A Forum for Discussing and Analyzing Healthcare Issues
About  |  HealthPolCom Consulting  |  Contact

Archive for the ‘Access to Healthcare’ Category

« Older Entries
Newer Entries »

30% Off Health Care

By Michael D. Miller MD
April 27th, 2009

I get lots of emails.  Some are interesting.  Others are Spam – such as the one offering to double my gas mileage by showing me how to run my car on water.  (Don’t they know that cars run on air not water!!!!!)

And last week I got one promising to cut health care expenses by 30%.  Not just my health care expenses, but the entire countries spending on health care. (See their promotional coupon below.)

30% off health care coupon

As you can see, this is really a call for people to support a public plan as part of health reform.  This is a great message and marketing gimmick, but the problem is that nobody has agreed on the definition of a “public health insurance option.”  For example, Nancy-Ann Deparle, (Director of the White House Office of Health Reform), has said that a public plan could be like the Federal Employees Health Benefits Plan, which offers government employees a range of private insurance and managed care options.  But I haven’t heard anyone suggest that the FEHBP has reduced costs or premiums by 30%.

The 30% figure probably came from the Lewin Group’s analysis of how many people might go into a public plan option and how much it could save.  Their report put some numbers around the obvious conclusions that the lower the prices the government plan paid for healthcare products and services, the less it would cost and the number of people going into such a plan would be greater. They specifically found that, “If Medicare payment levels are used in the public plan, premiums would be UP TO 30 percent less than premiums for comparable private coverage. [emphasis added.]

Another factor that could influence the structure of a public plan, (if one is created in this thing we’re calling health reform), is that paying for healthcare care based upon each service, (a.k.a. fee-for-service), is being widely blamed as a prime cause for healthcare inflation.  And many payers - including the state of Massachusetts - are looking for other ways to pay for healthcare, such as making payments based upon quality or complete episodes of care….basically anything but fee-for-service (FFS).  Thus, the long term viability and cost savings of a public plan based upon Medicare-like FFS reimbursements is questionable. However, creating a public plan based on payment systems that aren’t yet widely used - such as global payments - also seems problematic.  And going the route of Massachusetts, (whose Connector is very much like FEHBP), seems too simple and probably won’t produce significant near term savings.

All this leaves me wondering what will happen, and if there are fourth, fifth, or sixth options?

Posted in Access to Healthcare, Delivery of Healthcare, Federal Healthcare Reform, Health System Reform, Politics | 4 Comments »

Culture of Health Reform

By Michael D. Miller MD
April 13th, 2009

One of the challenges for health reform legislation is the culture of the policy and political community.

Massachusetts’ insurance and coverage initiatives have been cited as lessons for health reform at the Federal level and other states.  However, while observing a meeting of the state’s Special Commission on the Health Care Payment System last Friday, I was struck by how the culture of this group was very different than what I have often seen in Federal processes or within other states.

The Commission had agreed at their previous meeting that global payments should replace fee-for-service as the main payment route for medical services and products.  At Friday’s meeting their discussion about what that system of global payments should eventually look like - and how to get there - was not confrontational, even though the Commission’s representation includes a wide range of stakeholders, including doctors, hospitals, two insurers, the state employees’ insurance plan and two elected representatives.

The collegiality and non-confrontational atmosphere of this Commission compared to national discussions of similarly broad groups - such as the Health Reform Dialogue - may provide important insights for other health reform efforts. The reasons why health reform in Massachusetts has this type of culture is probably a long list, but some of them might be:

  • The stakeholders realize that payment reform is part of longer-term cost containment efforts that will be necessary for the overall success of the state’s insurance expansion program
  • Despite the overall economic downturn, the state and its healthcare system are generally better off than other states and healthcare operations
  • The state has a generally progressive bent, and is somewhat culturally aligned, e.g. almost everyone is a Member of Red Sox Nation

Whatever the reasons for the agreeablity within the Commission and the state, progress thus far has been a significant achievement, and could lead the way for significant reforms at the Federal level or within other states - particularly if they can replicate a similar culture of cooperation and agreement.

