First naxolone shipment under settlement with drug maker arrives

Teva Pharmaceuticals' generic naloxone

Kentucky Health News

Nearly 8,000 doses of naloxone, which reverses the effects of drug overdose, were delivered to Kentucky this week as part of a settlement with Teva Pharmaceuticals, Attorney General Russell Coleman announced.

In October, Teva agreed to pay the state more than $71 million over 13 years, resolving allegations that the company’s marketing and promotional practices fueled the opioid-overdose crisis. In addition to the cash payments, Teva agreed to provide more than 23,000 units of naloxone.

The shipment, the first of four expected this year, went to facilities in Louisville, Florence, Ashland, Paducah and Frankfort. The Opioid Commission is partnering with the Cabinet for Health and Family Services as well as the Kentucky Pharmacists Association for distribution.

“Naloxone is a critical lifeline for Kentucky families struggling with addiction,” Coleman said in a news release. “Equipping first responders, health professionals and treatment providers with this all-important medication can help save lives for Kentuckians on the road to recovery.”

Half of all opoid-settlement funds go to local governments. The state's half is distribited by the Kentucky Opioid Abatement Advisory Commission is responsible for the distribution, part of the attorney general's office. On Tuesday, June 4,, the commission will award its next round of grants.

Kentuckians can find out how to get free naloxone near them at FindNaloxoneNowKY.org. Naloxone is also sold under the brand name Narcan by Emergent Solutions Inc.

High cost of new diabetes drugs, more popular in Ky. than any other state, deprives low-income people of effective treatment

Photo by George Frey, Bloomberg, via iStock/Getty Images, KFF Health News

Editor's note: At the end of 2023 Kentucky led the nation in the percentage of state population, 2.1%, who had received the new class of diabetes and weight-loss drugs.

By Renuka Rayasam
KFF Health News

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill prescriptions for medications they need to control their blood sugar.

Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The couple’s doctor has tried prescribing similar drugs, which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production, but those are also often out of stock. Even if they are available, their Affordable Care Act insurance burdens the couple with a lengthy approval process or an out-of-pocket cost they can’t afford.

“It’s like, I’m having to jump through hoops to live,” said Cooper Harris, 46, a resident of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to KFF poll results released this month. Patients with the lowest disposable incomes who are hit the hardest; they have few resources and often struggle to see doctors and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month’s supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month’s supply of different GLP-1 drugs range from $936 to $1,349 before insurance coverage, according to the Peterson-KFF Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs — Ozempic, Rybelsus, and Mounjaro — reached $5.7 billion in 2022, up from $57 million in 2018, according to research by KFF.

The “outrageously high” price has “the potential to bankrupt Medicare, Medicaid, and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, told Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They’re kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont Healthcare in Conyers, Georgia. Many of Rahman’s patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that help patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers’ requirements that patients receive prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman’s patients see her, their diabetes has gone unmanaged for years and they’re suffering from severe complications like foot wounds or blindness. “And that’s the end of the road,” Rahman said. “I have to pick something else that’s more affordable and isn’t as good for them.”

GLP-1 agonists — the category of drugs that includes Ozempic, Trulicity, and Mounjaro — were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs’ benefits become apparent.

In March, the FDA approved the weight-loss drug Wegovy, a version of Ozempic, to treat heart problems, which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company J.P. Morgan estimated.

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs’ popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines’ ability to help with weight loss.

It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it’s kind of not as many people as you think,” she said. “There just isn’t any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. State Medicaid plans vary in their coverage of the drugs for weight loss. (Kentucky's does not.) Medicare won’t cover the drugs if they are prescribed for obesity. And commercial insurers are tightening access due to the drugs’ cost.

Health-care providers cobble together care plans based on what’s available and what patients can afford. For example, Cooper Harris’s insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, Texas, had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher-retirement health plan with a high deductible, couldn’t afford to be on a GLP-1 agonist, Addison said.

“Until she reaches that deductible, that’s just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn’t have the same benefits. “Those patients who have a fixed income are going to be our more vulnerable patients.”

Database lists opioid-settlement payments to local governments

Screenshot of first page of KFF Health News database of settlement
payments in Kentucky through March 4 shows the top 15 recipients.

How much money are your local governments getting from the settlements of lawsuits filed against opioid manufacturers and distributors? You can track it with a new online database from KFF Health News.

Kentucky is getting $478 million from the settlements through 2038, and a like amount is being paid each year to local governments in the state. State government got $100.7 million in 2022 and $17.4 million in 2023. It will get $21.8 million this year and the same amount in 2025, and an average of $24 million a year after that.

The state's money is being allocated by the Kentucky Opioid Abatement Advisory Commission, operated out of the attorney general's office. Local governments' spending is up to their governing bodies.

"This database undercounts the amount of opioid settlement money most places have received and will receive," note Aneri Pattani and Lydia Zuraw and Holly K. Hacker of KFF Health News.

The database reflects only the largest settlement so far, $26 billion to be paid by pharmaceutical distributors AmerisourceBergen (now called Cencora), Cardinal Health, and McKesson, as well as opioid manufacturer Janssen (now known as Johnson & Johnson Innovative Medicine).

It does not include settlements with other drug manufacturers and retailers Walmart, Walgreens, and CVS. Data from these five companies will be added in July, according to BrownGreer, the settlement firm that gets the money and makes the payments. It is not handling some additional settlements such as the agreement between Kentucky and four Midwestern states with regional supermarket chain Meijer.

Other settlements, including with OxyContin manufacturer Purdue Pharma, are pending.

Anthem is among health insurers now covering anti-obesity drug if it is prescribed to reduce the risk of heart attack and stroke

One of Kentucky's major health insurers is among the first that have "agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions," The Wall Street Journal reports. Kentucky has the highest share (about 2.1%) of a state's population that have prescriptions for the new class of weight-loss drugs.

Elevance Health, the corporate parent of Anthem, joined CVS Health and Kaiser Permanente in covering Wegovy to reduce the risk of heart attacks and strokes in beneficiaries "who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan," report the Journal's Peter Loftus and Anna Wilde Mathews.

State table shows Medicaid coverage numbers for March. FFS
means "fee for service," which is separate from managed care.

"Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan" and would make the change in the next few weeks. "A committee of outside advisers to Elevance Health’s CarelonRx unit, which manages pharmacy benefits, has approved the use of Wegovy to reduce the risk of major cardiovascular events. . . . The company also is working with state-government agencies to determine Medicaid coverage of Wegovy." Anthem manages the Medicaid care of about 172,000 Kentuckians; county-level numbers are available.

