In re LCD Complaint: Leuprolide Depot Injection, CR6432 (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 LCD 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 December 7, 2023, from Dr. Paul L. Hyman on behalf of patient, S.G. I considered 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 a December 19, 2023 Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), I stated that the Aggrieved Party (AP) had 30 days to file a valid amended complaint that contained the following required information under 42 C.F.R. § 426.400:

• Beneficiary-identifying information.The AP must provide the beneficiary-identifying information that also confirms he meets the regulatory definition of an “aggrieved party”;
• Written authorization. If Dr. Hyman is acting as S.G.’s representative, then a copy of a written authorization to represent S.G. must be submitted;
• LCD-identifying information.The title of the LCD being challenged and the specific provision(s) of the LCD adversely affecting the AP;

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• 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.

II. Discussion

On January 11, 2024, Dr. Hyman's office filed an Amended Complaint with supporting documents. The Amended Complaint, however, also does not comply with all of the requirements in 42 C.F.R. § 426.400.

Among other issues, there is still no written authorization for Dr. Hyman to represent the AP in this matter. Although Dr. Hyman's office submitted documentation identifying the AP's co-guardians, there is no signed statement from any of those guardians authorizing Dr. Hyman to represent the AP in this matter.  The Amended Complaint also does not identify the specific provisions of an LCD adversely affecting the AP, let alone a statement explaining why the AP thinks those provisions are not valid under the reasonableness standard.  Finally, although the original Complaint cited two scientific articles, there are still no copies of those articles or other clinical or scientific evidence to support the Complaint.¹

Dr. Hyman's office argues in the Complaint that the leuprolide medication is medically reasonable and necessary for S.G., based on factors that are unique to his medical condition. Such arguments may properly be addressed in an appeal of specific claims in which the contractor has denied coverage for the medication. 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.

In reviewing the AP’s challenge to a generally applicable LCD here, I conclude that the Complaint does not meet the requirements in 42 C.F.R. § 426.400 and that the Amended

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Complaint is unacceptable. Therefore, I must dismiss the Complaint. 42 C.F.R. §§ 426.405(c)(2), and 426.410(c)(2). The AP may not file another complaint challenging the same LCD for six months. 42 C.F.R. § 426.423(c)(1).

Endnotes

¹ The Amended Complaint also does not confirm that S.G. is a Medicare beneficiary entitled to benefits under Part A or enrolled under Part B, or both, to meet the definition of “aggrieved party.” 42 C.F.R. § 426.110 (defining Aggrieved Party). As noted above, only individuals qualifying as an “aggrieved party” may file a complaint challenging the validity of an LCD. 42 C.F.R. § 426.320.