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Recent Study Saying One Free Meal Affects Prescribing Practices Is Cherry-picking Data

June 27, 2016 –  A recent study published in JAMA Internal Medicine got broad media coverage last week largely because ... read more

CEOs to Coalition’s Rising Leaders: Engage in Political Process, Keep Learning

June 17, 2016 – In order to stay ahead of change, further their careers and forward the positive message of ... read more

Washington Health Policy Focus Is on Drug Innovation, Reform and Pricing, Rawson Says

June 13, 2016 – Before and after the 2016 elections, Washington health policy will remain fixed on improving the path ... read more

Davidson Sums Up Past and Current State of DTC Ad Restrictions, Ad Tax Deduction

June 7, 2016 – The Advertising Coalition (TAC) Executive Director Jim Davidson gave industry’s next generation a comprehensive overview of ... read more

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First ... read more

Congressman Jenkins to Coalition’s Rising Leaders: You Have the Power to Influence Lawmakers

May 24, 2016 – At a recent Coalition for Healthcare Communication Rising Leaders Conference, keynote speaker Rep. Evan Jenkins (R-W. ... read more

Coalition Rising Leaders Conference: Industry Advocacy Will Help Shape Healthcare’s Political Landscape

May 17, 2016 — Healthcare policy improvements are underway in Washington, and industry advocacy makes a difference—that was the recurring message ... read more

The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation

May 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on ... read more

Drug Companies Should Be Able to Share Information with Payers

May 2, 2016 – In order to make reasonable coverage decisions about new medicines, payers need access to information from ... read more

Commissioner of Food and Drugs Califf Lists Advertising, Labeling Among Priorities

April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner ... read more

FTC to Pharma on Native Advertising: Proceed with Caution

April 18, 2016 – Although native advertising – online content that appears similar to the news, feature articles or other ... read more

American College of Physicians Calls DTC Advertising “Inappropriate”

April 4, 2016 – The hits just keep coming against direct-to-consumer (DTC) drug advertising, with the latest criticisms being made ... read more

Coalition to Host ‘Rising Leaders’ Conference in May

March 28, 2016 – To further educate and integrate the up-and-coming leaders in the healthcare communication industry, the Coalition for ... read more

Comments on FDA’s DTC Advertising Survey Due by April 29

March 21, 2016 – Industry members planning to send comments to the FDA on the “National Direct-to-consumer Advertising Survey” that ... read more

NYTimes: Ban on Drug Ads Would Also Eliminate Ad Benefits

March 14, 2016 — The American Medical Association (AMA) as well as Rep. Rosa DeLauro (D-Conn.) and Sen. Al Franken ... read more

Drug Innovation Success Story: President Carter and Keytruda

March 10, 2016 — The article below, which covers drug pricing concerns in the news and the success of Merck’s ... read more

Sen. Franken Introduces Legislation to End Drug Advertising Tax Breaks

March 4, 2016 – Yesterday Sen. Al Franken (D-Minn.) introduced legislation that would end the tax deduction that drug companies ... read more

Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts ... read more

Best Offense Is a Good Defense When Discussing Drug Pricing

Feb. 29, 2016 – When faced with criticism of drug pricing, industry members need to be able to defend drug ... read more

DeLauro’s House Bill to Restrict DTC Advertising Likely Would Violate First Amendment

Feb. 18, 2016 – A bill introduced in the House last week by Rep. Rosa DeLauro (D-Conn.) — the Responsibility ... read more

CDER’s Woodcock Says FDA Is Meeting GDUFA Challenges at House Pricing Hearing

Feb. 8, 2016 – At last week’s House hearing on drug pricing a bipartisan group of U.S. Congressional members, the ... read more

Industry More Than Ready for FDA Off-label Communications Guidance

Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in ... read more

OPDP Enforcement Letter Cites Hospira for Omission of Risk in YouTube Video

Jan. 25, 2016 – The Office of Prescription Drug Promotion (OPDP) kicked off 2016 with a Jan. 14 Untitled Letter ... read more

Industry Prepares for DTC Battle

Jan. 12, 2016 – As criticism of prescription drug direct-to-consumer (DTC) advertising continues to be levied by presidential hopefuls and ... read more

Are DTC Ads Being Mischaracterized?

