August 28, 2015 Mr. Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1633-P P.O. Box 8013 Baltimore, MD 21244-8013 File Code: CMS–1633–P Re: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals under the Hospital Inpatient Prospective Payment System Dear Mr. Slavitt: On behalf of its member hospitals, the Michigan Health & Hospital Association (MHA) appreciates this opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed rule to update the hospital Outpatient Prospective Payment System (OPPS) for 2016. We are very disappointed that this proposed rule includes a negative rate update. Overall, as proposed, when all changes are considered, this rule is projected to increase Medicare fee-for-service (FFS) OPPS payments to Michigan hospitals by approximately $3.8 million, or 0.2 percent in 2016. We do not believe this is an adequate increase for hospitals since it fails to cover medical inflation. In addition, this excludes the estimated $38 million negative impact of the continued sequestration. As a result, the financial viability of Michigan hospitals and their ability to provide care to residents in their communities will be further threatened. The adequacy of Medicare payments to cover the cost of services provided is vital for ensuring the future viability of Michigan’s hospitals. Medicare outpatient services represent a significant percentage of Michigan hospital revenue and generated a negative outpatient margin of 12 percent in 2013 based on Medicare allowable cost. Trended forward with cost increases that have exceeded the Medicare market basket updates, these margins have declined in recent years and are expected to decline further in subsequent years. Michigan’s population continues to age with approximately 19 percent covered by Medicare, with the number of Medicare beneficiaries projected to increase by 48 percent over the next decade. For Michigan, outpatient services comprise a median volume of 67 percent, with even the largest inpatient facilities having outpatient volumes above 45 percent. The MHA’s key concerns regarding the 2016 OPPS proposed rule will focus on the CMS proposals related to the: Two-midnight policy including changes to the Recovery Audit Contractor (RAC) program and the 0.2 percent inpatient payment reduction implemented in FY 2014 Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 2 of 12 The two percent reduction in OPPS conversion factor due to incorporation of lab test reimbursement into APCs Restructuring of Ambulatory Payment Classifications (APCs) Changes to Comprehensive APCs (C-APCs) Payment Changes for Computed Tomography (CT) Proposed data collection for non-primary services in C-APCs High-cost Laboratory Services Proposed adjustment to OPPS payments for Discontinued Device-intensive Procedures Lung Cancer Screening with Low-Dose CT Advanced Care Planning Payment for Blood and Blood Products Outpatient Quality Reporting Program Changes Two-Midnight Policy The MHA appreciates the opportunity to provide additional input to the CMS regarding the twomidnight policy. We appreciate the CMS’ consideration of feedback received from stakeholders and believe that the proposed revisions are a step in the right direction. We believe that the CMS’ proposal recognizes the importance of physician judgement and individual patient needs in the hospital admission decision-making process. We also appreciate the recent announcement that the partial enforcement delay of the two-midnight policy has been extended through Dec. 31, 2015. However, the MHA urges the CMS to extend the enforcement delay until March 31, 2016. This would allow time for hospitals to implement the policy changes while also ensuring that the CMS has adequate time to issue detailed guidance which will be crucial to implementation of the new policies and revised admission criteria by hospitals and the CMS review contractors. In the proposed rule, the CMS indicates that it continues to believe that the use of the twomidnight threshold is appropriate. However, the CMS also acknowledges that certain procedures may have intrinsic risks, recovery impacts or complexities that would cause them to be appropriate for inpatient coverage under Medicare Part A, regardless of the length of hospital time the admitting physician expects a particular patient to require. As a result, the CMS proposes that certain hospital inpatient services that do not cross two midnights may be appropriate for payment under Medicare Part A if a physician determines and documents in the patient’s medical record that the patient requires reasonable and necessary admission to the hospital as an inpatient. The CMS indicates that the following factors, among others, would be relevant in determining whether an inpatient admission where the patient stay is expected to be less than two midnights is appropriate for Part A payment: The severity of the patient’s signs and symptoms; The medical predictability of something adverse happening to the patient; and The need for diagnostic studies that appropriately are outpatient services. Based on the proposed rule, an inpatient admission would be payable under Part A if the documentation in the medical record supports either the admitting physicians’: Reasonable expectation the patient requires an inpatient stay that will span at least twomidnights, or Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 3 of 12 Determination, based on the factors identified above that the patient requires formal admission to the hospital on an inpatient basis. The CMS also proposes that Quality Improvement Organizations (QIOs) rather than RACs and Medicare Administrative Contractors (MACs) will conduct initial medical reviews of patient status claims and provide hospitals with additional education regarding the CMS’ two-midnight policy. Under the QIO short-stay inpatient review process, hospitals that are found to exhibit a pattern of practices, including, but not limited to: having high denial rates and consistently failing to adhere to the two-midnight rule (including having frequent inpatient hospital admissions for stays that do not span one midnight), or failing to improve their performance after QIO educational intervention, will be referred to the recovery auditors for further payment audit. We appreciate that the proposed rule maintains that patients stays of two midnights or longer are appropriate for payment as inpatient cases. However, the MHA believes that the CMS must provide hospitals with the tools and time necessary to effectively implement any modifications to the twomidnight policy that may be finalized. As such, the MHA requests that the CMS provide clear, detailed and precise guidance for hospitals, physicians and Medicare review contractors after any changes are finalized. We urge the CMS to do this as soon as possible so that providers have time to re-evaluate and potentially alter internal policies, educate physicians and other staff on these changes, alter workflow processes and update existing electronic medical records systems to ensure compliance with the revised policy. The MHA is supportive of the CMS’s proposal to shift first line medical review responsibilities for patient status claims to QIOs from the RAC since the QIOs are not paid on a contingency basis and therefore have no incentive to be overzealous with their audits. However, we urge the CMS to delay the QIO audits until March 31, 2016, to align with our requested extension of the partial enforcement delay, but at minimum until the Jan. 1, 2016, effective date of this policy. Overall, we are pleased that the CMS will be using QIOs. However, since many details of the proposal are lacking, the MHA requests that the CMS provide additional information as soon as possible to assist hospitals in preparing for these audits. While we believe leveraging the QIOs’ expertise to provide a first level of review begins to address the misaligned economic incentives inherent when a contractor’s compensation is tied to the volume of claims denied, the CMS needs to provide additional clarity around the circumstances under which a hospital would be referred to the RAC. While the proposed rule articulates a loose “pattern of practices” that trigger referral to the RAC, it is neither exhaustive nor are the examples specific enough for hospitals to understand the bar against which they will be measured. The MHA requests that the CMS work with the hospital community to define a concrete framework that will govern when a hospital is referred to the RAC. Specifically, the framework needs to address the following: 1) Provide an exhaustive list of factors that the CMS will consider as it attempts to establish a “pattern of practices” that suggests habitual non-adherence to the two-midnight rule (including the “rare and unusual exceptions policy). Further, the MHA believes that denial rates should be considered relative to a facility’s percentage of short stays and percentage of inpatient versus outpatient visits. 2) The CMS needs to calculate the “denial rate” used to identify facilities with a “high denial rate” after all appealed cases have been resolved. Alternatively, if the CMS wants to calculate a more Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 4 of 12 timely denial rate (given the existing appeals backlog) it should exclude cases that are currently being appealed from the numerator and denominator of the denial rate calculation. We believe it is inappropriate to penalize a hospital for a contractor’s lack of understanding of what constitutes an appropriate inpatient admission. 3) The CMS needs to define what it considers to be a “high-denial” rate. The MHA believes the benchmark used for the denial rate should focus on facilities that are clearly outliers. 4) How will the CMS handle hospitals that lack a sufficient sample size of QIO reviewed cases to arrive at an accurate understanding of hospital performance? The MHA believes that the CMS should exclude these hospitals from referral to the RAC. 5) The MHA believes that the CMS needs to limit the criteria for referral to the RAC to “having a high denial rate”. As currently written, the criteria “consistently failing to adhere to the twomidnight rule (including having frequent inpatient hospital admissions for stays that do not span one midnight)” does not clearly reflect the CMS’ “rare and unusual exceptions policy” in the 2016 OPPS rule. It is possible that a hospital could “consistently fail to adhere to the twomidnight rule,” but the cases in question have sufficient, documented medical necessity to support an inpatient admission. It would be inappropriate to refer a hospital that is adhering to the CMS’ two-midnight billing policies to the RAC due to its mix of inpatient cases. Regarding “failing to improve,” the MHA is concerned that criteria could be used to refer a hospital to the RAC in an instance where the hospital has a low denial rate that remains unchanged between QIO reviews. 