Life Science Compliance Update

July 26, 2017

Ontario Enters the Transparency Spotlight

Transparency-business

Over three years ago, the Toronto Star filed a freedom of information (FIPPA) request with the Health Ministry in Ontario, Canada, seeking physician-identified data on the top 100 billers. Last year, the information and privacy commissioner ordered the disclosure of the top billers’ identities, along with amounts each receives in payments from the taxpayer-funded insurance plan.

The Health Ministry allowed partial access to the Star, including payments and most medical specialties, withholding physician names. The Ministry withheld the names as it determined releasing the names would be an “unjustified invasion of privacy.”

However, two groups of doctors, along with the Ontario Medical Association, fought the disclosure all the way to Ontario’s Divisional Court. The three-judge panel dismissed an application to quash the aforementioned order from the Information and Privacy Commissioner. The panel ruled that the order was a reasonable one, and that the ministry shall release the names of the highest-paid physicians public.

The groups opposing the release of information argued that an adjudicator with the Information and Privacy Commissioner erred in departing from previous commission orders that found such information was personal. That adjudicator, John Higgins, concluded that physicians receive OHIP payments in relation to their business or profession. Further, he noted that the money does not reflect the actual income of the physicians, because doctors pay overhead expenses out of the payments received.

The lawyers argued that,

The adjudicator’s determination that the information being sought was not ‘personal information’ is wrong as a matter of both fact and law and is clearly unreasonable. While he recognized the existence of those prior determinations … he chose to ignore or distinguish them on specious grounds while ignoring the overwhelming weight of authority they supply.

They also argued that publishing the names of the top billers “accomplishes nothing other than naming and shaming.” The lawyer for the groups argued in front of the judges – “who really cares what the names are? The question is whether or not the ministry is properly administering a multibillion fund and whether the question of the proper operation of that fund…can be accomplished without disclosing names.”

The Court rejected the argument made by the doctors that the Star had failed to establish a proper rationale for the disclosure. It found that the argument ignores the well-established rationale that underlies access to information legislation. The decision states, “[t]he rationale is that the public is entitled to information in the possession of their governments so that the public may, among other things, hold their governments accountable.”

Justice Ian Nordheimer stated that the Star did not even need a reason to obtain access to the information. The FIPPA requires that the information be provided unless a privacy exemption is demonstrated. However, once it is determined that the information is not personal information, there is no statutory basis to refuse to provide it. The decision further notes, “The proper question to be asked in this context … is not ‘why do you need it?’ but rather ‘why should you not have it.”

This ruling will affect other Information and Privacy Commissioner cases, including an appeal made by the Star, seeking the release of physician-identified billings for all Ontario doctors. The Commissioner previously put this appeal on hold, pending the outcome of this case.

July 03, 2017

CMS Releases 2016 Open Payments Data

Slide2

2016 Open Payments Data was released on Friday, June 30, 2017. In 2016, the total dollar amount of payments totaled $8.18 billion. The total amount of general payments made amounted to $2.80 billion; the total amount of research payments amounted to $4.36 billion; and the value of ownership or investment interest totaled $1.02 billion.

Where Did The Money Go?

The $8.18 billion was given to 631,000 clinicians and 1,146 teaching hospitals. Drug and device makers are required to report any “transfer of value” of $10 or more, or transfers of value that add up to more than $100 per year.

Roughly 75% of the $2.8 billion ($2.07 billion) in general payments went to clinicians, including physicians, dentists, optometrists, podiatrists, and chiropractors. Teaching hospitals received $724.51 million in general payments.

Research payments largely went to teaching hospitals: $867.95 million, compared to the $95.21 million that went to physicians. The physician research payment total includes payments where the company making the payment has named a physician as the primary recipient, as well as payments to a research institution or entity where a physician is named as a principal investigator on the research project.

Year to Year Comparisons

The below tables show comparisons of different data points over the past few years.

1

The above table compares the percent change in total payments and records. The percent change in payments and interest from 2015 to 2016 totaled 1.11% ($8.09 billion to $8.18 billion).

2

The above table compares the percent changes in three different payment categories: general payments (4.5%); research payments (-2%); and ownership interest (6.3%).

3

The above table compares the 2014 to 2016 change in number of companies reporting (-8.24%); physicians receiving payments (.96%); and teaching hospitals receiving payments (1.69%).

Medscape joined the “fake news” craze, by stating the increase was 8.8% from last year’s payments. However, the actual rise was less than 1.1%.

Conclusion

Visitors to the CMS Open Payments website can look up individual clinicians and hospitals to see what they have received from drug and device makers and compare their payments to national and specialty averages.

June 29, 2017

Chicago Releases Pharmaceutical Representative Disclosure Log Draft

EDetailing1

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.

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