SUBJECT:

In re CMS LCD Complaint:

Home Application of Mechlorethamine for T-Cell Lymphoma.

DECISION

Dismissal is required for lack of jurisdiction.

I. PROCEDURAL HISTORY

The aggrieved party, in a letter to the Departmental Appeals Board (the Board) dated November 28, 2001, complained that Medicare denied payment for her prescriptions for Nitrogen Mustard, also known as Mechlorethamine (topical) and Mustargen, which she applied herself at home, but Medicare would pay for more expensive hospital administration of the same medication. The aggrieved party's frustration is apparent in her letter. She indicates she made numerous contacts with her Congressman, the Congressional Medicare Liaison, and calls to "every telephone number in the 'Medicare and You 2002' booklet." The Board treated the aggrieved party's complaint as a challenge to a Medicare National Coverage Determination and, on January 10, 2002, docketed the complaint as case A-02-26. In a heated letter dated June 5, 2002, the aggrieved party's husband emphasized the complaint as follows:

A) MEDICARE DOES NOT COVER MUSTARGEN.
B) IT DOES IF YOU GO TO THE OUTPATIENT DEPT. 365 DAYS PER YR FOR APPLICATION - $100,000⁰⁰ +
C) MUSTARGEN HAS BEEN PRESCRIBED FOR OVER 25 YEARS. WHERE IS THE F.D.A.?
D) SELF APPLICATION AT APROX $980⁰⁰ PER YR IS NOT COVERED. THIS IS CRIMINAL

Subsequent letters in the file reflect, in addition to the foregoing complaints, that Merck & Company, Inc. in 2002 had a shortage of the medication for home application.

The aggrieved party was advised by a letter from the Board dated December 16, 2003 ⁽¹⁾, that she was being given the opportunity to amend her complaint because her complaint did not meet regulatory requirements. The aggrieved party filed her amended complaint by letter dated January 14, 2004. She again emphasized that "THE PROBLEM IS MEDICARE DOES NOT COVER MY MEDICATION - NOR DOES OUR SECONDARY INS CO." The aggrieved party also realleged that, while Medicare pays for out-patient administration of the medication at a hospital, Medicare does not cover the cost of a prescription for home application of the medication. She also complained about the shortage of the medication which she attributed to the fact that Merck was the only manufacturer. The aggrieved party provided medical evidence indicating her need for the medication. However, the aggrieved party never identified any National Coverage Determination (NCD) that applied to prevent Medicare from paying for the medication. By letter dated July 7, 2004, the Board advised the aggrieved party that her attempted amendment of her complaint was deficient because she did not identify a National Coverage Determination (NCD) that was being applied to prevent Medicare from paying for her prescription. The Board advised the aggrieved party that she could further amend her complaint by August 20, 2004. The Board letter suggested that the aggrieved party investigate whether a Local Coverage Determination (LCD) was being applied against her and, if so, she might request a hearing by an administrative law judge (ALJ). The Board advised the aggrieved party that her complaint was being sent to the Civil Remedies Division (CRD) so that review by an ALJ could begin immediately. The Board also sent the aggrieved party some information regarding a Medicare demonstration project under which Medicare would pay for the home administration of some medications, but not Mustargen. The aggrieved party never did file with the Board an amended complaint that identified a NCD that was being applied to deny her Medicare coverage for her Mustargen prescriptions.

On July 29, 2004, the CRD acknowledged receipt of the aggrieved party's complaint from the Board and the case was assigned to me for hearing and decision. A letter issued at my direction on September 23, 2004, advised the aggrieved party that I understood her complaint to be that Medicare had denied her payment for her prescription for Mustargen. The letter attempted to explain the limited nature of my jurisdiction or authority to review complaints related to denial of payment by Medicare and to provide a remedy. The letter explained what the aggrieved party must allege and file in order to file a proper complaint that would allow me to review her case and possibly provide her some relief or, at least, an answer.

The aggrieved party responded by letter dated October 20, 2004. She explained that her complaint is that Medicare will not pay for a prescription for Mustargen for home application but will pay for application of the medication at the hospital. The aggrieved party again expressed frustration with the Medicare system and the failure to address her concerns. To ensure that the aggrieved party was not confused about what was required by my letter of September 23, 2004, we sent her a letter dated October 22, 2004, in an attempt to clarify matters and we provided her a copy of the applicable regulations.

