New state health laws are in effect; one to regulate herbal drug kratom is in limbo due to lack of funding, Beshear says

Kentucky Capitol (Wikipedia photo)

By Melissa Patrick
Kentucky Health News

A number of new state health laws took effect July 15, ranging from measures on maternal health to improved access to a commonly used allergy medication.

The General Assembly passed more than 200 bills during its 60-day session. They become law 90 days after adjournment of the legislature unless they have a defined effective date, are general appropriation bills, or are passed with an emergency clause. This year, the effective date was July 15.

Some of the health measures that are now law are:

Health Care Liability: House Bill 159, sponsored by Rep. Patrick Flannery, R-Olive Hill, protects health-care providers from criminal liability when a medical error harms a patient. The bill does not apply to harm resulting from gross negligence or wanton, willful, malicious or intentional misconduct.

Kratom: HB 293, sponsored by Rep. Kim Moser, R-Taylor Mill, aims to regulate kratom, an herbal drug frequently sold online and in convenience stores. The bill prohibits sales to people under 21 and provides guidelines for manufacturing and labeling the product.

This bill was included in a list of 22 laws mentioned in an April letter from Gov. Andy Beshear to legislators saying there is a lack of funding to implement them, so that puts this new law in limbo, Liam Niemeyer reports for the Kentucky Lantern.

Maternal health: Senate Bill 74, sponsored by Sen. Shelley Funke Frommeyer, R-Alexandria, aims to support maternal and infant health and reduce the high mortality rate for mothers in Kentucky. Several sections of the bill took effect July 15, including one that will provide more information about breastfeeding and safe sleep to at-risk parents. Others establish a state maternal-fatality review team and require Medicaid to cover lactation consulting, breastfeeding equipment, and in-home and telehealth services. The bill also requires state health officials to compile an annual report about the number and types of delivery procedures performed at each hospital. Other sections of the bill will not take effect until 2025. This bill includes the “Momnibus” bill, which was originally filed as HB10 by Moser.

Medical cannabis: HB 829, sponsored by Rep. Jason Nemes, R-Middletown, updates some aspects of Kentucky’s upcoming medical cannabis program. It allows schools to ban medical cannabis from their campuses and allow local governments to apply a small fee to the program, among other changes. Three sections of the bill related to applications for business licenses, state enforcement and patient pamphlets will not take effect until 2025.

Pseudoephedrine: HB 386, sponsored by Rep. Robert Duvall, R-Bowling Green, eases purchase limits on pseudoephedrine to help people with chronic allergies legally obtain enough of the medication to meet their medical needs.

Vaping in schools: HB 142, sponsored by Rep. Mark Hart, R-Falmouth, bans all tobacco, alternative nicotine and vapor products in Kentucky public schools. It also requires school districts to adopt disciplinary procedures for students who violate the bans.

Veteran suicide prevention: Under HB 30, sponsored by Rep. Michael Meredith, R-Oakland, the Kentucky Department of Veterans Affairs will create a suicide prevention program for service members, veterans and their families.

Youth medical records: HB 174, sponsored by Rep. Rebecca Raymer, R-Morgantown, stipulates that parents have access to their child’s medical records. Prior to this law, children ages 13 and older had to sign a waiver for parents to have access.

Alzheimer's education: HB 459, sponsored by Moser, requires advanced practice registered nurses and physician assistants who primarily work with Kentuckians ages 50 years and older to undergo continuing education related to the detection and treatment of Alzheimer’s and other forms of dementia. This language was added from SB 211, sponsored by Sen. Stephen Meredith, R-Leitchfield, in the final days of the session. The bill also involves the APRN national certification exam and Kentucky Board of Nursing appointments.

News releases from the Legislative Research Commission contributed to this story.

Bills to become law on vaping, pharmacy reform, vaccinations, drugs, at-home blood testing, coverage of cancer screening, more

Kentucky State Capitol (Photo via Wikipedia)

By Melissa Patrick
Kentucky Health News

In its 2024 session the Kentucky General Assembly has passed dozens of health-related bills that address a range of topics. With one day left in the session, here are some of them: 

Vaping: House Bill 11 limits legal sale of vaping products to those approved by the U.S. Food and Drug Administration. It also creates a database of retailers that sell the products and sets fines for retailers, manufacturers and wholesalers who violate the law.

HB 142 requires school districts to adopt specific policies that penalize students for possession of "alternative nicotine products, tobacco products or vapor products" and report nicotine-related incidents to the state Department of Education. Changes in the Senate, accepted by the House, allow schools and their governing bodies to apply for grants related to nicotine usage and remove the mandate that schools suspend students with a third possession violation. 

Pharmacy reform: Senate Bill 188 changes laws governing commercial pharmacy benefit managers, with requirements aimed at saving the state's independent pharmacies from closing.  It provides for dispensing fees, bans PBMs from forcing patients to get their drugs through mail order, and keeps them from steering patients to pharmacies that they own.

The bill, sponsored by Sen. Max Wise, R-Campbellsville, also prohibits a PBM from reimbursing a pharmacy that it owns at a higher rate than a community pharmacy, or from keeping a community pharmacy from filling a 90-day prescription for a maintenance drug. And a PBM will not be able to penalize a community pharmacy from sharing information with a patient on the cheapest option to pay for their medications.

Reducing barriers to screening

Cancer detection: HB 52 will require health-insurance plans to cover all preventive cancer screenings and tests that are consistent with nationally recognized clinical practice guidelines without requiring patients to pay any cost-sharing requirements, including a deductible charge for the services.

The sponsor, Rep. Deanna Frazier Gordon, a Republican from Richmond, told Kentucky Health News in February that the cost for screenings is often a barrier for people who often don't get screened because they don't have symptoms.

HB 115 will eliminate co-payments and cost-sharing requirements for high-risk individuals who need follow-up diagnostic imaging to rule out breast cancer. Currently, screening mammograms are covered by insurance, but follow-up exams are often not. 

“Thousands of Kentuckians require diagnostic and supplemental breast imaging every year, yet many forgo them due to out-of-pocket costs. Not any more,"  Molly Guthrie, vice president of policy and advocacy at the breast-cancer foundation Susan G. Komen, said in a news release. "This life-saving legislation means they will now receive the breast imaging they require, leading to an earlier breast cancer diagnosis and often better health outcomes."

