MEDGuide and patient package inserts--again?

This article will trace the history and effects of the PPI from the time of its original concept by the FDA in the early 1970's to its current status. It will also address the response to this FDA initiative by the industry, medical community and consumer groups. Initiatives in other countries and future issues will also be discussed.     

The State of American Federalism, 1996-1997

Federalism enjoyed political and popular salience during theperiod 1996–1997 as the so-called "Devolution Revolution"began to be implemented and analyzed in the United States. Whilethere were a few examples of important Revolutionary efforts,the federal government continued to hold much of the power andsignificance it has achieved over the past sixty years. Evenin the area of welfare policy, where in 1996 there were historicreforms enacted to end the federal entitlement, the federalgovernment maintained a significant presence that made the ideaof devolution of welfare policy responsibility some what questionable.Nevertheless, states continued to lead in policy innovationin areas ranging from education to health, and the U.S. SupremeCourt continued to question the limits of federal power. Thepast year illustrated, once again, the complexity of our federalsystem and how difficult it is to reform federalism—particularlywhen it involves a shift in power and creates the perceptionof winners and losers.     

Mental disabilities under the ADA: a management rights approach

While numerous sources have focused on employee rights and employer obligations under the Americans with Disabilities Act, this article will emphasize employer rights with respect to mental disabilities under the ADA. Specifically, it addresses the ADA's definition of "mental disability," the right of employers to screen job applicants in spite of the ADA, the conditions under which an employer may require an employee to undergo a "fitness for duty" examination, and the limits of the duty to "reasonably accommodate" an employee with a mental disability.     

Issues raised by respiratory therapy arrangements

In large part due to the foregoing issues, Medicare program officials have focused on respiratory therapy as an area with great potential for abuse, and may well introduce significant reforms in the near future. Accordingly, any contractual arrangements for respiratory therapy programs of the type discussed above should be carefully reviewed for compliance with Medicare requirements and for a realistic assessment of the parties' potential exposure to liability under the anti-kickback statute. At a minimum, these agreements should provide for short "without cause" termination provisions, or include a so-called "jeopardy" provision that permits the parties to renegotiate or terminate their contract if significant changes occur in, or if the current arrangement is found or threatened to be found to violate, applicable law.