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

Bill of Health

Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. Medicaid Spending on Antiretrovirals from 2007-2019. Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. 2022 Oct 5;379:e071752. Value Health.

FDA 184
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HHS OIG Release of New “General Compliance Program Guidance” Provides Valuable Insight on Prevention of Health Care Fraud, Waste, and Abuse

The Health Law Firm Blog

This is the first compliance program guidance the OIG has released since 2008. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), released 91 pages of "General Compliance Program Guidance" (GCPG) on its website. The GCPG provides general compliance guidance, [.]

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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. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. Bakker E, Hendrikse NM, Ehmann F, van der Meer DS, Llinares Garcia J, Vetter T, Starokozhko V, Mol PGM. Clin Pharmacol Ther.

FDA 205
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What you should know about Part B drug payments to comply with IRA 2022

Innovaare Compliance

The Centers for Medicare & Medicaid Services (CMS) has released guidance for implementation of these payment provisions since September 2022, as they are phased in from January 1, 2023 to future years. Between 2008-2021, Medicare Part B drug spending per enrollee grew on average at 9.2 rapid spending growth on biologics; and c).

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The Key Health Care Initiatives Proposed in Governor Hochul’s Fiscal Year (FY) 2025 Executive Budget

Health Care Law Brief

billion to fund Medicaid, $4.8 In addition to the 1115 Waiver, which funds the Medicaid Hospital Global Budget for financially distressed safety net hospitals transitioning from volume-based reimbursement models to value-based models, the HMH Bill would also establish the Healthcare Safety Net Transformation Program (“HSNT Program”).

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What did the HIPAA Omnibus Rule Mandate?

HIPAA Journal

The addition of standards to account for the passage of the GINA Act 2008. The addition of standards to account for the passage of the GINA Act 2008. The adoption of a four-tired civil monetary penalty structure for violations of HIPAA. The finalization of the Breach Notification Rule and the revised “harm” threshold.

HIPAA 78
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North Carolina Woman Pleaded Guilty to a $6.1 Million Medicaid Scheme

The Health Law Firm

A North Carolina woman pleaded guilty on September 14, 2012, for her involvement in a health care scheme that allegedly defrauded Medicaid from 2008 to 2011 for fake mental and behavior health services. Indest III, J.D., Board Certified by The Florida Bar in Health Law. Through this scheme, she allegedly obtained at least $6.1