Biden Administration Rescinds Trump Administration Insulin …
WEBOct 26, 2021 · One of the final healthcare actions made by the Trump Administration has been rescinded by the Biden Administration. On December 23, 2020, the Trump Administration finalized a rule that directed the Department of Health and Human Services (HHS) to take action to require that federally qualified health centers (FQHCs) make insulin and injectable epinephrine available to certain patients at 340B ...
Institute of Medicine Report – The Future of Nursing: Leading …
WEBFeb 17, 2011 · As the current debate surrounding the Affordable Care Act (ACA) continues in Congress, a number of strengths and weaknesses of the legislation are being emphasized. One specific issue is how the American …
The Supreme Court and “Pay for Delay:” The Potential Impact on …
WEBJan 15, 2013 · Other “Pay for Delay” Cases Although the 11 th Circuit upheld the reverse payment agreement, the U.S. 3rd Circuit Court of Appeals in Philadelphia took the opposite view in a case involving K-Dur, a drug used to treat a potassium deficiency. The court ruled in July 2012 that “drug-patent settlements are legally suspect unless the drug makers involved can show that such agreements are ...
Developing Fair Market Value for Physician Payments
WEBDec 8, 2011 · Cutting Edge Information is a widely recognized leader in providing fair-market value (FMV) consulting to help life sciences companies develop their physician fee schedules. CEI performs custom, client-driven studies using proprietary databases and research methodologies. Cutting Edge Information’s data …
CMS Issues New Guidance on Independent Dispute Resolution …
WEBJun 6, 2022 · By Thomas Sullivan Last updated May 30, 2022. On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process, created under the No Surprises Act (NSA) to provide a mechanism for payers and providers to resolve disputes as to appropriate payment amounts for certain ...
CMS Issues Final Rule on Managing Conflicts of Interests in …
WEBFeb 12, 2015 · In March 2013, the Department of Health and Human Services Office of Inspector General released a report entitled Gaps in Oversight of Conflicts Of Interest in Medicare Prescription Drug Decisions. In that document, OIG was critical of the Center for Medicare and Medicaid Services’ (CMS) lack of oversight of Medicare Part D drug plan pharmacy and therapeutics (P&T) committee conflicts of ...
FDA Guidance on Adaptive Clinical Trials Design - Policy & Medicine
WEBDec 19, 2019 · The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer ...
ACCME’s Conflict of Interest Procedures – Policy & Medicine
WEBApr 9, 2014 · At last week’s American College of Cardiology annual meeting In Washington D.C., Murray Kopelow, President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), spoke to the ACCME’s conflict of interest (COI) requirements. His presentation was part of a larger COI session entitled “Let the Sunshine in: Research and Education in an Era of the 24-Hour News Cycle.”
FDA Guidance for Industry on Medication Guides
WEBMar 15, 2011 · The Food and Drug Administration (FDA) recently published Guidance for Industry on Medication Guides, entitled “Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).”. The guidance is intended to address two topics pertaining to Medication Guides for drug and biological products:
Modern Medicine vs. Alternative Medicine: Different Levels of …
WEBAug 16, 2011 · Alternative Medicine vs. Modern Medicine. About 40 percent of Americans have tried some form of alternative medicine at some point, and some $35 billion a year is spent on it. A certain amount of abuse seems like a given. Nonetheless, says Salzberg, the bottom line is that studies clearly show alternative medicine simply does not work.