Improving Cancer Care in Medicare

Posted on May 5, 2009 by Michael D. Miller MD

This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA). The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature. This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited. That is, under current law, for non-cancer illnesses, Medicare Part D plans can still limit coverage to only the off-label uses listed in the standard compendia.

American Medical News ReachMD Interview May 5, 2009:
Off Label Coverage by Medicare Part D Plans

I had recommended that the MIPAA change go beyond cancer to include serious or life-threatening conditions – terminology that is somewhat imprecise, but widely recognized, including by the FDA. However, I suspect that because of cost concerns, this broader expansion of off-label coverage was not included in MIPPA. I find this interesting for two reasons. First, in these times of record government spending, even MIPPA’s limited coverage expansion for off-label cancer treatments raised some concerns about cost increases – which I wrote about in January. And second, that restricting coverage of treatments in this way seems philosophically opposite to the intended benefits of Comparative Effectiveness Research – which is all about using the best research findings to improve the quality of care. Of course, with the size of our health care system, I’m sure this won’t be the last time the left and right hands are not perfectly in sync.

Business Perspectives on Comparative Effectiveness Research

Posted on May 2, 2009 by Michael D. Miller MD

Comparative effectiveness research continues to be a hot health policy issue for many companies and stakeholders, in part, because they’re concerned that CER information will be used to deny access to innovations because of cost.

I recently talked with Jeff Sandman, CEO of Hyde Park Communications, about how healthcare companies should productively approach CER issues, and how quickly CER would lead to dramatic changes in the healthcare system. (See part of our conversation below.)

There will certainly be more reports, seminars, meetings and Congressional hearings about CER as the $1.1 Billion in ARRA funding for CER is distributed, and the results of that research begins to roll in. I’ve written about CER in the past, (see here and here), and expect to continue writing and talking about it in the future – and I would be very interested to hear anyone else’s perspectives on this issue and how they think it will impact the transformation of healthcare.

Investment for Health Reform – Escaping the Valley of Death

Posted on April 30, 2009 by Michael D. Miller MD

The debate about health reform has mostly focused on expanding insurance coverage and controlling costs. However, successfully improving the US healthcare system will require some long-term quality improving investments.

The stimulus bill (ARRA) included two such investments. The $1.1 Billion for Comparative Effectiveness Research has been widely discussed because it is important, and a very large percentage increase in the Federal Government’s spending in this area. But the ARRA bill also included $10 Billion to increase NIH’s funding.

The significance of the increased NIH funding is twofold: First, it will provide expansion of biomedical research related jobs. And second, it will help the NIH increase the work it does in translational research, which should help biomedical research build a better bridge over what the Parkinson’s Action Network and others have labelled the “Valley of Death.”

Valley of Death
The Valley of Death, as described by PAN at a briefing last week hosted by FasterCures, is the work required to turn basic lab research discoveries into treatments that help people. Some people call this “translational research,” and the NIH has been moving in this direction by funding institutional centers with Clinical and Translational Science Awards (CTSAs). The two major activities that occur (or don’t occur readily enough), in the Valley of Death are prototype discovery and design, and preclinical development. (See PAN’s graphic below.)

The Valley of Death is a real challenge because while these activities are vitally important for improving the quality of healthcare over the long run, the incentives for doing this work are smaller than for basic or fully applied research: In the private sector, there may be small incentives for translational work, but in academia the incentives may actually be negative because successes in this area garner little or no professional prestige or recognition, and more importantly, generally doesn’t attract research grants, i.e. money to support the researcher’s lab and the university.

A Bridge to Better Care
Filling in – or bridging - the Valley of Death, (feel free to pick your metaphor), is important for improving healthcare because there are so many serious conditions where current treatments are very inadequate. For example, Parkinson’s is one of many neurodegenerative diseases where existing treatments address some of the symptoms – and often only partially or temporarily – without effecting the course of the illness. Similarly, while significant advances have been made in treating cancer, those successes have been in select types of cancer, (with leukemia being one good example), or have made the treatments much easier for the patient. Both of these are valuable, but it is also worth noting the recent article discussing how survival rates for cancer haven’t really increased over the last several decades.

The cure for this problem is clearly more (and better) research and development…. and the translational work that bridges the two. (Perhaps we should talk more about increasing R&T&D, rather than just R&D?) PAN’s description of how to do this is sophisticated and multifaceted. As their illustration below shows, not only are the NIH’s CTSAs and SBIR programs important for helping institutions and individual researchers push forward with more translational work, but other parts of the solution include DoD’s Telemedicine & Advanced Technology Research Center, and private foundations and venture philanthropy.

Increasing funding for translational work through all these sources may help build a bridge, (of fill in the Valley), but translational work will also benefit by greater coordination of efforts. At the institutional level that is part of the role of the CTSA’s, but there could also be more coordination and emphasis of translational work at the NIH itself – which is why PAN is recommending the NIH conduct an analysis and present their own recommendations for improving the translational activities of NIH funded research programs.

Institutional researchers could also benefit by having more resources about the nuts and bolts of translational work – like how to structure research and information so that it will be readily usable for filing an IND with the FDA. Universities already have Technology Transfer/Licensing offices that serve the dual function of licensing university generated research to private companies for commercialization and ensuring that the university receives fair compensation for the company’s use of these discoveries – which is required by the Federal Bayh-Dole Act. Perhaps universities should also have offices that work to educate their researchers about translational activities to help them plan their research so that the information they generate will be more readily usable by those farther down the development pipeline?

This is clearly not an easy nor readily obvious task. At the FasterCures/PAN briefing last week, someone told a story about an academic researcher who experienced a 2 year delay in moving their discovery along the development pathway because they didn’t understand the information that would be needed.

Rather than make specific recommendations about how to improve the situation for basic researchers, I’ll just note that the Bayh-Dole Act managed to get every institution receiving Federal grants to create a Technology Transfer/Licensing office. It seems that every institution could also have a Office of Translational Research Assistance too. How to structure the funding or financial incentives for this could be complicated, but certainly not impossible. And given that we are spending tens of Billions of tax dollars on biomedical research, we should also be doing everything we can to make sure that the discoveries coming out of that research gets translated into better treatments for patients ASAP. Delays because academic researchers don’t want to pitch their careers into the Valley of Death, shouldn’t be a tolerated part of the structure of our biomedical research system – which, as I’ve previously discussed, is one of the four spheres comprising our entire healthcare system.

Comparative Effectiveness, Efficacy, Evidence Based Medicine, P4P, etc…

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

Comparative Effectiveness Research (CER) is being talked about more and more as a fulcrum for controlling healthcare costs. For example:

The Congressional Budget Office issued a report on CER in December 2007 and has highlighted it in more recent analyses and reports about health reform options
The ARRA legislation included $1.1 Billion for CER
ARRA included language for the IOM Committee on Comparative Effectiveness Research Priorities to provide a report by June 30, 2009 about how to spend the $400 million allocated to HHS for CER.

All this discussion has kept me thinking about how CER will be done, how the results from this research will actually be used to improve quality and reduce costs, and what are the scope of healthcare issues that CER is, will, or should be applied to help improving.

While understanding what works best in healthcare is certainly a worthy goal, this is far from a simple task. Some of the factors that complicate research to compare the effectiveness of various treatment options are:

Gold-standard double-blinded trials for clinical research provide information about efficacy – which is different than effectiveness.
Observational research can provide information about real world effectiveness, but the information from this type of research can be flawed by problems in the data – including selection biases and other conclusion skewing factors.
Both these types of research methodologies inherently have a lag between the time the research project starts and the time the data is analyzed and conclusions developed. This time lag is often several years, during which new treatment options will likely have been developed. Thus, CER really is only answering questions about the most effective treatment options when the study began, not when its conclusions are presented.
There is also considerable controversy about what factors to compare in CER projects. That is, should only clinical outcomes be compared, or should costs be a factor? And if cost is a factor, how are indirect costs, such as diagnostic testing, office visits, patient’s time, etc., included? And how is quality of life valued? (Some CER analyses report results according to Quality Adjusted Life Years).
And of course people interested in biopharma and medical device innovations are concerned that CER will be used not just to inform clinicians and patients, but to justify coverage and payment decisions which will impact R&D in therapeutic areas where reimbursement for innovative products is denied or limited.

All of these factors point towards larger issues of how to ensure that medical practice is maximizing knowledge to optimize clinical care for the good of the patient and society. In some cases, this is termed Evidence Based Medicine (EBM). In theory CER should support good EBM ASAP. And from what President Obama has said, he wants this done PDQ.

Health System CER & Evidence-Based Interventions
While all these challenges for CER are ongoing, there also seems to be opportunities for applying the principles of CER and EBM to more system wide properties of the US healthcare system to increase value and efficiency. For example – and I hope I’m not beating a too tired horse here – but the surgical checklist (and similar quality improving activities) have been shown to increase quality and reduce costly events, but not all hospitals and clinicians are using them. Therefore, how about research to compare the effectiveness of hospitals (or surgeons, etc.) that use and don’t use such practices? Some people might say that we don’t need this research since the value of these practices is already known, but perhaps focused research highlighting this information will serve as a big push to get the laggards on-board.

Similarly, CER type analyses could be applied to Medical Homes to determine what characteristics and capabilities of Medical Home medical practices make them better at improving the quality of patient care and controlling overall spending. In particular, there might be specific features of Medical Homes that would be most important for diabetics, and others for patients with CHF, etc. And currently NCQA’s 3 tiers of Medical Homes build upon each other, but don’t permit greater granularity nor do they distinguish between potentail patient populations. This research might be complicated, but with initiatives such as Medical Homes being proposed as a way to redesign and reconfigure outpatient care in the United States, more focused research beyond the existing and planned demonstrations and pilot projects might be very worthwhile expenditures.

P4P for Cost Containment
Another big push for cost containment in health reform is pay-for-performance (a.k.a. P4P). While the knowledge gained from CER could certainly be fed into P4P practices, P4P itself has some controversy about how well it does or does not work to change behaviors to improve quality and reduce costs. At a breakout session about P4P at a conference on Friday led by Bob Galvin, MD (GE’s Director of Global Healthcare), I stated that two basic criteria that P4P interventions need to be successful are:

The group effected needs to be small enough that each individual feels that changing their actions will effect their compensation, i.e., a group of 500 clinicians is too large, but it most likely can be larger than 5.
The information about how the group or the individual is doing towards any P4P goals is delivered often enough to provide timely feedback, i.e. once a year is not frequent enough, perhaps quarterly is OK, and monthly would be great.

Dr. Galvin pointed out that the size of the P4P incentives also needs to be significant, i.e. it can’t max out at $100 per clinician. And another participant noted that the P4P measures need to be controllable in some way by the clinician. For example, while patients’ seat belt use might be somewhat influenced by clinicians’ reminders and admonishments, clinicians are much more able to see that their diabetic patients are getting regular HbA1C testing, eye exams, and appropriate immunizations.

Coming Full Circle From CER to P4P
18 years ago I coauthored a book chapter about the structure of bonus pools and other P4P-type incentives for physicians in nascent managed care organizations. Unfortunately, in the early 1990s, there weren’t robust information systems to provide data about “performance” for these P4P systems to be effectively implemented. Perhaps now – and in the future – as health IT matures and become well integrated into healthcare delivery, better data will be available and P4P can be productive for clinicians, patients and society.

To help make that potential a more likely reality, perhaps some of the CER efforts could also be directed toward determining how to best structure and implement P4P programs to maximally change clinician (and possibly patient) behaviors to better utilize information about what is already known to work best in medical care. And then these same P4P interventions would be in place and prepared to use the new knowledge that will come out of the expanded CER programs starting this year – and which will hopefully enable us to dramatically improve medical care and the medical system in the future.

Quality, Checklists, Patient Education, the TV Show ER, and Comparative Effectiveness

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

In case you missed it last week, amidst all the returning stars for one of the final episodes of the TV show ER, there was a dramatic Operating Room scene where Dr. Benton (played by Eric Lasalle) is “observing” the kidney transplant of Dr. John Carter (played by Noah Wyle), because as we see, the transplant surgeon is a very coarse and roughshod individual. The significance of the scene is that as the surgery is about to begin, Dr. Benton pulls out his pre-surgical checklist and browbeats the transplant surgeon into going through it – during which the nurses note their concern that they don’t have reperfusion solution in the OR, so they go and get some as the surgery starts. Since this is TV, this turns out to be crucial when the kidney develops a clot, and a delay in getting the solution could have meant the difference between success and failure of the kidney transplant. (Note – this connection may be taking a bit of artistic/entertainment license, but the point is that delays in having needed equipment or supplies can effect the quality of care.)

While Atul Gawande has written about such checklists in the New Yorker magazine, perhaps this fictional medical TV drama will help more people understand the importance of such quality improving steps, and even encourage them to start asking their doctors and hospitals if they use these types of quality improving checklists….. And if not, why not?

Physicians’ Perspectives
The next day I was talking with a physician friend, and mentioned the episode. I was both bemused and concerned that he said all the staff is his outpatient clinic were talking about the returning stars, and nobody had mentioned the checklist scene. We then talked about how physicians often think the way they do things is the best, yet generally lack any data to show how well they are really doing. We agreed that physicians have traditionally viewed checklist etc, as “cookbook” medicine that took away their autonomy. I pointed out that while this might be true on a very microscopic level, by systematizing what they routinely do in a way that improves outcomes, they can then focus their knowledge and skill onto the unique aspects of each patient’s needs.

This is similar to what a basic science researcher once told me about golf. (He is a near scratch golfer.) He told me that since the game has so many variables, more of them that you can eliminate the better you will perform. For example, always playing with the same clubs is obvious, but for the same reason you should also play with the same brand and type of ball and glove, and develop standard pregame and preshot routines. That way, you can focus on the variables you can’t control, such as the weather, the wind, the lie of the ball, etc. The same is true for clinical care. By standardizing the routine and repetitive actions according to protocols that have been shown to work well, clinicians can focus on what is variable and important. (This is also why I always keep the same set of things in one pocket: keys, chapstick, two blue pens, one red pen, and my migraine medicine. And why I always leave my keys, wallet, sunglasses, etc. at same place at home. That way I never have to spend time looking for things I use all the time.)

Collecting and analyzing data about individual physician performance is really going to be the next significant development in health reform and quality improvement. And it is already occurring in some places – such as within the health benefits program for Massachusetts government employees.

This data collection, analysis and reporting will be similar to what is being done for hospitals, and thus will follow the trend of taking technologies out of the hospital and using them in the outpatient world. However, as with all healthcare data analysis. the major challenge will be in adequately adjusting for patient differences so that physician performance is based upon realistically achievable outcomes rather than the severity of the patient’s underlying illnesses. (The limits of such risk adjustment have hindered the usefulness of hospital quality data reporting.)

Comparative Effectiveness
The recent stimulus legislation included $1.1 billion for comparative effectiveness research. Greater federal funding in this area has raised concerns among some people in the medical research industry because this research could focus on comparing one medicine to another, or a medicine to a device, etc. without adequate risk adjustment in the research – and then be used by insurance companies and government agencies to make coverage and payment decisions. And these concerns are legitimate because using such analysis and research for coverage decisions about medicines and devices has been done in countries such as England and Australia.

However, there is also an opportunity for comparative effectiveness research to be used to improve actual clinical practices by developing a broader array of checklists and other standardized protocols. This is part of the promise of electronic medical records, since they can easliy incorporate such standardized guidelines into their formatting. But from what I can tell, each brand and type of EMR/EHR has different standardizations and guidelines, and the way they display them can cause clinicians to quickly suffer from “alert fatigue,” so that eventually clinicians ignore all the suggestions and warnings – making them worse then nothing.

Aside from the technical issues of EMRs, the systemic challenge for successfully using comparative effectiveness to improve clinical care in this way is overcoming the resistance and fear of physicians. This factor almost ended the existence of the federal Agency for Healthcare Quality and Research, because its first major project, (when it was called the Agency for Health Care Policy and Research), found that surgery for low back pain was generally not indicated. This conclusion caused such a reaction in the medical community that Congress almost stopped funding the entire agency.

Conclusions

Innovations that are being used in hospitals will be increasingly used in outpatient clinics and private practices.
These innovations will not only be technologies, such as diagnostic tests, but also methods of care, such as standardized checklists and protocols.
Using comparative effectiveness research to develop and validate the ability of such standardization to improve outcomes, will have greater effects on increasing quality of care and controlling costs than will research comparing different treatment options for individual diseases – even for very common and costly conditions like diabetes and CHF. This will be true because even if such research shows which treatments are best, if clinicians aren’t following these recommendations in standardized ways, the value of this knowledge for patients and the healthcare system will be dramatically diminished.
Including physicians, other clinicians, and other stakeholders in the development and implementation of standardized practices will be critically important for their successful adoption and use – because as was seen in the dramatization in the ER episode, big personalities of individuals can overshadow, subvert or sidestep the proper use of standardized practices so that they may be followed in substance, but ignored in spirit.

Transparency & Accountability for Physicians in Health Reform

Posted on March 12, 2009 by Michael D. Miller MD

Yesterday I had the opportunity to give Medical Grand Rounds at Caritas Carney Hospital in Boston on the topic of “Health Reform 2009 and Beyond.” Rather than compare and contrast various national health reform proposals, I reviewed the major forces and trends that are reforming healthcare, and explained how they would likely impact different stakeholder groups – particularly physicians.

I started by discussing the major trends in cost, access and quality – noting how the first two are easier to quantify and that the debate over access to healthcare services versus insurance coverage has been resolved in favor of health insurance coverage, because only having access to free clinics and emergency rooms doesn’t enable people to get the type of healthcare that they really need. The successor debate is what insurance needs to cover to be “adequate,” and what it means to be underinsured.

Transparency & Accountability
The heart of my talk was explaining the role of transparency and accountability in health reform at the national, state and private sector levels. (One of the earliest forms of transparency for clinicians was the National Practitioner Databank, which was created about 20 years ago to try and make it easier for the healthcare organization, insurers and government agencies to learn about adverse actions – such as malpractice suits and licensing board censures.)

“What are we getting for what we’re paying for?”
The most frequently discussed transparency initiative in healthcare is the big push for electronic health records. Information and transparency are being highly valued because as more detailed information about actual clinical and cost outcomes becomes available, it can be analyzed and used to make different parts of the healthcare system accountable for their contributions. (Note: the apparent dramatic lack of transparency and accountability that contributed to the collapse and impairment of so many financial institutions has fueled public calls for more accountability and transparency in many parts of society – including healthcare.)

Capitation was an early attempt to place accountability for the cost outcomes of individual patients onto healthcare organizations. However, because information connecting clinical decisions with overall costs was lacking, capitation was less than successful, and it often evolved into schemes to reduce the volume of care since that was the only measurement available related to total costs. Fortunately, accountability mechanisms have become more refined, and now include pay-for-performance, “episodes of care, and other forms of bundling of payments. (An example of an episode of care bundled payment would be a care group receiving a single payment amount for all the clinical services in a 30 day window for a patient receiving elective heart surgery.)

The common theme in this trend of transparency and accountability is that as costs continue to increase as a percentage of personal incomes, wages and GDP, insurance companies, private payers and employers, government agencies, and even patients are all asking, “what are we getting for what we’re paying?”

Power of the Pen
I also described for the physicians at Carney Hospital how as information systems become more sophisticated and can provide insights into the performance of smaller groups and individual physicians, more proposals and initiatives will seek to place greater accountability on the individual physicians because while physicians receive ~21% of all healthcare spending in this country, their actions influence how about 70-80% of each healthcare dollar is spent.

This concept is being translated into practice for Massachusetts state government employees, whose health benefits program has collecting and analyzing information about all the primary care physicians in the state, (and selected types of specialists), and then put them into three “quality tiers”: Excellent, Good, and Standard. Accountability is added to this transparency because patients seeing physicians in the “higher quality” tiers pay lower insurance co-payments.

There is significant controversy around this profiling and tiering program – particularly about what data is used and how it is analyzed. Certainly transparency and accountability are only valuable for creating positive changes when the data is valid and reliable – something I discussed with the physicians at Carney Hospital and have written about previously. The key challenge in making this type of data valid and reliable is how adequately it is risk-adjusted in the analysis so that clinicians and providers are “graded” based upon their actual skill and work, rather than on the type of patients they see.

Medical Homes as Positive Solutions for Physicians
Another example of how the “power of the pen” concept is leading to new models for accountability in healthcare is the Medical Home. I told the medical students, residents and attending physicians at Carney Hospital that Medical Homes might be a positive opportunity for physicians to improve the quality of care while accepting and managing more financial risk and responsibility. Since the details of Medical Homes can be very complex, my one slide description was: “Medical Homes are arrangements where a physician (or group) is responsible for coordinating individual patient’s care across all sectors of the healthcare delivery system and ensuring that the patient receives appropriate preventive care and self-management assistance.” Since financial compensation is often a concern for primary care physicians, I noted that payment for Medical Home services is in addition to reimbursement for traditional care services provided to patients, and it could be a flat (risk adjusted) payment per month per patient, while also including incentive payments for actually improving patients’ clinical outcomes and/or reducing the amount of healthcare spending they generated.

Challenges and Opportunities for Physicians
I concluded by noting that these changes present challenges and opportunities for physicians. The first challenge is that if physicians don’t participate and lead in discussions about national policy issues and local delivery system reforms, then changes will be made to them rather than with them. That is, they have the choice to “Lead or be Led.”

Such leadership also needs to be paired with collaboration – both within clinician communities and with other stakeholders such as administrators, employers, payers, government agencies and patients. (These are two of the “lessons learned” from Geisinger’s experience described by Paulus et. al., in their Health Affairs article last year.) During the Grand Rounds’ Q&A it was also noted that geography and location are important factors influencing the ability of physicians and hospitals to exert leadership and promote collaboration within communities. For example, Geisinger is the major healthcare delivery entity within a relatively contained geographic community. However, this observation illustrates the importance of multi-stakeholder collaboration, because without it, everyone is working in isolation, efforts are not coordinated, time and energy are wasted, and the outcomes provide little or no benefits to anyone.

Reviews & Outcomes
While the audience was attentive and only a few people left to answer pages, it is always hard to know how much a group benefits from this type of presentation. So I was very gratifying to receive this email review from one of the organizing physicians at the hospital:

“Thank you for the fabulous grand rounds at Caritas Carney Hospital yesterday. You obviously put a great deal of time and thought into presenting to us; your lecture was a remarkable overview of so many issues affecting our health care system today! You have a great mind to be able to have both the comprehension to understand these concepts, and the ability to synthesize numerous trends and ideas into an integrated presentation. Two of the best compliments to you are 1) docs stayed until the end of grand rounds and 2) our new insights inspired conversations and debates in hospital halls and offices all day long!” Mary Lou Ashur, M.D.

The last comment is precisely the outcome I was hoping to achieve, since just educating people about different proposals may not help build their understanding of the problems and possible solutions, not give them guidance for how they can get involved, etc. And from the picture below taken after Grand Rounds, I think everyone was happy with the result – even if I do have a funny smile.

Controlling Health Care Costs and Improving Quality with Effective Care Coordination

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

A study published by in the New England Journal of Medicine last week examining the effects of 15 different Medicare care coordination demonstrations received wide coverage by the general media. Unfortunately, much of this focused on the study’s overall finding that these programs didn’t reduce hospitalizations or Medicare spending. For example, the AP story’s headline, “Study finds bid to cut Medicare costs failed,” was used by many papers such as the Washington Times.

However, the actual study had much more complex, important, and useful findings, and the paper’s authors from Mathematica, (which Medicare contracted to do the analysis from this project), deserve a lot of credit for extracting meaningful information from this project.

Complexity of Medicare Care Coordination Demonstration Projects
The study was very complex and presented many analytical challenges, including:

The “study” involved 15 different and diverse “care coordination” programs: 5 disease management companies, 3 community hospitals, 3 academic medical centers, 1 integrated delivery system, 1 hospice, 1 long-term care facility, and 1 retirement community
Despite being called “care coordination” programs, the major intervention was nurses communicating with patients outside of the patients’ direct clinical care team
Most of the programs’ care coordinators didn’t have significant interactions with the physicians treating the individual patients – although reports were provided to the physicians
The primary outcomes the study looked at were hospitalizations and total Medicare costs

Given that physicians direct most clinical decisions and thus influencing overall healthcare spending, it is not surprising that third party programs were ineffective in changing clinical or cost outcomes. With the patient’s physicians not being directly engaged in the development and implementation of these programs, nor vested – either financially or cognitively – in the success of these care coordination programs, this outcome is not surprising. This is like expecting travel agents to improve the safety and efficiency of air travel, i.e. while they can provide information to individuals they are not engaged in the operations of the airplane or airports. [OK – that’s an overly simplistic example, but I think it helps make the point.]

Positive “Findings” From the Study:
Despite the disparate structure of the programs in this study, the authors found that the more successful programs:

Had greater in-person contacts with the patients – nearly 1 per month
Focused their efforts on individuals with higher Medicare costs
Had greater success educating patients on how to properly take their medicines
“Worked closely with local hospitals, which provided the programs with timely information on patient hospitalizations and enhanced potential to manage transitions and reduce short-term readmissions”
“Had frequent opportunities to interact informally with physicians”

Implications for Medical Homes
These findings reinforce the importance of focusing on the role of physicians in controlling and managing clinical care decisions – which overall account for up to 80% of all healthcare spending. This observation is consistent with the conclusions the authors of the Care Coordination study reach in their NEJM article about their findings being able to help support the implementation and success of medical homes: “The successful interventions also may offer more detailed lessons for medical homes about how best to educate and monitor patients, the types of patients for whom they are likely to be most effective, and how to help patients overcome barriers to better self-care.”

This is a very timely and important conclusion since Medicare is getting ready to launch a Medical Home Demonstration Project in 8 states – and possibly more through legislation enacted last summer. Medicare’s Medical Home Demonstration has a greater likelihood of improving quality and lowering costs than the Care Coordination project because the Medical Home Demonstrations will directly put the responsibility for care coordination and improving patient self-management on the patients’ individual physicians – as opposed to providing an outside service for patients. In addition, similar to the two somewhat successful Care Coordination projects, the Medical Home Demonstrations will focus on Medicare patients with chronic conditions.

Implications for Overall Health Reform Efforts
The Care Coordination study’s observation that the successful programs differed from the unsuccessful ones in how they improved patients’ compliance with medications also has implications for broader health reform initiatives. It makes sense that patients with chronic conditions who aren’t receiving adequate medicinal treatments would have increased costs and hospitalizations, and thus improving compliance would reduce both. This finding, along with studies about the costs associated with medication errors, point to the value of focusing on medication compliance and proper usage in initiatives for reforming healthcare delivery.

For example, improving medication compliance might be improved by creating better written instructions for patients. An analogy might be to the checklists that help surgical teams and physicians placing central IV lines reduce errors and infections. Individualized patient “checklists” created in a standard format could help patients with chronic conditions take their medicines correctly and thus improve quality and lower costs. And of course, these “checklists’ should also include ALL the patient’s medicines, reminders about avoiding certain OTC medicines and herbal supplements that might interfere with their prescribed medicines, and to urge them to promptly inform their physicians if they develop certain signs or symptoms related to their medical conditions.

All of this really goes back to the benefits of improving patient-clinician communications, and strengthening their joint engagement with the broader care team that includes pharmacists, nurses, specialized clinical educators, and family members as appropriate.

Strengthening Care Teams Through Better Communications
Such checklists and more standardization of care protocols – for use by clinicians as well as patients – should help foster this communications and team-base management. However, if they are viewed by anyone in the team as cookbook medicine, or impersonal standardization – rather than guidance to protect against overlooking important actions and opportunities – then these protocols will not produce positive clinical and economic outcomes. To encourage positive attitudes and actions about such quality improving changes, clinicians and patient advocacy leaders of all types – and at all levels – will need to be educated about the value of such shifts in clinical operations, and for them to be promoted as champions of these new paradigms for clinical care. (Group visits for patients with conditions like diabetes or congestive heart failure are an example of care delivery innovations that can increase quality and lower costs through greater efficiency and engagement of patients and their care team.)

Changing Reimbursement to Support Care Delivery Reforms
Making these changes to the clinical care delivery so that they are attractive to clinicians – both in private practice and in larger care delivery systems – will likely require altering reimbursement systems to change the financial incentives. The Medicare Medical Home Demonstration project seeks to do this by directly paying physicians for their medical home management activities.

While this Demonstration is being implemented, a more widespread and timely change in Medicare’s physician payment system may happen this year because of the unsustainability of Medicare’s “Sustainable Growth Rate” formula. Under the current SGR formula, Medicare payments for physician services are expected to be reduced by ~22% starting in January 2010. Deliberations to avoid this “broadsword” financial cliff may be a leverage point for making such changes – although it is unlikely that a dramatic, wholesale change will occur immediately. It is more likely that significant changes will be phased in over several years and across geographic regions. A gradual implementation makes sense since it provides opportunities for clinicians and Medicare enrollees to become familiar with the new payment and clinical delivery structures, it enables champions for better care delivery methods to be created, and it allows those who are more cautious to observe the changes while they are implemented for and by others.

Communicating Health Quality Measures

Posted on February 15, 2009 by Michael D. Miller MD

Educating patients, (a.k.a. “consumers”), to make the “best” health care choices has been a fundamental principle in some health reforms schools, including those advocating for more high-deductible health plans. While this concept makes sense in economic theories, it also requires belief that patients can and will make good use of the information available to them – particularly when they are ill.

Another fundamental necessity for making such consumer-directed healthcare work to improve quality and lower costs is that the information provided to people is meaningful and accurate. A study published in the November/December 2008 issue of Health Affairs illustrates the complexity of providing accurate information.

This study was based upon the very simple question, “How easy would it be for a patient in the Boston area to find the “best” hospital by using different quality rating services?” And the results were pretty fascinating: 5 different ratings systems designed to provide the public with quality information about individual hospitals didn’t agree on which were the best hospitals overall or even for specific conditions – even when the measure was death from a specific condition. For example, the article notes, “Neither the observed mortality rates nor the observed/predicted rates were consistent across [rating systems for Acute Myocardial Infarction]. The hospital ranked first by HealthGrades had the second highest observed mortality; it ranked seventh according to Mass QC [a state government run information system]. Conversely, Health Grades’ seventh-ranked hospital (the only hospital ranked statistically worse than average) was ranked first by Mass QC. This same hospital was ranked fifth in the nation by U.S. News and World Report for cardiology.”

Similarly the rating systems didn’t agree on the quality of care for heart bypass surgery:

Conclusions:
The study’s authors don’t just throw their hands up and profess rating systems to be complete failures. Rather they note that transparent quality information reporting can stimulate quality improvement activities within individual institutions, and they also make three recommendations:

Hospitals should embrace quality reporting and make sure that the data collected and the design of the analyses truly reflect the quality of care
Patient experiences must be a meaningful part of quality of care assessments
Quality rating systems must improve how they account for differences in the severity of illness of patients, (i.e. risk adjustment of the data), and for random variations

They conclude that more standardization of data collection methods, analysis and reporting may help improve the value of quality information and comparisons. These would be positive steps towards providing individual patients with better information they could use to compare their local hospitals rather than just to rate individual hospitals against national or regional averages.

Darwinian Politics of Health Reform in the U.S.

