By Uwe E. Reinhardt
Health Affairs Blog, June 1, 2016

Corporate executives, the management consultants who advise them, and the financial industry executives who help corporations finance their capital investments tend to believe that whenever their joint work enhances the wealth of a firm’s shareholders, they ipso facto enhance also the nation’s wealth. It is a soothing narrative, one routinely trotted out to college students in their textbooks of economics, which often slouch vaguely toward propaganda.

Very often this narrative is, of course, valid. It is especially so for venture capitalism, which acts as the midwife, so to speak, of newly-born companies creating valuable products hitherto unknown. It is valid also when established companies introduce new products or even when they merely expand existing product lines. Hereafter in this post, this version of capitalism will be labeled “value creation.”

But, as the pharmaceutical industry has been busily teaching us in recent times, alongside this value-creating facet, modern capitalism can also play a more dubious role by merely redistributing wealth from some members of society (for example, sick people) to the shareholders of particular enterprises, without making any net contribution to overall social value. Hereafter we refer to this process as “value shifting,” meaning that value is taken away from some members of society and channeled to the owners of capital.

It is widely thought that the proper fraction of total social value to be garnered by health care product manufacturers as sales revenue is one that just covers research and development (R&D) and production costs, with a profit margin designed to encourage further innovation — hence the demand that drug manufacturers make their costs transparent to the public. Health care product manufacturers, on the other hand, argue that the proper base for their pricing policies is not the cost of developing and producing their products, but the total social value they create for society. This pricing policy is called “value pricing.” At its extreme, it can extract enormous prices from seriously stricken patients or their insurers, because better health and longer life are so precious.

There is growing evidence that, save perhaps for some economists, American society is not comfortable with the idea of value pricing in health care, as can be inferred from the uproar over the pricing policy adopted by Turing Pharmaceuticals, which raised the price of one long-established product by 5,000 percent, and of Valeant Pharmaceuticals International. Valeant’s business model has been to acquire already existing pharmaceutical companies with long-established products, substantially increase the prices of these products and further enhance short-run cash flow to shareholders, reducing outlays on R&D by the acquired firms. These strategies are purely value shifting. In fact, it can be argued that by reducing R&D spending, Valeant destroyed social value.

Although Turing Pharmaceuticals’ and Valeant Pharmaceuticals’ business models are extreme versions of value shifting, the entire drug industry has for some time now leaned more and more toward that model by repeated price increases for long-existing products. Substantial price hikes have been observed even for off-patent generic products.

Spokespeople for the industry argue that the cash from these price increases flows directly to higher spending on R&D. Some of it probably does. But these firms spend considerably more on SG&A, which stands for “sales [marketing] and general and administrative expenses.” Spending on R&D by these companies tend to be well below 20 percent of revenue, while spending on SG&A is well above 20 percent. From the endless series of advertisements for prescription drugs on cable and network news and entertainment, patients (sick people) can infer that with the prices they pay for drugs, directly out of pocket or through health-insurance premiums, they now have become the main source of financing for the television industry — a truly bizarre circumstance.

Another part of the added cash flow generated by price hikes on existing pharmaceutical products often flows to shareholders through buy-backs of these firms’ stocks in the open market, to boost the earnings per share of the remaining stock outstanding. As Obi Ezekoye, Tim Koller, and Ankit Mittal of McKinsey and Co. argued in a recent article, these stock buy-backs usually do not create value even for the remaining shareholders, let alone add social value.

In short, it is far from clear to what end the industry’s repeated price increases under value shifting are used by the industry. There is no reason to believe that they will all, or even predominantly, flow into R&D.

Consolidation in both the R&D-based and the generics industry through mergers appear to have contributed to value shifting. When large pharmaceutical firms acquire smaller entrepreneurial companies, the objective usually is to expand the R&D pipeline of the large companies whose own R&D shops may have failed to produce enough new breakthroughs. But when large pharmaceutical companies or other health care companies merge, the objective is likely to be mainly to reduce price competition.

There is ample empirical research in health economics showing that consolidation on the supply side of the health care sector has served to drive up prices. It is another way of saying that it supports value shifting, rather than value creation.

My gratuitous advice to the drug industry, and to the health care industry in general, is to be very mindful of the distinction between value creation and value shifting in their pricing policies, lest they eventually invoke the wrath of the losers in that game, with dire consequences.

A healthy addition to corporate board meetings at these companies, for example, might be a presentation on the distribution of family income in the United States, whose median now is around $52,000 (meaning 50 percent of American families have a lower family income). Similarly, the boards should know more about the health insurance status of the American people, including the ever-increasing deductibles and coinsurance families are made to bear. These data might give boards some feel for how much money can reasonably and humanely be extracted from their fellow Americans, especially those in the bottom half of the income distribution, with whom the boards and business executives have lost touch.

http://healthaffairs.org/blog/2016/06/01/value-creation-and-value-shifting-in-health-care/

***

Comment:

By Don McCanne, M.D.

