Monday, April 17, 2017

More Pharmaceutical Industry Price Gouging`

A recent New York Times article tells us that Lannett, a large generic drug maker, is echoing other companies I have written about in raising prices on its products by several hundred percent. Here's what Arthur Bedrosian, Lannett CEO, told a group of investors:
According to the investors, Mr. Bedrosian was asked if the price-hike business model in the drug industry was over. He chuckled and said no, adding that he had tripled the price of one of Lannett’s drugs that very morning. He did not identify which one, the investors said.
Mr. Bedrosian's "chuckle" may remind you of Donald Trump's cheerful boast about how he could grab women by the "pussy."

The market loves Lannett, which provides yet another example of market failure. In the future the market may ultimately punish Lannett the way it punished Valeant (see here and here) and Turing Pharmaceuticals, but by the time that happens patients will have been hurt and public and private payers will have been bilked of billions.

The NYT cites studies showing that when there are fewer than five competitors, our national theology of the wisdom of markets doesn't hold. That suggests a regulatory strategy that allows price regulation in the absence of adequate competition. Let's hope that Congress is prepared to act on the basis of protecting patients and the public from the kind of legal larceny the Mr. Bedrosian is chuckling about!

Saturday, April 8, 2017

A Personal View of the Medical Home concept

Into my mid 70s I felt remarkably fit. I was still playing tennis and taking my favorite hikes during the summer in Vermont. That changed when a mysterious problem I've written about in a couple of posts (here & here) set in.

As a result of the problem that developed, I've had more medical appointments in the last six months than in the previous 25 years. As someone with an interest in health policy & systems, my experience has sharpened my sense of what's required to make a "medical home" work. (For those who aren't familiar with the medical home concept, I've copied material from the Patient-Centered Primary Care Collaborative at the end of my post.)

Here's my patient's eye view of my experience:
  1. In the fall of 2016 I was floundering as to what to do about the problem, Whatever was causing pain and discoloration of my left foot/ankle/lower leg was still a mystery. My primary care physician (PCP) suggested seeing a dermatologist, something I hadn't thought of myself.
  2. The dermatologist said what she saw was unusual. She did a biopsy which, alas, came back as "non-specific changes," That meant we were still unsure. She could simply have sent me back to my PCP, but to her credit, she suggested that we get a second opinion from someone at the hospital my care group is associated with.
  3. Initially the referral went to the referral coordinator and an appointment was set with a presumably thoroughly competent dermatologist, but one who did not have more experience than the one I had seen. I discussed this with my PCP. He called the chief of the department who recommended a senior colleague who he said "is especially good with complex cases."
  4. I saw the recommended dermatologist who had some hypotheses about obscure possibilities and did two further biopsies which showed (a) clotting in the tiny blood vessels and (b) no inflammation. 
  5. With a narrower set diagnostic possibilities, the second dermatologist wrote to my PCP, recommending that I see a hematologist and suggesting some further blood tests. My PCP agreed, and referred me to an excellent hematologist with whom I had shared patients before I retired from practice ten years ago.
  6. By this time my blood count showed something new - an abnormal level of platelets, which are crucial for clotting. The hematologist prescribed a medication that acts on the bone marrow with the aim reducing the platelets. We've used the group's secure email to follow the counts and adjust the medication. We've only met in-person once, but the email communication has been very reliable.
  7. As the platelets have come down, the lower leg and ankle problems have completely cleared up. But the toes have not, and in particular my left fourth toe was exquisitely painful. Last weekend I saw an ugly open sore on the toe. I didn't know what gangrene looked like, but my imagination ran away with unpleasant possibilities.
  8. On Monday morning I was able to see an urgent care physician who allayed by fears and prescribed  oral and topical antibiotics. 
  9. I informed the hematologist and my PCP about the situation to make sure we were all "on the same page."
  10. Happily, the wound is improving, and the pain is markedly reduced. 
So what's the point of all these details?

