humani nil a me alienum puto

random rants about news, the law, healthcare law, economics and anything I find amusing

Variations in Healthcare Spending – Anchor-Tenant Theory and Fraud and Abuse?

The New Yorker recently had a very interesting expose discussing one of the fundamental economic challenges of healthcare reform.  (Gawande, Atul, The Cost Conundrum: What a Texas town can teach us about health care, June 1, 2009).  Peter Orszag gave a presentation last year at the American Health Lawyers meeting in San Franscisco that I was able to hear.  Mr. Orszag, President Obama’s budget director and formerly head of the Congressional Budget Office, has observed repeatedly (and is quoted in this article as saying) that “[n]early thirty per cent of Medicare’s costs could be saved without negatively affecting health outcomes if spending in high- and medium-cost areas could be reduced to the level in low-cost areas.”  He, and many healthcare economists’ observe, that there is a tremendous amount of variation in healthcare spending throughout various regions of the country that simply cannot be explained after controling for demographics, illness indexes/cases mixes, cost indexes and other similar factors.  And, most importantly, outcomes are no better in higher spending areas.

This New Yorker article paints a narrative story surrounding this frequent observations by looking at case of McAllen, Texas.  McAllen has the particular notoriety of having the highest per capital Medicare spending in the nation.   I think it is an important read for healthcare counsel because of some of the author’s tangential commentary linking McAllen’s higher per capita spending with a culture that could have support higher incidents of fraud and abuse.

According to the article, McAllen spends (using 2006 data) approximately $15,000 per Medicare enrollee.  This is more than twice of what El Paso, Texas, with very similar demographics and population factors, pays.  It is also more than twice what the region surrounding the Mayo Clinic spends.  Ironically, the per capital Medicare spending is more than McAllen’s per capita income.

The New Yorker author discusses this fact with some local physicians who have no idea of this distinction for their community:

One night, I went to dinner with six McAllen doctors. All were what you would call bread-and-butter physicians: busy, full-time, private-practice doctors who work from seven in the morning to seven at night and sometimes later, their waiting rooms teeming and their desks stacked with medical charts to review.  Some were dubious when I told them that McAllen was the country’s most expensive place for health care. I gave them the spending data from Medicare. In 1992, in the McAllen market, the average cost per Medicare enrollee was $4,891, almost exactly the national average. But since then, year after year, McAllen’s health costs have grown faster than any other market in the country, ultimately soaring by more than ten thousand dollars per person. “Maybe the service is better here,” the cardiologist suggested. People can be seen faster and get their tests more readily, he said.  Others were skeptical. “I don’t think that explains the costs he’s talking about,” the general surgeon said. “It’s malpractice,” a family physician who had practiced here for thirty-three years said. “McAllen is legal hell,” the cardiologist agreed. Doctors order unnecessary tests just to protect themselves, he said. Everyone thought the lawyers here were worse than elsewhere. That explanation puzzled me. Several years ago, Texas passed a tough malpractice law that capped pain-and-suffering awards at two hundred and fifty thousand dollars. Didn’t lawsuits go down? “Practically to zero,” the cardiologist admitted. “Come on,” the general surgeon finally said. “We all know these arguments are bullshit. There is overutilization here, pure and simple.” Doctors, he said, were racking up charges with extra tests, services, and procedures.  The surgeon came to McAllen in the mid-nineties, and since then, he said, “the way to practice medicine has changed completely. Before, it was about how to do a good job. Now it is about ‘How much will you benefit?’ ”

via Annals of Medicine: The Cost Conundrum: Reporting & Essays: The New Yorker.

What is the basis for the higher per capita Medicare spending?

To determine whether overuse of medical care was really the problem in McAllen, I turned to Jonathan Skinner, an economist at Dartmouth’s Institute for Health Policy and Clinical Practice, which has three decades of expertise in examining regional patterns in Medicare payment data. I also turned to two private firms—D2Hawkeye, an independent company, and Ingenix, UnitedHealthcare’s data-analysis company—to analyze commercial insurance data for McAllen. The answer was yes. Compared with patients in El Paso and nationwide, patients in McAllen got more of pretty much everything—more diagnostic testing, more hospital treatment, more surgery, more home care.  The Medicare payment data provided the most detail. Between 2001 and 2005, critically ill Medicare patients received almost fifty per cent more specialist visits in McAllen than in El Paso, and were two-thirds more likely to see ten or more specialists in a six-month period. In 2005 and 2006, patients in McAllen received twenty per cent more abdominal ultrasounds, thirty per cent more bone-density studies, sixty per cent more stress tests with echocardiography, two hundred per cent more nerve-conduction studies to diagnose carpal-tunnel syndrome, and five hundred and fifty per cent more urine-flow studies to diagnose prostate troubles. They received one-fifth to two-thirds more gallbladder operations, knee replacements, breast biopsies, and bladder scopes. They also received two to three times as many pacemakers, implantable defibrillators, cardiac-bypass operations, carotid endarterectomies, and coronary-artery stents. And Medicare paid for five times as many home-nurse visits.

