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BC AMD Expansion Program - Effective April 1 2011

 

PROVINCIAL HEALTH SERVICES AUTHORITY (“PHSA”)
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT
EXPANSION PROGRAM EFFECTIVE APRIL 1, 2011
Background:
Wet age-related macular degeneration (“Wet AMD”) is a serious disease that can
strike quickly
and is a leading cause of blindness among seniors. Prior to June 1, 2009, the only
pharmaceutical treatment for Wet AMD for which the Province of British Columbia
Ministry of
Health Services (“MoHS”) provided reimbursement was verteporfin (currently sold
under the
trade-mark “Visudyne”) with photodynamic therapy; the reimbursement was provided
through a
program administered by PHSA. As of June 1, 2009, through the reimbursement
program
established by the MoHS, the MoHS began to provide reimbursement for Wet AMD
pharmaceutical treatment with verteporfin, ranibizumab (currently sold under the
trade-mark
“Lucentis”) and bevacizumab (currently sold under the trade-mark “Avastin”) on certain
terms
and conditions. The British Columbia Wet Age-Related Macular Degeneration
Treatment
Expansion Program (the “AMD Expansion Program”) described in this document
replaces the
British Columbia Wet Age-Related Macular Degeneration Treatment Program which
was
effective for the fiscal year commencing on April 1, 2010 and expires on March 31,
2011 (the
“Fiscal 2010 AMD Expansion Program”). As set out below, the 2011 AMD Program is
effective April 1, 2011 and will continue until March 31, 2012 unless amended or
terminated
earlier as provided for in this Program Document.
The Fiscal 2010 AMD Expansion Program, and its predecessor program that
commenced June
1, 2009, was developed by the MoHS in consultation with the representatives of the
retinal
specialist group in British Columbia and was restricted to that specialist group to
optimize drug
utilization appropriateness and cost control, to minimize drug wastage, and to
facilitate data
collection, monitoring, measuring and reporting.
PHSA’s mandate is to ensure the planning, coordination, accessibility, quality,
efficiency and
effectiveness of selected province-wide health care programs and services, including
the
development and management of expectations and funding allocations for selected
health care
programs and services in the Province of British Columbia. The MoHS has engaged
PHSA to
continue to administer the AMD Expansion Program.
This Program Document sets out the terms and conditions applicable to the AMD
Expansion
Program effective April 1, 2011. This Program Document has been separated into two
parts.
Part I contains the terms which apply in all cases to the AMD Expansion Program and
to all
Licensed Ophthalmologists with Retinal Disease Fellowship who wish to make any
claim for
reimbursement under, or participate in any way in, the AMD Expansion Program and
AMD
Expansion Fund. Part II of this Program Document applies only to those Licensed
Ophthalmologists with Retinal Disease Fellowship who are Program Registrants and
who agree

in the specified form to perform, and do perform, certain additional obligations to
assist in
achieving the full objectives of the AMD Expansion Program and which MoHS believes
will
provide additional benefits to Wet AMD patients in British Columbia and facilitate the
operation
of the AMD Expansion Program within available fiscal resources.
PART I
TERMS OF THE AMD EXPANSION PROGRAM APPLICABLE TO ALL LICENSED
OPHTHALMOLOGISTS WITH RETINAL DISEASE FELLOWSHIPS
Part I of this Program Document applies to all Licensed Ophthalmologists with Retinal
Disease
Fellowships who wish to make any claim for reimbursement under, or participate in
any way in
the AMD Expansion Program and AMD Expansion Fund.
1. DEFINITIONS:
In addition to the defined terms set out elsewhere in this Program Document, this
Program
Document (both Part I and Part II) the following terms will have the following
meanings:
(a) Administrative Fee has the meaning given to it in Section 23;
(b) AMD Database means the database established pursuant to Section 9;
(c) AMD Database Consent has the meaning given to it in Section 10;
(d) AMD Database Guidelines means those criteria, purposes and guidelines for the
AMD
Database as set out in Appendix A, as may be amended by PHSA from time-to-time;
(e) AMD Expansion Fund has the meaning given to it in Section 2;
(f) AMD Expansion Program has the meaning given to it above;
(g) AMD Treatment Guidelines means the treatment guidelines developed and
established
by the group representing the Licensed Ophthalmologists with Retinal Disease
Fellowships dated May and November, 2009 and provided to the MoHS and PHSA;
(h) Angiography means fluorescein angiography;
(i) Bevacizumab has the meaning given to it in Section 3(b);
(j) Committee has the meaning given to it in Section 22;
(k) Effective Date means April 1, 2011;
(l) Eligible Drug Costs has the meaning given to it in Section 11;
(m) Eligible Patient means a patient who:
(i) is a resident of British Columbia enrolled as a beneficiary in the Medical Services
Plan;

(ii) has been diagnosed with Wet AMD; and
(iii) meets the criteria for treatment as set out in the AMD Treatment Guidelines;
(n) Fiscal Year means a 12 month period commencing on April 1 of any year and
ending on
March 31 of the following year;
(o) Health Authority means a regional health board designated under Section 4(1) of
the
Health Authorities Act (British Columbia);
(p) Licensed Ophthalmologist with Retinal Disease Fellowship means a physician who
has been licensed as an ophthalmologist by the College of Physicians and Surgeons
for
the Province of British Columbia AND has successfully completed a Retinal Disease
Fellowship of at least 1 year duration. Where PHSA determines it is appropriate, PHSA
may consult with the Retinal Specialist Group to determine whether the training of a
physician meets the foregoing requirements;
(q) MoHS means the Ministry of Health Services for the Province of British Columbia;
(r) OCT means optical coherence tomography;
(s) Part I of the AMD Expansion Program has the meaning given to it in Section 7;
(t) Part II of the AMD Expansion Program has the meaning given to it in Section 8;
(u) Program Registrant means a Licensed Ophthalmologist with Retinal Disease
Fellowship that delivers the signed Acknowledgement to PHSA in the form set out in
Appendix D.
(v) PHSA means the Provincial Health Services Authority;
(w) Program Document means this document as modified from time-to-time by PHSA
(subject to any required review and approval by the MoHS) and all Appendices to this
program document;
(x) Ranibizumab has the meaning given to it in Section 3(a);
(y) Retinal Specialist Group means all Licensed Ophthalmologists with Retinal Disease
Fellowships practicing in the Province of British Columbia who are Program
Registrants,
as represented by Dr. Derek Godinho on behalf of the Association of BC Retinal
Specialists;
(z) Verteporfin/PDT has the meaning given to it in Section 3(c); and
(aa) Wet AMD means the Wet form of Age-Related Macular Degeneration.

2. AMD EXPANSION FUND:
The MoHS has made available to PHSA for the operation of the AMD Expansion
Program a
maximum of $13.0 Million for the period from the Effective Date to March 31, 2012. For
subsequent Fiscal Years, funding for any continuation of the AMD Expansion Program
will be in
such amounts as may be made available to PHSA from MoHS specifically for the
applicable
Fiscal Year of the AMD Expansion Program. Any funds made available by the MoHS to
PHSA
for the AMD Expansion Program in the applicable Fiscal Year will be referred to in this
Program
Document as the “AMD Expansion Fund”.
The AMD Expansion Fund, and thus the continued operation of the AMD Expansion
Program
and any subsequent or replacement programs, is at all times subject to the MoHS
having
provided funds to PHSA for such purposes for the Fiscal Year in which such funds are
required.
In addition to its rights generally to modify or terminate the AMD Expansion Program
and/or the
Program Document, the PHSA reserves the right to make any changes to the AMD
Expansion
Program or to terminate the AMD Expansion Program entirely if the MoHS, or
equivalent
funding bodies, increases or decreases the funding allocation to PHSA for the AMD
Expansion
Program or the amount of the AMD Expansion Fund for a Fiscal Year has been
exhausted.
3. PRESCRIPTION DRUG THERAPIES COVERED BY THIS PROGRAM:
(a) Ranibizumab (currently sold under the trade-mark “Lucentis”);
(b) Bevacizumab (currently sold under the trade-mark “Avastin”); and
(c) Verteporfin for Injection (currently sold under the trade-mark “Visudyne”) with
photodynamic therapy (“Verteporfin/PDT”).
4. PROGRAM GOALS:
The goals of the AMD Expansion Program, as established by the MoHS, are to:
(a) provide publicly-funded reasonable access to treatment for Wet AMD to Eligible
Patients
in each Health Authority, as provided below;
(b) provide mechanisms to ensure that the costs of the AMD Expansion Program do
not
exceed the amount of the AMD Expansion Fund; and
(c) establish and maintain a database of information on each of the drug therapies
reimbursed under the AMD Expansion Program for the purposes of research, planning
and management of the AMD Expansion Program and for such other purposes as
described in the AMD Database Consent.
5. TERM AND TERMINATION OF AMD EXPANSION PROGRAM:
The AMD Expansion Program will be in effect from the Effective Date until March 31,
2012
unless revised or extended by MoHS and PHSA. The AMD Expansion Program may be
terminated at any time by PHSA or at the direction of MoHS. Where reasonably
practicable,
PHSA or MoHS will consult with the Health Authorities and the Retinal Specialist Group
prior to

