Life Science Compliance Update

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August 08, 2013

Physician Payment Sunshine Act: Deadlines, Resources and Responsibilities

With the Physician Payment Sunshine Act shining bright, and transparency moving forward, Policy & Medicine wanted to provide a user-friendly resource for other stakeholders regarding important information and dates that the Centers for Medicare & Medicaid Services (CMS) is providing through their "Open Payments" webpage. CMS has provided several easy to follow charts with important dates and brief descriptions that will provide a useful reference to all stakeholders.

As a reminder, you can sign up to receive notifications from CMS regarding the Open Payments program. To do so, go to the "Open Payments" website, scroll to the bottom of the page and enter your email to "receive email updates." Once entered, you will need to scroll down the list of programs and under "Regulations & Guidance" check off "Open Payments" to receive email updates.

Questions can be sent to OPENPAYMENTS@cms.hhs.gov.

DATA COLLECTION

Data Collection

  

Applicable Manufacturers

Applicable GPOs

Physicians

Teaching Hospitals

Who must collect the data for submission to CMS?

Yes

Yes

No, physicians are not responsible for collecting the data for submission to CMS.

No, teaching hospitals are not responsible for collecting the data for submission to CMS.  

What data must be tracked, collected and reported to CMS?

  

Payments or other transfers of value made to physicians and teaching hospitals.

Certain ownership or investment interests held by physicians or their immediate family members.

Payments or other transfers of value made to physician owners or investors.

Certain ownership or investment interests held by physicians) or their immediate family members.

Physicians are not required to report any data to CMS.  However, physicians should refer to the "OPEN PAYMENTS Fact Sheet for Physicians" to learn more about what will be reported about them and how to ensure accurate reporting.

  

Teaching Hospitals are not required to report any data to CMS.  However, Teaching Hospitals should refer to the "OPEN PAYMENTS Fact Sheet for Teaching Hospitals" to learn more about what will be reported about them and how to ensure accurate reporting.

When must data collection start for the 2013 OPEN PAYMENTS Program cycle?

August 1, 2013

Does not apply

When does data collection end for the 2013 OPEN PAYMENTS Program cycle?

December 31, 2013

Does not apply

When must reporting entities start to collect data for future OPEN PAYMENTS Program cycles (beyond 2013)?

January 1

Does not apply

When does data collection end for future OPEN PAYMENTS Program cycles (beyond 2013)?

December 31

Does not apply

  • The first OPEN PAYMENTS Program cycle has a partial data collection period (5 months (August 1- December 31, 2013)).
  • All other OPEN PAYMENTS Program cycles (beyond 2013) will consist of a full 12 months of calendar-year data to be collected and reported to CMS.

Data must be published by CMS online no later than September 30, 2014. For future years, data will be published on June 30.

REGISTRATION

Registration

  

Applicable Manufacturers

Applicable GPOs

Physicians

Teaching Hospitals

Who registers with CMS?

Yes, but only if there is data that has to be reported for the program cycle

Yes, but only if there is data that has to be reported for the program cycle

Optional, not required.  Registering allows data to be seen and corrected before it is publicly posted.  

Optional, not required.  Registering allows data to be seen and corrected before it is publicly posted.  

When does registration start for the 2013 program cycle?

Early 2014

Early 2014

Physicians may register with the OPEN PAYMENTS system at any time beginning in early 2014

Teaching Hospitals may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

When does registration end for the 2013 program cycle?

90 days after registration starts

90 days after registration starts

Physicians may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

Teaching Hospitals may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

When does registration start for on-going program cycles?

January 1

January 1

Physicians may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

Teaching Hospitals may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

When does registration end for on-going program cycles?

March 31

March 31

Physicians may register with the OPEN PAYMENTS system at any time beginning in early 2014.

Teaching Hospitals may register with the OPEN PAYMENTS system at any time beginning in early 2014.  

Additional Notes

The registration and identity vetting process may take up to a week to complete, so it is advised that individuals representing Applicable Manufacturers register as soon as possible in order to avoid delays in data submission.

The registration and identity vetting process may take up to a week to complete, so it is advised that individuals representing Applicable Manufacturers register as soon as possible in order to avoid delays in data submission.

Registration that occurs beyond the review and dispute period does not guarantee that any changes can be made to inaccurate data being displayed.

Registration that occurs beyond the review and dispute period does not guarantee that any changes can be made to inaccurate data being displayed.

  • All applicable manufacturers and applicable GPOs, who have information to report, must register with the OPEN PAYMENTS system using a CMS secure website prior to the submission of data for each reporting year.
  • Physicians and teaching hospitals are encouraged to register with the OPEN PAYMENTS system, so that they are able to review submitted data to ensure it is accurate and complete, and if not, dispute the information and work with applicable manufacturers and applicable GPOs to make any necessary corrections to the information before CMS releases those data to the public.

DATA SUBMISSION

Data Submission

  

Applicable Manufacturers

Applicable GPOs

Physicians

Teaching Hospitals

Who must submit the data to CMS?

Yes, if they meet definition of an applicable manufacturer in 42 CFR 403.902 and have information to report

Yes, if they meet definition of an applicable GPO as stated in 42 CFR 403.902 and have information to report

Does not apply.  Physicians do not have to submit data to CMS.

Does not apply.  Teaching hospitals do not have to submit data to CMS.

When does submission start for the 2013 program cycle?

Early 2014

Early 2014

Does not apply

Does not apply

When does submission end for the 2013 program cycle?

90 days after submission starts

90 days after submission starts

Does not apply

Does not apply

When does submission start for on-going program cycles?

January 1

January 1

Does not apply

Does not apply

When does submission end for on-going program cycles?

