Regulatory/Legislative News

Here are some of Healio/OSN’s top articles from the virtual American Academy of Ophthalmology annual meeting.

Omidria qualifies for separate payment in ASCs under the CMS policy for non-opioid pain management surgical drugs when used in the ASC setting, according to an Omeros press release.

How do some drugs and devices make it through the FDA approval system, only to show significant, undiscovered flaws? Why do other products never gain approval when they otherwise should?

The Surgical Care Coalition plans to oppose the CMS proposal of a 10.6% decrease to its 2021 Medicare Physician Fee Schedule’s conversion factor, which includes a 6% decrease to ophthalmology payments in 2021, according to a speaker.

The Senate Judiciary Committee is expected to vote on Amy Coney Barrett’s nomination to the Supreme Court tomorrow, Oct. 22.

Omeros Corporation’s 2-year extension of pass-through status for Omidria provided by Congress through the Consolidated Appropriations Act of 2018 expired Oct. 1.

President Donald J. Trump recently signed an executive order detailing his “America First Healthcare Plan,” a combination of old and new initiatives that aim to lower drug prices and insurance premiums.

President Donald J. Trump’s executive order that allows HHS to cap certain prescription drug prices for Medicare to what he called the “most-favored-nation price” will be difficult to implement, experts said.

Several major ophthalmic organizations requested the FDA reconsider its intention to remove moxifloxacin from the 503B bulk drug list, which identifies drug substances for which there is a clinical need.

Novartis and Roche/Genentech are facing a combined 444 million euros in fines from the French Competition Authority for “abusive practices” intended to sustain sales of an expensive product, according to a press release.