CMS is trying to reduce the burden of unnecessary bureaucratic requirements, including some types of data collection and analysis. The new rule could help healthcare systems save time and money around data collection, with less need for duplicated work from nonacute care ancillary organizations.1

The Omnibus Burden Reduction (Conditions of Participation) Final Rule “strengthens patient safety by removing unnecessary, obsolete, or excessively burdensome health regulations on hospitals and other healthcare providers,” according to a description by CMS.2 The rule is part of the agency’s Patients over Paperwork initiative. CMS estimates the change could save providers 4.4 million hours previously spent on paperwork annually. Further, over the next decade, CMS projects the rule could lead to total provider savings of about $8 billion.

“In my trips across the country, I’ve heard time and again that unnecessary regulations are increasing costs on providers and they are losing time with patients as a result,” CMS Administrator Seema Verma said in a statement.2 “This final rule brings a commonsense approach to reducing regulations and gives providers more time to care for their patients, while reducing administrative costs and improving health outcomes.”

Changes in Data Collection

The new rule could lead to changes in process and how data are collected, says David Williams, general manager of the healthcare provider business unit at Conduent, a process services company based in Florham Park, NJ. Those changes will result in cost reduction to the patient and to the healthcare organizations, he says.

“The rule will help healthcare systems save time and money in the efforts around data collection, with less need for duplicated work from nonacute care ancillary organizations such as ambulatory centers, nursing homes, and home health,” he says.

The effect will vary from one organization to another, he says. No one institution will see the same immediate results. It takes time to track and trend the data to truly see an effect.

“Limiting the number of hurdles and red tape prior to treatment can certainly lead to better patient outcomes and improved patient satisfaction,” Williams says. “Patient safety encompasses much more than this final rule. It’s important for healthcare organizations to still promote a culture of safety.”

Easing QAPI Requirements

One change involves existing regulations that require each Medicare-certified hospital to develop and maintain ongoing Quality Assessment and Performance Improvement (QAPI) programs and infection control programs. Under the new rule, multiple hospitals within a system may employ a unified QAPI program.

“This change makes it easier for hospitals to implement best practices and innovations among facilities resulting in quicker improvements in quality of care,” CMS says.2 “This also benefits small and rural hospitals by allowing them to draw from the resources and clinical expertise of a larger hospital system.”

Another change is intended to strengthen the organ donation process. The rule finalizes changes to transplant center requirements giving providers greater flexibility and freedom to support patients who need organ transplants. Overly burdensome requirements regarding data submission had discouraged some organizations from performing kidney transplants. The rule will eliminate these requirements.

CMS provides other examples of changes under the new rule:

• Reducing required activities. Instead of requiring written and signed orders for X-rays, the rule allows the orders to be transmitted by phone or electronically.

CMS also is reducing the frequency of policy reviews and program evaluations. Federally qualified health centers and rural health clinics can reduce the reviews from annually to once every two years.

• Eliminating duplicative requirements. CMS is changing the requirements on emergency preparedness to flexibility regarding the review of emergency preparedness plans, which currently must be reviewed annually.

The rule may effectively reduce some of the burden of data collection and tracking that healthcare organizations face now, Williams says, but it still will be important to ensure that technology is safe and used to improve patient safety. Tracking and trending of data still will be needed.

“However, this rule will give organizations the option to collect data that are relevant to their processes and not just to meet government regulations,” Williams says. “Streamlining the quality metrics collected within the healthcare system will give a unified snapshot of how the system is performing as a whole.”

With this final rule, the goal is to strengthen patient safety by removing the barriers with health regulations on hospitals and healthcare providers, allowing providers to put the focus back on the patient, Williams says.

Quality professionals should expect continuous re-evaluation of current processes, changes to those processes, and creating a common set of safety metrics that reflect meaningful outcomes, he says. The goal should be creating a coordinated oversight of patient well-being that addresses safety across the entire care continuum, he says.

“Culture and leadership are key in driving change. By all means, leaders should evaluate the current processes and develop coherent strategies to address any new processes that may be affected from this final rule, especially if it reduces the burden on healthcare professionals and allows them to focus on patient care.”


  1. Centers for Medicare & Medicaid Services. The Omnibus Burden Reduction (Conditions of Participation) Final Rule. Federal Register, Sept. 30, 2019. Available at:
  2. Centers for Medicare & Medicaid Services. Trump administration puts patients over paperwork by reducing healthcare administrative costs, Sept. 26, 2019. Available at: