Eric Rugo
Vice President Government Affairs & Health Policy
6 Pearl Court
Allendale, New Jersey 07401
t: 201-749-8605 f: 201-962-4605
eric.rugo@stryker.com

June 12, 2017

VIA ELECTRONIC SUBMISSION
Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Attention: CMS-1677-P
7500 Security Boulevard
Baltimore, MD 21244-1850
RE: CMS Proposed FY 2018 Medicare IPPS Rule (CMS-1677-P)
Dear Ms. Verma:
Thank you for this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS)
proposed fiscal year (FY) 2018 Medicare hospital inpatient prospective payment system (IPPS) rule
(Proposed Rule).
Stryker is one of the world’s leading medical technology companies and together with our customers, we
are driven to make healthcare better. Stryker is committed to bringing the best possible solutions to
patients, providers, and Medicare. This philosophy has placed Stryker at the forefront of medicine’s most
promising breakthroughs in joint replacements, trauma, spine, orthobiologics, surgical navigation
systems, neurovascular solutions, robotics, and related procedures.
Our comments on the proposed FY 2018 IPPS rule focus on the following areas, as discussed in greater
detail below:


Stryker strongly supports CMS’s proposal to ensure appropriate MS-DRG classification for total
ankle replacement (TAR) procedures, as we have requested in the past. We also recommend that
CMS continue to review the cost data for revision TAR procedures in light of new, more specific
ICD-10 codes.



Stryker agrees with CMS’s proposed Medicare Severity-Diagnosis Related Group (MS-DRG)
reassignment for patients with a diagnosis of precerebral occlusion who receive a thrombolytic
agent. We encourage CMS to more broadly assess how costs are captured for patients with stroke.
In particular, CMS should similarly assess the MS-DRG assignment for cases involving mechanical
thrombectomy, especially stent retriever procedures, with payment adjusted as appropriate.



Stryker supports CMS’s efforts to improve clinical accuracy and allow appropriate assignment of
specific spinal fusion procedures.



Stryker recommends that CMS work closely with the relevant medical societies to incorporate
appropriate sociodemographic factors into quality measures/value programs as soon as feasible.

 Similarly, we urge CMS to continue to refine measures to account for the most complex cases to
promote access to care and to ensure hospitals and physicians are not unfairly penalized if they are
dealing with complex cases in a patient population that may have many comorbidities and lack
appropriate resources to comply with follow-up instructions.


In response to CMS’s request for information on CMS flexibilities and efficiencies, Stryker offers
suggestions regarding incorporating medical technology companies in health care redesign
initiatives, streamlining provider documentation requirements, and ensuring that CMS policies do
not stand in the way of personalized medicine and more efficient delivery of care.

Our detailed comments follow.

I.

MS-DRG Assignment for Total Ankle Replacement Procedures

Under current CMS policy, TAR procedures are currently assigned to both MS-DRG 469 and MS-DRG
470 (Major Joint Replacement or Reattachment of Lower Extremity with and without MCC,
respectively). Stryker has been concerned that this policy of assigning TAR cases to MS-DRG 470
results in TAR procedures being grouped with significantly less costly procedures.
We therefore support CMS’s proposal to assign all TAR procedure cases to MS-DRG 469 (currently
titled Major Joint Replacement or Reattachment of Lower Extremity with MCC) – even when there is no
MCC reported. The data presented by CMS in the Proposed Rule underscores the appropriateness and
necessity of this proposal.

Total Ankle Replacements Procedures
MS-DRG
Number of
Average
Cases
Length of Stay
MS-DRG 469– All cases
25,778
6.7
MS-DRG 469– Cases reporting TAR
procedure codes
31
4.6
MS-DRG 470– All cases
461,553
2.7
MS-DRG 470– Cases reporting TAR
procedure codes
2,114
1.9

Average
Costs
$22,139
$23,828
$14,751
$20,862

According to CMS data, the 2,114 TAR cases in MS-DRG 470 had average costs that were $6,111 higher
than the average costs of all cases in MS-DRG 470 ($20,862 compared to $14,751 for all cases).
Assignment of these cases to MS-DRG 469 would result in a more appropriate resource match from a
cost perspective, with an average cost difference of less than $1,300 instead of the current difference that
exceeds $6,100. Given the complexity of the procedure and associated resources, it is also more
appropriate from a clinical perspective to move TAR procedures to MS-DRG 469, and we were pleased
that the CMS clinical advisors pointed this out.
We therefore endorse CMS’s proposal to move all TAR procedure cases to MS-DRG 469 and to retitle
MS-DRG 469 as “Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with

