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Health Reformers Have Stumbled Into A Trap Of Their Own Making

As I’ve blogged about before (here, here, here and here), a big reason reform is going so badly is this:  Reformers don’t understand how people react when you try to make changes to their health benefits.

Companies across America have been making changes to health benefits for years.

Reformers seem to have ignored the lessons of their experience.

Take one of the hottest trends in benefits – evidence-based plan design.

These are plans that offer better coverage if care is done based on evidence-based guidelines.  It’s similar to the “comparative effectiveness” ideas that are so important to some of the reform proposals.

The National Business Group on Health published a study of challenges companies face implementing these plans.   The study tried to understand how employees feel about these kinds of changes to their benefits.

Here are three of the major findings.

1.  Most employees believe that more care is better care. Employees tend to view the idea that sometimes less care is the right care as “both unfamiliar and counter-intuitive.”  Quality care is viewed as “trying as many things as possible, including new or alternative treatments.”  In other words, you get what you pay for, and efforts to pay less are interpreted as efforts to give less.

2.  Employees are suspicious of their employer’s motives. Employees tend to assume that their employer just wants to save money, and doesn’t really care about the quality of care they get.  They suspect that moving to an evidence-based plan design is really just the first step toward more severe restrictions on choice and access.

3.  Employees worry that employers are overstepping their bounds. Employees report worries that their employer wants to influence treatment decisions. They feel strongly that those decisions should be made by them and their doctor.

Reformers made a big mistake by focusing so intently on health care cost savings as the “single most important fiscal issue we face as a country.” It’s almost as if they decided to pick a way to promote reform that would create the most resistance.

Spend less on health care?  That was almost certain to be understood as meaning you want to deny me or my loved ones the care we deserve.  A panel of government experts deciding what treatments are effective?  Who are they to tell me and my doctor what’s right? And don’t you dare tell me the reason you want to do all this is to make sure I get the best care.

Reformers have stumbled into a trap of their own making.  Based on the continuing effort to demonize those who raise objections, they still don’t see it.

This is why reform is going so badly.

*This blog post was originally published at See First Blog*

Hot Topics In Healthcare Reform: A Primer

For those of who believe there is a pill for every ill, the recent flurry of legislation and ensuing debates on health care reform may be just too big a pill to swallow.

You’ll need a very large glass of water for sure.

“There’s a lot to consider and not everyone is going to like everything about this legislation,” Rep. Lois Capps (D-CA) told participants at Avalere Health’s conference on Raising the Bar:  Payment Reform and CV Disease on Friday, June 12 in Washington.  Capps, a 20 year veteran school nurse, co-chair of the Democratic Heart and Stroke Caucus and member of the House Energy & Commerce Health Subcommittee describes the pending legislation in terms of “choice” and “a balance” but readily admits that finding a way to pay for it will be difficult.

For those who might not feel up to speed on the latest buzz on health care reform, here’s a quick primer:

Public Option. To cover the 47 million uninsured or underinsured Americans, the President is asking for a public plan that would compete within the insurance market place either directly on cost, or indirectly with clout.  Supposedly, this plan (yet to be included in the Senate HELP health reform legislation introduced last week but rumored to be coming in the markup) will be subject to the same rules and regulations of the private health insurance market.  It could be an extension of Medicare, Medicaid or a hybrid of approaches involving capitation and integrated systems for physicians and hospitals.

The debate about whether or not to introduce a new public option to the current health insurance system involves more than a sense of fairness or simply closing the gap.  The private insurance business is strongly tied to state regulations and competitive forces that will remain as long as 15% of Americans purchase their insurance out of pocket and another 40% have insurance through employment .  Designing the right form of public assistance that can compete with private insurance but not control the market place is surely to reflect the strong differences between political parties.

