Harsh P. Parikh

My focus

Healthcare Transactions

I assist clients in complex transactions involving sales and acquisitions of clinics, pharmacies, labs, and hospitals. My practice includes advising on entire health system affiliations and service line joint ventures among various types of providers. I represent healthcare entities in the regulatory aspects of healthcare transactions, including corporate structuring, diligence, licensure, reimbursement, and credentialing.

With deep experience handling regulatory issues implicated in healthcare transactions, I often serve as the regulatory counsel on a range of transactions involving state and federal agencies, including the Center for Medicare and Medicaid (CMS), California Attorney General (AG), California Department of Health Care Services (DHCS), California Department of Public Health (CDPH), California Department of Managed Healthcare (DMHC), the Medical Board of California (MBC), Federal Trade Commission (FTC), Food and Drug Administration (FDA), the Federal Drug Enforcement Agency (DEA), and the California State Board of Pharmacy.

Digital Health

I guide clients through developing innovative health delivery businesses and models, including value-based arrangements leveraging AI technology. My digital health experience includes counseling national telehealth platforms, publicly traded technology companies, and digital health startups on issues involving the practice of medicine, scope of practice (e.g., licensure, consent, doctor-patient relationship), reimbursement, corporate practice of medicine issues, and e-prescribing (including controlled substances). I was regulatory counsel on development of one of the first at-home COVID-19 testing solutions and CMS’s hospital-at-home models.

Regulatory Compliance

I regularly advise clients on compliance with federal and California healthcare laws (including pharmacy and controlled substances regulations). I am often asked to assess False Claims Act risk, appeal alleged overpayments, defend government investigations relating to Medicare and Medicaid (including Medi-Cal) billing, and resolve self-disclosure obligations under the Stark Law and Anti-Kickback Statute. I have successfully defended clients seeking resolution of government healthcare program overpayment issues through negotiated settlements. For example, I recently coordinated a major health system’s internal investigation of its billing practices and its voluntary self-disclosure to the Department of Health and Human Services, Office of the Inspector General. I’ve also led multiple compliance investigations and provider self-disclosures to federal and state agencies of issues involving unlicensed staff, improper medical record documentation, drug diversion, cost report errors, EMTALA violations, and HIPAA security breaches.

Managed Care Reimbursement

I advise on Medicare and Medicaid reimbursement/audit matters, including representing clients in administrative hearings and follow-on litigation. I’ve worked with some of the largest managed care organizations, physician groups, and specialty health plans to develop cutting-edge value-based reimbursement payment models. I also counsel large physician networks, including Independent Practice Associations (IPAs) and Medicare Accountable Care Organizations (ACOs), and health systems, on physician contracting, network, and revenue cycle management matters.

Looking ahead

The COVID-19 pandemic accelerated the adoption of digital technology in healthcare. There continue to be significant opportunities for integration of technology in the administration and delivery of health services. These tech-enabled advances will present complex legal challenges as traditional boundaries dissolve.

The need to achieve greater economies of scale will continue to drive consolidation in the industry for both payors and providers. Managed Medicare and Medicaid will continue to grow, as California becomes the first state to enact universal health coverage. The key will be whether lawmakers can balance the need to bend the cost curve without sacrificing innovation in medicine.

Insights

Publications

• “FAQs on Section 1135 Waivers: What Health Care Providers Should Know,” American Health Lawyers Association Publication, March 18, 2020
• “Proposed Rules Aim to Transform Key Federal Laws Restricting Health Care Agreements,” NH Bar News, January 15, 2020
• “Long-awaited proposed revisions to Stark Law, Anti-Kickback Statute and Civil Monetary Penalties tackle roadblocks to care coordination and value-based care,” Nixon Peabody Health Care Alert, October 17, 2019
• “Unpacking Republican Proposals to Roll Back Obamacare,” Los Angeles Daily Journal, December 12, 2016
• “Republican Plans to Reform the ACA,” San Francisco Daily Journal, December 12, 2016
• “CMS Releases Final Rules on MACRA Quality Payment Program Implementation for 2017–Onward,” Health Law ‘In The News,’ October 19, 2016
• “9th Circ. Closes More Doors On ACA Challenges,” Law360, October 10, 2014

