HEALTH | Marc Cunningham LLC

Health

Negotiation and drafting of agreements, contracts, documents and templates, for all areas of healthcare and pharmaceutical operations, such as for example: academic medical center (AMC); academic research organization (AROs) accountable care organizations (ACOs); confidentiality (CDA); consultant services; data analytics; data licensing; data privacy; data security; distribution; distributor (full-line, international, regional, national, specialty]; emergency (or experimental) investigational new drug (EIND) applications; group purchasing organization (GPO); integrated delivery network (IDN); investigational new drug (IND) applications; manufacturing; non-competition (NCA); non-disclosure (NDA); non-solicitation (NSA); operations (domestic, international and market-level); outsourcing; personal information (PI in the European Union – EU); personally-identifiable information (PII in the United States – US); pharmacy pricing; sourcing; subject matter expert (SME); supply; treatment investigational new drug (TIND) applications; vendor; wholesaler.

Application of various academic, business and philosophical principle systems to health and pharmaceutical legal issues, such as: change management; health information management (HIM); Six Sigma program and project management principles; strengths, weaknesses, opportunities, threats (SWOT) analysis.

Legal support for the thought processes involved in the commercialization and e-commercialization of science innovation and scientific research, such as: all intellectual property (IP) functions; research and position papers regardingthe pro and con arguments involving open science versus science commercialization.

Overall domestic and international experience with the entire spectrum of innovative pharmaceutical environment initiatives, such as: advocating for bringing drug manufacturing back to the US through legal support for new contracting opportunities in states with depressed employment; enhancing accessibility to drugs and prescription medications through legal support for the establishment of new affordability programs (funded through participation by the drug manufacturers, and state and Federal government grants and loans); consolidating, relocating, renovating, or building new centralized facilities for ambulatory, outpatient or pharmacy services; efforts to increase affordability by pricing options, such as rebates and reimbursement; facilitating external and internal enforcement efforts to remediate faulty controls, equipment, maintenance, records management, standard operation procedures (SOPs) and testing.

Experience with hub services, including the services of pharmacy benefits managers (PBMs) and specialty pharmacy providers (SSPs), which allow a manufacturer to have a single point of contact with patients who utilize the manufacturer’s therapeutics, and which may provide various other services to assist patients, such as: benefits investigation; bridge supplies; compliance with risk evaluation and mitigation strategies (REMS); COVID-19 support; data reporting; drug delivery and administration support; financial and co-pay assistance; patient education; prescription triaging; prior authorization processing.

Legal support for the implementation and maintenance of various patient support services programs, such as for: billing; classifications; coding – such as current Procedural Terminology (CPT), healthcare common procedure coding system (HCPCS), or the World Health Organization (WHO) International Classification for Diseases (ICD) – patient coding; coverage analysis; COVID-19 support; field support; government liaison; private payer services.

Centers for Medicare & Medicaid Services (CMS) issues, such as compliance, contracts, interactions (including Medicare savings verification) and qualifications.

Experience with contractual and operational interactions between hospitals and IDNs, particularly regarding the legal sub-ecosystems created by the various groups of specialized physicians operating within the established legal ecosystems of the hospitals.

Legal support for brand development, brand launch and brand marketing strategies, such as for example,those broadly-outlined in the Ansoff Matrix – diversification; market development; market penetration; and, product development – which may be achieved through a combination of activities, such as: account-based marketing (ABM); affiliate marketing; content marketing; customer acquisition strategy; customer engagement; customer retention strategy; differentiation strategy; direct business-to-business (B2B) sales by trained specialized personnel; email marketing; inbound marketing; list-building; market segmentation; multi-channel marketing; product positioning; revenue model strategy; service positioning; search engine optimization (SEO); social media marketing; target marketing; value propositioning.

Legal support for all commercialization activities of the medical affairs department, such as: advertising and promotional content review; assisting the branding team formulate scientific strategies; arranging speaker programs; collecting relevant market intelligence and then disseminating it throughout the enterprise to relevant personnel; communications; compliance coordination; content creation; coordination discussions at medical conventions; determining the necessity for any further clinical trials; execution of economics and outcome studies to evaluate how the use of a drug may affect medical costs and patient quality of life; external dissemination to potential healthcare providers the advantages of a drug after it has successfully-completed clinical trials; formulating a publication plan for any new product; fostering relationships with key industry opinion leaders (such as academic researchers and expert practitioners in relevant fields of medicine); information creation as the internal liaison between the commercial departments and research and development (R&D); providing internal product training to relevant personnel; responses to regulatory audits and investigations; responses to questions from government and healthcare providers (HCPs); sponsoring product education presentations for relevant organizations and practitioners; vetting clinical trial proposals from independent investigators to determine whether to support such proposed clinical trials financially.

Legal support for all speaker program issues, such as: accommodations; contracts; compliance with Department of Health and Human Services (HHS) Office of Inspector General (OIG) guidelines (regarding fraud & abuse, false or misleading representations and the like); ethics; invitees; location; logistics; proposed content; remuneration (if any).

Legal support for issues regarding the individuals and entities specified on the HHS OIG List of Excluded Individuals and Entities (LEIE).

Legal support for all pharmaceutical issues (such as clinical trials, compliance, contracts, distribution, government affairs, litigation, logistics, manufacturing, price reporting, pricing, pricing standards, regulatory, reimbursement, and the like) in the domestic and international pharmaceutical markets, such as in the: Asia/Pacific (APAC); cross-border (Canada and Mexico); Europe, Middle East, Africa (EMEA); EU; Latin America Division (LAD); Pacific Rim (Australia, Japan, Philippines, South Korea, Taiwan); South America; US Federal sector; US private sector.

Experience with specialty pharmacy (SP) marketing tactics, as related to the CMS Part B Drug Payment Model and 340B Pricing Program, such as: brown-bagging (in which a patient picks up a prescription drug at a regular pharmacy and then takes the drug to the HCP's office, where the HCP administers the drug to the patient, then submits a claim for reimbursement for the HCP’s medical services, and then the SP adjudicates the claim and collects any copayment or coinsurance from the patient before treatment); buy-and-bill (in which an HCP purchases a drug directly from a pharmaceutical wholesaler or SP, and after administering the drug, submits a claim for reimbursement for both the drug and any other medical services by the HCP); and, white-bagging (in which an SP ships a drug directly to an HCP, who holds it on behalf of the patient until patient pickup, then the HCP submits a claim for reimbursement for both handling services and any other medical services by the HCP, and then the SP adjudicates the claim and collects any copayment or coinsurance from the patient before treatment).

Experience with basic types of compliance, financial, operational and strategic pharmaceutical risk management issues, such as: 340B program; brand protection; counterfeit drugs; developing new drugs for the drug pipeline as quickly as possible; disruptive innovation; drug shortages; entrenched and unwavering management culture; escalating drug development costs; global quality control; healthcare reform; increased competition; increased customer efficacy expectations; patent cliffs (the sharp decline in revenue or profitability when a company’s expire, leaving the revenue stream from the covered drug vulnerable to generic knock-offs by other companies); criminal or product liability for defective or addictive products (and the resulting cover-ups therefore); reputation dilution; stagnant scientific productivity; sterile compounding; supply chain disruption; technology obsolescence; uncertain availability of funds; unstable domestic and international work force.

Experience with the World Health Organization (WHO) quality risk management (QRM) guidelines, which outline a systematic process for the , control communication, and review of to the of product throughout the product life-cycle.

Experience in branded, generic (unbranded) and over-the-counter (OTC) pharmaceuticals.

Legal support for health economics and outcomes research (HEOR).

Consultation regarding the advertising and promotion of branded pharmaceutical products.

Advocate for the continuing use of the efficient contracting methodology for all types of contracts.

Extensive procurement, recommendation, research, testing, use of various software management platforms, such as for: bid management (BMS) (such as for: estimating; management; submissions; tracking); compliance management (CMS); computer systems validation (CSV); content management (CMS); contracts management (CMS); electronic health records (EHR) management; electronic medical records (EMR) management; FDA validation (FDAV); healthcare compliance management (HCM); healthcare management (HMS); legal management (LMS) (such as for: billing; calendaring; case tracking; document management; law practice management; research); logistics management (LMS); manufacturing management (MMS); medical practice management (MPM); outsourcing management (OMS); pharmaceutical compliance management (PCM); pharmaceutical customer relationship (PCRM); pharmaceutical drug inventory management (PDIM); pharmaceutical management (PMS); pharmaceutical manufacturing management (PMM); pharmacy management (PMS); process validation (PVS); project management (PMS); quality management (QMS); software validation (SVS); sourcing management (SMS); supply chain management (SCM); tender management (TMS); vendor management (VMS); warehouse management (WMS).

Domestic and international experience with clinical trials, life sciences, managed care, medical devices, pharmacies and many other areas of healthcare-related practice.

Legal support regarding health-related issues in advertising, press releases, promotional matters, procurement, IT, maintenance, facilities, accounting and HR regarding domestic and international contractual issues.

Provided training for all team members regarding the health-related legal aspects of contracts, agreements, sales, marketing and general behavior when interacting with clients, customers, patients and third-parties.

Experience with contract development manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs).

Last updated 210509_1258