Opioid commission, with new member, will hold hearing Monday, July 17 on ibogaine, exotic drug proposed for drug treatment

By Melissa Patrick
Kentucky Health News

The Kentucky Opioid Abatement Advisory Commission will hold its first public hearing Monday, July 17, about the use of an exotic psychedelic drug, ibogaine, as a treatment for opioid-use disorder.  

The hearing follows the May 31 announcement at which Bryan Hubbard, the commission's chair and executive director, asked the commission to consider using $42 million of the more than $900 million in settlement funds being paid by drug companies to invest in clinical trials of the drug to win approval for its use. 

The public hearing will be held in the Administrative Office of the Courts building, 1001 Vandalay Drive, Conference Room A-125, Frankfort from 9 a.m. to 3:30 p.m. It will be live-streamed for those unable to attend. 

Hubbard told the commission at its July 11 meeting that the hearing will include an expert panel of researchers and clinicians who will provide insight into ibogaine therapy as a treatment for addiction. Hubbard told Kentucky Health News that all of panelists will speak in support of the treatment. 

The panelists listed in a press release are Dr. Kenneth Alper, associate professor of psychiatry and neurology at the New York University medical school; Dr. Deborah Mash, professor of neurology and molecular and cellular pharmacology and director of the Brain Endowment Bank at the University of Miami, and founder and CEO of DemeRx; Dr. Srinivas Rao, chief scientific officer at ATAI Life Sciences in Berlin; Dr. Douglas Kramer, senior vice president, pharmacovigilance and regulatory affairs, Athenex Inc.; and Dr. Nolan Williams, associate professor at Stanford University and director of the Stanford Brain Stimulation Lab.

The press release was issued by a public-relations firm that is being "retained by a private benefactor who is supportive of " the commission's efforts "who wishes to remain anonymous," said an email from Brad Burge, founder of the firm.

After opening remarks from each panelist, there will be a "round robin" question-and-answer session with the commissioners that will last four hours, Hubbard said. He said this process will allow for "a very open and vigorous and enlightening conversation about whether ibogaine is something that is worth considering or pursuing or not." 

He said at least two people will talk about their recovery experience with ibogaine treatment outside the U.S., which has not approved the drug for any use. He told Kentucky Health News that the public would be allowed to ask questions for about 30 minutes at the end of the meeting. 

The second public hearing on ibogaine has been rescheduled to Sept. 15 from 9 a.m. to 3:30 p.m. at the Administrative Office of the Courts, 1001 Vandalay Drive, Conference Room A 125, Frankfort.  

New commissioner appointed

Since the June meeting, University of Kentucky President Eli Capilouto named Patricia Freeman, a pharmacy professor whose research focuses on substance-use policy and the prevention and treatment of substance-use disorders, as the university's new HEALing Communities Study representative on the commission.

Patricia Freeman

Freeman replaces Sharon Walsh, principal investigator of the $87 million National Institutes of Health-funded study, which is aimed at finding tools for preventing and treating opioid addiction.

Walsh told Kentucky Health News that she was leaving the appointment due to additional and ongoing work responsibilities. She wrote in an email:

"We were informed a few weeks ago by the federal government that the HEALing Communities Study (which I lead) is being extended once again by the NIH (it was originally a 4-year project and is now going to be a 6-year project). Between that, other new NIH projects, and my leadership responsibilities at the university, I needed to reduce some of my extra external activities. Of Freeman's appointment, she said, "She is very knowledgeable and I know she will do a great job."

At the June meeting, Walsh questioned the idea of using opioid-settlement money to do clinical trials of ibogaine and pointed out that Mash, whom she knows, is the founder and CEO of a pharmaceutical company developing ibogaine for treating addiction, which presents a "clear conflict of interest."  She also pointed out that there are already drugs available for opioid withdrawal if that is the main goal of these trials. 

Hubbard told Walsh at the meeting that she could invite an expert of her choosing, but as of July 11, he told Kentucky Health News that he had not received any suggestions. 

Asked if her opposition to ibogaine had anything to do with her leaving the commission, Hubbard said as far as he was concerned, it didn't. "I don't have any issue with any commission member who takes a principal position of disagreement," he said.  

Application portal to close and reopen

The application portal to apply for an opioid settlement grant will close Aug. 30, 2023 for maintenance and will re-open on Jan. 1, 2024. Hubbard said because of this, any grants that are in process and those who want to complete their application need to have that done by Aug. 30. He added that more information will be forthcoming on the website. 

Frankfort power struggle, too few dentists and low Medicaid pay are all barriers to healing the pain in poor Kentuckians' mouths

Dr. Bill Collins treats a patient at the Red Bird Mission
dental clinic in Clay County. (Photo by Deborah Yetter)

By Deborah Yetter
Kentucky Lantern

RED BIRD, Ky. — At the Red Bird Mission dental clinic in southeastern Kentucky, patients with few or no teeth now are eligible for dentures through an expansion of the state’s Medicaid dental services for adults.

“People are tickled to death,” said Dr. Bill Collins, the dentist at the United Methodist Church mission in a remote corner of Clay County. “We get patients who haven’t had teeth for 20 years.”

Dentures and other services newly covered by Medicaid have the potential to remake Kentucky’s image as a state of “toothless hillbillies,” said Collins, who has treated patients in the region for decades. “I hate that image.”

But a political fight in Frankfort over who has the power to enact the new benefits — that also expand vision and hearing services — could end the extra coverage advocates say is desperately needed.