any planned early termination of the AMD Expansion Program. Subject to the direction
of
MoHS and consistent with the annual budget cycle for each Fiscal Year, PHSA intends
to
consult with the Retinal Specialist Group and the regional Health Authorities regarding
the
possibility of the continuation of the AMD Expansion Program beyond March 31, 2012
and will
communicate to the MoHS the financial and other requirements reasonably necessary
to do so.
6. AMD TREATMENT GUIDELINES:
After review and discussion among the members of the Association of BC Retinal
Specialists,
the members or representatives of the Association of BC Retinal Specialists
independently
developed, recommended and adopted the AMD Treatment Guidelines to assist
Licensed
Ophthalmologists with Retinal Disease Fellowships in making treatment decisions with
respect
to their patients. Representatives of the Association of BC Retinal Specialists
informed MoHS
that the AMD Treatment Guidelines are consistent with the terms, objectives, and
funding
available under the AMD Expansion Program. In addition, to assist MoHS in
determining the
amount of the AMD Expansion Fund, representatives of the Association of BC Retinal
Specialists informed the MoHS that, based on the past experience of the members of
the
Association of BC Retinal Specialists, including the actual drug utilization average for
the Fiscal
Year 2009 and Fiscal Year 2010 in British Columbia, they have advised MoHS and
PHSA of the
anticipated number of treatments of Eligible Patients in the Fiscal Year 2011 and
pharmaceutical drug therapy utilization.
7. PARTICIPATION IN PART I OF THE AMD EXPANSION PROGRAM:
Provided that they comply with the terms set out in Part I of this Program Document,
each
Licensed Ophthalmologist with Retinal Disease Fellowship is eligible to participate in
the portion
of the AMD Expansion Program described in Part I of this Program Document (referred
to as
“Part I of the AMD Expansion Program”), including reimbursement of Eligible Drug
Costs.
Upon submission to PHSA of a claim by any Licensed Ophthalmologist with Retinal
Disease
Fellowship for reimbursement of Eligible Drug Costs, such Licensed Ophthalmologist
with
Retinal Disease Fellowship automatically agrees to comply with the terms applicable
to Part I of
the AMD Expansion Program set out in this Program Document.
8. OPTION TO REGISTER TO PERFORM THE ADDITIONAL ACTIVITIES UNDER PART
II OF THE AMD EXPANSION PROGRAM:
Registration as a Program Registrant
If a Licensed Ophthalmologist with Retinal Disease Fellowship is willing to commit to
perform
the additional activities with respect to, and comply with the terms of, that part of
the AMD
Expansion Program set out in Part II of this Program Document (referred to as “Part II
of the
AMD Expansion Program”), in addition to Part I of the AMD Expansion Program, the
Licensed
Ophthalmologist with Retinal Disease Fellowship must sign and deliver to PHSA an
Acknowledgement in the form set out in Appendix D to evidence such agreement. By
signing
and delivering such Acknowledgement to PHSA, such Licensed Ophthalmologist with
Retinal
Disease Fellowship agrees to comply with all aspects of the AMD Expansion Program
described
in Part I and Part II of this Program Document.

PHSA will provide a copy of this Program Document to each Licensed Ophthalmologist
with
Retinal Disease Fellowship in British Columbia. For each Licensed Ophthalmologist
with
Retinal Disease Fellowship in British Columbia as of the Effective Date, such
Acknowledgement
must be signed and delivered to PHSA if that Licensed Ophthalmologist with Retinal
Disease
Fellowship wishes to participate in Part II of the AMD Expansion Program. For any new
Licensed Ophthalmologist with Retinal Disease Fellowship that becomes qualified as
such after
the Effective Date, such Licensed Ophthalmologist with Retinal Disease Fellowship
must elect
within 10 days of submission of their first claim for reimbursement of Eligible Drug
Cost whether
they also wish to participate in Part II of the AMD Expansion Program by signing and
delivering
to PHSA the Acknowledgment referred to above. PHSA will have the right to extend
the time
periods set out in this Section 8 in which the signed Acknowledgement must be
provided.
Withdrawal or Removal as a Program Registrant
In the event that a Program Registrant wishes to withdraw from the AMD Expansion
Program,
he or she will notify PHSA in writing of their decision to withdraw and the effective
date of their
withdrawal. In addition, in the event that PHSA or the MoHS determines that any
Program
Registrant is not complying with their respective obligations under the AMD Expansion
Program
or this Program Document, PHSA and MoHS may remove such Program Registrant from
Part II
of the AMD Expansion Program on 15 days’ written notice to such Program Registrant,
unless
such non-compliance can be remedied and is remedied by such Program Registrant to
PHSA
and MoHS’ satisfaction during such notice period.
In order to provide and encourage continuity to Part II of the AMD Expansion Program
and
efforts in connection therewith, once a Licensed Ophthalmologist with Retinal Disease
Fellowship:
(a) elects to not register as a Program Registrant in the Fiscal Year in which they are
first
eligible to do so; and
(b) if he or she had registered as a Program Registrant, subsequently elects to
withdraw as
a Program Registrant; or
(c) is removed as a Program Registrant for non-compliance with the terms of the AMD
Expansion Program or this Program Document;
PHSA or MoHS may, in their sole discretion, refuse to permit such Licensed
Ophthalmologist
with Retinal Disease Fellowship to register or re-register as a Program Registrant,
whether in
the same Fiscal Year or in any subsequent Fiscal Year. A Licensed Ophthalmologist
with
Retinal Disease Fellowship who elects not to register as a Program Registrant or has
withdrawn
or been removed as a Program Registrant will continue to be eligible to participate in
Part I of
the AMD Expansion Program (but not Part II of the AMD Expansion Program) provided
that they
are complying, and continue to comply, with the terms set out in Part I of this
Program
Document.

9. AMD PATIENT DATABASE:
PHSA has established a computer database (the “AMD Database”) to assist with
monitoring,
evaluation, planning and management of the AMD Expansion Program, the treatments
covered
under the AMD Expansion Program and for such other purposes as the MoHS or PHSA
may
specify from time to time. A description of the AMD Database is set out in the AMD
Database
Guidelines. In order to be eligible to receive any Eligible Drug Costs and/or
Administrative Fees
under the AMD Expansion Program, the Licensed Ophthalmologist with Retinal Disease
Fellowship submitting a claim for payment of such amounts must first have entered
into the
AMD Database the patient information and treatment data set out in the AMD
Database
Guidelines for such patient and treatment, in addition to complying with the other
requirements
set out in Section 10. PHSA may limit the information required to be submitted in the
AMD
Database by Licensed Ophthalmologist with Retinal Disease Fellowship who is
claiming
reimbursement of Eligible Drug Cost under Part I of the AMD Expansion Program but is
not a
Program Registrant. By submitting a claim for payment of Eligible Drug Costs under
the AMD
Expansion Program, each Licensed Ophthalmologist with Retinal Disease Fellowship is
also
agreeing to enter into the AMD Database any patient follow-up data available to that
physician
as set out in the AMD Database Guidelines.
10. INFORMED CONSENT TO TREATMENT AND TO INCLUSION OF PATIENT
INFORMATION IN THE AMD DATABASE:
Each Licensed Ophthalmologist with Retinal Disease Fellowship will be responsible to
obtain
the informed consent of their respective patient to all treatment provided to that
patient by that
physician in such form as that physician believes is appropriate under the
circumstances and in
compliance with all applicable laws.
In addition to such informed consent to treatment, each Licensed Ophthalmologist
with Retinal
Disease Fellowship will also obtain the consent of each patient whose information is
entered
into the AMD Database to the collection, use and disclosure of that patient’s personal
health
information for any of the purposes set out in the AMD Database Guidelines, as may
be revised
from time to time by PHSA. The form of such informed consent is set out in Appendix
C, as may
be revised by PHSA from time-to-time (the “AMD Database Consent”). If the patient is
unwilling to sign the AMD Database Consent, the Licensed Ophthalmologist with
Retinal
Disease Fellowship will be required to note that patient’s objection in the applicable
AMD
Database field as described more fully in the AMD Database Guidelines. PHSA has the
right to
request that each Licensed Ophthalmologist with Retinal Disease Fellowship provide
to PHSA
copies of all AMD Database Consents obtained by such physician.
11. REIMBURSEMENT OF DRUG COST:
Subject to adjustment as set out in Sections 15 to 17 inclusive, and provided the
other criteria
for reimbursement as set out in this Program Document are met, PHSA will reimburse
a
Licensed Ophthalmologist with Retinal Disease Fellowship for the actual verifiable
out-of-pocket
cost incurred by them to purchase the pharmaceuticals reimbursed under the AMD
Expansion
Program (Avastin, Lucentis and Verteporfin/PDT) for their Eligible Patients, except
that,

