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Order Ssi/1356/2015, Of 2 July, That Amending Annexes Ii, Iii And Vi Of The Real Decree 1030 / 2006 Of 15 September, Which Establishes The Portfolio Of Common Services Of The National Health System And The Procedure For Their Acts...

Original Language Title: Orden SSI/1356/2015, de 2 de julio, por la que se modifican los anexos II, III y VI del Real Decreto 1030/2006, de 15 de septiembre, por el que se establece la cartera de servicios comunes del Sistema Nacional de Salud y el procedimiento para su actua...

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Royal Decree 1030/2006 of 15 September establishing the portfolio of common services of the National Health System and the procedure for updating it establishes in its annexes the contents of each of the service portfolios, in development of the provisions of Law 16/2003, of 28 May, of cohesion and quality of the National Health System.

Article 6 of the royal decree states that, by order of the Ministry of Health, Social Services and Equality, prior to the agreement of the Interterritorial Council of the National Health System, the content of the different sections of the common service portfolio listed in its Annexes.

For its part, article 7 of the aforementioned royal decree states that the portfolio of common services of the National Health System contained in its annexes will be updated by order of the Ministry of Health, Social Services and Equality, with the agreement of the Interterritorial Council of the National Health System. Article 8 indicates that the portfolio update proposals will be agreed in the Commission on Benefits, Assurance and Financing and that the final approval of these proposals will be the responsibility of the Ministry of Health, Social Services and Equal agreement of the Interterritorial Council of the National Health System.

As a result of these forecasts, Order SCO3422/2007, of 21 November, for which the procedure for updating the portfolio of common services of the National Health System is developed, established the mechanism by which the service portfolio has been updated on different occasions by the corresponding orders.

Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its benefits, marked a substantial change in the common portfolio of services of the National Health System by modifying Article 8 of Law 16/2003 of 28 May, differentiating a basic common portfolio of care services, a supplementary common portfolio and a common portfolio of ancillary services. In the case of orthoprosthetic provision, surgical implants are part of the basic common portfolio of care services, while the rest of that provision is considered part of the supplementary common portfolio.

The Interterritorial Council of the National Health System created on February 29, 2012 a working group on the development of the basic common portfolio of health care services of the National Health System, with the objective of reviewing the said portfolio to identify and prioritize the capabilities whose content would need to be detailed, clarified or specified.

To address each of the prioritized areas of the basic common portfolio of care services, groups of experts were set up, in which professionals appointed by the autonomous communities and the Ministry of Health have participated. Health, Social Services and Equality, the scientific societies involved, as well as the Spanish Network of Health Technology Assessment Agencies and National Health System Benefits that provides information based on the evidence available scientific information on cases where there are doubts about effectiveness, security or efficiency.

In the case of implants, the completion and updating of the basic common portfolio of care services have been carried out within the surgical implant group, which is dependent on the Advisory Committee for the Orthoprosthetic provision, which has followed a similar scheme of work, creating expert groups in each of the eleven areas that configure the basic common portfolio of surgical implants.

As a result of the work of these expert groups, proposals for the completion and updating of the basic common portfolio of surgical implants have been developed, so that the content of many headings is broken down, specify the conditions of use of some implants, remove those that are considered obsolete and include those others that have demonstrated safety, efficacy and efficiency. The final proposals have been drawn up taking into account the criteria of the experts and the content of the evaluation reports provided by the Spanish Network of Agencies. These proposals were submitted to the Advisory Committee for the Orthoprosthetic Provision of 22 May 2014, which in turn raised the proposals to the Commission of Prstations, Assurance and Financing of 29 May 2014, which subsequently ratified the amendments made to the hearing procedure at the meeting of 25 November 2014.

This order seeks, on the one hand, to make the concretion and updating of Annex VI to Royal Decree 1030/2006 of 15 September, regarding surgical implants, effective, in order to clarify its scope, homogenizing and updating its indications in the light of the scientific evidence available, in order to help maintain cohesion in the National Health System and guarantee more effective and safe benefits and greater equity access for all citizens, avoiding differences between the benefits received by the users in each of the autonomous communities, thus achieving greater homogeneity and rationalisation of health expenditure.

This basic common portfolio of surgical implants, whose updating and implementation is set out in Annex I of this order, will be a first step that will make it possible to advance the establishment of maximum amounts of funding, according to the as provided for in Royal Decree 1506/2012 of 2 November 2012, which regulates the additional common portfolio for the orthoprosthetic provision of the National Health System and lays down the basis for the establishment of the maximum amounts of financing in the field of orthoprosthetic provision, as it is essential to have a more common portfolio a detailed grouping of products with similar characteristics to which similar amounts could be applied.

On the other hand, following the publication of Royal Decree 207/2010, of 26 February, establishing the conditions for the use of techniques, technologies and medical procedures and amending the Royal Decree 1207/2006, 20 October, which regulates the management of the Health Cohesion Fund, launched the use of the surgical treatment of facial lipoatrophy associated with HIV/AIDS. For three years the data on the results of the application of these treatments to patients has been collected following a protocol established for this purpose, reaching the conclusion that the treatments with autologous fat are safe and effective and require reinterventions less often than with the remaining materials. In addition, the Panel of Repair Implant Experts did not consider it appropriate, in the light of the available evidence, to include in the basic common portfolio of care services synthetic materials for this indication. All this led to the Commission of Prstations, Assurance and Financing of May 29, 2014 to propose the inclusion of the surgical treatment with autologous fat in the basic common portfolio of care services, for those patients with HIV-AIDS-associated lipoatrophy. However, it has been foreseen that in exceptional cases where fat cannot be used, the competent health authorities may expressly authorise their performance with other materials.

Finally, Royal Decree 1030/2006, of 15 September, points out in Article 7.5 that in order to carry out the updating of the common portfolio of services, the most appropriate evaluation procedure should be used in each case. to enable the effectiveness, efficiency, effectiveness, cost, safety or health utility of a technique, technology or procedure to be known, such as assessment reports, expert criteria, evaluation records, tutored uses, or others.

One of these evaluation procedures is the monitoring studies, which are regulated in this standard. Unlike tutelated use, they are intended as observational studies to assess techniques, technologies or procedures in the post-introduction phase in a portfolio because of their health need, but there is some uncertainty about their effectiveness in the Standard clinical practice or its efficiency, or are of foreseeable high economic or organizational impact or its behavior is unknown in specific population groups (by age, with comorbidities, etc.).

Therefore, it is necessary to regulate the mechanism by which the monitoring studies of techniques, technologies and procedures will be developed, so that they can obtain the necessary information to support future decisions on the updating of the common portfolio of services. In all this process, a relevant role is given to the Spanish Network of Health Technology Assessment Agencies and National Health System Pristations.

In this standard, the general conditions for the performance of the monitoring studies of techniques, technologies and procedures are regulated. In Annex II, those surgical implants that are introduced into the basic common portfolio of care services submitted to the monitoring study are collected, as more information is required on them, on a proposal from the Commission of Benefits, Assurance and Financing, in the light of the respective evaluation reports. Thus, once each of the studies has been completed, the necessary information will be available to assess their situation in the basic common portfolio of health care services of the National Health System, in accordance with the Order SCO3422/2007, dated 21 November.

Since the object of the monitoring studies are techniques, technologies or procedures included in the common portfolio of services, under the conditions set out in the relevant study, it is therefore appropriate to compensation for patient care in an autonomous community other than that of their residence through the Health Cohesion Fund.

In the future, by resolution of the head of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy, after agreement of the Interterritorial Council, they will be able to submit to study monitoring other techniques, technologies or procedures on which there are uncertainties.

This order has been reported by the Commission on Benefits, Assurance and Financing, the Advisory Committee of the Interterritorial Council of the National Health System, the Interterritorial Council of the National Health System and the Spanish Data Protection Agency. It has also been the subject of consultation by the Autonomous Communities, the National Institute of Health Management, the cities of Ceuta and Melilla and the mutual societies of officials, as well as the National Disability Council and have been heard. the various sectors concerned.

This order is made in use of the privileges conferred by the final provision of Royal Decree 1030/2006, dated September 15.

In its virtue, with the prior approval of the Minister of Finance and Public Administrations, and according to the State Council, I have:

Article 1. Object.

The object of this order is:

a) Concrete and update the content of the basic common portfolio of health care services of the National System of Health regulated by Royal Decree 1030/2006 of 15 September, establishing the portfolio of common services of the National Health System and the procedure for updating it, as regards the surgical treatments of the facial lipoatrophy associated with HIV/AIDS and the surgical implants listed in Annex I.

