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WV

William V. Donovan

10 articles

Articles by William V. Donovan

Is “Medicare for All” Gaining Political Traction?

Is “Medicare for All” Gaining Political Traction?

The inexorable rise of Medicare spending (5.5% per year as far as the Federal Budget Analysts can see) is leaching into the broader political debate and starting to find expression among Democratic Presidential candidates in the form of Medicare-for-All and Medicare-Buy-In-Over-50 plans and the status of the Affordable Care Act (ACA). Bernie Sanders, arguably the […]

Mar 5, 2019
FDA to Require Opioid Blister-Packs-Prescribing Guideline in 2020?

FDA to Require Opioid Blister-Packs-Prescribing Guideline in 2020?

The Food and Drug Administration (FDA) plans to require that prescribed immediate-release opioids may no longer be packaged in plastic bottles but must come in sets of blister packs with durations as short as two days. Also, FDA will publish a report proposing at least some of the scientific-evidence-based opioid-prescribing guidelines it promised last year […]

Mar 4, 2019
Accountable Care Organizations Hit Again – This Time by NEJM

Accountable Care Organizations Hit Again – This Time by NEJM

A January 31 New England Journal of Medicine opinion piece expressed doubt that Accountable Care Organizations (ACOs) can be expected to save money. The National Association of Accountable Care Organizations (NAACOS) didn’t post a response, but an online magazine did, and it doesn’t seem to support the fundamental claim that ACOs’ cut healthcare costs. In […]

Mar 1, 2019
Patients Going to Medicare as Health Costs Rise

Patients Going to Medicare as Health Costs Rise

The Center for Medicare and Medicaid Services (CMS) issued a report February 20 projecting that total U.S. health care expenditures will rise faster than in recent years, from $3.49 trillion in 2017 to $5.96 trillion in 2027, an average of about 5.5% per year. Drilling deeper: Physician and clinical services revenue will soar, and the […]

Mar 1, 2019
Who Is Liveyon and What Are They Really Selling?

Who Is Liveyon and What Are They Really Selling?

Liveyon, after an infection scandal, seeks to go national with a new allograft product line which also raises regulatory questions.

Mar 1, 2019
Proposed Federal Rule Puts Patient Records on Smart Phones

Proposed Federal Rule Puts Patient Records on Smart Phones

It’s all about portability. A federal regulation proposed February 11 would require physicians’ offices to not only share medical records electronically with patients via their smart phones, but to implement systems which let patients electronically transfer those medical records to another care provider if the patient requested it. In some cases, patients will want to […]

Feb 18, 2019
Opioids: The Action Turns Away from Simply Punishing Physicians

Opioids: The Action Turns Away from Simply Punishing Physicians

Federal and state actions on opioids are turning away from simply targeting physicians, and there are even signs of a return to balance when it comes to prescribing. In one dramatic turn, a bed ridden patient was wheeled into Congress to deliver a heart rendering plea for sanity. Is the tide turning?

Feb 18, 2019
Ambulatory Surgical Center Infections: Awful Headlines in NJ

Ambulatory Surgical Center Infections: Awful Headlines in NJ

All kinds of media hell are breaking loose in New Jersey over infections at HealthPlus ambulatory surgery centers. How will this affect other ASCs in New Jersey or, for that matter, the adjacent media markets in New York and Pennsylvania? If forewarned is forearmed, then this story is a must-read.

Feb 8, 2019
FDA’s Sort-of-Final 510(k) Proposal

FDA’s Sort-of-Final 510(k) Proposal

The Food and Drug Administration (FDA) on January 22 posted a new, more-or-less final plan to change the 510(k) medical device process, pending public comments (again). There’s a lot to pay attention to here.

Feb 5, 2019
NDA Approvals on a 9-Year Surge; 510(k) Stats – Flat

NDA Approvals on a 9-Year Surge; 510(k) Stats – Flat

FDA Commissioner Scott Gottlieb and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health (CDRH), issued a statement January 28 patting themselves on the back for speeding up approvals of new medical devices. But did they, really? Looking back: In the year 2009, as Barack Obama was taking over as President of […]

Feb 4, 2019
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