On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the administrative dispute resolution process applicable to all covered entities and drug manufacturers participating in the 340B Drug Pricing Program.
Everyone working in the health care industry today knows how often overpayments can occur; nevertheless, it is clear under the Affordable Care Act that any provider who receives an identified overpayment is under a direct legal mandate to return it.
Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.
The Office of the US Trade Representative on Friday, August 12 submitted to Congress the president’s draft Statement of Administration Action. The submission is necessary for US ratification and implementation of the Trans-Pacific Partnership.
The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.
US Customs and Border Protection (CBP) has been directed by Congress to be much more aggressive in enforcing the customs laws. This has led to CBP starting a number of new initiatives and procedures to target and take action on what it deems to be “high risk” transactions.
The Federal Trade Commission recently asserted its data security authority in two recent back-to-back enforcement actions, only a day apart from each other.
The summer heat has not been confined to the weather. US Customs and Border Protection is warming up the import world with more audits and enforcement actions.
Today, the US Department of Health & Human Services’ Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois’ largest healthcare system) will pay a record $5.5 million settlement for violating HIPAA.
On June 24, 2016, the non-profit Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule with the U.S. Department of Health and Human Services (HHS).
The GDPR lays out requirements for organizations that process EU residents’ data and generally provides people increased control over their personal data.
Two China-based clothing manufacturers, Motives Far East and Motives China Limited, and their affiliated US importer, Motives, Incorporated, agreed to pay nearly $13.4 million for engaging in a double invoicing scheme designed to defraud the US out of millions of dollars in customs duties.
After months of negotiations, it’s official: the EU-US Privacy Shield has been formally approved on both sides of the Atlantic, by the EU Commission and the US Commerce Department, despite concerns surrounding the adequacy of its earlier version.
In the recent case of International Information Systems Security Certification Consortium v. Security University, LLC, the Second Circuit articulated its test for analyzing nominative fair use claims in trademark infringement cases.
Recent reports indicate that advertising fraud is not only increasing but is now being run by groups alongside otherwise legitimate advertising businesses.
On Monday, July 11, 2016, the Office for Civil Rights (OCR) released a fact sheet with guidance for covered entities and business associates on HIPAA and ransomware.
The House of Representatives has voted 306-117 to approve the bipartisan GMO disclosure bill to amend the Agricultural Marketing Act of 1946 and to establish a mandatory National Bioengineered Food Disclosure Standard.
Although the United States has had effective economic sanctions on North Korea for many years, the temporary softening of US sanctions in 2000 has given way to ever-increasing sanctions since 2008.
On July 6th, CMS released a proposed rule (expected to appear in the Federal Register on July 15th) that, if it takes effect, could be devastating to hospital off-campus outpatient department reimbursement – an effect not intended by Congress, and certainly unwelcome to the healthcare industry.