August 2018: Policy Perspectives

By Kate Jacobson posted 08-02-2018 01:14 PM

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By Stephanie Farnia, ASBMT Director of Health Policy and Strategic Relations

As you know from previous columns, there seems to be an ever-expanding set of health policy issues for ASBMT members to understand. Given that demand, I’m very happy to have Joe Nahra, a member of the ASBMT team in Washington, D.C., helping to monitor and summarize key issues. Joe graduated from the University of Pennsylvania with a focus in public policy; he tracks issues of interest specific to healthcare for associations.

2019 Medicare Inpatient Prospective Payment System Final Rule Released

On August 6, CMS released its final rule updating the Medicare Inpatient Prospective Payment System (IPPS) for 2019.

Navigating the Rule:

The main file is titled “CMS-1694-F” and is just over 2,500 pages long. It can be viewed on the CMS website or in the Federal Register notice.
The proposals included in the rule are final. The proposed update to the IPPS was released in April and CMS accepted comments (including those from ASBMT) until June 25. The provisions in this rule will apply to services provided after the effective date of October 1, 2018.

Key Provisions:

Unfortunately, the finalization of the CAR-T payment in the final rule did not include suggested changes from ASBMT. Our proposed changes would have allowed for providers to recover more of their costs associated with drug acquisition and the provision of inpatient care. CMS finalized assignment of CAR-T to the newly renamed MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy) without making changes to the way that the CAR-T drug costs are reimbursed or calculated for the purposes of outlier payment. The base payment rate for MS-DRG 016 for FY2019 is approximately $36,000. We will address in more detail the final rule and the administration’s reasoning for the decision in our town hall, linked above.

ASBMT TOWN HALL: August 29, 12 p.m. to 1 p.m. CT

Join Stephanie Farnia and Jugna Shah (Nimitt Consulting) for a catch-up on a number of reimbursement policy issues, including:

Final IPPS Rule debrief
Planned ASBMT comments on PFS and OPPS
CMS CAR-T MEDCAC summary
CAR-T Coding updates

Sign up here

2019 Physician Fee Schedule and Quality Payment Rule Proposals Released

On July 12, the Centers for Medicare and Medicaid Services (CMS) released its 2019 proposal for updates to the Medicare Physician Fee Schedule, which also integrated proposed changes to the Quality Payment Program.

Navigating the Rule:

The main file is titled “CMS-1693-P” and is just under 1,500 pages long. It can be viewed on the CMS website or in the Federal Register notice.
The proposals included in the rule are not final. Comments are being accepted until Sept. 5, 2018. After that date, CMS will review all submitted comments and work toward releasing a final rule in late November. The provisions in the final rule will only apply to services provided after the effective date of Jan. 1, 2019. Comments can be submitted electronically at www.regulations.gov (search for CMS-1693-P) or go directly to the rule page.

Key Provisions: There are three portions of the proposals worth discussing in some detail.

Evaluation & Management changes: CMS is considering significant modifications to the codes billed for office visits – Evaluation & Management (E/M) codes - for CY2019. While there are a few complicating details, the general concept is reducing five levels of E/M coding (all with different levels of RVUs/payments assigned) to two, in conjunction with a reduction in the documentation required to bill these visits. CMS has predicted minor (-1 to 2 percent) variance in total compensation associated with these visits from the current state for hematology/oncology physicians, but several physician societies have expressed concern about the quality of CMS’s data and analysis. ASBMT is participating in efforts being led by the American College of Physicians, the American Medical Association and several physician society coalitions to better understand the likely impact, and will share recommended language for comments when it is finalized.
Telehealth: CMS is proposing separate payment for a broader range of telehealth services than in the past, including the following codes:

Brief Communication Technology-based Service, e.g. Virtual Check-in (HCPCS code GVCI1)
Remote Evaluation of Recorded Video and/or Images Submitted by the Patient (HCPCS code GRAS1)
Chronic Care Remote Physiologic Monitoring (CPT codes 990X0, 990X1, and 994X9)
Interprofessional Internet Consultation (CPT codes 994X6, 994X0, 99446, 99447, 99448, and 99449).

CMS notes that “Practitioners could be separately paid for the Brief Communication Technology-based Service when they check in with beneficiaries via telephone or other telecommunications device to decide whether an office visit or other service is needed. This would increase efficiency for practitioners and convenience for beneficiaries. Similarly, the Remote Evaluation of Recorded Video and/or Images Submitted by the Patient would allow practitioners to be separately paid for reviewing patient-transmitted photo or video information conducted via pre-recorded “store and forward” video or image technology to assess whether a visit is needed.”

While these codes have relatively low proposed RVU values associated with them, this type of work has been frequently flagged by ASBMT as a significant body of unpaid work and any payment associated with it will likely be welcome. We expect that these proposals will be finalized in the final rule and will provide an update at that time.

Modifications to the QPP Low Volume Threshold: The first two years of the QPP program included a set of parameters for determining which providers would be required to participate in the full program. A useful summary of the full scope of changes can be found in a CMS posting on the topic; in short, the CY 2019 eligibility criteria are being proposed as the following:
1. Dollar Amount ($90,000)
2. Number of Beneficiaries (200)
3. Number of Covered Professional Services (200)

A useful summary of the changes to the QPP can be found in a CMS posting on the topic.

