Methodological guidance on indication and prediction of dietetic foods included in the list of categorised dietetic foods in the therapeutic group enterical nutrition with effect from 1.7.2013

With effect from 1.7.2013 dietetic foods of outpatient enteral nutrition in the list of categorised dietetic foods (hereinafter referred to as "the list of dietetic foods') in accordance with § 57 (2) of Act No. 363/2011 Coll. on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws as amended (hereinafter referred to as "the Act') are included in new subgroups of dietetic foods with their characteristics, which are published on the website of the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') at: http://www.health.gov.sk/Clanok?zkdp201307.

I. Indication and prescription

II. General:

the conditions for indication and prescription are set out in the extent specified in Part A, B; and C of the published list. In Part A, the following information and information are essential for the indicating and rescribing physician:

• Code and name of the dietary food,
• the wording of the indication limit:
  • for adults and children from four years of age:
    • Castle treatment is indicated in adult patients with malnutrition confirmed by the initial indication protocol of outpatient enteral nutrition for adult patients (Protocol No 2, Annex 1 to Part 1). B indication restrictions) or in children of 4 years of age with malnutrition confirmed according to the initial indication protocol of ambulatory enteral nutrition for children (Protocol No.1 , Annex 1 to Part B indication restrictions).
      
      On the basis of public health insurance, dietary foods prescribed and used for indications corresponding to the purpose of determining the dietary food on its packaging shall be fully or partially reimbursed.
      
      The basic condition for the paid treatment with polymeric diets is the completed protocol No.2 or No.1 stored in the prescriber's medical documentation. Medically justified efficacy of polymer diet treatment is continuously monitored and recorded in medical documentation.

• for children:
  • Treated treatment with polymeric diets is indicated in children with malnutrition documented in the protocol for the indication of ambulatory enteral nutrition for children (Protocol No.1 , Annex No.1 to Part 1) B indication restrictions).
    
    

On the basis of public health insurance, dietary foods prescribed and used for indications corresponding to the purpose of determining the dietary food on its packaging shall be fully or partially reimbursed.

The basic condition for receiving polymeric diets is filled in indicating protocol stored in the prescriber's medical documentation. Medically justified efficacy of polymer diet treatment is continuously monitored and recorded in medical documentation.

Part of the indication restrictions are Protocol Nos 1 and 2, which are published on the Ministry's website as an annex to Part B list here: http://www.health.gov.sk/Sources/category/zkdp/201307/Apposition c 1 k casti B ind restriction k 01 7 2013.rtf;

separately Protocol No 1 HERE or at: http://www.health.gov.sk/Sources/category/zkdp/201307/Protocol c 1.rtf;

separately Protocol No 2 HEREor at: http://www.health.gov.sk/Sources/category/zkdp/201307/Protocol c 2.rtf

Protocol No 1 is intended for children from 1 month to 18 years of age and 364 days.
Protocol No 2 is intended for adults from 18 years of age 364 days.
Under the terms of SeniorWe understand a patient over 65 years of age.
Lying patient is any patient who, at the time of indication of treatment with outpatient enteral nutrition, is immobile (not able to walk alone, cannot stand on weight...) and is dependent on the assistance of another person.
Medically justified treatment effectiveness is based on medical criteria related to the indication of treatment in association with the underlying disease or the condition which caused it and does not take into account the social criteria.

The patient must first tolerate the treatment well in order to demonstrate the effectiveness of the treatment. Consequently, it must benefit physically and mentally, as demonstrated by, for example, stabilisation or improvement of its physical condition, stabilisation or weight gain, or laboratory parameters that take into account the balance between the intake of nutrition and nutritional needs of the organism.
Treatment benefit must be assessed in the context of the underlying disease or condition and on the basis of medical criteria. Stabilization of physical condition is assessed on an individual basis compared to the condition at the time of indication of treatment. The stabilization of physical condition means maintaining or improving the quality of life of the patient due to the physical and psychological abilities of his body.

