[MDREX NEWSLETTER] KRW 2.6 Trillion Annual Adjustment to Laboratory Test, CT and MRI Fees Confirmed for January 2027

[MDREX NEWSLETTER] KRW 2.6 Trillion Annual Adjustment to Lab

2026. 10. 30.

[MDREX NEWSLETTER] KRW 2.6 Trillion Annual Adjustment to Laboratory Test, CT and MRI Fees Confirmed for January 2027 — Implications for Healthcare Providers and Medical Device Companies and How to Prepare

KRW 2.6 Trillion Annual Adjustment to Laboratory Test, CT and MRI Fees Confirmed for January 2027 — Implications for Healthcare Providers and Medical Device Companies and How to Prepare

October 30, 2026

On October 28, 2026, the Ministry of Health and Welfare (MOHW) convened the 19th Health Insurance Policy Deliberation Committee (HIPDC) meeting and approved the implementation measures for the “Health Insurance Fee Structure Reform Plan” and the “Plan for Conditional Compensation for Referred Laboratory Testing.” Accordingly, fees for 702 laboratory test items, including blood tests, and 480 CT and MRI items will be reduced from January 1, 2027. The referral test management fee (10% of the test fee) will be abolished, and separate payment will begin, with the National Health Insurance Service (NHIS) paying the respective shares of test fees directly to referring and testing institutions. The government estimates savings of approximately KRW 2.6 trillion annually (KRW 1.9 trillion from laboratory tests and KRW 0.7 trillion from imaging), which will be directed toward fee increases for regional and essential healthcare (KRW 2.7 trillion).

This is the largest fee realignment since the current relative value-based fee system was introduced in 2001. Lower test fees will directly reduce the revenue of healthcare providers performing tests. The impact is likely to extend to medical device companies supplying in vitro diagnostic reagents and equipment, diagnostic imaging equipment and related services, through demands for lower unit prices and delayed investment.

This newsletter provides a detailed review of: ① MOHW’s changes to laboratory and imaging test fees; ② the impact on healthcare providers and companies and projected revenue changes; ③ responses to date from professional societies, industry and companies; ④ the National Assembly audit, HIPDC decisions and next steps; and ⑤ how companies should prepare.

1. MOHW’s Changes to Laboratory and Imaging Test Fees

1-1. Background and Developments

The government concluded that laboratory tests and CT/MRI scans are substantially overcompensated relative to their costs, creating a structure that favors testing over essential basic care, such as adequate consultations. According to the cost analysis cited by the government, based on 2023 accounting data from 168 institutions (including 6 tertiary general hospitals, 74 general hospitals and 88 clinics), the reimbursement-to-cost ratio was approximately 190% for laboratory tests and 194% for CT/MRI (i.e., fees were nearly double the cost), compared with approximately 71% for consultations and 57% for inpatient care (i.e., reimbursed below cost). The government intends to lower fees in overcompensated areas, redirect funds toward undercompensated areas – including primary care, emergency services, pediatrics and childbirth, and shorten the fee revision cycle from the current five-to-seven-year interval to within two years.

Timing	Key Developments
Dec. 2025	24th HIPDC meeting — Report on the “Plan to Reform Compensation for Referred Laboratory Testing and Strengthen Quality Management” (proposed abolition of the referral test management fee, separate payment to referring and testing institutions, and stronger quality management)
Mar. 2026	Written responses to the work report of the National Assembly Health and Welfare Committee — Proposed adjustment of overcompensation (approximately 190% of cost), introduction of separate payment, stricter accreditation standards for testing institutions and restrictions on re-referral
May–June 2026	Joint briefings with relevant professional societies (May 27–June 10), public hearing (June 17), HIPDC subcommittee discussion (June 18)
June 25, 2026	12th HIPDC meeting — Approval of the “Health Insurance Fee Structure Reform Plan”: KRW 3.6 trillion in annual investment in regional and essential healthcare; KRW 2.6 trillion annual adjustment of overcompensation for laboratory tests and CT/MRI; adjustment of tests reimbursed at more than 150% of cost
July–Sept. 2026	Additional advisory meetings with laboratory medicine and radiology societies and others (July 21, Sept. 16); submission of comments by relevant societies and industry
Oct. 2026	National Assembly audit (MOHW audit on Oct. 8) and written questions — Calls for disclosure of the cost analysis basis and protection of essential tests
Oct. 28, 2026	19th HIPDC meeting — Implementation measures approved; January 2027 implementation confirmed; certain essential tests excluded from adjustment in response to National Assembly audit concerns

1-2. Laboratory Test Fee Adjustments (KRW 1.9 Trillion Annually)

For laboratory tests, 745 items across 41 subcategories with revenue exceeding 150% of cost were considered for adjustment. The final decision reduces fees for 702 items across 38 subcategories. In addition, the referral test management fee, previously calculated separately at 10% of the referred test fee, will be abolished. According to the government announcement, fees for laboratory tests, including blood tests, will fall by an average of approximately 28%.

Category	Adjustment	Annual Savings
Test fee reductions	Fee reductions for 702 items across 38 overcompensated subcategories (adjusted to approximately 150% of cost)	Approx. KRW 1.62 trillion
Abolition of referral test management fee	Abolition of the separate payment to referring institutions equivalent to 10% of the fee for referred tests	Approx. KRW 0.24 trillion
Exclusions from adjustment (fine-tuning)	No reductions for three subcategories, including laboratory medicine specialist validation fees, blood tests for bone marrow abnormalities and HLA histocompatibility immunological tests	Cut scaled back by approx. KRW 36.8 billion
Same principle, same fee	The same fee applies to infectious disease tests based on the same principle	Cut scaled back by approx. KRW 8.1 billion
Total	Overall laboratory test adjustments	Approx. KRW 1.9 trillion

In the example presented by the government in June, the fee for a complete blood count (CBC, instrument-based measurement) at a clinic falls by approximately 20%, from KRW 1,220 to KRW 970. These reductions are implemented by lowering the relative value scores for individual procedures themselves, rather than the price per point (conversion factor). It is therefore important to note that once the points are reduced, they will not return to their original level even if the conversion factor subsequently increases.

1-3. Imaging Test (CT/MRI) Fee Adjustments (KRW 0.7 Trillion Annually)

Category	Adjustment	Annual Amount
Scope of adjustment	All 480 items in two subcategories reimbursed at more than 150% of cost (96 CT and 384 MRI items)	Approx. KRW 0.73 trillion
Interpretation fees and emergency add-ons retained	Radiologist interpretation fees and emergency add-ons maintained at current levels	Cut scaled back by approx. KRW 56.6 billion
Musculoskeletal MRI	Separate identification of musculoskeletal MRI interpretation fees	Approx. KRW 3 billion
Total	Average CT/MRI fee reduction of approximately 25%	Approx. KRW 0.7 trillion

In other words, imaging acquisition (examination) fees will fall, while specialist interpretation fees will be maintained. Healthcare providers operating the equipment will see lower acquisition revenue, while the relative value of interpretation expertise will be preserved.

1-4. Separate Payment and Conditional Compensation for Referred Laboratory Tests (Two-Year Temporary Scheme)

Previously, referring institutions (mainly clinics) received the full test fee from the NHIS and then settled payment privately with the testing institutions (specialized laboratories) that performed the tests. This process gave rise to competition through test fee discounts and concerns about lower test quality and patient safety issues such as specimen mix-ups. From January 2027, the NHIS will pay referring and testing institutions directly for their respective roles, and institutions meeting requirements for improved test quality will receive differentiated conditional compensation for two years.

