Also In The News - Health Headlines - April 2015 #4

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CMS Announces Round 1 2017 DMEPOS Competitive Bidding System – On April 21, 2015, CMS announced plans for a new bidding process for the supplier contracts awarded in the Round 1 Recompete of the DMEPOS Competitive Bidding Program for contracts beginning January 1, 2017.  The current contracts are set to expire on December 31, 2016. 

CMS Releases MLN Matters Article Regarding Documentation Requirements – CMS recently released an MLN Matters Article clarifying documentation requirements for providers or suppliers who furnish ordered DMEPOS, imaging services, clinical lab services, or ordered/certified home health services.  The article clarifies the term “access to documentation” in Chapter 15 of the CMS Program Integrity Manual.

OIG Report Finds MFCUs Recovered Nearly $300 Million in FY 2014 According to the OIG’s Medicaid Fraud Control Units (MFCUs) Fiscal Year 2014 Annual Report, MFCUs recovered nearly $300 million from criminal cases in FY 2014.  According to the report, this figure represents a more typical year after the blockbuster recovery in FY 2013 of $969 million due to one single criminal case. 

Re-Aligning Hospital Merger Guidance – In last week’s Health Headlines edition, we referenced a study by the National Academy of Social Insurance.  This week, we highlight a study offering a different perspective on hospital mergers and the factors that should be considered when analyzing their overall effects, “Re-Aligning Prospective Hospital Merger Guidance:  Moving Beyond Concentration to More Meaningful Approaches,” which is available from the Social Science Resource Network by clicking here.

Change is in the Air: How the Recently Passed SGR Legislation and Medicare’s FY 2016 IPPS/LTCH Proposed Rule May Affect YOU On Friday, May 1, 2015, King & Spalding will host an Atlanta-based Roundtable analyzing the winners and losers under the recently passed legislation repealing the Sustainable Growth Rate (SGR) as well as the essential items contained in CMS’s 2016 Inpatient Prospective Payment System (IPPS) proposed rulemaking. The Roundtable will focus on the SGR fix, the 2016 IPPS numbers, the latest on DSH/UCC payments, pay-for-performance, the “two midnight rule,” LTCHs and the Medicare electronic health records incentive program.  To attend the Roundtable in-person or via webinar, click here.

Cancer in the Crosshairs: The Unique Regulatory and Transactional Challenges of Combination-Therapy Clinical Trials for Immuno-Oncology – On Thursday, April 30, 2015, King & Spalding will present an interactive web seminar discussing the unique and challenging aspects of conducting clinical trials of combination Immuno-Oncology therapies—i.e., two drugs from two companies administered in conjunction to test whether the combination is superior to a single-agent treatment regimen.  A panel of experienced Life Sciences transactional and FDA/Regulatory attorneys will explore some of these challenges, including best practices for negotiating the clinical trial collaboration; design and control of the combination trial; supply of the drug products; control of the resulting clinical data; interactions with the FDA and other regulatory agencies; how to protect the added regulatory value created by combination clinical trials; and key topics that each company’s business, legal, commercial and clinical teams should consider.  For more information and to register, please click here

Attend a King & Spalding LLP Health Law & Policy Forum Session by Video – Did you miss the King & Spalding Health Law & Policy Forum?  The firm will be making individual sessions available by video over the coming weeks for a small fee.  King & Spalding LLP is now pleased to offer the session titled, “Highlights from the IRS Final Section 501(r) Regulations Applicable to Tax-Exempt Hospitals.” Please click here to register to view this session.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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