Texas Health and Human Services Commission v. Jessica Lukefahr
Opinion
ACCEPTED 03-15-00325-CV 8285331 THIRD COURT OF APPEALS AUSTIN, TEXAS 12/17/2015 1:52:17 PM JEFFREY D. KYLE CLERK No. 03-15-00325-CV _________________________________ FILED IN IN THE 3rd COURT OF APPEALS AUSTIN, TEXAS THIRD COURT OF APPEALS 12/17/2015 1:52:17 PM AUSTIN, TEXAS JEFFREY D. KYLE _________________________________ Clerk
TEXAS HEALTH AND HUMAN SERVICES COMMISSION, Appellant,
v.
JESSICA LUKEFAHR, Appellee. _________________________________
On Appeal from the 345th Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-002158 The Honorable Stephen Yelenosky, Presiding _________________________________
APPELLEE’S RESPONSE BRIEF _________________________________
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 TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................i
TABLE OF AUTHORITIES .................................................................................... ii
ARGUMENT ............................................................................................................. 2
I. HHSC’s Exceptional Circumstances Rule Does Not Require the Submission of “Medical Literature” to Establish Medical Necessity for DME........................................................................................ 2
II. HHSC’s Explanation for the Agency’s Lack of Criteria for Integrated Standers Has No Merit ................................................................. 4
III. The Parties Agree that Jessica was Not Required to Seek Prior Authorization of a Separate Stander as Part of Her Request for a Custom Power Wheelchair with Integrated Stander .................................. 6
IV. HHSC Failed to Refute the Professional Opinion of Jessica’s Treating Medical Providers that She Cannot Utilize a Separate Stander........................................................................................................... 7
V. HHSC’s Defense of TMHP’s Denial Notice Does Not Affect the District Court’s Decision......................................................................... 8
CONCLUSION AND PRAYER ............................................................................... 9
CERTIFICATE OF COMPLIANCE ....................................................................... 10
CERTIFICATE OF SERVICE ................................................................................ 10
i TABLE OF AUTHORITIES
CASES
Koenning v. Janek, 539 F. App’x 353 (5th Cir. 2013) ......................................................................... 4
Koenning v. Suehs, 897 F. Supp. 2d 528 (S.D. Tex. 2012) .................................................................. 4
TGS–NOPEC Geophysical Co. v. Combs, 340 S.W.3d 432 (Tex. 2011) ................................................................................ 2
REGULATIONS
1 TEX. ADMIN. CODE § 354.1039(a)(4)(D) ............................................................ 2, 3
42 C.F.R. § 431.12 ..................................................................................................... 3
STATUTES
42 U.S.C. § 1396a(a)(17) ........................................................................................... 4
ii No. 03-15-00325-CV _________________________________
IN THE THIRD COURT OF APPEALS AUSTIN, TEXAS _________________________________
JESSICA LUKEFAHR, Appellee. _________________________________
On Appeal from the 345th Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-002158 The Honorable Stephen Yelenosky, Presiding _________________________________
TO THE HONORABLE COURT OF APPEAL:
On December 7, 2015, more than 30 days after the filing of Appellee’s Sur
Reply, Appellant Texas Health and Human Services Commission (HHSC) filed a
Response to Appellee’s brief.1 As before, Appellee, Jessica Lukefahr, respectfully
responds to Appellant’s most recent brief to address the matters addressed therein.
1 To the extent additional briefing is allowed, Tex. R. App. P. 38.6(c) suggests that such briefs must be filed within 20 days of the preceding brief. As such, HHSC’s Response Brief is untimely. 1 ARGUMENT
I. HHSC’s Exceptional Circumstances Rule Does Not Require the Submission of “Medical Literature” to Establish Medical Necessity for DME.
HHSC claims its denial of Jessica’s wheelchair request “should have been
affirmed” because she “failed to provide evidence-based medical peer-reviewed
literature in support of her exceptional circumstances request.2 Appellant’s
Response Brief, pp. 2-3. This is incorrect.3 HHSC’s exceptional circumstances rule,
1 TEX. ADMIN. CODE § 354.1039(a)(4)(D), neither mandates nor mentions the
submission of medical literature to establish that a requested item of durable medical
equipment (DME) will meet a “specific medical purpose.”4 As explained by HHSC
at a recent public meeting, this “medical literature” requirement “has not been
previously posted in [agency] policy nor has that process been in Rule.” App. B, p.
2:16-18.
2 In fact, the medical literature submitted on Jessica’s behalf collectively reviews more than 40 research studies investigating the medical and functional benefits of supported standing. See Appellee’s Brief, pp. 24-26. Appellant’s assertion that this literature did not rise to the level of research required by TMHP’s process is incorrect. Appellant’s Response, p.3. 3 HHSC’s hearing decision contains no finding concerning this “medical literature” requirement. 4 Administrative rules must be construed “in the same manner as statutes” and the plain language of this rule does not include the “medical literature” requirement upon which HHSC relies. See TGS–NOPEC Geophysical Co. v. Combs, 340 S.W.3d 432, 438 (Tex. 2011) (citation omitted). 2 In fact, this provision derives from an internal exceptions process established
by the Texas Medicaid and Healthcare Partnership (TMHP) in October 2012.5 As
part of this process, DME suppliers are informed they must submit:
a minimum of two articles from evidence-based medical peer-reviewed literature that demonstrate validated, uncontested data for use of the requested equipment to treat the recipient’s specific medical condition, and that the requested equipment has been found to be safe and effective.
