Policy and Medicine

Massachusetts Pharmaceutical and Medical Device Manufactures Code of Conduct: Delays in Release of Data and Changes to the Regulations

As we have covered numerous times on this blog, in 2009, the State of Massachusetts enacted the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC). 

After going into effect on July 1, 2009, the PCOC requires the reporting of payments of more than $50 made to any health care practitioner by industry.  Payments for 2009 were then published on the states website in late November, 2010. 

However, Massachusetts has not published its data for 2010, and is now several weeks behind from last year.  If just one state like Massachusetts—who has been a leader and pioneer in transparency of payments—cannot publish payments on time, one can only speculate how much difficulty and delay the Centers for Medicare and Medicaid Services (CMS) will have publishing payments for 50 states under the Physician Payment Sunshine Act, especially considering CMS is already over 2 months late for proposed regulations. 

Massachusetts Code of Conduct 

Companies must disclose “the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities” (105 CMR 970.009(1)). This includes: 

• Reimbursement of expenses in conjunction with a product training program or event,
• Compensation for serving as faculty at a Continuing Medical Education (CME) event or participation on a Speaker’s Bureau, and
• Compensation for bona fide services.
• This does not include consumers who purchase prescription drugs or medical devices.   

The website explains that any of these transactions may be referred to as “payments.” The $50 total is for each occurrence, not in total for the year. For example, a $55 dinner provided to a covered recipient would have to be reported, but two $30 dinners would not, even though added together, they total more than $50. The EOHHS explains more about PCOC on their website. 

The code applies to pharmaceutical and medical device manufacturers that employ or contract with any person to sell or market prescription drugs or medical devices in Massachusetts.  The PCOC also prohibits by law certain gifts and payments. 

The legislation also requires manufacturers and drug makers to adopt a set marketing code of conduct to help ensure that health care providers were making choices about prescription drugs for their patients based on therapeutic benefits and cost-effectiveness. This code had a number of provisions governing the types and nature of interactions industry could have with physicians.  The Code of was subsequently adopted by the Massachusetts Department of Public Health (DPH).   

The 2010 report gave a breakdown of the top 50 paid physicians, and detailed report of what services the physicians provided and which companies made such payments. On the spreadsheet, the number of payments made is listed, the number of events, as well as the total amount of compensation a physician received. The detailed reports go into what category the payment was for, the specific amount of payment, and which specific company. 

The website includes detailed instructions on how to create custom reports and how to run searches for doctors, manufacturers, and by payment category, which includes eight categories of payments to covered recipients. 

The “gift ban” has been a controversial piece of legislation that has had significant impacts on the pharmaceutical and medical device industry in Massachusetts.  In fact, one year after the Code was in effect, a study published by the Massachusetts Institute of Technology (MIT), analyzed the impact the legislation had on the medical device industry.  The study found that “physician-industry collaboration related to physician education and technology development was impaired by the Massachusetts regulations, with evidence of a larger negative impact on physician education.”  In addition, “within physician education, new device procedure training, non-CME-accredited education, and promotional events experienced the most significant impact.” 

Massachusetts Updates FAQ on Code of Conduct 

Consequently, in late August this year, the Massachusetts Executive Office of Health and Human Services, Department of Public Health, Office of the General Counsel, published an updated Frequently Asked Questions (FAQ).  New changes include: 

Registration and Disclosure Report Submission Process 

Manufacturers subject to the regulation are required to register annually with the Department as part of the regulation.  Annual registration includes paying a fee of $2000. While manufacturers subject to the regulation are required to submit both a disclosure report annually and register annually, the two requirements are separate processes, and the time frames for the two are different. 

A company must designate a compliance officer and may submit one overall disclosure report or several reports at the divisional level. If a company decides to do separate reports for each division, the company is required to register each division separately with the Department, and each division will be required to register annually and pay the annual registration fee of $2000. 

All manufacturers subject to the Massachusetts law must register and pay the annual registration fee, even if there are no data items on their disclosure report. The annual registration renewal fee is due annually during July and August and may be paid electronically through the on-line system established for manufacturer’s annual registration and compliance certification. If a manufacturer does not have any data to disclose for a given period, it should send an e-mail stating that fact to: pharmameddata@massmail.state.ma.us. The Department will deem such emails as meeting the requirement for filing an annual disclosure report. The subject line of emails should contain only the manufacturer’s Department-assigned ID number (the number beginning with CC) and company name. 

A company that anticipates being subject to the Department’s regulations during a disclosure period should submit an initial registration form and the annual fee to the Department as soon as their product launches. 

Which Transactions Need To Be Disclosed? 

Employees of a PMDMC who are also covered recipients are exempt from having payments made to them by their employer reported, but not exempt from reporting by other PMDMCs. 

All marketing activities subject to 105 CMR 970.000 must be reported. Manufacturers are responsible for reporting payments to Massachusetts covered recipients, even if those payments are made by the manufacturer’s agent.

Repeal of Massachusetts Code of Conduct “Gift Ban” Falls Short

 
As we noted earlier in April, the Massachusetts State Assembly voted overwhelmingly 128-22 to repeal the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC). 

Enacted in 2009, the Massachusetts “gift ban” has been a controversial piece of legislation that has had significant impacts on the pharmaceutical and medical device industry in Massachusetts.  After going into effect on July 1, 2009, the Massachusetts (PCOC) required the reporting of payments of more than $50 made to any health care practitioners by industry.  Payments were then published on the states website in late November, 2010.  

After months of debate, the Massachusetts legislature passed the state budget last week, but the final bill did not include any provisions to repeal the gift ban.  The budget also failed to overturn a Massachusetts ban on coupons - the only such state ban in the country.

Clearly, the promises that Governor Patrick made during his re-election campaign were not followed up on. 

Senator Anthony Petruccelli, a Democrat from East Boston, sponsored an amendment that would have changed the current ban's provision, allowing meals to take place, once again, at restaurants.

