Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


CMS starts freezing regs

Executive Summary

A Federal Register notice announcing a 60-day extension of the effective date and comment period for a final rule on Medicaid premiums and cost sharing, originally published Nov. 25, will be the first freeze of a CMS pending rule after President Obama's Jan. 20 memo requesting such government-wide action on all pending regulations. The notice was put on display in the Office of the Federal Register Jan. 23. The freeze memo applies to any federal regulations that did not take effect before Obama took office on Jan. 20. Therefore, the rule on Medicare Part D protected classes is not expected to be affected by the freeze because it went into effect Jan. 16 (1"The Pink Sheet," Jan. 19, 2009, p. 14)

You may also be interested in...

CMS Opens Way To Add, Or Subtract, Protected Classes In Part D Formularies

CMS is creating a multi-step process that will give outside experts and the public a role in adding or subtracting "protected" drug classes in Medicare Part D, as well as making exceptions to the rule that all drugs must be covered in a protected class

COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges

A senior Pfizer executive talks about the high regulatory expectations for public disclosure of clinical trial data for Comirnaty, the COVID-19 vaccine it developed in partnership with BioNTech. There were also concerns about re-identification of trial participants as many subjects took to social media to share their experiences with the Comirnaty study.

Top Senator ‘Disappointed’ With Missing MDUFA Package

Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts