In re LCD Complaint: Urological Supplies (LCD No. L33803), DAB CR6260 (2023)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

I must dismiss the complaint filed by the Aggrieved Party (AP) challenging local coverage determination (LCD) L33803.  As explained below, the complaint failed to meet a necessary requirement in order for it to be considered acceptable.

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 an 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” may file a complaint challenging the validity of an LCD.  42 C.F.R. § 426.320.

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After receiving a complaint, an administrative law judge must first determine if the complaint is valid and acceptable under the requirements in 42 C.F.R. § 426.400.  42 C.F.R. §§ 426.405(c)(1), 426.410(b).

In the present case, the AP filed correspondence through the mail, received on January 30, 2023, which the Civil Remedies Division (CRD) docketed as a complaint challenging the validity of LCD L33803.  CRD assigned the case to me for adjudication.

A review of the AP’s complaint revealed that it did not include clinical or scientific evidence to support the complaint.  42 C.F.R. § 426.400(c)(6).  I notified the AP of this conclusion in an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated February 9, 2023.  In the Order, I advised that the AP’s complaint was missing the following information that was necessary to constitute a valid LCD complaint:

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.  This can include articles from medical journals or healthcare publications.

The Order stated that the AP had one opportunity to amend the complaint under 42 C.F.R. § 426.410(c)(1).  I advised that if the AP did not submit an acceptable amended complaint, then I must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  My Order directed the AP to submit a valid amended complaint within 30 days of the date of the Order.

To date, CRD has not received a response from the AP.

II.     Discussion

The regulations provide the following rules for complaints that are not acceptable under the regulations:

(1) If the ALJ determines that the complaint is unacceptable, the ALJ must provide the aggrieved party (or parties) one opportunity to amend the unacceptable complaint.

(2) If the aggrieved party (or parties) fail(s) to submit an acceptable amended complaint within a reasonable timeframe as determined by the ALJ, the ALJ must issue a decision dismissing the unacceptable complaint.

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(3) If a complaint is determined unacceptable after one amendment, the beneficiary is precluded from filing again for 6 months after being informed that it is unacceptable.

42 C.F.R. § 426.410(c)(1)-(3).

The AP failed to file an amended complaint in response to my February 9, 2023 Order.  Thus, this complaint remains unacceptable within the terms of 42 C.F.R. § 426.410(b).  Accordingly, I must dismiss the complaint.  42 C.F.R. § 426.410(c)(2).  The AP cannot file a new complaint for six months.  42 C.F.R. § 426.410(c)(3).

III.     Conclusion

I dismiss the AP’s complaint because it is not acceptable under the regulations.