Vaccines and drugs  

Vaccinations: HB 274 will allow Kentucky pharmacists to order and administer vaccinations to children as young as 5. The state's routine vaccination rates for kindergarteners remain below pre-pandemic levels.

Pseudoephedrine: HB 386 will raise the annual purchase limits on pseudoephedrine to help people with chronic allergies legally obtain enough of the medication to meet their needs. The bill changes the current 24-gram annual limit to an 86.4 grams, and remove the limit on the number of packages per transaction, said sponsor Robert Duvall, R-Bowling Green.

Kratom: HB 293 will regulate kratom, a natural herbal supplement that is not currently regulated. It is often used for anxiety, pain, PTSD and opioid withdrawal. The bill defines kratom, prohibits sales to people under 21, puts it behind the counter and provides guidelines for manufacturing and labeling. It also says federal law supersedes state law on the matter. 

Blood thinners: HB 31 allows Medicaid patients in Kentucky who are on blood thinners to use at-home machines to test their blood. Patients on some blood thinners, like warfarin, now require a weekly trip to the doctor's office for blood work that looks at how fast their blood clots.

Amanda Crabtree, a registered nurse at University of Kentucky Chandler Hospital, told WKYT-TV that she hopes that other states will follow Kentucky's example in this legislation. Crabtree said she expects that Medicaid patients could receive their at-home machines as soon as this summer.

Health-care business issues

Provider liability: HB 159 will protect health-care providers from criminal liability when a medical error harms a patient unless the harm results from gross negligence or wanton, willful, malicious or intentional misconduct. 

This effort was led by the Kentucky Nurses Association, which said the bill "will prevent health-care professionals from being charged criminally for making a medical error; that makes it good for nurses and nursing, and puts Kentucky at the forefront of developing laws to protect health-care workers." 

Workplace violence: HB 194 extends to contract workers, such as travel nurses, the law that makes violence against health-care workers a third-degree assault. It also extends this protection, now limited to hospitals, to contract employees at health clinics, doctor offices, dental offices and long-term care facilities. 

Sepsis: HB 477 establishes diagnostic criteria for sepsis allow hospitals to preserve current rules used for reimbursement of sepsis care, which allow payment when it is detected early, instead of only allowing reimbursement after organ failure occurs. 

"We know that if sepsis is caught early, the likelihood of survival is great," Jim Musser, vice president for policy with the Kentucky Hospital Association, told Kentucky Health News in March. "But for every hour that we wait, the chance of mortality increases by 7 percent." In sepsis, "The body responds improperly to an infection," says the Mayo Clinic. "Sepsis may progress to septic shock . . . When the damage is severe, it can lead to death."

Other health bills that passed

Youth medical records: HB 174 allows parents have access to their child’s medical records until they turn 18. Right now, children 13 and older must sign a waiver for parents to have access to them. HB 174 also updates the state's Medical Orders for Scope of Treatment form, which defines a person's end-of-life wishes.

Veteran suicide prevention: HB 30 calls on the state Department of Veterans Affairs to create a suicide prevention program for service members, veterans and their families.

Stuttering: SB 111 eliminates some insurance coverage limits on speech therapy for stuttering. It was promoted by former UK basketball star Michael Kidd-Gilchrist, who has overcome stuttering.

Medicaid: SB 71 is designed to keep people from coming to Kentucky to establish residence so that they can sign up for drug treatment to be paid for by Medicaid. One challenge resulting from this practice, according to Rep. Shane Baker, R-Somerset, is that when they leave the program, they are often homeless. 

SB 280 will allow Level II trauma centers that partner with a  university to get the university-hospital rate for services delivered as part of that residency program.

Taxpayers pay malpractice awards involving federally qualified health centers; in Kentucky, $7.7 million was paid in 2018-2021

By Melissa Patrick and Al Cross

Kentucky Health News

Federally qualified health centers, or FQHCs, are very important parts of the health-care delivery system for the poor in Kentucky, largely because they can't turn anyone away and charge patients based on their income. In return, they get an annual grant and higher reimbursements from Medicaid and Medicare — and, for the vast majority of clinics, financial immunity from malpractice lawsuits.

The centers can still be sued for malpractice, but the federal government becomes the defendant and pays any settlements or judgments. That little-known aspect of FQHCs is examined in a story by Phil Galweitz and Bram Sable-Smith of Kaiser Health News, along with a list of the 485 payouts made on the centers' behalf from 2018 through 2021, totaling $410 million. 

Over that four years, Kentucky had nine payouts totaling $7,718,629, made on behalf of six health centers. Most of that, $5 million, was to settle a claim involving Sterling Health Solutions, based in Mount Sterling. The second largest, $2,082,337, was a judgment involving Big Sandy Health Care of Prestonsburg.

Both cases involved women's health care, which is often the object of high-dollar malpractice claims. Doctors say the cost and availability of malpractice insurance discourages opening such practices, especially in rural areas. 

Screenshot of Kaiser Health News' Kentucky list, adapted by Ky. Health News

"Malpractice lawsuits are a risk for all health-care providers and are just one barometer of quality of care," Kaiser Health News says. "The settlements and court judgments against the health centers don’t measure the clinics’ overall performance."

The clinics fill many needs. "Nearly half of the centers’ patients are covered by Medicaid, and 20 percent are uninsured," Kaiser reports. "Even lawyers who have sued on behalf of health center patients acknowledge the importance of the facilities. Rhode Island plaintiff attorney Amato DeLuca said that the health centers serve a vital role in the health industry and that he had found “a lot of really wonderful, extraordinarily capable people that do a really good job” at the centers. Yet everyone must be held accountable for mistakes, DeLuca said."

The biggest payments

Kentucky's biggest payment in 2018-21, $5 million, settled a $42 million claim by Rebecca Anderson and Randy Brooks of Montgomery County that their son, known in court documents as G.B., suffered severe and permanent injuries during and after his birth in 2015 because Dr. Byram Ratliff of Sterling Health Solutions failed to respond to fetal distress as evidenced on the fetal heart monitor strips prior to delivery. "Dr. Ratliff failed to institute prompt and proper medical care resulting in severe permanent injury," they alleged. "As a result, G.B. will require a lifetime of medical care and treatment."

