Software Vendor Meeting – Wednesday 14 November 2018

Page last updated: 29 March 2019

The Department held a PBS Developers Software Vendors Meeting in Sydney on Wednesday 14 November.

Presentation Material

Minutes

Agenda Item 1 - Welcome and introductions

  • Attendees were welcomed and attendees introduced themselves.

Agenda Item 2 - Electronic Medicine Management Update:

Active Ingredient Prescribing

  • Active Ingredient Prescribing will apply only to computer generated prescriptions where there is a brand substitute available (A or B flag).
    • Alternative brand must be bioequivalent.
  • It is not mandated how this works in software, but PBS scripts will need to identify where items have been adequately flagged
  • There is no mandate for hand written scripts.
  • The prescriber maintains control for determining the most appropriate medicine to prescribe.
    • The Active Ingredient can still be included for hand written scripts, this is a choice of the prescriber.
    • If the prescriber is concerned about the suitability of supplying a generic they can choose ‘brand substitution not permitted’.
  • Vendors raised the possibility for risk of misadventure due to confusion of patients (especially elderly) about brands (i.e. if patient takes both).
    • While this is a consideration, risk already exists, and it should be managed by the Pharmacist and prescriber.
  • Guidelines are being developed for active ingredient prescribing.
  • A question was raised about synonyms.
    • The Australian Digital Health Agency (ADHA) Regulations are not finalised.
    • The ADHA intends to develop a draft implementation process and arrange workshops with stakeholders in order to refine.
    • Stakeholders will be consulted in the active ingredient prescribing.
  • For long names, New Zealand introduced synonyms to assist with fitting on the label.
  • Action: Health will work with ADHA to discuss this option.
  • Note: This will require AMT mapping improvement.

ePrescribing

  • The Government announced the implementation of ePrescribing by the end of 2019.
  • It is an alternative option to paper based, and up to prescribers and their patients.
  • Implementation will require regulatory amendments (legislation) and the development of a technical framework.
  • System changes will be required to enable ePrescribing, with minimal impact to business processes.
  • Health has partnered with ADHA to develop the technical framework.
  • ADHA is setting up a technical working group and Medical Software Industry Association (MSIA) is part of this – software vendors will have opportunity to join discussions through MSIA.
  • The Department of Human Services (DHS) is making changes to its online claiming system as additional data elements are required as part of ePrescribing. This includes:
    • Identifiers for prescriber, dispenser and patient
    • ePrescription flags
    • Conformance identifiers

Agenda Item 3 - Supply/Dispensing only (Supply Only)

  • The current Supply Only mechanism was implemented in 2017 and requires review to support a legislative change in February 2018.
  • Health will consult further with vendors in early 2019 for data changes that may be required to support the new legislation. Vendors advised that system changes will be necessary to update prices and estimated around two to three months of work for testing and data/schema changes.
  • Health proposes that item delists will continue to function as a listing for dispensing, and prescribing will be disallowed.
  • Currently, Supply Only status applies to a whole prescribing rule:
    • Data is populated at a prescribing rule level and all product listings which become Supply Only are claimable under a translated target prescribing rule.
  • Proposed future changes will include:
    • The possibility for different brands within a prescribing rule to have different Supply Only conditions.
    • The possibility to decouple prescribing and dispensing –Health will work closely with stakeholders to implement this process.
    • In most cases, it will not be necessary to translate to another prescribing rule. Health intends to keep this functionality for administrative changes.
    • Dispensing instructions for Supply Only products will be updated along with other standard schedule changes.
    • Validity checks around date of prescribing and date of supply will stand.
  • Responses to questions:
    • Will it cope with manufacture change? Yes
    • Will Supply Only always be for a 12 month period?  No, while all currently apply for 12 months, there may be changes in the future.

Agenda Item 4 - New Dispensing Rules

  • A problem associated with missing dispensing rules in the PBS XML was identified about one year ago. Health is implementing a change to make General, Palliative Care and RPBS programs the same.
  • Hospital dispensing rules have been added to Palliative Care and RPBS programs in the XML.  Test data was posted on 6 October 2018.
  • Health is working closely with Software Vendors and understand that it doesn’t affect everyone.
  • There has been no cessation of the payment of scripts.
  • UPDATE: testing was completed for a March Schedule implementation

Agenda Item 5 - Restriction numbers

  • Two types of codes:
    • 1.  Restriction code
    • 2.  Treatment of code
  • If using text extracts or XLM V2, only treatment of code will be seen.
  • When a new restriction comes in, it will have same number as treatment of code and restriction code.
  • When changes are made to non-legal text, it changes from a data perspective but not a legal perspective.
  • Restriction code updated to a new code but treatment of code stays the same.
  • Only 10,000 4 digit codes remain and it is anticipated that these will be used by early 2020. This means the implementation of 5 digit codes will soon be needed.
  • Health systems and  the XML  cater for 5 digits
  • Health will provide a test file with 5 digit codes with restriction code and treatment of code.
  • DHS confirmed that PBS online can manage 5 digits.
  • Action: Test file to be published on PBS Developer website.
  • Outcome: Vendor concerns should be submitted to PBS.Contact@health.gov.au

Embargo Data Discussion

  • Vendors requested early notice about delays in the receipt of embargo data. Health explained:
    • Often there is pressure for new listings to proceed, requiring external costing negotiations.
    • The listing process involves many stakeholders, both internal and external.
  • Processes are different for all Vendors and therefore data deadlines are different. Vendors advised that data cut-off for the month varied from the 15th to the 21st. Data received after this time jeopardises the data integrity, can have a reputational risk, a financial impact to the end consumers and the supply chain.
  • Vendors requested early advice be provided about the timing for data release and agreed the early release of incomplete data is preferable to waiting on the full set if it is to be late.  Where incomplete data is released, it would be beneficial and would help Vendors manage their small business customers to include a notice to advise vendors in a broad sense, what additional changes are expected.

Agenda Item 6 and 7 - Supply Chain

An overview of the Supply Chain initiative was provided followed by general discussion around wholesaler arrangements. For more detail, refer to the Presentation Material above.

The presenter provided an updated of the XML presentation from Melbourne in Sept – (Improved Payment Administration).  Key points were:

  • Introducing two new concepts:
    • 1. Pricing arrangement 
      • normal or fee-only
    • 2. PuEMP , PrEMP (Published price)
  •  AEMP – what government pays, DHS need to know about it.
    • called the effective price
    • paid to the manufacturer
    • not published
  • PuEMP – published price and the one used to calculate the mark ups and fees
  • AEMP – determined by smallest pack size
    • Equivalent in published price is PuEMP
  • PEMP – price for larger pack sizes
    • Equivalent in published price is PrEMP
  • V3.1 XML schema has been finalised, V2.13 and text extract changes have now been designed.
  • Fee only pricing arrangement will be represented in the data that we publish each month. All of the other items have a normal pricing arrangement.
  • In V3.1 XML, three places where pricing data appears:
    • 1. product listing element (mainly here)
    • 2. pharmaceutical item element
    • 3. TPP element
  • Both V2 and V3 XML already break these down into mark up and fee components, we don’t need to add new data, just need to add identifiers to say what the pricing arrangement is (fee-only or normal).
  • Action: Policy questions to be followed up regarding split/broken packs and dispensed scripts not supplied e.g. patient dies before collecting script.
  • Action: Health to publish beta release of schema packages for XML v2 and txt extracts.

Agenda Item 8 - Radiopharmaceuticals

  • At its November 2017 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of Radium-223 (Xofigo®) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with symptomatic castrate-resistant prostate cancer with skeletal metastases.
  • Radium-223 is be the first radiopharmaceutical to be listed on the PBS.
    • The PBS listing was scheduled to occur on 1 March 2019. However, the drug sponsor (Bayer) has decided not to proceed with the listing at this time.
  • To ensure the listing of Radium-223 is achieved as soon as possible, Health intends to establish an interim implementation approach which will result in Radium-223 listed with the Botulinum Toxin program which has dispensing, prescribing and pricing rules already in place that align with those required for radiopharmaceutical listings.
    • This arrangements will be reconsidered should a radiopharmaceutical listing be required in the future.
  • Action: Vendors asked Health to provide advice on whether prescribing would be dose based or pack based.

Agenda Item 9 - AMT Mapping Update

  • AMT mapping is continuing as a monthly process, but we continue to track at a consistent 91%.  A range of factors are impeding achieving 100%, including:
    • Low level differences can cause concepts to not be reconciled (e.g. flavours, vials vs syringe)
    • System difficulties are a factor which have caused some concepts to be unreconciled
  • Agency and Health are working on better management techniques to increase reconciliation
  • AMT issues should be raised with the helpdesk: helpdesk@healthterminologies.gov.au
  • ADHA staff advising they are exploring a few things to reduce reconciliation process and to add new products as soon as possible. They prioritise PBS data changes
  • Comment was made that Medserve.online – helpful way to find AMT ID-

Agenda Item 10 - PIR: v3.0 PBS XML

  • Version 3 has now been the primary PBS data since implementation in September 2017.
  • Comment from an attendee was that V3 is a significant improvement but form and strength  can no longer be extracted:
    • AMT doesn’t break these apart in preferred terms. The data contains the information but is not an easy process to extract.
  • May 2019 will bring in V3.1 (with Supply Chain).
  • Question was raised about putting more into text file.
  • Outcome: This is being actioned by Health.

Agenda Item 11 - PBS data future direction discussion  

Health continues to look at alternate ways of providing access to PBS data and this agenda item was an open discussion around vendors’ views and requirements.  Key points were:

  • Continued reliance on  text extracts
  • Subsets didn’t deliver the outcome required
  • XML ticks some requirements – good for archiving and auditing but not good for data transition and processing or access to partial subsets
  • Relationships between Health, DHS and Vendors.
  • Need to engage with vendors on requirements, what data is need and for what purpose.
  • We have been working on Health Products Portal (HPP) in Health
    • Changing how PBAC submissions are done (online system) and
    • PBS data distribution
  • Do the current forms of data meet the requirements? (see slides for requirements)
    • Aiming to have a solution that meets all requirements in future
    • Vendors advised that their requirements include:
      • Suggestion to replace XML with SQL
      • Arelational data model is needed
      • Having relational format is a basic business requirement
      • Web service access (v2)
      • Many are implementing FHIR
      • Standards based API e.g. FHIR

Agenda Item 12 - Minutes and action items

  • Minutes will be distributed following this meeting
  • Action items are tabled below

Action Items

Action item number Agenda item Action item Who is responsible Status
1 Electronic Medicine Management Update Health will work with ADHA to discuss the option of synonyms. Health Open
2 Test file to be published on PBS Developers website Test file to be published on PBS Developers website Health Open
3 Supply Chain Policy questions to be followed up regarding split/broken packs and dispensed scripts not supplied e.g. patient dies before collecting script. Health Open
4 Supply Chain Health to publish beta release of schema packages. Health Open
5 Prescribing Vendors asked Health to provide advice on whether prescribing would be dose based or pack based. Health Open