Topic 22: We Read the Sunshine Act Rules So You Don’t Have To - Part 2

This is the second part of my review of the Sunshine Act rules.  You can read all of the exciting  282 pages  here.  The first part of this analysis is here.

There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

• Exclusions for Existing Personal Relationships (eg. husband [Pharma employee] give wife [physician] a string of pearls) will remain.  Pg. 111

• Exclusion for transfers of $10 or below assuming that such transfers do not add up to over $100 during the course of the year remains in effect and the $10 amount will not be raised until 2014. Pg. 112

• Small incidental items under $10 (eg. notepads, magnets) that are provided at large-scale conferences or events are exempt from tracking including for aggregate purposes. Pg. 114

• Items intended for patient education will be excluded, even when they hold some potential alternative value for the physician (eg. providing a thumb drive containing patient education material). Pg. 116

• Education materials that are targeted directly at a physician (eg. reference manual, text book) are not included in the patient education exception and thus their value must be tracked and reported. Pg. 117

• The exclusion for “in-kind” value provided to a physician supporting the physician’s ability to provide “no charge” services to patients who cannot afford them includes patients that cannot afford the co-pay as well as patients simply unable to pay. Pg. 119

• The exclusion allowing the short-term loan of a device has been clarified to be for only 90 days or less, even if the device is disposable and not used during the 90 days.  Additionally, the short-term loan is for a total of 90 days during a year, not a series of 90 day loans.  Pg. 122

• Physicians that receive value as subject in a clinical trial do not have to have that value reported since they receive that value in their role as patient not physician.  Pg. 123

• Indirect transfers of value or payments do not need to be tracked if the manufacturer is not aware of who the third-party they pay is providing value to.  If they are aware who the third party if providing value than they do need to report that value. Pg. 128

• Indirect payments do have to be tracked if the manufacturer provides it with instructions that would lead it to be given to a covered physician.  For example, if a manufacturer provides a payment to a teaching hospital specifically to provide grants for research, that manufacturer would need to report who received the grants even if they are not involved in deciding who will receive the money.  If they provided the money to the same teaching hospital but put no restrictions on that money and the hospital decided to use some for grants they would not have to report it.  Pg. 131

• Indirect payments where the manufacturer is not able to be aware of the payment recipient are excluded from reporting.  For example if a manufacturer hires a market research company to provide double-blind market research, they cannot know who received the value and as such they do not need to track the indirect payments. Pg. 134

• Indirect payments that result in reporting are to be tracked for two quarters beyond the payment year.  For example if a teach hospital is given money for grants in March of 2013, it must track that money through the end of Q2 2014.  Money dispersed after that point does not have to be tracked.  Pg. 136

• When industry funds CME, the speaker payments do not need to be tracked if the following is true 1) the CME events meets the ACCME, AMA or other major certification requirement, 2) the manufacturer does not provide suggested speaker names or even a list of suggested names/qualifications, 3) the manufacturer does not pay the speaker directly.  Pg. 140

• When industry pays to subsidize the accredited CME attendees tuition fees it is exempt from reporting. Pg. 140

• Payments make in connection with prescriber education beyond materials that is required by REMS must be reported like any other educational value provided. However, the value of “Dear Doctor” and other education materials is excluded.  Pg. 141

• There is quite a bit about the definitions of stock and option ownership and investment interest that I am not covering in detail because I don’t think it relates extensively to MA.

• While not required, the rules suggest that prior to report submission the individual physicans are provided with a report of what information is going to be sent in the report to provide them with an opportunity to make corrections.  Pg. 156

• Reports are due by the end of Q1 of the following year. Pg. 157

• Reports are to be accompanied by attestations of accuracy by the CEO or similar top company officer.  Pg. 164

• Physicians and teaching hospitals will be notified that a new report is available and open to be reviewed and corrected generally through web postings at CMS, and directly if they register with the CMS ahead of time. Pg. 171

• Physicians will be given 45 days after notification and before publication to go online and review the data about to be published and submit corrections. Pg. 172

• Manufacturers only have 15 days after the 45 day review period to correct their data and resubmit to CMS.  Pg. 173

• To receive the data for review, physicians will need to register and validate their identify. Pg. 174

• Physicians who dispute the data provided by a manufacturer in their name must resolve the issue directly with the manufacturer.  The physician will be able to enter their suggested correction in the CMS database and CMS will provide the suggested correction to the manufacturer but will not be engaged in issue resolution. Pg. 180

• If the physician and the manufacturer cannot come to an agreement within the 15 day correction period, the transaction will be marked as disputed but the manufacturer’s original data will be displayed.  Pg. 184

• The CMS will update the database at least once after the initial publication to reflect corrected data that arrives after the initial correction period. Pg. 185

• Reporting on payments made to support development of new drugs, devices, biologics or medical supplies can be delayed until FDA approval or 4 calendar years, whichever comes first. Pg. 194

• The delayed reporting is only applicable for new drugs, any development of new indications on existing approved drugs is not subject to the delay. However, new generics will be considered new drugs for reporting purposes. Pg. 196

• Reporting is required even for products that fail in development, after the 4 year time period has expired. Pg 198

• Delaying the report of value provided for new drug development is optional – the manufacturer still has to report the amount of value provided and then may choose to request that the reporting be delayed.  Pg. 199

• Information will be maintained on the CMS databases for 5 years after publication date. Pg. 206

• The new Federal rules will pre-empt state reporting rules after the Federal rules go into effect. Pg. 211

• Rest of report is Federal administrative analysis, not relevant in terms of rule execution.

I will analyze what this means for MA leaders and their team in a subsequent post.  Please leave your comments below.