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Missing Pieces of Health Reform

By Michael D. Miller MD
February 23rd, 2010

At a briefing in Washington DC this morning, two very well respected and reasonable economists talked about how the increasing prevalence of chronic diseases and care delivery in outpatient settings are driving up costs in Medicare.  They also asserted that a greater focus on real cost containment - and possibly cost reduction - should be the focus of health reform, and that this could be achieved by increasing team based care coordination and increasing personal responsibility for care and costs, among other focused initiatives that might require political courage…..which one of them noted appears to be currently in short supply.

Their conclusions and analyses are all well reasoned and reasonable, but having listened to these types of analyses and briefings for more than 20 years I was stuck by two things.  First, what they were saying wasn’t significantly different from what people had been saying for, well, more than 20 years.  And second, like most presentations about health reform, they focused on what needs to be changed but didn’t talk about how to create that change - except to focus on altering economic incentives.  (It is worth noting that one of the panelists recommended that government programs such as Medicare should consider not just creating incentives for people and providers to do certain things, (like use electronic medical records),  but rather should say, “if you want to get paid by us, you will do things this way.” Clearly this type of ‘my way or the highway’ approach can be effective, but it also faces much higher political barriers because it could result in a number of doctors and other care providers being excluded from Medicare.)

Motivators Other Than Economic Incentives
What also struck me about their focusing on economic incentive as the driver of change is that this can work for some people and organizations, but in healthcare, there are other factors driving people’s behavior - particularly the behavior of patients and community practicing physicians.  For patients, if they were to act the way economic models would predict, (i.e., always in their best economic interests), everyone would brush their teeth and floss more often, exercise regularly and rarely eat anything that came out of a frozen box or a deep fryer.  But such economic modeling assuming that people act based upon full knowledge AND that their economic interests are the overriding force behind their decisions.  And in the real world, neither of those assumptions are true.

So what’s missing from the health reform prescriptions based upon changing economic incentives for physicians, patients and others?  First,  increasing relevant and useful information can help increase the impact of whatever economic incentives are created.  For example, showing physicians that their practice patterns are different that their local peers can help motivate them to change how they care for certain conditions in ways that economic incentives may not.

And second, non-economic motivators for behavior change can be created that are aligned with  financial incentives (and disincentives) to change actions and attitudes.  These types of motivators are particularly important for individuals - whether they be patients or individual physicians.  In addition, initiatives to change individual behaviors and actions need to recognize the 80-20 rule, where 80% of people go one way and 20% don’t.  In promoting care delivery changes it might be more accurate to call it the 10-70-20 rule, where 10% of clinicians are early adopters, followed by another 70%, with 20% resisting the adoption.  Thus, the key to changing clinical practices at the individual level, (i.e. getting real world clinicians to adopt the care practices of “evidence based medicine” that health reformers talk about), is to get the early adopters to rapidly adopt the better care practices, and for them to become active  teachers and proselytizers for these changes with the receptive 70% of their peers.  (Note: the early adopting 10% are sometimes called change agents or agents of change.)

The remaining 20% who resist change should slowly be convinced by their peers resulting in longer term improvements. And in the shorter term, getting 80% adoption of changed care practices that improve quality and reduce costs would equate to some tremendous improvements for patients and society.

Returning to the Book
How to develop and implement initiatives involving such non-economic motivators and pair them with economic incentives to transform healthcare delivery - resulting in increased quality and reduced costs - is a core part of the book I’ve been writing.  Unfortunately, I’ve been trying to figure out how to make the book relevant within the rapidly evolving health reform environment over the last 2+ years.  Now that the dynamic has shifted back to fiscal responsibility and cost containment, and health policy is all about health politics, it may be time to finish the book so that it will be available for policy makers and stakeholders when health reform initiatives return in 2011 and beyond. If you have any thoughts or suggestions about these issues or the book, please feel free to comment here or contact me at the physical or email addresses on my contact page.

Posted in Delivery of Healthcare, Economics & Financing, Health System Reform | No Comments »

Doctors Communications to Patient’s Family

By Michael D. Miller MD
February 10th, 2010

The great writer John McPhee’s article in the February 8th issue of the New Yorker is primarily about his experiences fishing for pickerel in New Hampshire, but the subtext is his connecting to his dying father who is in the hospital after a severe stroke.

While the article is extremely warm and heart-felt, two short sections stand out because of his visceral reaction to his father’s doctor:

“His room had a south-facing window.  My mother, in a flood of light, eighty-seven, looked even smaller than she was, and space was limited around her, with me, my brother, my sister and a young doctor together beside the bed. I was startled by the candor of the doctor.  He said the patient did not have many days to live, and he described cerebral events in language only the patient, among those present, was equipped to understand.  But the patient did not understand: ‘He can’t comprehend anything, his eyes follow nothing, he is finished,’ the doctor said, and we should prepare ourselves.

“Wordlessly, I said to him, ‘You fucking bastard.’ My father may not have been comprehending, but my mother was right there before him, and his words, like everything else in those hours, were falling upon her and dripping away like rain.  Nor did he stop. There was more of the same, until he finally excused himself to continue on his rounds.”
……
“The young doctor returned, twenty-four hours exactly after his earlier visit. He touched the patient with his fingers and steel, and qualified for compensation. [emphasis added] He said there had been no change and not to expect any; the patient’s comprehension would not improve. He went on as had the day before.  My father, across the years, had always seemed incapable of speaking critically of another doctor, perhaps in a paradoxical way, because he had been present in the operating room where the mistake of another doctor had ended his mother’s life. Even-tempered as he generally appeared to be, my father could blow his top, and I wondered, with respect to his profession, to what extent this situation would be testing him he were able to listen, comprehend, and speak.”

