The Health and Social Care Act 2012 gave Monitor a new role in regulating provision of NHS services and an overarching duty to protect and promote the interests of patients by promoting NHS provision that is economic, efficient and effective. These regulations provide key details that enable Monitor to carry out its new functions of licensing providers of NHS services and regulating the prices payable by commissioners for NHS services, in order to protect and promote patients’ interests.
The licence is a key tool by which Monitor will regulate providers of healthcare services for the NHS. Monitor has now taken on its new licensing powers in relation to foundation trusts and we expect this to extend to other providers of NHS services from April 2014.
A provider’s licence is made up of licence conditions that set out the requirements providers must meet if they wish to provide NHS services. In future, all providers of NHS services must hold a licence unless they are exempt under separate regulations, which were laid before the House on 4 July.
Monitor published its first set of standard licence conditions in February this year, after approval by the Secretary of State for Health. They include standard conditions such as requiring licensees to provide information to Monitor, which will apply to all licence holders, or to particular types of licence holder, such as conditions applying to providers whose services are designated as a commissioner-requested service. There are also special conditions that will apply to an individual provider, such as conditions for NHS foundation trusts. The Act sets out a process that Monitor must follow in order to either modify a standard licence condition or include a new standard licence condition that applies to all licences, or licences of a particular description.
These regulations allow the Secretary of State to determine the extent to which licence holders should be able to influence Monitor on any changes to the standard licence conditions, to ensure a balance between allowing real concerns to be addressed and not imposing unnecessary delays to the licence modification process.
Monitor intends to engage potentially affected licence holders on the scope and scale of any changes to the standard licence conditions before reaching the statutory process, much as it did when engaging on the first set of standard licence conditions.
The statutory process then ensures that there will be proper engagement with affected licence holders and other relevant bodies about any change to the standard licence conditions, and includes a statutory check on Monitor’s ability to change the standard licence conditions. This check comes in the form of an ability for licence holders who would be affected to object to the change.
The regulations set the two objection thresholds at 20% of licence holders or 20% of market share of NHS provision. If either threshold is met, Monitor will be unable to make the change. However, Monitor may refer the issue to the Competition Commission. Monitor could make the changes only if the Competition Commission judged that the changes were in the public interest.
I turn to the second aspect of these regulations. Monitor has powers to take action where a person—which may be a licence holder, an exempt provider, NHS England or a clinical commissioning group—has not complied with a request for information documents, records or other documents that it considers necessary for Monitor to carry out its regulatory functions. Monitor also has powers to take action where a provider is in breach of the requirement to hold a licence or a condition of the licence.
The Act sets out Monitor’s powers to impose three different types of discretionary requirements, and I remind the Committee of them as a refresher. The first is a variable monetary penalty of such amount as Monitor may determine, up to 10% of the organisation’s turnover in England. The second is a compliance requirement, or, in other words, action to stop the breach in question or to ensure that it does not happen again—for example, a requirement that a provider ceases plans to dispose of an asset needed for the provision of a specified service. The third is a restoration requirement, an action to revert to the position before the breach occurred. For example, Monitor could require that a provider reopen a service that it had closed in breach of a licence condition.
Monitor’s guidance sets out how it will determine the use of its enforcement powers, including fines, and these regulations set the definition of turnover that Monitor will use when determining the level of fines. Simply put, providers’ turnover is defined as their turnover from NHS income. The turnover of clinical commissioning groups and NHS England is defined in terms of administrative spend; total spend would be vastly disproportionate.
I turn to the final aspect of the regulations. The Government want to ensure that the health system delivers better health, better care and better value for money. Better value for money and more accurate pricing will be a key part in delivering enhanced services to patients and in equipping the NHS to improve standards. The new system will drive improvement through providing mechanisms to ensure that prices better reflect costs of supply, incentivise better data
recording and collection and make available better incentives and stronger compliance mechanisms. Monitor will have the specific duty of promoting healthcare services that represent value for money and maintain or improve quality. Monitor will achieve this by working with NHS England to regulate prices and set rules for determining prices for local pricing and flexibilities.
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NHS England will set the scope of the tariff and define “units of service” for which prices or rules will be specified. NHS England will also set rules for determining local variations. At all stages, Monitor and NHS England will have to agree elements of the tariff with each other.
The Act includes a new statutory basis for providers and commissioners to raise formal objections to the methodology that Monitor proposes for calculating national prices. It is very like the process that I have described for objecting to modifications to licence conditions. Following comprehensive engagement, Monitor will be required to publish a final draft of the national tariff and allow 28 days for commissioners and providers to object formally to the proposed methodology for calculating national tariff prices for specified services.
Following the consultation, Monitor will calculate the percentage of commissioners objecting, the percentage of providers objecting and the percentage share of supply held by the objecting providers, which allows providers’ objections to be weighted proportionate to the nationally priced services that they deliver. If the threshold for any of these three types of objections is met, Monitor has three options. Monitor may drop the proposed methodology in light of the objections received; it may put forward alternative proposals in the light of the objections received, and publish these for consultation; or, it may refer the proposed methodology to the Competition Commission, which would then be required to investigate and report on whether the proposal was appropriate.
These regulations set the three objection thresholds, each one at 51%. The thresholds are higher than for licensing. This is because the threshold for licensing was based on precedents for objections to licence changes in other sectors, but there are no precedents for price-setting. The department proposed a higher threshold for pricing because the group of potential objectors is wider there. Following consultation, the department has concluded that setting the thresholds at this level will effectively balance the interests of patients, while protecting commissioners and providers from a pricing methodology that could be unfair.
These regulations will help to enable Monitor to undertake fair and proportionate regulatory action, and will support a fair and transparent system for setting tariff prices. I commend the regulations to the Committee.