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The New Option in Town: Applying for the Low Volume Appeals Settlement

In November 2017, the Department of Health and Human Services (HHS) announced new settlement options for providers and suppliers stuck in the backlog of the Medicare appeals process. One of the new options available is the...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

"Breaking Bad" News: Sharing PHI During Opioid Crisis

In response to President Trump's declaration of the opioid crisis as a public health emergency, the Office for Civil Rights (OCR) released guidance intended to educate health care providers on how they can respond to requests...more

OCR Examines Hybrid Entity Designation in Latest HIPAA Settlement

On November 22, 2016, the University of Massachusetts Amherst (UMass) agreed to pay $650,000 and enter into a corrective action plan to settle allegations that it violated the HIPAA Privacy and Security Rules in connection...more

Are You Ready? New Round of HIPAA Audits Are Underway

On March 21, 2016, the Office for Civil Rights (OCR) formally announced the start of its 2016 Phase 2 Health Insurance Portability and Accountably Act (HIPAA) Audit Program. Unlike Phase 1, in which OCR's 2012 pilot program...more

Big Payment Changes Revealed In New Medicare Part B Drug Payment Test

On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) unveiled a new Part B Drug Payment Model that, if implemented, would represent a radical change in Medicare reimbursement for outpatient drugs. The...more

CMS Relaxes Proposals for Returning Overpayments, but Significant Questions Remain

On Thursday, the Centers for Medicare and Medicaid Services (CMS) published a long awaited final rule that fleshes out the requirement for health care providers and suppliers that participate in Medicare Parts A and B to...more

U.S.-EU Safe Harbor Agreement Reached: Introducing the EU-U.S. Privacy Shield

United States and European Union Commission negotiators announced today that they have reached a political agreement on a new data transfer framework that will replace the Safe Harbor Program, which was invalidated in 2015 by...more

Uncertainty Abounds After EU High Court Invalidates EU-U.S. Safe Harbor Framework

On October 6, 2015, the Court of Justice of the European Union declared invalid the more than 15-year-old EU-U.S. Safe Harbor Framework. Thousands of U.S. businesses have complied with, and thus relied upon, the Safe Harbor...more

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

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