Massachusetts House Speaker Robert DeLeo told the Boston Herald last month that he looks “at the lifting of the gift ban in Massachusetts as a means to create more business.” Based on conversations he has had with restaurant owners, caterers, and Jim Rooney, executive director of the convention center, DeLeo asserted that Massachusetts is losing business in the state because companies are not willing to come to Massachusetts because of this ban.

However, this argument lost credibility when a review of state tax rolls indicated Massachusetts restaurants actually experienced a 3.2 percent uptick in business during the first four months of the year, according to tax receipts on meals that were reported in the state Blue Book. There were also year-over-year gains in the final months of 2010.

Many patient groups had argued for lifting the ban on coupons because they provide access to people who cannot afford expensive medications.  However, consumer groups successfully countered by claiming that such coupons are disguised marketing to promote brand name drugs.

As for the coupon ban, patient groups argued that such discounting would provide needed relief to people who have difficulty affording their meds. However, consumer groups countered that coupons are marketing ploys that are designed to promote expensive medicines that allow drugmakers to provide lower-cost alternatives (back story).

For now, Massachusetts will continue to enforce the code of conduct and gift ban.  As the federal government moves toward implementing the Sunshine Physician Payment Act this fall, health care stakeholders in Massachusetts will have a number of reporting and disclosure issues to address within the state since many provisions are not preempted by the federal law. 

State House Speaker Calls for Repeal of Massachusetts Manufacturers Code of Conduct AKA “the Gift Ban”

 
As we noted back in April of this year, the Massachusetts legislature voted 128-22 to pass a fiscal 2012 budget amendment repealing the ban on gifts over $50 from pharmaceutical and medical device companies to doctors—also known as the Massachusetts Code of Conduct. The Senate stuck by the ban law, leaving the issue to be resolved by a conference committee eyeing a budget resolution next week.

The bill before the Joint Committee on Community Development and Small Business is one of two efforts to roll back the gift ban, which also required drug and device makers to report payments they make to physicians and other health care professionals. The House in April added a measure to its budget proposal, now being debated in conference committee, that would repeal the law altogether.

The ban, enacted in 2008 to control health care costs and guard against conflicts of interest, has proven to be a “hindrance” to job creation, scaring off companies who would otherwise do business in Massachusetts, according to House Speaker Robert DeLeo.

Backers of the gift ban believed it would address soaring health care costs and argued that gifts from pharmaceutical companies and medical device makers to doctors interfere with the doctor-patient relationship, often swaying doctors to prescribe costlier medications or recommend costlier courses of treatment rather than what is medically necessary.

DeLeo told the Boston Herald that he looks “at the lifting of the gift ban in Massachusetts as a means to create more business.” Based on conversations he has had with restaurant owners, caterers, and Jim Rooney, executive director of the convention center, DeLeo asserted that Massachusetts is losing business in the state because companies are not willing to come to Massachusetts because of this ban.

For example, Dalya’s Restaurant at Bedford Farms was well-equipped to host dinners put on by pharmaceutical companies for doctors, with seating for 30 in a private dining room wired with projection equipment. Owner Frans von Berkhout said doctors liked to come to his restaurant in Bedford because they knew they were in for a good meal. But, when the Legislature in 2008 made such gatherings illegal as part of a broader effort to limit the relationship between physicians and marketers, Dalya’s lost about 10 percent of its business, he said.

However, Representative Lori Ehrlich, a Democrat from Marblehead who sits on the joint committee, said claims that the restaurant industry has been broadly harmed are “tenuous at best.” Others are skeptical of the idea that the gift ban has hurt the economy and point to talks of expanding the Boston Convention and Exhibition Center and Department of Revenue numbers that show restaurant revenues are growing.

Nevertheless, Dayla and other restaurant representatives appealed to a panel of lawmakers to roll back the law and allow the doctor dinners to go on, in the name of supporting small businesses.

Consumer advocates said the change would be a dangerous undoing of a law aimed at protecting patients and curbing prescription drugs costs, even as the national trend is toward stricter controls.

Some members of the Joint Committee on Community Development and Small Business said the negative impact on restaurants seemed like an “unintended consequence” of the 2008 law.  DeLeo said the gift ban is “a hindrance” and runs against his “biggest goal,” job creation. Representative James J. Lyons, a Republican from Andover, further added that the gift ban is “creating the burden on the small businessman.”

Senator Anthony Petruccelli, a Democrat from East Boston, does not support the full repeal but he sponsored the restaurant bill. Under the law today, drug salespeople can bring meals to doctors in their offices or in a hospital setting as long as the cost of the meal does not exceed $50 and if the hospital’s internal policy allows it. He said he does not see a difference between providing a meal in that setting or in a dining room where the restaurant owner can benefit.

Petruccelli’s “pro jobs” bill would change the current ban's provision, allowing meals to take place, once again, at restaurants that have been hammered by the recession. He asserted that his bill, SB 1849, “isn’t weakening anything, but rather, it’s strengthening business and restaurants.”

Sen. Mark Montigny from New Bedford, who was an author of the original gift ban, believes it’s problematic that there is even a discussion that small businesses and restaurants should impact life-saving health policy is the problem in Massachusetts. Montigny asserted that, “the corruption of the sacred doctor-patient relationship by the pharmaceutical industry by schmoozing at fancy restaurants is exactly the consequence that the law was intended to prevent.”

He added further that, “such dinners contribute to the “illegitimate relationship” between physicians and industry,” and that “such connections to marketers can make doctors feel obliged to prescribe high-cost brand name drugs, even when cheaper options may be more appropriate.”

Those in favor of repealing the gift ban recognize that industry is already governed by a strict code of ethical conduct, that doctors with years of medical schooling wouldn’t be plied by a free meal from a drug company, and that the Massachusetts ban far exceeds the strictest standards set by the industry. In particular, proponents of the repeal bill say that restaurants have suffered in neighborhoods like the North End, adjacent to major hospital districts, where doctors are often treated to dinner and presentations by the medical companies they work with.

As small businesses continue efforts to recover from the economic downturn, they will continue to press the Massachusetts legislature to repeal this bill.  Regardless of whether small businesses and restaurants are improving, we should want people to continue the economic recovery, not avoiding it. We still need more jobs and revenue for small businesses to survive during this recovery.  A repeal or revision of the gift ban in Massachusetts will likely be the best way to help companies on their road to recovery and concerns about undue influence by industry are misplaced and unsupported.  

Massachusetts Physician Stands Up to Local Media

 
In an effort to support the “gift ban” which is costing Massachusetts small business millions in revenue and continuing the crusade to publish the “investigative” work of  ProPublica, a local news story from Massachusetts recently discussed the payments made to several practicing physicians in the area.

The article, published in the Telegram, pulled data from the ProPublica database to find that “five Central Massachusetts doctors earned more than $50,000 each — with one making nearly $225,000 — in speaking and consulting fees from eight pharmaceutical companies last year and in part of 2009.”  News must have been slow this week, given this database has been available now for several months.

The first problem with the article is that it editorializes the story, instead of actually presenting news, by using terms such as “lucrative” and “pay off big.”  This is irresponsible journalism. 

For example, the article noted that 48 Worcester County doctors received more than $750,000 in payments for speaking, consulting, educational programs, food, travel, and marketing studies, from Eli Lilly, GlaxoSmithKline, Pfizer, AstraZeneca, Merck, Johnson & Johnson, Cephalon and ViiV, all of which voluntarily disclosed payments nationwide.  That is roughly $15,500 on average per physician, hardly a “lucrative” salary or “big pay off.”  This probably barely covers the amount of time and efforts the doctors spent away from their practices, let alone the fair market value of the educational and consulting services they provided.

Following in the footsteps of ProPublica, the author of the local newspaper article discusses none of the benefits that come from physician-industry collaboration, nor how many physicians received training and education from the programs or how many thousands of patients these physicians helped.  The article does however quote many of the physicians who emphasize the important educational value such payments provide.

According to the article, the top Worcester County earner was Dr. Lawrence M. DuBuske, an allergy-asthma specialist, who received $224,675 from GlaxoSmithKline and AstraZeneca.  We noted last year that Dr. DuBuske resigned from his job at the Brigham and Women’s Hospital in Boston because of a policy they instituted that banned faculty from essentially working with industry.

Dr. DuBuske was paid $199,175 by the company alone for speaking engagements last year, at one point giving talks nearly every other day to fellow doctors as far away as Russia and Argentina.  Given the fact that Dr. DuBuske was speaking almost every other day, simple math would show that he was making less than $2,000 per day, probably less than the amount of money a physician would earn in one day for seeing patients.
Dr. Chettupuzha J. Mathew, a pediatrician, was paid $64,901 by six of the drug companies, including separate payments of $27,300 and $13,300 in speaking fees from GSK.  The fact that Dr. Mathew works for six of the companies not only shows his clear expertise, but that he has no specific allegiance to one company, and most likely, his main motivation is to educate his colleagues and peers.

In fact, Dr. Mathew said the money is “fair compensation for his hours of research in preparation for the seminars, most of which are on diabetes — a disease he himself was diagnosed with five years ago. Another part of the compensation is for lost office time, travel and accommodations.”

Additionally, Dr. Mathew said that about 90 percent of each lecture is about a disease or medical condition, with the last 10 minutes spent talking about medication from whichever pharmaceutical company is paying him. Slides used in the presentation are U.S. Food and Drug Administration-approved.  Dr. Mathew noted that he “would never say OK to talking only about a product. The (drug) companies want doctors to talk, because they are authorities and have to be up to date on things.”

Dr. Amjad Bahnassi and Dr. Richard C. Tomb, both Worcester psychiatrists; and Dr. Mohammad R. Och, a forensic psychiatrist in Worcester, came close to Dr. Mathew with each receiving payments greater than $50,000 from four companies.

Dr. Bahnassi explained to the Telegram, “that the fees were for giving seminars to other doctors on new psychotrophic (central nervous system) medications.”  What exactly is wrong with paying a highly trained and experienced expert fair market value for his services to educate other doctors?  Many physicians feel strongly that it is their duty to do so.

Dr. Bhalchandra Parulkar, a urological surgeon in Worcester who received approximately $20,000 in speaking fees, said seminars are necessary as continuing education for doctors.  Dr. Parulkar, explained that as a surgeon, “there is no peer-to-peer interaction for us, so we need to use our private time to educate ourselves.”  He asserted that the programs “do not reflect on his prescription pattern. It is the only way to talk to other doctors, and it is the only way to educate people about new drugs.”

Dr. Parulkar, who gives talks on the treatment of prostate cancer and urinary incontinence, pointed out that most patients have health insurance provider restrictions that require prescribing generic forms of medications.

Conclusion

What makes this story interesting is that Dr. Mathew himself has diabetes.  When Dr. Mathew learned he had diabetes, “even though he knew about it as a physician, he had to do a lot of research. He attended a seminar in Dallas with 300 doctors, and found out how much knowledge these people have. It opened his eyes.”  From this conference, he recognized the crucial importance of doctors knowing “all of the up-to-date information on the disease from world-known authorities.”

It does not take one health professional being inflicted with a chronic or serious disease to realize that there is a tremendous amount of data and clinical information surrounding the diseases and illnesses doctors and health care practitioners deal with each day.  Basic knowledge is never enough for complex and chronic or serious diseases, especially when there are experts all over the world who know this information and data because they helped participate in creating it one way or another.  As a result, many in those positions feel obligated, as scientists and doctors attempting to progress medicine and patient care, to educate others, and their services should be fairly compensated.

Ultimately, Dr. Mathew told the Telegram that “his seminars, of which other topics have been hypertension and asthma, are given to other doctors and health professionals as continuing education” and that he himself “often attends seminars given by other doctors to learn about the latest practices and medications.” 

Accordingly, the programs that Dr. Mathew both teaches at and attends have value because they provide physicians with further education and training about chronic and serious diseases, the treatments for which are constantly evolving and changing, demanding constant updates.  News media should stop focusing on the value of money physicians are compensate for, and instead try to do some real investigating and see how many lives these educational programs are saving, and how much money to the health care system is being saved. 

