Healthcare Law Blog

NOVEMBER 1, 2022

CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs). FOOTNOTES. [1]

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Health Populi

OCTOBER 24, 2022

These are shown in the first diagram from the report, breaking out factors that have exacerbated challenges on both the demand and supply side of the American health economy. Many of these were already in motion before the COVID-19 pandemic emerged; the public health crisis exacerbated several of them. In the U.S.,

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COVID-19 Prescription Drug Pricing Health Insurance Health Care Reform 54

Healthcare Law Blog

APRIL 6, 2022

The COVID-19 pandemic has also affected Medicaid postpartum coverage. The Families First Coronavirus Recovery Act, passed on March 18, 2020, includes increased federal funding for state Medicaid agencies to provide care during the national public health emergency. 31, 2022). [2] 2] Emily E. Peterson, et. 3] Madeline Y.

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SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

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US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare Law Blog

JANUARY 10, 2022

Entering the third year of the COVID-19 public health emergency, CMS seeks to clarify the period of time during which MAOs must comply with the special requirements at 42 CFR 422.100(m) to ensure access for enrollees to covered services throughout the disaster or emergency period.

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Health Populi

OCTOBER 15, 2020

More than four times as many Black women believe that it’s a bad time to be Black in America in 2020 versus 2011, we learn from The Undefeated Survey on Race and Health from Kaiser Family Foundation (KFF). More White Americans ranks COVID-19 as the top concern (29%) compared with financial (26%).

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COVID-19 Public Health Governance Health Insurance 86

Hall Render

MARCH 16, 2022

billion in new COVID-19 emergency funding requested by the White House was removed at the last moment after some rank and file House Democrats objected to a cost offset that rescinded $7 billion in unused state and local government aid from previous COVID-19 relief laws. A section of the bill that would have provided $15.6

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New Jersey Healthcare Blog

JANUARY 12, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: On October 4, 2021, at 53 N.J.R. 103, which declared a Public Health Emergency for the state in response to COVID-19. Effective October 19, 2021. Definitions and 4.1,

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SQA

JUNE 3, 2024

9 Lessons Learned from the COVID-19 Pandemic, January 2024 As a result of the COVID-19 pandemic, many industries (the pharmaceutical included) went through a substantial disruption. For many pharmaceutical companies, challenges increased as they raced to provide a vaccine or a therapeutic treatment for COVID-19.

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C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. 19) Klinker v. The plaintiff in M.T. must be a piece of work. 23, 2023) ( here ).

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FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

MARCH 30, 2023

We should not be startled to see that this flip side of COVID-era litigation also persists in 2023. The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. IMS Health, Inc. , Instead, the Missouri law clearly picked a side.

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