Dec. 28, 2015 – The supposed ill effects of direct-to-consumer (DTC) advertising are being levied without much evidence, according to ... read more

Pacira Prevails in Exparel Settlement with FDA

Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a ... read more

Save the Date: PhRMA’s Lori Reilly to Speak to Coalition on Feb. 16

Dec. 14, 2015 – Lori Reilly, executive vice president, Policy and Research, at the Pharmaceutical Research and Manufacturers of America ... read more

Coalition Arms Industry with Tool Kit to Defend DTC Advertising

Dec. 14, 2015 – With medical marketing being targeted by politicians and the media as one cause of high drug ... read more

NBER: DTC Ads Increase Treatment of the Undertreated and Undiagnosed, Improve Drug Adherence

Dec. 7, 2015 – While direct-to-consumer (DTC) advertising increases the number of drug prescriptions, it also boosts the number of ... read more

AMA Calls for DTC Advertising Ban

Nov. 17, 2015 — The American Medical Association (AMA) announced today that it would support an advertising ban on direct-to-consumer ... read more

Rocky Political Road Ahead for Pharma Industry

Nov. 16, 2015 – From tax inversions to the proposal to reduce ad tax deductions for marketing to being named ... read more

PhRMA Puts Drug Costs in Perspective as Pricing Scrutiny Increases

Nov. 9, 2015 – Congress, federal agencies and the media continue to turn up the heat on their examination of ... read more

Kaiser Poll: DTC Ads Have High Profile, But Mixed Reviews

Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its ... read more

CHC DC Meeting: Prescription Drugs Are Cost Savers, Not Cost Drivers

Oct. 26, 2015 – There is no question that prescription drugs have a cost to patients and payers, but that ... read more

FDA Study of DTC Ads Reaches Critical Mass

Oct. 20, 2015 – The FDA’s announcement last week that it was accepting comments on two new studies of direct-to-consumer ... read more

Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine Reporting

Oct. 12, 2015 – A bill introduced in the Senate last week by Sen. Charles Grassley (R-Iowa) and Sen. Richard ... read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it ... read more

Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and ... read more

CMPI: Value of Prescription Drugs Is Underestimated

Sept. 21, 2015 – Despite widespread reports about the soaring prices of prescription drugs and calls by the federal government ... read more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA ... read more

Comment Period for Brief Summary Revised Guidance Extended to Oct. 5 Under Second Revision

Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ... read more

Pitts Calls Higher Drug Approval Rate a Sign of Regulatory Progress

Aug. 24, 2015 – Although some may call the FDA to task for approving more new drugs than they have ... read more

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Aug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to ... read more

Kamp on Presidential Politics: They Matter to Medical Marketers

Aug. 17, 2015 – In an Aug. 11 column posted on the PharmaLive website, Coalition for Healthcare Communication Executive Director ... read more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin ... read more

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... read more

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CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance by the Centers for Medicare & Medicaid Services (CMS) as well as the issuance of three FAQs for CME reporting, and a report by the Accreditation Council for Continuing Medical Education (ACCME) which states that industry spending on CME is up after several years – reflect both the ongoing burden that the Sunshine Act regulations have placed on CME and the industry’s support for this important educational tool.

“These recent CME developments are important to industry because they clarify the CMS position on CME and also show that CME continues to be supported and valued by the healthcare community,” said Coalition for Healthcare Communication Executive Director John Kamp.

The changes published by CMS are not new, according to an article published today in Policy and Medicine, but CMS recently announced them in order to “correct what many felt was a misinterpretation of the Sunshine Act Final Rule regarding CME payments,” the article in Policy and Medicine states. The three new CME FAQs also are described (for a full analysis, see:

The ACCME issued its 2014 annual report earlier this month ( The organization’s report includes data from more than 1,900 accredited CME providers.

