belgiquelex.be - Carrefour Bank of Legislation

27 AVRIL 2005. - Health Care Budget Control Act and various health provisions (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART I^er. - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
PART II. - Amendments to the Health Care Insurance Act and Coordinated Benefits Act on 14 July 1994 excluding those related to drug policy
CHAPTER 1^er. - Patient protection measures
Art. 2. Section VII of Chapter I^er Part III of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, replaced by the Act of 24 December 2002 and amended by the Act of 8 April 2003, including section 25, is replaced by the following provisions:
"Section VII. - Special Solidarity Fund.
Sub-section 1^re. - General
Art. 25. It is established within the Health Care Service, a Special Solidarity Fund funded by a deduction from the resources referred to in Article 191 which is set, for each calendar year, by a Royal Decree deliberated in the Council of Ministers.
The College of Physicians and Directors decides to provide interventions to the beneficiaries referred to in sections 32 and 33 within the financial resources of the Fund.
The Special Solidarity Fund provides only one intervention when the conditions set out in this section are met and when the beneficiaries have asserted their rights under Belgian, foreign, supranational or an individual or collective contract. The Fund only provides interventions in the health benefits costs for which, in the concrete case, no intervention is provided under the Belgian health insurance regulations or under the legal provisions of a foreign mandatory insurance scheme.
Not supported by the Special Solidarity Fund:
1° The personal quotas referred to in sections 37 and 37bis and the supplements on the prices and fees established pursuant to the regulation of compulsory health care insurance;
2° The supplements referred to in section 90 of the Hospitals Act, coordinated on August 7, 1987, and the cost of comfort.
Sub-section II. - Intervention for care delivered in Belgium
Art. 25 bis. As part of the care provided in Belgium, the College of Physicians and Directors can provide interventions in the cost of health benefits for rare indications.
In addition, these benefits must meet each of the following conditions:
(a) the benefit is expensive;
(b) the benefit has a scientific value and a widely recognized effectiveness by authoritative medical authorities and the experimental stage is exceeded;
(c) the benefit is used for the treatment of a condition that affects the vital functions of the recipient;
(d) there is no medical-social alternative to diagnosis or therapy in the context of compulsory health care insurance;
(e) benefits are prescribed by a medical practitioner, specialized in the treatment of the affected condition, authorized to practise medicine in Belgium.
The fact that the claimed benefit is not refunded under compulsory health care insurance or at least for the indication justifying the application while it may be for other indications, is not in itself a rare feature.
Art. 25ter. § 1^er. The College of Physicians and Directors may provide an intervention in the cost of health benefits to recipients who are affected by a rare condition.
This benefit must meet each of the following conditions:
(a) the benefit is expensive;
(b) the benefit is designated in a manner motivated by authoritative medical authorities as a specific physiopathological approach to rare disease;
(c) the performance is intended to affect the vital functions of the individual who constitutes a direct and specific consequence of the rare condition;
(d) there is no therapeutic alternative to compulsory health care insurance;
(e) the benefit is prescribed by a medical practitioner, specialized in the treatment of the affected condition, authorized to practise medicine in Belgium.
As part of the Special Solidarity Fund, it cannot be derogated from the decisions of the College of Physicians for Orphaned Medicines referred to in Article 2 of the Royal Decree of 8 July 2004 on the reimbursement of orphan drugs.
§ 2. The College of Physicians/Directors may provide an intervention in the costs of recipients with a rare condition that requires continuous and complex care.
An intervention in the cost of such care may be granted if care meets each of the following conditions:
(a) care is in their entirety expensive;
(b) care is intended to treat an impairment of the vital functions of the individual who is a direct and specific consequence of the rare condition;
(c) there is no therapeutic alternative to compulsory health care insurance;
(d) Complex care is prescribed as part of a treatment plan by a medical practitioner, specialized in the treatment of the affected condition, authorized to practise medicine in Belgium.
The College of Physicians and Directors notes what benefits meet the above conditions.
Art. 25quater. For a limited period of time, the College of Physicians and Directors may provide interventions in the cost of medical devices and benefits, excluding drugs, which are innovative medical techniques.
These medical devices and benefits must meet each of the following conditions:
(a) medical devices and benefits are expensive;
(b) medical devices and benefits are rare;
(c) medical devices and benefits are designated in a manner motivated by authoritative medical authorities as the method indicated for the treatment of an impairment of the recipient's vital functions and have exceeded the experimental stage;
(d) after a cost/benefit assessment, benefits have a significant and demonstrated surplus value;
(e) benefits are prescribed by a medical practitioner, specialized in the treatment of the affected condition and authorized to practise medicine in Belgium;
(f) the Competent Technical Council has received an application for an assessment of the medical surplus-value and/or intervention of compulsory insurance in the cost of such benefits.
Upon a proposal from the College of Physicians and Directors, the Insurance Committee shall draw up a limiting list of medical benefits and devices, referred to in paragraph 1^er for which for a limited period of a maximum of one year an intervention can be granted. This period may be renewed once and the Committee must motivate this decision.
Art. 25quinquies. § 1^er. The College of Physicians and Directors grants, under the conditions set out in this article, full additional costs related to the medical treatment of chronic sick children under the age of 19, as soon as these costs reach a sum of 650 euros.
This intervention remains due for all calendar years in which the additional costs reach an amount of 650 euros as well as during the next calendar year in which this amount is not reached.
This intervention is again acquired for the calendar year in which the additional costs taken into consideration reach 650 euros.
A chronic sick child means a child suffering from one of the following conditions:
- cancer;
- kidney failure in chronic treatment by peritoneal dialysis or hemodialysis;
- another life threatening disease, which requires continuous treatment of at least six months or repetitive treatment of the same duration.
§ 2. The additional costs relate to health benefits that meet each of the following conditions:
(a) benefits have a scientific value and are highly recognized by authoritative medical authorities;
(b) there is no acceptable alternative from a medico-social perspective, in terms of therapy or prevention, as part of compulsory health care insurance;
(c) the benefits are prescribed by a medical practitioner, specialized in the treatment of the affected condition, who coordinates the treatment or by the attending physician if these benefits are included in the treatment plan referred to in § 3, and who is authorized to practise medicine in Belgium.
§ 3. The benefits that result in additional costs are prescribed by the medical specialist referred to in § 2 (c) as part of a treatment plan.
The College of Physicians and Directors notes what benefits meet the above conditions.
§ 4. By derogation from Article 25, paragraph 4, may be considered as additional costs, the personal share which is not taken into account in the totalization of the moderator tickets made within the framework of the maximum to be charged, as well as the margin of issue referred to in the national agreement between the implant suppliers and the insurance organizations, and the margin of security referred to in Article 35, § 4, 2° and 3° and to the Royal Health Insurance Agreement
Section III. - Intervention in care provided abroad
Art. 25sexies. The Special Solidarity Fund may cover the medical expenses of the beneficiaries in cases worthy of interest for health benefits provided abroad for which the physician advises has given his or her consent in accordance with the applicable Belgian, international or supranational regulations, as well as the travel and stay expenses of the beneficiary and, if applicable, of the person accompanying him or her for the intended benefits.
The health services provided abroad must be prescribed prior to their completion by a specialist doctor, specialized in the treatment of the affected condition and authorized to practise medicine in Belgium.
Sub-section IV. - Procedures
Art. 25s. § 1^er. The King may, after the advice of the Insurance Committee, determine the procedures for the application and award of the intervention.
The request for the intervention of the insurance in the cost of the benefits referred to in subsections II and III is introduced by the beneficiary of the health care insurance to the physician-advisor of his or her insurer, by registered letter to the position, or by any other means to determine with certainty the date of introduction of the application.
However, the recipient is not required to apply for intervention in the additional costs referred to in section 25quinquies. For these additional costs, the insurer to which the individual is affiliated or registered, as well as other stakeholders in the care, may apply for intervention on the basis of the elements in their possession and after agreement of the individual.
The application must include at least:
1° a sheet of information, the model of which is established by the Insurance Committee, on the proposal of the College of Physicians-Directors, and submitted by the physician-advisor of the insurance body to the College of Physicians-Directors, within thirty days of the day on which the request was introduced by the recipient. Any request for additional information sent directly to the recipient suspends the 30-day period. The same is true when the recipient is informed that additional information has been requested;
2° a prescription, the model of which may be established by the Insurance Committee on the proposal of the College of Physicians-Directors, established by a physician, along with a circumstantial medical report that contains all information to conclude whether the requested benefit meets the conditions set out in subsections II and III;
3° a detailed invoice or a detailed estimate in the case of an application for principle established by the care provider(s);
4° the statement on the honour of which the model is established by the Insurance Committee, on the proposal of the College of Physicians and Directors in which the recipient:
- certifies, with regard to the benefits for which he requests an intervention, that he has exhausted his rights under Belgian or foreign legislation and that he cannot claim rights under an individual or collective contract;
- discloses the amount to which it may, if any, assert its rights under the aforementioned contract;
- Determines whether or not the reimbursements provided by health care insurance under the Special Solidarity Fund will be paid.
