1. Service background

1.1 Cardiovascular disease (CVD) is one of the leading causes of premature death in England and accounts for 1.6 million disability-adjusted life years. Hypertension is the biggest risk factor for CVD and is one of the top five risk factors for all premature death and disability in England. An estimated 5.5 million people have undiagnosed hypertension across the country.

1.2 Early detection of hypertension is vital and there is evidence that community pharmacy has a key role in detection and subsequent treatment of hypertension and CVD, improving outcomes and reducing the burden on general practices (GPs). Cardiovascular disease prevention remains a high priority with a renewed commitment to focus on community-led methods to tackle variation in uptake of high-impact cardiovascular disease interventions in the 10 Year Health Plan for England. Community pharmacy is well placed to support this through the Hypertension Case-Finding Service. As community pharmacists increasingly become able to independently prescribe, the 10 Year Health Plan highlights an opportunity to increase their role in the management of long-term conditions, including the management of high blood pressure.

1.3 National Institute for Health and Care Excellence (NICE) guideline NG136 sets out the criteria that should be used for the diagnosis and management of hypertension in adults. It specifies that ambulatory blood pressure monitoring (ABPM) is the clinically preferred method for diagnosing hypertension. Home blood pressure monitoring (HBPM) is only an acceptable alternative if ABPM is unsuitable or where the patient cannot tolerate ABPM. HBPM may also be used for ongoing monitoring for those patients who have a prior diagnosis of hypertension.

2. Service objectives

2.1 The objectives of this service are to:

• Identify people aged 40 years or older – or, in certain specified exceptional circumstances (see below) and at the discretion of pharmacy staff, people under the age of 40 – with high blood pressure (who have previously not had a confirmed diagnosis of hypertension), and to refer them to general practice to confirm diagnosis and for appropriate management.
• Following signposting of a patient from their general practice, undertake clinic blood pressure measurements for adults who are aged 40 years and over, without a prior diagnosis of hypertension and who have not had their blood pressure checked in the last 5 years (see section 4.2).
• Offer ambulatory blood pressure checks to adults who are aged 40 years and over at the request of other healthcare professionals such as general practices, optometrists and dentists (generally following clinic checks done at other healthcare settings).
• Promote healthy behaviours to patients.

3. Requirements for service provision

3.1 The service commencement date for service enhancements contained within this specification will be announced and authorised by NHS England.

3.2 Prior to provision of the service, the pharmacy contractor must:

• be satisfactorily complying with their obligations under Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations (Terms of Service of NHS pharmacists) in respect of the provision of Essential services and an acceptable system of clinical governance.
• notify NHS England that they intend to provide the service by completion of an electronic registration declaration through the NHS Business Services Authority’s (NHSBSA) Manage Your Service (MYS) portal.
• engage with local general practices and, or primary care network colleagues to make them aware the pharmacy is participating in this service.

3.3 The pharmacy contractor must seek to make the service available throughout the pharmacy’s full opening hours (i.e. core and supplementary).

3.4 Distance selling pharmacies may ONLY claim for the service where it has been delivered off-site. Permission for off-site provision must be sought from their respective integrated care board (ICB) (see Annex F).

3.5 The pharmacy contractor must ensure the service is accessible, appropriate and sensitive to the needs of all patients. No eligible patient should be excluded or experience difficulty in accessing and effectively using this service due to their race, gender, disability, sexual orientation, religion or belief, gender reassignment, marriage or civil partnership status, pregnancy or maternity, or age.

3.6 The service should be provided by suitably trained and competent pharmacy staff. The responsible pharmacist must ensure that delegated tasks are being undertaken safely by competent pharmacy staff. The pharmacy contractor must ensure all pharmacy staff providing the service are appropriately trained. Pharmacy staff providing the service must:

• Have read and understood the operational processes to provide the service as described in this service specification.
• Be familiar with the parts of NICE Guideline (NG136) Hypertension in adults diagnosis and management relevant to the role they are undertaking within the service.
• Complete training (e-learning or face-to-face) on how to use the blood pressure monitoring equipment which should be provided by the equipment manufacturer.

3.7 Pharmacies (with the exception of DSPs- see Annex F) must have a consultation room that will be used for the provision of the service which meets the requirements in the terms of service. The consultation room should also comply with the following requirements:

• When measuring blood pressure, the patient must be able to rest their arm on a table or bench at a suitable height.
• Must have IT equipment accessible within the consultation room to allow contemporaneous records of the consultations provided as part of this service to be made within the NHS IT system.

3.8 The service will usually be provided on the pharmacy premises, but patients can also be identified, and the service provided in other locations outside the pharmacy, such as areas not designated part of the pharmacy within supermarkets or large stores or in community locations, with agreement from the ICB. This may include, but is not limited to:

• community centres
• sports grounds
• places of worship

3.9 Where the service is provided from premises other than the registered pharmacy premises, this can only be undertaken with the prior consent of the ICB. Pharmacy contractors must seek approval by submitting a request for approval to the ICB using the request form set out in Annex F. The requirements which pharmacy contractors must meet when making such an application and further information on the approval process are detailed in Annex F.

3.10 Provision from premises other than the registered pharmacy premises must only be for occasional provision; ICBs can give consent to a pharmacy contractor for up to four days of provision from offsite locations each financial year.

3.11 Pharmacy contractors must ensure the location is appropriate for service provision (i.e. meets standards required by the General Pharmaceutical Council and that patient confidentiality can be maintained). A risk assessment for the proposed location must be undertaken to identify and minimise risks to patient safety and the impact on wider pharmacy services. A copy of the risk assessment must be provided to the ICB as part of the approval request.

3.12 The responsible pharmacist at the registered pharmacy premises is professionally responsible for overseeing this advanced service. If the responsible pharmacist is unable to provide sufficient oversight, for example due to workload or where the service is undertaken off the pharmacy premises, an on-site pharmacist or pharmacy technician responsible for the delivery of the service must be linked and work closely with the Responsible Pharmacist and Superintendent Pharmacist through an appropriate written governance framework to ensure appropriate oversight of the service.  

3.13 The pharmacy contractor must ensure they have both a blood pressure monitor and an ABPM device. Equipment that is to be used in the service must be validated by the British and Irish Hypertension Society (BIHS). The clinic blood pressure monitor and ABPM devices used must be listed on the BIHS approved monitor list on the BIHS website.

3.14 Validation, maintenance and recalibration of all blood pressure monitors should be carried out periodically according to manufacturers’ instructions.

3.15 Infection control measures and cleaning must be carried out on all blood pressure monitors as per the instructions of the manufacturer or supplier and in line with current infection prevention and control guidance.

3.16 An NHS IT system which meets the minimum digital requirements of the service (as specified within the Community Pharmacy Clinical Services Capabilities and Standards and including an application programming interface (API) to facilitate transfer of data into the NHSBSA’s MYS portal) must be used by pharmacy contractors.

3.17 The pharmacy contractor must have a standard operating procedure (SOP) in place covering the provision of the service, which must include the process for escalation of any non-clinical issues identified, signposting details, record keeping, equipment maintenance and validation, and staff training. This should be reviewed regularly and following any significant incident or change to the service. The pharmacy contractor must ensure that all pharmacy staff involved in the provision of the service are familiar with and adhere to the SOP.

3.18 The pharmacy contractor is required to report any patient safety incidents in line with the clinical governance approved particulars for pharmacies.

4. Service description

4.1 Flow charts illustrating the full-service pathway can be found in Annexes A, B, C and D.

Inclusion criteria

4.2 For the service to be a success, potential patients who meet the opportunistic inclusion criteria should be proactively identified.

The inclusion criteria for opportunistic blood pressure checks are as follows:

• Adults who are 40 years old or over, who do not have a current diagnosis of hypertension.
• Patients, by exception, under the age of 40 who do not have a current diagnosis of hypertension, but who request the service because they have a family history of hypertension or who are at increased risk of developing hypertension (South Asian and African-Caribbean populations) may receive the service at the discretion of pharmacy staff. Contemporaneous notes of the reason for inclusion should be made in the clinical record where discretion is applied.
• Exceptionally, patients between 35 and 39 years old who do not have a current diagnosis of hypertension, but who are approached by pharmacy staff about the service may be tested at the discretion of the pharmacy staff. Contemporaneous notes of the reason for inclusion should be made in the clinical record where discretion is applied.

The inclusion criteria for patients signposted from their general practice or other healthcare settings are as follows:

• Adults aged 40 years and over without a prior diagnosis of hypertension who have not had their blood pressure checked in the last 5 years signposted by their general practice or other healthcare setting for clinic checks.
• Adults aged 40 years and over who have had an initial clinic blood pressure check at another healthcare setting and are signposted for ABPM (e.g. by general practices, optometrists and dentists).
• The process for signposting should be agreed locally with general practices and any other healthcare settings that are signposting. If general practices or other healthcare settings are signposting people who are not eligible to receive the service, this should be fed back to them.

