26.Standard for Inspection of Medical Care Claims Billing Software

[22-2(B) KCCR 150, 2008Hun-Ma408, October 28, 2010]

In this case, the Court upheld Article 3 subparagraph 5 and Article 4 Section 1 of the Standard for Inspection of Medical Care Claims Billing Software, which requires medical care institutions to use a medical care claims billing software package containing an electronic prescribing software program and the doctors to file, in real time, reasons for prescribing contraindicated drugs to the Health Insurance Review and Assessment Service, stating that they do not infringe on the complainants' freedom of occupation and does not go beyond the constitutional limits of delegated legislation.

Background of the Case

1.The complainants are those who have obtained doctor's licenses, and the remaining complainants are those who have operated medical care institutions from March 13, 1985 to December 26, 2007.

2.On December 17, 2007, the Minister of Health and Welfare revised the Standard for Inspection of Medical Care Claims Billing Software, under which the representative of a medical care institution has to use a billing software package that involves an electronic prescribing software program (hereinafter the "prescribing software"). The required features of the billing software package are: daily receipt of information provided by the central management system of the Health Insurance Review and Assessment Service (hereinafter the "Review and Assessment Service"); warning message prompt service associated with contraindications such as age or combined use of drugs; and real time transmission, using the public key certificate, of the records of prescribed contraindicated drugs on the contrary to the warning message on the screen.

3.The complainants filed the constitutional complaint in this case

on May 23, 2008, arguing that the aforementioned Standard violates their freedom of occupation.

Provisions at Issue

Standard for Inspection of Medical Care Claims Billing Software (Amended by Notification No. 2007-120 of Ministry of Health and Welfare, Dec. 17, 2007)

Article 3 (Scope of Inspection)

The scope of inspection of the medical care claims billing software requested by the representative (of the billing software provider or the medical care institution) pursuant to Article 2 shall include the following subparagraphs: Provided, that subparagraph 5 shall be excluded from the inspection of the billing software package used by herbal medical care institutions, and inspection of self-developed billing software used by hospital-level medical care institutions only requires that of the following subparagraph 5:

5. Function of the prescribing software program

Standard for Inspection of Medical Care Claims Billing Software (Amended by Notification No. 2008-6 of Ministry of Health and Welfare, Mar. 27, 2008)

Article 4 (Requirements, etc. for Prescribing Software Programs)

(1)The prescribing software program provided by Article 3 subparagraph 5 shall:

1.Have daily access to information provided by the central management system of the Health Insurance Review and Assessment Service (hereinafter "Review and Assessment Service") and be able to engage in real-time exchange of materials with the system.

2.Provide message prompts for failure processing and analysis and offer log management functions.

3.Provide warning messages on the computer screen regarding medical safety, such as contraindications of age or combined use of drugs and suspension of supply, and display information, also on the screen, which is specifically defined by the Minister of Health and Welfare such as low and high content medication for management of

low content composition of drugs in prescription. In this case, if prescription of drugs related to the aforementioned medical safety is filled for inevitable reasons, the feature of warning message prompts shall be activated to notify the reasons for such prescription filling.

4.Transmit, in case prescriptions are filled, along with reasons as specified in the latter portion of subparagraph 3, despite the warning message prompted on the screen pursuant to the former portion of subparagraph 3, the information of the prescribed medicine in real time to the central prescription management system administered by the Review and Assessment Service in an encoded form using the public key certificate. Provided, that if the medical care institution is unable to transmit the information about the prescribed medicine in real time due to internet connection or other systematic problems, all relevant information shall be gathered and sent daily as a package or can be submitted via other methods such as fax or mail.

5.Specify, in case of prescription filling despite the warning message prompted on the screen pursuant to the former portion of subparagraph 3, the name of the contraindicated drugs and information about them in the prescription as provided in medical laws or send a document containing that information to patients.

