Life Science Compliance Update

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40 posts from October 2013

October 30, 2013

Physician Payment Sunshine Act: 74 Physician Organizations Request HHS to Exempt Journal Reprints and Textbooks from Open Payments Reporting

33 physician organizations and 41 state medical societies sent a joint letter on October 28th to Department of Health and Human Services Secretary Kathleen Sibelius requesting that HHS reverse its policy (under Sunshine Act regulations) that states that journal reprints and medical textbooks are considered "transfers of value" and reportable. Certainly, this letter forwards our goal of changing the regulations to include these materials as educational materials that benefit patients.

Letter to Kathleen Sibelius

The letter firmly supports the statutory and congressional intent to exempt educational materials that benefit patients from reporting. Signers for the letter included the American Medical Association publisher of JAMA, the Massachusetts Medical Society Publisher of New England Journal of Medicine plus many others.

The letter states that "We believe the regulations in this regard are contrary to both the statute and Congressional intent and will potentially harm patient care by impeding ongoing efforts to improve the quality of care through timely medical education."

The Coalition for Healthcare Communication has been in the forefront to explain to CMS and the Administration the importance of scientific peer-reviewed publications and textbooks. The groups reminded HHS that the Food and Drug Administration issued guidance in 2009 for the distribution of reprints by manufacturer representatives as long as they were distributed separately from sales materials. The FDA noted "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."

The Coalition for Healthcare Communications and the other organizations are hoping that CMS will revise their rule to exempt reprints from reporting. 

Session in DC

In addition to the letter, The Coalition for Healthcare Communication recently held a meeting in D.C. where various stakeholders discussed their concerns about compliance with Sunshine regulations. They have been working to prevent important educational tools such as reprints and textbooks from being considered "transfers of value" (TOV), which are reportable under the final rule.

"The Sunshine Act has proven to be a big, bureaucratic snowball, and I don't think any of us expected how far it would go," said Jack Angel, Executive Director, Coalition Education Foundation, at the Sept. 24 Coalition meeting. He explained that Coalition representatives have met with the Centers for Medicare & Medicaid Services (CMS) and the Office of Management and Budget (OMB) in an attempt to roll back these provisions, but to date, they remain covered by the final rule. "We continue to work at correcting the situation," Angel said.

Adam Huftalen, Senior Manager of Federal Government Affairs for Reed Elsevier, "explained that efforts to rectify the reprint and textbook issue will hinge on making clear the value both types of these materials have to both physicians and patients. For example, he said that journal reprints help to keep clinicians informed and up to date, which allows them to provide better patient care, and that the journal peer-review process and existing FDA regulations ensure that these materials are of high quality."

Huftalen also remarked that textbooks are not consulted for routine care, but are accessed at the point of care as needed. "The sole purpose of disseminating a textbook is to convey the ideas contained therein," he said. "Though CMS is not banning speech, it is substantially burdening speech, and such burdens are subject to First Amendment constraints." Legislative language may be the only way to resolve these issues if current letter-writing efforts are not successful, he added. "There are a lot of politics involved with this issue. But we are optimistic about producing results."

"One way industry can work toward positive implementation is to increase physician awareness of the rule's provisions. Charlie Hunt, publisher of BulletinHealthcare, told the Coalition meeting attendees that recent surveys of physicians show that awareness is rising. However, there is still room for improvement. He explained that targeted awareness-raising programs increased physician awareness of the financial reporting requirements from 47 percent to 58 percent in fewer than six months."

At a Sept. 23 session of the Coalition meeting, Mike McCaughan, Senior Editor, The RPM Report, asserted that drug companies should utilize Sunshine Act transparency to strengthen relationships with physicians. "Companies should have their own Web sites to crow about their dealings and relationships," he suggested. "I would brag about everything I do to improve healthcare around the world. I would count them all and report them all," he said.

"But strengthening those relationships may be difficult due to growing tension between companies and physicians," the article noted. "To improve that situation, companies should implement some best practices for data collection, accountability, reports, and financial systems, according to Kathy Bronshtein, Chief Compliance Officer, Sudler and Hennessey."

