Regulatory Transactions

From: The Hill

BY NATHANIEL WEIXEL

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In a letter to Office of Management and Budget (OMB) Director Mick Mulvaney, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) and Senate Finance Committee Chairman Orrin Hatch (R-Utah) said they want a full analysis of a pending proposed rule regarding prescription drug rebates.

“The publicly available title of the rule indicates that the action contemplated could be significant in scope, with the potential to dramatically change the process by which prescription drugs are purchased within the supply chain,” Walden and Hatch wrote.

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Editor’s Note: Cross-posted from FISMA Focus/Federal Cyber Security.

From: FCW

By Mark Rockwell

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The work to get the RMF completed includes discussions with the White House’s Office of Information and Regulatory Affairs on the privacy additions, Ross said in remarks after a panel at FCW’s Aug. 9 Cybersecurity Summit.

Those discussions with OIRA, he said, are important because the latest version of the RMF will cover a number of critical areas, including supply chain and systems engineering but also privacy.

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From: BNA

By Brian Broderick

A new Medicaid rule affecting how managed care plans enroll doctors, hospitals, and other health-care providers is on the way from the Trump administration.

The White House Office of Management and Budget started review Aug. 3 of the proposal on managed care provider enrollments and terminations, based on a recent OMB posting at reginfo.gov. Details aren’t yet available on what’s in the proposal from the Centers for Medicare & Medicaid Services, but an industry group and a Medicaid policy attorney told Bloomberg Law they’re watching to see how the measure could affect Medicaid managed care, especially whether the CMS will allow more flexibility to industry.

Editor’s Note:  See also Canada and United States sign Memorandum of Understanding for regulatory cooperation.

From: KamloopsMatters.com

OTTAWA — Canada will review the joint vehicle emissions standards it has with the United States before it decides what to do about the U.S.’s plan to weaken those standards in the coming years.

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“The reality is because we have always followed what the U.S. has done it makes sense to see what comes out of the other end of the U.S. regulatory review process,” said David Adams, president of Global Automakers of Canada

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From: Husch Blackwell

By Kirt Salmon

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Direct and Indirect Remuneration

In NASP’s view, pharmacy benefit managers (PBMs) must better align their incentives with the ultimate payer – the consumer.  The association emphasizes its support for previous CMS proposals that address pharmacy price concessions, otherwise known as DIR (direct and indirect remuneration) and post-adjudication fees. The collection of these fees, which may be assessed months after claims are submitted and reimbursed, can provide an incentive by a PBM or plan sponsor for higher drug list prices and higher rebates according to NASP.  As a result, this practice creates uncertainty for specialty pharmacies and can threaten the pharmacies’ ability to provide high-touch services that are essential for optimal clinical outcomes for patients with complex health conditions.

From: Steptoe & Johnson LLP

Section 199A Proposed Regulations at OMB for Review: The computational package of section 199A proposed regulations are pending review at the Office of Information and Regulatory Affairs of the Office of Management and Budget. Section 199A, enacted by P.L. 115-97, allows a 20 percent deduction for certain pass-through owners, subject to certain limitations.

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From: The Hill

By Nathaniel Weixel

Executives at Eli Lilly, one of the nation’s largest pharmaceutical companies, are denouncing the Trump administration’s proposal to consider ways to import prescription drugs from other countries.

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Azar has said he thinks rebates give an incentive for higher drug prices, since both the PBM and drug company get a cut. A proposal that would remove certain legal protections around rebates is currently under review by the White House Office of Management and Budget.

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From: Reed Smith

On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.” This proposed rule, if released, appears to follow through on various statements made by HHS Secretary Azar suggesting that safe harbor protection under the Federal Anti-Kickback Statute should be removed for prescription drug rebates—a potential action on which HHS requested comment in the Administration’s Drug Pricing Blueprint.

From: FierceHealthcare

by Paige Minemyer

The Trump administration is considering a proposal to overhaul safe harbor protections for pharmaceutical company rebates, a plan that could lead to a significant shift in how drug prices are determined.

The Office of Management and Budget is reviewing a proposed rule from the Department of Health and Human Services on the matter. Details on how exactly HHS wants to rethink safe harbors are scant, as the rule will not be released publicly until OMB signs off on it.

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From: WorkBoat

By Pamela Glass

The Staten Island Ferry Guy V. Molinari. The Passenger Vessel Association recommends the Coast Guard exempt large passenger terminals from the TWIC reader requirement. Staten Island Ferry photo.

The passenger vessel industry has weighed in with a list of suggestions to the federal government on federal regulations that should be dropped or revised.

In a letter to the Office of Information and Regulatory Affairs (OIRA) dated July 16, the Passenger Vessel Association outlined federal policies and rules that are hampering operations of U.S.-flagged passenger vessels, including dinner cruise vessels, sightseeing excursion boats, and car and passenger ferries.