Whitcomb v. United Healthcare of Wisconsin/Secure Horizons

Filing 51

DECISION AND ORDER signed by Magistrate Judge William E Duffin. IT IS THEREFORE ORDERED that this matter is remanded to the Secretary for further proceedings in accordance with this decision. (cc: all counsel)(asc)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
JILL A. WHITCOMB,
Plaintiff,
v.

Case No. 13-CV-990

SYLVIA MATHEWS BURWELL,
Defendant.
DECISION AND ORDER
This action comes before the court for review of the Secretary of Health and
Human Services’s final decision denying coverage for a continuous glucose monitor for
plaintiff Jill Whitcomb. All parties have consented to the full jurisdiction of a magistrate
judge. (ECF Nos. 42, 43.) The court has subject matter jurisdiction and venue is proper
under 42 U.S.C. §§ 405(g) and 1395ff(b).
I.

Standard of Review

Judicial review of a final decision of the Secretary of Health and Human Services
proceeds in accordance with 42 U.S.C. § 405(g), see 42 U.S.C. § 1395ff(b), in the same
manner as the court reviews a final decision of the Commissioner of the Social Security
Administration. Heckler v. Ringer, 466 U.S. 602, 605 (1984). The factual findings of the

Secretary are conclusive if supported by substantial evidence. 42 C.F.R. § 405.1136(f).
Legal questions are reviewed only to determine whether the Secretary complied with
the law and whether that law is valid. Wood v. Thompson, 246 F.3d 1026, 1029 (7th Cir.
2001) (quoting Johnson v. Heckler, 741 F.2d 948, 952 (7th Cir. 1984)). In assessing whether
the Secretary complied with the law, the court affords deference to the Secretary’s
construction of the agency’s own regulations or its governing statutes. Thomas Jefferson
Univ. v. Shalala, 512 U.S. 504, 512 (1994); Wood, 246 F.3d at 1030 (citing Chevron U.S.A.,
Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842 (1984)).
II.

General Background of the Medicare Program

Medicare is a defined benefit program, 64 Fed. Reg. 22619, 22620, that generally
precludes coverage for items or services that “are not reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the functioning of a malformed
body member.” 42 U.S.C. § 1395y(a)(1)(A). The Secretary administers the Medicare
program through the Centers for Medicare & Medicaid Services (CMS) and is vested
with authority to decide whether an item or service is “reasonable and necessary” or is
otherwise covered under one of the broad coverage categories under the Medicare Act,
64 Fed. Reg. 22619, 22620. CMS contracts out many administrative functions, including
payment, to private organizations, called Medicare Administrative Contractors (MACs).
A National Coverage Determination (NCD) is “a determination by the Secretary
that a particular item or service is covered nationally by Medicare.” 42 C.F.R.

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§ 405.1060(a)(1). An MAC may, by way of a Local Coverage Determination (LCD), make
its own determination as to whether an item or service is reasonable and necessary—
and, therefore, covered by Medicare. See 42 U.S.C. § 1395ff(f)(2)(B). However, an LCD
may not conflict with an NCD. Such a determination is binding throughout that
contractor’s jurisdiction. Almy v. Sebelius, 749 F. Supp. 2d 315, 320 (D. Md. 2010) (citing
42 U.S.C. § 1395ff(f)(2)(B)).
Prior to the Benefits Improvement and Protection Act of 2000 (BIPA), Pub. L. 106554, the information now contained in LCDs was contained in Local Medical Review
Policies (LMRPs). In addition to information as to whether an item or service was
covered by Medicare, LMRPs could contain non-coverage information, such as the code
that should be used to bill for a service or item and what payment was associated with a
particular service or item. BIPA replaced LMRPs with LCDs. See 67 Fed. Reg. 54534,
54536. LCDs contain information only as to whether an item or service is reasonable and
necessary and, therefore, covered by Medicare. Id. Following BIPA, payment and coding
information is now set forth in Policy Articles (Articles). Thus,
[a] local policy may consist of two separate, though closely related
documents: the LCD and an associated article. The LCD only contains
reasonable and necessary language. Any non-reasonable and necessary
language a Medicare contractor wishes to communicate to providers may
be done through the article. At the end of an LCD that has an associated
article, there is a link to the related article and vice versa.
Centers for Medicare and Medicaid Services, http://www.cms.gov/medicare-coveragedatabase/ (last visited May 26, 2015); see also CMS Medicare Manual System, Pub. 100-8,
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Medicare Program Integrity Manual, Chapter 3 - Verifying Potential Errors and Taking
Corrective Actions, § 3.3.2.8 – MAC Articles, available at

