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

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In addition…more
 /  Health

CMS Guidance on Work Requirements for Medicaid Eligibility

Today (January 11, 2018), CMS released a Letter to Medicaid Directors outlining guidance that work requirements can be used as a basis for eligibility for certain adult Medicaid beneficiaries through 1115 waivers. Medicaid…more
 /  Health, Labor & Employment Law

Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in…more
 /  Elections & Politics, Health

OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of…more
 /  Health

ML Strategies – 2018 Health Care Preview

Happy New Year!?! 2017 was an eventful year for health care, and now we can all sit back and relax with very little concern that major health policy will be on the table in 2018. Right? Why must Speaker Ryan ruin our…more
 /  Elections & Politics, Health

Sessions Memo Resets Federal Marijuana Enforcement Policy

The U. S. Department of Justice (DOJ) issued a memo dated January 4, 2018 regarding federal marijuana enforcement policy, directing all U.S. Attorneys to enforce the laws enacted by Congress and to follow well-established…more
 /  Commercial Law & Contracts, Criminal Law, Elections & Politics

Health Care Weekly Preview from ML Strategies - January 2018

Happy New Year and welcome to 2018. We find ourselves in a familiar position as Congress has until January 19th to pass a government - funding bill. CHIP and the extenders remain in limbo, and Republicans and Democrats are…more
 /  Health

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related to…more
 /  Health, Science, Computers, & Technology

Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance that…more
 /  Consumer Protection, Health, Privacy, Science, Computers, & Technology

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug…more
 /  Health, International Law & Trade, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies – December 2017 #3

Republicans enter this week on target to pass a sweeping tax reform package after securing support from Senators Corker (TN) and Rubio (FL). Additionally Susan Collins (ME) applauded the “inclusion of multiple amendments,” but…more
 /  Elections & Politics, Health

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For those…more
 /  Antitrust & Trade Regulation, Health, Science, Computers, & Technology

Proposed Law Would Criminalize Failures to Report Data Breaches

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax,…more
 /  Consumer Protection, Elections & Politics, Health, Privacy, Science, Computers, & Technology

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

This week, Republican efforts to pass a tax reform package is likely to come to a head with the clock running out on 2017. The Conference Committee will meet on Wednesday in hopes of putting the finishing touches on a bill that…more
 /  Elections & Politics, Health, Taxation

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a…more
 /  Health, Science, Computers, & Technology
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