Opinion
CASE NO. 4:18-cv-10038-BECERRA
2020-03-31
Donald DOBSON, Plaintiff, v. Alex M. AZAR II, Secretary of the United States Department of Health and Human Services, Defendant.
Alice Bers, Pro Hac Vice, Wey-Wey Kwok, Pro Hac Vice, Center for Medicare Advocacy, Willimantic, CT, Kata Kertesz, Pro Hac Vice, Center for Medicare Advocacy, Washington, DC, Miriam E. Harmatz, Florida Health Justice Project, Miami, FL, for Plaintiff. Anthony Erickson-Pogorzelski, US Attorney's Office, Miami, FL, for Defendant.
Alice Bers, Pro Hac Vice, Wey-Wey Kwok, Pro Hac Vice, Center for Medicare Advocacy, Willimantic, CT, Kata Kertesz, Pro Hac Vice, Center for Medicare Advocacy, Washington, DC, Miriam E. Harmatz, Florida Health Justice Project, Miami, FL, for Plaintiff.
Anthony Erickson-Pogorzelski, US Attorney's Office, Miami, FL, for Defendant.
ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
JACQUELINE BECERRA, United States Magistrate Judge
THIS CAUSE came before the Court upon Plaintiff, Donald Dobson's ("Plaintiff" or "Dobson"), Motion for Summary Judgment, ECF No. [19], and Defendant, Alex M. Azar's ("Defendant" or "Secretary"), Cross-Motion for Summary Judgment, ECF No. [22]. Defendant and Plaintiff both filed their Responses, ECF Nos. [22] and [25], respectively, but only Plaintiff filed a Reply, ECF No. [25]. The Motions are now ripe for disposition. After careful review of the Motions, the relevant authorities, the record, and for the reasons discussed below, the undersigned ORDERS that Defendant's Motion for Summary Judgment, ECF No. [22], be GRANTED , and that Plaintiff's Cross Motion for Summary Judgment, ECF No. [19], be DENIED .
On February 7, 2019, parties consented to conduct any and all further proceedings in the case (including a trial) and order of entry of judgment before Magistrate Judge Jacqueline Becerra. ECF No. [28].
I. BACKGROUND
Plaintiff submitted a Statement of Material Facts, ECF No. [19-1], pursuant to Federal Rule of Civil Procedure 56(c), and Southern District of Florida Local Rule 56.1(a). Defendant failed to controvert Plaintiff's Statement of Material Facts as required by the Local Rules. Local Rule 56.1(b) provides: "[a]ll material facts set forth in the movant's statement filed and supported as required above will be deemed admitted unless controverted by the opposing party's statement, provided that the Court finds that the movant's statement is supported by evidence in the record." S.D. Fla. L.R. 56.1(b) (emphasis added). Because the Court finds that Plaintiff's Statement of Material Facts, ECF No. [19-1], is supported by the Certified Administrative Record, ECF No. [18], and has not been controverted, it is deemed admitted and incorporated in this section. See Kefeenie v. Gloria Martin Tr. , No. 17-24346-CIV-GAYLES/OTAZO-REYES, 2018 WL 4301558, at *4 (S.D. Fla. Sept. 10, 2018) ("Plaintiff has failed to properly controvert the Trust's Statement and, therefore, pursuant to Local Rule 56.1(b), all facts contained within that Statement are hereby deemed admitted.").
In August of 2009, Plaintiff Dobson was injured while working at a clinical hospital in Alaska. ECF No. [19-1] ¶ 1; R. at 0106, 0114, 0119, 1319–20. While trying to restrain a patient, he was crushed against a wall and suffered hyperflexion of his neck and spinal cord injury. Id. Plaintiff underwent two surgeries—one in September 2009 and one in December 2009. ECF No. [19-1] ¶ 2; R. at 0106, 0114, 0119, 1320. After the first surgery, Plaintiff developed symptoms of vomiting, frequent headaches, muscle spasms, severe neck pain and pain through his torso, impaired balance, sleep disturbance, and weight loss from decreased appetite. ECF No. [19-1] ¶ 3; R. at 0106, 0114, 0119–20. Plaintiff was also hospitalized multiple times in connection with "seizure-like (myoclonus) activity." Id.
References herein to "R. at ___" are to the Certified Administrative Record, the pertinent parts of which can be found at ECF No. [18]. All the page numbers refer to those found on the bottom right corner of the page.
Plaintiff moved to Florida in 2010 and has been receiving treatment since 2014 at the Rosomoff Comprehensive Rehabilitation Center in Miami for his symptoms of Central Cord Syndrome and Eagle's Syndrome. ECF No. [19-1] ¶ 5; R. at 0111, 0117, 0123-25, 1330. Plaintiff has also been diagnosed with autonomic dysreflexia, a form of dysautonomia that commonly occurs in individuals with spinal cord injuries characterized by episodes of significant elevations in blood pressure, sweating, muscle contractions, nausea, and cyclical vomiting. ECF No. [19-1] ¶ 8; R. at 0106, 0114, 0123–24, 1320–21. Plaintiff's persistent nausea and vomiting puts him at risk for serious medical complications, including stroke, increased blood pressure and seizures, as well as significant weight loss, increased muscle pain and muscle spasms. ECF No. [19-1] ¶ 9; R. at 0017, 0111–12, 1322–23, 1326, 1335.
According to the National Institute of Health, 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 (Mar. 27, 2019), https://www.ninds.nih.gov/Disorders/All-Disorders/Central-Cord-Syndrome-Information-Page. "The brain's ability to send and receive signals to and from parts of the body below the site of injury is reduced but not entirely blocked. Id. This syndrome is associated with damage to the large nerve fibers that carry information directly from the cerebral cortex to the spinal cord." Id.
According to the National Institute of Health, Eagle Syndrome is "characterized by recurrent pain the middle part of the throat (oropharynx) and face." Eagle syndrome , National Institute of Health (Apr. 18, 2017), https://rarediseases.info.nih.gov/diseases/9401/eagle-syndrome. It is "typically seen in patients after throat trauma or tonsillectomy." Id. "Eagle syndrome is due to a calcified stylohyoid ligament or an elongated styloid process. Id. The styloid process is a pointed part of the temporal bone that serves as an anchor point for several muscles associated with the tongue and larynx." Id.
After being given several medications for palliative treatment with no success, including suffering a serious allergic reaction to the medication Reglan (metoclopramide ), Plaintiff was given Marinol (a brand name of Dronabinol ) in October 2014. ECF No. [19-1] ¶ 12; R. at 0117, 0123–25, 1325–26. Plaintiff responded positively to the medication and his nausea and vomiting resolved shortly thereafter; Plaintiff noticed a reduction in his forearm and hand muscle spasms as well. ECF No. [19-1] ¶ 13; R. at 0111–12, 0117, 1324-1326.
B. Procedural History
Plaintiff has been a Medicare beneficiary, enrolled in a Medicare Part D prescription drug plan through UnitedHealthCare, during the time relevant to this appeal. ECF No. [19-1] ¶ 15; R. at 0032, 0223, 1065. On or around December 5, 2016, one of Plaintiff's physicians contacted Optum RX, Plaintiff's Medicare Part D prescription drug plan, seeking prior authorization of coverage for Plaintiff's Dronabinol prescription. ECF No. [19-1] ¶ 16; R. at 1102–05, 1219–21. After coverage was denied by OptumRX on December 8, 2016, Plaintiff's doctor filed an appeal with the UnitedHealthCare Medicare Part D Appeals and Grievance Department, which was thereafter denied because Plaintiff's use of Dronabinol was not for a "medically accepted indication" since it was not approved by the Food and Drug Administration ("FDA") for a use listed in at least one of the following: American Hospital Formulary Service-Drug Information ("AHFS-DI") or DRUGDEX. ECF No. [19-1] ¶¶ 17–19; R. at 0127–33, 1084–86, 1219-21.
Medicare Part D provides prescription drug coverage if the drug is used for a medically accepted indication. 42 U.S.C. § 1395w-102(e)(1). A "medically accepted indication" is defined as either "any use for a covered outpatient drug which is approved under the FDA," ("on-label" use) 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)" ("off-label" or "non-FDA-approved" use). Id. §§ 1395w-102(e)(4)(A)(ii), 1396r-8(k)(6). The Medicare-approved compendia include American Hospital Formulary Service-Drug Information ("AHFS-DI"), the United States Pharmacopeia-Drug Information ("USP-DI"), and the DRUGDEX Information System ("DRUGDEX"). Id. § 1396r-8(g)(1)(B)(i). The USP-DI is no longer in use.
Plaintiff, through counsel, appealed this denial on February 3, 2017. R. at 1081-83. On February 7, 2017, UnitedHealthCare upheld its coverage denial after a medical doctor's review of the information, stating that "Dronabinol is not FDA approved for nausea and vomiting related to Eagle Syndrome and Central Cord Syndrome." ECF No. [19-1] ¶ 20; R. at 1081–83. The denial further stated that as neither of these conditions [Eagle Syndrome or Central Cord Syndrome] is "one of the uses for the drug listed in AHFS-DI or [DRUGDEX] ... this drug is not a Medicare Part D drug." R. at 1081-83. It is undisputed that the use of Dronabinol to treat the symptoms of vomiting and nausea associated with Central Cord Syndrome and Eagle Syndrome is not an FDA-approved use. ECF No. [19-1] ¶ 19.
On April 4, 2017, Plaintiff, through counsel, filed a Reconsideration Request with MAXIMUS Federal Services, the Medicare Part D Independent Review Entity ("IRE"). ECF No. [19-1] ¶ 21; R. at 1076–80, 1205–09. Plaintiff received an unfavorable appeal decision on May 8, 2017 from the IRE stating that the Part D Plan is not required to cover Dronabinol to "treat an enrollee with nausea and vomiting related to Eagle [S]yndrome and [C]entral [C]ord [S]yndrome, not associated with cancer, chemotherapy, or following breast surgery, which are off-label (non-FDA) approved uses." R. at 1051-53, 1180-1188. Because the Medicare-approved compendia "do not contain any citations to support the use of this drug [Dronabinol ] for these conditions [of Eagle Syndrome and Central Cord Syndrome]," then "this drug is not being prescribed for a medically accepted indication as defined by Medicare law." R. at 1052, 1181. On June 30, 2017, Plaintiff requested a hearing before an Administrative Law Judge ("ALJ"). R. at 0220. A telephonic hearing was conducted on August 14, 2017. ECF No. [19-1] ¶ 22; R. at 0220–23, 1310–36. On September 26, 2017, after considering Plaintiff's brief, which included reference to a favorable and factually similar decision Tangney v. Burwell , 186 F. Supp. 3d 45 (D. Mass. 2016), testimony regarding his condition and palliative use of Dronabinol, and statements from Plaintiff's doctors, the ALJ agreed with the IRE's decision that coverage of Plaintiff's use of Dronabinol should be denied. ECF No. [19-1] ¶ 23; R. at 0152, 1310–36. Specifically, the ALJ concluded that "Dronabinol is not approved by the FDA for [Plaintiff]’s medical condition or indicated by the appropriate compendia [AHFS-DI or DRUGDEX] as accepted for treatment of [Plaintiff]’s medical condition." ECF No. [19-1] ¶ 23; R. at 0152.