For me it's this: in the same way that it takes a village to raise a child, it can take an "extended family" to treat a chronic condition. My experience has been one of receiving excellent continuity of care even though I've been bouncing between clinicians the way a pin ball bounces. But the clinicians were part of the same "family." They had access to the same electronic health record and communicated with each other - either directly or via my sending "FYI" updates to them. For the underlying chronic problem I've had my blood drawn at the practice's laboratory. The results get to the hematologist and to me within a few hours, and she has followed up with email advice very promptly.

My guess is that my treatment in the past few weeks has not occupied much physician time, but as a patient I have felt very attended to. When I was worried about toe pain and an open wound I was able to see a clinician promptly, and her findings went to my PCP and the hematologist I am working with.

I believe my experience shows how a "medical home" and "team care" can be more than euphemisms. Continuity of care doesn't require continuous appointments with a single physician. When a "medical home" functions the way a harmonious extended family does, it works!

Here's the material about the medical home concept for those who want to read about it in more detail:

The medical home is best described as a model or philosophy of primary care that is patient-centered, comprehensive, team-based, coordinated, accessible, and focused on quality and safety. It has become a widely accepted model for how primary care should be organized and delivered throughout the health care system, and is a philosophy of health care delivery that encourages providers and care teams to meet patients where they are, from the most simple to the most complex conditions. It is a place where patients are treated with respect, dignity, and compassion, and enable strong and trusting relationships with providers and staff. Above all, the medical home is not a final destination instead, it is a model for achieving primary care excellence so that care is received in the right place, at the right time, and in the manner that best suits a patient's needs.
In 2007, the major primary care physician associations developed and endorsed the Joint Principles of the Patient-Centered Medical Home. The model has since evolved, and today the PCPCC actively promotes the medical home as defined by the Agency for Healthcare Research and Quality (AHRQ)

Features of the Medical Home

Adapted from the AHRQ definition, the PCPCC describes the medical home as an approach to the delivery of primary care that is:
  • Patient-centered: A partnership among practitioners, patients, and their families ensures that decisions respect patients’ wants, needs, and preferences, and that patients have the education and support they need to make decisions and participate in their own care.
  • Comprehensive: A team of care providers is wholly accountable for a patient’s physical and mental health care needs, including prevention and wellness, acute care, and chronic care.
  • Coordinated: Care is organized across all elements of the broader health care system, including specialty care, hospitals, home health care, community services and supports.
  • Accessible: Patients are able to access services with shorter waiting times, "after hours" care, 24/7 electronic or telephone access, and strong communication through health IT innovations.
  • Committed to quality and safety: Clinicians and staff enhance quality improvement to ensure that patients and families make informed decisions about their health

Tuesday, March 21, 2017

Adding Value by Talking More

A recent article in the New England Journal of Medicine - Adding Value by Talking More - caught my eye. For me, having practiced psychiatry for 43 years, the authors' argument was preaching to the choir. But what is special about the article is the hard-nosed way it cites data that demonstrates cost savings from investing time and money in well-planned conversation.

Here's the final paragraph of the article:

As these examples illustrate, increased physician communication is time very well spent when it leads to better patient outcomes and lower total costs. Clinicians who are reimbursed under new value-based payment plans should seize the initiative to determine how much of their valuable time should be spent in the various types of productive conversations, especially as they become more accountable for their results. Physicians now have the discretion, incentives, and accountability to use their time wisely and productively to reduce the total costs of patient care and improve the outcomes they deliver.
The otherwise excellent article omits one crucial element. Talking more with our patients also increases physician satisfaction. In conversations and CME sessions, when physicians are asked about meaningful clinical experiences, relationships with patients and moments of empathic connection predominate.

I encourage readers to go to the NEJM article. The three authors are all from the business school and the consulting world. They makes the kind of case for "talking more" that administrators will understand and be influenced by. I also encourage readers to go to the website of Avant -garde Health, a health care technology and analytics company founded by one of the authors.

Some harried physicians, unhappy in practices in which talking with their patients feels like a luxury they can't afford, choose to move into a concierge model of practice, in which they (a) limit the number of patients they care for and (b) charge an "entry fee" to be part of the practice. This solves the morale problem for the individual physician, but it weakens the health system itself by reducing the number of available primary care physicians.

The kind of work behind Adding Value by Talking More is addressed to the same problem concierge physicians are dealing with, but at the population level. As such it is a more socially responsible approach to the effort of making our health system more "patient centered."

Sunday, March 19, 2017

Access to health CARE vs access to health INSURANCE

A dear friend who follows this blog sent me an email about the two posts I wrote last week about my own recent medical experiences (here & here). With my friend's permission I've copied the message s/he sent [I'm deliberately disguising gender], edited to protect confidentiality and to highlight the themes I want to emphasize:
Thank you for the very informative posts. In general, however, I think the blog doesn't describe the experience of patients who are not MDs and/or are not in an integrated group practice such as the one you belong to. In my own experience, PCPs defer to specialists and won't contradict them. Further, the placebo effect of the PCP relationship is reduced if not nullified by the patient's difficulty in contacting the PCP over the phone. I can never get an appointment on short notice with my PCP; I can only count on seeing him if the appointment is made months in advance, or if I am in an emergency ward or am admitted to a hospital as an inpatient. If I have an immediate problem that is not an emergency (e.g., burn, sprain/suspected fracture, bronchitis), I have to work through two layers on the phone (secretary, medical assistant) -- and then the outcome will be an examination by a nurse practitioner. I therefore now prefer to use the XYZ Hospital's Walk-In Clinic rather than even trying to reach my PCP's office by phone. Finally, your encomium to the email system doesn't apply to the sharing of medical records between hospitals on different systems (e.g., XYZ hospital and ABC, where I have also had care) or to practice groups that are located in one and the same hospital office building but that don't share the same medical records system.
My friend is well insured - s/he has no problem with insurance access. And the community where s/he  lives is replete with medical services.

In a follow up conversation I will ask my friend about experience with the nurse practitioner. Over the decades of my clinical practice, and in my own care, I've had terrific experiences with nurse practitioners and physician assistants. Assuming that the NP is indeed a skillful clinician, the PCP can foster trust and comfort with the NP by explaining how they collaborate and demonstrating how they work together.

My positive experiences have definitely been fostered by the fact that I'd been a clinician in the group practice from which I was getting my care. But I'm convinced that a patient who had not had a career in health care and had not been part of the group could have a comparably positive clinical experience if they had the same skills I have in managing my care experience.

I anticipate that in the future, patients will routinely have electronic access to their own medical records. That kind of access, combined with a robust secure communication system with and within the practice, would promote more secure connection to the medical home than my friend experienced.

From 1975 until I ended my clinical practice I was paid a salary. That meant I was not dependent on billing for each in-person service for my compensation. One of my patients who had significant depression and was dealing with major stressors strongly preferred the convenience of electronic interchange rather than coming to my office. After we had gotten to know each other in 5-6 in-person appointments, we switched to email, which we used for ten years. When we met to say goodbye in person when I retired from practice, we felt we knew each other very well, but neither remembered what the other looked like, which made for some amusing uncertainty in the waiting room. Being paid by salary meant that I was not "penalized" for providing care to my patient with so few in-person meetings.

It's not likely that we will have enough PCPs to ensure prompt access for all patients in the foreseeable future. To provide the kind of secure connection my friend was looking for we'll have to manage the process of team collaboration better than s/he has experienced, and make use of electronic forms of communication to augment connection between the patient and the team.

The generation moving into adulthood is schooled in making electronic connection with their peers. They will demand that kind of opportunity in their medical care.

