September 8, 2015
The Honorable Andrew Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attn: CMS-1631-P
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
Re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other
Revisions to Part B for CY 2016; Proposed Rule (CMS-1631-P)
Dear Acting Administrator Slavitt:
The American College of Rheumatology, representing over 9,500 rheumatologists and health
professionals, appreciates the opportunity to comment on the 2016 Medicare Physician Fee
Schedule Proposed Rule. After careful review, we are providing comments and recommendations
relating to several key provisions. We look forward to working with your team on these issues.
As you know, rheumatologists provide ongoing care for Medicare beneficiaries with complex
chronic and acute conditions that require expertise beyond that of primary care providers.
Rheumatologists provide face-to-face, non-procedural care, and serve patients with serious
conditions that can be difficult to diagnose and treat, including rheumatoid arthritis and other
debilitating and potentially disabling rheumatic diseases. Early and appropriate treatment by
rheumatologists can improve outcomes and prevent costly procedures.
The viability of providing this care for Medicare beneficiaries must be protected. The ACR is very
concerned about growing shortages of rheumatologists. These workforce shortages may become
more acute because of the increasing population of Medicare beneficiaries who will need
rheumatology care and the influx of patients resulting from the Affordable Care Act. If the
expertise rheumatologists and other cognitive specialists bring to their patients is not
valued appropriately, then the numbers of rheumatologists and other cognitive specialists
will be inadequate to meet the growing demands for these services, restricting Medicare
beneficiaries’ access to appropriate health care.
Evaluation and Management (E/M) Codes; Improving Payment Accuracy for Care
Management Services
We sincerely appreciate CMS’s attention to E/M codes and ways to better recognize and
compensate for care management services. We especially appreciate the agency’s interest in ways
to recognize the different resources, particularly in cognitive work, involved in delivering broadbased, ongoing treatment. As such the ACR fully supports CMS’ proposal to create add-on codes to
reimburse currently uncompensated physicians work associated with E/M services as a practical
and expedient solution to the undervaluation of E/M services.
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We appreciate that CMS is framing possible solutions to properly compensate cognitive work and
recognize that it is broader and more specialized than primary care. We would note that a higher
valuation of E/M codes would be another way of resolving issues faced by rheumatologists and
other cognitive specialists.
The ACR recommends that the definition of any newly created codes should be specific and not
overlap with existing codes, and that the methodology for assigning codes should be clearly
explained to avoid misinterpretation and poor implementation. The setting where new codes can
be used by rheumatologists should be clearly delineated and simple to follow. For some of these
codes, the rules under which providers are able to claim that code, such as those related to
plurality of care, should be clearly stated to enable rheumatologists to determine if they qualify in
that instance.
We strongly recommend that new add-on codes be developed for use by all specialties, and
they should not be restricted to certain specialties. As an example, there should be two
categories of add-on codes for both new and established outpatients that reflect the different levels
of intensity of the work performed: the first for a high level of intensity, and the second for a yet
higher level of intensity. These codes should follow the resource-based paradigm of RBRVS using
work intensity as the unit of resource use. For primary care, the levels of intensity would recognize
both the complexity, such as the evaluation of the multiple drug interactions in patients taking
numerous medications and the various co-morbidities, and the high level of post-visit work
intensity for patients with several different chronic conditions requiring management. For the
specialist, the levels of intensity would recognize the complexity of a disease and the complexity of
the medical decision-making, which often requires consideration of multiple interventions across
different organ systems.
More Research Needed in Order to Understand E/M Services
While we appreciate CMS’ proposal to compensate physicians for this currently uncompensated
work and view this proposal as an important first step, it does not go far enough. New payment
models being studied and implemented by CMS continue to rely on the resource-based relative
value scale (RBRVS) when determining physician compensation. Yet, the existing E/M codes
continue to be improperly defined and valued. The inequities faced by physicians whose work
consists of providing these services in the fee-for-service model will persist in new payment
models until CMS addresses these service codes.
