Massachusetts' Marketing Code of Conduct

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Abstract

In March, the Massachusetts Department of Public Health released new guidelines regulating financial exchanges between pharmaceutical companies and physicians. The regulations restrict pharmaceutical company gifts to doctors and were authorized as part of a set of measures designed to increase access to health care while slowing rising health care costs in the state. A number of states have adopted similar regulations, but Massachusetts' is the most far-reaching and comprehensive to date.

Purpose of health policy or idea

 

In August 2008, Massachusetts Governor Deval Patrick signed into law Senate Bill 2863, titled "An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care." A section of the law established a new code of conduct for pharmaceutical and medical device manufacturing companies, to be updated and enforced by the state's Department of Public Health. The aim of the new code, according to the level of the law, is to ensure that "the activities of the pharmaceutical or medical device manufacturer agents…benefit patients, enhance the practice of medicine and not interfere with the independent judgment of healthcare practitioners."

The final version of the code was released by the state's health department in March and will take effect July 1, 2009. Companies must file their first public reports on compliance with the code by July 1, 2010 and annually thereafter. Reports will be made available to the public on the Massachusetts Public Health Department website, where the information will be searchable by both company and healthcare provider.

The law

• bans directly and indirectly made cash (and "cash equivalent") gifts to doctors;
• it also bans companies from giving doctors financial incentives to prescribe their drugs or use their products,
• and forces companies to disclose any fee or payment of $50 or more made to "to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in the commonwealth authorized to prescribe, dispense, or purchase prescription drugs or medical device."

Additionally, the law:

• Stipulates that companies may only pay for meals consumed by a doctor him/herself, in his/her work setting, and not as part of an entertainment or recreational event
• Bans companies from giving doctors sports or theater tickets, vacation trips, and other recreational outings-unless those doctors are salaried employees of the company
• Forces companies that sponsor continued medical education courses to comply with the Accreditation Council for Continuing Medical Education Standards For Commercial Support (which prohibit educational presentations made by employees of pharmaceutical companies)
• Prohibits companies from reimbursing doctors for time spent at CME courses, events, conferences, or meetings
• Forces companies to train sales employees in the new methods of conduct and investigate compliance failures; companies must also annually submit descriptions of both to the state health department.

The law makes Massachusetts the only state to require both drug companies and device manufacturers to disclose payments to physicians; it also makes Massachusetts the second state to make such disclosures public.

Main points

Main objectives

 

The new mode of conduct was adopted as part of a series of measures designed to cut the rising costs of health care in Massachusetts and expand healthcare access.  Advocates for this section of the bill cited studies that have recently demonstrated the prevalence of pharmaceutical gift-giving and its influence on physician prescribing behavior. The new law aims, specifically, to cut down on the high costs that result when healthcare providers prescribe unnecessary, "least proven," or costly drugs, or when they avoid prescribing generics.

Type of incentives

Pharmaceutical companies that violate the law will be fined $5000 per violation.

Groups affected

Pharmaceutical companies, doctors

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

Massachusetts' state policy takes inspiration from steps taken by other state legislators, medical schools across the country, and hospital systems, including some in Massachusetts itself. It's approach is therefore not innovative, but it is fairly comprehensive--although consumer advocates have argued that it could have placed even greater restriction on pharmaceutical conduct and spending.

Political and economic background

Senate Bill 2863 was introduced by Senate President Therese Murray in March 2008; the bill included several provisions to curb rising health costs and improve the transparency and efficiency of care. In addition to the new marketing codes of conduct it outlined for drug and medical device companies, the bill established a council to promote transparency of healthcare costs and quality; the Massachusetts E-Health Institute; and an education and outreach program to promote optimal prescription drug use. The bill also allows patients to choose nurse practitioners as their primary care providers. The new modes of drug and medical device company conduct also included in the bill thus comprise part of the state's ongoing measures to reform health care, improve access to care, and slow rapidly rising healthcare costs.

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

Six other states have enacted regulations similar to those about to go into effect in Massachusetts. Minnesota bans industry from giving healthcare providers gifts exceeding US$50, for example; in Vermont, companies must disclose gifts valued at more than US$25. Massachusetts itself has previously considered instituting a ban on gifts to health care providers from pharmaceutical companies.  In 2005, citing the high cost of prescription drugs,  Democratic state senator Mark Montigny, then chair of the senate healthcare committee, proposed legislation that would have banned drug company gifts to doctors, but the measure did not pass. The recently adopted measures make Massachusetts the only state to require both drug and medical device companies to report gifts and payments to providers; the state is also the only one to have authored and made plans to implement its own, comprehensive code of conduct for industry to follow.

According to the Department of Public Health, Massachusetts' new code was modeled on, but exceeds in scope, two voluntary industry codes, one authored by the Pharmaceutical Research and Manufacturers of America and another by AdvaMed, a trade association of medical device makers. The state's new regulations also reflect the spirit of rules recently adopted by individual hospitals and healthcare centers across the U.S. Stanford University School of Medicine (CA), Memorial Sloan-Kettering Cancer Center (NY), and Partners HealthCare (MA), for example, have placed restrictions on drug company sponsorship of continuing medical education courses for doctors. Massachusetts-based Partners, whose new policies will go into effect in October, will also ban pharmaceutical representatives from visiting doctors uninvited and providing doctors with free drug samples.

Initiators of idea/main actors

• Regierung

• Leistungserbringer

• Kostenträger

• Patienten, Verbraucher

• Privatwirtschaft, privater Sektor

Approach of idea

The approach of the idea is described as:
new: Though Massachusetts is not the first state to regulate the pharmaceutical company-doctor relationship, it will be the first whose regulations also apply to medical device companies, and whose law is so comprehensive.

Stakeholder positions

Consumer groups, including the Massachusetts arm of the advocacy group Health Care for All, applauded the new regulations but argued that they could have gone further to protect patients' interests, by instituting a complete ban on gifts from industry to providers. The biotechnology industry and the local hotel and convention bureaus opposed the new rules. Biotech industry representatives argued that the new regulation could stifle research conducted in Massachusetts. Local businesses, meanwhile, argued that Massachusetts would lose tax revenue, as the regulations would prompt major healthcare and medical industries to hold annual conferences in other states; so far, two major meetings have been moved from Massachusetts to other states because of the regulations, according to the Boston Globe.

Actors and positions

Regierung
Therese Murray	sehr unterstützend		stark dagegen
Deval Patrick	sehr unterstützend		stark dagegen
Leistungserbringer
Massachusetts Medical Society	sehr unterstützend		stark dagegen
Kostenträger
Massachusetts Assn of Health Plans	sehr unterstützend		stark dagegen
Patienten, Verbraucher
Health Care for All	sehr unterstützend		stark dagegen
Privatwirtschaft, privater Sektor
Pharmaceutical Research and Manufacturers of America	sehr unterstützend		stark dagegen
Hotel and Convention Bureau	sehr unterstützend		stark dagegen
Massachusetts Biotech Council	sehr unterstützend		stark dagegen

Influences in policy making and legislation

The current measure was proposed by Senate President Therese Murray early in the 2008 legislative session, but a less comprehensive set of restrictions was previously introduced in 2005, by another democratic lawmaker. The new law was lobbied for and in part shaped by input from the Massachusetts Prescription Reform Coalition, a group of healthcare advocacy organizations, healthcare providers, insurance companies, public payers and others; specifically, the coalition pressed legislators to add a gift ban to healthcare cost control legislation. The final measures, as drafted by the state health department's Public Health Council, also took into consideration requests from industry to not place restrictions on support for basic scientific research performed by healthcare providers who are not in their employ.

Legislative outcome

success

Actors and influence

Regierung
Therese Murray	sehr groß		kein
Deval Patrick	sehr groß		kein
Leistungserbringer
Massachusetts Medical Society	sehr groß		kein
Kostenträger
Massachusetts Assn of Health Plans	sehr groß		kein
Patienten, Verbraucher
Health Care for All	sehr groß		kein
Privatwirtschaft, privater Sektor
Pharmaceutical Research and Manufacturers of America	sehr groß		kein
Hotel and Convention Bureau	sehr groß		kein
Massachusetts Biotech Council	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

The new code of conduct has yet to be adopted; it will go into effect in July 2009, and the first round of disclosure reports submitted by industry will become available in 2010. Implementation will directly affect pharmaceutical companies marketing to doctors in the state; it will also affect doctors themselves, as well as patients and payers.

Monitoring and evaluation

The new code of conduct does not specify a plan of monitoring and evaluation, but the health department will be collecting and posting all disclosure reports submitted by industry.

Results of evaluation

 

Expected outcome

Recent reports suggest that the new regulations may cost Massachusetts some amount of revenue, if major industry conferences indeed choose to hold annual meetings and other conferences in other states as a result of the restrictions. However, advocates for the new code argue that it will ultimately help make health care more affordable, by removing some of the incentives that encourage healthcare providers to prescribe newer, more costly brand-name drugs in place of generics-or encourage them to prescribe drugs when none are needed.

Consumer advocates add that the publicly available reports will improve transparency in healthcare practice and reduce healthcare provider conflicts of interest. Consumer and healthcare reform advocates as well as some physician groups have also argued that the new regulations will help improve prescribing practices, by taking one step toward encouraging healthcare providers to make prescribing  decisions based first and foremost on evidence and patient need. Whether the new marketing code of conduct accomplishes these objectives will become apparent only with time.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

 

References

Sources of Information

Massachusetts Office of Health and Human Services. "Massachusetts Proposes Sweeping New Rules Governing Sales and Marketing Tactics of Pharmaceutical and Medical Device Companies." December 10, 2008. www.mass.gov/?pageID=eohhs2pressrelease&L=1&L0=Home&sid=Eeohhs2&b=pressrelease&
f=081210_new_regs&csid=Eeohhs2.

Massachusetts Office of Health and Human Services. "Pharmaceutical and Medical Device Conduct Questions/Answers." www.mass.gov.

Kowalczyk, Liz. "Medical Meetings Falloff Feared. At issue: New Drug Firm Limits." The Boston Globe, January 24, 2009, p. A1.

Senate bill 2863. www.mass.gov/legis/bills/senate/185/st02/st02863.htm.

Author/s and/or contributors to this survey

Elena Conis, Emory University

 

 

Empfohlene Zitierweise für diesen Online-Artikel:

Conis, Elena. "Massachusetts' Marketing Code of Conduct". Health Policy Monitor, April 2009. Available at http://www.hpm.org/survey/us/a13/3