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Alston & Bird Health Care Week in Review - February 2021 #3 | Alston & Bird


Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS announced new actions to expand COVID-19 testing capacity across the country. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On February 18, 2021, the Food and Drug Administration (FDA) issued a notice entitled,
Guidance Documents Related to Coronavirus Disease 2019; Availability. The FDA is announcing the availability of FDA guidance documents related to the COVID-19 public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances id ....

United States , District Of Columbia , South Carolina , Lathran Woodard , Helened Gayle , Frankie Miranda , Meeting Of The Center , Department Of Defense , Us District Court , Price Transparency In Health Care , Pfizer Inc , Department Of Health , Ethnic Health Inequities , Technical Expert Panel , Congressional Budget Office , Centers For Disease , Service Fees , Mental Health Services Administration , Drug Administration , Kaiser Family Foundation , Meeting Of The Arthritis Advisory Committee , Chicago Community , Products Advisory Committee , Agency For Healthcare Research , Biden Harris Administration , Celltrans Inc ,

Pharmaceutical Companies Beware: New Final Rule Changes Existing Anti-Kickback Statute Discount Safe Harbor Provisions | Arnall Golden Gregory LLP


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In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription drugs paid by manufacturers to or purchased by Medicare Part D plan sponsors or pharmacy benefit managers (PBMs) acting under contract with Medicare Part D plan sponsors from the existing discount safe harbor under the federal Anti-Kickback Statute (AKS).
1  The regulation reflects the first change to the AKS discount safe harbor since the Medicare Part D program was established. ....

Service Fees , Medicaid Managed Care Organization , Human Services , Department Of Health , Anti Kickback Statute , Partd Plan , Safe Harbor Protection , New Safe Harbor Protection , Certain Point Of Sale Reductions , Prescription Pharmaceuticals , Certain Pharmacy Benefit Manager Service Fees , சேவை கட்டணம் , மருத்துவ உதவி நிர்வகிக்கப்பட்டது பராமரிப்பு ஆர்கநைஸேஶந் , மனிதன் சேவைகள் , துறை ஆஃப் ஆரோக்கியம் , பாதுகாப்பானது துறைமுகம் ப்ரொடெக்ஶந் , புதியது பாதுகாப்பானது துறைமுகம் ப்ரொடெக்ஶந் , ப்ரிஸ்க்ரிப்ஶந் மருந்துகள் , சிஇஆர்டிஏஐஎன் மருந்தகம் நன்மை மேலாளர் சேவை கட்டணம் ,