Uwe Reinhardt once again helps us to understand another aspect of the inequitable economics in our health care system by explaining the difference between value creation and value shifting.

Bringing us new beneficial health care services and products creates value, whereas extracting more revenues from the ill without providing any further health benefit shifts value, creating more wealth for the owners of capital (rent-seekers). Value shifting is pervasive throughout our health care system and has been detrimental to the health and finances of middle- and low-income individuals and families.

Reinhardt concludes, “My gratuitous advice to the drug industry, and to the health care industry in general, is to be very mindful of the distinction between value creation and value shifting in their pricing policies, lest they eventually invoke the wrath of the losers in that game, with dire consequences.”

Dire consequences for the health care rent-seekers, anyone? It’s about time.

By Uwe E. Reinhardt
Health Affairs Blog, June 1, 2016

Corporate executives, the management consultants who advise them, and the financial industry executives who help corporations finance their capital investments tend to believe that whenever their joint work enhances the wealth of a firm’s shareholders, they ipso facto enhance also the nation’s wealth. It is a soothing narrative, one routinely trotted out to college students in their textbooks of economics, which often slouch vaguely toward propaganda.

Very often this narrative is, of course, valid. It is especially so for venture capitalism, which acts as the midwife, so to speak, of newly-born companies creating valuable products hitherto unknown. It is valid also when established companies introduce new products or even when they merely expand existing product lines. Hereafter in this post, this version of capitalism will be labeled “value creation.”

But, as the pharmaceutical industry has been busily teaching us in recent times, alongside this value-creating facet, modern capitalism can also play a more dubious role by merely redistributing wealth from some members of society (for example, sick people) to the shareholders of particular enterprises, without making any net contribution to overall social value. Hereafter we refer to this process as “value shifting,” meaning that value is taken away from some members of society and channeled to the owners of capital.

It is widely thought that the proper fraction of total social value to be garnered by health care product manufacturers as sales revenue is one that just covers research and development (R&D) and production costs, with a profit margin designed to encourage further innovation — hence the demand that drug manufacturers make their costs transparent to the public. Health care product manufacturers, on the other hand, argue that the proper base for their pricing policies is not the cost of developing and producing their products, but the total social value they create for society. This pricing policy is called “value pricing.” At its extreme, it can extract enormous prices from seriously stricken patients or their insurers, because better health and longer life are so precious.

There is growing evidence that, save perhaps for some economists, American society is not comfortable with the idea of value pricing in health care, as can be inferred from the uproar over the pricing policy adopted by Turing Pharmaceuticals, which raised the price of one long-established product by 5,000 percent, and of Valeant Pharmaceuticals International. Valeant’s business model has been to acquire already existing pharmaceutical companies with long-established products, substantially increase the prices of these products and further enhance short-run cash flow to shareholders, reducing outlays on R&D by the acquired firms. These strategies are purely value shifting. In fact, it can be argued that by reducing R&D spending, Valeant destroyed social value.

Although Turing Pharmaceuticals’ and Valeant Pharmaceuticals’ business models are extreme versions of value shifting, the entire drug industry has for some time now leaned more and more toward that model by repeated price increases for long-existing products. Substantial price hikes have been observed even for off-patent generic products.

Spokespeople for the industry argue that the cash from these price increases flows directly to higher spending on R&D. Some of it probably does. But these firms spend considerably more on SG&A, which stands for “sales [marketing] and general and administrative expenses.” Spending on R&D by these companies tend to be well below 20 percent of revenue, while spending on SG&A is well above 20 percent. From the endless series of advertisements for prescription drugs on cable and network news and entertainment, patients (sick people) can infer that with the prices they pay for drugs, directly out of pocket or through health-insurance premiums, they now have become the main source of financing for the television industry — a truly bizarre circumstance.

Another part of the added cash flow generated by price hikes on existing pharmaceutical products often flows to shareholders through buy-backs of these firms’ stocks in the open market, to boost the earnings per share of the remaining stock outstanding. As Obi Ezekoye, Tim Koller, and Ankit Mittal of McKinsey and Co. argued in a recent article, these stock buy-backs usually do not create value even for the remaining shareholders, let alone add social value.

In short, it is far from clear to what end the industry’s repeated price increases under value shifting are used by the industry. There is no reason to believe that they will all, or even predominantly, flow into R&D.

Consolidation in both the R&D-based and the generics industry through mergers appear to have contributed to value shifting. When large pharmaceutical firms acquire smaller entrepreneurial companies, the objective usually is to expand the R&D pipeline of the large companies whose own R&D shops may have failed to produce enough new breakthroughs. But when large pharmaceutical companies or other health care companies merge, the objective is likely to be mainly to reduce price competition.

There is ample empirical research in health economics showing that consolidation on the supply side of the health care sector has served to drive up prices. It is another way of saying that it supports value shifting, rather than value creation.

My gratuitous advice to the drug industry, and to the health care industry in general, is to be very mindful of the distinction between value creation and value shifting in their pricing policies, lest they eventually invoke the wrath of the losers in that game, with dire consequences.

A healthy addition to corporate board meetings at these companies, for example, might be a presentation on the distribution of family income in the United States, whose median now is around $52,000 (meaning 50 percent of American families have a lower family income). Similarly, the boards should know more about the health insurance status of the American people, including the ever-increasing deductibles and coinsurance families are made to bear. These data might give boards some feel for how much money can reasonably and humanely be extracted from their fellow Americans, especially those in the bottom half of the income distribution, with whom the boards and business executives have lost touch.

http://healthaffairs.org/blog/2016/06/01/value-creation-and-value-shifting-in-health-care/

Uwe Reinhardt once again helps us to understand another aspect of the inequitable economics in our health care system by explaining the difference between value creation and value shifting.

Bringing us new beneficial health care services and products creates value, whereas extracting more revenues from the ill without providing any further health benefit shifts value, creating more wealth for the owners of capital (rent-seekers). Value shifting is pervasive throughout our health care system and has been detrimental to the health and finances of middle- and low-income individuals and families.

Reinhardt concludes, “My gratuitous advice to the drug industry, and to the health care industry in general, is to be very mindful of the distinction between value creation and value shifting in their pricing policies, lest they eventually invoke the wrath of the losers in that game, with dire consequences.”

Dire consequences for the health care rent-seekers, anyone? It’s about time.

Why Many Medicare Beneficiaries Cling to an Allegedly Worse Deal

By Uwe Reinhardt, PhD
JAMA Forum, June 1, 2016

Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, Congress granted private Medicare Advantage health plans more money per Medicare beneficiary than it granted traditional, government-run Medicare. In other words, the per beneficiary cost paid by the US taxpayers was higher for those enrolled in the private plans than for those enrolled under the traditional, government-run Medicare program.

In addition to these extra payments from government, the private Medicare Advantage plans are able to cut costs through tactics forbidden to traditional Medicare, such as conducting cost-effectiveness analysis for coverage decisions and offering limited networks of health care providers. As a result, the Medicare Advantage plans have been able to offer Medicare beneficiaries more benefits at lower premiums than what is available to them under traditional Medicare–evidently a better deal.

So it’s not surprising, as a recent JAMA Forum post noted, that the Medicare Advantage program has grown in popularity. Currently, about 30% of approximately 55 million beneficiaries are enrolled in a Medicare Advantage plan compared with only 6% a decade ago.

But even so, about 70% of the approximate 55 million Medicare beneficiaries still prefer the “worse” deal, traditional, government-run Medicare. What can explain this revealed preference?

Freedom of Choice

One answer, as the JAMA Forum post hinted, is that traditional Medicare still offers  beneficiaries complete freedom of choice among physicians, hospitals, and other professionals or facilities providing health care. In contrast, under Medicare Advantage, beneficiaries are confined to the limited network of such health professionals and facilities chosen by their insurer. Concerns have been raised about the adequacy of networks in the plans, and a September 2015 report from the US Government Accounting Office recommended that the Centers for Medicare & Medicaid Services increase its oversight of Medicare Advantage networks.

Does the general US public actually share the idea that freedom of choice among insurers is more important than freedom of choice among physicians, hospitals, and others who offer health care or is that merely the preference of a policy-making elite that forces the public to accept more limited choice for the sake of cost containment? It is an important question in light of the endless debate over restructuring Medicare.

The Issue of Trust

Another factor that may explain the revealed preference among Medicare beneficiaries for traditional Medicare might be the issue of trust.

It is said that in the eyes of US public, government is incompetent and cannot be trusted. But is that really so?

The strong revealed preference for traditional, government-run Medicare suggests quite the opposite. So does the tenacity with which US veterans defend the existence of the Veterans Health Administration health care system, the purest form of socialized medicine in the world; the public’s staunch opposition to privatizing Social Security, their government-run pension system; or even the most conservative state governor’s swift solicitation of assistance from the Federal Emergency Management Agency whenever natural disaster strikes. Would these same governors have the same trust in, say, an emergency management system operated by a consortium of private casualty insurers?

Enrolling in traditional Medicare can be likened to being married to a spouse who, if not generally thrilling, is an always faithful and reliable companion. The social contract under traditional Medicare is not easily changed and can be changed only after much open debate.

By contrast, by their very nature, private enterprises cannot be more than ephemeral companions. They may be acquired by another company with different ideas of management and social obligations, and their contracts with customers are easily changed, at the behest of boards and managers who make those decisions in secret. The limited networks of physicians, hospitals, and other health care professionals and facilities under Medicare Advantage can easily change over time, as can be the benefit packages they offer.

It is good that older adults in the United States have a choice between traditional, government-run Medicare and the private Medicare Advantage plans. Ideally, US veterans would be offered the same choice. But policy makers should think twice before writing off traditional, government-run Medicare, which evidently has served the elderly well enough to remain their most popular choice.

https://newsatjama.jama.com/2016/06/01/jama-forum-why-many-medicare-beneficiaries-cling-to-an-allegedly-worse-deal/

***

Comment:

By Don McCanne, M.D.

Congress has elected to overpay private Medicare Advantage plans in a scheme to entice Medicare beneficiaries out of the public plan and eventually privatize the full program through premium support (vouchers). With the extra funds the private plans are able to bribe patients with lower premiums and supplementary benefits. So why have two-thirds of Medicare beneficiaries refused to fall for this scheme since it would appear to be a better deal for them (though worse for the taxpayers)? Uwe Reinhardt gives us an astute answer, having to do with trust in our government.

Reinhardt ends with the conclusion that it is good to have the choice between the government program and the private plans, especially since it allows beneficiaries to specifically select the trusted government option. In Canada that choice is not allowed for the same reasons that it should not be allowed here. The private version costs taxpayers more, especially because of extra administrative costs due to the more complex private bureaucracies. The private sector also shamelessly manipulates the system to the detriment of those in the public program, a prime example being the ability to enable private patients to jump the queue, leaving the public patients behind. The private sector also is adept at subjecting the public sector to adverse selection, passing more health care costs onto the taxpayers. And so on.

As an interim measure, what we need to do is demand that Congress provide the same level of funding for the traditional program as they do for the private plans so that premiums and benefits can be comparable (actually better since private plan spending is less efficient). They also need to inflict greater penalties on the private plans for their transgressions in unfairly manipulating the system to their benefit. That is, Congress should provide us with an improved Medicare so that it can become the benchmark for a single payer national health program.

Why Many Medicare Beneficiaries Cling to an Allegedly Worse Deal

By Uwe Reinhardt, PhD
JAMA Forum, June 1, 2016

Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, Congress granted private Medicare Advantage health plans more money per Medicare beneficiary than it granted traditional, government-run Medicare. In other words, the per beneficiary cost paid by the US taxpayers was higher for those enrolled in the private plans than for those enrolled under the traditional, government-run Medicare program.

In addition to these extra payments from government, the private Medicare Advantage plans are able to cut costs through tactics forbidden to traditional Medicare, such as conducting cost-effectiveness analysis for coverage decisions and offering limited networks of health care providers. As a result, the Medicare Advantage plans have been able to offer Medicare beneficiaries more benefits at lower premiums than what is available to them under traditional Medicare–evidently a better deal.

So it’s not surprising, as a recent JAMA Forum post noted, that the Medicare Advantage program has grown in popularity. Currently, about 30% of approximately 55 million beneficiaries are enrolled in a Medicare Advantage plan compared with only 6% a decade ago.

But even so, about 70% of the approximate 55 million Medicare beneficiaries still prefer the “worse” deal, traditional, government-run Medicare. What can explain this revealed preference?

Freedom of Choice

One answer, as the JAMA Forum post hinted, is that traditional Medicare still offers  beneficiaries complete freedom of choice among physicians, hospitals, and other professionals or facilities providing health care. In contrast, under Medicare Advantage, beneficiaries are confined to the limited network of such health professionals and facilities chosen by their insurer. Concerns have been raised about the adequacy of networks in the plans, and a September 2015 report from the US Government Accounting Office recommended that the Centers for Medicare & Medicaid Services increase its oversight of Medicare Advantage networks.

Does the general US public actually share the idea that freedom of choice among insurers is more important than freedom of choice among physicians, hospitals, and others who offer health care or is that merely the preference of a policy-making elite that forces the public to accept more limited choice for the sake of cost containment? It is an important question in light of the endless debate over restructuring Medicare.

The Issue of Trust

Another factor that may explain the revealed preference among Medicare beneficiaries for traditional Medicare might be the issue of trust.

It is said that in the eyes of US public, government is incompetent and cannot be trusted. But is that really so?

