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                              2021
                              In re LCD Complaint: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718), DAB CR5908 (2021)
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In re LCD Complaint: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718), DAB CR5908 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





*In re LCD Complaint:*
Positive Airway Pressure (PAP)
Devices for the Treatment of
Obstructive Sleep Apnea (L33718)
Docket No. C-21-876Decision No. CR5908July 21, 2021

        
              
    

      DECISION DISMISSING UNACCEPTABLE COMPLAINT

For the reasons stated below, I must dismiss the Complaint challenging local coverage determination (LCD) L33718.

I.  Background and Procedural History

LCDs are policies issued by Medicare fiscal intermediaries or carriers, generally known as contractors.  42 C.F.R. § 426.110 (definition of *Contractor*).  The regulations define LCD as follows:

*Local coverage determination (LCD)* means a decision by a fiscal intermediary or a carrier under Medicare Part A or Part B, as applicable, whether to cover a particular service on an intermediary-wide or carrier-wide basis in accordance with section 1862(a)(1)(A) of the [Social Security] Act.  An LCD may provide that a service is not reasonable and necessary for certain diagnoses and/or for certain diagnosis codes.

42 C.F.R. § 400.202.  LCDs may be challenged under 42 U.S.C. § 1395ff(f) and 42 C.F.R. pt. 426.  Only individuals qualifying as an “aggrieved party,” as defined below, may file a complaint challenging the validity of an LCD.  42 C.F.R. § 426.320.

**Page 2**

*Aggrieved party* means a Medicare beneficiary, or the estate of a Medicare beneficiary, who—

(1) Is entitled to benefits under Part A, enrolled under Part B, or both (including an individual enrolled in fee-for-service Medicare, in a Medicare + Choice plan, or in another Medicare managed care plan);

(2) Is in need of coverage for a service that is denied based on an applicable LCD (in the relevant jurisdiction) or an NCD, regardless of whether the service was received; and

(3) Has obtained documentation of the need by the beneficiary's treating physician

42 C.F.R. § 426.110.

After receiving a complaint, an administrative law judge must first determine if the complaint is acceptable under the requirements in 42 C.F.R. § 426.400.42 C.F.R. §§ 426.405(c)(1), 426.410(b).

C.A. (Aggrieved Party or AP) filed a Complaint with the Civil Remedies Division (CRD) on June 28, 2021, challenging LCD L33718.  CRD assigned this matter to me for adjudication.  After receiving the AP’s Complaint, I determined that the Complaint was not acceptable under the requirements in the regulations.  In a July 7, 2021 Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), I informed the AP that he had 30 days to file a valid amended complaint that contained the following:

*Timeliness information:*A complete copy of the initial denial notice that includes the date of the notice;
	*LCD-identifying information*:  [T]he specific provision(s) of the LCD adversely affecting the AP; and
	*Clinical or scientific evidence:*  Copies of clinical or scientific evidence that support the complaint and an explanation for why the AP thinks that this evidence shows that the LCD is not reasonable.In my Order, I specified the following in relation to the necessary amendments above:

Here, the AP states in his Complaint that he “purchased my own new CPAP device and supplies since DME suppliers cannot bill Medicare for them due to lack of necessary

**Page 3**

documentation.”  Although the AP included a copy of a February 8, 2021, invoice for the purchase, the AP did not include with his submission any denial notice indicating that he submitted a Medicare claim for coverage of the PAP and supplies that he purchased and that Medicare denied the claim.  Because the AP is challenging the LCD *after* receiving the service, the AP must file his LCD challenge within 120 days of the initial denial notice.  42 C.F.R. § 426.400(b).  The AP submits no documentation that he submitted a claim to Medicare and received an initial denial notice.

**Note:  The AP’s physician statement asserts that the AP’s Medicare claim was denied and asserts that, under National Coverage Determination (NCD) 240.4, the AP should have received coverage for his PAP and supplies.  If the AP has been denied coverage, the AP may appeal that denial under the Medicare claims process.  The denial notice should provide information as to how the AP may appeal.  The LCD challenge process is a separate process to challenge the validity of a provision or provision(s) in an LCD.**

The Complaint is also missing information necessary to constitute a valid complaint.  The AP argues, in part, that LCD L33718 incorrectly defines obstructive sleep apnea (OSA).  However, OSA is not a term that is defined in the LCD and the AP does not identify the specific provision(s) of the LCD adversely affecting the AP.  Although, it seems possible that the AP is challenging the initial coverage criteria I.B. related to the apnea-hypopnea index (AHI).

The Complaint is also missing clinical or scientific evidence that shows that an LCD provision is unreasonable.  The physician statement includes citation to three medical/scientific articles[; however], those articles were not submitted.

On July 16, 2021, the AP timely filed a response.  The AP stated that his physician mistakenly indicated that the AP’s Medicare claim had been denied.  The AP explained that, because he does not meet the LCD requirements for coverage, Medicare suppliers told the AP that they would not file a Medicare claim for reimbursement of the items he needed.  As a result, the AP has not had any Medicare claims denied.  However, he did

**Page 4**

purchase the items.  The AP also clarified the provision in the LCD he is challenging and provided the medical/scientific articles cited in his physician’s statement.

