Several pharmaceutical executives and managers, formerly employed by Insys Therapeutics, Inc., were arrested today on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers.
The indictment alleges that Michael L. Babich, 40, of Scottsdale, Ariz., the former CEO and President of the company; Alec Burlakoff, 42, of Charlotte, N.C., former Vice President of Sales; Richard M. Simon, 46, of Seal Beach, Calif., former National Director of Sales; former Regional Sales Directors, Sunrise Lee, 36, of Bryant City, Mich. and Joseph A. Rowan, 43, of Panama City, Fla.; and former Vice President of Managed Markets, Michael J. Gurry, 53, of Scottsdale, Ariz., conspired to bribe practitioners in various states, many of whom operated pain clinics, in order to get them to prescribe a fentanyl-based pain medication. The medication, called *Subsys, is a powerful narcotic intended to treat cancer patients suffering intense episodes of breakthrough pain. In exchange for bribes and kickbacks, the practitioners wrote large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer.
The indictment also alleges that the now former corporate executives charged in the case conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients. They achieved this goal by setting up the ‘reimbursement unit’ which was dedicated to obtaining prior authorization directly from insurers and pharmacy benefit managers.
“Patient safety is paramount and prescriptions for these highly addictive drugs, especially Fentanyl, which is among the most potent and addictive opioids, should be prescribed without the influence of corporate money,” said United States Attorney Carmen M. Ortiz. “I hope that today’s charges send a clear message that we will continue to attack the opioid epidemic from all angles, whether it is corporate greed or street level dealing.”
“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division. “In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety. These indictments reflect the steadfast commitment of the FBI and our law enforcement partners to confront the opioid epidemic impacting our communities, while bringing to justice those who seek to profit from fraud or other criminal acts.”
“We take allegations of paying kickbacks to physicians in exchange for prescribing medically unnecessary painkillers extremely seriously,”said Special Agent in Charge Phillip Coyne of the US Department of Health and Human Services, Office of the Inspector General. “Working closely with our law enforcement partners, we will continue to protect the health of Medicare beneficiaries and the integrity of the nation’s healthcare system.”
The defendants were arrested in their respective states and will appear in US District Court in Boston at a later date. Babich is charged with conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law; Burlakoff, Simon, Lee and Rowan are charged with RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law; Gurry is charged with RICO conspiracy and wire fraud conspiracy.
My Mother’s Cookbook’s Holiday Desserts: Pumpkin and Pecan Pies, Gingerbread Men and Christmas Cookies
Food comes immediately to mind when reflecting on the holidays of my childhood. I remember sitting by a window near the kitchen stove, basking in the warmth of the winter sun behind me while playing with my most prized present that year, an oil painting set. Not old enough to be expected to help, I watched my mother preparing our Christmas dinner and asked her more than once how much longer until the special meal was ready.
Dad liked a bowl of mixed nuts in their shells — walnuts, almonds, hazel nuts and pecans — for snacks during the holidays. Sometimes we had Brazil nuts, their exotic shells so dark and oddly shaped that I thought them too strange to eat.
Mom would put the nut bowl in the library, with nut crackers and pickers at the ready. We children enjoyed the laborious task of cracking nuts, picking out the tasty meats and eating them. Pieces of shell must have been scattered on the floor, but we lived in a household where some messiness related to eating was tolerated.
Mother wasn’t big on desserts and didn’t serve them after every meal. She paid more attention to the savory dishes she created, although she was fond of pies. People usually excel at cooking what they like best to eat, and her pies proved that point. Pie almost always finished off our holiday meals.
Except for one unfortunate year, when Mom steamed carrot pudding on the stove for hours and served it with hard sauce. I didn’t like the dense sticky pudding or the sweet sauce. This must have been the family consensus, because the carrot pudding never showed up again.
Pumpkin pie is surely the most popular dessert served for Thanksgiving dinner in our country. The recipe Mom favored came from Bernice Lewis. A widow older by some years, she had been Mom’s closest friend from the time she first came to Harlan as a young bride. Bernice had an especially jolly sense of humor, and Mom loved to laugh.