To be fair - and maybe overly fair - perhaps the physician taking care of Dr. McPhee was focused on the outcome of his patient, and realizing that improvement would not happen wanted to set realistic expectations for the family. However, what is clear from John McPhee’s prose is that the physician didn’t see the patient’s family within his care continuum.  He didn’t treat them as if they were his patients who needed his compassion.  If he had, he might have realized that while he - and medical science - could do very little for Dr. McPhee after his stroke, there was a lot that he could do for the family by being more compassionate and empathetic in his interactions as he was explaining the diagnosis and prognosis.

In addition - although John McPhee doesn’t mention it in his article - hopefully there were other components of the care team besides the one physician, since a well-coordinated care team should provide additional information and support to the family.  It would be unrealistic for a single physician to provide all the information and support to a critically ill patient and their family - even when there is no hope and no interventions to ease the patient’s condition. Expecting a physician to do all this alone is like asking an NBA basketball player to go 1 on 5 against another team.  Even the greats of Chamberlain,  Jordan, or Bryant wouldn’t have been able to do that.

I applaud John McPhee for his great writing and for including his direct feelings about his encounter with the medical care system.  His article would be good reading for clinicians in training and practice since it so deeply illuminates how patients and their families can view clinicians, their words, and how they deliver them. Similarly, his article would be a great reading for students and policy makers interested in the relationships and communications between clinicians and patients - and their families - as well as for those interested in improving compassionate caregiving.

Posted in Clinician-Patient Relationships, Delivery of Healthcare, Information & Communications | 2 Comments »

Miscommunicating the Government’s Powers for Health Reform

By Michael D. Miller MD
February 8th, 2010

The Virginia state legislature recently passed a law making it illegal “to require individuals to purchase health insurance.” This action reminded me how commonly the extent of governmental powers are misperceived.

The Virginia legislature’s action follows those in other states, and are in line with the “tea party” groups’ opposition to the general direction of national health reform. But what exactly it means for a government’s actions to be “illegal” is also unclear. And as Tuesday’s Washington Post article on the Virginia bill states, “it would have little practical impact because it would be preempted by federal law.” Thus, the actions in Virginia and other states are more political than substantive, and seem to be more about the states’ laying down markers should they later want to take the Federal government to court over any individual mandates for buying or having insurance.

Powers of the Government
Hidden underneath this political discussion of the “illegality” of health insurance mandates is exactly what the government can and cannot do to force or entice people to do things.  And while academic and legal scholars may take some issues with my simplified description of governmental powers, there are basically four broad options for what governments can do to try and change people’s actions:

1. Attack
Making war, (or other type of overt or covert intervention), is probably the most dramatic of the Federal government’s powers, but presumably doesn’t have a role for health reform and mandates for buying insurance, etc.

2. Incarcerate
The government does a great job of putting people in jail, but I haven’t heard anyone talking about jail time as a penalty for failing to have health insurance.  However, healtcare for prisoners has been a potent political and policy issue at different times.  For example, it was a key message in Harris Wofford’s victorious 1991 special Senate election in Pennsylvania when he noted that if prisoners had a right to healthcare then so should all Americans. And at a much more granular level, there have been cases where prisoners have tried to stay incarcerated so they could get care for health problems because if they were freed they would have been uninsured.

3. Money, Money, Money
Money is the lever governments uses most frequently for non-criminal activities, such as health insurance, housing, food, etc…  At the most basic level governments can either give money, (e.g., tax credits, food stamps), or take it away, (e.g., higher tax rates, fines, penalties, or denial of tax deductions or credits, etc.). And the mechanisms for giving or taking money can be divided between taxes and cash - or cash equivalents like housing vouchers.

For example, in Massachusetts, the individual and employer health insurance “mandates” are enforced by financial penalties, i.e. not jail time.  Similarly, fiscal incentives for individuals and states to have or provide health insurance are very common, e.g. the increase in Federal Medicaid matching rates included in the 2009 stimulus law.

Of course, there are often strings attached to the receipt of money or benefits because neither governments nor private citizens are in the habit of leaving cash in a bag for someone to pick up and do with what they please. That is why government programs have participation requirements just as private contracts have provisions for what must be done before money is exchanged.

4. Talk the Talk
The last tool governments can use to influence actions is the power of the speech, persuasion, and illustrative illumination.  Elected and senior appointed officials have the advantage of having their words amplified through the press. Such officials can also identify individuals and companies who have done good things, as well as not-so-good things.  This type of individual identification can be very powerful, but may also be politically dangerous if praise is directed towards those who has skeletons in their closet, (either literal of figurative), which then become public.

The last type of tool that governments can use to change the world is to use government program operations and purchasing decisions to lead by example. This type of Walk the Walk action is a combination of money and talk, and an example is the State of Massachusetts using their state employees’ health benefits program to advance quality of care by using information about individual physicians to create incentives for employees to go to physicians who are rated the highest in quality. This initiative was controversial but it survived a court challenge in the State, unlike a similar initiative in New York State.

Leading by example is often not as simple as creating targeted economic incentives, because such actions can run into government procurement rules, international treaties, union contracts and other legal limitations on government actions - which may be why this tactic is not commonly used for driving public policy changes.

Conclusions
While the Federal Government has considerable power and resources, the history and legal system of the United States limits governments’ powers so that giving and taking money is the primary tool used to enforce “mandates” and “requirements.” The result is that people, companies and even state and local governments have a choice - comply with the Federal rules and get the money, or don’t and don’t get the money, or maybe even lose some money.  For example, as I noted in my last posting, the State of Arizona didn’t get any Federal matching funds for Medicaid for over 15 years because they chose to not have a Medicaid program.  Similarly, the mandates in Massachusetts for having health insurance are “enforced” by tax penalties for individuals and businesses - although the number of people and companies effected has been relatively small because of the exemptions for smaller companies and affordability for individuals.

