What are the major systems of the MOHW, the MFDS, & the KCDA

in the new year

The government unveiled a system that will change in 2021

COVID-19 product development·Enhance safety

From next year, medical expenses for rare diseases and diseases subject to the exempted calculation will be expanded.

 

In addition, the national infrastructure necessary for rapid introduction and verification of the safety and effectiveness of COVID-19 vaccines and treatments using high-tech new technologies will be expanded.

 

The Ministry of Economy and Finance announced on the morning of the 28th a summary of the government's business plan for 2021, which will have a great impact on the public among all government ministry projects next year.

 

In the health care and pharmaceutical industry sectors, reinforcement of coverage for rare and essential targets and reduction of entry into essential medical care and advanced and precision technologies are typical.

 

◆Ministry of Health and Welfare = Diseases subject to the exempted calculation of health insurance will be expanded from January.

 

The exempted calculation is a type of guarantee that reduces the estimated copayment rate to 10%.

 

The targets for promotion are patients with severe incurable diseases, rare diseases such as keratoconus patients, or 68 rare diseases such as hydranencephaly and severe atopic dermatitis.

 

Newly designated as a disease subject to exempted calculation.

 

For these diseases, the current hospitalization co-pay rate is 20% and the outpatient co-pay rate is 30-60%, and from next month, the inpatient and outpatient co-pay rates will be 10%.

 

In August 2017, health insurance coverage for chest (breast) and echocardiography will be expanded according to measures to strengthen health insurance coverage.

 

The MOHW will expand and apply echocardiography in order from the first half of next year to the chest (breast) and from the second half of next year.

 

Until now, the government has completed health insurance coverage.

 

Beginning with the upper abdomen in April 2018, ultrasound examinations in the lower abdomen and the urinary system in February 2019, the emergency and critically ill patients in July of the same year, the male genitalia in September of the same year, the female genitalia in February this year, and the ophthalmology sector in September will be expanded.

 

In the meantime, despite the high cost-effectiveness of ultrasound, insurance has been applied mainly to patients with four major serious diseases (cancer, heart, cerebrovascular, rare intractable teeth) due to financial burden, but from now on, the disease is affected by the medical judgment of the doctor.

 

Health insurance benefit will be expanded if there is a need for examination due to a disease or suspected disease.

 

The government announced that it plans to discuss specific insurance coverage and medical cost reduction effects, and to prepare related legal procedures later with the medical community.

 

The government has been expanding responsible medical institutions in each region in order to close the gap in essential medical care between regions since last November.

 

This is a project to strengthen cooperation in essential medical services centered on public hospitals, focusing on 15 regionally responsible medical institutions such as national university hospitals, and 35 regionally responsible medical institutions such as local medical centers.

 

The main goal is to establish a system of direct and essential medical cooperation.

 

In addition, the business area in the essential medical field is expanded step by step to develop a cooperation model and carry out the project.

 

It also promotes referrals and transfers between partner organizations.

 

The MOHW is carrying out a project to revitalize medical referrals with the main focus of improving the reimbursement rate system so that exchange of medical information can be activated through an electronic method such as electronic record.

 

This is a method in which a medical institution in a non-capital region increases the fee when it is requested above the general hospital level (including specialized hospitals) in the same city.

 

As a result, the government is expecting to establish the function of each type of medical institution and to ease the focus of patients in large hospitals.

 

In addition, patient treatment and image information will be exchanged through an electronic method so that patient’s referrals can be made.

 

The government explained that this will increase patient safety by ensuring continuity of treatment at the time of referral and return, and increase patient convenience as patients do not have to submit treatment information directly.

 

In addition, it added that it is possible to expect efficient use of medical resources and savings in health insurance finances by reducing duplicate examinations and imaging.

 

In addition, the reimbursement rate system will be improved so that medical institutions in non-metropolitan areas can induce referrals to general hospitals, general hospitals, and specialized hospitals within the same city (17 administrative districts) to strengthen the connection of medical institutions within the local community.

 

A plan is also underway to shorten the period of entry into the medical field with new medical technologies through regulatory innovation of medical devices.

 

The MOHW expanded the targets for the evaluation of innovative medical technologies from last November so that cutting-edge medical technologies such as digital therapeutics and precision medicine can enter the medical field early.

 

Specifically, the number of innovative Health Technology evaluation targets has been expanded from 6 to 9, and the disease group, which was limited to 4 fields, has been abolished, enabling the use of advanced medical technology for various diseases with a large impact on society.

 

◆The KCDA = The KCDA will expand supportable diseases such as medical expenses for rare diseases from January next year.

 

The KCDA announced a list of additionally designated rare diseases in October this year, and plans to increase support for rare diseases such as medical expenses support and expansion of target diseases for diagnosis next year.

 

From January, the number of diseases subject to the medical expense support project for rare diseases has expanded from 1,014 to 1,078, supporting health insurance copayment.

