On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few days before the September 1, 2023, statutory deadline imposed by the Inflation Reduction Act (IRA). The negotiated pricing will
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Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating the Strict Liability Stark Law Since the Expiration of COVID-19 Public Health Emergency
When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal Physician Self-Referral Law (the “Stark Law”), which has draconian penalties, such as clawback of Medicare payments plus additional stiff monetary penalties and possible
DEA to Host Listening Sessions on Remote Prescribing
On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect additional input regarding the practice of telemedicine and specifically the remote prescribing of controlled substances without conducting an in-person evaluation
Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls
Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look
SEC Adopts Final Cybersecurity Reporting Rule
On July 26, 2023, the Securities and Exchange Commission (“SEC”) adopted its long-anticipated cybersecurity reporting rule (the “Final Rule”). The Final Rule applies to public companies subject to the reporting requirements of the Securities Exchange Act of 1934 and, in some cases, to foreign private issuers. As quoted in the SEC’s press release, SEC Commissioner
As COVID-19 Public Emergency Ends, So Do Vaccination Mandates
The federal government’s announcement that the COVID-19 public health emergency (“PHE”) declaration would end on May 11, 2023 marked the end of various federal mandates and benefits. The Centers for Disease Control’s authorizations to collect certain types of public health data expired, as did the requirement that insurance providers waive costs or provide free COVID-19
HRSA Initiates Audits and Requires Return of Provider Relief Funds
Throughout the course of the pandemic, the Health Resources and Services Administration (HRSA) distributed $178 billion in Provider Relief Funds (PRF) to hospitals and health care providers. The Public Health Emergency has ended, and HRSA is now turning an eye to how the money was spent, and whether it was spent properly.
PRF funds were
Unpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study
Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias?[1] How can that be, you might ask, for an algorithm that is simply grounded in biology and medical data? I’ll tell you, but
Hospitals May Risk Penalties with Use of “Gig” Nurses
As health care entities around the country face staffing shortages, hospitals have started to turn to apps to fill nursing shifts. New apps allow hospitals to engage nurses as independent contractors to fill open shifts, allowing nurses to bid on shifts and select hours that match their schedule. Apps allow nurses to work as independent
HHS OIG’s 13 New FAQs Shed Light on Post-Public Health Emergency Enforcement
On March 22, 2023, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) updated its Frequently Asked Questions (“FAQs”), drafting 13 FAQs aimed at easing the transition from COVID-era flexibilities to the end of the Public Health Emergency (“PHE”) on May 11, 2023. These FAQs arrive on the tail of OIG’s