THE ACCIDENTAL ENTREPRENEUR PART V video
THE ACCIDENTAL ENTREPRENEUR PART V Podcast
Health Reimbursement Arrangement Update
Podcast: Health Reimbursement Arrangements
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination...more
On February 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Decision Memo outlining revisions to its 2005 National Coverage Determination (NCD) for Implantable Automatic Defibrillators (ICDs) ....more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more
I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more
There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more