Progressing Toward the Regulation of Psychotherapy in Ontario

The regulation of psychotherapy has been more than 10 years in the making but significant strides have been made recently toward full implementation.  Further to the Minister of Health and Long-Term Care’s direction in December of 2017, the College of Registered Psychotherapists of Ontario created a draft regulation identifying therapy modalities that its members could use when providing psychotherapy services. The proposed regulation (under the Psychotherapy Act) was released in April and comments are due by June 15, 2018. The draft regulation is available here: https://www.ontariocanada.com/registry/view_posting.jsp;jsessionid=mAnot1q4ZrYdoGo6sV7mSaT?language=en&postingId=27366

There are six categories of treatment modalities identified in the proposed regulation and they are fairly broad. In order to give some additional clarity to the regulation, and further to the Minister’s direction, the CRPO conducted a public consultation about its draft policy identifying activities that do not fall within the controlled act of psychotherapy. The draft policy is available here: https://www.crpo.ca/wp-content/uploads/2018/03/CRPO-CATG-Consultation-Documents_Consultation-Draft.pdf

Psychotherapists who are not currently registered with an RHPA or social work college whose members are permitted to practise psychotherapy must determine whether their practice falls within one of the broad prescribed modalities identified in the draft regulation; if yes, the practitioner must take steps to become registered with a college permitting such practice (such as the CRPO) or they must take steps to restrict their practice.

In order to provide additional guidance to currently unregulated psychotherapists to help them determine whether they are providing the controlled act of psychotherapy, and therefore whether they need to take steps to register before December of 2019, the CRPO also released a self-assessment tool for providers.  A link to the self-assessment tool is found here https://www.crpo.ca/wp-content/uploads/2018/03/CRPO-CATG-Consultation-Documents_Consultation-Draft.pdf

Prior to the CRPO’s public consultation about the draft regulation, the Health Professions Regulatory Advisory Council reported to the Minister about clarifying the meaning of the controlled act of psychotherapy. That report, entitled “The Therapeutic Relationship as the Cornerstone of Psychotherapy” was released to the public in March of 2018 and is available on the Council’s website.

The CRPO regulation and policy represent a significant move forward toward comprehensive regulation of psychotherapists in Ontario.

For more information, contact Simmie Palter @ spalter@ddohealthlaw.com

Health Sector Payment Transparency Act, 2017

Status

Schedule 4 of Bill 160 enacts the Health Sector Payment Transparency Act, 2017 (the “Act”). On December 12, 2017, the Act received Royal Assent, but has not yet been proclaimed in force.

Purpose of the Act

The purpose of the Act is to require the reporting of information related to financial relationships that exist within Ontario’s health care system. The purpose is also to enable the collection, analysis and publication of that information in order to, among other things:

  • strengthen the transparency to sustain and enhance patients’ trust in both the health care system and health care providers, and
  • allow patients to make informed decisions about their health care by providing them with access to information.

The Act is similar to the Physician Payments Sunshine Act found in the United States and is the first of its kind in Canada. The Act calls attention to the financial relationship between the medical industry (such as pharmaceutical and medical device companies) and those involved in the health care sector (individuals and organizations) – it creates a regime that requires mandatory disclosure of private sector payments to health professionals. As part of Bill 160, the Strengthening Quality and Accountability for Patients Act, 2017, the Act aims to enhance transparency, accountability, and the quality of care across the health care sector.

Requirements of the Act

The Act requires a “payor” to report to the Minister of Health and Long-Term Care (the “Minister”) information related to a “transfer of value” provided to a “recipient”, whether directly or indirectly through an intermediary. Intermediaries and affiliates may also be required to make reports, if requested by the Minister. The Act describes a payor as any of the following persons if the person provides a transfer of value to a recipient:

  1. A manufacturer that sells a medical product under the manufacturer’s own name or under a trade-mark, design, trade name or other name or mark that is owned or controlled by the manufacturer and that fabricates, produces, processes, assembles, packages or labels the product, even if those tasks are performed by someone else on the manufacturer’s behalf.
  2. A person who fabricates, produces, processes, assembles, packages or labels a medical product on behalf of a manufacturer described in #1.
  3. A wholesaler, distributor, importer or broker that promotes or facilitates the sale of a medical product.
  4. A marketing firm or person who performs activities for the purposes of marketing or promoting a medical product.
  5. A person who organizes continuing education events for members of a health profession on behalf of a manufacturer described in #1.
  6. A prescribed person or entity.

Note other relevant definitions:

  • “Transfer of value” means a transfer of value of any kind, including a payment, benefit, gift, advantage, perquisite or any other prescribed benefit.
  • “Recipient” means a prescribed person, as per the regulations, that receives a transfer of value from a payor.

The Act requires the following information to be reported:

  1. The name of the parties to the transaction.
  2. The source of the transfer of value (if requested).
  3. The parties’ respective business addresses.
  4. The date of the transfer of value.
  5. The transfer of value’s dollar value (or its approximate dollar value, if it is a non-monetary transfer of value).
  6. A description of the transfer of value (including reasons).
  7. Any other prescribed information.

The Act also requires the Minister to analyse the information that is reported for the purposes of health system research and evaluation, planning, and policy analysis. The Minister is allowed to disclose the information reported at least once in a calendar year. Furthermore, the Act establishes a framework for inspections and other compliance mechanisms.

Draft Regulations

In February 2018, draft regulations under the Act were published by the Ontario Government. Details found within the draft regulations include, among other things:

  • a list of 31 persons/entities that constitute recipients, including regulated health professionals; hospitals under the Public Hospitals Act and the Private Hospitals Act; psychiatric facilities under the Mental Health Act (subject to exceptions); a not-for-profit entity that operates a family health team or community mental health and addiction services; a licensee under the Long-Term Care Homes Act, 2007; a College under the Regulated Health Professions Act, 1991; a board member, director, trustee, officer, appointee, employee, or agent of a prescribed entity within this definition; etc.
  • a list of 24 items that are considered reportable transfer of values under the Act, such as cash or cash equivalents, honoraria, compensation for services, rebates and discounts, membership fees, supplies and equipment, food and beverages, travel and accommodation, personal gifts, royalties, etc.
  • the definition of intermediary – a person or entity is deemed to be providing or facilitating a transfer of value on behalf of a payor if the transfer of value originates from the payor (irrespective of whether the payor directs how the transfer of value is to be used by the intermediary or is aware of the identities of the recipients at the time the transfer of value is provided to the intermediary)
  • the monetary threshold for reporting a transfer of value set at $10 or more, and other exceptions to reporting requirements
  • other reporting requirements related to the classification of the transfer of value
  • new entities under the definition of payor, including community pharmacies and laboratories
  • the manner and frequency of reporting – every payor must report to the Minister every year, no later than June 30 in any year after 2019 for the previous calendar year.

Penalties

Penalties will be imposed on individuals and corporations for contravening the Act for each day or part of a day on which the offence occurs or continues to occur. These will range from $10,000-$25,000 for individuals and $50,000-$100,000 for corporations. However, a defence of due diligence is applicable in cases where all reasonable steps were taken to prevent the contravention, or at the time of the contravention, the person had an honest and reasonable belief in a mistaken set of facts which, if true, would have resulted in there not being any contravention.

Professionalism and the Public Interest

The Alberta Court of Appeal recently confirmed a health profession regulator’s authority to enact regulations in the public interest, even if no harm is occurring. In Sobey’s West v. College of Pharmacists of Alberta (2017 ABCA 36), Sobey’s sought judicial review of a College policy (incorporated into a regulation to give it the force of law) that prevented pharmacies, pharmacists and pharmacy technicians from offering inducements to clients that required the intervention of a pharmacist or pharmacy technician. Sobey’s acquired Safeway and continued Safeway’s policy of permitting Air Miles loyalty points to be collected by clients filling prescriptions at their pharmacy. While no complaints were made to the College about the loyalty points program, Sobey’s West sought judicial review of the policy, arguing that it curbed competition. At the time, Sobey’s West was challenging a similar policy in the court in British Columbia.

The Alberta Court of Queen’s Bench (the trial division in Alberta) found that the College’s policy was ultra vires (outside the authority of) the College. The Alberta Court of Appeal reversed the trial judge’s decision, indicating that the College has legislative authority to enact law that protects the public interest. Therefore, the policy prohibiting the collection of Air Miles loyalty points on prescription drug purchases was within the jurisdiction of the College. This decision is consistent with Sobey’s West v. College of Pharmacists of B.C. (2016 BCCA 41), where the B. C. Court of Appeal found a similar college policy was within the authority of the College to make (and reversed the B.C. trial division decision).

