Nat'l Home Infusion Ass'n v. Becerra
| Decision Date | 15 June 2021 |
| Docket Number | Civil Action No. 19-393 (TJK) |
| Parties | NATIONAL HOME INFUSION ASSOCIATION, Plaintiff, v. XAVIER BECERRA, in his official capacity as Secretary of Health and Human Services, Defendant. |
| Court | U.S. District Court — District of Columbia |
Plaintiff National Home Infusion Association (NHIA) is a nonprofit organization of member companies that provide home infusion medical services, which allow some patients to receive certain drugs at home instead of in a hospital. NHIA sues Defendant, the Secretary of Health and Human Services, alleging that his regulation defining "drug administration calendar day" under the relevant benefit program conflicts with the Medicare Act and violates the Administrative Procedure Act in several ways. The Secretary has moved to dismiss, arguing that the Court lacks subject-matter jurisdiction because NHIA's members have not exhausted their administrative remedies, and in the alternative, seeks summary judgment because the regulation is otherwise lawful. For the reasons explained below, the Court will dismiss the complaint because it lacks subject-matter jurisdiction.
The Medicare Act, 42 U.S.C. § 1395 et seq., establishes a program of health insurance for the elderly and the disabled. Under Medicare Part B, the federal government pays for certain outpatient infusion drugs that are "incident to" a physician's services, as long as the drugs are not usually self-administered by a patient. 42 U.S.C. § 1395x(s)(2)(A), (B). The Center for Medical Services (CMS), an agency housed within the Department of Human Health and Services (HHS), administers the Medicare program through private contractors known as Medicare Administrative Contractors (MACs). 42 U.S.C. §§ 1395u(a), 1395kk-1(a)(4).
Congress created a new Medicare benefit for home infusion therapy services in 2016. See 21st Century CURES Act, Pub. L. No. 114-255, § 5004, 130 Stat. 1033, 1190 (2016). That legislation authorized CMS to promulgate a payment scheme for certain items and services associated with home infusion therapy, effective January 1, 2021. See 42 U.S.C. § 1395m(u)(1)(A).
In later legislation, Congress instructed the Secretary of HHS ("the Secretary") to establish a temporary transitional benefit program to compensate eligible home infusion therapy suppliers for certain designated drugs until CMS established the permanent program. See Bipartisan Budget Act of 2018, Pub. L. No. 115-123, § 50401, 132 Stat. 64, 214 (2018). The Act specifically ordered the Secretary to "establish a single payment amount for each such payment category . . . for each infusion drug administration calendar day in the individual's home for drugs assigned to such category." 42 U.S.C. § 1395m(u)(7)(B)(iv). The Act also clarified that "a reference to payment to [an eligible home infusion supplier or a qualified home infusion therapy supplier] for an infusion drug administration calendar day in the individual's home shall refer to payment only for the date on which professional services [as described elsewhere in thestatute] were furnished to administer such drugs to such individual." 42 U.S.C. § 1395m(u)(7)(E)(i).
In devising the temporary transitional benefit program, the Secretary defined "infusion drug administration calendar day" as the "day on which home infusion therapy services are furnished by skilled professionals in the individual's home on the day of infusion drug administration." 42 C.F.R. § 486.505 ("Final Rule"); 83 Fed. Reg. 56,406, 56,579-583 (Nov. 13, 2018). Under the Final Rule, whether or not a professional is "skilled" turns on whether the services they provide are "so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel." Id.
