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Key Takeaways From CMS's Final Rule Requiring The Disclosure Of Affiliates During Provider Enrollment
The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the "Final Rule") that is designed to increase ...
United States
19 Sep 2019
Commissioner Bob Adler Elected Vice-Chairman Of The CPSC, Making Him Acting Chairman Of The Agency
Late this afternoon it was confirmed that Commissioner Bob Adler was elected Vice-Chairman of the CPSC.
United States
19 Sep 2019
Eleventh Circuit Rules In AseraCare Case That Disagreements In Clinical Judgment, Without Objective Falsity, Do Not Prove Fraud Under The FCA
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc..
United States
16 Sep 2019
#CCPA Legislative Update: "And The Days Dwindle Down … To A Precious Few…." (September Song, Kurt Weill)
The California 2019 legislative session closes on Friday, and thus all bills must be finalized to move to the Governor's desk for signature. That means that all CCPA pending amendments
United States
13 Sep 2019
Tech CEOs To Congress: Please Pass Federal Privacy Law
51 tech company CEOs today signed and sent an open letter to Congress asking for help to hold off and supersede the rising number of state privacy laws growing like weeds.
United States
12 Sep 2019
Incorporation By Reference Of A Commercial Contract's Arbitration Clause Can Bind A Non-Signatory Performance Bond Surety
Heads up, sureties! (And all other contracting parties.) Incorporation by reference of the terms of one agreement into another is a classical common law basis for binding
United States
11 Sep 2019
California Legislature Working Through Data Privacy Amendments
As we reported here, the final days of the 2019 California legislative session are winding down, with important amendments to the California Consumer Privacy Act (CCPA) still pending.
United States
10 Sep 2019
The Bubbler – We'll Wake You Up When September Ends
We know August was exhausting for employers – New York, New Jersey, Maine, Colorado, and yes, even Alabama
United States
9 Sep 2019
Processing Delays Expected To Continue For All Trusted Traveler Program Applications
According to U.S. Customs and Border Protection (CBP), the extended government shutdown earlier this year, as well as the ongoing crisis at the southern border with Mexico
United States
6 Sep 2019
Changes To Preference Practices Under New Bankruptcy Law
On August 23, 2019, President Trump signed into law the "Small Business Reorganization Act of 2019."
United States
5 Sep 2019
Part 2 Proposed Rule Brings Clarity And Reduces Regulatory Burdens For Substance Use Disorder Providers, But Challenges Remain
On August 22, the Substance Abuse and Mental Health Services Administration ("SAMHSA") announced a new proposed rule (the "Proposed Rule") amending 42 CFR part 2
United States
4 Sep 2019
New Convention Aims To Make Mediated Settlements An Attractive Means Of Resolution Of International Disputes . . . But Will It?
The United States joined 45 other countries on August 7, 2019 as the initial signatories of the UN Convention on International Settlement Agreements Resulting from Mediation
United States
4 Sep 2019
Telemedicine Platform Recalled Over Failure To Obtain Pre-Market Clearance Or Approval From FDA
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc.
United States
30 Aug 2019
GAO Studies Use Of PBMs In Medicare Part D
GAO recently released a report analyzing the use of pharmacy benefit managers ("PBMs") and efforts to manage drug spending and use in the Medicare Part D program
United States
28 Aug 2019
HHS Drug Pricing Disclosure Rule: Chance At A Renewed Life Following District Court Appeal?
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court.
United States
28 Aug 2019
Facsimiles And Other Fossils: FTC Initiates Review To Update COPPA Rule To Keep Pace With Emerging And Connected Technology
They grow up so fast! A sentiment – and challenge – shared by parents and technologists alike. Just when you think you've finally figured it out, you blink, and they're unrecognizable.
United States
28 Aug 2019
Aaron Josephson Weighs In On Debate Over FDA Data Falsification Rule With FDA Week
Our ML Strategies colleague Aaron Josephson was quoted extensively in an August 16 FDA Week article (FDA Week is a focused newsletter from InsideHealthPolicy)
United States
27 Aug 2019
DOJ Seeks Dismissal Of FCA Qui Tam Case To Escape Onerous Discovery Obligations
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator's qui tam suit because of the defendant's burdensome discovery
United States
26 Aug 2019
Artificial Intelligence In The Employment Relationship: Friend Or Foe?
Artificial Intelligence ("AI") is no longer the stuff of sci-fi movies or alien invasions. The technology has permeated everyday life from Siri and Alexa to Facebook and Google.
United States
23 Aug 2019
PTAB Confirms (Again) That The AIA's "Enhanced Estoppel" Provision Applies To Concurrent IPR Proceedings
In a decision from the PTAB issued last week, the Board confirmed that the "enhanced estoppel" provision of 35 U.S.C. § 315(e)(1) applies to co-pending IPR proceedings when a final written decision issues in a first IPR.
United States
22 Aug 2019
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