KET will air three hours of programs on youth mental health in November; first one airs Monday, Nov. 5 at 9 p.m. ET

Kentucky Educational Television will broadcst a six-part series called "You Are Not Alone," aimed at raising awareness of the issues regarding the mental health of Kentucky youth.

Topics will include depression, anxiety, stigma, suicide prevention, trauma, toxic stress, parental concerns and challenges, the role of schools, youth advocacy and promising strategies.

The six 30-minute programs, hosted by Renee Shaw, will air back-to-back on three consecutive Mondays in November. The first two, "Youth Speak Out" and "Help for Families and Caregivers" will air Nov. 5; "Whole Child, Whole School" and "Depression and Anxiety" will air Nov. 12; and "Trauma and Toxic Stress" and "Suicide Prevention/ Teaching Hope" will air Nov. 19.  All will begin at 9 p.m. ET.

Reporter writes about beating breast cancer, but perhaps most importantly, about first finding it: 'scheduling the mammogram'

One day each year, many newspapers go pink -- with pink ink or pink paper -- to increase awareness of breast cancer and support research to find a cure. This year, the Lexington Herald-Leader led its front page with a very personal a gripping story by staff writer Cheryl Truman about her breast cancer diagnosis, surgery and chemotherapy, and her struggle to get her life back and deal with troubling parts of the health-care system. The story is 1,928 words, and the most important may be at the end:

"Sometimes I will stop a moment and touch a flower, look for an extra few seconds at the farm view from my deck, brag about how the kids turned out. I am here to do that, and it has made all the difference," Truman writes. "Part of it is medicine, part luck. The first part was scheduling the mammogram."

Study predicts number of Kentuckians who drop off Medicaid will double if work and 'community engagement' rules are approved

By Melissa Patrick
Kentucky Health News

The federal-state Medicaid program provides health coverage to about 1.4 million Kentuckians, or about one in three. The exact number fluctuates, because Medicaid and other social programs have a substantial "churn," people coming onto the program as others come off.

WKYT-TV image

If work requirements are approved for Kentucky Medicaid, the number of people "churning off" of the program in the state would double over a two-year period, going from an estimated 108,000 adults to 216,000, estimates The Commonwealth Fund, a New York-based foundation that supports independent research on health policy reform.

The report says it "should be of concern to policymakers" because research shows that people with gaps in health insurance coverage "report problems getting health care or paying medical bills at rates nearly as high" as those who go without insurance at all.

To predict how work requirements would affect the insurance coverage of Medicaid enrollees, the researchers first analyzed data from federal polling to determine coverage patterns among non-disabled -- or "able-bodied"-- adults on Medicaid, and then applied those findings to a similar group of Kentucky adults.

In Kentucky, most people in this category are those who gained health insurance under the  expansion of Medicaid to those who earn up to 138 percent of the federal poverty level (about $16,000 for a single person). The expansion, under the Patient Protection and Affordable Care Act, added about 500,000 Kentuckians to the Medicaid rolls, most of whom work.

To determine the potential "churn," the study looked at national Medicaid enrollment in 2014 and 2015, when 9 million Americans were on the program and 3 million people churned off it. The researchers found that 37 percent of them remained uninsured, 28 percent regained Medicaid coverage and 35 percent got another source of coverage.

What about Kentucky?

The researchers then applied those findings to Kentucky, where Gov. Matt Bevin wants to require 80 hours a month of "community engagement" -- work, schooling or drug treatment -- for people on Medicaid who are not disabled, medically frail or primary caregivers. A federal judge in Washington, D.C., vacated the plan and the Centers for Medicare and Medicaid Services is still reviewing the issue.

District Judge James Boasberg said federal officials had not sufficiently considered public comments about the state's new plan, which were overwhelmingly against it, nor had they adequately considered the state's estimate that in five years its Medicaid rolls would have 95,000 fewer people with the plan than without it -- largely for non-compliance with its engagement or reporting requirements.

