Friday, February 11, 2011

The Challenges of Modern Medicine

   The current practice of medicine has become a much more complex endeavor than at any point in history.  Not only has modern technology impacted the practice of medicine, but physicians now have to deal with issues such as government intrusion which has made things quite challenging.
    Physicians are being told what procedures they can and cannot perform by a group of people with no professional medical training, namely government bureaucrats working in the Medicare system.  The United States government’s Medicare program became effective in 1967; it was supposed to help senior citizens get medical care.  Although it now costs ten times more than initially predicted, many feel that it has helped elderly patients significantly. 
    However, how much harm does it do?  Government and academic researchers back away from even asking such a question. Recent events show how Medicare is destroying trust between patients and doctors in the name of cost cutting, fraud prevention, and other tangential items.
    What about the issue of cost cutting?  In 1999, Medicare unilaterally determined that two different blood vessel examinations to evaluate the risk for stroke would be ‘bundled” if the examination were done on the same day. When the two examinations were done on different days, the government would allow $32.10.  However, if the examinations were done on the same day the government would allow $16.05.  As a result, patients began getting nasty sounding letters from Medicare telling them that their neurologist, Lawrence R. Huntoon, M.D., Ph.D., of Jamestown, NY broke the law by charging more than $0.00 for his services. Only a government bureaucrat could believe that charging more than zero could be a sound way to run a business or could get away with such libel.  Dr. Huntoon, president of the American Association of Physicians and Surgeons (AAPS), fought back, but nevertheless felt he was losing the case because of the bureaucratic mudslide and engulfing him in a legalistic mess. Each set of bureaucrats, in turn, disobeyed the Medicare law. Some falsely told him that their decisions could not even be appealed.  However, Dr. Huntoon’s struggle fighting back against the bureaucrats finally succeeded. He showed over and over again that Medicare officials had been disingenuous or had outright lied to him, and just this past summer, the Medicare bureaucrats bid a hasty retreat.1 
   After one year of hearings and appeals, Dr. Huntoon was finally vindicated. The government finally agreed that the doctor’s examinations were indeed worth $16.05 rather than $0.00 and that the lower level bureaucrats were wrong.  Dr. Huntoon spent several hundreds of hours fighting this battle so that his patients would have the option of having these clinically necessary examinations.  If the zero value had remained, many patients could not be examined.
   The bureaucrats backed off only after attorneys threatened legal action and then only when ordered to do so by higher level Medicare bureaucrats. Although it is against the Medicare law for “any federal officer or employee to exercise any supervision or control over the practice of medicine”, the bureaucrats have a glossary of excuses to tell patients and doctors what they can and cannot do. The way the laws are written, bureaucrats make the final rules. When the government wants to ration medical care, it cuts the resources (both goods and services) going into the medical system.  When the government’s own policies bankrupt hospitals, insurance companies, and doctors, these government bureaucrats accept no personal responsibility.  Instead, they blames others. Dr. Huntoon says that he now spends half of his time seeking coverage and justice for his Medicare patients.  Medicare does the most severe damage by destroying patients’ trust in their own physician.
    While Dr. Huntoon’s appeal was winding its torturous way through the system, Medicare wrote many of his patients and told them that he was guilty of a crime because he charged more than $0.00.  These false accusations were made even before the doctor had been found guilty.  This libel destroyed many patients’ trust in their own doctor. 
    This loss of trust causes many patients to delay treatment while they seek another physician.  As a result, many patients undergo needless suffering. Medicare should stop micromanaging health care.  The right to make medical decisions should be returned to patients and their physicians.  Medicare patients should be given the option of choosing which kind of insurance to buy and how much to spend on it.  Real Medicare reform should not make patients and physicians subject to the whim of Medicare (government) bureaucrats.2
     It is difficult, if not impossible, to enter into any discussion of the doctor-patient relationship without broaching the subject of informed consent.  Informed consent assumes that a patient will receive all the information that he or she needs in order to make a decision regarding whether or not to undergo a particular set of tests or a particular operation.  This assumption is based upon the belief that there will be a dialogue between the physician and the patient and that a course of action will take place as a result of said dialogue.  Informed consent’s implicit demand for joint decision making confronts the painful realization that even in their most intimate relationships; human beings remain strangers to one another. One can only know and understand another to a limited extent.  However, the problem runs even deeper.  One can only understand oneself to a limited extent. The latter impediment powerfully reinforces the former, making it even more difficult to know another.3 It is very difficult, if not impossible, for a patient to maintain trust in a physician, especially if this trust is undermined by a government agency.
   Another issue facing physicians which was not an issue only a few years ago is the role of “third party providers” (insurance companies), particularly health maintenance organizations (HMOs). Traditionally—and romantically---the family doctor not only cared for the whole family but functioned almost as a member of the family.   He cared for the parents, delivered their babies, and saw grandparents through their last illnesses.  Delivering these services, he knew what it was to venture out beyond the office and hospital setting.  He made house calls, drank family coffee, and savored its gossip.4   Today, most patients not only do not experience their doctor, known to many as the ‘primary care physician’ (PCP) as a member of the family, but they are fortunate if they can see him or her for more than ten minutes during a routine visit.  Third party providers, in an effort to improve cost efficiency mandate that physicians see a huge volume of patients on a daily basis.  The following words of wisdom from third-party patients are offered as feedback to third party dependent physicians: 1) “Hi…how are you?...see you next time…” does not constitute a clinical history. 2) That stethoscope hanging around your neck looks quite professional; however, would it be too much trouble to put the earpieces in your ears when you listen to my heart and lungs? 3) What exactly does it mean when you say that would be the best treatment, but I cannot have it? 4) What is a 99213 and is it terminal? and 5) Doctor, would it be possible to slow your speech to the point where the sound comes out at the same time as your lips move? 
