Health, Healthcare, and Government Spending (and a Culture of Health)

Why governments care about health and healthcare, how they are connected to government spending and priorities, and why addressing social determinants of health is so important for making lasting improvements, were the subjects I covered in a presentation at George Mason’s graduate policy school in September. My goal was to provide the soon-to-be policy analysts and advisers with a framework for understanding those issues so they will be able to provide useful recommendations to their future decision making bosses. (See the slide below for the topics covered in the presentation.) Links to videos of the talk are below, along with short descriptions – I think that Part 6 is particularly good. (Embedded views of the videos are at the end.)

I’ve had discussions with policy makers and corporate executives about these issues since their organization’s value propositions increasingly require demonstrating individual and population outcomes with specific metrics. Those requirements are part of the broader rapid movement of the U.S. healthcare system towards more accountability. Consequently, the connections among health, healthcare delivery, spending, community organizations, and social determinants of health are becoming a top priority for healthcare and life science leaders in companies and government agencies as they seek to increase value for their organizations and the people they serve.

Any thoughts you have about this talk, the connections among health, healthcare, spending, and community health factors (a.k.a. social determinants of health), would be greatly appreciated. And if there are any aspects of these issues where I can be of help to you or your colleagues – or you know of organizations or audiences that would also benefit from a similar presentation – please just let me know as I’d be happy to discuss that with you.

GMU - 9-29-16 Overview Slide

Part 1: Introduction. Why Governments care about health and healthcare. What is health. What is healthcare. https://youtu.be/KvDVcBGOePc

Part 2: Insights into healthcare spending with a particular focus on the Medicare and Medicaid programs. https://youtu.be/6Onuae2c0Xw

Part 3: Why spending on (and budgeting for) health and healthcare programs are unlike almost all other Federal programs, and why projecting spending is so challenging. https://youtu.be/lyaAjRzD0ic

Part 4: How government and private payers are seeking greater value and better clinical outcomes from their healthcare spending, and how data and analytics are increasingly important components of developing and evaluating those initiatives. https://youtu.be/7abj14xIcMw

Part 5: Examples of value based pricing initiatives and the importance of data and analytics for managing such programs, determining “success”, and sharing savings with physicians, other providers, or patients. https://youtu.be/MeLZA5wcpG8

Part 6: How health, healthcare, and spending on government health programs (and private insurance reimbursements) connect to each other, and how social determinants of health can drive clinical and economic outcomes, i.e., how a culture of health can be so important for transforming health in a community. This Part concludes with a brief discussion of the Affordable Care Act and the future of that program and the U.S. healthcare system. https://youtu.be/66zt_Rqf9hA

Enjoy. Pass along to your colleagues and friends. And as always, constructive comments are welcome!

Specialty Drugs: Getting What We Asked For

The cost of so-called specialty drugs has become a major health policy issue largely because of spending projections for new medicines for chronic hepatitis C infection and cancers.  Having worked on issues related to the development, approval, availability, use, and cost of medical treatments for more than 25 years, I’ve noted with concern and bemusement how cost and value issues are being discussed and presented in public debates and policy circles.

The Intense Debate About New Biopharmaceuticals Was Predictable

The introduction of significant new specialty medicines is reasonably predictable because information about biomedical research and the developmental status of new drugs and biologics is publically available from the FDA and company press releases. And while the specific list prices of new medicines can’t be precisely known before they are approved and launched, with a basic understanding of healthcare economics approximate price ranges are reasonably predictable. (Both of these are discussed below.)

So how does something that was predictable also become so contentiously inflammatory?  The intense debates and diatribes about the price and value of new biopharmaceuticals is not surprising because of the rancorous politics surrounding healthcare in the U.S., and the apparent lack of research and foresight by organizations involved with paying for medical care.  (Neither of these are discussed below.)

The overall situation seems to boil down to that, as a society, we’ve gotten what we’ve asked for in terms of new treatments based upon billions of public and private dollars invested in biomedical R&D, but we are now very upset with the result. An analogy might be someone who wins a new car on a game show, but is then very surprised and upset because they have to pay income taxes on the value of the car, pay to register the car, pay for insurance, pay for gas, pay for maintenance, etc.

To examine this situation more deeply, let’s step back and look a bit closer at what the new (so-called) specialty medicines are, how we’ve been asking for them, and why they are not generally the fiscal crisis many have been Chicken-Littleing about.

What are Specialty Medicines?

Specialty medicines are not a specifically defined category of medicine or medical therapy.  The FDA approves and regulates medicines for human uses in the general categories of pharmaceutical drugs (which are mostly small molecules), biologics (which are mostly proteins or other very large compounds produced in living cells), insulins, vaccines, and blood and tissue products. Across those categories the FDA recognizes orphan medicines as therapies for conditions that affect less than 200,000 people in the U.S. The FDA also has pathways for more rapidly approving new medicines based upon clinical need, as well as for expanding access to experimental compounds prior to FDA approval. There is no category for “specialty drugs.”  (And as an aside, there is also no category for “biotech drugs”. Biotechnology is a technology, process or method for conducting research or creating new molecules.)

Similarly, the Centers for Medicare and Medicaid Services (CMS) has extensive provisions for how medicines are covered and paid for under various parts of Medicare (Parts B, D, and C), and Medicaid, but none of those include specific requirements related to “specialty drugs” based upon their molecular structure, method of production, medical use or need, patient population, or any other clinical factor. However, many health insurance plans (including Medicaid programs and Medicare Part D plans), have tiers for expensive therapies labelled “Specialty Drugs.”  This bottom line perspective was aptly described in an article[i] in Health Affairs’ October 2014 themed issue on “Specialty Pharmaceutical Spending & Policy”:

“There is no uniform definition of specialty medications. However, there is a consensus that all of them are high cost (Medicare Part D uses a $600 per month threshold for the “specialty” designation), are relatively difficult to administer, require special handling, or require ongoing clinical assessment—or have some combination of these four characteristics. All of the characteristics are routinely used to define specialty medications. However, one recent survey indicated that cost is the dominant factor, with 85 percent of respondents at health plans rating cost as very or extremely important in their decision to assign the specialty designation to a medication.6

The medications that have received that designation are a heterogeneous group. They include small molecules that are produced on an industrial basis, such as dimethyl fumarate (Tecfidera), which is used in the treatment of multiple sclerosis; manufactured human proteins, such as growth hormone; and exquisitely designed monoclonal antibodies (such as trastuzumab) that target cancer cells or help control an inappropriately stimulated immune system (for example, infliximab).”

So the bottom line is the bottom line: Specialty drugs are expensive drugs for which health insurance plans are requiring patients to pay higher co-pay/co-insurance amounts. And those higher financial requirements may be in addition to health plans’ other utilization management requirements such as quantity limits, prior authorization programs, and step therapy (a.k.a. “fail first”) protocols.

Why Specialty Medicines are The Same as Older New Medicines, Only Different (and Potentially Better)

Specialty drugs are expensive medicines – more expensive than medicines approved 10, 20, or 30 years ago, e.g., Prozac®, Epogen®, Invirase®, Lipitor®, Gleevec®, Avastin®. But they are also more likely to be effective, and/or treat conditions that did not have very good therapies. These newer medicines are generally the result of the evolution of biomedical science that is producing more molecularly targeted therapies. This advancement has been supported by public policy to promote more basic and applied research at the National Institutes of Health, academic research organizations, and biopharma companies, which in the U.S. totaled about $120-130 billion in 2012. (Why was has there been longstanding broad political and public support for increasing the NIH’s budget if not to push forward to create new treatments?)

Below is a graphic from the late 1990s that illustrates how biomedical advances have led to newer treatments.

Process of Discovery & Development - (c) HealthPolCom Blog

We are now in that period beyond 2005 represented in the upper panel by the large red “?” and the cornucopia of capsules in the bottom panel. That is, we have gotten in the 2000s what we had been asking for and paying for in the 1990s and earlier: Better treatment options.

And to expand upon this picture, the graphic below illustrates the major types of organizations involved with biomedical research, and how they interact and influence each other through the exchange of information.

Major Biomedical Resarch Stakeholders - (c) HealthPolCom Blog

How New Medicines Fit Into Clinical Care

With the newer targeted, molecularly based medicines, there is – by design – a greater match between the pharmacology and the patient’s physiology leading to better outcomes. This means there is a greater likelihood that the treatment will produce a good clinical outcome.  More precise matching of pharmacology to physiology also often means that the number of people who should be using the particular medicine is smaller than would have been the case for untargeted medicines developed when there was less understanding of physiology and pharmacology.

Below is a simple diagram (starting in the lower left corner) depicting how clinical decisions are made, and how more effective treatments can improve clinical outcomes.

Role of Therapeutics in Healthcare - (c) HealthPolCom Blog

Overall Value of Innovative Therapies

While any individual medicine may be innovative and provide value, as the “Process of Discovery & Development” figure above illustrates, these advances often involve treating a disease through a new mechanism of action, i.e., moving from one “therapeutic revolution” to the next.

Below is a simplified picture illustrating how the value of medical innovation can increase in several ways:

  • By developing a better medicine using an already targeted mechanism of action, e.g., a medicine with reduced or fewer side effects;
  • By developing a new medicine that targets a new mechanism of action, a.k.a. a new class of medicine to treat a disease; and
  • Research that discovers how an existing medicine can be used to treat another disease, e.g., methotrexate for autoimmune diseases.

The Value of Innovation - (c) HealthPolCom Blog

Discussed below is how a new medicine’s higher success rate for treating an illness often translates into a greater value and a higher price. Also discussed is why we shouldn’t be surprised that these medicines are expensive, and how our imperfectly regulated market-based healthcare system is responding.

Why Price and Cost of Specialty Medicines are of Concern, but Not Catastrophic

How are prices of medicines determined?  In much of the ongoing public debate, basic economic principles are often ignored: Prices in the United States are almost never determined by a product’s or service’s input costs. (The exception for this would be some commodities and highly regulated utilities like water and electricity – but I suspect not cable TV.) Rather, prices – particularly for research intensive products – are determined by fallible humans who model what markets will bear and how intersecting curves and equations parse out an answer for how to maximize short and long-term profits from a new product. This is sometimes referred to as the Net Present Value (NPV), which tries to capture the value of the product taking into account the expected changes in sales and price going forward along with the expected inflation rate and costs associated with production and sales etc. Those calculations include the expected effective life of the product in the market due to replacement by better versions (e.g., computers or cell phones), patent expiration, or, in the case of something unusual like new medicines that can cure chronic hepatitis C infections, the rapid decline in the number of people with the disease.[ii]

Those calculations for biopharmaceuticals are further complicated by the reality that there is no single price for a medicine in the U.S. where legally required discounts to government programs interacts with private sector rebates and reductions.  In addition, projected global prices – which may be linked to one another in various ways – must also be considered along with the volume of sales in various countries and regions.

So how is a “price” for “what the market will bear” determined? The calculations leading to a general range for this price (a.k.a. “list price”) includes:

  • How the condition is currently being treated or cured, and the price of those treatments (both pharmaceutical and non-pharmaceutical such as surgery), not only for an individual but for successfully treating one person in a population?[iii];
  • What other treatments and complications will be avoided, reduced, or encountreed with the new treatment?;
  • How many people are expected to use the new treatment?; and
  • The seriousness of the condition and how it impacts the lives of people, i.e., is it fatal or not? Does it seriously compromising their quality of life? etc.

All those factors (and others) are included in a description of “what is the value of the new treatment?”  That is, the greater the value (particularly compared to other treatment options) the greater the price for a course of treatment because competition between different treatment options does occur – it is just a particularly challenging assessment since it likely includes many personal issues and preferences related to both biology as well as life circumstances. In addition, because of Federal laws that limit price increases after launch, the initial prices for new medicines may be pushed to the higher end of the range described above.

The Good News, Bad News, Good News – and Other Good News Looking Forward

The good news for the health system is that as more targeted medicines with higher success rates are developed for smaller populations, the total cost is probably no more than if the medicine had been priced lower but used by more people – many of whom would have found it ineffective.  The corollary good news is that those new medicines are improving and saving lives. (If that wasn’t the ultimate reason for the spending billions and billions on biomedical research, then someone please tell me what it was.) The bad news is that because of the decades of investment in biomedical research, more and more of these new medicines are being developed and approved by the FDA – and the cumulative cost of those new medicines is increasing at a rapid rate compared to overall spending on healthcare and other medicines.[iv]

The other good news is that the increase in spending on healthcare overall has slowed dramatically in recent years, as has spending on medicines in general, which is not surprising since now more than 80% of medicines dispensed are generics. And the ongoing good news is that our imperfect healthcare system is working: As new medicines are approved they compete with their innovative predecessors for market share and on price. (An example of this for chronic hepatitis C started in late 2014 with the introduction of a new multi-pill regimen.)

Similarly, other good news (sort of) is that there is now a regulatory pathway being developed for approving biosimilar medicines that will compete with innovator biologics, which represent a large portion of the so-called specialty drugs.  The reason this is only sort of good news is that biosimilar medicines will likely cost 70-80% of the price of the original biologic medicine because biologics are expensive to produce since they are grown in living cells rather than chemically synthesized.

More good news looking forward is that biomedical science is still progressing and the future will likely see better and simpler medicines that will be higher value for patients and society.  Some of that value will be in better quality lives for people, and some of that value will be in reduced spending for other healthcare and related services. For example, a medicine that halted progression of Alzheimer’s disease – or any of the other neurodegenerative diseases such as Parkinson’s, ALS, or MS – (or prevented it from occurring, or cured it) would likely be expensive on a per person basis, but it would prevent the need for many other healthcare services, e.g., other medicines with limited effectiveness, services such as physical therapy, medical devices for physical assistance, and nursing and home care. (An historical example of this was how the polio vaccine dramatically reduced expected acute and long-term care costs.)

