FDA Releases New Guidance
On September 27, 2019, the Food and Drug Administration (FDA) released new guidance, replacing the December 2017 guidance, regarding clinical decision support (CDS) software. The new guidance expands the scope of the agency’s control of CDS software developed for providers, patients, and caregivers and clarifies which kind of software no longer is considered to be a medical device under the law. The guidance is a part of a series of guidance documents which signal the agency’s stance on and encouragement of health IT development. The new guidance clarifies the types of CDS software functions that would be subject to FDA oversight, categories that are exempt from regulatory requirements because they are low risk to patients, and categories that do not meet the definition of a medical device. For the complete guidance document, click here.
On September 17, 2019, a federal judge in the District of Columbia ruled in favor of the American Hospital Association and held that CMS exceeded its statutory authority when it reduced Medicare payments for hospital outpatient services provided in off-campus provider-based departments (“PBDs”) grandfathered under the Bipartisan Budget Act of 2015. American Hospital Association, et al. v. Alex Azar, II, et al, CA No. 18-2841. Despite the statutory exception created in the Bipartisan Budget Act, CMS promulgated a final rule which lowered the reimbursement rate for PBDs. Before the final rule, services provided at PBDs were reimbursed at the same rates as services provided on the main campuses of hospitals because the off-campus provider-based locations were subject to the same regulatory requirements and cost structures as hospitals. The court’s decision vacated the applicable portions of final rule and remanded the case to CMS for further action consistent with the correct legal standards. For the complete decision, click here.
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