Andrew Ruskin is a partner in the firm's Washington, D.C. office. He is a member of the Health Care and FDA practice group. Andy’s practice concentrates on the myriad ways that Medicare and Medicaid reimbursement and compliance shape the U.S. health care ecosystem. Medicare and Medicaid regulations impact how health care providers and suppliers, and the entities that sell to them, such as drug and device manufacturers, structure themselves and their arrangements with each other. Health care and life sciences clients regularly seek Andy’s counsel on developing strategies that simultaneously address regulatory challenges while achieving organizational objectives. With almost a quarter century of practice representing clients in this area, Andy has examined, and solved for, a vast array of healthcare regulatory issues. His deep market knowledge allows Andy to simultaneously provide macro and micro perspectives on a health care client’s most challenging concerns.
For health care providers, Andy provides practical guidance on compliance with a wide range of regulatory requirements, including the Provider Based Rule, rules governing graduate medical education, 340B compliance, and clinical trial reimbursement rules. Andy also provides experienced counsel on elections made for wage index purposes, including navigating rules pertaining to submissions to the Medicare Geographic Classification Review Board and to the CMS Regional Office for wage index and rural redesignations. Andy works with clients to closely examine billing rules to determine whether they have repayment obligations under the 60 Day Repayment Rule and assists in developing Compliance Program safeguards. Where clients disagree with the government’s assessment of their entitlement to payment, Andy represents them before regulatory tribunals, including the Provider Reimbursement Review Board, and defends them in Federal court proceedings and government investigations against claims involving False Claims Act liability. The complex regulatory requirements also serve as a backdrop to the advice he gives to clients when they seek his counsel developing provider affiliation agreements, joint venture agreements, and provider acquisitions.
For drug and device manufacturers, Andy serves as a Market Access professional. His understanding of the drivers of Medicare and Medicaid payment, including Price Reporting concerns, and the program integrity risks associated with these payments, such as Anti-Kickback Statute and False Claims Act risk, allows him to be highly effective at negotiating agreements with distributors, group purchasing organizations, payors, 3PLs, and customers, as well as in presenting matters to the Centers for Medicare & Medicaid Services, where reimbursement for a product may not yet be optimal, in light of its value. Andy has appeared before the HCPCS Committee to assist with obtaining a new code. He also advises these entities on their Price Reporting policies, and Market Access policies, including their business rules pertaining to patient assistance programs, copay cards, and payments to foundations. Andy also assists with healthcare regulatory due diligence and strategizing for manufacturers seeking to acquire a product. Additionally, he defends manufacturers from False Claims Act liability where sales or marketing practices have been challenged.
A recognized thought leader and an active member of industry organizations, Andy serves as the current Chair of the American Health Law Association’s Institute on Medicare and Medicaid Payment Issues, is a member of the Health Law Advisory Committee to Wolters Kluwer CCH, and is on the Editorial Advisory Board to HCCA’s Report on Medicare Compliance. He is a sought-after speaker on current developments in Drug Pricing for such industry organizations as the American Conference Institute.
Prior to joining the firm, Andrew counseled hospitals, pharmaceutical and medical device companies, and Medicare Advantage plans on a range of Medicare and Medicaid regulatory, litigation, and transactional matters. He advised on strategic issues surrounding coverage, reimbursement, and compliance, as well as drug pricing and price reporting. He defended clients in investigations by the U.S. Attorney’s Office and the Department of Health and Human Services Office of Inspector General. He has also appeared before several regulatory tribunals, such as the Provider Reimbursement Review Board and the HCPCS Committee.
- “Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates,” American Conference Institute, 17 November 2022
- “Medicare Part B Drug Pricing,” American Conference Institute, 8 November 2022
- “Fraud & Abuse in the Sales and Marketing of Drugs & Medical Devices,” American Conference Institute, 20 July 2022
- “Hospital Charges under the Microscope: Impact of Price Transparency Rule and No Surprises Act,” AHLA Annual Meeting, 27-29 June 2022
- ACI’s Annual RX Drug Pricing Boot Camp, American Conference Institute, 11 and 12 May 2022
- ACI’s “BIG FOUR” Pharmaceutical Pricing Boot Camp, American Conference Institute, 18 and 19 May 2022
- “Provider-Based Status, Under Arrangements, Enrollment, and Related Medicare Requirements,” AHLA Institute on Medicare and Medicaid Payment Issues, 23-25 March 2022
- "Medicare Part B Drug Pricing," American Conference Institute, 17 November 2020
- "Price Transparency Rule Compliance, Informing the Patient, and Protecting the Hospital’s Commercial Interests: Mutually Exclusive Concepts?" AHLA Physicians and Hospitals Law Institute, 10-11 February 2020
- "Limits on Agency Action by the Department of Health and Human Services: Impact on Providers in 2020 and Beyond," American Health Law Association
- "Provider-Based Status, Under Arrangements, Enrollment, and Related Medicare Requirements," AHLA Institute on Medicare and Medicaid Payment Issues, 20-22 March 2019
- "Provider-Based Status, Under Arrangements, Enrollment, and Related Medicare Requirements," AHLA Institute on Medicare and Medicaid Payment Issues, 21-23 March 2018
- "60-Day Repayment Rule: Implications for Internal and External Audits," AHLA Annual Meeting, June 2018
- "What’s the Future of the CMS 60-Day Repayment Rule?" AHLA Physicians and Hospitals Law Institute, February 2018
- "Don’t put the CAR-T before the Horse: Proper Planning for Novel Gene Therapies in an Uncertain Regulatory Environment"
- "Provider-Based Status under Siege: Do the Benefits Justify the Costs of Compliance?" Fraud and Compliance Forum, October 2017
- "Hospital-Based Status Post BBA Section 603: Is Expansion Still Possible?" AHLA Annual Meeting, June 2017
- "Provider-Based Status: What a Long, Strange Trip It’s Been!" AHLA Institute on Medicare and Medicaid Payment Issues, 23-31 March 2017
- "What Every AMC Needs to Know About the 340B Program," AHLA Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, 9-10 March 2017
- "Medicare Part B: Drug Pricing, RX Drug Pricing Master Course," American Conference Institute, 1-2 November 2016
- "Strategic Planning for Physician Practice Acquisitions in the Post-Site Neutrality Payment Era," American Health Lawyers Association
- Editor, "Price Transparency Rules," American Health Lawyers Association
- "60-Day Repayment Rule: Implications for Internal and External Audits," American Health Lawyers Association
- "60-Day Overpayment Rule Medicare Parts A and B," American Health Lawyers Association
- "Don’t put the CAR-T before the Horse: Proper Planning for Novel Gene Therapies in an Uncertain Regulatory Environment," American Health Lawyers Association
- "Provider-Based Status, Under Arrangements, Enrollment and Related Medicare Requirements," American Health Lawyers Association
- "Provider-Based Status under Siege: Do the Benefits Justify the Costs of Compliance?" American Health Lawyers Association
- "What Every AMC Needs to Know about the 340B Program," American Health Lawyers Association