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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. 2022 Feb 19. Emergency Use Authorizations of COVID-19-Related Medical Products. Bakker E, Hendrikse NM, Ehmann F, van der Meer DS, Llinares Garcia J, Vetter T, Starokozhko V, Mol PGM. 2022 Feb 9.

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HHS Aims to Strengthen Anti-Discrimination Rules for Disabled Patients in New Proposed Rule

C&M Health Law

Section 504 covers all health care and human services programs and activities funded by HHS, from providers, like hospitals and doctors that accept Medicare or Medicare, to state child welfare programs, as well as Medicare Advantage Plans, and Medicaid Managed Care Plans. Comments may be submitted until November 13, 2023.

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Recent Developments in Telehealth Enforcement

Healthcare Law Blog

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. On October 13, 2022 , Health and Human Services (“HHS”) Secretary Xavier Becerra renewed the COVID-19 PHE and the PHE is now set to expire on January 11, 2023. Ryan Haight Act. Mark Warner , and industry groups.

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DOJ Releases FY 2021 False Claims Act Recoveries: A Record-Shattering Year for Health Care and Life Sciences Enforcement, with Over $5 Billion Collected

Health Law Advisor

According to DOJ’s statistics, the government paid out $238 million to relators in FY 2021, the lowest number since FY 2008. WHISTLEBLOWER ACTIONS AND AWARDS REACH DECADE LOW. Total awards to relators also fell in FY 2021 to the lowest number in over a decade. INCREASE IN RECOVERIES FROM DECLINED QUI TAM CASES. KEY TAKEAWAYS.

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Value-Based Health Care Needs All Stakeholders at the Table – Especially the Patient

Health Populi

health care, patient assistance programs, Medicare Advantage plans, and the bundling of proven high-value preventive services into the Affordable Care Act. In the case of Medicare Part D, the drug benefit, Chandra said, “If you’re sick enough to fall into the donut hole, you may have higher mortality.”

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DOJ’s FY 2022 False Claims Act Recoveries: A Mixed Bag

Health Law Advisor

Lowest Total Recoveries Since 2008 Record-Shattering Number of New Cases Filed Health Care and Life Sciences Cases Continue to Dominate On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022. [1]

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COVID-19 as Disability Interest Convergence?

Bill of Health

Some have suggested that the COVID-19 pandemic could be a moment of what critical race theorist Derrick Bell called “ interest convergence ,” where majority interests align with those of a minority group to create a critical moment for social change. Why Haven’t Interests Converged During the COVID-19 Pandemic?

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