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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Cooley LLP ordered by Published Date Descending.
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1
Mylan Settles SEC Charges For Disclosure And Accounting Failures Arising Out Of DOJ Investigation
At the end of September, the SEC announced that it had filed a complaint in federal court charging pharma Mylan N.V. with failing to timely disclose in its financial statements the "reasonably possible" material losses ...
United States
16 Oct 2019
2
HHS Releases Long-Awaited Proposed Rules Related To AKS, Stark, CMP Laws For Value-Based And Coordinated Care Arrangements
The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to "modernize and clarify" federal laws relevant to value-based and patient
United States
16 Oct 2019
3
Q3 Government Settlements Round-Up: Life Sciences
Health regulatory news and issues.
United States
4 Oct 2019
4
OIG Report On Reasonable Assumptions In Manufacturer Reporting
Last week the OIG published a report titled "Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices" that reviewed the use of assumptions made by a sample of drug manufacturers ...
United States
30 Sep 2019
5
OIG Publishes Advisory Opinion On An Arrangement Involving An Excluded Individual
An independent appraisal obtained by the requestor and company would determine the purchase price to be paid by the requestor.
United States
26 Sep 2019
6
OIG Work Plan Round-up: 12 New Items Added For August 2019 Including Medicare DRG, Diabetes Testing Strips, Telehealth Services
The Office of Inspector General (OIG) for Health and Human Services (HHS) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG.
United States
25 Sep 2019
7
Brazil's Data Protection Law Moves Forward
The final version of Brazil's data protection law, Lei Geral de Proteção de Dados (LGPD), was approved by the Brazilian Federal Senate in May 2019 and sanctioned by President Jair Bolsonaro in July.
Brazil
13 Sep 2019
8
Final Rule Issued By CMS Re: New Enforcement Authorities To Reduce Criminal Behavior In Medicare, Medicaid And CHIP
An applicant whose enrollment has been revoked twice will not be permitted to reenroll for up to 20 years.
United States
11 Sep 2019
9
Proposed Rule Issued By CMS Re: Expansion Of Open Payments Reporting
Manufacturers also should consider potential system enhancements and other changes that will be necessary to implement these updates if the Proposed Rule is finalized by CMS.
United States
6 Aug 2019
10
Administration Releases Drug Importation Plan But Implementation Questions Abound
Under the HHS plan, there would be two importation methods.
United States
2 Aug 2019
11
FCC Makes $100 Million Available For Telehealth Experiments
At its July 10 meeting, the FCC adopted a Notice of Proposed Rulemaking, which proposes the creation of a three-year "Connected Care Pilot program."
United States
15 Jul 2019
12
White House Withdraws Rebate Rule
Earlier this morning, the White House announced that they were scrapping a proposed rule that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for ...
United States
15 Jul 2019
13
No Surprise! – Drug Pricing Legislation Picking Up Steam
Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress.
United States
21 Jun 2019
14
Nevada DHHS Releases 2019 Drug Transparency Report
The Nevada Department of Health and Human Services (DHHS) released today its 2019 Drug Transparency Report in connection with the state law requiring transparency related to essential diabetes drugs.
United States
4 Jun 2019
15
Medicare For All Unveiled In House. Some Things Old, Some Things New, But Much Left To Do
Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.
United States
18 Mar 2019
16
New Bill To Exempt Low-Revenue Companies From SOX 404(B) - Have We Reached An Inflection Point?
That's because, in 2016, the House passed the Fostering Innovation Act of 2015—the very same bill.
United States
15 Feb 2019
17
HHS Proposed Rule Would Remove Safe Harbor Protection For Certain Discounts
If implemented, the Proposed Rule will take effect on January 1, 2020.
United States
7 Feb 2019
18
AdvaMed Code Of Ethics Updated Effective January 1, 2020
The Advanced Medical Technology Association (AdvaMed) announced earlier this month the availability of an updated Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code).
United States
4 Feb 2019
19
2018 Farm Bill Enacted With Important Provisions For Plant IP And Cannabis-Related Business
The $867 billion farm bill ("Agriculture Improvement Act" – House Res. 2) was signed into law by the president on December 20.
United States
23 Jan 2019
20
The Department Of Health And Human Services Issues Guidelines On GDPR's Territorial Scope
We have outlined key information about the five cybersecurity threats and ten cybersecurity practices presented in the Cybersecurity Guidelines below.
United States
15 Jan 2019
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