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UDC 616:34.03
IMPLEMENTATION OF CLINICAL GUIDELINES (TREATMENT PROTOCOLS), THEIR LEGAL STATUS AND LAW CONTRADICTIONS
1 Altai State Medical University, Barnaul
2 Research Institute of Complex Hygiene Problems and Professional Diseases, Novokuznetsk V.B.Kolyado1, S.I. Tribunsky1, E.V.Kolyado12
There is presented the review of the regulatory and legal framework in terms of implementation of clinical guidelines (treatment protocols) by medical organizations. There are stated the problems and law contradictions which can be the basis for litigation of particular statements of their application.
Key words: clinical guidelines (treatment protocols), law contradictions, quality of medical care.
Qualitative legal and regulatory framework of any type of activity is the basis of professional activity both of government institutions providing central and local services and particular natural and legal persons performing medical activity [15]. In conditions, when practically all offences lead to massive penal fines on the part of supervisory bodies, this statement becomes especially important.
On the 26th of August 2015, the media center of Rossiyskaya Gazeta held the press-conference with the participation of the Minister of Health of the RF, where it was stated, that "one of the main directions of activity of the Ministry of Health is the creation of system of quality assurance of medical service. Since the end of 2012, for the first time in our new history, we have been creating the pool of national clinical protocols-guidelines. Now there are already created protocols for 4000 codes ICD-10 for more than 90% of pathological conditions causing morbidity in our country" [6].
The electronic resource "Federal electronic medical library" (www.femb.ru @ all bases @ clinical guidelines) as of 01.03.2017 contains only 1202 clinical guidelines (treatment protocols) out of 4000 mentioned by the minister.
Let us consider the issues and law contradictions of clinical guidelines (protocols) implementation by carrying out medical activity.
According to part 1 of article 37 of the federal Law of 21.11.2011 №323-FZ "On the basis for health protection in the Russian Federation", medical service is organized and provided in accordance with the rules of healthcare delivery binding in the territory of the Russian federation on all medical organizations, and also on the basis of standards of medical health except for the medical health provided in terms of clinical testing. However, in the period of 2015-2016, after the introduction of alterations or upon issuing of new statutes and regulations of the Ministry of Health of the Russian Federation and Federal Statutory Health Insurance Fund, some documents, along with standards and regulations, included enumeration of clinical guidelines (protocols) as documents obligatory for implementation
by performing medical activity, which prompted a number of questions.
By studying the documents, all experts immediately noted insufficiency or lack of requisite details of these clinical guidelines (protocols), lack of registration in the Justice Ministry of the Russian Federation, lack of data on their official issuing (date of issue, source).
According to paragraph 9 of the RF Government Regulation of 13.08.1997 №1009 "On approval of Regulations on the preparation of normative legal acts of federal executive authorities and their official registration", the executed normative legal act should have the following requisite details: name of the authority (authorities) executed the act; type of the act and its name; date of signing (approval) of the act and its number; name of official capacity and surname of the person signed the act.
Paragraph 2 part 1 of the Decree of the Justice Ministry of the Russian Federation of 04.05.2007 № 88 "On the approval of the explanations on the application of the rules for the preparation of normative legal acts of the federal bodies of executive power and their state registration" affirmed, that normative legal acts of federal executive authorities are issued only in forms of resolutions, decrees, regulations, rules, guidelines and provisions. Acts issued in other forms (for example, directions, etc.) cannot be of normative legal nature. Issuance of acts in the form of letters and telegrams is not allowed. Structural divisions and territorial bodies of federal executive authorities are not authorized to issue normative legal acts.
According to part 3 of article 15 of the RF constitution, all laws and all normative acts concerning human rights, freedoms and duties have to be offi-dally published for general public. Nonpublished normative legal acts which has not yet become effective in law lie dormant, have no tangible consequences. Official publication is the constitutional guarantee of civil rights. To determine since which moment an NLA goes into effect, it is necessary to understand, which is official publication and which conditions should be observed.
Publication of NLA in a popular edition possesses the status of official publication only when the edition is legislated as the official source of the stated NLA type publication. Moreover, NLA must be fully published in the official edition ("KonsultantPlyus"). Thus, official publication of NLA is the placement of full text of the document in special editions recognized by the official active legislation.
Part 2 of article 76 of the federal law of 21.11.2011 № 323-FZ "On principles of the health of citizens in the Russian Federation" determined, that clinical guidelines (treatment protocols), including consideration of clinical approbation results, on healthcare provision are elaborated and approved by medical professional non-commercial organizations.
Due to the lack of the approved list of medical professional non-commercial organizations (medical professional associations and societies) eligible for the elaboration and approval of clinical guidelines (treatment protocols) any medical professional association or society is allowed to elaborate and approve these documents.
At the present time, for numerous medical specializations there are simultaneously functioning over ten medical professional associations or societies, consequently, for one and the same nosology, there could be elaborated and approved over ten types of clinical guidelines (treatment protocols) considering various opinions of clinical and scientific schools sometimes considerably differing in views and approaches to diagnosis, treatment and rehabilitation.
According to p.9 of the Resolution of Plenum of the Supreme Court of the Russian Federation of 29.11.2007 №48 "On the practice of court cases challenging the normative legal acts in the whole or partially", a normative legal act - is a document issued in accordance with the established procedure by the competent public authority, local government body or administrative official, containing legal norms (rules of conduct) obligatory for indefinite range of persons, intended for non-expendable implementation, directed at the adjustment of social relations, change or termination of the existing ones. Normative legal acts (in contradiction to other legal sources) are accepted only by competent public authorities within the range of their expertise, possess a particular form and are presented as documents (are formed according to the rules of legal writing).
Thus, clinical guidelines (treatment protocols) elaborated and approved by medical professional non-commercial organizations are not normative legal acts and the liability of their implementation is disputable.
At the same time, in 2015-2016, there were issued new documents - decrees of the Ministry and the Federal Compulsory Medical Insurance
Fund, which include direct links to clinical guidelines (protocols) and the obligation of their performance in medical organizations by medical activity.
On 01.07.2017, there came into effect the Decree of the Ministry of Health of the Russian Federation of 15.07.2016 № 520n «On the approval of medical service quality assessment criteria", which was issued in accordance with part 2 of article 64 of the federal Law of 21.11.2011 № 323-FZ "On the basis for health protection in the Russian Federation".
Thus, the criteria for the evaluation of medical service quality enumerated in article 2.1 of Decree №520n include: a) determination of clinical diagnosis on the basis of anamnesis, examination, data of laboratory, instrumental and other means of research, results of specialised medical consultations provided by standards of medical service and also clinical guidelines (treatment protocols); b) correction of examination and treatment plan considering the clinical diagnosis, patient's state, peculiarities of the disease course, presence of concomitant diseases, complications and results of the conducted treatment based on the standards of medical service and clinical guidelines (treatment protocols);
The criteria for the evaluation of medical service quality enumerated in article 2.1 of Decree №520n include: c) determination of clinical diagnosis on the basis of anamnesis, examination, data of laboratory, instrumental and other means of research, results of specialised medical consultations provided by standards of medical service and also clinical guidelines (treatment protocols).
In 2015, the Decree of the Federal Compulsory Medical Insurance Fund of 01.12.2010 № 230 "About the statement of the Order of the organization and monitoring procedure of volumes, terms, quality and conditions of granting medical care on obligatory medical insurance" was subject to a number of changes, according to which, the non-fulfilment of clinical guidelines (treatment protocols) is considered the failure of medical service and is included into the list of backgrounds for refusal of medical service payment (or reduction of payment).
For example, alterations were introduced into article 21 of Decree №230 - "Expertise of the medical service quality is performed by means of inspection of compliance of medical service provided to the insured person with the contract for healthcare delivery and payment, procedure of healthcare delivery and standards of health service, clinical guidelines (treatment protocols) on issues of healthcare delivery, accepted clinical practice (revision of the Decree of the Federal Compulsory Medical Insurance Fund of 21.07.2015 № 130)".
