This entry is from Dr. McCanne's Quote of the Day, a daily health policy update on the single-payer health care reform movement. The QotD is archived on PNHP's website.
Non-publication of large randomized clinical trials: cross sectional analysis
By Christopher W Jones, Lara Handler, Karen E Crowell, Lukas G Keil, Mark A Weaver, Timothy F Platts-Mills
BMJ, October 29, 2013
Randomized clinical trials are a critical means of advancing medical knowledge. Clinical trials depend on the willingness of participants to expose themselves to the risks of randomization, blinding, and unproven interventions. The ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial. Because the risks involved in trial participation may be significant, and because individual trial participants often do not benefit directly from trial participation, substantial safeguards have been implemented to protect the interests of study participants both prior to and during the trial. These safeguards take multiple forms, including oversight by institutional review boards, the informed consent process, and data and safety monitoring boards. Until recently, the protection of the interests of study participants after trial completion has received significantly less emphasis. This began to change in 1997 with the signing of the Food and Drug Administration Modernization Act in the United States, which mandated that the US Department of Health and Human Services establish a registry of clinical trials, thereby providing permanent, public access to information on the conduct of both publicly and privately funded clinical trials.
In 2005 the International Committee of Medical Journal Editors (ICMJE) required that prospective trials involving human participants be registered prior to the beginning of study enrollment in order to be considered for publication in member journals. This requirement was later incorporated into the ICMJE’s “uniform requirements for manuscripts submitted to biomedical journals,” along with the updated CONSORT 2010 statement for the reporting of randomized controlled trials. The prospective registration of phase II-IV clinical trials subsequently became federal law in the United States in 2007 with the passage of the Food and Drug Administration Amendments Act. This legislation also expanded the scope of ClinicalTrials.gov to include a database of trial results. Results from all registered studies may be posted to ClinicalTrials.gov, including studies completed prior to enactment of the Food and Drug Administration Amendments Act. In addition, reporting results is now mandatory for many trials. Failure to comply with this mandate can result in substantial penalties, including civil fines of up to $10 000 (£6200; €7400) per day and withholding of funds from investigators sponsored by the National Institutes of Health.
The registration of clinical trials serves an important role in protecting the interests of study participants after trial completion. In addition to discouraging investigators from preferentially choosing to report statistically significant positive outcomes, trial registration can increase awareness of possible publication bias within the medical literature by allowing the public to compare the subset of trials with published results to the total number of trials that were registered and conducted. Publication bias can distort the apparent efficacy of interventions, which complicates the interpretation of the medical literature. The non-publication of trial data also violates an ethical obligation that investigators have towards study participants. When trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized. Systematic trial registration provides a tool that can help to assess both the magnitude and the causes of these problems.
PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.
Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.
From the Discussion
Trial investigators and sponsors have an ethical obligation to study participants to publish trial results. This principle is implicit in the US Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” which outlines the scope and responsibilities of institutional review boards for overseeing research using human participants. The Common Rule states that institutional review board approval requires demonstration that “risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.” Similarly, the Declaration of Helsinki, which was instrumental in developing the modern system of oversight by institutional review boards, also acknowledges the importance of disseminating research results, stating “Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.” By directing institutional review boards to assess the societal importance of resulting knowledge in addition to the possible risks and harms to individual research participants, the Common Rule provides justification for institutional review board oversight of results reporting, including trial registration and publication. Because the involvement of institutional review boards with clinical trial oversight begins prior to participant enrollment, these institutions are uniquely positioned to protect the rights of study participants throughout all stages of trial conduct, from study planning to reporting results. Given the persistent problem of unpublished trial results despite continued emphasis on trial registration from governmental agencies, funding organizations, and the editorial community, increased institutional review board attention toward this issue may be needed.
We observed that non-publication is common among large randomized clinical trials. Furthermore, the sponsors and investigators of these unpublished trials infrequently utilize the ClinicalTrials.gov results database. The lack of availability of results from these trials contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation. Additional safeguards are needed to ensure timely public dissemination of trial data.
Publication bias of drug and device studies has bordered on the criminal. Industry funded studies in particular were often withheld from publication if the results were not favorable for the future marketing of the product; that is, if the studies showed no benefit or, worse, if they showed that the products were harmful.
Recognizing the problem, in 2005 medical journal editors began to require that studies be registered before clinical trials began or the studies would not be published in peer reviewed journals. In 2007 the federal government began to mandate the reporting of studies with the threat of civil fines for failing to comply. Many of us recognized that this failure of the private sector required government intervention, and we were relieved to finally see it.