Based on federal Medicaid data for Kentucky, which showed about 325,000 non-disabled adults under 65 in the program in 2016-17, the researchers estimated that over two years, about 108,000 Kentucky enrollees would churn off of Medicaid if the program remained unchanged.

With the work requirements, the number leaving the program over two years would double, to 216,000, the researchers estimated.

"Depending on people's ability to regain Medicaid or gain private coverage with work requirements in place, the number of adults who would remain uninsured at the end of the two-year period ranges from 77,500 to 117,400," the report says.

The researchers add that they probably underestimated the number of people who will become uninsured as a result of work requirements, because the study only examined adults who had coverage at the beginning of the study period and didn't consider those who might have become eligible for Medicaid during those two years -- those who might not enroll under the proposed plan because of the administrative barrier created by the work requirement.

Over 8,000 kicked off Medicaid in Arkansas; advisory panel seeks a pause

Arkansas introduced its work and community-engagement requirements in June and has already kicked more than 8,000 people off of its Medicaid program for noncompliance -- with another 4,841 set to be kicked off in November if they don't comply with the new rules before then, according to a state report. Beneficiaries in Arkansas are kicked off if they fail to report sufficient work hours for three months in a given calendar year. They will be allowed to reapply in January.

A pending lawsuit seeks to invalidate the Arkansas program, and because of its similarities to Kentucky's case, Boasberg is handling the case.

Members of the Medicaid and CHIP Payment and Access Commission plan to ask the Trump administration to hold off on approving Medicaid work requirements, Victoria Pelham reports for Health Care on Bloomberg Law, a subscription-only newsletter.

Fourteen states have either gained approval for or have submitted applications to require able-bodied adults to have to work or participate in approved activities, like looking for a job or job training, in exchange for their Medicaid coverage, says the report,  concluding: "Adding new enrollment barriers such as work requirements will accelerate churn in the states that pursue them and leave hundreds of thousands without access to health care."

What do other studies say?

Other studies indicate work requirements undermine Medicaid enrollment.

A Center on Budget and Policy Priorities analysis estimates that between 45,000 and 103,000 Kentucky Medicaid enrollees could lose coverage because they won't meet new eligibility or paperwork requirements if the state is allowed to implement its new work requirements. This report adds that there is no evidence that beneficiaries who have lost their coverage will move to jobs with affordable private coverage and they will likely become uninsured.

The Bevin administration says a major goal of its plan, called Kentucky HEALTH for "Helping to Engage and Achieve Long Term Health." is to move Medicaid beneficiaries to private insurance. An Urban Institute analysis found that Medicaid beneficiaries tend to work in part-time, low-paying jobs and are unlikely to gain employer-sponsored insurance, since only 13.3 percent of part-time private-sector employees in Kentucky were eligible for such insurance.

Speaking only to these two analyses, Cabinet for Health and Family Services spokesman Doug Hogan said in an e-mail:

"Gaining access to employer-sponsored insurance (ESI) is just one potential path. It was never expected that a large percentage of the Kentucky HEALTH population would immediately see access to ESI. Some would see eligibility for subsidies on the ACA exchanges after graduating Medicaid eligibility. Some would have to upskill or increase educational attainment before finding employment that could move them up the income scale. . . . There are numerous studies that show that engagement and employment are linked to health, and that community engagement requirements are effective in driving participation."

Only syringe exchange in Lincoln Trail health district is a point of pride for Nelson County, Bardstown newspaper says in editorial

This editorial appeared in The Kentucky Standard, Bardstown, on Oct. 25.

Nelson County should take pride in its syringe exchange.

That might sound strange, at first. After all, a community sets up an exchange when it has a problem with substance abuse.

But the truth of the matter is that Kentucky has a substance abuse problem throughout the state. It can be hard for an idyllic historical town such as Bardstown or as bucolic a county as Nelson to admit that such a modern problem as intravenous drug abuse is just under the surface.

But that is just what Nelson County did when it authorized the needle exchange with the Lincoln Trail Health Department, the only one in the eight-county region.

