News

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

September is the time of the year where the Medicare rule season starts to wind down (hurray!) and we have a window of time to work on other efforts – coverage, coding and educational efforts being among them. This is a welcome change from the focus on scribing comment letters and a good time to reassess priorities before the end of the calendar year. 2018 has largely been the year of CAR-T on the health policy side, simply due to the frequency of new issues cropping up and the dollars at stake for the membership and your associated facilities. I am not anticipating a natural slowing of that work, but there is a strong need to recalibrate our efforts to include more work on HCT. We will hopefully be able to take strides towards expanded coverage for HCT for autoimmune diseases and post-HCT immunizations before the snow melts next spring.

MEDCAC Holds Meeting on CAR-T Payments

CMS convened its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel on Aug. 22 for a day-long discussion of the usefulness of patient-reported outcomes (PROs) as part of a potential National Coverage Determination (NCD) for CAR-T therapy. ASBMT worked with five individuals prior to the meeting to prepare comments and submit materials to CMS, all of which were accepted for presentation at the meeting. The ASBMT representatives were Surbhi Sidana (Mayo), Gunjan Shah (MSKCC), Heather Jim (Moffitt), Kathryn Flynn (MCW/CIBMTR), and Merav Bar (FHCRC/SCCA). They all did an outstanding job in their presentations and thoughtfully handled follow-up questions from the panel. CIBMTR is considering a coordinated effort to identify the most useful PROs for CAR-T patients and they will share more information after internal discussion on the topic.

All presentations, information on panel members, and final voting documents are available on the tracking website for MEDCAC and CAR-T. We will not know the effect of this meeting on the coverage process until the draft documents are released in February 2019. All information on the CMS national decision process is available on the main CAR-T NCA page.

On the coverage note, some of you may have read Dr. Peter Bach’s recent article in the New England Journal of Medicine regarding his suggestions to Medicare on CAR-T coverage. While well intended, the framework of Coverage with Evidence Development is very resource-intensive to the provider community while creating several unintended barriers to care; the required studies would be lengthy, unfunded and require difficult participation decisions on the part of centers. The ASBMT will be joining CIBMTR for a meeting with the CMS Coverage and Analysis Group in early September to voice these concerns and provide suggestions for the CAG team for the remainder of the NCA process.

HOP Panel Meets on Coding & Payment Issues

Medicare’s Advisory Panel on Hospital Outpatient Payment (HOP) held a meeting on Aug. 20 to review a number of outpatient coding and payment issues. ASBMT had submitted a request for CMS to change the status indicators assigned to the new CAR-T Current Procedural Terminology (CPT) codes in the Outpatient Prospective Payment System (OPPS) proposed rule. Jugna Shah from Nimitt Consulting presented on behalf of ASBMT and secured a very positive response from the panel, which recommended that CMS pay separately for the new CAR-T codes and use the transplant codes as benchmarks for payment levels.

Meeting materials are posted on the HOP Panel site and the final recommendations will be posted in the next few weeks. CMS does not have to adopt the recommendations in the final rule, but a HOP Panel recommendation is very useful in supporting ASBMT’s request. The final status of the codes will be known in November, when the final OPPS rule for CY 2019 is released.

At the same HOP Panel meeting, the NMDP/Be The Match brought forward a request that CMS study the claims in its system for outpatient AutoHCT and consider implementing a bundled outpatient rate, known as a Comprehensive Ambulatory Payment Classification (C-APC), that would combine all of the separate services on the day of AutoHCT into one code and corresponding payment. This would be similar to what CMS did for Allogeneic HCT two years ago, and it would likely increase the payment rate substantially. The Panel did recommend that CMS study the issue and if CMS accepts, the claims review work would likely happen in 2019 for inclusion in the OPPS proposed rule for CY 2020.

Blue Distinction Centers Program Launches for CAR-T Therapy

On Aug. 2, the Blue Cross Blue Shield Association announced the launch of a new division of their Blue Distinction program focused on cellular immunotherapy. Blue Distinction is a national designation provided by BCBS plans to providers demonstrating exceptional expertise and quality specialty care. The new program “aims to improve patient outcomes and cost for members undergoing CAR-T therapies.”

