Doctor-pharma ties

Doctor-pharma ties defended on eve of pay reporting mandate

■ Major stakeholders outline principles of physician-industry collaborations amid concern that all payments will be painted with a broad brush.

By KEVIN B. O’REILLY amednews staff — Posted March 25, 2013

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With the start of federally required tracking of industry payments to physicians to begin in August, some of the biggest names in medicine are staking a claim that shining a light on the financial ties between health industry companies and physicians should not discourage relationships that yield beneficial innovations in patient care.

In a statement of principles released March 11, a wide range of trade groups for pharmaceutical companies, device manufacturers, clinical research organizations and medical schools joined with physician organizations representing osteopathic doctors, neurosurgeons and other medical specialties to defend the value of research projects and other relationships among doctors and health industry companies.

“If this whole issue of physician-industry collaboration is not handled in the appropriate way, it could inhibit innovation,” said Mary R. Grealy, president of the Healthcare Leadership Council, a Washington-based nonprofit group. Its members are the chief executives at major players in health care such as AstraZeneca, Ascension Health Alliance, Cleveland Clinic Foundation, Eli Lilly & Co. and Walgreen Co. The council convened a 2010 summit and subsequent meetings that led to the statement.

The coalition outlined a framework to guide interactions between industry and physicians that seeks to protect doctors’ autonomy in providing care, to give patients and others access to “meaningful information” about collaborations, to use training and communication to assure compliance with professional codes of conduct, and to focus on the benefit of such interactions for patients.

“One of the reasons we’re developing these principles and working with this diverse group is that, as we begin to report and go public with the exchanges of value between industry and physicians — if it’s not done in a way that has some context — it might have a chilling effect on having those collaborations,” Grealy said.

The Centers for Medicare & Medicaid Services issued the final rule to implement the Physician Payments Sunshine Act in February. Starting in August, pharmaceutical companies and device manufacturers must begin tracking physician payments and gifts worth as little as $10. Public disclosure of these so-called transfers of value in a searchable federal government database starts Sept. 30, 2014.

The American Medical Association was not involved in the Healthcare Leadership Council’s statement of principles on physician-industry collaboration. The Association is developing tools to help doctors understand the Sunshine Act and talk with patients about their listings. Resources are available on an AMA website (link).

“Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients,” said AMA President Jeremy A. Lazarus, MD. “Many interactions between physicians and the pharmaceutical and medical device industries occur to advance clinical research that is essential to ensure the discovery of treatments and improve patient care. The new Physician Payments Sunshine Act is not meant to stifle these important interactions.”

Disclosure’s impact unclear

Experts see little certainty about the law’s likely effect on research, industry-sponsored physician lectures, meals provided by drug reps and other types of interaction by pharma with doctors.

Already, about 25% of physician practices refuse to see drug reps, according to an ongoing survey of hundreds of thousands of U.S. clinics by SK&A, a prescriber-profiling firm. A majority of U.S. medical schools now prohibit all gifts and on-site meals paid for by pharmaceutical companies and device manufacturers. Yet a study in the Feb. 27 issue of the Journal of General Internal Medicine found that 57% of fourth-year medical students and 54% of residents got gifts such as meals.

Among practicing physicians, more than half say they are unaware that the Sunshine Act will require industry companies to report transfers of value to doctors annually. That is according to a survey of more than 1,000 physicians released in February by the health technology company MMIS. The money that drug- and device-makers spend on in-office meals will be reported publicly if the amount spent on an individual doctor exceeds $100 over a year.

25% of physician practices refuse to see pharmaceutical manufacturing representatives.

In March, the nonprofit news outlet ProPublica updated its database of pharmaceutical company payments to doctors, which is drawn from disclosures by 15 drugmakers who account for nearly half of the market. Between 2009 and 2012, the companies paid nearly $2 billion to doctors for speaking, consulting, travel, meals, as educational items or gifts, and in royalties or license fees. Payments for speaking services declined, but industrywide trends were hard to determine. Pharma spending seemed to fluctuate over time with an individual company’s product line, research strategy and marketing plans, said Charles Ornstein, who directs the ProPublica database project.

How physician-payment disclosure legislation may translate into clinical practice also remains opaque. Two states that enacted physician payment-disclosure legislation in 2004 — Maine and West Virginia — saw no substantial shift from brand-name drugs for two classes of medications for which there are highly substitutable generic alternatives, according to a May 28, 2012, study in JAMA Internal Medicine, formerlyArchives of Internal Medicine.

Relationship already cooling

There is more evidence to indicate that, pre-Sunshine Act, doctors were interacting less with industry. Between 2004 and 2009, there was a drop in doctors’ relationships with pharmaceutical companies, according to a Nov. 8, 2010, study in JAMA Internal Medicine. The percentage of doctors who accepted food or drinks at the office fell from 83% to 72%, while those engaged in consulting arrangements dropped from 18% to 7%.

Service on company advisory boards and speakers bureaus also fell. It is unclear whether that pattern, driven largely by changing professional norms within medicine, will continue when the first Sunshine Act reports go public, said Eric G. Campbell, PhD, the study’s lead author.

“So much will depend on how it’s reported and what people can tell when they look at the data,” said Campbell, professor of medicine at Harvard Medical School in Boston. “There are certainly many physicians who would have no problem providing cogent, reasonable reasons why they engage in this activity. And not all of these relationships are marketing. Some are about research and developing new products or services, and we want doctors to talk with drug companies about this stuff.”

Daniel Carlat, MD, said the concern that payment disclosure will discourage physician collaborations with industry in research and development is overblown.

“I doubt that we’re going to see a chilling effect on those activities most important for advancing medical science,” said Dr. Carlat, director of the Pew Charitable Trusts’ Prescription Project. “We’ve had some companies disclosing payments since 2009, and we haven’t seen research grinding to a halt due to that.”

In the Sunshine era, he added, physicians will think twice about their interactions with drugmakers and other health industry firms. Such circumspection should be welcomed as a positive development, Dr. Carlat said.

Questions about physicians’ payment listings are unlikely to come from their patients, said Robert Harbaugh, MD, treasurer of the American Assn. of Neurological Surgeons, which endorsed the Healthcare Leadership Council statement of principles. He said the likelihood of patients asking about a Sunshine listing is “vanishingly small.”

Dr. Harbaugh offered this advice for doctors in this new era of transparency: “You shouldn’t be doing something that you wouldn’t be proud to see on the front page of the newspaper.”



4 principles on doctor-industry interactions

Medical industry payments and gifts to physicians will be made public starting Sept. 30, 2014. A coalition of drugmakers, device manufacturers, medical centers and physician organizations has outlined the principles it believes should guide financial relationships among doctors and industry.

  • The benefit of patients: Collaborations at any level, from the research lab to the doctor’s office, must aim to benefit patients and put patients’ interests first.
  • The autonomy of health care professionals: Health care professionals and scientists must be free to independently assess multiple sources of information and treat each patient in a manner consistent with the patient’s needs and best medical practice. This is vital to preserve the public’s trust in the innovation process and in our health care system.
  • Transparency: Patients, and all those involved in health care, should have reasonable access to relevant and meaningful information about how academic institutions, researchers, health care professionals and medical products companies engage in collaborative relationships. Transparency builds trust between patients and the health care professionals who serve them.
  • Accountability: All participants across health care must be responsible for their actions. External regulation is important here, but self-regulation with recurrent training and communication is essential to this effort.

Source: “A Joint Statement on 21st Century Collaboration for Healthcare Advancement,” National Dialogue for Healthcare Innovation, March 11 (link)



“Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests,” Federal Register, Feb. 8 (link)

American Medical Association resources on the Sunshine Act (link)

“Changing Interactions Between Physician Trainees and the Pharmaceutical Industry: A National Survey,” Journal of General Internal Medicine, published online Feb. 27 (link)

“Effect of Physician Payment Disclosure Laws on Prescribing,” JAMA Internal Medicine, formerly Archives of Internal Medicine, May 28, 2012 (link)

“Physician Professionalism and Changes in Physician-Industry Relationships From 2004 to 2009,” JAMA Internal Medicine, formerly Archives of Internal Medicine, Nov. 8, 2010 (link)

“A Joint Statement on 21st Century Collaboration for Healthcare Advancement,” National Dialogue for Healthcare Innovation, March 11 (link)

Pharma gift bans for budding doctors have long-term impact

■ Medical school and residency rules on industry-provided meals and other perks appear to influence prescribing once physicians are in practice.

By KEVIN B. O’REILLY amednews staff — Posted Feb. 18, 2013

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The gift restrictions adopted in medical schools and residency programs are linked to less prescribing of brand-name drugs, said two recently published studies that appear to be the first attempts to gauge the clinical practice impact of efforts within medicine to rein in pharma’s influence.

One study, published Jan. 31 in the British medical journal BMJ, examined the effect of bans on gifts from pharmaceutical companies and device-makers at 14 U.S. medical schools by analyzing the drug orders of about 2,500 doctors. Researchers compared the prescribing practices of physicians trained at those schools after they banned gifts in 2004 with those trained at the same schools before the bans, as well as with a matched set of doctors who attended medical schools that allowed gifts such as industry-funded meals.

They then looked at how these doctors — 46% general internists, 23% pediatricians, 10% psychiatrists and the remainder practicing other specialties — responded to three new drugs that were marketed in 2008 and 2009.

The physicians who attended no-gift med schools were 56% less likely than the other doctors to prescribe Shire’s Vyvanse (lisdexamfetamine), a stimulant used to treat attention-deficit/hyperactivity disorder. They also were 75% less likely to order Janssen’s Invega (paliperidone), an antipsychotic. For a third medicine, Pfizer’s antidepressant Pristiq (desvenlafaxine), there was no statistically significant difference in prescribing.

Researchers attributed that to a low level of overall prescribing of the drug that made it difficult to find substantial disparities between doctors who attended no-gift schools and those who did not.

The lead author of the BMJ study, Joseph S. Ross, MD, said the study verifies his personal experience. He completed his first two years at a medical school that allowed gifts from drugmakers. He then transferred, for personal reasons, to another school that had a gift ban.

“I did my last two years at Albert Einstein College of Medicine in the Bronx in 2000 and 2001. They didn’t allow drug reps. I think you recognize that in the culture when you’re attending a school, when reps are around. It’s part of the environment and part of the school and the educational setting. I think we’re seeing that effect once these students hit the market as independent prescribers,” said Dr. Ross, assistant professor of medicine at Yale University School of Medicine in Connecticut.

Effect found in residency programs

Another study in the February issue of Medical Care looked at the prescribing habits of nearly 1,700 psychiatrists. About half graduated from residency programs in 2001 before gift bans were in vogue, and the other half completed their training in 2008, after many programs banned gifts from industry as part of following the Assn. of American Medical Colleges’ conflict-of-interest guidelines.

The 2008 graduates were less likely than their 2001 counterparts to prescribe heavily promoted, brand-name antidepressants, the study found. The prescribing gap ranged from 3.6 percentage points to 6.2 percentage points, with stricter residency program rules of conflicts being tied to lower prescribing of the brand-name drugs.

“Contact with the pharmaceutical industry may have important informational benefits for physicians,” said Andrew J. Epstein, PhD, lead author of the study and research associate professor of medicine at the Perelman School of Medicine at the University of Pennsylvania. “Nevertheless, while these relationships may be useful in some ways, our study clearly shows that implementation of COI policies have helped shield physicians from the often persuasive aspects of pharmaceutical promotion.”

Proponents of stronger conflict-of-interest rules at medical schools and residency programs welcomed the findings. Since 2008, the American Medical Student Assn. has issued its PharmFree Scorecard, grading medical schools on policies such as whether they allow gifts, let drug reps visit campus without appointments, and scrutinize faculty speaking and consulting agreements with industry. Its March 2012 report found that two-thirds of schools earned an A or B grade, compared with 30% in 2009.

