Edgar A. Gamboa, M.D., Medical Corp. v. Becerra

District Court, N.D. California·Decided September 29, 2023·No. 5:22-cv-02865·Unknown

Opinion

EDGAR A. GAMBOA, M.D., MEDICAL Case No. 5:22-cv-02865-EJD CORP., ORDER ON CROSS MOTIONS FOR Plaintiff, SUMMARY JUDGMENT v. Re: ECF Nos. 22, 25 XAVIER BECERRA, Defendant.

Plaintiff Dr. Edgar Gamboa seeks judicial review of the Medicare Appeals Council (“Council”) decision finding that he had improperly billed ClariVein procedures and that he was not “without fault” for the overpayments. Defendant Health and Human Services Secretary Xavier Becerra has filed excerpts of the administrative record. ECF No. 18 (“A.R.”). Both parties have moved for summary judgment in their favor. ECF Nos. 22 (“Pl. MSJ”), 25 (“Opp.”). Based on the following, the Court GRANTS IN PART and DENIES IN PART the parties’ cross motions. The Council’s decision is AFFIRMED IN PART, VACATED IN PART, and shall be REMANDED for further administrative proceedings. A. Medicare and Health Care Providers Medicare is a federal health insurance program that covers aged and disabled individuals. See 42 U.S.C. § 1395, et seq. The Centers for Medicare and Medicaid Services (“CMS”) is the federal agency that administers the program on behalf of the Defendant Secretary of Health and Human Services. 42 U.S.C. § 1395hh(a)(1). This case involves Part B of the Medicare program, which authorizes payments to health care providers for outpatient care, services, and durable medical equipment. Id. §§ 1395j, 1395k. Medicare service providers like Dr. Gamboa submit claims for reimbursement of covered services they provided, and Medicare Administrative Contractors (“MACs”) make initial determinations as to the claims’ coverage and amounts. Id. § 1395ff(a); 42 C.F.R. § 405.920. MACs generally will reimburse claims immediately unless they contain glaring irregularities, and a Zone Program Integrity Contractor (“ZPIC”) may subsequently audit the payments to determine overpayment or underpayment. 42 U.S.C. § 1395ddd(h). If there is an overpayment, the MAC can make an adjustment and seek reimbursement from the health care provider. Id. § 1395gg. When health care providers submit claims for reimbursement, they must provide a numeric code for the service or procedure as listed in the Current Procedural Terminology (“CPT”), a coding system maintained by the American Medical Association to identify and describe medical services and procedures. Based on the code provided, CMS will then pay for the covered services pursuant to the Medicare Physician Fee Schedule, which is updated annually based on the relative value units of that service or procedure. Pl. MSJ 6 n.2; Opp. 3–4. “To promote consistency in initial determinations,” MACs can issue a local coverage determination (“LCD”), which “specifies whether or under what conditions that contractor will approve reimbursement for some set of items or services.” Agendia, Inc. v. Becerra, 4 F.4th 896, 897 (9th Cir. 2021), cert. denied, 211 L. Ed. 2d 605 (Jan. 24, 2022); see also 42 U.S.C. § 1395kk01(a)(1). MACs can also issue local coverage articles (“LCAs”) that address specific coverage and billing issues. Opp. 6. B. ClariVein and Noridian’s Local Coverage Publications ClariVein is a relatively new device and procedure for treating varicose veins. Compl. ¶ 23. The procedure involves a physician inserting a catheter into the affected vein that both abrades the vein’s interior lining and delivers a medical solution to coat the inside of the vein. Id. ¶ 21. ClariVein is purportedly cheaper, faster, and safer than the traditional treatment for varicose veins, which involves vein stripping and ligation under anesthesia in a hospital. Id. ¶ 22. Although there was not a specific CPT code for ClariVein during the relevant time period, the most relevant existing CPT codes at the time were: (1) 36299 for “unlisted procedure, vascular injection”; (2) 37241 for “vascular embolization or occlusion,” A.R. 11; and (3) 37799 for “unlisted procedure, vascular surgery,” A.R. 3649. During the relevant time period, the MAC in this case—Noridian Healthcare Solutions, LLC (“Noridian”)—had not issued any LCD that directly addressed which CPT code physicians should use for the ClariVein procedure. Pl.’ Separate Statement and Responsive Separate Statement Supp. Reply (“Separate Statement”), Fact 17 (undisputed), ECF No. 26-1, at 9. However, Noridian had issued some LCAs that did specifically reference ClariVein, as well as an LCD that provided general guidance on treating varicose veins, as follows: • LCD L33497, “Treatment of Varicose Veins of the Lower Extremities,” provided a list of codes “typically used to report” treatment of varicose veins. A.R. 3648–49. This list included CPT code 37799 for “vascular surgery” but did not include either 36299 or 37241. This LCD was effective from Sept. 16, 2013 through Sept. 30, 2015, before being replaced by L34209. A.R. 3682–83, 3731. • LCA A53145,1 “Sclerosing of Varicose Veins,” provided that “CPT 37241 must not be used to bill for the treatment of varicose veins with [ClariVein]” and “[w]hen using the ClariVein device in the treatment of varicose veins[,] Noridian recommends billing with CPT code 36299.” See Opp. 6 n.7 (emphasis added) (citing Medicare Coverage Database Archive, A53145, available at https://localcoverage.cms.gov/mcd_archive/view/article.aspx?articleInfo=53145:4&ke yword=A53145). This LCA was revised on April 11, 2014, specifically to “include billing instructions for the use of ClariVein.” Id.

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