## Facts

- A university medical center treated 12 Medicare beneficiaries in 1999 for multiple myeloma using high-dose chemotherapy followed by autologous stem-cell transplantation (ASCT).
- The regimen included harvesting the patients’ stem cells, administering high-dose chemotherapy, and reinfusing harvested cells to counteract chemotherapy toxicity.
- Medicare guidance in effect at the time treated high-dose chemotherapy for multiple myeloma as covered, but did not cover ASCT for multiple myeloma until a later policy change in 2000.
- The fiscal intermediary denied reimbursement, treating both ASCT and the associated chemotherapy as noncovered.
- The Departmental Appeals Board (DAB) affirmed the denials, reasoning that the chemotherapy was “inextricably linked” to the noncovered ASCT and therefore also noncovered in this setting.
- The DAB also held the provider financially liable and found the beneficiaries not liable because the record lacked evidence of procedure-specific advance notice of likely noncoverage, despite general Advance Beneficiary Notices (ABNs).
- The provider sought judicial review after exhausting administrative remedies, and the parties filed cross-motions for summary judgment.

## Issues

1. Whether Medicare lawfully treated ASCT for multiple myeloma as noncovered in 1999.
2. Whether Medicare could deny payment for high-dose chemotherapy when furnished as part of a coordinated regimen culminating in a noncovered ASCT.
3. Whether the provider could shift financial liability to beneficiaries based on general ABNs, or instead remained liable due to insufficiently specific notice.

## Decision

- The court affirmed the Secretary’s decision (via the DAB) and denied the provider’s request for reimbursement.
- The court upheld the determination that ASCT for multiple myeloma was noncovered in 1999.
- The court upheld denial of payment for the high-dose chemotherapy because, in these cases, it was part of a single, integrated, noncovered course of treatment centered on ASCT.
- The court upheld the finding that beneficiaries were not liable and that the provider was liable because the ABNs and record did not show specific advance notice that these particular services would not be covered and would be the patients’ responsibility.

## Legal Principles

- In Medicare reimbursement disputes, courts review agency action deferentially and will uphold reasonable agency interpretations and coverage determinations unless arbitrary or capricious.
- Medicare may treat otherwise-covered services as noncovered when they are integral to, preparatory for, and clinically inseparable from a noncovered procedure within a coordinated treatment regimen.
- To impose beneficiary liability for noncovered services, advance notice must be sufficiently specific to the procedure and the anticipated denial; generic warnings that coverage “may be denied” are inadequate.
- Where coverage exclusions are clear in applicable Medicare guidance, providers are expected to know the limits and may bear financial responsibility if they furnish the services without providing adequate, procedure-specific notice.

## Conclusion

The court sustained the agency’s denial of Medicare reimbursement for 1999 ASCT for multiple myeloma and associated high-dose chemotherapy provided as part of a unified regimen, and it held the provider—not the beneficiaries—liable because the patients did not receive sufficiently specific advance notice to shift financial responsibility.


Bd. of Trs. of Univ. of Ark. v. Sec’y of Health & Hum. Servs., 354 F. Supp. 2d 924 (E.D. Ark. 2005)