340B and Telehealth/HHS Waivers
The COVID-19 pandemic has created an increased need for the use of telehealth services. Powers has received several questions from Ryan White clinics about whether a prescription for a patient…
HRSA to Collect Information on Manufacturer Audit Process
On June 18, 2019, HRSA issued an information collection request (ICR) regarding the guidelines for manufacturer audits of 340B covered entities and the OPA informal dispute resolution process to resolve…
Guidance on Purchase of Mobile Vans with Program Income
You will probably recall that Powers asked the HRSA HIV/HIV/AIDS Bureau (HAB) for guidance recently on whether Ryan White program income may be used to purchase mobile vans to be…
California Medicaid Will Transition All Pharmacy Services to Fee-for-Service
On January 7, California Gov. Gavin Newsom signed an executive order instructing Medi-Cal to transition all pharmacy services for Medi-Cal managed care to fee-for-service (FFS) by January 2021. The directive…
OPA Describes Best Practices for Resolving Contract Pharmacy Non-Compliance
OPA recently posted a program update entitled “Best Practices for Covered Entities: Resolving Contract Pharmacy Related Non-Compliance.” In the update, OPA states that it has concerns about contract pharmacies and/or…
HRSA Withdraws Proposal to Weaken CMP Rule
On April 30, 2018, the White House Office of Management and Budget (OMB) published a notice that HHS has withdrawn a proposed rule that would have amended the 340B Ceiling…
HRSA Seeks Additional Delay of CMP Rule
The 340B Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) rule may be a delayed a fifth time. On March 27, 2018, HRSA sent to the White House Office of…
RWC-340B Signs on to 340B Coalition’s Comments Opposing CMP Final Rule
RWC-340B joined the 340B Coalition in submitting comments to the Health Resources and Services Administration opposing the additional delay of the 340B Ceiling Price and Manufacturer Civil Penalties Final Rule.…
OIG Report on Track-and-Trace Law and 340B
The Department of Health and Human Services’ Office of the Inspector General (OIG) recently issued a report on drug supply chain security with implications for 340B contract pharmacies, which have…
CMS Proposes Lower Reimbursement for Medicare Part B 340B Drugs
On July 13, the Centers for Medicare and Medicaid Services, or CMS, released a proposal to reduce Medicare reimbursement for separately payable 340B drugs administered in hospitals from ASP +…