CMA urges Congress to exempt medical textbooks and journals from Sunshine Act The California Medical Association (CMA) has joined the American Medical Association (AMA) and 70 other medical associations in support of H.R. 5539, which would exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. In a joint letter the organizations said that “passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by the Centers for Medicare and Medicaid Services (CMS) that have already chilled the dissemination of medical textbooks, peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent certified and/or accredited continuing medical education (CME).” H.R. 5539 would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive. The Sunshine Act was designed to promote transparency with regard to payments and other financial transfers of value between physicians and the pharmaceutical and medical product industries. Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. "This conclusion is inconsistent with the statutory language on its face, congressional intent and the reality of clinical practice where patients benefit directly from improved physician medical knowledge," states the letter. AMA and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for quality patient care. "Scientific peer-reviewed journal reprints, supplements and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care," the letter states. "Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients." H.R. 5539 would clarify that the Sunshine Act was designed to support the dissemination of this type of educational material. The letter also addresses CMS’ proposal to eliminate the CME exemption from the Act. This proposal will “erode support of independent medical education," the letter states. "There is widespread consensus that [this] will harm the dissemination of clinically relevant and critical medical knowledge that improves and enhances patient care. We strongly support the provisions in H.R. 5539, which would clarify that CME that meets the standard for independence must be exempt from Sunshine Act reporting." Click here to read the letter. November 5, 2014 General Physician Payment Sunshine Act 0 0 Comment Read More »
CMS launches Open Payments website The Centers for Medicare & Medicaid Services (CMS) today launched its Open Payments website, which allows consumers to see the financial relationships between drug and medical device manufacturers and physicians as reported under the Physician Payments Sunshine Act. The data published online contains 4.4 million payments made between August 1 and December 31, 2013, valued at nearly $3.5 billion and attributable to 546,000 individual physicians and almost 1,360 teaching hospitals. The database is divided into three categories, general payments, research payments and physicians ownership and investments. CMS says that these reports will be published annually and will include a full 12 months of payment data, beginning in June 2015. The Sunshine Act requires drug and medical device manufacturers and group purchasing organizations to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. According to CMS Administrator Marilyn Tavenner, the initial public posting of the data is only the first phase of the Open Payments program. “In coming weeks, we will be adding additional data and tools that will give consumers, researchers and others a detailed look into this industry and its financial arrangements,” she said. More than 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review payments attributed to them. Physicians were invited to review and dispute the records. During the review and dispute period, CMS identified payment records that had inconsistent physician information, such as National Provider Identifier (NPI) for one doctor and a license number for another. In cases where CMS was unable to match the physician information, the personally identifiable information has been suppressed temporarily in the record. Because of this, about 40 percent of the records published today are de-identified. This data will be fully identifiable in 2015 after the reporting entities submit corrected data, and physicians and teaching hospitals have a chance to review and if necessary dispute the data. In addition, data disputes that were not resolved by the end of the recent review period have not been published and will be updated at a later date. Physicians who weren’t able to review their data by the September 11 deadline for the initial public data release should do so now. Two-thirds of the data that has been released has yet to be verified by physicians and other covered recipients, according to the American Medical Association (AMA). Physicians have until December 31 to file disputes for any inaccurate information that should be corrected in the next data release. View instructions for doing so on the AMA’s Sunshine Act Web page. To view the Open Payments physician payment dataset, click here. October 1, 2014 General CMS, Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 0 Comment Read More »
September 10 is last day to dispute Sunshine Act data Wednesday, September 10 is the last day that physicians can review and if necessary dispute their financial interactions as reported under the Physician Payments Sunshine Act. The Sunshine Act is a provision of the Patient Protection and Affordable Care Act that requires drug and medical device manufacturers and group purchasing organizations (GPOs) to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database. This data will be made public via the Open Payments website beginning on September 30. Physicians should be aware that there is a two-step registration process for the Open Payments program. The first step requires physicians to register at the CMS Enterprise Portal, a step many physicians may have already completed as the gateway enables access to a number of other CMS programs. Step two is to register in CMS’ Open Payments system. Physicians and authorized representatives can submit questions to the CMS Help Desk at openpayments@cms.hhs.gov. Live Help Desk support is also available by calling (855) 326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. Central time, excluding Federal holidays. September 5, 2014 General Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 0 Comment Read More »
Huge chunk of data excluded from Open Payments website because of inaccuracies According to several news sources, the Centers for Medicare & Medicaid Services (CMS) has rejected about one-third of the "Open Payment" records submitted by manufacturers and group purchasing organizations (GPOs) because of "intermingled data." When the data goes public next month, those records will not be included. CMS says it will not publish the withheld data until June 2015, when it expects that manufacturers will have had time to correct the inaccuracies. Physician Payments Sunshine Act is a provision of the Patient Protection and Affordable Care Act. Drug and medical device manufacturers and GPOs are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database. This data will be made public via the "Open Payments" website beginning on September 30. The Open Payments system was taken offline a few weeks ago because of errors reported by physicians. Some of the physician website data was found to be “intermingled” between physicians with the same last names by manufacturers. After removing the offending records, CMS re-opened the website for physician review on August 15. To account for system down time, CMS is extending the time for physicians and teaching hospitals to review, and if necessary dispute, their records to September 8, 2014. The public website will be available on September 30, 2014. Physicians and authorized representatives can submit questions to the CMS Help Desk at openpayments@cms.hhs.gov. Live Help Desk support is also available by calling (855) 326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. Central time, excluding Federal holidays. More information on the Sunshine Act is available in the American Medical Association's online “Physician Sunshine Act Tool Kit,” which provides a variety of resources to help physicians navigate the Sunshine Act changes, including a free webinar, a list of important dates, answers to frequently asked questions, information about how to challenge incorrect reports and ways to be more transparent with patients about the physician's interactions with the pharmaceutical and medical device industries. August 21, 2014 Medi-Cal, Medicare CMS, Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 0 Comment Read More »
CMS temporarily takes Sunshine Act system offline The Centers for Medicare and Medicaid (CMS) announced yesterday that the verification system for financial interactions tracked under the Physician Payments Sunshine Act system has been taken offline temporarily because of physician complaints of inaccuracies. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database. CMS had opened the system for physicians to review and, if necessary, dispute the data reported by drug and device manufacturers on July 14, 2014, and the six week dispute period was supposed to remain open until August 27, 2014. According to CMS, for each day the Open Payments system is offline, CMS will extend the review and dispute deadline and the subsequent 15-day corrections period deadline accordingly. The California Medical Association will keep members up-to-date when the deadline dates are announced. CMS said physicians can still register with the CMS Enterprise Portal (the first step in signing up to review your data), despite the shutdown. They will not, however, be able to register for the Open Payments system (step two) until the system is brought back online. Physicians and authorized representatives can submit questions to the CMS Help Desk at openpayments@cms.hhs.gov. Live Help Desk support is also available by calling (855) 326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. Central time, excluding Federal holidays. More information on the Sunshine Act is available in the American Medical Association's online “Physician Sunshine Act Tool Kit,” which provides a variety of resources to help physicians navigate the Sunshine Act changes, including a free webinar, a list of important dates, answers to frequently asked questions, information about how to challenge incorrect reports and ways to be more transparent with patients about the physician's interactions with the pharmaceutical and medical device industries. August 8, 2014 Medi-Cal, Medicare CMS, Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 0 Comment Read More »
Physicians can review Sunshine Act data starting today The Centers for Medicare and Medicaid Services (CMS) announced that starting today physicians can complete part 2 of the registration process to review and dispute disclosures under the Physician Payments Sunshine Act. Physicians have 45 days to review and dispute their data (plus an additional 15 days to resolve disputes). The review and dispute process ends August 27, 2014. The information will be published publicly on September 30, 2014. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database. The two-step registration process first requires physicians to register at the CMS Enterprise Portal, a step many physicians may have already completed as the gateway enables access to a number of other CMS programs. Step two, which starts today, is to register with the CMS’ Open Payments system. The CMS offers a primer called Open Payments User Guide that includes how to register, review and use the dispute functionality on the website. More information is available from the American Medical Association's online “Physician Sunshine Act Tool Kit,” which provides a variety of resources to help physicians navigate the Sunshine Act changes, including a free webinar, a list of important dates, answers to frequently asked questions, information about how to challenge incorrect reports and ways to be more transparent with patients about the physician's interactions with the pharmaceutical and medical device industries. July 15, 2014 General Advocacy, Physician Payment Sunshine Act, Regulatory Advocacy, CMS 0 0 Comment Read More »
CMS proposes to end Sunshine Act CME exclusion The Centers for Medicare & Medicaid Services (CMS) has decided to eliminate the continuing medical education (CME) exclusion for the Physician Payments Sunshine Act. The news was included in the 2015 Medicare Physician Fee Schedule proposed rule. The Sunshine Act stems from a provision of the Patient Protection and Affordable Care Act. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database to be launched this fall. CMS had initially given sponsorships for CME a pass in the Sunshine Act because it believed adequate safeguards were already in place. However, experts argued that an exclusion could give drug and device companies a loophole for manufacturers to influence physicians without disclosure. CMS felt that the exclusions made the agency appear to be endorsing corporate sponsorships of CME. Physicians are reminded that they can now register to review and potentially dispute their data reported by manufacturers of drugs and medical devices under the Sunshine Act. According to CMS, physicians will be able to begin reviewing the disclosure data sometime in July. Physicians will then have 45 days to review and dispute their data (plus an additional 15 days to resolve disputes). For more information on the two-step registration process, click here. July 15, 2014 General Health Care Reform, Physician Payment Sunshine Act, Affordable Care Act 0 0 Comment Read More »
Sunshine Act dispute proposal threatens physicians' due process A newly proposed dispute resolution process for inaccurate Physician Payments Sunshine Act data would deny physicians their due process rights, the American Medical Association (AMA) and California Medical Association (CMA) told the Centers for Medicare and Medicaid Services (CMS) in comment letters this week. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database to be launched this fall. According to CMS, sometime in July physicians will be able to begin reviewing the data reported by drug and device manufacturers. Physicians will then have 45 days to review and dispute any inaccuracies and 15 days to resolve disputes. CMA and AMA have a number of concerns with the proposed dispute resolution process. Among them is the fact that manufacturers and group purchasing organizations (GPOs) are authorized to unilaterally dismiss disputes lodged by physicians without resolution of the dispute. Such unilateral dismissal is in direct violation of the final Sunshine Act rule. "The final rule does not authorize manufacturers or GPOs to dismiss disputes without both parties agreeing that the dispute is resolved," CMA President Richard Thorp, M.D., wrote in CMA's comments. According to the rule, if the parties are unable to resolve the dispute, the reported data is to be marked as disputed and flagged as such in the public database until resolution has been reached between the parties. However, allowing manufacturers/GPOs to unilaterally dismiss disputes without physicians’ agreement or consent would result in disputed data being posted publicly without any flag to indicate that it has been disputed, violating physicians' due process rights. CMA and AMA are worried this dispute resolution process could cause physicians economic and reputational harm, especially since the point of the Sunshine Act program is to give the public an accurate picture of the financial interactions between physicians and the drug industry. For more information, see CMA's letter to CMS on this issue. Physicians are also reminded that they can now begin the registration process, which is necessary in order for physicians to be able to access, review and potentially dispute data reported by drug and device manufacturers under the Sunshine Act. The two-step registration process first requires physicians to register at the CMS Enterprise Portal, a step many physicians may have already completed as the gateway enables access to a number of other CMS programs. Step two will be registration in CMS’ Open Payments system, which is set to begin in early July. More information on how to register will be available on the CMS website. Additional details are available in AMA's online “Physician Sunshine Act Tool Kit,” which provides a variety of resources to help physicians navigate the Sunshine Act changes, including a free webinar, a list of important dates, answers to frequently asked questions, information about how to challenge incorrect reports and suggestions for creating more transparency with patients about the physician's interactions with the pharmaceutical and medical device industries. June 18, 2014 General CMS, Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 0 Comment Read More »
Act now to protect yourself under the Physician Payment Sunshine Act By taking four easy steps now, you can make sure you're prepared when it's time to review your 2013 financial data before it's published online later this year. Under the Physician Payments Sunshine Act, drug and medical device manufacturers started tracking their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts – beginning Aug. 1, 2013. Any payments, ownership interests and other “transfers of value” will be reported to the Centers for Medicare & Medicaid Services (CMS) for publication in an online database to be launched in the fall of 2014. Here are four easy steps you can take now to support the accuracy of this data: 1. Make sure your disclosures are up to date. Financial and conflict-of-interest disclosures required by employers, advisory bodies and entities funding research should be updated regularly so it is consistent with the data that eventually will be publicly reported under the Sunshine Act. 2. Confirm that your National Provider Identifier (NPI) information is current. The information tied to your NPI, including your specialty, must be accurate to help ensure appropriate attribution of payments and other transfers of value that will be listed in CMS's online database. 3. Request ongoing notification from your industry contacts about the data they report to CMS. Ask your representatives at the manufacturers and group purchasing organizations with which you interact to give you an opportunity to review and correct information they intend to submit before they transmit it to CMS. The 2013 data is due March 31. 4. Track your payments and financial transfers. Download a free smartphone app to track reportable transfers. "Open Payments Mobile for Physicians" is available through the Apple Store and Google Play® Store. A number of security features protect the privacy of the data you capture, which will be stored on one device and cannot be backed up to a cloud or other devices. Also urge your industry contacts to use the app so you will be able to capture the information you need to ensure accurate reporting. Visit the AMA Sunshine Act physician toolkit to learn more about the law's timeline, the kinds of financial interactions that must be reported and the process to challenge false, inaccurate or misleading reports. January 6, 2014 General Physician Payment Sunshine Act, Legal Issues 0 0 Comment Read More »