The author discusses the high utilization and costs with various hospital executives, who, like the physicians interviewed, also do not know that McAllen is the most expensive place in the country for Medicare beneficiaries.  The executives of the hospitals, to the author’s belief, authentically did not know their peculiar notariety and, not even recognizing it as an issue, had no truly thoughtful responses as to why it might be.

Local executives for hospitals and clinics and home-health agencies understand their growth rate and their market share; they know whether they are losing money or making money. They know that if their doctors bring in enough business—surgery, imaging, home-nursing referrals—they make money; and if they get the doctors to bring in more, they make more. But they have only the vaguest notion of whether the doctors are making their communities as healthy as they can, or whether they are more or less efficient than their counterparts elsewhere. A doctor sees a patient in clinic, and has her check into a McAllen hospital for a CT scan, an ultrasound, three rounds of blood tests, another ultrasound, and then surgery to have her gallbladder removed. How [are the hospital executives] to know whether all that is essential, let alone the best possible treatment for the patient? It isn’t what they are responsible or accountable for.  Health-care costs ultimately arise from the accumulation of individual decisions doctors make about which services and treatments to write an order for. The most expensive piece of medical equipment, as the saying goes, is a doctor’s pen. And, as a rule, hospital executives don’t own the pen caps. Doctors do.

The article suggests, with only a little explanation, that the variation between communities such as McAllen and, in contrast, El Paso or other lower cost regions (with at least the same if not better quality institutions) might be due to an  “anchor tenant theory of economic development.”  Certain markets develop their own economic character, similar to how a mall may be defined by its anchor tenant.  So, the theory goes, certain “anchor tenants” in a market may allow, for example, the development of regional specialization (e.g., biotechnology development in certain cities – Boston, San Franscisco and not in others with similar apparent resources).   Twisting this model a bit, the author posits that the entrepenurial focus of physician medicine in McAllen, changing from the 1990s to present, may be a significant part of the increase in costs.  McAllen was near the median in per capita spending a decade ago.  Importantly, the author then goes on to point out anecdotal evidence of some serious antikickback statute violations — solicitation by certain unnamed physicians of medical directorships in exchange for referrals to hospitals and home health agencies.

This linkage — which is not well developed by the author — is nonetheless a beware moment.   If higher per capita Medicare spending is linked by government enforcement agencies as a proxy for potential higher rates of fraud and abuse behavior, one might see a new horizon for focusing fraud enforcement .  Perhaps this is a stretch – but an interesting linkage is being made here by the author.  It is all the more important due to the prestige of the publication and that the fundamentals of this story find their genesis in the economic theory of healthcare inflation that is the focus of leaders within the current administration.

The author goes on to make a fairly classical example of the challenges of asymetical information in healthcare coupled with the fee-for-service basis of physician payments:

Providing health care is like building a house. The task requires experts, expensive equipment and materials, and a huge amount of coördination. Imagine that, instead of paying a contractor to pull a team together and keep them on track, you paid an electrician for every outlet he recommends, a plumber for every faucet, and a carpenter for every cabinet. Would you be surprised if you got a house with a thousand outlets, faucets, and cabinets, at three times the cost you expected, and the whole thing fell apart a couple of years later? Getting the country’s best electrician on the job (he trained at Harvard, somebody tells you) isn’t going to solve this problem. Nor will changing the person who writes him the check.

The author aruges that changing the payor (i.e., government plan competitor, single payor system) will not change this problem.  Even putting the consumer on the hook through medical savings accounts or high deductible plans won’t solve it (if a physician recommends a cardiac bypass, is the patient going to negotiate with the cardiologist, radiologist, anesthesiologist, cardiothoracic surgeon and hospital over expense or the scope of the procedure?).

Then the author suggest that only flipping the economic model might fix this.  The author isn’t quite specific in how this might be accomplished, although he goes to length to contrast the McAllen “anchor-tenant” model with other “anchor-tenant” models of healthcare (e.g., Mayo), suggesting this is the crux of the problem – what kind of medical care provision culture the United States will be developing based upon the economic incentives that are established by insurance payor systems we perpetuate or change through reform.  Not by who cuts the check.

This is worth the read because it sets a story narrative for the harder data Mr. Orszag and others have frequently discussed as healthcare reform is debated.

Filed under: AKS, Comparative Effectiveness Rearch, Health Law, Reform, , , , ,

Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences, May 11, 2009, Grande et al. 169 (9): 887

A new study finds that subtle exposure to branded pharmaceutical items, even without the social interactions of gifting, influence medical school student attitudes towards brands.  The study has some interesting discussion regarding “boomerang” response by some of the students from the institution that had strong rules prohibiting gifts.  This reaction may have some bearing on current efforts to ban gifts and marketing materials at healthcare institutions as well as the so-called “Sunshine Laws” at the federal and state levels regarding transparency of pharma and medical device marketing and financial arrangements, including gifting.