Alas, this study shows that non-compliance is still common, especially with industry funded studies. Not only does this corrupt the data bases on which our knowledge of new drugs and devices relies, it is also a failure of ethics by withholding results of human experimentation consented to by individuals who placed their health at stake to advance our understanding of the benefits and potential harms of these products. That ethical failure extends to future individuals who might be exposed to ineffective or harmful interventions merely because this adverse information was withheld from the medical community.
There is an analogy with single payer. Private sector enthusiasts insist on exposing us to the waste, inefficiencies, and sometimes harm inflicted on us by the private insurance industry and its marketplace applications. The administrators of a government single payer program do not experiment with patients in order to expand the market for health care. However, they do collect generic data, rather than hiding it, to help advance our understanding of beneficial health care interventions.
Whether it’s drug and device research or health care financing, we need more government involvement, not less.
This entry is from Dr. McCanne's Quote of the Day, a daily health policy update on the single-payer health care reform movement. The QotD is archived on PNHP's website.
Everybody In, Nobody Out: Memoirs of a Rebel Without a Pause
By Quentin Young, M.D.
From the Epilogue
From my adolescent years to the present, I’ve never wavered in my belief in humanity’s ability – and our collective responsibility – to bring about a more just and equitable social order. I’ve always believed in humanity’s potential to create a more caring society.
That viewpoint has infused my relations with family, friends, patients, and medical colleagues. It has been a lifelong, driving force to promote equality and the common good, and I believe it has served me well.
I suppose being a physician has made it easier for me to work toward this goal. Easier, that is, than if I had chosen a different occupation. I’ve spent a lifetime trying to help others – in my daily rounds, in my clinic, as a hospital administrator, at demonstrations, in my work with health advocacy groups – and it all adds up to a deeply rewarding career. Few people have had such good fortune.
But as you’ve no doubt noticed in the preceding pages, my views and actions have also propelled me into sharp conflict with institutions and persons who would perpetuate injustice. That was true yesterday; it remains true today. My work is unfinished.
This weekend in Boston at the annual meeting of Physicians for a National Health Program, we will be celebrating the 90th birthday of Quentin Young. This is no ordinary birthday for no ordinary man. He lives up to his name by remaining young and vibrant as he continues his lifelong quest for equality and the common good, while fighting the forces of injustice. His work is unfinished.
Quentin has been a personal inspiration to me as he was the person who guided me at the pivot point in my life when I shifted from the practice of medicine to my second calling as a passionate advocate of health care justice. He will continue to be my inspiration.
This entry is from Dr. McCanne's Quote of the Day, a daily health policy update on the single-payer health care reform movement. The QotD is archived on PNHP's website.
The President Wants You to Get Rich on Obamacare
By Adam Davidson
The New York Times Magazine, October 30, 2013
(Tom) Scully was scheduled to deliver the keynote address at an event hosted by the Potomac Research Group, a Beltway firm that advises large investors on government policy (tag line: “Washington to Wall Street”).
When Scully finally began his speech, he noted that the prevailing narrative among Republicans — assuming that many in the room were, like him, Republican — was incorrect. “(Obamacare) is not a government takeover of medicine,” he told the crowd. “It’s the privatization of health care.”
Scully then segued to his main point, one he has been making in similarly handsome dining rooms across the country: No matter what investors thought about Obamacare politically — and surely many there did not think much of it — the law was going to make some people very rich.
A couple of years ago, Scully identified his best bet. NaviHealth, the company he co-founded, is designed to streamline an enormous but often overlooked corner of the health care market that, many studies conclude, is the most financially wasteful: post-acute care, or the treatment of patients (mostly seniors) after hospitalization for surgery or serious illness.
Scully has a simple way of describing what NaviHealth — and much of the Affordable Care Act — brings to medicine. “It’s called capitalism,” he told me. “Which doesn’t exist in health care, really.”
In 2001, after George W. Bush appointed Scully the administrator of what would soon be known as the Centers for Medicare and Medicaid Services, he at last began to implement his ideas. Scully focused on designing and executing Medicare Part D, which opened one corner of government-provided health care — pharmaceuticals — to market forces. This created a new role for a previously relatively obscure business, the pharmacy benefit manager, or P.B.M., which streamlined prescription-drug services. Express Scripts, a once modest Midwestern company, used economies of scale to lead the effort in shifting seniors from expensive name-brand drugs into generics. According to Fortune, it is now the 24th-largest company in America.
By the time Medicare Part D went into effect in 2006, Scully, who was by then in the private sector, put his theory to the test. He invested in a smaller P.B.M., MemberHealth, which grew, in three years, from $6 million in revenue to $1.2 billion. “It was a hockey stick,” he recalls. “It took off like a rocket.” When the A.C.A. was near passage, Scully hoped to repeat the success. Once he and his partners at Welsh, Carson realized no one else had seen the potential in post-acute care, he thought he had another MemberHealth on his hands. “That’s what I expected with NaviHealth,” he told me. “I felt the same way: we would take off like a rocket.”
