Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

MEDICARE DRUG UTILIZATION REVIEW COULD THREATEN MD-PATIENT RELATIONSHIP

Executive Summary

MEDICARE DRUG UTILIZATION REVIEW COULD THREATEN MD-PATIENT RELATIONSHIP, the Pharmaceutical Manufacturers Association cautioned in a March 2 letter to HHS Inspector General Richard Kusserow. Commenting on a recent Inspector General draft report, "Medicare Drug Utilization Review," the association suggested that efforts to cut program costs should not second-guess physicians' choice of therapies unnecessarily. Prospective DUR raises "concerns about safeguarding patient confidentiality and avoiding unnecessary interference in the patient-physician and patient-pharmacist relationships," PMA said. The program's requirement for electronic checking of every Medicare beneficiary's patient profile for possible contraindications at the point-of-sale also raises questions about feasibility, the association added. "PMA believes that the report may be overly optimistic about the capabilities of prospective DUR," the letter states. "Experts in the DUR field have raised serious questions about the ability of the point-of-sale system envisioned by HCFA ]the Health Care Financing Administration[ to accomplish prospective DUR." The Inspector General issued its report on DUR earlier this year ("The Pink Sheet" Feb. 20, p. 9). PMA is not alone in questioning the feasibility of a point-of-sale DUR system. Organized pharmacy has also raised the issue and HCFA itself acknowledges that it may be unrealistic to expect a full-scale DUR program to be up and running by the Jan. 1 1991 starting date of the drug benefit program. PMA said it "supports the DUR provisions" of the Catastrophic Care Act of 1988 and "appropriate DUR programs at the state Medicaid level." Such programs save "overall health care costs" over time by improving the quality of care, the association asserted. Correcting the "under-utilization" of pharmaceutical therapy may actually increase costs in the short term, the association said. Instead, PMA suggested, DUR programs should focus on eliminating "fraud and abuse," which can be "quite costly, are easily identifiable and may have a major impact on the Medicare program." The association said it was "particularly concerned about the report's assertion that clinical studies on new drugs for use in older people are typically performed on healthy young adults for a short period of time." Such studies make up "only the first phase of human testing -- a multiphase process that averages six years to complete," the association noted. "In subsequent phases," PMA added, "new drugs for the elderly are tested for years on large numbers of older people, because they are the people with the conditions that the drugs are intended to treat." The association also cited "FDA reports that today's NDAs contain data on an appropriate number of older people."

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

UsernamePublicRestriction

Register

OM004078

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