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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


Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.

S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio

Just before the end of calendar year 2020 and at the end of its two-year legislative session, the Ohio General Assembly passed Senate Bill 263, which prohibits insurance companies and pharmacy benefit managers (“PBMs”) from imposing on 340B Covered Entities discriminatory pricing and other contract terms. This is a win for safety net providers and the people they serve, as 340B savings are crucial to their ability to provide high quality, affordable programs and services to patients.

DOL Finalizes New Rule Regarding Independent Contractor Status, But Its Future Is In Jeopardy

On January 6, 2021, the Department of Labor announced its final rule regarding independent contractor status under the Fair Labor Standards Act. As described in a prior BMD client alert, this new rule was fast-tracked by the Trump administration after its proposal in September 2020. The new rule is set to take effect on March 8, 2021, and contains several key developments related to the "economic reality" test used to determine whether an individual is an independent contractor or an employee under the FLSA.