FDA wants to limit number of hydrocodone refills available without another doctor visit; approves pure version of drug

"The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers, changes that are expected to take place as early as next year," Barry Meier reports for The New York Times. "Drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab." (Associated Press photo by Toby Talbot)

"Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems," Meier writes. "The change would reduce the number of refills patients could get before going back to see their doctor. Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in. The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription."

On Friday, the FDA announced it had approved a stronger version of hydrocodone, Zohydro ER, for patients who require 24-hour, long-term pain medication. "The new version is the first pure hydrocodone drug approved in the U.S.," ABC News reports. "Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines." Activists against prescription-drug abuse criticized the decision.

U.S. Rep. Hal Rogers of Kentucky's 5th District "said on Friday that top FDA officials had recently assured him they would only approve new opioids like Zohydro if they were marketed in formulations intended to deter abuse," Meier and Eric Lipton report. "OxyContin is now formulated that way, but Zohydro, which is contains hydrocodone without acetaminophen, is not. Its producer, Zogenix, says it will closely monitor use of the drug." Rogers told the Times, “It is like the original OxyContin, so that is real problematical.”        

More than 6.1 million Americans abuse prescription pills, and last year there were 22,133 prescription drug deaths. The problem is most rampant in Central Appalachia, including Eastern Kentucky.

In 2011, about 131 million prescriptions for 47 million patients, or about five billion pills, were written for medications containing hydrocodone, Meier notes. "Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from narcotic painkillers, or opioids, quadrupling since 1999, according to federal data." (Read more)

Kentucky, insurance companies are applying lessons learned in state's hurried transition to managed-care Medicaid

By Molly Burchett
Kentucky Health News

Gov. Steve Beshear rushed to transplant Medicaid into a new bed called managed care, hoping the new medium would save money and improve health, but his administration didn't take time to condition the soil, fertilize the ground or oil the machinery in 2011. This month, managed-care company Kentucky Spirit proved to be the self-plucking bad weed, fleeing the state as it cited unbearable costs.

Kentucky’s hurried transition to Medicaid managed care has been anything but smooth for many doctors, hospitals and other health-care providers. They have complained about late payments and burdensome reimbursement processes.

It's also not been smooth for the state or the managed-care firms, which are subsidiaries of insurance companies. There have been court battles, tension-filled negotiations, dropped contracts, allegations of a contract breach and now the departure of Kentucky Spirit, pushing its 125,000 clients to one of the other two companies operating outside the Louisville region.

Most important, patients have suffered from the rapid switch and ensuing wrangles.  They complain that prescriptions previously covered by the old "fee for service" system are now denied as not being"medically necessary" by managed-care firms, which the state pays a set fee per person. Patients in rural areas complain because they must drive long distances to find providers in their Medicaid company's network.

But there have been improvements in delivery of health care, particularly in the areas of vaccinations and other preventive services, says the state Cabinet for Health and Family Services. Those include a 33 percent increase in flu vaccinations and an increase in immunizations for children, more well-child visits, increased smoking-cessation consultation, and more than a 50 percent increase in diabetes testing, cabinet spokeswoman Jill Midkiff said.

State and companies made some missteps

Amid those encouraging signs for the future, most of the news about managed care in the past 10 months has been about Kentucky Spirit's potential departure  which occurred July 6. The cabinet is preparing legal action to seek damages from Kentucky Spirit for abandoning its contract; the company, a subsidiary of St. Louis-based Centene Corp., says it didn't break the contract and took every step possible to make a smooth and orderly transition. The state Court of Appeals ruled that Kentucky Spirit could end its contract without a two-month transition period for patients because the state had plenty of time to make arrangements for the company's departure.

It's not clear that the state can recoup damages, or lost taxpayer money, from Kentucky Spirit, though it is having to pay the other two companies more because Kentucky Spirit was initially the low bidder for a managed-care contract. CoventryCares and WellCare of Kentucky are paid an average of about $100 more per month per Medicaid patient.

When Kentucky Spirit first threatened to leave in October 2012, it said it was losing money due to "faulty data" the state provided during the bid process. The two other companies received the same information.

"There were no flaws in the state's data book," CoventryCares CEO Michael Murphy told Kentucky Health News. But he said the companies miscalculated because the data book didn't refer to retroactive payments. That led to a loss of $50 million for Coventry in the first quarter of 2012, he said. Now, he added, the company has a greater understanding of the system.