In addition, while biosimilar medicines are expected to be only 20-30% less expensive than the original biologic medicine, scientists are working on developing small molecule pill-type medicines that are targeted like biologics. (This is already happening for some conditions, such as certain cancers and rheumatoid arthritis, and one report indicated that over 50% of the specialty drugs in the pipeline are high-cost oral medications.[v])  While those targeted pill type medicines are expensive, because they are small molecule medicines, generic forms will eventually be available, which will be 80-90+% less expensive than the original medicine, i.e., significantly less than biosimilar medicines.  And of course, oral medicines have less delivery costs compared to injections or infusions – which sometimes require visits to a doctor’s office of clinic. So even if the patient can inject the medicine themselves, a pill also makes taking the medicine easier and eliminates the cost and hassle of disposing of used needles and other materials involved with the injection.  (Reducing the hassle – and pain – associated injections may also increase patients’ adherence to the medicine and thus increase its effectiveness.)

However, with the advancement of good news also comes some bad news. For example, with the new hepatitis C treatments, there are some people and programs that are initially in a no-win situation – and this is most clearly seen with people with chronic hepatitis C who are in jails and prisons. These individuals have a right to medical care, the rate of chronic hepatitis C infection in this population is very high (15-20%), and the risk of transmission from one person to another is higher than average (as is the risk of reinfection if someone is successfully cured). All those factors make strong clinical and public health arguments for rapid and universal treatment for all infected individuals in any non-short term corrections populations – as well as treatment for new inmates with chronic hepatitis C.  However, corrections organizations have limited and generally fixed budgets making the provision of this care for all the individuals in their facilities over a short time period a fiscal tsunami.

Corrections facilities that are privately run under contract with state and local governments face a particular challenge because, unlike government owned and operated corrections facilities, they are unable to negotiate much lower prices for the new hepatitis C treatments since those discounts wouldn trigger automatic price reductions for state Medicaid (and other ) programs that have legislatively proscribed best price requirements. This means that state and local governments that have contracted out the operations of their corrections’ medical facilities may actually be facing higher costs in the future – at least for medical care for the inmates.

Generating More Good News for the Future

The general relationship between how we pay for medicines today and what treatments and cures we end up with tomorrow is also often missing from debates and analyses of biopharmaceutical costs and treatments.  Below is a simple graphic illustrating some of those relationships.

Incentives for Innovation - (c) HealthPolCom. Blog

Appreciating these factors is important as we seek to translate basic research into new treatments, and is particularly salient because of the current situation with Ebola treatments – or the lack of them. Specifically, Ebola hasn’t been an illness in a geographic region where there has been extensive access to medical care or doctors, or a way for the people affected to pay for those treatments. (Bottom two items in the top portion of the graphic). Thus, until Ebola became a global and first-world health concern, there has been very low financial incentives for anyone (government or industry) to invest in discovering or developing new/better treatments for Ebola. (Third item in the bottom portion of the graphic).

Conclusions

  1. Specialty drugs should be called what they are: expensive medicines, treatments or cures.  Giving them a group name implies that they have some unique or differentiating characteristic – aside from price or cost – particularly with a word root indicating that these medicines are somehow “special.”
  2. Healthcare is complicated. Biomedical science is complicated. Healthcare economics is complicated – particularly when many health plans have five (or more) cost-sharing tiers for medicines.
  3. Biomedical research has produced some incredibly effective new treatments. (Thank you!) However, there are still many serious, chronic, and life-threatening illnesses with few (or zero) good treatment options.
  4. Prices and value in healthcare are as complicated concepts as biomedical science. And value assessments almost always involve personal factors. For example, would Steve Jobs have paid $1 billion for a cure for his pancreatic cancer? I think so.
  5. Society has invested billions in biomedical research and development (probably close to a Trillion dollars over the past 20 years), and received significant benefits. The ongoing challenge is how to maximize those and future benefits by making difficult financial, resource, clinical, and ethical decisions within our imperfect healthcare system run by fallible biological beings.

 

 

p.s. Sorry for the long post.


[i] “Specialty Medications: Traditional and Novel Tools Can Address Rising Spending on These Costly Drugs,” Lotvin et al., Health Affairs 33, No. 10 (2014) 1736-1744.

[ii] A similar situation happened in the early 1990s with the introduction of new flexible lenses for cataract surgery.  There was a tremendous upswing in the number of operations, which cost Medicare much more than expected, due to pent up demand. And after that surge, the number of people getting cataract surgery (and the costs) dropped to a much lower steady state – although one that continued to increase at a small growth rate because of the aging demographics in the U.S.

[iii] For example, if a new treatment successfully treats 50% of people with a serous condition, and the older treatment only successfully treats 10%, the clinical value would be 5-times as great, which would also translate into an economic value that is multiple times the older treatment. Other factors that would affect the value would be the route of administration, side effects, and other services and products required or avoided with the new treatment.

[iv] Studies have estimated that per year spending growth for non-specialty medicines is now less than 4% range, while annual spending for “specialty” medicines is growing in the 10-15% range.

[v] “The Growth of Specialty Pharmacy: Current trends and future opportunities, “ UnitedHealth Center for Health Reform & Modernization, Issue Brief, April 2014, citing: Atheer Kaddis and Stephen Cichy, “Payer Tactics to Manage High-Cost Specialty Drugs in the Pipeline,” AIS Webinar – Specialty Pharmaceuticals, September 2013.

Sovaldi® and Curing Hep C – Myths and Other Facts

The introduction of new oral medicines that can cure chronic hepatitis C infections (including Sovaldi®) have led to some intense discussions permeated with misleading information about the pricing of new medicines, how such medicines are “game changers,” and the implications for budget-crunched payers.  Below I summarize some key points about those issues.

1.  Myth #1: How Medicines are Priced

One of the perpetuating myths about biopharmaceuticals is that medicines are priced to recoup research and development costs.1 It’s a myth. As I’ve written about elsewhere prescription medicine prices are set like everything else in a regulated free market: Companies set prices to maximize revenues and profits based upon the market opportunities and the value the new medicine provide compared to the consequences of the disease and other treatment options – including no treatment at all.  (See more about this in #4 below.)

2.  Myth #2: There is A Price

While the price of Sovaldi® has been widely written about in the press, in reality, there is no single price in the U.S. for almost all medicines. Rather, every medicine has a range of prices that include the discounts required by law to Medicaid, VA, DoD and other government programs, and the discounts negotiated by private insurance companies. The widely reported price of Sovaldi®, which is the starting point for those discounted prices, has been widely criticized, but a high-level examination of the situation illuminates a relatively logical picture as discussed below. Furthermore, an understanding of the overall situation with chronic hepatitis C infection and those new medicines leads to a reasonable strategic framework for payers facing significant costs for treating people with chronic hepatitis C infection.

3.  Situation with Chronic Hepatitis C Infection

A.  Most of the roughly 4 million people with chronic hepatitis C in the U.S. were infected before 1992 when a test to screen donated blood started to be used.

B.  Today, the rate of new infections is about 45,000 people per year, and those infections are acquired primarily through intravenous drug use.

C.  The older treatments for chronic hepatitis C infection largely depended on activating the patient’s immune system to clear the virus from the body, which is why the medicines in those treatment regimens, (e.g., interferon) make people feel like they have a bad flu for several/many months.

D.  Assuming patients can tolerate the side-effects and complete their course of therapy, the older treatments for hepatitis C had cure rates2 as low as 20% depending on the strain (genotype) of the virus and certain patient characteristics.