    If a physician can recognize one or more of these pearls in his or her practice, perhaps it is time to consider a more ethical, Hippocratic form of practice: third-party free practice.  Unless, of course, the physician really enjoys treating incidental patients and practicing bureaucracy instead of medicine.5   
    Francis Peabody concluded his famous lecture on “The Care of the Patient” with these words:
             [t]he good physician knows his patients through and through, and
  his knowledge is bought dearly.  Time, sympathy, and understanding
  must be lavishly dispensed, but the reward is to be found in that
               personal bond which forms the greatest satisfaction of the practice
               of medicine.  One of the essential qualities of the clinician is interest in
  humanity, for the secret of the care of patient is caring for the patient. 6

    While these words are as true today as they were in the 1920s, the modern physician is bogged down with so much bureaucratic paperwork that lavishly dispensing time on a patient would seem like more of a pipe-dream than a reality.     
    In December 2008, a civil action, Hall et al. v. Leavitt and Astrue, was brought before the United States District Court for the District of Columbia.  Gabrielle Kotoski gave a deposition in which she discussed her own work in the area of claims analysis for Medicare and the impact that Medicare’s regulations have on the very seniors that the program was designed to benefit.      
    Having served as a professional in the field of claims analysis, coding, and billing for Medicare for many years, it is her considered opinion that medical services/benefits under Medicare are inferior to medical services/benefits individuals are willing to pay for themselves. Individuals who have health insurance benefits superior to, or substantially better than, Medicare or have significant savings that they are willing to use for medical care should be free to make that choice.  Simply speaking, Medicare promises coverage for almost everything, but it does not deliver that coverage to its beneficiaries. It has to limit access to and ration care to control its massive, growing costs.
    The Federal Hospital Insurance (“HI”) Trust Fund was expected to pay out more in hospital benefits and other expenditures than it received in taxes and other dedicated revenues.  The Medicare Trustees have estimated that the HI Trust Fund will be insolvent by 2019, according to the 2008 annual report of the Social Security Administration.
    As a consequence, Medicare constantly struggles to avoid accelerating its expected insolvency.  Thus, like any other government-run program, Medicare functions through the use of force: controls, threats, limitations on physician and patient freedom, and often draconian penalties for innocent mistakes.  Through internal medical coverage policies, claim denials for lack of medical necessity and other mechanisms, Medicare limits its costs by limiting the medical care beneficiaries can get and the options they have.
    Physicians are the initial source of virtually all medical evaluations and are the decision makers regarding diagnostic and treatment options.  With ever increasing knowledge of the items and services for which Medicare will not pay, I have observed that physicians have become increasingly hesitant to offer some or all of them to their Medicare patients.  Hence, beneficiaries who otherwise might be interested in at least hearing about all options open to them for diagnostics and treatment might never learn about some of them.  Compared to the medical items and services that people who are willing to pay for themselves could be offered or would receive, those offered by Medicare are tragically inferior.
    When physicians are  aware that patients a) want to know all diagnostic and treatment options available to them, b) want to make their own choices about their medical care based upon the risk/benefit analysis and their ability to pay for a particular treatment (e.g. their insurance will pay for the care and/or the patients are willing to pay either alone or to supplement their insurance), the physician is free to practice medicine and work in exclusive partnership with his patient, offering all he determines to be best for the patient and unhampered by Medicare.  This is how medical care, ethically and morally, should be provided.
    In an effort to reduce out-of-control inpatient hospital costs, Medicare replaced its former cost-based payment with Diagnosis Related Groups (“DRGs”) in 1983. Under this scheme, Medicare pays a flat rate for virtually all items and services provided by the hospital during the patient’s admission based on the patient’s principle diagnosis upon discharge.  Each DRG is assigned an average Length of Stay (“LOS”) and relative weight which is used to determine the payment the hospital will receive.  With few exceptions, the hospital receives no additional payment if the patient stays longer than the LOS even if additional complications develop during the stay that were not recognized upon admission.  On the other hand, if the patient is discharged earlier, the hospital retains the difference.
    I have observed that DRGs are hazardous to Medicare patients.  Hospitals are incentivized to a) discharge the patient as early as possible and b) to cut costs by always providing the cheapest alternative for everything from supplies to nursing care.  It follows that hospitals are not incentivized to provide optimal care for as long as the patient needs it and until the patient is fully ready for discharge.  Not infrequently, patients who are seriously ill can be discharged to a lower level of care available only in the acute care hospital.
    For example, a recent case in the Midwest, the facts of which I am personally aware, involved a seriously ill diabetic Medicare patient one day removed from a long intensive care stay, still in kidney failure, unable to eat, still on antibiotics for a life threatening systemic/septic infection, where the case manager approached the spouse to discuss discharging the patient to home within two (2) days.  Physicians on the case did not intervene to prevent this appalling decision and were absent from the case for days, seeming oblivious to the situation, I believe, possibly because of hospital pressure to get rid of “the case”.  Had the spouse not expressed outrage and taken action to prevent the discharge the patient might have died.
    In another case, about which I am also personally aware, a Medicare patient, this time in the Southwest, with a serious digestive condition and lymphoma had been in the hospital two (2) weeks, some days in excess of the average length of stay (LOS).  No preparations for discharge had taken place (training in tube feeding, etc.) when the spouse was asked to look at four (4) nursing homes in the area as soon as possible because discharge was imminent.  Surprised, he carefully checked out each one, but came to the conclusion that none were acceptable or even safe.  With continued pressure from the hospital to move the patient to a nursing home, he informed them he intended to ask for a second opinion—from the state’s largest law firm.  The hospital backed down.
    Neither case is either unique or rare, but in both cases the patients are surviving today because a dedicated spouse was successful in persuading the hospital to incur additional costs for which it would not be paid.  The lives of Medicare patients living alone, without such a spouse or other loved one to intervene, are at far greater risk.