§ 2. The consulting physician referred to in section 153 does not send the application to the College of Physicians/Directors if it relates to:
- costs of lodging, stay or travel of the beneficiary or the accompanying person during the admission of a beneficiary to a Belgian hospital;
- personal supplements or interventions for benefits provided in accordance with any regulations that include the conditions of intervention of health care insurance in certain benefits, including for care done abroad. However, if the application can be considered under section 25quinquies, it must be forwarded to the College of Physicians and Directors;
- health care and/or travel and living expenses for a beneficiary who receives care abroad and for whom the medical consultant of the insurance agency has not given an authorization;
- a benefit made more than three years before the application.
Art. 25octies. The King may determine the conditions under which the decision-making power of the College of Physicians and Directors may be exercised by one or more physicians, members of that College. It sets out the criteria for the amount, billing and payment of the intervention that the College referred to above takes into consideration when granting this decision authority. This decision-making power cannot in any case be exercised exclusively by physicians occupied by the insurance organization to which the interested beneficiary is affiliated or registered. If the College decides on a quote for the intervention requested by the Special Fund for Solidarity, the College gives an agreement in principle on the basis of which the insurer concerned may intervene. In this case, the insurer submits a quarterly summary of the performance of the amounts paid as a result of the College's decisions.
At the session at which the application is processed, the College of Physicians and Directors may request an opinion regarding, among other things, the indication and/or the indicative price, to authorized scientific bodies, to the official bodies within INAMI, to the Federal Public Service Public Health, Safety of the Food Chain and Environment or to the Federal Centre for Health Care Expertise. In the absence of one or more notices within two months of the application made to a proceeding referred to by the College of Physicians and Directors, the College shall decide on the request for intervention. The College makes requests for advice on the same file at the same session.
Art. 25 nuns. If the College of Physicians/Directors immediately decides the intervention on the basis of an invoice, the insurer shall pay the amount awarded to the beneficiary or care provider within 15 working days of the receipt of the notification of the decision of the College of Physicians-Directors.
If the College issues an agreement in principle and the consulting physician of the insurer agency determines the amount allocated in the manner provided by the College of Physicians and Directors after checking the invoice, the insurer pays the amount to the beneficiary or care provider within 20 working days of receipt of the invoice.
No intervention by the Special Solidarity Fund is due for an amount granted to which the recipient is in fact liable only in the event of a favourable decision.
Sub-section V. - Activity Report
Art. 25decies. Each year, the College of Physicians and Directors prepares a report containing an inventory of decisions for the Insurance Committee and the General Council. This report may also contain proposals or suggestions for the improvement or adaptation of health care insurance. These proposals or suggestions are forwarded to the competent technical councils responsible for the preparation of proposals to amend the nomenclature referred to in section 35. "
Art. 3. The provisions of Article 2 shall apply for benefits that are realized from 1^er April 2005, with the exception of the provisions of section 25quinquies that are applicable for benefits realized from 1^er January 2004.
Art. 4. Section 34 of the Act, as amended by the Acts of 22 December 1995, 22 February 1998, 25 January 1999, 24 December 1999, 12 August 2000, 10 August 2001, 22 August 2002, 24 December 2002, 5 August 2003, 22 December 2003, 9 July 2004, and 27 December 2004, is supplemented as follows:
"25° home care for people with non-congenital brain injury and requiring heavy chronic care. "
Art. 5. In Article 35, § 1^er, paragraph 6, of the Act, as amended by the Acts of 20 December 1995, 22 February 1998, 24 December 1999, 10 August 2001, 22 August 2002, 5 August 2003, 22 December 2003 and 9 July 2004, in paragraph 6, the words "the benefits referred to in section 34, 14°, are replaced by the words "the benefits referred to in section 34, 14° and 25°".
Art. 6. In Article 37, § 20, of the same law, inserted by the law of 22 February 1998, the words "the benefits referred to in Article 34, 14°" are replaced by the words "the benefits referred to in Article 34, 14° and 25°".
CHAPTER II. - Accountability measures
Art. 7. Article 36bis, § 1^erof the same law, inserted by the law of 10 December 1997 and amended by the law of 14 January 2002, the third paragraph shall be supplemented as follows:
"- Respect for rules or recommendations in relation to the rational prescription of medications and specialized benefits established by the National Council for the Promotion of Quality or, where applicable, by the Commission for the Reimbursement of Drugs, after notification by the Institute to the committees of conventions and agreements concerned, with effect from the first day of the second month following the said notification. "
Art. 8. In section 141, § 3, of the same law, inserted by the law of 24 December 2002, the following amendments are made:
1° in paragraph 2, the words "or at the initiative of the profile commissions" are inserted between the words "insurers" and "the";
2° in paragraph 3, the words "the Service does" are replaced by the words "the Service or profile commissions do".
Art. 9. In Article 56ter, § 5, paragraph 1^er(, from the same law, inserted by the law of 22 August 2002 and amended by the law of 24 December 2002, the following sentence is inserted after the first sentence: "For admissions from 1^er January 2005, this provision is valid as soon as actual expenditures for all admissions to a hospital referred to in § 1^er exceed the reference expenditures calculated in accordance with § 4."
Art. 10. In the same law, an article 56quater is inserted as follows:
"Art. 56quater. By derogation from the provisions of Article 56ter, a package to be fixed by the King may be applied in accordance with the conditions to be fixed by him, by admission to the hospital of a beneficiary. This package includes groups of benefits to be designated by him, referred to in Article 56ter, §§ 8 and 10 as long as they relate to the APR-DRG groups designated by him, referred to in §§ 9 and 10 of the same article.
The King shall designate the benefit groups and APR-GDP groups referred to in paragraph 1^er, after notice of the multi-party structure referred to in section 153 of the Act of 29 April 1996, bringing social provisions, issued within a time limit fixed by the Minister. If there is no notice within this period, the notice will be deemed given.
Art. 11. Article 64 of the Act, amended by the laws of 22 February 1998 and 25 January 1999, the current text of which forms a § 1^erthe following modifications are made:
1° § 1^er, paragraph 2, is replaced by the following paragraphs: "From the date of entry into force of the Health Care Budget Act... and the provision of various health care provisions, it is prohibited to charge the patient with benefits that do not meet the conditions referred to in paragraph 1^er.
Offences to this provision are found by inspectors or controllers referred to in section 146. Minutes of the offence shall be communicated to the Minister who has the fixing of the budget of the financial means of the hospitals in his or her powers, with a view to the application of section 107, § 1^erof the Hospitals Act, coordinated on 7 August 1987. ";
2° the article is supplemented by §§ 2, 3, 4 and 5 as follows:
§ 2. If a medical device, as indicated and described by the King, is installed or operated in a hospital, without an authorization referred to in section 40, without approval as a medical-technical service referred to in section 44, or in violation of the maximum number or programming criteria referred to in section 41, or 44ter, of the Hospitals Act, coordinated on August 7, 1987, the packages and fees designated by the King, due
Reduction of fees or packages due, referred to in paragraph 1^er, also applies in cases where a hospital service, hospital function, hospital section, medical service or care program is operated without approval, referred to in section 68, of the aforementioned coordinated law, or in violation of the programming criteria or the maximum number as referred to in section 23, 44bis of 44ter.
In the event of an offence referred to in paragraph 1, or 2, in the context of an association of hospitals, as referred to in the above-mentioned coordinated law, the reduction of packages and fees shall be effected for the benefits established by the King pursuant to paragraph 1^er, which were carried out in the various hospitals that are part of the association, whether within the framework of the association or not.
The application of paragraphs 1^er and 2 cannot be taken into account in any way. Minutes setting out the offence, referred to in paragraphs 1^er and 2, which is established by the inspector or controller referred to in section 146, shall be communicated to the Minister who has the fixing of the budget of the financial means of the hospitals in his or her responsibilities for the purposes of section 107, § 1^er the Hospitals Act, coordinated on 7 August 1987 and the application of paragraphs 1^er and 2 of this article.
§ 3. The provisions of § 2 are also applicable to doctors who are active in a practice, outside the site of a hospital or association of hospitals, where devices are installed or operated in violation, articles 40, 41, 44 or 44bis or 44ter of the law on hospitals coordinated on 7 August 1987 or of their enforcement orders.
The reduction of fees or packages is in relation to fees or packages due to the physicians concerned, even if the benefits were performed outside the place of practice.
§ 4. In the event that the same offence referred to in §§ 2 and 3 is found a second time after at least thirty days in a report by a physician-inspector or controller referred to in this section, the officer of the Medical Evaluation and Control Service may proceed, following a decision of the officer of the Medical Evaluation and Control Service, referred to as the "direct officer", to the seals of the device or location where the hospital service is operated, the hospital service, the medical department, the medical section,
The operator of the hospital or medical office may request the officer to lift the seals by registered mail provided that the necessary measures have been taken to avoid the repetition or continuation of the offences referred to in paragraphs 2 and 3.
In the event that the application meets the condition referred to in paragraph 2, the officer orders the removal of the seals, which is served on the applicant by registered mail within ten working days after receipt of the request for a lift. This recommended mail mentions the date and time that the seals will be lifted, which must take place within three working days of the shipment in question.
In the event that the application does not meet the requirement under paragraph 2, the ruling officer's decision to refuse the release of the seals shall be served within ten working days after the request is received.
In the event that the same offence is repeated within three years after a seal is lifted, the request for a lift is not admissible on the first three months of the sealing.
§ 5. The Federal Nuclear Control Agency established by the Act of 15 April 1994 on the protection of the population and the environment from the hazards resulting from ionizing radiation and related to the Federal Nuclear Control Agency and the Institute shall exchange the necessary data for the exercise of their respective control missions in a manner to be defined by the King.
Art. 12. The provisions of Article 11, 2° come into force on 1^er July 2005.
Art. 13. In the same law, an article 190bis is inserted as follows:
"Art. 190bis. Without derogating from the competence of the existing bodies in terms of quality assessment, control and promotion, the ministers who have public health and social affairs in their responsibilities designate a delegate to the Institute who is responsible for full time, to organize the coordination of the leadership of the various initiatives and their evaluation, which are developed in the field of the promotion of the quality of health care, the promotion of good medical practices and the good use of health.
This delegate regularly reports to ministers on initiatives that are being taken to promote quality in the exercise of medical practice, in particular with a view to reducing variability in the exercise of medical practices and their results.
Ministers may entrust this delegate with any mission to ensure coordination between the initiatives taken by the Institute, the relevant Federal Public Services, the Federal Health Care Expertise Centre, the Multi-stakeholder Structure in relation to hospital policy and the Intermutualist Agency.
The delegate is appointed by the King for a period of 6 years, renewable.
The status of this delegate is established by the King. Its treatment and operating costs are borne by the Institute's budget.
This delegate is assisted in the exercise of his mission by a steering committee whose composition and mode of operation are fixed by the King, by deliberate decree in Council of Ministers.
CHAPTER III. - Financial arrangements
Art. 14. Section 199 of the Act, replaced by the Royal Decree of 12 August 1994 and amended by the Acts of 20 December 1995, 25 January 1999, 24 December 1999 and 22 December 2003, are amended as follows:
1° § 2, paragraph 7, is replaced by the following paragraph: "From 1^er January 2004, the special reserve fund shall be financed by the portion of the bonus referred to in Article 198, § 2, and/or by 80 p.c. of the financial interests referred to in Article 191, paragraph 1^er 10°bis, on the money fund and/or the balance of financial products and financial expenses, referred to in section 191, paragraph 1^er, 10°ter, paragraph 2, diminished of the annual interest products referred to in § 3, paragraph 4, and/or by a licensee's contribution and/or by a payment from the insurer's own means. ";
2° to § 3, paragraph 4, the words "until December 31, 2003 included" are deleted.
Art. 15. Section 14 produces its effects on 1^er January 2004.
CHAPTER IV. - Miscellaneous provisions
Art. 16. In articles 12, 10°, paragraph 2, second sentence, 16, § 1^er, 5°, paragraph 3, first sentence, 80, 8°, paragraph 2, second sentence, 80bis, 4°, second sentence, inserted by the law of 22 February 1998, 141, § 1^er, 17°, paragraph 2, second sentence, and 161, § 1^er, 10°, paragraph 2, second sentence of the same law, the words "in its next session" are deleted.
Art. 17. § 1^er. For the purposes of this article, is considered to be an implantable medical device, any device intended to be fully implanted in the human body or to replace an epithelial surface or the surface of the eye, through surgery and to remain in place after the operation.
It is also considered an implantable device, any device intended to be partially introduced into the human body by surgical procedure and intended to remain in place after the operation for at least 30 days.
§ 2. The Minister who has the Social Affairs in his or her responsibilities, shall, after consultation with the Minister of Economic Affairs and on the proposal of the Technical Council of Implants, set out in the Compulsory Health Care Insurance Act and Coordinated Allowances Act on July 14, 1994, the maximum amount that may be required by the manufacturer for implantable medical devices placed on the market, and their accessories to the extent that they are issued following a coordinated charge or benefits for which an intervention is provided,
Without prejudice to the above-mentioned laws, an amount greater than the maximum amount determined under paragraph 1^er, cannot be supported by the patient for the aforementioned implantable medical devices.
The King may extend the scope of this section to other medical devices that he or she designates as long as they are delivered within the framework of one or more benefits for which an intervention under the above-mentioned Act, coordinated on 14 July 1994, or as a result of a budget hospitalization of the financial means covered by the Hospitals Act, coordinated on 7 August 1987.
The Minister must notify the producer of the decision referred to in paragraph 1^erwithin 180 days of application.
The King shall determine the terms and procedure for applying this article. "
Art. 18. Article 17 comes into force on the date fixed by the King.
PART III. - Hospital provisions
Section 1^re. - Amendments to the Hospitals Act
Art. 19. In section 23 of the Hospitals Act coordinated on August 7, 1987, as amended by the Act of December 30, 1988, the following amendments are made:
1° to paragraph 1^er, the words "and the imperatives of sound management, as well as forecasts regarding the evolution of health facilities that without belonging directly to the hospital sector, are likely to influence these programming criteria" are replaced by the words "inside a territory to be fixed".
2° the second paragraph is deleted.
Art. 20. In section 24 of the Act, the words "of geographical distribution and equitable distribution referred to in section 23, paragraph 2" are replaced by the words "and geographical distribution".
Art. 21. Section 41 of the Act, replaced by the Act of January 14, 2002, is supplemented by the following paragraph: "The programming criteria referred to in paragraph 2 are those referred to in sections 23 and 24. "
Art. 22. Section 44ter of the Act, inserted by the Act of 21 December 1994, and amended by the Act of 14 January 2002, the current text of which will form paragraph 1^er, a paragraph 2 is added as follows:
"The programming criteria referred to in paragraph 1^er are those referred to in articles 23 and 24. "
Art. 23. Section 69 of the Act, as amended by the Acts of 21 December 1994 and 14 January 2002, and the current text of which will form paragraph 1^er is supplemented by the following paragraphs:
"Hopital associations referred to in paragraph 1^er, 3° can be exploited by a legal person. Only legal persons who operate hospitals that are part of the association referred to in paragraph 2, as well as natural or legal persons proposed by the legal person concerned, may be a member or associate of the legal person who operates the association.
Art. 24. In section 75bis of the Act, inserted by the Act of 14 January 2002, the following amendments are made:
1° the article is supplemented by a paragraph 3 which reads as follows:
"The approvals and authorizations referred to in paragraph 1^er and 2 are not applicable to the Minister and the Institute referred to in paragraph 1^eronly from the date of receipt of the communication by the Minister. ";
2° the article is supplemented by a paragraph 4, which reads as follows:
"The King may, until April 30, 2007, provide for exceptions to paragraph 3 for appliances, hospital services, hospital functions, hospital sections, medical and medical services and medical-technical services and care programs that he designates."
Art. 25. In the same law, a chapter Illbis, which reads as follows, is inserted in Title III:
"Chapter IIbis. Programming and aggregation in case of operation at several sites
Art. 76sexies. § 1^er. A hospital service, a hospital function, a hospital section, a care program, a heavy medical device or a medical or medical-technical service may be operated on several sites of the same hospital, a hospital association, other than the exceptions determined by the King.
§ 2. If a hospital service, a hospital function, a hospital section, a care program, a heavy medical device or a medical or medical-technical service is operated on several sites of the same hospital or hospital association, it must, at the different sites, separately:
(1) be approved, as referred to in sections 44 or 71 or subject to prior approval as referred to in section 40;
2° meet all accreditation standards, as referred to in sections 44, 68 or 69;
3° with respect to the application of the programming or the maximum number rules, as referred to in sections 23, 41, 44 bis, 44ter or 76quinquies, to be taken into account as a hospital service, hospital function, hospital section, care program, heavy medical equipment or a separate medical or medical service.
