The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more
1/17/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Prescription Drugs ,
Public Health ,
Public Health Emergency ,
Regulatory Requirements ,
Ryan Haight Act ,
Substance Abuse ,
Telemedicine
After much uncertainty, Congress has extended many Medicare telehealth flexibilities through March 31, 2025, in its end-of-year appropriations bill. However, several important flexibilities, such as first-dollar coverage of...more
On December 10, 2024, Senator Markey (D-Mass) and Senator Mike Braun (R-Ind.) sent a letter to various private equity (PE) firms who have invested in opioid treatment programs (OTPs). The letter requested information...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more
11/21/2024
/ Abbreviated New Drug Application (ANDA) ,
Cloud Computing ,
Corrective Actions ,
Data Collection ,
Data Management ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Information Technology ,
Policies and Procedures ,
Record Retention
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more
7/30/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Treatment ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Opioid ,
Physician Fee Schedule ,
Popular ,
Proposed Rules ,
SAMHSA ,
Substance Abuse ,
Telemedicine
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs...more
2/12/2024
/ Certifications ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Licensing Rules ,
Medical Evaluation Reports ,
Opioid ,
Public Health Emergency ,
SAMHSA ,
Substance Abuse ,
Telemedicine
On January 18, 2024, the Centers for Medicare & Medicaid Services (CMS) announced a new innovation model designed to improve quality of care and behavioral and physical health outcomes for Medicaid and Medicare patients with...more
On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued its 2024 Physician Fee Schedule final rule (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes...more
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance)....more
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more
Special thanks to summer associate Sheridan Organ for her contributions to this article. On May 4, 2023, the Florida Senate passed SB 254 by a sweeping vote of 83 to 23. This law, which imposes restrictions on...more
On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based...more
On May 10, 2023, the Missouri legislature passed a bill restricting access to gender affirming care for individuals under the age of 18. The bill is now headed to Governor Parson’s desk for signature...more
On May 4, 2023, SB 254 passed the Florida Senate by a safe majority vote of 83 to 28 and is now on Governor DeSantis’s desk for approval. Once signed (expected shortly) , this law will take immediate effect and disrupt the...more
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials.
DHTs include a wide array of...more
The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more
Starting January 1, 2023, Medicare will expand and increase coverage of certain services and providers to advance access to prevention and treatment services for substance use disorders (SUD) and mental health services. These...more