Showing posts with label pharmaceutical companies. Show all posts
Showing posts with label pharmaceutical companies. Show all posts

Friday, February 9, 2018

Congress just passed a massive budget deal — and it includes some huge changes for Americans' healthcare


  • Congress early Friday morning passed a massive budget deal aimed to fix the US government's cycle of short-term funding bills after a brief shutdown.
  • The plan includes funding for the National Institutes of Health, the opioid crisis, among other health initiatives, totaling almost $20 billion.
  • It also extends the Children's Health Insurance Program for 10 years and closes the Medicare "donut hole" a year earlier than anticipated. 


Congress passed a bipartisan plan on Friday to end a brief government shutdown. 

That plan introduced significant funding and changes for healthcare initiatives and agencies, including funding for the National Institutes of Health, the opioid crisis, among other health initiatives, totaling almost $20 billion.

The Senate and House voted on the deal late Thursday and early Friday morning. Many House members had expressed concerns about the plan, threatening its path forward.

"Ultimately, neither side got everything it wanted in this agreement, but we reached a bipartisan compromise that puts the safety and well-being of the American people first," House Speaker Paul Ryan said.
 
Some of its healthcare-related initiatives include:
  • An additional $2 billion for the National Institutes of Health. 
  • $6 billion over the next two years to combat the opioid crisis, a big increase from the funding set aside by naming the crisis a "public health emergency.
  • $4 billion for VA hospital and clinic improvements.  
  • A two-year reauthorization of community health centers, with $7 billion in total funding. That would help reinstate the funding the centers — which serve more than 25 million Americans — lost when a key fund expired in September 2017.  
  • $495 million for National Health Service Corps, an organization within the Department of Health and Human Service that helps medical professionals pay for their medical education. 
  • $363 million for teaching health centers.
The plan also includes a few changes to the healthcare system. 
  • It closes the donut hole in Medicare, an aspect of Medicare's prescription drug coverage that left seniors on the hook for a certain amount of prescription drug costs before hitting a yearly limit. The plan closes that hole a year earlier than anticipated, much to the dismay of pharma companies that are now have to bear more of the cost, Axios reports.  
  • It would extend the Children's Health Insurance Program for 10 years. The latest stopgap bill only extended the program for 6 years. 
source

Friday, January 19, 2018

Fed Up With Drug Companies, Hospitals Decide to Start Their Own

A group of large hospital systems plans to create a nonprofit generic drug company to battle shortages and high prices.

For years, hospital executives have expressed frustration when essential drugs like heart medicines have become scarce, or when prices have skyrocketed because investors manipulated the market.
Now, some of the country’s largest hospital systems are taking an aggressive step to combat the problem: They plan to go into the drug business themselves, in a move that appears to be the first on this scale.

“This is a shot across the bow of the bad guys,” said Dr. Marc Harrison, the chief executive of Intermountain Healthcare, the nonprofit Salt Lake City hospital group that is spearheading the effort. “We are not going to lay down. We are going to go ahead and try and fix it.”

While Intermountain executives would not name the drugs they intend to make, hospitals have long experienced shortages of drugs like morphine or encountered sudden price increases for old, off-patent products like the heart medicine Nitropress. Hospitals have also come under criticism for overcharging for their services, including for some drugs.

Several major hospital systems, including Ascension, a Catholic system that is the nation’s largest nonprofit hospital group, plan to form a new nonprofit company, that will provide a number of generic drugs to the hospitals. The Department of Veterans Affairs is also expressing interest in participating.

In all, about 300 hospitals are now included in the group. Other hospitals are expected to join.
Dr. Harrison said they planned to focus only on certain drugs. “There are individual places where there are problems,” he said. “We are not indicting an entire industry.”

Dr. Kevin A. Schulman, a professor of medicine at the Duke University School of Medicine who has studied the generic drug market and is advising the effort, said: “If they all agree to buy enough to sustain this effort, you will have a huge threat to people that are trying to manipulate the generic drug market. They will want to think twice.”
The idea is to directly challenge the host of industry players who have capitalized on certain markets, buying up monopolies of old, off-patent drugs and then sharply raising prices, stoking public outrage and prompting a series of Congressional hearings and federal investigations. The most notorious example is of Martin Shkreli, the former hedge fund manager who raised the price of a decades-old drug, Daraprim, to $750 a tablet in 2015, from $13.50.

Hospitals have also struggled to deal with shortages of hundreds of vital drugs over the past decade, ranging from injectable morphine to sodium bicarbonate (the medical form of baking soda), shortfalls that are exacerbated when only one or two manufacturers make the product.

“We’re seeing an acceleration of both shortages and escalation of prices,” said Dr. Richard Gilfillan, the chief executive of Trinity Health, a large Catholic system that operates in nearly two dozen states and is part of the group. “There’s not been any effective push back on either of these.”

Intermountain executives would not discuss many details of the project, citing fears that competitors could shut them out of the market by quickly dropping the price of the drugs in question, then raising them again later. They said they would focus on drugs whose prices have risen sharply or that have been in short supply.

“We’re going to have to hold that very close to our vest,” Dr. Harrison said. The company will either rely on third-party manufacturers or decide to make the drugs themselves.

The new company will initially focus on selling to hospitals, but officials said they may eventually expand to offer the products more broadly.

Dr. Carolyn Clancy, the executive in charge of the Veterans Health Administration, said its pharmacy experts have consulted with the other systems about the project and is now working out the details of its possible involvement. “Our strong interest here is minimizing the impact of any shortages of generic drugs,” she said. While she said the agency is able to negotiate good prices for veterans, “we don’t necessarily control supply” and have experienced many of the same shortages, including the recent lack of saline fluids, as the other health groups.

“We are constantly scanning the horizon and constantly attentive to interruptions of supply chains of medicines,” she said.

In addition to Daraprim, several old, off-patent drugs have seen sharp price increases over the past several years. In 2015, Valeant Pharmaceuticals International became a Wall Street darling after it sold investors on its business model of buying up old drugs, then raising the prices precipitously. That year, it sharply raised the prices of two heart drugs, Nitropress and Isuprel, adding millions to hospitals’ drug bills almost overnight. Valeant’s practices led to a series of investigations and Congressional hearings as well as a shake-up of the company’s leadership.

Representatives for the generic drug industry have noted that many of the most high-profile cases have involved old, off-patent drugs for which there has been no generic competition.
The trade group for generic manufacturers, the Association for Accessible Medicines, said its members generally welcome competition. “The whole generic industry is premised on competition, and that competition brings dramatic savings for patients,” said Allen Goldberg, a spokesman for the group.
But generic drug makers have also come under scrutiny.

The hike in the price of doxycycline hyclate, an antibiotic, which increased to $3.65 a pill in 2013 from 5.6 cents in 2012, led to a congressional investigation as well as state and federal price-fixing inquiries into some of the industry’s biggest players. Last fall, a coalition of state attorneys general broadened a lawsuit over price fixing, accusing 18 companies of engaging in illegal practices involving 15 drugs.

Anthony R. Tersigni, the chief executive of Ascension, said he and other hospital executives felt they had little choice but to try to solve the problem themselves. “We took the position collectively rather than waiting and hoping for the generic drug companies to address it,” he said. “We have to address it head on.”

Intermountain executives said that they would seek approval to manufacture the products from the Food and Drug Administration, which has vowed to give priority to companies that want to make generics in markets for which there is little competition.

The project boasts a high-profile list of advisers, ranging from Bob Kerrey, the former Democratic senator of Nebraska, to Dr. Donald Berwick, a former administrator for the Centers of Medicare and Medicaid Services, as well as two former executives with Amgen, the drug manufacturer.
Erin Fox, a drug shortage expert at the University of Utah, said the idea of creating a nonprofit drug company is promising. “I think anything that increases the number of suppliers will help,” she said. She added that the trick will be in selecting the right third-party manufacturer to ensure good quality.

source

Tuesday, July 5, 2016

Study: 1 free meal can sway doctor's prescription drug choice

As little as one free meal from a drug company can influence which medicines doctors prescribe for Medicare patients.

