Enhancing Public Transparency in Physician Financial Relationships through Open Payments Program
The Open Payments Program ensures transparency in the healthcare industry by requiring manufacturers to report payments made to physicians and teaching hospitals. This disclosure program aims to promote accountability and a transparent healthcare system. Key terms include Reporting Entities (manufacturers reporting payments) and Covered Recipients (physicians and hospitals receiving payments). The program timeline, including impacts of COVID-19, emphasizes the importance of reporting data for public scrutiny.
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OPEN PAYMENTS Creating public transparency into industry Creating public transparency into industry- physician financial relationships provider financial relationships Annual Pharmaceutical Compliance Congress Veronika Peleshchuk Fradlin Centers for Medicare & Medicaid Services Center for Program Integrity Data Sharing & Partnership Group; Division of Data & Informatics CMS Disclaimer: This information is a summary of sections of the NPPTP. This information is a summary of the final rule implementing the National Physicians Payment Transparency Program (Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests [CMS-5060-F], codified at 42 CFR Parts 402 and 403) The summary is not intended to take the place of the final rule which is the official source for information on the program.
About Open Payments About Open Payments Open Payments is a national disclosure program that promotes a transparent and accountable healthcare system. Each year applicable manufacturers and group purchasing organizations (GPOs) collect data regarding payments or transfers of value they have made to physicians and teaching hospitals. Then in the following calendar year they submit this information to CMS for publication. 2
Key Terms Key Terms Reporting Entities Refers to pharmaceutical and medical device manufacturers and their distributors who are required to report payments and other transfers of value to Open Payments Also referred to as applicable manufacturers and group purchasing organizations (GPOs) Covered recipients Refers to physicians and teaching hospitals receiving payments or other transfers of value from reporting entities 3
Program Year 2019 Timeline Program Year 2019 Timeline 4
COVID COVID- -19 Reporting Impacts 19 Reporting Impacts If you were impacted by the pandemic and were unable to submit data by the March 31st deadline, please use the assumptions statement to explain your reporting methodologies and circumstances related to the pandemic. Include the phrase COVID-19 Impact in your assumptions statement with the explanation of circumstances and, if applicable, include reference to any related help desk ticket numbers Remember: you are still required to submit and attest to all reportable calendar year 2019 data as soon as possible The full Open Payments COVID-19 announcement is available at: https://www.cms.gov/OpenPayments/FAQs/FAQs-openpayments 5
Open Payments Data Publication Open Payments Data Publication 6
Program Year 2019 Data Publication Program Year 2019 Data Publication Total Records Published 10.98 Million Total U.S. Dollar Value $10.03 Billion Research Payments $5.23 Billion Ownership & Investment $1.24 Billion General Payments $3.56 Billion On Tuesday June 30, 2020 CMS published the Program Year 2019 data as well as newly submitted and updated records from previous program years. The Program Year 2019 data publication marks the seventh Open Payments Program reporting cycle. 7
Program Year 2019 Program Year 2019 Percent of Dollar Value by Payment Type Percent of Dollar Value by Payment Type Program Year 2019 Data Dollar Value Ownership & Investment Interests 12% General Payments 36% Research Payments 52% 8
Program Year 2019 Program Year 2019 Record Volume Distribution by Payment Type Record Volume Distribution by Payment Type Ownership & Investment Interest 0.02% Research Payments 5.59% General Payments 94.39% 9
Stakeholders for Program Year 2019 Stakeholders for Program Year 2019 Physicians Receiving Payments 615,000 Teaching Hospitals Receiving Payments 1,196 Companies Making Payments 1,602 10
All Program Years Published Totals All Program Years Published Totals 2013 2013 - - 2019 2019 Total Records Published 76.25 Million Total U.S. Dollar Value $53.06 Billion Research Payments $32.90 Billion Ownership & Investment $1.24 Billion General Payments $18.93 Billion 11
All Program Years All Program Years(2013 Percent of Dollar Value by Payment Type Percent of Dollar Value by Payment Type (2013 2019) 2019) Ownership & Investment Interests 2% General Payments 36% Research Payments 62% 12
All Program Years All Program Years Record Volume Distribution by Payment Type Record Volume Distribution by Payment Type Ownership & Investment Interests 0.003% Research Payments 6.35% General Payments 93.65% 13
Stakeholders for All Program Years Stakeholders for All Program Years (2013 (2013 2019) 2019) Physicians Receiving Payments 1.08 Million Teaching Hospitals Receiving Payments 1,335 Companies Making Payments 2,667 14
Program Years 2014 Program Years 2014 2019 2019 PAYMENT CATEGORIES - Dollar Value BY PROGRAM YEAR $6.00 Billions $5.29 $5.26 $5.23 $5.20 $5.03 $4.77 $5.00 $4.00 $3.56 $2.94 $2.74 $3.06 $2.70 $2.91 $3.00 $2.00 $1.36 $1.24 $1.20 $1.14 $1.12 $1.00 $1.00 $- 2014 2015 2016 2017 2018 2019 General Payments Research Payments Ownership & Investment Interests 15
SUPPORT Act Information SUPPORT Act Information 16
SUPPORT for Patients and Communities Act SUPPORT for Patients and Communities Act The SUPPORT Act was passed in the fall of 2018 and included new Open Payments provisions Covered Recipients to include: Physician Assistants Nurse Practitioners Clinical Nurse Specialists Certified Registered Nurse Anesthetists & Anesthesiologist Assistants Certified Nurse Midwives Publication of National Provider Identifiers (NPIs) This will be effective for data collection beginning in calendar year 2021 that is to be reported to CMS in 2022. 17
Additional Program Updates Beginning in 2021 Additional Program Updates Beginning in 2021 Reporting Requirements for the device identifier component of the unique device identifier for devices and medical supplies Nature of Payment Updates Three new categories will be added: Debt forgiveness Long term medical supply or device loan Acquisitions The two categories related to education programs will be combined into one 18
