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
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
• 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
11/15/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Section 340B ,
Vendors
Enforcement -
OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals -
On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more
3/27/2017
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Free Health-Related Services ,
Health Care Providers ,
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Hospital Mergers ,
Hospitals ,
Market Allocation Scheme ,
Medicare Part D ,
OIG ,
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Safe Harbors ,
Sherman Act ,
Unfair or Deceptive Trade Practices ,
Value-Based Purchasing
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
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
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