Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. Maryland has become the first state to do so – on May 26, 2017, Governor Larry Hogan of Maryland informed the Maryland Speaker of the House that he would permit H.B. 631, also known as the “Prohibition Against Price Gouging for Essential Off-Patent or Generic Drugs”(437th Gen. Assemb., Reg. Sess. (Md.
The Supreme Court issued a stunning ERISA decision on Monday, overturning the law in the three federal circuits as to what constitutes a “church plan” that is exempt from ERISA’s requirements. In Advocate Health Care Network v. Stapleton, 581 U. S.
Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices (“AMPs”) of their products are rising faster than inflation when compared to a base line period.
In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:
In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.
What’s New?In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth. But bipartisan groups of Senators have introduced two bills seeking to expand telehealth services covered by Medicare.
On May 10, 2017, the US Department of Health & Human Services (HHS) announced a settlement with Texas-based Memorial Hermann Health System (MHHS) for $2.4 million due to MHHS’s unauthorized disclosure of patient protected health information (PHI). HHS also announced that HHS and MHHS entered into a Resolution Agreement, and MHHS agreed to a corrective action plan.