Articles and Blogs

On April 15, 2016, the Food and Drug Administration (“FDA”) issued three important draft guidance documents that clarify the standards under Sections 503A and 503B of the federal Food Drug & Cosmetic Act (“the Act”) applicable to compounding activities carried out by prescription drug compounders. These compounders include hospital pharmacies, non-hospital pharmacies (including retail pharmacies)…Read More

Secondary Payer Refunds, Overpayments and Obligations CMS’s new rule regarding the reporting and returning of Medicare overpayments (effective March 14, 2016) makes clear that secondary payer refunds owed by health care providers to Medicare may become overpayments for purposes of the new rule. Without sufficient oversight, such overpayments may expose a health care provider to liability…Read More

Executive Summary April 16, 2016 is National Healthcare Decisions Day. The goal of the day is to encourage Americans to think and talk about their health care goals and communicate their health care decisions by executing advance health care directives. Background Studies indicate that most Americans have not executed documents that name a health care…Read More

In a continuation of legal challenges to seemingly appropriate employer conduct rules, the National Labor Relations Board (“NLRB”), on April 13, 2016, issued another decision that will make employers even more nervous about the legality of their rules that are intended to assure “harmonious interactions and relationships.” Indeed, the NLRB in a 2-to-1 decision, over…Read More

Senators Call on CMS to Delay Star Ratings for Overall Hospital Quality On April 11, 60 senators sent a letter to CMS Acting Administrator Andy Slavitt urging the agency to delay the release of the overall hospital quality star ratings to provide more time to analyze the methodology of the star ratings, examine its impact…Read More

On April 11, 2016, the Centers for Medicare & Medicaid Services (“CMS”) announced a new model for the way Medicare pays many primary care physicians. The Comprehensive Primary Care Plus (“CPC+”) model aims to enhance primary care through care redesign. CPC+ will include two primary care practice tracks with incrementally advanced care delivery requirements and…Read More

CMS Begins Testing of Bundled Payment Program for Joint Replacement On April 1, CMS launched a bundled payment demonstration for inpatient knee and hip surgeries. The agency will pay nearly 800 hospitals across 67 metro areas bundled payments for joint replacement procedures, which is expected to save Medicare $343 million over the course of the…Read More

An Indiana Federal District Court just published an opinion on an issue of first impression in the Seventh Circuit, the ability of the government to reject or approve a settlement in a case in which they did not intervene. The court also opined on the ability of a whistleblower to enter into a settlement that delivered…Read More

CMS posted a notice on its website inviting stakeholders to submit questions and/or scenarios to CMS regarding implementation of the Budget Act provision impacting OPPS coverage for off-campus provider-based departments. The full notice, which can be found here, follows. Note Regarding Implementation of Section 603 of the Bipartisan Budget Act of 2015 CMS will be…Read More

On Friday, March 18, 2016, CMS released a memo entitled “Payroll-Based Journal (PBJ) – Implementation of required electronic submission of Staffing Data for Long Term Care (LTC) Facilities.” The memo reminds LTC providers that the mandatory PBJ submission period begins July 1, 2016. The memo also contains information on how to register for PBJ reporting and how…Read More