News in Brief: Week of April 29-May 3

May 01, 2013 05:25 pm News Staff

This roundup includes the following news briefs:

[News in Brief]

Ezogabine Linked to Retinal Abnormalities, Skin Discoloration

The FDA has issued a drug safety warning(www.fda.gov) indicating that the antiseizure medication ezogabine (Potiga) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. The FDA said in the release that it currently does not know if these changes are reversible, and it is working with the manufacturer to gather and evaluate all available information to better understand these events.

The FDA recommends that all patients taking the drug should have a baseline eye exam and periodic eye exams. Patients should not stop taking the drug without talking to their physician or other health care professional first.

The skin discoloration in the reported cases, which generally occurred after four years of treatment with ezogabine, appeared predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs also has been reported. Scleral and conjunctival discoloration on the white of the eye and inside eyelids has been observed, as well. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.

Adverse effects that may be related to use of this drug can be reported via RxEvent(www.rxevent.org), an adverse drug event reporting service that has partnered with the AAFP, or MedWatch(www.accessdata.fda.gov), the FDA's Safety information and Adverse Event Reporting Program.

Hospira Distributor Recalling Injectable Combination Antibiotic

According to an FDA news release(www.fda.gov), a voluntary nationwide recall has been issued for 15 lots of the combination antibiotic piperacillin and tazobactam for injection by distributor Apotex Corp. on behalf of the medication's manufacturer, Hospira Inc. The affected lots of the antibiotic may show precipitation/crystallization in the IV bag or IV line after reconstitution.

According to the release, Hospira has not received any reports of adverse events related to this recall, but the company has indicated that administration of the combination antibiotic in an IV bag or IV line may result in local reactions, such as phlebitis, as well as renal impairment, end-organ embolism and ischemia, and vasculitis. In addition, precipitation of the drug may not allow delivery of the needed therapeutic dose, resulting in inadequate treatment of the targeted infection.

The affected lot numbers can be found in the FDA release. Anyone with an existing inventory of the product should stop use and distribution, quarantine the recalled lots immediately, and call GENCO at (877) 674-2078 between the hours of 7 a.m. and 5 p.m. CDT, Monday through Friday, to arrange for product return.

Adverse effects that may be related to use of this product can be reported via RxEvent(www.rxevent.org), an adverse drug event reporting service that has partnered with the AAFP, or MedWatch(www.accessdata.fda.gov), the FDA's Safety information and Adverse Event Reporting Program.

Proposed Rule Would Greatly Increase Rewards to Medicare Fraud Tipsters

HHS recently announced a proposed rule that would significantly increase the amount of rewards given to individuals who provide tips about suspected Medicare fraud when those tips lead to the successful recovery of money.

According to details provided in a CMS fact sheet(www.cms.gov), a tipster would be eligible to receive a reward of 15 percent of the amount recovered. Moreover, CMS proposes to raise the maximum amount on which the agency will base incentive payments to the first $66 million recovered. Thus, an individual could potentially get a government check for as much as $9.9 million if CMS recovered $66 million or more.

The current program offers a reward of 10 percent of monies recovered and caps awards at $1,000.

According to an April 24 press release(www.hhs.gov), the same proposal would strengthen some physician enrollment measures that, in effect, would deny Medicare enrollment to physicians or other health care professionals who have unpaid Medicare debt. The rule also would deny or revoke billing privileges for anyone with a felony conviction and would revoke privileges for physicians and other health care providers and suppliers who abuse those privileges.

CMS Streamlines Applications for Health Insurance Marketplaces

CMS simplified and significantly shortened the application for health care coverage that will be provided as part of the health insurance marketplaces that are scheduled to be up and operating by Jan. 1 of next year.

The agency shortened the application for individuals without health insurance from 21 pages to three pages and reduced the application for families seeking insurance through the marketplaces by two-thirds. In a recent press release(www.cms.gov), CMS describes the shortened forms as "consumer friendly," saying they are "much shorter than industry standards for health insurance today."

Enrollment for the marketplaces starts on Oct. 1, and consumers can apply online, by phone or by filling out a paper application.


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