Dobson v. Sec'y of Health & Human Servs.
| Decision Date | 11 February 2022 |
| Docket Number | 20-11996 |
| Parties | DONALD DOBSON, Plaintiff-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Defendant-Appellee. |
| Court | U.S. Court of Appeals — Eleventh Circuit |
DONALD DOBSON, Plaintiff-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, Defendant-Appellee.
No. 20-11996
United States Court of Appeals, Eleventh Circuit
February 11, 2022
DO NOT PUBLISH
Appeal from the United States District Court for the Southern District of Florida D.C. Docket No. 4:18-cv-10038-JB
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 medications. 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 "medically 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-related 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 approved medical compendium tends to show or helps prove the efficacy and safety of the prescribed off-label use. Because the use of dronabinol to relieve refractory, disease-related nausea and vomiting satisfies that standard, we vacate the district court's entry of summary judgment for Appellee Secretary of Health and Human
Services and its denial of summary judgment for Dobson and remand 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-insurance 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 prescription 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 administer Medicare Part D, the Centers for Medicare & Medicaid Services ("CMS"), a part of the U.S. Department of Health and Human Services, contracts with private insurers, called "plan sponsors," to provide prescription drug coverage to Medicare beneficiaries 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
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 reimbursements 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 prescription 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 Federal 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 "supported 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 compendia are "large reference books that contain a variety of information about the prescription pharmaceuticals currently available
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 compendia 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 artificial disk in his spinal cord. A couple months later, in December 2009, Dobson underwent a second surgery to fix some of the "hardware" that doctors had implanted in September.
Based on his injury and related surgeries, Dobson was diagnosed 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, 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 recurrent pain in the middle part of the throat . . . and face." Eagle
Syndrome, National Institute of Health (Apr. 18, 2017), https://ra-rediseases.info.nih.gov/diseases/9401/eagle-syndrome (last visited 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 dangerously high blood pressure, excessive sweating, nausea, and cyclic 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 persistent nausea and vomiting because the usual drugs used to treat those symptoms would not work. Dobson even had a severe allergic reaction to one of the medications-Reglan (metoclopramide). Eventually, his doctors prescribed Marinol (a brand name of dronabinol).
The medication worked almost immediately, and Dobson's symptoms subsided. Dobson's doctor, Dr. Shaun C. Corbett, described 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 particular 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 inadequate response to conventional antiemetic treatments."
The DRUGDEX compendium also lists six non-FDA approved (off-label) uses. As relevant here, one of those listed uses is for "[n]ausea and vomiting, [d]isease-related, treatment refractory."
That citation has three main components: the title (noted above), the "Overview" section, and the "Summary" section.
The "Overview" section provides (1) information on efficacy, (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 information about the scientific study or evidence that provides the basis for the citation. It states that "[i]ntractable nausea and vomiting related to metastatic cancer of the gastrointestinal mucosa resolved only after addition of...
To continue reading
Request your trial