"P in a Pod":(Physician Owned Distributorship): Physicians as Investors and Distributors in the Gadget Placed in Your Spine

If you have chronic back pain and your doctor refers you to an orthopedic surgeon who tells you that he or she can relieve the pain by inserting an appliance in your spine, there is a worry that the surgeon may be offering the surgery mainly for the surgeon's financial interest in that very appliance. 

What is "Physician Owned Distributorship" (POD) and what is its significance to medical practice and the ethical and lawful behavior of the profession?  To get some insight into the POD and its current status, what follows is an explanation as copied from an investigation published by Radio Station KPCC as part of the station's full presentation of the issue.

What is a POD?

A POD is a Physician Owned Distributorship. Under this business model, a doctor is an investor in, and distributor of, the devices or hardware he may put into his patients. Multiple doctors can have a financial interest in one POD.

Is that business arrangement legal?

In and of itself the arrangement is legal, but the Department of Health and Human Services’ Office of Inspector General has concluded that PODs are “inherently suspect under the anti-kickback statute.” It issued fraud alerts about PODs in 2006 and in 2013.

Can I find out if my surgeon is involved in a POD?

Currently, your physician is under no legal obligation to disclose that information. The Sunshine Act, a provision of the Affordable Care Act, does require that each year, certain medical device makers and distributors disclose to the Centers for Medicare and Medicaid Services ownership or investment interests held by physicians or their immediate family members. The law requires the Centers to post online the first batch of information it received by September.

Does the ‘Sunshine Act’ require my doctor to inform me that he is involved in a POD?

No. You will have to ask on your own, or search that Centers for Medicare and Medicaid Services website when it is published. The Centers say the site “will be organized and designed to increase access to and knowledge about these relationships and to provide information to enable consumers to make informed decisions.”

Yes, there are laws preventing physicians from referring their patients to facilities in which they own and invest for laboratory services or procedures. The Federal regulations called Stark (after Pete Stark, congressman who was its primary sponsor) can be summarized as follows: A physician may not make a referral to an entity for the provision of a designated health service (“DHS”) for which Medicare payment may be made (and the entity may not present a claim for services provided as a result of such a referral) if the physician or an immediate family member has a financial relationship with the entity unless either the referral or the financial relationship is “excepted” from the statute’s coverage.  To read more about Stark regulations, here is the link to a paper by Homchick and Looney which explains its current status.

Please read the excellent KPCC article about this unsettled and unsettling issue and then return back here and write what you would you think about Physician Owned Distributorship and its implications regarding providing the least expensive but the best in medical care.  Balancing the right of private investment by any person versus the need for unbiased decision-making and care by your physician, how do you size up POD, ethically, legally and if you were the patient with that back pain and were told "I have just the operation that can fix it"? ..Maurice.

Graphic: From Google Images and modified by me with ArtRage and Picasa3.

Can a Tree Experience Hurt?: If It Can, Do Ethics and Law Apply?

I was visiting a well known botanic garden in Southern California today, taking pictures of all the beautiful flowers when I saw this tree shown above in the pictures I took.  Honestly, what I saw, a tree apparently being pulled by straps out of its normal posture, pained me as I projected myself as if I were that tree.  Of course, I am not that tree but then this got me thinking about the bioethics of what had been done to the tree.  (First of all, I want to admit that I have no idea how long the straps were in place or for what future duration and what the gardeners were intending to accomplish with the straps since I haven't talked to the garden management. Finally, I am not sure that trees experience "hurt".)

Bioethics is not just about the ethics of humans and animals, healthy or with disease but it is also about ethics dealing with the plant kingdom. A current example of ethical concern is genetically modifying plants, including those we eat. And the question that came to me was whether what was done to the tree was unethical, that is, failing to meet the ethical standard for the principles of beneficence (to do good) and non-malificence (avoiding causing harm). But, though what I saw "hurt" me, the questions were whether the tree, a living creature of the plant kingdom was, in its own way, appreciating some "hurt" and with some ethical significance. Was the tree recognizing discomfort? Was the purpose of the straps to benefit the tree (which might be considered ethical) or to re-position the tree for its appearance to the benefit of the viewing public?  The latter might be considered unethical if the tree experienced "hurt".

