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."

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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.)

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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.

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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.

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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.

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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.

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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.

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