§ 3. The King may set derogations from the application of this article for hospital services, hospital functions, hospital sections, care programs, heavy medical equipment and medical and medical services that he designates."
Art. 26. Article 25 comes into force on the day of the publication of this Act to the Belgian Monitor, with the exception of §§ 2 and 3 of Article 76sexies, which produce their effects on 8 February 2003. "
Art. 27. In section 87 of the Act, replaced by the Act of January 14, 2002, the following amendments are made:
1° The following paragraphs shall be inserted between subparagraphs 1^erand two:
"The financial resources budget is set within the overall budget referred to in paragraph 1^er, separately for each association of hospitals if it is operated by a legal entity under section 69, paragraph 2.
For the purposes of this chapter, "hospital" means a hospital or an association that is operated by a legal person as referred to in the preceding paragraph. ";
2° In the last paragraph, the words "in paragraph 1^er"are replaced by the words "in this article".
Art. 28. In the same law, an article 96bis is inserted, as follows:
"Art. 96bis. For interventions, care services and benefits that are covered on a lump-sum basis by the financial resources budget, pursuant to the provisions of this chapter, no financial intervention may be claimed from the patient."
Art. 29. Article 107, § 1^er, replaced by the Act of January 14, 2002, the current text of which will form paragraph 1^er, is supplemented by paragraph 2, as follows:
"In case of breaches of the provisions referred to in paragraph 1^eras part of an association of hospitals, the application of paragraph 1^er is done to all hospitals that are part of the association. "
Art. 30. Section 107ter of the Act, inserted by the Act of 21 December 1994, is replaced by the following provision:
"The King may set specific rules and conditions for the application of the provisions of this chapter with respect to hospital associations, as referred to in article 87, paragraphs 2 and 3."
Art. 31. Section 107quater of the Act, inserted by the Act of 22 August 2002 and partially annulled by the judgment of the Court of Arbitration No. 49/2004 of 24 March 2004, is replaced by the following provision:
"Art. 107quater. § 1^er. It cannot be claimed as a lump-sum contribution to patients in a hospital emergency care unit.
§ 2. By derogation from § 1^er, a lump-sum contribution of 9,50 euros for ordinary insured persons and 4,75 euros for the beneficiaries of the increased intervention is requested to the affected patients, up to a date to be fixed by the King, provided that their journey of care does not include one of the following situations:
1° the patient is brought to an emergency care unit pursuant to the Act of 8 July 1964 on emergency medical assistance, or by the police services;
2° the patient is admitted to the hospital via the emergency care unit for at least one night or day hospitalization as defined in the execution of Article 90, § 3, or if he remains in observation for at least 12 hours;
3° the patient is referred to the emergency care unit by a doctor;
4° the consultation begins between midnight and 6 am;
5° this is a medical treatment for which the pseudocode 0761036 is applied.
Each month, hospitals transmit to the insurance organizations referred to in section 2, i., of the Compulsory Health Care and Allowance Act, coordinated on July 14, 1994, each perception referred to in paragraph 1^er in accordance with the terms and conditions established by the Health Care Insurance Committee referred to in section 21 of the Act."
Art. 32. In the same Act, an article 107quinquies, which reads as follows:
"Art. 107quinquies. All costs related to the operations of the mobile emergency service (SMUR) are covered by the financial resources budget, with the exception of fees referred to in section 95. "
Art. 33. Article 140 of the same law as amended by the laws of 6 August 1993 and 14 January 2002 is supplemented by the following §:
"§ 6. The agreement between the manager and the medical board referred to in §§ 3 and 4 may only be amended if this does not imply that the total annual amount of the deductions made by the hospital, referred to in §§ 3 and 4, exceeds the total amount of the deductions of the 1^er January 2004 to December 31, 2004.
Derogation from paragraph 1^erthe maximum amount referred to in paragraph 1^er is adjusted according to the variation in the total annual fee amount collected in a central manner in relation to that total amount that is collected centrally in the reference period mentioned above.
This subsection does not apply if one of the following cases is satisfied:
1° where the agreement referred to in §§ 3 and 4 is approved by all members of the medical board;
2° provided that the increase in deductions is only intended for infrastructure work that means an improvement in the operation of the hospital or for doctors and nurses in the hospital;
3° provided that the increase in deductions is only intended for the financing of a public hospital recovery plan as imposed by the guardianship authority;
4° to the extent that the increase in deductions is caused by structural reforms such as fusion, association or grouping."
Section II. - Nuclear medicine services in which a PET scanner is installed
Sub-section 1^re. - Maximum number of services
Art. 34. The number of nuclear medicine services in which a PET scanner has been installed, as referred to in subsection 2, and which may be approved, is limited on the basis of the following criteria:
1° 1 service for each university faculty with a full medical curriculum;
2° 1 service for each hospital where surgical and medical services are performed, exclusively for the treatment of tumours, and which has obtained the exemption referred to in article 2, § 1^erbis of the Royal Decree of 30 January 1989 establishing the complementary standards for the accreditation of hospitals and hospital services and specifying the definition of hospital groupings and the particular standards they must meet;
3° 1 service per complete slice of 1,600,000 inhabitants, i.e. 3 services on the territory of the Flemish Region and 2 services on the territory of the Walloon Region, beyond the criteria specified in 1° and 2°.
Sub-section 2. - Service Accreditation Standards
Art. 35. For the purposes of this subsection,:
1° "the law on hospitals": the law on hospitals, coordinated on 7 August 1987;
2° scanner PET
(a) until 2 January 2004, a positrons-emission camera that produces by means of non-columbed coincidence detectors, three-dimensional radio-pharmaceutical distribution images by measuring the radiation emitted during the annihilation of radio positrons emitters, of which the detection system, mobile or non, is composed of at least one ring with which the services are performed
(b) from January 3, 2004, a positrons-emission camera that produces by means of non-sticky coincidence detectors, three-dimensional radiopharmaceutical distribution images by measuring the radiation emitted during the annihilation of positrons radioeitters, including the detection system, mobile or not, consists of at least one ring;
3° "service": the nuclear medicine service in which a PET scanner is installed;
4° "service where a magnetic resonance tomograph is installed": an approved service in which a magnetic resonance tomograph is installed, as referred to in section III of this chapter.
Art. 36. The service is considered a medical service within the meaning of section 44 of the Hospitals Act, to the extent that it meets the accreditation standards set out below.
The service must be approved as such.
Art. 37. The service must be installed in a hospital that provides evidence of sufficient oncological activity, particularly in terms of lung tumours.
The activity referred to in paragraph 1^er is demonstrated through the minimum clinical summary and any other possible information.
Art. 38. § 1^er. In the service, there must be at least one gammacamera.
§ 2. The service must be able to appeal to an approved medical imaging service in which a magnetic resonance imaging tomograph is installed, in the enclosure of the same hospital or hospital with which a cooperation agreement has been reached pursuant to §§ 4 or 6.
§ 3. In each service, only one PET scanner can be installed and operated.
By derogation from paragraph 1el, a second device may be installed in an approved service, as referred to in section 34, 1°, as part of a formalized cooperation agreement with hospitals that have carried out together, in the year preceding the application for approval or the extension of the licence, at least 100,000 admissions, of which not less than one third without overnight stay, as referred to in section 49, § 1^erParagraph 2.
In the event of application of paragraph 2, two separate services will be taken into account at the programming level.
§ 4. A service that is not operated in a university hospital must be operated as part of a formalized cooperation agreement between hospitals that have completed, in the year preceding the application for approval or the extension of the accreditation, at least 100,000 admissions, of which not less than one third without overnight stay, as referred to in section 49, § 1^erParagraph 2.
§ 5. In each hospital, one can only create and accept one service.
§ 6. A device may be installed outside a hospital, to the extent that all accreditation standards are met, within the framework of a formalized cooperation agreement with hospitals that meet the provisions of sections 37 and 38, § 4, and as long as the other elements of the service are located within one of the hospitals that operates the service.
§ 7. A hospital already operating a registered service or having already entered into a collaborative agreement, as referred to in this article, may no longer adhere to formalized collaboration as referred to in §§ 3, 4 and 6.
Art. 39. The service must have a medical staff composed of at least three full-time certified nuclear medicine specialists, a full-time physicist or engineer, and two full-time nurses exclusively occupied in this service.