Massachusetts Code of Conduct: “Gift” Ban What’s the Purpose

 
As we noted last month, the Massachusetts State Assembly voted overwhelmingly 128-22 to repeal the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC).  Consequently, an article from the Boston Globe covered the developments of this story and several comments were submitted in response.

One commentator worried that if the gift ban is repealed, “the prescription-buying public will end up eating the cost in more ways than one.”  The problem with this comment is that no evidence exists to suggest that the gift ban has saved Massachusetts taxpayers any money.  As such, there is no evidence to show that the gift ban has actually served or fulfilled the purpose it was enacted for.

Another commentator correctly pointed out that the “marketing ban is not about “lobster and chardonnay’’ or restaurateurs and hoteliers,” but rather the mistrust of health care professionals.

Accordingly, the commentator, a psychiatric nurse practitioner who cares for patients in a small private practice, asserted that the industry-sponsored events she has attended are “about continuing education and gathering with area colleagues to share clinical information and wisdom in an informal, non-clinical setting.”

She further asserted that the “dinner programs provided valuable safety information and education on the states of disease that the medications are intended to treat.” Consequently, because of the gift ban, she noted that. “these learning opportunities have declined significantly.”

Moreover, she noted here “deep resentment at suggestions that health care providers make treatment decisions based upon a free meal.” She noted that health care providers “recognize marketing, whether from a pharmaceutical company promoting its medicine or an insurer promoting a generic.”

These health care providers prescribe medications, “regardless of whether they are generic or brand-name, on the basis of many factors, including co-existing medical conditions, the patient’s medical history, and past medication trials.”

The provision that would repeal the gift ban is still being considered in the state’s budget bill.  We will provide updates as soon as they are available.

Massachusetts House Votes Overwhelmingly to Repeal the Code of Conduct AKA the “Gift” Ban

 
 
This week the Massachusetts State Assembly voted overwhelmingly 128-22 to repeal the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct(PCOC). 

Enacted in 2009, the Massachusetts “gift ban” has been a controversial piece of legislation that has had significant impacts on the pharmaceutical and medical device industry in Massachusetts.  After going into effect on July 1, 2009, the Massachusetts (PCOC) required the reporting of payments of more than $50 made to any health care practitioners by industry.  Payments were then published on the states website in late November, 2010.  

The legislation also requires manufacturers and drug makers to adopt a set marketing code of conduct to help ensure that health care providers were making choices about prescription drugs for their patients based on therapeutic benefits and cost-effectiveness. This code had a number of provisions governing the types and nature of interactions industry could have with physicians.  The Code of was subsequently adopted by the Massachusetts Department of Public Health (DPH).  

Consequently, one year after the Code was in effect, a study published by the Massachusetts Institute of Technology (MIT), analyzed the impact the legislation had on the medical device industry.  The study found that “physician-industry collaboration related to physician education and technology development was impaired by the Massachusetts regulations, with evidence of a larger negative impact on physician education.”  In addition, “within physician education, new device procedure training, non-CME-accredited education, and promotional events experienced the most significant impact.” 

Accordingly, health care stakeholders began to press the Massachusetts legislature to revise the legislation and in some cases, to repeal the entire Code of Conduct.  One attempt in July 2010 to repeal the bill passed in the House, but the repeal was never included in the Massachusetts Senate’s economic development reorganization bill. 

This past fall, when elections for Massachusetts Governor took place, all three candidates, including incumbent Deval Patrick—who was later elected—promised during their campaign to repeal or revise the gift ban and code of conduct.  Then, earlier this year, Governor Patrick discussed at a meeting two points about the gift ban.  He noted that the ban was never intended to extend to the state's medical device industry, and thus should be narrowed.”  Governor Patrick also noted that the “state pharmaceutical ban itself was ripe for repeal or modification, since the Obama administration's federal health care overhaul included superseding language”—the Sunshine Physician Payment Act. 

In light of all these developments and the various attempts to repeal the law, the Massachusetts House on Tuesday, April 26^th, 2011, the house voted to repeal the 2008 ban on gifts from pharmaceutical and medical device companies to Massachusetts physicians, tacking the repeal language onto its fiscal 2012 budget bill. The measure would repeal a ban on gifts to physicians, as well as the requirement that companies publicly report payments of at least $50 to physicians and other health providers.

Additionally, Representative Aaron Michlewitz (D-Boston) has filed an amendment (#408) that would remove the restriction on restaurants.  As the Massachusetts Restaurant Association (MRA) noted, the current law prohibits a pharmaceutical or medical device manufacturer agent from paying for meals that are offered, consumed, or provided outside of the health care practitioner's office or hospital setting. These companies are not allowed to hold educational and informational presentations in the restaurants that are surrounding the hospitals.

As a result, MRA asserted that the "restrictions unfairly eliminate functions inside the restaurant, but do not apply to meals at a hospital or office. Restaurants provide an important setting for all types of meetings to take place and shouldn't be excluded as a venue from hosting educational meetings and presentations. Doctors often are faced with high demands and busy schedules; restaurants allow physicians to interact in a private location, removed from the distractions of the office."

Accordingly, MRA recognized that the "mislabeled 'gift ban' has been devastating to restaurants and thousands of middle-class employees," in Massachusetts.

According to the State House News service, “backers of repealing the ban said it had stifled businesses looking to expand in Massachusetts and cost the state revenue from a pair of medical conventions that opted against coming to Massachusetts. Critics of the ban also argued that it had harmed the restaurant industry by preventing pharmaceutical companies from taking doctors out to lunch.” 

Massachusetts Representative Todd Smola (R-Palmer) asserted that, “We need every opportunity possible in order to generate revenue for our economy.”  

In addition, Representative Garrett Bradley, a Hingham Democrat who sponsored the measure, told the Boston Globe that the gift ban is "stifling business.’’  Bradley told the Globe that doctors "have told him that the law limits their ability to learn about new treatments and that companies feel at a disadvantage in Massachusetts."  Accordingly, he asserted that such relationships be regulated at the federal level, under the Sunshine Physician Payment Act. 

