Searching Content indexed under Healthcare by Cooley LLP ordered by Published Date Descending.
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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
Q3 Government Settlements Round-Up: Life Sciences
Health regulatory news and issues.
United States
4 Oct 2019
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
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
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
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.
13 Sep 2019
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An applicant whose enrollment has been revoked twice will not be permitted to reenroll for up to 20 years.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
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
Administration Releases Drug Importation Plan But Implementation Questions Abound
Under the HHS plan, there would be two importation methods.
United States
2 Aug 2019
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
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
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
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
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
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
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
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
OIG Provides Strong Rebuke Of Pharmaceutical Free Drug Program
On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General issued Advisory Opinion No. 18-14 regarding a proposed free drug program ("Proposed Arrangement").
United States
27 Nov 2018
Federal Sunshine Act Reporting Requirements Expanded To Other Prescribers
Because this change applies to all data submitted on or after January 1, 2022, companies must begin collecting reportable data on January 1, 2021.
United States
9 Nov 2018
Agreements Involving Biosimilars Must Be Reported To FTC And DOJ Under New Law
Consultation with antitrust counsel, both in structuring settlement agreements and in submitting filings, is therefore advisable.
United States
22 Oct 2018
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