Photo illustration by The Kentucky Enquirer

Staff from the health department and the exchange visited Nelson County Fiscal Court recently to provide an update following its first annual report.

One number on that report had caught some attention — the return rate of syringes, which was only 36 percent. That means that for every almost three syringes given out, only one was exchanged. At first blush, that does not come off as good.

But, part of that reason is simple math, as Sara Jo Best, the department’s director, explained to the magistrates.

Only a little more than half of the 96 people who sought out services last year ever came back for a second visit. And the vast majority of substance abusers don’t show up the first time with used needles.

The simple fact is that collecting used syringes is not the primary mission of the exchange. Syringe exchanges are about controlling communicable diseases among a population that is highly susceptible to them. And protecting intravenous substance abusers against hepatitis, HIV and other diseases also shields the wider population, because these diseases are not only transmitted through needles. Part of preventing the spread is taking dirty needles off the streets and out of homes, but that is just one part, and arguably not the most important.

One of the biggest advantages of having a syringe exchange is the ability of public health workers to reach a population that can be hard to find.

And these substance abusers are some of the ones where there lies the most potential to make a difference.

“People who come to a syringe exchange program are fundamentally different than those who are not,” Kentucky Commissioner for Public Health Dr. Jeffrey Howard told The Standard recently. “If you are a substance abuser and you say, ‘I’m going to go to a syringe exchange program and get clean syringes,’ then you have acknowledged there’s something negative to what you’re doing and you’re going to take an action about that negative aspect. So in the psychology of that person, they are further along the addiction recovery pathway than someone who is not. We really need to take advantage of that.”

That’s why Howard said he wants to rebrand “syringe exchanges” into “harm reduction” centers, where substance abusers are linked to services such as testing and health screening and addiction recovery programs.

Best told Fiscal Court that is the approach the local exchange is looking to take. She acknowledged they had identified needed areas for improvement, and had already made some changes. One was finding a disease screening that returned faster results. In its first year, 34 percent of clients were tested for Hep C, but staff hope the faster results will improve that rate.

The number of participants could also improve, especially on the returns. Part of that is building trust with the participants, and some of that will involve time. It also means outreach, as Best said, so that those who need the services know where to find them.

Syringe exchanges in this state are new. While exchanges have been around in more densely populated areas for many years, operating one in a smaller and more rural area brings a host of new issues as well as insights.

But too often, fear of failure or the unknown stops organizations or agencies from trying something new. Those fears could be partly to blame for surrounding counties’ refusal to start their own. But if they think turning a blind eye will make the problem go away, they are wrong.

At least here in Nelson, we have acknowledged the problem, and after a year we understand it better. That goes a long way toward dealing with it.

Local outbreak of hepatitis A declared in Madison County, calling for vaccinations; heavy demand for vaccine in Whitley County

Madison County health officials have declared a local outbreak of hepatitis A and called on all local residents to get vaccinated for the liver disease that lives on poor hygiene.

"There are now 24 hepatitis A cases in Madison County related to the statewide outbreak that produced more than 2,050 across Kentucky," reports Mike Stunson of the Lexington Herald-Leader, citing the county health department. "It reported 13 cases on Oct. 6."

The department recommended hepatitis A vaccinations for all residents.

In Whitley County, where 99 cases have been reported, "Pharmacies are struggling to keep up with the demand for vaccines," reports Phil Pendleton of Lexington's WKYT and Hazard's WYMT.

"Rick Loudermelt at Whitley Pharmacy in Williamsburg says they have given out numerous vaccines since May of this year," Pendleton reports. "He says it's been hard to keep up with the demand, administering between 15 and 20 a week."

Madison County Public Health Director Nancy Crewe said vaccinations “should have a mitigating effect on the severity of the outbreak. We certainly don’t think there is any need for panic, but it is important that we get the word out to our citizens and encourage them to get the vaccine.”

The state Department for Public Health says more than 1,100 people have been hospitalized, and 14 died, in the statewide outbreak since November 2017.

Hepatitis A is usually spread when someone eats or drinks something contaminated by small amounts of stool from an infected person, according to the health department.

Symptoms include fever, fatigue, loss of appetite, nausea, abdominal discomfort, dark urine and yellowing of the skin and eyes. People can become ill 15 to 50 days after being exposed to the virus.

"Aside from the vaccination, good hand-washing is also recommended to help control the spread of hepatitis A," Stunson notes.

Feds form strike force to fight opioid abuse in Appalachia

The U.S. Department of Justice is forming a strike force to fight opioid abuse in Appalachia.

"Assistant Attorney General Brian A. Benczkowski says the Appalachian Regional Prescription Opioid Strike Force will investigate health-care fraud schemes and prosecute medical professionals and others involved in the illegal distribution of opioids," The Associated Press reports.

The department said the strike force will include extra prosecutors, the FBI, the Drug Enforcement Administration and the Department of Health and Human Services Office of the Inspector General.

Benczkowski said suffering caused by opioid abuse is "particularly staggering" in Appalachia. He says the problem is "more reprehensible when unscrupulous physicians and pharmacies" contribute to the epidemic by illegally supplying prescription painkillers.

Seniors can save lots of money by shopping around for Medicare drug plans, but few do; here are tips

Chart shows average premiums for most popular stand-alone Medicare prescription drug plans.

Seniors could save millions of dollars by shopping around for Medicare drug plans, but few do, Trudy Lieberman writes for Rural Health News Service: "With drug costs climbing for seniors, careful shopping is important this open-enrollment season," which for Medicare runs through Dec. 7.

“It’s not easy to compare options, but differences do matter,” Tricia Neuman, senior vice president of the Kaiser Family Foundation, told Lieberman.

And it can matter to a lot more people than it did before. "More than one million beneficiaries with drug benefits had spending above the threshold in 2015, more than twice the number in 2007," Lieberman reports.

Still, few "shop and compare Part D plans, even though this year the average Medicare beneficiary has a choice of 27 stand-alone Part D plans," for people in traditional Medicare, and 24 Medicare Advantage plans that include the drug benefit. Medicare.gov has a drug-plan finder to compare plans, but "Many people remain skeptical they can get a better deal, and may lack computer skills to find the best choice." Also, a third of Medicare beneficiaries have cognitive impairments, Lieberman notes.

Lieberman offers tips for Medicare drug shopping:

• Check for your regular drug(s) in the insurance plan’s tiers, preferred or non-preferred. A drug might be in one plan's non-preferred tier but in another's preferred tier, making it cheaper. Some drugs in the non-preferred tiers may require you to pay 50 percent of the cost. Specialty drugs have their own tier, usually with 33 percent consumer payment for non-preferred drugs.
• "Generic drugs might not be cheaper," Lieberman writes. "A generic in the non-preferred tier might be more expensive than a brand-name drug in a plan’s preferred tier."
• Does the plan requires “step therapy,” which means you must first try lower-priced drugs? Is preauthorization for services required? A Kaiser found that 80 percent of beneficiaries were in plans that required preauthorization for any service -- including Part B drugs administered in a doctor’s office. "Many consumers find preauthorization a real hassle," Lieberman notes.
• Talk with your health-care provider about cheaper alternatives. Maybe there is one in a plan’s preferred category. Prescribers "are often not knowledgeable about the ins and outs of drug plans, and may not have a patient’s financial wherewithal in mind when they write the prescription," Lieberman writes.

Average premiums on most popular Obamacare plan in U.S. will drop 1.5% in 2019; go up 9% in Ky.; state still lower than average

Chart from Insider Louisville

The average premium for the most popular health insurance policy on the federal exchange, called the "silver plan," will drop by 1.5 percent next year -- but not in Kentucky, where the rate for that same plan will increase by 9 percent.