More at: http://seniorwomen.com/articles/cullison/articlesCullisonHolidayDesserts.html
Prescription Drug Labels: Actions Needed to Increase Awareness of Best Practices for Accessible Labels Blind or Visually Impaired
What GAO Found
GAO found that some pharmacies can provide accessible prescription drug labels, which include labels in audible, braille, and large print formats and are affixed to prescription drug containers.
Mail order pharmacies: Four pharmacy benefit managers (PBMs) used by large insurers that GAO contacted reported that they can provide accessible labels through their mail order pharmacies.
Retail pharmacies: Six of the 9 largest chain pharmacy companies and 8 of the 18 selected individual retail pharmacy locations GAO contacted also reported that they can provide accessible labels through their store-based retail pharmacies.
The percent of prescriptions dispensed with accessible labels was generally low — less than one percent of all prescriptions dispensed—according to some PBMs and chain pharmacy companies that GAO contacted. With regard to best practices, a working group convened by the US Access Board — a federal agency that promotes accessibility for individuals with disabilities — developed and published 34 best practices for accessible labels. Four PBMs, six chain pharmacy companies, and eight individual retail pharmacy locations GAO contacted reported that they have generally implemented most of the 34 best practices for accessible labels. However, stakeholders GAO contacted said that individuals who are blind or visually impaired continue to face barriers accessing drug label information, including identifying pharmacies that can provide accessible labels.
Stakeholders GAO contacted identified four key challenges that pharmacies faced in providing accessible labels or implementing the best practices: (1) lack of awareness of the best practices; (2) low demand and high costs for providing accessible labels; (3) technical challenges for providing these labels; and (4) an absence of requirements to implement the best practices. Many stakeholders identified greater dissemination of the best practices as a step, among others, that could help address some of these challenges.
The National Council on Disability (NCD) — the federal agency responsible for conducting an informational campaign on the best practices, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) — has conducted limited campaign activities. Primarily in 2013 and 2014, NCD used its website and social media to disseminate an agency statement and press releases on the best practices. However, most stakeholders GAO spoke with said they had no communication with NCD about its campaign, and some said they were unaware of the best practices. Agency officials provided GAO with an original plan for conducting campaign activities through 2014, but most activities were not conducted. During the course of our review, NCD developed a corrective action plan for conducting future campaign activities. However, neither plan assigned responsibilities for conducting these activities nor does the agency have plans to evaluate them, which is inconsistent with federal internal control standards. Without assigning responsibilities and developing an evaluation plan, NCD will be unable to adjust its action plan and assess whether the information on the best practices is effectively reaching its target audience.
Why GAO Did This Study
About 7.4 million Americans are blind or visually impaired and may face difficulty reading prescription drug container labels. FDASIA required the US Access Board to develop best practices for accessible labels and NCD to conduct an informational campaign on these best practices.
FDASIA also included a provision for GAO to review pharmacies’ implementation of these best practices. This report examines: the extent to which pharmacies can and do provide accessible labels and implement the best practices; pharmacy challenges; and the extent to which NCD conducted its informational campaign, among others.
GAO collected information from 55 stakeholders, including 4 PBMs used by large insurers; 9 of the largest chain pharmacy companies; 18 randomly selected individual retail pharmacy locations in 4 states with varying levels of visually impaired residents; and 24 others, such as state regulating bodies and advocacy and industry groups. GAO sent a web-based questionnaire to PBMs, chain pharmacy companies, and individual retail pharmacy locations. GAO also interviewed stakeholders and reviewed state regulations and documents from NCD.
What GAO Recommends
NCD should assign responsibility for conducting campaign activities and evaluate these activities. NCD neither agreed nor disagreed with the recommendation but indicated that it is taking steps to address this issue.
For more information, contact John Dicken at (202) 512-7114 or dickenj@gao.gov.
