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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. Medicare’s National Coverage Determination for Aducanumab – A One-Off or a Pragmatic Path Forward? Medicaid Spending on Antiretrovirals from 2007-2019.

FDA 184
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What you should know about Part B drug payments to comply with IRA 2022

Innovaare Compliance

The Inflation Reduction Act of 2022 has wide-ranging impact on payments for drugs used by Medicare beneficiaries, whether they are administered in the provider’s office (Part B) or used in the ambulatory setting (Part D). Part B drugs have had the fastest spending growth for drugs for Medicare. percent annually.

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Monitor Improper Payments for Part C and Part D with Medicare Audit and Monitoring Software

Innovaare Compliance

The monthly premium for Medicare Part B rose 14.5%, from $148.50 By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1] By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1]

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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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Why Data Analytics are Critical in a Value-Based Care (VBC) Environment

AIHC

Medicare changed reimbursement methodology in the 1980s by introducing Relative Value Units (RVUs) and the RBRVS (Resource-Based Relative Value System) for physician reimbursement. MA/HMO) is typically used by Health Maintenance Organizations and Medicare Advantage Organizations. healthcare system were exorbitant. Capitation (e.g.,

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The Importance of NCQA Certification for CVOs

Verisys

It allows organizations to stay compliant with state and federal requirements and maintains their accreditation with Medicare, Medicaid, TRICARE, and other programs. Verisys has been NCQA and URAC accredited since 2008. NCQA certification has become essential to identifying industry standards and quality.