The Centers for Medicare & Medicaid Services aims to reduce unnecessary burdens for healthcare providers with the introduction of the Omnibus Burden Reduction (Conditions of Participation) Final Rule.

The regulation falls in line with Patients over Paperwork, an initiative developed under the Trump administration that calls for agencies to “cut the red tape” of burdensome regulations that clinicians face. The final rule is expected to do this by eliminating regulations and minimizing administrative healthcare costs to the point where providers are projected to save approximately $8 billion in administrative costs over the next decade and an estimated 4.4 million hours previously spent on paperwork annually.

“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,” said CMS administrator Seema Verma in a statement. “This final rule brings a common sense approach to reducing regulations and gives providers more time to care for their patients, while reducing administrative costs and improving health outcomes.”

The omnibus final rule takes into account the thoughts of various stakeholders — patients, clinicians and other providers — on burdens they face, and aims to help do away with them by improving patient care, eliminating burdensome rules, and eliminating duplicative regulations.

Under the new rule, CMS plans to improve patient care for kidney transplants by increasing the number of available organs and decreasing the number discarded. This involves finalizing changes to transplant center requirements, specifically those around data submission, to offer providers greater freedom and flexibility to support patients in need of organ transplants.

The rule also will do away with regulations it considers burdensome and obsolete to enable multiple hospitals within a system to employ unified quality assessment and performance improvement programs. This will allow providers to implement best practices and innovations across facilities for quicker improvements in the quality of care, and will enable small and rural hospitals to draw from the resources and clinical expertise of a larger hospital system.

CMS also plans to reduce certain required activities that create these rules. For instance, previous protocols demanded that X-rays be written and signed, while the new regulations will be for these orders to be transmitted in written form, by telephone or electronically. In addition, timeline revisions for requirements will be implemented to increase the time that providers can spend directly with patients, and the frequency of mandated policy reviews and program evaluations for rural clinics and federally qualified health centers will be pushed back from once a year to every two years.

Another burden eliminated is duplicative requirements, such as the reduction of emergency preparedness regulations across care settings, which are required to review such plans each year. Exempt from this are long-term care facilities like nursing homes, which require annual emergency preparedness plans to be reviewed for patient and resident safety.

It should be noted that for the purpose of tracking savings under the Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs”, that the savings calculated is a 2016 estimate and discounted at seven percent relative to 2016 for easy comparison across all regulatory activities pursuant to the Executive Order. This does away with the impact of inflation of CMS' estimates, leading to an annual savings of $647 million in perpetuity for purposes of the Executive Order.

CMS is currently finalizing changes that improve regulations around patient safety and quality of care. It will continue seeking stakeholder input.

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