Summary of 30-dya public Comments

Commenters

#

Common Theme

Academy of Physicians in Clinical Research

AdvaMed

Aggregate Spend Alliance

American Association of Clinical Endocrinologists

American Academy of Dermatology Association

American Academy of Physical Medicine and Rehabilitation

American Association of Neurological Surgeons and Congress of Neurological Surgeons

American Association of Orthopaedic Surgeons

American College of Cardiology

American College of Emergency Physicians

American College of Physicians

American Medical Association

American Optometric Association

American Osteopathic Association

American Podiatric Medical Association

American Urological Association

Association of American Medical Colleges

Association of Clinical Research Professionals

CME Coalition

Johns Hopkins Medicine

Kyruus

Massachusetts Medical Society

MedChi The Maryland State Medical Society

Medical Group Management Association

Medical Society of New Jersey

Pew Charitable Trust

Pfizer

PhRMA

Primacea

Rutgers, NJ

Rutgers, NJ

Unknown Organiation

Upsher-Smith

Various individuals (Applebaum, MD, Lexchin, MD, Wen, MD, Smith, Burton)

Summary of Comment

Proposed Reponses

1

Unilateral dismissal of disputes

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Many commenters were concerned with whether manufacturers would be allowed to unilaterally dismiss disputes. Commenters pointed out the proposed language to manufacturers to be provided after a dispute is initiated states that “you may resolve the dispute by submitting and attesting to the corrected data. After reviewing the disputed information, you may dismiss the dispute or request that physician or teaching hospital who initiated the dispute to withdraw it.” Commenters stated that unilateral dismissals by the manufacturer are contrary to the final rule, which provides that the parties to the dispute may and should continue to work to reach resolution, but that this data would be marked as “in dispute” until an agreement is reached.

We appreciate and agree with the comments that manufacturers should not unilaterally dismiss disputes that the physician does not consider resolved. We believe that all disputes should be resolved as described in the final rule whereby our system is reported the results of that resolution process. We believe that the terminology describing the system functionality made available to applicable manufacturers and applicable GPOs, mischaracterizes the opportunity to report that the dispute has been resolved in accordance with the rule. As a result, we are clarifying the language presented in the system to illustrate our stance that compliance with the final rule's description of how disputes shall be resolved predicates the use of the system functionality provided. Any dispute that is unresolved will be posted on the public website, yet marked as "disputed" in accordance with § 403.908(g)(4)(iii)

2

Attestation clause or penalty for physicians for bad faith disputes

X

The commenters suggested that physicians should have an attestation clause as well, or penalties for bad faith disputes.

We appreciate the comments, but we do not have the authority to require physicians to attest to their dispute or subject physicians to civil monetary penalties for bad faith disputes.

3

Limit the number of disputes initiated

X

X

X

Commenters suggested limiting the period for dispute or the number of times a dispute can be initiated.

We appreciate the comment, but we do not have the authority to limit the number of times a record may be disputed. Section 1128G(c)(1)(D) of the Social Security Act requires that CMS provide a review/dispute and correction period of "not less than 45 days", and we are providing a 45-day review and additional 15 day correction period.

4

Physician reputation implications

X

X

X

X

X

X

X

Some commenters pointed out that physicians bear the risk of potential employment and reputational implications due to improper dismissals and incorrect data.

We appreciate the comments and are sympathetic to the possibility of reputational implications to physicians. However, Section 1128G(c)(1)(D) of the Social Security Act requires that CMS provide a review and correction period of "not less than 45 days", and we are providing a 45-day review and additional 15 day correction period. Physicians will have the time required to work with applicable manufacturers and group purchasing organizations to resolve any incorrect data.

5

Calendar year dispute limitation

X

X

X

X

X

X

Commenters were also concerned about the inability to initiate a dispute after a calendar year. Other commenters supported the calendar year limitation.

We appreciate the comments, but we do not have the authority to alter the existing calendar year dispute limitation.

6

Extend/Maintain 45 day review window

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Many commenters thought the 45-day dispute period was too short for physicians to review the data and initiate a dispute. The commenters noted the busy schedules of physicians and the burden it places on them to review the data. Other commenters disagreed that the 45-day review period was too short.

