Defining Eligible Entities

Each entity is responsible for determining its eligibility to report to and/or query the NPDB and must certify that eligibility to the NPDB when registering with the NPDB. Although the sections below describe eligible entities, entities are responsible for verifying their legal obligation or eligibility under applicable laws and regulations. The terms defined below are not mutually exclusive, and entities may qualify as more than one type of eligible entity. Entities should carefully review all terms and definitions prior to registering. When registering with the NPDB, entities certify their eligibility to participate based on the most appropriate eligible entity category. However, if an entity meets the definition of multiple entity categories, the entity must comply with all applicable querying, reporting, and other requirements. For example, if an entity is registered as a hospital under all three statutes but is also a self-insured medical malpractice payer, the entity is responsible for reporting any medical malpractice payments made for the benefit of a practitioner in addition to its querying and reporting responsibilities as a hospital.

Boards of Medical Examiners

A board of medical examiners (also referred to as a state medical or dental board) is a state licensing board that licenses, monitors, and disciplines physicians or dentists. This term includes a board of osteopathic examiners or its subdivision, a board of dentistry or its subdivision, or an equivalent body as determined by the state. See also state licensing boards.

Drug Enforcement Administration

The DEA is the U.S. agency tasked, in part, with enforcing the controlled substances laws and regulations of the United States, including provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances.

Federal Agencies

Federal agencies that are authorized to query the NPDB under Section 1921 and Section 1128E include:

• Agencies administering federal health care programs (including private entities administering such programs under contract and private entities providing payment for services)
• Federal agencies responsible for the licensing and certification of health care practitioners, providers, or suppliers (also referred to as federal licensing and certification agencies)
• Law enforcement officials and agencies, such as:
  • Attorney general
  • Chief postal inspector
  • Inspectors general
  • U.S. attorneys
  • Comptroller general
  • DEA
  • Nuclear Regulatory Commission
  • Federal Bureau of Investigation

Federal agencies that must report to the NPDB under Section 1128E include, but are not limited to:

• HHS
• Department of Justice
• Federal law enforcement agencies, including law enforcement investigators
• Any other federal agency that either administers or provides payment for the delivery of health care services, including, but not limited to, the DOD and the DVA
• Federal agencies responsible for the licensing and certification of health care practitioners, providers, or suppliers (also referred to as federal licensing and certification agencies)

Health Care Entities

The definition of a health care entity includes both hospitals and other health care entities.

Examples of hospitals and other health care entities are listed in Table B-2.

Hospitals

A hospital is defined under Section 1861(e)(1) and (7) of the Social Security Act.

Other Health Care Entities

A health care entity must provide health care services and follow a formal peer review process to further quality health care. The phrase "provides health care services" means the delivery of health care services through any of a broad array of coverage arrangements or other relationships with practitioners, either by employing them directly or through contractual or other arrangements. This definition specifically excludes indemnity insurers that have no contractual or other arrangement with physicians, dentists, or other health care practitioners.

A formal peer review process is the conduct of professional review activities through formally adopted written procedures that provide for adequate notice and an opportunity for a hearing.

Examples of other health care entities may include health maintenance organizations (HMOs), preferred provider organizations (PPOs), group practices, nursing facilities, rehabilitation centers, hospices, renal dialysis centers, free-standing ambulatory care and surgical service centers, patient-centered medical homes (PCMHs), accountable care organizations (ACOs), and other health care delivery models that meet the definition.

Examples of hospitals and other health care entities are listed in Table B-2.

Health Plans

The term health plan refers to a plan, program, or organization that provides health benefits, whether directly, through insurance, through reimbursement, or otherwise. Health plans include, but are not limited to:

• A policy of health insurance
• A contract of a service benefit organization
• A membership agreement with an HMO or other prepaid health plan
• A plan, program, agreement, or other mechanism established, maintained, or made available by a self-insured employer or group of self-insured employers; a health care practitioner, provider, or supplier group; a third-party administrator; an integrated health care delivery system; an employee welfare association; or a public service group or organization or professional association
• An insurance company, insurance service, or insurance organization that is licensed to engage in the business of selling health care insurance in a state and is subject to state law that regulates health insurance
• An organization that provides benefit plans with coverage limited to outpatient prescription drugs

Medical Malpractice Payers

A medical malpractice payer is an entity that makes a medical malpractice payment, through an insurance policy or otherwise, for the benefit of a health care practitioner in settlement of, or in satisfaction in whole or in part of, a claim or judgment against the practitioner.

