Historical Perspective on Health Reform – Part 1, Medical Effectiveness

Posted on November 16, 2009 by Michael D. Miller MD

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

Morphing Medical Homes into Advanced Primary Care Model

Posted on October 18, 2009 by Michael D. Miller MD

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.

Off-Label Communications: Is More Less?

Posted on October 4, 2009 by Michael D. Miller MD

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:

The Constitutional freedom of speech rights for a company are not as expansive as for an individual
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
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.”

Bending the Cost Curve: Trees and Forests

Posted on September 25, 2009 by Michael D. Miller MD

Bending the curve of cost growth has been a expanding issue within health policy discussions – as opposed to the public plan option, which has increasingly been the focus of political health discussions. Recognizing how important cost growth is to health reform, the September/October issue of Health Affairs is dedicated to this topic, and it contains great articles describing various factors causing spending to grow faster than the GDP or general inflation, and some solutions to this ongoing conundrum. However, these articles are like trees in the forest, i.e., they are very important, but a close examination of each one doesn’t provide a broad understanding of the whole forest – or in this case, what bending the curve of healthcare cost growth might look like.

Below are summaries of five of the Health Affairs articles – all are worth a close read. And following that are some illustrations of what bending the curve could look like based upon current projections for healthcare costs, GDP, and inflation.

Trees Within the Forest – High Cost Growth Causes and Cures
Five very interesting articles that describe various aspects of the causes of and cures for health spending growth from the current issue of Health Affairs are:

Henry Aaron’s and Paul Ginsburg’s “Is Health Spending Excessive? If So, What Can We Do About It?” is a clear, concise and extremely useful article that would be a great read for students and policy-makers. Their article has two excellent tables. The first covers common questions (and answers) about health spending. And the second describes the factors contributing to the growth in health spending, (arranged in into the groups of: Demand, Supply, Institutions, and Research), and notes whether policy changes to specific factors within these groups “can or should” reduce the growth in health care spending.

Arnold Milstein’s and Elizabeth Gilbertson’s “American Medical Home Runs” describes 4 primary care organizations that have successfully reduced costs without reducing quality. Examining these sites, they found the leaders driving changes had 4 elements in common: persistence, tolerance for risk, instinct for leverage on clinical and economic outcomes, and personal accountability. (For those who have studied healthcare system and culture change, these elements shouldn’t be too surprising.)

John Toussaint’s “Writing the New Playbook for U.S. Health Care: Lessons from Wisconsin” describes the ThedaCare hospital system’s application of the Institute of Healthcare Improvement’s “lean manufacturing” principles, and how it led to dramatic reductions in waste and quality improvement – primarily by using team-based care to eliminate unnecessary steps in care delivery. His article notes that physician culture change was required for this transformation, and that their costs savings benefited payers – including Medicare – but the existing reimbursements system penalizes them for this, since it really creates incentives for waste by paying provider organizations more if they have higher care delivery costs due to wasteful actions.

Martha Bebinger’s “Mission Not Yet Accomplished? Massachusetts Contemplates Major Moves on Cost Containment” is a good description of the global payment proposal the state is considering. She also describes one Massachusetts health delivery system’s success, (Mt. Auburn hospital and its IPA), in working with global payment type reimbursements for about 20 years.

Harold Miller’s “From Volume to Value: Better Ways to Pay for Health Care” is a great companion to Martha Bebinger’s article because it provides a conceptual description for what Massachusetts’ global payment proposal is attempting to achieve, i.e. moving away from fee-for-service’s volume incentives to a payment system that rewards quality of care within an environment of fiscal responsibility. His Exhibit 1 illustrates how insurance risk can be separated from provider or performance risk – one of the concepts incorporated into Massachusetts’ global payment proposal. And his Exhibit 3 describes why there may be a role for continuing fee-for-service payment for certain types of low-cost, low-variability, high-social value services such as immunizations. (Overall the mechanisms for implementing global payments reminded me of a book chapter I co-authored in 1995 about bonus pools and incentive payments for physicians, “Preparing for Managed Care and Capitation,” in Alliances: Strategies for Building Integrated Delivery Systems. What has changed in the last 15 years is that quality monitoring capabilities have matured so that relevant data can be captured and analyzed quickly enough to serve as a reasonable basis for making such bonus and incentive payments.)

Forest of Trees – What Bent Cost Curves Might Look Like
While these 5 articles – and the entire issue of Health Affairs – offer great insights into health spending growth in the US, they don’t provide a broad context for what health spending growth and bending the cost curve might look like. Similarly, while the research and insights provided in the Health Affairs articles are important for health policy decision making, they may not be easily usable within the big-picture policy and political debate. In other words, these articles are describing specific trees within the healthcare cost growth forest, and what most people need is a better understanding of the entire forest.

Henry Aaron’s and Paul Ginsburg’s article comes closest to painting this overarching view of the cost growth situation and its solutions, but I was somewhat surprised that nowhere in the issue is there a simple graphic showing projected healthcare cost growth and some scenarios for literally “bending the curve.” Therefore, below are somewhat simple graphs depicting expected future spending growth and various scenarios for bending the curve of healthcare costs.

