Shire Corporate Integrity Agreement: New Payment Disclosure Requirements
We recently wrote about Shire’s $56.5 million settlement to resolve False Claims Act allegations involving the company’s ADHD drugs Adderall XR and Vyvanse. Shire agreed to a Corporate Integrity Agreement (CIA) with HHS-OIG in exchange for avoiding exclusion from participation in Medicare, Medicaid, or other Federal health care programs.
Shire’s agreement became effective September 15; view it here.
Shire’s CIA has similar requirements and structure to previous agreements, with some noteworthy changes, especially in the physician payment disclosure category. We have compared Shire’s CIA to the Agreements entered ...
Source: Policy and Medicine - October 20, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
American Hospital Association Examines Value of CME: Champions Integrating Education With Quality Improvement; Performance-Based Programs
The American Hospital Association’s Physician Leadership Forum examined the value of CME to hospitals as a "strategic resource for physician-hospital alignment." The report provides recommendations for how to improve the value of CME, including greater use of performance-based CME, more streamlined accreditation standards, broader sharing of best practices, increased communication between CME departments and senior leadership, and greater involvement of physician leaders as champions in CME.
View the full report: Continuing Medical Education as a Strategic Resource
According to AHA, in 2013, hospitals accounted fo...
Source: Policy and Medicine - October 7, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
A Little Sunshine Peeking Through the Clouds? - the Sunshine Act is Finally Implemented, Sort of
"Conflicts of interest" is probably the most frequently used Health Care Renewal tag. We believe conflicts of interest are a major causes of health care dysfunction. Therefore, I felt that one of the truly reformative aspects of the US Accountable Care Act (ACA, "Obamacare") could be the "Sunshine Act," a provision championed by Iowa Senator Grassley (R) and his staff investigator, Paul Thacker, that would require public reporting of most financial interactions among health care corporations and health care professionals and hospitals. The roll-out of Sunshine Act implementation occurred this week, and not unex...
Source: Health Care Renewal - October 3, 2014 Category: Health Management Tags: biotechnology conflicts of interest DHHS health care reform medical devices pharmaceuticals Source Type: blogs
Linking Domestic Violence and Chronic Disease: An Issue Missing from the Headlines
With domestic violence getting attention lately due to the Ray Rice video and the newly crowned Miss America Kira Kazantsev’s domestic violence platform, the Society for Women’s Health Research believes it is important to highlight an important subject missing from the headlines.
There has been radio silence about the acute and chronic health conditions that affect women who suffer from this abusive behavior. Black eyes, bruises and broken bones are all what we expect to hear from victims who experience violence at the hand of a loved one.
There has been little to no attention, however, given to other health conditions...
Source: Disruptive Women in Health Care - October 3, 2014 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Chronic Conditions Policy Women's Health Source Type: blogs
Physician Payments Sunshine Act: Bipartisan Congressional Leaders Urge CMS to Keep the CME Exclusion
In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX), Vice Chairman and Frank Pallone (D-NJ), Ranking Minority Member of the Health subcommittee of the House Energy and Commerce Committee, came together to encourage the Centers for Medicare and Medicaid Services (CMS) to exempt from Sunshine Act reporting requirements payments related to the support of certified continuing medical education (CME). The lawmakers stated that this would “ensure robust physician participation in this important activity without concern for Sunshine Act reporting rules.”
View the letter here:&#...
Source: Policy and Medicine - September 22, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: Bipartisan Members of Congress Introduce Bill to Exclude Educational Materials From Reporting, Including CME and Medical Texts
Two bipartisan efforts in Congress underscore the importance of up-to-date medical education. On Thursday, Reps. Michael Burgess (R-TX) and Frank Pallone (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 and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act rep...
Source: Policy and Medicine - September 22, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: National Health Council Urges CMS To Include Indirect Payment Exemption for Voluntary Health Agencies
Discussions with VHAs have revealed that the sunshine rules are complex to comply with as each applicable manufacturer has their own interpretation of the rule. Because these transactions are hands off from the manufacturers, the leadership and others have a hard time understanding why CMS feels it is necessary to collect this information.
Related StoriesPhysician Payments Sunshine Act: Physician Review Period Marred By Technical Difficulties, Missing Payments, and UncertaintyCMS Addresses Open Payments Data Submission ProblemsPhysician Payments Sunshine Act: Organizations Res...
Source: Policy and Medicine - September 15, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
International CME: European Accreditation Council of Continuing Medical Education Conference Highlights New Accreditation Requirements
The Journal of European Continuing Medical Education recently published a recap of this year’s “Union Européenne des Médecins Spécialistes” (UEMS) Conference on continuing medical education (CME) in Europe. We have provided highlights from the conference report, written by Julie Simper, below.
As a background, the UEMS established the European Accreditation Council for Continuing Medical Education (EACCME) in 2000 to ensure international mutual recognition of quality assessments of CME activities throughout Europe. As we have seen in the United States, CME has evolved in many ways since 2000. The Journal notes tha...
Source: Policy and Medicine - September 12, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: Organizations Respond to CMS
September 2nd marked the last day for comments on CMS’ proposed rule to eliminate the accredited continuing medical education (CME) exemption from Sunshine Act reporting. In an overwhelming display of support for the exemption, over 800 comments were submitted encouraging the agency to either maintain or expand the current exclusion.
-Total comments supporting maintenance or expansion of the CME exemption: 820
-Total comments supporting elimination of the CME exemption: approximately 20
-Percentage of comments supporting the CME exemption: 98%
We have followed this issue closely, and recentl...
Source: Policy and Medicine - September 8, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: CME Coalition Urges CMS To Reconsider Eliminating the CME Exemption
The CME Coalition has submitted their comment voicing serious concerns over CMS’s proposal to eliminate the CME exemption from Sunshine Act reporting. The Coalition notes that, as written, the proposed changes will have a detrimental effect on the professional training of medical professionals, and ultimately, on patient outcomes. The comment proposes a manner of determining bona fide accredited CME programs that are deserving of exemption from the Sunshine Act reporting rules.
CME Coalition Analysis of the Proposed Rule
In its submission, the Coalition embraces the preamble of CMS’s proposed rule, that the criteria fo...
Source: Policy and Medicine - September 3, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: ACCME Responds to CMS' Proposal to Remove CME Exemption
The Accreditation Council for Continuing Medical Education (ACCME) has sent a letter to CMS urging them to reconsider their proposal to remove Section 403.904(g)(1), the CME exemption, from the Sunshine Act. The ACCME joins a long list of commenters who believe that indirect commercial support to an accredited CME vendor, which may be used to pay physician speaker fees, should be exempt from reporting requirements. The ACCME comment holds added importance because their Standards of Commercial Support is the model policy for ensuring complete separation between promotion and education. Furthermore, ACCME’s enforcement pow...
Source: Policy and Medicine - August 25, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Council of Medical Specialty Societies Petitions CMS To Maintain CME Exemption
The Council of Medical Specialty Societies (CMSS), which represents forty-one societies with an aggregate membership of 750,000 U.S. physicians, recently submitted their comments to CMS regarding the proposal to eliminate the CME exemption from the Final Rule implementing the Sunshine Act. They ask CMS to keep Section 403.904(g)(1) as written for a number of important reasons.
1. The distinction must be made and maintained between accredited and certified CME, offered by accredited CME providers offering credit certified by the CME credit systems in medicine, contrasted with the promotional education of physicians,...
Source: Policy and Medicine - August 21, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payment Sunshine Act: AAFP Raises Concerns with CMS Proposal to Remove Accredited CME Exclusion
The American Academy of Family Physicians (AAFP) "strongly disagrees" with the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Sunshine Act. AAFP, which represents 115,900 family physicians and medical students across the country, wrote to CMS to outline their concerns that the proposal would create "an inadvertent barrier to the development and delivery of high quality certified or accredited CME with the final result of negatively affecting care provided to patients."
AAFP notes that "CMS recognized that industry support for accredited or c...
Source: Policy and Medicine - August 7, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: Over 100 Medical Associations and Societies Urge CMS To Reconsider CME Exemption and Open Payments Timeline
Medial associations and specialty societies have been understandably frustrated with the way the Physician Payments Sunshine Act has rolled out so far.
Yesterday, over 100 medical societies including the American Medical Assocation--49 state medical societies and 64 medical specality societies--sent a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS) asking for redress over three problematic issues: (1) the expansion of reporting requirements for educational activities, (2) Open Payments’ condensed timeframe for physician registration, and (3) the complicated r...
Source: Policy and Medicine - August 6, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Physician Payments Sunshine Act: Proposed CME Change: “Axing Sunshine Exclusion Has Wide-Ranging Consequences”
This reporting exclusion is detailed specifically in the current rule and does not seem to be accounted for in the second Sunshine Act provision CMS says will now cover indirect payments if the CME exclusion is dropped. CMS also does not make any mention of attendees and the materials they receive at CME events.
"I can't imagine CMS meant to get rid of that reporting exclusion, but they don't address it," the industry official says. "There is a big concern that physicians will be less inclined to attend CME events if their names and the educational materials they receive will be reported on a public website, a...
Source: Policy and Medicine - August 5, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