On the morning that Congress finalized the deal that would reopen the government and defeat — for a few weeks, at least — the latest Republican effort to derail Obamacare, I visited Scully in his New York office. Scully then began a set speech I had heard many times about how Republicans don’t understand the new health care law, that it’s actually more, not less, capitalistic than anything that came before.
Whether all this money flowing from Washington to Wall Street will benefit the rest of us is another question. Glenn Hubbard, the pre-eminent economist who helped devise George H. W. Bush’s health plan with Scully, told me that the cost of the A.C.A. will far outpace any possible efficiencies. Dean Baker, an economist at the progressive Center for Economic and Policy Research, told me that a government-run single-payer plan would be far more beneficial.
Former CMS administrator Thomas Scully has been a major player in injecting more capitalism into health care. This article describes his mindset, including the fact that he intends to get his share of the mega-wealth that health care privatization is creating.
Look at some of the trends:
* Medicare + Choice was established to allow private insurers to compete with Medicare with the goal of eventually transforming our public Medicare program into a market of private health plans.
* When the insurers couldn’t compete, Medicare + Choice was replaced with Medicare Advantage – a scheme designed to overpay private insurers by 14% in order to give them an “advantage” in the Medicare marketplace – with the intent of eventually displacing traditional Medicare.
* The Medicare Part D drug plan was designed to use private pharmacy benefit managers – diverting a massive amount of taxpayer funds to the capitalists, while prohibiting government negotiation of fair drug prices.
* The architects of the Affordable Care Act rejected a government single-payer solution and set up exchanges of private insurance plans that would siphon off more taxpayer dollars to pay for the private sector’s wasteful administrative excesses.
* Although the widely discussed “public option” would have had little impact since it would not have changed our basic, fragmented health financing infrastructure, nevertheless, even it was rejected as allowing too much of a government role in a health insurance market that the pro-market capitalists wanted to control completely.
* As a token tossed to the public option advocates, co-ops were authorized in the Affordable Care Act. These organizations – to be managed by representatives of the patients – were poisoned by a model that saddled them with massive intolerable debt service that would make it impossible to compete with the private insurers, not to mention that they are prohibited from marketing their product to the public. Competition is fine when the private sector is given unfair advantages over government programs, but, in the minds of these capitalists, it is unfair to allow a government or even quasi-government program to compete against the private sector. The government cheats by unfairly providing greater efficiency and value. Medicare’s administrative costs are 1.4% whereas the Affordable Care Act grants private insurers 15% to 20% administrative costs including profits.
* The Affordable Care Act also gave a great boost to consumer-directed health care – a concept of expanding the role of marketplace decisions in the purchasing of health care. By establishing a low actuarial value in the benchmark plans in the insurance exchanges – the patient pays a greater percentage of health care costs out of pocket primarily through high deductibles – much needed regulatory oversight is being replaced with the flawed theory that price decisions in the marketplace will bring health care costs under control.
* Under the false theory that government austerity measures are required to stimulate a thriving market by limiting taxation, Medicare and Social Security remain under threat by those who would privatize these programs through measures such as Medicare vouchers.
We need to understand what Scully is trying to say: The law is going to make some people very rich. Is that what we what from the most expensive and most dysfunctional health care system of all wealthy nations? We have been warned.
Dean Baker got only one line in this very long article: a government-run single-payer plan would be far more beneficial. That should be our take-home message.
Here’s how GOP Obamacare hypocrisy backfires
By Michael Lind
Salon, October 28, 2013
The smartest thing yet written about the botched rollout of the Affordable Care Act’s federal exchange program is a post by Mike Konczal of the Roosevelt Institute at his “Rortybomb” blog at Next New Deal. Konczal makes two points, each of which deserves careful pondering.
The first point is that to some degree the problems with the website have been caused by the overly complicated design of Obamacare itself.
Konczal’s second point is even more important — the worst features of Obamacare are the very features that conservatives want to impose on all federal social policy: means-testing, a major role for the states, and subsidies to private providers instead of direct public provision of health or retirement benefits.
This point is worth dwelling on. Conservatives want all social insurance to look like Obamacare. The radical right would like to replace Social Security with an Obamacare-like system, in which mandates or incentives pressure Americans to steer money into tax-favored savings accounts like 401(k)s and to purchase annuities at retirement, with means-tested subsidies to help the poor make their private purchases. And most conservative and libertarian plans for healthcare for the elderly involve replacing Medicare with a totally new system designed along the lines of Obamacare, with similar mandates or incentives to compel the elderly to buy private health insurance from for-profit corporations.
