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

Bill of Health

The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. 2022 Jun 21.

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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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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? 2022 Oct 5;379:e071752. N Engl J Med.

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Medicare Members Are Health Consumers, Too – Our AHIP Talk About Aging, Digital Immigrants, and Personalizing Health/Care

Health Populi

That program has the potential to change our Medicare members manage meds at home to ensure better adherence, supporting better health outcomes and personal feelings of efficacy and control. [As Those born before 1985 are generally considered as digital immigrants, so people aging into Medicare today are certainly in that cohort.

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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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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.

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