​FOR IMMEDIATE RELEASE
Contact: Andrew Rosenberg, (202) 688-0223, arosenberg@thornrun.com
 
The CME Coalition applauds the Centers for Medicare and Medicaid Services (CMS) for their proposal to recognize accredited continuing medical education (CME) as a Clinical Practice Improvement Activity (CPIA) under the new Merit-Based Incentive Payment System (MIPS) — a physician reimbursement system created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). As detailed in the proposed rule (pg. 1042), CMS recommends that “completion of an accredited performance improving medical education program” be included under the list of CPIAs under MIPS — one of the key policy changes proposed for the Quality Payment Program Year 2.

​Under MACRA, physicians who do not participate in a qualifying alternative payment models (APM) will be subject to adjustments in their reimbursement under MIPS. MIPS is based on a 100-point score, with clinical practice improvement activities (CPIA) representing 15 percent of the score. The CME Coalition and other stakeholders have noted that CME should be included in the CPIA measurement category, as these courses are among the most important ways in which doctors seek to improve their understanding of new treatments and therapies, improve beneficiary outcomes, and ultimately, improve their practice as a whole.
 
“Participation in CME has been shown to result in meaningful, sustained clinical performance improvement,” said Andrew Rosenberg, Senior Advisor to the CME Coalition. “We applaud CMS for recognizing that including CME in these new value-based assessments will further incentivize physicians to participate in CME activities that improve their practice of medicine.”
 
The prospect of including CME under MIPS has previously been championed by over 300 stakeholders, including leading physician groups, CME providers, pharmaceutical companies, medical device manufacturers, and other prominent stakeholders. Supporters included the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the Council for Medical Specialty Societies (CMSS), and AdvaMed, among many others.

FOR IMMEDIATE RELEASE 
Contact: Andrew Rosenberg, (202) 247-6301
 
December 8, 2016 – On Tuesday, December 6, the Senate approved, by a vote of 94-5, a wide-ranging biomedical innovation bill called the 21st Century Cures Act (H.R. 34), which will provide about $4.8 billion over 10 years in medical research funding, make changes to the FDA’s review of medical products, and advance mental health reforms. The bill now heads to the desk of President Obama, who is expected to sign the measure into law. The bill passed the House of Representatives last week.
An earlier version of the bill included language, supported by the CME Coalition, that would have revised the Physician Payments Sunshine Act by declaring that certain transactions to doctors from pharmaceutical and medical device companies would no longer need to be reported through Open Payments as currently required. As a result, commercial supporter–provided peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks remain reportable to CMS, as before.
 
At the urging of Senator Charles Grassley (R-IA), the original architect of the Sunshine Act, other language creating a relatively broad exemption for the reporting of “non-promotional” education activities was also removed from the final bill before passage. For CME Coalition members, this decision was of low consequence, however, since the Sunshine Act already excludes reporting for education related payments where a commercial supporter provides a payment to a continuing education provider but “does not require, instruct, direct or otherwise cause (including, but not limited to, ‘encouraging’ or ‘suggesting’) the continuing education provider to provide payments or transfers of value to a specific or particular physician speaker or faculty.” Thus, most independent CME support for physicians was, and remains, already exempt from Open Payments reporting.
 
The current reporting exemption for certain CME payments is described in CMS sub-regulatory guidance FAQ 8165, which is provided below. The FAQ applies to all CME-related transfers of value in 2016.
 
 
FAQ 8165
 
Q:           “If an applicable manufacturer or group purchasing organization (GPO) provides a payment or transfer of value to a continuing education provider to support a continuing education program, but did not require, instruct, direct or otherwise cause (including, but not limited to, ‘encouraging’ or ‘suggesting’) the continuing education provider to provide payments or transfers of value to a specific or particular physician speaker or faculty, would the contribution be considered a reportable payment?
 
A:           No.  A payment or transfer of value as described above would not be subject to reporting under Open Payments for any covered recipient physician speakers or faculty.  As explained in the Calendar Year 2015 Physician Fee Schedule Final Rule, when an applicable manufacturer or GPO provides funding to a continuing education provider, but does not: (1) select or pay the covered recipient speaker directly, or (2) provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under § 403.904(i)(1) [revised as § 403.904(h)(i)].  This approach is consistent with our discussion in the preamble to the final rule, where we explained that if an applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule (79 Fed. Reg. 67759).  We continued by saying ‘[t]his is the case even if the applicable manufacturer or applicable GPO learns the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.’ (79 Fed. Reg. 67760).”
 
About the CME Coalition
 
The CME Coalition represents a broad collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. Graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning.
 
Contact: Andrew Rosenberg
Senior Advisor
CME Coalition
(202) 688-0223
arosenberg@thornrun.com
CME COALITION STATEMENT ON PASSAGE OF 21ST CENTURY CURES ACT, MAINTENANCE OF OPEN PAYMENTS REPORTING EXEMPTION FOR INDEPENDENT, INDIRECT CME PAYMENTS

In an overwhelming display of support for the value of continuing medical education (CME), over 300 stakeholders submitted comments to the Centers for Medicare and Medicaid Services (CMS) suggesting the agency should adopt new incentives to motivate physicians to participate in CME activities.

FOR IMMEDIATE RELEASE
Contact: Andrew Rosenberg, (202) 247-6301, arosenberg@thornrun.com
 
Several hundred leading healthcare practitioners, plus scores of stakeholder groups representing millions of the nation’s healthcare providers, submitted comments in support of encouraging the use of accredited CME to improve the quality of healthcare under the new Merit-Based Incentive Payment System (MIPS), according to analysis conducted by the CME Coalition. Over 300 endorsements for CME were submitted in response to CMS’ call for public comment on implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), including comments from leading physician groups, CME providers, and other stakeholders.
Under the new MACRA law, physicians who do not participate in a qualifying alternative payment models (APM) will be subject to adjustments under MIPS. MIPS is based on a 100-point score, with clinical practice improvement activities (CPIA) representing 15 percent of the score. In their numerous comments to CMS, stakeholders asserted that CME should be included in the CPIA measurement category, as these courses are among the most effective ways for doctors to improve their understanding of new treatments and therapies, improve patient outcomes, and ultimately, improve their practice as a whole.
 
“Participation in professional development activities like CME results in meaningful, sustained clinical performance improvement,” said Andrew Rosenberg, Senior Advisor to the CME Coalition. “This overwhelming demonstration of support for including CME in these new value-based assessments demonstrates the clear consensus of healthcare stakeholders that CME plays a pivotal role in improving the practice of medicine.CME COALITION COMMENTSThe CME Coalition submitted comments on June 27 addressing both the practical and technical implications of including CME in the CPIA measurement category under MIPS. “Consistent with the intent of [MACRA], and with focus on the ‘three aims,’ the National Quality Strategy (NQS) and the CMS Quality Strategy, CME encourages physicians to develop and maintain the knowledge, skills, and practice performance that leads to improved performance with optimal patient outcomes,” the comments state. “Simply put, without translating the new payment system into meaningful actions for physicians, the promise of MACRA will never be fully achieved.”
 
The Coalition’s comments go on to detail the need for physicians to participate in CME to remain informed of the evolving landscape of treatment options and quality measurements. “Without this professional development, the measurement of adherence to quality metrics and use of health information technology are insufficient to produce clinical performance improvement,” the Coalition explains. “Patients will continue to need health care professionals that engage in lifelong learning, assessment, and improvement in practice, so it is important these activities be recognized and rewarded in value-based payment programs promulgated by CMS and private payers.”
COMMENTS FROM CME ACCREDITING BODIES​Accreditation Council for Continuing Medical Education
“Specifically, the ACCME requests that: (1) CMS recognize relevant performance and quality improvement accredited continuing medical education (CME) as a clinical practice improvement activity within MIPS. (2) CMS designate ACCME’s Program and Activity Reporting System (PARS) as a reporting mechanism for clinical practice improvement activities.”
 