Exclusion criteria

4.3 The exclusion criteria for all aspects of the service are as follows:

• People under the age of 40 years, unless under exceptional circumstances and at the discretion of the pharmacy staff. Contemporaneous notes of the reason for inclusion should be made in the clinical record where discretion is applied (e.g. family history or high risk of CVD).
• People who have had their blood pressure checked at the pharmacy via this service in the last five years. In exceptional clinical cases, as described in 4.12, one repeat blood pressure check may be warranted within a five-year period. Contemporaneous notes of the reason for inclusion should be made in the clinical record where discretion is applied.
• People who have their blood pressure regularly monitored by a healthcare professional including:
• People who require daily blood pressure monitoring for any period of time, e.g. 7-day clinic BP checks as an alternative to ABPM.
• Patients who seek a blood pressure check, but who are already being treated for hypertension.
• Any patient who is identified as suitable to be included under the criteria but where the smallest/largest cuff available does not fit and therefore, an accurate blood pressure cannot be obtained, should be directed to their GP.

Consultation with the patient

4.5 Prior to undertaking a clinic check, the service should be explained to the patient, including the possibility of them being offered ABPM, and their consent should be gained for the clinic check.

4.6 The pharmacy staff should then conduct a face-to-face consultation in the pharmacy consultation room (or other suitable location, if the service is provided outside of the pharmacy and this has been authorised by the ICB) and will take blood pressure measurements following best practice as described in NICE guidance (NG136) Hypertension in adults: diagnosis and management.

4.7 The pharmacy staff should discuss the results with the patient and complete the appropriate next steps (see Annex E). As part of the consultation, the patient should be provided with the details of their blood pressure results.

4.8 All blood pressure checks should be carried out with due consideration for the patient’s overall health. For example, if the patient has a clinic check and their blood pressure is in the normal range but they report other related symptoms, consider the use of National Early Warning Score (NEWS) 2 to determine the global clinical impression of the patient. Where required, patients may need referral to another healthcare provider.

4.9 Where pulse rate is recorded as part of the BP check, the pharmacy staff should consider referring the patient to their general practice if a pulse rate below 50 beats per minute (bpm) or greater than 115 bpm is noted, even if their blood pressure is normal.

Test outcomes

4.10 All test results must be sent to the patient’s general practice. Some test results indicate urgent escalation is needed (see details below) and in these cases the pharmacy staff should telephone the patient’s general practice and send their blood pressure test results immediately via an NHS IT system. Once an initial clinic blood pressure reading has been taken, there are several possible outcomes and actions required from the pharmacy staff. These are set out in Annex E.

4.11 A high systolic and normal diastolic reading OR a high diastolic and normal systolic reading should be recorded as a high blood pressure reading. Appropriate action should be taken if either the systolic or the diastolic measurement, or both fall outside the normal range.

4.12 In line with NICE guideline NG136, if hypertension is not evident, clinic blood pressure should be measured at least every five years and healthcare professionals should consider measuring it more frequently if blood pressure is close to 140/90mmHg, if blood pressure is lower than 90/60mmHg, or the patient has previously been diagnosed with diabetes.

4.13 For the purposes of this service, pharmacy contractors are ordinarily only allowed to claim for one clinic check per eligible patient (i.e. in line with the inclusion criteria) once in five years. Repeat blood pressure checks are out of scope of the Hypertension Case-Finding Service. In exceptional clinical cases (as described in 4.12), one repeat blood pressure check may be warranted within a five-year period. Justification of the repeat check must be recorded in the clinical record and be available at the premises for post-payment verification (PPV) purposes.

Promoting healthy behaviours

4.14 After the initial clinic blood pressure testing is complete, information should be provided about the blood pressure reading, including what the numbers mean. For example, resources from Blood Pressure UK or a patient leaflet to support provision of readings may be downloaded from the Community Pharmacy England website and shared with the patient.

4.15 There should be a brief discussion about the patient’s current lifestyle/behaviour as described in NICE Guideline (NG136) Hypertension in adults: diagnosis and management, with relevant advice provided on improving behaviours and reducing risk factors. This advice should be augmented with written information and/or links to online resources, and patients can also be signposted to relevant support services. A summary of the advice provided, and any signposting should be recorded in the clinical record for the service.

Ambulatory blood pressure monitoring (ABPM)

4.16 When loaning an ABPM device to the patient, pharmacy contractors may wish to ask patients to complete a blood pressure monitor loan form. They must reset the meter for each patient, ensuring only readings for that patient will be included when reviewing the measurements taken during ABPM. The pharmacy staff should fit the ABPM device, briefly describe how the machine works and explain that it cannot become wet and, therefore, baths and showers must be avoided during the monitoring period. Instructions should be provided on what to do when a reading is being recorded. The pharmacy staff should ensure that the monitor is set up to record two measurements per hour taken during the person’s usual waking hours (for example between 08:00 and 22:00).

4.17 The ABPM device will record all readings in its internal memory. Pharmacy staff must use the average value of at least 14 measurements taken during the person’s usual waking hours as the result of the monitoring. This average ABPM measurement, taken during usual waking hours, should be recorded in the consultation record and the average ABPM measurement, taken during waking hours and also the night time and total average readings should be sent on to the patient’s general practice via the NHS IT system. The ABPM transcript should also be shared with the GP Practice via email. The pharmacy staff should interpret and explain the result during the patient’s return appointment.

4.18 Although the average wake time ABPM is used to establish the blood pressure category every effort should be made to encourage patients to wear the ABPM device for as long as possible to obtain wake and sleep time readings. For example, fitting the device in the afternoon and removing it in the evening may not provide sufficient readings to inform any diagnosis, taking into consideration failed readings, duration of wear and a patient’s circadian rhythm. Those who are fitted with an ABPM in the afternoon should be encouraged to carry on into the next day to obtain the appropriate number of wake hours readings. This allows the diagnosing clinician to view how blood pressure changes over the day and night. If ABPM is unsuitable or the patient is unable to tolerate it, they should be referred to their general practice with appropriate documentation of this added to the clinical record.

4.19 Where patients have had an initial clinic blood pressure check at other healthcare settings and have been referred for ABPM, where provided, the clinic blood pressure reading undertaken at the other healthcare setting should be noted and documented, citing the setting where the initial clinic reading was taken and not in the pharmacy. A clinic blood pressure measurement should not be repeated in the pharmacy. If a clinic blood pressure reading has not been provided as part of the referral for an ABPM, this should be noted in the clinical record.

4.20 ABPM should be offered to patients in a timely manner where clinic blood pressure results are between 140/90mmHg and 180/120mmHg (this threshold also applies to patients who are aged 80 years and over). For example, either on the same day as the clinic reading where an ABPM device is available, as soon as convenient to the patient, or as soon as an ABPM device will become available. While this should ideally be within a few days of the initial clinic measurement, pharmacy contractors should ensure they have appropriate procedures in place to manage provision in any periods where an ABPM is not going to be available, e.g. more than one patient with high blood pressure has been identified in the course of a day or a week, during periods where the ABPM device is temporarily unavailable due to it being with another patient, or during periods of equipment calibration or repair. It would be expected that where the full service cannot be offered, that NHS Profile Manager would be used to remove the service offer from the pharmacy contractors’ profiles on the Directory of Services and on NHS.uk website.

4.21 The recorded data must be documented for each patient and in all cases, patients should be given a record of their average blood pressure results to show the GP where applicable and all results must be shared with the patient’s general practice via the NHS IT system.

4.22 The following next steps will apply depending on the average wake time ABPM results obtained:

i. Average wake time ABPM indicates a normal blood pressure

• Where ABPM shows an average wake time blood pressure of lower than 135/85mmHg and higher than 90/60mmHg.
• The patient should be given a record of their results and provided with advice on maintaining healthy behaviours, if not provided as part of the clinic check

ii. Average wake time ABPM indicates stage 1 hypertension

• Where ABPM shows an average wake time blood pressure of 135/85mmHg or higher but lower than 150/95mmHg.
• Patients should be asked to make contact with their general practice team and referred by the pharmacy to see their general practice via the NHS IT system within 3 weeks.

iii. Average wake time ABPM indicates stage 2 hypertension

• Where ABPM shows average wake time blood pressure of 150/95mmHg or higher but lower than 170/115mmHg.
• Patients should be asked to make contact with their general practice team and referred by the pharmacy to see a member of their general practice team via the NHS IT system within 7 days unless they also report symptoms such as labile or postural hypotension, headache, palpitations, pallor, abdominal pain or diaphoresis.
• Patients who report physical symptoms should be advised to see a medical professional sooner. During opening hours, the pharmacy staff must also call the general practice, while the patient is still in the pharmacy, to communicate the readings over the phone and via the NHS IT system or other secure digital process.
• Where pharmacy staff, other than the pharmacist, have provided the service, the responsible pharmacist should be made aware of any patients exhibiting physical symptoms before the patient leaves the pharmacy.

