AAPD Plaintiff in Lawsuit Filed Today Against the U.S. Department of Health and Human Services (HHS)
Organizations and Individuals Seek to Enforce Right to Appeal Medicare Ruling on Treatment for Age-Related Macular Degeneration (AMD)
August 6, 2002

FOR IMMEDIATE RELEASE
Contact: Andrew J. Imparato
(800) 840-8844

WASHINGTON, DC, August 6, 2002- This morning, the American Association of People with Disabilities (AAPD) participated in a press conference at the National Press Club in Washington, DC, to announce it was a plaintiff in a lawsuit filed first thing today in federal court challenging the failure of the Department of Health and Human Services (HHS) to implement an appeals process for National Coverage Determinations (NCDs) as required by Congress. Other plaintiffs are the American Council of the Blind (ACB) and the Gray Panthers, along with Medicare beneficiaries Lois Jalbert, Robert Kennell and Barbara McAuliffe.

"This lawsuit is important for individuals who have age-related macular degeneration (AMD), but also for everyone. When the Centers for Medicare and Medicaid Services' (CMS) chose to reverse the October 2001 decision to expand Medicare coverage for Visudyne, which is the only effective treatment currently available to treat AMD, then it is obvious they were not looking down the line at potential tax savings, where instead they would, with continued treatment, be enabling people with disabilities to continue to work," said Andrew J. Imparato, AAPD President and CEO, at this morning's press conference. "Instead, with this reversal they are continuing to trap people with disabilities-- they are trapping them in poverty, in institutions, and in their homes. With this lawsuit, we are giving the Administration and HHS, and President Bush and Secretary Thompson, the opportunity to prove their previous commitments to people with disabilities and to be accountable to the beneficiaries they are here to serve."

AMD is a disease of the elderly, and as such, a major concern for the insurance industry. As explained by AAPD, we compel CMS to abide by the law. Through this lawsuit, the plaintiffs are asking HHS and CMA to let Medicare and Medicaid beneficiaries to be heard.

"We're dealing with a very basic bodily function here: sight. For Medicare and Medicaid beneficiaries to be denied the opportunity for an appeal is intolerable.," said Charles Crawford, Executive Director of the American Council of the Blind, at the press conference. "This treatment is critical, but what the recent reversal is telling us if that if you can pay for the treatment, fine; but if you cannot afford to pay for the treatment, then go blind."

AAPD, ACB and the Gray Panthers joined together with the purpose of protecting the rights of Medicare beneficiaries and to challenge the Centers for Medicare and Medicaid Services' (CMS) erroneous decision to deny national Medicare coverage of ocular photodynamic therapy (OPT) with verteporfin ("Visudyne") for the treatment of age-related macular degeneration (AMD) with occult lesions.

According to AAPD and its fellow plaintiffs, CMS, by reversing its October 2001 decision to expand Medicare coverage for Visudyne, is vehemently denying the beneficiaries access to the only effective treatment available to treat AMD, the leading cause of blindness in people aged 50 and over.

In December 2000, Congress passed the Medicare, Medicaid and SCHIP Benefits and Improvement Act of 2000 (BIPA) by a vote of 292-60, and it was subsequently signed into law by President Clinton as Public Law Number 106-554 (codified at 42 U.S.C. § 1395ff). Section 522 of BIPA creates for the first time a right of "any aggrieved party" to challenge a Medicare National Coverage Decision (NCD). An NCD is a determination by HHS with respect to whether or not a particular item or service is covered nationally by Medicare. Under Section 522, once an aggrieved party challenges an unfavorable NCD, it "shall be reviewed by the Departmental Appeals Board of the Department of Health and Human Services." Congress mandated that Section 522 take effect and apply to any NCD made on or after October 1, 2001.

Nearly a year after the congressionally-imposed deadline for compliance with BIPA, HHS has failed to implement the appeals process as required under Section 522, and beneficiaries continue to be denied their right to appeal.

Instead of implementing the required appeal process, CMS issued an order to the Departmental Appeals Board to forward any appeals to a CMS employee who was told to docket them and "do nothing further." So when plaintiffs Jalbert, Kennell and McAuliffe tried to appeal HHS's decision to not cover Visudyne therapy, their appeals were docketed and left to gather dust until such time when HHS chooses to implement an appeal process. And, time is the one thing that people with AMD cannot afford. The disease, whose causes are not yet well understood, can progress quickly and result in such dramatic vision loss that a person can become legally blind within a short time of initial diagnosis.

As a result of HHS's refusal to establish a congressionally mandated appeals process for NCDs, the Plaintiffs, as well as many elderly and disabled patients, are unable to obtain critically needed medical procedures because of NCDs based on scanty evidence, questionable standards or stale information.

Said Crawford, "It's nothing short of an outrage when the agency set up to provide for health care won't even hear the simple request for reconsideration of a decision that puts the eyesight of the Medicare eligible elderly on the chopping block of administrative arrogance."

Added Imparato, "The sooner such erroneous policies are reviewed and reversed, the fewer beneficiaries will suffer harm. It is important for all Medicare coverage decisions to be reached in a rational manner that is supported by the available scientific evidence. In order to achieve this goal, CMS must be held accountable for its decisions."

To compel HHS to implement Section 522 of BIPA, Plaintiffs are suing HHS and CMS, seeking a writ of mandamus as well as preliminary injunctive relief. Added Grant P. Bagley, Arnold & Porter, Counsel for the Plaintiffs, "Congress recognized the need for Medicare beneficiaries to be able to challenge the policies that affect them. It is time for HHS to implement the process Congress created. We welcome the opportunity to fight to protect this important beneficiary right." He concluded his remarks at the press conference by announcing that he had been contacted by numerous additional national organizations wishing to join the lawsuit.

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