6) The CMS needs to define the timeframe/number of QIO audits that it will use to determine whether a hospital should be referred to the RAC. The MHA believes the decision to refer a hospital to the RAC should be based on more than one audit sample. Basing the decision off of one audit increases the chance that a hospital’s performance is not representative due to an adverse selection of claims in a relatively small sample. A “one strike” policy also does not afford the hospital an opportunity to incorporate the education it receives from the QIO into its processes before it is penalized. 7) The CMS needs to define the sample size that will be reviewed by the QIO. The MHA urges the CMS to balance the need for a statistically representative sample size with the need to minimize the administrative burden on hospitals. 8) The CMS needs to define the duration for which a referred hospital’s patient status reviews will be referred to the RAC. The MHA believes that a referral decision should be re-evaluated based on the error rate determined by the QIO. RACs have a misaligned economic interest in retaining the hospital audit. Also, as stated above, the error rate used should either consider the outcome of appeals, or exclude appealed cases from the numerator and denominator of the error rate calculation. 9) The CMS needs to define the number of claims a RAC will be allowed to review if a hospital is referred to the RAC. The MHA urges the CMS to balance the number of claims to be reviewed while minimizing the administrative burden on hospitals. Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 5 of 12 10) It is our understanding that unlike the RACs, the QIOs do not have the ability to accept electronic medical records for review. The MHA urges the CMS to ensure that QIOs not only have clear guidance regarding how to perform these audits but also the resources necessary to complete these audits in a fair, impartial and efficient manner, including the capability to accept electronic medical records for audit review. Changes to the RAC Program In the proposed rule, the CMS describes the changes to the RAC program announced on Dec. 30, 2014, and that it intends to make effective when awarding new RAC contracts. These include: revised limits to additional documentation requests that are based on a hospital’s compliance with Medicare rules. In addition, in an effort to address hospital concerns that they do not have the opportunity to rebill for medically necessary Part B services by the time the RAC has denied a Part A claim, the CMS will modify the lookback period for patient status reviews to six months from the date of service (rather than the current period of three years) in cases where a hospital submits a claim within three months of the date of service. It is unclear when the CMS will award the new RAC contracts. Therefore, the MHA, along with the AHA and others, urge the CMS to adopt and makes these changes fully effective as soon as possible, rather than waiting until the new RAC contracts are awarded. In addition, we urge the CMS to provide clear and transparent communications to the provider community regarding the progress of these changes as they are incorporated into the RAC program. We also encourage the CMS to consider and support the following changes that would address the systemic problems with the RAC program: Prohibit any RAC payment structure that encourages RACs to deny claims. Impose a financial penalty on RACs that consistently show a high rate of denials that are overturned on appeals. Codify the requirement that RACs consider only the medical documentation available at the time the admission decision was made in determining whether an inpatient stay was medically necessary. Eliminate application of the one-year filing limit to rebilled Part B claims. Limit RAC auditing of approved issues to a defined time period, instead of approving them indefinitely, as is the current practice. 