Specifically, there continues to be much variability in the work completed by different specialties
within the existing E/M service codes and there continues to be a wide range of post-service work
completed as a result of the encounter by different specialties. Some are relatively overpaid and
some are relatively underpaid. There are too few basic choices. We and our partners previously
proposed that CMS improve the accuracy in the Physician Fee Schedule by creating new E/M codes
that would be developed from a knowledge-base that reflects current levels of physician work
based on nationally representative samples and electronically accessible data. If successful, this
research-based model could then be used to address deficiencies in the other E/M code families.
We urge CMS to commit to performing this research and to hire a contractor that will work
with stakeholders to develop a comprehensive understanding of what physicians and their
clinical staff do on a daily basis. We believe that the section 3021 of the Affordable Care Act
provides the Innovation Center with the authority to conduct this research. As long as new payment
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models use the RBRVS as the foundation for physician reimbursement, E/M services must be
revised to accurately reflect the work provided to patients. More accurate reimbursement for
cognitive work has the potential to enhance the quality care provided to patients while lowering
costs, both goals of Innovation Center projects.
This research we request would 1) describe in detail the full range of intensity for E/M services, 2)
define discrete levels of service intensity based on this observational and electronically stored data
combined with expert opinion, 3) develop documentation expectations for each service level that
place a premium on the assessment of data and resulting medical decision making, 4) provide
efficient and meaningful guidance for documentation and auditing, and 5) ensure accurate relative
valuation as part of the PFS.
While we urge CMS to commit to the research necessary to develop new E/M codes, we believe that
this research will also be critical to identifying and valuing the uncompensated work associated
with E/M services that the agency intends to support with the add-on code proposal. This research
will provide the agency with an accurate and reliable description of E/M activities. It will also help
clarify what physician work should be attributed to the E/M services and allow a clear definition of
what Medicare should expect from chronic care management (CCM) and transitional care
management (TCM) services.
Establishing Separate Payment for Collaborative Care
We support CMS’ proposal to reimburse physicians for collaborative care since the existing E/M
services do not reimburse for the services provided in this context. This proposal would address
the serious gap in reimbursement that has existed since the elimination of the consultation codes.
As CMS considers how to operationalize this proposal, we are concerned about the imposition of
potential health information technology requirements. If these requirements are too burdensome,
they could prove to be too challenging for small practices and solo practitioners. We recommend
that primary and collaborating physicians be able to share clinical data and electronic health
records, with no requirement for full data transparency. As patients become more concerned about
privacy and EHRs become more proprietary, full transparency is an unreasonably high standard.
We also recommend that patient liability be waived for all physicians who provide collaborative
care, extending beyond those participating in certain Innovation Center projects. Increasing access
to specialty knowledge and to decision support will improve the accuracy of the primary
physician’s medical decision making and improve efficiency by eliminating the wait to incorporate
specialized care recommendations as part of a patient’s health plan.
Changes to Chronic Care Management Payment / New Code Recommendations
Rheumatologists by virtue of the nature of their specialty practice should be a prominent user of
the Chronic Care Management (CCM) payment. However, several requirements for the CCM
payment are still too onerous for most rheumatologists, reducing their participation in this
program. The requirement for 24-hour coverage alone makes this payment not feasible for most
rheumatologists. Modifications should be made to allow most rheumatologists and rheumatology
practices to utilize the code. The ACR proposes CMS pursue further changes in the eligibility
requirements for the code, in order to allow appropriate recognition of chronic care management
services provided by rheumatologists and rheumatology practices.
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We welcome CMS’ proposal to refine the complex chronic care management (CCM) and transitional
care management (TCM) services that are currently underutilized. We view this effort as continued
progress towards promoting accountable care for patients but believe more work needs to be done
to adequately capture the work performed and to promote care coordination between physicians.
However, as structured, the administrative requirements of these codes are not commensurate
with the reimbursement of approximately $42.