A Centers for Medicare and Medicaid Services news release notes that 2019 will be the first year the national average has dropped since full implementation of the Patient Protection and Affordable Care Act in 2014. This year the average premium for these benchmark "Obamacare" plans increased by an average of 37 percent, and by 25 percent the prior year.

Nationally, CMS says a 27-year-old, single non-smoker who gets insurance through the exchange, HealthCare.gov, will pay an average annual premium of $4,872, down from $4,944. In Kentucky, that will rise to $4,524, from $4,152.

Healthcare.gov customers in 17 of the 39 states will see declines, three will see no change and customers in Kentucky and 19 other states will see an increase in their premiums in 2019, Boris Ladwig reports for Insider Louisville.  

Ladwig adds that despite the 9 percent increase in Kentucky, the state's rates for 2019 remain in the lowest third among the 39 state in the exchange. In Kentucky, about 90,000 people signed up for an Obamacare plan during the 2018 open enrollment. Nationally, that number was around 12 million.

CMS has said the reduction is a result of the Trump administration's efforts to stabilize the individual market, but the Kaiser Family Foundation, and other health experts, say it is a result of insurers overcompensating their rates in 2018 after the administration lowered the subsidies it paid to insurers and also because insurance companies that offer Obamacare plans are making a profit.

In Kentucky, Anthem Health Plans of Kentucky and CareSource will offer federally subsidized plans on Healthcare.gov, with rate increases of 4.3 percent and 19.4 percent, respectively. Anthem will expand its coverage area into 34 counties it once served, to cover a total of 93. CareSource will cover 61 of the state's 120 counties.

The Kentucky market president for CareSource, Michael Tayler, told Kentucky Health News in an e-mail that its premium increases for 2019 result from a number of factors.

"The elimination of the individual mandate that relieved the consumer tax penalty, and inflation related to medical and prescription drug costs, both impacted our rate decisions," he said. "It’s these factors and other federal policy changes related to short-term limited duration and association plans that will most likely cause consumers with the greatest health care needs to enroll. These changes may create a gap in marketplace participation and ultimately a greater risk for insurers."

The Kentucky Department of Insurance and Anthem did not respond to requests for comment.

Open enrollment on HealthCare.gov begins Nov. 1 and will run through Dec. 15.

Analysts tell health advocates that Medicaid budget 'shortfall' described by state officials is premature

By Melissa Patrick
Kentucky Health News

The warning from the administration of Republican Gov. Matt Bevin that some Medicaid benefits may need to be cut because of a budget shortfall over the next two fiscal years has caused unnecessary alarm, a research and policy analyst for the Kentucky Center for Economic Policy, said at the Kentucky Voices for Health annual meeting in Lexington Oct. 19.

Analysts Jason Dunn and Dustin Pugel
gave an update on health policy at the
Kentucky Voices for Health meeting.

Dustin Pugel referred to a presentation the Cabinet for Health and Family Services made in August to the legislature's Budget Review Subcommittee on Human Resources, predicting that over the next two fiscal years the state will be $300 million short in what it needs to pay for Medicaid.

"There's some problems with their math," Pugel said.

He said the cabinet based its estimate on its initial forecast of expenses, though there is almost always a gap between what an agency requests and what the legislature puts in the budget.

"To call that a shortfall is strange," Pugel said. "And if, in fact, you add up all of the agency requests in the entire budget versus what was enacted, then we would say that we have a $2 billion shortfall in the general fund, which of course we don't." He said the projected "shortfall" would be only 1 percent of the state's total budget.

Medicaid is a joint state and federal health insurance program that spends about $11.5 billion a year to cover 1.4 million Kentuckians, nearly one in three. Before its expansion under the Patient Protection and Affordable Care Act in 2014, by Democratic Gov. Steve Beshear, the program was mainly limited to very poor pregnant women and children, disabled people and low-income elderly in nursing homes.

Asked in September to respond to the KCEP report on this topic, cabinet spokesman Doug Hogan said cabinet officials explained to the legislators that their overall concern is about a shortfall in the state's General Fund because the state must have money in the fund to get federal matching money.

"The state General Fund shortfall is 6.61 percent in FY19 and 5.61 percent in FY20," Hogan said in an e-mail. "This is significantly more than 1 percent, and not easy to adapt to, since Medicaid spending is primarily driven by two things: (1) the number of eligibles and (2) benefits costs, much of which are mandatorily required under federal law."

Pugel said the cabinet's own data shows that benefit costs and Medicaid enrollment are declining, which "should indicate that Medicaid expenditures will come in under the initial expectation."

Pugel told the roomful of health advocates that the cabinet's proposed solution to this "shortfall" is to eliminate dental, vision and pharmacy benefits to those on Medicaid, or even to end the expansion of the program to those who earn up to 138 percent of the federal poverty level. The expansion added about 500,000 people to the Medicaid rolls.

"Even if it were true, we have a lot of time," Pugel said. "We've got a fiscal year and a half to be able to figure this out and there's really not a lot of cause for alarm -- and alarm in this case would be threatening to remove very important benefits."

The center's report adds that the cabinet failed to explain the context for the projected shortfall and ignored additional resources that were already appropriated to deal with some of the costs.

For example, the report says the cabinet's shortfall spreadsheet includes higher fees for dispensing drugs and increases in the Supports for Community Living and Traumatic Brain Injury programs without showing that $91 million was appropriated to offset those costs.

Hogan said the cabinet did not "ignore" those resources. He wrote, "This demonstrates that KCEP does not understand or chooses to ignore CHFS testimony about how the shortfall was projected, which was to take the Consensus Forecast Group projection, add additional costs not anticipated by CFG that occurred after CFG made projection, and then look at the difference in the enacted budget amount."

Asked about this, Pugel held to his center's claim. "To add those as additional costs without any indication that they are also paid for is erroneous," Pugel said in an e-mail. He added that the financial director tried to make this point clear at one point in the meeting, "but it was a short explanation and the point didn't come across to the lawmakers."

Hogan wrote, "KCEP is an agenda driven left leaning organization that inaccurately interprets data to support its narrative. KCEP lives in a fictional land where money and resources are unlimited and solutions typically involve simply throwing more money at whatever issue they are looking at that particular day, while ignoring that the money must come from somewhere else."

UK gets $15 million grant to treat 900 drug users with hepatitis C in Hazard area to examine concept of 'treatment as prevention'

By Melissa Patrick
Kentucky Health News

The University of Kentucky has received a five year, $15 million grant along with a $50 million donation in drugs, to treat hepatitis C in Hazard and Perry County in order to examine the concept of "treatment as prevention."

Hepatitis C is a contagious liver disease caused by a virus that is primarily spread by injection drug users when they share needles or other equipment. Left untreated, it can lead to cirrhosis or liver cancer.

Jennifer Havens

The Kentucky Viral Hepatitis Treatment Project, led by Jennifer Havens at the UK Center on Drug and Alcohol Research, will provide treatment to 900 Perry County drug users who have hepatitis C. They have already been identified through Havens' previous work in the county around drug addiction.

Havens told the UK Board of Trustees, at a day-long meeting devoted to the issues of opioid abuse, that it's important to treat people who test positive for hepatitis C in drug-using networks as a way to prevent its transmission.

"Once they are cured, they are no longer transmitting," she said Thursday. "So it makes a whole lot of sense to use this treatment-as-prevention approach. It lowers the community viral load."

Havens said the project's goal is to increase access to hepatitis C treatment in rural Appalachia by removing the barriers to care, such as cost, insurance restrictions and poor access to specialists.

The project will also cover the cost of substance-use disorder treatment for each of the participants and a case manager to help with any additional barriers to care, such as transportation. It will also cover the cost of the Perry County Health Department's syringe exchange during the study period.

Havens said the treatment will reduce the future health-care burden in a region that already has such vast health disparities. Ultimately, she said she plans to use the evidence gathered from the research to build new models of hepatitis C care across the nation.

