Ky. has 54 counties at high risk for spread of HIV and hepatitis C among IV drug users but only 6 of them have needle exchanges

By Melissa Patrick
Kentucky Health News

Why, if 54 of Kentucky's 120 counties are among the nation's most vulnerable to outbreaks of HIV and hepatitis C among intravenous drug users, do only a few of them allow users to exchange used syringes for clean one to avoid spreading the diseases?

That question was asked, implicitly, by a national expert who spoke at the 2016 Viral Hepatitis Conference in Lexington July 26.

"I think it is very interesting to compare the counties we believe are at risk, based on our modeling, and then where are prevention services, such as syringe-service programs," said Dr. John Ward, director of the Division of Viral Hepatitis at the federal Centers for Disease Control and Prevention. "You can see there is a big disconnect, that there is a big gap in syringe service availability and other powerful prevention interventions, such as medication-assisted therapy."

Syringe exchanges were authorized in Kentucky under a 2015 anti-heroin law and require local approval and funding. They are meant to slow the spread of HIV and hepatitis C, which are commonly spread by the sharing of needles among intravenous drug users.

So far, 14 counties have approved syringe exchanges, according to the Cabinet for Health and Family Services, with 11 of them operating. But only six (Carter, Boyd, Pike, Knox, Mercer and Grant) are in the most-vulnerable group.

A spokeswoman for the state Department of Public Health said the agency supports the exchanges and is available to provide support, share best practices, offer technical guidance, and provide information on their effectiveness and benefits.

"In addition, DPH has hosted several statewide conference calls with local health department directors to discuss setting up syringe exchange programs," spokeswoman Beth Fisher said. "We have also coordinated several trainings for syringe-exchange staff members as well as administrators. We also work to provide education and training regarding harm reduction related to syringe use to communities."

Dr. John T. Brooks, senior medical adviser for CDC's Division of HIV/AIDS Prevention, pointed out the HIV outbreak that occurred in Scott County, Indiana last year, which drew national attention because of its high rates of HIV and hepatitis C.

He said Scott County isn't that different from many rural Kentucky counties because of its high poverty and unemployment rates, low education and life expectation, lack of HIV and hepatitis C care, insufficient addiction services and no needle exchange when the outbreak began. The CDC found that 18 Kentucky counties were more vulnerable to a hepatitis C and HIV outbreak among IV drug users.

"If we don't pay attention to history, we are doomed to repeat it at some point in the future," Brooks said. "You want to prevent this from getting introduced and recognize it the moment it is introduced so that you can do what you can to prevent it from continuing to spread."

Ward said multiple approaches are needed to stop the spread of hepatitis C. Using the Scott County outbreak as a model, he said a syringe-exchange program would decrease hepatitis C by 27 percent; adding medication-assisted therapy would make the decrease 41 percent; and adding a robust testing and treatment program would get it to 71 percent.

Brooks said syringe exchanges and medication-assisted therapies would reduce the potential spread of new HIV infections by 64 percent and 56 percent, respectively.

He encouraged Kentucky counties to gather their own data to determine the prevalence of IV drug use in their communities; to test people with substance-use disorders in jails and prisons, and those who frequent emergency rooms, for HIV and hepatitis C; and to create a countywide plan for a potential HIV or hepatitis C outbreak.

Referring to resistance to syringe exchanges, Wayne Crabtree of the Louisville exchange asked, "When has judgement, stigma or shaming ever made a difference in someone's life? When did it ever change behavior? I would say never. And we in public health know it is the hand reaching out to someone in need lifting them up and making them realize their self-worth that elicits change."

Dr. Ardis Hoven, a state infectious-disease expert, said "Stigma continues to exist everywhere around many of the issues we are discussing today and I think it is our responsibility and our challenge to begin to open up the dialogue in a way that goes to minimizing it. Because as stigma is sitting out there, we are not going to be able to get the job accomplished as well as we should."

Hoven said establishing a syringe exchange requires local data and local allies, especially local police, who can "make or break a syringe-exchange program."

Read More

The Wages of Sin - a Small Illustration of How Executives Can Personally Profit from Bad Corporate Behavior in Health Care

The resolution of two related cases involving drug/ biotechnology/ device giant Johnson and Johnson opened a small window on the perverse incentives driving bad managerial behavior in health care.

The Settlement of the Allegedly Illegal Marketing of the Stratus Device

The basics of the case, which looks like a typical marcher in the march of legal settlements, were best explained by Ed Silverman in Stat on July 22, 2016,

A Johnson & Johnson subsidiary has agreed to pay $18 million to resolve charges of causing health care providers to submit false claims to Medicare and other federal health care programs, which then paid for a device that was illegally marketed.

In particular,

In 2006, Acclarent won FDA approval to market its Stratus device to be used only with saline to maintain sinus openings following surgery. But the feds alleged the company intended to market Stratus as a drug-delivery device for prescription corticosteroids and maintained the device was specifically designed and engineered for this use, according to court documents.

Note that as is usual, the settlement involved a monetary penalty that would not even be spare change to Johnson and Johnson, which last year had total revenues of more than $70 billion according to Google Finance.  As is additionally usual, the settlement did not seem to be informed by Johnson and Johnson's huge record of previous settlements and other legal actions suggesting its misbehavior (see a list of these in the appendix below.)  As is also usual, the settlement involved no admissions of guilty or innocence by Johnson and Johnson itself, but as is further usual, a company public relations person said it was a long time ago, we have changed, and we will just move on.  As the Wall Street Journal reported,

A spokeswoman for Johnson & Johnson said the company has since put in place tighter compliance controls. She noted the agreement, which didn’t include an admission of liability or wrongdoing, resolves alleged conduct that took place almost entirely before Johnson & Johnson acquired Acclarent.

Two Johnson and Johnson Executives Convicted of Distributing Misbranded and Adulterated Devices

But one part of this case was unusual.  Not only did US government authorities pursue a settlement with Johnson and Johnson, they prosecuted two executives who were involved in setting up the bad behavior alleged in the settlement.  Per Mr Silverman in Stat,

The settlement with the US Department of Justice, which was disclosed on Friday, comes just two days after a pair of former executives at the J&J subsidiary, which is known as Acclarent, were found guilty of several misdemeanor charges of distributing a misbranded and adulterated device. A federal court jury in Boston found the executives marketed the Stratus device for a use that was not approved by the US Food and Drug Administration.

So while the Johnson and Johnson spokesperson denied that the company was guilty of anything, it appears that two people who eventually became Johnson and Johnson executives were found guilty of having a company that Johnson and Johnson acquired distribute a misbranded and adulterated device.  At best, the spokesperson seemed to be asserting a distinction in the absence of a meaningful difference.      

Especially, since the allegations that led to the convictions of the executives included actions that occurred after their company was acquired by Johnson and Johnson, per the Stat article,

Between 2008 and 2011, the men allegedly concealed a scheme to illegally distribute and promote a device they planned to market for delivering steroids to sinuses. The feds charged, however, they deceived the FDA by falsely claiming the intended use was to maintain an opening to the sinus, and that the device was supposed to be used with saline.

Acclarent, where Facteau was the chief executive and Fabian was the vice president of sales, was eventually sold to Johnson & Johnson in January 2010 for $785 million. Following the acquisition, Acclarent management was told to stop marketing the device for unapproved uses, but they continued to do so anyway, court documents stated.

So why would Mr Facteau and Fabian do this?  An article in Reuters implies an answer:

Prosecutors said Facteau and Fabian had hoped to increase the company's revenue to make it an attractive acquisition target, and concealed the off-label marketing from potential buyers, including J&J unit Ethicon Inc.

Ethicon bought California-based Acclarent in early 2010 for about $785 million. Facteau and Fabian received compensation worth about $30 million and $4 million, respectively, from the deal, according to the indictment.

So the former Acclarent executives, later Johnson and Johnson subsidiary, made what seems to be a lot of money from directing their company to distribute a misbranded and adulterated product.  In fact, they made considerably more money than Johnson and Johnson paid to settle the case.

Conclusions

So this case appears to be a step forward, in that not all the people who apparently authorized, directed, or implemented the bad behavior could escape any negative consequences.  Keep in mind, however, that no one above the two convicted executives, no one at Johnson and Johnson who decided to acquire Acclarent, and let it continue its previous activities, seemed to suffer any negative consequences.  How much money those executives might have received in response to the revenues that the new subsidiary brought in is unknown.

In conclusion, this case shows the perverse incentives at work that drive bad behavior by health care oragnizational leaders.  One can obviously become very rich by directing this bad behavior.  Up to now, the likelihood that one would eventually pay any penalty for doing so was tiny.  Now it is slightly higher.  Whether those up the ladder, who might have authorized the behavior, turned a blind eye to it, or avoided enquiring about anything that could be bad behavior, as long as the money came in, will suffer any negative consequences from these actions or inactions in the future is still unclear.

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it.  True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why.  But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position.  It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public. 

Appendix - Johnson and Johnson Legal Record since 2010-
2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
2012 
 - Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post). 
2015
-  Johnson & Johnson found by jury to have concealed harms of Risperdal.
-  Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
-  Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)

Read More

Updated directory of local health coalitions published

The Foundation for a Healthy Kentucky has released an updated directory of groups working on health in the state. It includes 230 groups representing all 120 counties as well as statewide coalitions doing work to improve the health of Kentuckians.

"These coalitions are largely local efforts involving neighbors and colleagues working on solutions to health issues where they live, work and raise their families," said Susan Zepeda, president and CEO of the foundation. "Our aim in keeping this directory updated is to raise awareness of efforts to improve health in local communities  and across the state, foster collaboration among the coalitions, increase their capacity to make a difference, and celebrate their successes."

The groups have differing goals and levels of organization. For example, some are increasing access to healthy food and physical activity; others are planning screenings and education for people at risk for serious health problems such as cancer, diabetes and other chronic diseases; others are improving the health of their communities through smoke-free or complete-streets ordinances.

Coalitions were identified by consolidating lists of known groups, reaching out at meetings and events, reviewing news clippings on local efforts, requesting additional entries from partner agencies, and conducting a web-based survey.  The directory is a living document, and the foundation welcomes established coalitions to share updates and new coalitions to be added. Contact Rachelle Seger, rseger@healthy-ky.org.

The 2016 Kentucky Health Coalitions Directory can be found on the foundation's website.

Read More

Analysis of Indiana Medicaid plan, model for Bevin, shows same concern about financial hardship voiced by Kentucky critics

Gov. Matt Bevin

By Danielle Ray
Kentucky Health News

While Republican Gov. Matt Bevin works on his proposal to reform his Democratic predecessor's expansion of Medicaid, the Indiana program that was his model is suffering mixed reviews from a recent analysis.

Bevin's administration has said it hopes to file his plan with federal officials in August. The changes are modeled after Republican Gov. Mike Pence's "Healthy Indiana Plan 2.0," which includes premium contributions, health-savings accounts, incentives for healthy behaviors and a benefit lockout for people who don't pay premiums. The Indiana plan took effect last year.

A state-funded analysis by an independent consulting firm, released in early July, illustrates one of the issues raised by Kentucky critics of Bevin's plan: possible financial hardship for those required to pay monthly premiums.

Indiana Gov. Mike Pence

Among top concerns regarding the Indiana program are the number of Medicaid recipients either locked out of benefits or losing dental and vision coverage for six months after failing to pay into their health savings account.

Among the 345,656 Healthy Indiana Plan 2.0 enrollees (as of January 2016), 2,677 above the poverty line were locked out for six months for failing to pay their contribution, and nearly 21,500 below the poverty line transitioned to basic Medicaid because of non-payment, Virgil Dickson reports for Modern Healthcare.

The report says more than 90 percent of people in the expansion have been able to continue their HSA contributions of $3 to $25 a month depending on income level, but almost half said they worried about being able to make the contributions: 16 percent said they always worried, 7 percent said they usually worried, 22 percent said they did sometimes, and 14 percent said they did rarely. Three percent said they didn't know and 38 percent said they never worried.

If federal officials approve the proposed changes in Kentucky, the state would make dental and vision coverage a reward, not a basic benefit. Recipients could gain the coverage, as well as non-prescription drugs and gym-membership subsidies, by enrolling in job training, volunteer work or health-related classes.

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

Also like the Indiana plan, most Kentucky Medicaid recipients would have to pay premiums of $1 to $15 a month. Failure to pay would result in a six-month lock-out period for those above the federal poverty level, though they could re-enroll if they catch up on their payments and take a financial- or health-literacy class. Those below the poverty level or who are medically frail and don't pay premiums would shift to a co-pay system and have $25 deducted from their rewards account, which could then be suspended.

Bevin's proposal says it "represents the terms under which the Commonwealth will continue Medicaid expansion" as established by Democratic Gov. Steve Beshear. Bevin has said that if federal officials don't approve it, he would end the expansion, which provides largely free health care for about 400,000 Kentuckians who were not covered before 2014.

Bevin has said that former Gov. Steve Beshear's Medicaid expansion is financially unsustainable. His proposal attempts to offset the state's costs with what he has referred to as "skin in the game" for Medicaid recipients, meaning that they must be more active in their health care. The federal government is paying all bills for Medicaid expansion enrollees through this year. Next year the state would pay 5 percent, rising in annual steps to the federal health-reform law's limit of 10 percent in 2020. The estimated cost of the state share in the two-year budget that begins July 1 is $257 million.

Read more here about Bevin's proposed changes, including premium payments and Medicaid deductibles.

Read More

Testing for colon cancer may detect it without colonoscopy

Dr. Morris Beebe III
(Photo from Baptist Health)

Colorectal cancer is the second leading cause of cancer deaths (after lung cancer) even though effective, inexpensive, non-invasive screening options have been developed, says a Corbin gastroenterologist.

When it comes to colorectal cancer screening, patients are often embarrassed or worried about potentially painful procedures, Dr. Morris Beebe III writes in a Lexington Herald-Leader column.

Two simple screening options can be done in the privacy of a patient's own home: fecal occult blood testing (FOBT) and fecal immunochemical testing (FIT). Each test requires only an "at home" kit, collecting samples from several bowel movements.

"It’s all very private," Beebe notes.

FOBT requires minor changes to a patient's diet, such as avoiding red meat right before the test; FIT does not.

"The idea behind these tests is to see if there are small amounts of blood hidden in the stool, suggesting pre-cancerous polyps or cancerous growths," he says.

If results show hidden blood, a follow-up colonoscopy can be used for diagnosis and treatment. Colonoscopy is widely recommended as one of the most effective screening tests, Beebe says, reducing the odds of colorectal cancer deaths by as much as 60 to 70 percent. Doctors can also remove any abnormalities that are found during the same procedure.

Doctors perform a colonoscopy by inserting a scope, a flexible tube with a camera, into the rectum and threading it through the length of the colon. Air is pumped into the colon to make viewing easier. The patient is given either general anesthesia or sedation, so the procedure is much less unpleasant than the description suggests, Beebe notes.