The current use of time metrics for code documentation is inefficient and impractical. The
experience with care management indicates that typically multiple short phone calls involving
multiple providers and the patient are made each month. A less onerous method of logging and
timekeeping than currently employed would be a great improvement.
The care management needs of beneficiaries vary considerably from month to month. The average
might be 20 minutes per beneficiary per month, but there are some months where a 5-minute
phone call is all that is necessary to assure a patient is stable. There are other months where an
hour or more of telephone contact will be required to resolve diagnostic and treatment issues and
ensure appropriate management when the manifestations of these chronic diseases and their
complications are evolving between regularly scheduled appointments. The requirement of 20
minutes per beneficiary per month imposes an unrealistic expectation that will foster unnecessary
phone calls and documentation and divert attention and resources away from the care of those
patients who require more intensive intervention.
We recommend that CMS eliminate the 20 minute per month requirement and replace it
with a standard that better reflects a patient’s care management needs each month. This
could be a temporary requirement until a database could be developed to serve as the foundation
for revisions to this service and the development of future similar services. CMS should also
consider adopting the CPT code for more complex patients with its higher reimbursement level.
In summary, as structured not only do these codes create unrealistic administrative burdens,
but they are also unworkable for most rheumatologists. We ask CMS to remember that many
specialists engage in the chronic care management described by these codes and ask that CMS
undertake revisions to these service codes in order to promote their use by these specialists
primarily engaged in this variety of continuous cognitive work.
New Code Recommendations
We appreciate the agency’s attention to developing codes for activities that physicians, or clinical
staff, are performing but for which they are not being paid. We thank CMS for recognizing that
physician specialties and similar stakeholders are best positioned to provide suggestions for new
codes. Establishing new codes in 2017 will allow physicians to gain experience with them and
be better able to use them as they transition to new payment models. Generally, given the
limitations of electronic health records, especially in regards to interoperability and the ongoing
controversy over meaningful use, we do not support technology requirements for practice
eligibility for any new codes or models. CMS should also consider creating “intensity” codes where
current codes do not capture the intensity of a service in some situations.
The ACR recommends that CMS a) pay for informal consultation, non-face-to-face care coordination
as contained in existing CPT codes 99446-99449; b) pay for prolonged non-face-to-face services as
contained in existing CPT codes 99358 and 99359; c) create a new code for multidisciplinary clinic;
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d) create a CCM-like code for specialists who monitor and manage chemo/immunotherapy; e)
create a collaborative care code for specialists even if not on chemo/immunotherapy; and f) pay for
prolonged non-face-to-face pre or post visit.
In developing these codes, CMS should create criteria and standards such that the codes do not
overlap with existing codes. For example, for non-face-to-face codes like CCM, CMS should make it
clear that the services goes well beyond any non-face-to-face time or work in the existing E/M
codes. Many of the new codes may require patient-specific criteria such as illness severity criteria;
requirements for specific activities on the part of the physician or clinical staff; and minimal time
requirements for physician and/or clinical staff.
Specific Code Proposals
Use of Existing CPT codes – There are two areas for which CMS should recognize existing CPT codes.
a. Informal inter-professional consultation - 99446-99449: There are existing CPT codes for these
services, which have been valued by the RUC. CMS should consider recognizing these codes and
making payment for them.
b. Prolonged non-face-to-face Services - 99358 and 99359: These codes exist to account for
extensive medical record review or extensive pre and post E/M time that is non-face-to-face.
CMS should begin making separate payment for these codes, specifically to recognize these
services. We and our partner societies would be happy to work with CMS to develop payment
policy parameters around patient complexity, extent of record review, etc., in order to facilitate
accurate reporting of these codes.
Creation of New Codes
c. Multidisciplinary Clinic: There are a number of clinics at which physicians of different
specialties see patients simultaneously and share the history taking, physical examination and
medical decision making. This is an emerging care model; examples include a musculoskeletal
clinic with rheumatology, orthopedics and physiatry. There may also need to be staff
requirements CMS should consider. Individual codes for each physician would be unwieldy,
hard to value correctly, and would not accurately describe this new care model. CMS should
create a new code specific to this model and a modifier (conceptually similar to the co-surgery
modifier 62) where each physician would bill the same code and include the new modifier.