Although the ALJ also concluded that "Dronabinol is not medically reasonable and necessary under [42 U.S.C. § 1395(y)(1)(A) ] for the treatment of [Plaintiff]’s symptoms of nausea and vomiting related to Eagle Syndrome or Central Cord Syndrome," the Council agreed with the parties that the medical necessity and reasonableness of the drug was not in dispute. R. at 0006, 0011.
Plaintiff appealed the ALJ's decision to the Medicare Appeals Council ("Council") on November 15, 2017. ECF No. [19-1] ¶ 24; R. at 0013-138. In his appeal, Plaintiff argued that the ALJ erred as a matter of fact and law in two main regards. R. at 0005. First, the ALJ disregarded Plaintiff's detailed argument that Plaintiff's Dronabinol prescription is for a medically accepted indication since the use of Dronabinol to treat Plaintiff's nausea and vomiting is directly supported by the DRUGDEX entries titled "Nausea and vomiting, Disease-related, treatment refractory" as well as "Postoperative nausea and vomiting; Treatment and Prophylaxis." Id. Second, Plaintiff argued that the ALJ ignored a factually similar case, Tangney , in holding that for palliative care, the "medically accepted indication" determination for Part D coverage was based on the symptoms of the condition and not on the underlying disease causing the symptoms. R. at 0006.
Council subsequently upheld the ALJ's conclusions on February 12, 2018. R. at 0003–11. Council disagreed with Plaintiff's first argument that the Dronabinol prescription was for a medically accepted indication because the standard requires a use of a Part D drug to be "supported by one or more citations" in DRUGDEX or AHFS-DI. R. at 0008; see 42 U.S.C. § 1396r-8(k)(6). Council posited that if they "accept[ed Plaintiff]’s assertion that the DRUGDEX citation at issue should be read broadly based on its title, the actual content of the citation, and all other DRUGDEX citations, would be rendered superfluous." R. at 0008. In short, Council concluded that "the text of the title does not override the content of the citations" and rejected Plaintiff's assertion that this DRUGDEX entry directly supported the use of Dronabinol to treat nausea and vomiting related to Central Cord Syndrome and Eagle Syndrome. R. at 0009. Council also rejected Plaintiff's argument that the Dronabinol prescription was covered under the DRUGDEX citation "Postoperative nausea and vomiting; Treatment and Prophylaxis" because the medical record did not reflect that the symptoms of Plaintiff were postoperative in nature. R. at 0010. Council then disagreed with the holding in Tangney , stating that Council was not bound by the federal district court case and that they "[did] not accept that a coverage determination involving the ‘medically accepted indication’ standard can turn on an enrollee's symptoms alone." R. at 0010. To provide further support for this conclusion, Council cited to the Prescription Drug Benefit Manual ("PDBM"), concluding that a medically accepted indication refers to "the diagnosis or condition for which a drug is being prescribed." R. at 0010; 100-18, Medicare Prescription Drug Benefit Manual , CENTER FOR MEDICARE AND MEDICAID SERVICES , Chapter 6 § 10.6 (Jan. 15, 2016) [hereinafter "PDBM"] (emphasis added). After exhausting the administrative remedies available, Plaintiff filed the Complaint on April 6, 2018, pursuant to 42 U.S.C. § 1395w-104(h)(1), incorporating the requirements of § 1395w-22(g)(5) and § 405(g). ECF No. [1].
C. The DRUGDEX Citation
The parties agree that the relevant portion in the DRUGDEX compendia is the citation for the use of Dronabinol under the title "Nausea and vomiting, disease-related, treatment refractory." ECF No. [19] at 3; R. at 0046–81. Specifically, the DRUGDEX compendia lists two FDA approved, or on-label, uses and six non-FDA approved, or off-label, uses for the medication Dronabinol. R. at 0047–53. For each cited use, the DRUGDEX entry contains an overview reflecting whether the FDA has approved Dronabinol for that particular use, its efficacy, grade of recommendation, and strength of evidence ratings. Id. Each indication also includes a summary of the support for the particular use, ranging from case reports for some uses to double-blind, multicenter, clinical trials for other uses. Id. The two FDA-approved uses of Dronabinol are for "AIDS – loss of appetite" and "Chemotherapy-induced nausea and vomiting, in patients with inadequate response to conventional antiemetic treatments." R. at 0048–49. The six cited off-label uses are for "Gilles de la Tourette's syndrome," "Loss of appetite, cancer-related," "Multiple sclerosis – Spasticity," "Postoperative nausea and vomiting; Treatment and Prophylaxis," "Pruritis, Cholestasis-associated, treatment refractory," and "Nausea and Vomiting, Disease-related, treatment refractory." R. at 0050–53.
Plaintiff does not argue before this Court, as it did before the ALJ, that the DRUGDEX citation "Postoperative nausea and vomiting; Treatment and Prophylaxis" supports Plaintiff's Dronabinol prescription.
Here, the off-label use "Nausea and Vomiting, Disease-related, treatment refractory" is the one at issue. Under the title "Nausea and vomiting, disease-related, treatment refractory," there is one case-study related to the treatment of symptoms for a patient suffering from metastatic cancer of the gastrointestinal mucosa. R. at 0051–52. In that case-study, the patient's symptoms were lessened, but not completely relieved, when Dronabinol was taken in combination with three other drugs. Id. The case study is limited to the metastatic cancer of the gastrointestinal mucosa, and as such, makes no mention of Central Cord Syndrome or Eagle Syndrome. Id. As discussed below, the parties dispute whether this provision authorizes Medicare Part D coverage for off-label use to treat disease related nausea and vomiting that, as in Plaintiff's case, is unrelated to metastatic cancer of the gastrointestinal mucosa.
II. ANALYSIS
Summary judgment is appropriate where there is "no genuine issue as to any material fact [such] that the moving party is entitled to judgment as a matter of law." Celotex Corp. v. Catrett , 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ; see also Fed. R. Civ. P. 56(a). In this case, the parties do not dispute the facts; instead, the issue is whether Council correctly determined that Plaintiff's use of Dronabinol was not prescribed for a "medically accepted indication" because it failed to meet the definition for an off-label use, "which is supported by one or more citations included or approved for inclusion in any of the compendia described in [ 42 U.S.C. § 1396r-8(g)(1)(B)(i) ]." See 42 U.S.C. § 1396r-8(k)(6).
Judicial review of an administrative decision regarding a claim for Medicare benefits is authorized by 42 U.S.C. § 405(g), as incorporated into the Medicare statute by 42 U.S.C. § 1395w-22(g)(5) and 104(h)(1). The text of § 405(g) establishes the standard of review for these claims when it states, in pertinent part, that "[t]he findings of the [agency] as to any fact , if supported by substantial evidence, shall be conclusive." (emphasis added). Therefore, "judicial review of the Secretary's decision regarding a claim for Medicare benefits is limited to ‘whether there is substantial evidence to support the findings of the ... [Secretary], and whether the correct legal standards were applied.’ " Gulfcoast Med. Supply v. Sec'y, Dep't of Health & Human Servs., 468 F.3d 1347, 1350 n.3 (11th Cir. 2006) (quoting Wilson v. Barnhart , 284 F.3d 1219, 1221 (11th Cir. 2002) ). "If the Secretary's decision is supported by substantial evidence such that a reasonable mind might accept it as adequate to support her conclusion and the correct legal standards were applied, the Court must affirm the Secretary's decision." CompRehab Wellness Grp., Inc. v. Sebelius , No. 11-23377-CIV, 2013 WL 1827675, at *4 (S.D. Fla. Apr. 30, 2013).
The issue at hand is whether Plaintiff's "off-label" use of Dronabinol is covered by Medicare Part D. Specifically, whether the interpretation of the phrase "the use of which is supported by one or more citations included or approved for inclusion in any of the compendia" as contained in the definition of the term "medically accepted indication," see 42 U.S.C. §§ 1395w-102(e)(4)(A)(ii) and 1396r-8(k)(6), should be read to include the off-label use that Plaintiff proposes.
Plaintiff argues that the DRUGDEX entry squarely supports his use of Dronabinol. He contends that the heading "Nausea and Vomiting, Disease-related, treatment refractory" in the DRUGDEX compendium is self-explanatory, and that the study supporting this use of Dronabinol in the DRUGDEX citation should not limit its application to only individuals with gastrointestinal mucosal metastases but should be interpreted broadly to support the use of Dronabinol for other palliative treatments. ECF No. [19] at 10; ECF No. [25] at 5. Plaintiff contends, that like the patient in the citation's case study, he suffers from "Nausea and Vomiting, Disease-related, treatment refractory," and that like the patient in the study, his condition is resolved only with the use of the drug. ECF No. [19] at 9. Specifically, Plaintiff argues that: (1) if the Congress had wanted to limit this indication to gastrointestinal mucosal metastases, it would have stated as such in the title, as it has done for other off-label uses of Dronabinol, e.g. "Pruritis, Cholestasis-associated, treatment refractory;" and (2) the citation directly supports Plaintiff's use of Dronabinol because, like other patients in the study, Plaintiff requires the prescription for palliative treatment of his nausea and vomiting, and as such, "[p]arity between the underlying diagnoses is not relevant. ECF No. [19] at 10. In addition, Plaintiff urges this Court to give no deference to the Council's decision, but rather examine the case anew, on the grounds that the ECF [19] at 14.
In contrast, Defendant argues that Council's decision was correct and should receive deference under the standard articulated in Chevron U.S.A. v. Natural Resources Defense Council, Inc. , 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), or at the very least, the standard articulated in Skidmore v. Swift & Co. , 323 U.S. 134, 65 S.Ct. 161, 89 L.Ed. 124 (1944). ECF No. [22] at 12–13. Using the deference provided for in Skidmore , Defendant argues that the Council's opinion, due to its thoroughness in consideration, validity in reasoning, and consistency in rejecting the expansive interpretation sought by Plaintiff, should be affirmed. Specifically, Defendant argues that Council's decision was correct because the DRUGDEX title cannot be read independently of the study that is described in the section of the title at issue. Id. at 13. As such, because there is no suggestion in the citation that Dronabinol is applicable to Plaintiff's conditions, his off-label use should not be covered by Medicare.
A. Council's Interpretation Should Be Afforded Skidmore Deference.
As an initial matter, the Court must determine what level of deference, if any, to apply to Council's determination. On the one hand, Plaintiff argues that no deference—neither the standard articulated in Chevron , nor the standard articulated in Skidmore —should be afforded to the agency's decision because Defendant's unduly restrictive interpretation of what constitutes a "medically accepted indication" is erroneous as a matter of law. ECF No. [19] at 8, 13–14. Specifically, Plaintiff contends that the off-label use at issue is supported by a citation in the DRUGDEX compendia, and as such, should be covered under the controlling statutory law. Id. at 15-16. In arguing that Chevron deference is inapplicable, Plaintiff contends that the Secretary's decision is not a formal exercise of rulemaking powers but was merely a decision by a single Council adjudicator at the final level of administrative review for an individual claim. Id. at 13. As such, Plaintiff argues that Chevron is inapplicable. As to Skidmore deference, Plaintiff argues that Council's decision lacks thoroughness in consideration because it erroneously concludes that Plaintiff's off-label use was not supported by the citation in the DRUGDEX compendia simply because Plaintiff did not have the same underlying diagnosis as the patient that was the subject of the study noted in the citation. ECF No. [19] at 14. Defendant contends that, at a minimum, Skidmore deference is warranted because Council ruled in a manner consistent with previous Council rulings on the same or similar issues, Plaintiff was given the full benefits of the multi-step Medicare administrative appeals process, and Council provided a thorough and clear reasoning to support its decision. ECF No. [22] at 12-13.
The Court declines to apply Chevron deference. Chevron deference is applicable in cases where the statute is silent or ambiguous with respect to a specific issue, and the interpretation of the agency is promulgated pursuant to a Congressional delegation of authority to make rules that carry the force of law. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc. , 467 U.S. 837, 842–843, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). As the Supreme Court explained in United States v. Mead Corp. , 533 U.S. 218, 226–227, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001), "an administrative implementation of a particular statutory provision qualifies for Chevron deference when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority." Here, Congress did not delegate authority to the Secretary "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. Indeed, the statute at issue is not silent or ambiguous, and the agency's decision is not the product of a formal agency process, nor is its decision one that has precedential value beyond the facts and parties.
Instead, the Court finds that the agency's decision should be afforded Skidmore deference. Under Skidmore deference, an agency's statutory interpretation receives deference "corresponding to the ‘thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control.’ " Martin v. Soc. Sec. Admin., Comm'r , 903 F.3d 1154, 1159 (11th Cir. 2018) (citing Skidmore v. Swift & Co. , 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944) ); see also Goodson v. OS Rest. Servs., LLC , No. 5:17-CV-10-OC-37PRL, 2017 WL 1957079, at *3 (M.D. Fla. May 11, 2017) (noting that, under Skidmore , courts defer to an agency's interpretation "only to the extent that such pronouncements have the "power to persuade," which turns on the " Skidmore Factors"). This deference recognizes an agency's specialized experience and information-seeking capacities, as well as the value of uniformity. Id. ; see Mead, 533 U.S. at 234–35, 121 S.Ct. 2164.
Here, Council's decision—as an agency interpretation—merits analysis under Skidmore . Medicare law is complex, and as such, Council has the power to persuade because it is certainly in a better position to evaluate questions involving subject matter that are technical, complex, and dynamic. See generally Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Services. , 545 U.S. 967, 1002–03, 125 S.Ct. 2688, 162 L.Ed.2d 820 (2005). Therefore, Council's decision should be reviewed with Skidmore deference, and as such, be evaluated on its "power to persuade," considered in light of "its writer's thoroughness, logic, and expertness, its fit with prior interpretations, and any other sources of weight." Mead , 533 U.S. at 235, 121 S.Ct. 2164 ; see Martin , 903 F.3d 1154 (recognizing an "agency's specialized experience and information-seeking capacities, as well as the value of uniformity," merits an agency's statutory interpretation receiving, "at minimum," deference under Skidmore ); Arriaga v. Florida Pacific Farms, L.L.C. , 305 F.3d 1228, 1238 (11th Cir. 2002) (determining that the district court should have, at a minimum, considered the Department of Labor's interpretations expressed in the opinion letters and viewed these through the standard enunciated in Skidmore ); see also Pugliese v. Pukka Dev., Inc. , 550 F.3d 1299, 1305 (11th Cir. 2008) (concluding that the Department of Housing and Urban Development's interpretation of the Interstate Land Sale Act should be afforded Skidmore deference); Durr v. Shinseki , 638 F.3d 1342, 1350 (11th Cir. 2011) (affording Skidmore deference to the Department of Veterans Affairs’ interpretation of the probationary period under 38 U.S.C. § 7403(b)(1) because it was based on a "longstanding interpretive framework"). Indeed, while Skidmore deference does not "override" a court's reading of the provision's plain meaning, it informs a court's interpretation of any text that is more difficult to untangle. Martin , 903 F.3d. at 1163.
The Court is unpersuaded by Plaintiff's challenge to Skidmore deference. It appears that Plaintiff is simply arguing that because he disagrees with the Council's decision the decision lacks thoroughness of consideration. ECF No. [19] at 14. However, an agency's decision can be incorrect, yet still be deserving of Skidmore deference. See Arriaga , 305 F.3d at 1238–39 (finding that Skidmore analysis was warranted even though the court ultimately concluded that the opinion letters were unpersuasive because they lacked sufficient explanation to weigh the validity of its reasoning or the thoroughness of consideration). For the reasons noted above, the Court here will use Skidmore deference in reviewing Council's decision.
B. Council's Interpretation Is Thorough And Consistent With Prior Interpretations.
In deciding that Plaintiff's use of Dronabinol did not qualify as a "medically accepted indication," Council considered the language of the DRUGDEX citation and found that the title of the citation must be read together with the content of the citation. R. at 0009. The Council noted that although the title of the citation "on its face seems to provide support" for Plaintiff's use of the drug, the Council based its reasoning on the fact that the statute requires the use of a covered Part D drug to be "supported by one or more citations included or approved for inclusion." R. at 0008 (citations omitted). In short, the medical use at issue needed to be supported by a citation, and more particularly, a full reading of the citation. Id. Indeed, to rely on the title alone would render "the actual content of this citation" and superfluous." Id.
This Court agrees with Council's interpretation. Although the DRUGDEX compendia at issue is titled "Nausea and vomiting, Disease-related, treatment refractory," our analysis cannot stop there. The citation at issue is not particularly long or complex and a review of it (which the Council undertook) is instructive, if not dispositive. The citation contains the title, followed by an "Overview" section that notes the FDA's approval, efficacy, recommendation, strength of evidence and "drug consult reference." R. at 0051–52. The Overview section does not shed light, by the undersigned's reading, to the issues at hand. The Overview is followed by a "Summary" that reads "intractable nausea and vomiting related to metastatic cancer of the gastrointestinal mucosa resolved only after addition of tetrahydrocannabinol." Id. That section is followed by the section entitled "Adult" which summarizes a study of the effect of the drug on a man with metastatic cancer. Id. The full study, as noted in the footnote to the section, is titled "Intractable nausea and vomiting due to gastrointestinal mucosal metastases relieved by tetrahydrocannabinol (Dronabinol )." Id. at 0076. Reading the entire citation makes clear that the it applies to cases where patients are suffering from metastatic cancer of the gastrointestinal mucosa. To apply it to any case where a patient has nausea and vomiting related to any disease is simply not support by the plain reading of the citation. In short, Plaintiff's argument that the Medicare statute and DRUGDEX compendia should be interpreted broadly such that any palliative use of Dronabinol that falls under the title should be covered is unpersuasive as it would render the remainder of the citation superfluous. Council also addressed Plaintiff's argument that the drafters of DRUGDEX could have included specific language in the title limiting the use of Dronabinol for "Nausea and Vomiting, Disease-related, treatment refractory," a limitation found in other citations, to individuals with gastrointestinal mucosal metastases if that is what it intended. R. at 0009. The Council was unpersuaded by his argument. The Council noted the variance in the titles and concluded that this "shows that the text of the title does not override the content of the citation." Id. Here, too, the Court is not persuaded that the failure to incorporate the disease in the title evidences intent to include a broader range of diseases. That reading, as noted above, would render the remainder of the citation to be superfluous. Perhaps, as Defendant observes, it is possible that at some point in the future DRUGDEX "may add other citations to other studies confirming other uses of Dronabinol in the treatment of intractable nausea and vomiting;" however, at the present time there is only this citation, which relates only to metastatic cancer of the gastrointestinal mucosa. ECF No. [22] at 10 n.4.
Indeed, as a matter of statutory construction such a reading would be suspect. A statute should be interpreted "so that no words shall be discarded as being meaningless, redundant, or mere surplusage ... [i]t is [the court's] duty to give effect, if possible to every clause and word of a statute rather than to emasculate an entire section." United States v. Canals–Jimenez , 943 F.2d 1284, 1287 (11th Cir. 1991) (internal citation omitted). Moreover, "statutory language must be read in the context of the purpose it was intended to serve." United States v. Ballinger, 395 F.3d 1218, 1237 (2005). "[N]othing is better settled than that statutes should receive a sensible construction, such as will effectuate the legislative intention, and, if possible, so as to avoid an unjust or absurd conclusion." Id. (quoting In re Chapman , 166 U.S. 661, 667, 17 S.Ct. 677, 41 L.Ed. 1154 (1897) ) (alteration in original). Notably, section headings cannot limit the plain text of the text, rather section headings "are tools available for the resolution of a doubt about the meaning of a statute." Fla. Dept. of Revenue v. Piccadilly Cafeterias, Inc. , 554 U.S. 33, 47, 128 S.Ct. 2326, 171 L.Ed.2d 203 (2008) (citing Porter v. Nussle , 534 U.S. 516, 528, 122 S.Ct. 983, 152 L.Ed.2d 12 (2002) ) (internal quotation marks omitted).