The federal Centers for Disease Control and Prevention recommend regular colorectal cancer screenings at age 50.

"These screenings can save lives by detecting cancer at a treatable stage or even preventing it in some cases," Beebe adds.

Read More

Dean of osteopathic medical school at Pikeville University is new president of American Osteopathic Association

Boyd R. Buser, D.O.

Boyd R. Buser, dean of the Kentucky College of Osteopathic Medicine in Pikeville, is the new president of the American Osteopathic Association. The organization represents the professional interests of the nation’s more than 123,000 doctors of osteopathy and osteopathic medical students.

“We are at a turning point in health care, when the focus on wellness and prevention has never been greater,” Buser told the group at its meeting Saturday in Chicago. “Patients value our approach, how we partner with them to promote their health and well-being, whether the topic is preventing chronic disease or protecting patients from the threat of opioid addiction. As osteopathic physicians, we seek health in our patients and recognize that a person’s state of health depends on their body, mind and spirit.”

Buser is past president of the American Academy of Osteopathy. In addition to heading the osteopathic school at the University of Pikeville, he is the university's vice president for health affairs. He is best known for helping shepherd the profession through the transition to a single accreditation system for graduate medical education.

Read More

Consumer Alert for Individuals and Employer Groups Insured by Land of Lincoln Health

Land of Lincoln Health insurance coverage will end for consumers as of October 1, 2016.  Land of Lincoln is no longer offering health plans for individuals on the Federal Health Insurance Marketplace (HealthCare.gov). Land of Lincoln has also stopped offering health plans for employer groups. Please note: it is very important that until October 1, 2016, consumers and employers must continue paying premiums.

Below is an excerpt from the Land of Lincoln Health website instructing consumers and employer groups on coverage options:

IL Department of Insurance Director Dowling has been working with the Centers for Medicare and Medicaid Services (“CMS”) for purposes of having a special enrollment period opened in order to allow individual insureds an opportunity to obtain replacement coverage during 2016 on the Federal Health Insurance Marketplace (HealthCare.gov). CMS will provide Land of Lincoln individual insureds with a special enrollment period (“SEP”) due to a loss of Minimum Essential Coverage (MEC).

Under this SEP,individual insureds have two options:

1. Individuals may report their upcoming loss of MEC to the Marketplace from August 2, 2016 through September 30, 2016 and enroll in a new plan for coverage commencing on October 1, 2016; or
2. Individuals may report their recent loss of MEC to the Marketplace from October 1, 2016 through November 29, 2016 and enroll in a new plan for coverage commencing on the first day of the following month.

It is important that individual insureds take note that if they enroll in a new plan on the Federal Health Insurance Marketplace prior to their loss of MEC they will have no gap in coverage or any financial assistance they’re receiving, but that if they wait until after they’ve lost MEC to enroll in a new plan there will be a gap in their health insurance coverage and any financial assistance they’re eligible for.

Employer groups should work with their agent or broker to explore their options. If you are an employer group that enrolled in a Land of Lincoln plan on the open market, please work with your agent or broker. Questions for Small Business Health Options Program (“SHOP”) customers can be directed to the call center for the SHOP Marketplace,which is part of HealthCare.gov, at 1-800-706-7893 (TTY711) Mon-Fri, 9 a.m. to 7 p.m. (ET). Agents and brokers may also use this number.

IT IS IMPORTANT THAT LAND OF LINCOLN INSUREDS CONTINUE TO RECEIVE HEALTHCARE SERVICES WITHOUT INTERRUPTION FROM LAND OF LINCOLN PROVIDERS. PROVIDERS WILL BE PAID FOR SERVICES DELIVERED TO LAND OF LINCOLN INSUREDS UNDER THEIR PROVIDER AGREEMENTS. CLAIMS FOR SERVICES SHOULD BE SUBMITTED AS USUAL FOR PAYMENT. PROVIDERS SHOULD NOT REFUSE SERVICE TO INSUREDS.

If you are denied services from a Land of Lincoln provider, please notify the Illinois Department of Insurance. Please call the Consumer Assistance Hotline at (866) 445-5364, and then submit your complaint in writing. Complaints may be submitted in the following ways:

• Online at http://insurance.illinois.gov/Complaints/file_complaint.asp
• By email at consumer_complaints@ins.state.il.us.
• By fax to (217) 558-2083
• By mail to 320 W. Washington Street, Springfield, IL 62767

Keep your originals and send only copies of information. For a printed copy of the Department’s complaint form, contact the Consumer Assistance Hotline at (866) 445-5364. When your complaint is received, a file number will be assigned and you will be sent written notification of that number. Please refer to the complaint file number when you call or write to the Department. To read the entire Land of Lincoln Health notice, visit their website and read their alert.

Read More

Latest sign of IV drug spread: Hepatitis C cases among Kentucky women of childbearing age more than tripled from 2011 to 2014

Centers for Disease Control and Prevention chart shows hepatitis C rates for Kentucky and U.S.

Hepatitis C among Kentucky women of childbearing age more than tripled from 2011 to 2014, while the national rate among that group was rising only moderately, the federal Centers for Disease Control and Prevention said July 22 in a report that "offers further evidence of growing problems in the state from intravenous drug use," Bill Estep writes for the Lexington Herald-Leader.

In 2011, the hepatitis C infection rate among Kentucky women aged 15-44 was 275 per 100,000. In 2011, it was 862 per 100,000 -- an increase of 213 percent. The national increase during the period was only 22 percent.

The CDC highlighted Kentucky because "the state had the highest incidence of acute hepatitis C infections from 2011 through 2014," Estep reports. "The report found that the rate of infants born to women diagnosed with hepatitis C went up 124 percent in Kentucky in that time."

But those numbers likely understate the problem, Estep notes: "The figures were based on data from a large commercial laboratory called Quest Diagnostics and birth certificates. The report said that having to rely on data from one lab means the figures might not represent the reality across the country or in Kentucky. The numbers for Kentucky are likely low, the report said. Official figures for 2015 are not yet available. However, health department officials said early indications suggest the trend will continue for 2015."

Health officials also told Estep that the statistics make a good argument for needle exchanges where IV drug users can get clean syringes instead of sharing dirty ones and transmitting diseases such as hepatitis or HIV, the virus that causes AIDS.

There is also a financial argument, Estep notes: "One course of the drug needed to treat hepatitis C costs more than $80,000, and the lifetime cost of treating HIV can be hundreds of thousands of dollars, health officials said. Hepatitis C is the top cause of expensive liver transplants, according to the CDC."

Estep reports, "Most people with hepatitis C don’t have physical symptoms, but of every 100 people infected with the virus, 70 or more will develop chronic liver disease and as many as five will die from cirrhosis or liver cancer, according to a CDC fact sheet. . . . The agency said people born between 1945 and 1965 should talk with a doctor about being tested for hepatitis C, and that people with risk factors such as IV drug use should be tested. It also recommends that health care providers assess all pregnant women for risk factors and test those who might be at risk."

Read More

Justice Department sues to block Aetna's takeover of Humana

Getty Images

The U.S. Department of Justice has filed lawsuits to block the sale of Louisville-based Humana Inc. to Aetna Inc. and of Cigna Inc. to Anthem Inc., on grounds that consolidation of the health-insurance market will reduce competition and hurt consumers. Observers expect a protracted court battle, involving negotiations with the department's anti-trust division, reports Grace Schnieder of The Courier-Journal.