notwithstanding the actual drug cost, the amount to be reimbursed under the AMD
Expansion
Program for such pharmaceuticals will not exceed the following:
(a) For one individual syringe of Avastin: $13.13;
(b) For one individual syringe of Lucentis: $598.33; and
(c) For one treatment of Verteporfin/PDT: $1,770;
(referred to as the “Eligible Drug Costs”). The above amounts to be reimbursed
applies to a
single treatment (dosing) of an Eligible Patient. As a condition of claiming
reimbursement of
Eligible Drug Costs and participating in Part I of the AMD Expansion Program, each
Licensed
Ophthalmologist with Retinal Disease Fellowship will be responsible for drug supply
management for their Eligible Patients and for reporting and reconciliation of drug
costs as
required under this Program Document.
For clarity, in the event that a Licensed Ophthalmologist with Retinal Disease
Fellowship is not a
Program Registrant, that Licensed Ophthalmologist with Retinal Disease Fellowship
remains
eligible to be reimbursed for Eligible Drug Cost under this Section 11 but will not be
eligible to
payment of any Administrative Fees as of the date that they are no longer
participating in the
AMD Expansion Program. Administration Fees paid prior to a Program Registrant
withdrawing
or being removed as a Program Registrant in any Fiscal Year are subject to the terms
of this
Program Document, including Section 13.
Nothing in this Program Document limits the right of PHSA or MoHS to reimburse out
of the
AMD Expansion Fund any Eligible Drug Costs incurred in connection with the treatment
outside
of British Columbia of an Eligible Patient, whether such reimbursement is made
directly to the
Eligible Patient or their out-of-province medical care provider.
12. SUBMISSION OF A CLAIM FOR REIMBURSEMENT OF ELIGIBLE DRUG COSTS:
In order to obtain any reimbursement for Eligible Drug Costs under the AMD Expansion
Program the Licensed Ophthalmologist with Retinal Disease Fellowship must have
complied
with the following in respect of each claim for reimbursement for the treatment of a
particular
patient:
(a) the Licensed Ophthalmologist with Retinal Disease Fellowship must first determine
and
be satisfied that the patient meets the criteria under the AMD Treatment Guidelines
for
the type of treatment to be provided;
(b) the Licensed Ophthalmologist with Retinal Disease Fellowship must enter into the
AMD
Database all eligibility and reimbursement information in the format and containing
the
information required by PHSA from time to time for which fields are included in the
AMD
Database;
(c) the Licensed Ophthalmologist with Retinal Disease Fellowship must confirm by
entering
into the applicable field in the AMD Database that the Licensed Ophthalmologist with
Retinal Disease Fellowship has sought the AMD Database Consent from such patient

and that either (i) the Licensed Ophthalmologist with Retinal Disease Fellowship has
obtained the AMD Database Consent signed by such patient, or (ii) such patient has
refused to give the AMD Database Consent;
(d) the patient must have received treatment by that Licensed Ophthalmologist with
Retinal
Disease Fellowship in accordance with the AMD Treatment Guidelines; and
(e) the Licensed Ophthalmologist with Retinal Disease Fellowship must provide to
PHSA
each quarter copies of pharmacy and or supplier invoices verifying the actual out of
pocket drug cost expense incurred to substantiate and reconcile with Eligible Drug
Costs
reimbursed in that quarter.
It is expected that all claims for reimbursement of Eligible Drug Cost under the AMD
Expansion
Program be submitted within 5 business days after bi-monthly period during which the
treatment
giving rise to such reimbursement claim was performed. Although it is the expectation
that all
claims be submitted promptly within the foregoing time-frame, in all cases the
maximum
allowable time to submit a claim for reimbursement under the AMD Expansion Program
is 90
days after the date on which the treatment giving rise to such reimbursement claim
was
performed. PHSA may, in its sole discretion, allow extensions of such time period on a
case-by-
case basis for individual claims but any such extension granted will not apply to any
future
claims.
If all criteria for reimbursement have been fulfilled or satisfied and entered into the
AMD
Database as required, PHSA will endeavour to remit payment for such amount properly
claimed
to the claimant within an average of 10 business days although PHSA will not
guarantee
payment within that time period. In addition, in order for PHSA to be able to process
payments,
each Licensed Ophthalmologist with Retinal Disease Fellowship submitting such claim
for
reimbursement must provide (or have previously provided) to PHSA a direct deposit
form and
any other payment processing information required by PHSA in such format as may be
required
by PHSA, including authorization to permit electronic funds transfer of payments to
such
physician’s account.
PHSA may, in its discretion, refuse any claim for reimbursement under the AMD
Expansion
Program of either Eligible Drug Cost under this Part I or Administrative Fees under Part
II where
PHSA believes that the criteria for reimbursement as set out in this Program Document
have not
been fulfilled or satisfied.
The Eligible Drug Cost includes all drug, supplies, pharmacy processing fees,
procedure costs
and costs to perform the activities required in connection with the treatment but
excludes the
physician and technical fees for performing the procedure (including the cost of the
Licensed
Ophthalmologist with Retinal Disease Fellowship performing the intravitreal injection
of such
drug), OCT interpretation, Angiography interpretation and corresponding office visit
fees that are
reimbursed through the fee-for-service billing arrangements under the British Columbia
Medical
Services Plan. Except for such reimbursement as is specifically provided for under this
Program Document, the Licensed Ophthalmologists with Retinal Disease Fellowships
will
continue to be responsible for the provision and cost of all staffing, supplies,
equipment and
overhead and other costs associated with the care and treatment of their Eligible
Patients.

Whether or not the Licensed Ophthalmologist with Retinal Disease Fellowship elects
to
become a Program Registrant or receives Administrative Fees under Part II of the AMD
Expansion Program, no Licensed Ophthalmologist with Retinal Disease Fellowship may
charge or accept payment from an Eligible Patient for Avastin, Lucentis or
Verteporfin/PDT or any fees in respect of that patient’s treatment, nor may they cause
any other individual to charge or accept payment from an Eligible Patient for Avastin,
Lucentis or Verteporfin/PDT or any fees in respect of that Eligible Patient’s treatment
for
Wet AMD. For clarity, an Eligible Patient may not be charged any additional fees in
respect of any aspect of that Eligible Patient’s treatment for Wet AMD.
 
13. REPAYMENT OF AMOUNTS IN EXCESS OF THE ELIGIBLE DRUG COSTS AND
OVERPAYMENT OF ADMINISTRATIVE FEES:
In the event that a Licensed Ophthalmologist with Retinal Disease Fellowship:
(a) who is not a Program Registrant has received amounts from PHSA for the
treatment of
Eligible Patients in respect of periods from or after the Effective Date which are in
excess of any
Eligible Drug Costs to which such Licensed Ophthalmologist with Retinal Disease
Fellowship
would be eligible for reimbursement under the AMD Expansion Program; or
(b) a Program Registrant who has received or receives any time after the Effective
Date
Eligible Drug Costs or Administrative Fees in respect of any period in excess of those
which that
Program Registrant may be entitled to under this Program Document, including as a
result of a
payment in excess of the Administrative Fees to which he or she may be entitled in
any
Quarterly Reimbursement Period or Fiscal Year, or other adjustments described in Part
II of this
Document;
then PHSA or MoHS may require that such excess amount be repaid by the Licensed
Ophthalmologist with Retinal Disease Fellowship to PHSA within 30 days of a written
request to
do so by PHSA or MoHS. In the event that such Licensed Ophthalmologist with Retinal
Disease
Fellowship or Program Registrant fails to repay such excess amounts within such time
period, in
addition to any other rights and remedies available to them at law to recover such
amounts,
PHSA and/or MoHS will have the right to deduct such excess amounts from any future
amounts
(including Eligible Drug Costs and/or Administrative Fees) that would otherwise be
payable to
the Licensed Ophthalmologist with Retinal Disease Fellowship or Program Registrant
under the
AMD Expansion Program in the then current Fiscal Year or any future Fiscal Year in
which the
AMD Expansion Program (or successor program) may be continued. The rights of PHSA
and
MoHS under this Section 13 survive the termination or expiry of the AMD Expansion
Program.
14. RIGHT TO REQUEST INFORMATION TO VERIFY ACCURACY OF
REIMBURSEMENT CLAIMS:
PHSA and/or the MoHS has the right to request access to further information from, or
audit the
applicable records of, any Licensed Ophthalmologist with Retinal Disease Fellowship
to confirm
the accuracy of the information provided to PHSA or entered into the AMD Database in
connection with any request for reimbursement under the AMD Expansion Program,
including

the right to request copies of all invoices/receipts to support and/or audit any claim
for
reimbursement of Eligible Drug Costs.
15. ONGOING REVIEW OF AMD EXPANSION PROGRAM TO PREVENT COST
OVERRUNS:
In order to ensure that the costs of the AMD Expansion Program are maintained within
the
amount of the AMD Expansion Fund, on a regular basis, at such times as PHSA
considers
appropriate, PHSA will provide or make available to the Committee (directly or through
the AMD
Database) non-identifiable information on the volume of treatments paid by PHSA
under the
AMD Expansion Program in that Fiscal Year. Where trends indicate the possibility that
the total
annual volume of treatments eligible to be reimbursed under the AMD Expansion
Program are
reasonably expected to exceed the foregoing number and would otherwise result in a
cost
overrun for the AMD Expansion Program, PHSA will consult with the Retinal Specialist
Group to
consider and evaluate corrective measures to ensure that the cost of the AMD
Expansion
Program does not exceed the available amount of the AMD Expansion Fund for that
year. The
foregoing will not limit or delay PHSA’s right under Sections 15 to 17, inclusive, to at
any time,
with or without such consultation or before such consultation is concluded, make any
changes
to the AMD Expansion Program and this Program Document.
16. ADJUSTMENTS TO FUNDING UNDER THE AMD EXPANSION PROGRAM:
At any time PHSA may, subject to any required review and approval by the MoHS,
adjust the
amounts to be paid under the AMD Expansion Program in order to:
(a) ensure that the costs of the AMD Expansion Program do not exceed the amount of
the
AMD Expansion Fund or to otherwise adjust the amounts, including as a result of the
review undertaken pursuant to Section 15; or
(b) take into account any new or additional efficacy, utilization, safety, cost-
effectiveness,
usage information, treatment regimes or other data concerning any of the drugs then
being reimbursed under the AMD Expansion Program and/or any new alternate
therapies or regimens for the treatment of Wet AMD.
17. MODIFICATIONS TO THE AMD EXPANSION PROGRAM:
Subject to any required review and approval by the MoHS, PHSA reserves the right at
any time
to modify, terminate and interpret all or any aspect of the AMD Expansion Program,
the AMD
Expansion Fund and the terms of this Program Document. Where reasonably
practicable, prior
to initiating any significant modification to the AMD Expansion Program of other than
an
administrative nature, PHSA intends to consult with the Health Authorities and Retinal
Specialist
Group to solicit their input on the proposed modification.
18. PROGRAM DOCUMENT IS NOT MEDICAL ADVICE:
Nothing in this Program Document is intended to be or should be considered to be a
substitute
for or constitute medical advice. All medical decisions are solely the responsibility of
the
prescribing physician and patient.

 
PART II
ADDITIONAL ACTIVITIES TO BE PROVIDED BY, AND COMPENSATION TO, THOSE
LICENSED OPHTHALMOLOGISTS WITH RETINAL DISEASE FELLOWSHIP WHO ARE
ALSO PROGRAM REGISTRANTS
Part II of this Program Document applies only to those Licensed Ophthalmologists
with Retinal
Disease Fellowships who are Program Registrants. Notwithstanding the foregoing,
PHSA may,
on request from a Program Registrant from time-to-time, permit a Program Registrant
to utilize
one or more locum physicians who are Licensed Ophthalmologists with Retinal Disease
Fellowships (a “locum”) to perform treatments on behalf of a Program Registrant
provided that
the Program Registrant remains responsible to ensure that such locum complies with
the terms
of this Program Document in respect of all Eligible Patients treated by such locum,
including the
requirement to enter all data in respect of Eligible Patients treated by such locum into
the AMD
Database and to ensure that an AMD Database Consent has been obtained by all
Eligible
Patients. In addition, as set out in Section 25, since the responsibility to provide
regional access
to care under Section 19 and other activities under Section 20 remains with the
Program
Registrant (and not the locum), any Administrative Fees that may be claimed by the
locum
under Part II of the AMD Expansion Program will be deducted from the maximum
Administrative
Fees that such Program Registrant would otherwise have been eligible to receive.
No person other than a Program Registrant (and their respective locum physicians
meeting the
above criteria) is required to perform the duties under Part II of this Program
Document, nor are
they eligible to receive any Administrative Fees or other benefits under Part II of this
Program
Document.
As a condition of being and remaining a Program Registrant and receiving
Administrative Fees
under Part II of the AMD Expansion Program, each Program Registrant must:
(a) obtain and maintain at all times privileges from the health authority having
jurisdiction in
the region in which that Program Registrant treats an Eligible Patient; and
(b) comply with all terms and conditions attached to privileges granted to the Program
Registrant, as such terms and conditions are specified by the health authority granting
such privileges.
19. REGIONAL ACCESS TO CARE FOR WET AMD PATIENTS:
As a condition of receiving Administrative Fees under this Part II of the AMD
Expansion
Program, the Retinal Specialist Group and each Program Registrant individually
commits to the
MoHS and to PHSA to ensure that the Program Registrants will make themselves
available on a
reasonable and timely basis to provide regional consultation, treatment and follow-up
care to
Eligible Patients from those sites within each Health Authority where the required
diagnostic and
other equipment, including Angiography and OCT equipment, is or becomes available.
Attached as Appendix B is a list of the centres at which the Program Registrants will
attend and
provide such care. Such regional visiting centres are provided in [.Kelowna, Cranbrook
and

Nelson] with [the clinic at Terrace in process and] other sites under review. The
Retinal
Specialist Group will also provide to the MoHS and PHSA a detailed schedule that sets
out the
rotation schedule to be met by all Program Registrants to meet their commitment to
provide
reasonable and timely consultation, treatment and follow-up care from those centres.
Each
Program Registrant will carry equal responsibility for staffing the rotation schedule as
a
condition of receiving Administrative Fees under Part II of the AMD Expansion
Program.
The establishment and continuation of the AMD Expansion Program is contingent on
the Retinal
Specialist Group meeting its obligations under this Section 19, Appendix B and that
rotation
schedule. The Retinal Specialist Group will make the rotation schedule available to
each Health
Authority and, on a regular basis or at the request of PHSA or a Health Authority, will
be
available to consult with and advise the Health Authority in the applicable region,
MoHS or
PHSA on any issues arising with respect to access to or timeliness of care for Eligible
Patients
within that region. If any patient access deficiencies are identified by PHSA, a Health
Authority
or the MoHS, the Retinal Specialist Group will develop a strategy and revise the
rotation
schedule to address the deficiencies.
20. ADDITIONAL ACTIVITIES TO BE PERFORMED BY PROGRAM REGISTRANTS TO
SUPPORT THE AMD EXPANSION PROGRAM:
 
In addition to the specific requirements set out in this Program Document, each
Program
Registrant will be expected to:
 
(a) In collaboration with the Retinal Specialist Group, develop and update the AMD
Treatment Guidelines to support optimal patient care and keeping the MoHS and PHSA
informed on a regular basis (through Committee meetings or such other method as
requested by PHSA or MoHS) of current scientific literature, new clinical trials and
clinical trial results, conference papers or abstracts and other significant new
information
or data regarding advances in the prevention, diagnosis and treatment of Wet AMD or
any of the pharmaceuticals reimbursed under the AMD Expansion Program;
 
(b) Assist the MoHS and PHSA as requested to continue to develop and support the
AMD
Database with the objective to monitor the safety and effectiveness of the different
treatments for Wet AMD reimbursed under the AMD Expansion Program (Avastin,
Lucentis and Verteporfin/PDT);
 
(c) In collaboration with the MoHS and PHSA, assist the MoHS and PHSA to monitor
the
budget and costs of the AMD Expansion Program and to advise on different
management strategies needed to ensure that the costs of the AMD Expansion
Program
do not exceed the amount of the AMD Expansion Fund while still meeting the care
needs of all Eligible Patients;
 
(d) Meet their respective commitments to provide regional access to care as set out in
Section 19 and Appendix B;
 
(e) Participate in any AMD Expansion Program quality assurance to ensure compliance
with
and maintenance of standards of care within the AMD Expansion Program and review
of
the performance within the AMD Expansion Program of each Licensed Ophthalmologist

with Retinal Disease Fellowship, and to assist with research activities requested by
PHSA or the MoHS;
 
(f) Participate in the review and reporting of adverse events and outcomes
experienced
using any of Avastin, Lucentis or Verteporfin/PDT; and
 
