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On June 27, 2022, the United States Supreme Court, by a vote of 9-0, overturned the lower circuit courts’ rulings affirming the convictions of two physicians of the unlawful distribution of controlled substances. In Ruan v. United States (Case No. 20-1410), consolidated with Kahn v. United States (Case No. 21-5261), the Supreme Court was asked to determine whether a physician may be convicted of unlawful distribution of controlled substances under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, the physician “reasonably believed” or “subjectively intended” that his or her prescriptions fall within that course of professional practice. The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “except as authorized.” A prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The “vague and highly general regulatory language” left open the question of what conduct would fall under the statute’s exception and thus be considered legal.
Continue Reading Supreme Court Reaffirms Mens Rea Requirement in Controlled Substance Health Care Fraud Cases and Government Burden to Prove Subjective Bad Faith

Congratulations

jCyte, Inc., a biotech company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the further expansion of the company’s executive management team with the appointment of John Sholar as general counsel. The full piece can be found here: https://bit.ly/3uj3qzX

A heartfelt congratulations to John from the Husch Blackwell Healthcare,…

Colorful of oral medications on dark background.

Since mid-2020, many pharmaceutical manufacturers have introduced policies that scope their offering of 340B pricing, including limiting contract pharmacy arrangements and requiring covered entities to submit claims data. These policies have generated a good deal of attention generally, and a significant number of covered entities have made attendant complaints to the Health Resources and Services Administration (HRSA).
Continue Reading 340B Update: HRSA Notifies Six Manufacturers that They are in Violation of the 340B Statute

Medications

Missouri’s Senate advanced Senate Bill 63 this week in a move to become the last state in the Nation to create a Prescription Drug Monitoring Program (“PDMP”). The bill would establish a Joint Oversight Task Force for Prescription Drug Monitoring, if adopted by the House of Representatives and signed by Governor Parson.
Continue Reading Missouri Last in the Nation to Roll Out Prescription Drug Monitoring Program

Virtual Series

Please join Husch Blackwell as we go virtual with our Health Law Conference. The series will include a range of important topics relevant to the healthcare industry and will be moderated by Curt Chase, leader of the firm’s Healthcare, Life Sciences and Education team; Hal Katz, American Bar Association, Health Law Section, Chair; and Tom Shorter, American Health Law Association, President-Elect Designate. The webinar programs will be offered every Thursday through November 19.
Continue Reading Health Law & Innovation Virtual Series – Pharmacy Trends 2021: What to Watch Out for After The Year That Was

Virtual Series

Please join Husch Blackwell as we go virtual with our Health Law Conference. The series will include a range of important topics relevant to the healthcare industry. The webinar programs will be offered every Thursday from October 1 through November 19.

Our first session will include a panel discussion on a potential COVID-19 vaccine. The

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Medication

Many colleges and universities offer on-campus healthcare clinic services to their students. These student health clinics are typically staffed by a physician or advanced practice provider such as a nurse practitioner. In addition to providing professional services, these providers may on occasion prescribe medications to students. Some of our clients have asked whether it is also permissible for the providers to actually dispense these medications on-site, even though the clinic is not licensed as a pharmacy.
Continue Reading Dispensing Medications at Student Health Clinics

After the U.S. Department of Health and Human Services (“HHS”) automatically distributed $30 billion to providers as Tranche #1 Relief Fund payments based on 2019 Medicare fee-for-service payment data, HHS subsequently released a new formula that was based on 2018 “program service revenue” and intended to calculate providers’ payments under Relief Fund Tranches #1 and #2 cumulatively.  For providers whose Tranche #1 payments alone exceeded their expected payment under the new “program service revenue” formula, there have been ongoing questions about whether such providers were “overpaid” and needed to reject and return their Tranche #1 payments.
Continue Reading CARES Act Provider Relief Fund: Connecting HHS’s Dots on Whether Your Tranche #1 Payment Is An Overpayment

Background

 On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.”  In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and  Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.
Continue Reading HHS Clarification on PREP Act Impact on State Licensing Laws: What it Means for Pharmacists’ COVID-19 Testing Capabilities

On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing “high throughput technologies.” The reimbursement under Medicare Part B for these laboratory tests will be raised from about $51 per test to $100 per test. This increase will begin with tests performed on or after March 18, 2020 and end when the national emergency is over.
Continue Reading CMS Doubles Payment for Diagnostic Lab COVID-19 Testing