• Text of the limitation the prescription of a dietetic food is linked to the professional competence of the physician, which is listed in Part A and Part E of the list.
  Pursuant to Article 119 (10) and (11) of Law No 362/2011o on medicinal products and medical devices Z. z., as amended, a doctor with specialization in the relevant specialization field, assigned by the Health Care Supervisory Authority a code number and who has concluded a health care contract with the health insurance company in which the patient is insured, is obliged to prescribe a dietetic food.
  
  A doctor specializing in specialization general medicine and a doctor specialised in specialization paediatrics can prescribe a dietetic food which is linked to the expertise of the physician only on the basis of written advice from a specialist. In the recommendation to the general physician, the specialist shall indicate how long the general physician's dietetic food should be prescribed to the patient; this period shall not exceed six months. When prescribing, the general doctor shall write on the back of the prescription, in the case of a dietetic food, a note "FOR A PROFESSIONAL RECOGNITION" indicating the name and surname and code of the professional doctor, the name, registered office and health care provider and the date of the medical report in which he recommended the prescription of the dietetic food. The General Doctor shall authorise the note by means of his stamp, date and signature.
  
  

It follows from the above that if, for example, one specialist indicates the initial treatment with enteral nutrition, another specialist, but only a general physician or a pediatrician, cannot continue the prescription under the conditions laid down by law.

We recommend that organ specific diets for nutritional support for 6 months has been prescribed by a specialist and only after the approval of continued medical treatment by a general practitioner. The initial treatment indication protocol remains in the patient's medical documentation with the physician who initiated the treatment (prescribed). In the patient' s medical documentation, the general physician will note that treatment is continued as recommended by the specialist. Communication between the specialist and the general physician takes place as standard through exchange tickets.

• quantitative limit, indicates the amount of dietary food covered by public health insurance, expressed as:
  • in part C by kcal quantity, paid from public health insurance for individual forms of enteral nutrition and treatment stage:
    • nutritional support:
      • initial treatment 14 days - covered up to 675 kcal/day - 9450 kcal summary;
      • continued treatment for 31 days – covered by 675 kcal/day - 20 925 kcal summary;
    • Full nutrition – for 31 days covered up to 2000 kcal/day - 62 000 kcal summary;
  • in Part AaH list in whole pieces according to enteral nutrition and treatment stage:
    • nutritional support:
      • initial therapy L6 (kcal is calculated and mathematically rounded to whole packages of dietetic foods),
      • Continued treatment limit L7 (kcal are calculated and mathematically rounded to whole packages of dietetic foods);
    • full enteral nutrition – limit L8 (kcal is calculated and mathematically rounded to whole packages of dietetic foods) and

• the composition and purpose of the dietetic food, which is indicated on the packaging of a dietetic food published on the Ministry's website here: http://www.health.gov.sk/Sources/category/zkdp/201307/V06E enteralna vyziva text na obale DP.zip

III. New patient indicated since 1.7.2013 for outpatient enteral nutrition:

The ability of the gastrointestinal tract to absorb a nutritional preparation is a clear condition to indicate and reskirt outpatient enteral nutrition.

• A new patient will come to the doctor's office.
• The physician will clinically evaluate his nutritional status.
• He's going to write indicator protocol 1 or 2, which he chooses according to the age of the patient. (Protocol No 1 is intended for children from 1 month to 18 years and 364 days. Protocol 2 is intended for adults from 18 years of age 364 days. By senior, we understand a patient over the age of 65.)
• Evaluate the protocol,
• When reaching the total of points corresponding to the development and development of malnutrition associated with the disease or other condition leading to an imbalance between the intake of nutrition and nutritional needs of the organism indicates ambulatory enteral nutrition.
  
  

• In the case of a patient who has a nasogastric tube or percutaneous endoscopic or surgical gastrostomy or itsunostomy, The doctor may resorb the full diet for up to 31 days in return for payment from public health insurance according to the therapeutically recommended amount of dietary food, taking into account the patient's clinical condition indefinitely, according to the patient's clinical condition and nutritional needs.
  • It warns the patient that only the amount of dietary food belonging to him is fully or partially covered by public health insurance L8 limit referred to in section A list (e.g. D0531 NUTRISON ADVANCED PEPTISORB PO salt 1x1000 ml - 62 pcs). As he recommends a therapeutic dose of 74 pieces, he will be warned that he will have to pay 12 units in full or, in accordance with Section 88 (7) of the Act, will be given a medically justified application to the health insurance undertaking of the insured person for a specific method of reimbursement for the dietetic food included in the list which does not meet the quantitative limit (same procedure can be used if does not meet the indication or prescription limit).
  • Protocol 1 or 2 doctor initiating treatment (first indication)be based and maintained in the patient's medical documentation. For follow-up checks and transcriptions performed, the patient's health records shall be recorded in the patient's medical documentation.
  • In making the prediction, the doctor should be on the back of the prescription. recommended to mention forms of enteral nutrition (nutritional support or full enteral nutrition) Treatment Stage (initial treatment or continued treatment) or corresponding type of quantitative limit (L6, L7 or L8). This is recommended due to the smooth delivery of dietary food in a public pharmacy.

• In the case of a patient who does not have a nasogastric tube or percutaneous endoscopic or surgical gastrostomy or itsunostomy, The doctor may re-skirt him for payment from public health insurance nutritional support as follows:
  • Start initial therapy 14 days of prescription.

• consider the therapeutically recommended amount of dietary food, taking into account the clinical condition of the patient and warns him that only the amount of dietary food corresponding to dietary food is fully or partially covered by public health insurance L6 limit referred to in section A list (e.g. D0558 OSMERAL COMPLETE white chocolate p.o. salt. 1x470 ml - 15 pcs). As he recommends a therapeutic dose of 24 pieces, he will be warned that he will have to pay 9 units in full or in accordance with § 88 (7) of Act No. 363/2011 Coll., as a health care provider, to issue him a medically justified application to the health insurance undertaking of the insured person for a specific means of reimbursement for the dietetic food included in the list of categorised dietetic foods that do not meet the quantitative limit (indicative or prescription restriction).
• Protocol 1 or 2 doctor initiating treatment (first indication) be based and maintained in the patient's medical documentation. For follow-up checks and transcriptions carried out, medical records shall be kept in the patient's medical documentation.
• In making the prediction, the doctor should be on the back of the prescription. recommended to mention forms of enteral nutrition (nutritional support or full enteral nutrition) andTreatment Stage (initial treatment or continued treatment) or corresponding type of quantitative limit (L6, L7 or L8). This is recommended due to the smooth delivery of dietary food in a public pharmacy.
• Continued therapy -a condition of continued back-up treatment is an assessment of treatment tolerance and an assessment of the benefit of the treatment (body condition or weight stabilisation) documented in the patient's medical documentation after 14 days of initial treatment; continued treatment may be indicated and resorced for up to 31 days.
• The benefit of treatment must be assessed in the context of the underlying disease or condition and based on medical criteria. The patient must first tolerate the treatment well. Consequently, it must benefit physically and mentally, as demonstrated by, for example, stabilisation or improvement of its physical condition, stabilisation or weight gain, or laboratory parameters that take into account the balance between the intake of nutrition and nutritional needs of the organism. Stabilization of physical condition is assessed on an individual basis compared to the condition at the time of indication of treatment. The stabilization of physical condition means maintaining or improving the quality of life of the patient due to the physical and psychological abilities of his body.
• Nutritional support is covered by public health insurance a maximum of six months. After six months reimbursement of treatment is subject to prior approval by the health insurance undertaking. The process of approval of continued treatment of outpatient enteral nutrition will take place by default, as has been the case so far in infant formula or as is the case with medicinal products. On the website of the General Health Insurance Agency, the necessary forms are available for the approval of the treatment by the health insurance review physician as well as forms for the approval of individual treatment according to a specific method of payment (e.g. exemption from the prescription, indication limit or quantitative limit, non-categorized dietetic food...). Time limits for dealing with such applications are addressed by the Internal Insurance Directive (usually within 7 days if the application meets all the requirements).
• If treatment with nutritional support is interrupted (e.g. improvement after 3 months or the doctor does not ask the health insurance company for permission to extend the prescription after 6 months), the doctor may restart the initial nutrition support for 14 days and continue the same treatment procedure if there is evidence of a balance between the intake of nutrition and nutritional needs of the organism and the protocol recorded the development and development of malnutrition. The basic condition of ambulatory enteral nutrition covered by dietary treatment is to write and evaluate the protocol as well as its preservation in the patient's medical documentation.
• As with any other treatment procedure, dosing data and dose modification should be recorded in the patient's medical documentation.
• According to § 4 §. 3 of Law No 576/2004 Z. z. on health care, as amended, the doctor is obliged to provide health care correctly.
• Health care is provided correctly if all health performances are carried out to correctly identify the disease, ensuring timely and effective treatment with a view to healing the person or improving the condition of the person, taking into account current knowledge of medical science.
  
