Sunday, March 31, 2024

State House kills bill that would have banned Covid-19 vaccine mandates, after it takes a fast, unusual trip through the Senate

Kentucky Health News

A bill that would have banned Covid-19 vaccines from being required for employment, student enrollment or activities, or medical treatment and licensing, died a quiet death in the state House after a fast and unusual trip through the Senate in the closing days of the legislative session.

The sponsor used misleading information in committee, some of her Republican colleagues made speeches on the Senate floor against it, and after it passed, her news release was changed because it cited a study that had been withdrawn from publication by a scientific journal. All in less than a week.

Sen. Lindsey Tichenor (LRC photo)
Senate Bill 295, sponsored by Sen. Lindsey Tichenor, R-Smithfield, passed the Senate 25-11 on March 26 but was never given a committee assignment in the House.

When Tichenor presented the bill to the Senate Health Services Committee, she said "mass vaccination mandates" have caused an "unprecedented rise . . . in sudden deaths among all ages" and said the number of "deaths and adverse events" reported to the federal Vaccine Adverse Event Reporting System (VAERS) "total more than all other vaccines combined" since the system started in 1990.

There have been no mass mandates ijn the U.S. for any the Covid-19 vaccines, though some employers and schools have required them. Anyone can file a report with VAERS, without any supporting documentation, and  claims are then evaluated by VAERS staff to determine if intervention is needed.

"Anti-vaccination fringe groups have attempted to spin false stories using VAERS data, adding to misinformation about the safety of Covid-19 vaccinations," reports Amy Dusto of Johns Hopkins University. The Centers for Disease Control and Prevention says:
  • The benefits of Covid-19 vaccination continue to outweigh any potential risks.
  • Severe reactions after Covid-19 vaccination are rare.
  • CDC recommends everyone ages 6 months and older get vaccinated to protect against Covid-19 and its potentially severe complications.
  • Millions of people in the United States have received Covid-19 vaccines under the most intense safety monitoring program in U.S. history.
  • CDC, the U.S. Food and Drug Administration and other federal agencies continue to monitor the safety of Covid-19 vaccines.
Nevertheless, Sen. Donald Douglas of Nicholasville, a physician, praised Tichenor for filing the bill. "This is a place where most people would want to go," he said. "They don't want to take the heat." The committee passed the bill by a vote of 8-2.

On the Senate floor, Tichenor said the bill protects “individual liberties,” but some of her colleagues said employers, especially those in health care, should be able to require vaccination.

“With passage of this legislation, we’re saying a hospital cannot require their employees to have any Covid-19 vaccine,” said Senate President Pro Tempore David Givens, R-Greensburg.

Sen. Whitney Westerfield, R-Fruit Hill (Christian County), said the bill would tie business owners’ hands. “That’s wrong,” he said. “They might want to require this. They might absolutely not require this. They should be allowed to make that decision.” He added, “We should be very careful about bills” that boost conspiracy theories.

After the bill passed the Senate 25-11, the office of the Senate Republican majority issued a press release about it, but withdrew parts of it after being told that a study it cited "had been retracted by a scientific journal," report Alex Acquisto and Austin Horn of the Lexington Herald-Leader.

In the release, "Tichenor said the vaccine was 'ineffective and dangerous' and linked to a research paper buttressing her point, saying, 'Reports supporting the need for this legislation may be found here.' But that paper had been formally retracted on Feb. 26 for drawing 'unreliable' conclusions, 'concerns with the validity of some of the cited references,' as well as a 'misrepresentation' of data," Acquisto and Horn report. "Senate GOP staff later sent a statement from Tichenor calling it a 'simple error'." She also said the authors of the paper are filing a lawsuit for "unethical retraction."

Only one of the paper's seven authors "is currently employed at an academic institution," Acqutso and Horn report, and "that author, Stephanie Seneff, has long been an anti-vaccine advocate. She has made the false claim that the measles, mumps, and rubella vaccine causes autism."

Tichenor acknowledged Thursday that her bill was dead. Asked if she had tried to attach it to another bill, in order to get it before the House, she said, "I had tagged it on, but it didn't stick."

Information for this story was also gathered by Sarah Ladd of the Kentucky Lantern.

Saturday, March 30, 2024

Beshear gets bill to limit vaping products to those OKd by FDA; Ky. Youth Advocates calls for enforcement of underage-sales law

By Melissa Patrick
Kentucky Health News

A bill to reduce underage vaping by limiting legal sales to products approved by the U.S. Food and Drug Administration, and creating a database of retailers that sell the products, passed the legislature in its closing minutes Thursday night and was delivered to Gov. Andy Beshear for his signature or veto. 

Opponents of the bill say it would not curb underage use of vape products, but will hurt small businesses and help large companies that lobbied for it. 

Rep. Rebecca Raymer
House Bill 11, sponsored by Rep. Rebecca Raymer, R-Morgantown, was amended in the Senate to include parts of Senate Bill 344, sponsored by Sen. Brandon Storm, R-London. 

"Both he and I shared the goal of getting these vape products off the market that were being geared toward our children," Raymer said at the Senate Judiciary Committee meeting held hours before it passed the Senate and won concurrence in the House. 

The bill passed the Senate 29-7-1 on Thursday, March 28. Sen. Karen Berg, D-Louisville, cast the "pass" vote. Voting no were Republicans Shelley Funke Frommeyer of Alexandria, Jimmy Higdon of Lebanon, Robby Mills of Henderson, Adrienne Southworth of Lawrenceburg and Stephen West of Paris, and Democrats Robin Webb of Grayson and David Yates of Louisville. 

The House agreed to the changes and sent the amended bill to Beshear on a 64-27 vote, ending a day of debate that began in the Senate Judiciary Committee.

Committee discussion

Raymer said HB 11 simply lines up Kentucky's law with what the FDA says is legal, noting that the majority of vaping products being confiscated in schools are flavored disposable products form China. 

"And they are illegal in China, and they're only being made for sale in the U.S.," she said, adding later, "We are not making anything illegal. We are simply following what the FDA has put in place." 

Troy LeBlanc, a retailer and manufacturer of vape products, spoke against the bill, stating  that it is "essentially creating a monopoly for Juul. It's one of the very few products that would be left." Juul is a Japanese company in which Altria Group, formerly Philip Morris Cos., owns a 35% stake.

"I  would have to close my stores, and closing my stores means I fire 50 people here in the state," LeBlanc asserted. "And we simply can't compete having vape stores have the exact same 15-20 products as every gas station," which he said are the biggest source of vapes for underage people. 

He said transcripts from an earnings calls with Altria show that if electronic cigarettes are restricted, the company's earnings per share will go up because they will sell more tobacco. "It's the reason why they're pushing this bill so hard," he said. Kentucky Lantern reports that Altria is pushing similar bills in other states. 

