Patients Healthcare

News & Analysis as of

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

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

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

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

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

Waivers of Co-Pays and Deductibles: Insurance Benefit Exclusions Grow

Recent changes to policy and plan language and increased litigation by third-party payers suggests that out-of-network providers who waive co-pays and deductibles may be in for some rough sailing. Providers must be aware of...more

340B Program Change on the Horizon? OMB Completes Review of the 340B Omnibus Guidance

Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more

Telehealth Roundup: Federal Bill Seeks to Expand Medicare Use of Telehealth; Delaware and Connecticut Update Telemedicine Laws

On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg...more


The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

Steps to Take Before Terminating a Physician-Patient Relationship

At times physicians are faced with the burden of having to remove a patient from their practice. Circumstances leading up to this unfortunate decision may include a difficult or disruptive patient who is abusive to the staff...more

What patients misunderstand about their right of informed consent [Video]

Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more

Physician Owned Distributorship Concerns Continue to Make News

On June 17, 2014, Southern California Public Radio affiliate KPCC broadcasted a report about physician-owned distributors of implantable medical devices (“PODs”) and the legal and ethical concerns that are raised when POD...more

AB 1000 and Corporate Practice in California: More than Meets the Eye—or Less?

On the way to authorizing direct access to physical therapy, the California legislature may have broadly loosened the restrictions on numerous business arrangements imposed by California’s corporate practice ban. AB 1000,...more

The American Board of Obstetrics and Gynecology Reverses Its Unlawful Ban on Treating Male Patients

In September of 2013, the American Board of Obstetrics and Gynecology adopted a policy of excluding obstetrician/gynecologists from eligibility for Board certification and recertification if they treated any male patients....more

SAMHSA to Hold Part 2 “Listening Session”

The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has scheduled a “public listening session” on Wednesday, June 11, 2014, to seek input on potential changes to the federal Confidentiality of Alcohol and...more

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