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The Risks of Outsourcing Medical Billing and the Importance of State-Law Compliance

Client Alert

Offshoring medical billing and other administrative functions can reduce costs, but it also raises significant compliance, operational, and contractual risks. Although HIPAA does not explicitly prohibit protected health information from being accessed or stored outside the United States, healthcare providers and their vendors remain responsible for safeguarding patient information and complying with state-specific restrictions that may limit or prohibit offshore subcontracting. 

For healthcare organizations, outsourcing billing can create exposure far beyond routine vendor-management issues. If an offshore billing company mishandles protected health information, submits inaccurate claims, or fails to follow applicable payer requirements, the provider, not just the vendor, may face delayed reimbursement, audit scrutiny, breach-response costs, contractual disputes, and reputational harm. 

HIPAA considerations

HIPAA protects protected health information (PHI), including individually identifiable health information maintained or transmitted by covered entities and business associates. Vendors that create, receive, maintain, or transmit PHI on behalf of a covered entity generally qualify as business associates and must comply with HIPAA’s applicable privacy and security obligations. 

At a minimum, organizations should confirm that outsourcing arrangements address:

  • appropriate access controls and role-based permissions;
  • encryption and other reasonable safeguards for PHI;
  • workforce training and documented compliance policies;
  • a compliant Business Associate Agreement (BAA);
  • audit rights, monitoring, and recordkeeping; and
  • clear breach reporting and notification procedures.

State-law and program requirements

HIPAA is only part of the analysis. State Medicaid rules, managed care agreements, provider manuals, executive orders, and other state authorities may impose additional restrictions on offshore subcontracting. In some jurisdictions, these restrictions can require that certain services be performed in the United States or that patient data remain within the country. As a result, a provider may be compliant with HIPAA yet still violate contract or state-specific requirements. 

This risk is especially important because enforcing contractual and privacy obligations against an offshore vendor may be incredibly difficult. When a foreign subcontractor experiences a breach or other compliance failure, the healthcare provider often bears the immediate burden of investigation, remediation, patient notification, and regulator response. 

Practical takeaways

Before outsourcing billing or related administrative functions overseas, providers should:

  • review state statutes, administrative codes, Medicaid guidance, and managed care contract requirements that may apply to the services at issue;
  • confirm whether any payer or provider agreement restricts subcontracting or offshore access to PHI;
  • conduct diligence on the vendor’s technical, administrative, and legal safeguards;
  • negotiate a BAA and service agreement with audit rights, indemnification, reporting obligations, and clear data-security requirements; and
  • implement ongoing monitoring to verify compliance after the arrangement begins.

For questions regarding the individualized risk requirements or assistance with compliance and implementation, please contact Amanda Waesch at alwaesch@bmdllc.com


The DOL and EEOC Enter a Partnership to Strengthen Federal Employment Law Enforcement

On September 13, the U.S. Department of Labor’s (DOL) Wage and Hour Division and the Equal Employment Opportunity Commission (EEOC) entered into a Memorandum of Understanding (MOU) agreeing to work together in enforcing federal employment laws. The MOU forms a partnership between the two agencies to encourage coordination through information sharing, joint investigations, training, and outreach.

Proposed Laboratory Arrangement Draws Heightened Scrutiny from the OIG

On September 25, 2023, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO). The Opinion involved a proposed arrangement between an independent laboratory and other physician laboratories for the purchase of the technical component of anatomic pathology services. The OIG ultimately concluded that the arrangement at issue, if it was entered into with the requisite intent, would implicate the Federal Anti-Kickback Statute (AKS) and constitute grounds for sanctions.

SMALL BUSINESS ALERT: January 1, 2024 - Beneficial Ownership Information Reporting

Beginning on January 1, 2024, many small businesses across the United States will have to report personal information about their owners, beneficial owners, and others who own or exercise control over the company. The information will have to be reported to, and maintained by, the Financial Crimes Enforcement Network (“FinCEN”) as part of the Beneficial Ownership Information Rule. FinCEN is a bureau of the U.S. Department of the Treasury.

Health Care Inclusivity for the LGBTQIA+ Community

Healthcare providers, regardless of practice setting, should be aware of the healthcare disparities for LGBTQIA+ individuals, and ways in which they can be more inclusive of these individuals by making modifications to their practices.

Obtaining Patient Consent

Patients have autonomy to choose what can and cannot be done to their bodies. Therefore, informed consent is required before any treatments or procedures commence. This is a stark contrast to the previously recognized paternalistic approach, which relies solely on the decision-making of the provider. However, in order for patients to really choose whether or not to submit themselves to a particular healthcare service, they must actually understand what the service is. Therefore, patient consent should help the patient understand the risks and benefits, as well as any alternative treatment options.