(g) Participate in the Joint Accountability Committee as described under Section 21.
21. FAILURE OF RETINAL SPECIALIST GROUP TO MEET ITS OBLIGATIONS TO
PROVIDE REASONABLE ACCESS TO CARE:
In the event that PHSA determines that the Retinal Specialist Group is unable or
unwilling to
meet its obligations under this Program Document, including Sections 18 and 19, then
PHSA
will notify the Retinal Specialist Group that such obligations are not being satisfied. In
the event
that the Retinal Specialist Group does not, in the opinion of PHSA, propose any
satisfactory
plan to meet its obligations under this Program Document, then, without limiting the
right the
MoHS or PHSA otherwise has to amend or terminate the AMD Expansion Program or
the
Program Document, PHSA may, in its sole discretion but subject to any required review
or
approval by the MoHS, amend or terminate this Program Document and the AMD
Expansion
Program and take such measures as they consider appropriate, including ensuring that
reasonable access to medical care is being provided to Eligible Patients in all regions
of the
Province of British Columbia.
22. PARTICIPATION OF REPRESENTATIVES OF THE PROGRAM REGISTRANTS IN
THE JOINT ACCOUNTABILITY COMMITTEE:
A Joint Accountability Committee (the “Committee”) has been established to provide a
forum
for discussion amongst the MoHS, PHSA and the Retinal Specialist Group. The
mandate of the
Committee is to:
(a) monitor, review and discuss the effectiveness of the AMD Expansion Program;
(b) subject to compliance with all applicable privacy laws, review the data obtained
through
the AMD Database;
(c) review the costs of the AMD Expansion Program and make recommendations to the
MoHS and PHSA as to measures to be taken to ensure that the costs of the AMD
Expansion Program do not exceed the amount of the AMD Expansion Fund;
(d) monitor the performance by the Program Registrants in relation to the AMD
Expansion
Fund and under Section 19;
(e) make recommendations to the MoHS and PHSA with respect to any changes to the
AMD Expansion Program; and
(f) consider such other matters related to the AMD Expansion Program as may be
requested from time-to-time by the MoHS or PHSA.

The Committee will be comprised of an equal number of representatives from each of
PHSA,
the MoHS and the Retinal Specialist Group. PHSA will appoint the Chair of the
Committee and
develop the terms of reference under which the Committee will operate. The
Committee may
make recommendations with respect to the AMD Expansion Program to the MoHS
and/or
PHSA but the Committee will have no power to make decisions with respect to the
AMD
Expansion Program, nor will the MoHS or PHSA be obligated to adopt any of the
recommendations of the Committee.
23. ADMINISTRATION FEES FOR PERFORMANCE OF DUTIES UNDER PART II OF
THE AMD EXPANSION PROGRAM:
 
As used in this Program Document:
 
(a) Administrative Fee means $300 per single treatment (dosing) of an Eligible Patient
with Avastin, Lucentis or Verteporfin/PDT, subject to adjustment under Sections 15 to
17, inclusive, and Section 24;
 
(b) Administrative Fee Global Available Amount in a Fiscal Year is the amount
determined by PHSA which equals the difference between the AMD Expansion Fund
for that Fiscal Year and the total amount of all Eligible Drug Costs paid or payable
under the AMD Expansion Program (irrespective of to whom the Eligible Drug Costs
were paid) in respect of the same Fiscal Year;
 
(c) Annual Individual Administrative Fee Available Amount or Annual IAFAA means
the maximum amount of all Administrative Fees payable to each single Program
Registrant, which is determined by dividing the Administrative Fee Global Available
Amount by the number of Program Registrants participating in the AMD Expansion
Program in that Fiscal Year (prorated for any Program Registrant participating for only
a partial Fiscal Year), as adjusted pursuant to Sections 24 to 25, inclusive, except
that
in no event will the Annual Individual Administrative Fee Available Amount or Annual
IAFAA exceed for each individual Program Registrant an amount which is equal to
1,200 treatments multiplied by the amount of the Administrative Fee;
 
(d) Quarterly Individual Administrative Fee Available Amount or Quarterly IAFAA
means the amount determined by dividing the Annual IAFAA for the same Fiscal Year
by four (4), as adjusted pursuant to Sections 24 to 25, inclusive, except that in no
event will the Quarterly Individual Administrative Fee Available Amount or Quarterly
IAFAA exceed for each individual Program Registrant an amount which is equal to 300
treatments multiplied by the amount of the Administrative Fee;
 

(e) Quarterly Reimbursement Period means each of the following periods in any Fiscal
Year:
 
(i) April 1 to June 24;
(ii) June 25 to September 16;
(iii) September 17 to December 9; and
(iv) December 10 to March 31;
 
as may be adjusted by PHSA from time-to-time.
 
In recognition of the activities that they are required to perform under Part II of the
AMD
Expansion Program, and subject to adjustment as set out in this Program Document,
provided
the other criteria for reimbursement as set out in this Program Document are met,
Program
Registrants will be eligible to receive payment of an Administrative Fee for each single
treatment (dosing) of an Eligible Patient with Avastin, Lucentis or Verteporfin/PDT up
to a
maximum amount in any Quarterly Reimbursement Period and Fiscal Year equal to the
Quarterly IAFAA for that Quarterly Reimbursement Period and the Annual IAFAA for
that Fiscal
Year, respectively. The Quarterly IAFAA and Annual IAFAA limit the number of
treatments for
which any one Program Registrant may receive Administrative Fees to 300 treatments
in any
Quarterly Reimbursement Period and 1,200 in any Fiscal Year or such lesser amount as
determined as provided within the definition of the Quarterly IAFAA and Annual IAFAA
or as
determined and adjusted by PHSA pursuant to Sections 24 to 25, inclusive.
 
Once an individual Program Registrant has received the Quarterly IAFAA in respect of
the
corresponding Quarterly Reimbursement Period or the Annual IAFAA in respect of the
corresponding Fiscal Year, the Program Registrant will not be entitled to receive any
further
Administrative Fees in respect of that same Quarterly Reimbursement Period or Fiscal
Year,
respectively, irrespective of the number of treatments that the Program Registrant
provides in
that Quarterly Reimbursement Period or Fiscal Year, respectively, that would
otherwise have
been eligible for an Administrative Fee had such thresholds not been met. Any
overpayment of
Administrative Fees in any Quarterly Reimbursement Period or Fiscal Year will be
repaid to
PHSA by the Program Recipient or deducted from future amounts payable to that
Program
Recipient as provided for in Section 13.
24. ADMINISTRATIVE FEES – BUDGETS, RECONCILIATION, ADJUSTMENTS AND
REPAYMENT:
 
PHSA will determine (based on the amount of the AMD Expansion Fund in any Fiscal
Year, the
number of treatments of Avastin, Lucentis and Verteporfin/PDT and associated Eligible
Drug
Costs that PHSA projects to occur in a Fiscal Year for Eligible Patients and such other
factors
as PHSA considers relevant) an estimated amount for the Administrative Fee Global
Available
Amount for that Fiscal Year, and based on that amount and the projected number of
Program
Registrants anticipated for that Fiscal Year, the estimated Quarterly IAFAA and Annual
IAFAA
for that Fiscal Year. Such estimates will be used by PHSA for the purpose of
determining
eligibility of payment of Administrative Fees unless and until adjusted by PHSA in
accordance
with Section 25.

 
Within 30 days of the end of each Quarterly Reimbursement Period or at such other
times as
may be specified by PHSA, the Committee will meet to review the costs of the AMD
Expansion
Program in the prior Quarterly Reimbursement Periods in that Fiscal Year and consider
projected costs of the AMD Expansion Program for the remainder of the Fiscal Year.
The
Committee will consider all relevant information and make a recommendation to PHSA
on any
adjustments needed to the amount of the Administrative Fee, Quarterly IAFAA and/or
Annual
IAFAA or any other aspect of the AMD Expansion Program in order to ensure that the
costs of
the AMD Expansion Program (including both Eligible Drug Costs and Administrative
Fees) in
that Fiscal Year do not exceed the amount of the AMD Expansion Fund. PHSA will
consider
such recommendations and, in addition to its right under Sections 15 to 17, will have
the
discretion to determine what adjustments, if any, are needed to any of the
Administrative Fee,
Quarterly IAFAA, Annual IAFAA or other aspects of the AMD Expansion Program and
will
advise the Program Registrants of any such adjustment. Adjustments may be
prospective or
retrospective, or both, and any prior overpayment resulting from a retrospective
adjustment will
be repaid to PHSA by the applicable Program Recipient or deducted from future
amounts
payable to that Program Recipient as provided for in Section 13.
 
