SIDE-BY-SIDE OF THE PHYSICIAN PAYMENTS SUNSHINE ACT

Transcription

1 Provision Amends Implementation Date Who must disclose? Reporting Frequency Grassley 2008 bill Grassley/Kohl bill Patient Protection and revised (S.301), 111 th Affordable Care Act (MAL08221) Congress (PL ), section Title XI of the Social Security Act (Finance, E&C, W&M jurisdiction) Title XI of the Social Security Act (Finance, E&C, W&M jurisdiction) 6002 Title XI of the Social Security Act (Finance, E&C, W&M jurisdiction) Notes March 31, 2011 March 31, 2011 March 31, 2013 Key change: Shifted the implementation date by 2 years All manufacturers of drugs, devices or medical supplies. Quarterly with respect to previous calendar year. All manufacturers and marketers of drugs, devices or medical supplies. All manufacturers of a drug, device, biological, or medical supplies Manufacturer is defined as entity involved in the production, preparation, propagation, compounding, or conversion or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply). Key change: Altered the definition of manufacturer to include marketers. Also clarified that biologics are covered. Annually Annually Key change: Annual reports compared to quarterly reports from previous drafts. Prepared by Hart Health Strategies, Updated 3/30/10 Page 1

2 Payments or transfers of value to whom? What must be disclosed? What must be disclosed? (cont.) To a physician or To a physician, physician To a physician, teaching physician medical medical practice, or a hospital. Excludes practice (or to an physician group practice. physicians who are full-time entity or individual Excludes physicians who employees of the applicable at the request of or are full-time employees of manufacturer. designated on the applicable behalf of a covered manufacturer. recipient or physician). Excludes physicians who are full-time employees of the applicable manufacturer. The quarterly report must disclose: - Physician or physician medical practice name, city and state - Value of payment or other transfer of value, date provided, description of the form of payment or transfer of value (e.g.., cash, in-kind items or services, stock, etc) -If a manufacturer provides a transfer of value to an entity or individual at the request of a covered recipient, then manufacturer shall disclose that transfer under the name of the covered recipient. The annual report must disclose: - Physician or physician medical practice name, business address For a physician, specialty, Medicare billing number - Value of payment or other transfer of value, date provided, description of the form of payment or transfer of value (e.g.., cash, inkind items or services, stock, etc) -If a manufacturer provides a transfer of value to an entity or individual at the request of a covered recipient, then manufacturer shall disclose that transfer under the name of the covered recipient. The annual report must disclose: Physician or physician medical practice name, business address For a physician, specialty, and National Provider Identifier - Value of payment or other transfer of value, date provided, description of the form of payment or transfer of value (e.g.., cash, in-kind items or services, stock, etc) Key change: Rather than reporting the separate entity that receives payments or transfers, the law requires that a requested transfer be disclosed under the name of the individual that requested the transfer. Key change: More information must be disclosed about the physician (business address, specialty, National Provider Identifier), not just the city and state. - A description of the - A description of the - A description of the reason reason for the reason for the payment for the payment should be Prepared by Hart Health Strategies, Up dated 3/30/10 Page 2

3 payment should be indicated as consulting fee, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel, education, research, charitable contribution, royalty or license, ownership or any other reason defined by the Secretary. should be indicated as consulting fee, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel, education, research, charitable contribution, royalty or license, current or prospective ownership or investment income, compensation for serving as faculty or speaker for a CME program, grants, name of the covered drug, device, biological or medical supply (if the transfer of value is related to marketing, education, or research specific to those items) or any other reason defined by the Secretary. indicated as consulting fee, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the specified destinations), education, research, charitable contribution, royalty or license, current or prospective ownership or investment income, compensation for serving as faculty or speaker for a CME program, grants, name of the covered drug, device, biological or medical supply (if the transfer of value is related to marketing, education, or research specific to those items) or any other reason defined by the Secretary. No annual summary. The annual summary must include the aggregate amount of all payments or transfers of value. The annual summary must include the aggregate amount of all payments or transfers of value. What is included A transfer of anything A transfer of anything of A transfer of anything of Key change: Dollar in the definition of value that exceeds value, including any value that exceeds $10 threshold is changed to $10. for a payment or $25 (indexed by compensation, gift, (indexed by CPI), including transfer of value? CPI), including any honorarium, speaking fee, any compensation, gift, compensation, gift, consulting fee, travel, honorarium, speaking fee, honorarium, speaking services, dividend, profit consulting fee, travel, fee, consulting fee, distribution, stock or stock services, dividend, profit Prepared by Hart Health Strategies, Updated 3/30/10 Page 3

