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Bailey v. Mutual of Omaha Insurance Co.

February 8, 2008


The opinion of the court was delivered by: Royce C. Lamberth, United States District Judge,


This matter comes before the Court on defendants' motion [18] to dismiss and plaintiff Louise Bailey's motion [23] for summary judgment. Specifically, defendants argue that the amended complaint [8] should be dismissed pursuant to Federal Rule of Civil Procedure 12(b)(1) because the Court lacks jurisdiction to adjudicate plaintiff's claims and pursuant to Rule 12(b)(6) because plaintiff has failed to state a claim upon which relief can be granted. Plaintiff, in contrast, contends that she is entitled to judgment as a matter of law. Upon consideration of the motions, the opposition and reply briefs, the entire record herein, and applicable law, the Court finds that defendants' motion to dismiss will be granted. Plaintiff's motion for summary judgment will be denied.


A. Parties and Preliminary Background

Plaintiff Louise Bailey brings this proposed class action on behalf of herself and similarly situated Medicare Part B beneficiaries residing in skilled nursing facilities ("SNFs") against Mutual of Omaha Insurance Company ("Mutual"),Secretary Michael O. Leavitt of the Department of Health and Human Services ("HHS"), and Acting Administrator Leslie V. Norwalk of the Centers for Medicare and Medicaid Services ("CMS"). Plaintiff is a 72 year-old diabetic SNF resident whose physician has stated that she requires blood glucose testing four times a day. (See Am. Compl. ¶ 18.) Defendant Mutual is a Medicare "fiscal intermediary" responsible for processing Medicare claims of plaintiff Bailey and the proposed class members. (See id. ¶ 1.) HHS and CMS are responsible for the administration of the Medicare program. (See id. ¶ 1.) Mutual denied claims for Ms. Bailey's blood glucose tests performed in October 2005. (See Attach. 1 to Routt Decl. at 53--55.) In count 1 of the amended complaint, Ms. Bailey asserts that continuing enforcement of Mutual's retired Local Coverage Determination ("LCD")-which set forth a standard for coverage and payment of blood glucose test claims for Part B beneficiaries-is the basis for the denial of her claims and that this constitutes a violation of the Medicare Act and regulations. (See Am. Compl. ¶ 108--113; LCD, Ex. C to Mot. to Dismiss.) In count 2, plaintiff alleges a due process violation on behalf of herself and putative class members grounded on inadequate notice to beneficiaries of (1) the invalidity of the retired LCD and (2) the policy basis for Mutual's claim denials. (See Am. Compl. ¶ 114--20.)

B. Events Prior to Denial of Ms. Bailey's Blood Glucose Test Claims

Ms. Bailey's SNF submitted a claim for payment on November 4, 2005 for tests performed the previous month. On December 7, 2005, Mutual requested additional information to determine whether the testing was "reasonable and necessary" such as: (a) physician orders, (b) documentation of necessity for each test including nurse's notes and physician progress notes, (c) results, (d) documentation of doctor notification of each test noting use of the test results to modify treatment, (e) detailed itemization of charges billed, and (f) medical history and a physical supporting diagnosis of diabetes. (See Attach. 1 to Routt Decl. at 104, 106.) The SNF responded with documentation on December 12, 2005. (See id. at 105--22.) Its response indicated that plaintiff was admitted to the SNF in July 2004 with a physician order for blood glucose testing two times per week. (See id. at 111--16.) Nurse notes were included for October 20, 2005 thru November 29, 2005, but did not show whether the physician was notified of the results. (See id. at 118.)However, the nurse did note that the doctor had ordered-by phone-an additional daily test. (See id. at 117.) Defendants indicate that the nurse notes demonstrate a clear absence of adequate documentation and an absence of doctor involvement. Following the SNF's response, Mutual denied the claim stating that "the information provided does not support the need for this service or item." (See id. at 53, 55.) Defendants contend that the denial is based on medical necessity and is in no manner based on the LCD that plaintiff challenges here.

C. Medicare Statutory Background

A National Coverage Determination ("NCD") is a determination by the HHS Secretary with respect to whether or not a particular item or service is covered nationally by Medicare. See 42 U.S.C. § 1395ff(f)(1)(B). All Medicare contractors, including carriers and fiscal intermediaries, are legally bound by NCDs. See 42 C.F.R. § 405.1060(a)(4). In contrast, LCDs are determinations by fiscal intermediaries-such as Mutual-or carriers respecting whether a particular item or service is covered on an intermediary or carrier-wide basis. 42 U.S.C. §1395ff(f)(2)(B). The HHS Secretary is instructed to evaluate new LCDs to determine whether they should be adopted nationally and to what extent consistency among LCDs can be achieved.

