Medicare Clinical Trial Coverage For IND-Exempt Trials Sought By PhRMA

PhRMA is urging the Health Care Financing Administration to include permanent automatic qualification for IND-exempt trials in its Medicare clinical trial coverage policy.

The Pharmaceutical Research & Manufacturers of America "is disappointed that the final coverage decision provides only temporary 'deemed status' for drug trials that are exempt from having an IND," the association stated in an Oct. 18 letter to the Agency for Healthcare Research & Quality, which is helping define the coverage criteria for HCFA.

Although IND-exempt drug trials currently enjoy automatic qualification status for Medicare coverage, they would be subject to self-certification subsequent to the development of qualifying criteria, according to a HCFA final Medicare coverage policy decision issued Sept. 19.

"The principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs," the HCFA policy states.

The proposed coverage decision, issued in August, provided for automatic coverage of IND-exempt trials.

INDs are not required for the study of a new indication of a marketed drug or for comparative study of FDA-approved drugs, PhRMA said.

PhRMA also expressed concern with AHRQ's efforts to compile a registry of all clinical trials approved for Medicare coverage. AHRQ is partnering with NIH's National Library of Medicine to create a database which will allow users to distinguish trials eligible for Medicare coverage, AHRQ said.

HCFA's national coverage decision was implemented after a June 7 presidential executive memorandum directed Medicare to reimburse routine patient care costs associated with participation in clinical trials.

President Clinton's directive attempts to address the lack of enrollment of seniors in clinical trials (¹ (Also see "Clinical Rx Trials Could Gain HCFA Financial Support Under Clinton Directive" - Pink Sheet, 12 Jun, 2000.)).

"PhRMA member companies have seen the disincentive for patients and providers to enroll in clinical trials that has resulted from the lack of clarity regarding Medicare policy," the PhRMA letter states.

HCFA guidelines provide automatic coverage for trials conducted under an investigational new drug application and trials funded by NIH, CDC, AHRQ, HCFA, DoD or VA.

In order to receive Medicare coverage, other trials must evaluate an item or service that falls within a Medicare benefit category, must "have therapeutic intent" and not be designed exclusively to test toxicity or disease pathophysiology, and must "enroll patients with diagnosed disease rather than healthy volunteers," the policy states.

Additionally, HCFA expects clinical trials to attempt to determine whether the intervention potentially improves the participants' health outcomes and avoid duplication of existing studies.

AHRQ has convened a multi-agency federal group, pursuant to HCFA's request, "to develop readily verifiable criteria by which to identify trials that meet an appropriate standard of quality," AHRQ said.

Criteria could be established in early 2001, AHRQ indicated. The AHRQ task force met Oct. 20 to gather public comment that would aid the group in defining qualifying criteria to identify trials suitable for Medicare coverage.

AHRQ Administrator John Eisenberg, MD, leads a 16-member group from CDC, DoD, FDA, NIH, NLM and VA. The group intends to have private meetings every other week through the end of the year. A second public meeting is scheduled for Nov. 20.

Qualifying criteria should be easily verifiable and dichotomous, whenever possible, AHRQ said. Trial investigators who self-certify that they are eligible should be able to respond to criteria with simple, objective yes-or-no responses.

AHRQ has already provided possible suggestions for qualifying criteria. Investigators should indicate whether an investigational review board or federal agency has approved the trial, whether the trial has a written protocol and whether the trial has received funding or been reviewed by any external, non-federal group, AHRQ said.