(b) Regular conditions for the performance of monitoring studies of techniques, technologies and procedures, as indicated in Annex II, the surgical implants submitted by this order to the study of monitoring.

Article 2. Modification of Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the National Health System and the procedure for updating it.

Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the National Health System and the procedure for updating it is amended as follows:

One. Paragraph 9.5.5 of Annex II is worded as follows:

"9.5.5 Dentary implants, except as provided for in the RP Implants division repairers of paragraph 6 of Annex VI."

Two. Paragraph 5.1.1 of Annex III is worded as follows:

" 5.1.1 Infectious and parasitic diseases: intestinal infectious diseases, tuberculosis, zoonotic bacterial diseases, other bacterial diseases, human immunodeficiency virus infection (including the surgical treatment of facial lipoatrophy associated with HIV-AIDS performed with autologous fat, although the competent health authorities may exceptionally authorise the performance of this treatment by means of synthetic materials in patients, such as haemophiliacs, in which, upon justification clinical, fat cannot be used), poliomyelitis and other viral diseases of the central nervous system not transmitted by arthropods, viral diseases accompanied by rash, viral diseases carried by arthropods, other diseases due to viruses and chlamydiae, rickettsiosis and other diseases carried by arthropods, syphilis and other venereal diseases, other spiroquetal diseases, mycoses, helminthiasis, other infectious and parasitic diseases and late effects of infectious and parasitic diseases. "

Three. The first subparagraph of paragraph 1.2 of Annex VI is worded as follows:

" 1.2 Surgical implants, external prostheses, wheelchairs, orthotheses and special orthoprostheses included in the common portfolio of orthoprosthetic provision are set out in paragraphs 6, 7, 8, 9 and 10 of this Annex, including, where appropriate, their conditions of use or the type of disability or clinical indication justifying their prescription. In paragraph 6, the divisions of the surgical implants coded with two digits and the groups coded with four digits are established, as well as the respective breakdowns reaching different levels of disaggregation that allow to group together. products with similar characteristics. In the case of paragraphs 7, 8, 9 and 10, the content of the common portfolio is determined by the groups (four digits) and sub-groups (six digits). The approved codes (9-digit coding) that are set out in those paragraphs shall be used only for the orthoprosthetic delivery information system. '

Four. A new paragraph 4.3 is added to Annex VI:

" 3. The health administrations responsible for the management of surgical implants shall establish the procedure for the acquisition of the same by the routes they consider most appropriate in each case in order to ensure their provision to patients with the maximum efficiency. "

Five. Paragraph 6 of Annex VI is replaced by the content of Annex I to that order.

Article 3. Concept, purpose and characteristics of the monitoring studies of techniques, technologies and procedures.

1. The studies on the monitoring of techniques, technologies and procedures (hereinafter 'monitoring studies') are observational and are part of the assessment mechanisms provided for in Article 7.5 of Royal Decree 1030/2006, 15 of September.

2. The monitoring studies are aimed at monitoring the results of a technique, technology or procedure introduced in the common portfolio of services of the National Health System due to their health need, so that obtain information that will enable them to assess their situation in the common portfolio of services. Its purpose is:

a) to determine the effectiveness and/or efficiency of the technique, technology or procedure, when there is some uncertainty about its behavior when performing it in the clinical practice in a generalized way or in population groups specific.

b) to obtain information on the results of the application of a technical, technological or predictable technical, technical or economic impact.

3. Each monitoring study shall be technically coordinated by an Evaluation Agency or Evaluation Unit (hereinafter the Evaluation Agency) of the Spanish Network for the Evaluation of Sanitary Technologies and Benefits of the National System of Health, including in the Annual Health Technology Assessment Plan. In order to carry out these tasks of technical coordination, the evaluation agency shall follow standard working procedures in the common quality methodological framework of the Spanish Network for the Evaluation of Health Technologies and System National of Health, in accordance with the provisions of the SSI/1833/2013 Order of 2 October, for which the Council of the Spanish Network of Health Technology Assessment Agencies and National Health System Assessment Agencies is established and regulated.

4. The study will be carried out in accordance with a protocol and will be carried out for a period of time proposed by the relevant evaluation agency, depending on the characteristics of the technique, technology or procedure, the information required obtain and from the periodicity of the follow-ups to be provided, which shall be ratified within the Commission of Benefits, Assurance and Financing before the start of the collection of information.

5. Only one technique, technology or procedure submitted for monitoring as part of the common portfolio of services in the centres proposed for the purpose by the Autonomous Communities may be carried out.

6. All patients who meet the inclusion criteria established in the protocol will have the right to access the techniques, technologies and procedures submitted to the monitoring study in the proposed centers for the realization of the study. To this end, the autonomous communities which have not proposed centres will facilitate the transfer of patients requiring the use of one of these techniques, technologies or procedures, similar to the rest of the common portfolio of services and ensuring the accessibility of patients with disabilities.

7. The monitoring studies shall be adapted to the requirements of the legislation applicable to them in the light of the technology, technology or procedure in question, so that, where the specific rules in force so provide, they shall be subject to the authorisation of the relevant ethics committee.

Article 4. Submission of a technique, technology or procedure to a monitoring study.

1. The application for a monitoring study shall be carried out by the Ministry of Health, Social Services and Equality, the health authorities of the Autonomous Communities or the mutual societies of officials or on a reasoned request. from third parties. The Commission of Prstations, Assurance and Financing, taking into account the suitability of the study to respond to the existing uncertainties about the technique, technology or procedure and its feasibility, will assess this request and will formulate, where appropriate, the proposal to carry out the monitoring study.

2. The Commission may carry out a prioritisation of the monitoring studies to be carried out, if it considers it necessary in the light of the requests received, taking into account the degree of uncertainty, its health need, its usefulness The target population and its cost.

3. The Ministry of Health, Social Services and Equality, in the light of this proposal, will give an opinion on the submission of a technique, technology or procedure to a monitoring study by means of a resolution of the head of the Directorate-General Primary Portfolio of Services of the National System of Health and Pharmacy.

4. The resolution shall lay down the technical requirements specific to each monitoring study, proposed by the Commission on Benefits, Assurance and Financing, and shall be determined, where appropriate, with the favourable report of the corresponding Autonomous Community, the Evaluation Agency which will be responsible for the technical coordination of the study.

Article 5. Protocol of the monitoring study.

1. Prior to the implementation of the monitoring study, a protocol for the selection of patients and data collection will be developed in such a way as to ensure safety, equity in access, including patients with disability, respect for bioethics and the achievement of results relevant to knowledge. In the event that patients are required to monitor the results of the technique, technology or procedure, they shall establish the periodicity of such monitoring and the data to be collected in each of them.

2. The protocol of the monitoring study shall consist of two parts:

(a) The first, which shall be drawn up by the Agency for the Technical Coordination of the Study on the basis of the information available, shall include the following:

1. The description of the technique, technology, or procedure.

2. Objective and justification for the study.

3. º Indications submitted to study.

4. Initial conditions of use of the technique, technology or procedure: material, human and training requirements for their correct use, requirements to gather the centres in which they are used, controls of quality, as well as requirements to be met by the facilities in which the technology is applied in accordance with the specific rules applicable to them.

Once informed of these initial conditions, and on the basis of these conditions, the autonomous communities will provisionally propose to the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality the centers of their respective areas that will participate in the consensus and elaboration of the second part of the protocol.

(b) The second part shall be drawn up by the Evaluation Agency with the participation of experts appointed by the scientific societies concerned and by the affected units of the Ministry of Health, Social Services and Equality. and of the centres provisionally proposed by the autonomous communities. In this way, the conditions of use of the technique, technology or procedure in the first part of the protocol will be ratified or modified and the design of the study will be established specifying the methodology to be followed and the size This is necessary to make the results of the study meaningful. It will contain the following sections:

1. The inclusion criteria and exclusion criteria for patients that specify the indications referred to in the service portfolio.

2. º variables that allow obtaining relevant information for the decision-making regarding patients and their own technique, technology or procedure, referring to their results, adverse effects and complications short, medium and long term, as well as variables defining subgroups of patients of particular interest, and those concerning the use of resources.