“These studies have shown that strong conflict-of-interest action has an effect on prescribing changes,” said Reshma Ramachandran, a fourth-year medical student at Warren Alpert School of Medicine at Brown University in Rhode Island, who is doing a fellowship on pharmaceutical policy at AMSA. “This is what we’d hoped for — that the AMSA PharmFree Scorecard would have not only an effect on institutions’ policies but also a cultural effect on students later on in practice when they are deciding what treatments to give to their patients.”

Further research should be done to evaluate the effectiveness of policies restricting interactions with industry, said Daniel J. Carlat, MD, director of the Pew Prescription Project and a supporter of such policies.

“It’s crucial that we begin to move from having strong opinions about conflicts of interest to having good data to support the value of conflict-of-interest policies,” said Dr. Carlat, a psychiatrist.

The findings come as physicians work to digest the final rule implementing the Physician Payments Sunshine Act, adopted as part of the Affordable Care Act in 2010. The Centers for Medicare & Medicaid Services estimates that it will cost physician practices and teaching hospitals staff time worth $59 million to review drugmakers’ reports of payments and gifts for accuracy.

Reports of “transfers of value” worth $10 or more to an individual doctor must be tracked, and any doctor who receives $100 or more in a year will see that information publicly reported on a searchable government website starting Sept. 30, 2014. Physicians will have 60 days to review industry reports for accuracy before they are made public.



More medical schools ban pharma gifts

Physicians trained at institutions with bans on gifts from industry are less likely to prescribe new brand-name drugs, research shows. A majority of U.S. allopathic and osteopathic medical schools now prohibit all gifts and on-site meals funded by drugmakers and device manufacturers.

Year Schools with gift bans
2011-12 53%
2010 43%
2009 29%
2008 13%

“AMSA PharmFree Scorecard 2011-2012 Executive Summary,” American Medical Student Assn., March 7, 2012 (link)



“Does Exposure to Conflict of Interest Policies in Psychiatry Residency Affect Antidepressant Prescribing?” Medical Care, Feburary (link)

“Medical school gift restriction policies and physician prescribing of newly marketed psychotropic medications: difference-in-differences analysis,” BMJ, Jan. 31 (link)

“AMSA PharmFree Scorecard 2011-2012 Executive Summary,” American Medical Student Assn., March 7, 2012 (link)

Public can see pharma payments to doctors starting in 2014

■ Revisions in the final transparency rule will give physicians more time to resolve payment amounts and won’t require disclosure of indirect pay from accredited education programs.

By CHARLES FIEGL amednews staff — Posted Feb. 11, 2013

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Washington After numerous missed deadlines, new regulations require that data on the payments and gifts that drug and medical device companies make to physicians will become available publicly in a searchable database beginning in September 2014.

The long-awaited final rule for the implementation of the Physician Payment Sunshine Act — a 2010 law requiring financial ties between manufacturers and medicine to be disclosed — was released on Feb. 1. The Centers for Medicare & Medicaid Services addressed several issues pertaining to the reporting of fees, meals, travel expenses and other transfers of value. Those issues were raised by the American Medical Association and other organized medicine groups over an earlier proposed version of the rule. For instance, CMS will allow doctors additional time to resolve disputes over any inaccurate data and will not require certain indirect payments from continued medical education programs to be reported on the database.

Under the law, manufacturers already should have started collecting information about the payments and gifts they make to physicians. The Affordable Care Act mandated that data collection for transparency reports was to start in 2012, but the Obama administration delayed finalizing regulations for more than a year as stakeholders debated aspects of the program.

Data collection now will begin on Aug. 1 for applicable manufacturers. Companies will be required to collect data from August through December during the first year, 2013. The data will be sent to CMS by March 31, 2014, and become available to the public on Sept. 30, 2014.

Manufacturers are not required to track buffet meals, snacks or cups of coffee they provide to physicians, but the value of other meals must be recorded. Transfers of value under $10 also do not need to be reported unless the cumulative amount to an individual doctor totals $100 or more in a calendar year.

Fines up to $100,000 possible

CMS can levy $10,000 fines on manufacturers for failing to report gifts. The penalty climbs to $100,000 when a manufacturer is found to have knowingly omitted payment information.

