The Centers for Medicare & Medicaid Services (“CMS”) final rule for Medicare payment for services provided in hospital outpatient departments (paid under the Outpatient Prospective Payment System or “OPPS”) and ambulatory...more
12/12/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Drug Pricing ,
Final Rules ,
GME ,
Hospitals ,
Medicare ,
Medicare Payment Reform ,
Outpatient Prospective Payment System (OPPS) ,
Reimbursements ,
Reporting Requirements ,
Site-Neutral Exception ,
Telehealth ,
Trump Administration
Since we published an update on the expiring telehealth flexibilities last week, the government has entered the third week of shutdown with no signs of an imminent resolution. As uncertainty around the treatment and future of...more
On October 1st, certain key telehealth flexibilities created during the COVID-19 public health emergency (“PHE”) expired as the government shutdown began. The Centers for Medicare & Medicaid Services (“CMS”) issued a number...more
On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down...more
The Centers for Medicare & Medicaid Services recently published the calendar year (“CY”) 2026 proposed rule for Medicare payment for services provided in hospital outpatient departments under the Outpatient Prospective...more
8/14/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Deadlines ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Price Transparency ,
Proposed Rules ,
Telehealth ,
Trump Administration
Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with...more
DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
1/31/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Cannabis Products ,
Clinical Trials ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
Hart-Scott-Rodino Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Marijuana ,
Marketing ,
Medical Devices ,
Medical Marijuana ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B ,
Technology Sector ,
Telehealth ,
Telemedicine
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
1/9/2025
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
National Security ,
Public Health
With only two weeks remaining in the year, Congress is considering a government funding deal (the “Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025” or the “Bill”) that includes a...more
12/19/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Extensions ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
New Legislation ,
Popular ,
Public Health Emergency ,
Technology ,
Telehealth ,
Telemedicine
Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs. Of course, DOJ did not conduct a major rewrite, but interestingly, the updated...more
10/30/2024
/ Acquisitions ,
Artificial Intelligence ,
Compliance ,
Corporate Governance ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Guidance Update ,
Mergers ,
Policies and Procedures ,
Risk Assessment ,
Technology Sector
Over two years into the post-Dobbs era, women’s health is taking center stage in the presidential election. In Dobbs v. Jackson, the Supreme Court overturned protections relating to abortion established in Roe v. Wade. Since...more
10/7/2024
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Health Care Providers ,
Healthcare ,
Legislative Agendas ,
Political Candidates ,
Pregnancy ,
Presidential Elections ,
Reproductive Healthcare Issues ,
SCOTUS ,
State Bans
On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more
On June 27, 2024, the U.S. Supreme Court dismissed Idaho v. United States on procedural grounds and sent the case back to the Ninth Circuit. By doing so, the Supreme Court reinstated the preliminary injunction issued by the...more
On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more
Almost 40 years after its passing, the Emergency Medical Treatment and Active Labor Act (EMTALA) remains not only a key consideration for hospitals with emergency departments, but also a significant federal enforcement...more
Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization...more
On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule,...more
4/16/2024
/ Agents ,
Beneficiaries ,
Biosimilars ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Chronic Care Managment (CCM) ,
Compensation ,
Competition ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part C ,
Medicare Part D ,
Mental Health ,
Policies and Procedures ,
Reporting Requirements ,
Supplemental Benefits ,
Third-Party
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed...more
On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department...more
11/8/2023
/ American Hospital Association ,
Class Action ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Third-Party ,
Tracking Systems ,
Web Tracking
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more
10/18/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Mental Health ,
Patient Access ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
On July 13, 2023, the Food and Drug Administration (“FDA”) approved the first daily contraceptive for use without a prescription. Opill® (norgestrel) tablet, .075 mg has been approved to prevent pregnancy in individuals of...more
On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical...more
5/17/2023
/ Abortion ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Health Care Providers ,
Hospitals ,
Investigations ,
Medicare ,
Pregnancy ,
State of Emergency
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
5/15/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations ,
Waivers