Already the new benefits have started, stopped and started again amid a tussle between Republicans who control the General Assembly and Gov. Andy Beshear, a Democrat who enacted them Jan. 1.

Lawmakers have scheduled a hearing Thursday, July 13 on the new benefits, but already expressed their disapproval at a meeting in May, where Republicans who control the legislature said Beshear usurped their authority over Medicaid, the federal-state health plan for low-income people.

“I’m not necessarily opposed to doing this,” said Rep. Derek Lewis, R-London. “There’s a lot of people in my district that could benefit from this. But the process matters.”

His southeastern Kentucky district usn't the only one. The state ranks 49th in oral health and consistently ranks among the top states in the number of adults with no teeth.

“We really wish that the governor’s office and the legislature, working together, could find a way to get this done instead of being adversarial,” said Dr. Stephen Robertson, executive director of the Kentucky Dental Association.

Since lawmakers have the power to kill the expansion when they next meet in 2024, there’s no guarantee the benefits will last beyond this year.

Samone Gist, a Louisville woman suffering from multiple dental problems, says she just wishes someone would establish consistent, accessible dental care for people like her, who rely on Medicaid for health coverage.

A shortage of dentists — especially a lack of those who accept Medicaid, due to its notoriously low reimbursement rates — makes it difficult to find an appointment, health advocates say.

Recently, Gist said she managed to get one decayed tooth pulled but has others that need treatment. “I was in so much pain, it was unbelievable,” she said. “The pain is unbearable.”

Dental disease is linked to a host of health problems including infection, diabetes complications, heart disease and premature births — all significant health issues in Kentucky. It also is linked to addiction among those prescribed painkillers for dental abscess and decay, problems that too often send people to emergency rooms, advocates say.

Kentucky spends about $9 million a year in Medicaid funds on patients visiting the emergency room for dental pain, according to the Cabinet for Health and Family Services. In such cases, patients generally are prescribed antibiotics for infection and painkillers but don’t get dental care.

By contrast, the expansion of dental, vision and hearing benefits is expected to cost about $36.5 million a year, with $31 million covered by the federal government, which pays most of the state’s share of Medicaid. Beshear has said the state’s costs will be covered from savings in other areas in Medicaid.

Advocates argue that dental health, as well as good vision and hearing, also are essential in helping people get and keep jobs.

“Kentuckians need teeth. They need glasses. They need hearing aids,” said Cara Stewart, director of policy advocacy for Kentucky Voices for Health, a coalition of health groups. “It’s just a no-brainer.”

Gist, who recently attended a job-training program and is looking for work, agrees.

With bad teeth, “It’s embarrassing to do an interview or try to get a job,” she said. “It will definitely hold you back.”

There seems to be little dispute in Frankfort about the need for the expanded dental and other services for the 900,000 adults covered by Medicaid who could benefit.

But that’s where agreement ends.

‘We’re number one’

For decades, adults covered by Medicaid were eligible only for an annual cleaning and tooth extraction. In a poor state where nearly 1.7 million people get care through the federal-state health plan, that led to inevitable results, said Robertson, the dental association executive.

“When the only benefit you’ve got is to have a tooth removed, that’s what the outcome is going to be,” Robertson said, adding that a recent study ranked Kentucky first in the number of toothless, older adults: “We’re number one”

So last October, citing the need, Beshear announced he was using executive authority to expand Medicaid dental, hearing and vision benefits for adults in the program.

Adults can now get dentures, fillings, crowns, and two checkups a year — as well as eyeglasses and hearing aids.

Children enrolled in Medicaid, currently about 637,000, already are eligible for a full range of dental, vision and hearing services.

Republican lawmakers objected to Beshear's move, saying he should have sought legislative approval. They passed Senate Bill 65 to stop the new benefits. But after the legislature adjourned, Beshear issued a new set of emergency regulations to again provide the expanded dental, vision and hearing services.

That restored the benefits but set up a new confrontation with Republicans who hold a supermajority in the General Assembly.

'Groundhog Day'

GOP lawmakers were swift to react, taking up the new version of the benefits at the May 9 meeting of the joint Administrative Regulations Review Subcommittee. They complained the new version looked much like the old version they had already rejected.

“I half expected Bill Murray to come to the table today because I feel like this is ‘Groundhog Day’,” said Senate Majority Floor Leader Damon Thayer, referring to the movie where Murray plays a TV news personality caught in a time loop. “The same thing kept happening over and over again.”

Beshear administration officials, including Medicaid Commissioner Lisa Lee, insisted the plan was within the bounds of a law that prohibits enacting regulations that have been rejected.

Besides, Lee said, with Kentucky’s abysmal ranking in oral health, it’s time to break out of the groundhog mode.

Since 2014, after Kentucky expanded access to Medicaid under the Affordable Care Act to include more low-income adults, the state has moved from 47th to 43rd in overall health rankings. “But we remain 49th in oral health care,” Lee said. “We have got to get something done here.”

Rep. Daniel Grossberg, a Louisville Democrat, agreed.

“Something has got to change,” he said. “We may be having an element of ‘Groundhog Day’ here but we’re living it over and over because neither side’s willing to give.”

Cabinet numbers show that the expanded benefits so far have resulted in dental, vision and hearing services for 196,000 people and about $12 million in payments to providers. About 4,000 adults have received dental services including 2,500 sets of dentures.

Republicans say they don’t necessarily dispute the need for those services, they fault the Beshear administration for failing to work with them.

“You kept coming back after we said no,” said Rep. Randy Bridges of Paducah. “We said no. We said no. You don’t want no. You’re going to do what you dang well please.”

Lewis, co-chair of the committee, said benefits aren't the point. “I think every single person on this committee would be in favor of expanded dental services,” he said. “But our job on this committee is to protect the legislative process.”

The committee voted 5-2 to find the regulations “deficient,” with Democrats casting the two no votes, but the legislature can’t actually block them until it meets again in session in 2024 and enacts legislation to do so.

‘Last bastion of small business’

Meanwhile, Kentucky needs to work on other problems plaguing dental services throughout the state, especially in rural areas, dental officials said.

Medicaid reimbursement rates for dental services have not increased for 30 years to the point where costs of dental care exceed what the program pays, Robertson said: “For an office to decide to participate in Medicaid, they have to agree to operate at a loss.” 

Of the state’s 3,200 licensed dentists, about 57% are signed up to treat Medicaid patients, but many either don’t accept them or limit those they see because of low reimbursement, he said.

The Medicaid reimbursement of $656 for dentures doesn’t cover the Red Bird clinic’s base cost of $1,100, meaning the nonprofit clinic has to make up the difference from other sources, Collins said.

“People tend to forget dentists are the last bastion of small business in Kentucky,” Robertson said. “When you are asked to operate at a loss, that’s not a sound business plan.”

The state’s latest proposed regulations include increased reimbursements for dentists.

The state also doesn’t have enough dentists and other staff, such as dental hygienists, to meet demand.

Even federally qualifed community clinics, long considered the medical safety net, have extended waits for dental care and few openings for patients, said Melissa Mather, chief communications officer for Family Health Centers in Louisville.

Collins, the Red Bird Mission dentist, agrees all those problems must be addressed. But he said another concern is whether the legislature will even allow the expanded benefits to survive.

“I am for this Medicaid expansion big-time,” he said. “But when Jan. 1 hits, they’re going to come in here and stop it.”

Robertson thinks all these problems have solutions, but it’s going to take a concerted effort in a state that ranks 49th in oral health and first in the rate of older adults with no teeth.

When it comes to overall health, “The mouth is the gateway to everything,” he said. “We’re for finding the best way to move forward.”

UK gets another 5-year grant to study major environmental health impacts on Kentuckians, keeping focus on Appalachian Kentucky

UK press release

The University of Kentucky Center for Appalachian Research in Environmental Sciences will continue its work to study major environmental health impacts on Kentuckians with a renewed award from the National Institute of Environmental Health Sciences, part of the National Institutes of Health.

The $7.4 million grant will run for the next five years. UK-CARES was established in August 2017, with an initial $7.4 million NIEHS grant, making it an Environmental Health Sciences Core Center to enhance research across all spectrums — basic, clinical, epidemiological, and translational.

UK-CARES is focused on studying environmental health effects of air and water quality that are implicated in environmentally induced disease, as well as emerging threats such as flooding and exposure to new contaminants.

Ellen J. Hahn

“Over these last five years, our commonwealth has been through one major event after another, from the Covid-19 pandemic to historic flooding and devastating tornadoes,” said Ellen J. Hahn, professor in the UK colleges of Nursing and Public Health, and director of UK-CARES. “The members of UK-CARES along with our community partners have done critical research to understand and address environmental health impactsWe will continue to learn with and from the community to tackle the environmental challenges facing the state and the health of its people, especially throughout Appalachia.”

The center provides pilot project funding, research expertise, career development, a faculty fellows program in science communication, mentorship, and community grants to facilitate innovative discovery and new understandings of environmental factors in disease initiation, progression and outcomes and their community impacts. You can learn more about those efforts here.

“The research conducted within UK-CARES is a tangible fulfillment of the University of Kentucky’s mission to serve the commonwealth, specifically the people who face the highest rates of chronic diseases and the regions that face tremendous environmental challenges,” said Lisa Cassis, UK vice president for research. “The renewal of this award will allow investigators across our institution and stakeholders in the community to continue to partner to find solutions to these pressing environmental health issues in Appalachian Kentucky and beyond.”

UK-CARES is housed in the College of Nursing, along with BREATHE (Bridging Research Efforts and Advocacy Toward Healthier Environments), which Hahn also runs. The center has an interdisciplinary team of researchers across the colleges of Medicine, Nursing, Public Health and Engineering, as well as the Gill Heart Institute, Kentucky Water Research Institute, Markey Cancer Center, the UK Center for Excellence in Rural Health and Kentucky Homeplace, and the USA Drone Port in Hazard.

The center offers different types of memberships for those interested in contributing to the breadth of environmental health research at the center. You can find more information here.

It's time to make sure your children are up to date on vaccinations required for school; Kentucky lags behind all the states it borders

State Dept. for Public Health graphic

By Melissa Patrick
Kentucky Health News

With just a few weeks left before school starts, it's time to make sure your school-aged children are up to date on their required immunizations. It's especially important because Kentucky's children fell behind on their immunizations during the pandemic, and many of them still haven't caught up. 

"Kentucky is really low on a lot of childhood vaccines . . . and when that happens . . . when people are not vaccinated, especially children with developing immune systems, that can cause these diseases to run rampant," said Ryan Babb, manager of the University of Kentucky's retail pharmacy services.

At a recent Immunization Summit hosted by the Immunize Kentucky Coalition, State Epidemiologist Kathleen Winter said Kentucky is behind all of its bordering states in routine childhood vaccination rates and is well below the national average. 

Winter said the greatest concern right now is among kindergarteners, because their measles-mumps-rubella vaccination rate has dropped in the last two school years. 

She also noted that since 2018, fewer Kentucky children have received the DTap or Tdap vaccine against tetanus, diphtheria and pertussis (whooping cough), and this is especially true among seventh-graders. 

Also, she said only 57% of Kentucky teens have taken the human papillomavirus (HPV) vaccine that protects against more than 90% of cancers caused by it. 

Babb encouraged Kentucky parents to get their children vaccinated at their local pharmacy, noting that while all Kentucky pharmacists can offer vaccinations to children between the ages of 9 and 17, some have a  "collaborative care agreement with a pediatrician," like UK's pharmacies do, that allows them to offer them to children as young as 6 months.

"We feel like it's really important to increase access, it's much easier than to . . . walk in and get a vaccination rather than having to schedule an appointment with a provider," Babb said. 

And if your child has gotten behind on their routine vaccination schedule, there are catch-up schedules to get them up-to-date. "You can always catch up," he said. 

Babb said it's also important to remember that immunizations provide "herd immunity," which occurs when enough people have been immunized against disease to protect others who are not immunized. Some can't get vaccinations because their immune systems are too weak to allow them to get shots, or because they are too young.

Children can also get their routine vaccinations at health clinics, health departments and doctor's offices, but it's important to make those appointments soon because school typically starts in August and students are required to provide up-to-date immunization records at the beginning of each school year, unless exempted for religious or medical reasons. 

Babb cautioned people who are hesitant about vaccines to make sure they are listening to reliable sources on the subject because there is a lot of vaccine misinformation out there. 

"My recommendation to anybody is before you do a Google search or before you start checking any other social media or getting opinions based on that, just call your local pharmacist [or] . . . even a primary care provider . . .  to get the right information the first time before digging down a rabbit hole of misinformation," he said. 

Ruth Carrico, a senior research scientist with Norton Infectious Diseases Institute, talked at the summit about ways to combat vaccine hesitancy. She placed the bulk of that responsibility on health-care providers and their employees. 

"You need to be all in," she siad. "And then be honest, unashamed, and unafraid of your position. It doesn't mean that you're sanctimonious, and you're high and mighty, and you don't listen to others. .  . But the idea is, if you are all in for immunization, then that needs to be where we are heading and that needs to be the basis for our interactions as we move forward."

Further, she said health-care professionals must have a firm understanding and expertise of how vaccination and the immune system work to answer people's questions in a "truthful, credible and sustainable" way. 

"Our time to understand vaccines and promote vaccine confidence is now," she said. "We need to remember very clearly, lest we get influenced by misinformation and pushback in social media, that vaccines save lives."

Covid-19 vaccine mandate for health-care workers ended in mid-June, but some major Kentucky hospitals still have such policies

By Melissa Patrick
Kentucky Health News

About a month ago, the Centers for Medicare and Medicaid Services withdrew its requirement that health-care workers get a Covid-19 vaccination, and while the final rule won't be official until on or about Aug. 5, CMS has said it does not intend to enforce staff vaccination requirements before that date.

Kentucky Health News checked with a few of the larger hospital systems in Kentucky to see if they had changed their policy and found that a few of them had, but others are still considering it. 

Maggie Roetker, Norton Healthcare's director of public relations, told the Louisville Courier Journal in mid-June that the hospital system had ended its Covid-19 vaccination policy for all employees, effective immediately. 

Roetker said the update on vaccine mandates goes along with new regulations enacted by accrediting agency DNV along with CMS and its parent agency, the Department of Health and Human Services.

"While Covid-19 vaccination is no longer a requirement for employees, volunteers, vendors and contractors, we do still recommend it to reduce the risk and protect each other and our patients," she told the CJ. "The vaccine is also recommended for people who are at risk of medical complications due to the virus.

Appalachian Regional Healthcare, which has 14 hospitals in Kentucky and West VIrginia, said it has changed its policy. 

"As of July 3, the Appalachian Regional Healthcare system is no longer mandating that employees at any of our locations in eastern Kentucky or southern West Virginia be vaccinated for Covid-19. While not mandated, the vaccine is still available for all employees who want to receive it," Melissa Cornett, assistant vice president of corporate communications for ARH, said in an email. 

However, UK HealthCare, Baptist Health and CHI Saint Joseph Health still have their Covid-19 vaccine mandates in place. 

“UK HealthCare has reviewed the changes in the Covid vaccine federal requirements and is currently determining the impacts to our workforce and determining next steps," Kristi Willett, executive director, public relations and strategic communications for the University of Kentucky, said in an email. 

Rebecca Brown, associate vice president of marketing for Baptist Health, said in an email, "Baptist Health still has its Covid-19 vaccination requirement in place. We are aware of the federal changes. Our clinicians are still reviewing and working through the reporting requirements for CMS. As we address those requirements, we will make a determination on any policy changes."

Mary Branham, market director for marketing and communications at CHI Saint Joseph Health said in an email, " We require a number of vaccinations, including the Covid-19 and flu vaccinations, to ensure the safety of each other and for those who rely on us for safe care, often when they are most vulnerable. This is imperative to our mission as a faith-based Catholic ministry. We continue to provide a process for religious and medical exemptions for those who qualify." 

Update, July 10, 2023: This story has been updated to include comments from CHI Saint Joseph Health about their current Covid-19 vaccination policy. 

Feds propose rules to limit ‘junk’ health plans to 4 months, keep them from 'gaming the system'; seek info on health credit cards

By Jennifer Shutt
States Newsroom

The Biden administration announced new initiatives Friday that could reduce health-care costs, though none will take effect immediately.

The changes include a proposed rule that would reduce the amount of time short-term health-insurance plans can last, and requirethe plans to be more transparent about what is covered and what isn’t.

Also, the White House is seeking information about high-interest-rate credit cards that doctors’ offices offer to help people pay for their care, and telling hospitals that patients are either in-network, with billing limitations in the Affordable Care Act, or out-of-network, with costs covered by a more recent law, the No Surprises Act.

White House Domestic Policy Advisor Neera Tanden told reporters Thursday that the proposed rule, which could be finalized later this year, would help Americans to understand the difference between health insurance offered under the Affordable Care Act and what she called “junk insurance.”

Those short-term plans, Tanden said, “are intended to provide temporary coverage as people transition from one source of coverage to another, like when we’re between jobs,” but during the Trump administration, the plans were allowed to last as long as three years, she said.

Tanden said the short-term plans have left some people with thousands of dollars in medical debt, including a Montana man who had $43,000 in medical bills after a short-term plan denied him cancer coverage by saying it was a pre-existing condition.

The proposed rule would limit short-term plans to three months with a one-month renewal option, and “require plans that discriminate based on pre-existing conditions and don’t offer comprehensive benefits to disclose their limits clearly to consumers,” Tanden said.

Unexpected medical bills

On surprise medical billing, the Department of Health and Human Services is sending guidance to hospitals that Biden administration officials hope will reduce or eliminate people receiving thousands in medical bills they did not expect.

“We’re making it clear that plans and providers cannot evade surprise billing rules simply by changing the terms they use in their contracts,” Tanden said. “Some health plans contract with hospitals, then try to claim that they are not technically ‘in network.’ Frankly, what they are doing is gaming the system. This is not allowed and, as our guidance will describe, it must end.”

A senior administration official, speaking on background to describe details of the guidance, said it should clarify that there is no space between the protections for out-of-network costs covered under the federal law known as the No Surprises Act, or protections in the Affordable Care Act for in-network costs.

“We are saying there is no gray area here,” the official said. “It is either the protections of the No Surprises Act, or the protections for out-of-pocket costs.”

The other initiative from the administration unveiled Friday requests information from the public about credit cards and certain types of loans that are often offered to people to help them pay for health care.

Tanden said people signing up for such cards may not understand how they work because they “often include teaser rates and deferred interest features that lead to higher costs for consumers.”

A second senior official, also speaking on background, said the cards often have interest rates that are much higher than a regular card. They are sometimes offered to patients in a health-care provider’s office.

First drug to slow Alzheimer's disease gets full FDA and Medicare approval for early-stage cases; drug is still in clinical trials at UK

Dr. Jim Jackson of Morehead receives a lecanemab infusion
at UK's Sanders-Brown Center on Aging. (UK file photo) 

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration has granted full approval for the first drug to slow down the progression of Alzheimer's disease, opening the door for Medicare to pay for it.

"This is the first medicine ever that actually changes the disease in the brain, removes a component of the disease and can extend quality of life for patients who are developing and who are in the early stages of Alzheimer’s disease," Dr. Greg Jicha, director of clinical trials at the University of Kentucky Sanders-Brown Center on Aging, said at a news conference on Friday. 

Jicha stressed that the drug is not a cure, but instead has been shown in clinical trials to slow the disease process by 27% to 40%. 

Lecanemab, marketed by Japanese drug maker Eisai and U.S. partner Biogen under the brand Leqembi, is an antibody that targets amyloid plaques, which are found in brains of people with Alzheimer's. It is administered twice a month, intravenously; the firms have estimated treatment will cost $26,500 a year. 

The drug has been on the market since January 2023 under an accelerated approval from the FDA but was not broadly covered by Medicare. Following the FDA's full approval of the drug, Medicare, which primarily serves adults age 65 and older, will now cover it for those who qualify. 

With the Centers for Medicare and Medicaid Services' announcement, Jicha said the approval would make coverage more likely by other insurers, including Medicaid, which is a federal-state program.

Jicha also said he hopes Esail will have patient-assistance programs to ensure that anyone who qualifies for the drug has access to it. 

“I really think it behooves all of us to ensure that this medicine is accessible to everybody,” he said. “No matter what their socioeconomic status, no matter what their geographic limitations are, everyone who has early Alzheimer’s disease deserves the opportunity as long as the medicine is going to be safe for them.”

Dr. Jim Jackson, a retired pediatrician from Morehead, participated in an 18-month lecanemab study at UK and is now part of what his wife, Sharon, called an "extension study." 

"I felt that it was really a good opportunity to be part of something that can improve life for many, many people," he said at the news conference. Later adding, "I would be very happy to recommend this drug. I've been tickled to death to be in the study." 

Jicha said there are some side effects to the drug, including amyloid-relating imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolve over time. He said people with two copies of a well-known Alzheimer's risk gene may be more at risk of ARIA. 

Sharon Jackson said her husband has responded well to the drug and has had no side effects. When he started the clinical trial, she said, "Jim had a little bit of memory issues and I can plausibly say that it has not progressed very much. . . . I can see that this medication, from what I understand about Alzheimer's, seems to be holding him pretty steady."

Who qualifies for the drug?

The medication will only be available to those in the early stages of the disease, and doctors willhave to verify that there is a buildup of amyloid in the brain before they can prescribe, Jicha said. Also, he said the drug must be administered by specialists who understand how to provide the treatment and to monitor for safety. 

“This medicine is only for those with mild memory problems, what we call mild cognitive impairment or folks that are in the mild stage of Alzheimer’s,” Jicha said, because benefits are uncertain for those in “a more moderate or severe stage.”

The drug is not available to people at risk of Alzheimer's, but Jicha said ongoing clinical trials are evaluating the usefulness of the drug for this group.   

The Alzheimer's Association promoted early detection and diagnosis in its press release celebrating the full approval of lecanemab. 

"With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible. If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis and to discuss treatment options," says the release. 

In Kentucky, 75,000 people 65 and older are living with Alzheimer's and that number is expected to increase by 15% in the next few years, to 86,000 in 2025, according to the Alzheimer's Association. Further, the association says 11.2% of people aged 45 and older have subjective cognitive decline.

Some people have misgivings. "Providers and health researchers who have doubts about the drug’s safety and efficacy say the decision exemplifies broader problems with FDA’s approval process," Jessica Karins of Inside Health Policy reports. "The critics raise concerns with the safety profile of the early-stage Alzheimer’s treatment . . . and say the difficulty of measuring cognitive decline means it remains unclear how much the drug can slow the progression of Alzheimer’s disease."

Five cases of Legionnaires' disease reported in Lexington, prompting health officials to urge caution around pools, hot tubs

Centers for Disease Control and Prevention graphic

By Melissa Patrick

Kentucky Health News

The Lexington-Fayette County Health Department announced Thursday that it has seen an increase in Legionnaires' disease this year and is warning people to take caution around outdoor pools and hot tubs, since the disease is spread when people breathe in small droplets of water that contain the bacteria that causes it. 

"The increase of use of outdoor pools and hot tubs during the summer, combined with recent rainfall and the potential for stagnant water, creates a need for reminders about Legionnaires’ disease," the department said in a news release. 

Kevin Hall, spokesperson for the department, told Kentucky Health News that five cases of the disease have been reported and that they typically don't have any. He added that they were still investigating the sources of the infections and that it is still unknown whether the cases ae related. 

Legionnaires' disease is a very serious type of pneumonia caused by Legionella pneumophil bacteria. The bacteria can also cause a less serious illness called Pontiac fever.

"Legionella occurs naturally in freshwater environments, like lakes and streams. It can become a health concern when it grows and spreads in human-made building water systems," the release says. 

For example, the Centers for Disease Control and Prevention says it can grow in shower heads and sink faucets, cooling towers, hot tubs, decorative fountains and water features, hot-water tanks and heaters and large, complex plumbing systems like those found in hospitals, hotels and cruise ships. (It was discoveerd after an outbreak at a Philadelphia hotel durign an American Legion convention.)

The health department adds that swimming pools become a concern when the temperature sits within the danger zone for the growth of the bacteria: "Legionella are unlikely to grow in typical swimming pools because water temperatures are usually too cold. However, you should sample pools if they are associated with a possible exposure or temperatures are within the permissive range (i77 to 113°F )." 

Health officials say the disease is generally not spread from person to person, but that is possible under rare circumstances. 

People at higher risk of getting Legionnaires' disease are those 50 and older, those with chronic lung disease, current or former smokers, those who take drugs that suppress their immune system, and people with cancer or underlying illnesses like diabetes, kidney failure or liver failure. 

The CDC urges people to talk to their doctor or local health department right away if they think they have been exposed to Legionella or if you develop pneumonia symptoms, such as fever, cough, chills or muscle aches. And, to be sure to mention if you have spent any nights away from home in the last 14 days. 

The health department says public-health agencies reported nearly 10,000 cases of Legionnaires’ disease in the U.S. in 2018, but thie actual number was likely much higher because the disease often goes undiagnosed: "A recent study estimated that the true number of Legionnaires’ disease cases may be 1.8–2.7 times higher than what is reported."

In Kentucky, 606 cases of  Legionnaires' disease (both confirmed and probable) have been reported since 2018, with an average of 114 cases a year between 2018 and 2021. In 2022, the state reported 107 cases, which are still being reconciled, and so far, 43 cases have been reported in 2023.  

While the disease is uncommon and most people make a full recovery, it can be deadly. According to the CDC, most people who get Legionnaires' disease need  hospital care, and about one out of every 10 people who get the disease die from complications of the illness.

Take care of your teeth, help your mind: Study finds keeping teeth with severe gum disease is associated with atrophy of the brain

Taking care of your teeth could also mean taking care of your brain. A study published today says gum disease and tooth loss are linked to shrinkage in the hippocampus, a part of the brain that "plays a role in memory and Alzheimer’s disease. The study does not prove that gum disease or tooth loss causes Alzheimer’s disease; it only shows an association," says the American Academy of Neurology, which published the study in its journal, Neurology.

“Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” said study author Satoshi Yamaguchi of Tohoku University in Sendai, Japan. “Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason to take better care of their teeth.”

The researchers studied 172 people with an average age of 67 who reported no memory problems at the beginning of the study, when they had dental examinations, memory tests and brain scans to measure volume of the hippocampus. Another scan was done four years later.

"After adjusting for age, researchers found that for people with mild gum disease, the increase in the rate of brain shrinkage due to one less tooth was equivalent to nearly one year of brain aging," the AAN reports. "Conversely, for people with severe gum disease the increase in brain shrinkage due to one more tooth was equivalent to 1.3 years of brain aging."

Yamaguchi said, “These results highlight the importance of preserving the health of the teeth and not just retaining the teeth. The findings suggest that retaining teeth with severe gum disease is associated with brain atrophy. Controlling the progression of gum disease through regular dental visits is crucial, and teeth with severe gum disease may need to be extracted and replaced with appropriate prosthetic devices.”

DEA administrator says Congress needs to pass laws to keep social media from serving as platforms to promote, sell fentanyl

Centers for Disease Control and Prevention graph shows huge increase in fentanyl deaths.

The U.S. needs laws to force social-media companies to keep their platforms from being used to promote and sell fentanyl, DEA Administrator Anne Milgram said on NBC's “Meet The Press” Sunday, in a program that was devoted entirely to the drug and the problems it is causing. Just over half of teh 2,135 drug overdoses in Kentucky last year involved fentanyl, a very powerful opioid.

“The border’s an important part of this conversation because most of the fentanyl that we see coming into the United States is coming in through the southwest border,” Milgram said, but “Social media is also a vital part of the conversation. It is what I call the last mile. Because what the cartels need – they’re selling the deadliest poison we’ve ever seen – they need that to … be able to expand and sell more, they need to be able to reach people at massive rates. And that’s what social media’s doing,” The Daily Wire reports.

Host Chuck Todd asked Milgram asked if social-media companies were cooperating with federal law enforcement in trying to fix the problem. She said, “We have not, until recently, gotten nearly as much cooperation as we need. . . . The deputy attorney general convened all of us in April of this year and made it very clear, number one, that the companies have to comply with their own terms of service, which say, ‘This is illegal. You cannot be selling fake pills. You cannot be selling drugs on social media websites’.”

Milgam also said law enforcement needs to be able to get information from social-media companies. Asked if there was something the DEA does not have that Congress could give them that would help them address the issue, she said, “So we talk a lot with Congress about social media. We talk a lot about the need for these platforms – essentially, one of the main ways we see Americans dying right now is through social media, the purchase of pills, fake pills on social media. So, again, if we’re after, how do we stop 110,000 Americans from dying?” She said Congress was “a place to start.”

Kentucky has 84 syringe-service programs in 65 counties; the pandemic slowed their growth, but two have opened this year

State Department for Public Health map, adapted by Kentucky Health News; click on it to enlarge.

By Melissa Patrick

Kentucky Health News

Kentucky has added two new syringe-service programs for intravenous drug users this year, bringing the total to 84 SSPs, in 65 of the state's 120 counties. Hart County opened its program in January and Estill County reopened its program in April.

SSPs are part of what health departments call “harm reduction programs,” which offer a host of strategies to minimize the negative physical and social impacts of drug use. They are also called syringe-exchange programs or needle exchanges, for the best-known element of the prorgams.

Estill County's program reopened after being shut down in 2020 because the Irvine City Council took away its approval, required by state law in a city where a program is based. The Estill County Health Department's program is now in a mobile clinic that goes to multiple locations in the east-central Kentucky county. 

Hart County is in south-central Kentucky, which is served by the Barren River District Health Department. Charity Crowe, a UK Healthcare health-education coordinator embedded in the department's harm-reduction program, told Kentucky Health News that adding more SSPs to decrease overdose deaths is one goal of the Barren River Initiative to Get Healthy Together (BRIGHT) Coalition.

Only three of the eight counties in the district have SSPs. Warren County opened its program in 2016, Barren County in 2018, and Hart County in January. 

Crowe said one of the first steps they took as they worked to get local approvals in Hart County was a survey of local jail inmates, asking f they would use an SSP if it was available. She said 63 inmates, or 64% of the survey respondents, said they would use it.  

"That kind of helped us with getting everything passed through the Board of Health, Fiscal Court and City Council," Crowe said. She praised the efforts of County Judge Executive Joe Choate: "He was a huge supporter of the program and us getting it started, so that helped get everything moving along a lot quicker."

Asked if she had any advice for people in the 55 Kentucky counties that still don't have an SSP, but want one, she said it's important to keep educating people about what they are and why they are important. 

"Just to try to educate people on why we do what we do," Crowe said. "There's so much stigma surrounding the things that we do with harm reduction. . . . We are trying to make our communities a safer place, not just for people that use drugs, but for our kids, our first responders, everybody." 

She also encouraged them to not give up. "Pretty much anywhere that you go, you will get a little bit of pushback," she said. "But in order for us to break that stigma, we just have to keep educating people."

Looking to other counties in the district, Crowe said they have held an educational meeting in Edmonson County and are working to have one in Logan County. She said Logan County's health board of health and Russellville City Council have approved an exchange, but the Fiscal Court has not.

Kentucky Health News graph from state data; click on it to enlarge.

The steady growth of SSPs in Kentucky took a heavy hit from the pandemic, with only eight counties opening a new SSP since 2020. The legislature authorized the programs in 2015.

Syringe-service programs not only exchange clean needles for dirty ones, to decrease the spread of blood-borne diseases like hepatitis C and HIV, but provide education on the safe use and distribution of wound-care kits and Naloxone, which blocks a drug overdose. Other services are infectious-disease screening, vaccinations, and linking people to housing, food access, insurance, medical care, substance-use treatment and behavioral-health services.