A bench trial of the case was recessed for negotiations that resulted in a settlement, comprising $2.5 million of "upfront cash" to be held in escrow until all liens and claims in the case were resolved, and a $2.5 million trust fund for future medical care. The plaintiff's attorneys were awarded case expenses of $281,873 and fees of $1,250,000. Attorney fees in such cases are limited to 25% of the award. 

A document titled "Stipulation for compromise settlement and release" says the settlement is in no way an admission of "liability or fault."

Big Sandy Health Care was connected to the second largest amount paid in Kentucky during the four-year period, $2,082,337. This case was a medical negligence claim by Lisa Ann Crispen against Dr. Joanna Santiesteban, Dr. Enrico Ascani and Big Sandy Health Care for failure to diagnose uterine cancer. 

After a bench trial, Chief U.S. District Judge Karen Caldwell awarded the judgment, writing, "Chrispen proved by a preponderance of the evidence that Big Sandy's negligence in evaluating, diagnosing, and treating Chrispen's cancer caused her to suffer past and future lost wages, past and future medical expenses, past and future physical pain and suffering, and past and future emotional pain and suffering." 

The Kaiser list shows that another federal payment involving Big Sandy Health Care was made during the four-year period, in 2018 for $35,292.

Burkesville-based Cumberland Family Medical Centers was involved in the third largest payment, $225,000. This was in a case filed by Judy and John Courtier of Monroe County, alleging that the Tompkinsville center incorrectly transcribed a prescription from a rheumatologist, resulting in Judy Courtier taking a toxic amount of methotrexate (2.5 milligrams twice a day instead of two 2.5 milligrams tablets once a week), causing conditions that required hospitalization. The parties reached a settlement in October 2018.

The Kaiser list shows another federal payment involving Cumberland Family Medical Centers was made during the four-year period, in fiscal 2019 for $26,000.

The chain of clinics is Kentucky's largest federally qualified health center. It had gross revenues of $83 million in 2019, according to the Form 990 for tax-exempt nonprofits that it filed with the Internal Revenue Service. Kentucky nonprofits must also file the forms with the state attorney general's office.

Sterling reported 2019 revenues of $13.6 million. The latest filing at the attorney general's office from Big Sandy, for 2016, showed revenues of $19.5 million.

Family Health Centers of Louisville, which had 2019 revenues of $45 million, was involved in the fourth largest payment in 2018-21, $200,000. It settled a claim by Carolyn Boerste alleging failure to tell her that a radiology report noted she had a 12-inch-by-12-inch laparotomy sponge that snaked through her small intestine for 19 months before it was removed. 

Kentucky Health News offered the four health centers the opportunity to comment, but none did.

Other Kentucky payments in the four-year period involved Grace Community Health Center of Corbin, also called Grace Health; and Fairview Community Health Center of Bowling Green.

Why do taxpayers pay these settlements? 

To win congressional protection in the 1990s, federally qualified health centers "argued their revenues were limited and malpractice insurance would divert money that could better be used for patient care," Kaiser Health News reports. About 86% of the 1,375 clinics have this protection, which comes with a list of requirements. 

To get the protection, a clinic "must have quality- improvement and risk-management programs and must show regulators that they’ve reviewed the professional credentials, malpractice claims, and license status of their physicians and other clinicians," Kaiser reports. "Ben Money, a senior vice president for the National Association of Community Health Centers, said the process improves care and directs scarce operating dollars toward the needs of patients, versus costly malpractice coverage."

Patients who want to claim malpractice by a health center must file a claim with the U.S. Department of Health and Human Services, which can make a settlement offer or deny the claim. "If the claim is denied or not settled, or a six-month review period expires, the patient may sue in federal court under the Federal Tort Claims Act," Kaiser reports.

Here's a map showing the centers' locations in Kentucky (click on it to enlarge):

Map from the Kentucky Primary Care Association; to enlarge any image, click on it.

Bevin and Trump agencies argue work requirements in other public-assistance programs pave the way for likewise in Medicaid

The administrations of President Trump and Gov. Matt Bevin argue that Kentucky's proposed Medicaid program, which includes work and other "community engagement" requirements, should be upheld because the new rules would be no different than what is already required of people who receive federally funded food assistance, Darla Carter reports for Insider Louisville.

In briefs filed last week with the U.S. Court of Appeals for the District of Columbia, they maintain that Health and Human Services Secretary Alex Azar used proper judgment to approve the state’s new Medicaid plan, which called for a waiver of the traditional Medicaid rules to require some "able-bodied," non-elderly Medicaid recipients to work or participate in a list of approved community engagement activities 20 hours a week to get their health benefits.

The official name for the state's new Medicaid plan under the Section 1115 waiver is Kentucky HEALTH, for "Helping to Engage and Achieve Long Term Health." The administrations liken the work rules to those already in use by food-aid programs such as the Supplemental Nutrition Assistance Program, formerly food stamps, and Temporary Assistance for Needy Families (TANF), generally known as "welfare."

“There is no reason why a Section 1115 waiver cannot test a community-engagement program in Medicaid, given that SNAP and TANF already have work-oriented programs,” the state argues in its brief. “Surely Section 1115 allows the secretary to test whether long-standing work-oriented programs from other public-assistance programs will work in Medicaid."

Carter reports in detail about the brief, which is part of an appeal from the March decision by District Judge James Boasberg that stopped similar plans proposed by Kentucky and Arkansas. This was the second time that Boasberg had vacated the federally approved plan and sent it back to the Department of Health and Human Services for further review. He said both times that HHS had not sufficiently considered the state's projection that its Medicaid rolls would have 95,000 fewer people in five years with the rules than without them, in large measure for failing to follow the rules.

The state takes issue with Boasberg's criticism that Azar failed to estimate the number of Medicaid recipients who would shift to other coverage because of Kentucky HEALTH, saying Azar is not required to know results in advance because that would defeat the purpose of the demonstration.

The new filing argues that Boasberg "was influenced by portrayals of the food-aid work requirements being counterproductive to low-income people, making him skeptical that a demonstration project like Kentucky HEALTH could lead to employment," but Congress disagrees, Carter reports.

The Kentucky Center for Economic Policy and Kentucky Voices for Health have reported that since last year, about 21,400 people have lost their SNAP benefits because of a work requirement in Kentucky.

