Rebecca Simone

What do you focus on?

My practice covers various areas of regulatory compliance and transactional work. Leveraging my industry knowledge and prior experience as in-house counsel for a publicly traded pharmacy benefits manager, today I mainly focus in three areas.

Health Care Transactions

I’ve acted as health care regulatory counsel on mergers and acquisitions of both public and private health care entities and regularly work on joint ventures and other contractual arrangements such as employment agreements, professional services agreements and license/lease arrangements. I work closely with both health care providers and health care management companies on such transactions and advise clients on underlying licensure, fraud and abuse and other regulatory issues. I am currently working with several clients that are involved in the world-wide response to the COVID-19 pandemic, including COVID-testing companies, laboratories and physician practices.

Fraud and Abuse

I regularly counsel our health care clients on navigating their practices/businesses within the confines of the federal Anti-Kickback Statute, the federal Stark law and state law equivalents. I have successfully obtained Advisory Opinions from the Department of Health and Human Services Inspector General regarding compliance with the Anti-Kickback Statute. I also work with clients that are responding to inquiries, such as subpoenas and civil investigative demands, from regulatory agencies. I have significant experience with pharmacy/pharmaceutical manufacturer issues and patient assistance programs.

Health Information Privacy/HIPAA

I work with clients that have experienced data breaches or are undergoing HIPAA investigations. Additionally, I help clients bring their policies and practices into compliance with HIPAA.

What do you see on the horizon?

COVID-19 is arguably the top health care priority in the United States and has impacted all entities and individuals in the health care space in some way. I expect to see innovation from health care technology companies and health care providers to continue to adapt to this changing environment. However, as is often the case in health care, technology moves faster than regulation. I am currently counseling several clients on operating their COVID-19-related services and businesses in a compliant manner. I expect to see increased enforcement activity and government investigations related to allegations of companies/providers fraudulently taking advantage during the pandemic.

Publications and presentations

• Presenter, “Real Talk: How the Revised Stark and AKS Rules Will Impact Health Industry Compliance,” American Bar Association, Webinar, January 12, 2021
• Presenter, “Final Changes to Stark Law and Anti-Kickback Statute Regulations: What Your Organization Needs to Know,” Nixon Peabody LLP, Webinar, January 6, 2021
• Presenter, “Proposed Changes to Stark Law and Anti-Kickback Statute Regulations – What Your Organization Needs to Know About These and Other New HHS Initiatives,” Health Care Compliance Association (HCCA) Webinar, February 18, 2020.
• Presenter, “Stark Law, AKS, and CMP Law Changes: Expanded AKS Safe Harbors, Narrowing Stark Law—Proposed Stark and AKS Protections to Facilitate Value-Based Arrangements and Care Coordination,” Strafford Webinar, February 4, 2020.
• “State Response to Opioid Crisis and Opioid Prescribing Requirements: A 50 State Survey,” AHLA, November 2019
• “Practical Policies to Develop Internal Controls and Minimize Compliance Risk,” PAP 2019 20th Annual Patient Assistance & Access Programs, March 2019
• “OCR seeks public comments on potential HIPAA revisions to encourage care coordination,” Nixon Peabody HIPAA Law Alert, December 14, 2018
• “Navigate the Differences in Providing Assistance for Government vs. Commercial Patients,” CBI PAP Legal Update, September 2018 (Moderator)
• “Trump signs telemedicine law related to prescribing controlled substances,” Nixon Peabody Health Care Alert, November 7, 2018
• “CMS seeks input on the regulatory burden of the Stark law and ideas for possible changes,” Nixon Peabody Health Care Alert, June 25, 2018
• “OIG releases new final rules related to the Anti-Kickback Statute and Civil Monetary Penalties Law,” Nixon Peabody Health Care Alert, December 15, 2016
• “What’s trending on NP Privacy Partner,” NP Privacy Partner, July 8, 2016
• “What’s trending on NP Privacy Partner,” NP Privacy Partner, June 10, 2016
• “Renewed focus on managed care, program compliance in the OMIG's newly released 2016–17 work plan,” Nixon Peabody Health Care Alert, May 12, 2016
• “What’s trending on NP Privacy Partner,” NP Privacy Partner, April 8, 2016
• “NYS health commissioner uses discretion to issue blanket waiver to e-prescribing mandate in ‘exceptional circumstances,’” Nixon Peabody Health Care Alert, March 18, 2016
• “New York State e-prescribing mandate effective March 27, 2016; no further delay is expected,” Nixon Peabody Health Care Alert, March 2, 2016
• “Physician compensation arrangements on OIG radar,” Nixon Peabody Health Care Alert, June 11, 2015
• “Internal Investigations: Shining the Spotlight on the Role of the Attorney-Client Privilege,” Health Care Compliance Forum, Nixon Peabody LLP, New York, New York, March 24, 2015 (Moderator)
• “NYS Department of Financial Services (DFS) issues guidance on surprise bills for health care services,” Nixon Peabody Alert, March 24, 2015
• “New York’s Surprise Medical Bill Law: Three things health care providers need to know before March 31,” Nixon Peabody Alert, January 28, 2015
• “CMS releases revised 855R Application for Reassignment of Medicare Benefits,” Nixon Peabody Alert, December 2, 2014
• “Self-Disclosing Medicare and Medicaid Overpayments,” Health Care Compliance Forum, Nixon Peabody LLP, New York, New York, October 7, 2014 (Moderator)
• “NY Surprise Medical Bill Hits Out-Of-Network Providers,” Law360, June 12, 2014
• “OIG updates guidance on charity patient assistance programs,” Nixon Peabody Alert, June 5, 2014
• “New York's surprise medical bill law,” Nixon Peabody Alert, June 3, 2014
• “HHS clarifies health insurance exchanges are not federal health care programs,” Nixon Peabody Alert, November 11, 2013
• “CMS issues policy memorandum regarding assignment of Medicare provider agreements following CHOW,” Nixon Peabody Alert, October 3, 2013
• “New York State OMIG reminds providers to implement effective compliance plans,” Nixon Peabody Alert, July 27, 2012