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Tuesday, June 26, 2018

Health Care Reform Articles - June 26, 2018

Why Universal Health Care from Birth Is a Bedrock Right for Any Civilized Society

by Nancy Altman - Alternet - Independent Media Institute - June 20. 2018

It is well past time that we make Medicare for All a reality. It should have been enacted decades ago.
On July 2, 1932, Franklin Roosevelt, in his speech accepting the Democratic Party’s presidential nomination, “pledge[d]… a new deal for the American people.” He proclaimed, “Let us now and here highly resolve to resume the country’s interrupted march along the path of real progress, of real justice, of real equality for all of our citizens, great and small.”
He believed that the government should be a force for good for everyone. He explained:
“There are two ways of viewing the Government’s duty in matters affecting economic and social life. The first sees to it that a favored few are helped and hopes that some of their prosperity will leak through, sift through, to labor, to the farmer, to the small business man…. But it is not and never will be the theory of the Democratic Party.”
Roosevelt knew what government of, by, and for the people should do. He had a clear and far-sighted vision. He recognized that with the rapid industrialization and urbanization of the last half-century came new insecurities. He understood that good-paying jobs, as well as first-class education and insurance against the loss of wages, were essential. He knew that for American workers to have true economic security, they would require a healthy mind and body. Therefore, he saw that we must have universal guaranteed health care starting at birth.
FDR considered proposing universal health care in 1935, at the same time as Social Security. But the forces arrayed against it were too strong. Nevertheless, Roosevelt and his colleagues thought that universal, guaranteed, government-sponsored health insurance was right around the corner.
In 1938, Molly Dewson, who was one of the members of the three-person Social Security Board (the predecessor to the Social Security Commissioner), gave a speech about Social Security at the Women’s City Club of Boston. In it, she predicted, “Adequate health protection may still be mostly pious hope. But it is not a vain hope; [it is] already on the horizon.”
But World War II intervened. Even then, universal government-sponsored health care was not far from the thoughts of Roosevelt and his colleagues. In Roosevelt’s 1945 State of the Union message, he talked about his post-War plans:
“An expanded social security program, and adequate health and education programs, must play essential roles in a program designed to support individual productivity and mass purchasing power. I shall communicate further with the Congress on these subjects at a later date.”
But that later date never came. He died a few months after that message. His successor, President Harry Truman, pushed tirelessly for universal health care, but to no avail. The special interests arrayed against him were still too strong.
So, led by President Lyndon Johnson, those who understood the importance of universal, government-sponsored health insurance decided to take a novel, incremental approach: Medicare. Just a few years after its enactment, Medicare was extended to people with disabilities. It looked like just a matter of time until children would be added, and then everyone else.
If Medicare for All had been enacted decades ago, as it should have been, it would have alleviated enormous suffering and saved lives, not to mention trillions of dollars of our nation’s wealth. We should make it a reality now.
For those who recognize that government should be a force for good in our lives, who support Social Security, a minimum wage, eight-hour workdays, and all the other benefits government has brought us, Medicare for All is a critical step forward in that march of progress. Better late than never.

Soaring costs, loss of benefits top Americans' healthcare worries: Reuters/Ipsos poll

Maria Caspian - US Legal News - June 15, 2018

(Reuters) - For over a year now, Americans have listed healthcare as the most important problem facing the country, according to Reuters/Ipsos polling. 

An examination room is seen at an onsite health clinic at the Intel corporate campus in Hillsboro, Oregon, U.S., April 25, 2018. REUTERS/Caroline Humer 
When asked what concerns them about U.S. healthcare, this is what they had to say: 

TOTAL COST OF HEALTH INSURANCE 

Sixty-five percent of Americans said in the poll that they are “very concerned” about the overall cost of health insurance, including premiums, deductibles and copays. 
This concern is consistent throughout the country: A majority of both millennials and baby boomers, whites and minorities, Democrats and Republicans were worried about healthcare costs. 

PRESCRIPTION DRUGS 

Nearly three in four Americans use prescription drugs, and 58 percent said they are “very concerned” about the cost of paying for them, according to the Reuters/Ipsos poll. These drugs are expected to see the fastest annual growth over the next decade, rising an average of 6.3 percent per year, according to the U.S. Centers for Medicare and Medicaid Services (CMS). 
Reuters PollingMore data-driven stories from Reuters

CHOOSING CARE 

Sixty-six percent of U.S. adults who took part in the survey said they were concerned about their ability to see a doctor of their choice going forward. 

An emergency room nurse wears a mask as he deals with flu patients at Palomar Medical Center in Escondido, California, U.S., January 18, 2018. REUTERS/Mike Blake 

MEDICARE AND MEDICAID 

About one in three U.S. adults said they were “very concerned” about losing benefits from government-run programs Medicare and Medicaid. 
Enrollment in Medicare is expected to increase as baby-boomers reach retirement age, according to CMS projections, which will contribute to growing healthcare spending.  
The poll also showed that 58 percent of Americans think Congress should keep the Affordable Care Act either entirely as it is, or with some fixes, while 24 percent think lawmakers should repeal it once an alternative law is passed and 18 percent want the ACA to be repealed immediately. 
The Reuters/Ipsos poll surveyed 3,982 people in English in the United States from May 22 to June 3 and it has a credibility interval of about 2 percentage points. 
For more Reuters polling, visit polling.reuters.com/

Bezos, Buffett, Dimon health venture will be based in Boston

by Felice Freyer - Boston Globe  - June 20, 2018

Three of the country’s best-known business leaders have turned to Dr. Atul Gawande, a Boston surgeon and best-selling author, to head their new company aimed at reinventing how health care is delivered.
In announcing Gawande’s appointment Wednesday, investor Warren Buffett, Amazon’s Jeff Bezos, and JPMorgan Chase CEO Jamie Dimon said their still emerging and still unnamed health care venture will be based in Boston. It remains unclear what exactly the company will do, but Gawande’s appointment suggests it is aiming high.
“What it says is that they’re thinking very big,” rather than narrowly focusing on technical issues like purchasing, said Dr. Robert M. Wachter, chairman of the Department of Medicine at the University of California San Francisco.
The new company, which the founders said would be “free from profit-making incentives and constraints,” was established to improve health care and reduce costs for the 1.2 million employees of the three founders. But given the founders’ clout, the venture’s successes could become a model for health care around the country.
“What’s interesting about these big companies is they can use their employees as a laboratory,” said Kenneth Kaufman, managing director of Kaufman Hall, a health care consulting firm. “To create a laboratory model that changes health care in the US? That’s something that gets Atul up in the morning.”
Gawande, a surgeon at Brigham and Women’s Hospital, declined a request for an interview through a spokeswoman. In an e-mail to colleagues, he said he would continue working as a surgeon at Brigham and Women’s Hospital and a Harvard Medical School professor. He also will also remain a staff writer for The New Yorker magazine, where his articles have shed light on the challenges facing the health care system.
But he will leave his position as executive director of Ariadne Labs, the research center he founded, and become its chairman instead.
Gawande, 52, said he would start work July 9 at the new organization, which he called “one of the most promising opportunities to accelerate improvement of US health care delivery.”
“My vision,” he wrote, “is to develop high-impact collaborations across the health care sector.”
Gawande said he would build upon the work at Ariadne Labs, which develops systems to improve the delivery of care. These include checklists to prevent surgical errors, a guide to help clinicians talk with patients about their goals and values when seriously ill, a project to reduce C-section rates by improving communication with patients, and other initiatives focused on interactions between patient and physician.
The announcement of Ga-wande’s appointment comes at a time of upheaval in the health care industry, as companies reach beyond their traditional service areas. CVS, for example, has attempted to reinvent itself through the acquisition of insurance provider Aetna and is repositioning its brick and mortar stores as health care centers. 
Meanwhile, Amazon is also moving into health care on another front. The company has an internal “Grand Challenge” team called 1492 that focuses on disrupting the industry. The online giant has recently made several high-profile hires of clinicians, pharmacy experts, and former employees of the US Food and Drug Administration. 
And last month, a group of Massachusetts businesses launched an initiative intended to cut costs by reducing the number of people who use hospital emergency rooms for routine care.
The new Boston-based company is taking aim at a notoriously inefficient health care system, which Buffett has likened to a “tapeworm.” US health care spending increased 4.3 percent in 2016 to reach $3.3 trillion, or $10,348 per person, according to the Centers for Medicare & Medicaid Services. 
Dr. Donald M. Berwick, former administrator of the Centers for Medicare & Medicaid Services under President Obama, said aides to Buffett, Bezos, and Dimon have spent the last six months talking to experts in health care about their company and who should lead it. 
Berwick, president emeritus of the Boston-based Institute for Healthcare Improvement, rejected the idea that it’s going to be just a well-funded think tank. 
“I think it’s going to be a do-tank,” he said. “It’s an activist move by organizations that really do want to make a change, and they have picked a leader in Atul Gawande who is almost uniquely capable of crafting the changes that are going to be needed.”
Gawande’s appointment was cheered by many others in the medical and public health communities.
“US health care obviously needs a heart transplant,” said Dr. Elliott Fisher, director of the Dartmouth Institute for Health Care Policy and Clinical Practice. “Who better than a surgeon, with deeper knowledge of US health care than anyone I know, to guide this effort?”
Andy Slavitt, another former administrator of the Centers for Medicare & Medicaid Services, said Gawande “has a brand and reputation as somebody who is not going to do anything that isn’t in the best interest of public health.” 
But some questioned whether Gawande knows enough about business and criticized his decision to continue performing surgery and writing while undertaking the new position.
For an enterprise that aims to transform health care, said Craig Garthwaite, professor at Northwestern University’s Kellogg School of Management, “I would think you want someone with more business expertise.” 
“Atul Gawande is thinking a lot about making the delivery of health care more efficient. It would surprise me if that’s what you’re trying to do with the Amazon venture,” Garthwaite said, adding that it’s hard to change health care delivery from outside the institutions that provide it.
He also questioned Gawande’s decision to continue performing surgery and writing. “Being a CEO is a full-time job,” he said.
Andrew Dreyfus, CEO of Blue Cross Blue Shield of Massachusetts, dismissed those criticisms. Calling Gawande “a spectacular choice,” he noted that the surgeon manages Ariadne Labs and has a deep understanding of systems and management. “The fact that he’s going to still be a surgeon will increase his credibility as he designs changes in the health care system,” he said. 
Because Gawande is widely respected, when he proposes changes, “Everyone is going to pay attention,” Dreyfus said.
Gawande, a prolific writer, is known for his books, “Complications,” “Better,” “The Checklist Manifesto,” and “Being Mortal.” He has been a staff writer for The New Yorker since 1998, according to his website. He has won awards for his writing and, in 2006, was awarded a MacArthur “genius” fellowship.

