In the U.S. healthcare market, market access refers to the degree to which health-related products, services, and solutions can be identified, researched, purchased, used, and evaluated by individuals, organizations, and communities.
Complete market access is evidenced by the unrestricted flow of information, money, manpower (e.g., clinicians), materials (e.g., products), and methods (e.g., services) under "free market" conditions (supportive of the "invisible hand" of capitalism).
Market access is supported by qualitative and quantitative evidence of value, with value determined or assured through health economics and outcomes research (HEOR), comparative-effectiveness research (CER), patient-reported outcomes (PROs), evidence-based medicine (EBM), real-world data (RWD), real-world evidence (RWE), and longitudinal real-world results (RWR). Health technology assessment (HTA) organizations like the Institute for Clinical and Economic Review (ICER) contribute to the evidence base. Product, service, and solution developers may compile global value dossiers (GVDs) to support market access. The intellectual, political, and economic interplay of academics, health and human services (HHS) professionals, connected professional communities (e.g., health economics professionals), and trade associations (e.g., the Pharmaceutical Research and Manufacturers of America [PhRMA]) may help set the standards for value assessments.
Market access may be restricted through a variety of means including the coverage (e.g., formulary), insurance coding, reimbursement, value-based contracting (VBC), and outcomes-based compensation (OBC) policies of third-party administrators (TPAs), third-party payers (TPP), capitated healthcare providers (e.g., Kaiser), and self-funded employers (e.g., Boeing).
Restrictions may be applied in the interest of reducing healthcare costs (e.g., under group health, workers' compensation, short-term disability, or long-term disability benefits); improving healthcare value (e.g., economic, clinical, and humanistic outcomes [ECHOs]); asserting political or economic authority; and other factors.
Market access affects the wellbeing, productive capacity, and socioeconomic status of individuals, organizations, and communities.
These individuals, organizations, and communities include but are not limited to U.S. consumers, patients, subpopulations (e.g., covered lives under fully-funded and self-funded health insurance plans), health plan sponsors or health plan purchasers (e.g., self-insured employers and unions), healthcare practitioners (e.g., HCPs including MDs/DOs, as well as allied healthcare and public health professionals), healthcare providers organizations (e.g., patient-centered medical homes [PCMHs], primary care super clinics [PCSCs], specialty medical practices, hospitals and health systems, accountable care organizations [ACOs]), and health plans (public and private insurers such as BCBS, Aetna, Medicare, Medicaid, TRICARE).
A broad range of individuals, organizations, and communities in the U.S. healthcare market now employ market access strategies to protect their financial, clinical, and humanistic interests. For example, parents, nutrition companies, and patient advocacy groups may engage lobbying firms to ensure legislators mandate insurance coverage for less obvious healthcare products such as medical foods for phenylketonuria (PKU).
These individuals, organizations, and communities may rely on specialized consulting firms to promote or restrict market access. Typical consulting services include (1) mapping disease progression and costs (e.g., economic, clinical, and humanistic); (2) identifying value-drivers and building those into new products, services, and solutions; (3) ensuring payment mechanisms are in place to facilitate commerce (e.g., diagnostic codes [e.g., International Classification of Diseases also known as ICD-9 and ICD-10], insurance billing codes [e.g., Current Procedural Terminology also known as CPT or HCPCS Level I codes, Healthcare Common Procedure Coding System Level II codes also known as HCPCS II codes], value-based contracts [VBCs], outcomes-based compensation [OBC] agreements; (4) ensuring measurement systems are in place to assess value (e.g., validated instruments that generate real-world data [RWD] and real-world evidence [RWE]); (5) building the case for coverage, coding, reimbursement, value-based contracts (VBC), outcomes-based compensation (OBC), real-world data (RWD) and real-world evidence (RWE) collaborations; (6) establishing inter-organizational learning systems to create feedback loops on value; and (7) advocating for expanded market access.
Many health industry stakeholders now apply advanced data science methods to (1) define and measure value and (2) expand or restrict market access based on value. The need to share real-world data (RWD) and generate real-world evidence (RWE) creates new demands on legislators and regulatory policymakers, as new types of collaboration become essential. The U.S. Food and Drug Administration (FDA) has issued new guidance for drugs and biologics as well as medical devices, along with a framework for real-world evidence programs. The U.S. government apparently sees value in accelerating development of real-world scientific evidence for medical products within the existing U.S. regulatory framework.
According to the World Trade Organization, "market access for goods in the WTO means the conditions, tariff and non-tariff measures, agreed by members for the entry of specific goods into their markets."
Market access is commonly used to describe the ability of a firm or a country to sell their goods and services across borders. Market access, however, does not mean the same as free trade because the ability to sell in a foreign market is often conditioned by tariff and non-tariff requirements, whereas free trade implies that goods and services may be circulated across borders without such barriers. Having said that, gaining market access is considered an essential step towards deepening trade ties. Market access is indeed a more achievable goal in trade negotiations as compared to free trade.
Market access for goods and services from other countries to the market of a WTO Member can be, and frequently is, impeded or restricted in various ways. These barriers or restrictions can be tariff or non-tariff barriers. The most common tariff barriers to market access are –at least for goods– customs duties. Non-tariff barriers to market access may –for goods as much as for services and service suppliers– take the form of: • quantitative restrictions; • other non-tariff barriers, such as technical barriers to trade, lack of transparency of national trade regulation, unfair and arbitrary application of national trade regulation and customs formalities and procedures. Different WTO rules are applicable to these tariff and non-tariff barriers to market access. This different treatment reflects a difference in the negative economic impact of these trade barriers.
A customs duty, or tariff, is a financial charge, in the form of a tax, imposed on products at the time of, and/or because of, their importation. Market access is conditional upon the payment of the customs duty. Most customs duties are ad valorem, i.e. a percentage of the value of the imported product. The customs duties or tariffs imposed by a country (or an autonomous customs territory) which are due on importation are set out in the country's (or an autonomous customs territory's) ‘tariff’. A tariff is a structured list of product descriptions and their corresponding custom duties.
Useful Databases on Market AccessEdit
- ITC's Market Access Map, interactive portal providing information on customs tariffs and market requirements.
- ITC's Non-Tariff Measures Business Survey database, including regulatory and procedural obstacles that trading companies face both at home and abroad.
- EU's Market Access Database (MADB) gives information to companies exporting from the EU about import conditions in third country markets: