First Meeting of the Italian Regional Purchasing Centers
Italian public healthcare structures can buy medical devices only via tenders. Up to 2016, competitive pricing was the main rule for tender winners. Since then, the Price/Quality criteria can be applied in the rate of 70/70, 50/50, usually 30/70. Quality is not anymore limited to the functional and esthetic products features and its handling use. The attention is now focused on the commercialization phase, innovative and efficacy features, profitability and usability of instruction for final users, as well as Eco-friendly features. Companies’ organization procedures and professional training can be also valued in tenders protocols.
How has quality declined in the regional tenders over the last 3 years? This was discussed in the first regional Purchasing Centers conference in May 2019 in Florence.
The main Italian regional purchasing centers, representing 78% of them (Azienda Zero- Veneto Region; SCR-Piemonte Region; Intercent-er Emilia Romagna Region; Soresa, Campania Region; Centro per gli Acquisti Lazio Region, SUA Abruzzo Region, Estar Toscan Region), under the framework of FARE (Federazione delle Associazioni Regionali Economi e Provveditori della Sanità), the Italian Association of purchasing managers, selected their subject for the conference from the National Catalogue of Medial Devices and compared protocols of performed tenders using the same template. Diabetes micro pumps, endoprosthesis, stents, stomia medical devices, and defibrillators were some the conference subjects.
Reading in parallel the results, it showed that tenders protocols were homogeneously drafted in some of their main chapters: medical devices need definition (mostly based on epidemiological or healthcare structures local database data collection/estimates), implementation of the companies hearing phase (mostly web-based or email based), application of the so-called Accordo Quadro.
This latter is widely chosen as tender strategy. It is a specific purchasing pattern in which Companies, selected on the basis of the tender protocol, can participate to a specific agreement with the Purchasing Centers defining only selling price and quality parameters: the next purchasing contract is locally defined. This agreement has the main advantage of not excluding any Companies from the “winners” and allows healthcare structures to provide to patients the appropriate medical devices they need in the framework of a tender.
A further common action is the presence Clinicians in the Technical Committees: they play a key role in the identification and definition of tenders’ minimum, potentials and not fungible criteria. Pharmacists, Purchasing Managers and Administrative Personnel mostly decline Clinicians requirements in technical items.
Diversity regarded timing to perform the tender which depended from the complexity of the medical devices to be discussed. Moreover, diversity regarded the specific task of the Purchasing Center. For example, Estar also has function of storage of medical devices and drugs. This is absolutely a great advantage in the estimation of products need due to the availability of data from the regional database.
More relevant is the different link with the Regions. Estar for instance must comply the purchasing assessment to the regional guidelines, if delivered: for example, the stomia medical devices tender was based on the regional guidelines. Others also work in perfect alignment with the regional government: Intercent-er could create ad hoc technical committees including regional politicians (example: endoprosthesis tenders), the Centro per gli Acquisti Lazio Region implemented the diabetes medical devices tender in agreement with the Region and Federfarma (i.e. the regional retail pharmacies network).
In conclusion, this first experience of networking of the regional Purchasing Centers was the first step to identify appropriateness and improvement areas in the Quality definition in the purchasing patterns of medical devices in Italy. Thus, it implies for Manufactures the possibility to better understand and interact with the Purchasing Centers and consequently align with their Quality requirements.
Boston Healthcare Associates assists our clients with market access challenges in Italy due to our long-term partnership with local consultants. To learn more, please contact us.
CMS Proposes Changes to Part B Medicare Reimbursement for Physician-Administered Drugs Approved Under the 505(b)(2) Approval Pathway
The Centers for Medicare and Medicaid Services (CMS) intends to alter assignment of Healthcare Common Procedure Coding System (HCPCS) Level II codes for certain physician-administered 505(b)(2) drugs.
Recently, Medicare published two CRs associated with the NGS NCD, identifying covered tests and associated CPT and ICD-10 diagnosis codes. These CRs (CR11655 and CR11749) indicated that MSK-IMPACT and MyMRD NGS Panel were nationally covered under the NGS NCD.
G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case
In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without complete clinical data at the time of approval.