Life Science Compliance Update

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.

May 17, 2016

Growing Like Weeds - MedTech Europe Adopts New Code of Ethical Business Practice

Europe adopted a new Code of Ethical Business Practice late last year. This article explores the purpose of the new Code, standards found in the new code, as well as some material differences between this new Code and other Codes currently in existence.

The February issue of Life Science Compliance Update ("Update") reviewed a new code of conduct from the European Generic Medicines Association (EGA) In the March issue, the Update highlighted and compared some the major codes life sciences compliance officers regularly deal.

Now it appears that there is yet another new code that at least medical device compliance officers need to consider. On December 2, 2015, members of both the European Diagnostic Manufacturers Association ("EDMA") and the European Medical Technology Industry ("Eucomed") approved a new Code of Ethical Business Practice. Both associations are members of MedTech Europe who is working to raise the ethical standards of the medical technology industry all throughout Europe.

The full text of this article is available in the May 2016 Issue of Life Science Compliance Update

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May 09, 2016

Medicines for Europe Adopts Physician Payment Reporting Requirements Starting 2017

The European Generics Medicines Association is undergoing a "rebranding" of sorts. They recently changed their name to "Medicines for Europe," and have expanded into value added medicines, "aimed at optimizing, rethinking, and reinventing existing medicines based on known molecules, addressing unmet medical needs of patients through improved care delivery systems."

In addition to the aforementioned changes, Medicines for Europe also recently published their Code of Conduct, which requires reporting for physician payments starting in 2018 for payments made in 2017. The Code is similar to the EFPIA Code, and in 2018, there will be one system for Europe.

Disclosing Transfers of Value

The Code requires that Medicines for Europe member companies disclose Transfers of Value that "could potentially pose a conflict of interest, or to encourage the recipients of the transfers of value to disclose them, where such disclosure would be in the best interest of patients or the public." Such mandated disclosures also include Transfers of Value made by a third party on behalf of a Medicines for Europe member company for the benefit of a recipient, when the Medicines for Europe member company knows about the recipient who will benefit.

Transfers of Value to be reported are allocated to different categories under the Medicines for Europe Code. Any Transfers of Value that are not listed in the Code are not required to be disclosed.

Transfers of Value to Patient Organizations

These transfers, made up of both financial and in-kind support, shall be disclosed on an individual, named basis. The reporting shall include fee for services, including a description of the nature of the Transfer of Value and the amount provided.

Transfers of Value to Healthcare Professionals

This includes fees for services and for consultancy: aggregated honoraria paid by a Company to a Healthcare Professional in exchange for providing services (not including meals, drinks, travel, and accommodation). These may include items such as: serving as an expert on an advisory board, speaking at a company-organized educational event, or participating in a focus group. Fees paid in connection with research and development are not included with this group.

Meetings, Educational Support, and Site Visits

For these forms of Transfers of Value, members have their choice of one of two options for disclosure.

Option one: member companies must report the total number (not actual monetary value) of events, for which individual healthcare professionals have received support. Support shall be disclosed per individual healthcare professional in the following categories: sponsorship for attending a third party organized congress (must be indicated whether the event is local/domestic, within Europe or outside of Europe); site visits; and company organized meetings for which a healthcare professional receives company funded hotel accommodation and/or airplane travel.

The second option requires companies to report the aggregate total amount of support provided to healthcare professionals per individual conference or meeting as follows: sponsorship for attending a third party organized congress (including the name of the congress, the aggregated amount spent for the congress, and the number of healthcare professionals financially supported to attend); site visits (including the aggregated amount spent and the number of healthcare professionals financially supported to attend); company organized meetings (including the aggregated amount spend and the number of healthcare professionals financially supported to attend); and transfers of value to healthcare organizations (including fees for services and consultancy and the aggregated monetary amounts of any grants or donations, along with a brief description of the nature of the grant or donation).

Additional Requirements

In addition to its disclosure, each Medicines for Europe member company shall publish a note summarizing the methodology they applied in preparing the disclosure and identifying Transfers of Value for each category. It is recommended that companies include the VAT and any other taxes in the disclosure amount, as required by local laws and regulations. Companies are also advised to make their disclosures in Euro and local currency.

Other Sections including Hospitality

Other sections of their newly adopted code of conduct include that companies can only pay for coach class tickets on flights for conference attendees, consultants and speakers except for exceptional circumstances and a prohibition on stopovers. Consulting payments must be made at fair market value. They adopted a prohibition on standalone hospitality and entertainment. A ban on luxury hotels, resorts, venues known for their entertainment or recreational value, or extravagant venues even if they cost less than normal hotels or venues.

The criteria for supporting educational events includes:

  • Therapeutic areas of interest to the company;
  • Healthcare Professional's expertise, knowledge, experience, areas of scientific or medical interest, and related educational needs;
  • Geographic location of the Healthcare Professional and distance to the educational event;
  • Alternative educational opportunities;
  • The reputation, means and need of the institution employing the Healthcare Professional;
  • Reputation and standing of the Healthcare Professional in the scientific or medical community
  • Experience with a company's products may be considered in connection with company-sponsored third party events and company-Organized Meetings;
  • Potential impact on the quality of patient care; and
  • The ability, willingness and likelihood of the recipient to further share the knowledge gained with others.

Of Note

This reporting requirement differs from the Code promulgated by MedTech Europe (an alliance of European medical technology associations, formed by EDMA and Eucomed), which does not require reporting. It will be interesting to see if reporting requirements and transparency start to become newsmakers in the medical device and medical technology world the same way they have in the pharmaceutical world.

Helpful Documents

Medicines for Europe Code of Conduct

Medicines for Europe Code of Conduct Q&A

Medicines for Europe Enforcement Guidelines


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