Accreditation Council for Pharmacy Education (ACPE)
“We recommend that CMS explicitly acknowledge and provide credit for certain CE (as well as CME) activities, provided by a nationally-recognized accreditor, as clinical practice improvement activities within the Merit-Based Incentive Payment System. In specific, we seek explicit credit for certain defined CE activities in two of the CMS designated clinical practice improvement activities, namely: (1) Accredited CE activities that involve assessment and improvement of patient outcomes or care quality, as demonstrated by clinical data or patient experience of care data, such as Quality Improvement CE. (2) Accredited CE that teaches the principles of quality improvement and the basic tenets of MACRA implementation, including application of the ‘three aims,’ the NQS, and the CMS Quality Strategy, with these goals being incorporated into practice.”PROVIDER GROUP COMMENTSAmerican Medical Association
“First, we would like CMS to add accredited continuing medical education (CME) and board-certification related activities to the list of CPIAs. These activities take up considerable time for physicians but ensure patient care is of the highest quality and reflects the latest medical knowledge and innovations. While 45 some proposed CPIA activities could be satisfied through CME, we believe a more explicit recognition would help physicians understand whether all CME will count under the CPIA component of MIPS.”
 
American Academy of Family Physicians
“Aligning with CPIAs is performance improvement CME, which supports health care transformation by encouraging clinicians to reflect on current practice and engage them to make changes in their practice that ultimately improves the care that is delivered. There are now multiple examples in the literature that proves the value of performance improvement CME as a vehicle for not only promoting change, but also embedding that change into a practices’ workflow so that observed improvement is sustained in the long term. Fundamentally, the objectives of CPIAs and performance improvement CME are congruent with the strategic goals of the Administration.”
 
Council for Medical Specialty Societies
“[W]e strongly urge CMS to specifically recognize accredited continuing medical education (CME) as another means to satisfy CPIA requirements. CME encourages physicians to develop and maintain the knowledge, skills, and practice performance that leads to improved performance with optimal patient outcomes. Practice improvement multi-dimensional interventions, including participation in professional development activities like CME, are a necessary component of the change process that results in meaningful, sustained clinical performance improvement. Without this professional development, the measurement of adherence to quality metrics and use of health information technology are insufficient to produce clinical performance improvement.”
 
Alliance for Continuing Education in the Health Professions
“I am the 2016 President of the Alliance for Continuing Medical Education, the largest national organization of educational professionals dedicated to the continuing education needs of physicians and other healthcare professionals. Like so many other respondents to this call for comments, we know from many years of evidence-based research that CME (continuing medical education) that is designed to involve clinicians in efforts to make changes to the systems of care and the behaviors that are represented in those systems does lead to significant clinical changes that benefit patients.”
MORE ORGANIZATIONAL COMMENTSAlong with over 300 individuals who submitted comments on CME and MIPS, the following organizations also submitted comments on CMS’ proposal:
​

• Advanced Dermatology Associates – Pennsylvania
• American Academy of Allergy Asthma and Immunology
• American Academy of Neurology
• American Academy of Physical Medicine and Rehabilitation
• American Association of Neurological Surgeons
• American Board of Medical Specialties
• American College of Physicians
• American College of Rheumatology
• American Medical Informatics Association
• American Osteopathic Association
• American Society for Radiation Oncology
• American Society of Gastrointestinal Endoscopy
• American Society of Nephrology
• American Urogynecologic Society
• American Urological Society
• California Academy of Family Physicians
• Endocrine Society
• Medical Society of New Jersey
• Rockpointe Corporation
• Society for Academic CME
• Society of Nuclear Medicine and Molecular Imaging
• Society of Vascular Surgery
• South Carolina Medical Association
• Trauma Care Association of America
• Washington State Medical Society

Anti-industry activists continue to mislead the public about the rules and regulations governing accredited continuing medical education (CME) in order to promote their “pharma-scare” narrative. On the contrary, accredited CME is the trusted mainstay of post-graduate physician learning and provides the primary means by which innovation and discovery are brought to the patient bedside. 
 
FOR IMMEDIATE RELEASE 
Contact: Andrew Rosenberg, (202) 247-6301

December 17, 2015 – Today, the CME Coalition responded to an opinion piece written by noted critics of continuing medical education (CME) affiliated with the group, Pharmed Out, in the Journal of Medical Ethics.
​
According to CME Coalition Senior Advisor Andrew Rosenberg, “It is becoming tiresome to have to respond to this continuous barrage of misinformation and outright untruths from PharmedOut, but we feel compelled to again correct the record.”
“First, PharmedOut is 100% wrong when they claim that ACCME, the Accreditation Council for Continuing Medical Education, does not require the reporting of exhibit income. It patently does, and I would be happy to point them to the ACCME Annual Report, which clearly lists exhibit income as one of their reported categories.” Rosenberg continued, “And with respect to their accusations regarding the fact that in-kind costs such as equipment rental and the use of facilities are not reported to the ACCME, the reason is simple and straightforward: the determination was rationally made that it is impossible to accurately calculate the ‘value’ of allowing a CME program to borrow equipment or lab space for the purpose of educating doctors, and that in any case, there is no financial benefit of this support to any doctor.”

