The CDC recently revised recommendations for COVID-19 vaccination by (i) removing the recommendation for pregnant women to receive the vaccine and (ii) that individuals ages 6 months to 17 years may receive the vaccine using a shared clinical decision-making (SCDM) approach. The SCDM recommendations are meant to be flexible and informed by the characteristics, values, […]
Numerous pharmacies have received letters from AstraZeneca, the manufacturer of Farxiga® 5 and 10 mg, regarding “discrepancies” identified in a reconciliation of purchase and dispensing data from 2024.
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 […]
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 […]
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 […]
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.
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 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 …
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 […]
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 […]
