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| Federal Perspectives |
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FDA ‘MedGuide’ Rule Goes into Effect
Pharmaceutical manufacturers are busy coming up to speed with new consumer information requirements mandated under a Food and Drug Administration regulation that go into effect June 1, 1999.
The new regulation requires drug manufacturers to develop and disseminate "MedGuides" for drug products if the agency deems that a product poses a risk of serious adverse effects that could be prevented through specific usage instructions, if it poses serious risks of which patients should be aware, or if the product is "important to health" and strict adherence to usage instructions is crucial to its effectiveness.
The FDA’s final MedGuide rule, published in the December 1, 1998, Federal Register, lays out detailed requirements for standardization of MedGuide content and format. Drug makers must obtain FDA approval of each MedGuide prior to its distribution.
| PPS Savings Greater Than Expected | ||||||
| Recently revised Congressional Budget Office (CBO) estimates indicate that cost savings produced by the Medicare nursing facility prospective payment system (PPS) and other Medicare changes enacted under the Balanced Budget Act (BBA) of 1997 will total $16.6 billion over the next five years-about $7.1 billion more than originally projected.
The leading trade associations of nursing facility owners and operators, the American Health Care Association and American Association of Homes and Services for the Aging, are calling on Congress and the Clinton administration to give their members relief from tightening PPS-induced cost control pressures by restoring the $7.1 billion "surplus" to Medicare nursing facility spending. | ||||||
| 1998 | 1999 | 2000 | 2001 | 2002 | TOTAL | |
| Projected Medicare Savings over pre-BBA Spending estimates (9/97 CBO est.) | $14.0 | $14.1 | $14.6 | $15.2 | $15.9 | $73.8 |
| Projected Medicare Savings over pre-BBA Spending estimates (3/99 CBO est.) | $13.2 | $12.7 | $12.9 | $13.6 | $14.3 | $66.7 |
| Difference between 9/97 and 3/99 CBO estimates | $0.8 | $1.4 | $1.7 | $1.6 | $1.6 | $7.1 |
| Source: Congressional Budget Office. | ||||||
AHCPR Guidelines Now Accessible via Internet
Health care providers can now access the full array of clinical practice guidelines developed under the purview of the Agency for Health Care Policy and Research (AHCPR) via the World Wide Web.The new National Guidelines Clearinghouse (NGC) Web site is a comprehensive database of evidence-based practice guidelines and associated documents. Visitors to the site can view or download information including structured abstracts of each guideline, with background information on its development; syntheses of guidelines addressing similar topics; an electronic forum for exchange of information on implementation and use of the guidelines; annotated bibliographies of the guideline development methodology; and direct links to full-text versions of selected guidelines.
Recent additions to the NGC Web site include new or revised guidelines on topics such as immunization quality standards, medical management of osteoarthritis, and treatment of pressure ulcers.
The Web site (www.guideline.gov) will be maintained by AHCPR in collaboration with the American Medical Association and the American Association of Health Plans.
David K. Buerger
Senior Editor