Ministerial Brief by the Minister of Health and Seniors, the Hon. Jeanne Atherden, CA, CPA, JP, MP

Overview of the Bill

Mr Speaker, on the 24^th June 2016 I tabled in this Honourable House:

• the Bermuda Health Council Amendment Act 2016,
• the Bermuda Health Council (Health Service Providers) (Licensing) Regulations 2016; and
• the Bermuda Health Council (Health Service Providers) (Health Technology) Regulations 2016.

Mr Speaker, today I will present for debate the Bermuda Health Council Amendment Act 2016.

The Bill prepares for the coming into force of Section 13 of the Bermuda Health Council Act 2004 (“the Act”), which authorizes the Bermuda Health Council (“the Council”) to licence health service providers. The Bill amends the Act to support this enactment, including provisions to:

• require all health service providers to have a licence to operate,
• prohibit financially vested referrals, and
• regulate the importation of high risk health technology into Bermuda.

Mr Speaker, the Bill brings into effect the existing authority for the Council to issue health service providers a licence to operate under Section 13 of the Act.  Note, Mr Speaker, that the term “health service providers” refers to healthcare businesses, not to healthcare professionals. This is an important distinction.

Professionals are already regulated by statutory Boards and Councils. However, once a professional is licensed, there is no other requirement for them to open and operate a healthcare business, beyond the standard employment and environmental health requirements.

This has led to a proliferation of healthcare businesses with no controls and limited accountability. The consequence has been a profit-led growth in healthcare businesses, rather than growth based on population clinical needs. Note, Mr Speaker, that the two are not always the same and, unfortunately, this has both compromised the quality of some services and increased utilization of some procedures without medical justification.

Mr Speaker, a very important feature of this Bill is that it provides for the regulation of self-referrals and financially-vested referrals. While it is clear that some self-referrals are appropriate and improve access for patients; close monitoring of utilization and referral patterns have made it evident that unchecked self-referrals can lead to unnecessary use of some procedures, which is not good for patients and increases healthcare costs. This Bill provides for such referrals to be regulated, while protecting clinically-appropriate testing that enables patient access and quality service.

Accordingly, Mr Speaker, the Bill provides for measures for the Council to monitor interests in order to control self-referrals and financially-vested referrals. Permission can be obtained from the Council for a time limited exemption if the referrals are medically necessary and clinically appropriate, and insurers can be granted permission to require providers to prove financially vested referrals are medically necessary. 

Mr Speaker, to support enactment, the Council will establish a register of interests and publish information related to the exemptions granted.  The Council will be required to collaborate with stakeholders to develop and publish a Code of Practice which would be used to guide procedures for managing financially vested referrals.

Mr Speaker, the existing Bermuda Health Council Act 2004 already provides for the making of Regulations to govern the licensing of health service providers. Such regulations have been tabled and will be presented in detail at a later time this month.

By way of summary, the proposed Bermuda Health Council (Health Service Providers) (Licensing) Regulations 2016 (or “Licensing Regulations” henceforth) will enable the Council to issue a licence to operate to each health service provider, or healthcare business, and provide for the Council to attach conditions or restrictions to a licence, and procedures for a licence to be denied, cancelled or suspended.

In addition, Mr Speaker, the Bill provides for a new function necessary to contain healthcare costs; namely for the Council to monitor the use and importation of health technology.  Importing high risk health technology – specifically high risk medical equipment – will be prohibited unless a person obtains permission and a certificate of entry from the Council. The Council will have authority to attach conditions to the certificate of entry.   

To enable enforcement of these powers, the Bill permits the Council to inspect health service providers and relevant records after providing notification to providers. And any provider who obstructs an inspector is liable to a fine.  

Accordingly, the Bill provides authority to the Minister to make regulations for the entry of health technology and the licensing of providers. Such regulations have been tabled and will be presented in detail at a later time this month.

By way of summary, Mr Speaker, the proposed Bermuda Health Council (Health Service Providers) (Health Technology) Regulations 2016 (or “Health Technology Regulations” henceforth), will enable the Council to review applications for high risk health technology prior to importation, and issue a certificate of entry in the spirit of health system planning and to further protect patient safety.  This refers to specific types of medical equipment.

Finally, Mr Speaker, the Bill requires consequential amendments to the following legislation:

1. Public Health Act 1949 - includes a definition of “high risk health technology facility” and authorizes the Department of Health to register facilities which operate high risk health technology 
2. Radiation Act 1972 - provides authority for the Minister to issue certificates of entry for radiation emitting equipment used by health service providers.
3. Health Insurance (Health Service Providers and Insurers (Claims)) Regulations 2012 - removes the provision that allows the Council to refuse to register a provider if a penalty is unpaid. All penalties relating to health services providers will now be set out in the Licensing Regulations. 
4. Health Insurance (Standard Health Benefit) Regulations 1971 - amends language to ensure alignment with the Bill.

Mr Speaker, this concludes my summary of the Bermuda Health Council Amendment Bill.

Before closing, Mr Speaker, I would only like to remind this Honourable House that Section 13 of the Bermuda Health Council Act 2004 has included from inception the authority to license health service providers. This section had not been brought into effect, but the Council began consulting with stakeholders in 2007, with a formal framework for licensing health service providers presented in 2010.  Extensive consultation took place with statutory bodies, and professional associations at that time, with the hospital assisting in the piloting of the framework for high risk health technology. 

The regulatory framework was further revised based on consultation and since 2015, additional consultation has occurred with all healthcare professional bodies, professional associations, unregulated professionals, insurers, government departments, the hospital, and local charities. Consultation included group and individual meetings with all regulated and unregulated professional groups and insurers; and posting a consultation paper on the Council’s website. 

Furthermore, Mr Speaker, the Council also consulted with stakeholders while facilitating a voluntary registration process in September 2015 in which 246 providers out of an estimated 334 eligible providers voluntarily registered with the Council.  In January 2016, their names were listed on the Council’s website.  The registration process was based upon some of the legislative requirements noted in the Regulations.

Mr Speaker, I can assure my honourable colleagues that the majority of providers are supportive of the proposed regulatory changes, while a few physicians have been strongly opposed based on concerns about the capacity of the Council to make determinations about issuing a licence, and clarity of the regulatory guidelines.

The Council has listened to their concerns and put in place measures to ensure it has appropriate capacity and technical expertise to evaluate businesses, and will publish guidelines to clarify requirements and ensure transparency. Indeed, the Council’s current voluntary registration on its web site, already provides details on how the assessments are done.

In addition, Mr Speaker, the Council has partnered with the Pan American Health Organization (PAHO) and the Ministry to engage international subject matter experts as required, developed procedures which incorporate specialized medical expertise, and embedded decision making in committee format in which members are local subject matter experts. 

Mr Speaker, this concludes my brief and I hereby introduce   

• the Bermuda Health Council Amendment Act 2016,
• the Bermuda Health Council (Health Service Providers) (Licensing) Regulations 2016; and
• the Bermuda Health Council (Health Service Providers) (Health Technology) Regulations 2016.

to this honourable House on behalf of the Ministry of Health and Seniors.

Thank you, Mr Speaker.