“Influence Peddling”: Scott Brown Backed Letter For Top Legislative Priority Of Compounding Pharmacy Industry
Senator Scott Brown joined 10 other senators in sending a July letter to the US Drug Enforcement Administration advocating a top legislative priority of the compounding pharmacy industry, which is under scrutiny following a deadly meningitis outbreak.
The July 24 letter did not directly relate to the injectable steroids that have been blamed for 14 deaths and at least 185 sicknesses nationwide. But it addressed an issue central to that controversy: how these lightly regulated pharmacies can deliver their drugs and who can receive them.
The firm at the center of the meningitis outbreak, the New England Compounding Center, was sending drugs in bulk to doctors, a move that Governor Deval Patrick said has misled regulators. Compounding pharmacies are supposed to mix medications for an individual patient, based on a prescription from a doctor. But some have acted like drug companies, shipping thousands of doses to clinics and doctors’ offices, a practice Massachusetts officials say may violate state regulations.
Gregory Conigliaro, a co-owner of the New England Compounding Center in Framingham, and his wife threw a fund-raising event for Brown six weeks after the letter was written, at their home in Southborough. Brown’s campaign said he has received about $10,000 from the firm’s executives and relatives, which he donated to charity this week after the outbreak, which was traced to New England Compounding Center on Oct. 4. The senator is in a tight reelection battle against Democrat Elizabeth Warren.
For years, compounding pharmacies have delivered controlled substances, in bulk, to clinics, veterinarians, and other health facilities for use there, according to two specialists in the field. But in recent years, the DEA has interpreted federal law as requiring those pharmacies to deliver the drugs to patients whose names are on the prescription, or to owners, in the case of animals. The DEA argues that it is not a change in interpretation, enforcement, or policy and that agents pursue leads about violations whenever they are known.
The industry position, echoed by Brown Friday, argues that the DEA’s interpretation creates a paramount safety concern. Industry officials say that medical professionals are in a better position to protect the drugs, which include strong opiates, from misuse or improper environmental conditions. Many must be injected by physicians and are sensitive to heat and light.
“As you know, they sometimes fall into the wrong hands,” Brown said Friday during an event in Dorchester, where he received endorsements from a coalition of police unions. “I was advocating getting it to the doctors, which I don’t think loosens regulations.”
But changing or clarifying DEA enforcement policy is also important to helping the industry avoid a legal gray area that could jeopardize its business, said Jesse C. Vivian, professor of pharmacy practice at Wayne State University in Detroit and the general counsel for the Michigan Pharmacists Association. Vivian and others say enforcement is now selective, meaning compounding pharmacies are at risk if DEA agents choose to crack down on them.
“What they’re really looking for is to legitimize what in fact they’re doing right now,” said Vivian, who is not involved in the industry’s lobbying effort, but believes the DEA is treating the industry unfairly.
The letter to the DEA’s top official, Michele M. Leonhart, was signed by a bipartisan group of senators. When a smaller group of senators signed a similar letter in 2011, Brown did not lend his support.
The July letter implores the DEA to open what is known as a rule-making process, which would allow the agency to take public input on whether it is interpreting current law correctly.
“DEA’s lack of action is a source of serious concern for us, our constituents, and the regulated community,’’ wrote the senators, including Brown.
“It is difficult to argue that controlled substances are more safely maintained by family members or animal owners than they are by trained, licensed, regulated doctors who would administer those substances only to legitimate patients,” it continued.
Brown emphasized Friday that the type of drugs covered by the letter are different from the steroids involved in the meningitis outbreak, and he once again urged a full investigation of the outbreak. He said that the Food and Drug Administration, not the DEA, oversees the safety of drugs at the center of the meningitis problem.
Brown referred inquiries about who asked him to sign the DEA letter to his campaign, which has declined to comment on that question. But Brown said there was absolutely no connection between his signing the letter and his fund-raising from industry officials.
“It’s a tragedy, and for anyone to try and politicize it is just wrong,” he said. “I’ve had hundreds and hundreds of fundraisers. There’s absolutely no connection. That’s the old spaghetti-on-the-wall-trick, see what sticks.”