Samuel Brooke, a deputy legal director at the Southern Poverty Law Center, which represented the 16 Kentucky Medicaid recipients who filed suit against Bevin's plan, said May 22: “When the waiver briefly went into effect in Arkansas, everyone saw the devastating effect it could have – thousands lost coverage in a matter of months. We are confident the appeals courts will similarly agree with the district court that the Medicaid program is designed to provide access to health care, and efforts to undercut that are contrary to Congress’s intent.”

In addition to arguing that Azar was within the scope of what is allowed and that his rationale was "careful and well-reasoned," the state says he was right in concluding that Kentucky HEALTH is likely to help sustain the state’s Medicaid program. Bevin issued an executive order last year that ends the expansion of Medicaid to people who earn up to 138% of the federal poverty line six months after any final court decision that blocks his plan.

Is this the year Ky. lawmakers throw tobacco and e-cigarettes out of schools? Advocates see more hope, and rally for their bill

Rep. Kim Moser spoke at the tobacco-free-schools rally.
(Photo by Charles Bertram, Lexington Herald-Leader)

At a Jan. 22 rally in the state Capitol, students, educators and health advocates asked Kentucky lawmakers to pass a law to make all schools in the state 100 percent free of tobacco and electronic cigarettes.

Terry Brooks, executive director of Kentucky Youth Advocates, said passing such a law should be a "no-brainer" for state elected officials who are committed to kids.

"Many issues that confront the Kentucky General Assembly are complex and complicated; the issue of tobacco-free schools is not one of them," Brooks said in a news release."Every young person deserves protections against exposure to secondhand smoke and to the dangerously high nicotine levels of e-cigarettes. Strong school campus policies on a statewide basis deliver those kinds of safeguards for all kids in every school."

Kentucky's high-school students smoke at a much higher rate than their peers across the nation, 14.3 percent compared to 8.8 percent. Almost as many, 14.1 percent, use e-cigarettes, which is a bit above the 13.2 percent nationally, according to the 2017 Youth Risk Behavior Survey, a national poll.

Health experts have warned that the e-cigarette rates are probably higher now because Juul sales have surged since the survey. A federal report released in November found that in 2018, one in five high school students and one in 20 middle school students are now using e-cigarettes in the U.S, representing a a 78 percent increase for high schoolers and a 48 percent increase among middle schooers in less than a year.

Passing a statwide tobacco-free school law could stop nearly one in three Kentucky students from smoking, according to the advocates. "This is an issue that should move ahead with speed, ease and consensus," Brooks said. "There is no excuse or rationale for any other outcome."

Two bills have been filed to make all Kentucky schools tobacco-free: House Bill 11, sponsored by Rep. Kimberly Moser, R-Taylor Mill, and Senate Bill 27, sponsored by Sen. Ralph Alvarado, R-Winchester and co-sponsored by Sen. Stephen Meredith, R-Leitchfield. Both would bar the use of tobacco products, including e-cigarettes, on all school properties and at all school events that are on school-owned property.

"Tobacco-free schools policies set a healthy example for students by de-normalizing tobacco use at school, where our children and teens spend a third of their waking hours," said Moser. "In one Juul we have about the same amount of nicotine as one pack of cigarettes. That is crazy."

Alvarado, a physician, said, "Most tobacco use starts while kids are still school-aged, a time when their brains are still developing and nicotine can hinder that development and cause lasting damage."

He added, “The tobacco-free schools bill we’ve introduced is all about prevention,” stating that 90 percent of tobacco use starts before the age of 18, reports The Lane Report.

Fewer than half of Kentucky school districts have enacted such policies. As of July, 72 of the 173 districts had adopted 100 percent tobacco-free school policies, covering 734 schools and 57 percent of the state's students. Federal law only prohibits smoking inside schools that receive federal funding.

In past legislative sessions, bills to require all school properties and school events to be tobacco-free have gained little to no traction. Two were introduced in the last session, but were not called up in the legislature's education committees. The Senate passed one in 2017, but it died in the House.

Prospects look better this year. The House version of the bill has already been posted in the House Health and Family Services Committee, which Moser chairs. The bill also has the "newfound support" of the The Kentucky School Boards Association and the Kentucky Association of School Superintendents, says the news release.

"We have cautiously waited to see how effective and workable these policies have been in the numerous districts that have adopted them. We believe the policies are working because enforcement has been crafted to fit each district's needs, an approach which will continue with HB 11 and SB 27," Kerri Schelling, executive director of the school boards association, said in the release.

Such a bill also has the support of 87 percent of Kentucky adults, according to the most recent Kentucky Health Issues Poll, which has shown consistent support for such policies since 2013.

And it also has the lobbying support of the Coalition for a Smoke-Free Tomorrow, which is made up of about 180 organizations across the state. The coalition has made a statewide tobacco-free school law its highest priority this year, says the release.

Ben Chandler, the coalition's chair and the president and CEO of the Foundation for a Healthy Kentucky, stressed that it's important to pass this law now to recover the progress that has been made in reducing teen tobacco use that is steadily being lost because of the explosion in teen vaping.

"We're coming up on half of Kentucky's school districts that already have enacted these policies to reduce tobacco use by teens and to protect them from the significant health dangers of secondhand smoke and e-cigarette aerosol," he said in the release. "Now is the time to extend those protections statewide, before we lose any more ground."

16 Kentuckians on Medicaid sue Trump administration again over re-approved Medicaid program, say it still violates federal law

By Melissa Patrick
Kentucky Health News

Kentucky's new Medicaid program, which includes controversial work and community engagement requirements was recently re-approved by the Trump administration after a judge rejected it. Now the plan is back in federal court after 16 Kentucky Medicaid enrollees filed an amended complaint to the original class-action lawsuit.

The 88-page amendment, filed Monday night, says nothing of substance was changed when federal officials re-approved the plan, so many of its new requirements continue to violate federal law.

The plan website: https://kentuckyhealth.ky.gov/Pages/FAQ.aspx

The state's new program, called Kentucky HEALTH for Helping to Engage and Achieve Long Term Health, includes, among other things, work or other community engagement requirements; monthly reporting; lock out periods for failure to comply; and income-based premiums. It is set to launch April 1.

Just days before the program was originally set to roll out in July, U.S. District Judge James Boasberg of Washington, D.C. vacated it and sent it back to the U.S. Department of Health and Human Services for review, ruling that, among other things, HHS Secretary Alex Azar had not fully considered the state's projection that in five years the Medicaid rolls would have 95,000 fewer people with the plan than without it.

Boasberg found the approval of Kentucky HEALTH "arbitrary and capricious" because the federal government had "never adequately considered whether Kentucky HEALTH would, in fact, help the state furnish medical assistance to its citizens, a central objective of Medicaid."

The amended lawsuit has been filed in Boasberg's court, despite Gov. Matt Bevin's efforts to have it moved to Kentucky. Defendants and interveners have until Jan. 28 to respond, including motions for dismissal or summary judgment.

The Southern Poverty Law Center is among the counsel for the plaintiffs. Samuel Brooke, the center's deputy legal director, said in a news release, “The Trump administration’s desire to explode Medicaid and transform it into a work program seems to have no limits. After being declared arbitrary and capricious last year, the administration has now issued a virtually identical re-approval letter; it should face a similar fate and be declared illegal,"

The plaintiffs' lawyers argue that the work and community-engagement requirements, income-based premiums, cost-sharing for non-emergency use of emergency rooms, lockout penalties for violators, removal of retroactive coverage, and removal of non-emergency medical transportation -- and Kentucky HEALTH as a whole -- don't promote the objectives of the 54-year-old Medicaid program.

They argue that each of those measures is "categorically outside the scope" of what is allowed under the guidelines for a waiver of the Medicaid rules; that these new requirements don't qualify as "experimental, pilot or demonstration project(s), nor (are they) likely to promote the objectives of the Medicaid Act;" and that the federal government has "relied on factors which Congress has not intended them to consider, entirely failed to consider several important aspects of the problem, and offered an explanation for their decision that runs counter to the evidence."

In addition, the lawyers claim that a Jan. 11, 2018 letter from the Centers for Medicare and Medicaid Services to all states' Medicaid directors. laying out a path for approval of work and community-engagement requirements under a waiver of the original Medicaid rules, should not have been issued without a formal hearing process.

The suit also notes that the state has said it seeks to "comprehensively transform Medicaid" through Kentucky HEALTH, that the director of CMS has stated the need to "fundamentally transform Medicaid" and the Trump administration has "repeatedly expressed its hostility to the Affordable Care Act and its desire to undermine its operation," violating the constitutional requirement that the president "take care that the laws be faithfully executed." The suit says "The power to 'transform' a congressional program is a legislative power vested in Congress."

The Bevin administration has long said the goal of Kentucky HEALTH is not to kick people off of Medicaid, but to empower individuals to improve their health and help them shift to employer-sponsored coverage, and to ensure the program's financial stability. The state has estimated that it would save about $2.4 billion over five years.

Adam Meier, secretary of the state Cabinet for Health and Family Services, said in an e-mail, “The cabinet is not surprised by the refiling and will continue to work toward implementation of the Kentucky HEALTH waiver. Kentuckians, and specifically our Medicaid members, deserve a Medicaid program that will improve health outcomes and provide paths for employability, long-term stability, and future success while also ensuring the long-term sustainability of Medicaid for those who need it most."

The lawyers disagree, saying in their preliminary statement: "Purporting to invoke a narrow statutory waiver authority that allows experimental projects 'likely to assist in promoting the objectives' of the Medicaid Act, the [HHS] secretary is working to effectively rewrite the Medicaid statute, ignoring congressional restrictions, overturning a half century of administrative practice, and threatening irreparable harm to the health and welfare of the poorest and most vulnerable in our country."

Medicaid covers 1.4 million Kentuckians, including almost half of a million under the previous administration's 2014 expansion of eligibility to people with incomes up to 138 percent of the federal poverty level.

Only four of the 16 Medicaid enrollees listed on the amended complaint were part of the original lawsuit; 12 new plaintiffs have been added. The amendment describes each one's situation in detail. They are represented by the National Health Law Program, a public-interest law firm; the Kentucky Equal Justice Center; and the Southern Poverty Law Center.

The defendants are HHS, CMS and their top officials. It also names the Commonwealth of Kentucky, which filed an unopposed motion for intervention, which was granted on March 30, 2018, as a "defendant-intervenor."

Boasberg's original 58-page decision is at: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0152-74.

Congress agrees on bipartisan opioid package

Congress has agreed on a comprehensive package to address the opioid epidemic, which includes both law-enforcement and public-health measures. President Trump is expected to sign it.

The 653-page bill has a provision to fight importation of fentanyl through the mail, one that allows more health-care providers to prescribe medication for opioid addiction, and another to make it easier for Medicaid recipients to get inpatient care for substance abuse over the next five years.

“While there is more work to be done, this bipartisan legislation takes an important step forward and will save lives,” a group of Republican and Democratic committee leaders said in a statement.

Opioid overdoses were responsible for nearly 50,000 U.S. deaths last year, 1,565 in Kentucky.

One of the most expensive items in the new law is the partial removal of a decades-old federal rule that prevented states from using federal Medicaid dollars on inpatient addiction treatment facilities with more than 16 beds, called the IMD exclusion (for "institution for mental disease").

For the next five years, the new law allows states to amend their Medicaid programs to obtain federal funds to cover up to 30 days of residential treatment for individuals receiving substance-abuse treatment per calendar year.

Mental-health advocates have said this provision doesn't go far enough because it doesn't cover treatment for mental illness that isn't related to substance use. Others have voiced concerns that the relaxation of the exclusion will divert money away from other community-based programs.

Some addiction specialist are also concerned that it will create a shift to these inpatient facilities and away from longer-term outpatient programs that focus on medication-assisted treatments, which is the gold standard for treating opioid addiction. "Many residential programs for opioid addiction still don't offer such treatment as part of their protocol, and the bill does nothing to address that," Abby Goodnough of the New York Times reports.

The package also will permanently allow nurse practitioners and physician assistants to prescribe buprenorphine, an anti-addiction medication that requires a special license. It also allows nurse anesthetists, nurse midwives and clinical nurse specialists to prescribe buprenorphine for a trial period of five years.

It also includes a provision to help stop the flow of illicit opioids into the country by mail, especially synthetic fentanyl. Goodnough writes, "It will require the United States Postal Service to start collecting information on international mail shipments, just as private carriers like FedEx and DHL already have to do. By the end of this year, the Postal Service will need to provide the name and address of the sender and the contents of the package, as described by the sender, for at least 70 percent of all international packages, including all of those from China. It will have to provide the information on all such shipments by the end of 2020. The Postal Service could block or destroy shipments for which the information is not provided."

The package will provide funds for the research and development of new, non-addictive painkillers and allow the U.S. Food and Drug Administration to require certain opioids be dispensed in packaging that limits their abuse potential.

Critics of the bill say it's not enough to fully combat the opioid crisis and what is needed is an infusion of money similar to the billions of dollars that has been spent on HIV/AIDS.

Inside Health Policy reports that a House-backed measure that sought to loosen privacy restrictions on medical records containing information about substance abuse was dropped from the final package.

Also missing, Goodnough writes, is a provision that the pharmaceutical industry pushed hard for that "would have softened a requirement for drug manufacturers to start providing larger discounts next year to Medicare beneficiaries whose spending on prescription drugs falls in a coverage gap called the “doughnut hole."

Bevin gets bill to ban most common type of 2nd-trimester abortion

By Melissa Patrick
Kentucky Health News

FRANKFORT, Ky. -- A  House bill to ban the most common kind of second-trimester abortion has finally passed and is headed to Gov. Matt Bevin's desk for his signature. But that may not be the end of it.

Rep. Addia Wuchner

House Bill 454, sponsored by Rep. Addia Wuchner, R-Florence, would prohibit an abortion procedure known as dilation and evacuation, or D&E, after roughly 11 weeks of pregnancy except in medical emergencies. Reuters reports that 16 percent of all abortions performed in the state use D&E.

The procedure involves dilating the cervix and removing the fetus using suction and surgical tools. If the bill becomes law, abortion providers found in violation of it would be guilty of a felony that carries a prison sentence. The women undergoing the procedure would not be prosecuted.

"This law here in the commonwealth is about the humane treatment of an unborn child, to protect an unborn child from dismemberment," Wuchner said while presenting the bill to the House.

Critics of the bill said it is unconstitutional and will likely face legal challenges.

A federal court struck down a ban on the procedure in Texas, and similar bans have been temporarily blocked in Alabama, Arkansas, Kansas, Louisiana, and Oklahoma while litigation proceeds. Mississippi and West Virginia have similar bans that haven't been challenged in court, because the bans aren't expected to have an impact on abortion services, according to the American Civil Liberties Union of Kentucky.

The bill passed the House March 12 by 71-11 vote and the Senate March 22 by 31-5. A Senate change was approved in the House March 27 by 75-13 to a room full of applause. The Senate change made the definition of "unborn child" to mean from fertilization until live birth.

Opponents of the bill also say that without legal access to D&E procedures, Kentucky women will be limited to undergoing more expensive abortions that would require a hospital stay, and that by law, no publicly owned healthcare facility can perform abortions, unless it's to save the life of the pregnant woman. In addition, they say that this is part of a larger anti-abortion strategy to ban the procedure altogether.

In 2016, the state's "informed consent" law was amended to require women seeking an abortion to have a face-to-face or live-chat consultation before the procedure.

 In 2017, when Republicans took full control of the General Assembly, it passed two abortion bills that were signed into law by Republican Gov. Matt Bevin, who was elected in 2015. One banned abortions after 20 weeks of pregnancy, unless the mother's life is in danger. The other required women to get an ultrasound before an abortion that included an audible heartbeat, and required the doctor to show and describe the image of the fetus to the patient before performing the abortion. This law was struck down in court, but the state has appealed.

The only remaining abortion clinic in Kentucky, EMW Women's Surgical Center in Louisville, is in a legal battle with the state over licensing issues.

Federal judge strikes down new abortion law that required narrated ultrasound; Bevin administration says it will appeal

A federal judge has struck down a new Kentucky law that required a physician to perform an ultrasound and display and describe the image of the fetus to the patient before providing an abortion, Darcy Costello and Deborah Yetter report for The Courier-Journal.

In a one-page opinion, District Judge David Hale ruled Sept. 27 that House Bill 2, which also required the physician to play an audible heartbeat of the fetus to the patient, violates a physician's First Amendment rights. Supporters of the law, which was enacted in January, say it was meant to better inform women seeking an abortion.

Hale wrote in his 30-page opinion: "HB 2 is intended to dissuade women from choosing abortion by forcing ultrasound images, detailed descriptions of the fetus and the sounds of the fetal heartbeat on them, against their will, at a time when they are most vulnerable."

The Courier-Journal reports that a lawyer for EMW Woman's Surgical Center in Louisville, the state's only abortion clinic, called the ruling a victory for patients, but supporters have promised an appeal to the U.S. Court of Appeals for the 6th Circuit.

"We are disappointed in the court's ruling and will appeal immediately to the 6th Circuit," Amanda Stamper, a spokeswoman for Gov. Matt Bevin, told the newspaper. "We are confident the constitutionality of HB 2 will be upheld."

But Andrew Beck, a lawyer with the American Civil Liberties Union's Reproductive Freedom Project, told the Courier-Journal that he expects Hale's permanent injunction to withstand an appeal. "It's an extremely solid ruling," he said.

Hale said the law is "designed to convey the state's ideological, anti-abortion message" and goes "well beyond" the basic information that a physician should give a patient. He added that the law "appears to inflict psychological harm on abortion patients."

HB 2 permits a woman to look away from the image and cover her ears, but physicians who failed to attempt to show and describe the fetus to the patient could face fines of up to $250,000 and action against their medical license. State law already requires counseling 24 hours in advance of an abortion.

The ultrasound law is one of two abortion bills the legislature passed during its first week this year after Republicans took control of both chambers. The second measure, Senate Bill 5, bans abortions at or after the 20th week of pregnancy. An attorney with the ACLU told The Courier-Journal that they don't plan to challenge that law, but will continue to monitor it.

Meanwhile, the state's only abortion clinic awaits a judges ruling to determine if it can remain open.

The Bevin administration revoked its license in March, claiming it lacked appropriate agreements with a hospital and ambulance service in the event of a patient emergency. After a three-day trial earlier this month, it was granted a temporary restraining order so it can remain open until the judge rules on the case, which is expected later this year.

Legislature passes bills to name caregivers, help smokers quit; could still pass dense-breast notice and student-concussion bills

By Melissa Patrick
Kentucky Health News

FRANKFORT, Ky. – Kentucky lawmakers have passed bills this year to make sure someone knows how to care for you when you leave a hospital, expand the role of pharmacists, increase access to smoking cessation, and offer some hope to terminally ill patients, among other health-related measures.