“Like Putting an Arsonist in Charge of Fighting Fires”; “[Pruitt] Has Fought Environmental Protection Agency Pollution Limits on Toxic Substances Like Soot and Mercury”
The following is a statement from Earthjustice President Trip Van Noppen in response to President-elect Trump’s nomination of Scott Pruitt, a climate-change denier, to head the Environmental Protection Agency:
“Every American should be appalled that President-elect Trump just picked someone who has made a career of being a vocal defender for polluters to head our Environmental Protection Agency.
“We all rely on the Environmental Protection Agency to enforce our clean air and clean water laws to keep us safe from toxic pollution. The leader of this agency should respect the importance of our bedrock environmental laws, be guided by science to make informed decisions and, above all, place the health of our families and communities above corporate profits.
“Scott Pruitt possesses none of these values. He has long opposed responsible rules for cutting toxic pollution, including the EPA’s Clean Power Plan [for Existing Power Plants], and he’s been in lockstep with the oil industry for years.
“He’s been so cozy with polluter lobbyists that he let them draft comments about federal pollution limits, changed a few words, then copied it onto his official Oklahoma Attorney General stationery and submitted it as the comments of the people of Oklahoma.
“He has fought Environmental Protection Agency pollution limits on toxic substances like soot and mercury that put us all at risk for increased cancer, childhood asthma and other health problems. He falsely claims that fracking doesn’t contaminate drinking water supplies.
“The media uncovered that he’s been part of a secretive, coordinated national corporate campaign to undo the federal pollution protections that are supposed to keep our air and water clean. In exchange, the oil industry has reciprocated with campaign contributions.
“Polluters would clearly be the ones who benefit from Pruitt being the Environmental Protection Agency Administrator. Regular Americans would be the losers.
“Earthjustice strongly believes that President-elect Trump should retract this announcement or the Senate should reject this nomination.
“The head of the Environmental Protection Agency should be making sure that our air is clean to breathe and our water is safe to drink, not working to make sure polluters make more money.
“Despite the wealth of research worldwide documenting the connection between CO2 emissions from pollution and climate change, Pruitt has cast doubt about whether global warming is related to human activity. Anyone who doesn’t believe in scientific research is completely unqualified to lead the primary federal agency tasked with addressing this issue.”
Elaine Soloway’s Rookie Widow Series: Tommy Has Boundaries; Full Disclosure; Tommy Intervenes
Tommy Has Boundaries
Why Trump Would Almost Certainly Be Violating the Constitution If He Continues to Own His Businesses
Far from ending with President-elect Trump’s announcement that he will separate himself from the management of his business empire, the constitutional debate about the meaning of the Emoluments Clause — and whether Trump will be violating it — is likely just beginning.
Editor’s Note: One version of the diamond-encrusted gift given to Benjamin Franklin by the King of France
That’s because the Emoluments Clause seems to bar Trump’s ownership of his business. It has little to do with his management of it. Trump’s tweets last Wednesday said he would be “completely out of business operations.“
The Emoluments Clause bars US officials, including the president, from receiving payments from foreign governments or foreign government entities unless the payments are specifically approved by Congress. As ProPublica and others have detailed, Trump’s business has ties with foreign government entities ranging from loans and leases with the Bank of China to what appear to be tax-supported hotel deals in India and elsewhere. The full extent of such ties remains unknown, and Trump has refused to disclose them, or to make public his tax returns, through which many such deals, if they exist, would be revealed. Foreign government investments in Trump entities would also be covered by the clause, as would foreign government officials paying to stay in Trump hotels, so long as Trump stands to share in the revenues.
One misconception about the Emoluments Clause in early press coverage of it in the wake of Trump’s election is being clarified as scholars look more closely at the provision’s history. That was the suggestion that it would not be a violation for the Trump Organization to conduct business with foreign government entities if “fair market value” was received by the governments.
This view had been attributed to Professor Richard Painter, a former official of the George W. Bush administration, and privately by some others. But Professor Laurence Tribe, the author of the leading treatise on constitutional law, and others said the Emoluments Clause was more sweeping, and mandated a ban on such dealings without congressional approval. Painter now largely agrees, telling ProPublica that no fair market value test would apply to the sale of services (specifically including hotel rooms), and such a test would apply only to the sale of goods. The Trump Organization mostly sells services, such as hotel stays, golf memberships, branding deals and management services.
The Emoluments Clause appears in Article I, Section 9 of the Constitution. It bars any “person holding any office of profit or trust under” the United States from accepting any present, Emolument, Office, or Title, of any kind whatever, from any King, Prince, or foreign state” “without the consent of the Congress.” The word “emolument” comes from the Latin emolumentum, meaning profit or gain. The language of the clause was lifted in its entirety from the Articles of Confederation which established the structure of the government of the United States from 1781 until the ratification of the Constitution in 1788-89. The clause was derived from a Dutch rule dating to 1751.
The clause was added to the draft Constitution at the Constitutional Convention on Aug. 23, 1787 on a motion by Charles Pinckney of South Carolina. As Gov. Edmund Randolph of Virginia explained to his state’s ratification convention in 1788, Pinckney’s motion was occasioned by Benjamin Franklin, who had been given a snuffbox, adorned with the royal portrait and encrusted with small diamonds, by Louis XVI while serving as the Continental Congress’s ambassador to France. As Randolph said,
“An accident which actually happened, operated in producing the restriction. A box was presented to our ambassador by the king of our allies. It was thought proper, in order to exclude corruption and foreign influence, to prohibit any one in office from receiving emoluments from foreign states.”
The Continental Congress in 1786 had consented, after a debate, to Franklin keeping the snuffbox, as it had earlier with a similar gift to envoy Arthur Lee. At the same time, consent also was given to diplomat John Jay receiving a horse from the King of Spain.
Congressional Actions: Sexual Harassment & Gender Discrimination at Agriculture Department; Considering the 21st Cent.Cures Act
On December 1, the House Committee on Oversight and Government Reform held a hearing entitled Examining Sexual Harassment and Gender Discrimination at the U.S. Department of Agriculture (USDA). The purpose of the hearing was to address ongoing misconduct, sexual harassment, and gender discrimination in the U.S. Forest Service and examine the USDA’s management of its Civil Rights Office and its handling of Equal Employment Opportunity (EEO) claims.
The hearing is in response to widespread media coverage and reporting of sexual harassment of female employees at the Forest Service. One of the witnesses, Ms. Denise Rice, testified in her capacity as a whistleblower about her own experience of sexual assault, reporting, and retaliation. https://oversight.house.gov/hearing/examining-sexual-harassment-gender-discrimination-u-s-department-agriculture/
The following witnesses testified:
- The Honorable Joe Leonard, Jr., assistant secretary for Civil Rights, Department of Agriculture;
- Ms. Lenise Lago, deputy chief of business operations, Forest Service, Department of Agriculture;
- Ms. Lesa Donnelly, vice president of the USDA Coalition of Minority Employees/Federal Employee Advocate, former Forest Service employee; and
- Ms. Denise Rice, fire prevention technician, Region 5 Eldorado National Forest, Forest Service, Department of Agriculture
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This Week: Floor Action: Health- On Monday, the Senate is scheduled to consider H.R. 34, the 21st Century Cures Act. ( In the news
21st Century Cures Act passed overwhelmingly by House, major health reform bill moves to Senate
IPWatchdog.com – 1 day ago
The 21st Century Cures Act has broad bipartisan support, passing in the U.S. House by an … Weekly Address: Pass the 21st Century Cures Act
The White House – 2 days ago
Grab Bag Of Goodies In 21st Century Cures Act
Kaiser Health News – 3 days ago
More news for 21st century cures act International- On Monday, the House is scheduled to consider S. 1635, the Department of State Operations Authorization and Embassy Security Act. Later in the week, the Senate is scheduled to consider S. 2943, the FY2017 National Defense Authorization Act. The House also is scheduled to consider a continuing resolution to fund the government through the beginning of next year. Markups: Education- On Tuesday, the Senate Foreign Relations Committee will begin consideration of several bills, including H.R. 4481, the Education for All Act. H.R. 4481: Education for All Act of 2016. To amend the Foreign Assistance Act of 1961 to provide assistance for developing countries to promote quality basic education and to establish the goal of all children in school and learning as an objective of the United States foreign assistance policy, and for other purposes.Feb 4, 2016
Education for All Act of 2016 (H.R. 4481) – GovTrack.ushttps://www.govtrack.us/congress/bills/114/hr4481
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Bills Introduced:
Employment
S. 3489—Sen. Cory Booker (D-NJ)/Judiciary (12/1/16)—A bill to prohibit a court from awarding damages based on race, ethnicity, gender, religion, or actual or perceived sexual orientation, and for other purposes.
H.R. 6417—Rep. Joe Kennedy (D-MA)/Judiciary (12/1/16)—A bill to prohibit a court from awarding damages based on race, ethnicity, gender, religion, or actual or perceived sexual orientation, and for other purposes.
Small Business
H.R. 6398—Rep. Steve Israel (D-NY)/Small Business (11/29/16)—A bill to provide for the inclusion of unmarried women in the criteria for awarding a grant to a women’s business center.
Courtesy of Women’s Policy Inc with some link additions
A Victory for Protestors at Standing Rock Reservation: Army Will Not Grant Easement for Dakota Access Pipeline Crossing
The Department of the Army will not approve an easement that would allow the proposed Dakota Access Pipeline to cross under Lake Oahe in North Dakota, the Army’s Assistant Secretary for Civil Works announced today.
Jo-Ellen Darcy, Assistant Secretary of the Army (Civil Works), said she based her decision on a need to explore alternate routes for the Dakota Access Pipeline crossing. Her office had announced on November 14, 2016 that it was delaying the decision on the easement to allow for discussions with the Standing Rock Sioux Tribe, whose reservation lies 0.5 miles south of the proposed crossing. Tribal officials have expressed repeated concerns over the risk that a pipeline rupture or spill could pose to its water supply and treaty rights.
Above: Map author Carl Sack, via Wikipedia
“Although we have had continuing discussion and exchanges of new information with the Standing Rock Sioux and Dakota Access, it’s clear that there’s more work to do,” Darcy said. “The best way to complete that work responsibly and expeditiously is to explore alternate routes for the pipeline crossing.”
Darcy said that the consideration of alternative routes would be best accomplished through an Environmental Impact Statement with full public input and analysis.
The Dakota Access Pipeline is an approximately 1,172 mile pipeline that would connect the Bakken and Three Forks oil production areas in North Dakota to an existing crude oil terminal near Pakota, Illinois. The pipeline is 30 inches in diameter and is projected to transport approximately 470,000 barrels of oil per day, with a capacity as high as 570,000 barrels. The current proposed pipeline route would cross Lake Oahe, an Army Corps of Engineers project on the Missouri River.
Right, Jo-Ellen Darcy, Ms. Jo-Ellen Darcy, the Assistant Secretary of the Army (Civil Works), establishes policy direction and provides supervision of the Department of the Army functions relating to all aspects of the US Army Corps of Engineers’ Civil Works program
Obama Says Alternate Routes Are Being Reviewed for Dakota Pipeline
Hubert de Givenchy and Muse, Audrey Hepburn
Editor’s Note: We recently viewed The Nun’s Story
Gemeentemuseum Den Haag presents an ambitious exhibition in which couturier Hubert de Givenchy pays homage to his muse, Audrey Hepburn. The exhibition, open until 26 of March 2017, is a grand retrospective of the work of French couturier Hubert de Givenchy, one of the leading fashion designers of the 20th century. His career ran concurrent to that of Christian Dior and Cristóbal Balenciaga and he is a living legend in the history of haute couture.
