Elevance Health
Associate General Counsel
Elevance Health, Chicago, Illinois, United States, 60290
Associate General Counsel - CarelonRxLocation : This position will work a hybrid model (remote and office). The ideal candidate will live within 50 miles of one of our Elevance Health PulsePoint locations.Elevance Health supports a hybrid workplace model with PulsePoint sites used for collaboration, community, and connection.This position will serve as an Associate General Counsel to CarelonRx, a pharmacy benefits manager (PBM) owned by Elevance Health, Inc., providing support on a variety of legal matters primarily to PBM's mail order and specialty pharmacies.How You Will Make an Impact:Primary duties include, but are not limited to:This role will serve on a team that provides substantive legal support to CarelonRx PBM's mail order and specialty pharmacies, including working with business leaders and legal department colleagues on a wide variety of strategy, commercial contracting, licensing, compliance, innovation, and regulatory matters relevant to PBMs and specialty and mail order pharmacies.Position requires a keen understanding of the business, legal and regulatory environment applicable to managing multi-channel pharmacy interests/risks, including but not limited to the following areas:
Specialty pharmacy drug procurement and services contracting, including LDD & exclusive distribution networks, REMS drugs/services, data reporting and HIPAA considerations, adherence and related pharmacy services contracting.340B contract pharmacy models, contracting and operational support, knowledge of HRSA and current landscape of legal and regulatory challenges to 340B pharmacy programs.State and federal regulations applicable to pharmacy facility and personnel licensure (e.g., Pharmacy, Pharmacist, Pharm Tech), including federal/state Controlled Substances regulations.Regulatory landscape applicable to drug procurement, distribution, wholesaling activities and relationships (e.g., DSCSA, wholesaler/TPL licensure).Specialty & mail order pharmacy enrollment/credentialing/accreditation.Knowledge of drug pricing models/methodologies and associated commercial and legal issues (e.g., WAC, AWP, NADAC, DIR, MAC pricing, other pricing methodologies).Review and regulatory counseling pertaining to advertising/marketing/promotional rules and regulations applicable to pharmacies and/or PBM-owned pharmacy assets.Fraud/waste/abuse and related white collar investigatory and regulatory counseling (e.g., AKS, CMP, HIPAA, Stark) on a variety of pharmacy-related issues.
Duties will require solid business acumen balanced with a sound risk mitigation mindset used to evaluate and articulate legal and commercial risks to business clients on a variety of matters with broad organizational impact and varying levels of risk.Must be able to navigate a complex and evolving regulatory environment by timely delivering sound, actionable legal advice on regulatory, strategic, and operational matters impacting owned pharmacies and PBMs.Manages and participates in extensive research of legal principles and precedent and consults with outside counsel where required on legal strategies on particular issues.Other legal duties and responsibilities as identified by senior management.Additional duties may include:Providing support on areas related to PBM/Pharmacy relations, including but not limited to:
Accreditation agencies and processes (e.g., URAC, ACHC, NABP, NCQA)State and federal regulations applicable to Commercial/Medicare/Medicaid lines of business and pharmacy compliance.Any Willing Provider and other pharmacy and network regulatory limitations (e.g., anti-mail & preferred networks allowed/not allowed).Providing support to PBM internal committees/processes relevant to PBM/Pharmacy networks (e.g., P&T, VAC, UM, PA).Wide variety of PBM/Pharmacy audit/appeals issues (e.g., MAC, FWA, CMS, Medicaid).PSAO contracting support.Familiarity with infusion provider/pharmacy relationships, models and associated regulatory challenges (e.g., provider models, AICs, home infusion, RN networks/licensure).M&A transactions in or involving the pharmacy sector (e.g., stock, asset purchase transactions, FWA due diligence).
Reporting to legal and business management on identified business exposure and associated risks as well as mitigation techniques being utilized.Providing legal support in the resolution of disputes and inquiries from customers, subcontractors, and governmental/regulatory/accreditation agencies.Serves as a resource for other attorneys and contract managers as well as business clients instructing and advising on technical and tactical issues.Minimum Requirements:Requires a JD, current license to practice law, and a minimum of 9 years of specific industry and/or technical legal experience post licensure; or any combination of education and experience, which would provide an equivalent background.Preferred Skills, Capabilities, and Experience:5-10 years of PBM, pharmacy or related healthcare experience, consistent with the duties of the position.At least 5 years of specific industry and/or technical legal experience post licensure; or any combination of education and experience, which would provide an equivalent background.Experienced and technically strong in drafting, reviewing, and negotiating contracts and related documents impacting pharmacies including 340B, LDDs, Payor, procurement of goods and services, etc.Proficient at preparing/delivering concise and timely briefings to business and legal management on assigned matters, including clear and well-developed communication skills.Possesses industry knowledge in one or more of the following areas consistent with essential duties of the position: pharmacy regulatory/licensing, specialty pharmacy drug procurement and manufacturer services contracting, wholesaler and related drug procurement matters, 340B regulatory and operational issues, PBM/reimbursement contracting, and operational models for specialty or mail order pharmacy.Detail-oriented, client-focused, and able to work effectively in a matrixed environment.Experience managing outside counsel and working within department budget and related administrative processes.Ability to manage work independently while keeping legal management appropriately informed and/or as requested.
