Change in regulations for prescription medical devices

The draft introduces changes in response to the demands of patients, doctors and patient organizations. The purpose of these proposals is to correct and make more specific the current regulations, thereby eliminating problems of interpretation.

Key substantive changes include:

1) Correction of the catalog of persons authorized to issue orders for the supply of medical devices;

2) To standardize to a percentage format the entries in column 5 of the annex to the regulation regarding the amount of the recipient's own contribution to the public funding limit (codes Z.03.01, Z.03.02 and Z.03.03);

3) Correcting the mutual exclusions of simultaneous supplies under the award criteria for respiratory support medical devices (codes U.03.01, U.03.02, U.04.01 and U.04.02) and wheelchairs (code S.15.01);

4) To clarify the award criteria for compression corsets (bras) (code N.16.01) and post-surgical or breast prosthesis bras (code Z.01.02) by excluding the possibility of supplying swimwear;

5). Restore the possibility of reducing the useful life for orthopedic footwear (codes M.01.01, M.02.01, M.03.01, M.04.01 and M.05.01);

6) Adjustment of the award criteria to allow the supply of corrective spectacle lenses for near and far with prismatic power in the case of visual impairment requiring correction sphere from ± 6.25 dptr and cylinder from 0.00 dptr (codes O.01.01 and O.01.02);

7) clarification of the eligible maximum number of supply units for transmitters/transmitters for the real-time continuous glycemic monitoring system (CGM-RT) requiring replacement less than once every 3 months in a manner consistent with the required frequency of replacement on the scale established in the Annex to the amended regulation of the useful life, which is once a year (code R.04.02);

8) Adjustment of the award criteria clarifying the maximum number of sensors for the flash glucose monitoring (FGM) system subject to reimbursement within a range of consecutive 6 calendar months (code R.05.01);

9) Restoration of the clarification of the bias of hip orthoses (codes H.05.01 and H.05.02) and the wording of the parts of the lower limb covered by the orthoses as defined by codes G.05.01 and G.05.02.

Source: RCL