Tags » Health Care Law

FDA Flunks Mylan’s India Facilities, Finds cGMP Violations

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. 673 more words

Health Care Law

Medical Record Retention

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. 444 more words

Health Care Law

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

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. 741 more words

Health Care Law

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

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? 489 more words

Health Care Law

Four Ways Medicare and Medicaid Have Changed the Health Care Industry

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…

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Health Care Law

Affordable Care Act Reporting Penalties Significantly Increased

On June 29, 2015, President Barack Obama signed the Trade Preferences Extension Act (the Act) into law. In addition to containing several revenue offsets, the… 404 more words

Health Care Law

Employer Next Steps Post-Affordable Care Act Ruling

What should employers be thinking about now that the US Supreme Court has upheld the Affordable Care Act’s (ACA’s) premium assistance structure in King v. Burwell… 183 more words

Labor & Employment