“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, MD, CMS deputy administrator for program integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

The AMA supported the concept of the Sunshine Act and will review the final regulation carefully to determine if its earlier concerns about the details of the program have been addressed, said AMA President Jeremy A. Lazarus, MD.

“Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients,” Dr. Lazarus said. “Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies. As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process.”

Organized medicine groups, manufacturers and CMS will need to increase efforts to educate physicians about the details of the Sunshine Act, said Michaeline Daboul, president and CEO of MMIS, a health technology company that develops health information exchanges. An MMIS survey of 1,000 physicians found that about half were not aware of the transparency report program. Many also were concerned about the accuracy of data gathered by companies. The survey said 43% of respondents indicated that the program would affect their relationships with drug and device firms.

Daboul suggested that physicians work directly with the companies to see their financial relationship data before the information is sent to the government. Doctors and companies need to be proactive and prepared to work together to prevent any misinformation from making its way into the public database, she said.

“If I’m a physician, I want to protect my reputation,” she said. “I want my patients to understand my relationships with industry.”

Concessions in the final rule

In the draft version of the rule, CMS had proposed a 45-day period in which physicians could review and correct their individual payment and gift data compiled by drug and device companies. The AMA had recommended that data be corrected on an ongoing basis. Other commenters called for an additional 60 to 90 days to resolve disputes after the 45-day review period.

Extended or rolling periods to address objections raised by physicians are not feasible, CMS stated in the final rule. However, the agency did agree that a distinct period should be available in which to resolve incorrect data after the 45-day window. Manufacturers and other organizations will have 15 days to correct any erroneous information following the review period, CMS said. The agency is developing a secure website for data submission, review and correction.

Organized medicine groups and others also had recommended that accredited or certified continuing medical education payments to speakers should not be reported on the database. Existing safeguards and standards regarding such compensation are in place, the groups said, and public reporting of payments or transfers of value related to educational activities would harm such programs. That reporting would lead to decreased funding for education and a falloff in attendance, they said. Furthermore, Congress did not intend for those payments to be included in transparency reports.

CMS agreed that an indirect payment made by a drug or device company to a speaker at a continuing education program does not need to be reported under certain conditions. First, the program must meet accreditation or certification standards of the AMA, the American Osteopathic Assn., the American Academy of Family Physicians, the Accreditation Council for Continuing Medical Education or the American Dental Assn. Continuing Education Recognition Program. The manufacturer cannot select the speaker or provide a third-party vendor with a list of experts for consideration to speak. Finally, the manufacturer must not pay the speaker directly.

“We believe that when applicable manufacturers suggest speakers, they are directing or targeting their funding to the speakers, so these payments will be considered indirect payments for purposes of this rule,” CMS stated. “Conversely, when they do not suggest speakers, they are allowing the continuing education provider full discretion over the [education] programming, so the payment or other transfer of value will not be considered an indirect payment for purposes of these reporting requirements.”

Murray Kopelow, MD, president and CEO of the Accreditation Council for Continuing Medical Education, applauded CMS for recognizing the value of continuing education and for agreeing that current accrediting standards are sufficient. “The standards are designed to ensure that accredited CME activities are independent, free of commercial bias, based on valid content, and contribute to health care improvement,” he said.

Unaccredited and noncertified education program payments must be reported, CMS added.

Rule stands firm in some areas

CMS disagreed with arguments that all indirect payments or other indirect transfers of value should be excluded from reporting requirements. This type of transaction occurs when a manufacturer requires, instructs or directs payment to a particular recipient regardless of whether the company specified that physician.

For example, a drug manufacturer might make a general payment to a clinic for a physician to review materials without stating the name of the physician. Because the company had directed the payment to be provided to a physician, it would be a reportable indirect payment under the final rule.

Indirect payments can be excluded from reporting requirements when manufacturers do not know the identity of the recipient. This may occur, for example, when a device manufacturer hires a research firm to conduct a double-blind market research study that pays physicians to respond to a survey.

If the exception did not apply in such a case, a manufacturer might feel obligated to track down the identity of the recipients, the rule stated. CMS’ intention is to prevent companies from directing payments to recipients whose identities can be obtained easily.