Where an adjustment is required to the Administrative Fee, Quarterly IAFAA or Annual
IAFAA in
order to ensure that the costs of the AMD Expansion Program in any Fiscal Year do not
exceed
the amount of the AMD Expansion Fund, PHSA will advise the Program Recipients
through the
Committee. If the Program Recipients unanimously agree that such adjustment should
be
allocated among them other than as otherwise provided in this Program Document,
the Program
Recipients may by notice in writing to PHSA signed by the Program Recipients request
such
alternate allocation method be used and, provided neither PHSA or MoHS has
objections to
such alternate allocation method, such method will then be applied to any such
adjustments or
overpayment recoveries in respect of that fiscal year. If the Program Recipients fail to
repay
any Administrative Fees owing utilizing such alternate allocation method, PHSA
retains all rights
it otherwise would have had under this Program Document in order to ensure that the
cost of
the AMD Expansion Program does not exceed the AMD Expansion Fund.
25. ADMINISTRATIVE FEES – MONTHLY REPORTING, PRORATION, CARRY-
FORWARD AND ADJUSTMENT FOR ADMINISTRATIVE FEES PAID TO LOCUMS:
 
The following additional terms apply to the calculation and payments of
Administrative Fees:
(a) Monthly Usage Summaries – PHSA will provide to the Program Registrants a
monthly
summary showing the amount of Eligible Drug Costs and Administrative Fees claimed
by
such Program Registrant under the AMD Expansion Program in the prior month and the
number of treatments of Eligible Patients with each of Avastin, Lucentis and
Verteporfin/PDT in that prior month.
(b) Proration for Partial Quarters/Years - In the event a Program Registrant is not a
Program Registrant for an entire Quarterly Reimbursement Period and Fiscal Year, the
Quarterly IAFAA and Annual IAFAA for that Program Registrant will be prorated

according to the proportion of time in such Quarterly Reimbursement Period and Fiscal
Year in which he or she was a Program Registrant.
(c) Individual Quarterly Carry-Forward - It is recognized that treatment volumes may
vary
throughout the course of a Fiscal Year; therefore, in the event that a particular
Program
Registrant does not invoice for the maximum amount of the Quarterly IAFAA in respect
of any Quarterly Reimbursement Period, then the balance remaining between the
amount actually paid or payable to that Program Registrant in respect of that
Quarterly
Reimbursement Period and the maximum Quarterly IAFAA for that Quarterly
Reimbursement Period may be carried forward in respect of that Program Registrant
and added to the Quarterly IAFAA amounts that such Program Registrant is eligible to
receive during the remainder of that same Fiscal Year. No such amounts may be
carried
forward between Fiscal Years nor may they be applied to the Quarterly IAFAA (or
Annual
IAFAA) for other Program Registrants.
(d) Locums - PHSA and/or MoHS may deduct from the Annual IAFAA and Quarterly
IAFAA
to which the Program Registrant may otherwise have been entitled equal to any
Administrative Fees claimed under the Program by locums engaged or utilized by that
Program Registrant to treat that Program Registrant’s Eligible Patients or in fulfilling
that
Program Registrant’s obligations under the rotation schedule set out in Appendix B to
the
AMD Expansion Program Document. For the purposes of the foregoing, PHSA will have
the sole discretion to determine whether a physician is acting as a locum for a
particular
Program Registrant and to determine the manner in which the amount of the Program
Registrant’s Annual IAFAA and Quarterly IAFAA are adjusted as a result of any
Administrative Fees claimed by a locum.
26. ADMINISTRATIVE FEES – INVOICING AND PAYMENT:
The terms and conditions applicable to the submission of claims or invoices for, and
payment of
Eligible Drug Costs, as set out in Part I of this Program Document will also apply to
the
submission of claims or invoices for, and payment of, Administrative Fees.
 

PROVINCIAL HEALTH SERVICES AUTHORITY
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT
EXPANSION PROGRAM
 
APPENDIX A
AMD DATABASE GUIDELINES
 
See attached.
 

 
 
 
 
 
 
 
 
 
 
Guide to the AMD Tracking Worksheet
 
British Columbia Wet Age-Related Macular Degeneration
Treatment Program Expansion (AMD Expansion Program)
 
 
 
Version 1.2
 
Date: May 28, 2009
 
 
 
 
This is a guide to support Retinal Specialist offices in accurately and comprehensively
tracking key information as participants in the AMD Expansion Program.
 

1. BACKGROUND
As participants of the AMD Expansion Program there will be on-going tracking of initial
consult,
treatment and follow up activities related to the treatment of wet AMD. The PHSA and
the
Ministry of Health will use this information for monitoring, evaluating, planning and
management
of the program.
 
The AMD Expansion Program started on June 1, 2009 and has been continued for the
fiscal
year commencing April 1, 2011 on the terms set out in the Program Document for the
2011
AMD Expansion Program. Due to the time frame, there will be two approaches to
tracking
volumes for the purposes of reimbursement:
 Initial tracking system which will focus on collecting the data via spreadsheets with
secure file transfer (effective June 1, 2009)
Long-term AMD tracking system which will involve the implementation of either a new
database application at each Retinal Specialist office or the expansion of existing
systems to capture the data required for the AMD Expansion Program. The design of
this system will be based on the findings from a needs analysis that is currently being
performed.

 
For the purposes of this document we will focus on the initial tracking system.
 
2. ACTIVITY TO BE TRACKED
Relevant activity involved in the treatment of patients in the AMD Expansion Program
(i.e.,
patients with a diagnosis of AMD with choroidal neovascularization) should be tracked
including:
 Initial consultation (no injection)
New initial injection (injection #1, visit includes consultation),
Subsequent injection (on-going treatment, visit includes consultation),
Recurrent injection (visit includes consultation, injections restarted after a period of
stabilization)
Follow-up visit (assessment only, no injection)
Follow-up visit (termination of injections)

 
Each of the above activities should be reported on a separate line (row) in the
worksheet.
 
 
Please note that as part of this AMD Expansion Program we are requiring the tracking
of some
data elements that your office may currently not collect. For those offices with
electronic health
records it is anticipated that some of the required information may be extracted from
your
systems.
 
Other offices may choose to use a separate form on a per-patient basis. The optional
AMD
Patient Chart Form is intended to standardize and simplify the information collection
process.
The information still needs to be entered into the AMD Utilization Tracking Worksheet
before
being submitted to the PHSA. The use of the per-patient form is completely optional.
A copy of
the form is in Appendix A
 

Note: In the event that a patient does not give consent for the release of information
to
the PHSA, no activity can be reported in the “Health Characteristics” section.
 

Note: In the event that a patient does not give consent for the release of information
to
the PHSA, the only fields that can be reported in the “Injection Information” section
are
the “Drug Type”, and the “Date of Injection”.
 
 
 

 
5. WHAT TO DO WHEN YOU HAVE COMPLETED AN AMD UTILIZATION TRACKING
WORKSHEET
When you have completed an AMD Utilization Tracking Worksheet please remember to
save
it electronically in a file folder.
 
Please remember when handling multiple AMD clinic days, that each AMD clinic day
should be
saved as a separate file. Please be careful to not overwrite previously completed files.
As
described at the beginning of this document is strongly suggested that you make a
copy of the
original Utilization Tracking Worksheet, and save it with a filename of the Retinal
Specialist and
the date of the clinic (i.e. Godinho-Jun-08-2009.xls” to indicate Dr Godinho’s AMD
clinic on
Jun 8th ). This file naming convention should avoid unintended loss of information.
 
6. HOW TO SUBMIT YOUR AMD UTILIZATION TRACKING WORKSHEETS
 
Note: We are currently in the process of setting up the submission process. Additional
details will be made available as the process is put in place.
 
The expected method of transferring the AMD Utilization Tracking Worksheets is by
Secure FTP. A specific type of FTP software must be installed and set up at each
Retinal
Specialist’s office. Draft technical guidelines are provided in Appendix A, but they are
subject to change.
 
A group from the PHSA will support each Retinal Specialist’s office in setting up the
Secure FTP software. This will occur in the first month of the AMD Expansion Program.
 
In the interim, while this is being set up, please save your completed
AMD Utilization Tracking Worksheets (electronic soft copy) in a safe
place.
 
 
 
7. SUPPORT
If you have any questions on this worksheet please contact Derek Stone at 604-707-
5900
x4870 or dstone@phsa.ca.
 
If you have questions that are technical in nature, please contact Randy Savoie at
604-739-
7363 or rsavoie@analysisworks.net
 
 
 

8. APPENDIX A – TECHNICAL GUIDELINES FOR UPLOADING FILES
(Source: PHSA IM/IT)
 
1: To make your first connection:
 
The first time you use CuteFTP, you will see this window. Click Cancel. Then follow the
next
few steps to setup your access to the PHSA server.
 
 
 
 
a. File > New > FTPS (SSL) Site…
 
 
 
 
b. Enter the info below

 

9. APPENDIX B – AMD PATIENT CHART FORM
Retinal Specialists offices may choose to use this form on a per-patient basis to
ensure that the required
activity is collected on each AMD Expansion Program visit.
 