0.2 Percent Inpatient Payment Reduction Additionally, in the discussion of economic impacts, the CMS updates its justification for the 0.2 percent reduction to IPPS rates related to the implementation of the two-midnight policy. The CMS provided additional details in the 2016 proposed OPPS rule regarding the 0.2 percent reduction in IPPS payments that took effect in fiscal year (FY) 2014 when the two-midnight rule was implemented. The reduction was a result of the CMS’ projection that the two-midnight rule would increase inpatient volume by a net 40,000 cases. Although the CMS offers anecdotal evidence in the proposed rule that could support its projections, analysis presented by the American Hospital Association (AHA) in its 2016 IPPS Proposed Rule comment letter provides evidence of decreased inpatient utilization as a result of Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 6 of 12 the two-midnight rule. As a result, the MHA requests that the CMS reverse the permanent, unjustified payment cut as it is unlawful and unwarranted. Two Percent Reduction in OPPS Conversion Factor Due to Packaging Lab Payments into APCs The CMS proposes to apply a two percentage point reduction to the OPPS conversion factor to correct for the Office of the Actuary’s incorrect estimation of lab payments that should have been packaged into APC payments for lab tests (instead of being paid under the Clinical Laboratory Fee Schedule). The packaging policy was effective for 2014. Based on the CMS’s calculation, hospitals were allegedly overpaid $1 billion. The purpose of the two percentage reduction is to recoup that amount. As proposed, this adjustment would reduce OPPS payments to Michigan hospitals by $38 million in 2016. The proposed rule fails to provide sufficient detail to account for all of the changes that occurred to OPPS payments during 2014 and accurately reproduce the CMS’ calculation. The CMS needs to provide the detailed assumptions related to the packaging of lab payments and other parameters used to arrive at its alleged overpayment so that the hospital community can reproduce its calculation. Until that time, the MHA objects to the proposed two percentage point reduction and urges that the CMS not finalize it. It is inappropriate to penalize hospitals for a miscalculation by the CMS actuaries that is beyond their control. In addition, basing a cut on 2014 claims data is inappropriate as the CMS’ 2014 instructions to hospitals regarding how to bill for lab tests were confusing and modified several times. Therefore, any “unexpectedly high” volume of separately payable laboratory tests that the CMS observed in 2014 claims data does not reflect a permanent change to hospital coding and billing practices, but instead is a result of unclear and frequently changing billing instructions. Ambulatory Payment Classification (APC) Restructuring The CMS proposes to restructure the APC groupings for nine APC clinical families by using the same principles used in restructuring the ophthalmology and gynecology clinical families in 2015. As part of this restructuring, the CMS also proposes to renumber several families of APCs to provide consecutive numbering of consecutive APC levels within the clinical family. The proposed restructuring results in significant movement in HCPCS codes between APCs, consolidation of APCs and substantial payment changes. However, the CMS has provided limited details regarding why and how it is proposing to restructure the nine individual clinical families. The MHA requests that the final rule include a separate impact analysis for each restructured APC clinical family showing the distributional impact of the restructuring across the usual categories including rural/urban, bed size, teaching/non-teaching, and type of ownership. The MHA also urges the CMS to provide additional rationale and a separate impact analysis for any significant shift in policy, such as the proposed APC restructuring. The MHA is also concerned about the proposed restructuring of the nuclear medicine and positron emission tomography (PET) APCs. For 2016, the CMS proposes to collapse the 17 different nuclear medicine and PET APCs into three levels. The MHA believes that the CMS’ proposal inappropriately overlooks the clinical distinction between these modalities. Instead, the MHA recommends that the CMS: Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 7 of 12 Maintain a distinct APC for all PET procedures Maintain a distinct APC for therapeutic nuclear medicine procedures Maintain individual APCs for diagnostic nuclear medicine tests; and Continue to use the individual cost centers and revenue codes for rate setting of APCs for each imaging modality. Changes to Comprehensive APCs (C-APCs) The CMS proposes to pay for all qualifying extended assessment and management encounters through a proposed new comprehensive APC (C-APC) 8011 (Comprehensive Observation Services) and to assign the services within this C-APC a new proposed status indicator (SI) of “J2”. Among the proposed criteria for a claim to qualify for C-APC 8011 is that the claim does not contain a HCPCS code which has been assigned a SI “T” (procedure/service to which the multiple procedure reduction applies) that is reported with a date of service on the same day or one day earlier than the date of service associated with HCPCS code G0378 (Observation services per hour). However, SI “T” procedures that are reported with a date of service after G0378 would have their cost packaged as part of C-APC 8011, meaning that no separate payment would be made for such procedures. An analysis by the AHA found that SI “T “procedures are often not provided after the date of service of G0378 but when they are, these procedures are associated with a high payment rate. Specifically, these procedures occurred in less than 5 percent of J2 claims. However, individually, many of these procedures are high-cost procedures with payments rate over $2,000. As