Mintz Levin - Health Law & Policy Matters

Contact
Share
Info
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

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not…more
 /  Communications & Media Law, Constitutional Law, Consumer Protection, Health, Science, Computers, & Technology

CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation…more
 /  Health, Science, Computers, & Technology

August 2017 Is Here – Will FDARA Get Done Soon?

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Holdout States Loosen Restrictions on Telemedicine but Obstacles Remain

A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority…more
 /  Health, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies – July 2017 #4

Following the dramatic conclusion of the failed vote on the repeal of the Affordable Care Act (ACA), it appears the Senate will pivot to other issues, namely the National Defense Authorization Act (NDAA). However, the…more
 /  Elections & Politics, Health, Insurance

The HIPAA “Wall of Shame” is Now Easier to Navigate

Last week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made…more
 /  Health, Privacy, Science, Computers, & Technology

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A common…more
 /  Health, Insurance

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

We head into the last week of July with the Findings of the Senate Parliamentarian in hand, who ruled late Friday that several provisions in the Better Care Reconciliation Act (BCRA) released on June 26th would be subject to the…more
 /  Elections & Politics, Health, Insurance

DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud…more
 /  Criminal Law, Health

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
Showing 1-15 of 1073 Results
/
View per page
Page: of 72
This profile may constitute attorney advertising. Prior results do not guarantee a similar outcome. Any correspondence with this profile holder does not constitute a client/attorney relationship. Neither the content on this profile nor transmissions between you and the profile holder through this profile are intended to provide legal or other advice or to create an attorney-client relationship.

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.