Proposed Settlement Would Expand Medicare Coverage
October 30, 2012
A proposed settlement agreement filed this week would remove the need to show improvement to qualify patients for certain therapy services, which would expand coverage of...
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U.S. Senate Draft Legislation Aims to Improve Security of the Drug Distribution System
October 29, 2012
On October 24, 2012, Tom Harkin, Chair of the U.S. Senate Health, Education, Labor and Pensions Committee, circulated for comment by stakeholders draft legislation that...
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CMS Announces Delay of Bundled Payment Initiative Model 1 Enrollment
October 25, 2012
The Centers for Medicare and Medicaid Services ("CMS") Center for Medicare and Medicaid Innovation ("CMMI") announced the delayed implementation of...
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Massachusetts Holds Hearing on Rules that Remove Reporting Requirements
October 25, 2012
A public hearing was held today on emergency regulations in Massachusetts that apparently abolish all transparency reporting requirements except for new reporting...
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OIG Study Finds Prescription Reimbursements Could Drop Under PPACA Policy
October 24, 2012
On October 16, 2012, OIG released a report finding that although Medicaid is overpaying for prescription drugs under current policy, a new policy in the Patient...
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OIG Issues Advisory Opinion 12-14
October 23, 2012
On October 9, 2012, the Office of Inspector General ("OIG") issued Advisory Opinion 12-14, in which OIG stated that it would not impose sanctions against a...
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IRS Announces Date Change for Proposed Hearing on Additional Requirements for Charitable Hospital
October 22, 2012
On October 16, 2012, the Internal Revenue Service ("IRS") announced in the Federal Register that the public hearing on proposed regulations establishing...
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Sixth Circuit Overturns $82.6 Million FCA Decision Against Fresenius
October 18, 2012
On Friday, October 5, 2012, the Sixth Circuit Court of Appeals overturned an $82.6 million judgment against Fresenius Medical Care Holdings ("Fresenius") in a...
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Annual Appellate Review - Cases that Matter to Business
October 18, 2012
Experienced members of Fulbright's Appellate Practice Group provided an overview of key decisions that will influence how your business operates and...
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FDA Considers Accelerated Approval Process for Certain Drugs
October 17, 2012
The U.S. Food and Drug Administration ("FDA") is considering plans to bring speedier U.S. approval to drugs deemed to offer greater societal benefits than risks...
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OIG Report Offers Corporate Integrity Agreement Best Practices
October 16, 2012
The U.S. Department of Health and Human Services Office of Inspector General ("OIG") held a roundtable discussion on August 7, 2012 in which OIG sought feedback...
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Study Finds CMS Penalty Did Not Change Hospital-Acquired Infection Rates
October 15, 2012
A 2008 policy from the Centers for Medicare & Medicaid Services ("CMS") that prohibits payments to hospitals for certain preventable hospital-acquired...
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GAO Report Evaluates 2010 Ambulance Costs, Reimbursement
October 11, 2012
On October 1, 2012, the Government Accountability Office ("GAO") published a report in which it identified ambulance provider costs per transport and...
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FDA Delays Food Maker Registration Renewals
October 10, 2012
Under the new Food Safety Modernization Act ("FSMA"), all food facilities that are required to register with FDA under section 415 of the Food, Drug, and...
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Lack of Funding Delays Implementation of Rules Under the FSMA
October 10, 2012
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On October 1, 2012, FDA Commissioner Margaret Hamburg announced an additional delay involving the FSMA. She stated that the implementation of rules required by the FSMA...
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