Remarks by President Trump to Members of the Coast Guard | Palm Beach, Florida---White House press release issued 11/ 23/ 17
https://www.whitehouse.gov/the-press-office/2017/11/23/remarks-president-trump-members-coast-guard-palm-beach-floridaTHE PRESIDENT: It is an honor to be here, I have to tell you. You know, the Coast Guard, always respected. But if you were looking at it as a brand, there’s no brand that went up more than the Coast Guard, with what happened in Texas. And I would say, in particular, Texas has been incredible. You saved 16,000 lives -- nobody knows that -- 16,000 lives.
In fact, when I first heard the number, I said, you mean like, six hundred? Five hundred? Sixteen thousand lives in Texas. So, as bad as that hurricane was -- and that was a bad one. That was a big water job, right? It kept coming in and going back. They couldn’t get rid of it. They’ve never seen -- I guess it was the biggest water dump they’ve ever seen. But when you get 16,000 -- good to see this group of people. But when you do 16,000, that’s really something.
And then Florida hit, and you know that one very well. You knew that one pretty well, right? The job you did in Florida. And then, Puerto Rico.
And I really mean that. I think that there is no brand, of any kind -- I’m not just talking about a military brand -- that has gone up more than the Coast Guard. Incredible people. You’ve done an incredible job. And I love coming in here and doing this with you today. I think it’s -- well, we have to keep you very well fed. This is good stuff. But it’s an honor.
And the First Lady, you know --
MRS. TRUMP: Happy Thanksgiving.
AUDIENCE: Happy Thanksgiving.
THE PRESIDENT: And we went together to Texas, and we saw what you were doing. And you just followed that storm, right next to that storm. And you just -- you saved so many people.
I still haven’t figured out how people take their boats out into a hurricane. Someday you’ll explain it. Gene was just telling me that they actually do it to save their boat, in many cases. But they’re not thinking about their life, they’re thinking about their boats. And, I don’t know -- I mean, they go out in a boat and they think, I guess, they’re -- you know, they’ve got a wonderful boat, they’ve had it for years, it can weather anything. And then they have 25-foot waves pushing out -- and that would be the end of them.
So you saved a lot of people. And I just want to thank you on behalf of the whole country and on behalf of us. What a job you’ve done, and thank you all very much. And I’ll also take questions if you have them.
Now, should we leave the media here to do the questions? Or should we tell them to leave? You know what, it’s Thanksgiving, so let’s let the media stay. Okay?
Anybody have any questions about the country, how we’re doing, or any of those things? I love it when you don't. (Laughter.) See, that means you're doing great. I love that. That's the greatest.
The press, I know, doesn't have any questions. If you do, we won't take them, but that's all right. The press has plenty of questions.
But the country is doing really well. Stock market, all-time high. This is all good stuff. I just spoke to a lot of your friends in Afghanistan and in Iraq. We spoke to the USS Monterey -- great ship, great missile ship. We spoke to a lot of different folks from the Air Force, the Army -- just now, a little while ago at Mar-a-Lago.
The telecommunications systems, what you can do now, we go live to Iraq, live to Afghanistan. I mean, it’s really incredible. But I told them our country is doing great. And you folks are fighting so hard and working so hard. And it’s nice that you’re working for something that’s really starting to work.
We’ve cut back so much on regulation and all the waste, and all the abuse. And the stock market on Friday hit an all-time high. The highest it’s ever been, ever.
Your whole, long life, the stock market is higher than it’s ever been. And that means your 401(k), all of the things that you have, whether it’s -- even if you’re in the military, you have a country that’s really starting to turn.
We want to have a strong country. We want to have a country where I can buy new Coast Guard cutters and not have to worry about it, all right? And that’s what we’re doing, we’re building up wealth so that we can take care of our protection. And we’re ordering tremendous amounts of new equipment. We’re at $700 billion for the military. And, you know, they were cutting back for years. They just kept cutting, cutting, cutting the military. And you got lean, to put it nicely. It was depleted, was the word. And now it’s changing.
The Navy, I can tell you, we're ordering ships. With the Air Force, we're ordering a lot of planes, in particular the F-35 fighter jet, which is, you know, almost like an invisible fighter. I was asking the Air Force guys, I said, how good is this plane? They said, well, sir, you can't see it. I said, yeah, but in a fight -- you know, a fight -- like I watch in the movies -- they fight, they're fighting. How good is this? They say, well, it wins every time because the enemy cannot see it. Even if it's right next to it, it can't see it. I said, that helps. That's a good thing.
