As the federal government continues to take action in response to events impacting the healthcare landscape, stakeholders must ensure that they are staying up-to-date with health information privacy and security developments...more
4/29/2024
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Patient Privacy Rights ,
PHI ,
Proposed Legislation ,
Reproductive Healthcare Issues
The use of tracking technologies on websites and mobile applications (e.g., cookies) has become largely ubiquitous in our technology-driven world. Health care providers and organizations, for example, may use tracking...more
3/15/2023
/ Business Associates ,
Class Action ,
Consent ,
Covered Entities ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Mobile Apps ,
OCR ,
PHI ,
Privacy Concerns ,
Third-Party ,
Third-Party Risk ,
Third-Party Service Provider ,
Tracking Systems
The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more
10/20/2022
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement Actions ,
Manufacturers ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Settlement ,
TRICARE
On July 1, 2021, the Department of Health and Human Services (HHS), along with other federal agencies, released an interim final rule implementing certain provisions of the No Surprises Act. The No Surprises Act aims to...more
In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect. These changes, which are part of the...more
The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical...more
The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements. The...more
9/11/2020
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Interim Final Rules (IFR) ,
Medicare ,
MIPS ,
Public Health Emergency ,
Reporting Requirements ,
Virus Testing
The CARES Act allocated $100 billion in relief funds to hospitals and other healthcare providers, to be distributed by the Department of Health and Human Services (“HHS”) through the Public Health and Social Services...more
The COVID-19 pandemic has dramatically increased the number of patients and providers seeking to implement and use telehealth visits and other digital health solutions – and rapidly, at that. The challenge of implementing...more
3/23/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Healthcare Facilities ,
Licensing Rules ,
Medicaid ,
Medicare ,
State of Emergency ,
Telehealth ,
Telemedicine
On March 17, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) each issued policy statements which expand access to telehealth...more
3/19/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Joint Policy Statements ,
Medicaid ,
Medicare ,
OIG ,
State of Emergency ,
Telehealth ,
Telemedicine
The first publicly disclosed prosecution under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month, a little over a year after EKRA became law. As we described in a previous blog post, EKRA criminalizes...more
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more
2/6/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months. Most recently, a...more
The Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma recently identified federal physician self-referral law (or “Stark Law”) reform as a top policy priority and reported that an inter-agency group is...more