Articles and Blogs

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to... READ MORE

Investment firm Black Salmon is partnering with Allen Morris Company on a $1B mixed-use development in the Miami Health District. The 7-acre project is expected to include 500,000 sf of medical office, 1,000 apartments and a 150-room hotel. Fitch Ratings expects the recently proposed federal nursing home staffing standards to increase costs for SNFs,... READ MORE

NATIONAL Amazon moves into healthcare generative AI with $4B investment Biden administration to ban medical debt from credit scores CMS encourages physicians to apply for new Making Care Primary model CMS settles $9.2M in Stark law self disclosures: 3 things to know CMS’ staffing proposal will cost nursing homes $6.8B for 102K nurse hires,... READ MORE

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services found that most skilled nursing facilities (“nursing homes”) in Georgia that it surveyed are not correctly complying with life safety requirements or emergency preparedness requirements. OIG recently issued a report on its audits of life safety requirements or emergency... READ MORE

NATIONAL AHA Comments on House Proposed “Lower Costs, More Transparency Act” AHA shares workforce bill concerns with Senate committee AHA to agencies: Don’t finalize draft merger guidelines Amazon mulls tying healthcare to Prime: Insider Burnout growing among PAs; 8% plan to leave Costs for common healthcare procedures higher in hospital outpatient departments Cyberattacks keep... READ MORE

In 2023, nursing homes have seen increased citations by surveyors for noncompliance tied to their pre-dispute, binding agreements for binding arbitration with their residents. When used appropriately, these agreements can streamline conflict resolution processes, but operators must tread carefully to ensure compliance with the regulations. Regulations In 2019, the Centers for Medicare & Medicaid... READ MORE

Kayne Anderson Real Estate acquired a $1.3B medical office building (“MOB”) loan portfolio from Synovus Bank. The loan portfolio includes 106 floating-rate mortgages secured by 308 MOBs across 33 states. CBRE released its Q2 Healthcare Real Estate Investor Update. MOB transaction volume for Q2 remained consistent with the previous quarter with $1.8B in transactions... READ MORE

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. The Draft Guidance is aimed at researchers conducting clinical trials using psychedelic drugs. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to... READ MORE

This Week (September 15, 2023): Drug Enforcement Administration (“DEA”) officials have been holding pre-regulatory listening sessions with stakeholders to discuss a new special provider registration requirement for practitioners who are prescribing controlled substances through telehealth without first establishing a provider-patient relationship. Why it Matters: The special registration is mandated by the Ryan Haight Act,... READ MORE

NATIONAL 988 suicide hotline adds support for American Sign Language 3 Takeaways from Physician Compensation Trends Adventist Health completes merger with Montebello’s ailing Beverly Hospital AHA-supported bill to protect health care workers introduced in Senate AHA weighs in on CMS’ proposed ASC payment system AHA submits comments on CY 2024 OPPS proposed rule, including... READ MORE