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31 posts from March 2015

March 31, 2015

CMS: Open Payments Data Submission and Attestation Period Open until Midnight April 3, 2015

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The Centers for Medicare and Medicaid Services (CMS) has just announced that the Open Payments data submission period will remain open until midnight (Eastern Standard Time) on Friday, April 3, 2015 to accommodate all applicable manufacturers and group purchasing organizations (GPOs) that are in the final stages of data submission.

The Open Payments system is scheduled to open for review and dispute on April 6, 2015. This will be the start of the 45-day review and dispute process for physicians and teaching hospitals, which occurs after applicable manufacturers and GPOs submit their payment data to CMS and before the data becomes public. The review process is voluntary, but to participate in the process and review and correct the data, physicians and teaching hospitals will need to register in both the CMS Enterprise Identity Management System (EIDM) and the Open Payments system.

According to one consultant the help line at CMS has been tied up all day and there have been several glitches, causing delays in submissions.

View our comprehensive article of Open Payments Year 2 data submission here

Open Payments Submissions Due Today, March 31; Vermont Reports Due Tomorrow, April 1


Manufacturers must submit their Open Payments reports to the Centers for Medicare and Medicaid Services (CMS) today, March 31. These records cover payments or other transfers of value from pharmaceutical and medical device companies to healthcare professionals given in 2014. This second year submission process is unique in that it covers an entire year of payments, rather than only five months’ worth, as was the case in the first round of Open Payments reporting. 

Yesterday evening, CMS sent out an email confirming the deadline:

Tomorrow, Tuesday, March 31, 2015, is the final day for applicable manufacturers and group purchasing organizations (GPOs) to submit and attest to 2014 program year data and update 2013 program year data for publication by June 30, 2015. Complete your reporting entity’s data submission and attestation activities by logging into the Open Payments system through the EIDM Portal.

If you submitted data for the 2013 program year but have not yet begun the process for the 2014 program year, you will need to recertify in the Open Payments system before you can begin any 2014 submission activities. Use the Applicable Manufacturer and GPO Registration and Re-Certification – Quick Reference Guide [PDF] to help you complete this necessary step.

Lessons Learned, But Issues Remain

The initial Open Payments roll-out last year was problematic for manufacturers and physicians/teaching hospitals alike, and ultimately resulted in thousands of payment records being "de-identified" or outright removed from the database. CMS has attempted to fine tune the submission process by improving upon the matching formula used to verify a physician’s or teaching hospital’s identity as manufacturers attempt to enter their information into the system.

In addition to modifying the data matching algorithm for covered recipients, CMS also developed a Validated Physician List--a master list of their data. “To proactively assist with data matching, and in an effort to be fully transparent about the method and data sources used to validate submitted data, CMS is publishing a downloadable list of physician data in CSV format, which contains variations of physician first/last name, NPI and state license number, for physicians who were reported in the Open Payments system," CMS states. “This Validated Physician List is accessible in the Open Payments system via the CMS Enterprise Portal. CMS encourages applicable manufacturers and GPOs to utilize the provided physician list to avoid further inconsistencies in data reporting.”

While CMS’s efforts to improve the data submission process are appreciated, various consultants in the Open Payments space have indicated that CMS continues to use outdated physician and teaching hospital information for matching purposes and that the Validated Physician List has some gaps in the data. Several users have raised the issue that CMS has physicians still listed as a “student,” despite the fact that the physician is actively licensed by a state, for example. The result is that many HCPs are not being validated even by CMS’s updated matching logic, forcing at least one large aggregate spend firm to remove anywhere from 5-15 percent of the physicians, depending on the manufacturer.

Other issues include the fact that CMS has taken Open Payments offline on a number of occasions, including as recently as March 27. Companies have also reported challenges with submitting their corrections from last year, or continuing to delay publication of research payments. Manufacturers may request delayed disclosures related to research payments for investigational products in order to maintain confidentiality. These payments must be reported once the product receives FDA approval or four years have passed since the payments were made, whichever comes first.

