Published November 24th, 2015 at 7:55 AM9 minute read
Signs of the toll amyotrophic lateral sclerosis has taken on Kelli Johnsen’s body are scattered throughout the living room of her Emporia, Kansas, home. A wheelchair in one corner. A lift in another. A walker near the television.
Next to her chair there’s an Eyegaze system — a screen that tracks her eye movement and blinks — that she uses to control the TV, lights and other devices. She can still move her hands, but not much.
Before she got sick, Johnsen, 45, was a critical care emergency veterinary technician and had a paper on tracheal trauma published in a veterinary trade magazine. Then she began struggling to hoist 60-pound animals onto operating tables. Then she started slurring her speech. Seven years ago a neurologist explained why, diagnosing her with ALS, also known as Lou Gehrig’s disease.
Though Johnsen now struggles to move and talk, her mind remains sharp. She spends six to eight hours a day using the Eyegaze to scour the Internet while researching medical breakthroughs that could save or at least prolong her life.
That’s how she heard about Eric Valor, a man with late-stage ALS who is in a trial for a drug made by a company called Genervon. Her face lights up when she talks about the improvement he reports in his breathing and swallowing.
“Last I heard, he had held on to the gains,” Johnsen says.
Johnsen would like to try the drug too, but it’s in the middle of U.S. Food and Drug Administration clinical trials. In fact, so many ALS survivors and their caregivers are interested in the medication that Genervon issued a news release in March updating them on its status. The company has applied to fast-track the drug through an accelerated approval FDA program. But if that’s not granted and it remains in Phase 3 clinical trials, it could be three more years before the drug hits the open market.
Johnsen doesn’t believe she can wait that long. People with ALS, statistically, are expected to live two to five years after their diagnosis.
Kansas lawmakers are promoting bills at the state and federal level intended to streamline the FDA approval process or let people like Johnsen bypass portions of it and access experimental drugs sooner. But some fear those efforts could allow profit-seeking drug companies and medical device manufacturers to rush products to market before anyone knows the potential risks or side effects.
Don Hill, a pharmacist and state representative from Emporia, was one of three legislators who promoted a ‘Right to Try’ bill last session. He’s also Johnsen’s representative in the Kansas House.
House Bill 2004 seeks to give Kansans with terminal illnesses access to drugs in the early phases of FDA clinical trials. It’s based on model legislation from the Goldwater Institute, a small-government advocacy think tank.
The bill did not get a House vote last year. But Kansas is in the middle of a two-year legislative cycle, Hill explains, which means the bill remains eligible for a vote after the Legislature reconvenes in January.
Hill — one of the calmest, most measured speakers in the Kansas Legislature — slowly and carefully explains the political landscape. The “Right to Try” bill in Kansas is crafted for a narrow set of very sick people, he says. But the fear is that other legislators will try to broaden it with amendments if it comes up for a House vote.
For example, Hill says Rep. Mario Goico, a Wichita Republican, would like to extend access to experimental drugs to patients like his wife, who has late-stage cancer. Hill says he understands Goico’s position, but some of his House colleagues already were concerned about the medical ethics of the bill. Opening untested drugs to a wider patient population would have increased those concerns.
“The bottom line is the speaker — and I didn’t necessarily disagree — decided to hold it,” Hill said.
In a phone interview a few days later, Goico says he has decided to introduce his bill as a standalone measure next session, rather than as an amendment. He says he believes the current version of Right to Try proposed in Kansas is too broad because it allows any medical provider with prescribing power to approve their patients’ access to drugs early in the FDA testing process.
He would like a bill that allows only those working at the University of Kansas Cancer Center to prescribe drugs that are well into clinical trials. That would provide more protection for patients like his wife, he says, who is going through her second bout with cancer.
“It seems to me that we need to protect the public,” Goico says. “By being in the last stage of testing, you already know it will work. You know there won’t be any negative consequences.”
— Andy Marso is a reporter for KHI News Service in Topeka, a partner in the Heartland Health Monitor team. You can reach him on Twitter @andymarso.
The Kansas Department for Children and Families announced major changes to its standards for substantiating child abuse last Tuesday. But lawmakers want more reform of a privatized foster care system they say is failing to protect children.
DCF Secretary Phyllis Gilmore announced that the agency will begin using a “preponderance of the evidence” as the standard for substantiating a child abuse claim rather than the more stringent “clear and convincing evidence.”
Gilmore noted that Kansas is the only state using the “clear and convincing evidence” standard. The change will make it easier for state investigators to place people suspected of child abuse on a registry that prohibits their employment at child care facilities.
