New Health Law Calls for Increased
Disclosures
By
PETER LOFTUS CONNECT Wall Street Journal
FiDA highlight added
U.S. doctors are bracing for increased public scrutiny of the payments
and gifts they receive from pharmaceutical
and medical-device companies as a result of the new health law.
Starting this month, companies must record nearly every transaction with
doctors—from sales reps bearing pizza to compensation for expert advice on
research—to comply with the so-called Sunshine Act provision of the U.S. health-care
overhaul. The companies must report data on individual doctors and how much
they received to a federal health agency, which will post it on a searchable, public website
beginning September 2014.
Many doctors say the increased disclosures are making them rethink their
relationships with industry, citing concerns about privacy and accuracy, and
worry that the public will misinterpret the information. Some fear patients
will view the payments as tainting their medical decisions, and will lump
together compensation for research-related services with payments of a more
promotional nature.
Drug companies collectively pay hundreds of millions of dollars in fees
and gifts to doctors every year. In 2012, Pfizer Inc., PFE +0.64%
the biggest drug maker by sales, paid $173.2 million to U.S. health-care
professionals. Some companies including Pfizer have decreased these payments in
recent years; Pfizer's total was $195.4 million for 2011.
Consulting and speaking fees are an
important source of income for some physicians, who can be paid tens of
thousands of dollars a year for such services. But now physicians say they will
be much more selective about the work they do and what they will accept from
industry representatives. Some
are even restricting access to their offices by sales reps, or requiring
forms that document the value of anything brought to the office, according to
medical societies.
John Mandrola, a cardiologist in Louisville, Ky., said he has been paid
a total of $1,500 to $2,000 this year by medical-device makers for speaking
engagements. Knowing that such transactions will become public has caused him
to be more cautious about what fees to accept, he said. He avoids industry reps
visiting his office, believing he can get information on new drugs elsewhere.
"I'll continue to weigh the benefits and the negatives, and I think
the Sunshine Act and the public reporting of all this stuff makes us think
about that," said Dr. Mandrola. "And I think that's a good
thing."
A benefit of transparency, Dr. Mandrola said, is that it will help doctors evaluate
medical research from peers if they know whether the researchers receive
payments from certain companies. Still, he worries that the disclosures
could squelch legitimate interactions—for example, when doctors receive
consulting fees to help companies develop drugs and determine their best use.
"I don't think all physician-industry interaction is bad," he
said.
The push for greater transparency was driven by concerns that doctors'
prescribing decisions are tainted by the payments and gifts, as well as
allegations that drug companies have used payments to induce doctors to
prescribe drugs for unapproved, "off-label" uses. Several drug companies have paid
large penalties to settle government allegations of off-label marketing, and
were required to disclose physician-payment data as conditions of the
settlements.
"The idea is that transparency will encourage doctors to evaluate
whether these are appropriate relationships with companies or not," said
Daniel Carlat, a psychiatrist and director of the prescription project at the
Pew Charitable Trusts, which supported the Sunshine Act. He expects patients
won't have much of a problem if their doctors receive $200 worth of
company-provided lunches, but may question doctors who receive tens or hundreds
of thousands of dollars from the industry annually.
Several drug and device makers—including Pfizer and Eli Lilly LLY +0.30%
& Co.—have been posting physician-payment data online for the past few
years. Some U.S. states already require companies to report such information.
But the Sunshine Act will significantly widen the scope because it applies to
most companies—any company whose products are covered by Medicare—and the
government's launch of the database could draw greater public attention.
Richard B. Aguilar, a diabetes-care specialist, received a total of
$42,339 from Lilly for the first three months of 2013, according to Lilly's
online payment database. Dr. Aguilar, who has a private practice in Downey,
Calif., said he speaks about Lilly drugs at programs to teach other doctors,
and the information is consistent with the FDA-approved prescribing labels. He
says the payments are fair compensation for his expertise and travel.
