Anda di halaman 1dari 31

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 1 of 31 PageID #:1

UNITED STATES DISTRICT COURT


FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
______________________________________________________________________________
JOYCE BOOKSHESTER,
Plaintiff,
v.

Case No. 16-9529

SYLVIA BURWELL in her official capacity


as Secretary, United States Department
of Health and Human Services,
Defendant.
COMPLAINT
______________________________________________________________________________
Plaintiff, Joyce Bookshester, by her undersigned counsel, brings this action for judicial
review of final agency decisions of Defendant Sylvia Burwell, in her official capacity as
Secretary of the United States Department of Health and Human Services, and states as follows:
OVERVIEW OF THE IMPORTANCE OF THE CASE
1.

This action arises under Title XVIII of the Social Security Act, 42 U.S.C. 1395

et seq. (the Medicare Act), and the Administrative Procedure Act (APA), 5 U.S.C. 551 et
seq. Plaintiff, Joyce Bookshester, seeks judicial review of a final decision of Defendant, the
Secretary (the Secretary) of the Department of Health and Human Services (HHS).
2.

This lawsuit is unfortunately necessary as one of a growing number of cases

arising out of the Secretarys refusal to approve Medicare coverage of a medical device and its
supplies for people with severe diabetic conditions. Although this device, a continuous glucose
monitor, is nationally and internationally recognized as the standard of care for individuals

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 2 of 31 PageID #:2

suffering from Type 1 diabetes who have lost the ability to detect drops in glucose, the Secretary
has denied coverage, thereby ignoring the consensus of medical experts, the peer-reviewed
literature, independent government assessments, the consensus of the payer community, and her
own rules and regulations. Joyce Bookshester is a PhD, and licensed clinical psychologist, with
serious diabetic conditions that over three decades have caused her body to lose the ability to
detect drops in glucose. In denying coverage for Dr. Bookshesters use of the continuous glucose
monitor (CGM) that is an FDA-approved device, the Secretary refused to consider the specifics
of Dr. Bookshesters brittle Type 1 diabetes and instead issued a categorical and arbitrary and
capricious conclusion, asserting in essence that any persons use of any continuous glucose
monitor is simply precautionary. Of note, the term precautionary is not used or defined in
the Act, and has not been turned into a term of art through regulations. The term instead was
invented through informal action, and its categorical use violates the Act and deprives Dr.
Bookshester of her rights under the Act.
3.

The Secretarys arbitrary and capricious decision refused to consider any part of

the extensive evidence presented below on the specifics of Dr. Bookshesters brittle Type 1
diabetes and resulting medical need for CGM. The status of CGM as the standard of medical
care for persons such as Dr. Bookshester is so well established that even a profit-driven private
insurer paid for the device and supplies at issue before Dr. Bookshester became Medicare
eligible. The Secretarys decision below also is contrary to the overwhelming evidence in the
extensive record below, which includes peer-reviewed medical and scientific articles and the
testimony of her treating physician, a nationally and internationally known University of
Chicago diabetes expert. The extensive evidence presented by Dr. Bookshester is undisputed and
uncontroverted.

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 3 of 31 PageID #:3

4.

The Secretarys decision below is even more arbitrary and capricious because the

Secretary was explicitly on notice that the document upon which the Secretarys decision relies
was (1) discredited by the Medicare component that evaluates Medicare coverage policies and
(2) at least two prior federal district court decisions explicitly holding that such reliance was
improper. See Whitcomb v. Burwell, 2015 U.S. Dist. LEXIS 67802 (May 26, 2015), and Finigan
v. Burwell, 2016 U.S. Dist. LEXIS 66125 (D. Mass. May 19, 2016)(agreeing with the reasoning
and outcome of Whitcomb). When disregarding the district court decisions, the Secretary,
through the Medicare Appeals Council, simply stated that the Burwell decision was not
binding because it was issued by a federal judge in Wisconsin rather than Illinois. This smallminded approach is yet another example of why the 7th Circuit has time and again reversed
administrative law decisions, with increasing numbers of opinions explicitly chastising
administrative decision-makers for nonsensical administrative processes and rulings that defy
common logic. See, e.g., Meuser v. Colvin, No. 16-1052, 2016 U.S. App. LEXIS 17823 (7th Cir.
Oct. 3, 2016)(per Judges Wood, Bauer and Kanne, reversing when the ALJ ignored relevant
facts, failed to credit the opinion of treating physician, failed to explore the specifics of an
opinion and failed to explain the weight given to the opinion); Herrmann v. Colvin, 772 F.3d
1110 (7th Cir. 2014)(per Judges Posner, Tinder and Bauer, strongly criticizing agency use of old,
unproven data, and describing the impropriety of an ALJ choosing not to credit a doctors
testimony simply because of a lack of detailed paper notes). See also Posner Opinion Takes Aim
at Denial of Disability Benefits; Is It a 7th Circuit Trend?1
5.

This case also is important because the proceedings below illustrate the extreme

and statute-breaching administrative delays that endanger the health of persons with serious
1

http://www.abajournal.com/news/article/posner_opinion_takes_aim_at_denial_of_disability_ben
efits_is_it_a_7th_circu/
3

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 4 of 31 PageID #:4

illness. Here, the Medicare Appeals Council failed to abide by the explicit statutory deadline for
issuing its decision, and then also refused to take the Congressionally mandated steps that would
have accelerated this Courts jurisdiction over this appeal, despite Dr. Bookshesters counsel
moving to exercise the right to move proceedings to this Court.2
6.

Overall, the administrative process below consumed two years and resulted in a

decision that is arbitrary and capricious and unsupported by substantial evidence. Two years is
far longer than an older, ill population should have to endure for resolution of a claim for lifesaving medical equipment. In view of the delays and errors below, and the broader implications
of this case, this Court should act decisively.
OVERVIEW OF CASE FACTS
7.

The Medicare Appeals Council decision at issue denied payment for supplies

necessary for a continuous glucose monitor (CGM), a device used by persons with brittle
diabetes, such as Dr. Bookshester. A copy of the decision is attached as Exhibit 1.
8.

The continuous glucose monitor used by Dr. Bookshester was prescribed by her

treating physician, a nationally and internationally known and well-published diabetes expert
(Dr. Louis Philipson), who practices medicine through the University of Chicago. Dr. Philipson
prescribed the continuous glucose monitor to enable Dr. Bookshester to manage her brittle Type
I diabetes.
9.

As was proven below, Dr. Bookshester has had diabetes for over 30 years and

now has what is known as brittle Type 1 diabetes, meaning she has large, erratic swings in her

During proceedings below, Dr. Bookshester was represented by Edward Kraus, a Clinical
Professor of Law at Chicago-Kent College of Law, through a legal clinic at the law school.
Beginning in September 2007, Professor Kraus focused part of his practice on representing and
advocating for persons with diabetes.
2

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 5 of 31 PageID #:5

glucose level which makes it difficult to control. To manage this dangerous condition, Dr.
Bookshester has used a CGM for over 3 years, and the device was recognized as reasonable and
medically necessary, and thus covered by her private insurer.
10.

Dr. Bookshesters brittle Type 1 diabetes is especially dangerous because her

glucose levels remain uncontrolled, i.e., brittle, despite consistently and conscientiously
following nutritional instructions, exercising regularly, performing frequent self-monitoring (6 or
more times daily), and following a comprehensive insulin administration regimen for her
diabetes.
11.

The substantial medical challenges caused by diabetes are compounded for Dr.

Bookshester because her body has lost the ability to detect its insulin falling to dangerously low
levels. The CGM recognizes the condition and enables her to take corrective action.
12.

These hypoglycemic events often occur while Dr. Bookshester is asleep. Such

hypoglycemic events lead to what is known among the diabetes community as dead in bed
syndrome, a phenomena in which one in twenty Type 1 diabetics dies in their sleep from an
undetected low glucose.
13.

CGMs are not exotic new or experimental devices. To the contrary, as proven

below, many years of studies and a large body of peer-reviewed science have proven the general
effectiveness of CGMs in managing diabetes. And, Dr. Bookshester testified to her personal and
successful use of a CGM for over three years as part of controlling her diabetes. CGMs have
been around many years and are the current standard of care. 3
14.

As the record below establishes, CGMs are FDA-approved devices that are

nationally and internationally considered the standard of care for Type 1 diabetes. Due to their
http://www.medtronicdiabetes.com/treatments/continuous-glucose-monitoring (last visited
October 3, 2016).
3

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 6 of 31 PageID #:6

current precision, the FDA recently approved a CGM system that automatically directs the
administration of insulin, and an FDA advisory panel recommended, that confirmatory
fingersticks be removed from the CGM label.4
15.

The vast majority of even profit-driven private insurance payers cover CGMs for

persons such as Dr. Bookshester. Moreover, during the ALJ hearing, Dr. Bookshester presented
expert and lay testimony that proved both 1) the general effectiveness of CGMs, and 2) Dr.
Bookshesters successful of the CGM to control glucose levels that vary dangerously due to her
brittle Type I diabetes, thus making the CGM an essential disease management tool for Dr.
Bookshester. Dr. Philipson, a nationally and internationally acknowledged diabetes expert, and
her treating physician for over a decade, also testified in support of Dr. Bookshesters need.
16.

The decision below also is contrary to Medicare regulations. Specifically, a

National Coverage Determination (NCD) is a determination that Medicare will in general pay
for a type of device or diagnostic that satisfies the Acts statutory standard of paying for items
that are medically necessary. NCD 40.2 specifically acknowledged that it is medically necessary
for persons with diabetes to monitor and control the levels of glucose in their bodies. To that end,
Medicares NCD 40.2 specifically covers devices and supplies that enable a person to monitor
and control glucose levels in the body. The NCD specifically applies to home blood glucose
monitoring systems. The NCD does not explicitly include or exclude CGMs, but reflects the
medical necessity and reasonableness of monitoring and controlling glucose levels.

See generally http://insulinnation.com/treatment/fda-panel-recommends-expanded-use-of-cgms/


(last visited October 3, 2016). The FDA Executive Summary for the AdComm meeting on
CGMs is online:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevi
ces/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/
UCM511810.pdf (last visited October 3, 2016).
4

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 7 of 31 PageID #:7

17.

The decision below also is improper when judged against a local coverage

decision. Specifically, the relevant Medicare contractor for Chicago (National Government
Services (NGS)) issued a local coverage determination (LCD) L27231, approving as
necessary and reasonable blood glucose monitors and related accessories and supplies. That
policy states that such expenses will be covered when (1) a patient has diabetes which is being
treated by a physician; (2) the patients physician states the patient is capable of using the device;
and (3) the device is designed for home use rather than clinical use. Again, the LCD does not
explicitly include CGMs, but reflects the medical necessity and reasonableness of monitoring
and controlling glucose levels.5
18.

Despite the foregoing, the Medicare Appeals Council denied coverage for Dr.

Bookshesters claim. In doing so, the AC (as it is known) improperly and unreasonably 1)
refused to consider Dr. Bookshesters medical condition, 2) refused to consider and apply the
Whitcomb decision, refused to consider and apply the Finigan decision, and refused to consider
and apply the ruling of Medicares Civil Remedies Division that explicitly found that an informal
document, an Article, was invalid under the reasonableness standard.
19.