TMHP’s “medical literature” requirement is an unreasonable standard for
determining eligibility for DME. This was recently demonstrated when HHSC
failed in its attempt to add this requirement to 1 TEX. ADMIN. CODE §
354.1039(a)(4)(D). In June 2015, HHSC submitted this proposed rule amendment
to the agency’s Medical Care Advisory Committee (MCAC).6 The MCAC flatly
rejected HHSC’s proposed “medical literature” requirement and unanimously voted
to send the rule amendment back to the agency.7 As explained by a MCAC member
and former medical director for HHSC:
Free access — add to your briefcase to read the full text and ask questions with AI
ACCEPTED 03-15-00325-CV 8285331 THIRD COURT OF APPEALS AUSTIN, TEXAS 12/17/2015 1:52:17 PM JEFFREY D. KYLE CLERK No. 03-15-00325-CV _________________________________ FILED IN IN THE 3rd COURT OF APPEALS AUSTIN, TEXAS THIRD COURT OF APPEALS 12/17/2015 1:52:17 PM AUSTIN, TEXAS JEFFREY D. KYLE _________________________________ Clerk
TEXAS HEALTH AND HUMAN SERVICES COMMISSION, Appellant,
v.
JESSICA LUKEFAHR, Appellee. _________________________________
On Appeal from the 345th Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-002158 The Honorable Stephen Yelenosky, Presiding _________________________________
APPELLEE’S RESPONSE BRIEF _________________________________
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 TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................i
TABLE OF AUTHORITIES .................................................................................... ii
ARGUMENT ............................................................................................................. 2
I. HHSC’s Exceptional Circumstances Rule Does Not Require the Submission of “Medical Literature” to Establish Medical Necessity for DME........................................................................................ 2
II. HHSC’s Explanation for the Agency’s Lack of Criteria for Integrated Standers Has No Merit ................................................................. 4
III. The Parties Agree that Jessica was Not Required to Seek Prior Authorization of a Separate Stander as Part of Her Request for a Custom Power Wheelchair with Integrated Stander .................................. 6
IV. HHSC Failed to Refute the Professional Opinion of Jessica’s Treating Medical Providers that She Cannot Utilize a Separate Stander........................................................................................................... 7
V. HHSC’s Defense of TMHP’s Denial Notice Does Not Affect the District Court’s Decision......................................................................... 8
CONCLUSION AND PRAYER ............................................................................... 9
CERTIFICATE OF COMPLIANCE ....................................................................... 10
CERTIFICATE OF SERVICE ................................................................................ 10
i TABLE OF AUTHORITIES
CASES
Koenning v. Janek, 539 F. App’x 353 (5th Cir. 2013) ......................................................................... 4
Koenning v. Suehs, 897 F. Supp. 2d 528 (S.D. Tex. 2012) .................................................................. 4
TGS–NOPEC Geophysical Co. v. Combs, 340 S.W.3d 432 (Tex. 2011) ................................................................................ 2
REGULATIONS
1 TEX. ADMIN. CODE § 354.1039(a)(4)(D) ............................................................ 2, 3
42 C.F.R. § 431.12 ..................................................................................................... 3
STATUTES
42 U.S.C. § 1396a(a)(17) ........................................................................................... 4
ii No. 03-15-00325-CV _________________________________
IN THE THIRD COURT OF APPEALS AUSTIN, TEXAS _________________________________
JESSICA LUKEFAHR, Appellee. _________________________________
On Appeal from the 345th Judicial District Court of Travis County, Texas Trial Court Case No. D-1-GN-14-002158 The Honorable Stephen Yelenosky, Presiding _________________________________
TO THE HONORABLE COURT OF APPEAL:
On December 7, 2015, more than 30 days after the filing of Appellee’s Sur
Reply, Appellant Texas Health and Human Services Commission (HHSC) filed a
Response to Appellee’s brief.1 As before, Appellee, Jessica Lukefahr, respectfully
responds to Appellant’s most recent brief to address the matters addressed therein.
1 To the extent additional briefing is allowed, Tex. R. App. P. 38.6(c) suggests that such briefs must be filed within 20 days of the preceding brief. As such, HHSC’s Response Brief is untimely. 1 ARGUMENT
I. HHSC’s Exceptional Circumstances Rule Does Not Require the Submission of “Medical Literature” to Establish Medical Necessity for DME.
HHSC claims its denial of Jessica’s wheelchair request “should have been
affirmed” because she “failed to provide evidence-based medical peer-reviewed
literature in support of her exceptional circumstances request.2 Appellant’s
Response Brief, pp. 2-3. This is incorrect.3 HHSC’s exceptional circumstances rule,
1 TEX. ADMIN. CODE § 354.1039(a)(4)(D), neither mandates nor mentions the
submission of medical literature to establish that a requested item of durable medical
equipment (DME) will meet a “specific medical purpose.”4 As explained by HHSC
at a recent public meeting, this “medical literature” requirement “has not been
previously posted in [agency] policy nor has that process been in Rule.” App. B, p.
2:16-18.
2 In fact, the medical literature submitted on Jessica’s behalf collectively reviews more than 40 research studies investigating the medical and functional benefits of supported standing. See Appellee’s Brief, pp. 24-26. Appellant’s assertion that this literature did not rise to the level of research required by TMHP’s process is incorrect. Appellant’s Response, p.3. 3 HHSC’s hearing decision contains no finding concerning this “medical literature” requirement. 4 Administrative rules must be construed “in the same manner as statutes” and the plain language of this rule does not include the “medical literature” requirement upon which HHSC relies. See TGS–NOPEC Geophysical Co. v. Combs, 340 S.W.3d 432, 438 (Tex. 2011) (citation omitted). 2 In fact, this provision derives from an internal exceptions process established
by the Texas Medicaid and Healthcare Partnership (TMHP) in October 2012.5 As
part of this process, DME suppliers are informed they must submit:
a minimum of two articles from evidence-based medical peer-reviewed literature that demonstrate validated, uncontested data for use of the requested equipment to treat the recipient’s specific medical condition, and that the requested equipment has been found to be safe and effective.
TMHP’s “medical literature” requirement is an unreasonable standard for
determining eligibility for DME. This was recently demonstrated when HHSC
failed in its attempt to add this requirement to 1 TEX. ADMIN. CODE §
354.1039(a)(4)(D). In June 2015, HHSC submitted this proposed rule amendment
to the agency’s Medical Care Advisory Committee (MCAC).6 The MCAC flatly
rejected HHSC’s proposed “medical literature” requirement and unanimously voted
to send the rule amendment back to the agency.7 As explained by a MCAC member
and former medical director for HHSC:
5 HHSC explained this at the public meeting: In our Medical policy and Rules, we specifically lay out what DME is available to Medicaid clients. There are lots of DME products though, as you can imagine, and there not all listed in policies, so for an adult who wants access to a DME, a piece of DME that is not currently listed in policy, there is a process that takes place. This process has been in place since October of 2012. App. B, p. 2: 3-12. 6 Pursuant to 42 C.F.R. § 431.12, state Medicaid programs are required to establish such committees to participate “in policy development and program administration…” 7 One committee member expressed her concern that this new requirement would be “absolutely burdensome” and “absolutely have a negative impact on the Medicaid members.” App. B, p. 7: 20-23. Another member voiced similar concerns: I, too am quite concerned about this, coming from a university environment to find uncontested data or - - you know, you can always find something to counter one 3 In the meantime, I would like HHSC to explore a way to kind of back off from what seems to me on the face of it to be a very inappropriate standard of proof … So how you could put that standard of proof on these items is sort of beyond me…and also, if I understand correctly, the process we’re talking about here applies to adults, correct? So it doesn’t apply to EPSDT [Children’s Medicaid Services]. So somebody who is 20 years old and six months could get the exact same piece of requested equipment without having this standard applied to them - - or this process applied to getting this piece of equipment.
App. B, p. 18:5-8; 13-20 (Statement of Dr. John Hellerstedt)
This requirement violates the Medicaid Act’s reasonable standards provision,
42 U.S.C. § 1396a(a)(17), and is contrary to the plain language of the agency’s
exceptional circumstances rule.8 As such, this “very inappropriate standard of
proof” provides no basis for reversing the district court’s decision.
II. HHSC’s Explanation for the Agency’s Lack of Criteria for Integrated Standers Has No Merit.
HHSC’s purported rationale for the agency’s lack of clinical criteria for
determining whether a wheelchair standing feature will serve a specific medical
study [with] another… But the other thing I have heard that causes me concern is that one, I’ve never heard - - when you have a physician and a PT and an OT saying that this is going to be useful, I’ve never heard of the client having to go and research and find these - - you know, proof and find these studies. You know, many clients can’t do that. Many providers can’t do that… So I really have some problems with this and will have to vote against it because I think it is unreasonable to expect, you know, the providers and the clients to go do this scientific research. App. B, p. 8: 9-12; 17-22, p. 9:7-10. 8 Prior to 2012, HHSC did not allow exceptional circumstance appeals for wheelchairs with integrated standing features. Following the district court’s decision in Koenning v. Suehs, 897 F. Supp. 2d 528, 552-53 (S.D. Tex. 2012) vacated sub nom. Koenning v. Janek, 539 F. App’x 353 (5th Cir. 2013), HHSC made this review available to Medicaid beneficiaries seeking this item of DME, but allowed TMHP to add its “medical literature” requirement to the process. 4 purpose does not support reversal of the district court’s decision. To the contrary,
this argument further demonstrates that the district court correctly found the
agency’s decision to be arbitrary and capricious. CR 226.
HHSC’s hearing decision clearly stated that the agency’s Office of Medical
Director “determined that the client’s condition did not meet the clinical criteria for
the Exceptional Circumstances provision for a Permobil C500 VS power wheelchair
with integrated standing feature.” (emphasis added). Appellant’s Brief, App. B, AR
571, Finding of Fact No. 9; App. C, AR 589, Finding of Fact No. 9. Faced with the
fact that HHSC’s witnesses could not identify a single clinical criterion applied to
requests for wheelchairs with integrated standers or to name a single medical
purpose that could justify approval of an integrated stander, the agency now argues
that “no set clinical criteria” exists so that the agency can consider these requests on
an “individual case basis.” Appellant’s Response Brief, p. 3. This rationale does not
explain the apparent contradiction between the agency's specific finding of fact on
this point and its argument on appeal. Nor does it explain why HHSC’s witnesses
could not identify the criteria applied “on an individual case basis” to Jessica’s
specific request. At the fair hearing, HHSC's inability to provide this information led
to the agency’s concession that “a standing program [for Jessica] is important to
address the concerns that have been presented today. All of that documentation
justifies standing . . .” HR 1:26:55-1:27:12. See Appellee’s Brief, p.19. HHSC's
5 argument does not support its contention that the hearing decision “should have been
affirmed” Appellant’s Response Brief. p.4.
III. The Parties Agree that Jessica was Not Required to Seek Prior Authorization of a Separate Stander as Part of Her Request for a Custom Power Wheelchair with Integrated Stander.
In its initial brief, HHSC stated that “no prior authorization request for a static
stander has been submitted to Texas Medicaid.”9 Appellant’s Brief, p.9. In response,
Jessica noted that:
HHSC suggests there is some significance to the fact that “no prior authorization request for a static stander has been submitted to Texas Medicaid.” HHSC Brief p.9. While this fact is true, it is also irrelevant. There also was no prior authorization request for a postural walker as Jessica’s medical professionals determined that both of these items of DME will not meet her medical and functional need to stand. And as the district court correctly noted, this point was not identified as a reason for the denial in TMHP’s notice to Jessica. CR 222, HHSC App. G, p. 2, n. 3.
Appellee’s Brief, p. 20, n. 20.
HHSC replied by again suggesting that the absence of a prior authorization
request for a separate stander had some bearing on the outcome of the hearing.
According to the agency, “[a]lthough Ms. Lukefahr claims that failure to request a
static stander was not provided as a reason for denial, this is contradicted by the
record.” Appellant’s Reply Brief, pp. 8-9. Whatever point HHSC intended by these
9 HHSC’s alternative contention that Jessica failed to show what alternative DME had been ruled out by her medical providers is patently erroneous, as previously explained in Appellee’s Brief, pp. 8, 13, 20-28, 31-32 and Appellee’s Sur-Reply, pp. 12-18. 6 earlier statements, HHSC now agrees there is no “requirement that alternative DME
must be requested for prior authorization prior to submitting an exceptional
circumstances request, and no such requirement exists in law or policy.” Appellant’s
Response Brief, p. 5. There is no dispute on this point. Nor is there any basis for
reversing the district court’s decision.
