Health Headlines: Also in the News - December 2014

CMS Extends Comment Period for Home Health Conditions of Participation Proposed Rule – As previously reported, on October 9, 2014, CMS published in the Federal Register a Proposed Rule that would revise the home health Conditions of Participation (CoPs). Comments on the Proposed Rule were initially due by December 8, 2014. However, in a notice published by CMS in the Federal Register on December 1, 2014, CMS has extended the comment period for 30 days. Comments are now due by January 7, 2015. The CMS notice is available here.

CMS Extends Deadline for 2014 Meaningful Use Attestations – CMS announced on November 24, 2014, that it is extending the deadline for eligible hospitals and Critical Access Hospitals (CAHs) to attest to meaningful use for the Medicare Electronic Health Record (EHR) Incentive Program 2014 reporting year. The new attestation deadline is 11:59 p.m. Eastern Time on December 31, 2014; the prior deadline was November 30, 2014. The extension does not affect submission deadlines for the Medicaid EHR Incentive Program. A copy of CMS’s announcement is available by clicking here.

Senate Passes Short-Term Delay of Outpatient Supervision Requirements for Critical Access and Small Rural Hospitals – On November 20, 2014, the Senate passed H.R. 4067, a bill to delay enforcement, through the end of 2014, of the requirement for direct supervision by physicians for outpatient therapeutic services furnished at Critical Access Hospitals (CAHs) and small rural hospitals with 100 or fewer beds. The bill, which was already passed by the House in September, was presented to the President for approval on November 25, 2014. A copy of H.R. 4067 is available by clicking here.

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research Under 21 C.F.R. § 50.24 – On November 17, 2014, the U.S. Food and Drug Administration published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the requirement to obtain informed consent from research subjects for emergency research. This exception from informed consent for the use of investigational drugs in emergency research could be sought for public health situations where potential research subjects are incapacitated, in a life-threatening clinical situation, and unable to immediately give consent (e.g., community outbreaks of Ebola virus infection). King & Spalding’s Client Alert providing a more detailed discussion of the manual update is available by clicking here.