Additional procedure for routine applications in a controlled locality (Rurality02)

Additional procedure for routine applications in a controlled locality (Rurality02)

Additional procedure for routine applications in a controlled locality (Rurality02) Standard operating policies and procedures for primary care Issue Date: June 2013 Document Number: OPS_2030 Prepared by: Primary Care Commissioning Status: Approved Next Review Date: June 2014 Page 2 of 20

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 Additional procedure for routine applications in a controlled locality (Rurality02 Publication Date June 2013 Target Audience Additional Circulation List Description Cross Reference Superseded Document Action Required Timing/Deadlines Author All NHS England Employees n/a Additional procedure for routine applications in a controlled locality (Rurality02) 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 20

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 20

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 on receipt of a routine application 8 Procedure after grant 13 Monitoring and review of procedure 14 Annex 1: Abbreviations and acronyms 15 Annexes 2 to 22 18 Version control 19 Status: Approved Next Review Date: June 2014 Page 5 of 20

Purpose of procedure 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. 1 Securing excellence in commissioning primary care http://bit.ly/mjwrfa Status: Approved Next Review Date: June 2014 Page 6 of 20

8 This suite of documents will be refined in light of feedback from users. 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 The procedures for relevant applications Procedure aims and objectives 10 The purpose of this procedure is to ensure that NHS England takes into account the additional requirements for certain routine applications set out in Part 7 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. 11 It is to be used together with all routine applications from pharmacies where the address or best estimate is, or may be, in a controlled locality. It does not apply to any excepted application. Neither does it apply to applications from dispensing appliance contractors. 12 It should be read together with the relevant market entry procedure. Background 13 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. 14 It may also be necessary to determine whether the area in which the pharmacy is to be located within a 1.6km radius of its premises or the AT s best estimate of where the premises will be located is to be a reserved location or not. A reserved location can be determined where the total number of people who are registered with a GP practice is less than 2,750 (temporary residents are not included in this total). 15 Where a routine application is received and the premises or best estimate are in a controlled locality, the pharmaceutical services regulations committee will need to consider the test of prejudice and also whether the application is in a reserved location. 16 There may be occasions where a routine application is received and it is Status: Approved Next Review Date: June 2014 Page 7 of 20

not clear from the AT s records whether it is in a controlled locality or not. In this instance the pharmaceutical services regulations committee may decide to make a controlled locality determination before determining the routine application. Scope of the procedure 17 This procedure applies to routine applications by pharmacy contractors for inclusion in NHS England s pharmaceutical list. Procedure on receipt of a routine application 18 The following steps should be undertaken at the same time as paragraphs 1 to 3 of the relevant market entry procedure i.e. while you are checking it is a valid application. 1. On the day the application is received check whether the premises or best estimate included in the application are in an area that has been determined to be, or could be, a controlled locality. If they definitely are not, follow the relevant market entry procedure and go no further with this procedure. If they are, or could be, move to paragraph 2. Note that where it is not known whether the area is a controlled locality or not, this matter will need to be determined before a decision is made on the application. 2. On the day the application is received, calculate the total GP registered population within a 1.6 km radius of the proposed premises or best estimate. If the radius extends to an adjoining noncontrolled locality, patients in this area should be included. Temporary residents should not be included. Identify any GP practices that have dispensing patients within 1.6 km of the proposed premises or best estimate and the number of such patients. 3. On completion of all the checks in paragraph 3 of the relevant market entry procedure, liaise with the officer dealing with the fitness to practise checks to ensure the application can be processed. Status: Approved Next Review Date: June 2014 Page 8 of 20