WellCare, asked if the state provided faulty data, did not answer as definitively. "Medicaid programs are expansive and complex, and it is not unusual for any state to provide data during a RFP [request for proposals] process that may have anomalies or other issues that could negatively impact rates if left unaddressed over time," said Mike Minor, president of the firm.

Schedule seemed politically influenced

Both companies said the state's transition to managed care was rapid and taught difficult lessons. That raises questions about whether haste made waste. Kentucky Spirit blames the state for its losses, and providers blame managed care companies for reimbursement issues, but evidence continues to clearly indicate two problems: too little time and money.

The state has been using managed care in the Louisville region through the not-for-profit Passport Health Plan since the late 1990s, and had long considered expanding it to other parts or all of the state to save money as Medicaid costs burgeoned, especially during the Great Recession.

Gov. Steve Beshear proposed statewide managed care in the budget he gave the General Assembly in early 2011, called a special legislative session to authorize it in March 2011, and signed the legislation on March 25 of that year. The state requested proposals from managed-care companies two weeks later, and bids were due less than two months later.

Contracts were finalized July 8 but implementation was not scheduled until Oct. 1. It was delayed until Nov. 1 "at the insistence of the Kentucky Hospital Association," which "asserted more time was needed for hospitals to negotiate contracts with plans," says a University of Kentucky report published last year and funded by the Foundation for a Healthy Kentucky.

"Several informants told us that they believed that the upcoming election for Kentucky’s race for governor was a primary contributing factor in the rapid implementation timeline," the report says. "Beshear’s office saw the closing of this gap as a major issue that needed to be addressed before the November election," which was held Nov. 8. That effectively delayed most publicity about complaints regarding implementation until after the election.

"There is no doubt that the commonwealth’s rapid transition from a Medicaid fee-for-service program to a managed-care program raised a number of unforeseen challenges," said Minor, of WellCare.

"Certainly, the short timeframe . . . made for a difficult transition," said Midkiff. "Despite the negative portrayal of the managed-care companies, much progress has been made . . . and we expect that progress will continue."

Implementation timeline from UK's Medicaid managed care report

In October 2012, the managed-care companies continued to be dissatisfied with their fees, claiming they were inadequate to provide quality care, says the UK report. In January 2013, the state gave CoventryCares and WellCare 3 to 5 percent rate increases.; Kentucky Spirit asked for 21 percent, Murphy said, but got only 1 percent.

Murphy said the state had reduced rates below those established by the federal Centers for Medicare and Medicaid Services. "We want to establish base rates for primary care services that we hope the state will continue," he said.

Minor said, "While there were legitimate prompt-pay issues during the first six months of implementation of Medicaid managed care, we are now well past those issues."

Looking ahead

Murphy said some of CoventryCares' initial failures were due to the company's lack of understanding, and it has found Health and Family Services Secretary Audrey Haynes and her actuaries very cooperative and transparent, helping improve the system. "CoventryCares had to first figure out the problems going on with providers and payments. We had to understand the risks we had, and things have settled down quite a bit, especially regarding the pre-authorization process," he said. "We've stopped the bleeding."

Murphy said health-care providers will bear the burden of Kentucky Spirit's departure. To resolve issues faced by providers even before that, the cabinet has held regional forums across the state. Reception at the forums has been positive, and providers have been grateful for the opportunity to address any problems or complaints they have with the cabinet and Medicaid staff, said Midkiff.

Some providers still complain, saying that they should not have to meet with managed-care and state officials to receive payment for services already provided to Medicaid patients.

Starting in January 2013, primary care providers were supposed to be paid Medicare rates for Medicaid services over a two-year period, but some providers have yet to see that rate increase. Murphy said Coventry is planning to pay the increased rates as soon as the state's application is approved by federal officials.

Murphy said managed care should not be about the money, but about the member. He said primary care is at the core of improved health outcomes. Minor said WellCare has also made it a goal to establish relationships with primary-care providers.

But for those primary-care providers facing financial difficulties in wake of payment cuts, it is about the money because they need it to keep their practices open.