The agency also added a category between unsubstantiated and substantiated — “affirmed” — that will describe cases in which abuse or neglect are believed to have happened but not to a level severe enough to bring a substantiated finding.
Prosecutors seeking to bring criminal abuse charges still will have to prove guilt beyond a “reasonable doubt,” and only judges can remove the custody rights of children’s legal guardians.
The changes were announced during a hearing of a special legislative committee formed to vet the state’s foster care system.
The Capital-Journal’s reporting focused on Mekhi Boone, a 4-year-old Hiawatha boy who was beaten to death after DCF and one of the state’s foster care contractors placed him with his father.
Kaddillak Poe-Jones, a Wichita infant who died in a hot car after the foster parents she was placed with forgot her, also was mentioned in Tuesday’s hearing.
Democrats pushed for an audit of the system in July, but it narrowly failed when five Republicans voted it down. At last Tuesday’s hearing, though, the majority party members expressed serious concerns as well.
The foster care system has been privatized since 1997, and DCF now works with two contractors, KVC Behavioral Healthcare of Olathe and St. Francis Community Services of Salina. A subcontractor, Topeka-based TFI, handled Kaddillak’s case, and DCF briefly halted new foster care placements with that agency after her death last year.
In recent years the state has consistently set records for the number of Kansas children in foster care, topping 6,000 last year. The state currently pays the contractors about $280 million annually.
— A. M.
Cerner Corp. is unhappy that the University of Missouri has given the former chancellor of its Columbia campus a supporting role in a partnership operated by MU and Cerner without Cerner’s prior knowledge or approval.
In a letter sent Nov. 12 to the chairman of MU’s governing board, Cerner’s corporate counsel, Amy Freeman Pierce, complained that Cerner was not consulted or notified in advance that R. Bowen Loftin would have a role with the Tiger Institute for Health Innovation.
The institute was formed by MU and Cerner in 2009 to digitize the university’s health system, introduce innovations in the delivery of health care, and reduce the sprawling university system’s health care costs. Earlier this year, the partnership was extended to 2025.
Cerner is a leading Kansas City-based health information technology company. It recently won a multi-billion contract from the U.S. Department of Defense to modernize the military’s electronic health records system.
Amid continuing racial unrest on the Columbia campus, Loftin on Nov. 9 announced he would resign as chancellor at the end of the year and instead take on a new position overseeing university research. Among other things, his written transition agreement calls for him to direct university research supporting the Tiger Institute.
Loftin’s resignation came the same day Tim Wolfe, the university system’s president, resigned. The university last week named Hank Foley as interim chancellor.
In her letter, which was first disclosed by The Columbia Missourian, Pierce wrote that “(d)ecisions regarding matters material to the Tiger Institute require consensus from the Tiger Institute Board of Governors, a body with equal representation from Cerner and the University.”
Upon learning of Loftin’s agreement with the university, Pierce wrote, Cerner “immediately requested the removal of all references to Cerner and the Tiger Institute from the transition term sheet, pending appropriate review by the Tiger Institute’s Board of Governors.”
MU spokesman John Fougere said last Tuesday that the transition agreement “certainly anticipated that Cerner’s viewpoints would be solicited, and we appreciate their providing those.”
“Terms of the transition agreement are subject to further discussion towards what would be a final, formal agreement,” he said.
Cerner spokesman Dan Smith said Tuesday that Loftin’s role with the Tiger Institute had not even been approved by the university’s governing board, let alone that of the institute, so the institute was in no position to approve it or disapprove it.
“Cerner’s understanding is that the terms of transition agreement that Dr. Loftin submitted to the board of curators hasn’t been considered by that body yet,” Smith said. “So the curators need to determine if those are acceptable terms to them first before this potential connection to the Tiger Institute comes to the (institute’s) board of governors.”
A statement released by Cerner said it was concerned “with the university’s decision to act unilaterally in speculatively including the possibility of a supporting role for Dr. Loftin within the Tiger Institute. This action does not comply with the governance structure for oversight of the Tiger Institute.”
— Dan Margolies, editor of the Heartland Health Monitor team, is based at KCUR. You can reach him on Twitter @DanMargolies.
Two Kansas lawmakers who lost their health committee assignments because they support Medicaid expansion say the purge has given the issue more momentum.
Interviewed over the weekend for KCUR’s “Statehouse Blend” podcast, Republican House members Susan Concannon, from Beloit, and Don Hill, from Emporia, said Speaker Ray Merrick’s decision to remove them from the Health and Human Services Committee was a mistake if his goal was to shut down discussion on the expansion issue.
