NUBC Meeting April 17-18, 2018 The Hilton Baltimore BWI Airport 1739 W. Nursery Rd. Linthicum, MD TENTATIVE AGENDA (as of 4/10/18)

Transcription

1 NUBC Meeting April 17-18, 2018 The Hilton Baltimore BWI Airport 1739 W. Nursery Rd. Linthicum, MD TENTATIVE AGENDA (as of 4/10/18) April 17, Open NUBC Meeting - Concourse C&D (Dress: Business Casual) 1:00-1:15 pm Welcome and Introductions 1:15-1:30 Review and Approval of the August 8-9, 2017 Meeting Minutes 1:30-2:45 Change Requests (County Codes): CMS - New Value Code to Identify the County of Residence of a Patient Receiving Home Health Services (see Attachment 1) Service Facility Location County Code (see Attachment 1a for Informational Purposes Only) Other Issues/Changes Cellular Therapy - CAR T Billing Methodology (see Attachment 2) 2:45-3:00 Break 3:00-4:30 Other Issues/Changes Continued Request for Review of Priority (Type) of Admission/Visit Definitions (FAQ Development) (see Attachment 3) State Issues o Rehabilitation Codes (see Attachment 4) (OVER) 1

2 NUBC Meeting April 17-18, 2018 The Hilton Baltimore BWI Airport 1739 W. Nursery Rd. Linthicum, MD TENTATIVE AGENDA (as of 4/10/18) April 18, Open NUBC Meeting - Concourse B (Dress: Business Casual) 8:00-8:30 a.m. Breakfast 8:30-9:00 State and other Issues NUBC/NUCC Joint Meeting 9:00 a.m. I. Appropriate Use Criteria Appropriate Use Criteria for Advanced Diagnostic Imaging (see Attachment JM1-JM2) 10:30 a.m. II. New Medicare Card Project 11:30 a.m. III. Medicaid Electronic Visit Verification System (see Attachment JM3) 12:00 p.m. Lunch NUCC Open Meeting (Agenda available from NUCC) 1:00-5:00 p.m. 2

3 Attachment 1, Page 1 of 2 NUBC CHANGE CONTROL REQUEST (Return to Matt Klischer (mklischer@cms.hhs.gov) x 67488, N ) DATE: March 15, 2018 REQUESTOR ORGANIZATION NAME: Division of Institutional Claims Processing (DICP), Provider Billing Group (PBG); Center for Medicare (CM), CMS CONTACT PERSON: Wil Gehne ADDRESS: wilfried.gehne@cms.hhs.gov TELEPHONE NUMBER: PERSON(S) WHO WILL PRESENT THE CHANGE TO THE NUBC: Wil Gehne DRAFT INSTRUCTION NUMBER (PLEASE ATTACH): Pending proposed rule DESCRIPTION OF ACTION REQUESTED (e.g. additional o ccurrence code needed): Create a new value code effective January 1, 2019 to identify the county of residence of a patient receiving home health services. Short definition: County of Residence Where Service is Furnished (HHA) Usage Note: SSA State and County Code of the place of residence where the home health service is delivered. Report the number in the amount portion of the form locator, leftjustified with no space between the state code and the county code. Be sure to use the SSA State and County Codes, not the Federa l Information Processing Standards (FIPS) state and county codes. CAUSE FOR CHANGE (regulatory, data collection, other): Statutory Under current law, Original Medicare hom e health claims are paid a 3% rural add -on payment if the services are prov ided in a ru ral CBSA area. These claim s are identified using a value code 61 amount that reports the CBSA of the patient s residence. Section of the Bipartisan Budget Act of 2018 changes the law to require add-on percentage amounts to vary based on the count y of the patient s residence. The new percentages apply to hom e health epis odes ending on or after January 1, 2019 and continue (at changing levels) through

4 Attachment 1, Page 2 of 2 Section 50208(a)(2) is entitled (2) REQUIREMENT TO SUBMIT COUNTY DATA ON CLAIM FORM. and states: Section 1895(c) of the Social Security Act (42 U.S.C.1395fff(c)) is amended (C) by adding at the end the following new paragraph: (3) in the case of home health services furnished on or after January 1, 2019, the claim contains the code for the county (or equivalent area) in which the home health service was furnished. In order to comply with this law, CMS requests the NUBC create a new value code, modeled on value code 61, to carry the SSA State and County Code of the patient s residence. To avoid unnecessary burden on providers outside rural areas, CMS plans to set up Medicare systems to only require the presence of the new code if the value code 61 amount indicates a rural CBSA (i.e., the value code amount is 999xx). A list SSA State and County Codes subject to the payment adjustment will be provided in the Federal Register. IMPACT STATEMENT (current form/instr uction impacted, funding approved, implementation cost estimate, contractor operations impacted): A change request for the January 2019 Medicare system s release will be needed to im plement this new code. Costs and operations impacts will be assessed during the clearance process of that CR. NOTE: Attach any documentation th at clarifies this req uest, including documentation to support a request that is a result of a CMS mandate. Action Taken: *****DO NOT COMPLETE THIS SECTION***** Final Disposition: 4

5 X12 RFI #2274: MediCal data needs on 837 Attachment 1a, Page 1 of 4 FOR INFORMATIONAL PURPOSES ONLY Mark Carter Convener (Co chair X12N/TGC/WG2 Requests for Interpretation (RFI)) Jeffrey Jennings Requestor (California Department of Health Care Services) Description: California needs guidance on two data elements for which there is no common segment/element across the 837P, 837I & 837D. As part of Coordinated Care Initiative, California receives encounters from participating plans with dual eligible members. A Care Plan Oversight indicator is to be reported on both 837P & 837I. There is a dedicated segment on 837P, but no corresponding segment on 837I. California Medicaid is implemented on a county basis. MediCal requires managed care encounters to specify the county where a service was performed. The Service Facility Location County Code must be reported on all three 837 transactions (X222, X223 and X224). Analysis suggests two available options: #1: Use K3 segment for both Care Plan Oversight Indicator and Service Facility Location. #2: Use Demonstration Project Identifier for Care Plan Oversight Indicator on 837P&I, and use K3 segment on 837P/I/D for Service Facility Location County. Please let us know which option would be appropriate. Response: Draft The Situational Usage Rule of the Loop 2300 REF Care Plan Oversight segment within the 837 Professional X222A1 TR3 reads Required when the physician is billing Medicare for Care Plan Oversight (CPO). If not required by this implementation guide, do not send. Therefore, this segment can only be used when billing Medicare. It also does not appear that your business need is an appropriate use of the Loop 2300 REF Demonstration Project Identifier segment. Please see RFI #2213 which details the process for obtaining X12 approval for use of the K3 segment. Comments from X12 Members: Pete Anderson Since the service facility location name loop contains the city and zip code, isn't it always possible to derive the county where the service was rendered? Hence, the business need can be met without sending the county in the transaction. Mark Carter I would guess that is probably mostly true. I found this FAQ: Can ZIP Codes cross state, county, political jurisdictions and metro areas? Yes they can and do, however, this is not the norm. ZIP Codes rarely cross state lines but do more frequently cross county lines. You can see this yourself by viewing a ZIP code map. The reason for this is that ZIP Codes are service delivery areas and do not necessarily need to adhere to other geopolitical boundaries. For example, it may be more efficient to service a particular area from one post office even though it is in a different State or County. However, it s probably rarely or never true that a city AND zip code can be in two counties. 5

6 Attachment 1a, Page 2 of 4 FOR INFORMATIONAL PURPOSES ONLY Pete Anderson The good news, according to Wikipedia at least, is that there are no cities in California that span counties, although this does happen in other states. Christopher Gracon Even if a city does not span counties, the ZIP code could so a full address would need to be sent to determine which county the address is in. I know we face this challenge of determining the county a person lives in here in New York when dealing with enrollments in Medicaid. A ZIP code may be mostly in one county, but could include addresses in another county. Harvey Mintz The request states MediCal requires...the county... to address this it would be useful if the workgroup knew whether the above quoted requirement is per legislation (which might support the K3 request), per MediCal program documentation, or per the requestor's view of the problem. Jeffrey Jennings We are researching that here in California. We will also be discussing whether the county can be dependably or accurately derived from address information already on the claim. I'll have more about that soon. Pete Anderson Although I don t think the K3 requirements are met, it s the K3 process that will determine that, so I m approving with comment. LuAnn Hetherington I agree with Pete on this one. Working with the K3 process will flesh this out. Todd Omundson A new K3 segment is not necessary to meet the business need. There is a request before the NUBC to establish a new Value Code for the County of Residence Where Service is Furnished using the SSA State and County Codes. This request will be deliberated in the April 2018 NUBC meeting. This proposal obviates the need for a new K3 and can be used across all versions of the 837I. Mark Carter Thanks Todd, but those changes only address the 837I. There are probably still gaps in the 837P and 837D. The step by step K3 approval process would allow TGB/WG2 to evaluate if there is existing functionality in all the 837 TR3's and if changes need to be made for future versions as well as whether or not to approve a K3 usage for any 5010 TR3. 6

7 Attachment 1a, Page 3 of 4 FOR INFORMATIONAL PURPOSES ONLY Gail Kocher The text of the request indicates the need is for the 837P and 837I. Any K3 request should not be processed as complete prior to the NUBC's adjudication of their request. It would not be appropriate for X12 to create a methodology that is different or conflicts with the NUBC's disposition. Creating multiple ways to do one thing creates ambiguity for all stakeholders. This is about doing the right thing for all not about finishing something to say it was done. Much more information is needed in order to truly evaluate what the real business need is. Jeffrey Jennings California is looking for ways to resolve the reporting requirements that drove this RFI in the first place. We are working with the business units that requested the CPO and County reporting to understand the actual business needs surrounding that. Both reporting requirements were set in the past, and it may be they are no longer required. California is fine waiting for the NUBC request to be adjudicated. We are revisiting the CPO requirement, which arose in relation to the ongoing Duals demonstration. California submitted this RFI to seek guidance on the right solution, and do not advocate finishing something to say it was done. Not even sure where that came up, as we did not indicate any sort of timeline or rush. Gail Kocher The comment about finishing to say it is done is related to X12 moving forward before the NUBC completes their work. There is also to my knowledge no formal K3 request on the table anyway. Jeffrey Jennings Thanks for the clarification. Just wanted to be clear on California's position. As stated, we are in agreement with waiting on NUBC. Mark Carter So, is California willing to withdraw this RFI in light of the NUBC activity and re visit a possible new RFI or Change Request after NUBC acts? Jeffrey Jennings I'm starting to think that. I ve just now received some further information regarding the Care Plan Oversight indicator that also changes the RFI. I will confirm that California is withdrawing this RFI in the next hour or so. Jeffrey Jennings Mark, California is going to withdraw RFI 2274 in light of clarifying information just received regarding the CPO, and also to await the NUBC adjudication regarding counties. When we have more information about the CPO, a new RFI may be submitted. We appreciate the support and commentary on this. Is there any additional action needed on California's part to withdraw the RFI? Please advise. Thank you! Mark Carter Thanks Jefferey, no problem. I'll let our Portal Screener know. It looks like you were the submitter. Is that correct? 7