"Of the two deals, analysts and investors see Aetna and Humana as having a slight chance to reverse the decision," report Caroline Humer and Carl O'Donnell of Reuters. Aetna "faces a tough but not impossible legal battle." Also, "Aetna may also gain some leverage if the Anthem-Cigna deal breaks up first, according to some antitrust experts."

The Justice Department's major focus in the Humana-Aetna case is Medicare Advantage, the alternative insurance for seniors. "The two companies now compete in more than 600 counties, nearly 90 percent of the counties where Aetna offers Medicare Advantage plans," Schneider notes. "That fierce competition has led to lower premiums, better benefits, better provider networks and improved coordination of care, the suit said." It also said smaller insurers "lack the scope and scale" to compete.

Reuters reports, "Aetna will argue in court that the Justice Department defined the market for Medicare Advantage too narrowly, which has caused it to see competition issues where they do not exist, Chief Executive Officer Mark Bertolini said in an interview. The government has failed to take into account that seniors can not only choose between Medicare Advantage plans sold by private players, but also have the government-run Medicare program as an option. . . . The Justice Department has already rejected that argument. However, Aetna will use evidence that the Obama administration envisioned Medicare and Medicare Advantage as direct competitors as it sought support for the Affordable Care Act passed in 2010."

Read More

Lexington baby tests positive for Zika virus but shows no effects

A baby born in Lexington showed antibodies for the Zika virus but no apparent effects of it, the Lexington-Fayette County Health Department announced Friday. It is Kentucky's 10th confirmed case of Zika, which can cause birth defects such as an abnormally small head and brain.

Health Director Kraig Humbaugh said the mother had traveled early in her pregnancy to an unspecified area known to have been affected by the virus. "Health officials say the infant's mother never described symptoms of illness," Victor Puente of WKYT-TV reports.

While the baby showed antibiodies for Zika, it showed no other evidence of the virus, and apparently fought it off, Puente reports. Humbaugh said the mother and child present no risk to public health. He said pregnant women, or those planning to become pregnant, should cancel or postpone travel to Zika-affected areas.

Read More

Health advocates, providers and faith leaders voice concerns about Medicaid plan; one says it's based on false assumptions

By Melissa Patrick
Kentucky Health News

FRANKFORT -- Health advocates, providers and faith leaders spoke out against Gov. Matt Bevin's proposed changes to the state's Medicaid program at a news conference July 20, saying it creates barriers to access, is too complex and is based on false assumptions.

"The proposed changes to Medicaid by Governor Bevin and his staff will impact the health and economic wellbeing of hardworking, low-income Kentuckians, families and our most vulnerable citizens across the Commonwealth," said Rich Seckel, executive director of the Kentucky Equal Justice Center.

The news conference was sponsored by KeepKYCovered, a campaign coordinated by Kentucky Voices for Health, an umbrella organization for groups focused on sustaining access to affordable health coverage in Kentucky.

Col Owens, a director of KVH and a retired Legal Aid lawyer, was one of the most vocal opponents of the Medicaid proposal, saying it is based on inaccurate assumptions.

He said the notion that low-income workers don't sign up for health insurance because they don't know how it works is false. He said it "has little to do with understanding insurance and virtually everything to do with affordability." He noted that the costs of health insurance and health care are rising faster than wages, which have remained stagnant for decades, and that fewer employers than ever are offering health insurance: 56 percent, down from 70 percent in 1980.

As for the idea that people need "skin in the game," as Bevin contends, Owens said, "Low-wage workers do not earn enough money to achieve economic stability for their families, and it is simply untrue, demonstrably untrue, that they have enough sufficient disposable, discretionary income in order to pay co-pays, deductibles or premiums."

As for the work requirements, he said, "It is a great fallacy to believe that low-income people must be forced to work by holding out goods or services for things that they need. ... The truth about Medicaid is quite the opposite: it is what allows people to work."

The Kentucky Center for Economic Policy found that more than half of Kentuckians who gained Medicaid through the 2014 expansion by then-Gov. Steve Beshear are working.

Bevin's proposed work and volunteer requirements were particularly upsetting to entrepreneurs and farmers, jobs that require long hours and often the need to work a second job to make ends meet.

“The work requirements of the new proposal feel like a slap in the face to hard-working families like mine,” Oldham Coutny farmer Bree Pearsall said in a prepared statement. “To assume that because I am low-income that I have an inferior investment in my family’s health is an insult. I would like to see the governor act with compassion, instead of creating a culture of shame for families who receive health care coverage through Medicaid.”

Tyler Offerman, 27, of Lexington, who recently started an outdoor-adventure company while working full-time in a restaurant, said the expansion of Medicaid “allowed me to follow the American dream, and it supports other young entrepreneurs in doing the same. To assume people like me are lazy or are mooches to the system is totally offensive. I am an entrepreneur. I am trying to create jobs, to create a living for myself, and the kind of  rhetoric that is coming out of the Bevin administration is very offensive.”

Under Bevin's plan, Medicaid recipients would be required to pay premiums, which initially range between $1 and $15. Non-payment would result in a six month lock-out for those who are above the federal poverty level, though they can re-enroll if they get current on their payments and take a financial- or health-literacy class. Those below the poverty level or who are medically frail and don't pay premiums would shift to a co-payment system and have $25 deducted from their rewards account, which is then suspended.

Father Dan Noll of the Catholic Conference of Kentucky said that the complexity of the plan would discourage access, and strongly opposed the premiums.

"Kentucky cannot sacrifice people because they are poor," Noll said. "Many more lower income individuals and families in Kentucky will lack the resources to meet the financial burdens of their healthcare under Governor Bevin's health-care plan. To these families, an increase in premiums, cost-sharing charges and a lock-out period will be significant barriers to obtaining coverage or seeing a doctor, much less a dentist or eye-doctor."

Dr. Eli Pennington Pendleton, a family practice physician in Louisville who cares for the poor, said he was "deeply troubled and dismayed" by the plan.

"I had people come to me with tears in their eyes, overjoyed that they were finally able to take charge of their health problems. I had people quit smoking, get their blood pressure and diabetes under control, get much needed glasses, and finally address long-standing dental issues. Many of these patients were able to then enthusiastically rejoin the work force," he said.

"I worry that Gov. Bevin's plan will erase all of this progress and more. We know that premiums tend to decrease overall coverage; we know that co-pays decrease frequency of visits and discourage people from seeking immediate care; lock-outs compromise the management of complex chronic disease and decrease downstream cost, both for the patient and the system as a whole; and impoverished patients... are not helped by complex requirements for extended coverage."

Deacon William Grimes, who runs the New Hope Clinic in Bath County, one of the state's poorer counties, said many of his patients have no income and don't have enough money to pay for a $4 generic prescription.

"If they can't pay a $4 generic, how are they going to pay a co-pay, how are they going to pay premiums, how are they going to pay for anything?" he asked. "Yes, there are some people who this 'skin in the game' might help, but the people I deal with can't afford it."

Read More

Law and Order? - Bristol-Myers-Squibb Settles Case Alleging Fraud and Kickbacks, No Admissions of Guilt, No Individuals Charged

Introduction 

Donald Trump, Republican candidate for the US presidency last week announced he is the "law and order" candidate, accompanied by then vice presidential contender and New Jersey Governor Chris Christie.



I wonder if all this interest in law and order will lead to increasing the effectiveness of enforcing laws when large US health care corporations are accused?

For years, we have been watching a parade of legal settlements made by big US health care organizations.  These have included the biggest drug companies, biotechnology companies, device companies, insurance companies, etc, etc.  Many involved accusations of fraud, kickbacks, and other seeming crimes.

In many cases, the alleged white collar crimes could have resulted in harms to patients.  For example giving physicians kickbacks to promote particular drugs or devices could have led them to prescribe treatments that could have been useless for particular patients, yet subjected those patients to risks of adverse effects.

Yet few of these cases were resolved with findings of guilt.  Many resulted in financial penalties for the accused organization, but which were tiny compared to that organization's revenue.  Almost none resulted in any consequences for the people in the organization who might have individually profited from the alleged actions, particularly the top executives who were making millions of bonuses, suggesting their apparent impunity.

This parade of settlements does not look like instantiation of law and order to me, in my humble opinion.

Bristol-Myers-Squibb Settles Allegations of Kickbacks

And the parade continues.  The latest case, which barely was noticed in the media, involved huge pharmaceutical company Bristol-Myers-Squibb.  It was best documented by Ed Silverman in Stat,

After nearly a decade of litigation, Bristol-Myers Squibb on Monday agreed to pay $30 million to settle charges by California officials of paying kickbacks to induce doctors to prescribe several of its medicines.

The settlement with the California Department of Insurance stemmed from a whistleblower lawsuit that was filed in 2007 by three former Bristol-Myers employees. They alleged that from 1997 through 2003, the drug maker used a wide variety of inducements to generate revenue. The state later joined the lawsuit in 2011 and, last year, the former employees were dismissed from the case by a state court.

The kickbacks included box seats at sporting events where doctors were given food, drinks, and parking; enrollment in a Los Angeles Lakers basketball camp for doctors and their children; prepaid golf outings at luxury courses; tickets for doctors and their families to see Broadway shows in California cities; and lavish dinners, resort hotel trips, and concert tickets for doctors who were especially big prescribers.

Among the many medicines for which doctors were persuaded to write more prescriptions were the Pravachol cholesterol pill; the Plavix blood thinner; the Abilify antipsychotic; the Glucophage diabetes treatment; and the BuSpar antianxiety drug.

A Bristol-Myers spokesman wrote us that the company denied any wrongdoing, but also noted that the firm began adhering to a voluntary industry marketing code in 2002. 'We are pleased to put this matter behind us so that we can focus on making transformational medicines for patients battling serious diseases,' he wrote.

Note that in this case, as is typical for such cases, the financial penalty seems to be minimal compared to the company's total revenues (more than $16.5 billion according to Google finance.)  The company was allowed to deny wrongdoing (although in absence of same, why should it pay a fine?)  No individuals who might have personally profited from the actions in question suffered any negative consequences.

Why Not More Severe Penalties for a Repeat Offender?

Furthermore, the outcome seems to have nothing to do with the accused's track record.  Anyone who follows the news knows that in general, penalties in criminal cases are likely to be different for first offenders and habitual criminals.  Penalties in civil cases also may depend on the defendant's track record.

However, this case, like most other cases involving big health care organizations, seems to have occurred in a vacuum, separate from the company's track record.  Yet a bit of searching reveals that BMS, like many other big health care corporations, seems to have a pretty bad record.


- In 2003, for $617 million, BMS settled suits alleging it tried to prevent competition from low cost generic versions of its products Taxol and Buspar (per the NY Times).
- In 2004, for $150 million, BMS settled suits by the SEC alleging accounting fraud (per the NY Times here).
- In 2007, BMS paid a $1 million dollar penalty while pleading guilty to lying to federal agents about a deal with the Canadian drug company Apotex (per Law360).   In 2009, it paid additional financial penalties in response to a US Federal Trade Commission charge about this case (per the FTC).
 - In 2007, for $515 million, BMS settled a suit alleging it used kickbacks to induce use of Abilify for dementia and by childeren, despite evidence that the drug was not suitable for either.  The settlement included a five year corporate integrity agreement.  (Look at our post here).
 - In 2014, BMS settled allegations its subsidiary Lantheus Medical Imaging Inc evaded state taxes (per the Corporate Crime Reporter)
 - In 2015, Bristol-Myers-Squibb settled allegations by the US Securities and Exchange Commission (SEC) that it bribed physicians in China to induce them to prescribe its drugs.  (Look at our post here).

(Parenthetically, I apologize that many of these previous cases have not been previously mentioned on Health Care Renewal.  For that I apologize.  Yet some simple Google searches were all that were required to find them.)

Why did none of the law enforcers involved in the later cases do similar searches, and why did the company's track record not figure into how the current case was resolved?

Chris Christie and the Rise of the Deferred Prosecution or Corporate Integrity Agreement for Too Big to Jail Organizations

The answer to that will not be easy.  At best, it now seems to be standard operating procedure for law enforcement to treat big health care organizations very gently.  However, there is one clue in BMS track record that it might be helpful to discuss in this political season.


Note that in one of the biggest settlements listed above, BMS agreed to a corporate integrity agreement.  According to a 2015 article in Time, the use of such agreements, coupled with apparently large fines but no other penalties, for corporate offenders was pioneered by none other than then US Attorney Chris Christie, (who spoke in the video above).

Christie was apparently horrifed by the criminal prosecution of Arthur Andersen, a big accounting firm, in the wake of the Enron scandal.  At that time, federal prosecutors acted so that

The company itself—not its employees who might have been responsible—was indicted and found guilty. The trial put the company out of business. The conviction was overturned on appeal, but not before the company’s reputation was destroyed and its employees forever branded with a Scarlet Letter, representing Andersen, not Adultery.

The article described Mr Christie's response:

Christie had watched wall-to-wall coverage of the case, and it made him uncomfortable. He decided he did not want to run his office in that way. Instead of bulldozing New Jersey companies facing smaller-scale fraud cases and leaving their employees out of work, Christie preferred to build a case against the firms and then bring their leaders in for a take-it-or-leave-it chat. Ultimately, seven New Jersey corporations accepted deferred prosecution agreements, or deals with the government that let them avoid trial in exchange for the companies hiring independent monitors to oversee operations and put in place guards against future wrongdoing.

Christie often was relieved they were open to the deals. 'Put the company itself out of business? Lose all the jobs?' Christie asked when asked about the alternatives. He pointed to a corruption case he built against St. Barnabas Health Care System, the state’s largest, for double- and over-billing Medicare and Medicaid services. St. Barnabas paid $265 million to settle the case. 'What are you going to do?' Christie asks. 'Close the hospital, the largest hospital that serves the poor?'

Neither Time, nor Mr Christie seemed to notice that this reasoning involved a logical fallacy, a false dilemma.  True, there are two options:
1) criminally prosecute the whole company
2) allow the company to operate under a deferred prosecution or corporate integrity agreement.
But there is a third option:
3) Criminally prosecute the individuals in the company who were most involved in and most benefited from the bad behavior.

So in the St Barnabas example, what he could have done was prosecute the people at St Barnabas who were most responsible for the over-billing, and let the hospital itself go with a fine. Mr Christie for some reason never seemed to think about that option.  Neither have most other US law enforcers who have dealt with large organizations since.

Ironically, Mr Christie has got himself into some ethical hot water because of how he managed corporate integrity or deferred prosecution agreements involving BMS and other health care organizations.  Some have alleged that Mr Christie found some other advantages to using such agreements, advantages that accrued mainly to Mr Christie and his cronies.  As the Time article noted, re BMS

As part of its penance, the company also proposed paying for a professor of business ethics at a law school. The company initially offered to pick up the tab at a school in New York. No way, Christie said. 'This is a New Jersey case. Pick a New Jersey school,' Christie replied. Rutgers already had such a program, and there was only one other law school in New Jersey. It just happened to be Christie’s alma mater, Seton Hall. 'It couldn’t have mattered less to me,' Christie says. 'I didn’t get anything out of it. I was long graduated from Seton Hall.' (The Justice Department signed off on the agreement, but would later limit U.S. Attorneys’ ability to negotiate such deals.)

