BC AMD Expansion Program - Effective April 1, 2010

PROVINCIAL HEALTH SERVICES AUTHORITY (“PHSA”)
 
BRITISH COLUMBIA WET AGE-RELATED MACULAR DEGENERATION TREATMENT EXPANSION PROGRAM EFFECTIVE APRIL 1, 2010

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 on June 1, 2009 and expired on March 31, 2010 (the “Fiscal 2009 AMD Expansion Program”). As set out below, the 2010 AMD Program is effective retroactive to April 1, 2010 and will continue until March 31, 2011 unless amended or terminated earlier as provided for in this Program Document.
 
The Fiscal 2009 AMD Expansion Program 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. In considering whether to continue the AMD Expansion Program after fiscal 2009, and in considering and developing the budget for, and the terms and conditions of, the AMD Expansion Program for fiscal 2010, the MoHS and PHSA sought input from representatives of the group of retinal specialists in British Columbia as to program criteria that would respond to the needs of Wet AMD patients in British Columbia, continue to address improved regional access to care for Wet AMD patients across British Columbia, and continue to improve information and research on treatment options and outcomes within the available fiscal resources.
 
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, 2010. 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, 2010;
(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 has the meaning given to it in Section 8;
(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, 2011. 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, 2011 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, 2011 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 in British Columbia, they have advised MoHS and PHSA of the anticipated number of treatments of Eligible Patients in the Fiscal Year 2010 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 on or before August 23, 2010 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.
 
A Licensed Ophthalmologist with Retinal Disease Fellowship that delivers the signed Acknowledgement to PHSA as set out above is referred to in this Program Document as a “Program Registrant”.
 
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 endeavor 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.

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 or does not become a Program Registrant by August 23, 2010 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. No person other than a Program Registrant 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.

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. As of the Effective Date, such regional visiting centres are provided in Kelowna, Cranbrook and Terrace with 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.

25. ADMINISTRATIVE FEES – MONTHLY REPORTING, PRORATION AND CARRY- FORWARD:

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.

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.

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