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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

FDA Waives Premarket Notification Requirements for Ventilator Manufacturers, Solicits Manufacturers for Ventilator Support Devices...

On March 22, 2020, the U.S. Food and Drug Administration (FDA) published guidance that relieves manufacturers of FDA-cleared ventilator products of the requirement to submit a premarket notification (510(k)) prior to making...more

10 Key Points From CMS’ Guidance to Dialysis Facilities Regarding COVID-19

On March 10, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Dialysis Facilities. This guidance addresses practices...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

CMS Responds to COVID-19 National Emergency Declaration

On March 13, 2020, the Trump administration announced a series of waivers and regulatory flexibilities designed to help healthcare providers and states in responding to and containing the spread of the 2019 novel coronavirus...more

CMS Proposes Revising Physician Payments Sunshine Act Reporting Requirements

On July 29, 2019, the Centers for Medicare and Medicaid Services (CMS) released the Medicare CY 2020 Physician Fee Schedule proposed rule (the Proposed Rule), including proposed changes to regulations implementing the...more

AdvaMed Revises Code of Ethics on Interactions with Health Care Professionals

On Jan. 9, 2019, the Advanced Medical Technology Association (AdvaMed) approved an updated version of its Code of Ethics on Interactions with U.S. Health Care Professionals. The updated code will be effective Jan. 1, 2020. ...more

CMS Implements Survey Process of Home Dialysis Services in Nursing Homes

Effective as of September 16, 2018, the Centers for Medicare and Medicaid Services (“CMS”) implemented a survey process for the provision of home dialysis services in long-term-care facilities (“LTC Facilities” or “Nursing...more

HIPAA Breach Reporting Deadline: February 29

February 29, 2016, is the deadline for providing notification to the Secretary of the Department of Health and Human Services regarding breaches of unsecured protected health information that were discovered in the 2015...more

Highlights From The 2016 OIG Work Plan

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more

CMS Adopts ESRD PPS and QIP Final Rule for Dialysis Services

On November 6, 2015, the Centers for Medicare and Medicaid Services (CMS) published the final rule regarding the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services furnished to...more

OCR Enforcement of HIPAA Affects Entities of all Sizes Small Pharmacy Enters into Latest Settlement

U.S. Department of Health and Human Services (HHS) announced late last week that Cornell Prescription Pharmacy (Cornell) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996...more

HIPAA Breach Reporting Deadline: March 1

March 1, 2015 is the deadline for providing notification to the Secretary of the Department of Health and Human Services regarding breaches of unsecured protected health information that were discovered in the 2014 calendar...more

CMS Issues Final Rule on Reimbursement for Chronic Care Management Services

On November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) issued the Medicare Physician Fee Schedule final rule, including a new code and guidance for billing for chronic care management services (CCM),...more

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