Nevertheless, those few representatives that supported the gift ban disputed the contention that Massachusetts had lost out on revenue, pointing to a thriving biotech sector. They also called the ban an important policy to protect patients and ensure the integrity of prescriptions.  Massachusetts Representative Jason Lewis (D-Winchester) asserted that, “a physician choosing to prescribe for his or her patient has undeniably a conflict of interest if he or she is being paid by the company that markets the drug.”  

Now, the House will again have to convince the Senate to include the repeal in the fiscal 2012 state budget, which is expected to be released sometime in May.  

Physician Payment Sunshine: Massachusetts Releases 2009 Provider Payments

 
The Massachusetts Office of Health and Human Services (EOHHS), published the last ½ of 2009 data on industry payments from pharmaceutical and device companies to physicians and health care providers, in accordance with the Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC). The Department, as required by legislation, has created a database to provide the disclosed payment information to the public.

The data is contained in a large spreadsheet. The sheet appears to be organized by manufacturer or company. Then there are specific reports prepared by EOHHS, as described below.

The top recipient of funds was the Boston Healthcare Homeless Project which received $2,000,000 to help homeless patients.  The second was the Joslin Clinic was $1.3 million for continuing medical education grants, to help physicians understand how to better treat diabetes.

For example, EOHHS has provided summaries of the information such as the Top 20 manufacturers who paid physicians and hospitals in 2009 for research and education. There is a more detailed summary of the exact entities (i.e. hospitals) and providers for each specific company as well.

The mix of companies in the top five include:  Boston Scientific ($2,542,165), Eli Lilly ($1,726,503), Ethicon Endo Surgery ($1,641,694), Genzyme ($1,413,250) and Pfizer ($1,337,707).   Medical device manufactures, paid larger payments to few physicians (mostly royalty payments for inventions) Pharmaceutical companies paid smaller payments to thousands of physicians (speaking and consulting).

The report then gives a breakdown of the top 50 paid physicians, and detailed report of what services the physicians provided and which companies made such payments. On the spreadsheet, the number of payments made is listed, the number of events, as well as the total amount of compensation a physician received. The physician’s license number is also published. The detailed reports go into what category the payment was for, the specific amount of payment, and which specific company.

The website includes detailed instructions on how to create custom reports and how to run searches for doctors, manufacturers, and by payment category, which includes eight categories of payments to covered recipients (CRs):

• Compensation for Bona Fide Services (i.e. consulting, Speaker’s Bureaus, etc.)
• CMEs, Third-party Conferences, or Meetings
• Grants/Educational Gifts
• Food
• Education/Training
• Marketing Studies
• Charitable Donation (donations other than donations of prescription drugs, biologics, or devices)
• Other (non-exempt payments to CRs of $50 or more)

The website also allows the public to search for payments to acute care hospitals, and includes a detailed report of such payments as well. For hospitals, the spreadsheet only details the number of companies who made payments to the hospital, the number of events, and the total amount of compensation. The detailed report provides the specific payment category, company, and amount per activity.

There is also a list of the top 100 recipients with the highest totals (excluding hospitals and hospital satellites), based on the data reported, as well as a detailed summary of each recipient. These spread sheets provide the same information above and just combine them.

Background of PCOC

The PCOC requires manufacturers of pharmaceuticals and medical devices to disclose certain transactions (any fee, payment, subsidy or other economic benefit with a value of at least $50) with anyone who prescribes, dispenses or purchases prescription drugs or medical devices in the Commonwealth. This does not include consumers who purchase prescription drugs or medical devices. 

The companies must disclose “the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities” (105 CMR 970.009(1)). This includes:

• Reimbursement of expenses in conjunction with a product training program or event,
• Compensation for serving as faculty at a Continuing Medical Education (CME) event or participation on a Speaker’s Bureau, and
• Compensation for bona fide services.

The website explains that any of these transactions may be referred to as “payments.” The $50 total is for each occurrence, not in total for the year. For example, a $55 dinner provided to a covered recipient would have to be reported, but two $30 dinners would not, even though added together, they total more than $50. The EOHHS explains more about PCOC on their website.

The code applies to pharmaceutical and medical device manufacturers that employ or contract with any person to sell or market prescription drugs or medical devices in Massachusetts.

The PCOC also prohibits by law certain gifts and payments.

Impact of Data

When the bill was passed in the legislature it was presented that this was to help patients understand their physician’s relationships with industry.

This data is basically useless to patients as one needs advanced computer skills just to find the information.   One needs to have excel to access the list.   In one section to make a “custom report” includes 15 pages of instructions.  It is doubtful that any “patient” would waste their time going through those 15 pages.

By the way the data is presented with top 100 lists….it is designed for impressing the media and provide the basis for research by anti industry groups to help write more stories for the media in an endless and useless cycle.    

It is also clear that the PCOC is hopeful that this data will be used for justification for more legislation.   

According to one physician listed in the top hundred many of the payments that were reported, were made to a healthcare provider’s facility and had little to no financial impact on the reported “recipient”.   

The report includes the cost for things such as clinical investigator travel, which though covered by a company these payments, are necessary to conduct clinical trials.

One company that had a total of less than 30 events (payments to physicians) revealed that they spent over $1,000,000 to comply with the law, given there are several hundred companies on the list it is not a far stretch to imagine that more funds were spent on compliance to this law than on the actual payments to healthcare providers.

What is not portrayed in all this “data” is the necessity of many of these payments is for research and development of new products.  The report shows the charitable side of manufactures in that the highest single recipient is Boston Homeless Healthcare Project.

In the coming weeks, media sources will likely use this data to create sensational headlines as we have seen in the case of ProPublica.   Journalists who decide to cover this story and report certain payments have a duty to the public to report fair and objective stories about physician-industry collaboration. This duty goes beyond just asking a doctor why they work with industry, or what role they play, and then quoting critics of industry.

