Searching Content indexed under Healthcare by Akin Gump Strauss Hauer & Feld LLP ordered by Published Date Descending.
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Battle Lines Drawn With Release Of Speaker's Drug Pricing Plan
On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price negotiation and international reference pricing.
United States
8 Oct 2019
Podcast: DOJ's New Guidance On Evaluating Compliance Programs: What You Need To Know
In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department's recent guidance on evaluation of corporate compliance programs.
United States
20 Sep 2019
CMS Proposes New Payment Model For Radiation Oncology
On July 18, 2019, the CMS and the CMMI published a proposal to implement a new mandatory Medicare payment model in select geographic areas—the Radiation Oncology (RO) Model.
United States
13 Aug 2019
Drug Pricing And Surprise Billing: Recent Actions And Outlook
Recent months have seen a flurry of activity in Congress on prescription drug pricing and surprise medical bills as lawmakers seek to address rising consumer health care costs.
United States
9 Aug 2019
District Court Affirms FDA Policy On Compounding With Bulk Drug Substances—Bringing Much Needed Clarity For The Outsourcing Facility Industry
On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration's (FDA's) decision to exclude the bulk drug substance vasopressin
United States
8 Aug 2019
What's New In Washington - July 2019
If you missed the fireworks on Independence Day, don't worry because they will continue for the entire month of July on Capitol Hill.
United States
19 Jul 2019
Podcast: Mental Health & Well-Being In The Legal Industry
This episode debuts a series of conversations between Akin Gump chairperson Kim Koopersmith and thought leaders in and around the legal industry.
United States
4 Jul 2019
Three Years After Escobar: Lessons Learned Regarding Plaintiffs' Efforts To Neutralize Escobar And Opportunities This Practice Raises For Defendants
Approximately three years ago, a unanimous Supreme Court decided Universal Health Servs. v. United States ex rel. Escobar.
United States
3 Jul 2019
Checking In On FDA's Enforcement Discretion Policy For Laboratory Developed Tests
As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs),
United States
28 May 2019
Life Sciences Due Diligence: A Reference Guide For Your Life Sciences Corporate Transactions
These two discrete matters may not signal a new government enforcement strategy to hold private equity and venture capital investors liable under the False Claims Act,
United States
14 May 2019
A Client's Guide To FDA Recalls
The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff ...
United States
29 Apr 2019
FDA's AI White Paper: To Be Or Not To Be, That Is The Question
On April 2, the U.S. Food and Drug Administration published a long-awaited exploratory white paper proposing a framework for regulating artificial intelligence/machine learning -based software as a medical device.
United States
26 Apr 2019
Analyzing The Revised AdvaMed Code: Suggested Evaluation Checklist
Review the AdvaMed Code revisions with an eye towards other key fraud and abuse, transparency and compliance issues on the horizon: the expansion of the Sunshine Act and anticipated regulatory changes
United States
14 Mar 2019
FDA Finalizes Criteria, And First Two Exclusions, For Outsourcing Facility Compounding With Bulk Drug Substances
Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations
United States
13 Mar 2019
Deadline Approaching To Submit Comments On Potential Updates To HIPAA In Response To Agency Request For Information
There are less than two weeks left to submit comments regarding potential updates to the privacy, security and breach notification regulations adopted under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009.
United States
5 Feb 2019
OIG Approves Manufacturer Loaning Smartphones As Appropriate Patient Assistance To Support Digital Medicine
On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance ...
United States
5 Feb 2019
Federal Circuit Decision Clarifies When An ANDA Filer May Appeal An Adverse IPR Ruling
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board ...
United States
31 Jan 2019
AdvaMed Releases Updated Code Of Ethics On Interactions With Health Care Professionals
Revisions to the Code go into effect on January 1, 2020, giving companies nearly a year to review their compliance policies, training ...
United States
24 Jan 2019
The DQSA: Five Years In
November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law
United States
3 Dec 2018
What's New In Washington - September 2018
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30.
United States
5 Oct 2018
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