Regulations

Hospitals Wait as CMS Seeks More Input on Clinical Trial Rules

By Amy Lillard

More community hospitals are doing research, but coverage decisions linger

More community hospitals are doing research, but coverage decisions linger

What was supposed to be big news in the world of clinical research this July turned into a waiting game, as the Centers for Medicare & Medicaid Services postponed a ruling on trial coverage.

Even bigger news: Who the waiting game affects.

For years, clinical researchers have had to navigate complex rules dictating which trials and procedures are covered by Medicare and Medicaid. CMS faced uproar after proposing additional coverage restrictions earlier this year. Its July announcement was supposed to clarify things. Instead, CMS wants more input.

Surprisingly, the input CMS seeks is not just from clinicians at academic medical centers; it is also looking to local community hospitals, which are increasingly involved in research projects.

Jennifer Geetter, a partner at McDermott, Will and Emery and a legal adviser in health care clinical research areas, says patients want access to clinical research, and they want it conducted by the hospital and doctors they trust. Physicians are also attracted to sites that conduct clinical research.

“First and foremost, to develop a research program you must make sure you have an appropriate infrastructure,” says Dale Beatty, vice president of client services and chief nursing officer at Northwest Community Hospital, Arlington Heights, Ill., which has a long history of conducting clinical research. “You need a process to evaluate the ethics of research, the feasibility of research being conducted, and a mechanism to protect patient’s rights and safety. Once you have the structure, you need a method of communicating and educating your organization on research.”

One worry administrators may have about implementing a research program, especially considering the uncertainty surrounding the CMS rules, is cost and liability concerns. Beatty contends that creatng a program is well worth it.

This article 1st appeared in the October 2007 issue of HHN Magazine.

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