From the study’s commentary:

Our study finds that subtle exposures to branded pharmaceutical promotional items influences implicit attitudes of medical students toward pharmaceutical brands. The observed effect was modified by training year and school. Among third-year medical students, no significant experimental effects were observed. However, among fourth-year medical students there were significant effects at both schools in our study. Students at Miami responded as we hypothesized, shifting their preferences in the direction of the branding exposure (ie, Lipitor). However, students at Penn had a boomerang response, ie, a behavioral response opposite of the implied marketing intent.22 The most likely explanation for the difference across class year is that, as students advance in their training, they begin to form attitudes toward various treatment options that can be primed with branded promotional items. In comparison to third-year students, fourth-year students have had greater clinical experience and greater exposure to their clinical teachers and prevailing institutional practices.

The divergent effects at our 2 study schools are an interesting finding. At Penn, exposure to the branded items produced less favorable implicit attitudes. One potential explanation for this effect is that the strong school policy provided an external warning about specific persuasion tactics underlying pharmaceutical marketing. This information may have motivated some form of resistance by the audience23 that could have taken the form of simple message rejection or active counterarguing or careful message scrutiny.24 The policy therefore may have heightened the ability of the Penn students to exercise what has been termed “persuasion coping effectiveness”,25 which produces a goal within oneself to achieve one’s own current learning or attitudinal goal independently of what the marketer seems to be trying to accomplish. The differential attitudes observed in the marketing survey, with the Penn students exhibiting significantly more negative attitudes than those in the national sample or for the Miami students where no policy exists, support this explanation. At Miami, where students had more positive attitudes toward marketing, exposure to a branded promotional item likely primed more positive implicit associations.

via Arch Intern Med — Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences, May 11, 2009, Grande et al. 169 (9): 887.

Filed under: Conflicts of Interest, Health Law, , , ,

Sunshine in Vermont… Again. Vermont Senate Bill (S-048)

As reported in the NY Times Blog yesterday, the State of Vermont, which already had fairly strict provider financial arrangement reporting requirements for pharmaceutical companies doing business in the state, is slated to significantly limit gifts to providers by both pharmaceutical and medical device companies.  The new law, which, according to the NYT blog, will be signed by the governor, will prohibit all but certain enumerated gifts, revise reporting requirements by pharmaceutical companies and expand the reporting requirements to medical device manufactures.

The legislative bodies findings and intent, obviously influenced by the reporting thus far provided under the previous version of the law, outline its concerns, stating its belief that marketing practices can influence the rise in health care spending and that “state of Vermont has a substantial interest in cost containment and the protection of public health.” The legislature cites a number of findings leading to its adoption of the legislation:  (i) an IOM study linking gifts to prescribing behavior, (ii) recent federal crackdowns on medical device manufacturers’ alleged antikickback  violations (see my related post on the federal Sunshine Act), (iii) significant spending in the relatively small state of Vermont on pharma marketing (“[i]n fiscal year 2008, pharmaceutical manufacturers reported spending $2,935,248.00 in Vermont on fees, travel expenses, and other direct payments to Vermont physicians, hospitals, universities, and others”), (iv) the pharma industry’s focus on 100 physician opinion leaders for almost two-thirds of pharma’s spend (“approximately $2.1 million in payments went to physicians…[with the] top 100 individual recipients received nearly $1,770,000.00 in fiscal year 2008”) and prevalence of pharma’s spend throughout Vermont’s 4,573 licensed health care professionals, with 2,280 being recipients.   Based upon the legislation, the Vermont lawmakers certainly are frowning on the nearly $1M spent on food, noting that many food recipients received $1,000 or more spent on them.  One individual recipient, in fact, apparently receive over $15,000 in food.

The legislature concludes that the “act is necessary to increase transparency for consumers by requiring disclosure of allowable expenditures and gifts to health care providers and facilities providing health care [in order] to reduce real or perceived conflicts of interest which undermine patient confidence in health care providers and increase health care costs by influencing prescribing patterns.  Limitations on gifts and increased transparency are expected to save money for consumers, businesses, and the state by reducing the promotion of expensive prescription drugs, biological products, and medical devices, and to protect public health by reducing sales-oriented information to prescribers.”

The new law prohibits “any manufacturer of a prescribed product or any wholesale distributor of medical devices, or any agent thereof, to offer or give any gift to a health care provider.”  It provides that the  attorney general “may bring an action in Washington superior court for injunctive relief, costs, and attorney’s fees and may impose on a manufacturer that violates this section a civil penalty of no more than $10,000.00 per violation. Each unlawful gift shall constitute a separate violation.”

Permitted items that are not deemed prohibited gifts include:  (i) samples, (ii) limited short term evaluation use loaners of medical devices not exceeding 90 days, (iii) reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product, (iv) provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function, (v) scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association, (vi) rebates and discounts for prescribed products provided in the normal course of business.  Certain items are not prohibited and are considered “allowable expenditures.”  These include (i) certain limited sponsorship of a significant educational, medical, scientific, or policy-making conference or seminar, (ii) certain limited honoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide significant educational, medical, scientific, or policy-making conference or seminar, (iii) bona fide clinical trial arrangements, (vi) certain limited bona fide research projects, (v) expenses relating to technical training of individual health care professionals on the use of a medical device pursuant to a written agreement.