8 Attachment 1a, Page 4 of 4 FOR INFORMATIONAL PURPOSES ONLY Jeffrey Jennings Yes sir, I was the submitter. Thanks again. If we do submit a future RFI regarding this, it will be more specific. Thanks to all in the group who commented. David A. Feinberg For everybody's information, I did a quick search of the Internet, and right off the bat found the following web site: county am i in.php There are probably more such sites that can give you the county an address is located in. 8

9 Attachment 2, Page 1 of 28 Cellular Therapy Recent advances in gene therapy and genome treatments are rapidly growing. We want to bring forward for NUBC consideration suggested changes to the UB data set and launch a discussion on how best to accommodate reporting of some of the key elements associated with these new curative strategies that apply gene therapy modalities. For example, Chimeric antigen receptor (CAR) T-cell therapy is an immunotherapy in which a patient s own T cells are genetically engineered to seek and destroy cancer cells. The patient s cells are isolated in the lab, redirected with a synthetic receptor to recognize a particular antigen or protein, and then intravenously re-infused to the patient. CAR T therapeutics are manufactured specifically for each individual patient. Two CAR T blood cancer therapies have been approved so far by the FDA 1. Novartis Kymriah was approved in August 2017 and Kite s Yescarta in October Kymriah's initial FDA approval is for a narrow group of patients -- children and young adults with a specific blood cancer. Yescarta became the first CAR T therapy approved by the FDA for the treatment of adult patients with non-hodgkin lymphoma. The issue is that these products are extremely expensive -- $475,000 for Kymriah and $373,000 for Yescarta. Billing Considerations for the NUBC At this stage, the NUBC is most interested in health plans view on establishing a common billing approach that captures many of the key components for this therapy. Outlined below are items to consider. Procedure Codes Most patients will be inpatient. Two new ICD-10-PCS codes have been assigned for these CAR T therapies, but no CPT/HCPCS codes. A formal request for new CPT codes was recently submitted to the AMA CPT Panel. The request included codes for: Collection of the cells that are sent to the manufacturer for genetic engineering Cryopreservation of the cells prior to transport to manufacturer Thawing of cells after receipt of cells from manufacturer Intravenous administration of CAR T Revenue Codes The prescription cancer products are not handled by the hospital pharmacy department (revenue categories 025x, 063x). Rather, in most hospitals, the product is handled by the cell transplantation department that currently administers stem cell transplants. The department responsible for CAR T cell therapies and products will require staff with special training and expertise. Typically these services also require specialized sterile accommodations along with specialized nursing and caregivers. Pharmaceutical manufacturers are continuing to develop new gene therapies and products 1. Accordingly, would a new revenue code(s) series to capture the accommodation piece for these therapies seem appropriate? DRAFT 1 Note that in December 2017, the FDA approved Spark Therapeutics Inc.'s Luxturna, a non-car T prescription gene therapy product administered by subretinal injection used for the treatment of patients with inherited retinal disease. The cost is $850,000 or $425,000 per eye. 9

10 Attachment 2, Page 2 of 28 There will also be special handling and storage expenses to ready and preserve the gathered cells for shipment and later gene manipulation. These would include transportation to/from the manufacturer along with labeling and relabeling with each transfer. To record these expenses, should we look to a new subcategories series that could be added to revenue code 039x - Administration, Processing, and Storage for Blood and Blood Components? Currently there are six reserved subcategories. Revenue Code Other Blood Handling could also be broken out. The CAR T cell therapies are multi-step processes beginning as an inpatient to harvest the cells, proper packaging and shipping, and then once the cells are manipulated and sent back they are ready for re-introduction/infusion to the patient. Once the patient receives the modified cells the patient must stay within 2 hours of the location where they received their treatment for at least 4 weeks after infusion in order to evaluate whether the treatment is working and to monitor any side effects. This necessitates residence arrangements similar to accommodations for continuous outpatient care. If a hospital sets aside a unit with medical assistants and meals delivered, it would not be a hospital level of care rather continuous outpatient care. Currently we have revenue code 0671 Hospital Owned Outpatient Special Residence Charges. Would this be the appropriate revenue code to capture these services or should we consider a new revenue code? Value Code Normally an NDC number would be reported along with the invoice price on each revenue code line. However, a significant concern is the matter of charge compression and cost-to-charge ratio distortion especially when they are co-mingled into one cost center on the cost report. This could be alleviated by designating new cost center to capture such services on the Medicare cost report. Additionally, is there a need to establish a new value code to report the invoice cost of the genetically modified drug/biologic reported on the claim? (As indicated earlier the cost to the hospital from the manufacturer for these services is extremely high). DRAFT 10

11 Attachment 2, Page 3 of 28 September 6, 2017 Administrator Seema Verma Centers for Medicare & Medicaid Services, Department of Health and Human Services, Mail Stop C , 7500 Security Boulevard, Baltimore, MD Cc: Carol Blackford Tiffany Swygert Ryan Howe NewTech@cms.hhs.gov Re: CMS Payment Models for Chimeric Antigen Receptor T Cell (CAR-T) Therapy Administrator Verma: The American Society for Blood and Marrow Transplantation (ASBMT) is an international professional membership association of more than 2,200 physicians, scientists and other healthcare professionals promoting blood and marrow transplantation and cellular therapy research, education, scholarly publication and clinical standards. ASBMT is dedicated to improving the application and success of blood and marrow transplantation and ensuring access to all patients who need hematopoietic cell transplants and cellular therapies such as CAR-T. Hematopoietic cell transplantation (HCT) is a medical sub-specialty comprised of physicians with Board Certifications in Internal Medicine, Medical Oncology, Pediatrics, Hematology and/or Immunology. CMS recognized the unique role and qualifications of HCT physicians by designating a unique code for Hematopoietic Cell Transplant and Cell Therapy (HCTCT) physicians in November Due to their unique clinical expertise and training, ASBMT member clinicians and cellular therapy programs will be the primary individuals and teams initially providing Chimeric Antigen Receptor T Cell Therapy (CAR-T) to patients in need of 1 CMS MLN Matters MM957 1 ASBMT CAR-T Letter to CMS September

12 Attachment 2, Page 4 of 28 treatment. We anticipate that CAR-T is the first of what is expected to be many engineered cellular therapies that are expected to outpace traditional oncology treatments in the coming decade. We concur with the expert commentary labeling cellular therapies as the key breakthrough therapy of the 21 st Century, as discussed at the July 13, 2017 FDA Oncology Drugs Advisory Committee. 2 Due to the involvement of our membership and the coming wave of innovation that these cellular therapies represent, the ASBMT is keenly interested in the reimbursement models that will be applied to these technologies on behalf of our members. Given the very recent approval of the Novartis CAR-T product, Kymriah, and the anticipated future approval of Kite Pharma s Axi-Cel, ASBMT has assessed the current reimbursement policies for anticipated impact to facilities providing CAR-T and we provide our commentary and suggestions to CMS throughout the remainder of this letter. On August 30, both Novartis and CMS issued public statements that the two organizations will be working together to develop innovative payment models for CAR-T. ASBMT acknowledges that new models for cellular therapy are likely necessary and we welcome any opportunity to engage with CMS on the development of these models. While most of the issues and proposed solutions in this letter are based on current payment policy tools vs. entirely new payment structures, they would be useful in serving as interim steps to assure access to CAR-T for Medicare beneficiaries while more complex methodologies are being developed. We have also received questions and comments from our members regarding the announcement of potential innovative payment methodologies, which are detailed later in this letter. Summary of Request On behalf of our membership, we request that CMS consider its authority to create off-cycle modifications to the inpatient payment system in order to ensure that CAR-T is available to Medicare beneficiaries. In addition, we ask that CMS create new codes in order to adequately describe services being provided and to track the associated costs, as well as issue interim billing and coding guidance for provider use during the period before new codes are approved and available. Background Information on CAR-T The most simplistic explanation of CAR-T is the following, as described by the National Institutes of Health: 2 FDA ODAC Meeting, July 13, ASBMT CAR-T Letter to CMS September

13 Attachment 2, Page 5 of 28 As its name implies, the backbone of CAR-T-cell therapy is T cells, which are often called the workhorses of the immune system because of their critical role in orchestrating the immune response and killing cells infected by pathogens. The therapy requires drawing blood from patients and separating out the T cells. Next, using a disarmed virus, the T cells are genetically engineered to produce receptors on their surface called chimeric antigen receptors, or CARs. 3 From the patient treatment perspective, the process is as follows: 1) Patient is diagnosed with qualifying condition and is referred to treatment center. 2) Patient travels to treatment center for initial consultation and treatment planning; returns home or remains at treatment center for on-going treatment of disease. 3) Patient travels to treatment center to have cells removed through a process called autologous apheresis or leukapheresis; this may be conducted in either the inpatient or outpatient setting. 4) The hospital places order for production and ships patient cells to manufacturer; patient likely returns home for 2-3 weeks during the CAR-T production process. 5) Up until for infusion of CAR-T product, the patient will likely be receiving chemotherapy to control disease progression. This may be administered inpatient or outpatient. 6) Patient travels to treatment center for infusion of the CAR-T product after being notified of successful manufacturing and estimated arrival date. 7) Patient is admitted for preparatory lymphodepleting chemotherapy and CAR-T infusion. The patient remains in the hospital for days, depending on the patient s individual response and until the treating physician team feels confident that the patient is not experiencing moderate to severe complications. Outpatient provision of CAR-T will likely be available in limited sites for specific patients but will not be common during the initial post-approval period. 8) For approximately 15-30% of patients of patients, moderate to severe complications will result in staying in the hospital for up to 3 weeks as symptoms are being treated. Cytokine Release Syndrome (CRS) symptoms will begin appearing in affected individuals within 2-7 days after infusion with the product and neurotoxicity typically appears within 5-7 days of infusion. 9) Patient remains nearby the treatment center for an additional 1-2 weeks for monitoring. 10) Patient returns home for on-going monitoring with local clinical teams. 3 3 ASBMT CAR-T Letter to CMS September