First, is a figure showing 8 different cost growth curves with the y-axis showing years
(Descriptions of each curve are below the figure)

Normal
- 7% Growth Rate (7% was chosen as a flat rate based upon the National Health Expenditure projections, which vary from about 5-7% in the coming years, but are 7.2% for years 2017 and 2018.)
Bent
- 3% Growth Rate (3% was chosen as a flat rate for what might ideally be desired based upon projections for CPI-W of 2.8% and GDP growth of 4.6-4.9% for years 2011-18.)
Invest to Bend
- 7% Growth Rate until year 4, then 3%/year
- 3% Investment Added in Years 1-4 (These investments would be expected to enable the healthcare system to operate at a 3% growth rate in later years.)
Invest to Bend & Innovate
- 7% Growth Rate until year 4, then, 3%/year
- 3% Added Years 1-2, 2% in Years 3-4, and 1% added from year 5 onward (This curve is like #3, but the investment amount is reduced to 2% in years 3-4 and then continues at 1% in all subsequent years.)
Cut & Pray
- 7% growth rate
- 5% cut first year (One-year cut that doesn’t change long term growth.)
Keep Cutting & Praying
- 7% growth rate
- 5% cut 1st year and every 5th year (This is a variant of #5 in that expenditures are cut 5% every 5 years to reduce spending.)
Invest, Then Cut
- 7% Growth Rate until year 4, then 3%/year
- 3% additional investment in years 1-4
- 5% cut in years 6, 9, 12, 15, etc.
  (This is a combination of curves #3 and #6, but the 5% reductions are every 3 years rather than every 5 years.)
Maintenance Investing and Cutting
- 7% Growth Rate until year 4, then 3%/year
- 3% additional investment in years 1 & 2
- 2% additional investment in years 3 & 4
- 1% additional investment each year after year 4
- 5% cut in years 6, 9, 12, 15, etc.
  (This is a combination of curves #4 and #6, with a early year investments in system change leading to a 3% baseline growth rate – with an additional 1% added for innovation investment – and 5% cuts every 3 years to reduce waste.)

View of the Forest Depends on the Altitude
Time-frames are an important consideration for evaluating each possible curve. For example, looking only at the first 9 years doesn’t show much difference from the 7% baseline growth rate for the various scenarios, except for immediately going to a 3% growth rate. (See figure below)

However, removing some of the options and expanding the time-frame back to 16 years, shows that three options, (between the projected 7% baseline growth rate and the unrealistic immediate shift to 3%), can achieve dramatic savings. In particular, investing in early years to create a system that can both control cost growth and eliminate waste in the long-run, (Maintenance Investing and Cutting curve scenario), brings us to a cost growth rate that approaches what might have been achieved by immediately going to a 3% growth rate. (See figure below)

Of course, the actual dollars spent is a factor of the area under the curve, so the “Maintenance Investing and Cutting” curve does represent more spending on healthcare than some other scenarios – depending upon the time-frame analyzed. However, up-front investing in health system change has already happened. The Federal stimulus bill passed earlier this year included more than $30 Billion in healthcare system changing investments, which is more than 1% of total annual healthcare spending.*

Actually Bending the Cost Curve Requires Organizational and Culture Changes
The policy and practical challenges for bending the cost curve are choosing and implementing the options that will actually change clinical and reimbursement systems that can get us to the bent curve we want. In addition, convincing the public and millions of people employed in healthcare that these changes are productive and beneficial will also be a great challenge. And meeting this challenge will require changing organizational cultures and operations, and individual attitudes and actions. Hopefully, graphs like this will help make the case that bending the curve is possible, practical, and palatable.

————–
* The American Recovery and Reinvestment Act of 2009 included $10 billion in increased funding for the NIH, $19 Billion for health information technology, $1.1 Billion for comparative effectiveness research, $500 million to train primary care clinicians, and $1 billion for several prevention and wellness programs – as well as $86 billion for expansion of Medicaid.

Encouraging Communications About Patients’ Goals

Posted on September 18, 2009 by Michael D. Miller MD

I attended a great event yesterday where experts discussed how to improve healthcare quality and safety by increasing patients’ involvement in making healthcare decisions.

This seminar, “Patient-Centeredness and Patient Safety: How Are They Interconnected,” was organized by the Kenneth B. Schwartz Center and sponsored by the Massachusetts Medical Society and CRICO/RMF. Don Berwick (President & CEO of the Institute for Healthcare Improvement) was the main speaker followed by a panel consisting of two patient safety leaders from local hospitals and a patient involved with promoting patient engagement in quality improvement.

To start the event, Dr. Berwick discussed how his thinking about healthcare quality had evolved over several decades, and his increasing belief in the importance of patient involvement. He discussed his Health Affairs article on Patient-Centered care, and summarized his current thinking about how to design patient-centered care in 8 bullets:

Place the patient at the center
Individualize
Welcome family and loved ones
Maximize health influences within care
Maximize health influences outside of care
Rely on sophisticated, disciplined evidence
Use all relevant capabilities – waste nothing
Connect helping influences with each other

Communications Is Crucial for Achieving Patient-Centerdness and Goal Sharing
The essence of the panel’s discussion was about how to improve communications among patients and their clinicians so that each others’ goals were shared and understood. One example raised by a panelist was initiatives to prevent patients from falling in the hospital. Patients may see nurses being in bathrooms with them as intrusive or uncomfortable, but discussing their shared goal of not having patients fall and hurt themselves shifts the context of the nurse’s action and enables it to be embraced by the patient rather than resisted.

From the patient’s perspective too often clinicians may have their own ideas about what the goals of the treatment should be, but without understanding the patient’s life interests and goals the two may be disconnected. For example, clinicians often ask patients what they do for work to understand if the treatment or the outcomes will be compatible with their jobs, but often patient’s happiness or life fulfillment is related to something outside of work, such as playing the piano, playing with grandchildren, rollerblading, hiking with their dogs in the mountains, or hang-gliding. Treating a patient’s injury or illness so they can do (or be able to try to do) those activities may be very different than what would be indicated if the goal was to enable them to work in an office.

