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Letter from former presidents of the American Medical Association to PCORI Executive Director Joseph Selby

Written by Thomas Szold

Monday, 27 February 2012 17:10

February 27, 2012
Dr. Joseph Selby
Executive Director
Patient Centered Outcomes and Research Institute
1701 Pennsylvania Ave. NW, Suite 300
Washington, DC 20006
Dr. Selby:

As former presidents of the American Medical Association, we are here to tell you that doctors need your support. As a medical profession, we are under unprecedented pressure from an array of sources. One of these pressures is a growing array of increasingly intrusive government standards and mandates.

Another one is attempting to use the best available evidence to make the optimal treatment decisions with each one of our patients in the face of increasingly aggressive coverage restrictions and utilization management tools. We, as physicians, cannot practice evidence-based medicine when we have a growing array of cost-based restrictions. The question we pose to the Patient-Centered Outcomes Research Institute is whether you will build an agenda that adds to this pressure, or gives doctors support in the face of it. Our plea is that the answer
would be the latter.

Today, we stand concerned that PCORI is taking a direction that could add to the pressure we face. Our concern centers on three issues: First, PCORI’s insistence on advancing a research agenda focused on cost and resource utilization; second, the rushed timetable PCORI has set for finalizing its research agenda; and third, the relationship between PCORI and intrusive CER policies such as the “academic detailing” initiative being pursued by the HHS Agency for Healthcare Research and Quality.

First, we are concerned that by including cost in your research agenda, you will define an agenda that reinforces cost-based access controls, rather than optimal clinical decision-making by doctors and patients. The authors of the Affordable Care Act appeared to share this concern by explicitly defining PCORI’s research mandate to focus on comparative clinical effectiveness research. Physicians and other caregivers were repeatedly assured during the health care reform debate that CER was only about helping doctors and patients make good decisions, not using research to intrude on those decisions. PCORI’s proposed research priorities and agenda appear to ignore this mandate by including consideration of economic factors in the agenda. We understand that any number of rationales can be devised for including cost in your agenda.

However, while we trust this is not your intent, doing so gives the impression of a board of experts that is setting itself above the law because it “knows better.” Most American physicians are aware that governments can use CER results as excuses to ration medical care. In Great Britain, the National Institute of Health and Clinical Excellence (NICE)—a board which is eerily similar to PCORI—conducts research and then recommends to the National Health Service what it should and should not cover in accordance with those results after applying Quality-adjusted life-years (QALYs) with cost as numerator and actuarially determined quality years of life left as the denominator. We ask PCORI to revise its priorities and agenda to focus on better patient care by focusing on clinical and patient health outcomes.

The consideration of cost is going to be problematic for many if not most Physicians. Medical ethics guide Physicians to carefully review all options with pros and cons with their patients and to recommend the treatment that presents the best results for that individual. Problems will arise only if only one alternative based upon cost is all that the physician is allowed to offer to the patient. Sooner or later patients will learn that alternatives with a better promise of cure were withheld and this will destroy the trust that is the foundation of the patient physician
relationship.

Second, we are concerned about the rushed timetable PCORI has set to finalize its research agenda. As PCORI begins its work, nothing is more important in this early stage than making sure you are getting to the research questions and outcomes that matter most to patients and their caregivers. This is a sine qua non in achieving “patient-centered” outcomes research. Yet the timetable set by PCORI will not allow it to get the broad, relevant input it needs from physicians in different clinical specialties and patients with different diseases and conditions.
PCORI should establish a process that allows for broad physician input on specific research questions, and should establish the expert clinical advisory panels that the statute proposes for this specific purpose.

We believe strongly that physician stakeholders are central to achieving PCORI’s goal of patient-centeredness. But we are very concerned that expert physician input could be marginalized in the decision-making process. We hope that PCORI can help support physicians with a role in leadership and include specific mechanisms for providing input and participation on advisory panels. We are concerned that the approach PCORI is taking will leave the real decisions about the research agenda to be made behind closed doors, rather than in the open. This is the wrong approach, and is likely to lead to more status quo, “one size fits all” medicine.

Physicians have based patient recommendations upon outcomes research and best practices for years. Any government involvement should utilize and respect this rich resource. Also all research must be fully transparent so that all findings and recommendations can be openly critiqued and tested by others.

Finally, we request greater clarity and transparency about the relationship between PCORI’s research agenda and CER programs at HHS’ Agency for Healthcare Research and Quality. First, we seek clarity on how PCORI’s agenda relates to AHRQ’s program for “academic” detailing. We are very concerned that this program represents an attempt to put CER in the hands of government contractors to pressure physicians to do what is cheapest on average and not what is best for the individual. As detailed in the President’s recent budget proposal, AHRQ is now receiving tens of millions of dollars annually from PCORI for CER dissemination, yet we have no information on how this money is being spent, and whether it will go towards intrusive programs like “academic” detailing. We trust that PCORI does not intend to support this type of program, but without greater transparency, we have no way of knowing.

In addition, we ask PCORI to provide more details on the role that AHRQ, and AHRQ-funded research centers on the Methodology Committee, played in drafting PCORI’s research priorities. As the PCORI Board has noted, both AHRQ and the Methodology Committee played an important role in this effort. Providing greater transparency about this role is particularly important because AHRQ stands to receive a significant portion of PCORI research funding, and it is important to ensure that the PCORI’s agenda is not skewed in favor of AHRQ funded research programs.

We also are concerned about the substantial funding AHRQ has received and the agency’s unwillingness to engage PCORI in discussions about how to spend the $63 million AHRQ will receive next year to disseminate PCORI’s research. AHRQ is currently sponsoring an academic detailing program that, according to HHS, “promotes appropriate prescribing habits, including the cost-effective use of drugs” and “will help doctors make the right decisions for their patients.” It is important that PCORI make clear to AHRQ, that this type of initiative to communicate PCORI’s research findings is unacceptable, and does not fall within the scope of PCORI’s mandate to conduct research that is focused on the decisions faced by patients and their caregivers.

Physicians have always been hopeful that CER will be done in ways that actually support us in making decisions with our patients. But at the same time we’ve been deeply concerned that the research could easily be skewed towards a government cost-cutting agenda and misused in ways that come between doctors and patients.

PCORI says they’ll be patient-centered, but some of the Institute’s initial decisions are not encouraging. PCORI should execute a strategy beyond conducting “focus groups” and internet surveys to gain essential input from practicing physicians throughout PCORI’s decision making process on what research it should undertake. Practicing physicians play a critical role in helping to identify the most relevant research gaps and can serve as experts in developing a research agenda that considers the questions most relevant to patient and provider needs. PCORI must hear from physicians in real-world practice to ensure CER gets done right.

Please let us know if there is any way we can be of service to PCORI, whose mission of providing patient-centered CER we fully support, and thank you for your hard work meant to improve health care for American patients.

Sincerely,

Donald J. Palmisano, MD, JD, FACS
Spokesman, Coalition to Protect Patients Rights
AMA president 2003-2004

William G. Plested, II MD, FACS
AMA president 2006-2007
Coalition to Protect Patients’ Rights© 2011

Last Updated on Monday, 27 February 2012 19:01

IPAB exists in law, resides in limbo

Written by Thomas Szold

Monday, 30 January 2012 22:17

From Politico, By Joanne Kenen

Chances are the Republicans — and a not-insignificant number of House Democratic allies — won’t be able to kill the Independent Payment Advisory Board this year.

But for another year or two, at least, politicians don’t have to lift a finger to block the Medicare cost-control agency from doing anything. For another year or two, it doesn’t have much to do. Or anyone to do it.

For now, Medicare spending is actually in check — far from the runaway train the Medicare board’s creators had worried about. Its recent growth rate, 5 percent in 2010, puts it on a trajectory much milder than experts had expected.

That means the health program for the elderly is likely to meet its first fiscal target without any help from the yet-to-be appointed independent board of experts. The later years, of course, are less predictable and depend on the economy, the impact of the health care reform law and the inclinations of future Congresses. But in the short term, IPAB’s start date may not matter that much.

“With the sequester that’s scheduled, and changes through the other budget deals, it could keep Medicare under the targeted growth rate. And that’s something to think about, given some of the limitations and structures on IPAB,” said Jack Hoadley, a health policy analyst at Georgetown University.

Those limitations are abundant.

The chances that President Barack Obama and the congressional leadership could find 15 highly competent people who want to serve up to six-year terms under very strict ethics rules on a board the Republicans want to dismantle — and who can muster 60 votes needed for confirmation by the cantankerous Senate in an election year — aren’t too hot.

“It’s very unlikely before the election that they would be appointed,” said Harvard University health politics expert Robert Blendon. “Even if there was the funding to pay for them.”