In addition, Council supported its decision with a discussion of the PDBM, a Medicare manual which does not carry the force of law but still clarifies what "medically accepted indication" entails. R. at 0010. The PDBM sets forth interpretive rules meant to "advise the public of the agency's construction of the statutes and rules which it administers." Azar v. Allina Health Servs. , ––– U.S. ––––, 139 S. Ct. 1804, 1811, 204 L.Ed.2d 139 (2019) (quoting Perez v. Mortgage Bankers Ass'n , 575 U.S. 92, 97, 135 S.Ct. 1199, 191 L.Ed.2d 186 (2015) ). Although the PDBM does not bind ALJs and the Council, they must be accorded substantial deference if they are applicable to a particular case. See 42 C.F.R. § 423.2062(a). The PDBM states that a "medically accepted indication" refers to "the diagnosis or condition for which a drug is being prescribed." PDBM, Ch. 6 § 10.6. The PDBM's explanation is not in conflict with the statutory definition, rather it further clarifies the meaning of the statute. Here, Plaintiff's "diagnosis" or "condition" is Central Cord Syndrome or Eagle's Syndrome and Dronabinol was prescribed to treat the symptoms of nausea and vomiting associated with Plaintiff's condition and not the condition itself. This Court finds Council's opinion to be thorough and logical, based on a sound reading of the plain language of the citation, as well as supported by the agency's own interpretive materials.
Next, the Court finds that the Council's decision is also consistent with its prior rulings. Council's opinion is consistent with previous Council decisions where expansive interpretations of DRUGDEX citations were rejected. In In the Case of K.S. , Council evaluated whether "Medicare Part D prescription drug plan ... cover[ed] the enrollee's dronabinol (brand name Marinol), 5 mg capsules, prescribed to relieve nausea associated with diabetes-induced gastroparesis." No. M-11-9558, 2011 WL 6901437, at * 1 (Medicare Appeals Council Apr. 29, 2011). Council concluded that use of Dronabinol was not supported by the DRUGDEX heading because the DRUGDEX citation included a sub-section specifying the applicability only to metastatic cancer of the gastrointestinal mucosa. Id. at *5. Council explained that although "DRUGDEX includes several citations on the ‘off-label’ use of dronabinol, including those for the purposes of controlling nausea and vomiting, [DRUGDEX] does not address nausea and vomiting associated with diabetes-induced gastroparesis." Id. at *4. Furthermore, Council explained that "the ALJ's broad interpretation of the DRUGDEX evaluation for dronabinol, by extension, could support the use of dronabinol for virtually any underlying disease, so long as nausea and vomiting are stated as symptoms of that disease." Id. at * 6. This interpretation is entirely consistent with the findings of Council in the instant case.
Likewise, in In the Case of M.M. , the ALJ and Council both affirmed the denial of Part D coverage for the off-label use of Lidoderm to treat pain arising from osteoarthritis with back pain, fibromyalgia, and post/status mastectomy. No. M-12-369, 2012 WL 889396, at * 1, 4 (Medicare Appeals Council Feb. 2, 2012). Council explained that that the enrollee's use was not supported because the use approved by the DRUGDEX citation "is associated with treatment of oral conditions, and is not related to any of the [enrollee]’s diagnoses." Id. at *4. Council's interpretation in In the Case of M.M. , is consistent with its interpretation in this case. Plaintiff attempts to draw a distinction between In the Case of M.M. and the instant case by arguing that the heading there only offered a description of the drug where as here the title identifies a medically accepted indication. ECF No. [25] at 9. The Court disagrees. In both cases the headings provided in the DRUGDEX were more general that the citations themselves and more general than the use the Council approved.
Finally, in In the Case of L.G. , Council held that the enrollee's use of Ondansetron to treat nausea and vomiting associated with chronic intestinal pseudo-obstruction and gastrointestinal/bowel dysmotility was not sufficiently covered in the DRUGDEX compendia. No. M-11-691, 2011 WL 6412182, at *3 (Medicare Appeals Council April 7, 2011). Council reversed the ALJ's decision and stated that the DRUGDEX compendia only supported a use of Zorfan (Ondansetron ) with "a case report ... suggesting a role for Ondansetron in treating fatigue from chronic liver disease" and "a study of Ondansetron's use in treating acute gastroenteritis in children." Id. The case report for Ondansetron in treating fatigue from chronic liver disease notes that "additional study is needed to document efficacy." Id. Here, Plaintiff attempts to distinguish the facts of In the Case of L.G. , stating that the enrollee in that case relied on cited case studies that were clearly inapplicable. ECF No. [25] at 8. This Court is again unpersuaded because, as in this case, Council in In the Case of L.G. declined Part D coverage because there was no approved compendia that included "citations supporting the use of [the] drug for the treatment of nausea and vomiting ... as it has been prescribed for the enrollee." 2011 WL 6412182, at *3.
Plaintiff also argues that the Secretary's decision to impose a restrictive standard for an off-label use of a drug prescription is inconsistent with Edmonds v. Levine , 417 F. Supp. 2d 1323 (S.D. Fla. 2006). ECF No. [19] at 16. In Edmonds , the Florida State Medicare Agency ("AHCA"), refused to cover prescriptions for the off-label use of the drug Neurontin cited in DRUGDEX unless the use was supported by double-blind, placebo-controlled, or randomized clinical trial. 417 F. Supp. 2d at 1334–35. The District Court in Edmonds concluded that, in imposing such a requirement, the AHCA was adding its own new ad hoc standard to a Federal law in order to exclude Neurontin from Medicare coverage. Id. at 1341. In short, by requiring more than the Federal law required, the state agency was "substituting its own judgment for that of Congress" in applying a more stringent test than Congress intended. Id. at 1337, 1339 ; see Pub. L. No. 103-66, § 13602(a)(2)(B)(iii), 107 Stat. 312, 619 (1993).
In Edmonds , AHCA's Bureau Chief for the Pharmacy Services Bureau in Medicaid testified that "Florida could have used a different standard from the one it now uses, and he acknowledged that coverage of a particular drug for a particular use could vary from state to state." 417 F. Supp. 2d at 1338. The District Court noted that AHCA was "deciding on its own what is ‘supported by citation,’ as evidenced by its decision to pay for two of the three uses [for Neurontin ] which are listed as ‘ineffective’ ... and to not pay for others that are listed as ‘effective.’ " Id.
In this case, Council did not apply an ad hoc or arbitrary application of the Medicare prescription drug coverage determination. Instead, Council decided whether the use of Dronabinol was supported by one or more citations, and in doing so, applied principles of statutory interpretation to conclude that the DRUGDEX citation at issue did not. The Council here did not use an ad hoc process to conclude that the citation did not apply, and as such, the reasoning in Edmonds simply does not apply.
Plaintiff further argues that the District Court for the District of Massachusetts's decision in Tangney , 186 F. Supp. 3d 45, supports its argument that Medicare Part D must cover his Dronabinol prescription. ECF No. [19] at 15. The plaintiff in Tangney was similar to Plaintiff in that both suffered from severe vomiting and nausea that was alleviated through the use of Dronabinol, and neither had metastatic gastrointestinal cancer. 186 F. Supp. 3d at 46. The Part D program "denied coverage on the ground that the off-label use prescribed to Tangney was not "supported by one or more citations in [approved] ... compendia[.]" Id. (quoting 42 U.S.C. § 1396r–8(k)(6) ) (alterations in original). The administrative law judge disagreed and granted coverage. Id. Thereafter, the Medicare Appeals Council reversed, concluding that the plaintiff's use of Dronabinol was not supported by DRUGDEX because the titles in DRUGDEX were "analogous to labels on file folders" and that a broad sounding title could reflect that "indications will be recommended based on citations as the [scientific] literature develops." Id. at 51 (alterations in original). The Tangney Council also observed that there was nothing in the case study supporting the use of Dronabinol to treat other "non-identically-diagnosed patients." Id.
The district court, "[a]pplying Skidmore deference to the substantive issue of whether Tangney's use of Dronabinol is ‘supported by’ a citation in Drugdex, [concluded that] the Council's reasoning [was] unpersuasive, and h[eld] that Tangney's use of Dronabinol, because palliative, [was] supported by the citation in Drugdex to a case study of a patient with the same symptoms." Id. at 51–52. The district noted that its decision turned on "whether the agency has consulted appropriate sources, employed sensible heuristic tools, and adequately substantiated its ultimate conclusion.’ " Id. at 56 (quoting Doe v. Leavitt , 552 F.3d 75, 82 (1st Cir. 2009) ). The district court explained that although the Council consulted appropriate sources (the DRUGDEX entry, the underlying case study, and the Council's previous decisions) and utilized heuristic devices (rejecting the hearing officer's broad interpretation of the DRUGDEX citation), the Council did not adequately substantiate its conclusion. Id. The district court explained that the Council's decision, while internally consistent, failed to provide an explanation as to why the citation's failure to include Tangney's prescribed use for Dronabinol precluded Part D coverage. Id. at 57.
Here, the Court is unpersuaded by the non-binding Tangney decision. Tangney is distinguishable because unlike the Tangney Council, Council here set forth an adequate reasoning for its denial of Part D coverage for Plaintiff's Dronabinol prescription. By contrast, the Tangney Council made findings with respect to the underlying case study and then relied on that in determining that the palliative use of the drug was supported by the title of the citation. The Council in this case concluded that Part D did not afford coverage in Plaintiff's case because the Dronabinol prescription was not "supported by one or more citations," relied on the PDBM, and then specifically addressed Plaintiff's arguments, including the argument that the reasoning in the Tangney decision should apply. In short, although the cases are similar, the reasoning of Council in the respective cases was different. Moreover, as Plaintiff and Defendant point out, the Tangney court was clearly compelled by the facts of that case. ECF Nos. [19] at 15, [22] at 14. Here, the facts are also quite poignant. However, the Council's decision here provided a different framework, one that requires affirmance.
III. CONCLUSION
Accordingly, it is hereby ORDERED AND ADJUDGED that Plaintiff's Motion for Summary Judgment is DENIED , and Defendant's Cross Motion for Summary Judgment is GRANTED .
DONE AND ORDERED in Chambers at Miami, Florida, this 31st day of March, 2020.