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Pacira’s Settlement with the FDA Demonstrates the Potential for Minimizing Restrictions on Off-Label Drug Marketing

On December 15, 2015, Pacira Pharmaceuticals Inc. (PCRX), a major player in the drug industry, announced that the US Food & Drug Administration (FDA) had withdrawn its accusations that the company had engaged in unlawful "off-label" promotion of its non-opioid pain drug, Exparel, by promoting the drug for uses other than two particular uses studied in PCRX's clinical trials. Touted by many as a groundbreaking settlement for the pharmaceutical industry...

CMS Final Rule Implements the 60 Day “Report and Return” Rule on Overpayments for Medicare Parts A and B

On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published its Final Rule (the "Final Rule") obligating Medicare providers and suppliers under Parts A and B to report and return Medicare overpayments within 60 days of the identification of such overpayments. The release of the Final Rule marks a significant development for healthcare providers as CMS finally provides some clarity on the obligation to report and return...

OptumRx’s Acquisition of AxcelaCare Marks the First Strategic PBM Entrance into the Home Infusion Services Market

On November 17, 2015, OptumRx, a major Pharmacy Benefit Manager (PBM) owned by UnitedHealth Group, announced its purchase of a home infusion services provider, giving the PBM a window into the home infusion market. OptumRx will now provide its aging subscriber population with access to new and additional medications and enhance its ability to deliver care to patients requiring at-home infusions. This is a clear compliment to OptumRx's existing and...

Chronic Care Management: Revenue for Physicians, Improved Care for Patients

Chronic Care Management reduces the total cost of care for chronic disease patients while improving their overall health. In the 2015 Medicare Physician Fee Schedule Final Rule, the Centers for Medicare & Medicaid Services ("Medicare") acknowledged a provider's ability to engage in non-traditional methods of assessing patients for chronic pain, effectively opening the door to payments for chronic care management (CCM). CCM services are non-face-to-face medical care services that can...

Medicare Benefit Policy Manual Updated to Permit Payment for Physical Therapy, Nursing Care and Other Services

In January 2014, the Center for Medicare & Medicaid Services (CMS) updated its Medicare Benefit Policy Manual (“Policy Manual”) to reflect a change whereby Medicare will now compensate Medicare beneficiaries for certain skilled care, including physical therapy, nursing care, and other such services, without taking into account the patient’s likelihood of improvement or prognosis of a chronic disease. The clarification in policy will affect care provided by skilled care professionals...