IV. HHSC Failed to Refute the Professional Opinion of Jessica’s Treating Medical Providers that She Cannot Utilize a Separate Stander.
Jessica’s exceptional circumstances review presented two questions: (1) does
she have a medical need for supported standing, and if so (2) is there an equally
effective alternative item of DME that will meet this medical need. As to the first
question, the district court correctly noted that “there is no evidence to contradict
[Jessica’s] treating physician’s assessment that she ‘has a medical need to standing
numerous times throughout the day to avoid the secondary conditions that result
from prolonged sitting.’” CR 224. In addressing the second question, the court
determined that “[t]here is no evidence rebutting her treating physician’s statement
that she would need assistance from a care provider to use a static stander or the fact
that she does not have a care provider throughout the day.” CR 224.
Jessica does not “conflate” these two issues as HHSC now claims. Once
HHSC’s witness conceded Jessica’s medical need to stand, the agency had the
burden to refute the professional opinion of Jessica's medical providers that a
7 separate stander will not meet her needs.10 CR 222. As previously explained, HHSC
failed to prove that a separate stander will suffice.11 Appellee's Brief, pp. 13-14, 19-
27; Appellee’s Sur-Reply, pp. 6-13. Jessica properly addressed both questions, as
did the district court. CR 222-224.
V. HHSC’s Defense of TMHP’s Denial Notice Does Not Affect the District Court’s Decision.
HHSC’s final argument in defense of TMHP’s denial notice notes that this
letter identified the agency’s exceptional circumstances rule as the legal basis for its
decision. In fact, this notice included 7 citations to federal and state Medicaid
provisions, none of which supported the agency’s identified reasons for denial. Due
process requires specific reasons for denial, which are supported by specific rules
or policy. Once identified, these reasons “constrain” HHSC at every stage of review.
CR 221. HHSC cannot come behind the notice and offer new reasons for the denial
at the hearing, in the district court, or on appeal. As before, HHSC offers no credible
argument supporting reversal of the district court’s decision.
10 HHSC’s revival of its initial claim that the “main reason for requesting a standing power wheelchair was to help [Jessica] progress at work” and “not for the treatment of [her] medical condition is illogical in light of the agency’s clear concession that she has a medical need to stand. See AR59; Appellant’s Response Brief, p. 6. As previously explained, the uncontroverted evidence established that Jessica’s medical need to stand can occur at any time, in any location. Appellee’s Brief, pp. 12-13, 20-24; Appellee’s Sur-Reply, pp. 6-12. 11 Contrary to HHSC’s assertion, Jessica has not ignored Ms. Claey’s claim the documentation did not “speak” to the need for the stander to be part of the wheelchair. HHSC’s Response Brief, p. 5. Having twice quoted this testimony in Appellee’s Brief, pp 11 and 20, Jessica has demonstrated it is erroneous and unsupported by any probative evidence in the administrative record. Certainly, HHSC’s hearing decision did not identify any evidence provided by the agency on this critical issue. Appellant’s Brief, App. B and C. 8 CONCLUSION AND PRAYER
For the reasons described in Appellee’s Brief, Sur-Reply and above, Jessica
Lukefahr respectfully requests this Court to affirm the decision of the district court
so that she can obtain the custom power wheelchair recommended by her treating
medical professionals more than two years ago.
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
9 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 2,214 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
CERTIFICATE OF SERVICE
I hereby certify that on this 17th day of December, 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:
Kara Holsinger Assistant Attorney General Office of the Attorney General P.O. Box 12548 Austin, Texas 78711
10 INTEGRITY legal support solutions
TRANSCRIPTION OF ELECTRONIC RECORDING
HEALTH AND HUMAN SERVICES COMMISSION
MEDICAL CARE ADVISORY COMMITTEE (MCAC)
JUNE 9, 2015
PARTIAL TRANSCRIPT OF MEETING
ITEM #20 : EXCEPTIONAL CIRCUMSTANCES, CHAPTER 354
LAURIE VANHOOSE, DIRECTOR, POLICY DEVELOPMENT, HHSC
MEMBERS PRESENT:
Gilbert Handal, MD, Chair Colleen Horton, Vice Chair Edgar Walsh, R. Ph Mary Helen Tieken, RN George Smith, DO Donna Smith, PT Michele Bibby John Hellerstedt, MD Elvia Rios Doug Svien William Galinsky, HPAC Representative
MEMBERS ABSENT:
Joane Baumer, MD, PP AC Representative
ORIGINAL Austin Dallas Houston San Antonio tel l512 l320 8690 tel l972 l364 9777 tel l281 l471 8500 tel 1210 1277 6200
APPENDIX B In 1512 1320 8692 lu 1972 1364 9778 In 1281 1471 8504 In 1210 1211 6232
3100 West Slaughter Lane I Suite 101 I Austin, Texas 78748 I loll free 877 720 8690 I loll free fax 866 720 8692 I www.inlegrily·lexas.com A d i o Transcription - 6 / 9 / 2 0 15 2 1 ( Partial transcript begins at 2 : 1 0 : 35 p.m . )
2 DR . HANDAL : Item Number 2 0 .
3 MS. VANHOOSE : Okay . So Item Number 2 0 is related
4 to Durable Medical Equipment . In our Medical Policy and
5 Rules , we specifically lay out what DME is available to
6 Medicaid clients . There are lots of DME products though , as
7 you can imagine , and they're not all listed in policies , so
8 for an adult who wants access to a DME -- a piece of DME
9 that is not currently listed in policy , there is a process
10 that takes place .
11 This process has been in place since October of
12 2012 and what we were trying to do with the intent of these
13 Rules is to ensure that that process that is taking place
14 for a provider to request a piece of DME that is not spelled
15 out i n medical policy for a client , that that process they
16 go through is in Rule and is outward facing . It has not
17 been previously posted in our policy , nor has that process
18 been in Rule .
19 So the intent of these Rules is to put that
20 process in Rule .
21 We have heard from some stakeholders that there
22 are concerns with the process , and you'll hear some comments
23 today .
24 Specifically the issue is that if a provider wants
25 to request additional DME or DME that ' s exceptional , they
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcription - 6/9/2015
3 1 have to provide a minimum of two articles . You ' ll see that
2 in Section -- Subsection (d ) ( 6 ) of the Rule . There ' s
3 concerns with that being part of the process .
4 What those two peer reviewed evidence based pieces
5 of literature are used , are to ensure that the device is
6 safe and effective for the client . It is the process that
7 is currentl y being used at TMHP and with our office and
8 Medical Director to review these requests.
9 We met with a stakeholder yesterday and we
10 heard the concerns , and you ' ll hear more concerns toda y , and
11 what I ' ve coromitted t o do is to look at other States to see
12 if there are any other best practices and what those
13 processes are as we move for ward with these Rules . The
14 intent , though , is to ens u re whatever that process is , that
15 we have it in Rule .
16 So we ' ll continue to wo rk with stakeholders to
17 have a conversation arou nd the issues they have with this
18 piece of the process .
19 And j u st to clarify , this is mostly for adults ,
20 children , under EPSDT . If they need a device , they can
21 submit a form -- a prior authorization form . It goes
22 through the same process as any other DME and it ' s
23 reviewed for medical necessity .
24 MS . BIBBY : I have a question .
25 DR . HANDAL: Yes . Mi chele?
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcription - 6/9/2015
4 1 MS . BIBBY : So you said that you met with " a "
2 stakeholder yesterday?
3 MS . VANHOOSE : Yeah . We sent the Rules out and we
4 had a comment , an email . We received an email that a
5 stakeholder was concerned and so we sat down and met with
6 her to hear about her concerns . It ' s always
7 MS . BIBBY : So when you sent the Rule out , how
8 long was that window for comrnents to be received?
9 MS. VANHOOSE : So this is it ' ll officially be
10 posted in the Register , but what we're trying to do in my
11 area , what I encourage my staff is , when they ' re working on
12 Rules or Policies , that they send that out to stakeholders
13 that they ' re aware may have concerns or issues , so we know
14 what the issues are before we come to MCAC so that we can
15 try and address them before they even get posted in the
16 Register .
17 MS . BIBBY: So did your staff receive any response
18 from stakeholders?
19 MS. VANHOOSE : Yeah , on a regular basis with our
20 Rules and Policie s.
21 MS . BIBBY : I mean , I ' m trying to understand , was
22 it not until yesterday that you were aware -- excuse me , I
23 have a cold -- that there were concerns?
24 MS . VANHOOSE : Yes . Me personally , yes.
25 MS . BIBBY : And you weren ' t aware of that until
Integrity Legal Support Solutions APPENDIX B www . integrity - texas.com Audio Transcription - 6 /9/ 2 0 15
5 1 yesterday?
2 MS . VANHOOSE : Yes , yes .
3 MS . BIBBY : Okay.
4 MS . VANHOO SE : Oh , I mean , we met yesterday . I
5 received the concern a week or so ago .
6 MS . BIBBY: Okay. And you ' re planning -- your
7 plan is to meet with other stakeholders?
8 MS . VANHOOSE : Yeah , any stakeholders that have
9 concerns with the Rules , yes , we will definitely meet with
10 them .
11 MS . BIBBY : Okay . And this two - step process , is
12 that consistent with CMS guidance?
13 MS . VANHOOS E : So it is a process that the State
14 has put in place for a service that is not currently a
15 defined s ervice. So we have the authority to review
16 requests for services that are not defined in policy in our
17 State plan in the process that we've established . So this
18 process that was established was that the provider submit
19 this information that ' s required in the Rule to TMHP . TMHP
20 Medical Directors review the information that ' s provided ,
21 and then it goes to our office of Medical Director and the
22 Medicaid Medical Director makes the final determination on
23 whether or not we will allow for that DME .
24 MS . BIBBY : Okay . I'm understanding what you ' re
25 saying . I ' m a former employee of the HHSC Office of the
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . com Audio Transcription - 6 / 9 / 2 0 15
1 Ombudsman . And we received tons of complaints about
2 Medicaid members , who had requests for Durable Medical
3 Equipment that was endorsed by their physician , denied .
4 So the question that I ' m asking is : Is there some
5 guidance from CMS that is different from this two - step
6 process that you're saying that the State is entitled to
7 rightfully put in place?
8 MS. VANHOOSE: What we can do is : Like I
9 committed to the stakeholder yesterday , is we ' ll look at
1 0 other States' best practices and we can see what is there ,
11 but this is a process for -- we do not have to have
12 permission from CMS to offer benefits outside of our State
13 plan . We have the authority over determining what those
14 benefits are , and this was the process . CMS does not review
15 our processes, they re v iew what we're offering. So this is
16 the process that was put in place , but I understand there
17 are concerns related to it . So I ' ve committed to go back
18 and work to see if this is the right process or not.
19 MS . BIBBY : Well, I'm not so much concerned about
20 processes. I'm concerned about what is in the best interest
21 of Medicaid members , and so , I would hope that if it is the
22 best practice of many other States , that the State of Texas
23 Medicaid Program would look at following the lead of perhaps
24 those more forward - thinking States in terms of what is in
25 the best interest of Medicaid members .
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcription - 6/9 / 2015
7 1 MS . VANHOOSE : I agree .
2 MR . JESSEE: Can I just ask for clarification?
3 DR . HANDAL: Yes .
4 MR . JESSEE: So Michele , what -- the issue that
5 you have specifically is, is it that somebody's determining
6 medical necessity outside the physician ' s recommendation and
7 that there ' s utilizaLion management associated with the
8 request , or -- and I understand your previous role in the
9 Office of the Ombudsman , and you ' re right , but I guess the
10 point I ' m making is : Physicians make recommendations about
11 benefits today that are reviewed through MCO ' s utilization
12 management or through TMHP through utilization management.
13 So I guess the question I have for you is: I just
14 want to be clear what you ' re asking . Are you thinking that
15 the processes being put in place by the Medicaid Division is
16 going to be burdensome ,
17 MS . BIBBY : Yes .
18 MR. JESSEE : -- or potentially impact the member
19 negatively?
20 MS. BIBBY: Absolutely burdensome --
21 MR . JESSEE : Okay .
22 MS. BIBBY : -- and absolutely have a negative
23 impact on the Medicaid members .
24 MS . VANHOOSE : And we ' ve heard --
25 MR . JESSEE: Okay .
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . com Audio Transcription - 6/9/2015
8 1 MS . VANHOOS E : Yeah , and we have heard that
2 concern and this wa s a process that was developed in 2012
3 and the intent of this Rule i s to make sure it ' s transparent
4 what process is and what we ' re hearing is there ' s concerns
5 and questions about the process .
6 DR . HANDAL : Yeah .
7 MS . HORTON : Hi , Laurie .
8 MS . VANHOO SE : Hi .
9 MS . HORTON : I , too , am quite concerned about this
10 coming from a unive rsit y environment to find uncontested
11 data or you know , you can always find something to
12 counter one study in another .
13 So -- and with the way that our world is moving in
14 technology , you know , something good might really become
15 a v ailable and there may not have been an extraordinary
16 amount of research done on it y et .
17 But the other thing that I have heard that causes
18 me concern is that , one , I ' ve neve r heard -- when you have a
19 physician and a PT and a n OT sa ying that this is going to be
20 useful , I ' ve never heard of the client having to go and
21 research and find these -- you know , proof and find the
22 studies . You know , many clients can ' t do that . Many
23 providers can't do that . That takes a lot of time .
24 And you know , if you can't find a study that
25 pertains to exactly this disability in this age group and
Integr i ty Legal Support Solutions APPENDIX B www . integrity - texas . com Audio Transcription - 6/9/2015
9 1 I ' ve heard it , you know , these studies are being rejected
2 because , you know , oh , well yeah , they had the same
3 disability , but it was a different age group , or that they
4 were the same age group , but they had a different
5 disability , even though their need -- functional need was
6 the sa_ e .
7 So I really have some problems with this and will
8 have to vote against it because I think it's unreasonable to
9 expect , you know, the providers and the clients to go do
10 this scientific research .
11 MS . TIEKEN: I would like to comment as a home
12 health provider . I find it unsettling that the
13 organizations that represent home health industries in our
14 State were not consulted about this and if they were , I
15 apologize for that , but I don ' t think they were .
16 And if we , as providers , are not able to give you
17 feedback and information and our perspectives on this
18 particular issue and others , then I don ' t think you've done
19 a service to our State , our -- the patients we serve and the
20 providers who have to try to do that.
21 I can hardly get skilled nursing visits approved ,
22 much less go through this rigmarole to get somebody some
23 DME. I just -- I couldn't support this as it is .
24 DR . HANDAL : I hear --
25 MS. VANHOOSE : I understand. I'm not sure what
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . corn Audio Transcription - 6/9/2015
10 1 process was used when this was developed . This was under
2 our Office of Medical Director and I appreciate your concern
3 about input. This is to
4 DR . HANDAL: I have
5 MS. VANHOOSE : -- process to make sure that it ' s
6 you at least know what it is we're doing .
7 DR . HANDAL: Laurie , Gary can verify that I have
8 the same concern. I ' ve seen people needing sometimes basic
9 stuff and not getting approved. So you know , I understood
10 this was a way to streamline and help , but it really is not .
11 It ' s not . That ' s my concern. It's really not helping.
12 MR . JESSEE : Yeah , I think the Rule was intended
13 to provide some transparency and perhaps the transparency is
14 where it ' s creating some additional concerns . So I mean , I
15 think we ' re committed to going back and looking at that .
16 I guess a question I had for you , Laurie , and you
17 may not know this is , because the original policy that's
18 been in place since 2012 is unclear, has that resulted in
19 just across the board denials of these DME -- of these needs
20 or is the concern that because it was unclear , there was
21 more approvals that people anticipate will no longer be
22 approved or do you have any data on what the amount of
23 denials?
24 MS . VANHOOSE : I have the data , but I think you ' ve
25 raised a good point . There's probably providers that don ' t
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcription - 6/9/2015
11 1 even know the process exists since it ' s not published , but I
2 think there's definitely stakeholders here that can speak to
3 concerns they have heard regarding how the process has
4 worked in practice .
5 MR . JESSEE : So we have the -- so I guess the
6 answer is : There is the ability to go back and visit some
7 more about the policy and maybe even consider , you know ,
8 what ' s the appeal -- I mean , there is an appeals process and
9 all of that , but I agree . I mean , it seems -- it would seem
10 difficult for one provider may have the expertise or ability
11 to push forward some support or research , but another
12 provider may not and in the end , one member may benefit and
13 one may not .
14 MS . VANHOOSE : Yeah . No , I think we can review
15 it . There needs to be a standard . You know , we ' re just
16 trying to put a standard in place to ensure that we are
17 appropriately providing services that are safe and effective
18 and what I've heard from many people is this may not be that
19 standard .
20 DR . HANDAL : Dr. Walsh?
21 DR . WALSH : I just wanted to ask , do we have
22 testimony by anyone?
23 DR . HANDAL : Yeah , we have two testimonies -- we
24 have three testimonies actually .
25 So if you don't mind , let me hear the testimony
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . com Audio Transcription - 6/9/2015
12 1 first , you know.
2 Ms . Maureen O'Connell?
3 !VIS . 0 CONNELL : I Good morning . My name is Maureen
4 O'Connell , and I think I ' m also known as the " a "
5 stakeholder , because I was the one that met with HHSC
6 yesterday.
7 I thank you for the opportunity to talk today
8 about this . As ypu know, this process has actually been in
9 effect since October of 2012 . During that time , our office,
10 the Southern Disability Law Center , has represented nine
11 individuals who were caught up in this special exceptional
12 circumstances process . And it is our opposition to the Rule
13 is based on the experience of these clients.
