abllltatlorr Proiesslonal (QRP) mvstbo ptessnt end partlelpate In Ille seating ••••,.m•~l (ar •II Whe~l•d moblllly .sysl•fl\S and major mad1H~tf9no. P,le~Qd :attaoh:rnanur•oluf!lr·lororpi~l!Qn, do~orlptl•nJ.<0nd an itarnlOl!slti.

/

tle~fi~•.:ll•nf~ mual>I~ JqM! Llnqa ·hl!)l lne~••!!Jld tog~ln RUl:,enq LJ!':,wh1ch flU.014•Jea a~d o~... •pooma at.tl!]t,..,. ·$Ji~•llo~ Is pre¢11l'livl>Ull~<1UI !ha·i(Uf: "1111-~L6'"1 a~ter1orehd1'••l"W mUSCllla!qre-ol the olbow, wtl>t, fingers and.litp; ..,)'lolf &HhbU!derlnJernal ro~ kl\~~·•xten~~rs1 •rr! pl•ntar ri•xo11; M tnor,e,.. lb i)iuaele•llfn~ i..pi:01•n\ ID· L111R add40)or11> knee.f!alow ext$ntiorv, and for wHst ········ ··--:-· & :tlnger ffaxldn/e~lanslori, · · Detcrlbe-passfYa·mGvamenta.e'ffeoteO.by. mueClGlone; Passlv.a ·rnFJ\tements-aff!!!C:ted b.~ muacJe tQnQ lncfude.bllatefBI shoulder. fle>rlan and extension, shou!de'r_ abdUCtlon 1 external rotallel'\; and bllal&ra{ hip' abducHon and enlUa-doraiffaxlan.

.. - ----------~-~---------~·-------- ·--···-···---- 44 ·--~··--·-----·--------------------------····-·---------~-------·--

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--·---·-. - -···-- - ·-· ·-·----- --·· -- ---·-- - ... . .. __ ___ Daeollbe. reflexes prase~E._]"hrOyQh_q~_e!J !!'.!~.PY ~~!_~J1S, Linda has not demonatratad any proteclJl/e - - - -1or poetureJ fefleX.ee, ---:-·----- --- ·------- · --

' ;rrvJJk 9.QPl(ol: 0Good 0 F.alr· 0 Npn~:

\.JpP,at exlhltnltles: Q

L~~Ef!'!'J~~~; OGoo~ 0.Folr l)lJ P,oor f'.J.Nena

Qesbrl~t1-~rth9pfldlo·coodtllQD' .•n~t.ot rli,ng~.of in'otfQ)l llf)iltat\one req4l~rig'1P.Ml•I pon~lq~r~1lon (t,e., cc11\r~ot~re~,·~i!j1Ta,e·(!f @lnal co!V);tut,., e\o'.): GIVen 1~9~:of lh!ll}c ~i;mfro/i QO{j8.1n:mqsF/Je m~.d~ f9r.tt.b•.ak f!l•~:Pl'QV(dea,1S_~blo•l(nff:~"l!$.lf(~ntn~u((.~fiq{(gn,m~flt ae t~~"!l>l~o ~ pl'W~nt rotld\a11•aP culY'!furrF ~~~ani!~IY,'·lll l(f!Sf~(Qn/ng. 'J,ind,R11t'Nfgnlfll)anl/y.i!~cro~sed htp ,!lliiM Jo•r wotg/Jt·tl!rou h Bt:&, tl 0 sorlb~ ·otherphyafo~I 11mllatlons or ooocartt• (le., 1aapltotocy}: 'P.stl~n.t has ·!nipalred'integumsnlliry sensatlqn 1 respJra[ocrfUnoUon 1 neur.ogenlo bowel, ~t\d l'\Sbrclogloel,paln. .

Oa~orfba any recant· or axpeolod changes In medlcaVph\'•ical/tupcllonal sia\us: Than~ ate no ra 0eni or 0xpaoled changes Jn mBdloa1 etabJs. Pallenf has regained some muscle fun·cuan slnae the onset or her fnJury; the1efo1e her funottonal •tatu• may otranga·over.ume, ·

If sur9sfy. f;.en)lolpaled, plea.as Indicate lhe·prodedure and·&xpeetad dater .NO·SU(\i10ry_la·anUci~ ad at !hie tln>e. ·

~ --~ ---~-- 45 ------ ------------·-------~----~-----·--·---:--------·---- -·--·--··-·· -·

000064 ' ) '

@016/QOS Page 16 of 68 received on 5120/20131:33:06 PM !?acme Oa~lghl Time)

®·NOnambu(alory-. -· __ --· _Q_WJ)h.a~slatonqOot•B 0 e~¢e~t~d In Mure WJlhl~ years

.1 .1 l =~-~~1~~~',,,.""'l'JU.""'"""""""""'""""""""'""""'-""""""""""""''""".c;:.;_~~"""~ Wheel<>bair Ambulatton! I• eUent t<\talJY·de~El)JJlenl upon whaelc~alr? t8I Y•s O No If no, pie.as& e)

lncl/.,.ta the ollan~a transfer l2il Maximum eas/etanoa P~PablffQ.eoi· o·Ni1rilmiim •~•1stifr1oe Is Iha cll•o•tuba feM 0 Yes i8l No lfyas,_pl•al!O axp/atm

Feeding: • t8l Maximum aa&!slaMe 0 Minimum assl•lant;e . ·8 Jhdepanaonr M~derete asaletanO,e

O!l•orJbe·olt\er e.cHvlfl~~ j>.erfolJ)'led'Wh fo ln wheelohaJr.,Groomfng ahi:f hr,!jlen& a.otlvi~\!.~. ll~ ~re4~1~d. ~erba/ a.nd.techno11191cal O'omh1urtl0'1tlon, voldlhg, andihetapeuttc aetlvtt •• lncludl~g ROM, strengt~enlng, an~ weJg~tboarlng ac!Mtles are.all completed by Linde in the wheelo~alr.

ls-lhe homo' aoc;essitif~-le (he Wheelchalr'I !8l Yes 0 No fire ramP• ovE!lli!blo Jn lho home sett!ngJ1· Uill:Y•• 0 No CleSGrlbe (ha cllont's·edUcatidt1aVVooef/onal satt/n~: L/n~a I~ unemployed ~acoMaty to her olsabillty.

I• Iha schO"o/ aoceaolbla lo the·wheeloholr? O Yea !81 No

-~..c--------·----------------·---~--4.6_________________,___ 000065 Page 17 of 68 received on 5120110131 :33:06 PM [Paclffc Daylight Timel llJ~l7/Q56

.

- ,Ar~.tb•lo. ramp~·~v~n~~I• In.Itta Mtto.ol •~ltl.na2 GJ Y.es ~ N9 lf·cli•nt·l• l~:~clibal;'has a acMol ln~raplsrbaanJnyoNad·ln thd,as••••inen\? .D Yes 181 No· - .. ·~ ·•

N•ma ofacnoQf.theranlsU NIA N•m~ of $choo[: NIA

b;St:iib."Wh_er_e_'~lh~e-w~h-ee~lb~h-•71r-w~ll~l.b-a-a7fu-re~d7(~h-om-e-.-.n-d~~-r-s~oh-oo...,_.l)r~h-o-m-e---·----·-,

1--,---.,.------...,---,.--:-~;;-.,...,,-__,, _ _,~=-------· .. -·• ..,,_, __ _ D•••!ibe·w~y current soatlng system ls.not mooUng ·oll•nV'~ needs: -NIA

Descrlbe lhe medical nacasslly for moblltty. bas~ and seeURg, system-req~astad:• . --- - Determined vta,extenolve tnals1 the sealing aystom ollnlcelly rneommendad fbr Lfn~a .lnaludos:

Pef!1iO.blle C6QQ VS· Stend01r pbwor mobility base, requ~•d to enable f\lnctlons of.the Whe•lohair ••a whole arid lhu$:·anow ~Inda to mano~~•r Within her homo Independently In a as(!; end reliable manner. i'i"t.$ealWldlh, ~:!~.~~•l depth •.bt~rdlng lo ciln!di>l maa~urartiehl•Uated below.. ~-n•t remoia.joyatiok, color djsplay with mono·Jao~s (mounted on the left, as Lind'~ has ae!lv~ "•e·af these fingers.using.her DIP joints) lo allow Linda to qpereta·lhe wheelohalr-ln ell dltootlons·~nd a~gage the power1 Ult1 reol!ne, and stantlln~ fe:ittvres.

R"1el rettaotabla )oyetlck mount aUMJiea·U1e)oysfti:!(IO ttta vlheeloh~it.foi o~erallon. . . ~partl!El~Jir.contrOI '!11th h~me.$S t

... -. . ~, ~..,.~,---·-·----------------,,,,,,,.,,,~Ji'ilo"'··"'Diii=01"'91"'"·'"'11"'1R•"'•'"'•"""'"'i,,,,_ .,,,. .1?n11...

_p . ·-···--·····-·--·--__: __· ·-.~--------·----------......:..1..7_____:._ __ __: _____ ·------------·-·---

000066 \l!OlS/OSS Page !8 or 68 received on 5110/20131:33:05 PM ~aclflc oa~lght Time! ·~·

o·a~·~ar tov.s~ df:!sks, 'and of her work .surfaces durfn9 funcffonartaeks.

Power lilt ond·reollpe (eaturee snabl~ tar to.p~rr~rm !l•f·OWO' praoa4r~ relief wl1h. p;~~~r lr~qu9ncy-:-.,;a-­ ~"r~ilon to p/ei/"'1t prolong~dwelg~t beall/'lll ititqugh l•i:hlals.a)'td pre.vent •.kin btaak~awh.

Multl-Sea1.control FunotloA.'Klhwlth Toggle Swltohea:..raqulrad wm1 mars Uisn.ona.powar eaaf fUnotlon. Llhda·i• aU!e to use 11er bll>o lo opereto the fqgg)e swllehee !Or pdweffuncttone.

611~/hg oackresJ kit..with lil/~ln9 ba'OJ

Corpue·l\rmrests • 4"~16" \'iftfl.bliateral·elb9w blocks end rlghtoatsr arrnre«t·stjpp'cm. Tira allioW block• keept1qth ~lboW• from ta!Ong off Qr.catchlng'Qn the. armre•l~pt>StarlQrly. T~a'l'fl(M pUt(lr. •r

Power Elevating, Artlqufaling, Gant~r-maunH09t platlorm·(1.pfeqe): required tor lrana(ars

Knee blocks: required rot use·wllh standing feature for safely.

Standard, oon·p.aO:dad, medlumj pvsh-bvtlon hi!' po~IUorong b~l~.to ~1a//1taln l11ps In Wliaalohal~~aat sa wsu ·~pr.event faillng/slWtng.ou sfwhe~lobal~ 6" x 6" hip gulqp~.V"lth rl\l1Jo'1P.PI• h~rdwar~: n!i06~a~ry to-ko•? hlP•·•Pd Jower·e>c.tre'm!Ues ln·&O,!Jtrel allgoment In 111mn~ and sta"rldlnl)', .

AdNstabfo che~t bar (10' wide): oaoe'ssary for u•o wllh s!andlng fl)atwo lo vre~ont Ratient from fiilllng forward.

BodypofntMonoflex CMsl Strap (medium):' recommended sa a safety Faatura during standing, and d\Jrt~g transpor,tallon when riding In tM Whoelchelr.

i;ta~lth oomrort:Plus helli;Jrast (10' Wido) with ramo.vable hardware to maintain oer1loal.aflgnment end pi'evant-.lrtJUry In t!lr during pressure rellera.

Pswer •eat elevator: required when vslng standing. featu,,., Power seat ala.valor will alad dect~~se oaraglvor "uroen when assisting the patient with late rid l1a~slera fly adj usu nu tHa' •••I h~illlil ta mak~ tho transfor.cio.'!mhll!. TJ\a aeat.aleva!Qr·aflows for Linda to .accoea Items In upper oablhals ~nd. ,9auntertop$ .·. lhafshe would otherwise ba·.unable to reaoh. l='atlent-ma:y also use e:eat elavator·lo lmptavs .. I lndependenoa with ·and fUnot/opal reach aotlvltles es her neuro1ogloal funotJon continues to Improve. l

Sl~ndln!l fB!ltute: THi>.atand1ng·teature.allOW• tlmfa to ~aarwelghi through s~i::a.as b.eca'asa1¥·tndlng feetvr•'~l~o'!llOWs hel MPl3••·16'.lt

16" Wide, 16" tall Matrtx ~lite deep beokreat provides stable postur~! eupporl I~ prevent rpfatlbo.ot the trunK •nd ourvature·of th.• eptne. The height ofjhe backrsst'gJv~a naa~supp9rt throughovt the·fenglh

.~ ·-·--···---·----·--·__· ________·_··~------·---·_4_8~~--~---

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-------1ntt.inil_a'a thorill<, an~:tM.d•pth of.U)I~ model Rt•~•Dts c

1S'"X 2f)" Invacare Slab]lle, cushion.provide~ adequ~t~ femoral ~upport to pr$v<111l abdu0Uon oMhe lhl9hs' In altH11g .as wsll a~ lscjilaf P.•~lt/Qnlng In, IM (

DascMba fhe sqvi~roant ra~uesl.~cil Delarmloaij"vJ~ •*leiiiiive f(lals, ·lhe·a.-all~.9 •yale1J1.oliri1caQ~- -- r'IOommeocl~d lor. llnble hardw•t• P.OW~t·.aat eleV~W . 1'S"Wl4~. 16' tall Maitl~ .el1t.e1d!f~~ ·~~pk(e'at 17" x.ze" lnvscar~ ·stablttta Oll•~fon

Qesoribo·Jha groWlji pbtontlal or ~qUlil\tla~traqu~at~d In hUtTiber pf yeero: LJ~da has'l(Jet ~P.PfOXlmall>ly q '. p

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000068 Page 20 or 68 received on 5120120131:33:06 PM tpaclflc Daylight Time! r• . .. - -· -·

- - - - - - - - - · TIRR Mernorlal+lem'lenn··-· - - - ··

baserlba•lh1"'uad\bal·ne.:Sdlfy fot power VS, ri!a~Ual Wheetohalr! (Ju•fl!Y any ao.,;ssollantl1111)' an

