Showing posts with label federal regulation. Show all posts
Showing posts with label federal regulation. Show all posts

Wednesday, December 6, 2023

Biden administration again delays menthol-cigarette ban as Black support for Biden drops; anti-smoking advocates push back

Photo from ash.org
Kentucky Health News

The Biden administration has again delayed issuing a decision to eliminate menthol cigarettes, with plans to finalize the final rule next March, according to an updated regulatory agenda posted online by the White House Office of Management and Budget

Administration officials told The Washington Post that the delay comes after "fierce lobbying from critics who warn that a prohibition could anger some Black smokers who favor the product and could hurt President Biden's reelection prospects." Biden's support among Black voters has dropped about 20 percentage points in the past year, NBC News reports.

Four other officials told the Post, on the condition of anonymity, that the process could be delayed even further. 

The delay follows intense pressure from tobacco lobbyists, HealthDay reports.

Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement that it was "disturbing that this delay comes just two weeks after the tobacco industry and its army of lobbyists met with top officials at the White House." Further, she says the delay "allows the tobacco industry to continue profiting at the expense of Black lives." 

Richardson added, "The scientific evidence shows that menthol cigarettes are more addictive, easier for kids to start smoking and harder for smokers to quit. For decades, the tobacco industry has marketed these products to Black communities, causing devastating and disproportionate harm to the health of Black Americans. . . . Research shows that prohibiting menthol cigarettes will save up to 654,000 lives within 40 years, including the lives of 255,000 Black Americans."

When added to cigarettes and cigars, menthol’s minty taste and cooling effect limit throat irritation, making the products more appealing — especially new and young smokers — and it interacts with nicotine to enhance its addictive effects and makes quitting smoking harder, according to the Centers for Disease Control and Prevention.

According to research published earlier this year in the journal Nicotine and Tobacco Research, 43% of adults who smoked cigarettes in the past month in 2020 used menthol, with use most common among Black adults, at 80%. 

Prior to the announcement of the delay, the rule was widely expected to be published in late 2023 or early January, although it was likely be further delayed by legal challenges.  

The delay set in motion a string of statements from anti-smoking advocates calling on the Biden administration to issue the final rule by the end of this year. 

"Ending menthol cigarettes is pivotal to eliminating the dramatic health inequities in who uses tobacco products in the United States and who is most affected by tobacco-caused disease and death, said Harold Wimmer, president and CEO of the American Lung Association.

"Tobacco use is the number one cause of preventable death in the U.S. and claims 45,000 lives every year among Black Americans alone. A recent study quantified the disproportionate harms from menthol cigarettes to Black Americans, finding that menthol cigarettes were responsible for 1.5 million new smokers, 157,000 smoking-related premature deaths and 1.5 million life-years lost among Black Americans from 1980 to 2018. Halting the sale of menthol cigarettes lays the groundwork for reversing decades of disparities in tobacco use, disease and death in Black and Brown communities." 

Dr. Karen E. Knudsen, CEO of the American Cancer Society Cancer Action Networknoted that the Food and Drug Administration has had authority to ban menthol cigarettes and flavored cigars for 14 years and that any delay in doing so "only benefits the tobacco industry at the expense of public health. Tobacco is a primary driver of all cancer disparities, and the number one cause of cancer deaths nationwide, and flavors like menthol have been proven to make it easier to start and harder to quit using deadly products. There is no scientific rationale for permitting any flavored tobacco product to remain on the market. FDA stated that a comprehensive end to the sale of menthol cigarettes is projected to result in 324,000 to 654,000 fewer smoking related deaths." 

The FDA is also pursuing a ban on flavored cigars and new limits on nicotine in cigarettes, although the process of finalizing those rules is to be delayed until at least March as well, the Post reports. 

Nancy Brown, CEO of the American Heart Association, also issued a statement of concern, urging the administration to issue "strong final rules without delay." She said, "Each day we wait for the final rules to be released is another day Big Tobacco will hook new users and target communities with menthol cigarettes and flavored cigars."

Tobacco companies continue to oppose the ban, "insisting science shows menthols pose no greater risk than other cigarettes," the Post reports. "R.J. Reynolds, which makes Newport, the nation’s top-selling menthol brand, said in a statement Tuesday that a ban would hurt small businesses, dent tax revenue and contribute to a dangerous illegal market."

Saturday, October 7, 2023

UK gets $19 million to study tobacco-product markets and possible additional federal regulation of them in Kentucky

AppalTRuST draws from UK's colleges of Medicine, Nursing, Public Health, Education and Arts and Sciences, the Markey Cancer Center and Bridging Research Efforts and Advocacy Toward Healthy Environmennts (BREATHE). (Photos by Jeremy Blackburn , UK Research Communications)
Kentucky Health News


The University of Kentucky is one of seven institutions that are getting about $20 million each in federal money over the next four years to examine the potential impact of federal tobacco regulations.

The Appalachian Tobacco Regulatory Science Team, which UK has dubbed AppalTRuST, is funded by $19 million from the National Institute on Drug Abuse of the National Institutes of Health and the Food and Drug Administration Center for Tobacco Products.

"The goal of AppalTRuST is to investigate the impact of federal regulatory policies in rural communities through collaboration, education and pioneering regulatory scientific research," said a UK news release that alluded to Kentucky's longstanding health problems from using what was once its top cash crop.

“This is a state with its own struggles and health disparities associated with tobacco use, particularly in Appalachian Kentucky,” Dr. Seth Himelhoch, chair of the UK Department of Psychiatry and the grant's principal investigator, said in the release. “While America has overall reduced its use of combustible tobacco, Appalachian Kentucky, in particular, has not moved along at the same pace.”

Kentucky's adult smoking rate, 19.6% in 2021, is second only to West Virginia's.

Co-directors Teresa Waters, Seth Himelhoch and Ellen J. Hahn
“It seems very important to me that when the federal government is going to evaluate regulations for tobacco use it should certainly be doing so in a part of the country where decreasing combustible tobacco use is likely to lead to long-term health benefits including reductions in cancer and cardiovascular disease,” Himelhoch said.

UK Vice President for Research Lisa Cassis said, “Tobacco has long been an issue that challenges the health and well-being of Kentucky. It is our mission as scientists and stewards of our land-grant institution to advance the commonwealth beyond any obstacles to its public health. This award offers the team behind AppalTRuST an opportunity to lay a foundation for high-level, innovative and interdisciplinary research to make an impact on our state.”

The co-directors of AppalTRuST are Ellen J. Hahn, an endowed nursing professor and director of the Bridging Research Efforts and Advocacy Toward Healthy Environments (BREATHE), and Teresa M. Waters, dean of public health at Augusta University in Georgia, the former chair of health management and policy in the UK College of Public Health. The project involves that college and the colleges of Nursing, Medicine, Education, and Arts and Sciences, as well as the UK Markey Cancer Center.

