Articles and Blogs

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

The Gilbert Family Foundation, Henry Ford Health and Shirley Ryan AbilityLab announced plans for a $439M inpatient rehab hospital and research facility in Detroit. Plans for the project include a 125,000-sf inpatient tower with 72 beds. According to a recent Bloomberg article, private equity is no longer a reliable last resort as a buyer... READ MORE

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the... READ MORE

NATIONAL 5 things to know about the new negotiations over Medicare drug pricing AHA releases new guidance for patient data use AHA Opposes Proposed Payment Cuts for Home Health Providers AHA infographic shows behavioral health hospital service trends AHA asks FTC to scrap proposed changes to premerger rules American Heart Association releases new policy... READ MORE

A group of California tech billionaires spent $800M to acquire nearly 50,000 acres of land between Sacramento and San Francisco to develop what they are calling a “modern metropolis”. The project, if approved, would be one of the largest development projects in the works nationally. While detailed plans have not been released, the project... READ MORE

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for... READ MORE

On September 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) that calls for minimum staffing standards in long-term care facilities (“nursing homes”). If finalized, the changes in the Proposed Rule would be used to survey nursing homes for compliance and enforced as part of CMS’s existing survey,... READ MORE

NATIONAL AHA issues letter of support for ‘gold card’ legislation AHA presses CMS to do more on cost sharing, junk plans Amazon’s One Medical CEO to step down later this year Americans support Medicare drug price negotiations CMS threatens to cut hospices from Medicare if they can’t prove legitimacy Data breaches are down, but... READ MORE