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

Bill of Health

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues. Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities.

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Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Healthcare Law Today

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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One in Two Americans with Work-Based Insurance Worries That Healthcare Costs Could Lead to Bankruptcy

Health Populi

Health Populi’s Hot Points: U.S. workers with private insurance more likely report poor access to health care, greater costs of care, and lower satisfaction with care versus people covered by public health insurance plans — whether Medicaid, Medicare, VHA or military coverage. One-half of U.S.

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CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors

Healthcare Law Blog

On April 29, 2022 , the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). With a few exceptions, the Final Rule is a wholesale codification of the proposed rule.

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Preventing Unlicensed Individuals and Subsequent Fraudulent Claims Submission

Provider Trust

District Attorney alleges that Pickering was hired in 2019 as a licensed physician’s assistant at a family practice in Norcross, Georgia but had not been a licensed physician’s assistant in Georgia, or any state, since March 2014. According to the U.S. The Importance of Conducting License Verification and Monitoring.

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HIMSS names 2021 Changemaker Award winners

Healthcare IT News - Telehealth

Before joining Geisinger, she served as Pennsylvania’s secretary of health, where she developed an innovative payment and delivery model for rural hospitals. Before that she served as director of the State Innovation Models Initiative at the Centers for Medicare and Medicaid Services. CIO, Delaware Valley Community Health.

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CMS’ Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

Healthcare Law Blog

On January 6, 2022 , the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Enrollee Participation in Plan Governance (§ 422.107). and 422.107).