Next Challenging Steps
Of course, the Special Commission won’t be making all the detailed decisions necessary for actually reforming payments, such as:

  • How quickly the new system will be initiated
  • How much the global payments will be
  • Who will get the global payments, e.g. hospitals, integrated delivery systems, physician groups, or some combination of providers
  • What types of quality information those receiving the payments will have to provide
  • What levels of cost containment will the new global payment system be expected to meet - and what measurements will be used to determine if costs are being constrained appropriately

Those types of decisions will be made by the state legislature and a government agency - or para-governmental entity created for these purposes.  These upcoming decisions and their implementations will be where the even harder challenges await.  However, given the Special Commission’s progress so far - and the state’s ability to implement and sustain the insurance expansion program - the likelihood that these harder steps will at least be partially successful seems good.  So while critics have been predicting the downfall of the Massachusetts insurance coverage expansion experiment because of rising costs, that’s not the future I see.

The political and policy leadership in Massachusetts seem to have a sustainable group-think and desire to keep on the path they’ve started on rather than veering off into another direction to achieve immediate cost savings or politically expedient gains. The ability of the state to do this will be aided by some of the factors postulated above, as well as the political clout the state has in Congress, and the Governor’s relationship with the President.  But those factors may change with time, so the ultimate ability of the state to sustain ongoing reforms and improvements to the healthcare system within the state may very well depend upon its momentum of success.  They’ve had great success in reducing the number of people without health insurance.  Now cost containment via payment system reform is the next success that must be achieved.

Posted in Access to Healthcare, Economics & Financing, Federal Healthcare Reform, Politics, State-Level Healthcare Reform | 2 Comments »

Managing Expectations for Federal Health Reform

By Michael D. Miller MD
January 28th, 2009

One of the challenges facing health reform legislation are the expectations of different stakeholder groups - many of whom were strong supporters of the Barack Obama’s campaign.  Although the new Administration has only been in office a week and a day, a number of signs point to the fact that health reform legislation will not be quickly formed and passed - including an article in today’s Boston Globe titled, “Some fear window is narrow for healthcare overhaul.”

But not rushing health reform was both predictable and a good thing.  First, the reasons why it won’t happen quickly:

  • It takes time for the new Administration and Congress to get organized - and they are rightly prioritizing actions to address the economic “situation”
  • The US system of government is designed to be deliberative and not speedily make major decisions
  • For reasons that are not fully apparent, the Senate is taking longer to confirm Tom Daschle as Secretary of HHS - although there are no signs that this won’t happen soon
  • Senator Kennedy’s health has been a question mark, but his staff has been working diligently to prepare legislative framework and language in conjunction with other Congressional offices such as the Finance Committee
  • Congressman Waxman’s taking over the Chairmanship of the Energy and Commerce Committee will likely mean some staff turnover in that Committee which also takes time - particularly since Congressman Waxman is known for getting some of the best and brightest staff in Congress

And second, not rushing health reform legislation through the process may be a good thing because no matter what scope and details the legislation eventually includes, getting more groups comfortable with its goals, priorities and specifics will make it more likely to succeed.  Some might argue that getting it done quickly will prevent any opposition from building up steam to defeat or derail it, but I believe that any interest groups seeking to do that will be more organized and quicker to the trigger than many others who would support it but might need more time to understand the legislation and rally their forces in its favor.

In addition, no matter how quickly legislation is written, passed by Congress, (and presumably signed by President Obama), it will still take a long time to implement.  For example:  Regulations will have to be written, published for comment, revised, and published in final form; Government programs will have to be revised or created - which entails moving people around or hiring new staff, and creating new forms and procedures for individuals and companies to report information to the government about their health benefit, etc.; Private companies will have to submit proposals for participating or providing services to the government for any new health programs (i.e. health insurance exchange, or new insurance plans).

All these things take time, so that actual substantive changes in how people get or pay for health insurance, how companies pay for employees benefits, or how the government regulates or provides health insurance will likely not occur for months or years after new laws are signed.  The exception to that process of course are modifications or expansions to existing programs - which is why the stimulus bill is looking at providing financial relief to states for their Medicaid and SCHIP programs to prevent or minimize cut-backs in those health insurance options for low-income individuals.

The bottom line is that health reform will be a long roller-coaster ride.  So pull down the safety bar until it locks in place, buckle your seat belt, keep your arms inside the car, don’t throw anything that could hurt your fellow riders or onlookers, and if you begin to feel ill, remember that everyone’s on the same ride, there will be dips and calm periods amidst the twists and turns, and this time it will most likely get done - eventually.

Posted in Access to Healthcare, Federal Healthcare Reform | 1 Comment »

Improving Cancer Care and Medicare’s Cancer Coverage

By Michael D. Miller MD
January 28th, 2009

The New York Times and Wall Street Journal both had articles yesterday about a new rule clarifying how Medicare would decide whether or not to pay for off-label uses of medicines to treat cancer.  These articles describe controversies around Medicare relying on several compendia containing information about such off-label uses to make these coverage decisions, how some of the compendia may have industry connections, and how the new rule might increase Medicare spending.

I have a long history with this issue.  As a Legislative Assistant working for Congressman Sander Levin in the early 1990s, I was very involved in writing the legislation that first changed Medicare law to require Medicare Part B to pay for off-label used of medicines to treat cancer.  This change was seen as promoting both good medicine and good fiscal policy:  It promoted good medical practice because there was evidence that physicians were admitting patients to hospitals to give them off-label chemotherapy for cancer because Medicare wouldn’t reliably pay for it in outpatient clinics.  Thus, patients had to travel farther, and were potentially at risk for hospital acquired infections and other problems from being in the hospital when they didn’t need to be.  And it was good fiscal policy because Medicare was paying more for these patients to be in the hospitals than it would for them to get the same treatments as outpatients.  This is why the Congressional Budget Office estimated that this change to Medicare law wouldn’t cost Medicare any money.  (They estimated saving for Part A of Medicare, and some additional costs for Part B, with the net costs being essentially zero.)

What the Times and Journal articles don’t mention is that under Medicare law, off-label coverage for cancer treatments also occurs if there is “supportive clinical evidence in peer reviewed medical” journals that have been approved by the Department of Health and Human Services.  (See the language for the entire provision in Section 1861(t)(2) of the Social Security Act.)  The peer reviewed literature option was included so ensure that Medicare paid for appropriate off-label cancer treatments for very rare or unusual cancers and treatments that might never make it into the compendia, and to include the most up to date published information for making coverage decisions.

The 1993 law, and the subsequent refinements to it, were designed to improve Medicare’s coverage for cancer treatments.  With about 50% of people with cancer being over age 65, Medicare’s policies thus drive many decisions about cancer treatments for all Americans.  And despite the requirements for off-label coverage, being treated for cancer certainly presents huge medical and financial burdens for many people – something that the creation of the Medicare Part D outpatient prescription drug program was intended to help with.  However, because of a peculiar wording in the 2003 law that created the Part D program, the coverage for off-label cancer treatments under Part D was more restrictive than under Part B.  (Essentially, it was easier to get Medicare to pay for an off-label cancer treatment when the medicine was injected by a physician than if the medicine was a pill.)  Fortunately – after a lot of discussion and lobbying by patient advocacy organizations including the Medicare Rights Center – that situation was changed by Congress in the summer of 2008.  So as of January 1, 2009, the rules for off-label coverage for cancer treatments are the same under both Parts B & D – although I’m sure there will be some snags and bumps in getting all the Part D plans up to speed on how to appropriately apply these coverage rules.

Balancing Costs v. R&D Incentives
How to control the costs of such treatments while also providing incentives for the development of new and better medicines is a difficult public policy balance.  Higher reimbursement amounts for cancer treatments would increase the incentives for developing new and better treatments and cures for cancer.  But high reimbursements could also increase costs for patients and their insurance companies.  This balance becomes particularly difficult when a new treatment is much more effective than previous treatments, it doesn’t produce very unpleasant (and costly) side-effects, it needs to be taken much less frequently, or if it actually produces a cure.  In such cases, the new medicine’s very high per dose costs can be criticized.  But this analysis may look very different when put into the context of the value the medicine provides to the patient, and the overall costs incurred by Medicare (or the private insurer) and the patient.

Cost & Clinical Effectiveness Research
Such challenging balances and calculations are what biopharma companies, biomedical researchers, clinicians, insurance companies, government regulators and others struggle with whenever a new treatment is developed for a serious condition.  This is the essence of clinical and cost effectiveness research – an area of health policy that is beginning to be much more widely discussed:  It has been part of bipartisan Congressional discussions and was highlighted in last year’s Presidential campaign.  How the government and others increase their support for this type of research, (i.e. inside government or through some independent or semi-independent agency), how the information from this research is reflected in reimbursement policies, and how clinicians are educated about and use this information, could dramatically improve the quality and value of the health care we all receive for cancer and many other conditions.  Only time will tell if that happens, or if too many competing interests snarl up the process with cost savings being put before quality improvement, with the goal of cost containment pushing the information into reimbursement decisions before it is fully analyzed – or as someone once said, trying to get to the dough before the bread is fully baked.  (Yeah, I know, very bad dough pun.)