Hahn said, “Kentuckians are at a much higher risk for heart disease, lung conditions and cancer due to high smoking rates and weak smoke-free protections. AppalTRuST will learn with and from the community to better understand their use of tobacco, retail marketing of tobacco projects, and consumer behaviors in rural communities. The health and economic burdens from tobacco use in our state is enormous, and we hope to foster sustainable change in our communities through this work.”

The project will focus on two regions — Boyd, Carter and Greenup counties in northeastern Kentucky, partly in a metropolitan area, and a more rural group of counties in southeast Kentucky: Breathitt, Knott, Leslie, Letcher and Perry.

The AppalTRuST team will start its research by looking at how people get tobacco products and provide an overview of the marketplace, including the prevalence and impact of marketing and how FDA regulations may affect tobacco use. It will also use a virtual storefront to evaluate how possible regulations would affect purchases of tobacco products.

“We hope the findings AppalTRuST produces will provide important information to the FDA as they regulate tobacco products in a way that positively impacts the health of Kentucky’s rural communities,” said Hahn, who created UK's Kentucky Center on Smoke-Free Policy.

The other six institutions awarded grants for Tobacco Centers of Regulatory Science are the University of North Carolina at Chapel Hill, the University of Michigan, Pennsylvauia State University, Ohio State University, the University of South Carolina and Yale University.

Thursday, July 7, 2022

Only 2.5% of Kentucky's 6,561 National Guard soldiers have refused vaccination for Covid-19; federal deadline was June 30

By Melissa Patrick
Kentucky Health News

As of July 6, only 2.5% of Kentucky Army National Guard soldiers have refused a Covid-19 vaccine, thus missing the June 30 federal deadline to get vaccinated. Another 2.5% have asked for an exemption, so 95% are largely in compliance, according to the agency's public-affairs office. 

Of the 6,561 Kentucky Guard soldiers, 6,233, or 95%, have had at least one dose of Covid-19 vaccine, are awaiting vaccination during their initial training, or are fully vaccinated, well above the national average of 89%, Lt. Col. Carla A. Raisler, the state guard's director of public affairs, said in an e-mail.

As for the rest, she said 2.5%, or 164, have refused vaccination, and the same share are awaiting adjudication of requests for an exception to the policy on religious or medical grounds.

When it comes to consequences, Raisler said the Kentucky National Guard is following the guidance from the National Guard Bureau in the Department of Defense. 

"NGB has declared drill periods, annual training and exercises as 'mission-critical.' Therefore, unvaccinated personnel who are pending adjudication for a medical or religious exemption for the coronavirus vaccination are authorized to continue attending training," she said. "Service members who are not fully vaccinated and do not have an approved or pending exemption may not attend training."

Raisler said 6% of guard members are either in the training pipeline or have not been fully vaccinated. She said those in training will not be affected by the mandate and those who have received one dose of the Moderna or Pfizer vaccine near the deadline of July 1 will only miss the July drill period. 

"This does not negatively impact them, their military career or their unit," she said. 

Further, she said soldiers whose exceptions are denied will be given the opportunity to receive the vaccination before any action is taken.

"If they refuse the order to be vaccinated they will be subject to certain adverse administrative actions, including flags, bars to continued service, and memoranda of reprimands," she said. "Soldiers who continue to refuse will be subject to administrative separation. However, we are giving them every opportunity possible to get vaccinated before mandating separation."

Raisler stressed that the Kentucky Guard has been proactive in educating and encouraging its service members to get vaccinated as a means to ensure they maintain their readiness. 

She said, "Kentucky National Guardsmen train all over the country and the globe, so it is essential to the health of our service members and their families that they receive their coronavirus vaccination, especially when training in areas of the world that have higher infection rates."

Tuesday, March 29, 2022

Cameron and 20 other attorneys general, most of them in GOP, sue to overturn CDC mask mandate in public transportation hubs

Attorney General Daniel Cameron has joined 20 of his counterparts in a lawsuit to overturn the Centers for Disease Control and Prevention's rule requiring masks to be worn in public transportation hubs.

The suit "argues that the mandate exceeds the authority of the CDC, noting that the Biden administration continues to use a failed interpretation of a quarantine statute that has been ruled against in court several times," Cameron's office said in a press release.

Cameron said, “With most states now relaxing their Covid-19 requirements, the CDC should follow suit and eliminate the mask mandate for airports, train stations, and other transportation hubs. We believe the current mask mandate exceeds the authority of the agency, and the Biden administration should end it immediately.”

The attorneys general, most of them Republicans like Cameron, argue that the law used to justify the mandate does not authorize such broad measures. only authorizes rules directly related to preventing interstate spread of disease, and does not permit mask requirements for individuals who show no sign of infection, the release says. The suit also argues that the rule is arbitrary and capricious and does not consider preventive actions by states.

The other plaintiff states are Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Mississippi, Missouri, Montana, Nebraska, Ohio, Oklahoma, South Carolina, Utah, Virginia and West Virginia. To read the lawsuit, click here.

Sunday, January 5, 2020

FDA bans sale of most flavors in cartridge-based e-cigarettes; menthol flavor still allowed, against health advocates' advice

By Melissa Patrick
Kentucky Health News

The Trump administration has announced a ban on the sale of flavored e-cigarettes except for menthol and tobacco-flavored products for cartridge-based systems, like pods produced by Juul, the leading manufacturer. The ban does not include flavors in tank systems sold in vape shops.

Science News photo
The U.S. Food and Drug Administration said in a news release that it made these concessions to support adults who use e-cigarettes as a quit-aide for traditional cigarettes.

“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustibles tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary," Department of Health and Human Services Secretary Alex Azar said in a news release.

The FDA has not approved any e-cigarette product as a smoking cessation method and the smokefree.gov website says, "So far, the research shows there is limited evidence that e-cigarettes are effective for helping smokers quit."

President Trump suggested in September that his administration would ban all flavors from the market except for tobacco, but backed off after protests from users, retailers and manufacturers.

On Dec. 31, two days before the policy announcement, Trump told reporters that the the new policy would protect both families and the industry,

"We're going to protect our families, we're going to protect our children and we're going to protect the industry. It's become a very big industry. We're going to take care of the industry," said Trump, adding that some products could "very quickly" return to the market.

Trump was referring to an FDA review process that requires manufacturers of new tobacco products put on the market since Aug. 8, 2016, to submit pre-marketing authorization applications by May 12, 2020 for their review. This process could allow some of the products that fall under the enforcement action of this policy to be approved and re-enter the market, including flavors.

Vaping advocates have said a full ban on flavored e-cigs would put vape shops out of business, and hurt adults who are trying to use the devices to quit.