The Whitcomb opinion specifically pointed out the same untenable flaw that

invalidates the Secretarys decision in this case. That flaw arises from the Secretary giving
controlling effect to one sentence lifted from an informal, non-binding policy statement known
as an Article. The informally-issued Article states that CGMs are considered precautionary,
and therefore not a covered Medicare benefit. However, the term precautionary is not used in
the Medicare Act and has not been developed into a term of art through formal regulations. The

https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=222&ncdver=2&NCAId=35&NcaName=Home+Blood+Glucose+Monitors
&IsPopup=y&bc=AAAAAAAAIAAA& (last visited October 3, 2016).
5

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 8 of 31 PageID #:8

Secretary refuses to acknowledge the reality that a CGM is precautionary for persons such as
Dr. Bookshester only to the extent it is precautionary to avoid death from uncontrolled diabetes.
As explained in the Whitcomb opinion:
Looking to Articles for coverage determinations would undermine Section 522 of
BIPA, whereby Congress created the right for certain beneficiaries to challenge
coverage language contained in LCDs. See 68 Fed. Reg. 63692, 63693. Given
their limited purpose, an Article is not subject to challenge. 42 C.F.R.
426.325(b)(9) [*10] . Reading an Article as if its language determined whether a
service or item is covered would render such determination exempt from review.
Moreover, Articles may be created without the notice and comment period
required for an LCD. See CMS Medicare Manual System, Pub. 100-8, Medicare
Program Integrity Manual, Chapter 13 Local Coverage Determinations,
13.7.2 LCDs That Require a Comment and Notice Period, available at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/
pim83c13.pdf (last visited May 26, 2015). Accepting the Secretary's position that
an Article can determine coverage would seemingly open the door to a system
whereby beneficiaries would not have the opportunity to provide input on
coverage determinations before the policy went into effect or to challenge those
policies once they were adopted.
Nor does an Article fall within the scope of "CMS program guidance" so as to
otherwise be entitled to substantial deference under 42 C.F.R. 405.1062(a).
Because NCD 40.2 and LCD L27231 do not reference continuous glucose
monitors, and because Article A47238 is not incorporated into LCD L27231, the
question is whether a continuous glucose monitor is reasonable and necessary for
Whitcomb and not otherwise excluded.
20.

For those and other reasons, the Secretarys decision to deny coverage of CGM

for Dr. Bookshester is arbitrary and capricious and not supported by substantial evidence.
Therefore, Plaintiff seeks an order reversing the coverage denials and instructing the Secretary to
pay the claim at issue in accordance with applicable law. The decision at issue is arbitrary and
capricious, not supported by the evidence or Medicare law, regulation or guidance, and is
inconsistent with and contrary to the facts, medical records and expert testimony below, and does
not conform to the medical standard of care. The actions also constitute an unconstitutional
8

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 9 of 31 PageID #:9

denial of due process and taking of rights because the Medicare Appeals Council precluded Dr.
Bookshester from exercising her constitutionally protected interests and rights under the
Medicare Act.
Parties
21.

Joyce Bookshester, PhD, is a Medicare beneficiary residing in the City of Chicago

who is seeking Medicare coverage of her claims for a CGM device and related accessories and
supplies.
22.

Dr. Bookshester has been a Medicare beneficiary since at least 2013.

23.

Plaintiff brings this action as an appeal of the Secretarys final decision denying

Medicare claims for the CGM and related supplies.


24.

Defendant Sylvia Burwell is the Secretary of HHS, the federal department that

contains the Centers for Medicare & Medicaid Services (CMS). The Secretary, the federal
official responsible for administering the Medicare Program, has delegated that responsibility to
various contractors.
Jurisdiction and Venue
25.

The Court has subject matter jurisdiction under 42 U.S.C. 405(g) and 1395ff(b)

(appeal of final Medicare program agency decision) and under 28 U.S.C. 1331 (federal
question) and 1361 (mandamus).
26.

Venue lies in this judicial district under 42 U.S.C. 405(g) and 1395ff(b) and 28

U.S.C. 1391(e).
Procedural Background
27.

The denial at issue in this action first arose when NGS denied claims for Dr.

Bookshesters supplies for her CGM.

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 10 of 31 PageID #:10

28.

Dr. Bookshester appealed these denials through the multi-step Medicare Part B

appeals process, ultimately filing a request for review with the Medicare Appeals Council
(sometimes, the AC) on May 12, 2015.
29.

The statute and Medicare regulations provide that the Medicare Appeals Council

should render a decision within 90 days of a request for review.


30.

Furthermore, if the Medicare Appeals Council does not render a decision within

90 days, an appellant can file an escalation request to District Court.


31.

Upon receipt of an escalation request, the AC is required to issue a decision

within five days, issue a remand, or provide notice that it cannot decide the case within the five
days so that an appellant can seek relief from the District Court.
32.

The escalation rules were invoked by Dr. Bookshester through her counsel, but

were disregarded by Medicare Appeals Council. Specifically, after the case had languished at
the Medicare Appeals Council for almost a year, Dr. Bookshester filed a request for escalation
on May 5, 2016. Despite the statutory and regulatory requirements that the Medicare Appeals
Council act within five days of receipt of an escalation request, the Medicare Appeals Council
did not issue a ruling within five days and repeatedly simply demurred, stating it was working
on it.
33.

After multiple requests by Dr. Bookshesters counsel, the Medicare Appeals

Council issued its denial decision on August 8, 2016.


34.

In its decision, the AC explicitly declined to embrace the reasoning of the ALJ,

but asserted new bases for denying the claim.

10

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 11 of 31 PageID #:11

35.

The exhaustion of the Medicare appeals process took over two years and has

resulted in an improper, inconsistent and unsupported decision by the AC, which is the
Secretarys final decision for purposes of judicial review.

A.

General Background of the Medicare Program

36.

The Medicare Act established a program of health insurance for the aged,

disabled, and individuals afflicted with end-stage renal disease. See 42 U.S.C. 1395 -1395ccc;
42 C.F.R. Parts 400 1004.
37.

Medicare is comprised of various parts, including Parts A through D. This

action arises under Part B (covering basic non-hospital medical needs).


38.

Under 42 U.S.C. 1395hh(a)(1), the Secretary is required to prescribe such

regulations as may be necessary to carry out the administration of the Medicare program. Such
regulations can be issued only after administrative processes designed and intended to result in
appropriate administrative decision-making.
39.