If the application can be processed and the premises/best estimate may be in a controlled locality, move to paragraph 4. If the application can be processed and the premises/best estimate are within a controlled locality, check the applications database to see if regulation 40(2) is relevant. If it is send Rurality02 annex 2 to the applicant and move to paragraph 13 below. If regulation 40(2) isn t relevant send Rurality02 annex 3 and move to paragraph 4 of the relevant market entry procedure. When notifying the application under paragraph 5 of the relevant market entry procedure, use the text in Rurality02 annex 10 in order that representations are sought on all the matters that are to be considered. Once the application is determined come back to this procedure at paragraph 16 below. If the application cannot be processed at this point, hold until it can be. If it is to be treated as withdrawn there are no further actions to be taken regarding this procedure. 4. Pass the application to the pharmaceutical services regulations committee for a decision as to whether a controlled locality determination is to be made, the area that is to be determined and whether the application should be deferred under regulation 38(4). If no determination of rurality is to be made ie the pharmaceutical services regulations committee is satisfied the premises/best estimate are not in a controlled locality, follow the relevant market entry procedure from paragraph 4 and go no further with this one. If a determination of rurality is to be made, send Rurality02 annex 4 to the interested parties and the applicant. If the committee determines that the application is to be deferred include the additional wording in the letter to the applicant. 5. Arrange a site visit and gather information on the area. Following the site visit prepare Rurality02 committee report 1, which includes the findings of the site visit and any representations that have been Status: Approved Next Review Date: June 2014 Page 9 of 20

received, for the pharmaceutical services regulations committee and send to the committee administrator/secretary. 6. After the meeting prepare the relevant decision letters (Rurality02 annexes 5 to 7), 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 applicant and interested parties. 7. Diarise the latest date for appeals to be made. 8. If no appeal is made and the pharmaceutical services regulations committee determined that the area is a controlled locality delineate the boundary on a map and publish it. Ensure 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. Send a copy of the map to any Health and Well-being Board (HWB) that has all or part of the controlled locality in its area. Check the applications database to see if regulation 40(2) is relevant. If it is, send Rurality02 annex 8 to the applicant and move to paragraph 13 below. If regulation 40(2) isn t relevant, send Rurality02 annex 9 to the applicant. Move to paragraph 4 of the relevant market entry procedure. When notifying the application under paragraph 5 of the relevant market entry procedure, use the text in Rurality02 annex 10 so that representations are sought on all the matters that are to be considered. Once the application is determined come back to this procedure at paragraph 16 below. 9. If no appeal is made and the pharmaceutical services regulations committee determined that the area is not a controlled locality, send Rurality02 annex 11 to the applicant and ensure the relevant map is updated to reflect any change in status. Advise any HWB that had all or part of that controlled locality in its area. If there are no dispensing patients living in the area follow the relevant market entry procedure from paragraph 4 and go no further with this one. Status: Approved Next Review Date: June 2014 Page 10 of 20

If there are dispensing patients living in the area and gradualisation was given, follow the relevant market entry procedure from paragraph 4 and complete the following actions. 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 02 annex 12 to the relevant practices. Resolve any queries raised by practices, carrying out site visits if necessary. Send Rurality02 annex 13 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. 10. If notice of an appeal is received advise the pharmaceutical services regulations committee and assist in producing a response. 11. If the NHS Litigation Authority determines that the area is not a controlled locality, send Rurality02 annex 14 to the applicant. If the area used to be a controlled locality ensure the relevant map is updated to reflect the change in status. Advise any HWB that had all or part of that controlled locality in its area. Follow the relevant market entry procedure from paragraph 4 and if no gradualisation has been given go no further with this one. If gradualisation has been given prepare lists of dispensing patients by practice within 1.6 km of the pharmacy (i.e. those who will be removed from dispensing lists) and send Rurality02 annex 15 to the relevant practices. Resolve any queries raised by practices, carrying out site visits if necessary. Send Rurality02 annex 13 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. Status: Approved Next Review Date: June 2014 Page 11 of 20