14 Attachment 2, Page 6 of 28 Complications: After infusion of the CAR-T product, patients have a moderate risk of complications that require additional inpatient care and support. CRS is a group of systemic reactions due to the high volume of cytokines released from cells targeted by the engineered T- cells; symptoms include fever, fatigue, and pulmonary and cardiac changes. 45 In addition to CRS, patients may experience neurotoxicity of varying degrees ranging from mild confusion to the inability to speak and unconsciousness. Uniform systems of grading these complications are forthcoming and complications vary by product and treatment population, but it is expected that somewhere between 15-30% of patients will experience Grades 3-4 CRS and/or neurotoxicity. To treat these symptoms, the clinical teams use various combinations of corticosteroids, supportive interventions and immunosuppressive medications, such as Tocilizumab. Prior to FDA approval of Actemra/Tocilizumab for treatment of CRS, hospital acquisition costs were reported by member pharmacists to be $5,000-10,000 per therapeutic dose, depending on the patient, and frequently needs to be administered 2-5 times. We anticipate this number will increase after the noted approval. Patients experiencing complications are frequently relocated to the Intensive Care Units at the first sign of these symptoms and are treated there until symptoms abate. These complication-driven additional therapeutic interventions will add additional costs to the inpatient episode that are not typical expenses for patients being treated for lymphoma. Products and Timeline: There are two CAR-T products expected to receive FDA approval in the 2017 calendar year. Novartis CTL019 product, Kymriah, was approved on August 30, 2017 for B-cell acute lymphoblastic leukemia (ALL) in patients up to age 25. Of more relevance to CMS and the Medicare beneficiary population is Kite Pharma s CAR-T product - axicabtagene ciloleucel (Axi-Cel) - expected to gain FDA approval in the third quarter of The initial clinical indications for Axi-Cel are Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma and Transformed Follicular Lymphoma, all sub-types of lymphoma most commonly diagnosed in older adults, including the Medicare beneficiary population. Medicare Beneficiary Access to CAR-T Therapies Predominantly Inpatient Care Setting Creates Reimbursement Concerns 4 Cytokine Release Syndrome: Overview and Nursing Implications 5 Neelapu et al, Nature Reviews Clinical Oncology, Fall 2017, publication in press 4 ASBMT CAR-T Letter to CMS September

15 Attachment 2, Page 7 of 28 We have received many reimbursement related questions from member clinicians and cell therapy programs undergoing financial planning exercises focused on the provision of CAR-T to beneficiaries. A poll of ASBMT member experts those physicians that have been in charge of delivering CAR-T during the clinical trial process indicates that all are planning to keep patients in the inpatient setting for at least 7 days after infusion to monitor for complications. Given the intensive use of the inpatient setting for this therapy, hospitals are rightly concerned about how CMS will reimburse for the provision of CAR-T. CAR-T is not presently eligible for a new technology add-on payment (NTAP) due to the annual cycle timeframe utilized by CMS. Additionally, the vast majority of costs, such as product costs, infusion cost, and post-treatment complication costs will likely be concentrated within the infusion inpatient stay. As it currently stands, this inpatient stay will be assigned to one of a few possible MS-DRGs, all of which have payment rates that will be grossly inadequate in their reimbursement of provider cost. As outlined in more detail in the following sections, we are deeply concerned that the use of a very expensive new product without provision for additional new technology payment may result in limited beneficiary access. Therefore, we ask that CMS utilize its authority under Section 1886(d)(5)(I) of the Social Security Act, which allows it to "provide by regulation for such other exceptions and adjustments to such payment amounts under [IPPS] as the Secretary deems appropriate so that CMS may pay appropriately for this important new therapy in FY We strongly believe that a unique interim solution is necessary until such time as the agency has the opportunity to develop an innovative payment model or evaluate actual CAR-T claims data to determine the need for new/separate MS-DRGs. The ASBMT is prepared to work collaboratively with CMS to both present and discuss possible policy alternatives. Limited Facilities for CAR-T Provision Manufacturers have stated publicly 6 that only a very limited number of facilities likely between for the first year and up to 90 by the end of year 3 will be approved for participation in the production and infusion process for CAR-T. 7 This means that patients from the entire United States will be directed to a relatively small number of facilities to receive treatment. Given the intensive requirements needed for proper patient management and monitoring, it is clinically appropriate that only a limited number of facilities will offer this new therapy at the outset. 6 FDA ODAC Novartis Hearing, July 12, 2017; Kite Pharma 2nd Quarter Earnings Call, August 8, Kymriah Treatment Sites, September 3, ASBMT CAR-T Letter to CMS September

16 Attachment 2, Page 8 of 28 However, this also means that this limited group of facilities will be disproportionately impacted by the expected reimbursement deficits in a concentrated manner. If even a small percentage of these facilities decide that the financial burden of treating Medicare patients with CAR-T is more than they can sustain financially, then access could become a serious problem if patients seeking care begin to have fewer locations available. Therefore, we are asking CMS to carefully examine the access implications that its current reimbursement policies will likely have on the small number of facilities that will be administering this new therapy. Problematic Acquisition Costs and FY2018 MS-DRG Groupings CAR-T is expected to be an extremely cost-intensive therapy to provide, due to two key aspects of the treatment; 1) the cost of acquiring the personalized product from the manufacturer and 2) the cost of treating the complications that are expected to arise in a subset of patients. Novartis has announced the Kymriah will be priced at $475, This pricing is just for the engineered cells (i.e., the product itself) and does not include any other patient care provision and expense. Other costs the facility incurs include inpatient nursing and infusion administration and if postinfusion complications occur, treatment costs will also be borne by the facility. Without a clear sense of which MS-DRG(s) these patients are likely to fall into, facilities are unsure what type of reimbursement they may receive. Earlier in its 2017 response to the proposed new ICD-10-PCS codes, ASBMT requested CMS assign all CAR-T care episodes to MS-DRG 837 (Chemotherapy with Acute Leukemia as Secondary Diagnosis or with High Dose Chemotherapeutic Agent with MCC) and MS-DRG 838 (Chemotherapy with Acute Leukemia as Secondary Diagnosis with CC or High Dose Chemotherapeutic Agent), as these MS-DRGs could be considered clinically appropriate for the intensity of care being provided when administering CAR-T, even if they does not fully capture the resources used during these episodes of care. While the description of the MS-DRGs is not an exact match, it may be the nearest non-surgical comparator. As stated in our letter, CMS has precedent for making this kind of intensity-matched MS-DRG placement (see Addendum A). CMS did not provide additional commentary on this request in the proposed or final IPPS rule. In the FY18 IPPS Final Rule, the CAR-T new technology ICD-10-PCS code was identified as a non-operating Room procedure (Table 6P.4o). While this categorization is clinically correct, the 8 Bloomberg, August 31, ASBMT CAR-T Letter to CMS September

17 Attachment 2, Page 9 of 28 lack of O.R. designation subsequently results in lack of Pre-MDC direction to a specific set of MS-DRGs. Thus, CAR-T lymphoma cases will likely group to one of a few non-surgical MS- DRGs depending on the constellation of diagnosis and procedure codes reported on the claim. The use of a pre-mdc assignment mechanism for CAR-T cases would enable CMS to route these clinically complex and resource-intense cases to a specific set of MS-DRGs and is something we believe should be considered. The lack of clarity as to which MS-DRG a facility can expect to be assigned to its CAR-T creates unknown financial risk for hospital finance departments and executive staff to attempt to evaluate on their own. As the initial indications for the use of Axi-Cel are for subtypes of non-hodgkin lymphoma and there will be no surgical procedure routinely provided during the care episode, our assessment of the most likely medical MS-DRG assignments for CAR-T cases are those listed below. Table 1: Potential MS-DRG for CAR-T Inpatient Stays Based on Current Grouper Logic MS-DRG MDC Type Title Weights Approximate Base Reimbursement MED LYMPHOMA & NON-ACUTE LEUKEMIA W MCC MED LYMPHOMA & NON-ACUTE LEUKEMIA W CC MED LYMPHOMA & NON-ACUTE LEUKEMIA W/O CC/MCC 7 ASBMT CAR-T Letter to CMS September Geo Mean LOS $16, $8, $6, These MS-DRGs are not accurate matches for clinical provision of CAR-T, particularly when considering the expected length of stay for CAR-T patients, but they reflect the most likely assignment given CMS s DRG assignment process. As mentioned earlier, ASBMT would like CMS to exercise its authority under Section 1886(d)(5)(I) of the Social Security Act, which allows CMS to "provide by regulation for such other exceptions and adjustments to such payment amounts under [IPPS] as the Secretary deems appropriate." We strongly believe CMS must make some sort of proactive adjustments for CAR-T payment for FY2018 given that one product has received FDA and another is expected to in the coming months. We believe CMS can either exercise its authority and create one or more new MS-DRGs for CAR-T for FY 2018 and/or implement another mechanism by which the product costs are evaluated and paid on a reasonable cost basis. ASBMT has identified one pathway that we outline below for CMS s consideration to take steps to protect access to care

18 Attachment 2, Page 10 of 28 and financially protect hospitals using existing mechanisms, implemented in way specific to the current clinical requirements of CAR-T. There is precedent for CMS to make a DRG grouping decision in advance of the FDA approval of a new technology. In 2003, CMS created new DRGs 526 and 527 at the time of introduction of drug-eluting stents (DES) in order to recognize the additional expense of this new technology, even prior to formal FDA approval. ASBMT asks that CMS mirror this policy initiative and create new MS-DRGs for the administration of CAR-T, including potential adjustment for the presence and severity of complications. At the time of the off-cycle creation of new MS-DRGS for DES, they did not pass the cost threshold criterion for the NTAP, but the adoption of DES was expected to be so widespread that CMS created two new DRGs prior to the anticipated FDA approval of DES devices. Given that it would not be unique, we ask CMS to consider making a similar exception with CAR-T, particularly since it would meet the cost criterion for NTAP designation and separate MS-DRG assignment. While its initial use will not be widespread as DES, the expected clinical benefit is very large and the cost of product acquisition is such that we believe CMS should give this new technology special consideration. New Technology Add-on Payment Essential for Initial Post-Approval Period Kite Pharma applied for a New Technology Add-on Payment for Axi-Cel for the FY2018 cycle, as described in the FY18 IPPS Proposed Rule. ASBMT submitted comments in support of Axi- Cel qualifying as a new technology, which are included in Addendum B of this document. As noted in the FY18 IPPS Final Rule, Kite Pharma withdrew its application when its product did not receive FDA approval by CMS s July 1 st procedural deadline. While we understand CMS s timeline, we are concerned about the significant financial losses expected for the facilities providing Axi-Cel as a therapy to beneficiaries in the future (FDA approval is expected in late Fall 2017). We expect losses in the range of multiple hundreds of thousands of dollars given the expected cost of the personalized product as well as the resources involved to infuse and care for the patient as outlined earlier. When appropriate to provide in the outpatient setting, our understanding is that providers would be reimbursed for Axi-Cel as a pass-through drug, at the standard payment level of ASP +6%. Given that much of the initial provision of CAR-T will take place in the IPPS setting, current 8 ASBMT CAR-T Letter to CMS September

