Subscribe   RSS Contact Us

OPDP Issues Just Two Enforcement Letters in First Half of 2016

July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of ... read more

Gender and Healthcare Communications

By Nick Colucci, Publicis Health CEO July 21, 2016 — I was moved by a recent op-ed in The New ... read more

Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

July 15, 2016 – More than 100 medical associations, including the American Medical Association, signed a letter of support for ... read more

Pfizer Gets in Front of Opioid Marketing Issue

July 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer ... read more

Bill Gates Defends U.S. Drug Pricing System

July 1, 2016 – Amidst criticism over the high cost of drugs in this country, billionaire and philanthropist Bill Gates ... 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

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

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

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

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

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

Previous Next

Sunshine Act Final Rule Resets Clock on Annual Reporting of Payments to Physicians

Many Questions Still Unresolved

Feb. 4, 2013 – Although the final rule to implement the Sunshine provisions of the Affordable Care Act clarified several areas in question in the proposed rule, unresolved issues remain and the burden placed on industry to keep records and report on funds provided to physicians and teaching hospitals is significant, according to John Kamp, Executive Director, Coalition for Healthcare Communication.

The Sunshine final rule states that manufacturers must start collecting required data on Aug. 1 of this year and report it to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014.

“There are plusses and minuses to the final rule,” Kamp said. “It ends the uncertainty we’ve lived under since the proposed rule was issued in December 2011 and removes some of the meaningless requirements to report every bagel and cup of coffee offered at general meetings, but it also states that many routine products and services provided to physicians as part of reasonable and beneficial collaborative relationships are reportable,” he noted.

In the “pro” column for the final rule, which was released by the U.S. Department of Health & Human Services (HHS) on Feb. 1 and will be published Feb. 8 in the Federal Register, Kamp lists the following:

  1. Manyrules are explicit, clear, understandable, standardized, and actionable.
  2. The national Website reports will contain a section where clients can explain the purpose and context of the payments, thus enabling the public to understand their value.
  3. Clients and doctors have new, clear systems for reporting, reviewing and resolving disputes before the reports are public.
  4. Certified continuing medical education (CME) that follows national accreditation rules explicitly is exempted both for speaker fees and the value of attendance.
  5. The value of mass media supported by advertisers appears to be exempt.
  6. New meal reporting rules exempt coffee, snacks and buffets at widely attended events.

However, there are a corresponding number of items in the “con” column:

  1. The system is extremely burdensome to administer. (CMS conservatively estimates that it will cost $269 million the first year and $180 million per year thereafter.)
  2. Many politicians, reporters and others still are likely to consider every payment indicia of a conflict of interest and will criticize industry and doctors for simply collaborating.
  3. The rules appear to require reporting of all promotional education, even mandated education under REMS.
  4. Indirect payments by agencies and publishers to known physician recipients all must be reported.
  5. The value of all formal meals and entertainment at educational and other unpaid events offered to identifiable doctors must be reported.
  6. Disputes between doctors and clients must be resolved in a very short time span or they will be reported on the registry as unresolved.

It is the government’s position that while it understands that industry/provider collaboration “contributes to the design and delivery of life-saving drugs and devices … payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interest that may influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs,” the rule’s executive summary notes.

However, even though the rule states that “financial ties alone do not signify an inappropriate relationship,” industry has reason to be concerned that these ties will be viewed negatively, Kamp explained.

“With these rules in place, the press and some politicians must stop treating reported payments as indicators of some sort of scandal,” he said. “Collaboration between industry, physicians and academicians has led

to great medical breakthroughs in the past, so driving a wedge between these parties will hurt, not help patients. Transparency is good, but it must be clear to the public that a physician who collaborates with industry is not doing anything wrong.”

CMS will be accepting public comment on the final rule for 45 days.