CMS-10495_Response to 60-day Public Comments

Commenter
PhRMA

Comment
1. Overall Burden of Compliance. The actual
burden imposed on applicable manufacturers is
significantly higher than the estimates provided
by CMS.

2. Burden Associated with Dispute Resolution.
PhRMA comments the current CMS dispute
resolution period is inadequate. Additionally,
the cost of reviewing disputes could be more
labor intensive because researching a disputed
transaction could involve reviewing the original
transaction and supporting documentation and
contacting employees.

3. Limitation of CME Organizations to Five
Enumerated Organizations.

Response
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments. The
overall burden of compliance commented
by PhRMA relates to CMS-10419, Data
Collection and Submission of Transparency
Reports and Reporting of Physician
Ownership or Investment Interests, with
OMB control number 0931-1173.
The Open Payments system will facilitate
the process between covered recipients,
physician owners and investors, applicable
manufacturers and applicable group
purchasing organizations, however, CMS
does not estimate an additional burden
imposed on applicable manufacturers and
applicable group purchasing beyond
collecting and submitting payments or other
transfers of value to CMS. There is no
additional burden estimated because CMS
is not involved in the dispute resolution
process between applicable manufacturers,
applicable group purchasing organizations
and covered recipients or physician owners
or investors.
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.

4. CMS Should Exclude All Meals at Accredited
CME Events from Reporting.

5. Provision of Reprints to Covered Recipients
Should be Excluded from Reporting.

6. Recruitment Expenses Should be Excluded
from Reporting.

7. Payments to Physician Board of Directors at
Applicable Manufacturers Should be Excluded
from Reporting.

ACCME

8. ACCME requests CMS explicitly state that
payments or other transfers of value provided
as compensation for speaking at a continuing
education program emanating from: (1)
organizations directly accredited by the
ACCME, (2) organizations directly accredited
by the state medical societies recognized by the
ACCME as accreditors of CME within the
ACCME system, (3) organizations accredited
by the Accreditation Council for Pharmacy
Education, and (4) organizations accredited by
the American Nursing Credentialing Center
(ANCC) under the terms and conditions of the

This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.

AHCJ

PEW

Fred Trotter

AMA

Joint Accreditation offered jointly by the
ACPE, the ACCME and ANCC are not
required to be reported under this final rule.
9. The Association of Health Care Journalists
requests CMS release the data with unique
identifiers allowing the public and journalists to
more easily aggregated payments to individual
doctors. AHCJ urges CMS to assign a random
unique identifier to each individual payee.
10. The current estimate of three hours of total
support staff time for physician registration
should be reduced to 30 minutes.
11. The number of physicians who will register is
likely closer to 224,425 than to the current
estimate of 448,850.
12. The number of physicians who, after review,
will dispute the reported information will be a
fraction of the currently estimated 224,425.
CMS should reduce the number of physicians
expected to dispute information to 10,000 or
fewer to reflect the historically low levels of
such disputes.
13. Requesting CMS use a unique identifier for
each record. This should be a simple hash
from the NPI.

14. Requests a justification for requiring
physicians to register in Enterprise Identity
Management (EIDM) system prior to
registering in Open Payments.

This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
The estimate for physicians and teaching
hospitals registration is reduced to thirty
minutes.
The number of physicians registering is
reduced to 224,425.
The number of physicians reviewing
payments of other transfers of value is
based on public comments received during
the rulemaking process.

This comment is outside the scope for
CMS-10495, Registration, Attestation,
Dispute & Resolution, Assumptions
Document and Data Retention
Requirements for Open Payments.
Registration in EIDM prior to registering
for Open Payments is necessary for identity
proofing users in Open Payments.
Individuals with EIDM credentials (because
they accessed other application, which
required EIDM registration) are only

required to request access to Open
Payments.
15. Requests CMS to clarify that the submission of
phone numbers (business or personal) or
emails (business or personal), is voluntary,
and is not required to review Sunshine Act
consolidated reports, dispute the contents of
such reports, or secure corrections.
Furthermore, to the extent that physicians (or
their representatives) elect to receive
notifications, they should not be compelled to
provide more than one email or phone number
for such notifications. Further, CMS must
notify physicians in advance if the agency
takes the position that voluntarily submitted
information, such as email and phone
numbers, will be disclosed to the public based
on FOIA request or used for the other agency
government activities. The agency is also
required to notify physicians if it intends to
use such contact information for any purpose
other than the Sunshine Act Program.
To the extent physicians want to have CMS
notify or communicate with the physician or
the physician’s representative, CMS should
specify that physicians (and/or their
representatives) have the option of: (1)
logging into the online portal to obtain
information without notification (via email,
phone, or mail); or (2) selecting a method or
method(s) of notification. Further, CMS

Physicians are required to register in the
Open Payments system prior to reviewing
payments or other transfers of value
submitted to CMS by applicable
manufacturers or applicable group
purchasing organizations. The information
collected by physicians is necessary to
ensure payments or other transfers of value
submitted by applicable manufacturers or
applicable group purchasing organizations
are attributed to appropriate physicians.
CMS is only using contact information
submitted by physicians during registration
for purposes of Open Payments.

should urge physicians to carefully select the
method of communication or contact with the
agency.
16. CMS has underestimated the resources and
burden imposed on physicians to ensure
reports are accurate and fair.

The burden imposed on physicians during
the review period is based on public
comments received during the rulemaking
process.
17. The AMA strongly urges CMS to give
This comment is outside the scope for
physicians the opportunity, through the public CMS-10495, Registration, Attestation,
registry, to provide physicians with the option Dispute & Resolution, Assumptions
to provide comments on their public reports
Document and Data Retention
similarly to reporting manufacturers and group Requirements for Open Payments.
purchasing organizations.