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The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.
Background
The ADR final rule originates from a 1996 notice published by HRSA that established a process for manufacturers and covered entities to voluntarily resolve disputes involving drug diversion, duplicate discounts, ceiling price violations, and a set of minor other issues. In 2010, the Affordable Care Act directed the Secretary to promulgate ADR regulations. HRSA issued an advanced notice of proposed rulemaking on September 20, 2010, seeking comment on the original process established by the 1996 notice. Six
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As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only for health care providers, but for all manner of businesses, employers, property owners, and the national media. HIPAA – or more often than not “HIPPA” – was frequently touted in the news and on social media as the reason why COVID-related information could or could not be shared. As we head into 2021 with the pandemic raging on, the vaccination program underway, and a new administration taking over, here is a look at what we expect for “HIPPA” in 2021.
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Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration. One of the highest priorities for the Food and Drug Administration (FDA) during this “pandemic year 1” was authorizing the use of COVID-19 medical countermeasures. Another high priority was policing fraudulent COVID-19 drugs, preventative products, herbal cures, and even vaccines (not to mention fake test kits, personal protective equipment, and other things regulated as medical devices). As of December 18, 2020, FDA had sent more than 150 warning letters to peddlers of fraudulent COVID-19 products, many in conjunction with the Federal Trade Commission (FTC) – and we
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What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some w
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The Department of Health and Human Services (HHS) is pushing ahead in its Regulatory Sprint to Coordinated Care with a new proposed rule, announced by HHS’ Office for Civil Rights (OCR) on December 10, to modify the HIPAA Privacy Rule. This proposed rule follows HHS’ 2018 Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI), which sought to identify regulatory impediments to value-based care presented by HIPAA, and comes on the heels of HHS’ recent changes to the rules implementing the Anti-Kickback Statute and Stark Law.
With this proposed rule, HHS aims to “reduce burden on providers and support new ways for them to innovate and coordinate care on behalf of patients, while ensuring that [HHS] uphold[s] HIPAA’s promise of privacy and security,” according to HHS Deputy Secretary Eric Hargan. It would achieve these objectives through a variety of updates to the Privacy Rule, which