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Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

Massachusetts Public Health Council Approves Regulations Implementing Relaxation of Strict Ban on Gifts from Pharmaceutical and...

On November 21, 2012, the Massachusetts Public Health Council (PHC) approved the final regulatory amendments implementing the Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N, which was amended by Gov....more

Massachusetts Relaxes Strict Ban on Gifts from Pharmaceutical and Medical Device Manufacturers to Physicians

Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The...more

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