The strong revealed preference for traditional, government-run Medicare suggests quite the opposite. So does the tenacity with which US veterans defend the existence of the Veterans Health Administration health care system, the purest form of socialized medicine in the world; the public’s staunch opposition to privatizing Social Security, their government-run pension system; or even the most conservative state governor’s swift solicitation of assistance from the Federal Emergency Management Agency whenever natural disaster strikes. Would these same governors have the same trust in, say, an emergency management system operated by a consortium of private casualty insurers?

Enrolling in traditional Medicare can be likened to being married to a spouse who, if not generally thrilling, is an always faithful and reliable companion. The social contract under traditional Medicare is not easily changed and can be changed only after much open debate.

By contrast, by their very nature, private enterprises cannot be more than ephemeral companions. They may be acquired by another company with different ideas of management and social obligations, and their contracts with customers are easily changed, at the behest of boards and managers who make those decisions in secret. The limited networks of physicians, hospitals, and other health care professionals and facilities under Medicare Advantage can easily change over time, as can be the benefit packages they offer.

It is good that older adults in the United States have a choice between traditional, government-run Medicare and the private Medicare Advantage plans. Ideally, US veterans would be offered the same choice. But policy makers should think twice before writing off traditional, government-run Medicare, which evidently has served the elderly well enough to remain their most popular choice.

https://newsatjama.jama.com/2016/06/01/jama-forum-why-many-medicare-beneficiaries-cling-to-an-allegedly-worse-deal/

Congress has elected to overpay private Medicare Advantage plans in a scheme to entice Medicare beneficiaries out of the public plan and eventually privatize the full program through premium support (vouchers). With the extra funds the private plans are able to bribe patients with lower premiums and supplementary benefits. So why have two-thirds of Medicare beneficiaries refused to fall for this scheme since it would appear to be a better deal for them (though worse for the taxpayers)? Uwe Reinhardt gives us an astute answer, having to do with trust in our government.

Reinhardt ends with the conclusion that it is good to have the choice between the government program and the private plans, especially since it allows beneficiaries to specifically select the trusted government option. In Canada that choice is not allowed for the same reasons that it should not be allowed here. The private version costs taxpayers more, especially because of extra administrative costs due to the more complex private bureaucracies. The private sector also shamelessly manipulates the system to the detriment of those in the public program, a prime example being the ability to enable private patients to jump the queue, leaving the public patients behind. The private sector also is adept at subjecting the public sector to adverse selection, passing more health care costs onto the taxpayers. And so on.

As an interim measure, what we need to do is demand that Congress provide the same level of funding for the traditional program as they do for the private plans so that premiums and benefits can be comparable (actually better since private plan spending is less efficient). They also need to inflict greater penalties on the private plans for their transgressions in unfairly manipulating the system to their benefit. That is, Congress should provide us with an improved Medicare so that it can become the benchmark for a single payer national health program.

Patient-Centered Outcomes Research Institute (PCORI)

The Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit, nongovernmental organization located in Washington, DC, was authorized by Congress in 2010.

Our mandate is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. Specifically, we fund comparative clinical effectiveness research, or CER, as well as support work that will improve the methods used to conduct such studies.

The goal of our work is to determine which of the many healthcare options available to patients and those who care for them work best in particular circumstances. We do this by taking a particular approach to CER called Patient-Centered Outcomes Research, or PCOR, research that addresses the questions and concerns most relevant to patients, and we involve patients, caregivers, clinicians, and other healthcare stakeholders, along with researchers, throughout the process.

From the 2015 Financial Report

The Patient-Centered Outcomes Research Institute was authorized in 2010 by the Patient Protection and Affordable Care Act (42 U.S.C. 1301 et seq.) (Act) to “assist patients, clinicians, purchasers, and policy- makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.” It does this by supporting comparative clinical effectiveness research (CER) projects designed to answer questions most important to patients. PCORI is also charged with disseminating the results of that research, focusing on “health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items” studied.

PCORI is a 501(c)(1) tax-exempt, nonprofit corporation, governed by a 21-member multi-stakeholder Board of Governors, including 19 members appointed by the Comptroller General of the United States. By law, the Comptroller General must appoint three members representing patients and healthcare consumers; seven members representing physicians and providers; three members representing private payers; three members representing pharmaceutical, device and diagnostic manufacturers or developers; one member representing quality improvement or independent health services researchers; and two members representing the federal government or the states (including at least one member representing a federal health program or agency). The Act also provides that the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), or their designees, be members of the Board.

How We’re Funded

PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCOR Trust Fund), which was established by Congress through the Patient Protection and Affordable Care Act of 2010. The PCOR Trust Fund receives income from three funding streams:  appropriations from the general fund of the Treasury, transfers from the Centers for Medicare and Medicaid trust funds, and a fee assessed on private insurance and self-insured health plans (the PCOR fee).

PCORI receives 80 percent of the monies collected by the PCOR Trust Fund to support its research funding and operations. The Department of Health and Human Services (HHS) receives the other 20 percent of trust fund monies to support dissemination and research capacity-building efforts (the majority of HHS’s share goes to the Agency for Healthcare Research and Quality).

For government fiscal years (FYs) 2010 through 2012, the PCOR Trust Fund received a total of $210 million total in appropriations from general fund revenues. For FYs 2013 through 2019, the PCOR Trust Fund will receive $150 million from the general fund annually.

http://www.pcori.org

***

Re-evaluating the Patient-Centered Outcomes Research Institute

By Zeke Emanuel, Topher Spiro, Thomas Huelskoetter
Center for American Progress, May 31, 2016

The ACA established PCORI with a clear mandate to carry out the “funding of comparative clinical effectiveness research” over 10 years. PCORI was to focus distinctly on CER and not duplicate the types of research funded by the Agency for Healthcare Research and Quality, the National Institutes of Health, or other entities. However, a Center for American Progress analysis in 2014 found that only one-third of PCORI’s funding was going toward CER.

PCORI studies should have the potential to change clinical treatment decisions or insurers’ coverage determinations. Yet to date, this potential impact on the nation’s health care system has not been fully realized. With PCORI only authorized through 2019, the institute is running out of time to make a significant impact on CER.

Cumulatively since its inception, PCORI has invested 51 percent of its almost $1.4 billion in grant funding in CER, totaling $716 million.

To evaluate whether PCORI’s funding was directed toward high-impact research areas, CAP examined how many of its awards addressed research questions that the Institute of Medicine identified as the top 25 highest-priority CER topics. In fairness, this is not the only relevant ranking of CER needs, and priorities may have evolved since the IOM list was published in 2009. However, the IOM list serves as an authoritative, independent rubric by which to judge whether PCORI is focusing on the most critical evidence gaps in medicine.

In its previous analysis, CAP found that only 12 percent of PCORI’s grants and 14 percent of its grant funding went toward research topics in the IOM’s top quartile. In the new CAP analysis, this first figure declined to 4 percent of grants. However, the percentage of funding allocated to the IOM topics increased to 18.5 percent. IOM top-quartile priority topics cumulatively represent 16 percent of PCORI’s funding to date, representing relatively little change from CAP’s previous analysis.

In response to this analysis, PCORI asserts that 72 percent of the IOM’s top 25 topics have been addressed by a PCORI-funded study, along with 62 percent of the IOM’s top 100 topics. Yet this alternate framing of the issue still leaves almost 30 percent of the top quartile and almost 40 percent of the top 100 unaddressed after several years. Furthermore, this metric explains nothing about whether these studies involved significant or merely minimal funding. Many of these research topics concern broad areas of medicine where many studies are needed; as a result, CAP feels it is important not only that high-impact research topics be addressed but that a significant percentage of PCORI’s funding be connected to such topics.

Thus far, PCORI has not made the impact on the health care system that the drafters of the Affordable Care Act envisioned. The need for CER remains urgent, and PCORI still has the potential to help reduce health care costs and improve the quality of care.

https://www.americanprogress.org/issues/healthcare/report/2016/05/31/138242/re-evaluating-the-patient-centered-outcomes-research-institute/

***

Report: Federally funded institute avoids comparing drugs, other treatments

By Jane O’Donnell
USA Today, May 31, 2016

An institute that pays researchers to compare medical treatments has spent only half of its more than $1.4 billion in available federal money on what is called comparative effectiveness research and has largely ignored prescription drugs, despite their role in driving up health care costs, according to a study released Tuesday by a Washington-based policy group.

PCORI has been criticized since it first appeared in the legislation that became the ACA. Although CER had bipartisan support, the institute got caught in the politics surrounding what Republican former vice presidential candidate Sarah Palin called “death panels” that could decide who received medical treatment.

Now despite widespread concerns about rising drug costs, CER is being attacked by patient groups supported by the pharmaceutical industry that claim the research could limit access to some life-saving drugs.

Congress limited the ability of PCORI to consider costs when comparing health care, drugs or prioritizing research studies.

Patient groups, which are nearly always backed by pharmaceutical companies, are major players in what PCORI decides to research. That can limit the focus on finding lower-cost options, which could hurt the profitability of the companies that pay for the patient groups.

http://www.usatoday.com/story/news/politics/2016/05/31/report-federally-funded-institute-avoids-comparing-drugs-other-treatments/84676320/

***

Comment:

By Don McCanne, M.D.

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit, nongovernmental organization authorized by the Affordable Care Act and funded predominantly by the federal government. They in turn fund comparative clinical effectiveness research (CER), especially through Patient-Centered Outcomes Research (PCOR). The purpose is to determine the relative effectiveness of various clinical approaches, including the comparison of drug therapies. But Congress specifically prohibited a comparison of costs.

