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Tuesday, August 2, 2016

Health Care Reform Articles - August 2, 2016

Frances Perkins and the Health Care Struggle  
Remembering the woman behind the New Deal
by Charles Hoffacker

In February 1933, Franklin Roosevelt and Frances Perkins met in Roosevelt's New York City home. The president-elect wanted his colleague in the New York state government to become the nation's Secretary of Labor. Perkins would not accept this position unless she could pursue the goals important to her. These goals were breathtaking.  The list included a minimum wage, maximum-hour laws, worker's compensation, unemployment compensation, a public employment service, public works, a child labor ban, health insurance, and old age pensions.
Over the course of the Roosevelt presidency, Frances Perkins achieved substantial success. She met all but one of these goals, health insurance. She and Roosevelt fundamentally reordered American society. However, efforts at establishing health insurance met with defeat. Opposition mobilized by the American Medical Association was so intense that it threatened the passage of the 1935 Social Security Act.
 
This was not the first battle the AMA had won against the Labor Department. Shortly before, the Children's Bureau of the Department had lost funding for a successful initiative to reduce maternal and infant deaths. The AMA opposed the initiative as an intrusion into private medical practice.
 
A generation later, on July 30, 1965, President Lyndon Johnson signed the Medicare and Medicaid Act which amended the Social Security Act. This new legislation initially provided health insurance for the elderly and the poor. It was, however, the result of a complex, torturous legislative history. Frances Perkins died two months before the bill was signed.
 
In his remarks at the signing, Johnson recognized numerous public officials who had contributed to the bill's passage. There was no mention of Frances Perkins. However, Johnson quoted Roosevelt, who described the 1935 Social Security Act as "a cornerstone in a structure which is being built but it is by no means complete." Johnson went on to say that "perhaps no single act in the entire administration of the beloved Franklin D. Roosevelt really did more to win him the illustrious place in history that he has as did the laying of that cornerstone."
 
Additional efforts to build on that cornerstone have continued, especially during the presidential administrations of Bill Clinton and Barack Obama. Concepts such as "universal health care" and a "single payer system" provoke debate.  Opponents of expanded health care include pharmaceutical and health insurance companies, fearing loss of profits or even their place in the national economy. Still, the battle rages to realize the final goal on the list that Frances Perkins presented to Franklin Roosevelt back in 1933.
 
The American people are increasingly aware that our country stands out as a scandalous exception in a world where numerous nations provide their people with a single payer health care system. The American people feel this scandal in a deeply personal way when they and their family members experience unnecessary suffering and die prematurely due to a lack of affordable medical care. While American medical technology is unsurpassed in the world, American health care delivery falls drastically short of a decent standard. People are often more concerned about paying for health care than they are about recovery from illness. 
 
Frances Perkins was a devout Christian who lived her faith through public service for the common good. What America needs now more than ever is a health care system that serves the common good rather than corporate profit.
 
Charles Hoffacker serves on the board of the Frances Perkins Center in Newcastle, Maine. An Episcopal priest since 1982, Charles is rector of St. Paul's Parish, Baden, Maryland.

Obama on Obamacare

President Obama’s new paper defending the Affordable Care Act only shows why we need single-payer health care

By Adam Gaffney, M.D.
Jacobin, July 26, 2016
"Obama on Obamacare” would have been a catchier title for “United States Health Care Reform,” the scholarly paper the president published in the Journal of the American Medical Association earlier this month. Garnering widespread coverage because of its novelty (“call him scholar-in-chief,” noted Fortune) and for its call for a “public option” to further improve the American health-care system, Obama’s article should interest us more for what it left out.
The president begins his review of the Affordable Care Act (ACA) with a brief discussion of its roots — including the profound shortcomings of the pre-ACA landscape — before proceeding with a largely rosy, albeit data-based, discussion of progress made under the law.
He splits his assessment into two categories — its expansion of insurance coverage, and its reforms of the “health-care delivery system.” Both show the limits of the recent attempts at reform and the broader Democratic Party political vision.
The Uninsured
As Obama fairly describes, the ACA resulted in a substantial decline in the number of uninsured Americans over the past five years. Using recently released figures, he cites a drop from 16 percent in 2010 (when the law was passed) to barely over 9 percent in 2015 (after its main provisions were implemented) — a change that amounts to around twenty million more insured people today as a result of the ACA.
Being uninsured is an obvious injustice. It squeezes the resources of those who can least afford it at the worst possible time, and it takes thousands of lives a year. A major reduction in the rate is a good thing.
But there  more to be said. First, Obama barely mentions the more than twenty-five million individuals who — it is estimated — will remain uninsured in the foreseeable future. Nor does he address the stark class- and race-based inequalities in uninsurance that remain.

“Health Insurance Coverage: Early Release of Estimates from the National Health Interview Survey, 2015,” National Health Interview Survey Early Release Program (2016). Note: Uninsured as defined at time of interview; see source for methodology.
While real universal health care will admittedly not resolve all health inequalities (which stem from many factors), a rudimentary first step would be to ensure that neither racenor class prevents patients from seeing a doctor.
A second point to be made about declining uninsurance is that it comes predominantly from the law’s Medicaid expansion: under the ACA, everyone whose income falls below 138 percent of the federal poverty level became eligible to enroll in Medicaid, although a 2012 Supreme Court decision allowed states to decline to participate.
In an editorial accompanying Obama’s article, Stuart Butler of the Heritage Foundation quips that the ACA might be better called the “Medicaid Expansion Act,” a development he sees as “troubling.” His orientation towards this aspect of the law is wrong, however: as the largest source of new insurance coverage, the ACA’s Medicaid expansion is actually its best provision.
However, while we no doubt should fight to implement Medicaid expansion in the nineteen states that have ruthlessly refused to (at the cost of much bloodshed), we should also bear in mind the program’s shortcomings, which Obama neglects.
Medicaid often provides good health-care access, but it can also become a lower-tier program for lower-income and disproportionately minority individuals. Thanks to Medicaid’s lower provider reimbursements, people enrolled in the program far too often cannot avail themselves of the same medical providers as those with private insurance or Medicare. It thus contributes to health-care segregation.
Similarly, those with narrow network plans — private insurance plans that limit them to particular providers and exclude them from prominent hospitals — also suffer. Again, Obama does not mention this problem in his paper.
One issue Obama does briefly address is the frequently heard critique that the ACA has bolstered the rise of health-care cost-sharing: the payment due at point of use that includes things like copayments, deductibles, and coinsurance. High cost-sharing means the underinsured frequently avoid going to needed doctor’s appointments, having important tests run, or even visiting the emergency room. When they do, they are often left with punishing bills.
While admitting that deductibles have been rising, Obama asserts that the rate of increase has not changed. But he misses the point: the argument isn’t that the ACA created “underinsurance” — it’s that it didn’t reduce it, much less eliminate it, which should be our real goal.
The Hidden HMO
The next section of Obama’s paper deals with how ACA reforms have changed the health-care delivery system. Though uninsurance and underinsurance more directly impact patients, this part of the law has massive ramifications for the overall political economy of health care. Obama notes:
Before the ACA, the health-care system was dominated by “fee-for-service” payment systems, which often penalized health-care organizations and health-care professionals who find ways to deliver care more efficiently, while failing to reward those who improve the quality of care.
He proceeds to discuss what is often referred to as “value-based” health care, a benign-sounding framework that is currently on track to restructure how the nation’s entire medical sector is financed.
Value-based health care might be best described as the “Great Wonks’ Hope” for health-care reform in the United States (and increasingly in high-income nations globally, where US policy innovations have huge influence). According to the Harvard Business Review, it “shift[s] the focus from the volume and profitability of services . . . to the patient outcomes achieved.”
The premise here — pay for quality, not quantity — seems commonsensical. And tellingly, value-based health care has even earned that ever-elusive bipartisan support. Its approach includes pay-for-performance (P4P) programs and encourages “alternative payment models” like accountable care organizations (ACOs). Both of these play a prominent role in the ACA.
P4P — “paying for results” — no doubt sounds exceedingly reasonable, particularly for anyone who has experienced poor, neglectful, or inhumane treatment. However, in both concept and practice, pay-for-performance threatens the health-care system in the same way such rubrics have been a disaster for American education.
In schools, financial incentives and disincentives are wielded to “encourage” (or, more accurately, to punish) teachers into raising their students’ test scores. Sometimes, this entails vicious mass firings based on algorithm-derived scores with dubious merit.
Though monitoring quality metrics is no doubt important, basing payment on performance metrics — which are determined by a multiplicity of factors outside the control of the doctor or hospital (or teacher or school) — is a technocratic solution to a complex problem that far too often penalizes those who care for the disadvantaged. This ultimately harms their patients (and students).
Doctors’ more privileged economic and political position — as compared to teachers — has thus far largely forestalled such measures’ implementation for the medical profession. Things may be beginning to change, however: under the Medicare Access and CHIP Reauthorization Act of 2015, passed with bipartisan support last year, a substantial portion of physicians’ Medicare reimbursement will soon be set by how they score on a variety of quality metrics — unless they join an ACO or something similar, where payment will be determined by both performance scores and spending.