But, I mean, we have equipment that -- nobody has the equipment that we have. And it's sad when we're selling our equipment to other countries but we're not buying it ourselves, okay? But now that's all changed. And the stuff I said -- the stuff that we have is always a little bit better too. You know, when we sell to other countries, even if they're allies -- you never know about an ally. An ally can turn. You understand. You're going to find that out. But I always say, make ours a little bit better. You know, give it that extra speed. A little bit -- keep a little bit -- keep about 10 percent in the bag, because what we have -- nobody has like what we have, and that's what we're doing.
But we're really proud of the Coast Guard. And I'm very proud -- I walked in today and Gene said, the day I got elected, the following morning they were putting up the statement that I made right on your front door -- right on your glass. And I came in and the first thing I noticed, of course -- I said, wow, look at that. And I said, did you put that up just for me because I happened to be coming here today? And you did that the first day, so that tells me something. That tells me something. Thank you. Special guys.
Let's go, fellas, come on. Let's get up here. Let's get up here.
(PAGE 2) From our Governor, Jay Inslee
How can Washington offer more career options to students? Part of the answer can be found in Switzerland--from the Governor's blog (dated 11/ 20/ 17)https://medium.com/wagovernor/how-can-washington-offer-more-career-options-to-students-8a9c3cb4445e
“We have to stop telling our kids that a four-year degree is the only way to start their paths to success. Most of them will require education and training after high school, but that doesn’t necessarily mean they have to start with a four-year college degree.”
Those were Gov. Jay Inslee’s words in May when he launched his Career Connect Washington initiative and announced his goal of connecting 100,000 students to career-connected learning opportunities in the next five years.
And that goal is what inspired a high-level delegation of leaders traveling to Switzerland this month for an immersive four-day study mission to learn about the country’s widely lauded apprenticeship system.
Approximately 45 delegates representing business, labor, education, philanthropy and government organizations learned how the country has created an ecosystem in which business, government, and education come together as partners to create apprenticeship pathways to diverse careers. Approximately 70 percent of young people choose apprenticeships instead of traditional high school.
The delegation visited leading Swiss businesses, apprentice training centers, career counseling centers and the country’s top university to meet with apprentices, educators, parents, researchers, government officials and business leaders.
“In Switzerland, the system is designed for everyone and there is no stigma,” said Suzi LeVine, former U.S. Ambassador to Switzerland and Liechtenstein, and a delegation co-chair along with her husband, Eric LeVine. “What Eric and I saw during my time as ambassador and what our delegation saw during our visit, is that apprenticeship is the ultimate in project-based learning and is the best delivery vehicle for 21st century skills.”
Swiss businesses are creators, not just consumers of talent. They pay for about 60 percent of the costs of the country’s apprenticeship program and most see a 7–10 percent return within three to four years, according to professor Stefan Wolter, director of the Swiss Coordination Center for Research in Education, who presented his research to the delegation on their first night in Bern.
The notion that shared investment in apprenticeship is beneficial to business was reinforced multiple times as the delegation met with business leaders from various sectors including advanced manufacturing, health care, telecommunications, and information and communications technology. Businesses in many sectors come together in associations to develop the competencies and curriculum they think is most necessary for their respective professions. To keep pace with innovation, businesses work together to update the standards every five years.
Arthur Glattli, managing director for the manufacturer’s association, Swissmem, told delegates: “When you do it all together, it’s a win-win situation. It levers up the system. Workers learn from each other. It’s not a cost, it’s an investment.”
Volker Stephan, a senior human resources official for ABB, said apprenticeship is a key strategy to building a workforce that can adapt to changing needs. “There are basic skills people need to know, however we need people who can think more widely and learn to be solution-providers.”
For ABB, this philosophy isn’t just a talking point. The company helped launch libs, an intermediary organization that trains the apprentices for their first two years. Libs focuses on advanced manufacturing, IT and commercial jobs and partners with 90 businesses.
In Switzerland, getting into certain apprenticeships can be just as competitive as university admission. At Swisscom, the nation’s leading telecommunications provider, only a few hundred apprentices are hired each year out of thousands of applications. At ETH Zurich, it is more competitive to become an apprentice in their physics department than it is to become a student.
And apprentices often work their way to highly successful and executive level positions. ABB’s chairman, Peter Voser, started as an apprentice, as did Ingo Fritsche, the CEO of libs.
Washington state has some successful paid youth apprenticeship programs underway such as AJAC. But Inslee hopes delegates have been inspired to become part of his effort to create a comprehensive system with business leading. Several of the delegates are also part of Inslee’s Career Connect Washington task force, which will deliver a report early in January outlining recommended next steps.
“Not everything about the Swiss system is right for Washington, but if there’s one thing we learned it’s how absolutely necessary it is for this to be a true collaboration and partnership between business, government and education,” Inslee said. “Both our residents and our businesses can benefit from a system like this. Our kids and our communities will benefit from robust job training with an unlimited set of pathways that also provides the enormous sense of pride and dignity that comes from paid work, and our businesses will benefit from a highly skilled workforce capable of meeting their needs. This is an exciting effort and I appreciate the commitments of so many leaders to help make this happen.”
Permeability is paramount: Busting the myth that apprenticeship locks you into one job
Many Americans think that Swiss apprentices are forced to choose a career while in their teens and are locked into that one career path. The reality couldn’t be more different.
The notion of “permeability” is extremely important to both young people and employers in the Swiss system. Permeability means someone who completes an apprenticeship in Switzerland can, if they choose, do another apprenticeship or go straight into the workforce, or go on to higher education. It is not uncommon for students to begin their education in an apprenticeship program and then go on to enroll in university, or start in one career but change to something very different after a few years of working. Alternatively, those going to high school who want tangible skills can go on to do apprenticeship afterward.
Here’s how it works:
Just as states in the U.S. are responsible for delivering education services to students, cantons in Switzerland take on primary responsibility for education.
All students complete what they call “compulsory school,” which goes until ninth grade.
Starting in the seventh grade, companies begin doing career fairs. In the eighth grade, young people do trial apprenticeships for anywhere from one to five days in order to determine if that is where they want to apply.
Once a student completes compulsory school, usually around the age of 14 or 15, he or she chooses one of two options: Apprenticeship (70 percent of young people do this path) or high school (30 percent do this path). Both paths can lead to higher education later.
Apprenticeships last three or four years, depending on the type of apprenticeship. Students apply for apprenticeship in the ninth grade, and then start the year after.
These are formalized programs where the apprentices spend three to four days working (and receive pay for their work), and one to two days in a classroom learning with apprentices enrolled in similar apprenticeship programs. There are about 250 professions from which to choose spanning both blue- and white-collar professions such as sports retail, mechanical engineering, banking and hairdressing. Apprentices earn a paycheck, do real work, and gain a nationally recognized credential upon at the completion of their training.
(PAGE 3) OUR HEALTH AND FITNESS
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patientsPress release issued 11/ 22/ 17
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586405.htm
The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses. Refractive error, which is caused when the artificial lens does not focus properly, causes blurred vision.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”
The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.
A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75 percent also had a reduction in astigmatism.
The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases.
The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.
FDA approves first two-drug regimen for certain patients with HIV
Press release issued 11/ 21/ 17
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm
The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
HIV weakens a person’s immune system by destroying important cells that fight disease and infection. According to the Centers for Disease Control and Prevention, an estimated 1.1 million people in the United States are living with HIV, and the disease remains a significant cause of death for certain populations.
Juluca’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue their current anti-HIV drugs or to switch to Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.
The most common side effects in patients taking Juluca were diarrhea and headache. Serious side effects include skin rash and allergic reactions, liver problems and depression or mood changes. Juluca should not be given with other anti-HIV drugs and may have drug interactions with other commonly used medications.
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
Press release issued 11/ 21/ 17
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586117.htm
As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.
Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.
Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.
In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.
These efforts also include the development of new tools for expediting the generic development of complex products. The same features that make drugs hard to manipulate and abuse also make these formulations more complex, and therefore harder to develop generic versions of. To provide a more efficient pathway for the generic entry of these and other complex formulations, the FDA is advancing new review policies. For example, the new guidance will now assist generic drug developers who meet with the agency to discuss scientific and regulatory issues before submitting their applications. These meetings will enable the FDA to clarify the agency’s expectations early in the development process with the goal of reducing the time it takes to obtain approval. We’ll be taking additional steps to facilitate the efficient entry of complex generic drugs in the near future.
Together, all of these efforts are aimed at creating a more robust path for applicants who plan to develop and seek approval of generic ADF opioids. Our goal is, when the use of any opioid drug product is appropriate, to make prescribing of these new formulations more commonplace. But let us be clear on one point. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose, or death. To address these issues, among other steps, we’re currently conducting a study to evaluate whether the nomenclature we use to describe these drugs, by labeling them “abuse deterrent,” is accurately conveying their benefits.
We also recognize that the science of abuse deterrence is relatively new. Both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. That’s why we’re also focusing our efforts on determining how effective the current abuse-deterrent products are in the real-world setting and better understanding the attitudes and beliefs of health care professionals and those who are prescribed these products.
Further, all of these steps shouldn’t be mistaken as an effort that will encourage more opioid use. Our goal is to decrease the rate of new addiction, and thus any unnecessary legitimate and especially illicit use of opioids. Rather, this is an effort designed to encourage the shift – only when opioids are clinically appropriate ‒ from existing, easily abused products to those that are harder to manipulate.
This final guidance is one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis. This effort must include treatments for those who are already addicted. That’s why we are also focusing new efforts on the development and promotion of medication-assisted treatments for addiction. As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction.
Nearly half of the world’s busiest airports have smoke-free policies
CDC press release dated 11/ 22/ 17
https://www.cdc.gov/media/releases/2017/p1122-smoke-free-airports.html
Among the 50 busiest airports in the world, 23 have smoke-free indoor policies. This means air travelers and employees at 46 percent of the world’s busiest airports are protected from exposure to secondhand smoke. The other 27 busiest airports allow smoking in designated or ventilated indoor areas.
The report published in today’s Morbidity and Mortality Weekly Report (MMWR) is the Centers for Disease Control and Prevention’s first assessment of smoke-free policies in the world’s airports. More than 2.7 billion passengers annually pass through the airports included in the study.
Airports were defined as having a smoke-free policy if they completely prohibited smoking in all indoor areas. The 27 airports defined as having no smoke-free policy allowed smoking in designated smoking rooms, restaurants, bars, or airline clubs.
Smoke-free policies protect travelers, workers from secondhand smoke
“The Surgeon General has concluded there is no risk-free level of secondhand smoke exposure,” said Corinne Graffunder, D.Ph., M.P.H., director of CDC’s Office on Smoking and Health. “Even brief exposure can have health consequences.”
The study, which assessed policies in 2017, found significant variations in smoke-free policy status by region. In North America, 78 percent (14 of 18) of the busiest airports have a smoke-free policy; in Europe, 44 percent (4 of 9); in Asia, 18 percent (4 of 22). All four of the Asian airports with a smoke-free policy are in China.
A previous CDC study documented that secondhand smoke can transfer from designated smoking areas into nonsmoking areas in airports, where nonsmoking travelers and employees can be exposed. As a result, travelers and workers are at risk of secondhand smoke exposure in these airports.
“Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot eliminate exposure of nonsmokers to secondhand smoke,” said Brian King, Ph.D., Deputy Director for Research Translation in the Office on Smoking and Health. “People who spend time in, pass by, clean, or work near these rooms are at risk of exposure to secondhand smoke.”
Secondhand smoke causes an estimated 34,000 heart disease deaths and 7,300 lung cancer deaths each year in the United States. Exposure to secondhand smoke from burning tobacco products causes premature death and disease including coronary heart disease, stroke, and lung cancer among nonsmoking adults. In children, it can cause sudden infant death syndrome, acute respiratory infections, middle ear disease, exacerbated asthma, respiratory symptoms, and decreased lung function.
(Page 4) MILKING THE SYSTEM
Former General Counsel of Company That Operates Health Maintenance Organizations in Several States Sentenced to Prison for Role in $35 Million Health Care Fraud SchemePress release issued 11/ 22/ 17
https://www.justice.gov/opa/pr/former-general-counsel-company-operates-health-maintenance-organizations-several-states
The former general counsel of a company that operates health maintenance organizations in several states was sentenced to six months in prison today for his role in a $35 million health care fraud scheme.