3. No follow-ups to be considered to be made to patients and periodicity of patients.

4. The procedure for sending and receiving data and monitoring compliance with the study protocol.

5. The definition of alarms that allow the detection of health-related problems that may arise during the study, as well as the communication mechanism of the same to the Ministry of Health, Services Social and Equality, which will transfer to the Commission of Benefits, Assurance and Financing and, where appropriate, the competent health authorities.

3. The protocol will be submitted to the Commission for Benefits, Assurance and Financing to ratify it.

Article 6. Conduct of the monitoring studies.

1. Once the Protocol has been ratified by the Commission on Benefits, Assurance and Financing, the Autonomous Communities will verify that the centres of their scope provisionally proposed have the conditions for the use of the technique, the technology or procedure laid down in that protocol, in line with the provisions of Article 5, and shall present the final proposal for participation in the study to the General Directorate of the Basic Portfolio of System Services National of Health and Pharmacy of the Ministry of Health, Social Services and Equality. The non-ratified centres will no longer be able to apply the technique, technology or procedure for the duration of the study.

2. In the event that a technique, technology or procedure submitted to a monitoring study is used for the attention of a pathology or the performance of a procedure for which it has designated centres, units or services of reference of the National Health System, the centers proposed by the respective autonomous communities to participate in the monitoring study must be previously designated in accordance with the provisions of Royal Decree 1302/2006 of 10 November 2006, laying down the bases of the procedure for the designation and accreditation of the National Health System centers, services and reference units.

3. The mutual societies of officials may determine, with the favourable report of the respective autonomous community, the centres in which the technique, technology or procedure in their management field will be carried out.

4. The centres which carry out the technique, technology or procedure submitted to the monitoring study undertake to follow the relevant protocol and to forward to the evaluation agency the data referred to in the protocol relating to their patients, in the form and time limits laid down therein. In case of failure to do so, the centre shall be excluded from the monitoring study, so it may not apply, from that time and for the duration of the study, the technique, technology or procedure as part of the common portfolio of services of the National Health System.

5. During the implementation of the monitoring study, the evaluation Agency shall carry out the following actions:

a) You will receive and process data from participating centers.

b) Immediately communicate to the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality the serious adverse effects detected in the application of the technique, technology or procedure submitted to a monitoring study, which could determine its cessation or modification, without prejudice to the fulfilment of the communication obligations required by the specific legislation in question each case.

c) Velara so that in the collection of data and in its transmission it is complied with the provisions of the Organic Law 15/1999, of December 13, of Protection of Data of Personal Character, and its regulations of development.

d) Constatara that the informed consent of the patients to whom the technique, technology or procedure is to be applied collects that the patient has been told that he is undergoing monitoring and that the patient authorizes the treatment and disposal of the data derived from the study and its subsequent follow-up, and complies with the provisions of Law 41/2002 of 14 November, basic regulation of the autonomy of the patient and of rights and obligations in relation to information and clinical documentation.

Article 7. Completion of the monitoring studies.

1. After the end of the study period, a technical report shall be drawn up by the evaluation Agency.

2. The technical report, which may be subject to external review by the Evaluation Agency, may include at least the following data:

a) Description of the technique, technology, or procedure.

b) Regulatory requirements for their application in Spain.

c) State prior to knowledge about its safety, efficacy and degree of implantation in Spain.

d) Results obtained from the monitoring study.

e) Conclusions on:

1. its effectiveness, effectiveness and efficiency and, where appropriate, its security;

2. its usefulness with respect to other existing alternatives;

3. the organizational repercussions of its introduction;

4. its economic impact, including estimating the costs of its use in the National Health System and,

5. º if applicable, recommendations on the most suitable conditions of use of the technique, technology or procedure.

3. In the case of monitoring studies for a duration of more than one year, in addition to the report cited, the evaluation agency shall draw up annually for the Commission on Benefits, Assurance and Financing a report on the evolution of the study, which will be presented in the first quarter of the following calendar year.

4. The technical report shall be submitted to the Commission for Benefits, Assurance and Financing to provide objective information on the technique, technology or procedure. Its analysis will enable the following procedure for updating the common portfolio of services of the National Health System to be implemented, as appropriate.

Article 8. Participation of the marketing companies.

In monitoring studies involving the use of a medical device:

1. The marketing companies may provide additional information which they consider to be able to contribute both to the preparation of the protocol and to the technical report to the relevant evaluation agency, through the Directorate-General of Basic Portfolio of Services of the National System of Health and Pharmacy.

2. The companies will provide the General Directorate of the Basic Portfolio of Services of the National Health System and Pharmacy with the information they request about the product that will contribute to solve the existing uncertainties that have generated the need to carry out a monitoring study, provided that it is not confidential information.

3. The General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy, with the participation of the autonomous communities with centers involved in the study, will agree with the marketing companies of the product to evaluate the economic conditions of the same during the period of study in the framework of shared risk management.

Additional disposition first. Specific technical requirements of the monitoring studies.

Within a maximum period of two months from the entry into force of this order, the following shall be established by resolution of the head of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy, specific technical requirements referred to in Article 4.4 of each of the monitoring studies listed in Annex II to this standard, on a proposal from the Commission on Benefits, Assurance and Financing.

Additional provision second. Complementary general aspects of the monitoring studies.

In the event that the Commission of Benefits, Assurance and Financing considers it appropriate, it may propose complementary general aspects to facilitate the implementation, development or follow-up of the studies of monitoring, which shall be effective by means of a resolution of the holder of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy.

Additional provision third. Adaptation of service portfolios.

The Autonomous Communities, the National Institute of Health Management and the mutual societies of officials shall adapt their respective portfolios of services to the provisions of this order within the maximum period of six months from their entry into

Additional provision fourth. No increase in public spending.

The measures included in this order will not be able to increase the amount of appropriations or salaries or other personnel costs for the public sector.

Final disposition first. Competence title.

This order is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 2 July 2015.-The Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.

ANNEX I

6. Surgical implants

6.1 Therapeutic surgical implants:

CA Implants.

CA 0 Implants for cardiostimulation. In case of use of products that are marketed as with protection for RM of 1.5 teslas, the resonance should only be performed when it is the only imaging study capable of helping the diagnosis and valuing that the benefit outweighs the risks. The resonance will be performed under strict safety measures (presence of qualified professionals, continuous monitoring, pulsioximetry, heart rate control, and cardiopulmonary resuscitation equipment).

CA 0 0 Marcasteps:

CA 0 0 0 SSI monocameral marcasteps with/without remote monitoring.

CA 0 0 1 SSIR monocameral marcasteps (frequently answered).

CA 0 0 1 0 SSIR monocameral marcasteps without remote monitoring.

CA 0 0 1 1 SSIR monocameral marcasteps with remote monitoring.

CA 0 0 2 VDD/VDDR bicameral marcasteps.

CA 0 0 2 0 bicameral VDD/VDDR Marcasteps without remote monitoring.

CA 0 0 2 1 VDD/VDDR bicameral Marcasteps with remote monitoring.

CA 0 0 3 DDD/DDDR bicameral marcasteps.

CA 0 0 3 0 bicameral DDD/DDDR Marcasteps without remote monitoring.

CA 0 0 3 1 bicameral DDD/DDDR Marcasteps with remote monitoring.

CA 0 0 4 Marcasteps with cardiac resynchronization therapy (with response in frequency).

CA 0 0 4 0 Marcasteps with cardiac resynchronization therapy without remote monitoring.

CA 0 0 4 1 Marcasteps with cardiac resynchronization therapy with remote monitoring.

CA 0 1 Implantable Automatic Defibrillator (DAI):

CA 0 1 0 single-ameral DAI with response in frequency.

CA 0 1 0 0 single-ameral DAI with frequency response without remote monitoring.

CA 0 1 0 1 single-ameral DAI with frequency response with remote monitoring.

CA 0 1 1 bicameral DAI with response in frequency.

CA 0 1 1 0 bicameral DAI with frequency response without remote monitoring.

CA 0 1 1 1 bicameral DAI with frequency response with remote monitoring.

CA 0 1 2 DAI with heart resynchronization therapy with response in frequency.

CA 0 1 2 0 DAI with heart resynchronization therapy with response in frequency without remote monitoring

CA 0 1 2 1 DAI with heart resynchronization therapy with frequency response with remote monitoring

CA 0 1 3 subcutaneous defibrillator. Its use is contraindicated in patients with symptomatic bradycardia, or ventricular tachycardia that can be terminated with anti-tachycardia (ATP) stimulation. When a permanent stimulation is required, it does not represent a valid alternative to the transvenous system.