Section 1395hh(a)(2) of the Medicare Act limits regulatory decisions as follows:

No rule, requirement, or other statement of policy (other than a national coverage


determination) that establishes or changes a substantive legal standard governing
the scope of benefits, the payment for services, or the eligibility of individuals,
entities, or organizations to furnish or receive services or benefits under this title
shall take effect unless it is promulgated by the Secretary by regulation under
paragraph (1). U.S.C. 1395hh(a)(2).
40.

The Secretary has elected to publish many rules implementing the Medicare

program in various manuals, such as the Medicare Program Integrity Manual (MPIM) and the
Medicare Claims Processing Manual (sometimes, the MCPM). However, under 42 U.S.C.
1395hh(a)(2), these manual provisions, which are not promulgated in accordance with the
notice and comment provisions of the APA, are not effective to the extent that any of them

11

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 12 of 31 PageID #:12

establishes or changes a substantive legal standard governing the scope of benefits, the payment
for services, or the eligibility of individuals, entities, or organizations to furnish or receive
services or benefits under Medicare.

B.

Medicare Coverage and Payment of DMEPOS and Related Supplies

41.

The decision at issue wrongly denied coverage for supplies for Dr. Bookshesters

42.

Medicare Part B provides for coverage and payment for medical and other health

CGM.

services, which includes durable medical equipment prosthetics, orthotics and supplies
(sometimes, DMEPOS) provided to Medicare beneficiaries. See 42 U.S.C. 1395k(a) and
1395x(n) and (s).
43.

The intention and purpose of the Act is that Medicare shall pay for medical

devices - and related supplies that are reasonable and necessary for the diagnosis or treatment
of illness or injury or to improve the functioning of a malformed body member. See 42 U.S.C.
1395y(a).
44.

Durable medical equipment (sometimes, DME) is defined at 42 C.F.R.

414.202. Durable Medical Equipment (1) can withstand repeated use; (2) is primarily and
customarily used to serve a medical purpose; (3) is generally not useful to an individual in the
absence of an illness or injury; and (4) is appropriate for home use.
45.

The Medicare Claims Processing Manual, Ch. 15, 110.1(B)(2) reiterates these

requirements.
46.

There are many types of durable medical equipment prosthetics, orthotics and

supplies, a/k/a DMEPOS. They are categorized by CMS pursuant to the Healthcare Common

12

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 13 of 31 PageID #:13

Procedure Coding System (HCPCS) pursuant to an alpha-numeric code consisting of a letter


and a four-digit number. Some items of DMEPOS are assigned a unique HCPCS code. To obtain
a unique code, a medical device or supply must achieve sufficient volume, i.e., adoption within
the medical community. See
www.cms.hhs.gov/MedHCPCSGenInfo/Downloads/decisiontree.pdf.
47.

If Medicare covers a piece of DME, it also covers the supplies necessary for the

effective use of the DME.


48.

In this case, the Secretary denied coverage of the supplies used with a CGM that

is medically necessary and reasonable for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member. See 42 U.S.C. 1395y(a).
49.

Claims for Medicare payment for DMEPOS items supplied to Medicare

beneficiaries are presented to DME Medicare Administrative Contractors (DMACs). DMACs


adjudicate these claims as agents of the Secretary pursuant to contracts. The country is divided
into four geographic jurisdictions, each of which has its own DMAC. A DMEPOS supplier must
submit each of its claims to the DMAC having geographic jurisdiction for reimbursement of that
claim. See 42 C.F.R. 424.32.
50.

After a claim is submitted to the appropriate DMAC, the DMAC must determine

if the item is covered or otherwise reimbursable under the Medicare Act. See 42 C.F.R.
405.920. The DMAC responsible for Chicago area claims is known as National Government
Services (sometimes, NGS).

13

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 14 of 31 PageID #:14

C.

National Medicare Coverage Determinations and Glucose Monitoring

51.

A National Coverage Determination (sometimes, NCD) is a determination by

the Secretary of whether a particular item or service is covered nationally under Medicare. See
42 C.F.R. 405.1060(a)(1).
52.

A National Coverage Determination is binding on all Medicare contractors and

Medicares administrative law judges (ALJs), and the Medicare Appeals Council. See 42
C.F.R. 405.1060(a)(4).
53.

To ensure coverage of diabetic testing equipment and supplies, in 2006, the

Secretary issued the current effective version of the NCD providing Medicare coverage for blood
glucose monitors. See Medicare National Coverage Determinations Manual 40.2, Home Blood
Glucose Monitors (hereinafter NCD 40.2).
54.

Under NCD 40.2, a home blood glucose monitor is deemed medically necessary

and reasonable, and is therefore covered, when:


a. The patient has been diagnosed as having diabetes;
b. The patients physician states that that the patient is capable of being trained to
use the particular device prescribed in an appropriate manner; and
c.

The device is designed for home rather than clinical use. Id.

55.

The NCD does not distinguish between single use home glucose monitors or

56.

The NCD does not exclude coverage for CGMs.6

CGMs.

NCD 40.2 is part of a downloadable collection of NCDs published online by CMS at


https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/ncd103c1_Part1.pdf. The NCD also may be found in
online form, with historic notes, at https://www.cms.gov/medicare-coveragedatabase/details/ncd6

14

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 15 of 31 PageID #:15

D.

Local Coverage Determinations and Glucose Monitoring

57.

The decision below also refers to a local coverage determination (LCD). Local

Coverage Determinations are not binding on Medicare ALJs.


58.

DMACs such as National Government Services issue Local Coverage

Determinations after consideration of the peer-reviewed literature, consultation with the relevant
medical community, notice and comment. See Medicare Program Integrity Manual (MPIM)
Ch. 13, 13.7.
59.

When an ALJ is rendering a decision, the ALJ is not bound by a Local Coverage

Decision. However, an ALJ is to give deference to an LCD, if applicable. See 42 C.F.R.


