presents presents Physician Payments Under PPACA's Sunshine Provisions and State Law Provisions and State Law Meeting the Challenges of Healthcare Reform's Reporting Requirements A Live 90-Minute Teleconference/Webinar with Interactive Q&A Q& Today's panel features: Donald H. Romano, Partner, Moderator, Arent Fox , Washington, D.C. Ann DesRuisseaux, Principal, GlobalComplianceStrategies.com , Dallas K thl Kathleen McDermott, Partner, Morgan, Lewis & Bockius LLP , Washington, D.C. M D tt P t M L i & B ki LLP W hi t D C Wednesday, October 6, 2010 The conference begins at: The conference begins at: 1 pm Eastern 12 pm Central 11 am Mountain 10 10 am Pacific P ifi You can access the audio portion of the conference on the telephone or by using your computer's speakers. Please refer to the dial in/ log in instructions emailed to registrants.
For CLE purposes, please let us know how many people are listening at your location by y • closing the notification box • and typing in the chat box your • and typing in the chat box your company name and the number of attendees. attendees • Then click the blue icon beside the box to send to send. F For live event only. li t l
• If you are listening via your computer If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. lit f i t t ti • If the sound quality is not satisfactory and you are listening via your computer speakers, li t i i t k please dial 1-866-871-8924 and enter your PIN when prompted. Otherwise, please send e p o p ed O e se, p ease se d us a chat or e-mail sound@straffordpub.com immediately so we can address the problem. • If you dialed in and have any difficulties during the call, press *0 for assistance.
Stafford’s Physician Payments Under PPACA’s Sunshine Provisions and State Law Meeting the Challenges of Healthcare Reform’s Reporting Requirements October 6, 2010 1:00 – 2:30 pm EST
Premise Financial conflict of interest in the health industry Financial conflict of interest in the health industry collaborations, arrangements and services must be managed or eliminated. g Transparency and disclosure of financial interests are key ingredients to conflict of interest y g management. Trend from self-regulation (Codes of Ethics) to g ( ) government regulations (U.S. Sunshine Provisions) have become a global trend. -5-
Discussion Agenda g Transparency Trends Self-Regulation via Codes of Ethics v. Mandated Legal Requirements Protection of confidential commercial Information and data privacy? privacy? Impact of anti-bribery enforcement on transparency and conflict of interest management. Strategy to reconcile corporate policies, multiple codes of ethics, mandated transparency terms with technology capability, audit process, Information retrieval, and reporting. -6-
U.S. Sunshine Provisions - History In 2007, Physician Payment Sunshine Act of 2007 (S.2029) , y y ( ) introduced by Senators Grassley and Kohl. Senators Grassley and Kohl conducted investigations that revealed potential conflicts of interest in the relationships p p between physicians and drug and device manufacturers. In 2009, the Senators reintroduced the Physician Payment Sunshine Act (S.301). ( ) The proposed Act was incorporated into both the Senate health reform bill (America’s Healthy Future Act of 2009, S.1796, section 4101) and the House-passed health reform , ) p bill (Affordable Health Care for America Act, HR.3962, section 1451). -7-
U.S. Sunshine Provisions – Reporting requirement Reporting requirement Who must report: “Applicable Manufacturer” Who must report: Applicable Manufacturer Manufacturer of a covered drug, device, biological, or medical supply, that is operating in the US “Covered” means for which payment is available under Medicare, Medicaid, SCHIP (or a waiver of such a plan). Where to Report: Secretary of HHS Where to Report: Secretary of HHS When to Report: First report due March 31, 2013 for transactions in 2012! First report due March 31, 2013 for transactions in 2012! 90 th day of each calendar year thereafter. Secretary to establish procedures for reporting by 10/11. Watch for opportunity to comment to HHS rule-making on transparency implementation. -8-
U.S. Sunshine Provisions – Reporting Requirement Reporting Requirement What to Report: Payments or other transfer of value made in What to Report: Payments or other transfer of value made in preceding year to “covered recipients.” Covered Recipients: Covered Physicians defined under SSA (except employee of manu.) and teaching hospitals. Includes entity/individual at request or on behalf of covered recipient recipient Except if made indirectly through a third, if the applicable manufacturer is unaware of the identity of the covered y recipient. -9-
U.S. Sunshine Provisions- Reportable Information Reportable Information Name and business address of the covered recipient (and specialty and NPI if th NPI, if the covered recipient is a physician); d i i t i h i i ) Amount of the payment or other transfer of value; Dates on which the payment or other transfer of value was provided; Description of the form of the payment or other transfer of value , indicated as: Cash or cash equivalent In kind items or ser ices In kind items or services Stock, a stock option, or other ownership interest, dividend, profit, or other return on investment Any other form of payment or other transfer of value ; Any other form of payment or other transfer of value ; 6. Name of covered drug, device, biological, or medical supply, if applicable; and 7. Any other information as the Secretary may determine appropriate. -10-
U.S. Sunshine Provisions- Core Reportable Activities Core Reportable Activities Consulting fees Consulting fees Compensation for services other than consulting Honoraria Gift Entertainment Food Travel Education Research Charitable contribution Royalty or license Current or prospective ownership or investment interest Current or prospective ownership or investment interest Compensation for serving as a faculty or as a speaker for a CME program Grant Any other payment or transfer of value. List is not exclusive. -11-
U.S. Sunshine Provisions- Reporting Exclusions Reporting Exclusions A transfer of anything the value of which is less than $10, unless the aggregate amount to a covered recipient during a calendar year t t t d i i t d i l d exceeds $100. For calendar years after 2012, the dollar amounts shall be increased by the same percentage increase in the consumer price index. Product samples that are not intended to be sold and are intended for patient use. Educational materials that directly benefit patients or are intended for patient use patient use. The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient . Items or services provided under a contractual warranty, including the replacement, if the terms of the warranty are set forth in the agreement. A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a recipient is a patient and not acting in the professional capacity of a covered recipient . -12-
U.S. Sunshine Provisions- Reporting Exclusions Reporting Exclusions Discounts (including rebates). In-kind items used for the provision of charity care. A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund. In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan. In the case of a covered recipient who is a licensed non-medical In the case of a covered recipient who is a licensed non medical professional, a transfer of anything of value to the covered recipient if the transfer is payment solely for the non-medical professional services of such licensed non-medical professional. In the case of a covered recipient who is a physician a transfer of In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative proceeding. -13-
Samples p Although there is an exclusion from the reporting Although there is an exclusion from the reporting requirements for samples, there is a separate reporting requirement under Sec. 6004. p g q Requires manufacturers and authorized distributors of record to submit to the Secretary by April 1 of y y p each year (beginning with 2012) a report of the identity and quantity of drug samples requested and distributed, aggregated by the practitioner making the request. -14-
Recommend
More recommend