Crowe said the SSPs in Hart and Warren counties also use a peer-support specialist who has "been a phenomenal resource for our clients." 

On June 29, a new law kicked in that decriminalized fentanyl test strips in Kentucky, meaning they will no longer be considered drug paraphernalia in the state. Because of this, Kentucky's SSPs can offer them to their clients . Fentanyl was involved in 72.5% of the state's 2,135 overdose deaths in 2022. 

Fentanyl test strips are paper strips that can detect the presence of the powerful opioid in pills and other drugs within minutes. They are considered a low-cost method of helping prevent drug overdoses and reducing harm, according to the Centers for Drug Control and Prevention.

State's first detailed report on domestic-violence cases has a wealth of data on how courts and law enforcement handle them

The report's court data is by area development district, not by judge or county, but it has data on how individual law-enforcement agencies served emergency protective orders. (Map from report, adapted by KHN; to enlarge, click on it.)

Kentucky Health News

"Kentucky has long had a problem with domestic violence," the Lexington Herald-Leader reports. "A 2012 survey found that 45% of women and 35% of men" in the state have been victims of domestic violence, sexual violence or stalking, "according to a new report released Friday, marking the first time the commonwealth has ever tracked the data. Now the commonwealth will begin to dig into the details with a debut domestic-violence report that will set a baseline for police reports, protective orders issues, court cases and other information."

The 207-page report has a wealth of information about how domestic violence is handled by courts and law-enforcement agencies at regional and local levels. It covers the 14,199 charges and 8,867 arrests related to domestic violence in 2022, and the outome of the 19,986 petitions courts received for emergency protective orders in criminal and civil cases.

For example, it gives the average number of days that it takes individual law-enforcement agencies to serve EPOs on people accused of domestic violence or threats of violence, based on reports by the agencies. Statewide, the average is 2.22 days, but in many counties, especially in Appalachian Kentucky, service is much slower, perhaps putting potential victims at greater risk.

Law-enforcement agencies that averaged 10 days or more (excluding those with fewer than 10 EPOs served) to serve EPOs were: Adair County sheriff (12 days), Bell County sheriff (13), Breckinridge County sheriff (12), Calloway County sheriff (14), Corbin Police Department (19), Garrard County sheriff (15), Laurel County sheriff (10), Lawrence County sheriff (11), Martin County sheriff (11), McCreary County sheriff (15), Perry County sheriff (10), Rockcastle County sheriff (15), Spencer County sheriff (13), Wayne County sheriff (10), Whitley County sheriff (12), Williamsburg Police Department (10); and Wolfe County sheriff (13).

Agencies that averaged 7 days or more (excluding those with fewer than 10 EPOs served) were: Anderson County Sheriff's Department (8 days), Danville Police Department (8), Estill County sheriff (9), Fayette County sheriff (7), Franklin County sheriff (7), Grayson County sheriff (7), Harrison County sheriff (7), Jefferson County sheriff (7), Jessamine County sheriff (7), Knox County sheriff (9), Letcher County sherifff (7), Lincoln County sheriff (7), Marshall County sheriff (7), Pendleton County sheriff (8), Pulaski County sheriff (8), Russell County sheriff (7), and Todd County sheriff (9).

Data on how courts handle domestic violence is not given by judge, court or jurisdiction, but by the state's 15 area development districts.

It shows that judges in the Lincoln Trail ADD (Meade, Breckinridge, Grayson, Hardin, LaRue, Marion, Nelson and Washington counties) approved only 40 percent of the petitions for EPOs regarding domestic violence, and 31 percent of those for tempotrary interpersonal protective orders.

Judges in the Northern Kentucky ADD (Boone, Kenton, Campbell, Carroll, Gallatin, Owen, Grant and Pendleton counties) had the next lowest approval rates, 63 and 45 percent. The statewide averages, respectively, were 72 and 60 percent.

In divorce and other civil cases where domestic violence was alleged, judges in the Cumberland Valley ADD (Jackson, Rockcastle, Laurel, Clay, Knox, Whitley, Bell and Harlan counties) had the lowest approval rate, 16.9%. Lincoln Trail was second-lowest at 19.8%, just ahead of the Kentucky River ADD (Wolfe, Owsley, Lee, Breathitt, Leslie, Perry, Knott, and Letcher counties), at 19.9%.

In civil cases where other interpersonal violence was alleged, judges in the Gateway ADD (Bath, Montgomery, Menifee, Rowan and Morgan counties) had the lowest approval rate, 9.1%. The next lowest rate, 12 percent, was in the adjoining Fivco ADD (Boyd, Carter, Elliott, Greenup and Lawrence counties). It was 14.9% in the Cumberland Valley ADD.

Generally, judges in the Bluegrass, Purchase and Green River ADDs were the most likely to issue protective orders.

The report was required by a 2022 law sponsored by state Sen. Whitney Westerfield, a Republican from Christian County. "Before this report, domestic violence advocacy groups had used a newspaper clipping service to keep track of domestic violence homicides," the Herald-Leader reports.

Westerfield, chair of the Senate Judiciary Committee, learned of the lack of centralized reporting from Herald-Leader Opinion Editor Linda Blackford. “It’s just unacceptable,” he told her as the bill mved through the legislature. “We can’t make informed public policy decisions without good information.”