405.1062. If an ALJ does not give deference to an LCD, the ALJ must explain why he or she
did not defer to the LCD.
60.

In 2008, National Government Services (NGS) issued LCD L27231 indicating

that devices to monitor glucose levels, and related accessories and supplies, are medically
necessary and reasonable, and are covered when (1) a patient had diabetes which was being
treated by a physician; (2) the patients physician states the patient is capable of using the device;
and (3) the device is designed for home use rather than clinical use.
61.

The NGS LCD did and does not indicate that a CGM was and is not a Medicare

covered benefit.
62.

The NGS LCD does not exclude coverage for CGMs.

63.

In contrast to NCDs and LCDs, Articles are informal communications issued by

MACs.

details.aspx?NCDId=222&ncdver=2&IsPopup=y&NCAId=35&NcaName=Home+Blood+Gluco
se+Monitors&bc=AAAAAAAAIAAA&.
15

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 16 of 31 PageID #:16

64.

Articles may be issued without consultation with the relevant medical community

or the peer reviewed literature. Articles also are not subject to challenge by providers or
beneficiaries. Accordingly, when coverage claims are being considered, Articles are not entitled
to any deference by either a QIC or an ALJ. See 42 C.F.R. 405.1062.
65.

Through the terms of the Act, Congress expressed its intent to enable diabetic

Medicare beneficiaries to manage and control their condition to reduce the complications from
the disease and costs (e.g. hospital and emergency room visits) to the Medicare program.

E.

The Process for Appeals of Medicare Claims Decisions

66.

Congress has established a five-step process for a Medicare beneficiary to follow,

which Dr. Bookshester has done, in order to obtain judicial review when dissatisfied with the
initial determination of a claim by the DMAC.
67.

Congress established this process to reduce the 368-day waiting time that

appellants had experienced when Medicare claims denials were heard by the Social Security
Administration.
68.

The first step in the process is request for redetermination by the DMAC. See 42

C.F.R. 405.940 through 405.958.


69.

Upon a request for redetermination, the DMAC is required to adjudicate a claim

and render a decision based on the evidence in the record. See 42 C.F.R. 405.954. Under 42
C.F.R. 405.956(b), the redetermination notice issued by the DMAC must include, inter alia, a
summary of the evidence used in making the redetermination; an explanation of relevant laws,

16

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 17 of 31 PageID #:17

regulations, coverage rules, CMS policies that apply to the case; and a summary of the rationale
for the redetermination in clear, understandable language. See 42 C.F.R. 405.956(b).
70.

A Medicare beneficiary who is dissatisfied with a DMACs redetermination

decision may request reconsideration by the DME qualified independent contractor (a QIC).
See 42 C.F.R. 405.960. The QIC is required to review the record of the claims and issue a
reconsideration decision having the same decision elements as the DMACs redetermination
decision. See 42 C.F.R. 405.976(b).
71.

A Medicare beneficiary may appeal the QIC reconsideration decision by

requesting a hearing before an Administrative Law Judge (ALJ). See 42 C.F.R. 405.1000.
72.

ALJs are bound to follow an NCD. See 42 C.F.R. 405.1060(a)(4).

73.

In contrast to an NCD, local coverage determinations (LCDs) issued by MACs,

including DMACs, are not binding on an ALJ. See 42 C.F.R. 405.1062(a).


74.

When the ALJ is rendering a decision, although not bound by an LCD, if an ALJ

applies an LCD, the ALJ must apply the LCD in place on the date the item or service was
provided. See 42 C.F.R. 405.1034.
75.

Articles, in contrast, are not entitled to any deference by either the QIC or ALJ.

See 42 C.F.R. 405.1062.


76.

Pursuant to the statute and Medicare regulations, an ALJ should render a decision

within 90 days of a request for an ALJ hearing. 42 U.S.C. 1395ff(d)(1)(a); 42 .C.F.R


405.1016(a).
77.

If an ALJ issues an unfavorable decision, a Medicare beneficiary may appeal the

decision to the Medicare Appeals Council (the AC).

17

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 18 of 31 PageID #:18

78.

An NCD is binding on the AC and the AC limits its review to the evidence

contained in the record before the ALJ. See 42 C.F.R 405.1122(a)(1).


79.

Pursuant to the statute and Medicare regulations, the AC is to render a decision

within 90 days of a request for AC review. See 42 U.S.C. 1395(d)(2)(a); 42 C.F.R.


405.1100(c).
80.

If the AC does not render a timely decision, a Medicare beneficiary can seek

escalation to district court. See 42 C.F.R. 405.1132(a).


81.

Pursuant to Medicare regulations, the AC must act within five days of receipt of a

request for escalation, either rendering a decision or acknowledging it cannot so that a


beneficiary can file a lawsuit in federal court to challenge the action or inaction. See 42 C.F.R.
405.1132(a).
82.

The ACs decision becomes the Secretarys decision and is the final agency

decision for purposes of judicial review. See 42 C.F.R. 405.1136(d).


83.

A Medicare beneficiary seeking judicial review of the Secretarys final decision

may file a complaint in the district court of the United States for the judicial district in which
the party resides or where such individual, institution, or agency has its principal place of
business. See 42 C.F.R. 405.1136; see also 42 U.S.C. 405(g) and 1395ff(b). Timely
judicial review is being sought for a decision rendered by the Secretary. See 42 C.F.R.
405.1130 and 405.1134.
E.

The Process for Challenging an LCD

84.

Medicare regulations also provide a mechanism for a Medicare beneficiary to file

a challenge against an LCD. See 42 C.F.R. 426.400 et seq.

18

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 19 of 31 PageID #:19

85.

The LCD challenge process is independent from the claims appeal process and is

conducted by an ALJ who is a member of the Civil Remedies Division of the Departmental
Appeals Board of the Department of Health and Human Services (the Board). See 42 C.F.R.
426.310.
86.

When a Medicare beneficiary files an LCD challenge, the relevant MAC is

required to produce any information that the MAC considered when drafting an LCD including,
scientific articles, technology assessments, clinical guideless and statements from clinical experts
(the LCD Record). See 42 C.F.R. 426.418.
87.

The ALJ reviews the evidence submitted by the MAC and applying the

reasonableness standard, determines whether the LCD Record is complete and adequate to
support the validity of the LCD. See 42 C.F.R. 426.425(c).
88.

If the ALJ determines the LCD is not valid under the reasonableness standards,

the MAC must provide individual consideration for the claim that gave rise to the LCD
challenge, and all subsequent claims for the same device or service, without using the LCD or
LCD provisions found to be invalid. See 42 C.F.R. 426.460(b)(1).
STATEMENT OF FACTS AND PRIOR PROCEEDINGS
A.

Continuous Glucose Monitoring and Brittle Type 1 Diabetes

89.

Unfortunately, despite consistently and conscientiously following nutritional

instructions, regularly exercising, performing frequent self-monitoring (six or more times daily),
and following a comprehensive insulin administration regimen for their diabetes, some
individuals with Type 1 diabetes still have uncontrolled glucose levels. Such individuals are
known as suffering from brittle Type 1 diabetes.

19

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 20 of 31 PageID #:20

90.

Some individuals with brittle Type 1 diabetes also suffer from hypoglycemic

unawareness, i.e., they are unaware of an impending, dangerous low drop in blood glucose. The
term autonomic neuropathy is used to describe this condition, and was the subject of expert
testimony below. Hypoglycemic unawareness may result in prolonged and profound exposure to
hypoglycemia, resulting in seizure, loss of consciousness and brain damage.
91.

Individuals suffering from brittle Type 1 diabetes often have frequent nighttime

hypoglycemic episodes, which cause a progressive loss of mental function.


92.

A CGM alerts an individual suffering from brittle Type 1 diabetes to both hypo-

and hyperglycemic episodes. Whether a person is sleeping or awake, such episodes can occur at
a frequency that would confound any attempt to manage through simple finger stick blood
glucose checks.
93.

A CGM operates by measuring glucose in the interstitial fluid under the skin. As

the name implies, the device continuously tracks with and reflects the glucose concentration in
the blood. Thus, a CGM allows a user to engage in the medical necessary and reasonable process
of monitoring and managing changes in glucose that may induce a coma or death.
94.

A CGM is a physician-prescribed, FDA-approved medical device.

95.

A CGM is used solely by individuals with diabetes to aid in the treatment of their

disease.
96.

Use of CGMs has been recognized as the standard of care for brittle Type 1

diabetics, both nationally and internationally.


97.

Medical consensus statements/guidelines reflecting CGM as the standard of care

for brittle Type 1 diabetics have been issued by the American Association of Clinical
Endocrinologists Consensus Panel on Continuous Glucose Monitoring (which has recommended

20

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 21 of 31 PageID #:21

CGM since at least 2007); the American Diabetes Association (which has included the CGM in
its recommendation since at least 2009); the Endocrine Society; the German Diabetes
Association (which reviews the favorable consensus statements of many European nations);
various French Endocrinology and Diabetic Societies; the European Society for Pediatric
Endocrinology, the Pediatric Endocrine Society and the International Society for Pediatric and
Adolescent Diabetes.
98.

The American Medical Association passed a resolution in support of CGM

coverage for Medicare beneficiaries.


99.

The consensus of medical opinion regarding the safety and effectiveness of CGM

for brittle Type 1 diabetes is supported by at least nine peer-reviewed publications reflecting
randomized, controlled clinical trials.
100.

Based on the consensus statements, peer-reviewed literature and widespread

acceptance of CGM for brittle Type 1diabetics, the vast majority of commercial insurers cover
CGM for persons with brittle Type 1 diabetes.
101.

An independent federally-funded technology assessment found CGM reasonable

and medically necessary for brittle Type I diabetes. See Agency for Healthcare Research and
Quality, Effective Health Care Program, Comparative Effectiveness Review Number 57,
Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness (July 2012) at
102-103, 105.7
B.

The Proceedings Below Relating to the Claims at Issue in this Action

The cited pages of the report are attached as Exhibit 2. The entire 309 page report is online at
https://effectivehealthcare.ahrq.gov/ehc/products/242/749/CER57_InsulinDelivery_FinalReport_20120703.pdf
7

21

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 22 of 31 PageID #:22

102.

This is an action for judicial review of the final administrative decision of the

Secretary with the AC Docket Number M-15-907 (issued August 8, 2016).


103.

Dr. Bookshester has had Type 1 diabetes for 30 years, and the disease is now

brittle.
104.

Despite frequent testing, she was unable to gain control of her brittle Type 1

diabetes. She also suffers from hypoglycemia and hypoglycemic unawareness (also known as
autonomic neuropathy).
105.

Accordingly, her healthcare provider prescribed her a continuous glucose

monitor, which checks Dr. Bookshesters glucose approximately 288 times a day and alerts her
when she is experiencing a hypoglycemic event.
106.

For over a decade, Dr. Bookshesters healthcare provider has been a nationally

and internationally known expert in diabetes, Dr. Louis Philipson.


107.

During the proceedings below, Dr. Philipson testified that CGM was and is

reasonable and medically necessary for Dr. Bookshester.


108.

With CGM, Dr. Bookshester has had significant clinical improvement of her

blood glucose level control.


109.

Dr. Bookshester filed a claim for the CGM supplies, which were denied by NGS.

110.

Dr. Bookshester appealed the denial through the Medicare administrative appeal

process.
111.

On September 17, 2014, the Office of Medicare Hearings and Appeals received

Dr. Bookshesters request for an ALJ hearing.


112.

An ALJ hearing was conducted on March 10, 2015, 2016 before ALJ Knapp.

22

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 23 of 31 PageID #:23

113.

During the October hearing, Dr. Bookshesters healthcare provider, Dr. Louis

Philipson, testified that CGM was not precautionary but was medically necessary and reasonable
for Dr. Bookshester to control her diabetes.
114.

Dr. Philipson explained that Dr. Bookshesters medical need for CGM is extreme.

115.

Dr. Philipson noted that CGM prevents hypoglycemic and hyperglycemic events

and premature death.