His campaign has said he would donate the $10,000 that came from company executives to the Meningitis Foundation of America.
The compounding pharmacy industry’s lobby, the International Academy of Compounding Pharmacists, lists the delivery issue raised in the letter as the first of three legislative priorities on its website. In June, a month before the letter was written, members of the organization descended on Capitol Hill to make their case, according to the website, seeking face-to-face visits with lawmakers. A spokesman for the organization did not respond to two calls and an e-mail requesting comment.
The DEA says it has no latitude in changing its enforcement of the Controlled Substances Act, which governs how drugs can be delivered, unless Congress acts.
“We have to enforce the law the way it’s written,” spokeswoman Barbara Carreno said.
By:Noah Bierman and Frank Phillips, The Boston Globe, October 12, 2012
“Pilfering The Federal Treasury”: Mitt Romney’s Medicaid Shell Game
Mitt Romney is lambasting federal aid in his campaign for the presidency, including derisive comments against those who receive government assistance. But he pulled all the stops to pursue federal aid as governor of Massachusetts, even hiring “revenue maximization” contractors to scour federal programs for every possible penny — and using financial schemes to maximize and then divert the aid from his needy constituents.
In his first budget proposal, Romney promised balancing the budget without tapping reserves, and “without the use of fiscal gimmicks.” However, buried in the details, he suggested tapping reserves such as taking $4 million from the Catastrophic Illness in Children Relief Fund, and he included fiscal gimmicks to maximize and divert federal aid into his general state coffers.
His strategies are akin to tax schemes using offshore bank accounts — but instead of avoiding federal taxes, seeking to pilfer the federal treasury. The Wall Street Journal labeled such financing mechanisms “Medicaid Money Laundering” and a “swindle.”
Medicaid is a matching grant program. If a state with a 50 percent match rate like Massachusetts spends $50 on qualifying services, the federal government will provide an additional $50 so there is $100 total for Medicaid services. The federal match payment is much higher in some states, such as Mississippi where its almost 75 percent.
Unfortunately, some states concocted budget shell games, often with private consultants, providing an illusion of state spending to claim federal matching funds, when no state spending has occurred. As governor of New Hampshire, Judd Gregg developed such a practice labeled “Mediscam.” Gregg taxed hospitals serving the poor, routed the money into an “uncompensated care fund” which he sent right back to the hospitals, and used the round-trip of money to claim federal matching funds. Then, the swindle gets worse, because he routed the federal Medicaid funds into his general coffers rather than for Medicaid services.
Romney’s schemes were similar to Gregg’s. Buried in his 2004 budget, Romney proposed maximizing federal aid by taxing hospitals, shifting the resulting tax payments in and out of an uncompensated care fund, back to hospitals as adjustment payments, and diverting resulting federal Medicaid funds to state general revenue. He also proposed using taxes on nursing homes and pharmacies in his efforts to maximize and divert federal aid.
In such strategies, health care facilities serving the poor are used to claim federal funds to help the poor. But the health care facilities and the poor may get nothing, as the state diverts the federal aid to general coffers — and revenue maximization contractors reap millions in contingency fees. Romney used such private companies to help carryout his strategies.
After a US General Accounting Office report responding to concerns of Republican Senator Charles Grassley, the Romney administration vigorously defended using contingency-fee revenue maximization consultants and revenue practices – that the GAO labeled illusory. The GAO responded that “hospitals should benefit from increased federal reimbursements and Massachusetts’s arrangement appeared to result in lower payments to hospitals, despite increased claims for federal reimbursement.” The Romney administration even defended double (if not quadruple) billing practices “of allowing multiple agencies to bill Medicaid” for “services for the same beneficiary.” The GAO concluded that the Romney administration “did not provide convincing evidence that the [Medicaid] services provided by the four state agencies were unique,” and the Bush administration agreed with the GAO’s conclusions.
The Bush administration implemented regulations trying to reduce such practices, and the Obama administration continues efforts to improve fiscal integrity in the Medicaid program. However, Romney would virtually end federal oversight by block-granting federal Medicaid funds to states.