“CME providers offer a range of online and face-to-face educational activities, giving healthcare professionals access to efficient, relevant, and engaging opportunities for lifelong learning,” according to ACCME President and CEO Graham McMahon. In a message from McMahon in the report, he states that accredited CME “aims at changing more than knowledge; CME providers design and evaluate activities for meaningful change in skills, performance, and patient health outcomes.”

The ACCME report summary offers “key takeaways” which include the following:

  • The ACCME community is a “robust, stable” community, with 1,908 accredited CME providers that offered 147,000 educational activities in 2014.
  • CME providers offer a diverse range of activity types.
  • Accredited CME providers “are successfully achieving the ACCME’s expectations” to design programs that “create change” in competence and patient outcomes.
  • Investment in CME continues to occur, from a variety of sources.

Further, the report states that drug and device firms contributed $675.9 million in direct monetary support, a figure that is up slightly after seven years of decline.

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in a federal courtroom in New York related to off-label communication by Amarin – “portend advances not seen in decades” in the communication policy arena, according to Coalition for Healthcare Communication Executive Director John Kamp, who authored an article posted today on the Medical Marketing and Media (MM&M) Website. In the MM&M article, Kamp outlines the three provisions in the 21st Century Cures Act that will most affect medical marketers and highlights recent developments in the court case.

To read the full article, go to:

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, by an overwhelming majority of 344-77. The legislation, which includes three provisions that are important to healthcare marketers, now heads to the Senate.

The bill’s authors, House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-Colo.), Health Subcommittee Chairman Joe Pitts (R-Pa.), full committee Ranking Member Frank Pallone, Jr., (D-N.J.), and Health Subcommittee Ranking Member Gene Green (D-Texas) commented: “Today, we took a big leap on the path to cures, but we still have much work left to do. The 344 votes today should be a springboard for action. On to the Senate.”

In the House, the bill had 230 co-sponsors and the support of more than 700 groups, including the Coalition for Healthcare Communication, which has praised the legislation’s inclusion of provisions that would:  (1) exempt CME, reprints and reference texts from reporting under the Sunshine Act; (2) expand authority for biopharmaceutical companies to provide economic information to payers; and (3) direct the FDA to provide further guidance on off-label marketing.

“The Coalition for Healthcare Communication is pleased that so many members of our industry, the public and Congress have embraced this legislation, which will forward innovation and improve the care of patients across the country,” said Coalition Executive Director John Kamp. “It’s nice to see legislation this important move forward.”

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong support for H.R. 293, a bill designed to clarify that specific transfers of value under the Sunshine Act are not reportable. In a May 29 letter (2015 Burgess Sunshine Letter), the groups, representing both national specialty societies and state medical societies, echo many of the same concerns they raised with the Centers for Medicare & Medicaid Services (CMS) last July: to exempt educational materials, such as medical textbooks and peer-reviewed medical reprints and journals, from Sunshine reporting, and allow an exemption for independent continuing medical education (CME).

“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by [CMS] that have already chilled the dissemination” of these materials, “and to avert a similar negative impact on access to independent certified and/or accredited [CME],” the letter states. “H.R. 293 would ensure the 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,” it continues.

Specifically, the organizations’ letter reiterates to Burgess, who co-sponsored H.R. 293 with Peter DeFazio (D-OR), that the Sunshine Act established an exclusion from the reporting requirements for educational materials “that directly benefit patients or are intended for patient use” and that CMS incorrectly concluded that textbooks and reprints do not meet that requirement. “This conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients directly benefit from improved physician medical knowledge,” according to the letter.

“In stating that peer-reviewed educational materials ‘represent the gold standard in evidence-based medical knowledge,’ these well-known medical organizations, including the American Medical Association, focus on the fact that better informed physicians lead to better treatment for patients,” said Coalition for Healthcare Communication Executive Director John Kamp. “Doctors know that access to evidence-based medicine is the key to ensuring that patients have access to the best care. H.R. 293 will restore the intent of Congress,” he said.