Manufactuers need to report “any allowable expenditure or gift … to any health care provider” or “to an academic institution or to a professional, educational, or patient organization representing or serving health care providers or consumers” in the following categories:

  • “The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of a medical device by a health care provider or patient.”
  • “The provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.”
  • “The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.”
  • “Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.”
  • “Labels approved by the federal Food and Drug Administration for prescribed products.”

Manufacturers must report, on form specified by the attorney general, the value, nature, and purpose of each allowable expenditure, and permitted gift along with (i) the name of the recipient, (ii) the recipient’s address, (iii) the recipient’s institutional affiliation, (iv) prescribed product or products being marketed, if any; and (v) the recipient’s state board number.

Failure to manufacturer of prescribed products that fails to disclose as required by the law subjects the manufacturer to a civil penalty of no more than $10,000.00 per violation. Each unlawful failure to disclose, however, constitutes a separate violation.

The legislation also directs the attorney general’s office to conduct a review, in consultation with the commission on health care reform, of the advisability of modifying the law to require the disclosure of information about the provision of pharmaceutical samples to health care providers.   At present, samples are expressly excluded from the reporting regime.

If signed into law, the law will take effect July 1, 2009, but reporting activities under new regime will be implemented in 2010 reporting period.

Clearly the legislature had cost on its mind in enacting the law, as it also has tasked a state workgroup to explore generic alternative formularie recommendationss.   The workgroup is to report to the legislature by January 15, 2010 on the list generated.

Filed under: AKS, Conflicts of Interest, Health Law, , , , ,

Factors Influencing Physicians Prescribing NAIDs

In his Healthcare Economist blog, Jason Shafrin, Ph.D. (just recieved – congrats) reported on a recent study in The American Journal of Managed Care concerning the prescribing habits of Nonsteroidal Anti-Inflammatory Drug (NAIDs) among physicians.  The study, entitled Pharmaceutical Company Influence on Nonsteroidal Anti-Inflammatory Drug Prescribing Behaviors, describes, through interviews with academic medical center physicians from a variety of specialities, their prescribing habits in order to elicit the general themes that influence their behavior.  As Jason summarizes from the article, they are mostly influenced by the following:

  1. Direct Marketing by pharma detailers.
  2. Patient requests for medication, often driven by direct-to-consumer pharmaceutical advertising.
  3. Habits formed during medical school. Often, these habits are influenced by drug rep visits while the physician was in medical school.
  4. Journals, electronic peer-reviewed literature, and professional meetings.
  5. Local physician expert opinion and practice guidelines.
  6. The physician’s own experience prescribing drugs to patients.

The purpose of the study was to “describe the taxonomy of methods used by pharmaceutical companies to influence physicians’ nonsteroidal anti-inflammatory drug (NSAID) prescribing behaviors and to elicit physicians’ perceptions of and counterbalances to these influences” since there was a recognized poor adherence to prescribing guidelines for NSAIDs.  The study recognized that physicians describe detailing and direct contact with pharmaceutical representatives, requests from patients inspired by direct-to-consumer advertisements, and marketing during medical school and residency training as primary influences.  The study also reports that physicians described practice guidelines, peer-reviewed evidence, and opinions of local physician experts as important counterweights to pharmaceutical company influence.

The study concludes that the “social and communicative strategies used by pharmaceutical companies can be adapted to improve physicians’ adoption of guidelines for safer NSAID prescribing. Communicative interactions between local experts and other physicians who prescribe NSAIDs may be the critical target for future interventions to promote safer NSAID prescribing.”

Aanand D. Naik, MD and Aaron L. Woofter, MD et al,  (2009) “Pharmaceutical Company Influence on Nonsteroidal Anti-Inflammatory Drug Prescribing Behaviors,” Am J Manag Care. 2009 (published online April 1, 2009 and found online April 18, 2009 at http://www.ajmc.com/web-exclusives/managed-care/AJMC_09Apr_Naik_Exclusiv_e9toe15?utm_source=Listrak&utm_medium=Email&utm_term=%2fweb-exclusives%2fmanaged-care%2fAJMC_09Apr_Naik_Exclusiv_e9toe15&utm_content=jshafrin%40ucsd.edu&utm_campaign=AJMC+e-Table+of+Contents+(April+Web+Exclusive)).

via [AJMC] – American Journal of Managed Care.

Filed under: AKS, Conflicts of Interest, Drug Policy, Health Law, Pharmacy, , ,

PartnersHealthCare Announces Industry Relationship Policy

The WSJ Health Blog in its April 10, 2009 posting reported that Parterns Healthcare, which includes Harvard-affiliated Mass General, had issued a report recommending tighter restrictions on industry relationships with its physicians.

The news release by Partners listed key recommendations from its report:

Prohibition of all gifts, including meals and funding for meals, provided directly to staff by industry for their personal use, on a Partners site or off site. This ban also applies to Partners institutions accepting industry gifts for this purpose.

Development of mechanisms to have free drug samples distributed only through the hospital pharmacy or some other centralized system, and not provided directly to or distributed by physicians.