National Home Infusion Association (NHIA) is a not-for-profit association that represents home infusion therapy companies. ECF No. 1 ¶ 11. Under Medicare, its members are reimbursed for medical services they provide to patients. Id. Three of NHIA's members—BioScrip, Inc., Intramed Plus, and Paragon Healthcare, Inc.—presented claims to the Secretary for Medicare reimbursement. Id. ¶ 13. BioScrip requested Medicare reimbursement from a MAC on February 7, 2019. ECF No. 15-1 ¶ 5. On February 13, 2019, Intramed Plus also presented claims to a MAC. Id.¶ 4. The next day, February 14, 2019, Paragon Healthcare presented its claims to a MAC. Id. ¶ 6. All three providers' claims sought "payment for days where the patient was infused but a nurse or other skilled professional was not present in the home." ECF No. 9-2 ¶¶10-14. All three sets of claims were denied. William Noyes, Senior Vice President of Reimbursement Policy at NHIA, submitted to the Court remittance notices dated between February 13 and February 21, 2019, which he asserts are "representative of the DME MAC's claims processing decisions" of NHIA's members' claims. ECF No. 15-1 ¶¶ 4-6. Most of the notices contain two codes explaining why the MAC denied the claim. See, e.g., id.at 11. The first code, M25, means that "[t]he information furnished does not substantiate the need for this level of service." Id. The second code, N180, signifies that the provided "item or service does not meet the criteria for the category under which it was billed." Id. A minority of the notices only contain the N180 code, see, e.g., id. at 12, but, like all the notices, they do not explain why the item or service did not meet the criteria for the category under which it was billed. NHIA filed a separate exhibit showing that of the fifty claims the three members submitted, forty-two led to remittance notices containing both codes and eight resulted in notices containing only the N180 code. ECF No. 9-2 at 118. NHIA represents that all three companies sought redetermination of the denied claims and that, at the time it moved for summary judgment, those appeals remained pending. ECF No. 15-1 ¶¶ 4-6.
NHIA filed this lawsuit on behalf of its members on February 14, 2019—within days of all three of its members' first request for reimbursement—alleging that the Final Rule conflicts with § 1395m(u)(7) of the Medicare Act and otherwise violates the Administrative Procedure Act. ECF No. 1. NHIA then moved for summary judgment, and Defendant moved to dismiss for lack of subject-matter jurisdiction, or in the alternative, for summary judgment. ECF No. 13. After the motions had been pending for about a year, the case was reassigned to the undersigned. See ECF No. 24.
"Federal courts are courts of limited jurisdiction." Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). The plaintiff bears the burden of establishing that the court has subject-matter jurisdiction. Colorado Heart Inst., LLC v. Johnson, 609 F. Supp. 2d 30, 34 (D.D.C. 2009) (citing Kokkonen, 511 U.S. at 377). In assessing whether a plaintiff has met its burden, "the Court must scrutinize the complaint, treating its factual allegations as true and granting the plaintiff the benefit of all reasonable inferences that can be drawn from those facts."Arriva Med. LLC v. U.S. Dep't of Health & Human Servs., 239 F. Supp. 3d 266, 276 (D.D.C. 2017). The Court may also "consider materials outside the pleadings in deciding whether to grant a motion to dismiss for lack of jurisdiction." Jerome Stevens Pharms., Inc. v. Food & Drug Admin., 402 F.3d 1249, 1253 (D.C. Cir. 2005) (citation omitted).
Under Federal Rule of Civil Procedure 56, a court must grant summary judgment "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). "Summary judgment is appropriately granted when, viewing the evidence in the light most favorable to the non-movants and drawing all reasonable inferences accordingly, no reasonable jury could reach a verdict in their favor." Lopez v. Council on Am.-Islamic Relations Action Network, Inc., 826 F.3d 492, 496 (D.C. Cir. 2016).
The Court begins, as it must, with the question of subject-matter jurisdiction. "Federal jurisdiction is extremely limited for claims arising under the Medicare Act." Porzecanski v. Azar, 943 F.3d 472, 480 (D.C. Cir. 2019). Three statutes lay out the scheme that governs judicial review of Medicare Act claims. "First, 42 U.S.C. §°405(h) divests the district courts of federal-question jurisdiction 'on any claim arising under' Title II of the Social Security Act, and it bars any 'decision of the Commissioner of Social Security' from being judicially reviewed, 'except as herein provided' in other Title II provisions." Am. Hosp. Ass'n v. Azar, 895 F.3d 822, 825 (D.C. Cir. 2018). Id. "Third, 42 U.S.C. §°1395ii states that certain provisions in § 405 and elsewhere in Title II'shall also apply with respect to' Title XVIII of the Social Security Act—i.e., the Medicare Act—'to the same extent as they are applicable with respect to' Title II, with any reference to the 'Commissioner of Social Security' considered as one to the Secretary of HHS." Id. "Although § 1395ii does not specifically enumerate § 405(g) as one of the incorporated Title II provisions," the Supreme Court and the D.C. Circuit have treated it as such, "presumably on the theory that expressly incorporating the judicial-review bar in § 405(h) also effectively incorporates the exception 'herein provided' in § 405(g)." Id.
The parties agree on a few aspects of their dispute that substantially narrow it. First, although federal question...
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