News & Analysis as of

FDA data underscores why patients need to ask tough questions about care

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed...more

KBML Issues Guidance to Help Physicians Get the Most out of MOST

The Kentucky Board of Medical Licensure (“KBML”) issued a recent opinion regarding the Medical Orders for Scope of Treatment (“MOST”) form. The stated purpose of the opinion is to “encourage and promote clarification of a...more

OMNICARE and its Implications

In the spring of this year, the Supreme Court issued its long-awaited decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S.Ct. 1318 (2015), resolving a circuit split regarding the...more

OIG Issues Favorable Opinion Giving Green Light To Health System’s Shuttle Service

The Office of Inspector General (OIG) recently issued another advisory opinion on free patient transportation (OIG Adv. Op. No. 15-13, dated October 21, 2015). In the opinion, the OIG addresses whether providing patients a...more

Alert: Proposed 340B Drug Pricing Program Omnibus Guidance - Defines "Eligible Patient"

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published the proposed 340B Drug Pricing Program Omnibus Guidance (“Omnibus Guidance”) which is intended to clarify for covered entities, such as...more

Government Finally Investigating Power Morcellators

Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is...more

FCC Clarifies the Requirements for Sending Wireless Calls and Text Messages to Patients

The Federal Communications Commission ("FCC") recently clarified questions surrounding wireless patient calls and text messages, and the requirements of the Telephone Consumer Protection Act (“TCPA”). The TCPA protects...more

Also In The News - Health Headlines - October 2015 #3

CMS Announces Part D Enhanced Medication Therapy Management Model Demonstration – On September 28, 2015, CMS announced a Part D Enhanced Medication Therapy Management Model (Enhanced MTM Model) that is designed to assess...more

President Obama Signs Bills to Amend ACA Small Employer Definition, Expand Access to Clinical Trials

On October 7, 2015, President Obama signed into law H.R. 1624, which amends the Affordable Care Act’s (ACA) definition of “small employer” by maintaining the definition of a small group market as 1-50 employees and thus...more

California Governor Sets Robust Regulatory Scheme for Medical Marijuana in Motion with Signing of Legislation

California Gov. Jerry Brown signed a group of medical marijuana laws on Oct. 9 that will have a widespread effect on how the entire industry is regulated in the state. The governor approved AB266, along with AB243 and SB643....more

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Also In the News - Data, Privacy, & Security Practice Report - October 2015

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (“ONC”) of HHS laid out the federal government’s final version...more

Divided Infringement Between Doctor and Patient

Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more

FDA Establishes Patient Engagement Advisory Committee

The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D.,...more

Illinois Enacts Patient Notification Requirement for Observation Stays

Illinois joins a growing number of states to pass laws requiring that hospitals provide notice to patients who are placed under observation status. 210 ILCS 86/6.09b As with the recent federal NOTICE Act, the laws respond to...more

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

Obama Signs Law Requiring Hospitals to Warn of Costly Medicare Loophole

President Obama has signed a new law intended to prevent Medicare beneficiaries from spending days in a hospital only to find that they hadn’t been admitted to the hospital at all – they were only under “observation.” This is...more

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients

New guidance from the Health Resources Services Administration (HRSA) clarifying certain definitions integral to the 340B Drug Pricing Program (“340B Program”) will significantly limit the number of patients eligible to...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

76 Results
View per page
Page: of 4

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.