Requiring that industry representatives have written invitations defining the purpose and terms of visits before having access to Partners sites and staff.

Establishment of a process to identify and manage significant financial interests held by physicians in companies that make products they prescribe or use in their practices.

Acceptance of industry funding for educational programs and fellowships only if provided through a centrally pooled institutional President’s Fund at each hospital or approved by a newly-created, Partners-wide Educational Review Board.

Establishment of a robust, tiered approach to evaluate research-related conflicts of interest, including continued prohibition of certain high-risk circumstances.

Adoption of a stricter policy holding certain officials to a higher standard because of their influential positions within the organization.

Strengthened oversight of permitted outside activities, including a ban on faculty participation in industry speakers bureaus, an express prohibition on faculty being listed as authors on papers ghostwritten by others, and a more rigorous internal review process for certain outside activities.

Development of an enhanced infrastructure, including creation of a new Conflict of Interest Review Committee, responsible for education, oversight, and enforcement of Partners policies and practices in regard to industry interactions.

The system plans to adopt revised policies and procedures by October 1, 2009 and acknowledges that a significant training and education program will be necessary during the roll-out of these changes.  The 30 page report details the commissions charge, its process, its internal review, external factors and recommendations. The press release link is below.

CommissionPressRelease_PartnersHealthCare2009.pdf (application/pdf Object).

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Researcher Faked Data in Sleep Apnea Study – Health Blog – WSJ

The WSJ Health Blog reports another individual fabricating research study data.  Not much about industry ties, except that he later went on to work in industry.

“Robert Fogel, a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients, the Office of Research Integrity at HHS said…Fogel, who worked at Brigham and Women’s Hospital at the time but later moved on to work at Merck, told a former supervisor in 2006 that he had falsified the data, the Scientist reports.”

via Researcher Faked Data in Sleep Apnea Study – Health Blog – WSJ.

Filed under: Conflicts of Interest, Health Law, , , ,

Hospital Gets Subpoena Tied to Doctor’s Studies – WSJ.com

The WSJ and its WSJ Health Blog report that Baystate Medical Center has been subpeoned for records related to Scott S. Reuben, a Massachusetts doctor accused of faking data used in at least 21 anesthesiology studies.  The accused physician, was also on the faculty of Tufts University medical school.

Some of his research was funded by Pfizer Inc., Wyeth and Merck & Co., Wyeth said it provided $10,000 in grant money to Dr. Reuben from 2001 to 2003.  According to the WSJ Health Blog, Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.

via Hospital Gets Subpoena Tied to Doctor’s Studies – WSJ.com.

Filed under: Compliance Programs, Conflicts of Interest, Health Law, ,

Johns Hopkins Bans Free Drug Samples, Gifts from Industry – Health Blog – WSJ

As reported in the April 8, 2009 WSJ Health Blog, John Hopkins is the latest to adopt a restrictive policy on ‘on interaction with industry.’  the new policy “bans free drug samples and says doctors can’t participate in consulting gigs in which they’re essentially paid for not doing anything…”  The ban “applies to Hopkins’s medical school, hospitals and clinics”.   It also “prohibits gifts, entertainment or food — regardless of value — from drug and medical device companies.”

As for consulting relationships, the policy says that payments that are “without commensurate associated duties are considered gifts and are prohibited.”

According to the Health Blog, Hopkins representatives do not “believe it has a problem with …’sham’ consulting arrangements, but they’ve been a subject of concern around the country.”  For there doctor’s sake, one would hope not since that might be a bit more problematic than a meal or gift, no?

From the policy:

[On Gifts:]To avoid the risk of conscious or subconscious bias in decision-making, it is the Johns Hopkins Medicine policy that faculty and staff, employees, students, trainees, and volunteers may not accept gifts or entertainment (see below for food and meals), regardless of value ***

[On Consulting Arrangements:] Consulting arrangements involving personal compensation without commensurate associated duties are considered gifts and are prohibited. Specific policies regarding outside consulting are set forth in the School of Medicine’s policy on conflict of commitment and in JHM organizations’ personnel policies. ***

[On Food/Meals]: With certain exceptions, outlined below, industry-supplied food and meals are considered personal gifts and will not be permitted and may not be accepted at any JHM member organization site, in connection with activity conducted under the auspices of or using the name of any JHM member organization or in the context of professional activity off-site. ***

[On Unrestricted Gifts to Instituti0n:] Through unrestricted gifts, industry generously supports the educational, research, and patient care missions of Johns Hopkins. Gifts must be made to the University or JHHS and deposited in a departmental account.  There may be no quid pro quo, nor any limitations nor conditions placed on gifts that are inconsistent with Fund for Johns Hopkins Medicine policies and applicable regulations.***

[On Samples:] The practice of accepting free pharmaceutical samples risks interference with one’s prescribing practices since industry representatives often provide the newest and most costly drugs. Therefore, free pharmaceutical samples and vouchers for free pharmaceutical samples may not be accepted.***

[On Access by Pharma Reps:] [A]ccess by pharmaceutical, medical testing and other industry representatives to individual physicians must be restricted to non-patient care areas. Access will be permitted only on invitation from a physician, nurse, pharmacist, respiratory therapist, or other professional healthcare staff member.***

[On Speaking Gigs:] Faculty members may speak at an industry-sponsored program only if the faculty member retains full control and authority over professional material the faculty member presents and does not allow such communications or presentations to be subject to prior approval by any commercial interest other than approval for the use of proprietary information.

via Johns Hopkins Bans Free Drug Samples, Gifts from Industry – Health Blog – WSJ.

