4. CMS begins surveying revised emergency preparedness standards. In September 2016, CMS finalized a rule issuing new emergency preparedness requirements for healthcare providers, including ASCs, participating in Medicare and Medicaid. The objective, according to CMS, was to increase patient safety during emergencies and establish a more coordinated response to disasters.
This final rule required Medicare and Medicaid participating providers and suppliers to meet the following four standards:
- Emergency plan: Based on a risk assessment, develop an emergency plan using an all-hazards approach focusing on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters specific to the location of a provider or supplier.
- Policies and procedures: Develop and implement policies and procedures based on the plan and risk assessment.
- Communication plan: Develop and maintain a communication plan that complies with both federal and state law. Patient care must be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency systems.
- Training and testing program: Develop and maintain training and testing programs, including initial and annual trainings, and conduct drills and exercises or participate in an actual incident that tests the plan.
Organizations affected by this rule were required to comply and implement all regulations by November 15, 2017. As of that date, CMS surveys began evaluating compliance based on these revised emergency preparedness standards.
5. Local and nationwide impact of multiple hurricanes. The effects of the three major hurricanes that hit the United States — Irma, Harvey and Maria — were felt well beyond the areas directly impacted by these disasters.
Considering the potential damage and likely business interruption caused by the storms, CMS granted exceptions for Medicare quality reporting requirements to ASCs located in these areas. (Note: CMS took a similar action for ASCs affected by the Northern California wildfires.)
Outside of these areas, the devastation brought by Hurricane Maria to Puerto Rico caused significant disruption in the production of common IV solutions. Puerto Rico produces more pharmaceuticals for the United States than any of the 50 U.S. states or any single foreign country. As an NPR report noted, the island is home to more than 100 drug and medical device manufacturers.
This includes Baxter, a major supplier of IV bags. The company reported that its facilities in Puerto Rico suffered some structural damage and power disruption, leading to multiple days of lost production. Facing an IV shortage, ASCs, like other healthcare providers, have been forced to more effectively manage their supplies, seek IV alternatives, and take other steps to ensure there is enough IV in stock to provide safe care to patients.
6. CMS cancels bundled payment initiatives. In a decision that would appear to slow the transition toward value-based care, CMS announced in late November that it was canceling two mandatory bundled-payment models and scaling back a third.
CMS finalized the cancellation of the mandatory hip fracture and cardiac bundled payment models and reduced the number of mandatory geographic areas participating in the Comprehensive Care for Joint Replacement model by about half.
7. Powdered glove ban takes effect. In December 2016, the U.S. Food and Drug Administration (FDA) finalized the banning of powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove. The FDA stated that its decision to finalize the ban was based on the "unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves."
As FDA noted, "The risks to both patients and healthcare providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications."
The ban became effective January 18, 2017.
What was particularly significant about this ban is that it represented only the second time the FDA has ever banned a medical device. The first was prosthetic hair fibers, banned in 1983.
Looking Ahead to 2018
2017 was a year full of activity for ASCs, and it is not unreasonable to expect the same for 2018. What will happen with OAS CAHPS? Is this the year when total joint replacement procedures are added to the ASC payable list? How will changes to the Affordable Care Act impact ASCs? Will CMS finally start updating ASC payments using the hospital market basket rather than the consumer price index for all urban consumers (CPI-U)?
Surgical Notes will be keeping a close eye on these and other developments to ensure we are prepared to respond quickly and effectively to any changes that could affect our clients and their ability to deliver high-quality, cost-effective care. For the latest company and industry news, visit www.surgicalnotes.com and follow Surgical Notes on LinkedIn.