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

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government…more
 /  Elections & Politics, Health, Science, Computers, & Technology

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

Welcome back everybody. The absence of Senator John McCain (AZ) – who is recovering at home from a craniotomy – has caused Senate Republicans to delay consideration of the Better Care Reconciliation Act (BCRA) previously…more
 /  Elections & Politics, Health, Insurance

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the…more
 /  Health, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies – July 2017

Welcome back everybody. Congress is back in session and facing a three - week work period before the August recess. There is plenty at stake these next few weeks as Senate Republicans and the White House pitch their Republican…more
 /  Elections & Politics, Health, Insurance

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Drug Makers Not Off the Hook as States Continue to Take Action to Control Drug Prices

Earlier this month, two states – Maryland and Nevada – passed legislation aimed at controlling drug prices. The two laws are being touted by proponents as decisive action against pharmaceutical manufacturers. Opponents note that…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Capitol Hill Update: Affordable Care Act Repeal on the Ropes?

The Senate bill to repeal the Affordable Care Act is currently being poured over by Senate Republicans and their staff, but the early prognosis for a vote this week is not good. Senate leadership had set a goal of voting on this…more
 /  Elections & Politics, Health, Insurance

Massachusetts House and Senate Tackle Marijuana Policy

On June 21st, 2017, after considering 118 amendments, the House passed sweeping legislation (H.3768) by a vote of 126 to 28 refining the laws governing the legalization of adult-use cannabis…more
 /  Commercial Law & Contracts, Elections & Politics, Taxation

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of…more
 /  Health, Science, Computers, & Technology

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing…more
 /  Constitutional Law, Consumer Protection, Criminal Law, Health, Science, Computers, & Technology

Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that the…more
 /  Civil Procedure, Consumer Protection, Elections & Politics, Health

Healthcare Weekly Preview from ML Strategies – June 2017 #3

Welcome back everybody. In general, this week insurers will submit their applications for participating in the Marketplace for 2018. After this we will begin to find out where the insurance deserts are and how much rates will…more
 /  Elections & Politics, Health, Insurance, Science, Computers, & Technology

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral…more
 /  Civil Procedure, Civil Remedies, Health, Intellectual Property, Science, Computers, & Technology

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities, these…more
 /  Consumer Protection, Privacy, Health, Science, Computers, & Technology

Healthcare Weekly Preview from ML Strategies – June 2017 #2

As the temperature rises in D.C. so does the temperature dial in the Senate. We’re entering week two of the June work period and the timeline for a Senate - version of the AHCA is still unclear. The work is ongoing, and while…more
 /  Elections & Politics, Health, Insurance
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