Health advocates are more concerned about the public health impacts of these products, especially related to the surge in teen use which has been driven by the flavors. They have urged the Trump administration to take all flavored products, including menthol, off the market.

The FDA release says it didn't ban menthol because a 2019 federal survey found that fruit and mint flavors were the two most popular e-cigarette flavors among teens, with menthol least favored.

The 2019 "Monitoring the Future" study found that menthol was among the least popular flavors among students, at less than 2.3% for eighth graders, less than 3% for 10th graders, and less than 6% for high-school seniors.

However, public-health officials worry that the absence of other flavors will result in a shift toward menthol products, citing the National Youth Tobacco Survey, which shows that youth use of mint and menthol e-cigarettes increased in 2019 after Juul restricted its other flavors.

More than 6 million U.S. middle and high school students are current users of tobacco products, and 5.3 million of them, or 85 percent, are using e-cigarettes, according to the latest annual National Youth Tobacco Survey.

The latest data for e-cigarette use by Kentucky teens, from 2018, shows e-cig use had nearly doubled from 2016, with more than one in four high-school seniors and one of seven eighth-graders reporting they used the devices, the Kentucky Incentives for Prevention study found.

In an analysis of the FDA's industry "guidance" document, Stanton Glantz, director of University of California, San Francisco's Center for Tobacco Control Research and Education, pointed out that it has nothing to keep e-cig companies from simply re-labeling mint-flavored e-cigs as menthol. "After all, menthol is derived from mint," he writes.

The American Medical Association called the policy a step in the right direction, but added that it didn't go far enough.

“If we are serious about tackling this epidemic and keeping these harmful products out of the hands of young people,” the association said in a statement, “a total ban on all flavored e-cigarettes — in all forms and at all locations — is prudent and urgently needed,” adding that it was “disappointed that menthol flavors — one of the most popular — will still be allowed.”

A statement from the Campaign for Tobacco-Free Kids said the policy "falls woefully short of the bold action the administration promised" to address the youth e-cigarette epidemic. Further, it called the policy a win for the e-cigarette industry, saying the Trump administration had sided with "Juul, Altria, [which owns 35% of Juul], the vape shops and other e-cigarette interest over our kids."

"By leaving menthol flavored e-cigarettes widely available and totally exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic," said the organization's president, Mathew L. Myers. "It is a capitulation to both Juul and vape shops and gives a green light to the e-cigarette industry to continue to target and addict kids with flavored products."

Glantz also expressed concern that a product called Suorin, an e-cig that is highly popular with kids that is sold empty and has refillable pods, would be exempted. Further, he noted that the industry guidance states that "self-contained, disposable products," like the Puff Bar e-cigarette, which is also popular with teens, would be exempt. The Campaign for Tobacco-Free Kids adds that the Smok product, which is an open-pod, refillable system used by teens, would also be exempt.

Glantz called for localities and cites to keep passing laws to end the sale of all flavored tobacco products, but this is not possible in Kentucky because state law preempts local laws on sale, use and distribution of tobacco products.

On Dec. 20, Trump also signed, as part of the year-end spending bill, a measure that prohibits the sale of tobacco products to anyone under the age of 21. The FDA issued a statement on the same day saying the new age limit went into place immediately.

Friday, June 21, 2019

Bevin joins appeal of court ruling that blocked new association health plans; AG Beshear says they threaten health coverage

By Melissa Patrick
Kentucky Health News

Would 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, provide enough protections to consumers?

Business Management Daily graphic
Gov. Matt Bevin's health secretary says they would. Attorney General Andy Beshear, who is running against Bevin, says they wouldn't.

Bevin and officials from 15 other states, filed a court brief June 7 urging the U.S. Court of Appeals for the District of Columbia to reverse a lower court's decision against expanded access to association health plans.

The brief prompted a verbal tussle between Beshear, one of the original plaintiffs in the lawsuit, and Health Secretary Adam Meier, who released his statement from the governor's office, where he was deputy chief of staff, instead of the Cabinet for Health and Family Services, which he leads.

Beshear issued a statement saying, “I disagree with the governor’s new action because it threatens health care coverage for Kentuckians, including people with pre-existing health conditions. While Matt Bevin continues his work to strip vital coverage away from our families, I am fighting to make sure all Kentuckians get the health care they need and can afford it.”

In response, Meier called on Beshear to retract his "false and outrageous claim" and linked to official guidance from the U.S. Department of Labor that says association health plans "may not charge higher premiums or deny coverage to people because of pre-existing conditions."

“The Department of Labor has been very clear that association health plans cannot deny coverage to individuals based on pre-existing conditions,” Meier said. “To state otherwise is false and shows a complete lack of understanding of the intent of the Department of Labor rule, which is to provide workers and small businesses with greater access to affordable health insurance options. AHPs are a great way for sole proprietors and small businesses to have the same kind of health coverage that big corporations offer their employees.”

Technically, Meier is correct. But critics of the AHP rule say that while they recognize that the guidance says AHPs can't deny coverage based on pre-existing conditions, the rest of the policy is set up to allow them to easily do so by simply denying coverage for conditions they don't want to cover, such as not covering insulin for diabetics or not covering mental-health care.

The American Medical Association sides with Beshear on this issue. In a 2018 friend-of-the-court brief, the AMA laid out a list of concerns.

 "There is a significant risk that AHPs could disproportionately impact individuals with pre-existing conditions," the AMA said. "To be sure, on its face, the regulation states that it protects coverage of pre-existing conditions. But in reality, AHPs can easily evade that crucial legal requirement by using proxies for health status."

For example, AMA wrote that AHPs "can charge premiums based on factors that are not explicitly defined in terms of health or medical conditions, but that closely track those forbidden factors."

Further, it notes that the AHP rule allows them to charge different premiums based on age, gender, industry or geography. "But each of those seemingly neutral characteristics can be used to disguise differential treatment based on health status or one's likelihood of suffering from particular pre-existing conditions."

The AMA argued, "Denying patients coverage based on seemingly neutral characteristics that the insurance industry knows, in reality, are associated with higher medical costs or pre-existing conditions would leave patients with lower quality care, greater out-of-pocket expenses, and overall poorer health outcomes. Those consequences subvert the object and design of the ACA."

In addition to its concerns that AHPs will undermine the consumer protections in the ACA, the AMA said they would destabilize ACA exchanges by pulling healthy individuals out of ACA plans.

Citing examples, the AMA also noted that AHPs  have a "long history of fraud and abuse" and adds  that the AHP rule itself recognizes this when it says, "The Department anticipates that the increased flexibility afforded AHPs under this rule will introduce increased opportunities for mismanagement or abuse, in turn increasing oversight demands on the Department and state regulators."

What's it all about? 

