In re LCD Complaint: MolDX: Genetic Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothombin, and MTHFR) (L36159), DAB CR5997 (2021)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

For the reasons stated below, I must dismiss the Complaint challenging local coverage determination (LCD) L36159.

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:

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.

Page 2

LCDs may be challenged under 42 U.S.C. § 1395ff(f) and 42 C.F.R. part 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. 

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).  

Dr. Edward Wos, a physician purporting to act on behalf of his patient K.S. (Aggrieved Party or AP), filed a Complaint with the Civil Remedies Division (CRD) by U.S. Mail on October 1, 2021, challenging LCD L36159.  CRD assigned this matter to me for adjudication.  After receiving the complaint, I determined that the complaint was not acceptable under the requirements in the regulations.  In an October 15, 2021 Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), I first informed Dr. Wos that if he is acting as the AP’s representative, he must file a written authorization signed by K.S. appointing him as representative.  I then stated that the AP had 30 days to file a valid amended complaint that contained the following: 

• Beneficiary-identifying information. The AP must provide the beneficiary identifying information set forth in 42 C.F.R. § 426.400(c);  
• Written authorization. If Dr. Wos is acting as K.S.’s representative, then a copy of a written authorization to represent K.S. must be submitted;

Page 3

• Timeliness Information. A complete copy of the initial denial notice that includes the date of the notice;
• LCD-identifying information. The specific provision(s) of the LCD adversely affecting K.S. as the AP;
• Aggrieved Party statement. A statement from the AP explaining why he thinks that the relevant provision(s) of the LCD is (are) not valid under the reasonableness standard; 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 also stated that the AP’s response had to be filed electronically through the Departmental Appeals Board Electronic Filing System (DAB E-File) unless the AP obtained a written waiver.  I further specified the following in relation to the necessary amendments above:

With respect to timeliness, I am unable to decide, based on Dr. Wos’s letter, as to whether the complaint is timely.  If Dr. Wos is filing an LCD challenge after K.S. received the service, the complaint was required to be filed within 120 days of the initial denial notice.  If, however, Dr. Wos is filing the LCD challenge before K.S. received the service, then the complaint must be filed within six months of the issuance of a written statement from K.S.’s treating physician.  I construe Dr. Wos’s letter as stating that Dr. Wos is K.S.’s treating physician and that K.S. required the genetic testing at issue.  However, the letter also indicates that K.S. has already received the testing and now seeks coverage under LCD L36159.  Because an initial denial notice was not submitted, I am unable to ascertain whether the complaint was timely filed.

The AP’s response to the Order was due November 15, 2021.  As of this date, the AP has not submitted a response to the order.

II.  Discussion

I am unable to conclude that the AP’s Complaint is acceptable, because it does not comply with all of the requirements in 42 C.F.R. § 426.400.  Specifically, it does not appear that the AP’s Complaint is timely filed, and the AP has failed to otherwise respond to my Order.  The relevant regulations provide:

Page 4

(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).  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, which obviously means 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 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

Page 5

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, Dr. Wos indicated that the AP received the testing at issue and now seeks coverage under LCD L36159.  However, the AP has not responded to the Order, much less presented evidence that he has filed a Medicare claim from which I can determine the timeliness of the Complaint.

Further, AP’s Complaint fails to include the following required information: beneficiary-identifying information as set forth in 42 C.F.R. § 426.400(c); written authorization of Dr. Wos acting as K.S.’s representative; the specific provision(s) of the LCD adversely affecting K.S. as the AP; a statement from the AP explaining why he thinks that the relevant provision(s) of the LCD is (are) not valid under the reasonableness standard; and 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.

Page 6

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).

I further conclude that the AP has failed to submit an acceptable amended complaint within the timeframe determined.  I therefore issue this decision dismissing the AP’s unacceptable complaint.  42 C.F.R. § 426.410(c)(2).