Now We See: How The Opioid Crisis Has Laid Bare Deep Flaws In American Medicine

by Dr. Elizabeth Poorman - CommonHealth - June 15, 2018

I now know that everything that I was taught about opioids was wrong.
My thinking began to change after meeting a patient I’ll call Danny. A man in his 50s, overweight and over 6 feet tall, he was an imposing physical presence. I could tell he had once been handsome before years of living on the streets; even in his hospital bed, his dark brown hair was impeccably groomed.
Danny had recently left a physical rehab center where he had been given the largest doses of opioids I had ever seen for his chronic back pain. Eventually, he was sent out onto the streets with a week’s prescription and no followup plan. He ran out of pills in a few days.

He walked into our emergency room demanding that we give him opioids. When the ER doctors hesitated, he screamed and threatened them.
This was 2013, two years after the Centers for Disease Control and Prevention had declared that America was in the midst of a prescription drug epidemic. Yet most physicians continued to write prescriptions for opioid medications at record levels.
We had been taught that patients were either in pain or they were drug-seeking addicts -- never both. Patients with chronic pain who started to show addictive behaviors, we were told, were not addicted but “pseudo-addicted,” suffering because we were not giving them enough opioids.
"Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated,” according to a statement in 2001 from the American Pain Society and the American Society of Addiction Medicine. Even illicit drug use was to be seen as a sign that we were not giving enough opioids.
In other words, don’t question your patient’s behavior: Prescribe more pain pills.
The concept of pseudoaddiction, I recently learned, was coined by David Haddox, now a longtime employee of opioid-maker Purdue Pharma and former chairman of the American Pain Society.
Beyond that single 2001 statement, there has never been empirical evidence that pseudoaddiction is a legitimate diagnosis. Yet, in spite of its questionable assumptions, the term was doctrine in pain treatment while I was in medical training, spread throughout the medical community by pharma-sponsored lecturesand educational materials.
It was this line of thinking that guided me when I was taking care of Danny. I did not want to give him the opioids. But I worried that I was acting out of bias -- that I didn’t want to give Danny opiates because he was living on the streets, he was unpleasant, and he intimidated me. With all this in my head, and my desire to win Danny’s trust, I decided to give him the medications. My training taught me that it was the right thing to do.
All of us who continued to prescribe these pills closed our eyes to his intensifying addiction.
For the next few days, I walked into Danny’s room every morning to check on his progress. After each dose of opioids, I saw his head drop, his pupils shrink, his breath slow -- early signs of an opioid overdose.
I had followed all the guidelines, but I knew then that I hadn’t given Danny the care he needed. All of us who continued to prescribe these pills closed our eyes to his intensifying addiction. After about a week, I sent Danny back out onto the streets.
Why Didn't We See?
It’s hard to understand now why I couldn’t recognize that Danny was suffering from chronic pain and addiction, or that the two commonly coexisted. It is even more painful to acknowledge that during most of my medical training, the teaching I received was so thoroughly dominated by corporate interests pushing pain prescriptions that we let it blind us to flimsy data and even our own clinical experience.
When some physicians were reluctant to prescribe opioids, hospitals pointed out their importance in increasing patient satisfaction scores. When it was noted that racial minorities received fewer pain pills, hospitals encouraged physicians to prescribe more opioids to everyone in the name of reducing disparities. We accepted teaching from pharmaceutical companies that opioids caused addiction in less than 1 percent of patients with “legitimate” pain, and that they were effective for chronic pain.
While opioids certainly have a role in acute pain, there was never any hard evidence that they were effective or safe for chronic pain conditions. When OxyContin, Purdue’s blockbuster opioid, received FDA approval, the company had conducted no studies on how often longer-term consumers developed an addiction. And studies that were used to justify prescription opioids for chronic pain lasted just six to 12 weeks.
We now know that having a diagnosis isn’t a magical safeguard against the dangers of these drugs. A quarter of those who are prescribed opioids for chronic pain will misuse them, and about one in 10 will develop an opioid addiction. And the first-ever study of opioids for chronic pain to last at least 12 months, published this year in JAMA, found that opioids were less effective than other medications for arthritis and chronic back pain, and had twice as many adverse effects.
Some doctors also believed that they could accept all-expense-paid trips to places like Boca Raton and Scottsdale funded by pharmaceutical companies, free lunches and free samples from pharma reps, follow guidelines written by doctors with multiple conflicts of interest, and still make the right decisions for patients. We ignored — and continue to ignore — research that suggests as little as $20 in food changes doctors’ prescribing practices.
Looking back, it is clear that opioid manufacturers offered an easy answer to the difficult problem of chronic pain, allowing doctors to feel like we had done something to help our patients. As Dr. Anna Lembke, program director for the Stanford University Addiction Medicine Fellowship, said in a talk last year, “There’s tremendous pressure on doctors to palliate pain, to prescribe pills and perform procedures because that’s what pays, and to please patients because patients have become customers. Guess what? Opioids are a pretty good solution to that problem.”
Patients mistakenly think that I can write a prescription to safely wipe all their pain away -- and it’s uncomfortable for me and other doctors to admit that we can’t.
Colleague And Patient Challenges 
Now, even when I try to do the right thing by limiting opioids, my efforts are often undermined by other doctors with freer prescription pads.
Recently, I was unable to convince one of my patients of the dangers of opioids. We talked about it over several visits. I knew that she had an anxiety disorder, a huge risk factor for abuse. I knew that she had little social support. I knew that the opioids might provide her short-term relief, but were unlikely to help with her chronic nerve pain, which she would probably live with for the rest of her life.
But even though I talked to her about the risks, she still kept asking for pain pills. One day, I gave in. I gave her a few weeks of pills until her scheduled surgery for chronic pain. After her surgery, I got a note from her surgeon: She had been discharged from the hospital with 30 days of high-dose, round-the-clock opioids with no followup plan. I haven’t seen her since.
Dr. Andrew Chambers, director of addiction psychiatry training at Indiana University School of Medicine in Indianapolis, shares my frustration.
“The biggest cause of relapse in my [opioid-addicted] patients is getting health care from a dentist, a surgeon, a primary care doctor or an ER doctor," he told me. "How do I treat addiction that’s being caused by two other doctors? If I want to, then I need to track them down and convince them what they’re doing is wrong, and I don’t get reimbursed for that."
Moving forward with patients means starting with honesty about our limitations as providers. Lembke says she breaks the truth to patients this way: “There’s a possibility that there’s nothing that modern medicine has that will help your pain, and I’m very sorry about that. But at the very least we can try to not make things worse.” Lembke explains to them that opioids may help in the short-term, but the only safe solution is “to harness your creativity to find how to make your life worth living, even while we may not be able to stop your pain.”
Pills alone aren’t the solution, Lembke tells her patients, and I’ve started telling mine. Medications all have potential side effects whose consequences multiply the longer they’re used. Safer, more effective therapies long term include things like physical therapy, psychotherapy and mindfulness, which, unlike opioids, have all been shown to improve quality of life.
When our goal is primarily palliative care, opioids are an important treatment option, including for frail elderly patients who cannot safely take alternative medications. And for many patients who are on high doses of opioids and have not shown any signs of addiction, it may be safer to continue them, or discontinue at a very slow pace and only with the patient’s buy-in.
For many, however, this option is no longer available, as some physicians refuse to prescribe opioids under any circumstances, or to take on patients on chronic opiate therapy. These patients are left without support as they abruptly discontinue medications they have been taking for years, and may be physically dependent on.
We have failed to come to grips with the scale of destruction we have created ... and the work we have to do to combat this epidemic and prevent future ones.
When patients show signs of an addiction, many physicians opt to simply sever ties with the patient. Few offer treatment. Buprenorphine, a drug used to treat opioid addiction like methadone that also helps prevent overdose, is an important option I’ve seen work in practice. Buprenorphine and methadone reduce mortality for patients with opioid addiction by half. But only 3 percent of doctors are certified buprenorphine providers, and fewer than a quarter of residency programs offer training. How can we interpret these statistics except as a lack of seriousness about addressing a crisis we helped create?
Things have changed since I was an intern. Some physician groups, including the American Medical Association, are eager to tout successes such as decreasing numbers of prescription opioids. These efforts are important, but they are belated to say the least, and woefully anemic. We have failed to come to grips with the scale of destruction we have created, the ways our clinical decision-making was and still is vulnerable to corporate greed, and the work we have to do to combat this epidemic and prevent future ones.
Patients have a right to be angry with us for the way we’ve (mis)treated them with opioids. We need to give each patient the time they need, make changes slowly, and understand that some will not be able to get off of these medications. We need to ask for help from colleagues and demand that our institutions support safe opioid prescribing and addiction treatment.
Every generation of physicians has to work to undo the mistakes of its predecessors. It is the nature of working in a constantly evolving field. But the physician-fueled opioid epidemic is something different: the result of an effective marketing campaign that has killed hundreds of thousands of people.
As a medical community, we continue to play fast and loose with the corrupting influence of money on our clinical decision making. We allow it into our guidelines, our most prestigious societies, our medical education, our patient advocacy groups, our offices and operating rooms.
Important progress has been made. We are exposing fewer patients to these dangerous and largely ineffective drugs. But the fundamental weaknesses in American medicine that led to this crisis remain unchanged: short time with patients; a customer-service mindset that prioritizes satisfaction over good medicine; the largely unchecked influence of money on our providers and health care leaders; and an unwillingness of physicians to diagnose and treat addiction.
The opioid epidemic has laid bare the flaws of American medicine. We should be willing to look at them. Otherwise, this will not be the last epidemic we create.
Elisabeth Poorman is a primary care doctor in Everett, Massachusetts, and a clinical instructor at Harvard Medical School. She is on Twitter at @DrPoorman.