Leading by example - either in how they run their internal operations or their procurement/contracting - is an option which governments have used less often to advance specific policies. In a time of fiscal constraints, leading by example might be a good way to leverage limited Federal money and resources - particularly around the contentious issue of health reform where it could help demonstrate the positive value of better healthcare benefits and care delivery for employees, organizations and society.

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Politics | 1 Comment »

The Path Forward for National Health Reform

By Michael D. Miller MD
January 31st, 2010

The path forward for health reform is becoming clearer now that the dust from the Democrats losing their 60th vote in the Senate is settling.  While a freestanding, comprehensive law now seems very unlikely, achieving the core goals of health reform are possible via the regular order of a Reconciliation bill, demonstrations and pilot programs, waivers, existing authorities, and the appropriations process.

It’s the Stupid Economy
First, the President has appropriately reraised jobs and the economy to be his highest priority.  This shift may both help defuse the hyperpartisaness that has enveloped health reform, and increase action to improve the economy and create jobs since they are the source of the public’s ongoing angst and frustration.  However, the Administration and Congress should continue to pay attention to health reform since people’s concern over the economy and job-lock are partially driven by worries about the affordability of health insurance and healthcare.  In addition, location-lock for small businesses and entrepreneurs because of different state health insurance laws may be supressing job growth in those sectors… something I recently investigated in moving from Massachusetts to DC.

Reconciliation - Part 1
Second, any action related to health reform will need to embrace fiscal responsibility and deficit reduction.  This clearly points towards a Reconciliation bill that reduces the growth in Medicare spending, (and extends its solvency), along with some Medicaid changes to accommodate increasing enrollment while limiting States’ fiscal exposure in a down economy.  This type of Reconciliation bill would be similar to those that both Democratic and Republican controlled Congresses have passed in the last 20 years.  (In the current political alignment, Democrats will have to counter Republicans’ accusations that they are cutting Medicare rather than just slowing spending growth. Both characterizations are “true” depending on your political objectives.)

Strategic Demonstrations, Pilot Programs and Waivers
Just nipping and tucking at Medicare spending and increasing Medicaid’s enrollment and financial support to the States won’t meet anyone’s definition of health reform.  Therefore, to move the US health system along the path of reform to expand coverage, improve quality and control costs, there are targeted initiatives that the Administration and Congress can pursue to push forward with reforming health delivery and financing:

First the Administration can get much more aggressive with its use of Medicare demonstrations and pilots. These can build upon the HIT and CER programs included in last year’s stimulus bill as stepping stones for health reform.  The Administration already started in this direction with their “Demonstration Grants for the Development, Implementation, and Evaluation of Alternatives to the Current Medical Liability System” announced last September.  Granted this program was designed to provide some cover for Congressional moderates and to probably curry favor with some clinician groups, but the Administration also has the ability - and in some cases the legislative authority - for many other types of demonstrations and pilots.  For example, they could:

  • Proceed rapidly with the Advanced Primary Care (APC) model type of Medical Home demonstration they announced last September - and which I wrote about previously.
  • Resurrect the straightforward Medicare Medical Home demonstration that Congress authorized in 2006 for eight locations. (In 2008 authorization was expanded to as many locations as HHS wants.)  This demonstration was scuttled last fall because the evolving health reform legislation had language replacing it with two new ones.  Since the draft regulations for this program were completed in December 2008, they would just need to be updated and finalized for the program to start later this year or January 2011.  There is also no reason that this Demonstration couldn’t run in parallel with the APC Medical Home demonstration - perhaps in different geographic locations.

For these and other demonstrations and pilot programs, the key for success will be structuring them somewhat like clinical trials so that people and organizations are assessing very similar, if not identical things.  This would not be “cookbook medicine” since these demonstrations should focus on the organization of care delivery and not on individual care decisions. For example, the Medical Home demonstrations mentioned above are about the organization of services provided by primary care practices, not the specific decisions made by clinicians for individual patients.  Similarly, the use of surgical checklists is an operational process that has been shown to reduce errors, increase the quality of care, and reduce costs.  However, it does not specific what procedures the surgeon performs or how the anesthesiologist delivers medicines, etc.

One of the failings of past demonstration programs has been that they have been structured to analyze what people are already doing rather than ways of delivering care that might improve outcomes. For example, the Medicare care coordination demonstration that reported its “conclusions” last year failed to demonstrate very much since it was an evaluation of 15 different types of programs.  In addition, demonstrations are sometimes caught up in significant political and parochial interests.  This was the case for a demonstration program involving “Centers of Excellence” for cardiac care at hospitals.  This demonstration program was scuttled the first time around - and hobbled thereafter - because the hospitals in the demonstration’s geographic locations not deemed “Centers of Excellence” complained quite strongly - particularly to their Members of Congress.

Thus, evaluating what people and organizations are already doing is easy, but may not provide much useful information since care organizations tend to vary greatly in how they operate, even within local areas, so drawing specific conclusions from these types of semi-focused studies is difficult.  Conversely, evaluating specific care practices is harder because it requires changing day to day activities for clinicians and providers, but this type of more controlled experiment can actually demonstrate the value of a change.  And lastly, any of these demonstrations can be undermined by political or parochial forces so that the demonstration is stopped, delayed, or its requirements so diluted that the conclusions are of little value. Thus, to make these demonstrations valuable, career and political officials need to be diligent and have fortitude when they are developing, approving, and overseeing the creation and implementation of such demonstrations and pilots.

