Assisted Reproduction Services:Proposed Changes to the Schedule of Benefits for Physician Services

Ministry Presentation to Physician Services CommitteeAugust 17, 2015Health Services BranchNegotiations and Accountability Management Division

Current StatusUnder the Health Insurance Act (HIA) and its Regulation 552, the Ontario Health Insurance Plan (OHIP) provides payments for medically necessary physician services as listed in the Schedule of Benefits for Physician Services (Schedule). Currently, OHIP insures a number of services related to infertility:

OHIP spends about $20M per year on physician services related to in vitro fertilization (IVF) and intra-uterine insemination (IUI). IVF OHIP insures the first three treatment cycles for women with complete bilateral anatomical fallopian tube blockage not resulting from voluntary sterilization.~1,000 patients/year for an approximate cost of $4M per year .IUI OHIP insures unlimited cycles of IUI for all causes of medical infertility.~10,000 patients/year for an approximate cost of $16M per year.OHIP also insures a number of physician services for diagnosing infertility, as well as a number of surgical services for the correction of infertility.There are also number of non-physician services related to IVF and IUI that are not insured (e.g., embryology services for IVF, sperm washing for IUI, etc.).

Summary of ProposalThe Ministry of Health and Long-Term Care (ministry) is proposing changes to Regulation 552 and the Schedule under the HIA that will remove IVF and IUI as insured services under OHIP:Overview: The ministry is proposing to remove IVF and IUI from the Schedule and therefore remove $20M from the Physician Services Budget (PSB), which will have a positive impact on managing fiscal pressures within the PSB.The ministry is proposing a new $70M program (re-investing the $20M with an additional $50M investment) to fund assisted reproduction services outside of OHIP. The $50M investment is outside the PSB.The program will fund both physician services and non-physician services related to IVF and IUI through Transfer Payment Agreement (TPA) funding contracts with clinics. Physician services in the Schedule related to diagnosing and surgically correcting infertility will remain insured. The proposed effective date of the Schedule changes will be December 1, 2015, and the first round of TPAs will come into effect immediately afterwards, in order to ensure no gap in services for patients.

The proposed change supports key government commitments:Government Commitment

Family Building2007 Platform committed to explore the issue of infertility to make treatment and adoption more accessible and affordable for people, as everyone should have a fair opportunity to create a family.In 2009, the Government-appointed Expert Panel on Infertility and Adoption (EPIA) released its report with 51 recommendations related to infertility, including expanding public funding for IVF services.

Funding for IVF and IUIOn April 10, 2014, the Government of Ontario announced its intention to expand funding of assisted reproduction services by contributing to the cost of one IVF cycle per patient per lifetime for all causes of eligible infertility. IUI would remain funded. On April 30, 2015, the Ontario Legislature passed the 2015 Ontario Budget Building Ontario Up, which approved $70M in funding for IVF and IUI.

The program design was informed by the following:Policy Rationale

Policy Objective: Increase AccessAim to increase access to assisted reproduction services for more people in Ontario. Program will maintain access to IUI for 10,000 patients each year, and will also expand access to IVF from 1,000 patients to over 5,000 patients each year. Program will also add fertility preservation services (oocyte and sperm freezing) for medical reasons (i.e. cancer patients).

Policy Assumption: Social ProgramAssisted reproduction services are not medically necessary and should therefore be funded outside OHIP.Social policy goal is to expand access for assisted reproduction services to all Ontario residents (regardless of age, sex, gender, sexual orientation, or family status), rather than providing services based on a diagnosis of medical infertility.

Program DevelopmentTo inform the development of the expanded program, the ministry completed an advisory process to obtain expertise and advice on clinical services and eligibility.Structure of the Advisory Process: Members included 8 physicians and 2 embryology lab directors with sector expertise, as well as 3 patients with lived experience of infertility. Physician and assisted reproduction sector expertise included: Obstetrics and Gynaecology; Endocrinology, Urology and Andrology; Quality Assurance and Clinical Practice Guidelines; and Fertility Services Program Delivery (Quebec and Israel).Chaired by Dr. Ellen Greenblatt, Medical Director, Mount Sinai Hospital fertility clinic.Three meetings were held between December 2014 and February 2015. Recommendations were provided in a final report to the ministry and were used to inform this proposal.

The advisory process did not address issues related to the funding mechanism, funding levels and pricing.

Program DetailsFund both physician and clinic services through TPA contracts directly with fertility clinics (hospital-based and non-hospital). Fixed budget of $70M per year. Includes physician and non-physician costs.Target of 18 IVF clinics (2 hospital-based) and 36 IUI clinics (8 hospital-based). FundingPatient EligibilityOpen to all patients with an OHIP health card number.Not restricted to medical infertility, but also for social reasons (e.g. same sex couples). Access open regardless of age, sex, gender, sexual orientation, family status, disability, etc.IVF 1 treatment cycle, but with unlimited transfers for all resulting embryos. IUI unlimited cycles, consistent with current policy under OHIP. Surrogates can also receive one additional funded cycle of IVF.Fertility preservation (collection and freezing of sperm/oocyte gametes) will also be provided to patients for medical reasons (i.e. cancer patients). Key elements of the program design are as follows:IVF approximately 5,000 cycles for 5,000 patients.IUI approximately 22,000 cycles for 10,000 patients.Each clinic will be assigned volumes in the TPA, determined based on historical data in the OHIP billing database as well as data provided by clinics.Annual Volumes

Program DetailsMedical assessments;Performing and/or interpreting required laboratory or diagnostic imaging tests;IUI procedure;Oocyte retrieval procedure;Sperm retrieval procedure (i.e., surgical sperm extraction); andEmbryo transfer procedure. Diagnostic imaging services (ultrasound)Physician ServicesKey elements of the program design are as follows:Embryology services to create and grow embryo(s), including fertilization of oocytes with sperm (using traditional IVF or Intra-Cytoplasmic Sperm Injection (ICSI) if medically necessary, Assisted Hatching, and Blastocyst Culture;Embryology services to prepare and freeze embryo(s);Embryology services to thaw and culture embryo(s); andOperating costs, such as the cost of the premises, equipment, supplies, personnel, and all administrative requirements. Non-Physician ServicesPayment for both physician and non-physician services will be made in the TPA.Clinics required to enter into an arrangement with physicians to specify the remuneration for provision of services, and must also set out a dispute resolution mechanism for remuneration issues between the physician and the clinic.Payment

Timelines & Next StepsCabinet CommitteesThe ministry requests that the OMA provide feedback on the proposed amendments to Regulation 552 and the Schedule by August 28, 2015.Following approval, the ministry will release an INFOBulletin detailing the updates to the Schedule, with links to supporting material that will be available on the ministrys website.Consultation on Schedule ChangesThe ministry intends to offer standardized template TPA agreements to the clinics. The clinics are corporate entities, often physician-owned.The TPA will include funding for both physician and non-physician services, and the funding will flow through the clinic. The ministry requests that the OMA advise the ministry by August 28, 2015 what role the OMA would like have on the development of the TPAs.TPA ContractsThis information is presented to the OMA for consultation.

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