The payment would be split among the physicians based on fixed payment policy (e.g., if three
physicians report the code and modifier for the same patient, each physician would be paid
33% of the total). This code is different from a team conference as the patient is present and
medical decisions are being made and implemented. The code would only be paid if two or
three physicians report it; more than three physicians could be unwieldy. We also recommend
there be two codes: one for new patients and one for established patients. While it is possible
that two or more levels of service will be needed, as a start a single code describing this service
is appropriate and this code should be valued by the RUC.
d. Episode of Care Code for Managing Patients on Chemotherapy or Immunotherapy: This service
is not CCMS; the staff mix is different and the focus is on a single problem and a course of
therapy. This code would not be specialty-specific, but may need the service to be reimbursed at
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different levels. We recommend including specific physician and staff time requirements and
specific activities (e.g., phone calls, education calls, etc.) to differentiate from pre-service and
post-service of chemotherapy administration codes. This code would be for specialists and
would be different from the collaborative care codes (see below) because of the need for the
patient to be on a course of chemo or immune therapy. Collaborative care codes would not be
allowed if this code were billed.
e. Collaborative Care Code(s): This code group would be conceptually analogous to CCM but
enable specialists and primary care to split the payment when CCM is divided up between the
specialist and primary care provider. For example, an appropriate instance where this code
might be applied would be when a specialist is managing an illness related to specialty care and
interacting with a primary care provider who handles other aspects of the patient’s care –
coordination of care between these two physicians and co-management. In this way, it would be
possible for the specialist to bill for collaborative care and the primary care provider to bill for
CCM. This code would capture the non-face-to-face work of coordinating care (e.g., physician
communication behind the scenes) and optimizing management, potentially avoiding
unnecessary medical costs such as hospitalization.
To qualify for this code (unlike the Episode of Care Code above), the patient under the care of a
specialist would not need to be receiving active treatment, such as chemotherapy or
immunotherapy. The underlying requirement is that the patient has an active disease managed
by the specialist, while the rest of the patient’s care is provided by the PCP. Code descriptors
should be developed, possibly one for the specialist and one for the primary care doctor. In this
case, the use of these codes would supersede billing through CCM.
f.
Codes for management of acute illness remotely: These codes would be applicable in cases such
as home-care and assisted living, where the provider spends a great deal of time interacting
with clinical staff, family and others. Many patients are managed at home or in a non-facility site
of service for significant acute illness where non-face-to-face care is significant and goes well
beyond the pre and post service work of an E/M that happens during the course of the illness.
These codes would not be specialty or site specific. Duration could be set at 14 days, for
example. The code would include on-call care, but on-call care only may or may not be
sufficient. This code could perhaps be an add-on code for a face-to-face encounter would be
required. These codes’ applicability would be very discrete and should be easy to distinguish.
We would note that CMS telemedicine rules are strict and would prohibit payment for most of
the services contemplated in these new codes.
MACRA Provisions
CMS has requested input on a number of provisions of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA). We understand the agency plans to disseminate a Request
for Information later this year seeking comment on a much broader range of issues surrounding
MACRA implementation.
Low-volume threshold: CMS must decide whether to set a threshold for the number of Medicare
patients a physician must have in order to be subject to MIPS. The ACR would support 10% as a
minimum threshold in order to reduce administrative burden to those practitioners who do not
serve many Medicare patients.
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Clinical practice improvement activities: One of the categories that will be used to calculate MIPS
performance scores is clinical practice improvement. The MACRA specifies certain types of
activities such as expanded practice access, population management, and care coordination. The
ACR strongly recommends that, in order to incentivize providers to participate in Qualified
Clinical Data Registries (QCDRs), participation in such registries should be included as a CPI
activity. Additionally, CPI should not be limited to activities such as maintenance of certification.
We also request removal of elements of redundancy across the programs (i.e., clinical quality
measures (CQMs) should not be a part of MU, when they are already heavily incorporated in PQRS).
Finally, we request that CMS recognize that patient safety and practice assessments can also be
satisfied by the use of a QCDR.
Alternative Payment Models: CMS seeks input on how to implement MACRA's alternative payment
mechanisms (APMs), which cover patient-centered medical homes, accountable-care organizations,
and payment bundling. Physicians who receive a certain percentage of their revenue through APMs
will receive a 5% bonus each year from 2019 to 2024. The specific code proposals in this letter are
critically important for the transition to alternative payment models, as important as TCM and CCM.
Establishing new codes in 2017 will allow physicians to gain experience with them and be
better able to use them as they transition to new payment models.
Potential Expansion of Comprehensive Primary Care Initiative
We understand that CMS is not proposing an expansion of the Comprehensive Primary Care
Initiative demonstration at this time, but is requesting comments on issues related to a possible
expansion. The CPCI is a four year multi-payer pilot that seeks to strengthen primary care by
offering population-based care management fees and shared savings opportunities to participating
health providers. Through the CPCI, the CMS Innovation Center is testing the impact of
collaborating with 38 other private and public payers to better coordinate care for Medicare
beneficiaries by providing population-based care management fees and shared savings
opportunities for approximately 480 primary care practice sites in seven markets.
The ACR recommends that the CPCI should be expanded to include cognitive specialists. There are
potentially more savings to be captured with the inclusion of cognitive specialists like
rheumatologists, because they deliver care to patients with complex, multi-organ system
diseases.
Appropriate Use Criteria for Advanced Diagnostic Imaging Services
We understand that by law CMS must develop a new program requiring physicians and
practitioners to consult certain appropriate use criteria (“AUC”) when ordering advanced
diagnostic imaging services in certain settings. CMS is required to specify appropriate use criteria
from among those developed or endorsed by national medical professional specialty societies and
provider-led entities. CMS is also required to approve clinical decision support mechanisms; collect
additional information on the Medicare claim form; and use claims information to develop a prior
authorization program. In addition, CMS proposes to establish a process to identify clinical areas of
priority, specify appropriate use criteria, and lay out a timeline to accomplish these goals.
Beginning January 1, 2017 ordering professionals will be required to consult with a listed qualified
clinical decision support (CDS) mechanism when ordering an applicable imaging service and the
ordering professional must include on the claim the fact that a qualified CDS was consulted. As part
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of this program, CMS will also develop a mechanism for identifying outlier professionals. Outlier
professionals will be subject to the prior authorization requirements beginning in January 2020.
CMS proposes to focus the identification of outlier professionals on priority clinical areas, which are
yet to be defined. We strongly support restricting AUC development to national professional
medical specialty societies and provider-led groups.
The ACR recommends that if a provider is going to be required to follow guidelines or AUC,
and those guidelines or criteria are developed by internationally-accepted methodologies,
then the provider should not have to complete prior authorizations related to that
treatment. If a provider is using a drug in an on-label capacity for treatment guidelines, then there
should be no prior authorization required. These practical changes would decrease unnecessary
and wasteful administrative burdens, and as a result, increase efficiency and time spent with
patients. In cases for which the provider is following accepted AUC, the documentation for
guideline adherence should be simple and easy for the provider to provide at the time of care.
Telehealth Initiatives
CMS has proposed expanding the list of CPT codes for covered Medicare telehealth services
beginning in CY 2016 to include certain prolonged service and ESRD–related service CPT codes.
CMS also proposes to add Certified Registered Nurse Anesthetists (“CRNAs”) as authorized
telehealth practitioners. The ACR supports the concept of telehealth to allow for follow-up care
in particular for patients who because of their geography may not have easy access to followup visits. Access to care is a particular issue for children with rheumatologic diseases, many of
whom have to travel significant distances for an office visit. Notably, there are only 250 boardcertified practicing pediatric rheumatologists in the United States to care for the 300,000 children
who live with juvenile arthritis. In addition, the ACR feels strongly that rheumatologists should be
paid appropriately for other telehealth services that facilitate the delivery of specialty care. .