Summary of the Decision

I. Legal Issues of the Case

At issue in this case is the constitutionality of the provisions of the Standard for Inspection of Medical Care Claims Billing Software (hereinafter the "provisions of the Standard") which, among others, require medical care institutions to use a billing software package containing a prescribing software program and doctors to transmit in real time the reasons for filling prescription of contraindicated drugs, using functions of the prescribing software, to the Review and Assessment Service and which, therefore, may have violated the fundamental rights of the complainants, who are representatives of medical care institutions and doctors.

II.Whether Provisions of the Standard Violates the Complainants' Freedom of Occupation

A.Whether provisions of the Standard restricts the freedom of occupation

In accordance with the provisions of the Standard, doctors are required to receive the information provided by the central management system of the Review and Assessment Service on a daily basis, transmit medical information to the Review and Assessment Service in real time in case of filling prescription of contraindicated drugs despite contraindications such as age, combined use of medicine, or suspension of supply as notified in warning messages on the computer screen and to specify the relevant medical information on prescriptions or send documents containing such information to patients. Consequently, doctors thus have their right to prescribe drugs restricted, and the provisions of the Standard regulate their freedom of occupation.

B. Whether provisions of the Standard violates the principle against excessive restriction

1.The purpose of the provisions of the Standard lies in preventing harmful health effects that may occur from inappropriate prescribing of drugs and in improving and streamlining medical finances through adequate prescription of doctors by a) contributing to the protection of public health by offering information in real time to certain institutions of medical care, b) discouraging medical care institutions from using contraindicated drugs by prompting warning messages in case of prescribing such drugs and thus encouraging appropriate prescription and c) improving medical finances through more appropriate prescription by doctors. As the provisions of the Standard aim to contribute to public welfare, they have a legitimate purpose.

2.To control prescription filling of contraindicated drugs and protect patients' health, it is insufficient to provide doctors with only the information on contraindicated drugs in advance and, based on ex post

facto review, lowering the medical care claims. Rather, it would be more effective to forestall such prescription in the first place by warning the doctors in real time with all such information related to prescribing contraindicated drugs. In this regard, the provisions of the Standard intend to inform doctors of contraindications in real time and, in case of filling prescriptions against such conditions for withholding a certain medical treatment, instantly notify the patients and the Review and Assessment Service of such an act, thereby keeping doctors' prescription filling of contraindicated drugs under control. In this sense, the provisions of the Standard qualify as an adequate means to serve the legislative purpose.

3.Under the current drug utilization review system centered on ex post facto review, control of the prescription filling of contraindicated drugs has been ineffective. However, the drug utilization review remedied by the provisions of the Standard requires that doctors transmit the details and reasons for prescribing contraindicated drugs in real time and inform patients of the reasons for such prescription filling, which aims at reviewing and controlling the prescription filling of contraindicated drugs in advance and effectively preventing patients from taking contraindicated drugs. This method of prior control is effective in achieving the legislative purpose of the provisions of the Standard, and there appears to be no evident and less restrictive means. Therefore, the provisions are not in violation of the least restrictive means.

4.The provisions of the Standard restrict the complainants' rights to prescribe drugs and thus the freedom of occupation by requiring doctors to specify reasons for filling the prescription of contraindicated drugs and transmit that information to the Review and Assessment Service in real time. However, this is not a total ban on the prescription of contraindicated drugs but permission conditional on provision of reasons for such prescription filling. Therefore, the restriction on doctors' freedom of occupation is not overly excessive. Meanwhile, implementation of a drug utilization review system improved by the provisions of the Standard will discourage doctors from prescribing contraindicated drugs in advance, protect the health of

patients by preventing their use of contraindicated drugs and even reduce unnecessary medical costs. In this regard, the resulting significance and impact of the public interest would be huge. If so, restriction of occupational freedom imposed on the complainants by the provisions of the Standard is not inconsistent with the principle of balance of interests.

