The Journal of Law, Medicine 6 Ethics

hospital responded by stating that al- though it was trying to retrieve the re- quested information, they were not required to prepare the reports. After- ward, the Vice President of Legal Af- fairs and General Counsel for the hos- pital told the Petitioner that the docu- ments requested were “exempt from public disclosure pursuant to the medi- cal records exemption found in OCGA 5 50-18-72(a)(2)”.3 The Petitioner filed for writ of mandamus to compel the hospital to turn over the records. Respondent moved for summary judg- ment claiming that they were not re- quired to turn over the records because doing so would force them to compile information and require the hospital to audit its Medicare accounts in vio- lation of OCGA S 50-18-72(d). The trial court denied the petitioner’s re- quest, holding that the petitioner failed to prove that the requested documents were, in fact, public record^.^

On review, this court stated that the purpose of the Act is to make ex- isting records and documents available to the public, not to give public offic- ers or agencies custody of things that do not exist.’ The term “public record” includes “all documents, pa- pers, . . . computer based or generated information, or similar material pre- pared and maintained or received in the course of the operation of a public office or agency”.6 However, the stat- ute specifically states that no agency will be required to prepare such records if they do not exist at the time of the request.’ It is not within the legisla- tive intent to require an affirmative duty to compile such records.8 The hospital produced significant evidence to demonstrate that the information requested was not compiled, and was stored on microfiche, making collec- tion and compilation of this material extremely time consuming and burden- some. The Act does not require a hos- pital to compile computer information. Based on the evidence, the court con- cludes that the information did not constitute an existing “public record” and non-disclosure of the information

was not a violation of OCGA.9 The petitioner further contended

that the right of non-disclosure was waived because the hospital did not notify them of the denial of the records in writing. However, the court held that failure to furnish something that does not exist is not a violation of the Act.‘O Mandamus is appropriate if the petitioner has a clear right to the rem- edy sought. It would be inappropriate here, however, because petitioner had not demonstrated such a definite legal right to relief.”

The industry as a whole may be affected by this decision because no hospital, at least in Georgia, will be required to turn over their information and private records unless they keep a database of all the information readily compiled. This may prompt hospitals to be less organized in their record keeping and cause plaintiffs to be un- able to access records that may be needed in various legal actions.

Randi Burnstine

References

1. 2000 WL 1275289 (Ga.) 2. See id. at *1. 3. Id. 4. Id. 5 . See Zinngrabe v. School Dist. Of

Sevastopol, 431 N.W.2d 734, 736 (WkApp. 1988).

6. OCGA § 50-18-70(a). 7. See OCGA § 50-18-70(d). 8. Felker v. Lukemire, 477 S.E.2d 23

9. See Schulten, Ward & Turner, 2000 (1996).

WL 1275289 at *1. 10. See id. at *2. 11. Id.

Policy: Kaiser Commis- sion Report on Personal Perspectives

Anecdotal examples are frequently used to illuminate important health- care policy issues. Prominent legislators and policy makers often rely upon per- sonal accounts when deciding between various statutory and resource-alloca-

tion remedies for the problems facing the American health-care system. Dur- ing the first presidential election de- bate, held in Boston on October 3 , Vice President Al Gore related the experi- ence of George McKinney of Milwau- kee to illustrate a key difference be- tween his prescription drug plan and that of Texas Governor George W Bush. According to the vice president, the 70-year-old McKinney is forced to travel to Canada to purchase prescrip- tion drugs due to personal budgetary constraints. Gore punctuated the tale by claiming his prescription drug plan would offer McKinney more immedi- ate relief than the plan proposed by Bush.

Despite the compelling nature of personal stories, decision-makers must still verify their representativeness, as the decisions they inform will impact not only one person or family, but a multitude of people. In a widely fol- lowed presidential debate, the candi- dates have considerable incentive to address the concerns of the maximum number of potential voters. Similarly, when deciding matters of health legis- lation and policy, those responsible for ensuring adequate health care in soci- ety must ascertain what pressing issues and problems affect the greatest num- ber of people. While personal accounts add a level of reality that statistics do not readily convey, legislators and policy makers, in addition to presiden- tial candidates, need to ensure that the anecdotal accounts they relate repre- sent larger, more widespread problems.

A recent report released by the Kaiser Commission on Medicaid and the Uninsured achieves a useful syn- thesis between statistics and personal accounts.’ By presenting relevant data from nationwide studies alongside its descriptions of uninsured families, the report paints a vivid picture of several problems facing the nation’s 44 mil- lion uninsured individuals? In total, the report recounts some of the challenges of seven families and an individual- the Paffords, Zamoras, Nelsons, Smiths, Combses, Mendivils, Taylors,

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Volume 28:3, Fall 2000

and Ms. Olden-in obtaining health care, given their uninsured status. While it may not present the typical health-care administrator with new fig- ures regarding the uninsured, the Kai- ser report does shed significant light upon the reasons people, uninsured and insured alike, do not receive ap- propriate health care. Additionally, a study such as this one, comprised pri- marily of personal accounts, may of- fer policy makers insight into poten- tial solutions for these insufficiencies.

