State and federal lawmakers say they're still trying to rein in health-insurance middlemen, called pharmacy-benefit managers

By Melissa Patrick
Kentucky Health News

A day after Gov. Andy Beshear talked at a White House roundtable about Kentucky's moving to one pharmacy-benefit manager for Medicaid, First District U.S. Rep. James Comer, spoke at another Washington event about his efforts to reform PBMs as chair of the House Committee on Oversight and Accountability.

U.S. Rep.  James Comer

“The focus of what PBMs' role should be, should be to help the consumer have more choice, have lower costs," Comer said at a March 7 event hosted by The Hill. "But what’s happening is the focus now with the PBMs is which drug can we make the most profit off of, regardless of what’s best for the patient. And I don't think that's a good business model." 

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

Earlier this year, Comer's committee passed with broad bipartisan support the Delinking Revenue from Unfair Gouging (DRUG) Act, which would rein in practices by some PBMs that offer health plans under federal employees' health program. 

Comer said PBM reform remains a priority, and his committee has received more than 40,000 pages of documents for a report that will be released "very soon." He said his panel will have another hearing once the report is release to discuss next steps.

He said those who understand the issue "realize that PBMs have actually added cost to the consumers" at a time when everyone recognizes that the rising cost of prescription drugs is not sustainable. 

Despite comgressional concern about the issue, the government-funding bills just signed by President Biden do not include PBM reforms. Asked if they coudl pass in the "lame duck" session after the November elections, Comer, using his own committee as an example, said, "I think something can always be done before." 

Comer said much of the problem comes from three major PBMs controlling 80% of the market, noting that they are owned by health-insurance companies and have their own mail-in pharmacies. 

“I believe PBMs have had a negative impact on competition, especially among community pharmacists,” he said. “I believe they have an unfair competitive advantage. I believe they’re doing a lot of things that are unethical at best and should be illegal at worst with respect to – I would even go as far as saying extorting fees from independent pharmacies. We’re losing independent pharmacies.”

Kentucky lawmakers have been working on PBM issues for years. Most recently, in 2020, they passed a bill sponsored by Sen. Max Wise of Campbellsville, a Comer ally, that required the state to hire a single PBM for the state's Medicaid program. Before this law, each of the six companies that manage Medicaid for the state had its own PBM.  

At the White House roundtable, Beshear talked about the legislation and how he began investigating PBMs' drug-pricing methods when he was attorney general in 2016-19.

“That single PBM that answered to us, and not to any other company, has allowed Kentucky Medicaid to maximize drug rebates and has saved our Kentucky families about $300 million since we've done it,” he said. “And it allowed us to understand more about how to get the right price.”

Kentucky PBM reform efforts are ongoing

Wise's latest PBM reform measure is Senate Bill 188, which involves PBM reform efforts on the commercial market.  

State Sen. Max Wise

“I’m optimistic this measure will yield similar savings by applying the same standards to the commercial market, effectively cutting costs for Kentuckians with private health insurance plans,” Wise said in a Feb. 8 news release about the bill.  

SB 188 "aims to empower citizens to choose where they purchase their medication, prevent further closures of community pharmacies and ensure fair reimbursement rates for these essential health care providers," said the release.  

SB 188 has been assigned to the Banking and Insurance Committee. It has not yet been heard or voted on in committee, but has received its first reading, an indication that it has a chance for passage. 

Another bill that addresses PBMs passed out of the House Health Services Committee on March 7. House Bill 190, sponsored by Rep. Scott Sharp, R-Ashland, was approved unanimously and was placed in the House for possioble action as early as Monday, March 11. 

State Rep. Scott Sharp

HB 190, as amended by a committee substitute, would allow people to receive their medication directly from the mail, but if it does not get there in time, they would have the option to purchase it from their local pharmacy at the same price it would cost if it was mailed to them.  

Sharp said he was prompted to file this bill because of a personal experience. 

He said he went to his local pharmacist to get a drug for a family member who was having some trouble getting it delivered. He said he was told it would cost $400, instead of the $36 it would cost if it came by mal. 