I• ••tr prop~lslort passlbla·but con!l'acy to·l,rehtmanf l•Ulmen1 D v... 121 No II )'OS, ple1'i;e.exple/n:

Howwltrthe,poweowhoelohalr bO'opera°'d (han

tf~s tfi:3..£1!'!!1!:...~~y~eted ~llh the proposed drive·oontrO!s1 Yea "'--. ~~=- Ooes tliij c)lent have a~y oclldlUon that Will nilcesgJt~la possible change ln.aoces6 or ~,rlva confrol~w\thin tho n~xt·liVe ye 0rs.? No

la tfla·ol\~nl physically and me11tai1Y. capable cf op•r>1tl/l~ a ~owerwhaolehialr s~lely end WIUiY~epetlt to olh~rs? 181 Y.e 0 No I.• tho oaregfve1 capable 'Of caring !Qr a power whe'elcheilr.and un'dats)andlnl) haw It operates?• i8l Yes 0No · Hew w1111ra1111ng·fpr lh•'Jl<\ll!ers11u1p1Mnt be>'!il~n1~11ahGd? :Untje·h·a~ t>'eWt trl2illn~.aj)UW.E!( wnoalGhalr With ~ln111ar dh'tfen~Jon·~n\1 ~ohtrol unlt~~urlnS M~ ~dmieOlon el 1Ne liO•l>itill. She ttas tlom6Mtiated·lh• ability lo safely oper.ate the eoaUng eystom In et

.,. .i

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-------. - ..

.Ji'f!'> 1: 31..B' 1'op Of Mad !tr bott

8: 18" Shoulderwlclth

I ,. e: f1 .5' Arm pit to arm pit iO; ~-·-+H-"'l"-"w"'ldc::.lh:.__ _ _ _--1 11: 18.6' Olstanoe to bot!ci'n.df left leg (poplftaa/.lo heal) Ols~Gfi to bottom of J1ght I~ :oioplltaa/'ts he~/)

OflP Blgnetu e: - Date: ~

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000070 IOIO z Z! 0 i i Page 22 of68 rec~ved on 51iOl20131:33:06 PM ~acl~ Daylight Time!

... -···--·---··-

. p1\9slclan1T11araplses !ll[a: Oocup.~Uonlil · ·- · Dato: , ··· 1~:/· ·~ Tnorn IH · 1 .,, PhyslolanlT.baniplsl'a talephono hu;;;;;;n 71a}79Z - 7~77 ---- PhyslJllan·l.i'haraplat •111proyor (naroa): l'hyelolan/TMraplst'6 addteae {work or e111ployor1addree!): TIRR Memorial Herro~nn 1333 Mour•und AVo, Hous!M, 'f.)( 77030

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000071 TAB 4 (JI03l/06S Page 3f or 68 received on 5120/20131 :33:06 PM !Pacific Oa~lght lime]

. _ ·- __ __ AsJ/stlv11 Tsdi}\oJoW.-, 21: 161 .. 168, 2009 C'opyright ¢12009 il~5NA . 1ss1-1: l640.Q..1J5 prlnv1g49.361"--onl1t111 - - --.-----·001:- to. 1ali&1nitoo4·:!oso311saii

RESNA Position on the Ap·plication of Wheelchair Standing Devices Jullanh;t.Atva; MS, ~TP, 1 , Ginny Paileg, PT/ Mlcilalfe All-SlJlACT Thi! do®f)lent, ~pprqved by:· the R•hobllltarion ·Eng!neorfog & Longe, OTR.-ABDA. ATP,' A"iitive 're!!lmology Soci fro in ATP~ 4 Marl:( S~hmia;ljr, flhO, ' the lltcta~. Npporting tlii> U$<·ofwh•oldµ!r •tllntfor<; OTR/L~ ATP/"Btad bldanno, MO/Mike !iobloec·,:omi, · KE!"i:WORQS PO'lie.t features, reltribllltatloti, stlindlng, wheeh:halr ABDA. ATP,' am! ll>"ron Rosen, P.i, MPT, ATP* 1nsPort LLrZ, Ket'lnewl.;k. Washington• 21ndepilrldgnt.Consultant, INTRODUCTION Mal}'lruid !lch!ldreti't Hospital of oenvet, The·purposc·oHhls :uticlo Ir fo fh•r~ lypfcal ciinka! nppllc11tioft1 ns W•ll ii> Denver, C-o!or~do provide rJ.vide.nce from d\q li~ro.turis supportlng th~ appUca'tiqq bfwb·~ctchalt 4Mount Sinai Mospltal, .standing P,c:yiCes to. !lSSls~ ptns:P.tlonc.rt in.di:=cl.rlon mnlclng rind justJ.Eioa1ion.. [t _ New York, New York is not i11tended to replae

Shtndlng bi llI1 cll"cc:tive.wa.y Co counterbalance Iru!ny oft:hc ncgatlvq affucts of •s~ JOs•ph's Children's Hospital, Tampa, Florid• constunt: sitting (Dunn ct al., 1998; Un~·etal.1 2001), Stn{lders fntcgr1\tt::d. hlto wli ..kh•lr hases erthnnce liie bcrrefltlal cltOi;tt oritntidlhg-slne~ they olloi. for more frt;quent, randoni, Jl'ld independent perforJnancc of'·sbUlding tlian among parsona who Use! ata:ndlng aovjce.! outside of il.whcdchair b~se. I.ntcgrtttlon Of this feature into th.e wheelchair base 1\lto vlt»I etg•n cap•olty ' Reduce the oocnlrretni;.i:: ofuri11iu:y tmct in.fcctionf (UTis) Atidtcn «itrot"andence to J.ofi;sf\nn " Mnintl'lJn bone mlnei:o.1 dendly AN4, MS, R.O!kOIJI~ 11.G, 1/1, l!Othip~ft o Improve cfrculatlon 1f22. Hun~;:r)', ~-mall: J11rv1'9Ulttit.t:om "' Tm.prove po.!i;iva r~ngc of tnotion 101

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000080 .JJ \ll032/0oS Page 32 of 68 recelled on 1120/20131:33:06 PM ~aclftc Oa~lghl Time!