Dr. Aguilar plans to continue serving as a paid speaker, but he says
other doctors are increasingly opting out of attending or speaking at such programs
for fear of what the public will think about the payment disclosures.
Dr. Aguilar said he hopes the public would see the value of physicians
learning new information about drugs from an expert at speaker programs, rather
than having to rely upon their own educational resources to keep current.
"This, in essence, is reducing the number of valuable expert educational
speakers who might otherwise have provided teaching and experience to many
health-care providers," he said.
Some doctors fear the payment data will be inaccurate and could mislead
the public about the nature of their relationships with the industry. Gary M.
Cowan, an ophthalmologist in Fort Worth, Texas, said he has occasionally
attended company-sponsored dinners to hear a lecture from an expert in his
field. He plans to monitor the payments that companies report in his name.
"I think it behooves every physician to look and see what's said
about him," he said.
Drug makers said they've been preparing for the new reporting
requirements and have implemented technology systems to collect the data, but
they will continue to work with physicians because the interactions improve
science and medicine.
The Centers for
Medicare & Medicaid Services, which is implementing the Sunshine
Act, is advising doctors to keep records of all payments and transfers of value
received from industry. Once
the agency receives payment data from manufacturers, it will give doctors about
two months to review the data and work with companies to make any corrections
before it is made public.
CMS also will break down the payment data into more than a dozen
categories—such as meals, travel, research or speaking fees—to give a clearer
idea of the nature of a doctor's relationship with industry.
One key exemption: Companies won't have to report compensation to
doctors who speak at certain accredited events where physicians receive
continuing medical education—as long the sponsoring company doesn't select or
directly pay the speaker, but rather delegates those duties to a third-party
organization. CMS initially proposed to require that such
payments be reported, but granted the exemption in its final rule issued
earlier this year, saying industry support for accredited or certified
continuing medical education is a "unique relationship."
Continuing-medical education providers pushed for the exemption, arguing that
industry support would dwindle if the payments had to be reported.
Stefanie A. Doebler, an attorney with Covington & Burling LLP who
represents health-care companies, said the exemption for indirect payments to
speakers at continuing-medical education events could help sustain industry
support for such programs. However, companies will be required to report
certain other expenses for these programs, such as meals provided to physician
attendees if the cost of each meal is separately identifiable. Some companies
have decided not to fund such meals, she said, which could cause program
providers to charge attendees for the meals.
To ensure accuracy, CMS is required to conduct audits of the data
submitted and levy civil monetary penalties against companies for failing to
submit data, or for submitting inaccurate data. Companies that fail to report
information in a timely, accurate or complete manner face penalties of at least
$1,000 per transaction, with a total maximum annual penalty of up to $1.15
million per company, according to CMS.
CMS plans to publish the data each year on a public website starting in
the fall of 2014. CMS says patients will be able to look up their doctors and
see if they have any financial relationships with companies, which types of
payments they receive and how much.
Some companies are taking steps to prepare the doctors with whom they do
business. Later this year, Roche AG's RHHBY -0.06%
Genentech unit, which sells the cancer drug Avastin, will launch an online
portal called "Sunshine Track," which will allow doctors to review
payment data before it is reported to CMS. "We have implemented extensive
processes to validate all payment information we collect," said a
spokeswoman.
Genentech also allows physicians
to opt out of receiving meals from the company at speaker programs or during
office visits by sales reps. Doctors opting out of meals at speaker programs
must certify this on a sign-in sheet and can either pay for the meal themselves
or not partake, the spokeswoman said.
Write to Peter Loftus at peter.loftus@dowjones.com
Joleen
Chambers comment:
More
empty talk about being patient-centered:
with the exemption allowing industry to support medical education
through a third party, the legislation FAILS to include a % of the funding to
go to consumer organization scholarships making participation in the
conferences possible. Treatment
decision makers and healthcare system designers are notorious for ignoring the
patient stakeholder! Engaged
patient advocates are otherwise unfunded and pay a big price to compete for
conference slots competing with those with professional credentials and a
sponsoring organization.
