Category Archives: Quality of Care & Safety

Innovative aspects to improving the quality of care and protecting patient safety.

Healthcare Turkey Talk

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Thanksgiving is a great occasion for learning what people think about the future of the US healthcare system.*  This year, I’m going to find out what people are thinking about some of the coming health delivery system changes – particularly Accountable Care Organizations (ACOs) and Patient-Centered Medical Homes (PCMH).

I’ve conducted this two-question informal survey with handfuls of people and found their level of knowledge and positive reactions equivalent to Congress’s approval rating, i.e. 9%.  This is worrisome, since if transforming the US healthcare system to increase value and quality will be partially based on ACOs’ and PCMHs’ superior care coordinating abilities, it will be hard to improve cost, quality, and access at the local level if the average person/patient doesn’t know what these organization are, there is inherent aversion to their names, or there is resistant to unexplained “changes.” (For example, several people I’ve talked to have thought Accountable Care Organizations seem like HMOs, and Patient-Centered Medical Homes are home care, nursing homes or hospice.)

So fair readers of this blog, let me know what you hear at your Turkey dinners and associated holiday events – and I’ll post back next week what I heard from my disparate and decidedly unrestrained friends and relatives.

 

*Unlike most meals and gathering of family and friends, Thanksgiving dinner goes on for a long time, there are no ceremonial interludes, and it is generally a sit-down affair so you can’t move on to someone else – or out the door. This means “Aunt Sally” can pull your ear or kick your leg (either figuratively or literally) for upwards of 2 hours about what’s wrong with the US healthcare system and what how to fix it.  My advice is to ask questions to find out root concerns and to gauge people’s understanding of the coming ACA changes in both healthcare delivery and insurance coverage.  Also, if you find yourself referring to a recent study from Commonwealth or Kaiser Family Foundation, (or a similar organization or government group), STOP, put food in your mouth and nod encouragement for them to keep talking, because quoting the best studies to someone impassioned about their healthcare will be about as successful as convincing your 7-year-old cousin that 3.14159 is a great dessert.

Patient-Centered Care? Or Not?

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The term “patient-centered care” has increasingly been used to describe healthcare structures that deliver better quality care – as well as often doing so with lower costs.  And today there was a news story about how some medical schools are assessing applicants’ interpersonal skills, something that is fundamental for being a patient-centric clinician.

While there are have been numerous articles demonstrating the value of patient-centered care and concluding that it is better and should be promoted – including those looking at the ill named “Patient-Centered Medical Homes” – I’ve found myself pondering the following questions:

“What type of care have clinicians been providing if it hasn’t been patient-centered? Has it been clinician/physician centered? Or revenue centered? Or just intentionally confusing and impersonal care designed to stymie the adoption of evidence based standards of care?”

“And along those lines, is the widespread delivery of non-patient-centered care the reason why the IOM concluded that it takes about 17 years for valuable healthcare information to be adopted into clinical practice? Or why Atul Gawande found that hospitals in other countries have widely adopted surgical checklists to reduce medical errors and adverse outcomes, while only 25% of US hospitals are using these checklists?”

I’m just asking….

Health Law Is Reforming System Via Market Forces

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All the controversial rhetoric about the new health reform law is missing a huge reality:  The law is driving dramatic changes in the real world.  Almost every major health delivery system is preparing to reorganize how they provide care to hundreds of millions of Americans by becoming Accountable Care Organizations (ACOs).

Health Systems are Voting With Their Wallets
The magnitude and level of financial interest in ACOs – and proof that it is not just cautious planning – were dramatically illuminated by recent actions and a Washington Post article:

  • On Thursday, HHS released the long anticipated proposed rule for ACOs and Medicare “Shared Savings.” For the rest of the day the Federal Register’s website was nearly shut down by people trying to download the 429 page document.
  • Today’s Washington Post article, “Complicated health-care law leads to payday for consultants,” includes figures about the tens of thousands of dollars consultants are charging for strategy sessions about how to think about ACOs, and the millions of dollars in fees they are getting for actually helping health systems to become ACOs. Health systems were signing consultants up for these engagements before the draft regulations were released because of their expectations of how dramatically competition among ACOs will change their financial incentives and structures. And some of the phrases in the article highlight the level of importance being placed on ACOs: “ACO frenzy,” “Oversubscribed,” “Glittering high fees” and, “I have never seen anything quite like this in my 35 years in this business.”

Bottom Line
I could write more about the proposed ACO rule, my interactions with health systems looking to become ACOs (and the organizations helping them), and how ACOs will very likely produce significantly more savings for Medicare than the Congressional Budget Office has projected, but the bottom line looks like this:

  • ACOs are happening.
  • The Medicare ACO/Shared Savings rule will shape their form, but not their creation.
  • ACOs – and their quality/efficiency incentives payments – will fundamentally transform health care in the US.
  • This transformation will be like an avalanche as health systems compete locally to demonstrate how much more Accountable they are to patients and payers, i.e. how they provide higher quality at lower costs than their competitors down the street or across the river.
  • While the official title of the new health law is the “Affordable Care Act,” it very easily – and perhaps more accurately – should have been called the “Accountable Care Act” because it is that part of the law which will actually lead to more affordable care for more people.

As always, stay tuned and keep your seat belts tightly fastened for the upcoming wild ride. Like a roller-coaster, the fun is just beginning.

Roller Coaster

Medical Homes (PCMH) in 2011 – Patient and Consumer Centric

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Patient-Centered Medical Homes (PCMH) are continuing to be a bigger and broader part of the real-world discussions about health reform and transformation in the US. According to the the National Committee for Quality Assurance (NCQA) at the end of 2010 there were 7,676 clinicians in 1,506 recognized PCMH practices in the US. This information was released last week by NCQA with their updated 2011 PCMH Standards.

Patient Centered Medical Homes 2010

Another marker of medical homes’ increasing pervasiveness is the blurb – “Home sweet medical home” – in the March 2011 issue of Consumer Reports magazine that starts with, “If you haven’t already heard the term ‘patient-centered medical home,’ chances are you will soon.”

Consumer Reports – “Home Sweet Medical Home”
The Consumer Reports blurb is part of an article about what primary care physicians wish their patients knew. Interestingly this longish blurb notes that any practice can be more patient-centric without being officially certified, and it lists the important features patients should look for:

  1. Can you get an urgent appointment within 24 hours?
  2. Can you reach somebody in the practice by phone at night or on weekends?
  3. Can you get test results quickly via e-mail or telephone, or on-line?
  4. If you have a chronic condition, is there a system for tracking how you’re doing?
  5. Does the practice include non-MD staff members such as nutritionists or nurse practitioners to help you manage your medications or chronic conditions?
  6. Does your primary-care doctor keep track of your treatment by specialists?

NCQA’s 2011 PCMH Recognition Standards, Elements, and Factors
The 2011 PCMH Standards NCQA released last week are much more detailed about what a primary care practice should look like to provide high quality primary care – and they are a logical evolution from their 2008 Standards. Specifically they:

  • Reduce the number of Standards from 9 to 6 – which should make them easier to understand and implement.
    • The 6 Standards have multiple Elements. And each Element has various Factors that contribute to the scoring for that Element.
  • Integrate newer health IT standards and requirements.
    • NCQA provides a cross-walk between the Elements and the corresponding Federal Meaningful Use requirements for health IT that enable clinicians to receive higher Medicare and Medicaid reimbursements.
  • Include a patient survey, which will be available in 2012.
    • The optional survey will provide more patient-centric feedback about people’s experiences and  enable practices to score extra points towards the recognition Tiers.

NCQA also continues to have three Tiers of possible recognition – with Tier 3 being the highest.The new NCQA standards also continue to have “Must-Pass” Elements (in bold/italics below) for the 6 Standards. And practices must score at at least 50% on all those Elements to receive any recognition Tier.

Standard 1: Enhance Access and Continuity
Access During Office Hours, e.g., same day appointments and telephone or email communications

Standard 2: Identify and Manage Patient Populations
Use Data for Population Management, e.g., using medical record data to remind patients about getting evidence-based care for specific preventive services and treatments for chronic conditions

Standard 3: Plan and Manage Care
Care Management, e.g., individually written care plans and addressing barriers to patients achieving their treatment goals

Standard 4: Provide Self-Care and Community Support
Support Self-Care Process, e.g., providing educational resources and tools to enable patients to improve their self-care and healthy lifestyles/behaviors

Standard 5: Track and Coordinate Care
Referral Tracking and Follow-Up, e.g., coordinating and following-up on referrals to specialists, including testing done by specialists and their recommended treatments

Standard 6: Measure and Improve Performance
Implement Continuous Quality Improvement, e.g., setting goals and acting to improve care for patients with chronic conditions, (such as diabetes, heart disease and depression), and preventive services, (such as immunizations, and cancer and osteoporosis screening)

It is also worth noting that among the various Factors that make up the Elements, NCQA designate some as “Critical Factors,” i.e., they are required for any scoring on that Element.  And two of these Critical Factors are for Must-Pass Elements:

  • “Providing same-day appointments”
  • “Develops and documents self-management plans and goals in collaboration with at least 50% of patients/families”

Thus, to achieve any level of recognition as a PCMH from NCQA, practices must have these two capabilities.

Conclusions:
While it may be coincidental that Consumer Reports lists 6 criteria for patients to consider in evaluating primary care practices for their “medical homeness,” and NCQA has 6 Must-Pass Elements, the two lists do parallel each other.

NCQA and Consumer Reports are targeting different groups of stakeholders – which is appropriate. NCQA’s requirements enable practices and providers to become recognized, while also informing payers and regulators so they can determine how to utilize a practice’s recognition in their policies and practices – including reimbursement levels.

Similarly, Consumer Reports is seeking to educate consumers, (a.k.a. patients and families). What is reassuring is that Consumers Reports doesn’t try to compare medical homes or clinics using its normal format of tables of numbers and those great red and black circle symbols.  That type of evaluation works well for commodities like TVs, but medical care is a process not a product, and it needs to be individualized for the patient – so what is a good medical home for one person may not be as appropriate for another.  (Atul Gawande’s recent New Yorker article “Hot Spotter” includes some examples of how cultural appropriateness can be a determining factor for the success of care for severely ill people.)

NCQA’s standards focus on structures and processes, and thus are not the beginning and end of what is needed for a successful patient-centered medical home. But certainly rigorous structural and process standards, combined with consumer education – along with other contributing drivers like cultural change motivators and incentives for achieving better outcomes – should lead to better quality, value, and efficiency in our health care system.

Let me know what you think about Medical Homes.

[Full Disclosure: I was given the Consumer Reports magazine by a friend who bought it because it has an article about TVs - and now I have to help her go buy a TV.]

Making Health Reform Work

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The May issue of Health Affairs focuses on Reinventing Primary Care – a topic that has been part of health policy discussions for at least 20 years. A few things have changed in that time: now there is better evidence about the importance of primary care providers in coordinating care to improve quality and reduce costs; the structural concept of this care coordination has been codified under the new term the “Patient Centered Medical Home,” (which has also been given precise parameters by NCQA); the complexity of medical care has increased so that the need for care coordination is greater; and electronic information storage, analysis, and communications technologies have been developed which – in theory – should make care coordination and the resultant quality improvement and cost control easier and more practical.

Health Affairs held a briefing on Tuesday about their May issue at the National Press Club.  Keynoting the meeting was HHS Secretary Sebelius. She rightly pointed out that healthcare delivery in the US is a “truly broken system.”  Her remarks touched on the various parts of the new health reform law that would help fix what’s broken, but the reality is that the Patient Protection and Affordable Care Act (PPACA) is very heavily weighted toward health insurance/financing reform, with comparatively little addressing delivery system reform.  Similarly, the Health Affairs articles are very heavy on the situation with primary care, the problems with our delivery system, and what a reformed (or transformed) delivery system should look like, but aside from reimbursement reforms, the articles have very little about how to achieve this transformation.

No “How” to go along with the “Who,” “What,” “When,” and “Why”
Like a good news story, a successful reform initiative needs to address the basic concepts of Who, What, Why, When, and How.  Unfortunately, the “How” part is frequently missing or minimal in most health policy discussions and proposals – aside from financial rearrangements. This heavy emphasis on financial incentives is because government programs like Medicare and Medicaid are significantly limited in what they can change outside their payment amounts and methodologies. And in the private sector, changing financial incentives is also the easiest thing to do.  In other words, changing reimbursements and other financial incentives, (such as pay-for-performance or bonus payments), is the lever most often used because it is the one that policy leaders are most familiar with, and it is the easiest for them to pull or push.

Challenges of Reorganizing the Unmotivated
Even though transforming healthcare delivery is based upon reorganizing the structure of healthcare delivery there has been very little focus on how to actually get physicians to participate in this reorganization.  While economists and others keep pointing to the economic incentives lever, it is pretty clear that physicians are not interested in reorganizing for the sake of improving their incomes. David Rotherman’s review of Timothy Hoff’s book about primary care physicians’ practices at the back of the Health Affairs May issue discusses how physicians like the current situation and their incomes. In this review he notes that it doesn’t appear that “primary care physicians have substantial dissatisfaction with the current system or levels of pay,” and that, “They seem comfortable as pieceworkers, not professionals.”

