Donald Dobson v. Secretary of Health and Human Services ( 2022 )

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[DO NOT PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 20-11996
Non-Argument Calendar
____________________
DONALD DOBSON,
Plaintiff-Appellant,
versus
SECRETARY OF HEALTH AND HUMAN SERVICES,
Defendant-Appellee.
____________________
Appeal from the United States District Court
for the Southern District of Florida
D.C. Docket No. 4:18-cv-10038-JB
____________________
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2 Opinion of the Court 20-11996
Before WILSON, ROSENBAUM, and HULL, Circuit Judges.
PER CURIAM:
Appellant Donald Dobson is a Medicare participant. As a
result of disease, he suffers from intractable and severe nausea and
vomiting, which interfere with his ability to function and threaten
other aspects of his medical condition. Dobson’s doctors tried in
vain to relieve Dobson’s condition by prescribing various medica-
tions. None worked. None, that is, until they tried dronabinol.
But dronabinol is not FDA-approved for use in this way, so
Medicare Part D would not reimburse Dobson for the drug unless
his use qualified as an approved off-label use, known as a “medi-
cally accepted indication.” This case requires us to determine
whether the statutory definition of “medically accepted indication”
covers Dobson’s off-label use of dronabinol to relieve disease-re-
lated stubborn nausea and vomiting.
We conclude that the governing statute’s text and structure,
as well its purpose, require the conclusion that the term “medically
accepted indication” includes those off-label uses for which an ap-
proved medical compendium tends to show or helps prove the ef-
ficacy and safety of the prescribed off-label use. Because the use of
dronabinol to relieve refractory, disease-related nausea and vomit-
ing satisfies that standard, we vacate the district court’s entry of
summary judgment for Appellee Secretary of Health and Human
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20-11996 Opinion of the Court 3
Services and its denial of summary judgment for Dobson and re-
mand with instructions to enter summary judgment for Dobson.
I.
A. Statutory and Regulatory Framework
To explain some of the factual and procedural background,
we must begin with a description of the statutory and regulatory
framework that governs this case.
In its current iteration, Medicare is a federal health-insur-
ance program for those who are at least 65 years old and for the
disabled, among others. 42 U.S.C. § 1395 et seq. Medicare traces
its roots to 1965, when Congress, as part of the Social Security Act,
originally created the program.
In 2003, Congress added Medicare Part D—a subsidized pre-
scription drug benefit program. Jennifer O’Sullivan, Medicare Part
D Prescription Drug Benefit: A Primer, Cong. Rsch. Serv. 1 (Aug.
20, 2008). https://www.everycrsreport.com/files/20080820_RL3
4280_e39d4ec97b3863a3a1184d12f5aa790527fd3174.pdf. To ad-
minister Medicare Part D, the Centers for Medicare & Medicaid
Services (“CMS”), a part of the U.S. Department of Health and Hu-
man Services, contracts with private insurers, called “plan spon-
sors,” to provide prescription drug coverage to Medicare benefi-
ciaries for “covered part D drugs.” 42 U.S.C. §§ 1395w-111 to
1395w-112.
Beneficiaries who enroll in Part D select their preferred
sponsor and pay out-of-pocket expenses, such as monthly
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4 Opinion of the Court 20-11996
premiums and deductibles. Id. § 1395w-102(b); see also Akebia
Therapeutics, Inc. v. Azar, 976 F.3d 86, 89 (1st Cir. 2020) (providing
background on Part D). The sponsors then receive reimburse-
ments from the Medicare program for the cost of the covered
drugs. Id. at 89.
A Medicare Part D plan will cover the cost of only those pre-
scription drugs that are considered “covered part D drugs.” Id. §
1395w-102(e)(1). The statute defines “covered part D drug[s]” as
those that are used “for a medically accepted indication.” Id. In
turn, the statute defines “medically accepted indication” as “any
use for a covered outpatient drug which is approved under the Fed-
eral Food, Drug, and Cosmetic Act or the use of which is supported
by one or more citations included or approved for inclusion in any
of the compendia described in subsection (g)(1)(B)(i).” 42 U.S.C. §
1396r-8(k)(6); see also id. § 1395w-102(e)(4)(A)(ii) (incorporating
definition from § 1396r-8(k)(6)).
Uses approved by the FDA are called “on-label” uses, while
those that are not are called “off-label” uses. So Medicare Part D
covers (1) “on-label” uses and (2) “off-label” uses that are “sup-
ported by one or more citations included or approved for inclusion
in” approved drug compendia. 42 U.S.C. § 1396r-8(k)(6).
The governing statute lists three approved compendia that
may provide a supporting citation for an off-label use. The com-
pendia are “large reference books that contain a variety of infor-
mation about the prescription pharmaceuticals currently available
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20-11996 Opinion of the Court 5
on the American market—everything from their chemical makeup
to potential side-effects to the age ranges of patients the drugs have
been tested on.” United States v. King-Vassel, 728 F.3d 707, 715
(7th Cir. 2013). As relevant here, one of the three approved com-
pendia is known as the DRUGDEX Information System
(“DRUGDEX”). 42 U.S.C. § 1396r-8(g)(1)(B)(i).
B. Factual Background
In August 2009, Dobson sustained serious injuries to his
neck and spinal cord. To address these problems, he underwent
surgery in September 2009. At that time, doctors implanted an ar-
tificial disk in his spinal cord. A couple months later, in December
2009, Dobson underwent a second surgery to fix some of the “hard-
ware” that doctors had implanted in September.
Based on his injury and related surgeries, Dobson was diag-
nosed with Central Cord Syndrome and Eagle Syndrome. Central
Cord Syndrome “is the most common form of incomplete spinal
cord injury characterized by impairment in the arms and hands and
to a lesser extent in the legs.” Central Cord Syndrome Information
Page, National Institute of Health (March 27, 2019),
https://www.ninds.nih.gov/Disorders/All-Disorders/Central-
Cord-Syndrome-Information-Page (last visited Feb. 11, 2022). The
syndrome is “associated with damage to the large nerve fibers that
carry information directly from the cerebral cortex to the spinal
cord.” Id. As for Eagle Syndrome, that “is characterized by recur-
rent pain in the middle part of the throat . . . and face.” Eagle
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6 Opinion of the Court 20-11996
Syndrome, National Institute of Health (Apr. 18, 2017), https://ra-
rediseases.info.nih.gov/diseases/9401/eagle-syndrome (last vis-
ited Feb. 11, 2022).
Following his surgeries, Dobson developed symptoms of
vomiting, frequent headaches, severe neck pain, torso pain, and
weight loss. He also often experienced convulsive movements or
spasms when he tried to fall asleep, and he had difficulty sleeping.
Though he has received treatment for these conditions, Dobson
continues to suffer from episodes of severe nausea and vomiting
multiple times each day. Based on these circumstances, Dobson
has also been diagnosed with autonomic dysreflexia (also known as
“dysautonomia”), a syndrome common in people with spinal-cord
injuries. Dysreflexia is characterized by the sudden onset of dan-
gerously high blood pressure, excessive sweating, nausea, and cy-
clic vomiting.
Dobson worries that the constant vomiting will dislodge the
disc in his neck. His constant nausea and vomiting also put him at
risk for serious medical complications, including stroke, high blood
pressure, seizures, increased muscle pain, and muscle spasms.
At first, Dobson’s doctors had trouble treating Dobson’s per-
sistent nausea and vomiting because the usual drugs used to treat
those symptoms would not work. Dobson even had a severe aller-
gic reaction to one of the medications—Reglan (metoclopramide).
Eventually, his doctors prescribed Marinol (a brand name of
dronabinol).
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20-11996 Opinion of the Court 7
The medication worked almost immediately, and Dobson’s
symptoms subsided. Dobson’s doctor, Dr. Shaun C. Corbett, de-
scribed dronabinol as a “palliative treatment for [Dobson’s] disease-
related symptoms of nausea and vomiting” and characterized the
results of using the medication as “excellent.” Indeed, Dr. Corbett
explained that dronabinol was the optimal treatment for Dobson.
He also opined that the DRUGDEX compendium supported Dob-
son’s use of dronabinol.
For dronabinol, DRUGDEX lists two FDA-approved (on-la-
bel) uses and six non-FDA-approved (off-label) uses. For each cited
use of dronabinol, DRUGDEX provides an overview on the partic-
ular use, its efficacy, grade of recommendation, and strength-of-ev-
idence ratings. DRUGDEX also includes a summary that explains
the evidentiary basis for each use recommended. According to the
DRUGDEX listing for dronabinol, the FDA has approved
dronabinol for on-label uses for “AIDS-loss of appetite” and
“[c]hemotherapy-induced nausea and vomiting, in patients with in-
adequate response to conventional antiemetic treatments.”
The DRUGDEX compendium also lists six non-FDA ap-
proved (off-label) uses. As relevant here, one of those listed uses is
for “[n]ausea and vomiting, [d]isease-related, treatment refrac-
tory.”
That citation has three main components: the title (noted
above), the “Overview” section, and the “Summary” section.
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8 Opinion of the Court 20-11996
The “Overview” section provides (1) information on effi-
cacy, (2) a grade of recommendation, and (3) a rating on the
strength of evidence. For this citation, the “Overview” says that
the “[e]vidence favors efficacy,” and it lists the strength of evidence
as Category C, which means that the evidence for the citation is
“derived from: Expert opinion or consensus, case reports or case
series.” This citation also has a class IIb use recommendation. A
class IIb recommendation means that the “given . . . treatment may
be useful, and is indicated in some, but not most, cases.” Put
simply, a class IIb rating, means the medication is “recommended,
in some cases.” (capitalization altered).
Moving to the “Summary” section, that contains infor-
mation about the scientific study or evidence that provides the ba-
sis for the citation. It states that “[i]ntractable nausea and vomiting
related to metastatic cancer of the gastrointestinal mucosa resolved
only after addition of [dronabinol].” The remainder of the citation
then summarizes a single case study of a 50-year-old patient with a
metastatic malignant tumor in the mucosa of his stomach. The
patient was admitted to the hospital with a variety of symptoms
including “severe nausea and vomiting.” The authors of the study
believed the nausea and vomiting were “principally” attributed to
his gastrointestinal cancer. Though the doctors prescribed various
medications to alleviate the study patient’s nausea and vomiting,
nothing worked. Eventually, after several days in the hospital, doc-
tors administered dronabinol, which successfully alleviated the
study patient’s nausea and vomiting.
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20-11996 Opinion of the Court 9
The study cited in the compendium was published in the
Journal of Pain and Symptom Management. See Francisco Gonza-
lez-Rosales & Declan Walsh, Intractable Nausea and Vomiting
Due to Gastrointestinal Mucosal Metastases Relieved by Tetrahy-
drocannabinol (Dronabinol), 14 J. of Pain & Symptom Manag. 311
(1997), https://www.jpsmjournal.com/article/S0885-3924(97)00
229-7/pdf. The study explained that after the study patient was ad-
ministered dronabinol, his nausea and vomiting completely
abated. Though the authors did not know with certainty how
dronabinol worked to alleviate the patient’s nausea and vomiting,
they posited that it might work by “indirect inhibition of the vom-
iting center in the medulla as a result of binding to opiate receptors
in the forebrain.” Id. at 313.
C. Procedural Background
With this information in mind, we discuss how this case got
to us. The procedural background here involves Medicare admin-
istrative proceedings as well as proceedings in the district court.
1. The Administrative Proceedings
After his injury, Dobson became a Medicare beneficiary and
enrolled in a Part D prescription drug plan with UnitedHealthCare.
In December 2015, Dobson’s physician submitted a request to his
Part D prescription drug plan for prior authorization of coverage
for his dronabinol prescription. After UnitedHealthCare denied
coverage, Dobson’s doctor filed an appeal with the
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10 Opinion of the Court 20-11996
UnitedHealthCare Medicare Part D Appeals and Grievance De-
partment in December 2016. The Grievance Department denied
the claim because it concluded that “[d]ronabinol is not FDA ap-
proved for nausea and vomiting not associated with cancer, chem-
otherapy, or following breast surgery. This condition is not one of
the uses for the drug listed in . . . DRUGDEX. Therefore, this drug
is not a Medicare Part D drug.”
Dobson filed another appeal in February of 2017. Again, the
Grievance Department denied the appeal. It concluded that
“[d]ronabinol is not FDA approved for nausea and vomiting related
to Eagle Syndrome and central cord syndrome. This condition is
not one of the uses for the drug listed in . . . DrugDex. Therefore,
this drug is not a Medicare Part D drug.”
Dobson then appealed that decision through three levels of
Medicare administrative review. Primarily, Dobson argued that
the DRUGDEX entry titled, “Nausea vomiting, Disease-related,
treatment refractory,” supported his use of dronabinol. On April
4, 2017, Dobson filed a Reconsideration Request with Medicare
Part D’s Independent Review Entity (“IRE”), MAXIMUS Federal
Services. The IRE ruled against Dobson, concluding that the Part
D Plan is not required to cover dronabinol to “treat an enrollee
with nausea and vomiting related to Eagle syndrome and central
cord syndrome.” It also opined that the approved compendia “do
not contain any citations to support the use of [dronabinol] for
these conditions.” As a result, the IRE concluded, the drug “is not
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20-11996 Opinion of the Court 11
being prescribed for a medically accepted indication as defined by
Medicare law.”
Next, on June 30, 2017, Dobson appealed the IRE’s decision
to an administrative law judge (“ALJ”) and requested a hearing.
The ALJ held a telephonic hearing on August 14, 2017. Dobson
testified at the hearing and was represented by counsel. The ALJ
later issued a decision affirming the IRE’s denial of coverage for
Dobson’s use of Dronabinol. In reaching this decision, the ALJ con-
cluded that “[d]ronabinol is not approved by the FDA for the En-
rollee’s medical condition or indicated by the appropriate compen-
dia as accepted for treatment of the Enrollee’s medical condition.”
Finally, Dobson timely appealed the ALJ’s decision to the
Medicare Appeals Council. The Council upheld the ALJ’s denial of
Part D coverage for Dobson’s off-label use of dronabinol. Accord-
ing to the Council, the citation in the DRUGDEX compendium
supported “the use of dronabinol to treat nausea and vomiting re-
lated to [only] metastatic cancer of the gastronintestinal mucosa
that is treatment refractory.” For that reason, the Council con-
cluded, the citation could not be used to support the use of
dronabinol to treat Central Cord Syndrome and Eagle Syndrome.
The Council also opined that the medically accepted indications
standard could not “turn on an enrollee’s symptoms, alone.” Ra-
ther, in the Council’s opinion, the determination must be based on
the diagnosis or condition for which the drug is being prescribed.
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12 Opinion of the Court 20-11996
Nevertheless, the Council did agree with the parties that
dronabinol was medically necessary in Dobson’s case.
2. District Court Proceedings
After the Council’s decision, Dobson filed suit in the district
court. The parties filed cross-motions for summary judgment. Af-
ter consideration, the district court entered an order denying Dob-
son’s motion and granting the Secretary’s. 1
In its order, the district court first addressed whether the
Council’s decision should be afforded deference under either Chev-
ron USA v. Natural Resources Defense Council, Inc., 467 U.S. 837(1984) or Skidmore v. Swift & Co., 323 U.S. 134 (1944). The district
court determined that Chevron does not apply because Congress
did not “delegate authority to the Secretary [of the Department of
Health and Human Resources] ‘to make rules carrying the force of
law’ with respect to Part D coverage of an off-label drug, nor did it
explicitly leave a gap for the Secretary to fill with rules that carry
the force of law.” But the district court did apply Skidmore defer-
ence to the Council’s decision. In so doing, the district court rea-
soned that Medicare law is “complex,” which puts the Council “in
a better position to evaluate questions involving subject matter[s]
that are technical, complex, and dynamic.”
1 The parties consented to adjudication by a magistrate judge.
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As for the merits, the district court was persuaded by the
Council’s reading of the relevant citation in the DRUGDEX com-
pendium. The court noted that, upon “[r]eading the entire cita-
tion,” the Council found that the citation applied “to [only] cases
where patients are suffering from metastatic cancer of the gastro-
intestinal mucosa.” In other words, the district court, opined, the
citation did not apply to “any case where a patient has nausea and
vomiting related to any disease.” In the district court’s view, only
that reading avoided rendering “the remainder of the citation su-
perfluous.” The district court also found that the Council’s inter-
pretation was supported by the Medicare Prescription Drug Benefit
Manual and previous Council decisions.
Dobson filed a timely notice of appeal.
II.
We review de novo the district court’s grant of summary
judgment to the Secretary, “viewing the facts and drawing all rea-
sonable inferences in favor of the nonmoving party.” Moore ex re.
Moore v. Reese, 637 F.3d 1220, 1231 (11th Cir. 2011). “Summary
judgment is appropriate when ‘there is no genuine dispute as to
any material fact’ and the moving party is entitled to judgment as
a matter of law.” Id. (quoting Fed. R. Civ. P. 56(a)).
We review the Secretary’s decision regarding a claim for
Medicare benefits under the standards set forth in 42 U.S.C. §
405(g), which has been incorporated into the Medicare statute at
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14 Opinion of the Court 20-11996
42 U.S.C. § 1395w-22(g)(5) and 42 U.S.C. § 1395ff(b)(1)(A). See
Gulfcoast Med. Supply, Inc. v. Sec’y, Dep’t of Health & Human
Servs., 468 F.3d 1347, 1350 n.3 (11th Cir. 2006) (“Gulfcoast”). Un-
der § 405(g), we review the Secretary’s findings of fact for substan-
tial evidence. 42 U.S.C. § 405(g) (“The findings of [the Secretary]
as to any fact, if supported by substantial evidence, shall be conclu-
sive”); Gulfcoast, 468 F.3d at 1350 n.3. “Substantial evidence is
more than a scintilla and is such relevant evidence as a reasonable
person would accept as adequate to support a conclusion.” Fla.
Med. Ctr. of Clearwater, Inc. v. Sebelius, 614 F.3d 1276, 1280 (11th
Cir. 2010). With respect to the Secretary’s legal conclusions, we
engage in de novo review. See Martin v. Soc. Sec. Admin.,
Comm’r, 903 F.3d 1154, 1159 (11th Cir. 2018).
III.
A. The initial question here—the meaning of “supported
by” in 42 U.S.C. § 1396r-8(k)(6)—presents a question of
law
Here, the Secretary argues that Dobson challenges a factual
finding, so we should review for substantial evidence. On this rec-
ord, we disagree. The parties agree on the key facts related to Dob-
son’s medical history. For example, they agree that he had two
surgeries to his back and neck, that he was diagnosed with Central
Cord Syndrome and Eagle Syndrome, that he suffers from persis-
tent nausea and vomiting as a result of his back and neck injuries,
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20-11996 Opinion of the Court 15
and that dronabinol has helped alleviate Dobson’s nausea and vom-
iting.
The only question at issue is whether Dobson’s use of the
drug dronabinol to alleviate his constant nausea and vomiting
meets the standard Congress set for coverage under Medicare Part
D—that is, whether it is “supported by [at least one] citation[] in-
cluded . . . in [DRUGDEX].” 42 U.S.C. § 1396r-8(k)(6).
In the first instance, that requires us to construe the term
“supported by” in the governing statute. And statutory construc-
tion presents a question of law. United States v. Endotec, Inc., 563
F.3d 1187, 1194 (11th Cir. 2009). Indeed, “[t]he judiciary is the final
authority on issues of statutory construction and must reject ad-
ministrative constructions which are contrary to clear congres-
sional intent.” Chevron, 467 U.S. at 843 n.9.
