2006.08.10 CR1489, In re CMS LCD Complaint: Local Medical Review Policy (LMRP) Multiple Myeloma. .

1. The amended complaint includes copies of Medicare Summary Notices for the following dates of service: 2/22/05, 3/15/05, 4/14/05, 6/13/05, 7/7/05, 8/8/05, 9/27/05, and 10/27/05. Each notice is for pharmacy services provided by Indian River Village Pharmacy, Indian River, Michigan, and each notice indicates that the service was a "non-covered item or service."

2. Medicare provided no prescription drug coverage prior to the Medicare Prescription Drug Improvement and Modernization Act of 2003, Public Law 108-173, codified at 42 U.S.C. � 1395w-101 et seq.

3. The regulation provides that an "aggrieved party" may appeal an ALJ decision dismissing a "complaint regarding an LCD." 42 C.F.R. � 426.465(a)(2). I have concluded that the complainant is not an "aggrieved party" and that no LCD is at issue in this case. Therefore, arguably, there is no basis for an appeal. I assume, however, that the regulations contemplate that a party may seek review of my conclusions on these points.

CASE \| DECISION \|JUDGE \| FOOTNOTES
Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division
IN THE CASE OF
SUBJECT: In re CMS LCD COMPLAINT: Local Medical Review Policy (LMRP) Multiple Myeloma.	DATE: August 10, 2006
	Docket No.C-05-249 Decision No. CR1489

