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OIG Plans New Guidance for Medicare Advantage and Nursing Homes

In its General Compliance Program Guidance (GCPG) issued in November 2023, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced its intent to publish industry segment-specific...more

Key Takeaways From McGuireWoods’ Webinar on HIPAA and Cybersecurity for Medical Device Companies

On Jan. 17, 2024, McGuireWoods partners Kimberly Kannensohn and Sam Bernstein conducted a webinar regarding how the Health Insurance Portability and Accountability Act (HIPAA) applies to medical device companies and certain...more

OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers

On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more

HHS Proposes Information Blocking Disincentives to Complement Existing Penalties

On Nov. 1, 2023, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) issued a proposed rule, the “21st Century Cures Act:...more

CMS Issues End-Stage Renal Disease Prospective Payment System Final Rule for 2024

On Oct. 27, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year (CY) 2024. The ESRD prospective payment system...more

HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees

On Oct. 13, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07 approving a multispecialty physician practice’s proposal to pay bonuses to each of its...more

HIPAA Privacy Rule Changes Coming in 2023: Five Steps to Prepare

In 2023, the Department of Health and Human Services (HHS) is expected to finalize proposed modifications to its regulations under the Health Insurance Portability and Accountability Act of 1996, as modified by the Health...more

HIPAA Enforcement Discretion Ends When Public Health Emergency Expires on May 11

The Department of Health and Human Services’ Office for Civil Rights (OCR) announced the expiration of its enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of 1996...more

Distributor of Ophthalmic Surgical Products Found Guilty of Paying Kickbacks and Violating the False Claims Act: May Be Liable For...

On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons...more

Physicians and Their Employers Must Notify California Patients About Open Payments Database

Under a new California law, effective Jan. 1, 2023, physicians and their employers must begin notifying their California patients during a patient’s initial visit of the Open Payments database, and documenting such notice in...more

CMMI Releases Request for Applications for Kidney Care Choices Model, Performance Year 2023

On Feb. 28, 2022, the Center for Medicare and Medicaid Innovation (CMMI) published a Request for Applications for the second cohort of the Kidney Care Choices (KCC) Model, including the Centers for Medicare & Medicaid...more

Arizona Passes Broad Telehealth Law With Audio-Only Coverage

In response to the COVID-19 public health emergency (PHE), many states expanded access to healthcare via telehealth through regulatory waivers. Experts have speculated how governments will regulate and reimburse telehealth...more

Cyber-Insurance Considerations for Healthcare Providers Related to Ransomware Attacks

On May 7, 2021, the operator of a major pipeline system that transports fuel across the East Coast fell victim to a ransomware attack that resulted in a six-day shutdown. Over the following week, East Coast stockpiles of...more

CMS Delays Start of First Performance Year Period for Kidney Care Choices Model

On March 5, 2020, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced that it is delaying the inception of the Kidney Care Choices (KCC) Model’s first performance year until Jan. 1, 2022. The CMS’...more

Department of Health and Human Services Announces Proposed Changes to the HIPAA Privacy Rule

On January 21, 2021, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for...more

OIG Issues Special Fraud Alert That Challenges Industry Norms Regarding Speakers Programs

On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical...more

OCR Warns Providers and Media: Patient Privacy Remains Protected Despite Pandemic

Since the outbreak of COVID-19, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has issued various notifications of enforcement discretion related to compliance with the Health Insurance...more

HHS Expands HIPAA Enforcement Discretion During COVID-19

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued further notifications of enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of...more

COVID-19: Consolidated Medicare Telehealth Expansion Update

On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC). This alert is part of a series of alerts discussing the IFC provisions and comprehensive actions...more

CMS Grants ESRD Facilities More Flexibility, Waives Certain Conditions For Coverage During COVID-19

On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced it was providing additional flexibility to end-stage renal disease (ESRD) facilities under the Medicare conditions for coverage at 42 CFR §§...more

CMS Announces Enforcement Discretion for Late Open Payments Reporting Due to COVID-19

On March 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Open Payments Program COVID-19 announcement and released an updated comprehensive list of frequently asked questions about the Open Payments...more

HHS Limited Waiver and Guidance on HIPAA and the Privacy Rule During COVID-19 Pandemic

Since the outbreak of COVID-19, the Department of Health and Human Services Office for Civil Rights (OCR) has issued various guidance documents on compliance with the Health Insurance Portability and Accountability Act of...more

Revised Families First Coronavirus Response Act Becomes Law — Five Things Healthcare Providers Need to Know

On March 16, 2020, the U.S. House of Representatives unanimously passed corrections to the Families First Coronavirus Response Act (H.R. 6201), which was originally passed by the House on March 14, 2020. On March 19, the...more

HHS Acts to Support Telehealth Services in Response to COVID-19: Six Key Takeaways

The unprecedented public health emergency created by the coronavirus disease (COVID-19) has sparked action by the U.S. government to ensure greater access to healthcare via telehealth services, especially for high-risk...more

House Passes Families First Coronavirus Response Act – Five Things Healthcare Providers Need to Know

On March 14, 2020, the U.S. House of Representatives voted 363 to 40 (with one representative voting present) to pass H.R. 6201 – Families First Coronavirus Response Act. The bipartisan legislation, negotiated between House...more

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