Articles and Blogs

Overview and Executive Summary On Wednesday, June 17, 2015, the Department of Health Resources and Services Administration (“HRSA”) released an important 340B Drug Discount Program (“340B Program”) proposed rule (“Proposed Rule”) that, if finalized, would result in the first formal regulations governing the 340B Program. Prior 340B Program regulations related to orphan drugs were finalized... READ MORE

Overview Recently, the Department of Health & Human Services Office of the Inspector General (“OIG”) issued Advisory Opinion 15-06 addressing a 501(c)(3) charitable organization’s proposed arrangement to provide financial assistance to individuals with certain chronic diseases.  Using donated funds, the organization would assist qualifying individuals with health insurance costs, drug/device therapy costs and other... READ MORE

Executive Summary On June 9, 2015, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Fraud Alert (the “Alert”) warning that physicians can face significant liability for entering into compensation arrangements that potentially violate the Federal Anti-Kickback Statute (“AKS”).  Specifically, OIG noted that physicians entering compensation arrangements,... READ MORE

On June 4, 2015, CMS released for public inspection a final rule that makes significant changes to the regulations governing Medicare Shared Savings Program (“MSSP”) ACOs.  The rule, scheduled to be officially published in the Federal Register on June 9, revises numerous functions related to MSSP ACOs and their operations and codifies previous CMS... READ MORE

Health care providers and practitioners in most states are well aware that most Medicaid and CHIP enrollees are members of managed care organizations (“MCOs”). As states have increasingly contracted with and relied on MCOs for their growing Medicaid and CHIP populations, including enrollees who need and use long-term care services, the Centers for Medicare... READ MORE

Executive Summary On May 28, 2015, the Office of the Inspector General (“OIG”) published a mid-year update to its Fiscal Year (“FY”) 2015 Work Plan (“Updated Plan”).  The Updated Plan identifies certain new projects that OIG started since, and that did not appear in, the original FY 2015 Work Plan published in October 2014.  OIG... READ MORE

On May 19, 2015, the Subcommittee on Health of the House of Representatives Committee on Ways and Means, chaired by Kevin Brady (R-TX), held a hearing titled Improving Competition in Medicare: Removing Moratoria and Expanding Access. The hearing was the first in a series for the summer that is intended to identify solutions to... READ MORE

On April 27, 2015, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that it entered into a settlement with a Colorado pharmacy (“Pharmacy”) arising from alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule.  Under the settlement, the Pharmacy agreed to pay $125,000 in... READ MORE

On April 20, 2015, the Office of Inspector General (“OIG”), in collaboration with the American Health Law Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association, released Practical Guidance for Health Care Governing Boards on Compliance Oversight (the “Board Guidance”). The Board Guidance offers practical tips for governing boards of... READ MORE

Facts of an Interesting Telemedicine Case1 The plaintiff in the case (“Physician”) is a board-certified radiologist who entered into a contract with defendant teleradiology company (“Company”) to furnish teleradiology services to hospitals, including a hospital on Long Island, New York (“Hospital”).  Under the terms of the contract, Hospital would electronically transmit diagnostic images, such as X-rays,... READ MORE