PHARMACY

Utah passes Pharmacy Audit Integrity and Recovery Act

BY Allison Cerra

ALEXANDRIA, Va. — Legislation designed to reform the pharmacy audit process has been approved in Utah and will be sent to the state governor to sign.

In a 73-1 vote, H.B. 76, known as the Pharmacy Audit Integrity and Recovery Act, "requires health benefit plans, the Public Employees’ Benefits and Insurance Program and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims," according to the legislation document. Key provisions included:

  • Clerical or recordkeeping error, such as a typo, should not be considered fraud or subject to recoupment or criminal penalties;

  • Findings of overpayment or underpayment must be based on actual overpayment or underpayment and not a projection;

  • Audits cannot recoup dispensing fees from the pharmacy;

  • An auditing entity may not be paid based on a percentage of the amount recovered;

  • All pharmacies are to be audited under the same standards or parameters as other pharmacies;

  • The period covered by the audit may not exceed 18 months, unless superseded by federal law; and

  • Audits have a 200 script maximum limit.

The bill’s chief sponsor was Rep. Evan Vickers (R-Utah), who is a pharmacist and a member of the National Community Pharmacists Association.

"This legislation is an important step forward for patients and pharmacists across Utah," NCPA CEO Douglas Hoey said. "Fair auditing of pharmacies is a legitimate way to protect public and private health plans from waste, fraud and abuse. However, recently pharmacy auditing practices are sapping pharmacists’ time to counsel patients and appear to be more about generating revenue for the middleman than rooting out fraud. There’s no reason for community pharmacists to routinely lose time and thousands of dollars in audits when the right medication is dispensed to the right patient at the right time. We commend state representative, pharmacist and NCPA member Evan Vickers, the Independent Pharmacy Cooperative and the Utah Pharmacists Association for making it happen. NCPA was proud to support their grassroots efforts."

The passage of the Pharmacy Audit Integrity and Recovery Act also was praised by the National Association of Chain Drug Stores.

"The passage of this legislation is an important step in curbing questionable tactics used by PBMs that only seek to hurt patients and increase already-skyrocketing healthcare costs," NACDS president and CEO Steve Anderson said. "The lack of transparency by PBMs in the audit process has penalized community pharmacy and more importantly, posed challenges to patients including increased drug costs. We thank Rep. Vickers for his leadership in passing this bill, as well as the efforts of the Utah Retail Merchants Association and the Utah Food Industry Association in achieving this legislative victory."


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PHARMACY

Endo seeks tougher standards for generic versions of Lidoderm

BY Alaric DeArment

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

The drug maker added an amendment to a citizen petition it filed with the FDA in 2006 concerning the drug Lidoderm (lidocaine), a patch used to treat post-herpetic neuralgia, a painful condition associated with shingles. The drug maker said the amended petition "highlights the growing scientific and regulatory support" for requiring clinical studies from generic drug makers looking to gain FDA approval for generic versions of such locally acting topical drugs as Lidoderm.

"Since we filed the original citizen petition in 2006, new studies and opinions from research scientists, as well as public statements from FDA officials, have further validated the need for comparative clinical endpoint studies to ensure a locally acting topical medication is bioequivalent to the branded product," Endo chief scientific officer and EVP research and development Ivan Gergel said. "FDA must publicly address the many unanswered questions from the original petition, as well as the additional concerns raised in this amendment, before taking any formal steps toward the approval of a generic version of Lidoderm."

Specifically, Endo said pharmacokinetic studies, which measure the level of a drug in the bloodstream, are not enough to demonstrate that a generic version of Lidoderm would be equivalent to the branded drug. The company also said that scientists had not identified any method other than clinical endpoint studies to show that drugs like Lidoderm and generic versions are equivalent and asked the agency to address allegations by another drug maker that the FDA had answered Endo’s 2006 petition in private correspondence, which Endo said would be illegal if it’s true.


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HRG to present pharmacy design, OTC merchandising layout lecture at Campbell University

BY Allison Cerra

WAUKESHA, Wis. — Hamacher Resource Group announced that Tom Boyer, national account manager and co-owner at HRG, will be speaking to students in the pharmacy practice program at Campbell University this month.

Boyer, an 18-year veteran of the retail consumer healthcare industry, will present pharmacy layout, design, and over-the-counter merchandising to the program’s first-year students. The presentation is designed to help guide young pharmacists in operating a profitable front-end, and focuses on how to build customer loyalty and satisfaction as well as create an overall enjoyable shopping experience.

"We help pharmacists best serve their patients as well as run a profitable business," HRG VP Dave Wendland said. "Getting the front-end of the pharmacy right pays off in many ways and Tom does a great job of outlining the principles to give the students a real-life understanding of merchandising and store layout. It’s gratifying to hear that the students find it so valuable."


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