TMA maintained that expanding the scope of podiatry requires legislators to amend the state law governing the podi- atric medical treatment and diagnosis of diseases and disorders of the foot.
OIG: Audits, legal actions may net $3.4B
The Office of Inspector of General (OIG) within the U.S. Department of Health & Human Services (HHS) announced $3.4 billion in new expected recoveries relat- ed to its investigations, audits, and other reviews, mainly of Medicare and Med- icaid. The agency made the announce- ment in connection with presenting OIG’s Semiannual Report to Congress for October 2010 through March 2011. These expected recoveries are largely made up of restitutions, fines, penalties, other assessments, and settlements. The expected recoveries include $222 million from audits and $3.2 billion from 349 criminal and 197 civil actions concluded during the period. OIG also excluded 883 individuals and entities from partici- pating in federal health care programs during the same period. OIG’s Semiannual Report to Congress highlighted the arrest of more than 100 suspects in nine cities in a health care fraud takedown. The February arrests included physicians, nurses, health care company owners and executives, and others, for their alleged participation in Medicare fraud schemes involving more than $225 million in false billing. The defendants are accused of vari- ous health care-related crimes such as violating the antikickback statute, mon- ey laundering, and aggravated identity theft. OIG collaborated with the Depart- ment of Justice, the Centers for Medi- care & Medicaid Services, state Medicaid Fraud Control Units, other federal OIGs, state agencies, and local enforcement entities.
The semiannual report also boasted
OIG’s February launch of its provider compliance training, new physician guid- ance, and fugitives list to help prevent health care fraud and improve compli-
50 TEXAS MEDICINE October 2011
ance. The compliance training sessions in cities across the United States are free for medical professionals, compliance professionals, and attorneys. Representatives from OIG, the De- partment of Justice, the Centers for Medicare & Medicaid Services, and state Medicaid Fraud Control Units conduct the training events. Also, OIG published antifraud guidance to new physicians called A Roadmap for New Physicians,
www.oig.hhs.gov/compliance/physician- education/
index.asp, and a Most Wanted Fugitives list,
www.oig.hhs.gov/fraud/ fugitives/
index.asp, which led to the capture of four individuals. To view OIG’s full semiannual report to Congress, visit
www.oig.hhs.gov/ reports-and-publications/semiannual/
index.asp.
policy development seeks to improve the presentation of this information so it is easier for consumers to read and understand.”
Print ads for prescription drugs are often at least two pages long. The first page of the prescription drug ad may feature a picture, information about the product’s intended use, and important information about the product’s risks. The second page summarizes all of the product’s risks and may be presented as densely packed text information. In the first study, a serious risk was
added to the first and second pages of the ad. In the second study, more infor- mation about side effects was included on the second page. The third study test- ed four different brief summary formats:
1. Traditional (block text paragraphs), 2. Question and answer (with headings framed in the form of questions),
FDA examines consumer understanding of drug ads
Three studies conducted by the U.S. Food and Drug Administration (FDA) confirm that the way information is con- veyed and displayed in printed drug ad- vertising affects consumer understand- ing of prescription medications. The studies examined ways to im-
prove understanding of how consum- ers use the “brief summary” section of printed prescription drug ads. The Federal Food, Drug, and Cosmet-
ic Act requires print advertisements for prescription drugs and biological prod- ucts to provide a true statement of infor- mation in summary about the advertised product’s side effects, contraindications, and effectiveness. “Some of the current approaches to fulfilling the brief summary require- ment, while adequate from a regulatory perspective, are not optimal in commu- nicating this important information to consumers,” said Thomas Abrams, di- rector of DDMAC. “FDA’s research and
3. Highlights (based on the highlights section of the physician labeling), and
4 Prescription drug facts box (resem- bling the current-over-the-counter drug facts label).
Key findings of the studies include:
• Adding a serious risk did not hinder people’s understanding of the risk in- formation.
• Including additional information about how often side effects occur and how long they may last did not hinder people’s understanding of the risk information.
• Participants who viewed the drug facts format were better able to recall risks than those who saw the tradi- tional format.
A copy of “Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Ad- vertisements for Prescription Drugs” is available in the September/October 2011 issue of Medical Decision Making,
http://mdm.sagepub.com. n
Crystal Conde is associate editor of Texas Medicine. You can reach her by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by email at
crystal.conde@
texmed.org.
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