Sunday, September 29, 2019

Rural hospitals, already cut by Medicare, are about to get their Medicaid payments reduced, too; here's a partial Kentucky list

By Melissa Patrick
Kentucky Health News

Hospitals in Kentucky and across the nation are getting a reprieve, maybe a short one, from a new formula cutting the money the federal government gives them to care for poor people.

The cuts in Medicaid were supposed to go into effect Oct. 1, but Congress passed a continuing resolution to fund the federal government that, among other things, includes a provision to delay the cuts until Nov. 21. President Trump signed the resolution Friday.

"We are hoping that it will be delayed permanently," Carl Herde, vice president of financial policy at the Kentucky Hospital Association, told Kentucky Health News.

The cuts are for "disproportionate share hospitals," which care for a significant number of uninsured and Medicaid patients. DSH payments under Medicare are already being cut.

The Centers for Medicare and Medicaid Servicesfinal Medicaid DSH rule, issued Sept. 23, calls for payment reductions in fiscal years 2020-25, with a $4 billion cut in fiscal 2020 and $8 billion in each of the next four fiscal years. Federal fiscal years begin Oct. 1.

Those figures mean Kentucky hospitals' DSH payments in 2021 would be $60 million, 75 percent less than the 2018 total of $227 million, according to the Kentucky Hospital Association.

Rural hospitals in Kentucky would likely be hit hardest, since so many of their patients are on Medicare and Medicaid or have no health insurance. Almost one of every three Kentuckians is on Medicaid.

"The final method considers the rate of uninsured in each state, the number of Medicaid inpatients, the level of uncompensated care in the state and other budget-neutrality factors," Michael Brady reports for Modern Healthcare. "It also clarifies the definition of total hospital cost and specifies state data submission requirements. Lastly, it adjusts the weighting of certain factors required in the methodology by the Affordable Care Act."

Hospitals and providers agreed to take cuts after the Patient Protection and Affordable Care Act passed in 2010, because they assumed that the law would increase the number of people with insurance and decrease the number who couldn't pay their hospital bills.

"CMS issued a final rule in 2013 to implement cuts to DSH funding, but subsequent legislative efforts have delayed the federally required cuts," according to Becker's Hospital CFO Report.

CMS says its final DSH payment methodology “would mitigate the negative impact on states that continue to have high percentages of uninsured and are targeting DSH payments to hospitals that have a high volume of Medicaid patients and to hospitals with high levels of uncompensated care, consistent with statutorily required factors,” meaning the requirements of federal law.

Hospitals in Kentucky have already been hit by a separate round of DSH cuts from the Medicare program that will result in an estimated $77 million reduction by next year.

These cuts come because Medicare is no longer trying to mitigate what the industry calls the "Medicaid shortfall," or the difference between what Medicaid pays and the actual cost of care. That's a problem because Medicaid only pays 82% of the total cost of care, KHA says. The new formula now only includes charity care and bad debt.

But doing that shifts money from Kentucky and other states that expanded Medicaid to the working poor to states that didn't expand.

"States that did not expand have more charity and bad debt than those that did expand, but those that did expand have a lot more shortfall for Medicaid, obviously than the states that didn't expand," Herde said.

The Medicare DSH cuts are being phased in over two years. In the first round, Kentucky hospitals with the biggest cuts were: Norton Hospitals of Louisville, $8 million; Jewish Hospital & St. Mary's Healthcare of Louisville, $4 million; UK HealthCare, $2.7 million; and Baptist Health Lexington, nearly $2 million.

Cuts to rural hospitals were much smaller, but many have such small profit margins that they are at risk of closing, so any payment reduction is a concern.

For example, Pineville Community Healthcare in Bell County, which recently sold in a bankruptcy auction, saw a $171,500 cut.

The second round of Medicare DSH cuts are in motion.

A report by Navigant Consulting in February concluded that 16 of Kentucky's rural hospitals, one-fourth of the total, are at high risk of closing unless their finances improve. The report does not name the hospitals. Since 2009, five rural hospitals in Kentucky have closed, according to the Sheps Center for Health Services Research at the University of North Carolina, which tracks such closures.

The table of Medicare cuts is from the Kentucky Hospital Association and shows the first round of cuts for hospitals other than critical access hospitals, which operate under different rules.

Burkesville hospital open, similar one 24 miles away in Tenn. is closed; big differences: Medicaid expansion and diversification

OpenStreetMap contributors, via The Daily Yonder, adapted by Ky. Health News
Along the Cumberland River in Southern Kentucky and Middle Tennessee are two towns 24 miles apart by road. One has a hospital, and one does not, partly because Kentucky expanded Medicaid and Tennessee has not. But Cumberland County Hospital in Burkesville, Ky., hasn't just been lucky.

Cumberland River Hospital in Celina, Tenn., closed March 1, ending 146 jobs and undermining economic-development prospects in Clay County, which has a population of about 8,000. A physician assistant who has clinics in other rural Tennessee communities recently bought the hospital from Cookeville Regional Medical Center and says "he plans to reopen the hospital in phases, beginning with a clinic" Taylor Sisk reports for The Daily Yonder. "But the new owner will face the same challenges as did the former owners – as do most rural hospitals."

Neikirk and Capps (Daily Yonder photo)
Most recent rural-hospital closures have been in states that haven't expanded Medicaid under the 2010 Patient Protection and Affordable Care Act. Tennessee is one of those states. The expansion in Kentucky meant "survivability" for the Burkesville hospital, which is the main employer, with 340 jobs, in a county of 7,000, Chief Financial Officer Rick Capps told Sisk.

"He acknowledges, though, that expansion alone isn’t enough," Sisk reports. "A nonprofit owned by shareholders in the county, Cumberland County Hospital has diversified quite a bit over the past decade." It bought a local pharmacy and the county nursing home, runs the local 911 center and includes the practices of two physicians, Robert Flowers and Sam Rice, who have worked in the county for more than 30 years, Sisk reports: "That partnership, says CEO Rick Neikirk, has been key to the hospital’s success." So has its critical-access status, which gives it slightly higher government reimbursements in return for limits on its beds, services and patient stays.

Medicaid expansion also helps, in another way, Sisk notes: "With far fewer uninsured patients now entering their doors – a lighter burden of uncompensated care – the hospital has more flexibility to deviate from the standard model." In Celina, Medicaid expansion “would have helped, no question,” but probably wouldn't have kept the hospital open, Cookeville Regional CEO Paul Korth told Sisk.
Daily Yonder map, adapted by Kentucky Health News

Algal bloom warning issued for Ohio River above Louisville

The state Division of Water and Department for Public Health are warning people not to swim, wade or ski in the Ohio River from the McAlpine Dam at Louisville upstream to the Greenup Dam because several sections of the river have toxic algal blooms.

"Water ingested during recreational activities in this area may increase the risk of gastrointestinal symptoms such as stomach pain, nausea, vomiting and diarrhea," the warning says. "Skin, eye, and throat irritation and/or breathing difficulties, skin rashes, as well as numbness or tingling of limbs may also occur after contact."

