Health & Life Sciences

Telehealth

Hospitals, Clinics, and Other Health Care Facilities | Pharmacies | Health-care Focused Apps and Wearables | Investors and Start-ups | Technology Providers| Long-term Care| Health Insurance Companies | Physician Groups and Other Licensed Health Care Professionals

Technology in health care expands the horizon of what's possible and the laws are often steps behind. As the health care industry evolves there are opportunities for technology providers, as well as physicians, nurses, pharmacies, hospitals, and others to use or offer telehealth services in myriad ways in urban and rural settings, independent of geographic boundaries. Telehealth increases access to care or specialists, can improve quality, enhances the patient experience, and stretches limited resources. Telehealth touches nearly all aspects of health care and wellness by enabling people and systems to exchange health information for personal improvement, remote monitoring, consultative, diagnostic, and treatment services. And now, the COVID-19 pandemic has accelerated telehealth adoption throughout the industry.

Quarles & Brady's Telehealth Team includes attorneys who are licensed—or formerly licensed—health care providers, including pharmacists, a nurse, an EMT, and a physical therapist; those who have owned their own health care businesses; and an attorney with significant in-house counsel experience at a health care technology start-up, app, and pharmacy. Our on-the-ground experience helps us understand your business and perspective. We can assist with quickly implementing telehealth services in a variety of settings and involving different technologies, including transaction support, program design, implementation, compliance, regulatory, operational, and contractual matters.

Related Experience

Hospitals, Clinics, and Other Health Care Facilities

  • Drafting and negotiating agreements related to telehealth provider arrangements and partnerships
  • Assisting with licensure questions, contracting needs, operational management, data privacy and security issues, staff training, patient education, and payment and reimbursement questions
  • Updating policies and procedures to ensure credentialing processes are compliant
  • Advising regarding credentialing and licensure requirements when entering into telemedicine agreements
  • Advising on fraud and abuse issues and risks

Pharmacies

  • Navigating and ensuring compliance with state laws allowing pharmacy services to be provided remotely, including delivery through vending machines or kiosks, remote supervisions of technicians or other staff, and use of technologies for patient counseling
  • Advising on fraud and abuse issues and risks
  • Development of policies and procedures and compliance programs
  • Advising on licensure, recordkeeping, and operational requirements
  • Incorporating apps and texting into pharmacy practice

Health-care Focused Apps and Wearables

  • Nimble, business-focused strategic support for growth and compliance
  • Advising on software system requirements for health care services
  • Ensuring compliance with state laws on electronic data security
  • Determining whether the data is protected health information (PHI) or structuring arrangements to avoid business associate relationships where possible
  • Assisting in strategies related to FDA mobile medical device requirements
  • Advising on fraud and abuse issues and risks

Investors and Start-ups

  • Conducting due diligence in assessing the compliance of the program or service
  • Providing education about the health care industry and regulatory landscape
  • Advising on risk assessment and mitigation strategies, contracting, licensure (if applicable), and support as they scale
  • Advising on transaction strategies, and fraud and abuse issues and risks

Technology Providers

  • Counseling app developers and others about health care regulatory requirements, data privacy and security, and setting up new partnerships
  • Developing regulatory risk mitigation strategies
  • Developing compliance programs or related policies and procedures
  • Drafting contracts
  • Navigating the corporate practice of medicine, fee splitting, and kickback prohibitions
  • Advising on transaction strategies, and fraud and abuse issues and risks

Long-term Care

  • Counseling long-term care providers, including Medicare-certified skilled nursing facilities, assisted and independent living facilities, continuing care retirement communities, and home health and hospice providers using telehealth to provide patient care
  • Drafting and negotiating agreements related to telehealth provider arrangements and partnerships with long-term care providers, as well as advising regarding credentialing and licensure requirements when entering into agreements
  • Assisting with licensure questions, contracting needs, operational management, data privacy and security issues, staff training, patient education, and payment and reimbursement questions
  • Assisting with compliance related to the arrangement, mode of communication, or licensure related to utilizing telehealth platforms
  • Advising on fraud and abuse issues and risks

Health Insurance Companies

  • Navigating payment parity laws and licensure issues
  • Evaluating technologies for providing care that would be covered
  • Developing compliance or audit programs related to telehealth benefits management
  • Advising on state and federal laws around the different types of telehealth services, coverage and plan design requirements, and Medicaid and Medicare, including Medicare Advantage plan flexibility

Physician Groups and Other Licensed Health Care Professionals

  • Advising on licensure for professionals using telehealth to provide direct patient care, consult with other providers, or participating in telehealth arrangements in other ways
  • Assisting with compliance related to the arrangement, mode of communication, or licensure related to writing prescriptions
  • Contract drafting and transaction strategies
  • Advising on fraud and abuse issues and risks

The overarching requirements that govern many health care services and providers are also relevant to telehealth arrangements, including the corporate practice of medicine; state licensure, standard of care, and scope of practice laws; Anti-Kickback Statute; False Claims Act; HIPAA, HITECH, and Cures Act; Stark Law; Anti-Inducement Law; TCPA; and intellectual property protections.

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