Journalists need to find out the true value doctors are providing to patients and physicians by consulting for companies to discover new drugs or improve new treatments. Absent from many news stories is how numerous diseases have been prevented and treated because of industry. Vaccinations, largely manufactured and developed by industry, have improved public health significantly. Death rates have dropped and survival has increased for severe diseases such as cancer and heart disease. And chronic illnesses such as asthma and diabetes are now manageable. There is a high value in physician-industry collaboration.

Media sources must keep the public’s best interest in mind when covering these payments. There is over a decade of history involved with physician-industry collaboration, and millions of lives have been saved and made healthier because of this partnership. At a time when health care is on the forefront of American policy, when doctors are needed, patients are unhealthy, and our system is overcrowded, industry-physician collaboration is major resource for solving these problems. Now that this information is public, journalists have a duty to use it fairly.

The Physician Payment Sunshine Provision of the Affordable Care Act when implemented will pre-empt much of the Massachusetts report going forward as it pre-empts the reporting of payments to physicians but not to other healthcare providers including pharmacist’s nurses and psychologists.

The state house and Governor Fitzpatrick have both declared that they want to revise the current law, so we may see a change in 2011.

List of Website Links for MA Payments

Background of Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct or “Massachusetts Marketing Code of Conduct”

The Massachusetts Statute (PDF) | RTF

Department of Public Health regulation (105 CMR 970.000) | RTF

Public Health Council Memorandum (PDF)

Frequently Asked Questions (PDF) | RTF

Massachusetts Department of Health and Human Services

Information for Consumers

Basic terms, information and definitions.

Entire Data Set of Reported Payments

Types of Payment Categories Reported (i.e. CME, travel, food, etc.)

Manufacturers

Top 20 Manufacturers Summary (PDF) | Excel
This report shows summary payment amounts made by the top 20 pharmaceutical and medical device-manufacturing companies. It shows only the total amount reported.

Top 20 Manufacturers Detail (PDF 2.38MB) | Excel 1.65MB
This report shows the top 20 pharmaceutical and medical device manufacturing companies by payment amount made, with recipient and category detail.

Physicians

Top 50 Physicians Summary (PDF) | Excel
This report shows the total payment amounts for the 50 physicians with the highest totals, based on the data reported. It shows only the total amount reported.

Top 50 Physicians Detail (PDF) | Excel
This report shows the total payment amounts for the 50 physicians with the highest totals, based on the data reported. It shows the totals and then breaks out the detail by manufacturer and category of payment.

Hospitals

*Important note on hospital reports: One hospital may have many locations (campuses, satellites, clinical labs, etc.) that are related to the way they are licensed. These reports attempt to aggregate those locations.

Acute Care Hospitals Summary (PDF) | Excel
This report shows the total payment amounts for acute care hospitals based on the data reported. It shows only the total amount reported.

Acute Care Hospitals Detail (PDF) | Excel
This report shows the detail for the payments to acute care hospitals based on the data reported. It shows the totals and then breaks out the detail by manufacturer and category of payment.

Covered Recipients (Excluding Hospitals)

Top 100 Covered Recipients, Non Hospital, Summary (PDF) | Excel
This report shows the total payment amounts for the 100 recipients with the highest totals (excluding hospitals and hospital satellites), based on the data reported. It shows only the total amount reported.

Top 100 Covered Recipients, Non Hospital, Detail (PDF) | Excel
This report shows the total payment amounts for the 100 recipients with the highest totals (excluding hospitals and hospital satellites), based on the data reported. It shows the totals and then breaks out the detail by manufacturer and category of payment.

Custom Reports

This section offers specific instructions on how to look for payments in three ways.

Payments by Category

If you are looking for what types of payments a company made to any covered recipients (and the total dollar amount of those types of payments), search in Payments by Category.

Detailed Instructions (Word 1.19MB) 

Run Payments by Category Report

Payments Made by Manufacturer

If you are looking for all the payments a particular company made and to whom, i.e., which covered recipients (for example, doctors, hospitals, pharmacists), search in Payments Made by a Manufacturer.

Detailed Instructions (Word 2.5MB)

Run Payments by Manufacturer Report

Payments Made to a Recipient

If you are looking to see if a particular health care provider received any payments, search in Payments Made to a Recipient.

Detailed Instructions (Word 3.08MB)

Run Payments Made to Recipients Report

Massachusetts Gubernatorial Candidates Unanimously Support Repeal of the Gift Ban

 
In politics it is rare for politicians running for the same off office to agree on anything.  But this week a unique agreement arose between the three gubernatorial candidates in Massachusetts.

As the negative consequences surfaced in Massachusetts on the Pharmaceutical and Medical Device Manufactures Code of Conduct i.e. “the gift ban” and built up over time, individuals in the commonwealth running for governor realized the significant disapproval of the gift ban and as a result, the State House News Service reported yesterday that whoever the next governor is, the gift ban may be gone.

The gift ban legislation was highlighted this week during a 90-minute gubernatorial forum on the biotechnology industry in Massachusetts, sponsored by MassBIO. During the forum, Democrat Deval Patrick, Republican Charles Baker and Independent Tim Cahill all said “they saw defects with the current gift ban.” According to the News Service, “Baker and Cahill said they would fight to remove the ban outright, while Patrick said he would seek to conform gift rules to those that the pharmaceutical industry uses to police itself.”

In particular, Cahill asserted that he would “work to repeal” the gift ban, while Baker noted that the “national health reform signed in March would make the gift ban unnecessary.” Baker added further that the gift ban is a “terrible drag” on the medical and restaurant industries. He pointed to the terrible damage the legislation has caused to tons of restaurants in Massachusetts.

Cahill, the state treasurer, said the current gift rules “put the onus on the companies and mostly the medical profession and treat them... as if they’re guilty of making a sin because they grabbed a pen or someone’s giving them a meal.”

Background

On August 11, 2008, Massachusetts Governor Deval Patrick signed into law S2660, also known as the “Gift Ban.” Over the past two years, this legislation has required pharmaceutical and medical device manufacturing companies to report to the state Department of Public Health any payment or gift of more than $50 made to a healthcare professional. The state then makes the payments public by displaying them on the state’s website.