Updated 3/31, 9:20 am: In addition to especially slow system performance in the last day of reporting, we have heard reports of zip codes being erroneously cleared out of covered recipient addresses in the submission stage. Another issue concerns how to report research spend to a teaching hospital with a physician principal investigator when the physician was (incorrectly) not included on CMS's master list.  CMS has addressed this fact pattern for general payments, through the separate deleted file process described in the next section, but has not given guidance on whether it is better to report the research spend to the teaching hospital on-time with no principal investigator or to load the files separately and remove them, as CMS instructed for general payments. 

CMS Call

During a call with manufacturers a few weeks ago, Doug Brown, Director of the Data Sharing and Partnership Group at CMS, stated that even given Open Payments’ revamped matching process, a situation may still arise where (1) a physician is not on CMS’s validated physician list, and (2) when companies submit the seemingly correct information, it is still being rejected by the system. “If we have a record that has an NPI, state license, and first and last name, and CMS cannot validate it using NPPES and PECOS,” than the system will not accept the record, Brown stated. ”So, there will be records attributable to covered recipients that the system will not be able to accept.”

Brown notes that he “does not want this to be something that "comes up down the road in an audit.” To avoid problems during an audit and resulting Civil Monetary Penalties, Brown advised companies to separate out the physician records that are problematic and that have been rejected. He stated that companies should separately submit all of the physician records that the system accepts, and attest to these. For the rejected pile of records, companies should nonetheless upload these records, which will be rejected, and then delete the entire file. Brown stated that Open Payments has a traceability capability that saves a lasting record that the company has submitted this file. Thus CMS will know that the company submitted transfers of value about individuals, even if there were problems with the ultimate submission process.

“Even when you delete the entire file, we do retain a record of this transaction actually occurring. And we can then look back later on, before contemplating any audit or any CMP action to make sure we have a firm understanding of those records that you attempted to report about," Brown states.

Vermont Reports Due April 1

Open Payments is just one aspect of reporting that manufacturers must juggle this spring. Vermont reports are due April 1 as well. 

Unlike the Federal Sunshine Act, which requires disclosure of certain payments, Vermont law bans most gifts from manufacturers to healthcare professionals. This means manufacturers must be weary of payments made to any prescriber practicing in Vermont to make sure such transfers of value due not break the state law.

View Vermont's guide to its law here

For any "allowable expenditures and permitted gifts," manufacturers must disclose these amounts to the state's Attorney General. Importantly, Vermont's list of reportable "covered recipients" is more expansive than the Federal law, so as not to be pre-empted. Indeed, the “Prescribed Products Gift Ban and Disclosure Law” applies to a broad list of “health care providers” (HCP), that includes a “health care professional, a hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase for distribution prescribed products in Vermont.” Vermont law also requires manufacturers to disclose the distribution of samples of prescribed products to Vermont HCPs. 

Vermont has been very active on enforcement of its gift ban and disclosure law this year, and does not seem to be letting up even after the Federal Sunshine Act has come into effect. View Vermont's list of enforcement actions

Next Up For Open Payments: Physician Review and Dispute

CMS is hosting a webinar on April 15, entitled “Prepare to Review Reported Data” targeted at physicians, teaching hospitals, and physician office staff heading into the review and dispute phase of the Open Payments cycle. 

During the call, CMS will provide a brief overview of the Open Payments program and highlight the parts of the program timeline when it is most critical for physicians and teaching hospitals to be aware and get involved. The call aligns with the beginning of the program phase when physicians and teaching hospitals are able to enter the Open Payments system and review the accuracy of data submitted about them, prior to the publication of this data on the CMS website.


Provide your insight into the Open Payments submission process, or offer any issues in a comment below. 

March 30, 2015

New Zealand Transparency Advocates Call For Sunshine Act

New Zealand

A group of transparency advocates in New Zealand has been writing various articles on the value of “more Sunshine” for a while now. Last Friday, they made their campaign more official with an editorial in the New Zealand Medical Journal.  In it, a collection of five academics and doctors argue that New Zealand needs a Sunshine Act comparable to the United States.

