Healthcare Regulatory Compliance

Why Work With an Attorney for Healthcare Regulatory Compliance?

If you feel overwhelmed by the regulatory framework your operations must adhere to, you certainly are not alone. Even one small oversight or misstep can expose you to legal action, fines, and reputational damage. Yet healthcare regulations change constantly, often outside of busy healthcare providers’ awareness. 

I help medical providers and practice owners maintain compliance to protect themselves and their patients. By partnering with me, you gain access to a highly experienced legal professional equipped with wide-ranging knowledge about the evolving regulatory landscape. I will be your trusted guide through shifting regulatory concerns and compliance matters to help you:

• • Ensure patient safety and quality of care
  • Avoid non-compliance consequences like legal action, fines, and even criminal charges
  • Protect patient data privacy and security
  • Uphold ethical and professional integrity standards
  • Protect your organization’s reputation through a strong compliance program 

My Areas of Practice

Allow me to untangle the intricate web of healthcare regulatory compliance laws governing your healthcare practice to ensure comprehensive adherence. My knowledge of the legal landscape extends to each of these key areas and regulations affecting medical providers like you. 

Fraud, Waste, and Abuse (Anti-Kickback and Self-Referral Laws)

• • Fraud, Waste, and Abuse (FWA) in healthcare is governed by the federal Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law), as well as similar state laws. 

The AKS is a civil and criminal statute that prohibits payments in exchange for referrals and applies to services covered by federal healthcare programs, such as Medicare or Medicaid. he Stark Law prohibits physicians from referring patients to an entity for “designated health services” payable by Medicare or Medicaid if there is an ownerhsip or financial relationship between the provider and the healthcare organization. 

I help healthcare providers identify and prevent potential violations of FWA laws. I review business relationships and transactions for compliance with federal and state anti-kickback and self-referral laws. I can also conduct a legal audit of your operations to look for red flags and help you create a compliance program that prevents future missteps. I will help you understand legal exceptions or “safe harbors” to these laws and ensure that your arrangement meets the specifications of each, if applicable. 

HIPAA, Privacy and Security

The federal Health Insurance Portability and Accountability Act (HIPAA) is the cornerstone of healthcare privacy and security rules to protect patient health information. 

• The HIPAA Privacy Rule sets standards to protect patients’ medical records and protected health information (PHI).

• The HIPAA Security Rule sets standards to secure patients’ electronic personal health information. 

I guide medical providers through the full HIPAA compliance landscape, including comparable state privacy and security rules, to promote long-term practice adherence and success. My role often involves developing compliance plans, conducting risk analyses, and creating policies and procedures. I review and draft a wide range of HIPAA procedural documents, including privacy and security policies, consent and authorization forms, and breach notification documents. 

Telehealth

Telehealth services come with their own regulatory compliance considerations. Many healthcare providers are still adapting to telehealth regulations or are hesitant to branch into this area due to fear of non-compliance. Strict compliance is necessary for proper payor reimbursement and to avoid penalties.

I help medical providers structure telehealth offerings compliantly while ensuring a comprehensive understanding of all relevant rules and guidelines. A few considerations for successful telehealth offerings include:

• • Obtaining informed consent for remote visits
  • Verifying patient identities
  • Ensuring secure data transmission and storage
  • Maintaining accurate documentation for billing and clinical purposes
  • Establishing a provider-patient relationship under applicable laws, which may necessitate in-person follow-ups
  • Adhering to prescription regulations in the context of remote visits
  • Ensuring the clinical effectiveness of the telehealth model for a patient’s condition

I am very familiar with the legal framework surrounding telehealth offerings and can promote your practice’s compliance through tailored, individualized guidance.

No Surprises Act

The No Surprises Act protects patients against surprise medical bills, covering most emergency services and non-emergency services from out-of-network providers. This act impacts how you can legally bill clients and details procedures for providing notices and estimates in advance of appointments. Billing errors can lead to legal disputes and civil monetary penalties. 

I help medical providers understand how the No Surprises Act applies to their practices and conduct audits to identify potential areas of non-compliance. 

Cybersecurity Risk Mitigation

Your healthcare practice’s compliance extends to cybersecurity procedures to protect you against data breaches and cybercrimes. I can help you understand your legal obligations toward preventing cybercrimes through cybersecurity risk assessments and developing policies and procedures to safeguard data in your practice.  I can also guide you through patient notification and other critical steps in the event of a cybersecurity incident.

Medicare/Payor Audits

If you are facing a billing or coding audit by govenrment or commerical payors, I can provide legal guidance to navigate the process effectively. My services extend to responding to record requests, negotiating settlements, and helping you avoid future audits and penalties. 

Legal Guidance for Med Spa Compliance

Med spas are often targets for regulatory audits and legal scrutiny. In my experience, these businesses are often seriously underrepresented by legal counsel, placing them at significant risk of fines, licensure disciplinary actions, and reputational damage. I help both new and existing med spas understand and adhere to the complex regulatory framework governing these unique practices.