Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Chelsea Rutherford ordered by Published Date Descending.
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New York AG Settlement With App Developers Serves As A Warning For The Need For Evidence-Backed Commercial Claims
On March 23, 2017, the New York Attorney General's office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims.
United States
12 Apr 2017
HHS Finalizes Toned - Down Version Of Common Rule Overhaul
All stakeholders involved in federally funded research should be aware of the Final Rule's changes and prepare to implement them.
United States
22 Feb 2017
Modernizing Public And Private Research
Through National Institutes of Health (NIH) funding mechanisms, the 21st Century Cares Act prioritizes certain areas of medical innovation—namely cancer care, regenerative therapies, neurotechnologies and precision medicine—and will likely steer both public and private funding priorities in those directions for years to come.
United States
6 Feb 2017
HHS Finalizes Overhaul Of Federal Human Subjects Research Protections
On January 18, 2017, the Department of HHS and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the "Common Rule."
United States
24 Jan 2017
OMB Reviewing Common Rule Overhaul
On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB).
United States
12 Jan 2017
First 60 Day Rule Overpayment Case Ends With Almost $3 Million Settlement
As part of a settlement agreement reached on August 23, three hospitals and their former parent system agreed to pay $2.95 million to resolve state and federal False Claims Act (FCA) allegations...
United States
9 Sep 2016
CMS Proposes CY 2017 Home Health PPS Rate, Updates To Value-Based Purchasing Model And Quality Reporting
The Centers for Medicare & Medicaid Services (CMS) recently released proposed updates to its CY 2017 Home Health Prospective Payment System
United States
4 Aug 2016
OIG Continues To Refine Guidance On Patient Assistance Programs
Historically, the OIG has treated PAPs as important safety nets for patients who face chronic illnesses and high drug costs.
United States
24 Feb 2016
"Operation Spinal Cap" Sees Former Hospital Executive, Physicians Charged For Their Roles In Kickback Scheme
The schemes implicated dozens of surgeons, orthopedic specialists, chiropractors, marketers, and other medical professionals.
United States
4 Dec 2015
CMS Finalizes Controversial Changes To "2-Midnight Rule" For Inpatient Stays
On October 30, 2015, the Centers for Medicare & Medicaid Services released its final rule updating the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for Calendar Year 2016.
United States
10 Nov 2015
Recent Advisory Opinion Shows OIG's Growing Acceptance Of Financial Integration Among Related Entities
On July 20, the Office of Inspector General of the Department of Health and Human Services posted a new Advisory Opinion addressing a health system's restructured arrangement to lease employees.
United States
23 Sep 2015
HHS Releases Highly Anticipated Proposal To Modernize U.S. Human Subjects Research Protections
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections...
United States
13 Sep 2015
White House Releases Draft Privacy Principles For The Precision Medicine Initiative
The Initiative is a research effort launched by President Obama in the 2015 State of the Union address.
United States
31 Jul 2015
CMS Proposes Value-Based Purchasing Model, Other Updates To The 2016 Home Health Prospective Payment System
The U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services published its proposed update to the home health prospective payment system for calendar year 2016 in the July 10, 2015 Federal Register.
United States
20 Jul 2015
CMS Proposal Broadens Medicare Inpatient Reimbursement Eligibility Under The "2-Midnight Rule"
Originally, CMS developed the 2-Midnight Rule as a framework to determine when payment under Medicare Part A was appropriate for inpatient stays.
United States
8 Jul 2015
New OIG Reports Peg Billing Trends And Prescribing Hotspots As Harbingers Of Part D Fraud
On Tuesday, June 23, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released two reports that hone in on data patterns showing potential fraud and abuse in the Medicare Part D program.
United States
1 Jul 2015
Recent OIG Report Spotlights Millions In Overpayments Caused By Physician Place-Of-Service Coding Errors
On May 6, 2015, the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) released a report on overpayments attributed to incorrect physician place-of-service coding.
United States
19 Jun 2015
The Newborn Screening Saves Lives Reauthorization Act: Implications For Human Subjects Research
On March 16, 2015, the Newborn Screening Saves Lives Reauthorization Act of 2014 went into effect.
United States
9 Apr 2015
FDA Issues Draft Guidance On Use Of Electronic Informed Consent In Clinical Trials
On March 9, 2015, the U.S. Food and Drug Administration released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers.
United States
26 Mar 2015
A Closer Look At The White House’s Precision Medicine Initiative
On January 20, 2015, President Obama announced the upcoming launch of the White House’s Precision Medicine Initiative.
United States
6 Mar 2015
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