Greg Troutman, a lawyer for the Kentucky Smoke-Free Association, and LeBlanc urged the committee to hold the bill until January 2026 to give the U.S. Supreme Court time to review how the FDA regulates vaping products. "This bill is going to shut everybody down," said Troutman.

He added, "This bill is not going to keep them out of the hands of kids" because they will buy them online. "Do we want our kids ordering in bulk from China? . . . these are going to order them in bulk and take them to school and use them and sell them." 

Senate debate

Yates said he didn't think the bill would protect minors. He called for future bills to limit the sale of vape products in places that only serve those 21 and older and to put more money into enforcement. This bill, he said, will put "mom and pop" vape shops out of business. 

"Against the best efforts, we are creating a monopoly for one particular brand," he said. "We are getting rid of the other brands that even have lower nicotine products in them." 

Berg said castign a "pass" vote was difficult because she supports efforts to decrease underage vaping but there are issues with how the products are approved by the FDA and the exorbitant cost to get a product approved that have led to "only one product can be sold in the state."  

While voting "no," Funke Frommeyer called the bill "very disruptive to many small businesses in my Senate district. I need to stand up for them."
Sen. Reginald Thomas, D-Lexington, acknowledged the hardship for small vape shops, but said when it comes down to it he had to vote "yes" and vote "on the side of our young people and their health and their concern."

House debate

Rep. Savannah Maddox, R-Dry-Ridge, said she voted against the bill because it is already illegal to sell these products to minors. "What this is, is big government, nanny-state overreach," she said. "Today it's  these products; what is it tomorrow?" 

Rep. Richard White, R-Morehead, said he supported the bill because of the dangers these products pose to young people. He told a story of a 15-year-old who was on one of his church's vans who had to be taken to a hospital after he overdosed on a vape that someone gave him.

"These things are so unregulated and been brought in from places that are not legal," he said. "I urge everybody to vote yes to help protect our kids." 

Rep. Ken Upchurch, R-Monticello, said he has a son who will soon turn 15 that he worries about every day. He said he would be voting "yes" to protect him and "I don't care who gets put out of business."

In its final form, the bill was not a big hit with Kentucky Youth Advocates

“We had hoped to celebrate HB 11 as a win for kids this legislative session, but at this point, it looks as if adult special interests are winning the day,” KYA Executive Director Terry Brooks said in a press release

“What’s clear is that Kentucky’s kids are facing a vaping epidemic, orchestrated by ‘big vape’ companies through marketing and sweet flavors. What’s also clear is that kids are getting their hands on vapes through local retailers despite state and federal tobacco-21 laws prohibiting selling to those underage. What is unclear is why the Kentucky General Assembly continues to move the focus away from enforcing underage sales law and taking meaningful steps to reduce youth initiation of these addictive nicotine products.”

What's in the bill? 

The final version of the bill defined "authorized vapor product" to only include vapor products and added online retailers. It did not include the product directory from Storm's original bill, and it kept the stiffer penalties from Raymer's bill. 

Asked about the online sale of these products, Storm told reporters, "If you're an online retailer and you're going to do business in Kentucky, you need to make sure that your items are compliant. And if not, you're gonna be held accountable."

HB 11 would only allow FDA-approved vaping products to be sold in Kentucky, along with those that have received a "safe harbor certification" for products that fall under several qualifications, including those that remain under review, but has not yet been denied or approved for sale.

It would also require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state, who would send a list monthly to the Department of Alcoholic Beverage Control and the Department of Revenue. ABC, which is already responsible for enforcing laws aimed at limting youth smoking, would be responsible for creating a system that identifies and publishes the retailers who violate the law.

If the bill becomes law, it would fine retailers $100 to $500 for a first offense of selling vaping products to anyone under 21, which is consistent with existing law. The penalty for a second offense would be $1,000 and $5,000 for a third  or subsequent violation. A retailer with a fourth violation in two years would be banned from selling vapes. The bill also sets fines for manufacturers and wholesalers.

Friday, March 29, 2024

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.

Thursday, March 28, 2024

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.

Government Accountability Office says Medicare and Medicaid each overpaid health-care providers by about $50 billion in 2023

UPDATE, April 10: The Oversight Subcommittee of the House Energy and Commerce Committee will hold a hearing Tuesday, April 16, "to discusss ways how to better monitor the programs, reports Amy Lotven of Inside Health Policy.

Inside Health Policy chart; Government Accountability Office data
Improper payments, mainly through overpayments, in Medicare and Medicaid are expected to total about $50 billion each for 2023, the federal Government Accountability Office says in its annual report on the topic. Both programs showed declines in improper payments from 2022: $11 billion in Medicare and about $30 billion in Medicaid, the latter due mainly to "the end of states’ Covid-19 flexibilities, including the suspension of eligibility determinations and provider enrollment requirements," reports Amy Lotven of Inside Health Policy.

The GAO estimated total improper federal payments in 2023 would be $236 billion, but noted that the projections "do not include certain programs that have been determined susceptible to improper payments: for example, the Temporary Assistance for Needy Families programs; and the government-wide total potentially does not represent the full extent of improper payments," Lotven reports.

About $175 billion of the improper payments are overpayments, "while $44.6 billion were labeled 'unknown,' meaning GAO was unable to determine whether they were proper or improper," Lotven writes. "$11.5 billion were underpayments and $4.6 billion were technically improper because they failed to follow all applicable regulations even though the recipient was entitled to the funding."

While improper Medicare payments declined overall, they increased in Medicare Advantage, the privately run version of the prohram, whoch now serves most Medicare beneficiaries. GAO estimated improper Advantage payments at $17 billion in 2023, up from $12.8 billion in 2022.

"In addition to reporting on federal programs with $5 billion or more in improper payments . . . the report also lists the 16 programs that have improper pay rates of 10 percent or more," Lotven notes. The refundable premium tax credits under the Affordable Care Act and the Children’s Health Insurance Program had rates of 26% and 12.8%, respectively; in dollars, they were $958 million and $2.1 billion.

Tuesday, March 26, 2024

Four-part series from PBS and KET tells the story of public health

To play the trailer for the series, click on the arrow button.
Kentucky Health News

"Public health saved your life today and you don't even know it."

That's the catchphrase of a PBS series that began on KET Tuesday night, about the history of public health and how it has extended Americans' life expectancy by 25 years in the last century with vaccinations, clean water, prenatal care, school lunches, restaurant inspections, workplace safety, and other measures that usually don't have high visibility but have become a key element of modern life.

That increased life expectancy "is the most impressive thing that we have ever done as a species," says Dr. Joshua Sharfstein, distinguished professor of practice at the Johns Hopkins Bloomberg School of Public Health in Baltimore and the main narrator of the four-part series, called "The Invisible Shield."

In recent decades, many Americans have taken public health for granted and have shifted from the idea that they should cooperate for health as members of a society to the notion that health decisions are a matter of choice for individuals and families. Experts say that resistance to vaccination, as well as obesity, drug overdoses and suicides, has led to U.S. life expectancy declining for the first time in a century, even before the pandemic, to the point that it is about four years less than other advanced countries. They also point to the fact that public health isn't a priority for government funding unless there is an emergency, like the Covid-19 pandemic, which plays a major role in the first episode.

Public health "is underfunded, undervalued and misunderstood putting our health at risk," the series website says. The site has a discussion guide, which says "The work of public health is made visible by public health emergencies (pandemics, outbreaks, etc.), when society depends on the expertise of people who previously were working in the background. This docuseries also highlights the role of public health professionals as the first line of defense during public health crises through their use of outbreak science, health patterns, and forecasting data. It surfaces the challenges in educating the public about the public health system. It hopes to encourage viewers to learn more about the various roles and jobs that exist in public health and to be a part of the invisible shield in the future."

The next episode of the series will premiere on KET at 10 p.m. Tuesday, April 9, but can be seen now on the KET website. The last two do not have airdates scheduled. KET says it plans to air the series on KET2, when all episodes are made available. Episodes can also be watched on the PBS website.

Monday, March 25, 2024

Legislature sends Beshear bill decriminalizing medical mistakes; some in vitro fertilization advocates say bill will protect it

By Sarah Ladd
Kentucky Lantern

A bill giving Kentucky’s health-care providers criminal immunity for medical mistakes — which one lawmaker thinks will enshrine protections for in vitro fertilization by default — is on its way to Gov. Andy Beshear’s desk.

House Bill 159, which would decriminalize medical mistakes made by health care providers, passed the House in February by a vote of 94-0. On Friday it cleared the Senate — also without dissent.

The bill follows a 2022 Tennessee case in which a nurse was found guilty after a patient died from a medical mistake. The conviction led to protests and resignations within the health care community, KFF Health News has reported.

The Kentucky Nurses Association says that if medical mistakes are criminalized, providers are less likely to report them.

“I’m all for responsibility for medical errors,” said Sen. Phillip Wheeler, R-Pikeville, who carried the bill to the Senate floor on the 54th day of the 60-day legislative session. “I think that that is an appropriate domain for civil justice and not for the criminal justice system.”

State Sen. Whitney Westerfield
Republican Sen. Whitney Westerfield, who in February filed a bill seeking to protect access to in vitro fertilization in Kentucky, said he believes HB 159 will accomplish his goal by default. His colleague, Sen. Cassie Chambers Armstrong, D-Louisville, filed a similar bill to protect IVF.

“Neither of our bills have advanced,” Westerfield said while voting in favor of HB 159, which he said will cover IVF access because of its “broad” definition of the word “providers.”

The criminal-liability bill, sponsored by Rep. Patrick Flannery, R-Olive Hill, protects “a person providing health services” who is appropriately licensed and/or certified.

Bills to protect access to IVF, which is used to treat infertility and can help other people trying to get pregnant to do so, came this session in response to a ruling from the Alabama Supreme Court stating that frozen embryos are children.

The ruling led to concerns that it could deter people in Alabama from attempting to conceive children via IVF, which sometimes involves freezing embryos for future attempts at insemination. Several clinics in Alabama, including the University of Alabama Birmingham, paused IVF treatments and embryo transfers in response to the ruling.

Westerfield, of Christian County, said House Bill 159 will protect IVF.

“I think this bill accomplishes that and does so without necessary amendments or changes,” Westerfield said. “And so as a proud father of now four IVF children, I’m proud to see this bill make final passage and head to the governor.”

Sunday, March 24, 2024

Health insurers again win lobbying battle with doctors and hospitals over prior authorization of procedures, treatments

By Melissa Patrick
Kentucky Health News

A bill to exempt health-care providers who have 90% or more of their claims approved from health-insurance companies' requirements for prior authorization of ceratin treatments has failed again. 

"Unfortunately House Bill 317 looks like it's dead," said its sponsor, state Rep. Kim Moser. "We tried in good faith to work out a compromise and we did not have the same reciprocation. And so, you know,  I'm not exactly sure why it didn't get a hearing." 

HB 317 was placed in House Banking and Insurance Committee and had two of its three required readings to be heard on the House floor, but it was never called up for a hearing. The last regular day for final passage of a bill is Thursday, March 28.

Moser said her bill is important because it would ensure timely treatment and care that has been prescribed by a person's health care provider. 

Rep. Kim Moser
"It's really about making sure that patients get the care that they need when they need it," she said. "I think that there is a way to find a process that expedites the care that patients can get – and this is it." 

Asked what concessions she had made with the insurance companies, Moser said, "We removed Medicaid, which was huge." 

That only left the 450,000 patients on the state-regulated plans, which would have provided a snapshot of whether the change would work, she said. 

"We weren't calling it a pilot, but you know, it would allow us to really look at how this helped, or if it didn't help at all," she said. " And, you know, that's all we wanted was to be able to see how it works and see if this is a process that, like I said, (would) expedite the care that patients can receive." 

Physicians say the system undermines their medical judgement, and increases their administrative costs. 

“The current prior authorization process leads to delays for patients, administrative burdens for physicians, and increased costs,” KMA President Dr. Michael Kuduk said in a Feb. 21 news release.  “It’s time for us to pass a common-sense solution that doesn’t harm our patients or overburden our healthcare system.”

Allowing exemptions based on past performance has been dubbed a "gold carding program." KFF Health News reported Feb. 12 that five states have passed some form of it: Louisiana, Michigan, Texas, Vermont and West Virginia, and the American Medical Association is tracing active gold-carding bills in 13 states. 

Kentucky won't be one of them, at least this year, despite the strong lobbying efforts of the Kentucky Hospital Association and the Kentucky Medical Association. Moser said this is the third year she has worked on this effort. 

Asked about the bill's failure, Cory Meadows, KMA's deputy executive vice-president and director of advocacy, issued a statement saying the groiup "is extremely disappointed by HB 317's failure to pass during the 2024 legislative session. KMA members expressed the need for changing the prior-authorization process used by insurers that limits, and in some cases prevents necessary health care to Kentuckians. Throughout these past several months, citizens from around the commonwealth also shared their own stories of how the prior-authorization system impacted their lives, clearly showing that nearly everyone except insurance companies see the need to change this system.

"We're encouraged by the overwhelming bipartisan support the measure received and remain extremely optimistic that with continued advocacy from our members and the public, as well as collaboration with lawmakers, this critical legislation, which proposes to streamline the prior authorization process and ensure patients have timely access to care will soon be enacted. Otherwise, insurers will continue to pocket the money that could make Kentuckians healthier."

The hospital association also expressed its disappointment. 

"Prior authorization is a huge burden on physicians and nurses at our hospitals. And you know, it's contributing to burnout. And so we definitely support legislation that would minimize that burden, as many as has been passed in other states, and we would love to see a pass here," KHA President and CEO Nancy Galvagni told Kentucky Health News. 

Health insurers say prior authorization prevents unnecessary care and ensures that the care meets the standards of best practice. 

The Kentucky Association of Health Plans, the trade group for companies selling health insurance in Kentucky, issued a one-pager in opposition to HB 317 that said, "Prior authorization stops inappropriate care and procedures and heads off dangerous drug interactions and duplicative or inconsistent care, providing a whole-person approach to each plan member’s care needs. Plans help protect against predatory behavior."

Asked about the bill's demise, Tyler Glick, KAHP spokesman, issued this statement: "The health mandate statement generated by the Department of Insurance says the bill would cost up to an additional $11.29 in health-insurance premiums per member per month. That means a family of four would pay an additional $541.92 a year. How is saddling taxpayers (Medicaid), state employees and teachers (Kentucky Employees Health Plan), and everyone else in the commercial insurance market with these costs sound policy? Kentuckians deserve better."

Glick added, "KAHP will continue working with all members of the General Assembly to promote affordability, expose waste and fraud, and provide safeguards to patients."

Moser said she's not giving up on this effort and will likely work on it during the interim.

"The burdens of prior authorization are not going away anytime soon," said Galvagni. "And I'm sure the issue will be back. And, you know, we look forward to continuing to work on that."

Emergency-department visits and hospitalizations for respiratory illness keep dropping; at 'moderate' level for first time since fall

State Department for Public Health graphs, adapted by Kentucky Health News

By Melissa Patrick

Kentucky Health News

For the first time since December, the state Department for Public Health says both respiratory-virus activity and hospital admissions related to respiratory disease are moderate and declining in Kentucky. 

In the week ended March 16, emergency-department visits for influenza, Covid-19 and respiratory syncytial virus (RSV) dropped 30%, to 1,936. Of those visits, 1,555 were for flu. 

Hospital admissions for the diseases dropped 38%, to 272. Of those, 141 hospital admissions were for flu, 111 for Covid-19 and 20 were for RSV. 

In that same week, eight Kentucky counties had Covid-19 hospital admission rates between 10 and 19.9 admissions per 100,000 population, which the the Centers for Disease Control and Prevention considers to be a "medium" rate. Those counties were Clay, Elliott, Knox, Laurel, Menifee, Morgan, Rowan and Whitley. 

The state reported 1,761 laboratory-confirmed cases of the flu in the week ended March 16 and 1,121 lab-confirmed cases of Covid-19. These numbers have dropped for five weeks in a row. 

Since the flu season began in October, the state has recorded 439 Covid-19 deaths, 110 flu deaths and two co-infection deaths. One Covid-19 victim and one flu victim were children. 

State Senate weakens bill to curb underage vaping and sends it to the House with just days left in the legislative session

By Melissa Patrick
Kentucky Health News

A bill set up a regulatory framework to curb underage vaping passed out of the Senate on Thursday, March 21, but hasn't yet been assigned to a committee in the House, with only a few days left in the legislative session.

State Sen. Brandon Storm
Senate Bill 344, sponsored by Sen. Brandon Storm, R-London, passed 29-8-1 with a floor amendment that reduced the civil penalties in the original bill and made some technical changes. 

Storm said the goal of the bill is to clean up the illicit market in electronic vaping devices. He said it would require an e-vapor manufacturer to certify to the state that the products it sells comply with federal regulations. 

It would also require the state to publish a list of compliant products in a directory, which would allow manufacturers, distributors and retailers to know exactly which products could be sold in Kentucky. "Today, there is ambiguity," he said.

"This solution will improve how these products are distributed and sold and will reduce underage exposure and use while also providing adult smokers access to less harmful smoke free alternatives," said Storm.

The bill also includes a list of terms that couldn't be used to "advertise, distribute, market, offer for sale, or sell a vapor product," including "cake," "candy," "cupcake," "pastry," or "pie." It also states that any "advertising, design, marketing, packaging, or trade dress" cannot include a food or symbol that is marketed to minors, or be advertised on school supplies primarily used by minors. 

As amended, the bill would impose a civil penalty of $250 for each product offered for sale in violation of the rules until the product is removed from inventory or until the offending product is properly listed in the directory. The second violation at the same location within a 12-month period would be $500 per product. The third violation would be $1,000 per product and the fourth or subsequent violation would be $1,500 per product.

The original bill included an initial penalty of $500 per day, with a second violation in a year bringing a 14-day suspension of the store's business license. The third violation would have resulted in a 60-day suspension subsequent violations would result in a one-year suspension. 

Sen. David Yates, D-Louisville, said the way to decrease e-cigarette access to young people is to restrict their sales in convenience stores and to only put it in stores that allow people who are 21 and older. And, he said, it's imperative to have strong enforcement laws. 

"If you do have someone that's selling to children, we hit them with these monster fines and penalties that have been recommended and couldn't pass today. You shut them down. You hold them accountable," he said. "But instead, what we're going to do is we're going to protect a monopoly and ultimately allow tobacco sales to increase." 

Yates also noted that the U.S. Court of Appeals for the Fifth Circuit has ruled that the FDA process in approving which products can be sold is "arbitrary and capricious," and the case is going to the U.S. Supreme Court.

"So with our passage today, we know if anything, we're going to cost our taxpayers a whole lot of money in litigation," he said. "But let's do that, because we're being lobbied by a very, very strong group." 

According to the 2021 Youth Behavioral Risk Factor Surveillance System data, 45% of Kentucky's high-school students said they had used an electronic vapor product, 22% were current users, 8% were frequent users, and 7% used the products daily. Asked how they got them, 12% said they usually bought them at a convenience store, supermarket, discount store or gas station.

Among Kentucky middle-school students, 24% said they had used an electronic vapor product, 11% said they were current users, nearly 3% said they were frequent users, and 2% said they used the products daily.

A floor amendment filed by Sen. Jimmy Higdon, R-Lebanon, that would have required retail establishments that sell vapor products to be licensed and much more stringent penalties for violations, among other things, was withdrawn. Higdon said he didn't have the votes to pass it. 

A floor amendment filed by Sen. Adrienne Southworth, R-Lawrenceburg, failed to pass. It would have exempted from the "vapor products" definition those with 20 milligrams of nicotine per milliliter or less and those used in an open vaping system.

A bill similar to SB 344, House Bill 11, passed the House on March 11 and has been assigned to the Senate Licensing and Occupations Committee, but has not yet been heard.

The legislature, which can meet for only 60 days, must finish by April 15, unless the governor calls a special session. This session has six days left: Monday through Thursday of this week for passage of bills, followed by a recess during which the governor can sign or veto bills, then two days for legislators to reconsider vetoed bills. Those days are Friday, April 12, and Monday, April 14.

Saturday, March 23, 2024

'Momnibus' bill nears passage with change to require hospitals, birthing centers and midwives to offer perinatal palliative care

By Melissa Patrick
Kentucky Health News

A House-approved bill aimed at reducing maternal-mortality rates in Kentucky was approved without dissent by the Senate Health Services Committee on March 22 and sent to the Senate on the consent calendar, reserved for bills that are passed without debate.

State Rep. Kim Moser
"Kentucky has the ranking as second in the nation in maternal deaths in the year following childbirth," said the bill's sponsor, Rep. Kim Moser, R-Taylor Mill. "For this reason, we really started looking at some of the most significant problems and how to solve them."

Moser's House Bill 10 passed the House without disssent on March 5 and awaits a vote on the Senate floor with only six days left on the legislative calendar. 

The "Momnibus" bill would expand the Health Access Nurturing Development Services (HANDS) program and would allow the home-visitation program to be available up to three years after a child’s birth. It also would cover lactation consultation and needed equipment to encourage breastfeeding, and would educate mothers on the benefits of safe sleep for infants. These services would also be available via telehealth.

The bill would also ensure access to insurance coverage for pregnant women by adding pregnancy to the list of reasons a person would qualify for enrollment outside the normal open-enrollement period. This provision aims to help pregnant women address issues like obesity, diabetes and heart disease, all of which can cause complications and even death in pregnancy. 

"Deaths due to any of these factors are usually preventable," Moser said.

The bill would also address mental-health care by establishing a hotline for providers to get an immediate consultation for a mother in need of mental-health services. The hotline would be called Lifeline for Moms. It also aims to strengthen addiction services for those in need. 

"Our substance-use problem is one of the most significant issues," said Moser, noting that 53% of mothers who die in the year after childbirth "die from their substance abuse problem." 

The bill also has a provision to study doula programs and their benefit to those most at risk of poor maternal outcomes. Doulas provide moral, physical or other support in pregnancy, delivery and the postpartum period. 

What's in the committee substitute? 

The Senate committee substitute for the bill added language to require all hospitals, birthing centers and midwives to "provide or make referrals to a perinatal palliative care program, or perinatal palliative care support services" when there is a "prenatal diagnosis indicating that a baby may die before or after birth, diagnosis of fetal anomalies where the likelihood of long-term survival is uncertain or minimal or (the) newborn is diagnosed with a potentially life-limiting illness." The bill would also require this service to be covered by insurance. 

This addition comes from language in House Bill 467, sponsored by Rep. Nancy Tate, R-Brandenburg. It is titled the "Love Them Both Part II Act." Alex Acquisto of the Lexington Herald-Leader expands on the tension caused by HB 467 saying it is intended to offer "alternatives to pregnancy termination." 

Acquisto reports that "termination is one of the handful of options considered the standard of care health care providers present to patients with nonviable pregnancies," but with abortion illegal in Kentucky, this is not an option unless they go to another state for those services. 

Further, health care providers have told the Herald-Leader that such services already exist in hospitals across the state, thought not always in a formalized program.

HB 467 cleared the House Health Services Committee , which Moser chairs, on March 7. At that time, Kentucky Health News asked Moser, who is a primary co-sponsor of the bill, if she anticipated a greater need for perinatal palliative care since the state no longer allows abortions for nonviable pregnancies if there is cardiac activity present.

"I don't know that we're going to see a sudden uptick, but we just want to be available to moms and families," she said, adding later, "The intent is to provide support to a family who is dealing with a devastating diagnosis." 

The substitute bill would also require Safe Haven Baby Boxes to be staffed continuously by a licensed emergency-medical-services provider except when personnel are temporarily off-site providing emergency medical services. It also would require every public school to prominently display the Safe Haven Baby Boxes Crisis Line. This  language comes from House Bill 272, also sponsored by Tate.

Bill to let pharmacists give vaccines to children 5 and older heads to governor's desk; 11 Senate Republicans vote against it

By Melissa Patrick
Kentucky Health News

A bill to allow Kentucky pharmacists to order and administer vaccinations to children down to the age of 5 has gained final passage, but only after several senators voiced their concerns about the bill and four of them changed their votes from "yes" to "no."

Since 2017, Kentucky pharmacists have been able to administer vaccinations to children as young as 9, and younger with an order from a health-care provider. The age was lowered to 3 during the Covid-19 public health emergency to help increase access to care, but that law is set to expire Oct. 1.

The original version of Rep. Danny Bentley's House Bill 274 would have allowed pharmacists to order and administer vaccinations to children as young as 3, with the consent of a parent or guardian, but this was increased to age 5 in a committee substitute to appease the Kentucky Medical Association.

State Sen. Stephen Meredith, R-Leitchfield
(Legislative photo from March 8, 2024) 
Sen. Stephen Meredith, who presented the bill to the Senate, lauded it as a way to "fix a problem," noting that Kentucky ranks lower than five of the seven surrounding states when it comes to childhood vaccinations.

"Kentucky is facing a public-health crisis in regard to childhood vaccinations," the Leitchfield Republican said. "It does not introduce any new vaccine mandates. It does not expand the scope of practice of pharmacy. It does not replace well-child checkups."

The Senate gave final passage to HB 274 on a vote of 26-11 on March 22. It will now go to Democratic Gov. Andy Beshear's desk for his signature or veto. 

Sen. Lindsey Tichenor, R-Smithfield, withdrew two floor amendments that she had filed, one to ban requiring students to get the Covid-19 vaccine for "enrollment, employment or medical treatment" and the other to require employers to offer religious or medical exemptions for vaccinations to all employees. 

(On the same day, Tichenor's Senate Bill 295, to prohibit the requirement of a Covid-19 vaccine for any individual for the purposes of student enrollment, participation in any school-based program or extracurricular activity, internship, acquiring or maintaining a professional license or receiving a health care services, was approved with a committee substitute by the Senate Health Services Committee on a vote of 8-2.)

The bill Meredith carried, HB 274, passing the House without dissent on March 5, ran into opposition in the Senate.

Sen. Adrienne Southworth, R-Lawrenceburg, voted no and said she was "baffled" about the discussion, arguing that there is no longer a need for pharmacists to administer vaccines to younger children because the public-health emergency is over.

"I know our pharmacists have been administering vaccines, when we're in a state of emergency," she said. " And we're done with emergencies. . . . Are pharmacists dispensing drugs or are they administering vaccines?"

Tichenor also voted no, voicing concerns that the bill allows pharmacists to give vaccines to a child without knowing their medical history: "I think it's a little bit reckless to be issuing out vaccines that do have potentials for bad adverse events, and to be opening a door where it can be easy or easier, more accessible with less oversight." 

Sen. Shelley Funke Frommeyer, R-Alexandria, questioned the safety of the additives in vaccines: "We are continuing to promote and advocate something that isn't actually [in] your control. It's now in the doctor's or the pharmacists," she said. "We must own our health. We must be committed to our children's health." 

Meredith lambasted his colleagues who voted against the bill, speaking to the challenges that people in rural Kentucky have when it comes to getting access to care. 

“It’s easy to assume that people have access to care, particularly rural Kentucky. It’s not there," he said. "What do they do if they don’t have it? . . . That’s very easy to say, ‘Just get in your car and drive a few miles up the road.’ If you think that way, then you don’t really understand rural Kentucky."

Meredith added, “If you’re voting against this based on principle, you’re cheating the children of Kentucky, particularly rural Kentucky. I can’t begin to tell you how disappointed I am in that.”

Other Republican senators voting against the bill were Floor Leader Damon Thayer of Georgetown, Tichenor, Johnnie Turner of Harlan, Stephen West of Paris and Gex Williams of Verona. Changing their vote from "yes" to "no" were Republicans Robby Mills of Henderson, John Schickel of Union, Brandon Smith of Hazard and Phillip Wheeler of Pikeville. 

Kentucky kids still playing vaccine catch-up

Access to routine vaccinations remains crucial, especially among kindergarteners, a group whose routine vaccinations seem to have been hit hardest by the pandemic.

In November, Kentucky Health News reported that uptake of the combined measles-mumps-rubella vaccine in the state increased in 2023, after three years of decline, but the remains below the national average and the level needed to protect the population from measles, a highly contagious disease that has cropped up in several states.

Most of the routine childhood vaccine rates for kindergarteners remain below pre-pandemic levels, according to the state Department for Public Health Kindergarten Immunizations Dashboard.

The Centers for Disease Control and Prevention offers a wealth of information about the safety of vaccinations and the American Academy of Pediatrics calls for the on-time, routine immunization of all children and adolescents "as the safest and most cost-effective way of preventing disease, disability and death," it says.
Kentucky's schools require students to provide up-to-date immunization records at the beginning of each school year, unless a student is exempted for religious or medical reasons.

Bill targeting certificate-of-need process for health-care facilities gets only three votes in House Health Services Committee

State Rep. Marianne Proctor (KL photo by Sarah Ladd)
By Sarah Ladd
Kentucky Lantern

A bill that opponents said would effectively repeal Kentucky’s certificate-of-need law for health-care facilities failed in a strong bipartisan vote of the House Health Services Committee Thursday.

House Bill 204 would have blocked the ability of a dominant provider to sue a certificate-of-need applicant during the process. It failed as 13 committee members voted no, three voted yes and two lawmakers passed.

Both Republicans and Democrats voiced concern that the bill was premature and would place rural hospitals at risk.

The sponsor, Rep. Marianne Proctor, R-Union (Boone County), told legislators that her goal is to open the state to investment by health-care providers.

“This bill does not change any of the process of certificate of need. You still must demonstrate that there is a need and you still must go through this nine-step process,” she said. “What this bill does is just eliminates the dominant provider’s ability to sue you at step three and step nine.”
Speaking in favor of the bill, Heather Lemire, the Kentucky director at Americans for Prosperity, said the process to get a certificate of need in Kentucky is “a very flawed system.”

The requirement mandates regulatory mechanisms for approving major capital expenditures and projects for certain health-care facilities. Such laws were in effect in 35 states and Washington, D.C., as of December 2021, according to the National Conferemce of State Legislatures.

“This [bill] does not address repealing certificate of need,” said Lemire. “But this would at least make it a fair playing ground for people who are wanting to go through the process.”

Among those who testified against the bill, Northern Kentucky lawyer Mark Guilfoyle, who represents St. Elizabeth Healthcare, said Proctor’s proposal “really makes a mockery of the CON process.”

Instead of making a small change to the law, Guilfoyle said the bill would “effectively repeal CON in Kentucky.”

Nancy Galvagni, president of the Kentucky Hospital Association, agreed. The bill “effectively nullifies” the process, she said.

“House Bill 204 makes the certificate-of-need process just another licensing process,” she said. “Communities that are affected by a certificate-of-need application will be denied any process to question or challenge a certificate-of-need application.”

The KHA pitched several reforms to the process last year, and seeks continued study of the issue. A task force met over the interim to study it, and concluded that it needed more study. A resolution was introduced this session to reestablish the task force.

The bill “sidesteps the task force’s recommendations,” Galvagni said.

What do lawmakers think?

Rep. Josh Bray, R- Mount Vernon, echoed concerns expressed in the interim that without certificate of need, new businesses could “cherry pick” profitable services and hurt hospitals in rural areas that lack sufficient population to support multiple facilities.

“While I support the idea of a free market, and at its core, the idea of a free market in health care … sounds great, but the bottom line is, in my part of the state, in rural Kentucky, we don’t have free-market health care. We’re heavily dependent on Medicaid reimbursement rates.”

Getting a certificate of need is “burdensome” and “extremely cost prohibitive,” Bray said, and needs modernization, but he worries this bill could harm rural hospitals.

“It terrifies me that my hospital back home would have to start looking at reducing services they offer in order to be accommodated by another group coming in and cherry-picking services,” said Bray, who later voted against the bill.

Rep. Lindsey Burke, D-Lexington, also voted against HB 204.

“Most of the legislators who I’ve spoken to do have an appetite for reform and I believe that the medical institutions also have an appetite for reform,” Burke said. “I know that the task force can do more research, bring more experts, and we can come up with better solutions than what’s been proposed here.”

Friday, March 22, 2024

Appeals court upholds proposed warning labels for cigarette packs, but sends case back down to decide a procedural issue

Three of the proposed warning labels for cigarette packs and ads
By Kevin McGill
Associated Press

A federal rule to require cigarette packs and advertising to include graphic illustrations that demonstrate the effects of smoking — including pictures of smoke-damaged lungs and feet blackened by diminished blood flow — does not violate the First Amendment, an appeals court ruled Thursday.

The ruling from a three-judge panel of the 5th U.S. Circuit Court of Appeals was a partial victory for federal regulators seeking to toughen warning labels. But the court kept alive a tobacco-industry challenge of the rule, saying a lower court should review whether it was adopted in accordance with the federal Administrative Procedure Act, which governs the development of regulations.

The appeals-court panel rejected industry arguments that the rule violates free speech rights or that it requires images and lettering that take up so much space that they overcome branding and messaging on packages and advertisements.

The ruling overturns a lower court order from a federal district court in Texas, where a judge found that the requirements did violate the First Amendment.

“We disagree,” Judge Jerry Smith wrote for the 5th Circuit panel. “The warnings are both factual and uncontroversial.”

In addition to Smith, who was nominated to the court by former President Ronald Reagan, the panel included judges Jennifer Walker Elrod, nominated by George W. Bush, and James Graves, nominated by Barack Obama.

While reversing the lower court's key finding, the panel noted that the judge had not ruled on the Administrative Procedures Act question. It sent the case back to the district court to consider that issue.

The images in question include a picture of a woman with a large growth on her neck and the caption “WARNING: Smoking causes head and neck cancer.” Another shows a man’s chest with a long scar from surgery and a different warning: “Smoking can cause heart disease and strokes by clogging arteries.”

Nearly 120 countries have adopted larger, graphic warning labels. Studies from those countries suggest the image-based labels are more effective than text warnings at publicizing smoking risks and encouraging smokers to quit. About 23% of Kentuckians smoke, the second highest rate in the nation.

UK diabetes research featured in group's annual research report

Brittany Smalls, Ph.D., is at upper right.
By Hilary Smith
University of Kentucky

One of the cover stories in the annual reserach report from the American Diabetes Association is about a University of Kentucky researcher devoted to helping rural Kentuckians — specifically in Appalachia — better manage their diabetes.

highlighting investments in advancing diabetes research and clinical practice. ADA research grants focus on innovative projects with high impact and help researchers establish collaborative networks to move their innovations into the hands of people living with diabetes.

Brittany Smalls an associate professor and the Dr. Claire Louise Caudill Professor in Family Medicine in the UK’s Department of Family and Community Medicine. Her futire work in Appalachia will look at intergenerational households, where large extended families often live together in the same home or throughout shared pieces of land. These families share everything from living spaces, meals, household chores, caregiving and more.

Such househodls are common in Appalachia, and so is a disproportionately high risk for Type 2 diabetes. The prevalence of Type 2 diabetes reaches 23% in Kentucky’s most rural counties, more than twice the state average.

Throughout her career of helping older adults with type 2 diabetes, Smalls quickly noticed that the adult children and grandchildren of those she worked with could also benefit from her research.

Thanks to an award from the ADA, Smalls will expand her focus from older adults with type 2 diabetes to entire families living with or who are at risk for the disease.

“By tapping into tight-knit family units, we can start to shift how people think about their health and how they think about each other,” Smalls said.

The cover story from the ADA’s report details Smalls’ work resulting from the award:

“She is piloting a health intervention that leverages social support within family units to promote nutrition and physical activity, which are key to mitigating obesity and type 2 diabetes. Each participating family will receive a tailored six-month lifestyle plan. 

“Only one adult needs a type 2 diabetes diagnosis for a household to be eligible, and a dietitian will engage them in medical nutrition therapy based on available foods. Participating families will receive ADA-backed recommendations for physical activity based on family members’ physical ability.”

Wednesday, March 20, 2024

UK wants your ticks: dead, dry and properly packaged

Getty Images via UK
By Jordan Strickler
University of Kentucky

The Kentucky Tick Surveillance Project is now accepting tick-testing submissions from Kentucky residents. This project, produced by the University of Kentucky Martin-Gatton College of Agriculture, Food and Environment, aims to improve knowledge about where ticks are found and the diseases they might carry.

The results help further public health research at the state level and alleviate concerns for citizens worried about tick-borne illnesses.

To ensure the safety and integrity of the samples, and to comply with postal regulations, participants are urged to follow strict guidelines when preparing ticks for submission:
  • Do not mail live ticks: Ensure that ticks are not alive when sent.
  • Avoid liquid alcohol: Do not send samples in containers of liquid rubbing alcohol.
  • Proper packaging: Avoid using only paper envelopes for mailing ticks as they may get damaged in mail processing machines.
  • Avoid taping ticks: Do not place ticks between pieces of tape.
Participants must complete a submission form before sending their tick sample. This form is crucial for processing and can be found at Samples without a completed form will not be accepted. Detailed instructions for preparing the tick sample, including necessary supplies and packaging steps, ensure samples arrive in good condition for testing.

Important Considerations:
  • Selective Testing: Ticks will not be tested for all possible pathogens. The project focuses on gathering data for surveillance purposes.
  • Notification Process: Submitters will only be contacted if their submissions test positive for pathogens. There will be no notification of negative results.
  • Backlog and Time: Due to the project's volunteer nature, there is a testing backlog. Participants should expect delays.
  • Not a Substitute for Medical Care: If a tick has bitten you and has symptoms, seek immediate medical attention. Do not rely solely on submitting the tick for health decisions.
"Community involvement is the backbone of the Kentucky Tick Surveillance Project," Larson said. "Every tick submitted is a piece of the puzzle in understanding our state's tickborne disease landscape. We thank everyone who participates for their contribution to this important work."

Please send all ticks to: Tick Surveillance Program, c/o Subba Palli, Department of Entomology,
S-225 Ag Science Center North, Lexington KY 40546-0091.

For more information, visit

Tuesday, March 19, 2024

UK research reveals way to improve treatment for breast cancer

By Elizabeth Chapin
University of Kentucky

A recently study at UK's Markey Cancer Center uncovered a critical pathway involved in evasion of the immune system by breast-cancer cells, pointing the way to make chemotherapy for the disease more effective.

A study by UK Markey researcher Yadi Wu reveals a
potential pathway for breast-cancer drug development.
(Photo by Ben Corwin, UK Research Communications)
The study, led by Markey researcher Yadi Wu, addresses a crucial gap in the understanding of how breast cancer fosters immune evasion and offers a new potential target for cancer therapies.

The research suggests a chain reaction between three proteins helps breast-cancer cells evade the immune system. By disrupting this chain, researchers made the cells more susceptible to immunotherapy.

"The results suggest targeting this pathway in the development of cancer therapies," said Wu, an associate professor in the Department of Pharmacology and Nutritional Sciences. "This new knowledge could potentially lead to more effective breast cancer treatments for patients."

Cancer cells can avoid immune detection by manipulating genetic signals. One such way is through LSD1, a protein involved in regulating gene expression. High levels of LSD1 are found in many cancers and are linked to worse outcomes for patients. Studies show that blocking LSD1 can help immune cells fight cancer more effectively.

