Medicare beneficiaries last week sued HHS and the Centers for Medicare and Medicaid Services in an effort to force the agency to establish a beneficiary appeals process mandated by Congress two years ago.
Filed in U.S. District Court in Washington on Aug. 6, the federal lawsuit specifically focuses on the CMS' denial to cover a particular vision therapy. But the impact of the lawsuit could be far-reaching for all beneficiaries, said the plaintiff's attorney, Grant Bagley, M.D., a partner at the Washington office of Arnold & Porter.
"It's a general issue-the Medicare beneficiary's right to appeal," said Bagley, who served as director of coverage and analysis for the CMS, then known as the HCFA, under President Clinton.
The CMS missed the Oct. 1, 2001, deadline required by the federal Beneficiary Improvement and Protection Act to create a process that would allow beneficiaries to appeal national coverage decisions by way of administrative law judges.
The CMS said it is working on the issue, while the plaintiffs say the CMS simply has no interest in implementing an appeals process.
Three Medicare beneficiaries, joined by the American Association of People with Disabilities, the American Council of the Blind and the Gray Panthers, want the court to order the CMS to follow the law. They have asked the court to hear their case by Aug. 31 or soon thereafter. At deadline, no hearing had been set.
"The principle is important not just for age-related macular degeneration but for anybody who could benefit from new technology," said Andy Imparato, president and chief executive officer of the AAPD.
The plaintiffs received support from a key Republican sponsor of the law mandating the appeals process-House Ways and Means Chairman Bill Thomas (R-Calif.)-late last week. "Medicare beneficiaries are being denied access to healthcare with no chance to appeal those decisions. This must change-it's the law," Thomas said in a written statement.
The CMS is writing a regulation for the mandated appeals process, an agency spokesman said.
"The department and the Centers for Medicare and Medicaid Services are working hard to bring uniformity and consistency to Medicare coverage policy," he said. He could not provide information on when the CMS might issue the regulation on the appeal process, nor on the progress or timing of the ruling.
But the law does not require a regulation and the administrative judges already exist in the HHS' appeals board, Bagley said.
Timing is of the essence for the three beneficiaries who sued. They soon could lose their eyesight because of the aggressiveness of their disease, Bagley said.
The vision coverage they seek nearly made it through the Medicare channels. Last October, the CMS announced its intention to cover the drug Visudyne for Medicare patients with a form of age-related macular degeneration that causes occult lesions. The CMS already covers the treatment for a form of the illness that causes classic lesions. In March, however, the CMS reversed its decision in a memo that stated "the scientific evidence is not adequate" for the occult lesion form of the illness.
When the beneficiaries filed their individual appeals, the CMS said it would take no action.
The action appears to be motivated by cost and not by science, Bagley said. He contended beneficiaries should be able to appeal. "The Congress gave beneficiaries the opportunity to at least have a hearing," Bagley said. "That is what we are seeking to do."
Beneficiaries already have a process to contest national coverage issues, the CMS spokesman said. If they provide new science and experts, the agency will review the coverage decision and decide whether it should reopen the case. "They didn't go through that process," the spokesman said.
Bagley argued the current science is sufficient. "The beneficiaries would like to appeal on the science that is available. That is what Congress said they could do," he said.
Beneficiary and consumer groups have spoken out in favor of the lawsuit against the CMS. "This is a case where the plaintiffs, along with many others, are harmed by the government's inaction," said Linda Golodner, president of the National Consumers League, a Washington-based advocacy group.