To try to answer my concerns, as I often do, I go to Wikipedia to get a bit of help.  I found the article on Plant Rights which I have, as is permitted, reproduced below.  I would be most interested in the viewpoints of my visitors and perhaps they have found additional information regarding the science answering the question as to whether trees can "feel" or "express distress" to physical discomfort.  If they can, should they have themselves certain "rights" both legally and ethically? The question is either fascinating or just "dumb".  Tell me what you think...Maurice.

Plant rights

From Wikipedia, the free encyclopedia

Not to be confused with Plant breeders' rights.

Plant rights are rights to which plants may be entitled. Such issues are often raised in connection with discussions abouthuman rights, animal rights, biocentrism, or sentiocentrism.

Philosophy

On the question of whether animal rights can be extended to plants, philosopher Tom Regan argues that animals acquire rights due to being aware, what he calls "subjects-of-a-life". He argues that this does not apply to plants, and that even if plants did have rights, abstaining from eating meat would still be moral due to the use of plants to rear animals.^[1]According to philosopher Michael Marder, the idea that plants should have rights derives from "plant subjectivity", which is distinct from human personhood.^{[2][3][4][5][6]} Philosopher Paul Taylor holds that all life has inherent worth and argues for respect for plants, but does not assign them rights.^[7] Christopher D. Stone, the son of investigative journalist I. F. Stone, proposed in a 1972 paper titled "Should Trees Have Standing?" that if corporations are assigned rights, so should natural objects such as trees.^[8][9]

Whilst not appealing directly to "rights", Matthew Hall has argued that plants should be included within the realm of human moral consideration. His "Plants as Persons: A Philosophical Botany" discusses the moral background of plants in western philosophy and contrasts this with other traditions, including indigenous cultures, which recognise plants as persons—active, intelligent beings that are appropriate recipients of respect and care.^[10] Hall backs up his call for the ethical consideration of plants with arguments based on plant neurobiology, which says that plants are autonomous, perceptive organisms capable of complex, adaptive behaviours, including the recognition of self/non-self.

Scientific arguments

In the study of plant physiology, plants are understood to have mechanisms by which they recognize environmental changes. This definition of plant perception differs from the notion that plants are capable of feeling emotions, an idea also called plant perception. The latter concept, along with plant intelligence, can be traced to 1848, when Gustav Theodor Fechner, a German experimental psychologist, suggested that plants are capable of emotions, and that one could promote healthy growth with talk, attention, and affection.^[11] The Swiss Federal Ethics Committee on Non-Human Biotechnology analyzed scientific data on plants, and concluded in 2009 that plants are entitled to a certain amount of "dignity", but "dignity of plants is not an absolute value."^[12]

Legal arguments

When challenged by People for the Ethical Treatment of Animals to become vegetarian, Timothy McVeigh argued that "plants are alive too, they react to stimuli (including pain); have circulation systems, etc".^[13][14] The Animal Liberation Front argues that there is no evidence that plants can experience pain, and that to the extent they respond to stimuli, it is like a device such as a thermostat responding to sensors.^[15]

In his dissent to the 1972 Sierra Club v. Morton decision by the United States Supreme Court, Justice William O. Douglas wrote about whether plants might have legal standing:

“

Inanimate objects are sometimes parties in litigation. A ship has a legal personality, a fiction found useful for maritime purposes... So it should be as respects valleys, alpine meadows, rivers, lakes, estuaries, beaches, ridges, groves of trees, swampland, or even air that feels the destructive pressures of modern technology and modern life...The voice of the inanimate object, therefore, should not be stilled.

”

Samuel Butler's Erewhon contains a chapter, "The Views of an Erewhonian Philosopher Concerning the Rights of Vegetables".^[16]

The Swiss Constitution contains a provision requiring "account to be taken of the dignity of creation when handling animals, plants and other organisms", and the Swiss government has conducted ethical studies pertaining to how the dignity of plants is to be protected.^[17]The single-issue Party for Plants entered candidates in the 2010 parliamentary election in the Netherlands.^[18] Such concerns have been criticized as evidence that modern culture is "causing us to lose the ability to think critically and distinguish serious from frivolous ethical concerns".^[19]

In 2012 a river in New Zealand was legally declared a person with standing (via guardians) to bring legal actions to protect its interests.^[20]

References

References[edit]

1.      Regan, Tom (2003). Animal rights, human wrongs: an introduction to moral philosophy. Rowman & Littlefield. p. 101. ISBN 0-7425-3354-9.

2.      http://www.mdpi.com/2075-4698/3/1/16/pdf

3.     Marder, Michael (2013). Plant-Thinking: A Philosophy of Vegetal Life. Columbia University Press. ISBN 978-0-231-16125-1. http://www.amazon.com/Plant-Thinking-A-Philosophy-Vegetal-Life/dp/0231161255/ref=sr_1_1?ie=UTF8&qid=1358962348&sr=8-1&keywords=plant+thinking

4.      Marder, Michael (April 28, 2012). "If Peas Can Talk, Should We Eat Them?". The New York Times.

5.      Marder, Michael (May 8, 2012). "Is Plant Liberation on the Menu?". The New York Times.

6.      http://www.aljazeera.com/indepth/opinion/2013/01/2013120141156284755.html

7.      Vesilind, P. Aarne; Gunn, Alastair S. (1998). Engineering, ethics, and the environment. Cambridge University Press. p. 94. ISBN 0-521-58918-5.

8.      Stone, Christopher D. (2010). Should Trees Have Standing? Law, Morality, and the Environment (Third ed.). Oxford University Press. ISBN 0-19-973607-3.

9.      Stone, Christopher D. (1972). "Should Trees Have Standing--Toward Legal Rights for Natural Objects". Southern California Law Review 45: 450–87.

10.   Hall, Matthew (2011). Plants as Persons: A Philosophical Botany. SUNY Press.ISBN 1-4384-3428-6.

11.   Michael Heidelberger Nature from within: Gustav Theodor Fechner and his psychophysical worldview 2004, p. 54

Graphics: Photographs taken by me  June 12 2014

Patient Modesty: Volume 66

 The inattention to patient physical modesty in the medical system is just one part of a whole system-wide issue of inattention to the patient.  A good example of such inattention in another area is that of the behavior of the medical system to a physical injury is told by a physician who was injured and describes her experience in a hospital emergency room and later on the wards. While this physician's story is not strictly about medical staff ignoring her modesty, I think it does show major causes for inattention in many areas of medical practice: putting more emphasis to attend to making a diagnosis or just be seen as "doing something" for the patient but, because of workload, available time,need to rush ahead, follow protocol and move on, that attention to the patient as a unique individual with their individual needs and requests is simply ignored.  I think that unless the medical system expands its population of available healthcare providers and these providers are trained to think about the patient as an individual person as themselves, the sad experiences described over the years on this blog thread and the "hurt" (not simply the trauma) that this doctor felt as a patient will just continue onward. ..Maurice.

ADDENDUM:  I changed the graphic today for this Volume in order to emphasize what should be the
theme for the Patient Modesty thread: PATIENT  CENTERED CARE.

NOTICE: AS OF TODAY  JULY 14 2014 "PATIENT MODESTY: VOLUME 66 WILL BE CLOSED FOR FURTHER COMMENTS. YOU CAN CONTINUE POSTING COMMENTS ON VOLUME67.

Graphic: From Policy and Medicine

"This is Mine!": Property and Ethical Rights of Your Body by Yourself and Others

Jean-Jacques Rousseau, Discourse on Inequality, 1754  wrote "The first man who, having fenced in a piece of land, said 'This is mine,' and found people naïve enough to believe him, that man was the true founder of civil society."  Of course, property rights has continued through the ages and their defense has let to law suits as well as wars.  The question in recent years as applied to the human body is how property rights are applied to the body or tissues or cells or the genetic DNA of the cells themselves.  I found a very interesting discussion of this issue titled "Whose Body Is It Anyway?  Human Cells and the Strange Effects of Property & Intellectual Property Law" written by Robin Feldman, Professor of Law and Director, Law & Bioscience Project, UC Hastings College of the Law and which can be accessed through this link.

She begins her analysis with the following:

 "There are many aspects of our lives over which we can exercise what can be  called ownership, control, or dominion. However one conceptualizes ownership, it is  clear that people can hold such rights in many things, ranging from more concrete items,  such as automobiles, jewelry, or a plot of land, to more abstract concepts such as our  labor, our writings, our innovations, and even our commercial image.

Whatever else I might own in this world, however, it would seem intuitively obvious that I own the cells of my body. Where else could the notion ofownership begin, other than with the components of the tangible corpus that all would recognize as 'me'?

The law, however, does not view the issue so neatly and clearly. Through the rambling pathways of property and intellectual property law, we are fast approaching the point at which just about anyone can have property rights in your cells, except you. In addition, with some alteration, anyone can have intellectual property rights in innovations related to the information contained therein, but you do not.