One of providers' latest complaints is CoventryCares' recent limit on dispensing certain prescription pain killers, to a 15-day supply. The move was made "to curb the manipulations going on with opioid painkillers," said Russell Harper, the company's director of government relations.

Murphy said, "It's not everybody, but there are physicians that don't want to engage in health care." He acknowledged that the prior-authorization process between doctors and pharmacists can be a hassle, but it's just another facet of managing the health care of Medicaid patients. That, and saving money, are what managed care is all about.

Prescription drugs killing more women than ever; Kentucky ties for fifth for its high percentage of deaths

The ongoing national epidemic of addiction to prescription painkillers is spreading more quickly among women, and it is killing more women than ever before. Kentucky ties Utah for the fifth highest percentage of female deaths due to prescription-drug overdose (15.7 percent), says a new government report.

Opioids, or prescription painkillers, are the leading cause of drug-overdose deaths among women, accounting for 70 percent of overdoses. And, although men are more likely than women to die from drug overdose and Kentucky has the highest rate of male deaths in the country (25.9 percent), the percentage increase in the rate of overdose deaths from 1999 to 2010 was greater for women (151 percent) than for men (85 percent). During that period, there was a 415 percent overall increase in opioid painkiller-related deaths among women, compared with a 265 percent increase among men, says a Centers for Disease Control Vital Signs report released last week. (CDC graphics)

Since 2007, more women have died from drug overdoses than from motor-vehicle traffic injuries and about five times as many women died from prescription-painkiller overdoses in 2010 as in 1999. About 6,600 of those deaths occurred in 2010 alone, and prescription painkillers are reported to be involved in one of every 10 suicides among women, says the report.

Across the nation, about 18 women per day die from prescription drug overdose and every three minutes, a women goes to an emergency room for prescription-painkiller misuse or abuse, which is more likely to occur in women between the ages of 25 and 54. The report also says the rise of deaths from prescription drugs relates closely to increased prescribing of these drugs during the past decade.

States can take action against the dangers of prescription drug abuse by increasing access to substance abuse treatment while reducing barriers to getting such treatment, says the report. It is also important to educate health care providers about effective pain treatment options and to educate the public about the risks and benefits of taking prescription painkillers. Click here for a PDF factsheet from the CDC.

Deadly, recalled pills still circulating in Pennyrile Region

A pain reliever that has been recalled and declared dangerous by the Federal Drug Administration is still circulating around southern Kentucky.

The drug marketed under the name Reumofan Plus is being distributed in Elkton and the broader Pennyrile Region, despite being recalled, and a local doctor's office says patients on the drug have had dangerous side effects, reports Nick Tabor of the Kentucky New Era.

Dr. Keith Toms of Generations Primary Care told Tabor three of his patients have taken the drug and had bad side effects. One patient had dangerous elevations of liver enzymes, and two diabetic patients had dangerous spikes in blood sugar.

The Food and Drug Administration has received reports of deaths, strokes, severe internal bleeding, dizziness, insomnia, high blood sugar and other problems associated with the drug since June. The manufacturer, operating under the names Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month, reports Tabor.

According to the FDA, undeclared ingredients in the drug, which is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, could result in serious illness. Tabor reports a FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.

Tabor reports the FDA has issued an alert telling consumers to stop taking the drug immediately and consult a health-care professional. The agency also said it may follow up on the Reumofan recall with warning letters, seizure, injunction requests or criminal charges. (Read more)

Beshear calls for action to improve state's health, but says only that 'It's time for us to begin looking seriously' at a smoking ban

By Al Cross
Kentucky Health News

His priorities were education and tax reform, but Gov. Steve Beshear mentioned several health issues in his State of the Commonwealth speech tonight to a joint session of the General Assembly.

Beshear called for action to correct the state's "fundamental weaknesses," including "a population whose health ranks among the worst in the nation." Near the end of his speech, he said, "We need to continue improving the health of our people," but after about a minute of discussing tobacco and smoking he stopped short of endorsing a statewide ban on smoking in the workplace. (KET photo)

"It's time for us to begin looking seriously at doing this on a statewide level," he said to some applause, after noting that nearly half of Kentuckians live in jurisdictions where smoking is legally restricted, that the state has the highest or next-to-highest smoking rate overall and among teens and pregnant women, and that "Our smoking-related mortality rate is the worst in the nation. . . . Our addiction hurts productivity, jacks up health care costs and kills our people."

