Mintz Levin - Health Law & Policy Matters

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Firm Profile: Mintz Levin
701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States
Phone: 202-434-7324
Fax: 202-434-7400
Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Locations
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys
400+ Attorneys

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the…more
 /  Health, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies – November 2017 #2

It’s all about tax reform in Congress. This week, the House will be working on the National Defense Authorization Act (NDAA) and advancing the Tax Cuts and Jobs Act, which will go before the House Rules Committee on Wednesday…more
 /  Elections & Politics, Health, Taxation

Latest OCR Cybersecurity Newsletter Tackles Mobile Devices

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) released its October Cybersecurity Newsletter last week with a focus on mobile devices. Given the amount of work conducted on mobile devices (odds…more
 /  Health, Privacy

Health Care Weekly Preview from ML Strategies – November 2017

Following House passage of a CHIP reauthorization package, the bill heads to the Senate where it faces an uncertain path forward. First, there’s no indication the Senate is ready to give the House package real consideration. The…more
 /  Elections & Politics, Health, Taxation

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Building a Health App? Part 7: Commercialization and Strategic Partners

Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and…more
 /  Commercial Law & Contracts, Health, Intellectual Property, Science, Computers, & Technology

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th…more
 /  Health, Science, Computers, & Technology

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging…more
 /  Antitrust & Trade Regulation, Business Organizations, Commercial Law & Contracts, Health, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies - October 2017 #4

As the calendar turns to November, pressure continues to grow in Congress to pass a CHIP package. The relevant House and Senate committees each passed different versions of CHIP, and finding payfors continue to be the main…more
 /  Elections & Politics, Health

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)…more
 /  Communications & Media Law, Constitutional Law, Consumer Protection, Health, Science, Computers, & Technology

Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations

Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These…more
 /  Commercial Law & Contracts, Consumer Protection, Health, Privacy, Science, Computers, & Technology

Special Needs Plans: A Minibus Rider

As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health…more
 /  Elections & Politics, Health

Health Care Weekly Preview from ML Strategies - October 2017 #3

With 24 bipartisan cosponsors in the Senate, the emerging Alexander-Murray stabilization package is a significant step forward in the health reform debate. However, after months of dominating the airwaves, health care is now…more
 /  Elections & Politics, Health

Building a Health App? Part 5: Contracting for Health App Construction

As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties. For example,…more
 /  Commercial Law & Contracts, Health, Intellectual Property, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies - October 2017 #2

The Administration’s actions last week to disrupt the Affordable Care Act (ACA) marks a new chapter in the Republican repeal effort. The cost-sharing reductions (CSRs) that plans receive to cover lower-income individuals will no…more
 /  Health
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