Many of Applied Policy’s clients are global organizations with a keen interest in what challenges and opportunities exist for diagnostic lab tests around the world. Particularly as healthcare systems transition from unprecedented pandemic testing situations, we see countries reassessing not only lab budgets but testing priorities. This month, we share the results of our “check-up” on developments in lab test reimbursement in five key ex-U.S. countries.
🇫🇷 France
The NABM catalog, the main catalog for reimbursement of in vitro diagnostic (IVD) tests within France’s statutory health insurance, is updated several times a year on a regular basis. New codes, modifications of old ones, or tariff changes (e.g., change of B-coefficient) can be implemented following the decision of the National Union of Health Insurance Funds (UNCAM) at any time during the year.
In December 2022, Article 51 of the Social Security Financing Act for 2023 instituted both general and targeted price reductions for laboratory testing under cost-cutting reforms. (Tests connected to the management of the COVID-19 crisis were excluded.) Specifically, tariff reductions aimed to generate savings of at least €250 million in 2023 if no agreement between the government’s Health Insurance and medical biologists (i.e., laboratorians) was reached before February 1, 2023.
Addressing the French Senate, Gabriel Attal, Minister of Public Accounts, stated that the nation’s medical laboratories, which had been profitable before COVID, had realized a €7 billion in “testing revenue” over the past two years. In interviews with Le Monde and French television, François Braun, the nation’s Minister of Health and Prevention, described the sector as having “benefited greatly from the COVID crisis” and well-positioned to weather the proposed cuts.
The proposed savings were sharply criticized, and the diagnostics sector pushed back. Inovie Gen-Bio, which operates 35 laboratories, argued that lab testing represented only two percent of France’s total health expenditure and warned that imposing “discount” prices would negatively impact the efficiency of the health system.” Lionel Barrand, the president Les Biomed, the national union of medical biologists, cautioned that the proposed cuts would lead to “dark years for local medicine.”
Members of the Alliance de la Biologie Médicale (ABM) protested by refusing to forward COVID test results to the government’s database, forcing the French government to advise caution in the interpretation of COVID statistics. Nationwide strikes by labs delayed access to medical testing in all but emergent cases.
The second strike was cut short on January 10, 2023, when an agreement between UNCAM and associations of medical biologists was reached. Addendum 11 to the National Convention for Laboratory Directors aims to implement a compromise to the financial measures provided by the Social Security Financing Act. Specifically, according to the Addendum, as of February 2023, the base rate value, which is multiplied by the B-coefficient to obtain reimbursement tariffs in euros for the tests registered in the NABM, is reduced by one euro cent (for metropolitan departments – from 0.27 to 0.26).
On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The tariff reductions came into force on February 1, 2023, with total targeted reductions for 2023 estimated at €45 million. Additionally, from 2024-2026 parties will work collaboratively to define a framework for financing and regulating lab expenditures.
🇨🇭Switzerland
Reimbursable IVD tests in Switzerland are listed in Annex 3 (“List of Analyses”) of the health care benefit ordinance (KLV/OPre). The List of Analyses is typically updated twice a year. As part of a years-long campaign, santésuisse, the national association of Swiss health insurance companies, successfully argued that the prices charged for laboratory testing had outpaced their own premium increases under the country’s compulsory insurance program.
The association noted that prices for diagnostic testing, which had not been reviewed by the Federal Department of the Interior (DFI) since 2009, did not reflect economies of scale labs have realized through technological advances (e.g., automation). Santésuisse also released a study showing that thirty-nine of the most common laboratory tests in Switzerland cost on average three times as much as in Germany, France, Austria, or the Netherlands. It also found that Switzerland pays disproportionately more for laboratory materialsthan neighboring countries. As a result, since August 2022, tariffs for all IVD laboratory services – except point-of-care tests – have been reduced by 10 percent. The across-the-board reductions will result in annual savings of approximately CHF140 million. Further studies through 2025 will seek additional savings in the sector.
Additionally, since July 2022, results from a Health Technology Assessment (HTA) now limits payment and frequency for vitamin D testing only to those with an illness or suspected illness related to a vitamin D deficiency. The expected savings from this measure are CHF30 million. Applied Policy notes that this result clearly demonstrates that the HTA re-evaluation program is active and that its outcomes can have a significant impact, including on the reimbursement of the IVD tests
Finally, on December 9, 2022, the Swiss parliament mandated that the DFI would no longer set rates for IVD tests. The rates will now be negotiated by health insurance companies. The Federal Law on Health Insurance (KVG) will be amended accordingly.
🇩🇪 Germany
The EBM catalog (Einheitlicher Bewertungsmaßstab) regulates the reimbursement of services in the public outpatient sector in Germany (including IVD tests). It is updated once a quarter (four times a year). New codes, modifications of old ones, or tariff changes can be implemented following the decision of the Evaluation Committee (der Bewertungsausschuss) during the year (typically when the quarterly updated EBM catalog is published). We note that IVD tests in Germany have seen both payment increases and reductions as the federal government realigns budget and health priorities.
In July 2022, in connection with positive developments of the microbiology services in the EBM catalog(specifically concerning the direct (nucleic acid) detection of pathogens), the Evaluation Committee decided to introduce a series of reimbursement changes. Most significantly, changes include an over 20 percent reductionto the tariff for the quantitative determination of HIV RNA and the removal of some EBM codes for the detection of pathogens using less sensitive/specific methods (e.g., the EBM code 32703 for the antigen detection of Neisseria gonorrhoeae using immunofluorescence and/or immunoassay).
Positively, an approximately 20 percent increase of the tariffs for nucleic acid detection of multiple pathogens (M. tuberculosis, Cytomegalovirus, Toxoplasma, pathogens in the cerebrospinal fluid, HCV, Chlamydia, Mycoplasma, Polyomavirus in immunodeficient patients) has been realized. In addition, multiple EBM codes for the nucleic acid detection of various pathogens were introduced; for example, several EBM codes, which can be used for the detection of panels of acute respiratory infections (EBM code 32851), sexually transmitted infections (EBM code 32852), and acute gastrointestinal infections (EBM code 32853).
Overall, the changes led to an increase in the financing of microbiology services by €5.75 million.
🇬🇧 England
Applied Policy considers the website of NHS England, and the website of the British Association for Clinical Biochemistry and Laboratory Medicine (ACB) when researching IVD test information. Generally, no significant changes are expected in 2023-2024 in terms of payment mechanisms for IVD tests and budgets for laboratory testing in England.
The 2023/25 NHS Payment Scheme (NHSPS) is currently available in draft and will come into force from April 1, 2023. NHSPS will replace the National Tariff Payment System, covering secondary and specialized care and it will be set for two years. As in 2022/23, there will be no separate reimbursement tariffs for IVDs. The key payment mechanism remains “aligned payment and incentive” (API) approach – a combination of global budget (fixed component) and activity/quality-based payment (variable component).
The British government is committed to “Genome U.K.,” a multi-year program which the British Health and Social Care Secretary Steve Barclay said will make the country—already a leader in genomic healthcare and research—a “life sciences superpower.”
After being the first healthcare service in the world to offer whole genome sequencing as part of routine care, the U.K.’s National Health Service (NHS) is pursuing a new level of use. In December, the British Government announced over £175 million in funding towards achieving its stated goal of creating “the most advanced genomic healthcare system in the world.”
Most of the funding–£105M—will go towards studying “the effectiveness of using whole genome sequencing to find and treat rare genetic diseases in newborn babies.” Up to 100,000 newborns are expected to be voluntarily enrolled in genome sequencing in the next two years. Additionally, £26 million is earmarked for the development of a new cancer program which will investigate the use of genomic sequencing to make cancer diagnosis faster and more accurate. The program also includes funding for functional genomics, including the use of such tools as gene editing in understanding disease, improving diagnostics, and realizing new treatments.
Additionally, from 2023-2025, more IVD tests are expected to be provided through Community Diagnostic Centres (CDC). These Centers were launched by the Department of Health and Social Care in 2021 and are funded by the government. The vision of CDCs is to be “one-stop-shops for checks, scans, and tests” to speed up the diagnosis of conditions from cancer to heart or lung disease. As of December 2022, ninety two CDCs are opened in various settings, forty seven of which are built on existing hospital sites. Since October 2022, two million tests have been carried out in CDCs. Seven more CDCs will be opened in 2023/24, and the ambition is to roll out one hundred and sixty centers by 2025. Examples of IVD tests performed in CDCs are point-of-care tests, N-terminal pro b-type natriuretic peptide (NT-Pro BNP) test, urine testing, and D-dimer testing.
🇮🇹 Italy
The Italian IVD testing market is relatively static, and system changes do not occur as often as in some other European countries. Most significantly, in October 2022, the Ministry of Health introduced a decree which approved €5 million for both 2022 and 2023 for the financing of next-generation sequencing (NGS).
On the national level, the list of reimbursable outpatient services (including IVD tests) is provided in Annex 4 of the 2017 LEA document (i.e., the LEA catalog). It contains an exhaustive list of outpatient services (including IVD tests) guaranteed to the Italian population. After inclusion into LEA, the Ministry of Health introduces new codes into the outpatient reimbursement nomenclature and determines the national benchmark tariffs for these tests. There might be some time lag between inclusion into the LEA and the release of the new list of reimbursable outpatient codes by the Ministry of Health. The latest national benchmark tariffs were approved in 2012. It is expected that the new national tariffs (currently in the draft version from 2022) will be significantly lower compared to the 2012 national tariffs. The updates are expected to be effective in January 2024.