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 MCC or Total Ankle Replacement.” We believe this proposal would compensate hospitals appropriately
for TAR procedures, and in turn enable hospitals to furnish this important procedure to Medicare
beneficiaries.
CMS also discusses a request to modify the MS-DRG assignment for revision of TAR procedures, which
currently are assigned to MS-DRGs 515, 516, and 517 (Other Musculoskeletal System and Connective
Tissue O.R. Procedures with MCC, with CC, and without CC/MCC, respectively). This request was
prompted by the availability of recently-established ICD-10-PCS codes that are specific to revision of
TAR procedures.
The Proposed Rules states that the December 2016 update of the FY 2016 MedPAR file included only six
cases of revision of TAR procedures within MS-DRGs 515-517. CMS contends that this volume does not
justify establishing a new MS-DRG for these cases. We agree that it is premature to take action based on
this limited data; instead, we request that CMS revisit this data in next year’s rule and incorporate it as
appropriate when considering MS-DRG assignment for these procedures.

II.

Transient Ischemic Attack – Stroke Treatment and DRG Assignment

CMS has proposed improvements to the MS-DRG classification of patients with a diagnosis of
precerebral occlusion who receive a thrombolytic agent (i.e., tPA) to prevent a stroke. Specifically, CMS
proposes adding additional ICD-10 codes to MS-DRGs 061-063 (Acute Ischemic Stroke with Use of
Thrombolytic Agent with MCC, with CC, and without CC/MCC, respectively) when reported with a
thrombolytic agent (i.e., tPA), and revising the MS-DRG titles accordingly. These ICD-10 diagnosis
codes currently assigned to MS-DRGs 067 and 068 (Nonspecific CVA and Precerebral Occlusion without
Infarction with MCC and without MCC, respectively), and MS-DRG 069 (Transient Ischemia Attack or
TIA).
We agree with CMS’s assessment that costs are significantly higher for cases with tPA versus cases
without tPA in these MS-DRGs and that there would be clinical benefits to such reassignment.
Nevertheless, we believe that CMS should more broadly assess how costs are captured for patients with
stroke. In particular, CMS should similarly assess the MS-DRG assignment for cases involving
mechanical thrombectomy, especially stent retriever procedures, with payment adjusted as appropriate.

III.

MS-DRG GROUPER Logic: Spinal Fusion Procedures

CMS is proposing modifications of the GROUPER logic with regard to the following spinal fusion MSDRGs: 453-455, Combined Anterior/Posterior Spinal Fusion W MCC, W CC, and W/O CC/MCC,
respectively. In particular, CMS proposes to correct the GROUPER logic for seven new ICD-10-PCS
procedure codes established in October 2016. These codes describe fusion using a nanotextured surface
interbody fusion device. These codes were not added to the appropriate GROUPER logic list.
Stryker supports CMS’s efforts to improve clinical accuracy and allow appropriate assignment when both
an anterior and posterior spinal fusion is performed.

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 IV.

Social Risk Factors in IPPS Quality Measures

CMS invites comments on the potential addition of future measures to account for social risk factors
within the Hospital Inpatient Quality Reporting Program, the Hospital-Acquired Condition Reduction
Program, and the Hospital Value-Based Purchasing Program.
Stryker has long supported the recognition of appropriate socioeconomic risk factors under Medicare
quality and value programs. Adjustment for economic and demographic factors is critical to ensure that
hospitals are not penalized based on the populations they serve and/or factors beyond their control. As of
Medicare payments to hospitals are increasingly tied to quality performance, it is imperative that those
quality measures capture the full range of factors that could influence hospital performance. We therefore
recommend that CMS work closely with the relevant medical societies with a goal of incorporating
appropriate socioeconomic/sociodemographic factors into quality and value measures as soon as feasible
and on a permanent basis.
Similarly, we urge CMS to continue to refine measures to account for the most complex cases to promote
access to care and to ensure hospitals are not unfairly penalized.

V.