Posted in Access to Healthcare, Comparative Effectiveness, Innovation, Medicare | 2 Comments »

Health Reform and the Economy: 4 Spheres to Consider

By Michael D. Miller MD
January 25th, 2009

Many people and pundits have opined on the effects that the economic downturn will have for the likelihood of health reform: On the Federal level, how much money will be available for expanding insurance coverage, and how much money will be included in the “stimulus package” - and for what? And in the States, how much will be cut from Medicaid programs and government employees’ benefits?  In addition, there have been news stories about the economic downturn leading to loss of insurance coverage secondary to job-loss, as well as people forgoing direct medical care, healthy activities, and wellness behaviors.

These points illustrate how the multiple parts of our health care “system” interconnect, (particularly financing effecting delivery), and everything existing within the overall economic environment.  [The economy’s effect on healthcare could be similar to how the percentage of oxygen in the earth’s atmosphere effected the development of different plants and animals in different eons.]

While the connection between healthcare delivery and financing is easy to see, research and public health are two additional – and important – spheres that make up our overall healthcare system:

Health System’s Four Spheres

As can be seen in the graphic above, each of the four spheres in our healthcare system interact with the others.  While it is obvious that delivery and financing are closely linked, it needs to be remembered that R&D and public health are activities that lead to better quality care, while also being tied to healthcare financing and delivery.

Implications for Health Reform Strategies
These relationships have implications for broad health reform strategies because making changes in one sphere will have effects in the others.  For example, not only will expanding insurance coverage for one part of the population – such as children – be a good thing for children, but it will also affect research and development and public health activities related to children.  For example, greater insurance coverage can increase incentives for more R&D into vaccines and for their use. But lower payment rates for clinicians to actually provide vaccinations (or higher insurance co-payments) can decrease those incentives.  Thus the overall outcome depends upon the balance of effects among the difference spheres.

Resource Limitations
It should also be recognized that resources are limited – both money and people.  So, for example, if a big push is made for information technology in healthcare, that will consume money and people, (administrators, researchers, clinicians and policy makers), so that there will be less resources for other areas.

My point is not to say that one issue or problem is more important than the others, but to put some structure around the concept that every action causes other reactions that can be either good or bad, and those possibilities need to be considered in analyzing proposals.

Since most proposals call for relatively small changes, it can also be illuminating to dramatically expand one’s viewpoint. For example, in exploring how to control healthcare spending, the extreme answer to the question, “What is the cheapest way to provide healthcare?” is “Provide no healthcare.” But obviously squeezing both financing and delivery to zero would also have significant undesired consequences in public health (and research), which would certainly not be good for workers’ productivity or the overall economy.  Obviously this is one of many examples of the old expression, (and storyline for millennia of parables), “Be careful what you ask for, you may get it.  Let’s hope that the consequences of this obvious and old axiom are one of the guiding principles for health reform.

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

Groups Seeking Funds in Health Reform

By Michael D. Miller MD
January 12th, 2009

With all the anticipation about health reform happening soon, many groups are expecting increased Federal funding for different things, e.g. electronic medical records, expansion of SCHIP and Medicaid (or at least great funding assistance to States), more emphasis on personalized medicine, more resources for FDA to help them with their expanding domestic and international responsibilities, closing the donut hole in the Medicare outpatient prescription drug benefit, fixing Medicare’s physician payment formula, etc.

Another area looking for increased emphasis and funding - both as part of health reform and economic/jobs stimulus - are biomedical researchers.  The Boston Globe and Mass High Tech had articles last week describing how the Massachusetts Life Sciences Collaborative is lobbying for more NIH grant money.  The reason for this being particularly important for Massachusetts is the state’s leadership in receiving NIH funding, receiving NIH funding of $344 per resident in 2007.  The Boston Globe’s on-line article contains these numbers, but the print edition also had a great graphic - the data from which is in the chart below:

NIH State Funding 2007 Source: Boston Globe/National Institutes of Health.  “Note: Data is preliminary and excludes some research contracts.”

NIH supporters were successful in doubling the NIH budget over 5 years, (from ~$13B to ~$27B from FY1998-2003), and this resulted in a significant increase in the number of researcher grants and the likelihood of grants proposals being funded. However, since then, the increases have not been as significant - See chart below:

NIH Funding 1993-2008
Source: National Institutes of Health (Years are Federal Fiscal Years)

The challenge of the new Congress and Administration will be to allocate dollars for both the stimulus package and health reform to have the greatest effect in the shortest amount of time.  Fortunately, the last Congress deferred many funding decisions e.g., the SCHIP program authorization expires in March, and the Continuing Appropriations law (PL 110-329) funds large parts of the government - including the NIH - until March 6, 2009.  Therefore, this Congress will need to - and have the “opportunity” - to address many funding issues sooner rather than later.

Posted in Economics & Financing, FDA, Medicaid, Medicare, Politics | No Comments »

Health Reform – Achieving Universal Coverage

By Michael D. Miller MD
January 5th, 2009

During the holidays the Obama Health Transition Team urged people to organize discussions about health care in their homes and communities – and then to report back. Reading about these discussions – including the one that Secretary Designee Tom Daschle attended in Indiana – made me think about what things are going to be needed to make health reform actually work.

My end-of-year reflections and ruminations led me to conclude that one of the most challenging parts of health reform will be to actually get more people enrolled in whatever expanded coverage plans are developed and implemented.  Enrollment barriers are not new, but they are frequently not highlighted because they may present great political and fiscal risks.

Eligible But Not Enrolled
Medicaid experts have long known that a significant number of people who are eligible for Medicaid but are not enrolled. According to a 2006 Report from the Commonwealth Fund, 62% of “uninsured children and two-thirds of uninsured, poor parents qualify for publicly funded health coverage programs but are not enrolled.”  And enrollment barriers have been seen in Massachusetts as it has implemented its health insurance coverage expansion program.  For example, Bill Walczak, the CEO of the Codman Square Health Center in Roxbury, (a low-income section of Boston), has stated that they have 1400 patients who are eligible for free health insurance, but they can’t get them enrolled because of paperwork barriers.

For several years, Washington DC has also had a health insurance expansion program called the Health Alliance.  Unlike the Massachusetts program, there are no mandates or penalties for not enrolling.  But, Bread for the City, which runs two free clinics in DC, has seen the same enrollment problems as Codman in Boston.  Both Codman and Bread have staff dedicated to helping people collect and submit all the necessary paperwork, but they still have significant enrollment barriers because of clients moving, not following up on mail, chaotic lives and trouble finding the right proofs.  I also suspect that literacy may be a problem for some people – since how can people respond to mail or find the right documents if they cannot read them?

Cost of Enrollment Barriers
Although the uninsured clients at Codman and Bread receive care when they show up, not having insurance makes it much more difficult for them to get needed medicines and specialty care.  And of course, not having health insurance hurts people in the form of poorer health.  This situation also hurts the clinics financially since they would be getting paid for this care if the patients were insured.  Codman’s CEO wrote that if their 1400 uninsured patients had insurance, they would receive an additional $250,000 per year – An amount that would make a significant difference in their ability to provide care to patients.  They face the quandary of whether or not to hire more people to help clients apply for free insurance, since this only makes sense if it brings in more money than it costs to hire someone.

In Massachusetts, Codman is not the only healthcare organization suffering financially from this problem.  The Cambridge Health Alliance recently noted that they may have to scale back services or close one of their hospitals because of shortfalls they are seeing under the new health program – some of which is due to their not getting paid for care they provide to patients eligible for insurance.

Uninsured in Massachusetts
The paperwork barriers to enrollment in Medicaid, (and other free or very low cost insurance programs), also raises questions about the number of uninsured in Massachusetts.  The number of people without insurance has certainly declined, with the latest report indicating that 2.6% of people don’t have insurance – a very significant decline from 7.4% in 2004 before the State’s new program began.

However, I’m curious about how well the surveys that generate these numbers are actually capturing the lack of insurance in vulnerable low-income populations – both because of the paperwork barriers and their higher rate of churning – even though the report indicates that rate of uninsurance for people below 300% of the Federal Poverty Level is more than 5% [See Chart below, and also see page 9 of Kaiser Family Foundation’s Medicaid Primer for discussion of the effects of “churning” on Medicaid enrollment.]

Uninsured in Massachusetts in 2008 Source: “Health Insurance Coverage in Massachusetts: Estimates from the 2008 Massachusetts Health Insurance Survey,” December 18, 2008

Solutions and Challenges
Certainly one solution would be easy and automatic enrollment.  Basically, this could be as simple as the patient signing a form stating that they meet the eligibility requirements for the health insurance program.  [Click here to see the Massachusetts Medicaid application]

The problem with a simple form is that it could lead to fraud – either by people who are not eligible so they can get free health insurance, or clinicians enrolling people so that they can just get bill Medicaid for services they aren’t providing.  One possible solution to this fraud problem would be to require that the form be signed by both the patient (or their guardian) and the clinician (or someone in their office that they designate), BUT only clinicians that the State has pre-authorized could sign and submit the auto-enrollment forms.  That way the State could limit the authorization to clinicians who already are providing care to large numbers of Medicaid patients, and thus reduce the number of organizations it would need to examine for fraud.  And of course these clinicians would be responsible for attesting that these patients are believed to be eligible for the Medicaid program.

Such a system could work by having the enrollment counselor at an authorized clinic go over the eligibility criteria with the patient, and if they meet the requirements, then together they would fill out a one page form.  Such a form could have the patient sign a single line which reads something like: “I believe my income is below the level required to be in the Medicaid program, as it has been explained to me by _________________ [Name of person signing below].”

And the person assisting them from the clinic would sign below stating, “I attest that, to the best of my ability and in good faith, I believe that __________________ [Name of person filling out top part of form] meets the requirements to be eligible for Medicaid.  I also understand that signing this form without having discussed the actual requirements with this person or reviewing any documents they have provided or are otherwise available to me which may indicate whether or not they meet the eligibility requirements, constitutes fraud and may subject me and _________________ [Name of organization] to financial and  criminal penalties – including imprisonment.  In addition, if the person signing the top of this form is found to be fraudulently enrolled in Medicaid, they could also be subject to financial and criminal penalties.  Thank you for assisting with this process.  Your contribution to improving our healthcare system is greatly appreciated. Have a great day!”

I’m sure there are problems with such a simple form, and that other people could improve on that language.  And I invite comments, edits and criticisms to this suggestion because unless we figure out how to actually enroll eligible people in free health insurance programs, then universal coverage will remain a vision outside our grasp. [Also see the Commonwealth Fund Report on how auto-enrollment might work and what Federal policies would facilitate auto-enrollment.]

Closing Observation
Anticipating that someone will suggest that other countries – like England – have figured out how to do universal enrollment and don’t seem to have the fraud I’m concerned about, I would like to note that a major operational difference between our system and England’s National Health Service is that the NHS employs the physicians and owns the hospitals, whereas Medicaid reimburses for specific clinical services.  What this means in terms of financial fraud, is that the NHS has a fixed amount of money to spend each year, (like the Veterans Health System here in the US), and if they run short of money at the end of the year they have to cut back on the care they provide.  Conversely, Medicaid just keeps paying the bills.  So in England, if people are fraudulently enrolled in their system, they are just “stealing” resources from others in the form of preventing or delaying other people from getting the care they need.  Conversely, Medicaid fraud results in Medicaid spending more money, but access to care for those who are legitimately enrolled isn’t significantly compromised because Medicaid doesn’t “run out of money” the way the NHS or the VA can.

Posted in Access to Healthcare, Delivery of Healthcare, Health System Reform, Medicaid, Public Health | 3 Comments »

Health Reform - How Much Expansion?

By Michael D. Miller MD
December 12th, 2008

Morton Kondracke, a columnist for Roll Call newspaper, (sorry on-line subscription required to read the full article), had a very interesting and insightful piece yesterday where he outlines some of the reasons that health reform in 2009 will be more expansive than in might have been a few years ago.

He makes two very concrete and connected observations.  First, that the economic downturn will increase the number of people without health insurance by 5-6 million, and probably add a similar number to the rolls for Medicaid and SCHIP - which will add to States’ budgetary problems.  And second, that the costs of health reform are likely to be much greater than expected - assuming of course that there isn’t a dramatic economic rebound.  The number he puts forward is “more than $3 trillion” over 10 years.

Higher costs are largely due to a greater number of people without health insurance, which would be consistent with the experience in Massachusetts:  In Massachusetts the initial estimates of the number of uninsured were too low, and more people than projected enrolled in subsidized plans resulting in higher than expected costs.  More people having health insurance is a good result from the perspective of moving towards universal coverage, (and for all the benefits it provides to individuals and society), but it is a bad result from the budgetary perspective.

How these expanding challenges are met in what is actually agreed to for health reform in the coming months, (for the legislation), and years, (for the regulation and implementation), will be important for both our individual and national health and finances.  While it would be nice to say that it is important that health reform be done “right,” because so much of what will be done is new - either in substance or scope - that I think it is more realistic to hope that the specifics of health reform don’t include too many missteps or components that need to be significantly revised in the future to correct unexpected outcomes.

What do you think?

Posted in Access to Healthcare, Economics & Financing, Public Health | 1 Comment »

Personalized Medicine - Fulfilling the Promise of Genetic Research

By Michael D. Miller MD
November 17th, 2008

It has been 55 years since the discovery of the structure of DNA, and 40 years since James Watson published his account of that discovery in his book, “The Double Helix.”  (A picture of my autographed copy is below.)

Double Helix - James Watson - Signed Copy

Ever since DNA was discovered to code for the structure of most living things, there has been the hope that understanding abnormal genetics would lead to the ability to treat or cure a vast array of illnesses.  Unfortunately, that progress hasn’t been as rapid as originally hoped.  But medical science is now beginning to put genomic research discoveries into actual medical practice, and start customizing medical treatments based upon each individual patient’s genetic makeup - the fundamental concept of “Personalized Medicine.”

What are genetic tests and how are they used?
The simplest genomic tests are those that inform a clinician about the choice and/or dosage for a medicine to treat an individual patient.  This type of test is generally easy for clinicians understand and use since it provides information that it is very similar to antibiotic resistance testing - a test that clinicians have used for decades.  Currently, this type of genetic testing to guide pharmaceutical treatments is being used to guide chemotherapy for cancer - where the genomic make-up of the cancer cells can indicate susceptibility or resistance to certain medicines.  It is also being used in a few other ways, including identifying individuals whose genetic make-up indicates that they should receive lower (or sometimes higher) dosages of certain medicines.

New Reports on Personalized Medicine
Several publications and reports have come out recently about advances in Personalized Medicine.  The most recent of these was three articles in the November/December issue of Health Affairs.  These articles point out the challenges for turning scientific advances into better clinical and economic outcomes.  In discussing this very broad issue these articles emphasize the progression from the laboratory, to clinical research tools, to clinically useful tests that can provide information to guide medical care, to actual treatments designed to interact with or alter the individual’s genetic makeup.

There are obviously many additional facets and nuances to this progression, and it is a very challenging road on which reimbursement plays a very important part in determining speed of development and research priorities.  That is, reimbursement amounts and policies not only influence access to genetically-based tests and treatments, but they also create incentives that guide the development of future tests and treatments.

Another recent publication is from FasterCures, titled “Patients’ and Consumers’ Interests and Perspectives in Personalized Healthcare.”  This paper provides patient perspectives - which are not overtly addressed in the Health Affairs articles.   To present a broad picture of patients’ perspectives, FasterCures surveyed various groups and individuals, and they found that:

  • Patients are just beginning to understand the concept and potential of “personalized medicine” - although the term may not be recognized or fully understood by many people.
  • Many see personalized healthcare as an advancement that should be consistent with and support “patient-focused care,” and that it should help improve the quality and cost-effectiveness of healthcare.  However, many also recognized that new tests and treatments have the potential for increasing total healthcare costs - at least in the short-term.
  • Patients want to be educated and involved, not only in their direct clinical decisions, but also in the research and development process that relates to their particular health concerns.  And there was also a recognition of the tension between genetic testing being available, and the results of those tests being meaningful and useful.  (This tension was also discussed in the Health Affairs papers.)
  • And of course, patients are concerned about the privacy of their genetic information.

The FasterCures paper concludes with a 4 point Action Plan for speeding the process of making personalized healthcare a reality:

  1. Involve Patients in Medical Research
  2. Transform the Drug Development Process
  3. Protect Patient Privacy
  4. Focus on and Deliver Patient-Centered Care

Growing Interest and Meeting Information Demands
Interest in applying genomic research to clinical medicine is clearly growing, and genetic tests and treatments will increasingly become standards of care.  For this to happen, clinicians, patients, and other key stakeholders will need a greater understanding of these tests and treatments, and their proper role in clinical care:

Clinicians will need to keep up-to-date about the latest clinical applications involving genetic tests and treatments so they can educate patients in their role as “learned intermediaries” - the term sometimes used to describe how clinicians explain to patients what is causing their medical problems and what are the best treatment options.

Patients will need to be educated about the value and meaning of possible genetically based tests and treatments. And while physicians can do some of this educating, they have limited time.  This gap has begun to be filled by Genetics Educators - a masters level clinician who can work with patients to help them understand the implications of the results of any genetic tests or family history. While there is currently a shortage of Genetics Educators, in the future they may fill a role much like nutritionists do for diabetics, but for a wide range of genetically based tests, treatments and conditions.

And lastly, recognizing that there is a rapidly expanding need to educate other key stakeholders about genomic issues, the Personalized Medicine Coalition (PMC) was formed just over 4 years ago to “to foster understanding and adoption of personalized medicine for the benefit of patients.”  The PMC was started by a couple of dozen biotechnology, pharmaceutical and information technology companies and groups, but has grown into a much larger coalition that includes academic institutions, government agencies, patient advocacy groups, payers, clinical testing companies, and others.  Collaboration among these types of groups that will be necessary for developing, validating, determining appropriate uses and reimbursements for genetically based tests and treatments so that Personalized Medicine will become part of the solution for increasing the quality and cost-effectiveness of healthcare.

Posted in Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Innovation, Quality of Care & Safety | No Comments »

Medical Homes, Hammers and Nails

By Michael D. Miller MD
November 10th, 2008

Medical homes are being promoted as a way to improve health care delivery by increasing the coordination of patient’s primary and specialty medical care.  The goal of medical homes is to ensure that patients’ care is comprehensive, appropriate and patient-focused.

One of the benefits to the patients and the healthcare system is that medical homes can help sort out the confusion that can arise from the phenomenon sometimes described as, “When you’re a hammer, everything looks like a nail.”

Hammer & Nails

In healthcare delivery what this means is that sometimes the diagnoses or treatment recommendations from specialized clinicians will reflect their expertise - and thus their may be inconsistencies or conflicts in the recommendations coming from several  specialists. The challenge for the patient is to determine the best course of action for them.  And that’s where the value of their primary care clinician in a medical home - they have access to all the patient’s information and can help coordinate and translate all this information for the patient, so together they can make the most informed and appropriate decision.

This coordinating and translating task is important for acute and serious illnesses, as well as for chronic conditions - particularly when their is no generally agreed upon standard of care, of if the accepted course of treatment does not prove satisfactory for the patient.

This situation arose recently for a friend at the same time there was an article in the New York Times where the author described her nearly identical series of interactions (and frustrations) with the medical care system when dealing with hallux limitus or rigiditus - basically, limited motion of the big toe, accompanied by pain caused by bone spurs and/or arthritis.  The “hammer sees a nail” phenomenon here is that the surgeon sees primarily a problem that can be solved with surgery, while the podiatrist sees primarily a problem that can be helped by an orthotic.  As the New York Times author discovered, there may be other options that could work for her.  But from her writing - and my friend’s experience - this was discovered because of the patient’s diligence and not from the coordinating role of her primary care clinician in a medical home.

Another way to view the function of the medical home is to look at a medical home as trying to replicate the close interpersonal relationship between each patient and their primary care clinician that existed decades ago, while still enabling the patient to take full advantage of medical advances.  In addition, such relationship building could help reduce malpractice costs since it should improve both the quality of care, and patient-clinician communications about the goals and expectations from possible treatment options.

Challenges to Creating Medical Homes
Building these homes faces several challenges, including the shortage of primary care clinicians who need to be at the center of the coordination process working with patients and other clinicians to define realistic and patient-specific goals and treatment plans. Another challenge to creating well-run medical homes is that specialists may balk at being part of such a formal coordination process.

Implications for Health Care Reform
What this mean for health care reform is that while medical homes should be promoted, they cannot easily be created for everyone from our existing resources.  Therefore, they should first be built where they can have the greatest impact - for people with chronic and multiple medical problems, while at the same time our overall capacity of primary care clinicians is increased.  These two initiatives can be complementary because creating successful medical homes should increase the economic attraction of primary care as a medical career, while also demonstrating to medical students and residents the value and attractiveness of primary care when practiced in a medical home type setting.

In addition, other important health reform initiatives such as electronic medical records, and turning the findings from comparative effectiveness research into actual medical practice, will support of the creation of medical homes that can improve the quality of medical care, help reduce waste and improve the overall efficiency of health care delivery.

And lastly, it is clear that there is a desire for medical home type services since this is basically the concept underlying concierge medical practices.  For those not familiar with concierge medicine, this is where the primary care clinician signs up a limited number of patients who pay $1,500 - $25,000 per year, and the clinicians commits to spending more time with them, will explain in greater detail their medical issues and options, and take on the role of coordinating their care amongst all needed specialists.  While I don’t have the data, I’m guessing that individuals who are are paying for these concierge services are not the patients who would receive the most clinical benefit from medical homes.  And clearly, with too few primary care clinicians, having these physicians limiting the number of patients they will see doesn’t alleviate that shortage.  So, while I understand the motivations and market forces driving the creation of concierge medical practices, given the current problems in our healthcare system, I don’t think they are pushing the use of limited resources in the best direction to benefit society overall.

Posted in Access to Healthcare, Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, Health System Reform, Information & Communications, Quality of Care & Safety | 2 Comments »

« Older Entries
Newer Entries »