Funding for the project comes from the National Cancer Institute and the National Institute on Drug Abuse. Also, Gilead Sciences Inc. will donate 900 doses of the costly hepatitis C anti-viral drug, valued at $50 million.

As the FDA plans to approve sale of a super-strong painkiller, a Kentucky doctor with authority in the field objects

By Al Cross
Kentucky Health News

A Kentucky doctor with expertise in the field is objecting to the Food and Drug Administration's plan to approve for sale a painkiller stronger than fentanyl, an opioid that is deadly even in very small doses.

Dr. Raeford Brown

Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, is the longtime chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. The panel voted 10-3 on Oct. 12 to support approval of a form of sufentanil branded as Dsuvia. Brown said he was unable to attend that meeting, but sent the panel a statement saying why sufentanil "represents a danger to the general public health and will make our job of protecting Americans more difficult." He explained the reasons for his opinion:

"Once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health. Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market."

Because sufentanil is so potent, it is given in "quite small" doses and easy to divert to illegal use, Brown warned. "I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market." Sufentanil is 500 times stronger than morphine.

The FDA says it can require the drug to be used only in "closely controlled settings," Brown wrote, but "In order to have this happen, the education of all prescribers would need to be guaranteed. This has not been demonstrated with any other opioid, and, given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label."

Brown's statement was part of a letter from the nonprofit public-interest group Public Citizen that criticized the FDA for not having its full Drug Safety and Risk Management Advisory Committee participate in the meeting of his committee, "predictably increasing the odds of a vote favoring FDA approval." The letter also said the FDA made "an unrealistic and dangerous decision . . . that the two major safety problems causing the agency to reject sublingual sufentanil tablets in 2017 were no longer a barrier to its approval and that the benefits thereby outweigh the risks."

Dsuvia’s manufacturer, AcelRx Pharmaceuticals Inc., says its 30-microgram tablets are no stronger than any other opioid already available in the U.S. It says the design makes it easier for use on a battlefield, "and could help elderly or obese patients, for whom an intravenous opioid can be difficult and oral opioids take some time to start working," Emma Court of Marketwatch reports.

Medicare open enrollment runs through Dec. 7; here's more advice, including a book by a former Kentucky business editor

"For those approaching Medicare or already covered by it, now is a critical time of year to review health benefits," Sally Squires writes for The Washington Post. "Several changes are coming in 2019, including to Medicare Part D drug coverage insurance and to some Medicare Advantage plans, which are offered by private insurance companies and are known as Medicare Part C."

So, it seems "more important than ever for Medicare recipients — and anyone approaching age 65 — to begin looking at all the details right now, during Medicare’s open enrollment period, which began Oct. 15 and ends Dec. 7," Squires writes. "This is the prime time of year when changes can be made in a plan without penalty. There are a lot of different plans that can work better or worse depending on your health status and finances. Experts say you should choose a plan that will not just take care of your health needs today but also what they could be in 10 years."

One such expert is Philip Moeller, a former business editor of the Louisville Courier Journal, who is the author of a popular book, Get What’s Yours for Medicare: Maximize Your Coverage, Minimize Your Costs, which Squires notes.

Squires details some important elements of Medicare, such as Part A, "which covers inpatient hospital care, short-term care in a skilled nursing facility, hospice care and some in-home care." Most people pay no Part A premiums because they Medicare taxes have been deducted from their paychecks for at least 10. "Part B premiums range from about $134 per person per month to $429 per month for those earning about $160,000 as an individual or more than $320,000 for a joint tax return," Squires notes. "The cost of Part C Medicare Advantage plans varies by the company offering the plans and benefits covered." And look carefully at those plans, beyond premiums to deductibles and co-payments, advises Trudy Lieberman of the Rural Health News Service.

Also, it's important to remember that "Medicare covers most, but not all, costs," Squires writes. "For 2018, the Part A deductible that a patient must cover is $1,340 for each hospital admission during the year. For extended hospitals stays beyond 61 days, there are additional costs of at least $335 per day that recipients pay."