19 Attachment 2, Page 11 of 28 CMS payment policy creates a reimbursement deficiency based on site of care, which the Agency has previously stated it is looking to minimize. While cancer centers want to provide beneficiaries with the best possible care, centers may simply be unable to absorb the large financial losses that are likely for CAR-T under CMS current reimbursement system. This is one reason why we ask CMS to exercise its authority and at a minimum, award Axi-Cel with NTAP status at the time of FDA approval despite this action being outside of its usual process timeline. While, as stated in our previous NTAP comments, we believe that Novartis s Kymriah would qualify as a substantially similar product, we understand and acknowledge that Novartis did not apply for NTAP in the FY2018 cycle. We believe CMS can exercise its authority and provide adequate reimbursement for a therapy which for beneficiaries who meet the clinical qualifications for treatment with Axi-Cel, there are no alternative therapies other than the provision of supportive care. We strongly believe Medicare beneficiaries should be afforded immediate access to CAR-T and ask CMS to find a way to support facilities that will be providing this care. Charge Compression and Outlier Payment Implications As cellular therapies are being touted as one of the most significant breakthrough medical advances in the 21 st century, there has been and will continue to be much public and private scrutiny on the cost, reimbursement, and outcomes related to these therapies, beginning with CAR-T. Combining the known product cost of $475,000 for Kymriah (and an assumed relative comparator for the Axi-Cel) and our knowledge of hospital coding, billing, and charging practices for high cost items/services such as drugs, devices, and cell acquisition costs for unrelated donor cells, we do not believe hospitals will mark up their invoice cost by their standard pharmacy or other cost-to-charge ratios (CCRs) when billing CMS or other payers. CMS s current inpatient cost outlier and MS-DRG rate-setting method relies on hospital charges multiplied by cost-to-charge ratios (CCRs). For rate setting, CMS aggregates the cases into the MS-DRGs and groups the charges by revenue code and then reduces them to cost using one of 19 national CCRs. For CMS s methodology to yield an accurate estimation of cost from provider billed charges, providers must mark up their costs. Tthe cost to the provider for the CAR-T product is $475,000, as stated by Novartis. The provider will pay this cost to the manufacturer and will need to represent this cost to CMS on its claim in the form of a dollar 9 ASBMT CAR-T Letter to CMS September

20 Attachment 2, Page 12 of 28 charge. The best way to do this would be for the provider to mark-up the $475,000 cost by its own drug or overall CCR based on its cost report. For illustrative purposes, assume the provider s drug CCR is similar to the FY2018 IPPS national average CCR for the drug cost group (0.194). This means the hospital would have to mark-up (i.e., divide) its $475,000 invoice cost by to report a line item billed charge of $2,448,453 just for the product. Without billing CMS this marked-up charge, providers will not see the costs of CAR-T reflected in future MS-DRG payment rates, nor will the provider be able to generate an appropriate outlier payment for this type of case at the point of current billing and reimbursement. The odds of providers reporting such an extraordinarily high single charge is extremely slim, given concerns that the patient, other payers, and CMS s own MACs might express. At best, such a high dollar charge might be seen as an error, and, at worst, as an egregious act of over-charging. Yet a hospital would be within its rights to apply such a mark-up if it reasonably relates to its costs and reflects CMS s current IPPS rate setting and cost outlier methodologies. As hospitals are not likely to mark up their invoice costs in this a manner, they will likely not generate the type of outlier payment they might otherwise resulting in inadequate current reimbursement and in an incorrect picture of true cost to be factored into future reimbursement rates for this breakthrough therapy which is bound to create barriers to access. The charge compression we anticipate for CAR T is likely to be much worse than what we ve experienced to date for implantable devices and the MRI, CT and cardiac catheterization cost centers. Utilizing current reimbursement methodologies without the use of NTAP, a modification to the outlier formula, the creation of new MS-DRGs, cost reimbursement in the early years of CAR-T, or some other mechanism will create tremendous challenges to those providers who wish to bring this new technology to the appropriate subset of beneficiaries. As noted above, only a small number of providers will be performing CAR-T from the start, and while some of these will be the PPS-exempt cancer centers, it should be noted that they will face a similar financial impact despite their exemption. This is because neither the NTAP nor IPPS cost outlier payment is available to them. These centers are paid for inpatient cases based on a TEFRA per case rate which is set at a specific period in time and periodically rebased. It is very likely that the provision of CAR-T could result in an exempt center exceeding their rate. While exemptions to the rate can be granted, these cannot be requested until after a full cost-report year is finalized and settled, which can be several years after the date of discharge for the case. 10 ASBMT CAR-T Letter to CMS September

21 Attachment 2, Page 13 of 28 Therefore, policy remedies as mentioned above are needed for all providers of CAR-T, including the PPS exempt cancer providers. New Revenue Codes and Cost Center In anticipation of the significant charge compression for CAR-T described previously, as well as successive cellular therapy products expected to be FDA approved in the coming years, ASBMT is planning to ask the National Uniform Billing Committee (NUBC) for a new, dedicated revenue code series for cellular therapy products. We believe this is necessary from the outset to clearly identify these products as unique from traditional drugs and antineoplastic agents. This is particularly important on inpatient claims where drug-specific HCPCS code and/or NDC code are not routinely billed to the Medicare program. Along with the new revenue code series, ASBMT is requesting CMS establish a dedicated cost center for cellular therapy products, beginning with CAR-T. Neither of the above is unlike what CMS recently did for stem cell transplants (i.e., new revenue code 0815 and new cost center line 77). We strongly believe this approach will help ensure that CAR-T and future cellular therapy products are protected from the outset from the well-known problems associated with charge compression and other rate setting anomalies. Finally, the ASBMT strongly urges CMS to consider developing a 20 th IPPS rate-setting cost group for cellular therapy using the information collected from the new revenue code and new cost center. This will enable CMS and the public to isolate this very new and extremely expensive therapy. CMS will have exercised considerable foresight if it anticipates these issues now and proactively plans to account for them in its rate-setting methodology from the outset. New Codes Needed for Reimbursement and Tracking The ASBMT has been working with providers and coding experts to identify the most appropriate ICD-10-PCS and CPT codes to describe the various steps involved in the use of CAR-T; namely the collection and infusion of cells, though there are also other steps that may be involved. Starting October 1, 2018, providers will be able to report CAR T infusion administration provided in the inpatient setting with a new ICD-10-PCS code. Until that time, facilities will have to exercise their judgement and report the next best code available. 11 ASBMT CAR-T Letter to CMS September

22 Attachment 2, Page 14 of 28 The following codes are lacking: - Collection of autologous cells for the purpose of CAR-T manufacturing (similar collection procedure codes are explicitly defined as for the purpose of HCT) - Infusion/Administration of the CAR-T product into the patient - Product specific J codes and/or temporary Q codes until J codes are available We acknowledge there are codes that may work for an interim time period as substitutes for new and specific codes, but we believe this requires discussion with CMS and/or CPT to create clarity and consistency in the use of alternate codes so that these services do not inappropriately affect non-car-t APC calculations in upcoming years. In addition to clarifying interim codes for use, we believe it will be necessary for CMS to release G-codes to describe the various procedural steps involved in CAR-T due to the cost and unique aspects of care delivery associated with these products. We ask that CMS consider issuance G-codes very soon so they are available by January 1, 2018, as well as issuing guidance on interim coding procedures. Innovative Payment Model for CAR-T On August 30, 2017, Novartis and CMS issued public statements regarding alternative payment models for CAR-T in the Medicare beneficiary population. The ASBMT supports innovative thinking about reimbursement for the provision for CAR-T due to all of the reasons outlined in this letter. Novartis indicated that reimbursement would only be applicable in cases where the patient shows a response to Kymriah at 30 days after provision. Below, we summarize the comments and questions we have received from our member clinicians and administrative staff since the public commentary on this potential mechanism. Response Determination: A third-party organization should be involved with the determination of response levels that would indicate payment is needed. Accurate and time-sensitive individual analyses will be needed. Publicly reported aggregate outcomes should be considered. The Center for International Blood and Marrow Transplant Research (CIBMTR) is a qualified potential resource for evaluating clinical responses. Historically, response assessment for therapies for hematologic malignancies have been assess at intervals well beyond 30 days. HCT is assessed for efficacy at 100 days, 6 months and 1 year after transplantation. We encourage open and public dialogue in determining the appropriate response timeline for CAR-T products. A certain percentage of CAR-T patients will relapse within a few months of treatment and will need to be either re-treated with CAR-T or receive HCT to attempt to gain a 12 ASBMT CAR-T Letter to CMS September

23 Attachment 2, Page 15 of 28 more secure remission or cure. In these cases, the valuation of the efficacy of the initial product, and corresponding payment, may need to be adjusted accordingly. Financial Implications: Hospitals should not be held financially liable for the care provided to patients receiving CAR-T if the patient does not experience a response warranting payment for the product. A significant amount of resources will be utilized by the facility in advance of the Day 30 outcome evaluation and those services should be reimbursed by CMS. Hospitals should not be asked to pay for a product at the time of use if reimbursement for the product purchase will be determined at Day 30. Movement of significant dollars to and from the manufacturer in a short period of time will create financial reporting issues for facilities and may take the funds away from other patient care needs. Summary and Contacts ASBMT has gathered a cohort of provider, payer and manufacturer stakeholders that are helping to identify and resolve issues related to access, coding, billing, and reimbursement for CAR-T. We welcome the opportunity to discuss identified issues with CMS in hopes that the agency will choose to utilize its authority under the law to create appropriate reimbursement mechanisms outside of CMS s normal rate-setting schedule. CAR-T is a transformative therapy for the field of oncology and ASBMT is committed to making it available to beneficiaries that may benefit. ASBMT peer-elected leaders, member clinicians and policy staff are available as a resource for CMS staff when issues associated with HCT, CAR-T and other cellular therapies are raised internally in the future. Please do not hesitate to reach out whenever we may be of assistance. Krishna Komanduri, MD ASBMT President, Health Policy Staff Contact: Stephanie Farnia, Director, Health Policy; StephanieFarnia@asbmt.org; (847) ASBMT CAR-T Letter to CMS September

24 Attachment 2, Page 16 of 28 Addendum A: Excerpt from Previous ASBMT Comment Letter on ICD-10-PCS Codes CMS Precedent for Inclusion of High-Dose Interleukin Treatment in MS-DRG 837/838 As is described in the following excerpt from the Inpatient Prospective Payment System Fiscal Year 2008 Final Rule, CMS acknowledges this same issue during the early use of HD-IL-2 and clarifies that antineoplastic care episodes utilizing HD-IL-2 should be assigned to a MS-DRG more reflective of the resources utilized during the provision of care. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 411, 412, 413, and 489 [CMS-1533-FC] RIN 0938-AO70 Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates Payment/AcuteInpatientPPS/downloads/CMS-1533-FC.pdf Administration of high-dose Interleukin-2 (HD-IL-2) is a hospital inpatient-based regimen that can produce durable remissions of metastatic renal cell cancer and metastatic melanoma in a subset of patients. In contrast to traditional cytotoxic chemotherapies which target cancer cells directly, HD-IL-2 enhances the body s natural cancer defenses by stimulating the growth and activity of cancer-killing white blood cells. HD-IL-2 therapy is associated with severe complications that can include: hypotension, metabolic acidosis, acute renal failure, arrhythmia, myocardial inflammation, coagulation defects, hyperthyroidism, psychosis, respiratory distress syndrome, catheter related septicemia, hyperbilirubinemia and thrombocytopenia. To safely administer HD-IL-2, the FDA-approved label states that HD-IL-2 should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available. Strict nursing protocols must be followed in order to minimize adverse events such as cardiac arrhythmias as well as severe hypotension. Because it is associated with such severe side effects, HD-IL-2 therapy requires substantially greater resource utilization, including longer hospital stays and additional nursing support, than conventional chemotherapy. Conventional chemotherapy may be administered to patients either on an outpatient basis or through a series of short (that is, 1 to 3 day) inpatient stays. In spite of the possibility of erroneous coding of low-dose IL-2 cases to procedure code instead of the more appropriate code as discussed above, the data do not currently suggest a problem with Medicare payment for most of the HD-IL-2 cases assigned to MS-DRGs 837, 838, and 839. However, the data do suggest that the costs of cases of IL-2 coded with ASBMT CAR-T Letter to CMS September

25 Attachment 2, Page 17 of 28 currently assigned to MS-DRG 839 are closer to MS-DRG 838. Therefore, for FY 2008, we are assigning procedure code (High-dose infusion of Interleukin-2 (IL-2)) to MS-DRG 837 (Chemotherapy with Acute Leukemia as Secondary Diagnosis or with High Dose Chemotherapeutic Agent with MCC) and MS-DRG 838 (Chemotherapy with Acute Leukemia as Secondary Diagnosis with CC or High Dose Chemotherapeutic Agent). Addendum B: Except from ASBMT FY2018 IPPS Comment Letter As submitted on June 10, 2017 I. New Technology Add-on Payments for HCT and Cellular Therapies In Section H of CMS-1677-P, CMS asks for commentary on several drugs or devices pending renewed or initial acceptance as new technologies warranting add-on payment status. Per page 311 of the Proposed Rule, there are three criteria that a new medical service or technology must satisfy to be considered eligible to receive the additional payment: (1) the medical service or technology must be new; (2) the medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. a. Axicabtagene Ciloleucel (KTE-C19) In Section H.d. (pp ), CMS summarizes the application submitted by the manufacturer of KTE-C19 and asks for public comments on whether the product meets the criterion for both newness/substantial similarity and substantial clinical improvement. The ASBMT feels that KTE-C19, and other Chimeric Antigen Receptor T Cell (CAR T) technologies, meet all criterion for New Technology status for the reasons outlined in the following sections. Our comments pertain to Chimeric Antigen Receptor Cellular Therapies as a class of products, of which KTE-C19 is the first to apply for a New Technology Add-On Payment for an engineered T Cell-based treatment. If KTE-C19 does not gain FDA approval by the July 1 timeline requirement for FY18 IPPS NTAP status, we maintain our position on the qualification of CAR Cellular therapies for NTAP status as it would pertain to any subsequent product application(s). 15 ASBMT CAR-T Letter to CMS September

26 Attachment 2, Page 18 of 28 Newness & Substantial Similarity: CMS evaluates technologies for NTAP status within the context of potential substantial similarity to other treatments. Specifically, new services or technologies are evaluated for the following: (1) whether a product uses the same or similar mechanism of action, (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population (p. 312). The ASBMT feels definitively that KTE-C19, and similar engineered Cellular based therapies, should be considered a new technology and that they are not substantially similar to any other therapy currently available. Mechanism of Action: While CMS makes a correct assessment that KTE-C19 (CAR T) and bispecific T cell engager technology (BiTE) are both therapies that target CD19 antigens expressed by lymphoma and leukemia cells, they are wholly different compounds and different approaches to immunotherapy of CD19+ malignancies. There are significant differences between the technologies in both their mechanism of action and the logistics of their delivery to the patient; overall, CAR T (KTE-C19) is a novel therapy unlike any previously developed for patients with blood cancers. BiTE technologies, such as Blincyto, are constructed monoclonal antibodies, while KTE-C19 therapy is based on transferring a molecularly engineered receptor, or chimeric antigen receptor (CAR), into cells (autologous T cells), which are then infused into the patient. These cells are genetically altered to express the CAR molecule on their surface. They are grown (expanded) in culture over several days and prepared for infusion into the patient. The CAR T cells then circulate and when they come upon the target antigen present on tumor cells - CD19 - they activate, expand, produce cytokines, and destroy their tumor targets. A CAR is a synthetic protein typically composed of three different domains, including (1) an antigen-recognition domain linked to (2) a transmembrane domain, and (3) an intracellular domain containing intracellular costimulatory molecules and a signaling molecule. To generate autologous CAR T cells, the patient undergoes a process, known as leukapheresis, in which blood is removed from the patient s veins in an outpatient procedure, similar to the process of donating platelets. The blood product, containing T cells, is sent to the product manufacturer for 16 ASBMT CAR-T Letter to CMS September

27 Attachment 2, Page 19 of 28 stimulation and growth in the laboratory, followed by genetic modification through the introduction of the CAR transgene into the T cells. After additional expansion over days to weeks, the T cells are shipped back to the site of care and reinfused into the patient. In the patient, the cells proliferate, recognize their target antigen on tumor targets, and perform effector functions characteristic of native T cells, resulting in tumor death. 17 ASBMT CAR-T Letter to CMS September

28 Attachment 2, Page 20 of 28 The mechanism of action for KTE-C19 (CAR T) is distinctly different from BiTEs in the following ways: CAR T cells perform cell lysis on the targeted cancer cells. In contrast, BiTE technologies are antibodies designed to link a patient s T cells via CD3 to CD19 on their tumor cells. Following binding, the engaged T cells will react against the tumor. Without the BiTE present, the T cells do not recognize or destroy the target. Given the low molecular weight of BiTE, it must be continuously administered to have a therapeutic effect. BiTE therapies/technologies do not induce T cell co-stimulation, a foundational aspect of CAR T technologies. As BiTE is a small protein molecule with a short half-life, it must be continuously administered to have a therapeutic effect and therefore does not have the same potential for long-term anti-tumor effects as CAR T cells. CAR T cells may persist for many months or even years, and provide continuous surveillance, protecting against relapse of tumor. In addition, they have the ability to expand in response to antigenic stimulation and are self-amplifying. CAR T also have a different volume of distribution to BiTE therapies as they can traffic through multiple tissue planes and access tumor deposits that may not be accessible to BiTE therapies. BiTE requires continuous intravenous infusion in 28-day cycles, while CAR T cells are typically delivered in one or two infusions. BiTE does not have the mechanistic ability to persist in the body in a manner that could be independently curative. BiTE technology is dependent on the fitness of the endogenous T cell population and does not generate new cells. CAR T therapy, including the KTE-C19, involves genetic modification or engineering the T cells, which are expanded ex vivo, and also expand in vivo following administration. 18 ASBMT CAR-T Letter to CMS September

29 Attachment 2, Page 21 of 28 BiTE is not a personalized medicine product and is manufactured through typical biologic pharmaceutical processes. As CAR T therapy is an autologous cellular product, it currently requires harvest, transport and laboratory modification of a patient s own cells, requiring entirely distinct product custody processes. CAR T allows for ex vivo modulation of the patient s T cell population with respect to phenotype and CD4:CD8 ratios, while BiTE, as a non-cellular product, does not allow for customization. Assignment to Same MS-DRG: The Agency contends that KTE-C19 does not satisfy the MS- DRG assignment criterion because the patients who will utilize KTE-C19 map to the same MS- DRGs as those patients currently receiving non-kte-c19 therapies for the same diagnoses. CMS uses a MS-DRG mapping system based on a patient s diagnosis within the Major Diagnostic Categories (MDCs). Aside from Autologous HCT (MS-DRGs 016/017), which is a Pre-MDC MS-DRG with an assignment driven by the use of the ICD-10-PCS code, there are no MS-DRGs that recognize a combination of a lymphoma diagnosis and a non-o.r. cellular therapy procedures like the infusion of KTE-C19. As CMS does not have other Cellular Therapy Pre-MDC MS-DRGs, all patients who are hospitalized for the treatment of their primary lymphoma diagnosis will be placed into one of the MS-DRGs with MDC 17 Myeloproliferative Diseases & Disorders, Poorly Differentiated Neoplasms. Of the MS-DRGs within MDC 17, the applicant has correctly mapped potential KTE-C19 patient cases to all of the non-surgical/o.r. lymphoma-diagnosis MS-DRGs available. It is unreasonable to expect that the patient population expected to be candidates for KTE-C19 would map to different MS-DRGs if those potential MS-DRGs do not currently exist. Type of Disease and/or Patient Population: If FDA approved, KTE-C19 would be the first engineered autologous cellular immunotherapy indicated for the treatment of adult patients with relapsed/refractory aggressive B cell non-hodgkin lymphoma (NHL) who are ineligible for 19 ASBMT CAR-T Letter to CMS September