E.  The new medicines for chronic hepatitis C infection are “game changers” since they have reported cure rates of 90-95+%. Ray Chung, MD, a hepatitis C expert, has described these new medicines as a clinical paradigm shift from treating a liver disease to curing hepatitis C infection.

F.  These medicines are also “game changers” because this is the first time biomedical science on earth has developed a cure for a chronic viral infection. (I can’t speak for other planets, galaxies, or other spatial dimensions.)

G.  The low rate of new infections in the U.S. means that if people currently infected with hepatitis C are treated and cured (and the new medicines seem capable of curing people by eliminating the virus from their bodies), then – in theory – hepatitis C infections could be eliminated, or at least driven down to very low numbers.

H.  Physicians (particularly gastroenterologists and hepatologists) were aware that new – and much better – medicines to treat (and hopefully cure) hepatitis C infections were expected to be approved in late 2013/early 2014. Therefore, many patients weren’t started on the older therapeutic regimens that had significant toxicities and low cure rates.

I.  The people who deferred treatment in 2013 were lined up to be treated in early 2014, and this produced a large wave of new patients (and sales) for the new medicines in early 2014.

4.  Rationale for Pricing of Hepatitis C Cures

I stated above that companies price new medicines to maximize revenues and profits.  That’s only sort of true. New medicines are really priced to maximize the value the company will get from selling the medicine over the entire effective life of the product.  Economists refer to this as the “Net Present Value” (or NPV), which takes into account expected revenue in future years, discounted by how much less a dollar in the future will be worth than it is today because of inflation, and other factors such as competition from other treatment options. For Sovaldi® the most significant factors are competition and substitution due to other medicines expected to be approved in 2015 and beyond, AND the limited number of people with chronic hepatitis C infection.

The relatively finite pool of patients means that NPV calculations for Sovaldi® do not look like other medicines to treat chronic diseases or to keep cancers in remission, because those types of medicines have large (and probably growing) patient populations that will be taking those medicines on an ongoing basis. Therefore, the “value” of Sovaldi® in the latter years of its 14-year effective patent life3 will be much, much, much less compared to those other medicines. This front-loaded fiscal/value situation means that setting a ceiling price at the higher-end of the comparable range for treatments for a serious illness that will be taken as a single course for a shrinking population is a logical outcome.

5.  Path Forward for Budget-Crunched Payers

Because Medicaid programs, the VA, and state/local prison systems have significant numbers of people with chronic hepatitis C infection – and they have fixed or semi-fixed budgets – treating everyone infected with hepatitis C all at once would be a significant budget buster. Below I describe a framework for logically approaching this situation.

But first, it is also important to recognize some other factors about chronic hepatitis C infections and Sovaldi® and other medicines that are expected to be approved to treat/cure hepatitis C in the coming months/years:

A.  Of the estimated 4 million people in the U.S. with chronic hepatitis C infection, most do not have significant liver disease characterized by changes in the structure and function of the liver that ranges from various degrees of fibrosis and cirrhosis to full liver failure or liver cancer.

B.  People with more advanced disease are already costing the health system significant amounts and have the most health and quality of life problems.

C.  While the exact percentage of people with chronic hepatitis C who have advanced disease is unknown, a reasonable guess might be about 20-30%.

D.  People who do not have advanced disease will most likely progress to advanced disease, and there are known risk factors that increase the likelihood of more rapid progression.

Given those factors, a reasonable approach for payers with limited resources would be to put those people with advanced disease in the front of the queue for the cure. Other people who should be included in this “first to treat” group would be individuals who have certain criteria that increase their risk for rapid progression of liver problems, or are having health problems from the infection outside the liver (i.e., extra-hepatic manifestations) such as renal, hematologic or rheumatologic problems, or are symptomatic.

Other groups that could be considered for priority treatment could include people in prisons (or being released from prisons) who might be at increased risk of transmitting the virus to others.  (People who are cured of their chronic hepatitis C infection can be reinfected.)

After this first group’s treatment is addressed, the next group of individuals with risk factors for more rapid progression to advanced disease (such as longer time since their estimated date of infection) could be eligible for treatment.

This “triaging” of priorities would spread costs out over a longer period of time in a rational way. In addition, because of real-world barriers to identifying and engaging all potential patients, not all the people in those first to treat categories would get treated in the first few months or year. Therefore, the actual first year costs would be below the results from a simple calculation of the number of people multiplied by the treatment costs per person.

Such triaging would give budget-crunched payers time to plan for future budget years with the realization that the number of people with chronic hepatitis C infection will be decreasing over time.  After a few years of treating people with chronic hepatitis C infection (depending on how the triaging/staging is done, along with the effectiveness of public health outreach and screening) the annual costs for medicines for people with chronic hepatitis C infections should become relatively low even before generic versions of the new medicines are available.

6.  Cures for Chronic Hepatitis C Infection Are Not Game Changer

Some people have angsted about how the new treatments for chronic hepatitis C are harbingers of more expensive, budget-busting medicines. However, looking at the pharmaceutical industry pipeline, there are not medicines in clinical development to cure other chronic viral diseases.  Nor are there medicines to cure other serious chronic diseases.  I certainly wish there was a $100,000 cure for MS, Parkinson’s, Alzheimer’s, ALS, HIV/AIDS, or many other debilitating or degenerative conditions – but there aren’t, and there don’t seem to be any on the near horizon. Thankfully, there are compounds in clinical trials to better treat those conditions by preventing or slowing progression, as has already happened for rheumatoid arthritis and some other autoimmune diseases. Therefore, while the new cures for chronic hepatitis C are game changers for people with that specific condition, unfortunately, cures for other serious chronic illnesses do not appear like they will be available very soon.

7.  Caveats & Other Notes

I apologize for this rather lengthy post – particularly after the long time since my last post.  But there are a few other points to note:

  • These thoughts are my own, nobody has paid me to write this, and only one person reviewed it for gross factual correctness.
  • My projections and estimates of infection and cure rates etc. are derived from conversations with knowledgeable people and reading the literature, but there is clearly a significant level of uncertainty about many of those estimates, including the numbers of people infected and their stages of disease.
  • Even the best projections are off by some significant percentages.
  • The price of other medicines for chronic hepatitis C infection that are expected to be approved in the next 6-36 months are unknown, but the price range for Sovaldi® should set an upper limit based on a course of treatment to achieve a cure. Therefore, for example, if another compound is approved that achieves a similar cure rate with similar side-effects, etc., but only needs to be taken once a week for 8 weeks (i.e. 8 pills), it would likely have a higher per pill price than Sovaldi®, but a lower total cost for a course of treatment.

 Footnotes:

  1. While, the risk of biopharmaceutical R&D is borne by companies, they cannot bake the R&D costs of individual medicines (and dead ends) into the prices of those medicines.  Rather, a company’s profits are the source of funds for future R&D. Specifically, companies makes decisions about how to use their financial resources (primarily derived from profits) for R&D and other activities. R&D opportunities are evaluated based upon the projected market potential combined with the company’s expertise and capabilities that would enable the company to successfully develop a new medicine in a specific disease area of need, i.e., where there is a market opportunity.
  2. Cure is defined as no detectable virus six months after the conclusion of treatment.
  3. http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=204671&Product_No=001&table1=OB_Rx

CER, HIT, and Women’s Health Research

Below is a video of my discussion with Phyllis Greenberger, President and CEO of the Society for Women’s Health Research, about the implications of comparative effectiveness research (CER) and information technology for women’s health and quality improvement.

What are your thoughts about CER and HIT?  Will they lead to higher quality, lower cost, or more efficient/better healthcare?  And if so, how soon?


FYI – The SWHR’s July 18-19 meeting mentioned in the video is “What a Difference an X Makes: The State of Women’s Health Research.”

Jimmy Buffett Medicare and Healthcare

The title of Jimmy Buffett’s song “Changes in Latitudes, Changes in Attitudes” is a good description of the fundamental changes occurring in the US healthcare system:  Within the Federal Government – and Medicare in particular – widespread “Changes in Latitudes, Changes in Attitudes” are evident in the implementation of the Affordable Care and HITECH Acts, and the overall leadership of the Department of Health and Human Services.  Healthcare leaders in private organizations – and state and local governments – are embracing these changes, which collectively are leading to better healthcare quality and lower costs…. Or at least slower increases in healthcare costs, a.k.a. a bending of the healthcare cost curve.

Changes in Attitude

Traditionally government programs have worked at a long-arms distance from private companies and organizations.  For Medicare, this has meant that changes in rules and regulations were conveyed to healthcare providers and clinicians by publishing them in the Federal Register or as updates to the manuals used by Medicare’s bill-paying contractors. Private payers, (e.g. insurance companies), responded to these changes and updates because Medicare is the largest single payer for healthcare services. Providers and clinicians were thus always responding to a shifting quilt of payment rules and provisions – and more recently an additional layer of quality reporting requirements.

CMS and HHS have repositioned the government’s payment practices to serve an aligning leadership role that is minimizing confusion and complexity for providers and clinicians, while also promoting greater transparency and accountability. The government has accomplishing this by working with private payers (to the extent allowable by sunshine and antitrust laws) to give providers and clinicians more consistent guidance on payment policies and quality metrics, as well as incentives for improving the organization and delivery of care.  An example of this is the Comprehensive Primary Care Initiative (CPCI). The goal of this program is to promote higher quality patient-centric primary care. To determine the CPCI locations, CMS used a bidding process where the seven winning regions were those that committed the highest concentration of insured people, i.e., a combination of private payer, Medicaid, and Medicare covered lives. All the payers in the selected locations agreed to work collaboratively to identify the primary care practices that would get incentive payments for improving the quality and the integration of care – with each payer determining the specific level of financial incentives and support for each of their covered lives in these practices.

The key facets for the CPCI program are:

  • Public and private sector payers are truly aligned for comprehensive healthcare transformation.
  • It is using market forces to promote this transformation.
  • It is a community based initiative that is engaging local leaders, and which requires their buy-in and shared ownership of the process and the outcome.
  • It is structured to seek both quality improvements and costs savings.

Other initiatives from the ACA-created CMS Innovation Center are seeking to partner Medicare with local providers and payers for payment mechanisms that will promote better quality and lower costs, i.e. higher value healthcare that achieves the improvements that people and communities want.  Some of these programs involve bundling of payments around certain conditions, and the Innovation Center has explicitly stated a desire to consider providers’ ideas for new models of care and financing outside of the matrix of models it has already proposed.  (It is doing this through Health Care Innovation Awards.)

At the same time, “regular” Medicare is shifting its attitude about poor quality care. For example, last fall new Medicare rules became effective that prohibit hospitals from receiving a second payment from Medicare if a patient with pneumonia, congestive heart failure, or after a heart attack is readmitted to a hospital within 30 days, i.e. a return to the hospital that is preventable with good post-discharge care coordination and follow-up. This is just one of many new financial incentives – both positive and negative – involving actual quality of care that Medicare is moving forward with based upon various provisions of the ACA. (Private payers are implementing similar quality of care related payment policies.)

Changes in Latitude

While Jimmy Buffet was talking about geographic lines of latitudes, Medicare and HHS have exhibited changes in latitude for the requirements placed on many healthcare providers and clinicians – particularly those participating in programs designed to deliver higher quality care.  In addition to the Innovation Center examples cited above, Medicare’s new Shared Savings Program enables Accountable Care Organizations (ACO) to be structured in a wide variety of ways as long as they meet certain requirements and commitments.  And one area where they are permitted full autonomy is how an ACO distributes any shared savings (or other financial incentives) to the healthcare professionals and provider groups within or connected to the ACO.  While Medicare wants to be informed about these internal incentive structures – presumably to guide the development of future value-promoting programs – Medicare is not dictating this crucial facet of an ACO’s operations.

This attitude for considering such wide latitude of ideas illustrates the sea-change shift that has occurred within the government bureaucracy that has traditionally sought to evaluate “new ideas” primarily by comparing differences in existing care delivery models across the spectrum of the US healthcare system. However, CMS’ Innovation Center does not have full autonomy for conducting Medicare demonstration projects since it is required to focus on new models for paying healthcare providers, e.g., doctors and hospitals.  Because of this limitation (and related anti-kickback laws) the Innovation Center cannot do demonstrations that alter benefit structures, or empower ACOs to create new financial incentives for patients by changing co-payments or other cost sharing requirements. In contrast, private payers are implementing financial incentives to prompt patients to use certain providers, select primary care physicians to help guide them through complex care situations, or adhere to medical therapies for chronic conditions, etc. Perhaps in the future, (either directly or as part of the latitude for accountable healthcare systems), Medicare will be able to test modifications of beneficiaries’ cost-sharing to expand how patients are engaged for improving the quality of care and sharing cost savings.

Storms Ahead

While the changes occurring within CMS, private payers, and healthcare deliver organizations across the country are very exciting and have great potential, not every initiative or transformation will be 100% successful.  This is to be expected, and it will present the opportunity to learn from whatever shortfalls occur – as well as organizations that exceed expectations.  This knowledge will be important for creating new initiatives and modifying existing ones as they move forward.  Hopefully, other organizations committed to improving care and lowering costs in the public’s interest will be on board with CMS’ new attitude, support the inevitable challenges that law ahead, and seek to calm the waters of public discourse rather than whip the storms like Thor.

Accomplishments v. Activity in Healthcare

The phrase “Paying for Value not Volume” has been health reform’s mantra for several/many years.  But the concepts embodied in “Paying for Value not Volume” are problematic on two levels.  First, the term “Value not Volume” doesn’t convey a clear picture of the specific changes health reform is trying to achieve. This creates problems communicating the benefits of health reform and healthcare transformation to people who are not steeped in health policy, including most clinicians and patients.

And second, the “Paying for” part of the phrase indicates that the focus is on financial reforms. This creates a barrier to people (i.e., patients) embracing the underlying principles of “Value not Volume” because, from their perspective, changing how doctors and hospitals are paid seems unlikely to benefit them – and could potentially harm them by decreasing access or increasing their costs.  In addition, “Paying for Value not Volume” seems disconnected from the important access and clinical improvements that people care about as much as they care about cost control – if not more so.

Accomplishments Trumps Value
Therefore, rather than “Value not Volume” a better phrase would be “Accomplishments not Activity.” This phrase more directly represents what people and society really want from health reform, i.e. accomplishments in the form of better clinical and economic outcomes.