The letter concludes by stating that “The Sunshine Act was not passed to limit or construct additional barriers to the dissemination of new medical knowledge that improves patient health outcomes.”

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine Act, at least one transparency advocate said at a recent hearing that “patients shouldn’t see physicians who see drug representatives.” Speaking at a National Coalition on Health Care ( hearing held at the U.S. Capitol Visitor Center in Washington, D.C., on Jan. 14, Dr. Adriane Fugh-Berman, pharmacology professor at the Georgetown University Medical Center, also indicated that patients should be wary of nearly any role that pharmaceutical companies play in the healthcare arena.

“Pharma is getting very involved in a very scary way in disease management,” Fugh-Berman said. “You should be very afraid of this.” She also said that “pharma companies will always be targeting whoever is affecting market share,” whether they be physicians, payers or patients, and suggested that the Sunshine Act reporting requirements be extended to cover transfers of value to advanced practice nurses and physician assistants.

Fugh-Berman, who is a participant in Pharmed Out (, a Georgetown University Medical Center project designed to document and disseminate information about how pharmaceutical companies influence prescribing, remarked that pharma companies are working behind the scenes to boost their marketing results. “About four out of 10 physicians in the U.S. now do not see drug reps,” she said. As a result, “pharmaceutical companies will figure out who the social contacts are,” such as who “their kids play basketball with” or their “spouse’s best friend and target those people in order to try and get a marketing message to the targeted physician.” Further, she added that pharmaceutical companies have “invented” conditions, such as social anxiety disorder and GERD, “out of whole cloth.”

“Clearly, the enemies of pharma marketing are focused and vocal, as this Hill meeting report indicates,” said Coalition for Healthcare Communication Executive Director John Kamp. “Nothing better illustrates the need for the Coalition and its allies to stay engaged in Washington and continue to tell the positive story of industry communication saving lives and increasing the quality of lives while contributing to effective and efficient healthcare in America.”

Other speakers at the event were strongly in favor of the Sunshine Act reporting requirements. Dr. William Jordan, president-elect, National Physicians Alliance (, concluded his presentation by saying that he is hopeful that the Sunshine Act Open Payments system will continue to improve because “[i]t acts as a shaming tool, for better or worse.”

“Unfortunately the anti-pharma posture of several panelists evidently clouded their ability to accept or appreciate any benefit, educational or otherwise, to physician interaction with industry,” Adam Huftalen, Government Affairs, Reed Elsevier, told the CHC.

The panel’s lack of balance was noted by an audience member, who prefaced her question to the group by stating, “I’m beginning to think it would be good to have somebody else here to represent another point of view, because it seems like everyone [on the panel] is on the same page.”

During the Q&A portion of the hearing, Dr. Will Shaffer, medical director of the American Academy of Orthopaedic Surgeons, said he did not believe that the intent of the Sunshine law was to discourage association-based continuing medical education (CME), especially the type of “blinded CME” done at the association level, but that the current regulatory scenario seemed murky at best. “It is clear that association CME is considered either ‘legal but immoral’ or ‘legal or disdainful’ behavior,” he told the panel.

Rodney Whitlock, health policy director, Office of Sen. Charles Grassley (R-Iowa), responded to Shaffer that “in the case of CME, it is an ongoing conversation, warranting further conversation, but we are not leading the charge, particularly because of the complexity and nature [of CME].” He added that in the case of journal articles, physicians have the choice to not take them, take them and report them, or buy them on their own, all of which “are legitimate choices.” Whitlock also distanced himself Dr. Jordan’s position, noting that he rejected associating the view that these activities were in any way immoral or disdainful with his remarks or his boss’ work.

This practice is “totally legal and we are not rushing to attach judgment here,” Whitlock asserted. “A provider who wants to become more educated is okay, and no provider should be uncomfortable talking about” that transfer of value with patients, he added.