 

AMD Patient Chart Form
Physician Identifier
MSP #:
 
 
 
Patient Information
PHN:
Date of birth:
(mmm dd, yyyy)
Gender:
 M F
Postal code:
(E.g.,V6H3Y8 )
Clinic Location:
 Abbotsford Kamloops New Westminister Surrey Victoria
 Burnaby Kelowna North Vancouver Terrace Other
 Cranbrook Nanaimo Prince George Vancouver
 
 
Payment Information
Responsible for payment:
 BC PHSA FNIHB CDN resident self-pay
 Other Province/Territory DVA/VAC Other country self-pay
 WCB/WSIB Other Federal Government
 
 
 
 
Health Characteristics
Indication:
 AMD with CN Other________________________
Visual acuity (only for eye treated):
_________/_________
Required for all injections. Can also use LP for
“light perception”, HM for “hand movement” and CF
for “count fingers”.
Eye:
 OD OS
Visit Type:
 Initial consultation (no injection)
 New initial injection (injection #1, visit includes consultation)
 Subsequent injection (on-going treatment, visit includes consultation)
 Recurrent injection (visit includes consultation, injections restarted after a period of
stabilization)
 Follow-up visit (assessment only, no injection)
 Follow-up visit (Termination of injections)
 
 
Injection
Drug type:
 Lucentis
 Avastin
 Visudyne
Pharmacy/supplier
id:
 
Method of preparation:
 Single dose syringe
 Vial
Date of injection:
(mmm dd, yyyy)
 
 
Injection informed consent
date: (mmm dd, yyyy)
 
Lot number of the
drug
PHSA info release
informed consent date:
(mmm dd, yyyy)
 
 
PHSA info release
consent:
 Y N
Pharmacy/supplier id:
 E65 - MacDonald's Pharmacy N49 - Novartis VGH - VGH Pharmacy
 
 

 W42 - McKesson Specialty Prescription Q51 - Bonsor Pharmacy M10 - Reid's Pharmacy
 PGRH - Prince George Regional Hospital VIHA - RJH Pharmacy PP388 - Cranbrook's
People's Pharmacy
 H24 - Royal Inland Hospital FSJ - Fort St. John Other
 S28 - North Mont Pharmacy
 
 
CDC Adverse Reaction Reporting
Date of sympton onset: (mmm dd, yyyy)
 
 
Date of related injection/treatment: (mmm dd, yyyy)
Adverse reactions
 No reaction Sterile Endophthalmitis Other__________________________
 Inflammation Floaters __________________________
TASS Blurred Vision
 
 
 
 

PROVINCIAL HEALTH SERVICES AUTHORITY
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT
EXPANSION PROGRAM
 
APPENDIX B
CENTRES FOR WET AMD CARE TO BE SERVICED IN EACH HEALTH AUTHORITY
 
NOTE: THIS NEEDS TO BE UPDATED. EG KELOWNA AND CRANBROOK NEEDS TO BE
REMOVED IF THEY ARE NO LONGER VISITING CENTRES, NEW IHA VISITING CENTRES
ADDED (IF APPLICABLE) AND NEW PROGRAM REGISTRANTS ADDED
 
HA
City
Retinal Specialist
FHA
Abbotsford
Dr. Dhar Dhanda
 
 
Dr. Simon Lam
 
 
Dr. Hugh Parsons
 
 
Dr. Leah Wittenberg
 
Burnaby
Dr. Kelvin Finlay
 
New Westminster
Dr. Dhar Dhanda
 
 
Dr. Simon Lam
 
 
Dr. Hugh Parsons
 
 
Dr. Leah Wittenberg
 
Surrey
Dr. Dhar Dhanda
 
 
Dr. Simon Lam
 
 
Dr. Hugh Parsons
 
 
Dr. Leah Wittenberg
IHA
Cranbrook
(visiting)
Dr. Lica Chui and all
retinal specialists on a
rotational basis
 
Kamloops
Dr. Peter Hopp
 
Kelowna (visiting)
Dr. Peter Hopp and all
retinal specialists on a
rotational basis
NHA
Prince George
Dr. Andrew Lukaris
 

 
Terrace (visiting)
Dr. Andrew Lukaris /
Dr. Patrick Ma and all
retinal specialists on a
rotational basis
VCHA
North Vancouver
Dr. Derek Godinho
 
 
Dr. Farzin Forooghian
 
Vancouver
Dr. Patrick Ma
 
 
Dr. Alan Maberley
 
 
Dr. David Maberley
 
 
Dr. Michael Potter
 
 
Dr. David Albiani
 
 
Dr. William H. Ross
 
 
Dr. Lica Chui
 
 
Dr. Andrew B. Merkur
VIHA
Victoria
Dr. Stan Shortt
 
 
Dr. Murray Erasmus
 
 
Dr. Andrew Burnett
 
Nanaimo
Dr. Elizabeth J. Hay
 
 
* LOCUMS: DR. JUSTIN FRENCH

PROVINCIAL HEALTH SERVICES AUTHORITY
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT
EXPANSION PROGRAM
 
APPENDIX C
AMD DATABASE CONSENT
 
 
PROVINCIAL AMD PROGRAM
CONSENT FOR COLLECTION, USE AND DISCLOSURE OF INFORMATION
 
As your doctor has advised you, the Ministry of Health Services for the Province of
British
Columbia (the "Ministry of Health") is currently operating a program to be
administered by
the Provincial Health Services Authority ("PHSA") to fund and obtain certain
information
about the safety and effectiveness of different treatments for wet age-related macular
degeneration, otherwise known as "wet AMD". That program is referred to as the
"Provincial AMD Program".
 
This form explains what happens to the information that your doctor collects from you
related to you and to your diagnosis and treatment for wet AMD. This form also asks
you to
agree, or consent, to sending this information to the Ministry of Health, to PHSA and
to the
British Columbia Centre for Disease Control (the “CDC”), which is operated by PHSA.
This
consent applies only to the collection, use and disclosure of certain information
about you and is in addition to any consent to medical treatment that you give your
doctor.
 
Before you sign this form, please read all pages carefully, or have them read to you,
and
talk to your doctor about it. Your doctor can answer your questions and help you
understand what will happen to the information we collect about you.
 
What type of information will you be collecting about me?
 

In the course of your diagnosis and treatment for wet AMD, you doctor will be
collecting
information about you that is needed to obtain full or partial reimbursement for your
medical
care by the Ministry of Health and PHSA as well as health and medical information
about
your vision and your diagnosis and treatment for wet AMD. That information may
include:
 
 your personal health number;
your gender, age and date of birth;
your postal code;
your past and future medical information about your vision and your diagnosis
and treatment for wet AMD, including:
o the results of any diagnostic tests your doctor may request or perform in
the course of their evaluation or treatment of your vision and your wet
AMD;
o the pharmaceutical drugs used to treat your wet AMD; and
o the type of procedures and frequency of treatment that your
doctor provides as part of your medical care related to your wet
AMD or your vision;

 information about any other diseases or medical conditions that you have
experienced in the past or experience in the course of being treated by
your doctor that your doctor may consider relevant to the medical care
your doctor provides to you related to your wet AMD or your vision;
information about any side effects or reactions that you may experience
while undergoing medical care by your doctor; and
any other information that your doctor considers relevant to your medical
care.

 
What happens to the information that my doctor collects about me?
 
The information described above that is collected by your doctor will be entered into
a secure server, which we refer to as the “AMD Computer Database”, operated by
PHSA. Secure servers are computers that keep your information confidential. Only
authorized persons from or under contract to the Ministry of Health, PHSA and the
CDC will have permission to look at your information that is stored in the AMD
Computer Database and those persons will be required to keep that information
confidential.

 
How will my information entered into the AMD Computer Database be used?
 
Your doctor will use the information entered into the AMD Computer Database to
provide you with medical care, to request payment from the Ministry of Health or
PHSA for the medical care your doctor provides to you and for your doctor to study
wet AMD and the safety and effectiveness of different treatments for wet AMD.
 
The Ministry of Health, PHSA and the CDC will collect, use and disclose some or all
of the information collected from you and other patients with wet AMD which is
entered into the AMD Computer Database for the following purposes:
 to process and audit payments to your physician related to your medical
care;
for research, planning and management of the Provincial AMD Program;
to evaluate and/or publish information related to wet AMD;
to evaluate and/or publish information related to the different pharmaceutical
drugs and different procedures used to treat wet AMD, including the
effectiveness, safety, use and outcome of those treatments;
to evaluate and respond to any safety concerns that may arise with respect to
one or more of the available treatments for wet AMD;
to provide your information to other doctors and/or researchers studying or
researching wet AMD or the treatments for wet AMD;
to help develop systems that will enable the Ministry of Health, PHSA and CDC
doctors to deliver better or more economical health care for patients with wet
AMD.

 
The information in any publication that is issued by the Ministry of Health, PHSA, the
CDC
or any doctor or researcher that acquires your information would be in a form that
would not
allow others to identify you or to contact you.
 
What if I choose not to consent to having my information entered into the AMD
Computer Database?
 
Certain information about you is required for your doctor to request payment from the
Ministry of Health and PHSA to reimburse your doctor for the costs of your medical
care,

including your name, personal health number and the type of medical care provided to
you.
You are not required to give your consent to all of the above in order to receive
medical
care. If you have concerns about any of the other information listed above being
entered
into the AMD Computer Database or how the Ministry of Health, PHSA or the CDC may
use
your information, then you should discuss with your doctor those concerns and any
additional limits you would like to place on the collection, use or disclosure of your
information.
 
What is the legal authority under which this information ifs collected and to whom
can I direct any other questions I may have about its collection?
 
