Is ‘new’ reason enough to deny payment for an experimental procedure?
Is new’ reason enough to deny payment for an experimental procedure?
MA case breaks ground on medical necessity, coverage
In a move that many hope will lead to better access to organ transplants for people infected with HIV, a Massachusetts board of appeals has reversed a state payer’s denial of coverage for a liver transplant operation for an HIV-positive man.
An appeals board with the Massachusetts Division of Medical Assistance reversed an earlier decision by one of its contracted health plans that denied coverage of a liver transplant consultation on the grounds that the man’s HIV status made any such procedure experimental. Procedures considered experimental do not meet the payer’s medical necessity guidelines.
"Our client was HIV-positive, but he is asymptomatic and his infection poses no threat to his life," says Bennett Klein, an attorney with Gay and Lesbian Advocates and Defenders, a Boston-based advocacy group that represented the patient. "But he is coinfected with hepatitis C and has end-stage liver disease."
The payer’s contention that the transplant would be experimental was based solely on the patient’s HIV status and not any other clinical criteria, he adds. "But we were able to submit scientific evidence that although this is a new procedure, just being new isn’t enough to make it experimental."
Until recent years, patients infected with HIV were considered ineligible for transplants because it was thought that immunosuppressive drugs given to prevent rejection of the donor organ would decimate the patient’s immune system and lead to more rapid progression to full-blown AIDS. And prior to advancements made in HIV therapy in the mid-1990s, patients were thought to have too short a life expectancy to benefit from the surgery.
However, advances in both HIV treatments and immunosuppressive therapy have prompted some transplant surgeons, medical ethicists, and AIDS activists to challenge the conventional wisdom that these patients should not be candidates for transplant.
"The past arguments for automatically excluding [someone] from liver transplantation are no longer applicable; they are obsolete," says Klein.
In fact, the Richmond, VA-based United Network for Organ Sharing (UNOS) has never considered HIV infection to be a contraindication to transplant eligibility, and has policies stating HIV-positive people should be included on transplant lists.
Currently, however, only two transplant centers, the University of Pittsburgh Medical Center (UPMC) and the University of Miami (FL), are performing solid organ transplants in HIV-infected patients. Approximately 12 to 20 more centers are considering performing heart, liver, and kidney transplants in HIV patients, but only as part of a controlled, three-year, multicenter research study based at the University of California San Francisco (UCSF).
Most insurers and transplant centers still consider transplanting organs into HIV-positive patients too risky, especially given the severe shortage of available donor organs.
Long-term studies needed
Despite the advances in medical treatment, patients with HIV still face unique complications from undergoing organ transplant surgery, and these procedures need clinical study before being widely performed, some medical experts claim.
"It seems to me that the argument goes that given that HIV is now in many ways a chronic disease with life expectancies in patients of 10 years or more, it makes sense to offer those patients transplants," says Robert Arnold, MD, professor of medicine in the division of general internal medicine. Arnold also is chief of the section of palliative care and medical ethics at the UPMC Health System.
Arnold also provides primary care for HIV-positive inpatients at the medical center. "I think we should have some idea of what the success and failures are so that patients and doctors understand, and society understands, what the true risks and benefits are."
The surgeons at UPMC are confident that they have the clinical knowledge and expertise to perform transplants in some HIV-positive patients, Arnold says. Transplant teams led by UPMC surgeon John Fung, MD, have performed four liver transplants and two kidney transplants on HIV-positive patients since 1995. And UPMC surgeons are collecting clinical data on all of the procedures they perform.
It may be that only performing these transplants at a limited number of centers until more data are collected will yield better results in the long run, than all transplant centers agreeing to do them now, Arnold adds.
For example, appropriately managing immunosuppressive therapy in conjunction with anti-retroviral regimens is a complication for HIV-positive patients not shared by other transplant patients. Instead of a large number of centers experimenting on different patients, a few centers might be able to more quickly ascertain the best practices.
"It is probably a good idea, rather than everyone doing it without clear data, to have it done in a controlled manner," he says.
Some have no time to wait
While it’s true that good, hard data on the safety and efficacy of solid organ transplants in HIV patients do not yet exist, it’s difficult to argue that HIV patients should not have access to transplants until large-scale studies have been performed, says Michelle Roland, MD, assistant clinical professor at UCSF. Roland also is an HIV specialist at San Francisco General Hospital. UCSF has received funding from the National Institutes of Health and private sources for its proposed three-year, multicenter study of organ transplants for this patient group.
Physicians often say that performance of experimental medical procedures should be initially restricted to clinical trials at selected centers until more data are collected. The argument being that, until safety data are first collected, it is impossible to know whether the procedure is actually helping patients, harming patients, or having no real benefit.
"I don’t think that’s a valid argument in this situation, particularly when you are talking about someone with end-stage liver disease [ESRD]," Roland says. "For patients in liver failure, the only alternative to a transplant is death."
There is no hard evidence that transplants in HIV patients are not safe and effective either, she points out.
As a medical researcher, Roland would like to be able to collect clinical data for her study from every transplant procedure performed on patients with HIV. Such information would allow providers to develop best practice guidelines that much sooner.
However, it’s unrealistic to expect that Roland’s study will receive the kind of funding necessary to include every center that would like to participate.
"There will be patients who need a transplant, who, for financial or geographic reasons, cannot go to a center that is part of a study," she says. "I cannot argue that these patients should not have access."
As for the coverage issue, Roland agrees with the argument that these transplant operations are experimental, but disagrees that payers should use that as criteria for denying coverage for what is essentially a patient’s last hope.
"We need the insurers to cover the clinical costs of performing these operations in order to be able to determine the safety and efficacy," she says.
Decision may affect others’ plight
The decision by the Massachusetts board may make other payers less likely to automatically exclude HIV patients from consideration for transplant, hopes Klein. "While it is not a court decision, we have a very detailed, 23-page ruling that includes all of the scientific evidence we presented."
Though he emphasizes the need to collect clinical data, Arnold also says he hopes the increased attention will lead to HIV-positive patients being considered potential transplant candidates.
"HIV patients should be treated the way all other candidates with chronic diseases are treated," he says. "We need to consider whether the organs would be saving lives and what affect they have on the patients’ lives. They should neither be more likely to get an organ because of the advocacy of HIV-positive groups, nor should decisions be prejudiced because they have HIV."
Sources
- Robert Arnold, MD, Section of Palliative Care and Medical Ethics, University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA 15213-2582.
- Michelle Roland, MD, HIV Specialist, San Francisco General Hospital, Ward 84, Building 80, 995 Potrero Ave., San Francisco, CA 94110.
- Bennett Klein, JD, Gay and Lesbian Advocates and Defenders. Telephone: (617) 426-1350.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.