 

In accordance with the designation of new rare diseases, the number of diseases subject to “genetic diagnosis support for rare diseases” will also be expanded from 126 to 175.

 

Online applications for medical expenses support for people with rare diseases will also be expanded.

 

The scope of the online application for the “medical expense support project for people with rare diseases,” which started in March this year, will be expanded from next September.

 

Specifically, it will expand from low-income health insurance subscribers who do not currently have a support obligation to all low-income household health insurance subscribers, medical benefit patients, and the next higher-ranking out-of-pocket patients who are eligible for deductible deductions regardless of whether they are obligated to support or not.

 

In addition, from next month, free vaccinations for the elderly pneumococcal (PPSV23) will be expanded from the current public health center to a consigned medical institution.

 

The government is temporarily expanding operation of vaccination institutions to consigned medical institutions from June 22 to the end of this year in response to COVID-19 by public health centers this year.

 

If it is expanded to entrusted medical institutions, about 14,000 sites will be added from 256 existing ones.

 

In addition, the KCDA strengthens the protection of personal information exposure of patients with infectious diseases.

 

In the event of an infectious disease crisis, personal information such as the name and detailed address of residence that are not related to the prevention of infectious disease should be excluded when disclosing the route of movement of the patient with an infectious disease.

 

This project will be applied from the 30th of this month.

 

◆The MFDS = The MFDS will support education and training to nurture experts in regulatory science to strengthen the safety supply of biohealth products and domestic industrial competitiveness from next year.

 

The government explained that it is essential to develop safety technologies that can evaluate product safety, effectiveness, quality and performance in order for biohealth products to which future technologies (AI, application of big data, etc.) are applied to the market quickly.

 

Accordingly, the MFDS will select five excellent universities in Korea and provide more than ₩500 million per year to each university for five years in order to cultivate professional researchers who research safety technology while learning legal knowledge about the licensing of biohealth products In addition, universities that have received applications are planning to cultivate more than 600 new researchers and field experts by establishing master's and doctoral degrees in regulatory science in the field of food and medicine at graduate schools.

 

Product development and safety management for COVID-19 will also be strengthened.

 

The MFDS is planning to reinforce infrastructure, such as verification of the safety and effectiveness of COVID-19 vaccines and treatments using state-of-the-art new technologies, and national testing equipment necessary for rapid domestic supply.

 

All vaccines, including the COVID-19 vaccine, must undergo a lot release from the MFDS after reviewing data on manufacturing and quality control and verification tests for domestic supply.

 

Accordingly, for the rapid and safe national lot release of COVID-19 vaccine, advanced analysis equipment will be added and newly introduced, and a special laboratory will be built.

 

In addition, in order to accelerate the development of a vaccine and treatment for COVID-19, the country plans to designate an “IRB” for rapid review.

 

It shortens the entry period for clinical trials by conducting an integrated review (one time) by IRB for approval of clinical trials conducted by various medical institutions.

 

To this end, the MFDS will regularly review major new information such as side effects of clinical trial drugs to prevent harm to patient safety in advance.

 

In addition, it will provide a platform that can be used for new drug development by transparently disclosing information from clinical trial approval to results, and release a lot of vaccines quickly and safely to successfully overcome COVID-19.

 

In addition, a design for the expansion of patient treatment opportunities and the rights, safety and welfare of clinical trial participants will be established.

 

Mandates education to prevent recidivism in people who commits a crime related to narcotics.

 

Since the 4th of this month, the MFDS has been convicted by a court or notified of a summary order as a mandatory education to prevent recidivism of people who commits a crime related to narcotics has been implemented.

 

The crime related to narcotics is a policy that compulsory completion of an order to attend education or rehabilitation programs necessary to prevent recidivism within 200 hours.

 

In addition, safety inspections for overseas direct purchases will be further expanded.

 

Even though the rate of nonconformity such as overseas fast-purchased food is very high, there are only about 1600 purchase inspections as of this year, and there is a possibility of domestic inflow of hazardous food, and the government inspects it at twice the level of the previous year (3,000 cases) from next year.

 

It plans to expand the number of cases.

 

In particular, the MFDS plans to reinforce the safety management of foods purchased directly from overseas by diversifying inspection targets such as foods of vulnerable groups and foods that are domestic issues from the existing tests focused on improving sexual function, strengthening muscles, and diet food.

 

The MFDS also implements an innovative medical device software manufacturing company certification system to promote rapid commercialization of innovative medical device software.

 

Innovative medical device software refers to a software-only product among medical devices with significantly improved safety and effectiveness compared to existing medical devices by applying advanced technologies such as artificial intelligence (AI) and virtual reality (VR).

 

When manufacturing licenses for innovative medical device software of certified companies, some of the submitted data will be exempted so that innovative products can be quickly released to the market.

 

The special exceptions for certification and permitting of manufacturing enterprises will be implemented within the first half of next year when the relevant regulations are revised.