Filed under: AKS, Compliance Programs, Conflicts of Interest, Health Law, , ,

High-End Health Care in the Boardroom – DealBook Blog – NYTimes.com

Spouse travel at Footlocker, out of state physicals at Stryker and executive physicals at Norfolk Southern.

Directors and executives at Norfolk Southern may be among the healthiest out there, judging from the proxy that the company filed Tuesday.  That’s because the railroad operator covers up to $10,000 a year in medical expenses for each nonexecutive director as well as a group of top executives, including Charles W. Moorman IV, its chairman and chief executive. Mr. Moorman spent $4,800 on his physical last year and another $4,800 in 2007. Four other executives spent between $3,800 and $4,800 on the perk.

via High-End Health Care in the Boardroom – DealBook Blog – NYTimes.com.

Filed under: Concierge Medicine, Conflicts of Interest, Executive Compensation, Health Law, , ,

Footing the Bill for a Spouse’s Travel – DealBook Blog – NYTimes.com

Thank goodness I don’t have to travel much anymore.  But if I do, I want to be the chief executive at Footlocker.

According to Foot Locker’s preliminary proxy statement, “Mr. Halls’s wife may accompany him on up to eight business trips each fiscal year at the company’s expense.” …The company says the perk is an exception to its normal policy on spousal travel, because of Mr. Halls’s “extensive international travel obligations.” …Last year, Mr. Halls’s spousal travel reimbursement cost the company $123,000 plus another $112,000 to cover the taxes that would have been owed on the perk. In the filing, the company notes that starting this year, it will no longer cover the gross-up.

via Footing the Bill for a Spouse’s Travel – DealBook Blog – NYTimes.com.

Filed under: Compliance Programs, Conflicts of Interest, Health Law, Personal Posts, , ,

Stanford Medical School to Disclose More About Industry Comp – Health Blog – WSJ

According to the April 1, 2009 WSJ Health Care Blog, Standford is to publicly disclose on its web-site those of its medical school faculty receiving industry money greater than $5,000 — although specific amounts will not be disclosed.

Stanford University’s medical school said today it expects to post an online list by the end of the summer showing its staff members who received payments, royalties, stock grants and other compensation topping $5,000 in 2008. Companies providing the compensation to each staff member on the list will be identified but the dollar amounts staffers received above $5,000 won’t be included. Among the targets of the Grassley’s investigations was Alan Schatzberg, who chairs Stanford’s psychiatry department.

via Stanford Medical School to Disclose More About Industry Comp – Health Blog – WSJ.

Filed under: Conflicts of Interest, Health Law, Reform, Risk Management, , ,

Doctors Urge End to Corporate Ties – NYTimes.com

The NY Times Health Blog on April 1 reports that JAMA published a paper in its April 1, 2009 edition.   The paper recommends that medical professional associations adopt stricter conflict-of-interest guidelines.  Mere disclosure of financial ties to drug and medical device companies is not sufficient.  They also advocate barring members industry financial ties from entering leadership positions and participating in influential committees within the association.

The blog further reports that:

The authors are particularly adamant that professional medical associations should neither accept corporate money to underwrite the development of practice guidelines nor allow members with financial ties to industry to serve on committees that develop the guidelines, which are usually widely adopted as the gold standard for medical practice. … “The consensus here was quite clear: You do not want the piper calling the tune,” said David J. Rothman, a professor of social medicine at Columbia University. “We ask that these groups make every effort to get to zero percent and, knowing that it is very difficult to do that, that they move as rapidly as possible to no more than 25 percent,” referring to how much of their support should come from industry.

Commentary from Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America was also reported in the blog, reminding of the amount of money that industry provides for necessary research and other support of healthcare providers.

“The vast majority of the research is funded by pharmaceutical companies,” Ms. Powell said. Important decisions regarding practice guidelines might be made, she said, by “very junior people who have no experience.”

via Doctors Urge End to Corporate Ties – NYTimes.com.

Note a similar post in the WSJ Health Blog.

Filed under: Conflicts of Interest, Drug Policy, Health Law, Pharmacy, Reform, , , ,

Authors of Psychiatric Guidelines Get Funding from Drug Makers – Health Blog – WSJ

The WSJ Health Blog reports a significant portion of those writing the APA’s treatment guidelines have financial ties to industry.