Potentially Misvalued Codes
We understand that the ACA instructed CMS to identify “misvalued codes” in the Physician Fee
Schedule. Congress had set a target for adjustments to misvalued codes in the fee schedule. For
calendar years 2017 through 2020, the target is 0.5% of the estimated expenditures under the PFS
for those four years. Subsequently, the Achieving a Better Life Experience Act of 2014 accelerated
application of the target by specifying it would apply for calendar years 2016 through 2018, and
increasing the target to 1% for 2016. CMS is proposing a methodology for the implementation of
this provision, which includes rules how net reductions in misvalued codes would be calculated.
Based on that methodology, CMS has identified changes that achieve 0.25% in net reductions. CMS
proposes 118 codes as potentially misvalued codes that were identified using the high expenditure
screen under the statutory category, “codes that account for the majority of spending under the
PFS.”
The identified potentially misvalued codes that would have impacts on rheumatologists, if cut, are
some of rheumatology’s high-expenditure codes. We would appreciate insights into the way CMS
determines which codes need to be revalued. We strongly believe that this determination
should not be made solely because codes are expensive; there should be some indication of a
component that appears to not be valued correctly. Arbitrary cuts solely on the basis of expense
are not appropriate.
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The identified codes have been through the normal RUC Five Year review process and we have
concerns that there is no transparency regarding how the codes were identified as potentially
misvalued. We do not agree with CMS' reliance upon the identification of codes through processes
that are not clear. This process to automatically review these codes without providing a mechanism
for validating the CMS resource-use data can have negative impact on the process. The ACR will
continue to work through the AMA’s Relative Value Scale Update Committee (RUC) to address
concerns with these proposed changes.
Open Payments Data
CMS is seeking comment on adding the Open Payments data to individual eligible professional (EP)
pages in Physician Compare to the extent it is feasible and appropriate. The ACR strongly cautions
against including Open Payments data on individual EP profile pages until additional
measures are implemented to ensure accuracy of the data, and until there are positive
changes to the onerous physician review and appeal process. CMS should include appropriate
contextual information that indicates that physician interactions with industry are often
appropriate and serve to advance medical knowledge and physician knowledge.
Medicare Opt-Out
Under the MACRA, Medicare opt-out affidavits will automatically renew every two years. Physicians
and practitioners would be able to rescind their opt-out status if they notify CMS at least 30 days
prior to the start of the next two-year period. Appropriately, this proposed rule will allow for the
automatic renewal of Medicare opt-out affidavits. The ACR supports this provision to reduce
unfair administrative burdens for practitioners who wish to opt out of Medicare.
Biosimilars Reimbursement / Part B Drugs
CMS proposes to update its regulations so that the payment amount for a billing code that describes
a biosimilar biological drug product is based on the average sales price (ASP) of all biosimilar
biological products that reference a common biological product’s license application. Biosimilars
that reference the same brand biologic would have a single billing code; i.e. multiple biosimilars to
the same biologic reference product would be grouped and issued the same J-code for Medicare
reimbursement purposes, receiving a single average sales price (ASP) and single Healthcare
Common Procedure Coding System (HCPCS) J-code that includes all corresponding National Drug
Codes (NDCs), following the same ASP calculation as for multiple-source drugs, but without the
inclusion of the reference product in the biosimilar ASP.
Biosimilars are not wholly reliable copies of an innovator drug-they are different products and not
generic copies of their reference product or other biosimilars that reference the same biologic
product. For the reasons outlined below, we strongly urge CMS to modify its proposal, so that
each biosimilar will have its own unique HCPCS billing code (J-code), unless the biosimilar is
deemed by the FDA to be “interchangeable” with the reference biologic.
a. Biosimilars are not generic drugs; they can only be similar to their reference product, not
identical like a small-molecule generic drug. Biosimilars, like all biologics, are large
molecules grown in living systems.