“We agree that applicable manufacturers should not be responsible for tracking and reporting indirect payments or other transfers of value indefinitely,” CMS said. At the same time, if a company determines the identity of a recipient, it is obligated to report it. Recipients discovered on or before June 30 of the year after a payment made by a third party are required to be reported on the database.



How much will sunshine reviews cost practices?

Estimates indicate that less than half of physicians, or about 449,000, have financial relationships with pharmaceutical or device manufacturers that will need to be reported publicly under the Sunshine Act. The Centers for Medicare & Medicaid Services projects that half of those physicians and their staffs actually will review their reports compiled by the companies before publication of the first year of data — causing a total administrative burden to doctors valued at roughly $59 million.

Type of reviewer Number reviewing Hours of review Average cost Total cost
Physician 224,425 1 $137 $30.7 million
Physician staff 224,425 5 $109 $24.4 million
Teaching hospital compliance officer 1,100 40 $1,752 $1.9 million
Teaching hospital staff 1,100 80 $1,726 $1.9 million

Source: “Medicare, Medicaid, Children’s Health Insurance Programs: Transparency Reports and Reporting of Physician Ownership or Investment Interests,” Federal Register, Feb. 8 (link)


Copyright © 2013 American Medical Association. All rights reserved.
  • » Doctor-pharma ties defended on eve of pay reporting mandate March 25
  • » Pharma gift bans for budding doctors have long-term impact Feb. 18
  • » Physicians, industry continue to wait for Sunshine Act rules Sept. 20
  • » Organized medicine seeks more latitude to challenge industry gift reports March 12
  • » CMS proposes sunshine rules on industry payments, gifts to doctors Dec. 26
  • Physicians, industry continue to wait for Sunshine Act rules

    ■ Senators renew their calls on the administration to meet statutory deadlines for a program that will disclose payments to doctors from drug and device companies.

    By CHARLES FIEGL amednews staff — Posted Sept. 20, 2012

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    Washington Senators from both major parties sharply criticized the Centers for Medicare & Medicaid Services for the continued delay in regulations on publicizing the financial ties between physicians and pharmaceutical, medical device and biologics companies during a Sept. 12 hearing.

    The Senate Special Committee on Aging convened a roundtable discussion on the long-awaited implementation of the Sunshine Act, a bipartisan component to the 2010 health system reform law. Senators took the opportunity to voice their frustration with the agency tasked with running a program that is designed to allow public searches of databases to find information about individual physicians’ financial relationships.

    CMS published a proposed rule for the Sunshine Act on Dec. 14, 2011, more than two months after the rule was supposed to be finalized. The overdue rule now should be ready following a review and comment period during the past nine months, said Sen. Charles Grassley (R, Iowa). However, the regulation still is in a state of flux. The rule is rumored to be awaiting final approval by the White House Office of Management and Budget, and probably will not be finalized until after Election Day, Grassley said.

    “Our efforts to engage with CMS on the implementation of the Sunshine Act have been met with resistance and silence — just [as if] Congress passing a law doesn’t make any difference in this town,” he said.

    The delay is unacceptable, agreed Senate Special Committee on Aging Chair Herb Kohl (D, Wis.). The public has the right to know about payments and gifts from the health care industry to doctors, and the law is not overly burdensome, because several drug manufacturers already release such information through disclosures on their own websites, he said.

    CMS received more than 300 comments on the proposed rule. The agency has continued to assess the requirements for the program to ensure that it can accurately and effectively collect and publish the data, said Niall Brennan, director of the CMS policy and data analysis group.

    “While there were a lot of comments, some [issues] were certainly commented on more often than others: continuing education, the treatment of indirect research payments, and the process for resolving disputes between physicians and manufacturers,” Brennan said.

    The agency has announced that it will not require manufacturers to begin collecting disclosure data before Jan. 1, 2013. Brennan said during the hearing that manufacturers probably will be required to begin data collection later in 2013.

    The American Medical Association supports the effort to increase transparency but wants physicians to be able to review their information and lodge a challenge before publication if they find any of it erroneous. The final regulations should ensure that the process will provide necessary insight on physician-industry relationships without being burdensome for those involved, said AMA President Jeremy A. Lazarus, MD.