[A]mong 20 authors of the guidelines for treatment of depression, dipolar disorder and schizophrenia, 18 had at least one financial tie to a drug maker, and 12 had ties in at least three categories, such as consulting, research grants, speaking fees or stock ownership.The guidelines are a powerful influence on the way doctors treat patients. This week, big-name docs argued in a JAMA paper that medical specialty groups, which put out the guidelines, should tightly limit their funding from industry. (Drug trade group PhRMA responded that industry funding helps doctors obtain important medical information.) Earlier this year, amid news that many heart-disease guidelines aren’t backed up by rigorous scientific testing, an editorial in JAMA argued that guidelines “often have become marketing tools for device and pharmaceutical manufacturers.”

via Authors of Psychiatric Guidelines Get Funding from Drug Makers – Health Blog – WSJ.

In the referenced Boston Globe article one of the authors Dr. Roy Perlis, after noting that the guidelines in his area promote generics and non-pharmeceutical interventions states:

“My job is to find better treatments for my patients. These are awful illnesses. People really suffer,” he said. “And the people who are most responsible for developing new treatments right now are the pharmaceutical companies. What is being lost in all this is that if I didn’t work with them, I couldn’t do my job as a scientist – the part of my job that says we have people who are suffering that need new treatments.”

Filed under: Conflicts of Interest, Health Law, Pharmacy, Reform, Risk Management, , , ,

JAMA Sets New Policy in Wake of Disclosure Flap – Health Blog – WSJ

There seems to be a conflicts of interest fight brewing between JAMA, a professor of neuro-anatomy and BMJ.  According to WSJ Health Blog, “Leo, a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn., faced criticism from editors at the Journal of the American Medical Association when he published a letter in another medical journal, BMJ, that highlighted an unreported conflict of interest in a study published by JAMA…The editorial… scolds Leo for publishing his letter in the BMJ before JAMA weighed in on the matter. In addition, the editorial says JAMA contacted the dean at Leo’s medical school in an attempt to apply pressure from above…As a result of the flap, JAMA says it is adopting a new policy under which anyone asserting that study authors have failed to disclose conflicts of interest should keep the matter confidential until JAMA investigates… That move is already generating controversy.”  What I find interesting is (1) apparently, the discovery of the potential conflict arose when Dr. Leo questioned material omissions in the study; (2) JAMA apparently contends that it is inappropriate for a third party to write about an apparent undisclosed conflict until JAMA has done its own thorough investigation and reported back; (3) apparently all this disagreement devolved into some name calling.   Interesting reading.

Read the JAMA editorial at http://jama.ama-assn.org/misc/jed90012pap_E1_E3.pdf

Read the Dr. Leo’s WSJ statement at http://online.wsj.com/public/resources/documents/leo_statement_for_WSJ.htm

Read the BMJ letter at http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503

via JAMA Sets New Policy in Wake of Disclosure Flap – Health Blog – WSJ.

UPDATE.  In the March 30, 2009 WSJ, WSJ reports that the American Medical Association (which controls JAMA) has appointed an oversight committee to investigate charges that the top editors threatened a researcher who publicly faulted a study in the publication. via Medical Group Seeks Probe of Its Journal – WSJ.com.

Filed under: Conflicts of Interest, Health Law, , ,

Physician Payments Sunshine Act of 2009

Interesting bill introduced in the 111th Congress (SB 301) by Mr. Grassley.  After recent settlements involving Medtronics and then a host of other medical device manufacturers in late 2007 (Johnson & Johnson subsidiary DePuy Orthopaedics, Zimmer, Biomet and Smith & Nephew) who provided lavish trips and sometimes sham consulting and IP royalty payments to physicians allegedly to induce their ordering of the firms’ devices, the Congress is considering forcing pharma and medical device manufacturers to disclose all financial arrangements with physicians and medical groups greater than $100/year.  The financial arrangements would be posted in a manner that would be accessible to the public.  Failure to disclose would subject the companies to up to $150,000 (if innocent) or $1m Civil Monetary Pentalties if knowingly.  It is of note that disclosure was used by the OIG in the deferred prosecution agreements with these companies.   See, for example, Zimmer’s home page at www.zimmer.com.

Search Results – THOMAS (Library of Congress).

Filed under: AKS, CMP, Conflicts of Interest, Health Law, , , , ,

A Trip to the Doctor’s on the Company Jet – DealBook Blog – NYTimes.com

NYT’s Dealwatch Blog reports on the medical device company Stryker’s proxy statement detailing executive perquisites.

What does it say about the local medical community when the chief executive of a large medical technology company has to hop on the corporate jet and fly to another city to get an annual physical? That’s the situation at Stryker, based in Kalamazoo, Mich., which disclosed in its proxy that Stephen P. MacMillan, its chief executive and president, “traveled to a physical exam on the company aircraft.” *** Stryker “believes that its perquisites practices are conservative[.]”

via A Trip to the Doctor’s on the Company Jet – DealBook Blog – NYTimes.com.

Filed under: Conflicts of Interest, Executive Compensation, Health Law, , ,

Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ

In its Health Blog, the WSJ reports on March 25, 2009:

GlaxoSmithKline last year promised to publish payments to U.S. docs for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is expanding on its promise.For clinical trials starting in 2010 and after, Glaxo said yesterday it will publicly report the money it pays U.S. doctors and their institutions to carry out the studies*** Disclosing more and more about payments to health-care professionals is a trend du jour in the industry. The list of drug companies and device makers that have said they’ll start reporting payments to docs includes Pfizer, Eli Lilly, Merck and Medtronic. Exactly what payments get reported varies from company to company.  All those self-imposed reporting plans could soon be moot. The Physician Payment Sunshine Act, which has been kicking around for a while, would create national rules for what payments drug and device makers have to publicly disclose.

via Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ.

