The posted guidance document can be used by covered entities to design and implement a contingency plan.

Moreover, a public health authority may also be a covered entity.

If the covered entity does agree to a restriction, it must generally abide by the agreement, except for emergency treatment situations.

Thus, the covered entity would not need to annotate each patient's medical record whenever a routine public health disclosure was made.

It also requires covered entities to take reasonable steps to ensure the confidentiality of communications with individuals.

Individual covered entities can evaluate their own situation and determine the best way to implement addressable specifications.

These changes are also required to be included in any business associate agreements with covered entities.

The number of covered entities that participate in the 340B program has grown from 8,605 in 2001 to 16,572 in 2011.

The Department will investigate complaints and conduct compliance reviews of covered entities.

A "subsequent" violation would not be found until the Department brought a second suit against the same covered entity.