However, reports about the Sunshine Act data accessible in the Open Payments database from organizations like ProPublica and Pharmed Out appear to find fault with merely the existence of a relationship between doctors and drug companies.

“There is a long-standing concern by both doctors and industry that the Sunshine Act database may be used out of context by the press and others to negatively characterize perfectly reasonable and appropriate relationships between doctors and industry,” Kamp said. “The Coalition for Healthcare Communication will continue to fight against the erroneous perception that companies should not help to educate providers about treatment options for their patients.”

[Editor’s note: The full hearing is available at: The CHC suggests reviewing the Q&A portion of the hearing, starting @ 52:00.]

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on how companies should report payments that are used to fund continuing medical education (CME) programs has caused a bit of controversy, because it appears to be inconsistent with the agency’s own final regulations.

CMS has offered differing accounts of whether industry payments to CME providers – which run educational programs for physicians and pay physician speakers to participate in these events – are reportable. Clearly they are indirect payments, but CMS has waffled on when these indirect payments are reportable under the Physician Payments Sunshine Act/Open Payments program. As recently as Oct. 31, CMS issued revisions to the final rule that seemed to exclude certified CME speaker and attendee costs from reporting under the Sunshine Act.

In the Dec. 17 Wall Street Journal’s Pharmalot column written by Ed Silverman, Coalition for Healthcare Communication Executive Director John Kamp commented on the apparent reversal of this exclusion in the subregulatory guidance. “This appears to be one of the biggest flip flops I have ever seen,” Kamp told Pharmalot.

A CMS official is quoted in the article as saying that the agency has not changed its position and “believes ‘we’ve been entirely consistent’ in attempting to craft a final rule.” The good news is that the rule does not go into effect until 2016, so there is still time to get additional clarification. CME Coalition Senior Advisor Andrew Rosenberg states in a press release that “this creates the need for further clarification, which we will be seeking on behalf of our members.”

“This is anything but over,” Kamp said in the Pharmalot article. “We need to see if CMS just made a mistake or actually means what they issued. If they do mean it, I think there will be a court challenge or more likely some kind of legislation on Capitol Hill to reverse it.”

To read the full Pharmalot article, go to:

For additional coverage, also see Policy and Medicine’s article at:

CMS Reinterprets Sunshine Act Final Rule to Exclude Certified CME Costs from Reporting

Nov. 3, 2014 – The certified continuing medical educations (CME) community got a “treat” on Oct. 31, when the Centers for Medicare & Medicaid Services (CMS) issued revisions to the Physician Payments Sunshine Act that exclude certified CME speaker and attendee costs from reporting under the Sunshine Act.

Although CMS maintained that it had eliminated the CME exemption from Sunshine Act reporting rules, it also reinterpreted the rule to exempt certified CME providers from reporting payments to physician speakers and attendees at CME events, as long as the industry sponsor “does not require, instruct, direct, or otherwise cause” the payment to go to specific recipients, according to the fine print of the CMS Report and Order.

The logic behind this move is that such payments are not payments at all under the statute and this not reportable, according to Coalition for Healthcare Communication Executive Director John Kamp. “Thus, even if the grantor becomes ‘aware’ of the names of physician speakers or attendees, these are not reportable,” Kamp said.

CMS’ shift in this area follows an overwhelming majority of comments sent to CMS in September, which stated that the agency should either retain the CME exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Act (

According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article,

“Because the new CMS rule mirrors the standard of the ACCME and other accreditors for speaker payments, the newly announced CMS ruling essentially eliminates Sunshine reporting for CME events,” Kamp noted. “This decision likely will lead to more robust participation of physicians in certified CME events sponsored by industry.”

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by last week’s deadline stated that the agency should either retain the continuing medical education (CME) exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Physician Payment Sunshine Act.