iv. Average wake time ABPM indicates severe hypertension (very high blood pressure)

• Where ABPM shows average wake time blood pressure of 170/115mmHg or higher.
• Patients must be urgently referred by the pharmacy and asked to contact their general practice on the same day.
• Patients should be asked about other symptoms and those with any acute symptoms such as headache, palpitations, new onset confusion, chest pain, signs of heart failure or acute kidney injury should be given a record of their results and urgently referred to their local A&E, via 999 where necessary.
• During opening hours, the pharmacy staff must call the general practice, while the patient is still in the pharmacy, to communicate the readings over the phone and via the NHS IT system or other secure digital process.
• Where pharmacy staff, other than the pharmacist, have provided the service, the responsible pharmacist must be made aware of the need for a same day referral to the patient’s general practice before it is made.
• If it is not possible to contact the general practice or the general practice is closed, the patient must be referred to other locally agreed urgent care providers for a same day appointment.

v. Average wake time ABPM indicates low blood pressure

• Where ABPM shows average wake blood pressure to be less than 90/60mmHg.
• Patients should be asked about other symptoms and a holistic approach should be applied at all times- refer to Annex E, and follow the appropriate action based on the patient’s reported symptoms.

4.23 Patient non-attendance for ABPM:

Collection of equipment for measurement of ABPM

• Should a patient fail to attend a scheduled pharmacy appointment as part of this service to be fitted with equipment for ABPM, the pharmacy contractor should make at least two attempts, on separate occasions, to contact the patient to rearrange the appointment within 7 days. In the event of a failure to attend, the patient’s general practice record should be updated with the relevant notification (section 4.10) and the general practice team should be notified, on or after the 7th day, of the failure to attend to be fitted with equipment for ABPM.

Receiving results and returning equipment

• Should a patient fail to attend a scheduled pharmacy appointment as part of this service to receive the results of ABPM and return equipment, the pharmacy staff will seek to contact the patient to rearrange the appointment.
• If, despite these attempts to make contact, the patient does not return to receive ABPM results within five working days after the agreed appointment date, the patient’s general practice record must be updated with the relevant notification (section 4.10), with actions for the general practice team to follow up with the patient.
• If no readings are recorded for any other reason i.e. the device was not tolerated, the patient’s general practice record must be updated with the relevant notification (section 4.10), with actions for the general practice team to follow up with the patient.

5. Data and information management

5.1 Before blood pressure measurements are taken, verbal consent must be sought from the patient and recorded in the pharmacy’s clinical record for the service. The patient should also be advised of the following information sharing that will take place:

• The sharing of information between the pharmacy and the patient’s general practice to allow the appropriate recording of the blood pressure reading in their general practice record.
• The sharing of information about the service with NHS England as part of service monitoring and evaluation.
• The sharing of information about the service with the NHSBSA and NHS England for the purpose of contract management and as part of post-payment verification.

5.2 The pharmacy contractor must maintain appropriate clinical records within the NHS IT system to ensure effective ongoing service delivery. Further information on the data that is collected and retained in the contractor’s clinical record as part of service delivery, including where this data is shared with other organisations, can be accessed vis the following links:

• Information shared with a GP following consultation Summary of GP Connect service – NHS England Digital
• Information shared with NHS Business Services Authority to support pharmacists being paid and to monitor the service they provide MYS – Pharmacy – NHSBSA

5.3 The pharmacy contractor must adhere to defined standards of record keeping, ensuring that the clinical record is made contemporaneously (in real time) during the consultation, unless exceptional circumstances apply. Where the NHS IT system is unavailable due to exceptional circumstances beyond the control of the pharmacy contractor, then the clinical record must be added to the system as soon as possible after it becomes available again. If the problem persists for a period greater than 3 working days, then the pharmacy contractor must notify the ICB of the issue.

5.4 Data from the NHS IT system will be submitted to the MYS portal via an API and will be used by the NHSBSA for payment and post-payment verification purposes. Some of this data, which has been anonymised, will be shared with NHS England for service evaluation and research purposes.

