Regulatory Transactions

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.

From: Fairbanks Daily News-Miner

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It was in the final week of the Obama administration that the Interior Department’s then-solicitor general, Hilary C. Tompkins, announced that a 1936 action by Congress to extend a provision of the Indian Reorganization Act to Alaska “provides specific authority for the secretary (of Interior) to take Alaska lands into trust.” Ms. Tompkins also determined that the authority was not limited by a U.S. Supreme Court decision on the subject and that neither the Alaska Native Claims Settlement Act of 1971 nor the Federal Land Policy and Management Act “expressly or impliedly repeal that authority.”

From: JD Supra

Karen Bennett, Christopher Clare, Amanda Tharpe, Kenneth von Schaumburg

The White House Council on Environmental Quality (“CEQ”) has issued an Advanced Notice of Proposed Rulemaking (“ANPRM”) providing an exceptional opportunity for stakeholders to participate in improving the federal National Environmental Policy Act (“NEPA”) review process.  The ANPRM, entitled “Update to the Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act” (“NEPA”), was issued on June 20, 2018 pursuant to Executive Order 13807, “Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects” (“E.O. 13807”).  E.O. 13807 directs CEQ to suggest actions to modernize the federal environmental review process and was one of several steps taken by the Trump Administration aimed at streamlining an often burdensome and lengthy regulatory review process.  Comments are due by July 20, 2018.