Garfunkel Wild’s HIPAA, Privacy, and Risk Management Practice Group assists health care providers, insurance plans and their vendors (e.g., Independent Practice Associations, billing and software companies, Health Information Exchanges) in preparing for, and addressing, complex regulatory and operational issues. Our objective is to assist our clients in implementing programs to avoid government interventions, and to support our clients when surveys, investigations, and settlement demands by federal and state regulatory and accreditation agencies occur.
HIPAA and Privacy
Information has become the foundation of providing quality health care, and therefore, a significant focus of health care providers and their vendors. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) establishes – at a national level – the minimum requirements for protecting and ensuring the availability of patient information. Other federal and state laws and regulations, however, add additional requirements for certain types of information and technology. Garfunkel Wild has mastered this ever-changing and complex regulatory landscape and has assisted clients in:
Assessing and implementing HIPAA privacy and security compliance plans, including model policies/forms and training in a manner that also includes consideration of state requirements and accreditation standards
Responding to breaches of confidentiality of unsecured patient information including patient, federal and state notifications
Preparing responses to investigations by the Federal Department of Health and Human Services, Office of Civil Rights (OCR), and similar state agencies;
Defending entities in governmental investigations/actions and private causes of action for alleged federal and state privacy violations
Identifying appropriate strategies to allow for sharing of patient information for operational purposes (e.g., quality assurance, value based programs, research)
Negotiating business associate agreements
Implementing procedures to avoid allegations of Information Blocking
Responding to federal and state subpoenas and other discovery requests involving protected health and other patient-identifying information
Our HIPAA and Privacy team can assist in addressing all of the challenges of protecting patient information, while allowing for appropriate use and sharing of such information to improve and develop our clients’ health care services.
Risk Management
Health care providers are faced with a plethora of regulatory and litigation concerns; more so than most industries. Garfunkel Wild has a deep understanding of the risks that our clients face, and assists our clients and their clinical leadership to navigate these regulatory complexities. Our Risk Management team has extensive experience in:
Preparing plans of correction to address findings identified by the Center for Medicare and Medicaid Services (CMS), state departments of health and the Joint Commission
Drafting Medical Staff Bylaws
Preparing admission forms and informed consents for operative procedures, off label use of medications and other unique treatment scenarios
Providing guidance and counsel to address professional misconduct and abuse reporting situations, as well as internal disciplinary decisions regarding licensed health care professionals
Implementing quality assurance and performance improvement programs, including consideration of applicable privileges and immunities
Drafting policies and procedures to address regulatory and accreditation requirements
Assisting providers across the healthcare spectrum through multifaceted licensure processes (e.g., laboratory permits and CLIA certification, radiology permits, pharmacy licenses, pharmaceutical wholesaler and manufacturing registrations)
Providing comprehensive review of regulatory compliance for merger and acquisition transactions
Our Risk Management team is standing by to assist our clients in taking the steps necessary to protect against unintended mishaps, and to address incidents if they occur.
Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
Join the health care professionals of Garfunkel Wild and Withum as they dive into the technical, legal, and financial steps you will need to take to come into compliance with the new cybersecurity regulations for New York hospitals.
On March 9, 2024, CMS announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to providers experiencing potentially significant cash-flow problems as a result of the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum .
The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records.
The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.
Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023.
As we have noted in a previous Garfunkel Wild alert, the Department of Health and Human Services (“DHHS”) Office of Civil Rights (‘OCR”) published guidance regarding the use of tracking technologies (i.e., technologies that collect and analyze information about how users interact with websites and mobile applications).
This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.
In the last few months of 2023, there has been a flurry of legal activity pertaining to the use, disclosure, and protection of health information. Here is a summary of the latest legal initiatives impacting New York providers.
In this article published in the New York City Pharmacists Society Newsletter, Stacey Gulick highlights some of most significant, and perhaps unexpected, issues that must be addressed by pharmacists in their ongoing HIPAA compliance efforts.
On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders
Join Garfunkel Wild’s Jeffry Adest, Emily Schwerd, and Jenny Brown as they discuss the OSV process, highlight the areas HRSA reviewers consider, and impart meaningful tips on how FQHCs can be in compliance.
Scammers have perpetuated a telephone fraud scheme attempting to extort money and personal identifiable information from healthcare providers by impersonating Drug Enforcement Administration (“DEA”) agents across the country.
Garfunkel Wild's Health Care Information and Technology Practice Group's Podcast Series "Health Information Technology Podcast- Termination and Transition Periods".
The Department of Health and Human Services, Office of Civil Rights (“OCR”) has published a Bulletin which officially states that incorporating certain tracking technologies into websites and mobile applications may cause HIPAA violations that could result in breach notification obligations as well as penalties. This includes platforms and services provided by companies like Meta (formerly Facebook) and Google.
Earlier today, the United States Health and Human Services Office for Civil Rights (“OCR”) issued an alert concerning fraudulent postcards sent to health care organizations claiming to be official communications from OCR.
Robert Del Giorno will present at the Long Island Health Information Management Association John W. Ruth Annual Membership Conference on April 21, 2021.
Garfunkel Wild’s Terence Russo and Garfunkel Health Advisors Alicia Shickle will present at the Medical Society of New Jersey (MSNJ) Webinar – Review of 2021 E/M Guideline Changes and Information Blocking New Rules on April 8, 2021.
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
The Equal Employment Opportunity Commission has issued new guidance for workplaces, dated April 17, 2020, as they start the process of preparing for the impending re-opening of their entities in the face of the Covid-19 pandemic.
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Jeffry Adest will present at the 2nd Annual Center for Health Education, Medicine, & Dentistry (CHEMED) Conference on Medicine & Ethics on February 14, 2020.
As most of you are aware, all 2019 HIPAA security breaches affecting less than 500 individuals must be reported by covered entities (e.g., providers and health plans) to the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”) prior to February 28, 2020.
he New York SHIELD Act has gone into effect today (October 23, 2019) and entities that maintain electronic information regarding New York residents will need to ensure compliance.
On October 23, 2019, the Stop Hacks and Improve Electric Data Security (“SHIELD”) Act goes into effect and significantly modifies the existing New York State breach notification requirements, including the addition of new requirements for covered entities (e.g., all health care providers and health plans) to report HIPAA breaches to the New York State Attorney General, as well as the Federal Department of Health and Human Services, Office of Civil Rights (“OCR”).
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.
