In re LCD Complaint: Continuous Glucose Monitors, DAB CR5551 (2020)

DECISION DISMISSING LOCAL COVERAGE DETERMINATION COMPLAINT

The letter of a Medicare beneficiary (Beneficiary)1 dated November 30, 2019, was treated as a complaint challenging a Local Coverage Determination (LCD) related to continuous glucose monitors.  The complaint is dismissed as unacceptable pursuant to 42 C.F.R. § 426.410(c)(2). The Beneficiary is entitled to request further review by the Appellate Division of the Departmental Appeals Board (the Board) as explained hereafter.

I. Background

In a letter dated November 30, 2019, the Beneficiary complained that Medicare does not cover the FreeStyle Libre™ continuous glucose monitoring system.  The Beneficiary and his physician represent that the Beneficiary requires a continuous glucose monitoring system due to the Beneficiary’s inability to use glucose monitors that require a finger-stick. The case was assigned to me on January 3, 2020. I construed the letter to be a complaint challenging an unspecified LCD related to continuous glucose monitoring systems. 

I advised the Beneficiary by letter dated January 3, 2020, that I had evaluated his complaint pursuant to 42 C.F.R. § 426.410 and concluded that it was unacceptable. Therefore, I granted the Beneficiary until February 7, 2020, to file an acceptable amended

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complaint. As of the date of this decision, the Medicare beneficiary has filed no response and no amended complaint. 

II. Discussion

A. Applicable Law

Section 1862 of the Social Security Act (the Act) (42 U.S.C. § 1395y), which is applicable to both Medicare Part A and Part B, provides that no payment may be made for items or services “which . . . are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member . . . .”  The Secretary of the Department of Health and Human Services (the Secretary) has provided by regulation that any services not reasonable and necessary for one of the purposes listed in the regulations are excluded from coverage under Medicare.  42 C.F.R. § 411.15(k).  The Medicare Benefit Policy Manual, CMS pub. 100-02, ch.16, §§ 10 and 20, provides that no payment may be made for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

The Centers for Medicare and Medicaid Services (CMS) administers the Medicare program (Act §§ 1102, 1871, 1874 (42 U.S.C. §§ 1302, 1395hh, 1395kk)) and contracts with carriers and intermediaries (Medicare contractors) to act on its behalf in determining and making payments to providers and suppliers of Medicare items and services.  Act §§ 1816, 1842 (42 U.S.C. §§ 1395h, 1395u).  The Act provides for both National Coverage Determinations (NCD) and LCDs.  Act § 1869(f)(1)(B) and (2)(B) (42 U.S.C. § 1395ff(f)(1)(B) and (2)(B)).  An LCD, as defined by the Act, is “a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered” within the area covered by the contractor.  Act § 1869(f)(2)(B) (42 U.S.C. § 1395ff(f)(2)(B)); 42 C.F.R. § 400.202.  In the absence of a NCD or an LCD, individual claims determinations are made based upon an individual beneficiary’s particular factual situation.  68 Fed. Reg. at 63,693 citing Heckler v. Ringer, 466 U.S. 602, 617 (1984) (recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication); 42 C.F.R. §§ 426.420(a), (b), (e)(1), 426.460(b)(1), 426.488(b). 

An aggrieved Medicare beneficiary who has been denied coverage for an item or service based on an LCD may challenge that LCD before an administrative law judge (ALJ).  The aggrieved party initiates the review by filing a written complaint that meets the criteria specified in the governing regulations.  42 C.F.R. §§ 426.400; 426.410(b)(2).  If an ALJ determines that the complaint is unacceptable, the ALJ must provide the aggrieved party one opportunity to amend the unacceptable complaint.  42 C.F.R. § 426.410(c)(1).  If the aggrieved party fails to submit an acceptable amended complaint within a reasonable timeframe as determined by the ALJ, the ALJ must issue a decision

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dismissing the unacceptable complaint. 42 C.F.R. § 426.410(c)(2). If a complaint is determined unacceptable after one amendment, the beneficiary is precluded from filing again for six months after being informed that it is unacceptable. 42 C.F.R. § 426.410(c)(3). 

B. Findings of Fact, Conclusions of Law, and Analysis

1. The Beneficiary failed to file an amended complaint within the allotted timeframe, and dismissal is required by 42 C.F.R. § 426.410(c)(2). 

In my letter to the Beneficiary dated January 3, 2020, I advised the Beneficiary that he had provided evidence of entitlement to benefits under Medicare.  The Beneficiary also submitted a letter from his physician stating the Beneficiary needed a FreeStyle Libre™ continuous glucose monitoring system that the doctor believes is not covered by Medicare.  However, the Beneficiary failed to present any evidence that Medicare coverage for a FreeStyle Libre™ continuous glucose monitoring system would be denied based on the provisions of an LCD.  I advised the Beneficiary that he must identify or provide a copy of any LCD that would be cited by a Medicare contractor as a basis for denying a claim for Medicare payment for the continuous glucose monitoring system he needs.  42 C.F.R. § 426.400(c)(4)(i), (ii).  I also advised the Beneficiary that if he identified an LCD that would be used to deny coverage, he must explain why the challenged LCD provisions are not valid under the reasonableness standard established by the regulations.  42 C.F.R. § 426.400(c)(4)(iii), (c)(5).  Finally, I informed the Beneficiary that he failed to submit any clinical or scientific evidence in support of the complaint, much less an explanation of why that evidence shows that a challenged LCD is not reasonable.  42 C.F.R. § 426.400(c)(6).

I gave the Beneficiary reasonable time, until February 7, 2020, to amend his complaint.  I advised the Beneficiary that his amended complaint must satisfy all the requirements for an acceptable complaint specified at 42 C.F.R. § 426.400.  I advised him that if the amended complaint did not contain all the required information, I would dismiss his case.

No amended complaint has been received, and dismissal is required by 42 C.F.R. § 426.410(c)(2).  The Beneficiary in this case has identified no LCD that prevents coverage for a continuous glucose monitoring system and none has been located.

2. Appeal rights.  42 C.F.R. §§ 426.462, 426.465.

Pursuant to 42 C.F.R. § 426.465(a), an aggrieved party may request review by the Board.  Except upon a showing of good cause, a request for review by the Board must be filed within 30 days of the date of this decision (42 C.F.R. § 426.465(e)) and must comply with the requirements of 42 C.F.R. § 426.465(f).

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III. Conclusion

For the foregoing reasons, the complaint is dismissed.

1. The names of Medicare beneficiaries are not listed in published decisions to protect their privacy. 68 Fed. Reg. 63,691, 63,711 (Nov. 7, 2003).
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