Creating Policies to Promote Communications and Goal Sharing
Dr. Berwick’s presentation also included a brief discussion of how evidence based medicine (EBM) can improve patient safety by avoiding unnecessary care and setting realistic expectations about the outcomes for chosen treatments. This is captured in his 6th bullet above. One of the challenges in the current push towards more EBM – and comparative effectiveness research (CER) – is what to actually measure in this research. Combining the health system’s desire for optimal outcomes with patient-centeredness, (i.e., his 2nd bullet – “Individualize”), could be achieved by including the patient’s goals for their treatment as one of the outcomes measured in EBM and CER programs.

Benefits of Measuring Achievement of Patients’ Goals as an “Outcome”
Process measures, (such as percentage of patients who’ve received a recommended treatment), are usually easier to evaluate, but are really proxies for clinical outcomes. Actual outcomes like mortality or hospitalization can be harder to evaluate, in part because of individual patient differences and thus the raw data needs to be risk adjusted. However, measuring achievement of the patient’s goals could be very important and valuable to add to these evaluations – and could be a rough way to inherently risk adjust the data, i.e. the “goals” of treating a broken hip may be different for a 50 year old person than someone who is 70. The actual measurement of such goal achievement could be done based upon answering the question of “how well were the patient’s goals met?” Clearly this would have to be quantified in some way – and perhaps that could be done by the patients themselves on an 11 point scale from 0-100%.

Not only would measuring this “patient goal achievement” outcome add a useful dimension to some research, but it would also put the question of “what are the patient’s goals?” right at the front of the patient-clinician conversation. And in the context of health reform and system improvement, by using the dictum of, “we manage what we measure,” measuring how well delivery systems and clinicians are achieving patients’ goals could be an important force for transforming care delivery.

Bottom Line for Patients and Clinicians
The next time you’re a patient talking to a clinician, be sure to talk about your goals for treating whatever ailment caused you to see that clinician. And clinicians need to tell their patients what goals they expect to achieve from the treatment they’re recommending. This is the start of a conversation since the patient’s expectations may not be realistic – such as for a patient with a severe fracture who wants to run a marathon in three weeks. But by understanding each others goals and expectations they can agree on what should be done and how to proceed.

Need for Continuity of Care and Primary Care Clinicians
Of course some patients may seek to “doctor shop” looking for a clinician who will promise to achieve their goals. This can be good if the first clinician isn’t attuned to the patient’s wishes, but it can also be bad if the patient’s expectations are unrealistic. That is why having a trusted relationship with a primary care clinician can be so important, since their PCC can help them evaluate and digest other clinicians’ recommendations. Again, it comes down to ongoing and two-way communications to understand goals and jointly develop treatment plans and decisions.

Beyond Health Insurance Reform: Transforming Health Care Delivery

Posted on August 21, 2009 by Michael D. Miller MD

“Health insurance reform” has become the latest label for national health reform legislation, but this renaming has pushed discussion about how to transform healthcare delivery farther back into a poorly lit corner of the debate.

Transforming the delivery of healthcare can improve quality and efficiency because the current system has two fundamental impairments: 1) lack of integration and coordination among clinicians and organizations like hospitals, and 2) a shortage of primary care clinicians. There have been many proposals for how to address these structural problems, but they have tended to not be bold enough, i.e., they would take many years – and in some cases decades – to produce significant results.

Listed below are some proposals to address these problems. While all of these are reasonable as individual initiatives, because of the connection between economic incentives and other change drivers in healthcare, integrated approaches that combine multiple changes will work best.

Massachusetts Proposing to Move to ACOs
Massachusetts is considering transforming the state’s entire healthcare delivery system into Accountable Care Organizations (ACOs). These organizations would be structured to better integrate care delivery because all the clinicians and other providers would be within ACOs, (or have contractual relationships with ACOs), and ACOs would also have financial incentives to provide quality and efficiently coordinated care because they would receive risk adjusted global payments for each individual who selected the ACO. It is envisioned that shifting all reimbursement in the state to such global payments would also create incentives for the development of ACOs. The time-frame outlined for creating this ACO-global payment system is 5 years – which seems reasonable.

Medical Homes for Care Coordination
Patient Centered Medical Homes (PCMH) is a model of care delivery where each patient would have a primary care “medical home” practice that would be responsible for providing all their primary care, coordinating their non-primary care and testing, etc., and providing wellness education and self-care management. The concept for the PCMH was originally developed by 4 medical societies, (AAFP, AAP, ACOG, and ACP), and has since been endorsed by many others. The potential of receiving additional payments for providing the care coordination function inherent to a PCMH has attracted great interest from a wide variety of organizations and groups. However, without a generally agreed upon definition for a PCMH, many diluted and divergent definitions have sprung up – presumably to enable whoever developed them to qualify for more money. (I even heard 3rd hand that some pathologists were looking into how to become a medical home. I don’t know if it’s true – maybe they were just looking to understand how they could work with medical homes?)

Several states have begun demonstrations to promote medical homes, and Medicare is scheduled to start a demonstration program next January, but the regulations for implementing this program are about 8 months overdue – perhaps because they didn’t want to start something that would be dramatically altered by health reform legislation.

Medical homes would also certainly be compatible with ACOs, since ACOs would be much more expansive and larger organizations that could include multiple medical homes.

Care Coordination Demonstration Projects and Initiatives
There are many programs for increasing care coordination, from electronic medical records and HIT to facilitate the sharing of medical information, to Medicare pilots to see how case managers could help control spending in traditional (i.e. fee-for-service) Medicare. These initiatives would all be slowly or minimally effective because they are being implemented on top of the existing fee-for-service structure and non-integrated delivery systems. For example, the results of a large Medicare demonstration project showed almost no benefit from 15 different care coordination pilot sites – primarily because the nurse case managers were separate from, (i.e. not integrated into), the physician’s offices.

