Kantor v. Azar

CourtDistrict Court, D. Maryland
DecidedMarch 25, 2021
Docket1:20-cv-02475
StatusUnknown

This text of Kantor v. Azar (Kantor v. Azar) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Kantor v. Azar, (D. Md. 2021).

Opinion

FOR THE DISTRICT OF MARYLAND

: RUTH E. KANTOR, M.D., :

v. : Civil Action No. DKC 20-2475

: XAVIER BECERRA,1 in his official capacity as Secretary : of the Department of Health and Human Services :

MEMORANDUM OPINION Presently pending and ready for resolution in this action for judicial review of an adverse agency decision is Defendant’s Motion to Dismiss (ECF No. 12). The issues have been fully briefed, and the court now rules, no hearing being deemed necessary. Local Rule 105.6. For the following reasons, the motion to dismiss will be denied and the parties will be directed to show cause why the case should not be remanded. I. Background The following facts are derived from the administrative record preceding this appeal and the pleadings. A. The Statutory and Regulatory Framework Medicare is a federally funded health insurance program for the elderly and disabled. It is governed by Title XVIII of the

1 The complaint named Alex M. Azar, former Secretary of Health and Human Services (“HHS”) as Defendant. (ECF No. 1). As of the time of the filing of this opinion, Xavier Becerra now serves as HHS Secretary (“Secretary”). Pursuant to Fed.R.Civ.P. 25(d), Secretary Becerra is automatically substituted as a party to this Centers for Medicare & Medicaid Services (“CMS”) of the United States Department of Health and Human Services (“HHS”) is responsible for administering the Medicare Program, which consists of four basic parts, Parts A through D. Part B of the Medicare Program (“Part B”) authorizes payment for “medical and other health services” including certain out-patient prescription drugs. 42 U.S.C. § 1395k. This case concerns Part B because it involves the out-patient administration of a prescription cancer-treatment drug. Physicians who provide services under Part B (“providers”) may submit claims to Medicare for reimbursement for the costs of purchasing and administering out-patient prescription drugs found

to be “reasonable and necessary for the diagnosis and treatment of illness[.]” 42 U.S.C. § 1395y(a). B. The Medicare Payment System and Appeals Process The Part B reimbursement system is administered by CMS in conjunction with private contractors known as Medicare Administrative Contractors (“MACs”). See 42 U.S.C. § 1395kk–1. MACs typically authorize payment of claims immediately upon receipt of the claims, so long as such claims do not contain obvious irregularities. Later, post-payment audits may be conducted either by MACs or by independent auditors. See Medicare Program Integrity Manual, CMS Pub. No. 100–08, Ch. 3, § 3.2.2. If billing irregularities are discovered in a post-payment audit,

overpayments are assessed and recouped from the provider. See 42 an overpayment assessment is entitled to five levels of administrative review: (1) a redetermination by a MAC employee not involved in the initial overpayment determination, see id. §§ 405.940-405.958; (2) a reconsideration by a Qualified Independent Contractor (“QIC”), see id. §§ 405.960, 405.976(b); (3) a hearing before an Administrative Law Judge (“ALJ”), see id. §§ 405.1000, 405.1002(a); (4) de novo review by the Medicare Appeals Council (the “Council”),2 either at the request of the provider, by referral from a MAC, or upon the Council’s own motion, see id. §§ 405.1100, 405.1102(a), 405.1110; and (5) judicial review in federal court, see 42 U.S.C. § 405(g). C. Factual and Procedural Background

Plaintiff, Dr. Ruth E. Kantor (“Dr. Kantor”), is a medical doctor practicing in oncology and internal medicine in Baltimore, Maryland. Between February 2010 and August 2012, Plaintiff purchased and administered seventeen doses of Avastin, an injectable cancer treatment drug, to her terminally ill cancer patient, Paulette D. Witherspoon. Dr. Kantor then submitted claims for reimbursement for such costs to Medicare, which totaled approximately fifty thousand dollars. Initially, the claims were approved and Dr. Kantor’s expenses were reimbursed. It was

2 The Council’s decision becomes the Secretary’s decision and is the final agency decision for purposes of judicial review. See 42 C.F.R. § 405.1136(d). Dr. Kantor was not entitled to reimbursement for the funds that she had expended on Ms. Witherspoon’s behalf. Disagreeing with this decision, Dr. Kantor initiated the five-level administrative appeals process, culminating in her filing of the instant complaint in this court requesting judicial review of the Secretary’s decision. (ECF No. 1). While the parties have not formally moved for summary judgment, the Secretary produced and filed the administrative record in this case on November 4, 2020. (See ECF Nos. 11-1 – 11- 3). Because, as detailed below, the court may only consider the administrative record in making its determination in this case,

see Camp v. Pitts, 411 U.S. 138, 142 (1973), the case is ripe for disposition and the court now rules on the basis of the administrative record alone. The arguments advanced by the parties in the context of the motion to dismiss for failure to exhaust administrative remedies in reality address the ultimate question, whether the agency’s determination was arbitrary and capricious. II. Judicial Review of the Secretary’s Decision

The Medicare Act provides for judicial review of final decisions by the Secretary of Health and Human Services regarding benefits paid under Medicare Part B. 42 U.S.C. §§ 1395ff(a),(b). Review is to be based solely on the administrative record. 42 U.S.C. § 405(g) (incorporated by reference in 42 U.S.C. § 1395ff(b)(2)(a)). Review of the Secretary’s decision is governed, moreover, by the Administrative Procedure Act, 5 U.S.C. §§ 701–706, which provides that the Agency’s be “arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law . . . or unsupported by substantial evidence.” 5 U.S.C. § 706(2)(A),(E); Natural Resources Defense Council v. U.S. Environmental Protection Agency, 16 F.3d 1395, 1400 (4th Cir. 1993).

MacKenzie Med. Supply, Inc. v. Leavitt, 419 F. Supp. 2d 766, 770 (D.Md. 2006), aff’d, 506 F.3d 341 (4th Cir. 2007). “Because the facts are restricted to those in the administrative record, the court here is primarily concerned with issues of law.” Id. “[I]t is the [c]ourt’s role to ‘determine whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did.’” Abington Mem’l Hosp. v.

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