July 18, 2019

Facebook’s Crypto Woes Deepen as Mnuchin Joins Parade of Critics

From: Bloomberg

  • Treasury Secretary says he has serious concerns about coin
  • Facebook executive says crypto won’t launch without approvals

By  and 

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Marcus said the token won’t launch until regulatory questions are fully addressed and he added that Facebook will get “appropriate approvals.” He said the coin isn’t isn’t intended to compete with countries’ sovereign currencies and won’t interfere with central banks on monetary policy.

July 10, 2019

How FDA is Regulating E-Cigarettes

From: FDA

By: Ned Sharpless, M.D., Acting Commissioner

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Under the PMTA pathway, FDA evaluates a new tobacco product based on whether it is appropriate for the protection of the public health. Scientific evaluation considers the risks and benefits of the product for the whole population, including users and non-users. These data should show the increased or decreased likelihood that current tobacco users will stop using certain products, as well as the increased or decreased likelihood that non-users will start using the products.

Before and After OIRA Review Versions Provided for Proposed GILTI Regs

From: Taxnotes

Citations: REG-101828-19

SUMMARY BY TAX ANALYSTSThe following text is an unofficial redline comparison of proposed regulations (REG-101828-19) that provide guidance on stock ownership rules and global intangible low-taxed income and a draft versionof the regs before they were submitted for review by the White House Office of Information and Regulatory Affairs.

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 tax1

tax2

See complete document (paywall)

June 27, 2019

The Trump administration is quietly helping people get kidneys

From: Vox

Two new rules could make sure more kidneys go to recipients who need them.

June 21, 2019

Key Trump proposal to lower drug prices takes step forward

From: The Hill

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The Department of Health and Human Services (HHS) sent to the White House for review a proposal to lower certain drug prices in Medicare by linking them to the lower prices paid in other countries, an idea called the international pricing index.

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It is unclear how long the process of White House review will take, and whether the White House will seek to make significant changes to the proposal

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June 17, 2019

Federal Government Violated The Law In Marijuana Scheduling Evaluation, Group Says

Editor’s Note: For a history of the use of the DQA to seek relief from federal dissemination of inaccurate information concerning the medical use of cannabis, see Americans for Safe Access Data Quality Act Briefs and Replies. To see the power of the DQA to change a DEA scheduling decision, see Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status.

From: Marijuana Moment

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June 11, 2019

OMB Reviewing OIG Proposed Rule Amending Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

From: Lexology

Elizabeth B. Carder-Thompson and Debra A. McCurdy | Reed Smith LLP

The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care. The proposed rule presumably builds on the related request for information (RFI) on this topic issued by the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) in August 2018. As discussed in a Reed Smith client alert, the RFI sought information on, among other things, changes needed in current safe harbors and beneficiary inducement CMPs to promote beneficial care coordination, patient engagement, and value-based arrangements.

May 29, 2019

OMB begins review of FMCSA proposal on hours-of-service rules for agricultural commodities

From: Safety + Health

Washington — The Federal Motor Carrier Safety Administration on May 17 submitted for review to the White House Office of Management and Budget an advance notice of proposed rulemakingintended to help the agency assess whether to clarify the definitions of “agricultural commodity” or “livestock” in FMCSA’s hours-of-service regulations for commercial truck drivers.

Currently, federal regulations offer an HOS exemption for drivers who transport livestock and other agricultural commodities within a radius of 150 air miles.

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May 24, 2019

DOL to revisit fiduciary rule by December

Editor’s Note: See also  The Future Of The Fiduciary Rule Is In OIRA’s Hands.

From: Pensions & Investments

By Hazel Bradford

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The agenda, published by the Office of Management and Budget’s Office of Information and Regulatory Affairs for all federal agencies, projects a December release date for advanced notice of proposed rule-making, the first step in issuing new rules.

DOL issued a revised fiduciary rule in April 2016 to replace one from 1975, but it was vacated by the 5th U.S. Circuit Court of Appeals in New Orleans in March 2018, on the grounds that it represented regulatory overreach. “The department is considering regulatory options in light of the 5th Circuit opinion,” the OMB notice said.

May 21, 2019

Hours of service proposal for ag haulers sent to White House

From: Land Line

By Mark Schremmer, Land Line associate editor

A pre-rule that could affect the hours-of-service regulations for haulers of agricultural commodities has been sent to the White House Office of Management and Budget for review.

According to the Office of Information and Regulatory Affairs, the ag haulers pre-rule was received on May 17 and is pending review.

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