Ajmc DEC Rosenblatt 1525-1531


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Ajmc DEC Rosenblatt 1525-1531

  1. 1. . . . HEALTHCARE POLICY . . .Fairness and Rationing Implications of MedicalNecessity DecisionsLaurie Rosenblatt, MD; and Daniel G. Harwitz, MDAbstract patient advocate.1-4 In an attempt to address this con- When healthcare coverage entails medical neces- flict, payers have begun to explore external reviewsity review, patients, providers, payers, and govern- processes for patients denied coverage.5ment agencies must confront issues of fairness and Many questions arise when healthcare coveragerationing. To explore the ethical ramifications of requires medical necessity review. How should amedical necessity decisions, we provide 2 illustra- health maintenance organization (HMO) or at-risktive cases. In the first case, we discuss the implica- group decide about coverage for complex or specialtions of rule-based rationing and in the second we cases? How is a special case defined? Who makesconsider the influence of a medical group’s internal medical necessity decisions? What are the moralreview council on decisions of medical necessity. responsibilities of patients and their families, treat-Both case examples illustrate why there are no ing physicians, medical directors, and financialagreed-on rules for setting a threshold for approving administrators in these organizational settings?or denying care based on medical necessity and sug- Although rules may have a place in rationing deci-gest that more complex medical cases require a sions, they can never be specific or inclusive enoughmore complex review process. to capture the complexity of individual situations (Am J Manag Care 1999;5:1525-1531) and therefore cannot exclusively replace the profes- sional judgment of physicians.6-8 The existence of multiple and often conflicting doctrines is a fact of democratic society, and toleration of such variety is assumed to be of value. To explore the many issues related to medical necessity decisions, we provide o physicians and patients, many medicalT necessity decisions seem arbitrary and appear to be made more in response to liability andpublic relations issues than to considered clinical and two illustrative cases. . . . CASE 1: COVERAGE DENIED . . .ethical assessments. At the other extreme, “bedsiderationing” by primary care physicians is ad hoc and Mr. H. has ulcerative colitis and last had acan conflict with the physician’s ethical role as colonoscopy 1 year ago. He now returns to his pri- mary care physician complaining of gas and abdomi- nal pain. After examination and a negative Hemoccult test, the physician requests authorization From Harvard Medical School, Brigham and Woman’s to refer the patient to a gastroenterologist for possi-Hospital/Dana Farber Cancer Institute, Boston, MA (LR); and ble colonoscopy. The HMO referral coordinatorCleveland Clinic Florida Health Network, Fort Lauderdale, FL approves the consultation with the gastroenterolo-(DGH). gist based on the diagnosis of ulcerative colitis but Address correspondence to: Daniel G. Harwitz, MD, MedicalDirector, Cleveland Clinic Florida Health Network, 2900 West withholds preapproval of the colonoscopy. AfterCypress Creek Road, Suite 103, Fort Lauderdale, FL 33309. E-mail: evaluation, the gastroenterologist also requestsharwitd@ccf.org. authorization for the colonoscopy. Consulting theVOL. 5, NO. 12 THE AMERICAN JOURNAL OF MANAGED CARE 1525
  2. 2. ... HEALTHCARE POLICY ...Ambulatory Care Guidelines,9 the referral coordina- respect the nuances of medical illness, the complex-tor notes that colonoscopy is approved for ulcerative ities of medical knowledge, and the varying valuescolitis at less than 18-month intervals only when the that patients bring to decisions about their medicalfindings will affect clinical management. risk and benefits.8 Rule-based rationing might also The utilization review nurse contacts the gas- undermine medical professionalism, with treatingtroenterologist’s office and learns that there is no and authorizing physicians feeling absolved of moraldocumentation that would qualify Mr. H.’s responsibility for implementing rationing decisions.colonoscopy under the guideline requirements, and In the case of Mr. H., discussion between the med-she therefore denies authorization at this time. ical director and the gastroenterologist revealed noHaving already discussed with the patient his opin- compelling medical reason for performing theion that colonoscopy is indicated, the gastroenterol- colonoscopy earlier than dictated by the guidelines.ogist requests review by the HMO medical director. However, there are several possible patient-relatedAfter discussing the case with the gastroenterologist, reasons why the test was requested at this time.the medical director feels