Life Science Compliance Update

February 06, 2017

Discussion on Open Payments by Philadelphia-Region Doctors

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An article in the Philadelphia Business Journal published in early January 2017 focused on Open Payments and payment information available to the public, and how the public availability of the data is affecting doctors and the way they treat patients.

According to the article, Dr. Stanley Schwartz is on a mission to change how physicians treat diabetic patients. The Ardmore endocrinologist, an advocate for reducing the use of insulin in diabetics in favor of other medicine regimens, placed 15th in a ranking of area physicians who received non-research payments from drug companies and medical-device makers.

"To me the Sunshine Act is, you'll excuse the expression, 'a necessary evil' that is meant to reassure people that I approach the care of my patients ethically as I go out and teach physicians across the region, across the country and across the world how to better take care of diabetes," Schwartz said. "It's a necessary evil because there is a worry money may alter my care. What I submit is maybe there are some doctors where that is true, but in my own mind I feel very comfortable telling you that for me, that's not true."

CMS, in its most recent Open Payments report, noted the total payments nationwide fell into three major categories: $2.6 billion for general non-research-related payments, which include speaking fees and food and travel; $3.89 billion for research payments; and $1.03 billion for royalties, licensing fees or ownership or investment interests held by physicians or their immediate family members.

Payments Made to Specialty Physicians

In the article, it was noted that thirteen of the twenty doctors who received the highest payments in the tri-state area were orthopedic surgeons who specialize in knee, shoulder, and spine specialties. Eight of those thirteen are part of the Philadelphia-based Rothman Institute.

Dr. Alexander Vacarro, president of the Rothman Institute, noted, "Rothman Institute is fully committed to the transparency mandated by the Sunshine Act. As national and international leaders in musculoskeletal science, several of our physicians receive compensation for their tireless dedication to basic science and clinical research in an effort to advance the field of orthopedics. Working in conjunction with industry brings this life-saving technology to not only the patients in the communities we serve, but also to people around the world. The physicians of Rothman Institute remain completely transparent in reporting income from these arrangements and will continue to do so."

According to Patricia Audet, chairwoman of the department of pharmaceutical and health care business at the University of Sciences in Philadelphia, "The issue of physician payments is important because it made people aware of payments made to potentially influence doctors. But it doesn't mean all payments are for influencing doctors."

A Doctor’s Perspective

Dr. Schwartz is a member of the speaker bureaus for several pharmaceutical companies, and he spends roughly one-third of his time teaching other doctors about the "disease state" of diabetes and two-thirds of his time discussing specific medicines that he uses as part of the treatment regimen he has developed to treat diabetics. "If there is a drug I don't believe in, I won't speak for it," he said. "I don't speak for everybody who asks. I speak for ones I believe fit into the construct of what I teach."

Schwartz notes that he "get[s] a rush" out of educating others. "When I see people's eyes light up it gives me a good feeling," he said. "The second pleasure I get is I am changing diabetes not just here, but all over the world. One month ago I spoke in Korea, next month I am speaking in Manila. I've been to China four times. … I think it's a responsibility for somebody like me to educate others, even if our process if being funded by pharmaceutical companies, because I am doing it in an ethical way. I can do it throughout the world and help millions of patients."

He makes no apologies for accepting payment from drug companies to instruct physicians. "Every time I speak to 200 doctors, each of those doctors may have 5,000 diabetic patients," he said. "I am affecting the care of [potentially] a million patients. Shouldn't I get reimbursed if I can do it ethically? I know I can do it ethically."

As an aside, with a quick visit to Dr. Schwartz’ website, one can tell he truly appreciates learning and sharing his knowledge with others. His website includes numerous publications, newsletters, and papers authored by the doctor.

Critics Discuss Flaws and Potential Fixes

One of the most vocal critics of the Sunshine Act and open payment database is the American Medical Association, which after the most recent data was released, issued a statement saying, "While we appreciate the efforts of CMS to verify the data submitted by industry, continued data errors and registration challenges during the previous two years have thwarted many physicians from participating in the review and validation process. The integrity goals of the Open Payments database will not be met as long as physician review is obstructed by a registration procedure that is confusing, time consuming, and overly burdensome."

Dr. Sharad Mansukani had one of the highest totals among physicians in the Philadelphia area, $5 million in payments. The payments were primarily dividends from Par Pharmaceuticals. Dr. Mansukani, however, seems to have appeared in the database in error. "I haven't practiced for well over 10 years," he said. "I work for the private equity firm that owned Par prior to its sale, and I was also on Par's board of directors at the time. My compensation had nothing to do with me being a physician. It was [the result] of my personal investment in the company and my role with the private equity firm and the board of directors."

Former University of Pennsylvania bioethicist Arthur Caplan, now a professor of bioethics at New York University's Langone Medical Center, believes the Sunshine Act has had its desired effect - but he advised regulators to pay even closer attention to another vehicle drug companies are using, sometimes improperly, to promote their brands. He stated that the Sunshine Act has “discouraged some of the shenanigans” we used to see in previous decades, such as “cushy dinners and excursions to balmy locations." He noted that in today’s world, medication choices are dictated less by doctors and more by pharmaceutical benefit management firms with lists of preferred medicines for treating specific medical conditions.

December 06, 2016

Money in Medicine Report

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In late November, a report was released that focused on money in medicine, and the top thirty drugs that were associated with pharmaceutical industry payments to Oregon doctors. Interestingly, the top thirty list did not include many drugs that are known to be household names. For example, the top three drugs – Bydureon, Invokana, and Toujeo – are prescribed for diabetes, a highly prevalent disease in America. Three others on the list are prescribed for multiple sclerosis, a debilitating condition that is incurable and can be hard to live with. Hysingla, an abuse-deterrent hydrocodone pill, is also high on the list.