I should be clear at the outset that I am talking about property and intellectual

property rights to cells when they are no longer in your body. The sanctity of control over one’s body remains reasonably intact, as long as the cells are attached to you. When cells are no longer attached, however, the legal landscape shifts, and the resulting tableau has a strong effect on the choices one can make with those cells that do remain in the body.

As so often happens in law, we have reached this point, not by design, but by the piecemeal development of disparate notions. Various doctrinal strands have emerged in isolation of each other, each appearing to solve a particular problem in its own domain. When gathered together, however, the doctrines form a strange and disconcerting picture."

As one can see from her discussion, the answer to my question has been legally muddled over the years.  My question to my visitors here is how do you look at the property rights of your own bodies? Should you have potential control of any cells or tissues removed from your body both when you are alive and even after death?  If the cells or tissues are used by others which end up in financial gain, should you or your  beneficiary also have access to that gain? How far should your exclaiming  "This is Mine" apply? ..Maurice.

Graphic: Photograph taken by me June 7 2014 and modified using Picasa3.

The Ethics of Delay: A Good or a Bad?

The following article I wrote for Bioethics.net is reproduced here with permission.

06/02/2014

THE ETHICS OF DELAY: A GOOD OR A BAD?

by Maurice Bernstein, M.D.

Delay, something late or postponed, can be looked upon as either ethically good or ethically bad. The difference depends on the basis for the delay, whether it was intentional and, if so, what purpose and what was the outcome. Unintentional delays, may be either a good or a bad depending on its origin and the outcome. Intentional delays may be the result of following the Precautionary Principle. The Principle emphasizes the need to be aware of the consequences of an action or inaction.  If the action is necessary to prevent known harm then the action should be carried out.  On the other hand, if there is no definitive evidence that the action will prevent harm but is likely to produce it or increase its risk, then following the Precautionary Principle, one should avoid or delay the act.

Delay and its ethical consequences is a common experience in medical practice.  It may be the patient who delays a visit to a doctor for a symptom recognized by the patient as possibly representing some serious disorder but the visit is delayed by the patient’s fears of what the doctor may find and so the visit may be postponed to await a spontaneous resolution of the symptom. Following the Precautionary Principle, the patient, considering the symptom as serious should not delay but seek medical diagnosis.  On the other hand, when the patient’s symptom is evaluated by the physician and based on the physician’s experience and the literature, there is reason to consider the symptom trivial and that a CAT scan is unnecessary at this point, delaying the expense, radiation and the ever-present possibility of making an erroneous diagnosis, the physician may settle on delaying further workup and proceeding instead with further observation of the symptom and with attention to the patient’s comfort as necessary. By this approach the delay may be appropriate and ethical.

Interestingly, there have been proposals by professional organizations dealing with guidelines for medical practice that based on studies and following the Precautionary Principle, recommendations including delays or abandoning certain procedures like PSA testing for prostatic cancer, mammography, colonoscopy and screening chest x-rays for lung cancer.

Unintentional delays in diagnosis and treatment may be related to the physician’s inability to readily access appropriately needed diagnostic and consultative resources.  Nevertheless, when delay is not based simply on the Precautionary Principle, it is the professional responsibility of the physician to make an effort to resolve the delay and provide the patient the needed professional services.

In medical care, delay is unethical if it is based not on precautionary concerns or is unintentional but based on self-interest of physician or, indeed, the medical system itself. It is unethical because the goal of medical practice is to provide beneficence, primarily attempting to “do good” for the patient and whatever are the personal benefit for the physician or system is secondary.  If the delay shows no concerns by the medical profession  for the patient and the patient’s symptoms or illness then the delay is a “bad” and is unethical.

Although, all the facts are as yet unknown and yet to be further discovered, there is current public concern in the apparently profound delays in the scheduling, evaluating, diagnosing and treating of war veterans by the United States Veterans Administration hospitals and clinics.  If not accidental but designed specifically to meet the self-interests of the Veterans Administration’s staff and officers, such delays, in terms of the principles of beneficence, non-maleficence and justice would make such behavior considered unethical.

As noted above, delay, itself, in the performance of a professional duty, may be ethically either “a good” or “a bad” and the ethics evaluation must take into consideration all the facts including the rationale presented explaining the delay. However, particularly in medical practice, dealing with humans who may need prompt medical attention to preserve life and provide comfort, delay should never be hidden but always explained and promptly attended to resolve.