·····-··-- ---- ... ,,. Reduc~· ·· ··--· ···--·---;.·Red~iti~• -----•·-81thanco psycliologloal we·t1-bcing- ···· ·· ·· - ·· such nt wh~n .•hoppinr for grocod/,Cllob1il)•likJo peifeQn at.anding from one1s-wheolohttir-1lho 'ftlln.ii'rli?.¢s _ ·- . ·------ tra.ntfer.s.- thiircby .enhancing: n~.f,fty, cons1qVfn-g.ener-gy 1 Sp·eetnl ptt!cnutioO.$ nHt.St. be exie:rcl$ad when uti)lz4ii; ~nd reduciri~ dcpen.d4:rtcy. Ro·s-eJu:ch suggi:ists. ~hi\t \n S:tandcts is1 order. to :i.vold the risk of. infudeo such. as ·l\i:fditlon to·¢::

Definltlons. Passive Ranga of Motion, A &tandlng 6:nture jnkgrnt'1!d in.to\\ whc:c(clltlir bd;e Contractun;i$ alloWJ the user to crbtnin a strtndltig Posl~on. without Standing oxtcntls the hip.and knee Jolnt'to·provkla tha n~ed tO tl'a.risfer ttO.u1 the Whp~it1i1lit. A in~ohanicd poiltion nnd back• 19.9~). Mony pcop)c in whcolohal" h•v• Hmit•tlld with the wheel· •ltting; througft gradu•I anglo cn~ngos fr6111 • faylnB ,hail' b~;•·nllow. thw:n to perform this l111part;t;\t nctlYitY position, or a cornbinntiori l)f t11e~o._pcsltlo11,s. Mo.&t 6tt thelt own ·And with l\Jghe~ frequ~ncy, S~anding, whodchllir •landers ·•llow for full or portlal me11doJ\ tiowever, ~hpuld not be caniidarad l\.'i " .wbs·iitute fbr of th~ hiil and icneo jo~1tl nud tull up rig lit or portially therapy. tllttJ positions. Wheelchair sbmdcts .,. •vailable 011 manual or power wboclchoir bnm. Wb.colchlllt stand· ing·.dtviccit p;dclress tha· mod.lo~l :tlld fquctionAI needs Vital Organ Capacity described ht the sections to follow. · Dudng standing,. the pelvis tends to M!lllfn:c A. ntoro ;lntO:rfor tllt or nCutral,p~sitipn,_ 11.lluwlng: for.;in incre:uc Functiliinal Rea·ch and Access to ADLs lrt lumbnt lorddris as comp111'e.P. ta sitling. '!his in htt1t helps cstabll•.h • bqttor a11gi1mcnt oF the' wine ~,,,;1 Stnading addt 11. .dg:riifioan~ wiounc _of. vertical extend tho uppo.r truhk, Bxtemion of tho upper tmnk ·ncc<;:ss. Sln.cc the li'~th1tt Jurfi\ce moves llil"o.J! .vertical results in reduced pressure!! on t,h.e j11renia[ org:o.i-is~· tha:rdby . po•ltion, typkally the atno\1nt of addition.I -v.:peri'efice in1provc'd lung. (uncfiou. An ·iittc$rnted whcc(chnir stander system capacity when st.anding oftcll. Studies: .hnvc qhown 11Uows: for moving about while in n .standing 1;osition, th.at those who stnrid frequently in ·stnnding power ttnd standing cnn bcco1ne lln iniegni.l and func.1ional whi:.clchoirs have l~sser or deln7cd o~nri:nt:e ofrc$• prtrt of the d11y 11nd the wcr_ci\n·pcl'fOnn \l vllrid~ of pir~tOry complication$ lll1d improved resptrotory ADLs while !11th• stmding.position, combining func· vol~me (Eng et al., ZOO!). StAnding aon oho help tlonal ond inc:dic:al benefits. A sttt11ding podtinn ~n reduce congestion and cou,e-f1ing (Stuinsby a; Thon1ton 1 b~ a~suJncd as needed, both for indoor nnd outdo·or 199!1), J. Arva et 111.

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- ·· · -- ---_. Gt:11lrfJl1u1stimJ ptablems,• Stttrtdfng wha~lchain· u1:1eu · BM)) leveI11 will continua: to decrcas· le, mCJ

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'.Mcchruii(lttl weigh' /adtilng: Living bon·ee co.nJt'i\htly ....... !OaQ.ing) (Fro~t. 1990), However, long-term routi1)\l 1tdapt tharruelvc~ to· the tn.echo11.lcal "ibrc:el npplied londing Is. frnporlaitl! in maint~iu.iua~ bone den~ity; - - - - - - - t o thom, ~nd thcicsti;ucturd( dltootly..llnhd to their··· · · -And-althout

ttinlly or fully JUPP.ort tho body'r weight l?8SJ Dtlnkwotor, 1994), Wlth •rnndUa intCJ!1'l't•d ogse, th< useds ttot dcpondanto\1 bCltdni activity thorefur~ Jnvolvi1 some impact or clraumst:tncas (such as carcg\vc< 'VRli•bttity) ro. con- lQrc~ being 11'i!U5utllted I<> tho skeleton during woight tinue standing-, Cousoqu~tly, m~inton•ncc of a be.iring. Stmding pt0vide.s me rcducod or limited woight ~ei!rlng. • Dy~dmic /a#i"3: l'urther studier clarify th.t stnnding Clrculatlon 'ho'11d be dyn•mlc Qiighor multltu'de •nd vorlcd Usett have Rl!lo axpe:r.i•E!nccd imprOV"cment in lqwe1r magnitude) in order to fully prmdor (l\)ig o~ al., 2001). Ono benefit i• b lo,. effieict\t th"1\ dynamic [o~ding Jn preyentlon reduc~ swelling in the lcg.t end r~ct. of BMP lo" (Frltton et al., 20001 Lanyon, 1986: l.1tnyon & Rubin. 1984: McLeod et tll 1 1"9.88; Rubin &; L.;nyon, 1984). A .recent rtudy ot chJldrcn with disrt:bling uonditiana: fuund tha.t o: 6-1no11th stnnd.ing program wlth a statiomuy staifder lrilf re•ulted in Whccfchair staU:dt:rr al~o ;ld in rtduoPon of eX"Ce.R$ UMD reduction {of 6.3%), while utlllzlng'vlbroring 111uscle tonei re.Se1uch indk~t.es th1u muscle Stretch. plat!::I underneath the s:t"i1.11ders 11ctunUy h1cr1Ji1.setJ combined with weight loadh1g redUc.e.s muscle ·tone B!Y{P (by ll.9lfo) in tho subjects (Ward ct :11., 2004). more than stretch~ alone (32% vs. 17%) (Odeen & Thi.s i& of uttno$"t impol'mnc:a rc:gardirig standing °K'llUts!bri, 1281). Some llSera experience .tone reduc- wltcclch.a.irs1 ,thice they offer dynamic lotdln.g in a. tion ·in their upper extremities due to better skalc.tal v;:u:ie~ of ways. Wh.en udns: a mobil(I wheelchair alignml!Ilt in Cl 4ts.nding poritf.on. 'fhi!J _may trnu~lara bMtJ during ~t11n~ingo, vibratlon occu{S due to ·the !nto improved s~1;ch o.11d b~tt:cr hru1d and ann func- 1novement of the whe.Jchair opplying dynamic tion to perform ADLs. Tone rcductlon can improve loRd$ to tb.e bQ11es ot'lha lower extremltio~. In addt.. comfurc, mlnitn.lzc frutb.er rnngc of.1notlon loss:~~. . tion; sm.all obs:tttdcs (~g. 1 carpet e.dges,'doorthr~h· .. hnproV~ l'uo.ction~ a~d ~onscr.ve ~ne.rgy• . olds, tilo edge,s) prov'id< dynllmia inp\JI when the user drlvc! over tham. Standers integrated with a wheelchair base also allow for fr~quant log et •l., 2001). 'l11is helpv with lt>nsfort, c;ccrcUa to be. elfective1 tbe rnech~nical s.trt:sR placet! can aid ln better $l~¢p, redQt:c.'i fatigue nnd paih, and · 011 the bone 1nu~t cxcood the level to which tl)c hnprovas posit:fonlng in tha whaol.chair. Stnnd.ia~ hns nn bot1

