CHA Comments on Proposed Changes to 340B ADR Process
CHA has submitted comments on the proposed rule updating the 340B administrative dispute resolution (ADR) process. In the letter, CHA generally supported the proposed rule from the Health Resources and Services Administration. CHA offered specific comments on the revised ADR panel role, structure, and the elimination of the minimum threshold of the disputed claims.
FDA Offers Guidance to Help Increase Supply of Certain Ibuprofen Products
The Food and Drug Administration (FDA) has issued guidance, effective immediately, on compounding certain ibuprofen oral suspension products in the wake of record high demand for the product.
340B Case Remanded to HHS to Determine Underpayment Remedy
On Jan. 10, the U. S. District Court for the District of Columbia sent a case about 340B underpayments back to the Department of Health and Human Services (HHS).
CHA Issues Summary of Proposed Changes to 340B Administrative Dispute Resolution Process
CHA has issued a detailed summary of the proposed rule updating the 340B administrative dispute resolution (ADR) process.
HRSA Issues Long-Awaited Proposed Rule on Administrative Dispute Resolution Process
The Health Resources and Services Administration has issued a long-awaited proposed rule updating the 340B administrative dispute resolution (ADR) process.
FDA Issues Guidance for Compounding of Amoxicillin to Alleviate Shortages
Due to increased demand, the U.S. Food and Drug Administration (FDA) has added amoxicillin oral powder for suspension to the drug shortage list and has issued guidance — in effect immediately — on its compounding.
DHCS Delays First Wave of Medi-Cal Rx Prior Authorization Reinstatement to Sept. 16
On July 26, the California Department of Health Care Services (DHCS) and its Medi-Cal Rx contractor Magellan announced a delay in the first wave of reinstatement of prior authorizations for new start medications in 11 therapeutic drug classes from late August to Sept. 16.
Reminder: Reinstatement of Medi-Cal Rx Pharmacy Claim Edits Goes Live July 22
As previously announced in CHA News, the California Department of Health Care Services (DHCS) and its Medi-Cal Rx contractor Magellan will reinstate pharmacy claim edits and Reject Code 88 for diagnosis and drug utilization review requirements on July 22.
Order Waives Restrictions on Pharmacists Independently Initiating and Furnishing Paxlovid to Individual Patients
On July 6, the Food and Drug Administration amended the Emergency Use Authorization (EUA) for Paxlovid, an orally administered COVID-19 therapeutic drug. The amended EUA expressly permits licensed pharmacists to independently order Paxlovid for individual patients under certain conditions.
Deadline for Providers to Return Electronic Claims Agreements for Medi-Cal Rx Is July 31
On June 30, the Department of Health Care Services announced an extension and reminder to all participating Medi-Cal Rx providers and billers to submit their completed Medi-Cal Rx Telecommunications Provider and Biller Application/Agreement Form by July 31. If a provider’s form is not received by July 31, they will NOT be able to continue to […]