The Ministry of Health, PHSA and the CDC are authorized to collect this information
under
sections 26(c), 33.1(1)(b), 33.1(1)(i.1) and 33.2(d) of the British Columbia Freedom of
Information and Protection of Privacy Act. If you have questions about the collection,
use or
disclosure of your information, you may contact:
 
Ms. Cindy Brice
Corporate Director, Information Access and Privacy
Provincial Health Services Authority
Suite 200 - 601 W. Broadway
Vancouver, British Columbia
V5Z 4C2 Canada
Phone: 604-707-5834
 
CONSENT
 
I agree that my information collected from and described above can be stored on the
AMD
Computer Database operated by PHSA.
 
I also agree that my doctor, the Ministry of Health, PHSA and the CDC may collect,
use and
disclose the information collected from me as described in this consent and that the
information collected about me will be part of my medical record.
 
 
 
Printed name of patient Signature Date

 
 
 
 
Printed name of Legally Authorized Signature Date
Substitute Decision Maker (if applicable)
 
 
 
Printed name of person getting consent Signature Date
 
 
 

PROVINCIAL HEALTH SERVICES AUTHORITY
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT
EXPANSION PROGRAM EFFECTIVE APRIL 1, 2011
APPENDIX D
PROGRAM REGISTRANTS
ACKNOWLEDGEMENT OF AMD EXPANSION PROGRAM EFFECTIVE APRIL 1, 2011
TERMS FOR PARTICIPATION AND ELIGIBILITY FOR REIMBURSEMENT
 
To: Provincial Health Services Authority (“PHSA”)
Re: AMD EXPANSION PROGRAM DOCUMENT TO BE EFFECTIVE APRIL 1, 2011 (the
“AMD Expansion Program”)
The undersigned hereby acknowledges that he/she has been provided with a copy of
the Fiscal
2011 AMD Expansion Program Document attached as Exhibit A to this
Acknowledgement, and,
as a condition of seeking reimbursement from PHSA under the AMD Expansion
Program, the
undersigned acknowledges and confirms that:
(a) the undersigned is a physician who has been licensed as an ophthalmologist by
the
College of Physicians and Surgeons for the Province of British Columbia AND
successfully
completed a Retinal Disease Fellowship of at least 1 year duration;
(b) eligibility for reimbursement of any amounts, including Eligible Drug Costs and
Administrative Fees, under the AMD Expansion Program is subject to compliance with
all terms
and conditions for eligibility and reimbursement set out in the AMD Expansion Program
Document, as may be amended from time to time;
(c) the undersigned wishes to be a “Program Registrant” and participate in both Part I
of the
AMD Expansion Program and Part II of the AMD Expansion Program, as described in,
and on
and subject to the terms and conditions set out in, the Program Document;
(d) the undersigned acknowledges that, as a further condition of participating as a
“Program
Registrant” in Part II of the AMD Expansion Program, the undersigned must:
(i) obtain and maintain at all times privileges from the health authority having
jurisdiction in the region in which the undersigned treats an Eligible Patient; and
(ii) comply with all terms and conditions attached to such privileges, as specified by
the health authority granting such privileges;
(e) the undersigned acknowledges that PHSA and/or MoHS may deduct from the
Annual
IAFAA and, as applicable, Quarterly IAFAA to which the undersigned may otherwise be
entitled
under Part II of the AMD Expansion Program any Administrative Fees claimed under
the
Program by locums engaged or utilized by the undersigned to assist the undersigned
in treating

his or her Eligible Patients or in fulfilling his or her obligations under the rotation
schedule set
out in Appendix B to the AMD Expansion Program Document;
(f) the undersigned acknowledges that PHSA and/or MoHS may require repayment of
amounts paid to the undersigned under the AMD Expansion Program on the terms and
conditions set out therein and the undersigned agree to comply with such repayment
terms, as
applicable; and
(g) the undersigned is aware of and has agreed to provide care to Eligible Patients (as
defined in the AMD Expansion Program Document) in accordance with the rotation
schedule set
out in Appendix B to the AMD Expansion Program Document, as may be amended.
The undersigned further acknowledges that the AMD Expansion Program is subject to
modification, adjustment and termination by the Ministry of Health Services for the
Province of
British Columbia and/or PHSA. Unless withdrawn by notice in writing to PHSA, this
Acknowledgement shall also apply to any continuation or replacement of the AMD
Expansion
Program after the expiry of the initial term of the AMD Expansion Program on March
31, 2012.
DATED effective April 1, 2011.
_______________________________
[.INSERT NAME OF LICENSED OPHTHALMOLOGIST WITH RETINAL DISEASE
FELLOWSHIP]
 
 
 

 
 
 
 
 
 
 

 
 
 

 
 
 
 
 
 
 
 
 

2. 2012/13 Provincial AMD program
A revised Provincial AMD Program document is being finalized and will be sent out
shortly. There will be minor changes throughout to reflect the change in the fiscal year
and budget.
In addition, we have made a few other changes based on the recommendations of the
retinal specialists and to best meet the objectives of the Program, namely:
Locums. In order to ensure that the Program does not detract from the vital role and
responsibility that each individual health authority has, we have included provisions
with regard to Locum arrangements as well as a requirement to have privileges from
the
health authority having jurisdiction in the region in which you are providing service.
This
requirement has been requested by a health authority so that they may have an
opportunity to have input into how AMD treatment services are provided in their
region. The wording will be as follows:
“PHSA may, on request from a Program Registrant from time-to-time, permit a
Program
Registrant to utilize one or more locum physicians who are Licensed Ophthalmologists
with Retinal Disease Fellowships (a “locum”) to perform treatments on behalf of a
Program Registrant provided that the Program Registrant remains responsible to
ensure
that such locum complies with the terms of this Program Document in respect of all
Eligible Patients treated by such locum, including the requirement to enter all data in
respect of Eligible Patients treated by such locum into the AMD Database and to
ensure
that an AMD Database Consent has been obtained by all Eligible Patients. In addition,
as
set out in Section 25, since the responsibility to provide regional access to care under
Section 19 and other activities under Section 20 remains with the Program Registrant
(and not the locum), any Administrative Fees that may be claimed by the locum under
Part II of the AMD Expansion Program will be deducted from the maximum
Administrative Fees that such Program Registrant would otherwise have been eligible
to
receive.
No person other than a Program Registrant (and their respective locum physicians
meeting the above criteria) is required to perform the duties under Part II of this
Program Document, nor are they eligible to receive any Administrative Fees or other
benefits under Part II of this Program Document.
As a condition of being and remaining a Program Registrant and receiving
Administrative Fees under Part II of the AMD Expansion Program, each Program
Registrant must:

 obtain and maintain at all times privileges from the health authority having
jurisdiction in the region in which that Program Registrant treats an Eligible
Patient; and
 comply with all terms and conditions attached to privileges granted to the
Program Registrant, as such terms and conditions are specified by the health
authority granting such privileges”.
 
Administration Fees. We have reflected in the document that, in the event of a budget
shortfall, the retinal specialists may unanimously request an alternate recovery
allocation as discussed above.
 
3. Visiting Clinics
a. Cranbrook: Continues to function as originally established (monthly clinics) at the
East Kootenay Regional Hospital.
b. Kelowna: Continues to function as originally established (bi-weekly clinics) at the
Kelowna General Hospital.
c. Nelson: A clinic has been established at the Kootenay Boundary Regional
Hospital.
d. Fort St. John: A monthly clinic commenced March 2012 at the Fort St. John
Hospital.
e. Terrace: Continue to work with Northern Health to establish a Clinic at Mills
Memorial Hospital.

 
4. Supply Chain
As you are aware, several months ago a contamination with an Avastin drug lot
resulted in at least 16 people in the US treated with severe eye infections. To
mitigate any risks in British Columbia, we are requesting the development of supply
chain guidelines. We have requested the major compounding pharmacies to define
best practices in drug preparation and storage of Avastin, Lucentis and Visudyne.
The guidelines will be reviewed by the Joint Accountability Committee and
implemented as a requirement of the AMD Program. All drug suppliers will be
required to comply with the drug preparation guidelines and Retinal Specialists with
the drug storage guidelines. In the longer term, random product sterility audits will
be implemented to ensure compliance to the guidelines. I would ask that you
provide a brief description of your current process from time of receipt of the drug
in your office until it is used. Your Program Registration for 2012/13 will be held until
this information is received.
 

5. Audit
The recent Audit undertaken by PHSA Internal Audit is complete. There are a few
situations that require follow up however for the most part there were no major
issues. I will share the detail of the Report once it has been finalized and reviewed
with the Joint Accountability Committee.
Please contact me if you require further information or clarification.
David
 
 

David Babiuk
AMD Program Administration
604-675-7420 Phone
250-920-6777 Cell
604-708-2720 Fax
700-1380 Burrard Street
Vancouver, BC V6Z 2H3
david.babiuk@phsa.ca
http://www.phsa.ca

 


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