FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

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FDA Law Blog

NOVEMBER 16, 2021

First, section 90006 imposes a moratorium on HHS’s implementation of an HHS OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D plans and Medicaid Managed Care plans (or their PBMs).

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ClimateChange-ClimateLaw

AUGUST 8, 2023

Scope 3 Emissions SB 253 would direct CARB to develop standards for GHG emissions reporting by January 1, 2025, with covered entities then required to begin annual reports following these standards in 2026 (for scope 1 and scope 2 GHG emissions) and in 2027 (for scope 3 emissions). [21]

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FDA Law Blog

AUGUST 3, 2021

The rebate rule significantly narrows the anti-kickback statute (AKS) safe harbor for discounts, so that it excludes manufacturer rebates to Medicare Part D plans (or their pharmacy benefits managers (PBMs)). We previously explained the rebate rule and its likely impact on patients and payors here. See 42 C.F.R. 1001.952(h).

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FDA Law Blog

SEPTEMBER 14, 2021

in general (the statute does not indicate that these lists would be mutually exclusive). Since manufacturers do not calculate or submit any prices under Part D, the statute borrows the AMP submitted under the Medicaid Drug Rebate Program to develop an “Annual Manufacturer Price” for both the rebate calculation year and a baseline year.

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ClimateChange-ClimateLaw

MARCH 13, 2023

In its legislative findings, which remain in air quality statutes today , Congress justified air pollution regulation because “the growth of the amount and complexity of air pollution brought about by urbanization, industrial development, and the increasing use of motor vehicles, has resulted in mounting dangers to the public health and welfare.”

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Customs & International Trade Law

JANUARY 10, 2025

Consumer Product Safety Commission (CPSC) The CPSC published a notice announcing that the new eFiling requirements will be effective in stages in 2026 and 2027. trade representative to impose duties in response to retaliatory measures from China President-elect Donald Trump is considering putting the U.S.

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FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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ClimateChange-ClimateLaw

MARCH 9, 2021

in which the Ninth Circuit affirmed a district court finding that the federal-officer removal statute did not provide jurisdiction. With respect to federal-officer jurisdiction, the district court noted that this case was similar to County of San Mateo v. Chevron Corp.

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ClimateChange-ClimateLaw

APRIL 9, 2021

In Minnesota, the district court granted the State of Minnesota’s motion to remand its case, which asserts state law claims under common law and consumer protection statutes. s consumer protection statute. On March 26, 2021, the court denied Exxon’s emergency motion for a temporary stay of the remand order.

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Above The Law

APRIL 7, 2025

They also develop and present CLEs, interpret statutes and rules relating to legal ethics, draft legal ethics opinions and rule amendments, and provide counsel and support to assigned committees, task forces and work groups. 2026 December 2-4. Learn more and register here. August 7-9. Learn more here. Learn more here. Announcements?

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ClimateChange-ClimateLaw

NOVEMBER 13, 2024

These tax credits are enshrined in statute, as is the right to claim them by elective pay. Still, under the Trump administration, Treasury may start those rulemaking processes relatively quickly and get at least a few rules amended by sometime in 2026.

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