In re LCD Complaint: Noncovered Services (L33777), DAB CR5618 (2020)

DECISION DISMISSING COMPLAINT

The aggrieved party (AP) challenged a provision in Local Coverage Determination (LCD) ID No. L33777 that, by the time of the filing of the LCD complaint, had been removed from L33777, and placed in a local coverage article.  Local Coverage Article No. A57743, which also contained the challenged provision, was recently revised to remove that provision.  Therefore, I dismiss the AP's complaint because the AP challenged a provision that has been removed from L33777 and A57743.

I.  Background

On March 6, 2020, the AP filed a complaint seeking administrative law judge (ALJ) review of L33777, an LCD published by Medicare contractor First Coast Service Options, Inc. (First Coast).  The AP indicated that he needed a continuous glucose monitor (CGM) with an implantable sensor.  As required by 42 C.F.R. § 426.400(c)(4)(iii), the AP specified the provision of L33777 that adversely affected the AP's ability to obtain Medicare coverage for the CGM.  The AP stated that the inclusion of Current Procedural Terminology (CPT) codes 0446T through 0448T in the "CPT/HCPCS Codes" section of L33777 under the subtitle "Procedures for Part A and Part B" meant that those codes were not covered by Medicare.

On March 16, 2020, I acknowledged receipt of the AP's complaint and issued a prehearing order establishing a schedule for the submission of the LCD record as well as

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the parties' arguments as to whether the LCD record was complete and adequate to support the validity of L33777 under the reasonableness standard.  42 U.S.C. § 1395ff(f)(2)(A)(i)(I); 42 C.F.R. §§ 426.403, 426.405(b), 426.425, 426.431.

On April 14, 2020, First Coast filed the LCD record for L33777, which included a copy of the version of L33777 that became effective on November 27, 2019 (CMS Ex. 1).  On May 4, 2020, the AP filed his argument (AP Statement) as to why the challenged provision was not reasonable and 89 exhibits.  The AP also filed a copy of the version of L33777 that became effective on November 27, 2019 (A. Ex. 1).

On May 8, 2020, First Coast moved for dismissal of the AP's complaint against L33777 because, effective May 7, 2020, First Coast removed CPT codes 0446T through 0448T from Local Coverage Article A57743, an article associated with L33777.  First Coast filed a copy of the revised A57743 (CMS Ex. 6).

II.  Analysis

An LCD is "a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered [under the Medicare program] on an intermediary- or carrier-wide basis . . . ."  42 U.S.C. § 1395ff(f)(2)(B).  At least 45 days before an LCD becomes effective, each Medicare administrative contractor must make the following available on its internet website and on the Medicare website:  where and when the proposed LCD was made public; hyperlinks to the proposed determination and a response to comments submitted to the contractor concerning the proposed determination; the entire LCD; a summary of the evidence that was considered by the contractor and a list of the sources of such evidence; and an explanation of the rationale that supports the LCD.  42 U.S.C. § 1395y(l)(5)(D).  The Secretary of the Department of Health and Human Services coordinates the LCDs issued by the various fiscal intermediaries and carriers and determines when LCDs should be adopted nationally.  42 U.S.C. § 1395y(l)(5)(A)-(C).

When a fiscal intermediary or carrier issues an initial determination denying coverage of an item or service, the determination must state whether an LCD was used in making that determination.  42 U.S.C. § 1395ff(a)(4)(A)(i).  If a qualified independent contractor considers a claim on reconsideration, the LCD "shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration" but "the qualified independent contractor shall consider the local coverage determination in making such decision."  42 U.S.C. § 1395ff(c)(3)(B)(ii)(II).  If a case is further appealed to an ALJ at the Office of Medicare Hearings and Appeals or to the Medicare Appeals Council at the Departmental Appeals Board, the ALJ and the Council are not bound by the LCD, but must give the reasons for not following an LCD.  42 C.F.R. § 405.1062.  Outside of the Medicare claims appeal process, a beneficiary entitled to Medicare Parts A and/or B who is in need of Medicare coverage for items or services denied under the