2019 Outpatient Prospective Payment System & Ambulatory Surgical Center Proposals Released

On July 25^th, the CMS released its proposed rule for updates to the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System. This is the payment system that pays for Part B services, including outpatient HCT.

Navigating the Rule:

The main file is titled “CMS-1695-P” and is approximately 750 pages long. It can be viewed on the CMS website or in the Federal Register notice.
As with the PFS/QPP rule, these proposals are not final. Comments are being accepted until Sept. 24, 2018. After that date, CMS will review all (yes, all) submitted comments and work toward releasing a final rule in late November. The provisions in the final rule will apply to services performed in ASCs or outpatient departments during the 2019 calendar year. Comments can be submitted electronically at www.regulations.gov (search for CMS-1695-P) or go directly to the rule page.

Key Provisions:

The rule has several proposals that we are still analyzing. We will plan to share a more comprehensive update during the August town hall, as well as through an additional written communication.

AMA Issues Category III CPT codes for CAR-T Services

As reported earlier, Dr. EJ Shpall represented ASBMT in a collaborative request along with ASH, ASCO and the College of American Pathologists seeking a series of new codes specific to CAR-T clinical services. The American Medical Association maintains the CPT coding set and has very specific requirements for when new technologies can qualify for certain types of codes. Due to the limited volume of experience so far, CAR-T associated services were assigned Category III codes.

Detail of the codes can be read on this AMA resource.

These codes will replace the previous coding recommendations on our CAR-T coding grid when they go into effect on Jan. 1, 2019. Payers, particularly the Medicare contractors, have various perspectives on payment for Category III codes and there will be some necessary work on all of our parts to provide the information needed to set payment on track. We anticipate revising the codes into Category I codes after a few years of data reporting; it will be critical for members to report these codes and the corresponding charges consistently in the interim. We will be discussing this issue more during the August 29 town hall.

ASBMT Issues Letter to CMS for New ICD-10 Code

On July 13, ASBMT delivered a letter to CMS requesting the addition of a new ICD-10-PCS code to identify stem cell transplants utilizing T-cell depleted grafts. Due to the increased use of alternative donors and related increases in GVHD risks, T-cell depleted grafts may be used more frequently and need to be accurately reflected in clinical reporting. A new code would allow for differentiation in the reporting between the types of grafts, as the current codes only provide options for bone marrow, peripheral blood stem cells, and cord blood. You can read the full letter here, and the request will be reviewed at the September 2018 meeting of the ICD-10 Coordination and Maintenance Committee.

CMMI Ends Plans for Kymriah Payment Model

According to a recent Politico report, the Center for Medicare and Medicaid Innovation has abandoned plans for a new payment demonstration for Novartis’ Kymriah therapy. CMS had announced its intentions to create an outcome-based payment system for the drug immediately following the FDA’s approval of the gene therapy in August 2017.

This announcement does not impact the availability of Kymriah or the participation of individual treatment centers in Novartis’ outcomes-based payment program, which is only available for the pediatric B-ALL indication.

NIH and Veterans Administration Announce New Cancer Trial Program

The National Cancer Institute, along with the Department of Veterans Affairs, announced the creation of a new agreement to expand veteran access to clinical trials of novel cancer treatments. The NCI and VA Interagency Group to Accelerate Trials Enrollment, or NAVIGATE, is launching at 12 VA facilities nationwide and will provide infrastructure and funding to VA facilities to participate in NCI-sponsored trials. The VA will also work to establish a network focusing on NCI trial goals through its national healthcare system, the Veterans Health Administration. The program will be jointly managed for three years with the expectation of long-term development to handle trials, which will include experimental treatments such as precision medicine and immunotherapies. To learn more about the NAVIGATE program, visit the NIH website.

Sickle Cell Disease Sign-On Letter

In February, ASBMT joined a coalition supporting the introduction of S. 2465, the Sickle Cell Disease Research, Surveillance, and Treatment Act of 2018. The proposed bipartisan legislation would authorize a national program to improve data collection on impacted patients in states with the highest prevalence of sickle cell disease (SCD). ASBMT has joined with the American Society of Hematology and other organizations to present a letter to Sens. Lamar Alexander and Patty Murray, the chairman and ranking member of the Senate Health, Education, Labor, and Pensions (HELP) committee, reiterating support for the legislation and asking that it be advanced this year. On July 25, the committee unanimously approved the bill and advanced it to the full Senate. ASBMT will continue to work with our coalition to monitor progress of the legislation and push for its approval and reconciliation with similar legislation that passed the House earlier this year.

CMS MEDCAC Meeting on PROs for CAR-T

In April, CMS opened a National Coverage Analysis for CAR-T. As part of this year-long process, CMS is convening a MEDCAC meeting on August 22. The focus of the meeting is on Patient Reported Outcomes (PROs) for CAR-T. Earlier this month, ASBMT assembled a small group of experts and drafted a response to CMS in advance of the meeting. Several members of that group have been selected to represent ASBMT members and present at the MEDCAC meeting next month. A live stream of the August 22 meeting will be available; see the Federal Register notice for details on registration and streaming.

Congratulations to the following selected speakers:

Kathryn Flynn (Medical College of Wisconsin)
Surbhi Sidana (Mayo)
Heather Jim (Moffitt)
Gunjan Shah (MSKCC)
Merav Bar (SCCA/FHCRC)

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