B. The text, structure, purpose, and legislative history of 42
U.S.C. § 1396r-8(k)(6) require the conclusion that “sup-
ported by” means that the compendium citation relied
upon must tend to show or help prove the efficacy and
safety of the prescribed off-label use
When we review an agency’s construction of a statute it ad-
ministers, the first step always requires us to ascertain whether the
meaning of the provision is “genuinely ambiguous” on the ques-
tion at issue. See Kisor v. Wilkie, 139 S. Ct. 2400, 2414 (2019); see
also Chevron, 467 U.S. at 842-43. For “the possibility of deference
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16 Opinion of the Court 20-11996
can arise only if a [provision] is genuinely ambiguous.” Kisor, 139
S. Ct. at 2414; see also Chevron, 467 U.S. at 842-43. And as the
Supreme Court has recently emphasized, when [the Supreme
Court] use[s] that term, [it] mean[s] it—genuinely ambiguous, even
after a court has resorted to all the standard tools of interpretation.”
Kisor, 139 S. Ct. at 2414. Indeed, “a court cannot wave the ambi-
guity flag just because it found the [provision] impenetrable on first
read.” Id. at 2415.
“If the intent of Congress is clear, that is the end of the mat-
ter; for the court, as well as the agency, must give effect to the un-
ambiguously expressed intent of Congress.” Chevron, 467 U.S. at
842-43. In that case, “there is no plausible reason for deference.”
Kisor, 139 S. Ct. at 2415. As the Court has explained in the context
of considering whether deference is due an agency’s interpretation
of its own regulation, “if there is only one reasonable construction
of a [provision]—then a court has no business deferring to any
other reading, no matter how much the agency insists it would
make more sense.” Id. “Deference in that circumstance would
permit the agency, under the guise of interpreting a [provision], to
create de facto a new [provision].” Id. (cleaned up).
Therefore, we begin our inquiry with a hard and deep look
at the governing statutory provision. As we explain below, our re-
view yields fruit: the intent of Congress here is clear and 42 U.S.C.
§ 1396r-8(k)(6) is not genuinely ambiguous. For that reason, we do
not defer to the Medicare Appeals Council’s interpretation of the
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20-11996 Opinion of the Court 17
term “supported by,” and instead must give effect to the unambig-
uously expressed intent of Congress.
Here, we must determine the meaning of “supported by [at
least one] citation[] included . . . in [DRUGDEX]” in 42 U.S.C. §
1396r-8(k)(6). We ascertain whether Congress had an intention on
that question by “employing traditional tools of statutory construc-
tion.” Id. at 843 n.9. Those tools include reviewing the text of the
statute and the statute’s structure (which we examine using the
rules of statutory construction as appropriate), the statute’s stated
purpose, and the statute’s legislative history. See In re Gateway
Radiology Consultants, P.A., 983 F.3d 1239, 1256, 1261 n.9 (11th
Cir. 2020).
The Supreme Court has explained that “our inquiry begins
with the statutory text,” and if that is “unambiguous,” it “ends
there as well.” Nat’l Ass’n of Mfrs. v. Dep’t of Def., 138 S. Ct. 617,
631 (2018) (citation and quotation marks omitted). Here, the stat-
utory scheme does not define the material term “supported by.”
So we must consider the “common usage of words for their mean-
ing.” In re Walter Energy, Inc., 911 F.3d 1121, 1143 (11th Cir. 2018)
(citation and quotation marks omitted). To do that, “we often look
to dictionary definitions for guidance.” Id. Nevertheless, we must
then consider the term as used in its statutory context. Id. Along
the way, the canons of construction can provide helpful assistance
in understanding the broader statutory context. Id.USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 18 of 28
18 Opinion of the Court 20-11996
The Oxford English Dictionary defines the verb “support”
to mean “[t]o provide evidence or authority for, or corroboration
of, (a statement, etc.); to bear out, substantiate.” Support, v., Ox-
ford English Dictionary, https://www.oed.com/view/Entry/
194674?rskey=MoK3yx&result=2#eid (last visited Feb. 11, 2022)
(definition 6.b). Similarly, Webster’s New World College Diction-
ary defines “support” as “to show or tend to show to be true; help
prove; vindicate, or corroborate.” See Support, Webster’s New
World College Dictionary (3d ed. 1997).
Using these definitions to construe the phrase “supported
by” as used in § 1396r-8(k)(6) therefore requires the conclusion that
the compendium citation must tend to show or help prove the ef-
ficacy and safety of the prescribed off-label use. Nothing about the
common meaning of “support” means that a compendium citation
must hyperspecifically identify a prescribed off-label use to tend to
show or help prove its efficacy and safety.
