Life Science Compliance Update

August 19, 2016

New Jersey Interactive “Transparency” Map

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NJ Spotlight, a website that highlights “news issues and insight for New Jersey” recently created an interactive map of New Jersey doctors who received transfers of value from industry in 2015. The map, which can be found here, allows interested readers to see payments by zip code and details on those doctors who received the most money on the map, in addition to individual payments to doctors by searching the databases that are arranged by last names.

According to the United States Centers for Medicare and Medicaid Services (CMS), New Jersey doctors and hospitals received nearly $59 million last year from drug companies and device makers in gifts, travel, royalties, and consulting/other fees. Of that money, doctors received more than $56 million, while forty-seven hospitals received roughly $2.8 million.

In addition to the interactive map, NJ Spotlight also dissected the payments made to physicians and arranged them in lists, by physician last name. Letters A-L and hospital payments can be found here, while letters M-Z can be found here.

Hospital Receipts

Hackensack University Medical Center was the hospital that received the most in payments - $791,980 – with almost $600,000 of that in payments from Intuitive Surgical, Inc., maker of the da Vinci robotic surgery system. That roughly $600,000 in payments were paid primarily as rental or facility fees.

Morristown Medical Center received $550,000, more than half in the form of grants, with the largest amount (almost $262,000) coming from Novartis Pharmaceuticals, a New Jersey based company.

St. Joseph Hospital and Medical Center in Paterson received $284,000, with the largest payment a $176,000 grant from Gilead Sciences, Inc.

Doctor Receipts

In addition to those hospitals, thirty-one individual doctors received more than $200,000 each. More than 23,000 New Jersey doctors, dentists, optometrists, podiatrists, chiropractors, and others received payments ranging from a few pennies to $4.4 million. That large $4.4 million payout was categorized as a dividend or return on investment, paid by Par Pharmaceutical of New York to Sharad Sunder Mansukani, a Moorestown ophthalmologist. In part because of that large payout, Mansukani received the most payments of any doctor in New Jersey ($5.1 million), mostly in dividends from Par. He also received an additional $45,000 from Par and $40,000 from Immucor, Inc., of Georgia as faculty or speaking fees.

There was only one other doctor who received over $1 million in payments – Randal Betz, an orthopedic surgeon from Lawrenceville. He received payments from a total of nine companies, including $1.4 million in royalty or licensing fees from DePuy Synthes Products, LLC. Roughly $300,000 in other payments led to a total of almost $1.7 million in total payments received.

Other Payments Made

A dozen companies made over $1 million in payments, with the biggest categories for faculty or speaking fees ($16.6 million) and consulting fees ($11.3 million). Companies also spent around $10 million on food and beverages, $4.5 million on physicians’ travel and lodging, $1.3 million in grants, $1.2 million in education, and $1 million for speaking or teaching as part of a continuing medical education program. There were also more than $5 million in investment returns and nearly $5 million in royalty or licensing fees received by doctors.

August 11, 2016

Transparency Update: Germany

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We frequently write about the transparency requirements found in the United States Physician Payments Sunshine Act and the resulting statistics; however, the United States is not the only country with recently-enacted transparency laws. Germany recently released their first transparency numbers, following a push by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.” (FSA).

In 2015, more than 575 million euros were given to physicians, specialist group members, and medical institutions from various drug companies. Spiegel, a highly-recognized German journal, compiled the data into a database. You can search the database in several different ways, including by zip code and city.

If there are several physicians at the same address that received money from industry, the tool will show the receiver with the highest total. All other recipients, and a breakdown by category, can also be found via a link in the tooltip. Doctors and institutions were asked for consent for the release of their data. If a particular physician or provider is not found in the database, it can mean he or she accepted no money or that he or she did not want his or her name released.

Shortcomings

However, as with many other transparency efforts, there were some shortcomings in Germany as well. Spiegel recognized that the quality of the data was doubtful in some cases, such as when the sums specified did not match up with the listed payments. Some addresses were also partially incomplete, making it so that individual points on the map are not always entirely accurate.

As previously noted, doctors and physicians were asked for their consent to be named in the data. Under Germany transparency requirements, a doctor will only be listed by name if they agree. Of the 71,000 doctors who received grants, only about 20,000 gave their consent to be named.

Additionally, the initiative does not cover all pharmaceutical companies, the participating companies represent about 75% of the German market for prescription drugs and the sums that individual doctors receive for studies and controversial surveillance studies is not documented.

