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New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services
August 7, 2013 | Blog | By Karen Lovitch , Theresa Carnegie
Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office ancillary services exception (IOASE).
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ML Strategies Posts Weekly Health Care Reform Update on August 5, 2013
August 6, 2013 | Blog | By Theresa Carnegie
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.
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Ready or Not - Sunshine Act Data Collection Starts Today
August 1, 2013 | Blog | By Karen Lovitch
Today pharmaceutical and medical device manufacturers and group purchasing organizations (“GPOs”) start to collect data on their financial arrangements with physicians and teaching hospitals to comply with the Physician Payments Sunshine Act (‘‘Sunshine Act’’).
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HRSA CLARIFIES 340B ORPHAN DRUG EXCEPTION BUT 340B AUDIT ENFORCEMENT REMAINS MURKY
July 29, 2013 | Blog | By Theresa Carnegie
Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program.
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Chinese Investigation of GlaxoSmithKline Broadens as Details Emerge
July 24, 2013 | Blog
In the weeks since our first post on the Chinese investigation of GlaxoSmithKline (GSK) for alleged “widespread bribery of doctors” to induce the prescription of GSK’s drugs, more details have emerged about the bribery scheme.
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Former ArthroCare CEO and CFO Charged with Securities Fraud, Wire Fraud
July 23, 2013 | Blog
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.
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The Countdown Begins – Sunshine Act Data Collection
July 22, 2013 | Blog | By Theresa Carnegie
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.
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Proposed Medicare Cuts Would Significantly Impact Independent Laboratories
July 19, 2013 | Blog | By Karen Lovitch
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.
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First Year Analysis - The Pioneer ACO Program Wins Some, Loses Some
July 18, 2013 | Blog
This week, CMS announced the shared savings results and the clinical achievements from the first year of the Pioneer ACO Program.
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Keeping Up With the Kardashians Is NOT a Defense Under HIPAA
July 18, 2013 | Blog | By Karen Lovitch , Dianne Bourque
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.
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OIG Releases Online Self-Disclosure Form
July 16, 2013 | Blog | By Brian Dunphy
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.
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Hospitals Fight Back to Defend 340B Program Operations
July 11, 2013 | Blog | By Theresa Carnegie
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.
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Chinese Detain Pharmaceutical Company Managers in Economic Crime Probe
July 5, 2013 | Blog
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."
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OIG Issues Favorable Advisory Opinion Regarding Tiered Rebate Program
July 2, 2013 | Blog | By Theresa Carnegie
Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the "Requestor") tiered rebate program (the "Proposed Arrangement").
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CMS Conducts Star Ratings Best Practices Webinar
June 26, 2013 | Blog | By Roy Albert
CMS hosted a webinar yesterday focusing on best practices for Medicare Advantage and Prescription Drug Plan Sponsors looking to enhance their Star Ratings.
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Increased Availability of Health Care Data Means More Oversight and More Litigation
June 25, 2013 | Blog | By Theresa Carnegie
The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation.
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Court Rejects Urologists’ Appeal to Overturn Regulatory Changes to Stark Law
June 20, 2013 | Blog | By Theresa Carnegie
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.
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Texas Makes Changes to Medicaid Laws and Programs
June 19, 2013 | Blog | By Kimberly Gold
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.
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ML Strategies Posts Weekly Health Care Reform Update on June 17, 2013
June 17, 2013 | Blog | By Theresa Carnegie
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.
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First Circuit Rules First-Filed Complaint Need Not Satisfy Rule 9(b) to Bar Subsequent Qui Tam Actions
June 5, 2013 | Blog | By Karen Lovitch
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.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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