Expanded Use of Existing Authority
Once research projects have demonstrated and validated improved ways of delivering care, Medicare, (and possibly Medicaid and other Federal programs), could use their existing authority to pay more for the adoption of these changes - or pay less or not at all when they are not adopted.  For example, Medicare and private payers have stopped paying for so-called “never events,” i.e. clinical events that are completely avoidable and thus should never happen.  Similarly, it is probably within Medicare’s existing authority to not pay - or pay less - for surgeries or the insertion of central intravenous lines when a validated checklist is not used.  These checklists are process steps that have been proven to work and yet have not been universally adopted, which raises the question as to why Medicare is paying for clinical situations where these improvements are not used.

Medicare and Medicaid Waivers
Beyond demonstrations and pilots, and the use of existing authorities, Medicare and Medicaid waivers are other tools that can be used to implement significant changes. Waivers for Medicaid are much more common, and the entire Medicaid program could be viewed as a 50+ bags with 1,000+ waivers.  Technically these waivers are intended to “demonstrate” better ways of running Medicaid programs that would provide information for changing all Medicaid programs across the country.  In practice, these waivers have proliferated like Tribbles in a storage bin of triticale grain, with most States using many waivers for different aspects of their Medicaid programs.  (For example, Arizona didn’t have a Medicaid program until 1982 when it created its program under a statewide waiver. And Massachusetts’ health reform expansion law was only possible because of a revised/renewed Medicaid waiver.)

Medicare waivers are less common than Medicaid waivers, but can be more powerful.  For example,  Maryland’s Medicare waiver has enabled the state to run an all-payer rate setting system for hospitals for many years. And in the near future Massachusetts may be seeking a Medicare waiver to implement an all-payer bundled payment system that their Special Commission recommended last July.  Such a state-wide payment reform system would be an even more dramatic health reform step than the state’s insurance coverage expansion and coverage mandates. But it remains to be seen if the Massachusetts legislature will proceed with this important cost containment and quality improvement step - and if they can get a Medicare waiver when they are ready to ask for it since the Federal Government’s attitude toward such waivers may be different in 2012 or 2014 than it might be today, or was last summer.

Reconciliation - Part 2
It is clear that cost containment for Medicare, expansion of Medicaid, a flurry of demonstrations, pilots, waivers and the use of existing authorities would not constitute significantly health reform since even all together those initiatives would not significantly advance progress towards universal insurance coverage - a fundamental goal of health reform. And one of the criticisms of using the Reconciliation process in the Senate has been that the insurance expansion provisions and coverage mandates in the House and Senate bills would be stripped out under the Reconciliation rules.

However, having successfully included provisions in a Reconciliation bill when I was told that they would definitely be stripped out, I know that under the peculiar rules of Reconciliation all numbers that are the same are are not equal, and there are ways to configure provisions and their implementation to effectively achieve the following:

  • Implement significant and strong regulations/requirements/standards to prevent insurance and coverage denials, and pricing problems that are currently permitted under various loose state laws;
  • Create strong incentives for insurance coverage for most, if not all Americans;
  • Provide subsidies for low income people and small businesses to make health insurance affordable; and
  • Reduce the so-called “donut hole” in the Medicare drug benefit.

The first three of these are really the fundamental parts of health reform, and improving Medicare’s Part D benefit is a widely agreed upon goal. The other aspects of the legislation that was moving through Congress are important, but not really essential - and the public plan option has always been redundant and politically explosive pair of suspenders alongside the belt of strong insurance regulations.  In addition, these provisions are also supported by two of the major industries that could have opposed health reform - insurers and biopharmaceutical companies.

There may be some who would criticize the first three of these changes as causing prices to go up, etc. as they transform the health insurance marketplace in most states, but the reality is that this would replicate what has happened in Massachusetts - first with their insurance reforms in the early 1990s, and more recently with their coverage mandates and expanded low-income subsidies.  And despite some public rhetoric, it is working very well, people like it, and it provides stability and security for insurance coverage.  What it hasn’t done is address costs - which is why the state is looking at an all-payer bundled payment system which would give clinicians, provider organizations, and others  incentives to control spending without being intrusive into their care practices.

Paying for these legislative changes will of course be a challenge, but with a renewed focus on fiscal and social responsibility for the Federal Government and financial institutions, there are innovative ways to have all these health reform changes not result in an increase in the Federal deficit.

Conclusions:

  • The Administration and Congress should be making the economy and jobs their #1 priority, but should continue to work on health reform since health costs and the vagaries of the health insurance system continue to fuel people’s angst about job security and the overall economy.
  • Significant health reform can be done without massive restructuring in one sweeping bill.  Rather coverage can be expanded and costs controlled by constantly pushing and shoving, and massaging and tweaking. Many successful government programs have been built and improved over many decades using such an “incremental” approach - so it is a valid avenue for improving such a complex, multipronged, pervasive, and sinewy “industry” as healthcare.
  • Important and significant provisions were included in last year’s stimulus law, and additional government actions should be viewed as building on those initial steps.
  • Change is hard, but explaining the immediate and long-term benefits for individuals and society will be important for deflecting politically driven mischaracterizations.  In addition, pointing to Massachusetts’ success with insurance regulation and coverage expansion should demonstrate that such changes work in the real world.  And while many other parts of the country point to Massachusetts as a liberal, “Taxachusetts,” socialist enclave, the state’s recent election of Republican Scott Brown to serve the remainder of Ted Kennedy’s Senate seat should fully refute that mischaracterization.  If a state can elect Scott Brown, then they can’t be all that knee-jerk, socialist-liberal.

Next Steps
The next steps in the annual Federal legislative dance will be the release of the President’s budget proposal tomorrow, followed by the start of the Congressional budget process. The two things to remember about the President’s budget proposal are that it was written and locked up before the Massachusetts Senate election, and this document is generally as much about making political points and sending specific messages as it is about the numbers for specific programs and initiatives. That is, within the Administration’s overall 3 year freeze on non-security discretionary spending there will certainly be proposals for program increases and decreases, but it is Congress that actually makes these determinations. Thus many of the numbers and programmatic initiatives in the President’s budget proposal may be designed to score points with specific groups and to force Congress to make the hard decisions about where to get additional funding for its favorite programs that the President’s budget proposes cutting. For those who thought that President Obama would somehow transform or transcend the Washington political process this may come as a bit of a shock, but the reality is that the framework of the Constitution and the evolving nature of the US government and society promote the separation of powers and a balancing act among them, which at times can look something like an uncivil war.

Posted in Delivery of Healthcare, Health System Reform, Medicaid, Medicare, Politics | No Comments »

Checklists and Physicians’ Behaviors

By Michael D. Miller MD
January 12th, 2010

I recently heard Dr. Atul Gawande talk about his new book “The Checklist Manifesto.” While the evidence demonstrating the value of checklists for improving the quality of healthcare is increasingly abundant, in his presentation Atul talked about how in a study assessing a surgical checklist they ran into resistance from about 20% of physicians.

Another story he told involved his surgical group’s considering how they might manage bundled reimbursements, e.g. accepting a single payment for all the care and testing related to thyroid cancer surgery.  Their discussions came to a screeching halt when it became clear that this “might” mean less money for each of the surgeons. This uncertainty in personal income arose because accepting bundled payments would require them to distribute money among the people and organizations involved in the actual surgery, the pre and post surgical testing, and the follow-up, which can be a very complicated process.

His group of surgeons probably found this change too daunting because they didn’t have an overarching group/entity to help them assess how to distribute/divide a bundled payment, and actually manage and monitor the money and their financial performance.  While they are part of Partners in Boston - a large integrated health system that includes the  Mass General and Brigham and Women’s hospitals - it seems that Partners hasn’t reached the point of providing this type of support for their individual medical groups.

In the broader world of health deliver reform, to manage such bundled payments effectively physician groups might need to become part of - or affiliate with/have relationships with - medical homes and/or accountable care organizations.  If every group of physicians - particularly in a single specialty - had to figure out on their own how to accept and manage bundled payments, it is very unlikely to work, leaving us with our current perverse incentives of fee-for-service reimbursements that promote volume over quality.

What these two stories have in common is that they involve the barriers to positive transformations of clinical medicine.  Specifically, fee-for-service’s financial incentives give many clinicians few reasons to change to bundled payments or other reimbursement systems that don’t prioritize volume and don’t reward quality outcomes. Similarly, increasing the use of checklists and other care improving protocols faces significant barriers because while they don’t attack clinicians’ incomes, they can be seen as assaulting their professional autonomy.

Change Agents and Care Delivery Transformation
Part of the solution to both these challenges are support mechanisms to assuage clinicians’ concerns about loss of income and autonomy.  The simplest way to conceptualize these support mechanisms is as “Change Agents.”  For bundled payments, clinicians need some trusted group or organization that can help them understand how they will be compensated, what information they will get and how to use it, and how bundled payments may actually simplify their professional lives and even potentially increase their incomes - assuming they can practice more efficiently and effectively. For example, because medical care has become so complicated - with an ever expanding array of advanced diagnostic and therapeutic options - the use of checklists and protocols can help clinicians standardize the routine parts of care and thus cognitively free them up to focus on patients’ individual needs and goals, including how to optimize adherence to treatment plans. These changes will improve clinical outcomes, which is what patients want, and economic outcomes, which is what society wants because it will help stimulate the economy and make it easier to expand insurance coverage and access to care.

While Change Agents to support the successful adoption of bundled payments may be some combination of administrative groups and other clinicians who’ve successfully used the new reimbursement scheme, Change Agents for care innovations are most often other clinicians.  Typically these clinician Change Agents have real world experience showing how the innovation has actually improved the quality of care - particularly by saving an individual life or preventing a specific adverse event. (Dr. Gawande’s research group saw this in their surgical checklist study, and I found this in researching the use of telemedicine in intensive care units.)

Patients as Change Agents
Patients can also be Change Agents.  As I’ve previously written, if patients asked their doctors if they use checklists for things like surgery and inserting central IV lines, and then refused care from physicians (or institutions) that don’t use such checklists, there would likely be rapid adoption of these and other innovations as they are validated and their value communicated broadly.  Advocacy organizations can also fill this role, as can government agencies as part of their quality improvement activities through programs such as Medicare, Medicaid and the Veterans Health Administration - something I’ve also raised in a previous post.

Conclusions
Improving quality and slowing the grow in healthcare costs will require multipronged strategies.  What these strategies will have in common is that they will confront the significant barriers clinicians have in changing how they practice medicine.  Achieving this will require Change Agents - clinicians, patients, advocates, and government agencies who can demonstrate and support the value of care innovations.  Simple? No. Possible? Yes.  But as the pair of old sayings go: If it was easy anyone could do it. And if it was easy, someone would have done it already.

Posted in Delivery of Healthcare, Economics & Financing, Quality of Care & Safety | 1 Comment »

Thanksgiving Conversations About Health - Engage With Grace Blog Rally

By Michael D. Miller MD
November 24th, 2009

For many years I’ve used the Thanksgiving dinner table conversation as a model for discussions about healthcare - but usually I’ve put it in the context of people who work for healthcare companies, (e.g. pharmaceutical or managed care), trying to address, rebuff and rebut the criticisms they might get from family members, (e.g. Aunt Lilly), about the problems with the US healthcare system and the actions or positions of various companies or industries.  However, last year - and again this year - several bloggers have been cooperating to promote Thanksgiving weekend discussions about end of life care issues.  This effort has been called the Engage with Grace, and last year it was a great success, with over 100 bloggers participating.

The original mission of this “blog rally” was to get more and more people talking about their end of life wishes. But because this year has had quite intensive public debate about health reform, the decision was made for this year to do something a bit different and add a bit of levity to the efforts to promote discussions.