Beshear called for improving prenatal care and newborn screening, and for minor improvements in last year's bill to fight prescription drug abuse. He said the bill has caused a precipitous drop in abuse of prescription painkillers. "Kentucky at one time had the sixth highest rate in the nation, but . . . we improved 24 spots," he said. "Nearly half of the state's known pain management clinics have closed rather than submit to new rules that protect patients." He said use of the Kentucky All Schedule Prescription Electronic Reporting system "has increased nearly seven-fold . . . and prescriptions for some of the most abused drugs have dropped up to 14 percent from a year ago."

However, the problem of babies becoming addicted to drugs in their addicted mothers' wombs has skyrocketed in the last decade or so, Beshear said: "In 2000, reports showed 29 babies in Kentucky born addicted to drugs. But in 2011, there were 730 babies – more than 25 times as many. And that figure is thought to be under-reported." He did not say how he wants to improve screening.

Beshear did not mention perhaps the biggest health policy question facing the commonwealth, whether to use federal subsidies to expand the Medicaid program to people in households earning up to 138 percent of the federal poverty threshold. Now the program covers people in households earning up to 70 percent of the poverty line. The federal government would pay all the cost of the additional enrollees through 2016, when the state would start picking up part of the tab, up to 20 percent in 2020.

Some Republicans say the state can't afford the expansion, while some Democrats say it would be a good long-term investment in the state's health and economy. Beshear has said he wants to do it if the commonwealth can afford it, and expects to get cost estimates around the end of March -- about the time the legislature must adjourn.

For a PDF of the speech text, click here. For an audio recording, go here. For video from KET, here.

FDA likely to make hydrocodone painkillers harder to prescribe

Prescription painkillers containing hydrocodone should be placed in a more restrictive federal category, a Food and Drug Administration advisory panel of experts voted on Friday. The changes would be an effort to stem the tide of prescription painkiller abuse and addiction in the U.S., much of it in rural areas, beginning in Central Appalachia. Painkillers containing hydrocodone are the most widely prescribed drugs in the country.

Sabrina Tavernise of The New York Times reports the FDA is likely to adopt the panel's recommendations, which include limiting access to hydrocodone drugs such as Vicodin by making them harder to prescribe. Refills wouldn't be allowed without a new prescription, and faxed or called-in prescriptions wouldn't be accepted. Only a hanwritten prescription from a doctor would be allowed, and pharmacists would be required to keep the drugs in special vaults.

Many said these changes would be a key step in reducing painkiller addiction. However, dissenters in the vote were concerned that this move wouldn't make a difference. Oxycodone, the main ingredient in the highly-abused painkiller OxyContin, has been classified in a restrictive category since it was first introduced on the market but it is still widely abused, dissenters said. They also said the change could create unfair obstacles for legitimate patients. (Read more)

Poll shows depth of prescription drug abuse in Kentucky

By Molly Burchett and Al Cross
Kentucky Health News

One-third of Kentucky adults have friends or relatives who have experienced problems from abusing prescription pain relievers, and 8 percent have used pain medicine when it wasn't prescribed or for the feeling it caused, according to a statewide poll conducted last fall.

The Kentucky Health Issues Poll found that in Eastern Kentucky, 45 percent reported that prescription drug abuse have caused problems for friends or family members. In the 17-county Bluegrass Area Development District, which includes some Appalachian counties, the figure was 37 percent. It was 32 percent in Northern Kentucky, 31 percent in the seven-county Louisville area and 25 percent in Western Kentucky.

The poll found that young adults are more likely to have the problem. Among those 18 to 29 years old, 13 percent said they had used pain medicine when it wasn't prescribed or for the feeling it caused, and 49 percent said they had a friend or relative who had been affected.

The Foundation for a Healthy Kentucky, which co-sponsored the poll, noted that drug-overdose deaths in Kentucky correspond to a steep increase in the sales of opioid prescription pain relievers, which include OxyContin, Vicodin, Percocet and codeine. More than half of Kentucky adults in the poll reported being prescribed such drugs.