CA 0 2 Electrode:

CA 0 2 0 Electrode for endocardial stimulation.

CA 0 2 1 Electrode for coronary sinus stimulation.

CA 0 2 2 Electrode for epicardial stimulation.

CA 0 2 3 Electrode for defibrillation.

CA 1 Cardiological Implants:

CA 1 0 Valve.

CA 1 0 0 Mechanical valve.

CA 1 0 1 Xenologous biological valve (autologs are provided for in paragraph 5.2.16 of transplants in Annex III)

CA 1 0 2 Non-sutured biological valve, for patients with symptomatic severe aortic stenosis, > 75 years, with a life expectancy of more than one year, operable, with high surgical risk due to comorbidities or conditions anatomic that disadvises the implantation of conventional prostheses, valued by a multidisciplinary committee

CA 1 0 2 0 Autoexpandable.

CA 1 0 2 1 Expansible with ball.

CA 1 0 3 Transcatheter aortic valve, for patients with symptomatic severe aortic stenosis, evaluated by a multidisciplinary committee, in centers that have a cardiac surgery service and a written protocol of selection of patients

CA 1 0 3 0 Autoexpandable.

CA 1 0 3 1 Expansible with ball.

CA 1 0 4 Transcatheter pulmonary valve, for patients with congenital heart disease for whom no other therapeutic alternative exists, performed in National Health System reference services.

CA 1 1 Ring for valvuloplasty.

CA 1 1 0 Ring for rigid valvuloplasty.

CA 1 1 1 Ring for flexible valvuloplasty.

CA 1 1 2 Ring for semi-rigid valvuloplasty.

CA 1 2 Valvular Pipeline.

CA 1 2 0 Valvulated duct with mechanical valve.

CA 1 2 1 Valvulated pipeline with xenologist biological valve (autologas are provided for in paragraph 5.2.16 of transplants in Annex III).

CA 1 3 Replaced pericardium.

CA 1 3 0 Substitute of synthetic pericardium.

CA 1 3 1 Substitute of the biological xenologist pericardium (autologists are referred to in paragraph 5.2.16 of transplants in Annex III).

CA 1 4 Cardiac and vascular occlusion device.

CA 1 4 0 Interatrial Communication Closure System.

CA 1 4 1 percutaneous device for foramen oval closure, for secondary prevention of cryptogenic stroke.

CA 1 4 2 System for Interventricular Communication Closure.

CA 1 4 3 Arductus ductus closure system.

CA 1 4 4 Closing device (occlusal) of the left atrial ear LAA, for patients with atrial fibrillation, with the presence of other risk factors for added cerebrovascular accident and contraindication or intolerance to oral anticoagulation therapy or to patients who are to undergo percutaneous intervention of the mitral valve and also have atrial fibrillation, high risk of stroke and contraindication or intolerance to oral anticoagulation therapy, submitted to a monitoring study.

CA 1 5 Ventricular Assist Device in the following indications:

-as a bridge to transplantation (temporary or short-term) when the patient has a compromised or refractory hemodynamic situation to drug treatment,

-as a bridge to recovery in patients with acute heart failure who do not respond to conventional treatment and who have the possibility of myocardial recovery, such as cardiogenic shock and severe acute myocarditis and

-as target therapy (permanent or long-term) for patients who are not candidates for transplantation, with left ventricular ejection fraction ≤ 25%, and with a NYHA class IIIB/IV and peak VO2 <14 ml/kg/min despite the optimal inotropic treatment, in accordance with the protocols of each competent health administration

CA 1 6 Mitral valve percutaneous repair system:

CA 1 6 0 Mitral valve percutaneous repair system by clip, for patients with severe symptomatic mitral insufficiency (≥ 3 +) refractory to optimal medical treatment, with a life expectancy of at least one year, in that a multidisciplinary team has determined an excessive risk to be intervened by open surgery and a comorbidity that does not threaten the benefit expected by the reduction of mitral insufficiency, and meet anatomical criteria appropriate (the primary jet is caused by bad coaptation of the media segments -A2 and P2-of the mitral valves), submitted to the monitoring study.

Digestive implants.

Oesophageal CD 0.

CD 0 0 Stent metal.

CD 0 0 0 Recovered (partially or fully).

CD 0 0 1 Uncoated.

CD 0 0 1 0 Valvular.

CD 0 0 1 1 Not valvular.

CD 0 1 Stent of plastic.

CD 0 2 Stent biodegradable, for benign pathology subjected to monitoring study.

CD 1 Enterals.

CD 1 0 Stent duodenal.

CD 1 0 0 Metal.

CD 1 0 0 0 Recovered.

CD 1 0 0 1 Uncoated.

CD 1 1 Stent colon/rectum.

CD 1 1 0 Metal.

CD 1 0 0 0 Recovered.

CD 1 0 0 1 Uncoated.

CD 2 Biliopancreatics.

CD 2 0 Stent metal.

CD 2 0 0 Recovered (partially or fully).

CD 2 0 1 Uncoated.

CD 2 1 Stent plastic.

CD 3 Recto-Annals.

CD 3 0 artificial anal sphincter, as a second-choice procedure in the treatment of faecal incontinence when other alternative, medical or surgical procedures have failed or become inapplicable and practice for sufficiently experienced teams

CD 3 1 Implant injection for fecal incontinence.

CD 4 Other abs.

CD 4 0 Stent for percutaneous portosystemic shunt (TIPS).

CD 4 1 adjustable gastric band, for adult patients with morbid obesity (BMI greater than 40 Kg/m2 or BMI greater than 35 Kg/m2 with significant associated comorbidity) in which they have failed other more conservative weight reduction alternatives, such as diet, exercise, and behavioral modification programs

GU Genitourinary Implants.

GU 0 Urological.

GU 0 0 Renoureteral.

GU 0 0 0 Ureteral stent.

GU 0 0 0 0 Mono J.

GU 0 0 0 1 Double J.

GU 0 0 0 1 0 Short term.

GU 0 0 0 1 1 Medium term.

GU 0 0 0 1 2 Long Term.

GU 0 0 0 1 3 Special.

GU 0 0 1 Subcutaneous ureteral derivative.

GU 0 1 Prostatic.

GU 0 1 0 Prostatic stent, for symptomatology associated with urinary flow obstruction derived from benign prostatic hyperplasia.

GU 0 2 For urinary incontinence.

GU 0 2 0 Fixing band, for stress incontinence when conservative or pharmacological treatment has failed.

GU 0 2 0 Women.

GU 0 2 0 0 0 Mediouthral.

GU 0 2 0 0 0 0 Retro/suprapubica.

GU 0 2 0 0 0 1 Transover.

GU 0 2 0 0 1 Single incision.

GU 0 2 0 0 2 Long-term adjustable, for relapsing effort incontinencies, sphintery deficits, and/or fixed urethals.

GU 0 2 0 1 Male.

GU 0 2 0 1 0 Four arms.

GU 0 2 0 1 1 Two arms.

GU 0 2 0 1 2 Long-term adjustable, for mild male incontinence by partial sphinterian injury.

GU 0 2 0 1 2 0 With mechanical compression.

GU 0 2 0 1 2 1 With hydraulic compression.

GU 0 2 1 Artificial urinal sphincter.

GU 0 3 Implant for injection for primary reflux.

GU 1 Genitales.

GU 1 0 Peneano, for patients who do not respond to drug treatments for erectile dysfunction, valuing their age, life expectancy, and their ability to use them.

GU 1 0 0 Inactive or malleable.

GU 1 0 1 Active.

GU 1 0 1 0 Two components.

GU 1 0 1 1 Three components.

GU 1 1 Witness.

GU 1 2 Implant for pelvic organ prolapse, in centers with proven experience in their use.

GU 1 2 0 Abdominal.

GU 1 2 0 0 Malla partially absorbable.

GU 1 2 0 1 Malla permanent.

GU 1 2 1 Vaginal, as a second-line therapeutic alternative for those cases where conventional surgery fails in patients with recurrent prolapse or with comorbidities that make it unfeasible to perform procedures. more invasive or more invasive laparoscopic and/or open time

GU 1 2 1 0 Previous.

GU 1 2 1 1 Later.

GU 1 2 2 Malla recortable.

GU 1 3 Implant for Hysterical Airway Obstruction.

NQ Neurological Implants.

NQ 0 Bypass systems, including their reservoirs.

NQ 0 0 Programmable.

