Will COVID-19 Cause a Delay to CCPA Enforcement?
On March 11, days before most U.S. businesses across the country had to close their doors to fight the spread of COVID-19, the California Attorney General (AG) provided notice of a second set of modifications to the proposed California Consumer Privacy Act (CCPA) regulations. The period window for submitting comments was between March 11, 2020 [...]
Comparing Transparency Reporting Requirements Around the World
Transparency reporting requirements for life sciences companies are increasing all over the world. The United States was the first country to enact comprehensive transparency reporting requirements for life sciences companies as part of the Patient Protection and Affordability Care Act in 2010. Known as Open Payments, the law requires annual reporting by applicable manufacturers to [...]
Seven Steps to Managing an Effective HCP Engagement Process
An effective technology solution should follow the seven steps outlined below to ensure a systematic methodology is in place to apply controls throughout the healthcare professional (HCP) engagement process in order to reduce the risk of improper payments. Needs Assessment and/or Event Justification: A needs assessment process documents a defined, legitimate business, medical or scientific [...]
HCP Partnerships Continued Complexity Means Technology Solutions Are a Requirement
For years, industry payments to physicians have been scrutinized by enforcement agencies, politicians and watchdog groups. In fact, the government has been playing an active role in monitoring these transfers of values for years through an increasing number of physician payment reporting laws that started with the state of Minnesota in 1993. Shortly thereafter, California, [...]
Are You Prepared for Open Payments/Sunshine Expansion?
On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) published the final 2020 Physician Fee Schedule which, along with the October 2018 passing of Section 6111 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), introduces several changes to the Open Payments Program.[1] [...]
Technology Solutions Are Key to Managing HCP Engagements
The industry has effectively used technology for decades in every facet of the business. From enterprise resource management to CRM platforms, technology has been an integral part of the industry’s expansion and growth; however, many compliance departments lag in adopting systems to manage their compliance programs. For example, many organizations continue to use manual processes, [...]
Proposed Changes to the Standards for Integrity and Independence in Accredited Continuing Education
The Accreditation Council for Continuing Medical Education (ACCME) invited comments about the proposed revisions to the rules that protect the independence and integrity of accredited continuing education for healthcare professionals. The ACCME will accept comments until February 21, 2020, at 5 PM Central. The proposed ACCME Standards for Integrity and Independence in Accredited Continuing Education [...]
What Compliance Professionals Can Expect in 2020
Chief compliance officers have struggled at the bottom of the food chain for both budget and technology for years. While revenue generating departments have received the lion’s share of attention as it relates to technology, they have purchased solutions in silos, based on the needs of their individual departments. The result has been a data [...]
Open Payments Reporting and Beyond
March 31, 2020 is quickly approaching which means many pharmaceutical and medical device companies are feeling the pressure of the looming CMS Open Payments reporting deadline. Whether your organization is filing for the first time, struggling with an outdated reporting system or using too many valuable internal resources to get the job done – you [...]
Bridging the HCP Engagement Gap Between Compliance and Commercial Webinar
Life sciences companies often struggle to balance the needs and wants of internal stakeholders when it comes to managing paid HCP/O engagements: compliance wants to mitigate risk, commercial wants to grow the business and manage relationships and IT wants an integrated solution to ensure all stakeholders are happy in achieving their objectives. MediSpend’s HCP engagement [...]
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