1 Introduction

1.1 NHS England has 2 managed access funds, the Cancer Drugs Fund (CDF) and the Innovative Medicines Fund (IMF), referred to hereafter as ‘the managed access funds’ unless specific differences apply. Both funds will reimburse providers for the cost of drugs when used appropriately and in line with this standard operating procedure (SOP).

2 Purpose

2.1.  The aim of this document is to ensure that appropriate systems and procedures are in place so that providers are reimbursed for drug costs in a timely manner, where the use of the drug and the subsequent data submissions and communications adhere to the requirements set out below.

3 Audience

3.1. The primary audiences for this SOP are:

• NHS England, Medicines Value and Access Directorate
• NHS England national and regional contracting teams
• NHS providers

4 Roles and responsibilities

4.1 NHS providers

4.1.1 NHS providers, prescribing drugs funded by the managed access funds, will follow the below guidance when seeking reimbursement from NHS England.

4.1.2 NHS providers that require any clarification on any aspect of this SOP should reach out to their local Managed Access regional team or email cdfteam@nhs.net.

4.1.3 NHS providers that require any support in meeting the expectations of this SOP should reach out to their local Managed Access regional team or email cdfteam@nhs.net.

4.1.4 By using drugs funded via the managed access funds, NHS providers agree to the required actions as detailed in this SOP and any potential loss in funds if reimbursement is withheld through non-adherence.

A detailed list of provider responsibilities is included in Appendix B.

4.2 NHS England

4.2.1 NHS England, while reimbursing NHS providers for drugs funded through the managed access funds, will follow the below guidance and ensure providers are reimbursed in a timely manner.

4.2.2 The managed access funds will only cover the costs of medicines approved for use in the managed access funds.

5 Background

5.1 The CDF and IMF are managed access funds that enable patients to access promising new treatments while further evidence is collected to address clinical uncertainty identified as part of the National Institute for Health and Care Excellence’s (NICE) evaluation process. They also provide an interim funding route for drugs recommended by NICE for routine commissioning, giving patients access to treatments many months earlier than would otherwise be the case.

5.2 The managed access funds each have fixed budgets and expenditure control mechanisms (ECM) ensuring that if the fixed budget is fully allocated through either or both managed access funds, they can remain open to new treatments and patients.

5.3 For the managed access funds to function properly, providers are required to make high quality submissions to NHS England to enable reimbursement.

5.4 For more information on the managed access funds, see the Cancer Drugs Fund and Innovative Medicines Fund pages on the NHS England website.

6 Scope and applicability

6.1 This SOP applies to all aspects of provider reimbursement in managed access funds. The SOP should be the only reference point for this activity.

6.2 This SOP will be reviewed regularly to ensure the most efficient and clear mechanisms are in place for provider reimbursement.

6.3 Should providers have any questions around the SOP, all initial correspondence should go through their Managed Access regional team or via cdfteam@nhs.net.

7 Provider reimbursement procedures

7.1 Providers will be reimbursed for the cost of drugs prescribed to patients that have been approved for treatment through managed access fund budgets. Providers will only be reimbursed for:

• the cost of the drug at the point of prescription
• any VAT payable
• wastage of drug product (within Model Hospital guidelines)

7.2 The cost of the drug charged to NHS England must be at the cost-effective price approved by NICE as listed on the NHS England Commercial Access and Pricing (CAP) portal.

7.3 Delivery costs, on-costs (including the costs of aseptic preparation of drugs), homecare costs for dispensing or handling drugs and any other associated costs will not be reimbursed through the managed access funds budgets.

7.4 The cost of a drug will be eligible for reimbursement if:

• the drug/indication has been approved for funding from a managed access fund budget
• the patient has been approved as suitable following a submission through the online Managed Access prior approval system (currently Blueteq) (see 8.1); and
• complete and accurate data has been submitted via the Drugs Patient Level Contract Monitoring dataset (see 8.2)

7.5 To receive reimbursement providers must submit a monthly update of Drug Patient Level Contract Monitoring (DrPLCM) data to Arden and GEM CSU for all drug costs funded through the managed access funds. The commissioner code within the DrPLCM should distinguish between the CDF (Commissioned Service Category Code: 31) and IMF (Commissioned Service Category Code: 32) costs.

