HIT comment letter Stark CMS - McClellan ltr 12-12 -05 on…
Description
December 12, 2005 Mark B. McClellan, MD, PhD, FACP Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1303-P Room 445-G, Hubert Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201 Re: Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health Records Arrangements, 42 CFR Part 411, CMS-1303-P, (October 11, 2005) Dear Dr. McClellan: The American College of Physicians (ACP), representing over 119,000 doctors of internal medicine and medical students, appreciates the opportunity to submit comments on the proposed rule, “Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health Records Arrangements,” published in the Federal Register dated October 11, 2005. This proposed rule would establish new exceptions under the Federal Physician Self-referral Law for certain arrangements involving the provision of electronic prescribing and electronic health record (EHR) technology. We applaud CMS for its expediency in issuing a proposed rule and urge the final rule to be promulgated as soon as possible. We want to take this opportunity to acknowledge the importance of providing protections to entities considering the donation ...
Informations
| Publié par | Eddo |
| Nombre de lectures | 15 |
| Langue | English |
Extrait
December 12, 2005
Mark B. McClellan, MD, PhD, FACP
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1303-P
Room 445-G, Hubert Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
Re:
Medicare Program; Physicians’ Referrals to Health Care Entities With
Which They Have Financial Relationships; Exceptions for Certain Electronic
Prescribing and Electronic Health Records Arrangements, 42 CFR Part 411,
CMS-1303-P, (October 11, 2005)
Dear Dr. McClellan:
The American College of Physicians (ACP), representing over 119,000 doctors of
internal medicine and medical students, appreciates the opportunity to submit comments on
the proposed rule, “Medicare Program; Physicians’ Referrals to Health Care Entities With
Which They Have Financial Relationships; Exceptions for Certain Electronic Prescribing
and Electronic Health Records Arrangements,” published in the
Federal Register
dated
October 11, 2005.
This proposed rule would establish new exceptions under the Federal
Physician Self-referral Law for certain arrangements involving the provision of electronic
prescribing and electronic health record (EHR) technology.
We applaud CMS for its
expediency in issuing a proposed rule and urge the final rule to be promulgated as soon as
possible.
We want to take this opportunity to acknowledge the importance of providing protections to
entities considering the donation of electronic prescribing and EHR technology to other
entities struggling to come up with the financial means to make the investment.
We also
recognize the complexity involved with writing a rule that balances the need to speed
adoption of information technology with the need to protect patients from fraud and abuse.
We believe the Centers for Medicare & Medicaid Services (CMS) has made a good-faith
effort to draft a proposed rule that attempts to strike that balance and we congratulate you
on this effort.
However, we have significant concerns that the proposed rule does not
accomplish what it intends and, in some places, may create unintended consequences that
restrict the ability to adopt new technology in the future.
2
SUMMARY OF COMMENTS
•
ACP appreciates the efforts CMS has made in the proposed rule and we urge the
prompt and efficient release of the final rule.
•
Congress and the Administration must take a greater leadership role in offering
financial incentives to providers to accept the increased costs (one-time and
ongoing) and practice workflow changes (ongoing) required as part of HIT
implementation.
•
We are particularly concerned the proposed requirement for the Recipient to
“certify” technology poses an undue financial burden and should be either clarified
or withdrawn.
•
ACP requests flexibility in defining the criteria for “used solely” to avoid the
unbundling of multi-use devices, resulting in an added expense.
•
CMS should be as inclusive as possible when considering adding potential qualified
Donors and Recipients.
•
Permitted donations should be broadly interpreted to include any equipment
(especially hardware), item, information, right, license, intellectual property,
software, training, education or service necessary for developing, implementing,
operating or facilitating
the adoption of electronic prescribing or EHR.
•
We are not supportive of placing a cap or aggregate limits on the amount of
technology a Donor may provide.
GENERAL COMMENTS
ACP is well aware of the potential benefit of electronic prescribing and EHRs to the health
of Medicare beneficiaries -- and ultimately all Americans -- in terms of decreased medical
errors, increased clinical quality of care, and reduced costs for all stakeholders. We strongly
support overall efforts in Congress and the Administration to speed the adoption of uniform
standards for health information technology (HIT).