    In both the foregoing cases, the beneficiaries would have been financially able to pay for additional days in the hospital, having prudently saved and invested over the years.  However, they and all other Medicare beneficiaries are prohibited from doing so because the government prohibits private contracting with providers under 42 USC § 1395a(b). Hospitals are not allowed to charge the beneficiary directly for any covered service (save the deductible), but must submit all charges to Medicare for reimbursement, regardless of the length of stay or cost. Hence, Medicare policies and procedures are unquestionably a threat to the lives of Medicare patients.
   Contrast the above situation to individuals not on Medicare who have excellent insurance benefits and/or who are willing to pay for care themselves.  Freed from being subject to a system like Medicare, these people are free from the threat to their lives imposed by the high risk DRG payment system. 
   Medicare accomplishes its cost cutting efforts through multiple mechanisms.  Each contributes to making Medicare an inferior and, in some cases, an unsafe product for beneficiaries.  Those cost cutting/savings mechanisms are: a) The Medicare-physician fee schedule; b) Onerous regulations and physician documentation and billing requirements as well as threats of audit and prosecution for fraud and abuse of the Medicare program for mistakes; and c) Medicare coverage policies that have never been directly disclosed to Medicare beneficiaries and “medical necessity” claim denials.
    Access to care can be determined by whether (a) physicians, such as primary care physicians or certain specialists, are available in a patient’s community; b) physicians are accepting Medicare patients; c) certain diagnostic or therapeutic procedures are available or, more importantly, have been offered to the patient; or c) individualized treatment is available or provided to the patient.
   Through legislation and internal coverage policies written to limit costs and drastically reduce utilization of services, Medicare adversely and seriously affects every aspect of access to care.  Regarding item (a) for example, I am aware that many physicians have already retired or are in the process of retiring because of Medicare’s continuous and growing demands and intrusions into their delivery of care and their billing processes.  For many, the National Provider ID requirement was the last straw because it enables government to more closely monitor all future physician behavior and prescribing, forcing compliance with government dictates and enabling punitive action.  The loss of experience and knowledge these retired or retiring physicians possess is a loss not only for beneficiaries, but for entire communities because fewer physicians are left behind to serve the same size population.  In this regard, Medicare and government intrusion affects every American citizen.
  Also, physicians increasingly cannot afford to treat Medicare beneficiaries.  The fees that Medicare pay physicians are among the lowest in the nation with the exception of fees paid by State Medicaid (Medical Assistance) programs.  As an example, Medicare’s fee for a total knee arthroplasty for which the surgeon’s charge may be $6000 is approximately $1,193.  In addition, consider a breast needle biopsy performed by a radiologist using ultrasound guidance. The physician’s fee might be $1,500 but Medicare’s allowable would be only $107.38.  This procedure requires at least three quarters of an hour plus effort, including prior training and experience, which requires locating the mass in the image and then insertion of a needle to precisely capture the biopsy sample.
   Almost every year, Congress reduces physician fees in an attempt to reduce Medicare costs, only to eliminate part or all of the reduction after outrage, threats of leaving the program, and outright begging from physicians.
   “Participating” physicians contractually agree to accept Medicare’s “allowed amount”, the published fee, as payment in full for their services. “Non-participating” physicians, by law, cannot charge a Medicare patient more than 115% of 95% of the allowed amount (known as the “limiting charge”) for their services.  Under the law, neither category of physician is allowed to accept more from the patient than those charges.  Even if offered by a patient willing to do so, the physician must refuse to accept any payment above the amount established by Medicare.
   Low payments and threats of impending reductions from Medicare are a deterrent to a physician seeing Medicare patients.  Physicians, whose Medicare caseload may be as high as 30%, must see more patients each day to generate the income they need to operate their practice profitably and support themselves. Physicians who can reduce the number of Medicare patients and replace them with a smaller number of higher-paying, private-pay patients will do so because they can, therefore, render a higher level of care to their patients.  I have observed that more physicians are making this choice and are closing their practices to new Medicare patients.  There are many primary care physicians in my community of Albuquerque, NM, but only four (4) of them are accepting Medicare. Of those four, two (2) are not far from retirement and the other two (2) are newly in practice.  As further evidence, the American Academy of Family Physicians has published vivid testimonials from doctors in sixteen (16) states that amply demonstrate the scope of this problem. 
   Physicians are also opting out of Medicare altogether.  Agreeing not to bill Medicare for two (2) years under 42 USC § 1395 a(b), these opt-out physicians have spoken out and written elatedly about their release from Medicare claims and pressures.  Medicare beneficiaries can be treated by opt-out physicians, but neither the doctor nor the patient can bill Medicare for the service.  The beneficiary may pay out-of-pocket for the physician’s services.
   Now contrast the above to a patient who would be free to contract with the provider and be willing to pay for the services himself or whose insurance is superior to that offered by Medicare.  The physician may agree to accept the insurer’s payment as payment in full or, alternately, agree to accept a premium from the patient or all of the payment from the patient. In such an agreement, there is no coercion involved on either side. Each person trades with the other to mutual advantage.  Access to care for the patient is a non-issue.
   As discussed earlier, physicians are limiting their availability to Medicare beneficiaries by closing their practices to new Medicare patients due to the fact that they cannot afford Medicare’s low payments.  However, there are other reasons to close a practice to these patients.  Medicare can pose a serious threat to a physician.
   Always under the threat of audit, fraud, or abuse investigations from Medicare or law enforcement, physicians who consent to treat Medicare patients must conform to a myriad of rules when billing for their services.  For example, they must document their services to meet the definition of each billing code they submit on a claim (including special, detailed documentation requirements for every visit), obey all rules for using the billing codes, select the correct diagnosis code for each diagnosis being treated and be certain that the diagnosis code matches the billing code for logic and clinical relevance and meets Medicare’s internal coverage policies.  These are a daunting additional set of bureaucratic requirements to meet while focusing on a far more valid and moral goal, that of assessing and treating a patient.
   Innocent errors can result in monetary sanctions or even criminal prosecution. A serious Medicare and/or FBI audit of claims and documentation can literally destroy a physician’s practice, financial security, and his life.  It is no wonder that opt-out physicians or others who no longer see new Medicare patients are relieved.
   Few Medicare beneficiaries have any idea of the extent of these requirements and the additional pressures they exert on each physician who chooses to treat them.  Further, few know how such a threatening environment serves to limit access to physician care.
   For patients who would be free to contract with each physician, no such regulations and corresponding threats would apply.  Aside from an insurers need, upon request, to be able to see medical record evidence that the services were rendered, the physician and patient would be free to work together without the threat of those onerous requirements.  In these cases, access to care for the patient is simply a factor of physician availability and patient choice of services based upon her desires and financial ability to pay for them.
   To understand these Medicare methods to ration care, it is important to understand several key concepts.  First, Medicare’s formal “non-covered” services are virtually identical to those that are not covered by most health insurers.  They are specifically listed in the Medicare Act of 2003.  One example is cosmetic surgery.  Next, one must grasp the distinction between Medicare’s “formal” covered benefits, as stated in the Medicare Act, and its internal medical coverage policies.  The coverage policies are subsets of the formal “covered” benefits.
   The chief methods of “training” physicians to willingly select diagnostic or treatment alternatives Medicare will pay for and to withhold options they will not pay for are comprised of “medical necessity” claim denials and the medical coverage policies upon which these denials are based.  The sad result is that beneficiaries now have limited choices of diagnostics and treatments, and individualized therapy/management is no longer available or is strictly limited.
   “Medical necessity” is a Medicare term based upon a provision in the Medicare Act (Title XVIII of the Social Security Act [SSA]) which states that no Medicare payment shall be made for “items and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member.”  Unfortunately, “medical necessity” has not been defined by any government agency or official.  Therefore, there is no objective measure to determine what it means; each bureaucrat or contactor (private organizations that contract with Medicare to process Medicare claims) can, and often does, define it subjectively to suit his or her or their agency’s objectives. 
   In 1989, the Health Care Financing Administration (HCFA), predecessor agency to the current Center for Medicare and Medicaid Services (CMS), proposed a rule defining “medical necessity”; however, that rule was never finalized. In practice, the Medicare bureaucracy and it contractors often deny payment for medical services…even if the services are formally ‘covered’ by Medicare.  Based upon a Heritage Foundation study and HCFA statistics, nineteen (19) percent of all denied claims were denied because of ‘medical necessity’.  If one excludes those medical services which are denied because of ‘statutory exclusion’, that number rises to forty-five (45) percent.  Medicare contractors have denied payment for preoperative electrocardiograms (EKGs), treatment of precancerous skin lesions, and even the use of anesthesia in certain cases.
   A “coverage determination” is a written policy that either originates in CMS offices in Baltimore or as a national policy (NCDs) or at any contractor office at the local level as a local policy (LCDs).  These policies specify the condition or circumstances under which an item or service will or will not be reimbursed (covered).  They state the conditions under which an item or service will be deemed “medically necessary”, which is of crucial importance.
   On the national level, CMS periodically publishes National Coverage Decisions which must be observed by all contractors.  Relatively small in number, the policies commonly focus and interpret the formal covered benefits provided under the Medicare program.
   At the local level, Medicare contractors develop LCDs for those items and services that are not addressed by the NCDs.  The number of policies is large and growing larger.  Due to their number, these policies are chiefly responsible for claims being denied for lack of “medical necessity”.  Disturbingly, these policies can and do vary from region to region with one contactor allowing payment and another denying it.  For example, in a United States Department of Health and Human Services (DHHS) Office of Inspector General Report entitled, “Medicare payments For Surgical Debridement Services in 2004”, twelve (12) of the seventeen (17) carriers [contractors] “had at least one LCD that addressed surgical debridement services.  The remaining five (5) did not…” The report goes on to detail the variances in policy coverage among the twelve (12) carriers and noted that one (1) carrier had an LCD that “was significantly different from the other eleven (11) carriers’ LCDs.”
   One LCD currently in force for the use of biologic wound products (skin substitutes that are used to temporarily cover chronic or burn wounds) states that any use of the product not indicated by the Food and Drug Administration (FDA) literature is not considered reasonable and necessary and is therefore not covered by Medicare.  Hence, any use other than that stated in the FDA-approved literature, is not covered.  Such is blatant rationing of care.  For decades, physicians have legally made off-label use of substances, materials, and drugs that they determine, on an individual basis, would be effective for a specific patient.  Many patients have been and currently are beneficiaries of off-label use and prescribing.  Medicare, though, will not allow seniors to be among those beneficiaries.
   Another current LCD allows the use of the drug Leukine for its FDA indications only.  The indications are generally limited to treatment for neutropenia and support for bone marrow transplants.  However, numerous noted studies and currently accepted therapies have shown it to be effective alone or in combination with other drugs against advanced and otherwise untreatable prostate cancer. The drug is very expensive, over four thousand dollars ($4000) per treatment for prostate cancer and is not covered by Medicare regardless of the fact that the prostate cancer might be arrested in a durable remission or held in check by the therapy.
   Both foregoing therapies, among many others, would be denied as not “medically necessary” if provided for other than the indications listed in the policies.
   A Medicare denial for lack of “medical necessity” typically cannot be billed to the patient unless a) the provider accepts assignment (provider agrees, on the claim, to accept Medicare’s allowed amount for the item service as payment in full) on the claim and b) the patient has signed an Advanced Beneficiary Notice (ABN) agreeing to pay for the service if Medicare denies it as not “medically necessary” or the patient has refused to sign the ABN.  Providers who do not accept assignment cannot bill a patient who has refused to sign an ABN in these circumstances.
   However, providers often do not know when such a denial will occur, typically learning of it only after the fact.  Once the denial has occurred a few times, the provider may establish a policy to have the patient sign an ABN.  Alternatively, if other “medically necessary” treatment options are sanctioned by a coverage policy, the provider may not even mention the “medically unnecessary” treatment option to the patient.
   What if the denied treatment is one which the physician thinks might have been better for the patient?  In elective situations, the patient may or may not be informed of the better option.  The physician’s integrity, risk of tolerance and willingness to risk a financial loss determines whether or not the patient is informed.  In an emergency situation, the determinants are the same but can be complicated by the availability of the diagnostic or therapeutic option selected.
   On the other hand, what if a patient is told about the better treatment option and wants it?  An ABN, correctly executed, must be submitted for the item or service every time it is provided.  An exception applies for a series of treatments.  Each time the series is to be repeated, another ABN is required.  However, too many ABNs will likely cause Medicare to threaten the physician with sanctions for “systematically” performing care that is not “medically necessary”.
   Patients cannot contract separately with the provider in order to eliminate the ABN requirement that stands as a barrier to entry to obtaining the treatment both the physician and patient require since such private contracts violate 42 USC § 1395 a(b).
   Medicare’s coverage policies and “medical necessity” denials ration medical care for Medicare beneficiaries, making Medicare an inferior program, at best.  For an individual who would be free to contract with the provider and be willing to pay for the services herself or whose insurance is superior to Medicare, there would be no such restrictions.  The physician may agree to accept the insurer’s payment as payment in full or agree to accept part or all of the payment from the patient.  Access to care and rationing would not be a concern.
   Unquestionably, medical services/benefits under Medicare are inferior to medical services/benefits individuals are willing to pay for themselves.  Any individual who has health insurance benefits superior to or substantially better than Medicare or has significant savings that they can pay for her own medical care should be free to make that choice.  To force an individual to take Medicare benefits which she does not want or need is morally wrong.  However, to additionally penalize her tens of thousands of dollars by taking her Social Security if she does not take those benefits is outrageous.  It forces her into a second tier, government controlled health care program and she is then forced to accept the limitations imposed by the government.  She is no longer free to choose the care she alone desires and wishes to pay for.7
   The issue of patient confidentiality is another concern facing physicians today.    In the past few people other than physicians were in a position to harm a patient’s interest in his/her medical information. Parties not under a physician’s direct supervision were not likely to have access to medical or related financial records, for physicians were the de facto custodians of medical records, and payment did not involve a third party.  Today, medical care requires interaction and coordination among many individuals and services.8 Aspects of care are often delegated or first undertaken by licensed, or even unlicensed, care providers other than physicians.  Information is obtained, coded, and processed by employees of the physician or health care system, maintained in paper or electronic form, and transmitted to third party payers.9 The expanding number of those whose jobs provide them with access to medical information increases the risk that individuals will act outside the scope of authorization to obtain information they do not legitimately need to perform their work. Mark Siegler spoke of his amazement that in 1982 as few as 25 and as many 100 health professionals and administrative personnel had access to patients’ record and that each of them had a legitimate need and a professional responsibility to open and use those charts.10 After almost thirty years those numbers have gone up, not down.
    The electronic health information systems, in particular, that have proliferated in the past ten to twenty years may be particularly vulnerable to improper or abusive dissemination of health and related information, including risk of appropriation of critical unique identifiers and financial information. Vast quantities of medical and other personal information are now stored in cyberspace.  This information can be accessed by large numbers of health care workers, both physicians and non-physicians, and transferred in a matter of nanoseconds, posing the risk of inappropriate intrusion into highly sensitive personal information.11
    In summary, the very concept of confidentiality is extremely important with regard to the physician-patient relationship.  This relationship is built on trust between the patient and his/her physician. Anything which serves to potentially undermine this relationship, such as a breach of confidentiality on the part of the physician or others who have access to a patient’s personal health and financial
information will have an extremely adverse effect on the health care system.