Further, the ACCME SCS already require accredited providers to implement and adopt robust conflict of interest policies and procedures prior to engaging a presenter or faculty (SCS 2), and the SCS mandate that individual presenters at CME programs to disclose potential conflicts of interest (SCS 6). 

“Finally, the PharmedOut writers dishonestly declare that ACCME’s own materials state that ‘drug and device companies are allowed to control the content of accredited CME activities’ while conveniently failing to include the next sentence of the guidance that states: “In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.”

Exciting changes in medicine are happening everyday with increasing frequency. Patients and society demand that our physicians receive information as quickly as possible, and that updates in treatment, diagnosis, and prevention are disseminated to physicians, and to the patient, as soon as practically possible. Without CME, this all falls apart.
​
And while we always welcome honest debate about the rules governing independent CME, there is no room in the discussion for PharmedOut’s relentless, helplessly biased campaign of misinformation.

About the CME Coalition

The CME Coalition represents a broad collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. Graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning.
 
Contact: 
Andrew Rosenberg
(202) 247-6301
arosenberg@thornrun.com

In response to an overwhelming outpouring of stakeholder comments, CMS redefined its Open Payment reporting rules to specifically exclude the vast majority of CME payments, including speaker-related payments and tuition support for attendees, so long as they follow CME guidelines and are, therefore, not directed by a commercial supporter. Although CMS deleted the section of a previous rule that defined a limited CME reporting exclusion for CME payments for certain accredited programs, the new rule sets reasonable criteria for determining which CME-related payments need not be reported.

FOR IMMEDIATE RELEASE
Contact: Andrew Rosenberg, (202) 247-6301, arosenberg@thornrun.com

On October 31st, CMS announced that the section of last year’s Open Payments rule that created a special CME exemption was eliminated. In its place, CMS provided redefined and pre-existing reporting rules that specifically exclude CME payments, including speaker-related payments and tuition support for attendees, so long as they are not directed by a commercial supporter and otherwise do not meet the definition of an indirect payment under§403.904(i)(1). 

The CME Coalition applauds this new approach.

Specifically, CMS clarifies that where "an applicable manufacturer or applicable GPO provides funding to support a continuing education event [and] does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment … to a covered recipient, the [commercial supporter] is not required to report the payment.” (Final Rule at page 595) Importantly, CMS specifically declares under the Final Rule that such indirect CME-supporting transfers of value are not reportable, even if the commercial supporter subsequently discovers the identity of the covered recipient “because the payment or other transfer of value did not meet the definition of an indirect payment.”

“As a practical matter, because the standards for commercial support inherent in most accredited CME already prohibit commercial supporters from paying speakers directly, suggesting speakers (e.g., providing a list), or otherwise controlling the nature or content of the educational program, there will not be any necessity to report CME payments under the Sunshine Act for most accredited CME programs,” stated CME Coalition Senior Advisor Andrew Rosenberg. “Therefore the CME Coalition applauds CMS for clarifying these important rules in such a manner.”

Furthermore, CMS addressed another important concern of CMS stakeholders by making it clear that physician attendees of CME programs need not be reported to Open Payments for the value of their educational experience, so long as the commercial supporter does not "instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee.” (Final Rule at pages 595-596). The CME Coalition looks forward to working with CMS to assist the agency in drafting sub-regulatory guidance regarding tuition fees provided to physician attendees, which the agency expects not to be reported.

These clarifications by CMS address the chief concerns of the CME Coalition and over 98% of the commenters to the public record who called on the Agency to maintain a strong CME exemption to the reporting requirements.

About the CME Coalition

The CME Coalition’s 30+ member organizations represent a broad collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually.
Graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning.