Healthcare Law Blog

JANUARY 10, 2022

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Key provisions of the Proposed Rule are summarized below. Comments are due by March 7, 2022.

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Bill of Health

FEBRUARY 13, 2024

Frequently labelled a scholar-activist, she combines academic research and scholarship that bridges law, development, and public health with grassroots work and policy advocacy. Although I’m the only Senior Fellow focusing on global health work at PFC, affiliated researchers also contribute enormously to GHRP. 1991), M.P.H.

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Healthcare Law Blog

JANUARY 26, 2023

BACKGROUND The Proposed Rule is the latest in a long line of federal legislation and rulemakings governing the conscience rights of healthcare providers and entities. The Church Amendments In the 1970s, the federal government enacted the Church Amendments, 42 U.S.C.

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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

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. But those good intentions and the fact that their employer is engaged in health care do not exempt such innovators from FDA oversight.

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FDA Licensing Hospitals Medicaid 98

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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Medicaid Medicaid Medicare Medicare 104

Hall Render

MARCH 16, 2022

2471 ) that funds the federal government for the remainder of FY 2022. The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. million increase. billion increase.

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COVID-19 Medicare Medicare FDA 40

Drug & Device Law

DECEMBER 29, 2023

Executive Health Resources, Inc. , 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether.

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

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted). 300aa-11(a)(2)(a).

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FDA Public Health Fraud Hospitals 115

Drug & Device Law

OCTOBER 7, 2022

While most contraceptives are short-acting, in part to allow for the possibility of conception when desired, there is clearly a role from public health perspective—among other perspectives—for long-acting and permanent contraception. (Our posts go back for more than six years.) The facts of Garcia are sparse. 2022 WL 4536240, *1.

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FDA Fraud Doctors Public Health 59

Drug & Device Law

MAY 10, 2022

Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency. Finally, they cannot use the word “recall” except “when referring to a product that has been recalled by a government agency or through an agreement between a manufacturer and government agency.”

Governance 52

Governance FDA Doctors Public Health 52

Drug & Device Law

MARCH 30, 2023

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health.

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