On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in Novartis Pharms. Corp. v. Espinosa, et al., 1:21-cv-01479-DLF (D.D.C.) and United Therapeutics Corp. v. Espinosa et al., 1:21-cv-01686-DLF (D.D.C.) to consider the question of whether manufacturers may restrict the circumstances under which they offer the 340B ceiling price through contract pharmacy arrangements. We provide highlights from both events below.
Mr. Tawes described a number of recent, ongoing, and upcoming U.S. Health and Human Services Department, Office of the Inspector General (“OIG”) reports. Among other things, the following items were noteworthy:
In addition, Mr. Tawes noted that part of the reason that we may not see more reports from OIG on the MDRP or 340B is that 80 percent of their funding is from Health Care Fraud and Abuse Control Program or “HCFAC” and must be used for Medicare and Medicaid. Only the remaining 20 percent can be used for other programs.
Following up on his recent report on “For-Profit Pharmacy Participation in the 340B Program,” Mr. Vandervelde presented his research on the implications of contract pharmacies for today’s 340B program. Highlights of his presentation include:
On October 12, 2021, U.S. District Court Judge Dabney Friedrich held a joint hearing on pending motions in the ongoing Novartis and United Therapeutics 340B contract pharmacy lawsuits, Novartis Pharms. Corp. v. Espinosa, et al. and United Therapeutics Corp. v. Espinosa et al. Novartis and United Therapeutics are each challenging’s HRSA’s May 17, 2021 letter in which the agency informed the manufacturers that their contract pharmacy policies are in violation of the 340B statute and threatened to impose civil monetary penalties if they fail to honor contract pharmacy arrangements. Below are a few of the highlights from the hearing:
An oral argument hearing in the AstraZeneca contract pharmacy case has been scheduled for Monday, October 18, at 3:00 p.m. Eastern Time. The public videoconference link for the hearing can be found under the “Additional Resources” sidebar to the right.”
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As always, it is important that you carefully review this information in light of considerations that may be relevant to your organization and specific drugs. In particular, if you believe there are items of note to raise to OIG in connection with its ongoing work reviewing ASP issues, we encourage you to work with you Legal Counsel to evaluate whether and how to best communicate such information.