NQ 0 0 0 Impregnated.

NQ 0 0 1 Not impregnated.

NQ 0 1 Unprogrammable.

NQ 0 1 0 Slit or diaphragm.

NQ 0 1 1 Type ball in pussy.

NQ 0 1 1 0 Impregnated.

NQ 0 1 1 1 Not impregnated

NQ 0 2 Anti-gravitational device.

NQ 0 3 Intraventricular reservation.

NQ 0 3 0 Plastic Camera.

NQ 0 3 1 Titanium Camera.

NQ 0 4 Cateter.

NQ 0 4 0 Ventricular Catheter.

NQ 0 4 1 Peritoneal, lumbar, or cardiac catheter.

NQ 1 Neurostimulators, for patients whose symptoms cannot be adequately controlled with other alternative, medical or surgical procedures, in accordance with the protocols of each competent health administration.

NQ 1 0 Generator.

NQ 1 0 0 Generator for medullary stimulation, for chronic refractory pain to conventional medical and surgical treatments.

NQ 1 0 0 0 Recargable.

NQ 1 0 0 0 0 Double channel.

NQ 1 0 0 0 1 Of four channels.

NQ 1 0 0 1 Not rechargeable.

NQ 1 0 0 1 0 Of a channel.

NQ 1 0 0 1 1 Dual Channel.

NQ 1 0 1 Generator for sacral stimulation, for urinary incontinence and for fecal incontinence.

NQ 1 0 1 0 Of a channel.

NQ 1 0 1 1 Dual Channel.

NQ 1 0 2 Generator for brain stimulation, for primary dystonia, tremor, Parkinson's, intractable pain, and epilepsy.

NQ 1 0 2 0 Recargable.

NQ 1 0 2 1 Not rechargeable.

NQ 1 0 2 1 0 Of a channel.

NQ 1 0 2 1 1 Dual Channel.

NQ 1 0 3 Generator for peripheral stimulation.

NQ 1 0 3 0 The vagus nerve, for epilepsy.

NQ 1 0 3 1 The phrenic nerve, for diaphragmatic stimulation in prolonged artificial ventilation in patients suffering from respiratory muscle paralysis (RMP) or central alveolar hypoventilation (CAH).

NQ 1 0 3 2 The root dorsal ganglion, for chronic refractory pain to conventional medical and surgical treatments.

NQ 1 0 3 3 From other locations, for the treatment of chronic refractory pain to conventional medical and surgical treatments.

NQ 1 1 Electrode.

NQ 1 1 0 For medullary stimulation.

NQ 1 1 0 1 For percutaneous implantation.

NQ 1 1 0 1 0 Four poles.

NQ 1 1 0 1 1 Of Eight Poles

N Q 1 1 0 1 2 Of 16 poles.

NQ 1 1 0 2 For surgical implant.

NQ 1 1 0 2 0 Four poles.

NQ 1 1 0 2 1 Of eight poles.

NQ 1 1 0 2 2 Of 16 poles.

NQ 1 1 0 2 3 Of thirty-two poles.

NQ 1 1 1 For sacral stimulation.

NQ 1 1 1 0 Percutaneous four-pole.

NQ 1 1 2 For brain stimulation.

NQ 1 1 2 0 Four poles.

NQ 1 1 2 1 Of eight poles.

NQ 1 1 3 For peripheral stimulation.

NQ 1 1 3 0 The vagus nerve.

NQ 1 1 3 1 The phrenic nerve.

NQ 1 1 3 2 The root ganglion of the root.

NQ 1 1 3 3 Of other locations.

NQ 1 2 Extension, adapter, and other accessories.

NQ 1 2 0 Extension and adapter.

NQ 1 2 0 0 For brain electrode.

NQ 1 2 0 1 For medullary and sacrum electrode.

NQ 1 2 0 2 For peripheral and subcutaneous electrode.

NQ 1 2 1 Fixing system.

NQ 1 2 1 0 For brain electrode.

NQ 1 2 1 1 For medullary electrode.

NQ 1 2 1 2 For peripheral, subcutaneous, and sacral electrode.

OF ophthalmological implants.

OF 0 Intraocular Lents (LIOs) for the correction of aphachia, excluding multifocal posterior chamber intraocular lenses.

OF 0 0 previous camera LIO.

OF 0 0 0 previous camera LIO with angular support.

OF 0 0 1 previous camera LIO with iridian support.

OF 0 1 Monofocal rear camera LIO.

OF 0 1 0 rear-mounted single-room camera LIO.

OF 0 1 1 rear-mounted monofocal camera LIO.

OF 0 1 0 1 0 silicone folding monofocal rear camera.

OF 0 1 1 1 1 LIO of Spherical Acrylic Folding Monofocal.

OF 0 1 1 2 LIO of posterior chamber monofocal folding acrylic asferic acrylic.

OF 0 1 1 2 0 Standard.

OF 0 1 1 2 1 Pre-filled standard.

OF 0 1 1 2 2 Microincision (≤ 2 mm).

OF 0 1 1 2 3 Pre-filled microincision (≤ 2 mm).

OF 0 1 1 3 LIO of posterior chamber monofocal folding acrylic aspherical acrylic.

OF 0 1 1 3 0 Standard.

OF 0 1 1 3 1 Pre-filled standard.

OF 0 1 1 3 2 Microincision (≤ 2 mm).

OF 0 1 1 3 3 Pre-filled microincision (≤ 2 mm).

OF 0 2 monofocal posterior chamber LIO, for correction of afaquia in special situations.

OF 0 2 0 0 standard toric monofocal, for corneal astigmatisms between 3 and 5 dioptrias, prior to topographic study.

OF 0 2 1 personalized toric monofocal, for corneal astigmatisms of more than 5 dioptrias acquired after trauma or corneal surgery, prior to topographic study.

OF 0 2 2 MONOfocal LIO with iridianios optics and segments

OF 1 Other devices to be implanted with intraocular lenses.

OF 1 0 Capsular tension ring.

OF 1 0 0 Standard capsular voltage ring.

OF 1 0 1 Capsular tension ring with anchor system.

OF 1 1 iridian segment (aniridia).

OF 1 1 0 Partial iridian segment.

OF 1 1 1 Full Iridiculous Segment.

OF 2 Lents for special situations.

OF 2 0 Faquica Lente for keratocono.

OF 2 0 0 Faquica Lente for Spherical Keratocone.

OF 2 0 1 Faquica Lente for Twist Keratocone.

OF 2 1 Postkeratoplasty Lente Faquica.

OF 2 1 0 Spherical Postkeratoplasty.

OF 2 1 1 Toric Postkeratoplasty.

OF 2 2 Special Lente designed for sulcus implant.

OF 3 Devices for glaucoma surgery.

OF 3 0 Implant for filtering surgery.

OF 3 1 Drain Device.

OF 3 1 0 Previous camera communication-subconjunctival space.

OF 3 1 0 0 Valvular (restrictive flow mechanisms).

OF 3 1 0 1 Do not valve.

OF 3 1 1 Communication previous chamber-suprachoroid space, when conventional medical and surgical treatments have failed.

OF 3 1 2 Communication previous camera-Schlem channel.

OF 4 Enucleation and evisceration protesis.

OF 4 0 Enucleation and biointegrable evisceration protein.

OF 4 1 Non-biointegrable enucleation and evisceration protein.

OF 5 Palpebral Implants.

OF 5 0 Gold Palpebral Implant.

OF 5 1 Platinum palpebral implant, for patients allergic to gold or with pre-gold rejection.

OF 5 2 Synthetic Palpebral Implant (PTFE).

OF 6 Other ophthalmologic implants.

OF 6 0 Tear Gas Implant.

OF 6 0 0 Drainage tube in conjunctive-dachrio surgery.

OF 6 1 Implant for vitreoretinian surgery.

OF 6 2 Keratoprostheses of synthetic material.

OF 6 3 Intrastromal Ring, for the correction of keratoconus and other corneal ectasias.

OR ENT implants.

OR 0 Average Ear Prothesis.

OR 0 0 Ocular chain reconstruction protesis.

OR 0 0 0 Partial replacement (PORP).

OR 0 0 0 0 Metal.

OR 0 0 0 1 Hydroxyapatite.

OR 0 0 0 2 Plastics.

OR 0 0 0 3 Mixta.

OR 0 0 1 Total replacement (TORP).

OR 0 0 1 0 Titanium.

OR 0 0 1 1 Hydroxiapatite.