• i

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000083 @035/0SS

Pj-e~s4re Sores Additional Benefits When fully Slilttdid.g, pteutiro fa compli;!:tdy ft.)icv~d · Additloti.al benefits ofutilizi11g: ;:in inregra.tcd whc:d- off the U.:htill ·rnbctO~ltiC:11 (rfi). HCrWCier;· WJleti tJJiW.g----~-bOli irilildliigsys~d.liii.ciucreD·ut·Are·riot limited· ta:·. ot rc.l'.!Ui:iiJJg... the~Js.only.parHnl rc.dfatdbuti011 ofpre.s.. --·- -···-· - . -·· . -·-----·--·- . ··- . . . .. ____ _ ------:,:::~=-urtdCme1Hh the 1Tt (Aissnoui et 11.I., 2001;· Jiobson, o flatig!.I~ is 1cducad due to the benefit! .mentioned ---····---·· 1992). I?reSSur~ ulcers are the.prlm"Rry camplic:atioh for ·earlier. tb!Jrcby prolonging tolerance hr tcrnu -of p~opfa- with SCls· and m11ny other 11dults who .sU in .stayh1g in the whcdchnlr for lot1gcr p.eriad$ of tinl.e. whaelchitlu .aU dfly long (McIttcd fQ transfet in, rnd o(lt of the .wlml\':h•lr m)l Improving the RbUity to J'dllge< ind'opendcntly atid peiform ADLs. Skeletal Deformities • Back pain 1U1d rl$ their alert11"s :111d/or their upper the femur uaunlly ends lip better scntcd.ln the acetabu- cxtr~mity function. lum. which ·ix imf)Orf"ant cspcdalfy for children to pro· • Mnny child~ who ullc- n1cblllty aqulpme.nt through- m.Qte healthy skelet.i:l ~lig,1tinl!nt us well

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Co.ntraindkations lo"?"''"., often" the""'' con tolerate oomfort•bJY·-- .... fri ipfte..Ofthe rlumCi"6u#·h¢1tcflt:J;n1:rudingwbeeJ------~?-~.~.:1?'':.asc ~~ he~-~e~~~· Stao~an l11~~r~t~~~~~!:> · -------•ch.nir..rnight bo cc;intralndlcnted_w_icli.Qut appr be lhu· ~hha~lng. 1ndependcnc., 1111d prod,iJ.ctivit~ maintnin· itod mecl1"nionlly· orltti11g •oropr.iati! 11\lpport fot &t;t.. CASE l!'XAMPLES bility nnd funt;tio1i,. so sp<1:'4fo.l accommodntioni n1ay hl\ve to be }UovJded for people with significant J, 0. ;., n 19-Y«tr•old male with spastic atheroid dcfo:rn,iti¢5!, C$"pcclally it' those defo.ru1ltll!~ ri.ra not quadtlploglc cerebral palsy, H. h;u been drlvlng n flexible. s.kelct•l •lig~mcl1 t •hould bo c enh.il-t1C~ independenc:.e::, and to reduce his .stnndlng fur o. ~~11i!.ica_i'lt amount of time (s:cb.i;dulcs vuy _by perso1' and ·circumstnnccs)~ rt is n<*uaty to mother's bac.kpitln, which ih~ developad due to fre ..· o{;ta-ln a f>b.)'&tcian1a apptov:J t1nc::i t-Q.,t 11. 4llu1urcd ~eatlug sys- atrcct. Following co.refill asscurnc11t and an extc:ndvc tem$ doe to shl!nr. · 'Uinl of a st11oder1 lie·Wll.$ p.i:D'Vide.d wi'th I\ po~r wh~ol~ i;;hait ~quipped 'vitb a pl\s&ive sbtudar as well a11 tilt In '$:pt1cll, tecliJting backto~t, and elevn.t1ng.lcgre$ts. A-t il frequency of Standing 6..montJi. fa,llow·up assessm.crtt, his teport

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000085 1

;il.~o nllowt'd him to hnve ilnproved bed mobjJi(y so llohamon, R. W. (IQ9.~). illl tohlt nancltny for 1eduti11!J J1u1t1d1y ilttr · --·· thot l1!ll c9llld get 'a full i~ight 1 s sleep, MO(COYdr, the.re . ~~/~~1';t ~Jvrt.. .ArrJifva$nfPltydC11/MtJdlellJr.:S:Rcltohll(llll/1Jn~1-1, 2 -------.llW[!!;_a.> no noted cde1na ht hi.!ii.l'lWe.i'..!}-Xl:(croitie$'~and...hc- aonnre~.S.L'1~9it}-h~O$tl!:d~hdno'll0ak:ol'dlas1T~)kiP.vhlls:hll1g. - reported far fcw~r bowei And bJadd~ t.t.ccidcnts td the OAIJ!::y, G,.; StotRe, Ku Et\Sill'\I, A, S/a1opqlgky, !-~'lder t. ~ .• & S.lrgii, ~:I -------- I ·. - ' . ·-- ·--(:l-981!J,:..Wel9ht·b.e<1rfno cxor~h&·tta.ln.lng- iln!f·h.lli'Lb.fr b9ht miner al o nt wH~ro he .,Vt1s c.Om.fb.ttahle g:ohig out Ul the com.~ ronlenf ,In postmenop11usal \~m~(I'. Af}l1;1h at tnCtfNf Mcd/'1/ia, .n\unily on n weekly b:t~h. He demoiufrl\tUi.1 il'riprovcd 108, 8~4-s'zs; · '(' '· ·d •-- ·d'ffi ..r DMrrld:, J:, WtJo@.ri, G., !ft '5ll(:i(t1 ~. (f~). fffed$ of ln\fllQfxliza1f0J1 ab ~ Jty to nmcw an cnrry out ta.sK.:t ar. J erent SUrrl\ce \l?¢!1 v~rk,i.~ rnmb.Qlk and p!lydploWc fU(l(;tlOnj o/ noumd fl\Oo, .hm~bt,, Wl\C observad to be able ta slt- in.ore Uprl~ht . AJ.11ei{'3nJownMofM1dklTJo, 4,"3, with. less kypha.rl.s, artd demolistrat~d imprOV!!d affect. OOMJ.dsoJ\ c. L, Hl.fl*Y!.s. h.,;vO£Jd, I. M,. Hl!l.tttJcc, R. s.. S'1~B. 1. H.• & Mr. D. •1.:s a J6 ta11 · \n lils fo,:,.,,,, pl•n• Th' led to d sJ•..~if:ican~ dueronse. {SATMU)-Rer(.t1~g Wolff's law: TM bone·mix:tellog p1t1b!a1r1. 17iQ l\"f a "'' '' ~ ~ Amrofl'!k4/Re«1td1 226, 403"""41.3 iu cornph1.in.ti of sh.ouldc.r po.irt 11.nd imp.roved upper Goomaor&.: s.•. Van Laott, M., De ·NIM.I, f", & burman, J, M. {1~). extren.\Jt-ll'fun Clion, Bonis mineral 51111.11& fn p.11\lpiook 1laVt11ts wflo do.or tJo nt;it pqrlurrn 1 sU11dr~ Ostr:tJporos/$/nr«tMUo1uJ,.tJ, ta&~t'41. HanQartllu, 1. U: {1'9:9!il. onaoporo~s t;hl1f to d'rsuil!. /'liydW Mrdl!ii11~ and Reh,J.,/Jirc1.lf"" r:611Ja of North Amfflca,.. 6, 57g...594 ACKNOWLEDGMEN'rS HobSOOi D. A (19.112). Cornpva1N• 41ff~ of p~1Wt on prenure 1t1d f!1e11r " tht bcdy'fo~l lllt.offacs. Joum\ll of kMrbl/Jc111fon. /lesearrh This •ttklo was dev.eloped tnrough RBSNA'r Spe· ;indDe~t, ~", .SB, 308..J 14. flit/on. 6S,.S37-541. M~rtin, A. P.. & Hovston., c. s. (19an. OsraoporOJls, caldum nndphi,isl- l}t..iQ:., E. {i. (JSS1). No1,opor11tlvt trt:1irMnt qf o~t1tog11nesi:s. lmpu(ll.d~: ciJI acrMly. Csnad/4n Medlt41 A1t~at1M Joum~. /16, SS7-S$1,}, OrlhoUt. lll'ld l'tlObfflly mam1Qtrot-l'lt. a1111c,,1 Orthop~d/CJ Q; R11latMI Mardn, A 0,, & MtCutkich, R. (), (1981), Bone lf(,flarn!cs: .Hrim. Sin.Jin Remrrh, 1S9, If 1-122. and fracrurl!>. /(J(Jht11J of Spr::r/it .StftJ11m-t, !i, 155-63,