The lab study on breast-cancer cells revealed that CDK9, another protein involved in regulating gene expression, plays a crucial role in stabilizing LSD1 and therefore causing immune suppression. This stabilization is achieved through a process involving the third protein, RNF20.

When researchers disrupted this interplay by removing RNF20, breast cancer cells became sensitized to a type of immunotherapy treatment called anti-PD-1.

"This discovery is a significant step forward in our understanding of how cancer cells evade the immune system," said Wu. "Our findings highlight the potential importance of targeting the CDK9-RNF20-LSD1 pathway in the development of new cancer therapies, specifically immunotherapies."

The study was published the Proceedings of the National Academy of Sciences

Sunday, March 17, 2024

Bill to protect independent pharmacies from benefit managers moves after changes; insurers say it would increase premiums

By Melissa Patrick
Kentucky Health News

A bill to set new controls on commercial pharmacy-benefit managers was approved by a Senate committee on March 14 as a measure scheduled to be approved without debate by the full Senate. 

State Sen. Max Wise
The bill's sponsor, Sen. Max Wise, a Republican from Campbellsville, has worked on PBM reform for years. In the 2020 legislative session he won passage of a bill that required the state to hire a single PBM for the state's Medicaid program, resulting in savings of $282 million. 

That said, while thanking everyone who worked on the bill, both for and against it, Wise told the committee that his latest "may be the hardest one that I have worked on yet during my time in this particular legislature." 

Wise walked the Senate Banking and Insurance Committee through a substiute version of Senate Bill 188, with several changes from the original.

He said the original would have prevented a PBM from requiring Kentuckians to receive their prescriptions by mail, from reimbursing a pharmacy that they own at a higher rate than a community pharmacy, stop the steering of patients to pharmacies owned by the PBM. It also would have allowed community pharmacies to fill 90-day prescriptions for maintenance drugs, prohibited higher co-pays at community pharmacies compared to PBM-owned pharmacies, and  protected  community pharmacies from retaliation for providing cost-saving information to patients. 

Wise added that the original bill would have provided a fair dispensing fee, and mandated that PBMs pay pharmacies at least the cost of the dispensed drugs, provided a fair dispensing fee and include community pharmacies in their networks to offer patients the flexibility to choose a nearby pharmacy. 

He then walked through the changes made by the committee substitute. 

He said it excludes prescription drug plans established under Medicare Part D from the legislation regarding self-funded health plans or Employee Retirement Income Security Act (ERISA) plans. 

He said both the original bill and the committee substitute include the phrase "to the extent permitted under federal law" before several sections in the bill.

"The reason for that is the United States Supreme Court in its Rutledge decision greatly limits what authority states have to regulate ERISA plans," he said. "The inclusion of the phrase mentioned means that most of the provisions of Senate Bill 188 will not apply to ERISA plans; it is likely that only the fair dispensing rate will apply." 

Addressing concerns about imposing the Kentucky Medicaid dispensing rate of $10.64 per prescription on the commercial marketplace, Wise said the substitute addresses this in two ways.

First, he said, instead of using that rate as the dispensing fee floor, the state Department of Insurance would conduct a survey of dispensing costs at both large chain pharmacies and small independent pharmacies. While the DOI is completing the survey, Wise said, the Medicaid dispensing rate will be used as a "gap-fill payment floor."

And unlike the original bill, the protection of the Medicaid fee would only be available to independent community pharmacies as licensed by the state Board of Pharmacy and would not be available to chain pharmacies. 

"So why is it important that we include this gap payment for community pharmacies?" Wise asked. "In the last two years over 68 independent pharmacies have either closed their doors or sold out to chain pharmacies [in Kentucky] due to the massive decline in PBM reimbursements." 

The revised bill also removed, at the request of PBMs and insurance companies, provisions on "white bagging," a practice in which a medication must be prepared and distributed by a third-party specialty pharmacy, instead of allowing providers to prepare, administer and bill for the medication.

Wise added that a health-mandate statement estimates that the bill would raise helath-insurance premiums $1.89 to $25.01 per member per month. The range is wide and essentially unpredictable because there is a lack of reliable data regarding PBM contracts. 

Wise said legislators saw similar estimates when they passed his 2020 bill, but this did not come to pass, and "I feel confident that we will see, just like Tennessee and West Virginia have passed, to not see any increases" with commercial PBM reform, which those states have passed.

Sitting at the table with Wise was Ben Mudd, executive director of the Kentucky Pharmacists Association, and Rosemary Smith, co-founder of the Kentucky Independent Pharmacist Alliance. 

Opponents of the bill

Speaking against the bill were Conner Rose, senior director of state affairs for the Pharmaceutical Care Management Association, the national PBM lobby, and Hope McLaughlin, senior director of government relations for Elevance Health, which operates as Anthem Blue Cross Blue Shield in Kentucky.

Rose noted the high estimate of $25 increase in monthly premiums. "I understand that the purpose of this bill is to help independent pharmacies," Rose said. "But the solution we're talking about today falls on the backs of employers, city and county governments, their employees, the employees of employers in Kentucky, and ultimately individual consumers all across the commonwealth."

He added that the mandates and restrictions in the bill hinder the ability of employers and other plan sponsors to capitalize on the savings that PBMs provide, pointing to how generic drugs offered on the PBM formularies often don't have co-pays or dispensing fees if it comes through the PBMs mail service.  

McLaughlin stressed that the committee substitute was not a compromise and that while they appreciate the removal of the white-bagging provision, she said Anthem still has many concerns about it.  

She said the mandated dispensing fee of $10.64 per prescription "will result in significant, additional health-care costs," and also mentioned the "significant increase" of $25 per month.

And she said the bill "sets a dangerous precedent of putting the General Assembly and the Executive Branch in the role of setting provider reimbursement rates."

But the committee approved the bill without dissent and placed it on the Senate's consent calendar, reserved for bills that are passed on a singke vote without debate. It has 20 sponsors, a bare majority of the Senate.

Besides Wise, they are Republicans Stephen Meredith of Leitchfield, Matthew Deneen of Elizabethtown, Donald Douglas of Nicholasville, Greg Elkins of Winchester, Shelley Funke Frommeyer of Alexandria, Rick Girdler of Somerset, Jimmy Higdon of Lebanon, Jason Howell of Murray, Robby Mills of Henderson, Brandon Storm of London, Lindsey Tichenor of Smithfield, Stephen West of Paris, Phillip Wheeler of Pikeville and Mike Wilson of Bowling Green, and Democrats Karen Berg, Gerald Neal and David Yates of Louisville and Robin Webb of Grayson.