Medicomp, Inc. v. Sec'y
| Decision Date | 03 March 2016 |
| Docket Number | Case No: 6:14-cv-1848-Orl-28DAB |
| Parties | MEDICOMP, INC., Plaintiff, v. SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant. |
| Court | U.S. District Court — Middle District of Florida |
In this appeal pursuant to 42 U.S.C. § 1395ff, Plaintiff Medicomp, Inc. challenges the final decision of the Secretary of the United States Department of Health and Human Services ("the Secretary") denying reimbursement on sixteen claims for payment under Medicare.1 As set forth below, the decision of the Secretary is affirmed.
The Medicare Act, which is Title XVIII of the Social Security Act, "establishes a federally subsidized health insurance program to be administered by the Secretary." Heckler v. Ringer, 466 U.S. 602, 605 (1984). The Secretary administers the Medicare program through the Center for Medicare and Medicaid Services ("CMS"). CMS, in turn, contracts with private entities called Medicare Administrative Contractors ("Contractors")to assist it with administration of the program. Healthcare providers and suppliers submit their claims for reimbursement under Medicare to the Contractor in their region. The Contractor then determines whether the services provided are covered by Medicare; if so, the Contractor reimburses the provider or supplier.
Plaintiff is a supplier of remote cardiac monitoring services.2 Remote cardiac monitoring is a methodology for ascertaining whether or not a patient's symptoms correlate with cardiac arrhythmia—a rapid or slow heart rate—and it enables cardiologists to determine what happens after a patient leaves the examination room. When a physician orders Plaintiff's monitoring services for a patient, Plaintiff receives a prescription from the physician either through an online enrollment or by facsimile indicating that the patient is being hooked up to one of Plaintiff's cardiac event monitors at the physician's office. Physicians and patients throughout the country order and receive Plaintiff's services, but Plaintiff is located in Florida.
With regard to each of the claims for payment at issue in this case, a cardiac event monitor designed by Plaintiff called the "Cardio-PAL3 SAVI" was ordered by a physician and worn by a patient for up to thirty days. The monitor, which is a type of device known as a "memory loop recorder" that is the size of a cellular telephone, attaches to the patient's waist, and three electrodes are attached to the patient's chest. The device automatically records any heartrate that is "clinically significant"—slow, fast, or irregular. Additionally, ifthe patient notices symptoms, the patient can trigger the device to record the heartrate at a particular moment. The device informs the patient when it is time to call the cardiac monitoring center. The patient then contacts a technician at Plaintiff's monitoring center in Melbourne, Florida, and places the device next to the mouthpiece of a landline telephone. The device emits a series of tones that are decoded back into electrocardiogram (EKG) wave form at the monitoring center, and Plaintiff's technicians examine the EKG. Plaintiff then produces a report and forwards it to the ordering physician.
Plaintiff participates in the Medicare program as an Independent Diagnostic Testing Facility ("IDTF").4 When Plaintiff provides cardiac monitoring services to a Medicare beneficiary, Plaintiff submits a Medicare claim for payment for use of the event monitor for up to thirty days and preparation of the report that it provides to the physician. At all times relevant to this case, the Contractor for Florida—to whom Plaintiff was required to submit its claims for payment under Medicare—was First Coast Service Options, Inc. ("First Coast"). In 2011, First Coast denied twenty-seven of Plaintiff's claims with dates of service in 2009 and 2010, concluding that the documentation submitted by Plaintiff in support of those claims did not establish that the cardiac monitoring services that Plaintiff provided to those twenty-seven Medicare beneficiaries were medically necessary as required for Medicare payment.
After First Coast again denied those twenty-seven claims upon a request by Plaintiff for redetermination, Plaintiff appealed the denials through three levels of administrative review, including review by an administrative law judge ("ALJ") and by the MedicareAppeals Council ("the Council").5 After the decision of the Council, sixteen of Plaintiff's claims remain denied.6 Plaintiff now seeks judicial review of the Council's ruling on those sixteen claims, which is regarded as the final decision of the Secretary.
This appeal is brought pursuant to 42 U.S.C. § 1395ff, which provides for "judicial review of the Secretary's final decision . . . as is provided in section 405(g) of [Title 42]," with the proviso that "any reference to the 'Commissioner of Social Security' or the 'Social Security Administration' in subsection (g) . . . of section 405 . . . shall be considered a reference to the 'Secretary' or the 'Department of Health and Human Services,' respectively." 42 U.S.C. § 1395ff(b)(1)(A). In other words, once the Secretary renders a final decision on a Medicare claim, judicial review is available "in the same manner as is provided in 42 U.S.C. § 405(g) for old age and disability claims arising under Title II of the Social Security Act." Ringer, 466 U.S. at 605 (footnote omitted). "Pursuant to 42 U.S.C. § 405(g), 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, Inc. v. Sec'y, Dep't of Health & Human Servs., 468 F.3d 1347, 1350 n.3 (11th Cir.2006) (alterations in original) (quoting Wilson v. Barnhart, 284 F.3d 1219, 1221 (11th Cir. 2002)).7
In denying payment for the sixteen claims at issue, the Secretary determined that the documentation submitted by Plaintiff did not establish that the services provided to the sixteen Medicare beneficiaries were "reasonable and necessary for the diagnosis and treatment of illness or injury" as required for Medicare payment. The Secretary applied documentation requirements that are contained in a Local Coverage Determination ("LCD")issued by First Coast. Plaintiff contends that the Secretary erred in relying on the LCD, and Plaintiff maintains that it submitted all the documentation that it was required under Medicare to submit to establish medical necessity. As set forth below, the Secretary applied the correct legal standards and the Secretary's findings are supported by substantial evidence. Accordingly, the Secretary's decision is due to be affirmed under 42 U.S.C. § 1395ff(b)(1)(A), which incorporates by reference 42 U.S.C. § 405(g).8
Under Medicare, "no payment may be made . . . for any expenses incurred for items or services . . . [that] are not reasonable and necessary for the diagnosis and treatment of illness or injury." 42 U.S.C. § 1395y(a)(1)(A). Moreover, "[n]o payment shall be made to any provider of services . . . unless there has been furnished such information as may be necessary in order to determine the amounts due such provider." Id. § 1395l(e); see also 42 C.F.R. § 424.5(a)(6) ().
"The Medicare Act authorizes the Secretary to determine what claims are covered by the Act 'in accordance with the regulations prescribed by him.'" Ringer, 466 U.S. at 605 (quoting 42 U.S.C. § 1395ff(a)). In addition to the regulations the Secretary prescribes, the Secretary provides coverage instruction through policy manuals9 and other guidance. The Secretary may, through CMS, issue a National Coverage Determination ("NCD")—"adetermination by the Secretary with respect to whether or not a particular item or service is covered nationally." 42 U.S.C. § 1395ff(1)(B). Additionally, First Coast, like other Contractors, is permitted to issue LCDs—"determination[s] by a [Contractor] . . . respecting whether or not a particular item or service is covered on a [Contractor]-wide basis . . ., in accordance with [42 U.S.C. §] 1395y(a)(1)(A)." Id. § 1395ff(f)(2)(B); accord Medicare Program Integrity Manual § 13.1.3 ().
NCDs are binding on all Contractors, ALJs, and the Council. 42 C.F.R. § 405.1060(a)(4). And, in deciding claim appeals, neither an ALJ nor the Council may "disregard, set aside, or otherwise review an NCD," id. § 405.1060(b)(1) & (c)(1), though they "may review the facts of a particular case to determine whether an NCD applies to a specific claim for benefits and, if so, whether the NCD was applied correctly to the claim," id. § 405.1060(b)(2) & (c)(2). On the other hand, "ALJs and the [Council] are not bound by LCDs . . . but will give substantial deference to [them] if they are applicable to a particular case." Id. § 405.1062(a).10 "An ALJ or [the Council] may not set aside or review the validity of an . . . LCD for purposes of a claim appeal." Id. § 405.1062(c).
Plaintiff's primary argument is that the Secretary's decision ignored an NCD issued by CMS—NCD 20.15—and instead erroneously relied on an LCD issued by First Coast—LCD L29253. Plaintiff contends that NCD 20.15 required Medicare reimbursement for the remote cardiac monitoring services at issue and that LCD L29253 is impermissibly more restrictive than, and in conflict with, NCD 20.15. The Secretary, on the other hand, maintains that LCD L29253 is consistent with NCD 20.15 and was properly applied...
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