    “It is important to note, however, that while not all transfers are subject to reporting under the Sunshine Act, the AMA provides ethical guidance that covers all transfers, including indirect ones,” Dr. Lazarus said.

    Organized medicine seeks more latitude to challenge industry gift reports

    ■ Physician organizations say doctors must be given more time to correct public information about what they have received from drug and device makers.

    By CHARLES FIEGL amednews staff — Posted March 12, 2012

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    Washington — Proposed rules requiring transparency reports on what physicians receive from drugmakers and medical device manufacturers would impose costly burdens on practices and could lead to the publication of misleading information to the public, according to physicians and health industry organizations.

    The American Medical Association and more than 90 specialty and state medical societies urged the Centers for Medicare & Medicaid Services to make several changes to its proposed rule implementing the Sunshine Act, a provision included in the 2010 health system reform law. In a Feb. 17 letter to CMS, the organizations stated that they supported the underlying goal of enhancing transparency but said the rule needs numerous revisions.

    The Sunshine Act requires drug and device manufacturers to track gifts and payments to physicians and teaching hospitals starting in 2012. Any transfers of value of more than $10 — as well as any smaller individual payments to doctors whose total transfers exceed $100 — would be made available on a searchable website beginning in 2013.

    The reform law gives physicians the right to challenge reports after their publication. However, organized medicine said Congress did not intend for those disputes to be resolved only during a 45-day period once a year, as proposed by CMS.

    “We oppose limiting a physician’s ability to challenge the accuracy of reports to the ‘current’ and prior reporting year within a compressed 45-day window each year,” the letter states. “There is no statutory support for this provision, and it is inconsistent with the Congress’ intent to ensure such reports are accurate.”

    CMS instead should allow physicians and manufacturers to make any needed corrections on an ongoing basis, the physician organizations said.

    Trade groups agreed that 45 days would not be enough time for the corrections process. Pharmaceutical Research and Manufacturers of America said in its comments on the proposed rule that drug companies have no way of knowing how many doctors and others would dispute data during the first year. PhRMA recommended an initial review period of 45 days and another 45-day period to adjudicate disputes.

    CMS also included indirect transfers to physicians as reportable events in the proposed rule. However, the organized medicine groups said the inclusion of such transfers was not authorized by Congress and exceeds the limits of the statute.

    The physicians argued, for example, that payments by a certified continuing medical education provider to a physician should not be reportable under the law. Grants from manufacturers for CME programs already are regulated, and companies are prohibited from having influence over how funds are used, such as through the selection of faculty.

    Medtronic, the medical device manufacturer, called for other changes that it said would make data reporting more accurate and meaningful for patients. Medtronic already has experience disclosing such information. In 2010, it began posting financial relationships with physicians that meet a minimum threshold of $5,000.

    CMS should provide more context to help the public understand the information, the manufacturer said. For instance, the Food and Drug Administration requires clinical trials before the agency will permit a new device to enter the marketplace. Such trials can last years, involve many entities and end up being very costly.

    “Simply posting the total dollars paid for consulting and research arrangements, for example, does not tell the whole story and, therefore, provides little value to the public,” said Thomas J. Schumacher, Medtronic chief ethics and compliance officer, in a Feb. 17 letter. “In some ways, it is very misleading.”

    The drug manufacturer Merck & Co. took issue with several aspects of the proposed regulation that it said needed at least further clarification. The methodology for calculating the allocation of meals during group settings, for instance, would lead to inaccurate data, Merck said. The manufacturer would be required to report the cost per covered recipient regardless of whether noncovered individuals, such as office staff, had meals or if a physician attended a session but declined to eat.

    The drugmaker suggested that manufacturers be required to report only on a physician who partakes in a meal and then to attribute a value for what he or she ate.


    Ban on pharma meals for physicians overturned

    ■ Massachusetts, the first state to ban all gifts from industry, says “modest” food and drinks are OK.

    By KEVIN B. O’REILLY amednews staff — Posted July 23, 2012

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    Massachusetts has repealed a 2008 state ban on industry-provided meals for physicians and other health professionals.