116.

Although Medicare ALJs may retain a clinical and scientific expert to facilitate

their understanding of the case, the ALJ did not retain such an expert in this case.
117.

Although the statute and Medicare regulations provide that a decision should be

rendered in 90 days, it was not until April 28, 2015, that ALJ Knapp rendered an unfavorable
decision finding that CGM sensors are not covered by Medicare, 223 days after Dr.
Bookshesters request, far in excess of the statutory time period.
118.

On May 12, 2015, within the prescribed statutory time period, Dr. Bookshester

appealed the unfavorable ALJ decision to the AC.


Other Proceedings Involving CGMs
119.

Meanwhile, in December 2014, another Medicare beneficiary filed a challenge to

the provision in the NGS Article that asserted CGM was precautionary. See CR4596, In Re
Local Coverage Determination Complaint: Glucose Monitors (April 29, 2016). The challenge
was filed with the Department of Health and Human Services Departmental Appeals Board Civil
Remedies Division.
120.

In response to the challenge, neither CMS nor NGS produced a single peer-

reviewed article or the opinion of a single medical expert in support of the articles assertion that

23

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 24 of 31 PageID #:24

CGM was precautionary. The Medicare beneficiary proffered numerous witnesses and
documents in support of her challenge.
121.

On April 26, 2016, the HHS Civil Remedies Division found that the assertion in

Article A47238 that CGM was precautionary and therefore not DME was invalid under the
reasonableness standard.8
122.

Specifically, the Civil Remedies Division Judge found that CGM met the

statutory definition of DME. The judge ruled:


The contractor and CMS have not produced any record in the form of peer-reviewed
literature, medical opinion, or even any analysis from an individual with a medical
background that supports a conclusion that CGM is never reasonable and necessary
regardless of the beneficiarys condition....[T]here are no findings of fact, interpretations
of law, and applications of law to fact by the contractor or CMS that are required to be
given deference or that may be found reasonable.
Request for Escalation of Dr. Bookshesters Appeal
123.

On May 5, 2016, after the CRD decision referred to above, and after Dr.

Bookshesters case had been pending at the AC for almost a year, i.e., long after the 90 day
period prescribed by statute and Medicare regulations, Dr. Bookshester filed a request for
escalation to federal district court.
124.

Although the statute and Medicare regulations require the AC to act within five

days of a request for escalation to district court, and the AC has repeatedly publicly
acknowledged its obligation, the AC took none of the required actions. See 42 U.S.C.
1395ff(d)(2)(A); 42 C.F.R. 405.1132.

The decision is online at https://www.hhs.gov/dab/decisions/civildecisions/2016/cr4596.pdf. A


copy is attached as Exhibit 3.
8

24

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 25 of 31 PageID #:25

125.

On August 8, 2016, after her case had been pending at the AC for more than 450

days, the AC affirmed the ALJs denial of Medicare coverage of CGM, although it declined to
follow the ruling of the ALJ and asserted other bases for denial.
126.

Without support, and ignoring the CRDs explicit findings, and other ruling on the

issues, the AC found that the CGM, and therefore its supplies, is simply precautionary, does not
serve a medical function, and therefore is not covered under the DME Medicare benefit.
127.

The Secretary has failed one her most vulnerable populations, Medicare

beneficiaries, by rendering decisions that clearly violate the statutory and regulatory timelines;
are contrary to the overwhelming medical and scientific evidence; and are contrary to her own
determinations regarding the evidence supporting CGM.
128.

The Secretarys delays in resolving this issue, and failing to consider the

overwhelming evidence, have placed Dr. Bookshester, and other similarly situated Medicare
beneficiaries, in a precarious medical state.
COUNT I
The Secretarys Decision is Arbitrary and Capricious and
Not Supported by Substantial Evidence
(CGM is Not Precautionary and Not Excluded from Coverage)
129.

Plaintiff hereby incorporates by reference paragraphs 1 to XXX herein.

130.

Under the Medicare statute, 42 U.S.C. 1395ff(b), the final agency decision

included in this action is subject to judicial review under the applicable provisions of the APA.
Under the APA, the reviewing court shall set aside the final agency decision if, inter alia, it is
contrary to law, arbitrary and capricious, an abuse of discretion, or unsupported by substantial
evidence in the record.

25

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 26 of 31 PageID #:26

131.

To the extent that the Secretarys decision in this action found that CGM is

precautionary and therefore not reasonable and medically necessary, the Secretarys decision
must be set aside because it is contrary to law, arbitrary, capricious, and unsupported by
substantial evidence in the record.
132.

CGM is reasonable and medically necessary for brittle diabetics as widely

recognized.
133.

Based on the foregoing, the Secretarys decision that the CGM is not covered

because it is precautionary, is contrary to Medicare regulations, arbitrary and capricious, and


unsupported by substantial evidence in the record, and Plaintiff asks the Court to reverse the
Secretarys decisions and issue an order finding that the CGM is not precautionary and is
reasonable and medically necessary, and direct the Secretary to make appropriate payment for
the device.
COUNT II
GCMs are Medically Necessary for Dr. Bookshester and Others; the Secretarys Decision
is Arbitrary and Capricious and Not Supported by Substantial Evidence
(CGM is Covered Under NCD 40.2)
134.

Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

135.

The Secretarys decision in this action must be set aside because it is arbitrary,

capricious, and unsupported by substantial evidence in the record. For some persons, including
Dr. Bookshester, CGM is reasonable and medically necessary.
136.

The finding that CGM is per se precautionary for all persons is not supported by

the record and is contrary to the evidence, which includes numerous peer-reviewed studies,
professional society statements, testimony by and opinions of expert and/or practicing
physicians, and NCD 40.2.

26

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 27 of 31 PageID #:27

137.

Based on the foregoing, Plaintiff asks the Court to reverse the Secretarys

decision and issue an order finding that the CGM and related supplies are reasonable and
medically necessary for Dr. Bookshester under NCD 40.2.
COUNT III
(Failure to Follow the NCD)
138.