We appreciate the comments and are sympathetic to the need to provide time for review and correction and tried to maximize the time as much as possible. Section 1128G(c)(1)(D) of the Social Security Act requires that CMS provide a review and correction period of "not less than 45 days", and we are providing a 45-day review and additional 15 day correction period. In order to meet the other statutorily mandated deadlines, we do not believe that additional time may be granted in this first year of the Open Payments program.

7

Postpone public reporting by 6 months

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Numerous commenters were concerned with the implementation timeline and the September 30, 2014 publication date. These commenters suggested that the date be pushed back 60 days. Other commenters supported the current timeline, noting that while the dispute resolution process is important, this should not interfere with or delay the timely release of physician payments data to the public.

We appreciate the comments, but we do not have the authority to alter the publication date.

8

Need for education and outreach

X

X

X

X

X

X

X

Commenters noted the need for increased education due to the confusion on the registration and dispute process, as well as additional time to register. Some commenters pointed out that the physician registration date was pushed back from January 1 to June 1, 2014, not allowing adequate time for physician registration. Commenters worried that there is not enough time for outreach to physicians. One commenter suggested providing more explanatory materials to physicians to assist in their review.

We appreciate the comments and agree that additional outreach and education resources should be made available to both physicians and applicable manufacturers and GPOs. We will provide periodic updates to education material on our website and through our listserv.

9

Require details from physician when dispute is initiated

X

X

X

X

X

Several commenters suggested that the “reason for dispute” comment field should be required for every disputed record. One commenter recommended that CMS provide a list of potential reasons to select from. Another commenter suggested that the system allow the covered recipient to complete / aut-fill various points about the record which it is disputing. Another commenter suggested that each dispute would require explanation of which data is incorrect, why it is incorrect, what the correct amount should be, and supporting evidence, if any. Another commenter suggested a design feature whereby the disputed record would contain the amount of the payment or other transfer of value which the covered recipient believes to be accurate. One commenter suggested that the physician be limited to disputing only the date and the amount of the payment or transfer of value. One commenter also suggested to provide recipients with a list of potential reasons to select from for the portion of the data that is being disputed.

We appreciate the comments and note that the system as designed requires physicians to enter information into the comment field for disputes. The final rule states that a physician will "be directed to fill out electronic fields detailing the dispute, including the proposed corrections." Additionally, we will provide sample language for physicians to provide guidance for the information needed in order to assist the manufacturer in investigating and resolving the dispute.

10

Inquiry into how data will be presented on public site

X

X

X

X

X

X

X

X

X

X

X

X

X

Several commenters recommended that data not be published if it is in dispute by both parties. Another commenter suggested separating the data into undisputed data, followed by disputed data. One commenter recommended that payments be marked as "under review" instead of "disputed". One commenter suggested that there be clear language that explains the meaningful context of disputed versus undisputed data. Another commenter questioned the difference between "affirming" a payment or other transfer of value and doing nothing (not disputing).

We appreciate the comment. The system as designed will show the disputed data on the public site as disputed on a detailed level. We will consider publishing physician dispute numbers in the future, however users will be able to conduct this analysis on their own from the published data. As stated in the final rule, payments that are not resolved will be marked as disputed, but the most recent attested account by the applicable manufacturer only will be published. Regarding the question of the difference between "affirming" a payment or other transfer of value verses non-disputed payments; each will be presented on the public site without a dispute marker associated.

11

Physician dispute rate

X

A commenter recommended that the physician dispute rate be tracked as well, similar to the manufacturer dispute rate. Another commenter suggested that the physician value should be listed along with the manufacturer's for unresolved disputes.

Thank you for your comment. This suggestion is outside the scope of PRA.

12

Inquiry into how notifications will be sent for dispute actions

X

X

X

X

X

Several commenters inquired about the notification process for disputes. Commenters suggested that the system notify the manufacturer by email immediately when a dispute is made. Commenters also requested that the physician be notified by email if a dispute is marked as resolved or dismissed. Another commenter requested that all physicians be notified, not just those registered in the system prior to publication.

Thank you for the comment. The system as designed will notify manufacturers by email when a dispute has been initiated, or withdrawn. The system will notify physicians by email when the dispute has been acknowledged as well as resolved. However, in order to be notified of any activity in the Open Payments system, physicians must be registered in the Open Payments system.

13

Set dollar limit for disputes that are reported

X

Commenters recommended that low (de minimis) data that is disputed not be published as disputed. The commenters were concerned that items of such low value would be too costly for the manufacturer to properly investigate and resolve, and would lead to all de minimis data being published as disputed.

Thank you for your comment. This question is outside the scope of PRA. However as stated in the final rule, "we intend to monitor the volume and terms of disputes and resolutions, and plan to provide additional guidance regarding situations when the cost of resolving a dispute may outweigh the benefits."

14

Provide graphical user interface (GUI) and data import methods

X

X

One commenter requested that both graphical user interface (GUI) and data import methods be available for data submission.

Thank you for your comment. This suggestion is outside the scope of PRA; however, the system as designed allows both GUI and data import methods for data submission.

15

Allow research institutions ability to register

X

A commenter requested that research institutions be allowed to review and dispute research payments or other transfers of value made indirectly to covered recipients wherein the research institution is the initial recipient.

Thank you for your comment. This question is outside the scope of PRA since research institutions are not "covered recipients" as defined by the final rule.

16

Redundant system for registration

X

X

One commenter did not like that the new system requests many fields of information in order to register which has already been requested by other CMS registration systems. The commenter suggests integrating with other CMS systems in order to make registration simpler.

We appreciate the comment. We have leverage existing enterprise-wide shared services such as Enterprise Identity Management (EIDM) solution in order to minimize physician burden.

17

Ability to dispute all data with one comment

TOULA BELLIOS: Same as #26? X

X

A commenter was concerned that a physician may choose to dispute one, multiple, or all records reported by completing one comment box.

We appreciate the comment and agree that physicians submitting comments on multiple disputes should ensure the comment field is populated so that they may provide applicable manufacturers and group purchasing organization with enough information to research the dispute. CMS will be providing sample language to help covered recipients describe their dispute. We will consider future enhancements that will allow the user to confirm that they want the completed comment box to be transmitted to one applicable manufacturer and group purchasing organization or multiple entities.

18

CMS to provide 3rd party adjudicator

X

X

X

X

A commenter suggested that CMS should provide a third party adjudicator to the dispute resolution process. Another commenter stated that only the actual physician or a relevant representative affiliated with a teaching hospital should be able to initiate and resolve disputes in the System. Another commenter stated that CMS implement an arbitration process in place to ensure resolution is reached by the manufacturer and covered recipicient.

Thank you for the comment. As stated in the final rule, we maintain that we (CMS) should not be actively engaged in mediating dispute resolutions and believe that the relationship exists between the manufacturer and covered recipient, so these parties should be involved in the dispute process, not CMS. All users of the Open Payment systems have the ability to delegates to user roles to individuals that are internal or external to their own organization, at their own discretion.

19

Allow alternate staff to perform review & dispute

X

X

X

X

X

Commenters requested that physicians be allowed to designate a third party to gather and dispute information on the website. Another commenter questioned whether the authorized representative of a physician covered recipient will be vetted by our system.

Thank you for the comment. The system as designed allows physicians to have one authorized representative. The physician covered recipient's authorized representative is "vetted" insofar as the physician covered recipient must nominate the authorized representative. Teaching hospitals may register up to ten users.

20

Association plans to instruct clinical research physicians to not resolve disputes

X

X

A few commenters noted that they will recommend to clinical research physicians to not resolve disputes, but instead mark incorrect data as "in dispute" and "leave it at that".

Thank you for your comment. This suggestion is outside the scope of PRA.

21

Concerns with the registration process for authorized representatives and officials

X

One commenter objected to the registration process requiring Authorized Officials and Authorized Representatives to provide personal information during registration. Additionally, the commenter requested information on how authorized representatives residing outside the United States should complete the registration process for Phase Two.