he must stand by his Mr. H. has experienced increased discomfort andguidelines, and he upholds the authorization denial. is worried about his condition. In response to Mr. When the physician learns that the medical H.’s anxiety and in the interest of building confi-director is not a gastroenterologist, he becomes dence with this new patient, the gastroenterologistangry, believing that care has been denied by a may have decided to order the test. By doing the testphysician lacking relevant specialty training who is now, a time-consuming follow-up visit might bebasing his decision on a “cookbook.” When the avoided, with its requisite additional referralpatient learns of the medical director’s decision requests and authorizations. Also, the gastroenterol-from the gastroenterologist, he feels the HMO is ogist might be concerned about malpractice, espe-withholding needed care solely to save money. cially because he does not have an established rela- tionship with the patient. Finally, if the patientDiscussion of Case 1 requests the colonoscopy, the specialist might not Both the gastroenterologist and the patient want to engage in a potentially long and perhapsbelieve that care has been denied by the HMO contentious discussion with a patient with whom hemedical director. The medical director, however, is may not establish an ongoing relationship.convinced that his denial of coverage does not con- The reasons for requesting the colonoscopy atstitute denial of care, and, as the professional inter- this time reflect physician-patient relationship fac-preter of what the policy should pay for, he believes tors rather than the narrow definition of medicalhe has properly done his job. necessity. Physicians with different approaches to The disagreement between the medical director patients and different levels of experience would beand the gastroenterologist stems directly from the expected to have different responses to Mr. H. Thusconflicting roles of the 2 physicians in a situation of authorization requests can stem from sources otherrule-based rationing.10 Each physician is seeking to than pure medical necessity. A test might be impor-uphold their obligation to practice ethical medicine tant primarily as a means of building trust or reliev-regardless of the system in which they function.10 ing a patient’s anxiety.The medical director has a fiduciary responsibility Rule-based rationing itself might have had a neg-to interpret coverage and to ensure that the patient ative effect on the gastroenterologist’s attitudereceives everything he is entitled to under the con- toward the colonoscopy. Hall8 and Mechanic16 havetract, but not more.11,12 The treating physician has both observed that the values of medical profession-fulfilled his responsibility to advise the patient of a alism are inconsistent with the imposition of exter-course of treatment without regard to cost,13,14 but nal rationing decisions and, as such, are universallyhe has not performed the additional “economic resented. Mr. H.’s gastroenterologist was trappedadvocacy” role15 required in the current healthcare between the historical directive to deliver unre-system. For example, the gastroenterologist could stricted resources to his patient and his inability toask Mr. H. if he wanted to pay for the colonoscopy do so in the face of an authorization denial. His frus-himself or he might suggest alternative diagnostic tration resulted in an unprofessional response andprocedures. an additional cost to Mr. H., his physicians, and the Imposing limits outside the physician-patient HMO.relationship raises the concern that rules will be Because most of the incurred costs are indirect, itapplied in uniform and categorical ways that do not is easy to overlook them. For example, by implying1526 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 1999
  3. 3. ... MEDICAL NECESSITY DECISIONS ...that the medical director is not competent to make interpersonal and operational issues clearly comea judgment regarding the colonoscopy, the gastroen- into play.terologist provoked Mr. H.’s distrust of the HMO, In a case such as this, competing ethical con-potentially undermining the patient’s continued straints create problems for the physician-patientcomfort with the care he receives from its providers. interaction and tensions between physicians andAs Morreim notes, “Physicians owe what is theirs to physician administrators. In unusual or special cir-give: their professional competence and loyalty as cumstances, interpersonal issues may become morealways and, in the new era of resource restrictions, important in medical authorizations for care. Intheir best efforts at advising and advocacy.”15 such cases, economic, ethical, interpersonal, andAdvising and advocacy represents an evolution in social issues interact and often conflict. The relativemedical professionalism and requires a new under- weight of these concerns in the overall decisionstanding of the limits of what can be promised in the regarding services can vary by organization, patient,physician-patient visit. Physicians now have a moral and patient situation, as illustrated in the next case.responsibility to engage in advocacy when autho-rization decisions are considered harmful to patientcare. . . . CASE 2: COVERAGE APPROVED . . . The patient’s responsibilities must also be consid-ered. In effect, Mr. H. made a rationing decision for Ms. C., a member of a Medicare risk-contractedhimself by choosing an HMO as his provider. He medical group, has multiple medical conditions,chose what portion of his income he is willing and including serious heart disease and an enlargingable to expend on health benefits. By choosing an abdominal aortic aneurysm. The group’s medicalHMO, he consented to rules governing or limiting his director authorizes evaluation of Ms. C. by a vascu-access to certain procedures. However, this is true lar surgeon and a cardiologist. They report to heronly if Mr. H. had more than one choice of insurance primary care physician that although she would ben-plan if he obtains coverage through his employer and efit from repair of her aneurysm, the risk of surgeryif he was provided accurate and complete informa- is too great. The vascular surgeon then discussestion about his benefits. with Ms. C. the possibility of a new procedure Our point here is that each of these issues carries (endostent) that may prolong her life. Ms. C. returnsvalue and cost. The most easily measured cost is the to her primary care physician to discuss her optionsdollar price tag of the colonoscopy. The costs of and requests authorization for the endostent proce-administrative time to obtain a second visit are indi- dure. Her primary care physician refers the requestrect. The relationship cost if the gastroenterologist is to the group’s medical director, who discovers thatunable to find another way to build trust with Mr. H. the endostent procedure is investigational andcan lead to expensive “doctor shopping” or even therefore not covered by the contract. In addition,“HMO hopping,” as well as low physician morale and the medical group does not have the expertise tostaff burnout. Each organization is likely to assess its perform this procedure.willingness to confront each of these costs different- The group’s medical director believes the patient’sly, according to a perception of their needs at the situation will need to go before the group’s managedtime. For consumers, it may become part of their care review council based on the strong convictionsinformed healthcare buying to evaluate insurers of Ms. C.’s treating physicians. The medical directorbased on their approaches to such issues. identifies the interventional radiologist who per- In the case of authorization for the colonoscopy, forms the endostent procedure and requests pricethe medical director acted based on his responsibil- information. The radiologist refers the medicality for husbanding the resources of the organization director to the outside hospital’s contracting officerand used a population-based ethic for his judgment. who advises him that because of a lack of guaranteedThe gastroenterologist made decisions based solely volume, the best price she can offer is a discount ofon his judgment concerning the needs of his 15% from customary charges. The medical directorpatient, including the need to build the physician- discovers that the radiologist and hospital are par-patient relationship, as well as pragmatic concerns ticipating providers with the HMO and are contract-regarding office and procedure scheduling.17 The ed at 80% of Medicare allowable, substantially lessconsequences to Mr. H.’s health are not severe than the offered rate of customary charges less 15%.enough to engage a non–rule-based process (such as The medical director’s negotiations bring the cost ofthe process described in the next case), although the procedure into an arguable range. After discus-VOL. 5, NO. 12 THE AMERICAN JOURNAL OF MANAGED CARE 1527
  4. 4. ... HEALTHCARE POLICY ...sion, the group’s managed care review council our current social values but that could eventuallyauthorizes the investigational procedure even change over time.though it is not covered, because it is Ms. C.’s best In this case, Ms. C.’s physicians believe that thehope for life-prolonging treatment. investigational procedure is her best option and To obtain the HMO’s favorable rates, the group’s because she is interested in the treatment, theymedical director contacts the HMO’s medical direc- advocate for coverage under the group’s risk con-tor to arrange authorization through the HMO. The tract. Although a medical director tempers the rulesHMO medical director points out that investigation- for coverage decisions with his or her full medicalal procedures are excluded from coverage, and he experience and empathy, sometimes a patient’s situ-cannot authorize this service. The medical director ation presents issues that overreach the rules andof the provider group explains that it is the group’s warrant a different process. To answer the secondrisk-contracted money that will pay for the proce- question posed by Aaron,6 the medical director refersdure. Although concerned about setting a precedent, Ms. C.’s case to the group’s managed care reviewthe HMO medical director issues the authorization, process. Ms. C.’s at-risk group had previously agreedand Ms. C. undergoes the endostent procedure. to discuss complex utilization issues in their man- aged care policy-making body, a council composed ofDiscussion of Case 2 a variety of professionals, all of whom are salaried Ms. C., her treating physicians, and the medical and receive no bonuses or incentive payments.group at risk for the cost of her care are facing 2 Although the financial conflict of interest is lessquestions posed by Aaron: “The first is simply one direct than it would be under different reimburse-of identifying when extension of life is beneficial; ment arrangements, the medical group’s financialthe second is a question of whether therapies well-being is the direct responsibility of some mem-acknowledged to be beneficial are worth the cost.”6 bers and in the interest of all. By including partici-Approaching the situation from Aaron’s perspec- pants with varying ethical responsibilities, expertise,tive, Ms. C. and her treating physicians have iden- and objectives on the review council, the medicaltified the procedure as likely to extend her life and group hoped a fair judgment could be arrived at inas her most prudent option for care. Ms. C. has the cases discussed. Also, creative solutions to eachsaid she is interested in pursuing the endostent case were expected to emerge from these discus-procedure but cannot afford to pay for it herself. sions. In real life, self-interest cannot be hiddenThus the first decision, the patient’s own assess- behind a veil of ignorance,20 but with the properment of her best interest, has been answered in the structure and procedure it can be accorded lessaffirmative. power.21 (Although rotating committee membership There is no agreed-on, ethically superior method would have provided training in the deliberativeof managing last-chance therapies (experimental or method and a broader representative function, thenot) that are not covered by a patient’s policy. The managed care review council’s status as an organi-question has been raised, in an intuitive way, zational experiment led to non-rotating initial mem-whether potentially life-saving treatments have spe- bership. Thus one of the possible limitations facedcial status and value.7,18 Nord et al18 and Hansson et by the review council was entrenchment of poweral7 have found that across cultures there are simi- and evolution of subtle group-held prejudices.larities and differences in the way people prioritize Involving treating physicians in the presentationthe use of limited healthcare resources in hypothet- and discussion of cases provides some oversight andical situations. Daniels19 points out that in facing a link to the wider group community.)rationing decisions in which the benefits are not Making decisions through the deliberationdivisible in an equal way and competing individuals process used in this case has some disadvantages,have plausible claims in principle, intuition plays a the most obvious of which is the potential for appar-role in what ultimately “feels” fair. He notes that we ently inconsistent results. The review councilhave a less-developed sense of individual to aggre- process clearly does not eliminate the possibility ofgate comparisons than we do regarding decisions injustice, but once a fair decision-making procedurebetween 2 individual situations. Given the cross-cul- can be agreed on, the results may be fair enough22,23tural differences, the individualistic values of the or the decision makers might at least have some flex-United States, and the dramatic human appeal of ibility, which guarantees a more just outcome thanlast-chance therapies, there may be some subtle pri- does the imposition of rule-based rationing. The con-ority placed on such treatments that is in line with sistency and objectivity of rules sacrifices the values1528 THE AMERICAN JOURNAL OF MANAGED CARE DECEMBER 1999
