CMS' final rule of the "Sunshine Act" included in the federal health law didn't exactly roll out according to schedule. As part of the larger Patient Protection and Affordable Care Act, the Sunshine Act was intended to require all medical device and drug companies to report payments and gifts they provided to physicians and teaching hospitals by the end of this month. Those companies would have found it all but impossible to comply with the law, however, because CMS didn't issue its final rule on the requirement until Feb. 1 this year, about 15 months after its intended October 2011 release.
As a result of this delay, CMS has pushed the deadline back one year. Now, industry manufacturers and group purchasing organizations must begin gathering records on "transfers of value" to physicians and providers starting Aug. 1, 2013, to be reported to CMS by March 31, 2014, along with information regarding physicians' ownership or investment interests.
In the dark. At the same time CMS' overdue final rule was issued, a study co-conducted by Portsmouth, N.H.-based healthcare software company MMIS showed that more than 50 percent of the 1,000 physician respondents, even with the 15-month delay, were unaware of the Sunshine Act, and 43 percent said the law's impact could affect their relationship with industry.
There are some valid reasons why some on the provider side of the equation are so uninformed on the matter, says MMIS President and CEO Michaeline Daboul. For one, opponents of the PPACA spent over a year trying to repeal it. Those efforts were foiled after the Supreme Court's 2012 decision to uphold nearly all of the law, but a final rule had still not been issued, stalling medical associations from pushing to prepare providers to comply with the act.
"Physicians are blaming their [medical] societies because they've done very little to educate their members, but all of these organizations were waiting on a final rule. There was nothing to educate them on otherwise," Ms. Daboul says. "Manufacturers did not feel it was their job at the time to educate their physician customers. Why would you want to tell your customers about something when you don't even know how it'll be implemented?
"Now, you're going to see a rhythmic increase in education from pharmaceutical companies that want to educate customers and hopefully from societies as well" she adds.
Reporting. After manufacturers and GPOs supply the financial data to CMS next March, providers and physicians will have a narrow 60-day window to view the data and either verify or challenge it before it is posted on a publicly searchable database. Any conflicts not resolved within that window will appear on the database with a flag denoting that the information is still under dispute.
Inaccuracies in that data could make relationships between providers and industry seem unduly suspect, Ms. Daboul said. The survey showed 21 percent of physicians would sever their relationships with an industry partner that misreported financial information about them, not to mention potential fines for manufacturers and providers who fail to report conflicts of interest pertaining to physicians' investments and financial relationships.
Solutions. To address this, Ms. Daboul says her company offers technology solutions that enable manufacturers to share their version of financial data with the providers and physicians involved, who can then confirm or challenge the information long before the 60-day window begins to ensure what is reported to regulators and made public is accurate.
MMIS hosts the Physicians Professional Network, an online tool similar to LinkedIn that allows physicians free access to update and review relevant professional information, including industry data related to financial disclosure and licensing pulled from state and national databases. Using the PPN, providers and physicians can manually search to verify whether existing data is accurate, and even whether manufacturers have matched the correct National Provider Identifier number to the provider. When discrepancies are found, contact information on the site enables case-by-case conversations with industry to rectify the data.
Available for purchase, MMIS also offers a software suite called MediSpend that can track provider's data on transfers of value from industry, matching for compliance regulations by jurisdiction. That can be especially useful for teaching hospitals, Ms. Daboul says, that may manage 2,000 physicians who each may receive research money, samples, paid lunches, travel reimbursement and sponsorship or fees for speaking engagements from many different manufacturers, creating what can be a nightmare for CFOs and chief compliance officers attempting to keep tabs on reporting and potential conflicts of interest.
The version for industry will notify providers and physicians about information that has been logged, which allows them to double check that the information is in agreement with their own records. For example, if a manufacturer records that they paid the travel, speaking fees and meal expenses for a physician who presented at a conference, the physician may dispute that claim to say he or she paid for their own meals or hotel stay.
"We developed a system that will allow providers and industry to share data and to validate it before it is sent to CMS," Ms. Daboul says. "Providers can get information from any industry company and communicate back and forth to review or dispute to make sure the transactions are accurate," then authorized C-suite executives must sign off on the data before submission and upload to the CMS Web portal.
Benefits. That security has a three-fold benefit, she says: It ensures accurate data to protect physician reputations and industry from fines; it engages physicians, who can now be more aware of what will be reported when they accept industry offers for samples, funding or gifts; and it allows hospitals to more easily manage conflicts of interest by aggregating data directly from state, federal and industry databases.
"In the first few years, there's going to be a lot of pain [as the Sunshine Act is implemented] as changes in behavior begin to take shape," Ms. Daboul says. "And once the ecosystem starts to take shape, hospitals will better manage conflicts of interest, and [industry] will operate in good standing with ethics and compliance."