For example, on the data collection front, she suggested that:

  • attendee sign-up sheets be used at events,
  • meals have an opt-out provision and
  • the value of the event to the HCP be made known to event recipients.

This way, she explained, "it should be clear to HCPs that they are participating and that a certain value will be reported in their name. She noted that a lack of standardization within and among companies is bound to be confusing to physicians," and that the dispute resolution process is "when all hell is going to break loose. Make sure you have the info to back up your position."

Bronshtein also encouraged industry to raise HCP awareness by ensuring that they inform HCPs about what they are signing up for, which process the company will use to report, and that they should register on the CMS Web site to view the TOV reported against their names.


October 29, 2013

Impacts of Pharmaceutical Marketing and Healthcare Services in the District of Columbia: Focus on Antipsychotics in the Elderly

In April of last year, we wrote about Washington, DC's AccessRX Act, which requires pharmaceutical companies that market products in the District to file annual reports on marketing expenditures.

In 2011, 158 pharmaceutical companies reported spending a total of $83.7 million on marketing activities in DC, including $57.9 (69.2%) million on employee and contractor expenses, $18.9 (22.5%) million on gifts and payments, and $6.9 (8.2%) million on advertising. A 2009 report addressed pharmaceutical marketing and healthcare services more broadly in DC. Additional reports were then published in for 2010 and 2011.

Hospitals, medical societies, and other nonindividual recipients received a total of $9.7 million in payments from these companies; payments to individuals totaled $9.2 million. Physicians received 81% of all payments, for a total gift value of $8.6 million (46% of the value of all reported payments).

More recently, the SafeRx Act requires the licensure of detailers (pharmaceutical sales representatives) and establishes an academic detailing program that provides unbiased drug information to prescribers.

Consequently, the DC Department of Health (DOH) recently released a report entitled, "Impacts of Pharmaceutical Marketing on Healthcare Services in the District of Columbia-Focus on Antipsychotics in the Elderly."

The report addresses the health of DC's senior population, with a focus on the use of antipsychotics, and investigates the ways that pharmaceutical marketing may affect the cost, utilization, and delivery of healthcare services in DC. Data submitted by manufacturers regarding marketing expenditures was analyzed by researchers at the George Washington University School of Public Health and Health Services (SPHHS).

In 2008, the most recent year for which data are available, the District’s Medicaid program spent $91.5 million on pharmaceuticals. The drug groups accounting for the largest expenditures were antivirals ($31 million), antipsychotics ($16 million), and anticonvulsants ($6 million).

One of the main reasons for conducting the report was in response to the "soaring rates" of off-label prescriptions for antipsychotics. The report notes that antipsychotics were prescribed off-label in 9 million visits in 2008, compared to 4.4 million visits in 1995. In 2007, 83% of antipsychotic prescriptions for the elderly were written off-label. Finally, the authors noted that while "some off-label uses are supported by scientific evidence, … in 2008, 91% of prescriptions for off-label use were backed by 'uncertain evidence.'"

In addition, The issue of excessive antipsychotic prescribing has been receiving national attention. A 2012 report by DOH focused specifically on the use of antipsychotics in children, particularly those enrolled in the District's Medicaid program. Most recently, the Office of the Inspector General (OIG) for the US Department of Health and Human Services (HHS) launched an examination of antipsychotics prescribed to Medicaidenrolled children in California, Florida, Illinois, New York, and Texas.

For those Sunshine Act stakeholders, this is the kind of report we can expect journalist organizations and other entities to publish once the Open Payments data is made public in September 2014, if the contractors hired by CMS are able to manage that deadline.

Executive Summary

Given the concerns over the use of antipsychotics in nursing homes, the authors analyzed the pharmaceutical marketing reports submitted to DC to evaluate whether nursing home medical directors appear to be "preferentially targeted for marketing efforts." The authors obtained a list of DC nursing home medical directors and searched for records of pharma-company payments to these individuals using the AccessRx database.

