In re LCD Complaint: Cologuard Screening, DAB CR6583 (2024)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

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

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 LCDs as: 

• 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 postmarked September 27, 2024, from Rush University, signed by Sarah Kosinki, Nurse Practitioner, on behalf of patient, P.B.  I construed the correspondence as a complaint challenging an LCD and, after reviewing the complaint, determined that it was not acceptable under the requirements in the regulations.  In an October 18, 2024 Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), I stated that the Aggrieved Party (AP) had 30 days, until November 17, 2024, to file a valid amended complaint that contained the following required information under 42 C.F.R. § 426.400: 

• Written authorization.  If Rush University is acting as P.B.’s representative, then a copy of a written authorization to represent P.B. must be submitted pursuant to 42 C.F.R. § 426.400(c)(2)(v);  
• Timeliness information.  A complete copy of the initial denial notice that includes the date of the notice;
• Treating Physician’s written statement.  A written statement from the aggrieved party’s treating physician pursuant to 42 C.F.R. § 426.400(c)(3);

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• LCD-identifying information.  The title of the LCD being challenged and specific provisions of the LCD that adversely affect the aggrieved party pursuant to 42 C.F.R. § 426.400(c)(4);
• Aggrieved Party statement.  A statement explaining why the provisions of the LCD are not valid under the reasonableness standard pursuant to 42 C.F.R. § 426.400(c)(5); and
• Clinical or scientific evidence.  Copies of clinical or scientific evidence supporting the complaint and an explanation as to how such evidence “shows that the LCD is not reasonable” pursuant to 42 C.F.R. § 426.400(c)(6).  

The 30 days has elapsed, and to date, the AP or the AP’s representative has failed to file an amended complaint or any further response to my October 18, 2024 Order.

II. Discussion

Rush University’s Gastroenterology office argues in the Complaint that a Cologuard screening is medically reasonable and necessary for P.B., based on factors that are unique to her medical condition.  Such arguments may properly be addressed in an appeal of specific claims in which the contractor has denied coverage for the screenings.  For such claims, the AP may seek review by an administrative law judge of the Office of Medicare Hearings and Appeals (OMHA).  I do not have jurisdiction to review the denial of individual Medicare claims.  I have jurisdiction to review challenges to LCDs to determine whether coverage policies that are generally applicable on a contractor-wide basis are valid under the reasonableness standard. 

However, as addressed in my October 18, 2024 Order, 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 (outlining process, scope, and procedures for filing and consideration of Complaints against Local Coverage Determinations).  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.  The AP may then resubmit a new complaint after a regulatorily prescribed period of time, if still necessary.  42 C.F.R. §§ 426.410(c)(3), 426.423(a) and (c)(1).  

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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.  42 C.F.R. §§ 426.405(c)(2), and 426.410(c)(2).