Blog

FDA Releases Final Post-Market Guidance on Medical Device Cybersecurity

[01/11/17]

Posted on January 11, 2017 in Health Law News

Published by: Hall Render

On December 27, 2016, the Food and Drug Administration (“FDA”) issued final guidance (the “Post-Market Guidance”) outlining steps that medical device manufacturers and health care systems should take to monitor, identify, understand and address cybersecurity risks once medical devices and mobile medical devices have entered the marketplace. The Post-Market Guidance follows October 2014 FDA guidance…Read More

After More Than Two Years, CMS Releases Final Home Health CoPs

[01/10/17]

Posted on January 10, 2017 in Health Law News, Long-Term Care, Home Health & Hospice

Published by: Hall Render

This time things are really going to change. On January 9, 2017, the Centers for Medicare & Medicaid Services (“CMS”) released a pre-publication copy of the Final Revised Home Health Conditions of Participation (“Final CoPs”). With the release of the Final CoPs, CMS is finalizing, with only a few changes, the significant changes they proposed to make…Read More

Permitted Financial Arrangements Between Participant Hospitals and Physician Group Practices Under the New Cardiac-Related Episode Payment Models

[01/10/17]

Posted on January 10, 2017 in Health Law News

Published by: Hall Render

Pursuant to its recently issued final rule (“Rule”), CMS is implementing two cardiac-related episode payment models (“EPMs”). One of the EPMs pertains to episodes of care surrounding an acute myocardial infarction (“AMI EPM”); the other EPM pertains to episodes of care surrounding a coronary artery bypass graft (“CABG EPM”). Generally, participation in the AMI and…Read More

OIG Report on Inpatient Rehabilitation Hospitals Signals the Potential for Increased Scrutiny

[01/09/17]

Posted on January 9, 2017 in Health Law News

Published by: Hall Render

On December 23, 2016, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a report (the “Report”) detailing a case review of inpatient rehabilitation (“rehab”) hospitals.1 The Report indicates that for 39 out of 426 rehab hospital stays reviewed, the patient was unable to participate in and benefit significantly from intensive…Read More

Hall Render’s Health Law Year in Review: Here’s What Happened in 2016 as We Launch into 2017

[01/09/17]

Posted on January 9, 2017 in Health Law News

Published by: Hall Render

As the health care industry and the related body of health law shift like tectonic plates, Hall Render attorneys are committed to providing practical counsel and insight to health care providers. Below is a compilation of key developments from 2016 that will continue to impact the health care industry in 2017. As the new year…Read More

Hall Render’s This Week in Washington – January 6, 2017

[01/06/17]

Posted on January 6, 2017 in Federal Advocacy

Published by: Hall Render

Senate Takes First Step Towards ACA Repeal On January 4, the U.S. Senate took the first step towards repeal of the Affordable Care Act (“ACA”). The Senate voted 51-48 to advance a fiscal 2017 budget resolution (S. Con Res 3) that allows Congress to use the parliamentary procedure known as budget reconciliation to repeal parts…Read More

Compliance-Driven Contract Management Solutions

[01/05/17]

Posted on January 5, 2017 in Health Law News

Published by: Hall Render

Contract management plays an important role in the day-to-day operations of any hospital or health system. With increased governmental scrutiny on hospital and physician arrangements, the need to ensure and track compliance across a health system’s portfolio of contracts is vital. An effective contract management program helps a health system to implement appropriate controls to…Read More

Pharmacy Fraud and Abuse: Operationalizing the New OIG Final Rule in an Integrated Care Environment

[01/04/17]

Posted on January 4, 2017 in Health Law News

Published by: Hall Render

The role of pharmacists and pharmacies as integral cogs in the patient care continuum continues to grow, thanks in no small part to incentives encouraging integrated and coordinated care designed to enable improved outcomes at lower cost. From Medicare bundled payment initiatives that include drug costs to third party payor reimbursement reductions driven by pharmacy…Read More

CMS Issues Guidance on Extraordinary Circumstance Relocation Exception Guidance for a Hospital Off-Campus Provider-Based Department

[01/03/17]

Posted on January 3, 2017 in Health Law News

Published by: Hall Render

On December 7, 2016, the Senate passed the 21st Century Cures Act (“Cures Act”), which revised Section 603 of the Bipartisan Budget Act of 2015 (“Section 603”) to provide an exception for off-campus provider-based departments (“PBDs”) that were mid-build or under development prior to November 2, 2015. The Cures Act was signed into law by President…Read More

On-Campus Medical Office Buildings: Is a Premium Warranted? If So, When and Why?

[12/28/16]

Posted on December 28, 2016 in Health Law News

Published by: Hall Render

Health care real estate assets are often referred to as being located “on-campus” or “off-campus.” While real estate market participants may differ in their criteria for referring to a property as on- or off-campus, the Centers for Medicare & Medicaid Services (“CMS”) defines a hospital campus in the provider-based regulations at 42 C.F.R. § 413.65(a)(2)…Read More