Regulatory Trends

Feds’ Year-End Guidance Will Affect Electronic Prescribing and EHRs

By Tony Schueth, CEO and Managing Partner The world of health IT was buzzing this week in the wake of a massive rule drop by the Office of the National …

POCP Responds to Proposed Regulation Requiring Adoption of Real-Time Pharmacy Benefit Check by Medicare Part D

By Tony Schueth, CEO and Managing Partner Medicare Part D could adopt the Real-Time Pharmacy Benefit Check (RTPBC) beginning as early as January 1, 2020. That is what’s proposed in …

Kicking Back the Anti-Kickback Rules for Patient Data Sharing?

By Michael Burger, Practice Lead, EHRs and EDI The government anti-kickback statute, aka the Stark legislation, prohibits physician ownership and involvement in certain kinds of healthcare activities. It’s long been …

State and Federal Regulations Continue to Target the Opioid Epidemic and Part D Prescribing

By Keith Fisher, R.Ph. and Michelle Soble, R.Ph. Co-Leads, POCP Regulatory Resource Center Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.¹ In …

New POCP Report Examines How States are Addressing Opioid Prescribing, A Root Cause of the Epidemic

By Tony Schueth A first-of-its kind report that details how states are fighting the opioid crisis at the prescription level has been developed by Point of Care Partners (POCP). Unlike …

Missouri Creates a Unique PDMP

By Connie Sinclair, Director, Regulatory Resource Center Until recently, Missouri was the only state without a Prescription Drug Monitoring Program (PDMP).  Growing evidence suggests that use of these state-run databases …

How Stakeholders are Affected by FDA’s New Naming Convention for Biologics and Biosimilars

By Pooja Babbrah, Senior Consultant Stakeholders across the industry are debating potential costs and burden associated with implementing the new, nonproprietary naming convention for biologics and biosimilars. Requirements for the …

5 Ways the AMA’s 21 Prior Authorization Principles Impact Electronic Health Records

By Michael Burger Recently a multi-stakeholder consortium led by the American Medical Association (AMA) published a white paper entitled “Prior Authorization and Utilization Management Reform Principles.” This paper identifies 21 …

Recent Regulations Continue Promotion of ePrescribing

By Michael Burger, Senior Consultant The federal government continues to keep its foot on the gas to further the adoption and effectiveness of electronic prescribing (ePrescribing) through the rulemaking process.  …

Biosimilar Legislative Trend Means Big Changes for EHRs

By Connie Sinclair, Director, Regulatory Resource Center Biosimilars are starting to enter the market in the United States and are generating interest because of their significant cost-savings potential and patient …