Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days per year must obtain a license, which includes completing an educational course determined by the Commissioner of Public Health (Commissioner), submitting a registration form to the Department, and paying a $750 licensure fee. Renewal applicants will be required to complete at least 5 hours of continuing education in the areas of ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing, and other areas that the Commissioner may designate by rule. Training courses may not be provided by the pharmaceutical representative’s employer. The ordinance takes effect on July 1, 2017.
Tag Archives: transparency
Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency Reporting
The Centers for Medicare & Medicaid Services (CMS) recently announced in the 2017 Physician Fee Schedule proposed rule that since publication and implementation of the Open Payments Final Rule and the 2015 Physician Fee Schedule, various stakeholders have provided feedback to CMS regarding aspects of the Open Payment program, including identification of certain areas that may benefit from revision. Thus, CMS is soliciting comments to inform future rulemaking, but made it clear that it was not intending to finalize any Open Payments requirements directly as a result of the 2017 Physician Fee Schedule.
To further discuss the topics listed in the 2017 Physician Fee Schedule, CMS held today a Special Open Door Forum for industry stakeholders “to inform future rulemaking and other enhancements” to the Open Payments program. CMS provided a presentation slide deck for the Open Door Forum, which outlined various topics in which it was soliciting stakeholder feedback, including:
Last week, Vermont adopted the first state law that requires drug companies registering the highest hike in prices to justify the rationale for the increase. Vermont policymakers are not alone pursuing laws that address rising drug prices. California and Ohio are eyeing pricing-related bills and ballot initiatives. This begs the question: If several states begin adopting a patchwork of drug pricing laws, what can or will happen at the federal level?
The Centers for Medicare & Medicaid Services (CMS) announced today that it had released an improved Open Payments website. The website has been enhanced with a homepage tool for searching by doctor name, a “snapshot” of Open Payment data, and additional sections to explore and download data.
Additionally, CMS updated the Open Payments dataset previously published on June 30, 2015. This updated Open Payments dataset reflects changes made to records, changes to delays in publication flags, changes to disputed records, and records that were deleted since original publication. These changes were submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) to CMS. This data should be carefully reviewed by all covered recipients.
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and transfers of value related to continuing medical education (CME). As we previously discussed, there has been confusion in the industry regarding CMS’ changes to reporting requirements for CME beginning in January 1, 2016, which were implemented as part of the 2015 Medicare Physician Fee Schedule. In sum, CMS reiterated that it expects applicable manufacturers to report payments and other transfers of value related to CME if the payment or transfer of value meets the definition of “indirect payment” and the manufacturer “knows or finds out the identity” of the physician speakers and/or attendees within the reporting year or by the end of the second quarter of the following reporting year. “Indirect payment” is defined as “a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.”
There remains some concern among industry regarding its obligation to identify physician speakers and attendees. Although CMS uses in several instances the “knows or finds out the identity of” language, one FAQ uses slightly different and potentially more problematic language – “knows or can determine the identity of the covered recipient.”
CMS also released last week another round of Open Payment FAQs primarily related to its June 30, 2015 release of data. The new FAQs are the following:
Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49 billion from applicable manufacturers to physicians and teaching hospitals. One key takeaway from the infographic is applicable manufacturers are spending significant resources to track and report de minimis payments and transfers of value to covered recipients. For example:
- 9 million food and beverage interactions were reported at an average of $23.80 per instance
- Gifts accounted for 0.45% of the reported spend
- 49% of physicians in the database received less than $100 total
OIG Releases Updated Mid-Year Work Plan: Open Payments, Clinical Laboratory Payments & Opioid Billing Trends Added to Agenda
The Health and Human Services Office of Inspector General (OIG) released last week an updated mid-year Work Plan for FY2015, which removes items that have been completed, postponed, or canceled and includes new items that have been started since October 2014. The FY2015 OIG Work Plan that we previously discussed is available here.
Notably, 21 items were added to the OIG’s mid-year Work Plan. Some key additions include the following areas:
- Review of Financial Interests Reported under the Open Payments Program. The OIG intends to determine (i) the number and nature of financial interests that were reported to the Centers for Medicare & Medicaid Services (CMS) under the Open Payments Program; (ii) the extent to which CMS oversees manufacturer and group purchasing organization (GPO) compliance with data reporting requirements; and (iii) whether the reported data is accurately and completely displayed in the publicly available database. According to the OIG, it is “important that the information be complete and accurate to serve the needs of consumers making educated decisions about their health care choices.” This update is timely given the anticipated publication of 2014 data by CMS on June 30, 2015 and recent release of its annual report to Congress.
- Annual Analysis of Medicare Clinical Laboratory Payments. As we discussed here, there have been a number of recent government enforcement announcements related to clinical laboratory payments that violated the federal Anti-Kickback Statute. The OIG intends to analyze Medicare payments for clinical diagnostic laboratory tests, including the top 25 clinical diagnostic laboratory tests by Medicare expenditures in 2014.
- Billing Trends for Part D Drugs and Commonly Abused Opioids. The OIG intends to describe trends in Part D billing from 2006 to 2014, including changes in billing for commonly used opioid drugs and billing trends associated with pharmacies in 2014. In the mid-year Work Plan, the OIG notes that it is “seeing a significant increase in Part D fraud and has a wide portfolio of work involving pharmaceutical matters, including prescription drug diversion.” This is notable because of government enforcement actions, such as the investigation and suit filed by the City of Chicago, which alleged that five pharmaceutical manufacturers marketed opioids in violation of Illinois’ consumer fraud laws and caused doctors and pharmacies to submit false claims to the city for payment (currently, only the suit against one pharmaceutical company is active).