"The insurers’ moves open up reimbursement of the coveted but costly class of weight-loss drugs, which had previously been excluded from Medicare coverage by a U.S. law and which many private health plans had resisted reimbursing because of the expense," the Journal notes. "The decisions will ease the financial burden on people who had been paying more than $1,000 out of pocket each month because their health plan wouldn’t cover the medicines, and spur use among people who couldn’t afford the heavy cost or didn’t want to pay for it. Other Medicare and commercial health plans might now feel pressure to follow suit and begin coverage. But the widening coverage could result in billions of dollars in additional drug spending by health insurers that have struggled to keep a lid on rising health costs. Wegovy lists for about $1,349 a month."

U.S. Sen. Bernie Sanders (I-Vt.), chair of the Senate's health committee, this week called on insurers to charge Americans no more than they charge in Canada for the drugs. That would lower their prices by about two-thirds.

"The insurers’ decisions arose from new guidance issued last week by the Centers for Medicare and Medicaid Services," the Journal notes. Medicare Part D plans, "which are administered by private insurers, might cover anti-obesity medications if the drugs receive approval for an additional use. Their use for weight-loss alone would still be excluded from coverage. That new guidance applies to Wegovy because the Food and Drug Administration this month approved the weight-loss drug’s use reducing the risk of heart attacks and strokes in people with a history of heart disease, and who have a body-mass index above certain thresholds. A study showed Wegovy reduced cardiovascular risk by about 20% versus a placebo."

Kentucky-based Humana, which manages the care of 155,000 Kentuckians on Medicaid and has a broad paying-customer base in the state, said it is reviewing the CMS guidance. UnitedHealth Group, which covers more than 91,000 Kentucky Medicaid beneficiaries and has many paying customers in the state, declined the Journal's request for comment.

Chair of U.S. Senate health committee demands maker of weight-loss drugs, most popular in Kentucky, cut their prices by two-thirds

Axios Visuals map, adapted by Kentucky Health News; click it to enlarge.

Sen. Bernie Sanders of Vermont, who chairs the U.S. Senate's Health, Education, Labor and Pensions Committee says the maker of two popular diabetes and weight-loss drugs Ozempic and Wegovy should lower their list prices of “to no more than what they charge for this drug in Canada,” The Washington Post reports.

Sanders, an independent who votes with Democrats, "is demanding that Novo Nordisk slash the prices of its blockbuster drugs Ozempic and Wegovy, citing a new study on the manufacturing costs of the diabetes and weight-loss medications," the Post reports.

Kentucky leads the nation in the percentage (about 2.1%) of residemts who have received a prescription for one of the new drugs created to fight obesity and diabetes, which can also aid weight loss.

"Researchers found that a month’s supply of semaglutide — the active ingredient in both drugs — could be manufactured for an estimated 89 cents to $4.73," the Post reports, but "Novo Nordisk charges $935.77 for four weekly injections of Ozempic in the United States, while it costs about $300 per month out-of-pocket in Canada."

In response, a Novo Nordisk spokesperson didn’t address manufacturing costs but said the Danish company offers several ways to help patients and "supports changes in policy to improve patient affordability and access for those living with chronic diseases," the Post reports.

Heart expert: Ibogaine to treat opioid addiction is safe only in hospitals; others say risk can be mitigated; 'rough' plan outlined

By Melissa Patrick
Kentucky Health News

In a session focused on challenges of getting the psychedelic drug ibogaine approved by the Food and Drug Administration for treating addiction with help of the state's opioid settlement funds, a cardiologist said it couldn't be done in a reasonable time and the drug is unsafe.

"My opinion is that ibogaine is not safe, the efficacy is unproven, it's unlikely to be approved by the FDA in a reasonable time period, and the cost to Kentucky would be unsupportable," said Dr. Mark Haigney, a board-certified cardiologist and electrophysiologist, and an attending physician at the Walter Reed National Military Medical Center.

Haigney was invited to a special Kentucky Opioid Abatement Advisory Commission meeting on Oct. 17 by commission member Patricia Freeman, a pharmacy professor at the University of Kentucky. The meeting also saw the head of the commission discuss a "rough" plan for funding ibogaine research.

Patricia Freeman
(Photos by Melissa Patrick)

After two hearings that focused on ibogaine development and personal testimonies favoring the drug, she asked to invite experts in regulatory drug development to testify about the challenges of navigating ibogaine through the FDA process, given its potential for damage to the heart and its current classification as a Schedule I drug with no medical use.

Freeman said she had concerns that people at one hearing thought there would be quick access to ibogaine with the $42 million investment and felt compelled to ensure they understand that this would be a multi-year endeavor with no guarantee of success. 

"I felt this was important as it would help make sure that at large, our commission would be as fully informed as possible prior to making a decision on proposed ibogaine funding," Freeman said. 

The proposal comes from Bryan Hubbard, chair and executive director of the commission, which operates in the office of Attorney General Daniel Cameron, the Republican nominee for governor. Ibogaine is illegal everywhere but Mexico and New Zealand, but has been anecdotally reported to stop drug-withdrawal symptoms. 

Haigney, who described himself as an "expert in drug-induced sudden death and drug-induced loss of consciousness," said that while he recognized the attractiveness of a single-dose drug like ibogaine to treat opioid-use disorder, such a drug must be "safe in the immediate term, effective in the long term, FDA-approved, and affordable for the huge number of Kentuckians with opioid-use disorder." 

He said ibogaine isn't safe because it is known to cause cardiac arrhythmias and sudden death. In detail, he explained that this happens because ibogaine causes a "prolonged QT interval," which is one of the measurements taken by a standard electrocardiogram. 

A prolonged QT interval occurs when the heart muscle takes longer to contract and relax than usual, which can affect heart rhythms and lead to sudden cardiac arrest. 

Haigney said the FDA requires all drugs to undergo cardiac testing and that "the finding of QT interval prolongation is the most common reason for removal of a drug from further development." 

He added that a prolonged QT interval can happen when a drug blocks the cardiac potassium channels to the heart and that ibogaine is a "potent blocker" of this channel, even with normal therapeutic doses. 

"So this means that most if not all subjects would experience some significant degree of blocking the channel," he said. "And this is a very poor prognostic finding for a drug."

Haigney pointed to a study of 14 hospitalized patients who received a "relatively low dose" of ibogaine. The average increase in QT interval was 95 milliseconds. He said the FDA's published guidelines say it is concerned when a drug prolongs the QT interval by 5 milliseconds or more. 

"I've never seen a drug prolong the QT interval so profoundly," he said, adding later, "This degree of QT prolongation would be expected, associated with increased risk of fatal events."

He then asked rhetorically, "Can this drug be given safely?" His answer, "Yes, in the hospital. We do a lot of dangerous things in the hospital with a lot of technology," adding that this would be "an incredibly resource-demanding" drug to administer. 

"The likelihood that this drug with this safety profile will be approved by the FDA in less than 10 years, in my opinion, is remote and the effort will require at least a billion dollars," Haigney said. "The administration of ibogaine would strain hospital resources at a time when bed shortages are severe. This is a treatment for wealthy individuals who can pay for hospitalization with intensive monitoring," so it would not help most Kentuckians "who struggle with opioid dependence." 