5.5 Records of service delivery relating to consultations where claims have been made via the NHSBSA’s MYS portal should be retained at the pharmacy premises and be available for PPV purposes for three years. These records must be provided by a pharmacy contractor when requested by the NHSBSA Provider Assurance Team.

5.6 The pharmacy contractor will ensure that a notification of the provision of the service is sent to the patient’s general practice on the day of provision or on the following working day. This will be sent as a structured message in real-time via the NHS IT system. In some case, a phone call to general practice or other appropriate healthcare setting may be required if an urgent referral is needed. If the structured message system is not available or fails, the pharmacy contractor must ensure a copy of the consultation record is sent or emailed (via NHS.net) to the individual’s general practice, and a record of this kept in the pharmacy for PPV purposes.

5.7 Accurate record keeping of service delivery to eligible patients in accordance with the service specification is an essential part of the service provision. This data informs the patient record held by GP systems and any errors could lead to the corruption of patients’ records.  

5.8 All relevant records must be managed in line with Records Management Code of Practice for Health and Social Care. As part of this requirement, pharmacy contractors should ensure that clinical records for the service are retained for the appropriate period. This retention period may be beyond the specified period for PPV purposes and should be in line with the requirements for the record type.

6. Payment arrangements 

6.1 Pharmacy contractors providing this service will be eligible for the payments detailed in the Drug Tariff determination.

6.2 Data to populate a payment claim for this service will automatically be added to the MYS portal using the API between the NHS IT system and the NHSBSA. Pharmacy contractors will need to submit the claim within the MYS portal, as part of the normal month end claims process.

6.3 Remuneration will be made on the condition that the pharmacy has provided the service in accordance with the service specification claims for payment should be submitted within one month of, and no later than three months from the claim period for the chargeable activity provided. Claims which relate to work completed more than three months after the claim period in question, will not be paid unless the submission of a claim was delayed by IT issues outside the pharmacy contractor’s control (such as issues with the NHS IT system used by the pharmacy contractor or with the MYS portal). Such claims will be accepted outside the usual grace period within twelve months of the date by which the claim should have been submitted. This is subject to the NHSBSA receiving evidence of the IT issue, and only if investigation finds that the evidence demonstrates that the IT issue was outside the control of the pharmacy contractor, and it delayed the claim submission.

6.4 If the pharmacy contractor is commissioned to deliver any related services, e.g. the NHS pharmacy contraception service (incorporating BP clinic measurement) as an advanced service within the community pharmacy contractual framework, the pharmacy contractor may not claim twice for the same activity.

6.5 When an initial clinic blood pressure check is undertaken at another healthcare setting (e.g. optometrists and dentists), only a claim for ABPM can be made.

7. Withdrawal from the service

7.1 If the pharmacy contractor wishes to stop providing the service, they must notify NHS England that they are no longer going to provide the service via the MYS portal, giving at least 30 days’ notice prior to cessation of the service. Pharmacy contractors may be asked for a reason as to why they wish to stop providing the service.

7.2 The pharmacy contractor must continue to provide the service for the duration of the notice period.

7.3 If the pharmacy contractor de-registers from the service, they will be unable to re-register for a period of four months from the date of de-registration.

7.4 If a pharmacy contractor de-registers from the service, and in the event that no money has been reclaimed, the pharmacy contractor will not be eligible for a further set up fee if they re-register at any later date.

8. Monitoring and post-payment verification

8.1 In addition to meeting the Essential services requirements, the pharmacy contractor shall ensure the pharmacy has the following and that these are available for inspection should the ICB undertake a site visit:

A working and appropriately calibrated blood pressure monitor and ABPM monitor (subject to current patient loan)

Post payment verification

8.2 NHS England has a duty to be assured that where pharmacy contractors make claims for payment for set up fees, or activity in services, that they meet all the specified requirements of the service. NHS England will work with the NHSBSA Provider Assurance Team to undertake Pre and Post-payment Verification (PPV) checks on claims made.

8.3 Reasonable additional evidence, related to eligibility of patients and the service delivery, may be requested directly from pharmacy contractors. The verification checks include comparing the information provided by pharmacy contractors in their claims against datasets and evidence sources that are available to the NHSBSA Provider Assurance Team.

8.4 It is the pharmacy contractor’s responsibility to be able to provide any reasonable evidence of service delivery to eligible patients in accordance with the service specification when requested by the NHSBSA for PPV. This includes offering clinic blood pressure and ambulatory checks where required. Therefore, pharmacy contractors must be able to demonstrate that they have enough ambulatory blood pressure monitors for anticipated demand. Commissioners will undertake ongoing monitoring and challenge provision of high numbers of clinic blood pressure checks that are eligible for ABPM with no, or low ABPM activity.