Acting Assistant Attorney General Kenneth A. Blanco of the Justice Department’s Criminal Division, Acting U.S. Attorney W. Steven Muldrow of the Middle District of Florida, Special Agent in Charge Shimon Richmond of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Miami Field Office, Special Agent in Charge Eric W. Sporre of the FBI’s Tampa Field Office and the Florida Attorney General’s Medicaid Fraud Control Unit made the announcement.
Thaddeus M.S. Bereday, 52, of Tampa, Florida, was sentenced by U.S. District Judge James S. Moody of the Middle District of Florida, who also ordered Bereday to serve three years of supervised release that includes one year of home confinement following his prison term and to pay a fine in the amount of $50,000. Bereday pleaded guilty on June 27, to one count of making a false statement in connection with health care matters.
According to admissions made in connection with his guilty plea, Bereday served in several positions, including as general counsel, with WellCare Health Plans Inc. (WellCare), a publicly traded corporation that operates health maintenance organizations (HMOs) in several states targeted to government-sponsored health care benefit programs such as Medicaid. Two WellCare HMOs operating in Florida, StayWell and Healthease, contracted with the Agency for Health Care Administration (AHCA), the Florida agency that administers the Medicaid program, to provide Florida Medicaid program recipients with an array of services, including behavioral health services.
In 2002, Florida enacted a statute that required Florida Medicaid HMOs to expend 80 percent of the Medicaid premium they received for certain behavioral health services on the actual provision of those services to beneficiaries. If the HMO expended less than 80 percent of the premium, the law required the excess funds to be returned to the Medicaid Program. Bereday and four other defendants were charged in an indictment that alleged the ways in which the defendants falsely and fraudulently schemed to submit inflated expenditure information in the company’s annual reports to AHCA in order to reduce the WellCare HMOs’ contractual payback obligations for behavioral health care services.
As part of his guilty plea, Bereday admitted that he, along with others, knowingly and willfully caused the submission of a false expenditure report for calendar year 2006 to the Florida Medicaid Program on behalf of Healthease, a WellCare HMO that was under contract to provide health care services to Medicare beneficiaries in Florida in 2006.
On May 5, 2009, the United States reached a resolution with WellCare on related charges. Pursuant to a Deferred Prosecution Agreement (DPA), WellCare was required to pay $40 million in restitution, forfeit another $40 million to the United States and cooperate with the government’s criminal investigation. The company complied with all of the requirements of the DPA. As a result, the criminal Information was later dismissed by the Court following a government motion.
After a 13-week trial in June 2013, a jury found the four other defendants guilty for their roles in a scheme to defraud the Florida Medicaid Program of more than $35 million. Todd S. Farha of Tampa, Florida, former WellCare chief executive officer, was convicted of two counts of health care fraud; Paul L. Behrens of Odessa, Florida, former WellCare chief financial officer, was convicted of two counts of making false statements relating to health care matters and two counts of health care fraud; William L. Kale of Oldsmar, Florida, former vice president of Harmony Behavioral Health Inc. (a wholly owned subsidiary of WellCare), was found guilty of two counts of health care fraud; and Peter E. Clay of Wellesley, Massachusetts, former WellCare vice president of medical economics, was found guilty of making false statements to a law enforcement officer. In May 2014, Judge Moody sentenced Farha to 36 months in prison; Behrens to 24 months in prison; and Kale to one year and one day in prison. Clay was sentenced to serve 5 years’ probation. The defendants appealed their convictions, which were all affirmed by the Eleventh Circuit in August 2016.
This case was investigated by the HHS-OIG, the FBI and the Florida Attorney General's Medicaid Fraud Control Unit. Senior Litigation Counsel John A. Michelich of the Criminal Division’s Fraud Section and Assistant U.S. Attorneys Jay G. Trezevant and Cherie Krigsman of the Middle District of Florida prosecuted the case.
The Fraud Section leads the Medicare Fraud Strike Force. Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged nearly 3,500 defendants who have collectively billed the Medicare program for more than $12.5 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.
Former Pharmacy Compliance Director Pleads Guilty to Introducing Adulterated Drugs into Interstate Commerce and Conspiracy to Defraud the United States
Press release issued 11/ 22/ 17
https://www.justice.gov/opa/pr/former-pharmacy-compliance-director-pleads-guilty-introducing-adulterated-drugs-interstate
The former compliance director of an Indiana compounding pharmacy pleaded guilty to introducing adulterated drugs into interstate commerce and conspiracy to defraud the United States by obstructing the Food and Drug Administration’s (FDA) lawful functions, the Department of Justice announced today.
Caprice R. Bearden, 63, of Carmel, Indiana, pleaded guilty in the Southern District of Indiana to one count of conspiracy to defraud the United States, three misdemeanor counts of introducing an adulterated drug in interstate commerce, and six misdemeanor counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. Bearden was the Director of Compliance for Pharmakon Pharmaceuticals Inc. (Pharmakon). Pharmakon compounded drugs at a facility in Noblesville, Indiana, for customers in various states.
Chief U.S. District Judge Jane E. Magnus-Stinson accepted Bearden’s plea. A date for sentencing has not been sent yet.
"This guilty plea demonstrates the Justice Department’s commitment to protecting patients and ensuring that compounded drugs are safe,” said Principal Deputy Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “Distributing out-of-specification drug products poses a serious risk of harm to patients. The Justice Department will not tolerate efforts to impede FDA’s ability to uncover these types of safety concerns.”
“This defendant distributed serious drugs to hospitals in Indiana and around the country, knowing that the drugs were significantly under or over the strength they were supposed to be,” said Josh Minkler, United States Attorney for the Southern District of Indiana. “She put greed and the reputation of her company ahead of the health and safety of our most vulnerable patient populations.”
As part of her plea agreement, Bearden acknowledged that during 2014 and 2016 FDA inspections, she lied about Pharmakon’s never having received any out-of-specification drug potency test results. Bearden also acknowledged that she knowingly conspired with another individual to defraud the United States by obstructing the lawful functions of the FDA. In addition, she acknowledged that it was the purpose of the conspiracy to prevent the loss of revenue that would result from customers’ and FDA’s knowledge of Pharmakon’s having distributed numerous compounded drugs that were not the strength purported on the drugs’ labeling.
“This is an egregious example of how harmful conduct can result in risk to patients. The disregard for the law resulted in the injury of infants from poorly compounded, super potent morphine products,” said FDA Commissioner Scott Gottlieb, M.D. “We will not tolerate substandard practices, like failing to meet federal manufacturing standards like those found at Pharmakon, that put patients at risk and will aggressively pursue individuals that put profit ahead of patient safety.”
The conspiracy charge to which Bearden pleaded guilty carries a statutory maximum sentence of five years in prison and a fine of $250,000 or twice the gross gain or gross loss from the offense. The misdemeanor charges of distributing an adulterated drug in interstate commerce and adulterating drugs while held for sale after shipment of a drug component in interstate commerce each carry a statutory maximum punishment of one year in prison and a fine of $100,000 or twice the gross gain or gross loss from the offense.
Principal Deputy Assistant Attorney General Readler and U.S. Attorney Minkler commended the FDA Office of Criminal Investigations, which conducted the investigation. Trial Attorney David A. Frank of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Cindy J. Cho, of the U.S. Attorney’s Office for the Southern District of Indiana, are prosecuting the case.
Miami-Area Man Pleads Guilty for Role in $63 Million Health Care Fraud Scheme
DOJ press release issued 11/ 21/ 17
https://www.justice.gov/opa/pr/miami-area-man-pleads-guilty-role-63-million-health-care-fraud-scheme
A Miami-area, Florida man pleaded guilty today for his role in a $63 million health care fraud scheme involving a now-defunct community mental health center located in Miami that purported to provide partial hospitalization program (PHP) services to individuals suffering from mental illness.
Acting Assistant Attorney General Kenneth A. Blanco of the Justice Department’s Criminal Division, Acting U.S. Attorney Benjamin G. Greenberg of the Southern District of Florida, Special Agent in Charge Robert Lasky of the FBI’s Miami Field Office and Special Agent in Charge Shimon R. Richmond of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Miami Regional Office made the announcement.
Samuel Konell, 70, of Boca Raton, Florida, pleaded guilty to one count of conspiracy to defraud the United States and to receive health care kickbacks before U.S. District Judge Jose E. Martinez of the Southern District of Florida. Sentencing has been scheduled for Jan. 30 before Judge Martinez. Konell was charged in an indictment unsealed on June 9.
As part of his guilty plea, Konell admitted that from approximately January 2006 through June 2012, he received kickbacks and/or bribes in return for referring Medicare beneficiaries from the Miami-Dade state court system to Greater Miami Behavioral Healthcare Center Inc. (Greater Miami) to serve as patients.
Specifically, Konell admitted that he coordinated with criminal defendants in the state court system to obtain court orders for mental health treatment in lieu of incarceration so that Konell could refer those individuals to Greater Miami to serve as patients in return for kickbacks and/or bribes. Konell further admitted that he did so knowing that certain of those individuals were not mentally ill or otherwise did not meet the criteria for PHP treatment.
In addition, Konell admitted that he and his co-conspirators at Greater Miami took steps to disguise the true nature of the kickbacks and/or bribes that Greater Miami paid to Konell and other patient brokers. Specifically, Konell was placed on the Greater Miami payroll to make the kickbacks and/or bribes appear as though they were legitimate salary payments, Konell admitted.
Konell further admitted that he was originally paid a flat monthly rate that was based on the number of patients he referred to Greater Miami from the state court system, and when Konell referred more patients to Greater Miami, his co-conspirators found ways to pay him over and above his regular kickback payments, including by providing him with holiday bonuses.
In furtherance of the kickback conspiracy, Konell made representations to judges and others in the Miami-Dade state court system that the individuals he referred to Greater Miami received medically necessary PHP services from Greater Miami when in reality such services were not always needed, he admitted.
According to plea documents, Konell’s co-conspirators caused the submission of over $63 million in false and fraudulent claims to Medicare. These claims were based on kickbacks and/or bribes paid to Konell and others and were for services that were medically unnecessary, were not eligible for Medicare reimbursement or were never provided by Greater Miami. Konell admitted that his participation in the Greater Miami scheme resulted in the submission of claims to Medicare totaling between at least approximately $9.5 and $25 million.
Eleven other individuals have pleaded guilty for their roles in the scheme, including the owner of Greater Miami, three administrators and seven patient brokers.
This case was investigated by the FBI and HHS-OIG and was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Southern District of Florida. Senior Trial Attorney Christopher J. Hunter and Trial Attorneys Elizabeth Young and Leslie Wright of the Fraud Section are prosecuting the case.
The Medicare Fraud Strike Force operations are part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The Medicare Fraud Strike Force operates in nine locations nationwide. Since its inception in March 2007, the Medicare Fraud Strike Force has charged over 3,500 defendants who collectively have falsely billed the Medicare program for over $12.5 billion.
Owner of Two Miami Home Health Agencies Sentenced to More Than Six Years in Prison for Role in $74 Million Medicare Fraud Conspiracy
DOJ press release issued 11/ 21/ 17
https://www.justice.gov/opa/pr/owner-two-miami-home-health-agencies-sentenced-more-six-years-prison-role-74-million-medicare
he owner and operator of two defunct Miami home health agencies was sentenced today to 80 months in prison for her role in a $74 million conspiracy to defraud the Medicare program.
Acting Assistant Attorney General Kenneth A. Blanco of the Justice Department’s Criminal Division, Acting U.S. Attorney Benjamin G. Greenberg of the Southern District of Florida, Special Agent in Charge George L. Piro of the FBI’s Miami Field Office, and Special Agent in Charge Shimon R. Richmond of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Miami Regional Office made the announcement.
Sila Luis, 59, of Miami, Florida, was sentenced by U.S. District Judge Marcia G. Cooke of the Southern District of Florida. Judge Cooke also ordered the defendant to pay $45 million in restitution and to forfeit the gross proceeds traced to the offense. Luis pleaded guilty on June 28, to one count of conspiracy to commit health care fraud.
As part of her guilty plea, Luis admitted that, between January 2006 and June 2012, she and her co-conspirators agreed to, and actually did, operate LTC Professional Consultants Inc. (LTC) in order to fraudulently bill the Medicare program for home health care services, including diabetic injections, skilled nursing visits, physical therapy, and other treatments and services. Professional Home Care Solutions Inc. was another home health agency under Luis’s ownership and control that was involved in the conspiracy. Luis further admitted that she and her co-conspirators enlisted and paid patient recruiters kickbacks and bribes in exchange for the referral of Medicare beneficiaries to LTC. Had Medicare known that Luis paid bribes and kickbacks to attract beneficiaries to her facilities, Medicare would not have paid any claims submitted on behalf of those beneficiaries.
Judge Cooke determined at sentencing that Luis was responsible for an intended loss of $74 million to the Medicare program.
Luis was charged along with Elsa Ruiz, 49, and Myriam Acevedo, 68, both of Miami, Florida, in an indictment returned on Oct. 3, 2012. Acevedo pleaded guilty in May 2013 to conspiracy to pay health care kickbacks and payment of kickbacks in connection with a federal health care benefit program. She was sentenced to 60 months in prison and ordered to pay $27 million in restitution. Ruiz pleaded guilty to conspiracy to commit health care fraud. She was sentenced to 80 months in prison and ordered to pay $45 million in restitution.
The FBI and HHS-OIG investigated this case. Trial Attorneys David Snider, Patrick Mott, and L. Rush Atkinson of the Criminal Division’s Fraud Section are prosecuting the case.
The Fraud Section leads the Medicare Fraud Strike Force, which is part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The Medicare Fraud Strike Force operates in nine locations nationwide. Since its inception in March 2007, the Medicare Fraud Strike Force has charged over 3,500 defendants who collectively have falsely billed the Medicare program for over $12.5 billion.
SEATTLE TIMES EDITORIAL SPOTLIGHT
Gutting net neutrality rules is a giant step backwardhttps://www.seattletimes.com/opinion/editorials/gutting-net-neutrality-rules-is-a-giant-step-backward/
Americans should tell the FCC and members of Congress that net-neutrality rules are needed to prevent throttling and discrimination of online content and information.
Quote: " The last thing Americans need during the holidays is more stress about politics, but that’s what they’re getting from President Donald Trump’s administration.
Now more than ever, the public must stay engaged and ensure their voices are heard as the administration continues its relentless bulldozing of policies and rules protecting the public.
The latest is Federal Communications Chairman Ajit Pai’s noxious proposal to erase net-neutrality protections established in 2015. Pai unveiled his plan Tuesday, and it may be approved at the Republican-controlled FCC’s Dec. 14 meeting."
Related press release issued from Congressman Kilmer dated 11/ 22/ 17
http://kilmer.house.gov/news/press-releases/kilmer-statement-in-support-of-net-neutrality
Kilmer Statement in Support of Net Neutrality
TACOMA, WA—Following the FCC’s announcement of a plan to repeal key regulations that ensure equal access to the internet, Rep. Derek Kilmer (D-WA) released the following statement:
“I support net neutrality and believe we must protect a free and open internet. I oppose the Trump Administration proposal put forward today because it would stifle innovation and harm consumers. The FCC should reject this proposal, and instead Congress should update telecommunications laws and make sure they are relevant to today’s economy.”
Petition not to repeal Net Neutrality
Do Not Repeal Net Neutrality
Net Neutrality (NN) makes it illegal for ISPs to "throttle" your internet content. Throttling allows them to choose how fast, and even if, you can have functional access to certain websites. This paves the way for having different plans for different speeds you can visit websites. Currently you can use the internet at full speed for all websites. With Net Neutrality repealed not only would you pay for the internet service but you would pay for one of their plans to allow faster internet.
In 2016, the public and United States Appeals Court disapproved of an effort to repeal NN. We are aware that repealing NN will only benefit the monopolized internet service providers. The public overwhelming has its best interests in NN as it protects the consumer, and thus we stand to keep NN in effect.
https://petitions.whitehouse.gov/petition/do-not-repeal-net-neutrality
Editorial Comment: I signed the above petition on the White House webpage, because I changed my views on the subject, I think the internet shouldn't be restricted to anyone. At first I thought this was about the government intruding on online commerce. But, after getting a better understanding on the issue I can see the merits of it. It wasn't government that was telling people what they should be allowed to go on the net, it was big business.
WEEKLY BIBLE STUDY
Should Preachers Wear Honorary Titles?
What terms should we use to refer to preachers? The Bible uses many different terms, such as "evangelist," "teacher," and "minister" (Acts 21:8; 13:1; 1 Thessalonians 3:2). All these words describe different aspects of the work preachers do. But consider some of the titles people today sometimes use.---Gospel Way
https://www.gospelway.com/topics/teaching/preacher-titles.php
