[1] In a case where the new medical technology assessment system was implemented after the enforcement date of the new medical technology assessment system ( April 28, 2007) and new medical technology was modified and the degree of modification was not insignificant and thus the same or similar is not recognized as being identical or similar to each other, whether new medical technology assessment should be done prior to the determination of whether the degree of modification is insignificant (affirmative), and matters to be considered when determining whether the degree of modification is insignificant

[2] In a case where Party A received individual charges from a patient who had been treated as an anti-psychotropic drugs in a convalescent hospital operated by itself, but the Health Insurance Review and Assessment Service confirmed and ordered refund of expenses incurred in performing anti-psychotropic drugs as “aggravated charge,” on the ground that “the application for new health technology is not prior to the existing category of pharmacological,” the case holding that the judgment below erred by misapprehending the legal principles on the premise that the above disposition was unlawful on the ground that the above disposition was not unlawful, on the ground that the modification was considerably different in the purpose, part, method, etc. of the procedure when compared with the existing medical technology, and that the degree of modification was not insignificant, and thus, it cannot be deemed as identical or similar with each other, and thus, it should be recognized as safe and effective through the new health technology assessment procedure that Party A would receive the payment of expenses incurred in performing cardio-psychotropic drugs as non-benefit items from the patient.

[1] In full view of the provisions of Article 53(1) and (2) of the Medical Service Act, Article 14 of the Addenda (amended by Ordinance of the Ministry of Health and Welfare, Article 2 subparag. 2 of the former Regulations on the Evaluation of New Medical Technology (amended by Ordinance of the Ministry of Health and Welfare, Sept. 21, 2015), etc., where a new medical technology newly sought after April 28, 2007 changed its existing medical technology in terms of the purpose, object, method, etc. of the new medical technology assessment system, and where the degree of change is not insignificant, the new medical technology assessment is subject to the new medical technology assessment, and it does not fall under non-benefit medical practice unless it is evaluated in accordance with the procedure of the relevant Act and subordinate statutes. Determination of whether the degree of change is insignificant, the purport of the new medical technology assessment system ought to be taken into account by providing for matters necessary for national medical fees so that all citizens can benefit from high-quality medical treatment, thereby ensuring the safety and effectiveness of the medical service system.

[2] In a case where Party A received KRW 9,200,00 from a patient who received treatment of psychotropic drugs, etc. in a convalescent hospital operated by itself, but the Health Insurance Review and Assessment Service confirmed expenses for psychotropic surgery as “multi-closion charge,” and ordered refund of the aforementioned expenses on the ground that “the application for new medical technology should not be prior to the application for treatment because the psychotropic surgery does not fall under the category of the existing non-medical practice under the National Health Insurance Act,” the case holding that the judgment below erred in the misapprehension of legal principles on the premise that the psychotropic surgery is not identical or similar to the pre-determined treatment procedure, on the grounds that the psychotropic surgery is a medical technology that maximizes treatment effect by inserting a small quantity of drugs, which is the core treatment technology of oriental medicine, and thus, it cannot be seen that the psychotropic surgery is identical or similar to the pre-determined treatment procedure, on the ground that there is no substantial difference between the pre-determined treatment procedure and the pre-determined treatment procedure.

[1] Article 53(1) and (2) of the Medical Service Act; Article 2 subparag. 2 (see current Article 2(1)3) of the former Regulations on the Evaluation of New Medical Technology (Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sept. 21, 2015) / [2] Articles 47 and 48 of the National Health Insurance Act; Article 53(1) and (2) of the Medical Service Act; Article 2 subparag. 2 (see current Article 2(1)3) of the former Regulations on the Evaluation of New Medical Technology (Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015)

Plaintiff (Attorney Yoon Young-young et al., Counsel for the plaintiff-appellant)

Attached 1 List of Intervenor joining the Plaintiff is as shown in the List of Intervenor joining the Plaintiff (Law Firm LLC et al., Counsel for the plaintiff-appellant)

The Health Insurance Review and Assessment Service (Law Firm Pyeongan et al., Counsel for the defendant-appellant)

[Attachment 2] List of Intervenor joining the Defendant (Law Firm Sung, Attorneys Kim J-hee et al., Counsel for the defendant-appellant)

Seoul High Court Decision 2015Nu41229 decided January 26, 2016

The lower judgment is reversed, and the case is remanded to the Seoul High Court. The Plaintiff’s Intervenor and Defendant’s Intervenor’s Intervenor’s motion to intervene in the case is dismissed. The litigation cost incurred from the intervention is assessed against the Plaintiff’s Intervenor and Defendant’s Intervenor respectively.

