Understanding the Regulatory Burden across the Healthcare Spectrum

April 1, 2021
April 1, 2021

The regulatory burden faced by organizations across the healthcare continuum is significant in terms of the time and resources involved in meeting requirements. This was made especially clear during a recent webinar, Challenge the Status Quo: Ending the Regulation Training Hunt, from HCCS, A HealthStream Company, that was led by Ben Diamond, Vice President of Compliance Solutions, and Debbie Newsholme, Senior Director of Content Development and Compliance Solutions.

Diamond and Newsholme began the webinar with some statistics about the regulatory burden:

  • $39 billion – the annual cost to healthcare providers to comply with the administrative aspects of regulatory compliance
  • 629 total discreet regulatory requirements – (341 hospital-related requirements and 288 post-acute care-related requirements)
  • 59 full time equivalents (FTEs) – the number of staff an average-sized hospital must dedicate to regulatory compliance
  • Multiple domains with different compliance ramifications: quality reporting, meaningful use of EHRs, hospital conditions of participation, fraud and abuse, privacy and security, post-acute care billing and coverage verification requirements, etc.

Newsholme spent a significant amount of time focusing on the expanded scrutiny that federal and state governments are placing on the areas of the healthcare continuum that are outside the hospital. She believes this will be an expanded focus and become more intense as time goes by. Some examples include:

Home Health

Newsholme offers that the government now audits a targeted number of claims to establish a benchmark for individual home health organizations. If they identify a high level of claims that are not accurate, then they're going to provide one-on-one education to the provider. According to Newsholme, “It's becoming more and more important that organizations not only have training about their billing processes, but also about what constitutes fraud, and what that looks like from a regulatory perspective.”


One of the usual suspects for scrutiny in the hospice environment is eligibility. Typically, regulators are going to ask if a person meet the eligibility to be considered for hospice care. That answer should determine the different levels of care, from general inpatient continuous care to home hospice or respite care. Newsholme singles out long lengths of stays as a red flag and mentioned an example where “patients were admitted to hospice and were still there after a year's time.” That obviously does not meet the criteria for hospice and is likely to draw the scrutiny of the OIG and other governmental agencies.

Nursing Homes, Skilled Nursing Facilities, and Adult Living Facilities

These organizations are drawing scrutiny for quality of care, especially for such purposes as rehabilitation and whether patients are getting the types of care that satisfies the quality measures that they need and deserve. According to Newsholme, there’s increased likelihood for corporate integrity agreements related to skilled nursing facilities that are not meeting even minimum quality of care standards. She added, “In some cases, they were deemed to be providing worthless or unnecessary care. That's an area of very close scrutiny, and actions are being taken against some of these agencies.” Another focus is the medical necessity for therapy and whether a patient meets the criteria for receiving it, whether it is physical therapy, rehab therapy, or even occupational therapy.

Staffing Records and Ratios

Newsholme offers that the OIG has placed a general focus on whether a caregiver has the qualifications and the competencies to be providing the care that they are providing. In other words, if there's a licensure or scope of practice indicator, do the individuals who are providing it meet those criteria? Also, staffing ratios—the number of patients to staff—themselves are very important. In assisted living facilities, the focus is on the quality of care. According to Newsholme, “from the corporate integrity agreement (CIA) perspective, we've seen more and more quality CIAs over the last several years.” Where it used to be more in the terms of fraud, abuse, contracts and arrangements, anti-kickback or stark violations, or illegal transactions, now there's just as many quality of care issues that are being investigated.

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