OR 0 0 1 2 Plastics.

OR 0 1 Stapetetomia/stapetotomy.

OR 0 1 0 Metal.

OR 0 1 1 Plastics.

OR 0 1 2 Mixta.

OR 0 2 Trans-Timanic Drillage.

OR 0 2 0 Silicone.

OR 0 2 1 fluoroplastic.

OR 1 Active hearing implants, in accordance with the protocols of each competent health administration (including the renewal of the external components that are part of the common external prosthesis portfolio, in the conditions to be determined by the competent health administration in the management of the benefit.

OR 1 0 Bone conduction implant.

OR 1 0 0 Percutaneous.

OR 1 0 1 Transcutaneous, assessing appropriate bone thickness in the case of children.

OR 1 1 Medium-ear active implant.

OR 1 2 Cochlear implant, including bilateral implantation after individualized assessment in children and adults. The following situations shall be considered in particular:

-patients with postinfectious hypoacusia (such as post-meningitis or poscytomegalovirus) or associated with other disabilities (blindness, multisensory deficits, or Usher Syndrome)

-patients with poor results after the first implant who may gain second from the second by presenting other alterations (malformations of the inner ear with low unilateral functional outcome, behavioral disorders hypoacusia), or a pathology that may interfere with the results of the first cochlear implant (Pendred syndrome or other hereditary syndromes associated with bilateral progressive loss).

OR 1 3 Brain trunk implant.

OR 2 Phonatory Prothesis.

OR 2 0 Phonatory Prothesis.

OR 3 laryngeal protesis.

OR 3 0 larynx implant.

OR 3 0 0 Prothesis for Medialization Thyroplasty.

OR 3 0 0 0 Hydroxyapatite.

OR 3 0 0 1 Silicone.

OT Implantable Devices for Drug Administration.

OT 0 Implantable infusion pump, for the treatment of spasticity of different etiologies and the treatment of pain when conventional forms of drug delivery have failed.

OT 0 0 Programmable.

OT 0 1 Unprogrammable.

OT 0 2 Cateter for intrathecal infusion pump.

OT 1 Other drug delivery devices.

OT 1 0 Vascular subcutaneous reservation.

OT 1 0 0 Conventional flow.

OT 1 0 0 0 Plastic Camera.

OT 1 0 0 0 0 Standard.

OT 1 0 0 0 1 Low profile, brachial or pediatric.

OT 1 0 0 0 2 Double-camera.

OT 1 0 0 0 3 Blood.

OT 1 0 0 1 Titanium Camera.

OT 1 0 0 1 0 Standard.

OT 1 0 0 1 1 Low profile, brachial or pediatric.

OT 1 0 0 1 2 Double-camera.

OT 1 0 0 1 3 Blood.

OT 1 0 1 High flow (compatible with high pressure injection).

OT 1 0 1 0 Plastic camera.

OT 1 0 1 0 0 Standard.

OT 1 0 1 0 1 Low profile, brachial or pediatric.

OT 1 0 1 0 2 Double-camera.

OT 1 0 1 0 3 Blood.

OT 1 0 1 1 Titanium Camera.

OT 1 0 1 1 0 Standard.

OT 1 0 1 1 1 Low profile, brachial or pediatric.

OT 1 0 1 1 2 Double-camera.

OT 1 0 1 1 3 Blood.

OT 1 1 Non-vascular subcutaneous reserve (the intraventricular reservoir is included in the neurological implants section).

OT 1 1 0 Epidural.

OT 1 1 0 0 Plastic Camera.

OT 1 1 0 1 Titanium Camera.

OT 1 1 1 Peritoneal or pleural.

OT 1 1 1 0 Plastic Camera.

OT 1 1 1 1 Titanium Camera.

OT 1 1 2 Intratecal.

OT 1 1 2 0 Plastic Camera.

OT 1 1 2 1 Titanium Camera.

OT 1 2 Drug-making Particle.

OT 1 3 Long Term Drug Administration Cateter.

OT 1 3 0 Tunelized.

OT 1 3 1 Not tunneled.

RE Implants of the respiratory apparatus.

RE 0 tracheal and bronchial protesis.

RE 0 0 Tube tracheal in T.

RE 0 1 trache-bronchial protein.

RE 0 1 0 Metal coated.

RE 0 1 1 Non-metallic.

RE 0 1 1 0 Silicone.

RE 0 1 1 1 Plastic.

RE 0 1 2 Mixta.

RE 0 2 Endobronchial Device.

RE 0 2 0 endobronchial valve, for patients with severe COPD showing complete interlobular cisura or absence of collateral ventilation and in the case of patients with persistent air leakage, under study monitoring.

RE 0 2 1 Device for lung volume reduction by pulmonary retraction.

RP Implants repairers.

RP 0 Breast protein (Not included when used in cosmetic surgery interventions that do not relate to accident, disease, or congenital malformation).

RP 0 0 Round breast protein.

RP 0 0 0 Silicone Gel.

RP 0 0 0 0 Lisa.

RP 0 0 0 1 Textured.

RP 0 0 1 Saline Suero.

RP 0 0 1 0 Lisa.

RP 0 0 1 1 Textured.

RP 0 1 anatomical breast protein.

RP 0 1 0 Silicone Gel.

RP 0 1 0 0 Textured.

RP 0 1 1 Saline Suero.

RP 0 1 1 0 Textured.

RP 0 2 Adjustable Breast Protein.

RP 0 2 0 Silicone gel filled round and saline serum.

RP 0 2 0 0 Lisa.

RP 0 2 0 1 Textured.

RP 0 2 1 Saline serum, textured, and remote injection port.

RP 0 3 Tailored silicone protein, for secondary chest defects to congenital malformations, trauma or disease, which cannot be repaired with autologous tissue.

RP 0 4 Prothesis with polyurethane surface.

RP 1 Skin expanders (Not included when used in cosmetic surgery interventions that do not have a relationship with accident, disease, or congenital malformation).

RP 1 0 Breast Expander.

RP 1 0 0 With valve built in.

RP 1 0 0 0 Redondo.

RP 1 0 0 1 Anatomic.

RP 1 0 1 With remote valve and optional injection port removal.

RP 1 1 tissue expander.

RP 2 Implants for skull-facial surgery (Not included when used in cosmetic surgery interventions that do not have a relationship with accident, disease or congenital malformation).

RP 2 0 Face Implant.

RP 2 0 0 Malar, submalar, facial and mandibular.

RP 2 0 0 0 Titanium device.

RP 2 0 0 1 Reabsorbable device, for paediatric patients.

RP 2 0 1 Dental implant, for patients with cancer processes affecting the oral cavity involving loss of teeth directly related to the pathology or its treatment, and patients with congenital malformations who have an anodontic (cleft, lymphatic malformations, ectodermic dysplasia, craniofacial syndromes, etc.).

RP 2 0 2 Orbiter.

RP 2 0 2 0 Titanium device.

RP 2 0 2 1 Reabsorbable device, for pediatric patients and in small defects.

RP 2 0 3 Exiting.

RP 2 0 3 0 Device for minimally invasive surgery (stent).

RP 2 0 4 Nasal.

RP 2 0 4 0 Osteo-integrated titanium implant system for nasal prosthesis fixation.

RP 2 0 5 Headphone.

RP 2 0 5 0 Osteo-Integrated Titanium Implant System for Atrial Prosthesis Fixation.

RP 2 1 Temporary-mandibular joint protein.

RP 2 1 0 Total.

RP 2 2 Prothesis for the reconstruction of mastoideas.

RP 2 3 cranial plasty.

RP 2 3 0 For bone replacement.

RP 2 3 0 0 Synthetic.

RP 2 3 0 1 Metal.

RP 2 3 0 2 Xenologist.

RP 2 3 0 3 Reabsorbable closure system, for paediatric patients.

RP 2 3 1 To replace the dura frame.

RP 2 3 1 0 Synthetic.

RP 2 3 1 1 Biological xenologist.

RP 3 Malds of eventrations and hernias (including different sizes and mesh densities).

RP 3 0 Malla of abdominal wall hernias repair and eventrations.

RP 3 0 0 For open and/or laparoscopic laparoscopic surgery.

RP 3 0 0 0 Malla flat.

RP 3 0 0 1 Flat flat Malla.

RP 3 0 0 2 Malla stopper or similar.

RP 3 0 0 3 Self-adhesive Malla.

RP 3 0 0 4 Self-expandable Malla.