According to the series, $2.6 billion in non-research payments were made by drug and device developers to U.S. teaching hospitals and physicians in 2015. In Oregon, 100 doctors collected $9 million in payments from industry.

This is interesting, in part because the media is always harping on the pharmaceutical industry for spending money and having “influence” on physicians. However, this article and the data show that the drugs (at least in Oregon) that are most associated with pharmaceutical industry payments tend to be drugs for diseases that are highly prevalent or diseases that are hard to beat. The author of the series also gives much time and attention to the physicians themselves, who help her (and the public) understand the benefits.

Doctors who receive the payments state that they are “being compensated for their time and expertise, or in several cases, the technology they devised to advance patient care.” They also “argue that safeguards are in place to prevent undue influence from industry, such as a prohibition on receiving royalties from your own practice or even region.”

Dr. L. Nelson Hopkins, a neurosurgeon and president of the Gates Vascular Institute at Buffalo General Medical Center, believes it is important for physicians and industry to have a good relationship, “To say that physicians shouldn’t work with industry is to say that innovation shouldn’t happen. If physicians weren’t working with industry to develop concepts and to advise industry on how it’s going in the marketplace, and working with industry to iterate the product to get better and better, then that technology would be stymied.”

Gerald Williams, Jr., both a practicing physician and the president of the American Academy of Orthopaedic Surgeons, notes that it makes sense that many of his group’s members account for a large portion of the non-research compensation because their practice areas account for almost 40 percent of the total health care spending in the United States. Williams states that many orthopedic surgeons fund their own product and equipment innovations, and that even more are asked by device makers to lend their expertise in developing new tools and approaches to delivering care.

Dr. Bryan Mehlhaff, a Springfield urologist who makes presentations about cutting-edge prostate cancer drugs, sums it up quite well, “this is very FDA regulated. A lot of my patients know I’m a speaker and that I participate on advisory boards and ask if I’ve heard anything new. A lot of them like that I’m on top of new developments and on the cutting edge of what might be possible for them.”

November 29, 2016

21st Century Cures Update - Includes Exemption for Education in Open Payments

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When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.  

The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billion for President Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s cancer “moonshot” program, and $1.6 billion for a program focused on enhanced understanding of brain-related diseases like Alzheimer’s. The bill would be paid for mostly through sales of the U.S. strategic petroleum reserve and a fund created in the 2010 health care overhaul intended to promote disease prevention and public health.

The vehicle for the new bill will be existing legislation (HR 34) related to tsunami warning systems. Since the Senate has already passed an amended version of that bill, the package could be sent from the House back to the upper chamber and acted on relatively quickly. The vote is expected to take place on Wednesday, under suspension of the rules, preventing any amendments.

House Energy and Commerce Chairman Fred Upton of Michigan and Senate Health, Education, Labor and Pensions Chairman Lamar Alexander of Tennessee, the two main sponsors of the package, touted the bill as beneficial to virtually every American family. “What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day,” the lawmakers said in a joint statement. “We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate.”

Sen. Christopher S. Murphy, D-Conn., a vocal supporter of mental health changes, on Sunday released a statement praising the package. “I'm excited Republicans and Democrats have put politics aside and reached a compromise that will allow a mental health reform bill to pass side by side with major new funding to confront the nation's opioid crisis. Both parties needed to make concessions to get this deal done, but the deal that has been struck is good for patients and families. I hope we get it done,” Murphy said.

Key Provisions of the Bill

Measures related to the FDA largely remain intact from the previous House-passed bill. The biggest change is the addition of language to help speed the development of regenerative medicine, or treatments that are designed to help regrow damaged cells or tissues. Such a provision would give the FDA the ability to put some of these treatments through what’s known as “accelerated approval,” a pathway that allows companies to conduct clinical trials on smaller populations and requires follow-up studies once the drug is on the market.

The $1 billion to curb painkiller abuse would effectively grant President Obama’s budget request from February. Included in the funding is a bid to gather support from Democrats, as well as an acknowledgement that this year’s stalled appropriations process would not be adequate for funding the opioid response envisioned by the backers of an opioid abuse package signed into law this summer.

The bill’s section on mental health would make changes to the leadership structure at the Substance Abuse and Mental Health Services Administration and establish/reauthorize grants for state and community mental health services. It would give HHS tools to enhance compliance with parity laws, which require insurers that cover mental health to offer mental health benefits that are as valuable as other medical coverage.

The most notable additions are aspects of a bill from Sen. John Cornyn (S. 2002). Those provisions would offer grants to law enforcement and the judicial system to improve their capacities to deal with mental health problems. Lawmakers wound up dropping controversial language from Cornyn’s bill that would have restored gun rights to certain individuals who had been committed for mental health treatment.

The legislation also changes policies governing electronic medical records by directing the federal government to issue a voluntary model framework on the sharing of patients' health information, and creates a grant program to help develop a reporting system that would provide the government with more information about the use and security of electronic health records.

Open Payments

Inserted into the legislation is a provision from Congressman Defazio, Burgess, and Senator Barrasso to exempt applicable manufacturers from reporting payments made for continuing medical education sessions, medical journals, or textbooks. We tend to believe that the reporting requirements stifle access to important information and have a detrimental effect on continuing medical education (CME) programming.

This represents a smart tweak to the current regulation.  Unlike the other categories under Open Payments, education represents the free exchange of ideas.

“This is about patient care — doctors need good information fast and this facilitates the process,” said John Kamp, who heads the Coalition for Healthcare Communication, a group of ad agencies and medical publishers. “I want my doctors to have information about whatever the latest science is saying.” He noted that the Food and Drug Administration is currently weighing rules for allowing companies to distribute information to physicians about unapproved uses of medicines.

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