March 31

March 31

Does not apply

Does not apply

Submission File Specifications

  

Applicable Manufacturer

Applicable GPO

General payment submission file specifications (non-research)

Used to report payments or other transfers of value to covered recipients (physicians and teaching hospitals) that are not made in connection with an activity that meets the definition of research in the final rule.

Used to report payments or other transfers of value to physician owners or investors that are not made in connection with an activity that meets the definition of research in the final rule.

Research payment submission file specifications

Used to report payments or other transfers of value to covered recipients (physicians and teaching hospitals) made in connection with an activity that meets the definition of research in the final rule.

Used to report payments or other transfers of value to physician owners or investors made in connection with an activity that meets the definition of research in the final rule.

Ownership and investment interest submission file specifications

Used to report all ownership or investment interests that are held by physicians or their immediate family members.

Used to report all ownership or investment interests that are held by physicians or their immediate family members.

These submission file specifications have fields for:

  • Data Element titles;
  • Descriptions and definitions of the data elements;
  • Acceptable field formats and values;
  • Descriptions of whether each element is required or optional for successful submission;
  • Other information to aid in the data collection process.

The submission file specifications provide a list of the data elements that applicable manufacturers and GPOs must collect and report to CMS. The OMB control number is 0938-1173.

Specifications for future OPEN PAYMENTS Program cycles will be posted by October 1 of each preceding calendar year, before data collection begins.

Lists of Teaching Hospitals (2013)

CMS will post a downloadable list (in CSV format, Microsoft Excel format and Adobe .pdf format) of all teaching hospitals for applicable manufactures to use for the 2013 OPEN PAYMENTS Program cycle.  This list identifies hospitals deemed as Teaching Hospitals in accordance with the OPEN PAYMENTS Final Rule and will help applicable manufacturers determine if payments to these entities need to be reported. The teaching hospital list

  • Indicates all hospitals that have received a payment(s) under a Medicare direct graduate medical education (GME), inpatient hospital prospective payment system (IPPS) indirect medical education (IME) or psychiatric hospitals IME programs during the latest calendar year for which such data is available;
  • Includes hospital names, addresses and taxpayer identification numbers (TINs);
  • Will be specific to a single OPEN PAYMENTS Program cycle (i.e., 2013); and,
  • Will be posted approximately 90 days prior to the data collection period beginning for each OPEN PAYMENTS Program cycle (May 3, 2013 for the 2013 OPEN PAYMENTS Program cycle, and October 1 for future OPEN PAYMENTS Program cycles).

REVIEW, DISPUTE & CORRECTION PROCESSES

Review, Dispute and Correction Processes

During:

What Happens During Review?

What Happens During Dispute?

What Happens During Correction?

Day 1-45

• Applicable manufacturers, applicable GPOs, physicians and teaching hospitals review their data before it is made public

• Physicians and teaching hospitals can dispute information reported about them or their institutions.
• Disputes initiated during this 45 day period that do not get resolved will be in the public data, but shown as under dispute.
• CMS will not mediate any dispute.

• Applicable manufacturers and applicable GPOs should work with the disputing physician or teaching hospital to correct disputed data.
• Applicable manufacturers or applicable GPO must send CMS a revised report to make the corrections and re-attest to the updated data.

Day 46-60

• Applicable manufacturers and applicable GPOs seek to resolve disputes received from physicians or teaching hospitals.
• Physicians and teaching hospitals may continue to review the data.

• Physicians and teaching hospitals may continue to initiate disputes during this period but resolutions may not be reflected in publicly displayed data.

• Applicable manufacturers and applicable GPOs should work with physicians and teaching hospitals to make corrections.
• Corrections made to disputes issued during this 15 day window (and resubmitted) may not be in the public data.
• Applicable manufacturers and applicable GPOs must send CMS a revised report to make the appropriate corrections and re-attest to the updated data.

 

  • The review and resolution period starts at least 60 days before the information is made public to allow for the 45 day and 15 day periods described above.
  • If the applicable manufacturer or applicable GPO can't resolve the dispute with the physician or teaching hospital and correct the data in the initial 45-day or subsequent 15-day period, the applicable manufacturer or applicable GPO and covered recipient or physician owner or investor should continue to seek a resolution.
  • Physicians and teaching hospitals should be aware that corrections from disputes initiated after the 45 day period may not be:
      - Reflected initial public data, or
      - Pursued or corrected by applicable manufacturers or applicable GPOs
  • The review and resolution system is open year-round, but only disputes initiated during the 45-day period and resolved during the subsequent 15-day dispute resolution period will be guaranteed to be in the initial public posting of data.
  • During the 15-day period, new disputes issued or corrections may not be in the initial public posting of data.
  • CMS will update data from the current and previous year at least once annually, in addition to the initial data publication that followed the data submission. Data updates will be included when possible during data refresh.
  • In cases where a dispute cannot be resolved, the latest, attested-to data submitted by the applicable manufacturer or applicable GPO will be published and marked under dispute.
  • CMS will monitor the disputes and resolutions to inform the auditing process:
     - How often disputes are reported by physicians and teaching hospitals
     - The volume of disputes unresolved between physicians, teaching hospitals, and applicable manufacturers and applicable GPOs.

Data corrections made by applicable manufacturer or applicable GPOs may be made at any time and the corrections will be updated with the next data refresh.

CMS RESOURCES

Continuing Medical Education (CME): Offered by CMS through Medscape

  1. Are You Ready for the National Physician Payment Transparency Program?
  2. “The Physician Payment Transparency Program and Your Practice” for physicians to review transfers of value attributed to them and differentiate types of transfers of value that will or will not be reported under

POLICY & MEDICINE RESOURCES

CMS FAQs Organized by Category (and regularly updated)

Physician Payment Sunshine Act: Listing of Policy and Medicine Articles on Open Payments

Quick Reference Guide

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