Wednesday, March 15, 2017

Chronic pain, Identity, and Health System Ethics

Prior to this past year my experience of pain had been with acute episodes. An especially painful and amusing episode occurred when I started a new job at the Massachusetts Mental Health Center after residency and fellowship. Between painting rooms in the house we were moving into and carrying boxes hither and yon I threw out my back. I lay on the floor, hardly able to move. A helpful neighbor called his PCP who came to the house. (It was 1970 and house calls actually happened.) I could see that he was regarding me with suspicion. Perhaps I was a newly arrived addict who was seeking an opiate fix. And when I started my new job, in some of my meetings I again lay on the floor, giving a rather odd impression of the new hospital ward supervisor.

The pain was severe - perhaps 9 or even 10 on the ubiquitous 0-10 scale. But I knew it would clear up before too long, and it didn't burrow into my psyche and sense of self. In the (slightly altered) words of the old spiritual, it "pained the body but not the soul."

Not so with the chronic pain I wrote about 3 days ago! It's not as severe as the back spasm, but the (a) chronicity and (b) uncertainty about if and when the pain will go away has (c) taught me lessons I only understood from the "outside" during my years of practice and (d) challenged my sense of identity.

Like many physicians, my default mode is to help others. Over the years, when asked "how are you?" my typical answer has been a hearty, upbeat "excellent!" So for the simplest of tasks - taking out the garbage and even putting on my pants (I have to protect the toes from contact with the pants leg - not easy to do) - to become difficult or impossible is a shocking change. My wife has taken over my "chores" cheerfully and uncomplainingly, but I feel ashamed at (my words) "not doing my part."

Before the foot/ankle/lower leg problem set in, I took an extended walk whenever the weather permitted, and played tennis with friends weekly. Sacrificing these activities isn't just a matter of losing forms of "recreation." Being an active, out-of-doors person has been part of who I am. These losses take another bite out of my sense of identity!

In a similar vein, I enjoy being at both of the two offices I use. But parking and walking to the office is difficult, and I can actually do most of my work from home, so I have been largely invisible at my work sites. My "productivity" may not be reduced, but collegiality is down, and loneliness is up.

Coping mechanisms are crucially important and put to the test. As an example, the toe/foot/ankle/lower leg pain is worst at night. When I try to sleep it wakes me up every 60-90 minutes. My initial reaction to these awakenings was anger, but that accomplished nothing useful and made it harder to get back to sleep. By an act of will I substituted humor - laughing at myself sitting in the dark massaging my foot and hobbling around to reduce the pain. Rather than saying "why the bleep is this happening to me" I say various forms of "what a ludicrous situation this is!"

This is a blog about organizational ethics. Readers may reasonably ask "what on earth does a painful foot and difficulty taking out the garbage have to do with organizational ethics?"

A lot!

Nowadays, organizations toot the horn about their commitment to "evidence based practice." Since the Hippocratic era, the practice with the strongest evidence of effectiveness is empathic listening. Organizations can encourage this stance or - all-to-often - squelch it with bureaucratic demands and processes that treat patients as targets for efficient "throughput."

Time pressure is a fact of life everywhere in health care, but there are skills we clinicians can develop to use time well, rather than having time use us. When I joined the mental health practice at the Harvard Community Health Plan HMO in 1975, the insurance limited the number of appointments we could have with our patients. Some clinicians put this limit front and center when they met new patients, by stressing what they couldn't do. Wise clinicians, however, approached new patients differently - "Let's first figure out what you need, and then see how we can best meet those needs." The HMO encouraged me and my colleagues to struggle with the challenge of remaining true to our mission while doing what was needed to make the necessary margin to keep the program going. (See here and here for examples of that work.)

Medical care ultimately comes down to the patient-clinician dyad, but more and more often the dyads occur in an organizational setting. Empathic listening is carried out by individuals, but organizations can encourage or thwart this deeply human process. That's where organizational ethics comes in!      

(A friend who knew about my left foot problem brought to my attention a superb article by the distinguished primary care physician Thomas Bodenheimer - "Lessons From My Left Foot." It's available at

Sunday, March 12, 2017

Health System Ethics and my Left Foot

I haven't written a post for more than 6 weeks. My left foot/ankle/lower leg are a big part of the reason for the lapse. So I decided to write about my experience and connect it to the topic of this blog -  health system ethics.

Many physicians have written about their own experiences of illness. Here's my  story.

In the fall of 2015 my left big toe itched. I didn't pay much attention until it began to hurt and develop redness. My primary care physician (PCP) was on a medical leave for a serious medical problem, so I saw another physician in his practice group. By that time I had red blotches on my foot as well. The physician had two hypotheses:

   (1) It might be an early stage of "vasculitis" (inflammation of the blood vessels). She did some blood tests, all of which were normal, and referred me to a rheumatologist (a specialist in autoimmune and musculoskeletal conditions).
   (2) It might be a circulatory problem, and she referred me to a vascular surgeon.

The  rheumatologist did a thorough evaluation with many blood tests. Except for two minor abnormalities, all were normal. He concluded that I did not have a systemic illness.

The vascular surgeon also did a thorough evaluation and a CT scan to visualize blood flow to my legs and feet, which showed adequate circulation with no visible blockage.
Lesson # 1: The specialists were excellent, but when they didn't find a problem within their purview, I was left with a "what now?" question. Given the absence of my long term PCP I decided to be my own case manager. I believed more than ever in the importance of primary care as the key hub of the health care system.
The pain was better during the summer. Perhaps the warmer weather explained it. Whatever the explanation, I enjoyed the summer.

In the fall of 2016 the areas of red discoloration spread onto my left ankle and lower leg. Happily, my PCP returned to practice from his long term medical leave.
Lesson # 2: Apart from all of the valuable things PCPs do, at least for me, and I would guess for many others as well, there is a powerful placebo effect from having a solid relationship with a clinician one trusts for skill, knowledge, and a genuinely caring attitude.
On examining me and hearing my history, my PCP said - "This is really weird. I have no idea what's going on. I think we should involve a dermatologist." A couple of weeks later I saw a dermatologist who suggested a few possibilities and did a biopsy. The biopsy came back "non-specific" - i.e., it didn't tell us anything. She thought we should get a second opinion.

It took several weeks for this to be arranged. The very knowledgeable consultant I saw put forward some additional possibilities and recommended repeat biopsies. These showed (a) tiny clots in the small blood vessels and (b) no signs of an inflammatory/autoimmune process.

This told us what was happening, but not why it was happening.
Lesson # 3: Humility is a virtue. My PCP acknowledged having no idea of what was going on, but did have an idea of what to do next. The first dermatologist suggested getting a further consult within her own specialty. Their non-arrogance paid off!
On the basis of seeing blood vessel clots, the second dermatologist suggested that I  see a hematologist, who put together (a) the presence of clots and (b) the fact that in the previous month I had a mild elevation of my platelets (blood cells involved with clotting) that was (c) a bit higher on repeat measure. Before our appointment she had me do further blood tests. We'd been colleagues in the past and she sent me the following email:

"I had you do some special blood tests beforehand and, indeed, you have a JAK2 mutation which is present in people with Polycythemia Vera and Essential Thrombocythemia.  This likely explains your elevated platelet count. I will be suggesting starting Hydroxyurea pills – very easy and well tolerated, to bring down the platelets and hopefully prevent more problems in the future."
Lesson # 4: In the previous 14 months I'd seen 10 different physicians. Without good coordination, this would be a surefire recipe for chaos. When  my PCP returned he carried out the coordination function very well, but throughout the 14 months the secure email system my practice group uses was invaluable. I could write to one physician and copy the note to others. This aspect of the electronic infrastructure really paid off.
I've started the new medication (Hydroxyurea), but I'm very aware that we're still proceeding on the basis of hypotheses. Blaming the elevated platelets is a plausible explanation, but two elements don't fit. A year ago, after the problem was clearly underway, a blood test showed normal platelets. The hematologist speculated that "perhaps your platelets are more 'sticky' and clot more easily." That could be true, but it's a speculation. And if the platelets are the villains of the situation, why are the symptoms limited to my left foot/ankle/lower leg?
Lesson # 5:  In 1865, the French physiologist Claude Bernard, who, among other discoveries formulated the concept of homeostasis, wrote “physicians make therapeutic experiments daily on their patients . . . . [M]edicine by its nature is an experimental science, but it must apply the experimental method systematically.” When faced with illness and suffering, patients and physicians want certainty. But as Bernard recognized 150 years ago, certainty of the kind we can have in mathematics is not to be had in medicine. Patients, physicians, and the public, need to learn how to work with and live with the absence of bedrock certainty.
 In this post I haven't touched on the powerful psychological impact of chronic pain and disability. I'll do that in future posts. If you've read this far - thank you for your attention!

Thursday, January 26, 2017

Retirement from Clinical Practice

Next week I have the privilege of facilitating a meeting on retirement sponsored by the Massachusetts Psychiatric Society. On two counts I was happy to be invited to do this.

First, from the perspective of this blog, medical societies are significant organizational players in the world of health care ethics. A well-functioning medical society helps newly minted physicians find their way into practice, provides guidance throughout the active phases of clinical careers, and supports colleagues in concluding their practices in ways that work as well as possible for our patients and for our own well-being. If a medical society isn't strengthening the ethics of its members it's not doing its job!

Second, the invitation prodded me to review my own experience of retirement from clinical practice, with the aim of distilling some comments to launch a group discussion. These are my major thoughts so far:

DREAD: Even though I was only practicing 1/3 time, I was frightened at the prospect of clinical retirement. My fear showed up in two visual images. I identified with King Antaeus, the figure in Greek mythology who derived his strength from the earth. He challenged Hercules to a wrestling match. Each time Hercules threw Antaeus to the ground, Antaeus's strength was renewed. Hercules caught on, held Antaeus in the air and crushed him to death. In one version of the story he hurled Antaeus into space, where he became a constellation. In the other image I saw myself as a sailboat utterly becalmed and helpless. Both images conveyed a feeling that my vitality and worth as a human being came from my role as a practicing physician.

MENTORING: I asked to meet with a colleague who was 10-15 years older, who to my eye was negotiating his life in an admirable manner. I told him about my fear of ending clinical practice. He told me he'd had similar concerns, but was surprised to find an element of relief when he stopped practicing, even though he'd never thought of practice as a strain to be relieved. He gave me some other practical tips, but I still remember with gratitude his reassurance about my fears.
MONEY: The meetings my wife and I had with our financial advisor were crucial. Confidence that we wouldn't go down the tubes financially was necessary for proceeding with the retirement plan, but not sufficient in itself to assuage my fears.
ENERGY: When on Friday August 31, 2007, I acknowledged to myself that I was really going to end my practice at the turn of the year, a surprising thing happened. In a desultory way I'd imagined starting a blog about ethics at an undetermined time in the future. But when I pinned down the date by which I would end my practice, without any forethought I went to Google and put in "start a blog." The inner experience was as if a stream that had been flowing in one direction (clinical practice/identity as a clinician) shifted into a new direction (the blog and the beginning of a new identity). I started this blog that day.
DISORIENTATION: When I was working full time my days were organized - especially on days when I saw patients. For clinicians, our schedule of patients tells us why we should get up in the morning. Trying to help people who are suffering assuages doubts about our purpose in life. 
LONELINESS: Retiring from clinical practice didn't mean retiring from professional activities. I continued my cherished academic position and leadership of the Harvard Pilgrim Health Care ethics program. These activities provided important and valued human connections. But I missed the richness of clinical life - connections with my long term patients and colleagues.

I'm proud of the Massachusetts Psychiatric Society for its attention to the penultimate phase of clinical career and grateful for the opportunity to participate. The health professions are devoted to the well-being of patients and the public health. If clinical retirement is handled well, these values can be pursued in new ways after physicians hand up their clinical hats.