{"id":1301,"date":"2014-09-22T11:21:43","date_gmt":"2014-09-22T06:21:43","guid":{"rendered":"http:\/\/www.policymed.com\/two-bipartisan-efforts-in-congress-underscore-the-importance-of-up-to-date-medical-education-on-thursday-reps-michael-burg\/"},"modified":"2018-05-06T15:10:03","modified_gmt":"2018-05-06T10:10:03","slug":"two-bipartisan-efforts-in-congress-underscore-the-importance-of-up-to-date-medical-education-on-thursday-reps-michael-burg","status":"publish","type":"post","link":"https:\/\/www.policymed.com\/2014\/09\/two-bipartisan-efforts-in-congress-underscore-the-importance-of-up-to-date-medical-education-on-thursday-reps-michael-burg.html","title":{"rendered":"Physician Payments Sunshine Act: Bipartisan Members of Congress Introduce Bill to Exclude Educational Materials From Reporting, Including CME and Medical Texts"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Two bipartisan efforts in Congress underscore the importance of up-to-date medical education. On Thursday, Reps. <a href=\"http:\/\/burgess.house.gov\/\" target=\"_self\">Michael Burgess<\/a> (R-TX) and\u00a0<a href=\"http:\/\/pallone.house.gov\/\" target=\"_self\">Frank Pallone<\/a>\u00a0(D-NJ) <a href=\"http:\/\/www.policymed.com\/2014\/09\/in-a-notable-demonstration-of-bipartisanship-representatives-michael-burgess-r-tx-and-frank-pallone-d-nj-came-together.html\" target=\"_self\">sent a letter<\/a> to the Centers for Medicare and Medicaid Services (CMS), to voice concern about the agency’s plan to eliminate the continuing medical education (CME) exemption from the Sunshine Act. On Friday, Reps. Burgess and <a href=\"http:\/\/schwartz.house.gov\/\" target=\"_self\">Allyson Schwartz<\/a> (D-PA) introduced bipartisan legislation (<a href=\"https:\/\/www.govtrack.us\/congress\/bills\/113\/hr5539\">H.R. 5539<\/a>) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">The Sunshine Act <a href=\"http:\/\/www.ssa.gov\/OP_Home\/ssact\/title11\/1128G.htm\">lists as one of its exclusions<\/a> “educational materials that directly benefit patients or are intended for patient use,” which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have “downstream benefits” for patients as compared to “wall models and anatomical models,” which are intended to be used with the patient and are excluded from reporting requirements.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Recently the American Medical Association (AMA) and over 100 medical societies <a href=\"http:\/\/www.policymed.com\/2014\/08\/physician-payments-sunshine-act-medical-associations-and-societies-urge-cms-to-reconsider-cme-exempt.html\">wrote a letter to CMS<\/a> stating: \u201cThe Agency\u2019s decision to not cover these materials under the educational materials exclusion 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.\u201d The AMA and co-signing associations also urged CMS to reconsider removing the CME exemption from the current Final Rule. They voiced their concern that revoking the reporting exclusion for CME would have a \u201csignificant chilling effect\u201d on continuing education.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">H.R. 5539 would make the Sunshine Act consistent with these goals. Currently there are 12 exclusions from Sunshine reporting, including de minimis payments (under $10) and product samples. The statute would be updated as follows:<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\"><strong><em>Transparency Reports and Reporting of Physician Ownership or Investment Interests, <\/em><em><a href=\"http:\/\/www.ssa.gov\/OP_Home\/ssact\/title11\/1128G.htm\">Sec.\u00a01128G.\u00a0[42 U.S.C. 1320a-7h]<\/a><\/em><\/strong><\/span><\/p>\n<p style=\"text-align: left;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\"><strong><em>(B)<\/em><em>\u00a0<\/em><\/strong><em>Exclusions.\u2014<\/em><em>An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:<\/em><\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\"><strong><em>(iii)<\/em><em>\u00a0<\/em><\/strong><em>Educational materials that directly benefit patients or are intended for patient use<span style=\"color: #ff0000;\">, <\/span><\/em><em><span style=\"color: #ff0000;\">including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks<\/span>;<\/em><\/span><\/li>\n<li><span style=\"color: #ff0000; font-family: arial, helvetica, sans-serif; font-size: 12pt;\"><em><strong>(xiii)<\/strong> A transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.<\/em><\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\">The amendments would apply with respect to transfers of value made on or after the date of the enactment of this Act.\u00a0The bill has been referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif;\">View the bill here:\u00a0 <span class=\"asset asset-generic at-xid-6a00e5520572bb883401bb0789f325970d img-responsive\"><a href=\"http:\/\/policymed.typepad.com\/files\/h.-r.-5539.pdf\">Download H. R. 5539<\/a><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Two bipartisan efforts in Congress underscore the importance of up-to-date medical education. On Thursday, Reps. Michael Burgess (R-TX) and\u00a0Frank Pallone\u00a0(D-NJ) sent a letter to the Centers for Medicare and Medicaid Services (CMS), to voice concern about the agency’s plan to eliminate the continuing medical education (CME) exemption from the Sunshine Act. On Friday, Reps. Burgess […]<\/p>\n","protected":false},"author":1,"featured_media":8737,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33,51],"tags":[1101],"class_list":["post-1301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-open-payments","category-physician-payment-sunshine-act","tag-new"],"_links":{"self":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1301","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/comments?post=1301"}],"version-history":[{"count":1,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1301\/revisions"}],"predecessor-version":[{"id":8739,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1301\/revisions\/8739"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media\/8737"}],"wp:attachment":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media?parent=1301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/categories?post=1301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/tags?post=1301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}