Will the flaws of Obamacare really hurt the right and help center-left supporters of universal social insurance? I doubt it.
To begin with, this implies a willingness of the right to acknowledge that Obamacare, in its design, is essentially a conservative program, not a traditional liberal one. But we have just been through a presidential campaign in which Mitt Romney, who as governor of Massachusetts presided over the creation of the most important model for Obamacare, rejected any comparison of Romneycare with Obamacare
Nor are progressives likely to press the point in present or future debates. Unlike conservatives, who are right-wingers first and Republicans second, all too many progressives put loyalty to the Democratic Party — most of whose politicians, including Obama, are not economic progressives — above fidelity to a consistent progressive economic philosophy. These partisan Democratic spinmeisters are now treating Obamacare, not as an essentially conservative program that is better than nothing, but as something it is not — namely, a great victory of progressive public policy on the scale of Social Security and Medicare.
In doing so, progressive defenders of Obamacare may inadvertently be digging the graves of Social Security and Medicare.
If Obamacare — built on means-testing, privatizing and decentralization to the states — is treated by progressives as the greatest liberal public policy success in the last half-century, then how will progressives be able to argue against proposals by conservative Republicans and center-right neoliberal Democrats to means-test, privatize and decentralize Social Security and Medicare in the years ahead?
I’m sure a number of token “centrist” Democrats will be found, in due time, to support the replacement of Medicare by Lifelong Obamacare. And with neoliberal Democratic supporters of the proposal as cover, the overclass centrists of the corporate media will begin pushing for Lifelong Obamacare as the sober, responsible, “adult” policy in one unsigned editorial after another.
Once Medicare has been abolished in favor of Lifelong Obamacare, perhaps by a future neoliberal Democratic president like Clinton and Obama, Social Security won’t last very long.
The conservative Republicans and centrist Democrats will argue that the success of Obamacare, in both its initial version and the new and improved Lifelong Obamacare version, proves that a fee-based, means-tested, privatized and state-based system is superior to the universal, federal, tax-based Social Security program enacted nearly a century ago in the Dark Age known as the New Deal.
The genuine progressives will respond with a defense of Social Security. Whereupon the faux-progressives, the neoliberal heirs of Carter, Clinton and Obama, will reject the option of preserving Social Security — why, that’s crazy left-wing radical talk! — but insist that the subsidies for the poorest of the elderly be slightly increased, as the price for their adoption of the conservative plan to destroy Social Security. Throughout the process, the right-wing Republicans and neoliberal Democrats will ask, “How can progressives object to means-testing, privatization and 50 state programs, when those are the very features of the Obamacare system that our friends on the left celebrate as a great achievement?”
Think about it, progressives. The real “suicide caucus” may consist of those on the center-left who, by passionately defending the Affordable Care Act rather than holding their noses, are unwittingly reinforcing the legitimacy of the right’s long-term strategy of repealing the greatest achievements of American liberalism.
(Michael Lind is co-founder of New America Foundation.)
The Next Social Contract
By Michael Lind
New America Foundation
The Affordable Care Act, backed by President Barack Obama, focused on the problem of coverage rather than costs. The ACA rejected the New Deal/ Great Society tradition of universal, taxpayer-based social insurance for the conservative alternative of tax expenditures and individual mandates to purchase private health insurance.
While some elements of the law are laudable, as a whole the ACA combines all of the faults of the bad approaches to public policy, while rejecting the sound approach of universal federal social insurance. Means-tested subsidies, tax expenditures, and elaborate federal-state hybrid systems (in this case, health care exchanges) are all united in an overly-complicated system. For working-age, non-poor Americans, the Affordable Care Act (ACA) envisions a transition from system of tax expenditures based on employers to another indirect system based on tax subsidies to individuals purchasing insurance in state-created exchanges.
In the long run, the health insurance system should be integrated into a single, life-long, comprehensive social insurance program. As a step in that direction, Medicaid and SCHIP, two inefficient and unfair federal-state hybrid programs, should be completely federalized and merged with Medicare.
The U.S. health insurance system is likely to move either toward efficient social insurance or toward inefficient and costly voucherization of the social insurance elements like Medicare and Medicaid, combined with rationing of health care of a kind unknown in other advanced industrial democracies. For reasons of solvency and fairness alike, health insurance needs to be absorbed into an expanded, comprehensive American social insurance system.
Report: “The Next Social Contract” (44 pages): http://nsc.newamerica.net/sites/newamerica.net/files/policydocs/Lind_Mic…
Mike Konczal’s article covered in yesterday’s Quote of the Day message has received considerable attention in the blogs, since his concept was a real eye opener. While most are distracted by the temporary kludge of the opening of the federal Obamacare exchange website, the real lesson is that the complexity of coordinating all of the entities that are involved in enrolling individuals into the exchange plans confirms the complexity of Obamacare itself. The computers will be fixed, but Obamacare can never be.