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Specialty pharmacy drug procurement and services contracting, including LDD & exclusive distribution networks, REMS drugs/services, data reporting and HIPAA considerations, adherence and related pharmacy services contracting.340B contract pharmacy models, contracting and operational support, knowledge of HRSA and current landscape of legal and regulatory challenges to 340B pharmacy programs.State and federal regulations applicable to pharmacy facility and personnel licensure (e.g., Pharmacy, Pharmacist, Pharm Tech), including federal/state Controlled Substances regulations.Regulatory landscape applicable to drug procurement, distribution, wholesaling activities and relationships (e.g., DSCSA, wholesaler/TPL licensure).Specialty & mail order pharmacy enrollment/credentialing/accreditation.Knowledge of drug pricing models/methodologies and associated commercial and legal issues (e.g., WAC, AWP, NADAC, DIR, MAC pricing, other pricing methodologies).Review and regulatory counseling pertaining to advertising/marketing/promotional rules and regulations applicable to pharmacies and/or PBM-owned pharmacy assets.Fraud/waste/abuse and related white collar investigatory and regulatory counseling (e.g., AKS, CMP, HIPAA, Stark) on a variety of pharmacy-related issues.
Duties will require solid business acumen balanced with a sound risk mitigation mindset used to evaluate and articulate legal and commercial risks to business clients on a variety of matters with broad organizational impact and varying levels of risk.Must be able to navigate a complex and evolving regulatory environment by timely delivering sound, actionable legal advice on regulatory, strategic, and operational matters impacting owned pharmacies and PBMs.Manages and participates in extensive research of legal principles and precedent and consults with outside counsel where required on legal strategies on particular issues.Other legal duties and responsibilities as identified by senior management.Additional duties may include:Providing support on areas related to PBM/Pharmacy relations, including but not limited to:
Accreditation agencies and processes (e.g., URAC, ACHC, NABP, NCQA)State and federal regulations applicable to Commercial/Medicare/Medicaid lines of business and pharmacy compliance.Any Willing Provider and other pharmacy and network regulatory limitations (e.g., anti-mail & preferred networks allowed/not allowed).Providing support to PBM internal committees/processes relevant to PBM/Pharmacy networks (e.g., P&T, VAC, UM, PA).Wide variety of PBM/Pharmacy audit/appeals issues (e.g., MAC, FWA, CMS, Medicaid).PSAO contracting support.Familiarity with infusion provider/pharmacy relationships, models and associated regulatory challenges (e.g., provider models, AICs, home infusion, RN networks/licensure).M&A transactions in or involving the pharmacy sector (e.g., stock, asset purchase transactions, FWA due diligence).
Reporting to legal and business management on identified business exposure and associated risks as well as mitigation techniques being utilized.Providing legal support in the resolution of disputes and inquiries from customers, subcontractors, and governmental/regulatory/accreditation agencies.Serves as a resource for other attorneys and contract managers as well as business clients instructing and advising on technical and tactical issues.Minimum Requirements:Requires a JD, current license to practice law, and a minimum of 9 years of specific industry and/or technical legal experience post licensure; or any combination of education and experience, which would provide an equivalent background.Preferred Skills, Capabilities, and Experience:5-10 years of PBM, pharmacy or related healthcare experience, consistent with the duties of the position.At least 5 years of specific industry and/or technical legal experience post licensure; or any combination of education and experience, which would provide an equivalent background.Experienced and technically strong in drafting, reviewing, and negotiating contracts and related documents impacting pharmacies including 340B, LDDs, Payor, procurement of goods and services, etc.Proficient at preparing/delivering concise and timely briefings to business and legal management on assigned matters, including clear and well-developed communication skills.Possesses industry knowledge in one or more of the following areas consistent with essential duties of the position: pharmacy regulatory/licensing, specialty pharmacy drug procurement and manufacturer services contracting, wholesaler and related drug procurement matters, 340B regulatory and operational issues, PBM/reimbursement contracting, and operational models for specialty or mail order pharmacy.Detail-oriented, client-focused, and able to work effectively in a matrixed environment.Experience managing outside counsel and working within department budget and related administrative processes.Ability to manage work independently while keeping legal management appropriately informed and/or as requested.
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