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Covered Entities Reporting Requirements Department of Health and Human Services (HHS)

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

Williams Mullen

Physician Group Monitoring of “Open Payments”

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Is your physician group monitoring the Open Payments database? Each June, the Centers for Medicare and Medicaid Services (CMS) releases data showcasing the payments made by reporting entities to physician groups and other...more

Mintz - Health Care Viewpoints

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

BCLP

Causes of Healthcare Data Breaches

BCLP on

Pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), covered entities (e.g. healthcare providers and health plans) must notify the Department of Health and Human Services (“HHS”) of breaches...more

Baker Donelson

Deadline Approaching to Report Certain HIPAA Breaches to Federal Officials

Baker Donelson on

The HIPAA Breach Notification Rule requires covered entities to notify the Secretary of the Department of Health and Human Services (HHS) if a breach of unsecured protected health information (PHI) is discovered. As most...more

Cooley LLP

Alert: Five Ways to Reduce Your HIPAA Liability

Cooley LLP on

As of early December 2014, 1,170 security breaches under the Health Insurance Portability and Accountability Act (HIPAA) involving 31 million records had been reported to the U.S. Department of Health and Human Services (HHS)...more

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