I directed that the Centers for Medicare & Medicaid Services (CMS), which administers the Medicare program, be contacted to determine whether or not there is any LCD in effect in the State of Ohio, where the aggrieved party resides, that might affect payment for a prescription for Mustargen for home application. The inquiry of CMS was made by letter dated November 8, 2004, a copy of which was provided to the aggrieved party. The CMS response was made by Beth Giebelhaus, Director, Division of Medical Review, Program Integrity Group, by letter dated November 22, 2004. Ms. Giebelhaus confirmed that there is no LCD in effect in Ohio that affects Medicare coverage for the home application of Mustargen.

On January 13, 2005, I issued an order for the aggrieved party to show cause by February 1, 2005, why her complaint should not be dismissed for lack of jurisdiction as she has never shown that she was aggrieved by the application of a LCD to deny her coverage. The aggrieved party responded by letter dated January 19, 2005. The aggrieved party advised me that, at some unspecified time in the past, she submitted a claim to Medicare and "IT WAS DENIED AS A 'NOT COVERED ITEM.'" She again reminded me that, while Medicare will pay for the daily administration of Mustargen at the hospital on an out-patient basis, Medicare will not pay for a prescription for Mustargen that she applies herself at home. The aggrieved party also reminded me of her frustration with the Government. The aggrieved party did not identify a LCD that was being applied to deny her payment by Medicare for a prescription for Mustargen.

II. DISCUSSION

The aggrieved party first complained to the Board about the fact that Medicare would not pay for her prescription for Mustargen over three years ago. The Board never actually ruled on the aggrieved party's complaint, but correspondence clearly shows that the Board found itself without jurisdiction because the aggrieved party could not point to a specific NCD that was being applied to deny her payment. The Board attempted to help the aggrieved party understand the process and even passed the case directly to the CRD for a determination as to whether there was any ALJ jurisdiction or authority to help the aggrieved party.

Just like the Board, however, my jurisdiction or authority to review and decide whether or not the aggrieved party is entitled to some relief is limited. Pursuant to the regulations, I have jurisdiction or authority to review a complaint such as the aggrieved party's only if she is denied payment by Medicare due to the application of a LCD. I have no authority to review or remedy an individual claim for benefits that is denied by Medicare on grounds other than the application of a LCD. 42 C.F.R. � 426.100 et seq. In this case, the aggrieved party has never alleged that a LCD was being applied against her and she has never produced or cited to a NCD or LCD that was applied to deny her Medicare coverage. Furthermore, CMS has affirmatively stated that there is no LCD that applies in the State of Ohio to home application of Mustargen.

I conclude I have no jurisdiction to act upon the aggrieved party's complaint. However, I have reviewed the aggrieved party's correspondence and, based upon her allegations, the answer to her complaint is apparent. She has, in the past, obtained prescriptions for Mustargen to apply herself at home. I do not doubt her assertion that administration of Mustargen at a hospital on an out-patient basis is available and that such treatment would be covered by Medicare. The aggrieved party wants to know why her prescription, which she applies herself, is not paid by Medicare but, if she went to the hospital for the treatment, it would be covered. The answer is simply that historically, Medicare (42 U.S.C. � 1395 et seq.) has not covered or provided reimbursement for prescription drugs, while it has provided coverage for treatment by a hospital. ⁽²⁾ The aggrieved party's complaint is not that she was denied coverage by Medicare, the problem is that Congress did not choose to include prescription drug coverage in Medicare, at least not at the time the aggrieved party was denied payment for her prescriptions. ⁽³⁾

III. CONCLUSION

For the foregoing reasons, this complaint is dismissed.

Keith W. Sickendick

Administrative Law Judge

1. Much of the delay in handling the aggrieved party's complaint resulted from the fact that the law changed regarding review of complaints such as hers was assumed to be, and there was a delay in processing such complaints until final procedural regulations were implemented on November 7, 2003. 68 Fed. Reg. 63,691-731 (Nov. 7, 2003).

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. Of course, it is the Congress that makes and amends the law and the Board and I have no ability to add prescription drug coverage when Congress chose not to.