That's according to a study using Medicare records and recently released data from the health care law's Open Payments program.
The study highlights the subtle ways doctors may feel inclined to prescribe a drug after receiving just a small gift, even if the drug is more costly for patients and their insurance plans, the study authors said.

An estimated $73 billion yearly could be saved if equivalent generics were prescribed instead of brand-name drugs.

The researchers say the bottom line for patients is to always ask if there's a generic that's just as good.

The results were published in the journal JAMA Internal Medicine.

source

Thursday, April 21, 2016

NFP Hospitals Bolster Financials, For-profits Confront Debt Issues

The improving economy and the PPACA are not the only reasons why not-for-profit hospitals are doing better than three years ago, says a senior analyst at Moody's Investors Service.

Financial profiles at not-for-profit hospitals have strengthened over the past three years, thanks in large part to the recovering economy and the Patient Protection and Affordable Care Act, Moody's Investors Service says.

"Stronger operating performance is the result of significant gains in the number of people with insurance, growing patient volumes, and sizeable reductions in bad debt expense. The Affordable Care Act increased insurance coverage in states that expanded Medicaid coverage, contributing to lower bad debt expense," Moody's says in its April Healthcare Quarterly newsletter. "The improving economy, related job gains, and stronger patient volumes also contributed to the sector's stronger performance."

Dan Steingart, a senior analyst Moody's, says the improving economy and the ACA are not the only reasons why not-for-profit hospitals are doing better than three years ago.

"I don't want to give the wrong impression that they haven't been working on their own, because they have," he says. "On the expense side hospitals have been working for several years to take a lot of costs out of the system, but there is a lot more work that can and will be done."

"Those hospitals that have installed electronic medical records systems and have them up and running do realize some incremental savings, but that's sort of a small, sexy area," he says. "There are a lot of nuts-and-bolts, blocking-and-tackling around supply costs, along with productivity. Reducing excess layers of middle management has been a popular area."

The productivity improvements include ensuring that providers work at the top of their licenses, and that the administrative bloating that often comes with mergers and acquisitions is addressed.
"Over the past few years there was slower wage growth, and salaries and benefits are the number one line-item for hospitals," Steingart says.

The improved finances come as hospitals contend with medical inflation, especially around pharmaceuticals. "It's been growing rapidly," Steingart says. "That's a big challenge because after labor, supplies, and drug expenses are a big portion of supplies. [Drugs are] the number two expense for hospitals."

The Effects of M&A
 
Although mergers and acquisitions in the not-for-profit hospital sector have increased over the past few years, Steingart says it's "a notoriously hard thing to measure" how these consolidations have affected hospitals' financial profiles.

"M&A in the not-for-profit sector ranges from large systems acquiring a much smaller community hospital to two larger hospital systems coming together," he says. "I wouldn't say you're seeing savings from M&A, but that is not because it's not necessarily there. It's just much harder to measure because you don't have these big deals that you can point to. You have a lot of drips and drabs in M&A."

"The other side of it, there was a big run up in financial performance in the past two years and that is due to a lot of other factors, the economy, the ACA and the hospitals' own cost-saving initiatives. To attribute that to M&A wouldn't be fair," he says.

The bottom line, Steingart says, is that the improved financial profiles for not-for-profit hospitals means they'll be better positioned to adjust to looming value-based and population health payment models.

Higher Debts Weaken For-Profit Profile

The financial profile for much of the for-profit hospital sector has weakened over the past three years because of higher debt burdens brought on by a spate of acquisitions, Moody's says. However, the debt burden does not affect all for-profits equally, and Moody's says the outlook is expected to improve in the coming year as for-profits look to reduce debt.

"There was definitely a load-up on debt through M&As, in part due to the fact that credit markets were readily available to them," says Dean J. Diaz, a senior vice president with Moody's Corporate Finance Group. "It is nothing that was surprising given the level of M&A activity we've seen of late. It's a period in the cycle and very definitely a consolidation in the sector."

According to Moody's, the for-profit sector's "median debt/EBITDA increased to 5.2x at year end 2015 from 4.7x in 2012, as consolidating companies failed to effectively reduce leverage as much as we had expected.  However, we expect that modest deleveraging over the next year will improve the sector's financial flexibility."

The biggest drivers were Tenet Healthcare Corporation's acquisition of Vanguard Health Systems, Inc., in October 2013 and Community Health System's acquisition of Health Management Associates, Inc., in January 2014.

"The rationale for both of these transactions included the desire to increase and leverage scale to combat pressure on reimbursement rates," Moody's says. "Each company's debt/EBITDA increased to close to 6.0x as a result of these transactions. However, we had expected leverage to return to closer to 5.0x through a combination of debt repayment and EBITDA growth resulting from the realization of significant synergies."

That didn't happen. With CHS, leverage remains high owing to weak volumes.

"Many of the initiatives to grow those margins have taken much longer to take hold. While we expect to see improvement at the HMA facilities during 2016, Community's leverage will now remain high into 2017," Moody's says.

Tenet reduced its leverage but then re-levered in 2015 to acquire a majority interest in United Surgical Partners International.

"For-profit operators will continue to invest in outpatient services," Moody's says. "Volume growth at these facilities will outpace inpatient admissions as commercial payers shift patients to lower cost settings. Outpatient services also require much less in capital expenditures to maintain."

source

Wednesday, June 3, 2015

Wendell Potter: Let’s stop buying party line from insurers, drug companies

Americans spend more per capita on health care than people anywhere else in the world, yet outcomes in every other developed country are better on almost every measure, from infant mortality to life expectancy.

A big reason for that is our collective gullibility. We continue to believe what many politicians tell us, despite evidence to the contrary: that we have the best health care system in the world.

Similarly, we continue to be persuaded by insurance companies that they’re essential to the system and better than any government program could possibly be at controlling health care costs.

And we are still buying the pharmaceutical industry’s argument that if Americans don’t keep paying more for prescriptions than anyone else on the planet, drug companies—which have gargantuan profit margins­­—won’t be able to keep developing the drugs we need.

To understand how foolish we are, let’s consider the war of words that recently erupted between health insurers and drug companies.First, though, let’s take a look at a new study that compares how much Americans pay for prescription medication compared to what folks in a few other industrialized countries pay.
The study, released last week by the Kaiser Permanente Institute for Health Policy, showed that pharmaceutical spending in the U.S. per capita had reached $1,010 in 2012. The next highest spender was Germany at $668 per capita. Australia came in at $558.

Am I the only one who finds it more than a little upsetting that the Germans spend 66 percent of what we spend for drugs and the Aussies spend just 55 percent?

As the Kaiser researchers point out, those countries’ citizens get a much better deal on their meds because their federal governments have policies in place to regulate drug prices. And those nations are not alone. Every other country in the developed world has instituted some kind of price control mechanism. Except, of course, the United States.

Kaiser’s numbers are consistent with those from a 2013 analysis by the 34-member Organization for Economic Cooperation and Development (OECD), which showed that Americans spend 40 percent more on drugs than the next highest spender, Canada.

As PBS pointed out last year in a report on drug prices around the world, government agencies in other countries set limits on how much they (and their citizens) will pay drug makers for their various products.

“By contrast,” as PBS further pointed out, “in the U.S., insurers typically accept the price set by the makers for each drug, especially when there is no competition in a therapeutic area, and then cover the cost with high copayments.” (Emphasis mine.)

PBS nailed it. American insurance companies are essentially powerless when it comes to negotiating prices with Big Pharma, just as they are becoming increasingly powerless in controlling the cost of hospital care and physician services. The way insurers continue to make money is not by doing a good job for their customers but by constantly shifting more of the cost of care to those customers.

If we were paying close enough attention to what insurers were saying during the health care reform debate, we would have realized that they are, for all practical purposes, impotent when it comes to holding down costs. All we had to do was read between the lines.

One of the insurers’ consistent talking points was that instead of putting them in the crosshairs, policymakers should instead focus on “the real drivers of health care costs.” Those “real drivers,” according to insurance company executives, are the companies and people who actually provide most of the care we need: hospitals, doctors and pharmaceutical companies.

