Baker v. Banner Health et al

Filing 56

ORDER granting 51 Bakers Early Motion for Partial Summary Judgment, by Judge William J. Martinez on 5/27/2015.(evana, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Judge William J. Martínez
Civil Action No. 12-cv-3029-WJM-CBS
MARTHA L. BAKER,
Plaintiff-Relator,
v.
BANNER HEALTH, and
BANNER MEDICAL GROUP COLORADO,
Defendants.

ORDER GRANTING PLAINTIFF’S EARLY MOTION FOR PARTIAL
SUMMARY JUDGMENT

Acting on her own behalf and on behalf of the United States, Plaintiff-Relator
Martha L. Baker (“Baker”) brings this lawsuit against Banner Health and Banner Medical
Group Colorado (together, “Banner”) for violation of the False Claims Act, 31 U.S.C.
§§ 3729–3733. (ECF No. 38.) Before the Court is Baker’s Early Motion for Partial
Summary Judgment. (ECF No. 51.) For the reasons stated below, the motion is
granted.
I. LEGAL STANDARD
Summary judgment is warranted under Federal Rule of Civil Procedure 56 “if the
movant shows that there is no genuine dispute as to any material fact and the movant
is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see also Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248–50 (1986). A fact is “material” if, under the
relevant substantive law, it is essential to proper disposition of the claim. Wright v.
Abbott Labs., Inc., 259 F.3d 1226, 1231–32 (10th Cir. 2001). An issue is “g enuine” if

the evidence is such that it might lead a reasonable trier of fact to return a verdict for
the nonmoving party. Allen v. Muskogee, 119 F.3d 837, 839 (10th Cir. 1997).
In analyzing a motion for summary judgment, a court must view the evidence
and all reasonable inferences therefrom in the light most favorable to the nonmoving
party. Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 670 (10th Cir. 1998) (citing
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986)). In
addition, the Court must resolve factual ambiguities against the moving party, thus
favoring the right to a trial. See Houston v. Nat’l Gen. Ins. Co., 817 F.2d 83, 85 (10th
Cir. 1987).
II. FACTS
The relevant facts are minimal and undisputed. Banner operates certain m edical
facilities in Colorado, including North Colorado Medical Center, McKee Medical Center,
and Sterling Regional MedCenter (collectively, the “Facilities”). (Movant’s Statement of
Material Facts (“Plaintiff’s Facts”) (ECF No. 51 at 2–11) ¶ 1.) Among other things, the
Facilities provide “external beam radiation therapy,” such as for treating cancer patients.
(Id. ¶ 2.) Banner has submitted Medicare claims for external beam radiation therapy
performed at the Facilities. (Id. ¶ 3.) In 2010, 2011, and 2012, Banner som etimes
performed external beam radiation therapy at the Facilities without the physical
presence of a medical practitioner authorized to prescribe such therapy. (Id. ¶¶ 24–25.)
III. ANALYSIS
A.

Propriety of Early Summary Judgment
As discussed in more detail below, Baker’s theory of liability is that, to obtain

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Medicare reimbursement, Medicare regulations (as applied in Colorado) require a
physician with specialized training in radiation therapy to be physically present in any
facility where external beam radiation therapy is taking place. (ECF No. 51 at 1.)
Because Banner at times did not have such a physician present, but nonetheless billed
Medicare for the procedure, Baker claims that Banner has submitted false claims,
potentially compensable under the False Claims Act. (Id.)
The undersigned’s practice standards normally limit parties to one motion for
summary judgment “customarily filed at the conclusion of pretrial discovery. In addition,
however, within 30 days after entry of the initial scheduling order, a party may also file
one early motion for partial summary judgment . . . which presents a substantial and
well-supported argument for significantly reducing the claims or issues in the case.”
WJM Revised Practice Standards III.E.2. Baker moves under this authority, arguing
that “[a]n early ruling on [the proper interpretation of the relevant Medicare regulations]
will significantly clarify and reduce the issues remaining in this case.” (ECF No. 51 at
1–2.)
The Court is persuaded that early summary judgment is appropriate on this
question. Baker’s entire claim hangs on whether she correctly reads certain Medicare
regulations and related Colorado regulations regarding radiation therapy. This appears
to be a pure question of law, and is not speculative. Although Banner denies that a
specially trained physician is required to be physically present in the facility where
radiation therapy is ongoing, Banner admits that it performed radiation therapy at the
Facilities without the physical presence of such a physician. (Response to Movant’s
Material Facts (“Defendants’ Response”) (ECF No. 52 at 4–6) ¶¶ 24–25.)
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One thing the parties’ competing statements of fact do not directly address is
whether Banner billed Medicare for any of those particular instances of radiation
therapy. Nonetheless, that accusation is implicit in Baker’s entire claim, and Banner
offers nothing to refute it. Rather, Banner offers additional facts regarding its specific
consideration of whether it could provide Medicare-reimbursable radiation therapy in the
absence of a specialized physician, and its conclusion that it could, so long as an
advanced practice nurse supervised the procedure. (Additional Material Facts
(“Defendants’ Additional Facts”) (ECF No. 52 at 6–11) ¶¶ 20–24.)
Given this, it appears that Banner indeed subm itted Medicare claims for radiation
therapy performed in the absence of the specialized physician that Baker claims must
be present. If Baker is correct, it would significantly clarify Banner’s potential liability. If
Banner is correct, it would apparently eviscerate Baker’s case. Accordingly, the Court
will rule on the issue presented, even though presented early.
B.