Centralists in Congress, namely Sen. Kent Conrad (D-ND), have proposed co-ops as a third approach between a public option and the status quo.  Co-ops are membership-owned and operated non-profit organizations that adhere to state laws for health care coverage and provide health insurance for individuals and small businesses.  Reaction has been mixed but some believe co-ops will hit the right balance of competition and public assistance needed for passage in the Senate.

Comparative Effectiveness. Comparative effectiveness research seeks to compare the clinical effectiveness of two alternative therapies for the same condition.  It’s rooted in the idea that our system of paying for the volume (e.g., “fee-for-service”) should be replaced with payment for effectiveness and value that is based on the best science possible.  Recent examples of comparative effectiveness research include trials comparing bare metal coronary stents to drug-eluting stents and comparing older versus newer drugs for treatment of schizophrenia.   All this can be extremely valuable to clinicians and patients trying to decide between alternative courses of treatment.  And to the extent that comparative effectiveness research improves the quality of care, it can also reduce costs.

But clinical data alone cannot reflect patient preferences or whether a treatment course for the overall population is the best one for an individual.   The hot button here is how to encourage clinical research that can help physicians and patients make the best treatment choices yet safeguard it from being used by insurance companies and the government to deny coverage or set payment.  What, exactly, will be compared needs close scrutiny.

Accountable Care Organizations (ACOs). An ACO is a combination of one or more hospitals, primary care physicians and possibly specialists, who are accountable for the total Medicare spending and quality of care for a group of Medicare patients.   Various carrots and sticks are being discussed, but the idea is to control Medicare spending and improved quality of care.  While most physicians recognize the need to move away from Medicare’s fee-for-service approach, the incentives and infrastructure needed to coordinate among providers isn’t apparent.  What about rural areas where coordination of care is a misnomer?  This may be a hot topic for systems change, but practitioners are skeptical.

Patient-Centered Care. It’s hard to imagine that the American College of Cardiology felt the need to launch a new initiative, the “Year of the Patient” or the British Medical Journal depicted tango dancers on its cover story, “Partnering with the Patient” but re-infusing the health care debate from the patient’s perspective is long overdue.   Look for it in every piece of legislation, new commission and advisory group.  Raising the voice of a few on a plum commission or panel discussion  is a laudable start, but we’re all, at one time or another, patients.  We’re all consumers of health care and drawing upon our own experiences to improve our professional stance will be necessary.

Gateways. The Senate HELP Committee’s legislation introduces the concept of “gateways” or “exchanges”, a clearinghouse of sorts on a state level to help consumers parse through insurance plans and public services.  The program would be optional for states for the first six years then federal compliance would prevail.  Organizations such as Kaiser Family Foundation have already established online “gateways” (www.healthreform.kff.org) to inform consumers wanting to know more.

Health reform is coming fast and furious.  On Monday, June, 15, the Congressional Budget Office is expected to release their projections on what it will take to pay for such massive reforms.  Hospitals and physician groups are deeply concerned about cuts in Medicare payments – estimated by the President on his weekend radio chat as an additional $313M on top of the $309M included in the Administration’s FY2010 budget.

Further legislation will be released this week; keep an eye on the Senate HELP Committee, Senate Finance Committee, House Energy & Commerce, House Ways & Means, and House Education and Labor.

There’s much more to health reform than covered here.  I encourage you to find a passion point of entry and share your insights.

And get ready to swallow a very big pill.

Here’s a quick list of what’s hot in health care reform:

  • Public Option
  • Electronic Medical Records
  • Elimination of pre-existing exclusion
  • Patient-Centered Care
  • Accountable Care Organizations
  • Payment based on value not volume
  • Integrated health delivery systems
  • Federal Health Board
  • Transparency in data, costs and outcomes
  • Personalized health care/personalized information
  • Chronic care models/Transitional Care Models
  • Prevention and wellness programs
  • Comparative Effectiveness
  • Payment reform/Medicare cuts
  • Shared decision making

Comparative Clinical Effectiveness Research: Setting Priorities At The IOM

What would it be like to have most of healthcare’s key stakeholders in one room, and allow each of them to take turns at a podium in 3 minute intervals? It would be like the meeting I attended today at the Institute of Medicine.

The goal of this public forum was to allow all interested Americans to weigh in on prioritization rankings for comparative clinical effectiveness research (CCER). CCER, as you may recall from my recent blog post on the subject, is the government’s new initiative to try to establish “what works and what doesn’t” in medicine. Instead of answering the usual FDA question of “is this treatment safe and effective?” We will now be asking, “is this treatment more safe or more effective than the one(s) we already have?”

There are many different treatments we could study – but let’s face it, 1.1 billion isn’t a whole lot when you consider that some CCER studies (like the ALLHAT trial) cost upwards of 100 million a piece. So we have to think long and hard about where to channel our limited resources, and which treatments or practices we want to compare first.

The public forum attracted most of the usual suspects: professional societies, research organizations, industry stakeholders, health plans, and advocacy groups. But the imposed time limit forced them to really crystallize their views and agendas in a way I’d never seen before.

I “live-blogged” the event on Twitter today and if you’d like to see the detailed quotes from all the presenters, feel free to wade through the couple of hundred comments here.

For those of you more interested in the “big picture” I’ll summarize my take home points for you:

Almost everyone agreed that…

  1. The process for establishing research priorities should be transparent and inclusive of all opinions.
  2. More information is good, and that CCER is a valuable enterprise insofar as it provides greater insight into best practices for disease management.

Most agreed that…

  1. Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
  2. CCER should be considered separately from cost effectiveness decisions.
  3. One size doesn’t fit all when it comes to patient needs and best disease treatments.
  4. Physicians should be included in the CCER research and clinical application of the findings.
  5. Research must include women and minorities.
  6. CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
  7. CCER should build upon currently available data – and that all those who are collecting data should share it as much as possible.

Some agreed that…

  1. There is a lack of consistent methodology in conducting CCER.
  2. We need to be very careful in concluding cause and effects from CCER alone.

The best organized 3 minute presentations:

In my opinion, the industry folks had the best presentations, followed by a powerful and witty 3 minutes from the American Association for Dental Research. Who knew the dentists had such a great sense of humor? Here are the top 4 presentations:

#1. Teresa Lee, AdvaMed – best all around pitch. In three short minutes, Teresa persuasively argued for transparency in CCER priority-setting, presented her top disease research picks (including hospital acquired infections and chronic diseases like asthma, diabetes, and clinical depression), the importance of physicians and patients making shared decisions about care (rather than the government imposing it), and the need to distinguish CCER from cost effectiveness.

#2. Randy Burkholder, PhRMA – “Without physician input, the questions we pose via CCER will not be clinically relevant.”

#3. Ted Buckley, BIO – “What’s best for the average patient is not necessarily best for every specific patient.”

#4. Christopher Fox, American Association for Dental Research – he said that “his good oral hygiene made it possible for him to deliver his presentation today.”

Most innovative idea

Dr. Erick Turner of Oregon Health and Science University suggested that FDA trial data be used as the primary source of CCER-related data analysis rather than the published, peer-reviewed literature since journals engage in publication bias – they tend to publish positive studies only.

Most shocking moment

Merrill Goozner, from the Center for Science In The Public Interest, essentially told the public forum hosts that the event was a terrible idea. He suggested that industry stakeholders were inherently biased by profit motives and should therefore not be allowed to influence the IOM’s CCER priority list. The crowd squirmed in its seats. For me, Merrill’s suggestion was like saying that a plan to reform the auto industry should exclude car manufacturers because they have a profit motive. Sure profit is a part of it, but reform is just not going to happen without buy in and collaboration. As I’ve argued before – there’s no such thing as complete lack of bias on anyone’s part (patients, doctors, nurses, dentists, health plans, advocates, or industry). The best we can do is be transparent about our biases and include checks and balances along the way – such as inviting all of us biased folks to the table at once.

I’m glad that happened.

