The BOE changes the control of prostheses, wheelchairs, and orthoses financed by public healthcare

The modification of the funding of orthoprosthetic products in the National Health System (SNS) is usually structured by combining Government decisions (on the common service portfolio and benefit catalogs) with regulations with the force of law processed in the General Courts. Parliament sets the basic framework (criteria, spending limits, copayments, etc.) and the Ministry of Health, together with the autonomous communities (CCAA), then specifies the products and funding conditions through regulatory norms. The following describes the usual scheme, not a specific case.

1. Most frequent regulatory routes

To change the funding of orthoprosthetic products, these tools are typically used:

• Ordinary law: it can be a government bill or a private member's bill from parliamentary groups. It is the ideal route to modify the general framework of orthoprosthetic benefits, funding principles, access criteria, or user participation.
• General State Budget Law: each year it can introduce additional provisions affecting the scope of funding, spending caps, user contribution percentages, or specific programs linked to orthoprostheses.
• Royal decree-law: the Government can use it for urgent changes (for example, quickly incorporating certain products into funding or revising user contributions). It requires subsequent validation by the Congress.
• Regulatory norms (royal decrees and ministerial orders): specify the content of the supplementary common portfolio (including orthoprosthetics) and the product catalog, maximum prices, and dispensing conditions. Legally, this is not parliamentary processing but is usually preceded or framed by Parliament decisions.

2. Parliamentary phases in Congress and Senate

When the modification goes through an ordinary law or the validation/reform of a royal decree-law, the general legislative procedure is followed:

• Initiative: the Government approves a bill in the Council of Ministers or issues a royal decree-law, or a group presents a private member's bill. The Congress Board qualifies the initiative and admits it for processing.
• Publication and total amendments: once published in the Congress Bulletin, a period (usually about 15 days, extendable) opens for groups to register total amendments or, in the case of private members' bills, request consideration.
• Total debate in Plenary: it is discussed whether the text should continue processing. Its return to the Government (in bills) can be approved or the consideration can be rejected (in private members' bills), which would block the funding reform.
• Partial amendments and Committee: after passing the total phase, another period (again about 15 days) opens for amendments to the articles. The Health Committee (or other competent) debates the text article by article, votes on amendments, and approves a report.
• Congress Plenary: the report is submitted to the Plenary. Amendments still alive are discussed and voted on. The resulting text, if approved, is sent to the Senate.
• Processing in the Senate: the scheme is replicated: amendments, debate in committee and Plenary. The Senate can approve the text as is, introduce amendments, or veto it.
• Final response of the Congress: the Congress decides whether to accept or reject the Senate's amendments and can override a possible veto by absolute majority (or simple majority after two months).
• Sanction and publication: the law is sent to the King for sanction and published in the BOE, entering into force on the set date.

3. Role of the Government and autonomous communities

In health, the State sets the basic regulation and common portfolio, while the CCAA manage the benefit and can expand services charged to their budgets. Usually:

• The central Government drives the change (bill or royal decree-law) to adapt the basic regulation and general funding rules.
• The CCAA participate in the technical definition through the Interterritorial Council of the SNS, issuing reports and agreeing on criteria for product inclusion, groupings, clinical indications, etc.
• Once the basic norm is modified, the Ministry of Health approves the regulatory norms that update catalogs and conditions, which the CCAA apply in their own prescription and supply system.

4. Incorporation into the SNS common portfolio

The parliamentary change usually does not detail product by product but enables and guides the Government. Afterwards:

• The supplementary common portfolio of the SNS is updated, where orthoprosthetic benefits are framed, specifying which types of products are funded and under what criteria.
• The catalogs of orthoprosthetic products are reviewed, with codes, technical characteristics, and maximum funding prices.
• User contribution regimes (if any), funding limits, and conditions for exempt or specially protected groups are established or adjusted.

Overall, Parliament sets the legal and budgetary framework, while Government and CCAA technically specify which orthoprosthetic products are funded, with what intensity, and under what conditions within the SNS.

The Ministry of Health has, according to current regulations, a central role in the basic regulation of orthoprosthetic products as part of the service portfolio of the National Health System (SNS) and as a specific category of medical devices. Its powers include defining the portfolio and the common catalog, setting maximum funding amounts, the general ordering of fundable supply, and coordination with the autonomous communities, while the latter manage prescription, provision, and requirements of establishments. Additionally, the Ministry acts, directly or through the Spanish Agency of Medicines and Medical Devices (AEMPS), as the state authority in medical devices in general.

General framework: Law 16/2003 and Guarantees Law

Law 16/2003, on cohesion and quality of the SNS configures the benefits and the common service portfolio. The relevant excerpt establishes that:

• The SNS service portfolio is approved by royal decree, after a report from the Interterritorial Council.
• The update of the service portfolio is approved by order of the Minister of Health, also after a report from the Interterritorial Council.
• The Ministry of Health, after a report from the Interterritorial Council, can authorize supervised use of certain techniques, technologies, or procedures before their inclusion in the portfolio.

Additionally, the same law dedicates a specific chapter to the exclusive powers of the State in evaluation, registration, authorization, surveillance, and control of medicines and medical devices, establishing reinforced coordination between the Ministry and the AEMPS, and assigning to the former the decision on public funding and pricing of medicines and medical devices once authorized.

This scheme is integrated with Royal Legislative Decree 1/2015 (consolidated text of the Law on guarantees and rational use of medicines and medical devices), where ministerial powers on quality controls, information, national codes, etc., are reiterated, although without entering into the specific detail of orthoprosthetic benefits.

Service portfolio and orthoprosthetic benefit

Royal Decree 1030/2006 defines the common service portfolio of the SNS, explicitly including the orthoprosthetic benefit among common benefits. Its objectives include:

• Establishing the content of the common service portfolio, including the orthoprosthetic benefit.
• Setting the bases of the update procedure of the portfolio.

This royal decree is specifically developed for orthoprosthetics by Royal Decree 1506/2012, which sets the more specific competential framework of the Ministry in this matter.

Specific powers of the Ministry on orthoprosthetic products

From Royal Decree 1506/2012 and its development by Order SCB/45/2019, the following specific powers of the Ministry of Health emerge, synthetically:

1. Definition of the supplementary common portfolio and the common catalog

• Outpatient orthoprosthetic benefit is integrated into the supplementary common portfolio of the SNS (art. 8 of Law 16/2003, as cited in Order SCB/45/2019).
• The content of this supplementary portfolio is specified in a common catalog of orthoprosthetic benefits, which:

According to RD 1506/2012 and Order SCB/45/2019:

• Is established and updated by order of the Minister of Health, after agreement of the Interterritorial Council and proposal of the Commission of benefits, insurance, and funding.
• Determines which types of products (external prostheses, wheelchairs, orthoses, special orthoprostheses, certain implants) are part of the common portfolio and, therefore, are fundable at least throughout the SNS.

2. Creation and management of the "Offer" of fundable products

RD 1506/2012 introduces the SNS orthoprosthetic products Offer, and assigns the Ministry the following functions:

• Create and configure the Offer as a set of orthoprosthetic products susceptible to funding by the SNS.
• Manage said Offer through the General Directorate of Basic Service Portfolio of the SNS and Pharmacy, as the body responsible for ordering benefits.
• Set, by ministerial order, the product types within each code or subgroup and the maximum funding amounts for each type.
• Accept the Offer price proposed by companies for each product, which must be equal to or less than the maximum funding amount.

3. Setting criteria for inclusion, alteration, and exclusion

Order SCB/45/2019 develops, in execution of RD 1506/2012, the procedure by which the Ministry:

• Establishes the criteria for inclusion of products in the Offer and common catalog (safety, efficacy, effectiveness, efficiency, care alternatives, economic and organizational impact, etc.).
• Regulates the procedures for inclusion, alteration of use conditions, and exclusion of orthoprosthetic products from the Offer.
• Articulates the participation of interested third parties (patient associations, scientific societies, companies) in proposals for updating the common portfolio.

4. State–CCAA coordination and role of autonomous communities

Both RD 1506/2012 and Order SCB/45/2019 delimit that:

• The autonomous communities, INGESA, and mutual societies prepare their own catalogs selecting products from the Offer and can, with sufficient financial conditions, expand the common catalog.
• The autonomous communities determine the requirements of orthopedic dispensing establishments and organizational aspects of the benefit.

The Ministry, therefore, sets the state bases (portfolio, common catalog, Offer, maximum amounts, technical criteria) and coordinates through the Interterritorial Council, while the CCAA manage the specific benefit.

Orthoprosthetic products as medical devices

Finally, orthoprosthetic products, as medical devices, are also subject to the general regime of Royal Decree 192/2023, which:

• Determines the competent authority in medical devices and the health guarantees they must comply with.
• Regulates, in coordination with the AEMPS and autonomous communities, the licenses for manufacture, import, surveillance, and market control of medical devices.

In this area, the Ministry exercises the state normative function of developing Regulation (EU) 2017/745, establishing the general framework of safety, surveillance, and control also applicable to orthoprosthetic products.

For an orthoprosthetic product to be funded in the supplementary common portfolio of the National Health System (SNS), it must first be a medical device that complies with all current legislation and, second, fit into the groups and types defined in the common catalog of orthoprosthetic benefits. On that basis, only those included in the SNS Product Offer that pass an evaluation of safety, efficacy, effectiveness, and efficiency, and that meet strict requirements of denomination, labeling, price, and information are included. The inclusion, alteration, and exclusion procedure is mainly regulated by Royal Decree 1506/2012 and Order SCB/45/2019, complemented by update orders of annex VI of Royal Decree 1030/2006. The essential requirements and applicable regulations are detailed below.

Basic applicable regulations

The state framework relies on several key norms:

• Royal Decree 1030/2006, of September 15, which establishes the common service portfolio of the SNS and defines in its annex VI the orthoprosthetic benefit (surgical implants and external orthoprostheses).
• Royal Decree 1506/2012, of November 2, which regulates the supplementary common portfolio of orthoprosthetic benefits and the bases for maximum funding amounts, according to the publication in the BOE.
• Order SCB/45/2019, of January 22, which modifies annex VI of Royal Decree 1030/2006, regulates the procedure for inclusion, alteration, and exclusion of the Orthoprosthetic Product Offer and sets correction coefficients, according to the published order.
• Order SCB/480/2019, of April 26, which updates various sections of external prostheses of annex VI, according to the order.
• Order SND/44/2022, of January 27, which updates the common catalog in external prostheses of upper and lower limbs, orthoprostheses for agenesis, wheelchairs, orthoses, and lymphedema therapy, according to the 2022 order.
• Order SSI/1356/2015, of July 2, which had already updated the common catalog of surgical implants, included in this order.

General product requirements to be fundable

According to article 7 of Royal Decree 1506/2012, only orthoprosthetic products that simultaneously meet, among others, the following requirements are included in the SNS Offer:

• Medical device legislation: they must comply with all requirements of current medical device regulations (an essential condition to be a fundable orthoprosthetic product).
• Fit in annex VI of RD 1030/2006: they must correspond to one of the groups or subgroups of surgical implants, or to the homologated codes of external orthoprostheses in annex VI of Royal Decree 1030/2006.
• Classification in a product type: they must belong to one of the product types defined by ministerial order, within each homologated code or subgroup.
• Labeling and information: labeling must clearly reflect the product indications, without phrases, drawings, or motives that lead to confusion, and without advertising other products.
• Denomination and no confusion: they must have a generic denomination accompanied by a brand or company name, and cannot use names identical or similar to other orthoprosthetic products, medicines, other medical devices, or dietary products that could cause error.
• Price in line with the maximum funding amount: the price proposed by the company cannot exceed the maximum funding amount (IMF) set for its product type.
• No advertising to the public: the product is not allowed to advertise to the general public.
• Specific technical requirements: when they exist, they must comply with the technical requirements developed by the Ministry of Health for each product type, proposed by the Advisory Committee for orthoprosthetic benefits.

Common catalog, safety, efficacy, and cost-effectiveness

The supplementary common orthoprosthetic benefit catalog, developed through orders such as SCB/45/2019 and SND/44/2022, is the mandatory minimum reference for all autonomous communities and mutual societies. Royal Decree 1506/2012 itself establishes that its content is set taking into account the safety, efficacy, effectiveness, and efficiency of products, as well as care alternatives, social needs, vulnerable groups, and economic and organizational impact.

The common catalog determines for each product type:

• Its classification by groups, subgroups, and homologated codes.
• Its average lifespan, as a minimum quality guarantee funded by the SNS.
• The maximum funding amount (IMF) applicable when dispensed to SNS users.

Inclusion, alteration, and exclusion procedure

Royal Decree 1506/2012 provides that the procedure will be set by ministerial order, a function fulfilled by Order SCB/45/2019. The essential elements covered by the norms are:

• The holder company must request inclusion of the product in the Offer before the General Directorate of Basic Service Portfolio of the SNS and Pharmacy, providing the required documentation (including economic and technical information, channeled through systems such as SIRPO/OFEPO).
• The Subdirectorate General of Service Portfolio assesses whether the product is fundable applying the criteria of article 7 of Royal Decree 1506/2012.
• If the product meets the requirements and its price fits the IMF, it is assigned an identification code and incorporated into the Offer nomenclature.
• Exclusion can occur, among other reasons, if it ceases to comply with current legislation, if the product type is excluded from the common catalog, if the risk/benefit balance becomes unfavorable, or if it advertises to the public.
• Companies must renew the Offer information every three years; failure to do so may result in product removal.

Prescription and relationship with the patient

The common catalog indicates cases of special prescription where products must be indicated by physicians from designated units, according to indication protocols and, if applicable, orthoprosthesis follow-up. Additionally, the norms require clear labeling, without advertising and without inducing error, which translates into obligations of objective information to the patient. The autonomous communities, INGESA, and mutual societies evaluate prescriptions by areas and population groups to promote rational use of orthoprosthetic products and guarantee a safe, effective, and cost-effective benefit.