Joseph Antos, a health policy scholar at the American Enterprise Institute, who is no fan of IPAB, put it this way: “There’s a budgetary issue. A membership issue. And a confirmation issue.”

IPAB’s budget, pared by $10 million in the previous omnibus spending bill, is only one piece of the controversy. The board’s been a hot potato from the beginning — and not just among Republicans.

It was created by the 2010 health care reform law and charged with keeping per capita Medicare spending in check, based on a formula in the legislation. Recommendations were to be developed in 2013, submitted early in 2014, and take effect in 2015, according to a detailed summary of the provisions by health care law experts at George Washington University.

The White House, and then-budget chief Peter Orszag, had pushed to make the board part of health care reform. Advocates said Congress just wasn’t good at dealing with Medicare. Some of the spending decisions are technically complicated. For example, how do a bunch of elected officials know what Medicare should pay for a tank of oxygen, let alone some complex new biologic anti-cancer agent? And lawmakers making those decisions are often lobbied, and lobbied hard.

So the idea was to put some of these decision in the hands of experts — economists, health providers, policy wonks — who have both the technical expertise and the political space to make tough calls. Congress could disapprove on a fast-track process, but it would have to come up with an alternative way of generating the same amount of savings. The board could not recommend changes that would directly affect beneficiaries, such as higher co-pays or taxes.

But some in Congress — including some Democrats who generally back the health care reform law — thought IPAB was a bad idea. They see it as a weakening of congressional authority that puts important national health spending decisions in the hands of unelected technocrats. Rep. Frank Pallone (D-N.J.), for instance, said ceding congressional authority to groups like IPAB illustrates the need to reverse “a growing imperialistic presidency.” And he’s an ally of the president on health care.

Republicans who oppose the health care law take the IPAB argument even further, saying it would damage care quality and move toward rationing.

“Decisions that have significant impact on quality of life — and in the most extreme cases, on life and death — should be made by patients and their doctors. The IPAB would step into the middle of this relationship, and threaten seniors’ access to essential medical care,” Rep. Phil Roe (R-Tenn.), a leader of the repeal movement, has said.

The administration tries to paint IPAB as a backup to congressional decision making, not a replacement.

“The Independent Payment Advisory Board is an important backstop to help reduce Medicare cost growth if Congress fails to do so. The board’s recommendations will go into effect only if Congress accepts them or if Congress fails to act. IPAB recommendations are required when spending is estimated to exceed the benchmark set in the statute,” said Chris Stenrud, a spokesman for the Department of Health and Human Services.

Even if IPAB haters get a repeal vote through the House, a similar initiative would most likely die in the Senate.

So for now, the board is basically in limbo. It will exist in the law. But it won’t have any members, and as of now it has no office or staff, according to HHS.

But in this case, time isn’t of the essence, given the unexpected slowdown in Medicare spending.

Whether that’s a short-term dip, because the economy is forcing people to cut back, or a more permanent reduction in people’s use of medical services is open to debate. But other changes in Medicare finances contained in the health care reform law, plus the 2 percent provider cuts to be “triggered” next year under last summer’s debt ceiling deal, strongly suggest that Medicare spending growth will remain under the IPAB targets at the outset.

The “trigger” — assuming Congress doesn’t repeal it — is bigger than the cut IPAB is allowed to make at first. And the debt deal includes cuts to hospitals, which are off limits to IPAB the first few years.

Whether the sequester cuts will go into subsequent years is uncertain; the next Congress could undo the work of this Congress, Antos noted. And there are a lot of other unknowns about spending trends — and the health care law itself.

But in the immediate future, IPAB is unlikely to be an action item. That could buy time either for a more Republican Congress to try to scrap the board after the elections or for the political controversy to subside a bit until both parties decide to set up the board — or a modified version of it — to deal with Medicare’s long-term fiscal challenges.

Finding people who want to serve could still be a challenge. Six years is longer than most academics can take a leave of absence, and the government salary is lower than some industry-types might want for that length of time. And the conflict-of-interest rules limit the role of doctors, hospital administrators or others who have provided care under Medicare.

“You can’t jump out of the practice of medicine and serve on this,” Hoadley said. “You will have to have a certain independence and be at a certain stage of life and be willing to go into the political maelstrom. You will be up there making recommendations that lots of people will dislike.”

If anyone’s being sounded out to serve on the board, it’s happening quietly. When POLITICO asked a few people in the policy world about any names that were circulating or who might want it, the answer was typically: “Not me!”

Last Updated on Monday, 30 January 2012 22:26

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