RP 3 0 1 For intraperitoneal open and/or laparoscopic surgery.

RP 3 0 1 0 Flat Malla.

RP 3 0 1 0 0 Partially absorbable.

RP 3 0 1 0 1 Not absorbable.

RP 3 0 1 0 1 0 Double-layer Malla.

RP 3 0 1 0 1 1 Malla of a layer.

RP 3 0 1 1 Self-expandable Malla.

RP 3 1 Malla of herniary repair in contaminated environments, open abdomen, and abdominal compartment syndrome.

RP 3 1 0 Biologic Malla.

RP 3 1 1 Reabsorbable synthetic Malla.

RP 3 2 Other Hernias Repair Malla.

RP 3 2 0 Toracica.

RP 3 2 1 Hiatal.

RP 3 2 1 0 Absorbible.

RP 3 2 1 1 Permanent.

RP 3 2 2 Parastomal.

RP 3 2 2 0 Absorbible.

RP 3 2 2 1 Permanent.

RP 4 Muscle replacements, for patients who require replacement prostheses in congenital absences of the pectoral muscle or Poland Syndrome.

RP 5 Dermic Substitutes.

RP 5 0 Dermal Regeneration Lamina.

RP 6 Support biological Laminas.

RP 6 0 Cellular Dermal Matrix.

RP 6 1 Non-dermal Array.

Osteoarticular implantes.

TR 0 Hip protein.

TR 0 0 Primary.

TR 0 0 0 Partial.

TR 0 0 0 0 Cemented.

TR 0 0 0 0 0 Monoblock.

TR 0 0 0 0 1 Bipolar.

TR 0 0 0 0 2 Unipolar.

TR 0 0 0 1 Not cemented.

TR 0 0 0 1 0 Bipolar.

TR 0 0 0 1 1 Unipolar.

TR 0 0 1 Total.

TR 0 0 1 0 Cemented.

TR 0 0 1 0 0 Pair metal-polyethylene.

TR 0 0 1 0 1 Pair ceramic-polyethylene.

TR 0 0 1 1 Not cemented.

TR 0 0 1 1 0 Pair metal-polyethylene.

TR 0 0 1 1 1 Ceramic-ceramic pair.

TR 0 0 1 1 2 Pair ceramic-polyethylene.

TR 0 0 1 2 Hybrid.

TR 0 0 1 2 0 Pair metal-polyethylene.

TR 0 0 1 2 1 Ceramic-ceramic pair.

TR 0 0 1 2 2 Pair ceramic-polyethylene.

TR 0 1 Review.

TR 0 1 0 Femoral component.

TR 0 1 1 Acetabular component.

TR 0 1 2 Pair of friction.

TR 0 1 3 Supplement/Support.

TR 0 1 4 Spacer.

TR 0 2 Tumoral or special.

TR 0 2 0 Modular Megaprosthesis.

TR 0 2 1 pelvis protein.

TR 0 2 2 Custom Prothesis.

TR 1 Knee protein.

TR 1 0 Primary.

TR 1 0 0 Unicompartimental (unicondilea or femoropatelar).

TR 1 0 0 0 Cemented.

TR 1 0 0 1 Not cemented.

TR 1 0 1 Total.

TR 1 0 1 0 Cemented.

TR 1 0 1 0 0 Post-partition (PS).

TR 1 0 1 0 1 Cross Conservation (CR).

TR 1 0 1 0 2 High-congruent polyethylene.

TR 1 0 1 0 3 Polyethylene all tibial component.

TR 1 0 1 1 Not cemented.

TR 1 0 1 1 0 Post-partition (PS).

TR 1 0 1 1 1 Cross Conservation (CR).

TR 1 0 1 1 2 polyethylene insert.

TR 1 0 1 2 Hybrid.

TR 1 0 1 2 0 Post-partition (PS).

TR 1 0 1 2 1 Cross Conservation (CR).

TR 1 0 1 2 2 polyethylene insert.

TR 1 0 1 2 3 Polyethylene all tibial component.

TR 1 1 Review.

TR 1 1 0 Femoral component.

TR 1 1 1 Tibial Component.

TR 1 1 2 polyethylene insert.

TR 1 1 3 Supplement/Support.

TR 1 1 4 Rotulian Component.

TR 1 1 5 Spacer.

TR 1 1 6 Charnela Prothesis.

TR 1 2 Tumoral or special.

TR 1 2 0 Modular Megaprosthesis.

TR 1 2 1 Custom Prothesis.

TR 2 Prothesis of ankle and foot.

TR 2 0 Ankle protesis.

TR 2 1 Foot Prothesis.

TR 2 1 0 Outstanding Prothesis.

TR 2 1 0 0 Metatarsofalangica, for patients with arthritis or disabling arthrosis of the first metatarsophalangeal joint (hallux rigidus).

TR 2 1 0 1 Interphalangica, for total or partial reconstructions of foot after severe trauma.

TR 3 Column Prothesis.

TR 3 0 Of vertebral body.

TR 3 0 0 Cervical.

TR 3 0 1 Toracica.

TR 3 0 2 Lumbar.

TR 3 1 Intervertebral.

TR 3 1 0 Discal protein, for patients who do not respond to conservative medical treatment.

TR 3 1 0 0 Cervical.

TR 3 1 0 1 Lumbar, for patients with chronic low back pain associated with disc degeneration between levels L4-S1.

TR 3 1 1 Intersomatic spacer.

TR 3 1 1 0 Cervical.

TR 3 1 1 0 0 No fixation.

TR 3 1 1 0 1 With fixation.

TR 3 1 1 1 Lumbar.

TR 3 1 1 1 0 Later PLIF.

TR 3 1 1 1 1 1 Posterolateral TLIF.

TR 3 1 1 1 2 Lateral XLIF/DLIF.

TR 3 1 1 1 3 Previous ALIF.

TR 3 1 1 1 3 0 No fixation.

TR 3 1 1 1 3 1 With fixation.

TR 3 1 2 An interspinous device, for the treatment of symptomatic lumbar spinal stenosis in patients who do not respond to conservative treatment and not candidates for conventional surgical treatment.

TR 3 2 vertebral fixation.

TR 3 2 0 Cervical.

TR 3 2 0 0 Occipito-cervical.

TR 3 2 0 1 Posterior Cervical.

TR 3 2 0 2 Anterior Cervical.

TR 3 2 1 Toracica.

TR 3 2 1 0 Previous.

TR 3 2 1 1 Later.

TR 3 2 2 Lumbar.

TR 3 2 2 0 Previous.

TR 3 2 2 1 Later.

TR 3 2 2 1 0 Fixed.

TR 3 2 2 1 1 Dynamics.

TR 3 2 3 Sacroiliac, for patients with pain in the sacroiliac region, refractory to any conventional therapy (pharmacological, physioterapic, rehabilitation, denervation).

TR 3 2 4 Device for correction of spinal deformities (scoliosis, kyphosis).

TR 3 3 Device for cyphoplasty and vertebroplasty, for patients with compression osteoporotic fracture.

TR 3 3 0 Vertebroplasty.

TR 3 3 1 Cyphoplasty.

TR 3 3 2 Statplasty, for patients with one or more vertebral body osteoporotic fractures located in the T10-L5 segment that are accompanied by refractory pain to medical treatment at the fracture level, assessing the benefits and risks of their performance.

TR 4 Shoulder Protesis.

TR 4 0 Primary.

TR 4 0 0 Partial.

TR 4 0 0 0 Cemented.

TR 4 0 0 1 Not cemented.

TR 4 0 1 Total.

TR 4 0 1 0 Cemented.

TR 5 1 0 0 0 Standard.

TR 5 1 0 0 1 Inverted.

TR 4 0 1 1 Not cemented.

TR 5 1 0 1 0 Standard.

TR 5 1 0 1 1 Inverted.

TR 4 0 1 2 Hybrid.

TR 4 0 2 Coating.

TR 4 1 Review.

TR 4 1 0 Humeral component.

TR 4 1 1 Glenoid component.

TR 4 1 2 Supplement/Support.

TR 4 1 3 Spacer.

TR 4 2 Tumoral or special.

TR 4 2 0 Modular Megaprosthesis.

TR 4 2 1 Custom Prothesis.

TR 5 Elbow Protein.

TR 5 0 Primary.

TR 5 0 0 Partial (Hemiarthroplasty).

TR 5 0 1 Total.

