We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals” and therefore, that HHS exceeded its statutory authority by varying the 2018 and 2019 rates for 340B hospitals without first conducting such survey.
Department of Health and Human Services
Second Circuit Affirms HHS Rejection of Direct Copayment Assistance under Anti-kickback Statute
By Conor Duffy & Guest Contributor on
Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.
On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is…
Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The case, which was brought by the American Hospital Association, arises from reimbursement reductions imposed by the Department of Health and Human Services (HHS) in 2018 and 2019 on hospitals participating in the 340B program (which the Court noted are hospitals that “generally serve low-income or rural communities”). In those years, HHS sought to impose reductions in reimbursement due to favorable pricing available to 340B hospitals under that program. The hospitals challenged those reductions based on the process HHS followed when setting the reimbursement rates, claiming that HHS’s failure to conduct a survey of hospitals’ average acquisition costs for the drugs prevented HHS from varying reimbursement rates for this distinct group. Therefore, according to the hospitals, HHS was required to pay them based on the average sales price charged by manufacturers for the drugs.…
HHS Warns Hospitals to Fix Security Vulnerability in PACs
In a rare move, the Department of Health and Human Services (HHS) has issued a warning to hospitals and health systems to prioritize the patching of a two-year-old vulnerability in picture archive communication systems (PACs). PACs are used for the exchange and storage of health scans and images, such as MRIs, CT Scans, breast imaging,…
COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act
On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity to certain individuals and entities arising from the manufacturing, distribution, administration or use of medical countermeasures (e.g., therapeutics and vaccines) against COVID-19.
Continue Reading COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act
HHS Proposes Modifications to the HIPAA Privacy Rule to Enhance Care Coordination and Management and Remove Barriers to Accessing Information
By Conor Duffy & Jean Tomasco on
Posted in HIPAA, Privacy and Security
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which is one of several rules that protect the privacy and security of individuals’ medical records and other protected health information (PHI). According to HHS, the proposed changes are intended to support individuals’ engagement in their health care, remove barriers to coordinated care and case management, and reduce regulatory burdens on the health care industry, while continuing to protect the privacy and security of individuals’ PHI.
Continue Reading HHS Proposes Modifications to the HIPAA Privacy Rule to Enhance Care Coordination and Management and Remove Barriers to Accessing Information
COVID-19 Pandemic Brings Telehealth into U.S. Homes
By Conor Duffy & Peter Struzzi on
Posted in COVID-19, Telehealth
Excerpt of a contributed article published in Medical Economics on August 13, 2020.
The public health emergency (PHE) caused by the COVID-19 pandemic has resulted in systemic changes throughout the nation’s health care system. Almost overnight, health systems, providers and the government were forced to collaborate to ‘stand up’ field hospitals, testing sites, and quarantine…
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 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
Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency
By Melissa (Lisa) Thompson & Conor Duffy on
Posted in Academic Medical Centers, Accountable Care Organizations, COVID-19, Fraud and Abuse, Government Enforcement, Health Information Technology, Healthcare Technology, HIPAA, Hospitals and Health Systems, Legislation, Medical Devices, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Privacy and Security, Reimbursement, Telemedicine
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
HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency
By Conor Duffy, Lisa Boyle & Robinson+Cole's Health Law Group on
Posted in Academic Medical Centers, EMTALA, Fraud and Abuse, Government Enforcement, Health Information Technology, HIPAA, Home Health Agencies, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Privacy and Security, Reimbursement, Stark Law
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