Which brings us back to ACOs. As Obama notes, his administration’s goal has been to direct half of all Medicare reimbursements toward ACOs or similar “alternative payment models” by 2018. So what are ACOs, and why should anybody care?
“Some people say ACOs are HMOs [health maintenance organizations] in drag,” as one policy scholar told Jenny Gold of Kaiser Health News. Like HMOs, ACOs are organizations of hospital systems and/or physician practices that share risk with insurers, meaning that the medical providers financially benefit when they reduce spending on patient care.
There are admittedly differences, including P4P-type requirements that ostensibly help maintain the quality of care. But depending on how things go, some ACOs could prove as unpopular with the public as the corporate HMOs of the 1990s, which were widely (and correctly) perceived as exploitative penny-pinchers.
In any event, ACOs’ actual track record of significantly reducing costs is paltry: as Kaiser Health News recently reported, their net savings for Medicare has so far been a big zero.
Similarly, although Obama points to some positive examples, little evidence suggests that P4Ps have any effect on health-care outcomes. Just last week, for instance, a studypublished in the Lancet described how the biggest P4P program on the planet — which applied to nearly the entire United Kingdom, was funded at enormous cost, and provided large financial incentives — had no impact whatsoever on mortality among the conditions it specifically targeted.
Obama is excessively optimistic — in all fairness, like seemingly everyone else in the health policy community — that ACOs and P4P will take us to a value-based health-care promised land.
The Public Option?
As he gets closer to the end of his paper, Obama turns to calls for further reform. Some of these are entirely reasonable — though also entirely inadequate — but his return to a public option has received by far the most attention. Regardless of how one feels about the public option in theory, it’s worth acknowledging how entirely peripheral such a reform, at least as Obama describes it, would be in practice.
Obama asserts that the ACA’s marketplaces — the online “exchanges” where those who are otherwise uninsured buy so-called Obamacare plans — serve the vast majority of enrollees well, because competition among plans keeps premiums within a reasonable range. However, 12 percent of enrollees, he notes, reside in areas where only one or two insurers operate. In these areas, competition falters.
Enter the public option. Congress should consider, he states:
[A] public plan to compete alongside private insurers in areas of the country where competition is limited. Adding a public plan in such areas would strengthen the Marketplace approach, giving consumers more affordable options while also creating savings for the federal government.
In other words, this “public option” would have no impact on anyone currently insured through their employer, and a theoretical impact only for the tiny minority of Obamacare marketplace enrollees who reside in areas with fewer than three insurers.
Even there, its potential benefit is questionable for various other reasons, like the fact that a public option could become the refuge of the sickest. (If this were to happen, the public option would functionally subsidize the private insurance industry by taking on the more costly patients, becoming less and less affordable in the process).
Those hoping that the public option will deliver the dream of universal, equitable, and comprehensive health care with first-dollar coverage for all are set for the disappointment of their lives if — and when — such a public option is passed.
Finally, Obama takes a soft swipe at single payer, noting that its proponents — like conservatives who proclaim vouchers as the answer to everything — fail to see the value in a more balanced, public-private, American-style approach to public policy.
On the one hand, this isn’t quite fair: under single payer, though health-care funding would be basically entirely public, most care would still be delivered by private (albeit not-for-profit) hospitals and providers. On the other hand, his dismissal of single-payer is a loud and clear political message, reinforcing the Democratic Platform Committee’s recent, dismal rejection of the plan.
Their rejection is particularly galling because — according to a recent Gallup poll — an overwhelming majority (73 percent) of Democratic-leaning voters support single payer, together with some 58 percent of Americans overall.
It must be awkward for prominent liberals who disagree with said majorities. A policy idea that commands extremely strong support from their own base — and the public at large — has to be unironically declared a political impossibility, a pleasant-sounding but fanciful health-care castle in the sky. That they have been successful with this strategy so far says virtually nothing about single payer’s practicality or merits, and much about the anemia of American democracy.
Adam Gaffney is a physician whose work has appeared in Salon, Dissent, and In These Times. He blogs at theprogressivephysician.org.
https://www.jacobinmag.com/2016/07/obama-obamacare-aca-single-payer-health-hospitals/