DECISION	...TO TOP
DECISION DISMISSING CASE This matter is before me based on a complaint filed by a Medicare beneficiary (the complainant) on February 28, 2005. After reviewing the complaint filed by the complainant, I determined that it failed to meet the standards for an acceptable complaint challenging a Local Coverage Determination (LCD) as enumerated in 42 C.F.R. � 426.400. Accordingly, as required by 42 C.F.R. � 426.410(c)(1), I afforded the complainant the opportunity to submit an amended complaint which would satisfy the regulatory requirements. I provided that opportunity by Order issued November 4, 2005. Pursuant to that Order, on December 14, 2005, the complainant timely submitted an amended complaint. However, my review of the amended complaint leads me to conclude that it is still unacceptable. Therefore, in accordance with 42 C.F.R. �� 426.410(c)(2) and 426.444(b)(3), I am required to dismiss the complaint. The primary reason that the complaint remains unacceptable is that the complainant is not an "aggrieved party" because he does not meet one of the criteria set forth in the regulation at 42 C.F.R. � 426.110. Moreover, even if I were able to conclude that the complainant was an "aggrieved party," the complaint would still be unacceptable because it fails to meet some of the requirements set forth in 42 C.F.R. � 426.400. The regulations require that an administrative law judge's (ALJ's) decision contain certain provisions. 42 C.F.R. � 426.450. Pursuant to 42 C.F.R. � 426.450(a), my decision must include findings. My findings in this case are set out in the two numbered headings. The regulations, at 42 C.F.R. � 426.450(b), require that an ALJ's decision contain certain other information. This decision contains the information required by 42 C.F.R. � 426.450(b)(1), (2), (3)⁽¹⁾ and (6). Because I am dismissing this case on jurisdictional grounds, the information required by 42 C.F.R. � 426.450(b)(4) and (5) is not relevant to my decision and/or is not a part of the record, and is not included for that reason. *1. The amended complaint is not acceptable because it was not filed by an "aggrieved party."* The first step I must take in evaluating whether the amended complaint is acceptable under the regulations is to determine whether the complaint has been submitted by an "aggrieved party." 42 C.F.R. � 426.410(b)(1). To be an "aggrieved party," as defined in the regulations, a person must satisfy three criteria: 1) the person must be entitled to Medicare benefits; 2) the person must be in need of coverage for a service that has been denied based on an applicable LCD; and 3) the person must have documentation of the need for the service from his or her treating physician. 42 C.F.R. � 426.110 (emphasis added). Both the complainant's original complaint and his amended complaint contain information showing that he is a Medicare beneficiary. This information satisfies the first criterion. The complainant also included with his original complaint a copy of a letter from his physician documenting the need for treatment with Thalidomide. The physician's letter satisfies the third criterion. As I indicated in my Order of November 4, 2005, however, the criterion that was not met in the original complaint is the requirement to show that the service at issue was denied based on an applicable LCD. The amended complaint fails to remedy this defect. On the contrary, in correspondence dated November 26, 2005, the complainant enclosed documentation which convinces me that this dispute does not concern an LCD, but rather a demonstration project under which prescription drug benefits were made available to some Medicare beneficiaries in advance of implementation of the new Medicare prescription drug benefit which became effective in 2006.⁽²⁾ The complainant's correspondence enclosed a copy of a New York Times article, dated June 25, 2004, which the complainant located on the internet. The article is entitled, "Lottery Planned for Test of Medicare's New Drug Coverage." The article describes a plan under which the U.S. Department of Health and Human Services, which administers Medicare, would conduct a lottery to select 50,000 Medicare beneficiaries suffering from cancer and other serious diseases to participate in a preview of the new Medicare drug benefit. The deadline to apply to participate in the lottery was September 30, 2004, according to the article. The article quotes the Secretary of Health and Human Services as having estimated that as many as 600,000 beneficiaries might be eligible to compete for the 50,000 slots. The article indicates that Thalidomide for the treatment of multiple myeloma was included among the drugs that would be covered under the demonstration project. Thalidomide is the treatment for which the complainant seeks coverage in his complaint. In his amended complaint, the complainant states: My complaint is that my physician, pharmacist, and Congressman . . . , as well as the Medicare carrier and Medicare referral lines were all asked to help me. None of these people or agencies were aware of the [Medicare] demo program - even though Medicare claims that all of the providers were notified of a demonstration project for Thalidomide. My wife and I came across the information by accident on the internet. I applied to the program in Nov. 2005, however the program was ending. I was only able to obtain one month of Thalidomide at a reduced rate. I feel it [is] grossly unfair that the [Medicare] carrier, AdminiStar Federal denied payment of my Thalidomide, and never referred me to the demonstration program! The cost is in the catastrophic range, and I met all the criteria of chemotherapy, need and eligibility. I am appealing for reimbursement . . . so that part of my financial burden of the last year can be reimbursed. As this excerpt makes clear, the relief the complainant is seeking is to be retroactively included in the demonstration project. As is also apparent, the complainant does not contend that he was denied coverage for his Thalidomide based on an LCD. 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. 42 C.F.R. � 400.202. Prior to the effective date of the Medicare prescription drug benefit, a determination that Thalidomide, as a prescription drug, was not a covered service under Medicare would have been based on an exclusion of coverage under the Medicare statute, rather than on a determination by an individual intermediary or carrier that the service was not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. the complainant's amended complaint implicitly confirms his understanding of this point, since he acknowledges that the only way he could have received payment for Thalidomide during 2005 would have been to participate in the demonstration project. My jurisdiction in this case depends upon the existence of an LCD which a beneficiary who needs the treatment or service governed by the LCD seeks to challenge. As the preceding discussion makes clear, the complainant's dispute with the Medicare carrier does not arise from the application of an LCD, but rather from the carrier's failure to inform him that he was eligible to apply for the demonstration project. The complainant's frustration with the carrier's failure to inform him of the existence of the demonstration project is understandable. However, the regulations do not authorize me to undertake any action with regard to the demonstration project. Because the complainant has not identified an LCD as the basis for the carrier's denial of coverage for Thalidomide, he is not an "aggrieved party" under the regulations. Because the complainant is not an "aggrieved party," I am required to dismiss the amended complaint. 42 C.F.R. � 426.444(b)(3). 2. Even if the amended complaint had been filed by an "aggrieved party," it is nevertheless unacceptable because it fails to include all required elements, and is subject to dismissal for that reason. Even assuming I concluded that the complainant was an "aggrieved party" within the meaning of the regulations, I would still be obligated to examine the amended complaint to determine whether it meets the requirements for a valid complaint set forth in 42 C.F.R. � 426.400. 42 C.F.R. � 426.410(b)(2). For the reasons explained below, I conclude that the amended complaint is unacceptable because it fails to include several elements required by 42 C.F.R. � 426.400. In such a situation, the regulations do not permit a second amendment of the complaint and, instead, direct that I " . . . must issue a decision dismissing the unacceptable complaint." 42 C.F.R. � 426.410(c)(2) (emphasis added). In my Order of November 4, 2005, I directed the complainant's attention to certain provisions of 42 C.F.R. � 426.400 that I had concluded his amended complaint needed to address. The amended complaint fails to address these points adequately. First, the amended complaint fails to provide the LCD identifying information required by 42 C.F.R. � 426.400(c)(4). While the name of the Medicare carrier can be identified from the amended complaint, the amended complaint fails to include the title of the LCD, and the specific provision or provisions of the LCD that the complainant is challenging. Second, the amended complaint fails to explain why the complainant believes that the challenged provisions of the LCD are not valid, as required by 42 C.F.R. � 426.400(c)(5). Third, the amended complaint fails to include clinical and/or scientific evidence on which the complainant relies to show that the challenged provisions of the LCD are not valid, as required by 42 C.F.R. � 426.400(c)(6). Of course, these defects in the amended complaint follow from the fact that there is no LCD at issue in this case, as I have discussed above. For the reasons stated, the amended complaint is unacceptable because it has not been filed by an "aggrieved party" as required by 42 C.F.R. � 426.410(b)(1). Accordingly, pursuant to 42 C.F.R. � 426.444(b)(3), the amended complaint must be, and it is DISMISSED. Further, the amended complaint fails to comply with the requirements of 42 C.F.R. � 426.400, as incorporated by reference in 42 C.F.R. � 426.410(b)(2). For that reason, pursuant to 42 C.F.R. � 426.410(c)(2), the amended complaint must be, and it is DISMISSED. Pursuant to 42 C.F.R. � 426.465, the complainant has 30 days from the date of this decision to file an appeal with the Departmental Appeals Board.⁽³⁾
JUDGE	...TO TOP
Richard J. Smith Administrative Law Judge
FOOTNOTES	...TO TOP
1. The amended complaint includes copies of Medicare Summary Notices for the following dates of service: 2/22/05, 3/15/05, 4/14/05, 6/13/05, 7/7/05, 8/8/05, 9/27/05, and 10/27/05. Each notice is for pharmacy services provided by Indian River Village Pharmacy, Indian River, Michigan, and each notice indicates that the service was a "non-covered item or service." 2. Medicare provided no prescription drug coverage prior to the Medicare Prescription Drug Improvement and Modernization Act of 2003, Public Law 108-173, codified at 42 U.S.C. � 1395w-101 et seq. 3. The regulation provides that an "aggrieved party" may appeal an ALJ decision dismissing a "complaint regarding an LCD." 42 C.F.R. � 426.465(a)(2). I have concluded that the complainant is not an "aggrieved party" and that no LCD is at issue in this case. Therefore, arguably, there is no basis for an appeal. I assume, however, that the regulations contemplate that a party may seek review of my conclusions on these points.
CASE \| DECISION \| JUDGE \| FOOTNOTES