14 To answer a question about the data , I did a
15 Public Record request on the data between October 12th
16 October 2012 and March 2015. There were nine requests for
17 exceptional circumstances review on items of DME . Seven of
18 them were denied . One of them that was approved was
19 actually one of the Plaintiffs in the Federal lawsuit , so --
20 and she was the first to go , so she actually got approved .
21 One other person , we don't know exactly what that was about ,
22 but apparently they were approved , too .
23 There's good reason not to move forward with this ,
24 and I put that in my comments, is we are at the point where
25 CMS is just ready to issue their final DME Rules . We know
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . corn Audio Transcription - 6 / 9 / 2 01 5
13 1 these Rules are going to c h ange e v erything because for t h e
2 first time since 1965 , we are going to have a Federal
3 definition of DME that all States must comply with . Right
4 now every State can define it anyway they wish . That will
5 no longer be the case .
6 Because the Federal definition of DME will change
7 the scope of the benefit , it ' ll be clearl y defined scope of
8 benefit . We cannot move forward with creating an exceptions
9 process when we don ' t have the scope fully outlined . It
10 doesn ' t make any sense.
11 We also know that this -- the way it ' s set up
12 right now is a two - step process . You have to go through a
13 prior authorization process . You have to get denied . You
14 have t o ha v e your DME pro v ider request exceptional
15 circumstances appeal and then you'll get denied there .
16 I have talked about the fact that this is
17 extremely time consuming . One client -- the exceptional
18 circumstances process alone -- not the prior authorization ,
19 just the exceptional circumstances process took six months .
20 She got denied and then went to a fair hearing . Before it
21 wa s all over with the fair hearing , one year had passed
22 since the first request for this particular wheelchair .
23 The untimeliness of it is a huge problem for the
24 clients. It ' s also very , very burdensome in that they have
25 to go for so long only to be told no at the end .
APPENDIX B Integrity Legal Support Solutions www . integrity- texas . com Audio Transcription - 6/9/2015
14 1 In particular, the problem -- and you -all have
2 addressed it is this requirement for research. And I
3 gave an opinion -- I gave an example in one of my -- of one
4 of my cases in my notes .
5 Oh , I'm up. Anyway , should I stop?
6 DR . HANDAL : I think it's clear now . Really ,
7 we've heard so much . There is other witnesses . If you
8 don 't mind , if we have time later on , we 'll give you more
9 time.
10 Susan Murphree?
11 I thank you so much for taking your time .
12 MS . O ' CONNELL : Okay . Thank you .
13 MS . MURPHREE: Good afternoon. I'm Susan
14 Murphree . I'm representing Disability Rights Texas . Thank
15 you for the opportunity to provide comments on t h is item .
16 I just want to start off and end up with a request
17 to delay any action on this . In terms of a balanced
18 approach, it is good to move toward a more transparent ,
19 understandable system, but it is not g ood necessarily to
20 make it more complex, create a delay for important ser v ices,
21 or just rely heavily either on research or what other States
22 are doing . Sometimes we might be the leader i n what is best
23 for people .
24 I think we can be instructed by that, but to have
25 the whole Medicaid policy based on evidence based and not ,
Integrity Legal Support Solutions APPENDIX B www.integrity - texas.com Audio Transcription - 6 / 9/2015
15 1 you know , ba _ancing that with the consideration of a
2 treating physician or other healthcare provider , who
3 actually has first - hand knowledge of the individual and can
4 reall y understand what the need is .
5 So the timing is really poor . It's just three
6 months from now to where the CMS guidance will be available .
7 It's already been proposed , already received comments.
8 We're just waiting for the -final outcome .
9 So it is a bit mysterious and curious as to why we
10 need to rush through with these rules . So while we support
11 having transparency , we also are concerned about the
12 stakeholder input .
13 I participated at the invitation of HHSC, I think
14 it was a year ago or maybe a little less , on a workgroup
15 where they were looking at how the Medicaid Office would
16 determine Medicaid policy . Evidence base was one of the
17 criteria , so research e v idence base , but several of us on
18 the committee did express concern with relying way heavily
19 on that and not relying on the medical necessity needs of
20 the Medicaid participant .
21 So you know, we really didn ' t understand what
22 " uncontested " research meant and this is not a Legislative
23 mandate , as you ' ve had with some of the other Agenda items
24 or informational items . So the timeline is really sort of
25 up to this State in terms of when to come out with an actual
Integrity Legal Support SolutionsAPPENDIX B www.integrity - texas.com Audio Transcription - 6 / 9 / 20 _ 5 16 1 Rule and we ask that you de _ay -- ask that that be delayed
2 so you can get the Federal guidance , and then we can come
3 out with a Rule and all of the concerns that you - all have
4 mentioned , we share as well.
5 So thank you for the opportunity to comment .
6 DR . HANDAL: Thank you , Ms . Murphree. We
7 appreciate you.
8 Ms . Hammon , Rachel Hammon?
9 MS . HAMMON : Good morning . My name is Rachel
10 Hammon. I'm the Executive Director for the Texas
11 Association for Home Care and Hosp~ce.
12 In order to try and keep my comments brief , I do
13 want to say I concur with all of the previous comments that
14 were made and to support some of the points that have been
15 made up on the dias toda y .
16 We found out about the Rule yesterday when the
17 links went live . So we didn't know that this was happening ,
18 but we do want reiterate that we d o appreciate the attempts
19 at transparency , as well .
20 But again, I concur with all the concerns that
21 we ' ve heard today about this particular Rule and really
22 would like to ask your support and reiterating that
23 stakeholder input could be very valuable in shaping this
24 Rule and a better Rule in the future. You know , certainly
25 input would have been ver y valuable in the formulation of
Integrity Legal Support Solutions APPENDIX B www . integrity - texas.com Audio Transcription - 6 / 9 / 2015
17 1 this Rule i n terms of the timing . Maybe it would have been
2 reconsidered in terms of the timing and then some of the
3 i nformation related to this two -s tep process , as well , which
4 has been very over - burdensome . You know , it's s omewhat
5 unclear as to why if on e pro v i der submits good evidence
6 ba se d research, why that would be kind of kept in the hole
7 and not really then se t as the standard for maybe another
8 person that has the same issue .