II.  Discussion

I am unable to conclude that the AP’s Complaint, as amended, is acceptable because it does not comply with all of the requirements in 42 C.F.R. § 426.400.  Specifically, the AP’s Complaint is not timely filed.  The relevant regulations provide:

(b) *Timeliness of a complaint.* An LCD complaint is not considered timely unless it is filed with the office designated by CMS within—

(1) 6 months of the issuance of a written statement from each aggrieved party's treating practitioner, in the case of aggrieved parties who choose to file an LCD challenge **before** receiving the service; or

(2) 120 days of the initial denial notice, in the case of aggrieved parties who choose to file an LCD challenge **after**receiving the service.

42 C.F.R. § 426.400(b) (emphasis added).  Therefore, in order for a complaint to be timely, it must either be brought before receiving the needed medical device, in which case the AP has six months to file from the issuance of a written statement from a treating practitioner, or else the complaint must be filed within 120 days of an initial Medicare claim denial after receiving the needed medical device.  There is no timeframe for filing a complaint after purchasing the device, but before a Medicare claim has been denied.  The preamble to the final rule provides the following as the history behind that provision:

Comments:  We received two comments in support of our proposed definition of an aggrieved party as a beneficiary in need of a service and who has not yet received the service that is the subject of the coverage determination.  While these commenters felt that it is correct to allow aggrieved parties to initiate the review of an LCD or NCD, they wrote that opening up the LCD/NCD review process to beneficiaries who have already received the service would result in unnecessarily complicated adjudications.  However, over half of all commenters on the rule suggested that the definition was too narrow and should be expanded.  Some commenters stated that the proposed definition was far too restrictive and

**Page 5**

suggested that we remove the requirement that the service not be received at the time the complaint is filed.  One commenter pointed out that the proposed definition would insulate certain LCDs and NCDs from ever being challenged because some LCDs/NCDs address services that are only used in emergency or urgent situations where the beneficiary would be incapable of filing a challenge prior to receiving the service.  Some commenters suggested that beneficiaries would lose their section 522 rights if they chose not to forego urgent treatment.  One commenter suggested that we revise the definition to require that the beneficiary be in need of coverage for a service.  One commenter specifically requested the establishment of an emergency appeals process.

Response:  In response to these comments, we have interpreted the statutory requirements more broadly and have expanded the definition of aggrieved party to require that the beneficiary be in need of coverage of a service.  **Therefore, the definition includes beneficiaries who have already received the service.**  We believe this change obviates the need for an emergency appeals process because a beneficiary can obtain an emergency service and then seek review without forgoing his or her rights.  **In order to define which beneficiaries have standing as aggrieved parties, we have added a requirement in § 426.400(b)(2) and § 426.500(b)(2) that aggrieved parties, who have received a service and have filed a claim, must file their section 522 challenge within 120 days of the date of the initial denial notice from the contractor.**

68 Fed. Reg. 63,692, 63,695 (Nov. 7, 2003) (emphasis added).  In making this expansion, the regulations permitted beneficiaries, who both purchased and filed a claim for reimbursement with Medicare, to be able to challenge an LCD that caused the denial of the claim.  Therefore, the final regulation “expanded [the] definition of aggrieved party to include a beneficiary who received a service, but whose claim for the service was denied, extending an opportunity to that beneficiary to file a complaint under § 426.400 or § 426.500.”  68 Fed. Reg. at 63,693.

In the present case, the AP indicated that he purchased the device for which he claims the LCD denies coverage.  However, the AP has not filed a Medicare claim.  The AP should

**Page 6**

contact the Medicare contractor to determine how to file a claim.1
  If the Medicare contractor denies the claim, the AP may challenge the LCD.2
  However, the AP presently cannot make such a challenge.

III.  Conclusion

I conclude that the AP’s Complaint does not meet the timeliness requirement in 42 C.F.R. § 426.400(b).  Therefore, I must dismiss the Complaint because it is not acceptable/timely.  42 C.F.R. §§ 426.405(c)(2), 426.410(c)(2), 426.444(b)(2).


          /s/
        Scott Anderson

                      Administrative Law Judge
      1. Although there are limitations depending on whether service was obtained in the first nine months or the last three months of a calendar year, “the claim must be filed no later than the close of the period ending 1 calendar year after the date of service.”  42 C.F.R. § 424.44(a)(1); see also 42 C.F.R. § 424.32. back to note 1
                      2. The AP should note that the regulations precluded him from filing a new complaint challenging this LCD for six months from the date on this decision.  42 C.F.R. § 426.410(c)(3).  Therefore, if he files a Medicare claim and it is denied very quickly, an unfortunate situation may arise in which the AP is unable to file a new complaint within 120 days following the initial denial of the claim.  See 42 C.F.R. § 426.400(b)(2).  Therefore, the AP should attempt to coordinate the Medicare claim filing with the contractor to ensure that his claim is filed timely with the contractor but not so early that it will result in a situation where an administrative judge is compelled to dismiss a new complaint due to untimeliness.  See 42 C.F.R. § 426.444(b)(2). back to note 2 Back to top
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