The industry’s impotence was on display yet again last year when the drugmaker Gilead slapped a $1,000 per-pill price tag on its new hepatitis C medicine.

“Is this ‘whatever you can get away with’ pricing here?” America’s Health Insurance Plans’ then-CEO, Karen Ignagni, asked during a health care conference.

The answer: yes. Drug companies can get away with it because private insurance companies can’t stop them. And, with the exception of the Veteran’s Administration and Medicaid programs, neither can the U.S. government. In fact, the pharmaceutical industry was able to persuade lawmakers to make it illegal for the government to negotiate with drug companies when they enacted the Medicare drug benefit in 2003.

It’s telling that, in response to Ignagni’s rhetorical question, a pharmaceutical industry spokesman said, almost mockingly, that insurers should do more to control health care costs.

As for Big Pharma’s claim that Americans must pay more to keep their R&D departments humming, which we seem to have bought hook, line and sinker, the Kaiser researchers, like many others before them, suggested we’re being duped.

“There is evidence that companies overestimate the amount they actually spend,” they wrote, citing a 2011 analysis that found the median R&D costs for producing a new drug was $43 million, which is just 5 percent of the $802 million figure the industry routinely cites.

Maybe the question we should be asking is, how much longer can we afford to be so gullible?

source

Wednesday, October 8, 2014

Obamacare Is Making a Difference, But Here's What We Must Tackle Next

Wendell Potter

Although there is no shortage of critics of the Affordable Care Act -- on the far left as well as the right -- it's hard to dispute that the law has benefited millions of Americans. And not just those who have become newly insured over the past year.

President Barack Obama cited some of the impressive statistics last Thursday, the day after the one-year anniversary of the turbulent debut of the Obamacare-created online health insurance exchanges.

"In just the last year, we've reduced the share of uninsured Americans by 26 percent," he said. "That means one in four uninsured Americans -- about 10 million people -- have gained the financial security of health insurance in less than one year."

Approximately 8 million people were finally able to sign up for coverage on the exchanges after the many technical problems were fixed. Many others were able to enroll in health plans on private exchanges or by working directly with an insurance company or agent. As a consequence, the rate of uninsured Americans dropped from 21 percent in September 2013 to 16.3 percent this past April.

Even though open enrollment for the Obamacare exchanges ended in April, people have still been joining the ranks of the insured since then. In fact, the Congressional Budget Office estimates that the number of newly insured Americans will grow to 12 million by the end of this year.

A significant percentage of those folks were not able to find affordable coverage in the past, and many were not able to buy health insurance at any price because of insurance industry business practices that were outlawed by the ACA. Before Obamacare, insurance companies were able to declare you "uninsurable" if you had a preexisting condition, even conditions you might have been born with.

During the months that health care reform was being debated in Washington, I met many young people who told me they had not been able to buy an insurance policy because of congenital heart defects and other conditions they had had since birth.

Now they can.

That provision and other parts of Obamacare that force insurance companies to be more consumer-friendly benefit all of us, but those sections of the law are rarely mentioned these days, probably because many of them went into effect long before the exchanges were up and running. Here's a partial list:

Insurers can no longer "rescind" our policies when we get sick just to avoid paying our medical expenses;
They must allow our children to stay on our policies until they turn 26 if they can't find jobs that offer coverage;

They can't devote more than 20 percent of our premium dollars to overhead and profits;

They can no longer charge women more than men; and

They can't charge older folks more than three times as much as they charge young people for the exact same policy.

The law also benefits seniors on Medicare by closing the donut hole in the prescription drug benefit and by covering preventive care, including screenings, and it is saving the Medicare program billions of dollars by gradually reducing the extra amounts the government has been paying private insurers to participate in the Medicare Advantage program.

All that said, the law falls short in many ways. While it is reducing the rate of uninsured Americans, it doesn't get us anywhere close enough to the universal coverage that residents of other developed countries enjoy. While the ACA will cut the number of uninsured by half in the coming years, the CBO estimates that 31 million of us will still be uninsured in 2024.

Many of the newly insured are also finding that their choices of health care providers is severely limited in some of the health plans being offered on the exchanges. "Narrow networks" are not new -- they were common in the managed care plans of the 1990s -- but insurers gradually began to broaden their networks after widespread complaints. Now they're making a comeback.

The ACA also allows insurers to sell plans with very high deductibles. They can appear at first glance to be good deals because their premiums generally are lower than plans with more modest deductibles. But many people who enroll in high-deductible plans find out after they get sick or injured that they can't afford to pay their share of their medical bills. Although the ACA does put a limit on out-of-pocket expenses, it still will not prevent many insured families from filing for bankruptcy after a serious illness.

And while the law apparently is helping to keep medical costs in check, it doesn't go far enough. We still spend more per capita on health care than any other country. In that sense, I agree with my former colleagues in the insurance industry: The law doesn't do enough to address the "real cost drivers" of medical inflation. That will require taking on the hospital companies, physician organizations and drug makers in ways the White House and members of both parties in Congress were not willing to do in 2009 because of the political clout they have in Washington. Consequently, much more reform will have to be undertaken in years to come.

source

Wednesday, April 30, 2014

How Democrats, Republicans, and Big Medicine Sabotaged Obamacare From the Start

It was the winter of our discontent, 2009. A season of bank failures, massive layoffs and $5-a-gallon gasoline. 

Finally, a fractured country could at least agree on one thing: This had to change.

So President Barack Obama set out to deactivate the next bomb awaiting the U.S. economy, the one ticking inside our bloated, beleaguered health system. 

Since the 1990s, insurance premiums had averaged double-digit annual increases. America was spending over $7,500 per person per year — 50 percent more than Norway, the next largest contender. Health spending alone was chewing up one-sixth of the U.S. economy, double that of competitors like Japan, and putting American employers at a severe disadvantage.

john-boehner-gage-skidmore.jpg
Gage Skidmore/Creative Commons
Although Affordable Care Act enemy House Speaker
John Boehner repeatedly claims the U.S. has "the best
health-care delivery system in the world," the World
Health Organization puts us at number 36.

"We spend one and a half times more per person on healthcare than any other country, but we aren't any healthier for it," Obama told Congress in 2009. "This is one of the reasons that insurance premiums have gone up three times faster than wages."

Big Medicine had done its best to keep it that way. Since 1999, it had spent nearly $6 billion on lobbying, three times what the next-largest industry, insurance, had spent. An obedient Congress had allowed it to build a system in which millions couldn't afford coverage, huge swaths of the country were essentially served by monopolies, and prices continued to go up.

"In the decade up to 2009, 79 percent of all the growth in household income was absorbed by healthcare," says Dr. Brian Klepper, CEO of the National Business Coalition on Health. "Everything in Washington is rigged, but the thing most rigged is healthcare, because they have even more money than the banks. Both sides take money at a rapid clip from the industry in exchange for getting their own way. So everything is done in the special interest, and nothing is done in the common interest."

But that spring, with an enraged electorate and the economy in tatters, Obama was given a once-in-a-lifetime chance to break Big Med's stranglehold. He vowed to do it the old-fashioned way: by introducing competition, forcing Big Med to earn its keep.

Everyone would sit "around a big table," Obama had told a crowd in Virginia the year before. "We'll have doctors and nurses and hospital administrators, insurance companies, drug companies. They'll get a seat at the table. They just won't be able to buy every chair."

Five years later, it's hard to argue with Obamacare's success. Some 7 million people have signed up for insurance. The sick can no longer be barred from coverage, nor can the chronically ill be kicked to the curb.

Yet Republicans still rail that Obamacare is some socialist perversion. Democrats, meanwhile, often treat the plan as an illegitimate child they'd rather not acknowledge.

What both sides neglect to mention is their complicity in sabotaging the bill, selling out an unprecedented opportunity to the very guys who created the time bomb in the first place.

The president's ultimate goal was coverage for the country's 48 million uninsured. In places like Europe and Canada, the government pays basic healthcare costs for all citizens. This type of insurance is often called "single-payer," because one payer, the government, covers basic medical care.

Anyone wondering how it might function need look no further than Medicare, which runs all senior healthcare in this country. It's arguably the most popular government program in America, and one of the more cost-effective.

Start with the cost of administration. Medicare's ranges between 2 and 5 percent of its budget. For private insurance, the average is 12 percent. The Government Accountability Office once estimated that this simple savings alone would be "more than enough to offset the expense of universal coverage."

Moreover, a single provider would have the size to negotiate better prices from providers and pharmaceutical companies. According to a New England Journal of Medicine study, this would save another $400 billion and provide a boon for American business, reducing labor costs by 10 to 12 percent.

A CBS poll found that 59 percent of the public favored a government health plan. Unfortunately, the body politic is more impressed with power than with the will of the people. The insurance industry, one of the biggest players in Congress, wasn't about to get squeezed out of its lucrative role as middle man.

Insurers treat single-payer as a threat to their very existence. With a single-payer system, most health insurers would vanish overnight. So the industry set out to ensure that such a program never saw the light of day.

"Of course they don't want it," wrote Robert Reich, a former Secretary of Labor in the Clinton administration, in a 2009 opinion piece. "A public option would squeeze their profits and force them to undertake major reforms. That's the whole point."

Congress, naturally, would not allow a frontal assault on the insurance industry. So Senator Ron Wyden (D-Oregon) pitched the Healthy Americans Act, which had several Republican sponsors and significant support on both sides of the aisle.

It was a simple plan: Instead of supplying insurance to employees, companies would give that money to workers to shop for policies on their own, allowing them to pocket any savings. With so many shoppers flooding the marketplace, insurers would be forced to truly compete.

Obama's first big mistake was delegating the plan's creation to a cabal of senators and healthcare lobbyists, some still employed by the industry, some recent additions to the senators' staffs. They met behind closed doors, hashing out the details and squeezing other legislators out of the process.

Leading the effort was Senate Finance Committee chairman Max Baucus (D-Montana), who from 1999 to 2005 accepted more special-interest money than any other senator. He delegated the real lifting to his chief health aide, Liz Fowler. Baucus described Fowler as overseeing "the 87-page document which became the basis, the foundation, and the blueprint from which all healthcare measures in all bills on both sides of the aisle came."

Fowler was also a former vice president at WellPoint, the country's largest health-insurance carrier. She returned to Baucus's staff just for this occasion. As the Guardian would later write, "Few people embody the corporatist revolving door greasing Washington as purely as Elizabeth Fowler."

Meanwhile, Big Medicine donated heavily to Democrats, who suddenly began to see the industry in a far less menacing light.

Obama also started back-pedaling. "We don't want a huge disruption as we go into healthcare reform, where suddenly we're trying to completely reinvent one-sixth of the economy," he said. Avoiding a single-payer setup and Wyden's plan not only kept the donations flowing, but allowed the president to make his famous claim that people could "keep the plan that you have."

In exchange for maintaining the status quo, hospital groups pledged $150 billion in Medicare and Medicaid savings over the next decade, while insurers agreed to limit their overhead to 20 percent. Anything more would have to be rebated to customers.

"Clearly, we made a mistake in taking so much off the table before we ever started," says Congressman John Yarmuth (D-Kentucky). "We should have left single-payer on the table just so people had an idea what the extreme really was. I'm sure that was just a bone to insurance companies to get them on board."

Of all the participants in health reform, the fattest cats came out of it smelling the best — a telling indictment of Obama and Baucus.

Drugs are the most profitable sector of healthcare. Pharmaceutical companies make more than $1 trillion annually, a third of from U.S. sales. Their profits not only dwarf those of other health sectors, but pharmaceutical ranks seventh highest out of 215 industries tracked by Morningstar, an investment research company.

For years, the drug makers' consigliere was Louisiana congressman Billy Tauzin. He was a conservative Democrat who rose to the position of assistant majority whip, only to switch sides after Republicans won the House in 1994, comparing the situation to reaching a fork in the Yellow Brick Road.

"I had one hand on a party that desperately needed a brain and another on a party that desperately needed a heart, and I had to make a choice," he says today. "I decided to go with the party that needed a heart, because heart-transplant surgery was possible."

In 2003, Tauzin helped shepherd through one of the great corporate giveaways in American medicine: President George W. Bush's Medicare Part D prescription-drug plan.

The rationale for Part D was noble enough. It was designed to ease the squeeze on seniors who saw fixed incomes eaten up by the cost of their prescription drugs, which were rising at a double-digit clip.

But instead of running the government-subsidized program through Medicare, where it could have been administered at a fraction of the price, Republicans handed the job to the insurance industry. They also teamed with Democrats like Baucus and Senator John Breaux (D-Louisiana) to ban Medicare from negotiating prices.

That meant that instead of using Medicare's massive size to extract price breaks, taxpayers would have to pay whatever drug makers felt like charging the insurers. According to the Congressional Budget Office, it amounted to a $137 billion giveaway over 10 years.

When the bill took effect, drug makers saw a 34 percent spike in profits. By then, Tauzin had left Congress to become the president of the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry's trade organization. Breaux left a year later to open a lobbying firm, where he received a $300,000 contract to lobby for Big Pharma.

On the campaign trail in 2008, Obama blasted Part D's ban on negotiating, promising to get tough.

"We'll tell the pharmaceutical companies, 'Thanks, but no thanks for overpriced drugs,'" Obama had said at a Virginia campaign stop in 2008. "We'll let Medicare negotiate for lower prices. We'll stop drug companies from blocking generic drugs that are just as effective and far less expensive. We'll allow the safe re-importation of low-cost drugs from countries like Canada."

After all, there was ample evidence that U.S. consumers were being gouged. For example, in France, which negotiates prices, Eli Lilly charged patients $47 for a one-month supply of Cymbalta, a medicine used to treat depression and anxiety. The cost in America was $176.

pfizer-protest-michael-fleshman.jpg
Michael Fleshman/Creative Commons
Occupy Wall Street protestors at Pfizer's world headquarters in
New York. The pharmaceutical giant benefits from the government's
inability to negotiate a better price for their drugs -- Canadians pay
about a third less for Pfizer's Celebrex than Americans do.

Pfizer charged Canadians $53 for Celebrex, an anti-inflammatory painkiller. The bill for Americans: $162.

In one TV ad, Obama blistered Tauzin for the kind of inside corruption that's made Washington famous.

"The chairman of the committee, who pushed the law through, went to work for the pharmaceutical industry, making $2 million a year," Obama announced to the camera, his sleeves rolled up for action. "That's an example of the same old game-playing in Washington. You know, I don't want to learn how to play the game better; I want to put an end to the game-playing."

A year later, he would find that game not so unpleasant after all.

After he became president, Obama would indulge Tauzin in the same closed-door dealings he once lambasted. The drug industry agreed to taxes and rebates involving $80 billion in savings over 10 years. In exchange, Obama reneged on three crucial promises: to speed generics to market, to allow the importation of cheaper drugs, and to retain the right to negotiate Medicare drug prices.

florida-sen-bill-nelson.jpg
Senate Democrats/Creative Commons
Florida Senator Bill Nelson tried to enact legislation that would
allow Medicare to negotiate drug prices. Three Democrats --
Max Baucus, Robert Menedez, and Tom Carper -- joined with
committee Republicans to kill that idea.

Senator Bill Nelson (D-Florida) was among several congressmen who tried unsuccessfully to maintain negotiation rights. He proposed a bill that would have forced drug companies to match prices offered to other government programs (Medicaid, Veterans Administration) that do negotiate.

"I'm not here picking on PhRMA," Nelson said at the time. "I just think, philosophically, that Medicare patients shouldn't be paying more than Medicaid beneficiaries."

But three Democratic senators — Baucus, Robert Menendez (D-New Jersey), and Tom Carper (D-Delaware) — teamed with Republicans to ensure that Nelson's bill was stillborn in committee. They were more interested in keeping their word to the drug makers than in their duty to the American people.
"A deal is a deal," Carper explained.

A less-noticed provision gave pharmaceutical companies the right to extend patents on biologic drugs to 12 years, compared to the five years that conventional drugs receive. This may prove to be the greatest budget-buster of them all.

Biologics are the industry's new cash cow. They're more difficult to manufacture because they're grown rather than chemically assembled. This is the pretext for setting prices 22 times higher than those of ordinary drugs. Some prescriptions cost as much as $100,000 annually.

"Unfortunately, both the administration and leadership felt they should put a moratorium on Medicare being able to buy in bulk and access generic drugs," says Congressman Raúl Grijalva (D-Arizona). "In doing so, they locked in a price scheme that is many times out of control. That concession was painful to many of us, because we allowed the fox to control the henhouse."

Congress and the administration also repeatedly balked at the most direct route to lower prices — greater competition — even though much of the country was without it.

An American Medical Association study found that one insurer controlled more than half the market in thirty states. "In Alabama, almost 90 percent is controlled by just one company," Obama told a crowd in 2009. "And without competition, the price of insurance goes up and quality goes down."

Hit the hardest were rural residents, typically poorer and less healthy than the rest of the country. Metro areas offered the greatest profit, so big insurers and hospital groups had little incentive to compete for nickels and dimes in the countryside. Absent competition, premiums and hospital prices soared.

Many Democrats pushed for a public insurance plan, which would compete with companies like Aetna for customers. But Republicans rallied to insurers, claiming it was unfair to make them compete with government. Never mind that they represented some of the most unhealthy and least competitive stretches of the country, particularly in the South.

"We shouldn't have ever called it a public option," says Kentucky congressman Yarmuth. "We should have called it 'Medicare for all,' and then people would have been for it, because 'public option' was too vague."

mitch-mcconnell-gage-skidmore.jpg
Gage Skidmore/Creative Commons
Senate Minority Leader Mitch McConnell's home state
of Kentucky has one of the most successful state co-ops,
Kynect, which grabbed 60 percent of the market. McConnell
helped sabotage co-op funding in 26 other states.

Senator Kent Conrad (D-North Dakota) proposed a compromise by creating nonprofit insurance co-ops to compete with monopolies and provide coverage to rural areas. Actuaries suggested that $10 billion in grants would be enough to get co-ops started in every state. Yet the marionettes in Congress began to strip away their effectiveness almost immediately.

Senator Ben Nelson (D-Nebraska), a former insurance exec and one of the wealthiest members of Congress, withheld his vote unless the grants were changed to loans, making sure the co-ops were saddled with debt from the beginning.

Others sneaked in measures barring the co-ops from competing for the more lucrative business of large employers and banned them from using the government loans for marketing. It was as if Congress merely wanted fig-leaf competition while quietly sabotaging any chance to actually compete.

The $10 billion in loans was continually sheared away. Democrats repeatedly agreed to deals with Senate Minority Leader Mitch McConnell (R-Kentucky) to strip the money away.

In the end, only 23 co-ops received funding. "They don't want to do anything to make the situation in the states better," says Yarmuth. "Instead, they're actively undermining the programs."

Nobody gave the co-ops much of a chance. They had to put together plans overnight, win competitive pricing from providers, and get word of their existence out without spending any of the government loan money.

Still, many were run by real pros with decades of experience. Take Dr. Martin Hickey, CEO of the New Mexico Health Connections co-op and a former executive with Cigna and Blue Cross. "This wasn't just a do-gooder thing," he says. "This was people who understood business, understood insurance and what it was going to take to make this really work. Hope is not a strategy."

Soon, co-ops were offering the lowest premiums in a third of the states in which they operated. And even when they weren't the lowest, they were providing enough competition to drive down all premiums by 8 percent.

In New Mexico's case, Hickey found that hospital groups had a motive to expand competition.

"We were able to sit down with large groups and say, 'This market is consolidating, and the last thing you want is one or two major players, because they'll hammer the hell out of you,'" he says. "I used to work at one. I know. 'It's in your interest to give us a good rate to give us a foothold in the market. We're physician-oriented and physician-led. We get it.'"

The most thriving co-op is Maine Community Health, which has taken 80 percent of the new market from Anthem Blue Cross Blue Shield (a WellPoint subsidiary), despite comparable prices. Co-ops in Nebraska and Iowa secured more than half the market, while Kentucky's co-op grabbed 60 percent.

The latter proved a bitter irony for McConnell, who was instrumental in eliminating funding for 26 other states. Next year, the Kentucky co-op will expand into West Virginia, one of three moving into neighboring states.

"We don't need to own the whole market," says Julia Hutchins, CEO of Colorado Health Insurance Cooperative. "There's an opportunity to push the entire industry in a direction more focused on consumers, and we can do that even with a very small market share."

Of course, not every co-op has been successful. Minuteman Health in Massachusetts, Evergreen Health Co-op in Maryland, and Oregon's Health CO-OP were hamstrung by faulty websites. Others wound up on the wrong side of price, such as Arizona's Meritus Health Partners, which was dramatically undercut by private insurers.

Some, such as the Louisiana Health Cooperative, have already run into trouble. Former CEO Terry Shilling tried to turn it into a money grab for his former health consulting firm, Beam Partners, proposing a four-year contract whereby Beam would receive a $3.3 million consulting fee, a 20 percent performance fee, and up to 50 cents for every person who signed up for the plan.

Moreover, there remains the question of what happens when some of the co-ops inevitably fail. Republicans, who have attempted to subvert Obamacare at every turn, are sure to turn such failures into Benghazi-size incidents on Fox News. Those on the front lines don't possess much faith that Obama will have their backs.

"How do you spin that?" asks Hickey. "It is spin, and I'm not trying to be critical, but up until now, the administration hasn't done a great job of spin on any issue with the Affordable Care Act. So that worries me."

There's little doubt that Obamacare has achieved some remarkable things. Given that Congress can barely agree on whether to pay its bills, the simple act of helping 7 million people get insurance is extraordinary in itself.

And there is reason for optimism.

thomas-mann-brookings-institute.jpg
Courtesy of the Brookings Institute
Brookings's Thomas Mann takes a more optimistic view of the ACA: "Sometimes it takes something that looks godawful to set things in motion for some steps that will eventually give us a better system."

Brookings Institution scholar Thomas Mann is an expert in political dysfunction. He co-authored It's Even Worse Than It Looks: How the American Constitutional System Collided with the New Politics of Extremism. Considering the "Republican party's swing to the right and decision to oppose anything," he believes it's important to take a long view of Obamacare.

"He succeeded where presidents for a half-century have failed, so it wasn't going to be pretty," Mann says. "And it wasn't going to be easy."

Every expansion of the social safety net has been contentious. None kicked off without difficulties. The question is whether Democrats will be willing to wade back into the fight to address Obamacare's woes, particularly the lack of cost controls and competition, while taking endless fire from Republicans, who've shown no interest in repairing healthcare at all.

As Mann sees it, Obamacare is but the first battle.

"Sometimes it takes something that looks godawful to set things in motion for some steps that will eventually give us a better system," he says. "To the right, it looks like communism, but to more rational observers, these are constrained, incremental changes. But they could add up to something quite non-incremental."

source

Monday, November 11, 2013

Health Care Reform: The Real Issue

Everywhere someone is talking about Health Care Reform…politicians, consumer groups, and the media.  Big insurance carriers have become a target and are disparaged repeatedly for continuing to raise premiums. 

While everyone focuses on health insurance reform, no one looks at what causes these sky high increases:  the rising cost of health care.  According to the Centers for Medicare and Medicaid Services, by 2019 health care spending will near $4.4 trillion.  The California Health Care Foundation reported that health care spending is rising three times faster than inflation.  Additionally, Medicare spending is rising 10% annually while enrollment is only increasing by 2.5%.  In 2009, the most recent data, Medicaid spending increased almost 7% while enrollment only increased 2.3%.

As a result, hospitals, outpatient surgery centers, imaging centers, labs, medical groups and pharmaceutical companies seek higher payments from health insurance carriers when negotiating contracts.  Recently, some negotiations have reached impasses that only penalized patients who found themselves unable to visit their doctor or hospital due to a disruption in insurance.  Carriers are caught between politicians who scorn premium increases and providers who ask for higher reimbursements.