9 So I mean , there is a lot of comments that we
10 could have made really in working with HHSC and would
11 appreciate that opportunity in the future and would
12 appreciate holding back on these Rule s. ~- 13 DR . HANDAL : Thank you so much .
14 MR . HELLERSTEDT : Well , I didn 't have a que sti on
15 for you .
16 MS . HA..l'1MON : Yes , sir .
17 MR . HELLERSTEDT : I just want to sort of want to
18 make some general points and maybe ask Ms . VanHoose -- am I
19 pronouncing the name right? -- to comment a little bit .
20 First of all , the idea that CMS ha s not defined
21 DME makes complete se n se to me to wa it for that to happen
22 before adopting any kind of Rule . Having been a Medic aid
23 Med i cal Directo r at one point in my career , this is a very
24 knotty problem , and I think having -- waiting to have that
25 clarity ser ves everybody ' s interest , and then once that
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcript~on - 6/9/2015
18 1 defin~tion comes out , I' m sure it'll be crystal clear and
2 there will be no con~roversy at all .
3 (Laughter . )
4 MR . HELLERSTEDT : Then you can involve the
5 stakeholders an additional - - in additional discussions . In
6 the meantime , I would like HHSC to explore a way to kind of
7 back off from what seems to me on the face of it to be a
8 very inappropriate standard of proof to and stop me if
9 I'm wrong , but when we're talking about DME , we ' re not
10 talking abo ut FDA- approved drugs or medical devices , things
11 that have to go through a rigorous kind of proof of safety
12 and efficacy .
13 So how you could put that standard on these items
14 is sort of beyond me , so if there's a -- and also, if I
15 understand correctly, the process we're talking about h ere
16 applies to adults , correct? So it doesn ' t apply to EPSDT .
17 So somebody who is 2 0 years old and six months could get the
18 exact same piece of requested equipment without having this
19 standard applied to them -- or this process applied to
20 getting that identical piece of equipment .
21 And I realize that ' s the way the Federal law
22 works , but that kind of doesn ' t make sense to me , as someone
23 who would want this to be medically reasonably based .
24 So t ho se are my comments and I think we should
25 I think we should postpone recommending this Rule for those
Integrity Legal Support Solutions APPENDIX B www . integrity - texas . com Audio Tra _ scription - 6/9/2015
19 1 rea s ons .
2 MS. VANHOOSE : Thank you for those comments .
3 I think one of our concerns is CMS has been
4 telling us these Rules are going to come out forever . So we
5 are very hopeful they do come out and when those Rules do
6 come out , we ' re going to have to look at all of our DME
7 Policies and Rules , so that makes sense .
8 But just to clarify, it ' s the process today . So
9 these Rules stuck in these Rules , the process is there .
10 We ' re going to have to work -- it ' s two - step -- another
11 two - step basically .
12 DR . HANDAL : Yes .
13 MS . VANHOOSE : This is the process today . With
14 our vendor there ' s contract agreements , requirements around
15 it , so stopping this Rule doesn ' t mean tomorrow that the
16 process isn ' t still taking place , but we ' ll have to go back
17 and look at the process , so .
18 MR . HELLERSTEDT : Another comment I would have --
19 agaln , correct me if I ' m wrong , but this is -- we're talking
20 about -- we ' re not talking about even managed care , so none
21 of this even applies to managed care .
22 MS . VANHOOSE : Right , correct . We've met with our
23 managed care staff , Gary ' s staff , to figure out how or what
24 should be taking place in the managed care side .
25 MS - TIEKEN : That gives me even more concern .
Integrity Legal Support Solutions APPENDIX B www . integrity- texas . com Audio Transcription - 6/9/2015
20 1 MS . VAN HOOSE : · Yeah .
2 DR. HANDAL : Wait. I mean , Gary wants to say
3 something .
4 MR. JESSEE: Well, I mean , I was just going to say
5 really what Laurie has already said and that is : It sounds
6 like , based on some of the testimony already today , th~t
7 people aren't happy with the current process .
8 And I know , Maureen , you talked about some of the
9 individuals that you ' v e represented .
10 So there is somet hing that needs to be done
11 because obviously there ' s a Rule in place we were trying to
12 make a little more clear . Of course , clarity is not alwa y s
13 the best thing .
14 But you know , as I was saying to Dr . Hellerstedt
15 here and I said to La uri e , I think if you give us an
16 opportunity to take a look at the proposed language, maybe
17 one of the solutions is the ability to request that sort of
18 information if there is some reason that nobody can get to
19 the place where it believes it's medically necessary . So
2 0 maybe the exception would be that sort of information , as
21 opposed to just right up front .
22 But I think we do need some time to visit
23 internally to figure out the best next step , but it ' s been
24 made v ery clear that what we ' re trying to propose as some
25 clarification , we need to do a little more work on , so .
Integrity Legal Support Solutions APPENDIX B www . integrity-texas . com Audio Transcription - 6/9/2015
21 1 DR . HANDAL : I need a motion to send it back .
2 MS . DEWALSH : ( Indiscernible ) .
3 DR . HANDAL : DeWalsh make the motion .
4 Second?
5 Mr . Smith?
6 MR . SMITH : What motion which motion· is that?
7 DR . HANDAL : The motion is to not accept the
8 publication , but send it back for further study .
9 MR . SMITH : Okay . I was going to table it , but if
10 we already have a motion.
11 DR . HANDAL : So all in favor?
12 MS . BIBBY : I move do you still need?
13 DR . HANDAL : Moved by DeWalsh , second by
14 Mr . Smith .
15 MS. BIBBY : Oh , okay .
16 DR . HANDAL : So all in favor , say " aye ."
17 ALL : Aye .
18 DR . HANDAL : We ' ll send it back and motion denied .
19 (End of partial transcript at 2 : 36p . m. )
25 * * * * *
Integrity Legal Support Solutions APPENDIX B www.integrity - texas . com Audio Transcription - 6 / 9/2015
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