Department of Health and Human Services

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On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced that it would distribute up to $25 billion of CARES Act Provider Relief Funds to safety net hospitals and state Medicaid and Children’s Health Insurance Program (CHIP) providers.
Continue Reading HHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General Distribution

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector General (OIG) announced it will allow healthcare providers to reduce or waive cost-sharing for telehealth visits.
Continue Reading Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.
Continue Reading HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac Cardio. Sac Cardio has agreed to pay $506,000 to resolve allegations of duplicative billing associated with one of these compensation arrangements. Separately, the settlement includes another $15,117,516 from Sutter to resolve self-disclosed conduct principally concerning the PSR Law.
Continue Reading DOJ Announces Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group

On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response…

On August 13, 2019, the D.C. Circuit Court of Appeals (the D.C. Circuit) issued an opinion in Children’s Hospital Association of Texas v. Azar (No. 18-5135), allowing the Department of Health and Human Services (HHS) to include payments from third parties, including Medicare and private insurers, in calculations of Disproportionate Share Hospital (DSH) payment caps. The D.C. Circuit had previously ruled against HHS’ implementation of its 2017 rule, which included third-party payments in the calculation of the hospital-specific caps on allowable DSH payments. 
Continue Reading D.C. Circuit Court of Appeals Allows HHS Rule that Includes Payments Received from Third Parties in DSH Payment Cap Calculation

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.
Continue Reading Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

As Hurricane Florence was making landfall, Department of Health and Human Services Secretary Alex Azar issued HIPAA guidance that outlined when hospitals in declared state of emergency areas can qualify for a waiver of certain provisions of the HIPAA Privacy Rule, including fines and penalties.
Continue Reading HHS Issues Limited Waiver Following Hurricane Florence

This week, the Department of Health and Human Services (HHS) issued its “Report on Improving Cybersecurity in the Health Care Industry,” which is the culmination of a year-long effort on behalf of the Cybersecurity Task Force, made up of industry professionals from the public and private sectors to identify and develop recommendations “on the growing challenge of cyber-attacks targeting health care.”
Continue Reading HHS Releases Health Care Industry Cybersecurity Task Force Report

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).

Local Transportation Safe Harbor

This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met.  An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health care items (for example, durable medical equipment suppliers or pharmaceutical manufacturers).
Continue Reading New Anti-Kickback Safe Harbors and Exceptions to CMP Law