42 U.S.C. § 1395y(l)(5)(A). Mutual issued a revised version of the blood glucose testing LCD at issue here with effective date September 21, 2005, which detailed Mutual's coverage policy.*fn1 (See LCD, Ex. C to Mot. to Dismiss.) Under the Medicare system, a challenge to an LCD or NCD is distinct from the general Medicare claims appeal process set forth in 42 U.S.C. § 405(g). Review of an LCD permits an aggrieved party to examine an entire policy or provision rather than specific claim denials.*fn2 When a beneficiary is confronted with a denied claim that he or she wishes to challenge, the beneficiary has the option of pursuing review through the claims appeal process, seeking review of an LCD or NCD, or both. See Review of National Coverage Determinations and Local Coverage Determinations, 68 Fed. Reg. 63692, 63693--94 (Nov. 7, 2003) (comparing the claims appeal process and the NCD and LCD review processes). When the LCD review process was created, the existing claims appeal procedures remained unaltered. Thus, beneficiaries whose claims have been denied have access to de novo review by an independent administrative law judge ("ALJ") and ultimately to federal district court review. Id at 63693; see 42 U.S.C. §§ 405(g), 1395ff(b) (setting out these procedures).

D. Plaintiff's Administrative Challenge

Ms. Bailey instituted her challenge as a review of Mutual's blood glucose testing LCD pursuant to the procedures outlined at 42 U.S.C. § 1395ff(f)(2) and claimed that the LCD was contrary to the relevant NCD and to medical best practices. On April 19, 2006, the ALJ certified that plaintiff met the requisites of an LCD challenge. (Admin. R. at 22--28); see 42 C.F.R. § 426.410(b)--(d). In that proceeding, Ms. Bailey moved for summary judgment alleging that the LCD was incomplete and inadequate under the reasonableness standard set forth in the regulatory scheme. (See Admin. R. at 649--50); see also 42 C.F.R. §§ 426.110; 426.425(a) (indicating that a challenged LCD is reviewed for reasonableness). Shortly before Mutual's response was due, Mutual retired its LCD. (See Admin. R. at 736.) Consequently, Administrative Law Judge Sickendick was deprived of jurisdiction because retired LCDs are not subject to review. (Admin. R. at 1--2); see 42 C.F.R. § 426.325(a), (b)(2). The ALJ was required to dismiss the complaint and inform plaintiff that she would receive individual claim review without application of the retired LCD. 42 C.F.R. § 426.420(e)(1); see 42 C.F.R. §§ 426.420(a); 426.460(b) (indicating that retiring an LCD has the same effect as a decision that an LCD is invalid under the reasonableness standard, which entitles the aggrieved party to a Medicare contractor's individual claim review without reliance on the retired LCD). Because aggrieved parties are granted individual claim review-the same review that would have been available had the adjudicator not been bound by the now irrelevant LCD-HHS regulations provide that the LCD review process concludes upon the relevant LCD's retirement. See Review of National Coverage Determinations and Local Coverage Determinations, 68 Fed. Reg. 63692, 63698 (Nov. 7, 2003). Moreover, CMS policy explicitly states that when it retires an LCD, it will not apply those policies for future services and will reprocess an aggrieved party's affected claims without reference to the retired policy. See id. Accordingly, in a letter dated December 19, 2006, Mutual indicated that it had performed an individual claim review without the application of the blood glucose testing LCD and that it had affirmed denial of plaintiff's claim. (See Ex. 17 to Am. Compl.)

E. Plaintiff's Action Before this Court

On December 15, 2006, plaintiff filed suit in this Court asserting a claim of improper reliance on the retired LCD and a due process violation arising from alleged inadequate notice to plaintiff and putative class members. In her first claim, Ms. Bailey argues that following retirement of the LCD, Mutual continued to apply the now invalid LCD. Plaintiff alleges that despite CMS's NCD that supports frequent testing, CMS has engaged in a plan to systematically deny coverage for blood glucose testing of Part B beneficiaries in SNFs. (See Am. Compl. ¶¶ 14, 71, 113.); Coverage and Administrative Policies for Clinical Diagnostic Laboratory Services, 66 Fed. Reg. 58788, 58846 (Nov. 23, 2001) (setting forth blood glucose NCD). Under this alleged scheme, upon the LCD's retirement, CMS adopted regulations consisting of a "trumped-up" medical necessity requirement and a provision that a physician's "standing order" of a series of blood glucose tests would not be payable. (See Am. Compl. ¶ 11); 42 C.F.R. § 424.24(f) (enacted Dec. 1, 2006). Under plaintiff's ...

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