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Implications of the U.S. District Court Opinion Vacating the 340B Program’s “Orphan Drug” Final Rule and Regulations

[05/29/14]

Posted on May 29, 2014 in Health Law News

Published by: Hall Render

Executive Summary On May 23, 2014, the United States District Court for the District of Columbia issued an opinion invalidating a final agency rule issued on July 23, 2013 (“Final Rule”) by the Health Resources and Services Administration (“HRSA”).  The Final Rule had served to clarify the scope of the 340B Program’s “Orphan Drug”... READ MORE

DSH Medicaid Eligible Days Documentation

[05/28/14]

Posted on May 28, 2014 in Health Law News

Published by: Hall Render

Executive Summary On Friday, May 23, 2014, the Provider Reimbursement Review Board (“PRRB”) released an alert directed at hospitals with pending appeals on the issue of allowable “Medicaid Eligible” days in the calculation of hospitals’ disproportionate share (“DSH”) payments.  Hospitals with Medicaid eligible day appeals have 60 days to provide additional information to the PRRB. ... READ MORE

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OIG Proposes Substantial Changes to Its Civil Monetary Penalty Rules

[05/21/14]

Posted on May 21, 2014 in Health Law News

Published by: Hall Render

Executive Summary On May 12, 2014, the Office of Inspector General (“OIG”) issued proposed rules to substantially revise its Civil Monetary Penalty Rules (“Proposed Rules”).  The Patient Protection and Affordable Care Act (“ACA”) and the Medicare Prescription Drug, Improvement and Modernization Act enhanced OIG’s statutory authority to exclude persons from participating in federal health... READ MORE

Congress Calls for Comments on Federal Legislative Changes Necessary to Encourage the Use of Telehealth Technology

[05/19/14]

Posted on May 19, 2014 in Health Law News

Published by: Hall Render

On May 1, 2014, the House Energy and Commerce Subcommittee on Health announced it is seeking input and feedback on federal legislation that would encourage the deployment and adoption of telehealth technology.  The announcement was made in conjunction with a hearing, “Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients,” led by... READ MORE

OIG Releases Its 2014 Compendium of Priority Recommendations

[05/19/14]

Posted on May 19, 2014 in Health Law News

Published by: Hall Render

What Is the “Compendium of Priority Recommendations”? In March 2014, the Department of Health and Human Services Office of the Inspector General (“OIG”) published the 2014 “Compendium of Priority Recommendations” (“Compendium”), a compilation of 25 of its most significant open recommendations that, in OIG’s view, would best protect the integrity of HHS programs, if... READ MORE

CMS Issues Final Rule Establishing Medicare FQHC Prospective Payment System

[05/16/14]

Posted on May 16, 2014 in Health Law News

Published by: Hall Render

Executive Summary On May 2, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule (“Final Rule”) establishing a prospective payment system (“PPS”) for Federally Qualified Health Centers (“FQHCs”).  As a result of this rule, PPS reimbursement will be mandated for both FQHC “look-alikes” and Section 330 grant recipients effective for... READ MORE

CMS Publishes Final Rule on Enforcement Actions for CLIA Proficiency Testing Referral

[05/13/14]

Posted on May 13, 2014 in Health Law News

Published by: Hall Render

On May 2, 2014, CMS published a final rule (“Final Rule”) amending the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) by fully implementing the Taking Essential Steps for Testing Act of 2012 (“TEST Act”) and establishing three categories of sanctions for proficiency testing referral (“PT referral”). READ MORE

CMS Seeks Comments on Dispute Resolution and Corrections Process for Sunshine Act Payments

[05/09/14]

Posted on May 9, 2014 in Health Law News

Published by: Hall Render

According to a Federal Register notice published on May 5, physicians and teaching hospitals will soon be able to register with the Centers for Medicare and Medicaid Services (“CMS”) to receive notices from and access to CMS’s Open Payments database.  The Open Payments database will contain information about payments and other transfers of value that... READ MORE

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HHS Announces Largest HIPAA Settlement to Date

[05/09/14]

Posted on May 9, 2014 in Health Law News

Published by: Hall Render

On May 8, 2014, the Department of Health and Human Services (“HHS”) announced that it had reached settlements with two health care organizations arising from alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy and Security Rules.  The settlements result from the organizations’ failure to secure thousands of patients’ electronic protected... READ MORE

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