Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

Vendor Causes Breach of Over 5,000 Patient Records

The continued risk that vendors pose to companies, including health care entities cannot be overemphasized. This week, Sentara Healthcare (Sentara) announced that one of its third-party vendors was the victim of a...more

HHS OIG Issues Final Regulation Addressing Exclusion Authority

On January 12, 2017, the HHS OIG issued its final rule amending regulations relating to its authority under the Affordable Care Act (ACA) to exclude individuals and entities from participation in federal healthcare programs....more

The Trump Administration’s View on Marijuana: Reading the (Tea) Leaves

The incoming Trump Administration may usher in a more hostile climate to state efforts to legalize the sale and distribution of marijuana and products that contain the drug. The Obama Administration opposed the federal...more

Potential Implications to the ACA Under the Incoming Republican Administration

Over the course of the last six years in Washington, D.C., one of the primary goals of the Republican Party has been to repeal the Affordable Care Act (ACA). Since the Republican Party gained control of the House of...more

Longitudinal Study Finds that Post-Concussion Syndrome (PCS) May Be Permanent

University of Toronto researchers have just published an important longitudinal study following patients with Post-Concussion Syndrome (PCS) based on a diagnosis of concussion in conformity with the international sport...more

Health Care Group News: OCR Releases New Clarifying Guidance In Response To Orlando Pulse Nightclub Attack

In an emergency, when there is a flurry of activity in a hospital, covered entities often struggle with who they are permitted to release patient information to under HIPAA. On January 11, 2017, the Department of Health and...more

REDIAL: 2016 TCPA Year In Review – Analysis of Critical Issues and Trends

The Sutherland TCPA team has published its third annual REDIAL: 2016 TCPA YEAR IN REVIEW – ANALYSIS OF CRITICAL ISSUES AND TRENDS. This publication reflects our in-depth analysis of significant Telephone Consumer...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Avoiding COBRA’s Bite: Measures to Counter COBRA Class Actions

With the filing of a class action complaint in late 2016 in the U.S. District Court for the Southern District of Florida, Wal-Mart Stores, Inc. became the latest large company accused of failing to provide adequate notices as...more

Perspectives for the Professions - January 2017: Case Summary: Test for Interim Conditions

Scott v. College of Massage Therapists of BC, 2016 BCCA 180, allowing an appeal of the lower Court’s decision to quash an interim condition on practice. A massage therapist was the subject of a complaint that he had...more

CDC Issues Final Quarantine Rule to Strengthen Control of Communicable Diseases

The Centers for Disease Control and Prevention (CDC) has issued a final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States...more

Iowa Drug Pricing Disclosure Law Bites the Dust

In 2014 Iowa enacted a statute requiring pharmacy benefit managers (PBMs) to disclose pricing methodologies to their network pharmacies and to the State Insurance Commissioner. Is the statute “a patchwork of costly mandates...more

Capitol Hill Healthcare Update

The House on Friday gave final congressional approval to a budget blueprint that authorizes separate filibuster-proof legislation Republicans will use next month to repeal much of the Affordable Care Act...more

Manatt on Health Reform: Weekly Highlights - January 2017 #2

CBO estimates 27 million would lose coverage under partial ACA repeal in the first year after elimination of Marketplace subsidies and Medicaid expansion; a federal judge orders delay in submission of North Carolina’s...more

Government Affairs Insights - Obamacare: Charting the Shoals Ahead

This nation’s latest effort to lower the rate of uninsured health care recipients and improve health outcomes was launched with President Obama’s approval in 2010 of the Patient Protection and Affordable Care Act (ACA or...more

OIG Rings in the New Year With New Anti-Kickback Statute Safe Harbors

Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more

Medicaid: Significant Changes Coming in 2017 and Beyond

With Congress back in session, attention in the health care policy universe is directed squarely at Washington, where Republicans in Congress and the Trump Administration are debating how to repeal and replace the Affordable...more

Washington Supreme Court Expands Physicians’ Duty to Third Parties

Most states have laws either requiring or permitting mental health professionals to disclose information about patients who may become violent. These voluntary or mandatory reporting laws require a balancing of the...more

SAMHSA Releases Final and Supplemental Proposed Rules on Substance Abuse Records Privacy Protections

A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. SAMHSA explains in the preamble that...more

Enough is Enough: Court Dismisses TCPA Class Action Against A Health Plan That Placed Reminder Calls To Its Members That They...

Plaintiffs across the country have continued to file class actions against companies of all stripe for violation of the Telephone Consumer Protection Act (“TCPA”), often for communications far afield from the classic...more

Does Your Nursing Home Discharge Notice Comply with the New Federal Requirements?

Long-term care providers should check their form notice of discharge to ensure that it complies with the new requirements sent forth in 42 C.F.R. § 483.15. The updates to this regulation were effective November 28, 2016....more

Summary of FDA Guidance on the Nonproprietary Naming of Biological Products

On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency’s ongoing efforts to implement the Biologics Price...more

Obama Administration Finalizes Changes to Home Health Conditions of Participation

CMS has finalized extensive changes to the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced...more

Burr Alert: New Requirements of Participation for Skilled Nursing Facilities

On October 4, 2016, The Centers for Medicare and Medicaid Services (“CMS”) released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

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