Some readers of yesterday’s report on the ICER (Institute for Clinical and Economic Review) were concerned about the potential conflict of interest that could result from the involvement of various stakeholders. The same concern could be expressed about PCORI. Although we have no reason to doubt the integrity of the individuals involved in these organizations, it would be preferred that their organizations have an infrastructure that did not include the influence of vested interests.

An additional concern regarding PCORI is the interference by Congress in preventing crucial determinations about cost effectiveness. Transparency in pricing is essential if we are to ensure value in our health care purchasing.

Another unique feature of PCORI is that it is only a ten year program, scheduled to end in 2019. It is astonishing that members of the policy community, working with Congress, could ever think that we could complete all important comparative effectiveness research by 2019, and that future drugs and technology would not require such reviews.

Just as with ICER, PCORI is under attack by conservatives and by stakeholders, motivated by ideology and by greed. Once again, it appears that, with their influence, the patient is not always being kept foremost in our policy decisions.

We want health care that is the most effective and with the fairest prices. We don’t want health care that gives the most powerful stakeholders a greater advantage in the health care marketplace while also ensuring them a maximum return on their investments. ICER and PCORI seem to be above that, but 100 percent public funding without stakeholder involvement in governance could give us further assurance that their work product is strictly in the patients’ best interests.

Patient-Centered Outcomes Research Institute (PCORI)

The Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit, nongovernmental organization located in Washington, DC, was authorized by Congress in 2010.

Our mandate is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions. Specifically, we fund comparative clinical effectiveness research, or CER, as well as support work that will improve the methods used to conduct such studies.

The goal of our work is to determine which of the many healthcare options available to patients and those who care for them work best in particular circumstances. We do this by taking a particular approach to CER called Patient-Centered Outcomes Research, or PCOR, research that addresses the questions and concerns most relevant to patients, and we involve patients, caregivers, clinicians, and other healthcare stakeholders, along with researchers, throughout the process.

From the 2015 Financial Report

The Patient-Centered Outcomes Research Institute was authorized in 2010 by the Patient Protection and Affordable Care Act (42 U.S.C. 1301 et seq.) (Act) to “assist patients, clinicians, purchasers, and policy- makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.” It does this by supporting comparative clinical effectiveness research (CER) projects designed to answer questions most important to patients. PCORI is also charged with disseminating the results of that research, focusing on “health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items” studied.

PCORI is a 501(c)(1) tax-exempt, nonprofit corporation, governed by a 21-member multi-stakeholder Board of Governors, including 19 members appointed by the Comptroller General of the United States. By law, the Comptroller General must appoint three members representing patients and healthcare consumers; seven members representing physicians and providers; three members representing private payers; three members representing pharmaceutical, device and diagnostic manufacturers or developers; one member representing quality improvement or independent health services researchers; and two members representing the federal government or the states (including at least one member representing a federal health program or agency). The Act also provides that the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), or their designees, be members of the Board.

How We’re Funded

PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCOR Trust Fund), which was established by Congress through the Patient Protection and Affordable Care Act of 2010. The PCOR Trust Fund receives income from three funding streams:  appropriations from the general fund of the Treasury, transfers from the Centers for Medicare and Medicaid trust funds, and a fee assessed on private insurance and self-insured health plans (the PCOR fee).

PCORI receives 80 percent of the monies collected by the PCOR Trust Fund to support its research funding and operations. The Department of Health and Human Services (HHS) receives the other 20 percent of trust fund monies to support dissemination and research capacity-building efforts (the majority of HHS’s share goes to the Agency for Healthcare Research and Quality).

For government fiscal years (FYs) 2010 through 2012, the PCOR Trust Fund received a total of $210 million total in appropriations from general fund revenues. For FYs 2013 through 2019, the PCOR Trust Fund will receive $150 million from the general fund annually.

http://www.pcori.org

***

Re-evaluating the Patient-Centered Outcomes Research Institute

By Zeke Emanuel, Topher Spiro, Thomas Huelskoetter
Center for American Progress, May 31, 2016

The ACA established PCORI with a clear mandate to carry out the “funding of comparative clinical effectiveness research” over 10 years. PCORI was to focus distinctly on CER and not duplicate the types of research funded by the Agency for Healthcare Research and Quality, the National Institutes of Health, or other entities. However, a Center for American Progress analysis in 2014 found that only one-third of PCORI’s funding was going toward CER.

PCORI studies should have the potential to change clinical treatment decisions or insurers’ coverage determinations. Yet to date, this potential impact on the nation’s health care system has not been fully realized. With PCORI only authorized through 2019, the institute is running out of time to make a significant impact on CER.