Freeman also invited Robert Walsh, recently retired from working in the National Institute on Drug Abuse for 36 years, where he headed NIDA's Regulatory Affairs Branch. 

Walsh spoke to the regulatory challenges of ibogaine development, including cardiac safety, ensuring enough supply of a plant-based drug from another country, creating a plant-based drug with the same dose in each pill, and the challenges of working with a Schedule I drug in laboratories and clinical settings.

Dr. Sidney Peykar, a cardiac electrophysiologist and medical director at the Cardiac Arrhythmia Institute, said the drug could be given safely in a hospital setting and said he has expanded the protocol for how to administer ibogaine safely at the Beyond Ibogaine Treatment Center in Cancun, Mexico.

"Most if not all of these deaths could be mitigated or completely prevented through safety protocols," he said.

Dr. Javier Muniz, the FDA's supervisory general-health scientist for controlled-substances initiatives, was asked if FDA would definitely not approve ibogaine. He said that without all of the information in front of him, "I have no idea." 

Asked by Freeman if a 95-millisecond QT prolongation would disqualify ibogaine from being approved, he said it's important to remember that when the FDA is considering the approval of a drug, the agency looks at a drug holistically and considers both risks and benefits. 

Bryan Hubbard, right, and
Carlos Cameron, commission
member. 

Hubbard was asked after the meeting if any speaker had caused him to change his mind about his ibogaine plan. He said, "Dr. Haigney was brought in here to oppose this initiative and he articulated all of the talking points that the opponents of this initiative have already parlayed at public remarks. So there was nothing that was either surprising, nor persuasive about his remarks, and insofar as what he has articulated, are already widely publicly disseminated talking points of opposition."

He said Haigney was "thoroughly debunked [by] individuals who serve, respectively, on an FDA advisory board for psychopharmacology, as well as the science journal for the FDA's research arm related to controlled substances."

At the end of the meeting, Hubbard gave the commission a "very rough draft" of a plan with a list of requirements that would have to be met before the commission would commit $42 million to the project. He did not release the plan, but told Kentucky Health News after the meeting that it contains these points:

• "Viable research proposals from qualified research entities" that will match the state's $42 million
• The state would have ownership of any patentable intellectual property that is generated
• Clinical trials would be held in the West End of Louisville and in Wast Kentucky, "in a way that ensures social, racial, and economic equity of access to the treatment,"
• An approved drug-investigation application from the FDA "with secured clinical-trial sites and a diverse group of qualified clinical-trial participants before the first dollar is ever matched by the commission," 

"This will have to be a viable, go project before any commission resources are put on the table," Hubbard said,. Nothing like this has ever been done. So all of this is breaking ground." He cited "the competing interests, the areas of concern, the nature of this money, the necessity of protecting it, the necessity of making sure that the Commonwealth of Kentucky has a leadership position that is protected and recognized, and consideration of risk that we are taking by making this bet."

When it comes time for the commission to vote, he said, "Theoretically, the vote will be to legally authorize a $42 million match from the commission for our clinical research team that is ready to conduct clinical trials with ibogaine in Kentucky."

Hubbard said it is imperative that no vote be taken until Dr. Nolan Williams' peer-reviewed research of veterans who have suffered from traumatic brain injury and received ibogaine is published and they hear from him about his findings. Williams is an associate professor at Stanford University.

At the commission's first public hearing, Williams said he had let other professionals look at the data from his study and they said "the findings are shocking and that they've never seen a drug do this before." 

Before the eight guests spoke, Hubbard took about five minutes to address how he and the commission came to explore ibogaine and its potential therapeutic uses. He said as far back as 2018, he became aware of emerging science on therapeutic psychedelics and an author who at the time wrote about the topic and led him to other sources of information. Her newsletter The Journey is published on Substack. She wrote under the pen name of Julia Blum now uses the name Julia Christina.

Hubbard was responding to an Oct. 9 Daily Beast story, excerpted in Kentucky Health News, which reported that about the time Cameron implicitly endorsed his plan at a public event, a major national political contributor increased its investment in ibogaine research and later gave Cameron's campaign a political boost. He is running against Democratic Gov. Andy Beshear, who has objected to Hubbard's ibogaine plan.

Hubbard said, "It's important to set the record straight in full public view, lest the fictitious narrative of a smoke-and-mirror smear job generated by a third-rate, agenda-driven political tabloid prevail in the public arena against the integrity and sincerity of all who have offered their time, expertise and visceral lived experiences for all the world to see on behalf of all Kentuckians."

The commission's next regular business meeting is scheduled for 1 p.m. Nov. 14 at 1024 Capital Center Dr., Suite 200, Frankfort.

Health insurers, drug companies and other middlemen account for 45% of America's huge health-care bill, up from 25% in 2013

UnitedHealthcare, the largest insurer, is based in Indianapolis.

Kentucky Health News

Americans spend $4.3 trillion a year looking after their health. That is 17% of the nation's gross domestic product, "twice as much as the average in other rich economies, and yet, American adults live shorter lives and American infants die more often than in similarly affluent places," The Economist reports. "Pharmaceutical firms and hospitals attract much of the public ire for the inflated costs. Much less attention is paid to a small number of middlemen who extract far bigger rents from the system’s complexity."

These are the for-profit health-insurance companies, pharmacies, drug distributors and pharmacy-benefit managers (PBMs), which The Economist dubs "Big Health." They account for about 45% of our health-care bill, "up from 25% in 2013," the British-based magazine reports. "Big Health accounts for eight of the top 25 companies by revenue in the S&P 500 index of America’s leading stocks, compared with four for Big Tech and none for Big Pharma."

The largest private health insurer, UnitedHealth Group, took in $324 billion last year, behind only Walmart, Amazon, Apple and ExxonMobil, "and $25 billion in pre-tax profit," The Economost notes. "Four pharmacy giants generate 60% of America’s drug-dispensing revenues. The mightiest of them, CVS Health, alone made up a quarter of all pharmacy sales. Just three PBMs handled 80% of all prescription claims. And a whopping 92% of all drugs flow through three wholesalers." Kentucky has reined in PBMs, now using only one for Medicaid and using the savings to expand the program.

The Patient Protection and Affordable Care Act of 2010 limited health insurers' profits "to between 15% and 20% of collected premiums, depending on the size of the health plan, but it imposed no restrictions on what physicians or other intermediaries can earn," so that "created an incentive for insurers to acquire clinics, pharmacies and the like, and to steer customers to them rather than rival providers," The Economist explains. "The strategy channels revenue from the profit-capped insurance business to uncapped subsidiaries, which in theory could allow insurers to keep more of the premiums paid by patients. . . . Between 2013 and August 2023 the nine health-care giants spent around $325 billion on over 130 mergers and acquisitions."

These businesses "say that bringing all parts of patient care—primary-care clinics, pharmacy services, pbms and insurance—under one roof is beneficial for all. In the old fee-for-service model, big health argues, doctors or hospitals are paid for each service they provide, encouraging them to perform as many as possible and charge as much as they can. If doctors and insurance companies are part of the same business, by contrast, incentives should be aligned and overall costs should be lower," The Economist reports.

"That, at least, is the theory. And there is some truth to it, [but] vertical integration can have adverse side effects. For example, many studies have found that after hospitals acquire physician practices, prices increase but quality of care does not. A health-care company that controls many aspects of patient care could raise prices for rivals wishing to access its network. Some also worry about physicians being nudged towards offering the cheapest treatment to patients, lowering the quality of care."

5 things to know about new Medicare negotiations on drug prices

By Arthur Allen, Rachana Pradhan and David Hilzenrath

KFF Health News

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for seniors and, eventually, other Americans.

Under the 2022 Inflation Reduction Act, Congress gave the federal government the power to negotiate prices for certain high-cost drugs under Medicare. The list of drugs selected by the Centers for Medicare and Medicaid Services will grow over time.

The first eligible drugs treat diabetes, blood clots, blood cancers, arthritis, and heart disease — and accounted for about $50 billion in spending from June 2022 to May 2023.

The United States is clearly an outlier on drug costs, with drugmakers charging Americans many times more than residents of other countries “simply because they could,” Biden said Aug. 29. “I think it’s outrageous. That’s why these negotiations matter.”

Democratic lawmakers cheered the announcement, and the pharmaceutical industry, which has filed a raft of lawsuits against the law, condemned it.

The companies have until Oct. 2 to present data about their drugs to CMS, which will make initial price offers in February, starting negotiations set to end next August. The prices would take effect in January 2026.

Here are five things to know about the impact:

1. How important is this step? Medicare has long been in control of the prices for its services, setting physician payments and hospital payments for about 65 million Medicare beneficiaries. But it was previously prohibited from involvement in pricing prescription drugs, which it started covering in 2006.

Until now the drug industry has successfully fought off price negotiations with Washington, although in most of the rest of the world governments set prices for medicines. While the first 10 drugs selected for negotiations are used by a minority of patients — 9 million — CMS plans by 2029 to have negotiated prices for 50 drugs on the market.

“There’s a symbolic impact, but also Medicare spent $50 billion on these 10 drugs in a 12-month period. That’s a lot of money,” said Juliette Cubanski, deputy director of the Kaiser Family Foundation’s analysis of Medicare policy.

The long-term consequences of the new policy are unknown, said Alice Chen, vice dean for research at University of Southern California’s Sol Price School of Public Policy. The drug industry says the negotiations are essentially price controls that will stifle drug development, but the Congressional Budget Office estimated only a few drugs would not be developed each year as a result of the policy.

Biden administration officials say reining in drug prices is key to slowing the skyrocketing costs of U.S. health care.

2. How will the negotiations affect Medicare patients? In some cases, patients may save a lot of money, but the main thrust of Medicare price negotiation policy is to provide savings to the Medicare program — and taxpayers — by lowering its overall costs.

The drugs selected by CMS range from specialized, hyper-expensive drugs like the cancer pill Imbruvica (used by about 26,000 patients in 2021 at an annual price of $121,000 per patient) to extremely common medications such as Eliquis (a blood thinner for which Medicare paid about $4,000 each for 3.1 million patients).

While the negotiations could help patients whose Medicare drug plans require them to make large copayments for drugs, the relief for patients will come from another segment of the Inflation Reduction Act that caps drug spending by Medicare recipients at $2,000 per year starting in 2025.

3. What do the Medicare price negotiations mean for those not on Medicare? One theory is that reducing the prices drug companies can charge in Medicare will lead them to increase prices for the privately insured.

But that would be true only if companies aren’t already pricing their drugs as high as the private market will bear, said Tricia Neuman, executive director of KFF’s program on Medicare policy.

Another theory is that Medicare price negotiations will equip private health plans to drive a harder bargain. David Mitchell, president of the advocacy group Patients for Affordable Drugs, predicted that disclosure of negotiated Medicare prices “will embolden and arm private sector negotiators to seek that lower price for those they cover.”

Stacie B. Dusetzina, a professor of health policy at Vanderbilt University, said the effect on pricing outside Medicare isn’t clear: “I’d hedge my bet that it doesn’t change.”

Dusetzina described one way it could: Because the government will be selecting drugs for Medicare negotiations based partly on the listed gross prices for the drugs — distinct from the net cost after rebates are taken into account — the process could give drug companies an incentive to lower the list prices and narrow the gap between gross and net. That could benefit people outside Medicare whose out-of-pocket payments are pegged to the list prices, she said.

4. What are drug companies doing to stop this? Even though negotiated prices won’t take effect until 2026, drug companies haven’t wasted time turning to the courts to try to stop the new program in its tracks.

At least six drug companies have filed lawsuits to halt the Medicare drug negotiation program, as have the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, known as PhRMA.

The lawsuits include a variety of legal arguments. Merck & Co., Johnson & Johnson and Bristol Myers Squibb are among the companies arguing their First Amendment rights are being violated because the program would force them to make statements on negotiated prices they believe are untrue. Lawsuits also say the program unconstitutionally coerces drugmakers into selling their products at inadequate prices.

“It is akin to the government taking your car on terms that you would never voluntarily accept and threatening to also take your house if you do not ‘agree’ that the taking was ‘fair’,” Janssen, part of Johnson & Johnson, wrote in its lawsuit.

Nicholas Bagley, a law professor at the University of Michigan, predicted the lawsuits would fail because Medicare is a voluntary program for drug companies, and those wishing to participate must abide by its rules.

5. What if a drug suddenly gets cheaper by 2026? In theory, it could happen. Under guidelines CMS issued this year, the agency will cancel or adjourn negotiations on any drug on its list if a cheaper copycat version enters the market and finds substantial buyers.

According to company statements this year, two biosimilar versions of Stelara, a Johnson & Johnson drug on the list, are prepared to launch in early 2025. If they succeed, it would presumably scotch CMS’ plan to demand a lower price for Stelara.

Other drugs on the list have managed to maintain exclusive rights for decades. For example, Enbrel, which the FDA first approved in 1998 and cost Medicare $1.5 billion in 2021, will not face competition until 2029 at the earliest.

Attorney general files lawsuit against pharmacy benefit managers, manufacturers over alleged insulin pricing scheme

By Melissa Patrick

Kentucky Health News

Attorney General Daniel Cameron has filed a lawsuit against three pharmacy benefit managers and drug manufacturers over an alleged insulin pricing scheme.   

The lawsuit alleges that PBMs CVS Caremark, Optum Rx, and Express Scripts along with manufacturers Eli Lilly, Novo Nordisk and Sanofi have worked together to manipulate and increase insulin prices. 

