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.
 
WEBMASTER'S NOTE: The AMD Patient Chart Form will be uploaded in due course.
 
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
 
Interior Health Authority
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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