7.6 Accurate and complete data records for all DrPLCM ‘mandatory’ and ‘mandatory where relevant’ fields are fundamental for the validation of managed access charges. Providers must submit their year-to-date managed access funds DrPLCM data each month to the Data Landing portal. A list of fields required for validation within the DrPLCM are included in section 8.2.

7.7 The timelines for the data upload will be communicated to providers at the start of each financial year.

7.8 The Managed Access regional teams will approve requests for reimbursement of drugs following a number of validation checks. A non-exhaustive list is included in section 8.2.4. The validation checks are designed to ensure providers are using the drugs in line with NHS England’s clinical treatment criteria (Blueteq form). As such, these will often be drug and indication specific. A list of current clinical treatment criteria can be found via the CDF and IMF weblists (these can be found in the links in section 5.4).

7.9 Providers will be issued with 2 validation reports: 1 for standard challenges and 1 for price validation challenges. Further details on price validation requirements can be found in Appendix A. Providers must respond to challenges via the Managed Access regional teams and where appropriate make corrections to their DrPLCM data submission for the following month. Managed Access regional teams will identify corrections through monthly, year to date reconciliation and corrected challenges will be removed from future challenge reports.

7.10 Providers will be reimbursed separately for CDF and IMF activity using a block arrangement with monthly true-up payments used to align the total reimbursement amount with the activity of each provider.

7.11 A monthly payment on account will be based on a percentage of expected forecast expenditure for the year considering each provider’s historic data quality performance.

7.12 True-up payments will be paid to providers monthly, 1 month in arrears. Payment will be authorised for correct and accurate charges that have passed all validation checks and are not subject to challenge.

7.13 As an example, for M1:

1. Payment on account issued to provider.
2. M1 data submission.
3. Feedback provided in the challenge report.
4. Corrections submitted in M2.
5. True up paid following M2 submissions with corrected M1 data.

7.14 If the value of validated charges for a provider is below the value of the initial payment on account, NHS England will claw back any overpayments in line with the timeframes for true-up payments.

7.15 In addition, payment could be withheld if the provider is not compliant with the requirement to introduce e-prescribing or, for cancer drugs only, if the full SACT record applicable to the drug is not completed or made available in a timely way.

7.16 If it is found that a provider is consistently charging more than the prices agreed for drugs, the inconsistency will be investigated, and remedial interventions initiated as appropriate.

8 Information and reporting requirements

8.1 Prior approval submission

8.1.1 Every treatment funded through the managed access funds requires an approved prior approval form (currently submitted via Blueteq) for the indication being used to treat the patient. The form contains the clinical treatment criteria that must be met to be eligible for reimbursement.

8.1.2 Clinicians are required to complete prior approval forms accurately as they are part of the patient’s medical record and the information collected through them may be used to inform data collection to facilitate future NICE evaluations.

8.1.3 A prior approval form must be submitted within 2 days, or up to 30 days in advance, of the first administration of each treatment.

8.1.4 In exceptional circumstances, when a prior approval form could not be submitted in line with the above expectations, the circumstances will be reviewed by the managed access funds national teams. Providers should contact cdfteam@nhs.net in the first instance, with an outline of why a prior approval submission was not possible. A response with an outcome detailing whether a treatment can still be reimbursed, will be issued within 5 working days.

8.2 Drugs Patient Level Contract Monitoring Dataset (DrPLCM)

8.2.1 All DrPLCM submissions must adhere to the latest DrPLCM reporting requirements (see 10.3).

8.2.2 A number of fields are required for completion within the DrPLCM for validation. Completion of the following fields is mandatory:

• Financial Month
• Organisation Identifier (Code of Provider)
• Organisation Identifier (Code of Commissioner)
• Provider Reference Number
• Commissioned Service Category Code
• National Cancer Drugs Fund Form Code*
• NHS Number (required to match with prior approval notification system)
• Activity Treatment Function Code
• Clinical Intervention Date (Drug Dispensed)
• Therapeutic Indication Code
• High-Cost Tariff Excluded Drug Code (SNOMED CT DM+D)^
• Drug Name**
• Drug Strength**
• Drug Volume**
• Drug Pack Size**
• Drug Quantity or Weight Proportion
• Unit Price (Supplier)
• Commissioner Support Charge
• Value Added Tax Charged Indicator
• Total Cost
• Route of Administration (SNOMED CT DM+D)

*The 4-7-digit managed access fund form unique identifier must be used to populate the National Cancer Drugs Fund Form Code field in the patient level drug report for the CDF and IMF. For example, the character code PAN1 or CABO1, which is part of the title of the prior approval notification form used for that patient.

**Requirement of the Drug Name, Drug Strength, Drug Volume and Drug Pack Size fields are dependent on the taxonomy level of the High-Cost Tariff Excluded Drug Code.

8.2.3 Table 1 below shows the additional information that is required depending on the level of dm+d code provided.

Table 1 Data requirements by level of dm+d code

Please note that quantity is always required.

8.2.4 The DrPLCM datasets will be linked to information from the prior approval system to ensure providers are prescribing drugs in line with this SOP and the managed access validation process. A non-exhaustive list of validation checks that will be performed are outlined below:

• the costs charged are incorrect (the submitted price does not match the PAS price listed on the CAP portal – see 11.1)
• the patient has not been approved for treatment as a managed access fund patient via the prior approval notification system
• the drug was delivered more than 2 days prior to the approval of a prior approval form
• the drug was not delivered until more than 31 days after the approval of a prior approval form
• the drug is not funded by either of the managed access funds
• the drug was administered after the indication was no longer funded or moved from a managed access fund to a different commissioner (for example, routine commissioning)
• there was a gap in treatment that breached the NHS England treatment break policy, and a treatment break request has not been approved by NHS England (for CDF only)
• the provider has failed to complete mandatory fields on the DrPLCM

8.2.5 Providers will not be reimbursed for the cost of a drug where the information provided does not pass the validation process. Providers can request a full list of validation checks from their Managed Access Fund regional team.

9 Review timeline

9.1 This SOP will be reviewed every 12 months, or earlier if required. Updates will be communicated to all providers prior to the first DrPLCM submission for each financial year.

10 Associated documentation

10.1 Appraisal and Funding of Cancer Drugs from July 2016 (including the new Cancer Drugs Fund)

10.2 The Innovative Medicines Fund Principles

10.3 Directly commissioned services reporting requirements

10.4 Model Health System

11 Appendix A – Price challenge requirements

11.1 NHS England use validation checks (challenges) to confirm that providers are paying the correct price for managed access fund drugs (see 8.1.3).

11.2 The below DrPLCM fields will be used to perform the price challenge. These fields must be accurate and match the format and length as detailed in the DrPLCM specification:

• drug name
• strength
• volume* (for drugs which are administered in liquid form)
• pack size
• quantity*
• supplier unit price
• commissioner unit price (should be same as supplier unit price for CDF*)
• home delivery charge (should be 0 for CDF and IMF drugs)
• VAT charged* (this needs to be a Y or N)
• total cost
• clinical intervention date (drug dispensed)
• high-cost tariff excluded drug code (SNOMED CT DM+D)
• route of administration (SNOMED CT DM+D)
• national cancer drugs fund form code

* See NHS England drug taxonomy for additional clarification about data requirements.

11.3 For each charge to pass the validation, the data quality needs to be of a sufficient standard to accurately calculate what the expected price should be. Without this information, a price validation cannot be performed. Providers are encouraged to use dm+d codes (at VMPP or AMPP level) rather than completing data fields manually.

11.4 Providers will be reimbursed for the cost of the drug ingredient at the point of prescription and any VAT payable. If any delivery costs or on-costs are included in the total cost of the drug, the charge will be challenged.

11.5 If there is a data quality issue or the reported price is incorrect, the whole drug cost will be challenged.

11. 6 On occasions when the price of a drug changes, both the previous price and the new price, or any price in between, will be accepted to allow stock bought at the old price to be used. Current guidance encourages providers to reduce the length of time stock is held within hospitals. Therefore, providers may submit prices up to the old discounted price for 30 days after the price has been updated on the CAP portal.