President Donald Trump signed an executive order in 2017 to expand access to association health plans, stating that expanding access to such plans would "allow more small businesses to avoid many of the [Patient Protection and Affordable Care Act's] costly requirements."

In June of last year, the Department of Labor did just that, by expanding the types of groups that could ban together to offer coverage under an AHP.

The department also loosened association requirements so that more of them could be classified as large-employer coverage, which would exempt them from having to cover the 10 essential health benefits required by the ACA, like covering mental health or prescriptions. Nor, under the new rule, would they be required to pay the tax that large -group market insurers have to pay when they choose to not cover them. As previously noted,  association insurers can set premium rates based on age, gender, industry or geography.

In March 2019, the policy was struck down in federal court following a lawsuit filed by 11 attorneys general, including Kentucky's Beshear.

In his ruling, Judge John D. Bates, of the U.S. District Court for the District of Columbia, who was appointed by President George W. Bush, concluded that the labor department "unreasonably expands the definition of "employers" to include groups without any real commonality of interest" and that it had  misinterpreted the Employee Retirement Income Security Act's definition of an employer when it allowed working owners without employees to be covered by the AHPs. Bates added that the policy "was intended and designed to end run the requirements for the ACA."

This month, Bevin, along with 15 other states, filed a court brief urging the federal appeals court to reverse the district court's ruling. Bevin's involvement put Kentucky on both sides of the issue.

"By broadening the definition of a qualifying employer, more small businesses can take advantage of that purchasing leverage," says the brief. "Thus "a substantial number of uninsured people will enroll in AHPs because the Department [of Labor] expects the coverage will be more affordable than what would otherwise be available to them.""

AHPs in Kentucky?

The 2019 Kentucky General Assembly overwhelmingly passed House Bill 396 to update the Kentucky insurance code to adopt the Department of Labor's final rule and expansion of AHPs. Bevin signed it into law March 26.

Kentucky already has some association health plans that are fully insured and industry specific for employer groups, but has not approved any under the new policy, said Susan West, spokeswoman for the Public Protection Cabinet, which includes the Kentucky Department of Insurance.

West said in an email that the state was "on the cusp" of approving a fully insured AHP under the new rules that would have gone into effect June 27, but it has since been put on hold because of the federal court ruling and subsequent appeal. 

"Given the recent federal ruling and discussion among regulators at the recent [National Association of Insurance Commissioners] meeting, in which Kentucky participated, the DOI is waiting on the federal [Department of Labor] to determine their course of action and appellate options before moving forward with approving specific plans and registering associations," West said.

Sunday, June 9, 2019

Six Kentucky nursing homes are on a formerly unpublished list of 400 poor performers around the nation

Of the six Kentucky facilities on the poor-performers list, only
Twin Rivers Nursing and Rehabilitation Center in Owensboro
is getting additional oversight. (Photo from Owensboro Times)
By Melissa Patrick
Kentucky Health News

The U.S. senators from Pennsylvania have released a report that includes the names of nearly 400 nursing homes with a "persistent record of poor care" that had not previously been publicly available.

Six are in Kentucky: Klondike Center and Springhurst Health and Rehab in Louisville; River Haven Nursing and Rehabilitation Center in Paducah; Woodcrest Nursing and Rehabilitation Center in Elsmere; Mountain Manor of Paintsville; and Twin Rivers Nursing and Rehabilitation Center in Owensboro.

Some issues listed in the report specific to the Kentucky nursing homes were failure to provide prescribed medication and treatments, failure to inform providers when the treatments were missed, and failure to provide appropriate burn-wound care, which resulted in a state inspector finding the individual "lying in bed with a large amount of green drainage on dressing and a pool of green drainage on the bed sheets."

Pennsylvania's senators, Democrat Bob Casey and Republican Pat Toomey, released the list after questioning why the federal government only shares a list of about 80 failing nursing homes that get special oversight until their issues are resolved, and not the list of nearly 400, which also qualify for the oversight program, but aren't included because of "limited resources."

The 80 nursing homes that get the additional oversight are "special focus facilities" and are identified on the federal Nursing Home Compare website with a small yellow triangle. Those on the list of 400 are candidates for this special program, but are not identified in any way on the website as nursing homes that provide persistently poor care.

The senators' report says, "Despite being indistinguishable from participants in terms of their qualifications for enhanced oversight, candidates are not publicly disclosed. As a result, individuals and families making decisions about nursing home care for themselves or for a loved one are unlikely to be aware of these candidates."

Owensboro's Twin Rivers Nursing and Rehabilitation Center is the Kentucky's only "special focus facility" on the list. The report says that the only parties who have known if a nursing home is a candidate to be a special-focus facility are the Centers for Medicaid and Medicare Services, the government of the state in which the nursing home is based, and the facility itself.

The report says CMS has not consistently updated these nursing homes' data on Nursing Home Compare; it says nine are listed as having perfect scores for staffing and quality of care.

Further, it says that the nursing homes that are considered special-focus candidates do not face additional oversight, are not surveyed more frequently, nor are they "subject to more rigorous enforcement actions, additional disclosure or reporting requirements."

“There is no information on Nursing Home Compare explaining the reason for a facility’s participation in the program, the length of time it has been in the program or whether it has improved,” the report said.

About 1.3 million Americans live in 15,600 nursing homes, according to CMS.

Wednesday, May 22, 2019

Ky. has new tool to track the ongoing changes to its Medicaid program, including county-by-county enrollment numbers

Kentucky has a new website that shows an up-to-date timeline of all the changes in the state's Medicaid program since 2014; provides links to Medicaid resources such as contracts, court documents, state notices and research; and provides a place for people to share stories about how changes to the program have affected them or their loved ones. It also provides Kentucky-specific Medicaid data, including county-by-county enrollment.
Screenshot showing example of looking up county-by-county data on the Kentucky Medicaid Tracker
The Kentucky Medicaid Tracker is a combined project of the Kentucky Center for Economic Policy, the Kentucky Equal Justice Center and Kentucky Voices for Health.

Each of these nonprofit organizations are part of InsureKY, which describes itself as a statewide coalition of nonprofits formed to promote more affordable insurance, better care and stronger consumer protections for all Kentuckians. They support the 2014 expansion of Medicaid.

Kentucky Medicaid has seen many changes since then-Gov. Steve Beshear announced in 2013 that the state would  expand Medicaid to Kentuckians with household income up to 138% of the federal poverty line, under the 2010 Patient Protection and Affordable Care Act. Prior to the expansion, the program was limited mainly to very poor pregnant women and children, disabled people and low-income elderly in nursing homes.

Since its implementation in 2014, about half a million Kentuckians have been added to the Medicaid rolls, most of them working.