The bills now await Gov. Matt Bevin's signature or veto. Legislators will reconvene March 29 and 30 to reconsider any bills he vetoes; they could also pass additional legislation, but it would be subject to a veto without the opportunity for a override. Now that both houses of the General Assembly are controlled by the governor's party, such eleventh-hour legislation may be more likely.

Health bills that have passed

The "Kentucky Family Caregivers Act," Senate Bill 129, would require hospitals to record the name of a lay caregiver when a patient is admitted, notify that person when the patient is moved or discharged, and instruct the caregiver on the medical tasks he or she will need to perform when the patient goes home. The patient can decline this request. The bill, sponsored by Sen. Paul Hornback, R-Shelbyville. passed unanimously through both chambers and awaits the Governor's signature.

AARP, which supports this legislation, estimates that there are 650,000 family caregivers in Kentucky who save the state around $7 billion a year in health-care costs. AARP said in a statement that the bill will save even more money by improving post-discharge outcomes, reducing hospital readmissions and better allowing Kentuckians to recover at home, where they want to be.

The "Right to Try" bill, SB 21, also awaits the governor's signature. Sponsored by Sen. C.B. Embry Jr., R-Morgantown, it would make it easier for terminally ill patients to use experimental treatments. Terminal patients would be able to try drugs that have successfully completed the first phase of clinical trials but have not yet been approved by the U.S. Food and Drug Administration, with appropriate documentation from their health-care provider and approval of the drug company. The bill passed unanimously through the Senate and cleared the House 87-7.

"Right to Try" legislation has passed in 33 states and has been introduced in Congress, and has the support of Vice President Pence, Bloomberg News reports.

Kentucky lawmakers passed two bills that would expand the role of pharmacists.

SB 101, sponsored by Sen. Julie Raque Adams, R-Louisville, would allow pharmacists to administer all age-appropriate immunizations to minors aged 9 to 17. Current law allows pharmacists to administer flu vaccines starting at age 9, but for all other vaccines, pharmacists can only administer to minors starting at age 14. This bill unanimously passed both chambers and awaits the governor's signature.

SB 205, sponsored by Sen. Stephen Meredith, R-Leitchfield, would allow pharmacists to dispense a 90-day-supply of a non-controlled maintenance drug, such as those for blood pressure or high cholesterol, unless the prescription provides to the contrary. The bill passed unanimously in both Chambers and awaits the governor's signature.

Only one bill aimed at decreasing the state's high smoking rate has passed this session. SB 89, sponsored by Adams, would require all Kentucky health plans, including Medicaid, to provide barrier-free access to any smoking-cessation treatments approved by the U.S. Preventive Service Task Force. Some insurance companies have barriers to treatment, such as co-payments and prior authorizations. Bevin signed the bill March 21.

Health bills unlikely to pass

SB 78, which would have made Kentucky's schools 100 percent tobacco free, passed the Senate but couldn't get enough support among Republicans who control the House to be brought up in committee.

Two other bills aimed at protecting the health of children made no headway: House Bill 252, which would require an automated external defibrillator in every school; and HB 122, which would require children up to the age of 12 to wear a bicycle helmet.

Three bills that would increase the state's access to health-care providers also did not pass this session. SB 158 would repeal the requirement for nurse practitioners to work under a collaborative agreement with a physician to prescribe narcotics and some other controlled substances, and for the first four years of prescribing other drugs. HB 19 and SB 55 would have permitted physician assistants to prescribe and dispense controlled substance. The bills may have been hamstrung by the state's epidemic of opioid abuse.

Another bill that is dead this session is Senate Bill 108, dubbed the "Palliative Care" bill. This bill passed the Senate unanimously, but Rep. Addia Wuchner, chair of the House Health and Family Services Committee, says it needs more work. The bill's aim is to use training and education to increase access to palliative care, which is aimed at providing the best quality of life possible for patients with chronic or terminal diseases.

Health bills that could pass

One health bill likely to pass in the final two days is HB 78, which would require providers of standard mammograms to inform patients if they have "dense breast tissue" when appropriate, because such tissue can hide cancers. The notice would allow patients who have dense tissue the opportunity to determine with their provider if they need further screening.

Almost 40 percent of women have dense breast tissue, and some men do. They are twice as likely to develop breast cancer, Rep. Jim Duplessis, R-Elizabethtown, the bill's sponsor, said at the bill's hearings. The Dense Breast-info website says 27 states require some level of breast density notification after a mammogram. The bill passed unanimously through the House, passed a Senate committee and is before the full Senate.

Another bill that could pass would prohibit a coach from playing a student-athlete who has been diagnosed with or is suspected of having a concussion without written clearance from a physician. House Bill 241, sponsored by Rep. John Sims, D-Flemingsburg, passed unanimously in the House, passed a Senate committee and is before the full Senate.

This story was updated March 22.

Republicans want to block-grant Medicaid but can't agree on how

Most Republican lawmakers and President Donald Trump support a plan to turn Medicaid into a block-grant program, which would limit spending and give each state a set amount of money each year to care for its poor and disabled citizens largely in the way it sees fit, but they remain divided on just how to do it, Burgess Everett, Rachael Bade and Rachana Pradhan report for Politico.

One of the Republicans' challenges is that Trump has said he wants to keep covered the roughly 11 million people who gained coverage under the Patient Protection and Affordable Care Act's Medicaid expansion program, including 440,000 in Kentucky, while also supporting block grants.

These two ideas are "fundamentally at odds with each other because block grants are widely viewed as likely to result in sweeping cuts in government-subsidized health insurance for the poor," which is making it hard for lawmakers to "coalesce around a plan," Politico reports. In total, Medicaid covers roughly 70 million Americans.

Sen. Steve Daines, R-Mont., whose state expanded Medicaid under Obamacare, told Politico that he wants to make sure his constituents keep their coverage: “I’m not seeing any proposal or discussion around a replacement that doesn’t address the fact that we’ve got to take care of these folks that have expanded Medicaid."

But House Budget Vice Chairman Todd Rokita, R-Ind., a strong advocate of block grants, said: “Medicaid is among the top three drivers of our debt. It’s unfair for the citizens of tomorrow to bear the burden through our debt load for the health care of today’s poor, and it’s especially not fair for them to pay for [able-bodied adults] who otherwise should be making their own way.”