“Services That They May Personally Furnish in Accordance with State
Law”
This case turns largely on the meaning of 42 C.F.R. § 410.27, which is lengthy

but reads in relevant part as follows:
(a) Medicare Part B pays for therapeutic hospital or CAH [1]
services and supplies furnished incident to a physician’s or
nonphysician practitioner’s service, which are defined as all
services and supplies furnished to hospital or CAH
outpatients that are not diagnostic services and that aid the
physician or nonphysician practitioner in the treatment of the
patient, including drugs and biologicals which are not usually
self-administered, if—

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“CAH” means “critical access hospital” and generally refers to rural hospitals that meet
certain criteria. See 42 C.F.R. § 400.202.

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(1) They are furnished—
***
(iv) Under the direct supervision . . . of a physician or
a nonphysician practitioner as specified in paragraph (g) of
this section, subject to the following requirements:
(A) For services furnished in the hospital or CAH
. . . “direct supervision” means that the physician or
nonphysician practitioner must be immediately available to
furnish assistance and direction throughout the performance
of the procedure. It does not mean that the physician or
nonphysician practitioner must be present in the room when
the procedure is performed;
***
(C) Nonphysician practitioners may provide the
required supervision of services that they may personally
furnish in accordance with State law . . . ;
***
(g) For purposes of this section, “nonphysician practitioner”’
means a clinical psychologist, licensed clinical social worker,
physician assistant, nurse practitioner, clinical nurse
specialist, or certified nurse-midwife.
Baker’s argument focuses on the statement in subparagraph (a)(1)(iv)(C) that
“direct supervision” can come through a nonphysician practitioner if the nonphysician
practitioner “may personally furnish [the relevant service] in accordance with State law.”
Baker argues that Colorado does not permit nonphysician practitioners to “furnish”
radiation therapy services. Baker specifically points to regulations promulgated by the
Colorado state board of health stating that “[n]o individual shall be exposed to the
useful beam [i.e., therapeutic radiation] except for medical therapy purposes pursuant
to a written directive by an authorized user.” 6 Colo. Code Regs. § 1007-1:24.3.8.
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“Authorized user” means “a physician who has a current active State of Colorado
license” who has been certified by certain accrediting organizations in radiology,
therapeutic radiology, radiation oncology, or similar disciplines. Id., App’x 2K. Such a
physician must also complete 700 hours of specified education and training, as well as
three years of supervised clinical practice. Id.
Given these regulations, Baker argues that only a physician with the foregoing
credentials may “personally furnish” radiation therapy “in accordance with State law.”
42 C.F.R. § 410.27(a)(1)(iv)(C). Baker’s interpretation is straightforward and appears
correct on its face. Banner, however, offers several counterarguments, which the Court
will address in turn.
Banner first emphasizes that § 410.27 permits nonphysician practitioners to
provide the required “direct supervision.” (ECF No. 52 at 13–15.) Banner is correct, but
this argument does not address § 410.27(a)(1)(iv)(C)’s requirement that the
nonphysician practitioner be permitted under “State law” to “personally furnish” the
service that he or she is supervising.
As to that, Banner claims that Colorado law actually does allow an advanced
practice nurse to prescribe radiation therapy. (ECF No. 52 at 15–21.) Banner focuses
on the term “practitioner of the healing arts,” which is a term of art in Colorado statutes
and regulations relating to healthcare, and which Banner claims to encompass
advanced practice nurses. (See id. at 17 & n.9.) Banner then highlights the following
language from a Colorado statute authorizing the state board of health to regulate
radiation-emitting machines: “The rules adopted pursuant to this [authorization] shall
never be construed to limit the kind or amount of radiation that may be intentionally
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applied to a person for diagnostic or therapeutic purposes by or under the direction of a
duly licensed practitioner of the healing arts.” Colo. Rev. Stat. § 25-11-104(3). Banner
takes this to mean that, by statute, a practitioner of the healing arts (including an
advanced practice nurse) cannot be prohibited from furnishing radiation therapy.
Even assuming that “practitioner of the healing arts” includes advanced practice
nurses, this argument has a number of flaws. To begin, the statute at issue appears to
be directed at regulations regarding the safe use of radiation-emitting medical
equipment. See generally Colo. Rev. Stat. §§ 25-11-101 through -113. It is not clear
that this statute governs qualifications for prescribing radiation therapy. Perhaps it
does, but Banner has pointed this Court to nothing establishing that the Colorado
regulations on which Baker relies derive from this particular statute’s delegation of
rulemaking authority.
Even if this statute provides the authority Banner claims, Banner’s argument
implicitly reduces to an assertion that the Colorado regulations on which Baker relies
conflict with a Colorado statute. The Eleventh Amendment prohibits this Court from
delving into any such conflict. See Pennhurst State Sch. & Hosp. v. Halderman, 465