Upon talking to his PBM, he learned that this was the "penalty" for using his local pharmacy, instead of getting it mailed direct. Since, he said he's learned that this is a common problem and that's why he wants to "fix it." 

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Bill is moving to create database (but not licensing) of vape retailers, raise fines and bring state law in line with FDA rules

A customer vapes at a shop in Richmond, Va. (Associated Press file photo by Steve Helber)

By Melissa Patrick
Kentucky Health News

A bill to create a statewide database of retailers that sell vaping products, and align state law with federal restrictions on the products, is moving through the Kentucky General Assembly.

House Bill 11, sponsored by Republican Rep. Rebecca Raymer of Morgantown, was approved with a committee substitute by the House Health Services Committee on March 7 and was posted for possible action by the House starting Monday, March 11. 

After nearly an hour of discussion, HB 11 was approved 14-1-3, with Rep. Felicia Rabourn, R-Pendleton (Henry County), voting no and Democratic Reps. Adrielle Camuel of Lexington, Rachel Roarx of Louisville and Lindsey Burke of Lexington passing. 

Rep. Rebecca Raymer

Raymer said she began working on the bill after learning that most items confiscated in Kentucky schools are flavored and disposable vapes,and “I found out that these vapes are not even supposed to be offered for sale,” under rules of the U.S. Food and Drug Administration.

She said opponents would say that the bill will all such products off the shelf, but “That is simply not true. There are other states that have used the same definitions that we are using. I think Alabama is one of the states and they have about 1,600 products on their registry of things that can still be sold.”

Raymer said Congress is lobbying the FDA to create a concise list of what is legal and not legal, and “We are not the regulatory authority over these products. We don't get to decide what is legal and illegal.”

Dr. Britt Anderson, a pediatric emergency-medicine physician and vice-president of the Kentucky Chapter of the American Academy of Pediatrics, told the committee that she sees children come into emergency rooms addicted to nicotine and unable to stop vaping, which makes them cough and wheeze and be unable to exercise.

Vaping has become much more common among Kentucky schoolchildren than smoking. While the long-term effects of vaping on young people's health are unknown, Anderson said what we do know about vaping and nicotine use in youth is not "cutting-edge science." 

"We do know that they cause lung injury and changes to brain development during a crucial stage of life," she said. "And it's not just the nicotine. The complete ingredient list may contain fine particles and other carrier solvents that are unhealthy as well."

Mallory Jones, a junior at George Rogers Clark High School in Winchester, told the legislators that high schoolers can easily purchase vaping products despite the age restrictions.

"Once one person in a friend group starts using e-cigarettes, word gets around of where you can buy these products illegally, and it spreads like a domino effect," she said.

Jones lauded the bill, saying, "Addressing the source of these products is critical to reducing youth access and initiation of nicotine, but the rules are only as good as the enforcement that we put behind them."

Griffin Nemeth, coordinator of the #iCANendthetrend Youth Advisory Board at the University of Kentucky, noted that while HB 11 does not allow Kentucky to join the 40 other states that have some form of comprehensive tobacco retail licensure, it does allow the state to have a better understanding of the retail environment.

But he added that alone is not enough to make a difference: "It is with, and only with, the three combined elements of a retailer database, compliance checks and stiff penalties for violations that we can implement comprehensive prevention at the point of sale." 

Opponents of the bill

Troy LeBlanc, a retailer and manufacturer of vape products, said he supports efforts to decrease youth use of them, but said this bill won't do that because the bulk of the products approved by the FDA are sold in convenience stores and that's where most of the bad actors are when it comes to selling these products to youth.

"I urge you to change this bill to put these products in 21-and-over stores and have them policed by the ABC and have them fined with major fines . . . Make sure that the fine hurts enough to where people will not do it," he said. 

LeBlanc also said this bill would eliminate access to low-nicotine products while allowing sale of high-nicotine products made by large companies. 

He said the average nicotine level of products sold in vape shops is 3 milligrams per milliliter, while the large companies like Altria (formerly Philip Morris), make products with a much higher nicotine content.

"I don't believe it's the right bill because all it's going to do is to make sure that Altria is the main seller in every convenience store . . . . Juul is going to be all over the state," he said. "Juul also does not offer any nicotine product that's lower than 30 milligrams per milliliter." 

LeBlanc also pushed back on Raymer's claim that Alabama allows 1,600 products on their shelves, saying that after dissecting the list, "There are only eight brands on there of flavored nicotine." 

Mike Reichert of Campbell County, who said he owns two vape shops in Northern Kentucky, said this bill would likely cause his shops to close. 

"Most of the products that I sell would be banned as this bill is currently written," he said. "It would almost certainly cause my stores to close." 

Reichert said he got into the business to help people quit smoking, making that possible by selling the lower-nicotine products that can be tapered down to zero nicotine in his store. He agreed with LeBlanc that sales should be limited to 21-and-older stores, with higher fines to keep the bad actors out. 

Tommy Wilson of Pulaski County, who said he owns two vape stores, also pushed for such a move, which he said would likely make this issue go away. 

Wilson said he had helped thousands of people get off nicotine via combustible cigarettes and move to a lower-dose vaping product. 

“We too don't want youth vaping," he said. "But that said, we feel like it’s an adult’s choice to be able to find something that they deem is less harmful to their body. . . . Is it perfect? Maybe not, but is it better than 3,000 chemicals and burning smoke going into your lungs? I feel it is." 

The committee chair, Rep. Kim Moser, R-Taylor Mill, asked the opponents of HB 11 to keep talking to the bill sponsor to see if any tweaks can be made. 

"No one wants to do anything that is going to put anyone out of business," she said. "That's not our goal." 

Legislators' concerns

Rep. Josh Bray, R-Mount Vernon, asked the vape-shop owners if they're selling products that are not FDA-approved, prompting them to walk through the history of vaping products in the U.S., the ongoing methodology challenges to get products approved by the FDA and the legal challenges surrounding this issue. 

Earlier in her remarks, Raymer noted that she understands that those in opposition of this bill don't like the FDA process for regulating these products, but the bottom line is that the FDA has that authority. 

"And so we, as a state, have an obligation to offer some protection to our citizens," she said. "If we know these products are not authorized, they are not legal per the FDA, we shouldn't have them."

Roarx, one of the Louisville Democrats, said she appreciates the bill’s goal to keep Kentucky youth away from nicotine products, but said she has concerns that the bill might have unintended consequences on the tobacco and e-cigarette industry by creating a monopoly.

“I hope we can continue to make progress to make sure that we’re not just giving a couple of brands a monopoly on the entire industry,” Roarx said. 

The bill would take effect Jan. 1, 2025. Among other things, it would:

• limit the sale of products to those authorized by the FDA and would punish retailers who sell unauthorized products to anyone under 21 years of age;
• require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state;
• require the secretary of state to create a list of the businesses and share it monthly with the ABC and the state Department of Revenue;
• require the ABC to create and maintain a tobacco database and reporting system, to be published monthly;
• set rules around how manufacturers, wholesalers and retailers sell and distribute the products;
• establish fines for manufacturers, wholesalers and retailers for noncompliance; and
• allow police officers and ABC investigators to issue a uniform citation for any violation of the law. The citations would then be reported to and enforced by the ABC.

What are the fines? 

The bill would require any manufacturer of products covered by the federal Tobacco Control Act to sell authorized products to wholesalers and retailers. A manufacturer that violates this section would be subject to a fine of $25,000 for a first violation, $50,000 for a second violation and $75,000 for third and subsequent violations.

It would ban a wholesaler from selling unauthorized products and from selling authorized products to a retailer until it verifies that the retailer is not in the tobacco non-compliance database and reporting system. Violators would be subject to a $5,000 fine for the first violation, and $15,000 for the second and subsequent violations.

The bill would ban retailers from selling unauthorized products to any person, and set fines of $1,000 for the first violation, $5,000 for the second violation, and loss of "the ability to sell Tobacco Control Act covered products for one year" for a third violation. A banned retailer who had another violation would be fined $10,000 per transaction.

State law already bans sales to minors, with a fine of $100 to $500 for the first violation and $500 to $1,000 for the second violation. The bill would require the second-violation fine to be $1,000 and set a $5,000 fine for a third violation. A retailer with a fourth violation in two years would be banned from selling vapes. That would also apply to retailers who don't pay fines within 60 days.

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On 4th anniversary of Ky.'s first Covid-19 case, Beshear says it's a time 'to say that we're going to try to do better and better . . . '

Gov. Andy Beshear spoke at the observance of the fourth anniversary of Kentucky's first case of Covid-19. Next to him are Health Commissioner Steven Stack, in the front row, and Kandie Adkinson, in the back row. At the end of the front row are Rowena Holloway, widow of Virginia Moore, who was Beshear's main sign-language interpreter during the pandemic, and LeRoy Mitchell, who talked about his near-death from the disease and his sister's death from it. (Lantern photo by McKenna Horsley)

By Sarah Ladd
Kentucky Lantern

Four years after the day that Kentucky confirmed its first official case of Covid-19, Kandie Adkinson rang a singular bell in the state Capitol rotunda, its chime echoing through the marbled halls.

She did this to honor those lost to Covid-19, just as she did during much of the pandemic.

Adkinson was joined Wednesday by Gov. Andy Beshear and others who gathered in the rotunda to mark the day with grief for those lost to the virus and hope for the future.

In the last four years, nearly 20,000 Kentuckians have died with Covid-19. Many more contracted the illness and survived, like LeRoy Mitchell.

“Most of us know somebody that died because of Covid,” said Mitchell, who drives a bus for the Clark County school system.

His sister died with the virus on Sep. 5, 2020.

“If losing my sister was not devastating enough for me and my family,” he said, “four months later, Covid came for me in the worst kind of way.”

His wife discovered him on Jan. 8, 2021, he said. He was unresponsive and sent to the Clark County Regional Medical Center via ambulance then by helicopter to the University of Kentucky hospital’s intensive care unit in Lexington.

When he got there, he said, he “had no time to spare.” His doctors later told him Covid-19 had caused his diabetic coma and the blood clot in his lung, and was “trying to shut down my kidneys.”

He went on oxygen and spent three weeks in the hospital, followed by rehabilitation for two weeks. He grew weak in the hospital, losing 50 pounds during his ordeal.

“I … basically went back to being like an infant, baby stage. I could not do anything for myself,” he said. His road to recovery — complete with a wheelchair, walker, oxygen tank and supportive wife — took eight months, he said.

Ultimately, Mitchell told those gathered Wednesday, “Covid lost. And I won with life.”

Beshear signed a proclamation Tuesday making March 6 a “Day of Compassion.”

In the future, he said, “we want to, as much as we can every year, not just talk about the loss — and loss is important — but also talk about what good can come out of it?”

“While we don’t face a pandemic, we still face challenges right now. And if we could just approach them with a little bit of the same, at least, attempt to understand each other and love each other, then this world could be a much better place.”

March 6 should be a time to reflect, he said, “where we always say that we’re going to try to do better and better and better as the years go by.”

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March is Colorectal Cancer Awareness Month; Kentucky has the nation's fourth highest rate of death from colon cancer

Photo illustration by OnTheRunPhoto, iStock/Getty Images Plus

By Natalie Pitman
University of Kentucky

In March, we wear blue to recognize Colorectal Cancer Awareness Month, first observed in March 2000. Since then, it has become an opportunity to spread awareness about the importance of screening and honor those diagnosed with colorectal cancer.

Excluding skin cancers, colorectal cancer is the third most common cancer diagnosed in both men and women. It’s estimated that 106,590 new cases of colon cancer and 46,220 new cases of rectal cancer will be diagnosed in 2024. Kentucky has the fourth highest rate of death from colon cancer in the nation.

“The good news is colorectal cancer is easier to prevent than most other cancers and is highly treatable. It is often curable when caught early, and we could dramatically reduce complications from this disease by getting more people screened,” says Darwin Conwell, M.D., UK HealthCare medical pancreatologist and Jack M. Gill Endowed Chair in Internal Medicine at the UK College of Medicine.