Posted on February 11, 2009 by Michael D. Miller MD

Tomorrow is Charles Darwin’s 200th birthday, and the Economist had a very interesting article about how his original theories have evolved over the past 200 years – and how a greater understanding of human evolution have revealed insights into human society and economics.

One of the most interesting observations in the Economist article is the differing levels of belief in evolution among countries. The article explains these differences as possibly arising from the country’s safety nets for vulnerable people, i.e., individuals who have less concern about being able to obtain food or housing may be less likely to believe in God and be more likely to believe in evolution. Essentially the linkage is this:

Better Social Safety Net -> Less Concern About Getting Food, Housing, and Healthcare -> Less Belief in God As Provider of Necessities -> Less Belief in Evolution

This theory is reflected in the Economist article’s chart (see below) which may indicate that Western countries with more organized, socialized and stronger safety nets are more likely to believe in evolution.

Darwinian Politics and Religion
As can be seen from this chart, the people in the United States are almost exactly evenly divided, with about 40% believing in evolution, 40% not believing, and 20% unsure. This split is essentially the same at voters, with the 20% unsure being the undecided voters in closely contested elections.

Implications for Health Reform
What this information may mean for health reform is that the disorganization of the U.S. health system may itself be producing fundamental resistance in the U.S. population to making changes which would strengthen the system and make it more organized. That is, placing a greater emphasis on God as a predetermining force for fate and less belief in evolution as a force for changing species and societies, may make people less willing to trust the government or national organizations as sources for addressing their personal needs or concerns.

This may mean that successful health reform in the U.S. will need to gather more support from religious leaders and groups. Campaign professionals have long realized that this can be key to winning elections, and some public health experts have recognized it as important for success in some public health initiatives. It remains to be seen how important the support of religious groups will be for the success of health reform at the national level in the United States. And if it turns out to be an important factor, if religious leaders line up to support health reform in the U.S. – whatever shape that reform takes.

Osteoporosis – Increasing Rates and New Treatments

Posted on February 10, 2009 by Michael D. Miller MD

A press release from the NIH yesterday announced a new discovery about the biology of bone remodeling that may lead to a new way to treat osteoporosis. The study, (published in Nature), described how a compound found in the blood helps control the development of bone destroying cells called osteoclasts. (Osteoclasts break down bone while osteoblasts build new bone – The balance between these two cell types determines whether bone density and strength stays the same, increases or decreases.)

Lead for New Treatments for Osteoporosis
The effects of this compound, (sphingosine-1-phosphate), on osteoclasts may lead to the development of new treatments for osteoposorisis since the existing treatments have focused on the activity of more mature osteoclasts and osteoblasts. That is, by medically modifying the activity or levels of sphingosine-1-phosphate, it might be possible to adjust the overall population of osteoclasts, and thus reverse or halt osteoporosis in an individual patient. However, because sphingosine-1-phosphate has also been found to be involved with the the development of immune system cells, developing such a treatment might be tricky. It is also possible that there are sub-types of this compound, some of which are involved in bone cell development, while others modulate immune cell production…. But only more research will lead to these answers.

Need for New Treatments for Osteoporosis
Osteoporisis is a significant medical problem, and one that certainly will be growing with the aging of our population. As the National Institute of Arthritis Musculoskeletal and Skin Diesease summarizes:

Osteoporosis is a major public health threat for 44 million Americans, 68 percent of whom are women.
In the U.S. today, 10 million individuals already have osteoporosis and 34 million more have low bone mass, placing them at increased risk for this disease.
One out of every two women and one in four men over 50 will have an osteoporosis-related fracture in their lifetime.
More than 2 million American men suffer from osteoporosis, and millions more are at risk. Each year, 80,000 men have a hip fracture and one-third of these men die within a year.
Osteoporosis can strike at any age.
Osteoporosis is responsible for more than 1.5 million fractures annually, including 300,000 hip fractures, approximately 700,000 vertebral fractures, 250,000 wrist fractures, and more than 300,000 fractures at other sites.
Based on figures from hospitals and nursing homes, the estimated national direct expenditures for osteoporosis and related fractures total $14 billion each year.

Incentives for Finding New Treatments
There certainly are incentives for developing new osteoporosis treatments. Not only is the population aging, but while less use of hormone replacement therapy by postmenopausal women may be leading to lower rates of breast cancer, it may also increase the incidence of osteoporosis. These and other factors will likely keep the market for osteoporosis treatments growing. It is already over $5 billion, not counting nutritional supplements and other complementary treatments. Time will tell if this new discovery leads to new treatments for osteoporosis (and possibly other bone diseases like rheumatoid arthritis), but if we don’t experiment, the answer will certainly be no.

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