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

HHS CLINICAL PRACTICE GROUP CONTRACTING OUT THREE NEW GUIDELINES

Executive Summary

HHS CLINICAL PRACTICE GROUP CONTRACTING OUT THREE NEW GUIDELINES to be developed for new treatment outcomes. HHS' Agency for Health Care Policy and Research has been arranging for the development of guidelines to be used by health care professionals in determining how various health disorders best can be clinically managed. The RAND Corporation will address congestive heart failure secondary to coronary vascular disease, the American Academy of Pediatrics will develop guidelines for otitis media in children and the Center for Health Economics Research will consider post-stroke rehabilitation, AHCPR said in a Dec. 2 Federal Register notice. An AHCPR spokesperson said the principal difference between contracting out for clinical practice guidelines and developing them in-house is that the contractors will do much of the scientific literature review. In calling for the establishment of clinical practice guidelines, the Omnibus Budget Reconciliation Act of 1989 specifies that AHCPR may create the guidelines in-house or contract out their development. Previous guidelines efforts have been from within the agency. Panels comprising 10-15 "appropriately qualified experts and health care consumers" and one chairperson will be convened for each clinical practice area, the Dec. 2 notice says. Nominations for panel chairpersons and members should be sent to the appropriate contractor by Dec. 27. Contractors subsequently will submit their proposed candidates to AHCPR for approval. The role of each panel, the notice says, is to assist the contractor to: "develop a decision-making process; determine the focus of the guidelines and the questions to be addressed; advise and monitor the review and analysis of the scientific literature; consider and advise on the principal health policy issues; monitor and provide counsel on the development of medical review criteria, standards and performance measures; and review and approve the interim and final drafts." To date, clinical practice guideline panels have been convened to develop standards for treatment areas including: visual impairment due to cataracts in the aging eye; diagnosis and treatment of benign prostatic hyperplasia; urinary incontinence in adults; prediction, prevention and early treatment of pressure sores in adults; delivery of comprehensive care in sickle cell disease; pain management; and diagnosis and treatment of depressed outpatients in primary care settings. Release of guidelines on acute pain management, an internal AHCPR effort, was delayed until early 1992 to allow AHCPR time for further revisions, the third postponement of their release made by the agency ("The Pink Sheet" Dec. 2, In Brief). The guidelines on urinary incontinence and pressure sores may accompany the release of the acute pain document, the agency says. While acute pain management guidelines will focus on surgical patients, future guidelines will deal with pain management in cancer patients and the chronically ill. The contracting out of clinical practice guidelines development is part of a growing interest in innovative public/private relationships. This fall, four major insurance trade associations -- the American Managed Care and Review Association, the Blue Cross and Blue Shield Association, the Group Health Association of America and the Health Insurance Association of America -- proposed paying ACHPR $ 1 mil. to more than double the number of technology reviews conducted annually by the agency to 40. The plan has been opposed by the Health Insurance Manufacturers Association ("The Pink Sheet" Nov. 11, p. 13).

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

MT142539

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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