It’s not hard to imagine how a governor — one that employs complex shell games to find loopholes in federal rules in order to maximize and divert federal aid — would use the federal funds if handed to the state without any federal oversight. The answer to state misuse of federal aid is not to give those states even more discretion to do whatever they wish – but to simplify the claiming process, reduce loopholes allowing the revenue schemes, and improve oversight to ensure Medicaid funds are used as intended.
Romney has undergone dramatic and hard to follow shifts in his apparent views of government aid. Romney2004 proposed cutting healthcare while simultaneously proposing illusory schemes to maximize and divert federal Medicaid funds. Romney2006 changed course with the first nearly universal healthcare plan. Now Romney2012 is turning back to cuts, denouncing federal aid he once schemed to maximize and divert, condemning those who need government aid, and seeking repeal of national health care reform that is nearly identical to the plan he signed into law. And now he proposes giving all the federal money from the Medicaid program to states without federal control.
Romney2004 would have a field day with Romney2012’s plan.
By: Daniel L. Hatcher, Law Professor, University of Baltimore, Published in The Boston Globe, October 12, 2012
“If Facts Spoke For Themselves”: Takeaways On The VP Debate From Paul Ryan’s Home State
The lively October 11 debate between Vice President Joe Biden and the GOP Vice-Presidential candidate, Wisconsin Rep. Paul Ryan, has been widely analyzed and fact-checked. But from the Wisconsin perspective, a few statements made by our fellow cheesehead brought to mind some idioms used widely in his home state.
If You Live In a Glass House, Don’t Throw Stones
“Joe and I are from similar towns. He’s from Scranton, Pennsylvania. I’m from Janesville, Wisconsin.” Ryan then cited Scranton’s ten percent unemployment rate, incorrectly suggesting it was indicative of national trends. “You know what it was the day [Obama and Biden] came in? 8.5 percent. That is happening all around America.”
When Ryan first became a U.S. Representative in 1999, unemployment in Janesville was at 3.8 percent. It is now at 9.2 percent. But nationally and in America’s major cities, unemployment is going down, albeit slowly. Unemployment in Ryan’s hometown is still too high, but the rate has dropped from a peak of 15.6 percent a few months after Obama and Biden took office. The peak was largely attributable to the Janesville General Motors plant closing in 2008 under President George W. Bush.
Fool Me Once, Shame on You; Fool Me Twice, Shame on Me
Ryan pledged during the debate that the Romney-Ryan ticket has a plan for “getting the economy growing at 4 percent, creating 12 million jobs over the next four years.”
The 12 million jobs pledge is one that Romney has been repeating on the campaign trail, with the campaign airing ads in Ryan’s home state promising to create 240,000 jobs in Wisconsin (12 million divided by 50 states). But folks in Wisconsin have reason to doubt these sorts of jobs pledges.
Wisconsin’s current Governor Scott Walker was elected in 2010 with a nearly identical jobs pledge — a promise to create 250,000 jobs by the end of his term in 2014 — and repeated the pledge in May of 2012 during his recall election. But even Walker admits this promise is already broken. Wisconsin’s job growth rates continues to rank among the worst in the nation, behind other states in the region and nationally.
Biden, for his part, did not make a specific promise about jobs numbers, but he did say “we can and we will” get unemployment below 6 percent, a plan that the White House has not backed up with any specifics.
As CMD asked in September, do these folks really think Wisconsinites will fall for it again?
Don’t Look a Gift Horse in the Mouth
In the debate, Rep. Ryan railed against the Obama administration’s stimulus plan and characterized it as a failure. Biden quickly pointed out that Ryan himself had sought stimulus funds for companies in his district.
“I love that, I love that,” Biden responded, laughing. “This is such a bad program and he writes me a letter saying — writes the Department of Energy a letter saying — the reason we need this stimulus, it will create growth and jobs. His words. And now he’s sitting here looking at me.”
Ryan sought $20 million in “green stimulus” for the Wisconsin Energy Conservation Corporation and hundreds of thousands of dollars for the Energy Center of Wisconsin, both of which were granted by the Department of Energy. Ryan defended the letters in the debate by saying “We advocated for constituents who were applying for grants. It’s what we do.”
In one of the letters, Ryan wrote: “I was pleased that the primary objectives of their project will allow residents and businesess in the partner cities to reduce their energy costs, reduce greenhouse gas emissions, and stimulate the local economy by creating new jobs.”
Other businesses in Ryan’s district have also benefitted from stimulus spending. Ruud Lighting in Racine, for example, manufactures LED lights and has expanded and added jobs by winning contracts to supply LED lights to municipalities across the United States, many of which are making the purchases using federal stimulus dollars from the Department of Energy.
Don’t Kill a Goose That Lays Golden Eggs
In his closing statements, Ryan repeated the widely discredited claim that Obamacare is a “government takeover of health care,” a right-wing talking point that CMD’s Senior Fellow on Healthcare Wendell Potter has demonstrated was developed by the private health care industry. “Obamacare,” after all, was developed largely to protect and defend the private insurance industry against those who preferred a government-run health care system, such as those found in Canada and much of Europe.
Romney and Ryan have pledged to repeal “Obamacare” without putting forward a plan to replace it. But in 2010, Rep. Ryan sought Obamacare funding for a community health center in his district.
“The proposed new facility, the Belle City Neighborhood Health Center, will serve both the preventative and comprehensive primary healthcare needs of thousands of new patients of all ages who are currently without healthcare,” Ryan wrote.
Community health centers like this one provide a variety of vital health services to low-income communities, and “Obamacare” provides funding to significantly expand those services, including $9.5 billion in operating costs for existing community health centers and $1.5 billion for constructing new facilities.
Wisconsinites will be talking about these facts and others as they gather around the bubbler this weekend.
By: Brendan Fischer, Center for Media and Democracy, October 12, 2012
“Abhorrent”: Libyan Ambassador’s Death Should Not Be A Political Issue, Says Dad
The father of Christopher Stevens, the U.S. ambassador to Libya who was killed in the attack in Benghazi last month, said his son’s death shouldn’t be politicized in the presidential campaign.
“It would really be abhorrent to make this into a campaign issue,” Jan Stevens, 77, said in a telephone interview from his home in Loomis, California, as he prepares for a memorial service for his son next week.
Mitt Romney, the Republican nominee, has criticized President Barack Obama for not providing adequate security in Libya, saying the administration has left the country exposed to a deadly terrorist attack.
The ambassador’s father, a lawyer, said politicians should await the findings of a formal investigation before making accusations or judgments.
“The security matters are being adequately investigated,” Stevens said. “We don’t pretend to be experts in security. It has to be objectively examined. That’s where it belongs. It does not belong in the campaign arena.” Stevens said he has been getting briefings from the State Department on the progress of the investigation.
The question of whether the embassy attack and the ambassador’s death are being politicized came up on several Sunday morning television talk shows.
Obama campaign strategist David Axelrod said on “Fox News Sunday” that Romney is “working hard to exploit this issue.”
Citing the interview with Stevens’ father, Axelrod said, “we ought to follow ambassador’s family and allow this investigation to run and get to the bottom of it.”
Robert Gibbs, senior adviser to the Obama campaign, also cited the comments by Stevens’ father and said Romney is “playing politics with this issue.”
“We don’t need wing-tip cowboys,” Gibbs said on CNN’s“State of the Union” program. “We don’t need shoot-from- the-hip diplomacy, and when Mitt Romney first responded to what was going on in Libya, his own party called him out for insensitivity.”
Romney campaign adviser Ed Gillespie said on the Fox program that the country needs “honest and accurate answers.” “What we have seen is a constantly shifting story from this administration,” Gillespie said.
“Why wasn’t security there?” Ohio Senator Rob Portman, a Romney supporter, said on ABC’s “This Week” program. “I believe folks deserve an explanation.”
Stevens said that, while he was close to his son, “we weren’t that familiar with the day-to-day activities” he undertook in Libya. On the occasions when his son called home, Stevens said, he didn’t share many details about his work other than to say that “he was very optimistic about the results of the election and the new government.” They last spoke by phone in August and by e-mail days before his son’s death.
Stevens, a registered Democrat, said he isn’t politically active. He declined to say how he’ll vote in the presidential election.
He said his son, who was a career diplomat and had worked for Republican and Democratic presidents, hadn’t expressed concerns to him about security or support from the administration. “He felt very strongly about Secretary Clinton,” Stevens said, referring to Secretary of State Hillary Clinton. “He felt she was an extremely able person.”
As for whether he had the tools and protection he needed for his job, Stevens said of his son: “We didn’t get into that” sort of discussion. “I never heard him say a critical word about the State Department or the administration, or any administration for that matter. He came up through the foreign service, not politics.”
Stevens said neither of the two presidential campaigns reached out to him, and that he is grateful for that. He said Obama telephoned him after his son’s death to express his regrets and talk about identifying the perpetrators who should be brought to justice, and that the conversation was in the context of his presidential duties and not political.
While polls indicate that voters say Obama would do a better job on foreign policy issues, Republicans see an opportunity to cut into that advantage, pointing to surveys showing that voters have grown less satisfied since the Sept. 11 assault in Libya.
Stevens stopped short of directly criticizing either candidate.
“I’m not sure exactly what he’s been saying and not saying, but our position is it would be a real shame if this were politicized,” Stevens said, referring to Romney. “Our concern now is memorializing Chris and remembering his contribution to the country.”
Romney’s current foreign policy position marks a shift in tone from a campaign that has focused almost exclusively on economic issues and jobs.
The Romney team is attempting to link two campaign messages by charging Obama with weakening American interests abroad at the same time as he’s failed to boost the economy back home.
Speaking to voters on Oct. 12 in Richmond, Virginia, Romney chastised Vice President Joe Biden for his defense of the administration’s actions in the Libya attack.
“He’s doubling down on denial, and we need to understand exactly what happened as opposed to just having people brush this aside,” Romney said.
During last week’s vice presidential debate, Biden said the White House wasn’t told of a request for additional security at the mission in Benghazi the month before the incident.
State Department official Eric Nordstrom, who served as a regional security officer in Tripoli until July, told a congressional committee that he was turned down when he requested an extension of a 16-member security support team that was scheduled to leave Libya in August.
Romney hasn’t specified what he would do differently than the administration in Libya. In a speech at the Virginia Military Institute earlier last week, he called for support of Libya’s “efforts to forge a lasting government” and to pursue the “terrorists who attacked our consulate.”
That view is at odds with the position Romney took more than a year ago, when he opposed expanding the intervention in Libya to capture Muammar Qaddafi, calling it “mission creep and mission muddle” in April 2011.
Neither the administration’s initial public report that the attack began with a spontaneous demonstration against an anti- Islamic video clip nor Republican suggestions that it was a planned attack tied to al-Qaeda are supported by U.S. intelligence reports or by accounts of the night provided to a Bloomberg reporter by Benghazi residents.
White House Press Secretary Jay Carney told reporters that “the president wants to get to the bottom of what happened.”
Carney also sought to minimize questions about why the president and other administration officials were slow to publicly acknowledge the role of terrorism in the attack.
“As time went on, additional information became available,” Carney said. “Clearly, we know more today than we did on the Sunday after the attack. But as the process moves forward and more information becomes available, we will be sure to continue consulting with you.”
By: Margaret Taley, Bloomberg, October 14, 2012
“Wrong Again Mitt”: Romney Says People Don’t Die Because They Lack Insurance
In an interview with the Columbus Dispatch in Ohio published Thursday, Mitt Romney repeated a claim that already got him in trouble once this cycle and has reflects an enduring belief among Republicans: that people in the U.S. don’t die because they lack health insurance.
“[Y]ou go to the hospital, you get treated, you get care, and it’s paid for, either by charity, the government or by the hospital,” Romney said. “We don’t have people that become ill, who die in their apartment because they don’t have insurance.”
It’s eerily reminiscent of a statement President George W. Bush made in 2007 that haunted Republicans during the 2008 campaign — “[P]eople have access to health care in America. After all, you just go to an emergency room.”