As of April 7, 2003, "two full-time nursing practitioners" must be heard, two nurse art practitioners or full-time medical imaging technicians.
The service must be able to use a radiopharmacology specialist.
Art. 40. § 1^er. To maintain its approval, a service must conduct an internal and external quality assessment, in accordance with the provisions of the Royal Decree of 15 February 1999 on the qualitative assessment of medical activity in hospitals.
§ 2. The internal recording of the data referred to in section 3 of the above-mentioned Order must contain at least the following parameters:
(a) the type of tumor, anatomy;
(b) Pre-PET stage;
(c) Pre-PET prescribed therapy;
(d) the clinical questionnaire for the intended benefits;
(e) the indication, including the determination of the stage, the evaluation of therapy, and the presumption of recidivism;
(f) data from other imaging methods, with the mention of which;
(g) the result of the benefit;
h) the influence of the delivery on diagnosis, stage determination and therapy.
As long as the College of Physicians has not defined any type of registration as referred to in section 8, 2°, of the aforementioned Royal Order, each hospital must follow a registration system, meeting the conditions referred to in paragraph 1^er.
Art. 41. Article 1^er the Royal Decree of 15 February 1999 on the qualitative assessment of medical activity in hospitals is supplemented by the following provision:
"6° the nuclear medicine service in which a PET scanner is installed."
Art. 42. By derogation from section 36, the nuclear medical services in which a PET scanner is already installed on the effective date of the sections of this section may continue to be operated for a year even if they have not yet been licensed.
Section III. - Services in which a magnetic resonance tomograph is installed. - Maximum number and accreditation standards
Sub-section 1^re. - Maximum number of services
Art. 43. § 1^er. The number of approved services in which a magnetic resonance imaging tomograph is installed with integrated electronic resonance calculator as referred to in this section is limited as follows:
1° in 1999: 42 services, including 24 in the territory of the Flemish Region, 14 in the territory of the Walloon Region, and 4 in the bilingual territory of the Brussels-Capital Region for hospitals under Article 60 of the special law of 12 January 1989 on Brussels institutions;
2° from the year 2000: 53 services, including 30 in the territory of the Flemish Region, 17 in the territory of the Walloon Region, and 6 in the bilingual territory of the Brussels-Capital Region for hospitals under Article 60 of the special law of 12 January 1989 on Brussels institutions;
§ 2. By university faculty of medicine offering a full study program, a service referred to in § 1^er is not counted in the number referred to in § 1^er.
Sub-section 2. - Accreditation standards for services
Art. 44. For the purposes of this subsection,:
1° "the organic law of 8 July 1976": the organic law of 8 July 1976 on public social action centres;
2° "the royal decree of 28 November 1986": the royal decree of 28 November 1986 fixing the standards to which a medical imaging service where a transverse axial tomograph is installed must meet to be approved as a medico-technical service within the meaning of Article 6bis, § 2, 6°bis, of the Hospital Law;
3° "medical imaging service": a service approved in accordance with the Royal Decree of November 28, 1986;
4° magnetic resonance tomograph:
(a) until 8 February 2003, the magnetic resonance imaging tomograph with integrated electronic calculator;
(b) from 9 February 2003, the magnetic resonance imaging tomograph with electronic calculator, including the specific-use device that can only work for a limited indication field.
Art. 45. The service in which a magnetic resonance tomograph is installed is considered to be a medical-technical service referred to in section 44 of the Hospitals Act, coordinated on August 7, 1987, provided that it meets the conditions of this subsection.
Art. 46. The service referred to in section 45 shall meet the following conditions:
1° service is approved as a medical imaging service;
2° the magnetic resonance tomograph that is installed in the service meets the criteria referred to in section 47;
3° the service shall occupy at least four full-time licensed radiologists;
4° among the radiologists occupied in the service, who use the magnetic resonance tomograph, at least 2 shall:
(a) having completed a full-time complementary training of at least six months in a university internship service, in Belgium or abroad, familiar with the use of the magnetic resonance slider;
(b) receive specific training in the application of this technique during their training. The proof of the training referred to in (a) is provided by a certificate issued by the head doctor of the university internship service. The proof of the training referred to in (b) is provided by a copy of the accreditation as a specialist physician in accordance with the provisions of the Ministerial Order of 8 December 1980 setting the special criteria for the accreditation of specialist doctors, internship teachers and internship services for the specialty of radiodiagnostic.
These documents are attached to the service's accreditation file.
Art. 47. The magnetic resonance tomograph can only be installed if it meets the following criteria:
1° the installation shall be equipped with the specialized antennas necessary for the various examinations;
2° a minimum of safety facilities must be present, allowing visual and acoustic contact between the patient and the examiner, electrocardiogram monitoring, metal detection device, a non-ferromagnetic patient transport system, a suitable resuscitation system, a suitable fire-resistant system;
3° location and installation shall meet minimum requirements for magnetic interaction and protection of radio frequency waves.
The use of the device is, in accordance with the rules to be fixed by the King, subject to a "peer review" in order to assess the quality of the work of the users.
Art. 48. § 1^er. A magnetic resonance imaging tomograph may only be installed in a medical imaging service located in a hospital and having an approval under this subsection.
Derogation from paragraph 1^er and Article 46, paragraph 1^er, 1° and 3°, a magnetic resonance imaging can be installed in a service established outside a hospital, provided that the above-mentioned service has been approved before 1^er January 1999 on the basis of Article 8 of the Royal Decree of 27 October 1989 fixing the standards to which a service in which a magnetic resonance tomograph is installed with integrated electronic calculator must meet to be approved as a medico-technical service within the meaning of Article 44 of the Hospitals Act, coordinated on 7 August 1987, as this provision was in force until the date of entry into force of this section and to the lesser extent The legal person concerned must take the form of a non-profit association or an association referred to in section 118 of the Act of 8 July 1976. This service must not be approved as a medical imaging service provided that it cannot be located more than 1 km from the hospital concerned or one of the hospitals concerned that must have a medical imaging service. By derogation from article 46, paragraph 1^er, 3°, it is sufficient that all the hospitals concerned have the equivalent of four full-time radiologists.
§ 2. In a medical imaging hospital, approved under this Act, a single magnetic resonance imaging tomograph may be installed, except in the case of application of section 49, §§ 3, and 6, and section 50.
Art. 49. § 1^er. Without the number of services referred to in Article 43, § 1^er, cannot be exceeded, particularly in the light of the application of Article 48, § 1^er, and of § 6, of this article, a medical imaging service with a magnetic resonance tomograph can be operated with a single device in a hospital that has made an annual number of 25,000 admissions, of which at least two thirds have at least one night.
Among admissions that do not include overnight stays, admissions to day-to-day hospitalizations, as referred to in Article 4, §§ 3, 6 and 7 of the agreement between care facilities and insurance organizations, concluded on January 24, 1996 pursuant to Article 46bis of the Compulsory Health Care and Allowance Insurance Act, coordinated on July 14, 1994, and as amended by the second amendment clause entered into on January 28,^er. Nor are admissions to a functional rehabilitation institution referred to in article 23, § 3 of the same coordinated law of 14 July 1994 taken into consideration, including or not involving a night.
The number of admissions referred to in paragraph 1^er, to be carried out in 1998 or on average during the years 1996, 1997 and 1998. Ministers who have public health and social affairs in their duties may specify the rules that require hospitals to demonstrate to the appropriate accreditation authority the number of admissions, as referred to in paragraph 1^er.
For the purposes of this paragraph, hospitals have the largest number of annual admissions that are approved as a priority.
§ 2. As long as the number of services referred to in Article 43 is not reached because of §§ 1^er and 6, a service may be operated with a single device in a hospital that has completed an annual number of 20,000 admissions, of which two thirds have at least one nigger.
§ 1^er, paragraphs 2, 3 and 4 are also applicable.
The approval authority may, by derogation from § 1^er, paragraph 4, approving services eligible for this purpose under this section, taking into account the concern for a better geographical distribution and/or the existence of a need - in particular with regard to the nature and volume of the pathologies they treat - relating to this activity, as referred to in section 45bis of the Hospitals Act, coordinated on August 7, 1987.
§ 3. As long as the number of services referred to in Article 43 is not reached because of §§ 1^er, 2, and 6, a second device may be installed in a registered service of a hospital that is not referred to in section 50 and has completed at least 35,000 admissions per year, as referred to in § 1^er.
§ 1^er, paragraphs 2, 3 and 4 is also applicable. The approval authority may, by derogation from § 1^er, paragraph 4, approving eligible services pursuant to this subsection, taking into account the concern for a better geographical distribution and/or the existence of a need - in particular with regard to the nature and volume of the pathologies they treat - relating to this activity, as referred to in section 45bis of the Hospitals Act, coordinated on August 7, 1987.