Michael Lind of the New America Foundation elaborates on Konczal’s observation that the neoliberal Democrats have adopted the conservatives’ model of reform – “a fee-based, means-tested, privatized and state-based system.” Even though neoliberals and conservatives theoretically are bitter enemies (witness the insults hurled over the shutdown of the government), and battle publicly over Obamacare, they are silent partners in delivering to the nation the Heritage/Romney/Clinton/Obama model of a largely privatized health care financing system.
The New Deal/Great Society approach to our social insurance programs – Medicare and Social Security – was to make them federally administered and federally financed, an approach then supported by centrists and liberals. Now we have a conservative program – Obamacare (that really isn’t social insurance, especially when considering how many are left out) – that is now supported by centrists and silently by conservatives (e.g., Ryan’s Republican voucher plan for Medicare).
Publicly, only the liberals are standing up for expanding an improved version of Medicare to cover everyone. Many of the centrists also support it but are toeing the neoliberal line of Democratic Party loyalty by remaining silent (not to mention the fear of offending their health industry campaign contributors). Most conservatives recognize the superiority of the single payer model in achieving the goals of universality, equity, and affordability, but many are also libertarians and are opposed to those goals simply because of their ideology.
We need to abandon the process of trying to meet on common ground through the Democratic and Republican parties. Virtually all liberals, most moderates, and some conservatives agree that everyone should have health care and that it should be financed equitably through an administratively efficient program. When we vote we should ignore the candidates’ political parties, but instead vote based on their advocacy for health care justice (and other forms of social justice). For those who do not think that is feasible, all we need is more visibility (a cryptic comment if there ever was one, but use your imagination).
UNISON responds to appointment of Simon Stevens as NHS chief executive
UNISON, October 24, 2013
Responding to the announcement that the president of Global Health and group executive vice-president at UnitedHealth, Simon Stevens, will take on the role of chief executive of NHS England in April next year, UNISON Head of Health Christina McAnea said:
“The NHS is facing its first serious crisis for the best part of the decade, and it is critical that Simon Stevens respects and shares the values of our NHS – universal healthcare that is free at the point of need.
“It is surprising that no one within the NHS has been found to take on this position. We sincerely hope this is not a sign that the government wants to import America-type values into the NHS and look at ways of developing healthcare through an insurance model. If this is the intention there will be massive opposition.
“Mr Stevens will have his work cut out for him right from the start. Far from being protected from government cuts, the NHS is being starved of the funds it needs. Thousands of jobs are under threat and accident and emergency departments are creaking under the pressure of cuts, privatisation and upheaval.”
(UNISON is a UK trade union of public employees)
Simon Stevens, new head of NHS England, is in for a rude awakening
Under Labour, Stevens began the culture of competition in health. He will now find out just how perverse this has become
By Polly Toynbee
The Guardian, October 24, 2013
As he sowed, so shall he reap. Simon Stevens will get his just deserts as he takes up the reins of NHS England, only to find this horse has no bridle or bit, galloping out of anyone’s control. That was, of course, precisely the explosive “creative destruction” Andrew Lansley intended. Stevens returns from the biggest US health company to an NHS whose current path he designed as Tony Blair’s adviser. Now he must piece together some coherence from the fragments of what Sarah Wollaston, MP and GP, called “a grenade” tossed into the NHS.
As Lansley outlined his scheme in 2010, Stevens wrote a paean of praise in the Financial Times. It reads as a touchingly optimistic vision, where choice and competition in a perfect market deliver everything a patient or GP could desire. When he sees what he’s inherited, he may get a rude awakening. But he shares the blame, claiming authorship: “What makes the coalition’s proposals so radical is not that they tear up (our) earlier plan,” but “move decisively towards fulfilling it – in a way that Mr Blair was blocked from doing by internal opposition”.
He lists the plan’s glories: in “the new model NHS, patients are rightly being promised that ‘no decision will be made about me, without me’”. No sign yet of that. He praises “the severing of day-to-day political control of the NHS”, but now he’ll find his own control severed. How will he marry his vouchers for pregnant women with wildly unpopular maternity closures? His hope that “patient power will become real, GP commissioners will fire on all cylinders and hospitals will be liberated to innovate” is a world away from today’s NHS.
But his greatest regret may be his praise for “the decision to extend competition law across the health sector and treat the NHS as a regulated utility, with an economic regulator – Monitor”. Faith in competition fills his writings – but reality is biting back. Monitor, engine of NHS competition, has only just understood its destructive force: its chief executive, David Bennett, recently recoiled, saying Monitor would be “mad” to enforce the Lansley competition rules leaving commissioners to “spend all their time running competitive processes because they’re terrified they’re going to get in trouble if they don’t”. Too late now.
