The National Law Forum

The Blog of the The National Law Review

Category Archives: Health Care Law

FDA Flunks Mylan’s India Facilities, Finds cGMP Violations

pills, close-up

When we open our medicine cabinet, we take for granted that the drugs we find there are safe and properly labeled. Many physicians privately worry, however, about the safety and efficacy of prescription drugs. About 85% of the prescription drugs sold in the United States are manufactured offshore. Many of those offshore drugs are made …

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Medical Record Retention

pen and paper (1)

I am often asked how long a practice must maintain medical records. The answer depends on the type of provider you are and your risk tolerance. Providers should generally consider the following in establishing their record retention policies: 1. Patient care. The primary consideration should be patient care. Some practices (e.g., oncology) may want to …

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Amarin Ruling Solidifies Off-Label Marketing Options but Raises Questions About False Claims Act Enforcement Action

pills, close-up

The Southern District of New York recently ruled in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al. that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act. No. …

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False Claims Act: Do You Really Have Just 60 Days to Repay?

money, dollar sign

One of your employees informs you of a potential overpayment from Medicare. Do you really only have 60 days from that point to determine if it is indeed an overpayment and repay it? The Patient Protection and Affordable Care Act of 2010 requires that a person who receives an overpayment of Medicare or Medicaid funds …

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Four Ways Medicare and Medicaid Have Changed the Health Care Industry

healthcare background

It’s a bizarre program that is absolutely essential to American healthcare. That is the opinion of Theodore Marmor, professor of public policy at Yale and author of the book, The Politics of Medicare. Whether you agree with him or not, it is difficult to deny the influence of Medicare and Medicaid on the health care …

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