CMS proposes new rules for participating in Medicare

"We don't see any problems. I sent them to our membership and didn't receive any negative comments," said Gary Stein, Ph.D., director of federal regulatory affairs for ASHP. "But CMS said more changes are coming. We're concerned those will raise the same problems we had before."

The new and apparently acceptable changes were published by CMS in the March 25 Federal Register. The public has until May 24 to comment on the CMS proposal. If finalized, the changes would revise requirements for completion of history and physical examinations, authentication of verbal orders, securing medications, and completion of postanesthesia evaluations. Their effect on R.Ph.s is minimal, said queried pharmacists, except that medication storage cabinets for Schedule I drugs on most hospital floors or in operating rooms would have to be locked only "when appropriate."

The old proposed changes were more problematic, according to Stein and others. ASHP raised strong objections to the 1997 proposals, which would have made pharmacist oversight of the medication-approval process optional rather than mandatory and eliminated the requirement of a hospital formulary system.

"The complete removal of the requirement for a qualified pharmacist responsible for developing, supervising, and coordinating all activities involved in pharmaceutical care dismisses a vital component of the organizational fabric of the safety net that supports patient care," ASHP wrote to the feds in a 1998 letter. The letter also noted that a "formulary system," wherein R.Ph.s participate in an evaluation of the efficacy of any drugs used in a hospital, is a "major tool for improving quality" and should continue to be a CoP requirement. And the letter raised concern that a proposed medication error target of no greater than 2% would create a punitive environment and inhibit the reporting of errors.

The March 25 proposal said this about why the 1997 proposals haven't been adopted: "While our initial intention was to finalize the Dec. 19, 1997, proposed rule in its entirety, delays within CMS ... led us to reevaluate this objective in light of concerns expressed by providers."

"We remain concerned about those issues, even though they weren't finalized," said Stein. "But CMS could now either make the changes outright, because they've already had public comment, or come out with a new proposed rule based on the comments they got."

The American College of Clinical Pharmacy concurred with ASHP in 1998 and continues to do so today, said C. Edwin Webb, Pharm.D., director of government and professional affairs for ACCP. "There's nothing [in the new proposed changes] that is of concern," he said. "But we're going to continue to monitor this situation and see if this is part of a larger initiative."

The concerns of ASHP and ACCP are appropriate, said Timothy Lesar, Pharm.D., director of the department of pharmacy at the Albany Medical Center. "Those proposals, if adopted, could open a door to a lack of control over those things we should be most responsible for," he said.