In order to be considered for the Blue Distinction Centers for Cellular Immunotherapy – CAR-T Therapy distinction, providers must hit a series of metrics, including 13 Quality Selection Criteria, Business, Value, and Local Plan Criteria. Details on the criteria for consideration can be found here. CAR-T episodes of care defined by the program includes pre-CAR-T therapy including leukapheresis, conditioning, cell infusion with a 30-day post-treatment acute phase recovery, and general complication management and outcome monitoring post-treatment for either Kymriah or Yescarta treatments. The program will become available January 2019.

National Uniform Billing Committee Discuss Cell and Gene Therapy Coding Updates

On Aug. 7 and 8, the National Uniform Billing Committee (NUBC) held their bi-annual public meeting and reviewed a request ASBMT submitted previously for more detailed coding on inpatient claims. The changes would allow hospitals to specifically report cell and gene therapies on inpatient claims, creating clear data reflecting the products used and the costs associated with them.  The changes would support the potential future use of pass-through payments or other alternative payment mechanisms as the cell and gene therapy space evolves, as well as future negotiations with Medicare and other payers about the costs of care. The discussion at the meeting was largely positive and formal documentation will be forthcoming on the NUBC site in the next few weeks.

New Clinical Management Guidelines Released for Pediatric CAR-T Therapy

In August, Nature Reviews Clinical Oncology published comprehensive expert consensus guidelines for treating pediatric patients who receive CAR-T therapy for acute lymphoblastic leukemia. Researchers from the MD Anderson Cancer Center CAR-T Cell Therapy-Associated Toxicity (CARTOX) Program and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network Hematopoietic Stem Cell Transplantation (HSCT) Subgroup developed the document to outline the safe administration of CAR-T therapies. The guidelines include recommendations for the early recognition of cytokine release syndrome (CRS) and/or CAR-related encephalopathy syndrome (CRES), the management of these toxicities, long-term follow-up assessments, and ethical, nursing, and pharmacy considerations, among others.

Reminder: Comment Submission on Physician Fee Schedule and OPPS

As we reviewed last month, CMS released its proposals for the 2019 Medicare Physician Fee Schedule (MPFS) and the Quality Payment Program (QPP), as well as the 2019 Outpatient Prospective Payment System (OPPS). CMS is currently accepting public comment on both proposals, and we have outlined details on the comments below. Please note that the comment deadlines for the two proposals are different!

MPFS/QPP

• You can find the full proposal for the Physician Fee Schedule on the CMS website or the Federal Register.
• Comments are being accepted until Sept. 10. The final rule is expected sometime in late November, after CMS reviews all submitted comments. Comments can be submitted electronically at www.regulations.gov (search for CMS-1693-P) or go directly to the rule page.
• You can find ASBMT’s rundown of the rule in our August newsletter, but important provisions in the rule include changes to Evaluation and Management (E&M) coding, new codes for telehealth services, and modifications to the QPP low volume threshold.

OPPS

• The 2019 OPPS proposal can be found on the CMS website or the Federal Register.
• Comments are being accepted until Sept. 24. The final rule will also be expected in late November. As with MPFS, comments can be submitted electronically at www.regulations.gov (search for CMS-1695-P) or go directly to the rule page.
• Please reference our Town Hall slides for information relevant to HCT and CAR-T for your own organizational letters.

House Passes HSA and HIT Bills

On July 25, the House passed a pair of bills with implications for the administration of health savings accounts (HSAs) and the controversial health insurance tax (HIT).

H.R. 6199, the Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018, would increase flexibility for plans to cover services pre-deductible, and expand the roster of drugs that can be purchased through HSA funds. H.R. 6311, the Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018, would allow tax credits from the Affordable Care Act be used for the purchase of so-called “copper” plans, and increase the limit on contributions to HSAs.

The House also passed H.R. 184, the Protect Medical Innovation Act of 2018. The bill would permanently repeal the medical device excise tax imposed by the Affordable Care Act, which has been delayed several times since the ACA passed in 2010. Further details on the bills can be found in MedPageToday’s breakdown of the legislation.

HHS Issues Final Rule on Short-Term Health Plans

On July 31, the Department of Health and Human Services published its final rule on short-term, limited-duration health insurance plans. Short-term plans had been limited under the Obama administration to three months, which hoped to push individuals to longer-term insurance purchased through ACA marketplaces. Under the new rule, these plans could last as long as a year, and enrollees would be able to renew their short-term plans for a total of three years.

The Trump administration has argued that the newly expanded plans will increase choice for American consumers and help combat the high premiums and limited options curre0ntly available in the individual insurance market. However, the plans would be very limited in their coverage, and critics see them as insufficient for health insurance consumers who may not fully understand their plan. The final rule does require a notice provision for those who purchase short-term plans. Read more about the debate over short-term plans at HealthcareDive.

CMS Proposes Overhaul of ACO Program

On Aug. 9, CMS issued a proposal for a new direction for the Medicare Shared Savings Program, called “Pathways to Success.” This would overhaul the current landscape for accountable care organizations (ACOs) in Medicare, eliminating the risk-free options for ACOs to “transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses).” The proposal would allow for a six-month extension for current ACOs and a one-time July 2019 start date for new participation options.

There are currently 561 ACOs in the Shared Savings Program, serving more than 10.5 million Medicare fee-for-service beneficiaries. Under the current system, there are three tracks available to ACOs, and the majority are enrolled in the one-sided shared savings-only model, which eliminates financial risk for participating organizations. CMS hopes to increase savings and quality in Medicare by shifting all ACOs to the two-sided models, where participants receive a larger share of the savings but are required to share losses as well if their spending exceeds the benchmark.

The new tracks, BASIC and ENHANCED, would include increased regulatory flexibility, including telehealth payment revisions, expanded waiver eligibility for skilled nursing facilities (SNFs), and beneficiary incentive programs. Additionally, CMS is proposing to establish new electronic health record (EHR) and interoperability requirements for ACOs, and seeking comment on developing meaningful ACO measures, addressing opioid utilization, and incentivizing collaboration between Medicare ACOs and Part D prescription drug plans.

Senate Passes Labor, HHS Appropriations Bill for 2019

On Aug. 23, the Senate voted to pass a “minibus” appropriations bill, which included FY 2019 appropriations for the Departments of Defense, Education, Labor, and Health and Human Services. The measure needs to be reconciled with the more partisan House version, but there are several health provisions worth highlighting. ASBMT will continue to monitor the progress of the appropriations process. The move comes ahead of the September 30 funding deadline, when a government shutdown would happen if the appropriations process is not signed by the White House or extended with a continuing resolution.

• The National Institutes of Health would receive an increase of $2.3 billion, or 5.4 percent.
• The bill includes a grant to HHS to develop and implement regulations on price transparency, which would require drug companies to provide list prices in TV ads.
• Amendments focusing on defunding Planned Parenthood were narrowly defeated.
• The All of Us Research Program would receive $376 million, an increase of $86 million.
• Opioid-related programs would receive a total of $3.7 billion.

ICYMI

Drug Pricing Policy: HHS Introduces Step Therapy in Medicare Advantage – Health Affairs breaks down the potential impact of CMS’ announcement allowing Medicare Advantage plans to implement step therapy for physician-administered Part B drugs.

The Large Hidden Costs of Medicare’s Prescription Drug Program – The New York Times Upshot outlines the disconnect between Medicare Part D premiums and reinsurance costs, and explores the perverse incentives for insurance companies to push enrollees into the co-called “catastrophic” spending threshold.

Commercial, Provider Concerns with Payment, Administration of CAR-T Therapies – The Journal of Clinical Pathways interviewed Gary Goldstein of Stanford Health’s Blood and Marrow Transplant Program. Goldstein addresses inpatient versus outpatient settings for CAR-T, Medicare reimbursement, and other emerging issues with treatment.

CVS’ Move to Lean on ICER Data Could Mean Dramatic Shift in Drug Pricing Leverage – FiercePharma details CVS Caremark’s decision to allow clients to exclude drugs based on data from the Institute of Clinical and Economic Review, and delves into the response from the pharmaceutical industry.