And while the compendia themselves are obviously not a
part of the statute, any reading of the statute must make sense in
terms of how it applies to the compendia. So it is appropriate to
examine the compendia entries for additional clues they may pro-
vide in helping us to understand what Congress meant when it re-
quired a compendium entry to “support” the prescribed off-label
use.
We use the DRUGDEX entry at issue here as an example.
As relevant here, under “Dronabinol,” the DRUGDEX entry
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20-11996 Opinion of the Court 19
identifies six “[n]on-FDA [u]ses”: (1) “Gilles de la Tourette’s syn-
drome”; (2) “Loss of appetite, Cancer-related”; (3) “Multiple scle-
rosis – Spasticity”; (4) “Nausea and vomiting, Disease-related, treat-
ment refractory”; (5) “Postoperative nausea and vomiting; Treat-
ment and Prophylaxis”; and (6) “Pruritus, Cholestasis-associated,
treatment refractory.” Notably, these titles range from the very
specific—“Pruritus, Cholestasis-associated, treatment refrac-
tory”—to the more general—“Nausea and vomiting, Disease-re-
lated, treatment refractory.” The pruritus 2 entry, for example,
specifies an off-label use of dronabinol for itchy skin, but only as
the itchiness is associated with cholestasis 3—a very specific condi-
tion—and then, only when the itching is stubborn and otherwise
unmanageable. Meanwhile, the nausea-and-vomiting entry, at
least by its title, encompasses nausea and vomiting that are related
to any kind of disease, as long as the nausea and vomiting are stub-
born and otherwise unmanageable.
In other words, some citation titles appear to convey very
specific disease-focused off-label uses, while others suggest broader
off-label uses geared towards particular symptoms but arising from
disease more generally. That the titles to the drug-compendium
2 Pruritus is itching of the skin. https://www.mayoclinic.org/diseases-condi-
tions/itchy-skin/symptoms-causes/syc-20355006 (last visited Feb. 11, 2022).
3 Cholestasis is the “reduction or stoppage of bile flow.”
https://www.merck-
manuals.com/home/liver-and-gallbladder-disorders/manifestations-of-liver-
disease/cholestasis (last visited Feb. 22, 2022).
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 20 of 28
20 Opinion of the Court 20-11996
citations identify both very specific and more general off-label uses
suggests the difference between the two types of entries has mean-
ing—namely, that some citations support only limited, precise ap-
plications, while others support broader applications.
Of course, we don’t hold drug-compendium entries to the
canons we apply to statutory construction. But we do presume
Congress was aware of the differences among entries when it de-
fined “[m]edically accepted indication” to be one “which is sup-
ported by one or more citations included or approved for inclusion
in” approved medical compendia and it authorized the Secretary to
add compendia such as DRUGDEX to the list. See 42 U.S.C. §
1396r-8(g)(B)(i)(III).
Thus, considering only the title of the citation on which
Dobson relies—“Nausea and vomiting, Disease-related, treatment
refractory”—we would have to conclude that the citation supports
Dobson’s use: nausea and vomiting—check; disease-related—
check (Central Cord Syndrome and Eagle Syndrome); treatment
refractory—check (the usual drugs used to treat nausea and vomit-
ing did not work, and Dobson had a severe allergic reaction to one
of them (metoclopramide)).
But of course, the title of a citation alone does not support
an off-label application if the citation’s overview and summary are
inconsistent with that application. So we must also consider those.
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 21 of 28
20-11996 Opinion of the Court 21
Beginning with the overview section, nothing from this part
of the citation contraindicates use of dronabinol under Dobson’s
circumstances. As we have mentioned, the overview indicates that
(1) the “[e]vidence favors efficacy” for adults; (2) the strength of ev-
idence falls within “Category C,” meaning the evidence for the ci-
tation is “derived from: Expert opinion or consensus, case reports
or case series”; and (3) the recommendation is class IIb, meaning
that “given . . . treatment may be useful, and is indicated in some,
but not most, cases.” Using dronabinol for refractory, disease-re-
lated nausea and vomiting falls within the parameters the overview
identifies. Nausea and vomiting are common conditions associated
with a variety of circumstances, many of which are not disease-re-
lated, such as seasickness, pregnancy, vertigo, surgery, and more.
And Dobson’s doctors’ attempts to use the “usual” antinausea and
vomiting drugs on Dobson before turning to dronabinol suggests
that even disease-related nausea and vomiting are not generally un-
treatable with other drugs’ labeled uses. So Dobson’s understand-
ing of the citation to support refractory, disease-related nausea and
vomiting is consistent with the notion indicated in the overview
that “treatment [with dronabinol] may be useful, and is indicated
in some, but not most, cases” of nausea and vomiting.
As for the summary section, that states, “Intractable nausea
and vomiting related to metastatic cancer of the gastrointestinal
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 22 of 28
22 Opinion of the Court 20-11996
mucosa resolved only after addition of tetrahydrocannabinol.”4 It
then goes on to explain, in relevant part,
Adding tetrahydrocannabinol (THC) to therapy pro-
duced resolution of refractory nausea and vomiting in
a 50-year-old man with metastatic malignant mela-
noma. . . . On day 8 after admission, oral THC
(Dronabinol(R)) 5 mg after meals and at bedtime was
initiated. Four days later he was tolerating a soft diet.