Cumulatively since its inception, PCORI has invested 51 percent of its almost $1.4 billion in grant funding in CER, totaling $716 million.

To evaluate whether PCORI’s funding was directed toward high-impact research areas, CAP examined how many of its awards addressed research questions that the Institute of Medicine identified as the top 25 highest-priority CER topics. In fairness, this is not the only relevant ranking of CER needs, and priorities may have evolved since the IOM list was published in 2009. However, the IOM list serves as an authoritative, independent rubric by which to judge whether PCORI is focusing on the most critical evidence gaps in medicine.

In its previous analysis, CAP found that only 12 percent of PCORI’s grants and 14 percent of its grant funding went toward research topics in the IOM’s top quartile. In the new CAP analysis, this first figure declined to 4 percent of grants. However, the percentage of funding allocated to the IOM topics increased to 18.5 percent. IOM top-quartile priority topics cumulatively represent 16 percent of PCORI’s funding to date, representing relatively little change from CAP’s previous analysis.

In response to this analysis, PCORI asserts that 72 percent of the IOM’s top 25 topics have been addressed by a PCORI-funded study, along with 62 percent of the IOM’s top 100 topics. Yet this alternate framing of the issue still leaves almost 30 percent of the top quartile and almost 40 percent of the top 100 unaddressed after several years. Furthermore, this metric explains nothing about whether these studies involved significant or merely minimal funding. Many of these research topics concern broad areas of medicine where many studies are needed; as a result, CAP feels it is important not only that high-impact research topics be addressed but that a significant percentage of PCORI’s funding be connected to such topics.

Thus far, PCORI has not made the impact on the health care system that the drafters of the Affordable Care Act envisioned. The need for CER remains urgent, and PCORI still has the potential to help reduce health care costs and improve the quality of care.

https://www.americanprogress.org/issues/healthcare/report/2016/05/31/138242/re-evaluating-the-patient-centered-outcomes-research-institute/

***

Report: Federally funded institute avoids comparing drugs, other treatments

By Jane O’Donnell
USA Today, May 31, 2016

An institute that pays researchers to compare medical treatments has spent only half of its more than $1.4 billion in available federal money on what is called comparative effectiveness research and has largely ignored prescription drugs, despite their role in driving up health care costs, according to a study released Tuesday by a Washington-based policy group.

PCORI has been criticized since it first appeared in the legislation that became the ACA. Although CER had bipartisan support, the institute got caught in the politics surrounding what Republican former vice presidential candidate Sarah Palin called “death panels” that could decide who received medical treatment.

Now despite widespread concerns about rising drug costs, CER is being attacked by patient groups supported by the pharmaceutical industry that claim the research could limit access to some life-saving drugs.

Congress limited the ability of PCORI to consider costs when comparing health care, drugs or prioritizing research studies.

Patient groups, which are nearly always backed by pharmaceutical companies, are major players in what PCORI decides to research. That can limit the focus on finding lower-cost options, which could hurt the profitability of the companies that pay for the patient groups.

http://www.usatoday.com/story/news/politics/2016/05/31/report-federally-funded-institute-avoids-comparing-drugs-other-treatments/84676320/

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit, nongovernmental organization authorized by the Affordable Care Act and funded predominantly by the federal government. They in turn fund comparative clinical effectiveness research (CER), especially through Patient-Centered Outcomes Research (PCOR). The purpose is to determine the relative effectiveness of various clinical approaches, including the comparison of drug therapies. But Congress specifically prohibited a comparison of costs.

Some readers of yesterday’s report on the ICER (Institute for Clinical and Economic Review) were concerned about the potential conflict of interest that could result from the involvement of various stakeholders. The same concern could be expressed about PCORI. Although we have no reason to doubt the integrity of the individuals involved in these organizations, it would be preferred that their organizations have an infrastructure that did not include the influence of vested interests.

An additional concern regarding PCORI is the interference by Congress in preventing crucial determinations about cost effectiveness. Transparency in pricing is essential if we are to ensure value in our health care purchasing.

Another unique feature of PCORI is that it is only a ten year program, scheduled to end in 2019. It is astonishing that members of the policy community, working with Congress, could ever think that we could complete all important comparative effectiveness research by 2019, and that future drugs and technology would not require such reviews.

Just as with ICER, PCORI is under attack by conservatives and by stakeholders, motivated by ideology and by greed. Once again, it appears that, with their influence, the patient is not always being kept foremost in our policy decisions.

We want health care that is the most effective and with the fairest prices. We don’t want health care that gives the most powerful stakeholders a greater advantage in the health care marketplace while also ensuring them a maximum return on their investments. ICER and PCORI seem to be above that, but 100 percent public funding without stakeholder involvement in governance could give us further assurance that their work product is strictly in the patients’ best interests.