Presentations

• Speaker, “Complex Health Information Privacy and Security: HIPAA and Beyond,” The California Society for Healthcare (CSHA) Fall Seminar, November 10, 2023
• Speaker, “Telehealth – Stark, AKS, and Compliance Minefield,” HCCA Orange County Regional Healthcare Compliance Conference, Anaheim, CA, June 9, 2023
• Speaker, “Metaverse: Future Reality or Myth? Analyzing Regulatory Implications,” ABA's Emerging Issues in Healthcare Law, San Diego, CA, March 9, 2023
• Moderator, “Realities of the Metaverse: Implications for the Healthcare Industry,” 11th Annual UCLA MedTech Partnering Conference, Los Angeles, CA, February 28, 2023
• Speaker, “2023 Healthcare Market Trends & Implications,” Nixon Peabody 2023 California MCLE Virtual Seminar, January 20, 2023
• Panelist, “Health Care Technology and the Law,” SABA-DC and SABA-North America's Health Law Sections, Webinar, October 28, 2022
• Panelist, “The Art of the Referral,” SABA's Law Partners Section, Webinar, October 19, 2022
• Moderator, “Minefields in developing AI in healthcare,” 10th Annual UCLA MedTech Partnering Conference, Los Angeles, CA, March 8, 2022
• Presenter, “Key Aspects of Social Media Marketing in Health Care,” West LegalEdcenter, Webinar, October 15, 2021
• Presenter, “Digital Health Licensure: Obstacles, Pitfalls and Opportunities for Cross-State Virtual Care Platforms,” 2021 CTel Digital Health Summit, June 9, 2021
• Presenter, “Final Stark AKS Rules,” Women in Health Administration of Southern California Webinar, March 16, 2021
• Moderator, “Should I Stay or Should I Go (to the doctor): Will Telehealth Outlive the Pandemic?” UCLA 9th Annual MedTech Partnering Conference, Webinar, March 9, 2021
• 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, “COVID-19 and the Mainstreaming of Telehealth, ”LACBA Healthcare Law Section, Webinar, June 3, 2020
• Presenter, “Telehealth Trends: Risks, Rewards and Reimbursement,” Health Care Compliance Association, Webinar, March 23, 2020
• 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.
• “Telehealth Trends: Risks, Rewards and Reimbursement,” Nixon Peabody LLP, Webinar, November 14, 2019
• “Health Care Reimbursement 101: Medicare and Medi-Cal,” Orange County Bar Association Health Care Law Section Meeting, Newport Beach, CA (August 8, 2019)
• “Disaster Preparedness and Response — What Your Clients Want You to Know,” California Society for Healthcare Attorneys (CSHA) 2018 Fall Seminar, Los Angeles, CA (November 9, 2018).
• “What Medical Staff Members Should Know About EMTALA,” [Confidential] Southern California Hospital Medical Staff (September 24, 2018).
• “Practice Essentials for Aspiring and Young Physicians,” American Association of Physicians of Indian Origin (AAPI) Winter Medical Conference, Las Vegas, NV (February 12, 2017, February 10, 2018).
• “Getting Heard: Working with the Updated Medicare Administrative Review Process,” American Bar Association, Health Law Section, On-Demand CLE Webinar (November 30, 2017).
• “Health Reform, Medicare, and Medicaid Under the Trump Administration: What Should We Expect?” South Asian Bar Association 14th Annual Convention, Washington D.C. (July 13–16, 2017).
• “Medicare Preemption in Managed Care Litigation,” California Association of Health Plan Legal and Regulatory Affairs Meeting, San Francisco, CA (May 17, 2017)