Category	Referring Institutions (Hospitals and Clinics Ordering Tests)	Testing Institutions (Institutions Performing Tests)
Payment method	NHIS directly pays the referring institution’s share	NHIS directly pays the testing institution’s share (preventing inter-institution settlement and discounts)
Conditional compensation requirements	Establish a system for prompt, accurate sharing of test results with testing institutions, and provide test result analysis and management for patients with chronic diseases and others	Perform complex, low-volume tests and tests referred from medically underserved areas; manage quality throughout the testing process, including specimen management and result reporting
Compensation	Clinical result analysis and management fee of KRW 1,400 per session (four times per patient annually); institution-level compensation based on performance, including the appropriateness of test ordering volume	Add-ons for complex, low-volume tests and underserved areas (planned for March 2027); institution-level compensation based on quality management and process improvement performance
Allocation Structure (June 25 Announcement)	Laboratory diagnostics: 25% base + 10% conditional Pathology: 10% base + 5% conditional	Laboratory diagnostics: 45% base + 20% conditional Pathology: 80% base + 5% conditional

Note: These allocation ratios were announced in June. The detailed ratios and conditional compensation indicators will be finalized in the November amendments to the relevant notices.

1-5. Phased Roadmap

✔	Phase 1 (Effective January 2027): Adjust reimbursement from approximately 190% to 150% of cost; abolish the referral test management fee; introduce separate payment and conditional compensation
✔	Cost Reanalysis (2027): Analyze costs separately for referring and testing institutions; monitor implementation impact quarterly; conduct an impact study by the Health Insurance Review and Assessment Service (HIRA)
✔	Phase 2 (Planned for the Second Half of 2028): Further adjustment to approximately 110% of cost under the June roadmap — to be reassessed based on cost analysis findings

1-6. Concurrent Increases in Compensation (Offsetting Factors for Healthcare Providers)

At the same time, KRW 2.7 trillion will be allocated to fee increases for regional and essential healthcare. Clinic consultation fees will rise by 6% for initial visits and 4% for follow-up visits (2% at hospitals and above). Including the 2027 conversion factor adjustment, the initial consultation fee at clinics will increase from KRW 18,840 to KRW 21,210. Base inpatient fees will rise by 7% for general wards and 10% for intensive care units, while fees for 1,670 surgeries and procedures for severe conditions at general hospitals and above will increase by 20%. Overall, providers that depend heavily on testing will see revenue fall; those focused on consultations and surgery will benefit.

2. Impact on Healthcare Providers and Medical Device Companies

Lower test fees initially reduce the revenue of healthcare providers performing tests, who then seek to offset the loss by cutting costs. Because reagent and consumable purchase prices and equipment acquisition and maintenance costs are among the most readily adjustable testing costs, the impact is quickly passed on to suppliers. The figures below are MDREX estimates based on government examples and publicly available information; actual impacts vary with each institution’s test mix and contractual terms.

2-1. Impact by Provider Type

Provider Type	Key Impact	Expected Change (Phase 1)
Clinics (primarily referring tests)	Abolition of the referral test management fee and separate payment fix the referring share, substantially reducing the test-related income previously earned through settlement arrangements. Consultation fee increases and clinical result analysis and management fees will partially offset this.	Revenue per referred test down approximately 44% (CBC example) Note: CBC = Complete Blood Count
Referral testing laboratories	Test fee reductions apply directly, but the end of discount-based settlements means laboratories receive the standard testing share. Profitability depends on whether they qualify for conditional compensation.	Per-test revenue down approximately 14% (conditions met) to approximately 40% (conditions not met)
General and tertiary general hospitals (in-house testing)	Test fee reductions directly translate into lower revenue, but increases for surgery for severe conditions (20%) and inpatient care offer substantial potential offsets.	Affected laboratory tests down approximately 28% on average; CT/MRI down approximately 25%
Radiology clinics and health screening centers	Directly affected by lower acquisition fees. Interpretation fees are maintained, but capacity to invest in equipment declines.	CT/MRI acquisition revenue down approximately 25%
Pathology tests (histology/cytology)	Items reimbursed below 150% of cost are not subject to test fee reductions; only abolition of the referral test management fee and separate payment apply.	Lower referring share; potential improvement in actual receipts for referral pathology laboratories