Lastly, one major concern is that there is no central repository for information, curious patients must go to each website of the fifty-four participating pharmaceutical companies and search through for information.

Interestingly, the reporters at Spiegel turn their eyes toward the United States, noting that our Physician Payment Sunshine Act is a true transparency model that ought to be followed, where the name of the physician, the reason for the payment, and the amount of the payment are all required. Then, all the data is collected and entered into a central, publicly accessible and searchable database in which everyone can search for – and find – their physicians.

The reporters over at Spiegel request that perhaps the government should get involved and draft legislation that makes the Germany transparency effort more like the United States transparency effort. However, the Health Minister of the CDU, Hermann Grohe, notes that there is no further legislation planned on the topic in Germany.

Conclusion

Transparency has been a buzz word in the United States for quite some time now, and transparency efforts across the pond are also underway. While we are still suspicious of the benefits of transparency, we encourage our readers to stay abreast of any changes in the transparency law of your respective country.

For a more in-depth review of Germany transparency numbers, as well as United Kingdom transparency numbers, see the August 2016 issue of Life Science Compliance Update (sub req).

August 10, 2016

How Dollars for Docs Hospital Connection Was Formed

Recently, we were treated to a series of articles by ProPublica promoting the nefarious physician and hospital ties with industry. The organization behind the Dollars for Docs website, wrote an article for the Boston Globe about how the data behind the website was compiled. The article starts by listing the goal of the website, "to compare US hospitals based on the percentage of their affiliated physicians who receive payments of various sizes from pharmaceutical and medical device companies."

Gathering Data

The group turned to the federal government's Open Payments system to find information on industry payments to doctors. They used a file called "General payments," which includes categories like promotional speaking, consulting, meals, travel, gifts and royalties. This category does not include payments for research.

Next, to determine which physicians practiced at which hospitals, they used Medicare's Physician Compare data, which includes up to five hospital affiliations for each physician. The researchers then used archived Physician Compare data to obtain a snapshot of physician hospital affiliations as of December 2014. However, this data does not include doctors who do not participate in Medicare and those who do not admit may patients to the hospital. The file included records on 600,348 physicians who had at least one hospital affiliation listed.

To get information on a hospital's characteristics, including the address and ownership of the hospital, the researchers relied on Medicare's Provider of Services file from 2014 and data from the American Hospital Association Annual Survey. The analysis included just under 5,000 hospitals (4,815) and of those, 2,241 are included in the Dollars for Docs website because they had at least fifty affiliated physicians.

The last step in collecting data was accessing ratings that were assigned to select teaching hospitals in 2014 by the American Medical Student Association, known as the AMSA Scorecard. AMSA reviewed the conflict-of-interest policies of 204 teaching hospitals and graded them: A (the best grade) through C. Some teaching hospitals received an "Incomplete" because their policies were "insufficient for evaluation." ProPublica researchers obtained this information through the Internet Archive.

Combining the Data

Here is where the fun comes in: combining and cleaning out the data. ProPublica reached out to "several hospitals" to verify the accuracy of hospital affiliation of physicians. After consulting with the hospitals, they made the decision to only include each doctor's primary hospital affiliation, as well as include only the top 100 medical specialties in the Physician Compare and Open Payments data. Such a move excluded nurse practitioners and physician assistants who do not have to report industry payments, along with doctors that are not enrolled in Medicare.

ProPublica then matched the physicians in the Open Payments data (which uses a unique ID) to their National Provider Identifier (NPI) numbers. According to ProPublica, their methods were able to match more than 99.7 percent of physicians to their NPI numbers. From there, researchers matched the 2014 Physician Compare data to the 2014 Open Payments data.

For every hospital, ProPublica calculated the number of physicians who listed it as the primary affiliation in December 2014, the number of those who received a payment (and percentage), the total number of payments to doctors at that hospital, the number who received at least $100 in payments, the number who received at least $1,000 in payments, the number who received at least $5,000 in payments, and the number who were promotional speakers.

Conclusion

In conclusion, we see that ProPublica went to great lengths to try to shed light on industry payments to physicians: pulling from several related (and non-related) databases to come up with the information. While the statistical correlation is high (.93 according to ProPublica), it is hard to be certain that the database is not only reliable, but a beneficial resource for patients.

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