The right of a physician to use a medical device for other than its approved application may receive a definitive test in a case in which the FDA's Center for Devices and Radiological Health (CDRH) has filed a complaint against LaserVision Centers (St. Louis, Missouri). The CDRH has served the company with an administrative complaint, along with a notice of opportunity for hearing, for unapproved uses of its laser systems up to 1998. The CDRH is seeking civil penalties from LaserVision and four of its executives of amounts not to exceed $1 million each. John Stiles, head of investor relations for LaserVision, told The BBI Newsletter that the dispute is "a practice of medicine" issue, meaning that the company believes that physicians have the right to carry out unapproved procedures with the company's lasers, based on good medical judgment.

As reported by BBI's sister publication, Medical Device Week (see April 13, 2000 issue), such unapproved – or "off-label" – uses of devices and drugs remains a murky issue despite last year's federal court ruling prohibiting such uses as unconstitutional. The complaint involving LaserVision relates to a subpoena regarding the company's prior-use software, termed "international cards," enabling LaserVision's excimer lasers to be used to perform eye surgeries for higher myopia cases (greater than -6.0 diopters) than those initially approved by the FDA. According to LaserVision, the subpoena is "part of an industry-wide investigation into the use of international cards prior to the FDA's approval of the use of excimer lasers for higher myopia cases." It went on to say that it "does not know if any other companies or individuals have been served with similar complaints."

Bob May, general counsel for LaserVision, told BBI that the complaint is "sort of analogous to a lawsuit – a judicial proceeding" and that it would ultimately be decided by an administrative law judge. He added that it is the type of case that "could drag on for years." The company had 30 days to reply to the complaint and May said that there will be "other opportunities for discovery." Backed by strong opinion in the medical community, ophthalmologists have taken the position that FDA restrictions on use of laser equipment through software control – rather than the traditional means of labeling – deny any flexibility in treating individual patients in a way that is medically necessary. And the company termed the restrictions "an unwarranted intrusion" on the ability to exercise that judgment. Currently, ophthalmologists routinely treat patients with high myopia (greater than -10.0 diopters), and the FDA now allows eye surgeons to exceed its approved parameters. LaserVision said that neither it "nor any of the hundreds of other users of excimer lasers in America

have used international cards since early 1998."

Responses seek beefed-up medical privacy

How large is the problem of medical privacy? If responses to that question are any indication, it is very large. Janet Heinrich, associate director of health financing and public health issues at the General Accounting Office (GAO), recently told the Senate Health, Education, Labor and Pensions Committee that the GAO has received 52.000 comments on proposed new regulations of medical privacy, none of them saying better privacy protections are unnecessary. These responses included "a lot of anecdotal information [indicating] that it is quite easy for people who don't have the best interest of the patient in mind to gain access to private medical information," Heinrich said. The flood of responses came from patient and physician groups, insurance organizations, the pharmaceutical and biotechnology industry, and physician groups, she noted.

With a statutory deadline long since passed and bipartisan legislation stalled, the Senate committee has held at least eight meetings to look at the issues surrounding the privacy of medical records. For the most recent session, Committee Chair Sen. Jim Jeffords (R-Vermont) convened a panel of experts and stakeholders in response to the GAO's report examining the privacy regulations proposed by Health and Human Service Secretary Donna Shalala, as well as the deluge of input about those regulations. "There was widespread acknowledgement, despite the organizations' diverse perspectives, of the importance of protecting the privacy of medical records," Heinrich said. "The fundamental differences among the groups' positions reflect the conflicts that sometimes arise between privacy and other objectives."

Issued in November, new regulations became necessary when Congress failed to pass comprehensive medical privacy legislation by an Aug. 21, 1999, deadline. That deadline was set when congress enacted the Health Insurance Portability and Accountability Act (HIPAA) of 1996. But as a result of congressional inaction, Shalala was required to promulgate regulations to protect the privacy of electronic medical records. In order to expand those protections found in the proposed regulation of paper-based medical records, new legislation must be enacted. Jeffords, and Sens. Christopher Dodd (D-Connecticut), Edward Kennedy (D-Massachusetts) and Bill Frist (R-Tennessee) have been working on creating bipartisan medical privacy legislation. However, the proposal has been hung up by disagreements over the privacy rights of minors and the right to sue when confidential medical information is misused. Despite the committee's failure thus far, several of the hearing's witnesses encouraged them to push ahead.

"We urge you to put medical privacy legislation back on your agenda," said Kathy Farmer, manager of U.S. compensation and benefits at Hewlett Packard (Palo Alto, California). "Many of the shortfalls of HHS' privacy rule cannot be addressed by revisions to this rule because the agency has only limited statutory authority." Farmer also cited the failure of the HHS regulations to preempt state privacy laws. However, Greg Koski, associate professor of anesthesia and critical care medicine at Massachusetts General Hospital (Boston, Massachusetts), said the privacy regulations do not need this preemptive ability. And he maintained that enhanced privacy protections would spur research, not inhibit it. Many "will decry enhanced privacy" and claim "stronger privacy protections will make it impossible to do research. In fact, the exact opposite is true," he said. But, he added, "As biomedical research increasingly depends upon access to more personal health information – such as genetic information – society will demand that privacy protections be strengthened, and if we fail to meet those expectations, we will find that the credibility of our research endeavors are further undermined."