2-2. Example: One CBC Referred by a Clinic

Item (KRW)	Current	Post-Reform	Change
Test fee	1,220	970	−20%
Referral test management fee	122	Abolished	−100%
Total amount claimed	1,342	970	−28%
Amount received by referring institution (clinic)	Approx. 610	Up to 340	−44%
Amount received by testing institution	Approx. 732	Up to 631	−14%

Note: Current actual receipts are MDREX estimates assuming a customary discount of approximately 40% between referring and testing institutions. Post-reform amounts assume receipt of both the base share and conditional compensation. If a testing institution does not qualify for conditional compensation, its payment falls to the base share (45%), or approximately KRW 437.

2-3. Examples of Annual Provider Revenue Changes

(Example 1) Internal medicine clinic — primarily referred testing. For a clinic currently earning KRW 7.5 million per month (KRW 90 million annually) from referred testing, applying the same decline as in the CBC example (−44%) would reduce revenue to approximately KRW 4.2 million per month (approximately KRW 50 million annually), an estimated loss of approximately KRW 40 million annually. Even if the clinic receives the full clinical result analysis and management fee for 500 patients with chronic diseases (KRW 1,400 × four times annually), this amounts to only approximately KRW 2.8 million annually. Clinics heavily reliant on testing will therefore face a net revenue decline even after consultation fee increases.

(Example 2) General hospital — primarily in-house testing. For a general hospital earning KRW 5 billion annually from laboratory tests and KRW 3 billion from CT/MRI, a 25% average reduction affecting 80% of laboratory tests would reduce revenue by approximately KRW 1 billion. An effective 20% reduction in CT/MRI acquisition fees, allowing for maintained interpretation fees, would reduce revenue by approximately KRW 600 million. Testing alone would thus lose approximately KRW 1.6 billion annually (approximately 20% of testing revenue). However, higher fees for surgery for severe conditions and inpatient care could offset a substantial share of this loss, so hospitals are likely to intensify pressure to cut testing costs first.

Note: These examples are simple calculations applying assumptions to published average reduction rates. Actual impacts vary considerably with each institution’s test mix.

2-4. How the Impact Reaches Medical Device Companies

Channel	Description	Companies Primarily Affected
① Price (unit price)	Laboratories demand lower reagent and consumable supply prices and equipment rental fees to preserve margins. Pressure is stronger for routine tests.	Laboratory diagnostic reagents and equipment (hematology, biochemistry, immunology, urinalysis, etc.)
② Volume	A smaller referring share may reduce clinics’ incentive to refer tests. Conversely, professional societies warn of a “balloon effect” – a compensatory surge in test volumes to offset revenue losses – as occurred after previous fee cuts.	Reagents and equipment heavily dependent on referred testing
③ Channel concentration	Conditional compensation and stricter accreditation standards concentrate volumes in large referral laboratories, increasing their bargaining power in tenders and bulk purchasing.	Companies heavily reliant on sales to referral laboratories
④ Investment and replacement cycles	Lower CT/MRI acquisition fees delay new equipment purchases and replacement, increasing demand for low-cost or refurbished equipment and renegotiation of maintenance contracts. Meanwhile, plans to introduce equipment age indicators for CT, MRI and mammography systems and differentiate health insurance fees may increase the need for replacement and upgrades, adding to providers’ investment burden. Note: Equipment age assessment: 10 points for equipment under five years old; 0 points for equipment 15 years or older; 2 additional points for maintenance or upgrades.	CT/MRI equipment, contrast media and injectors, maintenance services
⑤ Opportunities	Conditional compensation indicators – specimen tracking, rapid reporting, quality management, and complex testing – and the retention of interpretation fees at the current levels both increase the value of products that support these functions.	Laboratory automation and information systems, complex molecular and specialized tests, pathology and digital pathology, interpretation support software

2-5. Projected Company Revenue Changes (Simulation)

Assuming a company with KRW 10 billion in domestic laboratory diagnostic reagent sales and variable costs of 40% (a gross margin of 60%), we estimated changes in revenue and gross profit resulting from customer laboratories’ demands for lower unit prices and changes in volume.

Scenario	Assumptions	Revenue	Gross Profit
Current	—	KRW 10 billion	KRW 6 billion
Conservative	Unit price −5%, volume +3% (partial balloon effect)	KRW 9.79 billion (−2%)	KRW 5.67 billion (−6%)
Base	Unit price −10%, no volume change	KRW 9.00 billion (−10%)	KRW 5.00 billion (−17%)
Adverse	Unit price −20%, volume −5% (fewer referrals)	KRW 7.60 billion (−24%)	KRW 3.80 billion (−37%)

Without offsetting cost reductions, price cuts flow directly to the bottom line, meaning gross profit declines much more sharply than revenue. If laboratories seek to preserve their margins, the unit price reductions demanded in laboratory diagnostics could approach the test fee reduction rate (approximately 20–28%), potentially cutting gross profit by nearly half. Pressure will increase further if Phase 2 proceeds as planned in 2028.

3. Responses to Date from Professional Societies, Industry and Companies

3-1. Professional Societies and the Medical Community

✔	Korean Society for Laboratory Medicine (statement of February 19, 2026): The society criticized the cost analysis sample as insufficiently representative, noting the exclusion of the so-called “Big Five” hospitals (Korea’s five largest academic medical centers), and stated that the 2023 referred-testing data reflected excessive discount competition. It also argued that cost recovery ratios exceeding 100% again after previous fee cuts (in 2017 and 2024) reflected a “balloon effect” – increased testing to offset losses – rather than overcompensation, and called for an end to unilateral reductions.
✔	Korean Hospital Doctors Association (statement of June 18, 2026): The association highlighted the risks of uniform cuts based on averages and called for disclosure of the cost analysis methodology, adjustment factors for regional and small institutions, and transitional safeguards.
✔	Korean Society for Laboratory Medicine and Korean Society for Transplantation: The societies requested exclusions or separate adjustments for tests requiring specialist interpretation or expensive reagents and tests related to organ and hematopoietic stem cell transplantation.
✔	Korean Society for Laboratory Medicine and other medical groups (Yonhap News, October 28, 2026): They pointed out that the 2023 cost survey included institution-type add-ons (30% for tertiary general hospitals and 25% for general hospitals), which were abolished from 2024, resulting in an approximately 30% overestimation of the cost recovery ratio.
✔	Concerns from the medical community and IVD industry (Yonhap News, October 28, 2026): They warned that uniform fee reductions of 25% or more based on inaccurate underlying statistics could cause cascading harm to domestic precision diagnostic kit and reagent developers and the broader IVD industrial base.

3-2. Industry (Korea Medical Devices Industry Association IVD Committee)

In a September 2026 contribution, the IVD Committee’s reimbursement subcommittee stated its official position: while supporting the intent of the government’s reform, it opposes treating all laboratory testing as a single “overcompensated area.” Its key proposals are summarized below.

Proposal	Key Points
Detailed cost analysis	Reflect actual costs, including not only equipment and reagents but also installation, maintenance, calibration, quality control, specialized staff, specimen transport, laboratory information systems and waste disposal; disclose calculation criteria
Differentiated compensation	Reflect complexity, risk and clinical value, including difficulty of result interpretation, patient risk from errors and the value of rapid results
Separate pathway for innovative technologies	A flexible system progressing from temporary or conditional compensation to accumulation of real-world evidence and reassessment
Stakeholder participation and fair competition	Meaningful participation by the medical community, laboratories, companies and patients. The association does not collectively set prices or discount limits.

The association also reflected on the industry’s own practice of passively accepting discount demands and repeatedly cutting prices, emphasizing competition based on the combined value of accuracy, clinical utility, supply reliability and after-sales support, rather than price. The association plans to hold its regular IVD Committee workshop on November 3 to discuss responses to the fee reform and future priorities.

