Articles and Blogs

Executive Summary On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule addressing many potential modifications to the Stark Law (“Proposed Rule”),1 as well as separate guidance for physician-owned hospitals relating to the required Annual Ownership/Investment Report (“Reporting Guidance”).2  The Proposed Rule, if implemented as currently proposed, would update... READ MORE

Overview On July 8, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule pertaining to payment policies under the Physician Fee Schedule for CY 2016 (“Proposed Rule”).1 In addition to changes to the Physician Fee Schedule and other Medicare Part B payment policies, the Proposed Rule addresses modifications to the Stark... READ MORE

Overview On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule pertaining to payment policies under the Physician Fee Schedule for CY 2016 (“Proposed Rule”).1  In addition to changes to the Physician Fee Schedule and other Medicare Part B payment policies, the Proposed Rule also addressed many potential... READ MORE

Executive Summary On June 30, 2015, the Food and Drug Administration (“FDA”) issued draft guidance delaying the enforcement of key track and trace requirements of the Drug Supply Chain Security Act (“DSCSA”) for Dispensers1 until November 1, 2015 (“Guidance”).  Specifically, the FDA indicated that it does not intend to take action against Dispensers that... READ MORE

Under the final Code Section 501(r) regulations, as published in December 2014, a hospital facility’s financial assistance policy (“FAP”) must include a list of all providers of emergency and medically necessary care in the facility and must identify which are and are not covered by the FAP. In the newly published Notice 2015-46 (“Notice”), the... READ MORE

In an eagerly awaited, mightily impactful health care decision, King v. Burwell (U.S. No. 14-114 June 25, 2015), the Supreme Court of the United States (the “Supreme Court”) held that individuals eligible for tax credits to subsidize their purchase of health insurance in health care marketplaces created by the Affordable Care Act (“ACA”) may... READ MORE

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