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
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more
This year’s Going Digital Health’s Behavioral Health Tech Conference (GDBH) was well-attended and rife with insightful panel presentations and discussions featuring key players from across the behavioral health and substance...more
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more
Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more
Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults. ...more
This November, Coloradans have opportunity to make history and vote for Colorado to become the second state in the country to regulate therapeutic access to “natural medicines.”...more
On October 6, 2022, President Joe Biden issued a statement on marijuana policy reform, accompanied by a proclamation and decision to pardon individuals prosecuted for the simple possession of marijuana in violation of the...more
On June 7, 2022, Governor Jared Polis signed into law the Colorado False Claims Act (CFCA) at Colo. Rev. Stat. Ann. § 24-31-101 et seq. The CFCA is largely based on the Federal False Claims Act (FCA), but is not an exact...more
Over the last two years, behavioral health (BH) has been one of the biggest growth areas in the health care ecosystem, fueled by the Public Health Emergency (PHE) but in many ways an ignored, overlooked, understaffed, and...more
4/1/2022
/ CMMI ,
Consolidated Appropriations Act (CAA) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Health Care Providers ,
Investors ,
Medicaid ,
Mental Health ,
Mental Health Parity Rule ,
MHPAEA ,
NQTLs ,
Out of Network Provider ,
Public Health Emergency ,
Reimbursements ,
Substance Abuse ,
Surprise Medical Bills
On Wednesday, February 23, 2022, U.S. District Court Judge Jeremy Kernodle of the Eastern District of Texas granted the Texas Medical Association’s and Adam Corley’s (the Plaintiffs) motion for summary judgment on their...more
Many hospital, health systems and other health care providers have seen benefits in sponsoring sports teams, stadiums and athletic tournaments. Considerations include general branding in the community, recruitment of staff or...more
2/10/2022
/ Advertising ,
Compliance ,
Corporate Branding ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Marketing ,
Medicare ,
Reporting Requirements ,
Sponsors ,
Sponsorship Agreements
When a company decides to self-disclose misconduct (or conduct that may be construed as such) to the government, that decision triggers a stream of additional questions. In the weighty deliberations about whether and what to...more
12/2/2021
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Legal Representatives ,
Liability ,
OIG ,
Self-Disclosure Requirements ,
Suppliers
The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more
7/16/2021
/ Audits ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FQHC ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
OIG ,
Public Health Emergency ,
Relief Measures ,
Rural Health Care Providers ,
Telehealth
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
7/9/2021
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Medical Devices ,
Medicare ,
OIG ,
Open Payments ,
Prescription Drugs ,
Sunshine Act
On April 20, 2021, Denver Mayor, Michael Hancock, signed the Marijuana Omnibus Bill and Marijuana Hospitality Bill into law, which make significant changes to Denver’s current cannabis laws. These changes directly address...more
Recent reports indicate that the federal government has been seizing medical equipment and supplies from hospitals across the country in its response to COVID-19. The issue for hospitals and other health care providers,...more
On Wednesday April 22, 2020, the U. S. Department of Human Health and Services (HHS) unveiled its plan to disperse an additional $70 billion in COVID-19 funding authorized by the Coronavirus Aid Relief and Economic Security...more
On April 13, 2020, the Denver City Council approved a new local license to regulate and implement medical cannabis research and development facilities, marking the beginning of the city’s efforts to update its cannabis rules....more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers and temporary rule changes designed to assist the health care system in coping with patient surges due to the novel...more
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more
3/25/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medicare ,
Relief Measures ,
Social Security Act ,
State of Emergency ,
Waivers
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more