According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article,

Possible Consequences of Eliminating CME Exemption

  • “Absent that specific exemption, attendees may be less willing to participate in those programs – even if the industry support for the program was completely independent and conflict-free – if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them.” (American Academy of Family Physicians)
  • “The proposed rule will link applicable manufacturers and speakers at independent CME in a manner that is antithetical to the notion of ‘independent’ CME and inconsistent with current guidance from FDA and accrediting organizations regarding the conduct of these programs. PhRMA is concerned that this proposal will harm independent CME programs by diminishing speaker and attendee participation at independent CME and by chilling manufacturer funding of these programs.” (Pharmaceutical Research and Manufacturers of America)
  • “Pfizer believes that CMS’ proposal will allow reported CME events to be misperceived as subject to industry control, when in fact none existed. … CMS’ alternatives also are not viable options.” (Pfizer)
  • “The unintended consequence … may dissuade participation in valuable CME activities and hinder the adoption and spread of important medical education intended to keep the public safe and enable optimal care and outcomes for patients.” (American College of Radiology)
  • “Physicians may decline CME faculty positions to avoid the misperception that they are receiving payments or transfers of value from manufacturers for influential purposes, when in fact these funds are determined without knowing the identity of the CME faculty, and without influence on the faculty or content of the program.” (Biotechnology Industry Organization)
  • “We are concerned that removing the exemption for CME from the text of the rule itself will create legal ambiguity as to whether such payments continue to be reportable, leaving manufacturers to rely on CMS’s statements in the preamble to the proposed rule, which carry less weight than the regulation itself under the law.” (Medical Device Manufacturers Association)
  • “The creation of new products will produce enduring social gains only if physicians are properly trained and educated about these advances. … Patients count on doctors to be up to date with these latest medical breakthroughs, and CME provides doctors with that knowledge.” (CME Coalition)

Redundancy of Provisions

  • “The current proposal by CMS to delete 42 CFR 403.904(g) … is seriously flawed. While there may be overlap between the two sections, they are not the same. … Removing Section 403.904(g) in favor of Section 403.904(i)(1) would be replacing the more certain provision with a more problematic and confusing one.” (American College of Radiology)
  • “We are concerned, however, that the indirect payment exclusion, as reflected in the regulatory text itself, is not, in fact, redundant with the CME-specific exclusion that CMS proposes to eliminate. Reliance on the indirect payments exclusion could therefore achieve the opposite result from what CMS intends, as it likely would require the reporting of most applicable manufacturer provision of funds to a CME provider.” (Biotechnology Industry Organization)

“Awareness” Standard

  • “It would be difficult for funders to claim that they are not ‘willfully ignorant’ about this information during or after the program. Indeed, this information is often freely available well before a CME or CE activity takes place through marketing materials for the activity.” (The Alliance for Continuing Education in the Health Professions)
  • “Physician faculty and attendees at accredited CME events are not reportable under the Open Payments program because of the firewall created through their strict adherence to the Standards for Commercial Support (SCS), not by the timing of when an applicable manufacturer may discover their identity.” (American College of Radiology)
  • “It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. … Therefore, establishing a policy whereby an arbitrary determination of the presence of a relationship based on the timing of learning of the faculty names is unworkable – the names of faculty at CME programming cannot and should not be hidden.” (American Academy of Pediatrics)
  • “AdvaMed member companies have advised that they often come to ‘know’ the identity of a faculty speaker at a program for which they have provided independent support … For example, the manufacturer may have booth space at the same conference, may schedule its own meetings before or after such conferences, or may be part of a presentation panel at the conference. Importantly, in these situations, a company does not know how much – if any – of the grant funding it paid to a third-party conference provider is in turn paid by the third-party conference provider to a physician faculty member.” (AdvaMed)

Recommendation Highlights

  • “To avoid the appearance of endorsing particular accrediting organizations, CMS could eliminate the requirement in [403.904(g)(1)(i)] that the accredited CME program be accredited by one of the listed organizations and, instead, require that the CME event be recognized by a state or the federal government as accredited or certified.” (Pharmaceutical Research and Manufacturers of America)
  • “We are proposing that CMS maintain an explicit definition in the Final Rule of ‘accredited or certified CME’ in the definition section of the Final Rule. … Second, understanding that the ‘awareness’ standard becomes nearly impossible for accredited CME speakers, faculty and attendees to comply with, instead of removing Section 403.904(g), we would recommend revising it…” (CME Coalition)
  • “We urge CME to stay its hand at this early stage in the implementation of Open Payments and to avoid hastily discarding the CME exemption, which was carefully considered before it was enacted and which remains critical to the education of our health care providers and consequently to the health of the public.” (American Academy of Family Physicians)

For additional coverage of comments submitted to CMS regarding the proposed CME exemption elimination, go to Policy and Medicine at

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be published July 11, the Centers for Medicare & Medicaid Services (CMS) proposed the elimination of the exemption from Sunshine Act reporting for continuing medical education (CME) supported by industry.

“When so many other issues need to be addressed – especially the needed exemption from Sunshine Act reporting for reference texts and journal reprints – it’s startling and disappointing that the CMS would chose to reopen the CME exemption,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s high time that CMS limit and simplify these rules, not extend and complicate them.”

Specifically, CMS proposes deleting the CME Sunshine Act exemption in its entirety. “Eliminating the exemption for payments to speakers at certain accredited or certifying [CME] events will create a more consistent reporting requirement,” CMS states in a July 3 fact sheet about the proposed changes.

CMS explains in the proposed rule that the changes are in response to stakeholder comments raising concerns “that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not.”

Moreover, the proposal would further complicate the enforcement of the statutory exclusion of “indirect” payments that appears unaffected by the new proposal.  According to CMS, the indirect payment “ provision excludes indirect payments or other transfers of value where the applicable manufacturer is ‘unaware’ of, that is, ‘does not know,’ the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.”

Under this provision, if an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.

In addition to eliminating the CME exemption, CMS also is proposing three related changes:

  • Deleting the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply” which is already defined in regulation.
  • Requiring the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
  • Requiring applicable manufacturers to report stocks, stock options or any other ownership interest as distinct categories, to enable CMS to collect more specific data regarding the forms of payment made by applicable manufacturers.

CMS will be accepting comments on its July 11 proposed rule until Sept. 2

The Coalition for Healthcare Communication is working with industry and lobbying partners, including the CME Coalition and the Alliance for CME in the Health Professions, to develop a sharp and effective defense of the CME exemption. All members interested in being part of these discussions should contact John Kamp at:

CME Coalition Calls Out JAMA Report Inaccuracies

Dec. 20, 2013 – CME Coalition Senior Advisor Andrew Rosenberg stated that a Dec. 18 Journal of the American Medical Association (JAMA) report on the financial relationships between “medical communication companies” and industry contains “many inaccuracies and examples of unfounded innuendo,” according to a recent article in Policy and Medicine.

The article states that JAMA, which did not make its report available to the public but did issue an editorial on the report, “erroneously interchanges medical communications companies with medical education companies,” uses inaccurate data, misunderstands and/or distorts a 2007 Senate Finance Committee Report, criticizes the data policy of medical education companies despite using the same policy, and employs “blatant hypocrisy.”

JAMA should recognize that not only has the Sunshine Act become the law of the land, but significant strides have been made to ensure that medical professionals know who helps fund CME and other educational programs,” said Coalition for Healthcare Communication Executive Director John Kamp. “PhRMA, AdvaMed, and BIO have all developed significant self-regulatory codes. Moreover, these organizations and communication companies have worked diligently with the ACCME to strengthen the standards for commercial support, increased transparency, and management of potential bias in education,” he continued.“JAMA should know that many of the practices directly or indirectly criticized, such as meeting in Maui, and med ed companies also doing promotion, are practices that have been abandoned for years,” according to Kamp. Indeed, “JAMA mixes up medical education companies with medical communication companies as if they were the same, a distinction that any learned journal should well understand,” he said.

To read the full Policy and Medicine article, go to:

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