The reasoning of these decisions is consistent with the Supreme Court of Canada’s decision in Katz Group Canada Inc. v. Ontario (Health and Long‑Term Care) (2013 SCC 64), where the Supreme Court of Canada upheld provincial drug benefit legislation and regulations whose intent was to increase transparency in generic drug pricing on the grounds that the regulations were consistent with the stated purpose of the enabling legislation.  The court explained, in a unanimous decision, that to be found ultra vires, regulations must be shown to be inconsistent with the objective of the enabling statue or the scope of the statutory mandate. The court noted that there is a presumption of validity regarding regulations, which means that the regulations should be reconciled with the enabling statute in manner that is possible to construe them as intra vires and that the onus of proving them ultra vires is on the challenger – not on the rule-maker to justify them.  The court also makes a point of noting that it is not the court’s role to assess the policy merits of the rules nor the partisan, social, or economic issues that may have been the catalyst for their creation.

Does the decision of the Alberta Court of Appeal, together with the Supreme Court of Canada’s presumption of validity for regulations, imply that regulators have a wide berth to enact restrictive rules as a matter of public interest, and that such rules will be difficult to challenge on judicial review?  While regulators do have considerable latitude to enact regulations as a matter of protecting the public, each challenge to a regulation will turn on the particular wording of the regulation or policy in question, and on the precise wording of the enabling statute.  In the past, regulations preventing the charging of block fees by physicians were judged to be ultra vires the Medicine Act because the court found they were made for the purpose of preventing extra-billing rather than for protecting the public, thus departing from the statutory mandate. See:  Szmuilowicz v. Ontario (Minister of Health), (1995) 125 D.L.R. (4th) 688 (Gen. Div.).

Similarly, regulations preventing dentists from advertising their services using content that was informational, accurate, and helpful to individuals choosing a dentist were struck down as contrary to the right to freedom of expression protected by the Charter: see Rocket v. Royal College of Dental Surgeons of Ontario, (1990) 71 D.L.R. (4th) 68 (S.C.C.).

In a third case, regulations preventing inactive physiotherapists from practising beyond their scope of practice were found by the court to be unauthorized:  see Lefko v. College of Physiotherapists of Ontario, (1998) 116 O.A.C 86 (Div Ct).

These cases show that professional regulations are not impossible to successfully challenge.

Consequently, it is recommended that regulators, when seeking enactment of such rules into legislation, carefully draft the proposed rules to ensure that they are consistent with the regulator’s statutory mandate and do not exceed the scope of authority granted by the enabling legislation.

For help in drafting regulations for health professions, please feel free to get in touch: spalter@ddoheatlhlaw.com.

Nurse practitioner’s role now includes prescribing controlled substances

Nurse practitioners (NPs) fill an important gap in our health care system. In 2007, the first Ontario NP-led clinic opened its doors in Sudbury, and dozens more are now in operation in Ontario.

On April 19, 2017, the role of NPs was expanded. Provided the NP successfully completes the required education, NPs have the authority to prescribe medical cannabis and substances that may be used for medical assistance in dying (MAID).  The education must be approved by the governing council of the College of Nurses of Ontario and must be specifically designed to educate NPs to safely, effectively and ethically prescribe controlled substances.

Before prescribing can occur:

  1. there must be a nurse-patient relationship between the NP and the patient;
  2. the intended use of the substance can only be therapeutic; and
  3. certain information must be contained in the prescription, a copy of which must be retained as part of the patient’s health records.

To see more information, click here http://www.cno.org/en/news/2017/april-2017/nps-can-now-prescribe-controlled-substances/ or access the Nursing Act general regulation: https://www.ontario.ca/laws/regulation/940275#BK39.

Bill 84, the Medical Assistance in Dying Amendment Act, includes limited immunity for NPs who assist with MAID.  NP-led clinics are also given limited immunity in relation to the delivery of MAID. Bill 84 received Royal Assent and became law on May 10th.

For advice concerning NPs in your health care organization, contact Simmie: spalter@ddohealthlaw.com.