    The Health Insurance Portability and Accountability Act of 1996 had a major impact on patient confidentiality. HIPAA assigns to covered entities–such as health care plans, clearinghouses, and health maintenance organizations—12 a duty to maintain “administrative, technical, and physical safeguards of health information” to preserve its “integrity and confidentiality”.13
   Effective in April 2003, the federal government gave  six hundred thousand  “covered entities“ regulatory permission to use or disclose health information for treatment, payment, and health care operations” (known as TPO) without patient
consent.14 Some of those “routine purposes” for which disclosures are permitted
are far from treatment.  In fact, “covered entities” and their “business associates” may share patients’ sensitive personal information for treatment, payment, and health care operations without the patients’ knowledge, over their opposition, and even if patients pay for treatment out of pocket or request the right to be asked for consent to disclosure of their medical records.15
   Particularly troubling is the governmental authorization for covered entities to use patients’ confidential health information without their consent for health care operations that are unrelated to payment or treatment. “Health care operations” (HCO) include administrative and profit-generating activities, such as auditing, data analyses of plan sponsors, training of non-health care professionals, general administrative activities, business planning and development, cost management, payment methods improvement, premium rating, underwriting, and asset sales—all unrelated to direct patient care.16 Health care operations also include some marketing (which otherwise requires signed authorization)
fundraising for covered entities.17 In addition, covered entities may share patient information with millions of contracted “business associates” without patients’ consent.  Like covered entities, their business associates are supposed to keep patient information confidential.18      
    However, because amended HIPAA rules permit broad uses under health care operations and do not require an audit trail for “routine” disclosures, there is no
way to monitor whether health information is shared in ways inconsistent with contractual requirements or patients’ wishes.  Thus, if patients have problems with employment or insurance because of unauthorized disclosure of their health information, the patient cannot trace the harm to a disclosure authorized under health care operations.19
     Confidentiality is at the heart of the physician-patient relationship and consent is an essential means by which patients can assure that information remains confidential.20 There is a great need for such assurance because any problem that could arise with health care disclosures probably will as Ted Cooper of
Kaiser Permanente noted in 2000 when he recommended that HIPAA be “crafted
from the perspective of how we would want” our family’s health data handled, “every permutation that can happen will happen.”21 According to health attorney
James Pyle, “information such as a name and diagnostic code …could be enough to derail your prospects for a loan or a job. You could be charged higher loans rates or lose a job because of what’s in your medical record…and it will be impossible to prove it was because your data was shared…because there is no disclosure of audit” trail under HIPAA.22 For years medical privacy was protected—by ethical codes, state and federal statutes and administrative regulations, tort law (which, unlike HIPAA, gives patients remedies), accrediting organizations, hospital policies, even the market—long before HIPAA gleamed in
a bureaucrat’s eye.  As Richard Epstein notes, before HIPAA we saw no “explosion of improper disclosures of sensitive information, and no systematic
unwillingness to deal with the problems that do arise by private organizations or even by more limited and focused regulatory responses.”23 Due to the lack of limitations, potentially harmful information is likely to be shared within the course
of basic health care operations, and HIPAA actually facilitates that sharing,
without patient authorization, even if other laws might prohibit the use of the information.24
     Informed consent has also become an issue in the practice of medicine.  Valid informed consent is standardly understood to have three components. First, the patient must have been informed about her diagnosis, available alternative treatments for her condition including her rational and likely prognoses with those treatments as well as with no treatment.  Doctors are responsible for providing this information to patients in an understandable form.  Second, patients’ choices must be voluntary.  This means that the choice must have been made without coercion, manipulation, or undue influence by others such as physicians or other family members.  Doctors are responsible for ensuring that patient choices are voluntary, which means helping to free patients from coercive forces when necessary.  The third requirement for valid consent is that patients have decisional capacity or competence to give or withhold valid consent to the treatment in question.25 Should there be any doubt regarding a patient’s competence to make such health care decisions this issue may have to be decided in court.
      Patients have a legally protected right to refuse treatment.  The right to refuse treatment has been grounded, most importantly, in federal and state constitutions.  In a series of cases over the last two decades, namely, Washington v. Harper (1990), Riggins v. Nevada (1992), and Sell v. United States (2003), the Supreme Court has recognized that a competent person has a constitutionally protected “liberty interest” in refusing unwanted medical treatment.  The Court’s jurisprudence provides ample reason to believe the Constitution safeguards treatment decisions, which are among “the most intimate and personal choices a person may make in a lifetime, choices central to personal dignity and autonomy.”26
   The third criterion for informed consent is that patients have decisional capacity or competence to give or withhold valid consent to the treatment in question. In the area of medical ethics, no diagnosis has caused more battles than the persistent vegetative state (PVS).27
   The term made its debut in 1972 and is defined as “…a clinical condition of complete unawareness of the self and the environment accompanied by sleep-awake cycles with either complete or partial preservation of hypothalamic and brainstem autonomic functions.”28
   The cognitive abilities of some patients who have been misdiagnosed as having PVS are astounding.  A review article on PVS discussed the findings of one study, done in a rehabilitative unit, as follows: “The level of cognitive functioning present in this misdiagnosed group at the time of discharge was considerable: 60 percent were oriented in time, place, and person; 75 percent were able to recall a name after a fifteen minute delay; 69 percent were able to carry out simple mental arithmetic; 75 percent were able to generate words to communicate their needs; and 86 percent were able to make choices about their daily life activities.29
    Awareness, unfortunately, is very difficult to assess. It is highly subjective and highly dependent on the skills of the examining neurologist, the time spent examining the patient at the bedside, the physical capabilities of the patient to provide a response, and a multitude of other factors.
    The technology needed to assess “internal awareness” (awareness without behavioral response) is still in its infancy.  A study published in February 2005 revealed activation of cortical networks in minimally conscience state (MCS) patients, who are understood as having “a condition of severely altered consciousness in which minimal but definite behavioral evidence of self or environmental awareness is demonstrated”30, using functional MRI mapping.  The study reported “These findings of active cortical networks that serve language functions suggest that some MCS patients may retain widely distributed cortical systems with potential for cognitive or sensory function despite their inability to follow simple instructions or communicate reliably.” Other studies have reported that certain cognitive evoked potentials are useful in predicting awakening from coma.31  
    Courts, of course, are poorly equipped to understand the complex issues that often center on medical semantics and consensus definitions used to describe a continuum of awareness in neurologically devastated patients. However, in many cases it is left up the courts to determine the course of medical action based upon the fact that many patients do not have an Advanced Directive which provides written instructions, given by the patient, should the patient not be able to speak for herself.
    With respect to the patient’s presumed wishes, hearsay is often the deciding factor. Those who talk casually over a few beers would be well advised to watch what they say, as their words may lead to unimagined consequences if they are ever diagnosed as being in a PVS. 
   No one can say exactly how much awareness a patient must display in order to qualify for continued food and water.  Is a smile in response to a mother’s kind words sufficient?  Is visually tracking a balloon over a sustained period enough? What about grimacing and turning one’s head away from an unwanted swab around the mouth?  What happens if the patient is tired from physical therapy or a bath when the doctor comes by to evaluate?
   Perhaps it is just too much energy for some to play the game and respond when asked to perform. There ought to be some way to warn such patients: You have the right to remain silent and not respond, but if you choose not to respond or are unable to respond your food and water may be taken away by a court of law.  