Plaintiff hereby incorporates by reference paragraphs 1 to136 herein.

139.

To the extent that the Secretarys decision is premised on its failure to apply the

NCD 40.2, the Secretarys decision must be set aside because it is contrary to law, arbitrary and
capricious and without observance of procedure required by law. 42 C.F.R. 405.1060(a)(4).
COUNT IV
(CGM is Not Non-Covered Under LCD L27231)
140.

Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

141.

The Secretarys decision in this action must be set aside because it is arbitrary,

capricious, and unsupported by substantial evidence in the record. The finding that CGM is
precautionary is not supported by the record and is contrary to the evidence, which includes
numerous peer-reviewed studies, professional society statements and testimony by and opinions
of expert and practicing physicians.
142.

Based on the foregoing, Plaintiff asks the Court to reverse the Secretarys

decision and issue an order finding that the CGM is reasonable and medically necessary under
LCD L11530.
COUNT V
(Failure to Follow the LCD)
143.

Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

27

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 28 of 31 PageID #:28

144.

To the extent that the Secretarys decision is premised on its failure to apply the

LCD L27231, the Secretarys decision must be set aside because it is contrary to law, arbitrary
and capricious and without observance of procedure required by law. 42 C.F.R.
405.1060(a)(4).
145.

Based on the foregoing, Plaintiff asks the Court to reverse the Secretarys

decision and issue an order finding that the CGM is reasonable and medically necessary under
LCD L27231 and directing the Secretary to follow LCD L27231.
COUNT VI
(Improper and Unconstitutional Deference to the Article)
146.

Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

147.

To the extent that the Secretarys decision is premised on giving deference to an

NGS Article, which is not an LCD and is not entitled to deference, the Secretarys decision must
be set aside because it is contrary to law, regulation and arbitrary and capricious, and without
observance of procedure required by law.
148.

The Secretary provided no basis for refusing to give deference to the LCD, or

acknowledging that even if the Article applied, it should not be given deference in view of Dr.
Bookshesters uncontested dire need for CGM to avoid life-endangering glucose swings.
149.

The Secretary provided no basis for applying the Article, which has been found,

not supported by sufficient clinical and scientific evidence.


150.

The Secretarys actions also constitute an unconstitutional denial of due process

and taking of rights because the AC prevented Dr. Bookshester from exercising her
constitutionally protected interests under the Medicare Act. Cases arising under the 14th and 5th
Amendments establish that due process protects the right to enforce statutory terms free from

28

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 29 of 31 PageID #:29

arbitrary and capricious actions that defeat the exercise of statutory rights. See, e.g., Logan v.
Zimmerman Brush Co., 455 U.S. 422, 102 S. Ct. 1148 (1982).

COUNT VII
(Failure to follow the Statutory Definition of DME)
151.

Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

152.

To the extent that the Secretarys decision is premised on CGM not meeting the

statutory definition of DME, the Secretarys decision must be set aside because it is contrary to
law, regulation, her own manual provisions, is arbitrary and capricious, and without observance
of procedure required by law.
153.

The Secretary provided no basis for refusing to apply the statutory definition of

DME as set forth in her manual provisions that further articulate her interpretation of the
statutory provisions and is contrary to law and regulation and is arbitrary and capricious.
154.

The Secretarys actions also constitute an unconstitutional denial of due process

and taking of rights because the decision blocked Dr. Bookshester from exercising her
constitutionally protected interests in utilizing and enforcing her rights under the Medicare Act.
Cases arising under the 14th and 5th Amendments establish that due process protects the right to
enforce statutory terms free from arbitrary and capricious actions that defeat the exercise of
statutory rights. See, e.g., Logan v. Zimmerman Brush Co., 455 U.S. 422, 102 S. Ct. 1148 (1982).

COUNT VIII
Relief Under the Mandamus Act 28 U.S.C. 1361
155. Plaintiff hereby incorporates by reference paragraphs 1 to 136 herein.

29

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 30 of 31 PageID #:30

156. The Mandamus Act, 28 U.S.C. 1361 vests district courts with original
jurisdiction over any action in the nature of mandamus to compel an officer or employee of the
United States or any agency thereof to perform a duty owed to a plaintiff.
157. Under Federal law, HHS has a clear, non-discretionary duty to conduct and
conclude a hearing on a decision of a qualified independent contract . . . and render a decision on
such a hearing by not later than the end of the 90-day period beginning on the date a request for a
hearing has been timely filed. 42 U.S.C. 1395ff(d)(1)(A).
158. Under Federal law, HHS has a clear, non-discretionary duty for the AC to render
a decision within 90-days of a request for review. 42 U.S.C. 1395ff(d)(2)(A).
159. Absent mandamus, Medicare beneficiaries such as Dr. Bookshester have no
adequate remedy.
Requested Relief
WHEREFORE, Plaintiff requests:
1. An order setting aside the Secretarys decision that CGM and related supplies are not
covered under Medicare;
2. An order declaring CGM and related supplies are eligible for Medicare coverage;
3. An order remanding this action to the Secretary with instruction to cover Dr.
Bookshesters CGM and related supplies;
4. An order that this Court will retain jurisdiction over the decisions at issue until the
Secretarys payment of the claims at issue has been completed;
5. A declaratory judgment that the Secretarys delay in adjudicating Medicare appeals
violates Federal law;
6. An order awarding legal fees and costs of suit incurred by Plaintiff; and

30

Case: 1:16-cv-09529 Document #: 1 Filed: 10/06/16 Page 31 of 31 PageID #:31

7. Such other relief as this Court may deem and consider appropriate.
Date: October 6, 2016

Respectfully submitted,
Attorney for Plaintiff
/s/ Kirk T. Hartley
LSP Group LLC Law Science Policy
Kirk T. Hartley
Bar Registration - 6185510
445 West Erie Street
Suite 102
Chicago, IL 60654
Tel: 312-857-5545
Email: khartley@lspgrp.com

31