At the heart of Engage With Grace are five questions designed to get the conversation started, but to put a slightly lighter spin on these questions, the first set below has a less serious tone - the “real” Engage With Grace questions are at the end of this post - and I’ve interjected five other humorous ones in between. They’re not easy questions, but they are important - and the goal of both the serious and lighter questions are to get people talking, since if you can’t talk about the funny questions, then how can families and friends expect to seriously talk about the difficult and important ones?

Engage With Grace Questions - Set 1

  1. Which one of your family members would you trade for a celebrity or professional athlete, and who would you trade them for?
  2. After you made that trade, would you want the celebrity or professional athlete to cook or do the dishes at your holiday meal?
  3. Would you want that celebrity or professional athlete to be on your post holiday meal team for Charades or Monopoly?
  4. Would you want that celebrity or professional athlete to be named on your advanced directive or living will so they could make decisions about your healthcare needs and choices if you were unable to do so?
  5. Would you want that celebrity or professional athlete to represent you in the US Congress to make decisions about Medicare and health reform?

Engage With Grace Questions - Set 2

Have a good holiday season - and go with grace.

Posted in Clinician-Patient Relationships, Delivery of Healthcare, Miscellaneous | 3 Comments »

Cost and Coverage c. 1989-91: Part 2 of Historical Perspectives on Health Reform

By Michael D. Miller MD
November 17th, 2009

As I mentioned in my last post, in going through old files I found many memos and articles about health reform.  Some of them from 1989-91 illustrate the long history of the challenge of controlling costs and providing care for more people - and eerie similarities to the current debate:

For example, below are some pieces of text from articles and commentaries published in the New England Journal of Medicine from January 1989 - October 1990:

  • “A Consumer-Choice Health Plan for the 1990.  America’s health care economy is a paradox of excess and deprivation.  We spend more than 11 percent of the gross national product on health care, yet roughly 35 million Americans have no financial protection from medical expenses. To an increasing degree, the present financing system is inflationary, unfair, and wasteful. In its place we need a strategy that addresses the whole system, offers financial protection from health care expenses to all, and promotes the development of economically financing and delivery arrangements. Such a strategy must be designed to be broadly acceptable in our society. To remedy this deprivation, we propose that everyone not covered by Medicare, Medicaid, or some other public program be enabled to buy affordable coverage, either through their employers of through a ‘public sponsor.’ … The U.S. health care economy is inflationary. It is still dominated by fee-for-service payment of doctors and hospitals by third party intermediaries with open-ended sources of finances. There is no total budget set in advance within which providers must manage the care of their patients. For the most part, there is no incentives to find and use medical practices that produce the same health outcome at less cost.” (1/5/89 -  Enthoven and Kronick)
  • “A National Health Program for the United States: A Physicians’ Proposal. Our health care system is failing.  Tens of millions of people are uninsured, costs are skyrocketing, and the bureaucracy is expanding. We propose a national health program that would (1) fully cover everyone under a single, comprehensive public insurance program; (2) pay hospitals and nursing homes a total (global) annual amount to cover all operating expenses; (3) fund capital costs through separate appropriations; (4) pay for physicians’ services and ambulatory services in any of three ways: through fee-for-service payments with a simplified fee schedule and mandatory acceptance of the national health program payment as the total payment for a service or procedure (assignment), through global budgets for hospitals and clinics employing salaried physicians, or on a per capita basis (capitation).” (1/12/89 - Himmelstein and Woolhandler)
  • “Sounding Board: It Is Time for Universal Access, Not Universal Insurance. … Universal health insurance is not a good idea.  To control goods and services through a single agency - especially when the driving force is economic - would fly in the face of the American way of doing things. … Rather than support such unworkable, soulless programs, I propose universal access through a pluralistic funding mechanism. … So, we ought not to be talking about a universal health insurance scheme, but rather about universal access - access to needed care, on a timely basis, with controls on quality and use that have been accepted by everyone involved.  The key principle of effective access and limited cost is the rationalization of care.  In this age of high-technology medicine and miracle drugs, we must realize that we can no longer do everything for everybody just because it is possible. Rather, we should develop a system in which decisions about what we do, when, where, and to whom are based on reasonable expectations of the benefits involved and on sound medical principles communicated clearly to patients and their families.” (7/6/89 - James Todd, MD - American Medical Association)
  • “Special Report: The Pepper Commission Report on Comprehensive Health Care. A look at the outcome of the commission’s deliberations give a good indication of what, in fact, it takes to build political consensus. The commission basically face two separate tasks - reform of the nation’s existing system for insurance medical or health care, and creation of a system for insuring assistance in the task of daily living we call long-term care. The commission voted overwhelmingly (11 to 4) in favor of a major government initiative in long-term care. … By contrast, the commission’s vote on health care reforms - universal coverage for people under the age of 65 (at a cost of $24 billion) and measures to promote the efficient delivery of health care - passed by the slim margin of eight to seven. … The difference between the commission’s votes on long-term care and health care, then reflects the many and pointed political pressures that will work against consensus on health care reform, not for it. … First, and most obvious, the vast majority of commission members face reelection campaigns this fall… … Second, and related, in the wake of the traumatic repeal of Medicare catastrophic coverage, members will remain acutely sensitive to potential voter reaction to any particular reform package. Third, in health care there are entrenched political interests. … Fourth, with a complex issue such as this, consensus on the whole requires many, many concessions on individual provisions. … Finally, outright partisan politics will undermine consensus on health care reform, as the commission found in the days preceding the vote, when the White House placed intense pressure on some members to resist any consensus before the November elections. … If we do not act promptly, I believe our health care system may well implode by the end of the century.   The need for action is starkly clear.” (10/4/90 - Senator John D. Rockefeller IV, Chairman of the Pepper Commission)