By the next day, he was reporting no pain, nausea, or
vomiting. He was discharged 6 days after the start of
THC, with no recurrence of nausea or vomiting. The
authors attributed the patient’s [nausea and vomiting]
principally to the diffuse gastrointestinal mucosal me-
tastases.
(emphasis added). We think there are two ways to view this sum-
mary: (1) as simply a description of the evidence on which the
more general off-label use identified in the citation title is based (in
which case the off-label use is limited by the citation title’s
4 Dronabinol is an isomer of tetrahydrocannabinol. https://pub-
chem.ncbi.nlm.nih.gov/compound/Dronabinol (last visited Feb. 11, 2022).
Isomers are “[m]olecules that share the same chemical formula but have their
atoms connected differently, or arranged differently in space.” United States
v. Phifer, 909 F.3d 372, 376 (11th Cir. 2018) (quoting Hydrocarbon structures
and isomers, Khan Academy, https://www.khanacademy.org/science/biol-
ogy/properties-of-carbon/hydrocarbonstructures-and-functional-
groups/a/hydrocarbon-structures-and-isomers).
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 23 of 28
20-11996 Opinion of the Court 23
specifications), or (2) as a limitation on the citation title, to only the
precise off-label use described in the study that appears in the sum-
mary. It cannot be viewed as something in between because the
citation provides no limiting principle for such a construction. For
three reasons, we think the first view is the better one in this case.
First, as the summary notes, the study’s authors were careful
to qualify their attribution of the patient’s nausea and vomiting
“principally” to his gastrointestinal mucosal metastases. That—
and that the study on which the citation is based notes that the pa-
tient suffered from numerous ailments—suggests that the authors
did not attribute the patient’s nausea and vomiting entirely to his
gastrointestinal mucosal metastases. See Gonzalez-Rosales &
Walsh, supra, J. of Pain & Symptom Mgmt., at 311 (“[W]e believe
that the main cause [of the patient’s nausea and vomiting] was dif-
fuse metastatic disease in the gastrointestinal tract mucosa.”). In
other words, they attributed the nausea and vomiting at least in
part to other diseases. That suggests the citation is not intended to
be limited to addressing only that nausea and vomiting in patients
suffering from diffuse gastrointestinal mucosal metastases.
Second, viewing the study on which the citation is based as
limiting so narrowly what the citation supports to only those cases
where nausea and vomiting were attributable to gastrointestinal
mucosal metastases would render the title of the citation irrelevant
and superfluous. But the same cannot be said of the summary if
we read the title to mean what it says. In that case, the summary
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 24 of 28
24 Opinion of the Court 20-11996
has meaning as providing the evidence that warrants the citation’s
title.
Third, the study’s authors theorized that dronabinol re-
solves nausea and vomiting through a “central action . . . , perhaps
by indirect inhibition of the vomiting center in the medulla as a
result of binding to opiate receptors in the forebrain.” Nothing
about that process is described in a way peculiar to cases of diffuse
gastrointestinal mucosa metastases (as opposed to being applicable
to nausea and vomiting caused by disease in general).
Overall, we think the common understanding of “support,”
especially in conjunction with a review of the types of entries con-
tained in DRUGDEX and the particular citation involved here, re-
quires the conclusion that the DRUGDEX citation must tend to
show or help prove the efficacy and safety of the prescribed off-
label use. It does not, as the Medicare Appeals Council concluded,
demand that every aspect of the DRUGDEX citation must match
the prescribed off-label use precisely. Had that been Congress’s de-
sire, Congress easily could have used those terms in its definition
of “medically accepted indication.” But it didn’t.
Of course, we need look no further than the clear terms of
the statute. See CBS Inc. v. PrimeTime 24 Joint Venture, 245 F.3d
1217, 1222 (11th Cir. 2001). We note, however, that the legislative
history of Congress’s expansion of Medicare Part D to include off-
label uses also supports this plain-text reading of § 1396r-8(k)(6).
See Id. at 1229 n.7 (recognizing the “bedrock principle” that there
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 25 of 28
20-11996 Opinion of the Court 25
is no need to resort to legislative history where statutory text is
clear, but nonetheless reviewing legislative history that “supports
and complements the plain meaning of statutory language”).
Congress’s decision to amend Medicare Part D to reimburse
for previously uncovered off-label uses of outpatient drugs that are
supported by a citation in the compendia obviously represented an
enlargement of Medicare drug coverage. Though added in 2008,
see Pub. L. 110-275, 122 Stat. 2583, § 182(a) (July 15, 2008), this pro-
vision echoes a similar provision added to the Medicare statute by
the Omnibus Budget Reconciliation Act of 1993, Pub. L. 103-66,
107 Stat. 312–695 Stat. 1025, § 13553(b)(3) (Aug. 10, 1993), codified
at 42 U.S.C. § 1395x(t)(2)(B). As relevant here, the 1993 provision
expanded coverage for the “medically accepted indication[s]” for
which anticancer drugs could be used. Id. It defined “medically
accepted indication,” in part, as “such use [that] is supported by one
or more citations which are included (or approved for inclusion) in
one or more of the following compendia . . . .” Id. The 1993
amendment was enacted following the General Accounting Of-
fice’s (“GAO”) 1991 Report to the Chairman, Committee on Labor
and Human Resources, U.S. Senate (written in response to a re-
quest by that Senator), entitled, “Off-Label Drugs: Reimbursement
Policies Constrain Physicians in Their Choice of Cancer Therapies”
(“GAO Report”).
That report found, among other things, that Medicare “re-
imbursement policies can influence how cancer patients are
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26 Opinion of the Court 20-11996
treated.” GAO Report at 5. Indeed, roughly 23 percent of respond-
ing oncologists stated that they altered their preferred treatments
because certain off-label uses were not covered by Medicare and
they had cost concerns. Id. at 35. So GAO recommended the adop-
tion of “a policy for Medicare reimbursement for off-label drug
use.” Id. at 5. It noted that although off-label use can be beneficial
even when it is not supported by a compendium citation, id. at 40,
use of the drug compendia can be helpful in determining what drug
applications are safe, effective, and not investigational, id. at 41. 5
There appears to be no legislative history expressing any rea-
son for the addition of the 2008 amendment to the definition of
“medically accepted indication” in § 1396r-8 of Part D. But as we
5 During a 1996 hearing before the Subcommittee on Human Resources and
Intergovernmental Relations of the Committee on Government Reform and
Oversight of the House of Representatives, Sarah Jaggar, Director of Health
Services Quality and Public Health Issues for the General Accounting Office,
confirmed that the concerns documented in the 1991 GAO report motivated
the 1993 amendments, as she testified to Congress about the need for laws
regulating promotion and advertisement of off-label drug uses. See Off-Label
Drug Use and FDA Review of Supplemental Drug Applications Report of
Hearing before the Subcommittee on Human Resources and Intergovern-
mental Relations of the Committee on Government Reform and Oversight of
the House of Representatives, 104th Cong., 2d Sess. (Sept. 12, 1996), at 4. Dur-
ing her testimony, she noted that “reimbursement concerns were the primary
ones associated with the drug label in the earlier part of this decade [but that]
this issue seems to have declined significantly since that time [because of ] leg-
islation in 1993 that required Medicare carriers to rely on sources in addition
to the FDA-approved label in making reimbursement decisions for cancer
therapy.” Id. at 13.
USCA11 Case: 20-11996 Date Filed: 02/11/2022 Page: 27 of 28
20-11996 Opinion of the Court 27
have mentioned, the language of that amendment is very similar
to that of the 1993 amendment to the meaning of “medically ac-
cepted indication” under Part B of Medicare. We think that sug-
gests the same or very similar concerns motivated the 2008 amend-
ment to Part D—namely, that Medicare participants receive cover-
age for off-label uses but that those off-label uses be objectively
demonstrated to be efficacious and safe, as demonstrated by their
inclusion in one of the drug compendia. Plus, the statutory defini-
tion of “medically accepted indication” logically indicates as much.
For these reasons, we conclude that the language and struc-
ture of § 1396r-8(k)(6) and the Medicare statute as a whole require
the conclusion that “supported by one or more citations included
or approved for inclusion” in DRUGDEX means that the
DRUGDEX citation relied upon must tend to show or help prove
the efficacy and safety of the prescribed off-label use.
We think the DRUGDEX citation for dronabinol titled
“Nausea and vomiting, Disease-related, treatment refractory” sat-
isfies that requirement as it pertains to Dobson’s use of the drug to
treat his Central-Cord-Syndrome and Eagle-Syndrome-related re-
fractory nausea and vomiting. As we have noted, Dobson’s nausea
and vomiting are disease-related and treatment-refractory, and the
hypothesized mechanism by which dronabinol works to relieve
nausea and vomiting is believed to be “perhaps by indirect inhibi-
tion of the vomiting center in the medulla as a result of binding to
opiate receptors in the forebrain”—a process that reasonably and
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28 Opinion of the Court 20-11996
fairly would be assumed to occur in disease-related cases of nausea
and vomiting generally.
We therefore vacate the entry of summary judgment for the
Secretary and remand with instructions to enter summary judg-
ment for Dobson because Dobson’s use of dronabinol to treat his
Central-Cord-Syndrome and Eagle-Syndrome-related refractory
nausea and vomiting is “supported by one or more citations in-
cluded or approved for inclusion” in DRUGDEX. 42 U.S.C. §
1396r-8(k)(6).
IV.
For these reasons, we VACATE the entry of summary judg-
ment for the Secretary and the denial of summary judgment for
Dobson and REMAND WITH INSTRUCTIONS to enter sum-
mary judgment for Dobson.
VACATED AND REMANDED.