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Sunday, April 28, 2013

Health Care Reform Articles - April 28, 2013


If this was a pill, you’d do anything to get it

By Ezra Klein, Updated: 

When Ken Coburn has visitors to the cramped offices of Health Quality Partners in Doylestown, Pa., he likes to show them a graph. It’s not his graph, he’s quick to say. Coburn is not the sort to take credit for other’s work. But it’s a graph that explains why he’s doing what he’s doing. It’s a graph he particularly wishes the folks who run Medicare would see, because if they did, then there’s no way they’d be threatening to shut down his program.
The graph shows the U.S. death rate for infectious diseases between 1900 and 1996. The line starts all the way at the top. In 1900, 800 of every 100,000 Americans died from infectious diseases. The top killers were pneumonia, tuberculosis and diarrhea. But the line quickly begins falling. By 1920, fewer than 400 of every 100,000 Americans died from infectious diseases. By 1940, it was less than 200. By 1960, it’s below 100. When’s the last time you heard of an American dying from diarrhea?
“For all the millennia before this in human history,” Coburn says, “it was all about tuberculosis and diarrheal diseases and all the other infectious disease. The idea that anybody lived long enough to be confronting chronic diseases is a new invention. Average life expectancy was 45 years old at the turn of the century. You didn’t have 85-year-olds with chronic diseases.”
With chronic illnesses like diabetes and heart disease you don’t get better, or at least not quickly. They don’t require cures so much as management. Their existence is often proof of medicine’s successes. Three decades ago, cancer typically killed you. Today, many cancers can be fought off for years or even indefinitely. The same is true for AIDS, and acute heart failure and so much else. This, to Coburn, is the core truth, and core problem, of today’s medical system: Its successes have changed the problems, but the health-care system hasn’t kept up.
Kenneth Thorpe, chairman of the health policy and management school at Emory University, estimates that 95 percent of spending in Medicare goes to patients with one or more chronic conditions — with enrollees suffering five or more chronic conditions accounting for 78 percent of its spending. “This is the Willie Sutton rule,” he says. “If 80 percent of the spending is going to patients with five or more conditions, that’s where our health-care system needs to go.”
Health Quality Partners is all about going there. The program enrolls Medicare patients with at least one chronic illness and one hospitalization in the past year. It then sends a trained nurse to see them every week, or every month, whether they’re healthy or sick. It sounds simple and, in a way, it is. But simple things can be revolutionary.


Doctors Denounce Cancer Drug Prices of $100,000 a Year




With the cost of some lifesaving cancer drugs exceeding $100,000 a year, more than 100 influential cancer specialists from around the world have taken the unusual step of banding together in hopes of persuading some leading pharmaceutical companies to bring prices down.
Prices for cancer drugs have been part of the debate over health care costs for several years — and recently led to a public protest from doctors at a major cancer center in New York. But the decision by so many specialists, from more than 15 countries on five continents, to join the effort is a sign that doctors, who are on the front lines of caring for patients, are now taking a more active role in resisting high prices. In this case, some of the specialists even include researchers with close ties to the pharmaceutical industry.
The doctors and researchers, who specialize in the potentially deadly blood cancer known as chronic myeloid leukemia, contend in a commentary published online by a medical journal Thursday that the prices of drugs used to treat that disease are astronomical, unsustainable and perhaps even immoral.
They suggested that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking up the prices of essential goods after a natural disaster.
“Advocating for lower drug prices is a necessity to save the lives of patients” who cannot afford the medicines, they wrote in Blood, the journal of the American Society of Hematology.
While noting that the cost of drugs for many other cancers were just as high, the doctors focused on what they know best — the medicines for chronic myeloid leukemia, like Gleevec, which is enormously profitable for Novartis. Among the critics is Dr. Brian Druker, who was the main academic developer of Gleevec and had to prod Novartis to bring it to market.
Novartis argues that few patients actually pay the full cost of the drug and that prices reflect the high cost of research and the value of a drug to patients.
Gleevec entered the market in 2001 at a price of about $30,000 a year in the United States, the doctors wrote. Since then, the price has tripled, it said, even as Gleevec has faced competition from five newer drugs. And those drugs are even more expensive.
The prices have been the subject of intense debate elsewhere as well. The Supreme Court in India ruled recently that the drug could not be patented, clearing the way for use of far less expensive generic alternatives.
Some of the doctors who signed on to the commentary said they were inspired by physicians at the Memorial Sloan-Kettering Cancer Center in New York, who last fall refused to use a new colon cancer drug, Zaltrap, because it was twice as expensive as another drug without being better.
After those doctors publicized their objections in an Op-Ed article in The New York Times, Sanofi, which markets Zaltrap, effectively cut the price in half.
What impact the new commentary will have remains to be seen. The authors, however, call merely for a dialogue on pricing to begin.

