Talamo v. Fresenius Medical Care Management, AG

CourtDistrict Court, E.D. Louisiana
DecidedJuly 3, 2019
Docket2:17-cv-03509
StatusUnknown

This text of Talamo v. Fresenius Medical Care Management, AG (Talamo v. Fresenius Medical Care Management, AG) is published on Counsel Stack Legal Research, covering District Court, E.D. Louisiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Talamo v. Fresenius Medical Care Management, AG, (E.D. La. 2019).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA

UNITED STATES OF AMERICA ex CIVIL ACTION rel. CHERI TALAMO NO. 17-3509 VERSUS SECTION M (2) FRESENIUS MEDICAL CARE HOLDINGS, INC., et al. ORDER & REASONS Before the Court is a motion for summary judgment filed by defendants Fresenius Medical Care Holdings, Inc., Spectra Laboratories, Inc., Bio-Medical Applications of Maryland, Inc., Bio- Medical Applications of Louisiana LLC, Fresenius Medical Care Louisiana Dialysis Group LLC, Renal Care Group, Inc., Bio-Medical Applications of Louisiana, Inc. (“Corporate Defendants” or “Fresenius”), and Melissa Lapworth, Heather Clark, and Nancy Landrieu (“Individual Defendants”) (collectively, “Defendants”),1 to which relator Cheri Talamo (“Talamo”) responds in opposition,2 and in further support of which Defendants reply.3 Having considered the parties’ memoranda and the applicable law, the Court issues this Order & Reasons. I. BACKGROUND This qui tam relator action arises out of Talamo’s employment as a registered nurse to provide self-care home peritoneal dialysis, a type of renal dialysis that treats end stage renal disease covered by Medicare and other government healthcare programs under 42 U.S.C. § 1395rr(b)(14)(B).4 Renal dialysis is an artificial process that replaces a failing kidney’s function, including extracting waste from blood, balancing body fluids, and forming urine. Generally, renal

1 R. Doc. 84. 2 R. Doc. 93. 3 R. Doc. 98. 4 R. Doc. 33 at 6-7, 9, 12. dialysis is adequate if it achieves nearly the same level of function as a natural kidney. The measurement of dialysis adequacy is represented as a value of “Kt/V.”5 Low levels of the Kt/V measurement are dangerous to a patient’s health. Congress enacted the end stage renal disease program in 42 U.S.C. § 1395rr to provide Medicare coverage for renal dialysis services. Subsection (h) creates financial incentives for such

providers to deliver quality services. The Secretary of the Department of Health and Human Services (“HHS”) monitors the quality of renal dialysis services of each provider to determine a total performance score. If a provider does not meet or exceed a set score, its Medicare payments may be reduced by up to 2.0%. Further, HHS established a standard of 1.70 Kt/V as the level for adequate renal dialysis. In order to receive Medicare reimbursement, a provider must submit a claim reporting its patients’ Kt/V levels.6 Talamo alleges that her employers, Fresenius Medical Care Holdings, Inc., and its subsidiaries (Corporate Defendants for purposes of this motion),7 offered peritoneal dialysis in a patient’s home, which was administered by a nurse, such as Talamo, trained to use the dialysis

equipment properly. A machine inserts a dialysate solution into a port surgically implanted in a patient’s body. Waste products produced from the dialysis process called peritoneal dialysate then

5 The National Institute of Diabetes and Digestive and Kidney Diseases explains the Kt/V measurement this way: Kt/V is another way of measuring dialysis adequacy. In this measurement,  K stands for the dialyzer clearance, the rate at which blood passes through the dialyzer, expressed in milliliters per minute (mL/min)  t stands for time  Kt, the top part of the fraction, is clearance multiplied by time, representing the volume of fluid completely cleared of urea during a single treatment  V, the bottom part of the fraction, is the volume of water a patient’s body contains Hemodialysis Dose & Adequacy, NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES, https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis/dose-adequacy (last visited July 3, 2019). 6 See R. Doc. 33 at 7-8. 7 R. Doc. 56-1 at 5. collect in bags. The machine monitors the volume of peritoneal dialysate expelled and adjusts the volume of dialysate solution allowed into the body through an “IQ drive,” a thumb drive which controls the number and volume of “fills” each night the machine runs. Patients purchase the dialysate solution from Corporate Defendants, which are paid by reimbursement from Medicare and other governmental healthcare agencies.8

Peritoneal-dialysis patients periodically come into the Corporate Defendants’ facility in Metairie, Louisiana, to receive a check-up. Every three months, a patient provides nurses, such as Talamo, with urine collected in the past 24 hours and the previous night’s bags of peritoneal dialysate. On some occasions, nurses use scales and rulers to take several measurements, including the patient’s weight, height, urine volume, and bag weight. On others, nurses use data recorded on a patient’s IQ drive to report such measurements.9 They write down the results on what Talamo calls “adequacy checklists” and enter them in the Corporate Defendants’ computer system, which stores a patient’s chart and calculates the Kt/V adequacy measurement.10 The Corporate Defendants then submit this information to governmental health agencies and insurance companies

to receive reimbursement. This information is also used by the patients’ physicians to make decisions about patient care, such as adjusting the volume of solution or removing a patient from home dialysis. Talamo alleges that the Individual Defendants were employees of Corporate Defendants and were Talamo’s supervisors. Melissa Lapworth, who oversaw a group of nurses that provided at-home dialysis service and also performed these services herself, was Talamo’s immediate

8 R. Doc. 33 at 9-10. 9 R. Docs. 84-3 at 3-4, 11 & 84-43 at 3-4, 11. 10 R. Doc. 93-1 at 3. supervisor. Lapworth’s immediate supervisor, in turn, was Heather Clark, and Clark’s supervisor was Nancy Landrieu.11 Talamo alleges that she witnessed her supervisor Lapworth knowingly entering false information into the computer system to maximize the payments received from Medicare. Talamo lists eleven incidents of allegedly fraudulent activity, including, for example, several occasions

where Lapworth adjusted patients’ time and volume settings on the computer system inconsistent with their doctors’ orders or IQ drive output, causing patients to use and order additional and medically unnecessary bags of dialysate solution. On some occasions, patients died shortly after the alleged tampering. On others, Talamo alleges that Lapworth revised the levels or cause of death that Talamo had recorded, effectively concealing poor dialysis service. Talamo also claims that the Corporate Defendants gave the Individual Defendants and other nurses bonuses to meet or exceed the 1.70 Kt/V adequacy threshold, regardless of the patient’s actual data and condition, so as to inflate their performance score for purposes of Medicare reimbursement.12 Such conduct, Talamo asserts, amounted to a conspiracy among Defendants to defraud Medicare and other

governmental healthcare agencies to pay for greater amounts of dialysate solution than was medically necessary and that would otherwise not be covered due to Corporate Defendants’ poor performance score.13 Talamo claims that she reported the fraudulent activity to the Individual Defendants but was continually rebuffed by them.14 As a result, Talamo says Defendants retaliated against her. In January 2017, Individual Defendants called several meetings with Talamo and other employees,

11 R. Doc. 33 at 6, 11-12. The Defendants say that Talamo and the Individual Defendants are all employees of defendant Bio-Medical Applications of Louisiana, LLC d/b/a Fresenius Medical Care Crescent City Home Program. R. Doc. 56-1 at 2-3. 12 R. Doc. 33 at 12-17. 13 See id. at 12-13. 14 Id. at 13, 18. during which Talamo was accused of being unhelpful and uncooperative.

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Talamo v. Fresenius Medical Care Management, AG, Counsel Stack Legal Research, https://law.counselstack.com/opinion/talamo-v-fresenius-medical-care-management-ag-laed-2019.