The grounds of appeal are examined.

1. Case summary

According to the reasoning of the first instance judgment cited by the lower court and the record, the following facts are revealed.

The Plaintiff received KRW 9,200,000 from a patient who received treatment of anti-patient drugs in a convalescent hospital run by himself/herself.

On March 14, 2014, the Defendant issued the instant disposition to confirm and order refund of the cost of psychotropic drugs as “the cost of psychotropic drugs 9,200,000 won,” on the ground that “The treatment principle and method of psychotropic drugs do not fall under the existing category of pharmacological treatment by injecting drugs into serum and treating them in consideration of traditional treatment method, and the application for new medical technology must be prior to the application.”

Accordingly, the Plaintiff filed the instant lawsuit seeking revocation of the instant disposition, alleging that the blood scamcam is included in the scope of pharmacologicals listed as non-benefit items in the table and relative value points of health insurance benefit and non-health insurance benefit (Notice of the Ministry of Health and Welfare No. 2010-123, hereinafter “Notification of the instant case”).

2. Determination on grounds of appeal Nos. 2 and 3

A. Relevant statutes

(1) According to Article 53(1) and (2) of the Medical Service Act, Article 2 subparag. 2 of the former Regulations on the Evaluation of New Health Technology (amended by Ordinance of the Ministry of Health and Welfare No. 353, Sept. 21, 2015), the Minister of Health and Welfare shall conduct an evaluation of the safety, effectiveness, etc. of new health technology (hereinafter “evaluation of new health technology”) through a deliberation by the Committee on Evaluation of New Health Technology in order to protect national health and promote the development of health technology. In this case, the said evaluation of new health technology requires an evaluation of the safety and effectiveness of new health technology as newly developed health technology. The said evaluation of new health technology is also subject to the evaluation of new health technology that the Minister of Health and Welfare recognizes as necessary to assess its safety and effectiveness.

(2) The new medical technology assessment system was introduced through the amendment of the Medical Service Act by Act No. 8067 on October 27, 2006 and enforced on April 28, 2007. Article 14 of the Addenda of the Medical Service Act amended by Act No. 8366 on April 11, 2007 provides that medical practice (including non-benefit medical practice) included in the details of medical care benefit determined by the Minister of Health and Welfare under Article 42(4) of the National Health Insurance Act as of April 28, 2007, which was the enforcement date of the partially amended Medical Service Act (Act No. 8067), shall be deemed to have undergone new medical technology assessment in accordance with the amended provisions of Article 53.

Pursuant to the National Health Insurance Act on January 28, 2001, it became the subject of health care benefit under the National Health Insurance Act from January 2006 to non-benefit items. Accordingly, it is deemed that it constitutes non-benefit medical practice under the National Health Insurance Act at the time of April 28, 2007, which was the enforcement date of the new health care assessment system under Article 14 of the Addenda to the above revised Medical Service Act, and thus, it is deemed that it was subject to new health care assessment under Article 53 of the Medical Service Act.

B. (1) Medical practice refers to the act of preventing or treating diseases caused by diagnosis, diagnosis, prescription, medication, or surgical surgery with medical expertise as a result and function based on medical expertise, and other act that may cause harm to public health and sanitation if performed by a medical practitioner (see Supreme Court Decision 2004Do3405, Oct. 28, 2004, etc.). Therefore, medical practice provided for medical practice should be based on the experience and function based on medical expertise, and medical safety and effectiveness should be equipped.

(2) Pursuant to Article 14 of the Addenda to the above amended Medical Service Act, a newly developed medical technology assessment need not be conducted, deeming that the existing medical technology has already been subject to safety and effectiveness verification (see Supreme Court Decision 2011Do8694, Sept. 13, 2012). Therefore, the safety and effectiveness of a newly developed medical technology should be verified through a new medical technology assessment procedure with respect to which its safety and effectiveness have not been verified (see Supreme Court Decision 201Do8694, Sept. 13, 2012).

