Major changes in contract medical device financing. The project – Puls Medycyny has been published

A draft regulation from the Minister of Health was published on the website of the Central Government Legislation Center on Friday (8 July), amending the regulation on the list of medical devices provided on request. This is a very broad category – including wheelchairs, so-called nappy pants, hearing aids, spectacle lenses, catheters or electronic devices that monitor specific health parameters.

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The limits for active wheelchairs have been increased significantly – PLN 2,000 or PLN 4,500 – depending on the weight of the wheelchair, as well as for power wheelchairs (5,000 PLN).

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The aim of the proposed amendment is to increase patient availability for medical devices that are provided on request and to make the applicable provisions more detailed to resolve interpretation issues.

See the entire draft regulation from the Minister of Health to amend the regulation on the list of medical devices provided on request.

Financing of medical devices on request. a list of changes

As we read in the justification, the proposed amendment changes the Annex to the Regulation to meet the needs of patients, doctors and patient organisations. What exactly will change?

  1. Fee changes have been made flat bed products specified in No. 69 and 70 of the Annex to the Regulation, with detailed limits depending on the product model, as well as serial and custom production.
  2. The limit has been increased in the range corrective lenses for near and far (item 73 and item 74) above 6.25 diopters, and the patient’s own participation in the limit was reduced to 10%. Case limit has been increased contact lenses hard (no. 75) and the beneficiaries’ share was reduced to 10% of their purchase.
  3. The limit has been increased for item no. 79 (up to PLN 200) and 80-83 (up to PLN 400).
  4. The limit has been increased hearing aids for air conduction, both for children and adults (Article 84 increases the limit for children from PLN 2,000 to PLN 3,000, for adults from PLN 1,000 to PLN 1,500). In the case of bone conduction devices (item 85), the limit was increased from PLN 1,800 to PLN 3,000, both for children and adults. In addition, the personal contribution in the case of hearing aids (item 86) has been reduced from 50% to 30%.
  5. Changes have been made to the No. 89, allowing a refund for both tracheostomy tubes with a spare filling (the limit of PLN 150 remains) and silicone (the limit of PLN 235), as well as the number of pieces to which patients are entitled is increased, depending on the type of tube. A minimum share of the 10% limit has been introduced for adult patients.
  6. Reimbursement extended infusion sets for a personal insulin pump (Item 91) for the indication: Type 3 diabetes, and a provision was introduced allowing reimbursement of sets for drainless pumps, which was not possible due to the structure of the provisions in force to date.
  7. In no. 97 and 98, the rules for reimbursement were united urine collection bagsand a separate category of straps for securing urine collection bags has been introduced with a maximum of PLN 25 each, once every 6 months, for the following indication: diseases requiring catheterization of the urinary bladder; diseases requiring the use of external catheters; bladder drainage; nephrostomy.
  8. There have been significant changes in compensation ostomy pouches (lp. 99), the reimbursement of which has hitherto not included unit limits, but general limits, which could be freely used by patients. Besides, no. 140-142, so a separate reimbursement for ostomy bags in the two-part system and for products for removing and closing ostomy bags. In addition, the option of continuing the assignment by a nurse or midwife as referred to in art. 15a member. 1 and 2 of the law of 15 July 2011 on the professions of nurse and midwife up to 6 months from the date indicated in the medical documentation, related to the need to verify the type of devices and their adaptation to the needs of the patient .
  9. In issues 100 and 101 the category was made more specific absorbent products subject to reimbursement, and an additional limit of PLN 2.3 has been introduced, with own share of 30% for absorbent products above 930 g. In the case of the limit of PLN 1, the minimum absorbency has been increased to 450 g.
  10. The reimbursement limit is on CPAP (lp. 102) is divided into a mask and a camera, which is related to faster wear of masks compared to cameras (the limit of replacement every 6 months for the mask and every 5 years for the camera).
  11. In case of products for patients with cystic fibrosis and primary ciliary dyskinesia the frequency of the exchange was increased (items 102 and 103). In addition, the limit is on nebulizers (Item 102) has been reduced to PLN 70 and the limit to pneumatic inhalers (Item 103) to PLN 250. The limit for individual respiratory physiotherapy equipment – Drainage devices that generate elevated or variable expiratory pressure (Item 105) has been increased to PLN 450.
  12. The compensation is extensively arranged wheelchairs (No. 127, 129, 130 and 131). The categories are described in detail, as are the designations, the classification is made according to the types of trolleys (standard, active and special, in which category the electric trolley is also classified). The limits for standard trolleys were maintained, as was the case with almost all special trolleys previously categorized (except for stabilizing trolleys, the limit of which was reduced to 2,000,000 PLN, due to the analysis of market prices indicating prices below the limit ). The limits for active wheelchairs have been increased significantly – PLN 2,000 or PLN 4,500 – depending on the weight of the wheelchair (this category is also accurately described by weight), as well as for power wheelchairs (5,000 PLN).
  13. Access to refunds has been extended insulin reservoirs for a personal insulin pump to 5 for patients with type 3 diabetes (item 134).
  14. Changes to No. 135 and 136 were intended to adapt the reimbursement to products available on the market, the limits were adapted to the currently ordered CGM-RT types, to take into account all their types and frequencies of replacement. The population is not extensive. A restriction on the reimbursement of strips has been put in place due to the type of CGM-RT used (depending on calibration needs or not).
  15. Refund Introduced HME heat and moisture exchangers (Item 138) up to 30 pieces per month, both placed on tracheostomy tubes with a spare cartridge (maximum PLN 5.8 for 1 item), silicone tubes (PLN 7.2 for 1 item) and directly on the tracheostomy using fixation plaster (PLN 7 ,2 for 1 pc.), for which a separate category with a limit has been created (No. 139).
  16. The indications for ordering have been extended sensors for the glucose monitoring system Flash (Flash Glucose Monitoring – FGM) at:
  • pregnant and maternity women with diabetes who need intensive insulin therapy;
  • blind people with diabetes who are treated with insulin;
  • people over the age of 18 with diabetes who need intensive insulin therapy.

In the case of the latter group, the conditions for the continuation of the order were introduced:

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  • assessment of glycemic control at least every 6 months;
  • TIR (time in range) in the range 70-180 mg/dL > 70% of the time or HbA1c below 7.5% or other individually defined therapeutic targets in collaboration with the physician;
  • wear the sensor at least 75% of the time.

Due to the lack of the need to calibrate FGM, a restriction has been put in place that the number of blood glucose test strips prescribed to patients should not exceed 50 pieces for 6 months.

The order frequency has been changed to 6 months and the number of pieces has been increased to 13 to ensure a continuous supply of sensors. Changes have been made to the category of personnel authorized to outsource item numbers. 135-137, which was related to changes in the target population, and in the case of no. 137 the need to monitor performance to continue engagement.

The limit for personal contributions by children has been lowered to 20%.

It is estimated that the changes introduced annually mean an increase in expenditure of about PLN 250 million. Because of the fact that the proposed amendment may enter into force on 1 December 2022 at the earliest. (based on appointment time and a 3-month deadline for adapting the NFZ IT systems) it is assumed that in the first year the costs for the National Health Fund could be 25 million PLN.

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