What is the role of the PCRS?

In the context of healthcare and pharmacy services provided by pharmacists under the community pharmacy contractual agreement, it is the responsibility of the PCRS, to review and validate reimbursement claims, ensuring that the patient is eligible for the supplied medication and that the quantities requested do not exceed the ‘reasonable needs’ of the patients being treated.

 

What is normative patient use?

Under the community drug schemes, the PCRS will only reimburse a pharmacy for a one-month supply of medications. However, to allow for the shortfall, due to pack sizes, in a 12-month period, pharmacies are allowed to dispense an extra pack of medication. So, if a pack was on a 28-day cycle, pharmacists can supply 13 packs in a 12-month period. The packaging of a particular item will determine whether the thirteenth dispensing is required by the patient in a 12-month period.

Standard practice for PCRS is to reimburse a pharmacy up to the maximum quantity as specified in the Summary of Product Characteristics (SmPC) for a medicine required by a patient per calendar month. These limits are specified within the pharmacy contract, which states:

“4(2) ‘Where a prescription is issued in respect of a quantity of a medicine which does not conform to the amount in the pack presentation of the product which is available on the market, the pharmacist, in the exercise of his/her professional judgement and discretion, may supply the quantity in the nearest pack presentation provided that the quantity so supplied is not normally greater that one month’s supply for the patient concerned.”

As PCRS does not publish what it deems as acceptable monthly usage for all reimbursed items, the SmPC should be used as a guide in setting the maximum quantities to supply to any one patient. In exceptional circumstances where quantities are dispensed outside the recommended allowances, pharmacists should check with the PCRS if the prescribed quantity will be reimbursed in full before any additional supplies are made to a patient. Additional documentation may be requested to support these claim types.

 

Navigating the complexities

The Health Pricing and Supply of Medical Goods Act 2013, implemented various measures to generate cost savings for the HSE, for patients or both, and to establish mechanisms to set reimbursed prices for items dispensed under the community drug schemes. Implementing this legislation with the associated increase in PCRS circulars has contributed to the increasing administrative burden experienced within the community pharmacy practice.

In addition to the establishment of an interchangeable medicine list and reference pricing, this legislation enabled the HSE to impose conditions on the supply of some reimbursable items, including:

1. Protocols for the supply of listed items;
2. Quantities that may be supplied or reimbursed, in respect of a patient or class of patients;
3. Period for supply or reimbursement restrictions of listed items;
4. Restrictions on the purpose for which a listed item can be supplied;
5. Restrictions on who can prescribe listed items; and
6. Restrictions on the classes of patients who may be supplied with, or reimbursed for, a listed item.

 

Medicines Management Programme

The HSE established the Medicines Management Programme (MMP) in 2013 to promote safe, effective, and cost-effective prescribing practices. Through collaborative efforts with the National Medicines Information Centre (NMIC), the National Centre for Pharmacoeconomics (NCPE), and the PCRS, the MMP plays a crucial role in the medicines management process, accessibility to medicines, and the optimisation of overall expenditure on pharmaceuticals.

The Medicines Management Programme has undertaken a number of initiatives aimed at enhancing evidence-based and cost-effective prescribing nationally. Some examples include:

• Preferred Drugs Initiative;
• Prescribing Tips and Tools; and
• Prescribing and Cost Guidance.

  Table 1: Summary Listings Information Fully Paid Rejected

How do pharmacists know their level of rejected claims?

Pharmacists will be able to determine the level of rejected claims for their pharmacy by the information in the DPS/LTI summary listing booklets provided by the PCRS. The final page of this document provides valuable information on the percentage of claims that have been fully paid, as well as those initially rejected and finally rejected, for the individual pharmacy in comparison to the national average (see Table 1 below).

Table 1: Summary Listing Information

	Fully paid	Rejected initially	Rejected finally	Difference in items
Your pharmacy	99.69%	0.31%	0.00%	0.00%
National Average	98.73%	0.84%	1.27%	0.00%

 

Once the electronic claim file has been transmitted at the end of the month to the PCRS, the exceptions file will be available for download within 24 hours. Downloading the early exception file and resubmitting your rejects helps pharmacists to minimise any financial loss from the end of month process, before the rejected claims move to become final rejects. It is important to build in time into your dispensary operations to download these and resend them within the claim period. The full claim reject listing will outline any items/forms that the PCRS has identified as rejected claims.

 

Did you know?

14% of pharmacies do not resubmit rejected claims for payment![1]  

Reasons for rejected claims

Many items featured on the reimbursement list require individual and complex approval processes, each with its own unique requirements and set of rules. Several items under the community drug schemes have reimbursement restrictions, particularly in terms of the quantity of items that can be supplied. For example, medications such as PDE5 inhibitors (Sildenafil & Tadalafil) are subject to quantity limitation specified in PCRS Circulars. If pharmacists supply quantities beyond these limits to patients under the community drug scheme, they risk financial losses and will not receive reimbursement for the total number of supplied items. Specific individual eligibility approval for reimbursement of an item can also occur, where the HSE agrees to reimburse a medicine for a specific population or a specific condition. Approvals can be granted for an indefinite period or a specific timeline, with the requirement for review after a specific interval has elapsed. In the case of certain products such as Cariban®, the reimbursement application must be initiated by a consultant responsible for the treatment of the individual and must be applied for through the PCRS Hospital Application Suite.

Occasionally, the same item can have more than one type of restriction applied e.g. Saxenda®. Saxenda® supplied under the community drug schemes is restricted to specific patient categories that meet the criteria as per PCRS Circular 002/23 for a limited time and the reimbursed quantity of Saxenda, it is limited to just one box per month.

Examples of restricted items:

2. A number of items have some element of additional approval such as Rivaroxaban (Xarelto®) 2.5 mg and Sacubitril & Valsartan (Entresto®);
3. PDE5 drugs are an example of a product type that has a quantity restriction (max 4 tablets per month);
4. Items with a time restriction include PrEP and Oral Nutritional Supplements, a renewal of the application is required for these;
5. Different items that have restricted use, an example of this is Lidocaine 5% patch. Reimbursement is restricted to its licenced use for symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection known as post-herpetic neuralgia (PHN) in adults;
6. Prescriber restriction for reimbursement purposes: Heart Failure Specialists must initiate and apply for Entresto® approval, Diabetic Specialist Team authorises approval for Dexcom® G6 monitors and Cariban® is prescribed by the Consultant Obstetrician; and
7. Restrictions on patient groups who can be prescribed an item and receive reimbursement under the community drug schemes: Saxenda® (GMS and DPS only), Fampyra® (GMS and LTI only).

 

Establishing reimbursement quantities

As part of cost-containment measures and ongoing evaluations, the PCRS has set limits for high-cost items and/or items with ambiguous dosages. The PCRS employ clinical guidance to manage reimbursement quantities for these items. Rather than an outright reject, the PCRS may reduce the payment to the pharmacy based on maximum allowed quantities. Therefore, it is crucial for pharmacists to exercise scrutiny when reviewing paid claims to identify any such adjustments, the PCRS produce a monthly XML claim file that will help identify these discrepancies.

 

Oral Nutritional Supplements (ONS)

A wide range of conditions may require nutritional support, but dispensing ONS on a repeat GMS prescription (GMR) is not permitted for reimbursement purposes. Standard Oral Nutritional Supplements (ONS) that do not necessitate reimbursement approval prior to supplying are included in the first-line prescribing list for adults living in the community, established in 2019.  However, for non first-line ONS (list B), prior reimbursement approval is mandatory before dispensing under the community drug schemes. The comprehensive overview of List B is available on the Medicines Management Programme webpage for Oral Nutritional Supplements. The approval for these items remains valid for up to six months and is prescriber-initiated. Continuing ONS when treatment objectives have not been achieved is not good practice, so the approval is subject to renewal.

