Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

HCFA's DRUG UTILIZATION REVIEW COULD INCLUDE PRESCRIPTION DRUG REGIMEN DATA AT PHARMACY LEVEL AFTER CLAIMS PROCESSING SYSTEM IS IMPLEMENTED -- HHS' KUSSEROW

Executive Summary

The Medicare Catastrophic Care Act requirement for a drug utilization review (DUR) system could be delayed until after an electronic claims processing system is in operation, Health and Human Services Department Inspector General Richard Kusserow suggested at an April 19 House Select Aging/Human Services Subcommittee hearing on drug misuse in the elderly. Kusserow suggested that the Health Care Financing Administration might approach the DUR program "as a two-phase effort." The "first phase is to get the payment system on line," he said. "But what I would not like to see are decisions being made in the first phase that would preclude going to the second phase, which would be a much more comprehensive, more of a review, system." The Catastrophic Care Act directs HCFA to implement a DUR system by Jan. 1, 1991. The system is currently being designed to track prescription claims by Medicare under the catastrophic law. The HHS inspector general recommended that if Congress wants the DUR program to do more than track claims, it might reconsider the Jan. 1, 1991 deadline for implementation in order to allow for the development of a comprehensive DUR system aimed at reducing the level of mismedication in the elderly. Kusserow acknowledged HCFA's concern that adding features to the payment tracking system may delay its congressionally-mandated implementation date. He maintained his conviction that quality of care features should be added to the system, but suggested that such features be added later. "If indeed, [HCFA] must reach this deadline, and if they feel they cannot meet this deadline if they put all these whistles and bells on it that will deal with mismedication problems, I think at least what they should do is design a system that will allow it to adapt the second phase" later, Kusserow said. A draft of an Inspector General report on DUR, issued in January, recommended that mismedication issues be addressed in the system as it will be implemented in 1991. The final report is due imminently. It is likely to reflect Kusserow's modified thinking on the initial breadth of the system. Kusserow recommended that the second phase could involve "providing pharmacists with detailed information . . . on the drug regimen of the patient." He said that "this information will assist pharmacists in providing better drug counseling" and help to avoid "mismedication" problems among the elderly. Kusserow maintains that the DUR program provides HCFA with a valuable opportunity to improve quality of care among the elderly. Asked by Rep. Snowe (R-Maine) whether two years provides enough time for HCFA to develop a "comprehensive" DUR system, Kusserow answered: "I think it's extremely optimistic." He said that "the Health Care Financing Administration is trying its hardest to meet that deadline. I think in fact Congress may want to review that and decide if it wants to hold a hard and fast deadline to that. But before we can do that, I think that Congress really has to tell the Health Care Financing Administration very clearly and specifically, and without ambiguity, exactly what it expects out of" the DUR program. The American Pharmaceutical Association recommended at the hearing that HCFA undertake demonstration projects to test the "feasibility" of adding clinical information capabilities to the point-of-sale system. The association emphasized that such a project should be undertaken "only after [the system] has become fully operational in its primary purpose of data submission and claims processing." APhA Professional Affairs Director Edwin Webb told the subcommittee that "based on information obtained to date in meetings with HCFA staff, APhA questions the ability of the [point-of-sale] system being planned by HCFA to function as a clinical data resource for pharmacists without extensive testing." He added the association "contends that it will have insufficient operating capacity, speed and technical and professional sophistication to support the kind of comprehensive [drug utilization evaluation] called for in the [Inspector General's] draft report." Rep. Downey (D-N.Y.), who chairs the subcommittee, told Kusserow he would "transmit what you've said to Congressman Stark" (D-Calif.), who has jurisdiction over the issue as chairman of the Ways & Means/Health Subcommittee. Downey is also a member of Ways & Means.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS015467

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel