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
Epstein Becker & Green, P.C. Blogs
Latest from Epstein Becker & Green, P.C.
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
Attention On-Boarding Managers: A New Form I-9 and New Options for Verifying Employment Eligibility (but There’s a Catch …)
When the pandemic abruptly shifted many employment relationships from offices and other physical workplaces to remote environments, many governmental and regulatory authorities responded by modifying existing protocols to accommodate new realities. Among those were temporary adaptations to long-standing federal requirements for inspecting identification and verifying employment eligibility, whereby employers were permitted to forego standard document
California Court of Appeal Holds That Unexpected Work Expenses May Be Reimbursable
The California Court of Appeal for the First Appellate District recently issued its opinion regarding business-related expenses in Thai v. International Business Machines Corporation. The Court found that expenses incurred by employees in direct consequence of performing their jobs may be reimbursable regardless of whether such expenses are directly caused by the employer.
Paul
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
SEC Finalizes Cybersecurity Rule: What It Means
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
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
The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?
On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a nationwide health care fraud enforcement action targeting a variety of alleged health care fraud schemes. As has been the case