Covered Functions definition

Covered Functions means those functions of a Covered Entity the performance of which makes the entity a health plan, health care provider, or health care clearinghouse.

Covered Functions means the functions performed by a covered entity which make the covered entity a health plan, health care clearinghouse, or health care provider.

Covered Functions shall have the same meaning as the term “hybrid entity” in 45 CFR §160.103.

Examples of Covered Functions in a sentence

• By December 31, 2012, GSK shall provide to managers of employees performing Covered Functions and supervisors of sales personnel (collectively “Management”) at least three hours of specialized compliance-related training applicable to the functional area of the manager (Management Compliance Training).

• Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”).

• In the event that, after the Effective Date, GSK purchases or establishes a new business unit or location related to or engaged in any of the Covered Functions or in cGMP Activities, GSK shall notify OIG no later than five days after the date that the purchase or establishment of the new business unit or location is publicly disclosed by GSK.

• In the event that, after the Effective Date, GSK changes locations or closes a business unit or location related to or engaged in any of the Covered Functions or in CGMP Activities, GSK shall notify OIG of this fact as soon as possible, but no later than within 30 days after the date of change or closure of the location.

• More specifically, the IRO(s) shall conduct reviews that assess GSK’s systems, processes, policies, procedures, and practices relating to the Covered Functions (including Research and Publication Practices and Authorship-Related Practices) and the TRACER program (collectively “IRO Reviews”).

More Definitions of Covered Functions

Covered Functions refers to “Compounding/Manufacturing Functions,” “Distribution Functions,” “Specialty Distribution and GPO Functions,” “Pharmacy Functions,” and “Consulting Services Functions,” collectively.‌

Covered Functions includes: (a) the selling, marketing, advertising, promoting, or branding of Government Reimbursed Products; (b) the preparation or external dissemination of promotional materials or information about, or the provision of services relating to, Government Reimbursed Products, including those functions relating to RMS’s review and approval processes for promotional materials and any applicable review committee(s); (c) the preparation or external dissemination of non-promotional materials about Government Reimbursed Products, including those functions relating to RMS’s review and approval process for any non-promotional materials and any applicable review committees; (d) contracting with health care professionals (HCPs) for consulting services (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and any research-related activities, and authorship of articles or other publications relating ot Government Reimbursed Products), or other fee-for service arrangements relating to Government Reimbursed Products; (e) reviewing and/or approving requests for grants or charitable contributions.

Covered Functions includes: (a) the selling, marketing, advertising, promoting, or branding of Government Reimbursed Products; (b) the preparation or external dissemination of promotional materials or information about, or the provision of services relating to, Government Reimbursed Products, including those functions relating to Arthrex’s review and approval processes for promotional materials and any applicable review committee(s); (c) the preparation or external dissemination of non-promotional materials about Government Reimbursed Products, including those functions relating to Arthrex’s review and approval process for any non-promotional materials and any applicable review committees; (d) contracting with health care professionals (HCPs) or health care institutions (HCIs) (health care institutions) for consulting services (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and any research-related activities, and authorship of articles or other publications relating to Government Reimbursed Products), or other fee-for service arrangements relating to Government Reimbursed Products; (e) reviewing and/or approving requests for grants or charitable contributions; and (f) contracting with HCPs or HCIs for the purchase or licensing of intellectual property or for the payment of royalties for intellectual property contributions to the development of a product, technology, process or method.‌

Covered Functions means all activities that involve the preparation or submission of Premarket Approval Applications (PMAs) to the FDA and all communications (initial and supplemental) with the FDA about PMAs and the component elements of PMAs, including but not limited to any performance standards applicable to Government Reimbursed Products Advanced Bionics relied upon in those submissions.

Covered Functions includes: (a) the selling, marketing, advertising, promoting, or branding of Government Reimbursed Products, including the negotiation of contracts for the purchase of Government Reimbursed Products and direct- to-consumer sales of Government Reimbursed Products; (b) the preparation or external dissemination of promotional materials or information about, or the provision of services relating to, Government Reimbursed Products, including those functions relating to Essilor’s review and approval processes for promotional materials and any applicable review committee(s); (c) the preparation or external dissemination of non-promotional materials about Government Reimbursed Products, including those functions relating to‌‌ Essilor of America, Inc. and Essilor Laboratories of America, Inc. Corporate Integrity Agreement Essilor’s review and approval process for any non-promotional materials and any applicable review committees; (d) contracting with eye care professionals, including optometrists, opticians or ophthalmologists (ECPs) or entities that (i) employ or contract with ECPs, (ii) manage or operate optical or ophthalmology practices, or (iii) otherwise provide optical care or services (referred to herein as Eye Care Institutions or ECIs for any Co-Marketing Activity; and (e) reviewing and/or approving requests for grants or charitable contributions.

Covered Functions includes: (a) the selling, marketing, advertising, promoting, or branding of Government Reimbursed Products; (b) the preparation or external dissemination of promotional materials or information about, or the provision of services relating to, Government Reimbursed Products; (c) contracting with health care professionals (HCPs) for consulting services (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and any research-related activities, and authorship of articles or other publications relating to Government Reimbursed Products), or other fee- for service arrangements relating to Government Reimbursed Products; (d) contracting with HCPs or health care institutions (HCIs) for any Co-Marketing Activity; and (e) reviewing and/or approving requests for grants or charitable contributions involving HCPs or HCIs.

Covered Functions means those functions of a covered entity the performance of which makes the entity a health plan, health care provider, or health care clearinghouse.