Life Science Compliance Update

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December 20, 2011

Physician Payment Sunshine Act: CMS Proposed Regulations -- Public Posting, Data Submission and Correction

Reviewing Data
The Centers for Medicare and Medicaid Services (CMS) released the proposed regulations for the Physician Payment Sunshine Provisions of Affordable Care Act.  In this rule there is extended discussion on the review and submission process for the data.  This article focuses on the Submission and Correction portions of the proposed rule.

Report Submission and Correction 

The statute requires the Secretary to establish procedures for applicable manufacturers and applicable GPOs to submit the required information. CMS said it recognizes that these regulations would require applicable manufacturers and applicable GPOs to collect and submit large amounts of new data, and will strive to be as flexible as possible about the data collection and submission methods. 

CMS plans to work with applicable manufacturers and applicable GPOs to create the best system for all parties involved. Based on stakeholder outreach and analysis of the data systems available, CMS is proposing a potential system for the submission of data to CMS.  CMS seeks comments on the proposed approach and whether an alternative system would be preferable. 

Prior to Submission 

CMS is considering ways to ease the post-submission review process of this information and facilitate early resolution of conflicts between applicable manufacturers, applicable GPOs, covered recipients and physician owners or investors. CMS seeks comments on a way for applicable manufacturers and applicable GPOs to make necessary corrections prior to submission to CMS, thus lessening potential changes during the statutory review and correction period, and thereby strengthening the accuracy of the data. 

One way to achieve this is for applicable manufacturers, prior to submitting data to CMS, to provide each covered recipient with information regarding the payments or other transfers of value that the applicable manufacturer plans to report to CMS as having made to the covered recipient.  Similarly, applicable manufacturers and applicable GPOs could provide to each physician owner or investor the information they plan to report regarding the ownership and investment interests held by the physician owner or investor. While CMS is not proposing to require this type of pre-review, we recommend that applicable manufacturers and applicable GPOs provide for a "pre-submission review," and we seek comment on whether a pre-review of this nature would be useful. 

Report Submission 

Applicable manufacturers and applicable GPOs are statutorily required to submit their reports electronically to CMS on March 31, 2013 and on the 90th-day of each calendar year thereafter

CMS proposes to interpret "on" March 31, 2013 or the 90th of the each year thereafter as "by" March 31, 2013 or the 90th of each year thereafter and intend to allow applicable manufacturers and applicable GPOs to submit data prior to this date to provide applicable manufacturers and applicable GPOs with more flexibility for submission. CMS proposes that only applicable manufacturers that have payments or other transfers of value and/or physician ownership or investment interests to disclose for the previous calendar year must register and submit reports. If an applicable manufacturer neither made any payments or other transfers of value required to be reported nor had any physician owners or investors in the previous calendar year, it need not submit a report to CMS. 

Similarly, only applicable GPOs with physician owners or investors are required to submit information. For applicable manufacturers and applicable GPOs that do have information to disclose, CMS proposes that applicable manufacturers and applicable GPOs register with CMS prior to submission to facilitate communication. This registration process would require the applicable manufacturer or applicable GPO to designate a point of contact, which CMS would use for communications related to the submitted data. CMS proposes that applicable manufacturers or applicable GPOs must register prior to the submission of data for the current reporting cycle. 

CMS does not limit the time prior to the submission of data, so an applicable manufacturer or applicable GPO could choose to submit the data immediately after registration. CMS is proposing to open the registration process at the beginning of the calendar year, giving applicable manufacturers and applicable GPOs time to register and submit their data. The first opportunity for registration and the data submission would be January 1, 2013. CMS seeks comment on the proposed timing of the registration and submission process. 

Alternatively, CMS is considering requiring that all applicable manufacturers and applicable GPOs register with CMS, regardless of whether they have information to report. If an applicable manufacturer or applicable GPO had no payments or transfers of value and/or ownership or investment interests to report, the chief executive officer, chief financial officer or chief compliance officer would be required to submit an attestation that, to the best of his or her knowledge and belief, there were no reportable payments or transfers and value and/or ownership or investment interests during the previous calendar year. CMS believes this may help them better understand the extent of these relationships (including which types of entities have financial relationships with covered recipients and physician owners and investors and which do not). 

Additionally, CMS believes such a requirement would ensure that applicable manufacturers and applicable GPOs perform a more thorough evaluation to determine whether they have any reportable information. However, CMS is seeking input on whether requiring registration for all entities and an attestation from entities with no reportable information would be more burdensome than beneficial. CMS seeks comment on both the benefits and burdens of this consideration and intend to finalize the agency's position on this in the final rule based on comments received

CMS proposes that applicable manufacturers and applicable GPOs submit their data electronically in a comma-separated value (CSV) format. Each line item in the dataset should represent a unique payment or other transfer of value, or a unique ownership or investment interest. In the event that a single file does not have sufficient volume for all the data required, then the applicable manufacturer or applicable GPO may submit as many files as necessary to provide the entirety of its data. 

CMS seek comments on the appropriateness of the CSV format for data submission, and suggestions for alternative formats. Additionally, CMS proposes that annually, following the submission of data, an authorized representative from each applicable manufacturer and applicable GPO will be required to submit a signed attestation certifying the truth, correctness ,and completeness of the data submitted to the best of the signer's knowledge and belief. Such attestations must be signed by the chief executive officer, chief financial officer or chief compliance officer. 

Report Format 

CMS outlined the fields of information to be included when reporting payments or other transfers of value and physician ownership and investment interests . The asterisks indicate the additional information, which CMS proposes to require under the discretion provided by the statute. The justification for the submission of these additional data requirements is provided throughout the preamble. 

In the Addendum to the proposed rule, CMS provided a sample of the reporting template, and will place a spreadsheet in the regulatory docket on Regulations.gov.  For each payment and other transfer of value, CMS is proposing that the following information is required: 

● Applicable manufacturer or applicable GPO name.

● Covered recipient's or physician owner's (as applicable)--

  • Name (for physicians include first and last name, and middle initial);
  • Specialty (physician only);
  • Business street address (practice location);
  • NPI (physician only);

● Amount of payment or other transfer of value in U.S. dollars.

● Date of payment or other transfer of value.

● Form of payment or other transfer of value.

● Nature of payment or other transfer of value.

● Name of the associated covered drug, device, biological, or medical supply, as applicable.

● Name of entity that received the payment or other transfer of value, if not provided to the covered recipient directly.*

● Whether the payment or other transfer of value was provided to a physician holding ownership or investment interests in the applicable manufacturer. (Yes or No response)

● Whether the payment or other transfer of value should be granted a delay in publication because it was made pursuant to a product research agreement, development agreement, or clinical investigation. (Yes or No response) 

CMS seeks comment on the proposed requirements regarding the data elements that should be submitted and plans to finalize them in the final rule based on comments received

45-Day Review Period  

The Act requires that the Secretary allow applicable manufacturers, applicable GPOs, covered recipients, and physician owners or investors the opportunity to review the data submitted for a period of at least 45-days prior to the data being made available to the public. After the due date has passed, and CMS has received the data, it will aggregate the data by individual covered recipient and physician owner or investor, across applicable manufacturers and applicable GPOs. 

Once the data aggregation is complete, CMS plans to notify all applicable manufacturers, applicable GPOs, covered recipients, and physician owners or investors about the procedures for the review.  CMS proposed notice a few ways: allow, but not require, covered recipients, and physician owners or investors to register with CMS to ensure they receive communication about the processes for review. Additionally, notify physicians and hospitals through CMS' list serves and posting the information publicly. 

CMS is considering a posting either on the CMS website or on the Federal Register, and seeks comment on which would be most useful to physicians and teaching hospitals. CMS proposes that these notifications would be provided annually to announce the covered recipient and physician owner and investor review and correction period, and would include the specific instructions for performing this review. For example, CMS is considering that covered recipients and physician owners and investors would sign in to a secure website to see the information reported about them. 

CMS is also considering an alternative method, in which we would require applicable manufacturers and applicable GPOs to collect and report whether the covered recipient, or physician owner or investor would like to be notified by USPS or email of the processes for their review, as well as the individual's email address, if indicated. CMS seeks comment on the proposed method of notification, as well as the alternative method provided, and solicit comments on other ways that CMS, applicable manufacturers, or applicable GPOs can provide timely, adequate, and costeffective notice to covered recipients and physician owners or investors of their opportunity to review the collected data. 

CMS is working on identifying a streamlined and automated process for reporting disputes between applicable manufacturers or applicable GPOs and covered recipients and changes to ensure that the review and correct process is as smooth as possible. CMS will provide more information on the details of this process once it has been fully developed, but provide general guidelines for comment at this time. 

CMS proposes that covered recipients, and physician owners or investors may request from CMS the contact information for a specific applicable manufacturer or applicable GPO, in the event of a potential dispute over the reported data. However, it would be the responsibility of the covered recipient, or physician owner or investor to contact and try to resolve the dispute with the applicable manufacturer or applicable GPO. CMS proposes that at least one of any entity involved must report to CMS that a payment or other transfer of value, or ownership or investment interest is disputed and the results of that dispute at the end of the 45-day review period. 

