MCN Healthcare: Policy Management and Compliance Tools

The Federal Trade Commission has issued revised guidance designed to help businesses comply with the requirements of the Red Flags Rule,  which protects consumers by requiring businesses to watch for and respond to warning signs or "red flags" of identity theft. The guidance outlines which businesses, financial institutions and some creditors, are covered by the Rule and what is required of businesses to protect consumers from identity theft. 

If a hospital or other health care facility meets the rule's definition of a creditor the organization must have a written identity theft program in place.  The rule was revised last year to more narrowly define the types of creditors subject to the rule's requirements.  According to the revised Red Flags Rule, a creditor is covered only if, in the ordinary course of business, it regularly:

• Obtains or uses consumer reports in connection with a credit transaction;
• Furnishes information to consumer reporting agencies in connection with a credit transaction; or
• Advances funds to or on behalf of a person, in certain cases.

The Amended Rule does not exclude the health care industry from compliance.  Rather it makes compliance with the rule specific to an organization's conduct.  According the FTC the way in which an organization answers the following questions determines if compliance with the rule is required.  To determine if your business is a creditor under the Red Flags Rule, ask these questions:

• Does my business or organization regularly:

o defer payment for goods and services or bill customers?
o grant or arrange credit?
o participate in the decision to extend, renew, or set the terms of credit?

• If you answer:

o No to all, the Rule does not apply.
o Yes to one or more, ask:

• Does my business or organization regularly and in the ordinary course of business:

o get or use consumer reports in connection with a credit transaction?
o give information to credit reporting companies in connection with a credit transaction?
o advance funds to - or for - someone who must repay them, either with funds or pledged property (excluding incidental expenses in connection with the services you provide to them)?

• If you answer:

o No to all, the Rule does not apply.
o Yes to one or more, you are a creditor covered by the Rule.

Once you determine if the Ref Flags Rule is applicable to your organization use the FTC's revised How-To-Guide for Business to identify which accounts are covered.  A link to the Guide is provided below.

In the event that your organization is required to comply with the Red Flags Rule, StayAlert is including with today's notice an example of an identity theft prevention program.

The U.S. Food and Drug Administration (FDA) is informing health care professionals of a Class I Recall of Endologix, Inc.'s AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures.

The AFX Introducer System is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss. This recalled product was distributed and manufactured from April 1, 2013 through April 30, 2013 and distributed in the U.S. only in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York. Affected lot numbers include 1079840, 1079843, 1079844, 1079845.

On May 13, 2013, Endologix sent its customers an Urgent Medical Device Recall Notice letter stating "Do not use or further distribute any affected product." The firm also instructed their customers to share this information with physicians who perform these procedures at their facilities. On May 21 the firm expanded the recall by mailing a recall notification letter to an additional customer. Customers may contact the firm with questions at 1-800-983-2284.

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at the link provided below.

The U.S. Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death.

Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium

The FDA is providing this information to health care professionals while it continues its investigation. If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read the complete MedWatch Safety Alert, including a link to the Safety Communication, at the link provided below.