"Whilst several countries are enacting legislation to tighten requirements for disclosure ... the situation in New Zealand remains as murky as ever,” state the group of writers, led by Cindy Farquhar, a professor at the University of Auckland in obstetrics and gynecology, and co-chair of the Cochrane Collaboration.

"It is not uncommon for doctors and researchers to receive payment for membership of advisory boards, speaking at industry-sponsored symposia, or sponsorship of travel to and accommodation at conferences, which often incorporate generous hospitality events and may not involve any speaking commitment,” state the authors. The editorial also targets clinical guidelines, given their key role in supporting clinical decision-making.

In addition to Professor Farquhar, the authors of the editorial included: Tim Stokes, Elaine Gurr Professor of General Practice & Rural Health, Dunedin School of Medicine, University of Otago, Dunedin; Andrew Grey, Associate Professor of Medicine, University of Auckland; Mark Jeffery, Medical Oncologist, Canterbury Regional Cancer & Haematology Service, Christchurch Hospital, Christchurch; and Peter Griffin, Manager, Science Media Centre, Royal Society of New Zealand, Wellington.

Last year, Professor Farquhar spoke on the issue of physician payments in a presentation entitled “Does New Zealand need a Sunshine Act?” She stated that doctors are receiving gifts and benefits from industry without having to declare them, including conference travel not related to speaking and generous hospitality. Farquhar argued that such hospitality is “generally aimed at leaders in their field,” including academics, clinical directors, and prominent doctors. She listed a number of examples in her presentation, such as a recent conference in the US where several doctors from New Zealand received free travel, hotel, meals, and conference registration valued at $6,000 per person.  She also critiqued a recent New Zealand conference where the sponsor "hosted free evening function for all the clinicians (not the epidemiologists!) which was not on the conference programme,” with an “estimated costs per person $180 X 300 = $54000.”

Farquhar is critical of Medicines New Zealand, the country’s pharmaceutical industry association. New Zealand policy is “soft” because it is self-regulated and non-transparent, she argues. She noted that “hospitality at conferences is alive and well,” and “offers of free travel to meetings/symposia are plentiful.”

In December last year, Medicines New Zealand noted that disclosure of payments from pharmaceutical companies to clinicians would be complex and resource-intensive, as reported by New Zealand's "Pharmacy Today" publication. But the association "stopped short of saying New Zealand should not have a Sunshine Act, and said it wanted to be more involved in discussions." Heather Roy, chair of Medicines New Zealand, stated that the industry's "Code of Practice already has rules around gifts and payments from pharmaceutical companies to healthcare providers" and that the "primary objective of interactions between members and healthcare providers must be to improve patient care, by increasing medical knowledge and enhancing the quality use of medicines."

In addition to disapproving of Medicines New Zealand, Farquhar was also critical of Medicines Australia, which even added a transparency reporting requirement to its code last year. Farquhar stated that Medicines Australia considered "making mandatory reporting how much pharma spends on hospitality and advisory boards," but included an "opt out" for health professionals. Indeed, like much of Europe, Australia is concerned with physician consent before publicizing personal information. According to the new code provisions, "[I]f a healthcare professional does not agree to the information being disclosed with their name, the expenditure will be reported in aggregate with the number of healthcare professionals it relates to."

Read Medicines Australia's description of their updates to the code, including the reporting provisions, here

An editorial in New Zealand Medical Journal is certainly no Sunshine Act, but the push for transparency--and almost an "expectation" of companies to report physician payments--has taken hold worldwide. Articles in various New Zealand news outlets have steadily been drumming up the importance of more disclosure. It is not difficult to imagine, given the EFPIA disclosure code in Europe, Medicines Australia's transparency updates, and a host of other international "Sunshine" developments, that New Zealand could soon be the latest to join the club. 


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