a result, the MHA recommends that the CMS exclude from the definition of C-APC 8011 all claims that includes SI T procedures with a date of service after G0378 since we believe these procedures are too costly to package into the C-APC 8011. This would help preserve access in hospitals that perform a high volume of these diagnostic cardiac catheterization services and other procedures with a SI “T”. Changes for Payment for Computed Tomography (CT) Effective for services provided on or after Jan. 1, 2016, the CMS proposes to implement a nonbudget neutral provision of the Protecting Access to Medicare Act of 2014 (PAMA) that would reduce CT payment by 5 percent in 2016 and 15 percent in 2017 and subsequent years, for certain CT services provided using equipment that fail to meet each attribute of the National Electrical Manufacturers Association (NEMA) Standard XR–29–2013. The provision requires that information be provided and attested to by a supplier and a hospital outpatient department that indicates whether an applicable CT service was furnished that was inconsistent with the NEMA CT equipment standard. To implement this provision, the CMS proposes to establish a new modifier that would be reported with specific CPT codes, effective Jan. 1, 2016. The use of this modifier would result in the applicable payment reduction for the CT services, as required by the PAMA. While the MHA supports the intent of this proposal, we have several concerns regarding the CMS’ proposal. As of August, 2015 the CMS has not presented a request to the National Uniform Billing Committee (NUBC) to add a modifier related to compliance (or non-compliance) with the XR– 29–2013. The CMS needs to take this step immediately. The MHA recommends that the CMS develop the modifier to indicate a study that was performed on equipment that fails to meet Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 8 of 12 the XR–29–2013 standard. Any claim billed without the modifier would then imply that the machine on which the study was performed meets the XR–29–2013 standard. While applying this modifier in a freestanding setting with only one CT scanner is relatively straight forward, it is extremely complicated in a health system setting. It is not uncommon for large health systems to have dozens of CT machines that are billed from a central billing office. Some of these machines will comply with XR–29–2013 by Jan. 1, 2016, while others will not. Data from an HFMA survey of 230 members of the Medical Imaging and Technology Alliance (MITA) finds that currently 42 percent of respondents are XR–29–2013 compliant. Only 68 percent of respondents anticipate they will be fully compliant by Jan. 1, 2016. At this time health systems do not have a process in place to trace a CT scan back to the machine on which it was performed. This is key to complying with the requirement. Establishing a process to accurately trace a CT study back to the source equipment on which it will be performed and then hardwiring this information into the billing and coding system will be a time consuming process. Additionally, hospitals will need the modifier before they can complete this process. In light of these concerns, the MHA urges that the CMS delay enforcement of this requirement until the end of the third full quarter after the NUBC issues a modifier to indicate non-compliance with XR–29–2013 standard. If the modifier is enforced on Jan. 1, 2016 as proposed, many health systems with even one non-compliant CT scanner will be forced to hold CT claims for related CPT codes. Given this requirement was promulgated in the April 1, 2014 PAMA, we believe that the CMS has had sufficient time to work with stakeholders to implement the requirement in a manner that is the least burdensome. It is inappropriate that the CMS would disrupt hospital cash flow for these services. Proposed Data Collection for Non-Primary Services in C-APCs In an effort to identify future items and services that should be incorporated into payment for comprehensive APCs, the CMS proposes to establish a HCPCS modifier to be reported with every code that is adjunctive to a primary service (a “J1” status) and occurs prior to the J1 service. The requirement applies only to claims billed on the UB-04 as there is no parallel requirement for services provided in a freestanding setting. It appears that the CMS intends for the modifier to be applied to adjunctive services for all C-APCs. The MHA requests that the CMS clearly state its intent in the final rule. The specific reference to collecting data for Stereotactic Radiosurgery (SRS) leads hospitals to question whether the data collection proposal is limited to SRS or is applicable to all C-APCs. The MHA cautiously supports the CMS’ transition of OPPS to a system of larger bundles. However, due to the administrative burden this reporting requirement would impose on providers, we believe there are several issues, outlined below, which the CMS should resolve prior to moving forward with this proposal. 1) The CMS needs to define the timeframe that hospitals need to look back and append the modifier onto adjunctive services. We believe that the CMS needs work with stakeholders to define an appropriate window for packaging services into a comprehensive APC. Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 9 of 12 2) Almost all of the coding for services adjunctive to a J1 APC is currently automated. A recent survey by the Healthcare Financial Management Association found that hospitals estimate that this requirement impacts 30 – 50 percent of their outpatient claims. As such, the proposal would increase hospital accounts receivable and reduce operating cash flow while increasing administrative costs. As an example to provide context, based on one service-line alone, a mid-size hospital (approximately 220 acute beds) estimated the proposed rule would impact 300 cardiology cases annually. For a hospital to accurately append the modifier to adjunctive services, it requires a computer programming change to identify the potential related services, create an automated exceptions list which would hold the claims from billing, and then manually review each claim to determine if the service is truly adjunctive. It is estimated that the information technology cost alone would range $10,000 to $15,000 per hospital. There is also a significant increase in staffing cost for additional coding professionals to perform the manual review. The MHA believes that it inappropriate that hospitals are expected to bear the cost of the CMS’ refinement of the OPPS. Instead, the CMS should either propose a method to collect data that does not pose a significant administrative burden to providers or provide additional payment to offset the additional administrative costs. High Cost Laboratory Services The MHA urges the CMS to cautiously evaluate whether it is appropriate to package high-cost lab tests into lower cost APCs, such as those assigned SI “QI” and “Q2” before taking additional steps to expand lab test packaging to the claims level. Services assigned to “Q1” and “Q2” are ancillary services, some of which have relatively low costs, such as x-rays. The CMS proposes to package certain high-cost lab tests, which are ancillary services themselves, into other ancillary services. Over time, this could distort the geometric mean cost of those ancillary services, particular if the CMS expands lab packaging to the claims level. Proposed Adjustment to OPPS Payment for Discontinued Device-Intensive Procedures The CMS proposes to reduce the payment rate for discontinued device dependent procedures that either do not require anesthesia (modifier 52) or procedures that are discontinued before anesthesia is administered (modifier 73). Specifically, the APC payment amount would be reduced by 100 percent of the device offset prior to applying the additional payment adjustments that otherwise apply when the procedure is discontinued. The CMS believes that in instances where a procedure either does not require anesthesia or is discontinued before anesthesia is administered that the device remains sterile which means it can be reused. The MHA disagrees with the CMS’ assertion that in cases where modifier 52 or 73 apply the device remains sterile. In the majority of instances, all of the supplies (including devices/surgical packs) necessary for a specific procedure are removed from their sterile packaging prior to the decision to proceed with a procedure. In cases where the procedure is discontinued prior to the administration of anesthesia (or if anesthesia is not involved), the sterile supplies that would have been used for the Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 10 of 12 procedure must be discarded. Further, manufacturers do not provide instructions for re-sterilizing these materials –if that is even possible. The MHA urges the CMS not to finalize this proposal. It is inappropriate for the CMS to penalize hospitals for circumstances beyond their control, such as a change in the patient’s medical condition which prevented the procedure from being performed as initially planned. The MHA encourages the CMS to conduct a thorough and detailed analysis and work with device manufacturers to better understand whether devices can safely be used for another case. Lung Cancer Screening with Low-Dose CT The CMS notes that Medicare coverage for lung cancer screening with low-dose CT was approved in a national coverage decision (NCD) on Feb. 5. In the rule, the CMS proposes two HCPCS G-codes describing the services and identifies the APCs to which the services would be assigned. However, final HCPCS G-codes and their APC assignment will not be effective under this rule until Jan. 1, 2017. In the absence of final G-codes, hospitals that provide these services could be holding claims for up to 11 months. The maximum period for submission of all Medicare claims is no more than 12 months after the date of service. The MHA recommends that the CMS make the effective date for the new HCPCS Gcodes for lung cancer screening retroactive to the February NCD date. In addition, we recommend that the CMS extend the one-year claims filing deadline by at least one additional quarter in 2016 to allow hospitals adequate time to submit the held claims. We also recommend that the CMS ensure that the new G-codes are included in the final list of preventive services that are excluded from