The Centers for Medicare & Medicaid Services (CMS ) are issuing, on December 19, 2011, a long-awaited proposed rule designed to increase public awareness of financial relationships between drug and device manufacturers and certain health care providers. The CMS says that the resulting transparency should lead to improved, lower cost health care. Manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program will soon have to report to CMS any payments or other "transfers of value" they make to physicians and teaching hospitals, and manufacturers and group purchasing organizations (GPOs) will have to disclose ownership or investment interests by physicians or physicians' family members, and any transfers or payments of value to those physicians. The regulations implement ACA Sec. 6002, which added Sec. 1128G to the Social Security Act.
Information was originally supposed to be collected by manufacturers and GPOs by January 1, 2012, as required by the ACA, but the CMS is giving them a break and only requiring the gathering of information once the final regulations are published, since the proposed regulations were apparently issued later than originally anticipated. The data will probably have to be reported to the CMS by the end of March 2013.
Officials at the CMS seem quite excited about the potential advantages to health care consumers that the regulations will provide. According to Peter Budetti, M.D., CMS deputy administrator for Program Integrity. “Disclosure of these relationships will discourage the inappropriate influence on clinical decision-making that sometimes occurs while still allowing legitimate partnerships.” Budetti added that, "If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it," Under the ACA, violations of the reporting requirements will result in civil monetary penalties up to $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report.
It remains to be seen how much value this will really create for consumers, however. Applicable manufacturers' and group purchasing organizations' payment and ownership information is to be published by the CMS on a public website, and the regulations specify that the information provided must be downloadable, searchable, and easily aggregated. But, how many consumers really look at government websites, or any websites at all, before going to the doctor? A patient's choice of physician is arguably based more on whether or not the physician is covered under the patient's healthcare plan, on word-of-mouth, or on general availability and geographic location, than on any data to be found on websites so far.
The American Medical Association has a website with general physician information, including physician specialties and medical schools attended, and WebMD has a search tool allowing prospective patients to look for doctors by specialty and location, with some information provided about which doctors accept which plans. There's an assortment of sites out there with comments and ratings by patients of doctors they've seen, but how many people know about and use similar information already in existence on government websites? The Centers for Disease Control and Prevention (CDC), for example, has up-to-date data and statistics on a wide range of topics, such as nursing homes and fertility clinics, but many people may be unaware of the information they can obtain before making important medical decisions. Hopefully, the CMS won't end its efforts to increase transparency with the issuance of final regulations, expected sometime in 2012, and will, instead, work to make the general public aware of the new website. The information is expected to be made public by September 30, 2013. If you feel like adding your two cents' worth to the CMS, it is accepting comments until Feb. 17, 2012. The proposed rule is downloadable at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2011-32244.pdf .
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