Into article 67 - "Failures of medical service and/or violations by healthcare delivery: non-fulfilment, late or improper fulfillment of required
or fulfillment of clinically non-justified diagnostic and (or) treatment procedures, surgeries in accordance with procedure of health service delivery, standards of medical service and (or) clinical guidelines (treatment protocols) on issues of healthcare delivery or pre-term termination of treatment service performance by the lack of clinical effect... (the paragraph is introduced by the Decree of the Federal Compulsory Medical Insurance Fund 21.07.2015 № 130)".
Into article 80 - "Basic functions of the expert are: a) random inspection of medical service amount for insurance event by means of correlation of factual data on performed medical service with procedures of medical service delivery and standards of medical service, clinical guidelines (treatment protocols) on issues of healthcare delivery (revision of the Decree of the Federal Compulsory Medical Insurance Fund of 21.07.2015 № 130)".
Into Appendix 8 of the Decree №230 "List of background for refusal of medical service payment (reduction of medical service payment) into article 1.5. - "Purchase of medicinal drugs and/or medical devices by patient or by person act in the interests of patient during the period of hospital stay on doctor's orders, included into the "List of vital and essential medicines", agreed upon and approved in accordance with the established procedure; on the basis of standards of medical service, clinical guidelines (treatment protocols) on issues of healthcare delivery; into article 3.2. - "Non-fulfilment, late or improper fulfillment of required or fulfillment of clinically non-justified diagnostic and (or) treatment procedures, surgeries in accordance with procedure of health service delivery, standards of medical service and (or) clinical guidelines (treatment protocols) on issues of healthcare delivery revision of the Decree of the Federal Compulsory Medical Insurance Fund of 21.07.2015 № 130)".
Consequently, there has been created the situation, when medical organizations were obliged by current normative legal acts registered by the Ministry of Justice of the Russian Federation to execute documents not referred to normative legal acts. The detected problems and legal contradictions of the status of clinical guidelines (treatment protocols) can serve as the background for challenging of some statements of their implementation in court.
References
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2. Kolyado E.V., Lazarev V.S., Perfilyev A.A. Substantiation of the necessity of perfection of normative-legal regulation of licensing of medical activity. Siberian medical journal. 2013; 8: 140-143.
3. Kolyado E.V., Perfilyev A.A., Lazarev V.S., Leshchenko V.A., Batrak Yu.M. Substantial changes in working law in the field of medical advertising. Siberian medical journal. 2014; 3: 110-112.
4. Kolyado E.V., Lazarev V.S., Perfilyev A.A. Characteristics of administrative offences discovered in the course of licensing supervision of healthcare and pharmaceutical organizations. Siberian medical journal. 2013; 4: 140-143.
5. Saldan I.P., Kolyado E.V., Perfilyev A.A., Lazarev V.S. Dynamics of administrative law infringements detected by the Altai Krai central department of public health care and pharmaceuticals within the scope of licensing supervision for the years 2011-2014. Siberian medical journal (Irkustk). 2015; 8: 38-42.
Contacts
Corresponding author: Tribunsky Sergey Iva-novich, Doctor of Medical Sciences, Professor of the Department of Public Health Care, Altai State Medical University, Barnaul. 656038, Barnaul, pr. Komsomolsky, 82. Tel.: (3852) 566-889. E-mail: tribunskiysi@mail.ru
Kolyado Vladimir Borisovich, Doctor of Medical Sciences, Professor, Head of the Department of Public Health Care, Altai State Medical University, Barnaul.
656038, Barnaul, pr. Komsomolsky, 82. Tel.: (3852) 566-889. E-mail: ozizagmu@agmu.ru
Kolyado Yelena Vladimirovna, Candidate of Medical Sciences, Associate Professor of the Department of Public Health Care, Altai State Medical University, Barnaul.
656038, Barnaul, pr. Komsomolsky, 82.
Tel.: (3852) 566-889.
E-mail: centrlicmed@inbox.ru
