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The Office of the Medicare Inspector General Issues Advisory Opinion on a “Per-Fill” Arrangement Between a Specialty Pharmacy and a Local Pharmacy

On August 15, 2014, the Office of the Inspector General (OIG) published an advisory opinion (the “Advisory Opinion”) related to a Specialty Pharmacy paying local pharmacies on a “Per-Fill” basis for “Support Services” provided by the local pharmacy. The request for the Advisory Opinion was submitted by the Specialty Pharmacy. The Specialty Pharmacy proposed the following arrangement (the “Proposed Arrangement”): local pharmacy receives a prescription for specialty drugs that Local...

Massachusetts Bill Creates New Challenges for Compounding Pharmacies

Massachusetts law makers approved a bill giving regulators unprecedented oversight of the drug compounding industry and creating new obligations for drug compounders doing business in the State. The legislation establishes four new categories of licenses (a retail sterile compounding pharmacy license, a retail complex non-sterile pharmacy compounding license, an institutional sterile compounding license, and a nonresident pharmacy license) and imposes new reporting obligations and required quality assurance measures. This bill...

Ensure Your Use of Pre-Printed Prescription Pads is Compliant

Recently, more and more pharmacies are making use of pre-printed prescription pads, which they provide to physicians’ offices as a guide for common-prescribed compounded formulations. However, in utilizing these pre-printed forms, pharmacies must be careful not to run afoul of State and Federal laws and regulations, as well the PBM manuals. First, pre-printed pads must comply with State law in the States where the prescription is written, filled and dispensed....

Upward Market Trends Foreshadow Shift in PBM Practices

On May 2, 2014, CVS Caremark Corp. (“Caremark”) announced that its first-quarter profit jumped 18%, which it attributed to its business growth in specialty pharmacy business. Revenue grew 6.3% to $32.69 billion, significantly exceeding estimates of outside analysts. The increase in the profitability of its pharmacy services business comes at a time when Caremark has increased its credentialing requirements for participating pharmacies, making it more difficult for independent pharmacies to...

Michigan Imposing Tighter Regulatory Controls on Compounding Pharmacies

On April 24, 2014, the Michigan Senate Health Policy Committee held its first hearing on Senate Bills 704 and 904, a pair of proposed legislation which will impose additional regulatory controls on compounding pharmacies. The bills, which were introduced and sponsored by State Senator Joe Hune (R-22 Dist.), impose additional compliance requirements on compounding pharmacies and elevate criminal penalties for particular violations. Bill 704 imposes several new administrative requirements, including...