30 Attachment 2, Page 22 of 28 autologous stem cell transplant (ASCT). Blincyto is currently indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Aggressive B cell non-hodgkin lymphoma (NHL) is a distinct disease from ALL, with different genetic, pathologic, biochemical, epidemiologic, clinical, and therapeutic indicators. Although they are both derived from cells of the B cell lineage, and therefore both express CD19, they are very distinct diseases and require separate consideration as such. This would be the first and only FDA approved treatment for the relapsed/refractory aggressive B cell non-hodgkin lymphoma patient population. 20 ASBMT CAR-T Letter to CMS September

31 Attachment 2, Page 23 of 28 DRG Rate Inadequacy: The applicant provided an analysis that indicates that the vast majority of patient archetypes that would be potentially treated with KTE-C19 would be currently billed for MS-DRGs 840 (Lymphoma & Non-Acute Leukemia with MCC), 841 (Lymphoma and Non- Acute Leukemia with CC), 846 (Chemotherapy without Acute Leukemia as Secondary Diagnosis with MCC), and 847 (Chemotherapy without Acute Leukemia as Secondary Diagnosis with CC). The ASBMT does not have access to confidential information about pricing for KTE- C19 and other engineered T Cell Therapies, though public reports of anticipated price points for these therapies make it reasonable to expect product costs of more than $200,000 per patient. This product cost will be a true cost to the hospital providing the service, as the product s manufacturer is entirely separate from the healthcare organization. Additionally, there will be rare cases when a patient is not able to proceed with the infusion of the product due to death or other clinical complications. Of the potential MS-DRGs indicated by the applicant, MS-DRG 840 is at the highest relative weight. As noted earlier, MS-DRG 840 has a relative weight of and a base reimbursement of approximately $19,725. The lowest paying MS-DRG of the main potential MS-DRGs indicated by Kite Pharma is MS-DRG 847, with a RW of and an estimated corresponding reimbursement rate of $6,984. Separate from the cost of the product, the average length of stay for Medicare beneficiaries receiving KTE-C19 will likely deviate substantially from the range of ALOS numbers associated with MS-DRGs 840, 841, 846 and 847, which range from 4 to 11 days. As CMS notes, the applicant s supplied information about Study 1 indicated a median stay of 15 days. The subset of patients that develop one of known potential post-infusion complications, including Cytokine Release Syndrome (CRS) and/or treatment-associated neurotoxicity, will likely require hospitalization until symptoms fully resolve potentially for up to 2-3 weeks. Additionally, in the Zuma-1 KTE-C19 study, 43% of patients experienced complications severe enough to need infusions of high doses of Tocilizumab, an expensive immunosuppressive drug. Given the expected price for the hospital to acquire the product, in conjunction with expected increases in ALOS and additional interventions during the inpatient stay, indicate that current MS-DRG rates are wholly inadequate. 21 ASBMT CAR-T Letter to CMS September

32 Attachment 2, Page 24 of 28 Substantial Clinical Improvement: As CMS notes in the clinical summary, approximately 50% of newly diagnosed patients are successfully treated with CHOP/R-CHOP. For those patients with refractory or relapsed disease after first-line treatment, less than 50% of patients are eligible for second-line regimens and none of the current options will do more than temporarily halt progression of the disease. Medicare beneficiaries will be greatly impacted by the availability of this new technology, as the median age of diagnosis for non-hodgkin Lymphoma is 67 years of age (NCI SEER Data). In CMS s summary, the Agency notes that the study results submitted with the NTAP application had limitations in terms of numbers of individuals treated and post-treatment followup. Since the time of NTAP application submission and initial review (Q1 CY2017), additional study results have been publicly released and presented at clinical meetings. The primary analysis results of the pivotal Zuma-1 clinical trial evaluating KTE-C19 in patients with chemorefractory aggressive B cell lymphomas (DLBCL, PMBCL, and TFL) was presented at the American Association for Cancer Research Annual Meeting on April 2, Patients enrolled and treated on Zuma-1 had truly chemo-refractory disease defined as at best stable disease (no significant radiographic decrease in size of lymphoma tumors per standard criteria) to their last line of chemotherapy or who had relapsed within 12 months of an autologous hematopoietic stem cell transplant. Of the 101 patients that had received KTE-C19 at the time of the data cutoff, the median follow-up was 8.7 months. Zuma-1 met the primary endpoint of improved Objective Response Rate (ORR) (p<0.0001) compared to historical control. The ORR was 82% and the Complete Response (CR) rate was 54% for treated patients, with 44% of patients remaining in response at the time of the data cutoff. These results compare favorably to outcomes with existing standard therapies evaluated in the SCHOLAR-1 study, an international 9 Locke FL, Neelapu N, Bartlett NL, Lekakis LJ, Miklos D, Jacobson CA, Braunschweig I, Oluwole O, Siddiqi T, Lin Y, Timmerman J, Friedberg JW, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Wiezorek J, Go WY. Clinical Trials Plenary Session, Oral Presentation Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE C-19) in patients with refractory aggressive non-hodgkin lymphoma. Clinical Trial Plenary Session. American Association for Cancer Research Annual Meeting /04/02: Abstract CT ASBMT CAR-T Letter to CMS September

33 Attachment 2, Page 25 of 28 meta-analysis of more than 600 patients in an analogous refractory patient population. 10 ORR was 82% in Zuma-1 compared to 26% in SCHOLAR-1; the CR rate was 54% in Zuma-1 compared to 8% in SCHOLAR-1; and the 6-month Overall Survival by Kaplan-Meier method was 80% in Zuma-1 compared to 55% in SCHOLAR-1. Importantly the median duration of response for patients achieving CR with KTE-C19 has not yet been reached. With 8.7 months of follow-up the lower bound of the 95% confidence interval for median overall survival is 10.5 months, and likely to be much longer, again comparing favorably to the SCHOLAR-1 with a median overall survival of 6.6 months. Three of the seven lymphoma patients treated with the same CAR T cell construct on the phase 1 trial of KTE-C19 remain in remission over 1 year after therapy 11 and patients treated at the National Cancer Institute remain in remission over 2 years after therapy. 12 These results clearly illustrate that KTE-C19 CAR T cell therapy is an improvement over existing standard of care therapies. KTE-C19 also compares favorably to efficacy of BiTE antibody therapy for aggressive B cell NHL. Although the ORR to BiTE was 43% in a phase 2 trial of aggressive B cell lymphomas, it included patients with less aggressive disease than evaluated in Zuma-1 and SCHOLAR-1. For patients with truly chemo-refractory lymphoma treated with a CD19 BiTE, the ORR was a dismal 19%, which is not even close to the 82% ORR seen with KTE-C19 in this population and is similar to the 26% ORR seen with standard chemotherapies presented in SCHOLAR Crump, M., Neelapu, S.S., Farooq, U., Van Den Neste, E., Kuruvilla, J., Ahmed, M.A., Link, B.K., Hay, A.E., Cerhan, J.R., Zhu, L. et al. Outcomes in refractory aggressive diffuse large B-cell lymphoma (DLBCL): results from the international SCHOLAR-1 study. J. Clin. Oncol. 2016; Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of DTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther 2017 Jan; 25: (1) PMID: , PMCD: PMC Brudno JN, Somerville RP, Shi V, Rose JJ, Halverson DC, Fowler DH, Gea-Banacloche JC, Pavletic SZ, Hickstein DD, Lu TL, Feldman SA, Iwamoto AT, Kurlander R, Maric I, Goy A, Hansen BG, Wilder JS, Blacklock-Schuver B, Hakim FT, Rosenberg SA, Gress RE, Kochenderfer JN. Allogeneic T Cells That Express an Anti-CD19 Chimeric Antigen Receptor Induce Remissions of B-Cell Malignancies That Progress After Allogeneic Hematopoietic Stem-Cell Transplantation Without Causing Graft-Versus-Host Disease. J Clin Oncol Apr 1;34(10): doi: /JCO Epub 2016 Jan Viardot A, Goebeler ME, Hess G, Neumann S, Pfreundschuh M, Adrian N, Zettl F, Libicher M, Sayehli C, Stieglmaier J, Zhang A, Nagorsen D, Bargou RC. Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in 23 ASBMT CAR-T Letter to CMS September

34 Attachment 2, Page 26 of 28 In the FY2002 IPPS Final Rule, CMS states that a new technology represents substantial clinical improvement when it reduces mortality, decreases the number of hospitalizations or physician visits or reduces recovery time compared to the technologies previously available (66 FR 46902). As the previous comments outline, the reductions in mortality for relapsed/refractory patients being treated with KTE-C19 are pronounced. And while an extended study of comparative health care utilization is not yet available, KTE-C19 s ability to create partial and complete remissions in a patient population will likely reduce otherwise ongoing outpatient and inpatient visits and admission for chemotherapy and chemotherapy-induced complications. CAR T therapy in general, and KTE-C19 specifically, should not be viewed as a better hammer, but an entirely new tool for a group of patients that do not have another option that would potentially induce remission. Palliation-intended chemotherapy regimens are the only realistic alternative treatment for the indicated population of relapsed/refractory individuals. The achievement of partial and complete remissions in these relapsed/refractory patients is not feasible with any other currently available therapy and is therefore extremely clinically remarkable. The ASBMT Committee on Cellular Therapy, comprised of leading experts in cellular therapies including hematopoietic transplantation, welcomes any further questions CMS staff may have on the technology, its intended uses and its clinically differentiating features. II. Future Processing of Claims for Engineered T Cell Therapies The ICD-10 Coordination & Maintenance Committee (C&M) recently approved ICD-10-PCS New Technology Codes XW033C3/XW043C3 New Technology, Introduction, Engineered Autologous Chimeric Antigen Receptor T Cell Immunotherapy. As additional engineered T Cell therapies are developed and approved, we ask that CMS develop a comprehensive reimbursement structure for these therapies. As outlined elsewhere in this letter, these technologies are entirely new and will have costs and resource needs that are significantly relapsed/refractory diffuse large B-cell lymphoma. Blood Mar 17;127(11): doi: /blood Epub 2016 Jan ASBMT CAR-T Letter to CMS September

35 Attachment 2, Page 27 of 28 different from either chemotherapy-oriented disease-specific MS-DRGs or from current cellular therapies like Autologous and Allogeneic HCT. CMS should plan to create separate MS-DRGs for CAR T and other engineered T Cell therapies to ensure that the costs associated with the provision of these therapies does not impede access for Medicare beneficiaries. Use of the newly approved ICD-10-PCS code for CAR T, in combination with the product-specific J/Q indicator and National Drug Code will allow CMS and other Health Services Researchers to understand the resource utilization and cost-efficacy associated with these technologies. While the first generation of CAR T therapies are autologous products, products currently in development include both individually-matched allogeneic and universal donor sourced cells. Requiring use of a code to indicate cell source and creating a specific table outside of the New Technology setting, similar to the Table 302 (Transfusion), dedicated to engineered T Cell therapies, will allow CMS and other stakeholders to capture the full detail on the variations in products as these technologies evolve. III. Facilities Appropriate for Implementation of Engineered T Cell Therapies As discussed throughout this comment letter, the anticipated introduction of FDA-approved engineered T Cell Therapies will create a sea change within the practice of oncology for patients with the indicated diagnoses. While appearing to be very effective clinically, the processes required to successfully treat patients with CAR T Cell therapies are not trivial they require sophisticated apheresis and cell laboratory capabilities, specialized training of all individuals involved with patient care, and multidisciplinary teams and care settings capable of quickly identifying and resolving post-infusion complications like CRS and treatment-associated neurotoxicity. HCT is similar in this regard, as the specialization needed to safely and effectively deliver it has resulted in centralized expert care teams within a limited number of hospitals/health care centers in the United States. Due to the need of payers and clinicians to be able to identify the clinical centers capable of performing this type of care, the Foundation for the Accreditation of Cellular Therapy (FACT) was founded as a joint effort between the ASBMT and the International Society for Cellular Therapy (ISCT) in An independent organization 25 ASBMT CAR-T Letter to CMS September

36 Attachment 2, Page 28 of 28 within the University of Nebraska, FACT has become the recognized leader in international standards and peer-accreditation for HCT programs. Due to the need for similar processes and structures for the delivery of the anticipated Engineered T Cell therapies, FACT has issued inaugural editions of Standards for Immune Effector Cells and an Accreditation Manual for programs hoping to provide these new therapies to their patients. We encourage the Agency to begin dialogue with FACT to better understand the need for these therapies to be delivered in facilities that have been vetted for their capabilities to safely and comprehensively care for patients receiving Engineered T Cell therapies. 26 ASBMT CAR-T Letter to CMS September

37 Attachment 3, Page 1 of 8 FOR DISCUSSION PURPOSESS ONLY Priority (Type) of Admission or Visit This attachment contains: Form Locator 14 from the 2018 UB 04 Manual (Pages 2 3) Correspondence between the NUBC secretary and the requestor (Nebraska Medicine) (Page 4) The original full request from Nebraska Medicine (Pages 5 7) New Draft FAQs for FL14 unrelated to the request (Page 8) 37

38 National Uniform Billing Committee Official UB-04 Data Specifications Manual 2018 Attachment 3, Page 2 of 8 FOR DISCUSSION PURPOSESS ONLY Effective Date: July1, 2007 Meeting Date: Form Locator 14 Page 1 of 2 Data Element Priority (Type) of Admission or Visit Definition: A code indicating the priority of this admission/visit. Reporting Field Attributes UB-04: Required : Required (per ASC X12N/005010X223A2). 1 Field 1 Line 1 Position Alphanumeric Left-justified Notes See codes and FAQ below Code Definition 1 Emergency The patient requires immediate medical intervention as a result of severe, life threatening or potentially disabling conditions. 2 Urgent The patient requires immediate attention for the care and treatment of a physical or mental disorder. 3 Elective The patient s condition permits adequate time to schedule the services. 4 Newborn Use of this code necessitates the use of special Point of Origin Codes (See Form Locator 15 page 7 of 7). 5 Trauma Visit to a trauma center/hospital as licensed or designated by the state or local government authority authorized to do so, or as verified by the American College of Surgeons and involving a trauma activation. (Use Revenue Code 068x to capture trauma activation charges involving prehospital notification.) 6-8 Reserved for assignment by NUBC. 9 Information not Available Information not available. AHA 2017 Single User License (Expires 6/30/18) Please do not copy or distribute Version July

39 National Uniform Billing Committee Official UB-04 Data Specifications Manual 2018 Attachment 3, Page 3 of 8 FOR DISCUSSION PURPOSESS ONLY Effective Date: July 1, 2017 Meeting Date: 3/14/17 Form Locator 14 Page 2 of 2 Data Element Priority (Type) of Admission or Visit FAQ FAQ # Question/Answer 1 Q: What is the appropriate code for a woman admitted for a scheduled cesarean? A: If the visit or admission is not emergent or urgent, Type of Admission code 3 - Elective would generally be appropriate. 2 Q: What is the appropriate code for a woman coming from her doctor s office admitted for an unscheduled cesarean? A: The Type of Admission depends on the circumstances. Either 1 - Emergency or 2 - Urgent may be appropriate. 3 Q: What is the appropriate code for a woman that presents while in labor? A: Women commonly present while in labor. There are various stages of labor. The Type of Admission would depend on the stage of labor and other circumstances. 1 - Emergency and 2 - Urgent may be appropriate. 4 Q: For a woman that presents while in labor, does pre-registration at the facility count as 3 - Elective instead of 1 or 2? A: Pre-registration is an administrative task where DOB, insurance coverage, current medications, etc. are collected. A range of expected delivery dates may also be included. The type of admission still depends on the circumstances upon presentation. Pre-registration does not imply the patient s condition permits adequate time to schedule the services. AHA 2017 Single User License (Expires 6/30/18) Please do not copy or distribute Version July

40 Attachment 3, Page 4 of 8 FOR DISCUSSION PURPOSESS ONLY Priority (Type) of Admission or Visit From: Omundson, Todd [mailto:tomundson@aha.org] To: Danielson, Jana L <JDanielson@nebraskamed.com> Subject: RE: NUBC Inquiry Request for Review of Priority Type of Admission and Visit Definitions.pdf Jana: The NUBC will entertain your request. The definitions you cite are from the UB Editor, which is published by Optum and not an official source. The Official UB 04 Data Specifications Manual published by the AHA ( UB 04 Manual ) is the official reference and incorporated in the HIPAA transaction standards. The UB 04 Manual does not contain a glossary. Judgment always plays a key role is assigning the appropriate code. The UB 04 Manual does not incorporate time or severity in the definitions. Very few questions have arisen in the past in terms of the definitions in FL14. We had one question earlier this year about the difference between urgent and elective with an example. But, based on the UB definitions and the situation, elective was clearly the applicable code. I have attached the current version of Form Locator 14. The definitions are concise. The FAQs are new for 2018, but we always consider questions, clarifications and enhancements for future editions (the 2019 edition will be published 7/1/18). Your request will be presented to NUBC at its next in person meeting April in Baltimore. Todd Omundson Secretary, National Uniform Billing Committee From: Danielson, Jana L [mailto:jdanielson@nebraskamed.com] To: Omundson, Todd <tomundson@aha.org> Subject: NUBC Inquiry Request for Review of Priority Type of Admission and Visit Definitions.pdf Thank you for entertaining our request. You are correct I should have compared and utilized the Official UB 04 manual in my request. The question essentially remains the same. Elective in the official UB 04 manual defines elective as The patient s condition permits adequate time to schedule the services. Urgent and emergent use the word immediate attention. We are following the concise definition but it has become clear that not everyone is. For all scheduled procedures we have deemed them to be elective and not immediate. We are in need of confirmation that judgement can play a role and that urgent and emergent can be used if immediate attention is not necessary and a procedure has adequate time for scheduling purposes. Jana Danielson, MS, FHFMA Executive Director Nebraska Medicine Revenue Cycle 40

41 Attachment 3, Page 5 of 8 FOR DISCUSSION PURPOSESS ONLY 41

42 Attachment 3, Page 6 of 8 FOR DISCUSSION PURPOSESS ONLY 42

43 Attachment 3, Page 7 of 8 FOR DISCUSSION PURPOSESS ONLY 43

44 Attachment 3, Page 8 of 8 FOR DISCUSSION PURPOSESS ONLY Priority (Type) of Admission or Visit New Draft FAQ Q1: A patient comes in to have a scheduled outpatient surgery. The patient then goes to Observation because of a complication. The complication becomes more defined and now the patient has to be urgently admitted as an inpatient for treatment. What would the admit type for the inpatient admission be? I understand that there should not be an admit type for the outpatient or observation admission according to this transmittal. A1: Priority (Type) of Admission or Visit is required on all claims. Admission signifies inpatient, while visit denotes outpatient. A scheduled outpatient surgery would normally be deemed an elective visit. The FL 14 evaluation is made at the time the patient presents to the hospital. Changing circumstances during the episode have no effect on the type of admission/visit code. The observation came after the surgery. The diagnosis codes on the claim indicate whether a condition was or was not present on admission (POA) and would account for complications subsequent to admission. The 8th character in the diagnosis field is the POA Indicator. Q2: Could you provide some guidance on the definitions for Urgent vs. Elective. We have had situations where the patient was admitted for a scheduled surgery, but the surgery scheduled is for a severe issue, i.e. Aortic or Mitral Valve Replacement. For example, we have a patient who was admitted for a Mitral Valve Replacement and possibly a CABG. The patient was initially consulted for the condition on 8/31/2017 and then underwent a coronary angiogram on 10/10/2017 to evaluate the status of her coronary artery disease. She has severe mitral valve prolapse which is symptomatic and was admitted on 11/14/17 for the surgery (scheduled in October). Would this be considered elective or urgent? We are wondering if certain cardiac (or even other) surgeries should be classified as urgent, even though the procedure is scheduled. These are often scheduled with a sense of urgency. I think it would help if we had more context around what immediate means and for elective the patient s condition permits adequate time to schedule services. Are there any FAQs or additional examples you could give us? A2: Judgment always plays a key role. The UB definitions don t address or take into account severity. Based on the UB definitions, Urgent requires immediate attention. Elective is appropriate if there is adequate time to schedule the services. In this scenario, it appears that there was adequate time (over a month) to schedule the surgery. 44