In particular, ACP supports the efforts
of the American Health Information Community (AHIC) and its confirmation of the
activities of the Certification Commission for Healthcare Information Technology (CCHIT)
to develop a process to certify specific HIT products that meet or exceed a specified level of
functionality, interoperability and security.
Within the College, we are firmly committed to providing practicing internists with
practical tools to help them improve quality and incorporate quality measures into their
practices.
ACP’s Physicians Information and Education Resource (PIER) provides ACP
members -- at no cost to them -- access to “actionable” evidence based guidelines at the
point of care for over 300 clinical modules.
ACP’s-own Practice Management Center has
developed resources to help internists in the decision-making process on electronic health
records and is leading an initiative to provide internists with tools and best practices to help
them redesign their office processes to improve health care quality.
While we believe the CMS proposed regulations represent a necessary step toward
facilitating the implementation of technology, we do not believe it will result in significant
3
widespread HIT adoption.
We do not believe the majority of potential Donors protected by
the proposed exceptions have the necessary financial resources to make a major impact
regarding implementation of this technology.
Without sufficient financial assistance from
the federal government, particularly to those in small physician practices, we will simply be
unable to achieve a smooth transition into a fully-integrated HIT society.
Therefore, we
believe it is essential to fund initiatives that encourage HIT integration into all health care
sectors.
To this end, ACP strongly believes that the Congress and the Administration must take a
more active leadership role by offering significant financial incentives for practitioners to
accept the increased costs and burdensome practice workflow changes that will be required
as part of HIT implementation. Such incentives should include grants, loans, and refundable
tax credits to account for the expensive start-up costs for implementation.
In addition, there
must be recognition of the on-going costs for training, maintenance and periodic upgrades
inherent in operating a HIT system.
These costs can be addressed by providing a modest
Medicare add-on payment for physicians who employ HIT as part of overall quality
improvement efforts. These same provisions can be found in the bipartisan legislation, H.R.
747, “the National Health Information Incentive Act.” In addition, we believe the
Department of Health and Human Services should act to expand the pay-for-performance
Medicare Modernization Act (MMA) Section 649 demonstration to encourage greater
participation from small physician practices.
We believe that offering meaningful financial
incentives is the most effective way to improve quality and expand the use of HIT,
especially in small practices.
While ACP does not believe the proposed rule will dramatically increase the overall
adoption of HIT, there are enough potential Donors with the financial means considering
this option and, therefore, several minor refinements and clarifications should be made in
order to yield the greatest possible benefit.
In order to have any amount of success,
however, it is absolutely essential that the Anti-kickback Statute safe harbors and the Self-
referral Law exceptions are completely in line with another.
ACP offers the following comments to the proposed rule:
SPECIFIC COMMENTS & RECOMMENDATIONS
“Necessary” Nonmonetary Remuneration (§ 411.357(v) and (w))
According to the proposed rule, the exceptions would not protect arrangements in which a
Donor provides items or services that are “technically or functionally equivalent to items
and services the Recipient currently possesses or has obtained.” In addition,
the proposed
rule would require the recipient to “
certify
” that the items and services to be provided are
not technically or functionally equivalent to items or services the recipient already
possesses or has obtained.
4
The College believes that the proposed criterion for “technical and functional equivalent” is
ambiguous and needs further clarification.
In an environment where advances in
technology are constant, this would be a very difficult standard in which to comply.
More
importantly, we are particularly concerned that the requirement to “certify” that the items
are not “technically or functionally equivalent to items or services the Recipient already
possesses or has obtained” will amount to an unnecessary and costly burden for physician
practices and other Recipients.
The vast majority of physicians will be unable to make such
a determination without hiring an outside expert in the informatics field with the requisite
knowledge.
Particular issues CMS needs to clarify in the final rule regarding the “certify” provision are:
What types of information should be included in the certification?
What are the penalties
for innocently misstating the technical or functional equivalency of the item or services?
Who decides if and to what extent the Recipient misstates the certification?
And, given the
technical expertise required to make this certification, CMS should also clarify if it is
appropriate to seek outside advice and whether those fees could be paid for by the Donor,
and applied to the aggregate limit or cap (should one be adopted)?
Given the multiple complexities and uncertainties surrounding the certification requirement
and ambiguity of items that are “technical and functional equivalent,” we strongly believe
the undue burden and added expense required runs counter to the intent of the MMA to
further promote the implementation of this technology.
