FDA the Headache of Developing a Biosimilar Pathway
A recent article from MedPage Today explored a provision in the healthcare reform bill that called on the Food and Drug…
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Yearly Archives
2011
CMS Final Rule on Hospital Meaningful Use and Quality Reporting
The Centers for Medicare & Medicaid Services' final rule updating the hospital outpatient prospective payment system (OPPS)…
Institute of Medicine Report on Essential Benefits
The Patient Protection and Affordable Care Act of 2010 (ACA) was enacted to help uninsured Americans obtain health insurance. As…
CMS Turns Medicare Cuts into Bonus Payments Based on Patient Experience
The Affordable Care Act includes a number of policies to help physicians, hospitals, and other caregivers improve the safety and…
CMS-FDA Breast Cancer and Avastin: FDA Pulls Approval While CMS Pays
Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg announced in a 69-page decision that the agency would…
Healthy People 2020: The Twelve Greatest Health Care Gaps
Recently, federal health officials released a list of 12 "high priority" indicators of health, which the government will track…
Policy Updates and Enforcement Developments from FDA’s Medical Products…
A recent conference hosted by the Food and Drug Law Institute looked at the evolving role of technology, particularly in the realm…
Physician Payment Sunshine Act: CMS Proposed Rule – Impact on…
Last week’s proposed rule for the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act) had some troubling…
American Board of Medical Specialties to Create Maintenance of…
In the past several years, medical specialty boards have implemented maintenance-of-certification requirements to provide ongoing…
Physician Payment Sunshine Act: CMS Proposed Regulations — Public…
The Centers for Medicare and Medicaid Services (CMS) released the proposed regulations for the Physician Payment Sunshine…