Plan to fight HIV, hepatitis snarled in red tape

• It's been more than six months since Clark County first sought state approval for a needle exchange program.
• Key parts of the program's funding are waiting to be approved by the Indiana State Department of Health.
• Gov. Mike Pence might also weigh in on a nonprofit's role in funding Clark County's needle exchange.
• If the state and Pence do not approve the funding model, Clark County may be forced to start from scratch.

Clark County was among the first in Indiana to seek a needle exchange program to combat the county's spread of hepatitis C and the fear of an HIV outbreak. But nearly a year after agreeing to seek state approval, the county is still bogged down in a bureaucratic process.

There are several reasons community leaders say the program – which would place a heavy focus on disease testing, resources and treatment referrals – has been stalled.

The fate of the exchange is in the hands of the Indiana State Department of Health and now, the Courier-Journal has learned, with Gov. Mike Pence.

And for more than a year, speculation has quietly circulated among locals involved regarding the state's real or perceived distrust of international nonprofit AIDS Healthcare Foundation's role. Others have even questioned its public health motivations. State health officials, though, say those concerns are unwarranted.

In the meantime, the county of about 115,000 people remains among the state's worst for its number of hepatitis C cases, and last year it passed Jefferson County, Ky.'s overdose death rate per capita. Locals point to an increase in intravenous drug use – and with it the sharing of dirty needles – as a reason for Clark County's glaring statistics.

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"It's a scary thing to do," said Clarence Dupin, a 43-year-old recovering heroin addict in Jeffersonville, Ind. "Diseases are carried on those needles." Though he used to lie about being diabetic to get clean needles from pharmacies or buy them from dealers, he resorted to sharing a needle once because there was no other option.

Of Indiana's 92 counties, in the year since legislation was passed lifting the ban on needle exchanges, five counties have been approved and Scott County has been approved twice.

After needle sharing among intravenous drug users was blamed for Austin, Ind.'s HIV crisis last year, Clark County officials began to follow diligently the state's new process for getting its first needle exchange.

It took one day for Madison County's program to gain state approval. It took Wayne County three days, Fayette County a few weeks and Monroe County two months.

It's been almost a year since local officials began the process and more than six months since Clark County submitted a 200-page state application for a needle exchange.

Louisville has had an exchange program for a year, and of its more than 3,600 individual participants so far, nearly 7 percent, or more than 230 people, had Clark County zip codes.

“That’s further evidence for the need to do this in Clark County,” Dr. Kevin Burke, Clark County’s public health officer, said. “For everyone who does eventually participate, there’s a whole set of individuals equal in number to participants – or maybe even twice that – who aren’t involved.”

“When it comes to this issue, we really don’t have the luxury of time,” said Indiana Rep. Ed Clere, R-New Albany, who wrote the legislation ending Indiana's ban of syringe exchanges while on the House public health committee, where he once served as chairman.

'... the state doesn’t spell that out​.'

When Burke was first considering the option of a needle exchange, he asked the AIDS Healthcare Foundation – an international, billion-dollar nonprofit and one of several organizations that responded to Scott County's HIV crisis – to help fund the program. Clark County is facing a budget crisis, the health department has limited funding, and while the state can legally help pay for a syringe exchange program, there aren't funds allocated to do so.

AHF worked with Burke to draft the detailed application for the state. It outlines Clark County's crisis, its lack of funds, its community support and the exact procedures that would be used to run the exchange.

The application was sent to the state in December, and Indiana State Department of Health Commissioner Jerome Adams eventually sent it back asking for clarification on a few sections and for Clark County to submit a contract with AHF.

Adams said the state has to make sure nonprofits are abiding by state guidelines on needle exchanges.

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Carrie Lawrence, a post-doctorate fellow at the Indiana University Rural Center for AIDS/STD Prevention, worked with Monroe and Clark counties on their proposed programs. She attributes some of the slow approval process in both counties to their decision to fund needle exchanges through nonprofits.

In Monroe County, Bloomington nonprofit Indiana Recovery Alliance agreed to fund the exchange. When the application was sent to the state, officials similarly returned it and asked for a contract between the alliance and Monroe County’s health department.

“A memorandum of understanding wasn’t good enough,” Lawrence said. “Unless I’m missing it in the guidelines, the state doesn’t spell that out.”

In the Indiana State Department of Health’s guidelines for developing a syringe exchange program, it asks that states explain how the program will be funded but does not explicitly require a contract in those guidelines.

State leaders and politicians acknowledge that many rural counties are cash-strapped and have to look to nonprofits or other public health groups for funding. But as Monroe and Clark counties have faced delays because of their involvement with nonprofit groups, others haven't been treated the same way.

Madison County didn't even fully define where funding would come from, but said in its application that sources were being considered. A local hospital nonprofit was selected by Wayne County and Fayette County sought the help of Washington, D.C.-based group AIDS United.

'My hope is we can come to an understanding.'

Burke said attorneys worked out a contract with AHF, but a vital part of the foundation's funding structure might be at issue with the state.

AHF is asking the state to let it subsidize the cost of prescriptions through a mail-order pharmacy. The program, called 340B pricing, would let AHF obtain drugs at a lower cost than it sells them, and AHF would use the revenue to help pay for the Clark County exchange and other programs in Indiana.

To Burke's understanding, the state is seeking approval under a federal Ryan White HIV/AIDS Program that allocates dollars to states for prevention. According to the U.S. Health Services and Resource Administration, the state department of health is the only group in Indiana that gets the Ryan White classification under 340B permits.

There are more than 600 approved 340B permits in Indiana, though, including hospitals, Planned Parenthood, health departments and nonprofits. According to the U.S. Health Services and Resource Administration's 340B database, the AIDS Healthcare Foundation holds 46 similar permits in nine states – including those classified under the Ryan White program.

Burke said the state has been reluctant to give AHF 340B pricing under Ryan White, and has turned to Pence for guidance in the decision. If the state denies that approach, AHF has said might downsize Clark County plans.

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Whitney Engeran-Cordova, senior director of public health for AHF, said the organization doesn't have a large infrastructure to build on in Indiana, and the organization can't just spend thousands of dollars on a syringe exchange program in Clark County.

AHF's only presence in Indiana includes a clinic and pharmacy in Austin, and it sometimes sponsors events in Southern Indiana, including Jeffersonville's inaugural gay pride festival.

With 340B pricing, Engeran-Cordova said, drug companies would in large part pay for Clark County's syringe exchange.

"I'm not sure what I'd call it right now if it's not a roadblock," he said. "My hope is we can come to an understanding."

'We were told we had to not work with AHF'

Among reasons that aren't as straightforward as prescription pricing or contracts, AHF leaders, local advocates and officials have worried that Indiana's real or rumored dislike of the foundation could affect Clark County's application.

"We have nothing as a state against AHF or any organization that wants to engage," Adams from the state department of health said during a phone interview. "... the second thing to remember is we're a home-rule state. We have no control over who the counties can and can't partner with."

"I know there's a perception that it's AHF versus (the state department of health) or AHF versus (Indiana University Health)," Adams continued. "But that's not the case."

The first time the mega-nonprofit came to Indiana, AHF was jumping into Austin mid-HIV outbreak. Dr. William Cooke, Austin's lone physician, said he reached out to everyone -- the state department of health, Indiana University Health and AHF.

All three organizations responded, and things worked well for a while. Then, Cooke said, a decision was made and "we were told we had to not work with AHF." Cooke did not want to clarify who exactly made the decision.

"We needed help," Cooke said. "AHF was helping. I really didn't see any way that we couldn't accept their help. They've done more for the community than any other organization has."

Clark County's Burke said he was aware of some "bad blood" between the foundation and other organizations in Austin, but neither the state or AHF ever clarified what the exact issues were.

"There were these other organizations that came in (to Austin) like IU Health," Burke said. "They were in Dr. Cooke's office and had a falling out or disagreement."

Burke speculated that some of the disagreement may have been attributed to AHF's pharmaceutical operations. Others have pointed to AHF's history of involvement in high-profile lawsuits.

"But they're the largest AIDS foundation in the world with an international influence and presence," Burke said. "They're a respected organization, in spite of the criticism."

Engeran-Cordova with AHF said it can be jarring when a nonprofit of their size comes into a community the size of Austin. AHF runs syringe exchange programs, clinics and pharmacies internationally and in the U.S., including in Ohio.

"We didn't ask for a lot of permission," he said. "... (IU Health) had some ideas about how they wanted to do things, the state had their ideas, Cooke was the only doctor in town and we moved in quickly to support him. That became challenging."

In Scott County, the local health department runs its needle exchange, despite AHF's offer to pay for it.

Adams said it's important to separate AHF's work in Scott County with a new program in Clark County. He said if AHF crossed county lines and passed out needles in Scott County, not only would they be in violation of state law, but it could compromise Scott County's exchange.

Engeran-Cordova said AHF crossing county lines and breaking state law is a nonissue.

Adams continued to address whisperings about a strained relationship between the state and the nonprofit.

"The reality is, with any doctor or care provider, some people will choose to get their care with that doctor and some don't," he said. "There are some folks in Scott County who love Dr. Cooke and AHF and want to get their care there, and there are some who would like another choice. From the state's point of view, it's not my place or my desire to pick winners or losers.... AHF being there has been important. IU being there has been important."

'We really don't have the luxury of time'

As the state, AHF and the local health department tries to work out the issues, IV drug use in Clark County isn't slowing.

It’s been nearly a year since Clark County commissioners voted to approve Burke’s plan for a mobile needle exchange unit. Rep. Clere said he was at that commissioners meeting, and based on the legislation and what was presented, he expected a program to be in place at the end of last year or soon after.

"There's no question that Clark County has been experiencing an epidemic of hepatitis C, and there's widespread acknowledgement that a syringe exchange is an appropriate part of a comprehensive response, yet it's been six months?" Clere said. “... The fact that we’re approaching the mid-point of the following year is disturbing."

Burke also had a hand in getting the state's syringe exchange legislation passed. At Clere's request, Burke testified at a hearing on the legislation in March 2015. Clere said Burke is a respected voice on public health and syringe exchanges specifically, so it's odd it's taken so long to get an exchange approved in his own county.

Clere said he's learned a lot over the last year about some of the strengths and flaws in Indiana's legislation, which he said is full of compromises that helped get it passed, such as the one-year limit and state of emergency requirement. He thinks it might also be appropriate to reconsider the application process.

As other Indiana counties examine their options – as their commissioners vote and their health departments examine numbers – Clark County waits.

So do residents like Dupin, who travels every day to the only methadone clinic in the region. For himself, his friends and family – for the addicts he knows and loves – the future looks bleak.

"I don't know if they misunderstand us or they just want to turn their eyes to it," Dupin said. "They don't want to deal with it. It's easier to pretend that it doesn't exist than it is to face it head on and actually deal with the problem."

Reporter Lexy Gross can be reached at (502) 582-4087, or via email at lgross@courier-journal.com.