Life Science Compliance Update

June 29, 2017

Chicago Releases Pharmaceutical Representative Disclosure Log Draft


The City of Chicago recently released a draft of the disclosure log pharmaceutical representatives will be expected to use to keep track of the interactions they have with Chicago physicians. The form requires pharmaceutical representatives to log the following information with respect to any interactions they have with physicians within city limits: HCP first name; HCP middle initial/name; HCP last name; HCP name suffix (i.e., Jr.); HCP primary business address; HCP license type (i.e., MD, DO, etc.); HCP state license number; HCP NPI (if applicable); date of interaction; location of interaction; duration of interaction; pharmaceuticals promoted; whether drug samples were provided, and if so, the quantity of samples given and the value of such samples; whether pharmaceutical-related materials were given, if so, the value of the materials given; and whether any other items of value or compensation were given, if so, what type and the combined value of other items.

The log includes instructions, which state,

Use one line per interaction. An interaction is any instance in which you communicate with an HCP as part of your work as a pharmaceutical representative, whether in person, over the phone, via video conference, by email, or via another communications method, as well as any time you leave materials or samples for that HCP, even if you do not communicate personally. However, you do not need to report a telecommunication or written communication if it was done simply to set up a meeting or other communication with an HCP and no marketing or promotion took place. It is not necessary to include time spent in a waiting room before meeting an HCP when reporting the duration of the interaction. If the options in any of the dropdown menus do not provide a perfect description of the contact, select the closest option. However, if the "HCP license type" dropdown menu does not include the license type of the HCP with whom you interacted, you do not need to disclose the interaction at all. If you interact with multiple HCPs at one time, for example through a dinner or entertainment event with several doctors, include a line for each HCP. If you cannot precisely break down the number of items or amount of compensation that went to each HCP because you provided them as a set to multiple HCPs, please report the average amount per HCP by dividing the number of items and the compensation value by the total number of HCPs. For instance, if you give a box of 50 samples to two HCPs jointly, mark down 25 apiece. For group meals or other forms of compensation that you provide to HCPs and non-HCPs jointly — like a lunch for a medical office that includes four HCPs and one receptionist — figure out the per-person cost and report that for each HCP. For instance, if you were to provide that office (four HCPs, one receptionist) with a $100 lunch, you would report $20 in food and beverages for each HCP.

The instructions are quite interesting and actually create more questions than they answer. While the next box explains that only interactions that take place while both parties are within the Chicago city limits should be reported, does that mean licensed representatives in Chicago have to disclose emails to physicians if both parties are within city limits when the email chain is started? What if the emails continue, after one party exits city limits?

The proposed disclosure form is draconian and adds unnecessary requirements for Chicago pharmaceutical representatives and the physicians they interact with.

May 23, 2016

CMS 2014 Medicare Part D Data Release and One CMS Officials Interpretation

Medicare data release
For the third year now The Centers for Medicare and Medicaid Services (CMS) released its updated Physician and Other Supplier Utilization and Payment public use data, which includes summarized information on Part B services and procedures provided to Medicare beneficiaries. CMS' eventual goal is to shift Medicare payments from volume to value, tying 30 percent of traditional Medicare payments to alternative payment models and tying 85 percent of all traditional Medicare payments to quality or value by the end of 2016.

Interestingly, many who had covered the first two data releases did not cover the most recent, third, data release in such detail (if at all). Some believe the lack of coverage is due to the fact that data releases from CMS have become frequent and routine, not to mention groups like ProPublica utilizing the data for consumers to use regularly, reducing public reliance on the actual Medicare data.

Even CMS didn't heavily publicize the release, only publishing a press release, announcing that the 2014 updated dataset contains information for just under 1 million providers (986,000), up from 950,000 providers in 2013. Niall Brennan, chief data officer at CMS, believes that "the release of timely, privacy-protected data is especially important as the Medicare increasingly pays providers based on the quality, rather than the quantity, of care they give patients."

Charles Ornstein of Propublica jointly publishing on National Public Radio (NPR) spoke with Niall Brennan around the same time as the data release. Brennan stated during the interview that the data releases by CMS have been gradual: they "started with relatively small and modest data releases – things like releasing data at the regional level on differences in Medicare spending among states and counties." From there, CMS moved to releasing information on "discharges at hospitals; how physicians practice medicine in the Medicare program; how they prescribe drugs in the Medicare program; how they prescribe durable medical equipment such as wheelchairs."

CMS continued on their path to openness and transparency, releasing Sunshine Act Open Payments data and giving consumers information to choose their health plan through the Affordable Care Act marketplace and Medicare Advantage.

When asked if he thought the data sets would continue to be released each year, Brennan responded, "I do. We're creating a good track record of consistency around releases. Unless something drastically changes in terms of agency priorities, I think people should expect to see these data releases on a regular basis for some time to come."