There’s just one problem: It’s not true.
Numerous studies over the past 10 years conclude that tens of thousands of Americans die each year because they lack insurance.
A 2009 study conducted at Harvard Medical School and Cambridge Health Alliance, and published in the American Journal of Public Health concluded that “[l]ack of health insurance is associated with as many as 44,789 deaths per year in the United States, more than those caused by kidney disease. … The increased risk of death attributable to uninsurance suggests that alternative measures of access to medical care for the uninsured, such as community health centers, do not provide the protection of private health insurance.”
A 2012 report by the health care reform advocacy group Families USA concluded that 26,100 people died prematurely in America in 2010 due to lack of insurance. That report extrapolated from a 2002 Institute of Medicine study — conducted when the uninsurance rate was lower — which concluded that 18,000 people died prematurely because they weren’t covered.
In a 2009 update, the IOM concluded that uninsured patients are at higher risk of mortality or poor health outcomes in the aftermath of both acute medical issues (heart attacks, serious injury, stroke) and chronic ones (cancer, diabetes).
In 2008, the Urban Institute’s Stan Dorn concluded that “[b]ased on the IOM’s methodology and subsequent Census Bureau estimates of insurance coverage, 137,000 people died from 2000 through 2006 because they lacked health insurance, including 22,000 people in 2006. Much subsequent research has continued to confirm the link between insurance and mortality risk described by IOM. In fact, subsequent studies and analysis suggest that, if anything, the IOM methodology may underestimate the number of deaths that result from a lack of insurance coverage.”
Conservatives have attacked these findings and methods and argued that, controlling for health status, there’s no difference in survival probabilities between insured and uninsured people. When the Families USA report came out, Avik Roy, a Romney health adviser, called its findings “statistical hogwash.”
To buttress his argument, he cited a thorough study by Richard Kronick — a University of Rochester health policy expert who served in the Obama administration and was a senior adviser to Bill Clinton during his push for health care reform. His conclusion? “[I]f two people are otherwise similar at baseline … but one is insured and the other uninsured, their likelihood of survival over a 2-16-year follow-up period is nearly identical.”
Further, I show that survival probabilities for the insured and uninsured are similar even among disadvantaged subsets of the population; that there are no differences for long-term uninsured compared with short-term uninsured; that the results are no different when the length of the follow-up period is shortened; and that there are no differences when causes of death are restricted to those causes thought to be amenable to the quality of health care.
However, Kronick conceded that “[g]iven the inherent uncertainties in inferring causality from the results of observational analyses, the results presented here are not able to provide a definitive answer to the question, ‘How many fewer deaths would there be in the United States if all residents were continuously covered by health insurance?’”
In an interview, Urban’s Stan Dorn praised Kronick but defended his and his colleagues’ conclusion.
“I’m aware of Rick’s study and he’s a great researcher. And I guess what I’d say is it’s an outlier,” Dorn said in an interview. “There’s a lot of research that goes beyond what we did, and it’s an outlier.”
Dorn noted that other studies focusing on particular ailments make the link between uninsurance and death quite clear. “We know that women with cervical cancer who are uninsured get their cancer detected later…. We know that people with heart disease don’t take their medicine because they can’t afford it…and sometimes die.”
And as Boston University health economist Austin Frakt noted when he engaged this same controversy in February 2010, “among recent studies in this area the evidence is greater than three-to-one in favor of an insurance-health outcome link, including mortality.”
In 2006, then-Massachusetts governor Romney himself agreed — at least to an extent. Though he did not address the mortality issue specifically, in an April 2006 presentation before the Chamber of Commerce he conceded that uninsured people who seek health care at emergency rooms experience worse outcomes.
“There ought to be enough money to help people get insurance because an insured individual has a better chance of having an excellent medical experience than the one who has not. An insured individual is more likely to go to a primary care physician or a clinic to get evaluated for their conditions and to get early treatment, to get pharmaceutical treatment, as opposed to showing up in the emergency room where the treatment is more expensive and less effective than if they got preventive and primary care.”
By: Brian Beutler, Talking Points Memo, October 12, 2012
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