5.In conclusion, the provisions of the Standard do not violate the complainants' freedom of occupation as they are not contrary to the principle of proportionality.

III.Whether Provisions of the Standard Go Beyond the Limits of Delegated Legislation

A.Article 28 Section 1 subparagraph 1 and Section 2 of the Enforcement Decree of the National Health Insurance Act define operations of the Review and Assessment Service as computer processing, such as inspection, etc. of software related to request for review of medical care benefits, but the provisions of the Standard stipulate the details of the software related to prescribing drugs. In that sense, the aforementioned provisions of the Enforcement Decree may not be characterized as a parent or enabling act of the provisions of the Standard.

B.Yet, Article 56 Section 1 subparagraph 2 of the National Health Insurance Act sets forth "evaluation of the reasonableness of medical care benefits," and subparagraph 7 of the Act stipulates "other operations prescribed by Presidential Decree in connection with review of the costs of insurance benefits and evaluation of the reasonableness of insurance benefits" as operations of the Review and Assessment Service. At the same time, Article 56 Section 2 of the Act provides that "The criteria, procedures, and methods relevant to the evaluation of the reasonableness of medical care benefits as referred to in paragraph (1) 2, 5 and 7, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health, Welfare and Family Affairs." Also, Article 83 Section 1 of the same Act provides that the Review and Assessment Service may request medical care

institutions to furnish the materials that are necessary for the health insurance program.

In addition, Article 28 Section 1 subparagraph 1 of the Enforcement Decree of the Act stipulates "computer processing, such as development, supply, inspection, etc. of software related to a request for the review of medical care benefits under Article 43 of the Act" as part of the "operations prescribed by Presidential Decree" as provided in Article 56 Section (1) 7 of the Act. At the same time, Section 2 of the Act provides that "the scope of and procedures for computer processing under paragraph (1) 1 and other necessary matters shall be determined and notified by the Minister of Health and Welfare."

In addition, Article 21 Section 1 of the Enforcement Rule of the National Health Insurance Act provides that "In case the Review and Assessment Service evaluates the reasonableness of medical care benefits, the criteria for evaluation should include medical science and cost effectiveness, and the results of evaluation should be made public." Also, Section 3 of the same Article stipulates that "Other criteria, procedures, and methods relevant to detailed evaluation of the reasonableness of medical care benefits shall be prescribed and notified by the Minister of Health and Welfare and Family Affairs."

C.According to organized and systematic review of relevant provisions such as the National Health Insurance Act and its Enforcement Decree, the Review and Assessment Service is empowered to review the costs of medical care benefits, evaluate the reasonableness of the benefits and request necessary materials from medical care institutions. Detailed procedures and methods in this regard can be decided and notified by the Minister of Health, Welfare and Family Affairs.

In reviewing whether or not to pay the medical care claims, however, the reasonableness of medical care benefits concerned should be evaluated first and then that of the billed claims for the medical care benefits should be judged later. Therefore, the software package

related to the request for review of medical care benefits may include the function of evaluating the reasonableness of the benefits, and incorporating such evaluative function into the billing software program does not mean that a feature irrelevant to the review of medical care benefits costs has been included.

In this case, the prescribing software program as prescribed by the provisions of the Standard enables the instant transmission of information related to contraindicated drugs and control of prescribing contraindicated drugs through immediate warning. This procedure can be equated with the work of evaluating the reasonableness of medical care benefits and collecting relevant information and is also a necessity for review of claims for medical care benefits.

Therefore, the provisions of the Standard have been stipulated within the limits of powers granted by the following enabling statutes: subparagraph 1, 2 and 7 of Article 56 Section 1, Article 56 Section 2, Article 83 Section 1 of the National Health Insurance Act, Article 28 Section 1 subparagraph 1 of the Enforcement Decree of the Act and Article 21 Section 1 and 2 of the Enforcement Rule of the Act. For this reason, the provisions of the Standard have not gone beyond the limits of delegated legislation.