But Republicans remain divided on whether to support fixed-rate block grants, which would cause "steep cuts to the program" or one that provides funding based on the number of people who qualify for it, rather than a fixed cap, often called "per beneficiary" or "per capita" payments, Politico reports.

Sen. Bill Cassidy, R-La., who supports the per-beneficiary plan, told Politico that straight block grants don't account for demographic or population changes or variances in health-care costs from state to state.

Rodika, a strong conservative, supports the fixed grants because "limiting a resource, like block grants do, always increases innovation and efficiency," adding that the per-beneficiary approach would be expensive and keep the federal government too involved the program.

House Speaker Paul Ryan's “Better Way” agenda last year proposed that states be allowed to choose which option they prefer.

Critics, especially Democrats, say block grants would put coverage for millions of low-income people at risk. "They’re unlikely to support either plan," Politico writes.

“I can’t conceive of any way in which a block grant would not put vulnerable people at risk,” Sen. Ron Wyden, D-Ore., told Politico. Republicans want, he said, “an ideological trophy — the repeal of [Obamacare] — and then maybe down the road we’ll talk about poor people.”

Despite their differences in opinion, Republicans are working to find a way to include Medicaid reforms into the fast-track Obamacare repeal bill, which is expected to pass both chambers in March or April. If they can figure this out, they won't need Democratic help, but if they can't, they will need at least eight Democrats to get the 60 needed votes in the Senate, which is "likely to prove impossible," Politico reports.

Kindred agrees to pay $125 million for Medicare fraud claims against subsidiaries it bought after most wrongdoing occurred

Louisville-based Kindred Healthcare Inc. has agreed to pay $125 million to settle federal allegations that it knowingly submitted false claims to Medicare for rehabilitation therapy, according to a U.S. Department of Justice news release.

The lawsuit, brought by two whistleblowers, focused on contract providers RehabCare Inc. and RehabCare Group East Inc., which Kindred bought in 2011, after most of the alleged wrongdoing occurred. RehabCare is the largest provider of therapy in the nation, according to the release.

The Justice Department announcement alleged that RehabCare had set "unrealistic financial goals" and scheduled therapies "to achieve the highest reimbursement level," regardless of the needs of the patients, providing services that were not "reasonable, necessary and skilled, or that never occurred."

"This False Claim Act settlement addresses allegations that RehabCare and its nursing facility customers engaged in a systematic and broad-ranging scheme to increase profits by delivering, or purporting to deliver, therapy in a manner that was focused on increasing Medicare reimbursement rather than on the clinical needs of patients,” U.S. Attorney Carmen M. Ortiz of Massachusetts said in the release.

Allegations against RehabCare include: placing patients in therapy at the highest reimbursement level, regardless of the patients actual therapy need; ramping up the amount of reported therapy during the Medicare assessment period; scheduling therapies even after the patient had been discharged by their therapist; arbitrarily shifting the amount of time to other therapy disciplines, like physical or speech therapy, to achieve maximum reimbursement levels, regardless of patient need; providing "significantly higher amounts of therapy" at the end of therapy to achieve the highest level of therapy reimbursement; inflating initial reimbursement levels by reporting evaluation time as therapy time; rounding up actual therapy minutes provided; and billing for services for patients while they slept or couldn't benefit from them.

RehabCare denied any illegal activity, "but in order to provide clarity for contract customers, shareholders, and government oversight entities," and to "avoid the cost and distraction of protracted litigation" has agreed to the settlement without any admission of wrongdoing, according to the Kindred news release.

Since January 2009, the Justice Department has recovered more than $27.1 billion through False Claims Act cases, with more than $17.1 billion from cases involving fraud against federal health-care programs, according to the department.

Reform law's backers say it boosts economy by freeing 'job lock;' foes cite estimate that it will make some drop out of job market

As the Patient Protection and Affordable Care Act's second enrollment period gets underway, supporters of the law say it boosts the economy by creating an affordable, accessible insurance market that's not dependent on employer-based insurance.

Travis Kalanick, co-founder of Uber, said the law has been "huge" for his personal-transportation business. Uber's drivers are independent contractors, so the company does not provide them with health insurance. But because the ACA creates a functioning individual market for health insurance, making it easier and more affordable for Uber drivers and others to buy coverage on their own, Americans don't have to stay in a job just to keep their health insurance.

"The democratization of those types of benefits allow people to have more flexible ways to make a living,” Kalanick said during dinner for reporters, according to Buzzfeed. “They don’t have to be working for The Man.”

This is why Uber loves Obamacare, reports Jason Millman of The Washington Post. For a company like Uber, it's about liberalizing the workforce so that people are able to take jobs they do like that don't provide health care, he writes.

Numerous sources cite the ability of individuals to obtain affordable coverage outside of the workplace as a boon to the labor market. A Congressional Budget Office analysis earlier this year said giving families more options for obtaining affordable health insurance outside the workplace, the PPACA removes a barrier to job mobility and boosts the economy.

Before the PPACA, many Americans’ only source of secure health-insurance coverage was through their jobs because without work-based plans, people often found coverage to be too expensive or impossible to obtain due to pre-existing conditions. This created a health-insurance obstacle to labor mobility, which is sometimes called "job lock", writes the Jason Furman in an online post from the White House Council of Economic Advisers.

Job lock can prevent individuals who want to look for a better job, change careers or start a new business from doing so for fear of not having health coverage, the CBO said. Now, because of both the PPACA’s patient protection measures and ban on discrimination against people with pre-existing conditions, Americans have reliable access to health insurance without having to count on employers to provide it, says the report. CBO also said many Americans will be able to start small businesses or take new positions where they can be more productive because they don't have to worry about health insurance.

Opponents of the law argue that it shrinks the labor market. For example, in a Forbes article, Avik Roy writes that the law hampers job growth by imposing one of the largest tax hikes in U.S. history, increasing the cost of employing workers and establishing exchange subsidies that encourage workers to drop out of the job market. They cite a CBO estimated that by 2024, 2.5 million full-time-equivalent workers will drop out of the job market. Jay Carney, then White House press secretary, celebrated the findings, arguing that they mean that Americans would no longer be “trapped in a job,” Roy writes.