Health Care Reform Articles - May 12, 2015

'On Fire While Water Skiing:' Maine Doctors Prepare for Onslaught of New Medical Codes 

By PATTY WIGHT • MAY 7, 2015

PORTLAND, Maine - The year 2015 is one some physicians have been dreading. It's the year that medical codes - the descriptions used to document your health history and submit claims - get an upgrade. The current coding system was adopted in 1979 - the same year the "Pina Colada" song came out.

The new coding system will launch in the U.S. this October, and that means health care providers have five months left to cram tens of thousands of new medical descriptions into their heads. Some physicians say the change is a boon to higher quality care. Others say it's a bust. The coding system is called the International Classification of Diseases, or ICD. While the current system - ICD-9 - came out in the 70's, ICD-10 actually came out in the 1990s. Since then, every developed country has adopted it, says Dr. Jackie Cawley, Chief Medical Information Officer at MaineHealth - every one, she says, except for the United States. "As far as we know, we are the last country. We're behind the rest of the world."

There have been previous attempts to adopt it, but every one has been delayed because it's a monumental and costly task. Every health system, every commercial insurer, plus Medicare and Medicaid, need to swap out one information system for another.

Then there's the training: ICD 9 has about 17,000 codes, says Cawley. ICD-10 has 140,000 - eight times as many. There's a code to describe nearly any medical scenario you can imagine.

Dr. Jackie Cawley: "Um, 'on fire while water skiing.' I thought that was kind of a neat one."

http://news.mpbn.net/post/fire-while-water-skiing-maine-doctors-prepare-onslaught-new-medical-codes

High prices for drugs to treat rare diseases take a toll

By Steven Syre GLOBE STAFF  MAY 12, 2015

Let me start with a confession: I had never heard of little Synageva BioPharma Corp. before another company agreed to buy it for $8.4 billion last week.

The sale of the Lexington biotech company was remarkable on many counts — none more striking than the fact that it has no products for sale.

Synageva hopes to win US approval later this year for a drug to treat a disease estimated to afflict just 3,000 people in the entire developed world. It also has some other potential drugs in its development pipeline.

The fact a company with prospects like that can be worth more than $8 billion to anyone tells you something troubling about the booming business of drugs targeting very small groups of patients.

That business relies on a particular economic premise — medicines that individually are sold at very expensive prices but collectively are palatable to the health care system because so few people take them. They may induce sticker shock, but they won’t bust the budget.

The problem: Those treatments, which can cost $300,000, even $500,000 per patient each year, won’t be a few drops in the bucket much longer. More of them are coming onto the market every year — truly good news for patients who suffered with little hope in the past, but a developing financial headache for us all.

Consider the medicines — both new therapies and existing drugs repurposed for small groups of patients — that are awarded orphan drug status by federal regulators each year. Those drugs earn extended patent protection, tax breaks, and research subsidies because they treat rare disorders.

The Food and Drug Administration granted orphan drug status to 43 medicines just in 2014. A decade earlier, only 13 therapies were recognized as orphan treatments.

Worldwide sales of orphan drugs amounted to less than $20 billion in 2000, but by 2020 are forecast to cost $176 billion, according to EvaluatePharma, a market research firm. By that year, the money spent on orphan drugs will account for about 19 percent of the world’s total drug expense.

Two important developments have encouraged many more companies and scientists to pursue expensive treatments for very rare diseases during the past decade.

One is simply a matter of technology. Drug developers now have much better tools and resources, especially for work attacking genetic diseases.

The other was the experience of Genzyme, a pioneer in the rare-disease drug business. Former Genzyme chief Henri Termeer showed how a company could thrive and prosper by targeting those diseases. The French drug giant Sanofi was so impressed that it eventually bought the Cambridge company for $20 billion in 2011.

Genzyme became a master at marketing both lifesaving drugs and high prices around the world, as described years ago by a former Globe colleague, Stephen Heuser.

http://www.bostonglobe.com/business/2015/05/11/high-prices-for-drugs-treat-rare-diseases-take-toll/qrM8s57p3EDQ2TwM5i9s5H/story.html?s_campaign=email_BG_TodaysHeadline

One girl’s hope, a nation’s dilemma

The Cambridge firm’s drug worked wonders, but was hugely costly — more than Costa Rica thought it could spend on one child among millions

By Stephen Heuser GLOBE STAFF  JUNE 14, 2009

BARRANCA DE PUNTARENAS, Costa Rica — At the time, he had no way to know it would trigger a high-stakes controversy that reached all the way to Boston, but Jose Antonio Gonzalez remembers clearly the day he first heard that there might be a drug to help his little daughter.

To Jose, it sounded like a miracle. As a toddler, Tania had been a bright girl with a vivid smile and a penchant for dancing. But by age 8 she was in a strange and frightening decline. She struggled on frail limbs to carry her swollen abdomen. As other children rode their bikes on the tiny fishing village’s dirt roads, Tania lay on the sofa in her orange cinderblock house, inert.

No one understood what was wrong. Specialists had run tests on Tania to rule out common diseases, then unusual ones. When Jose’s phone finally rang with an answer, the doctor told him Tania had a genetic defect so rare that it strikes only a tiny scattering of people around the world.

“The first thing he said was, she could die,” said Jose, a somber and powerfully built man. “The strength I was supposed to carry with me just vanished.”

But the doctor had another piece of news. There was a drug that might halt Tania’s suffering and perhaps even reverse the toll of her disease. The drug was called Cerezyme.

For Jose and his family, it was as though a hand had reached down to answer their prayers. But in that moment, something else had happened as well: The Cambridge drug company Genzyme had just found its first potential patient in Costa Rica. And now that it had found one, it would supply the drug to Tania, but at an astonishing cost - $160,000 a year, possibly for the rest of her life.

This was far more money than the Costa Rican government had ever paid for a drug, and Genzyme would not bend on the price. The country’s health officials were forced to weigh the prospect of a healing gift for one girl against the needs of a nation struggling to care for millions.

Should Tania get the drug?

What unfolded in that village was a dramatic example of the hard choices often forced by the inventions and ambitions of the biotechnology industry, an increasingly important part of global healthcare and a critical growth sector for Massachusetts. Its high-priced cures are creating both great wealth and great moral dilemmas, one new drug, one new patient at a time.

Jose Gonzalez felt indescribably lucky that his little girl, wasting away beneath hibiscus vines in Central America, had been found. But for Genzyme, it wasn’t luck. It was another step in a remarkable business strategy: In countries from Colombia to Taiwan to Libya, the Cambridge firm has compiled an extraordinary track record of searching out patients like Tania, providing desperately needed treatment, and then successfully pressing their governments, even poor ones, to pay full price for the most expensive drugs in the world.

That strategy has helped Genzyme bring in more than $1 billion a year on Cerezyme alone, and to develop an arsenal of similarly expensive drugs for other rare diseases. And Costa Rica would soon learn a lot about Genzyme’s determination to be paid when it considered the cost of saving Tania Gonzalez, how it would drain resources from other patients, and decided that its answer was “no.”

The discouraging march of Tania’s illness had been part of the Gonzalezes’ lives since the night in 1996 that her bowels had emptied suddenly in her crib. Her parents suspected that this was not a typical childhood accident, and after they drove Tania 15 minutes to the doctor, they quickly learned they were right. The baffled doctors noted Tania’s arms and legs were oddly thin, and her spleen enlarged - “very strange things in a 3-, 4-year-old girl,” said Jose.

http://www.bostonglobe.com/business/2009/06/14/one-girl-hope-nation-dilemma/OF8QtSWq9VRHxcjLn2yK1N/story.html

Americans could soon be thanking Fidel Castro for their revolutionary cancer drugs

By Michael E. Miller May 12 at 6:27 AM

Cuban health care is a keen topic of debate here in the United States.

If your allegiances lie on the left of the political spectrum, you’re likely to see the communist government’s clinics as godsends — well, Che Guevara-sends — responsible for a life expectancy on the poor island on par with that of its rich northern neighbor.

If you’re conservative, you’re likely to recite horror stories of medical shortages or doctor defections under the Castros. For every Michael Moore talking up Cuban health care, there is a Marco Rubio ready to tear it right down.

Whatever your stance on Cuba’s system, however, you could soon benefit from its medical advances, particularly when it comes to cancer. In fact, Americans suffering from the emperor of all maladies might soon be thanking Fidel for his country’s miraculous medications.

Recent improvements in relations between the two archrivals are leading to agreements that will soon bring Cuban cancer drugs to the United States. When New York Gov. Andrew Cuomo (D) visited Havana last month, it was partly to shore up an accord between New York’s Roswell Park Cancer Institute and Cuba’s Center for Molecular Immunology that will bring the Cuban lung cancer vaccine Cimavax to the United States for clinical trials, Reuters reported.

While not a cure for cancer by any means, Cimavax is a powerful and incredibly cheap cancer drug in Cuba. “Medical researchers at the Center for Molecular Immunology worked on Cimavax for 25 years before the Ministry of Health made it available to the public — for free — in 2011,” Wired reported. “Each shot costs the government about $1. A Phase II trial from 2008 showed lung cancer patients who received the vaccine lived an average of four to six months longer than those who didn’t.”