The legislation also requires manufacturers and drug makers to adopt a set marketing code of conduct to help ensure that health care providers were making choices about prescription drugs for their patients based on therapeutic benefits and cost-effectiveness. This code had a number of provisions governing the types and nature of interactions industry could have with physicians.

Proponents of the bill such as Governor Patrick asserted that the gift ban would “help contain the skyrocketing costs of health care, while ensuring transparency and continued quality of care for all Massachusetts residents.”  Massachusetts Senate President Therese Murray added that the legislation would help decrease the cost of care by increasing transparency for consumers.

At the time, Governor Patrick also asserted that he was “confident that the Department of Public Health would safeguard the confidentiality of companies’ trade secrets and proprietary information and protect against roadblocks to medical research or the education of health care providers.” Despite his hopes, the gift ban has had significant and unintended consequences, many of which opponents of the bill predicted two years ago.

For example, a recent thesis by Daniel W. Wolf, MBA, a student in the Biomedical Enterprise Program in the Harvard-MIT Division of Health Sciences and Technology, examined the impact of the legislation on innovation in Massachusetts. Based on his survey of a number of stakeholders including industry, academia, and physicians, Mr. Wolf’s thesis found that the enactment of the Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) has “increased the barriers between physicians and medical device companies, impairing physician-industry collaboration on technology development, new device training, and medical education.” He further recognized that PCOC causes “additional concerns from Massachusetts-licensed physicians that industry withdrawal will impair their ability as physicians to innovate and deploy new device therapies, educate the next generation of physicians, and provide optimal patient care.”

Another negative impact from PCOC is that pharmaceutical and device companies have been “curtailing sales, marketing and training activities in Massachusetts” in order to comply with the new rules, and “some outside companies are avoiding Massachusetts altogether.” In fact, an article in the Boston Globe noted how the new laws have resulted in “fewer jobs related to training, medical device sales and clinical trials.” Moreover, one article noted how the gift ban is having a negative effect on primary care physicians in Massachusetts because it is cutting off opportunities for clinicians to gather new scientific information and exchange real-world clinical information. Additionally, the gift ban has resulted in companies withdrawing funding for fellowships, professorships, and other faculty positions and departments in Massachusetts.

The gift ban has also had a negative impact on business in Massachusetts. For example, one major medical group cancelled its annual multimillion-dollar convention in Boston, citing the state’s new law cracking down on free gifts, meals and other goodies handed out to doctors by the pharmaceutical industry as the reason. In fact, the gift ban law sent a chill to the convention and medical meeting community in Boston. The restaurant business also voiced its concerns about the gift ban bill because of declining business and revenue associated with less medical meetings. Moreover, medical device companies noted the significant burden the legislation placed on them considering the fact that many physicians needed to work directly with industry to learn how to use certain medical devices. Even Merck decided to close one of its facilities in response to the legislation. 

This past summer the Massachusetts state house voted to repeal the “gift ban”.  Members of the Association of Clinical Researchers and Educators including Thomas Stossel, MD were instrumental in outlining the pitfalls of the law on medical innovation.

Other Issues

Another issue that was discussed during the forum was proposed legislation in the Massachusetts House that would permit pharmaceutical companies to offer coupons for prescription drugs to consumers.” However, that bill never gained approval before the formal sessions ended in July, something that Cahill pointed to as the governor’s “failure of leadership.”

Opponents of the coupons believe it is merely a “ploy” aimed at luring consumers to purchase expensive brand name drugs. Supporters “reject the assertion, saying doctors are still required to exercise discretion when writing prescriptions and state laws include strict requirements that generic drugs be prescribed over brand names whenever possible.” Patrick predicted that he could get the coupon bill done and fix the gift ban together in the next legislative session. Meanwhile, Baker said he would “move aggressively” to support the coupon proposal, also known as “co-pay assistance.”

In addition, Patrick promoted his success as governor by pointing to the “supercluster” of biotech companies and activity in the industry that has taken place in Massachusetts. Nevertheless, this statement however, did not account for the negative impact on jobs, training, and funding in the biotech industry that has incurred since the bans enactment, as we described above.  Consequently, Baker said to support the industry, he would lower taxes “across the board” to bolster all industries, including biotech.

Ultimately, this forum clearly showed that politicians in Massachusetts have responded to the concerns of patients, physicians, and industry. The efforts of these groups are gaining recognition, and these candidates are beginning to acknowledge what many asserted from the beginning: that the gift ban stifles innovation, chills research, and ultimately will hurt patients. As a result, it seems likely from the long list of negative consequences, and the large number of people this legislation has affected, that the next governor of Massachusetts will repeal this ban.

 

Massachusetts Keeps the Code of Conduct in Place

 
This weekend the Massachusetts legislature passed an economic stimulus package that failed to include a repeal of the Pharmaceutical and Medical Device Code of Conduct . 

As we reported in early July, the Massachusetts State House passed a repeal of the Pharmaceutical and Medical Device Code of Conduct, referred to as the “gift ban.”  Amendments to keep the gift ban law in place were defeated.

The repeal however, which was part of the state economic stimulus package, was stalled for most of July because policymakers in Massachusetts were busy negotiating other pieces of the legislation including gambling, a sales tax holiday, a measure that would help the state locate new wind farms, and a bill that would limit many employers’ access to criminal records.

But the Boston Globe reported that “legislative leaders were hoping to enact the measures before midnight on Friday, when the legislative session is scheduled to end.”

Consequently, although “the House version of the bill would have reversed a ban on pharmaceutical firm gifts to health care workers, the compromise measure left the gift ban in place.” In other words, if the bill is passed in its current form, the Gift Ban will be repealed.

According to legislative leaders on the ground in Massachusetts the votes just weren’t there in the senate to repeal the Code, and they are hopeful that next legislative session they will have the votes to repeal this very bad law.