 

“ If pharmacists supply quantities beyond these limits to patients under the community drug scheme, they risk financial losses and will not receive reimbursement for the total number of supplied items.”

 

Patient allowance on Blood Glucose Strips

The recommended blood glucose test strips (BGTS) allowances are recommended in HSE Circular 011/16 which outlines the restrictions for differing diabetic conditions as follows:

• There will be no limit on the number of boxes of single use test strips for patients treated with insulin;
• Patients managed on sulphonylurea or meglitinide drugs will be reimbursed for 2 boxes of test strips per month i.e. 1,200 test strips/annum;
• Patients managed on oral hypoglycaemic drugs other than sulphonylurea or meglitinide drugs will be reimbursed for one box of test strips per month i.e. 600 test strips/annum; and
• Patients managed through diet alone will be reimbursed for 2 boxes of test strips per annum i.e. 100 test strips/annum.

Women diagnosed with gestational diabetes who have current GMS eligibility must have their physicians register them online for full access to diabetic strips without a threshold. Patients with gestational diabetes are not entitled to apply for LTI eligibility based on their condition. For patients with DPS eligibility who have been diagnosed with gestational diabetes a maximum of 250 strips a month will be reimbursed under this scheme, no additional registration is required for these DPS patients.

 

Managed Access Protocols

The HSE has established managed access protocols to address the clinical and financial implications related to specific high-cost medicines and devices. This is a restricted reimbursement application system that not only considers patients’ eligibility but also serves to manage the impact of these products on healthcare budgets. By implementing this system, the HSE aims to ensure that the reimbursement of these items is carefully regulated and aligned with established criteria and guidelines. Pharmacists can verify approval using the ‘Eligibility Confirmation’ feature within the Pharmacy Application Suite under ‘Patient Specific Arrangements’. Claims submitted for patients who are not approved will not be paid.

 

Flash and Continuous Glucose Monitoring System (FGM and CGM)

Due to the budget impact associated with continuous and flash glucose monitoring systems, PCRS has a reimbursement application system in place. The reimbursement application can be made by a Consultant Endocrinologist responsible for initiating treatment through the PCRS Hospital Application Suite.

 

Supervision and oversight

While there are no official restrictions on the following items, there are exceptions that undergo monitoring:

• Infusion products: MiniMed Mio Advance infusion and reservoir — recommendation is to change the infusion site at least every two days (48 hours) for steel needle sets, and every three days (72 hours) for soft cannula sets, so two boxes of ten infusion sets and associated reservoirs should be a monthly dispensing quantity;
• Continuous Glucose Monitoring (CGM) systems:
• The ‘restriction’ for Guardian sensors is one box per month;
• Dexcom G6 Sensor has a duration of use of ten days. The package includes three sensors, which will provide an adequate supply for one month, the transmitter is provided directly to patient by Local Health Office; and
• Dexcom G7 rtCGM contains one 10-day sensor only. Pharmacists can dispense three boxes to cover a one-month supply. (Each patient is entitled to a maximum of 37 sensor boxes of Dexcom G7 rtCGM per year.)

 

If a patient reports a fault with an FGM or CGM product, a replacement must be sought from the manufacturer and not through a repeat dispensing.

 

Training Supports available for Pharmacists

To support pharmacists in identifying reimbursement issues before dispensing, we have compiled a comprehensive Restricted Reimbursement Guide and a Summary of Items with Restrictions Guide outlining the current known reimbursement restrictions. IPU members can locate these documents at www.ipu.ie > Contract > Reimbursement.

Increasing awareness and facilitating appropriate management of reimbursement considerations within a pharmacy practice will reduce rejected claims, if you need more support please contact contract@ipu.ie.

[1] PCRS Rejects Report for August 2022 with post corrections up to 9 months after