Thus, while policy researchers and payers correctly describe the great need for and value in delivery system reform, those actually delivering care seem to like many parts of the system – particularly their steady income stream and ability to run their own operations.  And while delivery system integration could solve many things clinicians don’t like – such as insurance and paperwork hassles – convincing them that working in a larger organization will significantly improve their lives is a difficult concept to sell. The challenge here is to overcome the inertia of change and getting them to consider the value of shifting from the “devil that they know.”

Private Medical Practices are Small Businesses
Another way to look at this is to see primary care physicians as small businesspeople.  As Boedneheim and Pham illustrate in their Health Affairs article, “Primary Care: Current Problems and Proposed Solutions,” 88% of primary care physicians are in practices with 5 or fewer physicians: 32% in solo practice, 14% in two person practices, and 32% in groups with 3-5 physicians.

What distinguishes these small businesses from non-medical enterprises is that because reimbursement systems using fee schedules create fee-for-service volume incentives, these physicians have very few business incentives to change.  Since their businesses are generally making a profit, and most physicians’ training and skills are not in running an efficient business, they few reasons to change their businesses operations.  While classic economic theory would disagree with that statement, and posit that their incentive should be to improve efficiency to increase profits, the reality is that people don’t like change – and they generally need to believe there there will be a 2:1 return for their financial or psychological investment before they are willing to undertake changes.  And small business practicing physicians don’t want to make those changes because they are concerned that no matter what the policy rhetoric states, they believe that any changes will decrease their income.

In addition, physicians generally believe that proposed health delivery transformation changes will reduce their autonomy – something they may value as high, or higher, than their income since it may be one of the reasons they became physicians, it may be why they are practicing in a small group or solo practice, and autonomy of clinical decisions is part of how physicians are trained.

Conclusions – How to Go About Achieving Health Transformation
Transforming healthcare delivery in the US will not be as simple as paying more for primary care services, and/or training more primary care clinicians, and/or training all physicians to work in team-based environments rather than as autonomous clinicians.  While all those are good things that certainly should be done, reforming how clinicians are trained will take 20-30 years to produce significant changes in the makeup of the US clinician workforce – and maybe even longer to change the ratio of primary care to specialty practitioners.

Therefore, what is needed is more emphasis on non-financial levers that can be used to alter physicians’ attitudes and actions around improving healthcare delivery – including their immediate practice situations, and how they relate to other providers and their patients.  Changing financial incentives can certainly support this, but it is very unlikely to successfully produce these changes in isolation.

Rather, some of the general principles involving the adoption of innovations should be applied to bring physicians – and other community care leaders – to be more receptive and participatory in making delivery transformation both a reality and a success. These principles, (as described by researchers in the 70s and 80s), have been applied to improving the quality of hospital care by organizations like the Institute for Healthcare Improvement, and include providing information about how simple the proposed changes are and how comparable they are to the clinicians existing day-to-day actions, and making it possible for clinicians to observe and/or try out these changes before they have to adopt them.

One of the major catalysts for using these principles to successfully implement reforms is to use change agents to communicate the value and reality of the proposed practice changes, and to simultaneously diffuse misconceptions and fears about them.  Since the old adage about physicians is that you can tell them, but you can’t tell them much, the best change agents for leading physicians through this transformation are other physicians who have participated in and/or observed, and/or analyzed other practices that have gone through similar changes.  There are also two caveats about these change agent leaders.  First, they need to be seen as independent and not biased or conflicted for financial or other reasons.  And second, they must be able to culturally and geographically connect to the clinicians they are trying to educate and lead.  For example, information about practice transformations in Vermont aren’t going to have much traction with physicians in Texas, nor are the experiences of Philadelphia practices going to carry much weight with physicians in rural Illinois.

Afterward: “Making Health Reform Work” Book Project
These concepts and messages about care delivery transformation using the principles of innovation adoption and stakeholder engagement are at the core of what I’ve been trying to construct into a book containing logical and understandable prose and graphics.  The working title for the book is “Making Health Reform Work.” However, the passage of health reform and its impending implementation have overtaken my ability to finish it. Therefore, I wanted to put forward some of these ideas here to stimulate more discussion about these issues and concepts because I strongly believe that without a broad based and balanced approach to health delivery transformation, significant efforts and money will produce suboptimal results and leave a bad precedent for future transformation and quality improvement efforts.

The Internet Solves Everything in Healthcare – - – NOT

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Improving healthcare will require people having better information.  That concept is generally agreed upon.  The challenge is getting the right information to the right people at the right time.  That is the interconnected goal of different facets of health information technology – from EMRs and PHRs, to health information exchanges.

People Are Complex
However, the complexity of medical care and individual variability – both human physiology and patient preferences – makes collecting and analyzing health information so that it is useful for individual clinical decisions much more difficult than presenting information about TVs, computers or cameras on a website such as CNET.

However, that distinction is not apparent to a friend of a friend who I had dinner with recently.  This person told me how the internet will solve everything in healthcare by making quality information from patients available to everyone else so that drugs don’t need to be approved by the FDA and doctors don’t need to be licensed. He also believes that this full access to information from other people about the quality of every health care option – from specific medicines to individual surgeons – will make health insurance unnecessary, since people will be able to decide what they want to pay for based upon how high a quality of care they want to obtain.

As a polite dinner guest of a friend I didn’t argue with his Libertarian perspectives.  Rather I tried to point out the complexity of analyzing health information because of different patient specific factors, and why risk adjustment is very difficult in assessing the quality of any healthcare option.  For example, I mentioned the piece I wrote last winter about a study of different assessments of hospital quality in Massachusetts, and how this showed the difficulty of exactly what this person believed should be easy and currently possible, e.g. if you were a patient in Massachusetts trying to decide which hospital you should  go to for a specific condition, how would you decide.  As I noted then, the different quality assessments came to conflicting conclusions.

Profit Seeking Isn’t Always A Good Thing
I also noted how the profit motive can lead unscrupulous people to sell fake medicines that can actually do more harm than no treatment at all – such as fake anti-malarial pills containing aspirin, which don’t treat the malaria but do reduce the fever so people think they are getting better. Similarly, the concept of modern snake oil salesmen taking advantage of people’s hope was reinforced by a recent cartoon in the New Yorker showing two people looking at a display of pill bottles adorned with a sign saying “As seen on TV,” and the caption reads, “The active ingredient is marketing.”

However, I found my insights didn’t make much of an impression, and I did make a faux pas by pointing out that there was $1.1 Billion in last year’s stimulus bill for research to get more of this type of information and make it available to people.  Unfortunately, this fact only elicited a shaking head in hands response which I took as his disgust at more wasted government/taxpayer money.

“Living is Easy With Eyes Closed, Misunderstanding All You See”
While for those of us not blinded by the limited wonders of computers and the internet, and who understand the complexity of actual healthcare decisions and analyses, the challenge is communicating this reality to people who believe that the internet is rapidly solving all our information problems…… As a society our goal should be to convey this knowledge to people before they or a family member becomes seriously ill – at which point the complexity of making healthcare decisions will be immediate and personal.  And just as there are no atheists in foxholes, people facing serious life altering medical decisions want validated and reliable information, not subjective, anonymous opinions from the internet – which may be fine for picking a restaurant, but is certainly problematic for picking a surgeon or a medicine.

Checklists and Physicians’ Behaviors

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

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

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

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

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

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

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

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

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

Off-Label Communications: Is More Less?

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

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

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

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

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

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

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

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

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

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

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

Happy Sausage Making - 2009

Encouraging Communications About Patients’ Goals

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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:

  1. Place the patient at the center
  2. Individualize
  3. Welcome family and loved ones
  4. Maximize health influences within care
  5. Maximize health influences outside of care
  6. Rely on sophisticated, disciplined evidence
  7. Use all relevant capabilities – waste nothing
  8. 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.

Real Health Reform in Massachusetts

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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:

  1. 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.)
  2. 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.
  3. 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.
  4. 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.”)
  5. Pay-for-performance (P4P) incentives to ensure appropriate access to care, and encourage quality improvement, evidence-based care, and coordination of care.
  6. 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.
  7. 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.
  8. Cost and quality transparency. ACOs will report performance against common metrics measuring health care quality and access to appropriate care.
  9. 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:

  1. Establish the methodology for global payments
  2. Establish the parameters defining an ACO
  3. Analyze health system data to support providers, patients, and employers in making coverage and care choices
  4. Recommend the necessary infrastructure support for providers
  5. Establish transition milestones and monitor progress towards those goals
  6. 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.)

Maco Shark 2~Maco Shark

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.