PBMs act as middlemen between insurance plans and drug manufacturers; they determine what drugs are offered, how much someone pays for the drug, and how much the pharmacists are paid.

This graphic from the lawsuit "shows how collectively the manufacturers have exponentially raised
the prices of insulin products in near unison," the attormey general's news release says. 

A Cameron news release said, "The lawsuit alleges that instead of using such leverage to negotiate lower prices for their customers, PBMs have sought to increase their own profits by raising insulin prices. In that scheme, the insulin manufacturers artificially and willingly raised their reported prices and then deceptively refunded a significant portion of that price to PBMs through rebates, discounts, credits, and administration fees. . . . Executives for PBMs recently testified that between 75 and 84 cents of every dollar spent on insulin goes directly to affiliates of PBMs." 

The 133-page lawsuit states, "Insulins, which today cost manufacturer defendants less than $2 to produce and which were originally priced at $20 when released in the late 1990s, now range between $300 and $700." 

Cameron said in the release, “I understand the pain inflicted on Kentucky families by unfair and inflated insulin prices. The unlawful business practices that drove these increases have to end, and normal market forces must be allowed to lower the cost of insulin for all Kentuckians.”

Nearly 450,000 Kentuckians live with diabetes, and an additional 1.1 million are prediabetic.

Kentucky #insulin4all Chapter Advocate Angela Lautner told WKYT that it's time for both manufacturers and PBMs "to be held accountable for the massive insulin prices we see here in the United States" and questioned why they exist at all. 

“These lawsuits have been going on for a number of years, and it’s time that they come to a conclusion,” Lautner told the Lexington TV station. “Everybody knows that we are being taken advantage of and lives are literally being lost because of greed.”

Attorneys general from Arkansas, California, Illinois, Kansas, Louisiana, Mississippi, Montana, and Ohio have filed similar lawsuits in their states. 

Kentucky lawmakers have been working on PBM issues for years, most recently passing 2020 Senate Bill 50 that among other things, required the state to hire a single PBM to manage Kentucky Medicaid's prescription-drug business of more than $1 billion a year. Kentucky has saved at least $38 million from this move, money Gov. Andy Beshear has used to expand Medicaid benefits over objections of the Republican-controlled legislature. He and Cameron are running for governor. 

Comer says his panel will investigate pharmacy benefit managers

Rep. James Comer chairs the Oversight Committee.

As chair of the House Oversight and Accountability Committee, Republican U.S. Rep. James Comer of Kentucky's First District is launching an investigation into pharmacy benefit managers and how they affect health-care costs. 

PBMs manage prescription-drug benefits for public and commercial insurers, acting as middlemen between them and drug companies. Comer said PBMs drive up drug prices, an assertion the industry disputes.

Comer, R-Frankfort and Tompkinsville, is asking the three largest PBMs, CVS Caremark, Express Scripts and OptumRx, to provide "documents, communications, and information related to their practices that are distorting the pharmaceutical market and limiting high-quality care for patients" by March 15.

When The Washington Post asked the companies for comment, they handed off to the Pharmaceutical Care Management Association, their main lobby. It issued a statement saying, “While we appreciate — and share — the committee’s concern around drug pricing and existing gaps in affordability, we strongly urge members of the committee and Congress to stay focused on real solutions that are proven to reduce prescription-drug costs.” It said they “have a proven track record of reducing prescription-drug costs in federal programs.”

Comer is also seeking information from the Office of Personnel Management, the Centers for Medicare and Medicaid Services and the Defense Health Agency to determine PBMs’ impact on federal health-care programs.

One of Comer's political allies, state Sen. Max Wise, R-Campbellsville, until recently led efforts in the state legislature to more tightly regulate PBMs.

Lilly says it will cut prices of 2 old insulin products 70% this year, and immediately cap the cost of another one at $25 per vial

Eli Lilly & Co. announced Wednesday that it will cut the prices of some of its older insulin products this year "and immediately expand a cap on costs insured patients pay to fill prescriptions," The Associated Press reports.

That will provide "critical relief to some people with diabetes who can face annual costs of more than $1,000 for insulin they need in order to live," AP's Tom Murphy writes. "Lilly’s changes also come as lawmakers and patient advocates pressure drugmakers to do something about soaring prices."

Lilly said it will cut by 70 percent the list prices for its most-prescribed insulin, Humalog, and for another one, Humulin, in the fourth quarter of the year, which starts in September. "The drugmaker didn’t detail what the new prices would be," Murphy notes. "List prices are what a drugmaker initially sets for a product and what people who have no insurance or plans with high deductibles are sometimes stuck paying."

Stacie Dusetzina, a health policy professor at Vanderbilt University who studies drug costs, told Murphy that the changes probably won’t affect Indianapolis-based Lilly much financially because the two insulins already have competition.

The authorized generic version of another Lilly insulin, Humalog, will be cut to $25 a vial starting in May. "The cost of a prescription for generic Humalog ranges between $44 and close to $100 on the website GoodRx," Murphy notes.

Lilly's Indianapolis headquarters (Photo by Darron Cummings, AP)

Lilly CEO David Ricks said in a press release that it will take some time for insurers and the pharmacy system to implement the price cuts, so the company will immediately cap monthly out-of-pocket costs at $35 for people who are not covered by Medicare’s prescription-drug program. It said the cap applies to people with commercial coverage and at most retail pharmacies.

Medicare started applying that cap in January, as part of recent legislation.

"Aside from Eli Lilly and the French drugmaker Sanofi, other insulin makers include the Danish pharmaceutical company Novo Nordisk," Murphy reports. "Lilly also is launching in April a biosimilar insulin to compete with Sanofi’s Lantus."

Insulin is an essential hormone that converts food into energy. "People who have diabetes don’t produce enough insulin," Murphy notes. "People with Type 1 diabetes must take insulin every day to survive. More than 8 million Americans use insulin, according to the American Diabetes Association. Research has shown that prices for insulin have more than tripled in the last two decades, and pressure is growing on drugmakers to slow the increases."

Drug manufacturer may be seeing “the writing on the wall that high prices can’t persist forever,” said Larry Levitt, an executive vice president with the nonprofit Kaiser Family Foundation, which studies health care, told Murphy. “Lilly is trying to get out ahead of the issue and look to the public like the good guy.”

Lilly was the first company to commercialize insulin in 1923, "two years after University of Toronto scientists discovered it," Murphy notes. "The drugmaker then built its reputation around producing insulin even as it branched into cancer treatments, antipsychotics and other drugs."

Pfizer's $1 million leads big corporate givers to state Republican Party's building fund, which has no limits on contributions

The Republican Party plans to expand its headquarters into the vacant lot on Third Street in Frankfort, spokesman Sean Southard told Kentucky Health News. (Photo by Tom Loftus for Kentucky Lantern)

By Tom Loftus, for Kentucky Lantern

FRANKFORT, Ky. – In what may be the largest political contribution ever given to a political party in Kentucky, the drug maker Pfizer Inc. gave $1 million last month to the building fund of the Republican Party of Kentucky.

A report filed by the Republican Party of Kentucky Building Fund last week with the Kentucky Registry of Election Finance listed the $1 million from Pfizer along with five other big corporation contributions in the final quarter of 2022 totalling $1.65 million.

That is an extraordinarily large haul for the fund, which had raised only $6,000 during the first three quarters of 2022. The other large corporate donors to the fund in late 2022 were:

• Metropolitan Life Insurance Co., New York, $300,000;
• Altria Client Services LLC, of Richmond, Va., $100,000;
• Comcast Corp., of Philadelphia; $100,000;
• AT&T, of St. Louis; $100,000;
• Delta Air Lines, of Atlanta, $50,000.

State and federal campaign finance laws set limits on how much a person or political action committee can give to the executive committee of a political party. A person can give no more than $15,000 per year, and corporation contributions to a party’s executive committee are prohibited.

But part of a campaign-finance bill passed by the General Assembly in 2017 allowed each party to establish a building fund that can accept contributions of unlimited amounts. It also allowed the building funds to accept contributions from corporations.

The Kentucky Democratic Party’s building fund has not yet filed a report on its contributions and expenses for the last quarter of 2022. The party has started a four-year process of selling its headquarters near the Interstate 64 and Versailles Road interchange in Frankfort.

The Republican Party's headquarters are at Capital Avenue and Third Street in Frankfort, in a building named for U.S. Senate Republican Leader Mitch McConnell.

The election registry website says that money in a party building fund “may be used for expenditures related to the purchase, construction, maintenance, renovation, and repair of the state executive committee’s main headquarters facility.”

In response to questions from Kentucky Lantern, Sean Southard, spokesman for the Republican Party of Kentucky, released a statement Monday that said in part “The Republican Party purchased the lot next door to our Frankfort headquarters and is planning an expansion project. Our current headquarters was acquired in 1974. With the growth of the Republican Party in Kentucky, we have a need for additional space.”

In response to a question about the huge size of the corporate contributions, Southard’s statement said, “As we raise funds into the building fund account, we are following both federal and state law. The funds raised into this account can only be used for certain expenditures related to the building and are not eligible to be spent on candidate or issue advocacy.”

Pfizer has long had a lobbying presence in Kentucky and for years it has retained the lobbying firm headed by John McCarthy to represent its interests in Frankfort.

McCarthy, a former chairman of the Republican Party of Kentucky and still a member of its executive committee, did not immediately return phone messages seeking comment on the Pfizer contribution.

Pfizer is a multinational pharmaceutical and biotech company based in New York; its brands include Viagra, Zoloft and Lipitor and more recently the Pfizer-BioNTech Covid-19 vaccine and the antiviral Paxlovid.

Fueled by sales of its Covid vaccine, Pfizer’s revenue doubled to $81.3 billion from 2020 to 2021. The company ranks 43rd on the Fortune 500 list. For the first three quarters of 2022, Pfizer reported $76 billion in revenues.

Pfizer announced in November that it will triple or even quadruple the price of its Covid vaccine once it goes on the commercial market next year, according to Kaiser Health News.

Pfizer is no stranger to political spending. In 2022, the company spent $11.6 million lobbying the federal government, putting it in the top dozen lobbying spenders, according to Open Secrets. Its affiliates and PAC contribute generously to federal candidates of both parties.

Altria Client Services (a subsidary of a cigarette manufacturer formerly known as Phillip Morris), AT&T, Comcast and Delta also are registered to lobby the Kentucky General Assembly. Metropolitan does not retain a lobbyist in Frankfort, according to records of the Legislative Ethics Commission.

Commission handling opioid-abatement settlement funds will have its first town-hall meeting from 6 to 8 p.m. Monday in Pikeville

The first in a series of town-hall meetings by state commission overseeing distribution of $478 million Kentucky received in a settlement with drug makers is scheduled for 6 to 8 p.m. Monday, Sept. 19 in Pikeville.

The meeting will be held by the Opioid Abatement Advisory Commission at The Overlook, 891 Bob Amos Drive. The meeting agenda is available here.

After the commission is introduced and its work is explained, it will hear comments from the public in this order, as described in the agenda: individuals living with opioid-use disorder,. family members of those living with the disorder, family members who lost loved ones to it, and other attendees.

The commission's seven other town-hall meetings will be held from 6 to 8 p.m. local time on these dates and at these places:
Sept. 27: Ashland – The Train Depot, 99 15th St.
Oct. 11: Hazard – The Forum, 101 Bulldog Lane
Oct. 18: Covington – Kenton County Govt. Center, 1840 Simon Kenton Way
Oct. 26: Lexington – UK Student Center, 160 Avenue of Champions
Nov. 1: Louisville – Simmons College, 1000 S. Fourth St.
Nov. 9: Bowling Green – WKU Conference Center, 2355 Nashville Road
Nov. 29: Paducah – Convention Center, 415 Park St.

Doctors back booster shots for recent Covid-19 variants, saying vaccines are especially needed now that cooler weather is here

iStock/Getty Images Plus photo illustration via Kaiser Health News

By Al Cross

Kentucky Health News

Kentucky experts largely dismissed concerns about speedy approval of the new coronavirus vaccines on "Kentucky Tonight," a Kentucky Educational Television program, Monday night.

Ilhem Messaoudi, chair of microbiology at the University of Kentucky, said she has been surprised at people who she said are "up in arms" about the lack of human testing on the vaccines, which target the major subvariants of the Omicron variant of the virus.

She said the vaccines were developed with the same technology used for the original vaccine, tweaked "just like we tweak the flu vaccine every year" without testing the tweaked vaccine on humans.

Ilhem Messaoudi, Ph.D. (Image from KET)

Messaoudi said clinical trials in humans could have taken so long that new variants could become dominant, making them largely useless. "This just required a very quick response," she said.

Dr. Fadi al Akhass of the Pikeville Medical Center agreed. "That virus is very smart," he said. "It can tweak its genetic material very quickly."

That factor was more important than usual because of the calendar. Cool weather is arriving and people are spending more time indoors, where infeciton is likelier.

Food and Drug Administration Commissioner Robert Califf said at a news conference last week that waiting for human trials "would have meant that a fall or winter Covid-19 wave could have arrived without updated vaccines," Priyanka Runwal reports for National Geographic. "Moderna and Pfizer-BioNTech are now conducting human clinical trials to test the safety and efficacy of the modified boosters, but Califf encourages those eligible to get their shots soon."

Still, the limited testing in mice means “We don’t know … how well this is going to work in the real world,” John Swartzberg, an infectious-disease expert at the University of California, told Runwal, who adds, "To what extent these modified shots will reduce reinfections and breakthrough ones remains unknown.

After an FDA committee overwhelmingly approved the vaccines 13-1, the Centers for Disease Control and Prevention recommended that anyone 12 and older who has received at least two doses of the original Covid-19 vaccines get a new one as a booster against the newer variants.

Some on the committee "said they set aside their desire for more information and better data and voted yes out of fear of a potential winter Covid surge, Celine Grounder and Elisabeth Rosenthal report for Kaiser Health News. "They expressed hope that the new vaccines — or at least the vaccination campaign that would accompany their rollout — would put a dent in the number of future cases, hospitalizations, and deaths."

Pfizer presented studies showing that its updated booster provides 1.56 times more neutralizing antibody titers against the Omicron BA.1 virus than a booster using the original vaccine. Moderna’s studies "demonstrated very similar results," Grounder and Rosenthal report. "However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5% and 1% respectively."

Grounder and Rosenthal note a difference in tweaking flu and Covid-19 vaccines: "With flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That’s not the case with Covid vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now."

Still, the experts on the KET program said Kentuckians should get the new vaccines. As they spoke, the state's rate of new coronavirus infections was the highest in the nation, according to The New York Times. 

"Covid is even more ubiquitous than it has been in the past," said Dr. Mark Dougherty of Baptist Health Lexington. "We're still having nearly 400 patients a day die in the United States. That equates to 120 to 140,000 deaths a year, which is much more than the normal influenza year."

Messaoudi recommended getting a flu shot at the same time, since there are no issues with that. "Our immune system can handle more than one antigen at the same time," and does do "on a daily basis," she said.

Dougherty said many people have caught the coronavirus and passed it on to others without knowing it because they had no symptoms. He said as many as 40% of people infected may not feel well for three months, suffering loss of taste and smell, abnormal taste, or fatigue. "It is having a huge impact on a large number of people."

UPDATE, Sept. 13: Susan Dunlap, spokeswoman for the state Department for Public Health, also supported the vaccines and their approval. She said in an email Tuesday, "With more than 610 million doses administered across our nation, Covid-19 vaccines approved for use in the United States have demonstrated themselves to be safe, well-tolerated, and highly effective. Even so, the ongoing evolution of the virus warrants evolution of the vaccine in an effort to improve vaccine effectiveness. The FDA’s decision to approve and CDC’s decision to recommend new bivalent Covid-19 vaccines for the fall and winter of 2022 is a reasonable and responsible step to save lives and keep society in motion."

Pharmacy benefit managers' group ranked No. 7 in spending for lobbying the General Assembly, after laying out $53,634 for ads

Commonwealth Fund flow chart, amended by Kentucky Health News to include patients and employers

By Al Cross
Kentucky Health News

The lobbying organization for pharmacy benefit managers, the middlemen between insurance companies and drug manufacturers, spent $86,168 in its successful effort to defeat a bill in the recent legislative session that would have reined them in. They prevailed over pharmacists with the help of insurers, who argued that the bill would raise costs.

The Pharmaceutical Care Management Association ranked seventh in spending by lobbying interests in the session that ended in mid-April, mainly because it spent tens of thousands of dollars in television commercials attacking the bill. The ads started the day the bill overwhelmingly passed the House, where a pharmacist-legislator was the sponsor. PCMA said it spent a total of $53,634 on TV, internet and newspaper ads.

The bill got nowhere in the Senate, where President Robert Stivers said "When it got here, we started getting, from business sector and provider sector, various questions and comments about what the overall cost would be to various plans."

Tom Stephens, executive director of the Kentucky Association of Health Plans, cited a state Department of Insurance statement that a family of four would have paid up to $167 more a year for coverage if the bill had passed.

House Bill 457 would have ensured that patients could pick their pharmacy, instead of being required to use one affiliated with a pharmacy benefit manager; increase transparency between insurers and PBMs; and ban PBMs from retroactively denying a pharmacy claim after adjudication, commonly referred to as "clawing back." It passed the House 88-3.

The Federal Trade Commission voted Tuesday to investigate how pharmacy benefit managers affect the cost of prescription drugs and consumers' access to the drugs.

Several other health-care interests, or lobbying groups with interests in health care, were big spenders on lobbying the session, according to their post-session reports. The Kentucky Chamber of Commerce was again No. 1, spending $183,949; the Kentucky Hospital Association was second with $149,046. Third and fourth were the American Civil Liberties Union of Kentucky, whose issues include abortion rights, $128,258, and Altria Client Services (Philip Morris Cos.), $126,793. Insurer Anthem Inc. ranked 10th by spending $70,597.

Other big health spenders were the Kentucky Medical Association, 16th, at $54,044, and HCA Healthcare, 22nd at $48,832. The state Legislative Ethics Commission’s searchable register of lobbyists, employers and lobbying expenses is online at http://apps.klec.ky.gov/searchregister.asp.

Drug companies' settlement with states and local governments will bring Kentucky $483 million over the next 18 years

The state has finalized a $483 million settlement with four drug companies over their roles in the opioid epidemic, and payments should start in the second quarter of the year, Attorney General Daniel Cameron said Friday.

The 18-year agreement with drug distributors Cardinal Health, McKesson, AmerisourceBergen and manufacturer Johnson & Johnson ends "years of negotiations to resolve more than 4,000 claims of state and local governments across the country," a press release from Cameron's office said. "It is the second largest multistate agreement in U.S. history, second only to the Tobacco Master Settlement Agreement," which settled lawsuits against cigarette makers for health impacts of smoking.

Atty. Gen. Daniel Cameron

Cameron, a Republican, said he would "work closely with the legislature and local governments to ensure the funds are put toward programs that will stop the cycle of addiction and help heal our communities.” The state will get half the money, and the other half will go to local governments through an application process of the new Opioid Abatement Advisory Commission.

The four companies also agreed to:

• Create a clearinghouse to provide all three drug distributors and state regulators with data and analytics about where drugs are going and how often, "eliminating blind spots in the current systems used by distributors," the release said.
• Use data systems to detect and report suspicious opioid orders from pharmacies, and ban shipments of such orders.
• When pharmacies "show certain signs of diversion, stop their shipments and report them to state regulators.
• Prohibit their sales staff from influencing decisions related to identifying suspicious opioid orders, and require senior executives regularly examine anti-diversion efforts.

Johnson & Johnson is required to:

• Stop selling opioids.
• Not fund or provide grants to third parties for promoting opioids.
• Not lobby on activities related to opioids.
• Share clinical trial data under the Yale University Open Data Access Project.

Capacity limits going to 60% for many; Beshear says Monday's numbers make 'the most optimistic report I've been able to give'

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

By Melissa Patrick

Kentucky Health News

Following seven weeks of declining coronavirus cases and positive-test rates, along with an increasing supply of vaccines, Gov. Andy Beshear announced that many businesses would be able to increase their capacity limits, starting Friday, from the current 50% to 60%.

Beshear called the step a "watch and see" situation and called on Kentuckians to be flexible. 

“With more aggressive variants out there, which are expected to become the dominant strains, we cannot stop masking, we cannot stop doing the things that we know that tamps down this virus,” he said at a news briefing. “If we do and the cases go back up, we have to be prepared to take the opposite step that we are taking today. And I won’t be hesitant about doing so.”

State chart; click to enlarge. List also includes event venues.

Businesses and venues that will be allowed to increase their capacities include bars, restaurants, government offices, retail stores, movie theaters, barber shops, hair salons and cosmetologists. 

Beshear also said he plans to increase capacity of child-care centers to "regular group size" March 15 if positive trends continue.

Other states are allowing more capacity in restaurants and public gatherings despite dire warnings from health experts who say the pandemic is far from over, and moving too quickly could prolong it, The Associated Press reports.

Centers for Disease Control and Prevention Director Rochelle Walensky warned Americans and their leaders not to relax, saying she is "really worried about reports that more states are rolling back the exact public-health measures that we have recommended," AP reports. Citing current figures, she said “We cannot be resigned to 70,000 cases a day and 2,000 daily deaths.”

Daily numbers: Beshear called Monday's numbers "the most optimistic report I've been able to give you since the very beginning of the pandemic."

State Dept. for Public Health graph, relabeled by Kentucky Health News; to enlarge, click on it.

He said the share of Kentuckians testing positive for the virus in the past seven days dropped below 5%, to 4.84%, the lowest its been since Oct. 18. 

The World Health Organization and other health officials consider below 5% to represent low transmission, but the WHO says it needs to be below 5% for two weeks before restrictions are eased.

Beshear reported 509 new coronavirus cases, the lowest daily figure in five months. The seven-day rolling average is 1,091, down three from yesterday.

Only 25 of the state's 120 counties are in the "red zone" for counties with 25 cases per 100,000 people. 

Kentucky's new-case rate is the 11th highest in the nation, according to The New York Times. The state says the new-case rate over the last seven days is 20.52 per 100,000 people. Counties with double that rate are Russell, 42.2; Knox, 43.1; Clay, 45.9; Lyon, 57.4; Owsley, 58.2; Taylor, 61; and Caldwell, 240.

The Pennyrile District Health Department said an outbreak at the West Kentucky Correctional Complex in Lyon County was incorrectly attributed to Caldwell County because its mailing address is Fredonia, which is in Caldwell. The state Corrections Department report said 232 of the 253 active cases among inmates, and 19 of the 32 staff cases, are at the prison.

Hospital numbers remain stable, with 719 people hospitalized with Covid-19 (down 13 from yesterday); 180 in intensive care (down 7); and 82 of those on a ventilator (down 36, perhaps reflecting a reporting anomaly on Sunday). All of these numbers have been trending down.

Two of the state's 10 hospital readiness regions are using at least 80% of their intensive care beds: Lake Cumberland, 98% and the easternmost region from Lee to Pike counties, 92%. 

Vaccines: Beshear said Kentucky will get 36,500 doses of the single-dose Johnson & Johnson vaccine this week and will send it to local health departments and more than 130 independent pharmacies. This is the third vaccine authorized for emergency use against the coronavirus in the U.S. 

"That is another victory and a closer step to winning this war against Covid-19," he said.  "Like the other vaccines, it protects, almost eliminates, severe disease and the possibility of death." 

On NBC's "Meet the Press" Sunday, Dr. Anthony Fauci, the nation's leading infectious-disease expert, urged Americans to take whatever vaccine is available to them when they are eligible. He said that if he were not vaccinated, he would take any of the three approved vaccines because they all provide strong protections from severe disease related to the virus.

Kentucky's daily vaccine report shows 699,398 Kentuckians have received their first dose of either the Pfizer-BioNTech or Moderna vaccine. And with the addition of the Johnson & Johnson vaccine, Beshear said he expects that number to double in the next month.

On Monday, Kentucky opened up vaccinations to people in the 1C category, which includes all essential workers, people 60 and older, and anyone 16 and older with certain health conditions. 

Beshear confirmed today that the 181 state prisoners who are 70 and older will be included in the 1C distribution of vaccines and that details were still being worked out on how to accomplish that. 

Cabinet for Health and Family Services Inspector General Adam Mather said the federal long-term care vaccine program is wrapping up. He said the state would move to a "maintenance" program to ensure that new residents, new staff and reluctant residents and staff would be able to be vaccinated. 

Deaths: The state added 15 more Kentuckians to its list of Covid-19 fatalities, all of them confirmed. That brings Kentucky's death toll to 4,652. The 14-day death average is 25.8, up from 25.4 yesterday. 

Beshear said deaths have been under-reported since mid-November because a busy state employee stopped comparing all death certificates that listed Covid-19 as a cause of death against deaths reported by health departments, Beshear said. He said the state has resumed these audits again, but it's too early to guess how many deaths will be added. When Ohio discovered a similar problem, it added 4,000, The New York Times reported.

"I am committed to honoring all of those lost by making sure each is counted," the governor said. "We can have no unknown loss and no unknown soldiers.”

In other pandemic news Monday:

• The 15 fatalities were a Knott County man, 77; a Laurel County woman, 72; a Laurel County man, 72; three Letcher County women, 76, 85 and 91; three Letcher County men, 60, 75 and 94; three Perry County men, 52, 56 and 85; a Whitley County woman, 78; and two Whitley County men, 39 and 44. 
• Counties with 10 or more new cases are Jefferson, 95; Boone, 31; Kenton and Laurel, 21; Warren, 17; Bullitt and Knox, 16; Campbell, 12; and Boyd, 10. 
• Beshear reported that the Lee County Health Department lost power and was flooded, but its supply of coronavirus vaccines were saved by Scott Lockard, director of the Kentucky River District Health Department, and his team, along with Lee County Emergency Management. 
• Preliminary data shows that the Pfizer-BioNTech vaccine can reduce severe Covid-19 infections in seniors, according to a report published by the CDC. In about three months, with two-dose vaccination coverage at 84% among those 70 and older and 10% among those 50 and older, the vaccine lowered the need for mechanical ventilation among people 70 and older by 67%, compared to those younger than 50. The study was conducted in Israel, which has the highest vaccination rate in the world. 
• UPS Worldport in Louisville has received its first truck full of the Johnson & Johnson vaccine, newly approved for emergency use, on Monday, WDRB reports. The facility also played an integral role in getting the previous vaccines distributed after they were approved. The vaccine kits are being assembled and shipped from a J & J facility in Bullitt County.
• J & J intends to deliver 20 million vaccines to Americans this month and 100 million doses by June, Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer for the company, told CNN March 1.
• Corinne Boyer of WEKU talked to a vaccine expert at the University of Kentucky who answers questions about the vaccines.