The Biden administration has begun to review all of Trump’s last-minute regulations after President Biden immediately froze all regulatory action that has yet to take effect.

‍Among the regulations the new administration is reviewing, is former President Trump’s rebate rule and his rule on insulin and epinephrine 340B discounts. The Biden administration has decided to let HHS officials decide if either of the final drug pricing rules should be delayed while they are being reviewed. To read the full article, click here.

• ‍HHS decided to freeze former President Trump’s 340B drug discount rule. The rule would have gone into effect on January 22, 2021 but has now been postponed until March 22, 2021. If HHS officials decide to review the rule further and open it back up to the rulemaking processes, than it may be postponed even further. To review the updated rule, click here.‍

• The Biden administration has not yet delayed the drug rebate rule. The administration has until Friday (January 29) to freeze the final rule from being implemented. The rule, which passes rebates to patients at the pharmacy, has had little to no support from anyone outside former President Trump’s team and drug manufacturers. The rule is expected to raise premiums and therefore government spending. To read the full article, click here.

Biden’s Department of Health and Human Services faces multiple lawsuits and challenges left behind by the Trump administration.

‍Notably, PhRMA and other industry groups have filed lawsuits against HHS regarding most-favored-nation rule. The rule has been blocked in court, giving the Biden administration a chance to revitalize the idea without implementing his rule. Similarly, PhRMA has a current lawsuit against HHS to block the rule allowing the importation of certain drugs from Canada. Biden’s administration also faces possible lawsuits over 340B discounts, which HHS Secretary Becerra has actively worked in favor of protecting already. To read the full article, click here.

Researchers from Yale School of Medicine and UCSF School of Medicine analyzed trends in within-class changes in the average wholesale prices for brand name medications from 2015-2020.

‍The study only focused on brand-name medications used for chronic conditions that were available before 2018. They found a high correlation between average wholesale prices among the five classes used to treat chronic conditions that have multiple brand-name drugs on the market from 2015-2020. This shows that although there should be competition among the brand-name drugs analyzed, there is little price competition among them. To read the complete study, click here.

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CIDSA Experts in the News

Ge Bai spoke with Washington Post reporters on new hospital regulations that are intended to increase pricing transparency and limit surprise billing. She was quoted saying that “hospitals are playing a hide-and-seek game, even with this regulation, most of them are not being fully transparent.” To read the full article, click here.

Sean Dickson was quoted in a recent Inside Health Policy article on Medicare Part D patient protections in response to a CMS demonstration that addresses protected drug classes and the requirement that insurers must cover a minimum of two drugs in each class. Dickson commented that eliminating the protections will not necessarily save a significant amount of money. To read the entire article, click here.

Both Stacie Dusetzina and Rachel Sachs were quoted in a Fierce Pharma article on the drug pricing opportunities in the Biden administration. Sachs acknowledged that while it may be difficult to prioritize drug pricing at the moment, there is significant potential for Medicare Part D reforms and penalties for extreme price hikes with the new change in Senate leadership. Dusetzina commented that while Trump’s executive orders will likely be overturned, his efforts abroad did work to “normalize the concept that there are evaluations to help with negotiations” to lower drug prices. To read the full article, click here.

Rachel Sachs commented on Trump’s attempt to lower drug prices in a recent LA Times column. She called the last administration’s effort “a rhetorical success but practical failure.” With regards to the most-favored-nation and rebate rules, Sachs does give the Trump administration credit for “normalizing the ideas behind both of these rules,” even though the execution was less than successful. To read the entire column, click here.

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