In a letter to Rep. Jim McDermott, Health and Human Services (HHS) Secretary Kathleen Sebelius answered a question frequently asked by healthcare providers and pharmaceutical and device manufacturers in the roll-up to implementation of the Affordable Care Act: “Are the qualified health plans (QHPs) established through the Act ‘federal health care programs’ under section 1128B of the Social Security Act?”
Just in time for the September 23, 2013, deadline for compliance with the HIPAA Omnibus Rule, the U.S. Department of Health and Human Services (“HHS”) issued a set of model notices of privacy practices for health care providers and group health plans, available at http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html.
On September 19, the Department of Health and Human Services issued new guidance on the “refill reminder” requirements under HIPAA that will have important implications for pharmaceutical manufacturer-funded communications to patients.
The Department of Health & Human Services (HHS) released on September 19, 2013 guidance on financially remunerated prescription refill reminders.
On September 5, 2013, Adheris, Inc. (“Adheris”), a Massachusetts company that provides, among other services, prescription refill reminders, filed a lawsuit in the U.S. District Court for the District of Columbia against Kathleen Sebelius, Secretary of Health & Human Services (“Secretary”), and the Department of Health & Human Services (“HHS”), challenging the constitutionality of the HITECH Final Rule’s restrictions on remunerated prescription refill reminders.
In a court filing on September 11, 2013, attorneys for the U.S. Department of Health and Human Services (HHS) announced that HHS intends to issue further guidance on certain new marketing restrictions under HIPAA, finalized last January as part of the final HITECH omnibus rule, and to delay enforcement of those new marketing restrictions until November 7, 2013, instead of commencing enforcement on September 23, 2013, as previously announced.
Self-Reporting Violations to Office of the Inspector General in Healthcare Cases: Recent Developments
Recent developments in the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) and Congress have changed the calculus of healthcare providers by making self-disclosure easier and more beneficial, while simultaneously providing OIG with greater ability to punish companies and individuals who fail to report but then after a government investigation are found to have violated healthcare laws.
Monday Morning Regulatory Review: FOIA Discovery, Social Cost of Carbon, Computer Energy, Food Safety
Regulatory complexity and related rulemakings are the focus of the review this week, with multiple rulemaking actions in a number of agencies.
In anticipation of developing its rule to implement the Affordable Care Act’s (ACA) health plan nondiscrimination provisions, the U.S. Department of Health and Human Services (HHS) has issued a request for information (RFI) from interested parties.