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On September 26, the Centers for Medicare & Medicaid Services (CMS) issues a final rule on The Omnibus Burden Reduction (Conditions of Participation) Final Rule. The intent of the rule is to strengthen patient safety by removing unnecessary, obsolete, or excessively burdensome health regulations on hospitals and other healthcare providers. The rule seeks to advance CMS’s Patients over Paperwork initiative by saving providers an estimated 4.4 million hours previously spent on paperwork annually, with overall total provider savings projected to be approximately $8 billion over the next 10 years, giving doctors more time to spend with their patients.

CMS conducted a comprehensive review of regulations to determine where changes to obsolete, duplicative, or unnecessary requirements could be made to improve healthcare delivery. The agency is finalizing changes that streamline and improve regulations to provide greater focus on patient safety and improve quality of care. CMS performed this work from three perspectives: improving patient care, eliminating burdensome rules, and eliminating duplicative regulations.

The rule finalizes changes to transplant center requirements, giving providers greater flexibility and freedom to support patients who need organ transplants. Current Medicare transplant center regulations for re-approval are burdensome. They are so burdensome, in fact, that they have led to some transplant programs avoiding performing transplants for certain patients, causing some organs to be discarded. The Omnibus rule will eliminate these requirements – specifically for data submission – which will reduce the number of organs that are discarded and increase the number of organs that are available for transplantation. As a result, more patients on the transplant waiting list will have access to life-saving organ transplants.

Additionally, under existing regulations, each Medicare-certified hospital is required to develop and maintain ongoing Quality Assessment and Performance Improvement (QAPI) programs and infection control programs. The final rule will streamline the regulations to allow multiple hospitals within a system to 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. This also benefits small and rural hospitals by allowing them to draw from the resources and clinical expertise of a larger hospital system.

The final rule also focuses on eliminating burdensome rules by reducing certain required activities. For example, under previous rules, orders for X-rays were required to be written and signed. Under the new regulation, such orders may be transmitted in written form, by telephone, or electronically. In addition, by revising timelines for some requirements, providers will now have more time to spend on direct patient care. Specifically, CMS is reducing the frequency of policy reviews and program evaluations that rural health clinics and federally qualified health centers are required to conduct from annually to once every two years.

Finally, CMS focused on eliminating duplicative requirements, while carefully considering patient safety. An example of this is flexibility with respect to emergency preparedness. Under current rules, providers across care settings are required to review their emergency preparedness plans annually. The proposed rule reduced emergency preparedness requirements across care settings, including long-term care facilities such as nursing homes. However, through the comment process, CMS heard concerns that this annual requirement is necessary for patient and resident safety in the nursing home setting, so this proposal was not finalized for long-term care facilities.

The Omnibus final rule is the result of extensive work that included gathering feedback from various stakeholders, including patients, clinicians and other providers. CMS held 102 listening sessions in 46 states and two territories, with representatives from the clinician community, hospice, home health, and across the spectrum of providers. Additionally, CMS issued two Requests for Information (RFIs) to better understand where providers were experiencing the most burden. The first RFI, released across nine proposed rules in 2017, yielded 3,040 mentions of burden, which CMS categorized as related to 1,146 different issues. CMS analyzed all input and has taken action on, or is actively considering, 83 percent of the burden topics raised that are actionable by CMS. Some of the remainder were referred to other federal agencies for action. Others have not been acted upon for various reasons, including those deemed to be statutorily prohibited. The second follow-up RFI was released in 2019 to gather new ideas not conveyed during the first RFI, as well as innovative ideas that may help broaden perspectives about potential solutions.

The Omnibus final rule is expected to achieve approximately $800 million in savings annually through the year 2028, or approximately $8 billion over the next 10 years. For purposes of tracking savings under Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” the savings number is calculated in 2016 dollars and discounted at 7 percent relative to 2016 to ensure ease of comparison across all regulatory activities pursuant to the Executive Order. This alternative calculation essentially eliminates the effect of inflation in CMS’s estimates, resulting in $647 million in annual savings in perpetuity for purposes of the Executive Order.

Read the Final Rule here