  5. 5. ... MEDICAL NECESSITY DECISIONS ...of individuality and accuracy in complex situations, mental grant and the outside hospital, and he lowerspotentially undermining the fairness of decisions. In the final hard dollar cost to the medical group. Forsimple authorization decisions, such as that of Mr. H. the group, this represents a cost shifting from thein the preceding case, the value of objectivity often direct cost of services to the indirect cost of over-outweighs concerns for specificity (a trade-off between head (the nonreimbursable administrative salary ofconsistency and singularity). However, in authoriza- the medical director). Because for-profit and not-tion decisions regarding treatment for life-threaten- for-profit healthcare organizations compete in theing conditions, these values of objectivity and current healthcare market, the cost of educatingspecificity may interact and conflict.6,24 healthcare providers, testing new therapies, and Goold21 raises several questions that reflect on conducting research can become a competitive dis-the effectiveness of the review council process. Was advantage to organizations performing these sociallythe decision based on a reasoned deliberation about valuable functions. In Ms. C.’s case, the medicalthe best use of available resources reflecting a group has taken on responsibility for some of thesegreater value placed on life-saving treatment or was costs in an indirect way, not only in the expenditureit a sympathetic response to a fellow human’s plight, of the medical director’s time but also in the generalmore reflective of the greater psychologic weight of value placed on research and education in academ-the individual life over the statistical life? Has the ic group practices. In many HMOs, the question ofneed to restrain the use of resources been main- treating Ms. C. might not even have arisen, eithertained or have the limitations become abstract com- because of different values or lack of informationpared with an individual’s identifiable need? Have about available experimental treatments.the physicians on the council, in the guise of taking The presence at the council meeting of Ms. C.’sthe moral high road, found a way to “game” the treating physicians provides the council membersinsurance contract (even at a cost to their group), with expertise and the treating physicians with aexpressing their frustration in the face of decreasing procedure for patient advocacy in special situations.control over unexamined access to medical In addition to making the decision process explicitresources on behalf of their patients? (thereby reinforcing accountability), this arrange- The question of the best use of resources runs ment models the engagement of professional andinto immediate problems. As Benjamin and others organizational values in medical necessity decisionpoint out,6,25,26 the US healthcare system is an open making, creating a shared value base on which indi-one, functioning without a definite budget. This vidual physicians can build when facing bedsidemakes it more difficult to say no to care that is cost- rationing decisions. Ms. C.’s treating physicians arely and marginally beneficial because it is not clear at the council meeting for the express purpose ofthat resources withheld from one patient actually go sharing the moral responsibility for rationing deci-to another who is more rationally selected. sions. Their presence ensures that the council mem-(Benjamin denies we ration, stating we irrationally bers cannot feign unawareness of the real stakes forallocate rather than ration.25) So if the group’s Ms. C. and that her treating physicians cannotreview council elects to withhold treatment from Ms. blame abstract “others” for decisions denyingC., what guarantee do they have that the saved coverage.resources will benefit a needier patient? If the The medical group review process has as its con-review council is composed of academic highly spe- stituency both the group’s physicians and the cov-cialized physicians, they value research and support ered patients. Through this review process, thecolleagues involved in research. Their knowledge medical group attempts to preserve fairness and toand values might influence their willingness to con- support physician morale and professionalism bysider covering experimental treatments and actually reinforcing the importance of physician advocacy inundermine concepts of distributive justice based on medical necessity decisions. When the review coun-utilitarian ideals. cil process works, it undermines regressive and In this case, the medical director has already nihilistic concerns on the part of patients and physi-expended group resources (in the form of his time) cians, concerns that they will always be refusedto find the most cost-efficient way of obtaining ser- access to expensive services. The review processvices, should they be authorized. By discovering the also undermines a belief that there are needlessHMO contracted rates with the hospital and directly obstacles to care. The conviction that the system orcommunicating with the interventional radiologist, HMO is “gaming the patient” (taking unfair advan-he can shift more of the direct cost onto the experi- tage of the patient by exploiting ambiguity and flex-VOL. 5, NO. 12 THE AMERICAN JOURNAL OF MANAGED CARE 1529
  6. 6. ... HEALTHCARE POLICY ...ibility in the rules) can pressure physicians to bend organizations facing escalating medical demandthe rules and circumvent restrictions.15 but limited financial resources. The value to society In care decisions that are potentially onerous, a of medical education and research comes into playmedical group’s review council ensures that a in many medical necessity decisions, along with thepainful judgment will not fall on a single physician question of who pays.and negates any tendency on the part of the treating We have discussed 2 cases here, one in whichphysicians to abrogate their moral accountability to rule-based rationing may be fair enough and a sec-their patients. The review council also prevents ond in which a review council process is initiated inphysicians from potentially shirking their moral recognition of the higher stakes and greater com-responsibility to patients in situations in which the plexity of the situation. The allocation decisionsphysicians become enforcers of rationing decisions made by a review council act as “considered moralmade by absent and faceless others. It also prevents judgments,”20 informed by the principles used todecision makers from becoming too distant from the arrive at them. The questions posed by Ms. C.’s casepatient and thereby avoiding the full human impact cannot be fully answered but stand as self-queriesof their judgments. In the collegial atmosphere of for evaluating the effectiveness and fairness of thethe group, physicians share moral responsibility for review process.costly resource allocation decisions (costly in termsof money or life) but do not escape from the ethicalresponsibilities of their role. . . . REFERENCES . . . . . . CONCLUSION . . . 1. Rosner F. The ethics of managed care. Mt Sinai J Med 1997;64:8-19. In decisions regarding medical necessity, uncer- 2. Thomasma DC. The ethics of managed care: Challenges totainty is a constant. Patients have individual med- the principles of relationship-centered care. J Allied Health Summer 1996:233-246.ical conditions and unique wishes and values 3. Warner EG. Ethics and morality vs managed care. Ohioregarding their treatment. Physicians also have State Med Assoc 1996;89:275-279.unique values, both personal and professional. 4. Bell H. Managed care ethics: A delicate balance. MinnOrganizations have specific missions and financial Med 1996;79:11-16.responsibilities to their boards and stockholders. 5. Jeffrey N. Aetna to set national review plan for HMO sub-Consequently, our current healthcare delivery sys- scribers denied coverage. Wall Street Journal. January 12,tem is an arena of conflicting values, primarily 1999:B6.between business ethics and the traditional ethics of 6. Aaron HJ. Questioning the cost of biomedical research.medical care. The businesses that own healthcare’s Health Aff 1986;5(2):96-99.resources sometimes are seen as intruders in the 7. 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  7. 7. ... MEDICAL NECESSITY DECISIONS ...16. Mechanic D. Rationing of medical care and the preserva- 22. Fleck LM. A democratic decision-making approach.tion of clinical judgment. J Fam Pract 1980;11:431-433. University P Law Rev 1992;140:1579-1638.17. Sabin JE, Forrow L, Daniels N. Clarifying the concept of 23. Miles SH, Koepp R. Comments on the AMA report ethicalmedical necessity. Med Interface December 1991:35-42. issues in managed care. J Clin Ethics 1995;6:306-311.18. Nord E, Erik, Richardson J, Street A, Kuhse H, Singer P. 24. Daniels N, Sabin JE. Last chance therapies and managedMaximizing health benefits vs egalitarianism: An Australian care: Pluralism, fair procedures, and legitimacy. Hastings Centsurvey of health issues. Soc Sci Med 1995;41:1429-1437. Rep 1998;28:27-41.19. Daniels N. Meeting the challenges of justice and 25. Benjamin M, Cohen C, Gruchowski E. What transplanta-rationing: Four unsolved rationing problems: A challenge. tion can teach us about health care reform. N Engl J MedHastings Cent Rep 1994;24:27-29. 1994;330:858-860.20. Rawls J. A Theory of Justice. Cambridge, MA: Harvard 26. Braithwaite SS. Distributive justice: Must we say yes whenUniversity Press; 1971. society says no? In: Monagle JF, Thomasma DC, eds.21. Goold SD. Allocating health care: Cost-utility analysis, Healthcare Ethics: Critical Issues. Gaithersburg, MD: Aspeninformed democratic decision-making, or the veil of igno- Publishers; 1994:295-304.rance? J Health Polit Policy Law 1996;21:69-98.VOL. 5, NO. 12 THE AMERICAN JOURNAL OF MANAGED CARE 1531