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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Akin Gump Strauss Hauer & Feld LLP ordered by Published Date Descending.
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1
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
2
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
3
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
4
CMS Issues Proposed Revisions To Open Payments/Sunshine Act Reporting Requirements
On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program("Open Payments")
United States
7 Aug 2019
5
Podcast: CBD, THC, FDA – What You Need To Know About Cannabis And Its Regulation
In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD.
United States
25 Jul 2019
6
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
7
Supreme Court Strengthens Protection Of Confidential Business Information Submitted To Federal Agencies
Food Marketing Institute v. Argus Leader Media, decided June 24, 2019 by the Supreme Court, substantially expands the Freedom of Information Act exemption for confidential business information.
United States
4 Jul 2019
8
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
9
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
10
What's New In Washington - June 2019
The summer season has arrived in Washington and things are heating up in the halls of  Congress. A number of high priority legislative proposals ranging from health care
United States
21 Jun 2019
11
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
12
The Federal Circuit Finds Jurisdiction Over The ITC's Decision Not To Institute An Investigation Under Section 337 And Explains When Claims Are Precluded By The FDCA
On May 1, 2019, a three-judge panel of the Court of Appeals for the Federal Circuit issued its long-awaited decision in Amarin Pharmaceuticals, Inc. v. ITC.
United States
22 May 2019
13
CMS Proposes Several Changes To Reimbursement For Transformative Medical Technologies
Currently, CMS bases new technology add-on payments on the cost to the hospital for the new medical technology.
United States
15 May 2019
14
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
15
New OMB Policy Will Likely Reduce Informal Agency Guidance
On April 11, 2019, acting director of the Office of Management and Budget (OMB) Russell Vought announced a policy for review
United States
7 May 2019
16
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
17
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
18
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
19
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
20
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
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