Comparative Clinical Effectiveness Research: How Will It Impact Healthcare?

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

A Game-Changer For Pharma, Medical Technology, and Biotech

There is no doubt that CCER stands to radically change how industry does business. I anticipate that industry will develop their own internal CCER teams, and begin the process of comparing their new product (to others currently available) as early as phase 3 clinical trials. By and large, that’s probably a good thing – though there are potential unintended consequences that deserve mention.

While it’s appropriate for drug, device, and equipment manufacturers to consider whether or not their new product actually contributes something new/better to our current cadre of treatment options, there will be clear winners and losers in this game. And when companies lose, we lose companies. That’s generally not good for the economy. Manufacturers without diversified product lines are more likely to go out of business – and it will become more difficult for new players to enter the marketplace.

Although comparative clinical effectiveness research is distinct from comparative cost effectiveness research – it is likely that payers will use CCER to build their formularies. This means that even though the government (at this point in time) is not mandating coverage decisions based on CCER, health insurers are going to be using the information liberally to justify coverage preferences and even potential denials of coverage.

There’s also the question of stifling innovation. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.

As Dr. Rich argues in his excellent blog: healthcare rationing is inevitable – but it’s more ethical to do it overtly than covertly. I would also like to suggest that insofar as physicians can be enlisted to translate CCER for patients (rather than being handed down inflexible rules from on high) and help them make the best decision for them – that would be even better. The inflexibility of national decisions about healthcare rationing does make me nervous.

What’s Good For The Geese Isn’t Necessarily Good For The Goose

First of all, most key healthcare stakeholders would like to be able to compare efficacy of one treatment option over another. Informed decision-making is hard to do when head-to-head studies are simply not available for most treatment options.

However, population-based conclusions do not always provide a clear “best choice” for individual patients. Individual genetic differences, allergy profiles, complicated drug regimens, unique constellations of diseases, socioeconomic factors, and psychological issues all influence clinical decision-making.

Dr. Nancy Nielsen recently voiced concern about CCER at the Medicare Policy Summit. She said that the AMA’s position is that CCER is for information purposes, not for coverage decisions. CCER’s goal is to help patients make informed choices, not limit their choices. I’m afraid the horse may have already left the barn on that one – but I agree with Dr. Nielsen’s sentiment. It would be wonderful if CCER could remain in its supportive role for shared physician-patient informed decision-making. My fervent wish is that in doing the right thing by the geese, we don’t kill off the occasional goose. Physicians need the flexibility to make exceptions when necessary for their patients.

Republican Unrest

A certain degree of hysteria related to CCER has recently wafted up through the hallowed halls of government. Are republicans overreacting to the bill? Maybe – though the bill doesn’t include any provisions for using CCER to mandate coverage decisions or ration care, it seems that Pete Stark has made it clear that he’d like the FCC to “direct medicine” which does kind of send a shiver down my physician spine, and provides some insight into what some democrats are hoping to accomplish with CCER – laying the foundation for future government involvement in the diagnosis and treatment of patients.

Also one particular congressional report is proving helpful in “reading the tea leaves” regarding the democrats’ plan for CCER. In describing the comparative effectiveness provision, the report states that items, procedures, and interventions “that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”

While congressional reports are not binding, they do give an indication of intent.

The bottom line is that though CCER is not supposed to be used for “cost effectiveness” decisions – there’s no policy in place to protect that from happening.

Conclusion

Information about the comparative clinical effectiveness of treatment options is critical for the practice of evidence based medicine. Such information supports informed decision-making, and could be the single most important strategy for reducing the use of wasteful or ineffective therapies in healthcare.

On the other hand, CCER will certainly have some negative consequences, both anticipated and unanticipated. When “cost effectiveness” conclusions are drawn from clinical effectiveness data, rationing ensues, patient choices are limited, people lose their jobs, and some companies go out of business. As a recent article in the New England Journal of Medicine points out, “saying no isn’t nice.” I greet this 1.1 billion dollar initiative with muted enthusiasm.

Post Script

In my research for this blog post I came across some interesting quotes. I thought I’d add them here for your consideration:

***

And before you tell me we need such bills in order to be more scientific, take a minute and ask yourself just how scientific you think the government will be when it applies cost-cutting measures to medicine.  The congress is certainly a hot-bed of evidence-based legislation, isn’t it?

– Edwin Leap, M.D.

When things go wrong, which of course they will, we reach for 2 tools to try to fix them: rules, and incentives. We see this at work in our response to the current financial crisis – but the truth is that neither rules nor incentives are enough to do the job.

When we turn increasingly to rules and incentives, they may make things better in the short run but they create a downward spiral that makes them worse in the long run. Moral skill is chipped away by an over reliance on rules that deprive us of the opportunity to improvise and learn from our improvisations, and moral will is undermined by an incessant appeal to incentives that destroy our desire to do the right thing.

Without intending it, by appealing to rules and incentives we are engaging in a war on wisdom.

Don’t get me wrong, we need rules. Most Jazz musicians need some notes on the page, and we need more rules for the bankers, God knows. But too many rules prevent jazz musicians from improvising and as a result, they lose their gifts – or worse, they stop playing altogether.

We need incentives – people have to make a living. But over-reliance on incentives demoralizes professional activity. It causes people who engage in that activity to lose morale, and it causes the activity itself to lose morality.

– Barry Schwartz, Ph.D. from his lecture at TED

AMA President Dr. Nancy Nielsen At The Medicare Policy Summit

nancy-nielsen-ama1I attended my very first Medicare Policy Summit conference today – and it was truly riveting (wonk alert). I took copious notes and will do my best to summarize some key points in a series of blog posts. This first post is devoted to the presentation by AMA President, Dr. Nancy Nielsen.

Dr. Nielsen began her lecture with an amusing story. She said, “congressional hearings are pure theatre” and described what she’d experienced three months ago at a meeting with Pete Stark. The conversation went something like this:

Stark: I’m sick of rich doctors driving up in their Porsches saying ‘I’m pulling out of Medicare.’

Nielsen: [Thinking to herself: First witness please?] I drive a GEO jeep.

Then Dr. Nielsen looked out at the Medicare Policy Summit audience and asked, “are there any doctors here?” I raised my hand enthusiastically at the back of the room. Then she responded, “Oh thank God. Well, you know we’re in the lion’s den…”

[Parenthetically, I didn’t see anyone else raise their hand – which is the subject for another conversation.]

What Is The AMA’s Current Agenda?

1. To expand coverage for the uninsured

2. To reform the physician payment system

3. To improve the quality and safety of healthcare

4. To improve public health

What Is The Bee In Nielsen’s Bonnet?

Nielsen explained that the sustainable growth rate is unsustainable. She stated:

“We can’t go through the annual death dance with congress over this. There is another 21% across-the-board cut in Medicare reimbursement scheduled for January 2010. And this cut will affect a group of small business owners (aka physicians) whose reimbursement has not increased since 2001 while their costs have increased 20%.”

What Does Nielsen Propose We Do?

1. Reform the system so that it reimburses for care coordination and prevention

2. Craft solutions based around patients’ needs

3. Rebase the SGR

4. Bundle services to increase value and reduce costs

5. Invest in disease prevention and wellness

6. Use comparative effectiveness to inform clinical decision-making (but NOT as a basis for coverage decisions)

7. Bring physicians into the policy decision-making process

Closing High-Five to Nurses

Dr. Nielsen closed with an amusing anecdote about inauguration day. Apparently she was standing in the sidelines of the parade route where Biden got out of his limo to greet the crowd. He gave a big hug to some nurses standing next to her and said, “I love nurses. They’re so much better than doctors.” Dr. Nielsen then had the opportunity to introduce herself to Biden and he responded, “Doctors saved my life, but nurses gave me the will to live.”

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