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
Implementing Health Care Reform Community-Based Care Options
The Department of Health and Human Services (HHS) released new rules to implement two community-based care options under Medicaid created by the Patient Protection and Affordable Care Act (PPACA):
- A final rule implementing the Community First Choice program, a new State plan option for providing home and community-based attendant services and supports to Medicaid beneficiaries with disabilities. Under the final rule, States electing to participate in the option will receive a six-percentage point increase in federal matching funds for providing community-based attendant services and supports to beneficiaries who would otherwise be institutionalized. The final rule is available here.
- A proposed rule to revise Medicaid regulations to define and describe State plan home and community-based services (HCBS). The rule provides States new flexibility in providing HCBS services to elderly and disabled populations and eliminates the eligibility link between HCBS and institutional care that exists under the Medicaid HCBS waiver program. A separate correction notice clarified that the comment period for this rule is 60 days instead of 30 days, meaning comments are due by July 2, 2012.
Also on April 26, 2012, HHS announced the first 16 participants in the Independence at Home Demonstration program—a program established by PPACA to encourage primary care practices to provide home-based care to chronically ill Medicare patients. The participants will test whether delivering primary care services in the home can improve the quality of care and reduce costs for patients living with chronic illness. The demonstration is scheduled to run from June 1, 2012, through May 31, 2015.
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