 

Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing

by Gina Kolata - New York Times
Health regulators in the United States are talked about as the best in the world, but a new study on the spread of stem cell clinics shows what can happen when regulations fall behind.
Out of nowhere, over the past two to three years, the clinics have sprung up — 570 in the United States, according to a recent paper — offering untested stem cell treatments for just about every medical use imaginable.
In theory, stem cells might be a useful treatment for certain diseases that involve the loss of cells, like Type 1 diabetes, Parkinson’s or osteoarthritis. They are primitive cells that can develop into a range of mature cells and perhaps serve as replacements. But progress is slow. After a flurry of stem cell excitement two decades ago, almost all the research today is still in mice or petri dishes. The very few clinical trials that have begun are still in the earliest phase.
The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritisautismcerebral palsystrokemuscular dystrophy, A.L.S., cancer?
An orthopedic clinic, for example, says on its website, “Stem cells actually restore degenerated tissue while providing pain relief.” Another clinic seeks patients with neurological diseases, asserting, “The regenerative nature of the fatty adult stem cells that are extracted from the patient can help improve the degeneration and ease the symptoms associated with the disease.”
The rapid proliferation of stem cell clinics “looks like it is occurring on a nationwide industrial scale,” said Leigh Turner, a bioethicist at the University of Minnesota, who, with Paul S. Knoepfler, a stem cell researcher at the School of Medicine of the University of California, Davis, published the new paper tallying the clinics. “It’s operating brazenly, out in the open. It leaps out of these cultural assumptions about hopes and dreams of stem cell treatment, but there is no science behind it.”
The Food and Drug Administration allows clinics to inject patients with their own stem cells as long as the cells, or the tissue the cells are extracted from, meet specific criteria, including “minimal manipulation,” and are intended to perform their normal basic function.
But even if treatments the clinics advertise seem questionable, the F.D.A. cannot act based on a website. “They have to have actual cases of clinics administering the cells to patients,” said Ubaka Ogbogu, an assistant professor of law at the University of Alberta in Canada who has studied the clinics and their regulation. “These clinics are being run by very sophisticated people. They understand the laws very well and have been working around the laws.”
Some clinics advertise treatments that seem to flout the regulations, offering, for example, stem cells from amniotic fluid, which do not qualify under the F.D.A.’s rules because they are not from the patient’s body. Others advertise stem cells collected from a person’s blood or fat to treat a neurological disease like Parkinson’s disease or multiple sclerosis. Those cells do not qualify because they do not normally function in the brain to control movement. There is no registry of patients going to these clinics, so it is unclear how many have been treated.
Outraged, Dr. Knoepfler has confronted some of the clinics.
“I have spoken to the clinics and they say, ‘O.K., you have lectured me about F.D.A. regulations, but I have been doing this for years and never heard a peep from the F.D.A.’ They see it as a tacit green light,” Dr. Knoepfler said.
On their websites, the clinics promote anecdotes and videos of happy patients. One clinic that uses stem cells to treat neurological diseases has a video of a patient, Barbara, and her husband on its website. She says she has multiple sclerosis and reports marked improvements after stem cell treatments, like driving again for the first time in years. “I feel so blessed that I have gotten better from the procedure,” she says.
Professional medical societies and state licensing boards should crack down, says Insoo Hyun, an ethicist at Case Western Reserve University and past ethics chairman for the International Society for Stem Cell Research (ISSCR). After all, he said, the stem cell clinics employ doctors, and doctors have a duty to offer patients evidence-based medicine.
But academic scientists feel stymied.
Dr. George Q. Daley, a stem cell researcher at Harvard Medical School and a past president of the International Society for Stem Cell Research, explained, “At ISSCR, we have spoken fairly aggressively about the false claims, but we have no enforcement power.” The group has its own website, A Closer Look at Stem Cells, that tries to caution patients, but Dr. Daley acknowledges it is no match for the clinic websites.

A health-care model for the nation
By Joseph DeMattos Jr.

The year 1980 was a landmark for Maryland in many ways. The Orioles won 100 games for the second consecutive year under the leadership of manager Earl Weaver. And Maryland’s health-care policy leaders, seeking to improve hospital funding, finalized a landmark deal with Medicare that became today’s hospital waiver. 
Like the 1980 Orioles’ home run leader Eddie Murray, these policy leaders swung for the fences by guaranteeing the federal government that Maryland’s rate of growth for Medicare-paid care in hospitals would rise more slowly than the national average . For most of the 36 years since, Maryland kept that bargain
Maryland operates the nation’s only hospital rate-regulation system, with a Health Services Cost Review Commission that sets rates for hospitals. In the past decade, it became apparent to Maryland and national health-care leaders that the waiver had become obsolete, spurring health-policy leaders to update it. 
The updated waiver requires Maryland hospitals to achieve quality improvements, including reductions in 30-day hospital readmissions and hospital-acquired health conditions. It also limits all-payer per-capita hospital growth to a rate lower than the national average. And it mandates that Maryland generate $330 million in Medicare savings over five years. 
Maryland faces serious challenges — broad health-care disparities, chronic underfunding of the Medicaid program and uncertainty on the regulatory front. 
The data collected after year two of the waiver indicate that Maryland remains on the right track, especially in terms of care-coordination trends, which illustrate the value of care offered by providers outside of hospital settings in partnership with hospitals.
In 1980, the typical person who entered a nursing home was an elderly woman in good health who drove up to the center in a car with her family. At the home, she joined other elders, almost all women, in activities such as reading club, crochet and high tea — much like what you see in today’s assisted-living communities. 
Today, the typical person entering a skilled nursing rehabilitation center in Maryland arrives via ambulance, most often after an acute hospital stay. While the average age of individuals treated in a center is 78, nearly 20 percent of those individuals served in nursing homes are younger than 65. And, unlike in 1980, Maryland’s updated hospital waiver focuses on the total cost of care, including care received in skilled nursing and rehabilitation centers. 
Skilled nursing centers today are treating a sicker and more diverse patient population and have increased the services that they provide by offering IV treatment, ventilator care, dialysis, post-heart attack and post-stroke care and orthopedic, physical and occupational rehabilitative care. These services are provided at substantially lower cost than at hospitals. This is critical relative to the new waiver, as it gives hospitals an incentive to discharge patients to these centers when appropriate.
The data indicate that Medicare beneficiaries who are discharged from the hospital to nursing homes are much sicker than those who go directly home. On average, those discharged to skilled nursing have required almost nine days of hospital care.
Going forward, hospitals and skilled nursing rehabilitation centers in Maryland will partner more deeply to lower that costly hospital stay for these patients. This can be done in part by removing the outdated three-day hospital stay requirement for patients to qualify for skilled nursing benefits from Medicare. 
As Maryland’s leaders continue to update and improve the waiver, hospitals and skilled nursing rehabilitation centers likely will work together by bundling payments and partnering to deliver care, which also creates cost savings.
Gone are the days when health-care providers could be treated as downstream vendors. Going forward, the waiver will work only if providers are full and equal partners. Nursing homes must be allowed to apply their post-acute and transitional-care expertise, supported by stable rates and meaningful quality measures. 
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Maryland has an opportunity to revolutionize health care and build on the bold and strategic thinking of policy leaders that started in 1980. Together, we can ensure that Maryland is the health-care model for the nation. 
The writer is president and chief executive of the Health Facilities Association of Maryland.

How Valeant Cashed In Twice on Higher Drug Prices

Continue reading the main storyBut even if treatments the clinics advertise seem questionable, the F.D.A. cannot act based on a website. “They have to have actual cases of clinics administering the cells to patients,” said Ubaka Ogbogu, an assistant professor of law at the University of Alberta in Canada who has studied the clinics and their regulation. “These clinics are being run by very sophisticated people. They understand the laws very well and have been working around the laws.”

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