Peer Review Organizations

A peer review organization is an organization with the primary purpose of evaluating the quality of patient care practices or services ordered or performed by health care practitioners against objective criteria that define acceptable and adequate practice, using a sufficient number of health care practitioners specializing in the area of review to ensure adequate peer review. The peer review organization also has due process mechanisms available to health care practitioners.

This definition specifically excludes utilization and quality control peer review organizations described in Part B of Title XI of the Social Security Act (referred to as quality improvement organizations [QIOs]) and other organizations funded by the Centers for Medicare & Medicaid Services (CMS) to support the QIO program.

Private Accreditation Organizations

A private accreditation organization evaluates and seeks to improve the quality of health care provided by a health care entity, provider, or supplier by measuring performance based on a set of standards and assigning a level of accreditation, as well as conducting ongoing assessments and periodic performance reviews of the quality of health care provided. A private accreditation organization must have due process mechanisms available to the health care entities, providers, or suppliers that it evaluates and accredits.

Professional Societies

A professional society is a membership association of health care practitioners at the national, state, or local level that follows a formal peer review process for the purpose of furthering quality health care.

Examples of professional membership societies may include national, state, county, and district medical and dental societies and academies of medicine and dentistry. Examples of professional organizations that ordinarily do not meet the definition of a professional society include medical and surgical specialty certification boards, independent practice associations, managed care organizations, and PPOs, although these organizations may meet one or more other eligible entity definitions.

Professional societies are not automatically eligible to query and/or report to the NPDB. A professional society must qualify as a "health care entity" as defined in Section 60.3 of the NPDB regulations. To meet NPDB eligibility requirements, a professional society must follow a formal peer review process for the purpose of furthering quality health care.

Quality Improvement Organizations

QIOs are private companies that hold contracts with CMS to monitor the quality of care provided to Medicare beneficiaries. One company for each U.S. state and territory is designated as the QIO for that region.

A QIO is a utilization and quality control peer review organization (as defined in Part B of Title XI of the Social Security Act) that is composed of, or has available to it in the area, by arrangement or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy engaged in the practice of medicine or surgery to assure adequate peer review of the services provided by various medical specialties and subspecialties, and is able to perform reviews of the pattern of quality of care in an area of medical practice where actual performance is measured against objective criteria for acceptable and adequate practice. The QIO must have at least one consumer representative on its governing body.

State Agencies Administering or Supervising the Administration of State Health Care Programs

State agencies administering or supervising the administration of a state health care program include state agencies that administer or supervise the administration of a state health care program, as well as those that provide payment for services, as defined in Section 1128(h) of the Social Security Act. These entities also are included in the definition of a state law or fraud enforcement agency because they have a role in investigating and preventing health care fraud and abuse and take certain final adverse actions consistent with that role.

State Law Enforcement Agencies

A state law enforcement agency is included in the definition of a state law or fraud enforcement agency.

State Law or Fraud Enforcement Agencies

A state law or fraud enforcement agency includes, but is not limited to: (1) a state law enforcement agency; (2) a state Medicaid fraud control unit (as defined in Section 1903(q) of the Social Security Act); and (3) a state agency administering (including those providing payment for services) or supervising the administration of a state health care program (as defined in Section 1128(h) of the Social Security Act).

State Licensing and Certification Authorities

The term state licensing or certification authority includes, but is not limited to, any authority of a state (or of a political subdivision thereof) responsible for the licensing or certification of health care practitioners (or of any peer review organization or private accreditation entity reviewing the services provided by health care practitioners), health care entities, providers, or suppliers. Examples of such state agencies include departments of professional regulation, health, social services (including state survey and certification and Medicaid single state agencies), commerce, and insurance. Boards of Medical Examiners.

State Licensing Boards

A state licensing board is a generic term used to refer to state medical and dental boards, as well as those bodies responsible for licensing, certifying, or otherwise authorizing physicians, dentists, and other health care practitioners to provide health care services. See also Boards of Medical Examiners.

State Medicaid Fraud Control Units

A state Medicaid fraud control unit (as defined in Section 1903(q) of the Social Security Act) is included in the definition of a state law or fraud enforcement agency.

Table B-3 provides examples of entities that may qualify as more than a single entity type for NPDB reporting and querying purposes.