Articles and Blogs

Health Law News

Breaking: HRSA Releases Preliminary Version of Proposed 340B Omnibus Guidance

[08/27/15]

Posted on August 27, 2015 in Health Law News

Published by: Hall Render

On August 27, 2015, the Health Resources and Services Administration (“HRSA”) released a notice of proposed 340B Drug Pricing Program Omnibus Guidance.  This notice (a copy of which can be found here) proposes to establish long-awaited and significant guidance for covered entities enrolled in, and drug manufacturers participating in, the 340B Program.  Once finalized... READ MORE

Tags:

OIG Issues Report Addressing Ownership Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors

[08/27/15]

Posted on August 27, 2015 in Health Law News

Published by: Hall Render

Background On August 13, 2015, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Memorandum Report (the “Report”) that examined the overlap between physician-owned hospitals (“POHs”) and physician-owned distributors (“PODs”) of spinal devices. PODs are medical device distributors whose owners are often physicians that use the devices sold by... READ MORE

Tags: ,

Value-Based Purchasing Is the New Normal: Opportunities for Savings in the Supply Chain

[08/07/15]

Posted on August 7, 2015 in Health Law News

Published by: Hall Render

Executive Summary Earlier this year, the Department of Health and Human Services (“HHS”) announced significant changes to Medicare by setting quantitative goals for its value-based payment programs. This payment reform is not only accelerating the shift away from fee-for-service toward a value-based system but also driving fundamental changes in how care is delivered. Health... READ MORE

NOTICE Act Requires Hospitals to Promptly Notify Medicare Patients of Observation Status

[08/04/15]

Posted on August 4, 2015 in Health Law News

Published by: Hall Render

On July 27, the Senate unanimously approved the Notice of Observation Treatment and Implication for Care Eligibility (“NOTICE”) Act, which was earlier approved unanimously by the House of Representatives in March. The bipartisan legislation will proceed to the President and is expected to be signed into law. The NOTICE Act makes changes to hospital... READ MORE

Tags:

What’s New with the 2-Midnight Rule?

[07/31/15]

Posted on July 31, 2015 in Health Law News

Published by: Hall Render

Executive Summary CMS recently published its CY 2016 Hospital OPPS and ASC Proposed Rule in which it proposes to create a new exception under the 2-Midnight Rule. The 2-Midnight Rule provides that hospital inpatient admissions are generally payable under Medicare Part A if the admitting physician (or other admitting practitioner) expected the patient to... READ MORE

Happy 50th Birthday Medicare and Medicaid: Midlife Crisis or the Golden Years?

[07/30/15]

Posted on July 30, 2015 in Health Law News

Published by: Hall Render

On July 30, 1965, President Lyndon B. Johnson signed into law what we now know as the Medicare and Medicaid programs.  They came into being after a long political gestation period that can be traced back to President Theodore Roosevelt’s proposals for a national health insurance system in 1912 and President Harry Truman’s 1948 bid... READ MORE

Tags:

Double Trouble: Lack of Safeguards with Internet Document Sharing Application and Mobile Devices Results in $218,400 HIPAA Settlement for Hospital

[07/20/15]

Posted on July 20, 2015 in Health Law News

Published by: Hall Render

Two separate alleged HIPAA violations resulted in an enforcement action by the Department of Health and Human Services (“HHS”) against a Massachusetts hospital (“Hospital”).  On July 10, 2015, the HHS Office for Civil Rights (“OCR”) announced a $218,400 settlement with the Hospital to resolve HIPAA investigations into two issues: READ MORE

Tags:

DOL Says “Most Workers Are Employees,” Not Independent Contractors

[07/17/15]

Posted on July 17, 2015 in Health Law News

Published by: Hall Render

On July 15, 2015, the U. S. Department of Labor (“DOL”) issued a Wage and Hour Division Administrator’s Interpretation that reasserts the broad definition of employee such that employers will rarely find that the individuals who work for them can be classified as independent contractors. This interpretation, although not having the effect of law,... READ MORE

Tags:

Home Health Prospective Payment System CY 2016 Proposed Rule: Here Comes Value-Based Purchasing

[07/13/15]

Posted on July 13, 2015 in Health Law News

Published by: Hall Render

Value-Based Purchasing Comes to Home Care On Monday, July 6, CMS issued the pre-publication copy of the proposed FY 2016 Home Health PPS Rule (the “Proposed Rule”).  The Proposed Rule will impose further cuts to home health reimbursement.  This is done in part through a continued application of the Affordable Care Act rebasing, which... READ MORE