8.5 In cases where pharmacy contractors have been requested to provide evidence and it is not available or does not demonstrate that the service activity was delivered in accordance with the service specification, and so these claims cannot be verified, the pharmacy contractor will be informed. Where claims cannot be verified and the pharmacy contractor does not agree to the recovery of the associated payments, the case will be referred to the Pharmaceutical Services Regulations Committee (PSRC) to decide whether an overpayment has been made.

8.6 In cases where the PSRC decides that an overpayment has been made, and will need to be recovered, pharmacy contractors will be contacted by the NHSBSA and notified of the overpayment recovery process. In such cases, all payments that have been paid as a direct result of a claim that cannot be verified will be recovered. 

8.7 Any overpayment recovery would not prejudice any action that the NHS may also seek to take under the performance related sanctions and market exit powers within The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.

8.8 The necessary records specified in the service specification required for reimbursement must be kept for a period of three years to demonstrate service delivery in accordance with the service specification, and to assist with post-payment assurance activities. These records must be provided by a pharmacy contractor when requested by the NHSBSA Provider Assurance Team.

8.9 The data submitted informs the system used by the NHSBSA to make payments; any errors in the data could lead to claims not being paid or being recovered if they do not meet the service requirements.

Annex A: Blood pressure check process flowchart

Download a PDF of the above flowchart.

Annex B: Guidance on clinic blood pressure check

Download a PDF of the above flowchart.

Annex C: Clinic BP flowchart

Download a PDF of the above flowchart.

Annex D: ABPM flowchart

Download a PDF of the above flowchart.

Annex E: Summary table of action

Note: In all cases where a member of the pharmacy team, other than the pharmacist has provided the service, the responsible pharmacist should be made aware of the need for a same day referral to the patient’s general practice before it is made.

Annex F: Framework for ICB approval of off-site provision of the service

Introduction

This annex provides:

• guidance for pharmacy contractors, on the process for seeking permission from their ICB to provide the Hypertension Case-Finding Service at a location outside of the registered pharmacy premises (off-site); and
• a framework for use by Integrated Care Board (ICB) Commissioning Managers when they review and assess applications from pharmacy contractors to offer the service off-site.

The service specification permits the service to be provided for up to four days of provision per financial year in other locations outside the pharmacy, with prior agreement from the relevant ICB commissioning team.

DSPs not registered for the Hypertension Case-Finding Service may register to provide the service off-site, pending approval from the ICB commissioning team.

Off-site locations may have footfall from people who would not ordinarily access services from a pharmacy premises, bringing potential benefits to the individual and the NHS. However, approval for off-site provision may also be considered to be inequitable by other pharmacy contractors and could undermine the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (PLPS regulations) control of entry provisions.

This annex outlines principles for ICB commissioning team decision-makers to ensure that they comply with general duties, including to act fairly and reasonably, to not prefer one type of provider, and to exercise functions effectively.

2. General considerations for approval of off-site service delivery

The purpose of the service is case-finding people with undiagnosed hypertension, so they can be referred to their general practice to confirm the diagnosis and initiate treatment of the condition. As such, the ABPM element of the service is of critical importance, wherever the service is to be provided.

Providing the full service off-site may present practical challenges for pharmacy contractors, particularly in relation to provision of ABPM to suitable patients identified by off-site clinic checks when the off-site location will only be operating for up to four days per financial year.

Where the off-site location is close to the pharmacy premises, patients agreeing to ABPM may be able to return for their ABPM appointments at the pharmacy premises*. If the off-site location is a long distance from the pharmacy premises, this is less likely to be possible. Patients may not accept ABPM due to travel distance or practical challenges of returning the device. This will mean only part of the service will be provided. 

*Note: that would not be possible for distance selling premises pharmacies, as the service cannot be provided face-to-face on their premises

Unless previous provision of the service on the pharmacy premises is satisfactory, including an appropriate level of provision of ABPM, where high blood pressure is identified during the clinic check, ICB commissioning teams should carefully consider the ability of the pharmacy contractor to provide the full service at an alternative location prior to granting approval.

When offered at off-site locations, a consultation room is not required, provided the location is appropriate. The location should provide confidentiality for the patient, with them seated and able to rest their arm on a table/bench of a suitable height.

At the off-site location, the pharmacy contractor must ensure that an on-site pharmacist or pharmacy technician responsible for the delivery of the service must be linked and work closely with the Responsible Pharmacist and Superintendent Pharmacist through an appropriate governance framework to ensure appropriate oversight of the service. This also applies to DSPs.

Where the pharmacy contractor is proposing a clinic in an ICB area other than that of their pharmacy premises, the home ICB commissioning team of the pharmacy premises should liaise with the site ICB commissioning team prior to the home ICB commissioning team approving or declining the request for the off-site provision. This will enable more effective decision making, since neither commissioning team alone will have a complete picture as to whether the application is appropriate.

3. Information to be requested from pharmacy contractors seeking permission for off-site provision of the service

The following information or documentation should be requested from the pharmacy contractor prior to consideration of their request to provide the service off-site. A form is provided below that pharmacy contractors should complete and submit to their ICB.

• The dates and locations of the proposed off-site provision (up to 4 days per financial year).
• Confirmation they are currently providing the service in accordance with the service specification from their pharmacy premises (not DSPs).
• Confirmation that they are compliant with their obligations under Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations (Terms of Service of NHS pharmacists) in respect of the provision of Essential services and an acceptable system of clinical governance.
• Confirmation that they will be able to comply with the requirements of the service specification from the off-site location, in relation to:
  • Whether the service will be provided in a confidential area where the patient can be seated and rest their arm on a table/bench of a suitable height.
  • Whether the off-site location will have sufficient blood pressure monitors and ABPM devices available for use and that there will be procedures in place to ensure a timely offer and an appointment for ABPM will be offered to eligible patients if all of the ABPM devices are currently unavailable, due to use by other patients identified at the off-site location.
  • How very high blood pressure readings for those tested will be followed up on the day of those readings.
  • Record keeping at the off-site location using the pharmacy’s NHS IT system.
• Confirmation that they will provide the contact details for the pharmacy premises to all patients that receive the service, so they are able to contact the pharmacy with any further queries related to the service or complaints.
• Confirmation that they will have appropriate indemnity (e.g. clinical negligence and public liability) arrangements to cover off-site provision of the service.
• Confirmation that they have conducted a risk assessment of the proposed off-site location to identify and minimise risks related to health and safety, patient safety and the impact on wider pharmacy services that they offer at the pharmacy premises. A copy of the risk assessment must be provided to the ICB commissioning team before the application will be considered.
• Any additional information that the pharmacy contractor believes may be helpful to the ICB in reaching their decision, for example, that there are no other pharmacies nearby that are providing the service, that the off-site location will reach patients that may otherwise not access healthcare, or that the pharmacy contractor has received a request to offer a clinic to a specific underserved population.

4. ICB approval process

• The pharmacy contractor submits the form set out in Annex F to the ICB commissioning team for the pharmacy premises location (Home ICB) a minimum of two weeks before the commencement of the proposed off-site provision.
• The Home ICB considers the information submitted:
  • Whether the pharmacy contractor has answered the questions in an appropriate manner using the assessment criteria below.
  • Whether they believe the pharmacy contractor is, as far as known, compliant with the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations (Terms of Service of NHS pharmacists) in respect of the provision of Essential services and an acceptable system of clinical governance
  • For bricks-and-mortar pharmacies, whether they believe the pharmacy contractor is currently providing the service from their premises in full accordance with the service specification.
  • For distance selling pharmacies, whether they believe the pharmacy contractor has appropriate arrangements for ABPM follow up for patients with raised clinic blood pressure.
• The home ICB then liaises with the ICB commissioning team for the proposed clinic location (“Site ICB”) (where these are not the same).
• The Home ICB commissioning team should use the information submitted and the points considered above to make and record the decision, and then communicate it in writing to the pharmacy contractor.
• The Home ICB commissioning team should retain a record of the decision and any reasons for refusal.

Pharmacy contractor request form for off-site provision of Hypertension Case-Finding Service

This form is to be completed by the pharmacy contractor where they wish to seek approval from their ICB to offer the Hypertension Case-Finding Service in a location other than their pharmacy. It must be submitted to the ICB commissioning team at least two weeks before approval is needed, although in some cases this may be granted sooner.

Download a word version of the Pharmacy contractor request form for off-site provision of Hypertension Case-Finding Service

Annex G: Data recording and transfer

Please note that not all fields are mandatory.

Publication reference: PRN02194