FDA

Pfizer’s COVID-19 Vaccine Granted Full FDA Approval As CMS Ups Its Reimbursement

by Emily Sokol, MPH

COVID-19 remains in the spotlight of this week’s policy recap as Pfizer-BioNTech’s COVID-19 vaccine is granted full FDA approval. And CMS boosts reimbursement rates for COVID-19 vaccines...

CDC Updates Masking Guidelines as Long COVID Added to ADA

by Emily Sokol, MPH

This week’s policy update highlights the CDC’s new masking guidelines, triggered by the spread of the Delta variant. Meanwhile, long COVID was added to the list of qualifying disabilities...

Controversial Alzheimer’s Drug Under CMS, FDA Watch; EO Looks to Prescription Drug Spending

by Emily Sokol, MPH

CMS announced it will begin coverage determination investigations for the controversial Alzheimer’s drug, Aduhelm, while the drug’s approval process is also being investigated by the FDA....

Executive Order Includes Focus on Hospital Mergers; FDA Requests Investigation into Approval of Biogen’s Aduhelm

by Kyle Murphy, PhD

Happy Tuesday! Folks on either coast of the United States are facing either record high temperatures or levels of rainfall. As is the case most times, meteorologists are the only ones satisfied. FDA...

FDA, CMS, HHS Improve COVID-19 Testing, Vaccination; Provider Relief Fund Deadlines Extended

by Emily Sokol, MPH

To improve access to COVID-19 testing and vaccination, FDA, CMS, and HHS are increasing vaccine supplies, vaccination sites, and funding. Meanwhile, HHS extended key reporting deadlines for the...

Resignations Follow FDA approval of Alzheimer’s Drug; University Hospitals Focuses Healthcare Consumerism

by Kyle Murphy, PhD

The approval by FDA of Biogen’s Alzheimer’s drug Aduhelm has led to the resignation of three committee members, citing disagreement with the department’s decision. The efficacy of the...

HHS Warns Against COVID-19 Vaccination Costs to Patients; Recapping FDA’s Controversial Approval of Biogen’s Adulhem

by Kyle Murphy, PhD

It’s been a busy week in healthcare, beginning with FDA’s approval of Biogen’s Alzheimer’s drug, Aduhelm, which continues to draw the ire of industry experts across the...

Biden Admin Boosts Pharma Supply Chain Amid FDA Alzheimer’s Drug Approval

by Emily Sokol, MPH

In an effort to reduce the US reliance on the global pharmaceutical supply chain, the Biden Administration accepted recommendations for improving the US supply chain. Meanwhile, the FDA approved a...

CMS Chooses Press Ganey for Primary Care Patient Surveys; Sentara, Cone End Merger Plans

by Kyle Murphy, PhD

Happy Friday after a long short week of work. Many of us in the Northeast will be scrambling to the coast to get some sun following a bleak and dreary Memorial Day Weekend. Press Ganey Gets OK from...

DOJ Targets Telefraud; CMS Delays Value-Based Drug Payments

by Emily Sokol, MPH

As the DOJ sets its eyes on COVID-19-related telefraud, CMS called for public comments on delaying value-based drug payment rules. Meanwhile, a new Senate bill proposes expanding VA mental health...

Local Vaccine Efforts Ramp Up As Special Enrollment, Treatment Coverage Expands Access

by Emily Sokol, MPH

The Biden Administration announces additional funding for vaccination efforts as local vaccination campaigns are slated to push the United States to herd immunity. And HHS announces over one million...

FDA Examines Cancer Drug Effectiveness; HHS Promotes Care Access, Marketplace Enrollment

by Emily Sokol, MPH

The FDA remains busy as Johnson & Johnson vaccine review ends and cancer drug approval discussions commence. Meanwhile, HHS allocates funding to medically underserved health centers to improve...

HHS Supports Community-Based Organizations, Changes to Title X; CMS Delays Reimbursement Cuts

by Emily Sokol, MPH

HHS announced funding to support community-based organizations in their battle against COVID-19 and proposed changes to Title X to promote more equitable care delivery. Meanwhile, CMS delays...

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