So far, 63% of contracts have been put out to tender by clinical commissioning groups (CCGs), now run by just a few GPs. The 211 CCGs are widely regarded as no match for the private sector in writing complex contracts. Section 75 of the Health and Social Care Act forces them to put all but a few services out or risk any putative bidder challenging them in court. Bringing competition law into the NHS means no one can control these unleashed forces.
Watch Stevens demand more changes to the law if he’s to control the unfolding chaos. Half of NHS trusts have announced a deficit for this year – that’s unprecedented – yet by 2017 the NHS must “save” £30bn. The Care Quality Commission says one in four hospitals are a safety risk, but their inspections aren’t allowed to count numbers of staff: the NHS has haemorrhaged 6,000 nurses since 2010. Many CCGs that control NHS funds are chaotic, with services falling between gaps, no one paying for them. Privatisation rushes on, at least £11bn so far, but private providers escape the NHS duty of openness or freedom for whistleblowers. Waiting times are rising, ambulance and A&E times growing, as the social care crisis blocks NHS beds with winter approaching.
Stevens will find many perversities in the competition culturre. He said top-down control was a disaster – but he may find fragmentation and lack of strategic control far worse. Can he make his perfect market work – or admit he might have been wrong?
The National Health Service in England currently exemplifies the greatest problem with publicly-administered and publicly-financed national health programs: They become subject to privatization efforts whenever conservatives gain control of the government. Selecting UnitedHealth’s Simon Stevens as chief executive of NHS England surely advances Conservative Prime Minister David Cameron’s privatization scheme.
When do you suppose UnitedHealth will put in a bid to purchase the NHS? It would be great for Cameron’s budget, though the people would lose out.
Health Care Law Fails to Lower Prices for Rural Areas
By Reed Abelson, Katie Thomas and Jo Craven McGinty
The New York Times, October 23, 2013
As technical failures bedevil the rollout of President Obama’s health care law, evidence is emerging that one of the program’s loftiest goals — to encourage competition among insurers in an effort to keep costs low — is falling short for many rural Americans.
While competition is intense in many populous regions, rural areas and small towns have far fewer carriers offering plans in the law’s online exchanges. Those places, many of them poor, are being asked to choose from some of the highest-priced plans in the 34 states where the federal government is running the health insurance marketplaces, a review by The New York Times has found.
Of the roughly 2,500 counties served by the federal exchanges, more than half, or 58 percent, have plans offered by just one or two insurance carriers, according to an analysis by The Times of county-level data provided by the Department of Health and Human Services. In about 530 counties, only a single insurer is participating.
The Obama administration, while not disputing the findings, responded to the analysis in a statement that the marketplaces “allow insurers to compete for customers based on price and quality.”
Observers cautioned against drawing too many conclusions from the current landscape, noting that several major insurers were waiting to see what happens next.
Polis fights sky-high rates as ski town signups stall
By Katie Kerwin McCrimmon
Solutions, October 23, 2013
Health insurance rates are so high in Colorado’s mountain resort areas that U.S. Rep. Jared Polis plans to seek waivers from the federal government so people who skip buying insurance in 2014 won’t face financial penalties.
Health coverage guides working to enroll Summit County residents in new health plans through Colorado’s health exchange have been deeply disappointed. They have not enrolled a single new client since Colorado’s health exchange launched on Oct. 1.
Another flaw in Obamacare is the failure in rural areas to make premiums affordable through health plan competition, primarily because the markets are too small to attract enough insurers to promote competition.
An example is found in the Colorado mountain resort areas such as Summit County where not one person has been enrolled through the exchange.
How many times do we have to say it? The Affordable Care Act was the wrong model for reform. It leaves in place our profoundly expensive, administratively inefficient, fragmented, dysfunctional health care financing system. Compared to what needed to be done, the improvements were only marginal, and some of the problems actually increased, such as underinsurance – plans that provide less health security and less financial security than many of us had before.
Besides, even in areas with greater plan competition, health care costs are still out of control. A publicly-administered single payer program is far more effective in getting health spending right than is health insurer competition.
The Restive Single Payer Tribe
By Ed Kilgore
Washington Monthly, Political Animal, October 21, 2013
But if I were in the White House, I’d keep an eye on one issue they might not have thought much about in quite some time: the revival of progressive hostility to Obamacare on grounds that the law reflected a “sell-out” of the obvious single-payer solution to the problems of the health care system.