Under Republican Gov. Matt Bevin, the state asked for a waiver of federal Medicaid rules to make changes that included, among other things, work and other "community engagement" requirements for most of the "able-bodied" individuals who gained coverage through the expansion. InsureKy has strongly opposed these changes, mainly on grounds that they would create barriers to care.

The latest entry on the timeline notes that a federal judge once again blocked Bevin's proposed changes. His administration and that of President Donald Trump have appealed the ruling. The judge struck down a similar program in Arkansas at the same hearing.

Friday, November 16, 2018

FDA cracks down on e-cigs, noting use by youth more than doubled in a year, and proposes to ban menthol in cigarettes

Centers for Disease Control and Prevention graphic
By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration proposed Thursday to ban menthol-flavored cigarettes and cigars, and restrict the sales of some flavored electronic-cigarette liquids, some flavored cigars and the removal of e-cigarettes that are marketed to youth.

The proposals are aimed at curbing teen use of e-cigarettes and follow the release of data showing that teen use of these products increased 78 percent among high-school students and 48 percent among middle-school students in the past year.

The 2018 National Youth Tobacco Survey found that 3.6 million middle and high schools students are using e-cigarettes -- up from 1.5 million last year -- with more than 3 million, or 21 percent, of the students in high school and 570,000, or nearly 5 percent of them in middle school.

"It’s clear we have a problem with access to, and appeal of these products to kids, and we’re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing in youth initiation,” Dr. Scott Gottlieb, the FDA commissioner, said in a news release.

Explaining the menthol/mint ban, Gottlieb said it's not fair to create a market difference by limiting menthol and mint flavors in e-cigarettes when they are still allowed in combustible products.

The researchers attribute the surge in e-cigarette use to the popularity of the Juul and similar devices, because they resemble USB flash drives, allowing them to be used discreetly; have a high nicotine content; and come in kid-friendly flavors.

The new restrictions would require all vaping liquids flavored with anything other than tobacco, mint or menthol be sold only in stores that have strict age-checking practices. And if sold online, the flavored liquids must be sold under more stringent age verification rules, which will be forthcoming.

Gottlieb said the FDA would proceed with a proposed regulation banning flavored cigars, would issue a proposed rule to ban menthol cigarettes and cigars and will seek to remove any e-cig products that are marketed to youth, including those using cartoon or animated characters on the packaging.

Gottlieb said the package "reflects a careful balancing of public health considerations" between adults having access to a less harmful alternative than combustible cigarettes to quit smoking and preventing teen use. "But make no mistake," he warned. "If the policy changes that we have outlined don’t reverse this epidemic, and if the manufacturers don’t do their part to help advance this cause, I’ll explore additional actions."

Michigan Education Association photo
Juul Labs, which controls more than 70 percent of the market, announced earlier this week that, among other things, it will stop selling its mango, fruit, creme and cucumber pods in convenience stores and vape shops, and would shut down its social-media promotions and keep monitoring third-party accounts.

More bad news in youth tobacco survey

The jump in e-cigarette use supports the fears of health officials who have long been concerned that e-cig use by teens will reverse the declines in overall youth tobacco use. Multiple studies show that teens who use e-cigs are more likely to transition to cigarettes.

The youth tobacco survey found that in the last year, overall tobacco-product use among high-school students increased by 38 percent, rising to 27.1 percent from 19.6 percent, and among middle-school students by 29 percent, rising to 7.2 percent from 5.6 percent.

Not only is use of the products increasing, so is the frequency of use, which could indicate development of a habit that may be hard to stop. The survey found that the number of high-school students reporting they had used e-cigs on 20 or more of the past 30 days increased from 20 percent to nearly 28 percent in the past year.

More high school students reported having used flavored e-cigarettes in the past year; that figure rose to 68 percent from 61 percent. And current use of menthol- or mint-flavored e-cigs rose to 51.2 percent from 42.3 percent. Teens and young adults have told researchers that the flavors are the primary reason for their e-cig use.

Proposals spark debate

Gottlieb is getting some push-back from conservatives, but has held firm to his commitment to stop the teen use of these products.

“My former friends in the libertarian community who think this is emblematic of nanny-state government intervention and denying adults access to legal pleasures — I hope that when they sit and think about the data we’re seeing they’re willing to accept modest speed bumps in terms of the access adults will have to these products to hopefully close off the access of these products to kids,” Gottlieb told Paige Winfield Cunningham of The Washington Post.

In a detailed story in The Wall Street Journal about menthol products and "Big Tobacco," a spokesman for Reynolds American Inc., which makes Newport, the leading U.S. menthol brand, said banning menthols could possibly result in a legal battle, and a ban would also expand the underground market for these products, Jennifer Maloney and Tom McGinty report.

Matthew L. Myers, president for the Campaign for Tobacco Free Kids said in a news release that the menthol ban would "have a greater impact in reducing tobacco use by youth and the African-American community than any regulatory measure ever undertaken by the federal government."

But Myers argued that the FDA's e-cigarette proposal doesn't go far enough, because it stops short of banning many flavors that are highly popular with young people, noting that the menthol and mint flavors used by 51 percent of teen e-cig users will still be available.

"With these flavors still widely available, it is doubtful that this plan will stem the tide of youth e-cigarette use, and it will be critical for the FDA to quickly supplement the steps announced today," Myers said. "In addition, the Juul device itself and other e-cigarettes that deliver exceptionally high levels of nicotine will continue to be sold in convenience stores and gas stations."

Bonnie Hackbarth, a spokeswoman for the Foundation for a Healthy Kentucky, noted that the proposed regulatory changes can take years to implement and that there has already been "unnecessary delays" in the e-cigarette regulations, which have allowed new products to "flourish."

"We’re heartened by the FDA’s stepped-up enforcement and by what appears to be a clear-minded attempt to balance the absolute necessity of keeping tobacco products out of the hands of kids while allowing adults who smoke access to products that may help them quit tobacco completely," she said. "But we can’t wait two more years or even another six months, only to find that e-cig flavors and easy access have hooked millions more kids to a deadly habit."

Ben Chandler, president and CEO of the foundation, said, "Flavored cigarettes were banned in 2009 largely because the colorful packaging and names appealed to youth, which is the age most smoking habits are established. The explosive growth in teen use of Juul and other pod e-cigarettes in recent months, in conjunction with research showing that most youth try flavored e-cigarettes first . . . just proves the point. Flavors are a powerful tool in the tobacco business-model toolbox that relies on addicting new customers to stay in business. Unless and until it's proven that flavored e-cigs actually do help adult smokers quit, they shouldn't be allowed on the market."

Wednesday, October 3, 2018

Cheap knockoffs of popular Juul electronic cigarettes are latest FDA target to protect teens from vaping

Cheap knock-offs of the Juul electronic cigarettes popular with teens have been showing up in stores and online, "despite a U.S. Food and Drug Administration rule banning the sale of new e-cigarette products after August 2016 without regulatory approval," Chris Kirkham reports for Reuters.

The FDA applied the August 2016 deadline to new e-cigarette products, while older devices are allowed to continue without regulatory approval until 2022.

"Start-ups and major tobacco firms have launched more than a dozen new high-nicotine devices with Juul-like designs since the FDA imposed the deadline, according to Reuters review' of the companies’ online advertisements, social media posts and public statements," Kirkham writes.

FDA Twitter graphic on efforts it's taking to shut
down the sale and marketing of e-cigarettes to minors.
Earlier this month the FDA threatened to ban Juul and four other vaping-product companies unless they took steps to prevent use by minors, but Kirkham reports that other companies have flooded the market with Juul copycats with no regulatory consequences.

The FDA told Reuters that it was looking into whether certain brands were being improperly sold and plans to take "additional action on this front very soon," focusing on products with high nicotine concentrations and flavors that apparently target youth.

Teens love these products because they are small and look like a computer USB drive, making it easy for them to hide them from parents and teachers. They also come in flavors that appeal to teens and pack a powerful nicotine punch. One Juul pod has the nicotine content of about 20 cigarettes, which is the number in a traditional pack.

Health experts have voiced concern that these high-nicotine products are creating lifelong addictions in young people and will erode decades of progress in reducing youth tobacco use.

According to the national Youth Behavioral Risk Survey, smoking among high-school students declined from 15.8 percent in 2011 to 7.6 percent in 2017, but e-cigarette use grew from 1.5 percent to 11.5 percent over the same period.

In Kentucky, traditional smoking rates and e-cigarette rates have both been on the decline since the Kentucky YBRS started asking about e-cig usage in 2015.

In 2017, about the same number of Kentucky high-school students reported using e-cigarettes as traditional ones, 14 percent. This was down from 23.4 percent and 17 percent respectively in 2015.

That said, it looks like more Kentucky teens are trying e-cigs than traditional cigarettes these days. In 2017, about 45 percent of Kentucky's high-school students said they had ever used an electronic vapor product, compared to about 41 percent who had ever smoked cigarettes.

Health officials have warned that e-cigarette use is likely much higher among teens than reported in 2017, because those numbers don't reflect the surge in Juul sales.

Anti-smoking advocates have called for Kentucky schools and locales to enact 100 percent smoke-free laws that include e-cigarettes and for state officials to tax e-cigarette devices and their liquids at the same rate as conventional tobacco products as a way to address this uptick in teen use of these products.

Another concern is that teens are using Juul and the knockoff devices to smoke marijuana because their design allows a person to replace the liquid nicotine with liquid marijuana or other concentrated marijuana products or be "hacked" to allow for such products. And because there is no odor, this allows a user to smoke it anywhere without others knowing what's inside.

Saturday, May 6, 2017

Environmental group lists Ky. among top 5 states for number of people affected by violations of safe drinking water regulations

Kentucky is ranked in the top five states for the number of people affected by health-based violations of federal drinking water laws, Erica Peterson reports for WFPL in Louisville, drawing on a report from the Natural Resources Defense Council, an environmental group.

The NRDC identified water systems with at least one reported violation of the Safe Drinking Water Act. Most of the violations involved disinfection byproducts, coliform bacteria, pathogens, nitrates, nitrites, lead and copper. The violations are estimated to affect more than 1.5 million Kentuckians.

“What our review of EPA data found is that nearly 77 million Americans are served by community water systems that have violations,” Erik Olson, NRDC health program director and co-author of the report, told Peterson. “That represents about one in four Americans.”

State officials disagreed with the non-profit’s characterization of violations. In an statement In an emailed statement to WFPL, Energy and Environment Cabinet spokesman John Mura said the safety of drinking water in the commonwealth is a top priority for regulators and that the NRDC report was not based in fact, Peterson reports.

“NRDC’s characterization of public drinking water is irresponsible and does not promote meaningful dialogue regarding the important concerns of safe drinking water and drinking water infrastructure investment,” Mura wrote.

Peterson writes that NRDC's "estimate of violations is lower than the actual figures" in an Energy and Environment Cabinet report, which shows Kentucky water systems had nearly a thousand violations of the federal Safe Drinking Water Act in 2015; and 142 of them, or 14 percent, are listed as resolved. The NRDC says this lack of enforcement is a national trend.

Statewide and county-level data that list the number of people served by each water system and the number of violations is available on the NRDC website on an interactive map. The report notes that most of the drinking water violations occur in rural areas, and "systems serving less than 500 people accounted for nearly 70 percent of all violations and a little over half of all health-based violations."

Most of Kentucky's water violations of the Combined Disinfectants and Disinfection Byproducts rule, which establishes health standards for water systems that add disinfectants, like chlorine, to their water. Adding chemicals to disinfect water has established benefits, but they can react with naturally occurring chemicals in water to create byproducts that can harm human health if not managed properly.

$500 million program administered by the U.S. Department of Agriculture has been available for infrastructure improvements for rural water systems, and was fully funded in the latest federal spending agreement that goes through September, but its future could be uncertain because President Donald Trump originally eliminated this funding in his budget proposal.

Monday, December 19, 2016

Surgeon general calls youth e-cigarette use a public health threat

image Campaign for Tobacco-Free Kids
The Office of the U.S. Surgeon General issued its first report on electronic cigarettes Dec. 8, calling them a "major public health concern" for youth. Surgeon General Vivek Murthy also announced an interactive website with information and resources for parents and youth.

 "E-cigarettes went from being rare in 2010 to now being the most common tobacco product used by our nation's youth," Murthy said during a news conference, HealthDay News reports. "This represents a staggering development in a relatively short period of time. It also threatens 50 years of hard-fought progress we have made curbing tobacco use, and it places a whole new generation at risk for addiction to nicotine."

E-cigarette use more than tripled since 2011 among middle and high school students, with more than 3 million of them current users (past 30-day use) in 2015, says the report. And after a period of relative stability from 2011 to 2013, vaping more than doubled from 2013 to 2014 among young adults between 18 and 24 years old.

In Kentucky, 41.7 percent of high school students  have ever used an electronic vapor product and 23.4 percent reported being current users ( past 30-day use) in 2015, the first year this data was collected in Kentucky on the Youth Risk Behavior Survey. As for cigarettes, 44.1 percent had ever tried cigarette smoking and 16.9 percent were current smokers.

The 2016 Monitoring the Future survey released after this report on Dec. 13 found for the first time since they started measuring e-cigarette usage, the rate "declined significantly" from 2015 to 2016, dropping from 16.3 percent to 12.5 percent among 12th graders.

