New Licensing and Regulatory Requirements for Pharmacy Benefit Managers in Ohio

House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to…more
| Health, Science, Computers, & Technology

Operating a Well in California May Automatically Put You At Risk for a Prop 65 Lawsuit

California's Proposition 65 is notorious for its duty-to-warn requirement, which states that a business must give a clear and reasonable warning prior to exposing people to certain levels of any listed chemical. The warning…more
| Energy & Utilities, Environmental Law, Zoning, Planning & Land Use

DOJ Reaffirms Commitment to Prosecuting Individuals, Toughens Expectation for Corporate Response

The U.S. Department of Justice (DOJ) recently issued a memorandum ("The Yates memo") on September 9, 2015 by Deputy Attorney General Sally Yates, reaffirming the Government's commitment to prosecuting individuals. Say good-bye…more
| Commercial Law & Contracts

Payment Innovation: 30 Day Window to Provide CMS Comments on Physician Payment Changes Under MACRA Begins

On September 28, 2015, the Centers for Medicare & Medicaid Services (CMS) published a Request for Information (RFI) seeking stakeholder comments related to innovative physician payment models required by the Medicare Access and…more
| Health

CMS Proposes Overhaul of Clinical Lab Payment Methodology: What You Need To Know

On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed…more
| Health, Science, Computers, & Technology

Polsinelli Podcast- Does Your Business Succession Plan Align With Your Estate Plan? [Video]

You’re a successful business owner who spends most of your time operating your business. While you probably have a business succession plan, does it coordinate with your estate plan? In this week’s Polsinelli Podcast,…more
| Wills, Trusts, & Estate Planning

NLRB: Peer Review Obligations Trumped by NLRA

On August 27, 2015, the National Labor Relations Board (“NLRB”) held that a Kansas hospital must afford an employee Weingarten rights before a nursing Peer Review Committee, allow the union access to peer review documents and…more
| Health, Labor & Employment Law

Beware the Boilerplate: Request for Attorneys' Fees in Arbitration Can Haunt You Later

The general rule in litigation is that each side pays its own legal fees, regardless of who wins. There is no fee shifting. Exceptions to that general rule primarily exist in the form of contractual arrangements or statutes…more
| Alternative Dispute Resolution (ADR), Civil Procedure

Practices, Optics and Implications: A Cautionary Tale from the North Broward Hospital District Settlement

The $69.5 million settlement by North Broward Hospital District in Fort Lauderdale, Florida to resolve False Claims Act allegations paints a cautionary tale of the importance of hospital practices and optics in connection with…more
| Government Contracting, Health

Ferguson Commission Urges Greater Access to Banking in Disadvantaged Communities

This week, the Ferguson Commission released an analysis of the socio-economic environment following the shooting of Michael Brown that included recommendations for financially strengthening lower-income areas. The Commission,…more
| Commercial Law & Contracts, Finance & Banking

Summary of Key 340B Omnibus Guidance Proposals

As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated HRSA…more
| Health

Polsinelli Podcast - Benefits of Forming a Small Business Investment Company [Video]

Have you considered an investment in or creating a Small Business Investment Company (SBIC)? Doing so may provide financial institutions with a number of benefits under the Community Reinvestment Act. In this week's Polsinelli…more
| Finance & Banking

New Restrictions: CMS Limits Scope of Review on Redeterminations and Reconsiderations for Certain Audit Appeals

On August 13, 2015, the Centers for Medicare & Medicaid Services (CMS) issued instructions to Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) regarding the scope of review for…more
| Health

First FDA FSMA Rules Have Landed; More Likely to Follow by End of Year

Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive…more
| Administrative Law, Commercial Law & Contracts, Communications & Media Law

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch…more
| Administrative Law, Health, Science, Computers, & Technology
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