2023 Archdiocese of Atlanta Meritain Group Plan Doc - Manual / Resource - Page 79
(1)
If the drug or device cannot be lawfully marketed without approval of the U.S. Food and Drug Administration
(FDA) and approval for marketing has not been given at the time the drug or device is furnished, then it is
deemed to be Experimental and/or Investigational; or
(2)
If the drug, device, medical treatment or procedure or the patient informed consent document utilized with the
drug, device, treatment or procedure, was reviewed and approved by the treating facility's Institutional Review
Board or other body serving a similar function or if federal law requires such review or approval, then it is
deemed to be Experimental and/or Investigational; or
(3)
If Reliable Evidence shows that the drug, device, medical treatment or procedure is the subject of on- going
Phase I or Phase II clinical trials or is the subject of the research, Experimental, study, Investigational or other
arm of on-going Phase III clinical trials or is otherwise under study to determine its maximum tolerated dose,
its toxicity, its safety, its efficacy or its efficacy as compared with a standard means of treatment or diagnosis,
then it is deemed to be Experimental and/or Investigational; or
(4)
If Reliable Evidence shows that the prevailing opinion among experts regarding the drug, device, medical
treatment or procedure is that further studies or clinical trials are necessary to determine its maximum
tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with a standard means of treatment
or diagnosis, then it is deemed to be Experimental and/or Investigational.
Reliable Evidence shall mean only published reports and articles in the authoritative medical and scientific literature;
the written protocol or protocols used by the treating facility or the protocol(s) of another facility studying
substantially the same drug, service, medical treatment or procedure; or the written informed consent used by the
treating facility or by another facility studying substantially the same drug, device, medical treatment or procedure.
Drugs are considered Experimental if they are not commercially available for purchase and/or they are not approved
by the FDA for general use.
Expenses for drugs, devices, services, medical treatments or procedures related to an Experimental and/or
Investigational treatment (related services) and complications from an Experimental and/or Investigational
treatment and their related services are excluded from coverage, even if such complications and related services
would be covered in the absence of the Experimental and/or Investigational treatment.
Final determination of Experimental and/or Investigational, Medical Necessity and/or whether a proposed drug,
device, medical treatment or procedure is covered under the Medical Plan will be made by and in the sole discretion
of the Employer.
This definition will not apply to any treatment the Covered Person is receiving that is the only treatment available
and/or is considered standard of care and does not violate church doctrine.
Extended Care Facility: An institution or that part of any institution which operates to provide convalescent or
nursing care which: (1) is primarily engaged in providing to inpatients skilled nursing care and related services for
patients who require medical or nursing care; or rehabilitation services for the rehabilitation of injured, disabled, or
sick persons; (2) has policies which are developed with the advice of (and with provision for review of such policies
from time to time by) a group of professional personnel, including one or more Physicians and one or more
registered nurses (R.N.) to govern the skilled nursing care and related medical or other services it provides; (3) has
a Physician, a registered nurse (R.N.), or a medical staff responsible for the execution of such policies; (4) has a
requirement that the health care of every patient be under the supervision of a Physician, and provides for having
a Physician available to furnish necessary medical care in case of emergency; (5) maintains clinical records on all
patients; (6) provides twenty-four (24) hour nursing service which is sufficient to meet nursing needs in accordance
with the policies developed above, and has at least one registered nurse (R.N.) employed full time; (7) provides
appropriate methods and procedures for the dispensing and administering of drugs and injections; (8) in the case
of an institution in any state in which state or applicable local law provides for the licensing of institutions of this
nature, is licensed pursuant to such law, or is approved by the agency of the state or locality responsible for licensing
institutions of this nature as meeting the standards established for such licensing; and (9) meets any other
conditions relating to the health and safety of individuals who are furnished services in such institutions or relating
to the physical facilities thereof.
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