U.S. 89, 106 (1984) (“. . . it is difficult to think of a greater intrusion on state sovereignty
than when a federal court instructs state officials on how to conform their conduct to
state law. Such a result conflicts directly with the principles of federalism that underlie
the Eleventh Amendment.”). Thus, the Court sees no relevance in the statutory
directive that the state board’s rules “shall never be construed to limit the kind or
amount of radiation that may be intentionally applied to a person for diagnostic or
therapeutic purposes by or under the direction of a duly licensed practitioner of the
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healing arts.” Colo. Rev. Stat. § 25-11-104(3).
Banner also appears to claim that Colorado law at least allows an advanced
practice nurse to supervise radiation therapy sessions. (ECF No. 52 at 16.) The Court
need not address that question, however, because it is not material to the current
inquiry. Banner seems to be saying that “the required supervision of services that
[nonphysician practitioners] may personally furnish in accordance with State law,” 42
C.F.R. § 410.27(a)(1)(iv)(C), refers to the “service” of supervising a radiation therapy
session. But this effectively rewrites the regulation to address “the required supervision
of supervision that nonphysician practitioners may personally furnish in accordance with
State law,” which is nonsense. Thus, whether advanced practice nurses may supervise
radiation therapy sessions does not inform whether they may “personally furnish”
radiation therapy under § 410.27.
Banner finally falls back on the procedures surrounding radiation therapy. (ECF
No. 52 at 19–20.) Banner points out that a radiation prescription is m eticulously
developed through cooperation between a radiation oncologist, a dosimetrist, a medical
physicist, and a radiation therapist. (Defendants’ Additional Facts ¶¶ 4–13.) Moreover,
[o]nce the operator turns the machine on for a daily therapy
session, it is not possible for anyone to revise the energy of
the beam, the dose per fraction of treatment, or the
treatment site. The only options are to deliver the therapy
completely or to turn off the machine before the therapy
session is complete.
(Id. ¶ 14.) And, if the radiation oncologist decides that the patient needs a dif ferent
dose of radiation, the full process of creating a radiation prescription must be repeated.
(Id. ¶ 15.)
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By raising these facts, Banner appears to be saying that it is unnecessary for
radiation therapy sessions to be supervised by the type of physician that may
personally furnish radiation services under Colorado law—because there is really
nothing that such a physician could do during the session other than direct that the
radiation machine be shut off prematurely. Banner further asserts that “treating a
patient who is dehydrated and light-headed [during a therapy session], controlling pain,
or helping with shortness of breath” are “well within the scope of practice of [an]
advanced practice nurse.” (ECF No. 52 at 21.)
All of this may be true, but the Center for Medicare and Medicaid Services
(“CMS”), which promulgated 42 C.F.R. § 410.27, has already rejected Banner’s basic
premise. In the Federal Register commentary accompanying the finalization of
§ 410.27, CMS noted a comment from a concerned party
request[ing] that CMS consider the direct supervision
requirement to be met for diagnostic or therapeutic radiation
oncology services if a non-specialist practitioner who can
handle an emergency provides the direct supervision and
also has access by phone or other telemedicine link to a
specialist who is able to change the plan of care should the
need arise.
75 Fed. Reg. 71800, 72012 (Nov. 24, 2010). CMS responded:
We do not believe it is sufficient or consistent with our rules
for direct supervision for the individual on site to be capable
of only emergency management. The supervisory
practitioner or nonphysician practitioner who is physically
present should have the training and knowledge to clinically
redirect the service or provide additional orders.
Id. Banner does not argue that CMS did not have authority to interpret its regulation in
such a manner, or that its interpretation is unreasonable, or that the interpretation
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deserves no deference. Accordingly, although Banner’s explanation of the practical
realities of radiation therapy raises an interesting question about why CMS requires
supervision by a highly trained specialist, the fact remains that CMS specifically
considered and rejected a lesser requirement.
In sum, the Court concludes that Baker’s interpretation of 42 C.F.R. § 410.27 is
correct. Specifically, the portion of the regulation stating that “[n]onphysician
practitioners may provide the required supervision of services that they may personally
furnish in accordance with State law” does not currently apply in Colorado because
Colorado law does not allow nonphysician practitioners to “personally furnish” radiation
therapy services. The Court emphasizes, however, that this ruling does not resolve any
question of intent under the False Claims Act. See, e.g., 31 U.S.C. § 3729(a) (requiring
“knowing[]” presentation of false claims).
IV. CONCLUSION
For the reasons set forth above, Baker’s Early Motion for Partial Summary
Judgment (ECF No. 51) is GRANTED.
Dated this 28th day of May, 2015.
BY THE COURT:

William J. Martínez
United States District Judge

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