Advice for Gawande as he takes up tall health care challenge
by Liz Kowalczyk - Boston Globe - June 21, 2018

They’ve made a big splash, but three powerful business leaders who want to reinvent health care have been short on details about their venture. They took a notable step forward on Wednesday, recruiting Boston surgeon and prolific author Dr. Atul Gawande to head their new, still-mysterious company.
Berkshire Hathaway chief Warren Buffett, Amazon’s Jeff Bezos, and JPMorgan Chase chairman Jamie Dimon aim to improve medical care and lower its cost for their employees, and become a national model. But exactly how they envision doing that is unclear — especially in a field with no shortage of ambitious plans and ideas. 
“The lack of details makes it a little bit of a shot in the dark,’’ said Dr. Lisa Bielamowicz, a health care consultant in Washington, D.C. It “doesn’t point to a lot of meat there yet.’’
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So far, little else is known about the venture, other than that it will be based in Boston, and that it has the medical world abuzz because of the big names and big aspirations.
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The Globe asked Bielamowicz and several other experts where Gawande should start in taking on overhauling health care.
* It’s all about Amazon and customer service. Bielamowicz said that employer health care coalitions have made only incremental progress in the past — using group purchasing to negotiate lower prices on prescription drugs, for example — but have failed to produce transformative ideas. 
“But one of the things Amazon has done very well is they view consumer value as the guiding light for every decision they make,’’ she said. 
A case in point: Free shipping. It seemed counterintuitive at first but has “been core to developing a deep relationship with customers. How do you create an Amazon Prime for health care? How do you deliver so much value that people want to be a member?’’ she asked.
Andrew Dreyfus, chief executive of Blue Cross and Blue Shield of Massachusetts, agreed that Amazon should bring its deep analysis of customer needs to the health care industry.
Health care is “generally designed around the needs of institutions and health professionals and not around the needs of individuals,’’ Dreyfus said. “Whether we call them patients or consumers, they find health care confusing, fragmented, and sometimes even hostile to their needs. In the retail environment, we expect on a 24/7 basis to be able to search, purchase, and have an easy transaction. Those adjectives do not describe the health care experience.’’
Patients who have a better experience, Dreyfus said, may be more motivated to follow their doctor’s advice and take their medications. 
* Amass data and then tackle easier problems with big returns. Dr. Ashish Jha, a professor of global health at the Harvard School of Public Health, said the founders of the new venture, which does not have so much as a name yet, probably are counting on “the new leadership to articulate and develop that vision and execute on it. That’s why the companies themselves have said ‘we are not going to discuss details.’ ’’
Since an initial aim appears to be improving medical care for the 1.2 million employees of the three companies, Jha said a first step should be to analyze data about the cost of their care and their health status. “That is going to be the thing you want to track in how you move the needle,’’ he said.
Then, he suggests starting with “low-hanging fruit” like addressing so-called price variation in medical spending. This phenomenon is well-documented in Massachusetts, where insurers and consumers pay hundreds of dollars more for imaging tests at top Boston teaching hospitals than they pay at outpatient centers — with no appreciable difference in quality.
Convincing employees to go to lower-cost sites would bring relatively large savings quickly, Jha said. Insurers try to steer patients in this way, but people don’t like to be told where to go, and sometimes patients go where doctors refer them, especially if they are not paying.
But Jha said patients may not mind restrictions on where they can get imaging tests as much as they do on which doctor they can see. And, he said, the companies could provide bigger incentives to patients who get care from lower-cost providers, such as a $100 gift card for Whole Foods Market, which Amazon bought last year.
Gawande “should go for sizable but easy victories up front,’’ Jha said.
* Attack high-cost areas such as care of the chronically ill and prescription drugs. About 5 percent of patients, many who have long-term chronic illnesses, account for half of all health care spending. Dreyfus said that group is ripe for innovation. 
“This has long been a target of health care organizations and some have recently been making some progress, but no one has really broken through in a big way,’’ he said.
Often, providers will improve care and save money for a narrow population, such as elderly patients in one community with congestive heart failure, but the success won’t be replicated. That ability to apply solutions on a large scale plays directly to Gawande’s strengths; he worked with the World Health Organization to bring pre-surgical checklists to hospitals around the world to reduce operating room errors and infections.
Prescription drugs are another logical focus, said John McDonough, a former state representative and consumer advocate and now a professor of the practice of public health at the Harvard School of Public Health. But he said it would be presumptuous to suggest how the new venture should approach its goals when the very point is to think outside the box.
“They are making it up as they go along,’’ McDonough said. “It’s new, it’s ambitious, and it’s supposed to be out of the box. They are being thoughtful and careful about what they want this to be and how it will unfold. Putting someone in charge is a big step forward and they are almost looking to [Gawande] to figure it out.’’



