Tagged: OIG

Data Privacy and Security

HIPAA on the Horizon in the New Year: Important Lessons from an Active 2023 and Regulatory Initiatives to Watch for in 2024

2023 marked 20 years since the first compliance deadline under the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy rule. Despite the two decades of experience with HIPAA, compliance continues to remain a challenge for HIPAA-covered entities as well as for their business associates. 2023 brought a large number of important HIPAA-related developments and lessons-learned...

Uncategorized

Tracking Online User Activity: HIPAA and Other Legal Risks

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 technologies to identify their patients’ care needs and improve patient experience. As the use of tracking technologies burgeons, so do concerns from individuals about how...

Uncategorized

HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”).  Prior to this update, the SDP had not been updated since 2013.  While many of the revisions were procedural only, some of the revisions were...

OIG Guidance

OIG Advisory Opinion No. 21-02 Provides Helpful Insights into Risk Mitigation Factors Regarding Health System-, Physician-, and Management Company-Owned Ambulatory Surgery Centers

On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a health system, orthopedic surgeon and neurosurgeon employees of the health system, and a management company. This latest Advisory Opinion is notable...

OIG Guidance / Regulatory Sprint

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed...

Healthcare Fraud and Abuse / OIG Guidance / Regulatory Sprint

White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations

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 U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes...

Uncategorized

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

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 device companies organize and fund. These programs are typically company-sponsored events at which one or more physicians or other health care...

Regulatory Sprint

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...

Healthcare Fraud and Abuse

Is Your Compliance Program More than a Paper Program? DOJ Issues Revised Guidance for Evaluating Corporate Compliance Programs

On June 1, 2020, the Department of Justice (“DOJ”) issued an updated version of its “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), available here. The DOJ Guidance is an update to guidance first issued by the DOJ in February 2017 (which we described in our prior blog post), and was last updated by the...

OIG Guidance

OIG Initiatives to Ease Provider Burdens Related to COVID-19

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has taken numerous steps to minimize regulatory burdens for providers who need to make their primary focus delivering patient care during the COVID-19 national emergency. These steps, along with recent steps taken by other agencies to provide temporary regulatory flexibility, provide further...

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Health care is changing rapidly, and change will continue. If you or your business operates in the health care world, you need more than just legal counsel. You need to stay Well Ahead by identifying and addressing your company’s risks and opportunities. More about the Health Care Litigation and Government Investigations, Health Transactions and Regulations, Health Benefit Plans, and Intellectual Property Protection and Enforcement practice groups.

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avatar for Alissa SmithAlissa Smith

Alissa represents health systems, hospitals, pharmacies, long-term care providers, home he...

Managing Editor

avatar for Hannah McCallumHannah McCallum

Hannah brings specialized knowledge and real-life experience to help her clients make infor...

Contributors

avatar for Andrew BrantinghamAndrew Brantingham

Andrew's experience spans a wide range of industries, and has particular depth in...

avatar for Rebecca BrommelRebecca Brommel

Becki assists clients in the areas of litigation and administrative law wit...

avatar for Katie CownieKatie Cownie

Katie has worked on business and corporate issues for more than 20 years. Many of...

avatar for Lillie CoxLillie Cox

Lillie assists a wide array of healthcare industry clients with corporate transact...

avatar for Ross C. D'EmanueleRoss C. D'Emanuele

Ross works in the health care provider, payor, and drug and medical device segment...

avatar for Nathan EbnetNathan Ebnet

Nate represents clients in all stages of complex civil disputes, from pre-...

avatar for Elise FesterElise Fester

Elise counsels a wide variety of clients in the Health Care industry on regulatory...

avatar for Adam FreedAdam Freed

Adam provides strategic advice to health care providers through all stage...

avatar for Randall HansonRandall Hanson

Randall is an associate in Dorsey’s health transactions and regulations practice group.

avatar for Alan IversonAlan Iverson

Alan is a litigator in Dorsey’s trial group with a focus on clients in...

avatar for Michael JenkinsMichael Jenkins

Mike serves clients in highly regulated industries, including health care and gam...

avatar for Jamie McCartyJamie McCarty

Jamie counsels clients in the healthcare industry in connection with complex busi...

avatar for Laura C.S. NewberryLaura C.S. Newberry
avatar for Neal N. PetersonNeal N. Peterson

Neal regularly advises clients regarding compliance with laws specific to the he...

avatar for Mara SandersMara Sanders

Mara regularly advises clients on matters of state and federal regulatory complia...

avatar for Vanessa J. SzalapskiVanessa J. Szalapski

Vanessa's practice focuses on litigation in the healthcare industry, including gen...

avatar for Claire H. ToppClaire H. Topp

Claire works in three diverse sectors – health care, tax exempt organizations,...

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