A fellow social worker inquired whether a patient with CJD (Creutzfeldt Jakob Disease) could be admitted to hospice with that diagnosis. She also asked if the fact that the person is participating in a Phase I clinical trial would preclude them from receiving the medicare hospice benefit.
With regard to the first question, CJD, a rapidly progressing form of dementia which proceeds to death within a relatively short period as opposed to Alzheimer's type dementias. Individuals suffering from CJD, if otherwise eligible for Medicare, can usually receive the hospice benefit because of the rapidly progressing nature of their terminal illness.
With regard to the second question, historically patients who are participating in clinical trials have not been eligible for the Medicare hospice benefit because patients on clinical trials were viewed as still pursuing curative care which was viewed as antithetical to hospice and violated the Medicare requirement that in order to obtain the hospice benefit the patient has to forego curative care for his/her terminal illness.
A study by Casarett DJ, Karlawish JH, Henry MI, and Hirschman KB of the Center for Health Equity Research and Promotion at the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA. email@example.com, titled, Must patients with advanced cancer choose between a Phase I trial and hospice?, which was published in Cancer. 2002 Oct 1;95(7):1601-4, found that, "Most hospices and Phase I principal investigators believe that eligible patients should be allowed to enroll simultaneously in hospice and Phase I trials. These results suggest that the choice between hospice and a Phase I trial is a false dilemma and that greater collaboration in this area is needed."
In 2003, Ira Byock, MD and Steven H. Miles, MD published an article in the Annals of Internal Medicine Vol. 138 No. 4 February 18, 2003, pp 335-337, titled, Hospice Benefits and Phase I Cancer Trials. In summary, he argued that, "Medicare denies hospice coverage to patients with terminal illnesses who enroll as participants in Phase I studies, which assess the toxicity and dosing of potential treatments for incurable diseases. Federal regulations require patients to forgo curative therapies, and they interpret phase I agents as treatment for the terminal condition for which hospice care was elected. Thus, by enrolling as a participant in a phase I trial, a patient otherwise eligible for hospice is rendered ineligible. Private insurers have similar provisions for children and adults younger than 65 years of age. Such exclusions are not defensible on ethical or clinical grounds. Policymakers, insurers, and institutional review boards all have a role in resolving this problem."
Later that year, Byock also published an article in Supportive Oncology, Vol 1, #2, July-August, 2003, titled, Palliative Care and the Ethics of Research: Medicare, Hospice, and Phase I Trials. In that article he argued that there is no clinical or ethical justification for failing to allow hospice patients to enroll in clinical trials and for persons in clinical trials to be denied entry into hospice.
Most hospice programs will not accept people on clinical trials. Some are willing to consider accepting patients on clinical trials on an individual basis. However, even if the local hospices are not willing to accept the person because he or she is on a on a clinical trial, a person on a clinical trial should be able to obtain concurrent palliative care to manage their pain and other symptoms and to aid them and their family/caregivers in coping with the terminal illness. A number of studies have validated the benefit, both to the patient and to the research being conducted, of providing palliative care concurrent with a clinical trial.
This being said, it is important to note that some hospices and palliative care services conduct clinical trials relating to treatment for the alleviation and management of pain and other symptoms. These clinical trials are not for the purpose of developing or providing curative treatments for a terminal illness and, therefore, do not create problems with regard to Medicare funded hospice placement.
I would suggest that the social worker check with the local hospices and with the hospice association in her state to see if a hospice will consider accepting this patient. I would also suggest that she attempt to locate a palliative care program (maybe affiliated with a hospice) which will provide palliative care without hospice admission. (i.e., palliative care in a nursing home or palliative care together with home care). The social worker may also wish to consider contacting the CJD Foundation's help line at 800-659-1991 (M-F 9-5). Their website is at http://www.cjdfoundation.org/, to explore other options and to identify resources for the patient and the patient's family.