4. National Assembly Audit, HIPDC Decisions and Next Steps

4-1. Issues Raised in the National Assembly Audit

The National Assembly Health and Welfare Committee’s audit began on October 7, followed by the MOHW audit on October 8 and the comprehensive audit on October 27. The following issues were raised regarding laboratory test fee reform.

✔	Calls for disclosure of the cost analysis basis: Representative Lee, Man-hee (People Power Party) requested the calculation methodology and detailed analysis underlying the “190% of cost” figure central to the fee cuts, but MOHW did not provide them. MOHW had also declined the laboratory medicine society’s earlier request to disclose the methodology, citing the need for final validation.
✔	Adequacy of the costs included: Asked whether the analysis accounted for differences between manual and automated tests, test volume, specialized staff and quality control costs, equipment depreciation and maintenance, disposal of low-volume reagents, and night/holiday standby costs, MOHW stated that all cost categories in the accounting data had been included. However, it acknowledged that manual and automated tests sharing the same fee code are difficult to distinguish.
✔	Protection of essential testing infrastructure: In written responses, MOHW agreed that fee reform should not weaken patient safety or essential testing infrastructure. It said it would consider exceptions for tests involving specialized staff, expensive reagents or low volumes, such as HLA antibody testing, bone marrow interpretation and microbial culture, as well as complexity and low-volume add-ons for transplant and infectious disease tests. It also stated that HIRA would conduct a policy impact study in 2027.

4-2. Results of the 19th HIPDC Meeting (October 28)

Some concerns raised in the National Assembly audit were reflected in the HIPDC decision of October 28.

Issues Raised by the Audit and Societies	HIPDC Decision	Annual Effect
Protect specialist interpretation and tests using expensive reagents	Exclude laboratory medicine specialist validation fees, blood tests for bone marrow abnormalities and HLA histocompatibility immunological tests from reductions	Cut scaled back by KRW 36.8 billion
Equity among infectious disease tests	Apply the same fee to infectious disease tests based on the same principle	Cut scaled back by KRW 8.1 billion
Value of radiologist interpretation	Maintain radiologist interpretation fees and emergency add-ons at current levels	Cut scaled back by KRW 56.6 billion
Musculoskeletal MRI	Separate interpretation fees	KRW 3 billion
Concerns about post-implementation impact	Establish quarterly monitoring and continue identifying further improvements	—

However, fundamental requests—disclosure of the cost calculation methodology, adjustment factors by institution type and region, and transitional safeguards—were not reflected in this decision. Implementation, originally envisaged for the “second half of 2026 (December),” was confirmed for January 2027.

4-3. Expected Next Steps

Timing	Procedure	What Companies Should Monitor
Nov. 2026	Administrative notice of proposed amendments to the notification— including the “Standards of Covered and Non-Covered Medical Services and Relative Value Scores for Health Insurance,” “Details on Application Standards and Methods for Medical Care Benefits,” and standards for referred laboratory testing, etc.	Review changes to relative value scores by procedure code and submit comments (the administrative notice period is generally over 20 days but may be shortened)
Nov.–Dec. 2026	Issue official notices after reviewing comments; update claims and review IT systems; notify healthcare providers	Inform customers of claims changes and prepare for 2027 contract price negotiations
Jan. 1, 2027	Implementation — laboratory test and CT/MRI fee adjustments, abolition of the referral test management fee, separate payment and conditional compensation (two years)	Track changes in customers’ test volumes and ordering patterns
Mar. 2027	Apply add-ons for medically underserved areas (alongside preferential regional fees)	Review sales strategies for customers in underserved areas
2027 (quarterly)	Monitor implementation impact; HIRA impact study; reanalyze costs separately for referring and testing institutions	Accumulate actual cost and clinical value data and prepare evidence submissions
Second half of 2028	Phase 2 adjustment (target of 110% of cost under the June roadmap, to be reassessed after cost analysis)	Prepare for potentially larger additional reductions than in Phase 1
Dec. 2028	Two-year conditional compensation period ends → redesign following performance evaluation	Document how products contribute to conditional compensation indicators

Note: The government announced the November 2026 administrative notice and January 2027 implementation schedules. Other dates are MDREX projections based on the June roadmap and typical notification amendment procedures.