The state said toxins in the Cincinnati area "were well above the advisory threshold. Toxin-producing blooms that exceeded the advisory threshold were also identified on the Ohio River near Dover, and near Towhead Island in Louisville -- and additionally at Briggs Lake in Logan County," which was also included in the warning.

"Bloom conditions can change rapidly," the state advises, giving tips to avoid exposure to harmful algal blooms (HABs):
• Avoid direct contact, including swimming, wading, paddling, diving, and water skiing, with affected water that has a visible bloom, unusual color, or algal scum.
• People who are prone to respiratory allergies or asthma should avoid areas with HABs. Children may be particularly at risk.
• If contact has been made with water containing blue-green algae, wash off with fresh water. In some cases, skin irritation will appear after prolonged exposure. If symptoms persist, consult your health care provider.
• If fishing in affected waters, fish fillets (not internal organs) may be consumed after the fillets have been rinsed in clean, potable water.
• Prevent pets and livestock from coming into contact with water where HABs are apparent.

If you are concerned that you have symptoms that are a result of exposure to HABs, please see your doctor and call your local health department. For additional information about harmful algal blooms in Kentucky, visit the Division of Water’s HAB webage.

"Blue-green algae occur naturally in the environment and are a vital part of the ecosystem," the state says. "Harmful algal blooms arise when there are excess nutrients (phosphorus and nitrogen), sunny conditions, warm temperatures, and low-flow or low-water conditions. The more typical green algae, which do not produce toxins, come in many forms.

"Harmful algal blooms, on the other hand, appear as slicks of opaque, bright-green paint, but closer inspection often reveals the grainy, sawdust-like appearance of individual colonies. The color of the algae may also appear red or brown."

Saturday, September 28, 2019

Bevin wants 'inaccurate and defamatory' Democratic ad taken down; Frankfort paper finds it lacks context, but isn't baseless

Gov. Matt Bevin has asked TV stations to take down what his campaign calls a "factually inaccurate and defamatory" commercial that says Bevin has tried to take health care away from children and people with pre-existing conditions.

The Bluegrass Values ad, funded by the Democratic Governors Association, features Hoppy Henton, a Democratic activist fromVersailes, who says Bevin has tried "to take away health-care coverage, including vision and dental, from children" and has sued "in court to take away protection now that people have for preexisting conditions."

Davis Paine, Bevin’s campaign manager, said in a press release, “A look at the facts shows that every claim made in this ad is false,”

However, The State Journal of Frankfort reports, "Several claims made in the ad lack context, but they are not baseless."

The crux of the matter is Bevin's efforts to change Medicaid to require, among other things, "able-bodied" adults who are not primary caregivers to work, attend school, take job training, search for a job or volunteer 80 hours a month, if they don't qualify for an exemption or are in drug treatment. The plan has been blocked twice by a federal judge in Washington, D.C.; his rulings will be considered by three appellate judges on Oct. 11.

After the plan was vacated the first time, the Bevin administration moved to end free dental and vision benefits from about 460,000 Medicaid patients who gained their health insurance through the expansion of Medicaid to those with incomes up to 138 percent of the federal poverty line.

The cuts did not apply to pregnant women or children, but for several weeks in July 2018, "The new system — reportedly through a glitch — also led to multiple children and pregnant women being denied vision and dental care, as reported by several independent news outlets," Emily Laytham writes for The State Journal.

The Bevin administration eventually restored dental and vision benefits to the expansion population, as well as those unintentionally affected by the system glitch.

In its press release, the Bevin campaign does not mention the events of last summer, but cites a November letter from the U.S. Department of Health and Human Services saying: “Beneficiaries receiving state plan benefits will continue to receive covered vision services, dental services, and over-the-counter medications . . . all beneficiaries under 21 years of age receiving services through the demonstration will continue to receive all early and periodic screening, diagnostic, and treatment services.”

The ad also suggests that Bevin is suing to “take away protections … for pre-existing conditions.”

In June, Bevin and 14 other state officials appealed a federal judge's decision that limited access to association health plans, a type of insurance that makes it easier for small employers to band together, free of many of the requirements of the Patient Protection and Affordable Care Act. Such plans are intended to reduce small business owners' cost of providing coverage.

The U.S. Department of Labor says association plans "may not charge higher premiums or deny coverage to people because of pre-existing conditions," but Laytham reports, "Workarounds exist."

According to the American Medical Association, “There is a significant risk that AHPs could disproportionately impact individuals with pre-existing conditions” by charging “based on factors that are not explicitly defined in terms of health or medical conditions, but that closely track those forbidden factors."

The AMA notes that association plans are permitted to vary premiums by age, gender, industry and geography, factors that can be used to predict or anticipate pre-existing conditions.

Bevin’s campaign did not respond to The State Journal's request for comment.

Attorney General Andy Beshear, the Democrat running against Bevin in the Nov. 5 gubernatorial election, says he would immediately rescind Bevin's Medicaid plan if elected.

Schuster wins top health policy advocacy award for more than 40 years of work in mental health; calls for an end to stigma around it

By Melissa Patrick
Kentucky Health News

Sheila Schuster, who has spent more than four decades advocating for those with mental illness and other disabilities, and worked to increase access to health care across Kentucky, was named the first Gil Friedell Health Policy Champion to a standing ovation by an audience from all over Kentucky.

Left to right: Mark Carter, Sheila Schuster, Ben Chandler, LeChrista Finn
The Foundation for a Healthy Kentucky award was presented at the organization's annual policy forum in Lexington Sept. 23, exactly one year after the death of Friedell, who was a fierce advocate for health equity and finding community-based solutions to the many health issues that plague Kentucky.

"This award is a tremendous honor. I treasure it even more because it is named for Gil Friedell, a mentor, friend and role model," Schuster said with great emotion. "Gil's legacy of health advocacy inspires me every day to do all I can to improve the lives of my fellow Kentuckians."

Schuster, a psychologist and mental-health advocate, selected Mental Health America of Kentucky to get the $5,000 cash grant that came with the award. She said she chose MHA because it was the oldest mental-health advocacy organization in the state and because it had partnered with her organization, the Kentucky Mental Health Coalition, on numerous policy initiatives.

Ben Chandler, president and CEO of the foundation, said in a news release, "Sheila is passionate about improving mental health, she is passionate about ensuring access to health care, and she is passionate about going about her work in a way that garners both respect and results."

Schuster was chosen from this year's 10 Healthy Kentucky Policy Champion recipients, Kentucky individuals or organizations recognized by the foundation for their engagement in improving the health of people in their communities and/or the entire state through policy change.

Sheila Schuster accepts Friedell award
In addition to leading the Advocacy Action Network, an umbrella organization that includes groups addressing health care, mental health, social justice and disability issues, Schuster also chairs Kentucky Voices for Health, a coalition to improve Kentucky's health, and leads the Kentucky Mental Health Coalition, which comprises more than 80 organizations. She chairs the Behavioral Health Technical Advisory Committee of Kentucky's Medicaid program. She has also held numerous leadership positions, including president and executive director, with the Kentucky Psychological Association.

"I love the policy work that I've done over the past 40 plus years," she said. "And to get an award for doing it is like icing on the cake."

And not to let an opportunity pass, Schuster spoke about the challenges of stigma when it comes to mental health and encouraged the 360 people in the room to do their part to reduce it.

"And while I have the mic, I'd like to close by urging each of you to do whatever you can to reduce the stigma that envelops mental illness, making it so difficult for our people to seek the help they need and to feel OK about it," she said.

"Stigma causes us to fear and isolate individuals with mental illness, to unfairly blame them for mass shootings when they are 10 times more likely to the the victim of violence than to be its perpetrator. Think about your language, examine your attitudes and do something positive to support those who are struggling with mental health issues. Never underestimate what a kind gesture, an understanding word or a listening ear can do to tear down that stigma."

Ben Chandler awarded Kentucky Medical Association's advocacy award for his work on flu prevention and tobacco-free efforts

Dr. Bruce Scott (L), Ben Chandler (R)
Kentucky Medical Association photo.  
The Kentucky Medical Association awarded Ben Chandler, president and CEO of the Foundation for a Healthy Kentucky, with its advocacy award for his efforts around tobacco-free policies and partnership in the 2018 "Focus on Flu" campaign.

The award is presented to individuals who have effected positive change in the healthcare space through their advocacy efforts, a KMA news release said. Chandler received the award at the association's 2019 annual meeting on Sept. 21 in Louisville.

Through his work with the foundation, Chandler has partnered with numerous outside organizations, including the KMA and its Kentucky Foundation for Medical Care. Together, these groups launched a “Focus on Flu” campaign last year to mitigate the effects of another deadly flu season in Kentucky.

Chandler is chair of the Coalition for a Smoke Free Tomorrow, made up of various stakeholders from across the state. In 2018, the coalition successfully secured a 50-cent increase in the state’s tobacco tax, to $1.10 per pack, and in 2019 helped pass a statewide tobacco-free schools law.

This year, the foundation, KMA and KFMC have once again partnered to offer campus signage at no cost to schools who comply with the law, which takes effect next summer.

The release notes that flu prevention and smoking cessation are two of the focus areas of KMA’s “AIM for Better Care: Administrative Improvements in Medicine” initiative.

Friday, September 27, 2019

Founding dean of UK College of Public Health, Dr. Douglas Scutchfield, wins top award from American Public Health Assn.

F. Douglas Scutchfield, M.D.
Dr. F. Douglas Scutchfield, a retired public-health professor at the University of Kentucky, is the recipient of this year's top award from the American Public Health Association.

Scutchfield, a native of Wheelwright in Floyd County, will receive the Sedgwick Memorial Medal for Distinguished Service in Public Health "for his outstanding accomplishments in academic medicine and public health, an APHA news release said. He "is being honored for his work on public-health accreditation, public health services research and mentorship, among other accomplishments."

Scutchfield was the founding dean of the San Diego State University School of Public Health and the UK College of Public Health, where he is Peter P. Bosomworth Professor emeritus. He has been an international leader in public health; he has been a consultant to governments and organizations in Panama, China, Saudi Arabia, Israel and Germany, as well as the U.S.

Scutchfield chairs the accreditation committee of the Public Health Accreditation Board, which accredits local and state health departments, and Kentucky has been a leader in getting its departments accredited. He was secretary-treasurer of the Association of Schools of Public Health, a member of the secretary of Health and Human Services' Health Promotion and Disease Prevention Council, and a board member of the Public Health Foundation, which presented him with the Theodore R. Ervin Award. He received the Balderson Lifetime Achievement Award of the National Public Health Leadership Network. He is editor-in-chief of the newly founded, freely available Journal of Appalachian Health.

Scutchfield earned his bachelor’s degree from Eastern Kentucky University and his medical degree from UK. Following practice in Morehead, and in conjunction with that work, he began his career at UK as a field professor of community medicine. He was the first chair of the Department of Family and Community Medicine at the University of Alabama, then an associate dean of its College of Community Health Sciences. Later he became founding director of the Graduate School of Public Health at San Diego State and held faculty appointments at the campuses in Irvine and San Diego.

He was certified by the American Board of Preventive Medicine in 1974 and the American Board of Family Practice from 1971 to 1985. He was a charter diplomat of the latter organization and is a fellow of both. He is a fellow of the American College of Preventive Medicine, served as a regent and president, and won the college’s Distinguished Service Award and Special Recognition Award. He has served as a member of the board and as president of the Association of Teachers of Preventive Medicine, which gave him its highest recognition, the Duncan Clark Award.

Scutchfield was a member of the American Medical Association House of Delegates and served as chair of the AMA Section Council of Preventive Medicine on several occasions. He was elected to membership in the AMA’s Council on Medical Education, and served as its vice chair and member of its executive committee. He represented the AMA as a member of the Accreditation Council on Graduate Medical Education, the Liaison Committee on Specialty Boards, the American Board of Medical Specialties and the Committee on Allied Health Education and Accreditation. He received AMA’s Dr. William Beaumont Award as its outstanding young physician in 1985 and its Distinguished Service Award, the highest recognition of a physician, in 2003.

Scutchfield has served as editor of the American Journal of Preventive Medicine and is a member of the editorial board of the American Journal of Public Health. He also served as editor of California Medicine and the San Diego Physician, both of which won awards during his tenure as editor. He served as editor of Appalachia Medicine and a member of the editorial board of the Journal of Community Health. He is the author of numerous textbooks, text chapters and published articles in referred journals. His avocational interest in Thomas Merton resulted in a book he co-authored with Paul Evans Holbrook Jr., The Letters of Thomas Merton and Victor and Carolyn Hammer: Ad Majorem Dei Gloriam, published by the University Press of Kentucky in 2015.

After VA fired him for 'egregious' misconduct, doctor was hired to run the state infectious-disease branch, and held job for 6 months

Gov. Matt Bevin's administration hired a physician to lead the state infectious-disease office soon after he had been dismissed by the U.S. Department of Veterans Affairs for "egregious" medical misconduct, Mary Meehan reports for Ohio Valley Resource, a consortium of public radio stations.

State officials were not aware of Dr. John “Mel” Bennett's misconduct at the time he was hired, the state Cabinet for Health and Family Services said in response to the story.

Dr. John "Mel" Bennett at the health department. (State photo)
The state hired Bennett in the same month that the VA’s inspector general published a report that said Bennett, from October 2015 to December 2017, entered the same blood pressure reading for hundreds of high-risk patients in order to avoid causing an alert that would require more work, Meehan reports.

An alert requires the provider to document additional follow-up care, such as additional blood tests or making changes to their medications. The inaccurate blood pressure data, according to the IG's report, were “most likely an effort to reduce workload.”

Several patients had adverse health outcomes because of the inaccurate information, and one suffered a "cardiac event," according to VA consultant Thomas Wong, in a podcast produced by the IG's office, Meehan reports.

The "IG found that Bennett falsified blood pressure readings in 99.5 percent of 1,370 cases involving patients at highest risk for developing health problems due to hypertension," the clinical name for high blood pressure, and "Documents show he recorded inaccurate information into patient charts 50 times in 10 days between Dec. 11 and Dec. 21, 2017," Meehan reports.

When confronted at the time, Bennett acknowledged the seriousness of the situation, according to records Meehan got with a federal Freedom of Information Act request.

The Kentucky Board of Medical Licensure later issued an agreed order outlining Bennett’s conduct and sanctions against him. In it, Lexington VA Medical Center Director Emma Metcalf called Bennett’s offenses “egregious," Meehan reports.

“You have lost the confidence of your colleagues regarding your reliability, accuracy, and integrity,” Metcalf wrote. “You have violated your patients’ and colleagues’ trust as well as failed to meet the standards entrusted to us as physicians.Your actions have placed veterans in harm’s way and violate the established principles governing the practice of medicine.”

The VA barred Bennett from treating patients at the facility on Dec. 26, 2017, when the investigation began; fired him on July 6, 2018; and sent a letter to the state licensure board two weeks later explaining its decision, Meehan reports.

The state health cabinet hired Bennett in September 2018 to lead the state’s infectious disease branch at a salary of $127,000, Meehan reports. The department works to combat and prevent contagious diseases like HIV and hepatitis A. Meehan notes that Bennett was hired during a hepatitis A outbreak that has killed 16 and sickened 4,900 Kentuckians.

Cabinet spokesperson Christina Dettman told Meehan in an email that the VA published its report after Bennett was hired and that “the findings did not identify Dr. Bennett as the physician under investigation.”

Bennett's hiring was approved by Dr. Jeffrey Howard, the health commissioner at the time. He was on the licensure board, which received the VA’s letter in July. However, Meehan reports that "board rules require such information to remain confidential for some time until an investigation is complete," so Howard would not have been notified of the VA letter at the time Bennett was hired. Howard declined to comment.

“The Cabinet for Health and Family Services had no way of knowing Dr. Bennett’s conduct was in question when he was hired by the cabinet, nor at any point during his tenure with the cabinet through the time he was terminated,” Dettman wrote in a separate e-mail after the article was first published.

Bennett remained in charge of the infectious disease office for six months until his removal in April. He said at the time that the state gave him no reason for his firing. That is the usual procedure for dismissing employees who are not part of the Merit System, the state's version of civil service.

Bennett's resume at the time he applied for the job said he was still employed by the VA, though he had been fired in July.

Bennett told Meehan that he was unaware of entering the same blood pressure over and over but also that it was a treatment strategy. “I thought I had an ability to, to sub-categorize my patients into a group that I can work with at a later date,” he said. “It was wrong.”

"Bennett gave a similar explanation to both the VA and the licensure board," Meehan reports. "Both rejected his arguments." In June, the board put Bennett’s license on probation for five years, ordered him to complete training and pay a $5,000 fine.

The state has had trouble keeping a manager of the infectious-disease branch. Bennett replaced Dr. Robert Brawley, who was allowed to resign in lieu of being fired on June 4, 2018. Brawley had wanted the state to respond more aggressively to the Hepatitis A outbreak, the nation's worst.

It's flu season, and 154 Kentuckians have already been diagnosed with it; the best defense is an easy-to-get vaccine

By Melissa Patrick
Kentucky Health News

The beginning of fall means it's also the beginning of flu season, prompting health officials to remind Kentuckians it's time to get vaccinated as a way to not only protect themselves, but also their loved ones. Flu season runs through May 2020.

Kentucky has already seen 154 confirmed cases of the flu since Aug. 4, according to the state health department. Last year, which was the nation's longest flu season ever, 194 Kentuckians died from the flu, two of which were children.

"Getting the flu can be debilitating and sometimes life-threatening," Dr. Angela Dearinger, the state's health commissioner, said in a news release.“Vaccination is the best tool we have to prevent the flu. It is also extremely important to take simple preventive steps to avoid the flu and other illnesses that tend to circulate at this time of year – wash your hands frequently, cover your mouth when you cough or sneeze and stay home when you are sick.”

Flu is a highly contagious disease caused by the influenza virus that spreads from person to person. Symptoms include fever, headache, cough, sore throat, runny nose, sneezing, fatigue and body aches.

An antiviral drug can shorten the course of the illness or reduce its severity if given within two days of a person getting the flu, but there is no real treatment for the disease, and that's why health officials encourage everyone six months and older to get a flu shot.

The flu season has been particularly bad in the last few years, largely because the vaccine hasn't been a perfect match for the circulating virus, but the Kentucky Department for Public Health says the vaccine has been changed this year in hopes it will offer better protection against it.

Regardless, health officials urge everyone to get vaccinated not only because it reduces your risk of getting the flu, but because it also lessens the severity of the illness if you get it and makes you less likely to develop complications of the virus. It's also important to get vaccinated early because it takes the vaccine two to four weeks to become effective.
Centers for Disease Control and Prevention graphic; click on it to enlarge
Overall, about half, or 49.6 percent, of Kentuckians six months and older were vaccinated during last year's flu season, according to the Centers for Disease Control and Prevention. And while that rate has largely remained about the same since the 2010-11 flu season, last season's rate showed a slight increase from the 2017-18 season when that rate was 44.1%. 

The CDC recommends that everyone over six months of age get a flu vaccination every year, and especially people who may be at higher risk for complications or negative consequences. They include:
  • Children aged six months through 59 months (just before turning 5);
  • Persons 50 or older;
  • Women who are or will be pregnant during the flu season;
  • Extremely obese people (body-mass index of 40 or greater);
  • Infants six months and older with chronic health problems;
  • Residents of nursing homes and other long-term care facilities;
  • Household contacts and caregivers of children younger than 5 and adults 50 and older.
  • Household contacts and caregivers or people who live with a person at high-risk for complications from the flu; and
  • Health care workers, including physicians, nurses, medical-emergency response workers, employees of nursing homes and long-term care facilities who have contact with patients or residents, and students in these professions who will have contact with patients.
Pregnant women are encouraged to get vaccinated before or during their pregnancy because it also provides immunity to their baby up to 6 months of age. That's when infants are old enough to get vaccinated.

Medicaid and Medicare and most private insurance providers cover flu vaccination as a preventive service, according to a news release from the Northern Kentucky Health Department.

Thursday, September 26, 2019

Juul stops all ads, gets a new CEO, and says it won't lobby on proposed ban of most electronic-cigarette flavorings

Juul products (Photo by Bill O'Leary, The Washington Post)
The leading manufacturer of electronic cigarettes, Juul Labs, suspended advertising its products Wednesday, Sept. 25, and said "its chief executive officer is stepping down and will be succeeded by a top official from Altria Group," which owns 35 percent of Juul, reports Laurie McGinley of The Washington Post.

On the same day, Altria and Philip Morris International said they had ended talks about a merger that would re-unite the companies that dominate the world's cigarette industry.

All three developments "underscore the concerns prompted by continued increases in underage e-cigarette use and growing alarm over a mysterious lung ailment linked to vaping that has stricken at least 530 people, nine of whom have died," McGinley notes. "Officials said Tuesday that they still don’t know the cause.were signs of the "public uproar over a surge in youth vaping,"

Juul also said it wouldn't lobby "on a planned ban on flavored vaping products recently announced by President Trump," McGinley writes. The Food and Drug Administration is moving to enact the ban.

At a congressional hearing, acting FDA Commissioner Norman “Ned” Sharpless said “In retrospect, the agency should have acted sooner” against e-cigarettes. "Sharpless said earlier data had suggested that youth vaping was declining and noted the agency has issued thousands of warning letters and penalties involving underage sales in the past year and a half," McGinley reports.

"Juul, under pressure from the FDA, stopped selling many of its flavored products in retail settings late last year. But it still sells mint and menthol flavors in stores — and recent data showed that those products have become increasingly popular among young people. The policy outlined by the FDA and the White House earlier this month would include mint and menthol flavors, as well as sweet and fruity ones, and cut Juul sales by 80 percent, according to estimates."

Wednesday, September 25, 2019

Sellout crowd at first major Ky. forum on medical cannabis hears there's no scientific literature to back it, but research is sparse

By Melissa Patrick
Kentucky Health News

The health benefits of medical marijuana haven't been proven and more research is needed, according to a leading researcher on the topic, but that hasn't stopped 33 states from approving it. It's still to be determined what will influence Kentucky lawmakers as they again consider passing such a law.

Ben Chandler
In the last legislative session, Kentucky legislators were able to get a bill to legalize medical marijuana out of committee. And though it wasn't called up for a House vote so late in the session, and key Senate leaders are opposed to it, its sponsors have vowed to try again in January.

On Sept. 23 in Lexington, the Foundation for a Healthy Kentucky held the first major conference in Kentucky about the issue, at its annual policy forum. "Medical Marijuana Fact and Fiction: Practical Public Health Policy Considerations for Kentucky" drew a sellout crowd of 360 to the Marriott Griffin Gate Resort in Lexington.

"If this is coming our way, shouldn't public health, shouldn't the medical community, shouldn't the people who care about the welfare of the citizens of this state have an important voice and an important place at the table during these discussions?" asked Ben Chandler, president of the foundation. "I'm afraid that they might not have that place, if everybody puts their head in the sand."

Chandler told the crowd that the forum was being held to look at the evidence regarding the public-health impact of legalized medical marijuana, increasingly known as cannabis (its biological genus).

"The Foundation for a Healthy Kentucky has not taken a position on the subject as yet, but what we do believe is this: whatever Kentucky ultimately decides to do, it ought to make that decision based on evidence," he said.

What does the research say?

Nationally recognized researcher Shanna Babalonis walked through several peer-reviewed scientific studies and said medical research does not support using cannabis for chronic pain, nerve pain, as a replacement for opioids, opioid-use disorder, anxiety or depression.

Shanna Babalonis
"All of the research that we can use right now just doesn't support it," she said, noting that the study of pain is complex. "We're not saying 100 percent that cannabinoids do not work for pain, it's just we're really limited in being able to demonstrate that," she said. "But if you strictly look at the scientific literature, there's really little to no signal that cannabinoids actually help . . . folks that have pain."

However, she said we don't have enough research on the medical benefits of marijuana because it is a Schedule I drug, meaning federal law classifies it as having no medical benefit. That means researchers need a special license to work with it, which involves a process that Babalonis described as "onerous."

Asked about studies from other countries that dispute her findings, Babalonis said they are typically based on self-reported, anecdotal information. While such studies have value, she said, scientists and physicians are held to a higher standard, ones that require randomized, well-controlled, well-executed, placebo-controlled methods of research.

Studies have suggested the presence of medical marijuana in a state reduces the number of opioid doses prescribed in it, and that opioid-overdose deaths have declined by 25 percent in such states, but Babalonis said such population-based studies are limited and don't dig deep enough into what is or may be causing these declines.

For example, she said, they don't show the relationship between those who use marijuana and those who have an opioid prescription. Nor, she said, do they account for other factors that influence opioid use and overdose deaths, like prescription monitoring programs, laws that address opioid prescribing, or access to Naloxone, a drug that reverses opioid overdoses. Also, she said more recent population-based studies show the opposite effect, that medical marijuana laws increase overdose deaths.

"There is no evidence that suggests cannabis can help with any aspect of the opioid crisis," Babalonis said. "We know virtually nothing about the interactions between the two, or how they come together to influence addiction and drug misuse." She added later, "I think it's really safe to say that it's absolutely reckless to suggest that cannabinoids are going to be the answer for the opioid crisis."

She concluded, "I think we just need to carefully consider what conditions will be permitted and what products will be permitted." Babalonis is an assistant professor at the University of Kentucky medical school, in its Center on Drug and Alcohol Research. She has a doctorate in behavioral neuroscience and psychopharmacology.

What's happening in Colorado? 

The keynote speaker at the forum, Andrew Freedman, oversaw Colorado's legalization of marijuana for both medicine and recreation. He talked about the impact of legalizing marijuana on a variety of public-health aspects. He now works at Freedman & Koski, a cannabis consulting firm, which he  co-founded. Colorado is one of 11 states that allow recreational marijuana.

Andrew Freedman
In essence, Freedman told the group that young people's use of marijuana in Colorado hasn't really changed since legalization, while adult use has.

He said past 30-day use among 12- to 17-year-olds increased slightly after it was legalized in 2012, from 10.5% to 11.2%, then peaked at 12.6% after the first stores opened in 2014, but has since decreased to  9% in 2016-17. The national rate in 2016-17 was 6.5%. This data came from the Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health.

Among adults in Colorado, from 2016 to 2017, use in the past 30 days increased in most age groups, from 13.6% in 2016 to 15.5%. That was largely driven by a rise in use among 18- to 34-year-olds. The report also shows that Colorado adults are using marijuana more frequently, with adult daily or near-daily use increasing from 6.4% in 2016 to 7.6% in 2017.

Freedman noted that there is likely some "observation bias" in those figures because people are more willing to admit use of marijuana since it is now legal to do so for any purpose.

The latest Gallup Poll found that 79% of Americans who oppose making medical marijuana legal say that the risk of increased car accidents underlies their opposition.

Freedman said in Colorado, fatal crashes involving marijuana have steadily increased over the years, from 47 in 2013 to 133 in 2017. He noted that Kentucky's death rate from all automobile accidents is well above Colorado's rate and the national rate.

Other key findings in the state report that were not mentioned include a slow upward trend of unintentional consumption among children under the age of 9, as well as related emergency-room visits. Freedman said Colorado has since changed its packaging requirements to require the manufacturer to use childproof, resealable packaging and that this has helped.

What's next? 

Freedman, like Chandler, encouraged the attendees to put aside their feelings about whether legalizing medical marijuana was a good idea or a bad idea, but to instead think about how to manage it from a public-health perspective in case it were to go forward.

In particular he encouraged efforts to restrict advertisements for marijuana, with a focus on making sure vulnerable populations aren't targeted.

All that said, some in the the medical community are pushing back. Dr. Danesh Mazloomdoost, with Wellward Regenerative Medicine, took issue with calling marijuana a medicine, stating that medicine is used to treat a specific condition with a specific dosage, and offers contraindications for people who should not be taking it -- and marijuana does not have such guidelines.

"As the medical community . . . the universal stance is that we don't feel comfortable as a clinician body to endorse marijuana as a medication," he said.

Mazloomdoost said he personally thought it should be labeled for what it is, a vice.

Freedman agreed: "I personally advocate for the broad public-health framework to be cannabis as an intoxicant. I think that does the best at preventing driving while high, preventing substance abuse, really looking at it from the government perspective, as this is an intoxicant that your people are taking and then they're in society."

He added, "We need a path forward to allow for sympathetic patients to continue to have access to cannabis, while the FDA catches up with research, because I think what we're hearing in polling, what we're hearing in the legislature is people are just simply tired of waiting."

Jaimie Montalvo
Jaimie Montalvo is one of those patients. He has multiple sclerosis, is a cancer survivor and says he has found relief for his conditions with cannabis. Montalvo is also the executive director for Kentuckians for Medical Marijuana, a nonprofit working for patients to have access to marijuana without fear of prosecution.  Montalvo participated in a panel at the forum, explaining the medical cannabis bill that he said will be filed.

Montalvo said in a telephone interview that Kentucky needs to pass a law to allow medical marijuana in Kentucky primarily for public safety. He pointed out that many Kentuckians have experimented with cannabis for their health conditions and found relief, usually after exhausting traditional medications that have either not worked, not worked sufficiently or have resulted in unwanted side effects.

"We need to make sure that what these patients are consuming is clean, is properly tested and is being sold in a safe environment," he said.

Things to consider

Freedman said Colorado also struggles with drug cartels that have come into the state and taken advantage of  its home-grow rules and the overall lack of regulation. He said many are growing cannabis in Colorado and selling it out of state because they get $800 a pound in Colorado and $3,000 a pound in unlisted states.

Another challenge is potency. "THC concentrations are sky high," said Babalonis. THC stands for tetrahydrocannabinol, the psychoactive ingredient in marijuana.

In the 1970s marijuana had a THC content of 1% to 2%, while today's products are around 17%, with dab and wax products closer to 80% or higher, she said. She added that medical marijuana is between 15% and 20%.

Freedman agreed, saying, "Potency is one of those areas that nobody knows what to do with right now. . . . We don't have a public-health framework for what is too potent, and what is not too potent."

Babalonis said, "One key thing that I just wanted everyone to take away from this meeting today is that there is not real differences in the products and in the plant material that is available for medical use versus recreational use . . . It's almost exactly the same. There's nothing special or protective about medical marijuana versus recreational marijuana."

And while marijuana use does not produce overdose or death in adults, it can be highly toxic to children and animals, she said.

Beau Whitney, with New Frontier Data, which provides data about the cannabis industry, told reporters that 480,000 Kentuckians have used marijuana in the past year, with a total market value of $800 million.

The latest Kentucky Health Issues Poll on this topic was conducted in the fall of 2012. It found that 78 percent of adults supported the use of medical marijuana if their doctor recommended it; 26% supported it for recreational purposes; and 38% approved it under any circumstances.

The latest Gallup poll on the topic, taken in May 2019, found that 64% of Americans favor legalizing cannabis for recreational purposes, with 86% of that group saying medical use of the product was a very important reason for their support.

Monday, September 23, 2019

Save the date: Friday, Nov. 15, to attend Covering Substance Abuse and Recovery, a workshop for journalists, in Ashland

UPDATE, Oct. 1: Registration for the workshop has opened! Click here for information, registration, hotel information, etc.

Covering Substance Abuse and Recovery: A Workshop for Journalists will be held in Ashland on Nov. 15 by the Institute for Rural Journalism and Community Issues and Oak Ridge Associated Universities.

The workshop is designed to help rural journalists cover a difficult subject, but one that needs covering to help their communities deal not only with substance abuse, but to know how recovery is possible.

More details and online registration will be available very soon, but several award-winning speakers who have been leaders in covering these topics in Appalachia and adjoining areas will speak:
  • Beth Macy, award-winning author of Dopesick: Dealers, Doctors, and the Drug Company That Addicted America, just released in paperback.
  • Terry DeMio and Liz Dufour, Pulitzer Prize-winning journalists from the Cincinnati Enquirer; DeMio has been the newspaper’s opioid beat reporter for five years, and Dufour is the lead visuals person on the beat and the Pulitzer-winning series, "Seven Days of Heroin."
  • Eric Eyre of the Charleston Gazette-Mail, who won a Pulitzer Prize in 2017 for revealing opioid distribution patterns in West Virginia.
  • Sharon Burton, editor publisher of the Adair County Community Voice in Columbia, a national leader in substance-abuse coverage by small newspapers.
  • Kentucky Justice Secretary John Tilley, who is a former legislator, attorney and television journalist.
Attendees will learn about the issues from a variety of experts in the field including award-winning journalists, authors, researchers, officials and people in recovery. The goals are to make sure they:
  • Understand the depth and breadth of the problem and how it affects local communities
  • Know how to get reliable data and other local information for reporting
  • Develop local, state, regional and national sources for stories and story ideas
  • Hear reporters explain how they cover the problem and the people affected by it
  • Appreciate the role of local news media in reducing the stigma that inhibit local action
Research by Oak Ridge Associated Universities has shown that the stigma attached to drug use and addiction are major obstacles to news coverage of the problem, which makes it harder for communities to find solutions.

The workshop will begin with a welcome reception on Thursday evening, Nov. 14, and run all day Nov. 15. Online registration will be required, with an early-bird registration rate of $50 to cover meals, snacks, and materials. Please contact Al Cross with any questions:

Sunday, September 22, 2019

New state health chief cautions against all electronic cigarette use; some recent illnesses aren't related to black-market THC

By Melissa Patrick
Kentucky Health News

HAZARD, Ky. -- At her first public speaking engagement as state health commissioner, Dr. Angela Dearinger spoke about the high rates of electronic-cigarette and tobacco use in Kentucky, focusing on the recent outbreak of illness related to e-cigs, with a warning that not all of the cases have involved black-market tetrahydrocannabinol, the psychoactive ingredient in marijuana.

Health Commissioner Dr. Angela Dearinger
"You may have heard that this has only happened to people who use THC products bought on the black market, and that's not the case. I want to make sure to make that point," Dearinger said at the fifth annual Appalachian Research Day sponsored by the University of Kentucky's Center for Excellence in Rural Health in Hazard Sept. 18.

"We may say that many of them did that, perhaps the majority," Dearinger continued. "But not every single case of severe lung injury associated with vaping is due to black market THC products."

She backed that up with numbers, saying that so far 61% of the products associated with vaping-related illness have contained nicotine, 80% have contained THC, and 7% have contained cannabidiol (CBD), a non-psychoactive product of the cannabis plant.

Dearinger said 45% of those products had both nicotine and THC; 38% had only THC; and 17% were nicotine only.

The Centers for Disease Control and Prevention says no specific vaping product or substance has been linked to all of the cases.

As of Sept. 17, the CDC had received reports of 530 cases of lung illness associated with the use of e-cigarette products, and eight people had died from it, the latest a man in his mid-40s from Missouri, according to a Missouri Department of Health news release. The other deaths occurred in California, Illinois, Indiana, Kansas, Minnesota and Oregon.

Graphic is from Health Commissioner Dearinger's PowerPoint
As of Sept. 20, Kentucky had 12 cases of pulmonary disease associated with e-cigarettes under investigation, with two probable cases and one confirmed, according to the Cabinet for Health and Family Services.

Dearinger said she focused much of her talk on young people because, "This is an illness that is affecting young people, predominantly."

The CDC has sex and age data on 373 of the cases, showing that 67% of those who have gotten sick are between 18 and 34; 16% are under 18; and 17% are 35 and older. Most are male: 72%.

Patients' symptoms include cough, shortness of breath and fatigue, with symptoms growing worse over a period of days or weeks before admission to the hospital. Other symptoms may include fever, chest pain, weight loss, nausea, vomiting, abdominal pain and diarrhea.

If you are experiencing any of these symptoms, health officials ask that you refrain from further use of electronic cigarettes, but keep the device for possible further investigation. The U.S. Food and Drug Administration encourages the public to submit detailed reports of any unexpected health issues related to tobacco or e-cigarettes to the FDA through its online Safety Reporting Portal.

Teen e-cig use is rampant

Dearinger pointed out reasons for concern about teen use of e-cigarettes: their rate of use nearly doubled in all age categories from 2016 to 2018.

Data from Kentucky Incentives for Prevention survey; graphic from
Health Commissioner Angela Dearinger's PowerPoint presentation.
According to the Kentucky Incentives for Prevention survey, 26.7% of the state's high-school seniors reported they had vaped in the past 30 days in 2018, up from 12.2% in the 2016 survey.

Use by sophomores, or 10th graders, increased to 23.2% from 11.3%; researchers consider the 10th-grade figures to be the better indicator for use by high-school students. Use by eighth graders jumped to 14.2% from 7.3%, and sixth-grader use increased to 4.2% from 2.3% over 2016.

Dearinger spoke at length about teen e-cigarette use, including issues around their high nicotine content, flavorings that are appealing to teens, targeted marketing and dangerous aerosols.

In particular, she pointed out the Lokee Vape products, which she said teens like because they are more affordable than the highly popular Juul brand, while still being just as easy to conceal since they often look like a key fob that can be clipped to a key ring. Further, she said their design is easy to use with THC.

She also reminded the group that Kentucky has the second highest smoking rate for adults in the nation, 25%, adding that they are even higher in the state's Appalachian region, with rates between 31% and 39%. The national rate is 14 %, according to the CDC.

What can be done?

As for how to decrease smoking and e-cig rates in Kentucky, Dearinger ticked off tried and true tactics: comprehensive smoke-free policies, hard-hitting media campaigns, access to smoking cessation programs and increasing tobacco prices.

"Communities that utilize all of these things have lower rates of smoking than communities that do not," she said.

She didn't mention taxes, but they came up in a question-and-answer session, and she said, "It absolutely works. It has been shown to work in other states. It does work."

And it seems to work in Kentucky, too. The year after the state increased its cigarette tax by 50 cents, to $1.10 per pack, 36 million fewer packs were sold in the state, a drop of about 10%, more than the national drop of 6.1%.

Since the state passed a law to require all Kentucky schools to be tobacco-free by next July 1, unless the district opts out, 148 of the state's 172 school districts have passed such a policy. Before the new law was passed, only 74 districts had done so.

Dearinger offered kudos to Hazard and Perry County for their recent efforts toward creating a smoke-free community. Perry is the first county in Eastern Kentucky to go smoke-free, and one of only six that have a comprehensive law that includes all workplaces and enclosed public places.

She also spoke about how to decrease teen use of e-cigs.

"When tobacco is expensive, and is not available in every store, and it doesn't come in kid-friendly flavors, fewer teens will smoke," she said. "If we have comprehensive smoke-free policies, fewer teens will smoke. If we have countered the marketing and promotion restrictions, fewer teens will smoke. And if we can help teens who want to quit, to quit, they will quit."

Later, she added, "We need to work together to make this happen . . . so that we don't have a generation of kids who are addicted to nicotine."

Trump 'stunned' electronic cigarette industry by choosing to ban almost all flavorings, The Washington Post reports

President Trump and first lady Melania Trump listened as
acting FDA Commissioner Ned Sharpless talks about a plan
to ban most flavored e-cigarettes. (Associated Press photo)
President Trump stunned the electronic-cigarette industry by saying the Food and Drug Administration would ban flavorings in e-cigarettes except for tobacco flavor, Laurie McGinley, Neena Satija, Josh Dawsey and Yasmeen Abutaleb report for The Washington Post.

"Juul Labs did everything in the power players’ handbook to cement its status in Washington," they write. "The Silicon Valley start-up worked to make friends in the nation’s capital. It hired senior White House officials wired into President Trump and the first family. It sent politically connected officials to the West Wing to extol its products. It spent big on lawmakers in both parties."

So, the Post reports, "The scope of the announcement stunned most of the industry, even big companies like Juul that have carefully nurtured relationships with policymakers to gain influence. But lately, those companies have also been undercut by a stream of reports about teen e-cigarette use and a mysterious lung illness tied to" use, perhaps misuse, of the devices.

Juul hasn't decided whether to challenge the proposed ban "on mint and menthol e-cigarettes, its two biggest moneymakers," the Post reports. "The company might argue to keep its menthol flavor on the market because it is legal in cigarettes and it wants to give smokers an alternative to menthol cigarettes, a Juul official said."

Their allies and consumers "were heartened by a Trump tweet Friday evening that suggested vaping might, in fact, be a good alternative to cigarettes, and the ban was simply to 'make sure this alternative is SAFE for ALL!' and to keep e-cigarettes out of the hands of children," the Post reports. "A senior White House official said the tweet reflected the president being told some supporters were upset by the ban, and did not signify a policy shift."

Not a spur-of-the-moment thing

"Despite its strong deregulatory approach, the Trump administration started focusing intensely on e-cigarettes a little more than a year ago when then-FDA Commissioner Scott Gottlieb saw data showing a 78 percent jump in high schoolers using e-cigarettes — a product ostensibly designed to help adult smokers quit cigarettes," the Post notes.

About the time he announced he would leave the job, Gottlieb accused Juul and its 35 percent owner, top combustible-cigarette maker Altria Group, "of reneging on commitments to quell teen use, according to people familiar with the discussions," the Post reveals. "He also said the companies were trying to undermine the FDA by going over his head to the White House, where the companies found a more sympathetic ear, they said."