House GOP plan would cut Medicare, Medicaid to balance budget
by Erica Werner - The Washington Post - June 19, 2018

House Republicans released a proposal Tuesday that would balance the budget in nine years — but only by making large cuts to entitlement programs, including Medicare, that President Trump vowed not to touch.
The House Budget Committee is aiming to pass the blueprint this week, but that may be as far as it goes this midterm election year. It is not clear that GOP leaders will put the document on the House floor for a vote, and even if it were to pass the House, the budget would have little impact on actual spending levels.
Nonetheless the budget serves as an expression of Republicans’ priorities at a time of rapidly rising deficits and debt. Although the nation’s growing indebtedness has been exacerbated by the GOP’s own policy decisions — including the new tax law, which most analyses say will add at least $1 trillion to the debt — Republicans on the Budget Committee said they felt a responsibility to put the nation on a sounder fiscal trajectory.
“The time is now for our Congress to step up and confront the biggest challenge to our society,” said House Budget Chairman Steve Womack (R-Ark.). “There is not a bigger enemy on the domestic side than the debt and deficits.”
The Republican budget confronts this enemy by taking a whack at entitlement spending. Lawmakers of both parties agree that spending that is not subject to Congress’s annual appropriations process is becoming unsustainable. But Trump has largely taken it off the table by refusing to touch Medicare or Social Security, and Democrats have little interest in addressing it except as part of a larger deal including tax increases — the sort of “Grand Bargain” that eluded President Barack Obama.
The House Republican budget, titled “A Brighter American Future,” would remake Medicare by giving seniors the option of enrolling in private plans that compete with traditional Medicare, a system of competition designed to keep costs down but dismissed by critics as an effort to privatize the program. Along with other changes, the budget proposes to squeeze $537 billion out of Medicare over the next decade.
The budget would transform Medicaid, the federal-state health-care program for the poor, by limiting per capita payments or allowing states to turn it into a block-grant program — the same approach House Republicans took in their legislation that passed last year to repeal the Affordable Care Act (the repeal effort died in the Senate, but the GOP budget assumes that the repeal takes place).  It also proposes adding work requirements for certain adults enrolled in Medicaid. Changes to Medicaid and other health programs would account for $1.5 trillion in savings.
Social Security comes in for more modest cuts of $4 billion over the decade, which the budget projects could be reached by eliminating concurrent receipt of unemployment benefits and Social Security disability insurance.
The budget also proposes a number of other cost-saving measures, some of which could prove unpopular if implemented, such as adding more work requirements for food-stamp and welfare recipients and requiring federal employees — including members of Congress — to contribute more to their retirement plans. It assumes repeal of the Dodd-Frank Act that regulated banks after the financial crisis 10 years ago, something Congress recently rejected in passing a banking bill into law that softened some of the key provisions of Dodd-Frank but left its overall structures intact. And the budget proposes $230 billion in cuts from education and training programs, including consolidating student loan programs and reducing Pell Grant awards.
The budget also relies on rosy economic-growth projections and proposes using a budgetary mechanism to require other congressional committees to come up with a combined $302 billion in unspecified deficit reduction.
Overall, the partisan proposal is reminiscent of the budget released in 2011 by now-House Speaker Paul D. Ryan (R-Wis.), who was then the Budget Committee chairman and advanced a bold proposal attacking entitlements, slashing spending — and creating lines of attack for Democrats once Ryan became Mitt Romney’s vice presidential running mate on the GOP ticket the following year.
Democrats were quick to criticize the GOP proposal while contending that Republicans were opening themselves up to election-year attacks by releasing it at all.
“The 2019 Republican budget scraps any sense of responsibility to the American people and any obligation to being honest,” said Rep. John Yarmuth (Ky.), the top Democrat on the Budget Committee. “Its repeal of the Affordable Care Act and extreme cuts to health care, retirement security, anti-poverty programs, education, infrastructure, and other critical investments are real and will inflict serious harm on American families.”

Medicare Allows More Benefits for Chronically Ill, Aiming to Improve Care for Millions

by Robert Pear - NYT - June 24, 2018


WASHINGTON — Congress and the Trump administration are revamping Medicare to provide extra benefits to people with multiple chronic illnesses, a significant departure from the program’s traditional focus that aims to create a new model of care for millions of older Americans.
The changes — reflected in a new law and in official guidance from the Department of Health and Human Services — tackle a vexing and costly problem in American health care: how to deal with long-term illnesses that can build on one another, and the social factors outside the reach of traditional medicine that can contribute to them, like nutrition, transportation and housing.
To that end, the additional benefits can include social and medical services, home improvements like wheelchair ramps, transportation to doctor’s offices and home delivery of hot meals.
The new law is a rare instance of bipartisan cooperation on a major policy initiative, embraced by members of Congress from both parties. The changes are also supported by Medicare officials and insurance companies that operate the fast-growing Medicare Advantage plans serving one-third of the 60 million Medicare beneficiaries.
“This is a way to update and strengthen Medicare,” said Senator Ron Wyden, Democrat of Oregon and an architect of the law, the Chronic Care Act, which was included in budget legislation signed recently by President Trump. “It begins a transformational change in the way Medicare works for seniors who suffer from chronic conditions. More of them will be able to receive care at home, so they can stay independent and out of the hospital.”
Half of Medicare patients are treated for five or more chronic conditions each year, and they account for three-fourths of Medicare spending, according to Kenneth E. Thorpe, the chairman of the health policy department at Emory University.
Under the new law and Trump administration policy, most of the new benefits will be reserved for Medicare Advantage plans, which will be able to offer additional benefits tailored to the needs of people with conditions like diabetes, Alzheimer’s, Parkinson’s disease, heart failure, rheumatoid arthritis and some types of cancer.
“This is a big win for patients,” said Seema Verma, the administrator of the Centers for Medicare and Medicaid Services.
Officials hope that combining social and medical services will produce better outcomes for patients and save money for Medicare.
“An inexpensive railing in the bath can avoid a fall that can cause a hip fracture and potential complications,” said David Sayen, who worked at the Medicare agency for 37 years.
Treatment for a broken hip, including hospital care and follow-up services, can easily cost Medicare more than $20,000, and the costs are much higher in some regions than in others.
Medicare plans could also reduce co-payments and deductibles for people who receive treatment for a particular medical condition from certain recommended doctors, hospitals or other health care providers.
Mr. Sayen said the new federal policy gave health plans “a whole new toolbox to address social determinants of health.”
Although Medicare Advantage plans will wield most of the tools, their experience will be useful to policymakers who want to extend similar benefits to people in the rest of Medicare.
Medicare Advantage plans must cover all the services that the original Medicare program covers except hospice care, and many offer extra benefits as well. Until now, the government has generally required each Medicare plan to offer the same benefits with the same cost-sharing to all beneficiaries.
The Trump administration has reinterpreted the “uniformity requirement” to allow different supplemental benefits for people with different medical needs. Congress went further and allowed Medicare officials to waive those requirements for patients with chronic illnesses.
Moreover, Congress allowed Medicare plans to offer a wider array of supplemental benefits to the chronically ill, eliminating the current requirement that the extra benefits must be “primarily health-related.”
John G. Lovelace, the president of government programs at UPMC Health Plan in Pittsburgh, said the extra benefits could include visits by a personal assistant to help with bathing and dressing; visits by a nurse or a pharmacist to make sure a Medicare beneficiary with a dozen prescriptions is taking the right medicines; and special supervised housing for a person with dementia who cannot be left alone.
John K. Gorman, a former Medicare official who is a consultant to many insurers, predicted rapid growth in the use of high-tech pill dispensing machines, remote monitoring of homebound people and telehealth services to connect patients with doctors hundreds of miles away.
The Chronic Care Act provides new financial incentives for the use of telehealth services, including coverage for stroke patients in traditional Medicare as well as Medicare Advantage.
Sue Nelson, a vice president of the American Heart Association, said these provisions “could help tens of thousands of stroke patients every year, increasing survival rates and reducing disability and the need for rehabilitation and nursing home care.”
Many hospitals do not have stroke experts readily available. But under the new law, Medicare will pay for consultation with a neurologist at a distant location, using special medical equipment for videoconferencing. The doctor can review CT scan images and recommend treatments, including the use of highly effective clot-busting drugs.
Dr. Lee H. Schwamm, the chief of stroke services at Massachusetts General Hospital, said Medicare could also pay neurologists to evaluate patients with stroke symptoms while they were in an ambulance. The doctors could then direct paramedics to the most appropriate hospital.
David M. Certner, the legislative policy director of AARP, the lobby for older Americans, said his group supports the idea of allowing greater coverage for supplemental benefits, including nonmedical services that can improve care. “We believe such coverage should be available under both Medicare Advantage and traditional Medicare,” he said.
Defining eligibility and limiting the scope of benefits in traditional Medicare could be a challenge. But Eva H. DuGoff, a health services researcher at the University of Maryland, said, “We can learn from Medicare Advantage plans which services have the most benefits for which populations.”
Sarah L. Szanton, a professor at Johns Hopkins University, developed an experimental program that provided 1,000 low-income Medicare beneficiaries with extra services, including several visits from a nurse, an occupational therapist and a handyman who did minor home repairs and modifications. These services, she said, saved Medicare an average of $22,000 over two years for each beneficiary, keeping people safe at home and avoiding hospital and nursing home admissions.
Hundreds of thousands of people miss doctor’s appointments each year because they do not have reliable transportation.
Lauren Belive, the director of federal government relations for Lyft, the ride-sharing service, said her company was eager to meet that need for Medicare patients.
Lyft formed a partnership last year with the Blue Cross Blue Shield Association to provide rides to people who have health insurance but no convenient way to get to doctors and clinics.
Nonprofit groups like Meals on Wheels are also prepared to play a larger role, not only delivering meals but also checking on the health and safety of frail older people and providing potentially useful clinical information to health plans.
“We can be the eyes and ears inside the home to observe if there’s a change in the condition of the seniors we serve,” said Ellie Hollander, the president and chief executive of Meals on Wheels America.
The Chronic Care Act was a bipartisan project from the start, conceived by Mr. Wyden and the chairman of the Senate Finance Committee, Orrin G. Hatch, Republican of Utah, working with Senators Johnny Isakson of Georgia, a Republican, and Mark Warner of Virginia, a Democrat.