Thank you for your comment. This suggestion is outside the scope of PRA.

22

Attestation agreement concerns

X

X

One commenter objected to the requirement that an Authorized Official attest to five series of statements, when only one of the fields is contemplated by the final rule. Another commenter suggested that the attestation clause be excluded as a requirement for transactions that are in dispute.

Thank you for your comment. This suggestion is outside the scope of PRA.

23

Incorrect data due to system

X

X

One commenter requested the ability to report incorrect data due to database error, through no fault of the manufacturer.

Thank you for your comment. If an error submission is found, the manufacturer is able to submit a correction to the data at anytime. If a physician notices an error, the manufacturer and the physician should work together to submit the appropriate correction.

24

Privacy concerns for physicians

X

X

One commenter requested that CMS identifies the information that will be disclosed to the public so that physicians can take steps can minimize identity theft risks. The commenter also inquired whether there are special safeguards for physicians who have been the victim of identity theft. The commenter suggested that the website contain notices clarifying that physicians should minimize the amount of information they disclose.

Thank you for your comment. Comments regarding data disclosed during the physician registration process is outside the scope of PRA.

25

Ability for manufacturers to designate a dispute resolution and correction contact person

X

One commenter requested that CMS allow applicable manufacturers to designate within the system an individual or individuals to serve as the dispute resolution and corrections contact periosn.

Thank you for your comment. We will consider future system enhancement which will introduce a new user role for the manufucaturers to designate a point of contact for dispute and resoluvtion and correction. In the interim, CMS has provided clear instructions to manufacturers about which system role will be receiving dispute notifications from the system.

26

Encourage covered recipients to initiate disputes using the system vs. calling applicable manufacturers directly

X

X

One commenter requested that CMS encourage covered recipients to initiate disputes using the system vs. contacting the manufacturer directly. Another commenter disagreed, recommending that CMS encourage manufacturers and GPOs to offer covered recipients the opportunity to review payment data before the data is submitted to CMS.

Thank you for your comment. CMS plans to include clear direction to covered recipient on how they can initiate a dispute using the system. We will also stress that any disputes initiated outside of the system will not be tracked by CMS.

27

Instances may occur when there is no resolution to a dispute

X

One commenter requested that CMS acknowledge that there are certain disputes for which resolution may not be possible.

Thank you for your comment. This suggestion is outside the scope of PRA.

28

Ability for covered recipients to submit a comment on a record without submitting a dispute.

X

One commenter requested that CMS reconsider the functionaility to comment on records that are not being disputed.

Thank you for your comment. We will consider this as a potential system enhancement in the future.

29

Ability for manufacturers to filter for records with disputes

X

One commenter requested that CMS allow the System to enable manufacturers to filter for records with disputes versus records with comments, so they can be managed with the appropriate priority.

Thank you for your comment. We will consider this as a potential system enhancement in the future.

30

Ability for manufacturers to flag a record as "resolved"

X

One commenter requested that the System allow manufacturers to flag a record as “resolved”, if direct contact with a recipient results in a mutual resolution and the recipient does not resolve the record on their end. One commenter also requested to enable a manufacturer to mark a resolved dispute as “resolved with no recipient response”.

Thank you for your comment. We expect that all disputes that are resolved, regardless of the mechanism in which those resolutions are reflected within the as "resolved" be done si in accordance with the guidance provided within the final rule.

31

Revisit term "dismissed"

X

X

One commenter requested that the System replace existing "dismissed" term with “resolved- with no change”, “resolved- with change”, “requested for withdrawal”, etc.

Thank you for you comment. We have addressed this issue in response to other comments received through this public solicitation.

32

Perform quarterly data updates

X

One commenter suggested that CMS conduct quarterly data refresh updates.

Thank you for your comment. This suggestion is outside the scope of PRA.

33

Resolution of disputes is not required

X

One commenter suggested that CMS educate covered recipients that dispute resolution is not required.

We appreciate the comment. This policy is outside the scope of this PRA solicitation.