Similarly, the Federal stimulus bill earlier this year included significant funding for implementing electronic medical records in physicians offices. This seems like a good idea since estimates are that less than 10% of physicians offices have such systems. However, the provision was written as a percentage add-on payment to the physician’s Medicare and Medicaid reimbursements. The problem with this structure is that buying EMR systems requires a significant up front outlay of tens of thousands of dollars, and the types of physicians who have typically been paid the least, (i.e. primary care physicians), will therefore be the least able to afford these up front costs. And because they are paid the least, they will also benefit the least from the percentage add-on to their Medicare and Medicaid reimbursements. Conversely, specialists physicians – who have been paid more – will be better able to afford the up front costs of the EMR systems, and will also get the most benefit from the Medicare/Medicaid add-on. (See graph below of average physician compensation by specialty.)

I suspect the provision was structured this way because it was easy, (i.e. it wouldn’t require any additional payment structure – it would just increase the size of payments to physicians through Medicare and Medicaid), the money wouldn’t begin flowing from the Treasury until 2011, and the provision phases out the “carrot” to become a “stick,” i.e. it provides add-on payments in years 2011-14 , but these decrease each year and are replaced by payment reductions for physicians who don’t have EMR systems after 2014. (Note – only EMR systems that meet a “meaningful use” standard will qualify for the additional payments.)

Increasing the Number of Primary Care Clinicians
The American College of Physicians released a white paper in April, and Chapter 1 in the Medicare Payment Advisory Commission’s (MedPAC) June annual report to Congress both address the shortage of primary care physicians. Each of these include proposals focused primarily on using economic incentives to encourage more medical students and residents to choose to go into primary care, to require hospitals to increase the number of primary care residency slots, and to increase residents’ exposure to community based primary care settings. (An additional resource, is a new Kaiser Family Foundation web-based Issue Brief on “Primary Care Shortage”)

Some of the specific proposals from the ACP and MedPAC are:

Establish a National Health Care Workforce Policy and Commission
Increase funding for scholarships and loan repayment programs for primary care physicians
Increase residents’ formal instruction and experience in multidisciplinary teamwork, cost awareness in clinical decision making, comprehensive health information technology, and patient care in ambulatory settings to better align their training objectives and content with delivery system reform
Realign hospitals financial incentives, (both for Medicare’s educational support and for workforce supply), to increase residents’ non-hospital based experiences
Improve the quality of practice life for physicians by reducing administrative and paperwork burdens
Increase reimbursement for primary care physicians so that they are competitive with other types of medical practices. (See below for graph and additional commentary.)

(From: ACP White Paper, “Solutions to the Challenges Facing Primary Care Medicine”)

While all of these make sense, they would take many years, and even decades, to significantly shift the healthcare delivery system’s dynamics toward primary care. Therefore, below are some other ideas for increasing the supply of primary care physicians sooner:

Additional Ways to Increase Primary Care Physician Services:

Retraining Physicians. Create retraining programs for physicians who haven’t been engaged in clinical work for a while, (e.g. research or administration), or who have been doing mostly specialty care and now want to go into primary care. Some will ask why these physician would want to do this given the current compensation differences between primary care physicians and specialists? – This is why other provisions that create incentives and decrease that gap would be important. (There’s also the issue of board certification for these newly entering PCPs, but that’s a bigger discussion about the role of specialty boards, etc.)
Direct Support for EMRs. As noted above, the Federal stimulus bill provides financial incentives, (and later financial penalties), for physicians to use EMRs. A better – although more complicated approach – would be to provide grants or zero interest loans to primary care physicians. These would provide financial incentives and support to physicians who needed it the most, and provide additional support to pediatricians who generally don’t bill Medicare very much. In addition, getting more primary care clinicians equipped with EMRs would promote more integration, coordination of care, and efficiency of care delivery across the entire healthcare system, as well as highlighting the importance and prestige of primary care physicians – something that will be important for increasing their numbers in the future. (See below.)
Increasing Prestige of Primary Care. Increasing the visible prestige of primary care clinicians in the medical and general community could help encourage medical students and resident to become primary care physicians, as well providing indirect support for existing PCPs. For example, hospitals could give them preferred or valet parking, cities could give them placards for free parking at meters and city owned lots, and states could give the children of primary care clinicians free tuition at state universities. Many programs have been developed to recognize the public contribution of groups such as veterans, firemen and policemen, so perhaps some of those could be adapted to publicly recognize primary care clinicians.
Increasing Supply and Use of Hospitalists. While many specialists wouldn’t want to become primary care clinicians, there is also a need for more physicians to focus on the complex care of patients in hospitals. Turning over the care of patients in hospitals to these hospitalist physicians would also enable primary care clinicians to spend more time focusing on outpatient care. (Primary care clinicians should certainly see their patients when they are in the hospital, but the time required for managing their care – and traveling to and from the hospital multiple times a day – can certainly limit the time primary care clinicians can spend with their other patients.) This type of “specialization” would increase both the quality and efficiency of care, and could lead to physicians spending more time consulting with patients and ordering less tests and procedures. (See below for trend data in Medicare.) Of course, accomplishing this would require that these hospitalist physicians be given the ability to actively manage the patients in the hospital – something that is not allowed in some hospitals or by some primary care clinicians who insist upon maintaining full management control over “their’ patients.

(From: MedPAC June 2009 Data Book.)

Bottom Line & End Result
Shifting the ratio of primary care to specialist clinicians to be closer to 50/50 from the current ~30/70 would provide enough primary care clinicians to deliver primary care services that patients really need. This would also lessen primary care physicians’ time constraints and reduce the pressure for quickly referring patients to specialists. Overall, this would certainly be a better patient-centered healthcare environment for individuals and society. The question is, do we have to wait 20 or so years to get there – which is what it will take through graduating more primary care clinicians from school and training programs – or can steps be taken to shift the system sooner.