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--··-· __ M:i?l!u, ll. e., &. l/v>hvdon, Cj, D. (19$3). lminobH1211don ahd bone. C;r/ch, ___Thom~•. C•. {{., A9onl, S, It,, DWo<'.lfe,· H, ·A.. flfer-MoS!tr.: ·t. M.; ·· fled 11.uue lllterna1(011al, 35, 26S-:tG7. LOO:tturt, T. t., ·& tod:h:it~ t, A. (2000}. Fi;om tfoitr Ii~.&.!: F.1f111;1" of--- -- -:-----·-- - · ·· McK!rll11y, W. o., Jn(~fot't, A. B., Cilrdell<\F, o. 0. 1 !Ii D11VJYO, M. I, (1999), dyr.at'1'4:~1ght baar'~ of\ !aJ.l!f ~l!mity b?iie'trJili'~I d,..n.sityl/l·d1R• -------tot'1·tom,m«11u_l)'Stems IU\Jl.lyslt. Arch/yes of Physki/ MKl1"'ne & Trud~ G,, &;lllltfloH, f-4. !<. (2000). Conlf.!ctu-91 soca~ tqJmncliiUtt: -------,fleh.&b/Jlt'arlon, 80, '1402-1410. _ 13.IM tintHt.1J9i1 :irtt(l).llr ~- rnygyiari.k> ~pefiment.11L lon

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000087 TAB 5 Aug 27 13 04:37p Amy Morgan 859(.j:J877 p.1 .•

AFFJDA YIT OF AMY MORGAN, PT, ATP

STATEOFKENTUCKY § COUNTY OF BOONE §

BEFORE ME. the WJdersigned authority, -0n rlJis day perS-Onally appeared Amy Morgan,

who being first duly sworn, states the following:

I. My name is Amy Morgan and the facts to which I attest herein are from my personal knowledge and I am competent to testify as to same.

2. The following statements are based upon my experience in the field of physical therapy and· rehabilitation technology. I am a Licensed and Certified Physical Therapist and a certified Assistive Technology Professional (ATP).

3. I am employed by Permobil, Inc., a manufacturer of complex rehabilitation power wheelchairs for over 45 years. I am the National Clinical Education Manager and Standing Specialist with Pennobil and am responsible for provicling education and training in regards to power mobility lUld assistive technology, providing clinical feedback to the design team for product features, and assisting lhe rehab team with a clinical decision making framework to ensure the most appropriate and cost-effective option is being recommended. (Resume, Attachment A)

4. I am very familiar with the Pennobil CSOO VS wheelchair which enables the user to ind~pendently stand at any tjme and m any location. This wheelchair is unique because the multi-positioning power standing system allows. the user's body to be extended before gravity and weight-bearing begin. This is extremely important for users as it allows a customized standing sequence, which will accommodate for any postural control or orthosra1ic hypotension issues as well as ensure appropriate postural alignment and reduce the risk of shearing and sliding which can compromise skin integrity.

5. The multi-positional standing system (E2301) of the CS 00 VS must include the following power seat functions for the mechanical operation of this wheelchair:

(a) Tilt and recline (E 1007) (b) Center mount articulating elevating legrests (KO 108) (c) Stand and drive legrest assembly (KOlO&) (d) Seat elevation (E2300)

The tilt/recline and elevating legrests allow the user to fully extend their body in preparation for standing. The stand and drive legrest assembly provides the anterior stability required for safety and balance of the chair while standing, and also allows the chair to move in the standing position. The adjustable seat height ensures stability of the chair by allowing the stand and drive caster whee ls to be appropriately in

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contact with the grounel - creating this anterior stability for safety. The Permobil C500 VS cannot be ordered without the power seat fimctions. listed above and must also include the multiple seat function control kit as it utilizes multiple power seat functions. (E2311)

6. The medical benefits of standing for individuals with spinal cord injuries is well ·documented. In 2009, the Rehabilitation Society of North America (RESNA) published a peer-reviewed article entitled RESNA Position on the Application of W11eelchair Standing Devices, Assistive Technology 21 :3,161-168 (Attachment B)

7. Ibis article reviews the scientific and clinical evidence regarding the medical, functional, and psychosocial benefits of wheelchair standing devices and concludes that this type of wheelchair is medically necessruy for certain individuals to maintain vital organ capacity, improve circulation and passive range of motion, reduce the occurrence of urinary tract infections, avoid Joss of bone mineral density, decrease abnormal muscle tone and spasticity, prevent the occurrence of skeletal deformities and reduce the occurrence of pressure sores.

8. As noted in this report, "standing is an effective way to counterbalance many of tbe negative effects of constant sitting" The medical benefits of standing areachieved by;

• Allowing the wheelchair user to extend' his or her hip and knee join1s in order to decrease the development of contractures in the lower extremities;

• Providing better alignment of the spine and extension of the upper trunk, resulting in reduced pressure on the wheelchair user's internal orgatls, and avoiding the onset of respiratory c.,-mnplications often experienced by prolonged sitting in a wheelchair.

• Allowing a wheelchair user to more completely empty his or her bladder, thus decreasing the onset of hypercalcemia and urinary tract and kidney infections.

• Reducing the occurrence of chronic constipation, which can lead to bowel obstruction.

• Addressing the loss of bone mineral density, which causes osteoporosis and an increased risk of :fractures.

• Improving blood circulation in the lower extremities and reducing swelling in the lower extremities.

• Aiding In the reduction of excess muscle tone and muscle sprurucity to reduce pain, improve comfort and function, and minimize loss in range of motion.