U.S. Sues Novartis Again, Accusing It of Kickbacks




The United States government on Friday announced its second civil fraud lawsuit against the Swiss drug maker Novartis in four days, accusing a unit of the company of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.
The authorities said that for a decade, the company lavished healthy speaking fees and “opulent” meals, including a nearly $10,000 dinner for three at the restaurant Nobu, to induce doctors to prescribe its drugs.
They said this led to the Medicare and Medicaid programs’ paying millions of dollars in reimbursements based on kickback-tainted claims for medication like thehypertension drugs Lotrel and Valturna and the diabetes drug Starlix.
The charges are described in a whistle-blower lawsuit first filed against Novartis Pharmaceuticals by a former sales representative in January 2011 and which the federal government has now joined.
Twenty-seven states, the District of Columbia and Chicago and New York are also plaintiffs in the lawsuit, which seeks triple damages under the federal False Claims Act.
“Novartis corrupted the prescription drug dispensing process,” Preet Bharara, the United States attorney in Manhattan, said in a statement. “For its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid and other federal health care programs were left holding the bag.”
On Tuesday, the government accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts.
http://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?hpw&pagewanted=print


Another Alleged Drug Kickback Scheme



Two federal lawsuits charging a prominent drug company with making fraudulent kickbacks to promote sales of its drugs raise disturbing questions about how to control fraudulent behavior in the pharmaceutical industry, behavior that appears to be on the rise. The company is Novartis Pharmaceuticals, the American subsidiary of a Swiss-based multinational. Novartis denies any wrongdoing and vows to defend itself in court.
Less than three years ago, Novartis settled criminal and civil investigations into whether it had illegally promoted drugs to health care professionals for uses not approved by the Food and Drug Administration. The company was accused of providing illegal kickbacks to doctors through such mechanisms as entertainment, travel, and appointment to advisory boards or speaker programs. It paid $422.5 million to settle the case and signed a “corporate integrity agreement” to ensure that its promotional functions would comply with a federal anti-kickback statute.
Last week Preet Bharara, the United States attorney for the Southern District of New York, announced the filing of a lawsuit accusing the company of providing even more blatant kickbacks to pharmacies to generate sales of one of its better-selling drugs. The suit charged that Novartis provided illegal rebates and discounts to 20 or more influential pharmacies based on their success in persuading institutions and doctors to switch patients from other drugs to Myfortic, an immune suppressant used to prevent rejection of kidney transplants. (If prosecutors want to send an even stronger message, they should also pursue the corrupt pharmacies, which are suspected of pocketing tens or hundreds of thousands of dollars in illegal kickbacks.)
The federal prosecutors also filed a second suit, charging that Novartis Pharmaceuticals made illegal payments to physicians in the form of honorariums and other benefits to induce them to write prescriptions for various other drugs made by the company. These sound like exactly the kinds of payments that Novartis pledged not to make in the settlement three years ago.

Democratic Senators Tell White House of Concerns About Health Care Law Rollout



WASHINGTON — Democratic senators, at a caucus meeting with White House officials, expressed concerns on Thursday about how the Obama administration was carrying out the health care law they adopted three years ago.
Democrats in both houses of Congress said some members of their party were getting nervous that they could pay a political price if the rollout of the law was messy or if premiums went up significantly.
President Obama’s new chief of staff, Denis R. McDonough, fielded questions on the issue for more than an hour at a lunch with Democratic senators.
Senator Jeanne Shaheen, Democrat of New Hampshire, who is up for re-election next year, said, “We are hearing from a lot of small businesses in New Hampshire that do not know how to comply with the law.”
In addition, Mrs. Shaheen said, “restaurants that employ people for about 30 hours a week are trying to figure out whether it would be in their interest to reduce the hours” of those workers, so the restaurants could avoid the law’s requirement to offer health coverage to full-time employees.
The White House officials “acknowledged that these are real concerns, and that we’ve got to do more to address them,” Mrs. Shaheen said.
Senator Tom Harkin, Democrat of Iowa and chairman of the appropriations subcommittee on health care, said he was extremely upset with Mr. Obama’s decision to take money from public health prevention programs and use it to publicize the new law, which creates insurance marketplaces in every state.
“I am greatly disappointed — beyond upset — that the administration chose to help pay for the Affordable Care Act in fiscal year 2013 by raiding the Public Health and Prevention Fund,” Mr. Harkin said.
The administration said it had transferred $332 million from the prevention fund to pay for “education and outreach” activities publicizing the new insurance markets, or exchanges.
To express his displeasure, Mr. Harkin has blocked Senate action on Mr. Obama’s nominee to be administrator of the Centers for Medicare and Medicaid Services, Marilyn B. Tavenner. By putting a “hold” on the nomination, aides said, Mr. Harkin hopes to draw the White House into negotiations on the future of the prevention fund, which he has championed.
At Congressional hearings this week, Kathleen Sebelius, the secretary of health and human services, said it was necessary to tap the prevention fund because Congress had refused to provide money requested by the president for outreach and education activities.

Maine Democrats offer deal on debt to hospitals

Gov. LePage blasts the proposal, which links repayment of the debt to an expansion of Medicaid.

By Steve Mistler smistler@pressherald.com
Staff Writer
AUGUSTA – The Legislature's Democratic leaders have told Gov. Paul LePage that they will pass his plan to pay back Maine's hospitals but they want it directly linked to the state's participation in a federal program to expand health care coverage for low-income Mainers.
LePage blasted the proposal Friday, saying Democrats had "reneged" on their agreement to pay the state's 39 hospitals for overdue Medicaid reimbursements.
House Speaker Mark Eves, D-North Berwick, and Senate President Justin Alfond, D-Portland, told the governor their plan Thursday during a closed-door meeting in the governor's Cabinet Room. It marks a shift in the debate over paying back more than $484 million to the hospitals and a separate policy to expand Medicaid to about 55,000 Mainers. 
The two proposals have been linked because Maine's hospitals, which are influential in state politics, support both. But the Democrats' proposal is their first attempt to directly tie LePage's hospital payback plan to his acceptance of federal dollars to expand Medicaid.
It's also one of the first attempts by Democratic leaders to assert themselves by leveraging their legislative majority to advance one of their primary policy initiatives. 

Why is Maine 5th in US for health care spending?

Posted April 26, 2013, at 2:51 p.m.
AUGUSTA, Maine — The state’s health care costs per person exceed the national average and continue to rise at a faster-than-average rate. But while lawmakers often stress the need to rein in health care spending, they have not settled on a long-term strategy to do so.
Discord among Democrats and Republicans over crafting that strategy emerged on the House floor Wednesday when legislators debated a bill that would form a state Commission on Health Care Cost and Quality and charge it with developing a plan for cutting costs and improving outcomes in Maine’s health care system.
Democrats said the legislation, LD 230, was needed to focus health care reforms in the state on a common goal. Republicans, meanwhile, said the commission would duplicate work already underway at the Department of Health and Human Services — and at a significant cost.
The bill garnered initial approval in the Democratically controlled House with a 90-57 party-line vote. While it sparked partisan tension, members of both parties acknowledged Maine needs a coordinated plan if it stands a chance of improving the health of its population and controlling health care costs.

Above-average costs, growth

In 1993, spending on health care in Maine totaled $3.6 billion, according to the federal Centers for Medicare and Medicaid Services. By 2009, that figure had risen 214 percent, to $11.2 billion. Total property taxes in Maine rose 103 percent during that period, in comparison.
Health care spending today accounts for more than a fifth of Maine’s economy — 22.4 percent in 2009, according to the Maine Development Foundation. And Maine Department of Labor statisticsshow the health care and social assistance sector accounts for one in five jobs in the state.
The underlying figures portend affordability problems for the Maine businesses and residents who pay for health insurance. They also portend problems for the state budget, which needs to fund a Medicaid program that covers 27 percent of the population and is sensitive to spikes in the cost of care.
Maine ranked fifth nationally in 2009 for per-capita spending on health care, according to the Kaiser Family Foundation. The Pine Tree State spent $8,521 per person, 25 percent more than the national average of $6,815.
And Maine’s health care costs keep rising. According to the Centers for Medicare and Medicaid Services, costs in the state rose an average of 7.4 percent annually between 1991 and 2009, compared with 6.5 percent nationally.



Our Feel-Good War on Breast Cancer



I used to believe that a mammogram saved my life. I even wrote that in the pages of this magazine. It was 1996, and I had just turned 35 when my doctor sent me for an initial screening — a relatively common practice at the time — that would serve as a base line when I began annual mammograms at 40. I had no family history of breast cancer, no particular risk factors for the disease.
So when the radiologist found an odd, bicycle-spoke-like pattern on the film — not even a lump — and sent me for a biopsy, I wasn’t worried. After all, who got breast cancer at 35?
It turns out I did. Recalling the fear, confusion, anger and grief of that time is still painful. My only solace was that the system worked precisely as it should: the mammogram caught my tumor early, and I was treated with a lumpectomy and six weeks of radiation; I was going to survive.
By coincidence, just a week after my diagnosis, a panel convened by the National Institutes of Health made headlines when it declined to recommend universal screening for women in their 40s; evidence simply didn’t show it significantly decreased breast-cancer deaths in that age group. What’s more, because of their denser breast tissue, younger women were subject to disproportionate false positives — leading to unnecessary biopsies and worry — as well as false negatives, in which cancer was missed entirely.
Those conclusions hit me like a sucker punch. “I am the person whose life is officially not worth saving,” I wrote angrily. When the American Cancer Society as well as the newer Susan G. Komen foundation rejected the panel’s findings, saying mammography was still the best tool to decrease breast-cancer mortality, friends across the country called to congratulate me as if I’d scored a personal victory. I considered myself a loud-and-proud example of the benefits of early detection.
Sixteen years later, my thinking has changed. As study after study revealed the limits of screening — and the dangers of overtreatment — a thought niggled at my consciousness. How much had my mammogram really mattered? Would the outcome have been the same had I bumped into the cancer on my own years later? It’s hard to argue with a good result. After all, I am alive and grateful to be here. But I’ve watched friends whose breast cancers were detected “early” die anyway. I’ve sweated out what blessedly turned out to be false alarms with many others.
Recently, a survey of three decades of screening published in November in The New England Journal of Medicine found that mammography’s impact is decidedly mixed: it does reduce, by a small percentage, the number of women who are told they have late-stage cancer, but it is far more likely to result in overdiagnosis and unnecessary treatment, including surgery, weeks of radiation and potentially toxic drugs. And yet, mammography remains an unquestioned pillar of the pink-ribbon awareness movement. Just about everywhere I go — the supermarket, the dry cleaner, the gym, the gas pump, the movie theater, the airport, the florist, the bank, the mall — I see posters proclaiming that “early detection is the best protection” and “mammograms save lives.” But how many lives, exactly, are being “saved,” under what circumstances and at what cost? Raising the public profile of breast cancer, a disease once spoken of only in whispers, was at one time critically important, as was emphasizing the benefits of screening. But there are unintended consequences to ever-greater “awareness” — and they, too, affect women’s health.

Diagnosing the Wrong Deficit



IN the spring of 2010, a new patient came to see me to find out if he had attention-deficit hyperactivity disorder. He had all the classic symptoms: procrastination, forgetfulness, a propensity to lose things and, of course, the inability to pay attention consistently. But one thing was unusual. His symptoms had started only two years earlier, when he was 31.
Though I treat a lot of adults for attention-deficit hyperactivity disorder, the presentation of this case was a violation of an important diagnostic criterion: symptoms must date back to childhood. It turned out he first started having these problems the month he began his most recent job, one that required him to rise at 5 a.m., despite the fact that he was a night owl.
The patient didn’t have A.D.H.D., I realized, but a chronic sleep deficit. I suggested some techniques to help him fall asleep at night, like relaxing for 90 minutes before getting in bed at 10 p.m. If necessary, he could take a small amount of melatonin. When he returned to see me two weeks later, his symptoms were almost gone. I suggested he call if they recurred. I never heard from him again.
Many theories are thrown around to explain the rise in the diagnosis and treatment of A.D.H.D. in children and adults. According to the Centers for Disease Control and Prevention, 11 percent of school-age children have now received a diagnosis of the condition. I don’t doubt that many people do, in fact, have A.D.H.D.; I regularly diagnose and treat it in adults. But what if a substantial proportion of cases are really sleep disorders in disguise?
For some people — especially children — sleep deprivation does not necessarily cause lethargy; instead they become hyperactive and unfocused. Researchers and reporters are increasingly seeing connections between dysfunctional sleep and what looks like A.D.H.D., but those links are taking a long time to be understood by parents and doctors.
We all get less sleep than we used to. The number of adults who reported sleeping fewer than seven hours each night went from some 2 percent in 1960 to more than 35 percent in 2011. Sleep is even more crucial for children, who need delta sleep — the deep, rejuvenating, slow-wave kind — for proper growth and development. Yet today’s youngsters sleep more than an hour less than they did a hundred years ago. And for all ages, contemporary daytime activities — marked by nonstop 14-hour schedules and inescapable melatonin-inhibiting iDevices — often impair sleep. It might just be a coincidence, but this sleep-restricting lifestyle began getting more extreme in the 1990s, the decade with the explosion in A.D.H.D. diagnoses.

LePage says Democrats ‘jumping the gun’ on Medicaid expansion

Posted April 27, 2013, at 6:53 p.m.
BANGOR, Maine — Democrats who now want to expand the Medicaid program under the federal Affordable Care Act are “jumping the gun” because not enough is known yet about the program, Gov. Paul LePage said Saturday.
“[Health and Human Services] Commissioner [Mary] Mayhew is going to Washington next week specifically to talk about the expansion,” LePage said at the Four Points Sheraton Hotel at Bangor International Airport. “Why would we jump the gun and not work with the federal government before we expand it?”
The governor and his wife, Ann LePage, were in Bangor on Saturday to attend the state convention of the Maine chapter of Disabled Veterans of America.
At an impromptu press conference in the walkway between the terminal and the hotel, the governor said that he wanted some assurances from officials in Washington, D.C., “that in three years they aren’t going to start reducing reimbursement.”
LePage was reacting to what he called “an ultimatum” delivered Thursday by Democratic legislative leaders. They proposed a deal that would tie the payback of Maine’s $484 million hospital debt to the expansion of Medicaid, according to a previously published report.
House Speaker Mark Eves, D-North Berwick, has said Democrats want to tie the debt payback to health care system reforms that could control costs in the long run.
“Democrats are going to repay the hospitals. It’s a top priority of ours,” he said Thursday. “As we make that final payment on our hospital debt, we’re also going to do things that address cost drivers in our health care system.”


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