Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

Managing the Transition to Transformation: Alternative Payment Systems: Evolving Compliance Challenges

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

New POS Code for Telehealth Distant Site Providers

A new Place of Services or POS code for Telehealth services (POS 02) will go into effect on January 1, 2017. The descriptor for the code, which is for use by the physician or other clinician furnishing telehealth services...more

What Employment Law Changes Should We Expect From the Trump Administration? Ask the Magic 8 Ball

If you had asked me one month ago to predict the winner of the presidential election, I would have been wrong. Therefore, rather than make my own [ill-fated] predictions of the changes that await employers when PEOTUS takes...more

Additional Clarification regarding HHS OCR Phishing Email Alert

More information from HHS OCR about the phishing threat... ..On November 28, 2016, the HHS Office for Civil Rights issued a listserv announcement warning covered entities and their business associates about a phishing...more

Trial Challenging Proposed Anthem, Cigna Merger Is Underway

On November 21, 2016, the U.S. District Court for the District of Columbia heard opening arguments in the Department of Justice’s lawsuit challenging the proposed merger between Anthem, Inc. and Cigna Corporation. This is...more

Manatt on Medicaid: Monthly Expansion Recap - December 2016

Post-Election Reactions and Activity in the States - Arizona: Former Governor Voices Support for Medicaid Expansion - Former Governor Jan Brewer (R), who served from 2009 to 2015, is encouraging President-elect...more

OCR Provides Additional Clarification on Phishing Scam

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2...more

Refined 21st Century Cures Act Passes in House and Heads to Senate Next Week

Yesterday, we reported that the House of Representatives was set to vote on a revised draft of the 21stCentury Cures Act...more

Capitol Hill Healthcare Update

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

False Claims Act: Recent First Circuit Opinion on Remand in U.S. ex rel. Escobar v. United Health Services

Earlier this year, the U.S. Supreme Court’s important opinion in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), dealt with the issue of whether a so-called “implied certification” that a...more

Micro-Units under the Microscope: The Second and Fifth Circuit Courts Consider Specialty Healthcare and Its Misapplication

Last week, the U.S. Court of Appeals for the Second Circuit joined the Third, Fourth, Fifth, Sixth, Seventh, and Eighth Circuits in upholding the Board’s Specialty Healthcare standard for determining appropriate bargaining...more

OCR Alerts Listservs About Fake Phishing Email to Covered Entities and Business Associates

On November 28, 2016, the Office for Civil Rights (OCR) issued an Alert to its listservs that a phishing email is being circulated on “mock HHS Departmental letterhead under the signature of OCR”s Director, Jocelyn Samuels”...more

HHS Releases Inflation Adjusted Federal Civil Penalties

The Department of Health and Human Services has issued new interim final rules to adjust a variety of Federal Civil Penalties for inflation. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015...more

Employers Need To Be Aware Of Potential Pitfalls Of Providing Opt-Out Incentives To Company Health Insurance

In recent proposed regulations, the Internal Revenue Service (IRS) addressed how the Affordable Care Act (ACA) impacts the use of employer opt-out incentives, which are payments to employees who decline an employer’s group...more

The ERISA Litigation Newsletter - November 2016

This month we review a recent Second Circuit decision addressing ERISA plan status as a class member in a securities shareholder class action. As discussed in the article, the decision exposes a potential conflict among the...more

Health Alert (Australia) November 28 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 23 November 2016 - Tolley v Secretary, NSW Ministry of Health in respect of Northern NSW Local...more

Pharmacy Benefit Managers Face New Licensing Requirements

Two states recently enacted new pharmacy benefit manager licensing requirements that affect pharmacy benefit managers in Kentucky and New Mexico. It is important for Pharmacy Benefit Managers to ensure they are in compliance...more

Florida Amendment 2 Rolls at the Polls: Getting into the Weeds of Medical Marijuana

By an overwhelming 71% of voters saying “yes” to Amendment 2 on Election Day, Floridians successfully made Florida the first Southern state to legalize medical marijuana....more

OCR Examines Hybrid Entity Designation in Latest HIPAA Settlement

On November 22, 2016, the University of Massachusetts Amherst (UMass) agreed to pay $650,000 and enter into a corrective action plan to settle allegations that it violated the HIPAA Privacy and Security Rules in connection...more

The First Circuit Rules On Materiality And Rule 9(b) In Two FCA Opinions

On November 22, 2016, the United States Court of Appeals for the First Circuit issued two False Claims Act (FCA) opinions in the continuing debate over the parameters of the FCA. In United States ex. rel. Escobar et al. v....more

House Files Motion to Delay Affordable Care Act Suit in Light of Change in Administration

On November 21, 2016, the U.S. House of Representatives filed a motion with the D.C. Court of Appeals requesting a temporary hold on briefing in U.S. House of Representatives v. Burwell as a result of Donald Trump’s election...more

House v. Burwell: The Obama Administration’s Final Brief?

The Department of Justice (DOJ) has filed its response to the motion filed on behalf of the U.S. House of Representatives (House) seeking to put the lawsuit challenging the Affordable Care Act’s (ACA’s) cost-sharing subsidies...more

FDA Issues Interim Response to AbbVie’s Citizen Petition on Interchangeability

About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the...more

Navigating the ACA in the Trump Era

On November 8, 2016, the future of the Patient Protection and Affordable Care Act (ACA) became more uncertain. Republicans in Congress have been working to repeal the ACA since it was passed in 2010, and now, with control of...more

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