Cimavax is no fluke. Instead, it’s a product of a Cuban government that — whatever you think of its politics or human-rights record — has been praised for its pioneering medical and biotech research. “After the 1981 dengue fever outbreak struck nearly 350,000 Cubans, the government established the Biological Front, an effort to focus research efforts by various agencies toward specific goals,” Wired wrote. “Its first major accomplishment was the successful (and unexpected) production of interferon, a protein that plays a role in human immune response. Since then, Cuban immunologists made several other vaccination breakthroughs, including their own vaccines for meningitis B and hepatitis B, and monoclonal antibodies for kidney transplants.” All this is even more impressive considering the crippling embargo that America has imposed on the island for half a century.

http://www.washingtonpost.com/news/morning-mix/wp/2015/05/12/americans-could-soon-be-thanking-fidel-castro-for-their-revolutionary-cancer-drugs/?tid=hp_mm&hpid=z3

Maine lawmakers hear impassioned arguments on vaccination opt-outs

Rival sides pack hearings to take a stance on bills to limit or stop parents from declining shots because of philosophic objections.

BY JOE LAWLOR STAFF WRITER

AUGUSTA — A standing-room-only crowd gave impassioned testimony to the Legislature’s Health and Human Services Committee on Monday, arguing for and against restrictions that would make it harder to opt out of childhood vaccinations.

Maine has one of the highest voluntary opt-out rates in the nation, and public health experts have warned that the levels of unvaccinated children could result in the return of vaccine-preventable diseases such as measles, pertussis, polio and mumps. The issue has attracted national attention since this winter’s measles outbreak at Disneyland in California.

Two bills before the committee would target the philosophic exemption, which is used by more than 90 percent of parents who choose to not vaccinate their children. Vaccines are a requirement for entering school, but Maine has one of the more lenient laws in the country for opting out, based on how easy it is for parents to forgo immunizations, public health experts say. In Maine, parents can simply sign a form opting out on religious or philosophic grounds.

One bill, sponsored by Rep. Linda Sanborn, D-Gorham, a retired family physician, would require a consultation and a signed note from a medical professional before parents could use the philosophic exemption to forgo vaccines for their children entering kindergarten. A second bill, from Rep. Ralph Tucker, D-Brunswick, would eliminate the philosophic exemption. The religious exemption would remain unchanged under both bills.

http://www.pressherald.com/2015/05/11/maine-hearings-on-vaccinations-draw-impassioned-arguments/

Public campaign needed for national health service in Ireland

By Caoilfhionn Ní Dhonnabháin
Slugger O'Toole blog, May 10, 2015
In the South we often look enviously at the British National Health Service.
From the injustice and inequality of our two tier system, from our GP waiting rooms where we will have paid €50 or €60 to see a doctor, we see how the NHS was at the center of the debate in the British General election campaign.
As efforts to push citizens in the South into the private health market are ratcheted up we see the growth of grassroots campaigns in support of the NHS. We have heard the emotive words of campaigners such as Harry Leslie Smith who called on the British people to stand up and defend the NHS.
Yes, we recognise that the NHS has its own problems. Under the Tories it has suffered from cut backs and attempts to pursue a privatisation agenda. And with the election of a majority Conservative government the future for the NHS is far from secure.
But for now the debate is quantitatively different.
NHS campaigners are fighting to keep what they already have – to retain something which many British people feel great pride in.
Here those of us who want to see a universal health system are fighting for something we have never had.
And the odds are stacked against us.
Against us stand the vested interests. The private health profiteers. The proponents of neoliberalism. The EU rules on spending and borrowing brought in by way of the Fiscal (Austerity) Treaty.
But there is too much at stake to let that stop us.
We all know people who have been let down and failed by the two tier health system.
We know people who cannot afford health insurance but have borrowed money to have a cancer test privately because the time they are expected to wait in the public system could put their lives at risk.
And we know people who can neither afford insurance nor to borrow for healthcare but who have to wait. Sometimes in pain. Sometimes in fear.
We have seen public patients with late diagnosis die where private patients survive.
An example of this was the high profile case of health campaigner Susie Long.
Her story of her seven month wait for a colonoscopy in the public health system in 2005.
Her late diagnosis.
Her encounter while undergoing chemotherapy with a private patient who had been referred for a colonoscopy at the same time as her but got it after 3 days.
His survival.
Her death.
There have been many other cases just like this.
So many ordinary people whose stories will never be told.
This is an inequality and injustice which many of us are simply not prepared to accept.
So how is it then that we do not have a more vocal public campaign for a national health service in Ireland?
It is back to how this debate is framed and how the dominant political ideology over recent years has seen a greater focus on putting money back in people’s pockets than on strengthening public services.
But for most people on low and middle incomes the pennies they put back in your pocket won’t buy you the healthcare you need.   Remember Susie Long’s case occurred in the boom years of the Celtic Tiger.
http://www.pnhp.org/news/2015/may/public-campaign-needed-for-national-health-service-in-ireland