Midweek update

Today, the Office of Management and Budget posted the Fall 2019 regulatory update on its website.  A friend of the FEHBlog took the time to identify ongoing regulatory actions that relate to the FEHBP from OPM and HHS.

Updates:

"Federal Employees Health Benefits Program: Data Reporting," now at OIRA. Expected publication, November 2019.

“Federal Employees Health Benefits Acquisition Matrix Regulations Self Plus One and Contract Matrix Update.” The proposed rule was published on April 2, 2019. The Spring Agenda listed October 2019 as the expected publication date for the final rule. The new expected publication date is January 2020.

“Federal Employees Health Benefits Program Regulations: Revised Guaranteed Issue Conversion Requirements.”             The proposed rule was published on February 21, 2018. The new expected date of the final rule is February 2020. The spring agenda estimated a publication date of July 2019. 

“HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement.” A proposed rule is expected to be published in December 2019. The Spring agenda called for a July 2019 publication. A request for information was published in November 2018. 

“21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program.” A proposed rule was published on March 3, 2019. The Spring agenda called for the publication of November 2019 on a final rule; the new agenda retains that date.

Fierce Healthcare reports on legislative pressure on HHS concerning the last pending regulatory action.

Last week, the FEHBlog noted that the Food and Drug Administration had approved a Pfizer manufacturer bio similar version of Abbie Vie's blockbuster specialty drug Humira. Fierce Pharma reminds us that due to patent issues, Pfizer cannot laugh its bio similar until 2023. Similarly, the Wall Street Journal reports that patent laws are interfering with the release of small molecule / regular generic drugs. These stories point out that Congress urgently needs to reform the patent laws that impair prescription drug competition.

Finally, Healthcare Dive reminds us that the Project Nightingale issues are still percolating.

There's no dispute both actors [Ascension Health and Google] are compliant with the 1996 patient protection and privacy law [HIPAA]. But the emergence of details on Project Nightingale last week sparked renewed conversation about data sharing, especially with tech behemoths that come with a checkered past with consumer trust and data use. 

HHS' Office of Civil Rights opened an investigation into the partnership and multiple legislators including Sens. Mark Warner, D-Va., Bill Cassidy, R-La., and Richard Blumenthal, D-Conn., along with Democrat presidential candidate Amy Klobuchar, issued statements decrying the actions of both companies.

It should come as no surprise that people are sensitive about their medical records.