These types of reorganizations are not unheard of in other sectors. For example, printing companies have shifted from lead type, to offset, to laser type printing rather quickly, and telephone company employees have gone from dealing with copper wires for voice transmission, to DSL service, to fiber optic cables. These innovations didn’t wait for entire generations to graduate from school. People were retrained, and they were eager to do so because that’s where customers’ demand had shifted. If healthcare delivery can be shifted to a more integrated and coordinated system, then the incentives for providing more and better primary care will follow – and then clinicians, administrators, regulators and payers will have to pay more attention to how what they are providing, selling, regulating, and buying makes sense in a transformed delivery world.

What is Health Reform, and Why?

Posted on August 6, 2009 by Michael D. Miller MD

As Congress enters the August district work period, (the official name for the August recess), the debate about health reform has shifted from Congressional hearings and mark-ups to local Town Hall meetings, the media, (print, talk radio, talking heads on TV, and the blogo-YouTube-osphere), and the astroturf campaign styled world of organized phone banks, shout downs, and meetup/get-together rallies/service days.

Proponents and opponents on all sides are participating in and supporting all these types of activities. But the questions I keep getting are, “what is the proposal?” “What is in the President’s bill?” “What is health reform?”

Simply answered, 1) There is no single proposal – three House Committees have passed bills, (which need to be melded into one bill for consideration by the full House of Representatives in the fall), and one Senate Committee has passed a bill and another is still trying to cobble together a bipartisan bill; 2) The President has 3-4 principles, but doesn’t have his own “bill”; and 3) That is still being determined – but if you listen to the escalating frenzy, (which is why I frequently wear earbuds that may or may not be connected to an MP3 player), health reform is all about a public insurance plan option.

Health Reform Centering on a Public Plan Option
So why is the debate focusing on a public plan option? Probably because it serves as a fulcrum for many of the hot button sound-bites on both sides:

A public plan option is necessary to create competition in the insurance marketplace
A public plan option is necessary to provide competition to private health insurance
A public plan will keep the private insurance companies “honest” by creating a competing organization that won’t be concerned about profits
A public plan is the first step to achieving a single-payer health system
A public plan is a government take-over of the healthcare system
A public plan is socialism
A public plan is the first step to a college football Bowl Championship playoff system – OK nobody has said that…. yet

What is a Public Plan, and Why?
As I’ve written in the past, there has been many descriptions of what a public plan could be – ranging from the Federal Employees’ Health Benefits Program (FEHBP) to traditional Medicare – and yes, Medicare is a government program despite some media reports of individuals telling Members of Congress to “keep the government out of Medicare.”

Obviously the structure of a public insurance plan would determine its affects on the US healthcare system. While analyses of all possible public plan options haven’t been conducted, a few have looked at how much could be saved and how many people might enroll in a public plan that looks something like Medicare – but paid higher rates to doctors and hospitals, and was run more flexibly than traditional Medicare.

John Sheils at the Lewin Group released a report analyzing this type of public plan option, and a more recent report from the Urban Institute expands on that work and makes the case that this type of public plan option is needed to increase competition in the health insurance marketplace because there has been significant consolidation in recent years. The Urban Institute’s paper makes some compelling arguments, but its analysis also combines creating a public plan option with national insurance reforms, (i.e. replacing state based insurance regulation), and national or regional health insurance exchanges. Since each of these three initiatives, (public plan, national regulation, and an exchange), would change the competitive landscape of the health insurance market, it would be helpful to have analyses examining each of these ideas alone and in different combinations. [Note - the Urban Institute released a report in April about Health Insurance Exchanges, which discussed how exchanges can increase competition and consumer options by reorganizing the market for health insurance.]

An informative real-world initiative about what the combination of insurance regulation and a health insurance exchange can accomplish has occurred in Massachusetts. With insurance regulation historically being the responsibility of the states, Massachusetts has had rather stringent regulations, (for example, see this chart from the Georgetown University Health Policy Institute), which is why none of the media stories about individuals being denied coverage by their insurer for apparently necessary care have come out of Massachusetts. On top of this strong regulatory environment, in 2006, the state created the Commonwealth Connector exchange to make 3 levels of insurance packages from several insurance companies available to individuals and small companies across the state.

Has this increased competition, transparency, and the ability of individuals to compare plan options? Yes, yes, and yes. Has it controlled the growth in health insurance costs? Maybe a bit – but not enough because insurance costs reflect the underlying cost of care people are getting, and insurance regulation and an exchange alone aren’t going to “bend the curve” in healthcare costs. So it could be argued that the purpose of a public plan option is cost containment, and the Urban Institute’s analysis concludes that there would be system-wide savings from the public plan option. However, these savings are based on the public plan paying lower rates to doctors and hospitals, and thus competitively driving down all prices and costs – rather than any br0ader healthcare delivery reforms resulting in improved quality and efficiency.

Answering the Question
So while health reform options have been debated and analyzed, there still seems to be many questions about what health reform will be when Congress finally comes to some semi-consensus around one bill in October, November or December. What is clear, is that whatever this is, it will be called “health reform.”

But beyond what is in that bill there is a lot more that should be considered “health reform.” Specifically, earlier this year, Congress allocated $1.1 billion for comparative effectiveness research, $10 billion more for NIH research, about $30 billion for implementing health information technology, expanded SCHIP (an existing public insurance program run by the states) to cover an additional 3 million children, empowered the FDA to regulate tobacco, and are examining ways to improve food safety and other initiatives outside of the “health reform” bill to improve the health and well-being of Americans – both through targeted legislation and changes to regulations and government operations.

So what is health reform? It’s going on all the time in many places and ways. Some of it is happening at the state and local levels, some of it is happening at the Federal level, some of it is happening in the private market, (with large employers working together to improve the healthcare they are buying), and some of it is happening within health delivery systems that are working with organizations like the Institute for Healthcare Improvement to improve quality and reduce costs.

While the focus has been on doing “health reform” this year, the reality is that we will have to keep “doing” health reform for many years to really make significant improvements. This process of health reform is like making a good red wine: It takes several years after the vines are planted before they bear fruit – and they must be regularly fertilized and tended to. It then takes several more years before the harvest is good. And making the wine requires that the grape squeezings ferment to produce the beginning of the wine which then must age to make a really quality product.

Easy? No.
Time consuming? Yes.
Worth the time and effort? Yes.
What’s the alternative? Whining about why “health reform” hasn’t happened.

Real Health Reform in Massachusetts

Posted on July 29, 2009 by Michael D. Miller MD

The Massachusetts Special Commission on Payment Reform recently issued its recommendations for shifting the state’s health care system from Fee-For-Service (FFS) to Global Payments over a 5 year period. The Special Commission’s report lays out a good case for making this change, describing why it needs to be adopted by all payers, (although each payer would still pay different rates, they would all use the same fundamental global payment structure), and some of the challenges for successfully navigating a 5 year transition period from the current mostly FFS system to one dominated by global payments.

The report summarizes its recommendations into 9 areas:

The development of Accountable Care Organizations (ACOs). (Health delivery entities that can work as a team to manage the provision and coordination of care so that they are accepting responsibility for all – or most – of the care for their enrollees.)
Patient choice. Patients will be able to choose their primary care physician, and will not be restricted to only clinicians in their ACO – but may have to pay more for services outside of their ACO.
Patient-centered care and a strong focus on primary care. Each patient’s selection of a primary care provider will direct their insurer’s payments to their ACO, which will receive technical support to help develop/create medical homes.
Widespread adoption of the medical home model. (The Special Commission concluded that “medical homes overlaid on the current FFS system cannot achieve its vision for a high-value health care system.”)
Pay-for-performance (P4P) incentives to ensure appropriate access to care, and encourage quality improvement, evidence-based care, and coordination of care.
Sharing of financial risk between ACOs and insurers. ACOs will be held responsible for performance risk—including cost performance and meeting access and quality standards. Insurance companies, (and self-insured companies), will retain the insurance risk for the insurance contracts written to groups and individuals.
Strong and consistent risk adjustment. Global payments will be adjusted to reflect providers’ clinical and socioeconomic case mix, and, as appropriate, geography, so that ACOs will not be financially harmed by accepting high-risk patients with complex or chronic health care needs.
Cost and quality transparency. ACOs will report performance against common metrics measuring health care quality and access to appropriate care.
Participation by both private and public payers to ensure consistent alignment of care delivery incentives and to minimize administrative complexity and costs.

These changes would have tremendous implications for improving quality and controlling costs, and be much more significant than the coverage expansion the state started in 2006 – which could be viewed as the first part of health reform in Massachusetts, with the movement to global payments as the second part. Specifically, the Special Commission’s recommendations could largely accomplish the somewhat wonkishly termed goal of “bending the curve” in health costs that is being bantered about in DC these days. These changes would achieve that aim by shifting the financial incentives for clinicians and provider organizations from providing more care, to providing higher quality and more cost effective care – which should include more preventive services and interventions.

Incentives Need to Be Translated to Small Groups
However, those goals will only be achieved if the incentives created at the ACO level by global payments and P4P are translated to much smaller groups of clinicians and others within each ACO. If clinicians are still compensated based upon a modified FFS system within the ACOs, then their incentives will still be mostly for volume over quality. Similarly, if they are told that their compensation will be based upon the overall performance of the ACO, then they won’t feel that their actions will be significant enough to effect the ACO’s or their own financial success or failure. (This is the reason why Medicare’s Sustainable Growth Rate formula hasn’t constrained the growth in Medicare’s spending for physician services, i.e. why would physicians feel that their individual actions matter when they are pooled in with hundreds of thousands of other physicians across the country?) In contrast, if the incentives and data monitoring are done at the level of the individual clinician, (or small clinical entity), then each individual can understand how that their actions will influence their own success or failure.

Just as creating granular incentives depends upon monitoring the clinical decisions and activities at the same level, there is also a need to monitor the overall operations and quality performance of the ACOs to be able to adjust global payment amounts and methodologies. This is why analyzing data to support individual and ACO decisions, and monitoring the success of movement toward global payments, are two of the major functions (see #3 & #5 below) for the entity the Special Commission recommends be empowered to oversee the transition to global payments across the state.

Special Commission’s Recommended Functions for Transition Oversight Entity:

Establish the methodology for global payments
Establish the parameters defining an ACO
Analyze health system data to support providers, patients, and employers in making coverage and care choices
Recommend the necessary infrastructure support for providers
Establish transition milestones and monitor progress towards those goals
Identify and implement mid-course adjustments as needed

Implications for National Actions and Health Reform Advocates
Up here in my area of neon-blue Massachusetts, the focus has been on how it is essential to have a “strong public plan option” because that will lead to a single payer system. Many community activists have held onto this position despite Massachusetts making significant improvements in coverage without a public plan option, (or single payer), but if the state of Massachusetts can implement the Special Commission’s recommendations for an all-payer global payment system in ways that transform healthcare delivery, it will be the most significant health reform initiative in the United States since the creation of Medicare and Medicaid in 1965.

Yes, that’s my opinion, but I can defend it for several reasons. First, implementing an all-payer global payment system really can’t be watered down too much. Certainly, for example, the large teaching hospitals – which the report indicates are doing financially better than community hospitals – may continue to do better under a global payment system, but fundamentally global payments, (with associated incentives for quality), will transform FFS incentives for volume of care into incentives for efficiency and quality.