As he left, Gottlieb proposed "sweeping sales restrictions — but not a ban," the Post notes. "Health and Human Services Secretary Alex Azar promised to continue the anti-youth-vaping agenda, suggesting officials might consider tougher action if youth vaping continued to increase. Then came a summer of devastating headlines about a mysterious vaping-related illness that had sickened 380 people in 36 states and resulted in seven deaths. Many of the victims used illicit marijuana products, according to health authorities and clinicians. But officials have not been able to unequivocally rule out nicotine products, giving vaping foes new ammunition to press their case for a crackdown."

Then first lady Melania Trump voiced concerns about e-cigarettes, and and presidential daughter Ivanka Trump also got involved, senior White House officials told the Post, which reports, "Some White House aides and political advisers were also concerned the vaping issue could become a 2020 campaign problem."

Matt Myers, president of Campaign for Tobacco-Free Kids, told the Post, “Juul has created more public outrage in a shorter period of time than any other company I can think of. When you prey on middle-class white kids, Republican or Democrat, you will make a lot of people angry.”

The stakes got higher when "Azar got new data right after Labor Day showing that 27.5 percent of high schoolers in 2019 said they had used e-cigarettes in the past 30 days, up from 20.8 percent the year before — the second big jump in two years," the Post reports. "The data also pointed to the surging popularity of mint and menthol e-cigarettes."

Trump's advisers gave him several options, "ranging from doing nothing to removing almost all vaping flavors from the marketplace," the Post reports. "The president, who had previously expressed no opinions about vaping, had also been reading stories about people dying from a mysterious lung disease, say White House officials. Faced with a perfect storm of worsening youth vaping numbers and fatal illnesses potentially related to vaping, he chose the toughest course."

The FDA has said its guidance would be published in several weeks and go into effect 30 days afterward. "Manufacturers could seek FDA approval to bring their products back to the marketplace, but it’s far from clear they would be successful," the Post says. "Those manufacturers had already faced a May 2020 deadline for such applications, which among other things would need to show whether the product would make it less likely adults would smoke regular cigarettes and not entice young people to start smoking. But under that earlier plan, companies could have kept their products on the market for some period of time while the agency weighed approval."

Only the big companies will be able to weather the storm if it continues, Michael Siegel, a professor of community health sciences at Boston University, told the Post. “Those are the only companies that are going to have the resources to put in the applications that are going to be required by the FDA. I’m sure that they’re already getting these applications together.”

Juul saw smaller companies cut into its market share after it "voluntarily stopped selling all flavors but mint, menthol and tobacco in retail outlets — and then watched as competitors and counterfeiters filled the void with their own sweet and fruity products," the Post reports. "Juul says it has been eager for a government crackdown on those products to level the playing field" and protect young people.

Health-care interests, using TV ads that hide who's paying for the air time, fight legislation to limit surprise or 'balance' billing; some ads come from air-ambulance companies, the big players

This ad claims the bill would help insurance firms and hurt patients.
Unknown people and businesses are giving millions of dollars to kill legislation nearing passage in Congress that would protect consumers from surprise medical bills. That's who's paying for those ads you're seeing on television. They're called "dark money" groups because they don't reveal their contributors.

"Pity the poor consumer trying to understand the coming congressional debate," writes journalist Trudy Lieberman, who considers patients' point of view. She says surprise bills have heaped "staggering amounts of debt ... on unsuspecting patients after they believed insurance had paid for their care. Those bills are growing rapidly and ensnaring more and more Americans in what has become one of the medical industry’s most unsavory business practices."

Lieberman notes a study just published in the journal JAMA Internal Medicine: "The number of surprise bills for both ER and inpatient admissions are rising. In 2010, about 32% of all ER visits resulted in surprise bills. In 2016, nearly 43% did. Surprise bills for inpatient admissions jumped from about 26% to 42% over the same period. What’s more, the average amount billed to patients for ER visits nearly tripled and the cost for inpatient admissions more than doubled."

With the TV ads, "the special interests that benefit from socking patients with additional bills" are trying "to convince consumers that any congressional efforts this fall to correct the surprise billing problem may actually harm patients," Lieberman writes. Noting the "Harry and Louise" ads that helped kill the Clinton health-care plan in 1994, she says "This kind of advertising works."

Lieberman says the industry is fighting hard because it fears "any kind of cost containment . . . something sorely needed, and bitterly fought for decades by the medical businesses whose incomes are at stake." 

The advertisers include a dark-money group called Another group, Doctor Patient Unity, which is targeting eight Republican senators, including Kentucky's Rand Paul and Majority Leader Mitch McConnell. KARE-TV in Minneapolis notes in an analysis that one of the bills "doesn’t set actually set rates for out-of-network procedures, but instead sets benchmarks for how much out-of-network providers can collect if a surprise bill shows up," Lieberman notes. "But in a TV ad that lasts a few seconds, how would the viewer be able to make that distinction?

University of Southern California research via Brookings Institution
"The air ambulance industry, which has gained notoriety over the last few years for its surprise billing tactics, too, has added its own ads to the confusing pile of persuasion aimed at the public," Lieberman reports. "According to, the industry has spent hundreds of thousands of dollars on TV and radio ads" using the name Global Medical Response. "The scary message is that air medical services are at risk. More than 30 bases have closed this year, disappearing from rural communities that need these services the most, the ad says."

The ad urges viewers to contact Congress about the surprise-billing legislation. "It’s not hard to see that someone living in a remote rural area might just do that," Lieberman writes. "Never mind that in the last few years media stories have revealed how families have been financially devastated from air ambulance bills, and that state laws are ineffective in regulating this industry."

"And if all this isn’t confusing enough," Lieberman writes, "there’s yet another group, called the Coalition Against Surprise Medical Billing. It represents large employers, health insurance agents, and business associations like the National Business Group on Health." This coalition wants to eliminate "balance billing," the main type of surprise billing, when "a patient is involuntarily treated by an out-of-network doctor, and wants to require health insurers to reimburse out-of-network providers based on local market rates negotiated by local providers. That would avoid what it calls a cumbersome arbitration process, the approach preferred by the aforementioned doctors’ groups.

Steve Wojcik, vice president of public policy at the National Business Group on Health, told Lieberman, “I believe that the investor-driven physician staffing firms fear that if our preferences become law, their business model — go out of network and raise prices — is shot.” He added, “Everyone agrees on banning balance billing. The disagreement is over payment rates and processes for determining payment for out-of-network physicians.”

Lieberman concludes, "The scary TV ads flooding the airwaves from this group or that mask the real issue. It all comes down to money and who gets how much. . . . How this turns out is anyone’s guess right now, and it may be that Congress has been sufficiently spooked by the TV ads targeting its members that it will be too timid to pass any legislation addressing this growing problem. But there’s one thing we do know from the history of health care battles: The longer the legislative fixes twist in the wind and the attack ads run, the less likely any real protections for patients become."