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CMS Takes Action Against Network Transparency While New Jersey Legislation Hits a Snag

February 10, 2016 | Blog

Just as the Centers for Medicare & Medicaid Services (CMS) began holding federal health care plans accountable for their provider network transparency obligations, the New Jersey legislature stalled in its bid to pass a law that would require hospitals and physicians to disclose whether they are in or out-of-network with a patient’s insurance plan before providing treatment. 
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Positive FDA Advisory Committee Vote for First Monoclonal Antibody Biosimilar - But Will Patent Dispute Delay Launch?

February 10, 2016 | Blog | By Joanne Hawana

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech.
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OMB Finalizes Review of 60-Day Overpayment Rule

February 9, 2016 | Blog | By Brian Dunphy

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule”).  As a result, the final 60-day rule will likely be published soon.
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Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

February 4, 2016 | Blog

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing. 
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Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

February 3, 2016 | Blog | By Alexander Hecht

Today, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under Medicare.
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ICYMI: Biosimilars and FDA Regulatory Webinar

February 2, 2016 | Blog | By Joe Rutkowski

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation.
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FDA Releases Draft Guidance for Medical Device Cybersecurity

February 1, 2016 | Blog

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called "Internet of Things." Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked.
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The Challenge of Non-Interference

January 29, 2016 | Blog

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example.  Acme Drug Company brings a drug to the market as a single source innovator. 
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CBO’s Budget Forecast and the Silver Tsunami

January 28, 2016 | Blog

This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today to more than 80 million by 2036.
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Massachusetts Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report

January 27, 2016 | Blog | By Daria Niewenhous

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings.
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Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

January 26, 2016 | Blog | By Joanne Hawana

FDA lacks the appropriate data to effectively conduct post market surveillance and safety tracking activities, according to two reports released earlier this month.
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Senate Working Group Considers Telehealth Policy Changes to Medicare

January 21, 2016 | Blog | By Carrie Roll

In keeping with the boom of telehealth legislation introduced last year at both the state and federal level, the Senate Finance Committee is considering several policy changes that, if ultimately enacted, could make telehealth the preferred method of care delivery for millions of Medicare beneficiaries living with chronic conditions.
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ML Strategies Publishes Washington Outlook for 2016

January 20, 2016 | Blog | By Bridgette Keller

Earlier today, my colleagues at ML Strategies published the Washington Outlook for 2016, offering their insights about what we might expect from Capitol Hill and the Administration in the coming year.
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Employment Matters: “Wrap” Documents for Employee Health and Welfare Plans

January 15, 2016 | Blog

On Tuesday, our colleague, Patricia Moran, discussed the importance of employers using “wrap” documents for certain health and welfare plans on Mintz Levin’s Employment Matters Blog.
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Health Care Enforcement Report: A Look Back at 2015 and a Forecast for 2016

January 11, 2016 | Blog | By Brian Dunphy

My colleagues Hope Foster, Larry Freedman, and Bridget Rohde, members of Mintz Levin’s Health Care Enforcement Defense group, recently published a report surveying health care enforcement trends and developments in 2015 and forecasting what these developments herald for 2016.
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A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

January 8, 2016 | Blog | By Joseph Lipchitz

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion.
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Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

January 7, 2016 | Blog | By Lauren Moldawer, Daria Niewenhous

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites. Federal law already requires that those “engaged in the business” of selling guns must have a Federal Firearms License (FFL) and conduct background checks at the time of every purchase.
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The Managed Care Industry – 2015 Year in Review

January 6, 2016 | Blog | By Bridgette Keller

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016.
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Massachusetts Uses Telemedicine Technology to Expand Access to Behavioral Health Services

January 6, 2016 | Blog | By Ellen Janos

Recognizing the importance of telemedicine, a committee of the Massachusetts Health Policy Commission recently voted on a grant program that will award up to $500,000 each for two telemedicine pilots that target the behavioral health needs of children, homebound seniors, and people with substance use disorders.
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Upcoming Webinar and Report - Health Care Enforcement in 2016

December 30, 2015 | Blog

As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016.
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