Harsh works with managed care organizations, hospital systems, life sciences companies, and other healthcare providers on a wide range of regulatory, reimbursement, and transactional matters. With extensive experience in corporate boardrooms, courtrooms, and before administrative agencies across the United States, Harsh guides public and private organizations on a variety of business arrangements with health plans, physicians, behavioral health providers, hospitals, hospices, nursing facilities, and drug and device manufacturers.
His practice encompasses federal and California fraud and abuse compliance, licenses and permits, Medicare and Medicaid (Medi-Cal) participation and reimbursement, False Claims Act internal and government investigations, and enforcement actions. Harsh also advises clients on health information technology, bioethics, privacy, security compliance, digital health, and telemedicine matters.
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.
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.
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.
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.
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.
University of California, Los Angeles, B.A.
University of California, Los Angeles School of Law, J.D.
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