Tag: HHS

Final Rule Released on ACA’s Individual Shared Responsibility Payment

On August 27, 2013, the Internal Revenue Service (“IRS”) and the U.S. Department of Treasury (the “Treasury Department”) released a final rule, Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage, (the “Final Rule”), which was published in the Federal Register today, to implement the individual shared responsibility provision provided for under […]

Do Exchanges Protect Data Privacy? State Officials Worry

During the last several weeks, officials in multiple states including Alabama, Florida, Georgia, Kansas, Louisiana, Michigan, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, Texas, and West Virginia have expressed concerns regarding data privacy risks presented by programs that assist consumers with enrollment in health insurance via the Health Insurance Exchanges […]

HHS Awards $67 Million in Navigator Grants under ACA

The United States Department of Health and Human Services (“HHS”) announced today that it awarded $67 million in grants to 105 navigator grant applicants. The navigator program was created under the Affordable Care Act (“ACA”) in an effort to provide unbiased information about health insurance options. Specifically, navigators will serve as an in-person resource for […]

HHS Requests Information Regarding the Affordable Care Act’s Nondiscrimination Requirements

On August 1, 2013, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) regarding the nondiscrimination provisions set forth in Section 1557 of the Affordable Care Act (“ACA”). This Section prohibits discrimination on the basis of race, […]

CMS Releases New Information About State Medicaid Drug Utilization Review Practices

On July 30, 2013, the Centers for Medicare & Medicaid Services (“CMS”) posted state annual Medicaid DUR reports for fiscal year 2012.  States are required to complete annual Medicaid drug utilization review (“DUR”) surveys outlining prescribing habits, and describing cost savings generated from state Medicaid DUR programs and their Medicaid program’s […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]