packaging under the C-APCs. Advanced Care Planning Codes The MHA recommends that advanced care planning codes be separately payable under the OPPS and assigned to an appropriate APC. As proposed, the CMS assigns the new CPT codes for these services to CPT 99497 and 99498 as having SI “N”, which means that these are packaged services under the OPPS, with no separate payment permitted. By contrast, the CMS proposes these services for payment under the 2016 Medicare Physician Fee Schedule. Payment for Blood and Blood Products The CMS is proposing significant payment reductions for all blood components commonly provided in the hospital outpatient setting. These cuts range from 23 to 66 percent, and would result in payments that are less than the acquisition costs for most of these products, and in some cases, less than the cost to produce the products. As a result, the MHA is concerned that the CMS made an error in determining the proposed payment rates. To ensure continued beneficiary access to all blood and blood products, the MHA urges the CMS to review its data and calculations and correct any errors. In the event that no error is found, we encourage the CMS to mitigate the reduction and negative impact to hospitals by limiting the payment cut to 25 percent. Outpatient Quality Reporting Program Changes Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 11 of 12 The CMS proposes to add two new measures to the program – one assessing whether radiation therapy is delivered in appropriate doses to patients with bone cancers, and another measuring whether the medical records of emergency department patients transferred to another health care facility include certain clinical and administrative data. The CMS also proposes the removal of one measure and several changes to the OQR program administrative requirements. Overall, the MHA encourages the CMS to focus on measures that matter and urge the CMS to streamline and refocus the OQR program measure set so that it aligns with concrete national priority areas for improvement across the entire health care system. The MHA, along with the AHA and others, urge the CMS to identify concrete, actionable national goals for quality improvement, and to use those goals to select a small number of reliable, accurate and care-setting appropriate measures to ensure that each relevant part of the health care system contributes to the overall goals. For this reason, the MHA urges the CMS to consider adopting the recommendations outlined in the Institute of Medicine’s Vital Signs report for streamlining and focusing national quality measurement efforts. If adopted, the report’s recommendations would facilitate better use of quality measures for all stakeholders to advance health care. The MHA believes OP-33 – External Beam Radiotherapy (EBRT) for Bone Metastases - may be an appropriate addition to the OQR program in the future. However, prior to adopting the measure, the MHA urges the CMS to reassess whether OP-33 addresses an issue of sufficiently broad scope and priority that merits inclusion in the OQR program, and to ensure the measure is feasible to collect in the Hospital Outpatient Department setting. The MHA, along with the AHA, opposes the proposed addition of OP-34 – ED Transfer Communication – to the QOR program at this time due to concerns that implementation of this measure would duplicate and potentially conflict with other CMS efforts aimed at improving care transitions. As a result, we urge the CMS not to finalize this measure at this time. In addition, the adoption of this measure would divert attention and resources from other activities that involve the collection and use of the data OP-34 seeks to assess while also leading to an inconsistent approach to improving care transitions across the delivery system. While we appreciate the proposed removal of OP-15, the MHA also urges the CMS to remove several other measures from the OQR program, based on recommendations from the Measure Applications Partnership (MAP). In early 2012, the MAP conducted a review of measures and suggested that seven previously-finalized measures were directionally correct but were inappropriate for use in the OQR program. Given this assessment and the MAP recommendations, the MHA urges the CMS to immediately remove six measures from the OQR program as reflected in the table below: OQR Measures Not Recommended by the MAP OP-9: Mammography Follow-up Rates OP-10: Abdomen CT – Use of Contrast Material OP-14: Simultaneous Use of Brain CT and Sinus CT OP-20: Door to Diagnostic Evaluation by a Qualified Medical Professional OP-22: ED Patient Left Without Being Seen OP-25: Safe Surgery Checklist Use Michigan Health & Hospital Association (MHA) Comments – Medicare 2016 OPPS Proposed Rule Aug. 28, 2015 Page 12 of 12 SUMMARY The MHA appreciates this opportunity to provide comments to the CMS regarding this proposed outpatient rule. We believe our suggested modifications will result in positive changes for hospitals and the Medicare beneficiaries they serve. If you have questions on this comment letter, please contact me at (517) 703-8603 or mklein@mha.org. Sincerely, Marilyn Litka-Klein Vice President, Health Finance Policy and Health Delivery