Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

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Health Industry Washington Watch

New IRS rulemaking impacts FCA settlement payment deductibility

By Rick Robinson & James F. Hennessy

February 25, 2021

Effective January 14, 2021, the Internal Revenue Service (“IRS”) implemented a final rule (the “Final Rule”) concerning the tax deductibility of settlement payments made to the government. This rulemaking followed a legislative update to the Internal Revenue Code of 1986 (“IRC”), which was implemented as part of the 2017 federal tax overhaul and specifically included a prohibition against deducting certain settlement payments. Relative to the IRS proposed regulations released in May 2020 (the “Proposed Rule”),…

Health Industry Washington Watch

FDA and USDA battle over regulating genetically engineered animals

By Cori Annapolen Goldberg, Sung Park, Taber Rueter & Yuxin Jin

February 23, 2021

A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing comment period, which ends on February 26, 2021. The proposed rule strips FDA’s jurisdiction over food-bearing GE livestock and places it within USDA’s purview, thereby granting USDA jurisdiction over pre-market review and post-market safety monitoring of such products. This significant change would create a less burdensome pathway for the regulatory approval…

Health Industry Washington Watch

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

By Andrew Lu

February 10, 2021

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic (or just looking to learn more), below is a brief primer on so-called “midnight regulations.” What exactly is a “midnight…

Health Industry Washington Watch

President Biden implements policies to expand access to health care and coverage

By Lauren Bentlage

February 8, 2021

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic. In addition to this Executive Order, the White House also announced President Biden’s Presidential Memorandum on Protecting Women’s Health at Home and Abroad (the “Presidential Memorandum”). The…

Health Industry Washington Watch

Department of Justice files statement of interest addressing the preemptive effect of the PREP Act

By Kristin Parker

January 21, 2021

On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes such claims removable from state court. However, it remains to be seen whether the views expressed in the statement of…

Health Industry Washington Watch

Congress’s approval of Competitive Health Insurance Reform Act (CHIRA) could mean significant antitrust changes for health insurers

By William J. Sheridan & Gregory Vose

December 29, 2020

The U.S. Senate recently voted unanimously to approve the Competitive Health Insurance Reform Act (Act), which the House of Representatives had already passed earlier in the fall. Currently, health insurers have federal antitrust immunity under the McCarran-Ferguson Act for state-regulated activity that constitutes the business of insurance. Should President Trump opt to sign CHIRA into law, however, that immunity would be largely repealed, although CHIRA does preserve some protections for health insurers. For a deeper…

Health Industry Washington Watch

Congress passes legislation impacting the Provider Relief Fund

By Caitlin Chambers

December 22, 2020

In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133. The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act. The President is expected to sign the legislation shortly. Of note, in the course of appropriating billions of additional dollars to combat COVID-19, division H, title II of the legislation alters certain requirements of the Provider Relief Fund…

Health Industry Washington Watch

HHS proposes important changes to key aspects of HIPAA Privacy Rule

By Ryan Bass, Nancy Halstead, Brad Rostolsky & Vicki Tankle

December 14, 2020

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes to key standards, definitions, and patient rights under the HIPAA Privacy Rule, which are geared toward promoting care coordination and…

Health Industry Washington Watch

Open for business in 2021

By Kelly Kearney & Andrew Lu

December 11, 2020

With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons safe. In an effort to resolve this seemingly open question, just this week, the National Institutes of Health (“NIH”) unveiled an innovative online mechanism that may give businesses the tools they need to choose a COVID-19 testing strategy for the year ahead. This mechanism, developed by a branch of the…

Health Industry Washington Watch

Long-Awaited issuance of Section 340B ADR final rule

By Joseph W. Metro & James Segroves

December 10, 2020

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B discounted product). The ACA directed the Secretary to issue such regulations within 180 days of the ACA’s enactment. The Secretary…

Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

Blog Authors

New IRS rulemaking impacts FCA settlement payment deductibility

FDA and USDA battle over regulating genetically engineered animals

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

President Biden implements policies to expand access to health care and coverage

Department of Justice files statement of interest addressing the preemptive effect of the PREP Act

Congress’s approval of Competitive Health Insurance Reform Act (CHIRA) could mean significant antitrust changes for health insurers

Congress passes legislation impacting the Provider Relief Fund

HHS proposes important changes to key aspects of HIPAA Privacy Rule

Open for business in 2021

Long-Awaited issuance of Section 340B ADR final rule

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