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Public life sciences companies uniquely positioned as SOX retaliation defendants

Sarbanes-Oxley’s (SOX) whistleblower protections can create tricky issues for public life sciences and health care companies. Consider taking steps now to help mitigate these risks.

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OIG green lights drug manufacturer-sponsored genetic testing program

On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical...

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PhRMA responds: Code on Interactions with HCPs updated following fraud alert on speaker programs

On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals...

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Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

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Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates...

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OIG signals “significant concerns” with company-sponsored speaker programs

On November 16, 2020, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically ...

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OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to...

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AbbVie settlement seems to end period of intense scrutiny for manufacturer patient support programs

Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve...

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CMS’ 2021 health insurance exchanges rule finalizes pharmaceutical manufacturer coupon policy shift

On May 7, 2020, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Notice of Benefit and Payment Parameters final rule (“2021 NBPP Final Rule”), finalizing ...

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