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000294 l\ug 2713 04:38p Amy Morgan ) 85!'":}60877 p.3 .; ~__...~

\ I • Providing complete pressure relief on the isclrial tuberosities, which can decrease the occurrence of pressure ulcers.

9. A wheelchair with integrated stander enables the user to independently move from a silting position to standing through gradual angle changes and allows him or her to obtain full upright or partially tilted positions to address the many adverse secondary medical complications that result from prolonged sitting.

10. The standing feature of the Permobil C500 can be used while the wheelchair ig stationary or while moving at low speeds. It provides numerous opportunities for dynamic loading of the lower extremities and is more effective in reducing the risk of loss of bone mineral density (BMD) as well as promoting improvement in BlvID. As stated in the RESNA report, "integrated standers allow for standing nearly any time for any length of time, and therefore weight loading is more likely to be of random distribution, which appears to be superior in BMD loss prevention."

11. Separate standers do not provide dynamic loading and are less effective in reducing · the risk of bone loss than wheelchairs with integrated standing features. For some .individuals, use of a separate stander requires one or more caregivers to assist with transferring the individual into the standing device. As a result, the wheelchair user's ability to stand is limited by the availability of assistance to transfer him or her into the equipment. In contrast, independent standing from one's own wheelchair decreases dependency on others, minimizes the risk of transfer injuries, and increases the opportunities for standing in multiple locations throughout the day, which has been shown to be more dfective for physiological function (ei.:. BMD, Bowel/Bladder function/Gastrointestinal motility, Range of Motion/Spasticity management/Cardio-Respiratory function/etc.)

SUBSCRIBED AND SWORN TO before me, the lUldersigned authority, on the 8-"1 day

of August, 2013. ,--.

~()~ <§,' 6 1-J'/l. Q NPublic .JESSICA LUCAS Notary Public, Kentucey State At Large My commission EXpires February 13, io1E> Nolaf'/ IDff 460283

17 P-16 000295 TAB 6 ) /

BCM B;iylor O:illegcGf.Mc:d!cioe

LlSA R. WENZEL, M.D. Auistant Pro!c:uor SplneJ Cord. llljury Proif&lll Physic:a.J MedlcitJc A Rehabilitation

Date: September 26, 2013 Pt: Linda Puglisi DOB: ?5!??"221

LETTER OF MEDICAL NECESSITY

To Whom It May Concern:

My name Ls Dr. Lisa Wenzel I am an assistant professor of Physical Medicine .and Rehabilitation at Baylor College of Medicine and a splna! cord injury jlttending at TIRR Memorial Hermann Hospital I am also a member of the American Academy of Physical Medicine and Rehabilitation and the American Spinal Cord Injury Association.

In my position at TIRR Memorial Hermann Hospital, I am responsible for both the inpatient and outpatient care of individuals with spinal cord injuries, including management of such conditions as neurogenic bowel and bladder, pressure ulcera, spasticity, and neuropathic pain.

Ia. February 2013, I was the attending physician for Linda at TIRR Memorial Hermann Hospital During thi.s inpatient stay, Linda underwent a comprehensive evaluation for a power wheelchair. As a res:ult of this evaluation, we recommended a custom power wheelchair with an integrated standing feature for Linda. l provided the required attestation of medical necessity of the recommended power wheelchair on a form provided by Texas Medicaid.

I also provided additional medical support for the recommended wheelchair on May 9, 2013, in an earlier Letter of Medical Necessity. This letter explains the numerous secondary medical conditions Linda's faces due to her spinal cord injury and how these medical conditions can be managed by frequent independent standing throughout the day. The letter also explains that a separate stander is not equally effective in addressing these medical conditions and will not provide the same medical benefits for Linda.

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P-13 000287 BCM :SayJor College o/Medicint;

LISA R. WENZEL, M.D. Assist:ant Pmfes~or Spiaat Cord Injury Program Phy~ical l\.fedicine & Rd1abilituion

The team responsible for conducting Linda's wheelchair evaluation in February 2013 'continues to support their recommendation for a custom power wheelchair with integrated standing feature for Linda. The Pennobil C500 VS is recommended to address Linda's medical needs and is not recommended for her convenience or the convenience of her caregivers.

Sincerely,

LisaR. Wenzel,MD Attending PhysiCian Physical Medicine and Rehabilitation Spinal Cord Jnjury Program TIRR/Memorial Hermann Hospital Baylor College of Medicine

000288 TAB 7 RBQUBST UULy ~~, •~~~ PRIOR APPRO~ # none S'l'A'l'E OF NEW YORK CME# BJ7\l;i:ass .DEPJIR'l'MEN'l' OF SOCIAL SERVICES CEN'l'ER# OHSlf FH# 185S$18J

In the Matter of the Appeal of

Mary k Dl!CISION Ali'\l'ER FA~R HEARING from a determination by the Office of Health Systems Management of the New York State Department of Health (hereinafter referred to as the Agency or OHSM)

JURISDICTION

Pursuant to Section 22 of the New York State Social Services Law (hereinafter Social Services Law) and P;zrl: 358 of the Regulations of i:he New -~' York State Department of Social Services (Title lS NYCRR, hereinafter " Regulations), a fair hearing was held on September 16, 1992, in Dutchess County, before Lewis J. Nestle, ·Administrative Law Judge. The following persons appeared at the hearing:

For the Appellant

Andrew Alter and Barbara Nectow (Mid-Hudson Legal Services), Appellant's Representative

For the Office of Health Systems Management

Submitted, personal appearance waived.

I Was the Agency's determination not to process the Appellant's vendor, Daves Wheelchair, Inc.•s prior approval request correct?

FACT FINDING t An opportunity to be heard having been afforded to all interested parties.and evidence having been taken and due deliberation having been had, it is hereby found that:

1. The Appellant has been in receipt of a Medical Assistance authorization. The Appellant.is also eligible for Medicare benefits. !I ' 1 f

2. On June 25, 1992, the Appellant's vendor, Daves Wheelchair, Inc. ! requested prior approval for an Avant wheeled walker for the Appellant. i 3. On June 26, 1992, the Agency determined to return the Appellant's l.. ~ j. vendor, Daves Wheelchair, Inc.'s prior approval request on the grounds that the vendor must bill Medicare first. j 'i . I!

Il i FH# 1858S18J

4. On July 24, 1992, the Appellant requested this fair hearing. APPLICABLE +.AW

Section 3.65-a of the Social Services Law provides in part:

2. "Medical Assistance" shall mean pal'lllent of part or all of th•f · cost of medically necessary medical, dental and remedial care, services and supplies, as authorized by this title or the regulations of the department, which are necessary to prevent, diagnose, correct or cure conditions in the person that cause acute suffering, endanger life, result in illness or infi:rmity, interfere with such person's capacity for normal activity, or threaten some significant handicap and which are furnished an eligible person in accordance with this title and the regulations of the department.

Section 364.2 of the Social Services Law provides in part, as follows:

The department of health shall be responsible for

{b) establishing and maintaining standards for all non-institutional health care and services rendered pursuant to this title,

* * * Section 2.1.4 of the New York State Medicaid Management Information System {]@ilS) Durable Medical Equipment Provider Manual defines prior approval as the process of evaluating the aspects of a plan of care which may be for a single service or an ongoing series of services in order to determine the medical necessity and appropriateness of the care requested.

Section 2.2.2.B. of the MMIS Durable Medical Equipment Provider Manual and, effective February 20, 1991, Department Regulations at 18 NYCRR sos .s {a} (l.} define "Durable Medical Equipment" as:

devices and equipment, other than prosthetic or orthotic appliances, which have been ordered by a qualified practitioner in the treatment of a specific medical condition and which have all of the.following characteristics:

Can withstand repeated use for a pr0 tracted period of time1

Are primarily and customarily used for medical purposes;

Are generally not useful to a person in the absence of an illness or injury; and

Are usually not fitted, designed or fashioned for a particular individual's use.

Where equipment is intended for use by only one patient, it may be either custom made, or customized.

-------------------------·-- 3 FH# lSSSSlSJ

"Custom-made" means fabricated soJ.ely for a particular individual and cannot be readily changed to conform to another recipient's needs. It usually requires the recipient to be measured for custom fitting and/or molding of components.

"Customized" refers to a stock item that has modifications made and/or attached (to it} to meet a recipient's needs. These modifications may be changed (by adding or deleting items such as armrests, etc.} to return the· item to stock.

Section 360-7.2 of the Department's Regulations provides: Where a third party, such as a health insurer or responsible person, has a legal liability to pay for MA-covered services on ·behalf of a recipient, the department or social servlces district will pay only the amount by which the MA reimbursement rate for the services exceeds the amount of the third party liability. The department or social services district will also pay if the third party payment will not be made within a reasonable time. The department or social services district will seek reimbursement for any payments for care and services it makes for which a third party is legally responsible. They will seek re~rnbursement to the extent of the third party's legal liability unless the amount reasonably expected to be recovered is less than the cost of making the recovery.

Section 360·7.3 of the Department's Regulations provides for the use of health, hospital or accident insurance. A recipient must use health, hospital or accident insurance benefits to the fullest extent in meeting his/her medical needs.

Section 2.2.l2f of the .MMIS Provider Manual states, in part:

When a procedure requires prior approval, prior approval must be obtained by the provider when a recipient has both Medicare and Medicaid coverage in order to receive Medicaid payment for Medicare deductibles and coinsurances except when the request involves rentals •.• I i 8 I Ij DISCUSSION

It should initially be noted that the Agency had requested a waiver of I' personal appearance which was opposed by the Appellant's counsel. The material in support of the request and in opposition to the request was I carefully reviewed and it was determined that the waiver would be granted because of the absence of any factual issues. The matter was discussed at Il the hearing and the Appellant's Representative elected to proceed with the hearing in the absence of the Agency. · 4 FH#'lBSBSlSJ

The Appellant receives both Medicare and Medical Assistance benefits. The Agency, in its submission, contended that the Appellant was required to explore Medicare approval first because the Medical Assistance Program is the payor of last resort.

The.Agency's contention is not persuasive. The issue here is a request for prior approval, not a request for payment. Although the Medical Assistance Program is the payor of last resort, the question of payment is not relevant to the issue of prior· approval. Section 2.1.7 of the Manual states that payment will not be made for medical care and services for which third parties e.g., Medicare are liable. Similarly, Section 2.1.9 of the Manual speaks to the provider·' s responsibility to bill all applicable insurance sources before submitted a claim for payment under the Medical Assistance Program. However, the Appellant is entitled to have the Agency determine whether the walker is medically necessary which is a separate and distinct question from the amount of Medical Assistance payment, if any. Under these circumstances, the Agency will be required to process the Appellant's request for prior approval and determine the medical necessity of the walker.

The Appellant's Representatives requested that the question of medical necessity be resolved at this hearing and submitted a copy of a letter dated June 15, 1992 from the Ms Comprehensive Care Center in support of the request. This request is denied. The Agency sununary indicated that the Agency had granted prior approval to make repairs to the Appellant's wheelehair. As set forth in the cited legal authority, it is the Agency's responsibility to determine medical necessity for the·purchase of durable medical equipment. Under these circumstances, the appropriate remedy when there has been an improper failure to act or when the Agency has returned a prior approval request for an improper reason, is.to require the Agency to process the request and to make a determination.

The Appellant's Representatives further contended that the rate of reimbursement set forth in the MMIS Provider Manual in this type of situation is contrary to federal law. The Manual provides that reimbursement is the lesser of the difference between what Medicare pays and ·the Medicare approved amount (the co-pay) or what Medica~e pays and the Medical Assistance rate. The Appellant's Representative contended that this limitation violates federal Title XIX requirements regarding amount, scope and duration of benefits and that a similar policy had.been enjoined in California. However, inasmuch as no determination has been made as to prior approval of the walker, it would be premature to address the question as to the amount of payment in this decision.

DECISION AND ORDER

The determination of the Agency not to process the Appellant's vendor, Daves Wheelchair, Inc.•s prior approval request is not correct and is reversed. l ~

Ir J. s FH# l858518J

The Agency is directed to detem~~Ef:\Yh,'i,the~ t~? ~y~t wh~el walk

. As i;equired by Department !iegu~atio>;ls ~t i.a ?n'CR.R asa-6 .. 4, the AgenGr ' · must comply immediately with the d.ire.ctiirl!s set :f¢r~h ¥P\'El· ·. DATED: Albany, New York

ocr oI 1992 NEW YORK STATE DEPARTMENT OF SOCIAL SERVICES

By

~ ~.~ Commissioner's Designee

t 1 I i I i' !l l ' i- i TAB 8 HHSC Fair and Fraud Hearings Handbook (Excerpt)

1565 Agency Action Notice Issues Revision 11-4; Effective June 1, 2011

Whenever an adverse action is taken, programs are required to send an adequate notice to the client. Federal law sets out what is to be included in adverse action notices. If the appellant raises an issue at the hearing questioning the sufficiency of the notice, the hearings officer must address the issue at that time. The hearings officer may direct the agency to send a con-ected notice, in accordance with all legal requirements. The appellant may choose to waive any notice issues and continue with the hearing.

Notices are of particular impo1tance in nursing facility discharge hearings and in Personal Care Service hearings and adequacy of the notices must be addressed as an issue within the hearing in addition to other issues listed as the basis for the intended adverse action. In these appeals, if the notice issue is not raised by the appellant, the hearings officer must develop the record to include information to determine the legal adequacy of the notice.

1565.1 When Appellant Raises a Notice Issue

Revision 10-1; Effective January 15, 2010

If the appellant raises a notice issue, either directly or indirectly, it must be dealt with by the hearings officer on the record. The appellant has the right to receive adequate notice. However, the appellant can waive any notice issues and continue with the hearing. It is the hearings officer's responsibility to establish if the appellant wants to waive any issues on adequate notice. If the appellant waives any notice issue, then the hearing can proceed and notice is no longer an issue.

If the hearings officer determines that the notice is not adequate and appellant does not waive his right to receive adequate notice, the hearings officer instructs the agency representative to prepare a new notice and provide it to the appellant. After the new notice is provided, the hearings officer reconvenes the hearing.

Notice issues raised and how they were resolved should be noted in the hearings officer's decision under Procedural History.