HEALTH

NCPA: Members left out of the FSA mix

BY Michael Johnsen

ALEXANDRIA, Va. A new Internal Revenue Service requirement intended to ensure that flexible spending account debit cards are used only for eligible purchases, has produced a wave of logistical problems for independent community pharmacies, putting them at an unfair, competitive disadvantage, the National Community Pharmacists Association announced Friday.

However, for those NCPA members who signed on for FSAok AutoCopay, a service announced by NCPA on July 8, there have been no issues, NCPA noted.

Since the IRS mandate took effect, community pharmacists who had installed an appropriate “point-of-sale” system and/or qualified for the “90%” exemption from the requirement have had transactions involving FSA debit cards consistently rejected, NCPA noted.  And calls to the Special Interest Group for IIAS Standards, a standards-setting body that oversees the new requirement, can take several business days to initially reach a representative.

As a result, community pharmacists are being told to send their patients to their larger chain competitors.

“Independent community pharmacies have been consistently and comprehensively disadvantaged in transactions of the type SIGIS was established to equitably facilitate,” NCPA EVP and CEO Bruce Roberts, wrote in a letter to SIGIS.

“We are receiving consistent complaints from our membership that SIGIS and its processes are opaque, unresponsive and lack transparency. Worse, our members consistently find that SIGIS is unresponsive and unhelpful,” he commented. “The processes and procedures being used by SIGIS appear to disadvantage small community and independent pharmacies, and in doing so, hurt their ability to compete in the marketplace with SIGIS’ large corporate members,” Roberts continued. “This is a source of grave concern to NCPA and our members.”

NCPA officials raised these concerns in a July 23 conversation with SIGIS officials and are hopeful the group will take prompt measures to alleviate some of the problems community pharmacies are experiencing.  Specifically, the NCPA letter requests the following actions:

  • Establish a dedicated independent pharmacy help-desk that is answered by a live individual during regular business hours. All inquiries received via e-mail or on after-hours voicemail should be responded to within 24 hours; 
  • SIGIS should facilitate and expedite the acquisition of merchant codes by community pharmacies within 24 hours. In addition, community pharmacies should not be classified as e-merchants or placed in a non-medical category;
  • SIGIS should notify pertinent parties when an error occurs in the application process within 24 hours for all applicant types;
  • SIGIS needs to notify pertinent parties when amendments of applications occur so that an independent pharmacy, the acquirer or other relevant party is made aware of any new information within 24 hours;
  • SIGIS should notify and make available to plan administrators and card processors the list of newly certified merchants on a daily basis;
  • SIGIS should send correspondence to all plan administrators advising them to stop directing employees/patients to particular pharmacies or pharmacy chains.

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Diagnostic Devices in contract with two states for Medicaid-covered blood glucose monitoring systems

BY Michael Johnsen

CHARLOTTE, N.C. Diagnostic Devices on Wednesday announced contracts with the states of Illinois and Missouri around Medicaid coverage of its Prodigy line of blood glucose monitoring systems and test strips.

“We will continue working with other states for coverage under their Medicaid programs, and to demonstrate to them the savings Illinois and Missouri taxpayers will realize with the Prodigy family of products,” stated Rick Admani Abulhaj, Diagnostic COO.

A recent study by University of Florida PharmD candidates found the “talking” feature of the Prodigy AutoCode meter made a “significant improvement” in overall diabetes control and compliance among patients who took part, the company noted.

The Prodigy Voice meter for blind or low-vision diabetes patients has been honored with awards from both the National Federation of the Blind and the American Foundation for the Blind, the company added.

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FDA warns consumers about body-building products that contain steroids, related substances

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Tuesday issued a Public Health Advisory warning consumers to stop using body-building products that are represented as containing steroids or steroid-like substances and oftentimes misbranded as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories for marketing and distributing body-building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body-building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories, including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body-building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” stated FDA commissioner Margaret Hamburg. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories,  include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective.  In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

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