    The change allows medical industry companies to pay for “modest meals and refreshments” for doctors and other health professionals in connection with educational presentations that are not certified by the Accreditation Council for Continuing Medical Education. The presentations must happen “in a venue and manner conducive to informational communication,” the new law says.

    Restaurateurs, pharmaceutical companies and device-makers had lobbied for the repeal, which was included in the state’s $32.5 billion 2013 budget enacted in July.

    “This narrow change will afford health care providers some flexibility to be educated on new clinically relevant products and allow them to stay informed on advancements in pharmaceuticals and medical devices that benefit patients and lower our health care costs,” Massachusetts Gov. Deval Patrick wrote in a letter announcing his decision to undo the meal ban.

    Drug- and device-makers that provide meals will have to file quarterly reports with the state health department saying where the non-CME presentation took place, what medicines or devices were discussed at the meeting and how much was spent per participant. Also, it will be up to the health department to define through a rule-making process what counts as “modest” food and drinks.

    Other gifts from industry are still banned, and payments to physicians of more than $10 will have to be reported under the sunshine provisions of the Affordable Care Act. Industry payments to physicians will be collected starting in 2013 for inclusion in a nationwide public database.

    Critics of the 2008 state gift ban hailed the change.

    “The Massachusetts Legislature and the governor finally figured out — despite the incessant pleading of the anti-industry activists who instigated the statute — that telling doctors where they can have meals, and the redundant reporting of who pays doctors what, are detrimental to medical education and innovation and do not reduce the cost of health care,” said Thomas P. Stossel, MD, director of the Translational Medicine Division at Brigham and Women’s Hospital in Boston.

    “They could, and should have, junked the whole law,” added Dr. Stossel, co-founder of the Assn. of Clinical Researchers and Educators, which is critical of restrictions on physician-industry collaboration. “In the meantime, other states and academic health centers that have contemplated or enacted such regulations should take notice.”

    Vermont also bans industry from providing meals to physicians. Minnesota bars any gifts to doctors worth more than $50, including food and drinks.

    Device-makers applauded another change in the Massachusetts law that allows them to pay health professionals’ expenses for technical training with a new device. Previously, they were allowed to do that only when a purchase contract was in place.

    “We believe the law will facilitate physician training on rapidly advancing medical technologies, promote patient access to advanced technologies, and align the federal and state approaches to ensure consistent reporting and clear and meaningful disclosure to the public,” said Christopher White, general counsel and senior executive vice president of the Advanced Medical Technology Assn., which represents device manufacturers.

    In May, the Massachusetts Medical Society adopted policy supporting a change in the state’s gift ban so long as the modification conformed to guidelines from the ACCME and the American Medical Association. The AMA Code of Medical Ethics says it is OK for physicians to accept gifts worth $100 or less from industry so long as they benefit patients.

    Medical students wanted ban upheld

    Not everyone in medicine is pleased with the change. A coalition of nearly 100 medical students, residents and academic physicians wrote legislative leaders and the governor in a bid to retain the state’s gift ban in its entirety.

    “It’s really about the trust that’s at the heart of doctor-patient relationships,” said David Tian, a fourth-year medical student at Harvard Medical School in Boston. He chairs the American Medical Student Assn.’s PharmFree campaign that grades medical schools’ conflict-of-interest policies. “We know that patients are concerned that doctors are too influenced by industry.”

    Consumer Reports National Research Center poll of 1,154 Americans in May 2010 found that 69% said drugmakers hold too much sway over physicians’ prescribing.

    “This change creates ambiguity about what’s allowed and what’s not allowed,” Tian said. “We think we owe patients the clarity and the peace of mind of knowing that doctors in Massachusetts aren’t receiving gifts or meals from industry — period.”



    2013 Massachusetts budget conference report, June 27 (sections 108-114, starting on page 237, details rules on industry-provided meals) (link)

    2011 Minnesota statute barring industry gifts to physicians worth more than $50 (link)

    2009 Vermont statute banning gifts from industry (link)

    “Opinion 8.061 — Gifts to Physicians from Industry,” AMA Code of Medical Ethics, June 1998 (link)


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