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b. Like any biologic, a biosimilar can trigger immune and other reactions in any given patient that
are unique to that product (and different from the branded biologic). In addition, each biologic
medicine possesses unique properties and sensitivities in manufacturing and handling, making
quick and accurate identification of accountable manufacturers imperative. To enable effective
traceability, each biosimilar must be fully distinguishable in all its names and tracking
codes, including HCPCS billing codes. The FDA’s draft guidance on nonproprietary naming of
biological products proposes distinguishable names, calling for biological products to bear a
nonproprietary name that includes an FDA-designated suffix. In addition, physicians and others
in the U.S. primarily rely on a non-biologic’s brand or nonproprietary generic name in reporting
adverse events.
c. The FDA is proposing distinguishable naming for all non-interchangeable biologics, an approach
with which CMS should be consistent in establishing HCPCS billing codes. The CMS proposal
also makes no provision for the approval of interchangeable biosimilars. In fact, by treating
biosimilars like generics, the proposal seems to treat all biosimilars for a given reference
product as interchangeable. Determinations of interchangeability should be made by the
FDA and based solely on scientific and medical considerations.
d. Many of the patients we treat with biologics have relatively rare conditions. In these instances
where well-designed clinical trials are not available to provide evidence of clinical efficacy and
safety, separate billing codes for biosimilars would facilitate claims-based research
encompassing differences in clinical efficacy and safety between biologics, including
biosimilars. By treating biosimilars as identical, the CMS proposal would preclude the
ability of clinicians to utilize claims data to address important questions about the
clinical efficacy and safety of different biologic products in myriad clinical settings.
PQRS/Measures Set
We understand the agency is proposing requirements for the 2018 PQRS payment adjustment that
are consistent with the requirements for the 2017 PQRS payment adjustment; if finalized, CMS
would require the same criteria for satisfactory reporting, or participation in QCDR that was
established for the 2017 PQRS payment adjustment—generally and EP or group practice reporting
nine measures covering three National Quality Strategy domains. If an individual EP or group
practice does not satisfactorily report or satisfactorily participate while submitting data on PQRS
quality measures, in 2018 that EP or group will have a 2% negative payment adjustment applied in
2018 to covered professional services furnished by an individual EP or group practice during 2018.
We understand that CMS proposes to add a reporting option, authorized under MACRA, which will
allow group practices to report quality measures data using a Qualified Clinical Data Registry
(“QCDR”). This option was previously only available to individual EPs. The ACR strongly supports
allowing group practices to use QCDRs for PQRS reporting.
Physician Compare and Physician Compare Benchmark
The ACR supports greater transparency of quality metrics; however, we have significant
concerns with the plans for including value-based modifier data both on the Physician
Compare website and in the downloadable data sets. There are major concerns that the VBM
does not accurately portray quality and cost, and physicians continue to have concerns about the
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VBM, including inaccurate risk adjustment and attribution methodologies, a rushed timeline, and
confusing feedback reports.
We respectfully urge CMS to exclude the reporting of VBM data on the Physician Compare
website and in the downloadable data set. We also request that utilization data be excluded from
Physician Compare since it is highly inaccurate. The ACR also believes the benchmark calculation is
complicated and will be difficult for consumers to understand its significance.
Electronic Health Records / Meaningful Use
CMS is proposing that EP’s report eCQM’s through their EHR. CMS is proposing to revise the
definition of certified EHR technology to require certification in accordance with criteria proposed
by the Office of the National Coordinator for Health Information Technology in relation to CMS’s
form and manner requirements for electronic submission of CQMs certified electronic health record
technology.
We strongly believe the timeline for requiring CQM reporting through EHR is aggressive and
does not allow enough time for adequate testing. Additionally, these requirements should fall on
the vendor first and foremost, not the provider, and the vendor should have to prove they are
capable of meeting this requirement to maintain their certification. Also, this requirement is
complicated and should be vetted through rigorous testing (at least one year of testing) prior to
being implemented. Testing should take place on the vendor side, with the vendors testing this
functionality and evidence being reviewed by CMS prior to this reporting becomes a requirement.
This testing should come at no additional cost to the provider. We also strongly recommend that
because the programs are consolidating, the agency needs to identify ways to collapse PQRS
and MU CQM requirements.
Value-Based Modifier
The ACR supports either significant modification or elimination of the value-based modifier. The
ACR does not believe the value-based modifier accurately portrays quality and cost for
rheumatologists. We have significant concerns about the cost component of the composite
score. Due to CMS’s decision to include Part B drugs in the cost measure and exclude Part D
drugs, the cost measure is not accurate for rheumatologists and for many other specialties
who prescribe biologic therapy.
In order for the VBM to meet its intended goal, it is imperative that the metrics accurately measure
both the quality and cost components. Under current VBM policy, payments to groups that
administer biologics under Part B may be arbitrarily reduced, and there is no adjustment taking
into account costs incurred by prescriptions from providers who prescribe biologic therapies
primarily through Part D. This flaw in the VBM inappropriately penalizes physicians based on the
way they prescribe medications, which causes concern for potential skewing of practice costs and
impacts on treatment decisions.
The current VBM policy may force providers to choose between prescribing Part B drugs and
increasing their cost measure – potentially resulting in a VBM penalty – or prescribing medication
under Part D which their patients cannot afford, causing patients to go without crucial treatment.
CMS policy should not place providers and their patients in this dilemma. Due to the way Medicare
covers biologics, patients often pay considerably more for Part D medications than Part B, and
The Honorable Andrew Slavitt
Proposed Rule; CMS-1631-P
September 8, 2015
Page 12
many patients who need access to biologics cannot afford access to Part D medications. Both
physicians and patients will be negatively impacted by this policy. Therefore, CMS should modify
the VBM cost attribution to ensure the cost calculation does not unfairly disadvantage
providers and their patients.
Stark Law / Self-Referral Updates
We appreciate CMS’ request for comments about reconciling policy that encourages coordinated
care efforts with prohibited activity outlined in the Stark law. The ACR recommends that,
because all APMs have risk and gainsharing, and represent arrangements similar to
managed care, there should be many exceptions to the Stark Law developed in relation to
APMs. Studies by HHS and think tanks could determine proposed exceptions. As an example, if a
provider is in an ACO and is incentivized by the ACO to reduce costs, and they own an MRI, there
should be exceptions that allow for use of that MRI by the provider and ACO. In general some
services that could be provided by a physician, but haven’t because of Stark prohibitions against
physician-owned ancillary services, should be revisited for APMs.
Incident-to Changes / Billing Physician as the Supervising Physician and Ancillary Personnel
Requirements
The proposed rule attempts to clarify which physician or practitioner may bill Medicare for
“incident to” services. The ACR understands the proposed rule to state that the physician or
practitioner billing “incident to” services must always be the supervising physician or practitioner.
We do not understand the rule to establish, and caution against, a mandate that the ordering
physician or practitioner must be the same as the supervising physician or practitioner. Instead,
simply that, if they are not the same physician, the Medicare billing number used should reflect the
physician or practitioner carried out the corresponding service or supervision of services.
We believe it would often be impracticable for the same ordering physician in a practice to be
available to supervise every one of their patients’ treatments. As such, any requirement that the
ordering physician also be the supervising physician would present a barrier in patient
access to care. We urge CMS to not construe the rule to mean that an ordering physician or
practitioner must always be the same as a supervising physician or practitioner in order to receive
payment for services provided.
The American College of Rheumatology appreciates the work that CMS does and the opportunity to
provide comments on the proposed rule. We look forward to assisting you with further information
and working with the agency to address concerns. If you have any questions, please contact Adam
Cooper, Senior Director of Government Affairs, at (404) 633-3777 or acooper@rheumatology.org.
Sincerely,
E. William St.Clair, MD
President, American College of Rheumatology