I’m not going to relitigate the whole single-payer-versus-managed-competition debate that’s been going on for decades, or even the argument that a managed competition model requires a “public option” to function properly. But whatever else it is, a single-payer system is a whole lot simpler and more predictable than anything that not only accepts but insists upon a publicly regulated and subsidized private health insurance marketplace.
Single-payer fans (or those strongly favoring a public option in a hybrid system) are never going to have much in common with conservatives who don’t believe in universal access to affordable health care and want to disable or repeal the public programs we already have. But if the one thing they do have in common — disdain for the messy hydraulics of any hybrid system — becomes the center of attention and stays there, watch out!
Ed Kilgore is a contributing writer to the Washington Monthly. He is managing editor for The Democratic Strategist and a senior fellow at the Progressive Policy Institute.
It is fair to say that Ed Kilgore represents the views of neoliberals who have taken control of the Democratic Party and moved it to the right: that is, he represents centrist views. What is striking about his message is that the intensive political attacks on Obamacare by the conservatives are assisting single payer advocates who are busy exposing its profound policy deficiencies. With their noise, and our reasoned policy prescriptions, middle America may be ready to move to single payer much sooner than expected.
Predicting ACO Formation: Two Studies With More In Common Than It Might Seem
By Valerie Lewis, Carrie Colla, and Elliott Fisher
Health Affairs Blog, October 22, 2013
At a time when policy makers, providers and payers are all trying to make high stakes decisions about how respond to the proliferation of Accountable Care Organizations (ACOs), divergent research findings might feel as welcome as rain on the fourth of July.
Two recently published studies, one by our group at Dartmouth and one by David Auerbach and coauthors in Health Affairs, both examined predictors of ACO formation. On the surface, they appear to have some inconsistent findings. Their core conclusions, however, are similar, and differences in the results are readily explained. Most importantly, policy implications are well aligned: there is much we can do to help the transition to accountable care succeed.
A common set of policy implications
The findings in both studies also point to challenges that deserve further attention by policy makers. How can providers without experience in risk-based contracts or who are in smaller, more fragmented practices get the additional support they may need to become an ACO? Models like the Medicare Advance Payment model are one move to support these types of providers, but our results here and elsewhere suggest that policymakers should be further developing programs to support the financing of these systems, along with the development of analytic and care coordination capabilities that are likely necessary for ACO success.
Another important question
How can spending and quality benchmarks be refined to encourage broader participation? Some (including us) have suggested that paying for improvement rather than absolute performance on quality may encourage underperforming systems to join the ACO model. Careful thinking is necessary from health economists and health care finance experts on how to set cost targets that do not penalize providers already on the low end of the cost spectrum.
The imperative of continued learning
Perhaps the most important conclusion, however, is to acknowledge the many uncertainties that remain. The transition to performance-based payment systems has barely begun – and better information on what is working and what isn’t would make successful reform more likely.
If you are holding your breath to see if accountable care organizations (ACOs) are the answer to our quality and cost issues, I have some life-saving advice for you. Don’t wait, but breathe immediately!
Elliott Fisher from the Dartmouth Institute has been credited with coining the term, accountable care organization. Look at what he and his colleagues have to say: The most important conclusion is that many uncertainties remain.
One of the more important reasons for the uncertainties is that there remains a conflict between those who support better integration of health care (a noble goal) and those who support a business model that smacks of MBA-driven managed care (an ignoble goal).
There are no uncertainties with the single payer model. We should proceed immediately to the enactment of an improved Medicare for all, and then we can afford to take years to study variations of the ACO model to see if we can improve health care delivery.
Implementing Health Reform: The State Of The Exchanges, Income Verification, And More
By Timothy Jost
Health Affairs Blog, October 16, 2013
On October 11, 2013, HHS published a notice of information it was intending to collect to establish individual mandate exemptions.
There is nothing new in this notice, but the scope and number of exemptions from the ACA’s individual responsibility requirement are truly impressive. In addition to the religious conscience, health care sharing ministry, incarceration, Native American tribe membership, and lack of affordable coverage exemptions, there is an extensive list of hardship exemptions, including:
* Eviction in the previous 6 months or the threat of eviction or foreclosure;
* A utility shut-off notice;
* Recent death of a close family member;
* A fire, flood, or other natural or human-caused disaster that caused substantial property damage;
* A bankruptcy filing in the last 6 months;
* Medical expenses in the past 24 months that could not be paid;
* Unexpected increases in necessary expenses due to caring for an ill, disabled, or aging family member;
* The presence in the household of a child claimed as a tax dependent who was denied coverage in Medicaid and CHIP where another person is required by court order to give medical support to the child. In this case, the penalty need not be paid for the child;
* A favorable eligibility appeals decision that makes an individual eligible for enrollment in a qualified health plan (QHP) through the Exchange, lower the costs on monthly premiums, or provides cost-sharing reductions, which removes the penalty for the time the individual was not enrolled in a QHP through the Exchange; or
* Residence in a state that fails to expand Medicaid if the individual would have been eligible for Medicaid.