ACP strongly recommends CMS
reconsider this requirement, or remove the obligation to “certify” altogether.
In addition, ACP seeks further clarification of CMS’s concern about the risk of Recipient’s
intentionally divesting themselves of functionally or technically equivalent technology that
they already possess to shift the costs to Donors.
We do not believe there is substantial risk
of intentional divesting technology, however, there may be innocent situations that unfairly
trigger a violation of the proposed rule.
For example, Recipients may have some form of
technology that, because of its inherent complexities, the practice is not using it to its full
potential.
A Donor that offers the Recipient a more “user friendly” system along with the
necessary training and supports – something the Recipient desperately needs in order to
recognize the technology’s full-use – should not be in violation of the rule, especially if the
Donor is aware of the situation.
In addition, there may be a situation where a Recipient relocates or is recruited by a Donor
to another geographic area.
In that case, if the Recipient divests all of its practice assets,
including technology, and accepts the Donors technology should that Recipient (or Donor)
be in violation of the law?
We believe CMS should clarify this restriction and draft a rule
that is more flexible.
Finally, CMS includes in the proposed rule “Necessary” definition examples of hardware,
software, broadband or wireless Internet connectivity, training, information technology
support services and other items and services used in connection with the transmission or
receipt of electronic prescribing information.
We recommend that this definition implicitly
include connectivity services, help desk services and operating system software.
Inclusion
5
of items such as these will support the optimum use of information technology while not
impinging on efforts to combat fraud and abuse.
“Used Solely” (§ 411.357(v) and (w))
The College seeks clarification of the requirement that items and services donated must be
“used solely” for the transmission or receipt of electronic prescribing information.
We
believe that narrowly proposed “used solely” criteria will limit the effectiveness of the
proposed rule to facilitate the implementation of HIT.
For example, many physicians are
currently dissuaded by the ‘business case’ and practice workflow changes necessary to add
electronic prescribing or other forms of technology to their practices.
In most practice
settings, single purpose electronic prescribing technology is of limited value.
While the
donation of requisite electronic prescribing hardware, software, and training may affect a
change in this position, the inclusion of increased functionality in the donated system (e.g.,
email capacity, Internet capability, etc.) would further facilitate increased participation by
Recipients.
Furthermore, the “used solely” requirement may have the unintended effect of pressuring
vendors to “strip-down” already integrated software packages, a practice known as
“unbundling,” resulting in less office efficiency and ultimately increased practice costs
arising from the need to purchase additional technology separately. We are, therefore,
requesting consideration of protections that cover increased functionalities in the donations.
This would be consistent with the proposal to create an additional exception to protect the
provision by Donors to Recipients of some limited hardware (including necessary operating
system software) and connectivity services that are used for more than one function, so long
as a substantial use of the item or service is to receive or transmit electronic prescription
information.
Finally, while ACP greatly appreciates CMS elaborating on what qualifies as “used solely”
to a broader “substantial use” definition as it applies to limited hardware and connectivity
services, we still believe that even this term would benefit from further clarification.
In
order to avoid percentages or other confusing criteria, we recommend CMS allow for more
flexibility in allowing multi-purpose devices.
Comments on Other Qualifying Technology
CMS is soliciting comments on whether the exceptions should protect qualifying electronic
prescription technology that is used for the transmission of prescription information
regarding items and services that are not drugs (e.g., supplies or laboratory tests).
ACP
strongly supports the expansion of exceptions to protect prescription information on items
and services that are not drugs.
We believe these can include prescriptions for laboratory
tests, supplies and durable medical equipment (DME).
Other Donors and Recipients Protected by the Exceptions
6
The College strongly supports the expansion of the exceptions to include other categories of
Donors and Recipients within health care that can facilitate the implementation of
electronic prescribing and EHRs. We understand CMS was simply responding to the
drafting of the MMA legislation and we hope broadening the scope of qualified Donors and
Recipients will be received favorably.
We are also aware that Section 1877 of the Act
restricts CMS to regulatory authority over physicians, we do believe, however, non-
physicians and other health care providers should be excluded from protection.
Specifically, we recommend the inclusion of clinical laboratories and other types of health
care providers such as nursing homes, durable medical equipment (DME) providers,
community health centers, and other long term care facilities as potential Donors and
Recipients of this technology. The College also supports the inclusion of certain other
provider organizations, such as Network Providers or other entities that operate, support or
manage Network Providers; physician-hospital organizations or physician organizations;
Regional Health Information Organization (RHIOs), or others designed to enhance the
overall health of the community.
Another area that needs further modification involves the requirement that hospitals can
only donate technology to physicians on its own medical staff.
This strict requirement runs
the risk of the hospital providing technology to only certain members of a group practice,
potentially isolating other “members of the group practice” who do not have privileges to
the Donor hospital.
In order to promote continuity of care and avoid a situation where only
part of a practice is wired, we believe Donors should be allowed to donate technology to all
“members of a group practice,” including those who do not routinely provide services to the
Donor.
We believe that as long as other safeguards are in place to not otherwise impose
barriers to compatibility, there is little risk of fraud or abuse.
(
It should be noted that this
area will also come into play as Donors incorporate selective donation criteria
).
Similarly, we believe a group practice should be able to provide technology to “independent
contractors” providing services within the group or persons who are not physicians.
In
many cases, especially in emergencies, other providers within the group practice may cover
for independent contractors in their absence and it makes sense that all records of patients
are readily available to the practice, regardless of the status of the treating provider.
In sum, ACP strongly believes that in order to facilitate the distribution and implementation
of electronic prescribing and EHR technology, the definition of Donors and Recipients
should be drafted as
broadly and inclusively as possible.
It is unfair to permit certain
Donors to provide technology, but restrict other providers from providing that same
technology.
We do not believe this was the intent of the Congress in drafting this
provision, and therefore, recommend CMS broaden its definition.
Proposed Pre-and-Post-Interoperability EHR Exceptions (§411.357(w) and (x))
The pre-interoperability and post-interoperability exceptions would at least protect
electronic health records software (that is, software that is essential to and used solely for
the transmission, receipt, and maintenance of patients’ electronic health records and
7
electronic prescription drug information) and directly-related training services, provided
that the software includes an electronic prescribing component
.
ACP requests that the
elements covered by the exception for EHRs be further clarified and expanded.
More
specifically, it is unclear from the proposed rule whether the donated costs of an EHR
system operating within an Application Service Provider (ASP) model would be covered by
the exceptions. We seek clarification here.
Furthermore, it is unclear whether the “help desk” or the consultation that is routinely
required with the implementation of an EHR system within a practice is covered by the
proposed exceptions.
This service is vitally important to the success of implementation. It
is also not clear whether clinical decision support technology (e.g., PIER) is included under
the proposed exceptions. We believe that this type of clinical decision support technology is
an important element in any effective EHR system and should be covered by the
exceptions.
Finally, the College strongly suggests that permitted donations be broadly expanded to
include any equipment (especially hardware), item, information, right, license, intellectual
property, software, training, education or service used for developing, implementing,
operating or facilitating
the adoption of EHR and other HIT and the electronic exchange of
health information by physicians and other health care providers. In addition, we favor
CMS take the position requiring all donations meet or exceed the CCHIT-approved
certification levels of functionality, interoperability, and security
.
We believe that the
significant benefits of facilitating implementation of technology by including this broad
category of CCHIT-certified donations within the exception far outweigh the potential for
increased abuse.
Selective Criteria (§411.357(x)(4))
CMS is proposing that neither the eligibility of a recipient to receive items and services
from a protected Donor, nor the amount or nature of the items or services received, may be
determined in a manner that takes into account the volume or value of the recipient’s
referrals or other business directly generated between the parties. The proposed rule further
clarifies that this exception does not preclude selection criteria that are based upon an
indirect measure of business generated by the recipient (e.g., the total number of
prescriptions written by a recipient of electronic prescribing hardware or software).
The College supports the need to exclude from the exception donations that are a condition
of doing business with the Donor, or are a direct result of the volume or value of the
amount of business generated by the recipient to the Donor. We are concerned, however,
about the further elaboration that permits selection based upon indirect measures of
business generated. We believe that most Donors will employ such selection criteria that
will potentially disadvantage small physician practices -- which generate relatively limited
business – in competing for donations included in the proposed exceptions.
We suggest
that the proposed rule include incentives for donations covered by the exception to promote
donations to small (especially in rural and underserved) practices.
8
Value of Protected Technology
ACP is greatly concerned about limitations on the aggregate fair market value of all items
and services provided to a Recipient from a single Donor and the belief that a monetary
limit is appropriate and reasonable to minimize the potential for fraud and abuse. First, we
do not believe the risk for fraud and abuse is high and, more importantly, we believe that
setting such limits would unnecessarily discourage potential Donors from providing
technology.
The College questions the need for caps or aggregate limits to be placed on donated
technology to meet the requirements of the exceptions.
There is real question as to how
such limitations would implemented, calculated, monitored, and adjusted from year-to year.
A more basic question, however, is whether the standard to be used for calculating the cost
would be the
fair market value
to the Recipient, or what the
actual cost
is to the Donor,
keeping in mind large Donors would be able to leverage economies of scale by buying in
bulk.
In addition, the per-physician implementation cost to a small physician practice will
be much higher than for a medium-to-large physician practice.
Therefore, setting a per-
physician cap or limitation could greatly disadvantage the smaller practice and limit their
overall eligibility.
It also should be noted that donation value involves many other
variables that CMS should consider.
For instance, there are fees for software licenses, IT
support and training, processing, implementation, hardware, connectivity, and other
elements.
So, if CMS is inclined to adopt a cap or aggregate limitation, we urge
consideration of all the expenses (initial and ongoing) involved.
While we recognize CMS’s fraud and abuse concerns, we believe the proposed rule already
contains sufficient protections that alleviate the need for a cap or aggregate limits.
The
placement of a cap or aggregate limitations would only serve to stifle the implementation of
electronic prescribing and EHR technology. We are particularly concerned that a cap,
without proper consideration of all the variables, will significantly disadvantage smaller
practices that need the most financial assistance.
We, therefore, do not believe a cap is
warranted or necessary at this time.
Definitions of ‘Interoperability’ and ‘Electronic Health Record’
ACP supports CMS’s use in the proposed rule of “interoperability” as “the ability of
different operating and software systems, software applications, and networks to
communicate and exchange data in an accurate, secure, effective, useful, and consistent
manner.”
We believe this proposed language sufficiently defines the term.
The College suggests, however, that you reconsider the use of the term “electronic health
record (EHR).” This term, as used in the proposed rule, is inconsistent with terminology
used within the information technology industry and, its use to refer to several different
concepts, is confusing to the reader. An EHR typically refers to the broad concept of the
sum total of all the health care data that exists regarding an individual within the electronic
universe. This may include an individual’s personal health record, their history of
9
medication use stored by a drug plan, medical records electronically stored by their primary
physician, electronically stored imaging results stored in the local hospital etc. An EHR
system refers to any system (e.g., e-prescribing, electronic medical record, personal health
record) that is a component within the individual’s EHR. An electronic medical record
(EMR) system typically refers to patient-centric, electronically maintained information
about an individual's health status and care that focuses on tasks and events directly related
to patient care, and is optimized for use by clinicians. It is also limited in scope to the
continuum of care within a single clinical delivery system. This EMR system definition is
based upon a definition offered by the Gartner Consulting group for a computer-based
patient record (CPR). In most instances throughout the proposed rule, we believe you are
technically referring to an EMR system rather than an EHR, however, the final rule should
make a clarification.
CONCLUSION
While we commend CMS for submitting a proposed rule allowing the promotion of
electronic prescribing and electronic health records, we strongly urge the OIG and CMS to
make the necessary clarifications and promulgate the final rule as expeditiously as possible.
Donors and Recipients need to have the necessary comfort to engage in these types of
arrangements and the final rule should do nothing to discourage such engagements.
Again, ACP greatly appreciates this opportunity to comment on the proposed standards.
Please do not hesitate to contact Neil Kirschner, Ph.D., Senior Associate, at (202) 261-4535
and
nkirschner@acponline.org
or Patrick Hope, Esq., Legislative Counsel, at (202) 261-
4541 and
phope@acponline.org
if you have any questions regarding these submitted
comments.
Sincerely,
Joseph W. Stubbs, MD, FACP
Chair, Medical Service Committee
© 2010-2024 YouScribe