45 Attachment 4, Page 1 of 2 Rehabilitation Codes The Maine Health Data Organization has brought up an issue regarding Rehabilitation Codes that were impacted by the switch to ICD 10 CM. It appears that this coding issue began with the introduction of ICD 10s in the 4th Quarter of Before this time (under ICD 9s), coders were instructed to use a V code for any inpatient rehabilitation patient discharge. This concept was not carried forward with the introduction of ICD 10 CM. Beginning in the 4th Quarter of 2015 and for all of 2016 data, these patients are not always being properly grouped into DRGs 945 and 946; instead, they appear they are being grouped into other DRGs. Listed below are a few of those DRGs. This has the effect of over populating the total number of discharges within these DRGs. 057 Degenerative nervous system disorders w/o MCC 981 Extensive O.R. procedure unrelated to principal diagnosis w MCC 988 Non extensive O.R. proc unrelated to principal diagnosis w CC 559 Aftercare, musculoskeletal system & connective tissue w MCC 560 Aftercare, musculoskeletal system & connective tissue w CC 561 Aftercare, musculoskeletal system & connective tissue w/o CC/MCC 949 Aftercare w CC/MCC 267 Endovascular cardiac valve replacement w/o MCC Background As noted above, the GROUPER logic does not classify the rehab cases in the same way under ICD 10 CM as it did in ICD 9 CM because of changes in the codes and guidelines. Under the current DRG logic, cases are assigned to an MS DRG within the Major Diagnostic Categories (MDC) where the principal diagnosis code is found. For example, a patient receiving rehab to address the neurological deficits from a stroke will be grouped to a stroke DRG in the nervous system MDC, rather than to the rehab DRGs. CMS s analysis for the FY 2018 IPPS proposed rule indicated there was a significant decrease in the number of cases and a change in the average length of stay for DRGs 945 and 946 when compared to the prior year when claims were submitted with ICD 9 CM codes. CMS also examined possible MS DRGs where these cases may have been assigned in FY 2016 based on increases in the number of claims. CMS was unable to determine if these were cases admitted for rehabilitation that moved from MS DRGs 945 and 946, or if there was simply a change in the number of cases. CMS said they were unable to update MS DRGs 945 or 946 to better identify those cases in which patients are admitted for rehabilitation services because there was not a specific diagnosis code. CMS also indicated that if the CDC (the federal agency responsible for the creation and maintenance of the ICD 10 CM code set) creates a new ICD 10 CM code for an encounter for rehabilitation services, they would consider proposing updates to MS DRG 945 and 946 utilizing these new codes in future rulemaking. In March 2017, AHA asked for input on whether this was still a problem for hospitals. A couple of states had mentioned that they had workarounds developed for public aid, Workers' compensation and other payers. North Carolina and Virginia were examples of states that had developed a workaround, but it was labor intensive and not ideal. Indiana and Minnesota also considered this a significant problem. 45

46 Attachment 4, Page 2 of 2 The AHA submitted a proposal to the CDC to create a single new ICD 10 CM diagnosis code ( Z code ) to replicate the ICD 9 CM code category V57 Care involving use of rehabilitation procedures. The proposal was heard at the March 7 8, 2017 meeting of the ICD 10 Coordination and Maintenance Committee. The CDC felt that the code violated ICD 10 principles that exclude procedural information in diagnosis codes and hence no new diagnosis code has been created. Question Are there other codes within the inpatient data set that might help identify Inpatient rehabilitation patients? For example, revenue codes: 042x Physical Therapy, 043x Occupational Therapy, 044x Speech Therapy Language Pathology (Note: A number of states, however, do not collect revenue codes and would need to change legislation in order to do so.) Other possibilities for states in terms of identification of these patients. 1. Type of Bill code 2. Form Locator 15 Point of Origin Code D. Transfer from one distinct unit within a hospital to another distinct unit resulting in a separate claim to the payer. (Examples could include: observation services, psychiatric services, rehabilitation units, Swing bed located in an acute hospital.) (Question: Does this require a physical shift from one unit to another? Or, can the patient stay in the same bed, but be treated by a rehab staff person from the rehab unit?) 3. Form Locator 17 Patient Discharge Status Code 90. Discharged/transferred to an Inpatient Rehabilitation Facility (IRF) including Rehabilitation Distinct Part Units of a Hospital with a Planned Acute Care Hospital Inpatient Readmission. FAQ 49 (see Q & A re Code 82 vs. Code 02). Report Code 02 Discharged/Transferred to a Short Term General Hospital for Inpatient Care is appropriate for transfers from rehabilitation hospitals; includes distinct part unit transfers to the same or another acute care hospital. 4. Form Locators Value Codes. Reporting PT, OT, SP, Cardiac Rehab Visits (Codes 50 53) provided from the onset of treatment from the billing provider through this billing period. 46

47 JM1_Summary of AUC for Diagnositc Imagining Page 1 of 3 03/2018 Appropriate Use Criteria for Advanced Diagnostic Imaging Services High Level Overview The Centers for Medicare & Medicaid Services (CMS) is establishing a requirement that physicians consult appropriate use criteria (AUC) for advanced diagnostic imaging services prior to the ordering of those services. The AUC use evidence based guidelines to identify if an imaging service is medically beneficial for the patient s condition. The goal of AUC is to decrease the over utilization of medically unnecessary imaging services. Once the AUC is implemented, the ordering physician will be required to consult a clinical decision support mechanism (CDSM) prior to ordering an advanced diagnostic imaging service. The CDSM will inform the ordering physician if the service is appropriate, not appropriate, or not applicable. The furnishing professional and facility will be required to report certain AUC data on the claim for the service in order to be reimbursed for the service. CMS is still working on the format of the data that will need to be reported on the claim. A recent proposal to develop HCPCS G codes and modifiers has been abandoned and CMS is now looking at creating a unique consultation identifier. The initial legislative deadline for reporting the AUC data was January 1, This deadline has been delayed in subsequent regulation and is currently set at January 1, Additional Detail The Protecting Access to Medicare Act of 2014 (PAMA) directed CMS to establish a program to promote the use of AUC for advanced diagnostic imaging services. The requirements for AUC have been further identified in the Physician Fee Schedule (PFS) Final Rules for 2016, 2017, and Additional regulations are expected to continue to further define the requirements. The intent of the AUC is to present information in a manner that links a specific clinical condition or presentation; one or more services; and an assessment of the appropriateness of the service(s). The AUC is based on evidence based guidelines for particular clinical scenarios and presenting symptoms or condition. It is to assist physicians in selecting the imaging service that is most likely to improve health outcomes for patients based on their individual clinical presentation. The four major components of the AUC program are: 1. Establishment of AUC 2. Identification of mechanisms for consultation with AUC 3. AUC consultation by the ordering physician and reporting by the furnishing professional; and 4. Annual identification of outlier ordering physicians for services furnished. 47

48 JM1_Summary of AUC for Diagnositc Imagining Page 2 of 3 03/2018 Establishment of AUC The 2016 PFS final rule established the requirements for the development of evidence based AUC. It defined provider led entities (PLEs) and established the process through which PLEs may become qualified to develop AUC. The term PLE was defined to include national professional medical societies, health systems, hospitals, clinical practices, and collaborations. The first list of qualified PLEs was posted to the CMS website in June The PLEs are the organizations that identify the AUC for the specific advanced diagnostic imaging based on the medical condition. Mechanism for AUC Consultation The 2017 PFS final rule identified the mechanism for AUC consultation, called CDSMs. It established the requirements and qualification process for CDSMs. The CDSM is an interactive, electronic tool through which the physician consults the AUC when ordering an imaging test to determine if it is appropriate, per evidence based guidelines, for the patient. The CDSMs can be stand alone or integrated into an electronic health record (EHR). The first list of qualified CDSMs was posted to the CMS website in July The following priority clinical areas were named in the 2017 PFS final rule. CMS has the ability to add additional priority clinical areas in the future. Coronary artery disease (suspected or diagnosed) Suspected pulmonary embolism Headache (traumatic and non traumatic) Hip pain Low back pain Shoulder pain (to include suspected rotator cuff injury) Cancer of the lung (primary or metastatic, suspected or diagnosed) Cervical or neck pain CMS estimates that the current list of priority clinical areas represents about 40 percent of advanced diagnostic imaging services paid for by Medicare, as of AUC Consultation and Reporting This component of the program is the consultation of the AUC through a CDSM by the ordering physician and the reporting of the AUC data on the claim by the furnishing professional and facility. Ordering physicians will be required to consult a CDSM for every advanced diagnostic imaging service ordered. If there is no applicable AUC in the CDSM for the service, it will return a response of not applicable. The CDMS must make available, at a minimum, AUC that reasonably addresses common and important clinical scenarios within all priority clinical areas. 48

49 JM1_Summary of AUC for Diagnositc Imagining Page 3 of 3 03/2018 Exceptions to consulting AUC have been established for emergencies, inpatient imaging services, and ordering physicians who meet the hardship exception in the Medicare EHR Incentive Program. The data to be reported on the claim are: The CDSM consulted by the ordering physician; Whether the service adhered to the applicable AUC, did not adhere to the applicable AUC, or whether no criteria in the CDSM were applicable to the patient s clinical scenario; and The name and national provider identifier (NPI) of the ordering physician. This data is expected to be reported on the furnishing professionals claim for the professional component and the facility claim for the technical component of the service. The 2018 PFS proposed rule proposed a process for reporting the AUC data on the claim using a series of HCPCS level 3 G codes for the specific CDMS used and a series of modifiers for the CDSM response or presence of an exception. CMS received numerous comments that the use of G codes and modifiers would be an excessive burden to physicians and other practitioners. Many commenters suggested CMS create a unique consultation identifier as an alternative. In response to the comments, CMS stated it would not pursue the G code option and would instead look into the use of a unique consultation identifier. CMS indicated it would conduct outreach with stakeholders in 2018 and discuss changes in future rulemaking. Initially the deadline for reporting the AUC data on the claim was January 1, This date has been subsequently delayed in each PFS final rule. As of the 2018 PFS final rule, the implementation date is set for January 1, CMS intends for the first year to be an educational and operations testing period during which claims will not be denied if the AUC data reported on the claim are not accurate. The 2018 PFS final rule establishes a voluntary reporting period from July 2018 through December 2019, which is completely optional for participation. CMS intends to create HCPCS modifier that will indicate only that a CDSM was consulted and it can be reported by the furnishing professional and facility at the line level with the CPT code for the service. This limited reporting is expected to be temporary. Identification of Outliers The final component of the AUC program is to identify outlier ordering physicians. Physicians who are deemed to be outliers of the AUC will be required to complete prior authorizations for imaging services. With the delay in reporting requirements, the evaluation of outliers has been postponed. Further information is expected in the 2019 PFS proposed rule. 49

50 JM2_AUC WorkFlow Scenarios Page 2 of 5 Permission received from AHRA to use diagram 50

51 JM2_AUC WorkFlow Scenarios Page 3 of 5 Permission received from AHRA to use diagram 51

52 JM2_AUC WorkFlow Scenarios Page 4 of 5 Permission received from AHRA to use diagram 52

53 JM2_AUC WorkFlow Scenarios Page 5 of 5 Permission received from AHRA to use diagram 53