MEDICAL EVIDENCE APPROVED BY THE
COURTS AS AN ALTERNATIVE TO BIOPSY FOR THE PRIMARILY-INFECTED
HEMOPHILIAC WHO IS AN APPROVED HCV INFECTED PERSON
1. This Protocol sets out the alternative medical
evidence approved by the Courts under Section 4.01(5)
of Article Four of the Hemophiliac HCV Plan (the
"Alternative Medical Evidence Protocol").
2. Section 4.01(5) of Article Four of the Hemophiliac
HCV Plan permits a Primarily-Infected Hemophiliac
who is an Approved HCV Infected Person to establish:
| (a) |
Disease Level 3 - Section 4.01
(1)(c)(i); |
| (b) |
Disease Level 4 - Section 4.01(2); |
| (c) |
Disease Level 5 - Section 4.01(1)(d)(i)
or 4.01(1)(d)(v); and, |
| (d) |
Disease Level 6 - Section 4.01(1)(e)(ii)
or 4.01(i)(e)(v);
without the necessity of a biopsy. |
3. This Alternative Medical Evidence Protocol
shall only be available to a Primarily-Infected
Hemophiliac who is an Approved HCV Infected Person
where the Treating Physician certifies to the Administrator:
| a) |
that he or she is unable to assign
the disease level he or she considers most appropriate
for his or her patient due to the absence of
a biopsy; and |
| b) |
that the Primarily-Infected Hemophiliac
does not have any of the other medical conditions
applicable at the disease level for which qualification
is sought. |
4. To utilize this Alternative Medical Evidence
Protocol in respect of the following disease levels
of the Hemophiliac HCV Plan, the Primarily-Infected
Hemophiliac who is an Approved HCV Infected Person
must deliver the following for consideration by
the Administrator:
| (a) |
FOR DISEASE LEVEL 3
SECTION 4.01(1)(c)(i) |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a liver biopsy,
the opinion of a gastroenterologist, hepatologist,
internist or hemophiliac treating physician
based on non-invasive testing and diagnosis,
complete details of which are provided, that
if the Primarily-Infected Hemophiliac were to
undergo a liver biopsy, such biopsy would more
likely than not demonstrate that he or she has
developed fibrous tissue in the portal areas
of the liver with fibrous bands extending out
from the portal area but without any bridging
to other portal tracts or to central veins (i.e.,
non-bridging fibrous);
|
| (b) |
FOR DISEASE LEVEL 4 -
SECTION 4.01(2) |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a liver biopsy,
the opinion of a gastroenterologist, hepatologist
internist or hemophiliac treating physician
based on non-invasive testing and diagnosis,
complete details of which are provided, that
if the Primarily-Infected Hemophiliac were to
undergo a liver biopsy, such biopsy would more
likely than not demonstrate that he or she has
developed fibrous tissue in the portal areas
of the liver with fibrous bands bridging to
other portal areas or to central veins but without
nodular formation or nodular regeneration (i.e.,
bridging fibrous); |
| (c) |
FOR DISEASE LEVEL 5 -
SECTION 4.01(1)(d)(i) |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a liver biopsy,
the opinion of a gastroenterologist, hepatologist,
internist or hemophiliac treating physician
based on non-invasive testing and diagnosis,
complete details of which are provided, that
if the Primarily-Infected Hemophiliac were to
undergo a liver biopsy, such biopsy would more
likely than not demonstrate that he or she has
developed fibrous bands in the liver extending
or bridging from portal area to portal area
with the development of nodules and regeneration
(i.e. cirrhosis); |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a kidney biopsy,
the opinion of a gastroenterologist, hepatologist,
internist, nephrologist or hemophiliac treating
physician based on non-invasive testing and
diagnosis, complete details of which are provided,
that if the Primarily-Infected Hemophiliac were
to undergo a kidney biopsy, such biopsy would
more likely than not demonstrate that he or
she has developed glomerulonephritis not requiring
dialysis which is consistent with infection
with HCV; |
| (d) |
FOR DISEASE LEVEL 6 -
SECTION 4.01(1)(e)(ii) |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a liver biopsy,
the opinion of a gastroenterologist, hepatologist,
internist or hemophiliac treating physician
based on non-invasive testing and diagnosis,
complete details of which are provided that
if the Primarily-Infected Hemophiliac were to
undergo a liver biopsy, such biopsy would more
likely than not demonstrate that he/she has
developed hepatocellular cancer; |
| |
i) |
a satisfactorily completed HEMO2
Treating Physician Form; and, |
| |
ii) |
in the absence of a kidney biopsy,
the opinion of a gastroenterologist, hepatologist,
internist, nephrologist or hemophiliac treating
physician based on non-invasive testing and
diagnosis, complete details of which are provided,
that if the Primarily-Infected Hemophiliac were
to undergo a kidney biopsy, such biopsy would
more likely than not demonstrate that he or
she has developed glomerulonephritis requiring
dialysis which is consistent with infection
with HCV. |
5. The Administrator may, if the Administrator
deems it appropriate, obtain further medical opinions
or require an independent medical examination in
respect of the disease level of the Primarily-Infected
Hemophiliac who is an Approved HCV Infected Person
seeking to qualify under this Alternative Medical
Evidence Protocol.
6. This Alternative Medical Evidence Protocol will
be periodically reviewed to determine if there is
any change to the medical evidence which is generally
accepted by the medical profession and amendments
may be sought in the future in order that it keep
pace with evolving medical science.
|
