Articles and Blogs

Drug Pricing

OIG Finalizes Controversial Rule Updating AKS Discount Safe Harbor Applicable to Prescription Drug Rebates

[12/21/20]

Posted on December 21, 2020 in Health Law News

Published by: Hall Render

In the closing days of the Trump administration, OIG finalized a controversial rule (the “Final Rule”) to amend the discount safe harbor (“Discount Safe Harbor”) to the federal Anti-Kickback Statute (“AKS”), effectively changing the treatment of prescription drug rebates under the AKS. Beginning January 1, 2022,[1] certain reductions in price or other remuneration from... READ MORE

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Assessing the Impact of the New Drug Pricing Executive Orders

[07/31/20]

Posted on July 31, 2020 in Health Law News

Published by: Hall Render

On July 24, 2020, President Trump announced four Executive Orders (“Executive Orders”) characterized as focusing on lowering drug prices via various mechanisms. These Executive Orders, described in more detail below, include: (1) Executive Order on Access to Affordable Life-saving Medications; (2) Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3)... READ MORE

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Hall Render’s The Week in Washington – February 10, 2020

[02/10/20]

Posted on February 10, 2020 in Federal Advocacy

Published by: Hall Render

Surprise Billing Bonanza in the House On February 7, two House panels released measures aimed at fixing surprise medical bills. The House Ways and Means Committee and the House Education and Labor Committee plan to vote on their bills this week. Lawmakers are trying to move quickly as they hope to include surprise billing... READ MORE

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Hall Render’s This Week in Washington – November 22, 2019

[11/22/19]

Posted on November 22, 2019 in Federal Advocacy

Published by: Hall Render

Passage of Temporary Funding Bill Ends Potential Shutdown Just hours before the previous short-term agreement was set to expire on November 21, President Trump signed a bill funding the government through December 20. This measure gives Congress four additional weeks to reach a consensus on how to fund the government in FY 2020. The... READ MORE

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Hall Render’s This Week in Washington – September 27, 2019

[09/27/19]

Posted on September 27, 2019 in Federal Advocacy

Published by: Hall Render

Another Band-Aid: Congress Clears Continuing Resolution to Avoid Shutdown On Thursday, the Senate cleared legislation (H.R. 4378) by a vote of 82-15 to fund federal agencies and extend several health care-related programs through November 21. The vote on the continuing resolution followed House approval of the measure, which overwhelmingly passed the measure last week.... READ MORE

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Hall Render’s This Week in Washington – May 24, 2019

[05/24/19]

Posted on May 24, 2019 in Federal Advocacy

Published by: Hall Render

HELP Committee Leaders Release Draft Bill Targeting Health Care Priorities Senate Health, Education, Labor, and Pensions (“HELP”) committee leaders Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA) released a wide-ranging draft bill addressing health care issues such as surprise medical billing, prescription drug costs and urgent public health concerns. The proposal is separated into... READ MORE

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Hall Render’s This Week in Washington – May 17, 2019

[05/17/19]

Posted on May 17, 2019 in Health Law News

Published by: Hall Render

Lawmakers Seriously Pursuing “Surprise Medical Bill” Fix Continuing the bipartisan interest in addressing the issue of surprise medical billing, also known as balance billing, a group of bipartisan senators led by Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH) introduced legislation on Thursday. The legislation states that providers would be prohibited from balance billing... READ MORE

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Hall Render’s This Week in Washington – March 8, 2019

[03/08/19]

Posted on March 8, 2019 in Federal Advocacy

Published by: Hall Render

Congress Tackles Health-Related Issues in Multiple Hearings This Week Congress looked at many health policy issues in a week jam-packed with hearings. Continuing Congress’s probe into drug pricing, the House Ways and Means Health Subcommittee held a hearing on promoting competition to lower Medicare prescription drug costs. While lawmakers questioned whether the drug industry... READ MORE

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Hall Render’s This Week in Washington – February 1, 2019

[02/01/19]

Posted on February 1, 2019 in Federal Advocacy

Published by: Hall Render

HHS Previews 2019 Regulatory Agenda At a symposium on Tuesday, Deputy HHS Secretary Eric Hargan and CMS Administrator Seema Verma outlined the administration’s health care strategy for 2019, which includes advancing the use of technology, adjusting payments in rural areas and testing new ways to reward high-quality care and reforms to the Stark and... READ MORE

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Discount Disruption: PBM Rebate Protection May Be Removed, New Safe Harbors Combat Increasing Drug Costs

[02/01/19]

Posted on February 1, 2019 in Health Law News

Published by: Hall Render

On January 31, 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a proposed rule that, if finalized, would eliminate Anti-Kickback Statute (“AKS”) safe harbor protection for prescription drug rebates paid by manufacturers to pharmacy benefit managers (“PBMs”), Medicare Part D plans and Medicaid managed care organizations (“Proposed Rule”).... READ MORE

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