There are no further actions to be completed in respect of this procedure. 12. If the NHS Litigation Authority determines that the area is a controlled locality, delineate the boundary precisely on a map and publish it. 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. Send a copy of the map to any HWB that has all or part of the controlled locality in its area. Check the applications database and if regulation 40(2) is relevant send Rurality02 annex 16 to the applicant and move to paragraph 17 below. If regulation 40(2) is not relevant send Rurality02 annex 17 to the applicant and move to paragraph 4 of the relevant market entry procedure. When notifying the application under paragraph 5 of the relevant market entry procedure, use the text in Rurality02 annex 10 in order that representations are sought on all the matters that are to be considered. Once the application is determined come back to this procedure at paragraph 16 below. 13. Once the date for the applicant to submit any representations on regulation 40(2) has passed, send a copy of the application to the pharmaceutical services regulations committee for a decision as to whether the application must be refused by virtue of that regulation. 14. If the pharmaceutical services regulations committee determines that the application is to be refused by virtue of regulation 40(2) send Rurality02 annex 18 to the applicant. Diarise the latest date for an appeal to be made. If notice of an appeal is received advise the pharmaceutical services regulations committee and assist in the production of a response. If there are no appeals, the application has been refused. Update Status: Approved Next Review Date: June 2014 Page 12 of 20

the applications database to reflect the outcome. There are no further actions to be completed regarding this procedure. If the pharmaceutical services regulations committee s decision is overturned on appeal, send Rurality02 annex 19 to the applicant and move to paragraph 4 of the relevant market entry procedure. When notifying the application under paragraph 5 of the relevant market entry procedure, use the text in Rurality02 annex 10 so that representations are sought on all the matters that are to be considered. Once the application is determined come back to this procedure at paragraph 16 below. If the pharmaceutical services regulations committee s decision is upheld on appeal i.e. the application is refused, update the applications database. There are no further actions to be completed regarding this procedure. 15. If the pharmaceutical services regulations committee determines that there are no grounds to refuse the application by virtue of regulation 40(2) send Rurality02 annex 20 to the applicant and move to paragraph 4 of the relevant market entry procedure. When notifying the application under paragraph 5 of the relevant market entry procedure, use the text in Rurality02 annex 10 in order that representations are sought on all the matters that are to be considered. Once the application is determined come back to this procedure at paragraph 16 below. Procedure after grant 19 16. If the application is refused either by NHS England or on appeal update the applications database. There are no further actions to be completed regarding this procedure. 17. If the application is granted, either by NHS England or on appeal, and a reserved location was determined, if the pharmacy subsequently opens the boundary of that reserved location must be precisely delineated on the relevant controlled locality map. Ensure that the map is of sufficient size to enable identification of a single dwelling as being either within or outside the reserved location. Status: Approved Next Review Date: June 2014 Page 13 of 20

Send a copy of that map to the relevant HWB. There are no further actions to be completed regarding this procedure. If the pharmacy doesn t subsequently open there are no further actions to be completed regarding this procedure. 18. If the application is granted, either by NHS England or on appeal, and a reserved location was not determined, record the date on which patients living within 1.6 km of the pharmacy must be removed from dispensing lists (having regard to the gradualisation decision, including any appeal relating to this) and carry out the following actions: When the notice of commencement is received, prepare lists of dispensing patients by practice within 1.6 km of the pharmacy (i.e. those who will be removed from dispensing lists) and send Rurality02 annex 21 to GP practices with dispensing patients within 1.6km of the pharmacy. Resolve any queries raised by practices on those lists. Carry out site visits if necessary. Send Rurality02 annex 22 to the affected patients as soon as the date for responses from the practice 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. Monitoring and review of procedure 20 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 procedure for each contractor. NHS England may instigate an internal audit, or be required to submit information to an external body for scrutiny. Status: Approved Next Review Date: June 2014 Page 14 of 20

Annex 1: abbreviations and acronyms 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 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 Status: Approved Next Review Date: June 2014 Page 15 of 20

GMC General Medical Council GMS General Medical Services 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 Status: Approved Next Review Date: June 2014 Page 16 of 20

NPE NPSA 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 net pensionable earnings National Patient Safety Agency 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 17 of 20

Annexes 2 to 22 Please see separate documents. Status: Approved Next Review Date: June 2014 Page 18 of 20

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 to NHS England standard Status: Approved Next Review Date: June 2014 Page 19 of 20

NHS England 2013 First published June 2013 Published in electronic format only. Status: Approved Next Review Date: June 2014 Page 20 of 20