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LCD may seek review of an LCD by an ALJ, who will only defer to reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law.  42 U.S.C. § 1395ff(f)(2)(A)(i)(III); see also 42 C.F.R. §§ 426.110, 426.431.  The ALJ may uphold or invalidate the challenged LCD provision.  42 C.F.R. § 426.450.  However, the ALJ must confine such a decision to "the provision(s) of the LCD raised in the [AP's] complaint."  42 C.F.R. § 426.431(a)(1).

A CMS contractor may retire or revise an LCD under review at any time before an ALJ issues a decision.  42 C.F.R. § 426.420(a)-(b).  When this happens, the CMS contractor must notify the ALJ that it has retired or revised the LCD.  42 C.F.R. § 426.420(c).  Upon receiving such notice, an ALJ must dismiss the complaint concerning the retired LCD or revised LCD (if the provision challenged in the complaint has been completely removed) so that the AP can receive individual claim review without the retired LCD or the without the provision removed from the revised LCD.  42 C.F.R. §§ 426.420(e)(1), 426.444(b)(6).  Significantly, when an LCD is retired or revised during the LCD complaint process, that retirement has the same effect as an ALJ decision finding that the challenged LCD provision is invalid.  42 C.F.R. §§ 426.420(a)-(b), 426.460(b).  For claims that have already been denied, this means that "the contractor, an M + C organization or another Medicare managed care organization must reopen the claim of the party who challenged the LCD and adjudicate the claim without using the provision(s) of the LCD that the ALJ found invalid."  42 C.F.R. § 426.460(b)(1)(i).  If a claim had not yet been submitted to a CMS contractor, then once a claim is filed, "the contractor adjudicates the claim without using the provision(s) of the LCD that the ALJ found invalid."  42 C.F.R. § 426.460(b)(1)(iii).  Further, "the claim and any subsequent claims for the service provided under the same circumstances is adjudicated without using the LCD provision(s) found invalid."  42 C.F.R. § 426.460(b)(1)(iv).

In the present case, First Coast revised L33777 as of November 27, 2019.  "[T]he LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions ('Bill Type Codes,' 'Revenue Codes,' 'CPT/HCPCS Codes' . . .) and place them into a newly created billing and coding article."  CMS Ex. 1 at 29; A. Ex. 1 at 29.  Further, as of May 7, 2020, First Coast revised A57743 so that "the Implantable Interstitial Glucose Sensor CPT codes 0446T, 0447T, and 0448T were removed from the 'CPT/HCPCS Codes/Group 1 Codes:' section of the Billing and Coding article."  CMS Ex. 6 at 30.

Based on the November 27, 2019 revision to L33777, L33777 no longer included the challenged provision (i.e., the challenged CPT codes).  As a result, I dismiss the complaint because the challenged provision is no longer in effect.  42 C.F.R. § 426.444(b)(6); see also 42 C.F.R. § 426.325(b)(3).

In the alternative, if the AP actually challenged A57743 related to CPT codes 0446T through 0448T, then I dismiss the complaint because A57743 was revised as of May 7,

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2020, to completely remove the challenged provision.  42 C.F.R. §§ 426.420(e)(1), 426.444(b)(6); see also 42 C.F.R. § 426.325(b)(3).

I note that, for the first time in his statement filed with his proposed exhibits, the AP requested that I invalidate L33777 entirely, but at a minimum, requested that I invalidate the challenged CPT codes.  AP Statement at 9.  During my review of this matter, I must "[c]onfine the LCD review to the provision(s) of the LCD raised in the [AP's] complaint."  42 C.F.R. § 426.431(a)(1).  Therefore, I have no jurisdiction to review the validity of the entire LCD.

III.  Conclusion

For the reasons explained above, I dismiss the AP's complaint.