How the Government Can Lower Drug Prices

by The Editorial Board - NYT - June 20, 2018


In Baltimore, the health commissioner, Dr. Leana Wen, uses a need-based algorithm to decide which emergency rooms, needle-exchange vans, E.M.T.s and opioid outreach workers receive the city’s limited supply of naloxone — and which don’t. The drug, which reverses overdoses, has saved some 14,000 Baltimore residentssince 2015. But its price has increased in recent years, by between 95 and 500 percent, depending on which version of the medication is being considered. Even with donations and discounts from drug makers, Dr. Wen says the city can’t afford all the naloxone it needs.
In Louisiana, the state secretary of health, Dr. Rebekah Gee, says that officials must weigh the number of hepatitis C patients they could cure with new medications against a host of other priorities, like infrastructure and universal preschool. The drugs’ list prices run from $26,400 to $96,000 per person. Roughly 2.7 million Americans suffer from hepatitis C, a painful, often deadly infection spread mainly through injection drug use; roughly 20,000 of them are Louisiana residents who receive health care through state-funded programs. Even with various discounts, Dr. Gee says she cannot treat everyone on the state’s rosters.
Such calculations are being made everywhere, and not just because of the opioid crisis. Twenty-somethings fresh off their parents’ health insurance are rationing insulin; seniors are choosing between heart medications and groceries. Lives are laid to waste as cures stand at the ready.
One possible solution involves an obscure part of federal law known as Section 1498. The provision acts as a sort of eminent domain for patented inventions, allowing the government to circumvent patent protections as long as the patent holder is fairly compensated. In the case of a pharmaceutical, the Department of Health and Human Services can authorize a drug maker to produce a low-cost generic version, which it could then buy in bulk. Both Dr. Gee and Dr. Wen have asked the government to consider invoking the law to address the twin epidemics of opioid overdoses and hepatitis C.
In the late 1950s and 1960s, the federal government routinely used 1498 to obtain vital medications at a discount. According to a paper in The Yale Journal of Law and Technology, it enabled the Department of Defense to save a total of $21 million on 50 drugs in one three-year period.
But the law fell out of use, some say as a result of the pharmaceutical industry’s growing influence on Capitol Hill. In 2017, drug makers deployed 882 lobbyists and spent more than $171.5 million, thwarting efforts to lower prescription drug prices.
President Trump campaigned on a promise to “negotiate like crazy” to reduce the cost of prescription drugs by “billions and billions and billions” of dollars. Such boldness has been conspicuously absent since he took office. Mr. Trump has taken no steps to negotiate prices with drug companies, and neither he nor his health and human services secretary, Alex Azar, have expressed interest in 1498. Meanwhile, pharmaceutical stocks are soaring.
The administration’s own opioid commission has advised the government to negotiate with drug companies to cut naloxone prices. Surgeon General Jerome Adams has issued a public health advisory — the first one since 2005 — urging opioid users and their loved ones to buy naloxone and keep it within reach. Most states have taken steps to make the drug easier to get, but availability is still a significant problem, largely because of cost.
The National Academies of Sciences, Engineering and Medicine recently concluded that “unrestricted mass treatment” of hepatitis C would eliminate the disease as a public health problem by 2030. Independent experts convened by Johns Hopkins University said that if drug makers resist other options, 1498 would be a good way to accomplish that.
As Mr. Azar might remember, even the threat of a patent override can be a powerful motivator for an industry that lives and dies by its patent protections. He worked at the Department of Health and Human Services in 2001, when the nation was staring down an anthrax scare and his then-boss, the department’s secretary, Tommy Thompson, threatened to invoke Section 1498 to procure tens of millions of doses of the antibiotic ciprofloxacin. No need: Within days, the drug’s maker, Bayer, reduced the price voluntarily.
Drug makers argue that high drug prices and strong patent protections are essential to spurring innovation and are justified by the high costs of drug development. But both naloxone and several of the new hepatitis C drugs were developed, at least in part, with government-funded research. Companies that make these drugs have either recouped their investments many times over or are on their way to doing so.
And, in any case, negotiations don’t have to be zero sum. There is a way for both sides to win.
For example, if the government used the prospect of 1498 to get drug makers to the negotiating table, other potential solutions could then be worked out. One possibility is a subscription model, where a state or federal entity pays a fee for as much of a given medication as it needs. The fee would be far less than the original per-patient cost, but the company could then sell that many more doses. The government would save money, and the companies would gain an additional source of profit. Pharmaceutical companies use similar strategies to sell products in developing countries; there’s no reason the approach can’t work here.
But the federal government has to use its power to summon the drug industry to the table. Surely that couldn’t be difficult for an administration that has relished getting tough with groups far more vulnerable than Big Pharma.

Why Competition Won’t Bring Down Drug Prices

by Elizabeth Rosenthal - NYT - June 21, 2018



Martin Shkreli is in prison, but Daraprim still costs $750 per pill. Heather Bresch was hauled before Congress, but EpiPens still cost three to six times more than they did in 2007. Every week we hear of a new outrageous drug price hike. In polls, some 80 percent of Americans say that government should do more to curb drug prices.
Having proclaimed just before his inauguration that drug makers were “getting away with murder,” President Trump last month issued a 50-point blueprint to bring down prices, mainly by injecting more competition — and a dose of public shaming — into the market.
Though the document was light on specifics (containing more than 130 questions), the blueprint included proposals for speeding the development and sale of generics, increasing insurers’ negotiating clout, and making pricing more transparent.
The administration apparently hopes that, with a nudge and prod, the market will control pharmaceutical pricing excesses. If history is a guide, it won’t.
Competition may work well to affect the prices of baguettes and cars. But it has proved to have limited impact on American health care, especially when it comes to expensive interventions like prescription drugs.
Exhibit A would be Novartis’s cancer drug Gleevec, a miracle when it was approved by the Food and Drug Administration in 2001. It turned a deadly form of leukemia into a treatable disease. (Notably, Dr. Brian Drucker, the researcher who demonstrated that the drug could cure cancers, never got a patent and never made money from it.) Today, people who are in remission after two years of taking the drug have a normal life expectancy.
When Gleevec first came on the market, its list price was about $26,000 a year. Today, there are several highly-effective drugs in the same family on the market (sometimes called “sons of Gleevac”). The list price for each is about $150,000 annually.
What happened is that each new entrant cost more than its predecessors, which then also increased their prices to meet the higher price point. When the first generic version entered the market in 2016, its list price was only slightly less, about $140,000.
This phenomenon, what economists call “sticky pricing,” is common in pharmaceuticals. It has raised the price of drugs for serious conditions including multiple sclerosis and diabetes, even when there are multiple competing drugs.
The problem is that companies have decided it is not in their interest to compete.
In situations where there can be only one winner, competing is a given. But a lot of life and a lot of business just isn’t like that, especially when a group of companies are all doing good business by selling a type of drug for a very high price. There’s cover in numbers.
When you’re driving on the highway where a speed limits is 55 and most everyone’s going 70, you’re likely to increase your speed, too. Why should you feel bad? Why would the cop pick you? Someone else in a flashy car is probably doing 90. (For drug makers, Mr. Shkreli would be the hot-dogger who gives others cover.)
The parties are not really colluding. They’re not calling one another up to agree to drive too fast; no manufacturer (one hopes) is sitting at a country club agreeing to keep his prices high. This makes drug makers difficult to prosecute under racketeering or restraint of trade laws.
And shaming is in the eye of the beholder. The companies’ “stakeholders” are not really, after all, patients, but shareholders, who most likely will support the company in its attempts to make as much money as possible.
But while drug prices in America are going up, many of the same drugs are cheaper — and often coming down in price — in other developed countries, where governments step in to regulate prices.
These countries conduct large-scale negotiations to set a national price or price ceiling that its government or hospitals or citizens will pay — a kind of speed limit. Some stipulate that prices decline as a drug ages. (Now you know why Novartis might have paid $1.2 million to Michael Cohen, the president’s personal lawyer and “fixer,” after hearing the candidate’s threats.)
This is true of countries that have a national health system and those that do not. And price regulation can coexist with that American value, competition.
Armed with an assessment of a drug’s utility, Britain’s National Health Service sets a price it is willing to pay pharmacists for medicines they dispense. The pharmacists, who are in business for themselves, can then source the medicine from any wholesaler. The cheaper they can procure the medicine, the more they profit. Patients pay only a small portion of the cost and there is overview to correct for “market failure” — a situation in which pharmacies are making too much or too little from this arrangement.
Noting the far higher drug prices in the United States, the Trump administration has falsely accused other countries of “freeloading” on America’s investment in drug development. One of the questions in its blue print is: “What can be done to reduce the pricing disparity?”
If those 50-points don’t work once the 130-plus questions are answered, perhaps our government will conclude, as others have, that we, too, need some speed limits.
Elisabeth Rosenthal, a former New York Times correspondent, is the author of “An American Sickness: How Healthcare Became Big Business and How You Can Take It Back,” and editor in chief of Kaiser Health News.

