Logo

Log In Sign Up |  An official publication of: American College of Emergency Physicians
Navigation
  • Home
  • Multimedia
    • Podcasts
    • Videos
  • Clinical
    • Airway Managment
    • Case Reports
    • Critical Care
    • Guidelines
    • Imaging & Ultrasound
    • Pain & Palliative Care
    • Pediatrics
    • Resuscitation
    • Trauma & Injury
  • Resource Centers
    • mTBI Resource Center
  • Career
    • Practice Management
      • Benchmarking
      • Reimbursement & Coding
      • Care Team
      • Legal
      • Operations
      • Quality & Safety
    • Awards
    • Certification
    • Compensation
    • Early Career
    • Education
    • Leadership
    • Profiles
    • Retirement
    • Work-Life Balance
  • Columns
    • ACEP4U
    • Airway
    • Benchmarking
    • Brief19
    • By the Numbers
    • Coding Wizard
    • EM Cases
    • End of the Rainbow
    • Equity Equation
    • FACEPs in the Crowd
    • Forensic Facts
    • From the College
    • Images in EM
    • Kids Korner
    • Medicolegal Mind
    • Opinion
      • Break Room
      • New Spin
      • Pro-Con
    • Pearls From EM Literature
    • Policy Rx
    • Practice Changers
    • Problem Solvers
    • Residency Spotlight
    • Resident Voice
    • Skeptics’ Guide to Emergency Medicine
    • Sound Advice
    • Special OPs
    • Toxicology Q&A
    • WorldTravelERs
  • Resources
    • ACEP.org
    • ACEP Knowledge Quiz
    • Issue Archives
    • CME Now
    • Annual Scientific Assembly
      • ACEP14
      • ACEP15
      • ACEP16
      • ACEP17
      • ACEP18
      • ACEP19
    • Annals of Emergency Medicine
    • JACEP Open
    • Emergency Medicine Foundation
  • About
    • Our Mission
    • Medical Editor in Chief
    • Editorial Advisory Board
    • Awards
    • Authors
    • Article Submission
    • Contact Us
    • Advertise
    • Subscribe
    • Privacy Policy
    • Copyright Information

EPs Say Sunshine Act Is Good in Theory, but…

By Andy Friedlander ACEP News Contributing Writer | on September 1, 2012 | 0 Comment
From the College
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
Print-Friendly Version

Tucked away deep within the 2,000-plus pages of the recently upheld Affordable Care Act is a tiny section of the law that could have a sizable impact on emergency physicians.

You Might Also Like
  • Reimbursement and coding updated for 2013
  • Investments in Health IT Will Happen in EDs
  • Nearly 500 EPs Visit Capitol Hill During Conference
Explore This Issue
ACEP News: Vol 31 – No 09 – September 2012

Section 6002 – a mere seven pages – details what is known as the Physician Payment Sunshine Act, a statute designed to give the public access to information regarding payments made to doctors from manufacturers of drugs, medical devices, and medical supplies through a searchable website.

And that intent is a good one, said ACEP President Dr. David Seaberg. But good intentions don’t guarantee good results.

“Surely the need for transparency is a good concept, especially if [a payment] is significant in value and could sway a physician’s judgment in terms of using drugs or devices,” Dr. Seaberg said. “That’s been shown in the past. But this rule really overreaches in terms of the bureaucracy it will create. It’s going to present a real problem for physicians.

“It’s a real bureaucratic overreach in what they’re trying to do. The basic concept is good, but this particular ‘sunshine rule’ is not where it should be.”

Exactly how the law will work is still something of a mystery. At press time, the Centers for Medicare and Medicaid Services (CMS) still had not released a final version, and it has postponed the collection of data until at least the beginning of 2013.

One thing that is known, however, is that the threshold for reporting payments or gifts is a mere $10 ($100 per payer during the calendar year).

As ridiculous as that sounds – “Two lattes and you’re up to 10 bucks,” ACEP Federal Affairs Director Barbara Tomar said – it’s written into the statute itself and is not open to interpretation by CMS.

And that, Dr. Seaberg and Ms. Tomar said, could quickly become problematic even though the physicians are not required to report anything themselves.

ACEP is trying to help members stay one step ahead by collecting their National Provider Identifier (NPI) numbers at this year’s Scientific Assembly held Oct. 8-11 in Denver. Providing NPIs to health care service providers, device manufacturers, and pharmaceutical companies puts the burden of making the reports on those companies giving the cash, stock, or in-kind items or services.

However, physicians also will need to keep their own detailed and accurate records in order to be able to dispute any erroneous reports. With such a low threshold, those records will be many.

“If somebody is reporting about your behavior, you’d better keep track of your own records, which imposes the same burden on both the reporters and the people being reported on,” Ms. Tomar said. “That’s part of the concern. Now you’ve got to keep all these records – any affiliation you had, any conference where you were a speaker, and so on. It just gets to be extremely onerous in terms of both content and time for record-keeping.”

That was one of the concerns expressed in a letter to CMS from a group of 50 national physician organizations and 43 state medical associations in response to the proposed rule. Among the other issues with the CMS proposal: the requirement that indirect payments must be reported even for CME in which the manufacturer has no control over content or speakers; the short 45-day window given to check the annual report and dispute any inaccuracies before the report is posted; and lack of a process for arbitrating disputes about the report’s accuracy.

That last item is a particular point of contention. In its proposal, CMS said the federal government should not “be actively involved in arbitrating disputes” between manufacturers and doctors, leaving them to resolve the issues themselves.

The physician groups called for CMS to establish an independent arbitrator or to use the total specified by the doctor on the website, with any disputed numbers flagged to notify the public. Those steps are important because, as the letter noted, while a few disputes with doctors won’t harm the manufacturer’s standing, “physicians may have their careers and professional reputations damaged as a result of one disputed report.”

The law does give doctors some breaks. For example, items such as product samples that are not intended to be sold and educational materials provided by manufacturers for patients do not have to be reported.

Overall, though, physicians will need to be far more aware than ever before of where the money and other items coming into their practice are actually coming from. And while that isn’t a bad idea, this particular way of putting it into practice may cause problems.

“I run a medical school, and we’ve changed our rules in terms of exposure of drug and device representatives to our residents and physicians,” Dr. Seaberg said. “They can’t accept any gifts over $50, and we have very strict rules now in terms of our graduate medical education and continuing medical education. And those are good. We support that. But the $10 threshold is way too low to have any meaning. The reporting has to be done within 45 days. The time period is short and it’s going to be a lot of paperwork, and frankly, there’s no oversight on that, either. Certainly, there are some good intentions here, but this goes way too far.”

What Is the Sunshine Act?

The Physician Payment Sunshine Act was signed into law in 2010 as part of the Affordable Care Act. But its genesis goes back to 2007 when an investigator for Sen. Chuck Grassley (R-Iowa) began looking into large undeclared payments from pharmaceutical companies to doctors for research, lectures, and consulting on new drugs.

That led to a bill, coauthored by Sen. Grassley and Sen. Herb Kohl (D-Wisc.), intended to let the public know as much as possible about the relationship between physicians and the drug and medical device industries to help consumers make informed decisions and to discourage physician conflicts of interest.

How that will be accomplished has not yet been decided. CMS released the proposed rules for implementation in December 2011 and solicited comments, but as of mid-July it had not handed down the final rules. In May, CMS postponed the beginning of data collection for the second time, until at least Jan. 1, 2013.

What is known are the provisions written into the statute:

  • Manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program must annually report payments (cash, in-kind items or services, stock or stock options) with a value of $10 or more, or a total of $100 or more from a manufacturer to a recipient over the course of a calendar year.
  • Manufacturers and group purchasing organizations must report physician ownership or investment interests.
  • Reportable payments include consulting fees, honoraria, gifts, entertainment, travel, food, royalty or license fees, charitable contributions, speaker fees, grants and compensation for research, education, ownership or investment interests, and serving as CME faculty or speaker.
  • Items exempt from reporting include product samples for patient use (not intended to be sold); educational materials intended for patient use; a loan of a device for up to 90 days; items or services provided under a warranty; discounts, including rebates; in-kind items used for charity care; and dividends or profits from investments in publicly traded securities or mutual funds.
  • Manufacturers can be fined up to $10,000 for each unreported payment, up to $150,000 each year.
  • The report will be released online on Sept. 30 each year. Recipients will have 45 days prior to that to review and submit corrections to the report.
  • Issues still up in the air, pending the final rules, include indirect payments, disputed reports, and explanatory information. For indirect payments, the statute specifies reporting for payments made to third parties at the request of or on behalf of a physician, but CMS’s proposed rule extends that to include instances in which the manufacturer learns the identity of the recipient after the payment. For disputed reports, neither the statute nor the proposed rule offers a process for arbitrating disputes. For explanatory information, the proposed rule includes a statement to be posted with the report explaining that payments do not indicate either legitimacy or wrongdoing.

Pages: 1 2 3 4 | Multi-Page

Topics: ACEPAmerican College of Emergency PhysiciansCMSCost of Health CareEmergency MedicineEmergency PhysicianHealth Care ReformHealth InsurancePolitics

Related

  • Navigating the Health Care System in Vietnam with CKD/ESRD

    September 23, 2025 - 0 Comment
  • EM Runs in the Family

    February 26, 2025 - 0 Comment
  • VACEP Legal Victory Illustrates Why the Prudent Layperson Standard Still Matters

    October 26, 2023 - 1 Comment

Current Issue

ACEP Now: November 2025

Download PDF

Read More

No Responses to “EPs Say Sunshine Act Is Good in Theory, but…”

Leave a Reply Cancel Reply

Your email address will not be published. Required fields are marked *


*
*


Wiley
  • Home
  • About Us
  • Contact Us
  • Privacy
  • Terms of Use
  • Advertise
  • Cookie Preferences
Copyright © 2025 by John Wiley & Sons, Inc. All rights reserved, including rights for text and data mining and training of artificial technologies or similar technologies. ISSN 2333-2603