Consumer Finance Monitor Podcast Episode: A Look at the FTC’s Click-to-Cancel Rule, with James Kohm, Associate Director of Enforcement Division of the FTC’s Bureau of Consumer Protection
President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
On Tuesday June 16th, the U.S. Court of Appeals for the District of Columbia Circuit upheld a District Court decision that invalidated a Department of Health and Human Services (“HHS”) rule requiring pharmaceutical companies...more
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more
In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more
In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more
On July 8, 2019, in Merck & Co., Inc. v. United States Department of Health and Human Services, the US District Court for the District of Columbia invalidated a final rule pursuant to which pharmaceutical manufacturers would...more
In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more
CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would...more
On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule requiring that direct-to-consumer television advertisements for prescription drugs and biological products include certain pricing...more
U.S. Department of Health and Human Services Secretary Alex Azar announced this month the publication of a Final Rule from the Centers for Medicare & Medicaid Services (CMS) that will require television advertisements for...more
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more
The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. HOUSE TO VOTE ON BILL COMBINING ACA, DRUG PRICING PROVISIONS - The House is scheduled to vote on legislation...more
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television...more
The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more
On October 18, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would require direct-to-consumer (DTC) television advertisements for prescription drugs and biological products for which...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more