Judge grants Temporary Restraining Order blocking new rules from taking effect. Lawsuit alleges Ohio Department of Health, “…failed to follow Ohio’s statutory rule-making process…” in rule changes that will, “…arbitrarily deny funding for potentially life-saving medications to Ohioans infected with HIV or suffering from AIDS-related symptoms.”
COLUMBUS, OH (November 3, 4:30pm Eastern)—BREAKING NEWS–The Court GRANTED plaintiffs’ Motion for a Temporary Restraining Order (TRO). The preliminary injunction hearing is scheduled for Tuesday, November 15 at 1:30 p.m. The current rules remain in place.
Three Ohio AIDS patients who are also longtime HIV/AIDS advocates filed a lawsuit against Theodore E. Wymyslo, M.D., Director of the Ohio Department of Health (ODH) seeking an injunction to, “…to enjoin the Ohio Department of Health and its Director from enforcing a rule which was not properly adopted…and which will arbitrarily deny funding for potentially life-saving medications to Ohioans infected with HIV or suffering from AIDS-related symptoms.” The complaint was filed Wednesday November 2nd, in the Court of Common Pleas, Franklin County, Ohio (Case number 11CVH-11-13646) on behalf of Ohioans Eddie Hamilton, William Booth and David Baker by attorneys at Dinsmore & Shohl LLP. The complaint also stated, “Because the Ohio Department of Health and its Director failed to follow Ohio’s statutory rule-making process, this Court must find that the proposed rule is unenforceable.”
In conjunction with the filing of the lawsuit and the application for (or granting of) a temporary injunction, the plaintiffs, together with advocates from AIDS Healthcare Foundation (AHF) and attorneys from Dinsmore & Shohl LLP, hosted a press conference (and teleconference) in Columbus, Friday, November 4th.
The catalyst for the legal action arose in late September 2011, when Ohio health officials took final steps to institute what are likely some of the most severe medical and financial-eligibility changes to a government medical assistance program nationwide— provisions that will ration health care in Ohio, and give the Director of the Ohio Health Department unilateral, arbitrary control over who does and who does not get ADAP. . The rule changes, which are scheduled to go into effect November 4th, drastically reduce individuals’ eligibility for Ohio’s beleaguered AIDS Drug Assistance Program (ADAP), one in the national network of federal and state funded programs that provide life-saving HIV treatments to low income, uninsured, and underinsured individuals living with HIV/AIDS.
“The medical and financial criteria that are at the heart of these rule changes in Ohio are murder by proxy, plain and simple,” said William Booth, one of the plaintiffs in the action and with the group, ‘Miami Valley Positives for Positives’ of Dayton. “While not every program can be secured with dollars, the cost containment procedures and restricted medical eligibility are forcing Ohio into a system where the state Department of Health will be deciding who lives or dies. That is why we have filed this legal action: to halt such a draconian—and what we believe illegal—action.”
“Changing Ohio’s medical-eligibility criteria for its ADAP, such as reducing the qualifying CD4 count from 350 down to 200, as this rule change does, is actually a form of rationing of lifesaving HIV medicines,” said David Baker, another of the plaintiffs in the action and with the group, ‘AIDS Awareness Ministry through the Church of Christ in Christian Union’ based out of the North Church on the North side of Columbus. “This change does nothing to solve the wait list and will interfere with individuals taking their medications consistently, putting them at risk for building up drug resistance to the medications and possibly getting sick. This is also not a cost-effective strategy for health officials, politicians—or Ohio taxpayers—as it is cheaper to prevent the progression of illness with medications than it is to pay for advanced illnesses that may require emergency room visits or hospital stays that come with far higher costs to the state down the road.”
“These new rules also permits the Director of the Ohio Department of Heath to unilaterally lower the program’s financial eligibility guidelines to an income as low as 100% of Federal Poverty Level— just $11,000 annually—even though that same individual’s lifesaving HIV medications may cost $12,000 or more per year,” said Eddie Hamilton, another of the plaintiffs in the action and with the group, ‘ADAP Educational Initiative’ based in Columbus. “Department of Health officials also waited until the last possible moment to file these rule changes, and the specific wording of these now-adopted changes were NOT included clearly and prominently in the actual text of the proposed changes, but were filed as appendices. Finally, the state failed to hold the required public hearings on these changes. Not only are these rule changes bad medicine, they seem to be bad legally.”
“State health officials did not follow the law while instituting these rule changes for its AIDS drug program, and as a result, the state now places an untold number of vulnerable Ohioans living with HIV or AIDS at risk of illness or even death,” said Thomas Hess, partner at Dinsmore and Shohl LLP. “As such, we are seeking temporary, preliminary and permanent injunctions from the Court to prevent Ohio from using illegal methods, such as the flawed rule change procedures cited, to control the state’s AIDS drug program costs by instituting such severe and potentially life-threatening financial and medical-based restrictions.”
“In addition, there appear to be potential conflicts with Ohio’s new rules from a federal standpoint and with certain grant deadlines and requirements,” said Michael Weinstein, President of AIDS Healthcare Foundation and a supporter of the lawsuit. “If these new rules violate federal and state law, the Ohio Department of Health’s rules must be invalidated by the Court and under the state’s Joint Committee on Agency Rule Review guidelines, as they exceed that rulemaking agency’s authority.”
General Background on the AIDS Drug Assistance Program and Ohio’s ADAP (from the lawsuit)
According to the U.S. Department of Health and Human Services, the Ryan White Program works with cities, states, and local community-based organizations to provide HIV-related services to more than half a million people each year. It is the largest federal program focused exclusively on HIV/AIDS care. The program is for individuals living with HIV/AIDS who have no health insurance (public or private), have insufficient health care coverage, or lack financial resources to get the care they need for their HIV disease. As such, the Ryan White HIV/AIDS Program fills gaps in care not covered by other funding sources.
The Ryan White Act created a number of programs, called Parts, to meet needs for different communities and populations affected by HIV/AIDS. Part B, which is at issue in this case, provides grants to all 50 states, plus U.S. territories, to improve the quality, availability, and organization of HIV/AIDS health care and support services. One component of the Part B grants is the AIDS Drug Assistance Program (ADAP), which provides medications for the treatment of HIV disease. Those medications can cost as much as $10,000-$12,000 per year per patient.
The Ohio Department of health first introduced rules to implement its Ryan White Program in 1991. To be eligible for benefits under Ohio’s Ryan White part B program, an individual shall meet all of the following requirements: (1) The individual must be an Ohio resident; (2) The individual must have a verified HIV infection; and (3) The individual or individual’s family must have a gross income, excluding taxes and any mandatory retirement deduction that meets the financial guidelines established by the director. The financial guidelines shall be based on the amount of funding available for the Ryan White part B program and percentage of the poverty income.
Ohio’s Current Rule contains no medical-based restrictions for eligibility, other than the requirement that the individual have a verified HIV infection.
Specifics of the Two Changes to Ohio’s ADAP-eligibility Rules (from the lawsuit)
- First, the Proposed Rule would give the Director of Ohio’s Department of Health unilateral discretion “at any time” to reduce the maximum gross family income threshold from 300 percent of FPL to as low as 100 percent of the FPL. If the Director exercised that authority, that would mean that, as of July, 2011, an individual with a gross income of just $11,000 per year would be earning too much to be eligible for Ohio’s Ryan White Program—even though that individual’s HIV medications might cost $12,000 per year.
- Second, the Proposed Rule would impose certain medical guidelines to determine the priority by which eligible Ohio recipients would receive Ryan White Program funds if there were a waiting list for those funds.
Procedural History of Adoption of Ohio’s Proposed Rule Chance (from the lawsuit)
- Neither the new medical guidelines nor the new financial guidelines are contained in the actual text of the Proposed Rule. Instead, they are detailed in Appendix A and Appendix B, respectively, which are attached to the current version of the Proposed Rule.
- (Such changes) requires a public hearing no less than 31 days and no more than 40 days after a proposed rule is announced. If any substantive changes occur to the proposed rule after the public hearing, the agency must hold an additional public hearing to receive comment on those substantive changes.
ADAP Waiting Lists Nationwide
As of October 27th, there were 6,689 individuals in 12 states on waiting lists to access lifesaving HIV/AIDS medications through ADAP. At present, Ohio has no patients on an ADAP waiting list, although over the past year, the state has had hundreds waiting for help from ADAP at times—with a high of 485 Ohioans on its ADAP waiting list as of June 30, 2011.
While Ohio’s proposed rule changes might appear to initially save the state some money in the short term, it ultimately would lead to far higher medical costs to the state as those disenfranchised AIDS patients became ill and seek emergency care at hospitals around the state—something far more costly and far less clinically appropriate.
Nationwide, ADAPs serve over 165,000 people, accounting for one third of people on AIDS treatment in the U.S. Unfortunately, the need for these programs expands every year, as more and more people become infected and diagnosed with HIV/AIDS; each year thousands of newly diagnosed HIV patients turn to ADAPs because they cannot afford their medicines.