On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former

In remarks delivered on November 29 at the American Conference Institute’s 35th International Conference on the Foreign Corrupt Practices Act, Deputy Attorney General Rod J. Rosenstein announced that the U.S. Department of Justice (DOJ) had revised its policy concerning individual accountability in corporate cases. That policy, previously set forth in a September 2015 memorandum issued by

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

The final 2019 Medicare Physician Fee Schedule released on November 1, 2018 by the Centers for Medicare & Medicaid Services (CMS) includes a section entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.” Effective January 1, 2019, physicians may be reimbursed for certain virtual interactions with patients using several new billing codes.

One new

On October 29, 2018, the Commissioner of the New Jersey Department of Banking and Insurance issued two bulletins confirming that recent federal changes affecting the Affordable Care Act (ACA) don’t supersede New Jersey state law.

Bulletin No. 18-12, captioned “Short-Term, Limited Duration Insurance,” confirms that short-term, limited-duration health insurance plans, which never comply with New

On Oct. 31, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update the payment system for home health agencies and improve access to remote patient monitoring technology. The rule will allow home health providers to build the costs of remote monitoring technology into their Medicare reimbursement beginning Jan. 1, 2020.

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that certain policy changes in the Medicare Physician Fee Schedule relating to the documentation, coding and payment structure of Evaluation and Management office/outpatient visits will now be delayed until 2021. The changes were originally set to go into effect on January 1,

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from

On October 23, 2018, the U.S. Department of Labor, Department of Health and Human Services, and Treasury Department issued a proposed regulation that would expand the usability of health reimbursement arrangements (HRAs). The regulation would allow company employees to use HRAs to cover the cost of individual health insurance coverage, subject to certain conditions. The

On October 3, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The SUPPORT Act is intended to combat the opioid and heroin crisis by reducing use and supply, encouraging recovery, supporting caregivers and families, and driving innovation and long-term solutions. It also includes the expansion