One of the notable patterns that emerges with each of the uninsured families interviewed is that at least one of the members works full time. This underscores the widely unknown fact that employed individuals and their family members comprise the major- ity of uninsureds. Like all those inter- viewed in the Kaiser report, 74 per- cent of uninsureds come from families with at least one full-time ~ o r k e r . ~ Pre- cise reasons such a large number of people supported by a source of in- come go uninsured are difficult to quantify due to diverse underlying motivations. Although the common concern of the report’s interviewees is budgetary constraints, perspectives on health care differ widely, from the view of the Mendivils that out-of-pocket health-care payments are cheaper than insurance,4 to that of Shannon Combs, who recounts her struggle through fre- quent bureaucratic delays to obtain prenatal care under a state-paid health insurance programs

Fortunately, for the first time in 10 years, the number of uninsureds has dropped, largely due to the ability of small-firm employers in a robust economy to keep up with the rising costs of health care.6 Still, problems such as those experienced by the Paffords of Virginia persist, despite the decline in the number of uninsureds that one consumer advocacy group leader calls “a morning drizzle after a prolonged drough.’” Tom Pafford, the only member of the family covered by his employer’s health-care package, often feels reluctant to seek out appro-

priate medical care due to feelings of guilt.8 This hesitation to take full ad- vantage of available health care may be indicative of a widespread sentiment and should inform lawmakers’ efforts.

Recent developments in the Children’s Health Insurance Program (CHIP) reflect the families’ experiences and perhaps support the position that entire families, not just individual mem- bers, should receive coverage under this plan. In the case of the Paffords, when insurance covers only one member of the family, the health-care needs even for that person are not necessarily met. Similarly, many families that are eligible for CHIP do not enroll because the program targets children only and does not address the entire family’s need for health-care benefits. This situation resonates with several key congres- sional legislators, such as Senator Ed- ward Kennedy of Massachusetts, who is one of the primary proponents of expanding the CHIP program qualifi- cations to include the parents or care- takers of children in need of health- care c~verage.~

Broadening the CHIP program makes sense in light of the fact that $1.9 billion of federal money targeted to- ward providing children with health insurance had gone unspent as of the end of September 2000.10 The unspent money from allotments to 40 states will now be redistributed to the 10 states that did spend their entire allotment. In addition to reluctance by families to apply due to the lack of comprehen- sive family coverage, several other fac- tors explain the failure to allocate and distribute these funds.

The experiences of the Taylors,” a family of three from Oklahoma, gives some insight into how states that have lost CHIP money in this three-year dis- tribution period might alter their poli- cies to keep the money in their own states. Unable to apply for these funds due to a relatively low income limit for Oklahoma’s version of CHIP, the Taylors did not qualify for money that will ultimately be given to other states, such as neighboring Missouri, where

the income limit for CHIP program qualification is considerably higher. The effective result is that the state that spends more money not only retains its CHIP benefits, but also receives more, at the expense of states that do not allocate and distribute in a timely manner. Thus, in examining the ob- stacles preventing the appropriate dis- tribution of these funds, legislators from the 40 states that lost their fed- eral money may discover solutions by looking to families like the Taylors.

Reading through these interviews, lawmakers and administrators might also be struck by the substantial role that the attitudes toward subsidized health care and social stigmatization play in preventing individuals from gaining access to health-care coverage. These barriers inevitably present the most difficult problems for legislators, who are hard-pressed to find ways to change attitudes through the enact- ment of policy and law. In addition, the ability to obtain health care differs widely, as seen among the eight groups of interviewees, making a widespread remedy for this problem more com- plicated. Personal initiative does appear to make a considerable difference in securing access to health care. The re- peated and, in the end, successful, ef- forts by Shannon Combs to obtain pre- natal health care stand in contrast to the belief of several other interviewees that the amount of bureaucracy and other factors were simply too over- whelming.

Here, proponents for and against expansion of public-sponsored health- care initiatives can claim support for their respective stances. The former might argue that since many people feel too ashamed, lack sufficient initiative, or simply do not have the means to seek out and obtain state-sponsored health care, more resources should go into outreach efforts. The latter would argue that it is not the government’s role to lead people in need of services to those services. It is enough that the government provide the services in the first place; additional efforts would be

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The Journal of Law, Medicine t9 Ethics

an inefficient use of time and resources. In this and several other issues that arise throughout the Kaiser report, pro- posed remedies are easily subject to debate.

Yet regardless of one’s interpreta- tions of the lessons gleaned from it, the Kaiser report represents a significant tool for informing public policy and legislative decisions. Those with a vested interest in providing health care to society are well-served by giving it a critical reading and arriving at their own conclusions. Certainly, for many of the hardships experienced by those lacking health insurance, the remedies are neither obvious nor facile. It will require the efforts of health-care pro- viders, policy makers, legislators, and recipients alike to ensure the health of all members of society. At the very least, by beginning with studies like this one and encouraging more like it, all those involved can work with a common understanding of the real experiences of citizens without health insurance.

Darcy Paul

References

1. M . Shirk (Kaiser Commission on Medicaidand the Uninsured), In Their Own Words: The Uninsured Talk About Living Without Health Insurance (Washington, D.C.: Henry J. Kaiser Family Foundation, 2000) (visited November 22,2000) 4 t tp : l Iwww. kfiorglcontent12000l22071~.

2. Recently released census figures have this numberdeclining, for the first time in a decade, to 42.6 million. R. Peal; “Num- buof Insured Americans Is Up for First lime Since ’87,”New York Xmes, September28 2000, at A1 6.

3. Shirk, supra note 1, at 3. 4. Id., at 32-37. 5. Id., at 26-3 1. 6. Pear, supra note 2, at A16. 7. R.E Pollack, executive director of

Families USA, quoted in Pear, supra note 2, at A16.

8. Shirk, supra note I, at 7. 9. Pear, supra note 2, at A1 6.

10. R. Pear, “40 States Forfeit Health Care for Poor Children, ” New York Times, September24, 2000, at 1.1.

11. Shirk, supra note 1, at 38-43.

Medicare: Coverage Approved for Participa- tion in Clinical Trials The Health Care Financing Adminis- tration (HCFA) issued a final national coverage decision approving Medicare coverage of the routine health care costs for beneficiaries involved in clini- cal trials.’ The decision marks the implementation of President Clinton’s July, 2000 directive to the Department of Health and Human Services to pro- mote actively the participation of Medicare beneficiaries in clinical trials for all diseasesz

The decision defines routine costs in clinical trials as “all items and ser- vices that are otherwise generally avail- able to Medicare beneficiaries. . . that are provided in either the experimen- tal or the control arms of a clinical trial.”3 Routine costs include all the items or services typically provided absent a clinical trial, including the items and services needed to adminis- ter or monitor the investigational item or service, and the items or services required for the reasonable and neces- sary care used to diagnose or treat com- plications arising from participation in a clinical trial. However, Medicare will not cover the actual investigational item or service being tested, nor items and services used solely to satisfy the data collection requirements of the trial. Further, the routine costs provi- sion does not include the coverage of items or services that research spon- sors customarily provide free of charge to trials participants. For example, Medicare will pay to administer a che- motherapy drug that is being tested in a trial, as well as anti-nausea drugs to prevent associated complications and room and board as part of a required hospital stay. But Medicare will not pay for the chemotherapy drug i t~e l f .~

Some clinical trials qualify auto- matically to receive Medicare coverage of routine costs. These include trials funded by the National Institutes of Health, the Centers for Disease Con-

trol and Prevention, HCFA, the Agency for Healthcare Research and Quality, the Department of Defense, the De- partment of Veterans Affairs, and tri- als conducted under an Investigational New Drug application approved by the Food and Drug Administration.

To ensure the safety of Medicare beneficiaries in clinical trials that do not automatically qualify for coverage, the HCFA decision establishes a process to determine which clinical trials are eli- gible for its participants to receive pay- ments for routine medical costs. In order to be approved for Medicare coverage, a clinical trial must satisfy three primary requirements. The trial’s purpose must first be the evaluation of an item that falls within a Medicare benefit category. Second, the trial must have a therapeutic intent, rather than an exclusive purpose of testing tox- icity. The final requirement limits therapeutic interventions trials to patients with diagnosed disease rather than healthy volunteers, but allows diagnostic intervention trials to enroll healthy patients for control group purposes.

In addition to meeting the initial criteria, HCFA requires a clinical trial to have certain identified desirable characteristics. To qualify, the trial must have a purpose of testing whether the intervention improves the partici- pants’ health outcomes, must be scien- tifically and medically supported, and must not unjustifiably duplicate exist- ing studies. Further, the trial must be appropriately designed to answer the research question posed, must have credible and capable sponsorship, and must be conducted consistent with human subject protection regulations and the standards of scientific integ- rity. The decision mandates the Agency for Healthcare Research and Quality to create a multi-agency Fed- eral panel to “develop qualifying cri- teria that will indicate a strong pos- sibility that a trial exhibits the[se] desirable characteristics. . . .’lS

The coverage decision will signifi- cantly encourage Medicare beneficia-

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