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On October 21, 2024, the U.S. Department of Health and Human Services, Labor Department, and the Treasury Department (collectively “the Departments”) jointly released a proposed rule that would require insurers to expand coverage of and eliminate cost sharing on certain preventative services, including over-the-counter (“OTC”) contraceptive items and certain Food and Drug Administration (“FDA”) approved prescription birth control medications. The rule would require private health plans to provide new disclosures to beneficiaries regarding coverage of these services with no cost-sharing obligations.

According to the fact sheet issued by the White House, the rule if finalized would expand free birth control coverage for 52 million American women of reproductive age who are covered by private health insurance and would reduce barriers to coverage of contraceptive services, including OTC contraceptives.

However, there is some complexity to the finalization of this rule. The incoming Trump administration could follow the recommendations of Project 2025 and rescind this rule in whole or in part. Additionally, if the rule is finalized, it currently falls within the Congressional Review Act look-back period and that could result in a Republican-controlled Congress disapproving the rule in its entirety next year.Continue Reading Proposed Rule Could Enhance Contraceptive Coverage If It Survives New Administration

On Nov. 8, 2023, the Senate Finance Committee voted 26-0 to approve the Better Mental Health, Lower Cost Drugs, and Extenders Act. Among its other provisions, the bill, for which final legislative text has not yet been released, would, for the first time, mandate minimum prices that Medicare Part D plans, and the pharmacy…

On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally prosecuted for prescribing controlled substances (specifically, opioids) in violation of the Section 841(a)(1) of the Controlled Substances Act (“CSA”).  The consolidated cases—Ruan v. United States and Kahn v. United States—present questions regarding the requisite state of mind for a jury to convict a prescriber under the CSA and the availability and nature of a “good faith” defense to criminal liability under the statute.  By agreeing to hear these cases, the Court positions itself to resolve, or at minimum weigh in on, the current circuit splits regarding these issues.

Under the CSA, as interpreted by the Supreme Court in United States v. Moore, 423 U.S. 122 (1975), practitioners who are registered to legally prescribe controlled substances can nonetheless be found to have violated the CSA if they prescribe in a manner that “fall[s] outside the usual course of professional practice.”  However, petitioners argue that the state of mind necessary to convict varies by circuit.  Judicial willingness to issue a specific jury instruction on the availability of a “good faith” defense similarly varies.Continue Reading SCOTUS to examine “good faith” defense in criminal opioid prescription cases