Roma Sharma is a counsel in Crowell & Moring's Washington, D.C. office and a member of the firm's Health Care Group. Roma's practice entails counseling and representing health care providers, managed care organizations, distributors, pharmacies, laboratories, and other health care entities in various regulatory, transactional, and litigation matters. Roma primarily works with health care clients seeking to comply with federal and state laws and regulations, including those related to fraud and abuse (e.g., the Stark Law, the Anti-Kickback Statute, the False Claims Act – and state corollaries), telemedicine, licensing, reimbursement, the practice of medicine, and federal and state demonstration programs.
Recent representative engagements:
- Perform health care regulatory analysis of the business models and contracts of digital health technology companies – both nationally recognized and start-ups.
- Counsel telemedicine physician network and other entities on temporary Centers for Medicare & Medicaid (CMS) waivers and telemedicine rule changes during the COVID-19 declared public health emergency.
- Counsel health care entity on evaluating drive-through coronavirus testing opportunities and government outreach.
- Conduct internal investigation of managed care organization to analyze and determine compliance with Medicare Part D prescription drug regulations.
- Conduct health care regulatory due diligence for private equity firm in a $170 million transaction.
- Represent national inpatient rehabilitation facility (IRF) system in a multi-year False Claims Act Medicare billing investigation conducted by the Department of Justice, successfully reaching favorable settlement.
- Draft Medicare Shared Savings Program (MSSP) and Next Generation Accountable Care Organization (ACO) Model contracts and governance documents for ACOs and provide counsel on compliance and business issues.
- Counsel various health care entities on the fraud and abuse risks of proposed financial arrangements under the federal Stark Law and Anti-Kickback Statute.
- Prepare self-disclosures for submission to the CMS Self-Referral Disclosure Protocol (SRDP) on behalf of hospital systems, laboratories, and pharmacies.
- Defend Blue Cross and Blue Shield companies in national and statewide class actions asserting antitrust claims.
- Represent MedStar Health as an Interested Party in a Certificate of Need application.
In addition, Roma has an active pro bono practice. She currently represents an inmate in a state prison abuse action and also represents an affirmative asylum applicant. She previously represented a client seeking clemency and has represented several non-profit organizations, providing counsel on telemedicine and HIPAA.
Before joining Crowell & Moring, Roma interned with the Office of the General Counsel at the American Medical Association, the Health Care Bureau at the Illinois Office of the Attorney General, and the Federal Government Affairs and Public Policy division at Sanofi Pasteur. Roma graduated cum laude from The George Washington University Law School. She also holds a master in public health from The George Washington University Milken Institute, where she served as president of the Health Policy Student Association and was elected to the Delta Omega Honorary Society in Public Health.
Roma frequently writes client alerts, blog posts, and articles on emerging health information technology and fraud and abuse developments. She is an active member of the American Health Lawyers Association, the firm’s Diversity Council, and the Leadership Council on Legal Diversity (LCLD) Pathfinders class of 2020.
Affiliations
Admitted to practice: District of Columbia, Illinois
Speeches & Presentations
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"COVID-19 is Driving Telehealth Adoption: Understand the New Opportunities," Crowell & Moring Webinar
(April 29, 2020).
Presenters: Gary Baldwin, Jodi G. Daniel, Roma Sharma, and Stephanie D. Willis.
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"Healthcare Reimbursement: Commercialization Strategies and Approaches," 2018 Inova Discovery Series, Early Stage Investing in Health Technology
(June 21, 2018).
Presenters: Troy A. Barsky, Roma Sharma, and Maya Uppaluru.
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"Mega Rule Opportunities and Information About the Final Requirements for Participation," American Society of Consultant Pharmacists Webinar
(October 20, 2016).
Presenters: Troy A. Barsky and Roma Sharma.
Publications
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"OIG Issues Advisory Opinion Rejecting the Labeling of Test Tubes at No Cost," Crowell & Moring's Health Law Blog
(February 22, 2017).
Authors: Troy A. Barsky and Roma Sharma.
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"Connected Health is Here! Are You Ready?" AHLA Connections
(January 2017).
Authors: Jodi G. Daniel and Roma Sharma.
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"Medicaid Managed Care Final Rule: Prevention of Fraud, Waste, and Abuse," Crowell & Moring's Health Law Blog
(August 4, 2016).
Authors: Troy A. Barsky and Roma Sharma.
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"New Payment Models and Data: Changes and Themes to Watch," Crowell & Moring's Health Law Blog
(July 12, 2016).
Authors: Jodi G. Daniel and Roma Sharma.
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"CMS Proposes New ACO Performance Measures," Crowell and Moring's Health Law Blog
(March 3, 2016).
Authors: Troy A. Barsky and Roma Sharma.
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"CMS Announces Substantial Increase in ACO Participants for 2016," Crowell & Moring's Health Law Blog
(January 21, 2016).
Authors: Roma Sharma and Stephanie D. Willis.
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"South Florida Hospital System Settles Stark Allegations for $69.5 Million," Crowell and Moring's Health Law Blog
(November 17, 2015).
Authors: Troy A. Barsky and Roma Sharma.
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"Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions," Crowell & Moring's Health Law Blog
(November 16, 2015).
Authors: Jodi G. Daniel and Roma Sharma.
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"HRSA Proposes Rule on 340B Ceiling Pricing, Removes Orphan Drug Regulations and Sets Forth Civil Monetary Penalties," Crowell and Moring's Health Law Blog
(June 26, 2015).
Authors: Roma Sharma and Arthur N. Lerner.
Client Alerts & Newsletters
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"OIG Seeks Comment on Key Enforcement Parameters and Deadlines For Information Blocking; HHS Delays Enforcement,"
Health Care Alert
(April 29, 2020).
Contacts: Jodi G. Daniel, Roma Sharma, Maya Uppaluru, Stephanie D. Willis
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"Eligible Providers Can Now Apply for Telehealth Related Funding Through FCC COVID-19 Telehealth Funding Program,"
Health Care Alert
(April 15, 2020).
Contacts: Jacinta Alves, Jodi G. Daniel, Roma Sharma, Stephanie D. Willis, Shaina Vinayek
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"HHS Lifts Major Barriers to Telehealth to Help Reduce the Spread of COVID-19,"
Health Care Alert
(March 20, 2020).
Contacts: Troy A. Barsky, Jodi G. Daniel, Barbara H. Ryland, Stephanie D. Willis, Joe Records, Roma Sharma, Michelle Chipetine
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"Coronavirus (COVID-19) Emergency Spending Measure Waives Medicare Telehealth Restrictions,"
Health Care Alert
(March 10, 2020).
Contacts: Jodi G. Daniel, Roma Sharma
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"11th Circuit Issues Long-Awaited Opinion in AseraCare Affirming that Mere Differences in Reasonable Clinical Judgement Cannot Be False Under the FCA and Remanding for New Trial and Consideration of Full Record,"
Health Care Alert
(September 13, 2019).
Contacts: Jacinta Alves, Brian Tully McLaughlin, Nkechi Kanu, Roma Sharma, G. Meredith Parnell
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"HHS Proposed Rule Takes Aim at Drug Rebates from Manufacturers to Health Plans/PBMs, Proposes Safe Harbors to Pass Savings to Consumers and Protect Some Manufacturer-PBM Payments,"
Health Care Alert
(February 1, 2019).
Contacts: Barbara H. Ryland, Todd D. Rosenberg, A. Xavier Baker, Troy A. Barsky, Roma Sharma
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"Changes to the CMS Self-Referral Disclosure Protocol: Continuing Challenges & Issues Providers Need to Address Before Disclosure,"
Health Care Alert
(June 5, 2017).
Contacts: Troy A. Barsky, John T. Brennan Jr., Jacinta Alves, Stephanie D. Willis, Roma Sharma
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"Managed Care Lawsuit Watch - March 2016,"
Managed Care Lawsuit Watch
(March 29, 2016).
Contacts: Christopher Flynn, Peter Roan, Roma Sharma, Rochelle-Leigh Rosenberg, Brian C. Lewis, Lauren R. Nunez
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"Key Takeaways from HIPAA Guidance on Individuals' Rights to Access Health Information,"
Regulatory Alert
(January 21, 2016).
Contacts: Jodi G. Daniel, Roma Sharma
Media Mentions
Firm News & Announcements