And second, shifting the healthcare delivery system’s fuel source from FFS to global payments should cause clinicians and health providing institutions and organizations to reorganize themselves into forms, (i.e. ACOs and their subsiadary building blocks), that can accept global payments and effectively manage care. (If they don’t then they will likely find that their global payments aren’t covering their costs, or their quality of care falls behind those who do effectively reorganize their care delivery structures and incentives.)

The Commission uses the term Accountable Care Organizations (ACOs) to describe these types of conglomerations, but each ACO will certainly have its own unique structure derived from the components that were woven together to form it. (I like to call these Multiform Accountable Care Organizations or MACOs.)

While health reform is often talked about as if it would create the same structures and options across the country, this variety will be good a thing since it will reflect local cultures, as well as the unique characteristics of the local providers, clinicians, payers, and community leaders, and their relationships.

While Massachusetts has been pointed to as a model for national health reform – and the state should be proud of achieving near universal coverage – shifting the health system’s fuel source from volume to quality will be a much more profound achievement with longer lasting implications. After taking significant steps to increase insurance coverage to >97%, payment reform and delivery system transformation are the next logical tandem steps. Nothing else being discussed at the Federal level or in other states would have as sweeping an impact as going to an all-payer global payment system. (Yes, there are Federal and state demonstrations and pilot programs for medical homes and other more focused types of bundled payments, but they are toe-dipping rather than diving-in initiatives.)

Next Steps
The state legislature is expected to start hearings on the Special Commission’s recommendations in September. At this point the major stakeholders – including insurers, doctors, and hospitals – are supporting the recommendations. Health reform advocates should start paying attention and figuring out how to mobilize support for the legislature to implement these recommendations so that no matter what happens with Federal reform, Massachusetts will be ahead of the curve in taking real steps to bend the spending growth curve. And if there is no Federal legislation this year, Massachusetts will be even farther ahead of the curve and positioned to lead the rest of the nation as well as create a more economically attractive environment for starting businesses and creating jobs – while improving the quality of healthcare.

Making Health Reform’s Parts Work Together – Keeping It From Jamming

Posted on July 22, 2009 by Michael D. Miller MD

As health reform legislation moves forward, (having been passed by one of the two Senate Committees and two of the three House Committees last week), the tension between policy and politics is increasing. This political process can make it hard to maintain the practical functionality of the legislation, i.e. not sacrificing the substantive policy goals to the political realities.

One of the great challenges in making these trade-offs is to retaining reasonable functional relationships among the many necessary financing and delivery system changes to actually improve the healthcare system.

Keeping the Implementation of Health Reform from Getting Jammed Up
An analogy for this challenge came to mind when I was in DC last week. At a friend’s house, I was fixing a lock on one of their bathroom doors – the door’s latch wouldn’t catch in the door jam because the strike plate had been improperly aligned.

The options for this situation are:

Doing nothing – leaving the door so it doesn’t latch or lock.
Removing the strike plate and expanding the hole in the wood of the door jam. This would enable the door to latch, but also would have worn out the wood of the door jam, and made it so the door could be locked from the outside because the latch wouldn’t be compressed enough against the jam to unlock the door as it was being closed.
Moving the strike plate. But this would require chiseling out wood from the door jam, drilling new holes, and then repainting the door jam.
Moving the latch and locking mechanism on the door. But this would have required cutting into the door, making new holes, filling the old holes and spaces, and repainting the door.
Enlarging the height of the hole in the metal strike plate so that the latch catches.
Enlarging the height of the hole in the metal strike plate and the door jam so that the latch catches, AND the latch deploys outward enough so that door’s locking mechanism can be activated from the inside, but the strike plate is close enough to the edge of the door so that the door can’t be locked from the outside.

Clearly these different options vary in how much effort, time, and resources they require, and how well they improve the situation. (I went with #6 for my friend’s door.) Similarly, in health reform, how the different parts of the legislation interact and how many resources they require for implementation are important considerations.

As I’ve written before, healthcare delivery and financing are closely interconnected, and making changes in one can have profound effects on the other. Therefore, as health reform legislation is shaped to accommodate political considerations – such as support for access to care in rural areas, financing without unacceptable tax changes, mandates to achieve near universal coverage paired with insurance market reforms, and promotion of certain technologies and preventive interventions – it will be a tremendous challenge to make sure that the moving parts of the financial systems latch correctly with the delivery system’s strike points in ways that promote better efficiency, quality and access. An additional challenge will be for the legislation to provide enough time and resources for each of the changes so that they don’t get jammed up in their real world implementation.

Diabetes Updates – New Diagnostics, Increasing Rates, and Implications for Health Reform, CER, etc.

Posted on June 17, 2009 by Michael D. Miller MD

Changes in the diagnosis and treatment of diabetes is a great example for understanding how healthcare delivery constantly evolves based upon new discoveries. And the history of these changes may help illuminate some thinking about health reform and the development and use of comparative effectiveness research (CER).

First, a little background on diabetes.

Diabetes Background
Diabetes mellitus (or “sugar diabetes”) occurs when the body has problems regulating the level of sugar (specifically glucose) in the blood. This can be because the body’s pancreas doesn’t produce enough insulin, or for some reason the person’s organs become resistant to the actions of the insulin that is present – or sometimes both occur simultaneously. Impaired control of glucose means that the levels get too high, which produces problems in the eyes, (leading to blindness), in the kidney, (leading to kidney failure), and in the small blood vessels elsewhere in the body, which can lead to nerve damage and low oxygen delivery to the extremities – particularly the legs and feet, (leading to amputations).

In olden times, diabetes could be diagnosed by sugar in the urine. (Medical lore says this was done by taste….) However, until insulin was discovered in 1921 there were no therapies for severe insulin deficiency. And even once insulin became available, sugar in the urine was still the way diabetes was diagnosed and monitored – usually with a dipstick that changed color depending on the sugar concentration.

It wasn’t until the 1960s that measuring blood glucose levels became possible – and only then in the doctors’ offices because the machines were large and expensive. In the 1980s machines small and cheap enough for patients to monitor their blood sugar levels at home became available. This enabled patients to start adjusting their own insulin dosages based upon their blood sugar levels. (Before this it was too dangerous for patients to significantly alter their insulin dosages because while too little insulin leads to too high sugar levels causing long-term damage, too much insulin can drop sugar levels too low and lead to confusion, coma and death.)

In more recent years it was discovered that keeping diabetics’ sugar levels near normal could prevent essentially all the adverse consequences of diabetes, i.e. blindness, renal failure and amputations. But doing this based upon finger-stick blood sugar levels even 3 and 4 times a day was tricky – and those were just single data points. So in the mid 1970s it was proposed that monitoring the amount of hemoglobin in the blood that had combined with glucose would give a measure of the average blood sugar level for the 2-3 month life of the red blood cells. (It was known that glucose irreversibly connects to the hemoglobin in red blood cells in a way that directly correlates to the blood sugar level.) This test, known as “glycosylated hemoglobin, (or HbA1C, or simply A1C), has been increasingly used over the past few decades to monitor diabetics and adjust their treatments, with the goal to keep A1C levels below 7%, since the level in people without diabetes is 4-6%.

Care Lags Discovery and Development of Innovations
Despite improved ability to monitor diabetes, it is still under diagnosed, and poorly managed. It is estimated that there are about 6 million people in the US who have diabetes, but don’t know it – which is about 25% of all people with diabetes. And in 2003-2004, only about 57% of people with diabetes had A1C levels <7%. (The medical and lost productivity costs for all people with diabetes may be approaching $200 Billion.)

And the prevalence of diabetes is increasing – and with it so are the costs of treating people with diabetes. Last year I wrote about this, and now the CDC has updated information showing the continuing growth in the number of people in the US diagnosed with diabetes:

Source: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm

The treatment of diabetes has also changed. After insulin was discovered, different forms and modifications where developed to change how quickly it acted, and beef and pork sources have been replaced with biotech “human” insulins grown in bacterial cultures. Many different types of non-insulin treatments for diabetes have also been developed – these act primarily by increasing insulin production from the pancreas or the action of the insulin in the body.

Which brings us back to the A1C test. An International Expert Committee from the American Diabetes Association is now recommending that the A1C test be used to diagnose diabetes. This would replace (or supplement) the traditional fasting blood glucose diagnostic test, and the A1C test would still be used for twice yearly monitoring of the adequacy of treatment for people with diabetes.

These developments in diagnosis and treatment have progressed in tandem – each leveraging off the knowledge gained from the other – with the A1C test being part of the continuing evolution of tests for diagnosing diabetes. For example, the fasting blood glucose level for diagnosing diabetes has changed over the years. It was originally set at 140mg/dl in 1979, and then lowered to126 in 1997, when it was also decided that a level between 110-126 should be considered pre-diabetic, or “impaired fasting glucose.” And in 2003 the lower bound for “prediabetes” was lowered to 100.

Why A1C Now?
While A1C testing has been used for years, there have been problems in standardizing the measurement. (This is discussed in the ADA paper linked to above.) But now A1C measurement inconsistencies, (which occur for all lab tests), have been narrowed sufficiently so that the ADA committee is recommending that an A1C level of >6.5% be used to diagnose diabetes, (for patients who are not pregnant and do not have hemoglobin abnormalities – these can change HbA1C levels significantly), and that people with A1C levels >6.0% and <6.5% be considered to have “subdiabetic hyperglycemia” because they have a significant risk of progressing to diabetes.

So Back to Health Reform and CER – The Challenges Ahead
The challenges ahead are to make sure that we continue to utilize future discoveries in a timely and intelligent way. Which finally brings us to health reform and CER. Health reform that expands insurance coverage should dramatically improve the diagnosis and treatment of people with diabetes – which should also help control other healthcare and societal costs because poorly controlled diabetes leads to many other costly problems. However, immediate cost pressures present barriers to using the best diagnostic and therapeutic interventions.

Comparative effectiveness research is supposed to provide information about the best interventions, but as has been seen with advancements in diabetes, what is best often changes in progressive leaps based upon new discoveries. And one of the limitations of CER, (and all research for that matter), is that it takes time to do the work and analyze the results. Therefore, research really provides information about what was the best when the research started – which could have been several years before the results are known and disseminated. And this time lag effect can be even longer when the research is based upon previously published studies or analyses of clinical records.

The lesson here is that while CER and similar research can provide very important and useful information, it must be put into the proper historical and clinical contexts. What was state-of-the-art when the research protocols were developed may be 2, 3, 4 or more years out of date when the data is analyzed. This reality needs to be considered when such information is used for coverage and reimbursement, and decisions about health delivery and financing system redesign.

I am confident that most insurers are not paying for A1C tests to screen people for diabetes – and that it will likely take a year or more for even the most progressive insurers to do so…. but they eventually will. Which raises the question, what did they gain by waiting? And what did they, (and the patients), lose?

Addendum: The hospital lab my doctor uses charges $59 for a HbA1C test. So assuming that price doesn’t come down if more people are getting the test, the calculation needs to be made as to what is the ROI for using HbA1C as a screening test? And the CER questions are how to identify people who would most likely benefit from HbA1C screening, and how to determine how frequently the screening should be done?

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