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Patients

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

by Hogan Lovells on

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s...more

An Arbitration Agreement That Attempts to Skew a Statutory Arbitration Scheme Is Void as Against Public Policy

Federal public policy favors arbitration and the broad interpretation and enforcement of arbitration agreements. So how can an arbitration agreement be held by a court to be void as against public policy? One answer from a...more

Health Law Insights: February Newsletter

by Roetzel & Andress on

ALERT: Technical Noncompliance with HIPAA Can Lead to Big Penalties- As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance...more

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

by Baker Ober Health Law on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

Direct Infringement Prong of 35 U.S.C. § 271(b) in a Hatch-Waxman Case May Be Satisfied When the Prescribing Physician Directs or...

by Locke Lord LLP on

On January 12, 2017, the Federal Circuit affirmed the district court’s holding that, under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc), the acts of patients may be...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Notes on Day 4 of the JPMorgan Healthcare Conference

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in...more

The Joint Commission Bans Text Messaging for Patient Care Orders

by Foley & Lardner LLP on

The Joint Commission, which accredits hospitals and other health care organizations, recently announced it will not permit hospitals and other health care organizations to use secure text messaging platforms to transmit...more

Patient Records Requests: What You Need to Know [Video]

by Reminger Co., LPA on

Our guest on Healthcare Matters is Richard J. Rymond, an attorney at Reminger Co., LPA, who specializes in in medical, dental and other forms of professional, commercial and general liability. He is the Dental Liability...more

Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare Conference

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week...more

EMA on optimising the development of advanced therapies

by Hogan Lovells on

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

CT Hospitals Have New Patient Disclosure Requirements Beginning in 2017

Beginning January 28, 2017, Connecticut hospitals must start notifying patients who schedule certain non-emergency diagnoses or procedures of their right to request related cost and quality information. This new requirement...more

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

by Holland & Knight LLP on

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

Update: Arkansas (Again!) Medical Board Approves Telemedicine Rules

by Foley & Lardner LLP on

The Arkansas State Medical Board on Thursday voted unanimously to pass Regulation 38 establishing key definitions for telemedicine practice in the State. The new regulation imposes specific Board of Medicine requirements for...more

The Learned Intermediary Rule in Consumer Protection Claims

by Reed Smith on

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes. See Andren...more

New OkPOLST form designed to improve end-of-life and crisis care

by McAfee & Taft on

Beginning Friday, August 26, 2016, Oklahomans have another tool available to them for use in planning end-of-life care and treatment. It’s called an OkPOLST, which stands for Oklahoma Physician Orders for Life-Sustaining...more

Missouri Governor Signs New Telemedicine Law

by Foley & Lardner LLP on

Missouri’s governor signed into law SB 579 (the “Act”), on June 8, 2016, establishing new telemedicine practice standards, including explicitly allowing a valid physician-patient relationship to be established via...more

Brief Reprieve Before Hospitals Must Provide Medicare Patients with “Observation” Notices

Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and...more

OIG Approves Hospice Payments to Nursing Facility for Dual Eligible Patients Under Medicaid Demonstration Project

by Baker Ober Health Law on

On July 20, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable Advisory Opinion (16-08) [PDF] regarding payments from a hospice to a nursing facility in which a dual...more

Two-Midnight Rule Update

by Carlton Fields on

Medicare and Medicaid Services (CMS) on August 19, 2013, the two-midnight rule provided that an inpatient admission generally would only be payable under Medicare Part A if: (1) the admitting practitioner had an expectation,...more

No More Surprises: Florida Ends Certain Medical Balance Billing

by Carlton Fields on

"Surprise medical billing" occurs when a patient receives care at a facility and receives treatment from a provider, such as an anesthesiologist or radiologist, who is not contracted with the patient’s health insurance plan....more

Tenth Circuit Rebukes CMS for Applying Wrong Regulations in Overpayment Action

by King & Spalding on

The United States Court of Appeals for the Tenth Circuit shot down CMS’s overpayment recoupment related to physical therapy and skilled nursing services, citing multiple errors in CMS’s appeal briefing and concluding that “an...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against Jerk.com - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website Jerk.com, a self-described reputation management...more

FDA Issues Guidance on Expanded Access

by Morgan Lewis on

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

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