On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
OIG Issues Advisory Opinion Allowing Hospice to Provide Free “Community Services”
The hospice said that the services to be provided would include things like companionship, transportation, running errands, food preparation, and providing respite for caregivers, and they would be provided by unpaid volunteers. This “community services” program would not be actively marketed to the community, and the services would be available only to individuals who reside in their home, and not those in skilled nursing facilities. The hospice would employ a volunteer coordinator to oversee the volunteers and communicate with those receiving the services, but the expenses would be kept separate and would not be included on the hospice’s, or its parent hospital’s, cost report.
The factors identified by the OIG as protecting against fraud and abuse included: (1) that the hospice will not actively market the program in the community, but will educate hospital case managers and physician offices about its availability for eligible patients, and will provide individuals who opt to receive the services with information about their right to choose a provider of home health or hospice services, and a list of known providers in the patient’s service area; (2) the arrangement is unlikely to increase federal health care program costs because the services would be provided by volunteers and the costs associated with the program would be segregated, and (3) the eligibility criteria for receiving hospice care, and the relatively small monetary value of the services act as a safeguard against the risk of overutilization that is often associated with the inducement provided by free services.
This Advisory Opinion is similar to one issued to the Hospice of Martin & St. Lucie in 2000 regarding a program to provide volunteer services to individuals in their homes and in nursing homes.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017