(3) In full view of the provisions of the relevant laws and regulations as seen earlier, if a new medical technology, which was attempted after April 28, 2007, was modified in the purpose, object, and method of the procedure, etc., and the degree of modification is not insignificant, and thus, if it is not deemed identical or similar, it shall be subject to the new medical technology assessment, and if it is no longer recognized as identical or similar, it shall be subject to the new medical technology assessment. In determining whether the degree of modification is minor, the legislative purport of the new medical technology assessment system, which seeks to protect and promote the health of the people, should be considered by providing for necessary matters for the public’s fee so that all citizens can benefit from high-quality medical care.

Therefore, even in this case, if the blood beeral beeral beeral is identical or similar to the medicinal beeral beeral beeral being listed as non-benefit items in the instant notice, it can not be deemed that the degree of change from the pharmacological is minor without undergoing new health technology evaluation.

C. Examining the reasoning of the lower judgment and the circumstances revealed in the evidence duly admitted by the lower court in light of the relevant statutes and the legal doctrine as seen earlier, it is reasonable to view that the scope of the alteration of the procedure is identical or similar inasmuch as there is considerable difference in the purpose, condition, method, etc. of treatment compared to the pre-existing medical technology, and the degree of the alteration thereof is not insignificant. Therefore, it is reasonable to deem that the safety and effectiveness should be recognized through the procedures for new medical technology assessment that the Plaintiff is entitled to the payment of the expenses incurred in connection with the re-treatment from the re-explosives as non-benefit items. The detailed

(1) Pharmacologic surgery is administered around 0.1 to malml before and after the body reaction points to maximize the effects of aggression and herb treatment on the basis of an adjudication theory (a method of treating diseases by transmitting physical stimulations through successful bid and light blood) which is an adjudication theory, which is the theory of bedclothes unique to oriental medicine (a method of treating diseases by transmitting the physical stimulations through competitive bid and light blood transfusion). The relevant textbook explains that balone surgery is injected into a form of damage to blood, etc.

(2) Blood domination is explained to be the method of treating diseases by inserting the drugs refined and extracted from mountain ginseng, etc. into blood, etc., and is also introduced as “sancincincincincincinc incinc incinc incinc incinc incinc incinc inc incinc inc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc incinc

(3) Therefore, inasmuch as it is a medical technology that maximizes treatment effects by inserting a small quantity of drugs by using a small quantity of drugs, which are the core treatment technology of oriental medicine, inculpting the bedclothes and the Pharmaceutical Products Act, it is based on the Bedcing Act premised on the Bedcing Act. However, blood beculptism is a procedure that has no, or is very weak, the effect of culpting, or maximizes the effect of drugs solely.

D. Nevertheless, the lower court determined that the instant disposition was unlawful on the ground that the instant disposition was unlawful on the grounds that the blood beer is not inherently different from the pharmacological, and that the assessment of new medical technology cannot be deemed prior to being paid by the winners. In so determining, the lower court erred by misapprehending the legal doctrine on the new medical technology assessment system under the Medical Service Act, thereby adversely affecting the conclusion of the judgment. The allegation contained in the grounds of appeal on

3. Determination as to whether the Plaintiff’s Intervenor and the Defendant’s Intervenor’s motion to intervene in the case is lawful

In order to intervene in a specific litigation case in order to assist one of the parties, there must be an interest in the result of the relevant litigation, and the term "interest" refers to a legal interest, not in fact, in economic or emotional interests, but in legal interests (see Supreme Court Decision 9Da26924 delivered on September 8, 200, etc.).

The interest claimed by the Plaintiff’s Intervenor and the Defendant’s Intervenor cannot be deemed as a legal interest in the outcome of the instant lawsuit. Therefore, the Plaintiff’s Intervenor’s motion for intervention is unlawful on the grounds that it does not meet the requirements for intervention.

4. Conclusion

Therefore, without further proceeding to decide on the remaining grounds of appeal, the lower judgment is reversed, and the case is remanded to the lower court for further proceedings consistent with this Opinion. All of the Intervenors and Defendant Intervenors’ motion to intervene in the case are dismissed, and the litigation cost incurred by the intervention is borne by the Plaintiff’s Intervenors and Defendant’s Intervenors, respectively. It is so decided as per Disposition by the assent of all participating Justices

[Attachment 1] List of Intervenors joining the Plaintiff: Omitted

[Attachment 2] List of Intervenors joining the Defendant: Omitted

Justices Jo Hee-de (Presiding Justice)