“I think the leadership was shortsighted and ill-advised,” Hill said. “The response I’ve had from my constituents has been overwhelming. There is a sentiment that they’ve been deprived a voice.”
News of the purge broke just as Concannon, the vice chairwoman of the committee, was sending her annual pre-session survey to constituents.
“A day or two after the news hit, people were filling out the survey,” she said. “So, I am getting a lot of feedback right now and people are quite upset.”
Merrick, a conservative Republican from Stilwell, issued a statement confirming he ordered the shake-up because of his opposition to the Affordable Care Act and Medicaid expansion.
“Kansans oppose expanding Obamacare, a program that has busted budget after budget in states that have expanded it,” Merrick said. “I will continue to fight to protect Kansans from the disastrous effects of Obamacare.”
Merrick and other GOP leaders, including Gov. Sam Brownback, oppose expansion in part because they say it will provide coverage to non-disabled adults while Kansans with disabilities continue to wait for Medicaid support services that allow them to live independently.
The expansion issue has gained little traction in the Legislature despite a strong lobbying effort by Kansas hospitals. However, two recent events — the closure of a southeast Kansas hospital and a Wichita forum where Kansas lawmakers discussed a conservative expansion plan implemented by Republican Gov. Mike Pence in Indiana — were starting to generate more serious discussion of the issue, Concannon said. (For more on the forum, see next story)
The health committee purge, she said, was an attempt to blunt whatever progress expansion advocates were making and to warn House Republicans to stop “discussing these hare-brained ideas.”
Characterizing Merrick’s actions as “heavy handed,” Hill predicted they wouldn’t work. The financial struggles of other rural hospitals, growing support from religious and business groups, and polls that show that a majority of Kansans support expansion will at some point force lawmakers to deal with the issue, he said.
Brownback privatized the Kansas Medicaid program in 2013. Now called KanCare, the nearly $3 billion program is administered by three managed care organizations. Expansion would extend KanCare coverage to non-disabled, childless adults with incomes up to 138 percent of poverty, $16,105 annually for an individual and $32,913 for a family of four.
It is estimated that expansion initially would provide coverage to approximately 150,000 Kansas, many of whom are now uninsured because they make too much to be eligible for the state’s existing KanCare program but too little to qualify for federal tax subsidies to help them purchase private coverage in the ACA marketplace.
— Jim McLean is executive editor of KHI News Service in Topeka, a partner in the Heartland Health Monitor team.
Add the Wichita Metro Chamber of Commerce to the list of Kansas organizations that support expanding Medicaid to cover more low-income adults.
Pushed by influential hospital members Via Christi Health and Wesley Medical Center, the chamber’s board voted Thursday to add expansion to its list of policy priorities for the 2016 legislative session, said Jason Watkins, the organization’s lobbyist.
But, Watkins said, the chamber’s support is conditional. Expansion must be revenue neutral, meaning it cannot increase state spending. And it must require non-disabled adults to work or participate in job training to qualify for coverage, a condition that could make it a tough sell to federal officials.
“I want to be clear, if a program comes out and it costs the state $100 million a year, that’s not what we’re supporting,” he said.
About 70 percent of the members who responded to a survey used to formulate the chamber’s positions supported Medicaid expansion, Watkins said. However, 45 percent said their support was contingent on the plan being revenue neutral.
The chamber’s conditions mirror two of the three set by Gov. Sam Brownback. In addition to budget neutrality and a work requirement, the governor has said he won’t consider an expansion plan that doesn’t also extend Medicaid support services to thousands of Kansans with physical and developmental disabilities who are now on waiting lists.
Opposition from Brownback and Republican legislative leaders has prevented debate on expansion the past two legislative sessions. But the recent closure of Mercy Hospital in the southeast Kansas community of Independence has made some lawmakers open to considering a plan like those crafted by conservative Republican governors in other states.
The tension around the expansion issue is evident in another Wichita-based business organization. The Wichita Independent Business Association also surveyed its members, many of whom are small-business owners, on the issue. But Lon Smith, WIBA’s new president, was not eager to publicly discuss the results.
The survey question on expansion generated a higher than usual response from members, Smith said, although he declined to provide the results. However, others claiming to be familiar with the WIBA survey, who asked that their names not be used, said respondents favored expansion by a wide margin.
The Heartland Health Monitor is a reporting collaboration among KCUR, KCPT, KHI News Service and Kansas Public Radio focusing on health issues in Kansas and Missouri.