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HHS OCR Issues 15th Records Access Settlement

HHS has issued its 15th HIPAA settlement involving a patient's right to access their medical records. Will enforcement of HIPAA's records access provision be a ....

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Advertising company WPP is leading $115 million HHS vaccine campaign

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WPP ad agencies are leading the Health and Human Services vaccine education campaign.
HHS says the next stage will be a $115 million-plus effort to encourage people to get the vaccine.
The campaign is focusing on minority communities, where vaccination rates are lower.
Advertising giant WPP has been leading a $250 million US Department of Health and Human Services coronavirus messaging campaign.
The biggest part of the campaign, a $115 million-plus effort to promote the vaccines, is set to launch imminently. An HHS spokeswoman said it would go live as soon as the supply begins to meet the demand. ....

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FDA, NTIA, and Domain Registries Remove Websites Illegally Selling Opioids

Tuesday, February 9, 2021
The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale. Working together as part of a pilot program jointly created by the Department of Health and Human Services (HHS) and the Department of Commerce (Commerce), FDA and NTIA aim to reduce the availability of unapproved and misbranded opioids illicitly offered for virtual sale. Based on several joint warning letters and the subsequent shuttering of numerous websites illegally selling opioids, it would appear the partnership is a success. Both agencies and the domain registries have committed to continuing this working relationship beyond the pilot program. Time will tell if the continued joint effort reduces the unlawful sale of opioids online and in turn, minimizes the risks associated with the opioid crisis. ....

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Fundamental Stark Law Terminology Changes

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HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology
Monday, February 8, 2021
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others. ....

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HHS and OMB Confirmation Watch

Friday, February 5, 2021
The confirmations of Cabinet secretaries and federal agency directors by the U.S. Senate are critical and early milestones in any new President’s administration. Permanent department leadership allows the executive branch to more aggressively pursue the President’s policy agenda and vision, to establish routine processes that facilitate the work of the federal government, and to signal continuity to stakeholder communities. The Senate’s delay in reaching a power sharing agreement has acutely impacted a number of committees charged with processing and advancing nominees to lead key federal departments and agencies. These nominees include Xavier Becerra for Secretary of the Department of Health and Human Services and Neera Tanden for Director of the Office of Management and Budget. ....

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