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WEBOct 26, 2021 · One of the final healthcare actions made by the Trump Administration has been rescinded by the Biden Administration.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 ...
Physician Payment Sunshine Act: CMS Releases Fact Sheets
WEBApr 12, 2013 · The Centers for Medicare & Medicaid Services (CMS) updated the Open Payments website to include fact sheets for applicable manufacturers, applicable group purchasing organizations (GPOs), teaching hospitals and physicians who will be affected by the Open Payments, commonly known as “Sunshine,” final rule.. The Physician Payments Sunshine Provision of the Affordable Care Act (Section 6002 ...
New Final Rule in Effect Updating AKS Safe Harbors
WEBOn January 19, 2021, a final rule promulgated by the Department of Health and Human Services Office of Inspector General (HHS OIG) took effect, updating the safe harbors under the Federal Anti-Kickback Statute (AKS) and adding a new exception to the Beneficiary Inducements Civil Monetary Penalties (CMP).. The hope of the final rule is that it will protect certain value-based arrangements and ...
FDA Releases Two Draft Guidance Documents on REMS
WEBAug 23, 2018 · In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a shared system Risk Evaluation and Mitigation Strategy (REMS), and waivers associated with the single, shared system REMS requirement. FDA Commissioner Scott Gottlieb has spoken about the way pharmaceutical sponsors can exploit REMS to block generic drugs from making a ...
Government Intervenes against Device Manufacturer Spine …
WEBSep 30, 2020 · Specific allegations include that the Defendants: Reconsidered their practice of offering direct ‘consulting’ agreements and investment opportunities to surgeons after the 2013 announcements of the Open Payments program and HHS-OIG’s POD Special Fraud Alert (e.g., a sales representative wrote to a prospective surgeon in March 2014 that SpineFrontier’s partnership with IME “eliminates ...
Risk Evaluation and Mitigation Strategies (REMS) Summary
WEBFeb 3, 2011 · One of the new provisions gave FDA the authority to require that companies submit Risk Evaluation and Mitigation Strategies (REMS) when deemed necessary to ensure that a drug or biological product’s benefits outweigh the risks. FDA may now require REMS for any New Drug Application (NDA), Abbreviated New …
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 …
Prior Authorization Changes Driven by the COVID-19 Pandemic
WEBJul 15, 2020 · Below is a chart summarizing key policy changes major insurance companies have implemented related to PA in response to the COVID-19 pandemic. · PA waiver effective March 24, 2020 – May 31, 2020. · Improved patient access by allowing members to call and speak to a pharmacist. PA: Prior Authorization. UnitedHealthcare.
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.
Physician Payments Sunshine Act Final Rule: Quick Reference Guide
WEBFeb 13, 2013 · The total amount of civil money penalties will not exceed $150,000. Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment. The penalty will not exceed $1,000,000. Combined, penalties may not exceed $1,150,000.