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Healthcare Law

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FDA Releases New Guidance

October 7, 2019

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.

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.

We send these Alerts to our clients and friends to share our insights on new developments in the law. Nothing in this Update should be relied upon as legal advice in any particular matter. © 2019 Riker Danzig Scherer Hyland & Perretti LLP.

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