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340B Drug Pricing Program Compliance
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Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
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Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
Introduction - Pharmacy employees at some CVS and Walgreens stores, including pharmacists, technicians, and support staff, recently walked off of their jobs to protest insufficient staffing and dangerous workloads that they...more
On October 31, 2023, the New York State Department of Financial Services (DFS) released a notice withdrawing its proposed market conduct rules for pharmacy benefit managers (PBMs). The proposed rules, announced August 16,...more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
As 2021 quickly comes to a close, we look back at this year’s legislative session, which included several employment-related bills signed by Governor Gavin Newsom, including bills aimed at prohibiting quotas that interfere...more
The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more
Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more
In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more
This is part two of a two-part series covering drug diversion In Iowa. Last week, we started with an overview of key questions and considerations when there is a drug diversion issue. ...more
CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more
Today, in a move that is widely supported by those in both political parties and across the country, President Trump declared the opioid epidemic a national emergency. Doing so will allow for additional resources to be used...more
On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more
On October 4, 2016, The Centers for Medicare and Medicaid Services (“CMS”) released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more
Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements. Florida established its Prescription Drug Monitoring...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more
FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more
Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more
On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more