There has been tremendous impact the gift ban has had on innovation and medicine in Massachusetts over the past year, which was evidenced by a recent thesis from MIT/Harvard.

The house passing the repeal shows that legislatures have been listening to constituents and businesses such as restaurants, hotels, and conference centers that have all been negatively affected by the gift ban. More importantly, since medicine and healthcare is such a large field and presence in the state, it is clear that Massachusetts policymakers are reacting to the possibility that many companies will take their income, taxes, jobs, and numerous other beneficial factors to other states.

Massachusetts Code of Conduct Hurts Primary Care Physicians

 
Last night, I read an interesting account by a local Massachusetts physician Kate Atkinson, MD on the effect the Massachusetts Pharmaceutical and Device Code of Conduct i.e. the “gift ban” is having on primary care physicians in Massachusetts.   This was originally published on Kevin MD.

 Six years ago, I organized a group of female healthcare practitioners for a women’s medical journal club. A multidisciplinary team of doctors and NPs from primary care and sub-specialties regularly attended monthly dinners. Invited speakers presented on a variety of topics and over the course of a meeting we exchanged insights while challenging each other on how best to manage our challenging patients.

Our group grew close enough to provide some much needed emotional support – something, any physician can use but more so for women providers who try to juggle work and family issues. Ultimately, we became more skilled at our craft, helping patients, while building strong working relationships with colleagues from across the community. To the surprise of some, these meetings would not have been possible without industry support. The cost of dinner and a babysitter priced many of us out once we lost that support and our group has dwindled sadly since the ban.

This is the so-called ‘wining and dining’ that is slowly being eliminated by heavy-handed conflict of interest policies being promulgated by academic medical centers (AMC) and by misguided “gift bans” being enacted by state legislatures. AMC’s purport that severing industry ties will ensure a more “pure” clinical environment (Note: no claim is made about improving patient care). And legislators have been convinced that inhibiting interactions between pharmaceutical companies and physicians will control spiraling health care costs, a myth deftly debunked by Drs. Tom Lee and James Mongan in Chaos and Organization in Health Care (neither of whom could be considered industry shills).

Although their stated goals differ, the consequences of such policies and laws are the same: Productive interactions supported by those marketing products as well as those discovering and developing products, are quickly becoming extinct.

With the rapid advances in medicine and skyrocketing health care costs, there could not be a worse time for “bans” that choke off opportunities for clinicians to gather new scientific information (even pharmaceutical marketing material must pass FDA review for scientific content and balance) and exchange real-world clinical information. Primary care, considered the bedrock of a strong health care system, is already in dire condition and cannot afford to have partially informed clinicians. Cost-effective care truly depends on access to information, whether the source is biased towards new therapies (industry) or biased towards cheap therapies (insurers and academic detailers), clinicians need all of the available information.

Primary care already suffers from low reimbursement rates relative to the value of care provided, high medical school debt-to-income ratios, and excessive insurer paperwork burdens that diminish valuable time with patients. It is no surprise that few physicians-in-training are choosing primary care and many current practitioners are choosing early retirement or are simply abandoning medicine altogether.

I can attest that running a small primary care practice is a Herculean feat and additional barriers to my success, like bans, do little to “bend the curve” of primary care decline. Like many of the other clinicians that attend our meetings, I run my own practice, and see ~100 patients per week. I also have four school-aged children. And as much as our meetings allowed us to learn about the latest products or get new information on older products, they were also about interacting with fellow colleagues. They provided a forum for mutual education and support. They also fostered detailed case discussions, sharing of medical pearls on clinical management and even tips on how to better interact with male colleagues.

We averaged 15-20 providers at each of our dinners and often hosted medical students and residents, modeling interdisciplinary work in a small town setting. (And I would challenge almost any small town to demonstrate such an vital educational group with such staying power over the years.) We also invited a highly selective group of clinicians to lecture on topics that we otherwise may not have found the time to learn by simply wading through the medical literature. In fact, in one six-month span we heard on topics including hormone-therapy, EMRs, ophthalmology, osteoporosis, alternative medicine and pain management topics. We even had a sex therapist talk which was most illuminating to many of us. In exchange for hosting our Journal Club the pharmaceutical representative used to be entitled to one talk to our group each year and we had say over who the speaker was and the topic.

Since our State enacted its “gift ban,” we have been unable to find a sponsor for our meetings. The medical society outright declined our request because our meetings were not considered sufficiently inclusive (i.e., females only). Post-“ban” we have limped along paying our own way but the truth is medical practice is demanding and chaotic for us all, and possibly even more so for women with families – the logistics alone have stymied us. We are not close to an academic teaching hospital and even our community hospital is a 40-minute drive for me and many of my colleagues. Therefore, there are no other resources of this quality and nature in our community. And if we tried to host the meetings in our homes our family members would pose a distraction. A once staunchly loyal group of 15-20 now often sees 5-6 women attending.

We limped along this past year despite immediately losing all of our NP’s and more recently losing most of our primary care doctors as well. (Sad but true that the cost of a dinner was prohibitive.) It has been painful to watch such a dynamic and supportive group dwindle over the past year. We had something truly special. In the past many people wanted to join our group – even male doctors – and we frequently received unsolicited requests from individuals interested in presenting to the group.

When the “gift ban” was passed, it seemed as if the vote was influenced exclusively by those with access to the big teaching hospitals (which ironically, according to a recent report by the Massachusetts Attorney General, we now know they are the real cost-drivers in the state)–they even wrote it so that their grand rounds could still be subsidized by pharmaceutical companies– and that there was little understanding of what we, the practitioners beyond the Boston “medical Mecca” needed. The ‘country doctors’ were not even consulted.

Many recognize that it is hard to practice primary care. And most recognize that it is particularly hard to practice in our State. What few appreciate is that it is even harder to practice in a rural area of our State, where access to resources is more limited. We had a solution that made us both better clinicians and better equipped to survive another day as clinicians for our patients – two things our nation and Massachusetts desperately need – yet politics prevailed and took this solution from our community and its patients.

Kate Atkinson is a family physician in Massachusetts