HHS estimates that 24 million Americans will be eligible for individual responsibility exemptions and that as many as 12 million will apply for exemptions through the exchange. In most instances, documentary evidence will need to be supplied to verify the exemption. Unless the federal exchange website is vastly improved in the not too distant future, this could create major problems for the implementation of the individual responsibility requirement.
CMS.gov – Supporting Statement for the Information Collection Requirements Contained in the Exemptions Eligibility Information Collection Request (25 pages): http://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS–10466.html
The Affordable Care Act includes multiple categories of exemptions from the shared responsibility payment – the penalty for remaining uninsured. This new CMS release defines the category of hardships which would allow you to remain uninsured without having to pay a penalty. When you check the list, it seems that most of these hardships would indicate a greater need for having health care coverage. But instead of seeking ways to fill these gaps, ACA simply cuts these people loose with no coverage at all.
The largest category of those who are exempt from the requirement to be insured are those who simply cannot afford to pay for their share of health insurance premiums. That includes families whose incomes are so low that they are not required to file income tax returns, and individuals who would have to pay more than 8% of their incomes for premiums beyond employer contributions or tax credits for the exchange plans. It includes individuals who would have been eligible for Medicaid but are excluded simply because their states elected not to participate in the Medicaid expansion.
HHS estimates that 24 million Americans will be eligible for exemptions from the shared responsibility payments. That is, 24 million individuals will have the right to remain uninsured without having to pay a penalty. That is quite a stipulation for an Act that was supposed to bring health care to everyone. 24 million!
Clearly our politicians selected the wrong model for reform. We do not have to put up with this. If enough of us protest vehemently, we should be able to get our politicians to replace this highly dysfunctional system with a single payer national health program – an improved Medicare that covers everyone – absolutely everyone.
The Coverage Gap: Uninsured Poor Adults in States that Do Not Expand Medicaid
The Kaiser Commission on Medicaid and the Uninsured, October 2013
The expansion of Medicaid, effective in January 2014, fills in historical gaps in Medicaid eligibility for low-income adults and has the potential to extend health coverage to millions of currently uninsured individuals. This expansion essentially sets a national Medicaid income eligibility level of 138% of poverty (about $27,000 for a family of three) for adults. The expansion was intended to be national and to be the vehicle for covering low-income individuals, with premium tax credits for Marketplace coverage serving as the vehicle for covering people with higher incomes. However, the June 2012 Supreme Court ruling made the expansion of Medicaid optional for states, and as of September 2013, 26 states did not plan to implement the expansion.
In states that do not expand Medicaid, over five million poor uninsured adults (5.2 million people) have incomes above Medicaid eligibility levels but below poverty and may fall into a “coverage gap” of earning too much to qualify for Medicaid but not enough to qualify for Marketplace premium tax credits. Most of these people have very limited coverage options and are likely to remain uninsured.
The ACA envisioned people below 138% of poverty receiving Medicaid and thus does not provide premium tax credits for the lowest income. As a result, individuals below poverty are not eligible for Marketplace tax credits, even if Medicaid coverage is not available to them. Individuals with incomes above 100% of poverty in states that do not expand may be eligible to purchase subsidized coverage through the Marketplaces; however, only about a third of uninsured adults (3.2 million people) who could have been eligible for Medicaid if their state expanded fall into this income range. Thus, there will be a large gap in coverage for adults in states that do not expand Medicaid.
According to this report, “Nationally, over five million poor uninsured adults will fall into the ‘coverage gap’ that results from state decisions not to expand Medicaid, meaning their income is above current Medicaid eligibility but below the lower limit for Marketplace premium tax credits.” That is, they are not eligible for Medicaid, and at an income below 138% of the federal poverty level, they are not eligible for subsidies and therefore cannot possibly afford to purchase private plans. They will remain uninsured, even though they have the least ability to pay out-of-pocket for health care.
These individuals falling into the coverage gap represent about one-sixth of the total number of individuals who will remain uninsured (31 million). Supposedly the Affordable Care Act was designed to make health care affordable for everyone, with an emphasis on Medicaid or private plan subsidies for those who could least afford to pay for coverage. By this standard, ACA can be considered a dud.
Let’s do it right. Let’s enact a single payer national health program that provides health care for everyone while separating the funding by moving it to the tax system. That would eliminate any connection between receiving health care and having to pay for it. Needing health care is bad enough without being assessed charges (in essence financial penalties) for obtaining that care.
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