My Lords, the regulations that we are now considering, which were laid before this House on 4 July, exempt some types of providers of NHS services from the requirement to hold a licence from Monitor. Providers who will not be required to hold a licence are as follows: NHS trusts; providers which are not required to register with the Care Quality Commission; small providers of NHS-funded healthcare services whose annual turnover from the provision of NHS services is less than £10 million; providers of primary medical and dental services; and providers of NHS continuing healthcare and NHS-funded nursing care.
The Health and Social Care Act 2012 gave Monitor a new role in regulating providers of NHS services, and the licence is a key tool for Monitor in carrying out its new functions. The Act strengthens sector regulation by building and improving on Monitor’s previous role as the regulator of foundation trusts and makes sector regulation more comprehensive by extending Monitor’s role to all providers of NHS services. While the 2012 Act allows licensing to apply to all providers of NHS services, these regulations provide for exemptions to this requirement for certain types of provider where the licence would not give additional protection for patients or would impose an unfair burden on providers.
Regulation 2 defines a licence holder as the legal entity responsible for delivering NHS services to patients, the body receiving NHS funding and providing care directly to patients. This approach mirrors that for CQC registration. Regulation 2 also ensures that, where a provider has subcontracted elements of a service, the subcontractor is considered a separate entity and thus in need of a licence.
Regulation 3 confirms that no exemptions apply to foundation trusts. This is consistent with the position under the 2012 Act that all foundation trusts must hold a licence.
Regulation 4 provides that NHS trusts will not be required to hold a licence. This is because directions from the Secretary of State require the NHS Trust Development Authority to set and enforce requirements on NHS trusts similar to those set by Monitor's licence. The NHS Trust Development Authority must seek and consider advice from Monitor in setting these conditions to ensure that the requirements for NHS trusts will provide similar protection for patients’ interests compared with those set by Monitor through the licence.
Under Monitor’s licensing regime, a commissioner may request that a service be subject to additional regulation to ensure patients’ continued access to that service. Any provider of such commissioner-requested services will not be eligible for an exemption under the regulations even if the provider otherwise qualifies for an exemption. Where commissioners have designated a service as a commissioner-requested service, Monitor must be able to intervene in order to secure continuity of that service. I should highlight to the House that this particular override would not apply to NHS trusts because the NHS Trust Development Authority will be able to undertake similar interventions on an NHS trust which becomes unsustainable. Regulation 9 provides for this.
Regulation 5 provides for an exemption from the requirement to hold a licence for providers of primary medical or primary dental services under contractual arrangements made under Parts 4 and 5 of the National Health Service Act 2006 with NHS England. NHS England will ensure that such providers comply with requirements that will ensure equivalent protections for patients.
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Regulation 6 ensures that providers of nursing care, which is defined in the regulations as,
“NHS Continuing Healthcare or NHS funded nursing care”,
will not be required to hold a licence. An increasing number of providers of adult social care attract NHS funding for nursing care as part of a social care package. This avoids pre-empting the proposals in the Care Bill for market oversight of providers of adult social care. This exemption is time-limited to 31 March 2015, and the department will review it and determine whether it should continue to apply beyond that point.
Providers that are not required to register with the Care Quality Commission will not be required to hold a licence. Providers are prioritised for registration by the CQC on the basis of potential risk to patients. The department will keep this position under review; in particular, we will consider potential changes to the scope of CQC registration.
Regulation 8 exempts providers with less than £10 million annual turnover from the provision of NHS services. It is the Government’s policy to avoid regulatory burden on small and micro enterprises. Regulation 8 also defines applicable turnover for the purposes of the £10 million threshold as turnover from the provision from NHS services. Consistent with the exemptions provided for by Regulations 5 and 6, turnover from the provision of primary medical and primary dental services provided under Parts 4 and 5 of the NHS Act 2006 and from nursing care is not considered applicable turnover.
Regulation 9 provides that, where NHS England or a clinical commissioning group considers that a service is a commissioner-requested service, the provider ceases to qualify for an exemption under Regulations 5, 6, 7 or 8. Regulation 9 also sets a condition on exemptions conferred by Regulations 5, 6, 7, or 8 and provides for the Secretary of State to withdraw exemptions from a provider that does not comply with the conditions.
These regulations allow Monitor to carry out its regulatory duties through the licence in a targeted and proportionate way, while ensuring that patients’ interests are always the overriding factor. I commend the regulations to the House. I beg to move.