Diabetes Patients at Risk From Rising Insulin Prices

by Randi Hutter Epstein and Rachel Huddle - NYT - June 22, 2018


A surprisingly large number of people with diabetes are using less insulin than prescribed because of the rising cost of the drug, putting themselves in danger of serious complications. Those are the findings of a small new study by researchers at Yale University, who found that at one clinic in New Haven, Conn., one in four patients admitted to cutting back on insulin use because of cost.
Everyone with Type 1 diabetes needs to take insulin, while about a third of those with Type 2 diabetes do. Not getting enough insulin can have severe consequences for someone with diabetes who does not produce enough of the hormone, which regulates levels of glucose in the blood. Within a week or so without insulin, people with Type 1 diabetes die. 
Between 2002 and 2013, the price of insulin jumped, with the typical cost for patients increasing from about $40 a vial to $130. The amount of insulin a person needs varies, but one vial typically lasts about a week or two.
The Yale team launched the recent study to assess how many people are affected by the rising prices. They surveyed 199 patients in the New Haven area who had either Type 1 or Type 2 diabetes, asking them six questions about their ability to afford insulin, including “Did you use less insulin than prescribed because of cost?” and “Did you not fill an insulin prescription because of cost?” A positive response to any of the six questions counted as insulin underuse. 
The researchers also used medical records to determine participants’ HbA1c level, a measure of blood sugar control. Unsurprisingly, those who reported underusing insulin because of cost were more likely to have dangerous blood glucose levels compared with those who said they did not underuse. 
Patients who reported an income between $25,000 and $100,000 were more likely to be cutting back on insulin compared with those who said they earn over $100,000. Darby Herkert, one of the study’s leading investigators who worked on the study while an undergraduate at Yale, suspects that middle-income patients are often hit hardest because they are ineligible for Medicaid, the government insurance program for the poor, but do not earn enough to afford better health insurance or pay out of pocket for insulin. She presented the findings at the American Diabetes Association Scientific Sessions on Friday in Orlando, Fla.
The new study focused on a single clinic, but researchers said it likely reflects what is happening nationwide. 
Last year, Alec Raeshawn Smith, who had Type 1 diabetes, reduced his insulin dosage to stretch out his medicine. He was 26 and had recently been removed from his parent’s insurance plan. Mr. Smith was found dead in his home in Minneapolis last June.
His mother, Nicole Smith-Holt, said he had been shopping for health plans but could not find one he could afford. When he went to pick up his insulin and glucose strips, he was told it would cost $1,300.
“He realized maybe too late, or he never realized he was in such danger and couldn’t make a rational decision to even call for help,” she said. 
Sara Theeler, a 41-year-old mother of three in Akron, Iowa, with Type 1 diabetes said she started rationing insulin after her divorce in 2010, when she lost her health insurance. She cut back on insulin and tried to manage her blood sugar levels by eating less. 
“I was hospitalized every couple of months with an infection on my foot and hand,” said Ms. Theeler. She had to have hand surgery when her uncontrolled sugar levels led to serious infections. She recently lost her job and is now on Medicaid, making insulin more affordable. 
Unlike many other drugs, there are no generic versions of insulin. Since the 1980s, drug makers have tweaked various versions of the drug that act for either a short or long duration, patenting these innovations along the way. Without competition among generics, prices have skyrocketed.
In the past decade, a global network of patient activists pushed for legislation to reduce the cost of diabetes treatment. This June, The American Medical Associationissued a statement calling for price transparency and for the Federal Trade Commission and the Justice Department to monitor insulin pricing.
A spokesman for Eli Lilly, which makes the drug, said that the firm offers several reimbursement plans, but some patients do not have good options because they do not have insurance or they have health plans with high deductibles.
Kristin Sikes, a pediatric endocrine nurse at Yale University, said the situation has gotten worse in the last five years. “Families are making decisions,” she said. “Do I feed my family or stretch the bottle of insulin as long as possible?”

A Drug Costs $272,000 a Year. Not So Fast, Says New York State.

by Katie Thomas - NYT - June 24, 2018


A wave of breakthrough drugs is transforming the medical world, offering hope for people with deadly diseases despite their dizzying price tags.
But what if it turns out that some of these expensive new drugs don’t work that well?
That’s the quandary over Orkambi, a drug that was approved in 2015 for cystic fibrosis and was only the second ever to address the underlying cause of the genetic disease. Orkambi, which is sold by Vertex Pharmaceuticals, costs $272,000 a year, but has been shown to only modestly help patients.
Now, in a case that is being closely watched around the country, New York state health officials have said Orkambi is not worth its price, and are demanding that Vertex give a steeper discount to the state’s Medicaid program. The case is the first test of a new law aimed at reining in skyrocketing drug costs in New York’s Medicaid program.
The high price of prescription drugs has ignited a populist furor, and in May, the Trump administration unveiled a set of proposals to address the issue. But while the ideas at the federal level are still mostly theoretical, some states have begun tackling the issue themselves. Earlier this year, Massachusetts asked the federal government for permission to limit its coverage of drugs in an effort to secure larger discounts from drug makers. Other states, like California and Vermont, have passed laws requiring drug companies to turn over certain financial details if they raise prices significantly.
“There’s a number of states that are really trying to push forward and say, we need to be thinking very differently about how we’re paying for drugs,” said Matt Salo, the executive director of the National Association of Medicaid Directors. “We need the ability to say that there are some drugs that are just not priced in a rational way.”
Orkambi held great promise for people with cystic fibrosis when it was approved three years ago. A similar drug, Kalydeco, approved in 2012, was viewed as groundbreaking because it was the first to try to counteract the genetic defect that causes cystic fibrosis. The disease, which affects about 30,000 Americans, leads to a buildup of sticky mucus in the lungs and can lead to death by respiratory failure by the time many people are 40. 
But while Kalydeco, also known as ivacaftor, was found to be effective, it was only approved for a sliver of patients with the disease — those who had certain genetic mutations. Orkambi, which combines ivacaftor and another drug, lumacaftor, was approved for mutations that covered nearly half of cystic fibrosis patients, but studies showed it was not as effective as Kalydeco. 
More coverage of cystic fibrosis drugs
Since Orkambi’s approval, several countries have balked at paying for it, including Britain, France and Canada. 
In the United States, private insurers and Medicare plans have generally covered Orkambi. Medicaid programs, which cover health insurance for the poor, are required to cover all drugs.
Still, many insurers require patients to pay thousands of dollars out of pocket, and even though Vertex offers assistance, not everyone qualifies. 
Lora Moser, 40, is covered by Medicare because she is disabled, and said she had to stop taking Orkambi in January because she could not afford the first month’s payment of more than $3,000 required by her insurer, Humana. A spokeswoman for Humana said that for high-cost drugs like Orkambi, the insurer helps patients identify outside assistance programs to cover out-of-pocket costs.
A nonprofit group that had provided assistance the previous year to Ms. Moser declined to renew her grant because, she said she was told, her annual household income was too high. She said her income is about $600 above their limit. 
“I’ve never felt more destitute and hopeless as I do right now, from a medical standpoint,” Ms. Moser said. 
A spokeswoman for Vertex, Heather Nichols, said more than 99 percent of cystic fibrosis patients who are eligible to take Orkambi in the United States have “broad access” to the drug. 
“Vertex has a longstanding commitment to supporting access for all eligible patients, and we will continue to oppose any attempts to restrict patient access to these transformative medicines,” Ms. Nichols said.
Despite its lukewarm reception, Orkambi has been a boon for Vertex. In 2017, the drug was its top-selling product, bringing in about $1.3 billion in sales, a considerable sum for a product that is only approved to treat about 28,000 people worldwide. 
Dr. Steven D. Pearson, the president of the Institute for Clinical and Economic Review, which evaluates the cost-effectiveness of drugs, said the problem is that in the United States, drug companies control the prices, especially in the case of newly approved drugs like Orkambi. 
“Our system is set up not to distinguish very well between those drugs that are fairly priced and those that are not,” he said. Dr. Pearson’s institute concluded that Vertex’s cystic-fibrosis drugs should be discounted by as much as 77 percent. “That gives the incentive to the company to overreach, and that’s part of why our system is so out of whack,” he said.
In April, Orkambi became the test case for the New York law when a state board ruled that the drug was not worth its cost, recommending that it be discounted from the list price by roughly 70 percent — an amount that was influenced by work done by Dr. Pearson’s institute. New York’s law, passed in 2017, allows the state to ask manufacturers for a deeper discount if the state’s Medicaid drug budget exceeds a certain amount.
Under federal law, state Medicaid programs get a rebate of at least 23 percent. New York officials said that they identified 30 drugs this year that were priced too high, and that those products’ manufacturers agreed to deeper discounts, resulting in about $60 million in annual savings. Vertex, which is based in Boston, was the only company that refused, the state said. New York officials did not identify the manufacturers that agreed to steeper discounts.
For now, at least, Vertex appears to have the upper hand because federal law requires the state to cover Orkambi, although the state can limit its use. Under its new law, New York could also demand that Vertex disclose details about how it sets its price, including how much goes toward research and development or to other areas, like marketing. But even if Vertex complied, that information would not be made public because it is considered proprietary.
Ms. Nichols, the Vertex spokeswoman, said the company had no plans to agree to a discount below the 23 percent required by law. 
And Donna Frescatore, the director of New York’s Medicaid program, said she was reluctant to limit the use of Orkambi for those who need it. “It’s certainly a balance with our ability to get fair pricing for this medication,” she said.
But despite the impasse, Mr. Salo said big states like New York are major buyers of prescription drugs, and companies may see an interest in taking those states seriously. “I see this as being of very, very widespread interest,” he said. “A lot of other states are kind of watching and saying, ‘How is that going to work?’”
The debate over Orkambi may soon become moot — earlier this year, the Food and Drug Administration approved a new cystic fibrosis drug, also made by Vertex. Symdeko, as the drug is called, treats a similar population as Orkambi, but has been proven to be more effective. It carries a list price of $292,000 a year, and some analysts, including Geoffrey Porges, of Leerink, say they believe Symdeko will eventually replace Orkambi.
Given the arrival of Symdeko, some analysts said New York would be smart to negotiate a package deal for all three of Vertex’s cystic fibrosis drugs, similar to a deal recently made with Ireland. Ms. Frescatore said that’s an approach that she would consider. 
“You don’t want a patient being forced to take Orkambi because it’s cheaper,” Mr. Porges said. “You want the right patient to get the right medicine.”
Maine Legislature approves funds for Medicaid expansion opposed by governor
by Scott Thistle - Portland Press Herald - June 21, 2018

AUGUSTA — Both houses of the Maine Legislature have voted to approve funding to extend Medicaid to an estimated 70,000 residents, potentially undercutting Gov. Paul LePage’s argument against implementing the voter-approved expansion.
In a separate action Wednesday, the Maine Supreme Judicial Court granted LePage’s request to stay a lower court’s orderthat would have required him to immediately submit an expansion plan to the federal government.
In Augusta, the Senate and House agreed on a plan to pay for the state’s estimated $60 million share of costs associated with Medicaid expansion in Maine and sent the bill to LePage’s desk.
In November, voters approved expanding Medicaid by a margin of 59 percent to 41 percent. The expansion will open up the program to Mainers who earn 138 percent of the federal poverty level – $16,753 for an individual or $34,638 for a family of four. The change would expand the system to an estimated 70,000 Mainers, although critics of the expansion say it could increase the state’s Medicaid rolls by as much as 80,000.
REALIGNING FUNDING SOURCES
LePage has repeatedly blocked Medicaid expansion through legislation, and after voters approved it in a referendum he has refused to implement it, arguing that the Legislature must first allocate funding.
There are conflicting assessments about how much the expansion will cost the state even with the federal government footing 90 percent of the bill. A recent study funded by the Maine Health Access Foundation estimated it will cost roughly $30 million in the current two-year budget, but the LePage administration has pegged the costs at $60 million during the first year and as much as $100 million annually in future years.
While both houses support a roughly $60 million allocation if needed, the Senate voted 23-9 Wednesday to amend a bill approved Tuesday by the House. The amendment calls for funding the expansion using $31 million in surplus funds and up to $23.5 million of the additional money that the state received from a lawsuit settlement with tobacco companies, and excludes the proposed use of about $20 million from the state’s budget stabilization account, known as the “rainy day” fund.
https://www.pressherald.com/2018/06/20/bill-to-fund-medicaid-expansion-in-maine-amended-to-use-tobacco-settlement-funds/

Here’s how Maine’s ballot question on universal home care will read

by Dennis Hoey - Portland Press Herald - June 26, 2018

A group opposing Question 1 argues that the initiative, which would raise taxes on wealthy Mainers to pay for home care for the elderly and disabled, violates the Maine Constitution.

The Maine Secretary of State’s Office released on Monday the language of a November ballot initiative that would raise taxes on wealthier Mainers to pay for home care for the elderly and disabled.
Secretary of State Matthew Dunlap said in a press release said that the final wording of the question on an act that would establish universal home care for seniors and persons with disabilities was based on feedback from the public, who had until June 15 to offer comments.
Dunlap said the initiative proposed by the Maine People’s Alliance will read as follows: “Do you want to create the Universal Home Care Program to provide home-based assistance to people with disabilities and senior citizens, regardless of income, funded by a new 3.8 percent tax on individuals and families with Maine wage and adjusted gross income above the amount subject to Social Security taxes, which is $128,400 in 2018?”
An opposition group announced Monday that it will launch a campaign urging Maine voters to vote against the 3.8 percent income surtax, which will appear as Question 1 on the statewide ballot Nov. 6.
NO on Question 1 said it will officially kick off its campaign against the initiative during a news conference beginning at 10:30 a.m. Tuesday at the VNA Home Health Hospice, 50 Foden Road in South Portland.
The opposition coalition said in a release that home care, health care, business leaders, advocates and representatives “who oppose the 3.8 percent surtax to fund a new government program to provide home care for seniors and people with disabilities” will attend.
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During a news conference at the State House in Augusta in May, opponents of Question 1 argued that the referendum question violates the Maine Constitution and federal privacy laws.
Former Maine Supreme Judicial Court Chief Justice Daniel Wathen called the referendum “deeply unconstitutional in many respects.”
And Dana Connors, president of the Maine State Chamber of Commerce, said, “It over-promises and under-delivers, while at the same time creating chaos to our economy by pushing a tax rate for many to nearly 11 percent.”
The Maine People’s Alliance says the referendum would only apply to the wealthiest 1.6 percent of Mainers and argues that the issue of affordable home-based care is important because of Maine’s aging population.

When a Health Insurer Also Wants to Be a Hospice Company

by Reed Abelson - NYT - June 22, 2018


Death has always been lucrative enterprise, whether it involves mahogany caskets or teams of estate and tax lawyers. But hospice, the business of caring for those who are nearing death, has become a booming multibillion-dollar industry that is attracting more and more for-profit companies, including one of the nation’s major insurers. 
That insurer, Humana, is making an unusual bet beyond the current strategy of health insurers to merge with pharmacies or buy up doctors’ practices. In teaming up with two investment firms, Humana plans to buy two hospice chains that together would create the industry’s biggest operator with hundreds of locations in dozens of states. 
Humana, which specializes in offering private Medicare Advantage plans, joined forces with TPG Capital and Welsh, Carson, Anderson & Stowe, two private-equity firms, last December to take over a division of Kindred Healthcare that offers both home health and hospice care. In April, the same group said it planned to buy another large hospice outfit, Curo Health Services, owned by another investment firm, Thomas H. Lee Partners. 
In short, Humana, which provides Medicare Advantage plans to about 3 and a half million people for their medical needs, also wants to dominate care for those at the end stages of life, whether it provides aid in a home setting or in a facility. 
But a spate of government lawsuits charging negligence and malfeasance against some hospice providers underscores the risks of profiting from the dying: Companies have been accused of signing up people who are not terminally ill, denying visits from a nurse or even refusing a needed trip to the hospital. 
While people getting hospice care may be at less risk for getting medical tests and treatments they do not need or want, they could get too little care, said Dr. Joan Teno, a professor of medicine and a health services researcher at the Oregon Health & Science University. The danger when a profit-driven company is delivering care is “the focus is more on profits than on quality,” she said. 
“We need to make sure quality is front and center,” she said. 
Humana’s decision to purchase the two hospice outfits puts it squarely in the middle of the debate. Both of the companies it plans to acquire have been embroiled in lawsuits brought by the federal government accusing them of, in one case, overbilling Medicare and, in another, paying doctors and nurses illegal kickbacks to refer patients to hospice.
Medicare has largely driven the recent interest in hospice, spending about $17 billion on such care in 2016, the most recent figure available. The program covering health care for people 65 and over began paying for hospice in 1983, a time when many people at the end of life were forced to spend their last days in a hospital bed, receiving expensive but futile treatments. To allow people to die more comfortably at home, the program started services like nursing care and a home health aide for people with a life expectancy of six months or less. People typically agree to stop treatments aimed at curing their disease in favor of care that makes them more comfortable.

‘A Pretty Profitable Business’ 

Hospices are paid a fixed amount per day and are expected to oversee the care of someone with a terminal illness, including home visits, medicines to control pain and trips to a specialist or hospital if needed. While a hospice is paid about $150 to $200 a day for routine care, they can get paid nearly $1,000 a day if someone needs round-the-clock services. Patients can stay in hospice as long as doctors agree they remain terminally ill.
Providing hospice care can be a “pretty profitable business,” said Emily Evans, a managing director for Hedgeye Risk Management, a research firm. She estimates some private companies make as much as 40 cents of profit for every dollar of revenue they take in, an extremely high profit margin of 40 percent. The Medicare Payment Advisory Commission, which does research for Congress, estimates that for-profit companies running hospices, which make up about two-thirds of the industry, had an overall profit margin of 16 percent, compared to about break-even for nonprofits. 
Many hospice outfits have been sued by the government, accused of overbilling Medicare by enrolling patients who did not qualify, or for stinting on care. Last year, the Department of Justice settled a lawsuit against one company, Chemed, for $75 million. Chemed, a public company, also owns Roto-Rooter, the plumbing and drain cleaning business.
Government officials had accused Chemed and its hospice unit, Vitas, of aggressively billing Medicare for “crisis care,” even when patients did not require intensive services. One nurse who worked for Vitas described being sent to patients’ homes during a so-called crisis only to find the patients “were at church, the beauty parlor, or playing bingo.” Vitas, which was the nation’s largest hospice chain at the time, went ahead and billed for crisis care, according to the government’s lawsuit. 
In one particularly egregious case, a hospice outfit in Texas has been accused by the federal government of giving patients unnecessarily high doses of medication that may have led to some deaths. Earlier this month, a nurse case manager pleaded guilty in the case, acknowledging that she collected unused medications like morphine from patients who had died to administer to other patients, and admitted to helping overmedicate some patients to hasten their death. 
Kindred, whose hospice business Humana hopes to buy, was penalized $3 million in 2016 by federal officials and closed some facilities after the government said it could not ensure that it was not overbilling Medicare. The hospice outfit now owned by Kindred had paid $25 million in penalties in 2012 to settle accusations of improper billing.
Curo, the other hospice business, has also had its share of run-ins with federal officials. Last year, it paid $12 million to settle accusations that it handed out kickbacks to reward doctors for sending patients to its hospices.
Even UnitedHealth Group, the nation’s largest health insurer with fingers in a number of pies like doctors’ practices, free-standing surgery clinics and urgent care centers, sold its hospice business in 2016, the same year it settled a case with the Justice Department
United’s hospice unit, known as Evercare, was accused of enrolling patients who did not qualify, setting “aggressive census targets” for enrollment and paying employees bonuses if they met those targets. The company employed a team to “troll nursing homes, hospitals and other care facilities to obtain new Evercare hospice patients,” the Justice Department said. 
The flood of lawsuits has discouraged some companies from getting into this field. “There’s a lot of risk,” said Paul Keckley, an independent health care analyst. 
But Ms. Evans contends that “the margin may well be worth the headline risk.” The federal government doesn’t seem to have “a good plan or an aggressive plan” in prosecuting some of the bad behavior that takes place, she said.

Cutting Staffing and Services

The potential for great profit margins has certainly caught the eye of bigger businesses. While local nonprofit groups used to provide services, much of the hospice care now available is dominated by companies that may seek higher profits even if that involves enrolling patients who don’t need such care, or cutting staff and services to bare levels.
For-profit companies tend to argue they are more efficient and can invest in the people and technology to provide better care for dying patients, especially at home. Humana and the two investment firms declined to comment because they have not yet completed the purchases. 
Humana has a significant interest in being able to better manage people in their Medicare Advantage plans, which are private insurance plans for people enrolled in Medicare who do not want to be in the traditional program where the government pays doctors and hospitals directly for their care. Its proposed merger with Aetna, another giant insurer, was blocked last year after the Justice Department claimed it would harm consumers.
Analysts say any insurer offering a Medicare Advantage plan would benefit in seeing patients opt for hospice, rather than continue much more costly treatments at the end of life. Under the current system, the federal government pays for all of the costs for anyone who is in hospice. If a patient does not enroll in hospice and stays in a Medicare Advantage plan, the insurer remains responsible for all of the medical bills. 
An insurer that can steer patients toward its hospice has “better control,” said Rob Smith, an analyst with Capital Alpha Partners. After giving consent, dying patients can be shifted to the hospice program, and while an insurer would lose out on money it received from Medicare to cover that person, a company like Humana could count on the revenue generated by its hospice business. “Your other pocket is filled by Medicare,” he said.
The hospice business has “a pipeline coming from Medicare Advantage,” said Ana Gupte, a senior health care analyst at Leerink Partners. “There is a clear synergy from a top- and bottom-line perspective,” she said. 
Home health care, including hospice, is a critical component of Humana’s strategy, analysts say, which is to offer an array of services for people as they age. The insurer may also be betting that hospice care in the home eventually becomes a part of what private Medicare plans must cover in the future. 
“Humana wants to own the home,” said Chas Roades, a founder of Gist Healthcare, a consultant, even at the end.

Gov. LePage floating idea of new hospital tax to fund Medicaid expansion

by Associated Press - June 25, 2018

AUGUSTA — Some lawmakers said Monday that Maine’s Republican governor has been floating a new tax on hospitals to pay for voter-approved Medicaid expansion.
Republican Senate President Mike Thibodeau said Gov. Paul LePage’s administration has sent word that the governor is considering the idea. LePage’s office didn’t respond to repeated requests for comment.
But it’s unclear whether lawmakers would get behind such an idea at this stage. Thibodeau said if formally proposed, such a tax hike would typically receive a public hearing.
Maine Hospital Association spokesman Jeffrey Austin said the idea would be opposed by Maine hospitals, which already pay $100 million in taxes each year.
Mainers voted last fall to expand Medicaid to over 70,000 low-income adults by July 2. But Medicaid expansion is on hold as LePage’s administration fights a lawsuit by advocates calling on the governor to stop blocking expansion.
Maine Equal Justice Partners Executive Director Robyn Merrill said the governor has had months to come forward with a spending plan.
“The Legislature came up with a plan and it’s sitting on his desk,” she said.
For months, LePage’s administration has argued that lawmakers must first appropriate money for expansion – under his terms, which includes no tax increases.
Lawmakers last week approved legislation directing up to $54.5 million in surplus funds and tobacco settlement money for expansion.

Editor's Note:

I received the following email from Robin Merrill, ED of Maine Equal Justice Partners, the NP primarily responsible for the successful referendum for expanding Medicaid in Maine. It speaks for itself.

-SPC

Logo - display images to see it
In case you missed it, LePage is blaming Maine Equal Justice (and me personally) for his Administration’s failure to take steps to implement the law the voters passed last November. See Medicaid Expansion Activists Will Hurt People Who Need Help Just To Prove a Point:  https://www.maine.gov/governor/lepage/newsroom/weekly-address.html
The Governor claims that Maine Equal Justice created the chaos that will result when people who are now eligible apply on July 2nd.  To be clear, any problems that result are problems of their own making. DHHS has had since November to prepare for this and they have done nothing.
The good news is that the Legislature passed legislation providing funds equal to what the Governor claims to need to implement the law. The bill went to his desk Wednesday evening and his 10 days to veto will expire on July 2nd. He promises to veto the law but that does not square with his repeated claim to the court that once the legislature acts he is ready to enforce the law.
In the latest turn of events, at the 11th hour, LePage is threatening to stall on bonds for critical infrastructure unless lawmakers pull the Medicaid expansion bill from his desk and fund it with a hospital tax. http://mainepublic.org/post/governor-floats-hospital-tax-pay-medicaid-expansion. You can’t make this stuff up!
We will do everything we can to override this veto but regardless, this will likely need to be resolved by the court. Oral arguments are scheduled with the Law Court for July 18th.
We are going to get this done for the 70,000 people waiting for health care, and for the voters who passed the law. We will not back down and the Governor’s bullying tactics only work to bolster our resolve.
The end is now in sight and we’ll get there together.
Thanks for standing with us, and believing in democracy and the power of people!
Sincerely,
Robyn Merrill, Esq.
Executive Director






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