Health Care Counsel Blog
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Headlines that Matter for Companies and Executives in Regulated Industries
We are pleased to announce that Arent Fox professionals will be presenting during the 2019 Chief of Staff Boot Camp hosted by The Institute for Medical Leadership.
The Office of Inspector General for the Department of Health and Human Services recently published its Semiannual Report to Congress, for the period April 1 to September 30, 2018.
On November 30, HRSA announced that it is “notifying all stakeholders that the secure pricing component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be open for the submission of manufacturer pricing data in the first quarter of 2019.”
At an FCPA conference on November 29, Deputy Attorney General Rod Rosenstein announced revisions to DOJ’s policy regarding pursuit of individuals involved in corporate wrongdoing. The current policy, memorialized in the 2015 “Yates Memo,” instructed that, “[t]o be eligible for any cooperation credit
The Centers for Medicare & Medicaid Services (CMS) released an advance notice of proposed rulemaking (the ANPR) seeking comments on its proposal to dramatically change the way the agency pays for separately payable Part B drugs and biologicals.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
This August, Ohio became the first state in the nation to pass a law incentivizing organizations to develop a strong data protection and cybersecurity program.
On October 26, 2018, the Health Resources and Services Administration (HRSA) updated its online National Practitioner Data Bank (NPDB) Guidebook for the first time since April 2015. The Guidebook provides information to eligible entities and professionals regarding reporting to the NPDB, querying th
Earlier this week, in Potts v. Center for Excellence in Higher Education, the Tenth Circuit held “that the False Claims Act’s anti-retaliation provision unambiguously excludes relief for retaliatory acts occurring after the employee has left employment.” 2018 WL 5796963, — F.3d — (10th Cir. Nov. 6,
Below is a roundup of headlines that matter and key takeaways from the industries and issues we’re following closely. We’ll be back later today with more in-depth analysis.
Headlines that Matter for Companies and Executives in Regulated Industries
Colorado’s new consumer data protection law, the Protections for Consumer Data Privacy Act, took effect September 1 and companies now have another set of requirements to comply with for their data privacy compliance.
The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or biological covered by Medicare or Medicaid to include a disclosure of the product’s “current list price” for a “typical” thirty day supply.
Headlines that Matter for Companies and Executives in Regulated Industries
President Trump signed into law a bill that expands the Open Payments reporting requirements.
On Friday, October 19, 2018, the Maryland Attorney General (AG) filed a petition for writ of certiorari to the United States Supreme Court (SCOTUS) regarding Maryland’s drug price gouging law (the Law)– the first state law enacted to prohibit alleged drug price gouging by manufacturers.
Headlines that Matter for Companies and Executives in Regulated Industries
President Trump is expected to sign into law a bill which will – among other things – expand the scope of the Open Payments reporting requirements mandated by Section 6002 of the Patient Protection and Affordable Care Act (often referred to as the Sunshine Act).
Headlines that Matter for Companies and Executives in Regulated Industries
On September 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed an amended complaint to revive its lawsuit seeking to block implementation and enforcement of California’s drug price transparency law.
On October 1, 2018, the New York State Department of Labor announced its final regulations to prevent workplace harassment.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries