Entries by Eric Hartkopf, PharmD

OIG Semiannual Report to Congress Shows 11:1 Return On Investment

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently released its Semiannual Report to Congress summarizing program integrity efforts from October 2024 through March 2025 which showed a return of $11 for every $1 spent. The OIG is the lead federal agency combating healthcare fraud, waste, and abuse in federal […]

NCPDP Package Size Updates: Gonal-f® RFF Redi-ject® and Teriparatide (Alvogen)

Similar to the recent package size changes for Forteo®, NCPDP reports that the FDA has requested product labeling changes on four additional products which will be revised in compendia this summer. The FDA is not requiring manufacturers to obtain new NDCs and there are no clinical changes to the products. Products with coming package size […]

Medicare Prescription Drug Coverage and Your Rights (CMS-10147)

When a pharmacy receives an NCPDP Reject Code 569 <Provide Notice: Medicare Prescription Drug Coverage and Your Rights> on a Medicare Part D claim, the pharmacy “must” provide the patient with the CMS-10147 form, also known as the Medicare Prescription Drug Coverage and Your Rights notice. The notice instructs enrollees about their right to contact their […]

Eye Drop Guidance Updates: Prime Therapeutics

Prime Therapeutics acquired Magellan Rx in 2022 and released the first “integrated” Provider Manual for network pharmacies in January 2024. An important change in the revised Provider Manual is the guidance for billing eye drop medications, which carries billing and audit implications.

Electronic Prescriptions: Upcoming Changes to Quantity and Unit of Measure

The National Council for Prescription Drug Programs (NCPDP) is a not-for-profit organization that develops and promotes standards for the exchange of information within the pharmacy services space. This organization develops the e-prescribing SCRIPT standard as well as the pharmacy billed D.0 standard (among other things).

USP 800 Compliance Program Updates: NIOSH 2024 List

USP 800 outlines the standards for healthcare providers that handle hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH). Pharmacies that handle hazardous drugs (including carbamazepine, clonazepam, colchicine, and cyclosporine …

FDA Approves First Rapid-Acting Insulin Biosimilar: MerilogTM (insulin aspart-szjj)

On February 14, 2025, the FDA approved the first rapid-acting insulin biosimilar, MerilogTM (insulin aspart-szjj) manufactured by Sanofi Aventis. MerilogTM is expected to reach the U.S. market in July 2025 and will require prescriber approval before pharmacies can substitute for other insulin aspart products such as Fiasp® or NovoLog®. MerilogTM is the third insulin biosimilar […]

Diabetic Test Strip Authorized Distributors – LifeScan Audits Continue!

Independent pharmacies continue to receive letters regarding the purchase of OneTouch® test strips, manufactured by LifeScan. We have seen two variations of these letters – one “warning” letter from LifeScan directly and a second letter demanding repayment for invoice shortages from a law firm acting on LifeScan’s behalf. Both letters contend that pharmacies submitted more […]

Template Forms Can Lead to Audit Problems

At a time when the workday seems to be growing ever more hectic, prescribers and pharmacies may find pre-printed prescription forms convenient; especially for medications which are frequently utilized by a prescriber for treatment. Unfortunately, many PBMs prohibit pre-printed prescription form use for various reasons.

Caremark Aberrant Practices and Trends – Enforcement Extends Beyond the Aberrant Product List

PAAS National®® analysts have worked with numerous pharmacies who have received communications related to Caremark’s proprietary Aberrant Product List or other alleged Atypical Dispensing Patterns. These letters are driven by Caremark’s Provider Manual section 3.02.03 which was expanded in 2022 as discussed in the Newsline article, Caremark® Expands “Aberrant” Language & Restricts Bulk Purchases. These letters fall into two different categories: