Procedure for controlled locality determinations (Rurality01)

Procedure for controlled locality determinations (Rurality01)

Procedure for controlled locality determinations (Rurality01) Standard operating policies and procedures for primary care Issue Date: June 2013 Document Number: OPS_2029 Prepared by: Primary Care Commissioning (PCC) Status: Approved Next Review Date: June 2014 Page 2 of 17

Information Reader Box Directorate Medical Nursing Patients & Information Finance Purpose Tools Guidance Resources Consultations Operations Commissioning Development Policy Human Resources Publications Gateway Reference 00220 Document Purpose Document Name Standard operating policies and procedures for primary care Publication Date June 2013 Target Audience Additional Circulation List Description Cross Reference Superseded Document Action Required Timing/Deadlines Author All NHS England Employees n/a n/a n/a To Note n/a Primary Care Commissioning 1N04, Quarry House, LEEDS E-mail: england.primarycareops.nhs.net Status: Approved Next Review Date: June 2014 Page 3 of 17

Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Status: Approved Next Review Date: June 2014 Page 4 of 17

Contents Information reader box 3 Document status 4 Contents 5 Purpose of Procedure 6 Procedure aims and objectives 7 Background 7 Scope of the procedure 8 Procedure for controlled locality determinations 8 Monitoring and review of policy 11 Annex 1: Abbreviations and acronyms 12 Annexes 2 to 8 15 Version control 16 Purpose of procedure Status: Approved Next Review Date: June 2014 Page 5 of 17

1 NHS England is responsible for direct commissioning of services beyond the remit of clinical commissioning groups, namely primary care, offender health, military health and specialised services. 2 This document forms part of a suite of policies and procedures to support commissioning of primary care. They have been produced by Primary Care Commissioning (PCC) for use by NHS England s area teams (ATs). 3 The policies and procedures underpin NHS England s commitment to a single operating model for primary care a do once approach intended to ensure consistency and eliminate duplication of effort in the management of the four primary care contractor groups from 1 April 2013. 4 All policies and procedures have been designed to support the principle of proportionality. By applying these policies and procedures, Area Teams are responding to local issues within a national framework, and our way of working across NHS England is to be proportionate in our actions. 5 The development process for the document reflects the principles set out in Securing excellence in commissioning primary care 1, including the intention to build on the established good practice of predecessor organisations. 6 Primary care professional bodies, representatives of patients and the public and other stakeholders were involved in the production of these documents. NHS England is grateful to all those who gave up their time to read and comment on the drafts. 7 The authors and reviewers of these documents were asked to keep the following principles in mind: Wherever possible to enable improvement of primary care To balance consistency and local flexibility Alignment with policy and compliance with legislation Compliance with the Equality Act 2010 A realistic balance between attention to detail and practical application A reasonable, proportionate and consistent approach across the four primary care contractor groups. 8 This suite of documents will be refined in light of feedback from users. 1 Securing excellence in commissioning primary care http://bit.ly/mjwrfa Status: Approved Next Review Date: June 2014 Page 6 of 17

9 This document should be read in conjunction with: The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and accompanying DH guidance The rurality and related determinations policy Procedure aims and objectives 10 The purpose of this procedure note is to ensure that determinations made under regulations 36 to 39 are in line with the requirements of the NHS (Pharmaceutical Services and Local Pharmaceutical Services) Regulations 2013. It is to be used when making a determination as to whether or not an area is, or is part of, a controlled locality. This determination may be as a result of a request from the local medical committee (LMC) or local pharmaceutical committee (LPC), or where the pharmaceutical services regulations committee is satisfied it is necessary to make such a determination. 11 This procedure note should not be used in connection with the determination of a routine application that is, or may be, in a controlled locality. In that instance please refer to the procedure Rurality02 and the relevant market entry procedure note. Background 12 A controlled locality is an area that has been determined by NHS England, a predecessor organisation or on appeal by the NHS Litigation Authority s Family Health Services Appeal Unit (FHSAU), to be rural in character. For the rest of this document, reference is only made to NHS England as a formal determining body but ATs should bear in mind the other bodies that could have reached such determinations. 13 There is no prescribed way to define what is rural in character. Each case must be judged on individual circumstances and will depend on various factors. 14 A rural area is normally characterised by a limited range of local services. The pharmaceutical services committee may determine a range of factors (relevant at the time of the determination) when deciding whether an area is rural. These have been clarified over the years and include: Status: Approved Next Review Date: June 2014 Page 7 of 17

environmental the balance between different types of land use; employment patterns (bearing in mind that those who live in rural areas may not work there); community size and distance between settlements; the overall population density; transportation the availability or otherwise of public transport and the frequency of such provision including access to services such as shopping facilities; and the provision of other facilities, such as recreational and entertainment facilities. 15 Pharmaceutical services regulations committees may find the Department for Environment, Food and Rural Affairs Rural Strategy s definition of rurality 2 useful. Scope of the procedure 16 This procedure applies to determinations made by NHS England relating to controlled localities in England. Procedure for controlled locality determinations 17 1. Where the pharmaceutical services regulations committee is considering making a determination as to whether or not an area is a controlled locality, or is part of one, refer to the controlled locality determinations database. If the area has not been determined in the last five years advise the pharmaceutical services regulations committee that the process to make the determination may start. Record the intention to make a determination in the database and go to paragraph 8. If the area has been determined in the last five years advise the pharmaceutical services regulations committee that it will first need to satisfy itself that there has been a substantial change in circumstances in relation to that area since the determination was made. Record the 2 http://tinyurl.com/cgnetva Status: Approved Next Review Date: June 2014 Page 8 of 17

intention to make a determination in the database and go to paragraph 3. 2. If the LMC or LPC applies in writing for NHS England to determine whether or not an area is to be, or to be part of, a controlled locality, refer to the controlled locality determinations database. If the area has not been determined in the last five years advise the pharmaceutical services regulations committee that the process to make the determination may start. Record the intention to make a determination in the database and go to paragraph 8. If the area has been determined in the last five years advise the pharmaceutical services regulations committee that it will first need to satisfy itself that there has been a substantial change in circumstances in relation to that area since the determination was made. Record the intention to make a determination in the database and go to paragraph 3. 3. Where the pharmaceutical services regulations committee must first be satisfied that there has been a substantial change in circumstances, gather relevant information on the area. This may involve a site visit. If it does, ensure sufficient information on the area is gathered to answer both this issue and also to assist if a determination is subsequently to be made (see paragraph 9 below). Complete Rurality01 committee report 1 and send to the committee administrator/secretary. 4. If the pharmaceutical services regulations committee determines that there has been no substantial change in circumstances send Rurality01 annex 2 to the committee (LMC or LPC) that made the request. 5. Diarise the latest date for appeals to be made. 6. If notice of an appeal is received advise the pharmaceutical services regulations committee and assist in the production of a response. 7. If the FHSAU determines that there has been no substantial change in circumstances update the controlled localities database accordingly. There are no further actions under this procedure note. If the FHSAU determines that there has been a substantial change in circumstances move to the next paragraph. 8. Where no determination has been made in the last five years or if the pharmaceutical services regulations committee or the FHSAU determines that there has been a substantial change in circumstances, the process of making the determination may begin. Send Rurality01 annex 3 to interested parties notifying of the intention to Status: Approved Next Review Date: June 2014 Page 9 of 17

make a controlled locality determination. Refer to the Policy for determining applications received for new or additional premises under the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 regarding the identification of interested parties. 9. During the 30-day notification period identify any dispensing patients living in the area that is to be determined. Arrange a site visit and gather information on the area. Following the site visit prepare Rurality01 committee report 2, which includes the findings of the site visit and any representations that have been received, for the pharmaceutical services regulations committee and send to the committee administrator/secretary. 10. After the meeting prepare the relevant decision letters (Rurality01 annexes 4-6) based on the minutes of the pharmaceutical services regulations committee meeting and send to the officer responsible for signing decision letters for signing. Once the decision letters are signed distribute to the interested parties. 11. Diarise the latest date for appeals to be made. 12. If notice of an appeal is received advise the pharmaceutical services regulations committee and assist in producing a response. 13. If the pharmaceutical services regulations committee or, on appeal, the FHSAU determines that the area is a controlled locality, or is part of a controlled locality, the boundary must be precisely delineated on a map and this map must then be published. Ensure that the map is of sufficient size to enable identification of a single dwelling as being either in a controlled or an uncontrolled, locality. Maps are to be produced and stored in an electronic format for ease of distribution, retrieval and editing. The map must be sent to the Health and Well-being Board (HWB) that has all or part of that controlled locality in its area within five working days. Update the controlled locality determinations database. There are no further actions regarding this procedure note. If the pharmaceutical services regulations committee or, on appeal, the FHSAU determines that the area is no longer a controlled locality, or is no longer part of a controlled locality, update and publish the relevant controlled locality map and update the Controlled locality determinations database. Advise the HWB that has all or part of the area that is no longer a controlled locality in its area within 5 working days. If the pharmaceutical services regulations committee or, on appeal, the Status: Approved Next Review Date: June 2014 Page 10 of 17

FHSAU determines that the area is not a controlled locality, or is not part of a controlled locality, update and publish the relevant controlled locality map if necessary and update the controlled locality determinations database. Advise the HWB that has all or part of the area that is no longer a controlled locality in its area within five working days. 14. If there are dispensing patients living in the area that has been determined not to be a controlled locality, record the date on which they must be removed from dispensing lists (having regard to the gradualisation decision, including any appeal relating to this). If gradualisation has been given prepare lists of dispensing patients by practice within 1.6km of the pharmacy (ie those who will be removed from dispensing lists) and send Rurality 01 annex 7 to the relevant practices. Resolve any queries raised by practices, carrying out site visits if necessary. Send Rurality01 annex 8 to the affected patients as soon as the date for responses from the practices has passed or once any queries have been resolved. On the date of removal change the patients dispensing status on Exeter. There are no further actions to be completed regarding this procedure. Note the timescales above may need to be altered to reflect the actual period of gradualisation or if no gradualisation has been given. Monitoring and review of procedure 18 This procedure will be reviewed regularly, with frequency determined by NHS England. There are robust arrangements for the maintenance and storage of all records, minutes, and reports associated with the procedure to ensure a clear audit route through the procedures related to this policy. NHS England may instigate an internal audit, or be required to submit information to an external body for scrutiny. Annex 1: abbreviations and acronyms Status: Approved Next Review Date: June 2014 Page 11 of 17

A&E APHO APMS AT AUR BDA BMA CCG CD CDAO CGST CIC CMO COT CPAF CQC CQRS DAC Days DBS DDA DES DH EEA epact ESPLPS EU FHS FHS AU FHSS FPC FTA FTT GDP GDS GMC GMS accident and emergency Association of Public Health Observatories (now known as the Network of Public Health Observatories) Alternative Provider Medical Services area team (of NHS England) appliance use reviews British Dental Association British Medical Association clinical commissioning group controlled drug controlled drug accountable officer NHS Clinical Governance Support Team community interest company chief medical officer course of treatment community pharmacy assurance framework Care Quality Commission Calculating Quality Reporting Service (replacement for QMAS) dispensing appliance contractor calendar days unless working days is specifically stated Disclosure and Barring Service Disability Discrimination Act directed enhanced service Department of Health European Economic Area electronic prescribing analysis and costs essential small pharmacy local pharmaceutical services European Union family health services family health services appeals unit family health shared services family practitioner committee failed to attend first-tier tribunal general dental practitioner General Dental Services General Medical Council General Medical Services Status: Approved Next Review Date: June 2014 Page 12 of 17

GP general practitioner GPES GP Extraction Service GPhC General Pharmaceutical Council GSMP global sum monthly payment HR human resources HSE Health and Safety Executive HWB health and wellbeing board IC NHS Information Centre IELTS International English Language Testing System KPIs key performance indicators LA local authority LDC local dental committee LETB local education and training board LIN local intelligence network LLP limited liability partnership LMC local medical committee LOC local optical committee LPC local pharmaceutical committee LPN local professional network LPS local pharmaceutical services LRC local representative committee MDO medical defence organisation MHRA Medicines and Healthcare Products Regulatory Agency MIS management information system MPIG minimum practice income guarantee MUR medicines use review and prescription intervention services NACV negotiated annual contract value NCAS National Clinical Assessment Service NDRI National Duplicate Registration Initiative NHAIS National Health Authority Information System (also known as Exeter) NHS Act National Health Service Act 2006 NHS BSA NHS Business Services Authority NHS CB NHS Commissioning Board (NHS England) NHS CfH NHS Connecting for Health NHS DS NHS Dental Services NHS LA NHS Litigation Authority NMS new medicine service NPE net pensionable earnings NPSA National Patient Safety Agency Status: Approved Next Review Date: June 2014 Page 13 of 17

OJEU OMP ONS OOH PAF PALS PAM PCC PCT PDS PDS NBO PGD PHE PLDP PMC PMS PNA POL PPD PSG PSNC QOF RCGP RO SEO SFE SI SMART SOA SOP SPMS SUI UDA UOA Official Journal of the European Union ophthalmic medical practitioner Office of National Statistics out of hours postcode address file patient advice and liaison service professions allied to medicine Primary Care Commissioning primary care trust personal dental services Personal Demographic Service National Back Office patient group direction Public Health England performers list decision panel primary medical contract Personal Medical Services pharmaceutical needs assessment payments online prescription pricing division (part of NHS BSA) performance screening group Pharmaceutical Services Negotiating Committee quality and outcomes framework Royal College of General Practitioners responsible officer social enterprise organisation statement of financial entitlements statutory instrument specific, measurable, achievable, realistic, timely super output area standard operating procedure Specialist Personal Medical Services serious untoward incident unit of dental activity unit of orthodontic activity Status: Approved Next Review Date: June 2014 Page 14 of 17

Annexes 2 to 8 Please see separate documents. Status: Approved Next Review Date: June 2014 Page 15 of 17

Version control tracker Version Number Date Author Title Status Comment/Reason for Issue/Approving Body 01.00 April 2013 Primary Care Commissioning Approved New document 01.01 June 2013 Primary Care Commissioning Approved Reformatted into NHS England standard Status: Approved Next Review Date: June 2014 Page 16 of 17

NHS England 2013 First published June 2013 Published in electronic format only. Status: Approved Next Review Date: June 2014 Page 17 of 17