The healthcare "ecosystem," as Ms. Daboul describes it, has already seen changes begin in the symbiotic relationship between providers, industry and regulators. As that ecosystem falls back into balance, "we'll get rid of some bad behaviors and reward good behavior," which will ultimately drive costs down and enhance patient care. "And everybody thinks that's a good idea."
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As a result of this delay, CMS has pushed the deadline back one year. Now, industry manufacturers and group purchasing organizations must begin gathering records on "transfers of value" to physicians and providers starting Aug. 1, 2013, to be reported to CMS by March 31, 2014, along with information regarding physicians' ownership or investment interests.
In the dark. At the same time CMS' overdue final rule was issued, a study co-conducted by Portsmouth, N.H.-based healthcare software company MMIS showed that more than 50 percent of the 1,000 physician respondents, even with the 15-month delay, were unaware of the Sunshine Act, and 43 percent said the law's impact could affect their relationship with industry.
There are some valid reasons why some on the provider side of the equation are so uninformed on the matter, says MMIS President and CEO Michaeline Daboul. For one, opponents of the PPACA spent over a year trying to repeal it. Those efforts were foiled after the Supreme Court's 2012 decision to uphold nearly all of the law, but a final rule had still not been issued, stalling medical associations from pushing to prepare providers to comply with the act."Physicians are blaming their [medical] societies because they've done very little to educate their members, but all of these organizations were waiting on a final rule. There was nothing to educate them on otherwise," Ms. Daboul says. "Manufacturers did not feel it was their job at the time to educate their physician customers. Why would you want to tell your customers about something when you don't even know how it'll be implemented?
"Now, you're going to see a rhythmic increase in education from pharmaceutical companies that want to educate customers and hopefully from societies as well" she adds.
Reporting. After manufacturers and GPOs supply the financial data to CMS next March, providers and physicians will have a narrow 60-day window to view the data and either verify or challenge it before it is posted on a publicly searchable database. Any conflicts not resolved within that window will appear on the database with a flag denoting that the information is still under dispute.
Inaccuracies in that data could make relationships between providers and industry seem unduly suspect, Ms. Daboul said. The survey showed 21 percent of physicians would sever their relationships with an industry partner that misreported financial information about them, not to mention potential fines for manufacturers and providers who fail to report conflicts of interest pertaining to physicians' investments and financial relationships.
Solutions. To address this, Ms. Daboul says her company offers technology solutions that enable manufacturers to share their version of financial data with the providers and physicians involved, who can then confirm or challenge the information long before the 60-day window begins to ensure what is reported to regulators and made public is accurate.
MMIS hosts the Physicians Professional Network, an online tool similar to LinkedIn that allows physicians free access to update and review relevant professional information, including industry data related to financial disclosure and licensing pulled from state and national databases. Using the PPN, providers and physicians can manually search to verify whether existing data is accurate, and even whether manufacturers have matched the correct National Provider Identifier number to the provider. When discrepancies are found, contact information on the site enables case-by-case conversations with industry to rectify the data.
Available for purchase, MMIS also offers a software suite called MediSpend that can track provider's data on transfers of value from industry, matching for compliance regulations by jurisdiction. That can be especially useful for teaching hospitals, Ms. Daboul says, that may manage 2,000 physicians who each may receive research money, samples, paid lunches, travel reimbursement and sponsorship or fees for speaking engagements from many different manufacturers, creating what can be a nightmare for CFOs and chief compliance officers attempting to keep tabs on reporting and potential conflicts of interest.
The version for industry will notify providers and physicians about information that has been logged, which allows them to double check that the information is in agreement with their own records. For example, if a manufacturer records that they paid the travel, speaking fees and meal expenses for a physician who presented at a conference, the physician may dispute that claim to say he or she paid for their own meals or hotel stay.
"We developed a system that will allow providers and industry to share data and to validate it before it is sent to CMS," Ms. Daboul says. "Providers can get information from any industry company and communicate back and forth to review or dispute to make sure the transactions are accurate," then authorized C-suite executives must sign off on the data before submission and upload to the CMS Web portal.
Benefits. That security has a three-fold benefit, she says: It ensures accurate data to protect physician reputations and industry from fines; it engages physicians, who can now be more aware of what will be reported when they accept industry offers for samples, funding or gifts; and it allows hospitals to more easily manage conflicts of interest by aggregating data directly from state, federal and industry databases.
"In the first few years, there's going to be a lot of pain [as the Sunshine Act is implemented] as changes in behavior begin to take shape," Ms. Daboul says. "And once the ecosystem starts to take shape, hospitals will better manage conflicts of interest, and [industry] will operate in good standing with ethics and compliance."
The healthcare "ecosystem," as Ms. Daboul describes it, has already seen changes begin in the symbiotic relationship between providers, industry and regulators. As that ecosystem falls back into balance, "we'll get rid of some bad behaviors and reward good behavior," which will ultimately drive costs down and enhance patient care. "And everybody thinks that's a good idea."
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