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Sep 4, 2024 | 
jdsupra.com | Shoshana Golden |Douglas Grimm |Gayland Hethcoat II
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies. Three years later, the “340B Saga” continues. Following the filing of new cases and developments in others, we are back with another update.
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Aug 22, 2024 | 
jdsupra.com | Gayland Hethcoat II |Moyosore Koya
On June 20, a federal district court in Texas ruled that the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) exceeded its authority under the Health Insurance Portability and Accountability Act (HIPAA) by issuing guidance that expanded the law’s definition of “individually identifiable health information” (IIHI) to include an individual’s IP address captured on a public webpage about health conditions or health care providers.
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Jun 19, 2024 | 
jdsupra.com | Gayland Hethcoat II
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the cyberattack in February, health care providers have been uncertain about their notification responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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May 29, 2024 | 
jdsupra.com | Gayland Hethcoat II |Moyosore Koya |Jill Steinberg
On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule designed to support the privacy of reproductive health care.
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May 15, 2024 | 
jdsupra.com | Douglas Grimm |Gayland Hethcoat II |Stephanie Trunk
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR) process under a Final Rule published on April 19, by the US Department of Health and Human Services’ Health Resources and Services Administration (HRSA).
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Mar 15, 2024 | 
jdsupra.com | David Greenberg |Douglas Grimm |Gayland Hethcoat II
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its technology systems after reporting it was the victim of a cyberattack. Weeks later, health care providers continue to grapple with the operational, financial, and legal implications arising from the incident. What Happened?
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Dec 4, 2023 | 
jdsupra.com | Gayland Hethcoat II |Moyosore Koya
With the recent passage of Assembly Bill (AB) 254 and AB 1697, California’s Confidentiality of Medical Information Act (CMIA) will extend privacy protections to reproductive and sexual health information on mobile applications and internet websites. This expansion of CMIA’s scope notably impacts digital health companies and other entities that offer online reproductive or sexual health services in California.
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Aug 15, 2023 | 
jdsupra.com | Douglas Grimm |Gayland Hethcoat II
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online provider marketplace. As in an earlier 2019 opinion, OIG concluded that the company’s business model would not result in unlawful kickbacks and patient inducements.
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Jun 6, 2023 | 
jdsupra.com | Douglas Grimm |Gayland Hethcoat II
Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of Health and Human Services (HHS) in early 2020 that the COVID-19 pandemic was a public health emergency (PHE). Although the PHE officially ended on May 11, 2023, several telehealth flexibilities remain available to health care providers and their patients.
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Apr 4, 2023 | 
jdsupra.com | Gayland Hethcoat II
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach notification requirements under the Health Insurance Portability and Accountability Act (HIPAA).
