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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Michigan Strikes Back . . . In Pennsylvania

by Reed Smith on

A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act. It contained a provision providing the manufacturers of FDA-approved drugs with immunity from...more

Digital Health Care Investors Summit Highlights Digital Health Expansion

by Foley & Lardner LLP on

In early December, leading experts in digital health and telemedicine came together at the Digital Health Care Investors Summit hosted by Foley & Lardner LLP and Deloitte. The Summit explored innovations in digital health...more

Pill Mills, Poppy Flowers, Dead Poets and the Human Resources Department

Having been through a seven-week federal criminal “pill mill” trial, I think a lot about enforcement of the Controlled Substances Act and its effect on physicians. Aggressive enforcement effects others in healthcare as well,...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

CMS Terminates and Scales Back Mandatory Bundled Payment Models

by Polsinelli on

The Centers for Medicare & Medicaid Services (CMS) recently published a final rule that cancels the Episode Payment Models (EPMs) and the Cardiac Rehabilitation (CR) incentive payment model, each of which were slated to begin...more

Diabetes Monitoring Technology Moving Toward Consumer Convenience

by Knobbe Martens on

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Alabama CON Report

I. Certificate of Need Program - A. Project Modification AL2016-022, Geneva County Health Care Authority, Inc., Geneva, AL: Proposed to acquire, relocate and operate five (5) geriatric psychiatric inpatient beds as an...more

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

Pennsylvania Supreme Court Breathes New Life into Survival Actions

by Barley Snyder on

The Pennsylvania Supreme Court gave new life to otherwise time-barred survival action claims in medical malpractice cases in a significant decision last month – even if one justice was blunt in his disagreement with the...more

K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

by K&L Gates LLP on

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more

OCR Warns Health Care Industry of Risks with Previous Employees

In its November newsletter, the Office for Civil Rights (OCR) made a great point that we are seeing in the industry—the risks associated with previous employees. According to its newsletter, entitled “Insider Threats and...more

Three Reasons Why Giving Your House to Your Children Isn't the Best Way to Protect It From Medicaid

You may be afraid of losing your home if you have to enter a nursing home and apply for Medicaid. While this fear is well-founded, transferring the home to your children is usually not the best way to protect it....more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Todd Atwater Announces Bid for South Carolina Attorney General- Republican state Representative Todd Atwater has declared his candidacy for South Carolina AG in 2018. ...more

CMS Extends Medicare Prior Authorization Program for Repetitive Scheduled Non-Emergent Ambulance Transport

by Reed Smith on

CMS is extending for another year the Medicare prior authorization program for repetitive, scheduled non-emergent ambulance transport services rendered by ambulance providers in selected states. As previously reported, CMS...more

CMS Schedules Feb. 13 Town Hall Meeting on IPPS New Tech Applications

by Reed Smith on

On February 13, 2019, CMS is holding a public Town Hall meeting to discuss requests for add-on payments for new medical technologies under the Medicare hospital inpatient prospective payment system (IPPS). ...more

OIG Highlights Recent Audit, Investigation, and Enforcement Accomplishments

by Reed Smith on

The Office of Inspector General (OIG) of the Department of Health and Human Services has released its semiannual report for the period of April 1, 2017, through September 30, 2017. The report also includes aggregated data for...more

Guest Post: Christmas Came Early on December 8 – Favorable Developments in Fosamax & Accutane Litigation

by Reed Smith on

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog. Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions...more

MedPAC Issues Report on Supervision Requirements in Critical Access Hospitals and Small Rural Hospitals

by King & Spalding on

In December 2017, the Medicare Payment Advisory Commission (MedPAC) issued a report to Congress analyzing the impact of physician supervision requirements in critical access hospitals (CAHs) and small rural hospitals. ...more

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

by McDermott Will & Emery on

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

Memo to Massachusetts Employers for 2018 and 2019: How Not to Comply with the EMAC New Rules

In a November 20, 2017 post, we reported on Massachusetts’ passage of H. 3822, “An Act Further Regulating Employer Contributions to Health Care,” (the “Act”), the purpose of which is to shore up the finances of the...more

Manatt on Health: North Carolina: Amended 1115 Waiver Application

On November 20, 2017, North Carolina submitted an amended 1115 waiver application to the Centers for Medicare & Medicaid Services (CMS) seeking authority to invest $1.2 billion over five years in a range of targeted...more

What's Next Now that Mandatory EPM and Cardiac Rehabilitation Payment Models Have Been Terminated?

by Baker Ober Health Law on

CMS released its Final Rule canceling the Episode Payment Model (EPM) and Cardiac Rehabilitation Incentive Payment Model (CR Incentive Payment Model). This was an expected result following August's proposed rule to cancel...more

Telehealth Opportunities Worth Watching in 2018

Continued physician shortages, reduced reimbursement from government and private insurance plans and the ever-increasing health care needs of an aging population are forcing payors and providers alike to increase the...more

EDNY Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

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