Regulatory Outlook: Life Sciences and Healthcare – November 2016

Written on 29 Nov 2016

Current Issues

Brexit and access to healthcare: Aside from the question of how much money the NHS will receive once Brexit occurs, the key questions are: will UK citizens still be entitled to a European Health Insurance Card and access to state-provided healthcare when visiting an EEA country? And what will happen to EEA visitors to the UK?

Brexit and staffing – freedom of movement: A significant number of EU citizens work for the NHS and social care providers. At a time when recruitment of permanent staff is difficult in this sector, if Brexit affects the flow of these workers to the UK (and/ or the recognition of their qualifications), then the UK may face a catastrophic skills shortage.

Apprenticeship levy: Many are looking at the 2017 apprenticeship levy as a way to solve the sector’s staffing crisis and not merely as a matter of statutory compliance. Whether employers become an employer-provider (who develop and deliver their own training) or look to external providers/ programmes, apprenticeship training in the sector is likely to improve career prospects and the quality of care.

The National Living Wage (NLW): Six months on from the introduction of the NLW for the over 25s, the social care sector is still getting to grips with the increase in its cost base. Despite fears that providers’ financial viability would be jeopardised (with low profit margins already being squeezed) and workers’ hours would be cut, these challenges appear to have been balanced by uplifts in local authority fees. Reports suggest a positive effect from NLW, particularly in the under 25s, whose pay has also increased.

Regulatory costs: Providers are focusing more than ever on regulatory compliance and the offences and costs attached to the same. As well as the newly introduced Care Quality Commission (CQC) fees for registration, the market is facing increased potential financial liabilities for non-compliance. Since April 2015, CQC’s powers have changed and it has updated its enforcement policy – in certain circumstances, the maximum limit on fines has been removed. More recently, the changes to sentencing guidelines for (general) health and safety offences means fines are now influenced by a provider’s turnover in addition to the level of harm and culpability.

In Focus: Enforcement

Enforcement is a key role of the CQC, which is the independent regulator of health and social care in England. CQC is responsible for the safety and quality of treatment and care involving patients and service users in receipt of a health or adult social care service from a provider registered with CQC.

In broad terms, CQC registration is required for any of the following:

  • treatment, care and support provided by hospitals, GPs, dentists, ambulances and mental health services; – treatment, care and support services for adults in care homes and in people’s own homes (both personal and nursing care); and
  • services for people whose rights are restricted under the Mental Health Act.

CQC’s core functions are: to register providers (subject to payment of fees); to monitor, inspect and publicly rate them; and to enforce breaches of the regulations. CQC adheres to an enforcement policy and ‘decision tree’: it will only take action that it judges to be proportionate and, generally, will only intervene if people are at an unacceptable risk of harm or providers are repeatedly or seriously failing to comply with their legal obligations.

There is a memorandum of understanding between the CQC, the Health and Safety Executive (HSE) and local authorities to cover the overlap of their inspection and enforcement functions. The latter entities are responsible for health and safety matters involving: (a) patients and service users who are in receipt of a health or care service from providers not registered with CQC; and (b) workers, visitors and contractors, irrespective of registration.

NHS Improvement (NHSI) provides another layer of oversight of foundation trusts, NHS trusts and (independent) providers of NHS-funded care. NHSI is an amalgam of previous entities, but its emphasis has changed to prioritise support to providers and local health systems to help them improve. It still regulates competition in the health sector and has a memorandum of understanding with the Competition and Markets Authority for the investigation and enforcement of such matters in the sector under competition law.

CQC’s approach to enforcement is viewed as being more ‘softly-softly’, when compared to other regulators, such as the HSE. It has also been challenged in the courts recently in terms of the application of CQC’s own quality ratings review, and in particular a number of CQC’s pre- and post-publication processes. CQC is implementing the recommendations from the judgment in respect of its factual accuracy process, but the judgment may give further confidence to other providers to challenge inspection reports and ratings.

Dates for the diary

October 2016 onwards

Implementation of Sustainability and Transformation Plans within relevant STP footprints in England. Health and care organisations within defined areas have been obliged to develop plans to “drive genuine and sustainable transformation in patient experience and health outcomes of the longer-term”.

6 April 2017

Introduction of the apprenticeship levy. Providers in the health and social care market will need to budget for the levy and review its existing training programmes and internal systems and processes.

1 August 2017

All new pre-registration nursing, midwifery and allied health professional students will receive their funding and financial support through the Student Loans Company rather than through the current NHS bursary scheme and HEE funded tuition.

For more information and details of all of the other areas covered by the Regulatory Outlook click here