There are many culprits driving this high and rising cost of health care.

First is cost shifting.  As Medicaid and Medicare reimbursements decreased by 20% to 30%, hospitals and providers are attempting to shift lost revenue to insurance carriers.  To do so, they have been seeking 25% to 45% increases in coverage.  Yet with the clamor about high insurance costs, there is no way carriers can raise rates to offset these increases should they accept them, nor can they afford to absorb them.  This illustrates a major predicament facing health insurance carriers– lower health care spending and increase premiums, or lower premiums and increase the health care cost burden.

Second is lifestyle choices that result in a higher use of health care services.  It is widely known that 75% of health care costs are associated with lifestyle issues such as obesity, tobacco, and sedentary lifestyles.  These choices lead to chronic issues such as diabetes, high cholesterol, high blood pressure and heart disease that could have been prevented purely by embracing healthier lifestyles.

A third cause is medical technology.

Expensive technology accounts for about one half to two-thirds of spending growth.  Technology is now essentially mandated for compliance to HIPPA laws and is used increasingly by doctors seeking to protect themselves against medical malpractice lawsuits.  Not all this technology contributes to better care.  Technology expenses will only become worse as new tests and more costly equipment emerge.

The fourth cause comes from inefficiencies that result in the unnecessary repetition of services by multiple doctors.  An anesthesia medical group in Los Angeles told me that about 50% of the time they are forced to re-order test results on a rush basis prior to surgery because critical reports have been omitted from the charts.  In another example, I spoke with one individual who sees both his primary care doctor and his oncologist four times a year.  Both doctors draw blood and send it for lab tests.  Recently, he learned that the doctors were running the same tests.  This duplication of draws and tests also doubled costs and insurance claims.  Ultimately, carriers ended up paying double for the same services.

The fifth factor in rising costs is drug company advertising.

Doctors are prescribing more – and patients are taking more – drugs for conditions that didn’t exist a short time ago, conditions like restless leg syndrome.  The Kaiser Family Foundation reports that nearly two-thirds of Americans fill at least one prescription and the average American fills 12 prescriptions annually.  Half of all patients leave a doctor’s office with a prescription.  Yet, these same people ask more questions when buying a car than when they get a prescription for a new drug.  Additionally, patients with multiple doctors often receive a variety of prescriptions for different purposes.  Unfortunately, patients don’t always show their drug lists to each of their doctors.  This often results in new maladies from complications cause by mixing drugs, again, increasing medical care costs.

The last factor is health care fraud.  According to the National Health Care Anti-Fraud Association, it is estimated that fraud adds up to 3% of all annual health care spending, that’s $68 billion a year, or more than $180 million daily.  Better fraud prevention can only lower health care spending.

Even with health insurance reform, rising premium costs will prevail until the focus is placed on healthcare reform and these issues are addressed.  Every participant in health care – from patients to doctors to carriers and politicians – must be part of the solution in order to bend the cost curve downward.

source

Thursday, February 2, 2012

Health care reform saves Michigan Medicare recipients $49M on prescriptions

More than 84,000 Michigan residents receiving Medicare benefits saved nearly $49 million on prescriptions in 2011 under health care reform, the U.S. Department of Health & Human Services said Thursday.

Health care reform provided seniors with Medicare a 7 percent discount on covered generic medications when they hit the prescription drug coverage gap called the donut hole. This year, health care reform provides Medicare recipients a 50 percent discount on brand-name prescriptions and a 14 percent discount on generics.

"The Affordable Care Act is already saving money for millions of Americans with Medicare," Kathleen Sebelius, U.S. Health & Human Services Secretary, in a statement. "As we move forward, we will close the donut hole completely and save even more money for everyone with Medicare."

Last year, Michigan residents who hit the donut hole saved an average of $582 on prescriptions, and nationally 3.6 million Americans with Medicare saved $2.1 billion on prescriptions, according to the federal government.

source

Monday, December 19, 2011

Drugmakers get more time to record gifts to doctors

U.S. drugmakers and device companies got an extension on the deadline to record all payments and gifts to doctors because of a delay in a proposed rule from health officials.

The Physician Payment Sunshine Act, part of President Barack Obama's healthcare overhaul last year, requires manufacturers to report all payments to doctors above $10 and pay penalties if they fail to do so.

The Centers for Medicare and Medicaid Services (CMS) on Wednesday posted draft regulations that outline procedures for companies to report the information and share it with the public.

The rules were supposed to be finished by October 1 and would have required companies such as pharmaceutical giant Pfizer and devicemaker Medtronic to start collecting information on payments from January 1.

But CMS said because the rules were late, manufacturers now have until the final rule is published sometime in 2012 before they must start recording payments to doctors.

CMS said it needed extra time to draft the proposed rule in order to determine the most efficient and cost-effective way to implement the provision, and also make sure its Office of Information Systems had enough resources to make it work.

The new requirements are meant to shine light on the industry's ties to physicians, which can include pricey dinners,

golf vacations, and consulting and speaking fees.

Critics of such gifts say the perks may skew doctors' decision-making when prescribing treatments.

CMS said it would post the payment information on a public website that would be easily searchable and aggregated - a key issue for consumer groups that fought for the rule's passage.

"When people are faced with the difficult task of choosing the right doctor, they need all the information they can gather," said Dr. Peter Budetti, CMS deputy administrator for Program Integrity.

"If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it," he said in a statement.

The proposed rule would fine manufacturers $150,000 for failing to report such payments, and $1 million for knowingly failing to report them.

Companies, as well as group purchasing organizations (GPOs), would also have to report any ownership or investment stakes held by doctors. GPOs negotiate lower drug prices from manufacturers in return for guaranteed contracts from a range of hospitals and pharmacies in their system.

The rules came one day before a planned hearing in the Senate Special Committee on Aging, chaired by Wisconsin Democrat Herb Kohl, to discuss the delay in the regulations. The hearing has now been postponed.

The gifts-reporting measure was originally proposed in 2009 by Kohl and Iowa Republican Charles Grassley, and then became part of Presihttp://www.blogger.com/img/blank.gifdent Obama's healthcare law in 2010 as a way of reducing healthcare costs through greater transparency.

Both senators have sent several letters to CMS in past months, urging it to act on the rule.

"The completion of the guidance is good news," Grassley said in a statement. "It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS.

"It shows Congress has a responsibility not just to make laws but also to see that they're carried out as intended."

source

Thursday, September 1, 2011

Drug Prices Soar as Hospital Suppliers are Forced into 'Gray Market'

Michael O'Neal buys drugs for a living -- and too often these days, he's forced to do it on the "Gray Market."

Like most pharmacists charged with stocking an entire hospital, O'Neal prefers to conduct his official business for Vanderbilt University Medical Center through big-name distributors.

But there are days when his "back's against the wall," O'Neal said -- when official supply chains run dry for all kinds of drugs -- from the "bread-and-butter variety" used every day in hospitals to specialty medication for cancer treatment. On those days, O'Neal resorts to haggling on the little-known sector of the health care economy that's only a slight shade more legal than the black market.

The gray market is an expanding world fueled by a deepening drug-shortage crisis in which secondary retailers buy up medication outside of the normal, tightly controlled pharmaceutical distribution channels and then sell their stockpiled supplies to desperate pharmacists and hospitals at exorbitant mark-ups.

High blood pressure medication that normally costs $25.90, for example, can go for $1,200 -- a mark-up of 4,533 percent.

"The whole thing's squirrely, but this is always our last-ditch effort. It only happens when the manufacturer has already told us there's none in the supply chain, and we've turned to as many other sources as we possibly can," O'Neal said. "The concern that this is suspicious is overshadowed by the much larger concern of being able to get medication for a patient."

Suspicious or not, the gray market is legal.

Most drugs pass seamlessly from manufacturer to wholesaler to a pharmacy or hospital -- then on to patients. But secondary wholesalers can buy bulk drugs from the big-name distributors to supply smaller hospitals, clinics and pharmacies that don't have enough purchasing power to buy directly from the big wholesalers.

After that, medication can be traded between distributors, sometimes traveling back from these smaller distributors and pharmacies to major wholesalers through sales or returns, according to a recent report from the Pew Health Group.

Dizzy yet?

That's just the beginning -- gray-market drugs often change hands multiple times across state lines, moving in whole or partial lots that can obscure tracking information. Sometimes they're even repackaged or relabeled.

There is no national system for monitoring the path of these drugs -- that's all left to the states, which have a hodgepodge system of rules that are inconsistent and sparsely regulated.

Simply raising the price on something in short supply is only a violation of Federal Trade Commission law if companies agree to create a shortage and raise the price or if they monopolize a market by buying up a product and creating an artificial shortage. Most gray market vendors aren't large enough to do anything close.

The Food and Drug Administration's Office of Criminal Investigations looks into complaints about blatant safety concerns in the gray market but the agency defers to the states to do the bulk of regulation, said Valerie Jensen, associate director of the FDA's Drug Shortage Program.

For a pharmacist, trying to determine a product's supply source in such a web -- let alone its origins or authenticity -- can be extremely difficult.

Even if many secondary vendors in the gray market are legitimate, the whole set-up is one asking for unethical practices and outright exploitation, O'Neal said.

Most of the major manufacturers now force their distributors to sign contracts that keep them from manipulating a drug's price. But gray market vendors still manage to get their hands on these scarce drugs by other means -- and then proceed to cold-call hospitals and pharmacists at times of acute shortage with a vastly inflated sale price.

It's under these circumstances that O'Neal's office is bombarded with a steady stream of phone calls, emails, and faxes from gray market vendors looking to buy and sell.

"Overall, I tell them, 'Please don't call us, we'll call you,'" he said. "If we didn't monitor that and shut it down, it would be a constant buzz."

Those prepared to hand over a pedigree -- or a detailed record of a products' custody -- occasionally hear from O'Neal when there's no other choice.

If the drug he's trying to find typically costs $30 per case, O'Neal might send an email to his gray market contacts and receive several sales pitches -- one for $289, another for $322, and one more for $150.

"It's like just walking into a flea market and trying to argue the price down," he said. "But the crazy thing is -- these are drugs we're talking about. When you take a step back, it doesn't make any sense that this can go on."

Choose your hospital and the scene is much the same. To measure the depth of the problem, Premier healthcare alliance, a North Carolina-based quality improvement and group-purchasing organization, sent its hospital membership a request for examples of unsolicited sales offers made by gray market vendors.

The results were startling. Over a two-week period in spring 2011, 1,745 examples of gray market offers were recorded from 42 acute care hospitals. The average mark-up for shortage drugs was 650 percent. A full 96 percent were at least double the normal price, while 45 percent were 10 times more expensive and 27 percent were 20 times more.

Of the 416 separate drugs offered for sale, the highest mark-ups were for those needed to treat critically ill patients in four categories: emergency care; critical care sedation and surgery; chemotherapy; and fighting infectious disease.

Such dramatically inflated prices are forcing hospitals nationwide to collectively shell out $400 to $500 million more per year, said Blair Childs, Premier's senior vice president. And that's driving up prices across the health care industry.

But even more importantly, "it's creating safety challenges for a physician trying to ensure a patient is going to get the right drug, at the right time and that it's safe," he said. "There have been a lot of situations where there have been close calls."

Many drugs become ineffective or harmful if they haven't been stored in the right environment and at precise temperatures. While official supply chains are tightly controlled to guarantee safety, the crisscrossing nature of the gray market can throw the safety of a drug into serious doubt.

In 2009, the FDA reported several cases in which diabetic patients complained that their insulin wasn't working. It turned out the drug had been stolen and that improper handling in the gray market had caused it to lose its potency.

Gray market vendors have also been known to sell counterfeit or diluted medication, Childs said. He's even read reports of vendors buying scarce drugs from Medicaid patients in hospital parking lots.

When Bill Woodward, senior director at the Texas-based health care supply company Novation, decided to investigate some suspicious-looking pedigrees from local "distributors," he discovered that one was paying an office tower in Dallas to maintain the guise of a work space and the other was located in the false storefront of a warehouse.

"It had a 'For Lease' sign in front of it and when we looked through the window, it was just a table, a chair and a phone. They're not distributors at all," Woodward said. "The whole thing is an open door for allowing counterfeit, stolen, tainted drugs into our health care system. They could be easily inspected to see if they're actually legitimate, but no single federal agency is charged with tracking this so no one is doing that."

That's why organizations like the American Society of Health-System Pharmacists have issued strict warnings to their members, urging them to take matters into their own hands -- to demand an authentic pedigree and to ensure the vendor is authorized by the state to distribute medication, said Joseph Hill, the group's director of federal legislative affairs.

But sometimes even that's not enough to provide peace of mind, O'Neal said. He remembers one case in which the pedigree for a batch cancer medication was provided but it was still unclear whether the drug was safe, he said.

"We were in dire straights, so we still had to use it," he said. "We did as much investigation as we could. But even though you know where it came from, you don't know what the particular product has been through when it's moved through so many different hands."

Mike Cohen of the Institute for Safe Medication Practices qualifies that as "a massive concern." According to Cohen, the gray market should be more tightly regulated by the federal government.

After all, he said, this phenomenon has been around for decades -- though it's steadily increased to epic proportions in the last few years due to the toxic situation brought on by the drug shortage.

"Hospitals have patients that are sick, they need the drug, and gray is legal," he said. "So on balance, hospitals are making the decision to buy it."

A national pedigree law with legislative teeth might not solve the whole issue, he said, but it could go a long way toward making the entire market a little less gray.

source

Friday, August 26, 2011

Raising Awareness of Corporate Influence on Health Care Delivery

Nestled in the emerging Affordable Care Act is a groundbreaking provision that will require pharmaceutical companies and other medical industries to report all direct payments or gifts over $10 that are made to physicians. It's called the Sunshine Provision, and will take effect in January of 2012.

Physicians have always had a complex relationship with the health care industries. It requires careful collaboration and communication to bring the latest innovations to our patients. And who doesn't enjoy a free steak dinner in the process? But in business, collaboration often involves payment, and communication is marketing. Physicians as a group have been a slow to acknowledge that we are as susceptible to corporate marketing as everyone else on this planet, and this hubris/naïveté has allowed us to be manipulated in ways that can influence our clinical decisions.

As doctors are learning, being the recipient of a gift -- even one as seemingly benign as doughnuts for the office staff -- can confer a sense of obligation on the recipient. Over the past decade, significant data has accumulated to show that all manners of gifts shape the prescribing practices and clinical decisions of conscientious physicians in ways they may be completely unaware of. Doctors who receive gifts tend to choose the marketed product more frequently and rapidly, and acquire them for the hospital formularies at a greater rate, while their prescribing of generic drugs declines.

Free drug samples are probably the most widespread form of "gifts" to doctors. Those over-packaged samples sitting in a doctor's cabinet represent the latest and priciest versions of pharmaceutical products. The doctor may be well intentioned in passing them out -- the patient may not have insurance, or the pharmacy may be closed -- but they often cost the patient much more in the long run when the actual prescription is filled. And the fact that in the short term they were free does not mean they were the best choice of medication in that instance; they may have simply been the most convenient to reach for, or the first to come to mind thanks to that five minute chat with the very likeable drug rep earlier that day over a free bagel and cup of coffee.

Non-medically-related gifts to physicians -- tickets to an NFL game for example -- have largely become a thing of the past, as pharmaceutical companies have taken voluntary steps to restrict such overt attempts to gain favor. On the other hand, medical device industries are still famous for wining and dining specialists in exotic locations. There's nothing like an all expenses-paid vacation to a five-star resort to make an artificial hip look interesting -- especially when you are honestly convinced that palm trees and Mojitas would never cloud your objectivity about hip replacements. Clinical influence aside, there is no such thing as a free lunch. Consumers, aka patients, ultimately pick up the tab.

One of the thorniest issues around physician gifts concerns medical conferences. Doctors want to, and in most states are required to, participate in many hours of expensive continuing education. Grants from the health care industry help defray that cost. The industry has voluntarily taken measures to remove overt marketing influences from these settings, but more nuanced strategy remains. For instance, speakers (or "thought-leaders" as they are known in the industry) may offer presentations that, while factually accurate and useful, weigh much more heavily towards treatment than diagnosis and prevention. To justify industry insertion into the medical education process because educating doctors ultimately benefits the patient is like allowing soft drink vendors into schools because that will help fund after-school sports. The means shouldn't run counter to the end.

Over the past decade many of our professional organizations, like the American Academy of Pediatrics, have been working hard at raising physician awareness on these matters and providing explicit guidelines.Ethical discussions on these issues are prevalent in our professional journals. The Institute of Medicine has published recommendations on limiting the role of industry in medical education. The AMA has had a shakier role here, enraging doctors a few years ago by selling physician databases to pharmaceutical manufacturers for the express purpose of providing them marketing tools. On the other hand, landmark articles have appeared in JAMA, the AMA's journal, urging stringent restrictions on physician/industry relationships.

Meanwhile, individual doctors and practices are becoming more aware, active and vocal in the way they manage these encounters. Growing numbers of private practices limit access to sales representatives, and refuse gifts or samples from them. Some teaching hospitals now restrict the financial relationships their faculty can have with industry. The Sunshine Provision only provides a reporting system. It does not, in itself, change the way we do business in health care. But it is one more indication that doctors and society at large are coming to terms with the complex role that the health care industry plays in shaping medical practice. We will never achieve meaningful, cost-effective health care reform that puts the patient's interests first until we understand just what it is that needs reforming. For that we need transparency, and this provision of the Affordable Care Act appears to be a step in the right direction.

source

Friday, July 15, 2011

Mass psychosis in the US How Big Pharma got Americans hooked on anti-psychotic drugs.

Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses - primarily schizophrenia and bipolar disorder - to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.

It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry's development of a new class of medications known as "atypical antipsychotics." Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs - in particular, the tremors and other motor control problems.

The atypical anti-psychotics were the bright new stars in the pharmaceutical industry's roster of psychotropic drugs - costly, patented medications that made people feel and behave better without any shaking or drooling. Sales grew steadily, until by 2009 Seroquel and Abilify numbered fifth and sixth in annual drug sales, and prescriptions written for the top three atypical antipsychotics totaled more than 20 million. Suddenly, antipsychotics weren't just for psychotics any more.

Not just for psychotics anymore

By now, just about everyone knows how the drug industry works to influence the minds of American doctors, plying them with gifts, junkets, ego-tripping awards, and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs. "Psychiatrists are particularly targeted by Big Pharma because psychiatric diagnoses are very subjective," says Dr. Adriane Fugh-Berman, whose PharmedOut project tracks the industry's influence on American medicine, and who last month hosted a conference on the subject at Georgetown. A shrink can't give you a blood test or an MRI to figure out precisely what's wrong with you. So it's often a case of diagnosis by prescription. (If you feel better after you take an anti-depressant, it's assumed that you were depressed.) As the researchers in one study of the drug industry's influence put it, "the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." For this reason, they argue, it's particularly important that the guidelines for diagnosing and treating mental illness be compiled "on the basis of an objective review of the scientific evidence" - and not on whether the doctors writing them got a big grant from Merck or own stock in AstraZeneca.

Marcia Angell, former editor of the New England Journal of Medicine and a leading critic of the Big Pharma, puts it more bluntly: "Psychiatrists are in the pocket of industry." Angell has pointed out that most of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of mental health clinicians, have ties to the drug industry. Likewise, a 2009 study showed that 18 out of 20 of the shrinks who wrote the American Psychiatric Association's most recent clinical guidelines for treating depression, bipolar disorders, and schizophrenia had financial ties to drug companies.

In a recent article in The New York Review of Books, Angell deconstructs what she calls an apparent "raging epidemic of mental illness" among Americans. The use of psychoactive drugs—including both antidepressants and antipsychotics—has exploded, and if the new drugs are so effective, Angell points out, we should "expect the prevalence of mental illness to be declining, not rising." Instead, "the tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 - from one in 184 Americans to one in seventy-six. For children, the rise is even more startling - a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children." Under the tutelage of Big Pharma, we are "simply expanding the criteria for mental illness so that nearly everyone has one." Fugh-Berman agrees: In the age of aggressive drug marketing, she says, "Psychiatric diagnoses have expanded to include many perfectly normal people."

Cost benefit analysis

What's especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old - vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggests that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.

Carl Elliott reports in Mother Jones magazine: "Once bipolar disorder could be treated with atypicals, rates of diagnoses rose dramatically, especially in children. According to a recent Columbia University study, the number of children and adolescents treated for bipolar disorder rose 40-fold between 1994 and 2003." And according to another study, "one in five children who visited a psychiatrist came away with a prescription for an antipsychotic drug."

A remarkable series published in the Palm Beach Post in May true revealed that the state of Florida's juvenile justice department has literally been pouring these drugs into juvenile facilities, "routinely" doling them out "for reasons that never were approved by federal regulators." The numbers are staggering: "In 2007, for example, the Department of Juvenile Justice bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children…That's enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day." Further, the paper discovered that "One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications."

In addition to expanding the diagnoses of serious mental illness, drug companies have encouraged doctors to prescribe atypical anti-psychotics for a host of off-label uses. In one particularly notorious episode, the drugmaker Eli Lilly pushed Zyprexa on the caregivers of old people with Alzheimer's and other forms of dementia, as well as agitation, anxiety, and insomnia. In selling to nursing home doctors, sales reps reportedly used the slogan "five at five"—meaning that five milligrams of Zyprexa at 5 pm would sedate their more difficult charges. The practice persisted even after FDA had warned Lilly that the drug was not approved for such uses, and that it could lead to obesity and even diabetes in elderly patients.

In a video interview conducted in 2006, Sharham Ahari, who sold Zyprexa for two years at the beginning of the decade, described to me how the sales people would wangle the doctors into prescribing it. At the time, he recalled, his doctor clients were giving him a lot of grief over patients who were "flipping out" over the weight gain associated with the drug, along with the diabetes. "We were instructed to downplay side effects and focus on the efficacy of drug…to recommend the patient drink a glass a water before taking a pill before the meal and then after the meal in hopes the stomach would expand" and provide an easy way out of this obstacle to increased sales. When docs complained, he recalled, "I told them, ‘Our drug is state of the art. What's more important? You want them to get better or do you want them to stay the same--a thin psychotic patient or a fat stable patient.'"

For the drug companies, Shahrman says, the decision to continue pushing the drug despite side effects is matter of cost benefit analysis: Whether you will make more money by continuing to market the drug for off-label use, and perhaps defending against lawsuits, than you would otherwise. In the case of Zyprexa, in January 2009, Lilly settled a lawsuit brought by with the US Justice Department, agreeing to pay $1.4 billion, including "a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind,''the Department of Justice said in announcing the settlement." But Lilly's sale of Zyprexa in that year alone were over $1.8 billion.

Turning people into zombies

As it turns out, the atypical antipsychotics may not even be the best choice for people with genuine, undisputed psychosis.

A growing number of health professionals have come to think these drugs are not really as effective as older less expensive medicines which they have replaced, that they themselves produce side effects that cause other sorts of diseases such as diabetes and plunge the patient deeper into the gloomy world of serious mental disorder. Along with stories of success comes reports of people turned into virtual zombies.

Elliott reports in Mother Jones: "After another large analysis in The Lancet found that most atypicals actually performed worse than older drugs, two senior British psychiatrists penned a damning editorial that ran in the same issue. Dr. Peter Tyrer, the editor of the British Journal of Psychiatry, and Dr. Tim Kendall of the Royal College of Psychiatrists wrote: "The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug industry for marketing purposes and only now being exposed."

Bottom line:Stop Big Pharma and the parasitic shrink community from wantonly pushing these pills across the population.

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