"Dr. Nogah Haramati, a radiologist based in New York, recently cancelled a meeting with a vendor — one of the many equipment manufacturers and software developers who routinely offer free dinners and lectures to ply their wares.
Haramati, who works for Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, said he was concerned that even attending a lecture with a dinner would lead to his name being listed in a public database outlining that tie to the company. Such disclosures could put him in conflict with policies set out by his employer.
"It's very easy to run afoul of that database," he said.
Similar thoughts are going through the minds of thousands of physicians across the country with the imminent rollout of new federal regulations that require medical device and drug manufacturers to disclose their financial dealings with all healthcare providers. “Physicians as well as teaching hospitals are going to be wary of accepting some of the transfers or payments that they may have taken in the past now that these things will see the light of the day,” said Robert Hussar, a lawyer with Manatt, Phelps & Phillips.
The legislation requiring public disclosure of the financial relationships between healthcare vendors and physicians has been widely discussed in policy circles for years. Critics claimed payments for speaking, consulting, research or even the small trinkets and meals delivered during routine sales calls unduly influenced physician choices and inflated healthcare costs. To combat those effects, Congress required public reporting of those payments in a publicly accessible database. The legislation, labeled the Physician Payment Sunshine Act, was included in the 2010 healthcare reform law.
Starting in August, manufacturers and providers will begin collecting data about so-called “transfers of value” that they make to physicians and teaching hospitals. The data will be reported to the CMS, which is expected to make it public for the first time in September 2014.
The rollout of the Sunshine Act sets up several likely responses by the companies and the physicians and is expected to alter the long-standing and sometimes lucrative financial relationships between the two parties."
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“Whether transparency will lead to fewer relationships is really the million-dollar question,” said Dr. Daniel Carlat, director of the Pew Charitable Trusts' Prescription Project. "The kinds of relationship that may drop off may well be the most inappropriate relationships."
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"It's expected that drug and device manufacturers will seek new ways to keep frustrated physicians from walking away from valued consulting or research-based relationships. If "doctors are unhappy, then those doctors may choose to end those relationships," Pew's Carlat said. “That's not something the companies want to see.”
The Sunshine Act requirements will be very familiar to companies that in recent years have been forced to sign corporate integrity agreements to settle government lawsuits alleging the companies had used physician payments to improperly market drugs for off-label uses or as kickbacks to get them to use specific devices. Dozens of drug and device companies disclosed their financial relationships with physicians under the settlements.
Six states have also adopted payment-disclosure laws. The Sunshine Act will be the first federal law to require such reporting for all drug and device companies."
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"In a May 14 letter to the CMS, Pew urged the regulator to address a number of concerns, including defining large-scale conferences as more than 500 attendees to encourage individual reporting of meals and gifts at smaller events. It also wants clarification that indirect payments made to professional physician organizations will not be exempt from reporting unless they are designated for nonphysicians.
Such physician organizations often set practice guidelines that can influence adoption of drugs and devices.
"If the grant is designed as unrestricted, it looks like the companies will not have to attribute payments to specific physicians,” Carlat said. “We're talking about millions of dollars being spent on different activities."
Prescription project director Danny Carlat identifies issues with the Physician Payments Sunshine Act requiring further clarification and guidance. Addressing those would ensure that manufacturers can appropriately implement the final rule, and enable consumers to benefit from transparency reports published by the Centers for Medicare & Medicaid Services.
More infoThe Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value.
More info"The Obama administration issued a new rule this month that requires the makers of prescription drugs and other medical products to disclose what they pay doctors for various purposes, like consulting or speaking on behalf of the manufacturer. This overdue rule adds much-needed weight to previous, more limited disclosure requirements."
More infoAllan Coukell, director of medical programs for The Pew Charitable Trusts, issued the following statement in response to the Centers for Medicare & Medicaid Services' final rule for implementing the Physician Payments Sunshine Act, which will bring transparency to the financial relationships between physicians and drug and medical device companies.
More infoIn 2011, the pharmaceutical industry spent nearly $29 billion on drug promotion — more than $25 billion on marketing directly to physicians and almost $4 billion on advertising directly to consumers (mainly through television commercials). This multi-pronged approach is designed to promote its products by influencing doctors’ prescribing practices.
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"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."
More infoDuring a session at the American Psychiatric Association's annual meeting on conflicts of interest, experts delved into the link between psychiatry and the pharmaceutical industry. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
More infoDr. Daniel Carlat, Director of the Pew Prescription Project, appeared before the U.S. Senate Special Committee on Aging to testify about the importance of implementing the Physician Payments Sunshine Act as quickly as possible.
More infoPew Prescription Project Director Daniel Carlat opines in the Philadelphia Inquirer: "Monetary relationships among doctors and drug and device companies are not inherently bad; in fact, they are crucial for advancing medical research and patient care. Yet they can also skew prescribing practices and research results. That's why transparency and education are such an elegant solution: They allow these often important relationships to exist, but only on the condition that other professionals and patients are fully informed about them."
More info"Every five years, lawmakers, lobbyists, patient groups and agency regulators line up to take their shot at changing how things get done at the Food and Drug Administration."
More infoThe Pew Charitable Trusts “Pew” and Medtronic, Inc. are pleased to jointly comment on the Department of Health and Human Services, Centers for Medicare & Medicaid Services proposed rule implementing Section 6002 of the Affordable Care Act.
More infoCopyright(c) 1996-2012 The Pew Charitable Trusts. All Rights Reserved.
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