TR 5 0 2 Radio Head Protesis.

TR 5 1 Review.

TR 5 2 Tumoral.

TR 5 2 0 Modular Megaprosthesis.

TR 5 2 1 Custom Prothesis.

TR 6 Hand and wrist protesis.

TR 6 0 Doll protein.

TR 6 0 0 Partial (distal radiocubital).

TR 6 0 1 Total.

TR 6 1 Hand Protesis.

TR 6 1 0 Carp Hueso.

TR 6 1 1 Trapecometacarpiana.

TR 6 1 2 Metacarpofalangica.

TR 6 1 3 Interphalangica.

TR 7 Other osteoarticular implants.

TR 7 0 Ligaments and tendons.

TR 7 1 Osteosynthesis.

TR 7 2 Synthetic bone replacement.

Vascular Implants.

VA 0 Vascular substitutes.

VA 0 0 Synthetic.

VA 0 0 0 Bifurcated tubular.

VA 0 0 0 0 PTFE.

VA 0 0 0 0 0 Pared fine.

VA 0 0 0 0 0 0 Anillado.

VA 0 0 0 0 0 1 Not anillated.

VA 0 0 0 0 1 Stop standard.

VA 0 0 0 0 1 0 Anillado.

VA 0 0 0 0 1 1 No ring.

VA 0 0 0 1 Polyester.

VA 0 0 0 1 0 Standard.

VA 0 0 0 1 0 0 Anillado.

VA 0 0 0 1 0 1 Not ringed.

VA 0 0 0 1 1 Impregnated.

VA 0 0 0 1 1 0 Anillado.

VA 0 0 0 1 1 1 Not ringed.

VA 0 0 1 Straight tubular.

VA 0 0 1 0 cylindrical/asymmetric PTFE.

VA 0 0 1 0 0 Pared fine.

VA 0 0 1 0 0 0 Anillado.

VA 0 0 1 0 0 1 Not ringed.

VA 0 0 1 0 1 Pared standard.

VA 0 0 1 0 1 0 Anillado.

VA 0 0 1 0 1 1 Not ringed.

VA 0 0 1 0 1 2 Impregnated.

VA 0 0 1 1 Polyester.

VA 0 0 1 1 0 Standard.

VA 0 0 1 1 0 0 Anillado.

VA 0 0 1 1 0 1 Not ringed.

VA 0 0 1 1 1 Impregnated.

VA 0 0 1 1 1 0 Anillado.

VA 0 0 1 1 1 1 Not ringed.

VA 0 0 2 Patch.

VA 0 0 2 0 PTFE.

VA 0 0 2 1 Polyester.

VA 0 1 Biologic xenologist (autologists are referred to in paragraph 5.2.16 of transplants in Annex III).

VA 0 1 0 Tubular.

VA 0 1 1 Patch.

VA 0 2 Vascular access.

VA 0 2 0 Synthetic.

VA 0 2 0 0 Tubular protein for hemodialysis (PTFE).

VA 0 2 0 1 Permanent Cateter with Tunelization.

VA 0 2 1 Biologic xenologist (autologists are referred to in paragraph 5.2.16 of transplants in Annex III).

VA 1 endovascular implants (according to the protocols of each competent health administration).

VA 1 0 Brain Endovascular.

V A 1 0 1 Conventional Stent.

V To 1 0 1 0 Autoexpandable.

V A 1 0 1 1 Ball Expansible

V A 1 0 2 Stent flow wrapper.

VA 1 1 Coronary Endovascular.

VA 1 1 0 Stent not impregnated.

VA 1 1 0 0 Simple.

VA 1 1 0 1 Bifurcado.

VA 1 1 1 Stent impregnated.

VA 1 1 1 0 With antiproliferative drug.

VA 1 1 1 0 0 Simple.

VA 1 1 1 0 1 Bifurcado.

VA 1 1 1 1 With non-antiproliferative drug.

VA 1 1 2 Stent bioreabsorbable, for treatment of ischemic heart disease in patients with novo coronary artery lesions in the native coronary artery and disease of one or two vessels, outside the acute phase of myocardial infarction, without contraindication regarding double antiplatelet therapy and with no coronary trunk or ortho-coronary artery bypass involvement.

VA 1 1 3 Stent covered with mesh.

VA 1 2 aortic endovascular.

VA 1 2 0 Toracic.

VA 1 2 0 0 Stent not covered.

VA 1 2 0 1 Stent covered.

VA 1 2 0 1 0 Cylindrical/conical Recto.

VA 1 2 0 1 1 With branches.

VA 1 2 0 1 2 Fendais.

VA 1 2 1 Abdominal.

VA 1 2 1 0 Stent not covered.

VA 1 2 1 1 Stent covered.

VA 1 2 1 1 0 Cylindrical/conical Recto.

VA 1 2 1 1 1 Bifurcado.

VA 1 2 1 1 2 With branches.

VA 1 2 1 1 3 Fendais.

Custom-covered stents will require prior authorization from the Health Service.

VA 1 3 Carotid Endovascular.

VA 1 3 0 Stent expandable with ball.

VA 1 3 0 0 Covered.

VA 1 3 0 1 Not covered.

VA 1 3 1 Stent self-expandable.

VA 1 3 1 0 Cylindrical/conical Recto.

VA 1 3 1 1 Open sheet.

VA 1 4 peripheral endovascular.

VA 1 4 0 Stent covered.

VA 1 4 0 0 Expansible with ball.

VA 1 4 0 0 0 Impregnated.

VA 1 4 0 0 1 Not impregnated.

VA 1 4 0 1 Autoexpandable.

VA 1 4 0 1 0 Impregnated.

VA 1 4 0 1 1 Not impregnated.

VA 1 4 1 Stent not covered.

VA 1 4 1 0 Expansible with ball.

VA 1 4 1 0 0 Impregnated.

VA 1 4 1 0 1 Not impregnated.

VA 1 4 1 1 Self-expandable.

VA 1 4 1 1 0 Impregnated.

VA 1 4 1 1 1 Not impregnated.

VA 1 4 2 Stent bioreabsorbable, for patients with peripheral arterial disease with non-complex, non-large and non-calcified lesions.

VA 1 5 Filter vena cava.

VA 2 Vascular closure/occlusion systems.

VA 2 0 Hemostatic device.

VA 2 0 0 With suture.

VA 2 0 1 No suture.

VA 2 1 Vascular tape.

VA 2 1 0 Covered.

VA 2 1 1 Not covered.

VA 2 2 Embolization Material.

VA 2 2 0 Particula.

VA 2 2 0 0 Calibrated.

VA 2 2 0 1 Not calibrated.

VA 2 2 0 2 For embolization and drug release.

VA 2 2 1 Liquid.

V A 2 2 1 0 endovascular-use liquid agent

V A 2 2 1 1 Sclerosing agent for percutaneous use.

VA 2 2 2 Device.

VA 2 2 2 0 Pushing Spiral.

VA 2 2 2 1 Controlled Release Spiral.

VA 2 2 2 1 0 Mechanics.

VA 2 2 2 1 1 Non-mechanical.

VA 2 2 2 2 Non-spiral Controlled-Release Device

6.2 Diagnostic Surgical Implants:

DC Diagnostic Heart Implants.

DC 0 Holters implantable with/without remote monitoring, for the assessment of patients with syncopes or other rare significant problems in which arrhythmic cause is suspected and in which an initial extensive evaluation did not demonstrate the cause or did not lead to a specific treatment

ANNEX II

Techniques, technologies and procedures submitted to monitoring study

Biodegradable esophageal stent for benign pathology.

endobronchial valve for patients with persistent air leakage.

The percutaneous repair system of the mitral valve by clip, for patients with severe symptomatic mitral insufficiency (≥ 3 +) refractory to optimal medical treatment, with a life expectancy of at least one year, in which a Multidisciplinary team has determined an excessive risk to be intervened by open surgery and a comorbidity that does not threaten the benefit expected by the reduction of mitral insufficiency, and meet appropriate anatomical criteria (the Primary jet is caused by bad coaptation of the media segments -A2 and P2-of the mitral valves).

Closing device (occlusal) of the left atrial ear, for patients with atrial fibrillation, with the presence of other risk factors for added cerebrovascular accident and contraindication or intolerance to the oral anticoagulation therapy or for patients who will be subjected to a percutaneous intervention of the mitral valve and also have atrial fibrillation, high risk of stroke and contraindication or intolerance to therapy oral anticoagulation.