And other articles from 1991 show similar perspectives on health reform and the urgency for action:

Washington Post, February 17, 1991 “Devising a Cure for High Costs of Health Care: Support Grows for Concept of National Medical Insurance. … The idea [of government-imposed universal health care that would provide quality coverage for everyone], in various forms, is gaining the support of groups ranging on the political spectrum from the AFL-CIO and the American Association of Retired Persons to the National Association of Manufacturers and the American Medical Association.  For the first time since the mid-1970s, supporters of national health insurance believe they have a legitimate chance of winning congressional approval for a universal health care bill, if not this Congress, then the next. ‘This is the best shot we’ve had in 15 years,’ said a key congressional aide. With health care costs climbing more than 20 percent a year for major corporations and even more for many small businesses, disparate political groups are beginning to form a coalition for reform.

USA Today, March 11, 1991 - “Health care costs more, serves fewer.  No other part of the US economy seems less understood than health care.  Few realize why health care costs are so stubbornly high ($2,700 per American per year) or why health care seems to defy free-market economics. … What a growing number of people are coming to know is dissatisfaction with a health care system that absorbs ever-soaring sums of money while letting more and more people fall through the cracks. …  Of all the cold showers of reality falling on the USA as the ’90s dawn, none is as chilling as this: The healthcare system in this country is in deep, deep trouble.”  (Graphic shows that of the 37 million people in the USA without health insurance 49% are working adults.)

Bottom Line - The more things don’t change the more they sound the same.

Next Up: Part 3 - Perspectives from a 1992 Medical School Class “The Crisis in the American Health Care System”

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Health System Reform | 2 Comments »

Historical Perspective on Health Reform - Part 1, Medical Effectiveness

By Michael D. Miller MD
November 16th, 2009

Since the time-line for health reform legislation has continued to be stretched, I recently spent some time cleaning out old files.  In my excavations I came across papers, articles, memos and briefing books which demonstrate that no matter how much things change, some aspects of health reform have stayed the same.  For example, below are a couple of snippets from memos about a proposed Medical Effectiveness Initiative from circa 1989:

Establishing a Medical Effectiveness Initiative at the OASH [Office of the Assistant Secretary of Health] level. (FY90 request = $52 million) This initiative would assess which medical treatments are cost-effective, and identify inappropriate and unnecessary medical practices. This knowledge would be used by reimbursing agencies in containing health care costs. [FYI – for budgetary comparisons, FY89 budget authority for the NIH was $7.15 billion, and $536 million for the FDA, and $141 billion for HCFA - now CMS.]

The Secretary’s Effectiveness Initiative for promoting the public health has as its goals:

  • improving the quality of health care received by Americans through the provision of effective, appropriate care, and involving the consensus of the medical community;
  • control of health care costs through elimination of ineffective and unnecessary medical treatments and comparison of the cost-effectiveness of alternative treatment modalities, thus insuring access to care;
  • enhancing the scientific basis of medicine through application of current technology (e.g. meta analysis; mainframe and software design) to the issues of medical treatment effectiveness; and
  • enhancing the competitive basis of the health care industry through provision of information to patients and providers on risks and benefits, including cost-effectiveness of medical treatments.

While the budgetary size of the proposal is very small compared to current initiatives, (e.g. the $1.1 billion for Comparative Effectiveness Research enacted earlier this year in the stimulus legislation), the wording and rationale for the proposals sound very similar - except that this initiative would explicitly use the information to alter government reimbursement  practices, which was precluded under the ARRA bill.

One difference that dates this language is the phrase “mainframe and software design.”  There have been significant advances in computer technology - which we now term IT - and these advances enable much better and rapid monitoring of quality, as well as and spending and utilization.  Such near real time quality and cost monitoring is important for implementing programs that provide cost and quality information to clinicians, patients, payers and others.  The ability to deliver analyses based on information which is days, weeks or maybe a month or two old, and reflects individual actions, is much more effective for changing behaviors and practice patterns than is data which is years old, and may be aggregated information for a population or across a region.  In addition, IT advances have made risk adjustment a much more robust process - if not exactly precise.  This is critical for the success of quality improvement and cost control programs because the first response from every clinician presented with information that the care they provide is costlier, or somehow lower in quality, than their peers’ practice patterns is that their patients are more severely ill than average and that explains why their costs are higher and outcomes poorer.

Next Up: Part 2 - Historical Perspectives on Universal Coverage and Cost Containment

Posted in Comparative Effectiveness, Delivery of Healthcare, Public Health | 1 Comment »

Morphing Medical Homes into Advanced Primary Care Model

By Michael D. Miller MD
October 18th, 2009

The concept of patient centered medical homes (PCMH) has been evolving since it was first presented by 4 primary care medical societies, (AAFP, AAP, ACP & AOA), in March 2007.  Since then, the PCMH concept has been endorsed by many other medical societies and interest in PCMHs has grown.  Some of the significant steps forward have included:

  • The National Committee for Quality Assurance (NCQA) created specific requirements and a certification procedure for PCMHs
  • Several states are moving forward with PCMH pilot projects
  • Congress passed a law for Medicare Demonstration projects and the Department of Health and Human Services created draft guidelines for these projects - however, these guidelines haven’t been finalized although the demonstrations were scheduled to start in 2010

Steps Sideways
Along with all the interest and activity related to medical homes, there has been a blurring of the definition about what constitutes a medical home.  For example, the definitions of a medical home in the Medicare Demonstration’s draft materials are somewhat different than the NCQA’s criteria. And in various venues others have presented their modifications on what a patient center medical home needs to - or should - look like.  And most recently, HHS announced an initiative “that will allow Medicare to join Medicaid, and private insurers in state-based efforts” using the “Advanced Primary Care model (APC), also known as the patient-centered medical home.”

This new initiative is interesting for at least two reasons: It may be giving PCMHs a new name, and it will not replace the previously unstarted Medicare Demonstration which, according to a healthreform.gov fact sheet about the initiative, will move forward on its own. [FYI - CMS’s website for that demonstration hasn’t been updated since April and doesn’t reflect the APC initiative.]  Whatever the connection between the two demonstration projects, I hope that the powers that be at CMS avail themselves of the groundwork already laid in the draft materials for the original Medicare only PCHM demonstration, since the HHS press release states that, for the new APC concept demonstration, “The Centers for Medicare & Medicaid Services will develop application materials later this fall with the expectation that the demonstration programs begin next year.”

With Greater Interest (and Funding) Comes Pressures to Bend
This entire time-line - from the 4 Medical Societies agreeing to the “Joint Principles of the Patient-Centered Medical Home,” to the current initiative which seems to rename PCMHs as Advanced Primary Care - reflects the morphing of medical homes because of economic and political interests from outside groups that hope to benefit from new medical home based funding.  The blurring of the definition of medical homes may enable some groups to be eligible for those funds with a minimum amount of effort.  The policy counter argument will be that by having many different types of medical homes  in demonstration projects will provide the best evaluation of what works best.

The shapes and sources of those pressures for “diversity” of definitions, and how they have led to changes and delays in different programs, are often hard to tell, but their effects will likely be seen in the demonstration programs’ final forms…. if they ever get started.  And looking forward, the next point of attack for these pressures will likely be the demonstration programs’ data collection and evaluation processes, since similar vested interested will want to show how various features of APC practices (or PCMHs) are important for improving quality and reducing costs - or not.

Posted in Delivery of Healthcare, Health System Reform, State-Level Healthcare Reform | 4 Comments »

Off-Label Communications: Is More Less?

By Michael D. Miller MD
October 4th, 2009

Allergan corporation has filed a law suit against the Federal government challenging the FDA’s limits for companies discussing or promoting off-label uses of approved medicines.  This is not a new issue, but the news reports indicate that Allergan is going very old school and basing their legal challenge on Constitutional freedom of speech rights.

The issue is not can doctors and patients use approved medicines for conditions, (or in ways), which are not specifically approved by the FDA, but can companies discuss these off-label uses with physicians or provide them with published information about these off-label uses?

Competing Risk-Benefit Perspectives
The competing risk-benefit perspectives that surround this issue are nearly identical to the trade-offs that all stakeholders in biomedical research and development face - including the FDA, companies, patients, clinicians, and legislators:

  • Creating a landscape that protects individuals and public safety
  • Being flexible enough to provide clinicians and patients access to the best available treatment possibilities
  • Providing companies a reasonable market environment that creates incentives for developing new treatments and investigating new uses for already approved medicines, which also has marketing rules that are as clear as possible so companies can conduct business without being excessively concerned about straying into regulatory gray zones

Off-label use is common in clinical practice - particularly for disease areas like cancer - because it often represents the standard of care.  And in situations where a medicine approved to treat a common condition has an off-label use for a rare condition, the company has very little incentive to conduct the expensive and time-consuming clinical research to get the FDA to approve that rare off-label use.

There are a few key points underlying the issue of communicating information about off-label uses:

  1. The Constitutional freedom of speech rights for a company are not as expansive as for an individual
  2. The FDA’s regulatory authority focuses on the approval for sale and marketing of medicines, (and some other product areas), and not their use in clinical practice - with some very rare exceptions
  3. The FDA’s position about companies disseminating information about off-label uses has not be fixed in stone

On this last point, the 1997 FDA Modernization Act included a provision to expand the ability of companies to give physicians journal articles and similar material about off-label uses of approved medicines.  After that the Washington Legal Foundation brought a law suit seeking to expand off-label information dissemination.  And when the FDAMA provisions expired in 2006, the FDA proceeded with rule-making guidance to replace the FDAMA provisions, and this final guidance became effective in January 2009.

Not having read the details of Allergan’s legal challenge - and since the FDA doesn’t comment on current suits - it’s hard to assess the specific pros and cons of their positions.  But considering the extensive legislative and case law involving this issue, the company certainly seems to have a very steep hill to climb.  On the other hand, it would seem unusual that they would spend the time and money to bring a legal challenge unless they felt they had a chance to prevail. However, Allergan’s suit may have implications for the FDA, industry, clinicians, and patients for several or many years - even if they lose - because they may be making a pretty big splash in the policy pond with such a public challenge to change the rules for off-label promotion, and this will likely alter the landscape for any future actions.

I was involved with a somewhat analogous situation in the mid-1990s where a lot of groundwork had been done to prepare for a substantive debate about reforming a fundamental life sciences policy issue.  However, one company had an urgent and particular need for a legislative change, and they proceeded to pursue every reasonable and extraordinary avenue for getting the change they wanted.  The end result was that all our subsequent discussions were short-circuited because every policy stakeholder’s response upon raising this issue, was “Oh, I know about THAT issue,” with the implication that it was something they wanted nothing to do with because of the controversy the one company had stirred up with their expansive activities.  (I’ve purposefully not named the issue so as to not perturb anyone or any company about something that happened years ago.)

Collective Sausage Making
The moral of this story is that to make productive changes stakeholders within and across groups frequently need to work together. And if they don’t, the well can easily get polluted for everyone when policy makers avoid any action because they connect the issue to a nasty smell.  This may be another manifestation of the old adage, “the two things that shouldn’t be seen being made are laws and sausages.”

Happy Sausage Making - 2009

Posted in Delivery of Healthcare, FDA, Information & Communications, Quality of Care & Safety | No Comments »

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