While it could be argued that “Value” captures the same intent as “Accomplishments,” “Value” is more ambiguous and less specific. For example, employees are often paid partially on the value they deliver for their company, but the specific factors used to determine that “value” are quantifiable measures such as sales or actions that produce revenue generating goods or services.

Thus, paying for healthcare accomplishments is a simpler and more direct concept. It avoids the rhetorical and cognitive extra step of translating “value” into specific accomplishments. In addition, the concept of paying for accomplishments could also include incentivizing patients for specific achievements related to improving their health or reducing their risk of illness.  In this way, “Paying for Accomplishments” is a broader term than “Paying for Value” because it connects innovations in provider and clinician payments to the expanding array of new provisions health insurance plans are adopting to motivate and help individuals achieve certain wellness goals, e.g., smoking cessation classes, weight loss incentives, etc.

Goals of Health Reform
Similarly, “Achieving Accomplishments” could be a good phrase for describing the goals of health reform, e.g., “The goal of health reform is to achieve accomplishments in three areas: improving health for populations, improving health care quality, and lowering health costs. And the accomplishments we expect to achieve this year for our [community, region, state, country] are……”

Conclusion
“Accomplishments not Activity” is a term that people can more easily understand, and this greater understanding could help the public embrace innovative payment models and insurance plan designs that – by rewarding accomplishments – are creating linked incentives for providers, clinicians, patients, and communities to collaboratively build higher performing healthcare delivery systems.

Cutting Employer Healthcare Costs

Over the past 20+ years larger companies have tried many tactics to control the growth of their healthcare spending, including HMOs, consumer-directed healthcare, wellness programs, value-based insurance design, selective contracting for high-cost procedures, personal health assessments, etc.  While some of those efforts temporarily reduced employers’ healthcare spending, they did not change the long-term trends, in part because they only targeted employees and did not focus on high or very high cost individuals – many of whom are not active workers. [A recent Health Affairs article analyzing conditions associated with employee healthcare spending reflects this “searching under the streetlamp” phenomenon.]

Company Health Benefit Costs Do Not Equal Employees’ Healthcare Spending

The cost of providing health benefits for most larger companies includes not only the health benefits for employees, but also costs for retirees, and spouses and dependents of active workers. In addition, these “other” groups represent a disproportionate amount of health benefits costs because they are generally older and/or in poorer health. The importance of this factor is depicted in the chart below that illustrates how healthcare spending is not uniform across a group of people, e.g., all the individuals covered by a company’s health plan, or Medicare beneficiaries. While the actual spending per person changes significantly depending on the specific group, the general shape of the curve remains the same with about 5-10% of the people accounting for 20-40% of all the spending. For companies’ health benefit programs – as mentioned above – retirees, spouses and dependents make up a disproportionate share of individuals in the yellow and red zones.


[Y-Axis = Percentage of spending;  X-Axis = Percentage of people in the group]

In addition, these high cost individuals are also the people who have the most complicated (and usually chronic) healthcare problems, and thus whose healthcare quality and health status can be improved the most.

Challenges in Targeting High Cost Individuals

Companies have typically focused health improvement and wellness initiatives on active workers because they were the individuals the company had the greatest direct interaction with, i.e., they were the people seen in the workplace. This situation reflects the analogy about potential analytical biases where a person will search for dropped keys under the streetlight because that is the only visible area, i.e. information about what is outside the arc of the streetlight is unavailable.*

[Source: “Fixing the US Healthcare System,” 2008 – Unpublished]

While some employers are starting to focus initiatives on high and very high cost individuals, they face several challenges in creating and implementing these programs.  For example, since these individuals are more likely to be spouses, dependents or retirees under the age of 65, it can be more difficult for companies to reach them.  Other challenges that companies’ health benefits programs face in interacting more closely with these people are:

  • HIPAA privacy concerns.
  • For retirees under the age of 65, expecting that they will soon by on Medicare, and thus the company may not see any economic benefits.
  • Lack of potential benefits to the company by improving health and productivity for people who are not active workers. (However, improving the health of high cost dependents and spouses of active workers can reduce the employees’ absenteeism by decreasing the time they spend providing caregiving and care-assisting help to their family members.)

How to Improve Health Delivery and Control Spending for High Cost Individuals

Controlling healthcare spending for high cost people is not easy, nor is it inexpensive. Actions to control spending for these individuals generally involves making care more efficient and reducing errors and complications – which also improves the individual’s health status, i.e. it is a Win-Win situation with improved clinical and economic outcomes.

Specific actions to control spending for high cost individuals includes initiatives such as:

  • Case management e.g., nurse case management and/or tele-medicine
  • Team based care e.g., patient-centered medical homes
  • Integrated care e.g., quality monitoring and fiscal incentives for quality and economic performance

The common theme among these actions is that they are all designed to ensure that nothing falls through the cracks leading to very expensive cascades of poor clinical outcomes and complications. An additional benefit is that these initiatives can also help direct care for people with costly chronic conditions towards the places/locations/providers that are more efficient and higher quality – and often less costly. (Some companies are doing this for elective surgeries, and incentivizing individuals to use specified providers by offering reduced or zero cost sharing, as well as paying their travel costs.)

Does Better Care for High Cost Individuals Pay Dividends?

Financial calculations can quantify the direct value of these efforts. For example if high and very high cost individuals are costing the company more than $10,000 or $25,000 per year, an investment of $1,000, (such as for intensive case management), that reduces spending by 10% provides at least a break-even ROI.  Spending reductions of this magnitude are very achievable for people with complicated diabetes or congestive heart failure. And some healthcare innovations have been shown to reduce spending by 20-30% for people with those conditions. However, not all “case management” or “disease management” programs are the same. As a general rule, “you get what you pay for,” i.e., programs that are less expensive and/or not integrated into the patient’s healthcare team-flow, tend to not benefit individuals with serious chronic illnesses – or deliver a positive ROI. (This was evident in the Medicare Case Management Demo I referenced in a 2009 article on this blog.)

Of course, not all people who fall into the high cost category can have their spending easily controlled through better case management or integrated team-based care. Thus, companies will not see a positive ROI through better healthcare management for all high cost individuals. Some diseases and conditions are just unexpected, inherently expensive, or have long lag times before positive benefits are seen. For example, cancer rates (and spending) can be reduced through exercise, nutrient and smoking cessation – as well as early detection – but the timeframe for those improvements can be long.

Accidents outside the workplace are also frequently cited as high cost medical cases that cannot be prevented. However, alcohol (or abuse of other substances) and/or mental health conditions are often contributing factors for accidents – factors which can be addressed through the healthcare system.  Unfortunately, because of the fuzziness of the ROI calculations, privacy issues, or other concerns, these areas have not generally been a focus for employers.  In addition, in some professions, these medical problems can lead to loss of employment or advancement opportunities, making them especially difficult to address as part of a person’s comprehensive medical care.

Identifying High Cost Cases

Before value-producing interventions can help high cost individuals, these people need to be identified so that they can be engaged to participate in these programs. Fortunately, there are increasingly sophisticated and efficient ways to identify high cost people:

  • Claims analysis conducted by the employer’s insurance company.  (Having the insurance company analyze the claims data creates an important information firewall to address HIPAA privacy concerns. Because of privacy issues, an insurance company – or managed care company – is also in a better position to directly contact and engage individuals for participation in any programs.)
  • EMR database analysis by individual health systems or large provider groups.
  • Asking physicians to identify their medically fragile and high utilizing patients, and then engaging/enrolling them in the appropriate care management programs.  (However, this approach works best for community-wide initiatives rather than individual employer populations since it could be inefficient and unusual for physicians to separately analyze or engage their patients by employer.)

Preventing High Cost Situations

A related set of challenges is identifying people who are not yet high cost individuals, but are sliding toward that end of the scale, (e.g., pre-diabetes, unrecognized diabetes, high blood pressure, smokers, etc.), and preventing them from becoming high cost cases. Some individuals may be easy to identify, (particularly with a high quality EMR system that can do practice-wide analyses), but changing an individual’s potential healthcare trajectory is hard. Changing community norms and expectations for smoking, exercise, and nutrition can be effective foundational actions – and are good initiatives for reaching non-workers such as retirees and spouses.  However, changing personal behaviors on a shorter time frame generally requires one-on-one engagement and encouragement.  This can start with the person’s medical care team, with a non-physician clinician, (such as a diabetic educator, nurse specialist, or health coach), who can provide on-going support as well as referrals to services and resources in the community through organizations such as the YMCA.

Conclusions

Controlling the long term growth of the cost of employers’ health benefits programs, (i.e., bending the “cost curve”), requires focusing on individuals who are costing the most, as well as preventing individuals who are smoldering with early-stage or unrecognized conditions from exploding into expensive complex chronic disease situations.  For self-insured companies, investing in disease and case management programs, tools, and services requires resources, spine, and compassion, but the financial and human-value returns (including company loyalty and appreciation) can be significant. Few smaller companies can marshal the time and resources for these programs, but as technology improves and health insurance markets become more efficient, these services should become more readily available through purchased insurance products – including those offered through the ACA created state-based insurance exchanges.  This should happen with the next 2-5 years since, “it’s where the money is.”

 

* The parable about looking for lost keys on a street at night illustrates the pitfalls of operating with limited information while trying to solve a problem.  The tendency is to look under the streetlights because that is the only place where you can easily see, i.e., this is where there is easy access to the “data” about what is on the ground to see if the keys are there or not. However, it is also possible that the keys are outside of the corona of the streetlights.  But looking outside those circles takes both imagination to realize that the street exists outside the circles of light, having access to data about what lies outside the circle of light, (possibly with “technology” such as a flashlight), and making the effort to seek and understand this “new” data. [Source: “Fixing the US Healthcare System,” 2008 – Unpublished]

Doctors are Not Terrorists, But…….

Changing behavior is very complex.  Many management books, philosophical tomes, and academic psychology articles have been written on this subject, so I’m going to simply and quickly get to the connections among doctors, terrorists, and health reform.

1. Changing people’s behavior requires appealing to basic motivating factors. Different individuals have different motivators, but everyone has them.

2. Physicians are a key part of the healthcare system.  Improving quality and controlling healthcare spending will require physicians to do some things differently – particularly how they work with other clinicians (i.e., in teams), prescribe treatments, order tests, make referrals, and interact with patients and their families.  (Physicians receive about 20 cents of every healthcare dollar, but control about 80 cents. And an old axiom is that the most expensive piece of medical equipment is a pen in a physician’s hand – although soon it may be their hands on a keyboard.)

3. Money is a key motivator for many people…. But it’s not the only one. For many clinical thought-leaders and decision-makers, money may be of secondary concern.

Physicians, and Terrorists, and Everyone are Motivated By Specific Factors
I’ve long believed that aligning non-financial motivators is crucial for successful health reform because success will require changing individual attitudes and actions. But I didn’t realize how broadly powerful non-financial influencing factors could be until I read “Counterstrike,” the recent book by Pulitzer Prize winning journalist Eric Schmitt and his co-author Thom Shanker. This book describes how, in the mid-2000s, US anti-terrorism organizations saw markedly greater success by shifting their strategy from prioritizing “find-capture-kill” operations to taking actions that pivot potential terrorists’ motivational forces – in part by similarly pivoting the support potential terrorists receive from their families, communities, and religious leaders.  Some of these non-financial factors are:

  • Personal reputation
  • Personal glory
  • Network cohesion and dependability
  • Well-being of their family

As can be seen from this list, some of the factors that influence terrorists are similar to what could also motivate physicians, i.e. professional recognition, influence within their organizations, community status, etc.

Desired Outcomes
The face of successful health reform will be physicians enthusiastically doing things differently because they recognize that their actions are making their patients and communities healthier, making their own lives better, and also easing the “economic dragooning” that the healthcare system was imposing on society.

Successful Health Reform = Changing Physician Behaviors
Achieving these outcomes will depend upon changing physician behaviors, as described in #2 above. And while financial incentives* supporting those behavior changes are being incorporated into new delivery models – such as Medical Homes and Accountable Care Organizations – the organizations that successfully build these new models will utilize other motivating factors in their quest for higher quality, lower costs, and better care experiences for both physicians and patients.  As I noted in the opening paragraph, many pages have been written on changing behaviors, but the fundamental elements were described in general terms by Everett Rogers in his book, “Adoption of Innovation”:

  1. Relative Advantage
  2. Compatibility (with existing or connected practices and actions)
  3. Simplicity
  4. Observability
  5. Trialability

These principles are important because changing behaviors is synonymous with adopting innovations, e.g., using an ATM rather than a bank teller, writing on a computer rather than a typewriter, inhaling insulin** rather than injecting it. And thus, achieving successful behavior changes and producing our desired three aims will require change leaders to incorporate these elements – and both financial and non-financial factors – into their strategies for motivating physicians, patients, and all groups who make up the healthcare system.

 

*These incentives are generally described as rewarding value and quality rather than volume of services, and include pay-for-performance, shared savings/risk, bundled payments, and capitation.

** Not all innovations are successful – at least in their first iteration.

Why Healthcare Spending is Slowing – A New Normal?

The growth in healthcare spending has slowed in recent years.  Many experts and pundits have sought to explain why – while also worrying, (or predicting), that this slowing is only temporary, i.e. past performance will predict the future.

Healthcare Delivery and Financing are Dynamically Evolving

The future will be significantly different than the past because our healthcare system, society, and economy are evolving into what might be called a “New Normal” state.  Assuming current priorities and pressures continue, public and private sector organizations at all levels will increasingly emphasize value¹ in their decisions about spending and preferences for healthcare services – including choices about substituting one treatment option for another.  For public entities, these choices involve coverage and budgeting for programs ranging from Medicare, Medicaid, and Veterans’ healthcare, to benefits for government employees – as well as rules for insurance exchanges. For private organizations, these choices range from health insurance benefits provided by large employers to the decisions individuals make for their insurance coverage – as well as the clinical and lifestyle choices individuals make inside and outside doctors’ offices.

While those choices will collectively mold our future healthcare system, many changes have occurred in the last five years that are creating a new environment for making these choices and pushing us into a “New Normal” state, i.e., these evolutionary forces have already started bending the cost/spending curve.  This progress towards more value oriented healthcare will continue unless the driving forces are hampered, hindered, or blocked by future actions.