Filed under: AKS, Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, , ,

Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com

The March 25, 2009 NYT reports:

[T]he American Psychiatric Association announced on Wednesday that it would end industry-financed medical seminars at its annual meeting. ***The association, the field’s premier organization, said it would also phase out meals at the meeting paid for with industry money. ***The association has been reviewing the income it received from industry sources since early 2008, Dr. Stotland said, looking for potential conflicts. Since then, Congressional investigators, led by Senator Charles E. Grassley, Republican of Iowa, have found that several prominent psychiatrists who received hundreds of thousands to more than $1 million from drug makers did not report that income to their employers, as required by federal and most academic rules. ***The psychiatric association said it had no plans to eliminate drug advertisements in its journals, commercial exhibits at meetings, or industry-sponsored fellowships for doctors.

via Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Health Law, , , ,

An Overseer of Medical Trials Comes Under Fire – NYTimes.com

The NYT reports:

“The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist. *** The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast. ***Over a five-year period, Coast reviewed 356 study proposals and rejected only one[.] *** In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation.***In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O. ***In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

via An Overseer of Medical Trials Comes Under Fire – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Who’s To Blame For The Financial Crisis? : NPR

I, for one, am beginning to loathe that I waste any of my time watching cable TV news and opinion programs.  The quality of the talking heads on MSNBC, Fox and CNN is (perhaps always was) in free fall.  I can, perhaps, tolerate Chris Mathews a bit; I terribly miss Tim Russert — but he mainly did his Meet the Press show rather than much specific to cable.  But I don’t realize most of the cable programs are just so much cotton candy until I hear real debate.

I most realize it when I actually listen to real, substantive, witty, thoughtful, hard, and fact laden debate.   Like the difference between a quality hard-wood cabinet maker and a rough carpenter.  Yeah, they both work with wood, but one’s a craftsman and the other, well, a day laborer.

Listen to this recent debate on NPR’s program Intelligence Squared.  I’ve not heard the full podcast quite yet.  I caught the last half of it airing this evening on my way home from work (far too late).   The debate – the proposition – “Blame Washington More Than Wall Street for the Financial Crisis” – was timely and really made me think.   The panel exchanged polite barbs (distinct from the often thoughtless vitriol of left/right pundits on cable programs), pushed their position with both factual support as well as comical retorts.  There’s a few great lines in this — the best that I heard was from John Steele Gordon who stated that

While Wall Street constantly needs reform…it does not need reform as much as Congress…Institutions tend to evolve in ways that benefit their elites … the poster child for this is [not Wall Street but] Congress…People lament that Wall Street took its checkbook down to Washington to get the regulation it wanted rather than have stricter regulation.  But Wall Street was not [in Washington] debauching a virgin, it was paying a harlot.

In the end, the position taken by Mr. Gordon and Niall Ferguson (for the proposition) won more of the audience’s change over vote.  They convinced me.  While there’s plenty of blame to go around, when systemic risks crashes down the house, those holding the reigns of the regulatory structure are ultimately accountable.   In any event, if you are following the debate concerning the financial crisis, you’ll want to hear this and see who convinces you.

via Who’s To Blame For The Financial Crisis? : NPR.

Filed under: Personal Posts, , , , , ,

AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News

In the March 23, 2009 AMA News, a consulting firm reports that the heyday of the pharma detailer may have already peaked and is headed into decline:  “At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates’ U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.”

According the article and the survey, fewer physicians are spending less time with the detailers.  More types of providers are requiring advance appointments.

The article and survey reports that “[p]hysicians’ openness toward visits by pharmaceutical company detailers varies by practice ownership and size.

Refuse
to see
Require
appointments
Practice size
1 to 2 doctors 14.3% 32.5%
3 to 5 16.7% 36.1%
6 to 10 23.1% 45.0%
More than 10 44.0% 45.5%
Practice ownership
Non-hospital 22.1% 37.8%
Non-health system 22.3% 37.5%
Hospital 31.2% 44.6%
Health system 34.7% 52.0%

Source: “Physician Access: U.S. Physicians’ Availability to See Drug and Device Sales Reps,” SK&A Information Services Inc., released February”

The article also reports significant decreases in detailing staff.  “Experts estimate the U.S. pharmaceutical sales rep force eventually will be cut 25% from its 2007 peak of more than 100,000. Here are some of the biggest layoffs announced in the last year.

Drugmaker Sales rep cuts
GlaxoSmithKline plc 1,800
Merck & Co. Inc. 1,200
Wyeth 1,200
Schering-Plough Corp. 1,000
Sanofi-Aventis 650

Source: News accounts”

via AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News.

Filed under: Conflicts of Interest, Health Law, , , , , ,

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