Christie’s critics pounced on the $5 million payment to Seton Hall, and to this day are trying to use it as a way to suggest he is another pay-to-play New Jersey politician.

And in two other health care cases:

Christie hired former Attorney General John Ashcroft, his one-time boss, to monitor Zimmer Inc., one of the firms that settled with the government. In turn, Ashcroft’s company charged between $1.5 million and $2.9 million a month to monitor the medical device company. By the time Christie arrived in Washington to answer lawmakers’ questions, The Ashcroft Group had earned $52 million on that case. 'To me, that is outrageous,' Rep. Steve Cohen chided Christie. 'I don’t care what you did. It is not worth $52 million,' the Tennessee Democrat continued. 'Even if you took steroids and hit 70 home runs, it is not worth $52 million.'

Lawmakers also wanted to know why he named David Kelley to a post to oversee the Bristol-Myers Squibb settlement. Kelley two years earlier, as a former prosecutor, declined to bring securities fraud charges against Todd Christie, the future-Governor’s brother. Was this payback for sparing a Christie Family?

Mr Christie defended his conduct in the BMS case:

Christie to this day says he has no regrets about the deferred prosecution agreements, including the professor position. To him, it matters less about whether there was a conviction than whether the illegal behavior ended. 'The goal as the U.S. Attorney is to stop the conduct,' Christie says. 'If you’ve stopped the conduct, you’ve won.'

But of course the current case, and those involving BMS from 2014 and 2015, shows that Mr Christie's corporate integrity agreement did not "stop the conduct" at least in the case of BMS.  That rationale was fallacious too.


Summary

Now that political campaigners are once again shouting about law and order, maybe this is the time to call for effective and equal enforcement of the laws regarding white collar crime in health care.  For years, we have watched perpetrators of small scale Medicaid and Medicare fraud go to jail.  Yet when big companies are accused of big scale crime, almost no one ever goes to jail.

It is time for equal justice for all in health care.

Let me end with a quote from a report by Senator Elizabeth Warren (D - Massachusetts) published in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy."

 Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims—all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies – and particularly the Department of Justice (DOJ) – rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

And end with a video of her speaking on the subject.

Read More

Foundation for a Healthy Kentucky has many concerns about new Medicaid plan; health officials say current plan is not sustainable

By Melissa Patrick
Kentucky Health News

FRANKFORT -- At a legislative committee meeting July 20, health advocates urged the administration of Gov. Matt Bevin to make sure the final plan is evidence-based and that they fully understand the people it will affect. Administration officials said changes are needed because the 2014 expansion of the program isn't sustainable.

"We are asking, as in any well-designed program, that it starts with an awareness of who are these people we are trying to help, what jobs are available in their communities, what is their education level, are they already working two or three jobs, or not able to find a job, do they have access to a computer?" said Susan Zepeda, president and CEO of the Foundation for a Healthy Kentucky.

Bevin's plan calls for participants to pay premiums and have a higher level of involvement in their care, including community engagement and work requirements for able-bodied adults who aren't primary caregivers or dependents -- requirements that Bevin calls "skin in the game," but health advocates call "barriers to care."

"Kentuckians who don't have paid sick leave, reliable transportation or a bank account already face greater barriers to obtaining and keeping insurance coverage and participating in their own health improvement. Their lost wages and time investment are their 'skin in the game'," Zepeda said in a news release. "A Medicaid reform plan that creates more barriers will exacerbate the state's already challenging health statistics and health disparities."

In her testimony, Zepeda praised several aspects of the waiver proposal, including the expansion of substance abuse treatment services, sustaining the behavioral health services in the state, managed care organization reforms and its healthy behavior incentives.

But she also came with a long list of concerns, such as the loss of dental and vision benefits from the core benefit package, denial of services and monetary penalties for nonpayment of premiums, the work requirements, the loss of non-emergency transportation to and from medical appointments, the reduction in smoking-cessation options, and the premiums for all income levels.

Despite provisions for regaining coverage after nonpayment, Zepeda said, "In some ways we liken this to taking a hungry child with a bad tooth ache who is misbehving in school, can't pay attention and kicking that child out of school and then wondering why he or she isn't learning."

Republican Rep. Addia Wuchner of Florence said she supported the requirements for able-bodied Kentuckians to have to earn their dental and vision benefits because it will "help them to be an engaged health-care consumer."

But Zepeda said poor people struggle to save money, especially when they don't make enough to buy groceries or pay the rent. She said many in this population work, and wouldn't have time to peform extra tasks to get dental or vision services.

Wuchner also supported the work and volunteer requirements. "If this would incentivize that individual to take the extra step to gain more education so that there are other jobs available to them, I just say that that is an incentive, not a disincentive," she said.

Gabriela Alcalde, vice president of policy and programming at the foundation, said research does not support the effectiveness of work requirements for the poor. While voluntary skills and education training have been found to have very positive outcomes, mandatory work requirements do not have lasting effects, she said, so once people get out of the program, the effects disappear.

"They also increase poverty in some cases and do not in any way eliminate the barriers to access," Alcalde said. "So we actually have people lose coverage, but not maintain gains with certain strategies."

Zepeda said Bevin's request to the federal government, for a waiver of normal Medicaid rules, would better seek such things as price transparency, which would allow participants to price-shop for their health care; integration of behavioral health, oral health and primary care under one roof; or to deliver care where people are, like schools.

"There are lots and lots of opportunities for care delivery reform that will lift up Kentuckians, make the access to care more equitable and help the state prosper," she said.

Sen. Danny Carroll, R-Paducah, who earlier in the meeting said that the requirement for individuals to be on their employee based health plan if possible would likely add a financial burden to small businesses, summed it up.

"If you have to choose between some requirements and ownership or not being able to serve that population at all, I think it is clear that we have to require the ownership and some input and some investment from these folks to keep the system going," he said. "I think it is a good balance on what we are trying to do without totally doing away with expanded services, but being able to afford it as a state."

Administration defends plan

Medicaid Commissioner Steve Miller said that almost 500,000 people have been added to the Medicaid rolls through the expansion, which allows those with incomes to 138 percent of the federal poverty line to get Medicaid, with no long-term plan to pay for them.

"One of the concerns from the very beginning has been the sustainability of Medicaid expansion as we know it today," he said, noting that the cost to the state between 2017 and 2021 will be $1.2 billion. The federal government pays for the expansion through this year, but next year the state will be responsible for 5 percent, rising in annual steps to the reform law's limit of 10 percent in 2020.

The Steve Beshear administration said the expansion would pay for itself by creating health-care jobs and tax revenue, but the Bevin administration has said that hasn't happened. No one has offered definitive figures.

"The funding will just not be available," Miller averred. He said Medicaid's budget has been increased by approximately $600 million over the next two years, while the consensus revenue projection is that new revenue coming into the state during the same time frame will be $585 million.

"Medicaid consumes every new dollar of revenue that comes into the state over the next two years," without change, Miller said, and that will continue in the following budgets. That means that paying for Medicaid will crowd out all other initiatives, like pension funds, education, and corrections, he added.

The administration estimates that the waiver would reduce total Medicaid spending over five years by $2.2 billion dollars, but only $331 million of that would be state money, as a result of lower enrollment and less use of the program.

Adam Meier, Bevin's deputy chief of staff, said the new plan's goals are to improve participants' health, to instill personal responsibility, to move people into commercial health insurance plans, to empower people to seek employment and to achieve fiscal sustainability.

Read More

Study finds no link between tighter controls on prescription opioids and increased use of heroin; some researchers disagree

National overdose-death rates for heroin (red) and prescription opioids (blue)

By Al Cross
Kentucky Health News

Soon after Kentucky cracked down on "pill mills" where prescription painkillers were easily available, officials noticed a jump in heroin arrests and overdoses, and many presumed that one helped lead to the other. A study published in the New England Journal of Medicine found no link between the two, at least on a national scale, but some other experts disagree.

The study was conducted by physician William Compton of the National Institute on Drug Abuse, pharmacy Dr. Christopher Jones of the Department for Health and Human Services and public-health specialist Grant Baldwin of the federal Centers for Disease Control and Prevention.

They wrote, "It appears that the shift toward heroin use among some non-medical users of prescription opioids was occurring before the recent policy focus on prescription-opioid abuse took hold." They note that heroin use began to increase by 2007, and that a pill-mill crackdown in Florida, similar to Kentucky's, was followed by only a small increase in heroin overdoses.

"The results of these studies consistently suggest that the transition to heroin use was occurring before most of these policies were enacted, and such policies do not appear to have directly led to the overall increases in the rates of heroin use," the researchers wrote. "Although the majority of current heroin users report having used prescription opioids non-medically before they initiated heroin use, heroin use among people who use prescription opioids for non-medical reasons is rare, and the transition to heroin use appears to occur at a low rate."

They said the shift from prescription opioids to heroin is most prevalent among "persons with frequent non-medical use and those with prescription opioid abuse or dependence," and is driven mainly by cheaper, purer and more accessible heroin.

Those conclusions drew a letter to the journal from researchers who have concluded otherwise. Theodore Cicero and Matthew Ellis of the Washington University School of Medicine in St. Louis wrote, "A growing body of research has shown direct associations between the introduction of reformulated OxyContin and increases in rates of heroin use." The reformulated drug was much harder to inject; the federal researchers looked at the possible effect of the change and discounted it.

The critics didn't mention state crackdowns, but wrote, "It would be unwise for the agencies that the authors represent to ignore unanticipated negative aspects of efforts to limit supply, such as a shift to heroin in some persons, even if they represent a small part of the total heroin problem."

The federal researchers concluded their report with lines few could disagree with: "Fundamentally, prescription opioids and heroin are each elements of a larger epidemic of opioid-related disorders and death. Viewing them from a unified perspective is essential to improving public health. The perniciousness of this epidemic requires a multi-pronged interventional approach that engages all sectors of society."

"The last sentence is the most important," said Van Ingram, director of the Kentucky Office of Drug Control Policy. "Prescribing regulations are more about slowing the creation of new people obtaining an opioid-use disorder. If we keep prescribing at the same rates this country has been this problem never gets solved."

Read More

Young diabetes coalition coordinator forms partnerships to uncover and fight the disease in five Eastern Kentucky counties

By Mallory Powell
University of Kentucky

Growing up in Hazard, Brittany Martin was familiar with diabetes. Many of her older relatives had been diagnosed with the chronic condition, and her younger family members were starting to develop it as well. In a state with one of the highest rates of diabetes — 11.3 percent of adults had a diagnosis in 2014 —Martin’s family wasn’t out of the ordinary, but she found the status quo unacceptable.

Since she graduated from the University of Kentucky in 2014 with a dual degree in biology and sociology, Martin’s family history and her interest in health have converged in her current role as coordinator of the Big Sandy Diabetes Coalition, where she serves as an AmeriCorps Vista volunteer.

Brittany Martin administers a diabetes screening. (UK photo)

The coalition, based at Big Sandy Health Care in Prestonsburg, aims to improve detection, prevention and treatment of diabetes through screening and connection with local resources; it serves Floyd, Johnson, Magoffin, Martin and Pike counties, the Big Sandy Area Development District.

Diabetes is especially prevalent in the region, with 13 percent of adults diagnosed with it. In Pike County, the rate is at least 16 percent.

The rates are based on surveys that ask people if they have been diagnosed with the disease. An estimated 138,000 Kentuckians are thought to be living with undiagnosed diabetes.

As diabetes coalition coordinator, Martin juggles many responsibilities, from hosting community screenings to planning board meetings and writing a regular newsletter. It didn’t take her long to observe that irregular screenings, a lack of follow-up, and shortage of robust data inhibited diabetes prevention and care at both individual and community levels.

“We decided we wanted to set up more systematic screenings, instead of opportunistic screenings, and eventually set up a diabetes registry and keep track of participants,” Martin said.

She is now leading a project to determine whether regular community screenings and targeted follow-up can help to identify undiagnosed cases, measurably improve health, and reduce the emotional and economic burden of diabetes through connection with local resources.

"Brittany’s important work, receptivity to our input, and unparalleled enthusiasm have made her a stellar CLIK participant," said Nancy Schoenberg, co-director of community engagement and research for the CCTS. "She is an ambassador for UK, the CCTS and CLIK, sharing her expertise and her commitment to the health of residents of the commonwealth."

Martin, a registered phlebotomist, has personally screened 586 people since she began working with the coalition in August 2015. At each initial screening, she gathers baseline data and provides diabetes education. She then follows up with people who are diabetic or pre-diabetic to connect them with local resources and encourage them to come back for screening in six months.

Much of Martin's work has been supported by grants and training from the University of Kentucky Center for Clinical and Translational Science, which facilitates interdisciplinary and community-engaged health research with a focus on Appalachia. A CCTS community engagement grant provided funding for a pilot study of diabetes screening at a senior living center in Pike County.

Martin, 25, has since received further funding and research training through the CCTS Community Leadership Institute of Kentucky, which aims to enhance the capacity of local leaders to address health challenges.

Through CLIK, Martin received training on evidence-based interventions, data mining for research, and data collection and analysis — essential skills to assess the impact of a project. Equipped with this additional expertise, she is now researching the effectiveness of her diabetes screening system in Martin County.

The opportunity to work in several Appalachian counties, especially Kentucky's two easternmost, has enlightened even a native of the region about its diverse needs and challenges.

“People speak of Appalachia as a whole, but Martin County has so much less than Pike County,” she said. “Martin County doesn’t have a hospital. They have such a lack of access to care. They have one grocery store. It was very hard for me to find the resources to give them.”

Depending on the month, Martin hosts up to 10 community screenings across the five counties served by Big Sandy Health Care.

The results alarm her. “It’s actually kind of scary. Roughly 24 percent of people are pre-diabetic and 25 percent are diabetic. That’s roughly half of my sample in the red zone,” she said.

Martin sees particular challenges for individuals who face multiple health issues and dire socioeconomic circumstances. “Sometimes we’ll go do screenings in the homeless shelter. Imagine being homeless and diabetic. Sometimes people are also recovering from addiction. Really, can you imagine being homeless and diabetic and recovering from an addiction?”

At some of the community screenings, people have been surprised to learn that they’re diabetic or at immediate risk. In a screening at Big Sandy Community and Technical College, she said, many students “learned that they had pre-diabetes, and they were in their early 20s. It was scary for them. One person was diabetic and didn’t know it. At all ages we’ve screened, there’s been at least one person who’s said ‘Oh my god, I didn’t know, I didn’t know the signs.’”

However, the data she has gathered encourages her about the potential impact of systematic community screening with targeted follow-up.

Her initial screening study in Pike County found that 50 percent of people who received follow-up information and returned for their six-month screening had lower A1C levels, the essential measurement for a diagnosis of diabetes.

Martin's demonstrated success has also yielded nearly $20,000 in outside funding to pay for community screenings and upcoming educational classes. The Anthem, Aetna and Passport health plans have provided a total of $11,000 in sponsorships for screenings. It costs about $7 to screen one person.

Martin also recently received a $9,000 grant from Marshall University in West Virginia to support diabetes education classes in Big Sandy communities, with “gentle yoga” exercises for their clients in order to increase movement and activity, especially for individuals who are wheelchair-bound or have trouble exercising.

“There are a lot of positive health effects of gentle yoga,” she said. “We work with the aging population, and as they age we want to keep them moving. Safe, slow movements, even if someone is wheelchair-bound, can help keep away chronic effects of things like diabetes.”

Martin is developing yet another partnership to integrate retinopathy eye screenings at some community-outreach events. Over the course of nearly 600 diabetes screenings, Martin observed the a great need for eye care, and engaged both UK and the new Kentucky College of Optometry at the University of Pikeville to provide retinopathy screenings at some of her events.

When Martin isn’t busy with her full-time (and mostly unpaid) work as the diabetes coalition coordinator, she works at least 30 hours a week as a waitress. She is also studying for the Medical College Admission Test and the Optometry Admission Test, with plans to apply to medical and/or optometry school at Pikeville. Her ultimate goal is to become a practicing physician in a rural community.

She has a demanding portfolio of responsibilities, and says she sleeps about five hours a night but doesn’t tire of her work: “I’m right where I’m supposed to be.”

Read More

Ky. leads nation in cancers that are caused by a virus for which there is a vaccination, but most kids don't get the vaccinations

By Melissa Patrick
Kentucky Health News

Kentucky has the highest overall rate of cancers associated with the human papillomavirus, and among females is tied for highest with West Virginia, while at the same time falling in the bottom 10 states for vaccinations that can keep the virus from causing cancers, according to a federal Centers for Disease Control and Prevention report.

"Kentucky faces many challenges when it comes to encouraging parents, adolescents and providers to understand the importance of the HPV vaccine," Dr. Ardis Hoven, infectious-disease specialist for the  state Department for Public Health, said in an e-mail to Kentucky Health News.

Speakers at a recent HPV conference in Lexington placed most of the blame for the poor uptick of HPV vaccinations on physicians, because many of them still don't strongly recommend it. They cited a study showing that a "clear, same-day recommendation" from a physician to a parent is the most important factor in whether children get vaccinated.

The speakers offered several reasons for the lack of such recommendations: The vaccination isn't required by law, many physicians don't realize its importance, some falsely believe that it takes too much time to explain, and the vaccine treats diseases that pediatricians don't deal with. They also noted that the vaccine's greatest obstacle is that it is associated with a sexually transmitted disease.

“In order to increase HPV vaccination rates, we must change the perception of the HPV vaccine from something that prevents a sexually transmitted disease to a vaccine that prevents cancer,” Electra Paskett, co-director of the Cancer Control Research Program at the Ohio State University Comprehensive Cancer Center in Columbus, told HealthDay News. “Every parent should ask the question: If there was a vaccine I could give my child that would prevent them from developing six different cancers, would I give it to them? The answer would be a resounding yes—and we would have a dramatic decrease in HPV-related cancers across the globe,”

HPV is most commonly transmitted through sexual intercourse, but it can also be transmitted through any skin-to-skin contact.

The three-dose HPV vaccine was approved by the federal government 10 years ago and is recommended for 11- and 12-year-old boys and girls, though it can be given through age 26 for females and age 21 for males. It is recommended at an early age because adolescents have the best immune response to the vaccine, are more likely to keep coming in for annual visits and most are not yet sexually active and therefore not likely to have been exposed to the virus.

HPV infections cause more than 90 percent of anal and cervical cancers and 70 percent of vaginal, vulvar, penile and middle throat cancers, and two of the HPV strains are associated with more than 90 percent of anal and genital warts.

The CDC report found that there were almost 39,000 annual cases of HPV-related cancers in the country between 2008-12, a 16 percent increase from the previous five year period. Most of these cases were oral cancers in men and cervical cancers in women, 12.638 and 11,771 respectively.

The data showed that almost 80 percent of the cancers were caused by two strains of the virus that are covered by all of the commercially available vaccines and 10 percent were caused by five other HPV strains that are covered by the newer nine-valent vaccine.

In Kentucky, only 37.5 percent of its girls and 13.2 percent of its boys aged 13 to 17 were vaccinated as of 2014. Nationwide, fewer than half of girls and only one-fifth of boys are getting immunized, and vaccination coverage did not increase substantially from 2011 to 2014.

Hoven said that Kentucky is working to improve its HPV vaccination rates. She noted such efforts as its HPV initiative team, which has created a comprehensive statewide plan to prevent and control HPV infections; a statewide media campaign last summer to encourage parents to get their children vaccinated; ongoing outreach to universities and colleges about the need to immunize students; and a current survey of knowledge among teens and adults about the importance of HPV vaccinations.

The state health department "has taken up the challenge of improving vaccination rates in the state, and will continue this effort going forward," Hoven said.

Read More

Kentucky's 40% surcharge for smokers on Obamacare plans probably scared some away, hasn't encouraged them to quit

Allowing insurers to charge smokers extra for Obamacare health insurance appears to have discouraged them from getting it, "undercutting a major goal of the law," Carolyn Y. Johnson reports for The Washington Post. "The surcharges, of up to 50 percent over nonsmokers' premiums, also showed no sign of encouraging people to quit." That's according to a study at the Yale School of Public Health, published in Health Affairs.

"To explain how the surcharge works, Friedman and colleagues provided this example: Take the case of a 49-year-old with an income at 150 percent of the poverty level. If that person were a nonsmoker, he would pay only $60 per month for a particular health plan, because the tax credit would pay the rest," Johnson writes. "But the premium surcharges that smokers face are not eligible for tax credits. So a smoker would — based on an analysis of 43 states that allowed surcharges in 2014 — pay a median $70 surcharge on top of that premium, doubling their out-of-pocket costs of insurance."

26.5 percent of Kentuckians smoke, second only to West Virginia.

Kentucky was one of those states, allowing surcharges of up to 40 percent. It has the nation's second-highest smoking rate, 26.5 percent.

The researchers found that in 2014, the number of U.S. smokers with insurance rose to 76 percent, from 70 percent in 2013, but "estimated that if the surcharges did not exist, that number would have risen to 80 percent," Johnson reports. "The effects were especially noticeable for smokers under 40 years old. In 2014, 65 percent of the smokers in the sample had health insurance, but 75 percent would have enrolled if the surcharges were eliminated, the researchers estimated."

Scaring away younger smokers backfired. "Younger smokers tend to have health-care costs similar to other young nonsmokers, so their participation in the marketplaces helps balance the risk and makes insurance work," Johnson notes. "Second, stopping smoking when people are younger can have big, long-term health benefits for individuals and in helping to prevent costly chronic conditions."

A spokeswoman for the Centers for Medicare and Medicaid Services noted that before the health-reform law, insurance companies could refuse to cover smokers. And the law required insurance plans to pay for smoking-cessation programs and medications.

The authors of the study said states could reduce or eliminate the surcharges, or (and this would be harder to administer) eliminate them for people who enroll in smoking-cessation programs. "A separate concern that Friedman raised was that the rules could lead people to lie about whether they smoke, to avoid the surcharge," Johnson reports. "If that also led to patients lying to their doctors, it could have real public-health consequences."

Read More