Let's talk about the importance of colorectal cancer screenings and why they should be a priority for everyone.

What is colon cancer? The colon and rectum are parts of the digestive system. Colorectal cancer begins when cells that are not normal grow inside the colon or rectum. Early symptoms may be subtle, making regular screenings crucial for early detection.

Who should get screened? Most people should begin getting screened at age 45. You may need to begin screening earlier. Talk with your provider if you or a close relative has had colon polyps or colon cancer, or if you have an inflammatory bowel disease.

What are the different screenings? Screenings play a pivotal role in catching abnormalities before they turn cancerous. Detecting and removing polyps during screenings significantly reduces the risk of colorectal cancer.

There are different tests to detect colorectal cancer. For most people, the best test is the one they can complete. Talk with your primary-care provider about which test is right for you. More information is provided below or click on this link for a flyer.

UK HealthCare offers three types of colorectal cancer screening tests:

• Colonoscopy: The provider performing the screening can see and remove growths (polyps) in the colon and rectum during this test to prevent or detect colorectal cancer. You will need to take off work the day of the procedure. Some patients who take off the day before the procedure as well to complete bowel preparation. If a polyp is detected, it can be removed during the procedure. Screening is conducted every 10 years if results are normal.
• Cologuard: Your healthcare provider will order the Cologuard test to screen for colorectal cancer. Cologuard can be completed at home and is designed to detect abnormal cells in your stool. After you collect the sample, follow the Cologuard instructions to mail the sample to a lab. Results are sent to you and your provider. Screening is conducted every three years if results are normal.
• FIT Tests: The provider will test your stool sample for blood, by ordering a FIT test. You can complete the FIT test at home. Screening should be completed every year if results are normal.

A positive Cologuard or FIT test result is not the same as a cancer diagnosis, so please talk to your health care or telehealth provider for next steps.

“Colonoscopies are considered the gold standard for colorectal cancer screening, but stool-based tests like Cologuard or FIT tests can be a more accessible option if work, transportation, or family obligations are preventing you from getting a colonoscopy,” said Dr. Avinash Bhakta, a UK Markey Cancer Center colorectal surgeon. “Regardless of the test you choose, the most important thing you can do is get screened regularly.”

If you have a primary-care provider, or if you are in for a checkup or treatment, ask them if you’re due for your routine colorectal cancer screening. Based on your health history, they will be able to tell you which screening option is best for you.

Screening can help detect early signs and help monitor situations that can increase your risk of developing colorectal cancer. Getting screened for colorectal cancer is one of the most important ways you can take charge of your health.

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Don't forget to turn your clocks ahead March 10; sleep experts say sticking with standard time would be best for health, safety

CDC illustration

By Melissa Patrick
Kentucky Health News

It's almost time to "spring forward" one hour into daylight saving time, which sleep experts don't support because they say it doesn't align with humans' internal circadian rhythms. Daylight saving time begins Sunday, March 10 at 2 a.m. local time. 

The American Academy of Sleep Medicine says "The United States should eliminate seasonal time changes in favor of permanent ST [standard time], which aligns best with human circadian biology. Evidence supports the distinct benefits of ST for health and safety, while also underscoring the potential harms that result from seasonal time changes to and from DST." The AASM published its position statement in the Journal of Clinical Sleep Medicine. 

The authors explain that human activities are affected by three clocks: the internal biological rhythm, also known as the circadian clock; the solar clock; and the social clock. When these three clocks align, the authors write that this allows for optimal health and performance. 

But when the solar clock is misaligned with the other two, they write, that causes a desynchronization between the internal circadian rhythm and the social clock -- and that happens with the change to daylight saving time. 

"The yearly change between ST and DST introduces this misalignment, which has been associated with risks to physical and mental health and safety, as well as risks to public health," says the statement. 

The AASM statement has links to several studies that show the adverse physical and mental health outcomes that come from moving clocks forward in the spring, including a surge of heart attacks, strokes and car crashes, to name a few.

A new study of the heart-health effects by the Mayo Clinic "suggests that the impact is likely minimal," says a release from the clinic.

Federal law allows individual states to exempt themselves from observing daylight time, and Kentucky has a bill to do that. However, House Bill 674, sponsored by Rep. Steven Doan, R-Erlanger, has not even been assigned to a committee.

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Bowling Green hospital uses new technology to find lung cancer

Jennifer Finch, director of clinical intergration at Med Center
Health in Bowling Green, directs discussion of cases in the
hospital's new lung-cancer screening program. (Photo provided)

Kentucky Health News

The Medical Center at Bowling Green has established "a fast-track clinic that will help in the fight against lung cancer and give patients a better chance of surviving it," Ann Marie Dotson reports for the Bowling Green Daily News.

"The goal of the program is to detect lung nodules at the earliest stages to either prevent serious issues before they occur or to treat concerns quickly by offering a variety of options tailored to a specific diagnosis," Dotson writes, noting the it uses "a new technology that allows pulmonologists to biopsy smaller nodules."

Jennifer Finch, director of clinical integration at Med Center Health, said the program can detect cancer at stage 1, where there is a survival rate of 70 to 80%. “Historically, on small lesions, we had to wait and watch to see if they grew, but this computer-assisted robotic guided program guides the doctors to the small nodule, allowing them to get it,” she told Dotson.

The hospital said it started the program because Kentucky has the highest rate of new lung-cancer cases across the country, Dotson reports. It's a collaboration between its cardiothoracic surgeons, oncologists and Western Kentucky Heart and Lung board-certified pulmonologists.

"The team meets each Friday to view and discuss patients who may need further examination and review reports of patients who have incidental lung nodules and those detected through low-dose CT scans, working directly with the patient’s primary care providers," Dotson reports. "Eligible patients are then scheduled for consultations with the program’s team of physicians."

Finch told Dotson, “As a team, we review the patient’s history, whether the patient is a smoker, family history and cancer risk to see if the nodule could be benign or cancerous.”

Then the team devises a treatment plan "based on the patient’s needs, including further testing, surgery, diagnostic imaging, chemotherapy, radiation therapy or a biopsy." Finch said since the program opened Dec. 8, “we have had fantastic outcomes already.”

She added, “This program is really personal for me, and I have such a passion for it because my father died of lung cancer.” Kentucky leads the nation in lung cancer and deaths from it.

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CDC shortens Covid-19 isolation advice to match other viruses

Centers for Disease Control and Prevention photo

By Melissa Patrick
Kentucky Health News

The Centers for Disease Control and Prevention has updated guidance for how long people need to isolate when they get Covid-19, to match the guidance for dealing with other viruses. 

"While every respiratory virus does not act the same, adopting a unified approach to limiting disease spread makes recommendations easier to follow and thus more likely to be adopted and does not rely on individuals to test for illness, a practice that data indicates is uneven," the CDC said in a news release.

As of March 1, people who test positive for Covid-19 no longer need to stay isolated for five days, but instead can return to their regular activities if their symptoms are mild and improving and they have been fever-free for 24 hours without the use of a fever-reducing medication. 

"This advice is similar to what has been recommended for flu for decades and will help reduce the spread of Covid-19 and other respiratory viruses during the most contagious period after infection," says a separate advisory. 

Once people get back to their normal activities, the CDC acknowledges that some people may still be contagious. Because of this, it calls on people to take additional precautions for the next five days, such as gathering outdoors when possible, practicing good hygiene, keeping a distance from others and wearing a well-fitting mask. 

The CDC says it is making updates to the recommendations now because the U.S. is seeing far fewer hospitalizations and deaths associated with Covid-19 and because there are more tools than ever to combat flu, Covid and respiratory syncitial virus (RSV). 

“Today’s announcement reflects the progress we have made in protecting against severe illness from Covid-19,” Dr. Mandy Cohen, the CDC director, said in the release. “However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”

This updated guidance is intended for community settings only. There are no changes to guidelines for nursing homes and health-care facilities.

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