11.7 Externally compounded products can be used for managed access fund indications, where the compounder uses the agreed PAS price for the drug costs. As outlined above, the managed access funds only pay for the drug costs and any dispensing fees must be separated out. This may mean providers have to ask their compounder for a breakdown of charges.

11.8 Where applicable, the CAP portal will include the approved price for all dose banded formulations available. Providers can use these prices to confirm the drug costs of any aseptic preparations.

11.9 NHS England will add a narrative to the price validation output that highlights why any charge has failed the price check, so providers are aware of the correction required.

12 Appendix B – Provider responsibilities

Information requirements

12.1 Providers acknowledge that the submission of complete and accurate data in accordance with this this SOP is necessary to support the commissioning of managed access funds in England.

12.2 The provider must:

12.2.1 provide the information specified in this SOP, and in the required information sources listed in this SOP, with the frequency, in the format, by the method and within the time period set out or referred to below; as detailed in relevant guidance; and, if there is no applicable time identified, in a timely manner

12.2.2 where and to the extent applicable, conform to all NHS information standards notices, data provision notices and information and data standards approved or published by the Secretary of State or NHS England

12.2.3 implement any other datasets and information requirements agreed from time to time between it and the Managed Access Team.

12.2.4 comply with Data Guidance issued by NHS England and with Data Protection Legislation in relation to protection of patient identifiable data.

12.2.5 subject to and in accordance with law and guidance and any relevant standards issued by the Secretary of State, NHS England, use the Service User’s verified NHS Number as the consistent identifier of each record on all patient datasets.

12.2.6 comply with the Data Guidance and Data Protection Legislation on the use and disclosure of personal confidential data for other than direct care purposes.

12.2.7 use all reasonable endeavours to optimise its performance to meet the required data completion and data quality metrics indicated in the required information sources listed in this SOP.

12.3 The Managed Access Team may request any information from the provider in addition to that to be provided under Section 12.2 which any commissioner reasonably and lawfully requires in relation to this SOP. The provider must supply that information in a timely manner.

12.4 The Managed Access Team must act reasonably in requesting the provider to provide any information under this SOP, having regard of the burden which that request places on the provider. They may not, without good reason, require the provider:

12.4.1 to supply any information to any commissioner locally where that information is required to be submitted centrally under Section 12.2

12.4.2 where information is required to be submitted in a particular format under section 12.2, to supply that information in a different or additional format (but this will not prevent the Managed Access Team from requesting disaggregation of data previously submitted in aggregated form)

12.4.3 to supply any information to any commissioner locally for which that commissioner cannot demonstrate purpose and value in connection with the discharge of that commissioner’s statutory duties and functions.

12.5 The provider and commissioner must ensure that any information provided to any other party in relation to this SOP is accurate and complete.

Counting and coding of activity

12.6 The provider must ensure that each dataset that it provides under this SOP contains the ODS code and/or other appropriate identifier for the relevant commissioner. The parties must have regard to Commissioner Assignment Methodology Guidance and Who Pays? Guidance when determining the correct commissioner code in activity datasets.

12.7 The parties must comply with guidance relating to clinical coding published by NHS England and with the definitions of activity maintained under the NHS Data Model and Dictionary.

12.8 Where NHS England issues new or updated guidance on the counting and coding of activity and that guidance requires the provider to change its counting and coding practice, the provider must:

12.8.1 as soon as reasonably practicable, inform the Managed Access Team in writing of the change it is making to affect the guidance; and

12.8.1 implement the change on the date (or in the phased sequence of dates) mandated in the guidance.

12.9 Where any change in counting and coding practice required under Section 12.8 is projected, once implemented, to have, or is found following implementation to have had, an impact on the Actual Annual Value of Services, the parties must adjust the relevant prices payable:

12.9.1 where the change is to be, or was, implemented within the contract year in which the relevant guidance was issued by NHS England, in respect of the remainder of that contract year; and

12.9.2 in any event, in respect of the whole of the financial year following the financial year in which the relevant guidance was issued by NHS England, in accordance with the National Tariff to ensure that that impact is rendered neutral for that financial year or those financial years, as applicable.

12.10 Except as provided for in Section 7.8, the provider must not implement a change of practice in the counting and coding of activity without the agreement of the Managed Access Team (cdf@nhs.net or england.imf@nhs.net).

12.11 Either the Managed Access Team (on behalf of the commissioners) or the provider may at any time propose a change of practice in the counting and coding of activity to render it compliant with guidance issued by NHS England already in effect. The party proposing such a change must give the other party written notice of the proposed change at least 6 months before the date on which that change is proposed to be implemented.

12.12 The party receiving notice of the proposed change of practice under Section 12.11 must not unreasonably withhold or delay its agreement to the change.

12.13 Any change of practice proposed under Section 12.11 and agreed under Section 12.12 must be implemented on 1 April of the following financial year, unless the parties agree a different date (or phased sequence) for its implementation.

12.14 Where any change in counting and coding practice proposed under Section 12.11 and agreed under Section 12.12 is projected, once implemented, to have, or is found following implementation to have had, an impact on the Actual Annual Value, the parties must adjust the relevant prices payable:

12.14.1 where the change is to be, or was, implemented within the contract year in which the change was proposed, in respect of the remainder of that contract year; and

12.14.2 in any event, in respect of the whole of the contract year following the contract year in which the change was proposed, in accordance with the National Tariff to ensure that that impact is rendered neutral for that contract year or those contract years, as applicable.

12.15 Where any change of practice in the counting and coding of activity is implemented, the provider and the Managed Access Team must, working jointly and in good faith, use all reasonable endeavours to monitor its impact and to agree the extent of any adjustments to prices which may be necessary under Section 12.9 or Section 12.14.

Aggregation and disaggregation of information

12.16 Information to be provided by the provider under this Section 12 and Section 8 (Information and reporting requirements) and which is necessary for the purposes of provider reimbursement must be provided:

12.16.1 to the Managed Access Team in aggregate form; and/or

12.16.2 directly to the Managed Access Team in disaggregated form relating to its own use of the services, as the Managed Access Team may direct.

SUS

12.17 The provider must submit commissioning data sets to SUS in accordance with SUS guidance, where applicable. Where SUS is applicable, if:

12.17.1 there is a failure of SUS;

12.17.2 or there is an interruption in the availability of SUS to the provider or to any commissioner, the provider must comply with guidance issued by NHS England in relation to the submission of the national datasets collected in accordance with this Section 12 pending resumption of service and must submit those national datasets to SUS as soon as reasonably practicable after resumption of service.

Payment where the parties have not agreed an Expected Annual Contract Value for any services and SUS applies to some or all of the services

12.18 Where the parties have not agreed an Expected Annual Contract Value and SUS applies to some or all of the services, the provider must issue a monthly update of DrPLCM data as per section 7 of this SOP. Subject to 12.20, the commissioner must settle the top up payment within 10 operational days of its receipt (or, if later, within 10 operational days after the relevant first monthly reconciliation date).

Contested payments

12.19 Once the provider has submitted activity data to SUS in respect of a given month, each commissioner may raise with the provider any validation queries it has in relation to that data, and the provider must answer those queries promptly and fully. The parties must use all reasonable endeavours to resolve any queries by the post reconciliation monthly inclusion date.

12.20 If a commissioner contests all or any part of any payment calculated in accordance with this 12.18:

12.20.1 the contesting commissioner must within 5 operational days after receiving the monthly update of DrPLCM data in accordance with 12.18 (or, if later, within 5 operational days after the relevant first monthly reconciliation date), as appropriate, notify provider, setting out in reasonable detail the reasons for contesting that account, and in particular identifying which elements are contested, and which are not contested

12.20.2 any uncontested amount must be paid in accordance with this SOP by the commissioner from whom it is due; and

12.20.3 if the matter has not been resolved within 20 operational days of the date of notification under 12.20.1, the contesting commissioner must refer the matter to the Medicines Negotiation and Managed Access Team, and following the resolution of any dispute referred to the Medicines Negotiation and Managed Access National Team in accordance with this 7.20, insofar as any amount shall be agreed or determined to be payable the Managed Access Team must issue a top up payment for such amount.

Publication reference: PRN01024