Subscribe   RSS Contact Us

Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization ... read more

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top ... read more

Industry Groups Oppose Oregon Bill Calling for Advertising Price Disclosure

March 9, 2017 – Four major advertising and media industry groups have issued a joint letter opposing an Oregon bill ... read more

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes ... read more

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February ... read more

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that ... read more

Previous Next

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for Healthcare Communication (CHC) recommended that the agency address key concerns before moving forward with planned FAQs regarding compliance with and implementation of the Sunshine Act final rules. CHC believes that its suggestions “will advance the goal of transparency while ensuring that the reporting process is as clear, consistent and efficient as possible for CMS, the industry and the public,” the comment states.

“Our member companies, which include publishers of medical news, information, research and scholarly data on the latest medical science intelligence, believe that important issues must be considered and clarified before the agency publishes FAQs on the Sunshine rules,” said Jack Angel, Executive Director, Coalition for Healthcare Communication Foundation. A number of these issues involve educational materials – textbooks, journal reprints, journal supplements and digitally delivered materials – which are prepared by professional publishers and sent to physicians but were not specifically mentioned in the Sunshine rule provisions, he said.

“If confusion or perceived reporting burdens cause reduced publication or restricted distribution of these valuable educational items, physicians will no longer receive crucial information and patient care will suffer,” Angel explained.

In its comments, the CHC discusses each type of educational material individually. Those comments are summarized here:

Textbooks

The CHC asserts that providing textbooks to physicians has been in practice for decades and  supports better care for patients. Additionally, textbooks are intended for professional, not personal use. Accordingly, textbooks should be excluded from the reporting requirement because these materials, like other educational materials, ensure “that clinicians are equipped with the most current medical information,” the CHC comment states. The CHC also asserts that the FDA regulates the distribution of medical education materials, which gives the Department of Health & Human Services “sufficient reason … to exempt them from reporting.”

Reprints

Reprints – copies of published articles from peer-reviewed journals – “reinforce the latest medical developments and facilitate the diffusion of medical innovation in the clinical setting,” according to the CHC. Deeming reprints – which likely cost well under $10 each – subject to Sunshine reporting would cause an untenable reporting burden on both covered entities and physicians, because covered entities would have to collect information on the identity of each physician who received a reprint and track when that physician reached the $10 threshold, and because physicians would have to log in each reprint they received from each covered entity to confirm that this tabulation is accurate.

“Instead, we recommend that [reprints] be treated like the distribution of pens and pencils,” which do not have to be tracked or reported, the comment states. “A contrary determination by CMS creates a real risk that physicians would choose to not receive reprints … a loss for healthcare providers and, ultimately, patients.”

Supplements

The CHC believes that supplements, which are special educational publications that publishers deem acceptable for mailing with the associated medical journal, would be subject to the same complications that reprints face, according to the comment, which also states that, “in the final analysis, any diminution of the availability of these educational materials would affect patient care.”

Digitally Delivered Educational Materials

Tracking this category, which covers educational materials (including reprints and supplements) that are delivered electronically, would be difficult to calculate as well, because neither the publisher nor the sponsor would have the complete or specific knowledge of the recipients. “This obvious reporting complication is a serious question in the administration of this regulation and needs to be addressed before data collection begins,” the CHC advised.

Angel underscored a point made in the CHC comment. “Receiving these materials provides no financial benefit to physicians. Making them reportable would impose great costs on industry, government and physicians, and have a negative effect on patient care,” he said. “We trust that these issues will be addressed by CMS appropriately.”