Hubert de Givenchy, ensemble, fall 1960, worn by Audrey Hepburn in ‘Breakfast at Tiffany’s (1961). Collection Gemeentemuseum Den Haag
The exhibition is being curated in close consultation with Monsieur Hubert de Givenchy and gives a unique insight into his career, which spanned a period of half a century, from the opening of his fashion house in 1952 through to his retirement from it in 1995. Part of the exhibition focuses specifically on the unique friendship and professional collaboration between Hubert de Givenchy and actress Audrey Hepburn. Their creative partnership began in 1953 and endured for the remainder of Hepburn’s life. Audrey Hepburn wore Givenchy creations in some of her most renowned films, such as How to Steal a Million and Breakfast at Tiffany’s. She once said, ‘Givenchy’s clothes are the only ones I feel myself in. He is more than a designer, he is a creator of personality.’
Researchers Warn of Financial Risks in Retirement Jobs: Rethink Those SSA Benefit Calculations
Many workers heading into retirement are woefully unprepared financially and have no idea of the tax impacts of taking on a part-time job to ease the fiscal pain, researchers warn. (Image courtesy of Creative Commons)
Any of the 10,000 Baby Boomers retiring every day who are contemplating a second job in their retirement may want to reconsider, due to an unfamiliar network of federal and state taxes that can serve as significant work disincentives, advises a University of California, Berkeley, economist and professor of law and a team of fellow researchers.
In Is Uncle Sam Inducing the Elderly to Retire? a working paper published by the National Bureau of Economic Research, a team that includes Alan Auerbach, a UC Berkeley professor and director of the Robert D. Burch Center for Tax Policy and Public Finance at UC Berkeley, suggests that prospective retirees can forget the Social Security Administration-provided benefit calculations that come in the mail.
“They’re completely meaningless,” says Auerbach. He says they simply don’t factor in the implicit and explicit taxes that those ages 50 through 79 face from the offsets between income, age and benefits. Auerbach said the research highlights a need for much more transparency in the nation’s retirement and fiscal systems. The Social Security Administration could provide the information, he said, but likely needs a push to do so by “someone in government who thinks it’s important.” That someone, Auerbach suggested, could be in the presidential administration or in Congress.
Auerbach and his fellow researchers — Laurence Kotlifkoff, of Boston University and the Fiscal Analysis Center; Darryl Koehler, of Economic Security Planning Inc. and the Fiscal Analysis Center; and Manni Yu, of Boston University — did the math using data collected from older respondents to the Federal Reserve’s 2013 Survey of Consumer Finances and special software they developed.
The Fiscal Analyzer incorporates all major federal and state fiscal programs — such as federal corporate income tax, personal federal and state income taxes, state sales taxes, estate taxes, Social Security benefits, food stamps, disability benefits, Medicare and Medicaid benefits and premiums and Federal Insurance Contributions Act (FICA) taxes — and calculates remaining lifetime marginal net tax rates.
“We find that working longer, say an extra five years, can raise older workers’ sustainable living standards,” they report in their paper.
Taking a second job to supplement income during retirement can prove costly, researchers warn. (Creative Commons photo)
But the researchers report the impact is far smaller than suggested, in large part due to high net taxation of labor earnings. They also warn that many boomers now face or will face extremely high work disincentives arising from the hodgepodge and uncoordinated design of the nation’s fiscal system.
“Our findings show that older workers typically face high, very high or remarkably high marginal net taxation on their extra earnings,” they write, adding that work disincentives are highest for those at the bottom and top levels of resource distribution.
Don’t let the door hit you…
“Our findings suggest that Uncle Sam is, indeed, inducing the elderly to retire,” they conclude. “Of particular concern is Medicaid and Social Security’s complex earnings test and clawback of disability benefits,” the researchers summarized. A clawback is the recovery of funds disbursed by a company, pension or government. “But an open question is the extent to which the elderly correctly perceive these disincentives,” the report says. “Indeed … it’s hard to believe that policymakers, themselves, are cognizant of the level and spread of the work disincentives they are imposing on the elderly.”
The researchers found that the marginal net tax rate linked to a significant increase in retirement earnings, such as $20,000 a year from a part-time job, can for many elderly be “dramatically higher than that associated with earning a relatively small, say $1,000 a year, extra amount of money.”