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
On October 11, 2023 the Minnesota Supreme Court issued an opinion in Schneider v. Children’s Health Care holding that the Minnesota Health Records Act (“MHRA”) provision allowing health care providers to release health...more
Companies may face class action lawsuits as early as July 2023 based on Washington’s new privacy law. Governor Jay Inslee recently signed House Bill 1155, the WA My Health, My Data Act (“MHMDA” or “the Act”), giving companies...more
5/24/2023
/ Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
Class Action ,
Compliance Dates ,
Covered Entities ,
Data Collection ,
Data-Sharing ,
Enforcement ,
Gender Identity ,
Geolocation ,
Governor Inslee ,
GPS ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Legislation ,
PHI ,
Reproductive Healthcare Issues ,
State Privacy Laws
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
On February 1, 2023, the Federal Trade Commission (FTC) filed a complaint in the U.S. District Court for the Northern District of California alleging that digital health platform GoodRx violated the FTC Act by repeatedly...more
2/16/2023
/ Business Associates ,
Covered Entities ,
Data-Sharing ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Breach Notification Rule ,
Pharmacies ,
PHI ,
Unfair or Deceptive Trade Practices
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
With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under...more
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
As we described in a prior blog post, the Centers for Medicare & Medicaid Services (“CMS”) published multiple COVID-19 Blanket Waivers for Health Care Providers. CMS announced another round of Blanket Waivers on April 30 ...more
The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) is generally known for providing relief funds and other resources to help individuals, small businesses, state and local governments,...more
On Mach 27, 2020, President Trump signed the CARES Act, providing in part for $100 billion in relief funds to eligible health care providers and suppliers affected by COVID-19. The funding is intended to support...more
On Monday, April 6th the Centers for Medicare and Medicaid Services (“CMS”) adopted an interim final rule to change a wide range of Medicare payment policies during the COVID-19 public health emergency so that Medicare...more
On March 30, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a compilation of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (each, a “Blanket Waiver”). Section 1135 of the...more
With the aim of enabling providers to focus attention and resources on fighting the COVID1-19 pandemic, CMS announced over the weekend that it intends to alleviate some of Medicare participating providers’ and suppliers’...more
On March 27, 2020, the President signed into law the “Coronavirus Aid, Relief, and Economic Security Act’’ (“CARES Act”). The CARES Act is the third phase of the federal government’s response to the coronavirus following two...more
In light of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) issued recent non-binding guidance (“Guidance”) on the conduct of ongoing clinical trials of medical products. The FDA acknowledges that the public...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 Centers for Medicare and Medicaid Services (CMS) has issued a final rule to require every hospital licensed in the United State to make public a robust set of standard charges for every item or service that the hospital...more
Medicare reimbursement for remote patient monitoring has taken a number of steps forward throughout this year. New and proposed rules from the Centers for Medicare and Medicaid Services both expand the billing options...more