“While these types of medications are important for controlling pain in patients who need them, opioids also carry the potential for abuse,” said Dr. Susan Zepeda, President and CEO of the foundation. “Our state ranks sixth in the nation for prescription pain reliever overdose deaths, and these data provide a window on how many Kentuckians are impacted – directly or indirectly – by prescription misuse.” (Read more)

The poll was conducted for the foundation and The Health Foundation of Greater Cincinnati from Sept. 20 through Oct. 14 by the Institute for Policy Research at the University of Cincinnati. A random sample of 1,680 adults throughout Kentucky was interviewed by landline and cell telephones. The poll's margin of error is plus or minus 2.5 percentage points.

Kentucky Health News is an independent service of the Institute for Rural Journalism and Community Issues at the University of Kentucky, with support from the Foundation for a Health Kentucky.

Painkiller epidemic was driven in part by drug makers' financial relationships with researchers who discounted the risks

For almost a decade, medical officials and experts claimed OxyContin rarely posed problems of addiction for patients. The drug's label, which was approved by the Food and Drug Administration, said addiction risks were small. Research published in the New England Journal of Medicine also said OxyContin wasn't addictive; so did a study in another journal, which OxyContin manufacturer Purdue Pharma reprinted 10,000 times. Since the drug first hit the market, it has fueled a large-scale swath of prescription pain killer addiction, beginning in Central Appalachia, that has grown into a national epidemic, especially in rural areas.

The epidemic was driven in no small part by doctors' lack of knowledge about OxyContin, which was perpetuated by the drug's manufacturer through false claims that became scientific consensus. But now, "Many in the medical profession have rediscovered the destructive power of opiates," and are calling that consensus into question, Peter Whoriskey of The Washington Post reports. "A closer look at the opioid painkiller binge, in which retail prescriptions have roughly tripled in the past 20 years, shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice."

Doctors were wary of prescribing painkillers to any patient except those with cancer for years. But manufacturers and some pain specialists "helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain: bad backs, arthritis, sore knees," Whoriskey reports.

Through an examination of key scientific papers, court documents and FDA records, the Post found that many of the studies claiming OxyContin wasn't addictive were supported by Purdue Pharma. The conclusions those studies reached were sometimes not supported by data, and when the FDA needed to develop an opioid policy, it turned to a panel of doctors who had financial relationships with Purdue Pharma and other drug makers. (Read more)

Generic OxyContin and Opana, headed for market soon, could make fight against pain-pill abuse tougher, McConnell says

With generic versions of the two most commonly-abused painkillers, Opana and OxyContin, coming on the market next year, police, hospitals and health clinics in Kentucky have voiced concern that "these generic crushable drugs lack the tamper-resistant gel coating of the brand-name drugs," says a news release from U.S. Sen. Mitch McConnell.

"Without this technology, addicts crush the pills in order to achieve an immediate heroin-like high from sniffing or injecting the painkillers," the release says. "If these generics come to market without the tamper-resistant coating, much of the work that law enforcement and health care providers have done to stem the tide of pain pill abuse in Kentucky will be lost."

McConnell's news release said he has asked the Food and Drug Administration to keep the crushable drugs off the market "until a workable solution can be found." McConnell, the Senate Republican leader, met Wednesday with the Department for Health and Human Services’ acting general counsel, Bill Schultz, to discuss the issue. (Read more)

UK music therapy helps manage surgical anxiety, pain, recovery

A University of Kentucky study has found that music therapy can reduce pain before, during and after a surgical procedure, and shorten recovery time. The study report, published in the Southern Medical Journal, showed music was also useful in managing surgical anxiety. According to Lori Gooding, UK director of music therapy and lead author of the report, the music should be selected by trained personnel with a mind toward specific guidelines for music selection in order to maximize its positive effect on patients, though the patient's musical tastes should still be considered. Gooding suggests patients be offered several playlists from which to choose so they can have something to suit their tastes as well as the medical protocol. (UK video)



Gooding writes that the tempo, rhythm and volume of the music should be carefully controlled to maximize its effect. Calm, slow, gentle music was shown to produce the most positive results and facilitate relaxation and pain reduction in patients. UK began providing music therapy for patients in Kentucky Children’s Hospital, UK Chandler Hospital and UK Good Samaritan Behavioral Health in October 2010. The UK Music Therapy program was established as part of the Lucille Caudill Little Performing Arts in HealthCare Program, a unique partnership between the UK School of Music and UK HealthCare. (Read more)