Health Care

On July 16, 2013, the U.S. Department of Justice  (DOJ) indicted Michael Baker and Michael Gluk, the former CEO and CFO, respectively, of ArthroCare Corp. – a Texas-based publicly traded surgical device company. 

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers of value. 

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for calendar year 2014. The rule proposes several changes that, if finalized, would have grave consequences for independent laboratories. 

This week, CMS announced the shared savings results and the clinical achievements from the first year of the Pioneer ACO Program.

The LA Times recently reported the firing of six workers at Cedars-Sinai Medical Center in connection with the unauthorized access to patient medical records. 

Individuals or entities who voluntarily disclose potential fraud to the Office of Inspector General for the Department of Health and Human Services (the OIG) under the Provider Self-Disclosure Protocol (SDP) may now submit their disclosure online using the OIG’s newly released Self-Disclosure Online Form. 

Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. 

This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential "economic crimes."

Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the "Requestor") tiered rebate program (the "Proposed Arrangement").

The New York State Attorney General (AG) has teamed up with lawmakers to introduce two new bills that propose an overhaul of the Not-for-Profit Corporation Law (N-PCL), which has not seen significant change in more than 40 years.

CMS hosted a webinar yesterday focusing on best practices for Medicare Advantage and Prescription Drug Plan Sponsors looking to enhance their Star Ratings.

The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation. 

The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services (CMS) illustrates.The Council for Urological Interests, a nonprofit association of physician-owned lithotripsy joint ventures, sought to overturn a 2008 CMS regulatory change to the Stark Law that made the urologists’ joint ventures illegal.

On May 24 the District Court for the District of Columbia rejected an appeal brought by a group of urologists (“CUI”) seeking to overturn regulations promulgated in 2008 by the Centers for Medicare & Medicaid Services (“CMS”) that prohibited physician-owned “under arrangement” service providers under the Stark Law (the “2008 Rule”).

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. 

To incentivize whistleblowers to bring false claims promptly to the government’s attention, the False Claims Act (FCA) includes a so-called “first-to-file rule" (31 U.S.C § 3730(b)(5)), which bars a person other than the government from “bring[ing] a related action based on the facts underlying” a pending action alleging violation of the FCA.

As health information technology (HIT) advancements proliferate, so too must governing regulations. 

Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in the Federal Register on May 17. This final rule reverses previous regulations that prohibited MFCUs from using federal matching funds for data mining.

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required.