GAO: HCFA, Medicare need restructuring

Medicare is an inherently difficult program to manage, regardless of how it is structured, the General Accounting Office concluded last month in tackling another large national health care issue. But while pointing to problems that impair Medicare's ability to operate more efficiently, it said that these problems can be remedied. As just one example of a change needed, the GAO cited the lack of a senior official focusing solely on Medicare at the Health Care Financing Administration (HCFA; Baltimore, Maryland), the agency responsible for managing the program. Rather, the HCFA Administrator must oversee Medicaid and other state programs as well. And the GAO noted, "Frequent changes in HCFA leadership [which] have inhibited the implementation of long-term Medicare initiatives or the pursuit of a consistent management strategy." In fact, in the 23 years since HCFA's inception, there have been 17 administrators or acting administrators with less than one year of tenure.

The GAO also cited constraints on HCFA's ability to acquire appropriate resources and expertise, thus hampering its ability to modernize Medicare and carry out the program's growing responsibilities. "Relative to the size of private health insurers and their administrative budgets, HCFA runs Medicare on a shoestring," the GAO said. "Too great a mismatch between the agency's administrative capacity and its designated mandate could leave HCFA unprepared to handle Medicare's future population growth and medical technology advances." Congress recently added an array of new tasks to HCFA's existing responsibilities through the Balanced Budget Act of 1997, the GAO noted. This act makes HCFA responsible for implementing 335 provisions, as well as the Balanced Budget Refinement Act of 1999, which added another 133 provisions. HCFA is thus overwhelmed by the range of new options afforded Medicare beneficiaries, according to the GAO. Recent Medicare reform proposals, such as Breaux-HCFA, must be modernized in order to meet the financing challenges brought about by an aging population and increasingly expensive medical technology, the GAO said, and it concluded that no single proposal offers a complete solution.

Democrats unveil their drug coverage plan

In another ongoing national health care debate, a drug benefit to Medicare recipients took center stage in mid-May as President Bill Clinton and Rep. Richard Gephardt (D-Missouri) unveiled their party's plan for providing drug coverage for the nation's seniors. Under the unified Democratic plan, Medicare beneficiaries would have the option to enroll in a prescription drug plan that would defray 50% of the costs of the prescription drugs up to $5,000, with the details of the plan drawing heavily on the proposals the president announced last year. One key difference in the new plan is a stop-loss provision to cover beneficiaries with unusually high prescription drug costs. "We desperately need a competitive plan to provide a prescription drug benefit that is optional, affordable, accessible to all [and] based on competition, not price controls to boost seniors' bargaining power to get the best possible price; and one that addresses the devastating burden of catastrophic coverage," Clinton said.

Like the president's original proposal, the unified plan would be a sort of "Medicare Part D," managed by private-sector contractors who would negotiate volume discounts, with all beneficiaries receiving at least a 50% premium support. Low-income beneficiaries would receive a higher premium support. The coverage would be phased in over five years.

Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement that the plan "threatens to limit seniors' access to medicines, especially the newer, more innovative – and often most cost-effective – treatments. The Democrats' prescription drug plan offers seniors nothing more than a one-size-fits-all, big-government program run by federal bureaucrats whose concern will be costs, not care."

The House Republican plan, as well as the bipartisan Breaux-Frist plan introduced just prior to the Democrats' plan rollout, calls for premium supports for private insurance products to deliver a prescription drug benefit to seniors. For their part, the pharmaceutical and biotech sectors have expressed a preference for private insurance.

Video teleconference on medical errors set

The FDA and the American Society for Healthcare Risk Management (Chicago, Illinois) are sponsoring a video teleconference, from 12:30-1 p.m. EDT on June 21, focusing on the issue of medical errors.

The teleconference is designed to assist health care professionals in identifying, preventing and solving problems in the use of medical products, using a case-study format and discussion by a panel of risk managers. The panelists will describe and analyze incidents of actual medical error and share with the audience what was learned about preventing and managing errors.

Viewers will have the opportunity to question the panelists directly over the air by sending an electronic mail message to tvquestion@cdrh.fda.gov, or by telephoning or faxing the teleconference participants at the numbers supplied during the teleconference.

Transplant registry to ID risk information

The American Society of Transplant Surgeons (ASTS; Arlington, Virginia) said last month that it is creating a National Registry to track the growing number of living donor liver transplants, noting there still is "insufficient information to accurately assign risk" for people considering the possibility of being living donors.

Creation of the registry was announced by ASTS President Nancy Ascher at Transplant 2000, the joint scientific meeting of the American Society of Transplant Surgeons and the American Society of Transplantation in Chicago. "The continued shortage of cadaver livers – combined with a liver transplant waiting list that has now climbed to more than 15,000 – is leading a growing number of patients to consider living donor liver transplants," said Ascher, chairman of the department of surgery at the University of California at San Francisco.

While the early experience with adult-to-adult living donor transplantation at centers performing this complex procedure is encouraging, "Donor deaths have occurred," she said, noting that "Because of the lack of data, accurate risk assessment for the donor currently is not possible. We hope to solve that by establishment of the ASTS Registry."

The ASTS released a "Position Paper on Adult-to-Adult Living Donor Liver Transplantation," setting out specific guidelines for donor and recipient selection, center criteria, and the best approach to obtaining informed consent.