“Request for Information” on CMS Flexibilities and Efficiencies

In the Proposed Rule, CMS asks the public for suggestions on ways to reduce burdens for providers and
patients, improve quality of care, decrease costs, and make other health system improvements. We
commend CMS for both these broad goals and for soliciting stakeholder recommendations for specific
pathways for achieving these goals.
One of the areas on which CMS requests comments is payment system redesign. As Medicare and other
payers move away from fee-for-service and towards value-based medicine, there is a growing
appreciation of the role that non-providers can plan in facilitating the efficient delivery of high-quality
medical services to patients. For instance, a Bundled Payment for Care Initiative (BPCI) evaluation
report1 notes that external industry partners that provide data analytics, management, and other support
activities for BPCI participants play significant roles in managing data systems, performing internal data
analyses, and conducting patient tracking and improving care. These partnerships also “facilitate
coordination among independent entities …” and “enable them to focus on population health and tracking
patient outcomes.” We are proud that Stryker Performance Solutions serves as a BPCI Awardee
Convener, and continues to provide support teams and data analytic solutions to promote successful
bundled payment participation, including improved quality outcomes, patient satisfaction, and efficient
use of resources.
Unfortunately, in other innovative Medicare delivery models, such as the Comprehensive Care for Joint
Replacement (CJR) model and Episode Payment Model (EPM) initiatives, CMS has barred manufacturers
and many other non-providers from initiating payment episodes or assuming risk. We encourage CMS to
reexamine these policies and incorporate expanded roles for non-providers in future CJR and EPM
1

See Lewin Group “BPCI Models 2-4: Year 2 Evaluation & Monitoring Annual Report,” Prepared for CMS,
August 2016, available at https://innovation.cms.gov/Files/reports/bpci-models2-4-yr2evalrpt.pdf, page 90.

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 program years. Going forward, we urge CMS ensure that all care innovation partners – including medical
technology companies – are welcome as full participants in health care redesign initiatives.
CMS also requested comments regarding elimination or streamlining of documentation requirements.
Stryker is aware that documentation requirements to prove compliance with local coverage
determinations have been burdensome for physicians, particularly with regard to knee and hip
replacement surgery. We encourage CMS to look for ways to impose the least burdensome
documentation requirements while safeguarding patient care and program integrity. We also encourage
CMS to promote greater simplicity in its quality/value programs, given that it is increasingly too
cumbersome and confusing for providers meet to all program requirements. We urge CMS to align and
streamline policies wherever possible.
With regard to facilitating individual preferences, we urge CMS to take action to ensure that outdated
coverage/payment policies do not stand in the way of personalized medicine and more efficient delivery
of care. For instance, device manufacturers are developing tools and techniques that can enable surgical
instrumentation that is tailored to the patient’s particular surgery, but Medicare patients are often denied
access to this proven care because these innovations do not fit neatly into standard benefit categories. As
the pace of medical innovation accelerates, CMS policies and decision-making will need to be more
nimble – or Medicare beneficiaries will not be able to reap the full benefits of personalized medicine.
CMS requests comments on when and how it issues regulations and policies. We urge CMS to refrain
from releasing regulations the day before a federal holiday or on or immediately before a religious
holiday. The common practice of releasing rules on the eve of 4th of July or other holidays complicates
assessment and needlessly burdens the public as they need to review and respond to such rules.
CMS also invites comments on proposals that “involve novel legal questions.” Stryker requests that CMS
consider amendments establishing new safe harbors to the federal anti-kickback statute for value-based
arrangements, specifically addressing pricing adjustments and bundled services provided with the medical
product to facilitate clinical and/or cost objectives, along with protection for manufacturers who make
clinical/cost outcome assurances. Stryker is at the forefront of developing novel technologies that prevent
never events, improve treatment for stroke and various orthopaedic conditions, among other things. For
these reasons, Stryker recommends that CMS consider specifically approving a safe harbor for financial
arrangements that include a discount on a variety of bundled items (e.g., implants, consulting services,
medical imaging). Stryker also recommends that CMS consider specifically approving a safe harbor for
value-based warranties that would allow manufacturers of products to make certain clinical and/or
outcomes assurances, and provide an appropriate remedy where such outcomes are not achieved.
These additional safe harbors or amendments, with appropriate safeguards, would mitigate current
barriers to the types of multi-party collaborative efforts that can drive health system reform.
*****

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 Thank you for your consideration of our comments, which are intended to promote Medicare beneficiary
access to important medical treatment options in the inpatient setting. If you have any questions, please
do not hesitate to contact me.

Sincerely,

Eric Rugo
Vice President Government Affairs and Health Policy

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