Market access and reimbursement determine whether an authorised product actually reaches patients and how it is paid for. Health Technology Assessment bodies evaluate clinical and economic value, and the EU HTA Regulation now provides joint clinical assessments for certain medicines and high-risk devices. Pricing negotiations, coverage decisions, and national reimbursement schemes vary widely across countries. This page collects the updates HealthSignal tracks on HTA, pricing and reimbursement policy, and coverage frameworks across Europe and the US, from official public sources.
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesCommission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideINFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalCompilation of Joint Clinical Assessment reports, procedural guidance on AI use in HTA dossiers, data transparency principles, and methodological FAQs for medical devices and IVDs.
EU HTA Regulation Implementation · EU-wideProposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · United StatesDiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyNICE adapts its evidence standards framework for digital health technologies to support decision-making for digital care technologies in adult social care.
UK NICE · UKIDAP pilot accelerates development and market integration of innovative medical devices addressing unmet NHS clinical needs.
UK MHRA · UKDiGA reimbursement shifts to outcome-based pricing with up to 20% contingent on demonstrated healthcare effects; insurer activation codes reduced to 2-day requirement.
BfArM DiGA Fast Track · GermanyRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesUpdated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideCMS proposes updates to physician fee schedule, Part B payment policies, Medicare Shared Savings Program, Quality Payment Program, and Promoting Interoperability Program for calendar year 2027.
US Federal Register - CMS Rules · United StatesJoint Clinical Assessments under the HTA Regulation now extend to selected high-risk medical devices and in-vitro diagnostics.
European Commission · EU-wideList establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes covered by public health insurance.
Czechia SUKL · Czech RepublicUpdated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 July 2026.
Czechia SUKL · Czech RepublicPortugal's INFARMED adds new homogeneous groups to the reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalCMS issued draft guidance on processes and requirements for manufacturers to implement maximum fair prices in the 2028 Medicare drug price negotiation program.
US CMS Newsroom · United StatesGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideILAP is a pathway to accelerate regulatory approval and NHS access for transformative new medicines.
UK MHRA · UKSUKL publishes a corrected list of prices and reimbursements for medicinal products under the public health insurance law.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official list of prices and reimbursement rates for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official price and reimbursement list for foods for special medical purposes under public health insurance.
Czechia SUKL · Czech RepublicCMS proposes updates to Medicare home health payment rates, case-mix weights, quality reporting requirements, and DME enrollment and benefit policies for calendar year 2027.
US Federal Register - CMS Rules · United StatesGreece's EOF pricing department proposes medicinal product prices for Q1 2026, open for public consultation.
Greece EOF · GreeceNICE invites input on adopting a new EQ-5D-5L value set to improve health-related quality-of-life assessments in treatment evaluation.
UK NICE · UKGuidance clarifying joint clinical assessment procedures under the EU HTA Regulation.
EU HTA Regulation Implementation · EU-wideGreece EOF pricing department proposes generic medicine prices for public consultation.
Greece EOF · GreeceFinal rule sets 2027 payment parameters, user fee rates for health plan issuers, risk adjustment provisions, and QHP certification standards including provider access and essential health benefit requirements.
US Federal Register - CMS Rules · United StatesFactsheets on joint clinical assessment and scientific consultation procedures under the EU HTA Regulation, plus implementation guidance and analysis of regional cooperation structures.
EU HTA Regulation Implementation · EU-wideList establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes from public health insurance.
Czechia SUKL · Czech RepublicProposed rule to codify the Medicare Drug Price Negotiation Program and establish new policies for drug pricing and the prescription drug benefit under the Inflation Reduction Act.
US Federal Register - CMS Rules · United StatesNICE recommends offering pregnancy-specific artificial pancreas devices to women with type 1 diabetes who are pregnant or planning pregnancy.
UK NICE · UKNICE recommends an online therapy programme for people aged 16 and over with eating disorders awaiting specialist NHS treatment.
UK NICE · UKNICE conditionally recommends five AI technologies as decision-support tools during bowel examinations to improve early detection of precancerous growths.
UK NICE · UKFinal rule revises Medicare Advantage, Prescription Drug Benefit, and cost plan regulations for Star Ratings, marketing, drug coverage, and enrollment.
US Federal Register - CMS Rules · United StatesMHRA, ASA and GPhC warn businesses against unlawful promotion of newly authorised and unlicensed weight-management medicines.
UK MHRA · UKGreece EOF publishes proposed retail prices for MHSYFA products for public consultation.
Greece EOF · GreeceConsultation on amendments to the headline payment percentage and consultation procedure of the branded medicines pricing control scheme.
UK DHSC · UKGreek EOF invites consultation on proposed pricing for new pharmaceutical cannabis final products.
Greece EOF · GreeceMHRA-NICE aligned pathway streamlines decision-making to accelerate patient access to new medicines by 3–6 months.
UK MHRA · UKMedicinrådet and Amgros now allow pharmaceutical companies to submit alternative pricing agreement proposals later in the assessment process than previously.
Medicinrådet (Danish Medicines Council) · DenmarkAdditional information on how to access the MHRA and NICE Integrated Scientific Advice service for medicines applicants.
UK MHRA · UKJoint Clinical Assessments become mandatory for new cancer medicines and advanced therapy medicinal products under HTA Regulation.
European Commission · EU-wideAEMPS establishes governance structure and implementation roadmap for coordinated application of the new European HTA framework.
AEMPS (Spanish Medicine Agency) · SpainAEMPS will serve as Medicine Evaluation Office and participate in governance of new Health Technology Assessment System aligned with EU Regulation 2021/2282.
AEMPS (Spanish Medicine Agency) · SpainGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier Procedural Guidance for Joint Scientific Consultations (JSC) on Medical Devices (MD) and In Vitro Diagnostic Medical Devic...
EU HTA Regulation Implementation · EU-wideEAMS provides early access to medicines for life-threatening or seriously debilitating conditions showing major therapeutic advantage.
UK MHRA · UKProposed rule on 2027 ACA payment parameters, user fees for qualified health plans, risk adjustment programs, and QHP certification standards.
US Federal Register - CMS Rules · United StatesThe HTA Member State Coordination Group has adopted guiding principles on data transparency.
EC Public Health · EU-wideMedicines Council approved new medicines, updated type 2 diabetes treatment guidance, and published the first national formulary list for June 2026.
Medicinrådet (Danish Medicines Council) · Denmark