5. How Companies Should Respond

This adjustment is not a one-off cut; it marks the start of a system that continually reviews and adjusts fees on a two-year cycle. From here, a company’s outcomes will depend less on the size of the cut and more to depend on what evidence is presented, when and through which procedure. Companies can begin preparing now.

① Map the Exact Scope of Impact by Procedure Code

Companies should map each procedure code to the relevant product to determine whether tests using their products are among the 702 adjusted items, belong to excluded subcategories, and how much their relative value scores will fall. A single product may span multiple procedure codes, and classification as laboratory diagnostics or pathology may result in opposite impacts. This work takes time and should preferably be completed before the administrative notice.

② Prepare Comments for the Administrative Notice

Administrative notice periods are short, and comments are more likely to be reflected when supported by specific items and objective evidence. As illustrated by the exclusion of HLA tests and others at this HIPDC meeting, data demonstrating cost structures and clinical needs can change outcomes. Aligning with professional societies and industry associations while separately preparing product-specific evidence is an effective approach.

③ Build Cost Evidence for Phase 2 (2028)

The 2027 cost reanalysis will form the basis for the 2028 Phase 2 adjustment. Companies should work with customer laboratories to document costs easily overlooked in cost analysis, such as equipment depreciation, maintenance, quality control, specialized staff and disposal of low-volume reagents, so they can be used as evidence in the next phase.

④ Link Conditional Compensation to Product Value

Conditional compensation assesses specimen tracking and management, rapid result reporting, quality management and complex testing. Demonstrating how a product helps customers qualify for this compensation provides the most persuasive basis for resisting demands for lower unit prices. In imaging, maintained interpretation fees increase the value of solutions that improve interpretation efficiency and quality.

⑤ Review Pricing and Contract Structures and Manage Legal Risks

Changing contract terms in response to demands for lower unit prices may raise legal issues involving fair competition rules, restrictions on economic benefits (rebates) and conflicts with existing contracts. Companies should avoid sharing price information with competitors or collectively deciding their responses. Legal review should accompany new arrangements, such as volume- or performance-linked contracts. Where necessary, companies may also consider objections to the notices or administrative litigation.

⑥ Consider Separate Compensation Pathways for Innovative Technologies

For new technologies disadvantaged by direct comparison with existing procedures, companies may also consider separate evaluation and compensation pathways, including new health technology assessment and innovative health technology schemes, to secure recognition of value independently of the existing fee system.

These preparations require an understanding of the relative value-based fee system, HIPDC and HIRA decision-making procedures, and relevant legislation, making it difficult for individual companies to address everything within a short period. MDREX has analyzed this reform from the outset with experts who have practical experience in HIRA reimbursement listing, and is examining both regulatory and legal aspects through collaboration with the law firm D&A LLC (formerly known as DR & AJU). We will continue sharing perspectives and information relevant to medical device companies as the notices are amended and Phase 2 discussions progress.

Sources: MOHW press releases (June 25 and October 28, 2026); HIPDC meeting materials (December 2025); Uihak Shinmun (October 19 and 28, 2026); Daily Medi (February 19 and March 23, 2026); Jaekyung Ilbo (October 10, 2026); Newspim (June 19, 2026); Rapportian (October 27 and 28, 2026); Bogeon Shinmun (September 9, 2026); and others. Figures on provider and company impacts are MDREX estimates applying assumptions to publicly available data. Final figures may vary depending on the amended notices.

If you would like to understand how laboratory and imaging fee reform may affect your products and customers, or what comments you could submit during the administrative notice period, please contact MDREX (pro@mdrex.co.kr) MDREX will work with you to help medical devices continue to receive appropriate recognition of their value and remain in clinical use after regulatory approval.