"This is a promising turnaround after several surveys found a rapid rise in youth use of e-cigarettes in recent years. However, youth e-cigarette use remains disturbingly high and exceeds use of conventional cigarettes. As the Surgeon General’s report released last week concluded, e-cigarettes pose a serious threat to the health of young people," Matthew L. Myers, president of Campaign for Tobacco-Free Kids, said in a statement.

The surgeon general's report notes the dangers of nicotine on teen and young adult brains, saying it can cause addiction, reduced impulse control, deficits in attention and learning and mood disorders.

"Compared with older adults, the brain of youth and young adults is more vulnerable to the negative consequences of nicotine exposure," Murthy said in the report.

Murthy dismissed industry claims the e-cigarettes prevent youth from becoming smokers, noting the strong association between the use of tobacco products and e-cigarettes. The report says that in 2015, 58.8 percent of high school students used both combustible tobacco products and e-cigarettes.

"There is actually no evidence to support this claim when you look closely at the data," Murthy told HealthDay News.

The report raised concerns about the potential health risks from chemicals found in e-cigarette liquids, which are heated in the device to create a vapor that users inhale. It also notes that e-cigarette aerosol is not harmless 'water vapor," though it also recognizes that it has fewer toxicants than a traditional tobacco product, and that the liquids in them "can cause acute toxicity and possibly death" if consumed.

The report says that students in the 8th, 10th and 12th grades are choosing e-cigarettes over tobacco cigarettes. "In 2015, almost 7 percent of 8th graders exclusively used e-cigarettes during the previous month, alongside 10.4 percent of 10th and 12th graders. Meanwhile, conventional cigarette use occurred in 1.4 percent, just over 2 percent and slightly more than 5 percent of 8th, 10th and 12th graders, respectively," HealthDay reports.

image from the Surgeon General report
Murthy said: "The e-cigarette industry is enticing teens to try their products by flavoring the vapor to taste like candy and fruit, and by using advertising strategies that focus on celebrity endorsements, sponsorship of sports and music events, along with themes of rebellion and sex."

The report concludes with a call to action, including incorporating e-cigarettes in to all smoke-free policies; educating parents, teachers and teens about their danger; to implement and enforce regulations to decrease youth smoking; and to strengthen regulations around advertisements that appeal to youth. It also calls for more research.

In a different statement, Myers calls for the current regulations on e-cigarettes to be strengthened by prohibiting flavors and marketing that appeal to youth, while noting there is a pending proposal in Congress that would weaken the current regulation, adding: "Research has found that more than 85 percent of current youth e-cigarette users use flavored e-cigarettes, and flavors are the leading reason for youth use."

The FDA issued some long-awaited regulations on e-cigarettes earlier this year that ban e-cigarette sales to minors and require makers of the devices to submit their ingredients, among other things. But the regulation did not address the use of flavorings or advertising.

"Federal, state and local policymakers must heed this call from the Surgeon General to protect our children from becoming the next generation hooked on tobacco," American Lung Association National President and CEO Harold Wimmer said in a statement.

Wednesday, June 22, 2016

Reaction to Medicaid plan is predictably mixed; critics predict federal officials won't approve work-oriented requirements

By Melissa Patrick and Al Cross
Kentucky Health News

Reactions to Gov. Matt Bevin's plan to change Medicaid were predictably mixed, from health-reform advocates saying it is "paternalistic," too complex, removes benefits and adds costs that will create barriers to care, while leading Republicans and the Kentucky Hospital Association sang its praises.

Critics predicted that the Obama administration will reject the plan's requirements that Medicaid recipients have a job, look for one, take job training or do volunteer work.

"You just simply cannot have work requirements in the Medicaid program. It is a safety-net program," said Emily Beauregard, executive director of Kentucky Voices for Health, a coalition of groups that favor federal health reform and the embrace of it.

Judith Solomon, health-policy vice president at the liberal-leaning Center for Budget and Policy Priorities in Washington, D.C., noted that Health and Human Services Secretary Sylvia Burwell told Arkansas this year, “We cannot approve a work requirement.”

Joe Sonka of Insider Louisville wrote that an unnamed HHS official told him "the agency has been clear that states may not limit access to coverage or benefits by conditioning Medicaid eligibility on work or other activities."

The plan has several elements modeled after private insurance, and Mark Birdwhistell, Bevin's special adviser for Medicaid, said it is "commercial insurance on training wheels." That didn't set well with some critics.

"Training wheels are for kids. Right there, that struck me as an inappropriate analysis,"said Rich Seckel, executive director of the Kentucky Equal Justice Center.

"I have heard words like condescending, patronizing. Even if one doesn't use those kinds of adjectives, I do think there is perhaps an inappropriate model of envisioning people as welfare dependents when that's not really who they are and it's a little unfair to them to act on a stereotype," Seckel said. "A theory of welfare dependency kind of pervades this, and yet we know that more than more than half of the people who qualify and got covered were working people."

Seckel and others said the plan, which would seek a waiver of various federal rules, is too complex.


"People on Medicaid have a lot of responsibilities. They have a lot of things they are dealing with on a daily basis," Beauregard said. It is going to be more difficult to navigate, more difficult to keep up with all of the requirements. And it really is just going to place additional burdens on low-income working Kentuckians and their families."

She added, "Navigating the healthcare system is difficult for anyone, but certainly for people who may not be familiar with commercial insurance. I don't think that our goal should be for that people know how to use commercial insurance. I think our goal should be that people use their coverage to improve their health."

The plan removes dental care from the basic Medicaid program but allows members to qualify for it by engaging in a range of activities that could help them improve their health.

"That is the heartbreaker as far as the benefits that are in jeopardy," Seckel said. "We know how closely related that is to the rest of physical health. We know that people have seized upon that opportunity and used that benefit by the thousands. It is something that does affect your confidence in looking for jobs and acting in the workplace and maybe your hire-ability, and yet we've moved that further away and given you a bunch of things that you have to do to get it back."

KVH Chair Sheila Schuster said, "We're talking about a Medicaid expansion population that has been without coverage for years and years and years and just got it for two years, and now you are saying, 'No, you don't get to have oral health,' which is huge. We have one of the worst toothlessness problems in the country and it is very correlated with physical health."

The sharpest criticism came from Democrat Steve Beshear, who as governor expanded eligibility for Medicaid under health reform, adding more than 400,000 people to the rolls.

In a statement issued under the name of Save Kentucky Healthcare, a group he formed, Beshear said Bevin had "declared war on Kentucky’s working families" and "threatened to kick hundreds of thousands of working Kentuckians off of health care. Gov. Bevin seems woefully unaware of what Kentuckians on expanded Medicaid -- and that's construction workers, substitute teachers, nurses’ aides, farmers, our neighbors, friends and family -- do every day to support their families while still being able to take their children to the doctor."

Perhaps anticipating such criticism, Bevin's office had ready a string of quotes praising the plan.

“The Kentucky Hospital Association applauds Governor Bevin for his leadership in presenting a comprehensive plan to transform Kentucky's Medicaid program to achieve better health outcomes for Kentuckians, while also focusing on its financial sustainability," President and CEO Michael Rust was quoted as saying. “We look forward to working with the Bevin administration in helping to implement this innovative plan.”

Bevin's office also quoted several leading Republicans, including state Senate President Robert Stivers of Manchester, whose district has a large Medicaid population: "I am glad to see Governor Bevin and his administration putting an emphasis on personal responsibility with regard to Medicaid expansion. These are some ideas we have been talking about in the Senate for several years. I agree that the idea of making individuals have some 'skin in the game' will make for a more sustainable and better health-care system for Kentucky."

The Foundation for a Healthy Kentucky issued a statement from President and CEO Susan Zepeda, which said in part: "There are areas to applaud in the proposal, including aligning Managed Care Organization practices for greater efficiency, incentives for evidence-based healthy behaviors such as quitting smoking and obtaining a health risk assessment, expansion of presumptive eligibility sites (including local health departments), and commitment to drug use disorder and mental health services."

"The proposal also raises concerns, including the exclusion of dental and vision benefits in the standard benefits package, anticipated significant drops in Medicaid enrollment, elimination of retroactive eligibility and re-enrollment requirements and penalties for those who fail to pay mandated premiums."

Bevin offers 'transformative' Medicaid program with premiums, incentives, work-oriented requirements; expansion at stake

"It's not about the money for the premiums, it's about the learning
experience." --Mark Birdwhistell, Medicaid adviser to Gov. Bevin

(Lexington Herald-Leader photo by Charles Bertram)
By Al Cross and Melissa Patrick
Kentucky Health News

FRANKFORT, Ky. -- Most Kentucky Medicaid recipients would have to pay premiums of $1 to $15 a month, and be more actively involved in their health care, under Republican Gov. Matt Bevin's proposal to maintain his Democratic predecessor's expansion of the program.

If federal officials approve, the program would no longer include some benefits, such as dental and vision care. However, recipients could gain access to those benefits, as well as non-prescription drugs and gym-membership subsidies, by enrolling in job training, volunteer work or health-related classes.

The changes would apply only to able-bodied adults, not pregnant women, the disabled or those deemed "medically frail." Working-age adult members without dependents would be required to participate in volunteer work, have a job, look for one or take job training, on a gradually increasing scale, phased in by county.

At a 50-minute press conference in the Capitol rotunda, Bevin said the program would be "transformative."

"There is nothing good or healthy or productive, long-term for the individual or for society as a whole, that comes from able-bodied, working-age men and women with no expectation of their involvement and no opportunity for that involvement," he said. "So we are providing an expectation and an opportunity and a reward. . . . When they get out there and they get engaged and they start to realize the value that they add, it will change people's lives."

The proposal also asks for Medicaid funding of inpatient substance-abuse treatment, something Bevin said no other state has done, in an effort to address the state's growing drug-abuse problems. This would be a demonstration project limited to 10 to 20 "high risk" counties that have not been chosen.

Bevin's proposal says it "represents the terms under which the Commonwealth will continue Medicaid expansion," and he said that if federal officials don't approve it, he would end the expansion, which provides largely free health care for about 400,000 Kentuckians.

But he said he was confident that federal officials would approve the request, which seeks a waiver of a wide range of Medicaid rules, because he and his aides have been in frequent contact with the Center for Medicare and Medicaid Services and its overseer, Health and Human Services Secretary Sylvia Burwell.

He said nothing in the proposal should be a surprise. “There’s nothing we’re asking them to do that has not been done or is not a stated goal of theirs in other programs,” he said. However, in granting some waivers, CMS has said it would not approve them in other states.

Bevin said during his campaign last year that the expansion was unsustainable, but his plan estimates a modest savings of $300 million to Kentucky taxpayers over the next five years, most of that apparently from tightening up on the managed-care organizations that deal directly with Medicaid members.

"This has been the most lucrative state in America for MCOs to operate," with profit margins four to five times the national average, Bevin said. A recent report said MCOs in Kentucky turned an aggregate profit of 11.3 percent, much higher than any of the 38 other states with managed care.

The federal government is paying all bills for Medicaid expansion enrollees through this year. Next year the state would pay 5 percent, rising in annual steps to the federal health-reform law's limit of 10 percent in 2020. The estimated cost of the state share in the two-year budget that begins July 1 is $257 million.

Bevin said saving money in near-term budgets is not as important as the long-term savings and quality-of-life improvements that can come from improving the health status of one of America's least healthy states.

"It's important to make sure that we have something that, above all else, creates better health outcomes," he said, citing some of Kentucky's poor health statistics. "Number two, we want to familiarize participants with the commercial insurance program" and be more engaged in their communities.

Proposed premiums for first two years. Those above FPL
would pay $22.50 in Year 3, $30 in Year 4, $37.50 afterward.
The premiums would be based on income levels, designed to be less than 2 percent of income, and could be paid by third parties. For non-payment, members above the federal poverty line would be dropped for six months but could re-enter earlier by bringing their payments up to date and taking a financial or health literacy course. Those below the poverty line would incur lesser penalties.

Bevin's proposal would eliminate $3 co-payments for doctor visits and other routine services. Advocates for the poor had said they liked premiums better, because they can be budgeted.

Bevin acknowledged that it would probably cost more to collect the premiums than they would generate, but he said "The savings come from having people who are healthier, who are more engaged. . . . It's not about trying to save money. The money will come from doing the right thing. Better, healthier outcomes result in cost savings on health expenditures."

Medicaid would have a $1,000 deductible, but it would be paid from a state-funded account. At the end of each year, half of the unused amount would be transferred into the recipient's "My Rewards" account. That account would be built by enrollment in classes, job training or volunteer work and could be used to buy additional benefits.

"The deductible account and the My Rewards account empower individuals to be active consumers of health care and make cost-conscious decisions, while simultaneously providing incentives for members to improve their health and be active members of the community," the proposal says.

If Medicaid members are employed and their employer offers health insurance, they and their children would be required to go on it after one year. The state would continue to cover services that are covered by Medicaid but not by an employer's plan.

The plan also calls for a specific enrollment period for Medicaid, which now accepts enrollees year-round. It says making Medicaid more like private insurance will help the many people whose incomes fluctuate, making them eligible for Medicaid one year and federally subsidized health insurance the next.

The proposal opens a 30-day comment period, in which the state will hold three public hearings: in Bowling Green June 28, Frankfort June 29 and Hazard July 6. The administration hopes to finalize and submit its proposal to CMS around Aug. 1 and get approval by Sept. 30, said Mark Birdwhistell, a University of Kentucky health-care vice president who is Bevin's special adviser for Medicaid.