4 Exceptions to the definition travel, services, or option grant, or any distribution, stock or stock dividend, profit ownership or investment option grant, or any distribution, stock or interest ownership or investment stock option grant, or interest any ownership or investment interest held by a physician in an applicable manufacturer. - Any payment or other transfer of value where aggregate amount transferred to, requested by, or designated on behalf of the covered recipient or physician does not exceed $500 during the calendar year. - Any payment or other transfer of value where aggregate amount transferred to, requested by, or designated on behalf of the covered recipient or physician does not exceed $100 during the calendar year. --Any payment or other transfer of value of $10 or less where aggregate amount transferred to, requested by, or designated on behalf of the covered recipient or physician does not exceed $100 during the calendar year. Specified CPI increases after Key change: Aggregate payment was originally proposed as $500, but the final law decreased aggregate payment to $100 during a calendar year. Also adds that the aggregate payment will be indexed by CPI after Product samples intended for patients. - Product samples that are not intended to be sold and are intended for patients. - Product samples that are not intended to be sold and are intended for patients. - Education materials for patient use or benefit. - Qualitative value of any training or education related to a payment or other transfer of value - Education materials for patient use or benefit. - Education materials for patient use or benefit. Prepared by Hart Health Strategies, Updated 3/30/10 Page 4

5 Exceptions to the definition (cont.) - Loan of a covered - Loan of a covered device - Loan of a covered device device for a shortterm for a short-term trial period for a short-term trial period trial period (less (less than 90 days) to (less than 90 days) to permit than 90 days) to permit evaluation of the evaluation of the covered permit evaluation of covered device. device. the covered device. - Items or services provided under contractual warranty. - Transfer of value to a physician who is a patient. - Discounts, including rebates. - In-kind items used for charity care. - Items or services provided under contractual warranty. - Transfer of value to a physician who is a patient. - Discounts, including rebates. - In-kind items used for charity care. - Dividend or other profit distribution from, or ownership or investment in, a publicly traded security and mutual fund - Items or services provided under contractual warranty. - Transfer of value to a physician who is a patient. - Discounts, including rebates. - In-kind items used for charity care. - Dividend or other profit distribution from, or ownership or investment in, a publicly traded security and mutual fund -In the case of a selfinsured plan, payments for the provision of health care to employees Key changes: Adds additional exceptions related to health care, for nonmedical services, certain proceedings, and when the manufacturer would not know the identity of the 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 recipient. Prepared by Hart Health Strategies, Updated 3/30/10 Page 5

6 Exceptions to the definition (cont.) 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 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. -- Such term does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient. Physician Manufacturers, Manufacturers and group Manufacturers and group Ownership distributors and purchasing organizations purchasing organizations are group purchasing are required to submit required to submit organizations are information regarding any information regarding any required to submit ownership or investment ownership or investment information regarding interest (other than in a interest (other than in a any ownership or publicly treaded security publicly treaded security and investment interest and mutual fund) held by a mutual fund) held by a (other than in a physician (or an physician (or an immediate Prepared by Hart Health Strategies, Up dated 3/30/10 Page 6

7 Physician Ownership (con.) publicly treaded immediate family family member of that security and mutual member of that physician) in their fund) held by a physician) in their organization during the physician in their organization during the preceding year. organization during preceding year. Information must include the the preceding year. Information must include dollar amount invested by Information must the dollar amount invested each physician holding such include the dollar by each physician holding an ownership or investment amount invested by such an ownership or interest; the value and terms; each physician investment interest; the any payment or other holding such an value and terms; any transfer of value provided to ownership or payment or other transfer a physician holding such an investment interest; of value provided to a ownership interest (or to an the value and terms; physician holding such an entity or individual at the any payment or other ownership interest (or to an request of or designated on transfer of value entity or individual at the behalf of a physician holding provided to a request of or designated on such an ownership or physician holding behalf of a physician investment interest); and such an ownership holding such an ownership any other information the interest (or to an entity or investment interest); Secretary determines or individual at the and any other appropriate. request of or information the Secretary designated on behalf determines appropriate. of a physician holding such an ownership or investment interest). Disclosure of Postpones the Postpones the reporting Postpones the reporting date Key change: Allows for the clinical trials? reporting date of date of payment or other of payment or other transfer non-disclosure for up to 4 payment or other transfer of value made of value made pursuant to a years (up from 2 years in transfer of value made pursuant to a product product development previous drafts) pursuant to a product development agreement agreement for services development for services furnished in furnished in connection with agreement for connection with the the development of a new services furnished in development of a new drug, device, or medical connection with the drug, device, or medical supply, or by an applicable Prepared by Hart Health Strategies, Updated 3/30/10 Page 7

8 Disclosure of clinical trials? (con.) Penalties for noncompliance development of a new supply, or by an applicable manufacturer in connection drug, device, or manufacturer in connection with a clinical investigation medical supply, or by with a clinical investigation until the earlier of either the an applicable until the earlier of either the date of product manufacturer in date of product approval/clearance or 4 connection with a approval/clearance or 2 calendar years after the clinical investigation calendar years after the date of payment. until the earlier of date of payment. either the date of product approval/clearance or 2 calendar years after the date of payment. Minimum $1,000 per violation, not more than $5,000. Minimum $1,000 per violation, not more than $10,000. Minimum $1,000 per violation, not more than $10,000. Key change: Penalty thresholds increased, as compared to earlier drafts. Penalties for noncompliance (con.) Total amount of penalties with respect to each annual submission shall not exceed $50,000. Knowingly failing to submit required information is subject to a minimum penalty of $5,000 per violation, but not more than $50,000 and not to exceed $250,000 annually. Total amount of penalties with respect to each annual submission shall not exceed $150,000. Knowingly failing to submit required information is subject to a minimum penalty of $10,000 per violation, but not more than $100,000 and not to exceed $1,000,000 annually. Any penalties collected shall be used to carry out this section. Total amount of penalties with respect to each annual submission shall not exceed $150,000. Knowingly failing to submit required information is subject to a minimum penalty of $10,000 per violation, but not more than $100,000 and not to exceed $1,000,000 annually. Any penalties collected shall be used to carry out this section. Any penalties collected shall be used to maintain the Internet website Prepared by Hart Health Strategies, Updated 3/30/10 Page 8

9 Public Reporting Procedures for submission& public disclosure making reporting information publicly available. HHS Secretary must HHS Secretary must make HHS Secretary must make make all disclosed all disclosed information all disclosed information information (including (including enforcement (including enforcement enforcement actions actions and any penalties actions and any penalties and any penalties imposed) available on the imposed) available on the imposed) available on Internet by September 30, Internet by September 30, the Internet by September 30, Manufacturers or a covered recipient have the opportunity to review the information that is to be made public before it is made public, and as appropriate, correct such information. The Secretary of HHS is required to establish procedures for the submission of required information, and for making public such information, by November 1, Manufacturers or a covered recipient have the opportunity to submit corrections to the information made public. The Secretary of HHS is required to establish procedures for the submission of required information, and for making public such information, by November 1, Manufacturers or a covered recipient have the opportunity to submit corrections to the information not less than 45 days before the information is made public. Review cannot delay public posting of information. The Secretary of HHS is required to establish procedures for the submission of required information, and for making public such information, by October 1, Key change: Manufacturers and physicians (and other covered recipients) are able to review the information before it is made public. Shifting of the dates, given delayed implementation. Key change: Dates shifted HHS is required to consult with the OIG, affected industry, consumers, and other interested parties. HHS is required to consult with the OIG, affected industry, consumers, consumer advocates and other interested parties. HHS is required to consult with the OIG, affected industry, consumers, consumer advocates and other interested parties. Prepared by Hart Health Strategies, Updated 3/30/10 Page 9

10 Procedures for submission& public disclosure (con.) There shall be no There shall be no judicial No language re: judicial judicial review of the review of the review of the implementation of this implementation of this implementation of this section. section. section. State pre-emption Preempts any State laws or regulations related to the disclosure or reporting of similar information. Reporting of drug sample information Preempts any State laws or regulations related to the disclosure or reporting of this information. Allows the State laws or regulations to seek additional information. Preempts any State laws or regulations related to the disclosure or reporting of this information. Allows the State laws or regulations to seek additional information. n/a n/a Requires prescription drug manufacturers and distributors to report to the Secretary information pertaining to drug samples currently being collected internally, as required under the Federal Food, Drug and Cosmetic Act. Key change: Judicial review language removed. Key change: Pre-emption has moved from a Federal ceiling to a Federal floor. Key change: Separate process in which manufacturers must disclose information related to drug samples. Prepared by Hart Health Strategies, Updated 3/30/10 Page 10