Importantly, the authors conducting the analysis "found no indication that pharmaceutical companies are heavily targeting their marketing efforts at District nursing home medical directors, or that those receiving drug company gifts have higher average costs for their Part D prescriptions as a whole."

The report found that the "majority of District nursing homes have antipsychotic prescribing rates below the national average." Additionally, "thirteen (13) of the District's 19 nursing homes receive above average ratings for overall quality from the Centers for Medicare and Medicaid Services' (CMS) Nursing Home Compare website.

After searching the AccessRx database (which covers 2007 through 2011) for records of pharmaceuticalcompany payments (the report calls all payments gifts) to physicians who currently serve as nursing home medical directors, the authors found:

  • About half (nine of 19) of these physicians received no payments from pharmaceutical companies between 2007 and 2011.
  • Seven (7) of the physicians received singleyear payment totals of less than $100, all in the form of food.
  • Six (6) of the physicians received payments totaling $100 $800 in at least one year. Most of these payments were in the form of food; some took the form of books.
  • Only four physicians received pharmaceuticalcompany payments totaling more than $1,000 in at least one of the years studied. Three received cash or checks for speaking or consulting, which totaled $34,639 over five years. All four of these physicians received food from pharmaceutical companies.

Of the ten medicaldirector physicians to whom pharmaceutical companies reported giving payments in 20072011, two received payments in one or two years; four received payments in three or four years; and four received payments in all five years.

The total value of reported pharmaceuticalcompany payments to District nursing home medical directors during these years "is relatively low compared to the total value of gifts to physicians who received the greatest total amounts during that time period."

The authors also stated that "no statistically significant differences in overall ratings or antipsychotic prescription rates were found between nursing homes whose medical directors received gifts between 2007 and 2011 and those who did not receive gifts."

The authors of the report also used ProPublica's online Prescriber Checkup database to examine prescription patterns by DC psychiatrists to Medicare Part D beneficiaries, the majority of whom are seniors.

Their search found 41 psychiatrists in DC (specialties are selfreported by prescribers) who prescribe antipsychotics to Medicare patients. The 44,828 claims for Part D prescriptions written by these psychiatrists had a total cost of $7.5 million and an average cost of $162.

Using the AccessRx database, the report found that 31 of 41 District psychiatrists appearing in the Prescriber Checkup database received payments from the manufacturers of six commonly prescribed antipsychotics in 2010—Clozapine, Geodon, Risperidone, Seroquel, and Zyprexa. Their giftvalue totals ranged from $89 to $52,903, with a median value of $533. Thirteen (13) psychiatrists received fewer than five payments from antipsychotic manufacturers in 2010, and nine received 10 or more. The ten psychiatrists receiving the highest total gift amounts from antipsychotic manufacturers collectively received 161 payments totaling $66,613.

As a group, the 31 psychiatrists listed in both Prescriber Checkup and the AccessRx database received 244 payments from antipsychotic manufacturers totaling $70,556 in value in 2010. While that is a large sum, it is far lower than the $446,530 these antipsychotic manufacturers gave to the ten District psychiatrists who received the largest gift amounts in 2010.

These 31 psychiatrists wrote 36,079 prescriptions that were filled by Part D beneficiaries; these claims had a total cost of $6.3 million and an average cost of $166. That compares to an average cost of $149 for the ten prescribing psychiatrists receiving no payments from antipsychotic manufacturers in 2010.

The difference in average prescription costs is not statistically significant; i.e., "this analysis does not indicate that receiving payments from antipsychotic manufacturers corresponds to higher average prescription costs for Part D prescriptions written by District psychiatrists," the authors concluded.

Most of the top prescribers of six commonly used antipsychotics in the Prescriber Checkup database were psychiatrists, including nine of ten prescribers with the highest Part D antipsychotic claims totals. The percentage of these prescribers' Part D patients receiving antipsychotics ranges from 7% to 92%.


The authors maintain that, "Pharmaceutical marketing can influence providers' decisions about which patients need drug therapies and which drugs to prescribe." Such influence can be "problematic when it results in patients taking drugs whose risks of adverse events and costs are too high relative to the benefits the patients receive," the authors maintain.

Nevertheless, the authors also acknowledge that "Prescription drugs play an important role in improving District residents' quality of life," and "can allow patients to prevent, cure, and manage health problems that could otherwise be disabling or fatal, from hypertension to HIV to mental illness."

"Many healthcare providers lack the time to keep up on medical literature for a growing list of prescription drugs, and so rely on information from pharmaceutical companies." Unfortunately, the authors only portray the potentially negative aspects of information from manufacturers, frequently citing documents from settlements and litigation. For example, the authors maintain that information from companies "may downplay or fail to disclose adverse effects or drug interactions while exaggerating the effectiveness of the company's newer products."

Additionally, without providing evidence to support their claim, they note that, "marketing efforts may also encourage offlabel use of drugs, whether or not such uses are supported by strong evidence of safety and efficacy." 

The report also raises the argument that when companies provide "free food"; samples; compensation for travel and lodging; or hire physicians as speakers or consultants, such relationships "may create a sense of obligation in prescribers." Finally, the authors point to new research that used ProPublica's Prescriber Checkup database to support their concerns about improper industry influence of physician prescribing.

The research, used a sample of 334,086 Part D prescribers, 58% of whom received at least one payment from the 12 companies. The authors found that the industrypaid physicians generated 14.7 claims per patient, compared to 13.7 claims per patient for the average doctor in the sample. How is that statistically significant? Doctors who received at least one payment submitted one (1) more claim than those that did not?

Are we really wasting hundreds of millions of dollars collecting this information and threatening physician-industry collaboration for one claim?

The research did show that "Doctors in the top 20% of those who received the payments from pharmaceutical companies prescribed twice as many branded drugs as those in the bottom 20%." It also found that "physicians who were paid by a particular firm were twice as likely to prescribe drugs made by that firm, compared with doctors who received no money from that firm."

This should not be shocking. Doctors with fewer options are more likely to prescribe brands when there are no alternatives or when generics are not a sufficient or available substitute. Moreover, doctors who are familiar with drugs because of truthful and nonmisleading information would not prescribe a medicine because of a bagel or pizza at the risk of being sued for malpractice and losing their license. These doctors analyze the information they receive knowing it comes from the manufacturer and make an informed decision based on the patients history, diagnosis and other scientific factors. To suggest that the primary factor driving these prescriptions are $10 meals is shortsighted.

In addition, this data does not analyze what kind of doctors are making these prescriptions or what diseases they were treating or curing. These facts are particularly important because primary care physicians must treat a wide array of diseases that might make it more important for them to discuss new treatments and options with manufacturers and to request information. Likewise, specialists may need to consult more regularly with manufacturers to learn about updates, modifications or changes to a device or treatment based on adverse events or post-market clinical data.

Furthermore, the background section of the 2013 DOH report is also problematic because to support their claims about improper influence into physician prescribing, the authors cite to their own previous research and reports from the DOH. Moreover, several of the authors are outspoken critics of industry and have their own conflicts of interest and lack of objectivity, making the assertions and this report problematic.

Nursing Homes and Part D Prescribers in the District

For the District's elderly, use of antipsychotics puts seniors at increased risk of serious adverse events, including extra pyramidal symptoms, cognitive decline, neuroleptic malignant syndrome, weight gain, hypothermia, hip fractures, and death. While the risk-benefit ratio may be acceptable for patients with schizophrenia or bipolar disorder, "elderly patients suffering from dementia, agitation, anxiety, or insomnia may be dosed with antipsychotics for their sedative qualities, bringing the patients few overall benefits while putting them at risk for serious adverse events." The US Department of Justice (DOJ) has taken action against drug companies for inappropriate promotion of antipsychotics to nursing homes (US DOJ, 2009; US DOJ, 2010).

