In re LCD Complaint: Assays for Vitamins and Metabolic Function, (L34914), DAB CR6397 (2023)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

For the reasons stated below, I must dismiss the Complaint challenging local coverage determination (LCD) L34914.

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.

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.

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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 [(national coverage determination)], 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).

The Civil Remedies Division (CRD) of the Departmental Appeals Board received correspondence dated October 17, 2022, from Dr. Megan J. Schlichte challenging LCD L34914 with respect to her patient, T.L.  In the letter, Dr. Schlichte stated that the "letter serves as my request for appeal of the inappropriate decision of the insurance company to deny coverage of laboratory testing . . ."  Dr. Schlichte explained that due to T.L.'s history of "multiple invasive melanomas as well as squamous cell carcinomas," his 20-pound weight loss over a period of a few short months prompted Dr. Schlichte to order several labs "to work up [T.L's] very concerning weight loss, concerning for metastatic cancer."  Based on the contents of the letter, it appears that Dr. Schlichte may be acting as a representative for T.L. and is challenging the LCD regarding the diagnostic lab claims enclosed with the letter.  Therefore, for purposes of this decision, I construe Dr. Schlichte's letter as an LCD Complaint.

After receiving the complaint, I determined that the complaint was timely but not acceptable under the requirements in the regulations.  In a September 20, 2023 Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), I first informed Dr. Schlichte that if she is acting as the aggrieved party's (AP's) representative, she must file a written authorization signed by T.L. appointing her as representative as well as additional identifying information for T.L. to confirm that T.L. is an AP.  Order at 3.  I then stated that the AP had 30 days to file a valid amended complaint that contained the following required information under 42

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C.F.R. § 426.400:

• Beneficiary-identifying information.  The AP must provide the beneficiary identifying information;
• Written authorization.  If Dr. Schlichte is acting as T.L.'s representative, then a copy of a written authorization to represent T.L. must be submitted;
• 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 T.L. 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.  Order at 4-5.

The AP's valid amended complaint was due October 20, 2023.  As of this date, the AP has not filed a valid amended complaint.

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 and the AP has failed to file an acceptable amended complaint within 30 days from my Order.  The regulations do not allow me to accept an incomplete complaint.  42 C.F.R. §§ 426.410(b)(1) and (2); see generally 42 C.F.R. §§ 426.100 through 426.490.  The regulations give an aggrieved party one opportunity to amend the complaint.  42 C.F.R. § 426.410(c)(1).  If the aggrieved party does not submit an acceptable amended complaint, then I must issue a decision dismissing the unacceptable complaint.

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In the present case, Dr. Schlichte indicated that the AP received the testing at issue and now seeks coverage under LCD L34914.  However, the 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. Schlichte acting as T.L.'s representative; the specific provision(s) of the LCD adversely affecting T.L. 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.

III.  Conclusion

I conclude that the AP's Complaint does not meet the requirements in 42 C.F.R. § 426.400, and the AP has failed to submit an acceptable amended complaint within the timeframe determined.  Therefore, I must dismiss the Complaint, because it is not acceptable.  42 C.F.R. §§ 426.405(c)(2), and 426.410(c)(2).