He was also asked why the delay in releasing the data – for example, the most recent release was a release of 2014 data. He stated that one of the reasons is that "it takes quite a lot of internal CMS time and resources to crunch through the data and make it ready for publication." He stated that CMS tries to make the data as accurate as possible so that people are not led to wrong inferences or conclusions.

He also mentioned the lag time in the bills submitted by providers to Medicare. He claimed that it can take up to nine months for the very final bills to be adjudicated and finally settled.

Ornstein asked one of the questions on everyone's lips: how should people use the data? Brennan stated that he hopes "that consumers will use the data to understand more about their doctors" and that he seemed to endorse the fact that "there are a lot of data innovators and data entrepreneurs and researchers and journalists using this data to understand more about the health care system, ask important questions about physician practice patterns."

When asked about data sets to be released over the rest of the year, Brennan somewhat demurred, stating "I hesitate to try and forecast too far in the future what we're going to release because our priorities are changing all the time" and that they are "releasing so much data now that the annual re-release cycle is consuming more and more of our time." He is, naturally, hoping to continue making "inroads" on the number of Medicare provider releases for fee-for-service spending.

October 02, 2014

Physician Payments Sunshine: Columbia Seeks to Join Global Transparency Trend


The Colombia Ministry of Health and Social Protection recently published a draft law which would require pharmaceutical and device manufacturers to disclose their payments and in-kind transfers to “those who participate in any manner in the provision, insurance, or education in the health sector.” The reports will be made public on a searchable database.

Columbia follows a long list of countries that have reporting laws, including the U.S. Sunshine Act, EFPIA in the European Union, and the French Sunshine Act.

View Columbia's draft resolution (translated to English) here

“[M]any pharmaceutical companies operating in Colombia already disclose information in their home countries and other countries in which they conduct their operations,” Columbia notes in their resolution (emphasis added).  The draft does not specify whether the reporting obligations would be restricted to companies “operating in Colombia,” nor does it describe what is meant by “operating.” 

If the draft resolution is finalized, the Ministry provides that "voluntary registration" and reporting of payments would start January 1, 2015. This initial disclosure would only relate to “general information about the payments.” Registration and reporting of payments would be mandatory starting January 1, 2016, and would require “information identifying the recipients.”  

The draft resolution states that the "invitation to register" applies to manufacturers, distributors, importers, traders, or participants in the supply chain of drugs, supplies, devices, and medical equipment or any other health technology. 

These parties must report on payments made to health practitioners that perscribe health services. Furthermore, the draft law requires reporting on payments made to virtually anyone remotely involved in healthcare: administrative staff that work in the health sector, professional organizations, associations, clinics, hospitals, universities, students in healthcare fields, patient organizations, and patients, among others. 

Manufacturers and distributors must submit direct payments and transfers of value of any type, including those made in cash and in kind. The draft includes a non-exhaustive list, which includes:

  • funding attendance at medical, academic, or scientific events
  • funding for meals and other recreational events
  • payments for patient monitoring
  • funding for research
  • medical continuing education activities
  • medical equipment

Thus, Columbia's law explicitly states that many transfers of value that are excluded under the U.S. Sunshine Act are to be reported on in Columbia. The only four exceptions are as follows (interestingly many dollar thresholds are in proportion to the minimum wage, which works out to a monthly wage of COL$589,500 (US$333)):

  1. Payments by parties obligated to register made to someone with a employment or contractual relationship to develop the social objective of the activity of the payer shall not be registered.
  2. Medical samples or diagnostic tests shall not be registered "unless their individual market value exceeds four minimum wages (SMLMV)."
  3. Printed promotional information shall not be registered unless it is part of a continuing education or recreational activity.
  4. Transfers of value of less than half (1/2) a monthly legal minimum wage need not be registered, unless they exceed one monthly legal minimum wage in one year. 

Reporting entities must then consolidate their payments into categories (such as food and drink, research, gifts). These are almost identical to the US Sunshine Act categories. The reports must also include the "form" of payment--cash, in kind items, stocks. 

As noted above, the current draft contemplate different stages for implementation. The first stage will last one year and include two registrations--first, payments made during the first half of 2015 will be completed before October 31, 2015. The second registration will cover payments made in the second half of 2015 and will be completed before April 30, 2016. 

The second phase will be mandatory, and requires individual, non-aggregated payment reports. It is slated to begin January 2016 and its rules will remain in place going forward, with reports required before April 30 each year. Notably, "[t]he only payments that will not be individually identified are those given to patients and the registry will maintain the aggregate amount," the draft states. "Those that are transferred to patient associations shall be reported individually."


We will continue to follow updates on Columbia's disclosure law, as well as other Sunshine initiatives. View our coverage of the Open Payments release here

In the meantime, Columbia provides a fairly succinct answer to most disclosure inquiries we could think of: "In case of a question as to whether a payment or transfer of value should or should not be registered, it shall be registered."  


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