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This week in Washington: Congress passes funding bill for an additional week to come up with full-year spending legislation to avoid a government shutdown.
Administration
FDA Announces It Will Quickly Authorize Pfizer Vaccine
CMS Releases Information on the Best Practices for Designing and Implementing Substance Use Disorder (SUD)-Focused Health Homes
Proposed Rules
CMS Proposes New Rules to Address Prior Authorization
Final Regulations/Guidance
Courts
Reports
GAO: Medicaid - CMS Needs More Information on States’ Financing and Payment Arrangements to Improve Oversight
Administration
Trump Signs One-Week CR Spending Bill
Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled,
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses i
the criticism of the mueller view is they re trying to make manafort like he had fancy coats and fancy brands. legally, that s not the problem and unfair and all they have to prove is tax evasion. do you think the judge is hitting that right and fairly? i think he is, although he does bring it up a lot. i d say roughly hour or two he makes a comment about manafort is not on trial for being rich or having a lavish lifestyle or extravagant tastes and prosecutors often agree with the judge but insist they need to show the value of these luxury goods that manafort was getting them to convince jurors his tax returns could not cover the lifestyle he was living in addition to proving this point of the very very strange payment arrangements. nearly every vendor that came up said they were paid by overseas wire transfers from shell
they re trying to make paul manafort out like he s sean diddy coves and had fancy coats and fancy brands and that legally, there s not the problem. it s kind of unfair and what they really have to problem is that there was tax evasion. do you think the judge is hitting that right and fairly? i think he is. he does bring it up a lot. i d say roughly every hour or two, he makes a comment about manafort is not on trial for being rich or for having a lavish lifestyle or extravagant tastes and the prosecutors will often agree with the judge but they insys they need to show the value of these luxury goods and that manafort was getting them to really convince jurors that manafort s tax returns could not possibly have covered the lifestyle that he was living in addition to trying to prove his point of the very, very strange payment arrangements, nearly every vendor who came up said they were paid by overseas wire transfers from shell companies whose names they had never heard
fines of $21,750 in fees. a spokesman told the detroit free press it s another example of money that we re not getting that s due to us. these people should be put on notice. if you re flat-out stealing, we re coming after you as well. the city says it has funds available to help people who can t afford their bills, and in a statement given directly to the reid report said in part, that it urges residents to reach out to make payment arrangements and avoid shut off. but with thousands of people losing access to running water, the question is, are we witnessing a humanitarian crisis right here in our own country? and joining me now, david alexander bullock, a detroit pastor and national spokesman for the change agent consortium, a citizens organization that improves access to food, job skills, and economic development. joining me by phone is maude barlow of the council of canadians. maude, i m going to start with you. i m told you plan to lead a