Potential Paths Forward for Lessening the Healthcare Regulatory Burden

April 1, 2021
April 1, 2021

This blog post is the second of three excerpts from our recent article, “Easing the Burden: Healthcare Providers Are Crying Out for Regulatory Relief. Is the Government Listening?”

Additional costs buried in regulatory oversight include quality reporting, which has been shown to be a costly (per the report, $709,000 a year on administrative aspects) process, thanks to duplication and misalignment in requirement, “many of which require manual data extraction, create inefficiencies and consume significant financial resources and clinical staff time.”

Those issues are joined by fraud and abuse laws such as the Stark Law and the Anti-Kickback Statute, which the report called impediments to transforming care delivery: “While CMS has waived certain fraud and abuse laws for providers participating in various demonstration projects, those who receive a waiver generally cannot apply it beyond the specific demonstration or model. The lack of protections extending care innovations to other Medicare patients or Medicaid and commercially-insured beneficiaries minimizes efficiencies and cost savings realized through these types of models and demonstration projects,” the report states.

Making Regulatory Requirements More Effective

The layout out of these facts and figures is a grim exercise, and the AHA takes care to point out that there are remedies to make regulatory requirements more effective, including but not limited to:

  • Better alignment and consistent application within and across federal agencies and programs
  • Routine review for effectiveness to ensure the benefits for the public good outweigh additional compliance burden
  • The provision of clear, concise guidance and reasonable timelines for the implementation of new rules
  • Conditions of Participations should be evidence-based, aligned with other laws and industry standards, and flexible in order to support different patient populations and communities
  • Agency acceleration of the transition to automation of administrative transactions, such as prior authorization
  • Streamline Meaningful Use requirements to focus more on interoperability, without holding providers responsible for the actions of others

Recommended Solutions from the AHA

The AHA’s recommended solutions, as far as the above items go, are wide in scope and fairly ambitious, as far as what the government should do. Here’s a sampling:

  • Suspend the faulty hospital star ratings from the Hospital Compare website
  • Cancel Stage 3 of Meaningful Use of electronic medical records
  • Suspend all regulatory requirements that mandate submission of electronic clinical quality measures
  • Rescind the long-term care hospital 25% rule and instead rely on the site-neutral payment policy to bring transformative change to the field
  • Restore compliant codes that count to the inpatient rehabilitation facility 60% rule
  • Modify Medicare conditions of participation to allow hospitals to recommend post-acute care providers

It’s hard to say whether, or when, federal agencies (or their counterparts at the state and local levels) will engage with the AHA’s recommendations. Many Obama-era regulations in other areas are being reduced or repealed by the Trump administration, however, and that has given healthcare industry watchers much to talk and prognosticate about. Like seemingly everything else in healthcare, those opinions vary across the ideological spectrum and often bring in other complex issues such as single-payer healthcare.

Acknowledging the Impact on Outcomes

For instance, Physicians For A National Health Program’s Dr. Don McCanne posited that “A quick look at the nine domains of regulatory overload is all you need to be reminded of the nightmare created by these evolving requirements. Inefficiencies, wasted resources, and provider burnout ensue, which negatively impact the primary mission of the health care system: patient care.” He then goes on to make the case for single payer while also saying that regulatory oversight is still essential. “We desperately need reform, but let’s get it right,” he concluded. (McCanne, 2017).

Interaction with Pay for Performance Models

Elsewhere, Cerner’s Senior Director of Public Policy Meg Marshall took a look at governmental efforts, from late actions by the Obama administration to the Trump team’s attempts at Affordable Care Act repeal and subsequent congressional changes such as eliminating a mandated penalty for not purchasing coverage, as things to watch alongside regulatory change and repeal for beleaguered health systems and providers. On the IT front, for instance, the Cures Act, signed into law in late 2016, provided $10.5 billion to assist providers using electronic health records increase their interoperability. There is related legislation, most notably the Trusted Exchange Framework and Common Agreement, but outcomes overall remain murky due to their relative newness and the voluntary nature of participation in some instances. (Marshall, 2018). Marshall also called out evolutions in payment that will cement a “pay for performance” model for healthcare going forward, rather than the historical bent toward fee-based billing. That also is likely to affect regulatory performance when it comes to privacy oversight and related records handling.

“The days of generating fees-for-service to increase revenue are over,” Marshall says. “With the digitization of electronic health care data, we’re going to continue seeing innovations. That’s going to create some interesting challenges. Data access rights, privacy, and other related policy needs to be addressed to bridge data and business models from non-health care industries. Each industry has grown up with its own expectations around data access, use and agreements. We will probably see some significant changes happen to HIPAA, for example, to accommodate what we need in the health care space.” (Marshall, 2018).

Future Installments of this series will cover:

  • CMS Responds with Rule Changes and Request for Input
  • One Way, Many Ways, or Any Way Forward?


McCanne, D., MD. (2017, October 27). “The cost of regulatory overload.” Retrieved August, 2018, from http://pnhp.org/blog/2017/10/27/the-cost-of-regulatory-overload/

Marshall, M. (2018, February 7). “How Health Care’s Regulatory Landscape is Shifting in 2018.” Retrieved August, 2018, from https://www.cerner.com/blog/how-health-cares-regulatory-landscape-is-shifting-in-2018