The Times They Are a-Changin”
                             Robert Zimmerman

Listed below – in my estimated rough order of importance – are reasons why healthcare spending has slowed and will continue to be less than had been projected.

  1. Dipping Economy: The economic slowdown has decreased the amount of healthcare people are seeking – as well as creating a temporary disruptive environment for making other changes in stakeholders’ attitude and latitudes of practice. Whether the decrease in healthcare utilization is because people have mostly declined or delayed unnecessary or truly discretionary healthcare services and treatments, or are foregoing many important preventive actions and therapies – which will lead to higher costs and morbidity in the future – remains to be determined.
  2. Private Insurance Benefit Design Changes: People with private insurance have shifted to higher deductible plans², (a.k.a. consumer directed plans), which have lower monthly premiums and higher deductibles, and sometimes increased co-payments/co-insurance.  This change has been in both employer sponsored plans – where individuals may not have a choice – as well as for people (and families) buying insurance as individuals or through small business plans.  Like #1 above, economic incentives have led people to be more selective in what healthcare services and products they are using, but the wisdom of these choices and their long-term effects on costs and quality of care (and life) are not yet fully understood.
  3. Medicare Outpatient Prescription Drug Benefit: The Medicare outpatient prescription drug benefit, (a.k.a. Part D), started in 2006.  If the general premise that prescription medicines are the most clinically and cost-effective form of healthcare is correct, then the greater use of prescription medicines by Medicare enrollees should be reducing spending growth in other Parts of Medicare, e.g. hospitalizations and doctor visits.
  4. Mindset Changes for Patients and Clinicians: The economic downturn, various provisions of the Accountable Care Act, and changes in healthcare benefit design – particularly more high deductible health insurance plans – are making patients and clinicians more attuned to the economic implications of healthcare choices and the value of integrated, multidisciplinary, (a.k.a. team-based), care delivery. Resistance to shifting to such integrated care from the old one-patient/one-doctor Marcus Welby, MD-esque mindset will impede progress in some areas – particularly the adoption of EMRs and regional health information systems, which require up-front spending, and where the long-term benefits are derived from providers participating in such team-based care paradigms.
  5. Change to Healthcare Delivery System:
    1. Integrated care delivery systems and the purchase or affiliation of physicians’ practices;
    2. Geographically uneven changes;
    3. Accountable Care Organizations (ACOs);
    4. Patient Centered Medical Homes (PCMH);
    5. Concierge medical practices;
    6. Greater use of tele-medicine for remote monitoring, management, and consultations;
    7. Greater use of non-physician clinicians, community based healthcare coordinators, and home care services – including more old-fashioned house calls.
  6. Change to Financial Incentives: (Besides high-deductible insurance plans)
    1. Pay for Reporting (P4R) – usually tied to quality metrics, but also used for EMR capabilities;
    2. Pay for Performance (P4P) – similar to P4R, but for actually performance, not just reporting;
    3. Global or bundled payments, e.g. ACOs shared savings and risk sharing arrangements with Medicare and private payers;
    4. Non-payment for “never events”.
  7. Trans-Fat Labeling: FDA regulations have required food labels to list trans-fats since 2006, which has had a two-fold effect which should be driving down long-term health spending: Making people more aware of trans-fats as an unhealthy choice, and inducing food companies to both remove trans-fats from their products and advertise that fact. The results have been significant. Earlier this year the CDC reported that blood levels of trans-fats have declined from 2000 to 2009: “The 58 percent decline shows substantial progress that should help lower the risk of cardiovascular disease in adults”. I suspect that CBO or others didn’t project savings to Medicare or Medicaid from the food labeling requirement.  However, shifts to healthier lifestyles will need more environmental changes like these, e.g. bike sharing programs; walking paths; programs connecting individuals with shared goals; healthier food options at cafeterias, restaurants, and grocery stores, etc.
  8. Price Transparency and Accountability for Outcomes: More transparency about prices and quality of care delivered by individual clinicians and providers is placing greater pressure on healthcare prices. In addition, since healthcare prices in the US are higher than in other countries, globalization will increasingly create downward pricing pressure – especially for products and services where people, (or their specimens), can easily travel to other countries, such as for elective surgery, or DNA testing. [Note – accountability for quality, accuracy, and fraud prevention will be necessary to ensure that foreign services with lower prices represent higher value rather than just greater waste and harm to patients.]
  9. Innovations – Better Therapies, Diagnostics, and Prevention:
    Healthcare innovations range from biopharmaceuticals, genetic tests, HIT/tele-medicine, to validated best practices including checklists and clinical decision support.  Some innovations increase costs. Some improve clinical outcomes. Some do one but not the other. Some do both.  As metrics demonstrating the value of innovations become more granular and can be determined more rapidly, clinicians and providers will be under greater pressure to demonstrate – and be accountable for – the outcomes they are delivering. However, this will only occur in a balanced way as long at patient-centric quality outcomes are measured alongside economic outcomes.  The danger is that clinical outcomes will only be determined on a population basis, but then applied to patient care decisions without considering individual patient characteristics or priorities.
  10. Smoking Restrictions.  Restrictions on smoking in public places is reducing exposure to second-hand smoke.  Some studies have shown rapid declines in heart attacks for people working in restaurants and bars after smoking in those workplaces was prohibited.  (FYI – LEED certified residential buildings treat second-hand cigarette smoke as a pollutant and often prohibit smoking inside the entire building – including people’s apartments, as well as outside doors and windows. And the DC Department of Health has been publicizing the toxic nature of second-hand cigarette smoke from adjacent apartments.)
  11. Tougher Enforcement Against Fraud and Abuse. Cracking down on fraud and abuse may be reducing healthcare spending by deterring such criminal activity.  These efforts have been aided by improvements to healthcare IT – and this will only improve in the future.
  12. There certainly should be a 12th reason – since all good lists have 12 items – but I can’t think of one right now…. Any suggestions?

Not a Simple Picture

The dynamic interactions among many of the factors listed above makes it very difficult to determine the contribution each one makes to reducing healthcare spending for a particular condition, population, or US healthcare spending overall. For example, improvements to healthcare IT are enabling improvements to delivery system operations and financial incentives – which are also linked to each other.  Each of these also affect the mindsets of  patients and clinicians, i.e., HIT systems are elevating patients’ and clinicians’ expectations for better information about treatment options and less waste. And financial incentives are evolving to support the use of such information to achieve better outcomes. Together these and other changes are altering patients and clinicians attitudes and actions towards the entire healthcare system to be accountable for delivering greater value. This hyper-cross-connected situation is analogous to the biomedical research field of systems biology, which is seeking to understand how multiple physiological systems cause specific diseases – and how combination therapies may be needed to treat such complex illnesses.

 

1. Value in healthcare can be a tricky concept, but it generally encompasses the clinical and economic outcomes produced by the intervention compared to the total costs, risks, and potential adverse effects of the treatment option.
2. Haviland A., et. al., “Growth Of Consumer-Directed Health Plans To One-Half Of All Employer-Sponsored Insurance Could Save $57 Billion Annually,” Health Affairs, May 2012 31:5,1009-1015

Healthcare Turkey Talk

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.