In 2009, Eli Lilly reached a $1.4 billion settlement with the DOJ for its "5 at 5" campaign suggesting that 5 mg of Zyprexa at 5pm would help patients sleep (US DOJ, 2009). Research suggests that alternative treatments for dementia and agitation may improve symptoms with fewer risks.

However, the report found that the majority of District nursing homes have antipsychotic prescribing rates below the national averages. In the US as a whole, 2.7% of shortstay nursing home residents receive new antipsychotic prescriptions and 22.4% of longstay nursing home residents receive an antipsychotic medication (CMS Nursing Home Compare, 2013).

In the District, seven out of 18 nursing homes have aboveaverage prescribing rates for shortstay patients, and six out of 19 have aboveaverage rates of longstay patients taking antipsychotics.

Ultimately, the report concluded by noting that while prescription drugs play "an important role in the health of the District's seniors, inappropriate use of antipsychotics for seniors brings an increased risk of serious adverse events, including death, without a commensurate benefit." Nevertheless, their "analysis of pharmaceutical marketing data did not find evidence of extensive marketing targeted at nursing home medical directors."

The authors emphasized the important role and value that "publicly accessible databases such as Nursing Home Compare and Prescriber Checkup, combined with the AccessRx pharmaceutical marketing database, can play. Researchers, payers, healthcare providers, and individuals choosing doctors or nursing homes can all benefit from the information they contain."

They recommend making AccessRx data available to the public to "complement and advance this beneficial transparency."

Physician Payment Sunshine Act: Radiologists Concerned With Potential Mischaracterizations of Relationships With Industry

A recent article from discussed what diagnostic radiologists "need to know" about the Physician Payment Sunshine Act. The article pointed out a previous survey, which showed that more than half of physicians do not know about the Sunshine Act or that certain payments made to physicians by applicable manufacturers will be made public. This survey "echoes" the experience of Nogah Haramati, MD.

"The vast majority of individuals with whom I've discussed this act have never heard of it," said the professor of clinical radiology at Albert Einstein College of Medicine, who wrote about the Sunshine Act for the June 2013 issue of the Journal of the American College of Radiology.

Radiologists need to care because the Sunshine reports may not paint an accurate picture. For example, a manufacturer may report a $50,000 grant in the travel or the research category, leading to misperception issues. "It may look like the physician went on great junkets to the South Pacific, whereas it was used to send 12 graduate students to a conference in Detroit," Haramati said.

The law requires that vendors report transfers of value to physicians and teaching hospitals, but it does not include reporting gains by individual medical students and PhD researchers, Haramati added.

"Even if it appears as $200,000 for research, it's difficult to explain when a patient says 'you're getting fat on it,' and I say 'but I really run this lab,'" he said. "That database can introduce a credibility problem into the equation, which may be the lawmakers' intent."

"The difficult cases will be those in which [a physician is] doing nothing improper and the relationship is entirely legitimate, yet it can give the appearance of some type of undue influence on your practice of medicine," said Craig B. Garner, JD, an attorney in Santa Monica, Calif. "Those cases will require you to assess how much that income means to you. There's not always something wrong with doing work for these companies, but there is such a stigma these days that any nexus can be negative," Garner told Health Leaders Media.

While physicians can appeal to the manufacturer if they believe the reported information is incorrect, "they're under no obligation to change anything," Haramati said, adding that the government penalties for manufacturer noncompliance are steep. A physician can request that a manufacturer re-categorize a payment, but the manufacturer "will defer to their legal advisors and take what they deem to be the safest route. The relationship with the physician is one thing. Draconian financial penalties are another. It's hard to argue with the government."

Lavish dinners, trips, and gifts to physicians dried up years back, and institutions like Haramati's already have a restrictive manufacturer policy, the article notes. "Physicians can be fired for receiving anything of value from a vendor." To be on the safe side, "Haramati tells colleagues and staff it's best to avoid attending manufacturer-sponsored events since a portion of the event cost may be attributed to each physician attending."

Haramati requires manufacturers "to provide a written guarantee that he receives no value from and won't appear in the database for any activity or conference call he participates in. If the manufacturer can't provide a guarantee, he pulls out." "I don't want to appear in the database," he said.

Unfortunately, this is the exact kind of negative effect and stigma we have been concerned with from the very beginning—that the Sunshine Act would discourage physicians from collaborating with industry to develop new treatments, conduct research, educate their peers, and even receive new clinical data and information to improve their knowledge, competency and patient care.

"A physician concerned about looking bad in the database should take proactive measures to be transparent and up front with patients, said Bob Still, practice administrator at MRI Group in Lancaster, Penn. He recommends that practices participating in clinical trials or working with vendors on new and emerging equipment state this on their websites, since using cutting edge equipment can benefit the patients."

"I don't think there's anything wrong with a practice saying they receive remuneration to do this kind of research," Still said.

With respect to the burden of Sunshine reporting, Still noted that most of the tasks will fall on industry and various staff members of a physicians practice. Still recommended that practices review payments quarterly and that physicians take some responsibility for overseeing compliance if they choose to have relationships with industry.

For those physicians not involved with manufacturers, there may be little to report. "General diagnostic radiologists have less contact with manufacturers than interventional radiologists who buy a lot of devices, Still said." Hospital-based physicians probably also have less exposure because the institution is buying the equipment, though the radiology group may participate in purchases as advisors.

"Imaging center owners have to be more aware of the Sunshine Act, he said, cognizant of ramifications of interactions with the sales people."

Physicians, like Haramati, want to stay out of the database completely, but since industry is so intertwined with medicine – and since physicians don't have ultimate control – he's unsure whether that's feasible.

"Will I succeed? It's very hard to tell," Haramati said, noting that he recently lectured at an academic meeting organized by a skeletal radiology professional society in India.

While the meeting was sponsored by several vendors, the professional society paid for his economy travel arrangements. "I was very careful," he said. "I received nothing from any vendor. However, am I aware of all vendor funding of the meeting? Will any vendor ascribe a part of the costs to me? I don't know."

Ultimately, the Sunshine Act "will have a profound effect on the relationship between physicians and the rest of the healthcare industry," says Robert Hitchcock, MD, FACEP, a practicing physician and vice president and chief medical informatics officer with T-System, a nationwide company based in Dallas that helps physicians improve efficiency and maximize revenue. This is particularly true given that physicians have limited ability to challenge or dispute a payment or its description once the company posts it.

"What this means for most physicians is that they will seriously rethink any collaboration they might have with drug companies," Hitchcock says. "As a practicing physician, I really don't want my name on a list for having been to this CME and gotten this amount of money from Pfizer and this amount from Schering-Plough. I know that I personally will no longer be attending CME that is sponsored like that."

Morever, even when attending professional meetings that are not sponsored by drug companies, Hitchcock says he will have to be careful about the social functions he attends. Breakfasts and social hours often are sponsored by drug companies, and Hitchcock says he will no longer attend those because his name would show up on the disclosure lists.

"I think once physicians see this happening, it's going to have a really chilling effect on their relationships with the healthcare industry," he says. "A lot of what is going to be disclosed is just a normal part of doing business, but I'm not sure I want my ownership value in a GPO, for instance, to be put out there for public consumption. It's like putting my taxes out there for anyone who wants to see."

Physicians must reexamine their relationships with drug and device makers, Hitchcock advises. More than ever before, he says, watch for the line between an informative interaction and the exchange of something that has monetary value. Talking with a drug company representative and accepting samples for your patients should be no problem, he says.

"Try to avoid, at all costs, accepting anything of monetary value," he says. "That will keep your name off the lists."

As a result, while most patients will not be concerned with whether physician shave a financial relationships with manufacturers, physicians should be prepared in those "few cases" to explain such relationships and "why it does not affect their clinical decision-making" said David Schweighoefer, JD, a partner with the law firm of Walter Haverfield in Cleveland. "I have spoken with some physician clients who intend to explain that relationship, however innocuous, to the patient up front so that there is no misunderstanding later."


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