   Scientific medicine deals with disease; its worldview of the sick is the view of disease.  The matter in which physicians are trained quite naturally emphasizes and reinforces the current definitions of disease and the view of illness that such definitions promote and their education stresses the rational analytic thought of science. 32
   The historical roots of the problem regarding the dichotomy between the analytic (objective) and humanist (subjective) views of medicine can be traced back to Rene Descartes (1596-1650) and the mind-body duality.  This was effectively a moral-technical duality: physicians, in company with other scientists, were given the (technical) body, while the philosophers and theologians were assigned the (moral) mind.  Obviously the controversy has not cooled.  At issue is the degree to which the mind-self-soul is part of the human machine, and therefore understandable in the terms that define that machine.  That part not understandable in scientific (machine) terms is involved with values and morals.33
   The issue of transplantation medicine raises concerns with regard to the teachings of Descartes. In his 1632 treatise De Homine, Descartes described man as an articulated puppet governed by his mind. Muscle movements, the senses of touch, tasting, hearing, smelling, seeing; hunger and thirst; the different moods of the psyche, and waking and sleeping are all defined by him as mechanical processes. The mind, which is located in the brain, ranks hierarchically above the soulless body. For this dualism to be formulated, the anatomical representation of the human body as a corpse is a necessary precondition.34
    The anatomical-mechanistic view of humanity stigmatized and defined by death, reaches a new climax with its concept of brain death, upon which transplantation has depended since the 1960s. It applies the logic of the Cartesian body machine to the process of dying.  The brain is considered to be the all-important “locus” of the person and therefore also of his death, implying a disjunction between the brain (and its death) and the death of what is regarded as the “surviving bodily remains”.35 In this disjunction, those remains are viewed as alive.  In some cases transplantation doctors classify a brain dead patient ontologically as a “human vegetable” as a “remaining body” or as a “heat lung package”.36 Death as an event is therefore equated with a single aspect and limited to a single organ, which negates not only death as a process in the biological sense, but also the dying of a person as a social event.  Whereas, according to the philosopher Hans Jonas (1903-1993), before the days of modern brain death legislation the removal of organs was considered an act of vivisection, surgery conducted for experimental purposes on a living organism, now the time of death and the point of time at which it is permissible to remove organs from the body of a brain dead patient has been pushed back solely on the basis of a definition.37
   How flexible this definition of brain death is can be shown by the following: When Christiaan Barnard (1922-2002) carried out his first spectacular heart transplantation in South Africa in 1967, a Harvard University commission established the criteria of brain death, which included absence of all kinds of reflexes, including those originating in the spinal cord, 38 a morphological extension of the brain. However, within the same year of 1968 the criterion was narrowed to refer to absence of cranial nerve reflexes. Brain dead patients may have a number of elicitable reflexes that require only a functioning spinal cord.39  
   Instead of coming up with the strongest possible definition of brain death possible, the Harvard commission actually weakened the definition which led numerous physicians’ groups to reject the new concept of death and raise ethical condemnations. 
    These ethical condemnations were followed by criticisms of the brain death definition especially from the quarter of neurologists and neurosurgeons. For instance, Joachim Gerlach, a Würzberg professor of neurology, objected to the equation of brain death and the personal death of a human being, as “makes the brain the ‘seat of the soul’ in a scientifically inadmissible manner. The competence of the person is not, according to Gerlach, “applicable in a scientific context”. Moreover, there are “no biological reasons for treating a part as the whole, as the existence of the whole presupposes the existence of all the parts.”40
    Even though the act of dying has increasingly been shifted from the domestic intra-familial stage to the hospital in the course of the twentieth century and has thereby been given strong medical connotations, and even though traditional death ceremonies have been upstaged as part of this development, modern culture has not really abandoned its metaphysical relationship to death.  The way we treat a corpse according to religious rules and to rules that, for some, still contain elements of magic can only be accounted for by ideas of a continued existence of the dead or of their souls (e.g. closing the eyes and the mouth, washing the corpse, funerary rituals, funeral, reception, etc.).  The current interest in the promotion of death related rituals, the rising anxiety about dying in a hospital, and the fears—reputedly irrational—engendered by transplantation medicine show the failure of attempts to radically secularize medicine. 
    The questions—and instinctive revulsion—that transplantation elicits could stimulate re-thinking of the philosophic assumptions behind the purely anatomic, mechanistic concept of a human being.41
    As we have seen, the issues facing medical doctors in the twenty-first century are numerous.  The fact that the Federal government is more of a hindrance to the medical profession than a help is unconscionable. These are not luxury items, but basic medical care.  It is certainly not surprising that many physicians would choose to opt-out of taking on additional Medicare patients; however, what does that mean for those Medicare patients who are in need of a physician?  Their options are even more limited than they were earlier. 
    Medicare is a valuable service for those who do not have any other option available to them; however, if someone has the resources or existing insurance plan they should be free to use their existing plan as they see fit.
    Issues such as patient confidentiality, transplantation, and the persistent vegetative state have a direct impact on patient care and the way that a given patient is treated while in the hospital.  No one wants to be considered a “human vegetable” for any reason, but particularly not because this person is determined to be “brain dead” based upon a definition which is questionable. 

                                                      End Notes

1)L.R. Huntoon “Abuse, Lies, and Audio Tape” Medical Sentinel 2000: 5(4):121
2)Robert Cihak and Michael A.Glueck “Medicare Destroying Patient-Doctor Trust” Medical Sentinel 2000:5(5)172,184
3)Jay Katz The Silent World of Doctor and Patient (MD: Johns Hopkins U. Press, 2002) p. xlv
4)William F. May The Physician’s Covenant: Images of the Healer in Medical Ethics (PA: The Westminster Press, 1983), p. 38
5)L.R. Huntoon “Pearls from the Third Party Patient” Journal of Amer. Physicians and Surgeons Vol. 11, No. 3, Fall 2006
6)Francis Peabody “The Care of the Patient88 Journal of the American Medical Association 877 (1927)
7)Gabrielle M. Kotoski declaration as part of a civil action Hall et al. v. Leavitt and Astrue  U.S. District Court: District of Columbia (12/2008)
8)Ilene N. Moore et al. “Confidentiality and Privacy in Health Care from the Patient’s Perspective: Does HIPAA Help?” Journal of Law Medicine Vol. 17:215, 2008, pp. 215-272 citing Judy Zelin, Annotation, Physician’s Tort Liability for Unauthorized Disclosure of Confidential Information About Patient, 48 A.L.R. 4TH 688, 679 (1986) (citing Humphers v. First Interstate Bank, 696 P. 2d. 527, 530 (plaintiff could proceed against physician’s estate under a breach of confidentiality claim but not an invasion of privacy claim). Cf., Horne v. Patton 287 S. 2d 824, 830-32 (1973) (allowing claims for both breach of confidentiality and invasion of privacy to go forward).
9)Moore et al. citing Lawrence O. Gostin, et al., Privacy and Security of Health Information in the Emerging Health Care System, 5 Health Matrix 1, 21 (1995), supra note 22, at 2 (“All participants … (consumers and patients, health plans, and federal and state regulatory agencies)…need access to high quality information for informed decision making.”)
10)Mark Siegler “Medical Confidentiality—A Decrepit ConceptNEJM, Vol. 307:1518-1521, December 9, 1982, No. 24
11)Moore et al, p. 226
12)Moore et al, citing C.F.R. § 160.101 (2003) (implementing sections 1171 through 1179 of the Social Security Act) 
13)Moore et al. citing Office of Civil Rights (OCR) Guidance explaining significant aspects of the Privacy Rule, supra note 3 at 41-42.
14)Richard Sobel “The HIPAA Paradox: The Privacy Rule That’s Not” Hastings Center Report 37, no. 4, (2007) pp. 41-44
15)Sobel, p. 42 citing Sec. 164.501, 506. The American Medical Association has long argued against issuing the broad definition of health care operations. See G. Aston “Pushed by a Looming Legislative Deadline, AMA Delegates Adopted New Policy on Patient Confidentiality Issues Tied to Participation in Medical Research,” American Medical News, July 12, 1999.
16)Sobel, p. 42.
17)Sobel, p. 42.  HIPAA creates rules for confidentiality (limitations of the range of records sharing, not privacy (patients’ control of information).
18)Sobel, p. 42
19)Sobel, p. 42 citing: For a discussion of the essential nature of confidentiality and consent for quality care, see the amicus briefs in Citizens and Althaus v. Cohen of the Program in Psychiatry and the Law at Harvard Medical School,
20)Sobel, p. 42 citing M. Doscher, HIPAA: A Short and Long Term Perspective on Health Care (Chicago, IL: American Medical Assn. Press, 2002), p. 90
21)Sobel, p. 42 citing “Eyes on Your Records” Consumer Reports, March 2005;  Also citing “The New Threat to Your Medical Privacy” Consumer Reports, March 2006, pp. 39 and 42
22)Carl E. Schneider, “HIPAA-cracyHastings Center Report, Jan.-Feb. 2006, pp.10-11
23)Sobel, p. 42
24)Sobel, p. 42
25)Rosamond Rhodes et al. (ed.) The Blackwell Guide to Medical Ethics (MA: Blackwell Publishing, 2007), p. 128
26)Lawrence O. Gostin Public Health Law: Power, Duty, Restraint (CA: University of California Press, 2008) p. 412
27)L.R. Huntoon “The Perilous Vegetative State” Journal of Amer. Physicians and Surgeons Vol. 10, No. 2, Summer 2005
28)Practical Parameters: Assessment and Management of Patients in the Persistent Vegetative State—report of the Quality Standards Subcommittee of the American Academy of Neurology, Neurology 1995:45:1015-1018
29)Editorial: The Vegetative State—Clinical Diagnosis Postgrad Med J 1999:75:321-324
30)J.T. Giacino et al. “The Minimally Conscious State: Definition and Diagnostic Criteria” Neurology 2002:58:349-353
31)C. Fischer et al. “Predictive Value of Sensory and Cognitive Evoked Potentials for Awakening from Coma” Neurology 2004:63:669-673
32)Eric J. Cassell The Healer’s Art (MA: MIT Press, 1995), p.99
33)Cassell, p. 112
34)Anna Bergmann (trans. by Otmar Binder) “Taboo Transgressions in Transplantation Medicine Journal of Amer. Physicians and Surgeons Vol. 13, No. 1, Summer 2008, pp. 52-55
35)J.F. Spittler “Der Himtod-Tod des Menschen, Grundlagen und medizinische Gosichtspunkte” Ethik in der Medizin 1995:7:127-145 (trans. by Otmar Binder)
36)Baureithal U. Bergmann Herzloser Tod Das Dilemma der Organspende Stuttgart:Klatt-Cotta, 1999,p. 48 (trans. by Otmar Binder)
37)Hans Jonas Technik, Medizin und Ethik Frankfurt am Main, Insel, 1987, p. 22
38)Ad Hoc Committee for Harvard Medical School to Examine the Definition of Brain Death: A Definition of Irreversible Coma, JAMA 1968:205:337-340
39)Anna Bergmann Der entseeite Patient. Die moderne Medizin und der Tod Berlin: Aufbau-Verfag, 2004, pp. 284ff (trans. by Otmar Binder)
40)J. Gerlach “Gehimtod und totaler Tod” Münchner medizinische Wochenschrill 1969:111:734
41)Bergmann “Taboo Transgressions”, p. 55


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