http://www.cms.gov/

Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c03.pdf) (last visited
May 26, 2015). Absent a published determination regarding whether a certain item or
service is covered by Medicare, coverage “decisions are made based on the individual’s
particular factual situation,” 68 Fed. Reg. 63692, 63693 (citing Heckler v. Ringer, 466 U.S.
602, 617 (1984)), and whether the item or service is reasonable and necessary, Almy, 749
F. Supp. 2d at 320.
Coverage determinations set forth in an NCD or LCD may be challenged in
accordance with 42 U.S.C. § 1395ff(f). See also 42 C.F.R. Part 426. Whitcomb did not
pursue this path. (Tr. 28.) Instead, this action comes before the court under 42 U.S.C.
§ 1395ff(b) pursuant to which the issue is the propriety of the Secretary’s decision in
Whitcomb’s particular case.
III.

Glucose Monitors

Glucose monitors covered by Medicare are discussed in NCD 40.2, which states
in part:
Blood glucose monitors are meter devices that read color changes
produced on specially treated reagent strips by glucose concentrations in
the patient’s blood. The patient, using a disposable sterile lancet, draws a
drop of blood, places it on a reagent strip and, following instructions
which may vary with the device used, inserts it into the device to obtain a
reading. Lancets, reagent strips, and other supplies necessary for the
proper functioning of the device are also covered for patients whom the
device is indicated. Home blood glucose monitors enable certain patients
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to better control their blood glucose levels by frequently checking and
appropriately contacting their attending physician for advice and
treatment.
In addition to NCD 40.2, applicable to this case there is a Local Coverage Decision that
addresses glucose monitors. Like NCD 40.2, LCD L27231 focuses on metered blood
glucose monitors that require a beneficiary to place a blood sample on a reagent strip
before placing it into the monitoring device to be read.
IV. Whitcomb Seeks Coverage for a Continuous Glucose Monitor
Whitcomb is an enrollee of United Healthcare of Wisconsin/Secure Horizons’s
Medicare Advantage plan. (Tr. 5.) For the past 35 years, Whitcomb has suffered from
type 1 diabetes. (Tr. 144, 146.) Due to the nature of her symptoms, the nurse practitioner
primarily responsible for providing care for Whitcomb regarding the management of
her diabetes prescribed a continuous glucose monitor for Whitcomb. (Tr. 830-37.) A
continuous glucose monitor is a sensor system that is designed to continuously and
automatically monitor interstitial glucose values in subcutaneous tissue. (Tr. 830-34.)
After a successful six-month trial period with the monitor (Tr. 281-98), Whitcomb
requested that United provide coverage for a continuous glucose monitor (Tr. 47).
United denied her request, citing Article A47238, which states “Continuous
glucose monitors…are considered precautionary and therefore non-covered under the
DME benefit.” (Tr. 56.) That conclusion was affirmed by United upon further review
(Tr. 266-67) and by a qualified independent contractor (Tr. 196-97). Whitcomb requested
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a hearing before an administrative law judge (ALJ), and a hearing was held on January
17, 2013. (Tr. 816-57.) On February 6, 2013, the ALJ issued a decision fully favorable to
Whitcomb, concluding that a continuous glucose monitor was covered under NCD 40.2
and LCD L27231. (Tr. 68-78.) United appealed and on August 25, 2013, the Medicare
Appeals Council reversed the ALJ’s decision. (Tr. 18-29.) The Council concluded that
the NCD referred to only blood glucose monitors that determine blood glucose reading
after a beneficiary draws a drop of blood from the finger with a sterile lancet, places it
on a specially treated reagent strip, and inserts the strip into the blood glucose monitor
for the reading. (Tr. 27.) The LCD, the Council concluded, incorporates Article A47238,
which unambiguously states that continuous glucose monitors are not covered by
Medicare. (Tr. 27.) The present action followed.
V. Analysis
The parties agree that NCD 40.2 and LCD L27231 do not explicitly refer to
continuous glucose monitors. But they disagree as to the meaning of that silence.
Whitcomb contends that NCD 40.2 and LCD L27231 discuss glucose monitors generally
and, thus, necessarily include continuous glucose monitors. (ECF No. 48 at 19.) The
Secretary argues that NCD 40.2 and LCD L27231 are limited to metered glucose
monitors that require a beneficiary to place a blood sample on a reagent strip before
placing it into the monitoring device to be read, and the lack of any reference to a

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continuous glucose monitor means that such a monitor is not covered. (ECF No. 49 at 56.)
NCD 40.2 defines blood glucose monitors as “meter devices that read color
changes produced on specially treated reagent strips by glucose concentrations in the
patient’s blood.” LCD L27231 is not as explicit, but read in its entirety, the LCD is
plainly focused upon a glucose monitor that involves a skin-piercing lancet to obtain a
blood sample that is collected on a test strip. The Medicare Appeals Council was correct
when it concluded that NCD 40.2 and LCD L27231 do not refer to or include continuous
glucose monitors. (Tr. 27.)
However, the Secretary, through the Medicare Appeals Council, erred when it
concluded that A47238 is incorporated into LCD L27231. Nothing in LCD L27231
attempts to incorporate A47238. The only connection between LCD L27231 and Article
A47238 is that A47238 is listed under the “Related Documents” section of LCD L27231
(Tr. 586) and vice-versa (Tr. 593).
A policy article is distinct from an LCD. LCDs speak to the issue of whether a
particular item or service is reasonable or necessary and therefore covered by Medicare.
42 U.S.C. § 1395ff(f)(2)(B); 67 Fed. Reg. 54534, 54536. Articles do not; their purpose is to
address non-coverage information, like coding and payment. See CMS Medicare
Manual System, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13 – Local
Coverage Determinations, § 13.1.3 - Local Coverage Determinations (LCDs), available at

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http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83
c13.pdf (last visited May 26, 2015). Presumably, when the preceding LMRP was
converted into LCD L27231 and Article A47238, the relevant language explicitly
excluding coverage for continuous glucose monitors could have been included in the
LCD rather than the Article, or the LCD could have been amended at any subsequent
point (the preceding LMRP does not appear to have been included as part of the record
and therefore the court cannot be sure whether it addressed continuous glucose
monitors at all). If the reference to the continuous glucose monitors contained in the
Article had been included in the LCD, the outcome of this case likely would be
different. But the fact that the LCD is silent as to whether continuous glucose monitors
are covered is not a matter the court can overlook.
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). 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

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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.
The Secretary never undertook that analysis. Thus the court concludes that
remand in accordance with 42 U.S.C. § 1395ff(b)(1)(A) and Sentence Four of 42 U.S.C.
§ 405(g) is necessary to permit the Secretary to assess this case under the proper legal
standard. Finally, because this matter comes before the court based upon a request for
pre-service authorization (Tr. 24), the court finds that 42 U.S.C. § 1395pp does not apply.

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IT IS THEREFORE ORDERED that this matter is remanded to the Secretary for
further proceedings in accordance with this decision. The Clerk shall enter judgment
accordingly.
Dated at Milwaukee, Wisconsin this 26th day of May, 2015.

_________________________
WILLIAM E. DUFFIN
U.S. Magistrate Judge

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