§ 4. As long as the number of services referred to in Article 43 is reduced by the number of services for which § 3 is applied, is not reached because of §§ 1^er, 2, and 6, a service can be operated with a single device in a hospital that has made an annual number of 15,000 admissions, of which at least two thirds have at least one night.
§ 1^er, paragraphs 2, 3 and 4, is also applicable.
The approval authority may, by derogation from § 1^er, paragraph 4, approving eligible services pursuant to this subsection, taking into account the geographic distribution and/or the existence of a need - in particular with regard to the nature and volume of pathologies they deal with relating to this activity in an area of attraction, as referred to in section 45bis of the Hospitals Act coordinated on August 7, 1987.
§ 5. As long as the number of services referred to in Article 43, diminished the number of services for which § 3 is applied, is not reached because of §§ 1^er, 2, 4 and 6, an approved service with a device can be operated until 8 February 2003 as part of a formalized collaboration between hospitals that, jointly, meet the conditions set out in § 4.
Paragraphs 2, 3 and 4 of § 1^er are also of application.
The approval authority may, by derogation from § 1^er, paragraph 4, approving eligible services pursuant to this subsection, taking into account the geographic distribution and/or the existence of a need - in particular with regard to the nature and volume of pathologies they deal with relating to this activity in an area of attraction, as referred to in section 45bis of the Hospitals Act coordinated on August 7, 1987.
§ 6. The conditions for the number of hospitalizations referred to in §§ 1^er, 2, 3 and 4, may, from 9 February 2003 be satisfied by several hospitals as long as, for a service referred to in section 45, these hospitals are part of an association or formalized cooperation agreement and provided that the sites performing the main activity of each of these hospitals are within a radius of 5 km each other.
§ 7. Without prejudice to the application of Article 48, § 1^er, the services approved on the date of the coming into force of this Act shall remain approved until 31 December 2000 or until the date on which their approval is terminated if it is located after the above-mentioned date, subject to limitation to a device for general hospitals and two devices for university hospitals with a maximum of one additional device per faculty of medicine with a full curriculum.
This approval is, if any, extended by the competent authority, provided that the services concerned are operated either by hospitals that carry out at least 15,000 admissions per year, or under a formalized cooperation agreement between the hospitals that together perform at least 15,000 admissions per year, and provided that these services meet the other conditions of Article 46, provided that, in the case where the service is operated in the formalized framework
§ 8. Within two years after the entry into force of this section, only one additional device may be installed by service.
Art. 50. As long as a university hospital has an approved service and meets the requirements of Article 49 §§ 1^er or 2, an additional device may be installed, with a maximum of one additional device per faculty of medicine with a full curriculum, taking into account the specific training mission as well as the development of new applications and procedures.
When a university hospital referred to in paragraph 1^er realizes at least 55,000 admissions, as referred to in Article 49 § 1^era third device can be installed in the approved service.
Art. 51. Until February 8, 2003, specific-use devices, which operate only for a limited field of indication, can only be installed in an approved service, as an additional device pursuant to Article 49, §§ 3 or 6, and Article 50, and provided that the first device has an intensity of at least 1 Tesla.
Art. 52. § 1^er. To remain approved, a medical imaging service with a magnetic resonance imaging tomograph must carry out internal verification and conduct the external verification of the quality of medical activity, in accordance with the availability of the Royal Order dated 15 February 1999 concerning the qualitative assessment of medical activity in hospitals.
§ 2. The internal registration referred to in section 3 of the above-mentioned Royal Decree must at least meet the following conditions:
1° it must include sufficient parameters to allow the evaluation of the quality of the medical activity;
2° it must be performed for each patient, regardless of the evolution of the situation;
3° it must state any contact between the patient and the service.
The parameters to be recorded referred to in paragraph 1^erat least the following:
1° the installation report;
2° the periodic report of the inspection service and the approved maintenance agency;
3° evidence of permanent training of radiologists;
4° the clinical justification of the examination;
5° the duration of the examination;
6° the means of contrast used;
7° the increasing factors, such as sedation, anesthesia, alitement, monitoring;
8° the postprocessing used;
9° the result of the examination;
10° the specialty of the prescribing physician (the last 3 digits of the N° INAMI);
11° the ambulatory or hospitalized character of the patient.
As long as the College of Physicians has not developed a registration model within the meaning of section 8, 2°, of the aforementioned Royal Order, each hospital must apply a registration system that meets the requirements of paragraph 1^er.
Art. 53. § 1^er. Where the service referred to in section 45 meets the standards of this subsection, the service shall be granted approval.
§ 2. The approval refers to the number of devices for which it is granted, the duration of the approval and the possible application of section 51.
§ 3. In the absence of a medical imaging service, pursuant to this subsection, no magnetic resonance imaging tomograph referred to in this Act may be installed.
§ 4. When it is found that it is no longer satisfied with the standards, the approval is withdrawn.
Art. 54. The Minister who has the Public Health in his or her duties is informed by the Minister who has the accreditation of medical imaging services in his or her duties:
(a) the decision granting approval with reference to the manner in which it is satisfied with each of the standards of this subsection;
(b) the decision to withdraw an approval, with the reason for it;
(c) of the minutes stating that a magnetic resonance imaging tomograph is not installed in accordance with the standards of this subsection.
Art. 55. In 1999, only the services for which an application is filed with the competent authority, within four weeks of the entry into force of this section, may be approved.
In 2000, only the services for which an application is filed with the competent authority before 31 December 1999.
Art. 56. The Royal Decree of 27 October 1989 setting out the standards for which a service in which a magnetic resonance tomograph is installed with an integrated electronic resonance calculator must meet to be approved as a medical-technical service within the meaning of section 44 of the Hospitals Act, coordinated on 7 August 1987, amended by Royal Decrees of 29 June 1989, 21 June 1994 and 26 May 1995, is repealed.
Section IV. - Entry into force
Art. 57. § 1^er. Sections 27, 30 and 31 come into force on 1^er July 2005.
§ 2. Article 24, 2° shall cease to be in force on 1^er May 2007.
Article 31, § 2, shall cease to be in force at a date to be fixed by the King.
§ 3. Section 33 comes into force on 1^er July 2005 and will cease to be in force on June 30, 2006.
§ 4. Articles 34 to 42 produce their effects on 29 August 2000, with the exception of Article 35, 2°, (b), which produces its effects on 3 January 2004 and Article 39, paragraph 2, which produces its effects on 7 April 2003.
Article 35, 2°, (a) will cease to produce its effects on 3 January 2004.
Articles 34 to 42, with the exception of section 35, 2°, (a), shall cease to produce their effects on a date to be fixed by the King.
§ 5. Article 43 produces its effects on 13 August 1999 and will cease to be in force on a date to be determined by the King.
§ 6. Articles 44 to 56 included produce their effects on 13 August 1999, with the exception of articles 44, 4°, (b) and 49, § 6, which produce their effects on 9 February 2003.
Articles 44 to 55 shall cease to be in force on a date to be fixed by the King, except for articles 44, 4, (a), 49, § 5, and 51, which cease to produce their effects on 9 February 2003.
PART IV. - Control of the 2005 budget objective of health care insurance
Art. 58. § 1^er. For the purpose of realizing the 2005 overall budget objective in health care insurance, the King may, by order deliberately in the Council of Ministers, take the measures referred to in this article.
These measures must produce their effects in the course of 2005.
§ 2. By derogation from the procedures set out in the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, the King may, by order deliberately in the Council of Ministers, take measures to:
1° to combat any form of improper use and abuse and to ensure effective control of expenses, in and outside care facilities;
2° adapt the intervention of the insurance and the terms and conditions of award and the amounts that are used as a basis for the calculation of the intervention of the health insurance coverage referred to in section 34 of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994.
To this end, it may take all necessary measures and make any useful amendments to the above-mentioned law in order to achieve the necessary savings in order to:
1° to adapt the rules relating to the establishment of the health care budget and the correction mechanisms;
2° to adapt the rules relating to the overall budget of benefits granted to beneficiaries in a hospital;
3° to amend the nomenclature of health benefits by derogation from the conditions set out in article 35, § 2, of the aforementioned law of 14 July 1994;
4° to adapt the maximum billing provisions fixed on the basis of the income of the beneficiaries' household and executed either by the insurers or by the Administration of Corporate Tax and Revenue;
5° to strengthen the missions and role of the Budget Control Commission and the function of budgetary and financial advisor;
6° to specify and adapt the missions and the composition of the advisory bodies of functional rehabilitation and profile commissions;
7° to amend personal interventions for visits and consultations of general practitioners and specialist physicians by derogation from the procedure set out in article 36 of the aforementioned law of 14 July 1994;
8° to simplify the procedures for amending the lists referred to in section 35bis and section 35ter of the aforementioned Act of 14 July 1994;
9° to amend the conditions and rules under which a benefit is granted to certain physicians if they meet the quality and quantity requirements of medical practice, by derogation from the procedure set out in section 36bis of the aforementioned Act of 14 July 1994;
10° to adapt the rules relating to data and documents to be transmitted to the Institute by the dispensators, by the pricing boards and by the insurers;
11° to adapt the provisions relating to the reduction of the intervention of the insurance by pharmacists, referred to in section 165, last paragraph, and to the dependant contributions of pharmaceutical firms, referred to in section 191 of the aforementioned Act of 14 July 1994;
12° adapt the procedure for setting the recommendations and indicators referred to in Article 73, § 2, of the aforementioned Law of 14 July 1994;
13° amend the limitation periods referred to in section 174 of the above-mentioned Act.
§ 3. By derogation from the above-mentioned Act of 14 July 1994 and the Act of 25 April 1963 on the Management of Public Interest Organizations of Social Security and Social Security, for the period of 1^er April 2005 to December 31, 2005, notices and proposals that must be collected or formulated must be issued within the time limit set by the Minister, which cannot be less than eight days. If the proposal is not formulated or the notice is not issued within the time limit, they are considered to have been given.
§ 4. Orders made under this section may repeal, supplement, amend or replace existing statutory provisions relating to compulsory health care insurance or care facilities.
§ 5. Orders made under this Article may supplement, amend or replace the conventions referred to in Article 23, § 3, of the aforementioned Law of 14 July 1994.
§ 6. The Orders referred to in § 2 shall be communicated to the Presidents of the House of Representatives and the Senate for publication to the Belgian Monitor.
§ 7. The authorization granted to the King by this article comes into force on 1^er April 2005 and ends on 31 December 2005.
§ 8. Orders made under this Article shall cease to produce their effects on December 31, 2006, when they were not confirmed by the legislator before that date.
Art. 59. In section 19 of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, amended by the Royal Decree of 25 April 1997 and by the Act of 24 December 1999, the following paragraphs are inserted between paragraphs 1^er and 2:
"It is established, with the Scientific Council, a Committee for the Permanent Review of the nomenclature of Health Benefits, to provide advice on:
1° the simplification of the nomenclature of health benefits by adaptation or consolidation of health benefits, particularly in the context of well-defined syndromes and care programmes;
2° the revision of the relationship between the relative value of benefits, taking into account their cost, available scientific evidence and other factors determining objective value;
3° the introduction of new rules relating to the billing conditions of health benefits with a view to achieving a more effective allocation of means;
4° the introduction of new benefits based on an in-depth evaluation of the technology and its impact on health care insurance;
The Committee ' s views are limited to the only benefits that may be provided by doctors.
The Committee is composed of:
1° of a president elected from the 5° members;
2° of three members, doctors, presented by professional organizations representative of the medical body;
3° of three members, doctors, presented by insurers;
4° of three members, doctors nominated among the candidates nominated by the medical schools of Belgian universities;
5° of three members, doctors, at least one of whom has special expertise in health economy, appointed by the Minister because of their particular knowledge;
6° of two members, doctors, appointed respectively by the senior official of the Health Care Service and the senior official of the Medical Control Service.
Members shall designate persons who may replace them in the course of their term, taking into account the matter examined.
The members referred to in paragraph 4, 6° shall have an advisory vote.
The Committee may be assisted by other experts.
The Minister may, on a proposal or after notice by the Committee, establish working groups to examine specific aspects related to the Committee's mission. "
Art. 60. In section 35bis of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, inserted by the Act of August 10, 2001 and amended by the Acts of December 24, 2002, December 22, 2003 and July 9, 2004, the following amendments are made:
1° to § 1^er, fourth sentence, the words "in § 4, paragraph 4" are inserted between the words "in § 3, last paragraph", and "and in § 8, last paragraph".
2° § 4, paragraph 3, is replaced by the following paragraphs:
"The Drug Refund Commission may propose a group review of the reimbursement for pharmaceutical specialties used for an identical or similar indication, regardless of whether or not the specialties concerned are considered for an individual review. A group review may result in a group or individual modification of the refund base, refund terms and/or rebate category, or a deletion of the list after assessment on the basis of one or more criteria referred to in § 2. The Drug Refund Commission decides on its own initiative or at the request of the Minister, when a group review occurs.
If, as part of a group review, the proposal of the Drug Refund Commission is not made within the time limit provided by the Minister, the proposal is expected to have been given.
If a group review is carried out only, or in part, on the basis of § 2, 2°, the Drug Reimbursement Commission may invite all the applicants concerned to formulate proposals for adaptation of the Specialty Rebate Base, in accordance with the procedure established by the King. This group review is intended only for specialties referred to in article 34, paragraph 1, 5°, (c), (1) and (2). The King may determine, by order deliberately in the Council of Ministers, the procedure for applying to specialties whose main active substances are different salts, esters, ethers, isomers, mixtures of isosters, complex or derived from the main active substances of a speciality referred to in article 34, paragraph 1, 5°, c), (1) or (2) unless these specialties are of a more substantial value and
The Drug Refund Commission may propose as part of the group review referred to in paragraph 5:
1° to classify the relevant pharmaceutical specialties into different reimbursement categories proportionally to the reimbursement base proposed by the applicants;
2° to classify pharmaceutical specialties in the same rebate category on the understanding that a reduced repayment base is applied to all the specialties of the group concerned. ";
3° § 11 is replaced as follows:
"The King may set the rules under which the prior authorization of the consulting physician referred to in § 10, paragraph 1, is no longer required, both in the context of a group review referred to in § 4 and outside."
Art. 61. In section 35ter of the Act, inserted by the Act of 2 January 2001, amended by the Act of 10 August 2001 and the Royal Decree of 27 November 2002, the following amendments are made:
1st paragraph 1^er is replaced by the following paragraph: "For specialties, referred to in article 34, paragraph 1^er, 5°, c), 1), a new refund base is fixed as long as other pharmaceutical specialties with an identical active principle are refunded, the basis of which, at the time of admission, is or was less than 16 p.c. given the number of pharmaceutical units per packaging, and whatever the route of administration and dosage. This provision does not apply to forms of a specialty for which a specific therapeutic value significantly higher than other forms of speciality or specialties with the same active principle is demonstrated according to the conditions fixed by the King. This provision is, for injectable forms, only of application provided that another injectable form is repayable, the basis of reimbursement, at the time of admission, is or was at least 16 p.c. given the number of pharmaceutical units per packaging. ";
2° Paragraph 2 is supplemented as follows:
"From 1^er May 2005, the percentage decrease is 30 p.c.
1^er July 2005 the reimbursement base calculated on the basis of the ex-factory price of all specialties to which as of June 30, 2005 the basic reduction of reimbursement referred to in section 35ter was applied is reduced by 5.4%.";
3° in the seventh paragraph, the last sentence is deleted. "
Art. 62. In the same Act, an article 35quater is inserted as follows:
"Art. 35quater. In accordance with the terms and conditions established by the King, the Drug Reimbursement Commission defines, on a case-by-case basis, on its initiative or at the request of the Minister, groups of specialties whose indications and mechanisms of action are identical or similar to those of specialties referred to in section 35ter. A new refund base is set for specialties designated on the basis of the ex-factory price reduced according to the rules set out in section 35ter.
This provision is applicable to the specialties referred to in article 34, paragraph 1, 5°, (c), (1) and (2) as well as to specialties whose main active substances are different salts, esters, ethers, isomers, mixtures of issomers, complex or derived from the main active substances of a specialty referred to in article 34, paragraph 1^er, 5°, c), 1) or 2) unless these specialties have a more substantial value in terms of safety and/or efficiency.
The provisions of section 35ter and 35quater may not be applied to the same specialty. "
Art. 63. An article 35quinquies as follows is inserted in the same law:
"Art. 35quinquies. Without prejudice to the provisions of section 35ter, the King may, by a royal decree deliberated in the Council of Ministers, set out the conditions and rules that the basis for the reimbursement of specialties taken on the list referred to in article 35bis may differ from the public price applied for these specialties. The difference between the public price and the refund base shall be borne by the applicants referred to in section 35bis, unless this difference is due to the application of the basic reduction in reimbursement referred to in section 35ter.
The amounts concerned shall be transmitted to the Institute under the conditions and time limit set by the King."
Art. 64. In the same law, an article 35sexies is inserted as follows:
"Art. 35sexies. Without prejudice to the provisions of Article 29bis, the Drug Reimbursement Commission is mandated to review each year, and the first time for the 1st^er May 2006, for classes designated by the Minister if, for an identical or analogous indication, there is one or more refunded specialties that do not have, in the current state of the knowledge, a significant therapeutic surplus-value compared to one or more repayable specialties whose reimbursement base is lower.
The Commission shall prepare an annual report of the analyses it conducted in accordance with paragraph 1^er. She communicates it to the Legislative Chambers and the Minister.
On the basis of this report, the Minister or the Drug Refund Commission may initiate a procedure for amending the terms and conditions for reimbursement of one or more specialties for which the King may establish additional terms and conditions. "
Art. 65. In section 72bis of the Act, inserted by the Act of 20 December 1995 and replaced by the Act of 10 August 2001, the following amendments are made:
1° In § 2, after the third sentence, the following sentence is inserted:
"For reasons related to public health or social protection, the Minister may reject a request for deletion, or set a later date for the effective date of deletion. ";
2° it is inserted a § 2bis, written as follows:
"§ 2bis. When no claims have been made for certain pharmaceutical specialties, these specialties may be admitted to reimbursement when the Minister or the Drug Refund Commission finds that beneficiaries are deprived of an insurance intervention for valid therapeutic means.
The King sets out the procedure whereby the specialties concerned may be listed in section 35bis. "
Art. 66. In section 165, paragraph 9, of the Act, as amended by the Acts of 22 February 1998, 15 January 1999, 25 January 1999, 10 August 2001, 30 December 2001, 22 August 2002, 8 April 2003 and 27 December 2004, the following amendments are made:
1° the words "communication, within the framework of their legal missions, by the information insurers customized to their insured persons on the financial consequences of choosing a specialty as well as to the care providers and prescribers concerned in order to pay attention to the financial consequences of this consumption for the patient and health care insurance," are inserted between "Article 34, 4°," and "as well".
2° The following sentence is added: "The King may set the terms of application for the communication of information to patients, prescribers and service providers. "
Art. 67. Article 191, paragraph 1^erthe same Act, as amended by the Acts of 10 August 2001, 2 August 2002, 22 August 2002, 24 December 2002, 22 December 2003, 9 July 2004 and 27 December 2004, are amended as follows:
1° 15°quater, § 1^er, paragraph 4, is supplemented as follows:
"For the contribution due from 2006, the total amount of the contribution is 72 p.c. of this exceedance. ";
2° in the 150 quater, § 1^erParagraph 1^er, last sentence, words "before 1^er July 2005 is replaced by the words "before November 15, 2005";
3° in 15°sexies, paragraph 1^er, the reference "4.67 %" is replaced by "5,52%";
4° 15°Sexies is supplemented by the following paragraphs:
"According to the more detailed rules set at 15°, a special contribution of 5.52 % is introduced for the year 2006 on the turnover made on the Belgian market during the year 2004 by the drugs listed in the list of refundable pharmaceutical specialties.
This contribution is dependent on applicants who made this turnover in 2004. This contribution must be paid before 1^er July 2006 on account number 001-1950023-11 of the National Institute of Disability Health Insurance, mentioning "special benefit in fiscal year 2006. "
Art. 68. From 1^er January 2005 and until the date to be fixed by the King by order deliberately in the Council of Ministers, no revisions or derogations are permitted under Article 3 of the Ministerial Order of December 12, 2000 setting the price of large packagings of repayable drugs as of December 15, 2000 and Article 3 of the Ministerial Order of February 21, 2000 decreasing the price of certain repayable drugs.
Art. 69. 1^er September 2005, with the exception of specialties in reimbursement groups I.10.1, I.10.2, V.6.3, V.6.4, V.8.1, VI1.9, VII.10 and XXII, the prices and bases of reimbursement of specialties of chapters I^erII and IV of Appendix I^re the list attached to the Royal Decree of December 21, 2001, setting out the procedures, deadlines and conditions for the intervention of compulsory health care insurance and compensation in the cost of pharmaceutical specialties, of which, at 1^er July 2005, each active principle appears in a speciality which was repayable for the first time more than twelve years and less than fifteen years ago, is reduced by 14%.
1^er September 2005, with the exception of specialties in reimbursement groups I.10.1, I.10.2, V.6.3, V.6.4, V.8.1, VII.9, VII.10 and XXII, the prices and bases for reimbursement of specialties of chapters I^erII and IV of Appendix I^re the list attached to the Royal Decree of December 21, 2001, setting out the procedures, deadlines and conditions for the intervention of compulsory health care insurance and compensation in the cost of pharmaceutical specialties, of which, at 1^er July 2005, each active principle appears in a speciality which was repayable for the first time more than fifteen years and less than seventeen years ago, is reduced by 2.3 per cent.
Then each 1^er January and 1^er July, with the exception of specialties in reimbursement groups I.10.1, I.10.2, V.6.3, V6.4, V.8.1, VII.9, VII.10 and XXII, the prices and bases of reimbursement of specialties of chapters I^erII and IV of Appendix I^re the list attached to the Royal Decree of December 21, 2001, setting out the procedures, deadlines and conditions for the intervention of compulsory health care insurance and compensation in the cost of pharmaceutical specialties, of which, in the course of the preceding semester, each active principle appears in a speciality that was repayable for the first time more than twelve years ago are diminished by 14% and in a specialty that was repayable for the first time 3 years ago.
The King may amend the percentage referred to in paragraph 1^er and 2.
The King may exclude from the scope of this article the pharmaceutical specialties for which the applicant has demonstrated that the active ingredient(s) as reproduced in the Anatomical Therapeutical Chemical Classification established under the responsibility of the World Health Organisations Collaborating Center for Drug Statistics Methodology, are protected by a patent or a complementary certificate of protection of the patent, unless the main paragraph(s) are different salts, esters, "
Art. 70. In Article 9 of the Law of 25 March 1964 on Drugs, as amended by the Law of 21 June 1983, it is inserted a § 3, and a § 4, as follows:
"§3. In the interest of public health, the King may regulate or subject to selective prohibition measures any information relating to human health or human diseases if that information makes a direct or indirect reference to a drug or group of medications. "
"§ 4. It is prohibited for any natural or legal person to make public advertising for implantable medical devices. It is also prohibited to advertise for acts of laying or implanting these medical devices.
For the purposes of this paragraph, "Implantable Medical Device" means:
any device intended for:
- to be fully implanted in the human body, or
- to replace an epithelial surface or the surface of the eye, thanks to surgery and to remain in place after surgery.
It is also considered an implantable device intended to be partially introduced into the human body by a surgical procedure and intended to remain in place after the intervention for a period of at least thirty days.
The King may extend the definition referred to in paragraph 2.
Art. 71. In Article 10 of the Act, replaced by the Act of 16 December 2004, a § 7 is inserted as follows:
"§ 7. The provisions of this article shall apply to medical devices and accessories. For the purposes of this paragraph, the following is understood:
1° "medical device": any instrument, device, equipment, material or other article, used alone or in association, including the software necessary for the proper operation of the latter, intended by the manufacturer to be used in man for the purposes of:
- diagnosis, prevention, control, treatment or mitigation of a disease,
- diagnosis, control, treatment, mitigation or compensation of an injury or disability,
- study or replacement or modification of anatomy or physiological process,
- the control of the design, and whose main action desired in or on the human body is not obtained by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means;
2° "accessory" : any article which, although not a device, is specifically intended by its manufacturer to be used with a device to allow the use of the device in accordance with the use referred to by the manufacturer of this device.
The King may extend the definitions referred to in paragraph 2."
Art. 72. The King sets the effective date of Article 66.
Art. 73. An article 11bis, written as follows, is included in the Act of 13 February 2005 on administrative simplification:
"Art. 11bis. Physicians who, as of the date of entry into force of this Act, were exempted under sections 3 and 4 of the Act of 12 April 1958 relating to the medicinal-pharmaceutical cumulation, are authorized to hold a deposit and issue drugs up to two years after the date of entry into force of this Act.
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Brussels, 27 April 2005.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
R. DEMOTTE
Seal of the state seal:
The Minister of Justice,
Ms. L. ONKELINX
____
Notes
Previous documents Doc 5116271 (2004/2005):
001: Bill.
002 to 004: Amendments.
005: Report.
006: Text adopted by the Commission.
007: Amendments.
008: Supplementary report.
009: Text adopted by the commission.
See also
Full report 13 April 2005.