“No Surprises Act” Regulations Raise Concerns

By Leigh Burchell (Allscripts), Chair, & Janet Campbell (Epic), Vice Chair,
EHRA Public Policy Leadership Workgroup

The growth in high deductible health plans requiring patients to shoulder more of their healthcare costs and the lack of transparency in healthcare pricing has exacerbated the issue of patients left with surprise medical bills that many cannot afford to pay. The urgent need to address these serious issues is why the EHRA supported the No Surprises Act when it was developed and welcomed the regulations published last year as a foundation upon which it can be implemented. 

However, we have several concerns about rulemaking to date as it relates to workability and the unnecessary burden it creates for industry stakeholders. To that end, we reached out proactively to regulatory agencies to provide feedback in four key areas that we believe – based on our member companies’ experiences and our ongoing advocacy for reasonable timelines and requirements – will be informative when it comes to additional regulatory actions expected later this year. 

However, we have several concerns about rulemaking to date as it relates to workability and the unnecessary burden it creates for industry stakeholders.

Health IT Intersections
While we strongly support the intent behind the No Surprises Act, the timeline for rollout is unreasonable as its framework depends on a healthcare-wide infrastructure that simply does not yet exist. In particular, the expectations for convening providers to gather extensive data from co-providers or co-facilities are unrealistic – exacerbated by the fact that it is not always clear days in advance of the procedure exactly who will be involved. Additionally, the lack of a standardized approach to sharing required information with payers adds complexity and creates an unnecessary burden for all involved parties. 

Looking ahead to the Good Faith Estimates (GFE) requirements, the burden on health IT developers and providers becomes increasingly apparent. The anticipated timeline is insufficient for developers to make necessary updates and deploy new functionality or for healthcare organizations to train their staff on changes and master adjusted workflows. 

Even where some requirements may possibly be met without health IT, automation is certainly preferred as much as possible. However, the absence of an explicit requirement for technology associated with this regulation raises concerns that we’ll be asked to support workflow, data exchange, and reporting changes without sufficient time to do so. It’s critical that regulators include necessary interoperability standards/implementation guidance to enable the collation of relevant data across the different health IT in use by providers in a way that does not increase the documentation burden.

Impact on Workflow & Non-IT Resource Needs

The requirement to produce GFEs for uninsured and self-pay individuals as already in effect has led to additional work for staff at provider facilities, including manual data entry into the CMS-recommended GFE form, additional calls to patients to verify that insurance will be used, and the hiring of additional staff at larger institutions. The GFE, while helpful for uninsured patients, is an entirely new process for many healthcare facilities, and the requirement had an unreasonably short turnaround time. 

There are also numerous scenarios raised by providers that appear to be unaddressed or insufficiently considered in the regulations released to date, most of which will be significantly amplified when GFEs are required for all patients:

  • patients who do not fully understand their insurance coverage or make last-minute decisions to self-pay (even when they have insurance), creating implications related to GFE requirements on the day of the visit
  • care environments that don’t bill  patients because care is covered by a monthly fee (e.g., Direct Primary Care practices)
  • lack of guidance on what the GFE should include when little or no clinical history exists to inform the provider
  • the anticipated burden created for provider organization staff to verify and codify the accuracy of what is included in each GFE

Updates to HIPAA Standards & Code Sets
The billing and estimate provisions of the No Surprise Act that took effect on January 1, 2022, could efficiently be satisfied through updates to HIPAA administrative standards and code sets, which can easily be used to communicate routine information. However, this can happen only when there is an understanding between the plan/issuer and provider/facility as to what the fields and codes mean. To our knowledge, there has been no effort to update those standards to support the automation of these requirements. 

Convening Provider Requirements
CMS has indicated that on January 1, 2023, it will begin enforcing a requirement for the convening provider or facility to generate a GFE for its own expected items and/or services, as well as to coordinate receipt of GFEs from co-providers and co-facilities for compilation into one comprehensive GFE for the patient. While some organizations may be able to comply when services will be furnished solely by their own practitioners and facilities, it is far more complicated to do so when multiple parties are involved, particularly in such a short time frame without the necessary industry-wide infrastructure. 

Ideally, the efforts for price transparency and GFEs lead to the interoperable exchange of discrete data elements related to fee schedule amounts; however, there are no processes within the existing HIPAA code sets that focus on the request and receipt of expected charges prior to the delivery of services. Essentially, this requirement completely changes the workflow associated with charge analysis and submission, making this an issue much broader than just technical. This requires time to address; it isn’t a change that can happen overnight. 

Requests & Recommendations
We asked CMS to consider four requests that would allow health IT developers and healthcare providers to comply with the No Surprise Act:

  1. Refrain from issuing regulations that establish a date by which providers must provide GFEs and/or Advanced Explanation of Benefits (AEOB) to insured patients until the necessary industry infrastructure can be completed. 
  2. Collaborate with standards development organizations to speed the availability of consensus-based standards helpful to the exchange of the relevant data for price transparency; future rulemaking should include a requirement that all stakeholders employ technology inclusive of the new standards.
  3. Formally announce a lenient policy for enforcement of the provisions already in effect to the extent that only blatant disregard for the Act’s intentions is penalized. 
  4. Work with the Office of Civil Rights (OCR) to issue its rulemaking on electronic claims attachments. 

The full letter is available here

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