If an applicable manufacturer or applicable GPO, and covered recipient, or physician owner or investor have contradicting information that cannot be resolved by the parties involved, then CMS proposes that the data would be identified as contradictory and both the original submission from the applicable manufacturer or applicable GPO, and the modified information provided by the covered recipient, or physician owner or investor would appear in the final publicly available website. 

CMS is considering that in these cases (when a dispute over the data cannot be resolved by the parties), the individual payment would be flagged as contested, but the contradictory data, as corrected by the covered recipient or physician owner or investor, would be used for aggregated totals for the physician, as necessary. CMS is seeking comment on this proposal and suggestions for how best to handle instances where there are outstanding disagreements. 

Finally, CMS proposes that the 45-day review period is the primary opportunity to correct errors or contest the data submitted by applicable manufacturers and applicable GPOs to CMS. Once the 45-day review period has passed and the parties have identified all changes or disputes and CMS has made or noted them all, CMS propose that neither applicable manufacturers, applicable GPOs, covered recipients, nor physician owners or investors would be permitted to amend the data for that calendar year. CMS believes that allowing continual changes would be operationally difficult for CMS to handle and would reduce the utility of the data set. 

CMS proposes that applicable manufacturers, applicable GPOs, covered recipient, or physician owners or investors alert CMS as soon as possible regarding any errors or omissions, but these changes may not be made until the data is refreshed for the following reporting year. At that time, all parties would once again have an opportunity to review and amend the data. However, CMS proposes that it would have the option to make changes to the data at any time (for example, to correct mathematical mistakes). 

CMS also proposes that only the current and previous year would be available for review and correction. For example, during the 45-day review period in 2014, applicable manufacturers, applicable GPOs, covered recipients, and physician owners or investors would be able to review and amend the data submitted for 2012 and 2013. However, during the 2015 review, only 2013 and 2014 would be available for changes. CMS seek comments on the procedures outlined for data submission and the 45-day review period, particularly the best way to contact covered recipients and physician owners or investors to ensure they receive notification of the review period.

C. Public Availability 

Under the statute, CMS is required to publish on a publicly available website the data reported by applicable manufacturers and applicable GPOs for CY 2012 by September 30, 2013. For each year thereafter, CMS must publish the data for the preceding calendar year by June 30th. The public website must be searchable, understandable, downloadable, and easily aggregated on various levels, as stated in the statute. In addition, section 4 of Executive Order 13563 calls upon agencies to consider approaches that "maintain flexibility and freedom of choice for the public," including the "provision of information to the public in a form that is clear and intelligible." CMS request comments on how to structure this website for ultimate usability. 

As required in the Act, CMS proposes that the following information on payments and other transfers of value would be included on the public website in a format that is searchable, downloadable, understandable and able to be aggregated: 

  • Applicable manufacturer name.
  •  Covered recipient's—
    • Name;
    • Specialty (physician only); and
    • Business street address (practice location).
    • Amount of payment or other transfer of value in U.S. dollars.
    • Date of payment or other transfer of value.
    • Form of payment or other transfer of value.
    • Nature of payment or other transfer of value.
    • Name of the covered drug, device, biological, or medical supply, when applicable.
    • Name of entity that received the payment or other transfer of value, if not provided to the covered recipient directly. 

In addition, as required by statute, CMS proposes that the website will include: 

  • Information on any enforcement activities taken under section 1128G of the Act for the previous year,
  • Background or other helpful information on relationships between the drug and device industry and physicians and teaching hospitals, and
  • Publication of information on payments or other transfers of value that were granted delayed reporting, as required under section 1128G(c)(1)(C) of the Act.  

Beyond the information required by statute, CMS proposes that the website clearly state that disclosure of a payment or other transfer of value on the website does not indicate that the payment was legitimate nor does it necessarily indicate a conflict of interest or any wrongdoing.  CMS welcomes comment regarding the details and format for how this information should be displayed on the website.

To Submit Comments

Comments are due by 5:00pm Eastern, February 17, 2012.

You may submit comments in one of four ways

Electronically: You may submit electronic comments on this regulation to

http://www.regulations.gov. Follow the "Submit a comment" instructions.

Regular mail

CMS-5060-P 3

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-5060-P,

P.O. Box 8013,

Baltimore, MD 21244-8013. 

Express or overnight mail

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-5060-P,

Mail Stop C4-26-05,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

By hand or courier.

Washington, DC

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Room 445-G, Hubert H. Humphrey Building,

200 Independence Avenue, SW.,

Washington, DC 20201

CMS-5060-P 4

 

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