CBI’s recent Forum on Transparency and Aggregate Spend covered a variety of topics affecting the collection and reporting of aggregate spend data. The conference featured speakers from industry, government agencies, and service providers sharing lessons learned and best practices related to aggregate spend collection and data disclosure.
After a day of pre-conference workshops, the main conference began on Day Two, and it started with a bang. The keynote address, An Update on Open Payments Reporting, was delivered by Doug Brown, CMS Group Director, Data Sharing and Partnership Group, Center for Program Integrity. Mr. Brown shared statistics on the data submitted for the 2014 reporting year. 11.4 million records were received, covering 600,000 individual physicians. In a vast improvement over the previous year, 98% of submitted records were accepted. Brown attributed this improvement to the introduction of the validated physicians list (VPL) and better data matching. An analysis of rejected records is underway, and CMS is looking for ways to improve the taxonomies associated with covered recipients.
During the review and dispute period, CMS received 30,000 disputes on 25,000 unique records. The disputes were evenly distributed among the covered recipient type, with physicians representing 35% of disputes, teaching hospitals 38% and principal investigators 27%. According to Brown, disputes were evenly split between the general and research payments reports. Very few disputes were lodged against payments reported on the ownership report. The median value of total payments is 4.5 times greater for registered physicians versus unregistered physicians.
Brown also shared information regarding the anticipated enhancements to the Open Payments system. The restrictions around special characters in the text fields will be removed (cue the heavenly choir). CMS is also working to better facilitate the review and dispute process. According to Brown, many of the disputes were not true disputes, but could better be classified as inquiries. CMS is working to provide a method for distinguishing between a payment inquiry and a payment dispute. The agency is also working to enhance the ability for manufacturers to download their data from the site, regardless of the file size, and it hopes to extend this capability to covered recipients as well.
Brown reminded the group that new de minimums payment information and the list of teaching hospitals will be released on October 1st. CMS is planning more Q&A teleconferences in the future. Speaking of which, during the Q&A period following the presentation, Brown was asked about having a moderator on teleconferences to alleviate the “wild west” that currently exists when the call opens up for participant questions. He said that was something he would absolutely consider, but he prefers the conversational style of the current format.
William Killian, U.S. Attorney for the Eastern District of Tennessee, and Jacob Elberg, Chief, Healthcare and Government Fraud Unit, of the U.S. Attorney’s Office for the District of New Jersey, also presented on behalf of the government. They discussed current trends in government enforcement. Mr. Killian said emerging enforcement trends in his and other offices involved fraud related to Medicare Part D, lab services, hospital services and hospice care. He noted that the civil and criminal prosecutors are often involved in parallel prosecutions. Mr. Elberg referenced a continuing trend in his office involving the prosecution of kickback cases. He said those cases are typically at the individual practitioner level, and occur locally or globally. Cases that involve activities outside the U.S. can implicate the FCPA and his office shares information with FCPA fraud units. Elberg also discussed other continuing trends involving FDCA prosecutions, including those involving off-label promotion and cGMP violations.
Rounding out the “law-focused” presentations for the day was a presentation about state laws by Brian Bohnenkamp of King & Spalding. Mr. Bohnenkamp led off by discussing federal pre-emption and how it relates to state reporting. He noted that there are times where the reportable items under federal law are not reportable under state law (and vice versa), and reminded the audience of the criteria for pre-emption under the Sunshine Act. He suggested that decisions on whether pre-emption should be applied to a particular payment should be made on a case-by-case basis. He also noted that they are seeing more companies take advantage of federal pre-emption in reporting under state laws, and used the example that a number of companies did not have anything to report under Minnesota’s law due to that pre-emption. Bohnenkemp also highlighted the recent exemption in D.C.’s detailer licensing requirement for individuals who are involved in detailing for “less than 30 consecutive days per calendar year,” and he reviewed prescription drug pricing transparency proposals in a handful of states – one example being Massachusetts, which still had not provided guidance about quarterly meal reports reported under that state’s law.
The majority of the rest of the Day Two sessions focused on data and processes directly related to interacting with the Open Payments system. Sessions and panel discussions covered topics such as leveraging the data within the organization; using data to minimize compliance risk; and remediating data and the data attestation in Open Payments. Two key themes emerged: 1. Clean data is key (the garbage in garbage out idea) and 2. Communication with the organization and those outside the organization (your vendors and physicians) about the data is critical.
A number of speakers and panelists in the sessions stressed the importance of consistency in names, addresses, and format for physician ID numbers across the various in-house and vendor systems that house spend data. A periodic review of the data is an important best practice to deal with any issues along the way. Most panelists and speakers felt that a quarterly review was an achievable goal. More frequent reviews would be ideal, but could prove a challenge for companies with fewer resources. In addition, companies should engage the business early and often about what the data reveals and how that information can be leveraged to reduce risk and impact sales. Communication with physicians in advance of the CMS review and dispute period was recommended. This does not necessarily mean disclosing all the data, nor pre-disclosing to every physician about whom you have data. Setting a minimum TOV threshold for pre-disclosure, or pre-disclosing only to select KOLs were suggested as means of making the pre-disclosure beneficial to both the physician and the company.
Speaking of physicians, Day Two included a panel discussion moderated by PhRMA Executive Vice President and General Counsel, John Murphy, on the physician’s perspective of Open Payments. Panelists included Dr. Maya Babu of the Mayo Clinic and AMA Board of Trustees member, and Dr. David Barbe, former Chair and current member of the AMA Board of Trustees. The panelists said the main concerns of physicians are centered on the potential for bad data being presented to public, the ability for physicians to access the data, the implications of the data, and the impact the Open Payments program will have on relationships with the industry. While there have been improvements in the registration process, there are still issues with access, specifically, problems with particular browsers being able to access the site. The panelists felt strongly that being able to access the data through a site set up by the manufacturer would be helpful, or even having a sales rep provide the data personally.
The United States certainly hasn’t cornered the market on physician spend transparency. Global transparency was addressed on Day Two, predominately in a discussion group at the end of the day. On Day Three an entire morning track was dedicated to issues related to global transparency. The featured presentation (and highlight of the conference) was an address by Andrew Powrie-Smith, Director of Communication for the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Mr. Powrie-Smith briefly covered the nuts and bolts of the EFPIA Disclosure Code before turning to a discussion of transparency in general. The industry believes transparency is about demonstrating that there is value in the collaboration between industry and healthcare professionals/organizations, which ultimately delivers better patient care. However, being transparent is not without its challenges. Primarily, with the exception of countries, such as France, where there are physician spend disclosure laws, managing transparency efforts in face of the EU privacy laws is challenging. The EFPIA Disclosure Code requires the disclosure of certain transfers of value at the individual practitioner level, and requires that disclosure to be made available to the public. In order to meet these requirements, companies must obtain consent from physicians to disclose private information about them. Further complicating the matter is that even if consent is given, it can be revoked at any time.
Mr. Powrie-Smith said EFPIA is currently conducting a survey regarding the industry stance on obtaining the necessary consents for disclosure of transfers of value at the individual level. Thus far, EFPIA has seen a large variance in the rate of consent across Europe. A culture shift is necessary to address the variance and the industry must take a leadership role in that shift.
The concept of gaining and managing consent was emphasized in other presentations as well. Representatives from BMI Systems shared data on the rates of consent presented by various pharmaceutical industry trade organizations at an EFPIA meeting in May. In Germany, the consent rate was 50-55%, and the industry trade organization in the country said that was about what they expected for the first year. Poland’s trade organization noted in March they were at a 20% consent rate, and Spain’s trade organization reports only a 10% consent rate. Representatives from IMS Health dug into issues with gaining consent as well. They discussed how codes and laws differed from country to country, specifically regarding the timelines for obtaining consent (e.g., at time of contract, or at any time during the reporting period); the scope of the consent (e.g., per activity type, per contract); from whom consent is required (e.g., HCPs or HCOs); and required consent documentation (paper or digital).
The 9th Annual Forum on Aggregate Spend and Transparency offered useful information for any attendee responsible for data collection, report submission, or analytics inside or outside the U.S. Beyond the nuts and bolts of aggregate spend, the presentations focused on the value of the data for the organization and the physician. Data provides insight for commercial teams and their programs, and the compliance risks for the company. Most importantly, as communicated by Andrew Powrie-Smith, transparency around spend data is important, because it reveals the benefits of the industry/HCP relationship to patients, payers and the public.