Preparing for 2021 Preparing for 2021 There are preliminary resources now available on the CMS Open Payments Resource page to help you prepare for the new device reporting requirements. Preliminary Medical Device and Medical Supply Reference Data This preliminary reference data includes medical device and medical supply names and Primary Device Identifier Information for all the medical device and medical supplies listed in the Food and Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID) through June 30, 2020. Medical Device and Medical Supply Name and Primary Device Identifier Instructions Document The instructions document provides details about the use of the Device Name and Primary Device Identifier dataset. 19
Device Reporting FAQs Device Reporting FAQs 20
New FAQ #2007 New FAQ #2007 Which marketed names and device identifiers should an entity report when a single transaction is related to multiple products or multiple device identifiers? If the payment or transfer of value is related to multiple devices or medical supply products, the reporting entity may report up to five products. Each product may be reported with a combination of the marketed name (brand name) and one device identifier. If a reported device is associated with multiple device IDs, it is up to reporting entity s discretion to identify the representative device ID for that product. Reported brand names and device identifiers will be validated against the information from the Global Unique Device Identification Database (GUDID). Reporting entities are responsible for making a determination about which combination(s) of brand names and device identifiers to report, but are encouraged to note any assumptions made or methodologies used to determine which device brand names and device identifiers to report in the assumptions statement. 21
Other Helpful FAQs Other Helpful FAQs Device Reporting Device Reporting Additional FAQs that you might find helpful as you prepare for the device reporting requirements are: FAQ #8258 FAQ #8392 FAQ #9124 FAQ #9132 All Open Payments FAQs are available in the FAQ document which is located on the Open Payments Resources page as well as the Open Payments FAQ Page. 22
Covered Recipient Expansion Covered Recipient Expansion Resources & FAQs Resources & FAQs 23
Tips for Preparing for 2021 Tips for Preparing for 2021 Familiarize yourself and your teams with the new reporting requirements and definitions. A series of new FAQs and various resources related to reporting on the added covered recipients will be available soon. Share the expansion information with the providers you interact with A resource has been created to help familiarize the newly added providers with Open Payments. We encourage you to refer them to this page to help them learn more about the program and how they can prepare for these changes. https://www.cms.gov/OpenPayments/Program-Participants/Newly-Added- Covered-Recipients 24
Upcoming Resources Upcoming Resources Reporting on Added Covered Recipients Reporting on Added Covered Recipients Preliminary Program Year 2021 Data Submission Mapping Document August 2020 release Preliminary Program Year 2021 Change Summary Document August 2020 release Preliminary Sample Files for Program Year 2021 August 2020 release Taxonomy Code List including taxonomies for non- physician practitioners September 2020 Release 25
Preliminary Non Preliminary Non- -Physician Practitioner List Physician Practitioner List Preliminary Non-Physician Practitioner List (PnPPL) This list will be provided to help reporting entities pre- validate their data before submitting it to CMS Similar to the Validated Physician List, PnPPL will represent a subset of all reportable providers It will include identifying information for providers registered in CMS systems Further details forthcoming Release anticipated in mid to late fall 26
Upcoming FAQs Upcoming FAQs How should I decide which provider type to report if a provider s licensing state does not have separate licensing programs for non-physician practitioner types? Reporting entities should use their best knowledge of the provider and the credential(s) the provider practices under to make a selection. Reporting entities are encouraged to use the assumptions document to note the methodologies used in their reporting. 27
Upcoming FAQs Upcoming FAQs Will all non-physician practitioners be required to obtain National Provider Identifier (NPI) numbers? No, Open Payments does not have a specific authority to require non- physician practitioners to obtain NPIs How should I report non-physician practitioners that do not have NPIs? For non-physician practitioners without an NPI, reporting entities may report up to 5 state licenses on the payment record. Matching will be performed based on the combination of first name, last name, and state license information. Please note that reported providers do not have to have a specific PA, NP, CNS, CRNA or CNM credential associated with their state license to be successfully validated. CMS is aware that not all states license providers for each of the listed credentials and will be able to validate reported data regardless of whether reported license(s) are for a specific non-physician practitioner type or a broader category of Registered Nurse. 28
Additional Resources Additional Resources The preliminary resources to help get you started for the 2021 data collection are available on our resources page. In addition to this we will soon be launching a new page on our Open Payments website (https://cms.gov/openpayments) that will be dedicated to sharing information and resources to assist you with the new requirements. When this page is launched we will send out a notice via our listserv, so if you aren t subscribed be sure to sign up! 29
Stay Connected Stay Connected VISIT THE OPEN PAYMENTS WEBSITE o For resources including Open Payments FAQs and more information about the program visit https://cms.gov/openpayments SUBSCRIBE TO THE LISTSERV o Receive program updates through the Open Payments listserv o Subscribe at our Contact Us page SEARCH THE DATA o Access the Open Payments data at https://openpaymentsdata.cms.gov HAVE QUESTIONS OR NEED HELP? o Email: openpayments@cms.hhs.gov o Call: 1-855-326-8366 (TTY Line: 1-844-649-2766) 30
