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Nanomedicine -- Financial, Legal, Operational, Political, Clinical, and Ethical Challenges to Implementation

William Sullivan1 and Thomas Sullivan*, 2

1Eastern Maine Medical Center (Leave of Absence)
2Phillips Exeter Academy
Veazie, Maine 04401 USA

This is an abstract for a presentation given at the
11th Foresight Conference on Molecular Nanotechnology

 

Nanotechnology is a new and disruptive technology with respect to the current medical establishment. The introduction of nanomedical techniques, devices, procedures, protocols, therapeutic modalities, and instruments into the medical community will be accompanied by financial, legal, operational, political, clinical, and ethical (FLOPCE) challenges to successful and timely implementation.

Financial and Legal Considerations: Once the Food and Drug Administration has designated the proposed nanomedical innovation as safe and effective, the Centers for Medicare and Medicaid Services may actively and centrally (national coverage determination) or passively (local carrier determination) decide whether the nanomedical innovation is indeed reasonable and necessary and thus worthy of coverage and hence reimbursement under Medicare regulations. Such acceptance by Medicare is often a precursor to reimbursement under Medicaid. Of course, actual reimbursement for interventions will be predicated upon the inauguration of new CPT (Current Procedural Terminology) codes, a separate numeric identifier for each specific type of nanomedical intervention.

Operational Considerations: Acceptance or rejection of new technologies into medical communities varies by region. In many instances, the nanomedical innovation will require physicians and other professionals to obtain training, perhaps certification, and, in the case of some licensed independent professionals, local hospital privileges. Laboratory and radiologic support professionals may have similar requirements in order to support the front-line clinical personnel.

Political Considerations: Physicians are very specialized knowledge workers who sometimes exhibit territorial tendencies toward their particular procedural "turf." So called "turf wars" over specialty boundaries can and do arise between and among various specialties, both at the national, specialty society level as well as at the level of the local hospital. Some physicians may reject the innovation out of hand because it competes with their practice pattern, which they may feel to be therapeutically safer or superior.

Clinical Considerations: Who are the ideal candidates for the nanomedical innovative intervention? Which patients should be excluded? Who will teach and proctor the first surgeon in the institution to introduce the new technique? Are the nurses trained to render the necessary post-operative care in an competent manner? Accordingly, the introduction of the nanomedical intervention may involve national, regional, and/or local clinical trials (and hence an Institutional Review Board), the mobilization of a cadre of "visiting professors" to demonstrate and thus disseminate the innovation, and a rollout of in-service training sessions for the nursing staff.

Ethical Considerations: The launch of new technology into the medical corpus has always been fraught with opportunities for ethical lapses and intentional transgressions involving any and all of the above considerations. Nanomedical innovations will be no exceptions to this historical rule of thumb.

Take-Home Message: Even the most technologically sophisticated nanomedical innovation is liable to delay or even flunk its passage into actual medical practice without thoughtful advanced FLOPCE planning and judicious execution of its implementation process.


*Corresponding Address:
Thomas Sullivan
Preventive and Occupational Medicine Section
Phillips Exeter Academy
36 Silver Ridge
Veazie, Maine 04401 USA
Phone: 410-786-9313 Fax: 410-786-6857
Email: BusinessGP@aol.com



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