  
• In the case of a patient who does not have a nasogastric tube or percutaneous endoscopic or surgical gastrostomy or itsunostomy,on the basis of his state of health, he wants to indicate full nutrition in accordance with § 88 (7) of Act No. 363/2011 Coll. as a health care provider to write to the patient a medically justified application to the health insurance undertaking of the insured person for a specific method of reimbursement for dietetic food included in the list of categorised dietetic foods which does not comply with the indicative restriction.

IV. Patient on 1.7.2013 for continued treatment

• If the patient is already set for the treatment of dietary enteral nutrition foods, we recommend that the physician who indicated primary treatment should not interrupt. At the next patient's check-up, the doctor will write and base a protocol in the patient's medical documentation indicating in the section "clinical assessment of nutritional status" the reason why nutrition therapy has been indicated to the patient, how long it has been taken and will assess the benefit of treatment to date and justify the justification for continued treatment. Regardless of the duration of previous treatment, continued treatment (i.e. from 1.7.2013) may be continued, in full enteral nutrition resorcing as necessary; andnutritional support at most six months. After six months of nutritional support treatment, it is necessary to further prescribe the consent of the health insurance company. Prescribing shall take place for a maximum of 31 days. For follow-up checks and transcriptions carried out, medical records shall be kept in the patient's medical documentation.

• In making the prediction, the doctor should be on the back of the prescription. recommended to mention forms of enteral nutrition (nutritional support or full enteral nutrition) Treatment Stage (initial or continued therapy) or related type of quantitative limit (L6, L7 or L8). This is recommended due to the smooth delivery of dietary food in a public pharmacy.
• If nutritional therapy is discontinuedthe doctor may restart the initial nutrition support for 14 days and continue the same treatment procedure if there is evidence of a balance between the intake of nutrition and nutritional needs of the organism and the protocol recorded the development and development of malnutrition. The basic condition of ambulatory enteral nutrition covered by dietary treatment is to write and evaluate the protocol as well as its preservation in the patient's medical documentation.

II. Medicinal product subject to medical prescription for dietetic food enteral nutrition in a public pharmacy

• Medicinal under medical prescription.
• The doctor who completed the prescription in accordance with § 120 (2) of Act No. 362/2011 Coll. on medicinal products and medical devices as amended is responsible for the completeness and correctness of the completion of the prescription.
• Since only one of the forms of enteral nutrition and this nutritional support is covered by public health insurance for a maximum period of six months after the initial indication of treatment starts by writing protocol 1 or 2, which remains in the medical documentation of the physician who initiated the treatment, the period of reimbursement will be monitored by the review department of the health insurance company and the doctor who will reskirt the treatment.
• The holder of a medical care permit shall be entitled to dispense the dietary food in question to the patient on a prescription basis without the indicated consent of the health insurance undertaking.
• In making the prediction, the doctor should be on the back of the prescription. recommended to mention forms of enteral nutrition (nutritional support or full enteral nutrition) andTreatment Stage (initial treatment or continued treatment) or corresponding type of quantitative limit (L6, L7 or L8). This is recommended due to the smooth delivery of dietary food in a public pharmacy.